Regeneron(REGN) - 2025 Q1 - Quarterly Report

Financial Performance - Regeneron reported revenues of $3,028.7 million for the three months ended March 31, 2025, a decrease of 3.7$3,145.0 million in the same period of 2024[82]. - Net income for the same period was $808.7 million, representing an increase of 12.0$722.0 million in the prior year[82]. - Diluted net income per share increased to $7.27, up 16.0$6.27 in the previous year[82]. - Total revenues decreased to $3,028.7 million in Q1 2025 from$3,145.0 million in Q1 2024, representing a decline of 3.7%[116]. - Net income for the three months ended March 31, 2025, was $808.7 million, an increase of 11.9$722.0 million in the same period of 2024[115]. - Total operating expenses rose to $2,437.0 million in Q1 2025, a slight increase of 1.8$2,393.6 million in Q1 2024[127]. - Cash flows provided by operating activities decreased by $467.4 million, totaling$1,045.1 million for the three months ended March 31, 2025, compared to $1,512.5 million in 2024[142]. - Cash flows provided by investing activities increased by$2,334.6 million, totaling $647.5 million for the three months ended March 31, 2025, compared to$(1,687.1) million in 2024[142]. - As of March 31, 2025, cash and cash equivalents increased to $3,090.2 million, up by$602.0 million from $2,488.2 million at the end of 2024[141]. - The effective tax rate for the three months ended March 31, 2025, was 10.6$1,900.6 million, a decrease of 16% compared to $2,251.0 million in the previous year[90]. - Dupixent generated net product sales of$3,665.6 million, reflecting a 19% increase from $3,076.8 million in the prior year[90]. - Libtayo reported net product sales of$285.1 million, an 8% increase from $263.9 million year-over-year[90]. - Kevzara's net product sales increased by 24$116.4 million, compared to $94.1 million in the previous year[90]. - Other products saw a 24$54.6 million, up from $44.2 million[90]. - Net product sales of EYLEA HD in the U.S. increased to$306.8 million, up 53.4% from $200.0 million in Q1 2024[116]. - Collaboration revenue from Sanofi increased to$1,183.2 million in Q1 2025, up 30.0% from $909.8 million in Q1 2024[121]. - Regeneron's share of profits from Dupixent and Kevzara increased to$1,018.2 million, up 26.7% from $804.0 million in Q1 2024[122]. Research and Development - The company continues to focus on developing treatments for serious diseases, including eye diseases, cancer, and rare diseases, leveraging proprietary technologies[80][81]. - The company is actively engaged in research and clinical programs, with a focus on achieving anticipated development milestones[82]. - Research and development expenses increased to$1,327.4 million in Q1 2025, up 6.3% from $1,248.4 million in Q1 2024[127]. - Total direct research and development expenses for the three months ended March 31, 2025, were$1,327.4 million, an increase of $79.0 million compared to$1,248.4 million in 2024[130]. - Indirect research and development expenses increased to $666.0 million for the three months ended March 31, 2025, up from$609.4 million in 2024, reflecting a $56.6 million increase[130]. - The company expects to continue incurring substantial expenses related to research and development and commercialization of products[114]. Regulatory and Clinical Developments - The company is advancing EYLEA HD in clinical development with a target FDA decision date for the pre-filled syringe on August 19, 2025[94]. - Dupixent is undergoing regulatory review for multiple indications, with a target FDA decision date of June 20, 2025, for chronic spontaneous urticaria (CSU) in adults and adolescents[95]. - The company plans to report results from Phase 3 trials for Itepekimab in COPD by mid-2025[95]. - Libtayo is in Phase 3 studies for various oncology indications, with positive interim data reported for adjuvant CSCC[95]. - The company is initiating a Phase 2 study for Fianlimab in combination with Libtayo for first-line metastatic head and neck squamous cell carcinoma in 2025[95]. - An interim analysis of two ongoing Phase 2/3 studies for fianlimab in first-line advanced NSCLC showed no new safety signals, with further analyses expected in Q1 2026[103]. - The FDA issued a Complete Response Letter (CRL) regarding the sBLA for EYLEA HD, indicating that data did not support extended dosing intervals greater than every 16 weeks[101]. - The FDA also issued a CRL for the EYLEA HD pre-filled syringe, with no issues identified regarding safety, efficacy, or usability[102]. Collaborations and Partnerships - Regeneron collaborates with Bayer and Sanofi for the development and commercialization of certain products, impacting revenue sharing and market reach[88]. - The collaboration with Sanofi involves the company reimbursing 30$1.453 billion as of March 31, 2025[104]. - The company co-commercializes Dupixent in the U.S. and shares profits on a sliding scale with Sanofi, starting at 65% (Sanofi) and ending at 55% (Sanofi)[105]. - The collaboration with Bayer for EYLEA involves shared development expenses and equal profit sharing from sales outside the U.S.[106]. - The company is obligated to reimburse Bayer for 50% of development costs incurred under their agreement, with reimbursement payments capped at 5% of the outstanding obligation[107]. - The collaboration with Alnylam focuses on discovering and developing RNAi therapeutics for various diseases, with an initial discovery period extended to seven years[108]. Manufacturing and Supply Chain - The company is committed to maintaining strong manufacturing and supply chain capabilities to support its product portfolio[79].