Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q4 2023 Earnings Presentation
32 slides from Regeneron Pharmaceuticals's earnings presentation, Feb 2, 2024
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation F E B R U A R Y 2 0 2 4 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: Executing on our core competencies, investing in Regeneron, looking ahead
Executing on our Investing in Looking ahead core competencies Regeneron to the future • Investing ~$5B into R&D • Over 35 therapeutic candidates in various stages of clinical development in 2024* #1 prescribed Now FDA approved • Pioneering novel therapeutic FDA approved anti- aspire to become • Repu
Slide 4: Continued execution driving strong results; notable R&D pipeline advancements
Continued execution Notable R&D Pipeline Advancements driving strong results • EYLEA HD (known as EYLEA 8 mg outside of U.S.) approved in EU and Japan for wAMD and DME • Met primary endpoint at interim analysis of confirmatory Phase 3 NOTUS study in COPD with evidence of type 2 inflammation • Regula
Slide 5: EYLEA HD approved in U.S. for wAMD, DME, and DR
EYLEA HD approved in U.S. for wAMD, DME, and DR 4Q 2023 combined EYLEA HD + EYLEA U.S. net product sales of $1.46 billion FDA approval for wAMD, DME and DR received in August 2023 Early indicators suggest broad initial uptake across treatment landscape has the potential to become the next-generation
Slide 6: Maintaining U.S. anti-VEGF category leadership with Eylea HD launch
Maintaining U.S. anti-VEGF category leadership with Eylea HD launch Building on 12+ years of safety and efficacy experience, breadth of indications, and flexible dosing regimens U.S. Net Product Sales, in $ Billions Q4 2023 combined revenues of $1.46 billion Eylea HD launched in late August 2023 $0.
Slide 7: Dupixent global net product sales grew 34% and reached nearly $11.6 billion in 2023
Dupixent global net product sales grew 34%* and reached nearly $11.6 billion in 2023 In the fourth quarter of 2023, Dupixent global net sales grew 31%* to ~$3.2 billion Incremental market penetration, new indications, and younger populations represent significant opportunity for continued growth >80
Slide 8: Delivering on "pipeline in a product" potential
Delivering on “pipeline in a product” potential Dupixent clinical trials have demonstrated that IL-4 and IL-13 are key drivers of multiple Type 2 allergic diseases Atopic Dermatitis Asthma Atopic Dermatitis CRSwNP Atopic Dermatitis Asthma Adults 18+ Adults/Adolescents 12+ Adolescent 12+ Adults 18+ P
Slide 9: Potential to change the COPD treatment paradigm with Dupixent and itepekimab
Potential to change the COPD treatment paradigm with Dupixent and itepekimab (anti-IL4/13) Itepekimab (anti-IL-33) Positive results in Phase 3 BOREAS and NOTUS studies Positive data in former smokers in Phase 2 COPD study in eosinophilic COPD reported during 2023 informed Phase 3 trial design sBLA s
Slide 10: 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 • Potential to address COPD with a • Potential to address COPD in Type 2 inflammatory phenotype Dupixent or Itepekimab former smokers, regardles
Slide 11: Novel treatment approach for reversing severe allergy
Novel treatment approach for reversing severe allergy: Linvoseltamab (BCMAxCD3) plus Dupixent (anti-IL4Rα) Transient plasma cell depletion with BCMAxCD3 Myeloma patients treated with plus sustained IL-4Rα blockade durably eliminates linvoseltamab rapidly reduce IgE levels1 IgE production in cynomolg
Slide 12: Striving for global leadership in oncology
Striving for global leadership in oncology Potential for up to three FDA-approved products by end of 2024, spanning solid and hematological malignancies 2018 2021 2022 2023 Libtayo FDA- Libtayo FDA-approved as Libtayo + chemotherapy Submitted BLAs for approved as first monotherapy in advanced FDA-ap
Slide 13: Harnessing the immune system to fight cancer
Harnessing the immune system to fight cancer Regeneron has validated 3 independent classes of internally-developed immuno-oncology agents • One approved medicine, two under regulatory review • Robust pipeline of immuno-oncology combinations Checkpoint Inhibitors CD3 Bispecifics CD28 Costimulatory Bi
Slide 14: Unique flexibility of internally-developed pipeline drives novel combinations
Unique flexibility of internally-developed pipeline drives potential for novel and differentiated combinations Bispecifics and Checkpoint Inhibitor Combos Checkpoint Inhibitor Combos Odronextamab Linvoseltamab PSMAxCD3 Ubamatamab Cemiplimab Fianlimab Melanoma & other (CD20xCD3) (BCMAxCD3) (REGN4336)
Slide 15: Libtayo: Key growth driver and oncology portfolio foundation
Libtayo: Key growth driver and oncology portfolio foundation Market leader in advanced cutaneous squamous cell carcinoma and advanced basal cell carcinoma Strong and Consistent Growth • Q4 2023 U.S. net product sales of $155M (+41% YoY) and rest of +43% world sales of $89M (+46%* YoY) Growth vs. 4Q2
Slide 16: Fianlimab (anti-LAG-3) + cemiplimab (anti-PD-1): Combining two checkpoint inhibitors
Fianlimab (anti-LAG-3) + cemiplimab (anti-PD-1): Combining two checkpoint inhibitors Results from three independent 1L metastatic melanoma cohorts from the FIH study demonstrated strong efficacy signal, including in patients treated with adjuvant anti-PD-1 therapy Phase 1 Phase 2 Phase 3 Results in
