Executives from Amgen (NASDAQ:AMGN) highlighted broad-based commercial growth, a set of six “key growth drivers,” and several late-stage pipeline programs during a conference session hosted by Leerink Partners. Chief Financial Officer Peter Griffith was joined by Investor Relations leader Casey and Rare Disease head Jasper van Grunsven, who discussed product performance in 2025, priorities for 2026, and longer-term strategic considerations.
2025 performance and key growth drivers
Griffith said Amgen exited 2025 with “strong momentum across the portfolio,” citing a wide base of products contributing to growth. He said 13 products delivered double-digit growth, 14 exceeded $1 billion in annual sales, and 18 delivered record performance. He added that the breadth of performance supported double-digit growth in both revenue and earnings per share in 2025.
Rare disease: UPLIZNA growth and new indications
Griffith said Amgen’s rare disease portfolio delivered $5 billion in 2025 sales, up 14% year-over-year, driven by new patient starts, geographic expansion, and new indications. He pointed to UPLIZNA as an example, saying it grew 73% in 2025, supported by the launch in IgG4-related disease. He said the company expects continued growth in 2026 as that launch progresses and as it builds on a recent generalized myasthenia gravis (gMG) approval and launch.
Griffith also said Amgen plans to initiate additional Phase III studies of UPLIZNA in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy later in the year.
Van Grunsven added that UPLIZNA’s 73% growth was driven by its base NMOSD indication, “very good new patient growth,” and “very strong adherence,” as well as roughly eight months of the IgG4-related disease launch. He said Amgen is seeing uptake across more than 500 active prescribers in IgG4-related disease, including expected rheumatology prescribers and other specialties such as GI. On gMG, he described the market as competitive but still with significant unmet need, arguing that patients cycle through existing therapies relatively quickly. He said early uptake includes both biologic-naïve patients and switches, and he highlighted what he called UPLIZNA’s competitive profile: durable efficacy, a known and well-tolerated safety profile, twice-yearly maintenance dosing, and a “broad set” of gMG sub-indications.
Oncology and biosimilars: BiTE platform and portfolio expansion
In innovative oncology, Griffith said growth is being driven by Amgen’s bispecific T-cell engager (BiTE) platform. He said IMDELLTRA, a 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 disease. He also said Amgen is progressing Xaluritamig, a STEAP1 bispecific T-cell engager, with two ongoing Phase III studies in metastatic castrate-resistant prostate cancer and is evaluating expansion into earlier lines.
On biosimilars, Griffith said the portfolio has generated approximately $13 billion in cumulative sales, and delivered $3 billion of product sales in 2025, up 37% year-over-year. He attributed part of the momentum to uptake of Pavblu, its biosimilar to EYLEA. Looking ahead, he said future growth is expected to be driven by biosimilar candidates to OPDIVO, KEYTRUDA, and OCREVUS, which are in Phase III development.
Pipeline focus for 2026: MariTide, olpasiran, and dazodalibep
Griffith described 2026 as a year of “disciplined data generation” across Phase II and Phase III programs. He reiterated confidence in MariTide as a differentiated treatment for obesity, type 2 diabetes, and obesity-related conditions, emphasizing the prospect of monthly, every-other-month, or quarterly dosing.
Casey said MariTide has six global Phase III studies underway, with additional Phase III studies expected to come online during the year in type 2 diabetes. He said the two most advanced trials are chronic weight management studies evaluating monthly dosing over 72 weeks, with a short, three-step dose escalation period. He also referenced Phase II chronic weight management data, saying the company observed that lower monthly dosing or quarterly dosing could maintain weight loss achieved over 52 weeks for a subsequent 52 weeks, and said quarterly dosing in that maintenance period appeared “very well-tolerated.”
Executives also tied less frequent dosing to potential adherence benefits. Casey said treatment burden and dosing frequency are barriers to long-term persistence, and argued that improved persistence matters because obesity and related conditions are chronic and require chronic treatment to deliver long-term health benefits.
On olpasiran, Griffith said the fully enrolled OCEAN(a) outcomes study continues to progress but remains event-driven, with the aggregate endpoint accrual rate “lower than initial predictions.” He said the company recently pushed out its estimated completion date, while maintaining strong conviction in the program based on evidence supporting elevated Lp(a) as an independent risk factor in heart disease.
For dazodalibep, Griffith said two Phase III studies in Sjögren’s disease are fully enrolled, with study completion expected in the second half of 2026. Van Grunsven described significant unmet need in Sjögren’s disease, discussing both systemic and symptomatic patient groups and noting Phase II data that showed initial efficacy across those areas. Asked about safety considerations, Casey said dazodalibep is engineered to avoid platelet aggregation and thromboembolic events observed with some earlier approaches targeting the same pathway, and said a favorable Phase II safety profile supported advancement into Phase III while noting that larger studies will further inform safety.
2026 financial considerations and M&A approach
Griffith said the company sees strong momentum for the full year, but expects quarterly phasing to follow historical patterns, with the first quarter lighter than subsequent quarters. He cited seasonal Q1 headwinds tied to U.S. insurance dynamics, and said Otezla and IMRALDI typically show lower sales in the first quarter. He added that Otezla faces European generic entry as of January, noting European Otezla sales of $282 million in 2025. He also said Amgen expects accelerated erosion in 2026 for Prolia and XGEVA, including in the first quarter, due to a full year of biosimilar competition. Griffith noted approximately $250 million of inventory build in the fourth quarter of 2025 that could impact first-quarter sales, and said first-quarter non-GAAP operating margin is expected to be the lowest of the year and roughly consistent with Q4 2025, which he said was approximately 43%.
On business development, Griffith said the company returned to the balance sheet position it committed to following the Horizon deal announced in December 2022. He said Amgen remains “structurally agnostic” across potential inorganic activity—acquisitions, licensing, collaborations, and partnerships—while emphasizing a disciplined framework that includes being the best owner or partner, meeting cash-on-cash return thresholds, leveraging existing research strength, and integrating promptly. He also pointed to Horizon integration milestones cited during the discussion, including achieving accretion in the first full year, reaching more than $500 million in pre-tax cost synergies earlier than expected, and strengthening the balance sheet earlier than planned.
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.
