UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of
the Securities Exchange Act of 1934
Date of Report (Date of earliest event
reported): January 11, 2021 (
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
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(I.R.S. Employer Identification No.)
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instructions A.2. below):
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| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
| Item 2.02. | Results of Operations and Financial Condition. |
On January 11, 2021, at the virtual 39th Annual 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 $4.95 billion for the full year 2020 (based on preliminary (unaudited) fourth quarter 2020 U.S. net product sales of EYLEA of approximately $1.34 billion). Overall distributor inventory levels for EYLEA in the United States remained within the Company’s one-to-two-week targeted range.
The presentation also includes information regarding the Company’s preliminary (unaudited) U.S. net product sales of casirivimab and imdevimab, the Company’s novel investigational dual-antibody therapy for COVID-19, of approximately $184 million for the full year 2020 (based on preliminary (unaudited) fourth quarter 2020 U.S. net product sales of casirivimab and imdevimab of approximately $144 million). The Company expects that the full 300,000 doses under the previously announced contract with the U.S. government will be fulfilled by the end of February 2021.
| 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. A copy of the presentation referenced in Item 2.02 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. |
(d) Exhibits.
Note Regarding Forward-Looking Statements
This Current Report on Form 8-K (this “Report”) 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, whether and to what extent Regeneron will be able to supply the remaining doses of the casirivimab and imdevimab antibody cocktail under the terms of the agreement with U.S. government referenced in this Report (the “Manufacturing and Supply Agreement”), the amount of future payments (if any) Regeneron may receive pursuant to the Manufacturing and Supply Agreement, and whether the Manufacturing and Supply Agreement is terminated by the U.S. government or otherwise prior to completion; and 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, including the casirivimab and imdevimab antibody cocktail. 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 year ended December 31, 2019 and its Form 10-Q for the quarterly period ended September 30, 2020. 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 or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.
SIGNATURES
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. | |
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/s/ Joseph J. LaRosa | |
| Joseph J. LaRosa | |
| Executive Vice President, General Counsel and Secretary |
Date: January 11, 2021
Exhibit 99.1
LEONARD S. SCHLEIFER MD, P h D PRESIDENT & CEO GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO JP MORGAN 2021 JANUARY 11 TH
74;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 impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators (collectively, "Regeneron’s Products"), and the global economy; the nature, timing, and possible success and therapeutic applications of 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), InmazebTM (atoltivimab, maftivimab, and odesivimab-ebgn), casirivimab and imdevimab, fasinumab, evinacumab, garetosmab, Regeneron’s and its collaborators’ other oncology programs (including odronextamab (REGN1979) and REGN5458), Regeneron’s and its collaborators’ other hematology programs (including pozelimab (REGN3918)), Regeneron’s and its collaborators’ earlier-stage programs, and the use of human genetics in Regeneron’s research programs; 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 Products and product candidates in clinical trials; the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s product candidates and new indications for Regeneron’s Products including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, casirivimab and imdevimab, fasinumab, evinacumab, garetosmab, odronextamab, REGN5458, and pozelimab; 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 and/or its collaborators may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; 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, or more cost effective than, 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 payors, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid (including the impact of the recently issued “most-favored-nation” interim final rule); coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors; 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, including, without limitation, capital expenditures, 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 EYLEA, 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), as well as Regeneron's agreement with Roche relating to casirivimab and imdevimab, to be cancelled or terminated. 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, 2019 and Form 10-Q for the quarterly period ended September 30, 2020, in each case in the section thereof captioned “Item 1A. 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 or otherwise) 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 non-GAAP to GAAP net income and net income per share for the three months and nine months ended September 30, 2020 is provided on slide 38.
