Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (February 2023)
31 slides from Regeneron Pharmaceuticals's investor presentation, February 2023
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation F e b r u a r y 2 0 2 3 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 the future, looking ahead
Executing on our Investing in Looking ahead core competencies Regeneron to the future Investing ~35 therapeutic #1 prescribed FDA ~$4.3B into candidates in various stages approved anti-VEGF R&D in 2023* of clinical development treatment for retinal disease Advancing a best-in-class, Acquired full ri
Slide 4: 2022 progress across key strategic priorities positions Regeneron for long-term value
2022 progress across key strategic priorities positions Regeneron to deliver long-term shareholder value Positive aflibercept 8 mg data position retinal franchise for prolonged leadership Exceptional Dupixent clinical profile and commercial Potential upcoming execution, regulatorynow approved to tre
Slide 5: Delivering results across the organization
Delivering results across the organization Notable R&D Pipeline Advancements • BLA for aflibercept 8 mg in wAMD and DME submitted to FDA in December • EC approval for EYLEA in ROP and sBLA under priority review for ROP (PDUFA Feb 11, 2023) • EC approval for PN and EoE, the first and only medicine in
Slide 6: Meaningful advances across therapeutic areas in 2022
Meaningful advances across therapeutic areas in 2022 Ophthalmology Immunology Oncology Broader Pipeline EYLEA (VEGF Trap) DUPIXENT (anti-IL-4/IL-13) LIBTAYO (anti-PD-1) • sBLA accepted for priority review for Evkeeza in • Received six months of • FDA and EC approval as • FDA approval in combination
Slide 7: Maintaining U.S. leadership with 2022 revenue growth outpacing anti-VEGF category
Maintaining U.S. leadership with 2022 revenue growth continuing to outpace anti-VEGF category growth Standard-of-care based on 11+ years of safety and efficacy experience, breadth of indications, and flexible dosing regimens $6.3 #1 anti-VEGF treatment for retinal diseases +8% $5.8 • FY 2022 U.S. ne
Slide 8: Aflibercept 8 mg has potential to shift treatment paradigm
Aflibercept 8 mg has potential to shift treatment paradigm; positions Regeneron’s retinal franchise for prolonged leadership Aflibercept 8 mg has the potential to become the next-generation standard-of-care anti-VEGF treatment BLA submission completed in December 2022 Reducing treatment burden for p
Slide 9: 93% of aflibercept 8 mg DME patients maintained dosing intervals ≥12 weeks
93% of aflibercept 8 mg DME patients maintained dosing intervals ≥12 weeks through week 48 Aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferior vision gains compared to aflibercept 2 mg 8-week dosing regimen Aflibercept 8 mg Q12W Aflibercept 8 mg Q16W Pooled Aflibercept 8 mg (N=300
Slide 10: Cross-trial comparison of aflibercept 8 mg and faricimab in DME patients
This slide has been edited from its original version. Cross-trial comparison of aflibercept 8 mg and faricimab in DME patients Dosing intervals of DME patients randomized to aflibercept Dosing intervals of DME patients randomized to faricimab 8 mg Q16W arm (N=156) in PHOTON study, through 48 weeks 6
Slide 11: 83% of aflibercept 8 mg wAMD patients maintained dosing intervals ≥12 weeks
83% of aflibercept 8 mg wAMD patients maintained dosing intervals ≥12 weeks through week 48 Aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferior vision gains compared to aflibercept 2 mg 8-week dosing regimen Aflibercept 8 mg Q12W Aflibercept 8 mg Q16W Pooled Aflibercept 8 mg (N=31
Slide 12: Cross-trial comparison of aflibercept 8 mg and faricimab in wAMD patients
Cross-trial comparison of aflibercept 8 mg and faricimab in wAMD patients Dosing intervals of wAMD patients randomized to Dosing intervals of wAMD patients randomized to faricimab 6 mg in TENAYA and LUCERNE studies (n=665)* aflibercept 8 mg Q16W arm (N=312) in PULSAR study (Dose interval shortening
Slide 13: In 2022, Dupixent global net product sales grew 40% and exceeded $8.6 billion
In 2022, Dupixent global net product sales grew 40% and exceeded $8.6 billion Incremental market penetration, new indications, and younger populations represent significant opportunity for continued growth Regulatory progress across 5 diseases: Atopic Dermatitis Approved by FDA as first biologic med
Slide 14: 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/Adol 12+ Adolescent 12+ Adults 18+ Ped 6-11
Slide 15: 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) • Potential to address Type 2 COPD • Potential to address COPD in Former Smokers in both current and former smokers former smokers Dupixent or • Two Phase 3 st
Slide 16: Unique flexibility of internally developed pipeline drives novel combinations
Unique flexibility of internally developed pipeline drives potential for novel and differentiated combinations CD3 Bispecifics: “Signal 1” Tumor-Targeted Biparatopics Designed to bridge tumor-associated Designed to disrupt cellular signaling antigens on cancer cells with CD3- and/or deliver a cytoto
Slide 17: Unique flexibility of internally developed pipeline drives novel combinations
