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LEONARD S. SCHLEIFER MD, P h D PRESIDENT & CEO GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO JP MORGAN 2020 JANUARY 13 TH
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 +256% 7 approved medicines* 18 novel candidates in clinical development ~$10Bn in net product sales of all Regeneron - invented products* ~8,000 employees Ideas realized Even bigger ones coming 1 approved medicine 7 novel candidates in clinical development $18MM in net product sales ~1,000 employees Big ideas
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 # See reconciliation of non - GAAP to GAAP net income per share on slide 34 REGULATORY APPROVALS EYLEA : Diabetic Retinopathy (U.S.), pre - filled syringe (U.S.) Dupixent : Atopic Dermatitis in Adolescents (ages 12 - 17), Chronic Rhinosinusitis with Nasal Polyposis, Severe Asthma (EU) Libtayo : Cutaneous Squamous Cell Carcinoma (EU) CLINICAL ADVANCES COMMERCIAL EXECUTION FINANCIAL EXECUTION Revenue : +19% growth 3Q19 YTD Non - GAAP Diluted EPS # : +7% 3Q19 YTD Business Development : ~$900MM in equity and upfronts $1Bn Share Repurchase Program EYLEA : Global net product sales of ~$7.3Bn*; 4Q19 U.S. EYLEA net product sales grew 13% YoY to $1.22Bn Dupixent : Global net sales annualizing at >$2.5Bn ^ Libtayo : #1 systemic treatment in CSCC in the U.S. Antibody Collaboration with Sanofi : Profitable in 2Q19; increased profitability in 3Q19 Dupixent : Completed Ph3 in Severe Atopic Dermatitis (ages 6 - 11) Libtayo : Ph3 interim ORR readout in Non - Small Cell Lung Cancer REGN1979 (CD20xCD3): Data in Non - Hodgkin Lymphoma REGN5458 (BCMAxCD3): Initial data in Multiple Myeloma REGN - EB3 : Superior to ZMapp in preventing Ebola deaths
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 DR and pre - filled syringe launches Explore high - dose formulation for less frequent dosing Pursue gene therapy and other novel approaches EYLEA Transform the treatment of Type 2 inflammatory diseases Maximize launches in AD, asthma, and CRSwNP Expand to pediatric AD and asthma patients Execute expanded Ph3 development program Dupixent* Oncology Realize potential for best - in - class immunotherapy treatments Compete , Enhance , and Extend benefits of immunotherapy to broader patient populations Specialized growth opportunities: Garetosmab (Activin A) FOP Evinacumab (ANGPTL3) HoFH Pozelimab +/ - siRNA (C5) C5 - mediated diseases Fasinumab (NGF) Osteoarthritis pain This slide contains investigational products not yet approved by regulatory authorities * In collaboration with Sanofi In collaboration with Alnylam
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 results
$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 Mar-18 Apr-18 May-18 Jun-18 Jul-18 Aug-18 Sep-18 Oct-18 Nov-18 Dec-18 Jan-19 Feb-19 Mar-19 Apr-19 May-19 Jun-19 Jul-19 Aug-19 Sep-19 Asthma Launch Adolescent AD Launch Branded AD DTC TV CRSwNP Launch * Sanofi records global net product sales of Dupixent Net Product Sales*, $Million AD - Atopic Dermatitis; CRSwNP - Chronic Rhinosinusitis with Nasal Polyposis
$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% 25% 22% 21% 20% 20% 18% 17% 15% 15% 14% 13% 13% 9% 14% 13% 13% 11% 11% 12% 10% 9% 9% 8% 7% 7% 3% 7% 11% 15% 19% 22% 28% 31% 32% 35% 39% 41% Before Launch Oct'18 Nov'18 Dec'18 Jan'19 Feb'19 Mar'19 Apr'19 May'19 Jun'19 Jul'19 Aug'19 Sept'19 Advanced CSCC - Total Patient Share by Products CSCC - Cutaneous Squamous Cell Carcinoma Source: Updated IQVIA - Claims through Sep'19 Chemo EGFR Keytruda Opdivo PD - L1s Libtayo
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 REGN5458 (BCMAxCD3) data Dosed first patient with REGN5678 (PSMAxCD28) costimulatory BiSpecific Initiated clinical studies with additional BiSpecifics BUSINESS DEVELOPMENT Initiated collaborations with Vyriad , Inc. and BioNTech SE Advanced collaborations with bluebird bio Inc., Adicet Bio Inc., Replimune Group, Inc., and ISA Pharmaceuticals B.V. CSCC - Cutaneous Squamous Cell Carcinoma NSCLC - Non - Small Cell Lung Cancer
