Regeneron Faces Setbacks as Eylea Sales Decline and FDA Rejects Prefilled Syringe

Regeneron Pharmaceuticals experienced a challenging first quarter, with its shares tumbling 7% in pre-market trading on Tuesday following disappointing earnings and a regulatory setback for its blockbuster eye medication, Eylea.

Q1 Earnings Miss and Eylea Sales Decline

Regeneron reported first-quarter earnings of $3 billion, falling short of expectations on both top and bottom lines, according to BMO Capital Markets. The company's flagship product, Eylea, a retinal disease therapy, saw a significant decline in sales. Total U.S. sales for Eylea reached $1.05 billion for the quarter, marking a 26% decrease compared to the same period last year.

Several factors contributed to Eylea's underwhelming performance:

• Ongoing funding concerns for patient assistance charities
• Pressure from competing products, including Genentech's Avastin
• Lower net selling price
• Reduced wholesale inventory
• Continued biosimilar competition

FDA Rejection of Eylea Prefilled Syringe

Adding to Regeneron's challenges, the U.S. Food and Drug Administration (FDA) issued a complete response letter rejecting the company's application for a prefilled syringe version of Eylea. This decision creates another near-term obstacle for the company, which had been anticipating approval by mid-2023.

The FDA's rejection apparently stemmed from issues with a third-party component supplier of the syringe, according to BMO Capital Markets. This setback could potentially impact overall sales for the Eylea franchise, as competitors like Roche's Vabysmo have already benefited from having prefilled syringe versions available in the market.

Market Reaction and Future Outlook

In response to these developments, Regeneron's shares fell to $568 in pre-market trading on Tuesday, down from $610.86 at Monday's close. BMO Capital Markets now anticipates a "messy quarter" as Regeneron attempts to mitigate losses in its key Eylea franchise.

As the company navigates these challenges, industry observers will be closely monitoring Regeneron's strategies to maintain its market position and address the issues surrounding Eylea's sales decline and regulatory hurdles.