Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — Investor Presentation (August 2020)
22 slides from Regeneron Pharmaceuticals's investor presentation, August 2020
Slide 1: Corporate Presentation August 2020
® C O R PO RAT E PR ESEN TAT ION AUGUST 2020 ®
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: Strong Start to 2020 in Challenging COVID-19 Environment
STRONG START TO 2020 IN CHALLENGING COVID-19 ENVIRONMENT KEY CLINICAL/REGULATORY ADVANCES CORPORATE / FINANCIAL EXECUTION • Dupixent: Pediatric AD (ages 6-11) FDA approval; 300mg pre-filled • YTD Revenue: +28% in 1H20 vs. 1H19 pen FDA approval; Part A of Ph3 in EoE met both co-primary and all • YTD
Slide 4: Core Business Continues to Grow
CORE BUSINESS CONTINUES TO GROW Specialized growth EYLEA Dupixent* Oncology opportunities: • Execute in wet AMD and • Transform treatment of • Realize potential diabetic eye diseases Type 2 inflammatory for best-in-class Fasinumab^ (NGF) diseases Osteoarthritis pain • Maximize DR and pre- immunother
Slide 5: EYLEA: Solidifying Market Leadership Position
EYLEA®: SOLIDIFYING MARKET LEADERSHIP POSITION Net Product YoY EYLEA $1.22 Sales Change $1.16 $1.19 $1.17 $1.11 $1.08 $1.07 U.S. $1.11Bn -4% $1.02 $0.98 $0.99 2Q20 Global* $1.75Bn -6% ▪ Demand approaching pre-COVID levels o Pronounced and sustained demand recovery beginning in May ▪ High-dose EYLEA
Slide 6: Dupixent: Strong Execution Across Multiple Indications
DUPIXENT®: STRONG EXECUTION ACROSS MULTIPLE INDICATIONS • Total Dupixent Rx remain resilient $175 U.S. ROW $176 • New initiations impacted by COVID-19: $146 $770 initiations at ~87% of pre-COVID levels $679 $125 $103 $605 • Approved in late May in pediatric AD (6y+): $455 $508 encouraging early laun
Slide 7: Dupixent: Delivering on the Pipeline in a Product Promise
DUPIXENT®: DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE Moderate-to-Severe Atopic Dermatitis Approved in Adults, Adolescents, Peds (6+ years) U.S. APPROVED Moderate-to-Severe Asthma Approved in Adults and Adolescents (12+ years) INDICATIONS* Chronic Rhinosinusitis with Nasal Polyposis Approved
Slide 8: Dupixent: Positive Phase 3 Eosinophilic Esophagitis Data
DUPIXENT®: POSITIVE PHASE 3 EOSINOPHILIC ESOPHAGITIS (EoE) DATA Phase 3 Part A* Results (primary endpoint, week 24, n=81): patients on 300mg QW Dupixent, changes from baseline 69% reduction in disease symptoms compared to 32% for 60% reduction in patients’ esophageal eosinophilic count to placebo (p
Slide 9: Substantial Patient Opportunity in Type 2 Inflammatory Diseases for Dupixent
SUBSTANTIAL PATIENT OPPORTUNITY IN TYPE 2 INFLAMMATORY DISEASES FOR DUPIXENT® Up to 4MM+ Atopic Asthma 2023+ Eligible CRSwNP 2021e 2022e Dermatitis Patients by 2023 Eosinophilic Esophagitis Initiating second 48k Type 2 Phase 3 study Prurigo Nodularis COPD following positive 975k* 90k 74k 300k interi
Slide 10: Libtayo: Leading Treatment for Advanced CSCC in U.S.
