Full Press Release Details
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; 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
THESE TECHNOLOGIES ENABLED RAPID DEVELOPMENT AND ADVANCEMENT OF OUR COVID - 19 ANTIBODY COCKTAIL 8VLQJ 9HORFL6XLWH 38; WHFKQRORJLHV 5; GLVFRYHU\DQGSUHFOLQLFDOYDOLGDWLRQZHUH FRPSUHVVHGWR 0217+6 YV7;\HDUV 7; 9LURORJ\UHVXOWV 1RQ 6; KRVSLWDOL]HGVWXG\ 6WDWLVWLFDOO\VLJQLILFDQW DQWL 6; YLUDODFWLYLW\DJDLQVW6$56 6; &29 6; LQ VHURQHJDWLYHSDWLHQWV This project has been funded in whole or in part with Federal funds from BARDA under OT number: HHSO100201700020C &DVLULYLPDE DQG LPGHYLPDE LVDQLQYHVWLJDWLRQDOPHGLFLQH7;7KHVDIHW\DQGHIILFDF\RIWKLVGUXJFDQGLGDWHDUH VWLOOEHLQJHYDOXDWHGE\UHJXODWRU\DXWKRULWLHV /6PHDQYLUDOORDG1;4;8; 6; 6(2; LQORJ 9; FRSLHV8;P/ 'D\ 0HDQ&KDQJHIURP %DVHOLQHLQ6$56 6; &29 6; 9LUDO/RDG2YHU7LPH &OLQLFDOUHVXOWV 1RQ 6; KRVSLWDOL]HGVWXG\ UHGXFWLRQLQ&29,' UHODWHG PHGLFDOYLVLWV1;79;09V80;5;H7;J7;(58;XUJHQWFDUHYLVLWV5;KRVSLWDOL]DWLRQV2; 35; UHGXFWLRQLQ09VLQRYHUDOOSRSXODWLRQ1;Q 2; 35; UHGXFWLRQLQ09VLQWDUJHWHGSRSXODWLRQ1;RQHRU PRUHULVNIDFWRUV5;VHURQHJDWLYHDQGKLJKYLUDOORDG2; %DVLVIRUWKHJUDQWHG(8$ +RVSLWDOL]HGVWXG\ SDVVHGLQLWLDOIXWLOLW\DQDO\VLV 35; UHGXFWLRQLQULVNRIGHDWKRUPHFKDQLFDOYHQWLODWLRQ LQVHURQHJDWLYHSDWLHQWVRQORZ 6; IORZR[\JHQ 1;Q +5 9;7; 9; &, 9;7; 6; 7; 2;
9; COVID - 19 ANTIBODY COCKTAIL: BROAD CLINICAL DEVELOPMENT PROGRAM $SSURDFKLQJ 5;9;9;9; SDWLHQWVHQUROOHGWRGDWH 3URJUDP6WDWXV8SGDWH &DVLULYLPDE DQG LPGHYLPDE LVDQLQYHVWLJDWLRQDOPHGLFLQH7;7KHVDIHW\DQG HIILFDF\RIWKLVGUXJFDQGLGDWHDUHVWLOOEHLQJHYDOXDWHGE\UHJXODWRU\DXWKRULWLHV7; EUA granted for mild to moderate COVID - 19 in high - risk patients Additional data (including lower 1.2g dose) in late 1Q21 678'< 9; 1RQ 6; +RVSLWDOL]HG 1;,92; 6HDPOHVV3K 8; 8; 35; 3DVVHGIXWLOLW\DQDO\VLVLQ/RZ)ORZ2 SDWLHQWV 35; 8.5(&29(5<7ULDORQJRLQJ1;LQFOXGLQJSDWLHQWVUHTXLULQJ KLJK 6; IORZR[\JHQRUPHFKDQLFDOYHQWLODWLRQ2; 678'< 9; +RVSLWDOL]HG 1;,92; 6HDPOHVV3K 8; 8; 1R2 UHTXLUHPHQW_/RZ)ORZ2 Data expected in 1H21 678'< 9; +RXVHKROG&RQWDFWV 3URSK\OD[LV 1;642;3K 35; ([SORULQJORZHUGRVHVDQGUHSHDWHGGRVLQJ 678'< 9; 'RVH5DQJLQJ 9LURORJ\6WXG\ 678'< 9; +90XOWLGRVH This project has been funded in whole or in part with Federal funds from BARDA under OT number: HHSO100201700020C
