Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Q3 2023 Earnings Presentation
31 slides from Regeneron Pharmaceuticals's earnings presentation, Nov 2, 2023
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation N o v e m b e r 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 core competencies, investing in the future, looking ahead
Executing on our Investing in Looking ahead core competencies Regeneron to the future Over 35 therapeutic #1 prescribed FDA candidates in various stages approved anti-VEGF Investing of clinical development treatment for retinal disease ~$4.4B into Advancing a R&D in 2023* best-in-class, Acquired Dec
Slide 4: Delivering results across the organization
Delivering results across the organization Notable R&D Pipeline Advancements • EYLEA HD approved by FDA for wAMD, DME and DR on Aug 18, 2023 • Presented two-year data from pivotal PULSAR study of EYLEA HD in wAMD at EURETINA 2023 • sBLA for pediatric EoE accepted by FDA for Priority Review (PDUFA Ja
Slide 5: Meaningful advances across therapeutic areas in 2023
Meaningful advances across therapeutic areas in 2023 Ophthalmology Immunology Oncology Broader Pipeline EYLEA HD (VEGF Trap) DUPIXENT (anti-IL-4Rα) LIBTAYO (anti-PD-1) • KEVZARA approved by FDA as first and only biologic • FDA approval in wet • EC approval as first and • EC approval in combination w
Slide 6: Maintaining U.S. VEGF category leadership in 2023
Maintaining U.S. VEGF category leadership in 2023 Standard-of-care based on 12 years of safety and efficacy experience, breadth of indications, and flexible dosing regimens EYLEA EYLEA HD #1 anti-VEGF treatment for retinal diseases $0.04 • Q3 2023 U.S. net product sales of EYLEA and EYLEA HD were $1
Slide 7: EYLEA HD now FDA approved in wAMD, DME and DR
EYLEA® HD now FDA approved in wAMD, DME and DR 3Q 2023 Net Product Sales: has the potential to become ~$43 million the next-generation standard- achieved in first partial of-care anti-VEGF treatment quarter following launch FDA approval for wAMD, DME and DR received on Friday, August 18th with comme
Slide 8: 89% of aflibercept 8 mg DME patients maintained dosing intervals ≥12 weeks
2-YR DATA 89% of aflibercept 8 mg DME patients maintained dosing intervals ≥12 weeks through week 96 Aflibercept 8 mg Q12W and Q16W groups had non-inferior vision gains compared to aflibercept 2 mg Q8W, with up to 6 fewer injections Aflibercept 8 mg Q12W Aflibercept 8 mg Q16W Pooled Aflibercept 8 mg
Slide 9: Aflibercept 8 mg and faricimab trial data in DME patients
Aflibercept 8 mg and faricimab trial data 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 mg PTI arm (N=308) in RHINE study, through 52 weeks* Only ~2 in 10 c
Slide 10: 78% of aflibercept 8 mg wAMD patients maintained dosing intervals ≥12 weeks
NEW DATA 78% of aflibercept 8 mg wAMD patients maintained dosing intervals ≥12 weeks through week 96 71% met the extension criteria for ≥16-week dosing intervals, including 47% for ≥20-week intervals and 28% for 24-week intervals Dosing Intervals Through Week 96 Last Assigned Dosing Interval at Week
Slide 11: Aflibercept 8 mg and faricimab trial data in wAMD patients
Aflibercept 8 mg and faricimab trial data 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 was not permitt
Slide 12: Q3 2023 Dupixent global net product sales grew 33% YoY
Q3 2023 Dupixent global net product sales grew 33%* YoY, now annualizing at ~$12B Continued market penetration, new indications, and younger populations represent significant opportunity for growth Regulatory and clinical progress continuing in 2023: Atopic Dermatitis +33% Approved by EC as first bi
Slide 13: 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 Adults 18+ Adults/Adol 12+ Adolescent 12+ Adults 18+ Ped 6-11 Atopic
Slide 14: Dupixent & itepekimab: Two opportunities to address high unmet need in COPD
Dupixent & itepekimab: Two opportunities to address high unmet need in COPD Itepekimab (anti IL-33) Type 2 Non-Type 2 • Potential to address COPD with an • Potential to address COPD in (30% of COPD patients) (70% of COPD patients) Former Smokers eosinophilic phenotype (Eos ≥300/μl) former smokers in
