Full Press Release Details
JP Morgan Healthcare Conference 2022 January 2022 This non - promotional presentation is intended for the investor audience and contains investigational data as well as forward - loo king statements; actual results may vary materially
JP Morgan 2022 Current Business Drivers 3 Leonard S. Schleifer MD, PhD Co - Founder, President & Chief Executive Officer
4 Executing on Our Core Competencies Investing in Regeneron Looking Ahead to the Future Driving continued growth in core franchises Emerging portfolio of immuno - oncology antibodies Leveraging Regeneron technologies in the ongoing fight against infectious diseases driving new breakthroughs and target discovery Investing $1.8 billion to expand our R&D capabilities and manufacturing capacity Announced $3 billion share repurchase program in Nov 2021 (over $7.5 billion shares repurchased since Nov 2019) Advancing a best - in - class, diversified pipeline based on in - house innovation and strategic partnerships 30+ therapeutic candidates in various stages of clinical development Expanding partnerships with leading companies in new technologies
PN - Prurigo Nodularis ; EoE - Eosinophilic Esophagitis AD - Atopic Dermatitis; CSU - Chronic Spontaneous Urticaria; NSCLC - Non - Small Cell Lung Cancer; wAMD - Wet Age - Related Macular Degeneration Delivering Results Across the Organization 5 Positive Ph3 results in four potential new indications (CSU, PN, EoE , Pediatric AD) Received approval in asthma for children ages 6 - 11 3Q 2021 YTD Total Revenues YoY* +20% Growth excluding REGEN - COV* 2021 R&D Pipeline Advancements Positive Ph2 results for Aflibercept 8mg in wAMD Positive Ph3 results when combined with chemotherapy in 1L NSCLC Increasingly Diversified Growth Drivers * Year - over - year growth, first nine months of 2021 vs. first nine months of 2020. See reconciliation of non - GAAP measure on slide 28 Advancing CD3 & CD28 bispecifics platform Emerging Genetics Medicines portfolio, established proof of concept for CRISPR - based therapy +83% Growth including REGEN - COV* EUA expanded to include post - exposure prophylaxis, positive data in COVID - 19 hospitalized patients This slide contains investigational products not yet approved by regulatory authorities
The #1 prescribed FDA approved anti - VEGF treatment for retinal disease 4Q2021 U.S. net product sales of $1.54Bn (+15% YoY)* FY2021 U.S. net product sales of $ 5.79Bn (+17% YoY)* Continuing to drive future growth Diabetic eye disease continues to be a significant growth opportunity Ph3 readouts for Aflibercept 8mg expected 2H22 Impressive competitive durability ~75% share of U.S. branded category Breadth of indications, effective treat - and - extend dosing, with established real - world safety $0.0 $0.8 $1.4 $1.7 $2.7 $3.3 $3.7 $4.1 $4.6 $4.9 $5.8 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021* * U.S. Net Product Sales, $Billion EYLEA : 10 Years of Patient Impact Extending leadership position based on efficacy and safety that has transformed millions of lives; 40+ million doses administ ere d since launch 6 Developed using our proprietary Trap technology, development on aflibercept began in 2004 and became Regeneron's second FDA - approved treatment in November 2011 as EYLEA *Based on preliminary, unaudited results
Dupixent : Strong Performance Across All Approved Indications With Significant Opportunity For Sustained Growth 7 Asthma CRSwNP Figures represent U.S. Biologic - eligible target population; Source - Regeneron Internal Epidemiology Data Target population includes age groups that are not currently approved but in clinical development CRSwNP - Chronic Rhinosinusitis with Nasal Polyposis 2.3M There remains a substantial opportunity for more patients to benefit as markets remain under penetrated 975k 90k Atopic Dermatitis Annualizing at ~$6.6B run rate ** Single digit market penetration $851 $926 $962 $1,147 $1,257 $221 $246 $301 $352 $406 3Q20 4Q20 1Q21 2Q21 3Q21 U.S. ROW Sanofi records global net product sales of Dupixent Net Product Sales, $Million ** 3Q21 global net product sales multiplied by 4
