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Amgen Inc.: Q4 FY2025 earnings call

What management said about Q4 FY2025, from the documents filed with the SEC on 3 February 2026: press release. Guidance figures: 8 new. The quarter’s numbers.

Key takeaways

  • Full-year revenue rose 10%: Total revenues reached $36.8 billion for 2025, up 10%. Product sales rose 10% on 13% volume growth, partly offset by 3% lower net selling price. Source
  • GAAP EPS rose on equity investment gains: GAAP diluted EPS rose 88% to $14.23 for 2025, helped by unrealized gains on the BeOne equity stake and partly offset by higher operating expenses and the Otezla impairment. Source
  • Non-GAAP EPS rose 10% for the year: Non-GAAP diluted EPS rose 10% to $21.84 for 2025 from $19.84. Fourth-quarter non-GAAP EPS was $5.29, against $5.31 a year earlier. Source
  • Non-GAAP margin fell on profit share: Non-GAAP operating margin on product sales fell 3.5 points to 42.8% in the fourth quarter and 0.8 points to 46.1% for 2025, on higher profit share expense and sales mix. Source
  • Free cash flow fell to $8.1 billion: Free cash flow was $8.1 billion for 2025, down from $10.4 billion, on working capital timing, mainly collections, and higher capital expenditures. Fourth-quarter free cash flow was $1.0 billion. Source
  • MariTide second-year data reported: Part 2 of the Phase 2 MariTide obesity study showed most participants kept weight loss for another 52 weeks on lower doses, with no new safety issues observed. Source
  • TAVNEOS withdrawal request from FDA: FDA asked ChemoCentryx on January 16, 2026 to voluntarily withdraw TAVNEOS, citing re-adjudication of endpoints for 9 of 331 trial patients. Amgen is reviewing next steps with FDA. Source

“We enter 2026 with momentum across a broad portfolio of medicines and a clear path towards advancing innovative therapies to deliver sustained long-term growth”

Robert A. Bradway, chairman and chief executive officer

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues SourceFull year 2026$37.0 billion to $38.4 billionNew
GAAP diluted EPS SourceFull year 2026$15.45 to $16.94New
GAAP tax rate SourceFull year 202615.5% to 17.0%New
Non-GAAP diluted EPS SourceFull year 2026$21.60 to $23.00New
Non-GAAP tax rate SourceFull year 202616.0% to 17.5%New
Capital expenditures SourceFull year 2026approximately $2.6 billionNew
Share repurchases SourceFull year 2026not to exceed $3 billionNew
Repatha net selling price SourceFull year 2026decline by roughly mid single-digitsNew

What changed from last quarter

  • New guidance: Full-year 2026 guidance issued for revenues, GAAP and non-GAAP EPS, tax rates, capital expenditures and share repurchases. Source
  • Ended: Rocatinlimab development and commercialization collaboration with Kyowa Kirin to be terminated, subject to Hart-Scott-Rodino review. Source
  • Ended: Bemarituzumab will not be pursued for regulatory approval in first-line gastric cancer, based on the FORTITUDE-101 and FORTITUDE-102 studies. Source
  • New: Amgen told the FDA on January 28, 2026 that it would not withdraw TAVNEOS from the US market, and is evaluating next steps with the agency. Source
  • New: FDA granted full approval for IMDELLTRA in adults with ES-SCLC whose disease progressed on or after platinum-based chemotherapy. Source
  • New: FDA approved UPLIZNA for generalized myasthenia gravis in adults who are antibody positive for AChR or MuSK. Source

Full-year and fourth-quarter results

  • Full-year revenue rose 10%: Total revenues reached $36.8 billion for 2025, up 10%. Product sales rose 10% on 13% volume growth, partly offset by 3% lower net selling price. Source
  • Fourth-quarter revenue rose 9%: Fourth-quarter total revenues were $9.9 billion, up 9%. Product sales rose 7% on 10% volume growth, partly offset by 4% lower net selling price. Source
  • Record and billion-dollar product counts: Eighteen products set full-year sales records, fourteen passed $1 billion in annual sales, and thirteen grew at least double digits in 2025. Source
  • GAAP EPS rose on equity investment gains: GAAP diluted EPS rose 88% to $14.23 for 2025, helped by unrealized gains on the BeOne equity stake and partly offset by higher operating expenses and the Otezla impairment. Source
  • Non-GAAP EPS rose 10% for the year: Non-GAAP diluted EPS rose 10% to $21.84 for 2025 from $19.84. Fourth-quarter non-GAAP EPS was $5.29, against $5.31 a year earlier. Source

