Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — JP Morgan Healthcare Conference 2020
34 slides from Regeneron Pharmaceuticals's conference presentation, Jan 13, 2020
Slide 1: JP Morgan 2020 - Regeneron Presidents and CEO/CSO
® ® LEONARD S. SCHLEIFER MD, P h D PRESIDENT & CEO GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO JP MORGAN 2020 JANUARY 13 TH
Slide 2: Note Regarding Forward-Looking Statements and Non-GAAP Financial Measures
® 2 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
Slide 3: A Decade of Innovation, Value Creation, and Transformation
® 3 A DECADE OF INNOVATION, VALUE CREATION, AND TRANSFORMATION 2010 2020 * Includes products marketed by Regeneron and/or its collaborators, based on trailing 12 months ended Sep 30, 2019 † TSR from Jan 1, 2010 through Dec 31, 2019 >1450% Total Shareholder Return † Nasdaq Biotech Index +370% S&P 500
Slide 4: 2019 at a Glance
® 4 2019 AT A GLANCE * As of 3Q19 trailing 12 month basis; Bayer records net product sales of EYLEA outside the U.S. † Based on preliminary unaudited fiscal 2019 results; preliminary unaudited 4Q19 U.S. EYLEA net product sales of $1.22Bn ^ Based on 3Q19 global net product sales as reported by Sanofi
Slide 5: Regeneron's Near-Term Growth Drivers
® REGENERON’S NEAR - TERM GROWTH DRIVERS DR – Diabetic Retinopathy; AD – Atopic Dermatitis; CRSwNP – Chronic Rhinosinusitis with Nasal Polyposis; HoFH – Homozygous familial hypercholesterolemia; FOP – Fibrodysplasia ossificans progressiva 5 • Execute in wet AMD and diabetic eye diseases • Maximize D
Slide 6: EYLEA: Strengthening Market Leadership Position
® EYLEA ® : STRENGTHENING MARKET LEADERSHIP POSITION $0.98 $0.99 $1.02 $1.08 $1.07 $1.16 $1.19 $1.22 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 U.S. Net Product Sales, $Billion 6 U.S. EYLEA Net Product Sales* Y/Y Change 4Q19 $1.22Bn +13% 2019 $4.64Bn +14% * Based on preliminary unaudited fiscal 2019 re
Slide 7: Dupixent: Strong Execution Across Multiple Indications
® $117 $181 $220 $259 $303 $455 $508 $15 $28 $43 $60 $71 $103 $125 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 US ROW 7 DUPIXENT ® : STRONG EXECUTION ACROSS MULTIPLE INDICATIONS WEEKLY NEW TO BRAND ( NBRx ) † † Source: IQVIA National Source of Business 0 200 400 600 800 1,000 1,200 1,400 1,600 Jan-18 Feb-18
Slide 8: Libtayo: Leading Treatment for Advanced CSCC in U.S.
® $15 $27 $41 $48 $4 4Q18 1Q19 2Q19 3Q19 US ROW LIBTAYO ® : LEADING TREATMENT FOR ADVANCED CSCC IN U.S. Net Product Sales*, $Million * Sanofi records net product sales of Libtayo outside the U.S. 8 61% 42% 43% 41% 42% 38% 38% 35% 35% 35% 34% 32% 29% 15% 14% 13% 12% 11% 11% 9% 9% 9% 9% 8% 8% 8% 14% 2
Slide 9: 2019 Key Advancements in Oncology
® 9 2019 KEY ADVANCEMENTS IN ONCOLOGY PD - 1 • Libtayo became the #1 systemic treatment in CSCC • Released promising interim response data for Libtayo vs. chemotherapy in 1L NSCLC BISPECIFICS • Updated REGN1979 (CD20xCD3) data; potentially pivotal Phase 2 study initiated • Presented first - time REG
Slide 10: Maximizing Opportunities Through Targeted Business Development
® 10 MAXIMIZING THE OPPORTUNITIES FOR OUR SCIENCE AND PRODUCT PORTFOLIO THROUGH TARGETED BUSINESS DEVELOPMENT COMPETE Partnering for global development and commercialization Collaborating with the Regeneron Genetics Center • Collaborations to build upon and leverage Regeneron’s technologies and deep
Slide 11: Multiple Potential Regulatory Submissions: 2020-2022+
® MULTIPLE POTENTIAL REGULATORY SUBMISSIONS: 2020 - 2022+ Evinacumab New Molecule New Indication KEY 2020 2021 2022+ 11 Homozygous Familial Hypercholesterolemia REGN - EB3 Ebola Virus Infection DUPIXENT* DUPIXENT* Pediatric Asthma (6 - 11 yr ) LIBTAYO* Basal Cell Carcinoma PRALUENT Homozygous Famili
Slide 12: Ex-U.S. Commercialization Expansion