Dupixent : Near - and Long - Term Opportunities to Drive Growth Estimated regulatory submission timeline for new indications 8 Eosinophilic Esophagitis Chronic Spontaneous Urticaria Chronic Inducible Urticaria - Cold Prurigo Nodularis 74k 48k 308k* 25k 2022e Potential indications with POC Other investigational uses 2023e Type 2 COPD Bullous Pemphigoid CRSsNP Allergic Fungal Rhinosinusitis 300k 130k 27k 11k 2024+e Up to 4M+ Eligible Patients EoE sBLA submission Upcoming Events Additional ~450k Addressable Population Additional ~450k Addressable Population Report Results from additional Ph 3 PN study Report Results from additional Ph 3 CSU study Figures represent U.S. Biologic - eligible target population; dates represent expected first FDA submission Source - Regeneron Internal Epidemiology Data *Out of these eligible patients, the highest unmet need is in omalizumab non - responders (40 - 60% currently treated patients) COPD - Chronic Obstructive Pulmonary Disease; CSsNP - Chronic Sinusitis without Nasal Polyposis
Itepekimab potential also for non - Type 2 COPD In a Ph2 study*, itepekimab demonstrated 42% exacerbation reduction vs. placebo in former smokers, regardless of Type 2 status, with no safety concerns No eosinophil restriction Focus on former smokers Two Ph3 trials ongoing Pivotal data expected 2024 Dupixent & Itepekimab (anti IL - 33) COPD Phase 3s Underway Two - pronged approach against uncontrolled, moderate - to - severe COPD 9 Itepekimab only ~600K patients Dupixent potential to address Type 2 COPD Achieved prespecified efficacy milestone in interim analysis of first Ph3 study Eosinophils 300/ l Both former and current smokers Two Ph3 trials ongoing Pivotal data expected 2023 Dupixent or Itepekimab >350K patients Dupixent only ~150K patients Non - Type 2 Type 2 Former Smokers (70% of COPD patients^) Current Smokers (30% of COPD patients^) Dupixent and Itepekimab are developed in collaboration with Sanofi; COPD - Chronic Obstructive Pulmonary Disease * Rabe et al. Lancet Respir Med. 2021 ^ US, EU and Japan epidemiology, patient populations exclude never smokers (Regeneron Internal Epidemiology Data) This slide contains investigational products not yet approved by regulatory authorities U.S., EU and Japan addressable patient number estimates
Strong Financial Position Enabling Critical Investments Capital allocation priorities reflect business priorities 11 1. Invest in our best - in - class R&D capabilities 2. Pursue and fund business development opportunities to enable and synergize our R&D capabilities and technologies 3. Return cash to shareholders through share repurchases $1.8B investment in Tarrytown R&D facilities Continued investments in manufacturing capacity Productive collaborations with Alnylam and Intellia Signed new agreement with Nykode in 4Q21 Over $7.5B in share repurchases since November 2019 Announced $3B share repurchase authorization in November 2021
12 George D. Yancopoulos , MD, PhD Co - Founder, President & Chief Scientific Officer JP Morgan 2022 Upcoming Business Drivers
Regeneron Technologies Power Our Pipeline: TRAPs, Antibodies and Bispecifics 13 xx 9(/2&,(1( 9(/2&,0286( 9(/2&,0081( 9(/2&,0$% VelociT TM 9(/2&,+80 9(/2&, %L 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) TECH DEVELOPMENT TARGET DISCOVERY & VALIDATION 0$18)$&785,1 &/,1,&$/ '(9(/230(17 0(',&,1(6 TURNKEY THERAPEUTICS: TRAPs & ANTIBODIES (BISPECIFICS & COSTIMS) 5HJHQHURQ WHFKQRORJLHV KDYH GHOLYHUHG UHSHDWHG EUHDNWKURXJKV E\ DGGUHVVLQJ OLPLWDWLRQV DQG ERWWOHQHFNV LQ HYHU\ VWHS RI WKH GUXJ GLVFRYHU\