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 biological expertise In - licensing external technologies to enable and accelerate our internal discovery efforts Global development and commercial partnerships with other leading biopharma companies Broad strategic relationships with academia, medical centers, and governments 10 Advancing treatments for Ebola, flu, and emerging pathogens Leveraging our biology/genetics and proprietary technology platforms Expanding our therapeutic capabilities Enabling best - in - class IO regimens
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 Familial Hypercholesterolemia LIBTAYO* 2L Cervical Cancer Pediatric Atopic Dermatitis (6 mo - 6 yr ) Eosinophilic Esophagitis Bullous Pemphigoid Chronic Spontaneous Urticaria Allergic Bronchopulmonary Aspergillosis Chronic Obstructive Pulmonary Disease LIBTAYO* 1L Non - Small Cell Lung Cancer REGN5458 (BCMAxCD3)* Relapsed/Refractory Multiple Myeloma PRALUENT Pediatric HeFH * In collaboration with Sanofi In collaboration with Teva and Mitsubishi Tanabe Fasinumab Osteoarthritis Pain Garetosmab FOP ( to be discussed with regulators) Pozelimab C5 - mediated diseases REGN1979 (CD20xCD3) B Cell NHL DUPIXENT* Prurigo Nodularis High - Dose EYLEA Wet AMD and DME This slide contains investigational products not yet approved by regulatory authorities
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 outside the U.S. and maximize the value of our pipeline EX - U.S. COMMERCIALIZATION EXPANSION
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 have sole U.S. rights Sanofi to have sole ex - U.S. rights; Regeneron to receive royalties on ex - U.S. net sales Sanofi to have sole global rights Regeneron to receive royalties on global net sales
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 Antibody Collaboration profitability continues to improve o Collaboration enhances revenue and earnings diversification o Agreement modification leading to further profitability and leverage Entering 2020 with momentum for continued long - term growth BUSINESS SUMMARY
15 GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO
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 THERAPEUTICS 16 REGENERON technologies deliver repeated breakthroughs by addressing limitations and bottlenecks in every step of the drug discovery 2010 - 2020: EYLEA DUPIXENT PRALUENT LIBTAYO 2020 + REGN3500 (IL - 33) Garetosmab Evinacumab REGN - EB3 Others This slide contains investigational products not yet approved by regulatory authorities EHR - Electronic Health Records; PiG - Peptide - in - Groove
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 THERAPEUTICS 17 REGENERON technologies deliver repeated breakthroughs by addressing limitations and bottlenecks in every step of the drug discovery 2010 - 2020: EYLEA DUPIXENT PRALUENT LIBTAYO 2020 + REGN3500 (IL - 33) Garetosmab Evinacumab REGN - EB3 Others This slide contains investigational products not yet approved by regulatory authorities - World leading human sequencing .over 1MM humans sequenced .linked to EHRs .BIG DATA NEW THERAPEUTICS APPROACHES: BiSpecifics : CD3, CoStims , PiGs siRNA: with Alnylam Cell & Viral Gene Therapy , Others EHR - Electronic Health Records; PiG - Peptide - in - Groove
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 laborious allergy desensitization with questionable efficacy Anti - Feld1 markedly improved symptoms, and the responses lasted at least one month* Ongoing Ph2 study of benefits in cat allergen triggered asthma Ebola outbreak in 2014 caused BARDA to ask for pharmaceutical companies to help Regeneron developed a 3 - antibody cocktail ; ready for clinic in just 6 months In August 2019, PALM study stopped early as REGN - EB3 was superior to standard of care Ebola example demonstrates Regeneron's ability to swiftly deliver important solutions for emerging epidemics Devastating orphan disease in which muscles, tendons and ligaments are progressively replaced by bone Phase 2 study showed ~90% reduction in formation of new lesions Validates Regeneron hypothesis that Activin - A drives progression Garetosmab (anti - Activin A) for Fibrodysplasia Ossificans Progressiva (FOP) REGN - EB3 for Ebola Anti - Feld1 for Cat Allergy *Orengo et al., Nat Commun. 2018 Apr 12;9(1):1421
