AMGEN INC Q4 FY2024 earnings call

• General medicine: Repatha and EVENITY showing strong growth; Repatha has potential in primary prevention with the VESALIUS Phase III study; EVENITY has significant unmet need with over 90% of very high-risk patients not treated.
• Rare diseases: TEPEZZA expected to expand internationally with regulatory approvals; UPLIZNA has potential in new indications like IgG4-related disease and generalized Myasthenia Gravis.
• Inflammation: TEZSPIRE continuing strong growth with potential in COPD and other respiratory indications.
• Oncology: BLINCYTO, IMDELLTRA, and bispecific platforms showing growth with new indications and clinical data; innovative oncology portfolio contributing strongly.
• R&D: MariTide with promising weight loss profile; olpasiran in cardiovascular risk reduction; key Phase III trials and approvals in various portfolios; AI integration in R&D and commercial operations.
• Execution: Strong coordination across R&D, manufacturing, and commercial teams; successful biosimilar launches and pipeline advancements.

In 2024, product sales grew 11% year-over-year in the fourth quarter, with full-year product sales growing 19%. Repatha sales increased 36% in 2024, reaching over $2.2 billion, accounting for a significant portion of general medicine sales. EVENITY sales increased 35% in 2024, reaching almost $1.6 billion. The rare disease portfolio delivered over $4.5 billion in sales in 2024, with TEPEZZA generating $1.9 billion. TEZSPIRE in inflammation had nearly $1 billion in sales in 2024, a 71% year-over-year increase. The oncology portfolio contributed almost $8 billion in sales for the full year, with BLINCYTO sales growing 41% to over $1.2 billion. Biosimilar products had sales of $2.2 billion in 2024, an increase of 16% year-over-year, with launches like PAVBLU and upcoming WEZLANA and BEKEMV.

Amgen expects 2025 total revenues to be in the range of $34.3 billion to $35.7 billion and non-GAAP earnings per share between $20 and $21.20. Growth drivers include Repatha, EVENITY, TEZSPIRE, innovative oncology, rare disease, and biosimilars. Expect R&D spending to grow mid-teens in 2025, operating margin as a percentage of product sales to be roughly 46%, and capital expenditures of approximately $2.3 billion in 2025.

• Regulatory and political changes that could impact operations and sales.
• Declining net prices across the portfolio and losses of exclusivity, such as denosumab patent expiration.
• Intense biosimilar competition affecting sales and margins.

Q: On 514, the one on clinical hold for obesity, what's the mechanism of action?

A: AMG 513 is a novel investigational medicine for obesity in Phase I investigation, mechanism of action not disclosed.

Q: How is the Part D redesign factoring into projections?

A: The Part D redesign is relatively neutral for products like Repatha which tend to do well with capped and smooth out-of-pocket costs.

Q: Thoughts on KRYSTEXXA growth runway and biosimilar competition?

A: KRYSTEXXA had strong growth in 2024; severe uncontrolled gout has many patients, and there are opportunities for growth with pipeline assets; international launches and expansion for TEPEZZA.

Q: Thoughts on MariTide and obesity portfolio?

A: MariTide has promising weight loss profile; Amgen has talent and pipeline for obesity with various mechanisms and administration methods.

Q: Lessons from Repatha VESALIUS-CV outcome study and leveraging for other programs?

A: Learned from Repatha's secondary prevention use, which helps with VESALIUS-CV study; insights applied to olpasiran's Phase III program.

Q: Stance on looking overseas for clinical-stage assets and M&A post-Horizon?

A: Open to business development globally, looking for opportunities to add value with molecules from around the world.

Q: Interim look on MariTide Part 2 and ADA presentation?

A: Part 2 of Phase II study expected late 2025; Phase II Part 1 data to be presented at ADA meeting in June 2025.

Q: Plans for new olpasiran Phase III trial?

A: Intend to initiate new olpasiran Phase III trial in second half 2025 or first half 2026 for primary prevention.

Q: Growth in TEPEZZA U.S. and internationally?

A: TEPEZZA growth in U.S. focuses on broadening prescriber base; internationally, Japan launch and 7 other markets expected; first quarter sales may be lower due to insurance and purchasing patterns.

Q: Indication for MARITIME trials starting in first half 2025?

A: MARITIME Phase III program focuses on chronic weight management, cardiovascular disease, kidney disease, type 2 diabetes, etc.; design principles premature to discuss.

Q: Biosimilar business, especially PAVBLU?

A: PAVBLU launch going well; Amgen is a world leader in biosimilars, with strong retina specialist response; aiming for industry-leading franchise.

Q: Rocatinlimab Phase III ROCKET program readouts?

A: Rocatinlimab's ROCKET program will generate data on safety, tolerability, and efficacy in various studies throughout 2025.

Q: China commercial opportunity and BeiGene partnership?

A: China business performing well; Amgen-affiliate and BeOne partnerships going well, with KYPROLIS, BLINCYTO, and XGEVA performing well.

Q: Denosumab biosimilar erosion cadence?

A: Biosimilar erosion for denosumab is back-half loaded, with different slopes for XGEVA and Prolia due to different indications.