Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q1 2025 Earnings Presentation
39 slides from Regeneron Pharmaceuticals's earnings presentation, Apr 29, 2025
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation A P R I L 2 0 2 5 This non-promotional presentation contains investigational data as well as forward-looking statements; actual results may vary materially.
Slide 2: Note regarding forward-looking statements and non-GAAP financial measures
Note regarding forward-looking statements and non-GAAP financial measures This presentation includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual even
Slide 3: Driven by science and innovation
Differentiated technology platforms have delivered 4 ‘blockbuster’ products discovered by Regeneron Driven by science and innovation Unprecedented research and discovery capabilities drive best- in-class pipeline of ~45 product candidates — Includes near-term opportunities with potential to address
Slide 4: Q1 2025 Financial Performance and Pipeline Developments
Q1 2025 Financial Notable R&D Pipeline Advancements Performance and Pipeline Developments • sBLA submission accepted for RVO and every four-week dosing (PDUFA Aug 19) • Approved in CSU in U.S. and in COPD in Japan • sBLA for BP accepted (PDUFA June 20), late-breaking data presented at American Acade
Slide 5: Continued growth and expansion in multiple Type 2 indications
Continued growth and expansion in multiple Type 2 indications 1Q 2025 Dupixent global net sales of $3.7B (+20% YoY*) ~1.2 million patients on therapy globally Dupixent global net product sales, in $ Millions Approved in SEVEN indications globally +20%* Chronic spontaneous urticaria (CSU) approved in
Slide 6: COPD launch underway in U.S.
COPD launch underway in U.S. Dupixent approved by FDA in late September 2024 as an add-on maintenance treatment of adult patients with inadequately controlled COPD and an eosinophilic phenotype Dupixent Cumulative NBRx by Indication • Potential to address ~300,000 patients in the U.S. Weekly launch-
Slide 7: Full reimbursement of Sanofi development balance anticipated in 2026
Full reimbursement of Sanofi development balance anticipated in 2026; Expected to drive significant growth in collaboration revenue & cash flow • The ‘development balance’ represents development costs funded by Sanofi under the companies’ antibody collaboration Reimbursement Obligation to Sanofi for
Slide 8: Delivering on Dupixent's "pipeline in a product" potential
Delivering on Dupixent’s “pipeline in a product” potential Dupixent clinical trials have repeatedly demonstrated that IL-4 and IL-13 are key drivers of multiple Type 2 allergic diseases Atopic Dermatitis Asthma Atopic Dermatitis CRSwNP Atopic Dermatitis Adults 18+ Adults/Adolescents 12+ Adolescent 1
Slide 9: EYLEA HD + EYLEA in the U.S.
EYLEA HD + EYLEA in the U.S. EYLEA HD + EYLEA remain the U.S. anti-VEGF category leaders Goal to establish EYLEA HD as new standard of care for retinal diseases U.S. Net Product Sales, in $ Millions • Q1 2025 U.S. net product sales of $307M comprised 29% of Q1 2025 EYLEA + EYLEA HD net sales $304 $3
Slide 10: Key growth driver and foundational to oncology portfolio
Key growth driver and foundational to oncology portfolio LIBTAYO has become Regeneron’s latest internally-discovered drug to reach >$1B in annual net sales Strong and consistent growth Libtayo global net product sales, • Q1 2025 WW net sales of $285M (+8% YoY*) in $ Millions • U.S. net sales of $193
Slide 11: Key 2025 clinical milestones to drive long-term shareholder value
Key 2025 clinical milestones to drive long-term shareholder value Opportunity to address areas of high unmet need in large commercial categories Inflammation • Pivotal Phase 3 data for itepekimab in former smokers & Immunology with COPD Oncology • Pivotal Phase 3 data for fianlimab* in 1L metastatic
Slide 12: Dupixent & itepekimab: Two opportunities to address high unmet need in COPD
† Dupixent & itepekimab : Two opportunities to address high unmet need in COPD Itepekimab Type 2 Non-Type 2 (anti IL-33) (70% of COPD patients) Former Smokers • Addressing COPD with an • Potential to address COPD in eosinophilic phenotype (eos ≥300/μl) Dupixent or Itepekimab former smokers, regardle
Slide 13: Itepekimab (IL-33): next innovation in COPD with pivotal results mid-2025
Itepekimab (IL-33): Regeneron’s next innovation in COPD with pivotal results anticipated in mid-2025 Building upon Dupixent’s clinical success, potential for benefit in broader COPD population The RGC found that IL-33 is genetically linked to Phase 2 study showed overall reduction in COPD and asthma
