Amgen (NASDAQ:AMGN) executives highlighted broad-based growth in 2025 and laid out expectations for continued momentum in 2026, while also detailing pipeline priorities, portfolio decisions, and a regulatory dialogue related to Tavneos during the company’s fourth-quarter earnings call.
2025 results: broad portfolio strength and multiple growth brands
Chief Executive Officer Bob Bradway said Amgen delivered “strong operational performance across the board” in 2025, pointing to 14 products reaching blockbuster status, 13 products posting double-digit sales growth, and 18 products achieving record results. The company reported double-digit growth in revenues and earnings per share for the year, supported by what Bradway described as the “breadth” of the portfolio.
Commercial highlights: Repatha, Evenity, rare disease, oncology, and biosimilars
Repatha sales grew 36% year-over-year in 2025 and surpassed $3 billion, Gordon said. He and Chief Scientific Officer Jay Bradner also discussed new outcomes data from the phase 3 VISSCELIA-CV trial, presented at the American Heart Association and published in The New England Journal of Medicine. Bradner said the study enrolled more than 12,000 patients without a prior heart attack or stroke and showed a 25% relative risk reduction in a composite endpoint (including coronary heart disease death, heart attack, or ischemic stroke), along with a 36% reduction in heart attack, with no new safety signals.
Gordon said Amgen believes the data create an opportunity to update clinical guidelines and quality measures, and he described continued work to expand access in the U.S., including broad formulary coverage and the launch of a direct-to-patient cash-pay option through “Amgen Now.” Management also referenced plans to expand the program to additional medicines.
Evenity sales increased 34% in 2025 to $2.1 billion, Gordon said, with U.S. sales up 41% on higher volumes. He said Evenity leads the bone builder segment with more than 60% market share, and that approximately 300,000 U.S. patients have been treated to date.
In rare disease, Gordon said the portfolio grew 14% year-over-year to nearly $5.2 billion. Uplizna sales rose 73% to $655 million, reflecting demand across three approved indications. Bradner highlighted two 2025 approvals: European Commission approval for IgG4-related disease and FDA approval in December for generalized myasthenia gravis in certain antibody-positive adults. In Q&A, Gordon said early GMG uptake has included roughly half bio-naïve patients and half switching from other therapies, and management noted the convenience of twice-yearly dosing.
In oncology, management said the innovative oncology portfolio grew 11% year-over-year to $8.7 billion in 2025. Imdelltra generated $627 million in full-year sales, with Gordon citing rapid adoption and more than 1,600 U.S. sites administering the therapy, primarily in community settings. Bradner noted the FDA granted full approval in November for extensive-stage small cell lung cancer after progression on or after platinum-based chemotherapy. The company also said it is advancing Imdelltra in frontline extensive-stage disease in combination therapy and in a phase 3 study for limited-stage small cell lung cancer.
Amgen’s biosimilars business posted 37% sales growth to $3 billion in 2025, Gordon said, while Bradway noted the company’s biosimilar portfolio has contributed more than $13 billion in sales since 2018. Gordon said Pavblu, a biosimilar to Eylea, reached $700 million in 2025. In Q&A, he said Amgen has established “good inroads” with large retina specialist networks and believes its device and biosimilar experience position it to compete as additional entrants arrive, though the company did not provide product-level guidance.
R&D pipeline: MariTide, Olpasiran, Tezspire expansion, and immunology updates
Bradner described 2025 as a year of “disciplined execution” across R&D, including five key regulatory approvals. A central focus was MariTide, which executives repeatedly framed as potentially differentiated by less frequent dosing. Bradner said both phase 3 chronic weight management studies are fully enrolled, while ASCVD and heart failure outcomes studies are progressing. He added that Amgen has begun enrollment of two phase 3 sleep apnea studies and now has six global phase 3 studies underway for MariTide.
Bradner said Amgen completed part 2 of a phase 2 chronic weight management study and the first 24 weeks of a phase 2 type 2 diabetes study enrolling participants with and without obesity. He said results from both increased the company’s confidence in MariTide’s potential and its “monthly or less frequent dosing” opportunity. In Q&A, management said the design details of phase 3 studies in type 2 diabetes, including control arms, will be discussed in a future engagement.
