{
  "ticker": "VRTX",
  "company": "Vertex Pharmaceuticals Inc.",
  "filing_type": "10-K",
  "year_current": "2026",
  "year_prior": "2025",
  "summary": {
    "added": 92,
    "removed": 42,
    "modified": 17,
    "unchanged": 0,
    "total_current": 109,
    "total_prior": 59
  },
  "source": "SEC EDGAR",
  "url": "https://riskdiff.com/vrtx/2026-vs-2025/",
  "markdown_url": "https://riskdiff.com/vrtx/2026-vs-2025/index.md",
  "json_url": "https://riskdiff.com/vrtx/2026-vs-2025/index.json",
  "generated": "2026-06-01",
  "ai_summary": null,
  "risks": [
    {
      "status": "ADDED",
      "current_title": "be materially harmed.",
      "prior_title": null,
      "current_body": "A portion of the value attributed to our company by investors is based on the expected commercial success of JOURNAVX for acute pain and on our development programs for both acute and peripheral neuropathic pain. JOURNAVX may not gain or maintain market acceptance among physicians, patients, or payors due to various factors, including the availability of lower-cost alternatives, and sales, marketing, pricing, and/or distribution challenges associated with introducing a product into a highly competitive market. Furthermore, we may not succeed in developing JOURNAVX for additional indications or in advancing other product candidates, including NaV1.8 or NaV1.7 inhibitors, for the treatment of acute or peripheral neuropathic pain. Even if we obtain marketing approvals for these product candidates, they will face significant competition and there can be no assurance of commercial success."
    },
    {
      "status": "ADDED",
      "current_title": "We may not be able to increase or maintain CASGEVY product revenues.",
      "prior_title": null,
      "current_body": "The future commercial success of CASGEVY depends on physicians, patients, or payors accepting it as medically useful, cost-effective, ethical, safe, and preferred with respect to current and potential future competitive therapies, and on 26payors providing adequate reimbursement. In addition to risks generally associated with the commercialization of medicines, the cell collection processes, manufacturing and other procedures required to manufacture and administer CASGEVY are more complex, resource-intensive, and operationally demanding than for small molecules. For example, the cost of manufacturing CASGEVY as a percentage of revenue is significantly higher than for our CF medicines. Moreover, market acceptance continues to be dependent in part on the prevalence and severity of side effects associated with the procedure by which CASGEVY is administered, including those resulting from the myeloablative preconditioning regime. There can be no assurance that we will be able to increase or maintain our revenues from CASGEVY in future periods.Risks Related to CommercializationWe are subject to pricing and reimbursement pressures that could have a material adverse effect on our business, revenues, and results of operations. Revenues from our products depend, to a large degree, on the extent to which the products are purchased by customers, such as wholesalers, pharmacies, and hospitals, and reimbursed by third-party payors, such as government health programs, commercial insurers, and managed health care organizations. Increasingly, these third-party payors are becoming more critical in evaluating and reimbursing medicines. The containment of health care costs continues to be a priority for many governments, and drug pricing has been a focus in this effort. The U.S. federal government and state legislatures and foreign governments have shown significant and evolving interest in implementing cost-containment programs, including price controls, restrictions on reimbursement, value-based and reference pricing, compulsory licensing, including the pursuit of so-called “march in” rights, and mandatory substitution with generic products, all of which could limit the prices of, or access to, our products. Decisions by third-party payors to not cover a product or restrict access to a product may shift over time and could reduce market acceptance of the product and limit product revenues. We must also compete to be placed on formularies of managed care providers, as exclusion of our products from a formulary would limit usage by managed care providers and patients.In the U.S., pricing and access is primarily governed by practices of private managed care providers and institutional and governmental purchasers, federal laws and regulations related to Medicare and Medicaid, including the ACA and the IRA, and state activities, including the establishment of PDABs and price transparency rules. For example, in August 2023, the Colorado PDAB selected five drugs for an affordability review, including TRIKAFTA. Although the Colorado PDAB later found TRIKAFTA to be ineligible for an upper payment limit we cannot predict whether future reviews by the Colorado PDAB, or any other PDAB, will come to the same conclusion about TRIKAFTA or any of our other therapies, or the amount of any potential upper payment limit. Furthermore, changes to the health care system enacted as part of health care reform in the U.S., as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private payors, could result in further pricing pressures. For example, initiatives by the U.S. government to impose most-favored-nation pricing on U.S. prescription drug prices in government programs, including the recently proposed GUARD Model by the CMS. While there is significant uncertainty around the related executive orders and rulemaking, mandatory initiatives could result in reduced pricing and reimbursement for our products.In most markets outside of the U.S., the pricing and reimbursement medicines is subject to governmental control and governments are making greater efforts to reduce drug prices and limit drug spending. The reimbursement process in ex-U.S. markets vary widely and can take a significant time to complete, and reimbursement decisions are made on a country-by-country and region-by-region basis. Reimbursement for our products by governments, including the timing of any reimbursements, may also be affected by budgetary or political constraints, particularly in challenging economic environments. We have experienced challenges in obtaining timely reimbursement for our products in various countries outside the U.S., and our future revenues depend on maintaining such reimbursement. There is no assurance that coverage and reimbursement will continue for our current products or be available for our future products. Even if reimbursement is available, there is no assurance that the timing or level of reimbursement will be sufficient. Furthermore, many ex-U.S. governments are introducing new legislation focused on cost containment measures applicable to the pharmaceutical industry; such legislation, if finalized, could lead to lower prices, rebates or other forms of discounts or special taxes.Our failure to obtain or maintain adequate prices, coverage, or reimbursement for our products would have an adverse effect on our business, revenue and results of operations, could curtail or eliminate our ability to adequately fund our research and development programs and/or could cause a decline or volatility in our stock price. 26 26 26 payors providing adequate reimbursement. In addition to risks generally associated with the commercialization of medicines, the cell collection processes, manufacturing and other procedures required to manufacture and administer CASGEVY are more complex, resource-intensive, and operationally demanding than for small molecules. For example, the cost of manufacturing CASGEVY as a percentage of revenue is significantly higher than for our CF medicines. Moreover, market acceptance continues to be dependent in part on the prevalence and severity of side effects associated with the procedure by which CASGEVY is administered, including those resulting from the myeloablative preconditioning regime. There can be no assurance that we will be able to increase or maintain our revenues from CASGEVY in future periods.Risks Related to CommercializationWe are subject to pricing and reimbursement pressures that could have a material adverse effect on our business, revenues, and results of operations. Revenues from our products depend, to a large degree, on the extent to which the products are purchased by customers, such as wholesalers, pharmacies, and hospitals, and reimbursed by third-party payors, such as government health programs, commercial insurers, and managed health care organizations. Increasingly, these third-party payors are becoming more critical in evaluating and reimbursing medicines. The containment of health care costs continues to be a priority for many governments, and drug pricing has been a focus in this effort. The U.S. federal government and state legislatures and foreign governments have shown significant and evolving interest in implementing cost-containment programs, including price controls, restrictions on reimbursement, value-based and reference pricing, compulsory licensing, including the pursuit of so-called “march in” rights, and mandatory substitution with generic products, all of which could limit the prices of, or access to, our products. Decisions by third-party payors to not cover a product or restrict access to a product may shift over time and could reduce market acceptance of the product and limit product revenues. We must also compete to be placed on formularies of managed care providers, as exclusion of our products from a formulary would limit usage by managed care providers and patients.In the U.S., pricing and access is primarily governed by practices of private managed care providers and institutional and governmental purchasers, federal laws and regulations related to Medicare and Medicaid, including the ACA and the IRA, and state activities, including the establishment of PDABs and price transparency rules. For example, in August 2023, the Colorado PDAB selected five drugs for an affordability review, including TRIKAFTA. Although the Colorado PDAB later found TRIKAFTA to be ineligible for an upper payment limit we cannot predict whether future reviews by the Colorado PDAB, or any other PDAB, will come to the same conclusion about TRIKAFTA or any of our other therapies, or the amount of any potential upper payment limit. Furthermore, changes to the health care system enacted as part of health care reform in the U.S., as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private payors, could result in further pricing pressures. For example, initiatives by the U.S. government to impose most-favored-nation pricing on U.S. prescription drug prices in government programs, including the recently proposed GUARD Model by the CMS. While there is significant uncertainty around the related executive orders and rulemaking, mandatory initiatives could result in reduced pricing and reimbursement for our products.In most markets outside of the U.S., the pricing and reimbursement medicines is subject to governmental control and governments are making greater efforts to reduce drug prices and limit drug spending. The reimbursement process in ex-U.S. markets vary widely and can take a significant time to complete, and reimbursement decisions are made on a country-by-country and region-by-region basis. Reimbursement for our products by governments, including the timing of any reimbursements, may also be affected by budgetary or political constraints, particularly in challenging economic environments. We have experienced challenges in obtaining timely reimbursement for our products in various countries outside the U.S., and our future revenues depend on maintaining such reimbursement. There is no assurance that coverage and reimbursement will continue for our current products or be available for our future products. Even if reimbursement is available, there is no assurance that the timing or level of reimbursement will be sufficient. Furthermore, many ex-U.S. governments are introducing new legislation focused on cost containment measures applicable to the pharmaceutical industry; such legislation, if finalized, could lead to lower prices, rebates or other forms of discounts or special taxes.Our failure to obtain or maintain adequate prices, coverage, or reimbursement for our products would have an adverse effect on our business, revenue and results of operations, could curtail or eliminate our ability to adequately fund our research and development programs and/or could cause a decline or volatility in our stock price. payors providing adequate reimbursement. In addition to risks generally associated with the commercialization of medicines, the cell collection processes, manufacturing and other procedures required to manufacture and administer CASGEVY are more complex, resource-intensive, and operationally demanding than for small molecules. For example, the cost of manufacturing CASGEVY as a percentage of revenue is significantly higher than for our CF medicines. Moreover, market acceptance continues to be dependent in part on the prevalence and severity of side effects associated with the procedure by which CASGEVY is administered, including those resulting from the myeloablative preconditioning regime. There can be no assurance that we will be able to increase or maintain our revenues from CASGEVY in future periods."
    },
    {
      "status": "ADDED",
      "current_title": "revenues, and results of operations.",
      "prior_title": null,
      "current_body": "Revenues from our products depend, to a large degree, on the extent to which the products are purchased by customers, such as wholesalers, pharmacies, and hospitals, and reimbursed by third-party payors, such as government health programs, commercial insurers, and managed health care organizations. Increasingly, these third-party payors are becoming more critical in evaluating and reimbursing medicines. The containment of health care costs continues to be a priority for many governments, and drug pricing has been a focus in this effort. The U.S. federal government and state legislatures and foreign governments have shown significant and evolving interest in implementing cost-containment programs, including price controls, restrictions on reimbursement, value-based and reference pricing, compulsory licensing, including the pursuit of so- called “march in” rights, and mandatory substitution with generic products, all of which could limit the prices of, or access to, our products. Decisions by third-party payors to not cover a product or restrict access to a product may shift over time and could reduce market acceptance of the product and limit product revenues. We must also compete to be placed on formularies of managed care providers, as exclusion of our products from a formulary would limit usage by managed care providers and patients. In the U.S., pricing and access is primarily governed by practices of private managed care providers and institutional and governmental purchasers, federal laws and regulations related to Medicare and Medicaid, including the ACA and the IRA, and state activities, including the establishment of PDABs and price transparency rules. For example, in August 2023, the Colorado PDAB selected five drugs for an affordability review, including TRIKAFTA. Although the Colorado PDAB later found TRIKAFTA to be ineligible for an upper payment limit we cannot predict whether future reviews by the Colorado PDAB, or any other PDAB, will come to the same conclusion about TRIKAFTA or any of our other therapies, or the amount of any potential upper payment limit. Furthermore, changes to the health care system enacted as part of health care reform in the U.S., as well as increased purchasing power of entities that negotiate on behalf of Medicare, Medicaid, and private payors, could result in further pricing pressures. For example, initiatives by the U.S. government to impose most-favored- nation pricing on U.S. prescription drug prices in government programs, including the recently proposed GUARD Model by the CMS. While there is significant uncertainty around the related executive orders and rulemaking, mandatory initiatives could result in reduced pricing and reimbursement for our products. In most markets outside of the U.S., the pricing and reimbursement medicines is subject to governmental control and governments are making greater efforts to reduce drug prices and limit drug spending. The reimbursement process in ex-U.S. markets vary widely and can take a significant time to complete, and reimbursement decisions are made on a country-by- country and region-by-region basis. Reimbursement for our products by governments, including the timing of any reimbursements, may also be affected by budgetary or political constraints, particularly in challenging economic environments. We have experienced challenges in obtaining timely reimbursement for our products in various countries outside the U.S., and our future revenues depend on maintaining such reimbursement. There is no assurance that coverage and reimbursement will continue for our current products or be available for our future products. Even if reimbursement is available, there is no assurance that the timing or level of reimbursement will be sufficient. Furthermore, many ex-U.S. governments are introducing new legislation focused on cost containment measures applicable to the pharmaceutical industry; such legislation, if finalized, could lead to lower prices, rebates or other forms of discounts or special taxes. Our failure to obtain or maintain adequate prices, coverage, or reimbursement for our products would have an adverse effect on our business, revenue and results of operations, could curtail or eliminate our ability to adequately fund our research and development programs and/or could cause a decline or volatility in our stock price. 27Competing products and technological advances from our competitors may negatively affect our business and market position. Our products and product candidates face or may face competition from existing and potential competing products. See also Item 1., Business – Competition of this Annual Report on Form 10-K. Competing products may be more effective, safer, more effectively marketed, have lower prices or better coverage or reimbursement levels, eliminate or minimize the need for treatment with our products or product candidates, or have other differentiating factors that negatively affect the demand for our products or product candidates. If a competitor obtains approval and reimbursement before we do, approval and/or reimbursement of our products or product candidates could be delayed, denied, or otherwise adversely affected. We compete with an array of companies and other organizations, including those that have substantially greater resources, more mature development, manufacturing and commercial organizations, and/or other competitive advantages. Smaller companies with innovative programs or technologies are frequently acquired by and enter into collaborations with larger competitors, which may result in the acceleration or enhancement of competitive programs. We cannot predict the timing or impact of the introduction of competitive products. If a competing product is successfully developed and commercialized for a patient population we are currently treating or are seeking to treat, our revenues, business or market position could be materially adversely affected. In addition, the release of new information, including clinical data and regulatory approval timelines, by our competitors regarding competitive products or potentially competitive product candidates can affect investors’ perceptions regarding the prospects of our products and product candidates, and has caused and may in the future cause our stock price to decline or experience periods of significant volatility.If we discover safety or efficacy issues with any of our products, commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed.After regulatory approval and launch, our products are used over longer periods of time and by larger populations of patients than during pre-approval clinical trials. Additional clinical and non-clinical studies, such as for label expansions, new combinations or otherwise, may also be conducted after regulatory approval. For example, as part of FDA approval for CASGEVY, we are required to conduct post-marketing safety studies to assess certain long-term risks associated with the treatment. Additionally, when post-marketing studies involve our marketed products, or an active pharmaceutical ingredient thereof, they can raise new safety issues for our existing products. The subsequent discovery or appearance of previously unknown or underestimated safety or efficacy concerns with a product could negatively affect commercial sales of the product, result in reduced coverage or reimbursement by payors, cause reputational harm, government investigations, and/or lawsuits against us. Subsequent adverse safety events, as well as safety or efficacy issues affecting suppliers or competing products, may also lead to recalls, denial or withdrawal of regulatory approvals, non-renewal of conditional regulatory approvals, label changes, obligations to conduct additional or more extensive clinical trials or to implement a risk management plan, and reductions in market acceptance. Each of our CF products shares at least one active pharmaceutical ingredient with another of our products. If any of our CF products were to experience safety issues or labeling modifications, our other CF products may be adversely affected. For example, in December 2024, the FDA required us to modify the TRIKAFTA label by revising information regarding liver injury and liver failure and moving that information from the “warnings and precautions” section to a “boxed warning” section; the FDA required similar language in the ALYFTREK label. In addition, safety or efficacy issues affecting suppliers’ or competitors’ products also may reduce the market acceptance of our products.The discovery of safety events involving our products or public speculation about such events could limit or reduce product revenues and cause our stock price to decline or experience periods of volatility. Risks Related to Product DevelopmentThe data from our product development activities may not support advancement or regulatory approval of our product candidates, or label expansions for our marketed products, or provide sufficient data to support the successful commercialization of our approved products.Extensive testing is required for our product candidates and for new indications of our marketed products. The outcomes of such clinical and non-clinical testing are highly uncertain, may not generate sufficient safety, efficacy, or other data, and may not support regulatory approval of our product candidates. Clinical and non-clinical testing, and in particular our later-stage clinical trials, are expensive and resource intensive. The data from our preclinical studies and other research activities have in the past and may in the future fail to predict results in clinical trials. For example, despite considerable non-clinical testing, the clinical study of VX-264 in T1D did not meet its efficacy endpoint. Similarly, results from earlier-stage clinical 27 27 27 Competing products and technological advances from our competitors may negatively affect our business and market position. Our products and product candidates face or may face competition from existing and potential competing products. See also Item 1., Business – Competition of this Annual Report on Form 10-K. Competing products may be more effective, safer, more effectively marketed, have lower prices or better coverage or reimbursement levels, eliminate or minimize the need for treatment with our products or product candidates, or have other differentiating factors that negatively affect the demand for our products or product candidates. If a competitor obtains approval and reimbursement before we do, approval and/or reimbursement of our products or product candidates could be delayed, denied, or otherwise adversely affected. We compete with an array of companies and other organizations, including those that have substantially greater resources, more mature development, manufacturing and commercial organizations, and/or other competitive advantages. Smaller companies with innovative programs or technologies are frequently acquired by and enter into collaborations with larger competitors, which may result in the acceleration or enhancement of competitive programs. We cannot predict the timing or impact of the introduction of competitive products. If a competing product is successfully developed and commercialized for a patient population we are currently treating or are seeking to treat, our revenues, business or market position could be materially adversely affected. In addition, the release of new information, including clinical data and regulatory approval timelines, by our competitors regarding competitive products or potentially competitive product candidates can affect investors’ perceptions regarding the prospects of our products and product candidates, and has caused and may in the future cause our stock price to decline or experience periods of significant volatility.If we discover safety or efficacy issues with any of our products, commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed.After regulatory approval and launch, our products are used over longer periods of time and by larger populations of patients than during pre-approval clinical trials. Additional clinical and non-clinical studies, such as for label expansions, new combinations or otherwise, may also be conducted after regulatory approval. For example, as part of FDA approval for CASGEVY, we are required to conduct post-marketing safety studies to assess certain long-term risks associated with the treatment. Additionally, when post-marketing studies involve our marketed products, or an active pharmaceutical ingredient thereof, they can raise new safety issues for our existing products. The subsequent discovery or appearance of previously unknown or underestimated safety or efficacy concerns with a product could negatively affect commercial sales of the product, result in reduced coverage or reimbursement by payors, cause reputational harm, government investigations, and/or lawsuits against us. Subsequent adverse safety events, as well as safety or efficacy issues affecting suppliers or competing products, may also lead to recalls, denial or withdrawal of regulatory approvals, non-renewal of conditional regulatory approvals, label changes, obligations to conduct additional or more extensive clinical trials or to implement a risk management plan, and reductions in market acceptance. Each of our CF products shares at least one active pharmaceutical ingredient with another of our products. If any of our CF products were to experience safety issues or labeling modifications, our other CF products may be adversely affected. For example, in December 2024, the FDA required us to modify the TRIKAFTA label by revising information regarding liver injury and liver failure and moving that information from the “warnings and precautions” section to a “boxed warning” section; the FDA required similar language in the ALYFTREK label. In addition, safety or efficacy issues affecting suppliers’ or competitors’ products also may reduce the market acceptance of our products.The discovery of safety events involving our products or public speculation about such events could limit or reduce product revenues and cause our stock price to decline or experience periods of volatility. Risks Related to Product DevelopmentThe data from our product development activities may not support advancement or regulatory approval of our product candidates, or label expansions for our marketed products, or provide sufficient data to support the successful commercialization of our approved products.Extensive testing is required for our product candidates and for new indications of our marketed products. The outcomes of such clinical and non-clinical testing are highly uncertain, may not generate sufficient safety, efficacy, or other data, and may not support regulatory approval of our product candidates. Clinical and non-clinical testing, and in particular our later-stage clinical trials, are expensive and resource intensive. The data from our preclinical studies and other research activities have in the past and may in the future fail to predict results in clinical trials. For example, despite considerable non-clinical testing, the clinical study of VX-264 in T1D did not meet its efficacy endpoint. Similarly, results from earlier-stage clinical"
    },
    {
      "status": "ADDED",
      "current_title": "Competing products and technological advances from our competitors may negatively affect our business and market",
      "prior_title": null,
      "current_body": "position. Our products and product candidates face or may face competition from existing and potential competing products. See also Item 1., Business – Competition of this Annual Report on Form 10-K. Competing products may be more effective, safer, more effectively marketed, have lower prices or better coverage or reimbursement levels, eliminate or minimize the need for treatment with our products or product candidates, or have other differentiating factors that negatively affect the demand for our products or product candidates. If a competitor obtains approval and reimbursement before we do, approval and/or reimbursement of our products or product candidates could be delayed, denied, or otherwise adversely affected. We compete with an array of companies and other organizations, including those that have substantially greater resources, more mature development, manufacturing and commercial organizations, and/or other competitive advantages. Smaller companies with innovative programs or technologies are frequently acquired by and enter into collaborations with larger competitors, which may result in the acceleration or enhancement of competitive programs. We cannot predict the timing or impact of the introduction of competitive products. If a competing product is successfully developed and commercialized for a patient population we are currently treating or are seeking to treat, our revenues, business or market position could be materially adversely affected. In addition, the release of new information, including clinical data and regulatory approval timelines, by our competitors regarding competitive products or potentially competitive product candidates can affect investors’ perceptions regarding the prospects of our products and product candidates, and has caused and may in the future cause our stock price to decline or experience periods of significant volatility."
    },
    {
      "status": "ADDED",
      "current_title": "non-monetary remedies.",
      "prior_title": null,
      "current_body": "The health care industry is highly regulated and subject to complex and increasing regulations. U.S. federal and state regulators, including the FDA and comparable ex-U.S. regulators directly regulate our most critical business activities, including those related to research, development, manufacturing, and commercialization, as described in Item 1, “Business – Government Regulation.” The process for obtaining regulatory approvals to market a product is costly and time consuming, and approvals may not be granted for future products, or additional indications of existing products, on a timely basis or at all. In addition, we cannot guarantee that we will remain compliant with applicable regulatory requirements once approval has been obtained. These requirements govern, among other things, our manufacturing practices, communications regarding our products, and reporting of safety events. Maintaining compliance with these extensive regulations is complex, expensive, and time consuming, and failure to comply may result in additional regulatory actions, including recalls, withdrawal or suspension of product approvals, civil and criminal charges, reputational harm, and fines, penalties, or other monetary or non-monetary remedies, including exclusion from receipt of payment from U.S. federal and state healthcare programs like Medicare and Medicaid. Compliance with the regulatory requirements for biologics and cell and gene therapies can be more burdensome, expensive and time-consuming than for other, better known or more extensively studied types of medicines, such as small molecules. Regulatory requirements governing cell and genetic therapy products have changed frequently and may continue to change in the future. Furthermore, risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic areas with different patient populations, which may require different commercialization activities from those we currently utilize. We expect that regulation of the healthcare industry will continue to evolve through political and legal action, as future proposals to reform healthcare systems are considered by U.S. and foreign governments and regulatory authorities. We cannot predict when additional changes in the healthcare industry in general, or the pharmaceutical industry in particular, will occur, or what the impact of such changes may be. For example, new proposals or requirements regarding local manufacturing of pharmaceutical products, enhanced data security and privacy measures, sustainability, importation restrictions, embargoes, or trade sanctions may negatively impact our business. In addition, our development and commercialization activities could be harmed or delayed by a shutdown of the U.S. government or events that affect the manner in which the FDA operates."
    },
    {
      "status": "ADDED",
      "current_title": "information.",
      "prior_title": null,
      "current_body": "We market our products to health care providers and provide promotional materials and informational programs regarding the use of each product in these patient populations. In jurisdictions where permitted, we also market our products to patients for whom the applicable product has been approved, as well as to their caregivers. If a regulatory authority interprets any of our conduct, including our marketing practices or patient support programs, as promotion of unapproved uses or otherwise false and misleading, it could request that we modify or withdraw our promotional materials or issue corrective advertising. It could also take enforcement action, such as issuing warning or untitled letters, prohibiting certain of our activities, seizing products, and imposing civil fines and criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they believe that the alleged conduct led to the submission and payment of claims for unapproved uses of our product, which could result in significant fines or penalties. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters. Our interactions with health care providers that prescribe or purchase our products are also subject to laws and regulations designed to prevent fraud and abuse in the sale and use of medicines and that place significant restrictions on the marketing practices of biopharmaceutical companies. The relationships between companies and health care providers are 30scrutinized and have been the target of lawsuits and investigations alleging various problematic conduct, including submission of incorrect pricing information, improper promotion of pharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, and anticompetitive behavior. We are required to track and disclose financial interactions with health care providers and health care organizations, which may increase government and public scrutiny of these financial interactions. Failure to comply with these reporting requirements could result in significant civil monetary penalties. As we commercialize products for new patient populations and in new geographies, we will have more interactions with a broader set of healthcare providers and we must continue to expend significant efforts to establish, maintain and enhance systems and processes to comply with laws and regulations governing those interactions. Government price reporting and payment regulations are also complex, requiring us to continually assess the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation. If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability. If we are unable to obtain, maintain and enforce our intellectual property rights, our business could be harmed. Our success depends, in significant part, on our ability to obtain, maintain, and enforce patents and intellectual property rights such as trademarks and copyrights that protect our products, product candidates, and technologies. In addition, we rely upon trade secret protection and contractual arrangements to protect certain of our proprietary information. Due to the complexity of the legal standards and factual questions relating to the patentability, validity, and enforceability of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these patents, our ability to obtain, maintain and enforce our patents is uncertain. The initial grant of patents or regulatory exclusivity in the U.S. and ex-U.S. markets depends upon decisions of the patent offices, courts, and governments in those countries. We may fail to obtain, defend or otherwise preserve patent and other intellectual property rights, including certain forms of regulatory exclusivity, and our current intellectual property rights or protections and those we obtain in the future may not be broad enough or sufficient to protect our commercial interests in all countries where we conduct business. In the U.S. and ex-U.S. markets, third parties have challenged and may continue to challenge, invalidate, or circumvent our patents and patent applications relating to our products, product candidates, and technologies. We have had and may continue to have disputes with respect to the rights to products, product candidates, and technologies developed in collaboration with other parties. If we cannot resolve disputes and obtain adequate intellectual property right protections, we may not be able to develop or market our products. Settlements of such proceedings could also result in reducing the period of exclusivity and other protections, resulting in a reduction in revenue from affected products. Any litigation, including litigation related to Abbreviated New Drug Applications (“ANDA”), litigation related to 505(b)(2) applications, interference proceedings to determine priority of inventions, derivations proceedings, inter partes review, oppositions to patents in foreign countries, litigation against our collaborators, or similar actions, could harm our business.Difficulties in, or preclusion from, protecting our intellectual property rights in foreign jurisdictions could substantially harm our business. Third-party manufacturers may be able to sell generic versions of our products in countries that do not provide effective mechanisms for enforcement of our patents or other intellectual property rights. For example, we have experienced a violation of our intellectual property rights in Russia, where a copy product that infringes our patents has been made available. In addition, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties in certain circumstances. Compulsory licenses have been used in certain countries for market access purposes and, in some cases, as a cost-containment measure. Compulsory licenses issued for our patents may diminish or reduce revenue from those jurisdictions and negatively affect our results of operations. Third parties may also illegally distribute and sell counterfeit versions of our products. Copy or counterfeit products may not meet our rigorous manufacturing and testing standards and a patient who receives such product may be at risk for a number of dangerous health consequences. Our business and reputation could suffer harm as a result of illegally produced and distributed generic versions of our products, as well as counterfeit products sold under our brand name. The diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability. 30 30 30 scrutinized and have been the target of lawsuits and investigations alleging various problematic conduct, including submission of incorrect pricing information, improper promotion of pharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, and anticompetitive behavior. We are required to track and disclose financial interactions with health care providers and health care organizations, which may increase government and public scrutiny of these financial interactions. Failure to comply with these reporting requirements could result in significant civil monetary penalties. As we commercialize products for new patient populations and in new geographies, we will have more interactions with a broader set of healthcare providers and we must continue to expend significant efforts to establish, maintain and enhance systems and processes to comply with laws and regulations governing those interactions. Government price reporting and payment regulations are also complex, requiring us to continually assess the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation. If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability. If we are unable to obtain, maintain and enforce our intellectual property rights, our business could be harmed. Our success depends, in significant part, on our ability to obtain, maintain, and enforce patents and intellectual property rights such as trademarks and copyrights that protect our products, product candidates, and technologies. In addition, we rely upon trade secret protection and contractual arrangements to protect certain of our proprietary information. Due to the complexity of the legal standards and factual questions relating to the patentability, validity, and enforceability of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these patents, our ability to obtain, maintain and enforce our patents is uncertain. The initial grant of patents or regulatory exclusivity in the U.S. and ex-U.S. markets depends upon decisions of the patent offices, courts, and governments in those countries. We may fail to obtain, defend or otherwise preserve patent and other intellectual property rights, including certain forms of regulatory exclusivity, and our current intellectual property rights or protections and those we obtain in the future may not be broad enough or sufficient to protect our commercial interests in all countries where we conduct business. In the U.S. and ex-U.S. markets, third parties have challenged and may continue to challenge, invalidate, or circumvent our patents and patent applications relating to our products, product candidates, and technologies. We have had and may continue to have disputes with respect to the rights to products, product candidates, and technologies developed in collaboration with other parties. If we cannot resolve disputes and obtain adequate intellectual property right protections, we may not be able to develop or market our products. Settlements of such proceedings could also result in reducing the period of exclusivity and other protections, resulting in a reduction in revenue from affected products. Any litigation, including litigation related to Abbreviated New Drug Applications (“ANDA”), litigation related to 505(b)(2) applications, interference proceedings to determine priority of inventions, derivations proceedings, inter partes review, oppositions to patents in foreign countries, litigation against our collaborators, or similar actions, could harm our business.Difficulties in, or preclusion from, protecting our intellectual property rights in foreign jurisdictions could substantially harm our business. Third-party manufacturers may be able to sell generic versions of our products in countries that do not provide effective mechanisms for enforcement of our patents or other intellectual property rights. For example, we have experienced a violation of our intellectual property rights in Russia, where a copy product that infringes our patents has been made available. In addition, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties in certain circumstances. Compulsory licenses have been used in certain countries for market access purposes and, in some cases, as a cost-containment measure. Compulsory licenses issued for our patents may diminish or reduce revenue from those jurisdictions and negatively affect our results of operations. Third parties may also illegally distribute and sell counterfeit versions of our products. Copy or counterfeit products may not meet our rigorous manufacturing and testing standards and a patient who receives such product may be at risk for a number of dangerous health consequences. Our business and reputation could suffer harm as a result of illegally produced and distributed generic versions of our products, as well as counterfeit products sold under our brand name. The diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability. scrutinized and have been the target of lawsuits and investigations alleging various problematic conduct, including submission of incorrect pricing information, improper promotion of pharmaceutical products, payments intended to influence the referral of health care business, submission of false claims for government reimbursement, and anticompetitive behavior. We are required to track and disclose financial interactions with health care providers and health care organizations, which may increase government and public scrutiny of these financial interactions. Failure to comply with these reporting requirements could result in significant civil monetary penalties. As we commercialize products for new patient populations and in new geographies, we will have more interactions with a broader set of healthcare providers and we must continue to expend significant efforts to establish, maintain and enhance systems and processes to comply with laws and regulations governing those interactions. Government price reporting and payment regulations are also complex, requiring us to continually assess the methods by which we calculate and report pricing in accordance with these obligations. Our methodologies for calculations are inherently subject to assumptions and may be subject to review and challenge by various government agencies, which may disagree with our interpretation. If the government disagrees with our reported calculations, we may need to restate previously reported data and could be subject to additional financial and legal liability."
    },
    {
      "status": "ADDED",
      "current_title": "If we are not able to operate without infringing upon intellectual property rights of third parties, our business could be",
      "prior_title": null,
      "current_body": "harmed. Our competitors seek to protect their products, product candidates and proprietary information through patents, trademarks, trade secrets, and copyrights. Third parties have claimed and may claim in the future that our products or other activities infringe their intellectual property rights or that our employees have misappropriated their intellectual property rights. See also Item 1., Business – Intellectual Property of this Annual Report on Form 10-K. Resolving an intellectual property infringement or other claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms. A successful claim of patent infringement or other violation or misappropriation of intellectual property rights by a third party could subject us to significant damages and/or an injunction preventing the manufacture, sale, or use of the affected product or products, and/or require us to pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure."
    },
    {
      "status": "ADDED",
      "current_title": "including at our third-party providers.",
      "prior_title": null,
      "current_body": "We could be subject to significant supply interruptions for our commercial products or product candidates as a result of disruptions to our internal manufacturing capabilities or those of our suppliers or partners. Supply disruptions may result from a variety of factors, including shortages in product raw materials or labor, technical difficulties, regulatory inspections or restrictions, delays in construction, regulatory approval, and inspection of new facilities or the expansion of existing facilities, shipping or customs delays, inability to maintain compliance with quality or other regulations, including cGMP requirements, general global supply chain disruptions, and performance failures by us or any third-party manufacturer on which we rely. Disruption in our supply chain or manufacturing capabilities can result in shipment delays, inventory shortages, lot failures, product withdrawals, recalls and other interruptions in the commercial and clinical supply of our products and product candidates. Any such disruption with respect to our commercial products could result in a failure to meet market demand, could negatively affect our patients, could reduce our net product revenues and/or increase our costs. Any such disruption in the supply of product candidates to our clinical trials could negatively affect the subjects enrolled in our clinical trials and/or cause delays in our clinical trials and applications for regulatory approval. Additionally, unfavorable geopolitical events could affect our ability to interact with or conduct business with specific vendors within our global supply network or could prevent or delay the transportation of supplies or products to their planned destination. For example, we depend on China-based suppliers for portions of our supply chain. Finding alternative suppliers due to geopolitical developments or otherwise may not be feasible or could take a significant amount of time and involve significant expense due to the nature of our products and the need to obtain regulatory approvals."
    },
    {
      "status": "ADDED",
      "current_title": "product candidates and manufacture our products would be harmed.",
      "prior_title": null,
      "current_body": "We continue to invest in and expand our manufacturing capabilities and supplier relationships to ensure the stability of our supply chains and to support the anticipated demand for our products. Establishing, managing and expanding our global manufacturing capabilities and supply chain, particularly as we enter new therapeutic modalities, requires significant financial commitment. This includes the creation and maintenance of numerous third-party contractual relationships upon which we rely. There can be no assurance that we will be able to identify, establish and maintain additional manufacturers or capacity for our product candidates and products on a timely basis, on commercially reasonable terms, or at all. The foregoing risks may be heightened where our products and the materials that we utilize in our operations are manufactured by only one supplier or at only one facility. In addition, in the course of providing its services, a contract manufacturer may develop process technology related to the manufacture of our products or product candidates that the manufacturer owns, either independently or jointly with us. This would increase our reliance on that manufacturer or require us to obtain a license from that manufacturer to have our products or product candidates manufactured by other suppliers utilizing the same process. In addition, we and our CMOs and corporate partners are subject to cGMP, as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies. Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with applicable regulatory requirements, including cGMP. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations. There can be no assurance that we or our CMOs and corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections. Furthermore, the manufacturing and logistics for drug products are highly complex and can require significant investment, including to scale-up manufacturing processes and to secure capacity at third parties with expertise to meet our requirements. This capacity may be limited by the number of other clinical trials and commercial manufacturing ongoing for other companies seeking similar support. There are many risks that could result in delays and additional costs, including the need to hire and train qualified employees and obtain access to necessary equipment and third-party technology. Additionally, even with relevant experience and expertise, drug manufacturers often encounter difficulties in scale-up and production, including difficulties with production costs and yields, quality control, and compliance with federal, state and foreign 33regulations, which can prevent manufacturers from completing clinical trials or commercializing products on a timely or profitable basis, if at all.Reliance on third-party relationships could adversely affect our business. Our business depends on relationships with third parties, including activities critical to research, development, manufacturing, commercialization, and technology. For example, we rely on third parties such as CROs for the day-to-day management and oversight of our clinical trials, on CMOs for active ingredient manufacturing and finishing operations, and on logistics providers for the distribution of our products. We are expanding our relationships with CROs, CMOs, and other third parties as we enter markets in which we have no or limited experience. Failure by any of our third parties to meet their contractual, regulatory, or other obligations, any disruption in the relationship between Vertex and a third party upon whom we rely, or the failure of a third party to conduct activities in accordance with our expectations, could adversely affect the relevant research, development, manufacturing, commercial, or administrative activity and our business. The foregoing risks may be heightened as a result of the limited number or specialized nature of certain third parties, as we may not be able to replace such third party in a timely manner, on commercially reasonable terms, or at all.The third parties upon which we rely are subject to their own operational and financial risks, as well as other difficulties, which, if realized, could negatively affect our business. If any of our third parties violate, or are alleged to have violated, any laws or regulations, including anti-corruption or anti-bribery regulations, the GDPR, or other laws and regulations, during the performance of their obligations to us, we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences. If we fail to scale our operations to accommodate growth, our business may suffer. As we continue to expand our global operations and capabilities, we face increasing demands on our management and infrastructure. To effectively manage our growing business, we need to: •implement and clearly communicate corporate-wide strategies and effectively prioritize resources;•enhance our operational and financial infrastructure, including data and information controls;•effectively leverage technology and automation where appropriate to enable efficient growth and remain competitive;•improve our administrative, financial and management processes, including decision-making processes and budget prioritization;•effectively grow, train and manage our global employee base; and•expand our compliance and legal resources.A variety of risks associated with operating in foreign countries could materially adversely affect our business.Our global operations subject us to risks that could adversely affect our business and revenue. In addition to the ex-U.S. risks we face with respect to compliance with local laws and regulatory requirements, pricing and reimbursement, intellectual property, manufacturing capabilities and supply chain, foreign exchange risks, and reliance on third parties, risks associated with operating a global biotechnology company include the potential for:•economic weakness, including recession and inflation, or political instability globally or with respect to particular foreign economies and markets;•business interruptions resulting from geo-political actions, including war and terrorism;•import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions, the risks of which appear to have increased in the current political environment; •credit risks related to our customers, which may be higher in less developed markets; and•global or regional public health emergencies. 33 33 33 regulations, which can prevent manufacturers from completing clinical trials or commercializing products on a timely or profitable basis, if at all.Reliance on third-party relationships could adversely affect our business. Our business depends on relationships with third parties, including activities critical to research, development, manufacturing, commercialization, and technology. For example, we rely on third parties such as CROs for the day-to-day management and oversight of our clinical trials, on CMOs for active ingredient manufacturing and finishing operations, and on logistics providers for the distribution of our products. We are expanding our relationships with CROs, CMOs, and other third parties as we enter markets in which we have no or limited experience. Failure by any of our third parties to meet their contractual, regulatory, or other obligations, any disruption in the relationship between Vertex and a third party upon whom we rely, or the failure of a third party to conduct activities in accordance with our expectations, could adversely affect the relevant research, development, manufacturing, commercial, or administrative activity and our business. The foregoing risks may be heightened as a result of the limited number or specialized nature of certain third parties, as we may not be able to replace such third party in a timely manner, on commercially reasonable terms, or at all.The third parties upon which we rely are subject to their own operational and financial risks, as well as other difficulties, which, if realized, could negatively affect our business. If any of our third parties violate, or are alleged to have violated, any laws or regulations, including anti-corruption or anti-bribery regulations, the GDPR, or other laws and regulations, during the performance of their obligations to us, we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences. If we fail to scale our operations to accommodate growth, our business may suffer. As we continue to expand our global operations and capabilities, we face increasing demands on our management and infrastructure. To effectively manage our growing business, we need to: •implement and clearly communicate corporate-wide strategies and effectively prioritize resources;•enhance our operational and financial infrastructure, including data and information controls;•effectively leverage technology and automation where appropriate to enable efficient growth and remain competitive;•improve our administrative, financial and management processes, including decision-making processes and budget prioritization;•effectively grow, train and manage our global employee base; and•expand our compliance and legal resources.A variety of risks associated with operating in foreign countries could materially adversely affect our business.Our global operations subject us to risks that could adversely affect our business and revenue. In addition to the ex-U.S. risks we face with respect to compliance with local laws and regulatory requirements, pricing and reimbursement, intellectual property, manufacturing capabilities and supply chain, foreign exchange risks, and reliance on third parties, risks associated with operating a global biotechnology company include the potential for:•economic weakness, including recession and inflation, or political instability globally or with respect to particular foreign economies and markets;•business interruptions resulting from geo-political actions, including war and terrorism;•import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions, the risks of which appear to have increased in the current political environment; •credit risks related to our customers, which may be higher in less developed markets; and•global or regional public health emergencies. regulations, which can prevent manufacturers from completing clinical trials or commercializing products on a timely or profitable basis, if at all."
    },
    {
      "status": "ADDED",
      "current_title": "Reliance on third-party relationships could adversely affect our business.",
      "prior_title": null,
      "current_body": "Our business depends on relationships with third parties, including activities critical to research, development, manufacturing, commercialization, and technology. For example, we rely on third parties such as CROs for the day-to-day management and oversight of our clinical trials, on CMOs for active ingredient manufacturing and finishing operations, and on logistics providers for the distribution of our products. We are expanding our relationships with CROs, CMOs, and other third parties as we enter markets in which we have no or limited experience. Failure by any of our third parties to meet their contractual, regulatory, or other obligations, any disruption in the relationship between Vertex and a third party upon whom we rely, or the failure of a third party to conduct activities in accordance with our expectations, could adversely affect the relevant research, development, manufacturing, commercial, or administrative activity and our business. The foregoing risks may be heightened as a result of the limited number or specialized nature of certain third parties, as we may not be able to replace such third party in a timely manner, on commercially reasonable terms, or at all. The third parties upon which we rely are subject to their own operational and financial risks, as well as other difficulties, which, if realized, could negatively affect our business. If any of our third parties violate, or are alleged to have violated, any laws or regulations, including anti-corruption or anti-bribery regulations, the GDPR, or other laws and regulations, during the performance of their obligations to us, we could suffer financial and reputational harm or other negative outcomes, including possible legal consequences."
    },
    {
      "status": "ADDED",
      "current_title": "adversely affect our business.",
      "prior_title": null,
      "current_body": "We maintain and rely extensively on information technology systems and network infrastructures, internally and with third parties for the effective operation of our business. We collect, store, and transmit confidential information, including personal information, financial information and intellectual property. Disruption, infiltration, or failure of our information technology systems because of software or hardware malfunctions, computer viruses, cyber-attacks, employee theft or misuse, power disruptions, natural disasters or accidents could cause breaches of data security and/or loss of critical data, which in turn could materially adversely affect our business. Cyber-attacks and incidents are increasing in their frequency, sophistication, and intensity, and are difficult to detect. Cyber-attacks are carried out by well-resourced groups and individuals with a wide range of motives and expertise. Due to the nature of some cyber-attacks and incidents, there is a risk that they may remain undetected for a period of time. Recent developments in the threat landscape include the use of adversarial artificial intelligence techniques and machine learning, as well as an increased number of cyber extortion attacks with higher financial ransom demand amounts and increasing sophistication and variety of ransomware techniques. Cyber-attacks and incidents also include manufacturing, hardware or software supply chain attacks, which could cause disruption to or a delay in the manufacturing of our products or product candidates, or lead to data privacy or security breach. We use cloud technologies and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks or data privacy incidents could disrupt our operations and result in misappropriation, corruption, or loss of confidential or proprietary information. The third parties upon which we rely face similar risks and when they experience a security breach of their systems, our security can be adversely affected. Like many companies, we have experienced immaterial cybersecurity incidents, including temporary service interruptions of third-party suppliers. There can be no assurance that our efforts to protect our data and information systems will prevent breakdowns or breaches in our systems that could adversely affect our business. While we maintain cyber liability insurance, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems and those of critical third parties. Cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws. In addition, we face certain risks as we seek to leverage artificial intelligence to optimize productivity and efficiency in various aspects of the organization. Flaws, biases, or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting our operations, financial condition, and reputation. Ethical and legal challenges may arise, including biases or discrimination in generated outcomes, non-compliance with data protection regulations and laws specifically governing the use of artificial intelligence systems and tools, and lack of transparency. Furthermore, the deployment of artificial intelligence systems could expose us to increased cybersecurity threats, such as data breaches and unauthorized access. We also face competitive risks if we do not implement artificial intelligence or other machine learning technologies in a timely fashion. 35Our operations may be disrupted by the occurrence of a natural disaster, catastrophic event, or by other serious accidents occurring at our facilities. Most of our operations, including our research and development activities, are conducted in a limited number of facilities. If any of our major facilities were to experience a catastrophic loss due to an earthquake, flood, severe storms, fire or similar event, our operations would be seriously harmed. For example, our corporate headquarters, as well as additional leased space that we use for certain logistical and laboratory operations and manufacturing, are located in a flood zone along the Massachusetts coast. If we are unable to effectively implement our business continuity plans, we may experience delays in recovery of data and/or an inability to perform vital corporate functions, which could result in a significant disruption in our operations, large expenses to repair or replace the facility and/or the loss of critical data. Additionally, we use hazardous materials in some of our facilities, and any accident, injury or other loss related thereto could result in substantial liability. Our property or other relevant insurance may not be sufficient to cover all potential losses that may result from an interruption to our operations or damage resulting from these risks.Strategic and Financial RisksOur business development strategy, including strategic transactions and collaborations, may not be successful, and there may be delays or failures in realizing the anticipated benefits of these activities.As part of our business strategy, we seek to enter into strategic transactions to acquire, license, or collaborate with other entities, in each case that have potential to complement and advance our ongoing research, development, manufacturing, and commercialization efforts. Over the last several years we have engaged in a number of strategic transactions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, as well as several smaller transactions and collaboration arrangements. See also Item 1., Business – Strategic Transactions of this Annual Report on Form 10-K. Our future transactions and collaborations may be similar to prior transactions, may be structured differently from prior transactions, or may involve larger transactions or later-stage assets. We face significant competition for potential strategic transactions and collaborations from a variety of other companies, some of which have significantly more financial resources and experience in business development activities. We may not complete future transactions in a timely manner, or at all, including due to the possibility that a governmental entity or regulatory body may delay or refuse to grant approval for the consummation of the transaction. We may not realize the anticipated benefits of our completed or future strategic transactions. The product candidates or products contemplated by those transactions may be delayed or terminated at any point during research or clinical development. Even if a product is approved, we may not be able to successfully commercialize it. As a result, we may fail to generate expected revenue growth or income contribution within the anticipated timeframe or at all. We also face risks that we: •may not effectively integrate acquired assets or businesses into our ongoing business;•may incur additional expenses or fail to achieve anticipated cost savings related to the strategic transactions; •may incur impairment charges related to assets acquired in any such transactions; or •may acquire unanticipated liabilities. In addition, future strategic transactions could result in potentially dilutive issuances of equity securities or the incurrence of debt. We continue to collaborate with outside partners on research, development, manufacturing, and/or commercialization activities with respect to product candidates and products. We face the same research, development, manufacturing, and commercialization risks with respect to product candidates and products that are subject to collaborations as with product candidates and products that we have developed ourselves. We face additional risks in connection with our current and future collaborative arrangements, including with respect to the performance of the collaborator and their compliance with contractual obligations. 35 35 35 Our operations may be disrupted by the occurrence of a natural disaster, catastrophic event, or by other serious accidents occurring at our facilities. Most of our operations, including our research and development activities, are conducted in a limited number of facilities. If any of our major facilities were to experience a catastrophic loss due to an earthquake, flood, severe storms, fire or similar event, our operations would be seriously harmed. For example, our corporate headquarters, as well as additional leased space that we use for certain logistical and laboratory operations and manufacturing, are located in a flood zone along the Massachusetts coast. If we are unable to effectively implement our business continuity plans, we may experience delays in recovery of data and/or an inability to perform vital corporate functions, which could result in a significant disruption in our operations, large expenses to repair or replace the facility and/or the loss of critical data. Additionally, we use hazardous materials in some of our facilities, and any accident, injury or other loss related thereto could result in substantial liability. Our property or other relevant insurance may not be sufficient to cover all potential losses that may result from an interruption to our operations or damage resulting from these risks.Strategic and Financial RisksOur business development strategy, including strategic transactions and collaborations, may not be successful, and there may be delays or failures in realizing the anticipated benefits of these activities.As part of our business strategy, we seek to enter into strategic transactions to acquire, license, or collaborate with other entities, in each case that have potential to complement and advance our ongoing research, development, manufacturing, and commercialization efforts. Over the last several years we have engaged in a number of strategic transactions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, as well as several smaller transactions and collaboration arrangements. See also Item 1., Business – Strategic Transactions of this Annual Report on Form 10-K. Our future transactions and collaborations may be similar to prior transactions, may be structured differently from prior transactions, or may involve larger transactions or later-stage assets. We face significant competition for potential strategic transactions and collaborations from a variety of other companies, some of which have significantly more financial resources and experience in business development activities. We may not complete future transactions in a timely manner, or at all, including due to the possibility that a governmental entity or regulatory body may delay or refuse to grant approval for the consummation of the transaction. We may not realize the anticipated benefits of our completed or future strategic transactions. The product candidates or products contemplated by those transactions may be delayed or terminated at any point during research or clinical development. Even if a product is approved, we may not be able to successfully commercialize it. As a result, we may fail to generate expected revenue growth or income contribution within the anticipated timeframe or at all. We also face risks that we: •may not effectively integrate acquired assets or businesses into our ongoing business;•may incur additional expenses or fail to achieve anticipated cost savings related to the strategic transactions; •may incur impairment charges related to assets acquired in any such transactions; or •may acquire unanticipated liabilities. In addition, future strategic transactions could result in potentially dilutive issuances of equity securities or the incurrence of debt. We continue to collaborate with outside partners on research, development, manufacturing, and/or commercialization activities with respect to product candidates and products. We face the same research, development, manufacturing, and commercialization risks with respect to product candidates and products that are subject to collaborations as with product candidates and products that we have developed ourselves. We face additional risks in connection with our current and future collaborative arrangements, including with respect to the performance of the collaborator and their compliance with contractual obligations."
    },
    {
      "status": "ADDED",
      "current_title": "may be delays or failures in realizing the anticipated benefits of these activities.",
      "prior_title": null,
      "current_body": "As part of our business strategy, we seek to enter into strategic transactions to acquire, license, or collaborate with other entities, in each case that have potential to complement and advance our ongoing research, development, manufacturing, and commercialization efforts. Over the last several years we have engaged in a number of strategic transactions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, as well as several smaller transactions and collaboration arrangements. See also Item 1., Business – Strategic Transactions of this Annual Report on Form 10-K. Our future transactions and collaborations may be similar to prior transactions, may be structured differently from prior transactions, or may involve larger transactions or later-stage assets. We face significant competition for potential strategic transactions and collaborations from a variety of other companies, some of which have significantly more financial resources and experience in business development activities. We may not complete future transactions in a timely manner, or at all, including due to the possibility that a governmental entity or regulatory body may delay or refuse to grant approval for the consummation of the transaction. We may not realize the anticipated benefits of our completed or future strategic transactions. The product candidates or products contemplated by those transactions may be delayed or terminated at any point during research or clinical development. Even if a product is approved, we may not be able to successfully commercialize it. As a result, we may fail to generate expected revenue growth or income contribution within the anticipated timeframe or at all. We also face risks that we: •may not effectively integrate acquired assets or businesses into our ongoing business; •may incur additional expenses or fail to achieve anticipated cost savings related to the strategic transactions; •may incur impairment charges related to assets acquired in any such transactions; or •may acquire unanticipated liabilities. In addition, future strategic transactions could result in potentially dilutive issuances of equity securities or the incurrence of debt. We continue to collaborate with outside partners on research, development, manufacturing, and/or commercialization activities with respect to product candidates and products. We face the same research, development, manufacturing, and commercialization risks with respect to product candidates and products that are subject to collaborations as with product candidates and products that we have developed ourselves. We face additional risks in connection with our current and future collaborative arrangements, including with respect to the performance of the collaborator and their compliance with contractual obligations. 36Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken, and exposure to additional income tax liabilities could have a material impact on our future taxable income.Our effective tax rate is derived from a combination of applicable tax rates in the various places that we operate globally. Our effective tax rate may be different than experienced in the past due to numerous factors, including: •changes in the mix of our profitability from country to country;•tax authority examinations/audits of our tax filings; •adjustments to the value of our uncertain tax positions; •changes in accounting for income taxes; and •changes in tax laws or modifications of treaties in various jurisdictions. Any of these factors could cause us to experience an effective tax rate that is significantly different from previous periods or our current expectations. For example, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax laws in jurisdictions in which we operate, such as the enactments by both E.U. and non-E.U. member countries of a global minimum tax. We are subject to ongoing tax audits in various jurisdictions, and local tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the probable outcomes of these audits to determine the appropriateness of our tax provision, and we have established contingency reserves for material tax exposures. However, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax authorities will be resolved at a financial cost that does not exceed our related reserves and the actual outcomes of these disputes and other tax audits could have a material impact on our results of operations or financial condition.Changes in foreign currency rates, interest rate risks, the value of our investment portfolio, and inflation affect our results of operations and financial condition.Fluctuations in currency exchange rates and interest rates, changes in the value of our investment portfolio, and inflation have affected and will continue to affect our cash flows, results of operations, and financial condition. The exchange rates among our reporting currency, the U.S. dollar, and the currencies in which we do business are volatile and our efforts to mitigate against these risks may not be successful. We invest our available cash in a range of investments, including investments in cash equivalents and debt securities, and fluctuations in interest rates, among other factors, could materially negatively affect the value of this investment portfolio. In addition, systemic economic downturns, as well as inflationary pressures, such as those observed in recent periods, may adversely impact our business and financial results. See also Item 7A., Quantitative and Qualitative Disclosures About Market Risk of this Annual Report on Form 10-K. Future indebtedness could materially and adversely affect our financial condition, and the terms of our credit agreements impose restrictions on our business. If we borrow under our current credit agreement or any future credit agreements, or otherwise issue or incur additional debt, such indebtedness could have important consequences to our business. The credit agreement requires that we comply with certain financial covenants, including a consolidated leverage ratio covenant and negative covenants, restricting or limiting our ability and the ability of our subsidiaries to, among other things, incur additional indebtedness, grant liens, engage in certain investment, acquisition and disposition transactions, and enter into transactions with affiliates. As a result, we may be restricted from engaging in business activities that may otherwise improve our business. Failure to comply with the covenants could result in an event of default that could trigger acceleration of our indebtedness. If we incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase. There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable prices.In May 2025, our Board of Directors approved a share repurchase program pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock from time to time through open market or privately negotiated transactions, of which $618.5 million has been repurchased as of December 31, 2025. Our stock repurchases will depend 36 36 36 Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken, and exposure to additional income tax liabilities could have a material impact on our future taxable income.Our effective tax rate is derived from a combination of applicable tax rates in the various places that we operate globally. Our effective tax rate may be different than experienced in the past due to numerous factors, including: •changes in the mix of our profitability from country to country;•tax authority examinations/audits of our tax filings; •adjustments to the value of our uncertain tax positions; •changes in accounting for income taxes; and •changes in tax laws or modifications of treaties in various jurisdictions. Any of these factors could cause us to experience an effective tax rate that is significantly different from previous periods or our current expectations. For example, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax laws in jurisdictions in which we operate, such as the enactments by both E.U. and non-E.U. member countries of a global minimum tax. We are subject to ongoing tax audits in various jurisdictions, and local tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the probable outcomes of these audits to determine the appropriateness of our tax provision, and we have established contingency reserves for material tax exposures. However, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax authorities will be resolved at a financial cost that does not exceed our related reserves and the actual outcomes of these disputes and other tax audits could have a material impact on our results of operations or financial condition.Changes in foreign currency rates, interest rate risks, the value of our investment portfolio, and inflation affect our results of operations and financial condition.Fluctuations in currency exchange rates and interest rates, changes in the value of our investment portfolio, and inflation have affected and will continue to affect our cash flows, results of operations, and financial condition. The exchange rates among our reporting currency, the U.S. dollar, and the currencies in which we do business are volatile and our efforts to mitigate against these risks may not be successful. We invest our available cash in a range of investments, including investments in cash equivalents and debt securities, and fluctuations in interest rates, among other factors, could materially negatively affect the value of this investment portfolio. In addition, systemic economic downturns, as well as inflationary pressures, such as those observed in recent periods, may adversely impact our business and financial results. See also Item 7A., Quantitative and Qualitative Disclosures About Market Risk of this Annual Report on Form 10-K. Future indebtedness could materially and adversely affect our financial condition, and the terms of our credit agreements impose restrictions on our business. If we borrow under our current credit agreement or any future credit agreements, or otherwise issue or incur additional debt, such indebtedness could have important consequences to our business. The credit agreement requires that we comply with certain financial covenants, including a consolidated leverage ratio covenant and negative covenants, restricting or limiting our ability and the ability of our subsidiaries to, among other things, incur additional indebtedness, grant liens, engage in certain investment, acquisition and disposition transactions, and enter into transactions with affiliates. As a result, we may be restricted from engaging in business activities that may otherwise improve our business. Failure to comply with the covenants could result in an event of default that could trigger acceleration of our indebtedness. If we incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase. There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable prices.In May 2025, our Board of Directors approved a share repurchase program pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock from time to time through open market or privately negotiated transactions, of which $618.5 million has been repurchased as of December 31, 2025. Our stock repurchases will depend"
    },
    {
      "status": "ADDED",
      "current_title": "of operations and financial condition.",
      "prior_title": null,
      "current_body": "Fluctuations in currency exchange rates and interest rates, changes in the value of our investment portfolio, and inflation have affected and will continue to affect our cash flows, results of operations, and financial condition. The exchange rates among our reporting currency, the U.S. dollar, and the currencies in which we do business are volatile and our efforts to mitigate against these risks may not be successful. We invest our available cash in a range of investments, including investments in cash equivalents and debt securities, and fluctuations in interest rates, among other factors, could materially negatively affect the value of this investment portfolio. In addition, systemic economic downturns, as well as inflationary pressures, such as those observed in recent periods, may adversely impact our business and financial results. See also Item 7A., Quantitative and Qualitative Disclosures About Market Risk of this Annual Report on Form 10-K."
    },
    {
      "status": "ADDED",
      "current_title": "Our stock price is volatile.",
      "prior_title": null,
      "current_body": "Our stock price is subject to significant fluctuations. From January 1, 2025 to December 31, 2025, our common stock traded between $362.50 and $519.68 per share. Our future stock price could be significantly and adversely affected by: •announcements or investor analyst commentary regarding the clinical development of our product candidates as new information, including efficacy and safety information becomes available; •our financial guidance and/or financial results, including quarterly and annual fluctuations resulting from factors such as the timing and amount of our revenues and expenses; and •other factors including the risks described in these “Risk Factors.” Fluctuations in our stock price can result in substantial losses for shareholders. Following periods of volatility in the market price of a company’s securities, shareholder derivative lawsuits and securities class action litigation are common. Such litigation, if instituted against us or our officers and directors, could result in substantial costs and other harm to our business."
