• Total Revenue: $3 billion for Q1 2025.
• Net Income: $928 million for Q1 2025.
• Diluted EPS: $8.22 for Q1 2025.
• Sanofi Collaboration Revenue: Approximately $1.2 billion, with $1 billion related to collaboration profits.
• EYLEA US Net Sales: $736 million, down 39% year-over-year.
• EYLEA HD US Net Sales: $307 million, up 54% year-over-year.
• Dupixent Global Net Sales: $3.7 billion, up 20% year-over-year on a constant currency basis.
• Dupixent US Net Sales: $2.6 billion, up 19% year-over-year.
• Libtayo Global Net Sales: $285 million, up 8% year-over-year on a constant currency basis.
• Free Cash Flow: $816 million for Q1 2025.
• Cash and Marketable Securities: $17.6 billion as of the end of Q1 2025.
• Debt: Approximately $2.7 billion as of the end of Q1 2025.
• Gross Margin Guidance: Updated to 86% to 87% for 2025.
• Share Repurchases: Approximately $1.1 billion worth of shares repurchased in Q1 2025.
• Quarterly Dividend: $0.88 per share, with the next payment in June.

• Warning! GuruFocus has detected 3 Warning Signs with REGN.

Release Date: April 29, 2025

For the complete transcript of the earnings call, please refer to the full earnings call transcript.

Positive Points

• Dupixent achieved a 20% year-over-year increase in global net sales, driven by strong demand across all approved indications.
• EYLEA HD sales grew by 54% year-over-year, maintaining its position as a leader in the anti-VEGF category.
• Regeneron Pharmaceuticals Inc (NASDAQ:REGN) has a robust pipeline with approximately 45 product candidates in clinical development, including four regulatory approvals and nine regulatory submissions in 2025.
• Libtayo's US sales increased by 21% year-over-year, establishing it as a cornerstone therapy for advanced non-melanoma skin cancer.
• The company is making significant investments in R&D and manufacturing, with over $7 billion planned for US expansions to support growth and innovation.

Negative Points

• EYLEA US net sales declined by 39% compared to the first quarter of the previous year, impacted by increased competition and lower wholesaler inventory levels.
• The FDA issued a complete response letter for the EYLEA HD prefilled syringe, delaying its approval and impacting potential sales growth.
• Regeneron Pharmaceuticals Inc (NASDAQ:REGN) faces challenges from increased use of low-cost off-label Avastin due to patient affordability issues.
• The company has experienced multiple complete response letters (CRLs) and regulatory delays, raising concerns about its regulatory performance.
• There is uncertainty regarding the reopening of foundation funding for patient assistance, which affects the affordability of EYLEA for some patients.

Q & A Highlights

Q: Regarding the EYLEA HD CRL for the prefilled syringe, can you elaborate further on the question posed by the FDA? How does this compare to the original EYLEA HD CRL? A: Leonard Schleifer, CEO, explained that the FDA's question relates to a third-party component supplier. The supplier has responded to the FDA's request for information. The situation is similar to a previous CRL that was resolved quickly, but the timeline for resolution remains uncertain.

Q: On your factor XI antibodies, how do you prioritize which indications to pursue, and what is the timing for launches? A: George Yancopoulos, Chief Scientific Officer, stated that they prioritize indications where they can demonstrate both anticoagulation benefits and reduced bleeding risks. They have not disclosed all indications or timelines but are enrolling Phase 3 studies this year.

Q: Any updates on when foundation funding might reopen, and how quickly could volumes shift back to branded agents from generic Avastin? A: Leonard Schleifer explained that Regeneron is considering a matching program to encourage other companies to contribute to patient assistance foundations. The timing for reopening depends on other companies' participation.

Q: Can you confirm if the component in the prefilled syringe is the same as the one approved in Europe? A: Leonard Schleifer confirmed that the component is the same as the one approved in Europe, which has been used safely for months. The FDA has its own set of questions, but the European approval gives confidence in resolving the issues.

Q: How are you engaging with Washington leadership to address political risks affecting the biopharmaceutical industry? A: Leonard Schleifer emphasized the importance of maintaining scientific integrity and experience within regulatory bodies. Regeneron is actively engaging with policymakers to ensure that science continues to guide healthcare decisions.

For the complete transcript of the earnings call, please refer to the full earnings call transcript.