74; Leonard S. Schleifer MD, PhD President & Chief Executive Officer 3
4 $',9(56,),('*52:7+6725< Dupixent in pivotal trials for eight Type 2 diseases Advancing immuno - oncology pipeline and combinations Therapeutic candidates in clinical development A Broad and Diverse Pipeline Strong and Growing Core Brands Entering a Period of New Launches 1L Non - Small Cell Lung Cancer and Basal Cell Carcinoma Pediatric Asthma Homozygous Familial Hypercholesterolemia ( HoFH ) 9; 4; This slide contains investigational products not yet approved by regulatory authorities Evinacumab COVID - 19 Casirivimab / Imdevimab
STRONG EXECUTION IN 2020 Total Revenues (9 months through Sept 2020)* * Year - over - year growth, first nine months of 2020 vs. first nine months of 2019. See reconciliation of non - GAAP net income to GAAP net income and non - GAAP EPS to GAAP EPS on slide 38 1RQ 6; *$$3(361; PRQWKVWKURXJK6HSW 9;9; 2;3; R&D Pipeline Advancements +29% growth +28% growth Eight new INDs EoE , Pediatric Asthma/AD Filed in 1L NSCLC and BCC (PDUFA’s 1Q21) COVID - 19 antibody cocktail EUA )'$ 6; DSSURYHG 7UHDWPHQWIRU(EROD Casirivimab / Imdevimab EoE – Eosinophilic Esophagitis; AD – Atopic Dermatitis; BCC – Basal Cell Carcinoma; NSCLC – Non - Small Cell Lung Cancer; EUA – Emergency Use Authorization; IND – Investigational New Drug; PDUFA – Prescription Drug User Fee Act This slide contains investigational products not yet approved by regulatory authorities Leading CD3 & CD28 Bispecifics platform 5
EYLEA, DUPIXENT, AND LIBTAYO ARE CORE TO DIVERSIFIED GROWTH STRATEGY; SPECIALIZED PROGRAMS OFFER ADDITIONAL GROWTH POTENTIAL 6 35; ([HFXWHDQGJURZLQZHW $0'DQGGLDEHWLFH\H GLVHDVHV 35; ([SORUHKLJK 6; GRVH IRUPXODWLRQIRUOHVV IUHTXHQWGRVLQJ 35; 3XUVXHJHQHWKHUDS\DQG RWKHUQRYHODSSURDFKHV EYLEA • Transform treatment of Type 2 inflammatory diseases • Realize full potential in AD, asthma and CRSwNP • Execute broad Ph3 & Ph4 development program Dupixent* Oncology • Realize potential for best - in - class immunotherapy treatments • Compete , Enhance , and Extend benefits of immunotherapy to broader patient populations This slide contains investigational products not yet approved by regulatory authorities * In collaboration with Sanofi ^ In collaboration with Roche 6SHFLDOL]HGJURZWK RSSRUWXQLWLHV Allergic Disease Cat, Birch Rare Disease HoFH , C5 - mediated diseases Infectious Disease COVID - 19 ^ & Ebola Antibody Cocktails AMD – Age - Related Macular Degeneration; AD – Atopic Dermatitis; CRSwNP – Chronic Rhinosinusitis with Nasal Polyposis; HoFH – Homozygous familial hypercholesterolemia
EYLEA 74; : EXTENDING MARKET LEADERSHIP POSITION Setting a high bar on efficacy/safety/convenience for current and future potential competition Capturing Market Growth ▪ 4Q20 $1.34Bn ( +10% YoY), FY2020 $4.95Bn (+7% YoY)* ▪ Market share gains and favorable demographic trends Focusing on the Science ▪ Explore high - dose formulation for less frequent dosing ▪ Pursue gene therapy and other novel approaches Maximize Growth Initiatives ▪ Realize potential in diabetic eye diseases ▪ Initiating DTC to drive disease awareness #1 prescribed anti - VEGF treatment 30+ million doses administered since launch * U.S. net product sales, Based on preliminary unaudited fiscal 2020 results of $4.95Bn; preliminary unaudited 4Q 2020 U.S. E YLE A net product sales of $1.34Bn $3.3 $3.7 7; $4.6 $4.9 2016 2017 2018 2019 2020* U.S. Net Product Sales, $Billion
