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Amgen Inc.: Q3 FY2026 earnings call

What management said about Q3 FY2026, from the documents filed with the SEC on 3 November 2026: press release. Guidance figures: 3 raised, 4 kept. The quarter’s numbers.

Key takeaways

  • Revenue rose 8% to $10.4 billion: Total revenues were $10.4 billion, with product sales up 8% on volume growth. Seventeen products grew at least double digits in the quarter. Source
  • Full-year guidance raised: Management raised full-year 2026 revenue, GAAP EPS and non-GAAP EPS ranges. Capital expenditure, share repurchase and tax rate guidance were kept. Source
  • Non-GAAP EPS rose 14%: Non-GAAP EPS was $6.45 against $5.64. Higher revenues were partly offset by higher operating expenses, and non-GAAP operating margin was 47.3%. Source
  • Newer medicines drove volume growth: UPLIZNA sales rose 191% to $451 million and IMDELLTRA rose 128% to $406 million, both primarily on volume. Repatha, EVENITY and TEZSPIRE grew 37%, 39% and 43%. Source
  • Prolia and XGEVA sales fell: Prolia sales fell 45% to $632 million, with 23% lower volume. XGEVA sales fell 47% to $288 million. Both cited multiple biosimilars launched globally. Source
  • GAAP margin rose on lower amortization: GAAP operating margin rose 9.9 points to 37.5% of product sales. Cost of sales fell on lower amortization of acquisition-related assets and lower manufacturing costs. Source
  • TAVNEOS withdrawal request ongoing: The FDA's Center for Drug Evaluation and Research requested voluntary withdrawal of TAVNEOS. The company requested a hearing on June 1, 2026 and sent supporting materials on July 23, 2026. Source
  • Free cash flow fell to $3.7 billion: Free cash flow was $3.7 billion against $4.2 billion, on operating cash flow of $4.2 billion. The prior-year quarter benefited from rebate and collection timing. Source

“The strength of our commercial portfolio, combined with important clinical advances and a promising late-stage pipeline, reinforces our confidence in Amgen’s ability to deliver durable growth well into the next decade.”

Robert A. Bradway, chairman and chief executive officer

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues Sourcefull year 2026$38.9 billion to $39.7 billionRaised from $38.2 billion to $39.4 billion
GAAP diluted EPS Sourcefull year 2026$18.34 to $19.28Raised from $15.80 to $17.08
GAAP tax rate Sourcefull year 202614.5% to 16.0%Kept
Non-GAAP diluted EPS Sourcefull year 2026$22.90 to $23.70Raised from $22.30 to $23.50
Non-GAAP tax rate Sourcefull year 202615.0% to 16.5%Kept
Capital expenditures Sourcefull year 2026approximately $2.6 billionKept
Share repurchases Sourcefull year 2026not to exceed $3.0 billionKept
Acquisition-related expenses per share (EPS reconciliation) Sourcefull year 20265.99 to 6.13
Net gains from equity investments (EPS reconciliation) Sourcefull year 2026(1.70) per share

What changed from last quarter

  • Guidance raised: Full-year 2026 total revenue guidance was raised to $38.9 billion to $39.7 billion. Source
  • Guidance raised: Full-year 2026 GAAP EPS guidance was raised to $18.34 to $19.28. Source
  • Guidance raised: Full-year 2026 non-GAAP EPS guidance was raised to $22.90 to $23.70. Source
  • Guidance kept: Capital expenditures guidance of approximately $2.6 billion and the share repurchase cap of $3.0 billion were both kept. Source
  • New: Phase 3 OASIZ-301 results for dazodalibep in Sjögren's disease were announced in October, after the second quarter release. Source
  • New: The biosimilar BLA for ABP 206 against OPDIVO was submitted and accepted for FDA review in this quarter. Source
  • New: The FDA approved an update to the IMDELLTRA Prescribing Information shortening the monitoring time for the first two doses. Source

