Amgen Inc Earnings - Q4 2025 Analysis & Highlights
Amgen delivered strong operational performance in 2025 with double-digit revenue and earnings growth, driven by blockbuster products including Repatha, EVENITY, and TEZSPIRE, while advancing a robust pipeline with significant late-stage programs in obesity, cardiovascular disease, and rare diseases, positioning the company for sustained growth through 2026 and beyond.
Key Financial Results
Full year 2025 revenues grew at double-digit rates with 10% sales growth delivered.
Non-GAAP operating margin reached 46% for the full year.
14 products achieved blockbuster status with sales of $1 billion or more.
13 products delivered double-digit sales growth.
18 products achieved record results.
Non-GAAP R&D spending increased 22% year-over-year to a record $7.2 billion.
Full year non-GAAP other income and expense was $2.1 billion.
Free cash flow generated was $8.1 billion for the full year.
Capital expenditures totaled $2.2 billion in 2025.
Business Segment Results
General Medicine segment: Repatha sales grew 36% year-over-year, surpassing $3 billion.
General Medicine segment: EVENITY sales increased 34% in 2025, reaching $2.1 billion.
General Medicine segment: Prolia delivered $4.4 billion in sales, an increase of 1% year-over-year.
Rare Disease portfolio grew 14% year-over-year to nearly $5.2 billion.
Rare Disease portfolio grew 19% in the quarter.
UPLIZNA sales increased 73% year-over-year to $655 million.
TEPEZZA grew 3% to $1.9 billion in 2025.
TAVNEOS sales were $459 million in 2025, an increase of 62% year-over-year.
Inflammation segment: TEZSPIRE sales grew 52% year-over-year to nearly $1.5 billion.
Otezla sales increased 7% year-over-year to nearly $2.3 billion.
Innovative Oncology portfolio grew 11% year-over-year, generating $8.7 billion in full year sales.
IMDELLTRA delivered $627 million in full year sales.
BLINCYTO grew 28% year-over-year to over $1.5 billion in full year sales.
Biosimilar portfolio delivered sales increasing 37% to $3 billion.
PAVBLU reached $700 million in sales in 2025.
Capital Allocation
Dividend payments of $2.38 per share in the fourth quarter, representing a 6% increase compared to 2024.
$6 billion of debt retired in 2025.
Share repurchases not to exceed $3 billion in 2026.
Capital expenditures of about $2.6 billion expected in 2026.
Capital expenditures reflect significant investments across the United States, including Ohio, North Carolina, Puerto Rico, Rhode Island, and California.
Industry Trends and Dynamics
More than 100 million people around the world still need effective LDL cholesterol lowering.
Nearly 90% of the 2 million women at very high risk of fracture remain untreated.
Dissatisfaction with weekly GLP-1 therapies is evident in the market.
Rapid uptake of oral semaglutide demonstrates patient and prescriber preference for alternative dosing options.
Sjögren's syndrome has been very challenging for drug development.
ANCA-associated vasculitis is a serious, potentially life-threatening disease with limited therapeutic options.
Competitive Landscape
Repatha remains the first and only PCSK9 inhibitor with outcomes data for patients in both high-risk primary and secondary prevention.
Repatha is the most evidence-backed therapy in the PCSK9 class.
EVENITY leads the bone builder segment with over 60% market share.
EVENITY is now growing faster than the category overall.
UPLIZNA leads in NMOSD and remains the most prescribed FDA-approved therapy in the US for this condition.
TEZSPIRE is now the leading therapy for new-to-brand patients amongst allergists in severe uncontrolled asthma.
IMDELLTRA has become the standard of care in the second-line setting for small cell lung cancer.
BLINCYTO is widely recognized as the standard of care in combination with multi-agent chemotherapy for patients with Philadelphia chromosome-negative B-cell ALL.
Amgen is an industry leader in biosimilars.
Biosimilars portfolio has contributed more than $13 billion in sales since the launch of the first medicine in 2018.
Multiple biosimilars have launched globally for denosumab, creating increased competition for Prolia.
Merck's oral PCSK9 inhibitor represents potential competition for Repatha.
Macroeconomic Environment
Consistent with historical trends tied to the annual United States health insurance cycle, a seasonal headwind to sales is expected in Q1 2026 driven by benefit plan changes, insurance re-verifications, and higher patient co-pay obligations.
Increased 340B Program utilization is anticipated to impact sales.
Growth Opportunities and Strategies
MariTide is positioned as a differentiated treatment for obesity, Type 2 diabetes, and obesity-related conditions.
MariTide stands alone as the only therapy in late-stage development to offer monthly, every other month, or even quarterly dosing.
Six global Phase 3 studies are underway with MariTide, collectively designed to deliver a comprehensive evidence base.
Both Phase 3 chronic weight management studies for MariTide are fully enrolled.
ASCVD and heart failure outcomes studies for MariTide are progressing well.