3R]HOLPDE 1;& 2; 5(1 9; 3; 1;08& [&' 2; 5((1(521 6; ',6&29(5('5;$33529('$1',19(67,$7,21$/ 0(',&,1(6$&5266$:,'($1'',9(56(6(72)',6($6(6 PHASE 1 3+$6( 5$5(',6($6(6 5(1 1;/(352; Cemiplimab (PD - 1) 5(1 1;/$ 6; 2; 5(1 9; 6; 9; 1;)HOG 2; &HPLSOLPDE3; 1;3' 6; 2; Itepekimab (IL - 33) 'XSLOXPDE 3; 1;,/ 6; 52; 6DULOXPDE3; 1; ,/ 6; 52; $OLURFXPDE 1;3&6. 2; Cemiplimab (PD - 1) 'XSLOXPDE3; 1;,/ 6; 52; )DVLQXPDE 30; 1;1*)2; 3+$6( Evinacumab (ANGPTL3) DUHWRVPDE 1;$FWLYLQ 6; $2; &$5',29$6&8/$58; 0(7$%2/,&',6($6(6 21&2/2< INFECTIOUS DISEASES 23+7+$/02/2*< 3$,1 ,00812/2*< ,1)/$00$725<',6($6(6 21 5(*1 6; 6; 1;%HWY 2; 5(1 1;360$[&' 2; $IOLEHUFHSW 1;9()7UDS2; Odronextamab (CD20xCD3) 5(*1 3; 1;%&0$[&' 2; 5(1 9; 1; 0(7[0(7 2; $IOLEHUFHSW 1;9()7UDS2; As of 3Q20 10 - Q filing This slide contains investigational products not yet approved by regulatory authorities 3;,QFROODERUDWLRQZLWK6DQRIL 30;,QFROODERUDWLRQZLWK7HYDDQG0LWVXELVKL7DQDEH A,QFROODERUDWLRQZLWK5RFKH &DVLULYLPDEDQG,PGHYLPDE A 1;6$56 6; &R9 6; 2; 5(*1 1;,/ 6; 5J2; REGN5458 * (BCMAxCD3) 5(1 1;,752; 5(*1 1;135 2; 2GURQH[WDPDE 1;&' 9; [&' 2; Casirivimab and Imdevimab ^ (SARS - CoV - 2) &DVLULYLPDEDQG,PGHYLPDE A 1;6$56 6; &R9 6; 2; &DVLULYLPDE 8; ,PGHYLPDE
PROGRESSING AND EXPANDING DUPIXENT'S CLINICAL DEVELOPMENT PROGRAM FOR MANY TYPE 2 DISEASES 7KLVVOLGHFRQWDLQVLQYHVWLJDWLRQDOLQGLFDWLRQVQRW\HWDSSURYHGE\UHJXODWRU\DXWKRULWLHV 7\SH &23' 9;9; N 74k 3UXULJR 1RGXODULV %XOORXV 3HPSKLJRLG N Eosinophilic Esophagitis N $OOHUJLF)XQJDO 5KLQRVLQXVLWLV N Chronic Inducible Urticaria - Cold N $SSURYHGLQGLFDWLRQVDGGUHVV 4;PLOOLRQ HOLJLEOHSDWLHQWVLQ WKH87;67;ZLWK 7\SH GLVHDVHV &6V13 130k &KURQLF 6SRQWDQHRXV 8UWLFDULD 9; N 'XSL[HQWFOLQLFDOWULDOVSURYHWKDW,/ 6; DQG,/ 6; DUHNH\ GULYHUVRIPXOWLSOH7\SH LQIODPPDWRU\FRQGLWLRQV Dupixent is