$508 $605 $770 $851 $125 $146 $176 $175 $221 4 4Q19 1Q20 2Q20 3Q20 U.S. ROW 8 DUPIXENT 74; : STRONG GROWTH TRAJECTORY * Sanofi records global net product sales of Dupixent 1HW3URGXFW6DOHV3;5;0LOOLRQ Broad - based growth across all approved indications Significant market opportunities support future growth Advancing clinical development program across EIGHT Type 2 diseases +69% worldwide sales growth in 3Q20 vs. 3Q19
9 DUPIXENT 74; : DRIVING LEVERAGE IN COLLABORATION PROFITABILITY * Share of profits/(losses) are derived from global net product sales of Praluent (up until and including 1Q20), Kevzara, an d D upixent, which are recorded by Sanofi ($100) ($50) $0 $50 $100 $150 $200 $250 1Q18 2Q18 3Q18 4Q18 1Q19 2Q19 3Q19 4Q19 1Q20 2Q20 3Q20 Antibody Collaboration Share of Profits / (Losses)* (in Millions)
SUBSTANTIAL PATIENT OPPORTUNITY IN TYPE 2 INFLAMMATORY DISEASES FOR DUPIXENT 74; $VWKPD CRSwNP 2023+e Up to 4M+ Eligible Patients in U.S. by 2023 CRSwNP – Chronic Rhinosinusitis with Nasal Polyposis; COPD – Chronic Obstructive Pulmonary Disease; CSsNP – Chronic Sinusitis without Nasal Polyposis This slide contains investigational indications not yet approved by regulatory authorities Figures represent U.S. Biologic - eligible target population (all age groups) *Target population includes age groups that are not currently approved but in clinical development Source – Regeneron Internal Epidemiology Data Eosinophilic Esophagitis &KURQLF 6SRQWDQHRXV 8UWLFDULD Chronic Inducible Urticaria - Cold Type 2 COPD Prurigo Nodularis Bullous Pemphigoid CSsNP Allergic Fungal Rhinosinusitis 2.3M* N 48k 308k 25k 300k 130k 27k 11k $SSURYHG,QGLFDWLRQV Potential indications with POC Other investigational uses Since launch, ~190k patients in the U.S. have been prescribed Dupixent (~6% market penetration to date) There remains a substantial opportunity for more patients to benefit 975k* 90k 10 2022e 9; H Atopic Dermatitis
74; 11 ROADMAP TO LEADERSHIP IN ONCOLOGY COMPETE , ENHANCE, and EXTEND treatment benefits in monotherapy and in combination settings CSCC – Cutaneous Squamous Cell Carcinoma; BCC – Basal Cell Carcinoma; NSCLC – Non - Small Cell Lung Cancer &203(7( First approved anti - PD - 1 in advanced CSCC Accepted for priority review as first - in - class PD - 1 in 2L+ BCC (PDUFA 3/3/21) $27 $41 $48 $61 $62 $63 $14 $13 $17 $25 1Q19 2Q19 3Q19 4 1Q20 2Q20 3Q20 U.S. ROW Net Product Sales*, $Million * Sanofi records net product sales of LIBTAYO outside the U.S. Accepted for priority review in PD - L1+ NSCLC (PDUFA 2/28/21) COMPETE in 1L Non - Small Cell Lung Cancer /($'LQGHUPDWR 6; RQFRORJ\ This slide contains investigational indications not yet approved by regulatory authorities
