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 Inflation Reduction Act mandates Medicare price setting for certain Part B and Part D drugs, starting with 10 drugs effective January 1, 2026, adding 15 in 2027 and 2028, 20 in 2029 and subsequent years, reaching approximately 100 drugs by 2031.
• CMS has set Medicare Part D prices for ENBREL effective January 1, 2026 and Otezla effective January 2027 at significantly lower levels.
• OB3 was enacted on July 4, 2025, with changes to Medicare, Medicaid, and Affordable Care Act policies expected to adversely affect coverage and reimbursement.July 4, 2025
• The Most-Favored-Nation Prescription Drug Pricing Executive Order was issued on May 12, 2025, aiming to use price benchmarks from other developed countries to set U.S. pricing targets.May 12, 2025
• On July 31, 2025, the Administration sent letters 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 that satisfy the components outlined in the July MFN Letter, including the Administration's MFN pricing requests.December 2025
• Colorado's PDAB deemed ENBREL unaffordable and established an Upper Payment Limit substantially lower than its wholesale acquisition cost effective no earlier than January 1, 2027. A preliminary injunction currently blocks implementation, but the matter remains in ongoing litigation.January 1, 2027
• Washington state's PDAB selected ENBREL for an affordability review on July 16, 2025.July 16, 2025
• The FDA authorized Colorado's drug importation program in June 2026.June 2026
• The FDA authorized Florida's importation program in 2024, but the state has not completed significant steps within the two-year authorization window.2024
• Genesis Health Care, Inc. v. Becerra enjoined the Health Resources and Services Administration from enforcing a more restrictive interpretation of who qualifies as a 340B patient, potentially affecting 340B eligibility scope.
• Prior to 2020, reimbursement of Repatha in France was limited to a narrower patient population, such as those with homozygous familial hypercholesterolemia (HoFH), following a national health technology assessment.
• In July 2024, businesses worldwide were affected by an IT outage due to a faulty software update by a cybersecurity firm. The Company's systems and operations were temporarily affected.July 2024
• The company disclosed a cybersecurity incident under Item 1.05 of a Current Report on Form 8-K filed on July 31, 2026.July 31, 2026
• In November 2025, a third-party service provider had a cybersecurity incident in which Amgen-related information was accessed and disclosed.November 2025
• In 2024, Change Healthcare experienced a ransomware attack causing disruptions to healthcare provider and pharmacy operations. Change Healthcare disruptions led to lost sales and required the company to provide extended payment terms to certain customers.2024
• FDA requested voluntary withdrawal of TAVNEOS from the U.S. market on January 16, 2026 based on questions regarding study data supporting original approval.January 16, 2026
• On March 31, 2026, FDA issued a Drug Safety Communication about serious liver injury cases, including fatal DILI, associated with TAVNEOS based on data through October 9, 2024.March 31, 2026
• On April 27, 2026, CDER proposed to withdraw approval of TAVNEOS alleging lack of substantial evidence of effectiveness and untrue statements of material facts in ChemoCentryx's application.April 27, 2026
• On April 29, 2026, Amgen submitted a CBE-30 supplement to FDA, and the U.S. label was updated in May 2026 to include VBDS cases with fatal outcomes.
• Amgen requested a hearing on FDA's withdrawal proposal for TAVNEOS on June 1, 2026 and submitted additional real world evidence on July 23, 2026.June 1, 2026
• LUMAKRAS approved under accelerated approval for KRAS G12C-mutated NSCLC; FDA issued Complete Response Letter after CodeBreaK 200 Phase 3 confirmatory data submission in March 2023.March 2023
• EVENITY approved in April 2019 with postmarketing requirement including five-year observational feasibility study potentially followed by comparative safety study due to cardiovascular serious adverse events imbalance in one phase 3 trial.April 2019
• The CMO producing all KRYSTEXXA drug substance is in Israel, affected by the Middle East conflict including with Iran.
• In June 2026, the company initiated recalls of certain lots of KYPROLIS distributed in Türkiye and Corlanor and Sensipar distributed in the United States.June 2026
• Canada issued a 2024 notice requiring reporting on PFAS manufacture, import, and use.2024