REGN Q1 Earnings Call: Pipeline Progress and EYLEA Headwinds Dominate Discussion

Biotech company Regeneron (NASDAQ: REGN) missed Wall Street’s revenue expectations in Q1 CY2025, with sales falling 3.7% year on year to $3.03 billion. Its non-GAAP profit of $8.22 per share was 3% below analysts’ consensus estimates.

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StockStory’s Take

Regeneron’s first quarter results reflected significant headwinds in its core retinal franchise, as management pointed to the contraction of the branded anti-VEGF market and increased use of lower-cost alternatives as key factors. CEO Leonard Schleifer specifically cited a funding gap at patient assistance foundations as a catalyst for more patients and physicians turning to off-label Avastin over EYLEA, resulting in a notable decline in EYLEA sales. Management also discussed the impact of lower inventory levels and persistent competitive pressures across key products.

Looking forward, Regeneron’s leadership emphasized the company’s pipeline momentum and anticipated regulatory decisions as major drivers of future growth. Dr. George Yancopoulos highlighted upcoming pivotal data readouts and several regulatory submissions across immunology, oncology, and rare diseases. Management pointed to potential label expansions for EYLEA HD, continued momentum for Dupixent in new indications, and new product launches in hematology as core to Regeneron’s growth strategy in the coming quarters.

Key Insights from Management’s Remarks

Management attributed the quarter’s performance to a combination of market headwinds in ophthalmology and strong advances across the broader portfolio. Notably, the decline in EYLEA sales was offset by growth in Dupixent and pipeline progress.

• EYLEA and EYLEA HD Dynamics: Management cited a reduction in branded anti-VEGF market size, driven by funding gaps at copay assistance foundations. This led to a shift toward low-cost, off-label Avastin. Lower wholesaler inventory levels and increased competition further weighed on EYLEA sales. EYLEA HD, however, grew compared to last year and maintained steady sequential sales as physician demand improved modestly.
• Regulatory Setbacks: The FDA’s complete response letter (CRL) for the EYLEA HD pre-filled syringe was highlighted as a disappointment. CEO Leonard Schleifer explained that the CRL centered on a question for a third-party component supplier and not on the product’s safety or efficacy. The resolution timeline remains uncertain, although management expressed optimism given the same device is already approved in Europe.
• Dupixent Growth and New Indications: Dupixent continued to see strong growth across all approved indications and geographies, with additional launches in chronic spontaneous urticaria and COPD supporting momentum. Management emphasized favorable payer coverage and new direct-to-consumer campaigns for COPD as key commercial levers.
• Oncology and New Launches: Libtayo saw increased share in non-melanoma skin cancer and lung cancer markets. The company is preparing for potential U.S. approvals of linvoseltamab and odronextamab in hematology, as well as label enhancements for EYLEA HD and Libtayo.
• Pipeline Progress: Regeneron advanced 45 product candidates in clinical development, with several regulatory submissions and anticipated pivotal data readouts in immunology, oncology, hematology, and rare diseases. Management underscored continued investment in R&D as a competitive advantage.

Drivers of Future Performance

Management’s outlook for the year centers on pipeline execution and regulatory milestones, with near-term uncertainty in its retinal business due to market forces and reimbursement dynamics.

• Pipeline Data and Approvals: The company expects pivotal data from trials in immunology, oncology, and rare diseases, which could drive new approvals and label expansions. Management believes that progress on these fronts will be crucial for future revenue and profit growth.
• Market Access and Funding Risks: Ongoing challenges with patient assistance funding and increased use of off-label therapies in retinal disease remain key headwinds. Management is working on initiatives to encourage broader philanthropic support but noted that the timing of resolution is uncertain.
• Manufacturing and Regulatory Execution: Upcoming regulatory decisions—including on the EYLEA HD pre-filled syringe and label expansions—will be important, as will Regeneron’s continued investment in U.S. manufacturing capacity to support long-term growth.

Top Analyst Questions

• Tyler Van Buren (TD Cowen): Asked about the FDA’s complete response letter for EYLEA HD’s pre-filled syringe and the expected timeline for resolution. CEO Leonard Schleifer explained the issue related to a third-party supplier and could resolve quickly or take longer, depending on the FDA’s review process.
• Alexandria Hammond (Wolfe Research): Inquired about prioritization and timing of indications for the Factor XI antibody program. Dr. George Yancopoulos noted that some indications may have earlier launches and emphasized a focus on differentiating efficacy and bleeding risk profiles.
• Chris Schott (JPMorgan): Sought clarity on when copay assistance foundations may reopen and the potential impact on branded anti-VEGF therapy volumes. Schleifer discussed Regeneron’s matching program initiative and the company’s efforts to stimulate broader philanthropic participation.
• Carter Gould (Cantor): Questioned the frequency of regulatory setbacks and whether internal processes would change. Schleifer accepted responsibility but attributed most recent delays to increased FDA scrutiny of contract manufacturers and industry-wide challenges.
• William Pickering (Bernstein): Asked about the sufficiency of data in the EYLEA HD monthly dosing submission. Schleifer confirmed the FDA’s acceptance for review, indicating that data requirements were met, though the final outcome remains to be determined.

Catalysts in Upcoming Quarters

Looking ahead, the StockStory team will monitor (1) the resolution and timing of the EYLEA HD pre-filled syringe regulatory process, (2) pivotal data readouts and regulatory decisions for key pipeline products such as linvoseltamab, odronextamab, and Dupixent in new indications, and (3) trends in anti-VEGF market share as patient assistance funding and reimbursement dynamics evolve. Execution of ongoing R&D investments and expansion of manufacturing capacity will also be critical signposts for Regeneron’s future trajectory.

Regeneron currently trades at a forward P/E ratio of 14.4×. Should you load up, cash out, or stay put? See for yourself in our free research report.

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