BRISTOL MYERS SQUIBB CO (BMY) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that BRISTOL MYERS SQUIBB CO surfaced in its latest filing.

• In August 2024, HHS announced a maximum fair price for a 30-day supply of Eliquis effective January 1, 2026 in the Medicare channel.August 2024
• In November 2025, HHS announced a maximum fair price for a 30-day supply of Pomalyst effective January 1, 2027 in the Medicare channel.November 2025
• In January 2026, HHS selected Orencia for government-set prices beginning in 2028.January 2026
• In December 2025, BMS entered a U.S. Government Agreement to provide Eliquis free to Medicaid effective January 1, 2026.December 2025
• The U.S. Government Agreement commits BMS to donate over seven tons of Eliquis API to the U.S. Strategic Active Ingredient Reserve.
• The U.S. Government Agreement provides BMS U.S. tariff relief until January 2029, but such relief may be terminated or not extended.
• In July 2025, the OBBBA was enacted, aiming for healthcare spending efficiencies in Medicaid.July 2025
• Effective July 1, 2024, BMS generally recognizes up to four 340B contract pharmacy locations per hospital lacking an entity-owned pharmacy.July 1, 2024
• The American Rescue Plan Act of 2021 eliminated the Medicaid Prescription Drug Rebate cap as of January 1, 2024.January 1, 2024
• Generic manufacturers have begun marketing generic versions of Eliquis in certain EU countries while legal proceedings are pending and may seek to market in other EU countries prior to patent and SPC expiration.
• Following adverse judicial decisions in the UK and Finland, generic manufacturers have begun marketing generic versions of Eliquis in these countries and may seek to market in additional countries in Europe prior to patent expiration.
• As a result of patent settlements, generic entry for Revlimid in the UK began on January 18, 2022, and in various other European countries on February 18, 2022.January 18, 2022
• In the U.S., following patent settlements, certain companies have begun marketing generic lenalidomide pursuant to licenses, which as of January 31, 2026, are no longer volume-limited.January 31, 2026
• In October 2025, the FDA issued new draft guidance to streamline and accelerate biosimilar development, including minimizing the requirement for comparative clinical efficacy studies.October 2025
• In November 2023, the FDA announced an investigation into the risk of T-cell malignancies in patients treated with CAR-T cell therapy.November 2023
• In January 2024, the FDA required safety labeling changes for approved CAR-T cell therapies, including a boxed warning about T-cell malignancy risk.January 2024
• Royalties related to Keytruda are expected to terminate on December 31, 2026.December 31, 2026
• Royalties related to Tecentriq are expected to terminate on December 31, 2026.December 31, 2026
• Royalties related to the divestiture of the diabetes business terminated on December 31, 2025.December 31, 2025
• Standard & Poor's downgraded BMS's long-term credit rating from A+ to A following the December 2023 acquisition announcements.December 2023