Franchise and product sales

  • Repatha and EVENITY sales grew: Repatha full-year sales rose 36% to $3.0 billion and EVENITY rose 34% to $2.1 billion, both mainly on volume. Fourth-quarter Repatha sales were $870 million, up 44%. Source
  • Prolia sales fell in fourth quarter: Prolia sales fell 10% to $1.1 billion in the fourth quarter on 8% lower net selling price and lower volume. Full-year Prolia sales rose 1%. Source
  • TEZSPIRE volume drove growth: TEZSPIRE sales rose 60% to $474 million in the fourth quarter and 52% for the year, mainly on volume. TEPEZZA sales were $457 million, down 1% in the quarter. Source
  • Ultra-rare sales eroded on generics: Ultra-Rare products fell 27% in the fourth quarter to $157 million and 5% for the year, mainly from generic competition for RAVICTI. Source
  • IMDELLTRA sales rose sequentially: IMDELLTRA sales were $234 million in the fourth quarter and $627 million for the year. Quarter-on-quarter growth was 31%, driven by volume. Source
  • Otezla flat in fourth quarter: Otezla sales were flat at $625 million in the fourth quarter and rose 7% for the year. PAVBLU sales were $258 million in the fourth quarter and $700 million for the year. Source

“Amgen is evaluating next steps with the FDA to determine a path forward, while keeping patient safety, needs, and support at the forefront.”

Amgen Inc., press release

Costs, margins and tax

  • GAAP cost of sales fell on amortization: GAAP cost of sales fell to 31.8% of product sales in the fourth quarter from 35.7%, mainly on lower amortization of acquired assets, including Horizon inventory, and lower manufacturing costs. Source
  • Non-GAAP margin fell on profit share: Non-GAAP operating margin on product sales fell 3.5 points to 42.8% in the fourth quarter and 0.8 points to 46.1% for 2025, on higher profit share expense and sales mix. Source
  • R&D rose on later-stage MariTide spend: R&D expense rose 24% in the fourth quarter, mainly on later-stage programs including MariTide and early pipeline work, which included business development in the quarter. Source
  • GAAP operating margin rose for year: GAAP operating income rose to $9.1 billion for 2025 from $7.3 billion. GAAP operating margin rose 3.1 points to 25.8%, after the Otezla impairment charges. Source
  • Otezla impairment tied to IRA: The company recorded $1.2 billion of Otezla intangible asset impairment charges in 2025 after Otezla was selected for Medicare price setting under the Inflation Reduction Act. Source
  • GAAP tax rate rose for year: GAAP tax rate rose 2.8 points to 14.1% for 2025, on earnings mix including equity gains. The fourth-quarter GAAP rate fell 7.8 points to 12.0%. Source

Capital, cash and shareholder returns

  • Free cash flow fell to $8.1 billion: Free cash flow was $8.1 billion for 2025, down from $10.4 billion, on working capital timing, mainly collections, and higher capital expenditures. Fourth-quarter free cash flow was $1.0 billion. Source
  • Dividend up 6%, no buybacks: The fourth-quarter dividend was $2.38 per share, a 6% increase on the prior year. No shares were repurchased in the fourth quarter or in full-year 2025. Source
  • Debt retired and leverage near 3.2 times: The company retired $6.0 billion of debt in 2025, ending with $54.6 billion of debt and $9.1 billion of cash. Debt leverage was about 3.2 times EBITDA. Source
  • Operating cash flow declined: Operating cash flow was $10.0 billion for 2025 against $11.5 billion, and $1.6 billion in the fourth quarter against $4.8 billion a year earlier. Source

“Amgen is confident that TAVNEOS demonstrates effectiveness and a favorable benefit - risk profile.”

Amgen Inc., press release

Pipeline and clinical milestones

  • MariTide second-year data reported: Part 2 of the Phase 2 MariTide obesity study showed most participants kept weight loss for another 52 weeks on lower doses, with no new safety issues observed. Source
  • MariTide diabetes study results: A Phase 2 MariTide study in type 2 diabetes reported reductions in HbA1c and weight at 24 weeks, with mostly mild to moderate GI side effects. Source
  • VESALIUS-CV full results published: Full VESALIUS-CV results for Repatha were presented at AHA and published in NEJM. The trial showed a 25% relative reduction in 3-point MACE and 36% lower heart attack risk. Source
  • Daxdilimab met lupus Phase 2 endpoint: A Phase 2 study of daxdilimab in discoid lupus met its primary endpoint at week 24 at both doses, with acceptable safety. A 12-patient dermatomyositis study was too small to assess efficacy. Source

Regulatory and label events

  • TAVNEOS withdrawal request from FDA: FDA asked ChemoCentryx on January 16, 2026 to voluntarily withdraw TAVNEOS, citing re-adjudication of endpoints for 9 of 331 trial patients. Amgen is reviewing next steps with FDA. Source
  • UPLIZNA approved in EU for IgG4-RD: The European Commission approved UPLIZNA in November 2025 for adults with active IgG4-related disease. Source
  • TAVNEOS pediatric study enrolling: A Phase 3 open-label TAVNEOS study in patients aged 6 to under 18 with ANCA-associated vasculitis is enrolling, using rituximab or a cyclophosphamide regimen. Source
  • IMDELLTRA has several Phase 3 studies: IMDELLTRA has several Phase 3 studies, including DeLLphi-305 in first-line maintenance and DeLLphi-306 following chemoradiation in limited-stage disease. Source