Results and growth drivers

  • Revenue rose 8% to $10.4 billion: Total revenues were $10.4 billion, with product sales up 8% on volume growth. Seventeen products grew at least double digits in the quarter. Source
  • Full-year guidance raised: Management raised full-year 2026 revenue, GAAP EPS and non-GAAP EPS ranges. Capital expenditure, share repurchase and tax rate guidance were kept. Source
  • Non-GAAP EPS rose 14%: Non-GAAP EPS was $6.45 against $5.64. Higher revenues were partly offset by higher operating expenses, and non-GAAP operating margin was 47.3%. Source
  • GAAP EPS rose 19%: GAAP diluted EPS was $7.08 against $5.93. GAAP operating income was $3.7 billion against $2.5 billion, and GAAP operating margin was 37.5%. Source
  • Seventeen products annualize above $1 billion: The count of products annualizing above $1 billion was seventeen, the same as in the second quarter release. Source

Products and regions

  • Newer medicines drove volume growth: UPLIZNA sales rose 191% to $451 million and IMDELLTRA rose 128% to $406 million, both primarily on volume. Repatha, EVENITY and TEZSPIRE grew 37%, 39% and 43%. Source
  • Prolia and XGEVA sales fell: Prolia sales fell 45% to $632 million, with 23% lower volume. XGEVA sales fell 47% to $288 million. Both cited multiple biosimilars launched globally. Source
  • Enbrel sales rose on sales deductions: Enbrel sales rose 5% to $611 million, helped by favorable sales deductions. Net selling price fell 14%, reflecting Medicare Part D price setting effective in 2026. Source
  • Otezla and TAVNEOS sales declined: Otezla sales fell 18% to $481 million on 13% lower volume. TAVNEOS sales fell 2% to $105 million, with 8% unfavorable sales deductions. Source
  • Established products grew on price: Aranesp, Neulasta and Parsabiv together had $606 million of sales. Net selling price rose 19%, partly offset by 3% lower volume. Source
  • U.S. carried most product sales: U.S. product sales were $7,259 million and ROW sales were $2,624 million, within total product sales of $9,883 million. Source

“We continue to engage with the U.S. Food and Drug Administration (FDA) and believe that TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile.”

Amgen Inc., press release

Costs, margins and tax

  • GAAP margin rose on lower amortization: GAAP operating margin rose 9.9 points to 37.5% of product sales. Cost of sales fell on lower amortization of acquisition-related assets and lower manufacturing costs. Source
  • Non-GAAP cost of sales rose 15%: Non-GAAP cost of sales was $1,907 million, or 19.3% of product sales, on higher profit share expense and sales mix, partly offset by lower manufacturing costs. Source
  • R&D spend rose 11%: GAAP R&D expenses were $2,111 million, up 11%, driven by Research and Early Pipeline spend, including business development. Source
  • SG&A and tax rates fell: GAAP SG&A fell 2% to $1,680 million. The GAAP tax rate fell 0.5 points to 17.5%, and the non-GAAP tax rate fell 2.3 points to 15.9%. Source

Pipeline and clinical data

  • MariTide Phase 3 program grew: MARITIME-T2D-3 started enrolling, and MARITIME-CV, MARITIME-OSA-1 and MARITIME-OSA-2 completed enrollment. Two more T2D Phase 3 studies start in Q4 2026. Source
  • Repatha cardiovascular data presented: New VESALIUS-CV analyses at ESC showed a 27% relative reduction in 3-P MACE and a nominal 21% reduction in cardiovascular death. Source
  • Dazodalibep improved Sjögren's activity: In the Phase 3 OASIZ-301 study, dazodalibep showed a 1.8-point placebo-adjusted improvement in systemic disease activity at Week 48 with every-four-week dosing. Source
  • TEZSPIRE eosinophilic esophagitis data: In CROSSING, TEZSPIRE every four weeks reached histologic remission at Week 24 in 64.8% and 68.9% of patients, versus 3.5% on placebo. Source
  • IMDELLTRA first-line survival benefit: In DeLLphi-305, adding IMDELLTRA to durvalumab in first-line maintenance gave a 58% reduction in risk of death. The results were published in the New England Journal of Medicine. Source
  • TEPEZZA Japan study met endpoints: The Phase 3 Chronic-J study of TEPEZZA in Japanese patients with chronic thyroid eye disease met both primary endpoints, with a consistent safety profile. Source