74; Regeneron’s clinical development pipeline of 12+ candidates has potential to address unmet need in the vast majority of the most prevalent cancer types 12 SIGNIFICANT OPPORTUNITY TO ENHANCE & EXTEND TREATMENT BENEFITS Even for those cancers that are responsive, many patients unfortunately do not benefit Despite the advancements in the field, there are many cancers that don’t respond to anti PD - 1 monotherapy 0 500,000 1,000,000 1,500,000 2,000,000 2,500,000 * Multiple Myeloma Laryngeal * Brain & CNS * Ovary Melanoma Lip & Oral Cavity Endometrium Kidney * Leukemia * Pancreatic * Non-Hodgkin Lymphoma Bladder * Thyroid Esophagus Cervix Liver Stomach * Prostate * Colorectal Lung * Breast Number of Cancer Cases Per Year Mortality Incidence Source: The Global Cancer Observatory November 2020 * Cancers where anti - PD - 1 treatments have limited or no approval
COVID - 19 ANTIBODY COCKTAIL – FIRST COMBINATION THERAPY TO RECEIV E EUA; MANUFACTURING SCALE - UP ONGOING 13 ,Q 4 9; 5; WKH87;67;)'$JUDQWHG(PHUJHQF\ 8VH$XWKRUL]DWLRQWRWKH&29,' 6; DQWLERG\ FRFNWDLO FDVLULYLPDE DQG LPGHYLPDE Casirivimab and imdevimab is an investigational medicine. The safety and efficacy of this drug candidate are still being evaluated by regulatory authorities. Patients • For recently diagnosed, mild - to - moderate COVID - 19 in high - risk patients Supply/Manufacturing • U.S. government purchased initial 300K doses • Increasing global capacity including through Roche collaboration Clinical Development • Trials in both treatment and prophylactic settings ongoing, exploring lower doses Casirivimab and imdevimab antibody cocktail * Based on preliminary unaudited fiscal 2020 results Net Product Sales • 4Q20 Net Product Sales* of $144M ( $184M in FY2020)
$GGUHVV8QPHW1HHGLQ3DWLHQWVZLWK +R)+ Build Rare Disease Strategy Apply Cardiometabolic Expertise EVINACUMAB – RARE DISEASE OPPORTUNITY 14 Evinacumab is an investigational medicine. The safety and efficacy of this drug candidate are still being evaluated by regulatory authorities. HoFH - Homozygous Familial Hypercholesterolemia PDUFA date 2/11/2021 )RXQGWKDWSDWLHQWVZLWKORVV 6; RI 6; IXQFWLRQPXWDWLRQVLQWKHLU$1*37/ JHQHKDYHVLJQLILFDQWO\ ORZHUOHYHOVRINH\EORRGOLSLGV5;LQFOXGLQJ/'/ 6; & (YLQDFXPDE ZDVGHVLJQHGWRUHSOLFDWHWKLVORVV 6; RI 6; IXQFWLRQPXWDWLRQHIIHFWWRORZHU/'/ 6; &LQ SDWLHQWVZLWK+R)+ Evinacumab
* In collaboration with Sanofi ^ Partial clinical hold pending review of additional data ^^ Partial clinical hold pending changes to clinical protocol + In collaboration with Alnylam † In collaboration with Teva and Mitsubishi Tanabe ‡ Received EUA from FDA for mild to moderate COVID - 19 in high - risk non - hospitalized patients MULTIPLE POTENTIAL REGULATORY SUBMISSIONS: 2021 - 2023+ New Molecule New Indication 2021 2023+ 9; 15 DUPIXENT* Pediatric Asthma (6 - 11 yr ) DUPIXENT* Bullous Pemphigoid Chronic Obstructive Pulmonary Disease Chronic Sinusitis w/o Nasal Polyposis Allergic Fungal Rhinosinusitis REGN5458 (BCMAxCD3)* Relapsed/Refractory Multiple Myeloma )DVLQXPDE 30; Osteoarthritis Pain ^ Garetosmab FOP ^ Odronextemab ^^ (CD20xCD3) B Cell NHL DUPIXENT* Prurigo Nodularis +LJK 6; 'RVH(</($ Wet AMD and DME HeFH – Heterozygous Familial Hypercholesterolemia; FOP – Fibrodysplasia ossificans progressive This slide contains investigational products not yet approved by regulatory authorities COVID - 19 ‡ Casirivimab and Imdevimab LIBTAYO* 2L Cervical Cancer LIBTAYO* + chemo /1RQ 6; 6PDOO&HOO/XQJ&DQFHU Chronic Obstructive Pulmonary Disease Itepekimab (IL - 33)* PRALUENT Pediatric HeFH REGN1908 - 1909 (Feld1) Cat Allergy REGN5713 - 5714 - 5715 (Betv1) %LUFK$OOHUJ\ DUPIXENT* Eosinophilic Esophagitis DUPIXENT* Pediatric Atopic Dermatitis (6 mo - 5 yr ) DUPIXENT* Chronic Inducible Urticaria – Cold DUPIXENT* &KURQLF6SRQWDQHRXV8UWLFDULD Pozelimab 77; cemdisiran + C5 - mediated diseases
