Regeneron Provides Business Updates and Highlights from Broad Clinical Pipeline at the 43rd Annual J.P. Morgan Healthcare Conference

Dupixent Updates - Dupixent is now used to treat over a million patients globally, with continued growth in multiple indications for diseases involving type 2 inflammation [1][3] - The recent approval and launch in chronic obstructive pulmonary disease (COPD) has secured coverage from top commercial and Medicare payers, addressing approximately 300,000 patients in the US [3] - Continued growth potential exists in additional indications, including chronic spontaneous urticaria (CSU) with an FDA decision expected by April 18, 2025, and bullous pemphigoid, for which a supplemental Biologics License Application (sBLA) was submitted in Q4 2024 [3] EYLEA and EYLEA HD Updates - EYLEA HD and EYLEA remained the US anti-VEGF category leader in 2024, with aggregate US net product sales of $6 billion, up 1$1.5 billion, with EYLEA HD contributing $305 million and EYLEA contributing$1.19 billion [40][45] - The company filed an application with the FDA for the EYLEA HD pre-filled syringe (PFS), with approval and launch expected by mid-2025 [1][12] Libtayo Updates - Libtayo exceeded $1 billion in annual net sales for 2024, becoming the first and only immunotherapy to show a statistically significant clinical benefit as adjuvant therapy in high-risk cutaneous squamous cell carcinoma (CSCC) [1][12] - A Phase 3 study demonstrated a 68$220 billion by 2030 [12] - Key pipeline candidates include itepekimab (IL-33) for COPD, fianlimab (LAG3) for melanoma, linvoseltamab (BCMAxCD3) for multiple myeloma, and odronextamab (CD20xCD3) for lymphoma [12] Genetics and Data-Driven Innovation - The Regeneron Genetics Center has sequenced nearly three million people with de-identified linked healthcare records [6] - A strategic collaboration with Truveta, Inc is expected to expand the DNA-linked healthcare database to include sequencing and linked Electronic Health Records for up to 10 million additional individuals [6] - The company was selected by UK BioBank consortium members to complete proteomic assay data generation for the UK Biobank Pharma Proteomics Project [6]