Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q2 2025 Earnings Presentation
37 slides from Regeneron Pharmaceuticals's earnings presentation, Aug 1, 2025
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation A U G U S T 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 t
Slide 4: Q2 2025 Financial Performance and Pipeline Developments
Q2 2025 Financial Notable R&D Pipeline Advancements Performance and Pipeline Developments • Extended dosing intervals up to Q24W approved in EC • Approved for BP in the U.S.; regulatory applications under review in EU and Japan • Approved in the U.S. for CSU patients who remain symptomatic despite a
Slide 5: Dupixent: continued growth and expansion in multiple indications
Continued growth and expansion in multiple Type 2 indications 2Q 2025 Dupixent global net sales of $4.3B (+21% YoY*) Dupixent global net product sales, ~1.2 million patients on therapy globally in $ Millions +21%* Approved in EIGHT indications globally $1,140 $993 $952 $946 $1,036 Chronic spontaneou
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 inflammatory diseases Atopic Dermatitis Asthma Atopic Dermatitis CRSwNP Atopic Dermatitis Adults 18+ Adults/Adolescents 12+ Adolesce
Slide 9: EYLEA HD + EYLEA in the U.S.
EYLEA HD + EYLEA in the U.S. EYLEA HD + EYLEA remain the U.S. branded anti-VEGF category leader Goal to establish EYLEA HD as new standard of care for retinal diseases U.S. Net Product Sales, in $ Millions • Q2 2025 U.S. net product sales of $393M comprised 34% of Q2 2025 aggregate EYLEA + EYLEA HD
Slide 10: Libtayo: 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 • Q2 2025 WW net sales of $377M (+25% YoY*) Libtayo global net product sales, • U.S. net sales of $248M (+36% YoY),
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 Phase 3 data for itepekimab in former smokers with COPD (1 of & Immunology 2 studies met primary endpoint) Oncology • Phase 3 data for fianlim
Slide 12: Addressing high unmet need in COPD
Addressing high unmet need in COPD Itepekimab† (anti IL-33) Type 2 Non-Type 2 • Addressing COPD with an • AERIFY program results reported in (70% of COPD patients) Former Smokers eosinophilic phenotype (eos ≥300/μl) May 2025 in both current and former smokers Dupixent or Itepekimab itepekimab only •
Slide 13: 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 14: 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 15: 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 16: Fianlimab & LIBTAYO in 1L metastatic melanoma
Combining two potentially best-in-class checkpoint inhibitors: Fianlimab (anti-LAG-3) & LIBTAYO (anti-PD-1) 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
Slide 17: Advancing Fianlimab & LIBTAYO combination across solid tumor cancers
Advancing Fianlimab (anti-LAG-3) & LIBTAYO (anti-PD-1) 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. curre
Slide 18: 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 Cemiplimab PSMAxCD3 Prostate Cancer; Data poster at AACR and combination co
Slide 19: Regeneron's differentiated CD3 bispecifics
Regeneron’s ORDSPONO differentiated (odronextamab, CD20xCD3) (linvoseltamab, BCMAxCD3) CD3 bispecifics Multiple myeloma (MM) Non-Hodgkin lymphoma (NHL) Regeneron’s first approved bispecific antibody (in EU) in Lynozyfic is a BCMAxCD3 bispecific relapsed/refractory (R/R) follicular with a differentia
Slide 20: Lynozyfic differentiated clinical profile in r/r multiple myeloma
Within the BCMA bispecific class, Lynozyfic provides a 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 conclus
Slide 21: Broad Lynozyfic development program in earlier stages of disease
Broad Lynozyfic 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 therapy U
Slide 22: Broad Ordspono phase 3 program currently enrolling patients
Broad Ordspono 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 Phase 3
Slide 23: Two-pronged approach to anticoagulation
Two-pronged approach to anticoagulation offers potential for improved blood clot prevention and lower bleeding risk Two Factor XI antibodies advancing to pivotal trials: REGN7508 (catalytic domain) and REGN9933 (A2 domain) Future vision: Factor XI Ab’s Mechanism of Action • More specific inhibition
Slide 24: Regeneron's 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 25: Differentiated 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 26: Semaglutide with muscle-preserving antibodies in Phase 2 COURAGE study
Combining semaglutide with muscle-preserving antibodies improved the quality of weight loss in Phase 2 COURAGE study At interim analysis of Phase 2 COURAGE study, ~35% of semaglutide weight loss was due to lean mass loss, confirming that up to 40% of weight loss from semaglutide is due to decrease i
Slide 27: Transforming patient care for obesity and related conditions
Transforming patient care for obesity and related conditions Three major opportunities for Regeneron in the rapidly growing obesity therapeutic area: 1 2 3 GLP1/GIP Receptor Agonist Enhancing the quality of GLP1- Address obesity comorbidities monotherapy based weight loss with novel combinations Ola
Slide 28: 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 29: DB-OTO demonstrates 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 reated ntreated Potentially first-in-class, one-time t
Slide 30: 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 31: 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) REGN7257 (IL-2Rγ) (anti-C5 + C5 siRNA) REGN7945 (CD38xCD28) REGN7999 (TMPRSS6) od
Slide 32: Differentiated pipeline opportunities addressing categories exceeding $220 billion in 2030
Differentiated pipeline opportunities to potentially address categories expected to exceed $220 billion annually in 2030 Category Product Indication(s) Value Proposition Eosinophilic COPD Dupixent Eosinophilic COPD First biologic approved for eosinophilic COPD COPD in Potential first-in class opport
Slide 33: 2025 key upcoming milestones
2025 key upcoming milestones EYLEA HD Solid Organ Oncology • RVO sBLA acceptance ✓; FDA decision • Submit sBLA for Libtayo in adjuvant CSCC (PDUFA October 2025) ✓ • Pre-filled syringe FDA decision and launch • Report results from Phase 3 study of fianlimab + cemiplimab vs. pembrolizumab • Addition o
Slide 34: Continuing to deliver on capital allocation priorities
Continuing to deliver on capital allocation priorities to drive long-term growth Internal Business Return Capital to Investment Development Shareholders in our world-class R&D capabilities to expand pipeline and maximize with share repurchases and capital expenditures to commercial opportunities and
Slide 35: Three responsibility focus areas reflect our "doing well by doing good"
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 Foster a culture of integrity and ex
Slide 36: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations 36
Slide 37: Abbreviations and Definitions
Abbreviations and Definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L First line DOAC Direct oral anticoagulants HNSCC Head and neck squamous ORR Overall Response Rate American Association for Cancer DR Diabetic retinopathy HR Hazard Ratio P
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