    },
    {
      "status": "ADDED",
      "current_title": "SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS",
      "prior_title": null,
      "current_body": "This Annual Report on Form 10-K, including the descriptions of our Business set forth in Part I, Item 1, our Risk Factors set forth in Part I, Item 1A, and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Part II, Item 7, contains forward-looking statements. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements may relate to: •our expectations regarding the amount of, timing of, and trends with respect to our financial performance, including revenues, costs and expenses, and other gains and losses; •our expectations regarding clinical trials, including expectations for patient enrollment, development timelines, the expected timing of data from our ongoing and planned clinical trials, and regulatory authority filings and other submissions for our therapies; •our beliefs, expectations, and plans with respect to the commercial launches of CASGEVY for the treatment of SCD and TDT, ALYFTREK for the treatment of CF, and JOURNAVX for the treatment of moderate-to-severe acute pain, and the anticipated launch of povetacicept for the treatment of IgAN; •our ability to maintain and obtain adequate reimbursement for our products and product candidates, our ability to launch, commercialize and market our products or any of our other therapies for which we obtain regulatory approval, and our ability to obtain label expansions for existing therapies; •our expectations regarding our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to receive our medicines and providing improved treatment options for people who are already eligible for one of our medicines, and our beliefs that the majority of people with CF will transition to ALYFTREK over time; •our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our therapies • for further investigation, clinical trials or potential use as a treatment, including with respect to povetacicept as a pipeline-in-a-product and as a potential best-in-class approach for the treatment of IgAN, pMN, and gMG; •the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development, support regulatory filings, or accelerate regulatory approval, including our plans to complete the full submission for potential accelerated approval of povetacicept in IgAN in the first half of 2026 and to share data from the interim analysis of the Phase 2/3 clinical trial of inaxaplin in AMKD in late 2026 or early 2027 and from the Phase 2 trial in people with AMKD in mid-2026; •our beliefs that ALYFTREK will provide additional clinical benefits to eligible people with CF, regarding the durable efficacy and effectiveness of CASGEVY as one-time functional cure for people with SCD and TDT, and regarding the clinical benefits of JOURNAVX without the evidence of the several limitations of other available therapies; •our plans to continue investing in our research and development programs, including anticipated timelines for our programs, and our strategy to develop our pipeline programs, alone or with third-party collaborators; •our beliefs regarding the approximate patient populations for the disease areas on which we focus; •the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, its potential to become a pipeline-in-a-product, and our expectations regarding our agreements with Zai, Ono and WuXi; •our expectations regarding the lower royalty burden for ALYFTREK; •our plans to expand, strengthen, and invest in our global supply chains and manufacturing infrastructure and capabilities, including for biologic and cell and gene therapies; •the effects of import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions; •potential business development activities, including the identification of potential collaborative partners or acquisition targets; 39•our ability to expand and protect our intellectual property portfolio and otherwise maintain exclusive rights to products;•our expectations or beliefs regarding any legal proceedings in which we are involved, including any litigation, arbitration or other similar proceedings involving our products, product candidates or activities;•the establishment, development and maintenance of collaborative relationships, including potential milestone payments or other obligations;•potential fluctuations in foreign currency exchange rates and the effectiveness of our foreign currency management program;•our expectations regarding the amount of cash to generated by operations, our cash balance and expected generation and interest income;•our expectations regarding our provision for or benefit from income taxes and the utilization of our deferred tax assets;•our ability to use our research programs to identify and develop new product candidates to address serious diseases and significant unmet medical needs; •the effectiveness of our governance, plans and strategy with respect to managing cybersecurity risks and other threats to our information technology systems;•our ability to effectively implement artificial intelligence systems and tools;•our ability to attract and retain skilled personnel;•our expectations involving governmental cost containment and other regulatory efforts;•our expectations surrounding the competitive landscape facing our products and product candidates; and•our liquidity and our expectations regarding the possibility of raising additional capital.Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements. These risks, uncertainties, and other factors include, but are not limited to, those described in our Risk Factors, set forth in Part I, Item 1A, and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange Commission.Any such forward-looking statements are made on the basis of our views and assumptions as of the date of the filing and are not estimates of future performance. Except as required by law, we undertake no obligation to publicly update any forward-looking statements. The reader is cautioned not to place undue reliance on any such statements. ITEM 1B.UNRESOLVED STAFF COMMENTSWe did not receive any written comments from the Securities and Exchange Commission prior to the date 180 days before the end of the fiscal year ended December 31, 2025 regarding our filings under the Securities Exchange Act of 1934, as amended, that have not been resolved.ITEM 1C.CYBERSECURITYRisk Management and StrategyWe recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to maintain the security, confidentiality, integrity, and availability of our business systems and confidential information, including personal information and intellectual property. Our cybersecurity program includes systems and processes for assessing, identifying and managing material risks from cybersecurity threats and include maintenance and monitoring of information security policies aligned with global regulatory controls and aligned with National Institute of Standards and Technology Cybersecurity Framework and System and Organization Controls 2. The program includes user and employee awareness of cyber policies and practices; information systems configuration management; third-party risk management systems; identity and information asset protection; infrastructure security systems; and cyber threat operations with continuous monitoring and threat hunting. This program also includes processes to oversee and identify material risks from cybersecurity threats associated with our use of third-party service providers. We engage a range of third-party experts in connection with various development, implementation, and maintenance activities related to our cybersecurity program, including audit and compliance, threat hunting, monitoring, and end-user support. 39 39 39 •our ability to expand and protect our intellectual property portfolio and otherwise maintain exclusive rights to products;•our expectations or beliefs regarding any legal proceedings in which we are involved, including any litigation, arbitration or other similar proceedings involving our products, product candidates or activities;•the establishment, development and maintenance of collaborative relationships, including potential milestone payments or other obligations;•potential fluctuations in foreign currency exchange rates and the effectiveness of our foreign currency management program;•our expectations regarding the amount of cash to generated by operations, our cash balance and expected generation and interest income;•our expectations regarding our provision for or benefit from income taxes and the utilization of our deferred tax assets;•our ability to use our research programs to identify and develop new product candidates to address serious diseases and significant unmet medical needs; •the effectiveness of our governance, plans and strategy with respect to managing cybersecurity risks and other threats to our information technology systems;•our ability to effectively implement artificial intelligence systems and tools;•our ability to attract and retain skilled personnel;•our expectations involving governmental cost containment and other regulatory efforts;•our expectations surrounding the competitive landscape facing our products and product candidates; and•our liquidity and our expectations regarding the possibility of raising additional capital.Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements. These risks, uncertainties, and other factors include, but are not limited to, those described in our Risk Factors, set forth in Part I, Item 1A, and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange Commission.Any such forward-looking statements are made on the basis of our views and assumptions as of the date of the filing and are not estimates of future performance. Except as required by law, we undertake no obligation to publicly update any forward-looking statements. The reader is cautioned not to place undue reliance on any such statements. ITEM 1B.UNRESOLVED STAFF COMMENTSWe did not receive any written comments from the Securities and Exchange Commission prior to the date 180 days before the end of the fiscal year ended December 31, 2025 regarding our filings under the Securities Exchange Act of 1934, as amended, that have not been resolved.ITEM 1C.CYBERSECURITYRisk Management and StrategyWe recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to maintain the security, confidentiality, integrity, and availability of our business systems and confidential information, including personal information and intellectual property. Our cybersecurity program includes systems and processes for assessing, identifying and managing material risks from cybersecurity threats and include maintenance and monitoring of information security policies aligned with global regulatory controls and aligned with National Institute of Standards and Technology Cybersecurity Framework and System and Organization Controls 2. The program includes user and employee awareness of cyber policies and practices; information systems configuration management; third-party risk management systems; identity and information asset protection; infrastructure security systems; and cyber threat operations with continuous monitoring and threat hunting. This program also includes processes to oversee and identify material risks from cybersecurity threats associated with our use of third-party service providers. We engage a range of third-party experts in connection with various development, implementation, and maintenance activities related to our cybersecurity program, including audit and compliance, threat hunting, monitoring, and end-user support. •our ability to expand and protect our intellectual property portfolio and otherwise maintain exclusive rights to products; •our expectations or beliefs regarding any legal proceedings in which we are involved, including any litigation, arbitration or other similar proceedings involving our products, product candidates or activities; •the establishment, development and maintenance of collaborative relationships, including potential milestone payments or other obligations; •potential fluctuations in foreign currency exchange rates and the effectiveness of our foreign currency management program; •our expectations regarding the amount of cash to generated by operations, our cash balance and expected generation and interest income; •our expectations regarding our provision for or benefit from income taxes and the utilization of our deferred tax assets; •our ability to use our research programs to identify and develop new product candidates to address serious diseases and significant unmet medical needs; •the effectiveness of our governance, plans and strategy with respect to managing cybersecurity risks and other threats to our information technology systems; •our ability to effectively implement artificial intelligence systems and tools; •our ability to attract and retain skilled personnel; •our expectations involving governmental cost containment and other regulatory efforts; •our expectations surrounding the competitive landscape facing our products and product candidates; and •our liquidity and our expectations regarding the possibility of raising additional capital. Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements. These risks, These risks, uncertainties, and other factors include, but are not limited to, those described in our Risk Factors, set forth in Part I, Item 1A, uncertainties, and other factors include, but are not limited to, those described in our Risk Factors, set forth in Part I, Item 1A, and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange Commission. Commission. Any such forward-looking statements are made on the basis of our views and assumptions as of the date of the filing and are not estimates of future performance. Except as required by law, we undertake no obligation to publicly update any forward-looking statements. The reader is cautioned not to place undue reliance on any such statements. ITEM 1B.UNRESOLVED STAFF COMMENTS We did not receive any written comments from the Securities and Exchange Commission prior to the date 180 days before the end of the fiscal year ended December 31, 2025 regarding our filings under the Securities Exchange Act of 1934, as amended, that have not been resolved. ITEM 1C.CYBERSECURITY Risk Management and Strategy Risk Management and Strategy We recognize the critical importance of developing, implementing, and maintaining robust cybersecurity measures to maintain the security, confidentiality, integrity, and availability of our business systems and confidential information, including personal information and intellectual property. Our cybersecurity program includes systems and processes for Our cybersecurity program includes systems and processes for assessing, identifying and managing material risks from cybersecurity threats and include maintenance and monitoring of information security policies aligned with global regulatory controls and aligned with National Institute of Standards and Technology Cybersecurity Framework and System and Organization Controls 2. The program includes user and employee awareness of cyber policies and practices; information systems configuration management; third-party risk management systems; identity and information asset protection; infrastructure security systems; and cyber threat operations with continuous monitoring and threat hunting. This program also includes processes to oversee and identify material risks from continuous monitoring and threat hunting. T his program also includes processes to oversee and identify material risks from cybersecurity threats associated with our use of third-party service providers. We engage a range of third-party experts in We engage a range of third-party experts in connection with various development, implementation, and maintenance activities related to our cybersecurity program, connection with various development, implementation, and maintenance activities related to our cybersecurity program, including audit and compliance, threat hunting, monitoring, and end-user support. including audit and compliance, threat hunting, monitoring, and end-user support. 40Our cybersecurity program is integrated into our overall risk management systems, including our annual enterprise risk management program, internal audit program, business continuity and crisis management programs, third-party risk management program, insurance risk management program, and employee compliance programs. As part of our overall risk management program, we maintain a global insurance portfolio with comprehensive cyber coverage. Our Chief Information Security Officer (“CISO”) and the Information Security function advises, consults with, or provides input to each of these programs to ensure that material risks from cybersecurity threats are appropriately assessed, identified, and managed. As of the date of this report, there have been no cybersecurity threats that have materially affected or are reasonably likely to materially affect our business, operations, or financial condition. Similar to other companies, we have experienced cybersecurity incidents, including temporary service interruptions of third-party suppliers. As of the date of this report, however, known cybersecurity incidents, individually or in aggregate, have not had a material impact on our company. Over the last three years, net expenses incurred from any information security breaches, including any penalties and settlements, are not material relative to our total revenue. For additional discussion on cybersecurity risks we face, see Item 1.A, Risk Factors – “A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business.” of this Annual Report on Form 10-KGovernanceWhile our board of directors has oversight responsibility for risk management generally, the Audit and Finance Committee (“Audit Committee”) is specifically responsible for overseeing our cybersecurity risk management program to ensure that cybersecurity risks are identified, assessed, managed, and monitored. Our CISO provides quarterly updates to the Audit Committee in this regard, and covers the state of our cybersecurity program, supported by key performance indicators across the range of cybersecurity functions related to risk management and governance, identity and information asset protection, core security and endpoint security, and cyber threat operations. These updates include descriptions of cybersecurity incidents of interest, including those associated with our third-party service providers; the board will be informed promptly of material risks from cybersecurity threats.We strive to create a culture of cybersecurity resilience and awareness and believe that cybersecurity is the responsibility of every employee and contractor. At the same time, primary responsibility for assessing, monitoring, and managing our cybersecurity risks lies with our CISO. Our CISO has more than 35 years of experience in security and information systems and spent 25 years with Raytheon Technologies, most recently as Chief Technology Officer of Cybersecurity, Special Missions, Training & Services. Our CISO supported the U.S. President's National Security Telecommunications Advisory Committee for more than 20 years, is a member of the Massachusetts Cybersecurity Strategy Council, and previously served as Chair of the Kogod Cybersecurity Governance Center at American University. He also served on the Rhode Island Homeland Security Advisory Board and was a member of various commercial cyber product councils.Our CISO oversees a team of skilled cybersecurity professionals who have Certified Information Systems Security Professional credentials, Global Information Assurance Certification from the SANS Institute, and other security and network certifications. The cybersecurity team monitors and evaluates our cybersecurity posture and performance on an ongoing basis, including through regular vulnerability scans, penetration tests, and threat intelligence feeds. The cybersecurity team uses various tools and methodologies to manage cybersecurity risk that are tested on a regular cadence, and assesses and evaluates cybersecurity incidents, escalating certain cybersecurity incidents to the CISO according to protocol. The CISO is continually informed regarding the performance of the cybersecurity program, as well as the latest developments in cybersecurity, including potential threats and innovative risk management techniques aligned with industry standards. The CISO reports to our Chief Digital and Information Officer, who is a Senior Vice President of the Company and reports directly to our Chief Operating and Financial Officer (“COFO”). Our COFO is an Executive Vice President and an executive officer of the Company, and reports directly to our CEO.ITEM 2.PROPERTIESCorporate HeadquartersWe lease approximately 1.1 million square feet of office and laboratory space at our corporate headquarters in Boston, Massachusetts in two buildings pursuant to two leases that we entered into in May 2011 and amended in August 2024 to, among other terms, extend the lease termination dates from December 2028 to June 2044. We have the option to extend the term of the leases for up to two additional ten-year periods. 40 40 40 Our cybersecurity program is integrated into our overall risk management systems, including our annual enterprise risk management program, internal audit program, business continuity and crisis management programs, third-party risk management program, insurance risk management program, and employee compliance programs. As part of our overall risk management program, we maintain a global insurance portfolio with comprehensive cyber coverage. Our Chief Information Security Officer (“CISO”) and the Information Security function advises, consults with, or provides input to each of these programs to ensure that material risks from cybersecurity threats are appropriately assessed, identified, and managed. As of the date of this report, there have been no cybersecurity threats that have materially affected or are reasonably likely to materially affect our business, operations, or financial condition. Similar to other companies, we have experienced cybersecurity incidents, including temporary service interruptions of third-party suppliers. As of the date of this report, however, known cybersecurity incidents, individually or in aggregate, have not had a material impact on our company. Over the last three years, net expenses incurred from any information security breaches, including any penalties and settlements, are not material relative to our total revenue. For additional discussion on cybersecurity risks we face, see Item 1.A, Risk Factors – “A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business.” of this Annual Report on Form 10-KGovernanceWhile our board of directors has oversight responsibility for risk management generally, the Audit and Finance Committee (“Audit Committee”) is specifically responsible for overseeing our cybersecurity risk management program to ensure that cybersecurity risks are identified, assessed, managed, and monitored. Our CISO provides quarterly updates to the Audit Committee in this regard, and covers the state of our cybersecurity program, supported by key performance indicators across the range of cybersecurity functions related to risk management and governance, identity and information asset protection, core security and endpoint security, and cyber threat operations. These updates include descriptions of cybersecurity incidents of interest, including those associated with our third-party service providers; the board will be informed promptly of material risks from cybersecurity threats.We strive to create a culture of cybersecurity resilience and awareness and believe that cybersecurity is the responsibility of every employee and contractor. At the same time, primary responsibility for assessing, monitoring, and managing our cybersecurity risks lies with our CISO. Our CISO has more than 35 years of experience in security and information systems and spent 25 years with Raytheon Technologies, most recently as Chief Technology Officer of Cybersecurity, Special Missions, Training & Services. Our CISO supported the U.S. President's National Security Telecommunications Advisory Committee for more than 20 years, is a member of the Massachusetts Cybersecurity Strategy Council, and previously served as Chair of the Kogod Cybersecurity Governance Center at American University. He also served on the Rhode Island Homeland Security Advisory Board and was a member of various commercial cyber product councils.Our CISO oversees a team of skilled cybersecurity professionals who have Certified Information Systems Security Professional credentials, Global Information Assurance Certification from the SANS Institute, and other security and network certifications. The cybersecurity team monitors and evaluates our cybersecurity posture and performance on an ongoing basis, including through regular vulnerability scans, penetration tests, and threat intelligence feeds. The cybersecurity team uses various tools and methodologies to manage cybersecurity risk that are tested on a regular cadence, and assesses and evaluates cybersecurity incidents, escalating certain cybersecurity incidents to the CISO according to protocol. The CISO is continually informed regarding the performance of the cybersecurity program, as well as the latest developments in cybersecurity, including potential threats and innovative risk management techniques aligned with industry standards. The CISO reports to our Chief Digital and Information Officer, who is a Senior Vice President of the Company and reports directly to our Chief Operating and Financial Officer (“COFO”). Our COFO is an Executive Vice President and an executive officer of the Company, and reports directly to our CEO.ITEM 2.PROPERTIESCorporate HeadquartersWe lease approximately 1.1 million square feet of office and laboratory space at our corporate headquarters in Boston, Massachusetts in two buildings pursuant to two leases that we entered into in May 2011 and amended in August 2024 to, among other terms, extend the lease termination dates from December 2028 to June 2044. We have the option to extend the term of the leases for up to two additional ten-year periods. Our cybersecurity program is integrated into our overall risk management systems, including our annual enterprise risk management program, internal audit program, business continuity and crisis management programs, third-party risk management program, insurance risk management program, and employee compliance programs. As part of our overall risk management program, we maintain a global insurance portfolio with comprehensive cyber coverage. Our Chief Information Security Officer (“CISO”) and the Information Security function advises, consults with, or provides input to each of these programs to ensure that material risks from cybersecurity threats are appropriately assessed, identified, and managed. As of the date of this report, there have been no cybersecurity threats that have materially affected or are reasonably likely to materially affect our business, operations, or financial condition. Similar to other companies, we have experienced cybersecurity incidents, including temporary service interruptions of third-party suppliers. As of the date of this report, however, known cybersecurity incidents, individually or in aggregate, have not had a material impact on our company. Over the last three years, net expenses incurred from any information security breaches, including any penalties and settlements, are not material relative to our total revenue. For additional discussion on cybersecurity risks we face, see Item 1.A, Risk Factors – “A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business.” of this Annual Report on Form 10-K Governance While our board of directors has oversight responsibility for risk management generally, the Audit and Finance While our board of directors has oversight responsibility for risk management generally, the Audit and Finance Committee (“Audit Committee”) is specifically responsible for overseeing our cybersecurity risk management program to ensure that cybersecurity risks are identified, assessed, managed, and monitored. Our CISO provides quarterly updates to the ensure that cybersecurity risks are identified, assessed, managed, and monitored. Our CISO provides quarterly updates to the Audit Committee in this regard, and covers the state of our cybersecurity program, supported by key performance indicators across the range of cybersecurity functions related to risk management and governance, identity and information asset protection, core security and endpoint security, and cyber threat operations. These updates include descriptions of protection, core security and endpoint security, and cyber threat operations. cybersecurity incidents of interest, including those associated with our third-party service providers; the board will be informed promptly of material risks from cybersecurity threats. We strive to create a culture of cybersecurity resilience and awareness and believe that cybersecurity is the responsibility of every employee and contractor. At the same time, primary responsibility for assessing, monitoring, and managing our A t the same time, primary responsibility for assessing, monitoring, and managing our cybersecurity risks lies with our CISO. Our CISO has more than 35 years of experience in security and information systems and spent 25 years with Raytheon Technologies, most recently as Chief Technology Officer of Cybersecurity, Special Missions, Training & Services. Our CISO supported the U.S. President's National Security Telecommunications Advisory Committee for more than 20 years, is a member of the Massachusetts Cybersecurity Strategy Council, and previously served as Chair of the Kogod Cybersecurity Governance Center at American University. He also served on the Rhode Island Homeland Security Advisory Board and was a member of various commercial cyber product councils. Our CISO oversees a team of skilled cybersecurity professionals who have Certified Information Systems Security Professional credentials, Global Information Assurance Certification from the SANS Institute, and other security and network certifications. The cybersecurity team monitors and evaluates our cybersecurity posture and performance on an ongoing basis, including through regular vulnerability scans, penetration tests, and threat intelligence feeds. The cybersecurity team uses various tools and methodologies to manage cybersecurity risk that are tested on a regular cadence, and assesses and evaluates cybersecurity incidents, escalating certain cybersecurity incidents to the CISO according to protocol. The CISO is continually informed regarding the performance of the cybersecurity program, as well as the latest developments in cybersecurity, including potential threats and innovative risk management techniques aligned with industry standards. The CISO reports to our Chief Digital and Information Officer, who is a Senior Vice President of the Company and reports directly to our Chief Operating and Financial Officer (“COFO”). Our COFO is an Executive Vice President and an executive officer of the Company, and reports directly to our CEO. ITEM 2.PROPERTIES Corporate Headquarters We lease approximately 1.1 million square feet of office and laboratory space at our corporate headquarters in Boston, Massachusetts in two buildings pursuant to two leases that we entered into in May 2011 and amended in August 2024 to, among other terms, extend the lease termination dates from December 2028 to June 2044. We have the option to extend the term of the leases for up to two additional ten-year periods. 41Additional United States and Worldwide LocationsIn addition to our corporate headquarters, we lease an aggregate of approximately 865,000 square feet of space globally. This space includes logistical, laboratory, commercial and manufacturing operations, as well as laboratory and office space to support our research and development organizations. We also own approximately 213,000 square feet at our continuous manufacturing facility in Massachusetts. Additionally, we are constructing the second building of our Leiden Campus in Massachusetts (“Leiden II”), which will include approximately 348,000 square feet of office and laboratory space. We expect Leiden II to be operational in late 2026.ITEM 3.LEGAL PROCEEDINGSOther than as described in Note P, “Commitments and Contingencies,” to our consolidated financial statements, we are not currently subject to any material legal proceedings.ITEM 4.MINE SAFETY DISCLOSURESNot applicable. 41 41 41 Additional United States and Worldwide LocationsIn addition to our corporate headquarters, we lease an aggregate of approximately 865,000 square feet of space globally. This space includes logistical, laboratory, commercial and manufacturing operations, as well as laboratory and office space to support our research and development organizations. We also own approximately 213,000 square feet at our continuous manufacturing facility in Massachusetts. Additionally, we are constructing the second building of our Leiden Campus in Massachusetts (“Leiden II”), which will include approximately 348,000 square feet of office and laboratory space. We expect Leiden II to be operational in late 2026.ITEM 3.LEGAL PROCEEDINGSOther than as described in Note P, “Commitments and Contingencies,” to our consolidated financial statements, we are not currently subject to any material legal proceedings.ITEM 4.MINE SAFETY DISCLOSURESNot applicable. Additional United States and Worldwide Locations In addition to our corporate headquarters, we lease an aggregate of approximately 865,000 square feet of space globally. This space includes logistical, laboratory, commercial and manufacturing operations, as well as laboratory and office space to support our research and development organizations. We also own approximately 213,000 square feet at our continuous manufacturing facility in Massachusetts. Additionally, we are constructing the second building of our Leiden Campus in Massachusetts (“Leiden II”), which will include approximately 348,000 square feet of office and laboratory space. We expect Leiden II to be operational in late 2026. ITEM 3.LEGAL PROCEEDINGS Other than as described in Note P, “Commitments and Contingencies,” to our consolidated financial statements, we are not currently subject to any material legal proceedings. ITEM 4.MINE SAFETY DISCLOSURES Not applicable. 42PART IIITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIESMarket InformationOur common stock is traded on The Nasdaq Global Select Market under the symbol “VRTX.” ShareholdersAs of February 6, 2026, there were 94 holders of record of our common stock.Performance Graph Our performance graph includes the NASDAQ Biotechnology Index, which we believe is a comparable index consisting of companies with similar industry classifications, and which we plan to use in our future performance graphs. 42 42 42 PART IIITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIESMarket InformationOur common stock is traded on The Nasdaq Global Select Market under the symbol “VRTX.” ShareholdersAs of February 6, 2026, there were 94 holders of record of our common stock.Performance Graph Our performance graph includes the NASDAQ Biotechnology Index, which we believe is a comparable index consisting of companies with similar industry classifications, and which we plan to use in our future performance graphs. PART II ITEM 5.MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND"
    },
    {
      "status": "ADDED",
      "current_title": "ISSUER PURCHASES OF EQUITY SECURITIES",
      "prior_title": null,
      "current_body": "Market Information Our common stock is traded on The Nasdaq Global Select Market under the symbol “VRTX.” Shareholders As of February 6, 2026, there were 94 holders of record of our common stock. Performance Graph Our performance graph includes the NASDAQ Biotechnology Index, which we believe is a comparable index consisting of companies with similar industry classifications, and which we plan to use in our future performance graphs. 43DividendsWe have never paid any cash dividends on our common stock, and we do not anticipate paying any in the foreseeable future.Issuer Repurchases of Equity SecuritiesIn May 2025, our Board of Directors approved a share repurchase program (our “2025 Share Repurchase Program”), pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock. The 2025 Share Repurchase Program does not have an expiration date and can be discontinued at any time. The table set forth below shows repurchases of securities by us during the three months ended December 31, 2025 under our 2025 Share Repurchase Program. PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Programs (1)Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (1)Oct. 1, 2025 to Oct. 31, 2025256,788$409.11256,788$3,381,462,793Nov. 1, 2025 to Nov. 30, 2025—$——$3,381,462,793Dec. 1, 2025 to Dec. 31, 2025—$——$3,381,462,793Total256,788$409.11256,788$3,381,462,793(1)Under our 2025 Share Repurchase Program, we are authorized to purchase shares from time to time through open market or privately negotiated transactions. Such purchases may be made pursuant to Rule 10b5-1 plans or other means as determined by our management and in accordance with the requirements of the Securities and Exchange Commission. ITEM 6.[RESERVED] 43 43 43 DividendsWe have never paid any cash dividends on our common stock, and we do not anticipate paying any in the foreseeable future.Issuer Repurchases of Equity SecuritiesIn May 2025, our Board of Directors approved a share repurchase program (our “2025 Share Repurchase Program”), pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock. The 2025 Share Repurchase Program does not have an expiration date and can be discontinued at any time. The table set forth below shows repurchases of securities by us during the three months ended December 31, 2025 under our 2025 Share Repurchase Program. PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Programs (1)Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (1)Oct. 1, 2025 to Oct. 31, 2025256,788$409.11256,788$3,381,462,793Nov. 1, 2025 to Nov. 30, 2025—$——$3,381,462,793Dec. 1, 2025 to Dec. 31, 2025—$——$3,381,462,793Total256,788$409.11256,788$3,381,462,793(1)Under our 2025 Share Repurchase Program, we are authorized to purchase shares from time to time through open market or privately negotiated transactions. Such purchases may be made pursuant to Rule 10b5-1 plans or other means as determined by our management and in accordance with the requirements of the Securities and Exchange Commission. ITEM 6.[RESERVED] Dividends We have never paid any cash dividends on our common stock, and we do not anticipate paying any in the foreseeable future."
    },
    {
      "status": "ADDED",
      "current_title": "Issuer Repurchases of Equity Securities",
      "prior_title": null,
      "current_body": "In May 2025, our Board of Directors approved a share repurchase program (our “2025 Share Repurchase Program”), pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock. The 2025 Share Repurchase Program does not have an expiration date and can be discontinued at any time. The table set forth below shows repurchases of securities by us during the three months ended December 31, 2025 under our 2025 Share Repurchase Program. PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Programs (1)Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (1)Oct. 1, 2025 to Oct. 31, 2025256,788$409.11256,788$3,381,462,793Nov. 1, 2025 to Nov. 30, 2025—$——$3,381,462,793Dec. 1, 2025 to Dec. 31, 2025—$——$3,381,462,793Total256,788$409.11256,788$3,381,462,793 PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Programs (1)Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (1)Oct. 1, 2025 to Oct. 31, 2025256,788$409.11256,788$3,381,462,793Nov. 1, 2025 to Nov. 30, 2025—$——$3,381,462,793Dec. 1, 2025 to Dec. 31, 2025—$——$3,381,462,793Total256,788$409.11256,788$3,381,462,793 PeriodTotal Number of Shares PurchasedAverage Price Paid per ShareTotal Number of Shares Purchased as Part of Publicly Announced Programs (1)Approximate Dollar Value of Shares that May Yet Be Purchased Under the Programs (1)Oct. 1, 2025 to Oct. 31, 2025256,788$409.11256,788$3,381,462,793Nov. 1, 2025 to Nov. 30, 2025—$——$3,381,462,793Dec. 1, 2025 to Dec. 31, 2025—$——$3,381,462,793Total256,788$409.11256,788$3,381,462,793 Period Period Period"
    },
    {
      "status": "ADDED",
      "current_title": "Programs (1)",
      "prior_title": null,
      "current_body": "Oct. 1, 2025 to Oct. 31, 2025 Oct. 1, 2025 to Oct. 31, 2025 Oct. 1, 2025 to Oct. 31, 2025 256,788 256,788 256,788 256,788 $409.11 $409.11 $409.11 $ 409.11 256,788 256,788 256,788 256,788 $3,381,462,793 $3,381,462,793 $3,381,462,793 $ 3,381,462,793 Nov. 1, 2025 to Nov. 30, 2025 Nov. 1, 2025 to Nov. 30, 2025 Nov. 1, 2025 to Nov. 30, 2025 — — — — $— $— $— $ — — — — — $3,381,462,793 $3,381,462,793 $3,381,462,793 $ 3,381,462,793 Dec. 1, 2025 to Dec. 31, 2025 Dec. 1, 2025 to Dec. 31, 2025 Dec. 1, 2025 to Dec. 31, 2025 — — — — $— $— $— $ — — — — — $3,381,462,793 $3,381,462,793 $3,381,462,793 $ 3,381,462,793 Total Total Total 256,788 256,788 256,788 256,788 $409.11 $409.11 $409.11 $ 409.11 256,788 256,788 256,788 256,788 $3,381,462,793 $3,381,462,793 $3,381,462,793 $ 3,381,462,793 (1)Under our 2025 Share Repurchase Program, we are authorized to purchase shares from time to time through open market or privately negotiated transactions. Such purchases may be made pursuant to Rule 10b5-1 plans or other means as determined by our management and in accordance with the requirements of the Securities and Exchange Commission. ITEM 6.[RESERVED] 44ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSOur discussion and analysis of our financial condition and results of operations for 2025 as compared to 2024 are discussed below. For a discussion of our financial condition and results of operations for 2024 as compared to 2023, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K, except as set forth below.OVERVIEWWe are a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”), sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1.Collectively, our five CF medicines, led by TRIKAFTA/KAFTRIO, are being used to treat nearly three quarters of the people with CF in the U.S., Europe, Australia, and Canada. ALYFTREK, our newest CF medicine, is approved in the United States (the “U.S.”), the United Kingdom (the “U.K.”), the European Union (the “E.U.”), Canada, New Zealand, Switzerland, Australia and Israel. CASGEVY, our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the E.U., the U.K., the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), Qatar, the United Arab Emirates (the “UAE”), Kuwait, Switzerland and Canada for the treatment of people 12 years of age and older with SCD or TDT. JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, is approved in the U.S. for the treatment of people with moderate-to-severe acute pain. We are continuing our commercial launch of JOURNAVX for eligible adults. Financial HighlightsTotal RevenuesIn 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY.Cost of SalesOur cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements.Total R&D and SG&A ExpensesOur total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline.AIPR&D ExpensesIn 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition.CashOur total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock.$0.1 44 44 44 ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONSOur discussion and analysis of our financial condition and results of operations for 2025 as compared to 2024 are discussed below. For a discussion of our financial condition and results of operations for 2024 as compared to 2023, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K, except as set forth below.OVERVIEWWe are a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”), sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1.Collectively, our five CF medicines, led by TRIKAFTA/KAFTRIO, are being used to treat nearly three quarters of the people with CF in the U.S., Europe, Australia, and Canada. ALYFTREK, our newest CF medicine, is approved in the United States (the “U.S.”), the United Kingdom (the “U.K.”), the European Union (the “E.U.”), Canada, New Zealand, Switzerland, Australia and Israel. CASGEVY, our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the E.U., the U.K., the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), Qatar, the United Arab Emirates (the “UAE”), Kuwait, Switzerland and Canada for the treatment of people 12 years of age and older with SCD or TDT. JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, is approved in the U.S. for the treatment of people with moderate-to-severe acute pain. We are continuing our commercial launch of JOURNAVX for eligible adults. Financial HighlightsTotal RevenuesIn 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY.Cost of SalesOur cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements.Total R&D and SG&A ExpensesOur total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline.AIPR&D ExpensesIn 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition.CashOur total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock.$0.1 ITEM 7.MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS Our discussion and analysis of our financial condition and results of operations for 2025 as compared to 2024 are discussed below. For a discussion of our financial condition and results of operations for 2024 as compared to 2023, please refer to Item 7, “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in our 2024 Annual Report on Form 10-K, except as set forth below. OVERVIEW We are a global biotechnology company that invests in scientific innovation to create transformative medicines for medicines people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”), sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline includes programs across a range of modalities in additional serious diseases, including IgA nephropathy, APOL1-mediated kidney disease, neuropathic pain, type 1 diabetes, primary membranous nephropathy, autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1. Collectively, our five CF medicines, led by TRIKAFTA/KAFTRIO, are being used to treat nearly three quarters of the people with CF in the U.S., Europe, Australia, and Canada. ALYFTREK, our newest CF medicine, is approved in the United States (the “U.S.”), the United Kingdom (the “U.K.”), the European Union (the “E.U.”), Canada, New Zealand, Switzerland, Australia and Israel. CASGEVY, our ex-vivo, non-viral CRISPR/Cas9 gene-edited cell therapy, is approved in the U.S., the E.U., the U.K., the Kingdom of Saudi Arabia (“Saudi Arabia”), the Kingdom of Bahrain (“Bahrain”), Qatar, the United Arab Emirates (the “UAE”), Kuwait, Switzerland and Canada for the treatment of people 12 years of age and older with SCD or TDT. JOURNAVX, our selective non-opioid NaV1.8 pain signal inhibitor, is approved in the U.S. for the treatment of people with moderate-to-severe acute pain. We are continuing our commercial launch of JOURNAVX for eligible adults."
    },
    {
      "status": "ADDED",
      "current_title": "Financial Highlights",
      "prior_title": null,
      "current_body": "Total RevenuesIn 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY.Cost of SalesOur cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements.Total R&D and SG&A ExpensesOur total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline.AIPR&D ExpensesIn 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition.CashOur total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. Total RevenuesIn 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY.Cost of SalesOur cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements.Total R&D and SG&A ExpensesOur total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline.AIPR&D ExpensesIn 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition.CashOur total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. Total RevenuesIn 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY.Cost of SalesOur cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements.Total R&D and SG&A ExpensesOur total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline.AIPR&D ExpensesIn 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition.CashOur total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. Total Revenues Total Revenues Total Revenues In 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY. In 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY. In 2025, our total revenues increased to $12.0 billion as compared to $11.0 billion in 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY. Cost of Sales Cost of Sales Cost of Sales Our cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements. Our cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements. Our cost of sales as a percentage of our net product revenues decreased from 13.9% in 2024 to 13.8% in 2025 as a result of a lower overall royalty rate for our CF medicines, partially offset by changes in our product mix, and investments in network expansion and manufacturing process improvements. Total R&D and SG&A Expenses Total R&D and SG&A Expenses Total R&D and SG&A Expenses Our total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline. Our total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline. Our total research and development (“R&D”) and selling, general and administrative (“SG&A”) expenses increased to $5.7 billion in 2025 as compared to $5.1 billion in 2024, primarily due to increased investment to commercialize our new products and to advance our R&D pipeline. AIPR&D Expenses AIPR&D Expenses AIPR&D Expenses In 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition. In 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in-licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition. In 2025, our acquired in-process research and development expenses (“AIPR&D”) of $133.0 million included various upfront and milestone payments related to our collaboration and in- licensing arrangements. In 2024, AIPR&D included $4.4 billion resulting from our acquisition of Alpine Immune Sciences, Inc. (“Alpine”), which was accounted for as an asset acquisition. Cash Cash Cash Our total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. Our total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. Our total cash, cash equivalents and marketable securities increased to $12.3 billion as of December 31, 2025 as compared to $11.2 billion as of December 31, 2024 primarily due to cash flows provided by our operating activities partially offset by repurchases of our common stock. $0.1 $0.1 $0.1 $0.1 $0.1 45$0.120242025December 31, 2025December 31, 2024Note: Charts above may not add due to rounding.Business Updates Marketed ProductsCystic FibrosisWe expect that the number of people with CF taking our medicines will continue to grow through new approvals and reimbursement agreements, treatment of younger patients, increased survival and expansion into additional geographies. •ALYFTREK is reimbursed for eligible people with CF in the U.S., England, Ireland, Germany, Denmark, Northern Ireland, Norway, Wales, Italy, Australia, New Zealand and Luxembourg. We are working to secure access for eligible patients in additional countries.Sickle Cell Disease and Beta Thalassemia•In 2025, we recorded $115.8 million of CASGEVY product revenues. This reflects 64 patients receiving infusions of CASGEVY in 2025, including 30 people infused in the fourth quarter. Globally, in 2025, 147 people with SCD or TDT had their first cell collection for CASGEVY. •As of the end of 2025, approximately 90 percent of people with SCD or TDT in the U.S. have reimbursed access to CASGEVY, which is also reimbursed in the U.K., Italy, Austria, Denmark, Luxembourg, Saudi Arabia, the UAE, Bahrain, and Kuwait. In January 2026, we secured reimbursed access to CASGEVY for eligible people with SCD in Scotland, consistent with the reimbursement agreement reached in 2025 for people with TDT. •We expect to begin global regulatory submissions for approvals for CASGEVY in children 5 to 11 years of age, in the first half of 2026. The FDA awarded Vertex with a Commissioner’s National Priority Voucher for this pediatric submission, indicating an accelerated timeline for review once the submission is complete.Acute Pain•Since pharmacy availability in March 2025 through year-end 2025, more than 550,000 prescriptions for JOURNAVX were written and filled across the hospital and retail settings in different acute pain conditions, consistent with JOURNAVX’s broad label. •We have secured access for JOURNAVX with all three national pharmacy benefit managers, and, as of January 2026, over 200 million individuals across commercial and government payers have coverage, representing two-thirds of U.S. covered lives. In addition, 21 states provide coverage via Medicaid. •More than 100 of the targeted 150 healthcare systems and more than 950 individual hospitals of the 2,000 targeted institutions have added JOURNAVX to formularies, protocols or order sets. 45 45 45 $0.120242025December 31, 2025December 31, 2024Note: Charts above may not add due to rounding.Business Updates Marketed ProductsCystic FibrosisWe expect that the number of people with CF taking our medicines will continue to grow through new approvals and reimbursement agreements, treatment of younger patients, increased survival and expansion into additional geographies. •ALYFTREK is reimbursed for eligible people with CF in the U.S., England, Ireland, Germany, Denmark, Northern Ireland, Norway, Wales, Italy, Australia, New Zealand and Luxembourg. We are working to secure access for eligible patients in additional countries.Sickle Cell Disease and Beta Thalassemia•In 2025, we recorded $115.8 million of CASGEVY product revenues. This reflects 64 patients receiving infusions of CASGEVY in 2025, including 30 people infused in the fourth quarter. Globally, in 2025, 147 people with SCD or TDT had their first cell collection for CASGEVY. •As of the end of 2025, approximately 90 percent of people with SCD or TDT in the U.S. have reimbursed access to CASGEVY, which is also reimbursed in the U.K., Italy, Austria, Denmark, Luxembourg, Saudi Arabia, the UAE, Bahrain, and Kuwait. In January 2026, we secured reimbursed access to CASGEVY for eligible people with SCD in Scotland, consistent with the reimbursement agreement reached in 2025 for people with TDT. •We expect to begin global regulatory submissions for approvals for CASGEVY in children 5 to 11 years of age, in the first half of 2026. The FDA awarded Vertex with a Commissioner’s National Priority Voucher for this pediatric submission, indicating an accelerated timeline for review once the submission is complete.Acute Pain•Since pharmacy availability in March 2025 through year-end 2025, more than 550,000 prescriptions for JOURNAVX were written and filled across the hospital and retail settings in different acute pain conditions, consistent with JOURNAVX’s broad label. •We have secured access for JOURNAVX with all three national pharmacy benefit managers, and, as of January 2026, over 200 million individuals across commercial and government payers have coverage, representing two-thirds of U.S. covered lives. In addition, 21 states provide coverage via Medicaid. •More than 100 of the targeted 150 healthcare systems and more than 950 individual hospitals of the 2,000 targeted institutions have added JOURNAVX to formularies, protocols or order sets. $0.1 $0.1 $0.1 $0.1 $0.1 2024 2024 2024 2024 2024 2025 2025 2025 2025 2025 December 31, 2025 December 31, 2025 December 31, 2025 December 31, 2025 December 31, 2025 December 31, 2024 December 31, 2024 December 31, 2024 December 31, 2024 December 31, 2024 Note: Charts above may not add due to rounding."
    },
    {
      "status": "ADDED",
      "current_title": "Business Updates",
      "prior_title": null,
      "current_body": "Marketed Products Cystic Fibrosis We expect that the number of people with CF taking our medicines will continue to grow through new approvals and reimbursement agreements, treatment of younger patients, increased survival and expansion into additional geographies. •ALYFTREK is reimbursed for eligible people with CF in the U.S., England, Ireland, Germany, Denmark, Northern Ireland, Norway, Wales, Italy, Australia, New Zealand and Luxembourg. We are working to secure access for eligible patients in additional countries. Sickle Cell Disease and Beta Thalassemia •In 2025, we recorded $115.8 million of CASGEVY product revenues. This reflects 64 patients receiving infusions of CASGEVY in 2025, including 30 people infused in the fourth quarter. Globally, in 2025, 147 people with SCD or TDT had their first cell collection for CASGEVY. •As of the end of 2025, approximately 90 percent of people with SCD or TDT in the U.S. have reimbursed access to CASGEVY, which is also reimbursed in the U.K., Italy, Austria, Denmark, Luxembourg, Saudi Arabia, the UAE, Bahrain, and Kuwait. In January 2026, we secured reimbursed access to CASGEVY for eligible people with SCD in Scotland, consistent with the reimbursement agreement reached in 2025 for people with TDT. •We expect to begin global regulatory submissions for approvals for CASGEVY in children 5 to 11 years of age, in the first half of 2026. The FDA awarded Vertex with a Commissioner’s National Priority Voucher for this pediatric submission, indicating an accelerated timeline for review once the submission is complete. Acute Pain •Since pharmacy availability in March 2025 through year-end 2025, more than 550,000 prescriptions for JOURNAVX were written and filled across the hospital and retail settings in different acute pain conditions, consistent with JOURNAVX’s broad label. •We have secured access for JOURNAVX with all three national pharmacy benefit managers, and, as of January 2026, over 200 million individuals across commercial and government payers have coverage, representing two- thirds of U.S. covered lives. In addition, 21 states provide coverage via Medicaid. •More than 100 of the targeted 150 healthcare systems and more than 950 individual hospitals of the 2,000 targeted institutions have added JOURNAVX to formularies, protocols or order sets. 46Select R&D Pipeline ProgramsWe continue to advance a diversified pipeline of potentially transformative medicines for serious diseases utilizing a range of modalities. Recent and anticipated progress in activities supporting these efforts is included below: Cystic Fibrosis•We completed the global trial evaluating ALYFTREK in children 2 to 5 years of age. Following positive results from this clinical trial, we expect to submit for approval with global regulators in this age group in the first half of 2026. We also initiated a pivotal trial of ALYFTREK in children 1 year to less than 2 years of age.•Following positive results from the clinical trial evaluating TRIKAFTA in children 1 year to less than 2 years of age, we expect to begin submissions for global regulatory approvals in this age group in the first half of 2026.IgA Nephropathy•We are developing povetacicept, a dual inhibitor of B cell activating factor (“BAFF”) and a proliferation-inducing ligand (“APRIL”) cytokines, for multiple diseases. Povetacicept represents a potentially best-in-class approach to control B cell activity in immunoglobulin A nephropathy (“IgAN”).•We completed enrollment in the Phase 3 clinical trial evaluating povetacicept for IgAN and, in the fourth quarter of 2025, we initiated the rolling Biologics Licensing Application (“BLA”) filing for U.S. accelerated approval with submission of the first module. We expect to release interim analysis data in the first half of 2026 and we expect to complete the submission in the first half of 2026, if data from the interim analysis are supportive. We are using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months.APOL1-Mediated Kidney Disease•Inaxaplin is our small molecule for the treatment of APOL1-mediated kidney disease (“AMKD”). We completed enrollment in the interim analysis cohort of the global Phase 2/3 pivotal clinical trial evaluating inaxaplin in people with primary AMKD (“AMPLITUDE”). We expect to conduct the pre-planned interim analysis once this cohort has been treated for 48 weeks and we expect to share data from the interim analysis in late 2026 or early 2027. We expect to complete full enrollment in AMPLITUDE in the second half of 2026.Peripheral Neuropathic Pain•We previously initiated the first Phase 3 clinical trial evaluating suzetrigine for the treatment of people with diabetic peripheral neuropathy (“DPN”), a common form of peripheral neuropathic pain, and have initiated a second Phase 3 clinical trial evaluating suzetrigine in DPN in the fourth quarter of 2025. We expect to complete enrollment in both Phase 3 clinical trials by the end of 2026.Type 1 Diabetes•Zimislecel is an allogeneic, stem cell-derived, fully differentiated, insulin-producing islet cell replacement therapy, using standard immunosuppression to protect the implanted cells. We have completed enrollment in the Phase 1/2/3 clinical trial of zimislecel in people with type 1 diabetes (“T1D”). We have temporarily postponed completion of dosing in this clinical trial, pending an internal manufacturing analysis.Primary Membranous Nephropathy•Povetacicept represents a potentially best-in-class approach to control B cell activity in primary membranous nephropathy (“pMN”), another B cell-mediated disease. We are enrolling and dosing patients in the adaptive Phase 2/3 pivotal clinical trial of povetacicept for the treatment of people with pMN. We expect to complete the Phase 2 portion of the clinical trial and to initiate the Phase 3 portion in mid-2026. 46 46 46 Select R&D Pipeline ProgramsWe continue to advance a diversified pipeline of potentially transformative medicines for serious diseases utilizing a range of modalities. Recent and anticipated progress in activities supporting these efforts is included below: Cystic Fibrosis•We completed the global trial evaluating ALYFTREK in children 2 to 5 years of age. Following positive results from this clinical trial, we expect to submit for approval with global regulators in this age group in the first half of 2026. We also initiated a pivotal trial of ALYFTREK in children 1 year to less than 2 years of age.•Following positive results from the clinical trial evaluating TRIKAFTA in children 1 year to less than 2 years of age, we expect to begin submissions for global regulatory approvals in this age group in the first half of 2026.IgA Nephropathy•We are developing povetacicept, a dual inhibitor of B cell activating factor (“BAFF”) and a proliferation-inducing ligand (“APRIL”) cytokines, for multiple diseases. Povetacicept represents a potentially best-in-class approach to control B cell activity in immunoglobulin A nephropathy (“IgAN”).•We completed enrollment in the Phase 3 clinical trial evaluating povetacicept for IgAN and, in the fourth quarter of 2025, we initiated the rolling Biologics Licensing Application (“BLA”) filing for U.S. accelerated approval with submission of the first module. We expect to release interim analysis data in the first half of 2026 and we expect to complete the submission in the first half of 2026, if data from the interim analysis are supportive. We are using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months.APOL1-Mediated Kidney Disease•Inaxaplin is our small molecule for the treatment of APOL1-mediated kidney disease (“AMKD”). We completed enrollment in the interim analysis cohort of the global Phase 2/3 pivotal clinical trial evaluating inaxaplin in people with primary AMKD (“AMPLITUDE”). We expect to conduct the pre-planned interim analysis once this cohort has been treated for 48 weeks and we expect to share data from the interim analysis in late 2026 or early 2027. We expect to complete full enrollment in AMPLITUDE in the second half of 2026.Peripheral Neuropathic Pain•We previously initiated the first Phase 3 clinical trial evaluating suzetrigine for the treatment of people with diabetic peripheral neuropathy (“DPN”), a common form of peripheral neuropathic pain, and have initiated a second Phase 3 clinical trial evaluating suzetrigine in DPN in the fourth quarter of 2025. We expect to complete enrollment in both Phase 3 clinical trials by the end of 2026.Type 1 Diabetes•Zimislecel is an allogeneic, stem cell-derived, fully differentiated, insulin-producing islet cell replacement therapy, using standard immunosuppression to protect the implanted cells. We have completed enrollment in the Phase 1/2/3 clinical trial of zimislecel in people with type 1 diabetes (“T1D”). We have temporarily postponed completion of dosing in this clinical trial, pending an internal manufacturing analysis.Primary Membranous Nephropathy•Povetacicept represents a potentially best-in-class approach to control B cell activity in primary membranous nephropathy (“pMN”), another B cell-mediated disease. We are enrolling and dosing patients in the adaptive Phase 2/3 pivotal clinical trial of povetacicept for the treatment of people with pMN. We expect to complete the Phase 2 portion of the clinical trial and to initiate the Phase 3 portion in mid-2026. Select R&D Pipeline Programs We continue to advance a diversified pipeline of potentially transformative medicines for serious diseases utilizing a range of modalities. Recent and anticipated progress in activities supporting these efforts is included below: Cystic Fibrosis •We completed the global trial evaluating ALYFTREK in children 2 to 5 years of age. Following positive results from this clinical trial, we expect to submit for approval with global regulators in this age group in the first half of 2026. We also initiated a pivotal trial of ALYFTREK in children 1 year to less than 2 years of age. •Following positive results from the clinical trial evaluating TRIKAFTA in children 1 year to less than 2 years of age, we expect to begin submissions for global regulatory approvals in this age group in the first half of 2026. IgA Nephropathy •We are developing povetacicept, a dual inhibitor of B cell activating factor (“BAFF”) and a proliferation-inducing ligand (“APRIL”) cytokines, for multiple diseases. Povetacicept represents a potentially best-in-class approach to control B cell activity in immunoglobulin A nephropathy (“IgAN”). •We completed enrollment in the Phase 3 clinical trial evaluating povetacicept for IgAN and, in the fourth quarter of 2025, we initiated the rolling Biologics Licensing Application (“BLA”) filing for U.S. accelerated approval with submission of the first module. We expect to release interim analysis data in the first half of 2026 and we expect to complete the submission in the first half of 2026, if data from the interim analysis are supportive. We are using a We are using a priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. priority review voucher to expedite the review of the povetacicept BLA from ten months to six months. APOL1-Mediated Kidney Disease •Inaxaplin is our small molecule for the treatment of APOL1-mediated kidney disease (“AMKD”). We completed enrollment in the interim analysis cohort of the global Phase 2/3 pivotal clinical trial evaluating inaxaplin in people with primary AMKD (“AMPLITUDE”). We expect to conduct the pre-planned interim analysis once this cohort has been treated for 48 weeks and we expect to share data from the interim analysis in late 2026 or early 2027. We expect to complete full enrollment in AMPLITUDE in the second half of 2026. Peripheral Neuropathic Pain •We previously initiated the first Phase 3 clinical trial evaluating suzetrigine for the treatment of people with diabetic peripheral neuropathy (“DPN”), a common form of peripheral neuropathic pain, and have initiated a second Phase 3 clinical trial evaluating suzetrigine in DPN in the fourth quarter of 2025. We expect to complete enrollment in both Phase 3 clinical trials by the end of 2026. Type 1 Diabetes •Zimislecel is an allogeneic, stem cell-derived, fully differentiated, insulin-producing islet cell replacement therapy, using standard immunosuppression to protect the implanted cells. We have completed enrollment in the Phase 1/2/3 clinical trial of zimislecel in people with type 1 diabetes (“T1D”). We have temporarily postponed completion of dosing in this clinical trial, pending an internal manufacturing analysis. Primary Membranous Nephropathy Primary Membranous Nephropathy •Povetacicept represents a potentially best-in-class approach to control B cell activity in primary membranous nephropathy (“pMN”), another B cell-mediated disease. We are enrolling and dosing patients in the adaptive Phase 2/3 pivotal clinical trial of povetacicept for the treatment of people with pMN. We expect to complete the Phase 2 portion of the clinical trial and to initiate the Phase 3 portion in mid-2026. 47External InnovationRecent investments in external innovation include:•An exclusive global license agreement with WuXi Biologics to develop and commercialize a trispecific T cell engager for B cell-mediated autoimmune diseases, which is currently in preclinical development. Our Business EnvironmentIn 2025, our net product revenues were primarily from the sale of our medicines for the treatment of CF. Our CF strategy involves continuing to develop and obtain approval and reimbursement for treatment regimens that will provide benefits to all people with CF and increasing the number of people with CF eligible and able to receive our medicines. Outside of CF, we continue to advance the commercialization of CASGEVY for the treatment of SCD and TDT, and JOURNAVX for the treatment of acute pain. In addition, we are advancing our pipeline of product candidates for the treatment of serious diseases outside of CF, SCD, TDT and acute pain.Our strategy is to combine transformative advances in the understanding of causal human biology and the science of therapeutics to discover and develop innovative medicines. This approach includes advancing multiple compounds or therapies from each program, spanning multiple modalities, into early clinical trials to obtain patient data that can inform selection of the most promising therapies for later-stage development, as well as to inform discovery and development efforts. We aim to serially innovate in our disease areas of interest and follow our first-in-class therapies with potential best-in-class candidates to provide durable clinical and commercial success.In pursuit of new product candidates and therapies in specialty markets, we invest in research and development. We believe that pursuing research in diverse areas allows us to balance the risks inherent in product development and may provide product candidates that will form our pipeline in future years. To supplement our internal research programs, we acquire technologies and programs and collaborate with biopharmaceutical and technology companies, leading academic research institutions, government laboratories, foundations and other organizations, as needed, to advance research in our areas of therapeutic interest and to access technologies needed to execute on our strategy.Discovery and development of a new pharmaceutical or biological product is a difficult and lengthy process that requires significant financial resources along with extensive technical and regulatory expertise. Across the industry, most potential drug or biological products never progress into development, and most products that advance into development never receive marketing approval. Our investments in product candidates are subject to considerable risks. We closely monitor our research and development activities, and frequently evaluate our pipeline programs in light of new data and scientific, business and commercial insights, with the objective of balancing risk and potential. This process can result in rapid changes in focus and priorities as new information becomes available and as we gain additional understanding of our ongoing programs and potential new programs, as well as those of our competitors. In addition, our product candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale by regulatory authorities. Our analysis of data obtained from nonclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.Our business also requires ensuring appropriate manufacturing and supply of our products. As we advance our product candidates through clinical development toward commercialization and market and sell our approved products, we build and maintain our supply chain and quality assurance resources. We rely on a global network of third parties, including some in China, and our internal capabilities to manufacture and distribute our products for commercial sale and post-approval clinical trials and to manufacture and distribute our product candidates for clinical trials. In addition to establishing supply chains for each newly approved product, we adapt our supply chain for existing products to include additional formulations or to increase scale of production for existing products as needed. The processes for biological and cell and genetic therapies can be more complex than those required for small molecule drugs and require additional investments in different systems, equipment, facilities and expertise. We are focused on ensuring the stability of the supply chains for our current products, as well as for our pipeline programs. Sales of our products depend, to a large degree, on the extent to which our products are reimbursed by third-party payors, such as government health programs, commercial insurance and managed health care organizations. Reimbursement for our products, including our potential pipeline therapies, cannot be assured and may take significant periods of time to obtain. We dedicate substantial management and other resources to obtain and maintain appropriate levels of reimbursement for our 47 47 47 External InnovationRecent investments in external innovation include:•An exclusive global license agreement with WuXi Biologics to develop and commercialize a trispecific T cell engager for B cell-mediated autoimmune diseases, which is currently in preclinical development. Our Business EnvironmentIn 2025, our net product revenues were primarily from the sale of our medicines for the treatment of CF. Our CF strategy involves continuing to develop and obtain approval and reimbursement for treatment regimens that will provide benefits to all people with CF and increasing the number of people with CF eligible and able to receive our medicines. Outside of CF, we continue to advance the commercialization of CASGEVY for the treatment of SCD and TDT, and JOURNAVX for the treatment of acute pain. In addition, we are advancing our pipeline of product candidates for the treatment of serious diseases outside of CF, SCD, TDT and acute pain.Our strategy is to combine transformative advances in the understanding of causal human biology and the science of therapeutics to discover and develop innovative medicines. This approach includes advancing multiple compounds or therapies from each program, spanning multiple modalities, into early clinical trials to obtain patient data that can inform selection of the most promising therapies for later-stage development, as well as to inform discovery and development efforts. We aim to serially innovate in our disease areas of interest and follow our first-in-class therapies with potential best-in-class candidates to provide durable clinical and commercial success.In pursuit of new product candidates and therapies in specialty markets, we invest in research and development. We believe that pursuing research in diverse areas allows us to balance the risks inherent in product development and may provide product candidates that will form our pipeline in future years. To supplement our internal research programs, we acquire technologies and programs and collaborate with biopharmaceutical and technology companies, leading academic research institutions, government laboratories, foundations and other organizations, as needed, to advance research in our areas of therapeutic interest and to access technologies needed to execute on our strategy.Discovery and development of a new pharmaceutical or biological product is a difficult and lengthy process that requires significant financial resources along with extensive technical and regulatory expertise. Across the industry, most potential drug or biological products never progress into development, and most products that advance into development never receive marketing approval. Our investments in product candidates are subject to considerable risks. We closely monitor our research and development activities, and frequently evaluate our pipeline programs in light of new data and scientific, business and commercial insights, with the objective of balancing risk and potential. This process can result in rapid changes in focus and priorities as new information becomes available and as we gain additional understanding of our ongoing programs and potential new programs, as well as those of our competitors. In addition, our product candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale by regulatory authorities. Our analysis of data obtained from nonclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval.Our business also requires ensuring appropriate manufacturing and supply of our products. As we advance our product candidates through clinical development toward commercialization and market and sell our approved products, we build and maintain our supply chain and quality assurance resources. We rely on a global network of third parties, including some in China, and our internal capabilities to manufacture and distribute our products for commercial sale and post-approval clinical trials and to manufacture and distribute our product candidates for clinical trials. In addition to establishing supply chains for each newly approved product, we adapt our supply chain for existing products to include additional formulations or to increase scale of production for existing products as needed. The processes for biological and cell and genetic therapies can be more complex than those required for small molecule drugs and require additional investments in different systems, equipment, facilities and expertise. We are focused on ensuring the stability of the supply chains for our current products, as well as for our pipeline programs. Sales of our products depend, to a large degree, on the extent to which our products are reimbursed by third-party payors, such as government health programs, commercial insurance and managed health care organizations. Reimbursement for our products, including our potential pipeline therapies, cannot be assured and may take significant periods of time to obtain. We dedicate substantial management and other resources to obtain and maintain appropriate levels of reimbursement for our External Innovation Recent investments in external innovation include: •An exclusive global license agreement with WuXi Biologics to develop and commercialize a trispecific T cell engager for B cell-mediated autoimmune diseases, which is currently in preclinical development."
    },
    {
      "status": "ADDED",
      "current_title": "Our Business Environment",
      "prior_title": null,
      "current_body": "In 2025, our net product revenues were primarily from the sale of our medicines for the treatment of CF. Our CF strategy involves continuing to develop and obtain approval and reimbursement for treatment regimens that will provide benefits to all people with CF and increasing the number of people with CF eligible and able to receive our medicines. Outside of CF, we continue to advance the commercialization of CASGEVY for the treatment of SCD and TDT, and JOURNAVX for the treatment of acute pain. In addition, we are advancing our pipeline of product candidates for the treatment of serious diseases outside of CF, SCD, TDT and acute pain. Our strategy is to combine transformative advances in the understanding of causal human biology and the science of therapeutics to discover and develop innovative medicines. This approach includes advancing multiple compounds or therapies from each program, spanning multiple modalities, into early clinical trials to obtain patient data that can inform selection of the most promising therapies for later-stage development, as well as to inform discovery and development efforts. We aim to serially innovate in our disease areas of interest and follow our first-in-class therapies with potential best- in-class candidates to provide durable clinical and commercial success. In pursuit of new product candidates and therapies in specialty markets, we invest in research and development. We believe that pursuing research in diverse areas allows us to balance the risks inherent in product development and may provide product candidates that will form our pipeline in future years. To supplement our internal research programs, we acquire technologies and programs and collaborate with biopharmaceutical and technology companies, leading academic research institutions, government laboratories, foundations and other organizations, as needed, to advance research in our areas of therapeutic interest and to access technologies needed to execute on our strategy. Discovery and development of a new pharmaceutical or biological product is a difficult and lengthy process that requires significant financial resources along with extensive technical and regulatory expertise. Across the industry, most potential drug or biological products never progress into development, and most products that advance into development never receive marketing approval. Our investments in product candidates are subject to considerable risks. We closely monitor our research and development activities, and frequently evaluate our pipeline programs in light of new data and scientific, business and commercial insights, with the objective of balancing risk and potential. This process can result in rapid changes in focus and priorities as new information becomes available and as we gain additional understanding of our ongoing programs and potential new programs, as well as those of our competitors. In addition, our product candidates must satisfy rigorous standards of safety and efficacy before they can be approved for sale by regulatory authorities. Our analysis of data obtained from nonclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. Our business also requires ensuring appropriate manufacturing and supply of our products. As we advance our product candidates through clinical development toward commercialization and market and sell our approved products, we build and maintain our supply chain and quality assurance resources. We rely on a global network of third parties, including some in China, and our internal capabilities to manufacture and distribute our products for commercial sale and post-approval clinical trials and to manufacture and distribute our product candidates for clinical trials. In addition to establishing supply chains for each newly approved product, we adapt our supply chain for existing products to include additional formulations or to increase scale of production for existing products as needed. The processes for biological and cell and genetic therapies can be more complex than those required for small molecule drugs and require additional investments in different systems, equipment, facilities and expertise. We are focused on ensuring the stability of the supply chains for our current products, as well as for our pipeline programs. Sales of our products depend, to a large degree, on the extent to which our products are reimbursed by third-party payors, such as government health programs, commercial insurance and managed health care organizations. Reimbursement for our products, including our potential pipeline therapies, cannot be assured and may take significant periods of time to obtain. We dedicate substantial management and other resources to obtain and maintain appropriate levels of reimbursement for our 48products from third-party payors, including governmental organizations in the U.S. and ex-U.S. markets. In the U.S., we work with government and commercial payors to obtain and maintain appropriate levels of reimbursement for our medicines. In ex-U.S. markets, we seek government reimbursement for our medicines on a country-by-country or region-by-region, as required. This is necessary for each new medicine, as well as for label expansions for our current medicines. We expect to continue to focus significant resources to expand and maintain reimbursement for our CF medicines, CASGEVY, JOURNAVX, and, ultimately, our pipeline therapies, in U.S. and ex-U.S. markets. Strategic TransactionsAcquisitionsAs part of our business strategy, we seek to acquire technologies, products, product candidates and other businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts. We have acquired multiple biotechnology companies over the last several years and expect to continue to identify and evaluate such opportunities. The accounting for these acquisitions can vary significantly based on whether we conclude the transactions represent business combinations or asset acquisitions. In 2024, we acquired Alpine and its lead molecule, povetacicept, for approximately $5.0 billion. Povetacicept has shown potential to treat multiple diseases or conditions and become a pipeline-in-a-product. We accounted for the Alpine transaction as an asset acquisition because povetacicept represented substantially all of the fair value of the gross assets that we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed as AIPR&D in 2024. In 2019 and 2022, we acquired Semma Therapeutics, Inc. (“Semma”) and ViaCyte, Inc. (“ViaCyte”), respectively, pursuant to which we established and accelerated the development of our T1D program. We accounted for each of these acquisitions as a business combination.Please refer to our critical accounting policies, “Acquisitions,” for further information regarding the significant judgments and estimates related to our acquisitions.Collaboration and In-Licensing ArrangementsWe enter into arrangements with third parties, including collaboration and licensing arrangements, for the development, manufacture and commercialization of products, product candidates, and other technologies that have the potential to complement our ongoing research and development efforts.Over the last several years, we entered into collaboration agreements with a number of companies, including CRISPR Therapeutics AG (“CRISPR”), Entrada Therapeutics, Inc. (“Entrada”), and Moderna, Inc. Generally, when we in-license a technology or product candidate, we make upfront payments to the collaborator, assume the costs of the program and/or agree to make contingent payments, which could consist of milestone, royalty and option payments. Most of these collaboration payments are expensed as AIPR&D, including, a $75.0 million milestone paid to Entrada in 2024, and, in 2023, total payments of $242.6 million to Entrada and total upfront and milestone payments of $170.0 million to CRISPR related to T1D. These payments were expensed to AIPR&D because they were primarily attributable to acquired in-process research and development for which there was no alternative future use. However, depending on many factors, including the structure of the collaboration, the stage of development of the acquired technology, the significance of the in-licensed product candidate to the collaborator’s operations and the other activities in which our collaborators are engaged, the accounting for these transactions can vary significantly. We expect to continue to identify and evaluate collaboration and licensing opportunities that may be similar to or different from the collaborations and licenses that we have engaged in previously.Joint Development and Commercialization Agreement with CRISPRIn 2017, we entered into a joint development and commercialization agreement with CRISPR (the “CRISPR JDCA”), which we amended and restated in 2021.Pursuant to the CRISPR JDCA, we lead global development, manufacturing and commercialization of CASGEVY, with support from CRISPR. We also conduct all research, development, manufacturing and commercialization activities relating to other product candidates and products under the CRISPR JDCA throughout the world subject to CRISPR’s reserved right to conduct certain activities. 48 48 48 products from third-party payors, including governmental organizations in the U.S. and ex-U.S. markets. In the U.S., we work with government and commercial payors to obtain and maintain appropriate levels of reimbursement for our medicines. In ex-U.S. markets, we seek government reimbursement for our medicines on a country-by-country or region-by-region, as required. This is necessary for each new medicine, as well as for label expansions for our current medicines. We expect to continue to focus significant resources to expand and maintain reimbursement for our CF medicines, CASGEVY, JOURNAVX, and, ultimately, our pipeline therapies, in U.S. and ex-U.S. markets. Strategic TransactionsAcquisitionsAs part of our business strategy, we seek to acquire technologies, products, product candidates and other businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts. We have acquired multiple biotechnology companies over the last several years and expect to continue to identify and evaluate such opportunities. The accounting for these acquisitions can vary significantly based on whether we conclude the transactions represent business combinations or asset acquisitions. In 2024, we acquired Alpine and its lead molecule, povetacicept, for approximately $5.0 billion. Povetacicept has shown potential to treat multiple diseases or conditions and become a pipeline-in-a-product. We accounted for the Alpine transaction as an asset acquisition because povetacicept represented substantially all of the fair value of the gross assets that we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed as AIPR&D in 2024. In 2019 and 2022, we acquired Semma Therapeutics, Inc. (“Semma”) and ViaCyte, Inc. (“ViaCyte”), respectively, pursuant to which we established and accelerated the development of our T1D program. We accounted for each of these acquisitions as a business combination.Please refer to our critical accounting policies, “Acquisitions,” for further information regarding the significant judgments and estimates related to our acquisitions.Collaboration and In-Licensing ArrangementsWe enter into arrangements with third parties, including collaboration and licensing arrangements, for the development, manufacture and commercialization of products, product candidates, and other technologies that have the potential to complement our ongoing research and development efforts.Over the last several years, we entered into collaboration agreements with a number of companies, including CRISPR Therapeutics AG (“CRISPR”), Entrada Therapeutics, Inc. (“Entrada”), and Moderna, Inc. Generally, when we in-license a technology or product candidate, we make upfront payments to the collaborator, assume the costs of the program and/or agree to make contingent payments, which could consist of milestone, royalty and option payments. Most of these collaboration payments are expensed as AIPR&D, including, a $75.0 million milestone paid to Entrada in 2024, and, in 2023, total payments of $242.6 million to Entrada and total upfront and milestone payments of $170.0 million to CRISPR related to T1D. These payments were expensed to AIPR&D because they were primarily attributable to acquired in-process research and development for which there was no alternative future use. However, depending on many factors, including the structure of the collaboration, the stage of development of the acquired technology, the significance of the in-licensed product candidate to the collaborator’s operations and the other activities in which our collaborators are engaged, the accounting for these transactions can vary significantly. We expect to continue to identify and evaluate collaboration and licensing opportunities that may be similar to or different from the collaborations and licenses that we have engaged in previously.Joint Development and Commercialization Agreement with CRISPRIn 2017, we entered into a joint development and commercialization agreement with CRISPR (the “CRISPR JDCA”), which we amended and restated in 2021.Pursuant to the CRISPR JDCA, we lead global development, manufacturing and commercialization of CASGEVY, with support from CRISPR. We also conduct all research, development, manufacturing and commercialization activities relating to other product candidates and products under the CRISPR JDCA throughout the world subject to CRISPR’s reserved right to conduct certain activities. products from third-party payors, including governmental organizations in the U.S. and ex-U.S. markets. In the U.S., we work with government and commercial payors to obtain and maintain appropriate levels of reimbursement for our medicines. In ex-U.S. markets, we seek government reimbursement for our medicines on a country-by-country or region-by-region, as required. This is necessary for each new medicine, as well as for label expansions for our current medicines. We expect to continue to focus significant resources to expand and maintain reimbursement for our CF medicines, CASGEVY, JOURNAVX, and, ultimately, our pipeline therapies, in U.S. and ex-U.S. markets."
