8-K: Amgen Reports Strong First Quarter 2025 Results Driven by Product Sales Growth

Amgen's first quarter 2025 results show a 9% increase in total revenues, driven by strong product sales and volume growth.

Summary

• Amgen announced its financial results for the first quarter of 2025, reporting a 9% increase in total revenues to $8.1 billion compared to the first quarter of 2024.
• Product sales grew by 11%, primarily driven by a 14% increase in volume, partially offset by a 6% decrease in net selling price.
• U.S. sales increased by 14%.
• Fourteen products experienced double-digit sales growth, including Repatha, BLINCYTO, TEZSPIRE, EVENITY, TAVNEOS, and UPLIZNA.
• The launch of IMDELLTRA generated $81 million in sales during the quarter, with a Phase 3 study showing improved overall survival compared to chemotherapy.
• GAAP earnings per share (EPS) were $3.20, compared to a GAAP loss per share of $0.21 in the first quarter of 2024, influenced by an unrealized gain on the BeiGene, Ltd. equity investment and an Otezla intangible asset impairment charge of $800 million.
• Non-GAAP EPS increased by 24% to $4.90, driven by higher revenues, partially offset by higher operating expenses.
• The company generated $1.0 billion of free cash flow, compared to $0.5 billion in the first quarter of 2024, reflecting a tax deposit made in the first quarter of 2024 and current quarter business performance.
• For the full year 2025, Amgen expects total revenues in the range of $34.3 billion to $35.7 billion and non-GAAP EPS in the range of $20.00 to $21.20.

Sentiment

Score: 8

Explanation: The report is positive due to strong revenue growth, increased profitability, and successful product launches. However, there are some concerns regarding biosimilar competition and certain product sales declines.

Positives

• Strong revenue growth driven by increased product sales and volume.
• Significant increase in non-GAAP EPS, indicating improved profitability.
• Substantial growth in free cash flow, reflecting better business performance.
• Successful launch of IMDELLTRA with promising clinical trial results.
• Double-digit sales growth for several key products.
• Approval of UPLIZNA for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD) in adult patients.
• FDA granted Breakthrough Therapy Designation for subcutaneous blinatumomab in the treatment of adults with relapsed/refractory CD19-positive B-cell precursor acute lymphoblastic leukemia (B-ALL).

Negatives

• Otezla intangible asset impairment charge of $800 million impacted GAAP earnings.
• Decrease in TEPEZZA sales by 10% year-over-year.
• KYPROLIS sales decreased 14% year-over-year due to increased competition.
• Enbrel sales decreased 10% year-over-year due to lower net selling price.
• AMJEVITA/AMGEVITA sales decreased 19% year-over-year due to lower net selling price.
• XGEVA sales increased only 1% year-over-year, with expected sales erosion due to biosimilar competition in the second half of 2025.

Risks

• Biosimilar competition is expected to erode sales of products like Prolia and XGEVA.
• Pricing pressure and reimbursement policies may affect product sales.
• Clinical and regulatory developments could impact current and future products.
• Manufacturing difficulties or delays could constrain sales.
• The company's reliance on third parties for manufacturing activities.
• The company's efforts to collaborate with or acquire other companies, products or technology, and to integrate the operations of companies or to support the products or technology we have acquired, may not be successful.
• There can be no guarantee that we will be able to realize any of the strategic benefits, synergies or opportunities arising from the Horizon acquisition, and such benefits, synergies or opportunities may take longer to realize than expected.
• We may not be able to successfully integrate Horizon, and such integration may take longer, be more difficult or cost more than expected.

Future Outlook

Amgen expects total revenues in the range of $34.3 billion to $35.7 billion and non-GAAP EPS in the range of $20.00 to $21.20 for the full year 2025.

Management Comments

• Demand for our products was strong globally in the first quarter.
• Ongoing new product launches and successful Phase 3 trial results for several products make us feel confident in our long-term growth prospects, said Robert A. Bradway, chairman and chief executive officer.

Industry Context

Amgen's focus on innovative medicines and biosimilars positions it well in a competitive pharmaceutical landscape. The company's growth in key therapeutic areas like oncology, inflammation, and general medicine reflects broader trends in healthcare. The successful launch of new products and positive clinical trial results are crucial for maintaining a competitive edge.

Comparison to Industry Standards

• Amgen's revenue growth of 9% is solid compared to other large-cap pharmaceutical companies, but it's essential to consider the specific growth rates of its key products relative to their respective markets.
• For example, Repatha's 27% sales increase is notable in the competitive cardiovascular market, where companies like Novartis with Leqvio are also vying for market share.
• Similarly, the success of TEZSPIRE in the asthma market puts Amgen in direct competition with companies like AstraZeneca and Sanofi, who also have significant presence in this space.
• Amgen's biosimilar portfolio, while showing some declines in certain products, is a strategic move to capture market share as patents for blockbuster drugs expire, similar to strategies employed by companies like Viatris and Teva Pharmaceuticals.

Stakeholder Impact

• Shareholders will benefit from increased revenues, EPS, and free cash flow.
• Patients will have access to new and innovative medicines.
• Employees may see increased job security and opportunities for advancement.
• The company's performance could positively impact the communities in which it operates.

Next Steps

• Present detailed data from DeLLphi-304 at ASCO in June.
• Present data from a Phase 3 study of Nplate at ASCO in June.
• Continue enrolling patients in various Phase 3 studies for MariTide, TEZSPIRE, rocatinlimab, xaluritamig, bemarituzumab, and LUMAKRAS/LUMYKRAS.
• Initiate a Phase 3 study of first-line IMDELLTRA with carboplatin, etoposide and durvalumab in patients with ES-SCLC by mid-2025.
• Advance blinatumomab subcutaneous administration to a potentially registration-enabling Phase 2 portion of this study with initiation in H2 2025.
• Await regulatory review of TEPEZZA in multiple additional geographies, including with the European Medicines Agency (EMA) where approval is anticipated in H2 2025.
• Await data readout for Part 2 of the Phase 2 chronic weight management study for MariTide in H2 2025.
• Await data readout for a Phase 2 study investigating MariTide for the treatment of Type 2 diabetes mellitus in H2 2025.
• Await data readout for VESALIUS-CV, a Phase 3 CV outcomes study of Repatha, in H2 2025.
• Await data readout for ROCKET ASCEND and ROCKET ASTRO studies evaluating rocatinlimab in H2 2025.
• Await data readout for FORTITUDE-101, a Phase 3 study of bemarituzumab plus chemotherapy, in Q2 2025.
• Await Phase 3 data readout for FORTITUDE-102, a Phase 1b/3 study of bemarituzumab plus chemotherapy and nivolumab, in H2 2025.
• Await data readout for a randomized, double-blind pharmacokinetic similarity study of ABP 206 compared with OPDIVO (nivolumab) in H2 2025.

Key Dates

Keywords

Amgen, Financial Results, First Quarter 2025, Revenues, EPS, Product Sales, IMDELLTRA, TEZSPIRE, Repatha, Biosimilars