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 3 ) Cemiplimab* (PD - 1) REGN3500* (IL - 33) Dupilumab * (IL - 4R) Sarilumab* ( IL - 6R) Alirocumab* (PCSK9 ) Cemiplimab* (PD - 1) Dupilumab* (IL - 4R) Sarilumab* (IL - 6R) Fasinumab (NGF) PHASE 3 Evinacumab (ANGPTL3) Garetosmab (Activin - A) Evinacumab (ANGPTL3) CARDIOVASCULAR/ METABOLIC DISEASES ONCOLOGY INFECTIOUS DISEASES OPHTHALMOLOGY PAIN IMMUNOLOGY & INFLAMMATORY DISEASES 19 REGN - EB3 (Ebola virus) REGN5713 - 5714 - 5715 (Betv1) REGN5678 (PSMAxCD28) Aflibercept (VEGF Trap) REGN1979 (CD20xCD3) REGN5459* (BCMAxCD3) REGN5093 ( METxMET ) Aflibercept (VEGF Trap) This slide contains investigational products not yet approved by regulatory authorities * In collaboration with Sanofi In collaboration with Teva and Mitsubishi Tanabe
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 inflammatory/ allergic diseases. Regeneron utilized our VelociGene and VelocImmune technologies to validate target, and to invent Dupixent as a potential therapeutic. Dupixent clinical trials prove that IL - 4 and IL - 13 are key drivers of multiple Type 2 inflammatory/ allergic diseases, regardless of the tissue. Chronic Rhinosinusitis with Nasal Polyps Atopic Dermatitis Bullous Pemphigoid Prurigo Nodularis Chronic Spontaneous Urticaria Asthma Allergic Bronchopulmonary Aspergillosis Chronic Obstructive Pulmonary Disease Eosinophilic Esophagitis This slide contains investigational indications not yet approved by regulatory authorities
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 Atopic Dermatitis in Pediatrics (6 months - 5 years) Ph2/3 ongoing Airborne Allergies Ph2 in Grass Allergy completed Food Allergies Ph2 in Peanut Allergy ongoing Additional Indications Prurigo Nodularis (Ph3 initiated 4Q19), Chronic Spontaneous Urticaria (Ph3 initiated 4Q19), Bullous Pemphigoid, and other indications US APPROVED INDICATIONS* NEAR - TERM OPPORTUNITIES LONGER - TERM OPPORTUNITIES Atopic Dermatitis in Pediatrics (6 - 11 years) Regulatory package submitted at end of 2019 Eosinophilic Esophagitis Ph3 ongoing Chronic Obstructive Pulmonary Disease (COPD) Ph3 ongoing Asthma in Pediatrics (6 - 11 years) Ph3 ongoing * In the EU, Dupixent is approved in three indications: moderate - to - severe Atopic Dermatitis, severe Asthma, and severe Chronic Rhinosinusitis with Nasal Polyps This slide contains investigational indications not yet approved by regulatory authorities
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 COMPETE Oncology Opportunity
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 do not respond to IO treatment Studying addition of novel therapeutics to Libtayo to " enhance " responsiveness for these tumors Oncology Opportunity * As of 3Q19, trailing 12 month basis of sales data of approved PD - (L)1 agents
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 do not respond to IO treatment Studying addition of novel therapeutics to Libtayo to " enhance " responsiveness for these tumors EXTEND : For tumor settings with limited response to checkpoint inhibition Novel therapeutics to " extend " responsiveness to these tumor settings - e.g., BiSpecifics EXTEND Oncology Opportunity * As of 3Q19, trailing 12 month basis of sales data of approved PD - (L)1 agents
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 Antibodies (e.g. checkpoint inhibitors) New Classes of BiSpecifics PiGs , VelociNator TM , others
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 Carcinoma; BCC - Basal Cell Carcinoma; NSCLC - Non - Small Cell Lung Cancer NSCLC Monotherapy study preliminary investigator - read response data N=361 Libtayo Chemo ORR 42% 22% First PD - (L)1 approval for advanced CSCC: >40% ORR From Ph1 trial initiation to FDA approval: ~3.5 years CSCC: Fast to market Moving to earlier lines of therapy and to other skin cancers: CSCC: - Neoadjuvant pilot has 70% ORR with 55% CRs - larger study initiating - Adjuvant CSCC trial started Advanced BCC: Registrational study reading out 2020 Expand dermato - oncology Become competitive in the major anti - PD - 1 opportunity, i.e. Lung Cancer: Libtayo monotherapy in PD - L1 - high 1L NSCLC: - Encouraging ORR compared to chemotherapy (see table) - Next overall survival interim analysis in 2020 2 nd Ph3 study in combination with chemotherapy: full enrollment in 2H20 Position in NSCLC Combine with BiSpecifics etc. Enhance and Extend responsiveness to anti - PD - 1 class: Combinations with CD3 and CD28 BiSpecifics as well as other immunomodulatory antibodies Novel combinations with vaccines and other modalities This slide contains investigational products not yet approved by regulatory authorities