    },
    {
      "status": "ADDED",
      "current_title": "Strategic Transactions",
      "prior_title": null,
      "current_body": "Acquisitions As part of our business strategy, we seek to acquire technologies, products, product candidates and other businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts. We have acquired multiple biotechnology companies over the last several years and expect to continue to identify and evaluate such opportunities. The accounting for these acquisitions can vary significantly based on whether we conclude the transactions represent business combinations or asset acquisitions. In 2024, we acquired Alpine and its lead molecule, povetacicept, for approximately $5.0 billion. Povetacicept has shown potential to treat multiple diseases or conditions and become a pipeline-in-a-product. We accounted for the Alpine transaction as an asset acquisition because povetacicept represented substantially all of the fair value of the gross assets that we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed as AIPR&D in 2024. In 2019 and 2022, we acquired Semma Therapeutics, Inc. (“Semma”) and ViaCyte, Inc. (“ViaCyte”), respectively, pursuant to which we established and accelerated the development of our T1D program. We accounted for each of these acquisitions as a business combination. Please refer to our critical accounting policies, “Acquisitions,” for further information regarding the significant judgments and estimates related to our acquisitions. Collaboration and In-Licensing Arrangements We enter into arrangements with third parties, including collaboration and licensing arrangements, for the development, manufacture and commercialization of products, product candidates, and other technologies that have the potential to complement our ongoing research and development efforts. Over the last several years, we entered into collaboration agreements with a number of companies, including CRISPR Therapeutics AG (“CRISPR”), Entrada Therapeutics, Inc. (“Entrada”), and Moderna, Inc. Generally, when we in-license a technology or product candidate, we make upfront payments to the collaborator, assume the costs of the program and/or agree to make contingent payments, which could consist of milestone, royalty and option payments. Most of these collaboration payments are expensed as AIPR&D, including, a $75.0 million milestone paid to Entrada in 2024, and, in 2023, total payments of $242.6 million to Entrada and total upfront and milestone payments of $170.0 million to CRISPR related to T1D. These payments were expensed to AIPR&D because they were primarily attributable to acquired in-process research and development for which there was no alternative future use. However, depending on many factors, including the structure of the collaboration, the stage of development of the acquired technology, the significance of the in-licensed product candidate to the collaborator’s operations and the other activities in which our collaborators are engaged, the accounting for these transactions can vary significantly. We expect to continue to identify and evaluate collaboration and licensing opportunities that may be similar to or different from the collaborations and licenses that we have engaged in previously. Joint Development and Commercialization Agreement with CRISPR In 2017, we entered into a joint development and commercialization agreement with CRISPR (the “CRISPR JDCA”), which we amended and restated in 2021. Pursuant to the CRISPR JDCA, we lead global development, manufacturing and commercialization of CASGEVY, with support from CRISPR. We also conduct all research, development, manufacturing and commercialization activities relating to other product candidates and products under the CRISPR JDCA throughout the world subject to CRISPR’s reserved right to conduct certain activities. 49CASGEVY was approved by the FDA in December 2023 for the treatment of SCD. In connection with this approval, we made a $200.0 million milestone payment to CRISPR in January 2024. We are recording intangible asset amortization expense to “Cost of sales” related to this intangible asset. Subsequent to receiving marketing approval for CASGEVY, we continue to lead the research and development activities under the CRISPR JDCA, subject to CRISPR’s reserved right to conduct certain activities. We are reimbursed by CRISPR for its 40% share of these research and development activities, subject to certain adjustments, and we record this reimbursement from CRISPR as a credit within “Research and development expenses.” We also share with CRISPR 40% of the net commercial profits or losses incurred with respect to CASGEVY, subject to certain adjustments, which is recorded to “Cost of sales.” The net commercial profits or losses equal the sum of the product revenues, cost of sales and selling, general and administrative expenses that we have recognized related to the CRISPR JDCA.Prior to receiving marketing approval from the FDA for CASGEVY in December 2023, we accounted for the CRISPR JDCA as a cost-sharing arrangement, with costs incurred related to CASGEVY allocated 60% to us and 40% to CRISPR, subject to certain adjustments. In 2023, we recognized net reimbursements from CRISPR as credits to “Research and development expenses” and to “Selling, general and administrative expenses,” related to CRISPR’s share of the CRISPR JDCA’s operating expenses.Acquired In-Process Research and Development ExpensesIn 2025 and 2024, our AIPR&D included $133.0 million and $4.6 billion, respectively, related to upfront, contingent milestone, or other payments pursuant to our business development transactions, including the asset acquisitions, collaborations, and licenses of third-party technologies described above. Please refer to Note B, “Collaboration, License and Other Arrangements,” for further information regarding our asset acquisitions, collaborations, and in-license agreements.Out-licensing ArrangementsWe also have out-licensed certain development programs to collaborators who are leading the development or commercialization of these programs, either globally or within certain geographic regions.In 2025, we entered into agreements with Zai Lab Limited (“Zai”) and Ono Pharmaceuticals, Co Ltd (“Ono”) respectively, for the development and commercialization of povetacicept in various Asian markets. Zai licensed povetacicept for mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore, while Ono licensed povetacicept for Japan and South Korea. Zai and Ono will help advance povetacicept clinical trials, and will be responsible for obtaining marketing authorizations and commercialization activities, if povetacicept becomes an approved product, in their licensed territories. We are eligible to receive certain future milestone payments and tiered royalties on future net sales of povetacicept in these regions.RESULTS OF OPERATIONSTotal Revenues2025% Change2024% Change2023(in millions, except percentages)TRIKAFTA/KAFTRIO$10,312.71%$10,238.614%$8,944.7ALYFTREK837.8**—**—Other product revenues820.15%781.5(15)%924.5Product revenues, net11,970.69%11,020.112%9,869.2Other revenues30.7**—**—Total revenues$12,001.39%$11,020.112%$9,869.2** Not meaningfulProduct Revenues, NetIn 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 49 49 49 CASGEVY was approved by the FDA in December 2023 for the treatment of SCD. In connection with this approval, we made a $200.0 million milestone payment to CRISPR in January 2024. We are recording intangible asset amortization expense to “Cost of sales” related to this intangible asset. Subsequent to receiving marketing approval for CASGEVY, we continue to lead the research and development activities under the CRISPR JDCA, subject to CRISPR’s reserved right to conduct certain activities. We are reimbursed by CRISPR for its 40% share of these research and development activities, subject to certain adjustments, and we record this reimbursement from CRISPR as a credit within “Research and development expenses.” We also share with CRISPR 40% of the net commercial profits or losses incurred with respect to CASGEVY, subject to certain adjustments, which is recorded to “Cost of sales.” The net commercial profits or losses equal the sum of the product revenues, cost of sales and selling, general and administrative expenses that we have recognized related to the CRISPR JDCA.Prior to receiving marketing approval from the FDA for CASGEVY in December 2023, we accounted for the CRISPR JDCA as a cost-sharing arrangement, with costs incurred related to CASGEVY allocated 60% to us and 40% to CRISPR, subject to certain adjustments. In 2023, we recognized net reimbursements from CRISPR as credits to “Research and development expenses” and to “Selling, general and administrative expenses,” related to CRISPR’s share of the CRISPR JDCA’s operating expenses.Acquired In-Process Research and Development ExpensesIn 2025 and 2024, our AIPR&D included $133.0 million and $4.6 billion, respectively, related to upfront, contingent milestone, or other payments pursuant to our business development transactions, including the asset acquisitions, collaborations, and licenses of third-party technologies described above. Please refer to Note B, “Collaboration, License and Other Arrangements,” for further information regarding our asset acquisitions, collaborations, and in-license agreements.Out-licensing ArrangementsWe also have out-licensed certain development programs to collaborators who are leading the development or commercialization of these programs, either globally or within certain geographic regions.In 2025, we entered into agreements with Zai Lab Limited (“Zai”) and Ono Pharmaceuticals, Co Ltd (“Ono”) respectively, for the development and commercialization of povetacicept in various Asian markets. Zai licensed povetacicept for mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore, while Ono licensed povetacicept for Japan and South Korea. Zai and Ono will help advance povetacicept clinical trials, and will be responsible for obtaining marketing authorizations and commercialization activities, if povetacicept becomes an approved product, in their licensed territories. We are eligible to receive certain future milestone payments and tiered royalties on future net sales of povetacicept in these regions.RESULTS OF OPERATIONSTotal Revenues2025% Change2024% Change2023(in millions, except percentages)TRIKAFTA/KAFTRIO$10,312.71%$10,238.614%$8,944.7ALYFTREK837.8**—**—Other product revenues820.15%781.5(15)%924.5Product revenues, net11,970.69%11,020.112%9,869.2Other revenues30.7**—**—Total revenues$12,001.39%$11,020.112%$9,869.2** Not meaningfulProduct Revenues, NetIn 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and CASGEVY was approved by the FDA in December 2023 for the treatment of SCD. In connection with this approval, we made a $200.0 million milestone payment to CRISPR in January 2024. We are recording intangible asset amortization expense to “Cost of sales” related to this intangible asset. Subsequent to receiving marketing approval for CASGEVY, we continue to lead the research and development activities under the CRISPR JDCA, subject to CRISPR’s reserved right to conduct certain activities. We are reimbursed by CRISPR for its 40% share of these research and development activities, subject to certain adjustments, and we record this reimbursement from CRISPR as a credit within “Research and development expenses.” We also share with CRISPR 40% of the net commercial profits or losses incurred with respect to CASGEVY, subject to certain adjustments, which is recorded to “Cost of sales.” The net commercial profits or losses equal the sum of the product revenues, cost of sales and selling, general and administrative expenses that we have recognized related to the CRISPR JDCA. Prior to receiving marketing approval from the FDA for CASGEVY in December 2023, we accounted for the CRISPR JDCA as a cost-sharing arrangement, with costs incurred related to CASGEVY allocated 60% to us and 40% to CRISPR, subject to certain adjustments. In 2023, we recognized net reimbursements from CRISPR as credits to “Research and development expenses” and to “Selling, general and administrative expenses,” related to CRISPR’s share of the CRISPR JDCA’s operating expenses. Acquired In-Process Research and Development Expenses In 2025 and 2024, our AIPR&D included $133.0 million and $4.6 billion, respectively, related to upfront, contingent milestone, or other payments pursuant to our business development transactions, including the asset acquisitions, collaborations, and licenses of third-party technologies described above. Please refer to Note B, “Collaboration, License and Other Arrangements,” for further information regarding our asset acquisitions, collaborations, and in-license agreements. Out-licensing Arrangements We also have out-licensed certain development programs to collaborators who are leading the development or commercialization of these programs, either globally or within certain geographic regions. In 2025, we entered into agreements with Zai Lab Limited (“Zai”) and Ono Pharmaceuticals, Co Ltd (“Ono”) respectively, for the development and commercialization of povetacicept in various Asian markets. Zai licensed povetacicept for mainland China, Hong Kong SAR, Macau SAR, Taiwan region, and Singapore, while Ono licensed povetacicept for Japan and South Korea. Zai and Ono will help advance povetacicept clinical trials, and will be responsible for obtaining marketing authorizations and commercialization activities, if povetacicept becomes an approved product, in their licensed territories. We are eligible to receive certain future milestone payments and tiered royalties on future net sales of povetacicept in these regions."
    },
    {
      "status": "ADDED",
      "current_title": "Total Revenues",
      "prior_title": null,
      "current_body": "2025% Change2024% Change2023(in millions, except percentages)TRIKAFTA/KAFTRIO$10,312.71%$10,238.614%$8,944.7ALYFTREK837.8**—**—Other product revenues820.15%781.5(15)%924.5Product revenues, net11,970.69%11,020.112%9,869.2Other revenues30.7**—**—Total revenues$12,001.39%$11,020.112%$9,869.2** Not meaningful 2025% Change2024% Change2023(in millions, except percentages)TRIKAFTA/KAFTRIO$10,312.71%$10,238.614%$8,944.7ALYFTREK837.8**—**—Other product revenues820.15%781.5(15)%924.5Product revenues, net11,970.69%11,020.112%9,869.2Other revenues30.7**—**—Total revenues$12,001.39%$11,020.112%$9,869.2** Not meaningful 2025% Change2024% Change2023(in millions, except percentages)TRIKAFTA/KAFTRIO$10,312.71%$10,238.614%$8,944.7ALYFTREK837.8**—**—Other product revenues820.15%781.5(15)%924.5Product revenues, net11,970.69%11,020.112%9,869.2Other revenues30.7**—**—Total revenues$12,001.39%$11,020.112%$9,869.2** Not meaningful 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "Operating Costs and Expenses",
      "prior_title": null,
      "current_body": "2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningful 2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningful 2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningful 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "Non-Operating Income (Expense), Net",
      "prior_title": null,
      "current_body": "Interest Income Interest income decreased from $598.1 million in 2024 to $490.9 million in 2025, primarily due to decreased market interest rates. Our future interest income is dependent on the amount of, and prevailing market interest rates on, our outstanding cash, cash equivalents and available-for-sale debt securities. Other Income (Expense), Net Other income (expense), net were expenses of $7.7 million and $86.1 million in 2025 and 2024, respectively. These amounts primarily related to net unrealized and realized losses resulting from changes in the fair value of certain of our strategic equity investments and net foreign currency exchange losses. Income Taxes Our effective tax rate fluctuates from year to year due to the global nature of our operations. The factors that most significantly impact our effective tax rate include changes in tax laws, variability in the amount and allocation of our taxable earnings among multiple jurisdictions, the amount and characterization of our research and development expenses, the levels of certain deductions and credits, adjustments to the value of our uncertain tax positions, acquisitions and third-party collaboration and licensing transactions. In July 2025, the U.S. enacted H.R.1, which includes significant provisions modifying the U.S. tax framework, including the ability for companies to immediately deduct research and development expenditures for 2025 and provisions for deducting previously capitalized amounts. H.R.1 does not have a material impact on our 2025 U.S. taxes, but we expect further guidance to be issued. We will review guidance when issued for impacts on future years and disclose any impacts if needed at that time. These legislative changes could have an impact on our future effective tax rates, tax liabilities, and cash taxes. Our provision for income taxes was $690.0 million in 2025 and $784.1 million in 2024. In 2025, our 14.9% effective tax rate was lower than the U.S. statutory rate primarily due to research and development tax credits, increased utilization of foreign tax credits, and excess tax benefits related to stock-based compensation. In 2024, our 315.5% effective tax rate was materially different than the U.S. statutory rate primarily due to the $4.4 billion of non-deductible AIPR&D resulting from our acquisition of Alpine, which significantly lowered our pre-tax income. The non-deductible AIPR&D was partially offset by a benefit from a research and development tax credit study that was completed in 2024 and excess tax benefits related to stock-based compensation. 54LIQUIDITY AND CAPITAL RESOURCESThe following table summarizes the components of our financial condition as of December 31, 2025 and 2024:20252024% Change(in millions, except percentages)Cash, cash equivalents and marketable securities:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Long-term marketable securities5,712.35,107.9Total cash, cash equivalents and marketable securities$12,320.4$11,223.810%Working Capital:Total current assets$11,201.0$9,596.417%Total current liabilities(3,861.2)(3,564.6)8%Total working capital$7,339.8$6,031.822%Working CapitalAs of December 31, 2025, total working capital was $7.3 billion, which represented an increase of $1.3 billion, or 22%, from $6.0 billion as of December 31, 2024, primarily due to increased cash and marketable securities due to product revenue growth, as well as increased inventories to support our recent commercial launches.Cash Flows202520242023(in millions)Net cash provided by (used in):Operating activities$3,631.4$(492.6)$3,537.3Investing activities$(945.4)$(3,770.0)$(3,141.7)Financing activities$(2,261.3)$(1,494.9)$(562.2)Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities.Investing ActivitiesCash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing ActivitiesCash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 54 54 54 LIQUIDITY AND CAPITAL RESOURCESThe following table summarizes the components of our financial condition as of December 31, 2025 and 2024:20252024% Change(in millions, except percentages)Cash, cash equivalents and marketable securities:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Long-term marketable securities5,712.35,107.9Total cash, cash equivalents and marketable securities$12,320.4$11,223.810%Working Capital:Total current assets$11,201.0$9,596.417%Total current liabilities(3,861.2)(3,564.6)8%Total working capital$7,339.8$6,031.822%Working CapitalAs of December 31, 2025, total working capital was $7.3 billion, which represented an increase of $1.3 billion, or 22%, from $6.0 billion as of December 31, 2024, primarily due to increased cash and marketable securities due to product revenue growth, as well as increased inventories to support our recent commercial launches.Cash Flows202520242023(in millions)Net cash provided by (used in):Operating activities$3,631.4$(492.6)$3,537.3Investing activities$(945.4)$(3,770.0)$(3,141.7)Financing activities$(2,261.3)$(1,494.9)$(562.2)Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities.Investing ActivitiesCash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing ActivitiesCash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations."
    },
    {
      "status": "ADDED",
      "current_title": "LIQUIDITY AND CAPITAL RESOURCES",
      "prior_title": null,
      "current_body": "The following table summarizes the components of our financial condition as of December 31, 2025 and 2024: 20252024% Change(in millions, except percentages)Cash, cash equivalents and marketable securities:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Long-term marketable securities5,712.35,107.9Total cash, cash equivalents and marketable securities$12,320.4$11,223.810%Working Capital:Total current assets$11,201.0$9,596.417%Total current liabilities(3,861.2)(3,564.6)8%Total working capital$7,339.8$6,031.822% 20252024% Change(in millions, except percentages)Cash, cash equivalents and marketable securities:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Long-term marketable securities5,712.35,107.9Total cash, cash equivalents and marketable securities$12,320.4$11,223.810%Working Capital:Total current assets$11,201.0$9,596.417%Total current liabilities(3,861.2)(3,564.6)8%Total working capital$7,339.8$6,031.822% 20252024% Change(in millions, except percentages)Cash, cash equivalents and marketable securities:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Long-term marketable securities5,712.35,107.9Total cash, cash equivalents and marketable securities$12,320.4$11,223.810%Working Capital:Total current assets$11,201.0$9,596.417%Total current liabilities(3,861.2)(3,564.6)8%Total working capital$7,339.8$6,031.822% 2025 2025 2025 2024 2024 2024 % Change % Change % Change"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except percentages)",
      "prior_title": null,
      "current_body": "TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO TRIKAFTA/KAFTRIO $10,312.7 $10,312.7 $10,312.7 $ 10,312.7 1% 1% 1% $10,238.6 $10,238.6 $10,238.6 $ 10,238.6 14% 14% 14% $8,944.7 $8,944.7 $8,944.7 $ 8,944.7 ALYFTREK ALYFTREK ALYFTREK 837.8 837.8 837.8 837.8 ** ** ** — — — — ** ** ** — — — — Other product revenues Other product revenues Other product revenues 820.1 820.1 820.1 820.1 5% 5% 5% 781.5 781.5 781.5 781.5 (15)% (15)% (15)% 924.5 924.5 924.5 924.5 Product revenues, net Product revenues, net Product revenues, net 11,970.6 11,970.6 11,970.6 11,970.6 9% 9% 9% 11,020.1 11,020.1 11,020.1 11,020.1 12% 12% 12% 9,869.2 9,869.2 9,869.2 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 ** ** ** — — — — ** ** ** — — — — Total revenues Total revenues Total revenues $12,001.3 $12,001.3 $12,001.3 $ 12,001.3 9% 9% 9% $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 12% 12% 12% $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 ** Not meaningful ** Not meaningful ** Not meaningful Product Revenues, Net In 2025, our net product revenues increased $950.5 million, or 9%, as compared to 2024, primarily due to continued strong demand for TRIKAFTA/KAFTRIO as well as contributions from our launches of ALYFTREK, JOURNAVX and 50CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We 50 50 50 CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products.Other RevenuesIn 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively.Revenues by Geographic LocationOur total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2Our U.S. total revenues increased 13% in 2025, as compared to 2024, due to continued strong patient demand, new patient initiations and higher realized net prices. Our ex-U.S. total revenues increased 3% in 2025, as compared to 2024, primarily due to solid CF performance across multiple geographies and increased CASGEVY product revenues, partially offset by a decline in product revenues in Russia, where we are continuing to experience a violation of our intellectual property rights.In 2026, we expect our total revenues to increase due to continued growth of our CF product revenues, including from ALYFTREK globally, and increased contributions from CASGEVY and JOURNAVX.Operating Costs and Expenses2025% Change2024% Change2023(in millions, except percentages)Cost of sales$1,651.38%$1,530.521%$1,262.2Research and development expenses3,909.58%3,630.315%3,162.9Acquired in-process research and development expenses133.0**4,628.4**527.1Selling, general and administrative expenses1,753.120%1,464.329%1,136.6Intangible asset impairment charge379.0**—**—Change in fair value of contingent consideration2.1**(0.5)**(51.6)Total costs and expenses$7,828.0(30)%$11,253.086%$6,037.2** Not meaningfulCost of SalesOur cost of sales primarily consists of third-party royalties payable on net sales of our CF products as well as the cost of producing inventories. Pursuant to our agreement (the “CFF Agreement”) with the Cystic Fibrosis Foundation (the “CFF”), our tiered third-party royalties on sales of ALYFTREK, TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, and ORKAMBI, calculated as a percentage of net sales, range from the single digits to the sub-teens, with lower royalties on sales of ALYFTREK and TRIKAFTA/KAFTRIO than for our other products. The royalty burden associated with TRIKAFTA/KAFTRIO is 9.33% and our position is that the royalty burden associated with ALYFTREK is 4%. On October 10, 2025, Royalty Pharma plc (“RP”), the third party to whom the CFF assigned its rights (and the CFF, which remains a party to the CFF Agreement), initiated a confidential arbitration alleging the royalty burden on ALYFTREK is approximately 8%. RP is seeking a declaratory judgment regarding the royalty burden on ALYFTREK as well as alleged unpaid royalties and other alleged damages available under the CFF Agreement or applicable law, costs, expenses, attorneys’ fees, and interest. We CASGEVY. In 2025, “Other product revenues” included $115.8 million from CASGEVY and $59.6 million from JOURNAVX. In 2024, “Other product revenues” included CASGEVY product revenues of $10.0 million. Our remaining “Other product revenues” are related to KALYDECO, ORKAMBI, and SYMDEKO/SYMKEVI, our other CF products. Other Revenues In 2025, other revenues were $30.7 million, which included $20.6 million and $10.0 million related to upfront payments received from our agreements with Ono and Zai, respectively. Revenues by Geographic Location Our total revenues from the U.S. and from ex-U.S. markets were as follows: 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025% Change2024% Change2023(in millions, except percentages)United States$7,548.613%$6,684.911%$6,040.4ex-U.S.4,452.73%4,335.213%3,828.8Total revenues$12,001.39%$11,020.112%$9,869.2 2025 2025 2025 % Change % Change % Change 2024 2024 2024 % Change % Change % Change 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "Working Capital",
      "prior_title": null,
      "current_body": "As of December 31, 2025, total working capital was $7.3 billion, which represented an increase of $1.3 billion, or 22%, from $6.0 billion as of December 31, 2024, primarily due to increased cash and marketable securities due to product revenue growth, as well as increased inventories to support our recent commercial launches. Cash Flows 202520242023(in millions)Net cash provided by (used in):Operating activities$3,631.4$(492.6)$3,537.3Investing activities$(945.4)$(3,770.0)$(3,141.7)Financing activities$(2,261.3)$(1,494.9)$(562.2) 202520242023(in millions)Net cash provided by (used in):Operating activities$3,631.4$(492.6)$3,537.3Investing activities$(945.4)$(3,770.0)$(3,141.7)Financing activities$(2,261.3)$(1,494.9)$(562.2) 202520242023(in millions)Net cash provided by (used in):Operating activities$3,631.4$(492.6)$3,537.3Investing activities$(945.4)$(3,770.0)$(3,141.7)Financing activities$(2,261.3)$(1,494.9)$(562.2) 2025 2025 2025 2024 2024 2024 2023 2023 2023"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions)",
      "prior_title": null,
      "current_body": "Net cash provided by (used in): Net cash provided by (used in): Net cash provided by (used in): Operating activities Operating activities Operating activities $3,631.4 $3,631.4 $3,631.4 $ 3,631.4 $(492.6) $(492.6) $(492.6) $ (492.6) $3,537.3 $3,537.3 $3,537.3 $ 3,537.3 Investing activities Investing activities Investing activities $(945.4) $(945.4) $(945.4) $ (945.4) $(3,770.0) $(3,770.0) $(3,770.0) $ (3,770.0) $(3,141.7) $(3,141.7) $(3,141.7) $ (3,141.7) Financing activities Financing activities Financing activities $(2,261.3) $(2,261.3) $(2,261.3) $ (2,261.3) $(1,494.9) $(1,494.9) $(1,494.9) $ (1,494.9) $(562.2) $(562.2) $(562.2) $ (562.2) Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities. Investing Activities Cash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing Activities Cash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 55Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 55 55 55 Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below."
    },
    {
      "status": "ADDED",
      "current_title": "Sources and Uses of Liquidity",
      "prior_title": null,
      "current_body": "We intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs. Credit Facilities & Financing Strategy We may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants. We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all."
    },
    {
      "status": "ADDED",
      "current_title": "Future Capital Requirements",
      "prior_title": null,
      "current_body": "We have significant future capital requirements, including: •Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization. •Cash that we pay for income taxes. •Royalties we pay related to sales of our CF products. •Facility, operating and finance lease obligations as described below. •Firm purchase obligations related to our supply and manufacturing processes. In addition, other potential significant future capital requirements may include: •We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital. •To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027. •As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 56Research and Development CostsWe have ongoing clinical trials of product candidates at various stages of clinical development. Our clinical trial costs are dependent on, among other things, the size, number, and length of our clinical trials. These costs can increase as product candidates move from earlier-stage clinical trials into later-stage clinical development.LeasesWe account for the majority of our real estate leases and each of our embedded leases with contract manufacturing organizations as operating leases. These include leases for our corporate headquarters at Fan Pier in Boston, Massachusetts, which continues through June 2044, and office and laboratory space at the Jeffrey Leiden Center for Biologics, Cell and Genetic Therapies Campus (the “Leiden Campus”) near our corporate headquarters. As of December 31, 2025, the longest lease at the Leiden Campus continues through the first quarter of 2042. We also have several embedded leases with contract manufacturing organizations related to the manufacturing and commercialization of our products with remaining lease terms up to 7 years as of December 31, 2025.Our total future minimum lease payments for our leases for each of the next five years and in total are included in Note L, “Leases.” The total future undiscounted minimum lease payments were $3.2 billion and $178.1 million related to our operating and finance leases, respectively, as of December 31, 2025. In addition to the items described above, we have a strategic agreement with Lonza to support the manufacture of T1D cell therapy product candidates, pursuant to which we have partnered with Lonza to build a 130,000 square foot dedicated new facility operated by Lonza in New Hampshire. Lease payments will begin in the first quarter of 2026 and continue through the tenth anniversary of the facility’s regulatory approval for commercial production. We may enter into additional lease agreements to support future product development and commercialization efforts, which would require additional capital.CRITICAL ACCOUNTING POLICIES AND ESTIMATESOur discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements prepared in accordance with generally accepted accounting principles in the U.S. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reported periods. These items are monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are reflected in reported results for the period in which the change occurs. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.We believe that our application of the following accounting policies, each of which requires significant judgments and estimates on the part of management, are the most critical to aid in fully understanding and evaluating our reported financial results:•revenue recognition;•acquisitions, including intangible assets;•pre-launch inventories; and•income taxes.Our accounting policies, including the ones discussed below, are more fully described in Note A, “Nature of Business and Accounting Policies.” 56 56 56 Research and Development CostsWe have ongoing clinical trials of product candidates at various stages of clinical development. Our clinical trial costs are dependent on, among other things, the size, number, and length of our clinical trials. These costs can increase as product candidates move from earlier-stage clinical trials into later-stage clinical development.LeasesWe account for the majority of our real estate leases and each of our embedded leases with contract manufacturing organizations as operating leases. These include leases for our corporate headquarters at Fan Pier in Boston, Massachusetts, which continues through June 2044, and office and laboratory space at the Jeffrey Leiden Center for Biologics, Cell and Genetic Therapies Campus (the “Leiden Campus”) near our corporate headquarters. As of December 31, 2025, the longest lease at the Leiden Campus continues through the first quarter of 2042. We also have several embedded leases with contract manufacturing organizations related to the manufacturing and commercialization of our products with remaining lease terms up to 7 years as of December 31, 2025.Our total future minimum lease payments for our leases for each of the next five years and in total are included in Note L, “Leases.” The total future undiscounted minimum lease payments were $3.2 billion and $178.1 million related to our operating and finance leases, respectively, as of December 31, 2025. In addition to the items described above, we have a strategic agreement with Lonza to support the manufacture of T1D cell therapy product candidates, pursuant to which we have partnered with Lonza to build a 130,000 square foot dedicated new facility operated by Lonza in New Hampshire. Lease payments will begin in the first quarter of 2026 and continue through the tenth anniversary of the facility’s regulatory approval for commercial production. We may enter into additional lease agreements to support future product development and commercialization efforts, which would require additional capital.CRITICAL ACCOUNTING POLICIES AND ESTIMATESOur discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements prepared in accordance with generally accepted accounting principles in the U.S. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reported periods. These items are monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are reflected in reported results for the period in which the change occurs. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate.We believe that our application of the following accounting policies, each of which requires significant judgments and estimates on the part of management, are the most critical to aid in fully understanding and evaluating our reported financial results:•revenue recognition;•acquisitions, including intangible assets;•pre-launch inventories; and•income taxes.Our accounting policies, including the ones discussed below, are more fully described in Note A, “Nature of Business and Accounting Policies.” Research and Development Costs We have ongoing clinical trials of product candidates at various stages of clinical development. Our clinical trial costs are dependent on, among other things, the size, number, and length of our clinical trials. These costs can increase as product candidates move from earlier-stage clinical trials into later-stage clinical development. Leases We account for the majority of our real estate leases and each of our embedded leases with contract manufacturing organizations as operating leases. These include leases for our corporate headquarters at Fan Pier in Boston, Massachusetts, which continues through June 2044, and office and laboratory space at the Jeffrey Leiden Center for Biologics, Cell and Genetic Therapies Campus (the “Leiden Campus”) near our corporate headquarters. As of December 31, 2025, the longest lease at the Leiden Campus continues through the first quarter of 2042. We also have several embedded leases with contract manufacturing organizations related to the manufacturing and commercialization of our products with remaining lease terms up to 7 years as of December 31, 2025. Our total future minimum lease payments for our leases for each of the next five years and in total are included in Note L, “Leases.” The total future undiscounted minimum lease payments were $3.2 billion and $178.1 million related to our operating and finance leases, respectively, as of December 31, 2025. In addition to the items described above, we have a strategic agreement with Lonza to support the manufacture of T1D cell therapy product candidates, pursuant to which we have partnered with Lonza to build a 130,000 square foot dedicated new facility operated by Lonza in New Hampshire. Lease payments will begin in the first quarter of 2026 and continue through the tenth anniversary of the facility’s regulatory approval for commercial production. We may enter into additional lease agreements to support future product development and commercialization efforts, which would require additional capital."
    },
    {
      "status": "ADDED",
      "current_title": "CRITICAL ACCOUNTING POLICIES AND ESTIMATES",
      "prior_title": null,
      "current_body": "Our discussion and analysis of our financial condition and results of operations are based upon our consolidated financial statements prepared in accordance with generally accepted accounting principles in the U.S. The preparation of these financial statements requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reported periods. These items are monitored and analyzed by management for changes in facts and circumstances, and material changes in these estimates could occur in the future. Changes in estimates are reflected in reported results for the period in which the change occurs. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results may differ from our estimates if past experience or other assumptions do not turn out to be substantially accurate. We believe that our application of the following accounting policies, each of which requires significant judgments and estimates on the part of management, are the most critical to aid in fully understanding and evaluating our reported financial results: •revenue recognition; •acquisitions, including intangible assets; •pre-launch inventories; and •income taxes. Our accounting policies, including the ones discussed below, are more fully described in Note A, “Nature of Business and Accounting Policies.” 57Revenue RecognitionProduct Revenues, NetWe generate product revenues from sales in the U.S. and in international markets. We sell our products principally to a limited number of specialty pharmacy and specialty distributors as well as certain major wholesalers in the U.S., which account for the largest portion of our total revenues. Our customers in the U.S. subsequently resell our products to patients, health care providers, retail pharmacies, hospitals, or authorized treatment centers (“ATCs”) for CASGEVY. We contract with government agencies so that our products will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. We make international sales primarily through distributor arrangements and to retail pharmacies, as well as to hospitals and clinics, many of which are government-owned or supported customers. In certain markets, we may not utilize a specialty distributor or specialty pharmacy to distribute CASGEVY. In these markets, we sell CASGEVY directly to ATCs. We recognize net product revenues from sales of our products when our customers obtain control of our products, which typically occurs upon delivery to customers for our small molecule products, including our CF products and JOURNAVX, and upon infusion of our gene-therapy products, including CASGEVY. Revenues from our product sales are recorded at the net sales price, or transaction price, which requires us to make several significant estimates regarding the net sales price. We are required to make estimates for our product revenues related to government, commercial, and private payor rebates, chargebacks, discounts and fees, collectively rebates. The values of the rebates provided to third-party payors per course of treatment vary significantly and are based on government-mandated discounts and our arrangements with other third-party payors. Our most significant estimate relates to determining amounts due pursuant to the Medicaid Drug Rebate Program, including estimating the level of expected utilization of the rebates based on the amount of product sold to eligible patients. We track available information regarding changes, if any, to the payor mix for our products, to our contractual terms with third-party payors and to applicable governmental programs and regulations and levels of our products in the distribution channel. We adjust our estimated rebates based upon new information as it becomes available, including information regarding actual rebates for our products. Claims by third-party payors for rebates are submitted to us significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known.The following table summarizes activity related to our product revenue accruals for rebates for 2025, 2024 and 2023:(in millions)Balance at December 31, 2022$1,291.4Provision related to 2023 sales3,481.4Adjustments related to prior year(s) sales(6.5)Credits/payments made(3,064.7)Balance at December 31, 2023$1,701.6Provision related to 2024 sales3,673.0Adjustments related to prior year(s) sales(42.1)Credits/payments made(3,725.4)Balance at December 31, 2024$1,607.1Provision related to 2025 sales3,780.4Adjustments related to prior year(s) sales(90.4)Credits/payments made(3,519.5)Balance at December 31, 2025$1,777.6We have also entered into annual contracts with government-owned and supported customers in international markets that limit the amount of annual reimbursement we can receive for our products. Upon exceeding the annual reimbursement amount provided by the customer’s contract with us, products are provided free of charge, which is a material right. If we estimate that the annual reimbursement amount under a contract will be exceeded for an annual period, we defer a portion of the consideration received, which includes upfront payments and fees, for shipments made up to the annual reimbursement limit as “Other current liabilities.” Once the annual reimbursement limit has been reached, we recognize the deferred amount 57 57 57 Revenue RecognitionProduct Revenues, NetWe generate product revenues from sales in the U.S. and in international markets. We sell our products principally to a limited number of specialty pharmacy and specialty distributors as well as certain major wholesalers in the U.S., which account for the largest portion of our total revenues. Our customers in the U.S. subsequently resell our products to patients, health care providers, retail pharmacies, hospitals, or authorized treatment centers (“ATCs”) for CASGEVY. We contract with government agencies so that our products will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. We make international sales primarily through distributor arrangements and to retail pharmacies, as well as to hospitals and clinics, many of which are government-owned or supported customers. In certain markets, we may not utilize a specialty distributor or specialty pharmacy to distribute CASGEVY. In these markets, we sell CASGEVY directly to ATCs. We recognize net product revenues from sales of our products when our customers obtain control of our products, which typically occurs upon delivery to customers for our small molecule products, including our CF products and JOURNAVX, and upon infusion of our gene-therapy products, including CASGEVY. Revenues from our product sales are recorded at the net sales price, or transaction price, which requires us to make several significant estimates regarding the net sales price. We are required to make estimates for our product revenues related to government, commercial, and private payor rebates, chargebacks, discounts and fees, collectively rebates. The values of the rebates provided to third-party payors per course of treatment vary significantly and are based on government-mandated discounts and our arrangements with other third-party payors. Our most significant estimate relates to determining amounts due pursuant to the Medicaid Drug Rebate Program, including estimating the level of expected utilization of the rebates based on the amount of product sold to eligible patients. We track available information regarding changes, if any, to the payor mix for our products, to our contractual terms with third-party payors and to applicable governmental programs and regulations and levels of our products in the distribution channel. We adjust our estimated rebates based upon new information as it becomes available, including information regarding actual rebates for our products. Claims by third-party payors for rebates are submitted to us significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known.The following table summarizes activity related to our product revenue accruals for rebates for 2025, 2024 and 2023:(in millions)Balance at December 31, 2022$1,291.4Provision related to 2023 sales3,481.4Adjustments related to prior year(s) sales(6.5)Credits/payments made(3,064.7)Balance at December 31, 2023$1,701.6Provision related to 2024 sales3,673.0Adjustments related to prior year(s) sales(42.1)Credits/payments made(3,725.4)Balance at December 31, 2024$1,607.1Provision related to 2025 sales3,780.4Adjustments related to prior year(s) sales(90.4)Credits/payments made(3,519.5)Balance at December 31, 2025$1,777.6We have also entered into annual contracts with government-owned and supported customers in international markets that limit the amount of annual reimbursement we can receive for our products. Upon exceeding the annual reimbursement amount provided by the customer’s contract with us, products are provided free of charge, which is a material right. If we estimate that the annual reimbursement amount under a contract will be exceeded for an annual period, we defer a portion of the consideration received, which includes upfront payments and fees, for shipments made up to the annual reimbursement limit as “Other current liabilities.” Once the annual reimbursement limit has been reached, we recognize the deferred amount"
    },
    {
      "status": "ADDED",
      "current_title": "Revenue Recognition",
      "prior_title": null,
      "current_body": "Product Revenues, Net We generate product revenues from sales in the U.S. and in international markets. We sell our products principally to a limited number of specialty pharmacy and specialty distributors as well as certain major wholesalers in the U.S., which account for the largest portion of our total revenues. Our customers in the U.S. subsequently resell our products to patients, health care providers, retail pharmacies, hospitals, or authorized treatment centers (“ATCs”) for CASGEVY. We contract with government agencies so that our products will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. We make international sales primarily through distributor arrangements and to retail pharmacies, as well as to hospitals and clinics, many of which are government-owned or supported customers. In certain markets, we may not utilize a specialty distributor or specialty pharmacy to distribute CASGEVY. In these markets, we sell CASGEVY directly to ATCs. We recognize net product revenues from sales of our products when our customers obtain control of our products, which typically occurs upon delivery to customers for our small molecule products, including our CF products and JOURNAVX, and upon infusion of our gene-therapy products, including CASGEVY. Revenues from our product sales are recorded at the net sales price, or transaction price, which requires us to make several significant estimates regarding the net sales price. We are required to make estimates for our product revenues related to government, commercial, and private payor rebates, chargebacks, discounts and fees, collectively rebates. The values of the rebates provided to third-party payors per course of treatment vary significantly and are based on government-mandated discounts and our arrangements with other third-party payors. Our most significant estimate relates to determining amounts due pursuant to the Medicaid Drug Rebate Program, including estimating the level of expected utilization of the rebates based on the amount of product sold to eligible patients. We track available information regarding changes, if any, to the payor mix for our products, to our contractual terms with third-party payors and to applicable governmental programs and regulations and levels of our products in the distribution channel. We adjust our estimated rebates based upon new information as it becomes available, including information regarding actual rebates for our products. Claims by third-party payors for rebates are submitted to us significantly after the related sales, potentially resulting in adjustments in the period in which the new information becomes known. The following table summarizes activity related to our product revenue accruals for rebates for 2025, 2024 and 2023: (in millions)Balance at December 31, 2022$1,291.4Provision related to 2023 sales3,481.4Adjustments related to prior year(s) sales(6.5)Credits/payments made(3,064.7)Balance at December 31, 2023$1,701.6Provision related to 2024 sales3,673.0Adjustments related to prior year(s) sales(42.1)Credits/payments made(3,725.4)Balance at December 31, 2024$1,607.1Provision related to 2025 sales3,780.4Adjustments related to prior year(s) sales(90.4)Credits/payments made(3,519.5)Balance at December 31, 2025$1,777.6 (in millions)Balance at December 31, 2022$1,291.4Provision related to 2023 sales3,481.4Adjustments related to prior year(s) sales(6.5)Credits/payments made(3,064.7)Balance at December 31, 2023$1,701.6Provision related to 2024 sales3,673.0Adjustments related to prior year(s) sales(42.1)Credits/payments made(3,725.4)Balance at December 31, 2024$1,607.1Provision related to 2025 sales3,780.4Adjustments related to prior year(s) sales(90.4)Credits/payments made(3,519.5)Balance at December 31, 2025$1,777.6 (in millions)Balance at December 31, 2022$1,291.4Provision related to 2023 sales3,481.4Adjustments related to prior year(s) sales(6.5)Credits/payments made(3,064.7)Balance at December 31, 2023$1,701.6Provision related to 2024 sales3,673.0Adjustments related to prior year(s) sales(42.1)Credits/payments made(3,725.4)Balance at December 31, 2024$1,607.1Provision related to 2025 sales3,780.4Adjustments related to prior year(s) sales(90.4)Credits/payments made(3,519.5)Balance at December 31, 2025$1,777.6"
    },
    {
      "status": "ADDED",
      "current_title": "(in millions)",
      "prior_title": null,
      "current_body": "Net cash provided by (used in): Net cash provided by (used in): Net cash provided by (used in): Operating activities Operating activities Operating activities $3,631.4 $3,631.4 $3,631.4 $ 3,631.4 $(492.6) $(492.6) $(492.6) $ (492.6) $3,537.3 $3,537.3 $3,537.3 $ 3,537.3 Investing activities Investing activities Investing activities $(945.4) $(945.4) $(945.4) $ (945.4) $(3,770.0) $(3,770.0) $(3,770.0) $ (3,770.0) $(3,141.7) $(3,141.7) $(3,141.7) $ (3,141.7) Financing activities Financing activities Financing activities $(2,261.3) $(2,261.3) $(2,261.3) $ (2,261.3) $(1,494.9) $(1,494.9) $(1,494.9) $ (1,494.9) $(562.2) $(562.2) $(562.2) $ (562.2) Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities. Investing Activities Cash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing Activities Cash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 55Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 55 55 55 Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below."
    },
    {
      "status": "ADDED",
      "current_title": "Acquisitions",
      "prior_title": null,
      "current_body": "As part of our business strategy, we seek to acquire products, product candidates and other technologies and businesses that are aligned with our corporate and research and development strategies and complement and advance our ongoing research and development efforts. We are required to make several significant judgments and estimates to determine the accounting treatment for each acquisition transaction. If we determine that substantially all the fair value associated with an acquisition is concentrated in a single asset, or the acquisition does not constitute a business, we account for it as an asset acquisition. For example, we accounted for our $5.0 billion acquisition of Alpine in 2024 as an asset acquisition because povetacicept, Alpine’s lead molecule, represented substantially all of the fair value of the gross assets that we acquired. As a result, $4.4 billion of the fair value attributed to povetacicept was expensed to AIPR&D in 2024. If the fair value that we acquired in an acquisition is distributed among more than one asset, and the acquisition constitutes a business, we account for it as a business combination. For an asset acquisition involving rights to intellectual property related to in-process research and development that is not yet associated with a product that has achieved regulatory approval, we generally expense our upfront payment to AIPR&D, because there is no alternative future use for the asset that was acquired. For business combinations, we are required to make several significant judgments and estimates to calculate and allocate the purchase price, including the fair value of contingent consideration liabilities, to the assets that we have acquired and the liabilities that we have assumed on our consolidated balance sheet. The most significant judgment and estimate we have made for our business combinations relates to the fair value of the in-process research and development assets. In-process Research and Development Intangible Assets As of December 31, 2025 and 2024, we had $224.6 million and $603.6 million, respectively, of in-process research and development assets on our consolidated balance sheet within “Other intangible assets, net.” During 2025, we recorded a $379.0 million impairment of one of these assets, which was classified as an “Intangible asset impairment charge.” As of December 31, 2025, our remaining indefinite-lived in-process research and development assets were associated with our T1D program. We characterize in-process research and development assets on our consolidated balance sheets as indefinite-lived intangible assets until the completion or abandonment of the associated research and development efforts. We test our in- process research and development intangible assets for impairment on an annual basis, and more frequently if indicators are present or changes in circumstances suggest that impairment may exist. When we determine that an indefinite-lived intangible asset has become impaired or we abandon the associated research and development project, we write down the carrying value to its fair value and record an impairment charge in the period in which the impairment occurs. For example, in 2025, based on results from a Phase 1/2 clinical trial evaluating our VX-264 clinical program in patients with T1D, we concluded that VX-264 will not be advancing further in clinical development. Based on this event, we performed an interim impairment test on the fair value of our VX-264 indefinite-lived in-process research and development asset that we acquired from Semma Therapeutics, Inc. in 2019. We recorded the $379.0 million impairment charge based on the results of this impairment test. We use significant judgment to determine the fair value of our in-process research and development assets and have utilized either the multi-period excess earnings or the relief from royalty methods of the income approach. Each method requires us to estimate the probability of technical and regulatory success, revenue projections and growth rates, and 59appropriate discount and tax rates. The multi-period excess earnings method also requires us to estimate development and commercial costs. The relief from royalty method also requires us to estimate the after-tax royalty savings expected from ownership of the asset that we acquired. In 2025, we used the multi-period earnings method to record the impairment described above.If one of our product candidates achieves regulatory approval, the in-process research and development intangible assets associated with the product candidate become finite-lived intangible assets as described below.Finite-lived Intangible AssetsAs of December 31, 2025 and 2024, we had $199.6 million and $222.3 million, respectively, of finite-lived intangible assets on our consolidated balance sheet within “Other intangible assets, net.” These finite-lived intangible assets primarily relate to $208.0 million of CASGEVY regulatory approval milestones recorded in 2023. We amortize our finite-lived intangible assets related to our marketed products, which represent the majority of our finite-lived intangible assets, using the straight-line method within “Cost of sales” over the remaining estimated life of the assets beginning in the period in which regulatory approval is achieved or the assets are acquired and continuing through the period that we no longer have either exclusive rights to market the products associated with the assets or in-license rights to the intellectual property underlying the assets. We test finite-lived intangible assets for impairment if indicators are present or changes in circumstances suggest that the carrying value of an asset may not be recoverable. If we determine that the carrying value of a finite-lived intangible asset may not be recoverable, we compare the carrying value of the asset to the undiscounted cash flows that we expect the asset to generate. When we determine that a finite-lived intangible asset has become impaired, we write down the carrying value of the asset to its fair value and record an impairment charge in the period in which the impairment occurs.Pre-Launch InventoriesWe capitalize inventories prior to regulatory approval when we consider the related product candidate to have a high likelihood of regulatory approval and expect to recover the related costs. In making this determination, we evaluate, among other factors, the status of regulatory submissions and communications with regulatory authorities, information regarding the product candidate’s safety and efficacy, and the outlook for commercial sales, including the existence of any competition. As an example, during the first quarter of 2024, following positive results related to our Phase 3 trials for JOURNAVX, we began capitalizing inventories produced in preparation for our planned product launch. In January 2025, we received approval from the FDA to market JOURNAVX in the U.S. Prior to making this determination, we expensed inventoriable and related costs associated with JOURNAVX as “Research and development expenses.”Income Taxes We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax basis of assets and liabilities using enacted tax rates in effect for years in which the temporary differences are expected to reverse. If our estimate of the tax effect of reversing temporary differences is (i) not reflective of actual outcomes, (ii) modified to reflect new developments or interpretations of the tax law, or (iii) revised to incorporate new accounting principles, or changes in the expected timing or manner of the reversal, our results of operations could be materially impacted. We provide a valuation allowance when it is more likely than not that deferred tax assets will not be realized. On a periodic basis, we reassess our valuation allowances on our deferred tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. Judgment is required in making these assessments to maintain or adjust our valuation allowances and, to the extent our future expectations change we would have to assess the recoverability of these deferred tax assets at that time. As of December 31, 2025, we maintained a valuation allowance of $326.2 million related primarily to U.S. state tax attributes.We record liabilities related to uncertain tax positions by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We adjust our liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. We are subject to tax laws and audits in multiple jurisdictions and judgment is required in making this assessment. Consequently, we regularly re-evaluate uncertain tax positions and consider various factors, including changes in 59 59 59 appropriate discount and tax rates. The multi-period excess earnings method also requires us to estimate development and commercial costs. The relief from royalty method also requires us to estimate the after-tax royalty savings expected from ownership of the asset that we acquired. In 2025, we used the multi-period earnings method to record the impairment described above.If one of our product candidates achieves regulatory approval, the in-process research and development intangible assets associated with the product candidate become finite-lived intangible assets as described below.Finite-lived Intangible AssetsAs of December 31, 2025 and 2024, we had $199.6 million and $222.3 million, respectively, of finite-lived intangible assets on our consolidated balance sheet within “Other intangible assets, net.” These finite-lived intangible assets primarily relate to $208.0 million of CASGEVY regulatory approval milestones recorded in 2023. We amortize our finite-lived intangible assets related to our marketed products, which represent the majority of our finite-lived intangible assets, using the straight-line method within “Cost of sales” over the remaining estimated life of the assets beginning in the period in which regulatory approval is achieved or the assets are acquired and continuing through the period that we no longer have either exclusive rights to market the products associated with the assets or in-license rights to the intellectual property underlying the assets. We test finite-lived intangible assets for impairment if indicators are present or changes in circumstances suggest that the carrying value of an asset may not be recoverable. If we determine that the carrying value of a finite-lived intangible asset may not be recoverable, we compare the carrying value of the asset to the undiscounted cash flows that we expect the asset to generate. When we determine that a finite-lived intangible asset has become impaired, we write down the carrying value of the asset to its fair value and record an impairment charge in the period in which the impairment occurs.Pre-Launch InventoriesWe capitalize inventories prior to regulatory approval when we consider the related product candidate to have a high likelihood of regulatory approval and expect to recover the related costs. In making this determination, we evaluate, among other factors, the status of regulatory submissions and communications with regulatory authorities, information regarding the product candidate’s safety and efficacy, and the outlook for commercial sales, including the existence of any competition. As an example, during the first quarter of 2024, following positive results related to our Phase 3 trials for JOURNAVX, we began capitalizing inventories produced in preparation for our planned product launch. In January 2025, we received approval from the FDA to market JOURNAVX in the U.S. Prior to making this determination, we expensed inventoriable and related costs associated with JOURNAVX as “Research and development expenses.”Income Taxes We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax basis of assets and liabilities using enacted tax rates in effect for years in which the temporary differences are expected to reverse. If our estimate of the tax effect of reversing temporary differences is (i) not reflective of actual outcomes, (ii) modified to reflect new developments or interpretations of the tax law, or (iii) revised to incorporate new accounting principles, or changes in the expected timing or manner of the reversal, our results of operations could be materially impacted. We provide a valuation allowance when it is more likely than not that deferred tax assets will not be realized. On a periodic basis, we reassess our valuation allowances on our deferred tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. Judgment is required in making these assessments to maintain or adjust our valuation allowances and, to the extent our future expectations change we would have to assess the recoverability of these deferred tax assets at that time. As of December 31, 2025, we maintained a valuation allowance of $326.2 million related primarily to U.S. state tax attributes.We record liabilities related to uncertain tax positions by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We adjust our liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. We are subject to tax laws and audits in multiple jurisdictions and judgment is required in making this assessment. Consequently, we regularly re-evaluate uncertain tax positions and consider various factors, including changes in appropriate discount and tax rates. The multi-period excess earnings method also requires us to estimate development and commercial costs. The relief from royalty method also requires us to estimate the after-tax royalty savings expected from ownership of the asset that we acquired. In 2025, we used the multi-period earnings method to record the impairment described above. If one of our product candidates achieves regulatory approval, the in-process research and development intangible assets associated with the product candidate become finite-lived intangible assets as described below. Finite-lived Intangible Assets As of December 31, 2025 and 2024, we had $199.6 million and $222.3 million, respectively, of finite-lived intangible assets on our consolidated balance sheet within “Other intangible assets, net.” These finite-lived intangible assets primarily relate to $208.0 million of CASGEVY regulatory approval milestones recorded in 2023. We amortize our finite-lived intangible assets related to our marketed products, which represent the majority of our finite-lived intangible assets, using the straight-line method within “Cost of sales” over the remaining estimated life of the assets beginning in the period in which regulatory approval is achieved or the assets are acquired and continuing through the period that we no longer have either exclusive rights to market the products associated with the assets or in-license rights to the intellectual property underlying the assets. We test finite-lived intangible assets for impairment if indicators are present or changes in circumstances suggest that the carrying value of an asset may not be recoverable. If we determine that the carrying value of a finite-lived intangible asset may not be recoverable, we compare the carrying value of the asset to the undiscounted cash flows that we expect the asset to generate. When we determine that a finite-lived intangible asset has become impaired, we write down the carrying value of the asset to its fair value and record an impairment charge in the period in which the impairment occurs."
    },
    {
      "status": "ADDED",
      "current_title": "Pre-Launch Inventories",
      "prior_title": null,
      "current_body": "We capitalize inventories prior to regulatory approval when we consider the related product candidate to have a high likelihood of regulatory approval and expect to recover the related costs. In making this determination, we evaluate, among other factors, the status of regulatory submissions and communications with regulatory authorities, information regarding the product candidate’s safety and efficacy, and the outlook for commercial sales, including the existence of any competition. As an example, during the first quarter of 2024, following positive results related to our Phase 3 trials for JOURNAVX, we began capitalizing inventories produced in preparation for our planned product launch. In January 2025, we received approval from the FDA to market JOURNAVX in the U.S. Prior to making this determination, we expensed inventoriable and related costs associated with JOURNAVX as “Research and development expenses.”"
    },
    {
      "status": "ADDED",
      "current_title": "Income Taxes",
      "prior_title": null,
      "current_body": "We utilize the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial statement carrying amounts and tax basis of assets and liabilities using enacted tax rates in effect for years in which the temporary differences are expected to reverse. If our estimate of the tax effect of reversing temporary differences is (i) not reflective of actual outcomes, (ii) modified to reflect new developments or interpretations of the tax law, or (iii) revised to incorporate new accounting principles, or changes in the expected timing or manner of the reversal, our results of operations could be materially impacted. We provide a valuation allowance when it is more likely than not that deferred tax assets will not be realized. On a periodic basis, we reassess our valuation allowances on our deferred tax assets, weighing positive and negative evidence to assess the recoverability of the deferred tax assets. Judgment is required in making these assessments to maintain or adjust our valuation allowances and, to the extent our future expectations change we would have to assess the recoverability of these deferred tax assets at that time. As of December 31, 2025, we maintained a valuation allowance of $326.2 million related primarily to U.S. state tax attributes. We record liabilities related to uncertain tax positions by prescribing a minimum recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. We adjust our liability to reflect any subsequent changes in the relevant facts and circumstances surrounding the uncertain positions. We are subject to tax laws and audits in multiple jurisdictions and judgment is required in making this assessment. Consequently, we regularly re-evaluate uncertain tax positions and consider various factors, including changes in 60tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. As of December 31, 2025, our liability for uncertain tax positions was $852.1 million. RECENT ACCOUNTING PRONOUNCEMENTSRefer to Note A, “Nature of Business and Accounting Policies,” in the accompanying notes to the consolidated financial statements for a discussion of recent accounting pronouncements and new accounting pronouncements adopted during 2025. ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKInterest Rate RiskFinancial InstrumentsAs part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital, provide adequate liquidity and earn returns commensurate with our risk appetite. We invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of credit exposure to any one issue or type of instrument. These instruments primarily include securities issued by the U.S. government and its agencies, investment-grade corporate bonds, asset-backed securities and money market funds. These investments are primarily denominated in U.S. Dollars and none are held for trading purposes.All of our interest-bearing securities are subject to interest rate risk and could change in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments. Since we account for these securities as available-for-sale, no gains or losses are realized due to changes in the fair value of our investments unless we sell our investments prior to maturity or incur a credit loss. Due to the conservative nature of these instruments, we do not believe that the fair value of our investments has a material exposure to interest rate risk.While we are exposed to global interest rate fluctuations, our investment portfolio is most affected by fluctuations in U.S. interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities. Credit AgreementIn 2022, we entered into a $500.0 million unsecured revolving credit facility (“credit agreement”). Loans under this credit agreement bear interest, at our option, at a base rate or a Secured Overnight Financing Rate (“SOFR”), plus an applicable margin based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our consolidated EBITDA for the most recently completed four fiscal quarter period). Pursuant to our credit agreement, the applicable margin on base rate loans ranges from 0.000% to 0.500% and the applicable margin on SOFR loans ranges from 1.000% to 1.500%. We do not believe that changes in interest rates related to our credit agreement would have a material effect on our consolidated financial statements. As of December 31, 2025, we had no principal or interest outstanding under our credit facility. A portion of our “Interest expense” in 2026 will be dependent on whether, and to what extent, we borrow amounts under this facility. Foreign Exchange Market RiskAs a result of our foreign operations, we face significant exposure to movements in foreign currency exchange rates between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. Fluctuations in the amounts of our foreign revenues and fluctuations in foreign currency exchange rates, may have a positive or negative effect on our foreign exchange rate exposure. The current exposures arise primarily from cash, accounts receivable, intercompany receivables and payables, payables, and accruals, and inventories.We have a foreign currency management program, which is separate from our investment policy and portfolio, with the objective of reducing the effect of exchange rate fluctuations on our operating results and forecasted revenues denominated in foreign currencies. We have cash flow hedges related to a portion of our forecasted product revenues that qualify for hedge accounting treatment under U.S. GAAP. We do not seek hedge accounting treatment for our foreign currency forward contracts related to monetary assets and liabilities that impact our operating results. As of December 31, 2025, we held foreign exchange forward contracts that were designated as cash flow hedges with notional amounts totaling $6.1 billion representing a net liability of $111.5 million on our consolidated balance sheet. 60 60 60 tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. As of December 31, 2025, our liability for uncertain tax positions was $852.1 million. RECENT ACCOUNTING PRONOUNCEMENTSRefer to Note A, “Nature of Business and Accounting Policies,” in the accompanying notes to the consolidated financial statements for a discussion of recent accounting pronouncements and new accounting pronouncements adopted during 2025. ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKInterest Rate RiskFinancial InstrumentsAs part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital, provide adequate liquidity and earn returns commensurate with our risk appetite. We invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of credit exposure to any one issue or type of instrument. These instruments primarily include securities issued by the U.S. government and its agencies, investment-grade corporate bonds, asset-backed securities and money market funds. These investments are primarily denominated in U.S. Dollars and none are held for trading purposes.All of our interest-bearing securities are subject to interest rate risk and could change in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments. Since we account for these securities as available-for-sale, no gains or losses are realized due to changes in the fair value of our investments unless we sell our investments prior to maturity or incur a credit loss. Due to the conservative nature of these instruments, we do not believe that the fair value of our investments has a material exposure to interest rate risk.While we are exposed to global interest rate fluctuations, our investment portfolio is most affected by fluctuations in U.S. interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities. Credit AgreementIn 2022, we entered into a $500.0 million unsecured revolving credit facility (“credit agreement”). Loans under this credit agreement bear interest, at our option, at a base rate or a Secured Overnight Financing Rate (“SOFR”), plus an applicable margin based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our consolidated EBITDA for the most recently completed four fiscal quarter period). Pursuant to our credit agreement, the applicable margin on base rate loans ranges from 0.000% to 0.500% and the applicable margin on SOFR loans ranges from 1.000% to 1.500%. We do not believe that changes in interest rates related to our credit agreement would have a material effect on our consolidated financial statements. As of December 31, 2025, we had no principal or interest outstanding under our credit facility. A portion of our “Interest expense” in 2026 will be dependent on whether, and to what extent, we borrow amounts under this facility. Foreign Exchange Market RiskAs a result of our foreign operations, we face significant exposure to movements in foreign currency exchange rates between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. Fluctuations in the amounts of our foreign revenues and fluctuations in foreign currency exchange rates, may have a positive or negative effect on our foreign exchange rate exposure. The current exposures arise primarily from cash, accounts receivable, intercompany receivables and payables, payables, and accruals, and inventories.We have a foreign currency management program, which is separate from our investment policy and portfolio, with the objective of reducing the effect of exchange rate fluctuations on our operating results and forecasted revenues denominated in foreign currencies. We have cash flow hedges related to a portion of our forecasted product revenues that qualify for hedge accounting treatment under U.S. GAAP. We do not seek hedge accounting treatment for our foreign currency forward contracts related to monetary assets and liabilities that impact our operating results. As of December 31, 2025, we held foreign exchange forward contracts that were designated as cash flow hedges with notional amounts totaling $6.1 billion representing a net liability of $111.5 million on our consolidated balance sheet. tax law, the measurement of tax positions taken or expected to be taken in tax returns, and changes in facts or circumstances related to a tax position. As of December 31, 2025, our liability for uncertain tax positions was $852.1 million."
