Regeneron Pharmaceuticals, Inc.

EYLEA and EYLEA HD Performance Decline: Regeneron's EYLEA U.S. net sales fell 39% year-over-year to $736 million due to increased competition from low-cost off-label repackaged Avastin and a gap in co-pay assistance for patients. Physician unit demand decreased 14% sequentially, with combined sales of EYLEA and EYLEA HD at $1.04 billion (down 30% sequentially). EYLEA HD showed growth of 54% YoY, with $307 million in sales, indicating some resilience in this product.

Regulatory Challenges with EYLEA HD: The FDA issued a complete response letter (CRL) for the EYLEA HD pre-filled syringe, citing a key issue related to a third-party component supplier without affecting the safety or efficacy of the product. While there's potential for a resolution, the exact timeline is uncertain, which poses a risk to EYLEA HD's future.

Dupixent Growth Outlook: Dupixent achieved first-quarter 2025 net sales of $3.7 billion, reflecting a 20% increase year-over-year. It retains its leadership across all approved indications in the U.S. and is expected to grow further, particularly with upcoming approvals for bullous pemphigoid and the recent approval for chronic spontaneous urticaria, reinforcing its position as a cornerstone treatment in multiple therapeutic areas.