Slide 14: Novel treatment approach for potentially reversing severe allergy
Novel treatment approach for potentially reversing severe allergy: Linvoseltamab (BCMAxCD3) plus Dupixent (anti-IL4Rα) Linvoseltamab and Dupixent regimen ~90% reduction in IgE levels has the potential to eliminate IgE: in Severe Food-Allergic Patient #1 potential groundbreaking approach Dupixent run
Slide 15: Regeneron's oncology strategy: 5 classes of immunomodulatory agents
Regeneron’s oncology strategy: using the immune system to defeat cancer with 5 classes of immunomodulatory agents Regeneron has clinically validated these first 3 classes, several with potentially best-in-class clinical efficacy Indication areas of focus Hematological T Cell checkpoint Signal 1 Sign
Slide 16: Unique flexibility of internally-developed oncology pipeline
Unique flexibility of internally-developed oncology pipeline drives potential for novel and differentiated combinations Linvoseltamab Linvoseltamab Cemiplimab Cemiplimab (BCMAxCD3) (BCMAxCD3) (PD-1) (PD-1) Fianlimab Cemiplimab Odronextamab Odronextamab Cemiplimab (LAG-3) (PD-1) (CD20xCD3) (CD20xCD3)
Slide 17: Fianlimab & LIBTAYO in 1L metastatic melanoma
Combining two potentially best-in-class checkpoint inhibitors: Fianlimab (anti-Lag3) & LIBTAYO (anti-PD1) in 1L metastatic melanoma* Emerging as potentially differentiated treatment option for 1L metastatic melanoma Table depicts randomized Phase 3 data for four FDA-approved treatments as well as po
Slide 18: Advancing Fianlimab & LIBTAYO combination in melanoma and solid tumors
Advancing Fianlimab (anti-Lag3) & LIBTAYO (anti-PD1) combination in melanoma and across several solid tumor cancers Combining two potentially “best-in-class” checkpoint inhibitors: Fianlimab (anti-LAG-3) & LIBTAYO (cemiplimab, anti-PD-1) – potential for differentiated efficacy and safety vs. current
Slide 19: Pipeline of CD28 costimulatory bispecifics progressing
Pipeline of CD28 costimulatory bispecifics progressing Combined with: Dose Proof-of- Dose Checkpoint xCD3 Escalation Mechanism Expansion Status / Next Steps Inhibitors bispecifics Nezastomig (PSMAxCD28) Enrolling monotherapy and combination Cemiplimab PSMAxCD3 Prostate Cancer; Data poster at AACR co
Slide 20: Regeneron's differentiated CD3 bispecifics
ORDSPONO LYNOZYFIC Regeneron’s (odronextamab, CD20xCD3) (linvoseltamab, BCMAxCD3) differentiated Non-Hodgkin lymphoma (NHL) Multiple myeloma (MM) CD3 bispecifics Regeneron’s first approved bispecific antibody (in EU) in Linvoseltamab has the potential to be the best-in-class BCMAxCD3 relapsed/refrac
Slide 21: Broad odronextamab phase 3 program currently enrolling
Broad odronextamab phase 3 program currently enrolling patients, including in earlier lines of FL and DLBCL Monotherapy efficacy in late lines supports differentiated approach using monotherapy and novel combinations in earlier lines Line of therapy U.S. treated population Study Phase 1 Phase 2 Phas
Slide 22: Broad linvoseltamab development program
Broad linvoseltamab development program to evaluate monotherapy and simplified combinations in earlier stages of disease Unprecedented late-line responses rates provide confidence to explore monotherapy and novel combinations in earlier disease settings to simplify treatment approaches Line of thera
Slide 23: Linvoseltamab differentiated profile in r/r multiple myeloma
Within the BCMA bispecific class, linvoseltamab emerging with differentiated and compelling clinical profile in r/r multiple myeloma There are no randomized, head-to-head clinical trials between these products. Study data being provided for descriptive purposes only. Caution is advised when drawing
Slide 24: Two-pronged approach to anticoagulation with Factor XI antibodies
Two-pronged approach to anticoagulation offers potential for improved blood clot prevention and lower bleeding risk Two Factor XI antibodies advancing to pivotal trials in 2025: REGN7508 (catalytic domain) and REGN9933 (A2 domain) Future vision: Factor XI Ab’s Mechanism of Action • More specific inh
Slide 25: Factor XI antibodies: maximal anti-coagulation with minimal bleeding
Regeneron’s Factor XI antibodies: Potential for maximal anti-coagulation with minimal bleeding Positive proof-of-concept data for REGN7508 (catalytic) and REGN9933 (A2) announced in December 2024 Preclinical aPTT Screening Results of REGN 6.5 Antibodies and Competitor FXI Agents Initiation of Therap
Slide 26: siRNA + antibody approach for complement-mediated diseases