    },
    {
      "status": "ADDED",
      "current_title": "RECENT ACCOUNTING PRONOUNCEMENTS",
      "prior_title": null,
      "current_body": "Refer to Note A, “Nature of Business and Accounting Policies,” in the accompanying notes to the consolidated financial statements for a discussion of recent accounting pronouncements and new accounting pronouncements adopted during 2025. ITEM 7A.QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK"
    },
    {
      "status": "ADDED",
      "current_title": "Interest Rate Risk",
      "prior_title": null,
      "current_body": "Financial Instruments As part of our investment portfolio, we own financial instruments that are sensitive to market risks. The investment portfolio is used to preserve our capital, provide adequate liquidity and earn returns commensurate with our risk appetite. We invest in instruments that meet the credit quality standards outlined in our investment policy, which also limits the amount of credit exposure to any one issue or type of instrument. These instruments primarily include securities issued by the U.S. government and its agencies, investment-grade corporate bonds, asset-backed securities and money market funds. These investments are primarily denominated in U.S. Dollars and none are held for trading purposes. All of our interest-bearing securities are subject to interest rate risk and could change in value if interest rates fluctuate. Substantially all of our investment portfolio consists of marketable securities with active secondary or resale markets to help ensure portfolio liquidity, and we have implemented guidelines limiting the term-to-maturity of our investment instruments. Since we account for these securities as available-for-sale, no gains or losses are realized due to changes in the fair value of our investments unless we sell our investments prior to maturity or incur a credit loss. Due to the conservative nature of these instruments, we do not believe that the fair value of our investments has a material exposure to interest rate risk. While we are exposed to global interest rate fluctuations, our investment portfolio is most affected by fluctuations in U.S. interest rates, which affect the interest earned on our cash, cash equivalents and marketable securities. Credit Agreement In 2022, we entered into a $500.0 million unsecured revolving credit facility (“credit agreement”). Loans under this credit agreement bear interest, at our option, at a base rate or a Secured Overnight Financing Rate (“SOFR”), plus an applicable margin based on our consolidated leverage ratio (the ratio of our total consolidated funded indebtedness to our consolidated EBITDA for the most recently completed four fiscal quarter period). Pursuant to our credit agreement, the applicable margin on base rate loans ranges from 0.000% to 0.500% and the applicable margin on SOFR loans ranges from 1.000% to 1.500%. We do not believe that changes in interest rates related to our credit agreement would have a material effect on our consolidated financial statements. As of December 31, 2025, we had no principal or interest outstanding under our credit facility. A portion of our “Interest expense” in 2026 will be dependent on whether, and to what extent, we borrow amounts under this facility."
    },
    {
      "status": "ADDED",
      "current_title": "Foreign Exchange Market Risk",
      "prior_title": null,
      "current_body": "As a result of our foreign operations, we face significant exposure to movements in foreign currency exchange rates between the U.S. dollar and various foreign currencies, the most significant of which is the Euro. Fluctuations in the amounts of our foreign revenues and fluctuations in foreign currency exchange rates, may have a positive or negative effect on our foreign exchange rate exposure. The current exposures arise primarily from cash, accounts receivable, intercompany receivables and payables, payables, and accruals, and inventories. We have a foreign currency management program, which is separate from our investment policy and portfolio, with the objective of reducing the effect of exchange rate fluctuations on our operating results and forecasted revenues denominated in foreign currencies. We have cash flow hedges related to a portion of our forecasted product revenues that qualify for hedge accounting treatment under U.S. GAAP. We do not seek hedge accounting treatment for our foreign currency forward contracts related to monetary assets and liabilities that impact our operating results. As of December 31, 2025, we held foreign exchange forward contracts that were designated as cash flow hedges with notional amounts totaling $6.1 billion representing a net liability of $111.5 million on our consolidated balance sheet. 61Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably possible near-term change in exchange rates. If the December 31, 2025 exchange rates were to change by a hypothetical 10%, the fair value recorded on our consolidated balance sheet related to our foreign exchange forward contracts that were designated as cash flow hedges as of December 31, 2025 would change by approximately $608.0 million. However, since these contracts hedge a specific portion of our forecasted product revenues denominated in certain foreign currencies, any change in the fair value of these contracts is recorded in “Accumulated other comprehensive (loss) income” on our consolidated balance sheets and is reclassified to earnings in the same periods during which the underlying product revenues affect earnings. Therefore, any change in the fair value of these contracts that would result from a hypothetical 10% change in exchange rates would be entirely offset by the change in value associated with the underlying hedged product revenues resulting in no impact on our future anticipated earnings and cash flows with respect to the hedged portion of our forecasted product revenues.ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAThe information required by this Item 8 is contained on pages F-1 through F-49 of this Annual Report on Form 10-K. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENot applicable.ITEM 9A.CONTROLS AND PROCEDURES(1) Evaluation of Disclosure Controls and Procedures. Our chief executive officer and chief financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and procedures were effective. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures.(2) Management’s Annual Report on Internal Control Over Financial Reporting. Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting include those policies and procedures that:•pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;•provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our directors; and•provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, we used the criteria set forth in the Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on our assessment, management has concluded that, as of December 31, 2025, our internal control over financial reporting is effective based on those criteria. 61 61 61 Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably possible near-term change in exchange rates. If the December 31, 2025 exchange rates were to change by a hypothetical 10%, the fair value recorded on our consolidated balance sheet related to our foreign exchange forward contracts that were designated as cash flow hedges as of December 31, 2025 would change by approximately $608.0 million. However, since these contracts hedge a specific portion of our forecasted product revenues denominated in certain foreign currencies, any change in the fair value of these contracts is recorded in “Accumulated other comprehensive (loss) income” on our consolidated balance sheets and is reclassified to earnings in the same periods during which the underlying product revenues affect earnings. Therefore, any change in the fair value of these contracts that would result from a hypothetical 10% change in exchange rates would be entirely offset by the change in value associated with the underlying hedged product revenues resulting in no impact on our future anticipated earnings and cash flows with respect to the hedged portion of our forecasted product revenues.ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAThe information required by this Item 8 is contained on pages F-1 through F-49 of this Annual Report on Form 10-K. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURENot applicable.ITEM 9A.CONTROLS AND PROCEDURES(1) Evaluation of Disclosure Controls and Procedures. Our chief executive officer and chief financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and procedures were effective. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures.(2) Management’s Annual Report on Internal Control Over Financial Reporting. Management is responsible for establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting include those policies and procedures that:•pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets;•provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our directors; and•provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, we used the criteria set forth in the Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on our assessment, management has concluded that, as of December 31, 2025, our internal control over financial reporting is effective based on those criteria. Although not predictive in nature, we believe a hypothetical 10% threshold reflects a reasonably possible near-term change in exchange rates. If the December 31, 2025 exchange rates were to change by a hypothetical 10%, the fair value recorded on our consolidated balance sheet related to our foreign exchange forward contracts that were designated as cash flow hedges as of December 31, 2025 would change by approximately $608.0 million. However, since these contracts hedge a specific portion of our forecasted product revenues denominated in certain foreign currencies, any change in the fair value of these contracts is recorded in “Accumulated other comprehensive (loss) income” on our consolidated balance sheets and is reclassified to earnings in the same periods during which the underlying product revenues affect earnings. Therefore, any change in the fair value of these contracts that would result from a hypothetical 10% change in exchange rates would be entirely offset by the change in value associated with the underlying hedged product revenues resulting in no impact on our future anticipated earnings and cash flows with respect to the hedged portion of our forecasted product revenues. ITEM 8.FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA The information required by this Item 8 is contained on pages F-1 through F-49 of this Annual Report on Form 10-K. ITEM 9.CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND"
    },
    {
      "status": "ADDED",
      "current_title": "FINANCIAL DISCLOSURE",
      "prior_title": null,
      "current_body": "Not applicable. ITEM 9A.CONTROLS AND PROCEDURES (1) Evaluation of Disclosure Controls and Procedures. Our chief executive officer and chief financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rule 13a-15(e) and Rule 15d-15(e) promulgated under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)) as of the end of the period covered by this Annual Report on Form 10-K, have concluded that, based on such evaluation, our disclosure controls and procedures were effective. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply our judgment in evaluating the cost-benefit relationship of possible controls and procedures."
    },
    {
      "status": "ADDED",
      "current_title": "(2) Management’s Annual Report on Internal Control Over Financial Reporting. Management is responsible for",
      "prior_title": null,
      "current_body": "establishing and maintaining adequate internal control over financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and Rule 15d-15(f) promulgated under the Exchange Act, as a process designed by, or under the supervision of, our principal executive and principal financial officers and effected by our board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. Our internal control over financial reporting include those policies and procedures that: •pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of our assets; •provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of management and our directors; and •provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Management assessed the effectiveness of our internal control over financial reporting as of December 31, 2025. In making this assessment, we used the criteria set forth in the Internal Control—Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (“COSO”). Based on our assessment, management has concluded that, as of December 31, 2025, our internal control over financial reporting is effective based on those criteria. 62Our independent registered public accounting firm, Ernst & Young LLP, issued an attestation report on our internal control over financial reporting. See Section 4 below.(3) Changes in Internal Controls. During the quarter ended December 31, 2025, there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 62 62 62 Our independent registered public accounting firm, Ernst & Young LLP, issued an attestation report on our internal control over financial reporting. See Section 4 below.(3) Changes in Internal Controls. During the quarter ended December 31, 2025, there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. Our independent registered public accounting firm, Ernst & Young LLP, issued an attestation report on our internal control over financial reporting. See Section 4 below. (3) Changes in Internal Controls. During the quarter ended December 31, 2025, there were no changes in our internal control over financial reporting that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 63(4) Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Vertex Pharmaceuticals IncorporatedOpinion on Internal Control Over Financial Reporting We have audited Vertex Pharmaceuticals Incorporated’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Vertex Pharmaceuticals Incorporated (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 13, 2026 expressed an unqualified opinion thereon.Basis for OpinionThe Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.Definition and Limitations of Internal Control Over Financial ReportingA company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate./s/ Ernst & Young LLPBoston, MassachusettsFebruary 13, 2026 63 63 63 (4) Report of Independent Registered Public Accounting Firm To the Shareholders and the Board of Directors of Vertex Pharmaceuticals IncorporatedOpinion on Internal Control Over Financial Reporting We have audited Vertex Pharmaceuticals Incorporated’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Vertex Pharmaceuticals Incorporated (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria.We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 13, 2026 expressed an unqualified opinion thereon.Basis for OpinionThe Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion.Definition and Limitations of Internal Control Over Financial ReportingA company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements.Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate./s/ Ernst & Young LLPBoston, MassachusettsFebruary 13, 2026"
    },
    {
      "status": "ADDED",
      "current_title": "(4) Report of Independent Registered Public Accounting Firm",
      "prior_title": null,
      "current_body": "To the Shareholders and the Board of Directors of Vertex Pharmaceuticals Incorporated"
    },
    {
      "status": "ADDED",
      "current_title": "Opinion on Internal Control Over Financial Reporting",
      "prior_title": null,
      "current_body": "We have audited Vertex Pharmaceuticals Incorporated’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework) (the COSO criteria). In our opinion, Vertex Pharmaceuticals Incorporated (the Company) maintained, in all material respects, effective internal control over financial reporting as of December 31, 2025, based on the COSO criteria. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the 2025 consolidated financial statements of the Company and our report dated February 13, 2026 expressed an unqualified opinion thereon."
    },
    {
      "status": "ADDED",
      "current_title": "Basis for Opinion",
      "prior_title": null,
      "current_body": "The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion."
    },
    {
      "status": "ADDED",
      "current_title": "Definition and Limitations of Internal Control Over Financial Reporting",
      "prior_title": null,
      "current_body": "A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/ Ernst & Young LLP Boston, Massachusetts February 13, 2026 64ITEM 9B. OTHER INFORMATIONRule 10b5-1 Trading PlansOur policy governing transactions in our securities by our directors, officers, and employees permits our officers, directors and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities adopted by our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) during the fourth quarter of 2025, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1 (each, a “Trading Plan”). Other than as described in the table below, none of our directors or officers adopted, modified or terminated a Trading Plan in the fourth quarter of 2025.Name and TitleDate of Adoption of Trading PlanScheduled Expiration Date of Trading Plan(1)Maximum Shares Subject to Trading PlanReshma KewalramaniChief Executive Officer and President11/17/202511/16/202640,000Amit SachdevEVP, Chief Patient and External Affairs Officer11/18/202510/30/202670,498(2)Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer11/20/202511/02/202634,733(2)Duncan McKechnieEVP, Chief Commercial Officer11/25/202511/13/202617,367(2)(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.(2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable.2026 Restated Articles of OrganizationOn February 12, 2026, the Company filed Restated Articles of Organization with the Secretary of the Commonwealth of Massachusetts to consolidate its Articles of Organization and all prior amendments and to remove references to the Series A Junior Participating Preferred Stock, which is no longer outstanding. The restatement was effected for clarity only and did not result in any changes to the rights of holders of the Company’s common stock. A copy of the Restated Articles of Organization is filed as Exhibit 3.1 to this Annual Report on Form 10-K and is incorporated herein by reference.ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.None. 64 64 64 ITEM 9B. OTHER INFORMATIONRule 10b5-1 Trading PlansOur policy governing transactions in our securities by our directors, officers, and employees permits our officers, directors and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities adopted by our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) during the fourth quarter of 2025, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1 (each, a “Trading Plan”). Other than as described in the table below, none of our directors or officers adopted, modified or terminated a Trading Plan in the fourth quarter of 2025.Name and TitleDate of Adoption of Trading PlanScheduled Expiration Date of Trading Plan(1)Maximum Shares Subject to Trading PlanReshma KewalramaniChief Executive Officer and President11/17/202511/16/202640,000Amit SachdevEVP, Chief Patient and External Affairs Officer11/18/202510/30/202670,498(2)Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer11/20/202511/02/202634,733(2)Duncan McKechnieEVP, Chief Commercial Officer11/25/202511/13/202617,367(2)(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.(2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable.2026 Restated Articles of OrganizationOn February 12, 2026, the Company filed Restated Articles of Organization with the Secretary of the Commonwealth of Massachusetts to consolidate its Articles of Organization and all prior amendments and to remove references to the Series A Junior Participating Preferred Stock, which is no longer outstanding. The restatement was effected for clarity only and did not result in any changes to the rights of holders of the Company’s common stock. A copy of the Restated Articles of Organization is filed as Exhibit 3.1 to this Annual Report on Form 10-K and is incorporated herein by reference.ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS.None. ITEM 9B. OTHER INFORMATION Rule 10b5-1 Trading Plans Our policy governing transactions in our securities by our directors, officers, and employees permits our officers, directors and employees to enter into trading plans complying with Rule 10b5-1 under the Exchange Act. The following table describes the written plans for the sale of our securities adopted by our directors and officers (as defined in Rule 16a-1(f) under the Exchange Act) during the fourth quarter of 2025, each of which is intended to satisfy the affirmative defense conditions of Rule 10b5-1 (each, a “Trading Plan”). Other than as described in the table below, none of our directors or officers adopted, modified or terminated a Trading Plan in the fourth quarter of 2025. Name and TitleDate of Adoption of Trading PlanScheduled Expiration Date of Trading Plan(1)Maximum Shares Subject to Trading PlanReshma KewalramaniChief Executive Officer and President11/17/202511/16/202640,000Amit SachdevEVP, Chief Patient and External Affairs Officer11/18/202510/30/202670,498(2)Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer11/20/202511/02/202634,733(2)Duncan McKechnieEVP, Chief Commercial Officer11/25/202511/13/202617,367(2)(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.(2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. Name and TitleDate of Adoption of Trading PlanScheduled Expiration Date of Trading Plan(1)Maximum Shares Subject to Trading PlanReshma KewalramaniChief Executive Officer and President11/17/202511/16/202640,000Amit SachdevEVP, Chief Patient and External Affairs Officer11/18/202510/30/202670,498(2)Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer11/20/202511/02/202634,733(2)Duncan McKechnieEVP, Chief Commercial Officer11/25/202511/13/202617,367(2)(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.(2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. Name and TitleDate of Adoption of Trading PlanScheduled Expiration Date of Trading Plan(1)Maximum Shares Subject to Trading PlanReshma KewalramaniChief Executive Officer and President11/17/202511/16/202640,000Amit SachdevEVP, Chief Patient and External Affairs Officer11/18/202510/30/202670,498(2)Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer11/20/202511/02/202634,733(2)Duncan McKechnieEVP, Chief Commercial Officer11/25/202511/13/202617,367(2)(1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan.(2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable."
    },
    {
      "status": "ADDED",
      "current_title": "Subject to Trading",
      "prior_title": null,
      "current_body": "Plan Reshma KewalramaniChief Executive Officer and President Reshma KewalramaniChief Executive Officer and President Reshma Kewalramani Chief Executive Officer and President 11/17/2025 11/17/2025 11/17/2025 11/16/2026 11/16/2026 11/16/2026 40,000 40,000 40,000 Amit SachdevEVP, Chief Patient and External Affairs Officer Amit SachdevEVP, Chief Patient and External Affairs Officer Amit Sachdev EVP, Chief Patient and External Affairs Officer 11/18/2025 11/18/2025 11/18/2025 10/30/2026 10/30/2026 10/30/2026 70,498(2) 70,498(2) 70,498(2) Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer Carmen BozicEVP, Global Medicines Development and Medical Affairs, Chief Medical Officer Carmen Bozic EVP, Global Medicines Development and Medical Affairs, Chief Medical Officer 11/20/2025 11/20/2025 11/20/2025 11/02/2026 11/02/2026 11/02/2026 34,733(2) 34,733(2) 34,733(2) Duncan McKechnieEVP, Chief Commercial Officer Duncan McKechnieEVP, Chief Commercial Officer Duncan McKechnie EVP, Chief Commercial Officer 11/25/2025 11/25/2025 11/25/2025 11/13/2026 11/13/2026 11/13/2026 17,367(2) 17,367(2) 17,367(2) (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. (1) A Trading Plan may expire on an earlier date if all contemplated transactions are completed before such Trading Plan’s expiration date, upon termination by broker or the holder of the Trading Plan, or as otherwise provided in the Trading Plan. (2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. (2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. (2) The maximum shares listed has not been reduced by the number of shares of common stock that will be withheld to satisfy tax withholding obligations at future vesting dates because such number of shares is not yet determinable. 2026 Restated Articles of Organization On February 12, 2026, the Company filed Restated Articles of Organization with the Secretary of the Commonwealth of Massachusetts to consolidate its Articles of Organization and all prior amendments and to remove references to the Series A Junior Participating Preferred Stock, which is no longer outstanding. The restatement was effected for clarity only and did not result in any changes to the rights of holders of the Company’s common stock. A copy of the Restated Articles of Organization is filed as Exhibit 3.1 to this Annual Report on Form 10-K and is incorporated herein by reference. ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS. None. 65PART IIIPortions of our definitive Proxy Statement for the 2026 Annual Meeting of Shareholders (“2026 Proxy Statement”) are incorporated by reference into this Part III of our Annual Report on Form 10-K.ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEThe information regarding directors required by this Item 10 will be included in our 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” “Shareholder Proposals for the 2027 Annual Meeting and Nominations for Director,” “Delinquent Section 16(a) Reports” and “Code of Conduct.” The information regarding executive officers required by this Item 10 is included in Part I of this Annual Report on Form 10-K.We have adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of our securities by directors, officers and employees, or Vertex itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations and any listing standards applicable to us. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.ITEM 11.EXECUTIVE COMPENSATIONThe information required by this Item 11 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Compensation Committee Interlocks and Insider Participation,” “Compensation Discussion and Analysis,” “Compensation and Equity Tables,” “Director Compensation,” “Management Development and Compensation Committee Report” and/or “Corporate Governance and Risk Management.”ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERSThe information required by this Item 12 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information.” ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this Item 13 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” and “Audit and Finance Committee.”ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this Item 14 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Ratification of the Appointment of Independent Registered Public Accounting Firm.” 65 65 65 PART IIIPortions of our definitive Proxy Statement for the 2026 Annual Meeting of Shareholders (“2026 Proxy Statement”) are incorporated by reference into this Part III of our Annual Report on Form 10-K.ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCEThe information regarding directors required by this Item 10 will be included in our 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” “Shareholder Proposals for the 2027 Annual Meeting and Nominations for Director,” “Delinquent Section 16(a) Reports” and “Code of Conduct.” The information regarding executive officers required by this Item 10 is included in Part I of this Annual Report on Form 10-K.We have adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of our securities by directors, officers and employees, or Vertex itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations and any listing standards applicable to us. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K.ITEM 11.EXECUTIVE COMPENSATIONThe information required by this Item 11 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Compensation Committee Interlocks and Insider Participation,” “Compensation Discussion and Analysis,” “Compensation and Equity Tables,” “Director Compensation,” “Management Development and Compensation Committee Report” and/or “Corporate Governance and Risk Management.”ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERSThe information required by this Item 12 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information.” ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCEThe information required by this Item 13 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” and “Audit and Finance Committee.”ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICESThe information required by this Item 14 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Ratification of the Appointment of Independent Registered Public Accounting Firm.” PART III Portions of our definitive Proxy Statement for the 2026 Annual Meeting of Shareholders (“2026 Proxy Statement”) are incorporated by reference into this Part III of our Annual Report on Form 10-K. ITEM 10.DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE The information regarding directors required by this Item 10 will be included in our 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” “Shareholder Proposals for the 2027 Annual Meeting and Nominations for Director,” “Delinquent Section 16(a) Reports” and “Code of Conduct.” The information regarding executive officers required by this Item 10 is included in Part I of this Annual Report on Form 10-K. We have adopted insider trading policies and procedures governing the purchase, sale and/or other dispositions of our securities by directors, officers and employees, or Vertex itself, that are reasonably designed to promote compliance with insider trading laws, rules and regulations and any listing standards applicable to us. A copy of our Insider Trading Policy is filed as Exhibit 19.1 to this Annual Report on Form 10-K. ITEM 11.EXECUTIVE COMPENSATION The information required by this Item 11 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Compensation Committee Interlocks and Insider Participation,” “Compensation Discussion and Analysis,” “Compensation and Equity Tables,” “Director Compensation,” “Management Development and Compensation Committee Report” and/or “Corporate Governance and Risk Management.” ITEM 12.SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND"
    },
    {
      "status": "ADDED",
      "current_title": "RELATED STOCKHOLDER MATTERS",
      "prior_title": null,
      "current_body": "The information required by this Item 12 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Security Ownership of Certain Beneficial Owners and Management” and “Equity Compensation Plan Information.” ITEM 13.CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE The information required by this Item 13 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Election of Directors,” “Corporate Governance and Risk Management,” and “Audit and Finance Committee.” ITEM 14.PRINCIPAL ACCOUNTANT FEES AND SERVICES The information required by this Item 14 will be included in the 2026 Proxy Statement and is incorporated herein by reference. We expect this information to be provided under “Ratification of the Appointment of Independent Registered Public Accounting Firm.” 66PART IVITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES(a)(1) The Financial Statements required to be filed by Items 8 and 15(c) of Form 10-K, and filed herewith, are as follows:Page Number in this Form 10-KReport of Independent Registered Public Accounting Firm (PCAOB ID: 42) .......................................................F-1Consolidated Statements of Income (Loss) .........................................................................................................................F-3Consolidated Statements of Comprehensive Income (Loss) ...............................................................................................F-4Consolidated Balance Sheets ...............................................................................................................................................F-5Consolidated Statements of Shareholders’ Equity ...............................................................................................................F-6Consolidated Statements of Cash Flows ..............................................................................................................................F-7Notes to Consolidated Financial Statements ........................................................................................................................F-8(a)(2) Financial Statement Schedules have been omitted because they are either not applicable or the required information is included in the consolidated financial statements or notes thereto listed in (a)(1) above.(a)(3) Exhibits.The following is a list of exhibits filed as part of this Annual Report on Form 10-K. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. NumberGovernance Documents3.1Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended.X3.2Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.10-K(Exhibit 3.2)February 13, 2025000-19319Stock Certificate4.1Specimen Stock Certificate.10-K(Exhibit 4.1)February 15, 2018000-193194.2Description of Securities.10-K(Exhibit 4.2)February 13, 2025000-19319Collaboration Agreement10.1Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.1)November 3, 2021000-1931910.2Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.2)November 3, 2021000-1931910.3Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.10-Q/A(Exhibit 10.6)August 19, 2011000-1931910.4Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.3)November 3, 2021000-1931910.5Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.4)November 3, 2021000-19319 66 66 66 PART IVITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES(a)(1) The Financial Statements required to be filed by Items 8 and 15(c) of Form 10-K, and filed herewith, are as follows:Page Number in this Form 10-KReport of Independent Registered Public Accounting Firm (PCAOB ID: 42) .......................................................F-1Consolidated Statements of Income (Loss) .........................................................................................................................F-3Consolidated Statements of Comprehensive Income (Loss) ...............................................................................................F-4Consolidated Balance Sheets ...............................................................................................................................................F-5Consolidated Statements of Shareholders’ Equity ...............................................................................................................F-6Consolidated Statements of Cash Flows ..............................................................................................................................F-7Notes to Consolidated Financial Statements ........................................................................................................................F-8(a)(2) Financial Statement Schedules have been omitted because they are either not applicable or the required information is included in the consolidated financial statements or notes thereto listed in (a)(1) above.(a)(3) Exhibits.The following is a list of exhibits filed as part of this Annual Report on Form 10-K. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. NumberGovernance Documents3.1Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended.X3.2Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.10-K(Exhibit 3.2)February 13, 2025000-19319Stock Certificate4.1Specimen Stock Certificate.10-K(Exhibit 4.1)February 15, 2018000-193194.2Description of Securities.10-K(Exhibit 4.2)February 13, 2025000-19319Collaboration Agreement10.1Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.1)November 3, 2021000-1931910.2Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.2)November 3, 2021000-1931910.3Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.10-Q/A(Exhibit 10.6)August 19, 2011000-1931910.4Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.3)November 3, 2021000-1931910.5Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.4)November 3, 2021000-19319 PART IV ITEM 15.EXHIBITS AND FINANCIAL STATEMENT SCHEDULES (a)(1) The Financial Statements required to be filed by Items 8 and 15(c) of Form 10-K, and filed herewith, are as follows: Page Number in this Form 10-KReport of Independent Registered Public Accounting Firm (PCAOB ID: 42) .......................................................F-1Consolidated Statements of Income (Loss) .........................................................................................................................F-3Consolidated Statements of Comprehensive Income (Loss) ...............................................................................................F-4Consolidated Balance Sheets ...............................................................................................................................................F-5Consolidated Statements of Shareholders’ Equity ...............................................................................................................F-6Consolidated Statements of Cash Flows ..............................................................................................................................F-7Notes to Consolidated Financial Statements ........................................................................................................................F-8 Page Number in this Form 10-KReport of Independent Registered Public Accounting Firm (PCAOB ID: 42) .......................................................F-1Consolidated Statements of Income (Loss) .........................................................................................................................F-3Consolidated Statements of Comprehensive Income (Loss) ...............................................................................................F-4Consolidated Balance Sheets ...............................................................................................................................................F-5Consolidated Statements of Shareholders’ Equity ...............................................................................................................F-6Consolidated Statements of Cash Flows ..............................................................................................................................F-7Notes to Consolidated Financial Statements ........................................................................................................................F-8 Page Number in this Form 10-KReport of Independent Registered Public Accounting Firm (PCAOB ID: 42) .......................................................F-1Consolidated Statements of Income (Loss) .........................................................................................................................F-3Consolidated Statements of Comprehensive Income (Loss) ...............................................................................................F-4Consolidated Balance Sheets ...............................................................................................................................................F-5Consolidated Statements of Shareholders’ Equity ...............................................................................................................F-6Consolidated Statements of Cash Flows ..............................................................................................................................F-7Notes to Consolidated Financial Statements ........................................................................................................................F-8"
    },
    {
      "status": "ADDED",
      "current_title": "this Form 10-K",
      "prior_title": null,
      "current_body": "Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) ....................................................... Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) ....................................................... Report of Independent Registered Public Accounting Firm (PCAOB ID: 42) ....................................................... F-1 F-1 F-1 Consolidated Statements of Income (Loss) ......................................................................................................................... Consolidated Statements of Income (Loss) ......................................................................................................................... Consolidated Statements of Income (Loss) ......................................................................................................................... F-3 F-3 F-3 Consolidated Statements of Comprehensive Income (Loss) ............................................................................................... Consolidated Statements of Comprehensive Income (Loss) ............................................................................................... Consolidated Statements of Comprehensive Income (Loss) ............................................................................................... F-4 F-4 F-4 Consolidated Balance Sheets ............................................................................................................................................... Consolidated Balance Sheets ............................................................................................................................................... Consolidated Balance Sheets ............................................................................................................................................... F-5 F-5 F-5 Consolidated Statements of Shareholders’ Equity ............................................................................................................... Consolidated Statements of Shareholders’ Equity ............................................................................................................... Consolidated Statements of Shareholders’ Equity ............................................................................................................... F-6 F-6 F-6 Consolidated Statements of Cash Flows .............................................................................................................................. Consolidated Statements of Cash Flows .............................................................................................................................. Consolidated Statements of Cash Flows .............................................................................................................................. F-7 F-7 F-7 Notes to Consolidated Financial Statements ........................................................................................................................ Notes to Consolidated Financial Statements ........................................................................................................................ Notes to Consolidated Financial Statements ........................................................................................................................ F-8 F-8 F-8 (a)(2) Financial Statement Schedules have been omitted because they are either not applicable or the required information is included in the consolidated financial statements or notes thereto listed in (a)(1) above. (a)(3) Exhibits. The following is a list of exhibits filed as part of this Annual Report on Form 10-K. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. NumberGovernance Documents3.1Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended.X3.2Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.10-K(Exhibit 3.2)February 13, 2025000-19319Stock Certificate4.1Specimen Stock Certificate.10-K(Exhibit 4.1)February 15, 2018000-193194.2Description of Securities.10-K(Exhibit 4.2)February 13, 2025000-19319Collaboration Agreement10.1Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.1)November 3, 2021000-1931910.2Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.2)November 3, 2021000-1931910.3Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.10-Q/A(Exhibit 10.6)August 19, 2011000-1931910.4Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.3)November 3, 2021000-1931910.5Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.4)November 3, 2021000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. NumberGovernance Documents3.1Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended.X3.2Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.10-K(Exhibit 3.2)February 13, 2025000-19319Stock Certificate4.1Specimen Stock Certificate.10-K(Exhibit 4.1)February 15, 2018000-193194.2Description of Securities.10-K(Exhibit 4.2)February 13, 2025000-19319Collaboration Agreement10.1Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.1)November 3, 2021000-1931910.2Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.2)November 3, 2021000-1931910.3Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.10-Q/A(Exhibit 10.6)August 19, 2011000-1931910.4Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.3)November 3, 2021000-1931910.5Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.4)November 3, 2021000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. NumberGovernance Documents3.1Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended.X3.2Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated.10-K(Exhibit 3.2)February 13, 2025000-19319Stock Certificate4.1Specimen Stock Certificate.10-K(Exhibit 4.1)February 15, 2018000-193194.2Description of Securities.10-K(Exhibit 4.2)February 13, 2025000-19319Collaboration Agreement10.1Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.1)November 3, 2021000-1931910.2Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.2)November 3, 2021000-1931910.3Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.10-Q/A(Exhibit 10.6)August 19, 2011000-1931910.4Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.3)November 3, 2021000-1931910.5Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.†10-Q(Exhibit 10.4)November 3, 2021000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Governance Documents",
      "prior_title": null,
      "current_body": "3.1 3.1 3.1 Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended. Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended. Restated Articles of Organization of Vertex Pharmaceuticals Incorporated, as amended. X X X 3.2 3.2 3.2 Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated. Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated. Amended and Restated By-Laws of Vertex Pharmaceuticals Incorporated. 10-K(Exhibit 3.2) 10-K(Exhibit 3.2) 10-K (Exhibit 3.2) February 13, 2025 February 13, 2025 February 13, 2025 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Stock Certificate",
      "prior_title": null,
      "current_body": "4.1 4.1 4.1 Specimen Stock Certificate. Specimen Stock Certificate. Specimen Stock Certificate. 10-K(Exhibit 4.1) 10-K(Exhibit 4.1) 10-K (Exhibit 4.1) February 15, 2018 February 15, 2018 February 15, 2018 000-19319 000-19319 000-19319 4.2 4.2 4.2 Description of Securities. Description of Securities. Description of Securities. 10-K(Exhibit 4.2) 10-K(Exhibit 4.2) 10-K (Exhibit 4.2) February 13, 2025 February 13, 2025 February 13, 2025 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Collaboration Agreement",
      "prior_title": null,
      "current_body": "10.1 10.1 10.1 Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Research, Development and Commercialization Agreement, dated as of May 24, 2004, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) November 3, 2021 November 3, 2021 November 3, 2021 000-19319 000-19319 000-19319 10.2 10.2 10.2 Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 1 to Research, Development and Commercialization Agreement, dated as of January 6, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) November 3, 2021 November 3, 2021 November 3, 2021 000-19319 000-19319 000-19319 10.3 10.3 10.3 Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated. Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated. Amendment No. 2 to Research, Development and Commercialization Agreement, dated as of March 17, 2006, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated. 10-Q/A(Exhibit 10.6) 10-Q/A(Exhibit 10.6) 10-Q/A (Exhibit 10.6) August 19, 2011 August 19, 2011 August 19, 2011 000-19319 000-19319 000-19319 10.4 10.4 10.4 Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 5 to Research, Development and Commercialization Agreement, effective as of April 1, 2011, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† 10-Q(Exhibit 10.3) 10-Q(Exhibit 10.3) 10-Q (Exhibit 10.3) November 3, 2021 November 3, 2021 November 3, 2021 000-19319 000-19319 000-19319 10.5 10.5 10.5 Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† Amendment No. 7 to Research, Development and Commercialization Agreement, dated October 13, 2016, between Vertex Pharmaceuticals Incorporated and Cystic Fibrosis Foundation Therapeutics Incorporated.† 10-Q(Exhibit 10.4) 10-Q(Exhibit 10.4) 10-Q (Exhibit 10.4) November 3, 2021 November 3, 2021 November 3, 2021 000-19319 000-19319 000-19319 67Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.6Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†10-Q(Exhibit 10.1)July 30, 2021000-1931910.7Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7)February 15, 2024000-19319Leases10.8Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.2)July 30, 2021000-1931910.92024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †10-Q(Exhibit 10.1)November 5, 2024000-1931910.10Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.3)July 30, 2021000-1931910.112024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†10-Q(Exhibit 10.2)November 5, 2024000-19319Financing Agreements10.12Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto.10-Q(Exhibit 10.1)August 5, 2022000-1931910.13First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A.10-Q(Exhibit 10.1)August 2, 2024000-19319Equity Plans10.14Amended and Restated 2006 Stock and Option Plan.*10-Q(Exhibit 10.1)October 25, 2018000-1931910.15Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).*10-K(Exhibit 10.20)February 13, 2015000-1931910.16Amended and Restated 2013 Stock and Option Plan.*DEF 14A(Appendix A)April 7, 2022000-1931910.17Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2015000-1931910.18Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).*10-K(Exhibit 10.25)February 16, 2016000-1931910.19Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).*10-K(Exhibit 10.19)February 13, 2015000-1931910.20Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2020000-1931910.21Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).*10-K(Exhibit 10.21)February 13, 2025000-1931910.22Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.*10-K(Exhibit 10.22)February 13, 2025000-1931910.23Non-Employee Director Deferred Compensation Plan.*10-K(Exhibit 10.27)February 16, 2016000-1931910.24Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*DEF 14A(Appendix B)April 26, 2019000-19319Agreements with Executive Officers and Directors10.25Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.*8-K(Exhibit 10.1)April 1, 2020000-1931910.26Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.*10-K(Exhibit 10.24)February 9, 2022000-1931910.27Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023*10-K(Exhibit 10.23)February 10, 2023000-19319 67 67 67 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.6Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†10-Q(Exhibit 10.1)July 30, 2021000-1931910.7Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7)February 15, 2024000-19319Leases10.8Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.2)July 30, 2021000-1931910.92024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †10-Q(Exhibit 10.1)November 5, 2024000-1931910.10Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.3)July 30, 2021000-1931910.112024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†10-Q(Exhibit 10.2)November 5, 2024000-19319Financing Agreements10.12Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto.10-Q(Exhibit 10.1)August 5, 2022000-1931910.13First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A.10-Q(Exhibit 10.1)August 2, 2024000-19319Equity Plans10.14Amended and Restated 2006 Stock and Option Plan.*10-Q(Exhibit 10.1)October 25, 2018000-1931910.15Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).*10-K(Exhibit 10.20)February 13, 2015000-1931910.16Amended and Restated 2013 Stock and Option Plan.*DEF 14A(Appendix A)April 7, 2022000-1931910.17Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2015000-1931910.18Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).*10-K(Exhibit 10.25)February 16, 2016000-1931910.19Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).*10-K(Exhibit 10.19)February 13, 2015000-1931910.20Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2020000-1931910.21Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).*10-K(Exhibit 10.21)February 13, 2025000-1931910.22Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.*10-K(Exhibit 10.22)February 13, 2025000-1931910.23Non-Employee Director Deferred Compensation Plan.*10-K(Exhibit 10.27)February 16, 2016000-1931910.24Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*DEF 14A(Appendix B)April 26, 2019000-19319Agreements with Executive Officers and Directors10.25Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.*8-K(Exhibit 10.1)April 1, 2020000-1931910.26Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.*10-K(Exhibit 10.24)February 9, 2022000-1931910.27Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023*10-K(Exhibit 10.23)February 10, 2023000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.6Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†10-Q(Exhibit 10.1)July 30, 2021000-1931910.7Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7)February 15, 2024000-19319Leases10.8Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.2)July 30, 2021000-1931910.92024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †10-Q(Exhibit 10.1)November 5, 2024000-1931910.10Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.3)July 30, 2021000-1931910.112024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†10-Q(Exhibit 10.2)November 5, 2024000-19319Financing Agreements10.12Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto.10-Q(Exhibit 10.1)August 5, 2022000-1931910.13First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A.10-Q(Exhibit 10.1)August 2, 2024000-19319Equity Plans10.14Amended and Restated 2006 Stock and Option Plan.*10-Q(Exhibit 10.1)October 25, 2018000-1931910.15Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).*10-K(Exhibit 10.20)February 13, 2015000-1931910.16Amended and Restated 2013 Stock and Option Plan.*DEF 14A(Appendix A)April 7, 2022000-1931910.17Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2015000-1931910.18Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).*10-K(Exhibit 10.25)February 16, 2016000-1931910.19Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).*10-K(Exhibit 10.19)February 13, 2015000-1931910.20Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2020000-1931910.21Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).*10-K(Exhibit 10.21)February 13, 2025000-1931910.22Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.*10-K(Exhibit 10.22)February 13, 2025000-1931910.23Non-Employee Director Deferred Compensation Plan.*10-K(Exhibit 10.27)February 16, 2016000-1931910.24Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*DEF 14A(Appendix B)April 26, 2019000-19319Agreements with Executive Officers and Directors10.25Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.*8-K(Exhibit 10.1)April 1, 2020000-1931910.26Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.*10-K(Exhibit 10.24)February 9, 2022000-1931910.27Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023*10-K(Exhibit 10.23)February 10, 2023000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.6Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†10-Q(Exhibit 10.1)July 30, 2021000-1931910.7Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7)February 15, 2024000-19319Leases10.8Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.2)July 30, 2021000-1931910.92024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †10-Q(Exhibit 10.1)November 5, 2024000-1931910.10Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.3)July 30, 2021000-1931910.112024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†10-Q(Exhibit 10.2)November 5, 2024000-19319Financing Agreements10.12Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto.10-Q(Exhibit 10.1)August 5, 2022000-1931910.13First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A.10-Q(Exhibit 10.1)August 2, 2024000-19319Equity Plans10.14Amended and Restated 2006 Stock and Option Plan.*10-Q(Exhibit 10.1)October 25, 2018000-1931910.15Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).*10-K(Exhibit 10.20)February 13, 2015000-1931910.16Amended and Restated 2013 Stock and Option Plan.*DEF 14A(Appendix A)April 7, 2022000-1931910.17Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2015000-1931910.18Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).*10-K(Exhibit 10.25)February 16, 2016000-1931910.19Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).*10-K(Exhibit 10.19)February 13, 2015000-1931910.20Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2020000-1931910.21Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).*10-K(Exhibit 10.21)February 13, 2025000-1931910.22Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.*10-K(Exhibit 10.22)February 13, 2025000-1931910.23Non-Employee Director Deferred Compensation Plan.*10-K(Exhibit 10.27)February 16, 2016000-1931910.24Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*DEF 14A(Appendix B)April 26, 2019000-19319Agreements with Executive Officers and Directors10.25Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.*8-K(Exhibit 10.1)April 1, 2020000-1931910.26Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.*10-K(Exhibit 10.24)February 9, 2022000-1931910.27Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023*10-K(Exhibit 10.23)February 10, 2023000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.6Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.†10-Q(Exhibit 10.1)July 30, 2021000-1931910.7Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7)February 15, 2024000-19319Leases10.8Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.2)July 30, 2021000-1931910.92024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. †10-Q(Exhibit 10.1)November 5, 2024000-1931910.10Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.†10-Q(Exhibit 10.3)July 30, 2021000-1931910.112024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.†10-Q(Exhibit 10.2)November 5, 2024000-19319Financing Agreements10.12Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto.10-Q(Exhibit 10.1)August 5, 2022000-1931910.13First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A.10-Q(Exhibit 10.1)August 2, 2024000-19319Equity Plans10.14Amended and Restated 2006 Stock and Option Plan.*10-Q(Exhibit 10.1)October 25, 2018000-1931910.15Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).*10-K(Exhibit 10.20)February 13, 2015000-1931910.16Amended and Restated 2013 Stock and Option Plan.*DEF 14A(Appendix A)April 7, 2022000-1931910.17Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2015000-1931910.18Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).*10-K(Exhibit 10.25)February 16, 2016000-1931910.19Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).*10-K(Exhibit 10.19)February 13, 2015000-1931910.20Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.*10-K(Exhibit 10.17)February 13, 2020000-1931910.21Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).*10-K(Exhibit 10.21)February 13, 2025000-1931910.22Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.*10-K(Exhibit 10.22)February 13, 2025000-1931910.23Non-Employee Director Deferred Compensation Plan.*10-K(Exhibit 10.27)February 16, 2016000-1931910.24Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.*DEF 14A(Appendix B)April 26, 2019000-19319Agreements with Executive Officers and Directors10.25Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.*8-K(Exhibit 10.1)April 1, 2020000-1931910.26Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.*10-K(Exhibit 10.24)February 9, 2022000-1931910.27Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023*10-K(Exhibit 10.23)February 10, 2023000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "SEC File/Reg. Number",
      "prior_title": null,
      "current_body": "SEC File/ Reg. Number 10.6 10.6 10.6 Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.7 10.7 10.7 Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7) 10-K(Exhibit 10.7) 10-K (Exhibit 10.7) February 15, 2024 February 15, 2024 February 15, 2024 000-19319 000-19319 000-19319 Leases Leases Leases 10.8 10.8 10.8 Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.9 10.9 10.9 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319 10.10 10.10 10.10 Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.3) 10-Q(Exhibit 10.3) 10-Q (Exhibit 10.3) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.11 10.11 10.11 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Financing Agreements",
      "prior_title": null,
      "current_body": "10.12 10.12 10.12 Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto. Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto. Credit Agreement, dated as of July 1, 2022, by and among Vertex Pharmaceuticals Incorporated, Bank of America, N.A. and the other lenders party thereto. 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) August 5, 2022 August 5, 2022 August 5, 2022 000-19319 000-19319 000-19319 10.13 10.13 10.13 First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A. First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A. First Amendment to Credit Agreement, dated June 20, 2024 by and between Vertex Pharmaceuticals Incorporated and Bank of America N.A. 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) August 2, 2024 August 2, 2024 August 2, 2024 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Equity Plans",
      "prior_title": null,
      "current_body": "10.14 10.14 10.14 Amended and Restated 2006 Stock and Option Plan.* Amended and Restated 2006 Stock and Option Plan.* Amended and Restated 2006 Stock and Option Plan.* 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) October 25, 2018 October 25, 2018 October 25, 2018 000-19319 000-19319 000-19319 10.15 10.15 10.15 Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).* Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).* Form of Stock Option Agreement under Amended and Restated 2006 Stock and Option Plan (granted on or after July 30, 2013).* 10-K(Exhibit 10.20) 10-K(Exhibit 10.20) 10-K (Exhibit 10.20) February 13, 2015 February 13, 2015 February 13, 2015 000-19319 000-19319 000-19319 10.16 10.16 10.16 Amended and Restated 2013 Stock and Option Plan.* Amended and Restated 2013 Stock and Option Plan.* Amended and Restated 2013 Stock and Option Plan.* DEF 14A(Appendix A) DEF 14A(Appendix A) DEF 14A (Appendix A) April 7, 2022 April 7, 2022 April 7, 2022 000-19319 000-19319 000-19319 10.17 10.17 10.17 Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.* Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.* Form of Non-Qualified Stock Option Agreement under 2013 Stock and Option Plan.* 10-K(Exhibit 10.17) 10-K(Exhibit 10.17) 10-K (Exhibit 10.17) February 13, 2015 February 13, 2015 February 13, 2015 000-19319 000-19319 000-19319 10.18 10.18 10.18 Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (U.S.).* 10-K(Exhibit 10.25) 10-K(Exhibit 10.25) 10-K (Exhibit 10.25) February 16, 2016 February 16, 2016 February 16, 2016 000-19319 000-19319 000-19319 10.19 10.19 10.19 Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (International).* 10-K(Exhibit 10.19) 10-K(Exhibit 10.19) 10-K (Exhibit 10.19) February 13, 2015 February 13, 2015 February 13, 2015 000-19319 000-19319 000-19319 10.20 10.20 10.20 Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.* Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.* Form of Restricted Stock Unit Agreement Under 2013 Stock and Option Plan.* 10-K(Exhibit 10.17) 10-K(Exhibit 10.17) 10-K (Exhibit 10.17) February 13, 2020 February 13, 2020 February 13, 2020 000-19319 000-19319 000-19319 10.21 10.21 10.21 Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).* Form of Restricted Stock Unit Agreement under 2013 Stock and Option Plan (granted on or after January 1, 2025).* 10-K(Exhibit 10.21) 10-K(Exhibit 10.21) 10-K (Exhibit 10.21) February 13, 2025 February 13, 2025 February 13, 2025 000-19319 000-19319 000-19319 10.22 10.22 10.22 Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.* Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.* Form of Restricted Stock Unit Agreement (with performance conditions) under 2013 Stock and Option Plan.* 10-K(Exhibit 10.22) 10-K(Exhibit 10.22) 10-K (Exhibit 10.22) February 13, 2025 February 13, 2025 February 13, 2025 000-19319 000-19319 000-19319 10.23 10.23 10.23 Non-Employee Director Deferred Compensation Plan.* Non-Employee Director Deferred Compensation Plan.* Non-Employee Director Deferred Compensation Plan.* 10-K(Exhibit 10.27) 10-K(Exhibit 10.27) 10-K (Exhibit 10.27) February 16, 2016 February 16, 2016 February 16, 2016 000-19319 000-19319 000-19319 10.24 10.24 10.24 Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.* Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.* Vertex Pharmaceuticals Incorporated Employee Stock Purchase Plan.* DEF 14A(Appendix B) DEF 14A(Appendix B) DEF 14A (Appendix B) April 26, 2019 April 26, 2019 April 26, 2019 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Agreements with Executive Officers and Directors",
      "prior_title": null,
      "current_body": "10.25 10.25 10.25 Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.* Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.* Employment Agreement, dated as of April 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Jeffrey M. Leiden, M.D., Ph.D.* 8-K(Exhibit 10.1) 8-K(Exhibit 10.1) 8-K (Exhibit 10.1) April 1, 2020 April 1, 2020 April 1, 2020 000-19319 000-19319 000-19319 10.26 10.26 10.26 Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.* Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.* Amendment No. 1 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 7, 2022.* 10-K(Exhibit 10.24) 10-K(Exhibit 10.24) 10-K (Exhibit 10.24) February 9, 2022 February 9, 2022 February 9, 2022 000-19319 000-19319 000-19319 10.27 10.27 10.27 Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023* Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023* Amendment No. 2 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of February 8, 2023* 10-K(Exhibit 10.23) 10-K(Exhibit 10.23) 10-K (Exhibit 10.23) February 10, 2023 February 10, 2023 February 10, 2023 000-19319 000-19319 000-19319 68Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.28Amendment No.3 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of November 1, 2024.*10-Q(Exhibit 10.3)November 5, 2024000-1931910.29Employee Non-disclosure, Non-competition and Inventions Agreement between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated December 14, 2011.*10-K(Exhibit 10.35)February 22, 2012000-1931910.30Employment Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.1)July 25, 2019000-1931910.31Change of Control Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.2)July 25, 2019000-1931910.32Employment Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.1)November 6, 2012000-1931910.33Change of Control Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.2)November 6, 2012000-1931910.34Employment Agreement, dated as of December 12, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.34)February 16, 2016000-1931910.35Change of Control Agreement, dated as of December 10, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.35)February 16, 2016000-1931910.36Third Amended and Restated Employment Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.42)February 23, 2017000-1931910.37Third Amended and Restated Change of Control Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.43)February 23, 2017000-1931910.38Employment Agreement, dated February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-Q(Exhibit 10.1)May 6, 2025000-1931910.39Change of Control Agreement, dated as of February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-K(Exhibit 10.39)February 13, 2025000-1931910.40Employment Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.36)February 9, 2022000-1931910.41Change of Control Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.37)February 9, 2022000-1931910.42Employment Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.43Change of Control Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.44Vertex Pharmaceuticals Employee Compensation Plan.*X10.45Vertex Pharmaceuticals Non-Employee Board Compensation.*10-K(Exhibit 10.43)February 13, 2025000-19319Insider Trading Policy19.1Vertex Pharmaceuticals Incorporated Insider Trading Policy. *10-K(Exhibit 19.1)February 13, 2025000-19319Subsidiaries21.1Subsidiaries of Vertex Pharmaceuticals Incorporated.XConsent23.1Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP.XCertifications31.1Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X31.2Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X32.1Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.XClawback Policy97.1Policy Relating to Recovery of Erroneously Awarded Compensation10-K(Exhibit 97.1)February 15, 2024000-19319 68 68 68 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.28Amendment No.3 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of November 1, 2024.*10-Q(Exhibit 10.3)November 5, 2024000-1931910.29Employee Non-disclosure, Non-competition and Inventions Agreement between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated December 14, 2011.*10-K(Exhibit 10.35)February 22, 2012000-1931910.30Employment Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.1)July 25, 2019000-1931910.31Change of Control Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.2)July 25, 2019000-1931910.32Employment Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.1)November 6, 2012000-1931910.33Change of Control Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.2)November 6, 2012000-1931910.34Employment Agreement, dated as of December 12, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.34)February 16, 2016000-1931910.35Change of Control Agreement, dated as of December 10, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.35)February 16, 2016000-1931910.36Third Amended and Restated Employment Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.42)February 23, 2017000-1931910.37Third Amended and Restated Change of Control Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.43)February 23, 2017000-1931910.38Employment Agreement, dated February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-Q(Exhibit 10.1)May 6, 2025000-1931910.39Change of Control Agreement, dated as of February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-K(Exhibit 10.39)February 13, 2025000-1931910.40Employment Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.36)February 9, 2022000-1931910.41Change of Control Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.37)February 9, 2022000-1931910.42Employment Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.43Change of Control Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.44Vertex Pharmaceuticals Employee Compensation Plan.*X10.45Vertex Pharmaceuticals Non-Employee Board Compensation.*10-K(Exhibit 10.43)February 13, 2025000-19319Insider Trading Policy19.1Vertex Pharmaceuticals Incorporated Insider Trading Policy. *10-K(Exhibit 19.1)February 13, 2025000-19319Subsidiaries21.1Subsidiaries of Vertex Pharmaceuticals Incorporated.XConsent23.1Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP.XCertifications31.1Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X31.2Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X32.1Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.XClawback Policy97.1Policy Relating to Recovery of Erroneously Awarded Compensation10-K(Exhibit 97.1)February 15, 2024000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.28Amendment No.3 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of November 1, 2024.*10-Q(Exhibit 10.3)November 5, 2024000-1931910.29Employee Non-disclosure, Non-competition and Inventions Agreement between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated December 14, 2011.*10-K(Exhibit 10.35)February 22, 2012000-1931910.30Employment Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.1)July 25, 2019000-1931910.31Change of Control Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.2)July 25, 2019000-1931910.32Employment Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.1)November 6, 2012000-1931910.33Change of Control Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.2)November 6, 2012000-1931910.34Employment Agreement, dated as of December 12, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.34)February 16, 2016000-1931910.35Change of Control Agreement, dated as of December 10, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.35)February 16, 2016000-1931910.36Third Amended and Restated Employment Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.42)February 23, 2017000-1931910.37Third Amended and Restated Change of Control Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.43)February 23, 2017000-1931910.38Employment Agreement, dated February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-Q(Exhibit 10.1)May 6, 2025000-1931910.39Change of Control Agreement, dated as of February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-K(Exhibit 10.39)February 13, 2025000-1931910.40Employment Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.36)February 9, 2022000-1931910.41Change of Control Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.37)February 9, 2022000-1931910.42Employment Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.43Change of Control Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.44Vertex Pharmaceuticals Employee Compensation Plan.*X10.45Vertex Pharmaceuticals Non-Employee Board Compensation.*10-K(Exhibit 10.43)February 13, 2025000-19319Insider Trading Policy19.1Vertex Pharmaceuticals Incorporated Insider Trading Policy. *10-K(Exhibit 19.1)February 13, 2025000-19319Subsidiaries21.1Subsidiaries of Vertex Pharmaceuticals Incorporated.XConsent23.1Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP.XCertifications31.1Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X31.2Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X32.1Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.XClawback Policy97.1Policy Relating to Recovery of Erroneously Awarded Compensation10-K(Exhibit 97.1)February 15, 2024000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.28Amendment No.3 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of November 1, 2024.*10-Q(Exhibit 10.3)November 5, 2024000-1931910.29Employee Non-disclosure, Non-competition and Inventions Agreement between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated December 14, 2011.*10-K(Exhibit 10.35)February 22, 2012000-1931910.30Employment Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.1)July 25, 2019000-1931910.31Change of Control Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.2)July 25, 2019000-1931910.32Employment Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.1)November 6, 2012000-1931910.33Change of Control Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.2)November 6, 2012000-1931910.34Employment Agreement, dated as of December 12, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.34)February 16, 2016000-1931910.35Change of Control Agreement, dated as of December 10, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.35)February 16, 2016000-1931910.36Third Amended and Restated Employment Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.42)February 23, 2017000-1931910.37Third Amended and Restated Change of Control Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.43)February 23, 2017000-1931910.38Employment Agreement, dated February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-Q(Exhibit 10.1)May 6, 2025000-1931910.39Change of Control Agreement, dated as of February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-K(Exhibit 10.39)February 13, 2025000-1931910.40Employment Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.36)February 9, 2022000-1931910.41Change of Control Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.37)February 9, 2022000-1931910.42Employment Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.43Change of Control Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.44Vertex Pharmaceuticals Employee Compensation Plan.*X10.45Vertex Pharmaceuticals Non-Employee Board Compensation.*10-K(Exhibit 10.43)February 13, 2025000-19319Insider Trading Policy19.1Vertex Pharmaceuticals Incorporated Insider Trading Policy. *10-K(Exhibit 19.1)February 13, 2025000-19319Subsidiaries21.1Subsidiaries of Vertex Pharmaceuticals Incorporated.XConsent23.1Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP.XCertifications31.1Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X31.2Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X32.1Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.XClawback Policy97.1Policy Relating to Recovery of Erroneously Awarded Compensation10-K(Exhibit 97.1)February 15, 2024000-19319 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number10.28Amendment No.3 to Employment Agreement, between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated as of November 1, 2024.*10-Q(Exhibit 10.3)November 5, 2024000-1931910.29Employee Non-disclosure, Non-competition and Inventions Agreement between Jeffrey M. Leiden and Vertex Pharmaceuticals Incorporated, dated December 14, 2011.*10-K(Exhibit 10.35)February 22, 2012000-1931910.30Employment Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.1)July 25, 2019000-1931910.31Change of Control Agreement, dated as of July 24, 2019, between Vertex Pharmaceuticals Incorporated and Reshma Kewalramani.*8-K (Exhibit 10.2)July 25, 2019000-1931910.32Employment Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.1)November 6, 2012000-1931910.33Change of Control Agreement, dated as of August 27, 2012, between Vertex Pharmaceuticals Incorporated and Stuart Arbuckle.*10-Q(Exhibit 10.2)November 6, 2012000-1931910.34Employment Agreement, dated as of December 12, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.34)February 16, 2016000-1931910.35Change of Control Agreement, dated as of December 10, 2014, between Vertex Pharmaceuticals Incorporated and David Altshuler.*10-K(Exhibit 10.35)February 16, 2016000-1931910.36Third Amended and Restated Employment Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.42)February 23, 2017000-1931910.37Third Amended and Restated Change of Control Agreement, dated as of February 26, 2013, between Vertex Pharmaceuticals Incorporated and Amit Sachdev.*10-K (Exhibit 10.43)February 23, 2017000-1931910.38Employment Agreement, dated February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-Q(Exhibit 10.1)May 6, 2025000-1931910.39Change of Control Agreement, dated as of February 7, 2025, by and between Vertex Pharmaceuticals Incorporated and Charles F. Wagner, Jr.*10-K(Exhibit 10.39)February 13, 2025000-1931910.40Employment Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.36)February 9, 2022000-1931910.41Change of Control Agreement, dated August 1, 2020, by and between Vertex Pharmaceuticals Incorporated and Nia Tatsis.*10-K(Exhibit 10.37)February 9, 2022000-1931910.42Employment Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.43Change of Control Agreement, dated October 3, 2022, by and between Vertex Pharmaceuticals Incorporated and Carmen Bozic.*X10.44Vertex Pharmaceuticals Employee Compensation Plan.*X10.45Vertex Pharmaceuticals Non-Employee Board Compensation.*10-K(Exhibit 10.43)February 13, 2025000-19319Insider Trading Policy19.1Vertex Pharmaceuticals Incorporated Insider Trading Policy. *10-K(Exhibit 19.1)February 13, 2025000-19319Subsidiaries21.1Subsidiaries of Vertex Pharmaceuticals Incorporated.XConsent23.1Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP.XCertifications31.1Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X31.2Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002.X32.1Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002.XClawback Policy97.1Policy Relating to Recovery of Erroneously Awarded Compensation10-K(Exhibit 97.1)February 15, 2024000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "SEC File/Reg. Number",
      "prior_title": null,
      "current_body": "SEC File/ Reg. Number 10.6 10.6 10.6 Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.7 10.7 10.7 Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7) 10-K(Exhibit 10.7) 10-K (Exhibit 10.7) February 15, 2024 February 15, 2024 February 15, 2024 000-19319 000-19319 000-19319 Leases Leases Leases 10.8 10.8 10.8 Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.9 10.9 10.9 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319 10.10 10.10 10.10 Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.3) 10-Q(Exhibit 10.3) 10-Q (Exhibit 10.3) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.11 10.11 10.11 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Insider Trading Policy",
      "prior_title": null,
      "current_body": "19.1 19.1 19.1 Vertex Pharmaceuticals Incorporated Insider Trading Policy. * Vertex Pharmaceuticals Incorporated Insider Trading Policy. * Vertex Pharmaceuticals Incorporated Insider Trading Policy. * 10-K(Exhibit 19.1) 10-K(Exhibit 19.1) 10-K (Exhibit 19.1) February 13, 2025 February 13, 2025 February 13, 2025 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Subsidiaries",
      "prior_title": null,
      "current_body": "21.1 21.1 21.1 Subsidiaries of Vertex Pharmaceuticals Incorporated. Subsidiaries of Vertex Pharmaceuticals Incorporated. Subsidiaries of Vertex Pharmaceuticals Incorporated. X X X Consent Consent Consent 23.1 23.1 23.1 Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP. Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP. Consent of Independent Registered Public Accounting Firm, Ernst & Young LLP. X X X"
    },
    {
      "status": "ADDED",
      "current_title": "Certifications",
      "prior_title": null,
      "current_body": "31.1 31.1 31.1 Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Executive Officer under Section 302 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Executive Officer under Section 302 of the Sarbanes- Oxley Act of 2002. X X X 31.2 31.2 31.2 Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Financial Officer under Section 302 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Financial Officer under Section 302 of the Sarbanes- Oxley Act of 2002. X X X 32.1 32.1 32.1 Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002. Certification of the Chief Executive Officer and the Chief Financial Officer under Section 906 of the Sarbanes-Oxley Act of 2002. X X X"
    },
    {
      "status": "ADDED",
      "current_title": "Clawback Policy",
      "prior_title": null,
      "current_body": "97.1 97.1 97.1 Policy Relating to Recovery of Erroneously Awarded Compensation Policy Relating to Recovery of Erroneously Awarded Compensation Policy Relating to Recovery of Erroneously Awarded Compensation 10-K(Exhibit 97.1) 10-K(Exhibit 97.1) 10-K (Exhibit 97.1) February 15, 2024 February 15, 2024 February 15, 2024 000-19319 000-19319 000-19319 69Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number101.INSXBRL InstanceX101.SCHXBRL Taxonomy Extension SchemaX101.CALXBRL Taxonomy Extension CalculationX101.LABXBRL Taxonomy Extension LabelsX101.PREXBRL Taxonomy Extension PresentationX101.DEFXBRL Taxonomy Extension DefinitionX104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.X*Management contract, compensatory plan or agreement.†Confidential portions of this document have been redacted according to the applicable rules.ITEM 16.FORM 10-K SUMMARYNot applicable. 69 69 69 Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number101.INSXBRL InstanceX101.SCHXBRL Taxonomy Extension SchemaX101.CALXBRL Taxonomy Extension CalculationX101.LABXBRL Taxonomy Extension LabelsX101.PREXBRL Taxonomy Extension PresentationX101.DEFXBRL Taxonomy Extension DefinitionX104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.X*Management contract, compensatory plan or agreement.†Confidential portions of this document have been redacted according to the applicable rules.ITEM 16.FORM 10-K SUMMARYNot applicable. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number101.INSXBRL InstanceX101.SCHXBRL Taxonomy Extension SchemaX101.CALXBRL Taxonomy Extension CalculationX101.LABXBRL Taxonomy Extension LabelsX101.PREXBRL Taxonomy Extension PresentationX101.DEFXBRL Taxonomy Extension DefinitionX104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.X*Management contract, compensatory plan or agreement.†Confidential portions of this document have been redacted according to the applicable rules. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number101.INSXBRL InstanceX101.SCHXBRL Taxonomy Extension SchemaX101.CALXBRL Taxonomy Extension CalculationX101.LABXBRL Taxonomy Extension LabelsX101.PREXBRL Taxonomy Extension PresentationX101.DEFXBRL Taxonomy Extension DefinitionX104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.X*Management contract, compensatory plan or agreement.†Confidential portions of this document have been redacted according to the applicable rules. Exhibit NumberExhibit DescriptionFiled with this reportIncorporated by Reference herein from—Form or ScheduleFiling Date/ Period CoveredSEC File/Reg. Number101.INSXBRL InstanceX101.SCHXBRL Taxonomy Extension SchemaX101.CALXBRL Taxonomy Extension CalculationX101.LABXBRL Taxonomy Extension LabelsX101.PREXBRL Taxonomy Extension PresentationX101.DEFXBRL Taxonomy Extension DefinitionX104Cover Page Interactive Data File––the cover page interactive data file does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document.X*Management contract, compensatory plan or agreement.†Confidential portions of this document have been redacted according to the applicable rules."