Regulatory matters

  • TAVNEOS withdrawal request ongoing: The FDA's Center for Drug Evaluation and Research requested voluntary withdrawal of TAVNEOS. The company requested a hearing on June 1, 2026 and sent supporting materials on July 23, 2026. Source
  • Blinatumomab studies on hold: Two subcutaneous blinatumomab studies remain on partial clinical hold by the FDA. Management says discussions are underway on a path to reopen them. Source
  • ABP 206 biosimilar BLA accepted: The BLA for ABP 206 against OPDIVO was submitted and accepted. ABP 234 results against KEYTRUDA were submitted for FDA file acceptance. Source
  • Otezla pediatric safety study complete: The Phase 3 pediatric Otezla safety study, in patients aged six through 17 with mild to moderate plaque psoriasis, is complete. Results will be submitted to the FDA. Source

Cash, balance sheet and capital returns

  • Free cash flow fell to $3.7 billion: Free cash flow was $3.7 billion against $4.2 billion, on operating cash flow of $4.2 billion. The prior-year quarter benefited from rebate and collection timing. Source
  • Dividend rose 6% to $2.52: The third quarter dividend was $2.52 per share, paid September 11, 2026 to holders of record as of August 21, 2026. Source
  • No share repurchases in quarter: No shares were repurchased in the quarter. Dividends paid were $1.4 billion and capital expenditures were $0.6 billion. Source
  • Cash rose, debt fell: Cash and cash equivalents were $13.2 billion and debt outstanding was $54.0 billion at September 30, 2026, against $9.1 billion and $54.6 billion at December 31, 2025. Source

Strategy and leadership

  • CEO sees durable growth ahead: Chairman and CEO Robert A. Bradway said the commercial portfolio, clinical advances and late-stage pipeline reinforce confidence in durable growth into the next decade. Source
  • Sunakiment asthma Phase 3 planned: Research and Early Pipeline spend rose, including business development. The company is planning a Phase 3 asthma program for sunakiment with AstraZeneca. Source
  • Daxdilimab moving toward Phase 3: Daxdilimab showed CLASI-A improvements in a Phase 2 study in primary discoid lupus erythematosus. The company is taking steps to advance it to Phase 3. Source

Coming up, as management said on 3 November 2026

  • MariTide T2D studies start in Q4: Two additional Phase 3 MariTide studies in people with T2D are scheduled to be initiated in the fourth quarter of 2026. Source
  • OASIZ 303 completion expected Q4: The Phase 3 OASIZ 303 study of dazodalibep is expected to complete in the fourth quarter of 2026. Source
  • Full dazodalibep data at ACR: Full OASIZ-301 results will be presented as a late-breaking oral presentation at the ACR Convergence meeting in November. Source
  • FDA action on ABP 206 by year-end: Management expects an FDA action on the ABP 206 biosimilar BLA by the end of 2026. Source
  • UPLIZNA CIDP Phase 3 start: A Phase 3 study of UPLIZNA in CIDP is to be initiated between the second half of 2026 and the first half of 2027. Source

Figures management reported

FigureReported
Repatha sales Source$1,085 million, up 37%
Prolia sales Source$632 million, down 45%
XGEVA sales Source$288 million, down 47%
Enbrel sales Source$611 million, up 5%
Otezla sales Source$481 million, down 18%
TEZSPIRE sales Source$538 million, up 43%
R&D expense (GAAP) Source$2,111 million, up 11%
Biosimilar products within Other products Source$258 million in Q3 ’26, $151 million in Q3 ’25
Regulatory approval: IMDELLTRA monitoring update SourceFDA approved in September 2026
Trial readout: DeLLphi-305 overall survival Source58% reduction in risk of death
Trial readout: Chronic-J (TEPEZZA, Japan) SourceBoth primary endpoints met

Risks management discussed

  • Regulatory: The FDA has asked for voluntary withdrawal of TAVNEOS from the U.S. market, and that request remains under discussion. Source
  • Regulatory: Two subcutaneous blinatumomab studies remain on partial clinical hold, with enrollment paused. Source
  • Demand: Biosimilar competition reduced XGEVA volume and net selling price, as with Prolia. Source

Earlier plans management reported on

  • Not stated: The second quarter plan called for three T2D Phase 3 starts in 2026. The third quarter release reports one started and two more planned for Q4 2026.
  • Not stated: The second quarter release expected both studies to complete in H2 2026. The third quarter release reports OASIZ-301 results and expects OASIZ 303 to complete in Q4 2026.
  • Not stated: The company said in the second quarter it was planning a Phase 3 asthma program, and it repeats that plan this quarter.

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.