Amgen Inc. Q2 FY2025 earnings call

• Bob Bradway noted Amgen delivered strong Q2 results with 9% revenue growth and 13% volume growth, with 15 products achieving double-digit sales growth. Focused on four areas: General Medicine, Rare Disease, Inflammation, and Oncology, all performing well. Emphasized the importance of innovation and engagement with government officials on pricing and access.
• Murdo Gordon detailed segment performances, including strong growth in General Medicine (Repatha, EVENITY), Rare Disease, Inflammation (TEZSPIRE), Oncology, and Biosimilars.
• James Bradner discussed R&D pipeline progress, including MariTide data, olpasiran, UPLIZNA, oncology programs like IMDELLTRA, BLINCYTO, and xaluritamig, highlighting late-stage program advancements.
• Peter Griffith provided financial updates, 2025 guidance, discussed capital expenditures, dividends, and business development transactions, including expected R&D expense growth and sales outlook for certain products.

General Medicine: Repatha generated $696 million in Q2, up 31% year-over-year. EVENITY saw sales of $518 million, a 32% year-over-year increase. Prolia sales declined 4% year-over-year to $1.1 billion due to lower net selling price. Rare Disease: Grew 19% year-over-year, delivering nearly $1.4 billion in sales for the quarter, annualizing over $5 billion. TEPEZZA grew 5% to $505 million, and UPLIZNA increased 91% to $176 million. Inflammation: TEZSPIRE had sales up 46% year-over-year to $342 million. Oncology: The innovative oncology portfolio grew 14% year-over-year to $2.2 billion, with BLINCYTO at $384 million (+45% year-over-year) and IMDELLTRA at $134 million. Biosimilars: Sales grew 40% year-over-year to $661 million, with PAVBLU reaching $130 million.

• Expect 2025 total revenues in the range of $35.0 billion to $36.0 billion and non-GAAP earnings per share between $20.20 and $21.30.
• Non-GAAP operating margin as a percentage of product sales is expected to be roughly 45%.
• Non-GAAP R&D expense is expected to grow over 20% in 2025.
• WEZLANA and AMJEVITA sales in the U.S. are expected to fluctuate with no sales in the third quarter.

• Discussion of IP concerns in the industry, with emphasis on the importance of IP protection for R&D investments.
• Mention of compounding issues, though Amgen's antibody-based molecule MariTide is not directly affected by compounding in the same way as peptides and small molecules, but general concerns about compounding impacting the industry and patients.

Q: Yaron Werber asked about granularity of MariTide data in Q4 2025.

A: James Bradner said data from the Phase II type 2 diabetes study and Part 2 chronic weight management studies are expected in Q4 2025 with more to share later.

Q: Salveen Richter asked about Medicaid MFN and DTC efforts.

A: Robert Bradway stated reform is needed in U.S. healthcare, Amgen supports innovation while making medicines more accessible, and they work with the administration to find a path forward.

Q: David Amsellem asked about appetite for M&A in rare diseases.

A: Robert Bradway said Amgen remains interested in rare disease, will look to grow organically and via licensing/acquisitions, and is mindful of executing on late-stage programs.

Q: Courtney Breen asked about MariTide's three-step dose escalation.

A: James Bradner explained the smooth dose escalation, low risk of serious GI events, and the study guiding optimal long-term maintenance therapy.

Q: Umer Raffat asked about VESALIUS-CVOT event rate accumulation.

A: James Bradner said the readout is based on accumulated events in the primary prevention study.

Q: Terence Flynn asked about bemarituzumab's filing timeline.

A: James Bradner said they're excited about bemarituzumab, adjusted date range for the triplet study, and regulatory strategy integrates data sets.

Q: Chris Schott asked about Repatha's primary prevention study.

A: James Bradner and Murdo Gordon discussed the opportunity for Repatha in primary prevention, current high-risk patient uptake, and the trial's potential to reinforce guidelines.

Q: Matthew Phipps asked about AMG 732 in thyroid eye disease.

A: James Bradner said AMG 732 is a next-gen IGF-1R targeting mAb in Phase II, administered subcutaneously.

Q: Dave Risinger asked about biosimilars and IV vs subcu uptake.

A: Murdo Gordon and James Bradner discussed biosimilar portfolio growth, regulatory dynamics, and watching hyaluronidase uptake in oncology.

Q: Evan Seigerman asked about IMDELLTRA's volume growth.

A: Murdo Gordon and Robert Bradway said growth is from refractory small cell lung cancer patients, positive launch, and lessons for the BiTE portfolio.

Q: Alex Hammond asked about biosimilar regulatory changes and long-term guidance.

A: James Bradner and Murdo Gordon discussed potential regulatory changes favoring biosimilars, technical challenges, and market development.

Q: Mohit Bansal's question (via Sadia Rahman) about TEZSPIRE COPD program.

A: James Bradner said they're confident in TEZSPIRE's mechanism, distinct from competitor's molecule, and conducting experiments with AZ.

Q: Luca Issi asked about obesity molecules and orals.

A: Robert Bradway, James Bradner, and Murdo Gordon discussed Amgen's interest in orals, MariTide's differentiation, and market projection for orals vs injectables.

Q: Geoffrey Meacham asked about MariTide Phase III changes.

A: James Bradner said no changes to Phase III program post-ADA, strong enrollment, and interest in broader peripheral indications.

Q: Carter Gould asked about IP and compounding in obesity.

A: Robert Bradway said IP is critical, compounding not a direct issue for Amgen's antibody-based molecule, and concerns about compounding impacting the industry.