    },
    {
      "status": "ADDED",
      "current_title": "SEC File/Reg. Number",
      "prior_title": null,
      "current_body": "SEC File/ Reg. Number 10.6 10.6 10.6 Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amended and Restated Joint Development and Commercialization Agreement, dated April 16, 2021, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.7 10.7 10.7 Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† Amendment No. 1 to Amended and Restated Joint Development and Commercialization Agreement, dated December 12, 2023, between Vertex Pharmaceuticals Incorporated, Vertex Pharmaceuticals (Europe) Limited and CRISPR Therapeutics AG, CRISPR Therapeutics Limited, CRISPR Therapeutics, Inc., TRACR Hematology Ltd.† 10-K(Exhibit 10.7) 10-K(Exhibit 10.7) 10-K (Exhibit 10.7) February 15, 2024 February 15, 2024 February 15, 2024 000-19319 000-19319 000-19319 Leases Leases Leases 10.8 10.8 10.8 Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Fifty Northern Avenue LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.9 10.9 10.9 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 2024 Amendment to the Lease (50 Northern Avenue), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC. † 10-Q(Exhibit 10.1) 10-Q(Exhibit 10.1) 10-Q (Exhibit 10.1) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319 10.10 10.10 10.10 Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† Lease, dated May 5, 2011, between Eleven Fan Pier Boulevard LLC and Vertex Pharmaceuticals Incorporated.† 10-Q(Exhibit 10.3) 10-Q(Exhibit 10.3) 10-Q (Exhibit 10.3) July 30, 2021 July 30, 2021 July 30, 2021 000-19319 000-19319 000-19319 10.11 10.11 10.11 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 2024 Amendment to Lease (11 Fan Pier Boulevard), dated August 15, 2024, between Vertex Pharmaceuticals Incorporated and SNH Seaport LLC.† 10-Q(Exhibit 10.2) 10-Q(Exhibit 10.2) 10-Q (Exhibit 10.2) November 5, 2024 November 5, 2024 November 5, 2024 000-19319 000-19319 000-19319"
    },
    {
      "status": "ADDED",
      "current_title": "Vertex Pharmaceuticals Incorporated",
      "prior_title": null,
      "current_body": "February 13, 2026 February 13, 2026 February 13, 2026 By: By: By: /s/ Reshma Kewalramani /s/ Reshma Kewalramani /s/ Reshma Kewalramani Reshma KewalramaniChief Executive Officer Reshma KewalramaniChief Executive Officer Reshma Kewalramani Chief Executive Officer Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities and on the dates indicated. NameTitleDate/s/ Reshma KewalramaniReshma KewalramaniPresident, Chief Executive Officer and Director (Principal Executive Officer)February 13, 2026/s/ Charles F. Wagner, Jr.Charles F. Wagner, Jr.Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer)February 13, 2026/s/ Kristen C. AmbroseKristen C. AmbroseSenior Vice President and Chief Accounting Officer (Principal Accounting Officer)February 13, 2026/s/Jeffrey M. LeidenJeffrey M. LeidenExecutive ChairmanFebruary 13, 2026/s/ Sangeeta N. BhatiaSangeeta N. BhatiaDirectorFebruary 13, 2026/s/ Lloyd CarneyLloyd CarneyDirectorFebruary 13, 2026/s/ Alan GarberAlan GarberDirectorFebruary 13, 2026/s/ Michel LagardeMichel LagardeDirectorFebruary 13, 2026/s/ Diana McKenzieDiana McKenzieDirectorFebruary 13, 2026/s/ Nancy A. ThornberryNancy A. ThornberryDirectorFebruary 13, 2026/s/ Bruce I. SachsBruce I. SachsDirectorFebruary 13, 2026/s/ Jennifer SchneiderJennifer SchneiderDirectorFebruary 13, 2026/s/ Suketu UpadhyaySuketu UpadhyayDirectorFebruary 13, 2026 NameTitleDate/s/ Reshma KewalramaniReshma KewalramaniPresident, Chief Executive Officer and Director (Principal Executive Officer)February 13, 2026/s/ Charles F. Wagner, Jr.Charles F. Wagner, Jr.Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer)February 13, 2026/s/ Kristen C. AmbroseKristen C. AmbroseSenior Vice President and Chief Accounting Officer (Principal Accounting Officer)February 13, 2026/s/Jeffrey M. LeidenJeffrey M. LeidenExecutive ChairmanFebruary 13, 2026/s/ Sangeeta N. BhatiaSangeeta N. BhatiaDirectorFebruary 13, 2026/s/ Lloyd CarneyLloyd CarneyDirectorFebruary 13, 2026/s/ Alan GarberAlan GarberDirectorFebruary 13, 2026/s/ Michel LagardeMichel LagardeDirectorFebruary 13, 2026/s/ Diana McKenzieDiana McKenzieDirectorFebruary 13, 2026/s/ Nancy A. ThornberryNancy A. ThornberryDirectorFebruary 13, 2026/s/ Bruce I. SachsBruce I. SachsDirectorFebruary 13, 2026/s/ Jennifer SchneiderJennifer SchneiderDirectorFebruary 13, 2026/s/ Suketu UpadhyaySuketu UpadhyayDirectorFebruary 13, 2026 NameTitleDate/s/ Reshma KewalramaniReshma KewalramaniPresident, Chief Executive Officer and Director (Principal Executive Officer)February 13, 2026/s/ Charles F. Wagner, Jr.Charles F. Wagner, Jr.Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer)February 13, 2026/s/ Kristen C. AmbroseKristen C. AmbroseSenior Vice President and Chief Accounting Officer (Principal Accounting Officer)February 13, 2026/s/Jeffrey M. LeidenJeffrey M. LeidenExecutive ChairmanFebruary 13, 2026/s/ Sangeeta N. BhatiaSangeeta N. BhatiaDirectorFebruary 13, 2026/s/ Lloyd CarneyLloyd CarneyDirectorFebruary 13, 2026/s/ Alan GarberAlan GarberDirectorFebruary 13, 2026/s/ Michel LagardeMichel LagardeDirectorFebruary 13, 2026/s/ Diana McKenzieDiana McKenzieDirectorFebruary 13, 2026/s/ Nancy A. ThornberryNancy A. ThornberryDirectorFebruary 13, 2026/s/ Bruce I. SachsBruce I. SachsDirectorFebruary 13, 2026/s/ Jennifer SchneiderJennifer SchneiderDirectorFebruary 13, 2026/s/ Suketu UpadhyaySuketu UpadhyayDirectorFebruary 13, 2026 Name Name Name Title Title Title Date Date Date /s/ Reshma Kewalramani /s/ Reshma Kewalramani /s/ Reshma Kewalramani Reshma Kewalramani Reshma Kewalramani Reshma Kewalramani President, Chief Executive Officer and Director (Principal Executive Officer) President, Chief Executive Officer and Director (Principal Executive Officer) President, Chief Executive Officer and Director (Principal Executive Officer) February 13, 2026 February 13, 2026 February 13, 2026 /s/ Charles F. Wagner, Jr. /s/ Charles F. Wagner, Jr. /s/ Charles F. Wagner, Jr. Charles F. Wagner, Jr. Charles F. Wagner, Jr. Charles F. Wagner, Jr. Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer) Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer) Executive Vice President and Chief Operating & Financial Officer (Principal Financial Officer) February 13, 2026 February 13, 2026 February 13, 2026 /s/ Kristen C. Ambrose /s/ Kristen C. Ambrose /s/ Kristen C. Ambrose Kristen C. Ambrose Kristen C. Ambrose Kristen C. Ambrose Senior Vice President and Chief Accounting Officer (Principal Accounting Officer) Senior Vice President and Chief Accounting Officer (Principal Accounting Officer) Senior Vice President and Chief Accounting Officer (Principal Accounting Officer) February 13, 2026 February 13, 2026 February 13, 2026 /s/Jeffrey M. Leiden /s/Jeffrey M. Leiden /s/Jeffrey M. Leiden Jeffrey M. Leiden Jeffrey M. Leiden Jeffrey M. Leiden Executive Chairman Executive Chairman Executive Chairman February 13, 2026 February 13, 2026 February 13, 2026 /s/ Sangeeta N. Bhatia /s/ Sangeeta N. Bhatia /s/ Sangeeta N. Bhatia Sangeeta N. Bhatia Sangeeta N. Bhatia Sangeeta N. Bhatia Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Lloyd Carney /s/ Lloyd Carney /s/ Lloyd Carney Lloyd Carney Lloyd Carney Lloyd Carney Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Alan Garber /s/ Alan Garber /s/ Alan Garber Alan Garber Alan Garber Alan Garber Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Michel Lagarde /s/ Michel Lagarde /s/ Michel Lagarde Michel Lagarde Michel Lagarde Michel Lagarde Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Diana McKenzie /s/ Diana McKenzie /s/ Diana McKenzie Diana McKenzie Diana McKenzie Diana McKenzie Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Nancy A. Thornberry /s/ Nancy A. Thornberry /s/ Nancy A. Thornberry Nancy A. Thornberry Nancy A. Thornberry Nancy A. Thornberry Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Bruce I. Sachs /s/ Bruce I. Sachs /s/ Bruce I. Sachs Bruce I. Sachs Bruce I. Sachs Bruce I. Sachs Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Jennifer Schneider /s/ Jennifer Schneider /s/ Jennifer Schneider Jennifer Schneider Jennifer Schneider Jennifer Schneider Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 /s/ Suketu Upadhyay /s/ Suketu Upadhyay /s/ Suketu Upadhyay Suketu Upadhyay Suketu Upadhyay Suketu Upadhyay Director Director Director February 13, 2026 February 13, 2026 February 13, 2026 F-1Report of Independent Registered Public Accounting FirmTo the Shareholders and the Board of Directors of Vertex Pharmaceuticals IncorporatedOpinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Vertex Pharmaceuticals Incorporated (the Company) as of December 31, 2025 and 2024, the related consolidated statements of income (loss), comprehensive income (loss), shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 13, 2026 expressed an unqualified opinion thereon.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.Critical Audit MatterThe critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. F-1 F-1 F-1 Report of Independent Registered Public Accounting FirmTo the Shareholders and the Board of Directors of Vertex Pharmaceuticals IncorporatedOpinion on the Financial StatementsWe have audited the accompanying consolidated balance sheets of Vertex Pharmaceuticals Incorporated (the Company) as of December 31, 2025 and 2024, the related consolidated statements of income (loss), comprehensive income (loss), shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 13, 2026 expressed an unqualified opinion thereon.Basis for OpinionThese financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s financial statements based on our audits. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. Our audits included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audits provide a reasonable basis for our opinion.Critical Audit MatterThe critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates."
    },
    {
      "status": "ADDED",
      "current_title": "Report of Independent Registered Public Accounting Firm",
      "prior_title": null,
      "current_body": "To the Shareholders and the Board of Directors of Vertex Pharmaceuticals Incorporated"
    },
    {
      "status": "ADDED",
      "current_title": "Opinion on the Financial Statements",
      "prior_title": null,
      "current_body": "We have audited the accompanying consolidated balance sheets of Vertex Pharmaceuticals Incorporated (the Company) as of December 31, 2025 and 2024, the related consolidated statements of income (loss), comprehensive income (loss), shareholders’ equity and cash flows for each of the three years in the period ended December 31, 2025, and the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company at December 31, 2025 and 2024, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2025, in conformity with U.S. generally accepted accounting principles. We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States) (PCAOB), the Company’s internal control over financial reporting as of December 31, 2025, based on criteria established in Internal Control—Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (2013 framework), and our report dated February 13, 2026 expressed an unqualified opinion thereon."
    },
    {
      "status": "ADDED",
      "current_title": "Basis for Opinion",
      "prior_title": null,
      "current_body": "The Company’s management is responsible for maintaining effective internal control over financial reporting and for its assessment of the effectiveness of internal control over financial reporting included in the accompanying Management’s Annual Report on Internal Control Over Financial Reporting. Our responsibility is to express an opinion on the Company’s internal control over financial reporting based on our audit. We are a public accounting firm registered with the PCAOB and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary in the circumstances. We believe that our audit provides a reasonable basis for our opinion."
    },
    {
      "status": "ADDED",
      "current_title": "Critical Audit Matter",
      "prior_title": null,
      "current_body": "The critical audit matter communicated below is a matter arising from the current period audit of the financial statements that was communicated or required to be communicated to the audit committee and that: (1) relates to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective or complex judgments. The communication of the critical audit matter does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates. F-2Medicaid Drug Rebate Program in the U.S.Description of the MatterAs discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. /s/ Ernst & Young LLPWe have served as the Company’s auditor since 2005.Boston, MassachusettsFebruary 13, 2026 F-2 F-2 F-2 Medicaid Drug Rebate Program in the U.S.Description of the MatterAs discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. /s/ Ernst & Young LLPWe have served as the Company’s auditor since 2005.Boston, MassachusettsFebruary 13, 2026 Medicaid Drug Rebate Program in the U.S.Description of the MatterAs discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. Medicaid Drug Rebate Program in the U.S.Description of the MatterAs discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. Medicaid Drug Rebate Program in the U.S.Description of the MatterAs discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our AuditWe obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates."
    },
    {
      "status": "ADDED",
      "current_title": "Medicaid Drug Rebate Program in the U.S.",
      "prior_title": null,
      "current_body": "Description of the Matter Description of the Matter Description of the Matter As discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. As discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. As discussed in Note A to the Company’s consolidated financial statements, the Company recognizes revenue from product sales based on amounts due from customers net of allowances for variable consideration, which include, among others, rebates mandated by law under Medicaid and other government pricing programs. The most significant estimates relate to government and private payor rebates, chargebacks, discounts and fees, collectively rebates. The Company includes an estimate of variable consideration in its transaction price at the time of sale, when control of the product transfers to the customer. The Company estimates its Medicaid and other government pricing accruals based on monthly sales, historical experience of claims submitted by the various states and jurisdictions, historical rebate rates and estimated lag time of the rebate invoices. Rebate accruals inclusive of estimated amounts due for claims not yet received or processed as part of the Company’s Medicaid program are recorded within accrued expenses on the Company’s consolidated balance sheet. Auditing the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. was complex and judgmental due to the significant estimation required in determining certain assumptions including the levels of expected utilization of these rebates based on the amount of product sold to eligible patients, as well as the complexity of the government mandated rebate calculations. The allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S. are sensitive to these significant assumptions and calculations. How We Addressed the Matter in Our Audit How We Addressed the Matter in Our Audit How We Addressed the Matter in Our Audit We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations.Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. We obtained an understanding, evaluated the design and tested the operating effectiveness of controls over the Company’s revenue recognition process, including controls over management’s computation and review of the allowances for Medicaid rebates. We tested the Company’s controls to assess the completeness and accuracy of the current and historical data that supports the Medicaid estimate, significant assumptions related to the inputs utilized as well as management’s review of the application of the government pricing regulations. Our audit procedures to test the allowances for rebates owed pursuant to the Medicaid Drug Rebate Program in the U.S., included the following: we assessed the methodology used to determine the estimate and tested the significant assumptions as well as the underlying data used by the Company in its analysis. We also assessed the historical accuracy of the Company’s estimates of Medicaid rebates by comparing assumptions to historical trends and evaluating the change from prior periods. We further tested the completeness and accuracy of the underlying data used in the Company’s calculations through reconciliation to third-party invoices, claims data and actual cash payments. In addition, we involved our government pricing specialists to assist in evaluating management’s methodology and calculations used in the measurement of certain estimated rebates. /s/ Ernst & Young LLP We have served as the Company’s auditor since 2005. Boston, Massachusetts February 13, 2026 F-3VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Income (Loss)(in millions, except per share amounts)Year Ended December 31,202520242023Revenues:Product revenues, net$11,970.6$11,020.1$9,869.2Other revenues30.7——Total revenues12,001.311,020.19,869.2Costs and expenses:Cost of sales1,651.31,530.51,262.2Research and development expenses3,909.53,630.33,162.9Acquired in-process research and development expenses133.04,628.4527.1Selling, general and administrative expenses1,753.11,464.31,136.6Intangible asset impairment charge379.0——Change in fair value of contingent consideration2.1(0.5)(51.6)Total costs and expenses7,828.011,253.06,037.2Income (loss) from operations4,173.3(232.9)3,832.0Interest income490.9598.1614.7Interest expense(13.3)(30.6)(44.1)Other expense, net(7.7)(86.1)(22.8)Income before provision for income taxes4,643.2248.54,379.8Provision for income taxes690.0784.1760.2Net income (loss)$3,953.2$(535.6)$3,619.6Net income (loss) per common share:Basic$15.46$(2.08)$14.05Diluted$15.32$(2.08)$13.89Shares used in per share calculations:Basic255.7257.9257.7Diluted258.0257.9260.5The accompanying notes are an integral part of these consolidated financial statements. F-3 F-3 F-3 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Income (Loss)(in millions, except per share amounts)Year Ended December 31,202520242023Revenues:Product revenues, net$11,970.6$11,020.1$9,869.2Other revenues30.7——Total revenues12,001.311,020.19,869.2Costs and expenses:Cost of sales1,651.31,530.51,262.2Research and development expenses3,909.53,630.33,162.9Acquired in-process research and development expenses133.04,628.4527.1Selling, general and administrative expenses1,753.11,464.31,136.6Intangible asset impairment charge379.0——Change in fair value of contingent consideration2.1(0.5)(51.6)Total costs and expenses7,828.011,253.06,037.2Income (loss) from operations4,173.3(232.9)3,832.0Interest income490.9598.1614.7Interest expense(13.3)(30.6)(44.1)Other expense, net(7.7)(86.1)(22.8)Income before provision for income taxes4,643.2248.54,379.8Provision for income taxes690.0784.1760.2Net income (loss)$3,953.2$(535.6)$3,619.6Net income (loss) per common share:Basic$15.46$(2.08)$14.05Diluted$15.32$(2.08)$13.89Shares used in per share calculations:Basic255.7257.9257.7Diluted258.0257.9260.5The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except per share amounts)",
      "prior_title": null,
      "current_body": "Year Ended December 31,202520242023Revenues:Product revenues, net$11,970.6$11,020.1$9,869.2Other revenues30.7——Total revenues12,001.311,020.19,869.2Costs and expenses:Cost of sales1,651.31,530.51,262.2Research and development expenses3,909.53,630.33,162.9Acquired in-process research and development expenses133.04,628.4527.1Selling, general and administrative expenses1,753.11,464.31,136.6Intangible asset impairment charge379.0——Change in fair value of contingent consideration2.1(0.5)(51.6)Total costs and expenses7,828.011,253.06,037.2Income (loss) from operations4,173.3(232.9)3,832.0Interest income490.9598.1614.7Interest expense(13.3)(30.6)(44.1)Other expense, net(7.7)(86.1)(22.8)Income before provision for income taxes4,643.2248.54,379.8Provision for income taxes690.0784.1760.2Net income (loss)$3,953.2$(535.6)$3,619.6Net income (loss) per common share:Basic$15.46$(2.08)$14.05Diluted$15.32$(2.08)$13.89Shares used in per share calculations:Basic255.7257.9257.7Diluted258.0257.9260.5 Year Ended December 31,202520242023Revenues:Product revenues, net$11,970.6$11,020.1$9,869.2Other revenues30.7——Total revenues12,001.311,020.19,869.2Costs and expenses:Cost of sales1,651.31,530.51,262.2Research and development expenses3,909.53,630.33,162.9Acquired in-process research and development expenses133.04,628.4527.1Selling, general and administrative expenses1,753.11,464.31,136.6Intangible asset impairment charge379.0——Change in fair value of contingent consideration2.1(0.5)(51.6)Total costs and expenses7,828.011,253.06,037.2Income (loss) from operations4,173.3(232.9)3,832.0Interest income490.9598.1614.7Interest expense(13.3)(30.6)(44.1)Other expense, net(7.7)(86.1)(22.8)Income before provision for income taxes4,643.2248.54,379.8Provision for income taxes690.0784.1760.2Net income (loss)$3,953.2$(535.6)$3,619.6Net income (loss) per common share:Basic$15.46$(2.08)$14.05Diluted$15.32$(2.08)$13.89Shares used in per share calculations:Basic255.7257.9257.7Diluted258.0257.9260.5 Year Ended December 31,202520242023Revenues:Product revenues, net$11,970.6$11,020.1$9,869.2Other revenues30.7——Total revenues12,001.311,020.19,869.2Costs and expenses:Cost of sales1,651.31,530.51,262.2Research and development expenses3,909.53,630.33,162.9Acquired in-process research and development expenses133.04,628.4527.1Selling, general and administrative expenses1,753.11,464.31,136.6Intangible asset impairment charge379.0——Change in fair value of contingent consideration2.1(0.5)(51.6)Total costs and expenses7,828.011,253.06,037.2Income (loss) from operations4,173.3(232.9)3,832.0Interest income490.9598.1614.7Interest expense(13.3)(30.6)(44.1)Other expense, net(7.7)(86.1)(22.8)Income before provision for income taxes4,643.2248.54,379.8Provision for income taxes690.0784.1760.2Net income (loss)$3,953.2$(535.6)$3,619.6Net income (loss) per common share:Basic$15.46$(2.08)$14.05Diluted$15.32$(2.08)$13.89Shares used in per share calculations:Basic255.7257.9257.7Diluted258.0257.9260.5"
    },
    {
      "status": "ADDED",
      "current_title": "Year Ended December 31,",
      "prior_title": null,
      "current_body": "2025 2025 2025 2024 2024 2024 2023 2023 2023 Revenues: Revenues: Revenues: Product revenues, net Product revenues, net Product revenues, net $11,970.6 $11,970.6 $11,970.6 $ 11,970.6 $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 — — — — — — — — Total revenues Total revenues Total revenues 12,001.3 12,001.3 12,001.3 12,001.3 11,020.1 11,020.1 11,020.1 11,020.1 9,869.2 9,869.2 9,869.2 9,869.2 Costs and expenses: Costs and expenses: Costs and expenses: Cost of sales Cost of sales Cost of sales 1,651.3 1,651.3 1,651.3 1,651.3 1,530.5 1,530.5 1,530.5 1,530.5 1,262.2 1,262.2 1,262.2 1,262.2 Research and development expenses Research and development expenses Research and development expenses Research and development expenses 3,909.5 3,909.5 3,909.5 3,909.5 3,630.3 3,630.3 3,630.3 3,630.3 3,162.9 3,162.9 3,162.9 3,162.9 Acquired in-process research and development expenses Acquired in-process research and development expenses Acquired in-process research and development expenses 133.0 133.0 133.0 133.0 4,628.4 4,628.4 4,628.4 4,628.4 527.1 527.1 527.1 527.1 Selling, general and administrative expenses Selling, general and administrative expenses Selling, general and administrative expenses 1,753.1 1,753.1 1,753.1 1,753.1 1,464.3 1,464.3 1,464.3 1,464.3 1,136.6 1,136.6 1,136.6 1,136.6 Intangible asset impairment charge Intangible asset impairment charge Intangible asset impairment charge 379.0 379.0 379.0 379.0 — — — — — — — — Change in fair value of contingent consideration Change in fair value of contingent consideration Change in fair value of contingent consideration 2.1 2.1 2.1 2.1 (0.5) (0.5) (0.5) (0.5) (51.6) (51.6) (51.6) (51.6) Total costs and expenses Total costs and expenses Total costs and expenses 7,828.0 7,828.0 7,828.0 7,828.0 11,253.0 11,253.0 11,253.0 11,253.0 6,037.2 6,037.2 6,037.2 6,037.2 Income (loss) from operations Income (loss) from operations Income (loss) from operations 4,173.3 4,173.3 4,173.3 4,173.3 (232.9) (232.9) (232.9) (232.9) 3,832.0 3,832.0 3,832.0 3,832.0 Interest income Interest income Interest income 490.9 490.9 490.9 490.9 598.1 598.1 598.1 598.1 614.7 614.7 614.7 614.7 Interest expense Interest expense Interest expense (13.3) (13.3) (13.3) (13.3) (30.6) (30.6) (30.6) (30.6) (44.1) (44.1) (44.1) (44.1) Other expense, net Other expense, net Other expense, net (7.7) (7.7) (7.7) (7.7) (86.1) (86.1) (86.1) (86.1) (22.8) (22.8) (22.8) (22.8) Income before provision for income taxes Income before provision for income taxes Income before provision for income taxes 4,643.2 4,643.2 4,643.2 4,643.2 248.5 248.5 248.5 248.5 4,379.8 4,379.8 4,379.8 4,379.8 Provision for income taxes Provision for income taxes Provision for income taxes 690.0 690.0 690.0 690.0 784.1 784.1 784.1 784.1 760.2 760.2 760.2 760.2 Net income (loss) Net income (loss) Net income (loss) $3,953.2 $3,953.2 $3,953.2 $ 3,953.2 $(535.6) $(535.6) $(535.6) $ (535.6) $3,619.6 $3,619.6 $3,619.6 $ 3,619.6 Net income (loss) per common share: Net income (loss) per common share: Net income (loss) per common share: Basic Basic Basic $15.46 $15.46 $15.46 $ 15.46 $(2.08) $(2.08) $(2.08) $ (2.08) $14.05 $14.05 $14.05 $ 14.05 Diluted Diluted Diluted $15.32 $15.32 $15.32 $ 15.32 $(2.08) $(2.08) $(2.08) $ (2.08) $13.89 $13.89 $13.89 $ 13.89 Shares used in per share calculations: Shares used in per share calculations: Shares used in per share calculations: Basic Basic Basic 255.7 255.7 255.7 255.7 257.9 257.9 257.9 257.9 257.7 257.7 257.7 257.7 Diluted Diluted Diluted 258.0 258.0 258.0 258.0 257.9 257.9 257.9 257.9 260.5 260.5 260.5 260.5 The accompanying notes are an integral part of these consolidated financial statements. F-4VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Comprehensive Income (Loss)(in millions)Year ended December 31,202520242023Net income (loss)$3,953.2$(535.6)$3,619.6Other comprehensive (loss) income:Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively26.9(2.5)9.7Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively(198.1)136.0(50.9)Foreign currency translation adjustment27.58.626.1Total other comprehensive (loss) income(143.7)142.1(15.1)Comprehensive income (loss)$3,809.5$(393.5)$3,604.5The accompanying notes are an integral part of these consolidated financial statements. F-4 F-4 F-4 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Comprehensive Income (Loss)(in millions)Year ended December 31,202520242023Net income (loss)$3,953.2$(535.6)$3,619.6Other comprehensive (loss) income:Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively26.9(2.5)9.7Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively(198.1)136.0(50.9)Foreign currency translation adjustment27.58.626.1Total other comprehensive (loss) income(143.7)142.1(15.1)Comprehensive income (loss)$3,809.5$(393.5)$3,604.5The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "(in millions)",
      "prior_title": null,
      "current_body": "Net cash provided by (used in): Net cash provided by (used in): Net cash provided by (used in): Operating activities Operating activities Operating activities $3,631.4 $3,631.4 $3,631.4 $ 3,631.4 $(492.6) $(492.6) $(492.6) $ (492.6) $3,537.3 $3,537.3 $3,537.3 $ 3,537.3 Investing activities Investing activities Investing activities $(945.4) $(945.4) $(945.4) $ (945.4) $(3,770.0) $(3,770.0) $(3,770.0) $ (3,770.0) $(3,141.7) $(3,141.7) $(3,141.7) $ (3,141.7) Financing activities Financing activities Financing activities $(2,261.3) $(2,261.3) $(2,261.3) $ (2,261.3) $(1,494.9) $(1,494.9) $(1,494.9) $ (1,494.9) $(562.2) $(562.2) $(562.2) $ (562.2) Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities. Investing Activities Cash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing Activities Cash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 55Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 55 55 55 Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below."
    },
    {
      "status": "ADDED",
      "current_title": "Year ended December 31,",
      "prior_title": null,
      "current_body": "2025 2025 2025 2024 2024 2024 2023 2023 2023 Net income (loss) Net income (loss) Net income (loss) $3,953.2 $3,953.2 $3,953.2 $ 3,953.2 $(535.6) $(535.6) $(535.6) $ (535.6) $3,619.6 $3,619.6 $3,619.6 $ 3,619.6 Other comprehensive (loss) income: Other comprehensive (loss) income: Other comprehensive (loss) income: Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively 26.9 26.9 26.9 26.9 (2.5) (2.5) (2.5) (2.5) 9.7 9.7 9.7 9.7 Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively (198.1) (198.1) (198.1) (198.1) 136.0 136.0 136.0 136.0 (50.9) (50.9) (50.9) (50.9) Foreign currency translation adjustment Foreign currency translation adjustment Foreign currency translation adjustment 27.5 27.5 27.5 27.5 8.6 8.6 8.6 8.6 26.1 26.1 26.1 26.1 Total other comprehensive (loss) income Total other comprehensive (loss) income Total other comprehensive (loss) income (143.7) (143.7) (143.7) (143.7) 142.1 142.1 142.1 142.1 (15.1) (15.1) (15.1) (15.1) Comprehensive income (loss) Comprehensive income (loss) Comprehensive income (loss) $3,809.5 $3,809.5 $3,809.5 $ 3,809.5 $(393.5) $(393.5) $(393.5) $ (393.5) $3,604.5 $3,604.5 $3,604.5 $ 3,604.5 The accompanying notes are an integral part of these consolidated financial statements. F-5VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Balance Sheets(in millions, except share and per share data)December 31,20252024AssetsCurrent assets:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Accounts receivable, net2,052.81,609.4Inventories1,686.81,205.4Prepaid expenses and other current assets853.3665.7Total current assets11,201.09,596.4Property and equipment, net1,520.31,227.8Goodwill1,088.01,088.0Other intangible assets, net424.2825.9Deferred tax assets2,897.92,331.1Operating lease assets1,562.71,356.8Long-term marketable securities5,712.35,107.9Other assets1,236.6999.3Total assets$25,643.0$22,533.2Liabilities and Shareholders’ EquityCurrent liabilities:Accounts payable$461.7$413.0Accrued expenses2,971.22,788.6Other current liabilities428.3363.0Total current liabilities3,861.23,564.6Long-term operating lease liabilities1,846.51,544.4Other long-term liabilities1,269.51,014.6Total liabilities6,977.26,123.6Commitments and contingencies (Note P)Shareholders’ equity:Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding——Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively2.52.6Additional paid-in capital5,119.26,672.4Accumulated other comprehensive (loss) income(15.9)127.8Retained earnings13,560.09,606.8Total shareholders’ equity18,665.816,409.6Total liabilities and shareholders’ equity$25,643.0$22,533.2The accompanying notes are an integral part of these consolidated financial statements. F-5 F-5 F-5 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Balance Sheets(in millions, except share and per share data)December 31,20252024AssetsCurrent assets:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Accounts receivable, net2,052.81,609.4Inventories1,686.81,205.4Prepaid expenses and other current assets853.3665.7Total current assets11,201.09,596.4Property and equipment, net1,520.31,227.8Goodwill1,088.01,088.0Other intangible assets, net424.2825.9Deferred tax assets2,897.92,331.1Operating lease assets1,562.71,356.8Long-term marketable securities5,712.35,107.9Other assets1,236.6999.3Total assets$25,643.0$22,533.2Liabilities and Shareholders’ EquityCurrent liabilities:Accounts payable$461.7$413.0Accrued expenses2,971.22,788.6Other current liabilities428.3363.0Total current liabilities3,861.23,564.6Long-term operating lease liabilities1,846.51,544.4Other long-term liabilities1,269.51,014.6Total liabilities6,977.26,123.6Commitments and contingencies (Note P)Shareholders’ equity:Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding——Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively2.52.6Additional paid-in capital5,119.26,672.4Accumulated other comprehensive (loss) income(15.9)127.8Retained earnings13,560.09,606.8Total shareholders’ equity18,665.816,409.6Total liabilities and shareholders’ equity$25,643.0$22,533.2The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "(in millions, except share and per share data)",
      "prior_title": null,
      "current_body": "pt share and per share data) December 31,20252024AssetsCurrent assets:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Accounts receivable, net2,052.81,609.4Inventories1,686.81,205.4Prepaid expenses and other current assets853.3665.7Total current assets11,201.09,596.4Property and equipment, net1,520.31,227.8Goodwill1,088.01,088.0Other intangible assets, net424.2825.9Deferred tax assets2,897.92,331.1Operating lease assets1,562.71,356.8Long-term marketable securities5,712.35,107.9Other assets1,236.6999.3Total assets$25,643.0$22,533.2Liabilities and Shareholders’ EquityCurrent liabilities:Accounts payable$461.7$413.0Accrued expenses2,971.22,788.6Other current liabilities428.3363.0Total current liabilities3,861.23,564.6Long-term operating lease liabilities1,846.51,544.4Other long-term liabilities1,269.51,014.6Total liabilities6,977.26,123.6Commitments and contingencies (Note P)Shareholders’ equity:Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding——Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively2.52.6Additional paid-in capital5,119.26,672.4Accumulated other comprehensive (loss) income(15.9)127.8Retained earnings13,560.09,606.8Total shareholders’ equity18,665.816,409.6Total liabilities and shareholders’ equity$25,643.0$22,533.2 December 31,20252024AssetsCurrent assets:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Accounts receivable, net2,052.81,609.4Inventories1,686.81,205.4Prepaid expenses and other current assets853.3665.7Total current assets11,201.09,596.4Property and equipment, net1,520.31,227.8Goodwill1,088.01,088.0Other intangible assets, net424.2825.9Deferred tax assets2,897.92,331.1Operating lease assets1,562.71,356.8Long-term marketable securities5,712.35,107.9Other assets1,236.6999.3Total assets$25,643.0$22,533.2Liabilities and Shareholders’ EquityCurrent liabilities:Accounts payable$461.7$413.0Accrued expenses2,971.22,788.6Other current liabilities428.3363.0Total current liabilities3,861.23,564.6Long-term operating lease liabilities1,846.51,544.4Other long-term liabilities1,269.51,014.6Total liabilities6,977.26,123.6Commitments and contingencies (Note P)Shareholders’ equity:Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding——Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively2.52.6Additional paid-in capital5,119.26,672.4Accumulated other comprehensive (loss) income(15.9)127.8Retained earnings13,560.09,606.8Total shareholders’ equity18,665.816,409.6Total liabilities and shareholders’ equity$25,643.0$22,533.2 December 31,20252024AssetsCurrent assets:Cash and cash equivalents$5,084.8$4,569.6Marketable securities1,523.31,546.3Accounts receivable, net2,052.81,609.4Inventories1,686.81,205.4Prepaid expenses and other current assets853.3665.7Total current assets11,201.09,596.4Property and equipment, net1,520.31,227.8Goodwill1,088.01,088.0Other intangible assets, net424.2825.9Deferred tax assets2,897.92,331.1Operating lease assets1,562.71,356.8Long-term marketable securities5,712.35,107.9Other assets1,236.6999.3Total assets$25,643.0$22,533.2Liabilities and Shareholders’ EquityCurrent liabilities:Accounts payable$461.7$413.0Accrued expenses2,971.22,788.6Other current liabilities428.3363.0Total current liabilities3,861.23,564.6Long-term operating lease liabilities1,846.51,544.4Other long-term liabilities1,269.51,014.6Total liabilities6,977.26,123.6Commitments and contingencies (Note P)Shareholders’ equity:Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding——Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively2.52.6Additional paid-in capital5,119.26,672.4Accumulated other comprehensive (loss) income(15.9)127.8Retained earnings13,560.09,606.8Total shareholders’ equity18,665.816,409.6Total liabilities and shareholders’ equity$25,643.0$22,533.2"
    },
    {
      "status": "ADDED",
      "current_title": "December 31,",
      "prior_title": null,
      "current_body": "2025 2025 2025 2024 2024 2024 Assets Assets Assets Current assets: Current assets: Current assets: Cash and cash equivalents Cash and cash equivalents Cash and cash equivalents $5,084.8 $5,084.8 $5,084.8 $ 5,084.8 $4,569.6 $4,569.6 $4,569.6 $ 4,569.6 Marketable securities Marketable securities Marketable securities 1,523.3 1,523.3 1,523.3 1,523.3 1,546.3 1,546.3 1,546.3 1,546.3 Accounts receivable, net Accounts receivable, net Accounts receivable, net 2,052.8 2,052.8 2,052.8 2,052.8 1,609.4 1,609.4 1,609.4 1,609.4 Inventories Inventories Inventories 1,686.8 1,686.8 1,686.8 1,686.8 1,205.4 1,205.4 1,205.4 1,205.4 Prepaid expenses and other current assets Prepaid expenses and other current assets Prepaid expenses and other current assets 853.3 853.3 853.3 853.3 665.7 665.7 665.7 665.7 Total current assets Total current assets Total current assets 11,201.0 11,201.0 11,201.0 11,201.0 9,596.4 9,596.4 9,596.4 9,596.4 Property and equipment, net Property and equipment, net Property and equipment, net 1,520.3 1,520.3 1,520.3 1,520.3 1,227.8 1,227.8 1,227.8 1,227.8 Goodwill Goodwill Goodwill 1,088.0 1,088.0 1,088.0 1,088.0 1,088.0 1,088.0 1,088.0 1,088.0 Other intangible assets, net Other intangible assets, net Other intangible assets, net 424.2 424.2 424.2 424.2 825.9 825.9 825.9 825.9 Deferred tax assets Deferred tax assets Deferred tax assets 2,897.9 2,897.9 2,897.9 2,897.9 2,331.1 2,331.1 2,331.1 2,331.1 Operating lease assets Operating lease assets Operating lease assets 1,562.7 1,562.7 1,562.7 1,562.7 1,356.8 1,356.8 1,356.8 1,356.8 Long-term marketable securities Long-term marketable securities Long-term marketable securities 5,712.3 5,712.3 5,712.3 5,712.3 5,107.9 5,107.9 5,107.9 5,107.9 Other assets Other assets Other assets 1,236.6 1,236.6 1,236.6 1,236.6 999.3 999.3 999.3 999.3 Total assets Total assets Total assets $25,643.0 $25,643.0 $25,643.0 $ 25,643.0 $22,533.2 $22,533.2 $22,533.2 $ 22,533.2"
    },
    {
      "status": "ADDED",
      "current_title": "Liabilities and Shareholders’ Equity",
      "prior_title": null,
      "current_body": "Current liabilities: Current liabilities: Current liabilities: Accounts payable Accounts payable Accounts payable $461.7 $461.7 $461.7 $ 461.7 $413.0 $413.0 $413.0 $ 413.0 Accrued expenses Accrued expenses Accrued expenses 2,971.2 2,971.2 2,971.2 2,971.2 2,788.6 2,788.6 2,788.6 2,788.6 Other current liabilities Other current liabilities Other current liabilities 428.3 428.3 428.3 428.3 363.0 363.0 363.0 363.0 Total current liabilities Total current liabilities Total current liabilities 3,861.2 3,861.2 3,861.2 3,861.2 3,564.6 3,564.6 3,564.6 3,564.6 Long-term operating lease liabilities Long-term operating lease liabilities Long-term operating lease liabilities 1,846.5 1,846.5 1,846.5 1,846.5 1,544.4 1,544.4 1,544.4 1,544.4 Other long-term liabilities Other long-term liabilities Other long-term liabilities 1,269.5 1,269.5 1,269.5 1,269.5 1,014.6 1,014.6 1,014.6 1,014.6 Total liabilities Total liabilities Total liabilities 6,977.2 6,977.2 6,977.2 6,977.2 6,123.6 6,123.6 6,123.6 6,123.6 Commitments and contingencies (Note P) Commitments and contingencies (Note P) Commitments and contingencies (Note P) Shareholders’ equity: Shareholders’ equity: Shareholders’ equity: Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding Preferred stock, $0.01 par value; 1,000,000 shares authorized; none issued and outstanding — — — — — — — — Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively Common stock, $0.01 par value; 500,000,000 shares authorized, 253,991,224 and 256,940,382 shares issued and outstanding, respectively 2.5 2.5 2.5 2.5 2.6 2.6 2.6 2.6 Additional paid-in capital Additional paid-in capital Additional paid-in capital 5,119.2 5,119.2 5,119.2 5,119.2 6,672.4 6,672.4 6,672.4 6,672.4 Accumulated other comprehensive (loss) income Accumulated other comprehensive (loss) income Accumulated other comprehensive (loss) income (15.9) (15.9) (15.9) (15.9) 127.8 127.8 127.8 127.8 Retained earnings Retained earnings Retained earnings 13,560.0 13,560.0 13,560.0 13,560.0 9,606.8 9,606.8 9,606.8 9,606.8 Total shareholders’ equity Total shareholders’ equity Total shareholders’ equity 18,665.8 18,665.8 18,665.8 18,665.8 16,409.6 16,409.6 16,409.6 16,409.6 Total liabilities and shareholders’ equity Total liabilities and shareholders’ equity Total liabilities and shareholders’ equity $25,643.0 $25,643.0 $25,643.0 $ 25,643.0 $22,533.2 $22,533.2 $22,533.2 $ 22,533.2 The accompanying notes are an integral part of these consolidated financial statements. F-6VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Shareholders’ Equity(in millions)Common StockAdditional Paid-in CapitalAccumulated Other Comprehensive Income (Loss)Retained EarningsTotal Shareholders’ EquitySharesAmountBalance at December 31, 2022257.0$2.6$7,386.5$0.8$6,522.8$13,912.7Other comprehensive loss, net of tax———(15.1)—(15.1)Net income————3,619.63,619.6Repurchases of common stock(1.3)—(427.6)——(427.6)Common stock withheld for employee tax obligations(0.7)—(226.1)——(226.1)Issuance of common stock under benefit plans2.7—133.4——133.4Stock-based compensation expense——583.5——583.5Balance at December 31, 2023257.7$2.6$7,449.7$(14.3)$10,142.4$17,580.4Other comprehensive income, net of tax———142.1—142.1Net loss————(535.6)(535.6)Repurchases of common stock(2.7)—(1,194.9)——(1,194.9)Common stock withheld for employee tax obligations(0.9)—(405.0)——(405.0)Issuance of common stock under benefit plans2.8—113.5——113.5Stock-based compensation expense——709.1——709.1Balance at December 31, 2024256.9$2.6$6,672.4$127.8$9,606.8$16,409.6Other comprehensive loss, net of tax———(143.7)—(143.7)Net income————3,953.23,953.2Repurchases of common stock(4.8)(0.1)(2,011.5)——(2,011.6)Common stock withheld for employee tax obligations(0.7)—(369.9)——(369.9)Issuance of common stock under benefit plans2.6—127.9——127.9Stock-based compensation expense——700.3——700.3Balance at December 31, 2025254.0$2.5$5,119.2$(15.9)$13,560.0$18,665.8The accompanying notes are an integral part of these consolidated financial statements. F-6 F-6 F-6 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Shareholders’ Equity(in millions)Common StockAdditional Paid-in CapitalAccumulated Other Comprehensive Income (Loss)Retained EarningsTotal Shareholders’ EquitySharesAmountBalance at December 31, 2022257.0$2.6$7,386.5$0.8$6,522.8$13,912.7Other comprehensive loss, net of tax———(15.1)—(15.1)Net income————3,619.63,619.6Repurchases of common stock(1.3)—(427.6)——(427.6)Common stock withheld for employee tax obligations(0.7)—(226.1)——(226.1)Issuance of common stock under benefit plans2.7—133.4——133.4Stock-based compensation expense——583.5——583.5Balance at December 31, 2023257.7$2.6$7,449.7$(14.3)$10,142.4$17,580.4Other comprehensive income, net of tax———142.1—142.1Net loss————(535.6)(535.6)Repurchases of common stock(2.7)—(1,194.9)——(1,194.9)Common stock withheld for employee tax obligations(0.9)—(405.0)——(405.0)Issuance of common stock under benefit plans2.8—113.5——113.5Stock-based compensation expense——709.1——709.1Balance at December 31, 2024256.9$2.6$6,672.4$127.8$9,606.8$16,409.6Other comprehensive loss, net of tax———(143.7)—(143.7)Net income————3,953.23,953.2Repurchases of common stock(4.8)(0.1)(2,011.5)——(2,011.6)Common stock withheld for employee tax obligations(0.7)—(369.9)——(369.9)Issuance of common stock under benefit plans2.6—127.9——127.9Stock-based compensation expense——700.3——700.3Balance at December 31, 2025254.0$2.5$5,119.2$(15.9)$13,560.0$18,665.8The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "(in millions)",
      "prior_title": null,
      "current_body": "Net cash provided by (used in): Net cash provided by (used in): Net cash provided by (used in): Operating activities Operating activities Operating activities $3,631.4 $3,631.4 $3,631.4 $ 3,631.4 $(492.6) $(492.6) $(492.6) $ (492.6) $3,537.3 $3,537.3 $3,537.3 $ 3,537.3 Investing activities Investing activities Investing activities $(945.4) $(945.4) $(945.4) $ (945.4) $(3,770.0) $(3,770.0) $(3,770.0) $ (3,770.0) $(3,141.7) $(3,141.7) $(3,141.7) $ (3,141.7) Financing activities Financing activities Financing activities $(2,261.3) $(2,261.3) $(2,261.3) $ (2,261.3) $(1,494.9) $(1,494.9) $(1,494.9) $ (1,494.9) $(562.2) $(562.2) $(562.2) $ (562.2) Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities. Investing Activities Cash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing Activities Cash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 55Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 55 55 55 Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below."
    },
    {
      "status": "ADDED",
      "current_title": "Balance at December 31, 2022",
      "prior_title": null,
      "current_body": "257.0 257.0 257.0 257.0 $2.6 $2.6 $2.6 $ 2.6 $7,386.5 $7,386.5 $7,386.5 $ 7,386.5 $0.8 $0.8 $0.8 $ 0.8 $6,522.8 $6,522.8 $6,522.8 $ 6,522.8 $13,912.7 $13,912.7 $13,912.7 $ 13,912.7 Other comprehensive loss, net of tax Other comprehensive loss, net of tax Other comprehensive loss, net of tax — — — — — — — — — — — — (15.1) (15.1) (15.1) (15.1) — — — — (15.1) (15.1) (15.1) (15.1) Net income Net income Net income — — — — — — — — — — — — — — — — 3,619.6 3,619.6 3,619.6 3,619.6 3,619.6 3,619.6 3,619.6 3,619.6 Repurchases of common stock Repurchases of common stock Repurchases of common stock (1.3) (1.3) (1.3) (1.3) — — — — (427.6) (427.6) (427.6) (427.6) — — — — — — — — (427.6) (427.6) (427.6) (427.6) Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations (0.7) (0.7) (0.7) (0.7) — — — — (226.1) (226.1) (226.1) (226.1) — — — — — — — — (226.1) (226.1) (226.1) (226.1) Issuance of common stock under benefit plans Issuance of common stock under benefit plans Issuance of common stock under benefit plans 2.7 2.7 2.7 2.7 — — — — 133.4 133.4 133.4 133.4 — — — — — — — — 133.4 133.4 133.4 133.4 Stock-based compensation expense Stock-based compensation expense Stock-based compensation expense — — — — — — — — 583.5 583.5 583.5 583.5 — — — — — — — — 583.5 583.5 583.5 583.5"
    },
    {
      "status": "ADDED",
      "current_title": "Balance at December 31, 2023",
      "prior_title": null,
      "current_body": "257.7 257.7 257.7 257.7 $2.6 $2.6 $2.6 $ 2.6 $7,449.7 $7,449.7 $7,449.7 $ 7,449.7 $(14.3) $(14.3) $(14.3) $ (14.3) $10,142.4 $10,142.4 $10,142.4 $ 10,142.4 $17,580.4 $17,580.4 $17,580.4 $ 17,580.4 Other comprehensive income, net of tax Other comprehensive income, net of tax Other comprehensive income, net of tax — — — — — — — — — — — — 142.1 142.1 142.1 142.1 — — — — 142.1 142.1 142.1 142.1 Net loss Net loss Net loss — — — — — — — — — — — — — — — — (535.6) (535.6) (535.6) (535.6) (535.6) (535.6) (535.6) (535.6) Repurchases of common stock Repurchases of common stock Repurchases of common stock (2.7) (2.7) (2.7) (2.7) — — — — (1,194.9) (1,194.9) (1,194.9) (1,194.9) — — — — — — — — (1,194.9) (1,194.9) (1,194.9) (1,194.9) Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations (0.9) (0.9) (0.9) (0.9) — — — — (405.0) (405.0) (405.0) (405.0) — — — — — — — — (405.0) (405.0) (405.0) (405.0) Issuance of common stock under benefit plans Issuance of common stock under benefit plans Issuance of common stock under benefit plans 2.8 2.8 2.8 2.8 — — — — 113.5 113.5 113.5 113.5 — — — — — — — — 113.5 113.5 113.5 113.5 Stock-based compensation expense Stock-based compensation expense Stock-based compensation expense — — — — — — — — 709.1 709.1 709.1 709.1 — — — — — — — — 709.1 709.1 709.1 709.1"
    },
    {
      "status": "ADDED",
      "current_title": "Balance at December 31, 2024",
      "prior_title": null,
      "current_body": "256.9 256.9 256.9 256.9 $2.6 $2.6 $2.6 $ 2.6 $6,672.4 $6,672.4 $6,672.4 $ 6,672.4 $127.8 $127.8 $127.8 $ 127.8 $9,606.8 $9,606.8 $9,606.8 $ 9,606.8 $16,409.6 $16,409.6 $16,409.6 $ 16,409.6 Other comprehensive loss, net of tax Other comprehensive loss, net of tax Other comprehensive loss, net of tax — — — — — — — — — — — — (143.7) (143.7) (143.7) (143.7) — — — — (143.7) (143.7) (143.7) (143.7) Net income Net income Net income — — — — — — — — — — — — — — — — 3,953.2 3,953.2 3,953.2 3,953.2 3,953.2 3,953.2 3,953.2 3,953.2 Repurchases of common stock Repurchases of common stock Repurchases of common stock (4.8) (4.8) (4.8) (4.8) (0.1) (0.1) (0.1) (0.1) (2,011.5) (2,011.5) (2,011.5) (2,011.5) — — — — — — — — (2,011.6) (2,011.6) (2,011.6) (2,011.6) Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations Common stock withheld for employee tax obligations (0.7) (0.7) (0.7) (0.7) — — — — (369.9) (369.9) (369.9) (369.9) — — — — — — — — (369.9) (369.9) (369.9) (369.9) Issuance of common stock under benefit plans Issuance of common stock under benefit plans Issuance of common stock under benefit plans 2.6 2.6 2.6 2.6 — — — — 127.9 127.9 127.9 127.9 — — — — — — — — 127.9 127.9 127.9 127.9 Stock-based compensation expense Stock-based compensation expense Stock-based compensation expense — — — — — — — — 700.3 700.3 700.3 700.3 — — — — — — — — 700.3 700.3 700.3 700.3"
    },
    {
      "status": "ADDED",
      "current_title": "Balance at December 31, 2025",
      "prior_title": null,
      "current_body": "254.0 254.0 254.0 254.0 $2.5 $2.5 $2.5 $ 2.5 $5,119.2 $5,119.2 $5,119.2 $ 5,119.2 $(15.9) $(15.9) $(15.9) $ (15.9) $13,560.0 $13,560.0 $13,560.0 $ 13,560.0 $18,665.8 $18,665.8 $18,665.8 $ 18,665.8 The accompanying notes are an integral part of these consolidated financial statements. F-7VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Cash Flows(in millions)Year Ended December 31,202520242023Cash flows from operating activities:Net income (loss)$3,953.2$(535.6)$3,619.6Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:Stock-based compensation expense685.9698.5581.2Depreciation and amortization expense209.8207.2181.3Intangible asset impairment charges379.0——Deferred income taxes(510.8)(348.8)(536.5)Other non-cash items, net113.40.9(42.6)Changes in operating assets and liabilities:Accounts receivable, net(347.3)(99.3)(84.1)Inventories(524.2)(517.3)(322.9)Prepaid expenses and other assets(396.0)(200.3)(545.7)Accounts payable36.849.548.7Accrued expenses(116.9)212.9429.4Other liabilities148.539.7208.9Net cash provided by (used in) operating activities3,631.4(492.6)3,537.3Cash flows from investing activities:Purchases of available-for-sale debt securities(6,396.5)(7,438.2)(3,786.5)Sales and maturities of available-for-sale debt securities5,897.44,465.6839.1Purchases of property and equipment(437.6)(297.7)(200.4)Proceeds related to equity securities16.0—95.1Net payments related to finite-lived intangible assets—(187.7)(58.0)Acquisition of available-for-sale debt securities from Alpine Immune Sciences, Inc.—(258.0)—Other investing activities(24.7)(54.0)(31.0)Net cash used in investing activities(945.4)(3,770.0)(3,141.7)Cash flows from financing activities:Issuances of common stock under benefit plans127.7114.6134.6Repurchases of common stock(2,017.4)(1,177.1)(427.6)Payments in connection with common stock withheld for employee tax obligations(369.9)(405.0)(226.1)Payments on finance leases(5.4)(33.6)(44.9)Other financing activities3.76.21.8Net cash used in financing activities(2,261.3)(1,494.9)(562.2)Effect of changes in exchange rates on cash90.9(42.6)26.9Net increase (decrease) in cash, cash equivalents and restricted cash515.6(5,800.1)(139.7)Cash, cash equivalents and restricted cash—beginning of period4,572.210,372.310,512.0Cash, cash equivalents and restricted cash—end of period$5,087.8$4,572.2$10,372.3Supplemental disclosure of cash flow information:Cash paid for income taxes$1,566.7$1,082.1$1,677.3Cash paid for interest$12.4$30.5$43.1Net payments due to CRISPR Therapeutics AG related to finite-lived intangible assets$—$—$180.0The accompanying notes are an integral part of these consolidated financial statements. F-7 F-7 F-7 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Cash Flows(in millions)Year Ended December 31,202520242023Cash flows from operating activities:Net income (loss)$3,953.2$(535.6)$3,619.6Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:Stock-based compensation expense685.9698.5581.2Depreciation and amortization expense209.8207.2181.3Intangible asset impairment charges379.0——Deferred income taxes(510.8)(348.8)(536.5)Other non-cash items, net113.40.9(42.6)Changes in operating assets and liabilities:Accounts receivable, net(347.3)(99.3)(84.1)Inventories(524.2)(517.3)(322.9)Prepaid expenses and other assets(396.0)(200.3)(545.7)Accounts payable36.849.548.7Accrued expenses(116.9)212.9429.4Other liabilities148.539.7208.9Net cash provided by (used in) operating activities3,631.4(492.6)3,537.3Cash flows from investing activities:Purchases of available-for-sale debt securities(6,396.5)(7,438.2)(3,786.5)Sales and maturities of available-for-sale debt securities5,897.44,465.6839.1Purchases of property and equipment(437.6)(297.7)(200.4)Proceeds related to equity securities16.0—95.1Net payments related to finite-lived intangible assets—(187.7)(58.0)Acquisition of available-for-sale debt securities from Alpine Immune Sciences, Inc.—(258.0)—Other investing activities(24.7)(54.0)(31.0)Net cash used in investing activities(945.4)(3,770.0)(3,141.7)Cash flows from financing activities:Issuances of common stock under benefit plans127.7114.6134.6Repurchases of common stock(2,017.4)(1,177.1)(427.6)Payments in connection with common stock withheld for employee tax obligations(369.9)(405.0)(226.1)Payments on finance leases(5.4)(33.6)(44.9)Other financing activities3.76.21.8Net cash used in financing activities(2,261.3)(1,494.9)(562.2)Effect of changes in exchange rates on cash90.9(42.6)26.9Net increase (decrease) in cash, cash equivalents and restricted cash515.6(5,800.1)(139.7)Cash, cash equivalents and restricted cash—beginning of period4,572.210,372.310,512.0Cash, cash equivalents and restricted cash—end of period$5,087.8$4,572.2$10,372.3Supplemental disclosure of cash flow information:Cash paid for income taxes$1,566.7$1,082.1$1,677.3Cash paid for interest$12.4$30.5$43.1Net payments due to CRISPR Therapeutics AG related to finite-lived intangible assets$—$—$180.0The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "(in millions)",
      "prior_title": null,
      "current_body": "Net cash provided by (used in): Net cash provided by (used in): Net cash provided by (used in): Operating activities Operating activities Operating activities $3,631.4 $3,631.4 $3,631.4 $ 3,631.4 $(492.6) $(492.6) $(492.6) $ (492.6) $3,537.3 $3,537.3 $3,537.3 $ 3,537.3 Investing activities Investing activities Investing activities $(945.4) $(945.4) $(945.4) $ (945.4) $(3,770.0) $(3,770.0) $(3,770.0) $ (3,770.0) $(3,141.7) $(3,141.7) $(3,141.7) $ (3,141.7) Financing activities Financing activities Financing activities $(2,261.3) $(2,261.3) $(2,261.3) $ (2,261.3) $(1,494.9) $(1,494.9) $(1,494.9) $ (1,494.9) $(562.2) $(562.2) $(562.2) $ (562.2) Operating Activities Cash provided by operating activities was $3.6 billion in 2025, primarily due to income from operations of $4.2 billion driven by our net product revenues partially offset by purchases of inventory and other changes in operating assets and liabilities. Cash used in operating activities was $492.6 million in 2024, primarily due to our acquisition of Alpine partially offset by cash flows provided by other operating activities. Investing Activities Cash used in investing activities was $945.4 million in 2025, primarily related to net purchases of available-for-sale debt securities and purchases of property and equipment. Cash used in investing activities was $3.8 billion in 2024, which included net purchases of available-for-sale debt securities of $3.0 billion. Financing Activities Cash used in financing activities were $2.3 billion and $1.5 billion in 2025 and 2024, respectively. Our financing activities in each year were primarily related to repurchases of our common stock pursuant to our share repurchase programs and payments in connection with common stock withheld for employee tax obligations. 55Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below. 55 55 55 Sources and Uses of LiquidityWe intend to rely on our existing cash, cash equivalents and current marketable securities together with our operating profitability as our primary source of liquidity. We expect that cash flows from our product sales together with our cash, cash equivalents and current marketable securities will be sufficient to fund our operations for at least the next twelve months. The adequacy of our available funds to meet our future operating and capital requirements will depend on many factors, including our future sales of currently marketed products, and the potential introduction of one or more new product candidates to the market, our business development activities, and the number, breadth and cost of our research and development programs.Credit Facilities & Financing StrategyWe may borrow up to a total of $500.0 million pursuant to a revolving credit facility that we entered into in July 2022 and could repay and reborrow amounts under this revolving credit agreement without penalty. Subject to certain conditions, we could request that the borrowing capacity be increased by an additional $500.0 million, for a total of $1.0 billion. Negative covenants in our credit agreement could prohibit or limit our ability to access this source of liquidity. As of December 31, 2025, the facility was undrawn, and we were in compliance with these covenants.We may also raise additional capital by borrowing under credit agreements, through public offerings or private placements of our securities, or securing new collaborative agreements or other methods of financing. We will continue to manage our capital structure and will consider all financing opportunities, whenever they may occur, that could strengthen our long-term liquidity profile. There can be no assurance that any such financing opportunities will be available on acceptable terms, if at all.Future Capital RequirementsWe have significant future capital requirements, including:•Expected operating expenses to conduct research and development activities, manufacture and commercialize our existing and future products, and to operate our organization.•Cash that we pay for income taxes.•Royalties we pay related to sales of our CF products.•Facility, operating and finance lease obligations as described below.•Firm purchase obligations related to our supply and manufacturing processes.In addition, other potential significant future capital requirements may include:•We have entered into certain agreements with third parties that include the funding of certain research, development, manufacturing and commercialization efforts. Certain of our transactions, including collaborations, licensing arrangements, and asset acquisitions, include the potential for future milestone and royalty payments by us upon the achievement of pre-established developmental and regulatory targets and/or commercial targets. Other transactions include the potential for future lease-related expenses and other costs. Our obligation to fund these research and development and commercialization efforts and to pay these potential milestones, expenses and royalties is contingent upon continued involvement in the programs and/or the lack of any adverse events that could cause their discontinuance. We may enter into additional agreements, including acquisitions, collaborations, licensing arrangements and equity investments, which require additional capital.•To the extent we borrow amounts under our existing credit agreement, we would be required to repay any outstanding principal amounts in 2027.•As of December 31, 2025, we had $3.4 billion remaining authorization available under the share repurchase program that our Board of Directors approved in May 2025. The program does not have an expiration date and can be discontinued at any time. We expect to fund the program through a combination of cash on hand and cash generated by operations. Additional information on several of our future capital requirements is provided below."
