Amgen(AMGN) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Revenues increased by 12% year over year to $9.6 billion, driven by strong performance across key growth drivers [10][18] - Non-GAAP operating margin was reported at 47%, reflecting significant investments across the business [11] - Free cash flow generated in the third quarter was $4.2 billion, indicating operational momentum [12] Business Line Data and Key Metrics Changes - Repatha sales reached $794 million, up 40% year over year, now annualizing at approximately $3 billion [18] - Evenity delivered $541 million in sales, a 36% increase year over year, with a 44% growth in the U.S. [20] - The rare disease portfolio grew 13% year over year to $1.4 billion, with Uplizna sales increasing 46% to $155 million [23] - Tezspire sales rose 40% year over year to $377 million, achieving over $1 billion in sales year to date [25] - The oncology portfolio generated $2.3 billion in sales, growing 9% year over year [26] Market Data and Key Metrics Changes - The biosimilar portfolio saw sales increase by 52% year over year to $775 million, now annualizing at $3 billion [27] - Evenity holds over 60% market share in the U.S. bone builder segment, with significant untapped potential [21] - Repatha is now accessible to over 95% of insured patients in the U.S., with most paying less than $50 out of pocket [19] Company Strategy and Development Direction - The company is focused on expanding access to medicines through initiatives like Amgen Now, which offers Repatha at a significantly reduced price [20] - Continued investment in manufacturing with over $3 billion planned for the U.S. in 2025, building on over $40 billion since 2017 [5] - The company aims to drive innovation in areas of high unmet medical need while maintaining rigorous financial discipline [16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining long-term growth, supported by a broad base of innovative medicines [3] - The company raised its 2025 revenue guidance to a range of $35.8-$36.6 billion and non-GAAP earnings per share to between $20.60 and $21.40 [15] - Management highlighted the importance of the Vesalius CV study results for Repatha, which could significantly impact cardiovascular care [57][59] Other Important Information - The company plans to continue leveraging AI across various stages of the value chain to enhance productivity [12] - Capital expenditures for 2025 are expected to be approximately $2.2-$2.3 billion, focusing on expanding network capacity [13] Q&A Session Summary Question: Confidence in Olpasiran and Business Development Approach - Management remains confident in Olpasiran's potential, emphasizing its best-in-class properties and the importance of the Ocean A study [42][43] - The return to pre-Horizon debt levels does not significantly alter the company's approach to business development, which remains focused on earlier-stage opportunities [44] Question: 2026 Guidance and R&D Expenses - Management discussed key growth drivers and the focus on maintaining industry-leading margins while investing in R&D [46][49] - R&D expenses are expected to stabilize after a significant increase, with ongoing investments in late-stage programs [50][51] Question: Vesalius CV Results Impact - The Vesalius CV study is anticipated to enhance Repatha's market opportunity, with management highlighting its significance in preventing first cardiovascular events [54][57] - The study's results will be shared at the upcoming AHA meeting, emphasizing the need for improved cardiovascular care [59][60] Question: New Biosimilar Guidance Impact - The company does not foresee a change in its strategic focus on biosimilars, viewing the market as performing well despite new guidance [63][66] - Management remains committed to competing effectively in the biosimilar space, regardless of regulatory changes [64][65]