Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (November 2021)
27 slides from Regeneron Pharmaceuticals's investor presentation, November 2021
Slide 1: Regeneron Corporate Presentation
N o v e m b e r 2 0 2 1 R E G E N E R O N C O R P O R AT E P R E S E N TAT I O N
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: Strong Core Brands, New Launches and Diverse Pipeline
Strong and Growing Period of A Broad and Core Brands New Launches Diverse Pipeline 1L Non-Small Cell Lung Cancer and Dupixent in pivotal trials for Basal Cell Carcinoma 8 additional Type 2 diseases Pediatric Asthma Advancing immuno-oncology pipeline and combinations COVID-19 30+ therapeutic candidat
Slide 4: Strong Execution in 3Q 2021
Strong Execution in 3Q 2021 R&D Pipeline Advancements Ph2 results for High Dose Aflibercept in wAMD Positive Ph3 results in four potential new indications (CSU, PN, EoE, Pediatric AD) Received approval in asthma 3Q21 Total Revenues +51% growth for children ages 6 - 11 YoY* +18% growth excl. COVID-19
Slide 5: EYLEA, Dupixent, and Oncology are Core to Diversified Growth Strategy
EYLEA, Dupixent, and Oncology are Core to Diversified Growth Strategy Specialized programs offer additional growth potential Specialized growth EYLEA Dupixent* Oncology opportunities: Infectious Disease • Execute and grow in • Transform treatment • Realize potential COVID-19^ & Ebola wet AMD and of
Slide 6: EYLEA: Extending Leadership Position
EYLEA®: Extending Leadership Position Setting a high bar on efficacy/safety/convenience for current and future potential competition Extending Category Leadership ▪ 3Q21 U.S. net product sales of $1.47Bn (+12% YoY) $4.9 $4.6 ▪ Sales gains and favorable demographic trends $4.1 $3.7 $3.3 Maximize Grow
Slide 7: Dupixent: Strong Growth Trajectory
Dupixent®: Strong Growth Trajectory Broad-based growth across all +55% worldwide sales growth in 3Q21 vs. 3Q20 approved indications Significant market opportunities U.S. ROW $406 support future growth $352 $1,257 $246 $301 $1,147 Advancing clinical development $221 $926 $962 program across EIGHT Typ
Slide 8: Dupixent: Driving Leverage in Collaboration Profitability
Dupixent®: Driving Leverage in Collaboration Profitability Antibody Collaboration Share of Profits / (Losses)* (in Millions) $500 $400 $300 $200 $100 $0 ($100) 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 4Q20 1Q21 2Q21 3Q21 8 * Share of profits/(losses) are derived from global net product
Slide 9: Substantial Patient Opportunity in Type 2 Inflammatory Diseases for Dupixent
Substantial Patient Opportunity in Type 2 Inflammatory Diseases for Dupixent® Up to 4M+ Atopic Eligible Dermatitis Asthma CRSwNP 2022e 2023e 2024+e Patients Eosinophilic Esophagitis Bullous Type 2 Pemphigoid COPD 48k 2.3M* 975k* 90k 300k 27k Chronic Spontaneous Urticaria CRSsNP Since launch, ~270k p
Slide 10: Dupixent & Itepekimab COPD Phase 3s Underway
Dupixent & Itepekimab (anti IL-33) COPD Phase 3s Underway Two-pronged approach against COPD Dupixent potential to address Type 2 COPD Achieved prespecified efficacy milestone in interim analysis of first Ph3 study Non-Type 2 Type 2 Eosinophils ≥300/μl Both former and current smokers Dupixent or 2 Ph
Slide 11: Libtayo - Foundational Therapy to Our Oncology Strategy
Libtayo - Foundational Therapy to Our Oncology Strategy COMPETE, ENHANCE, and EXTEND treatment benefits in monotherapy and combination settings Dermato-oncology • First approved anti-PD-1 in advanced CSCC; adjuvant studies enrolling U.S. ROW • FDA and EMA Approved as first-in-class anti-PD-1 in adva
Slide 12: Oncology Strategy: Aspire to Compete, Enhance, & Extend
Oncology Strategy: Aspire to Compete, Enhance, & Extend COMPETE LIBTAYO delivers potentially ‘best-in- class’ data in tumors responsive to Oncology Opportunity PD-1 monotherapy ENHANCE Patient Benefit ENHANCE Even for PD-1 responsive tumors, more than half of patients do not respond EXTEND EXTEND CO
Slide 13: Significant Opportunity to Enhance & Extend Treatment Benefits
Significant Opportunity to Enhance & Extend Treatment Benefits Number of Cancer Cases Per Year Despite the advancements in the field, * Breast Lung there are many cancers that don’t * Colorectal respond to anti PD-1 monotherapy * Prostate Stomach Liver Cervix Esophagus Even for those cancers that ar
Slide 14: Regeneron's Oncology Toolkit Provides Unique Combinatorial Flexibility
Regeneron’s Oncology Toolkit Provides Unique Combinatorial Flexibility VelocImmune® Bispecifics Collaborations Antibodies Adicet BioNTech PD-1 (LIBTAYO) CD3 Costimulatory New Classes of Vyriad Bispecifics Bispecifics Bispecifics Replimmune LAG-3 CD20 PSMA METxMET Others GITR BCMA EGFR METxMET ADC CT