    },
    {
      "status": "ADDED",
      "current_title": "Year Ended December 31,",
      "prior_title": null,
      "current_body": "2025 2025 2025 2024 2024 2024 2023 2023 2023 Revenues: Revenues: Revenues: Product revenues, net Product revenues, net Product revenues, net $11,970.6 $11,970.6 $11,970.6 $ 11,970.6 $11,020.1 $11,020.1 $11,020.1 $ 11,020.1 $9,869.2 $9,869.2 $9,869.2 $ 9,869.2 Other revenues Other revenues Other revenues 30.7 30.7 30.7 30.7 — — — — — — — — Total revenues Total revenues Total revenues 12,001.3 12,001.3 12,001.3 12,001.3 11,020.1 11,020.1 11,020.1 11,020.1 9,869.2 9,869.2 9,869.2 9,869.2 Costs and expenses: Costs and expenses: Costs and expenses: Cost of sales Cost of sales Cost of sales 1,651.3 1,651.3 1,651.3 1,651.3 1,530.5 1,530.5 1,530.5 1,530.5 1,262.2 1,262.2 1,262.2 1,262.2 Research and development expenses Research and development expenses Research and development expenses Research and development expenses 3,909.5 3,909.5 3,909.5 3,909.5 3,630.3 3,630.3 3,630.3 3,630.3 3,162.9 3,162.9 3,162.9 3,162.9 Acquired in-process research and development expenses Acquired in-process research and development expenses Acquired in-process research and development expenses 133.0 133.0 133.0 133.0 4,628.4 4,628.4 4,628.4 4,628.4 527.1 527.1 527.1 527.1 Selling, general and administrative expenses Selling, general and administrative expenses Selling, general and administrative expenses 1,753.1 1,753.1 1,753.1 1,753.1 1,464.3 1,464.3 1,464.3 1,464.3 1,136.6 1,136.6 1,136.6 1,136.6 Intangible asset impairment charge Intangible asset impairment charge Intangible asset impairment charge 379.0 379.0 379.0 379.0 — — — — — — — — Change in fair value of contingent consideration Change in fair value of contingent consideration Change in fair value of contingent consideration 2.1 2.1 2.1 2.1 (0.5) (0.5) (0.5) (0.5) (51.6) (51.6) (51.6) (51.6) Total costs and expenses Total costs and expenses Total costs and expenses 7,828.0 7,828.0 7,828.0 7,828.0 11,253.0 11,253.0 11,253.0 11,253.0 6,037.2 6,037.2 6,037.2 6,037.2 Income (loss) from operations Income (loss) from operations Income (loss) from operations 4,173.3 4,173.3 4,173.3 4,173.3 (232.9) (232.9) (232.9) (232.9) 3,832.0 3,832.0 3,832.0 3,832.0 Interest income Interest income Interest income 490.9 490.9 490.9 490.9 598.1 598.1 598.1 598.1 614.7 614.7 614.7 614.7 Interest expense Interest expense Interest expense (13.3) (13.3) (13.3) (13.3) (30.6) (30.6) (30.6) (30.6) (44.1) (44.1) (44.1) (44.1) Other expense, net Other expense, net Other expense, net (7.7) (7.7) (7.7) (7.7) (86.1) (86.1) (86.1) (86.1) (22.8) (22.8) (22.8) (22.8) Income before provision for income taxes Income before provision for income taxes Income before provision for income taxes 4,643.2 4,643.2 4,643.2 4,643.2 248.5 248.5 248.5 248.5 4,379.8 4,379.8 4,379.8 4,379.8 Provision for income taxes Provision for income taxes Provision for income taxes 690.0 690.0 690.0 690.0 784.1 784.1 784.1 784.1 760.2 760.2 760.2 760.2 Net income (loss) Net income (loss) Net income (loss) $3,953.2 $3,953.2 $3,953.2 $ 3,953.2 $(535.6) $(535.6) $(535.6) $ (535.6) $3,619.6 $3,619.6 $3,619.6 $ 3,619.6 Net income (loss) per common share: Net income (loss) per common share: Net income (loss) per common share: Basic Basic Basic $15.46 $15.46 $15.46 $ 15.46 $(2.08) $(2.08) $(2.08) $ (2.08) $14.05 $14.05 $14.05 $ 14.05 Diluted Diluted Diluted $15.32 $15.32 $15.32 $ 15.32 $(2.08) $(2.08) $(2.08) $ (2.08) $13.89 $13.89 $13.89 $ 13.89 Shares used in per share calculations: Shares used in per share calculations: Shares used in per share calculations: Basic Basic Basic 255.7 255.7 255.7 255.7 257.9 257.9 257.9 257.9 257.7 257.7 257.7 257.7 Diluted Diluted Diluted 258.0 258.0 258.0 258.0 257.9 257.9 257.9 257.9 260.5 260.5 260.5 260.5 The accompanying notes are an integral part of these consolidated financial statements. F-4VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Comprehensive Income (Loss)(in millions)Year ended December 31,202520242023Net income (loss)$3,953.2$(535.6)$3,619.6Other comprehensive (loss) income:Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively26.9(2.5)9.7Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively(198.1)136.0(50.9)Foreign currency translation adjustment27.58.626.1Total other comprehensive (loss) income(143.7)142.1(15.1)Comprehensive income (loss)$3,809.5$(393.5)$3,604.5The accompanying notes are an integral part of these consolidated financial statements. F-4 F-4 F-4 VERTEX PHARMACEUTICALS INCORPORATEDConsolidated Statements of Comprehensive Income (Loss)(in millions)Year ended December 31,202520242023Net income (loss)$3,953.2$(535.6)$3,619.6Other comprehensive (loss) income:Unrealized holding gains (losses) on available-for-sale debt securities, net of tax of $(7.6), $0.6 and $(2.7), respectively26.9(2.5)9.7Unrealized (losses) gains on foreign currency forward contracts, net of tax of $56.0, $(38.2) and $14.0, respectively(198.1)136.0(50.9)Foreign currency translation adjustment27.58.626.1Total other comprehensive (loss) income(143.7)142.1(15.1)Comprehensive income (loss)$3,809.5$(393.5)$3,604.5The accompanying notes are an integral part of these consolidated financial statements."
    },
    {
      "status": "ADDED",
      "current_title": "Notes to Consolidated Financial Statements",
      "prior_title": null,
      "current_body": "A.Nature of Business and Accounting PoliciesBusinessVertex Pharmaceuticals Incorporated (“Vertex,” “we,” “us” or “our”) is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”), sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline includes programs across a range of modalities in additional serious diseases, including IgA nephropathy (“IgAN”), APOL1-mediated kidney disease, neuropathic pain, type 1 diabetes (“T1D”), primary membranous nephropathy (“pMN”), autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1 (“DM1”).Our marketed CF medicines are ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), which was approved by the U.S. Food and Drug Administration (“FDA”) in December 2024, TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO/SYMKEVI (tezacaftor/ivacaftor and ivacaftor), ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor).CASGEVY (exagamglogene autotemcel), our ex-vivo, non-viral CRISPR/Cas9-based gene-editing therapy for severe SCD and TDT, is approved in the United States (“U.S.”) and across multiple geographies including Europe, Canada, and the Middle East. CASGEVY was initially approved by the FDA in December 2023.In January 2025, the FDA approved JOURNAVX (suzetrigine), our first-in-class, oral pain signal inhibitor that is highly selective for voltage-gated sodium channel NaV1.8, for the treatment of moderate-to-severe acute pain in adults.Basis of PresentationThe accompanying consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”), reflect the operations of Vertex and our wholly owned subsidiaries. All material intercompany balances and transactions have been eliminated. We operate in one segment, pharmaceuticals. Please refer to Note Q, “Segment Information,” for enterprise-wide disclosures regarding our revenues, major customers, significant segment expenses, and long-lived assets by geographic area.Use of EstimatesThe preparation of consolidated financial statements in accordance with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of our consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on historical experience and various other assumptions, including in certain circumstances future projections that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known.Revenue RecognitionWe recognize revenue when a customer obtains control of promised goods or services. We record the amount of revenue that reflects the consideration that we expect to receive in exchange for those goods or services. We apply the following five-step model to determine this amount: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services that we transfer to the customer. Once a contract is determined to be within the"
    },
    {
      "status": "ADDED",
      "current_title": "Nature of Business and Accounting Policies",
      "prior_title": null,
      "current_body": "Business Vertex Pharmaceuticals Incorporated (“Vertex,” “we,” “us” or “our”) is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases, with a focus on specialty markets. We have approved medicines for cystic fibrosis (“CF”), sickle cell disease (“SCD”), transfusion dependent beta thalassemia (“TDT”), and acute pain, and we continue to serially innovate and advance next-generation clinical and research programs in these areas. Our mid- and late-stage clinical pipeline includes programs across a range of modalities in additional serious diseases, including IgA nephropathy (“IgAN”), APOL1-mediated kidney disease, neuropathic pain, type 1 diabetes (“T1D”), primary membranous nephropathy (“pMN”), autosomal dominant polycystic kidney disease, and myotonic dystrophy type 1 (“DM1”). Our marketed CF medicines are ALYFTREK (vanzacaftor/tezacaftor/deutivacaftor), which was approved by the U.S. Food and Drug Administration (“FDA”) in December 2024, TRIKAFTA/KAFTRIO (elexacaftor/tezacaftor/ivacaftor and ivacaftor), SYMDEKO/SYMKEVI (tezacaftor/ivacaftor and ivacaftor), ORKAMBI (lumacaftor/ivacaftor) and KALYDECO (ivacaftor). CASGEVY (exagamglogene autotemcel), our ex-vivo, non-viral CRISPR/Cas9-based gene-editing therapy for severe SCD and TDT, is approved in the United States (“U.S.”) and across multiple geographies including Europe, Canada, and the Middle East. CASGEVY was initially approved by the FDA in December 2023. In January 2025, the FDA approved JOURNAVX (suzetrigine), our first-in-class, oral pain signal inhibitor that is highly selective for voltage-gated sodium channel NaV1.8, for the treatment of moderate-to-severe acute pain in adults. Basis of Presentation Basis of Presentation The accompanying consolidated financial statements, which have been prepared in accordance with accounting principles generally accepted in the U.S. (“U.S. GAAP”), reflect the operations of Vertex and our wholly owned subsidiaries. All material intercompany balances and transactions have been eliminated. We operate in one segment, pharmaceuticals. All material intercompany balances and transactions have been eliminated. We operate in one Please refer to Note Q, “Segment Information,” for enterprise-wide disclosures regarding our revenues, major customers, significant segment expenses, and long-lived assets by geographic area. Use of Estimates Use of Estimates The preparation of consolidated financial statements in accordance with U.S. GAAP requires us to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of our consolidated financial statements, and the amounts of revenues and expenses during the reported periods. We base our estimates on historical experience and various other assumptions, including in certain circumstances future projections that we believe to be reasonable under the circumstances. Actual results could differ from those estimates. Changes in estimates are reflected in reported results in the period in which they become known. Revenue Recognition Revenue Recognition We recognize revenue when a customer obtains control of promised goods or services. We record the amount of revenue that reflects the consideration that we expect to receive in exchange for those goods or services. We apply the following five- step model to determine this amount: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) we satisfy each performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration to which we are entitled in exchange for the goods or services that we transfer to the customer. Once a contract is determined to be within the"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "SUMMARY OF RISK FACTORS",
      "prior_body": "Our business is subject to numerous risks and uncertainties, discussed in more detail in the following section. These risks include, among others, the following key risks:"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Our Business",
      "prior_body": "•If we are unable to successfully develop and commercialize additional products, our business could be materially harmed. •If we are unable to sustain and grow revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline. •If we are unable to successfully develop, obtain approval and commercialize treatments for acute and neuropathic pain, our business could be materially harmed. •If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed. •If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline. •If we discover safety issues with any of our products or if we fail to comply with continuing U.S. and applicable foreign regulations, commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed. •If physicians and patients do not accept our products, or if patients do not remain on treatment or comply with their prescribed dosing regimen, our product revenues would decline in future periods. •Cell and genetic therapies face increased scrutiny from the public and medical communities and commercial success will depend, in part, upon the acceptance of those communities."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Pricing of Our Products",
      "prior_body": "•Government and other third-party payors seek to contain costs of health care through legislative and other means. If they fail to provide coverage and adequate reimbursement rates for our products, our revenues will be harmed. •We may experience pricing pressure on our products, which could reduce our revenues and future profitability. •Current health care laws and regulations in the U.S. and future legislative or regulatory reforms to the U.S. health care system may affect our ability to commercialize our marketed products profitably. •We have experienced challenges commercializing products outside of the U.S., and our future revenues will be dependent on our ability to obtain adequate reimbursement for our products in ex-U.S. markets. •Insurance coverage and reimbursement of our cell or genetic therapies is uncertain."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Development and Clinical Testing of Our Products and Product Candidates",
      "prior_body": "•Our product candidates remain subject to clinical testing and regulatory approval, and our future success is dependent on our ability to successfully develop additional product candidates for both CF and non-CF indications. •If we are unable to obtain or are delayed in obtaining regulatory approval, we may incur additional costs, experience delays, or be unable to commercialize our product candidates. •If clinical trials are prolonged or delayed, our development timelines for the affected development program could be extended, our costs to develop the product candidate could increase and the competitive position of the product candidate could be adversely affected. •Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval. 33 33 33 •Enrollment for clinical trials for our cell and gene therapies may face additional and unique challenges and adverse developments associated with these clinical trials could result in action by regulatory bodies, including revised requirements for approval."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Government Regulation",
      "prior_body": "•If regulatory authorities interpret any of our conduct, including our marketing practices, as being in violation of applicable health care laws, including fraud and abuse laws, laws prohibiting false and misleading promotion, disclosure laws or other similar laws, we may be subject to civil or criminal penalties. •If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, penalties, sanctions, and fines that could have a material adverse effect on our business, financial condition, results of operations and growth prospects. •If our processes and systems are not compliant with regulatory requirements, we could be subject to restrictions on marketing our products or could be delayed in submitting regulatory filings seeking approvals for our product candidates. •The regulatory approval process for our cell and genetic therapies involves additional consultations with regulatory agencies, costs, and potentially longer timelines as compared to those for small molecules."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Supply, Manufacturing and Reliance on Third Parties",
      "prior_body": "•We may face manufacturing, supply, and distribution difficulties, among other challenges, delays, or interruptions, including at our third-parties. •We rely on third parties to conduct pre-clinical work, clinical trials and other activities, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such studies and/or trials or failing to satisfy regulatory requirements."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Business Development Activities",
      "prior_body": "•We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and product candidates. •Our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities. •We may not realize the anticipated benefits of existing or future acquisitions of businesses or technologies, and the integration following any such acquisition may disrupt our business and management."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Intellectual Property",
      "prior_body": "•If our patents do not protect our products and our products infringe third-party patents, we could be subject to litigation which could result in injunctions preventing us from selling our products, substantial damages, or circumvention of our patents by third parties. •Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes that are inherently costly and unpredictable. •We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Our Operations",
      "prior_body": "•If we fail to scale our operations to accommodate growth, our business may suffer. •A variety of risks associated with operating in foreign countries could materially adversely affect our business. •A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business. •If we fail to attract and retain skilled employees, our business could be materially harmed. •Failure to maintain our third-party relationships or challenges at or with these third parties could materially harm our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Risks Related to Financial Results and Holding Our Common Stock",
      "prior_body": "•Our stock price may fluctuate and our quarterly operating results are subject to significant fluctuation. •Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken or exposure to additional income tax liabilities could have a material impact on our future taxable income. 34 34 34"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If we are unable to successfully develop, obtain approval and commercialize treatments for acute and neuropathic pain, our business could be materially harmed.",
      "prior_body": "We believe that a portion of the value attributed to our company by investors is based on our approved and potential treatments for acute and peripheral neuropathic pain. JOURNAVX, which was approved in January 2025 for moderate-to-severe acute pain in adults, may not gain or maintain market acceptance among physicians and patients or other members of the medical community. In addition to the risks normally associated with launching a new branded product, JOURNAVX will need to compete, and obtain reimbursement from third-party payors, in an acute pain market that largely consists of low-cost generic drugs, including opioids, non-steroidal anti-inflammatory drugs, acetaminophen and local anesthetics. Similarly, if we are successful in developing and obtaining approval for suzetrigine in peripheral neuropathic pain, this product will face competition from generic anticonvulsant and antidepressant drugs. If we are not able to successfully develop and commercialize treatments for acute and peripheral neuropathic pain, our future net product revenues and cash flows will be adversely affected and our business could be materially harmed."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.",
      "prior_body": "We have invested significant resources in the development and commercialization of CASGEVY. While we have previously successfully commercialized several small molecule drugs, we have limited experience with the commercialization of cell and genetic therapies. Manufacturing and commercialization of CASGEVY is subject to similar risks and uncertainties as small molecules. In addition: •the manufacturing process for CASGEVY is more complex than the manufacturing processes for our small molecule medicines and we may encounter difficulties in the production of CASGEVY and ensuring that the product meets required specifications; •there are multiple steps along the CASGEVY patient treatment journey, many of which involve significant clinical complexities performed by third parties, including the collection of blood cells from patients, transfer of those cells to and from a manufacturing facility, and other procedures either before or after delivery of CASGEVY; •the commercial success of CASGEVY continues to depend in part on the medical community, patients, governments, and third-party or governmental payors accepting it as a medically useful, cost-effective, ethical, and safe, and providing adequate reimbursement; and •global market acceptance continues to be dependent in part on the prevalence and severity of side effects associated with the procedure by which CASGEVY is administered, including the prevalence and severity of any side effects resulting from the myeloablative preconditioning regime. In addition, there is actual and potential future competition for CASGEVY, including bluebird’s SCD gene therapy, LYFGENIA™, and its TDT gene therapy, ZYNTEGLO™, which are both approved in the U.S. If competing therapies are commercialized, or developed and then commercialized, more successfully by other companies as a treatment for people with SCD or TDT, our future net product revenues and cash flows will be adversely affected and our business could be materially harmed If we are not successful in commercializing CASGEVY, our business could be materially harmed."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline.",
      "prior_body": "A number of companies are seeking to identify and develop product candidates for the treatment of CF, SCD, TDT, pain, and other therapeutic areas we are targeting with our research and development activities. Our success in rapidly developing and commercializing our CF medicines may increase the resources that our competitors allocate to the development of potential competitive treatments. If one or more competing therapies are successfully developed as a treatment for people with CF, SCD, TDT, pain or any of the other disease areas we are currently targeting in our pipeline, our products and our net product revenues could face competitive pressures. If one or more competing therapies prove to be superior to our then-existing products and/or product candidates, our business could be materially adversely affected. 36 36 36 In addition, our business faces competition from major pharmaceutical and biotechnology companies possessing substantially greater financial resources than we possess, as well as from numerous smaller public and private companies, academic institutions, government agencies, public and private research organizations, and charitable venture philanthropy organizations that conduct research, seek patent protection, and/or establish collaborative arrangements for research, development, manufacturing, and commercialization. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of our competitors. Smaller and other early-stage companies also may prove to be significant competitors, particularly through collaborative arrangements with large and established companies. These third parties compete with us in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, our programs. Our products and any products that we develop in the future may not be able to compete effectively with marketed therapies or new therapies that may be developed by competitors. The risk of competition is particularly important to our company because substantially all of our revenues are related to the treatment of people with CF. There are many other companies developing products for the same patient populations that we are pursuing. To compete successfully in these areas, we must demonstrate improved safety, efficacy and/or tolerability, ease of manufacturing, and gain and maintain market acceptance over competing products."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If physicians and patients do not accept our products, or if patients do not remain on treatment or comply with their prescribed dosing regimen, our product revenues would decline in future periods.",
      "prior_body": "Our approved products may not gain or maintain market acceptance among physicians and patients or other members of the medical community. Effectively marketing our products and any of our product candidates or investigational therapies, if approved, requires substantial efforts, both prior to launch and after approval. Physicians may elect not to prescribe or recommend our therapies, and patients may elect not to take them or receive them or they may discontinue use of our products after initiation of treatment, for a variety of reasons including: •prevalence and severity of adverse side effects; •lack of reimbursement availability from third-party payors, including governmental entities; •lower demonstrated efficacy, safety and/or tolerability compared to alternative treatment methods; •lack of cost-effectiveness; •a decision to wait for the approval of other therapies in development that have significant perceived advantages over our product; •inconvenience of, or burdens associated with, administration or treatment; •limitations or warnings contained in the labeling; •the timing of market introduction of our product as well as competitive products; •other potential advantages of alternative treatment methods; and •inadequate sales, marketing and/or distribution support. If our medicines fail to achieve or maintain market acceptance, we may not be able to generate significant revenues in future periods."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Cell and genetic therapies face increased scrutiny from the public and medical communities and commercial success will depend, in part, upon the acceptance of those communities.",
      "prior_body": "There is some degree of uncertainty as to whether cell and gene therapy treatments will continue to gain the acceptance of the public or the medical community. The commercial success of cell and gene therapy treatments, including CASGEVY, will depend, in part, on the acceptance of physicians, patients, and third-party payors of gene therapy products in general, and our product candidates in particular, as medically necessary, cost-effective and safe. In particular, our success will depend upon physicians prescribing our therapies in lieu of existing treatments they are already familiar with and for which greater clinical data may be available. Moreover, physicians and patients may delay acceptance of cell and gene therapies until the therapies have been on the market for a certain amount of time. In addition, medical centers, including authorized treatment centers, that administer procedures accompanying treatment could experience capacity constraints, and these centers are subject to competing priorities that could delay patient access to procedures associated with cell and gene therapy products. Negative public opinion or more restrictive government regulations may delay or impair the successful commercialization of, and demand for, cell and gene therapies."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Government and other third-party payors seek to contain costs of health care through legislative and other means. If they fail to provide coverage and adequate reimbursement rates for our products, our revenues will be harmed.",
      "prior_body": "Sales of our products depend in part upon the availability of reimbursement from third-party payors. Third-party payors include government health programs such as Medicare and Medicaid in the U.S. and the national health care systems in ex-U.S. markets, managed care providers, private health insurers and other organizations. The trend in the health care industry is cost containment, and efforts of third-party payors to contain or reduce health care costs may adversely affect our ability to establish or maintain appropriate prices for our products or any drugs that we may develop and commercialize. 38 38 38 In the U.S., there have been, and we expect that there will continue to be, a number of federal and state proposals to implement governmental controls that are similar to those that currently exist in Europe. For example, the Affordable Care Act (“ACA”) required manufacturers of Medicare Part D brand name drugs to provide discounts on those drugs to Medicare Part D beneficiaries during the coverage gap; increased the rebates paid by pharmaceutical companies to state Medicaid programs on drugs covered by Medicaid; and imposed an annual fee, which increases annually, on sales by branded pharmaceutical manufacturers. Additionally, private payors, including health maintenance organizations and pharmacy benefit managers in the U.S., are adopting more aggressive utilization management techniques and are increasingly applying restrictive plan designs that can impact patients and manufacturers, and they continue to push for significant discounts and rebates from manufacturers. On August 16, 2022, the IRA was enacted. Among other things, the IRA establishes a Drug Price Negotiation Program, under which the government may negotiate maximum fair prices for certain drugs covered by Medicare that do not have generic or biosimilar competition. The first set of maximum fair prices will be effective in 2026. Certain products are excluded from the negotiation program including drugs that have a single orphan drug designation and that are not approved for any other orphan or non-orphan diseases or conditions. We cannot predict with certainty whether there will be future legislative changes to the scope of these exclusions or how they will affect future drugs that we may develop and commercialize. The law also requires manufacturers to pay a rebate to Medicare if the price of a Medicare drug (under both Part B and Part D) increases faster than the rate of inflation and redesigns the Part D benefit. Starting in 2025, manufacturers of brand drugs and biologics will be required to provide a 10% discount during the initial phase and a 20% discount during the catastrophic phase of the Part D benefit. The IRA continues a trend in the U.S. toward reducing drug prices and limiting spending by the federal health care programs on drugs. We expect that this law will affect our business once fully implemented, and it is possible that other legislative updates will have an adverse impact on our revenue. The IRA also requires the Secretary of the Department of Health and Human Services (the “Secretary”) to issue program guidance on numerous areas associated with implementation of the law’s requirements, including for drug price negotiation and inflation rebates. While CMS has issued guidance covering the first two years of the program (2026 and 2027), we do not know with certainty what guidance will apply in future years or how such guidance will affect our business. It is possible the U.S. Congress or administration may take further actions to address health care costs and access to medicine, and specifically address coverage and reimbursement of cell and gene therapies. For example, the Center for Medicare and Medicaid Innovation (“CMMI”) was directed to consider new healthcare payment and delivery models that would lower drug costs and promote access to innovative drug therapies for Medicare and Medicaid beneficiaries. In February 2023, the U.S. Administration addressed access for cell and gene therapies in diseases such as SCD through the CMS program known as The Cell and Gene Therapy Access Model (“CGT Access Model”). The CGT Access Model was designed to provide an opportunity to accelerate and enhance broad Medicaid access for eligible patients across all 50 U.S. states by allowing state Medicaid agencies to delegate authority to CMS to coordinate and facilitate outcomes-based payment arrangements (“OBAs”) with cell and gene therapy manufacturers, such as ours. In 2024, we reached an agreement with CMS to expand access by participating in the CGT Access Model for SCD to benefit Medicaid beneficiaries. States may begin participating in the Cell & Gene Therapy Access Model on a rolling-basis, between January 2025 and January 2026. In January 2025, President Trump repealed Executive Order 14087, which had directed CMS to consider innovative pricing models, ultimately leading to the CGT Access Model. The rescission currently does not appear to impact our agreement with CMS or CMS’ authority to proceed with the CGT Access Model; however, any discontinuation of the CGT Access Model, or CMS’ termination of our agreement to participate in the model in the future, could impact access to CASGEVY. Third-party payors throughout the world also have been attempting to control drug spending in light of global economic pressures. In reimbursement negotiations, many payors are requesting price discounts and caps on total expenditures and limiting both the types and variety of drugs that they will cover if they are not able to secure them. Some payors restrict reimbursement of drugs through implementing utilization management controls. As part of these negotiations, many ex-U.S. government payors also are requiring companies to establish product cost-effectiveness as a condition of reimbursement. These cost-effectiveness reviews may overlook many of the benefits provided by innovative medicines, and for the most part, have not taken into account the specific circumstances of products that treat rare diseases. This has led to conclusions that certain medicines, including our products in certain jurisdictions, are not cost-effective. As a result, certain countries have declined to reimburse, or delayed their reimbursement of, some of our products. Although not mandated in the U.S., various organizations have started advocating for cost-effectiveness analyses in the U.S. as well as value-based contracting in which the amount of reimbursement for a product is based on patient outcomes and other clinical or economic metrics related to the performance of such product. If U.S. payors were to adopt such assessments and make negative coverage determinations or utilize value-based contracts that result in penalties to, or lower rates of, reimbursement, it could adversely affect our product 39 39 39 revenues. Our business would be materially adversely affected if we are not able to obtain or maintain coverage and reimbursement of our products from third-party payors on a broad, timely, or satisfactory basis, or if such coverage is subject to overly broad or restrictive utilization management controls. The increasing availability and use of innovative specialty pharmaceuticals for rare or other diseases or conditions, combined with their higher cost as compared to other types of pharmaceutical products, is generating significant third-party payor interest in developing cost-containment strategies targeted to this sector. Government regulations in both U.S. and ex-U.S. markets could further limit the prices that can be charged for our products, including for those with broader patient populations, and may limit our commercial opportunity. The increasing use of cost-effectiveness assessments in markets around the world and the financial challenges faced by many governments may lead to significant adverse effects on our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We may experience pricing pressure on our products, which could reduce our revenues and future profitability.",
      "prior_body": "There also has been an increase in state legislation and regulations related to drug pricing and drug pricing transparency. In the U.S., various states, including Nevada, Maryland, Louisiana, New York, California, Washington, Massachusetts, New Jersey, Connecticut, Vermont, New Hampshire, Utah, Minnesota, Oregon, Colorado, New Mexico, Virginia, Maine, Texas, North Dakota, West Virginia, Florida, and New Jersey have passed legislation requiring companies to disclose extensive information relating to drug prices, drug price increases, and spending on research, development, and marketing, among other things. Although it is not always clear what states will do with the collected information, some laws were designed to obtain additional product discounts. Additionally, certain states have enacted laws establishing Prescription Drug Affordability Boards (“PDABs”). Some state PDABs either have the authority or have defined a pathway where they may be granted the authority to establish upper payment limits for prescription drugs, including Colorado, Maryland, Washington, and Minnesota. Under the Washington law, the PDAB cannot select for an affordability review drugs that are solely for the treatment of an orphan-designated disease or condition. In August 2023, the Colorado PDAB selected five drugs for an affordability review, including TRIKAFTA; later that year, it found TRIKAFTA to be not unaffordable, and thus not eligible for an upper payment limit. We cannot, however, predict whether future reviews by the Colorado PDAB, or any other PDAB, will come to the same conclusion about TRIKAFTA or any of our other therapies, or the amount of any potential upper payment limit. We may continue to see more state action requiring additional disclosures or other actions. In addition, we could see increased federal activity related to drug pricing and transparency requiring disclosures or other actions instead of, or in addition to, state requirements. Similar initiatives also are occurring in, or being considered by, some of our ex-U.S. markets, including Italy and Brazil. Additional state actions, including the importation of drugs from other countries, also may affect the availability and accessibility of our medicines. For example, on January 5, 2024, the FDA authorized Florida’s Agency for Health Care Administration’s drug importation program under section 804 of the Federal Food, Drug, and Cosmetic Act, which eventually would allow Florida to import certain prescription drugs from Canada. The importation of drugs from Canada or other countries that potentially could compete with our medicines could create increased pressure on our revenue and profitability. Complying with these laws can be expensive and requires significant personnel and operational resources. Furthermore, any additional required discounts would adversely affect the pricing of, and revenues from, our products. Finally, while we seek to comply with all statutory and regulatory requirements, we face increased enforcement activity by the U.S. federal government, state governments, and private payors against pharmaceutical and biotechnology companies for pricing and reimbursement-related issues as well as inquiries from the U.S. Congress. Other federal activities seeking to specifically address drug pricing and reimbursement include: •rulemaking related to importation of prescription drugs from Canada, as well as guidance related to importation of prescription drugs from other foreign countries; •attempts to establish reference pricing for certain physician-administered drugs; •executive orders relating to drug pricing that are intended to broadly impact the pharmaceutical industry; •changes to the federal anti-kickback statute safe harbors that eliminate anti-kickback statute discount safe harbor protection for certain manufacturer rebate arrangements; and 40 40 40 •legislation relating to drug pricing, including enhanced transparency measures into drug pricing. We expect government scrutiny over drug pricing, reimbursement, and distribution to continue. Potential future government regulation of drug prices or reimbursement creates uncertainties about our portfolio and could have a material adverse effect on our operations. Moreover, antitrust and/or competition laws are increasingly being used to scrutinize pricing on high-value medicines and entities involved in drug distribution or reimbursement, including some with whom we do business. Defending against an antitrust or competition claim can be expensive and requires significant personnel and operational resources, may ultimately lead to a reduction in the prices of our products, and can ultimately result a material adverse effect on profitability and our business overall. Additionally, governmental efforts to pursue compulsory licensing, including the pursuit of so-called “march in” rights, could affect our pricing strategy and result in an adverse impact on our revenue."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Current health care laws and regulations in the U.S. and future legislative or regulatory reforms to the U.S. health care system may affect our ability to commercialize our marketed products profitably.",
      "prior_body": "The U.S. government, individual states and some foreign jurisdictions also have been aggressively pursuing legislative and regulatory reforms that could affect our ability to sell products. For example, in the U.S., there have been federal legislative and administrative efforts to repeal, substantially modify, or invalidate some or all of the provisions of the ACA, which could affect coverage and payment for medicines. The federal government additionally has proposed and enacted legislation leading to aggregate reductions of Medicare payments to providers, which ultimately could affect utilization of medicines. Other reforms include the Bipartisan Budget Act of 2018, which contained various provisions that affect coverage and reimbursement of drugs, including an increase in the discount that manufacturers of Medicare Part D brand name drugs must provide to Medicare Part D beneficiaries during the coverage gap from 50% to 70%. Under the IRA, the coverage gap phase and the associated coverage gap discount program will be eliminated after the 2024 plan year. Starting in 2025, there will be a new Part D manufacturer discount program, which requires a 10% discount in the initial phase and a 20% discount in the catastrophic phase of the benefit. The IRA also authorizes the government to negotiate maximum fair prices for certain Medicare drugs. It also establishes mandatory rebates for Part B and Part D drugs with prices that increase faster than inflation. These new laws or any other similar laws introduced in the future may result in additional reductions in Medicare and other health care funding, which could negatively affect our customers and accordingly, our financial operations. Moreover, payment methodologies may be subject to changes in health care legislation and regulatory initiatives. For example, CMS may develop new payment and delivery models, such as bundled payment models. Adoption of new health care reform legislation at the federal or state level could affect demand for, or pricing of, our products or product candidates if approved for sale. We cannot, however, predict the ultimate content, timing, or effect of any health care reform legislation or action, or its impact on us, including increased compliance requirements and costs, all of which may adversely affect our future business, operations, and financial results."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We have experienced challenges commercializing products outside of the U.S., and our future revenues will be dependent on our ability to obtain adequate reimbursement for our products in ex-U.S. markets.",
      "prior_body": "In most ex-U.S. markets, the pricing and reimbursement of therapeutic and other pharmaceutical products is subject to governmental control and government authorities are making greater efforts to limit or regulate the price of drug products. The reimbursement process in ex-U.S. markets can take a significant time to conclude and reimbursement decisions are made on a country by country or region by region basis. Further, many ex-U.S. governments are introducing new legislation focusing on cost containment measures in the pharmaceutical industry. The final form of these laws and the relevant practical application is unknown at this time, but may lead to lower prices, paybacks or other forms of discounts or special taxes. Our CF medicines and CASGEVY treat life-threatening conditions and address relatively small patient populations, and our research and development programs are primarily focused on developing medicines to treat similar diseases. Both government and private payors are targeting these types of therapies, in some cases refusing to pay for them. We have experienced challenges in obtaining timely reimbursement for our products in various countries outside the U.S. Our future product revenues, including from TRIKAFTA/KAFTRIO, ALYFTREK, and CASGEVY, depend on, among other things, our ability to maintain reimbursement in ex-U.S. markets for our products. There is no assurance that coverage and reimbursement will be available outside of the U.S. for our approved or future therapies and, even if it is available, whether 41 41 41 the timing or the level of reimbursement will be sufficient to allow us to market them. Adverse pricing limitations or a delay in obtaining coverage and reimbursement would decrease our future net product revenues and harm our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Insurance coverage and reimbursement of cell and genetic therapies is uncertain.",
      "prior_body": "There is uncertainty related to the insurance coverage and reimbursement of cell or genetic therapies, including those gene therapies that are potential one-time treatments. While coverage has not been a significant obstacle in the launch of CASGEVY, it is difficult to predict what third party payors, including U.S. or ex-U.S. governments or private insurance companies, will decide with respect to reimbursement for the other novel cell and genetic therapies in our pipeline. Additionally, reimbursement rates for cell and genetic therapies approved before ours could create an adverse environment for reimbursement of any therapies we ultimately commercialize. The administration of our products may require procedures for the collection of cells from patients, followed by other procedures either before or after delivery of the cell or genetic therapy. The manner and level at which reimbursement is provided for these services also is important. Inadequate reimbursement for such services may discourage physicians and hospitals from recommending our cell and genetic therapies and impair our ability to market or sell such therapies. Moreover, the treatment center network for our products and growth of such network could also impact uptake and necessitate out-of-state access for some beneficiaries if an authorized treatment center is not available within their home state, which could result in further underpayment from out-of-state Medicaid programs."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If we are unable to obtain or are delayed in obtaining regulatory approval, we may incur additional costs, experience delays, or be unable to commercialize our product candidates.",
      "prior_body": "The time required to complete clinical trials and to satisfy the FDA and other countries’ regulatory review processes is uncertain and typically takes many years. Our analysis of data obtained from nonclinical and clinical activities is subject to confirmation and interpretation by regulatory authorities, which could delay, limit or prevent regulatory approval. We may encounter unanticipated delays or increased costs due to government regulation from future legislation or administrative action or changes in governmental policy during the period of drug development, clinical trials and governmental regulatory review. We also may be unable to obtain or be delayed in obtaining regulatory approval due to competition developments that impact our regulatory pathways. We may seek a Fast Track, Priority Review, Breakthrough Therapy, and/or RMAT designation for some of our product candidates. Product candidates that receive one or more of these designations may be eligible for, among other things, a priority regulatory review. Each of these designations is within the discretion of the FDA. Accordingly, even if we believe one of our product candidates meets the criteria for Fast Track, Priority Review, Breakthrough Therapy and/or RMAT designation, the FDA may disagree and instead determine not to make such designation. The receipt of one or more of these designations for a product candidate does not guarantee a faster development process, review or approval compared to products developed or considered for approval under conventional FDA procedures and does not assure ultimate approval by the FDA. In addition, even if one or more of our products or product candidates qualifies for Fast Track, Priority Review, Breakthrough Therapy and/or RMAT designation, the FDA may later decide to withdraw such designation if it determines that the product or product candidate no longer meets the conditions for qualification. Any failure to obtain regulatory approvals for a product candidate would prevent us from commercializing that product candidate. Any delay in obtaining required regulatory approvals could materially adversely affect our ability to successfully commercialize a product candidate. Furthermore, any regulatory approval to market a product may be subject to limitations that we do not expect including with respect to the indicated uses for which we may market the product or required conditions of use. Any such limitations could reduce the size or demand of the market for the drug. 43 43 43 We also are subject to numerous foreign regulatory requirements governing the conduct of clinical trials, manufacturing and marketing authorization, pricing and third-party reimbursement. Non-U.S. jurisdictions have different approval procedures than those required by the FDA, and these jurisdictions may impose additional testing requirements for our product candidates. The foreign regulatory approval process includes all of the risks associated with the FDA approval process described above, as well as risks attributable to the satisfaction of foreign requirements. Approval by the FDA does not ensure approval by regulatory authorities outside the U.S. and approval by a foreign regulatory authority does not ensure approval by the FDA. In addition, although the FDA may accept data from clinical trials conducted outside the U.S., acceptance of this data is subject to conditions imposed by the FDA. For example, the clinical trial must be well designed and conducted and performed by qualified investigators in accordance with ethical principles. The trial population also must adequately represent the U.S. population, and the data must be applicable to the U.S. population and U.S. medical practice in ways that the FDA deems clinically meaningful. In addition, while these clinical trials are subject to applicable local laws, FDA acceptance of the data will depend on its determination that the trials also complied with all applicable U.S. laws and regulations. If the FDA does not accept the data from any trial that we conduct outside the U.S., it would likely result in the need for additional trials, which would be costly and time-consuming and delay or permanently halt our development of the applicable product candidate."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If clinical trials are prolonged or delayed, our development timelines for the affected development program could be extended, our costs to develop the product candidate could increase and the competitive position of the product candidate could be adversely affected.",
      "prior_body": "We cannot predict whether or not we will encounter problems with any of our completed, ongoing or planned clinical trials that will cause us or regulatory authorities to delay or suspend clinical trials, or delay the analysis of data from our completed or ongoing clinical trials. Among the factors that could delay our development programs are: •ongoing discussions with the FDA or comparable foreign authorities regarding the scope or design of our clinical trials and the number of clinical trials we must conduct; •failure or delay in reaching agreement on acceptable terms with prospective contract research organizations (“CROs”) and clinical trial sites; •failure to add or delay in adding a sufficient number of clinical trial sites and obtaining institutional review board or independent ethics committee approval at each clinical trial site; •suspension or termination of clinical trials of product candidates for various reasons, including non-compliance with regulatory requirements; •clinical trial sites deviating from clinical trial protocol or dropping out of a clinical trial; •delays in enrolling volunteers or patients into clinical trials, including as a result of low numbers of patients that meet the eligibility criteria for the trial; •a lower than anticipated retention rate of volunteers or patients in clinical trials; •the need to repeat clinical trials as a result of unfavorable or inconclusive results, unforeseen complications in testing or clinical investigator error; •inadequate supply or deficient quality of product candidate materials or other materials necessary for the conduct of our clinical trials; •unfavorable FDA or foreign regulatory authority inspection and review of a manufacturing facility that supplied clinical trial materials or its relevant manufacturing records or a clinical trial site or records of any clinical or preclinical investigation; •unfavorable or inconclusive scientific results from clinical trials; •serious and unexpected treatment-related side-effects experienced by participants in our clinical trials or by participants in clinical trials being conducted by our competitors to evaluate product candidates with similar mechanisms of action or structures to therapies that we are developing; 44 44 44 •favorable results in testing of our competitors’ product candidates, or FDA or foreign regulatory authority approval of our competitors’ product candidates; or •action by the FDA or a foreign regulatory authority to place a clinical hold or partial clinical hold on a trial or compound or deeming the clinical trial conduct as problematic. For planning purposes, we estimate the timing of the accomplishment of various scientific, clinical, regulatory, and other product development goals, which we sometimes refer to as milestones. These milestones may include the commencement or completion of scientific studies and clinical trials and the submission of regulatory filings. From time to time, we publicly announce the expected timing of some of these milestones. All of these milestones are based on a variety of assumptions. The actual timing of these milestones can vary dramatically compared to our estimates, in many cases for reasons beyond our control. If we do not meet these milestones as publicly announced, the commercialization of our products may be delayed and the credibility of our estimates may be adversely affected and, as a result, our stock price may decline."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.",
      "prior_body": "Our ability to enroll patients in our clinical trials in sufficient numbers and on a timely basis is subject to a number of factors. Clinical trials are expensive and require significant operational resources. Delays in patient enrollment or unforeseen drop-out rates may result in increased costs and longer development times. The enrollment of patients further depends on many factors, including: •the proximity of patients to clinical trial sites; •the size of the patient population, the nature of the protocol, and the design of the clinical trial; •our ability to recruit clinical trial investigators with the appropriate competencies and experience; •the number of other clinical trials ongoing and competing for patients in the same indication; •our ability to obtain and maintain patient consents; •reporting of the preliminary results of any of our clinical trials; •the availability of effective treatments for the relevant disease and eligibility criteria for the clinical trial; •the risk that patients enrolled in clinical trials will drop out of the clinical trials before clinical trial completion; and •factors we may not be able to control, such as pandemics that may limit patients, principal investigators or staff or clinical site availability. We, our collaborators, the FDA, or other applicable regulatory authorities may suspend clinical trials of a product candidate at any time if we or they believe the healthy volunteers or patients participating in such clinical trials are being exposed to unacceptable health risks or for other reasons. Any such suspension could materially adversely affect the development of a particular product candidate and our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Enrollment for clinical trials for our cell and gene therapies may face additional and unique challenges and adverse developments associated with these clinical trials could result in action by regulatory bodies, including revised requirements for approval.",
      "prior_body": "For cell and genetic therapy programs addressing rare genetic diseases with small patient populations, we may not be able to identify, recruit and enroll a sufficient number of patients, or those with required or desired characteristics, to complete our clinical studies in an adequate and timely manner. Additionally, patients may be unwilling to participate in our clinical trials because of concerns that cell and genetic therapies are unsafe or unethical, negative publicity from adverse safety events in the biotechnology or gene therapy industries, or for other reasons, including competitive clinical studies for similar patient populations. Moreover, adverse developments in clinical trials conducted by others of cell and genetic therapy products or products created using similar technology, or adverse public perception of the field of cell and genetic therapies, may cause the FDA and other regulatory bodies to revise the requirements for approval of any cell or genetic therapy product 45 45 45 candidates we may develop or limit the use of products utilizing technologies such as ours, either of which could materially harm our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If we fail to comply with our reporting and payment obligations under the Medicaid Drug Rebate Program or other governmental pricing programs in the U.S., we could be subject to additional reimbursement requirements, penalties, sanctions, and fines that could have a material adverse effect on our business, financial condition, results of operations and growth prospects.",
      "prior_body": "We participate in the Medicaid Drug Rebate Program, the 340B program, and a number of other federal and state government pricing programs in the U.S. to obtain coverage for our products by certain government health care programs. These programs require us to pay rebates or provide discounts to certain government payors or private purchasers in connection with our products when dispensed to beneficiaries of these programs. In some cases, such as with the Medicaid Drug Rebate Program, the rebates are based on pricing and rebate calculations that we report on a monthly and quarterly basis to the government agencies that administer the programs. The terms, scope and complexity of these government pricing programs may change. For example, regulations finalized in December 2020 created an alternative Medicaid rebate formula for “line extensions” of oral solid dosage forms. Moreover, in December 2020, CMS finalized changes to Medicaid Drug Rebate Program pricing calculations regarding the provision of co-payment assistance to patients that may be impacted by so-called accumulator programs operated by private insurers or pharmacy benefit managers. The portion of this rule dealing with manufacturer co-payment assistance was struck down by the U.S. District Court for the District of Columbia in May 2022 (and the deadline for an appeal has lapsed). In September 2024, CMS issued a final rule withdrawing the challenged accumulator adjustment regulations. The rule made significant changes to, among other things, penalties for misclassification and the definitions of a covered outpatient drug, internal investigation and market date, which may have an impact on our Medicaid rebate liability. Additionally, the expansion of the 340B Drug Discount Program through the ACA has increased the number of purchasers, known as covered entities, who are eligible for significant discounts on branded drugs. In general, covered entities distribute 340B drugs through their own in-house pharmacies. A growing number of covered entities have been contracting with retail and/or specialty pharmacies, known as contract pharmacies, to distribute 340B drugs. Manufacturers have begun to implement restrictions on covered entities that use contract pharmacies. Similarly, we limit hospital covered entities to contract with one contract pharmacy if the covered entity does not have an in-house outpatient pharmacy. Otherwise, hospital covered entities that have an in-house outpatient pharmacy are not permitted to use contract pharmacies. Our policy applies to our CF and pain products, and it does not apply to Federal grantees and hospitals and any covered entities in states that prohibit manufacturers from restricting covered entities from accessing 340B drugs through contract pharmacies. Certain states, including Arkansas, Kansas, Louisiana, Maryland, Minnesota, Mississippi, Missouri, and West Virginia, have passed laws to regulate the relationship between manufacturers and contract pharmacies. A number of manufacturers have filed lawsuits against these states. These and future changes to government pricing programs, laws, and regulations may have a material adverse impact on our revenue and operations. We also may have reimbursement obligations or be subject to penalties if we fail to provide timely and accurate information to the government, pay the correct rebates, or offer the correct discounted pricing. Changes to the price reporting or rebate requirements of these programs would affect our obligations to pay rebates or offer discounts. For example, the removal of the current statutory 100% of Average Manufacturer Price per-unit cap on Medicaid rebate liability for single source and innovator multiple source drugs, effective as of January 1, 2024, under the American Rescue Plan Act of 2021, may affect the prices that are required to be charged to covered entities under the 340B Drug Discount Program. Additionally, the IRA requires manufacturers to pay rebates for Medicare Part B and Part D drugs with prices that increase 47 47 47 faster than the rate of inflation. Responding to current and future changes to these and other Medicaid Drug Rebate Program requirements may reduce our net revenues and the complexity of compliance, will be time-consuming, and could have a material adverse effect on our results of operations."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If our processes and systems are not compliant with regulatory requirements, we could be subject to restrictions on marketing our products or could be delayed in submitting regulatory filings seeking approvals for our product candidates.",
      "prior_body": "We have a number of regulated processes and systems that are required both prior to and following approval of our drugs and product candidates. These processes and systems are subject to continual review and periodic inspection by the FDA and other regulatory bodies. In addition, the clinical research organizations and other third parties that we work with in our non-clinical studies and clinical trials and our oversight of such parties are subject to similar reviews and periodic inspection by the FDA and other regulatory bodies. If compliance issues are identified at any point in the development and approval process, we may experience delays in filing for regulatory approval for our product candidates, or delays in obtaining regulatory approval after filing, if at all. Any later discovery of previously unknown problems or safety issues with approved products or manufacturing processes, or failure to comply with regulatory requirements, may result in restrictions on such products or manufacturing processes, withdrawal of products from the market, the imposition of civil or criminal penalties or a refusal by the FDA and/or other regulatory bodies to approve pending applications for marketing approval of new products or supplements to approved applications, any of which could have a material adverse effect on our business. In addition, we are party to agreements that transfer responsibility for complying with specified regulatory requirements, such as filing and maintenance of marketing authorizations and safety reporting or compliance with manufacturing requirements, to our collaborators and third-party manufacturers. If our collaborators or third-party manufacturers do not fulfill these regulatory obligations, any products for which we or they obtain approval may be subject to later restrictions on manufacturing or sale, which could have a material adverse effect on our business."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "The regulatory approval process for our cell or genetic therapies involves additional consultations with regulatory agencies, costs, and potentially longer timelines as compared to those for small molecules.",
      "prior_body": "As we advance our cell and genetic therapy product candidates, we will be required to consult with various regulatory authorities, and we must comply with all applicable laws, rules, and regulations, which may change from time to time, including during the course of development of our cell and genetic therapy product candidates. If we fail to do so, we may be required to delay or discontinue the clinical development of certain of our cell and genetic therapy product candidates. These additional processes may result in a review and approval process that is longer than we otherwise would have expected. Even if we comply with applicable laws, rules, and regulations, and even if we maintain close coordination with the applicable regulatory authorities with oversight over our cell and genetic therapy product candidates, our development programs may experience delays or fail to succeed. Delay or failure to obtain, or unexpected costs in obtaining, the regulatory approval necessary to bring a potential cell or genetic therapy product to market would materially adversely affect our business, financial condition, results of operations and prospects. The regulatory approval process and clinical trial requirements for cell and genetic therapies can be more expensive and take longer than for other, better known or more extensively studied product candidates, and regulatory requirements governing cell and genetic therapy products have changed frequently and may continue to change in the future. For example, the FDA established the Office of Tissues and Advanced Therapies within its Center for Biologics Evaluation and Research (“CBER”) to consolidate the review of cell therapies and related products, and the Cellular, Tissue and Gene Therapies Advisory Committee to advise CBER on its review. These and other regulatory review agencies, committees and advisory groups, and the requirements and guidelines they promulgate, may lengthen the regulatory review process, require us to perform additional preclinical studies or clinical trials, increase our development costs, lead to changes in regulatory positions and interpretations, delay or prevent approval and commercialization of these treatment candidates or lead to significant post-approval limitations or restrictions."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.",
      "prior_body": "Our research and development efforts involve the regulated use of hazardous materials, chemicals, and various controlled and radioactive compounds. Although we believe that our safety procedures for handling and disposing of these materials comply with the standards prescribed by state, federal and foreign regulations, the risk of loss of, or accidental contamination 49 49 49 or injury from, these materials cannot be eliminated. If an accident occurs, we could be held liable for resulting damages, which could be substantial. We also are subject to numerous environmental, health, and workplace safety laws and regulations, including those governing laboratory procedures, exposure to blood-borne pathogens, and the handling of biohazardous materials. Although we maintain workers’ compensation insurance to cover us for costs we may incur due to injuries to our employees resulting from the use of these materials, this insurance may not be sufficient to cover all potential liabilities. We maintain insurance to cover pollution conditions or other extraordinary or unanticipated events relating to our use and disposal of hazardous materials that we believe is appropriate based on the small amount of hazardous materials we generate. Additional federal, state and local laws and regulations affecting our operations may be adopted in the future. We may incur substantial costs to comply with, and substantial fines or penalties if we violate, any of these laws or regulations."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We rely on third parties to conduct pre-clinical work, clinical trials and other activities, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of such studies and/or trials or failing to satisfy regulatory requirements.",
      "prior_body": "We rely on third parties such as CROs to help manage certain pre-clinical work and our clinical trials and on medical institutions, clinical investigators, and clinical research organizations such as the Therapeutic Development Network, which is primarily funded by the Cystic Fibrosis Foundation, to assist in the design and review of, and to conduct our clinical trials, including enrolling qualified patients. In addition, we engage third party contractors to support numerous other research, commercial and administrative activities. Our reliance on these third parties for clinical development activities reduces our control over these activities but does not relieve us of our responsibilities. For example, we remain responsible for ensuring that each of our clinical trials is conducted in accordance with the general investigational plan and protocols for the clinical trial. Moreover, the FDA and other relevant regulatory authorities around the world require us to comply with standards, commonly referred to as good laboratory practices and good clinical practices, for conducting, recording and reporting the results of pre-clinical and clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. Such standards, particularly with respect to newer cell and genetic therapies, will continue to evolve and subject us and third parties to new or changing requirements. If these third parties do not successfully carry out their contractual duties or meet expected deadlines, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue the activities, it may result in a delay of the affected clinical trial, product development program or applicable activity. If clinical trials are not conducted in accordance with our contractual expectations or regulatory requirements, action by regulatory authorities might significantly and adversely affect the conduct or progress of these clinical trials or in specific circumstances might result in a requirement that a clinical trial be redone. Accordingly, our efforts to obtain regulatory approvals for and commercialize our product candidates could be delayed. In addition, failure of any third-party contractor to conduct activities in accordance with our expectations, could adversely affect the relevant research, development, commercial or administrative activity. 51 51 51"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and product candidates.",
      "prior_body": "The risks that we face in connection with our current collaborations, including with CRISPR, Moderna, Entrada, and Zai, and any future collaborations, include the following: •Collaborators may develop and commercialize, either alone or with others, drugs or therapies that are similar to or competitive with the products or product candidates that are the subject of their collaborations with us. •Disagreements with collaborators, including disagreements over proprietary rights, contract interpretation or the preferred course of development, might cause delays or termination of the research, development or commercialization of product candidates, might lead to additional responsibilities or costs for us with respect to product candidates, or might result in litigation or arbitration. Any such disagreements would divert management attention and resources and would be time-consuming and expensive. •Collaborators may not properly maintain or defend our intellectual property rights or may use our proprietary information in such a way as to invite litigation that could jeopardize or invalidate our intellectual property or proprietary information or expose us to potential litigation. •Collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability. •Investigations and/or compliance or enforcement actions against a collaborator, which may expose us to indirect liability as a result of our partnership with such collaborator. If a collaborator were to be involved in a business combination with a third party, it might de-emphasize or terminate the development or commercialization of any product candidate licensed to it by us. If one of our collaborators terminates its agreement with us, we may find it more difficult to attract new collaborators and our perception in the business and financial communities could be harmed. Moreover, as part of our ongoing strategy, we may seek additional collaborative arrangements for certain of our development programs and/or seek to expand existing collaborations to cover additional commercialization and/or development activities. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA, EMA or other regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products, the existence of uncertainty with respect to our ownership of the applicable intellectual property, which can exist if there is a challenge to such ownership without regard to the merits of the challenge, and industry and market conditions generally. No assurance can be given that any efforts we make to seek additional collaborative arrangements will be successfully completed on a timely basis or at all."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Our ability to execute on our long-term strategy depends in part on our ability to engage in transactions and collaborations with other entities that add to our pipeline or provide us with new commercial opportunities.",
      "prior_body": "To achieve our long-term business objectives, we seek to license or acquire products, product candidates and other technologies that have the potential to complement our ongoing research and development efforts, access emerging technologies and license or acquire pipeline assets. These transactions may be similar to prior transactions, may be structured differently than prior transactions, or may involve larger transactions or later-stage assets. We have faced and will continue to face significant competition for the acquisition of rights to these types of products, product candidates and other technologies from a variety of other companies, some of which have significantly more financial resources and experience in business development activities than we have. In addition, investors and non-profit organizations may be willing to provide capital to the companies that control additional products, product candidates or technologies, which may provide incentives for companies to advance these products, product candidates or technologies independently. Also, the cost of acquiring, in-licensing or otherwise obtaining rights to such products, product candidates or other technologies has grown dramatically in recent years and may be at levels that we cannot afford or that we believe are not justified by market potential. As a result, we 52 52 52 may not be able to acquire, in-license or otherwise obtain rights to additional products, product candidates or other technologies on acceptable terms or at all."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We may not realize the anticipated benefits of existing or future acquisitions of businesses or technologies, and the integration following any such acquisition may disrupt our business and management.",
      "prior_body": "Effectively integrating acquired businesses, technologies and exclusive licenses is challenging. We may not realize the benefits anticipated from our external innovation transactions, including the value of Alpine’s pipeline and candidates, which could adversely affect our business and financial condition. Achieving the anticipated benefits of any transaction and successfully integrating acquired businesses or technologies, including Alpine, involves a number of risks, including: •failure to successfully develop and commercialize the acquired products, product candidates or technologies or to achieve other strategic objectives; •delays or inability to progress preclinical programs into clinical development or unfavorable data from clinical trials evaluating the acquired or licensed product or product candidates; •difficulty in integrating the products, product candidates, technologies, business operations and personnel of an acquired asset or company; •disruption of our ongoing business and distraction of our management and employees from daily operations or other opportunities and challenges; •the potential loss of key employees of an acquired company; •entry into markets in which we have no or limited direct prior experience or where competitors in such markets have stronger market positions; •potential failure of the due diligence processes to identify significant problems, liabilities or challenges of an acquired company, or acquired or licensed products, product candidate or technology, including problems, liabilities or challenges with respect to intellectual property, clinical or non-clinical data, safety, accounting practices, employee, or third-party relations and other known and unknown liabilities; •liability for activities of the acquired company or licensor before the acquisition or license, including intellectual property infringement claims, violations of laws, commercial disputes, tax liabilities, and other known and unknown liabilities; •exposure to litigation or other claims in connection with, or inheritance of claims or litigation risk as a result of an acquisition or license, including claims from terminated employees, customers, former equity holders or other third parties; and •difficulties in the integration of the acquired company’s departments, systems, including accounting, human resource and other administrative systems, technologies, books and records, and procedures, as well as in maintaining uniform standards, controls, including internal control over financial reporting required by the Sarbanes-Oxley Act of 2002 and related procedures and policies. Acquisitions, licensing arrangements and other strategic transactions are inherently risky, and ultimately, if we do not complete an announced acquisition, collaboration or strategic transaction or integrate an acquired or licensed asset, business or technology successfully and in a timely manner, we may not realize the anticipated benefits of the strategic transaction. We may later incur impairment charges related to assets acquired in any such transaction. Moreover, relatively small changes in key assumptions and judgements may result in the recognition of significant intangible asset impairment charges, which could have a material adverse impact on our results of operations. Even if we achieve the long-term benefits associated with our strategic transactions, our expenses and short-term costs may increase materially and adversely affect our liquidity and short-term net income. Future strategic transactions could result in increased operating expenses, potentially dilutive issuances of equity securities, the incurrence of debt, the creation of contingent liabilities, impairment expenses related to goodwill, or impairment or amortization expenses related to other intangible assets, all of which could harm our financial condition. 53 53 53"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "If our patents do not protect our products or our products infringe third-party patents, we could be subject to litigation which could result in injunctions preventing us from selling our products, substantial damages, or circumvention of our patents by third parties.",
      "prior_body": "We own and/or control numerous issued patents and pending patent applications in the U.S., as well as counterparts in other countries. Our success will depend, in significant part, on our ability to obtain and defend U.S. and foreign patents covering our products, their uses and our processes, to preserve our trade secrets and to operate without infringing the proprietary rights of third parties. We cannot be certain that any patents will issue from our pending patent applications or, even if patents issue or have issued, that the issued claims will provide us with adequate protection against competitive products or otherwise be commercially valuable. U.S. and foreign patent applications typically are maintained in confidence for a period of time after they initially are filed with the applicable patent office. Consequently, we cannot be certain that we were the first to file patent applications on our products or product candidates or their use. If a third-party has an earlier filed patent application relating to our product or product candidates, their uses, or a similar invention, we may be unable to obtain an issued patent from our application. Due to evolving legal standards relating to the patentability, validity, and enforceability of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these patents, our ability to obtain, maintain and enforce patents is uncertain and involves complex legal and factual questions. We have many pending patent applications covering our products. These pending patent applications may not issue, and we may not receive any additional patents. The issuance of a patent is not conclusive as to its inventorship, scope, validity, or enforceability. Our patents may be challenged by third parties and certain of our patents have been challenged. This could result in the patent being deemed invalid, unenforceable or narrowed in scope, or the third party may circumvent any such issued patents, including through compulsory licensing mechanisms. When market exclusivity ends or if our patents are circumvented, generic versions of our medicines may be approved and marketed, which could cause substantial and rapid declines in the sales of our products. Our patents or patents we license might not contain claims that are sufficiently broad to prevent others from developing competing products. For instance, issued patents, or patents that may issue in the future, (i) relating to our small molecules may be limited to a particular molecule or molecules and may not cover similar molecules that have similar clinical properties, and (ii) relating to cell or genetic therapies may not cover similar technologies that would allow competitors to achieve similar results. Consequently, our competitors may independently develop competing products that do not infringe our patents or other intellectual property. The laws of many foreign jurisdictions do not protect intellectual property rights to the same extent as in the U.S. We, like many companies in our segment of the pharmaceutical industry, have encountered challenges in protecting and defending such rights in foreign jurisdictions. Difficulties or preclusion from protecting our intellectual property rights in foreign jurisdictions, including through compulsory licensing, could substantially harm our business. Because of the extensive time required for the discovery, development, testing and regulatory review of product candidates, it is possible that a patent may expire before a product candidate can be commercialized, or a patent may expire or remain in effect for only a short period following commercialization of such product candidate. This would result in a minimal or non-existent period of patent exclusivity. If our product candidates are not commercialized significantly ahead of the expiration date of any applicable patent, or if we have no patent protection on such product candidates, then, to the extent available we would rely on other forms of exclusivity, such as data exclusivity or orphan drug exclusivity."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Uncertainty over intellectual property in the pharmaceutical and biotechnology industry has been the source of litigation and other disputes that are inherently costly and unpredictable.",
      "prior_body": "There is considerable uncertainty within our industry about the validity, scope, and enforceability of many issued patents in the U.S. and elsewhere in the world, and, to date, the law and practice remains in flux both in the agencies that grant patents and in the courts. We cannot currently determine the ultimate scope and validity of patents which may be granted to third parties in the future or which patents might be asserted as being infringed by the manufacture, use and sale of our products. 54 54 54 There has been, and we expect that there may continue to be, significant litigation and other disputes in the pharmaceutical industry regarding patents and other intellectual property rights. Litigation, arbitrations, administrative proceedings, and other legal actions with private parties and governmental authorities concerning patents and other intellectual property rights may be protracted, expensive, and distracting to management. Competitors may sue us as a way of delaying the introduction of our products or to remove our products from the market. Any litigation, including litigation related to Abbreviated New Drug Applications (“ANDA”), litigation related to 505(b)(2) applications, interference proceedings to determine priority of inventions, derivations proceedings, inter partes review, oppositions to patents in foreign countries, litigation against our collaborators or similar actions, may be costly and time consuming and could harm our business. We expect that litigation may be necessary in some instances to determine the validity and scope of certain of our proprietary rights. Litigation may be necessary in other instances to determine the validity, scope or non-infringement of certain patent rights claimed by third parties to be pertinent to the manufacture, use or sale of our products. Ultimately, the outcome of such litigation could adversely affect the validity and scope of our patent or other proprietary rights, hinder our ability to manufacture and market our products, or result in the assessment of significant monetary damages against us that may exceed amounts, if any, accrued in our consolidated financial statements. On July 22, 2022, we filed a lawsuit against Lupin in the U.S. District Court for the District of Delaware alleging infringement of U.S. Patent Nos. 10,646,481 (“the ’481 patent”), 8,883,206 (“the ’206 patent”), 10,272,046 (“the ’046 patent”), and 11,147,770 (“the ’770 patent”). The lawsuit follows our receipt of a Notice Letter on June 9, 2022, advising that Lupin had submitted an ANDA to the FDA seeking approval to manufacture and market a generic version of KALYDECO granules in the U.S. The Notice Letter indicated that Lupin submitted a “Paragraph IV” certification to the FDA in which Lupin asserts that the ’481 patent, the ’206 patent, and the ’046 patent are invalid or would not be infringed by Lupin’s generic product. On February 28, 2023, U.S. Patent No. 11,564,916 (“the ‘916 patent”) was listed in the Orange Book as covering KALYDECO granules. By letter dated April 25, 2023, Lupin notified us that it had amended its ANDA to include a Paragraph IV certification with respect to the ’916 patent. On May 26, 2023, we filed a lawsuit against Lupin in the U.S. District Court for the District of Delaware alleging infringement of the ’916 patent. On October 11, 2023, U.S. Patent No. 11,752,106 (the “’106 patent”) was listed in the Orange Book as covering KALYDECO granules. By letter dated February 27, 2024, Lupin notified Vertex that it had amended its ANDA to include a Paragraph IV certification with respect to the ‘106 patent. On April 11, 2024, Vertex filed a lawsuit against Lupin in the U.S. District Court for the District of Delaware alleging infringement of the ‘106 patent. The Court subsequently entered a scheduling order, which consolidated the lawsuit asserting infringement of the ‘106 patent with the earlier filed lawsuits asserting infringement of the ‘481, ‘206, ‘046, ‘770, and ‘916 patents. A three-day trial is scheduled for September 15, 2025. Other than the ’770 patent, which was listed in the Orange Book on April 14, 2022, Lupin does not appear to challenge our other U.S. patents covering KALYDECO granules, the last of which expires on August 5, 2027. Therefore, regardless of the outcome of the litigation, Lupin cannot receive final approval of its ANDA before that date. We intend to vigorously enforce our intellectual property rights relating to KALYDECO granules and the ’481, ’206, ’046, ’770, ’916, and ’106 patents. CRISPR has licensed certain rights to a worldwide patent portfolio that covers various aspects of the CRISPR/Cas9 editing platform technology including, for example, compositions of matter and methods of use in targeting or cutting DNA from Dr. Emmanuelle Charpentier, one of the named inventors of this patent portfolio. The patent portfolio also has named inventors who assigned their rights to the CVC Group. For example, in connection with their collaboration, Novartis and Intellia Therapeutics, Inc. have reportedly obtained a license to this patent portfolio in certain fields. Both the CVC Group and Broad have obtained granted patents that purport to cover aspects of CRISPR/Cas9 editing platform technology. Patents and patent applications in this patent portfolio have been the subject of numerous contentious proceedings in the U.S., Europe, and other jurisdictions, including interference proceedings in the USPTO between the CVC Group and (separately) Broad, Sigma-Aldrich and ToolGen. On February 28, 2021, the USPTO issued a decision in Interference No. 106, 115, concluding that Broad invented certain applications of CRISPR/Cas9 technology in eukaryotic cells before the CVC Group. The CVC Group has appealed the decision to the U.S. Court of Appeals for the Federal Circuit. If the decision is upheld on appeal (including a potential subsequent appeal to the Supreme Court), Broad would maintain its granted patents directed to those applications CRISPR/Cas9 technology in eukaryotic cells, and the CVC Group’s pending patent applications directed to that subject matter would not proceed to grant. We can give no assurances to the ultimate outcome of these proceedings or the disputes between the CVC Group and Broad, Sigma-Aldrich and ToolGen. In December 2023, we entered into an agreement with Editas, providing us a non-exclusive sublicense to certain patents relating to CRISPR/Cas9 technology owned by Broad and Harvard, which are licensed to Editas. In addition to Broad, other third parties have filed patent applications claiming CRISPR/Cas9-related inventions and may allege that they invented one or more of the inventions claimed by the CVC Group. Thus, the USPTO may, in the future, 55 55 55 declare an interference between certain CVC Group patent applications and one or more patent applications. Third parties could seek to assert their patents, if issued, against us based on our CRISPR/Cas9-based activities, including commercialization. Defense of these claims, regardless of their merit, could involve substantial litigation expense and could result in a substantial diversion of management and other employee resources from our business. In the event of a successful claim of infringement against us, we may have to pay substantial damages, obtain one or more licenses from third parties, pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure. In that event, we could be unable to further develop and commercialize CASGEVY or other products that we may develop using the CRISPR/Cas9 technology we license from CRISPR. To the extent that valid present or future third-party patents or other intellectual property rights cover our products, product candidates or technologies, we or our strategic collaborators may seek licenses or other agreements from the holders of such rights to avoid or settle legal claims. Such licenses may not be available on acceptable terms, which may hinder our ability to, or prevent us from being able to, manufacture and market our products. Payments under any licenses that we are able to obtain would reduce our profits derived from the covered products."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We may be subject to claims by third parties asserting that our employees or we have misappropriated their intellectual property, or claiming ownership of what we regard as our own intellectual property.",
      "prior_body": "Many of our employees were previously employed at universities or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that these employees or we have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims. In addition, while it is our policy to require our employees and contractors who may be involved in the development of intellectual property to execute agreements assigning such intellectual property to us, we may be unsuccessful in executing such an agreement with each party who in fact develops intellectual property that we regard as our own. Our and their assignment agreements may not be self-executing or may be breached, and we may be forced to bring claims against third parties, or defend claims they may bring against us, to determine the ownership of what we regard as our intellectual property. If we fail in prosecuting or defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in prosecuting or defending against such claims, litigation could result in substantial costs and be a distraction to management."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "A variety of risks associated with operating in foreign countries could materially adversely affect our business.",
      "prior_body": "We have expanded our international operations over the past several years to market our medicines and expand our research and development capabilities. New laws and industry codes in the E.U. and elsewhere have expanded transparency requirements regarding payments and transfers of value to healthcare professionals, requirements surrounding patient-level clinical trial data, the protection of personal data and increased sanctions for violations. Collectively, our expansion and these new requirements are adding to our compliance costs and potentially exposes us to sanctions in the event of an infringement or failure to report in these jurisdictions. In addition, a significant portion of our commercial supply chain, including sourcing of raw materials and manufacturing, is located in China and the E.U. Consequently, we are, and will continue to be, subject to risks related to operating in foreign countries, including risks relating to intellectual property protections and business interruptions. Risks associated with operating a global biotechnology company include: •differing regulatory requirements for drug approvals and regulation of approved drugs in foreign countries; •varying reimbursement regimes and difficulties or the inability to obtain reimbursement for our products in foreign countries in a timely manner; •differing patient treatment infrastructures, particularly since our business is focused on the treatment of serious diseases that affect relatively smaller numbers of patients and are typically prescribed by specialist physicians; •collectability of accounts receivable; •changes in tariffs, trade barriers, and regulatory requirements, the risks of which appear to have increased in the current political environment; •economic weakness, including recession and inflation, or political instability in particular foreign economies and markets; •differing levels of enforcement and/or recognition of contractual and intellectual property rights; •circulation of unauthorized copy versions of our medicines that infringe our intellectual property rights; •governments seeking to override our intellectual property rights through the introduction of compulsory license or similar mechanisms; •complying with local laws and regulations, which can change significantly over time; •foreign taxes, including withholding of payroll taxes; •foreign currency fluctuations, which could result in reduced revenues or increased operating expenses, and other obligations incident to doing business or operating in another country; •workforce uncertainty in countries where labor unrest is more common than in the U.S.; •reliance on third-party vendors, distributors and suppliers; •import and export licensing requirements, tariffs, and other trade and travel restrictions; •global or regional public health emergencies that could affect our operations or business; •production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad; and •business interruptions resulting from geo-political actions, including war and terrorism. These risks are increased with respect to countries such as China that have substantially different local laws and business practices and weaker protections for intellectual property. In particular, there is currently significant uncertainty about the future relationship between the U.S. and various other countries, including China, with respect to trade policies, treaties, tariffs, taxes, and other limitations on cross-border operations. The U.S. government has made and continues to make significant additional changes in U.S. trade policy and may continue to take future actions that could negatively impact U.S. 57 57 57 trade. For example, legislation has been introduced in Congress to limit certain U.S. biotechnology companies from using equipment or services produced or provided by select Chinese biotechnology companies, and others in Congress have advocated for the use of existing executive branch authorities to limit those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions or what actions may be taken by the other countries in retaliation. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business could be materially and adversely affected. Our revenues are subject to foreign exchange rate fluctuations due to the global nature of our operations. Although we have a foreign currency risk management program, our efforts to reduce currency exchange volatility may not be successful. As a result, currency fluctuations among our reporting currency, the U.S. dollar, and the currencies in which we do business will affect our operating results, often in unpredictable ways. In addition, our international operations are subject to regulation under U.S. law. For example, the FCPA prohibits U.S. companies and their representatives from offering, promising, authorizing or making payments to foreign officials for the purpose of obtaining or retaining business abroad. In many countries, the health care professionals we regularly interact with may meet the definition of a foreign government official for purposes of the FCPA. We also are subject to import/export control laws. Failure to comply with domestic or foreign laws could result in various adverse consequences, including the possible delay in approval or refusal to approve a product, recalls, seizures, withdrawal of an approved product from the market, the imposition of civil or criminal sanctions, the prosecution of executives overseeing our international operations and corresponding bad publicity and negative perception of our company in foreign countries."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We rely on third parties to carry out our operations. Failure to maintain our third-party relationships or challenges at or with these third parties could materially harm our business.",
      "prior_body": "Our business depends on relationships with third parties for a variety of functions, including activities critical to supply and manufacturing, commercialization, research and development, and technology. Failure by these parties to meet their contractual, regulatory, or other obligations, or any disruption in the relationship between Vertex and these third parties, could have an adverse effect on our business. Furthermore, these third parties are subject to their own unique operational and financial risks that are out of our control. When one of our third parties encounters financial, operational, or other difficulties, our business and results of operations could be negatively affected. 59 59 59"
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Our stock price may fluctuate.",
      "prior_body": "Market prices for securities of companies such as ours are highly volatile. From January 1, 2024 to December 31, 2024, our common stock traded between $377.85 and $519.88 per share. The market for our stock, like that of other companies in the biotechnology industry, has experienced significant price and volume fluctuations. The future market price of our securities could be significantly and adversely affected by factors such as: •the information contained in our quarterly earnings releases, including updates regarding our commercialized products or our product candidates, our net product revenues and operating expenses for completed periods and financial guidance regarding future periods; •announcements of FDA actions with respect to our therapies or those of our competitors, or regulatory filings for our therapies or those of our competitors, or announcements of interim or final results of clinical trials or nonclinical studies relating to our therapies or those of our competitors; •announcements we make or commentary by public equity analysts with respect to clinical development of the product candidates in our pain program; •developments in domestic and international governmental policy or regulation, for example, relating to drug pricing and tax law changes; •technological innovations or the introduction of new drugs by our competitors; •government regulatory action; •public concern as to the safety of drugs developed by us or our competitors; •developments in patent or other intellectual property rights or announcements relating to these matters; •information disclosed by third parties regarding our business or products; •developments relating specifically to other companies and market conditions for pharmaceutical and biotechnology stocks or stocks in general; •business development, capital structuring or financing activities; and •general worldwide or national economic, political and capital market conditions, including as a result of inflation and rapid fluctuations in interest rates. Following periods of volatility in the market price of a company’s securities, stockholder derivative lawsuits and securities class action litigation are common. Such litigation, if instituted against us or our officers and directors, could result in substantial costs and a diversion of management’s attention and resources."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Our quarterly operating results are subject to significant fluctuation.",
      "prior_body": "Our operating results have fluctuated from quarter to quarter in the past, and we expect that they will continue to do so in the future. Our revenues are primarily dependent on the amount of net product revenues from sales of our CF medicines. Our total net product revenues could vary on a quarterly basis based on, among other factors, the timing of orders from our significant customers. Additional factors that have caused quarterly fluctuations to our operating results in recent years include variable amounts of revenues; expenses resulting from our significant investments in research and development, acquired in-process research and development, and commercialization activities; changes in the fair values of our strategic investments, and contingent consideration liabilities; charges for excess and obsolete inventories; and our provision for income taxes. Our revenues also are subject to foreign exchange rate fluctuations due to the global nature of our operations. Although we have a foreign currency risk management program, our efforts to reduce currency exchange volatility may not be successful. As a result, currency fluctuations among our reporting currency, the U.S. dollar, and the currencies in which we do business may affect our operating results, often in unpredictable ways. Our quarterly results also could be materially affected by significant charges, which may or may not be similar to charges we have experienced in the past. Most of our operating expenses relate to our research and development activities, do not vary directly with the amount of revenues and are difficult to adjust in the short term. As a result, if revenues in a particular quarter are below expectations, we are unlikely to reduce operating expenses proportionately for that quarter. These examples are only illustrative and other risks, including those discussed in these “Risk Factors,” could also cause fluctuations in our reported financial results. Our operating results during any one period do not necessarily suggest the results of future periods."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "We expect that results from our clinical development activities and the clinical development activities of our competitors will continue to be released periodically, and may result in significant volatility in the price of our common stock.",
      "prior_body": "Any new information regarding our products and product candidates, or competitive products or potentially competitive product candidates, can substantially affect investors’ perceptions regarding our future prospects. We, our collaborators, and our competitors periodically provide updates regarding drug and therapy development programs, typically through press releases, conference calls and presentations at medical conferences. These periodic updates often include interim or final results from clinical trials conducted by us or our competitors and/or information about our or our competitors’ expectations regarding regulatory filings and submissions as well as future clinical development of our products or product candidates, competitive products or potentially competitive product candidates. The timing of the release of information by us regarding our drug and therapy development programs is often beyond our control and is influenced by the timing of receipt of data from our clinical trials and by the general preference among pharmaceutical companies to disclose clinical data during medical conferences. In addition, the information disclosed about our clinical trials, or our competitors’ clinical trials, may be based on interim rather than final data that may involve interpretation difficulties and may in any event not accurately predict final results. The release of such information may result in volatility in the price of our common stock."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "Issuances of additional shares of our common stock could cause the price of our common stock to decline.",
      "prior_body": "As of December 31, 2024, we had 256.9 million shares of common stock issued and outstanding. As of December 31, 2024, we also had 2.7 million unvested restricted stock units (“RSUs”), 0.9 million unvested performance stock units (“PSUs”) at target, and outstanding options to purchase 1.6 million shares of common stock with a weighted-average exercise price of $156.36 per share. The majority of our unvested RSUs are likely to vest based on our employees’ continued employment. The number of PSUs that vest is dependent on a potential range of shares issuable pursuant to certain financial and non-financial milestones, and our employees’ continued employment. Outstanding vested options are likely to be exercised if the market price of our common stock exceeds the applicable exercise price. In addition, we may issue additional common stock or restricted securities in the future as part of financing activities or business development activities and any such issuances may have a dilutive effect on our then-existing shareholders. Sales of substantial amounts of our common stock in the open market, or the availability of such shares for sale, could adversely affect the price of our common stock. The issuance of restricted common stock or common stock upon exercise of any outstanding options would be dilutive, and may cause the market price for a share of our common stock to decline."
