Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (February 2021)
28 slides from Regeneron Pharmaceuticals's investor presentation, February 2021
Slide 1: Corporate Presentation February 2021
C O R PO RAT E PR ESEN TAT ION FEBRUARY 2021
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: A Diversified Growth Story
A DIVERSIFIED GROWTH STORY Strong and Growing Core Entering a Period of New A Broad and Diverse Pipeline Brands Launches 1L Non-Small Cell Lung Cancer and Dupixent in pivotal trials for Basal Cell Carcinoma eight Type 2 diseases Pediatric Asthma Advancing immuno-oncology pipeline and combinations RE
Slide 4: Strong Execution in 4Q 2020 and FY 2020
STRONG EXECUTION IN 4Q 2020 AND FY 2020 R&D Pipeline Advancements EoE, Pediatric Asthma/AD Filed in 1L NSCLC and BCC (PDUFA’s 1Q21) 4Q Total Revenues, YoY* FY20 Total Revenues, YoY^ Leading CD3 & CD28 Bispecifics platform +30% growth +30% growth COVID-19 antibody REGEN-COV cocktail EUA 4Q Non-GAAP E
Slide 5: EYLEA, Dupixent, and Libtayo Are Core to Diversified Growth Strategy
EYLEA, DUPIXENT, AND LIBTAYO ARE CORE TO DIVERSIFIED GROWTH STRATEGY; SPECIALIZED PROGRAMS OFFER ADDITIONAL GROWTH POTENTIAL Specialized growth EYLEA Dupixent* Oncology opportunities: Infectious Disease • Execute and grow in wet • Transform treatment of • Realize potential COVID-19^ & Ebola AMD and
Slide 6: EYLEA: Extending Leadership Position
EYLEA®: EXTENDING LEADERSHIP POSITION Setting a high bar on efficacy/safety/convenience for current and future potential competition Strategic Execution Despite COVID-19 ▪ 4Q20 $1.34Bn (+10% YoY), FY2020 $4.95Bn (+7% YoY)* $4.9 ▪ Sales gains and favorable demographic trends $4.6 $4.1 $3.7 $3.3 Maxim
Slide 7: Dupixent: Strong Growth Trajectory
DUPIXENT®: STRONG GROWTH TRAJECTORY Broad-based growth across all approved indications +56% worldwide sales growth in 4Q20 vs. 4Q19 Significant market opportunities U.S. ROW support future growth $246 $221 $175 $926 Advancing clinical development $176 $770 $851 program across EIGHT Type 2 $146 $605
Slide 8: Dupixent: Driving Leverage in Collaboration Profitability
DUPIXENT®: DRIVING LEVERAGE IN COLLABORATION PROFITABILITY Antibody Collaboration Share of Profits / (Losses)* (in Millions) $250 $200 $150 $100 $50 $0 ($50) ($100) 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 4Q20 * Share of profits/(losses) are derived from global net product sales of Pr
Slide 9: Dupixent & Itepekimab COPD Phase 3s Underway
DUPIXENT & ITEPEKIMAB (ANTI IL-33) COPD PHASE 3s UNDERWAY Two-pronged approach against COPD Dupixent addresses 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 2 Ph3 trials ongoing Dupixe
Slide 10: Substantial Patient Opportunity in Type 2 Inflammatory Diseases for Dupixent
SUBSTANTIAL PATIENT OPPORTUNITY IN TYPE 2 INFLAMMATORY DISEASES FOR DUPIXENT® Up to 4M+ Eligible Atopic Patients in Dermatitis Asthma CRSwNP 2021e 2022e 2023+e U.S. by 2023 Eosinophilic Type 2 Esophagitis COPD 2.3M* 975k* 90k Prurigo 48k 300k Nodularis Chronic CSsNP 74k Spontaneous Urticaria 130k Si
Slide 11: Roadmap to Leadership in Oncology