Unique flexibility of internally developed pipeline drives potential for novel and differentiated combinations CD3 Bispecifics: “Signal 1” Odronextamab Linvoseltamab PSMAxCD3 MUC16xCD3 (CD20xCD3) (BCMAxCD3) (REGN4336) (REGN4018) Tumor-Targeted Biparatopics R/R B-NHL, R/R Multiple Metastatic Recurren
Slide 18: Continued progress & developments across oncology pipeline
Continued progress & developments across oncology pipeline Regeneron positioned to enhance and extend treatment benefit across many cancer settings Solid tumors Hematology-Oncology Non-Small Cell Lung Cancer • Fianlimab (LAG-3) – Phase 3 study in 1L advanced and • Approved as monotherapy in adjuvant
Slide 19: Continuing momentum in oncology pipeline in 2023 and beyond
Continuing momentum in oncology pipeline in 2023 and beyond Upcoming expected data disclosure Tumor type Initial indication 2H22 2023 2024+ Lymphoma Odronextamab Odronextamab Hematology Multiple myeloma Linvoseltamab Linvoseltamab Neoadjuvant CSCC Cemiplimab Cemiplimab Adjuvant CSCC Vidutolimod Cemi
Slide 20: Costimulatory bispecifics platform: Status and next steps
Costimulatory bispecifics platform: Status and next steps Costimulatory bispecifics will be combined with both Libtayo and a growing list of CD3 bispecifics Prostate Ovarian EGFR + Solid Tumors Hematology Cancer Cancer PSMAxCD28 (REGN5678) MUC16xCD28 (REGN5668) EGFRxCD28 (REGN7075) CD22xCD28 (REGN58
Slide 21: Next-gen COVID antibody active against all known Omicron variants
Next-gen COVID antibody binds outside variable RBD and has demonstrated high neutralization activity against all known variants and lineages Next-Gen Differentiated vs. prior antibody approaches Variant Lineage REGEN-COV* Xevudy† Evusheld^ Bebtelovimab¶ mAb • Binding site outside of immunodominant,
Slide 22: Evolution of Regeneron's turn-key technologies
Evolution of Regeneron’s turn-key technologies powering our science and pipeline COMMITMENT TO MOUSE GENETICS MOUSE GENETICS »»» VELOCIMMUNE MOUSE with humanized immune system »»» Multiple approved & clinical–stage antibodies & bispecifics Regeneron is founded UNLOCKING POWER OF HUMAN GENETICS Regen
Slide 23: Regeneron genetics medicines
Regeneron genetics medicines Powerful resource linking human genetic variation to disease; empowering strategic partnerships to drive the future of medicine World leading human sequencing • ~2M human exomes sequenced • Linked to Electronic Health Records • 100+ collaborations globally Novel genetics
Slide 24: Regeneron is investing in technologies well beyond antibodies
Regeneron is investing in and delivering technologies well beyond antibodies Regeneron genetics medicines • 5 genetics medicines programs in the clinic Pre-IND Clinical development • 3-5 additional potential targets to advance to FACTOR 8 GENE DB-OTO3 POZELIMAB + ALN-APP1 IND-enabling studies in nex
Slide 25: Regeneron-discovered, approved and investigational medicines across diverse diseases
Regeneron-discovered, approved and investigational medicines across a wide and diverse set of diseases Phase 1 Phase 2 Phase 3 Approved fianlimab (LAG-3) cemiplimab (PD1) cemiplimab (PD1) REGN4336 (PSMAxCD3) vidutolimod (TLR9) fianlimab (LAG-3) REGN5093 (METxMET) ubamatamab (MUC16xCD3) REGN5093-M114
Slide 26: Multiple potential FDA submissions: 2022-2024+
Multiple potential FDA submissions: 2022-2024+ 2022 2023 2024+ EYLEA DUPIXENT* LIBTAYO Itepekimab* Retinopathy of Prematurity CINDU-Cold (2H) Adjuvant CSCC COPD DUPIXENT* DUPIXENT* DUPIXENT* Fianlimab + LIBTAYO Eosinophilic Esophagitis Pediatric EoE (mid) Type 2 COPD Advanced Melanoma DUPIXENT* PRAL
Slide 27: 2023 key upcoming milestones
2023 key upcoming milestones Ophthalmology Solid Organ Oncology • FDA decision for EYLEA in ROP (Q1) • Initiate Phase 3 study for fianlimab+Libtayo in perioperative • BLA acceptance for aflibercept 8 mg in DME and wAMD (Q1) melanoma (mid-2023) as well as Phase 2/3 studies in 1L advanced NSCLC (1H) a
Slide 28: Allocated ~$3.4 billion to business development and share repurchases in 2022
Allocated ~$3.4 billion to business development and share repurchases in 2022 • $1.8 billion investment in Tarrytown R&D facilities Internal Investment announced in July 2021 in our world-class R&D capabilities and capital expenditures to support sustainable growth • Continued investments in researc
Slide 29: 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 1 2 3 Improve the lives of people Foster a culture of Build sustainable with serious diseases integrity and excellence communities • Pipeline innovation • Product quality and safety • STEM education - sponsorship • Acc
Slide 30: GAAP to non-GAAP reconciliation
GAAP to non-GAAP reconciliation 30 The current period’s foreign currency net product sales values are converted into U.S. dollars using the average exchange rates from the prior period.
Slide 31: Abbreviations & definitions
Abbreviations & definitions Abbreviation Definition Abbreviation Definition Abbreviation Definition 1L Front line CSU Chronic spontaneous urticaria NASH Non-alcoholic steatohepatitis 2L+ Second line and beyond DLBCL Diffuse large B-cell lymphoma NEJM New England Journal of Medicine 3L+ Third line an
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