    },
    {
      "status": "REMOVED",
      "current_title": null,
      "prior_title": "There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable prices.",
      "prior_body": "In February 2023, our Board of Directors approved a share repurchase program pursuant to which we are authorized to repurchase up to $3.0 billion of our common stock from time to time through open market or privately negotiated transactions, of which $1.6 billion has been repurchased as of December 31, 2024. Our stock repurchases will depend upon, among other factors, market conditions, our cash balances and potential future capital requirements, results of operations, financial condition, and other factors that we may deem relevant. We can provide no assurance that we will repurchase stock at favorable prices, if at all."
    },
    {
      "status": "MODIFIED",
      "current_title": "combinations involving us.",
      "prior_title": "SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS",
      "similarity_score": 0.77,
      "confidence": "high",
      "key_changes": [
        "Reworded sentence: \"Provisions of our articles of organization, by-laws and Massachusetts state laws may frustrate any attempt to remove or replace members of our current Board of Directors and may discourage certain types of business combinations involving us.\"",
        "Reworded sentence: \"Such statements may relate to:•our expectations regarding the amount of, timing of, and trends with respect to our financial performance, including revenues, costs and expenses, and other gains and losses;•our expectations regarding clinical trials, including expectations for patient enrollment, development timelines, the expected timing of data from our ongoing and planned clinical trials, and regulatory authority filings and other submissions for our therapies;•our beliefs, expectations, and plans with respect to the commercial launches of CASGEVY for the treatment of SCD and TDT, ALYFTREK for the treatment of CF, and JOURNAVX for the treatment of moderate-to-severe acute pain, and the anticipated launch of povetacicept for the treatment of IgAN;•our ability to maintain and obtain adequate reimbursement for our products and product candidates, our ability to launch, commercialize and market our products or any of our other therapies for which we obtain regulatory approval, and our ability to obtain label expansions for existing therapies;•our expectations regarding our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to receive our medicines and providing improved treatment options for people who are already eligible for one of our medicines, and our beliefs that the majority of people with CF will transition to ALYFTREK over time;•our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our therapies for further investigation, clinical trials or potential use as a treatment, including with respect to povetacicept as a pipeline-in-a-product and as a potential best-in-class approach for the treatment of IgAN, pMN, and gMG;•the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development, support regulatory filings, or accelerate regulatory approval, including our plans to complete the full submission for potential accelerated approval of povetacicept in IgAN in the first half of 2026 and to share data from the interim analysis of the Phase 2/3 clinical trial of inaxaplin in AMKD in late 2026 or early 2027 and from the Phase 2 trial in people with AMKD in mid-2026;•our beliefs that ALYFTREK will provide additional clinical benefits to eligible people with CF, regarding the durable efficacy and effectiveness of CASGEVY as one-time functional cure for people with SCD and TDT, and regarding the clinical benefits of JOURNAVX without the evidence of the several limitations of other available therapies; •our plans to continue investing in our research and development programs, including anticipated timelines for our programs, and our strategy to develop our pipeline programs, alone or with third-party collaborators;•our beliefs regarding the approximate patient populations for the disease areas on which we focus;•the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, its potential to become a pipeline-in-a-product, and our expectations regarding our agreements with Zai, Ono and WuXi;•our expectations regarding the lower royalty burden for ALYFTREK;•our plans to expand, strengthen, and invest in our global supply chains and manufacturing infrastructure and capabilities, including for biologic and cell and gene therapies; •the effects of import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions;•potential business development activities, including the identification of potential collaborative partners or acquisition targets; 38 38 38 restrictions on voting by any shareholder who acquires 20% or more of the aggregate shareholder voting power without approval by non-interested shareholders.\""
      ],
      "current_body": "Provisions of our articles of organization, by-laws and Massachusetts state laws may frustrate any attempt to remove or replace members of our current Board of Directors and may discourage certain types of business combinations involving us. Our by-laws allow the Board of Directors to adjourn any meetings of shareholders prior to the time the meeting has been convened. We may issue shares of any class or series of preferred stock in the future without shareholder approval and upon such terms as our Board of Directors may determine. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any class or series of preferred stock that may be issued in the future. Massachusetts state law also prohibits us from engaging in specified business combinations with an interested stockholder, subject to certain exceptions, unless the combination is approved or consummated in a prescribed manner, and places 38restrictions on voting by any shareholder who acquires 20% or more of the aggregate shareholder voting power without approval by non-interested shareholders. As a result, shareholders or other parties may find it difficult to remove or replace our directors or to effectuate certain types of business combinations involving us.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K, including the descriptions of our Business set forth in Part I, Item 1, our Risk Factors set forth in Part I, Item 1A, and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Part II, Item 7, contains forward-looking statements. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements may relate to:•our expectations regarding the amount of, timing of, and trends with respect to our financial performance, including revenues, costs and expenses, and other gains and losses;•our expectations regarding clinical trials, including expectations for patient enrollment, development timelines, the expected timing of data from our ongoing and planned clinical trials, and regulatory authority filings and other submissions for our therapies;•our beliefs, expectations, and plans with respect to the commercial launches of CASGEVY for the treatment of SCD and TDT, ALYFTREK for the treatment of CF, and JOURNAVX for the treatment of moderate-to-severe acute pain, and the anticipated launch of povetacicept for the treatment of IgAN;•our ability to maintain and obtain adequate reimbursement for our products and product candidates, our ability to launch, commercialize and market our products or any of our other therapies for which we obtain regulatory approval, and our ability to obtain label expansions for existing therapies;•our expectations regarding our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to receive our medicines and providing improved treatment options for people who are already eligible for one of our medicines, and our beliefs that the majority of people with CF will transition to ALYFTREK over time;•our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our therapies for further investigation, clinical trials or potential use as a treatment, including with respect to povetacicept as a pipeline-in-a-product and as a potential best-in-class approach for the treatment of IgAN, pMN, and gMG;•the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development, support regulatory filings, or accelerate regulatory approval, including our plans to complete the full submission for potential accelerated approval of povetacicept in IgAN in the first half of 2026 and to share data from the interim analysis of the Phase 2/3 clinical trial of inaxaplin in AMKD in late 2026 or early 2027 and from the Phase 2 trial in people with AMKD in mid-2026;•our beliefs that ALYFTREK will provide additional clinical benefits to eligible people with CF, regarding the durable efficacy and effectiveness of CASGEVY as one-time functional cure for people with SCD and TDT, and regarding the clinical benefits of JOURNAVX without the evidence of the several limitations of other available therapies; •our plans to continue investing in our research and development programs, including anticipated timelines for our programs, and our strategy to develop our pipeline programs, alone or with third-party collaborators;•our beliefs regarding the approximate patient populations for the disease areas on which we focus;•the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, its potential to become a pipeline-in-a-product, and our expectations regarding our agreements with Zai, Ono and WuXi;•our expectations regarding the lower royalty burden for ALYFTREK;•our plans to expand, strengthen, and invest in our global supply chains and manufacturing infrastructure and capabilities, including for biologic and cell and gene therapies; •the effects of import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions;•potential business development activities, including the identification of potential collaborative partners or acquisition targets; 38 38 38 restrictions on voting by any shareholder who acquires 20% or more of the aggregate shareholder voting power without approval by non-interested shareholders. As a result, shareholders or other parties may find it difficult to remove or replace our directors or to effectuate certain types of business combinations involving us.SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTSThis Annual Report on Form 10-K, including the descriptions of our Business set forth in Part I, Item 1, our Risk Factors set forth in Part I, Item 1A, and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Part II, Item 7, contains forward-looking statements. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements may relate to:•our expectations regarding the amount of, timing of, and trends with respect to our financial performance, including revenues, costs and expenses, and other gains and losses;•our expectations regarding clinical trials, including expectations for patient enrollment, development timelines, the expected timing of data from our ongoing and planned clinical trials, and regulatory authority filings and other submissions for our therapies;•our beliefs, expectations, and plans with respect to the commercial launches of CASGEVY for the treatment of SCD and TDT, ALYFTREK for the treatment of CF, and JOURNAVX for the treatment of moderate-to-severe acute pain, and the anticipated launch of povetacicept for the treatment of IgAN;•our ability to maintain and obtain adequate reimbursement for our products and product candidates, our ability to launch, commercialize and market our products or any of our other therapies for which we obtain regulatory approval, and our ability to obtain label expansions for existing therapies;•our expectations regarding our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to receive our medicines and providing improved treatment options for people who are already eligible for one of our medicines, and our beliefs that the majority of people with CF will transition to ALYFTREK over time;•our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our therapies for further investigation, clinical trials or potential use as a treatment, including with respect to povetacicept as a pipeline-in-a-product and as a potential best-in-class approach for the treatment of IgAN, pMN, and gMG;•the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development, support regulatory filings, or accelerate regulatory approval, including our plans to complete the full submission for potential accelerated approval of povetacicept in IgAN in the first half of 2026 and to share data from the interim analysis of the Phase 2/3 clinical trial of inaxaplin in AMKD in late 2026 or early 2027 and from the Phase 2 trial in people with AMKD in mid-2026;•our beliefs that ALYFTREK will provide additional clinical benefits to eligible people with CF, regarding the durable efficacy and effectiveness of CASGEVY as one-time functional cure for people with SCD and TDT, and regarding the clinical benefits of JOURNAVX without the evidence of the several limitations of other available therapies; •our plans to continue investing in our research and development programs, including anticipated timelines for our programs, and our strategy to develop our pipeline programs, alone or with third-party collaborators;•our beliefs regarding the approximate patient populations for the disease areas on which we focus;•the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, its potential to become a pipeline-in-a-product, and our expectations regarding our agreements with Zai, Ono and WuXi;•our expectations regarding the lower royalty burden for ALYFTREK;•our plans to expand, strengthen, and invest in our global supply chains and manufacturing infrastructure and capabilities, including for biologic and cell and gene therapies; •the effects of import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions;•potential business development activities, including the identification of potential collaborative partners or acquisition targets; restrictions on voting by any shareholder who acquires 20% or more of the aggregate shareholder voting power without approval by non-interested shareholders. As a result, shareholders or other parties may find it difficult to remove or replace our directors or to effectuate certain types of business combinations involving us.",
      "prior_body": "This Annual Report on Form 10-K, including the descriptions of our Business set forth in Part I, Item 1, our Risk Factors set forth in Part I, Item 1A, and our Management’s Discussion and Analysis of Financial Condition and Results of Operations set forth in Part II, Item 7, contains forward-looking statements. Forward-looking statements are not purely historical and may be accompanied by words such as “anticipates,” “may,” “forecasts,” “expects,” “intends,” “plans,” “potentially,” “believes,” “seeks,” “estimates,” and other words and terms of similar meaning. Such statements may relate to: •our expectations regarding the amount of, timing of, and trends with respect to our financial performance, including revenues, costs and expenses, and other gains and losses; •our expectations regarding clinical trials, including expectations for patient enrollment, development timelines, the expected timing of data from our ongoing and planned clinical trials, and regulatory authority filings and other submissions for our therapies; •our beliefs, expectations, and plans with respect to the commercial launches of CASGEVY for the treatment of SCD and TDT, ALYFTREK for the treatment of CF, and JOURNAVX for the treatment of moderate-to-severe acute pain; •our ability to maintain and obtain adequate reimbursement for our products and product candidates, our ability to launch, commercialize and market our products or any of our other therapies for which we obtain regulatory approval, and our ability to obtain label expansions for existing therapies; •our expectations regarding our ability to continue to grow our CF business by increasing the number of people with CF eligible and able to receive our medicines and providing improved treatment options for people who are already eligible for one of our medicines; •the data that will be generated by ongoing and planned clinical trials and the ability to use that data to advance compounds, continue development, support regulatory filings, or accelerate regulatory approval, including our plans to share data in 2025 from the ongoing clinical trial of VX-522 in patients with CF and from Part B of the ongoing clinical trial evaluating VX-264 in patients with T1D, and our plans to file for accelerated regulatory approvals based on interim analyses from the AMPLITUDE study in AMKD and the RAINIER study in IgAN; •our beliefs that ALYFTREK will provide additional clinical benefits to eligible people with CF, regarding the durable efficacy and effectiveness of CASGEVY as one-time functional cure for people with SCD and TDT, and regarding the clinical benefits of JOURNAVX without the evidence of the limitations of other available therapies; •our beliefs regarding the support provided by clinical trials and preclinical and nonclinical studies of our therapies for further investigation, clinical trials or potential use as a treatment; •our plans to continue investing in our research and development programs, including anticipated timelines for our programs, and our strategy to develop our pipeline programs, alone or with third party-collaborators; •our beliefs regarding the approximate patient populations for the disease areas on which we focus; •the potential benefits and therapeutic scope of our acquisitions and collaborations, including our acquisition of Alpine and its lead asset, povetacicept, its potential to become a pipeline-in-a-product, and our expectations regarding the Zai collaboration; •our expectations regarding the lower royalty burden for ALYFTREK; •our plans to expand, strengthen, and invest in our global supply chains and manufacturing infrastructure and capabilities, including for biologic and cell and gene therapies; •potential business development activities, including the identification of potential collaborative partners or acquisition targets; •our ability to expand and protect our intellectual property portfolio and otherwise maintain exclusive rights to products; •the establishment, development and maintenance of collaborative relationships, including potential milestone payments or other obligations; •potential fluctuations in foreign currency exchange rates and the effectiveness of our foreign currency management program; •our expectations regarding the amount of cash to generated by operations, our cash balance and expected generation and interest income; 64 64 64 •our expectations regarding our provision for or benefit from income taxes and the utilization of our deferred tax assets; •our ability to use our research programs to identify and develop new product candidates to address serious diseases and significant unmet medical needs; •the effectiveness of our governance, plans and strategy with respect to managing cybersecurity risks and other threats to our information technology systems; •our ability to attract and retain skilled personnel; •our expectations involving governmental cost containment and other regulatory efforts; •our expectations surrounding the competitive landscape facing our products and product candidates; and •our liquidity and our expectations regarding the possibility of raising additional capital. Forward-looking statements are subject to certain risks, uncertainties, or other factors that are difficult to predict and could cause actual events or results to differ materially from those indicated in any such statements. These risks, uncertainties, and other factors include, but are not limited to, those described in our Risk Factors, set forth in Part I, Item 1A, and elsewhere in this report and those described from time to time in our future reports filed with the Securities and Exchange Commission. Any such forward-looking statements are made on the basis of our views and assumptions as of the date of the filing and are not estimates of future performance. Except as required by law, we undertake no obligation to publicly update any forward-looking statements. The reader is cautioned not to place undue reliance on any such statements."
    },
    {
      "status": "MODIFIED",
      "current_title": "taxable income.",
      "prior_title": "Our effective tax rate fluctuates, and changes in tax laws, regulations and treaties, unfavorable resolution to the tax positions we have taken or exposure to additional income tax liabilities could have a material impact on our future taxable income.",
      "similarity_score": 0.749,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"Our effective tax rate may be different than experienced in the past due to numerous factors, including: •changes in the mix of our profitability from country to country; •tax authority examinations/audits of our tax filings; •adjustments to the value of our uncertain tax positions; •changes in accounting for income taxes; and •changes in tax laws or modifications of treaties in various jurisdictions.\"",
        "Reworded sentence: \"For example, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax laws in jurisdictions in which we operate, such as the enactments by both E.U.\""
      ],
      "current_body": "Our effective tax rate is derived from a combination of applicable tax rates in the various places that we operate globally. Our effective tax rate may be different than experienced in the past due to numerous factors, including: •changes in the mix of our profitability from country to country; •tax authority examinations/audits of our tax filings; •adjustments to the value of our uncertain tax positions; •changes in accounting for income taxes; and •changes in tax laws or modifications of treaties in various jurisdictions. Any of these factors could cause us to experience an effective tax rate that is significantly different from previous periods or our current expectations. For example, actions taken with respect to tax-related matters by associations such as the Organisation for Economic Co-operation and Development and the European Commission could influence tax laws in jurisdictions in which we operate, such as the enactments by both E.U. and non-E.U. member countries of a global minimum tax. We are subject to ongoing tax audits in various jurisdictions, and local tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the probable outcomes of these audits to determine the appropriateness of our tax provision, and we have established contingency reserves for material tax exposures. However, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax authorities will be resolved at a financial cost that does not exceed our related reserves and the actual outcomes of these disputes and other tax audits could have a material impact on our results of operations or financial condition.",
      "prior_body": "Our effective tax rate is derived from a combination of applicable tax rates in the various places that we operate globally. Our effective tax rate may be different than experienced in the past due to numerous factors, including changes in the mix of our profitability from country to country, tax authority examinations/audits of our tax filings, adjustments to the value of our uncertain tax positions, changes in accounting for income taxes, and changes in tax laws or modifications of treaties in various jurisdictions. Any of these factors could cause us to experience an effective tax rate that is significantly different from previous periods or our current expectations. Various jurisdictions in which the group operates, including the U.K. and the E.U. member states have agreed to implement the minimum tax component (“Pillar Two”) of the Organization for Economic Co-operation and Development’s (the “OECD’s”), global international tax reform initiative that aims to reform international taxation policies and ensure that multinational companies pay taxes wherever they operate and generate profits. Although aspects of Pillar Two have been 61 61 61 implemented that affect accounting periods withing our group starting on or after December 31, 2023, the full impact of this initiative on our effective tax rate will depend on the timing of implementation within each country in which we operate, the exact nature of each country’s implementation legislation, guidance and regulations thereon, and their application by tax authorities either prospectively or retrospectively. We are continuing to evaluate the potential impact on future periods of the Pillar Two guidance, pending legislative adoption by individual countries, including those in which we do business. We are subject to ongoing tax audits in various jurisdictions, and local tax authorities may disagree with certain positions we have taken and assess additional taxes. We regularly assess the probable outcomes of these audits to determine the appropriateness of our tax provision, and we have established contingency reserves for material tax exposures. However, there can be no assurance that we will accurately predict the outcomes of these disputes or other tax audits or that issues raised by tax authorities will be resolved at a financial cost that does not exceed our related reserves and the actual outcomes of these disputes and other tax audits could have a material impact on our results of operations or financial condition."
    },
    {
      "status": "MODIFIED",
      "current_title": "occurring at our facilities.",
      "prior_title": "If our facilities were to experience a catastrophic loss, our operations would be seriously harmed.",
      "similarity_score": 0.707,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"If any of our major facilities were to experience a catastrophic loss due to an earthquake, flood, severe storms, fire or similar event, our operations would be seriously harmed.\"",
        "Reworded sentence: \"If we are unable to effectively implement our business continuity plans, we may experience delays in recovery of data and/or an inability to perform vital corporate functions, which could result in a significant disruption in our operations, large expenses to repair or replace the facility and/or the loss of critical data.\""
      ],
      "current_body": "Most of our operations, including our research and development activities, are conducted in a limited number of facilities. If any of our major facilities were to experience a catastrophic loss due to an earthquake, flood, severe storms, fire or similar event, our operations would be seriously harmed. For example, our corporate headquarters, as well as additional leased space that we use for certain logistical and laboratory operations and manufacturing, are located in a flood zone along the Massachusetts coast. If we are unable to effectively implement our business continuity plans, we may experience delays in recovery of data and/or an inability to perform vital corporate functions, which could result in a significant disruption in our operations, large expenses to repair or replace the facility and/or the loss of critical data. Additionally, we use hazardous materials in some of our facilities, and any accident, injury or other loss related thereto could result in substantial liability. Our property or other relevant insurance may not be sufficient to cover all potential losses that may result from an interruption to our operations or damage resulting from these risks.",
      "prior_body": "Most of our operations, including our research and development activities, are conducted in a limited number of facilities. If any of our major facilities were to experience a catastrophic loss, due to an earthquake, flood, severe storms, fire or similar event, our operations could be seriously harmed. For example, our corporate headquarters, as well as additional leased space that we use for certain logistical and laboratory operations and manufacturing, are located in a flood zone along the Massachusetts coast. We have adopted business continuity plans to address most crises. However, if we are unable to fully implement our business continuity plans, we may experience delays in recovery of data and/or an inability to perform vital corporate functions, which could result in a significant disruption in our research, development, manufacturing and/or commercial activities, large expenses to repair or replace the facility and/or the loss of critical data, which could have a material adverse effect on our business. In addition, we maintain property insurance, however, this insurance may not be sufficient to cover all potential losses that may result from an interruption to our operations."
    },
    {
      "status": "MODIFIED",
      "current_title": "If we fail to scale our operations to accommodate growth, our business may suffer.",
      "prior_title": "If we fail to scale our operations to accommodate growth, our business may suffer.",
      "similarity_score": 0.706,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"As we continue to expand our global operations and capabilities, we face increasing demands on our management and infrastructure.\""
      ],
      "current_body": "As we continue to expand our global operations and capabilities, we face increasing demands on our management and infrastructure. To effectively manage our growing business, we need to: •implement and clearly communicate corporate-wide strategies and effectively prioritize resources; •enhance our operational and financial infrastructure, including data and information controls; •effectively leverage technology and automation where appropriate to enable efficient growth and remain competitive; •improve our administrative, financial and management processes, including decision-making processes and budget prioritization; •effectively grow, train and manage our global employee base; and •expand our compliance and legal resources.",
      "prior_body": "We have expanded and are continuing to expand our global operations and capabilities, which has placed, and will continue to place, significant demands on our management and our operational, research and development and financial infrastructure. To effectively manage our business, we need to continue to adapt as our business grows in scale and complexity across multiple disease states, modalities, and geographies, including by: •implement and clearly communicating our corporate-wide strategies; •enhancing our operational and financial infrastructure, including expansion of our controls over data, records and information; •enhancing our operational, administrative, financial and management processes, including our cross-functional decision-making processes and our budget prioritization systems; •effectively growing, training and managing our global employee base; and •expanding our compliance and legal resources. 56 56 56"
    },
    {
      "status": "MODIFIED",
      "current_title": "impose restrictions on our business.",
      "prior_title": "Future indebtedness could materially and adversely affect our financial condition, and the terms of our credit agreements impose restrictions on our business, reducing our operational flexibility and creating default risks.",
      "similarity_score": 0.654,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"If we borrow under our current credit agreement or any future credit agreements, or otherwise issue or incur additional debt, such indebtedness could have important consequences to our business.\"",
        "Reworded sentence: \"Failure to comply with the covenants could result in an event of default that could trigger acceleration of our indebtedness.\""
      ],
      "current_body": "If we borrow under our current credit agreement or any future credit agreements, or otherwise issue or incur additional debt, such indebtedness could have important consequences to our business. The credit agreement requires that we comply with certain financial covenants, including a consolidated leverage ratio covenant and negative covenants, restricting or limiting our ability and the ability of our subsidiaries to, among other things, incur additional indebtedness, grant liens, engage in certain investment, acquisition and disposition transactions, and enter into transactions with affiliates. As a result, we may be restricted from engaging in business activities that may otherwise improve our business. Failure to comply with the covenants could result in an event of default that could trigger acceleration of our indebtedness. If we incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase.",
      "prior_body": "In July 2022, we entered into a credit agreement providing for a $500.0 million revolving credit facility. If we borrow under our current credit agreement or any future credit agreements, such indebtedness could have important consequences to our business, including increasing our vulnerability to general adverse financial, business, economic and industry conditions, 62 62 62 as well as other factors that are beyond our control. The credit agreement requires that we comply with certain financial covenants, including a consolidated leverage ratio covenant. Further, the credit agreement includes negative covenants, subject to exceptions, restricting or limiting our ability and the ability of our subsidiaries to, among other things, incur additional indebtedness, grant liens, engage in certain investment, acquisition and disposition transactions, and enter into transactions with affiliates. As a result, we may be restricted from engaging in business activities that may otherwise improve our business. Failure to comply with the covenants could result in an event of default that could trigger acceleration of our indebtedness, which would require us to repay all amounts owed under the credit agreements and/or our finance leases and could have a material adverse effect on our business. Additionally, our obligations under the credit agreement are unconditionally guaranteed by certain of our domestic subsidiaries. If we incur additional indebtedness, the risks related to our business and our ability to service or repay our indebtedness would increase."
    },
    {
      "status": "MODIFIED",
      "current_title": "We are subject to various and evolving laws and regulations governing the privacy and security of personal data.",
      "prior_title": "We may face manufacturing, supply, and distribution difficulties, among other challenges, delays, or interruptions, including at our third-party providers.",
      "similarity_score": 0.638,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"We are subject to a variety of evolving and developing data privacy and security laws and regulations in various jurisdictions related to the collection, storage, use, sharing, and security of personal data, including health information.\"",
        "Added sentence: \"Additionally, even with relevant experience and expertise, drug manufacturers often encounter difficulties in scale-up and production, including difficulties with production costs and yields, quality control, and compliance with federal, state and foreign 32 32 32 Risks Related to Our OperationsWe may face manufacturing, supply, and distribution delays, difficulties, and disruptions, among other challenges, including at our third-party providers.\"",
        "Added sentence: \"We could be subject to significant supply interruptions for our commercial products or product candidates as a result of disruptions to our internal manufacturing capabilities or those of our suppliers or partners.\"",
        "Added sentence: \"Supply disruptions may result from a variety of factors, including shortages in product raw materials or labor, technical difficulties, regulatory inspections or restrictions, delays in construction, regulatory approval, and inspection of new facilities or the expansion of existing facilities, shipping or customs delays, inability to maintain compliance with quality or other regulations, including cGMP requirements, general global supply chain disruptions, and performance failures by us or any third-party manufacturer on which we rely.\"",
        "Added sentence: \"Disruption in our supply chain or manufacturing capabilities can result in shipment delays, inventory shortages, lot failures, product withdrawals, recalls and other interruptions in the commercial and clinical supply of our products and product candidates.\""
      ],
      "current_body": "We are subject to a variety of evolving and developing data privacy and security laws and regulations in various jurisdictions related to the collection, storage, use, sharing, and security of personal data, including health information. Regulators globally are imposing data privacy and security requirements, such as the E.U.’s GDPR and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act. These and other similar types of laws and regulations that have been or may be passed often include requirements with respect to personal information. Compliance with privacy laws and regulations is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices. Failure to comply may result in liability through government enforcement, private actions, civil and criminal fines and penalties, litigation, and reputational harm. Although we are not directly subject to HIPAA, we could face penalties, including criminal liability, for knowingly obtaining or disclosing protected health information from non-compliant HIPAA-covered entities. The commercialization of cell and genetic therapies involves processing more personal data than traditional therapies, increasing our risk exposure. Furthermore, the number of government investigations, enforcement actions, and class action lawsuits related to data security incidents and privacy violations, particularly focused on online data sharing, continue to increase. Government investigations typically require significant resources and generate negative publicity, which could harm our business and reputation. 32Risks Related to Our OperationsWe may face manufacturing, supply, and distribution delays, difficulties, and disruptions, among other challenges, including at our third-party providers. We could be subject to significant supply interruptions for our commercial products or product candidates as a result of disruptions to our internal manufacturing capabilities or those of our suppliers or partners. Supply disruptions may result from a variety of factors, including shortages in product raw materials or labor, technical difficulties, regulatory inspections or restrictions, delays in construction, regulatory approval, and inspection of new facilities or the expansion of existing facilities, shipping or customs delays, inability to maintain compliance with quality or other regulations, including cGMP requirements, general global supply chain disruptions, and performance failures by us or any third-party manufacturer on which we rely. Disruption in our supply chain or manufacturing capabilities can result in shipment delays, inventory shortages, lot failures, product withdrawals, recalls and other interruptions in the commercial and clinical supply of our products and product candidates. Any such disruption with respect to our commercial products could result in a failure to meet market demand, could negatively affect our patients, could reduce our net product revenues and/or increase our costs. Any such disruption in the supply of product candidates to our clinical trials could negatively affect the subjects enrolled in our clinical trials and/or cause delays in our clinical trials and applications for regulatory approval. Additionally, unfavorable geopolitical events could affect our ability to interact with or conduct business with specific vendors within our global supply network or could prevent or delay the transportation of supplies or products to their planned destination. For example, we depend on China-based suppliers for portions of our supply chain. Finding alternative suppliers due to geopolitical developments or otherwise may not be feasible or could take a significant amount of time and involve significant expense due to the nature of our products and the need to obtain regulatory approvals.If we are unable to maintain and expand our supply chain and manufacturing capabilities, our ability to develop our product candidates and manufacture our products would be harmed.We continue to invest in and expand our manufacturing capabilities and supplier relationships to ensure the stability of our supply chains and to support the anticipated demand for our products. Establishing, managing and expanding our global manufacturing capabilities and supply chain, particularly as we enter new therapeutic modalities, requires significant financial commitment. This includes the creation and maintenance of numerous third-party contractual relationships upon which we rely. There can be no assurance that we will be able to identify, establish and maintain additional manufacturers or capacity for our product candidates and products on a timely basis, on commercially reasonable terms, or at all. The foregoing risks may be heightened where our products and the materials that we utilize in our operations are manufactured by only one supplier or at only one facility. In addition, in the course of providing its services, a contract manufacturer may develop process technology related to the manufacture of our products or product candidates that the manufacturer owns, either independently or jointly with us. This would increase our reliance on that manufacturer or require us to obtain a license from that manufacturer to have our products or product candidates manufactured by other suppliers utilizing the same process.In addition, we and our CMOs and corporate partners are subject to cGMP, as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies. Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with applicable regulatory requirements, including cGMP. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations. There can be no assurance that we or our CMOs and corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections.Furthermore, the manufacturing and logistics for drug products are highly complex and can require significant investment, including to scale-up manufacturing processes and to secure capacity at third parties with expertise to meet our requirements. This capacity may be limited by the number of other clinical trials and commercial manufacturing ongoing for other companies seeking similar support. There are many risks that could result in delays and additional costs, including the need to hire and train qualified employees and obtain access to necessary equipment and third-party technology. Additionally, even with relevant experience and expertise, drug manufacturers often encounter difficulties in scale-up and production, including difficulties with production costs and yields, quality control, and compliance with federal, state and foreign 32 32 32 Risks Related to Our OperationsWe may face manufacturing, supply, and distribution delays, difficulties, and disruptions, among other challenges, including at our third-party providers. We could be subject to significant supply interruptions for our commercial products or product candidates as a result of disruptions to our internal manufacturing capabilities or those of our suppliers or partners. Supply disruptions may result from a variety of factors, including shortages in product raw materials or labor, technical difficulties, regulatory inspections or restrictions, delays in construction, regulatory approval, and inspection of new facilities or the expansion of existing facilities, shipping or customs delays, inability to maintain compliance with quality or other regulations, including cGMP requirements, general global supply chain disruptions, and performance failures by us or any third-party manufacturer on which we rely. Disruption in our supply chain or manufacturing capabilities can result in shipment delays, inventory shortages, lot failures, product withdrawals, recalls and other interruptions in the commercial and clinical supply of our products and product candidates. Any such disruption with respect to our commercial products could result in a failure to meet market demand, could negatively affect our patients, could reduce our net product revenues and/or increase our costs. Any such disruption in the supply of product candidates to our clinical trials could negatively affect the subjects enrolled in our clinical trials and/or cause delays in our clinical trials and applications for regulatory approval. Additionally, unfavorable geopolitical events could affect our ability to interact with or conduct business with specific vendors within our global supply network or could prevent or delay the transportation of supplies or products to their planned destination. For example, we depend on China-based suppliers for portions of our supply chain. Finding alternative suppliers due to geopolitical developments or otherwise may not be feasible or could take a significant amount of time and involve significant expense due to the nature of our products and the need to obtain regulatory approvals.If we are unable to maintain and expand our supply chain and manufacturing capabilities, our ability to develop our product candidates and manufacture our products would be harmed.We continue to invest in and expand our manufacturing capabilities and supplier relationships to ensure the stability of our supply chains and to support the anticipated demand for our products. Establishing, managing and expanding our global manufacturing capabilities and supply chain, particularly as we enter new therapeutic modalities, requires significant financial commitment. This includes the creation and maintenance of numerous third-party contractual relationships upon which we rely. There can be no assurance that we will be able to identify, establish and maintain additional manufacturers or capacity for our product candidates and products on a timely basis, on commercially reasonable terms, or at all. The foregoing risks may be heightened where our products and the materials that we utilize in our operations are manufactured by only one supplier or at only one facility. In addition, in the course of providing its services, a contract manufacturer may develop process technology related to the manufacture of our products or product candidates that the manufacturer owns, either independently or jointly with us. This would increase our reliance on that manufacturer or require us to obtain a license from that manufacturer to have our products or product candidates manufactured by other suppliers utilizing the same process.In addition, we and our CMOs and corporate partners are subject to cGMP, as well as comparable regulations in other jurisdictions. Manufacturing operations are also subject to routine inspections by regulatory agencies. Even after a supplier is qualified by the regulatory authority, the supplier must continue to expend time, money and effort in the area of production and quality control to maintain full compliance with applicable regulatory requirements, including cGMP. If, as a result of these inspections, a regulatory authority determines that the equipment, facilities, laboratories or processes do not comply with applicable regulations and conditions of product approval, the regulatory authority may suspend the manufacturing operations. There can be no assurance that we or our CMOs and corporate partners will be able to remedy any deficiencies cited by FDA or other regulatory agencies in their inspections.Furthermore, the manufacturing and logistics for drug products are highly complex and can require significant investment, including to scale-up manufacturing processes and to secure capacity at third parties with expertise to meet our requirements. This capacity may be limited by the number of other clinical trials and commercial manufacturing ongoing for other companies seeking similar support. There are many risks that could result in delays and additional costs, including the need to hire and train qualified employees and obtain access to necessary equipment and third-party technology. Additionally, even with relevant experience and expertise, drug manufacturers often encounter difficulties in scale-up and production, including difficulties with production costs and yields, quality control, and compliance with federal, state and foreign",
      "prior_body": "We rely on a worldwide network of third-party manufacturers and our internal capabilities, including our own manufacturing facilities in Boston, to manufacture product candidates for clinical trials as well as our medicines for commercial use. We also depend on third-party logistics providers to manage our shipments globally, and on approved distributors for supply, sales and marketing in certain markets. While we have developed internal capabilities to supply product candidates for use in our clinical trials as well as some of our products for commercial sale, a majority of the manufacturing steps needed to produce our medicines, therapies, product candidates, and drug products are performed through a third-party manufacturing network. The manufacture of our products and product candidates can be complex, which may require lengthy technology transfers between us and the third parties on which we rely. We expect that we will continue to rely on third parties to meet our commercial supply needs and a significant portion of our clinical supply needs for the foreseeable future. We could be subject to significant supply interruptions as a result of disruptions to third party or our internal manufacturing capabilities. Our supply chain for sourcing raw materials and manufacturing drug product ready for distribution, including obtaining necessary supplies, is a multi-step international endeavor. Third-party contract manufacturers, including some in China, perform different parts of our manufacturing process. Contract manufacturers may supply us with raw materials, convert these raw materials into drug substance and/or convert the drug substance into final dosage form. We also use third parties are used for packaging, warehousing, and distribution of products. We maintain property insurance to cover potential losses that may result from supply interruptions or destruction at these third parties, however, this insurance may not be sufficient to cover all potential losses that may result. The manufacturing and logistics for cell and genetic therapies are highly complex, often short lead time operations that require partnership with an extensive network of third parties to deliver product. These manufacturing and logistics operations require significant investment by us to secure capacity at third parties with expertise to meet our requirements. Even with the relevant experience and expertise, manufacturers of cell and genetic therapy products often encounter difficulties in production, including difficulties with production costs and yields, quality control, and compliance with federal, state and foreign regulations. There are many risks that could result in delays and additional costs, including the need to hire and train qualified employees and obtain access to necessary equipment and third-party technology. This capacity may be limited by the number of other clinical trials and commercial manufacturing ongoing for other companies seeking similar support. If third parties are unwilling or unable to meet our requirements, we could experience supply disruptions outside of our control. Additionally, manufacturing facilities, both foreign and domestic, are subject to inspections by the FDA and other U.S. and foreign government authorities. Although we actively engage with regulatory authorities, the timing of regulatory approvals for each of these facilities may be delayed for a variety of reasons. We may experience supply disruptions if regulatory agencies are unable to inspect the manufacturing facilities on which we rely. In addition, we and the third parties with whom we engage are required to maintain compliance with quality regulations globally. An inability to maintain compliance with such regulations, including cGMP requirements, could cause significant disruptions to our business and operations. Additionally, establishing, managing and expanding our global manufacturing and supply chain requires a significant financial commitment and the creation and maintenance of our numerous third-party contractual relationships. We may not 50 50 50 be able to agree on contractual terms with third parties as needed for manufacturing of our products. Although we attempt to manage the business relationships with our partners, we could be subject to supply disruptions outside of our control. Supply disruptions may result from a number of factors, including shortages in product raw materials, labor or technical difficulties, regulatory inspections or restrictions, shipping or customs delays, general global supply chain disruptions, events beyond our control, or any other performance failure by us or any third-party manufacturer on which we rely. Additionally, unfavorable geopolitical events or situations could affect our ability to interact with or conduct business with specific vendors within our global supply network, or could prevent or delay the transportation of supplies or products to their planned destination. Any such disruptions could disrupt sales of our products and/or the timing or advancement of our clinical trials. If we or our third-party manufacturers become unable (including potentially through governmental actions or legislation targeted toward them) or unwilling to continue manufacturing product and we are not able to promptly identify another manufacturer, we could experience a disruption in the commercial supply of our then-marketed medicines, which would have a significant effect on patients, our business, and our product revenues. Similarly, a disruption in the clinical supply of product candidates could delay the completion of clinical trials and affect timelines for regulatory filings. We have a limited number of critical steps and key materials for our manufacturing process that are single sourced, including for commercialized products. To ensure the stability of our supply chains, we continue to develop alternative suppliers for our manufacturing processes and key materials. However, there can be no assurance that we will be able to establish and maintain additional manufacturers or capacity for all of our product candidates and products on a timely basis or at all. In the course of providing its services, a contract manufacturer may develop process technology related to the manufacture of our products or product candidates that the manufacturer owns, either independently or jointly with us. This would increase our reliance on that manufacturer or require us to obtain a license from that manufacturer to have our products or product candidates manufactured by other suppliers utilizing the same process."
    },
    {
      "status": "MODIFIED",
      "current_title": "If we fail to attract and retain skilled employees, our business could be materially harmed.",
      "prior_title": "If we fail to attract and retain skilled employees, our business could be materially harmed.",
      "similarity_score": 0.629,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"We must attract and retain highly qualified and trained scientists, as well as employees with experience in the development, manufacture, and commercialization of medicines, including biologic and cell and genetic therapies.\""
      ],
      "current_body": "We must attract and retain highly qualified and trained scientists, as well as employees with experience in the development, manufacture, and commercialization of medicines, including biologic and cell and genetic therapies. We face intense competition for such talent from our competitors, other companies, academic institutions, and other organizations throughout our industry, especially with respect to employees with expertise in cell or genetic therapies. Our compensation program, including equity awards, may not be sufficient to retain employees, especially if our stock price declines or other employers offer more attractive opportunities. Our ability to commercialize our products and achieve our research and development objectives depends on our ability to respond effectively to these demands. If we are unable to hire and retain qualified personnel, our ability to advance our pipeline, commercialize our products, and achieve our business objectives could be materially adversely affected.",
      "prior_body": "Due to the highly technical nature of our drug discovery and development activities, we require the services of highly qualified and trained scientists who have the skills necessary to conduct these activities. In addition, we need to attract and retain employees with experience in development, marketing and commercialization of medicines and therapies, including cell and genetic therapies. We provide stock-related compensation benefits to all of our key employees that vest over time and therefore induce them to remain with us and have entered into employment agreements with some executives. However, the employment agreements can be terminated by the executive on relatively short notice. The value to employees of stock-related benefits that vest over time can be significantly affected by movements in our stock price and business performance, and may, at any point in time, be insufficient to counteract more lucrative offers from other companies. We face intense competition for our personnel from our competitors and other companies throughout our industry, especially with respect to employees with expertise in cell or genetic therapies. We also experience competition for the hiring of scientific and clinical personnel from universities and research institutions. Moreover, the growth of local biotechnology companies and the expansion of major pharmaceutical companies into the Boston area has increased competition for the available pool of skilled employees, especially in technical fields. The high cost of living can make it difficult to attract employees to our global headquarters in Boston and our international headquarters in London. Challenges could adversely affect our operations and financial results if we do not have sufficient staff to perform necessary functions. In addition, the available pool of skilled employees would be further reduced if immigration laws change in a manner that increases restrictions on immigration. Our ability to continue to commercialize our products and achieve our research and development objectives depends on our ability to respond effectively to these demands. If we are unable to hire and retain qualified personnel, there could be a material adverse effect on our business."
    },
    {
      "status": "MODIFIED",
      "current_title": "The use of social media platforms presents risks and challenges.",
      "prior_title": "The use of social media platforms and artificial intelligence tools presents risks and challenges.",
      "similarity_score": 0.617,
      "confidence": "medium",
      "key_changes": [
        "Reworded sentence: \"Social media is increasingly used by patients, advocacy groups, and other third parties to discuss our products and product candidates.\""
      ],
      "current_body": "Social media is increasingly used by patients, advocacy groups, and other third parties to discuss our products and product candidates. Social media posts may include statements about efficacy or adverse events that could create reporting obligations or regulatory scrutiny. Our employees’ use of social media also presents risks, including potential noncompliance with legal or regulatory requirements, inappropriate disclosure of confidential information or personal information, and loss of intellectual property. In addition, misinformation, negative sentiment, or impersonation of our business on social media could cause reputational damage or otherwise harm our business. Failure to appropriately manage these risks could result in regulatory actions, liability, or other adverse consequences.",
      "prior_body": "Social media is being used by third parties to communicate about our products and product candidates and the diseases our therapies are designed to treat. We believe that members of the communities supporting serious diseases may be more active on social media as compared to other patient populations due to the demographics of those patient populations. Social media practices in the pharmaceutical and biotechnology industries are evolving, which creates uncertainty and risk of noncompliance with regulations applicable to our business. For example, patients may use social media platforms to comment on the effectiveness of, or adverse experiences with, a product or a product candidate, which could result in reporting obligations. In addition, our employees may engage on social media in ways that may not comply with legal or regulatory requirements, which may give rise to liability, lead to the loss of trade secrets and other intellectual property, or result in public disclosure of protected personal information. There is a risk of inappropriate disclosure of sensitive information or negative or inaccurate posts or comments about us on any social networking website. Negative sentiment about us or our business shared over social media, or misinformation disseminated from fraudulent accounts impersonating our employees or our business, or otherwise, could harm our business and reputation, whether or not it is based in fact. Certain data protection regulations, such as the GDPR, apply to personal data contained on social media. If any of these events were to occur or we otherwise fail to comply with applicable regulations, we could incur liability, face regulatory actions or incur harm to our business, including damage to our reputation. Similar risks relating to inappropriate disclosure of sensitive information or inaccurate information appearing in the public domain may also apply from our employees engaging with and use of new artificial intelligence tools, such as ChatGPT. 60 60 60"
    },
    {
      "status": "MODIFIED",
      "current_title": "Our success depends on our ability to develop and commercialize additional medicines.",
      "prior_title": "If we are unable to successfully develop and commercialize additional products, our business could be materially harmed.",
      "similarity_score": 0.594,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"We invest significant resources in research and development to discover and develop transformative medicines for people with serious diseases.\"",
        "Reworded sentence: \"Product candidates may appear promising in research and development but may fail to reach commercial success for many reasons, including: •the failure to establish safety and efficacy through clinical trials; •the failure to obtain marketing approval; •the inability to manufacture on economically feasible terms; •the failure to gain and maintain market acceptance among physicians and patients or other members of the medical community; •the failure to obtain adequate pricing or reimbursement levels from third-party payors or foreign governments; and •competition based on, among other factors, safety, efficacy, patient convenience, pricing and reimbursement.\""
      ],
      "current_body": "We invest significant resources in research and development to discover and develop transformative medicines for people with serious diseases. Product development is highly uncertain and expensive. Product candidates may appear promising in research and development but may fail to reach commercial success for many reasons, including: •the failure to establish safety and efficacy through clinical trials; •the failure to obtain marketing approval; •the inability to manufacture on economically feasible terms; •the failure to gain and maintain market acceptance among physicians and patients or other members of the medical community; •the failure to obtain adequate pricing or reimbursement levels from third-party payors or foreign governments; and •competition based on, among other factors, safety, efficacy, patient convenience, pricing and reimbursement. If we are not able to successfully develop and commercialize additional medicines, our business would be materially harmed.",
      "prior_body": "We invest significant resources in the research and development of therapies for serious diseases and conditions, including CF, SCD, TDT, acute and peripheral neuropathic pain, IgAN, AMKD, T1D, DM1, and ADPKD. Product development is highly uncertain and expensive. Product candidates that may appear promising in research and development may fail to reach commercial success for many reasons, including: •the failure to establish safety and efficacy through clinical trials; •the failure to obtain marketing approval for the product candidate; •the inability to manufacture the product candidate on economically feasible terms; •the failure to gain and maintain market acceptance among physicians and patients or other members of the medical community; and •the failure to obtain market acceptance or adequate reimbursement levels from third-party payors or foreign governments for such product. If we are not able to successfully develop and commercialize additional products our business could be materially harmed."
