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Amgen Inc.: Q2 FY2026 earnings call

What management said about Q2 FY2026, from the documents filed with the SEC on 4 August 2026: press release. Guidance figures: 2 raised, 4 kept. The quarter’s numbers.

Key takeaways

  • Revenue and product sales rose: Total revenues rose 10% to $10.1 billion. Product sales grew 9%, driven by volume growth, according to the company. Source
  • Six growth drivers grew 26%: Management said six key growth drivers grew 26% year over year and generated nearly 70% of second-quarter product sales. Source
  • Prolia sales fell 32%: Prolia sales fell to $759 million, reflecting 20% lower volume and 12% lower net selling price as biosimilars launched. Source
  • GAAP margin rose on lower amortization: GAAP operating margin rose 6.5 points to 36.8%. GAAP cost of sales fell 4.8 points as a share of product sales, mainly on lower amortization of acquisition-related assets. Source
  • Free cash flow reached $3.5 billion: Free cash flow was $3.5 billion, against $1.9 billion a year earlier. The company cited the absence of the 2025 final repatriation tax payment and business performance. Source
  • Repatha prior-PCI subset results: In the VESALIUS-CV prior-PCI subset of 3,627 patients, 3-P MACE fell 30%, heart attack risk fell 50%, and the heart attack effect appeared as soon as 6 months. Source
  • Subcutaneous blinatumomab studies paused: Two subcutaneous blinatumomab studies paused new enrollment after a partial FDA clinical hold, and discussions with the FDA are under way. Source
  • FDA proposed TAVNEOS withdrawal: The company continues to engage the FDA on CDER's request to voluntarily withdraw TAVNEOS from the U.S. market. Source

“As we expand the potential of our existing medicines through new indications and advance the next wave of pipeline molecules through Phase 3, we remain confident in our ability to deliver growth well into the next decade,”

Robert A. Bradway, chairman and chief executive officer

Guidance

AreaPeriodFigureAgainst last quarter
Total revenues Sourcefull year 2026$38.2 billion to $39.4 billionRaised from $37.1 billion to $38.5 billion
GAAP diluted EPS Sourcefull year 2026$15.80 to $17.08
Non-GAAP diluted EPS Sourcefull year 2026$22.30 to $23.50Raised from $21.70 to $23.10
GAAP tax rate Sourcefull year 202614.5% to 16.0%Kept
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
Known adjustments net of tax, per share Sourcefull year 2026approximately $1.29 per share

What changed from last quarter

  • Guidance raised: Full-year total revenue range raised to $38.2 billion to $39.4 billion from $37.1 billion to $38.5 billion. Source
  • Guidance raised: Full-year non-GAAP EPS range raised to $22.30 to $23.50 from $21.70 to $23.10. Source
  • Guidance kept: Capital expenditure guidance of approximately $2.6 billion and the share repurchase limit of $3.0 billion are both unchanged. Source
  • New: Future development of AMG 513 is to be discontinued. A Phase 1 study in obesity continues to follow enrolled participants. The first quarter listed that study as enrolling. Source
  • New: The company requested an FDA hearing on the proposed TAVNEOS withdrawal on June 1, 2026, and sent supporting materials on July 23, 2026. Source
  • New: IMDELLTRA received full approval in China for second-line ES-SCLC in May, with BeOne to commercialize it there. Source
  • New: Two subcutaneous blinatumomab studies paused new enrollment after a partial FDA clinical hold, which the first quarter did not mention. Source
  • New: The blinatumomab SLE study, which the first quarter reported had stopped enrollment with next steps being determined, is listed as ongoing. Source
  • New: The company is planning a Phase 3 asthma program for sunakiment with AstraZeneca, following the completed LEVANTE study. Source
  • New: Results of a new VESALIUS-CV analysis in high-risk diabetes were presented in June. The first quarter had said this analysis would be presented. Source

Results and growth drivers

  • Revenue and product sales rose: Total revenues rose 10% to $10.1 billion. Product sales grew 9%, driven by volume growth, according to the company. Source
  • Six growth drivers grew 26%: Management said six key growth drivers grew 26% year over year and generated nearly 70% of second-quarter product sales. Source
  • Twenty-two products grew double digits: Twenty-two products delivered at least double-digit sales growth in the quarter. Seventeen products are annualizing at more than $1 billion on second-quarter sales. Source
  • Non-GAAP EPS rose 4%: Non-GAAP diluted EPS rose 4% from $6.02 to $6.29, mainly on higher revenues, partly offset by higher operating expenses and higher income tax expense. Source
  • GAAP EPS rose 65%: GAAP diluted EPS rose from $2.65 to $4.37, which the company attributed to higher revenues. Source

Franchise sales growth

  • Repatha and EVENITY grew: Repatha sales rose 37% to $953 million and EVENITY sales rose 38% to $714 million, both on volume growth. Source
  • UPLIZNA sales rose 90%: UPLIZNA sales rose 90% to $335 million, primarily on volume growth, from $176 million a year earlier. Source
  • TEZSPIRE sales rose 42%: TEZSPIRE sales rose 42% to $486 million, driven by volume growth. Source
  • IMDELLTRA sales more than doubled: IMDELLTRA sales rose 115% to $288 million, primarily on volume growth, from $134 million a year earlier. Source
  • TEPEZZA sales rose 14%: TEPEZZA sales rose 14% to $576 million, reflecting a 6% higher net selling price and 6% volume growth. Source
  • BLINCYTO sales rose 23%: BLINCYTO sales rose 23% to $472 million, with 16% volume growth. Source

“Our six key growth drivers grew 26% year over year, generating nearly 70% of second-quarter product sales.”

