Regeneron(REGN) - 2025 Q4 - Annual Results

Financial Performance - Regeneron reported Q4 2025 U.S. net sales of $1.1 billion, reflecting a year-over-year growth of 27%[6] - EYLEA HD and EYLEA global net sales reached $4.9 billion in the U.S. branded anti-VEGF category, maintaining a strong market position[6] - Dupixent global net sales increased to $754 million in Q4 2025, with a 27% year-over-year growth[6] - Capital returned to shareholders in 2025 totaled $3.8 billion, including $3.4 billion in share repurchases and $0.4 billion in dividends[6] - Approximately $1.5 billion remains under the current share repurchase program as of December 31, 2025[6] Research and Development - The company has 45 clinical programs across six core therapeutic areas, providing a robust foundation for future growth[4] - The company has internally discovered 14 therapies that have been approved, indicating strong R&D productivity[4] - Regeneron is leveraging the world's largest DNA and proteomics-linked healthcare database to enhance drug discovery and development[4] - The company is a leader in human antibodies and is pioneering bispecifics, siRNA, gene editing, and AAV gene therapy[4] - Estimated Non-GAAP R&D expense for 2026 is projected to be approximately $6.5 billion, with formal financial guidance to be provided at Q4 2025 earnings[6] - The internal R&D spend is aligned with the biopharma industry average of 43% of commercial cash flow, while external business development spend is at 27%[8] Market Opportunities - The global market opportunity across key therapeutic categories is projected to exceed $200 billion annually by 2030[9] - The estimated worldwide market sales for Geographic Atrophy in 2025 is approximately $1.1 billion, with a CAGR of about 34% from 2025 to 2030[15] - The U.S. treatment landscape shows approximately 30,000 patients in 1L (NDMM) and 17,000 patients in 2L, indicating significant market potential[14] Clinical Trials and Approvals - Positive Phase 3 results were demonstrated in allergy programs for cat (FelD1) and birch (BetV1) allergies, with registration-enabling studies set to begin in 2026[11] - The company is advancing a long-acting, fully-human IL-13 & IL-4 antibodies development plan, with first-in-human trials expected in 1H 2026[11] - The company anticipates pivotal data from the 1L metastatic melanoma trial for FIANLIMAB + LIBTAYO in 1H 2026, aiming to transform treatment paradigms[12] - Cemdisiran monotherapy reported the best MG-ADL improvement among C5 inhibitors, with FDA submission planned for Q1 2026 and decision expected by Q4 2026/Q1 2027[15] - The company is conducting 4 registrational studies for Lynozyfic, with 100% of evaluable patients achieving MRD-negativity in HRSMM and 1L multiple myeloma[14] - The anticipated pivotal data for the combination approach in PNH is expected in Q4 2026/Q1 2027[12] - The company is on track for FDA submission for gMG in Q1 2026, with pivotal data expected in Q4 2026/Q1 2027[12] - Regeneron is initiating trials for its investigational drug candidates in the anticoagulation market, with data expected in 2029 for one trial and 2028 for another[16] - Initiated additional Phase 3 trials in multiple myeloma and precursor conditions expected in 2026[19] - Reported results from Phase 3 trial in PNH anticipated in Q4 2026/Q1 2027[19] - Reported initial Phase 2 data in advanced NSCLC expected in 2026[19] - Initiated clinical program for atopic dermatitis with NDA submission for gMG in Q1 2026[19] - FDA decision for genetic hearing loss expected in 2026[19] - Reported interim results from lead-in cohort of Phase 3 trial in GA expected in 2026[19] - Initiated Phase 3 program in obesity with and without T2D expected in 2026[19] - Reported additional data from proof-of-concept data of combination of semaglutide and trevogrumab in obesity expected in 2026[19] - FDA decision for BP expected in Q1 2026[19] - Initiated clinical program for olatopratide and pralutamide expected in 2026[19] Strategic Focus - Regeneron expects to continue delivering growth through leadership in key therapeutic categories[6] - The company is focused on integrating genetics, proteomics, and big data to maintain competitive advantages in the market[4] - The company is prioritizing a combination approach with Praluent (PCSK9) to achieve over 50% LDL lowering along with weight loss[12] - Regeneron aims to achieve over 50% LDL lowering in combination therapies, which will be administered via weekly injections[17] - The anticoagulation market remains underpenetrated, with less than 50% of eligible patients receiving therapy due to safety concerns[16] - Regeneron is exploring preclinical solutions for muscle preservation in obesity treatment[17] Financial Commitments - $6 billion is committed to U.S. manufacturing and R&D infrastructure expansion over the coming years[6]