ROADMAP TO LEADERSHIP IN ONCOLOGY COMPETE, ENHANCE, and EXTEND treatment benefits in monotherapy and combination settings COMPETE LEAD in dermato-oncology U.S. ROW First approved anti-PD-1 in advanced CSCC $25 $23 $17 Accepted for priority review as first-in-class $14 $13 PD-1 in 2L+ BCC (PDUFA 3/3/
Slide 12: Oncology Strategy: Aspire to Compete, Enhance, & Extend
ONCOLOGY STRATEGY: ASPIRE TO COMPETE, ENHANCE, & EXTEND Oncology Opportunity COMPETE: LIBTAYO delivers potentially ‘best-in-class’ data in tumors responsive to PD-1 monotherapy (e.g., skin cancers & NSCLC*) • Compete in large PD-(L)1 opportunity: o >$25Bn, +25% YoY growth^ Patient Benefit ENHANCE EN
Slide 13: Significant Opportunity to Enhance & Extend Treatment Benefits
SIGNIFICANT OPPORTUNITY TO ENHANCE & EXTEND TREATMENT BENEFITS Number of Cancer Cases Per Year * Breast Lung * Colorectal * Prostate Despite the advancements in the field, there are many Stomach cancers that don’t respond to anti PD-1 monotherapy Liver Cervix Esophagus * Thyroid Bladder * Non-Hodgki
Slide 14: Regeneron Oncology Toolkit Leverages Multiple Platforms
REGENERON ONCOLOGY TOOLKIT LEVERAGES MULTIPLE PLATFORMS TO CREATE COMBINATORIAL FLEXIBILITY Bispecifics VelocImmune® CD3 Bispecifics Costimulatory New Classes of Collaborations Antibodies (to link Killer T Cell to Bispecifics Bispecifics (CAR-Ts; Vaccines) (e.g., checkpoint tumor: Signal 1) (to prov
Slide 15: Veloci-Bi Approach Can Create, Manufacture, and Develop Bispecifics
REGENERON’S VELOCI-BI® APPROACH CAN CREATE, MANUFACTURE, AND DEVELOP HIGH-QUALITY BISPECIFICS OF ANY DESIRED SPECIFICITY Tumor VELOCI-BI® Cell Killer T Killer T TAA1,TAA2 Cell Cell VelociGene® and VelocImmune® technologies are fundamental Anti- CD20 Anti- • Foundation for Dupixent, Praluent, Libtayo
Slide 16: Odronextamab (CD20xCD3): Deep and Durable Responses
ODRONEXTAMAB (CD20xCD3): DEEP AND DURABLE RESPONSES American Society of Hematology (ASH) Dec 2020 update: • A single bispecific, effective in both indolent R/R Follicular Lymphoma R/R DLBCL (CAR-T naïve) R/R DLBCL (post-CAR-T) and aggressive lymphomas, including patients who failed CAR-Ts • ORR=90%,
Slide 17: REGN5458 (BCMAxCD3): Competitive Anti-Tumor Activity
REGN5458 (BCMAxCD3): COMPETITIVE ANTI-TUMOR ACTIVITY; POTENTIALLY REGISTRATIONAL PH2 UNDERWAY IN MULTIPLE MYELOMA REGN5458 Our first BCMAxCD3 bispecific to enter clinic; now in potentially registrational Ph2 dose expansion Phase 1 ASH Dec 2020 update: • Competitive efficacy profile in a heavily R/R
Slide 18: Costim Combinations: Enhance and Extend Benefits of Checkpoint Inhibitors
COSTIM COMBINATIONS: ENHANCE AND EXTEND BENEFITS OF CHECKPOINT INHIBITORS CD28 COSTIMS IN THE CLINIC (SOLID TUMORS) REGN5678 (PSMAxCD28) REGN5668 (MUC16xCD28) REGN7075 (EGFRxCD28) Evaluating combination with Evaluating combination with either Evaluating combination with LIBTAYO MUC16xCD3 or LIBTAYO
Slide 19: Broad Combinations Pipeline Continues to Advance and Grow