Our differentiated siRNA + antibody approach has the potential to address multiple complement-mediated diseases Despite competitive markets, there is opportunity to improve upon the current standard of care with prolonged and complete inhibition of complement protein C5 (for multiple diseases) siRNA
Slide 27: Regeneron's approach to obesity: novel combinations
Regeneron’s approach to obesity: novel combinations with leading medicines aim to improve quality of weight loss GLP-1 based therapies, such as semaglutide (sema) and tirzepatide, are emerging as standards of care for weight loss; however, up to 40% of weight loss from these agents is due to decreas
Slide 28: Phase 2 COURAGE study in obesity fully enrolled
Phase 2 COURAGE study in obesity fully enrolled; primary analysis expected to read-out in 2H 2025 Phase 2 study to investigate if addition of trevogrumab (anti-myostatin) to semaglutide with and without garetosmab (anti- activin A) improves the quality of weight loss and/or improves maintenance of w
Slide 29: Robust pre-clinical obesity and cardiometabolic pipeline
Leveraging decades of expertise to develop a robust pre-clinical obesity and cardiometabolic pipeline Our first wave of therapeutics focuses Our next wave of therapeutics focuses on on improving GLP1-based weight loss GLP1-independent mechanisms and targeting by preserving muscle muscle growth and i
Slide 30: World-class Regeneron Genetic Medicines (RGM) Program
World-class Regeneron Genetic Medicines (RGM) Program RGM builds and utilizes ‘turnkey’ therapeutic platforms — customizing the choice of genetics technology (siRNA, CRISPR/Cas9, etc.) based on therapeutic application Continuing to build in-house expertise and leverage groundbreaking industry collab
Slide 31: DB-OTO potential to provide hearing to deaf children
DB-OTO demonstrates the potential to provide hearing to deaf children (from infancy to adolescence) DB-OTO is an AAV-based dual-vector gene therapy delivered to the inner ear to enable hearing in children Gene therapy for genetic hearing deficit Treated Untreated Potentially first-in-class, one-time
Slide 32: Regeneron Genetic Medicines pipeline
Regeneron Genetic Medicines pipeline Select Pre-IND Candidates Phase 1 Phase 2 Phase 3 MAPT* SNCA* ALN-SOD* ALN-PNP* Rapirosiran* Pozelimab + Cemdisiran* MAPT (Tau) siRNA SNCA (synuclein) SOD1 siRNA PNPLA3 siRNA HSD17B13 C5 Antibody + C5 siRNA Neuro-degenerative siRNA SOD1 ALS NAFLD siRNA Myasthenia
Slide 33: Regeneron-discovered, approved and investigational medicines
Regeneron-discovered, approved and investigational medicines across a diverse set of diseases Phase 1 Phase 2 Phase 3 Approved † vonsetamig (BCMAxCD3) REGN9933 (Factor XI) pozelimab + cemdisiran‡ ° REGN5837 (CD22xCD28) REGN7508 (Factor XI) (anti-C5 + C5 siRNA) REGN7945 (CD38xCD28) REGN7257 (IL-2Rγ)
Slide 34: Pipeline opportunities in categories exceeding $220 billion annually in 2030
Differentiated pipeline opportunities to potentially address categories expected to exceed $220 billion annually in 2030 Anticipated Category Product Indication(s) Value Proposition Launch Year First and only biologic approved for Eosinophilic COPD Dupixent 2024 Eosinophilic COPD eosinophilic COPD C
Slide 35: 2025 key upcoming milestones
2025 key upcoming milestones EYLEA HD Solid Organ Oncology • RVO sBLA acceptance ✓; FDA decision (PDUFA Aug 19) • Submit sBLA for Libtayo in adjuvant CSCC✓ • Pre-filled syringe FDA decision and launch – CRL received • Report results from Phase 3 study of fianlimab + cemiplimab vs. pembrolizumab • Ad
Slide 36: Continuing to deliver on capital allocation priorities
Continuing to deliver on capital allocation priorities to drive long-term growth Internal Return Capital to Business Shareholders Investment Development with share repurchases and in our world-class R&D capabilities to expand pipeline and maximize dividends and capital expenditures to commercial opp
Slide 37: Three responsibility focus areas reflect our "doing well by doing good" ethos
OUR MISSION Use the power of science to repeatedly bring new medicines to people with serious diseases 1 Improve the lives of people with serious diseases • Pipeline innovation • Access and affordability • Patient advocacy Three responsibility focus areas reflect 2 Foster a culture of integrity and
Slide 38: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations 38
Slide 39: Abbreviations and Definitions
Abbreviations and Definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L First line DFS Disease-Free Survival HR Hazard Ratio Programmed cell death PD-1/PD-(L)1 American Association for Cancer DOAC Direct oral anticoagulants HTT Huntingtin prot
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