16 • 2020 was a transformational year driven by growth , commercial execution across the portfolio, advancements/innovations in R&D , strong financial performance and significant corporate initiatives creating long - term value for shareholders • We will maintain commitment to continue the fight against COVID - 19 • We are entering a period of anticipated accelerated growth with several launches • We continue to advance our industry - leading R&D pipeline and capabilities across many therapeutic areas including oncology and immunology %86,1(666800$5<
74; George D. Yancopoulos, MD, PhD President & Chief Scientific Officer 17
18 9(/2&,*(1( 38; 9(/2&,0286( 38; 9(/2&,0081( 38; 9(/2&,0$% 38; VelociT TM 9(/2&,+80 38; 9(/2&, 6; %L 38; Protein Expression Sciences Rubine / Marigold / Blue (Late 2016) Protein Expression Sciences Rubine / Marigold / White (Late 2016) Protein Expression Sciences Rubine / Invert White Fill (Late 2016) 5(*(1(521WHFKQRORJLHV GHOLYHUUHSHDWHGEUHDNWKURXJKV E\DGGUHVVLQJOLPLWDWLRQVDQGERWWOHQHFNVLQHYHU\VWHSRIWKHGUXJGLVFRYHU\ TECH DEVELOPMENT 7$5*(7 ',6&29(5< 9$/,'$7,21 0$18)$&785,1* &/,1,&$/ '(9(/230(17 MEDICINES 7851.(< 7+(5$3(87,&6 75$3V $17,%2',(6 5(*(1(52182;6 35235,(7$5<7(&+12/2*,(65(3($7('/<'(/,9(5 ,03257$171(:7+(5$3(87,&6
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38; (1+$1&( 21&2/2*<675$7(*<$63,5(72&203(7( 5; (1+$1&( 5; (;7(1' &203(7( EXTEND : Most tumor settings have limited responses to checkpoint inhibition • Extend responsiveness for these tumors via addition of novel therapeutics (e.g., xCD3 & xCD28 Bispecifics ) (;7(1' 7XPRU7\SHV 2QFRORJ\2SSRUWXQLW\ 25 3DWLHQW%HQHILW (1+$1& ( (YHQIRU3' 6; UHVSRQVLYHWXPRUV5; PRUHWKDQKDOIRISDWLHQWVGRQRWUHVSRQG 35; (QKDQFH UHVSRQVLYHQHVVIRUWKHVHWXPRUVE\DGGLQJ QRYHOWKHUDSHXWLFV1;H7;J7;5;[&' [&' %LVSHFLILFV 2; &203(7( /,%7$<2 GHOLYHUVSRWHQWLDOO\ 81;EHVW 6; LQ 6; FODVV82;GDWDLQWXPRUVUHVSRQVLYHWR3' 6; PRQRWKHUDS\1;H7;J7;5;VNLQFDQFHUV 16&/&3;2; 35; &RPSHWH LQODUJH3' 6; 1;/2; RSSRUWXQLW\ R ! %Q5;4; <R<JURZWK A *If approved; under priority review with PDUFA date of 02/28/2021 The use of LIBTAYO in any indication other than advanced CSCC is investigational and has not been fully evaluated by regulatory authorities A%DVHGRQ770QHWSURGXFWVDOHVGDWDIRUDSSURYHG3' 6; 1;/2; DJHQWVDVRI6HSW 9; 5; 9;9;
38; 5(*(1(52121&2/2*<722/.,7/(9(5$*(608/7,3/(3/$7)250672 &5($7(&20%,1$725,$/)/(;,%,/,7< Bispecifics 3' 6; 1;/,%7$<22; &' %LVSHFLILFV 1;WROLQN.LOOHU7&HOOWR WXPRU6LJQDO 2; &RVWLPXODWRU\ %LVSHFLILFV 1;WRSURYLGH V\QHUJLVWLF6LJQDO 2; Collaborations (CAR - Ts; Vaccines) 9HORF,PPXQH 38; $QWLERGLHV 1;H7;J7;5;FKHFNSRLQW LQKLELWRUV2; 1HZ&ODVVHVRI %LVSHFLILFV 3L*V 5; 9HORFL1DWRU 70 5; RWKHUV Our bispecific antibodies are investigational and have not been fully evaluated by regulatory authorities.
