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Amgen Inc.: Q1 FY2026 earnings call

What management said about Q1 FY2026, from the documents filed with the SEC on 30 April 2026: press release. Guidance figures: 3 raised, 2 lowered, 2 kept. The quarter’s numbers.

Key takeaways

  • Revenue grew 6% on product volume: Total revenues rose 6% to $8.6 billion. Product sales grew 4%, driven by 9% volume growth, partly offset by 2% lower net selling price and 2% lower inventory levels. Source
  • Sixteen products grew double digits: Sixteen products delivered at least double-digit sales growth; seventeen products are annualizing above $1 billion based on first quarter sales. Source
  • Enbrel net price hit by Medicare: Enbrel sales fell 37% to $320 million. The lower net selling price reflects Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026, and higher 340B Program mix. Source
  • FDA proposes TAVNEOS withdrawal: On April 27, 2026, the FDA's drug center proposed withdrawing TAVNEOS approval, citing new information on lack of substantial evidence of effectiveness and untrue statements in the application. Source
  • TAVNEOS stays on market during review: The FDA's statement says TAVNEOS will remain on the market during the review process. ChemoCentryx may request a hearing on the proposal. Source
  • Free cash flow reached $1.5 billion: Free cash flow was $1.5 billion versus $1.0 billion a year earlier, driven by business performance and working capital timing, partly offset by higher capital expenditures. Source

“Our first quarter results demonstrate the strength of our business, with 16 brands achieving double-digit growth, enabling us to grow through expected patent expirations and increased competition.”

Robert A. Bradway, chairman and chief executive officer

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues SourceFull year 2026$37.1 billion to $38.5 billionRaised from $37.0 billion to $38.4 billion
GAAP diluted EPS SourceFull year 2026$15.62 to $17.10Raised from $15.45 to $16.94
GAAP tax rate SourceFull year 202614.5% to 16.0%Lowered from 15.5% to 17.0%
Non-GAAP diluted EPS SourceFull year 2026$21.70 to $23.10Raised from $21.60 to $23.00
Non-GAAP tax rate SourceFull year 202615.0% to 16.5%Lowered from 16.0% to 17.5%
Capital expenditures SourceFull year 2026approximately $2.6 billionKept
Share repurchases SourceFull year 2026not to exceed $3.0 billionKept
Acquisition-related expenses per share (GAAP to non-GAAP EPS reconciliation) SourceFull year 20266.02 to 6.10

What changed from last quarter

  • Guidance raised: Full-year 2026 total revenue range raised. Source
  • Guidance raised: Full-year 2026 GAAP and non-GAAP EPS ranges raised. Source
  • Guidance lowered: Full-year 2026 GAAP and non-GAAP tax rate ranges lowered. Source
  • Guidance kept: Capital expenditures and share repurchase limits kept at prior levels. Source
  • New: FDA proposal to withdraw TAVNEOS approval, dated April 27, 2026. Source
  • New: China conditional approval for IMDELLTRA in third-line extensive stage SCLC. Source
  • New: Positive Phase 3 topline results for subcutaneous TEPEZZA via on-body injector. Source
  • New: European Commission approval of UPLIZNA for generalized myasthenia gravis. Source
  • New: Company taking steps to advance daxdilimab to a registrational phase. Source
  • Ended: Development of AMG 193 discontinued, with listed studies ended. Source
  • Ended: AMG 329 Phase 2 Sjögren's study stopped after meeting futility criteria. Source

Results and growth drivers

  • Revenue grew 6% on product volume: Total revenues rose 6% to $8.6 billion. Product sales grew 4%, driven by 9% volume growth, partly offset by 2% lower net selling price and 2% lower inventory levels. Source
  • Sixteen products grew double digits: Sixteen products delivered at least double-digit sales growth; seventeen products are annualizing above $1 billion based on first quarter sales. Source
  • GAAP EPS rose 4% to $3.34: GAAP diluted EPS rose from $3.20 to $3.34, with higher operating income partly offset by net unrealized losses on equity investments. Source
  • Non-GAAP EPS rose 5% to $5.15: Non-GAAP EPS rose from $4.90 to $5.15 on higher revenues, partly offset by higher operating expenses. Source

