Moderna

New or substantially reworded (8)

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

• 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. Read more

  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…

• We may experience difficulties executing our near-term strategy and prioritized pipeline.

• 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.

• On May 12, 2025, President Trump issued an executive order calling on pharmaceutical manufacturers to voluntarily reduce the prices of medicines in the U.S. Read more

  and directing the Secretary of Health and Human Services (HHS) to communicate price targets to pharmaceutical manufacturers to align prices with those in comparably developed nations, an approach commonly referred to as "most-favored-nation" (MFN) pricing and, in the event significant progress towards MFN pricing is not delivered, to propose rulemaking to impose MFN pricing.

• MFN pricing models in the U.S. could also affect our international pricing strategy and future decisions on reimbursement and commercialization in certain jurisdictions. Read more

  If our U.S. pricing becomes tied to international reference prices, we may face decisions regarding pricing in foreign markets that could result in reduced patient access internationally, affect our relationships with foreign regulatory authorities and payers, or impact our ability to obtain or maintain reimbursement approvals in ex-U.S. markets.

• These reforms remain subject to change, potential legal challenges, or expansion through additional rulemaking or sub‑regulatory guidance, creating uncertainty for our overall pricing strategy. Read more

  It remains to be seen whether and how these drug pricing initiatives will apply to our products, how they will affect the broader pharmaceutical industry, and whether similar reform measures may be adopted in the future.

• For example, recent FDA policy updates regarding COVID vaccine approvals and the evidence expected for certain populations could require additional clinical data or trials to support broader indications, delay approvals or supplemental applications, or result in more limited labeled populations, which could adversely affect the timing and scope of commercialization for our COVID vaccines, including updated or variant-adapted formulations.

No longer in the text (4)

• 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.

• There is significant uncertainty around the amount of future revenue we will recognize from sales of our COVID vaccine—which is our primary source of revenue—as well as sales of RSV and other respiratory vaccines. Read more

  Accurately forecasting vaccination rates for our products, which directly impacts overall market size, has been difficult, and these difficulties may persist. Vaccination rates in the future may also be lower than our expectations, and are likely to be impacted by a number of factors, including public health authority recommendations, medical need, viral evolution and consumer motivation to vaccinate. Additionally, the recent Presidential election in the U.S. may impact policies and priorities related to our industry.

• In 2024, we recognized $3.1 billion of product sales, compared to $6.7 billion, $18.4 billion and $17.7 billion in 2023, 2022 and 2021, respectively. Read more

  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 vaccines , in 2024, the overall RSV vaccine market was smaller than anticipated, in part due to recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP) regarding the frequency of vaccination and recommendations related to who, in terms of age or risk factors, should receive an RSV vaccine. These recommendations were more limited than anticipated and future advisory committee recommendations (including with respect to RSV re-vaccination and age group recommendations) may…

• We may be unsuccessful in executing our cost efficiency and portfolio prioritization efforts.