SECURITIES AND EXCHANGE COMMISSION
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Item 2.02. Results of Operations and Financial Condition.
On January 13, 2020, at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco, California (the “2020 J.P. Morgan Healthcare Conference”), Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, are providing a corporate update. The presentation includes information regarding the Company’s preliminary (unaudited) U.S. net product sales of EYLEA® (aflibercept) Injection of approximately $4.64 billion for the full year 2019 (based on preliminary (unaudited) fourth quarter 2019 U.S. net product sales of EYLEA of approximately $1.22 billion).
Item 7.01. Regulation FD Disclosure.
The information set forth under Item 2.02 of this Current Report on Form 8-K is incorporated by reference herein.
On January 13, 2020, at the 2020 J.P. Morgan Healthcare Conference, Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron, and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron, are providing a corporate update. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference in this Item 7.01.
The information included in Item 2.02 and the information included or incorporated in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, nor shall such information and exhibit be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
|99.1||Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., at the 38th Annual J.P. Morgan Healthcare Conference.|
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|REGENERON PHARMACEUTICALS, INC.|
/s/ Joseph J. LaRosa
|Joseph J. LaRosa|
|Executive Vice President, General Counsel and Secretary|
Date: January 13, 2020
® ® LEONARD S. SCHLEIFER MD, P h D PRESIDENT & CEO GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO JP MORGAN 2020 JANUARY 13 TH
® 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 actual events or results may differ materially from these forward - looking statements . Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward - looking statements, although not all forward - looking statements contain these identifying words . These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed by Regeneron and/or its collaborators (collectively, “Regeneron’s Products”) and Regeneron’s product candidates and research and clinical programs now underway or planned, including without limitation EYLEA® (aflibercept) Injection, Dupixent® ( dupilumab ), Libtayo ® (cemiplimab), Praluent ® (alirocumab), Kevzara ® ( sarilumab ), fasinumab , evinacumab , garetosmab , pozelimab , Regeneron’s immuno - oncology programs (including its costimulatory bispecific portfolio), Regeneron’s earlier - stage product candidates, and the use of human genetics in Regeneron’s research programs ; the extent to which the results from Regeneron’s research programs or preclinical testing may lead to advancement of product candidates to clinical trials or therapeutic applications ; unforeseen safety issues resulting from the administration of Regeneron’s Products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s product candidates in clinical trials ; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron’s late - stage product candidates and new indications for Regeneron’s Products including without limitation EYLEA, Dupixent, Libtayo , Praluent , Kevzara , fasinumab , evinacumab , REGN - EB 3 , garetosmab , pozelimab , and REGN 1979 ; the likelihood and timing of achieving any of the anticipated milestones described in this presentation ; the extent to which the results from the research and development programs conducted by Regeneron or its collaborators may be replicated in other studies and lead to therapeutic applications ; ongoing regulatory obligations and oversight impacting Regeneron’s Products (such as EYLEA, Dupixent, Libtayo , Praluent , and Kevzara ), research and clinical programs, and business, including those relating to patient privacy ; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and product candidates ; competing drugs and product candidates that may be superior to Regeneron’s Products and product candidates ; uncertainty of market acceptance and commercial success of Regeneron’s Products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron’s Products and product candidates ; the availability and extent of reimbursement of Regeneron’s Products from third - party payers, including private payer healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid ; coverage and reimbursement determinations by such payers and new policies and procedures adopted by such payers ; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates ; the ability of Regeneron’s collaborators, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and product candidates ; unanticipated expenses ; the costs of developing, producing, and selling products ; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance ; risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to Dupixent and Praluent ), other litigation and other proceedings and government investigations relating to the Company and/or its operations, the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition ; and the potential for any license or collaboration agreement, including Regeneron’s agreements with Sanofi, Bayer, and Teva Pharmaceutical Industries Ltd . (or their respective affiliated companies, as applicable), to be cancelled or terminated without any further product success . A more complete description of these and other material risks can be found in Regeneron’s filings with the U . S . Securities and Exchange Commission, including its Form 10 - K for the fiscal year ended December 31 , 2018 and its Form 10 - Q for the quarterly period ended September 30 , 2019 including in each case in the section thereof captioned “Item 1 A . Risk Factors . ” Any forward - looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward - looking statements made by Regeneron . Regeneron does not undertake any obligation to update publicly any forward - looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise . This presentation uses non - GAAP net income per share, or non - GAAP EPS, which is a financial measure that is not calculated in accordance with U . S . Generally Accepted Accounting Principles (“GAAP”) . This and other non - GAAP financial measures are computed by excluding certain non - cash and other items from the related GAAP financial measure . Non - GAAP adjustments also include the income tax effect of reconciling items . The Company makes such adjustments for items the Company does not view as useful in evaluating its operating performance . For example, adjustments may be made for items that fluctuate from period to period based on factors that are not within the Company’s control, such as the Company’s stock price on the dates share - based grants are issued . Management uses non - GAAP measures for planning, budgeting, forecasting, assessing historical performance, and making financial and operational decisions, and also provides forecasts to investors on this basis . Additionally, non - GAAP measures provide investors with an enhanced understanding of the financial performance of the Company’s core business operations or a perspective on how effectively the Company deploys capital . However, there are limitations in the use of non - GAAP financial measures as they exclude certain expenses that are recurring in nature . Furthermore, the Company’s non - GAAP financial measures may not be comparable with non - GAAP information provided by other companies . Any non - GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial performance prepared in accordance with GAAP . A reconciliation of the Company's third quarter 2019 non - GAAP to GAAP net income per share is provided on slide 34 .
® 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 α 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 naïve) • 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
® 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 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… © Copyright 2020 Regeneron Pharmaceuticals, Inc. All rights reserved.
® 33 APPENDIX
® 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