Amgen Touts Broad Portfolio Momentum, MariTide Milestones and Repatha Access Push at TD Cowen Conf

Amgen NASDAQ: AMGN executives highlighted broad-based commercial momentum, a focus on long-term growth drivers, and several upcoming pipeline milestones during a fireside chat at the 46th Annual TD Cowen Healthcare Conference.

Portfolio momentum and growth drivers

Amgen said it exited 2025 with “strong momentum across the portfolio,” reporting that 13 products delivered double-digit growth, 14 products exceeded $1 billion in annual sales, and 18 delivered record performance. Management said this breadth supported double-digit growth in both revenue and earnings per share in 2025.

Executives pointed to six key growth drivers: Repatha, EVENITY, TEZSPIRE, and the company’s rare disease, innovative oncology, and biosimilars portfolios. Repatha, EVENITY, and TEZSPIRE each grew more than 30% year-over-year in 2025 and delivered record sales, which Amgen characterized as multi-billion-dollar global franchises with runway “for the rest of the decade.”

In rare disease, Amgen said the portfolio delivered $5 billion in 2025 sales, up 14% year-over-year, driven by reaching new patients, geographic expansion, and new indications. UPLIZNA was highlighted as an example, growing 73% in 2025 following its IgG4-related disease launch.

Oncology and biosimilars updates

In innovative oncology, Amgen emphasized its bispecific T-cell engager (BiTE) platform. The company said IMDELLTRA, its DLL3-targeting BiTE, has “rapidly become the standard of care in second-line or later small cell lung cancer,” with three phase III studies underway in earlier-stage small cell lung cancer. Amgen also discussed xaluritamig, described as a first-in-class STEAP1 BiTE, with two ongoing phase III studies in metastatic castrate-resistant prostate cancer and potential expansion into earlier lines of treatment.

Amgen’s biosimilars portfolio generated $3 billion in 2025 sales, up 37% year-over-year. The company attributed part of that momentum to the uptake of PAVBLU, its biosimilar to EYLEA. Management said future biosimilars growth is expected to be driven by candidates to OPDIVO, KEYTRUDA, and Ocrevus, which are all in phase III development.

During the Q&A, executives said they were “really pleased” with PAVBLU’s performance and noted the company believes it delivered about $700 million in total sales last year as the only biosimilar on the market. When asked about timing for additional biosimilar entrants, Amgen’s team said “time will tell,” citing multiple factors that affect when biosimilars enter.

Pipeline: MariTide, olpasiran, and dazodalibep

Amgen described 2026 as a “disciplined data year” across multiple phase II and phase III programs supporting long-term growth.

• MariTide: The company reiterated confidence in MariTide as a differentiated treatment candidate for obesity, type 2 diabetes, and obesity-related conditions. Executives emphasized that MariTide is the only late-stage therapy they cited offering the potential for monthly, every-other-month, or quarterly dosing, and discussed an interest in improving titration (including a “3-step titration”) alongside a target profile of weight loss “in the mid-20s” and impact on cardiometabolic measures such as HbA1c. Amgen also said it is studying obesity-related conditions including ASCVD, heart failure, and sleep apnea, and that a “whole suite of evidence” will matter for both payers and competition.
• Olpasiran (OCEAN(a)): Amgen said the fully enrolled cardiovascular outcomes study remains event-driven, but the aggregate endpoint accrual rate is lower than initial predictions. Management noted it recently pushed out its estimated completion date, while maintaining conviction based on genetic and epidemiologic evidence linking elevated Lp(a) with heart disease risk.
• Dazodalibep: The company said two phase III studies in Sjögren’s disease are now fully enrolled, with study completion expected in the second half of 2026. In Q&A, Amgen described the diagnosed Ro or RF positive population as roughly 350,000 patients and called the disease “highly heterogeneous,” with room for multiple therapies depending on sequencing and value propositions. The company said it is studying both systemic and symptomatic populations in separate phase III trials and will “follow the data” before making commercial decisions, including pricing and positioning.

Access, pricing, and Repatha’s AmgenNow program

Amgen’s leadership attributed its access performance to early integration of payer considerations into development, building evidence from clinical trials and real-world data to support physician and payer decision-making. The company said this approach helps address access as a “forethought rather than afterthought.”

Repatha was discussed as a key example. Amgen said there are more than 100 million individuals worldwide with elevated LDL, but only about 5% are on a PCSK9 today, with Repatha as the market leader. Management said Repatha is now preferred on “virtually every formulary” in the U.S. across Medicare and commercial plans, with average copays below $50 per month and more than half of Medicare patients no longer needing prior authorization.

Executives also highlighted what they described as primary prevention outcomes data for Repatha, citing reductions including 36% in first heart attack, 25% in MACE, and 20% in all-cause mortality. To reach patients who remain uninsured, in high-deductible plans, or facing other access challenges, Amgen discussed AmgenNow, a direct-to-patient program priced at $239 per month. The company said the program launched in October and has enrolled more than 5,000 U.S. patients so far.

On competitive dynamics in lipid lowering, Amgen said its focus is to increase penetration among the 95% of patients not yet treated with PCSK9 therapy, rather than “fight over” the current treated population. Management added that having outcomes data in both primary and secondary prevention provides a differentiator as new competitors enter.

2026 financial phasing and headwinds

Senior Vice President of Finance Justin Claeys reminded investors that the first quarter is historically lighter for Amgen. He cited typical first-quarter U.S. insurance-cycle headwinds from benefit plan changes, reverifications, and higher patient copays. He also said Otezla and Enbrel tend to have lower first-quarter sales relative to subsequent quarters.

Claeys added that as of January, Otezla now faces European generic entry, noting European Otezla sales were $282 million in 2025. He also said the company continues to expect accelerated erosion in 2026 for Prolia and Xgeva, including the first quarter, due to a full year of biosimilar competition. Additionally, Amgen saw approximately $250 million of inventory build in the fourth quarter of 2025 that could potentially impact first-quarter sales.

Consistent with lower first-quarter sales, Claeys said the company expects first-quarter non-GAAP operating margin to be the lowest of the year and roughly consistent with the fourth quarter of 2025, which he noted was approximately 43%.

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.

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