Slide 17: Regeneron's leading CD3 bispecifics
Regeneron’s Linvoseltamab (BCMAxCD3) – MM leading CD3 Linvoseltamab has the potential to be BLA submitted in bispecifics the best-in-class BCMAxCD3 bispecific with its clinical profile, dosing, and December 2023 for R/R multiple myeloma, pending FDA acceptance administration Confirmatory Phase 3 stu
Slide 18: Linvoseltamab has differentiated clinical profile in r/r multiple myeloma
Within the BCMA bispecific class, linvoseltamab has differentiated and compelling clinical profile in r/r multiple myeloma Teclistamab - FDA Approved Elranatamab - FDA approved Linvoseltamab* (per U.S. FDA Prescribing Information*; n=110) (per U.S. FDA Prescribing Information*; n=97) (per LINKER-MM1
Slide 19: Progressing CD28 costimulatory bispecifics
Progressing CD28 costimulatory bispecifics Dose Proof-of- Dose Escalation Mechanism Expansion Status / Next Steps Combined with: PSMAxCD28 Enrolling monotherapy cohort; Cemiplimab PSMAxCD3 Prostate Cancer combo with PSMAxCD3 to start 1H24 EGFRxCD28 Expansion cohorts with cemiplimab Cemiplimab Solid
Slide 20: Regeneron's approach to obesity: combinations to improve quality of weight loss
Regeneron’s approach to obesity: combinations with leading medicines aim to improve quality of weight loss Incretin-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 decreases
Slide 21: Obesity clinical program to start in mid-2024
Obesity clinical program to start in mid-2024 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 weight loss post semaglutide discontinuation • Enroll
Slide 22: Next-generation approach to anticoagulation via Factor XI inhibition
Next-generation approach to anticoagulation via Factor XI inhibition offers potential for blood clot prevention with minimal bleeding REGN9933 and REGN7508: Both Factor XI antibodies rapidly advancing to pivotal trials starting in late 2024/early 2025 Intrinsic Coagulation Current standard of care:
Slide 23: Regeneron Genetic Medicines: multiple investigational approaches
Regeneron Genetic Medicines: multiple investigational approaches for treatment of genetic diseases Established clinical proof-of-principle across several diseases with novel genetic medicine technologies siRNA CRISPR Gene Silencing Knockout and Insertion AAV Genome Editing Gene Therapy (alone and an
Slide 24: Regeneron Genetic Medicines pipeline
Regeneron Genetic Medicines pipeline Select Pre-IND Candidates Phase 1 Phase 2 Phase 3 SOD1* CIDEB* ALN-PNP* ALN-APP* ALN-HSD Pozelimab + Cemdisiran SOD1 siRNA CIDEB siRNA PNPLA3 siRNA APP siRNA HSD17B13 siRNA C5 Antibody + C5 siRNA SOD1 ALS NASH NASH Early-onset Alzheimer’s NASH Myasthenia gravis a
Slide 25: Geographic atrophy: Extending our C5 siRNA + antibody approach to ophthalmology
Geographic atrophy (in dry AMD): Extending our C5 siRNA + antibody approach to ophthalmology Pivotal Phase 3 program to initiate in 2H 2024 Current Geographic Regeneron Opportunity Atrophy Landscape (Pozelimab + Cemdisiran Combo) • ~1M diagnosed in U.S. • Increasing diagnosis and Market • Leadership
Slide 26: Regeneron restores hearing in a profoundly deaf child
Regeneron restores hearing in a profoundly deaf child DB-OTO AAV-based dual-vector gene therapy delivered to the inner ear to rescue hearing in infants Gene therapy for genetic hearing loss Preliminary results for first patient dosed: Profoundly deaf child at baseline, demonstrates markedly Potentia
Slide 27: 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 † REGN5459 (BCMAxCD3) REGN9933 (Factor XI) pozelimab + cemdisiran‡ ° REGN5837 (CD22xCD28) (anti-C5 + C5 siRNA) REGN7257 (IL-2Rγ) odronextamab (CD20xCD3) vidutolimod (TLR9) §
Slide 28: 2024 key upcoming milestones
2024 key upcoming milestones Ophthalmology Solid Organ Oncology • EU decision for aflibercept 8 mg in wAMD and DME ✓ • Report potentially pivotal interim analysis of Libtayo in Adjuvant CSCC (2H) • Japan decision for aflibercept 8 mg in wAMD and DME ✓ • Report potentially pivotal initial results fro
Slide 29: Continuing to deliver on capital allocation priorities
Continuing to deliver on capital allocation priorities to drive long-term growth Internal Business Repurchase Investment Development Shares in our world-class R&D capabilities to expand pipeline and maximize • Deploy excess cash to and capital expenditures to commercial opportunities opportunistical
Slide 30: Three responsibility focus areas reflect our "doing well by doing good" ethos
Three responsibility focus areas all reflect our “doing well by doing good” ethos Improve the lives of people with serious diseases Our mission: • Pipeline innovation • Access to medicine and fair pricing Use the power of • Patient advocacy Foster a culture science to repeatedly of integrity and exc
Slide 31: GAAP to Non-GAAP Reconciliations
GAAP to Non-GAAP Reconciliations 31
Slide 32: Abbreviations and Definitions
Abbreviations and Definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L First line FIH First in human PD-1/PD-(L)1 Programmed cell death protein/(ligand) 1 AAV Adeno-associated virus FL Follicular lymphoma PDUFA Prescription Drug User Fee Act ALS Amyotrophic lateral
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