Classification is based on semantic text similarity scoring and may include approximations. “No match” means no high-confidence textual match was found — not necessarily that a section was removed.
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We may not be able to increase or maintain CASGEVY product revenues.
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revenues, and results of operations.
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Competing products and technological advances from our competitors may negatively affect our business and market
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non-monetary remedies.
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information.
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If we are not able to operate without infringing upon intellectual property rights of third parties, our business could be
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including at our third-party providers.
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product candidates and manufacture our products would be harmed.
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Reliance on third-party relationships could adversely affect our business.
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adversely affect our business.
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may be delays or failures in realizing the anticipated benefits of these activities.
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of operations and financial condition.
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Our stock price is volatile.
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SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
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ISSUER PURCHASES OF EQUITY SECURITIES
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Issuer Repurchases of Equity Securities
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Programs (1)
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Financial Highlights
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Business Updates
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Our Business Environment
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Strategic Transactions
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Total Revenues
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(in millions, except percentages)
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(in millions, except percentages)
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Operating Costs and Expenses
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(in millions, except percentages)
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(in millions, except percentages)
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(in millions, except percentages)
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(in millions, except percentages)
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(in millions, except percentages)
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(in millions, except percentages)
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Non-Operating Income (Expense), Net
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LIQUIDITY AND CAPITAL RESOURCES
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(in millions, except percentages)
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Working Capital
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(in millions)
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Sources and Uses of Liquidity
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Future Capital Requirements
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CRITICAL ACCOUNTING POLICIES AND ESTIMATES
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Revenue Recognition
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(in millions)
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Acquisitions
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Pre-Launch Inventories
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Income Taxes
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RECENT ACCOUNTING PRONOUNCEMENTS
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Interest Rate Risk
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Foreign Exchange Market Risk
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FINANCIAL DISCLOSURE
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(2) Management’s Annual Report on Internal Control Over Financial Reporting. Management is responsible for
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(4) Report of Independent Registered Public Accounting Firm
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Opinion on Internal Control Over Financial Reporting
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Basis for Opinion
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Definition and Limitations of Internal Control Over Financial Reporting
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Subject to Trading
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RELATED STOCKHOLDER MATTERS
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this Form 10-K
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Governance Documents
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Stock Certificate
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Collaboration Agreement
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SEC File/Reg. Number
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Financing Agreements
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Equity Plans
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Agreements with Executive Officers and Directors
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SEC File/Reg. Number
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Insider Trading Policy
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Subsidiaries
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Certifications
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Clawback Policy
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SEC File/Reg. Number
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Vertex Pharmaceuticals Incorporated
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Report of Independent Registered Public Accounting Firm
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Opinion on the Financial Statements
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Basis for Opinion
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Critical Audit Matter
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Medicaid Drug Rebate Program in the U.S.
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(in millions, except per share amounts)
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Year Ended December 31,
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(in millions)
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Year ended December 31,
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(in millions, except share and per share data)
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December 31,
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Liabilities and Shareholders’ Equity
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(in millions)
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Balance at December 31, 2022
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Balance at December 31, 2023
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Balance at December 31, 2024
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Balance at December 31, 2025
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(in millions)
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Year Ended December 31,
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Notes to Consolidated Financial Statements
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Nature of Business and Accounting Policies
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SUMMARY OF RISK FACTORS
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Risks Related to Our Business
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Risks Related to Pricing of Our Products
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Risks Related to Development and Clinical Testing of Our Products and Product Candidates
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Risks Related to Government Regulation
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Risks Related to Supply, Manufacturing and Reliance on Third Parties
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Risks Related to Business Development Activities
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Risks Related to Intellectual Property
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Risks Related to Our Operations
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Risks Related to Financial Results and Holding Our Common Stock
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If we are unable to successfully develop, obtain approval and commercialize treatments for acute and neuropathic pain, our business could be materially harmed.
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If we are not successful in commercializing CASGEVY, our revenue growth could be limited and our business could be materially harmed.
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If our competitors bring products with superior product profiles to market, our products may not be competitive, and our revenues could decline.
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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.
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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.
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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.
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We may experience pricing pressure on our products, which could reduce our revenues and future profitability.
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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.
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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.
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Insurance coverage and reimbursement of cell and genetic therapies is uncertain.
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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.
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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.
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Difficulty in enrolling patients could delay or prevent clinical trials of our product candidates, and ultimately delay or prevent regulatory approval.
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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.
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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.
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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.
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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.
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If we do not comply with laws regulating the protection of the environment and health and human safety, our business could be adversely affected.
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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.
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We face risks in connection with existing and future collaborations with respect to the development, manufacture and commercialization of our products and product candidates.
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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.
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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.
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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.
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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.
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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.
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A variety of risks associated with operating in foreign countries could materially adversely affect our business.
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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.
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Our stock price may fluctuate.
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Our quarterly operating results are subject to significant fluctuation.
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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.
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Issuances of additional shares of our common stock could cause the price of our common stock to decline.
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There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable prices.
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combinations involving us.
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taxable income.
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occurring at our facilities.
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If we fail to scale our operations to accommodate growth, our business may suffer.
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impose restrictions on our business.
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We are subject to various and evolving laws and regulations governing the privacy and security of personal data.
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If we fail to attract and retain skilled employees, our business could be materially harmed.
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The use of social media platforms presents risks and challenges.
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Our success depends on our ability to develop and commercialize additional medicines.
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negatively affected, the approved product could lose its approval, and our business could be materially harmed.
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A variety of risks associated with operating in foreign countries could materially adversely affect our business.
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commercialization of our approved products.
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Our business is substantially dependent on the success of our CF medicines.
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Our business has a substantial risk of product liability claims and other litigation liability.
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There can be no assurance that we will repurchase shares of common stock or that we will repurchase shares at favorable
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If we fail to successfully conduct our clinical activities, our clinical trials or future regulatory approvals may be delayed or
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If we are unable to obtain, maintain and enforce our intellectual property rights, our business could be harmed.
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