BROAD COMBINATIONS PIPELINE CONTINUES TO ADVANCE AND GROW COMBINATIONS INDICATIONS STATUS Resubmit modified study design to ONGOING Odronextamab^ (CD20xCD3) + LIBTAYO* Lymphoma FDA^ REGN4018* (MUC16xCD3) + LIBTAYO* Ovarian cancer Dose escalation ongoing REGN5678 (PSMAxCD28) + LIBTAYO* Prostate cance
Slide 20: REGEN-COV: First Combination Therapy to Receive EUA
REGEN-COV: FIRST COMBINATION THERAPY TO RECEIVE EUA; MANUFACTURING SCALE-UP ONGOING In 4Q20, the U.S. FDA granted Emergency Net Product Sales Use Authorization to the REGEN-COV • 4Q20 Net Product Sales* of $146M ($186M in FY2020) COVID-19 antibody cocktail (casirivimab and imdevimab) Patients • For
Slide 21: REGEN-COV: Broad Clinical Development Program
REGEN-COV: BROAD CLINICAL DEVELOPMENT PROGRAM Program Status Update • EUA granted for mild to moderate COVID-19 in high-risk patients STUDY 2067 Non-Hospitalized (IV) • 57% reduction in medical visits in overall population Seamless Ph1/2/3 • Additional data (including lower 1.2g dose) in 2Q21 • Pass
Slide 22: Evkeeza – Rare Disease Opportunity
EVKEEZA – RARE DISEASE OPPORTUNITY Address Unmet Need in Patients with HoFH Build Rare Disease Strategy PDUFA date 2/11/2021 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
Slide 23: Regeneron-Discovered, Approved and Investigational Medicines
REGENERON-DISCOVERED, APPROVED AND INVESTIGATIONAL MEDICINES ACROSS A WIDE AND DIVERSE SET OF DISEASES REGEN-COV PHASE 1 PHASE 2 PHASE 3 REGEN-COV^ (SARS-CoV-2) REGN5713-5714-5715 REGEN-COV^ (SARS-CoV-2) REGN4461 (LEPR) REGEN-COV^ (SARS-CoV-2) Odronextamab (CD20xCD3) (Betv1) Cemiplimab* (PD-1) Cemip
Slide 24: Empowering Our Collaborations to Advance Genetics-Based Medicines
EMPOWERING OUR COLLABORATIONS TO ADVANCE THE NEXT GENERATION OF GENETICS-BASED MEDICINES World leading human sequencing • >1M human exomes sequenced • linked to EHRs • BIG DATA VIRAL-BASED RNAi CRISPR/Cas9 CAR-T & OTHER CELL GENE THERAPY THERAPEUTICS BASED THERAPIES • RGC helps discover gene • RGC h
Slide 25: Leveraging Financial Strength to Drive Growth and Shareholder Return
LEVERAGING FINANCIAL STRENGTH TO DRIVE GROWTH AND SHAREHOLDER RETURN 2020 Achievements Plans for 2021 Capital Allocation Priorities: 2020 Free Cash Flow: $2.0Bn 1. Invest in our best-in-class R&D capabilities 2. Pursue business development Y/E 2020 Net Cash Position*: $4.7Bn opportunities to enable
Slide 26: 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 B Cell NHL Eosinophilic Esophagitis Chronic Obstructive Pulmonary Disease Fasinumab† REGN5458 (BCMAxCD3)* DUPIXENT* REGN1908-1909 (Feld1) Osteoarthritis
Slide 27: Key Upcoming Milestones (12-18 Months)
KEY UPCOMING MILESTONES (12-18 MONTHS) EYLEA: Ph2 data readout for High Dose formulation Dupixent • Regulatory action in pediatric asthma (6-11 years) • Ph3 data readouts for EoE and Prurigo Nodularis Libtayo • Regulatory action in 1L NSCLC (PDUFA 2/28/21) and 2L+ BCC (PDUFA 3/3/21) • Data anticipat
Slide 28: Reconciliation of GAAP Net Income to Non-GAAP Net Income and 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) *See slide 2 for additional important information regarding non-GAAP financial measures included in this presentation 28
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