Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (November 2022)
26 slides from Regeneron Pharmaceuticals's investor presentation, November 2022
Slide 1: Regeneron Corporate Presentation
Regeneron Corporate Presentation N o v e m b e r 2 0 2 2 This non-promotional presentation is intended for the investor audience and contains investigational data as well as forward-looking statements; actual results may vary Regeneronmaterially - Internal Use Only
Slide 2: Note regarding forward-looking statements & non-GAAP financial measures
Note regarding forward-looking statements & 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 events
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 30+ therapeutic #1 prescribed FDA ~$3.6B into candidates in various stages approved anti-VEGF R&D in 2022* of clinical development treatment for retinal disease Advancing a best-in-class, Acquired full ri
Slide 4: Delivering Results Across the Organization
Delivering Results Across the Organization Notable R&D Pipeline Advancements Positive pivotal data for 8mg aflibercept for wAMD an DME presented at AAO Granted pediatric exclusivity, extending regulatory exclusivity through May 17, 2024 sBLA accepted for ROP with priority review (PDUFA Feb 11, 2023)
Slide 5: EYLEA: 10+ Years of Patient Impact
EYLEA®: 10+ Years of Patient Impact Extending leadership position based on efficacy and safety that has transformed millions of lives; 55+ million doses administered worldwide since launch Developed using our proprietary Trap technology, development on aflibercept began in 2004 and became Regeneron’
Slide 6: Aflibercept 8 mg has the Potential to Shift Treatment Paradigm
Aflibercept 8 mg has the Potential to Shift Treatment Paradigm Illustrative Current Treatment Potential Future Paradigm Treatment Paradigm Proportion of Patients Treated Patients eligible for Reducing treatment aflibercept 8 mg could benefit burden without from extended dosing compromising vision in
Slide 7: Retinal Franchise Poised for Sustainable Long-Term Growth and Value Creation
Retinal Franchise Poised for Sustainable Long-Term Growth and Value Creation aflibercept 8 mg EYLEA is the #1 prescribed FDA approved Plan to submit new Biologics License Application anti-VEGF treatment for retinal disease for wAMD and DME indications in late 2022 ~50% of U.S. anti-VEGF category sha
Slide 8: At 48 Weeks Vast Majority of Aflibercept 8 mg Patients Maintained Q12W+ Dosing Intervals
At 48 Weeks Vast Majority of Aflibercept 8 mg Patients Maintained Q12W+ Dosing Intervals All 8mg arms (n=456)^ All 8mg arms (n=628)^ 7% Wet Age-Related 17% Diabetic Macular Macular Degeneration Edema 93% 83% Q12W+ Q8W* Q12W+ Q8W* 8 *Patients shortened based on DRM assessments at some point through W
Slide 9: Dupixent: Strong Performance Across All Approved Indications
Dupixent®: Strong Performance Across All Approved Indications With Significant Opportunity For Sustained Growth ~$2.3B 3Q 2022 global net product sales Net Product Sales, $ Million U.S. $506 ROW +40% Dermatology Respiratory Gastroenterology $510 Atopic Dermatitis Asthma Eosinophilic $1,824 (~2.2M) E
Slide 10: Dupixent & Itepekimab COPD Phase 3s Underway
Dupixent® & Itepekimab (anti IL-33) COPD Phase 3s Underway Two-pronged approach against uncontrolled, moderate-to-severe COPD Dupixent potential to address Type 2 COPD Achieved prespecified efficacy milestone in interim analysis of Non-Type 2 Type 2 first Phase 3 study which triggered second Phase 3
Slide 11: Continued Progress & Developments Across Oncology Pipeline
Continued Progress & Developments Across Oncology Pipeline Regeneron positioned to enhance and extend treatment benefit across many cancer settings Dermato-Oncology Non-Small Cell Lung Cancer • First-in-class leading approved systemic treatment for advanced CSCC; • Approved as monotherapy in 1L appr
Slide 12: 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 13: 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 Odronextamab Linvoseltamab PSMAxCD3 MUC16xCD3 (CD20xCD3) (BCMAxCD3) (REGN4336) (REGN4018) METxMET MET-altered advanced R/R B-NHL, R/R
Slide 14: Key Data Read-Outs Expected Beginning in 2H 2022