Slide 15: Bispecifics For Hematologic Cancers
Bispecifics For Hematologic Cancers Odronextamab Potential best-in-class efficacy* R/R Follicular Lymphoma Anti Anti • ORR=90%, CR=70% CD3 CD20 R/R DLBCL (CAR-T naïve) R/R DLBCL (post-CAR-T) • ORR=55%, CR=55% • ORR=33%, CR=21% Patient enrollment has resumed for FL and DLBCL in potentially pivotal mo
Slide 16: Bispecifics for Solid Tumors: Enhance And Extend Benefits Of Checkpoint Inhibitors
Bispecifics for Solid Tumors: Enhance And Extend Benefits Of Checkpoint Inhibitors Lung, Advanced Cancers Ovarian Cancer Prostate Cancer REGN7075 (EGFRxCD28) REGN5668 (MUC16xCD28) REGN5678 (PSMAxCD28) Evaluating combination Evaluating combination with LIBTAYO Evaluating combination with with LIBTAYO
Slide 17: Broad Oncology Pipeline & Combinations Continue to Advance
Broad Oncology Pipeline & Combinations Continue to Advance ONGOING LIBTAYO* Advanced Lung cancer (chemo combo); Adjuvant CSCC REGN3767 (LAG-3) + LIBTAYO* Advanced melanoma REGN6569 (GITR) + LIBTAYO* Solid tumors REGN4018 (MUC16xCD3) + LIBTAYO* 2+ line Ovarian cancer REGN5668 (MUC16xCD28) + REGN4018
Slide 18: REGEN-COV COVID-19 Combination Therapy
The first COVID-19 combination therapy to receive EUA 5 months Clinical Trials Supply Program Initiation 10 months EUA Granted ✓ Signed new supply agreement in Sept. 2021 to supply 1.4 million additional doses to the U.S. Government Clinical Data ✓ Partnered with Roche to manufacture and distribute
Slide 19: Evkeeza: Rare Disease Opportunity
Evkeeza: Rare Disease Opportunity Address Unmet Need in Patients with HoFH Build Rare Disease Strategy Now Approved Apply Cardiometabolic Expertise Found that patients with loss-of-function mutations in their ANGPTL3 gene have significantly lower levels of key blood lipids, including LDL-C Evinacuma
Slide 20: Supercharging the Future of Genetics and Turnkey Therapeutics Platforms
Supercharging the Future of Genetics and Turnkey Therapeutics Platforms at Regeneron Unlocking capabilities of mouse and Learnings from mouse genetics human genetics through Existing Turnkey Technologies Novel Turnkey Technologies Biologicals Gene Medicines Genome Gene TRAPs Antibodies & Bispecifics
Slide 21: Regeneron Genetics Medicines
Regeneron is investing in and delivering REGENERON GENETICS technologies well beyond antibodies MEDICINES • 3 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 22: Genome Editing – Knockout: TTR Collaboration With Intellia
Genome Editing – Knockout: TTR Collaboration With Intellia First Human Proof-of-Concept Achieved for First Systemic CRISPR-based Therapeutic • First-in-human data validate our CRISPR-based TTR knockout approach Landmark Clinical Data at Peripheral Nerve Society o Single dose with NTLA-2001 led to do
Slide 23: Capital Allocation Priorities Leverage Financial Strength
Capital Allocation Priorities Leverage Financial Strength to Drive Long-Term Growth and Shareholder Value 1. Invest in our best-in-class R&D capabilities 2. Pursue and fund business development opportunities to enable and synergize our R&D capabilities and technologies 3. Return cash to shareholders
Slide 24: 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 NTLA-2001# (TTR KO REGEN-COV^ (SARS-CoV-2) CRISPR/Cas9) REGEN-COV^ (SARS-CoV-2) Dupilumab* (IL-4R) REGEN-COV^ (SARS-CoV-2) Fianlimab (LAG-3) REGN9933 (Factor XI) Cemiplimab*
Slide 25: Multiple Potential Regulatory Submissions: 2021-2023+
Multiple Potential Regulatory Submissions: 2021-2023+ 2021 2022 2023+ REGEN-COV†† Odronextemab (CD20xCD3) DUPIXENT* Itepekimab (IL-33)* COVID-19‡ Treatment & Prophylaxis B Cell NHL Eosinophilic Esophagitis Chronic Obstructive Pulmonary Disease DUPIXENT* REGN5458 (BCMAxCD3) DUPIXENT* REGN1908-1909 (F
Slide 26: Key Upcoming Milestones
Key Upcoming Milestones EYLEA: Ph3 data readout for High Dose aflibercept formulation Dupixent • Submit sBLA and MAA for pediatric AD (6 months – 5 years) • Complete regulatory submission for EoE • Additional Phase 3 readouts for CSU and PN REGEN-COV • FDA decision regarding expansion of EUA to incl
Slide 27: Reconciliation of GAAP Net Income to Non-GAAP Net Income and of Net Cash Position
Reconciliation of GAAP Net Income to Non-GAAP Net Income and of Net Cash Position REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF NET CASH POSITION (Unaudited) (In millions) 27 *See slide 2 for additional important information regarding non-GAAP financial measures included in this presentation
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