Product sales by brand

  • Repatha sales up 34%: Repatha sales reached $876 million, with 35% volume growth and 8% favorable changes to estimated sales deductions, partly offset by 7% lower net selling price. Source
  • Tezspire and Uplizna both up: UPLIZNA sales rose 188% to $262 million, primarily on volume growth. TEZSPIRE sales rose 20% to $343 million, driven by 32% volume growth. Source
  • Imdelltra sales more than tripled: IMDELLTRA sales rose 219% to $258 million, driven by volume growth, with IMDYLLTRA alongside it under the same line. Source
  • Tepezza sales up 29%: TEPEZZA sales rose to $490 million, with a 22% impact from higher inventory levels and higher net selling price. Source
  • Prolia sales fell 34%: Prolia sales fell to $727 million, driven by 17% lower volume and 10% lower net selling price, with 4% from lower inventory levels. Source
  • Nplate growth excluding government order: Nplate sales rose 32% to $412 million. Excluding a $60 million U.S. government order, sales rose 12%, on 8% volume growth and higher net selling price. Source

“With a new wave of molecules progressing in Phase 3 clinical development, we're confident in our ability to deliver”

Robert A. Bradway, chairman and chief executive officer

Pricing and net selling price

  • Enbrel net price hit by Medicare: Enbrel sales fell 37% to $320 million. The lower net selling price reflects Medicare Part D price setting under the Inflation Reduction Act, effective January 1, 2026, and higher 340B Program mix. Source
  • Amjevita price up 18%: AMJEVITA sales rose 27% to $173 million, primarily driven by 18% higher net selling price and an 8% favorable foreign exchange impact. Source
  • Established products sales rose 1%: Established products sales were $563 million. Higher net selling price of 10% was partly offset by 4% lower volume and 4% unfavorable changes to estimated sales deductions. Source

Costs and margins

  • Cost of sales ratio fell: GAAP cost of sales fell to 33.4% of product sales from 37.7%. Lower acquisition-related amortization drove the decline; higher profit share and royalty expense partly offset it. Source
  • R&D spend up 16% on MariTide: R&D expenses rose 16%, driven by higher spend in later-stage clinical programs, including MariTide. GAAP R&D was 20.9% of product sales. Source
  • Non-GAAP operating margin 45.3%: Non-GAAP operating margin as a share of product sales was 45.3%, down 0.4 points. GAAP operating margin rose 17.4 points to 32.4%. Source
  • SG&A down, tax rate lower: Non-GAAP SG&A fell 4% on lower general and administrative expenses, partly offset by commercial costs. Non-GAAP tax rate fell 1.0 point to 13.6%. Source

Pipeline and trial updates

  • MARITIME-SWITCH study initiated: A new MariTide Phase 3 study enrolls adults switching from weekly tirzepatide or semaglutide to MariTide on an every eight-week or quarterly schedule. Source
  • Repatha subgroup shows 31% reduction: In a subgroup of 3,655 high-risk diabetes patients without known significant atherosclerosis, Repatha reduced 3-P MACE risk by 31% and heart attack risk by 31%. Source
  • TEPEZZA on-body injector met primary endpoint: Subcutaneous TEPEZZA via on-body injector matched IV efficacy, with a 77% proptosis response at week 24 versus 19.6% for placebo. Source
  • Olpasiran CCTA plaque study started: The OCEAN(a)-CCTA study, a Phase 3 coronary artery plaque trial, was initiated and enrolls patients with atherosclerotic disease and elevated Lp(a). Source
  • Xaluritamig Phase 3 studies enrolling: XALute, a Phase 3 study of xaluritamig, is enrolling patients with metastatic castration-resistant prostate cancer who have had prior taxane-based chemotherapy. Source
  • Blinatumomab lupus study stopped enrolling: The Phase 2 blinatumomab study in systemic lupus erythematosus, with and without nephritis, has stopped enrollment, and the Company is determining next steps. Source

