Moderna, Inc. (MRNA) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that Moderna, Inc. surfaced in its latest filing.

• In 2025, changes at U.S. regulatory agencies impacted policies and priorities related to our industry.2025
• Advisory committee recommendations for RSV were more limited than anticipated.
• We have been excluded from selling our COVID vaccines in many European markets due to a competitor’s contract with the European Commission, which does not lapse until year-end 2026.2026
• President Trump issued an executive order on May 12, 2025 calling for voluntary price reductions and directing HHS to communicate price targets to align U.S. prices with comparably developed nations via MFN pricing, and to propose rulemaking to impose MFN pricing if significant progress is not made.2025-05-12
• To date, we have only received regulatory approvals for our COVID and RSV vaccines.
• U.S. Supreme Court's June 2024 Loper Bright decision overturning Chevron deference may result in additional legal challenges to FDA regulations and guidance.2024-06
• Rare pediatric disease designation obtained for mRNA-3927.
• Priority review voucher eligibility may be lost if FDA determines criteria are no longer met, designation is revoked, or approval does not occur by September 30, 2029.2029-09-30
• Recalls of certain batches of our COVID vaccine shipped to Japan in 2021 that were found to contain foreign particulate.2021
• Net losses of $2.8 billion in 2025.2025
• Net losses of $3.6 billion in 2024.2024
• Incurred net losses in each year since inception except 2022 and 2021.
• As of December 31, 2025, we had approximately $8.1 billion in cash, cash equivalents and investments, including a $600 million draw down from our term loan facility.2025-12-31
• We have experienced significant growth in operations and workforce in recent years and have undertaken initiatives to reduce costs, prioritize our portfolio and adjust organizational size and structure.
• In October 2020, the FDA published a final rule allowing importation of certain prescription drugs from Canada.2020-10
• In January 2024, the FDA approved Florida's request to import certain lower-priced medications from Canada.2024-01
• The Inflation Reduction Act of 2022 includes drug pricing controls and Medicare redesign that have begun implementation.2022
• In May 2025, the President issued an executive order to reduce U.S. drug prices to match the lowest price in comparably developed nations.2025-05
• Department of Justice January 8, 2025, rule on Preventing Access to U.S. Sensitive Personal Data and Government-Related Data by Countries of Concern or Covered Persons.2025-01-08
• The Clinical Trials Regulation (EU) No. 536/2014 and the EMA policy on publication of clinical data for medicinal products for human use provide for publication of certain clinical information from MAAs.
• Trump Administration executive order on Ensuring a National Policy Framework for Artificial Intelligence endorsed a federal moratorium on enforcement of state AI laws.
• In 2024, class action and derivative litigations were filed against us related to statements made about our RSV vaccine.2024
• As of February 13, 2026, executive officers, directors and affiliated shareholders owned approximately 8% of outstanding common stock, and non-affiliated 5% or greater shareholders owned approximately 32%.2026-02-13