Robert A. Bradway, chairman and chief executive officer

Biosimilar and pricing pressure

  • Prolia sales fell 32%: Prolia sales fell to $759 million, reflecting 20% lower volume and 12% lower net selling price as biosimilars launched. Source
  • XGEVA sales fell 34%: XGEVA sales fell 34% to $352 million, with 22% lower volume and 8% lower net selling price, as biosimilars launched. Source
  • Enbrel sales fell 4%: Enbrel sales fell 4% to $580 million, mainly on 22% lower net selling price, partly offset by 16% favorable changes to estimated sales deductions. Source
  • Otezla sales fell 21%: Otezla sales fell 21% to $491 million, primarily on 9% lower net selling price and 6% lower volume. Source
  • MVASI sales fell 20%: MVASI sales fell 20% to $153 million, driven by 16% lower net selling price and lower volume. Source
  • PAVBLU sales rose 121%: PAVBLU sales rose 121% to $287 million, which the company attributed to volume growth as the only commercially available EYLEA biosimilar in the U.S. during this period. Source

Other product sales

  • Established products grew 19%: Aranesp, Neulasta and Parsabiv sales rose 19% to $632 million, on 15% higher net selling price and 2% volume growth. Source
  • Vectibix sales rose 11%: Vectibix sales rose 11% to $338 million, primarily on volume growth. Source
  • Nplate sales rose 17%: Nplate sales rose 17% to $430 million, on 13% volume growth and higher net selling price. Source
  • LUMAKRAS sales rose 23%: LUMAKRAS sales rose 23% to $111 million, primarily on volume growth. Source
  • KYPROLIS sales fell 17%: KYPROLIS sales fell 17% to $314 million, driven by lower volume. Source

“The Company believes that these materials support a favorable benefit-risk profile of TAVNEOS for patients with AAV.”

Amgen Inc., press release

Costs, margins and tax

  • GAAP margin rose on lower amortization: GAAP operating margin rose 6.5 points to 36.8%. GAAP cost of sales fell 4.8 points as a share of product sales, mainly on lower amortization of acquisition-related assets. Source
  • Non-GAAP margin eased 0.5 points: Non-GAAP operating margin fell 0.5 points to 48.4%, as non-GAAP cost of sales rose 1.9 points on higher profit share expense and manufacturing costs. Source
  • R&D rose on MariTide spending: Non-GAAP R&D rose 10% to $1,851 million, driven by Later-Stage Clinical Programs, primarily MariTide, and by Marketed Product Support. Source
  • SG&A and other costs rose: GAAP SG&A rose 3%. Other operating expenses rose to $116 million from $77 million and included litigation expenses. Source
  • Tax rate rose on earnings mix: GAAP tax rate rose 5.5 points to 14.2%, and non-GAAP tax rate rose 1.4 points to 15.6%, the company citing the change in earnings mix. Source

Cash flow and shareholder returns

  • Free cash flow reached $3.5 billion: Free cash flow was $3.5 billion, against $1.9 billion a year earlier. The company cited the absence of the 2025 final repatriation tax payment and business performance. Source
  • Dividend rose 6%: The second-quarter dividend of $2.52 per share was 6% above the same period in 2025. Source
  • No share repurchases in quarter: No shares were repurchased under the program in the second quarter. Dividends paid were $1.4 billion. Source
  • Cash and debt both rose: Cash was $14.0 billion, up from $9.1 billion at year-end. Debt outstanding was $57.3 billion, up from $54.6 billion. Source

Obesity and cardiovascular pipeline

  • Nine MariTide Phase 3 studies: Nine Phase 3 MariTide studies are listed as ongoing or enrolling, including two long-term extension studies for weight-loss maintenance. Source
  • MariTide monthly starting dosing: The company said MariTide's long-acting design supports monthly starting doses and maintenance with as few as 4 or 6 doses a year. Source
  • MariTide liver fat study enrolling: A Phase 2b study on MariTide's effect on liver fat and weight loss is enrolling adults with obesity or overweight and elevated liver fat. Source
  • AMG 513 development discontinued: Future development of AMG 513 is to be discontinued, while its obesity Phase 1 study continues to follow enrolled participants. Source
  • Repatha prior-PCI subset results: In the VESALIUS-CV prior-PCI subset of 3,627 patients, 3-P MACE fell 30%, heart attack risk fell 50%, and the heart attack effect appeared as soon as 6 months. Source
  • Repatha diabetes subgroup results: In a 6,002-patient high-risk diabetes subgroup, 3-P MACE fell 29% and 4-P MACE fell 21%. A nominal 21% decrease in all-cause death was also reported. Source

