Moderna Inc.: 10-K Risk Factor Changes

2026 vs 2025 · SEC EDGAR · 2026-05-22

Other years: 2025 vs 2024 · 2024 vs 2023

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The summary below was generated by an AI language model and may contain errors or omissions. All other content on this page is deterministically extracted from the original SEC EDGAR filing.

Moderna's risk disclosure shifted focus from product-specific execution challenges (removing risks on COVID/RSV market dynamics and vaccine variant updates) toward broader regulatory and macroeconomic pressures, adding risks related to reference pricing legislation, tariff policies, and credit agreement compliance. The company substantially elevated emphasis on strategic alliance execution and near-term pipeline delivery, with 23 modified risks reflecting deeper articulation of partnership dependencies and commercialization uncertainties. Overall, the 79 total risks (compared to 76 in 2025) signal a rebalancing from pandemic-era operational concerns toward systemic policy and partnership risks.

✓ Deterministic extraction — no AI-generated data

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.

New Risks

Removed

Modified

Unchanged

🟢 New in Current Filing

Regulatory and market uncertainty have and may continue to impact our business and the markets for our products.

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Our ability to successfully commercialize our approved vaccines and any future products depends in part on evolving regulatory requirements, public health recommendations and market acceptance. In 2025, changes at U.S. regulatory agencies impacted policies and priorities related to our industry. For example, changes in FDA regulatory policies, post-marketing safety monitoring, and evidentiary expectations, as well as CDC and Advisory Committee on Immunization Practices (ACIP) recommendations regarding eligibility, target populations, and vaccination practices, may have affected and may continue to affect demand for our vaccines. Some of these changes, including new post-marketing commitments, have impacted and may in the future impact our costs. Ongoing regulatory uncertainty and evolving regulatory and public health guidance could impact future approvals, advisory committee recommendations, acceptance and demand for our existing or future products. Vaccination rates in the future may also be lower than our expectations due to other factors, including viral evolution, medical need and consumer motivation to vaccinate. These and other factors may make it difficult to accurately forecast vaccination rates for our products. If demand for COVID vaccines continues to decline, we lose significant market share, or our products are subject to significant competitive pricing pressure, our product sales may not materialize consistent with our projections. Beyond COVID, we have experienced challenges in the RSV market, in part due to advisory committee recommendations that were more limited than anticipated. Furthermore, our decisions regarding seasonal vaccine development, including for COVID-19, will be informed by annual guidance from the FDA and foreign regulators, which may impact the timing of development for our COVID vaccines. Different regulators have in the past and may in the future issue varying guidance regarding vaccine composition or populations who should receive a vaccine. Additionally, if our efforts to develop variant-specific vaccines are delayed or not as successful as our competitors’, we could suffer reputational harm, loss of market share and adverse financial results. We may expend significant resources adapting our vaccines or conducting clinical trials to protect against variants, but a market for our adapted vaccines may fail to develop or demand may not align with our projections or cost expenditures.

🟢 New in Current Filing We may experience difficulties executing our near-term strategy and prioritized pipeline. 🔒

🟢 New in Current Filing Federal legislative and regulatory efforts to implement reference pricing or most-favored-nation pricing models and other, similar regulatory actions could impact our product revenues and materially harm our business. 🔒

🟢 New in Current Filing Although we have obtained rare pediatric disease designation for mRNA-3927, we may not be eligible to receive a priority review voucher in the event the FDA determines we no longer meet the criteria for designation, revokes the designation or FDA approval does not occur by September 30, 2029. 🔒

🟢 New in Current Filing Failure to comply with the covenants in our credit agreement could adversely affect our business 🔒

🟢 New in Current Filing Changes in tariffs and other governmental trade policies could negatively affect our business and results of operations. 🔒

🔴 No Match in Current Filing Uncertainty and evolving dynamics in the markets for COVID and RSV vaccines, and respiratory vaccines more generally, have in the past impacted and are likely to continue to impact our financial results. 🔒

🔴 No Match in Current Filing We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts. 🔒

🔴 No Match in Current Filing We may be unsuccessful or delayed in updating our COVID vaccine to protect against future variants of the SARS-CoV-2 virus. 🔒

🟡 Modified We have entered into strategic alliances with third parties for product development and commercialization. If these alliances are unsuccessful, our business could be adversely affected. 🔒

🟡 Modified We may seek to establish additional strategic alliances and, if we are unable to do so on commercially reasonable terms, we may have to alter our development and commercialization plans. Certain of our strategic alliance agreements may restrict our ability to develop certain products. 🔒

🟡 Modified Our success depends on our ability to retain key employees, consultants and advisors and to attract, retain and motivate qualified personnel. 🔒

🟡 Modified Because we are developing some of our product candidates for the treatment of diseases in which there is little clinical experience and, in some cases, using new endpoints or methodologies, the FDA or other regulators may not consider the endpoints of our clinical trials to provide clinically meaningful results. 🔒

🟡 Modified We are subject, directly or indirectly, to federal and state healthcare fraud and abuse laws and false claims laws. If we cannot comply, or have not fully complied, with such laws, we could face substantial penalties. 🔒

🟡 Modified Our products are, and any future products will be, subject to regulatory scrutiny. 🔒

🟡 Modified There are risks unique to each of our programs and modalities and risks applicable across programs and modalities, which may delay or prevent our ability to advance one or more of our programs in clinical development, obtain regulatory approval or commercialize our products. 🔒

🟡 Modified The commercial success of our products depends on the degree of market acceptance by physicians, patients, third-party payors and others in the medical community. 🔒

🟡 Modified We have experienced commercial challenges and may experience additional challenges in the future. 🔒

🟡 Modified Preclinical development is lengthy and uncertain, especially for mRNA medicines. 🔒

🟡 Modified Changes in tax law could adversely affect our business and financial condition. 🔒

🟡 Modified Our manufacturing facilities or those of third-party manufacturers or suppliers may fail to meet regulatory requirements, which could delay approval of or increase production costs for our products. 🔒

🟡 Modified We are subject to various and evolving laws and regulations governing the privacy and security of personal data, and our failure to comply could result in fines or criminal penalties and damage our reputation. 🔒

🟡 Modified We may experience delays in enrolling participants in our clinical trials. 🔒

🟡 Modified The vaccine market, and pharmaceutical market more generally, is intensely competitive, and we may be unable to compete effectively in the market for existing or new products, treatment methods or technologies. 🔒

🟡 Modified We incurred net losses in 2025 and 2024, and expect to incur additional losses in the future; we may not achieve long-term sustainable profitability. 🔒

🟡 Modified mRNA drug development involves substantial clinical and regulatory risks, and negative perceptions of our platform, products and product candidates could adversely affect our business and ability to obtain regulatory approvals. 🔒

🟡 Modified Our intismeran autogene product candidates are uniquely manufactured for each patient using a novel, complex manufacturing process and we may encounter difficulties in production. 🔒

🟡 Modified Our use of generative AI ("GenAI") and other AI technologies presents certain risks and challenges given the emerging nature of AI technologies. 🔒

🟡 Modified As we grow as a commercial company and our drug development pipeline matures, the increased demand for clinical and commercial supplies from our facilities and third parties may impact our ability to operate. 🔒

🟡 Modified Evolving environmental, social and governance (ESG) standards and expectations may expose us to numerous risks. 🔒

🟡 Modified We do not expect to pay cash dividends for the foreseeable future. 🔒

🟡 Modified We may encounter difficulties in managing changes to the size, structure and scope of our company. 🔒

31 more changes in this filing

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