    },
    {
      "status": "MODIFIED",
      "current_title": "negatively affected, the approved product could lose its approval, and our business could be materially harmed.",
      "prior_title": "If we discover safety issues with any of our products or if we fail to comply with continuing U.S. and applicable foreign regulations, commercialization efforts for the product could be negatively affected, the approved product could lose its approval, and our business could be materially harmed.",
      "similarity_score": 0.587,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"After regulatory approval and launch, our products are used over longer periods of time and by larger populations of patients than during pre-approval clinical trials.\"",
        "Reworded sentence: \"If any of our CF products were to experience safety issues or labeling modifications, our other CF products may be adversely affected.\""
      ],
      "current_body": "After regulatory approval and launch, our products are used over longer periods of time and by larger populations of patients than during pre-approval clinical trials. Additional clinical and non-clinical studies, such as for label expansions, new combinations or otherwise, may also be conducted after regulatory approval. For example, as part of FDA approval for CASGEVY, we are required to conduct post-marketing safety studies to assess certain long-term risks associated with the treatment. Additionally, when post-marketing studies involve our marketed products, or an active pharmaceutical ingredient thereof, they can raise new safety issues for our existing products. The subsequent discovery or appearance of previously unknown or underestimated safety or efficacy concerns with a product could negatively affect commercial sales of the product, result in reduced coverage or reimbursement by payors, cause reputational harm, government investigations, and/or lawsuits against us. Subsequent adverse safety events, as well as safety or efficacy issues affecting suppliers or competing products, may also lead to recalls, denial or withdrawal of regulatory approvals, non-renewal of conditional regulatory approvals, label changes, obligations to conduct additional or more extensive clinical trials or to implement a risk management plan, and reductions in market acceptance. Each of our CF products shares at least one active pharmaceutical ingredient with another of our products. If any of our CF products were to experience safety issues or labeling modifications, our other CF products may be adversely affected. For example, in December 2024, the FDA required us to modify the TRIKAFTA label by revising information regarding liver injury and liver failure and moving that information from the “warnings and precautions” section to a “boxed warning” section; the FDA required similar language in the ALYFTREK label. In addition, safety or efficacy issues affecting suppliers’ or competitors’ products also may reduce the market acceptance of our products. The discovery of safety events involving our products or public speculation about such events could limit or reduce product revenues and cause our stock price to decline or experience periods of volatility.",
      "prior_body": "Our products are subject to continuing regulatory oversight, including the review of additional safety information. Products are more widely used by patients once approval has been obtained and therefore side effects and other problems may be observed after approval that were not seen or anticipated, or were not as prevalent or severe, during pre-approval clinical trials or nonclinical studies. The subsequent discovery or appearance of previously unknown or underestimated problems with a product could negatively affect commercial sales of the product, result in restrictions on the product or lead to the withdrawal of the product from the market. Each of our CF products shares at least one active pharmaceutical ingredient with another of our products. As a result, if any of our CF products were to experience safety issues or labeling modifications, our other CF products may be adversely affected. For example, in December 2024, the FDA modified the labeling of TRIKAFTA by revising information regarding liver injury and liver failure and moving it from the “warnings and precautions” section to a “boxed warning” section, and included similar language in the ALYFTREK label. In SCD and TDT, as part of the FDA approval for CASGEVY, we are required to conduct two post-marketing requirement safety studies to assess the long-term risk of hematologic malignancies and off-target genome editing effects by CRISPR/Cas9. Negative or ambiguous results from these studies could have a significant impact on our ability to commercialize our products. The reporting of adverse safety events involving our products or public speculation about such events could cause our stock price to decline or experience periods of volatility. Our business also may be materially harmed by reduced coverage or reimbursement by payors, impaired sales of our products, denial or withdrawal of regulatory approvals, non-renewal of conditional regulatory approvals, required label changes or additional clinical trials, reputational harm, or government investigations or lawsuits brought against us. Our products are subject to ongoing regulatory requirements governing the testing, manufacturing, labeling, packaging, storage, advertising, promotion, sale, distribution, import, export, recordkeeping, and submission of safety and other post-market information. We and our third-party manufacturers must comply with cGMP and other applicable regulations governing the manufacturing and distribution of our products. Regulatory authorities periodically inspect our drug manufacturing facilities, and those of our third-party manufacturers, to evaluate compliance with cGMP and other regulatory requirements. If we or our collaborators, or third-parties acting on our behalf, fail to comply with applicable continuing regulatory requirements, we or our collaborators may be subject to fines, suspension or withdrawal of regulatory approvals for specific products, product recalls and seizures, operating restrictions and/or criminal prosecutions, any of which could have a material adverse effect on our business, reputation, financial condition, and results of operations. 37 37 37"
    },
    {
      "status": "MODIFIED",
      "current_title": "A variety of risks associated with operating in foreign countries could materially adversely affect our business.",
      "prior_title": "A breakdown or breach of our information technology systems could subject us to liability or interrupt the operation of our business.",
      "similarity_score": 0.584,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"Our global operations subject us to risks that could adversely affect our business and revenue.\""
      ],
      "current_body": "Our global operations subject us to risks that could adversely affect our business and revenue. In addition to the ex-U.S. risks we face with respect to compliance with local laws and regulatory requirements, pricing and reimbursement, intellectual property, manufacturing capabilities and supply chain, foreign exchange risks, and reliance on third parties, risks associated with operating a global biotechnology company include the potential for: •economic weakness, including recession and inflation, or political instability globally or with respect to particular foreign economies and markets; •business interruptions resulting from geo-political actions, including war and terrorism; •import and export licensing requirements, tariffs, trade barriers, and other trade and travel restrictions, the risks of which appear to have increased in the current political environment; •credit risks related to our customers, which may be higher in less developed markets; and •global or regional public health emergencies. 34If any of the above risks were to occur, our revenues, results of operations, financial condition or business could be materially harmed.Current or future U.S. legislation, including executive orders, or other new changes in laws, regulations or policies in the U.S. or other countries could negatively impact our business by increasing costs, decreasing demand for our products, and increasing government cost controls, among other risks. For example, U.S. legislation has been introduced to limit certain U.S. biotechnology companies from using equipment or services from select Chinese biotechnology companies, and others in Congress have advocated for limitations on those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions, the effective date or duration of such actions, or what actions may be taken by the other countries in response to actions by the United States. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business could be materially and adversely affected. A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business. We maintain and rely extensively on information technology systems and network infrastructures, internally and with third parties for the effective operation of our business. We collect, store, and transmit confidential information, including personal information, financial information and intellectual property. Disruption, infiltration, or failure of our information technology systems because of software or hardware malfunctions, computer viruses, cyber-attacks, employee theft or misuse, power disruptions, natural disasters or accidents could cause breaches of data security and/or loss of critical data, which in turn could materially adversely affect our business.Cyber-attacks and incidents are increasing in their frequency, sophistication, and intensity, and are difficult to detect. Cyber-attacks are carried out by well-resourced groups and individuals with a wide range of motives and expertise. Due to the nature of some cyber-attacks and incidents, there is a risk that they may remain undetected for a period of time. Recent developments in the threat landscape include the use of adversarial artificial intelligence techniques and machine learning, as well as an increased number of cyber extortion attacks with higher financial ransom demand amounts and increasing sophistication and variety of ransomware techniques. Cyber-attacks and incidents also include manufacturing, hardware or software supply chain attacks, which could cause disruption to or a delay in the manufacturing of our products or product candidates, or lead to data privacy or security breach. We use cloud technologies and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks or data privacy incidents could disrupt our operations and result in misappropriation, corruption, or loss of confidential or proprietary information. The third parties upon which we rely face similar risks and when they experience a security breach of their systems, our security can be adversely affected.Like many companies, we have experienced immaterial cybersecurity incidents, including temporary service interruptions of third-party suppliers. There can be no assurance that our efforts to protect our data and information systems will prevent breakdowns or breaches in our systems that could adversely affect our business. While we maintain cyber liability insurance, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems and those of critical third parties. Cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws. In addition, we face certain risks as we seek to leverage artificial intelligence to optimize productivity and efficiency in various aspects of the organization. Flaws, biases, or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting our operations, financial condition, and reputation. Ethical and legal challenges may arise, including biases or discrimination in generated outcomes, non-compliance with data protection regulations and laws specifically governing the use of artificial intelligence systems and tools, and lack of transparency. Furthermore, the deployment of artificial intelligence systems could expose us to increased cybersecurity threats, such as data breaches and unauthorized access. We also face competitive risks if we do not implement artificial intelligence or other machine learning technologies in a timely fashion. 34 34 34 If any of the above risks were to occur, our revenues, results of operations, financial condition or business could be materially harmed.Current or future U.S. legislation, including executive orders, or other new changes in laws, regulations or policies in the U.S. or other countries could negatively impact our business by increasing costs, decreasing demand for our products, and increasing government cost controls, among other risks. For example, U.S. legislation has been introduced to limit certain U.S. biotechnology companies from using equipment or services from select Chinese biotechnology companies, and others in Congress have advocated for limitations on those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions, the effective date or duration of such actions, or what actions may be taken by the other countries in response to actions by the United States. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business could be materially and adversely affected. A breakdown or breach of our information technology systems, or unauthorized access to confidential information could adversely affect our business. We maintain and rely extensively on information technology systems and network infrastructures, internally and with third parties for the effective operation of our business. We collect, store, and transmit confidential information, including personal information, financial information and intellectual property. Disruption, infiltration, or failure of our information technology systems because of software or hardware malfunctions, computer viruses, cyber-attacks, employee theft or misuse, power disruptions, natural disasters or accidents could cause breaches of data security and/or loss of critical data, which in turn could materially adversely affect our business.Cyber-attacks and incidents are increasing in their frequency, sophistication, and intensity, and are difficult to detect. Cyber-attacks are carried out by well-resourced groups and individuals with a wide range of motives and expertise. Due to the nature of some cyber-attacks and incidents, there is a risk that they may remain undetected for a period of time. Recent developments in the threat landscape include the use of adversarial artificial intelligence techniques and machine learning, as well as an increased number of cyber extortion attacks with higher financial ransom demand amounts and increasing sophistication and variety of ransomware techniques. Cyber-attacks and incidents also include manufacturing, hardware or software supply chain attacks, which could cause disruption to or a delay in the manufacturing of our products or product candidates, or lead to data privacy or security breach. We use cloud technologies and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks or data privacy incidents could disrupt our operations and result in misappropriation, corruption, or loss of confidential or proprietary information. The third parties upon which we rely face similar risks and when they experience a security breach of their systems, our security can be adversely affected.Like many companies, we have experienced immaterial cybersecurity incidents, including temporary service interruptions of third-party suppliers. There can be no assurance that our efforts to protect our data and information systems will prevent breakdowns or breaches in our systems that could adversely affect our business. While we maintain cyber liability insurance, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems and those of critical third parties. Cybersecurity incidents can cause the loss of critical or sensitive information, including personal information, and could give rise to legal liability and regulatory action under data protection and privacy laws. In addition, we face certain risks as we seek to leverage artificial intelligence to optimize productivity and efficiency in various aspects of the organization. Flaws, biases, or malfunctions in these systems could lead to operational disruptions, data loss, or erroneous decision-making, impacting our operations, financial condition, and reputation. Ethical and legal challenges may arise, including biases or discrimination in generated outcomes, non-compliance with data protection regulations and laws specifically governing the use of artificial intelligence systems and tools, and lack of transparency. Furthermore, the deployment of artificial intelligence systems could expose us to increased cybersecurity threats, such as data breaches and unauthorized access. We also face competitive risks if we do not implement artificial intelligence or other machine learning technologies in a timely fashion. If any of the above risks were to occur, our revenues, results of operations, financial condition or business could be materially harmed. Current or future U.S. legislation, including executive orders, or other new changes in laws, regulations or policies in the U.S. or other countries could negatively impact our business by increasing costs, decreasing demand for our products, and increasing government cost controls, among other risks. For example, U.S. legislation has been introduced to limit certain U.S. biotechnology companies from using equipment or services from select Chinese biotechnology companies, and others in Congress have advocated for limitations on those Chinese service providers’ ability to engage in business in the U.S. We cannot predict what actions may ultimately be taken with respect to trade relations between the United States and China or other countries, what products and services may be subject to such actions, the effective date or duration of such actions, or what actions may be taken by the other countries in response to actions by the United States. If we are unable to obtain or use services from existing service providers or become unable to export or sell our products to any of our customers or service providers, our business could be materially and adversely affected.",
      "prior_body": "We maintain and rely extensively on information technology systems and network infrastructures for the effective operation of our business. In the course of our business, we collect, store, and transmit confidential information (including personal information and intellectual property), and it is critical that we do so in a secure manner to maintain the confidentiality, integrity, and availability of such confidential information. A disruption, infiltration, or failure of our information technology systems or any of our data centers as a result of software or hardware malfunctions, computer viruses, cyber-attacks, employee theft or misuse, power disruptions, natural disasters, floods or accidents could cause breaches of data security and loss of critical data, which in turn could materially adversely affect our business and subject us to both private and governmental causes of action. While we have implemented security measures to minimize these risks to our data and information technology systems and have adopted a business continuity plan to deal with a disruption to our information technology systems, there can be no assurance that our efforts to protect our data and information systems will prevent breakdowns or breaches in our systems that could adversely affect our business. In addition, we maintain cyber liability insurance, however, this insurance may not be sufficient to cover the financial, legal, business or reputational losses that may result from an interruption or breach of our systems and those of critical third parties. Cyber-attacks are increasing in their frequency, sophistication, and intensity, and are becoming increasingly difficult to detect. They are often carried out by well-resourced and skilled parties, including nation states, organized crime groups, “hacktivists” and employees or contractors acting carelessly or with malicious intent. Cyber-attacks include deployment of harmful malware and key loggers, ransomware, denial-of-service attacks, malicious websites, the use of social engineering, and other means to affect the confidentiality, integrity and availability of our technology systems and data. Cyber-attacks also include manufacturing, hardware or software supply chain attacks, which could cause a delay in the manufacturing of products or products produced for contract manufacturing or lead to a data privacy or security breach. Our business partners face similar risks and when they experience a security breach of their systems, our security can be adversely affected. Similar to other companies, we have experienced immaterial cybersecurity incidents, including temporary service interruptions of third-party suppliers. In addition, our increased use of cloud technologies heightens these third party and other operational risks, and any failure by cloud or other technology service providers to adequately safeguard their systems and prevent cyber-attacks could disrupt our operations and result in misappropriation, corruption, or loss of confidential or propriety information. A significant portion of our workforce continues to leverage hybrid work. Risk of cyber-attack is increased with employees working remotely. Remote work increases the risk we may be vulnerable to cybersecurity-related events such as phishing attacks and other security threats."
    },
    {
      "status": "MODIFIED",
      "current_title": "commercialization of our approved products.",
      "prior_title": "Our product candidates remain subject to clinical testing and regulatory approval, and our future success is dependent on our ability to successfully develop additional product candidates for both CF and non-CF indications.",
      "similarity_score": 0.558,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"Extensive testing is required for our product candidates and for new indications of our marketed products.\""
      ],
      "current_body": "Extensive testing is required for our product candidates and for new indications of our marketed products. The outcomes of such clinical and non-clinical testing are highly uncertain, may not generate sufficient safety, efficacy, or other data, and may not support regulatory approval of our product candidates. Clinical and non-clinical testing, and in particular our later- stage clinical trials, are expensive and resource intensive. The data from our preclinical studies and other research activities have in the past and may in the future fail to predict results in clinical trials. For example, despite considerable non-clinical testing, the clinical study of VX-264 in T1D did not meet its efficacy endpoint. Similarly, results from earlier-stage clinical 28trials may not be predictive of the results from later-stage clinical trials, or of the likelihood of approval of a product candidate for commercial sale. In addition, interim or preliminary data from a clinical trial may not be predictive of final results from the clinical trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment and treatment continues, more patient data become available, or as patients continue other treatments for their disease. The data from our clinical programs may not support approval or successful commercialization of our product candidates, and we may be unable to recoup the significant research and development, clinical trial, acquisition-related, and other expenses incurred, which could have an adverse effect on our business, financial condition and results of operations, and/or cause our stock price to decline or experience periods of volatility. In addition, results of our clinical trials and findings from nonclinical studies could lead to abrupt changes in our development activities, including the possible cessation of development activities associated with a particular product candidate or program. For example, after VX-264 did not meet its efficacy endpoint, we announced that the program would not advance into further clinical studies. Failure to advance product candidates through clinical development would impair our ability to commercialize products, which could materially harm our business, financial condition and long-term prospects. Our research and development activities are highly regulated, and it is possible that the FDA and other regulatory authorities: •pause or halt our clinical trials based on their assessment of the potential or actual risks of continuing;•disagree with our conclusions about the results from our clinical trials;•require additional clinical trials, including confirmatory trials, or disagree with our clinical trial design or endpoint; •fail to approve the facilities or processes used to manufacture a product candidate, or our dosing or delivery methods;•grant marketing approval that is more restricted than anticipated, including limiting indications to narrow patient populations and imposing safety monitoring requirements, or risk evaluation and mitigation strategies; •withdraw approval of a product or indication, including when the product or indication was approved under an accelerated approval pathway and confirmatory studies were unsuccessful.Furthermore, we periodically release new information, including clinical data, regarding our products and product candidates, which may affect investors’ perceptions regarding our products and product candidates, and cause our stock price to decline or experience periods of significant volatility. For example, our stock price decreased in August 2025 after we released Phase 2 data for VX-993 and informed investors that the FDA did not see a path toward a broad peripheral neuropathic pain label for suzetrigine at that time. The timing of the release of information by us regarding our product development programs is often beyond our control and is influenced by the timing of receipt of communications from regulators and data from our clinical trials, among other things.If we fail to successfully conduct our clinical activities, our clinical trials or future regulatory approvals may be delayed or denied.Conducting clinical trials is a complex, lengthy and expensive process. Our ability to complete clinical trials on our anticipated timelines depends on numerous factors, including proper and efficient protocol design, regulatory and institutional review board approval, adequate patient enrollment and retention rates, and compliance with current good clinical practices. Delays or complications in clinical trials may arise from difficulties in enrolling or retaining patients, competition from other clinical trials, the occurrence of significant and/or unexpected adverse safety events, changes in regulatory requirements, supply chain issues or disruptions at clinical trial sites. Further, we may face additional challenges identifying and enrolling sufficient patients for clinical trials for rare diseases and cell and gene therapies due to small patient populations. With respect to cell and genetic therapies there may be additional concerns regarding the safety of these more novel therapeutic approaches to the treatment of these diseases. If we or our third-party clinical trial providers, including contract research organizations (“CROs”), do not successfully conduct and manage our clinical activities or adequately comply with regulatory requirements, our clinical trials may experience delays or increased costs, and the potential regulatory approval of a product candidate or 28 28 28 trials may not be predictive of the results from later-stage clinical trials, or of the likelihood of approval of a product candidate for commercial sale. In addition, interim or preliminary data from a clinical trial may not be predictive of final results from the clinical trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment and treatment continues, more patient data become available, or as patients continue other treatments for their disease. The data from our clinical programs may not support approval or successful commercialization of our product candidates, and we may be unable to recoup the significant research and development, clinical trial, acquisition-related, and other expenses incurred, which could have an adverse effect on our business, financial condition and results of operations, and/or cause our stock price to decline or experience periods of volatility. In addition, results of our clinical trials and findings from nonclinical studies could lead to abrupt changes in our development activities, including the possible cessation of development activities associated with a particular product candidate or program. For example, after VX-264 did not meet its efficacy endpoint, we announced that the program would not advance into further clinical studies. Failure to advance product candidates through clinical development would impair our ability to commercialize products, which could materially harm our business, financial condition and long-term prospects. Our research and development activities are highly regulated, and it is possible that the FDA and other regulatory authorities: •pause or halt our clinical trials based on their assessment of the potential or actual risks of continuing;•disagree with our conclusions about the results from our clinical trials;•require additional clinical trials, including confirmatory trials, or disagree with our clinical trial design or endpoint; •fail to approve the facilities or processes used to manufacture a product candidate, or our dosing or delivery methods;•grant marketing approval that is more restricted than anticipated, including limiting indications to narrow patient populations and imposing safety monitoring requirements, or risk evaluation and mitigation strategies; •withdraw approval of a product or indication, including when the product or indication was approved under an accelerated approval pathway and confirmatory studies were unsuccessful.Furthermore, we periodically release new information, including clinical data, regarding our products and product candidates, which may affect investors’ perceptions regarding our products and product candidates, and cause our stock price to decline or experience periods of significant volatility. For example, our stock price decreased in August 2025 after we released Phase 2 data for VX-993 and informed investors that the FDA did not see a path toward a broad peripheral neuropathic pain label for suzetrigine at that time. The timing of the release of information by us regarding our product development programs is often beyond our control and is influenced by the timing of receipt of communications from regulators and data from our clinical trials, among other things.If we fail to successfully conduct our clinical activities, our clinical trials or future regulatory approvals may be delayed or denied.Conducting clinical trials is a complex, lengthy and expensive process. Our ability to complete clinical trials on our anticipated timelines depends on numerous factors, including proper and efficient protocol design, regulatory and institutional review board approval, adequate patient enrollment and retention rates, and compliance with current good clinical practices. Delays or complications in clinical trials may arise from difficulties in enrolling or retaining patients, competition from other clinical trials, the occurrence of significant and/or unexpected adverse safety events, changes in regulatory requirements, supply chain issues or disruptions at clinical trial sites. Further, we may face additional challenges identifying and enrolling sufficient patients for clinical trials for rare diseases and cell and gene therapies due to small patient populations. With respect to cell and genetic therapies there may be additional concerns regarding the safety of these more novel therapeutic approaches to the treatment of these diseases. If we or our third-party clinical trial providers, including contract research organizations (“CROs”), do not successfully conduct and manage our clinical activities or adequately comply with regulatory requirements, our clinical trials may experience delays or increased costs, and the potential regulatory approval of a product candidate or trials may not be predictive of the results from later-stage clinical trials, or of the likelihood of approval of a product candidate for commercial sale. In addition, interim or preliminary data from a clinical trial may not be predictive of final results from the clinical trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment and treatment continues, more patient data become available, or as patients continue other treatments for their disease. The data from our clinical programs may not support approval or successful commercialization of our product candidates, and we may be unable to recoup the significant research and development, clinical trial, acquisition-related, and other expenses incurred, which could have an adverse effect on our business, financial condition and results of operations, and/or cause our stock price to decline or experience periods of volatility. In addition, results of our clinical trials and findings from nonclinical studies could lead to abrupt changes in our development activities, including the possible cessation of development activities associated with a particular product candidate or program. For example, after VX-264 did not meet its efficacy endpoint, we announced that the program would not advance into further clinical studies. Failure to advance product candidates through clinical development would impair our ability to commercialize products, which could materially harm our business, financial condition and long-term prospects. Our research and development activities are highly regulated, and it is possible that the FDA and other regulatory authorities: •pause or halt our clinical trials based on their assessment of the potential or actual risks of continuing; •disagree with our conclusions about the results from our clinical trials; •require additional clinical trials, including confirmatory trials, or disagree with our clinical trial design or endpoint; •fail to approve the facilities or processes used to manufacture a product candidate, or our dosing or delivery methods; •grant marketing approval that is more restricted than anticipated, including limiting indications to narrow patient populations and imposing safety monitoring requirements, or risk evaluation and mitigation strategies; •withdraw approval of a product or indication, including when the product or indication was approved under an accelerated approval pathway and confirmatory studies were unsuccessful. Furthermore, we periodically release new information, including clinical data, regarding our products and product candidates, which may affect investors’ perceptions regarding our products and product candidates, and cause our stock price to decline or experience periods of significant volatility. For example, our stock price decreased in August 2025 after we released Phase 2 data for VX-993 and informed investors that the FDA did not see a path toward a broad peripheral neuropathic pain label for suzetrigine at that time. The timing of the release of information by us regarding our product development programs is often beyond our control and is influenced by the timing of receipt of communications from regulators and data from our clinical trials, among other things.",
      "prior_body": "Our business depends upon the successful development and commercialization of product candidates. These product candidates are in various stages of development and must satisfy rigorous standards of safety and efficacy before they can be approved for sale by the FDA or comparable foreign regulatory authorities. To satisfy these standards, we must allocate resources among our various development programs and must engage in expensive and lengthy testing of our product candidates. Discovery and development efforts for new pharmaceutical and biological products, including new combination therapies, are resource-intensive and may take 10 to 15 years or longer for each product candidate. It is impossible to predict when or if any of our product candidates will prove effective and safe in humans or will receive regulatory approval. Despite our efforts, our product candidates may not: •offer therapeutic or other improvement over existing competitive therapies; •show the level of safety and efficacy, including the level of statistical significance, required by the FDA or other regulatory authorities for approval of a drug or biologic; •meet applicable regulatory standards; •be capable of being produced in commercial quantities at acceptable costs; or •if approved for commercial sale, be successfully marketed as pharmaceutical or biological products. We have recently completed and/or have ongoing or planned clinical trials for several of our product candidates. The strength of our product portfolio and pipeline will depend in large part upon the outcomes of these clinical trials, including those evaluating TRIKAFTA/KAFTRIO and ALYFTREK in younger children with CF, VX-522 in CF, suzetrigine in peripheral neuropathic pain, VX-993 in acute and diabetic peripheral neuropathy, and zimislecel and VX-264 in T1D. Failure to advance product candidates through clinical development could impair our ability to ultimately commercialize products, which could materially harm our business and long-term prospects. Results of our clinical trials and findings from our nonclinical studies, including toxicology findings in nonclinical studies conducted concurrently with clinical trials, could lead to abrupt changes in our development activities, including the possible cessation of development activities associated with a particular product candidate or program. Moreover, clinical data are often susceptible to varying interpretations, and many companies that have believed their product candidates performed satisfactorily in clinical trials have nonetheless failed to obtain marketing approval of their product candidate. Furthermore, results from our clinical trials may not meet the level of statistical significance or otherwise 42 42 42 provide the level of evidence or safety and efficacy required by the FDA or other regulatory authorities for approval of a product candidate. Finally, clinical trials are expensive and require significant operational resources to implement and maintain. Many companies in the pharmaceutical and biotechnology industries, including our company, have suffered significant setbacks in later-stage clinical trials even after achieving promising results in earlier-stage clinical trials. For example, the results from completed preclinical studies and clinical trials may not be replicated in later clinical trials, and ongoing clinical trials for our product candidates may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood of approval of a product candidate for commercial sale. In addition, from time to time, we report interim, topline, and preliminary data from our clinical trials, which is based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change. Interim or preliminary data from a clinical trial may not be predictive of final results from the clinical trial and are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment and treatment continues and more patient data become available or as patients from our clinical trials continue other treatments for their disease. Topline data also remain subject to audit and verification procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. If the interim, topline, or preliminary data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our product candidates may be harmed, which could harm our business, operating results, prospects or financial condition. The ability of third parties to review and/or analyze data from our clinical trials, including as a result of government disclosure, also may increase the risk of commercial confidentiality breaches and result in enhanced scrutiny of our clinical trial results. For example, Clinical Trial Regulation (EU) No. 536/2014, and the EMA policy on publication of clinical data for medicinal products for human use, both permit the EMA to publish clinical information submitted in marketing authorization applications. Third party review and scrutiny could result in public misconceptions regarding our drugs and product candidates. These publications could also result in the disclosure of information to our competitors that we might otherwise deem confidential, which could harm our business."
    },
    {
      "status": "MODIFIED",
      "current_title": "Our business is substantially dependent on the success of our CF medicines.",
      "prior_title": "If we are unable to sustain and grow revenues from sales of our CF medicines, our business would be materially harmed and the market price of our common stock would likely decline.",
      "similarity_score": 0.554,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"Substantially all our net product revenues have been derived from the sale of our CF medicines.\""
      ],
      "current_body": "Substantially all our net product revenues have been derived from the sale of our CF medicines. We may be unable to sustain or increase revenues from sales of our CF medicines in the future for any number of reasons, including the potential introduction of competitive products or the inability to successfully develop and commercialize next-generation medications or medicines to treat people with CF who cannot benefit from our current CF medicines. Our concentrated source of revenue increases the risks associated with potential manufacturing or supply disruptions, safety issues that may be identified with respect to our CF medicines, and failure to gain and/or maintain market acceptance or adequate pricing or reimbursement for our CF medicines. If we are unable to sustain or increase revenues from sales of our CF medicines, or if we do not meet the expectations of investors, our business would be materially harmed and our ability to fund our operations could be adversely affected.",
      "prior_body": "Substantially all of our net product revenues have been derived from the sale of our CF medicines over the last several years. As a result, our business is dependent upon our ability to sustain and increase revenues from sales of our CF medicines. We seek to continue to increase our CF product revenue through serial innovation, including development and commercialization of next-generation CF medicines, extending access of CF medicines to younger children with CF, seeking additional approvals for our CF medicines in ex-U.S. markets and securing and maintaining adequate reimbursements for our CF medicines globally, and by developing a nebulized mRNA therapy for the more than 5,000 people with CF who do not make CFTR protein and cannot benefit from CFTR modulators. Our concentrated source of revenues presents a number of risks to our business, including: •that one or more competing therapies may be developed successfully by others as a treatment for people with CF; •that reimbursement policies of payors and other third parties may make it difficult to obtain reimbursement or may reduce the net price we receive for our products; •that we may experience manufacturing or supply disruptions for our CF medicines; and •that we may experience adverse developments with respect to development or commercialization of our CF medicines. Our ability to increase our CF product revenues is dependent in part on our ability to successfully commercialize ALYFTREK, our recently approved once-daily CF medicine. We expect the commercial opportunity for ALYFTREK to depend on three types of patients: (i) those who are currently on a CFTR modulator who may want to switch to ALYFTREK, (ii) those patients who have not yet been initiated on a CFTR modulator or been eligible for a CFTR modulator, and (iii) those who have discontinued from another CFTR modulator. There can be no assurance that people with CF will be willing to switch from their current CFTR modulator or initiate treatment with ALYFTREK if they are not currently being treated by a CFTR modulator. If any of the above risks were to materialize, if we are otherwise unable to increase revenues from sales of our CF medicines, or if we do not meet the expectations of investors or public equity market analysts, our business would be materially harmed and our ability to fund our operations could be adversely affected. 35 35 35"
    },
    {
      "status": "MODIFIED",
      "current_title": "Our business has a substantial risk of product liability claims and other litigation liability.",
      "prior_title": "Our business has a substantial risk of product liability claims and other litigation liability.",
      "similarity_score": 0.542,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"The testing, manufacturing, marketing and use of our products and product candidates involve substantial risk of product liability claims.\""
      ],
      "current_body": "The testing, manufacturing, marketing and use of our products and product candidates involve substantial risk of product liability claims. These claims may be made directly by consumers, patients, healthcare providers, or others. Product liability claims and lawsuits and safety alerts or product recalls, regardless of their ultimate outcome, may decrease demand for our products or any product candidate for which we obtain marketing approval, and may have a material adverse effect on our business, results of operations, reputation, and our ability to market our products. Our product liability and clinical trial insurance may not provide adequate coverage against all potential liabilities. There continues to be a significant volume of government and regulatory investigations and litigation against companies operating in our industry, as well as robust regulatory enforcement and whistleblower claims. Investigations into aspects of our business include inquiries, subpoenas, and other types of information demands from government and regulatory authorities. We are also involved in and are subject to other various legal proceedings, including litigation, and other dispute- related proceedings. These activities require significant financial and internal resources. This includes the arbitration initiated by the third party to whom the CFF has assigned its ALYFTREK royalty rights. Please see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K for more information. The outcome of such legal proceedings, investigations or any other dispute-related proceedings are inherently uncertain and adverse developments or outcomes can result in significant expenses, monetary damages, penalties, injunctions, or other relief against us, and in the ALYFTREK arbitration, could result in higher future costs of goods if royalty fees are higher than anticipated. For a description of our litigation, investigation and other dispute-related matters, see Note P., Commitments and Contingencies — Legal Matters and Other Contingencies, included in this Annual Report on Form 10-K.",
      "prior_body": "We are or may be involved in various legal proceedings, including securities/shareholder matters and claims related to product liability, intellectual property, employment law, competition law, data privacy, and breach of contract. Such proceedings may involve claims for, or the possibility of, damages or fines and penalties involving substantial amounts of money or other relief, including civil or criminal fines and penalties. If any of these legal proceedings were to result in an adverse outcome, it could have a material adverse effect on our business. For example, we pay royalties on certain sales of TRIKAFTA/KAFTRIO, SYMDEKO/SYMKEVI, KALYDECO, ORKAMBI and ALYFTREK pursuant to our agreement with the Cystic Fibrosis Foundation. The third-party to whom the Cystic Fibrosis Foundation has assigned rights to receive these royalty payments has made public statements related to the calculation of royalties associated with ALYFTREK. Based on the agreement between Vertex and the Cystic Fibrosis Foundation, we believe the third party is wrong. If any potential future adversarial proceedings were not resolved in our favor, however, we could be required to pay a higher royalty percentage on ALYFTREK sales than we currently expect, and our future cost of goods with respect to ALYFTREK could increase above our current expectations. The use of our approved products and our product candidates exposes us to the risk of product liability claims. Product liability claims may be brought against us by people participating in clinical trials, patients, healthcare providers, or others selling or coming in contact with our products or our product candidates. There is a risk that our products or our product candidates may induce adverse events. For instance, the product labels for TRIKAFTA and ALYFTREK include a boxed warning regarding liver injury and liver failure. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liability and costs, which could have a material adverse effect on our business or financial condition. In addition, regardless of merit or eventual outcome, product liability claims may result in: •Decreased demand for our approved products, such as TRIKAFTA and ALYFTREK, or any product candidate for which we obtain marketing approval; •Inability to successfully commercialize approved products; •Impairment of our business reputation and exposure to adverse publicity; •New or increased warnings on our product labels; •Withdrawal of clinical trial participants; 58 58 58 •Costs as a result of related litigation; •Distraction of management’s attention from our primary business; •Substantial monetary awards to patients or other claimants; and •Loss of revenue. We have product liability insurance and clinical trial insurance in amounts that we believe are adequate to cover this risk. However, our insurance may not provide adequate coverage against all potential liabilities. If a claim is brought against us, we might be required to pay legal and other expenses to defend the claim, as well as pay uncovered damage awards and these damages could be significant and have a material adverse effect on our financial condition. Furthermore, whether or not we are ultimately successful in defending any such claims, we might be required to direct significant financial and managerial resources to such defense and adverse publicity is likely to result."
    },
    {
      "status": "MODIFIED",
      "current_title": "There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable",
      "prior_title": "We have adopted provisions in our articles of organization and by-laws and are subject to Massachusetts corporate laws that may frustrate any attempt to remove or replace members of our board or to effectuate certain types of business combinations involving us.",
      "similarity_score": 0.533,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"In May 2025, our Board of Directors approved a share repurchase program pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock from time to time through open market or privately negotiated transactions, of which $618.5 million has been repurchased as of December 31, 2025.\"",
        "Reworded sentence: \"Massachusetts state law also prohibits us from engaging in specified business combinations with an interested stockholder, subject to certain exceptions, unless the combination is approved or consummated in a prescribed manner, and places 37 37 37 upon, among other factors, market conditions, our cash balances and potential future capital requirements, results of operations, financial condition, and other factors that we may deem relevant.\""
      ],
      "current_body": "prices. In May 2025, our Board of Directors approved a share repurchase program pursuant to which we are authorized to repurchase up to $4.0 billion of our common stock from time to time through open market or privately negotiated transactions, of which $618.5 million has been repurchased as of December 31, 2025. Our stock repurchases will depend 37upon, among other factors, market conditions, our cash balances and potential future capital requirements, results of operations, financial condition, and other factors that we may deem relevant. We can provide no assurance that we will repurchase stock at favorable prices, if at all.General Risk FactorsOur stock price is volatile.Our stock price is subject to significant fluctuations. From January 1, 2025 to December 31, 2025, our common stock traded between $362.50 and $519.68 per share. Our future stock price could be significantly and adversely affected by: •announcements or investor analyst commentary regarding the clinical development of our product candidates as new information, including efficacy and safety information becomes available; •our financial guidance and/or financial results, including quarterly and annual fluctuations resulting from factors such as the timing and amount of our revenues and expenses; and •other factors including the risks described in these “Risk Factors.” Fluctuations in our stock price can result in substantial losses for shareholders. Following periods of volatility in the market price of a company’s securities, shareholder derivative lawsuits and securities class action litigation are common. Such litigation, if instituted against us or our officers and directors, could result in substantial costs and other harm to our business.If we fail to attract and retain skilled employees, our business could be materially harmed.We must attract and retain highly qualified and trained scientists, as well as employees with experience in the development, manufacture, and commercialization of medicines, including biologic and cell and genetic therapies. We face intense competition for such talent from our competitors, other companies, academic institutions, and other organizations throughout our industry, especially with respect to employees with expertise in cell or genetic therapies. Our compensation program, including equity awards, may not be sufficient to retain employees, especially if our stock price declines or other employers offer more attractive opportunities. Our ability to commercialize our products and achieve our research and development objectives depends on our ability to respond effectively to these demands. If we are unable to hire and retain qualified personnel, our ability to advance our pipeline, commercialize our products, and achieve our business objectives could be materially adversely affected.The use of social media platforms presents risks and challenges. Social media is increasingly used by patients, advocacy groups, and other third parties to discuss our products and product candidates. Social media posts may include statements about efficacy or adverse events that could create reporting obligations or regulatory scrutiny. Our employees’ use of social media also presents risks, including potential noncompliance with legal or regulatory requirements, inappropriate disclosure of confidential information or personal information, and loss of intellectual property. In addition, misinformation, negative sentiment, or impersonation of our business on social media could cause reputational damage or otherwise harm our business. Failure to appropriately manage these risks could result in regulatory actions, liability, or other adverse consequences.We have adopted provisions in our articles of organization and by-laws and are subject to Massachusetts corporate laws that may frustrate any attempt to remove or replace members of our board or to effectuate certain types of business combinations involving us.Provisions of our articles of organization, by-laws and Massachusetts state laws may frustrate any attempt to remove or replace members of our current Board of Directors and may discourage certain types of business combinations involving us. Our by-laws allow the Board of Directors to adjourn any meetings of shareholders prior to the time the meeting has been convened. We may issue shares of any class or series of preferred stock in the future without shareholder approval and upon such terms as our Board of Directors may determine. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any class or series of preferred stock that may be issued in the future. Massachusetts state law also prohibits us from engaging in specified business combinations with an interested stockholder, subject to certain exceptions, unless the combination is approved or consummated in a prescribed manner, and places 37 37 37 upon, among other factors, market conditions, our cash balances and potential future capital requirements, results of operations, financial condition, and other factors that we may deem relevant. We can provide no assurance that we will repurchase stock at favorable prices, if at all.General Risk FactorsOur stock price is volatile.Our stock price is subject to significant fluctuations. From January 1, 2025 to December 31, 2025, our common stock traded between $362.50 and $519.68 per share. Our future stock price could be significantly and adversely affected by: •announcements or investor analyst commentary regarding the clinical development of our product candidates as new information, including efficacy and safety information becomes available; •our financial guidance and/or financial results, including quarterly and annual fluctuations resulting from factors such as the timing and amount of our revenues and expenses; and •other factors including the risks described in these “Risk Factors.” Fluctuations in our stock price can result in substantial losses for shareholders. Following periods of volatility in the market price of a company’s securities, shareholder derivative lawsuits and securities class action litigation are common. Such litigation, if instituted against us or our officers and directors, could result in substantial costs and other harm to our business.If we fail to attract and retain skilled employees, our business could be materially harmed.We must attract and retain highly qualified and trained scientists, as well as employees with experience in the development, manufacture, and commercialization of medicines, including biologic and cell and genetic therapies. We face intense competition for such talent from our competitors, other companies, academic institutions, and other organizations throughout our industry, especially with respect to employees with expertise in cell or genetic therapies. Our compensation program, including equity awards, may not be sufficient to retain employees, especially if our stock price declines or other employers offer more attractive opportunities. Our ability to commercialize our products and achieve our research and development objectives depends on our ability to respond effectively to these demands. If we are unable to hire and retain qualified personnel, our ability to advance our pipeline, commercialize our products, and achieve our business objectives could be materially adversely affected.The use of social media platforms presents risks and challenges. Social media is increasingly used by patients, advocacy groups, and other third parties to discuss our products and product candidates. Social media posts may include statements about efficacy or adverse events that could create reporting obligations or regulatory scrutiny. Our employees’ use of social media also presents risks, including potential noncompliance with legal or regulatory requirements, inappropriate disclosure of confidential information or personal information, and loss of intellectual property. In addition, misinformation, negative sentiment, or impersonation of our business on social media could cause reputational damage or otherwise harm our business. Failure to appropriately manage these risks could result in regulatory actions, liability, or other adverse consequences.We have adopted provisions in our articles of organization and by-laws and are subject to Massachusetts corporate laws that may frustrate any attempt to remove or replace members of our board or to effectuate certain types of business combinations involving us.Provisions of our articles of organization, by-laws and Massachusetts state laws may frustrate any attempt to remove or replace members of our current Board of Directors and may discourage certain types of business combinations involving us. Our by-laws allow the Board of Directors to adjourn any meetings of shareholders prior to the time the meeting has been convened. We may issue shares of any class or series of preferred stock in the future without shareholder approval and upon such terms as our Board of Directors may determine. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any class or series of preferred stock that may be issued in the future. Massachusetts state law also prohibits us from engaging in specified business combinations with an interested stockholder, subject to certain exceptions, unless the combination is approved or consummated in a prescribed manner, and places upon, among other factors, market conditions, our cash balances and potential future capital requirements, results of operations, financial condition, and other factors that we may deem relevant. We can provide no assurance that we will repurchase stock at favorable prices, if at all.",
      "prior_body": "Provisions of our articles of organization, by-laws and Massachusetts state laws may frustrate any attempt to remove or replace members of our current Board of Directors and may discourage certain types of business combinations involving us. Our by-laws allow the Board of Directors to adjourn any meetings of shareholders prior to the time the meeting has been convened. We may issue shares of any class or series of preferred stock in the future without shareholder approval and upon such terms as our Board of Directors may determine. The rights of the holders of common stock will be subject to, and may be adversely affected by, the rights of the holders of any class or series of preferred stock that may be issued in the future. Massachusetts state law also prohibits us from engaging in specified business combinations with an interested stockholder, subject to certain exceptions, unless the combination is approved or consummated in a prescribed manner, and places restrictions on voting by any shareholder who acquires 20% or more of the aggregate shareholder voting power without approval by non-interested shareholders. As a result, shareholders or other parties may find it difficult to remove or replace our directors or to effectuate certain types of business combinations involving us. 63 63 63"
    },
    {
      "status": "MODIFIED",
      "current_title": "If we fail to successfully conduct our clinical activities, our clinical trials or future regulatory approvals may be delayed or",
      "prior_title": "If regulatory authorities interpret any of our conduct, including our marketing practices, as being in violation of applicable health care laws, including fraud and abuse laws, laws prohibiting false and misleading promotion, disclosure laws or other similar laws, we may be subject to civil or criminal penalties.",
      "similarity_score": 0.468,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"Conducting clinical trials is a complex, lengthy and expensive process.\""
      ],
      "current_body": "denied. Conducting clinical trials is a complex, lengthy and expensive process. Our ability to complete clinical trials on our anticipated timelines depends on numerous factors, including proper and efficient protocol design, regulatory and institutional review board approval, adequate patient enrollment and retention rates, and compliance with current good clinical practices. Delays or complications in clinical trials may arise from difficulties in enrolling or retaining patients, competition from other clinical trials, the occurrence of significant and/or unexpected adverse safety events, changes in regulatory requirements, supply chain issues or disruptions at clinical trial sites. Further, we may face additional challenges identifying and enrolling sufficient patients for clinical trials for rare diseases and cell and gene therapies due to small patient populations. With respect to cell and genetic therapies there may be additional concerns regarding the safety of these more novel therapeutic approaches to the treatment of these diseases. If we or our third-party clinical trial providers, including contract research organizations (“CROs”), do not successfully conduct and manage our clinical activities or adequately comply with regulatory requirements, our clinical trials may experience delays or increased costs, and the potential regulatory approval of a product candidate or 29expansion of a label for a marketed product may be delayed or denied. Any delay in obtaining required regulatory approvals could adversely affect our ability to successfully commercialize a product candidate.Regulatory, Intellectual Property and Other Legal RisksThe extensive regulatory framework governing the health care industry could adversely affect our ability to obtain approval and market our medicines and failure to comply with these regulations could result in fines, penalties or other non-monetary remedies. The health care industry is highly regulated and subject to complex and increasing regulations. U.S. federal and state regulators, including the FDA and comparable ex-U.S. regulators directly regulate our most critical business activities, including those related to research, development, manufacturing, and commercialization, as described in Item 1, “Business – Government Regulation.” The process for obtaining regulatory approvals to market a product is costly and time consuming, and approvals may not be granted for future products, or additional indications of existing products, on a timely basis or at all. In addition, we cannot guarantee that we will remain compliant with applicable regulatory requirements once approval has been obtained. These requirements govern, among other things, our manufacturing practices, communications regarding our products, and reporting of safety events. Maintaining compliance with these extensive regulations is complex, expensive, and time consuming, and failure to comply may result in additional regulatory actions, including recalls, withdrawal or suspension of product approvals, civil and criminal charges, reputational harm, and fines, penalties, or other monetary or non-monetary remedies, including exclusion from receipt of payment from U.S. federal and state healthcare programs like Medicare and Medicaid. Compliance with the regulatory requirements for biologics and cell and gene therapies can be more burdensome, expensive and time-consuming than for other, better known or more extensively studied types of medicines, such as small molecules. Regulatory requirements governing cell and genetic therapy products have changed frequently and may continue to change in the future. Furthermore, risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic areas with different patient populations, which may require different commercialization activities from those we currently utilize. We expect that regulation of the healthcare industry will continue to evolve through political and legal action, as future proposals to reform healthcare systems are considered by U.S. and foreign governments and regulatory authorities. We cannot predict when additional changes in the healthcare industry in general, or the pharmaceutical industry in particular, will occur, or what the impact of such changes may be. For example, new proposals or requirements regarding local manufacturing of pharmaceutical products, enhanced data security and privacy measures, sustainability, importation restrictions, embargoes, or trade sanctions may negatively impact our business. In addition, our development and commercialization activities could be harmed or delayed by a shutdown of the U.S. government or events that affect the manner in which the FDA operates. Commercialization of our products requires that we operate in compliance with applicable health care laws, including laws regulating promotional activities, prohibiting fraud and abuse and requiring reporting of government pricing information.We market our products to health care providers and provide promotional materials and informational programs regarding the use of each product in these patient populations. In jurisdictions where permitted, we also market our products to patients for whom the applicable product has been approved, as well as to their caregivers. If a regulatory authority interprets any of our conduct, including our marketing practices or patient support programs, as promotion of unapproved uses or otherwise false and misleading, it could request that we modify or withdraw our promotional materials or issue corrective advertising. It could also take enforcement action, such as issuing warning or untitled letters, prohibiting certain of our activities, seizing products, and imposing civil fines and criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they believe that the alleged conduct led to the submission and payment of claims for unapproved uses of our product, which could result in significant fines or penalties. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters.Our interactions with health care providers that prescribe or purchase our products are also subject to laws and regulations designed to prevent fraud and abuse in the sale and use of medicines and that place significant restrictions on the marketing practices of biopharmaceutical companies. The relationships between companies and health care providers are 29 29 29 expansion of a label for a marketed product may be delayed or denied. Any delay in obtaining required regulatory approvals could adversely affect our ability to successfully commercialize a product candidate.Regulatory, Intellectual Property and Other Legal RisksThe extensive regulatory framework governing the health care industry could adversely affect our ability to obtain approval and market our medicines and failure to comply with these regulations could result in fines, penalties or other non-monetary remedies. The health care industry is highly regulated and subject to complex and increasing regulations. U.S. federal and state regulators, including the FDA and comparable ex-U.S. regulators directly regulate our most critical business activities, including those related to research, development, manufacturing, and commercialization, as described in Item 1, “Business – Government Regulation.” The process for obtaining regulatory approvals to market a product is costly and time consuming, and approvals may not be granted for future products, or additional indications of existing products, on a timely basis or at all. In addition, we cannot guarantee that we will remain compliant with applicable regulatory requirements once approval has been obtained. These requirements govern, among other things, our manufacturing practices, communications regarding our products, and reporting of safety events. Maintaining compliance with these extensive regulations is complex, expensive, and time consuming, and failure to comply may result in additional regulatory actions, including recalls, withdrawal or suspension of product approvals, civil and criminal charges, reputational harm, and fines, penalties, or other monetary or non-monetary remedies, including exclusion from receipt of payment from U.S. federal and state healthcare programs like Medicare and Medicaid. Compliance with the regulatory requirements for biologics and cell and gene therapies can be more burdensome, expensive and time-consuming than for other, better known or more extensively studied types of medicines, such as small molecules. Regulatory requirements governing cell and genetic therapy products have changed frequently and may continue to change in the future. Furthermore, risks relating to compliance with laws and regulations may be heightened as we continue to expand our global operations and enter new therapeutic areas with different patient populations, which may require different commercialization activities from those we currently utilize. We expect that regulation of the healthcare industry will continue to evolve through political and legal action, as future proposals to reform healthcare systems are considered by U.S. and foreign governments and regulatory authorities. We cannot predict when additional changes in the healthcare industry in general, or the pharmaceutical industry in particular, will occur, or what the impact of such changes may be. For example, new proposals or requirements regarding local manufacturing of pharmaceutical products, enhanced data security and privacy measures, sustainability, importation restrictions, embargoes, or trade sanctions may negatively impact our business. In addition, our development and commercialization activities could be harmed or delayed by a shutdown of the U.S. government or events that affect the manner in which the FDA operates. Commercialization of our products requires that we operate in compliance with applicable health care laws, including laws regulating promotional activities, prohibiting fraud and abuse and requiring reporting of government pricing information.We market our products to health care providers and provide promotional materials and informational programs regarding the use of each product in these patient populations. In jurisdictions where permitted, we also market our products to patients for whom the applicable product has been approved, as well as to their caregivers. If a regulatory authority interprets any of our conduct, including our marketing practices or patient support programs, as promotion of unapproved uses or otherwise false and misleading, it could request that we modify or withdraw our promotional materials or issue corrective advertising. It could also take enforcement action, such as issuing warning or untitled letters, prohibiting certain of our activities, seizing products, and imposing civil fines and criminal penalties. It is also possible that other federal, state, or foreign enforcement authorities might take action if they believe that the alleged conduct led to the submission and payment of claims for unapproved uses of our product, which could result in significant fines or penalties. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters.Our interactions with health care providers that prescribe or purchase our products are also subject to laws and regulations designed to prevent fraud and abuse in the sale and use of medicines and that place significant restrictions on the marketing practices of biopharmaceutical companies. The relationships between companies and health care providers are expansion of a label for a marketed product may be delayed or denied. Any delay in obtaining required regulatory approvals could adversely affect our ability to successfully commercialize a product candidate.",
      "prior_body": "We are subject to health care fraud and abuse laws, such as the FCA and the AKS, and other similar laws and regulations both in the U.S. and in non-U.S. markets. In the U.S., the Federal Anti-Kickback Statute prohibits knowingly and willfully offering, paying, soliciting, receiving or providing remuneration, directly or indirectly, in exchange for or to induce either the referral of an individual, or the ordering, furnishing, arranging for or recommending of an item or service that is reimbursable, in whole or in part, by a federal health care program, such as Medicare or Medicaid. Because of the broad scope of the prohibition, most financial interactions between pharmaceutical manufacturers and prescribers, purchasers, third party payors and patients would be subject to the statute. Although there are a number of statutory exceptions and regulatory safe harbors protecting certain common activities from prosecution, financial interactions must be structured carefully to qualify for protection or otherwise withstand scrutiny. Federal false claims laws, including the FCA, prohibit any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government, or knowingly making, or causing to be made, a false statement to get a false claim paid. Pharmaceutical companies have been prosecuted under these laws for a variety of alleged promotional and marketing activities, such as providing free product to customers with the expectation that the customers would bill federal programs for the product; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in promotion for uses that the FDA has not approved, that caused claims to be submitted to Medicaid for those unapproved uses; submitting inflated “best price” information to the Medicaid Rebate Program; and certain manufacturing-related violations. The scope of this and other laws may expand in ways that make compliance more difficult and expensive. The FDA and other regulatory agencies closely regulate the post-approval marketing and promotion of products to ensure that they are marketed only for the approved indications and in accordance or consistent with the provisions of the approved labeling. Although physicians are generally permitted, based on their medical judgment, to prescribe products for indications other than those approved by the applicable regulatory agency, manufacturers are prohibited from promoting such unapproved uses. We market our products to eligible people with CF, SCD, TDT, and acute pain for whom the applicable product has been approved and provide promotional materials and informational programs to physicians regarding the use of each product in these patient populations. These eligible people do not represent all people with CF, SCD, TDT, and acute pain. If a regulatory agency determines that our promotional materials, or other activities constitute promotion of unapproved uses or otherwise false and misleading promotion, it could request that we modify our promotional materials or other activities, conduct corrective advertising, or subject us to regulatory enforcement actions, such as the issuance of a warning or untitled letter, injunction, seizure, civil fines and criminal penalties. It also is possible that other federal, state, or foreign enforcement authorities might take action if they believe that the alleged improper promotion led to the submission and payment of claims for an unapproved use, which could result in significant fines or penalties under other statutory authorities, such as laws prohibiting false claims for reimbursement. Even if it is later determined we were not in violation of these laws, we may be faced with negative publicity, incur significant expenses defending our actions, and have to divert significant management resources from other matters. In the U.S., federal and state laws regulate financial interactions between pharmaceutical manufacturers and healthcare providers, require disclosure to government authorities and the public of such interactions, and mandate the adoption of compliance standards or programs. For example, the so-called federal “sunshine law” requires pharmaceutical manufacturers to report annually to CMS payments or other transfers of value made by that entity to physicians, physicians assistants, advanced practice registered nurses, and teaching hospitals. We also have similar reporting obligations with respect to financial interactions throughout the E.U. We expended significant efforts to establish, and are continuing to devote significant resources to maintain and enhance, systems and processes to comply with these regulations. Requirements to track and disclose financial interactions with health care providers and organizations increase government and public scrutiny of these financial interactions. As we commercialize products in areas with broader patient populations, we will have more 46 46 46 interactions with a broader set of healthcare practitioners. Failure to comply with the reporting requirements could result in significant civil monetary penalties. The sales and marketing practices of our industry have been the subject of increased scrutiny from government authorities in the U.S. and other countries in which we market our products, and we believe that this trend will continue. Many of these laws have not been fully interpreted by the government authorities or the courts, and their provisions are subject to a variety of interpretations. While we have a corporate compliance program which, together with our policies and procedures, is designed to actively identify, prevent and mitigate risk through the implementation of compliance policies and systems and the promotion of a culture of compliance, if we are found not to be in full compliance with these laws and regulations, our business could be materially harmed. We may be subject to penalties, including civil and criminal penalties, damages, fines, exclusion from federal health care programs and/or the curtailment or restructuring of our operations. Even if we successfully defend against government challenge, responding to the challenge may cause us to incur significant legal expenses and divert our management’s attention from the operation of our business."
    },
    {
      "status": "MODIFIED",
      "current_title": "If we are unable to obtain, maintain and enforce our intellectual property rights, our business could be harmed.",
      "prior_title": "We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could adversely affect our business, result in fines and/or criminal penalties, and damage our reputation.",
      "similarity_score": 0.451,
      "confidence": "low",
      "key_changes": [
        "Reworded sentence: \"Our success depends, in significant part, on our ability to obtain, maintain, and enforce patents and intellectual property rights such as trademarks and copyrights that protect our products, product candidates, and technologies.\""
      ],
      "current_body": "Our success depends, in significant part, on our ability to obtain, maintain, and enforce patents and intellectual property rights such as trademarks and copyrights that protect our products, product candidates, and technologies. In addition, we rely upon trade secret protection and contractual arrangements to protect certain of our proprietary information. Due to the complexity of the legal standards and factual questions relating to the patentability, validity, and enforceability of patents covering pharmaceutical and biotechnological inventions and the scope of claims made under these patents, our ability to obtain, maintain and enforce our patents is uncertain. The initial grant of patents or regulatory exclusivity in the U.S. and ex- U.S. markets depends upon decisions of the patent offices, courts, and governments in those countries. We may fail to obtain, defend or otherwise preserve patent and other intellectual property rights, including certain forms of regulatory exclusivity, and our current intellectual property rights or protections and those we obtain in the future may not be broad enough or sufficient to protect our commercial interests in all countries where we conduct business. In the U.S. and ex-U.S. markets, third parties have challenged and may continue to challenge, invalidate, or circumvent our patents and patent applications relating to our products, product candidates, and technologies. We have had and may continue to have disputes with respect to the rights to products, product candidates, and technologies developed in collaboration with other parties. If we cannot resolve disputes and obtain adequate intellectual property right protections, we may not be able to develop or market our products. Settlements of such proceedings could also result in reducing the period of exclusivity and other protections, resulting in a reduction in revenue from affected products. Any litigation, including litigation related to Abbreviated New Drug Applications (“ANDA”), litigation related to 505(b)(2) applications, interference proceedings to determine priority of inventions, derivations proceedings, inter partes review, oppositions to patents in foreign countries, litigation against our collaborators, or similar actions, could harm our business. Difficulties in, or preclusion from, protecting our intellectual property rights in foreign jurisdictions could substantially harm our business. Third-party manufacturers may be able to sell generic versions of our products in countries that do not provide effective mechanisms for enforcement of our patents or other intellectual property rights. For example, we have experienced a violation of our intellectual property rights in Russia, where a copy product that infringes our patents has been made available. In addition, many foreign countries have compulsory licensing laws under which a patent owner must grant licenses to third parties in certain circumstances. Compulsory licenses have been used in certain countries for market access purposes and, in some cases, as a cost-containment measure. Compulsory licenses issued for our patents may diminish or reduce revenue from those jurisdictions and negatively affect our results of operations. Third parties may also illegally distribute and sell counterfeit versions of our products. Copy or counterfeit products may not meet our rigorous manufacturing and testing standards and a patient who receives such product may be at risk for a number of dangerous health consequences. Our business and reputation could suffer harm as a result of illegally produced and distributed generic versions of our products, as well as counterfeit products sold under our brand name. The diversion of products from their authorized market into other channels may result in reduced revenues and negatively affect our profitability. 31If we are not able to operate without infringing upon intellectual property rights of third parties, our business could be harmed.Our competitors seek to protect their products, product candidates and proprietary information through patents, trademarks, trade secrets, and copyrights. Third parties have claimed and may claim in the future that our products or other activities infringe their intellectual property rights or that our employees have misappropriated their intellectual property rights. See also Item 1., Business – Intellectual Property of this Annual Report on Form 10-K. Resolving an intellectual property infringement or other claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms. A successful claim of patent infringement or other violation or misappropriation of intellectual property rights by a third party could subject us to significant damages and/or an injunction preventing the manufacture, sale, or use of the affected product or products, and/or require us to pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.Our business has a substantial risk of product liability claims and other litigation liability. The testing, manufacturing, marketing and use of our products and product candidates involve substantial risk of product liability claims. These claims may be made directly by consumers, patients, healthcare providers, or others. Product liability claims and lawsuits and safety alerts or product recalls, regardless of their ultimate outcome, may decrease demand for our products or any product candidate for which we obtain marketing approval, and may have a material adverse effect on our business, results of operations, reputation, and our ability to market our products. Our product liability and clinical trial insurance may not provide adequate coverage against all potential liabilities. There continues to be a significant volume of government and regulatory investigations and litigation against companies operating in our industry, as well as robust regulatory enforcement and whistleblower claims. Investigations into aspects of our business include inquiries, subpoenas, and other types of information demands from government and regulatory authorities. We are also involved in and are subject to other various legal proceedings, including litigation, and other dispute-related proceedings. These activities require significant financial and internal resources. This includes the arbitration initiated by the third party to whom the CFF has assigned its ALYFTREK royalty rights. Please see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K for more information. The outcome of such legal proceedings, investigations or any other dispute-related proceedings are inherently uncertain and adverse developments or outcomes can result in significant expenses, monetary damages, penalties, injunctions, or other relief against us, and in the ALYFTREK arbitration, could result in higher future costs of goods if royalty fees are higher than anticipated. For a description of our litigation, investigation and other dispute-related matters, see Note P., Commitments and Contingencies — Legal Matters and Other Contingencies, included in this Annual Report on Form 10-K.We are subject to various and evolving laws and regulations governing the privacy and security of personal data.We are subject to a variety of evolving and developing data privacy and security laws and regulations in various jurisdictions related to the collection, storage, use, sharing, and security of personal data, including health information. Regulators globally are imposing data privacy and security requirements, such as the E.U.’s GDPR and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act. These and other similar types of laws and regulations that have been or may be passed often include requirements with respect to personal information. Compliance with privacy laws and regulations is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices. Failure to comply may result in liability through government enforcement, private actions, civil and criminal fines and penalties, litigation, and reputational harm. Although we are not directly subject to HIPAA, we could face penalties, including criminal liability, for knowingly obtaining or disclosing protected health information from non-compliant HIPAA-covered entities. The commercialization of cell and genetic therapies involves processing more personal data than traditional therapies, increasing our risk exposure. Furthermore, the number of government investigations, enforcement actions, and class action lawsuits related to data security incidents and privacy violations, particularly focused on online data sharing, continue to increase. Government investigations typically require significant resources and generate negative publicity, which could harm our business and reputation. 31 31 31 If we are not able to operate without infringing upon intellectual property rights of third parties, our business could be harmed.Our competitors seek to protect their products, product candidates and proprietary information through patents, trademarks, trade secrets, and copyrights. Third parties have claimed and may claim in the future that our products or other activities infringe their intellectual property rights or that our employees have misappropriated their intellectual property rights. See also Item 1., Business – Intellectual Property of this Annual Report on Form 10-K. Resolving an intellectual property infringement or other claim can be costly and time consuming and may require us to enter into license agreements, which may not be available on commercially reasonable terms. A successful claim of patent infringement or other violation or misappropriation of intellectual property rights by a third party could subject us to significant damages and/or an injunction preventing the manufacture, sale, or use of the affected product or products, and/or require us to pay royalties or redesign our infringing products, which may be impossible or require substantial time and monetary expenditure.Our business has a substantial risk of product liability claims and other litigation liability. The testing, manufacturing, marketing and use of our products and product candidates involve substantial risk of product liability claims. These claims may be made directly by consumers, patients, healthcare providers, or others. Product liability claims and lawsuits and safety alerts or product recalls, regardless of their ultimate outcome, may decrease demand for our products or any product candidate for which we obtain marketing approval, and may have a material adverse effect on our business, results of operations, reputation, and our ability to market our products. Our product liability and clinical trial insurance may not provide adequate coverage against all potential liabilities. There continues to be a significant volume of government and regulatory investigations and litigation against companies operating in our industry, as well as robust regulatory enforcement and whistleblower claims. Investigations into aspects of our business include inquiries, subpoenas, and other types of information demands from government and regulatory authorities. We are also involved in and are subject to other various legal proceedings, including litigation, and other dispute-related proceedings. These activities require significant financial and internal resources. This includes the arbitration initiated by the third party to whom the CFF has assigned its ALYFTREK royalty rights. Please see Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations of this Annual Report on Form 10-K for more information. The outcome of such legal proceedings, investigations or any other dispute-related proceedings are inherently uncertain and adverse developments or outcomes can result in significant expenses, monetary damages, penalties, injunctions, or other relief against us, and in the ALYFTREK arbitration, could result in higher future costs of goods if royalty fees are higher than anticipated. For a description of our litigation, investigation and other dispute-related matters, see Note P., Commitments and Contingencies — Legal Matters and Other Contingencies, included in this Annual Report on Form 10-K.We are subject to various and evolving laws and regulations governing the privacy and security of personal data.We are subject to a variety of evolving and developing data privacy and security laws and regulations in various jurisdictions related to the collection, storage, use, sharing, and security of personal data, including health information. Regulators globally are imposing data privacy and security requirements, such as the E.U.’s GDPR and other domestic data privacy and security laws, such as the California Consumer Privacy Act and the California Privacy Rights Act. These and other similar types of laws and regulations that have been or may be passed often include requirements with respect to personal information. Compliance with privacy laws and regulations is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices. Failure to comply may result in liability through government enforcement, private actions, civil and criminal fines and penalties, litigation, and reputational harm. Although we are not directly subject to HIPAA, we could face penalties, including criminal liability, for knowingly obtaining or disclosing protected health information from non-compliant HIPAA-covered entities. The commercialization of cell and genetic therapies involves processing more personal data than traditional therapies, increasing our risk exposure. Furthermore, the number of government investigations, enforcement actions, and class action lawsuits related to data security incidents and privacy violations, particularly focused on online data sharing, continue to increase. Government investigations typically require significant resources and generate negative publicity, which could harm our business and reputation.",
      "prior_body": "We are subject to data privacy and security laws and regulations in various jurisdictions that apply to the collection, storage, use, sharing, and security of personal data, including health information, and impose significant compliance obligations. In addition, numerous other federal and state laws, including state security breach notification laws, state health information privacy laws and federal and state consumer protection laws, govern the collection, use, disclosure and security 48 48 48 of personal information. The legislative and regulatory landscape for privacy and data protection continues to evolve, and there has been an increasing focus on privacy and data protection issues with the potential to affect our business. As we enter into new disease areas and jurisdictions both commercially and for clinical trials, we must continue to evaluate new and evolving privacy laws. For example, the E.U. General Data Protection Regulation (“GDPR”) went into effect in 2018 and has imposed new obligations on us with respect to our processing of personal data and the cross-border transfer of such data, including higher standards of obtaining consent, more robust transparency requirements, data breach notification requirements, requirements for contractual language with our data processors, and stronger individual data rights. Different E.U. member states have interpreted the GDPR differently and many have imposed additional requirements, which add to the complexity of processing personal data in the E.U. The GDPR also imposes strict rules on the transfer of personal data to countries outside the E.U., including the U.S. and the U.K., and permits data protection authorities to impose large penalties for violations of the GDPR. Similarly, other jurisdictions have either introduced or enacted legislation or executive orders restricting cross-border data transfers. These regulations restrict the transfer of certain types of data (e.g., sensitive personal data) or restrict the transfer of data to certain jurisdictions. The rules related to cross border data transfers continue to evolve based on court decisions and regulator guidance, which presents certain practical challenges to compliance. Regulators also continue to focus enforcement efforts on behavioral advertising and other online tracking technologies commonly used by companies. Compliance with these evolving rules is challenging, as country specific guidance and rules are continually changing and limited alternatives currently exist in the market. Compliance with the these laws and regulations is a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with any activities falling within the scope of the GDPR or other privacy laws or regulations. In the U.S., numerous states have introduced or enacted comprehensive privacy legislation. Similar to the California Consumer Rights Act, which came into effect in January 2023), these comprehensive privacy laws place numerous obligations on businesses with respect to the collection and processing of personal data. Some states have passed privacy legislation focusing specifically on the collection and processing of consumer health data. Enforcement at the federal level in the U.S. from the FTC has been focused on the use of health information for targeted advertising. While we continue to address the implications of the new data privacy regulations, data privacy remains an evolving landscape at both the domestic and international level, with new regulations coming into effect and continued legal challenges. Each law is also subject to various interpretations by courts and regulatory agencies, creating even more uncertainty. While we have a global privacy program that addresses such laws and regulations, our efforts to comply with the evolving data protection rules may be unsuccessful. We must devote significant resources to understanding and complying with the changing landscape in this area. Failure to comply with data protection laws may expose us to risk of enforcement actions taken by data protection authorities, private rights of action in some jurisdictions, and potential significant penalties if we are found to be non-compliant. Failure to comply with the GDPR and applicable national data protection laws of European Economic Area member states could lead to fines of up to €20,000,000 or up to 4% of the total worldwide annual revenue of the preceding financial year, whichever is higher. Some of these laws and regulations also carry the possibility of criminal sanctions. For example, while we are not directly subject to the Health Insurance Portability and Accountability Act of 1996, as amended by the Health Information Technology for Economic and Clinical Health Act (“HIPAA”), we could be subject to penalties, including criminal penalties if we knowingly obtain or disclose individually identifiable health information from a HIPAA-covered health care provider or research institution that has not complied with HIPAA’s requirements for disclosing such information. In addition, the commercialization of cell and gene therapies requires the collection and processing of a greater amount of personal data than traditional therapies, potentially increasing risk. Furthermore, the number of government investigations and enforcement actions related to data security incidents and privacy violations, with a specific focus on online data sharing, continue to increase and government investigations typically require significant resources and generate negative publicity, which could harm our business and our reputation."
    }
  ]
}