currently in pivotal trials for EIGHT Type 2 diseases; potential to address disease in ~1 million additional patients $WRSLF 'HUPDWLWLV 7; 0 $VWKPD 975k &56Z13 9; N )LJXUHVUHSUHVHQW87;67;%LRORJLF 6; HOLJLEOHWDUJHWSRSXODWLRQ1;DOODJHJURXSV2; CRSwNP - Chronic Rhinosinusitis with Nasal Polyposis; COPD - Chronic Obstructive Pulmonary Disease; CSsNP - Chronic Sinusitis without Nasal Polyposis $SSURYHG,QGLFDWLRQV 3RWHQWLDOLQGLFDWLRQVZLWK32& 2WKHULQYHVWLJDWLRQDOXVHV
Type 2 COPD '83,;(17 ,7(3(.,0$% 1;$17,,/ 6; 2; 77; 7:2 6; 3521*('$3352$&+$*$,167 &+521,&2%6758&7,9(38/021$5<',6($6(1;&23'2; 7KLVVOLGHFRQWDLQVLQYHVWLJDWLRQDOLQGLFDWLRQVQRW\HWDSSURYHGE\UHJXODWRU\DXWKRULWLHV Dupixent clinical trials prove that IL - 4 and IL - 13 are key drivers of multiple Type 2 inflammatory conditions ,QWHUNHXNLQ 6; 1;,/ 6; 2;LVDNH\GULYHURIOXQJLQIODPPDWLRQ 3K SURRI 6; RI 6; FRQFHSWGDWD LQGLFDWHVSRWHQWLDOEHQHILW LQIRUPHUVPRNHUV $FKLHYHGSUHVSHFLILHG HIILFDF\PLOHVWRQHLQLQWHULP DQDO\VLVRIILUVW3K VWXG\ Dupixent addresses Type 2 COPD ,WHSHNLPDE DGGUHVVHVDOVR QRQ 6; 7\SH &23' 3;'XSL[HQWDQG ,WHSHNLPDE DUHGHYHORSHGLQFROODERUDWLRQZLWK6DQRIL
,WHSHNLPDE DGGUHVVHVDOVR QRQ 6; 7\SH &23' 1RHRVLQRSKLOUHVWULFWLRQ )RFXVRQIRUPHUVPRNHUV 3K WULDOVLQLWLDWHG 3LYRWDOGDWDH[SHFWHG 9; ADDRESSING UNMET NEED IN COPD ; PHASE 3 PROGRAMS UNDERWAY 3;'XSL[HQWDQG ,WHSHNLPDE DUHGHYHORSHGLQFROODERUDWLRQZLWK6DQRIL A86HSLGHPLRORJ\HVWLPDWHV5;SDWLHQWSRSXODWLRQVH[FOXGHQHYHUVPRNHUV 7KLVVOLGHFRQWDLQVLQYHVWLJDWLRQDOLQGLFDWLRQVQRW\HW DSSURYHGE\UHJXODWRU\DXWKRULWLHV Itepekimab only ~350K patients 'XSL[HQW DGGUHVVHV 7\SH &23' (RVLQRSKLOV49; 9;9; 8; O %RWKIRUPHUDQGFXUUHQWVPRNHUV 3K WULDOVRQJRLQJ 3LYRWDOGDWDH[SHFWHG 9; 'XSL[HQWRU ,WHSHNLPDE ! 9;9; .SDWLHQWV Dupixent only ~100K patients 1RQ 6; 7\SH 7\SH )RUPHU6PRNHUV 1; 9; RI&23'SDWLHQWVA2; Current Smokers (30% of COPD patients^)
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 3LV 5; 9HORFL1DWRU 70 5; RWKHUV Our bispecific antibodies are investigational and have not been fully evaluated by regulatory authorities.
