AMGEN Q1 FY26 earnings call AMGN

Management reiterated its framing of 2026 as a 'springboard year' in which rapidly growing products offset the financial impact of patent expirations and increased competition while the next generation of molecules advances through Phase III. Q1 product sales grew 4%, with 16 products delivering double-digit-or-better growth and 17 products now annualizing at $1 billion or more. On the strength of the quarter, Amgen raised full-year 2026 guidance for both revenue ($37.1B–$38.5B) and non-GAAP EPS ($21.70–$23.10). Guidance excludes any potential business development transactions.

The six key growth drivers — Repatha, EVENITY, TEZSPIRE, plus the rare disease, innovative oncology, and biosimilars portfolios — collectively grew 24% year-over-year to $5.6 billion, representing almost 70% of total product sales. This momentum is designed to more than offset erosion in legacy brands, most notably Prolia and XGEVA, whose combined sales fell 32% to $1.1 billion following loss of exclusivity. Management said this demonstrates Amgen's ability to grow through a period of patent expiration.

Amgen disclosed additional Phase III MariTide studies focused on longer-term maintenance and switching. Two long-term extensions of ongoing chronic weight management trials will move patients who completed 72 weeks into a 48-week extension dosed monthly, every 8 weeks, or quarterly. A new SWITCH study (300 subjects) will run patients in on weekly semaglutide or tirzepatide before switching to MariTide on an every-8-week or quarterly schedule, with a primary endpoint of change from baseline body weight at 52 weeks. Management highlighted that 3-step dose escalation further reduced rates of nausea and vomiting versus prior 2-step experience, attributing tolerability to the antibody backbone's smooth, stable drug exposure.

Repatha grew 34% to $876 million, supported by VESALIUS-CV data showing a 31% reduction in major cardiovascular events in high-risk diabetes patients without known atherosclerosis, published in JAMA and presented at ACC. Updated ACC/AHA dyslipidemia guidelines reinforce earlier, lower LDL-C targets and broader Lp(a) testing. Olpasiran, a siRNA delivering greater than 95% reduction in Lp(a) with quarterly dosing, continues in the Phase III OCEAN(a) trial (~7,300 patients with Lp(a) over 200) and the newly initiated OCEAN(a)-CCTA study measuring noncalcified coronary plaque.

Rare disease grew 25% to $1.2 billion, led by UPLIZNA up 188% to $262 million (with a new European Commission approval in gMG) and TEPEZZA up 29% to $490 million (with positive Phase III data for a subcutaneous on-body injector). The innovative oncology portfolio grew 25% to $1.8 billion; IMDELLTRA contributed $258 million and is emerging as standard of care in second-line small cell lung cancer, with first-line maintenance median overall survival of 25.3 months in DeLLphi-303. Amgen discontinued PRMT5 inhibitor AMG 193 and paused enrollment in some subcutaneous blinatumomab studies after inflammatory reactions.

Amgen detailed tangible AI gains: antibody lead optimization accelerated by 50%, a proprietary clinical-trial site-selection model improving enrollment rates by up to threefold, and large language models plus agentic AI aiding regulatory filing preparation. In manufacturing, AI-enabled automation reduced production line clearance time at one site from about 30 minutes to roughly 2 minutes per batch run. Jay Bradner will lead AI and data transformation at the enterprise level following the retirement of Dave Reese at the end of Q2.

The tax court litigation covering 2010–2015 remains ongoing, with a decision expected no earlier than the second half of 2026. In April 2026, Amgen received a draft Notice of Proposed Adjustment (NOPA) from the IRS for tax years 2016–2018, asserting significant adjustments primarily related to allocation of profits between the United States and Puerto Rico. Management said the adjustments, if sustained in full, could have a material impact on financial statements, but disagrees with the draft NOPA and believes its tax reserves are appropriate.