Regeneron crumples under the weight of missed Eylea expectations

Title

Regeneron Stock Drops as Eylea Sales Disappoint and FDA Setbacks Compound Pressure

Keywords

• Regeneron Pharmaceuticals
• Eylea sales decline
• FDA rejection
• Q1 2025 earnings miss
• Ophthalmology drugs
• Biosimilar competition
• Eylea HD
• Prefilled syringe
• Retinal disease treatment
• Stock market reaction

Key Facts

• Regeneron reported a sharp sales decline for its Eylea eye disease portfolio in Q1 2025, missing analyst expectations and leading to significant pressure on its financial results24.
• The Eylea franchise, including both standard and high-dose (HD) formulations, saw overall sales fall 26% compared to the same period in 2024, totaling $1.04 billion in the quarter14.
• Standard Eylea’s U.S. sales dropped 39% in Q1 to $736 million—nearly $100 million below Wall Street consensus estimates1.
• While Eylea HD saw U.S. sales grow 54% year-over-year to $307 million, this growth could not counteract the overall decline in the franchise1.
• Regeneron's Q1 2025 earnings missed both top and bottom line expectations, with total reported earnings of $3 billion4.
• Shares of Regeneron fell approximately 7% in pre-market trading following the earnings announcement and missed expectations4.
• Additional setbacks included the FDA’s rejection of a prefilled syringe version of Eylea, which was expected to help compete against rivals offering similar options. The agency's concerns reportedly related to a third-party component supplier4.
• External pressures—such as competition from Genentech’s Avastin, biosimilar entrants like Amgen’s Pavblu, lower net selling prices, and declining wholesale inventory—further exacerbated Eylea’s performance issues45.
• Regeneron recently lost a court appeal to block Amgen’s Eylea biosimilar from the U.S. market, adding to the risk profile for the flagship franchise5.
• CEO Leonard Schleifer characterized the company’s Q1 performance as “mixed,” acknowledging multiple ongoing challenges1.

Sources:

1. https://www.fiercepharma.com/pharma/regenerons-eylea-hd-suffers-double-whammy-poor-sales-and-second-surprise-fda-rejection

2. https://seekingalpha.com/news/4436882-regeneron-stock-drops-eylea-drives-q1-miss

4. https://www.biospace.com/business/regeneron-shares-tumble-as-eylea-declines-make-for-a-messy-quarter-to-come

5. https://www.biospace.com/drug-development/opthea-unity-fail-to-unseat-regenerons-eylea-in-vision-disorders