38; 5((1(52182;69(/2&, 6; %, 38; $3352$&+&$1&5($7(5;0$18)$&785(5;$1' '(9(/23+,+ 6; 48$/,7<%,63(&,),&62)$1<'(6,5('63(&,),&,7< Costim - CD28 - engaging, costimulatory molecule 9(/2&, 6; %, 38; VelociGene 74; and VelocImmune 74; technologies are fundamental Foundation for Dupixent, Praluent, Libtayo, REGN - EB3 ( Inmazeb ), COVID - 19 Ab cocktail and other Regeneron - discovered medicines Next - generation VelocImmune 74; used to create 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 7FHOODFWLYDWRUV 7FHOO FRVWLPV $QWL 6; &' Anti - CD28 &' 9; %&0$ 2WKHUV 08& (*)5 360$ 7$$+HPH .LOOHU7 &HOO .LOOHU7 &HOO "Signal 1" 79;6LJQDO 80; 7XPRU &HOO 7$$ 5; 7$$
38; 28 5((1(52182;6&' &' &2 67,08/$725< %,63(&,),&6$5(2)) 6; 7+( 6; 6+(/)'586 :,7+327(17,$/7278513$7,(17682;7&(//6,17278025&(//.,//(56 2XUELVSHFLILFDQWLERGLHVDUHLQYHVWLJDWLRQDODQGKDYHQRWEHHQIXOO\HYDOXDWHGE\UHJXODWRU\DXWKRULWLHV7; 6LJQDO Signal 1 4; &' &RVWLPXODWRU\ ELVSHFLILF &' ELVSHFLILF Costim &' &' &' CD3 7&5 7&5 &' CD3 3' 6; 3' 6; / 8; 7XPRU 7DUJHW Tumor Target 2 7FHOODFWLYDWLRQFDQEHLQKLELWHG E\3' 6; VLJQDOLQJ 8VLQJ /,%7$<2 WREORFN3' 6; VLJQDOLQJPD\ IXUWKHUHQKDQFHWKHHIILFDF\RI&' DQG FRVWLPXODWRU\ELVSHFLILFV /,%7$<2 T Cell 7XPRU&HOO 6LJQDO 6LJQDO Checkpoint release 79;5HOHDVH(PHUJHQF\ %UDNH80;1;DQWL 6; 3' 2; 79;7KH,JQLWLRQ80;1;6LJQDO 2; 79;7KH*DV3HGDO80;1;6LJQDO 2;
74; 2'521(;7$0$%1;&' 9; ;&' 2;'((3$1''85$%/(5(63216(6 58;5 77; 5HODSVHG8;5HIUDFWRU\1;KHDYLO\SUH 6; WUHDWHG2;'/%&/ 77; 'LIIXVH/DUJH%&HOO/\PSKRPD 255 77; 2EMHFWLYH5HVSRQVH5DWH&5 77; &RPSOHWH5HVSRQVH&56 77; &\WRNLQH5HOHDVH 6\QGURPH7($( 77; 7UHDWPHQW 6; (PHUJHQW$GYHUVH(YHQW * Patients are hospitalized for observation during step - up dosing and the first QW dose. This slide contains investigational products not yet approved by regulatory authorities $QWL 6; &' $QWL 6; &' 9; 5(1 American Society of Hematology (ASH) Dec 2020 update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a 7; \HDUVLQ)/2; 35; $FFHSWDEOHVDIHW\SURILOH 7KH3K DQG3K 2GURQH[WDPDE FOLQLFDOWULDOV DUHFXUUHQWO\RQSDUWLDOFOLQLFDOKROG7;7KH FRPSDQ\KDVVXEPLWWHGDUHVSRQVHWRWKH)'$ ZLWKWKHJRDORIUHVXPLQJSDWLHQWHQUROOPHQW HDUO\LQWKHILUVWTXDUWHURI 9; 7; R/R Follicular Lymphoma 35; 255 9; 5;&5 9; 35; 1 9; 5;GRVHV 6; 9; PJ 35; &5VRQJRLQJIRUXSWR a 7; \HDUV 58;5'/%&/1;&$5 6; 7QDwYH2; 35; 255 5;&5 35; 1 5;GRVHV 9; 6; 9; PJ 35; &5VRQJRLQJIRUXSWR PRQWKV ORR=33%, CR=21% N=24, doses 80 - 320 mg All CRs ongoing for up to 20 months 58;5'/%&/1;SRVW 6; &$5 6; 72; 'XUDEOH&5VP'R&5QRWUHDFKHGIRUDQ\LQGLFDWLRQ
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nti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fficacy: 3 - 12mg (n=24): ORR=29%, VGPR or better= 25% 24 - 48mg (n=17): ORR=41%, VGPR or better= 41% 96mg (n=8): ORR=63%, VGPR or better= 63%
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