LIBTAYO®: LEADING TREATMENT FOR ADVANCED CSCC IN U.S. Advanced CSCC – Total U.S. Patient Share by Products† 9% 11% 22% 14% 31% 13% 40% U.S. ROW 43% 48% 52% 15% 12% 21% 10% $17 $14 $13 18% 8% 15% 6% 12% 6% 14% 5% 9% 12% $4 9% 12% 11% 8% 7% 61% 7% 8% $61 $62 $63 41% 37% 35% $48 29% 29% 26% $41 24% $27
Slide 11: Oncology Strategy: Aspire to Compete, Enhance, Extend
ONCOLOGY STRATEGY: ASPIRE TO COMPETE, ENHANCE, EXTEND Oncology Opportunity COMPETE: LIBTAYO in tumors “responsive” to PD-1 monotherapy (e.g., skin & NCSLC) • PD-(L)1 market: >$21Bn, +42% YoY growth* Patient Benefit ENHANCE ENHANCE: Even for “responsive” tumors, more EXTEND than half of patients do n
Slide 12: 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 13: Establish Libtayo as a Foundation in Oncology
ESTABLISH LIBTAYO® AS A FOUNDATION IN ONCOLOGY COMPETE, ENHANCE, and EXTEND treatment benefits in monotherapy and in combination settings LEAD in dermato-oncology COMPETE ENHANCE & EXTEND CSCC: FIRST-IN-CLASS BCC: FIRST-IN-CLASS DATA NSCLC Investigational • First PD-(L)1 approval for Combinations •
Slide 14: Powerful and Diverse Oncology Portfolio for Rational Combinations
POWERFUL AND DIVERSE ONCOLOGY PORTFOLIO FOR RATIONAL COMBINATIONS BiSpecifics Costims New Classes VelocImmune® Antibodies CD3 BiSpecifics BiSpecifics Collaborations EARLY REGN3767 (LAG-3) REGN5458* (BCMAxCD3) REGN5678 (PSMAxCD28) ISA101b + LIBTAYO (ISA) DEVELOPMENT Solid/hematologic cancers Multiple
Slide 15: 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 REGN1979 (CD20xCD3) + LIBTAYO* Lymphoma FDA in 2H20^ REGN4018* (MUC16xCD3) + LIBTAYO* Ovarian cancer Dose escalation ongoing REGN5678 (PSMAxCD28) + LIBTAYO* Prostate ca
Slide 16: 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 REGN-COV2 (SARS-CoV-2) REGN3767 (LAG-3) REGN-COV2 (SARS-CoV-2) Dupilumab* (IL-4R) REGN-COV2 (SARS-CoV-2) Cemiplimab* (PD-1) REGN5713-5714-5715 REGN4461 (LEPR) Sarilumab* (IL
Slide 17: Fasinumab: High Risk/High Reward
FASINUMAB: HIGH RISK/HIGH REWARD Osteoarthritis is a common condition associated with wear and tear on the Fasinumab* is a human monoclonal joints, and is the most common antibody that treats osteoarthritis pain indication for knee and hip replacement by blocking nerve growth factor (NGF) • Pain is
Slide 18: How Antibodies Work Against SARS-CoV-2
HOW ANTIBODIES WORK AGAINST SARS-COV-2 SARS-CoV-2 Binding Mechanism With Antibodies… ACE 2 receptor Virus binds to healthy cell receptor in order to infect Spike protein REGN-COV2 Antibodies block the virus’s Spike protein, antibody “cocktail” neutralizing its ability to bind and infect • Regeneron
Slide 19: REGN-COV2 Clinical Pivotal Program
LAUNCHED REGN-COV2 CLINICAL PIVOTAL PROGRAM Treatment: Treatment: Hospitalized Non-hospitalized Clinical development program COVID-19 patients COVID-19 patients expected to enroll thousands in (currently enrolling) (currently enrolling) treatment and prevention studies New manufacturing and supply a
Slide 20: Multiple Potential Regulatory Submissions: 2020-2022+
MULTIPLE POTENTIAL REGULATORY SUBMISSIONS: 2020-2022+ 2020 2021 2022+ REGN-EB3 Fasinumab† REGN1979 (CD20xCD3) DUPIXENT* Ebola Virus Infection (PDUFA 10/25/20) Osteoarthritis Pain B Cell NHL Pediatric Atopic Dermatitis (6 mo-5 yr) Eosinophilic Esophagitis Evinacumab Garetosmab REGN5458 (BCMAxCD3)* Bu
Slide 21: 2020 Key Upcoming Milestones
2020 KEY UPCOMING MILESTONES Dupixent (IL-4/IL-13) Ph3 readout in pediatric asthma (6-11 years) LIBTAYO Regulatory submissions for BCC and 1L NSCLC REGN-COV2 (antibody cocktail) Report efficacy results from COVID-19 clinical program Fasinumab (NGF) Discuss Ph3 long-term safety and efficacy results w
Slide 22: Reconciliation of GAAP Net Income to Non-GAAP Net Income
RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET INCOME TO NON-GAAP NET INCOME (Unaudited) (In millions, except per share data) ® 22 * See slide 2 for additional important information regarding non-GAAP financial measures included in
Regeneron Pharmaceuticals — Investor Presentation (August 2020) on 6ix