Amgen Q1 Earnings Call Highlights

Key Points

• Amgen said it delivered a “strong” Q1 with its six key growth drivers accounting for nearly 70% of sales and growing 24% collectively, with standout product momentum such as Repatha +34%, Evenity +27%, TEPEZZA +29%, and a rare-disease portfolio up 25% (Uplizna +188%).
• The company expanded the Phase III MariTide program to include long-term maintenance dosing and a 300-patient switching study from weekly GLP‑1s, pursuing monthly/8‑week/quarterly schedules and reporting improved tolerability with a three-step dose escalation.
• Amgen raised full‑year 2026 guidance to $37.1–$38.5B in revenues and $21.70–$23.10 non‑GAAP EPS while maintaining ~45% non‑GAAP operating margin and strong cash flow, but warned ongoing IRS audits and tax litigation could materially affect future results if adjustments are sustained.

Amgen NASDAQ: AMGN executives said the company delivered a “strong first quarter” and remains positioned to meet its goals for 2026, a year CEO Robert Bradway has previously described as a “springboard year” in which rapidly growing products are expected to offset the impact of patent expirations and heightened competition.

On the call, Bradway highlighted momentum in Amgen’s “six key growth drivers,” which management said generated nearly 70% of quarterly sales and grew 24% in aggregate. He also emphasized disciplined execution across late-stage research and development programs, led by the Phase III program for MariTide in obesity and related conditions.

Commercial performance led by key growth drivers

Chief Commercial Officer Murdo Gordon said 16 products posted double-digit sales growth in the quarter and 17 products are now “annualizing at sales of $1 billion or more.” Overall product sales grew 4% year-over-year, supported by growth in the company’s key franchises, which Gordon said continue to “outpace the impact of losses of exclusivity.”

• Repatha: First-quarter sales of $876 million, up 34% year-over-year. Gordon cited updated ACC/AHA dyslipidemia guidelines and strong physician response to the VESALIUS-CV outcomes data, including subgroup analyses presented at the American College of Cardiology meeting and published in JAMA. He said the subgroup analysis in high-risk patients with diabetes and without significant atherosclerosis showed a 31% reduction in cardiovascular events and that a trend toward lower mortality was observed.
• Evenity: Sales rose 27% to $562 million, with U.S. sales up 35%. Gordon said Evenity holds a 65% share of the U.S. bone builder market and cited significant remaining unmet need among women at very high fracture risk. In Japan, he said more than 900,000 patients have been prescribed Evenity since launch and it leads the category with more than 55% share.
• Tezspire: Sales increased 20% to $343 million, driven by demand across pulmonology and allergy, partially offset by a “burn in channel inventory.” Gordon said a chronic rhinosinusitis with nasal polyps indication is gaining traction.
• Prolia and Xgeva: Combined sales were $1.1 billion, down 32% year-over-year. Gordon said erosion remains in line with expectations and that Amgen anticipates accelerated pressure through the rest of 2026 due to increasing biosimilar competition.
• Rare disease: Portfolio sales rose 25% to $1.2 billion. Gordon highlighted Uplizna sales growth of 188% to $262 million and said demand is rising across all three approved indications. He described strong uptake in generalized myasthenia gravis (GMG), continued momentum in IgG4-related disease, and Uplizna maintaining leadership in NMOSD as the most prescribed FDA-approved therapy in the U.S.
• TEPEZZA: Sales climbed 29% to $490 million. Gordon said more than 25,000 U.S. patients have been treated since launch and pointed to growing prescriber interest and increased endocrinology prescribing. He also cited Phase III data for an on-body injector supporting subcutaneous administration with comparable efficacy to intravenous dosing and said Amgen expects additional global launches in 2026 and beyond following Japan’s 2025 launch.
• Innovative oncology: Portfolio sales grew 25% to $1.8 billion, including IMDELLTRA sales of $258 million and BLINCYTO sales of $415 million (up 12%). Gordon said IMDELLTRA is being administered at more than 1,800 U.S. sites, with most doses in the community setting.
• Biosimilars: Sales increased 14% to $835 million. Gordon said Pavblu, Amgen’s biosimilar to EYLEA, delivered $280 million in the quarter and that specialists value the prefilled syringe format and supply reliability.

Gordon also discussed AmgenNow, the company’s simplified cash-pay option. In response to an analyst question, he said Repatha is offered at $239 per month and that Amgen is seeing interest from cash-paying patients, but he characterized the cash-pay component as “relatively small” compared to total Repatha volumes. He said the program is in the “8,000-9,000 patient range” and also includes Xembify, TEPEZZA, Aimovig, and AMGEVITA.

MariTide Phase III program expands to switching and maintenance studies

Chief Scientific Officer Jay Bradner detailed multiple additions to the MariTide development program, emphasizing its antibody-peptide conjugate design and the potential for monthly or less frequent dosing to reduce treatment burden and improve persistence.

Bradner said Amgen has initiated two long-term extension studies of ongoing Phase III chronic weight management trials. Participants who complete 72 weeks in the parent trial will enter a 48-week extension and receive MariTide monthly, every eight weeks, or quarterly to evaluate maintenance dosing for durable weight loss.

