“Biopharmaceutical innovation is a global public good. But it is both risky and expensive to carry out,” writes Tomas Philipson. The former chair of America’s Council of Economic Advisers argues for reforms to European drug pricing https://t.co/O3nvcRVuN1 ...

Financial Data and Key Metrics Changes - In Q1 2025, total revenues were $3 billion, driven by higher collaboration revenue from Sanofi and increased U.S. net sales of EYLEA HD compared to the prior year [41] - Diluted net income per share was $8.22, with net income of $928 million [42] - Gross margin on net product sales was 85%, reflecting higher inventory write-offs and a change in product mix [45] - Free cash flow generated in Q1 was $816 million, with cash and marketable securities totaling $17.6 billion and debt of approximately $2.7 billion [46] Business Line Data and Key Metrics Changes - EYLEA U.S. net sales were $736 million, down 39% year-over-year, primarily due to lower physician demand and increased competition [7][29] - EYLEA HD U.S. sales were $307 million, up 54% year-over-year, with physician unit demand growing by 5% [8][30] - DUPIXENT achieved global net sales of $3.7 billion, representing a 20% year-over-year increase, with U.S. sales growing 19% [32] - Libtayo's global net sales grew 8% year-over-year to $285 million, with U.S. sales reaching $193 million, up 21% [38] Market Data and Key Metrics Changes - The branded anti-VEGF category contracted due to increased usage of low-cost off-label repackaged Avastin, which gained approximately 6 percentage points in market share [7][28] - EYLEA and EYLEA HD captured 41% of the anti-VEGF category, maintaining market leadership despite competitive pressures [28] - DUPIXENT continues to lead in new-to-brand prescription share across all approved indications, except for chronic spontaneous urticaria [11][34] Company Strategy and Development Direction - The company aims to capitalize on multiple near-term opportunities across its portfolio, including product enhancements and new medicine launches [27] - Significant investments in R&D are planned, with approximately 45 product candidates in clinical development [12][41] - The company is focused on maintaining leadership in the anti-VEGF category while promoting the adoption of EYLEA HD as the new standard of care [30] Management's Comments on Operating Environment and Future Outlook - Management acknowledged a mixed performance in Q1 2025, with challenges in the retinal franchise but positive developments in other commercial areas and pipeline advancements [6][7] - The company remains committed to investing heavily in R&D and delivering scientific breakthroughs while maximizing growth opportunities from existing brands [13] - Management expressed confidence in the potential for EYLEA HD and DUPIXENT to continue delivering significant growth [12][34] Other Important Information - The company plans to return capital to shareholders through share repurchases and dividends, with $1.1 billion worth of shares repurchased in Q1 [48] - A new agreement with Fujifilm Diosynth Biotechnologies will invest over $3 billion to nearly double U.S. large-scale manufacturing capacity [46][47] - The company updated its 2025 gross margin guidance to be in the range of 86% to 87% due to higher-than-expected inventory write-offs [49] Q&A Session Summary Question: Can you elaborate on the EYLEA HD CRL for the prefilled syringe? - Management explained that the FDA's questions relate to a third-party component supplier, and they believe the key issue is being addressed. They expect a resolution could be quick, similar to previous CRLs [52][56] Question: How does the company prioritize indications for Factor XI antibodies? - The company prioritizes indications based on the potential to demonstrate benefits in anticoagulation and bleeding risk profiles, with plans to enroll in phase three studies this year [61][63] Question: What are the updated thoughts on foundation funding for EYLEA? - Management discussed the complexities of patient assistance funding and the potential for a matching program to stimulate contributions from others, emphasizing the need for broader support [66][71] Question: Is there acknowledgment of unsatisfactory regulatory performance? - Management took responsibility for the CRLs, attributing them to increased scrutiny by the FDA on contract manufacturers and expressing confidence in their regulatory team's capabilities [87][90]