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38; COSTIMS COMBINED WITH CD3 BISPECIFICS SHOW ENHANCEMENT IN PRECLINICAL HEMATOLOGICAL TUMOR MODELS 7KLVVOLGHFRQWDLQVLQYHVWLJDWLRQDOSURGXFWVQRW\HWDSSURYHGE\UHJXODWRU\DXWKRULWLHV 2XU&' FRVWLPXODWRU\ELVSHFLILFV DFWLYDWH7FHOOVRQO\ZKHQWKH\DUH EULGJHGWRFDQFHUFHOOVDQGDIWHU KDYLQJUHFHLYHGWKHILUVW79;UHFRJQLWLRQ80; VLJQDOIURPWKH&' HQJDJHPHQW 9; 1;%FHOO7$$2;[&' 4; RGURQH[WDPDE WRHQWHUFOLQLFIRU % 6; 1+/ odronextamab + TAAxCD28 costim odronextamab - resistant DLBCL mouse model &' 9; [&' &' 9; [&' 4;7$$[&' 7$$[&' ,VRW\SHFRQWURO 9; 1;3ODVPDFHOO7$$2;[&' 4; 5(*1 WRHQWHUFOLQLFIRU 0XOWLSOH0\HORPD Complementary costimulatory bispecifics could further enhance anti - tumor effects of odronextamab and REGN5458
38; &267,0 &20%,1$7,216(1+$1&($1'(;7(1'%(1(),762)&+(&.32,17 ,1+,%,7256 This slide contains investigational products not yet approved by regulatory authorities 5(*1 1;360$[&' 2; (YDOXDWLQJFRPELQDWLRQZLWK /,%7$<2 3URVWDWH&DQFHU 1;PHWDVWDWLFFDVWUDWLRQ 6; UHVLVWDQW2; 5(*1 1;08& [&' 2; (YDOXDWLQJFRPELQDWLRQZLWKHLWKHU 08& [&' RU /,%7$<2 2YDULDQ&DQFHU1;UHFXUUHQW2; 5(*1 9; 1;(*)5[&' 2; (YDOXDWLQJFRPELQDWLRQZLWK /,%7$<2 6ROLGWXPRUV5;LQFOXGLQJ 1RQ 6; 6PDOO&HOO/XQJ&DQFHU &XWDQHRXV6TXDPRXV&HOO&DUFLQRPD &RORUHFWDO&DQFHU1;PLFURVDWHOOLWHVWDEOH2; 7ULSOH1HJDWLYH%UHDVW&DQFHU Combinations of our CD3 and CD28 bispecific antibodies and checkpoint inhibitors offer advantage of simultaneously providing multiple signals for activating T cells to kill tumors Additional CD3 and CD28 bispecifics for all these tumors are being developed Robust combinatorial potential and flexibility to enhance and extend treatment across many different types of cancers &' &267,06,17+(&/,1,&1;62/,'7802562;
74; Bispecifics Costims New Classes Collaborations 9HORF,PPXQH 38; $QWLERGLHV CD3 Bispecifics Bispecifics Other ($5/< '(9(/230(17 REGN3767 (LAG - 3) Solid/hematologic cancers REGN5458* (BCMAxCD3) Multiple myeloma REGN5678 (PSMAxCD28) Prostate cancer REGN5093 ( METxMET ) MET - altered NSCLC 5(*1 1;*,752; 6ROLGWXPRUV REGN5459* (BCMAxCD3) Multiple myeloma REGN5668 (MUC16xCD28) Ovarian cancer PiG (Peptide in HLA Groove) † Solid tumors REGN4018* (MUC16xCD3) Ovarian cancer REGN7075 (EGFRxCD28) Solid tumors ISA101b + LIBTAYO (ISA) HNSCC 9R\DJHU 6; 9 4;/,%7$<21; 9\ULDG 2; 6ROLGWXPRUV 327(17,$//< 3,927$/ 2GURQH[WDPDEA1;&' 9; [&' 2; %FHOO1+/ RP1 + LIBTAYO ( Replimune ) CSCC LIBTAYO* NSCLC LIBTAYO* BCC LIBTAYO* Cervical LIBTAYO* Adjuvant CSCC APPROVED LIBTAYO* Advanced CSCC * In collaboration with Sanofi ^ Currently on partial clinical hold † Preclinical POWERFUL AND DIVERSE ONCOLOGY PORTFOLIO FOR RATIONAL COMBINATIONS This slide contains investigational products not yet approved by regulatory authorities Additional bispecifics and combinations expected to enter the clinic in coming months 33