Oncology and immunology pipeline

  • IMDELLTRA DeLLphi-309 analysis complete: The primary analysis of alternative IMDELLTRA intravenous dosing intervals is complete, and the company will discuss the data with regulators. Source
  • Subcutaneous blinatumomab studies paused: Two subcutaneous blinatumomab studies paused new enrollment after a partial FDA clinical hold, and discussions with the FDA are under way. Source
  • XALute enrollment complete: XALute, the xaluritamig Phase 3 study, completed enrollment in previously taxane-treated prostate cancer. XALience is enrolling chemotherapy-naive patients with abiraterone. Source
  • LEVANTE asthma study complete: The LEVANTE Phase 2 study of sunakiment in asthma is complete. The company said it was informative for dose selection in the planned Phase 3 program. Source
  • Dazodalibep Sjögren's studies underway: Two Phase 3 dazodalibep studies in Sjögren's disease are underway, one in moderate-to-severe systemic activity and one in high symptom burden. Source
  • UPLIZNA IgG4-RD open-label data: Year 1 open-label data in IgG4-related disease were presented at EULAR. The company cited sustained response and disease control with continued UPLIZNA treatment. Source

TAVNEOS regulatory review

  • FDA proposed TAVNEOS withdrawal: The company continues to engage the FDA on CDER's request to voluntarily withdraw TAVNEOS from the U.S. market. Source
  • Hearing requested, materials filed: The company requested a hearing and sent supporting materials to the FDA, which it said support the benefit-risk profile of TAVNEOS for patients with AAV. Source
  • Company view on TAVNEOS: Management said it believes TAVNEOS demonstrates clinical effectiveness and a favorable benefit-risk profile, and it continues to engage the FDA. Source
  • TAVNEOS sales rose 36%: TAVNEOS sales rose 36% to $150 million, driven by volume growth, during the period under the FDA review. Source

Other pipeline updates

  • Golden Gate enrollment complete: Golden Gate, a Phase 3 study of BLINCYTO with low-intensity chemotherapy, completed enrollment of older adults with newly diagnosed B-ALL. Source
  • Daxdilimab moving toward registration: The company is taking steps to advance daxdilimab, a pDC-depleting antibody, to a registrational phase of development. Source
  • TEZSPIRE eosinophilic esophagitis study: A Phase 3 TEZSPIRE study in eosinophilic esophagitis is ongoing, with study completion expected in H2 2026. Source
  • UPLIZNA autoimmune hepatitis study started: The MERCURY Phase 2/3 study of UPLIZNA was initiated in patients with autoimmune hepatitis. Source

Coming up, as management said on 4 August 2026

  • Dazodalibep Sjögren's study completions: Completion of both Phase 3 dazodalibep studies in Sjögren's disease is expected in the second half of 2026. Source
  • VESALIUS-CV data at ESC in August: Three new pre-specified VESALIUS-CV analyses are to be presented as oral abstracts at the ESC Congress in August 2026. Source
  • DeLLphi-309 regulatory discussions: The company will discuss the DeLLphi-309 data with regulators, and detailed results will be presented at an upcoming medical congress. Source
  • Three MariTide diabetes studies in 2026: Three Phase 3 studies of MariTide in people with type 2 diabetes are to be initiated in 2026. Source
  • UPLIZNA CIDP study start window: A Phase 3 UPLIZNA study in CIDP is to start between the second half of 2026 and the first half of 2027. Source

Figures management reported

FigureReported
Repatha sales Source$953 million
EVENITY sales Source$714 million
Prolia sales Source$759 million, down 32%
Biosimilar sales total Source$199 million
IMDELLTRA sales Source$288 million
PAVBLU sales Source$287 million
Biosimilar launches, Prolia and XGEVA SourceMultiple launched globally; more expected
Research and development expense, GAAP Source$1,868 million
IMDYLLTRA EU approval SourceMay 2026

Risks management discussed

  • Demand: Further biosimilar entry is expected for Prolia and XGEVA, and the company tied the declines in those products to biosimilar launches. Source
  • Regulatory: The FDA withdrawal proposal for TAVNEOS remains under review, with the company seeking a hearing. Source
  • Regulatory: Medicare Part D price setting under the Inflation Reduction Act and a higher 340B Program mix reduced Enbrel's net selling price. Source
  • Regulatory: Enrollment in two subcutaneous blinatumomab studies is paused under a partial FDA clinical hold. Source
  • Operational: Higher profit share expense and manufacturing costs increased non-GAAP cost of sales as a share of product sales. Source
  • Financial: Other operating expenses in the quarter included litigation expenses, which the company reported without stating an amount. Source

Earlier plans management reported on

  • Not stated: The first quarter said erosion would accelerate in 2026. The second quarter reports Prolia sales down 32% and XGEVA sales down 34%.
  • Not stated: The first quarter expected completion of the asthma Phase 2 study in H1 2026. The second quarter reports the LEVANTE study as complete.
  • Not stated: The first quarter said TAVNEOS would remain on the market while the withdrawal process proceeds. The second quarter does not restate this.

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.