TAVNEOS regulatory action

  • FDA proposes TAVNEOS withdrawal: On April 27, 2026, the FDA's drug center proposed withdrawing TAVNEOS approval, citing new information on lack of substantial evidence of effectiveness and untrue statements in the application. Source
  • TAVNEOS stays on market during review: The FDA's statement says TAVNEOS will remain on the market during the review process. ChemoCentryx may request a hearing on the proposal. Source
  • Company will contest withdrawal: The Company intends to engage with the FDA, believes TAVNEOS shows effectiveness and a favorable benefit - risk profile, and will follow the appropriate process. Source
  • CBE-30 label change filed: A CBE-30 supplement, submitted April 29, 2026, amends the hepatotoxicity warning to add information on post-marketing vanishing bile duct syndrome cases, including fatal outcomes. Source
  • Liver injury cases reported since 2021: Vanishing bile duct syndrome cases have been reported since the 2021 approval, largely from Japan, with fatal outcomes in some patients and none from the United States. Source

Cash and capital returns

  • Free cash flow reached $1.5 billion: Free cash flow was $1.5 billion versus $1.0 billion a year earlier, driven by business performance and working capital timing, partly offset by higher capital expenditures. Source
  • No share repurchases in quarter: No shares were repurchased under the stock repurchase program during the first quarter of 2026. Source
  • Dividend of $2.52 per share: The first quarter 2026 dividend of $2.52 per share was paid March 6, 2026, a 6% increase on the same period in 2025. Source
  • Cash and debt both higher: Cash and cash equivalents were $12.0 billion and debt outstanding $57.3 billion at March 31, 2026, up from $9.1 billion and $54.6 billion at year-end. Source

Coming up, as management said on 30 April 2026

  • Repatha subgroup at European course in May: Further VESALIUS-CV analysis in patients with prior percutaneous coronary intervention will be presented at the European Course in May. Source
  • Diabetes subgroup at ADA in June: Further VESALIUS-CV analysis in high-risk diabetes patients will be presented at the American Diabetes Association Scientific Sessions in June. Source
  • Three MariTide diabetes studies start: Three Phase 3 MariTide studies in people with type 2 diabetes will be initiated during 2026. Source
  • UPLIZNA Phase 3 studies start H2: Phase 3 UPLIZNA studies in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy will begin in the second half of 2026. Source
  • Dazodalibep Sjögren's studies complete H2: Completion of both Phase 3 dazodalibep studies in Sjögren's disease is expected in the second half of 2026. Source
  • TEZSPIRE esophagitis study completes H2: The Phase 3 TEZSPIRE study in eosinophilic esophagitis is expected to complete in the second half of 2026. Source
  • TEPEZZA full data at congress: Full results from the on-body injector study will be presented at an upcoming medical congress. Source

Figures management reported

FigureReported
Total product sales Source$8,218 million
Research and development expense (GAAP) Source$1,719 million
Repatha sales Source$876 million
TEZSPIRE sales Source$343 million
Prolia sales Source$727 million
Enbrel sales Source$320 million
UPLIZNA sales Source$262 million
IMDELLTRA sales Source$258 million
Biosimilars sales Source$185 million
Phase 3 proptosis response (TEPEZZA on-body injector) Source77% at week 24
Regulatory approval (IMDELLTRA, China) SourceConditional approval, third-line ES-SCLC
Regulatory action (TAVNEOS) SourceFDA proposal to withdraw approval

Risks management discussed

  • Regulatory: If no hearing is granted, the FDA may enter summary judgment and ultimately withdraw TAVNEOS approval. Source
  • Regulatory: Liver injury is a known TAVNEOS risk, and the topic has been under ongoing dialogue with the FDA. Source
  • Demand: Prolia and XGEVA sales erosion is expected to accelerate in 2026 as multiple biosimilars have launched globally. Source
  • Operational: A Phase 1b IMDELLTRA combination study has paused enrollment in extensive-stage small cell lung cancer. Source

Earlier plans management reported on

  • Not stated: Study completion timing for the AMG 104 asthma Phase 2 is given as H1 2026. Source
  • Not stated: The Company's plan to start UPLIZNA Phase 3 studies is now dated to H2 2026. Source
  • Not stated: Positive topline results were announced in April for the subcutaneous TEPEZZA Phase 3 study, which had a completion expectation of H2 2026. Source
  • Not stated: The Company states it remains committed to patient safety, needs and support in the TAVNEOS matter. 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.