On Olpasiran, Bradner said the fully enrolled OCEANA outcomes study is progressing, but the endpoint accrual rate remains lower than initial predictions. He said the company will update the timeline for primary analysis as appropriate, while reiterating confidence in the program based on genetic and epidemiologic evidence.
Bradner also discussed Tezspire’s ongoing phase 3 studies in chronic obstructive pulmonary disease and eosinophilic esophagitis, with study completion expected in the second half of 2026. Separately, he announced positive phase 2 data for Daxdilimab in primary discoid lupus erythematosus, stating the trial met primary and key secondary endpoints with an “attractive safety profile,” and said Amgen is working to advance the program.
Portfolio decisions and FDA dialogue on Tavneos
Executives described several “portfolio decisions” to reallocate resources. Bradner said Amgen terminated its rocatinlimab development and commercialization collaboration with Kyowa Kirin, and that the program will return to Kyowa Kirin, which will assume full ownership. He also said Amgen decided not to pursue regulatory approval for bemarituzumab in first-line gastric cancer following previously announced results from FORTITUDE-101 and FORTITUDE-102, though management observed an “emerging signal” of potential survival benefit in a biomarker-defined subset and expects to share findings with the scientific community in the future.
Bradner said the company is in an “ongoing dialogue” with the FDA regarding Tavneos for ANCA-associated vasculitis. In Q&A, he said the FDA requested a voluntary withdrawal on Jan. 16 and that Amgen was “surprised” by the request, which he said related to concerns about a process used by ChemoCentryx to readjudicate primary endpoint results for nine of 331 patients in the ADVOCATE phase 3 study. He said the company will provide updates as discussions progress.
Financial performance and 2026 outlook
Chief Financial Officer Peter Griffith reported a 2025 non-GAAP operating margin of 46% and said non-GAAP R&D spending increased 22% year-over-year to a record $7.2 billion, reflecting investment in multiple late-stage opportunities and approximately $300 million in incremental R&D spending from business development transactions in the second half of the year. Griffith said Amgen generated $8.1 billion in free cash flow and retired $6 billion of debt in 2025. Capital expenditures were $2.2 billion.
For 2026, Griffith guided to total revenues of $37.0 billion to $38.4 billion and non-GAAP EPS of $21.60 to $23. He said the outlook assumes continued strength from six growth drivers—Repatha, Evenity, Tezspire, rare disease, innovative oncology, and biosimilars—offsetting anticipated declines from denosumab biosimilar competition, certain price declines, and increased 340B utilization.
Griffith also flagged several modeling considerations for early 2026, including seasonal first-quarter headwinds tied to the U.S. insurance cycle, lower first-quarter sales patterns for Otezla and Enbrel, and additional impact from denosumab biosimilar competition in Q1. He noted roughly $250 million of inventory build in the fourth quarter of 2025 that “could potentially impact first quarter sales,” and said the company expects lower mid-single-digit year-over-year growth in Q1 revenue.
The company forecast a full-year non-GAAP operating margin of roughly 45% to 46% (as a percentage of product sales), non-GAAP R&D expense growth in the low single digits excluding the 2025 business development impact, and non-GAAP other income and expense of about $2.3 billion to $2.4 billion. Griffith guided to a non-GAAP tax rate of 16% to 17.5%, share repurchases not to exceed $3 billion, and 2026 capital expenditures of about $2.6 billion as Amgen prepares manufacturing capacity for potential MariTide launch.
About Amgen (NASDAQ:AMGN)
Amgen Inc (NASDAQ: AMGN) is a global biotechnology company founded in 1980 and headquartered in Thousand Oaks, California. The company focuses on discovering, developing, manufacturing and delivering human therapeutics that address serious illnesses. Amgen’s work centers on biologic medicines derived from cellular and molecular biology, with an emphasis on translating advances in human genetics and protein science into therapies for patients.
Amgen’s commercial portfolio has historically included biologics used in oncology, supportive care, nephrology, bone health and cardiovascular disease.