® 12 COMPETE • Regeneron is in the initial stages of commercial expansion outside of the United States • Exercising our co - commercialization rights for Dupixent outside the U.S. allows for a low risk expansion strategy • The expansion will enable Regeneron to independently commercialize drugs outs
Slide 13: Antibody Agreement Modification
® 13 ANTIBODY AGREEMENT MODIFICATION • Improve profitability • Increase efficiency of Praluent and Kevzara operations • Simplify financial reporting Regeneron Benefits of Anticipated Changes to the Antibody Agreement (Transaction expected to be finalized in 1Q20) • Terms unchanged • Regeneron to hav
Slide 14: Business Summary
® 14 • Significant accomplishments over the last decade have transformed Regeneron into a premier biopharmaceutical company • 2019 was a year of R&D innovation, commercial execution on core EYLEA, Dupixent, and Libtayo franchises and financial performance across the enterprise • Regeneron - Sanofi A
Slide 15: George D. Yancopoulos, President & CSO
® 15 GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO
Slide 16: Regeneron-Invented Technologies Repeatedly Deliver Important New Therapeutics
® TARGET DISCOVERY & VALIDATION – Human & Mouse Genetics – VelociGene ® – VelociMouse ® CLINICAL DEVELOPMENT TECH DEVELOPMENT TURNKEY THERAPEUTICS: TRAPs & ANTIBODIES – TRAPs – VelocImmune ® – VelociMab ® MANUFACTURING MEDICINES REGENERON - INVENTED TECHNOLOGIES REPEATEDLY DELIVER IMPORTANT NEW THER
Slide 17: Regeneron-Invented Technologies Repeatedly Deliver Important New Therapeutics
® TARGET DISCOVERY & VALIDATION – Human & Mouse Genetics – VelociGene ® – VelociMouse ® CLINICAL DEVELOPMENT TECH DEVELOPMENT TURNKEY THERAPEUTICS: TRAPs & ANTIBODIES – TRAPs – VelocImmune ® – VelociMab ® MANUFACTURING MEDICINES REGENERON - INVENTED TECHNOLOGIES REPEATEDLY DELIVER IMPORTANT NEW THER
Slide 18: Regeneron Approaches Can Address Diverse Disease Challenges
® 18 REGENERON APPROACHES CAN ADDRESS DIVERSE DISEASE CHALLENGES: FROM RECENT EXAMPLES… TO CANCER & BEYOND… This slide contains investigational products not yet approved by regulatory authorities • Millions of Americans suffer from cat allergy • Approximately half a million Americans pursue laboriou
Slide 19: Regeneron-Discovered Approved and Investigational Medicines
® Pozelimab (C5) REGN4018* (MUC16xCD3) REGN5458 * (BCMAxCD3) REGN1979 (CD20xCD3) REGENERON - DISCOVERED APPROVED AND INVESTIGATIONAL MEDICINES PHASE 1 PHASE 2 RARE DISEASES REGN4461 (LEPR) Cemiplimab* (PD - 1) REGN4659 (CTLA - 4) REGN3767 (LAG - 3) REGN1908 - 1909 (Feld1) REGN5069 ( GFR α 3 ) Cemipl
Slide 20: Dupixent: Regeneron Technologies Deliver Blockbuster
® 20 DUPIXENT ® : REGENERON TECHNOLOGIES DELIVER BLOCKBUSTER WITH POTENTIAL TO TREAT MULTIPLE ALLERGIC DISEASES For decades, Regeneron scientists worked with, and followed up, the seminal findings of Bill Paul (NIH) with the belief that IL - 4 and IL - 13 might be key mediators of Type 2 inflammator
Slide 21: Dupixent: Delivering on the Pipeline in a Product Promise
® DUPIXENT ® : DELIVERING ON THE “PIPELINE IN A PRODUCT” PROMISE 21 Moderate - to - Severe Atopic Dermatitis x Approved in Adults and Adolescents (12+ years) Moderate - to - Severe Asthma x Approved in Adults and Adolescents (12+ years) Chronic Rhinosinusitis with Nasal Polyps x Approved in Adults A
Slide 22: Oncology Strategy: Compete, Enhance, Extend
® 22 ONCOLOGY STRATEGY: COMPETE , ENHANCE, EXTEND * As of 3Q19, trailing 12 month basis of sales data of approved PD - (L)1 agents COMPETE : Libtayo in tumors “responsive” to PD - 1 checkpoint inhibition (e.g., skin & NCSLC) • PD - (L)1 market: >$20Bn, +49% YoY growth* Patient Benefit Tumor Types CO
Slide 23: Oncology Strategy: Compete, Enhance, Extend
® ENHANCE 23 ONCOLOGY STRATEGY: COMPETE, ENHANCE , EXTEND COMPETE : Libtayo in tumors “responsive” to PD - 1 checkpoint inhibition (e.g., skin & NCSLC) • PD - (L)1 market: >$20Bn, +49% YoY growth* Patient Benefit Tumor Types COMPETE ENHANCE : Even for “responsive” tumors, more than half of patients
