Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q4 2024 Earnings Presentation
41 slides from Regeneron Pharmaceuticals's earnings presentation, Feb 4, 2025
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation F E B R U A R Y 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 ~40 product candidates — Includes near-term opportunities with potential to address
Slide 4: Continued execution driving strong results
Continued execution Notable R&D Pipeline Advancements driving strong results • Regulatory application for pre-filled syringe submitted to FDA with decision and launch expected mid-2025 • Positive Phase 3 results in QUASAR study in RVO; sBLA submission planned in Q1 2025 • sBLA submission for every-f
Slide 5: EYLEA HD + EYLEA U.S. net sales were ~$6 billion in 2024, up 1%
EYLEA HD + EYLEA U.S. net sales were ~$6 billion in 2024, up 1% EYLEA HD + EYLEA remained the U.S. anti-VEGF category leader in 2024 U.S. Net Product Sales, in $ Millions Goal to establish EYLEA HD as new standard of care for retinal diseases $166 $1,201 • Q4 2024 U.S. net product sales of $305M • F
Slide 6: Strengthening EYLEA HD product profile in 2025
Strengthening EYLEA HD product profile in 2025 Delivering key enhancements to EYLEA HD product offering to further unlock ongoing launch • Best-in-class efficacy and durability profile provide potential to become the new standard-of-care for retinal diseases • Safety profile consistent with the esta
Slide 7: Dupixent: >1 million patients on therapy globally
Continued growth and expansion in multiple Type 2 indications 2024 Dupixent global net sales of $14.1B (+22% YoY) >1 million patients on therapy globally Dupixent global net product sales, in $ Millions Approved in SEVEN indications globally $3,749 $2,733 Chronic spontaneous urticaria sBLA resubmitt
Slide 8: 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 • Potential to address ~300,000 patients in the U.S. Dupixent Coverage for COPD as of Jan 1, 2025 % Pharma
Slide 9: Full reimbursement of Sanofi development balance anticipated in 2026
Full reimbursement of Sanofi development balance anticipated in 2026 to drive significant increase in collaboration revenue and cash flow Anticipate balance to be fully reimbursed by the end of 2026 • The ‘development balance’ represents development costs funded by Sanofi under the companies’ antibo
Slide 10: 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 11: 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, • WW net sales $1.2B in 2024 (+40% YoY) in $ Millions • Expanding global commerci
Slide 12: 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 13: Dupixent & itepekimab: Two opportunities to address 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, regardless
Slide 14: Itepekimab (IL-33): next innovation in COPD
Itepekimab (IL-33): Regeneron’s next innovation in COPD with pivotal results anticipated in 2H 2025 Building upon Dupixent’s clinical success, potential for benefit in broader COPD population Our RGC found that IL-33 is genetically linked to Phase 2 study showed overall reduction in COPD and asthma
Slide 15: 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 16: 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, ✓ REGN has clinically validated the several with potentially best-in-class clinical efficacy first 3 classes ✓ Can be used acros
Slide 17: 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 18: 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 19: Advancing Fianlimab & LIBTAYO combination across solid tumor cancers
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 20: 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 expected in 2025
Slide 21: Regeneron's differentiated CD3 bispecifics
ORDSPONO LINVOSELTAMAB Regeneron’s (odronextamab, CD20xCD3) (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/refractory (R/R)
Slide 22: Broad odronextamab phase 3 program currently enrolling patients
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 23: Recent data from safety lead-in portion of Ph3 OLYMPIA-1 Trial
Recent data from safety lead-in portion of Ph3 OLYMPIA-1 Trial ASH 2024 UPDATE Odronextamab monotherapy: 12 of 12 complete responses in 1L FL Unprecedented ORR in late-line setting provides confidence for monotherapy approach in earlier lines; Phase 3 OLYMPIA-1 trial designed to explore novel, chemo
Slide 24: Broad linvoseltamab development program in earlier stages of disease
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 25: Linvoseltamab emerging with differentiated clinical 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 26: 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 in 2025: REGN7508 (catalytic domain) and REGN9933 (A2 domain) Future vision: Factor XI Ab’s Mechanism of Action • More specific inh
Slide 27: 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 28: 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 29: 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 30: 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 31: 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 32: 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 33: 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 reated Untreated 0 Potentially first-in-class, one-tim
Slide 34: Regeneron Genetic Medicines pipeline
Regeneron Genetic Medicines pipeline Select Pre-IND Candidates Phase 1 Phase 2 Phase 3 CIDEB* SNCA* ALN-SOD* ALN-PNP* Rapirosiran* Pozelimab + Cemdisiran* CIDEB siRNA SNCA (synuclein) SOD1 siRNA PNPLA3 siRNA HSD17B13 C5 Antibody + C5 siRNA MASH siRNA SOD1 ALS NAFLD siRNA Myasthenia Gravis; Paroxysma
Slide 35: 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 36: Differentiated pipeline opportunities in categories exceeding $220 billion
Differentiated pipeline opportunities to potentially address categories expected to exceed $220 billion annually in 2030 Anticipated Category Product Indication(s) Value Proposition Launch Year COPD with Type 2 First and only biologic approved for Eosinophilic COPD Dupixent 2024 inflammation eosinop
Slide 37: 2025 key upcoming milestones
2025 key upcoming milestones EYLEA HD Solid Organ Oncology • RVO sBLA acceptance (1H) and FDA decision (2H) • Submit sBLA for Libtayo in adjuvant CSCC (1H) • Pre-filled syringe FDA decision and launch (mid) • Report results from Phase 3 study of fianlimab + cemiplimab vs. pembrolizumab • Addition of
Slide 38: 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 and capital expenditures to commercial opportunities
Slide 39: 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 to medicine and fair pricing • Patient advocacy Three responsibility focus areas reflect 2 Foster a culture of int
Slide 40: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations 40
Slide 41: Abbreviations and Definitions
Abbreviations and Definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L First line DOAC Direct oral anticoagulants HR Hazard Ratio Programmed cell death DR Diabetic retinopathy HTT Huntingtin PD-1/PD-(L)1 protein/(ligand) 1 AAV Adeno-associate
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