Amgen Inc. Q4 FY2025 earnings call

Bob Bradway highlighted Amgen's strong 2025 operational performance with 14 products at blockbuster status, 13 with double-digit sales growth, and 18 with record results. He outlined six areas of momentum for 2026 including Repatha, Evenity, and TestSpire. James E. Bradner discussed R&D progress, including Meritide's Phase III programs, Repatha's Vesalius CV trial results showing reduced cardiovascular event risks, opaziran's OCEAN A study progress, rare disease approvals, oncology updates like Imdeltra's full FDA approval, and biosimilars progress. Murdo Gordon provided a commercial update on sales growth across various products, emphasizing the strength of the portfolio and execution. Peter H. Griffith gave a financial update on 2025 results, R&D spending, free cash flow, and outlined 2026 guidance on revenues, earnings per share, and capital allocation.

In 2025, Amgen Inc. showed strong segment performance. In general medicine, Repatha sales grew 36% year over year, surpassing $3 billion. Evenity sales increased 34% to reach $2.1 billion. Prolia delivered $4.4 billion in sales with 1% year-over-year growth. The rare disease portfolio grew 14% year over year to nearly $5.2 billion, with Eplisna sales increasing 73% year over year to $655 million. TEPEZZA grew 3% to $1.9 billion, and TADNIA sales were $459 million with a 62% year-over-year increase. Inflammation saw TestBio sales grow 52% year over year to nearly $1.5 billion. The innovative oncology portfolio grew 11% year over year to generate $8.7 billion in full-year sales, with Imdeltra delivering $627 million in full-year sales and BLINCYTO up 28% to over $1.5 billion. The biosimilar portfolio had sales increasing 37% to $3 billion, with PAV Blue (biosimilar to EYLEA) reaching $700 million in sales in 2025.

Amgen expects 2026 total revenues to be in the range of $37 billion to $38.4 billion and non-GAAP earnings per share between $21.6 to $23. The revenue range reflects strong performance from key growth drivers and is expected to offset biosimilar competition, price declines, and 340B program impacts. Q1 2026 is expected to have lower mid-single-digit year-over-year growth. The full-year non-GAAP operating margin as a percentage of product sales is projected to be roughly 45% to 46%. Non-GAAP R&D expense is expected to grow low single digits excluding business development. Share repurchases are not expected to exceed $3 billion in 2026, and capital expenditures are expected to be about $2.6 billion.

Biosimilar competition poses a risk, such as accelerated sales erosion for products like Prolia. Uncertainty in clinical trial outcomes, like the slower-than-expected accrual rate in opaziran's OCEAN A study, is a risk. Regulatory challenges, including the FDA's request for Tavneos withdrawal and readjudication of data for nine patients, present risks.

Q: Michael Yee from UBS Financial asked about the portfolio overall in obesity given competitors' combinations with monthly dosing and how Amgen is positioned.

A: James E. Bradner responded discussing Amgen's focus on Meritide across various indications, internal clinical stage assets like AMG five thirteen, and preclinical programs.

Q: Yaron Werber from TD Cowen asked about dasodilumab for primary Sjogren's syndrome, including data timing and Phase II to III reliability.

A: James E. Bradner replied that dasodilumab Phase III studies in Sjogren's syndrome are expected to complete later in the year, and confidence is high due to the medicine's performance against the SI score.

Q: David Amsellem from Piper Sandler asked about the IgG related disease population size and gMG product use.

A: Robert A. Bradway and Murdo Gordon discussed the evolving epidemiology of IgG related disease and positive uptake of Eplisna in gMG, including bio-naive and switch patients.

Q: Salveen Richter from Goldman Sachs asked about dasodilumab in CIDP and Repatha's commercial strategy with Merck's oral PCSK9.

A: James E. Bradner talked about dasodilumab's potential in CIDP due to its mechanism targeting pathologic B cells, and Murdo Gordon discussed Repatha's momentum with Vesalius data and broad prescribing.

Q: Mohit Bansal from Wells Fargo asked about Repatha's primary care prescription percentage and market evolution.

A: Murdo Gordon stated roughly 40% of Repatha prescriptions were from primary prevention patients and expected momentum to continue.

Q: Louise Chen from Scotiabank asked about TEPEZZA and AMG seven thirty two for TED.

A: James E. Bradner discussed TEPEZZA's Phase III study progress and AMG seven thirty two's Phase II enrollment, and Murdo Gordon talked about TEPEZZA's commercial expansion.

Q: Terence Flynn from Morgan Stanley asked about Miratide's Type II diabetes CVOT trial control arm design.

A: James E. Bradner said the specific design of control arms and patient recruitment for Miratide's Phase III studies will be discussed later.

Q: Chris Schott from JPMorgan asked about Miratide's less frequent dosing trade-off and confidence in pushing beyond monthly.

A: Murdo Gordon and James E. Bradner discussed Miratide's potential as a paradigm-changing therapy and no assumed trade-off between less frequent dosing and efficacy.

Q: Umer Raffat from Evercore ISI asked about Tavneos' FDA withdrawal and data readjudication.

A: James E. Bradner explained that Tavneos is for ANCA-associated vasculitis, and the FDA requested a voluntary withdrawal due to concerns about data readjudication for nine patients.

Q: Alex Hammond from Wolfe Research asked about maintaining Pav Lu's leadership with biosimilar launches.

A: Murdo Gordon stated Amgen's strong inroads with retina specialists and ability to compete effectively against innovators.

Q: Courtney Breen from Bernstein asked about Maritide's role in maintenance and less frequent dosing.

A: Murdo Gordon discussed Maritide's potential as a convenient, well-tolerated therapy for weight loss, diabetes, and ASCVD management, applicable for starting patients and those needing long-term treatment.