Amgen(US:AMGN)2025-11-04 22:32Financial Data and Key Metrics Changes - Revenues increased by 12% year over year to $9.6 billion, driven by strong performance across key growth drivers [12][20] - Non-GAAP operating margin was reported at 47%, reflecting significant investments across the business [12][15] - Free cash flow generated in the third quarter was $4.2 billion, indicating operational momentum [15] Business Line Data and Key Metrics Changes - Repatha sales reached $794 million, up 40% year over year, now annualizing at approximately $3 billion [20] - EVENITY delivered $541 million in sales, a 36% increase year over year, with U.S. sales growing 44% [23] - The rare disease portfolio grew 13% year over year to $1.4 billion, with Uplizna sales increasing 46% to $155 million [25] - Tezspire sales rose 40% year over year to $377 million, achieving over $1 billion in sales year to date [27] - The oncology portfolio generated $2.3 billion in sales, growing 9% year over year [29] 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 [30] - Prolia sales increased by 9% year over year to $1.1 billion, although future quarters may see increased competition negatively impacting sales [24] Company Strategy and Development Direction - The company is focused on expanding access to medicines through initiatives like AmgenNow, which offers Repatha at a significantly reduced price [5][23] - Continued investment in manufacturing with over $3 billion planned for the U.S. in 2025, building on over $40 billion invested since 2017 [7][12] - The company aims to drive innovation in areas of high unmet medical need while maintaining rigorous financial discipline [18][19] 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 [4][11] - The company raised its 2025 guidance for total revenues to a range of $35.8 billion to $36.6 billion and non-GAAP earnings per share to between $20.60 and $21.40 [17] - Management highlighted the importance of the VESALIUS-CV study results for Repatha, which demonstrated significant cardiovascular event reduction [61][62] Other Important Information - The company is actively engaging with policymakers to support policies that improve access and protect innovation [10] - The anticipated approval of Uplizna for generalized myasthenia gravis is expected to expand its patient base significantly [36] Q&A Session Summary Question: Confidence in Olpasiran and Business Development Approach - Management expressed strong confidence in Olpasiran's potential, emphasizing its best-in-class properties and the importance of the Ocean A study [46][47] - The return to pre-Horizon debt levels does not significantly impact the company's business development strategy, which remains focused on earlier-stage opportunities [49] 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 [52][53] - R&D expenses are expected to stabilize after a significant increase, with ongoing investments in late-stage programs [54] Question: VESALIUS-CV Results Impact - The VESALIUS-CV results are anticipated to significantly enhance Repatha's market opportunity, with a focus on improving cardiovascular care [59][60] - Management highlighted the importance of these results in promoting Repatha as a solution for primary prevention of cardiovascular events [62][64] Question: New Biosimilar Guidance Impact - The company does not foresee a change in its strategic focus on biosimilars despite new FDA guidance, maintaining confidence in its competitive position [66][67] - Management believes the biosimilar market is performing well and is committed to ensuring continued access to important medicines [69][70]