74; 34 BROAD COMBINATIONS PIPELINE CONTINUES TO ADVANCE AND GROW * In collaboration with Sanofi ^ Currently on partial clinical hold This slide contains investigational products not yet approved by regulatory authorities COMBINATIONS INDICATIONS STATUS ONGOING Odronextamab^ (CD20xCD3) + LIBTAYO* Lymphoma Resubmit modified study design to FDA ^ REGN4018* (MUC16xCD3) + LIBTAYO* Ovarian cancer Dose escalation ongoing REGN5678 (PSMAxCD28) + LIBTAYO* Prostate cancer Dose escalation ongoing REGN3767 (LAG - 3) + LIBTAYO* Advanced cancers Expansion cohort enrolling REGN5668 (MUC16xCD28) + REGN4018* / LIBTAYO* Ovarian cancer IND open REGN6569 (GITR) + LIBTAYO* Solid tumors Enrolling REGN7075 (EGFRxCD28) + LIBTAYO* Solid tumors IND open UPCOMING odronextamab (CD20xCD3) + B cell/CD28 costim B - NHL IND filed REGN5458/9* (BCMAxCD3) + Plasma cell/CD28 costim Multiple myeloma IND filing in 2021 TAAxCD3 + LIBTAYO* Prostate cancer IND filing in 2021 odronextamab (CD20xCD3) + Standard of Care B - NHL Initiating in 2021 REGN5458/9* (BCMAxCD3) + Standard of Care Multiple myeloma Initiating in 2021 VelocImmune 74; Antibodies CD3 BiSpecifics Costim BiSpecifics Anti - PD - 1
EMPOWERING OUR COLLABORATIONS TO ADVANCE THE NEXT GENERATION OF GENETICS - BASED MEDICINES 35 All trademarks are the property of their respective owners. RGC – Regeneron Genetics Center; EHR – Electronic Health Records; CAR – Chimeric Antigen Receptor; PiG – Peptide in Groove RNAi THERAPEUTICS CAR - T & OTHER CELL BASED THERAPIES World leading human sequencing • >1M human exomes sequenced • linked to EHRs • BIG DATA CRISPR/Cas9 VIRAL - BASED GENE THERAPY • RGC helps discover gene targets for hearing loss • Developing novel ways to engineer viral - based gene therapy to the ear • RGC helps discover new gene targets • First - in - class antibody/ RNAi combinations (e.g. C5) • First - ever CRISPR - based systemic gene therapy (TTR) • RGC helps discover new gene targets • Inventing new technologies for “CRISPR - based gene knock - in” • Technologies to discover new CAR - T targets • Creating new CARs • Novel tumor targeting moieties ( e.g.PiG Abs)
KEY UPCOMING MILESTONES (12 - 18 MONTHS) 36 EYLEA: Ph2 data readout for High Dose formulation Dupixent • Regulatory submissions 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 anticipated in 1L NSCLC chemo combo and 2L Cervical Odronextamab (CD20xCD3) • Complete enrollment in potentially pivotal Phase 2 in NHL • Initiate OLYMPIA Phase 3 program and evaluate combinations REGN5458 (BCMAxCD3) • Complete enrollment in potentially pivotal Phase 2 in Multiple Myeloma • Evaluate combinations with standard of care and novel agents New Bispecifics: Potential first data for MUC16xCD3 and PSMAxCD28 Evinacumab (ANGPTL3): Regulatory action for HoFH (PDUFA date 2/11/21) This slide contains investigational products not yet approved by regulatory authorities NSCLC – Non - Small Cell Lung Cancer BCC – Basal Cell Carcinoma NHL – Non - Hodgkin’s Lymphoma HoFH – Homozygous Familial hypercholesterolemia EoE – Eosinophilic Esophagitis
74; 37 Q&A 39; 9; 5HJHQHURQ3KDUPDFHXWLFDOV,QF7;$OO5LJKWV5HVHUYHG7; George D. Yancopoulos, MD, PhD President & Chief Scientific Officer Marion McCourt EVP, Head of Commercial Robert Landry EVP, Chief Financial Officer Leonard S. Schleifer MD, PhD President & Chief Executive Officer
RECONCILIATION OF GAAP NET INCOME TO NON - GAAP NET INCOME 38 REGENERON PHARMACEUTICALS, INC. RECONCILIATION OF GAAP NET INCOME TO NON - GAAP NET INCOME (Unaudited) (In millions, except per share data) 3;6HHVOLGH IRUDGGLWLRQDOLPSRUWDQWLQIRUPDWLRQUHJDUGLQJQRQ 6; *$$3ILQDQFLDOPHDVXUHVLQFOXGHGLQWKLVSUHVHQWDWLRQ