Slide 24: Oncology Strategy: Compete, Enhance, Extend
® ENHANCE 24 ONCOLOGY STRATEGY: COMPETE, ENHANCE, EXTEND COMPETE : Libtayo in tumors “responsive” to PD - 1 checkpoint inhibition (e.g., skin & NCSLC) • PD - (L)1 market: >$20Bn, +49% YoY growth* Patient Benefit Tumor Types COMPETE ENHANCE : Even for “responsive” tumors, more than half of patients d
Slide 25: Regeneron Oncology Toolkit Leverages Multiple Platforms
® BiSpecifics 25 REGENERON ONCOLOGY TOOLKIT LEVERAGES MULTIPLE PLATFORMS TO CREATE COMBINATORIAL FLEXIBILITY PD - 1 ( Libtayo ) CD3 BiSpecifics (to link Killer T Cell to tumor: Signal 1) CoStimulatory BiSpecifics (to provide synergistic Signal 2) Partnerships (CAR - Ts; Vaccines) VelocImmune ® Antib
Slide 26: Establish Libtayo as a Foundation in Oncology
® 26 ESTABLISH LIBTAYO AS A FOUNDATION IN ONCOLOGY COMPETE, ENHANCE, and EXTEND treatment benefits in monotherapy and in combination settings COMPETE *ORR – Objective Response Rate; in NSCLC, regulatory authorities do not consider ORR a validated surrogate endpoint CSCC – Cutaneous Squamous Cell Car
Slide 27: Regeneron's Veloci-Bi Approach to Bispecifics
® REGENERON’S VELOCI - BI ® APPROACH CAN CREATE, MANUFACTURE, AND DEVELOP HIGH - QUALITY BISPECIFICS OF ANY DESIRED SPECIFICITY VG – VelociGene ® , VI – VelocImmune ® Costim – CD28 - engaging, costimulatory molecule 27 VELOCI - BI ® • VelociGene ® and VelocImmune ® technologies are fundamental – Fou
Slide 28: Regeneron's CD3 Bispecifics Show Significant Anti-Tumor Activity
® REGENERON’S CD3 BISPECIFICS SHOW SIGNIFICANT ANTI - TUMOR ACTIVITY 28 R/R Follicular Lymphoma • ORR=95%, CR=77% • N=22, doses 5 - 320 mg • mPFS est: 11.4 mo (6.7 - NE) R/R – Relapsed/ Refractory (heavily pre - treated) DLBCL – Diffuse Large B Cell Lymphoma R/R DLBCL (CAR T naïve) • ORR=71%, CR=71%
Slide 29: Costimulatory Bispecifics Show Synergy in Preclinical Tumor Models
® 29 ADDING COSTIMULATORY BISPECIFICS TO CD3 BISPECIFICS OR TO ANTI - PD - 1 SHOWS SYNERGY IN PRECLINICAL TUMOR MODELS • Our CD28 costimulatory BiSpecifics activate T cells only when they are bridged to cancer cells and after having received the first “recognition” signal from the CD3 engagement • U
Slide 30: Breadth of Regeneron's Oncology Pipeline
® BiSpecifics BREADTH OF REGENERON’S ONCOLOGY PIPELINE REFLECTS COMBINATORIAL FLEXIBILITY REGN5458* (BCMAxCD3) Multiple myeloma REGN4659 (CTLA - 4) NSCLC REGN3767 (LAG - 3) Solid/hematologic cancers REGN5678 (PSMAxCD28) Prostate cancer REGN5093 ( METxMET ) MET - altered NSCLC REGN5459* (BCMAxCD3) Mu
Slide 31: Key Upcoming 2020 Milestones
® KEY UPCOMING 2020 MILESTONES KEY DATA READOUTS 31 KEY REGULATORY APPROVALS & SUBMISSIONS Dupixent (IL - 4/IL - 13) Regulatory action for pediatric Atopic Dermatitis (age 6 - 11 years) Evinacumab (ANGPTL3) Regulatory submission for Homozygous Familial Hypercholesterolemia ( HoFH ) REGN - EB3 (Ebola
Slide 32: A Decade of Innovation, Value Creation, and Transformation
® 32 A DECADE OF INNOVATION, VALUE CREATION, AND TRANSFORMATION 2010 2020 * Includes products marketed by Regeneron and/or its collaborators, based on trailing 12 months ended Sep 30, 2019 † TSR from Jan 1, 2010 through Dec 31, 2019 >1450% Total Shareholder Return † Nasdaq Biotech Index +370% S&P 50
Slide 33: Appendix
APPENDIX REGENERON SCIENCE TO MEDICINE
Slide 34: Reconciliation of GAAP Net Income to Non-GAAP Net Income
® RECONCILIATION OF GAAP NET INCOME TO NON - GAAP NET INCOME 34 REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET INCOME TO NON - GAAP NET INCOME (Unaudited) (In millions, except per share data) * See slide 2 for additional important information regarding non - GAAP financial measures inclu
Regeneron Pharmaceuticals — JP Morgan Healthcare Conference 2020 on 6ix