Amgen also announced a new Phase III switching study evaluating patients transitioning from weekly injectable GLP-1 therapies (semaglutide or tirzepatide) to MariTide on an every-eight-week or quarterly schedule. In response to TD Cowen’s Yaron Werber, Bradner said the trial will include 300 subjects with obesity or overweight, include a run-in on weekly therapy, and measure change from baseline body weight after 52 weeks of MariTide as the primary endpoint.

On tolerability, Bradner said Amgen’s experience with three-step dose escalation is “quite positive” and that it further reduced nausea and vomiting compared with prior two-step escalation experience. In the Q&A, Bradner added that when nausea and vomiting do occur, duration tends to be “quite short” over one or several days, and he contrasted MariTide’s stable exposure with “peaks and troughs” seen with daily or weekly dosing regimens.

Pipeline and regulatory updates: Olpasiran, IMDELLTRA expansion, Tavneos, and blinatumomab

Bradner reiterated Amgen’s focus on “disciplined data generation and execution” across Phase III programs beyond MariTide, including cardiovascular and oncology assets.

For Olpasiran, Bradner described the program as a Phase III effort in secondary prevention of cardiovascular events and noted initiation of OCEAN(a)-CCTA to study effects on non-calcified coronary plaque using coronary CT angiography. In response to a question about background therapies, he said Lp(a) levels are not meaningfully reduced by GLP-1 medicines, statins, or PCSK9 inhibitors, and emphasized the company’s focus on a high-risk population with elevated Lp(a).

In oncology, Bradner said IMDELLTRA is being advanced into earlier lines of therapy in extensive-stage small cell lung cancer, including frontline induction and maintenance, and discussed additional trials including DeLLphi-306 in limited-stage disease. He also said Amgen is collaborating with FDA leadership on a “real-world prospective” clinical trial design leveraging electronic health records and real-time data capture, describing it as a potentially important experiment given challenges in trial enrollment and data submission.

Bradner also said Amgen decided to discontinue development of AMG-193, its MTA-cooperative PRMT5 inhibitor, following a comprehensive review.

In rare disease, Bradner noted the European Commission approved Uplizna for generalized myasthenia gravis and said Amgen expects to initiate Phase III studies in autoimmune hepatitis and chronic inflammatory demyelinating polyneuropathy in the second half of the year. He also addressed Tavneos after the FDA “proposed to withdraw” the drug’s approval, saying Amgen believes in its benefit-risk profile and expects to engage further with the agency.

Separately, in response to a question about blinatumomab (BLINCYTO) development, Bradner said Amgen paused enrollment in certain subcutaneous blinatumomab studies after observing “a handful of inflammatory reactions,” noting the company is collecting patient data and in dialogue with the FDA and expects to reopen enrollment “shortly.”

Financial results, guidance increase, and tax dispute disclosures

Chief Financial Officer Peter Griffith reported non-GAAP operating margin of 45% and said non-GAAP R&D spending rose 16% year-over-year, reflecting higher investment in late-stage assets including MariTide, IMDELLTRA, and Olpasiran. Non-GAAP cost of sales was 19.5% of product sales, driven by higher profit-share and royalty expenses and changes in sales mix, which Griffith said are expected to continue pressuring cost of sales in future quarters.

Amgen generated $1.5 billion in free cash flow and spent $700 million on capital expenditures, primarily across U.S. manufacturing sites in Ohio, North Carolina, and Puerto Rico. Griffith reaffirmed expected 2026 capital expenditures of about $2.6 billion, including investment to scale manufacturing capacity for volume growth and a potential MariTide launch.

Griffith also highlighted AI and technology initiatives, citing an example where AI-enabled automation reduced production line clearance time at a manufacturing site from approximately 30 minutes to about two minutes per batch run.

Amgen raised its full-year 2026 guidance ranges:

• Total revenues: $37.1 billion to $38.5 billion
• Non-GAAP EPS: $21.70 to $23.10

Griffith said guidance excludes potential business development transactions. The company also updated expectations for other revenue ($1.7 billion to $1.8 billion), non-GAAP other income/expense ($2.2 billion to $2.3 billion of expense), and a non-GAAP tax rate of 15.0% to 16.5%. He reiterated expectations for full-year non-GAAP operating margin of roughly 45% to 46% and share repurchases not to exceed $3 billion. Amgen paid a dividend of $2.52 per share, up 6% versus the first quarter of 2025.

On tax matters, Griffith said Tax Court litigation covering 2010–2015 remains ongoing, with a decision expected no earlier than the second half of 2026. He also said Amgen is under IRS audit for 2016–2018 and received a draft notice of proposed adjustment in April 2026 asserting significant adjustments tied primarily to profit allocation between the U.S. and Puerto Rico. Griffith said the company disagrees, believes the IRS positions are without merit, and considers its tax reserves appropriate, while noting that sustained adjustments could materially impact financial statements.

Leadership transition in AI and data initiatives

Bradway said David M. Reese will retire at the end of the second quarter and credited him with championing technology change at Amgen, including early emphasis on AI. Bradway said Bradner will build on that foundation while leading AI and data activities across the company.

In the Q&A, CEO Bradway also addressed business development, saying Amgen remains active in evaluating innovation it can add value to, consistent with past practice, while declining to provide specifics.

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.

This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to contact@marketbeat.com.