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 - Foundation for Dupixent , Praluent , Libtayo , and other Regeneron - discovered medicines Next - generation VelocImmune makes several distinct classes of BiSpecifics , with varying specificity and affinity Regeneron BiSpecific approach is unique - No linkers or artificial sequences - Ease of manufacturing using same process as regular antibodies - Similar PK to regular antibodies T cell activators T cell costims Anti - CD3 Anti - CD28 CD20 BCMA MUC16 PSMA Others Tumor Cell Tumor Cell Killer T Cell Killer T Cell "Signal 1" "Signal 2"
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 na ve) ORR=71%, CR=71% N=7, doses 80 - 320 mg ORR=50%, CR=25% N=12, doses 80 - 320 mg R/R DLBCL (post - CAR T) N=7, doses 3 - 6 mg At 6mg dose (n=4): - ORR=3/4 patients (75%) - MRD - neg=2/4 patients (50%) R/R Multiple Myeloma Dose escalation ongoing American Society of Hematology (ASH) - December 2019 REGN1979 Anti - CD3 Anti - CD20 REGN5458 Anti - CD3 Anti - BCMA REGN1979 links CD20 on tumor cells to CD3 on killer T cells - First BiSpecific in our portfolio: required careful approach to safely escalate doses of a potent immunostimulatory agent to provide benefit to patients Encouraging data seen with REGN5458 (BCMAxCD3) in early dose cohorts Median of 7 lines of prior systemic therapy, including anti - CD38 Patients with primarily medullary and secretory disease This slide contains investigational products not yet approved by regulatory authorities MRD - Minimal Residual Disease
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 Unlike CD28 superagonists , CD28 costims did not induce cytokine storm as monotherapy or in combination in our animal models anti - PD - 1 + PSMAxCD28 syngeneic humanized prostate cancer mouse model MUC16xCD3 + MUC16xCD28 xenogeneic ovarian tumor mouse model EGFRvIIIxCD3 xCD3 MUC16xCD28 MUC16xCD3 + MUC16xCD28 MUC16xCD3 0 5 10 15 20 25 0 500 1000 1500 2000 Days Post Implant T u m o r V o l u m e ( m m 3 ) Isotype PSMA x CD28 PD1 PSMA x CD28 + PD1 *** anti - PD - 1 Control anti - PD - 1 + PSMAxCD28 PSMAxCD28 MUC16xCD28 MUC16xCD3 MUC16xCD3 + MUC16xCD28 EGFRvIII xCD3 (control) This slide contains investigational products not yet approved by regulatory authorities In 2019, first - in - class costim PSMAxCD28 entered clinical development; planning to advance several other CD28 BiSpecific antibodies into the clinic in 2020
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) Multiple myeloma REGN4018* (MUC16xCD3) Ovarian cancer GITR Solid tumors PiG (Peptide in HLA Groove) Solid tumors 30 * In collaboration with Sanofi Preclinical REGN1979 (CD20xCD3) B cell NHL RP1 + Libtayo ( Replimune ) CSCC ISA101b + Libtayo (ISA) HNSCC Voyager - V1 + Libtayo ( Vyriad ) Solid tumors Libtayo * CSCC Libtayo * NSCLC Libtayo * BCC Libtayo * Cervical Libtayo * Adjuvant CSCC This slide contains investigational products not yet approved by regulatory authorities VelocImmune Antibodies CD3 BiSpecifics BiSpecifics Partnerships Costims New classes Additional BiSpecifics and combinations expected to enter the clinic in 2020 EARLY DEVELOPMENT POTENTIALLY PIVOTAL APPROVED
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) Complete rolling BLA submission for Ebola; regulatory action Garetosmab (Activin - A) Regulatory submission for Fibrodysplasia Ossificans Progressiva (FOP) Libtayo (PD - 1) Ph3 OS interim analysis in 1L NSCLC Ph2 pivotal study in advanced Basal Cell Carcinoma Dupixent (IL - 4/IL - 13) Ph3 study in pediatric Asthma (ages 6 - 11 years) Ph2 portion of the Ph2/3 study in Eosinophilic Esophagitis ( EoE ) Ph2 study in Peanut Allergy (with Aimmune ) Fasinumab (NGF) Ph3 long - term safety and efficacy studies Pozelimab (C5) Interim results from Ph2 study in Paroxysmal Nocturnal Hemoglobinuria (PNH) REGN1979 (CD20xCD3) and REGN5458 (BCMAxCD3) Updated results from first - in - human studies This slide contains investigational products not yet approved by regulatory authorities
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 included in this presentation