Key Data Read-Outs Expected Beginning in 2H 2022 Upcoming Data Disclosure: Tumor Type Initial Indication 2H 2022 2023 2024+ Lymphoma Odronextamab Hematology Multiple myeloma Linvoseltamab Neoadjuvant CSCC Cemiplimab ✓ Adjuvant CSCC Cemiplimab Dermato-oncology Advanced CSCC (2L) Vidutolimod Cemiplima
Slide 15: Bispecifics for Heme-Onc Malignancies: Upcoming New Data at ASH 2022
Bispecifics for Heme-Onc Malignancies: Upcoming New Data at ASH 2022 Combinations with costimulatory bispecifics and other agents entering clinic soon Odronextamab Linvoseltamab (CD20xCD3)* (BCMAxCD3)* Summary – A single, off-the-shelf bispecific, effective in both indolent Efficacy – Preliminary ea
Slide 16: Regeneron Technologies Power Our Pipeline: TRAPs, Antibodies and Bispecifics
Regeneron Technologies Power Our Pipeline: TRAPs, Antibodies and Bispecifics xx TARGET VELOCIGENE®️ TURNKEY DISCOVERY & VALIDATION THERAPEUTICS: TRAPs & ANTIBODIES VELOCIMOUSE®️ (BISPECIFICS & Rubine / Marigold / White (Late 2016) COSTIMS) Protein VELOCIMMUNE®️ Expression Sciences TECH Rubine / Mari
Slide 17: Synergistic Collaborations Supercharge Regeneron's Future
Synergistic Collaborations Supercharge Regeneron’s Future Turnkey Genetics Therapeutics Platforms Unlocking capabilities of mouse and Learnings from mouse genetics human genetics through Existing Turnkey Technologies Novel Turnkey Technologies Biologicals Gene Medicines siRNA Genome Gene TRAPs Antib
Slide 18: 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 • 110+ collaborations globally Novel Genetics
Slide 19: Regeneron Genetics Medicines
Regeneron is investing in and delivering REGENERON GENETICS technologies well beyond antibodies MEDICINES • 5 genetics medicines programs in the clinic Building the Pipeline for the Future • 3-5 additional potential targets to advance to IND-enabling studies in next 12 months Pre-IND Clinical Develo
Slide 20: 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 OR AUTHORIZED fianlimab (LAG-3) cemiplimab (PD1) cemiplimab (PD1) REGN4336 (PSMAxCD3) vidutolimod (TLR9) fianlimab (LAG-3) REGN5093 (METxMET) ubamatamab (MUC16xCD3)
Slide 21: Multiple Potential FDA Submissions: 2022-2024+
Multiple Potential FDA Submissions: 2022-2024+ 2022 2023 2024+ EYLEA DUPIXENT* Fianlimab (LAG3) + LIBTAYO Itepekimab (IL-33)* Q16W in NPDR (1H22) ✓ Chronic Inducible Urticaria - Cold Advanced Melanoma Chronic Obstructive Pulmonary Disease EYLEA DUPIXENT* REGN4461 (LEPR) REGN5713-5714-5715 (Betv1) Re
Slide 22: Key Upcoming Milestones (Next 12 Months)
Key Upcoming Milestones (Next 12 Months) Ophthalmology Solid Organ Oncology • Submit BLA for 8mg aflibercept in DME and wAMD (2H22) • Initiate Phase 3 for fianlimab with Libtayo in 1L adjuvant melanoma • FDA decision for EYLEA in ROP (PDUFA 2/11/2023) • Report data from FIH study of fianlimab with L
Slide 23: Strong Financial Position Enabling Critical Investments
Strong Financial Position Enabling Critical Investments Capital allocation priorities reflect business priorities Internal Investment $1.8B investment in Tarrytown R&D facilities in our world-class R&D capabilities and capital announced in July 2021 expenditures to support sustainable growth Continu
Slide 24: Three Responsibility Focus Areas Reflect Doing Well by Doing Good Ethos
Three Responsibility Focus Areas all Reflect “Doing Well by Doing Good” Ethos 1 2 3 Improve the lives of people Foster a culture of integrity Build sustainable with serious diseases and excellence communities Our Mission: Use the power of science to repeatedly bring new medicines to people with seri
Slide 25: There is much to be proud of, but our job is never done
There is much to be proud of, but our job is never done Select 2022 Honors Newsweek: America’s Most Responsible Companies Civic 50: Most Community-Minded Companies in the Nation Prix Galien Award: Best Biotechnology Product Award (Inmazeb) Science: #3 Top Employer Select 2021 Honors Fast Company: Be
Slide 26: Reconciliation of Non-GAAP Results and Total Revenue Excluding REGEN-COV
Reconciliation of Non-GAAP Results and Total Revenue Excluding REGEN-COV (casirivimab and imdevimab) 26 See slide 2 for additional important information regarding non-GAAP financial measures included in this presentation
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