Pricing, biosimilars and seasonality

  • Volume growth offset lower prices: Fourth-quarter product sales rose 7% on 10% volume growth, offset by 4% lower net selling price. For 2025, volume rose 13% and net selling price fell 3%. Source
  • Enbrel sales fell on pricing: Enbrel sales fell 33% for 2025 to $2.2 billion, mainly on 36% lower net selling price from 340B mix, the Medicare Part D redesign and higher commercial discounts. Source
  • Biosimilar sales in other products: Biosimilars within the other-products line were $189 million in the fourth quarter, up from $166 million a year earlier. Source
  • First-quarter dip expected for several products: Management expects Enbrel, Otezla and, to a lesser extent, KRYSTEXXA, TEZSPIRE and Repatha to show lower first-quarter sales, reflecting benefit plan changes and co-pay increases. Source

2026 guidance

  • 2026 revenue range above 2025 range: The 2026 revenue range of $37.0 billion to $38.4 billion compares with the 2025 range of $35.8 billion to $36.6 billion set in the third-quarter release. Source
  • Acquisition adjustments bridge GAAP to non-GAAP: Known acquisition-related adjustments of $6.06 to $6.15 per share bridge 2026 GAAP EPS guidance to the non-GAAP range. Source
  • Known adjustments net of tax: The known adjustments are presented net of their related tax impact, which amounts to approximately $1.01 per share. Source

Coming up, as management said on 3 February 2026

  • MariTide Phase 3 diabetes studies in 2026: Phase 3 studies of MariTide in people living with type 2 diabetes are expected to start in 2026. Source
  • UPLIZNA Phase 3 starts in 2026: Phase 3 studies of UPLIZNA in autoimmune hepatitis and in chronic inflammatory demyelinating polyneuropathy are expected to start in 2026. Source
  • VESALIUS-CV subgroup at March meeting: Analysis of the subgroup without significant atherosclerosis will be presented at the American College of Cardiology in March 2026. Source
  • IMDELLTRA reviews in three regions: Additional regulatory reviews of IMDELLTRA are underway in the European Union, China and Japan. Source
  • Dazodalibep Sjögren's studies complete H2 2026: Completion of both Phase 3 dazodalibep studies in Sjögren's disease is expected in the second half of 2026. Source
  • TEZSPIRE eosinophilic esophagitis study: The Phase 3 TEZSPIRE study in eosinophilic esophagitis is expected to complete in the second half of 2026. Source
  • TEPEZZA subcutaneous study completion: The Phase 3 study of subcutaneous teprotumumab for thyroid eye disease is expected to complete in the second half of 2026. Source
  • AMG 104 asthma study completion: The Phase 2 AMG 104 asthma study is expected to complete in the first half of 2026. Source

Figures management reported

FigureReported
Total product sales, FY2025 Source$35,148 million, up 10%
Repatha sales, Q4 2025 Source$870 million, up 44%
IMDELLTRA sales, FY2025 Source$627 million
TAVNEOS sales, FY2025 Source$459 million, up 62%
GAAP R&D expense, FY2025 Source$7,272 million, up 22%
FDA approvals in the period SourceIMDELLTRA full approval (Nov 2025); UPLIZNA gMG approval (Dec 2025)
Phase 3 VESALIUS-CV result Source25% relative reduction in 3-P MACE
MariTide Phase 3 program SourceSix Phase 3 studies ongoing or enrolling

Risks management discussed

  • Demand: Management expects accelerated sales erosion for Prolia and XGEVA in 2026 as multiple biosimilars have launched globally. Source
  • Demand: Management expects continued RAVICTI sales erosion in 2026 from generic competition. Source
  • Regulatory: FDA raised hepatotoxicity, a known infrequent TAVNEOS risk, in the context of its benefit-risk profile, alongside the endpoint re-adjudication concerns. Source
  • Financial: GAAP results may be affected by impairments, litigation and fair-value changes, because GAAP EPS guidance excludes these events if they occur after the release. Source

Earlier plans management reported on

  • Not stated: The prior release gave a Q4 2025 readout date for Part 2. The fourth-quarter release reports Part 2 as complete, with key findings.
  • Not stated: The prior release planned an AHA presentation on November 8 and journal submission. The fourth-quarter release reports presentation and NEJM publication in November.
  • Not stated: The prior release gave a December 18, 2025 PDUFA date. The fourth-quarter release reports FDA full approval for IMDELLTRA in November.
  • Not stated: The prior release gave a December 14, 2025 PDUFA date for UPLIZNA in generalized myasthenia gravis. The fourth-quarter release reports FDA approval in December.
  • Not stated: The 2025 guidance allowed share repurchases of up to $500 million. The company made no repurchases in the fourth quarter or the full year 2025. Source

Other quarters

Summarised with AI from the documents the company filed with the SEC. Every point is checked against the filing before it is shown: management’s own words word for word, figures against the line or table row they come from. A point that fails the check is left out. Source opens the filing at that line.