Regeneron Pharmaceuticals, Inc. · NASDAQ:REGN
Regeneron Pharmaceuticals — JP Morgan Healthcare Conference 2021
38 slides from Regeneron Pharmaceuticals's conference presentation, Jan 11, 2021
Slide 1: JP Morgan 2021, January 11th
LEONARD S. SCHLEIFER MD, P h D PRESIDENT & CEO GEORGE D. YANCOPOULOS MD, P h D PRESIDENT & CSO JP MORGAN 2021 JANUARY 11 TH
Slide 2: Forward-looking statements
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 statemen
Slide 3: Leonard S. Schleifer, President & CEO
74; Leonard S. Schleifer MD, PhD President & Chief Executive Officer 3
Slide 4: Broad and diverse pipeline, growing core brands, new launches
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 C
Slide 5: Strong execution in 2020
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
Slide 6: EYLEA, Dupixent and Libtayo core to diversified growth strategy
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
Slide 7: EYLEA: extending market leadership position
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
Slide 8: Dupixent: strong growth trajectory
$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
Slide 9: Dupixent: driving leverage in collaboration profitability
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 2Q1
Slide 10: Substantial patient opportunity in Type 2 inflammatory diseases for Dupixent
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 11: Roadmap to leadership in oncology
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 Accept
Slide 12: Significant opportunity to enhance and extend treatment benefits
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
Slide 13: COVID antibody cocktail: first combination therapy to receive EUA
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 eff
Slide 14: Evinacumab: rare disease opportunity
$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 Fa
Slide 15: Multiple potential regulatory submissions 2021-2023+
* 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 -
Slide 16: Business summary
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 aga
Slide 17: George D. Yancopoulos, President & CSO
74; George D. Yancopoulos, MD, PhD President & Chief Scientific Officer 17
Slide 18: Regeneron technologies deliver repeated breakthroughs
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 20
Slide 19: Technologies enabled rapid development of COVID-19 antibody cocktail
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\DJDLQVW
Slide 20: COVID antibody cocktail: broad clinical development program
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
Slide 21: Regeneron-discovered approved and investigational medicines
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
Slide 22: Progressing and expanding Dupixent's clinical development program
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 I
Slide 23: Dupixent and itepekimab in COPD
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 infla
Slide 24: Addressing unmet need in COPD; Phase 3 programs underway
,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[FOXG
Slide 25: Enhance oncology strategy: aspire to compete, enhance, extend
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
Slide 26: Regeneron oncology toolkit leverages multiple platforms
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;
Slide 27: Regeneron's VelociBi approach
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, Libtay
Slide 28: CD28 costimulatory bispecifics are off-the-shelf drugs
38; 28 5(*(1(52182;6&' &' &2 67,08/$725< %,63(&,),&6$5(2)) 6; 7+( 6; 6+(/)'58*6 :,7+327(17,$/7278513$7,(17682;7&(//6,17278025&(//.,//(56 2XUELVSHFLILFDQWLERGLHVDUHLQYHVWLJDWLRQDODQGKDYHQRWEHHQIXOO\HYDOXDWHGE\UHJXODWRU\DXWKRULWLHV7; 6LJQDO Signal 1 4; &' &RVWLPXODWRU\ ELVSHFLILF &' ELVSHFLILF Costim
Slide 29: Odronextamab: deep and durable responses
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 f
Slide 30: REGN5458 (BCMAxCD3) tumor activity in multiple myeloma
38; 30 5(*1 1;%&0$ [ &' 2;&203(7,7,9($17, 6; 78025$&7,9,7< 327(17,$//< 5(*,675$7,21$/3+ 81'(5:$<,108/7,3/(0<(/20$ 3;0HGLDQRI OLQHVRISULRUV\VWHPLFWKHUDS\5;LQFOXGLQJDQWL 6; &' SDWLHQWVZLWKSULPDULO\ PHGXOODU\DQGVHFUHWRU\GLVHDVH 58;5 77; 5HODSVHG8;5HIUDFWRU\1;KHDYLO\SUH 6; WUHDWHG2;255 77; 2EMHFWLYH5HVS
Slide 31: Costims combined with CD3 bispecifics show enhancement in preclinical models
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;UHFRJQ
Slide 32: Costim combinations enhance and extend benefits of checkpoint inhibitors
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; (YDOXDWLQJFRPELQDW
Slide 33: Powerful and diverse oncology portfolio
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;*,
Slide 34: Broad combinations pipeline continues to advance and grow
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* Lym
Slide 35: Empowering collaborations to advance genetics-based medicines
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 -
Slide 36: Key upcoming milestones (12 months)
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) • Da
Slide 37: Q&A
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
Slide 38: Reconciliation of GAAP net income to non-GAAP net income
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; *$$3ILQDQFLDOPHDVXUHVLQFOXGHGLQWKLVSUH
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