Amgen Inc. Q3 FY2025 earnings call

• Amgen delivered strong Q3 performance with 12% revenue growth and 14% volume growth. 16 products had double-digit growth and 14 are annualizing at over $1 billion in sales.
• Launched AmgenNow, a direct-to-patient platform for Repatha. Invested over $3 billion in U.S. manufacturing this year, with over $40 billion invested in manufacturing and R&D since 2017.
• In General Medicine, Repatha showed benefits in primary prevention of heart attacks/strokes. In Bone Health, EVENITY has strong performance with room for growth. In Rare Disease, UPLIZNA has growth in new indications. In Inflammation, TEZSPIRE is well-positioned. In Oncology, IMDELLTRA, BLINCYTO, and Xaluritamig are advancing.
• Biosimilars continue to deliver results with over 50% y/y revenue growth.

In the third quarter, revenues increased 12% year-over-year to $9.6 billion. Biosimilars saw over 50% year-over-year revenue growth, annualizing at roughly $3 billion. The rare disease portfolio grew 13% year-over-year to $1.4 billion, now annualizing at over $5 billion. Repatha had $794 million in Q3 sales, up 40% year-over-year and annualizing at approximately $3 billion. EVENITY had $541 million in sales, up 36% year-over-year. TEZSPIRE had $377 million in sales, up 40% year-over-year. The innovative oncology portfolio grew 9% year-over-year, generating $2.3 billion in Q3 sales.

Amgen is raising 2025 guidance for total revenues to the range of $35.8 billion to $36.6 billion and non-GAAP earnings per share to between $20.60 and $21.40. Other revenue is expected to be approximately $1.5 billion in 2025. Non-GAAP R&D expenses are expected to grow at a mid-20s percentage rate. Non-GAAP OI&E is expected to be in the range of $2.1 billion to $2.2 billion. Non-GAAP tax rate is expected to be in the range of 15.0% to 16.5%. WEZLANA in the U.S. is not expected to have sales in the fourth quarter.

• FORTITUDE-102, a Phase Ib/III study of bemarituzumab plus chemotherapy and nivolumab in first-line gastric cancer was stopped for inadequate efficacy. - Potential policy changes that could impact biosimilar uptake in the U.S., as seen in concerns about generic drug market abuses.

Q: With Olpasiran, you mentioned best-in-class in the context of a competitive landscape out there. And you also noted that the event rate for the OCEAN(a) outcome study is lower than you expected. Could you just speak to your confidence in this program and what the event rate means for a base case readout, whether it's now in 2027 versus year-end '26?

A: James Bradner stated conviction remains strong in Olpasiran, noting the clear genetic association for Lp(a) in cardiovascular disease and Olpasiran's best-in-class properties. OCEAN(a) is an event-driven study, and they will update on the primary analysis date as the study matures.

Q: Peter, I was just wondering, high level, I know you're going to give 2026 guidance at this point, but maybe you could walk us through some of the puts and takes that we should think about heading into 2026. And then, Jay, just one clarification on ROCKET ASTRO. I noticed you completed that trial and it said the safety was consistent. Just wondering if there was any gastrointestinal ulcerations in that study.

A: Peter Griffith discussed key growth drivers and the focus on disciplined capital allocation, investing in research and development of later-stage pipeline. James Bradner stated ROCKET ASTRO study met co-primary endpoints at 24 weeks, with safety consistent and GI side effects mostly mild in nature Q: Congrats on the quarter. We're curious about the VESALIUS-CV results and how you expect them to impact the overall market opportunity for Repatha? And also what should we look for in the details when you present them at AHA? And related to that, just any lessons learned that you can apply to Olpasiran?

A: James Bradner and Murdo Gordon discussed the significance of VESALIUS-CV results in primary prevention of heart attacks/strokes, looking forward to sharing detailed data at AHA. Lessons learned include working with great teams and emphasizing the room for improvement in cardiovascular care. For Olpasiran, similar learnings apply to conducting global studies.

Q: Great. Maybe just a question for Jay. The second year of the MariTide data is expected by year-end. We know you're looking at three different things. You're looking at the same dose, lower dosing, going to placebo and you're testing Q12 weeks in that study. There's no Q8 weeks. Any sense sort of -- is this going to be in a medical meeting? And can you give us any sense kind of what to really expect and put it in context?

A: James Bradner stated the Part 2 of the Phase II chronic weight management study will contribute to maintenance experience, testing quarterly dosing, low dose monthly, and comparing to placebo and continued treatment. Data will inform maintenance strategy and Phase III designs, with more disclosure to come Q: Bob, your comment kind of on the biosimilar sector struck with me. I'm wondering if you could highlight what you think needs to change from a policy perspective to encourage even more uptake of biosimilars. For example, the #1 selling adalimumab product is still HUMIRA and not AMJEVITA. How can you as a biosimilar leader really encourage more use of these products?

A: Robert Bradway discussed differences in Part B and Part D medicines, market dynamics evolving differently. Confident AMGEVITA will be successful in the long term, with a safe and reliable supply of true biosimilars doing well over time Q: This is Mike DiFiore in for Umer. I just want to go back to the MariTide Phase II trial for a bit. There is some confusion on whether we'll get two-year weight loss data in the upcoming Part 2 readout of the MariTide obesity Phase II trial. So can you clarify the design, especially as it relates to the washout post week 52? And since most of these patients will have lost weight in year one, isn't it reasonable to assume that weight loss in year two, Part 2 will be a lot less in year one Part 1?

A: James Bradner explained the Part 2 study is a maintenance study testing quarterly dosing, low dose monthly, and comparing to placebo and continued MariTide. The study is designed to inform Phase III and maintenance strategy, with patients who achieved >15% weight loss in Part 1 randomized, and power to make significant insights not strong but will provide useful information Q: So thank you for all the updates. I was just hoping that you could maybe just call out the top two or three pipeline cards that are turning over that could be most impactful for Amgen in the next 6 to 12 months that we should be focused on?

A: James Bradner highlighted the VESALIUS-CV results to be shared at AHA, progress of IMDELLTRA in small cell lung cancer, and development of BLINCYTO and Xaluritamig in oncology as key pipeline cards with significant impact in the next 6-12 months