Amgen 8-K

EarningsNew guidanceImpairment / chargeDeal terminated

FDA sought voluntary U.S. withdrawal of TAVNEOS over trial re-adjudication and liver toxicity concerns; Amgen declined.

Filed 2026-02-03 16:03 ET

Summary

Q4 and FY2025 results with FY2026 guidance. Revenue rose 9% Y/Y in Q4 and 10% for the year; GAAP diluted EPS increased in both periods, while non-GAAP diluted EPS was nearly flat in Q4 and rose for FY2025. Amgen issued FY2026 revenue, EPS, tax-rate, capital expenditure and share repurchase outlook. The FDA requested voluntary U.S. withdrawal of TAVNEOS over concerns about re-adjudication of trial results for 9 of 331 participants and hepatotoxicity; Amgen declined and is evaluating next steps with the FDA, leaving the product’s U.S. status unresolved.

Key Figures

Metric Q4 2025 Q4 2024 Y/Y
Total revenue $9.87B $9.09B 9%
Operating income, GAAP $2.72B $2.31B 18%
Operating income, non-GAAP $4.01B $4.03B -0.7%
Net income, GAAP $1.33B $0.627B 113%
Net income, non-GAAP $2.88B $2.88B 0%
Diluted EPS, GAAP $2.45 $1.16 111%
Diluted EPS, non-GAAP $5.29 $5.31 -0.4%
Operating cash flow $1.60B $4.77B -66%
Free cash flow $0.961B $4.40B -78%
Metric FY2025 FY2024 Y/Y
Total revenue $36.8B $33.4B 10%
Operating income, GAAP $9.08B $7.26B 25%
Operating income, non-GAAP $16.2B $15.0B 7.8%
Net income, GAAP $7.71B $4.09B 88%
Net income, non-GAAP $11.8B $10.7B 10%
Diluted EPS, GAAP $14.23 $7.56 88%
Diluted EPS, non-GAAP $21.84 $19.84 10%
Operating cash flow $9.96B $11.5B -13%
Free cash flow $8.1B $10.4B -22%
  • Product sales grew 7% in Q4, driven by 10% volume growth partly offset by 4% lower net selling price; FY product sales rose 10%, on 13% volume growth partly offset by a 3% price decline. FY GAAP EPS reflected higher revenue and BeOne equity investment gains, partly offset by higher operating expenses, including a $1.2B Otezla intangible asset impairment after its selection for Medicare price setting.
  • Lower free cash flow reflected working-capital timing, primarily collections, and higher capital expenditures; Q4 was also affected by tax-payment timing. At 12/31/2025, cash was $9.1B and debt outstanding was $54.6B; Amgen retired $6.0B of debt during 2025, and debt leverage was 3.2x EBITDA.
  • No shares were repurchased in 2025, vs $0.2B in 2024; average diluted shares were 543M vs 542M in Q4 and 542M vs 541M for FY. The Q4 dividend was $2.38/share, up 6% Y/Y. Amgen plans to end its rocatinlimab collaboration with Kyowa Kirin, subject to Hart-Scott-Rodino review; Kyowa Kirin will assume the program and Amgen will provide transition services.

Guidance

Metric Period Guidance Prior Direction
Total revenue FY2026 $37.0B-$38.4B — —
Diluted EPS, GAAP FY2026 $15.45-$16.94 — —
Tax rate, GAAP FY2026 15.5%-17% — —
Diluted EPS, non-GAAP FY2026 $21.60-$23.00 — —
Tax rate, non-GAAP FY2026 16%-17.5% — —
Capital expenditures FY2026 ≈$2.6B — —
Share repurchases FY2026 Not to exceed $3B — —

Investor Takeaways

  • FY2026 revenue and EPS against the outlook will show whether growth offsets expected competitive and pricing pressure; Amgen expects accelerated Prolia and XGEVA erosion from biosimilars and lower Enbrel sales.
  • Watch for the FDA’s next steps on TAVNEOS, which will determine the path forward for its U.S. market status.
  • Amgen expects to initiate MariTide Phase 3 studies in people with type 2 diabetes in 2026; progress in those studies and ongoing chronic weight-management trials will be key pipeline milestones.

The summary is written by an AI model reading the filing.

Model 005 · prompt 01d34d48e3

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