Two Phase 3 sleep apnea studies for MariTide are beginning enrollment.
MariTide has the potential to expand what's possible for patients with monthly or less frequent dosing.
Olpasiran is positioned as a potentially best-in-class small interfering RNA medicine targeting Lp(a).
OCEAN(a)-Outcomes study for Olpasiran continues to progress as an event-driven study.
Repatha, Olpasiran, and MariTide together will represent a compelling set of cardiometabolic medicines.
UPLIZNA approvals in IgG4-related disease and generalized myasthenia gravis in 2025 exemplify growth opportunity.
UPLIZNA is being advanced for autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy.
Dazodalibep, a CD40 ligand-targeting biotherapeutic, has both Phase 3 studies in Sjögren's disease fully enrolled.
Daxdilimab, a first-in-class plasmacytoid dendritic cell depleting monoclonal antibody, showed positive Phase 2 data in primary discoid lupus erythematosus.
TEZSPIRE Phase 3 program continues with ongoing studies in chronic obstructive pulmonary disease and eosinophilic esophagitis.
IMDELLTRA is being advanced as combination therapy in frontline extensive stage small cell lung cancer.
IMDELLTRA is advancing with an ongoing Phase 3 study of limited stage small cell lung cancer.
Xaluritamig continues to advance through Phase 3 development in prostate cancer.
Xaluritamig has initiated a Phase 1b study in relapsed or refractory Ewing sarcoma.
ABP 206 and ABP 234 biosimilar candidates have completed enrollment in comparative clinical studies.
Amgen is leveraging AI across the value chain to accelerate therapeutic discovery and late-stage development.
AmgenNow, a direct-to-patient program, offers a simplified, lower cost cash pay option for patients to access Repatha.
Amgen is making therapies available through TrumpRx to help improve affordability for Americans.
TEPEZZA is planned for launch in additional markets in 2026.
Repatha's VESALIUS-CV trial data support updating clinical guidelines and quality measures.
Pipeline and Research & Development
2026 will be a year of disciplined data generation from Phase 2 and Phase 3 programs.
Fourth quarter delivered five key regulatory approvals.
FDA granted full approval to IMDELLTRA for extensive stage small cell lung cancer.
European Commission approved UPLIZNA for IgG4-related disease.
FDA approved UPLIZNA for generalized myasthenia gravis.
Rocatinlimab development and commercialization collaboration with Kyowa Kirin was terminated.
Bemarituzumab regulatory approval will not be pursued in first-line gastric cancer.
TAVNEOS is subject to ongoing dialogue with the FDA regarding the medicine for ANCA-associated vasculitis.
AMG 513, an internal clinical stage asset, is progressing in Phase 1 clinical investigation.
Pre-clinical programs include incretin-based and non-incretin-based medicines, both injectable and oral.
Financial Guidance and Outlook
2026 total revenues expected in the range of $37.0 billion to $38.4 billion.
Non-GAAP earnings per share between $21.60 to $23 expected for 2026.
Revenue range reflects continuing strong performance from six key growth drivers: Repatha, EVENITY, TEZSPIRE, Rare Disease, innovative Oncology, and Biosimilars portfolios.
Expected growth in 2026 to more than offset anticipated declines from increased denosumab biosimilar competition.
Expected growth to offset price declines for certain other products in 2026.
Expected growth to offset continued increases in 340B Program utilization.
Lower mid-single digit year-over-year growth expected in the first quarter of 2026.
Other revenue expected in the range of $1.6 billion to $1.8 billion for the full year.
Full year non-GAAP operating margin as a percentage of product sales projected to be roughly 45% to 46%.
Non-GAAP R&D expense expected to grow low-single digits, excluding business development transactions.
Q1 non-GAAP operating margin expected to be the lowest of the year and roughly the same as Q4 of 2025.
Non-GAAP other income and expense anticipated to be about $2.3 billion to $2.4 billion in 2026.
Non-GAAP tax rate expected to be 16% to 17.5%.
Approximately $250 million of inventory build in Q4 2025 could potentially impact first quarter sales.
Otezla and Enbrel expected to follow historical pattern of lower sales in the first quarter.
Additional impact from denosumab biosimilar competition expected in Q1.
Prolia expected to experience accelerated sales erosion in 2026 driven by increased biosimilar competition.
Otezla expected to experience sales erosion driven by unfavorable pricing in the US and generic launches in the EU.
Regulatory and Compliance
TAVNEOS voluntary withdrawal was requested by the FDA on January 16.
FDA concerns were raised about a process followed by ChemoCentryx to re-adjudicate primary endpoint results for 9 of 331 patients.
Amgen is in discussions with FDA regarding TAVNEOS.
TEPEZZA has an ongoing subcutaneous Phase 3 clinical study in moderate-to-severe active TED, fully enrolled, with completion expected in the second half of 2026.