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 +59% • Q3 2023 U.S. net product sales of $144M (+52% YoY) and rest of Growth world sales of $88M (+73%* YoY) vs. 3Q
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 Ubamatamab (CD20xCD3) (BCMAxCD3) (REGN4336) (MUC16xCD3) Tumor-Targeted Biparatopics R/R B-NHL, R/R Multiple Metastatic Recurr
Slide 18: Continued progress & developments across oncology pipeline
Continued progress & developments across oncology pipeline Regeneron positioned to enhance and extend treatment options and benefit across many cancer settings Solid Tumors Hematology-Oncology • Fianlimab (LAG-3) – Presented additional Phase 1 • REGN5668 (MUC16xCD28) – Dose • Odronextamab (CD20xCD3)
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 2023 2024 2025+ Lymphoma Odronextamab Odronextamab CD22xCD28 Hematology Multiple myeloma Linvoseltamab Adjuvant CSCC Cemiplimab Advanced CSCC (PD-1 resistant) Vidutolimod Cemip
Slide 20: Costimulatory bispecifics platform: Status and next steps
Costimulatory bispecifics platform: Status and next steps Costimulatory bispecifics will be studied in combination with both Libtayo and a growing list of CD3 bispecifics Prostate Ovarian EGFR + Solid Tumors Hematology Cancer Cancer PSMAxCD28 (REGN5678) MUC16xCD28 (REGN5668) EGFRxCD28 (REGN7075) CD2
Slide 21: REGN17092 binds outside variable RBD and demonstrates high potency
REGN17092 binds outside variable RBD and demonstrates high potency against >95% of circulating SARS-CoV-2 viruses Expanded agreement with BARDA supporting development of next-generation antibody for COVID-19 prevention Differentiated vs. prior antibody approaches • Binding site outside of immunodomi
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 genetic medicines
Regeneron genetic medicines Powerful resource linking human genetic variation to disease; empowering strategic partnerships to drive the future of medicine World leading human sequencing • Over 2M human exomes sequenced • Linked to Electronic Health Records • 250+ collaborations globally Novel genet
Slide 24: Regeneron is investing in technologies well beyond antibodies
Regeneron is investing in and delivering technologies well beyond antibodies Regeneron genetics medicines • 6 genetics medicines programs in the clinic Pre-IND Clinical development • 3-5 additional potential targets to advance FACTOR 8 GENE FACTOR 9 GENE POZELIMAB + ALN-APP1 to IND-enabling studies
Slide 25: Regeneron-discovered, approved and investigational medicines
Regeneron-discovered, approved and investigational medicines across a wide and diverse set of diseases Phase 1 Phase 2 Phase 3 Approved † REGN4336 (PSMAxCD3) vidutolimod (TLR9) cemiplimab (PD-1) REGN5093 (METxMET) ubamatamab (MUC16xCD3) fianlimab (LAG-3) REGN5093-M114 (METxMET ADC) REGN5668 (MUC16xC
Slide 26: Multiple potential FDA filings: 2023-2025+
Multiple potential FDA filings: 2023-2025+ 2023 2024 2025+ DUPIXENT* DUPIXENT* LIBTAYO Fianlimab + LIBTAYO Pediatric EoE (mid) Type 2 COPD Adjuvant CSCC Advanced Melanoma PRALUENT DUPIXENT* Pozelimab ± cemdisiran+ Pediatric HeFH (mid) CPUO C5-mediated diseases Odronextamab DUPIXENT* Garetosmab B-Cel
Slide 27: 2023 key milestones
Solid Organ Oncology 2023 key milestones • Fianlimab + Libtayo: • Initiate Phase 2 study in perioperative melanoma (4Q) Ophthalmology • Initiate Phase 2/3 studies in 1L advanced NSCLC (1H) • FDA approval for EYLEA in ROP (Q1) • Initiate Phase 2 study in perioperative NSCLC (2H) – now anticipated in
Slide 28: Continuing to deliver on capital allocation priorities
Continuing to deliver on capital allocation priorities to drive long-term growth • $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 rese
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 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 DR Diabetic retinopathy NSCLC Non-small cell lung cancer 2L+ Second line and beyond EC European Commission NTD N-terminal domain 3L+ Third line and beyond EGFR Epidermal growth factor re
Regeneron Pharmaceuticals — Q3 2023 Earnings Presentation on 6ix