Regeneron’s first quarter was marked by a negative market reaction, as revenue and non-GAAP earnings fell short of Wall Street’s expectations. The primary driver of underperformance was a steep revenue decline in the company’s retinal franchise, particularly EYLEA, which management attributed to increased competition from low-cost alternatives and reduced patient affordability due to a funding gap at co-pay assistance foundations. CEO Leonard Schleifer described the quarter as “mixed,” noting that while EYLEA HD showed some resilience, the broader branded anti-VEGF category contracted. Management also acknowledged regulatory setbacks, including a delay in the approval of the EYLEA HD pre-filled syringe.
Is now the time to buy REGN? Find out in our full research report (it’s free).
Regeneron (REGN) Q1 CY2025 Highlights:
- Revenue: $3.03 billion vs analyst estimates of $3.23 billion (3.7% year-on-year decline, 6.1% miss)
- Adjusted EPS: $8.22 vs analyst expectations of $8.48 (3% miss)
- Operating Margin: 19.5%, down from 23.9% in the same quarter last year
- Market Capitalization: $53.86 billion
While we enjoy listening to the management's commentary, our favorite part of earnings calls are the analyst questions. Those are unscripted and can often highlight topics that management teams would rather avoid or topics where the answer is complicated. Here is what has caught our attention.
Our Top 5 Analyst Questions Regeneron’s Q1 Earnings Call
- Tyler Van Buren (TD Cowen) asked about the timeline and specifics behind the EYLEA HD pre-filled syringe regulatory delay. CEO Leonard Schleifer explained the delay was due to FDA questions for a third-party supplier and emphasized efforts to resolve the issue quickly, though the timeline remains uncertain.
- Alexandria Hammond (Wolfe Research) sought clarity on prioritization and timing for Factor XI antibody indications. Chief Scientific Officer George Yancopoulos stated the company is targeting both broad and niche indications, aiming for a balance between rapid approval and demonstrating differentiated bleeding risk benefits.
- Chris Schott (JPMorgan) inquired about the potential reopening of co-pay assistance foundations and its impact on EYLEA volumes. Schleifer detailed the challenges in funding and efforts to introduce a matching program to encourage broader industry and philanthropic participation.
- Carter Gould (Cantor) questioned Regeneron’s regulatory track record following recent complete response letters (CRLs) and delays. Schleifer accepted responsibility, attributed most CRLs to third-party supplier issues, and pointed to increased FDA scrutiny post-COVID rather than systemic internal failings.
- William Pickering (Bernstein) asked about the sufficiency of safety data in the EYLEA HD monthly dosing submission. Schleifer declined to disclose specifics but confirmed the FDA had accepted the submission for review, indicating it met initial requirements.
Catalysts in Upcoming Quarters
In upcoming quarters, the StockStory team will be closely watching (1) the resolution and regulatory progress for EYLEA HD, particularly regarding pre-filled syringe and new dosing approvals; (2) the commercial uptake and payer coverage for new Dupixent indications, especially in COPD and CSU; and (3) pivotal clinical data and regulatory outcomes for late-stage pipeline assets in oncology and rare diseases. Additional attention will be given to developments in patient assistance funding and updates on large-scale manufacturing investments.
Regeneron currently trades at $511.25, down from $610.36 just before the earnings. In the wake of this quarter, is it a buy or sell? The answer lies in our full research report (it’s free).
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