AMGEN INC (AMGN) Risk Factors

Recent key developments

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

• The IRA enables the U.S. government to set prices for certain drugs in Medicare, including ENBREL effective January 1, 2026, and Otezla effective January 2027, at significantly lower levels, and imposes inflation penalties.January 1, 2026
• On July 4, 2025, OB3 was enacted and included changes to Medicare, Medicaid and Affordable Care Act policies expected to adversely affect coverage and reimbursement for our products.July 4, 2025
• On May 12, 2025, the Administration issued the MFN Prescription Drug Pricing Executive Order to set U.S. pricing targets using price benchmarks from other developed countries.May 12, 2025
• On July 31, 2025, the Administration sent the July MFN Letter to many pharmaceutical manufacturers, including Amgen, outlining steps to advance actions consistent with the MFN EO.July 31, 2025
• In December 2025, Amgen announced actions satisfying the components of the July MFN Letter, including the Administration’s MFN pricing requests.December 2025
• On April 15, 2025, an executive order directed HHS to align treatment of small molecule drugs and biologics in Medicare price setting under the IRA.April 15, 2025
• In April 2024, CMS finalized policy changes giving Part D plans more flexibility to substitute biosimilars for innovator products on formularies in 2025.April 2024
• CMS announced the GENEROUS Model under which we and other manufacturers will provide additional supplemental rebates to state Medicaid programs to align net prices with prices in select other countries.
• Colorado PDAB deemed ENBREL unaffordable and established an Upper Payment Limit (UPL) for ENBREL effective no earlier than January 1, 2027, with annual review; the UPL is subject to ongoing litigation.January 1, 2027
• Washington state's PDAB selected ENBREL for an affordability review on July 16, 2025, and may not establish a UPL before January 1, 2027.July 16, 2025
• New York established a Medicaid drug spending cap and Massachusetts implemented a new review and supplemental rebate negotiation process for Medicaid patients.
• Twenty-two states have enacted laws with mandates on manufacturers in the 340B Program, typically restricting manufacturers' ability to direct drugs in 340B channels and requiring recognition of 340B contract pharmacies.
• In Genesis Health Care, Inc. v. Becerra, a district court enjoined HRSA from enforcing a more restrictive patient definition under the 340B Program, which could affect 340B discount eligibility if adopted broadly.
• The FDA authorized Colorado's drug importation program in June 2026, and Florida's importation program was authorized in 2024, potentially impacting small molecule products.June 2026
• Proposals in the EU general pharmaceutical legislation review could reduce the duration of regulatory data exclusivity and orphan drug exclusivity protections, with full implementation not expected before 2027.
• In July 2024, an IT outage from a faulty software update by a cybersecurity firm temporarily affected our systems.July 2024
• We disclosed a cybersecurity incident under Item 1.05 of our Current Report on Form 8-K filed on July 31, 2026, involving threat actors accessing data stored in cloud-hosted environments.July 31, 2026
• In two separate incidents, most recently in 2025, individuals used fraudulent identification in connection with their hiring by the Company.2025
• In November 2025, a third-party service provider had a cybersecurity incident where Amgen-related information was accessed and disclosed by a threat actor.November 2025
• Change Healthcare experienced a ransomware attack in 2024 that disrupted co-pay card support, insurance billing, and Medicaid rebate processing.2024
• LUMAKRAS approved under FDA accelerated approval, with full approval conditioned on confirmatory study following a Complete Response Letter and new postmarketing requirement.
• TAVNEOS: On January 16, 2026, FDA requested voluntary market withdrawal; on March 31, 2026, FDA issued a DSC on serious liver injury; on April 29, 2026, CBE-30 supplement updated U.S. label; on April 27, 2026, CDER proposed withdrawal; on April 30, 2026, Federal Register notice gave hearing opportunity; on June 1, 2026, hearing requested; July 23, 2026 submission of real world evidence and independent re-adjudication of ADVOCATE data.January 16, 2026
• EVENITY approved April 2019 with a postmarketing requirement for a five-year observational feasibility study potentially followed by a comparative safety study or trial due to cardiovascular serious adverse event imbalance.April 2019
• In June 2026, we initiated recalls of certain lots of KYPROLIS distributed in Türkiye and certain lots of Corlanor and Sensipar distributed in the United States.June 2026
• Legislative proposal would have prohibited the U.S. Department of Veterans Affairs from purchasing certain drugs that have active pharmaceutical ingredients manufactured outside the United States.