$QWLERGLHV %LVSHFLILFV Synergistic Collaborations Supercharge Regeneron's Future Turnkey Genetics Therapeutics Platforms 14 /HDUQLQJV IURP PRXVH JHQHWLFV 8QORFNLQJ FDSDELOLWLHV RI PRXVH DQG KXPDQ JHQHWLFV WKURXJK ([LVWLQJ 7XUQNH\ 7HFKQRORJLHV %LRORJLFDOV Novel Turnkey Technologies Gene Medicines 75$3V VL51$ Gene Therapy Genome editing (insertion/ knockout)
5((1 &29 $GGUHVVLQJ 7UHDWPHQW 1HHG DV ZHOO DV WKH /RQJ 7HUP 2SSRUWXQLW\ IRU &29,' 3UHYHQWLRQ ,I 6$56 &R9 UHPDLQV HQGHPLF ZH DQWLFLSDWH DQ HQGXULQJ QHHG IRU WKH LPPXQRFRPSURPLVHG 15 'HOWD % &XUUHQW 5((1 &29 DQWLERGLHV DUH DFWLYH 2PLFURQ % 0XOWLSOH QH[W JHQHUDWLRQ PRQRFORQDO DQWLERGLHV DUH DFWLYH Regulatory discussions are ongoing to establish clinical development plan Next generation antibodies are expected to enter clinical development in the first quarter of 2022 REGEN - COV is an investigational medicine that is authorized by FDA under an EUA for certain uses. The development and manufacturing of REGEN - COV have been funded in part with federal funds from BARDA. ,Q WKH 8 6 DORQH PLOOLRQV RI LPPXQR FRPSURPLVHG SHRSOH ZLOO QRW DGHTXDWHO\ UHVSRQG WR YDFFLQDWLRQ 0RQRFORQDO DQWLERG\ WUHDWPHQWV FDQ EH GRVHG SURSK\ODFWLFDOO\ WR SUHYHQW LQIHFWLRQ DQG VHYHUH &29,' GLVHDVH 3URWHFWLQJ WKH ,PPXQRFRPSURPLVHG /RQJ 7HUP 3RWHQWLDO 2SSRUWXQLW\
Regeneron Technologies Enable Rapid Response to Infectious Diseases 1H[W JHQHUDWLRQ DQWLERGLHV HIIHFWLYHO\ QHXWUDOL]H WKH 6$56 &R9 2PLFURQ YDULDQW DV ZHOO DV RWKHU YDULDQWV RI FRQFHUQ Regeneron technologies have created a library of thousands of mAbs We have identified multiple next generation' mAbs that are effective against Omicron and Delta variants Using VelociSuite technologies, discovery and preclinical validation and clinical manufacturing has been compressed 3 - 6 MONTHS vs. years with a standard process &UHDWLRQ RI DQG SUHFOLQLFDO WHVWLQJ LQ JHQHWLFDOO\ KXPDQL]HG PLFH ,VRODWLRQ RI IXOO\ KXPDQ DQWLERGLHV &UHDWLRQ RI PDQXIDFWXULQJ UHDG\ FHOO OLQHV GD\V YV PRQWKV Manufacture of clinical - grade antibodies for human use 287%5($. -13 -12 -11 -10 -9 -8 -7 0 50 100 Log M % N e u t r a l i z a t i o n A E ' Next Gen Antibody "B" Next Gen Antibodies "A+B"
)LUVW LQ FODVV OHDGLQJ WUHDWPHQW IRU DGYDQFHG &6&& $SSURYHG LQ / DGYDQFHG %&& /$* FRPELQDWLRQ / PHODQRPD GDWD SUHVHQWHG DW $6&2 %LR17HFK )L[9D[ FRPELQDWLRQ LQ SRVW 3' PHODQRPD 3K XQGHUZD\ &RQWLQXHG 3URJUHVV 'HYHORSPHQWV $FURVV 2QFRORJ\ 3LSHOLQH Regeneron positioned to enhance and extend treatment benefit across many cancer settings Heme - onc bispecifics 6ROLG WXPRU ELVSHFLILFV Dermato - Oncology 1RQ 6PDOO &HOO /XQJ &DQFHU $SSURYHG LQ / DGYDQFHG 16&/& 6XEPLWWHG V%/$ LQ / 16&/& LQ FRPELQDWLRQ ZLWK FKHPRWKHUDS\ CSCC - Cutaneous Squamous Cell Carcinoma; BCC - Basal Cell Carcinoma; NSCLC - Non - Small Cell Lung Cancer; mCRPC - metastatic Castration - Resistant Prostate cancer; NHL - Non - Hodgkin's lymphoma This slide contains investigational products not yet approved by regulatory authorities 5(*1 08& [&' 'RVH HVFDODWLRQ ZLWK /LEWD\R LQ RYDULDQ FDQFHU RQJRLQJ 5(*1 08& [&' 'RVH HVFDODWLRQ ZLWK /LEWD\R LQ RYDULDQ FDQFHU RQJRLQJ ILUVW SDWLHQWV GRVHG LQ FRPELQDWLRQ ZLWK 08& [&' ZHOO WROHUDWHG 5(*1 360$[&' 'RVH HVFDODWLRQ ZLWK /LEWD\R LQ P&53& RQJRLQJ 5(*1 360$[&' 1RZ HQUROOLQJ 5(1 ()5[&' 'RVH HVFDODWLRQ ZLWK /LEWD\R LQ DGYDQFHG FDQFHUV RQJRLQJ 5(*1 0(7[0(7 'RVH H[SDQVLRQ LQ 0(7 DOWHUHG 16&/& RQJRLQJ 5(*1 0 0(7[0(7 $'& 1RZ HQUROOLQJ Odronextamab (CD20xCD3) - Resumed enrollment in potentially pivotal Ph2 in R/R NHL REGN5458 (BCMAxCD3) - Ph1 data updated at ASH'21; potentially pivotal Ph2 in dose expansion Both will be entering combination studies with corresponding costim (CD28) bispecifics
9HORF,PPXQH $QWLERGLHV /$* ,75 &7/$ /\PSKRPD Multiple Myeloma Ovarian Cancer 5HJHQHURQ V 2QFRORJ\ 7RRONLW 3URYLGHV 8QLTXH &RPELQDWRULDO )OH[LELOLW\ Bispecifics CD3 Bispecifics CD20 BCMA MUC16 PSMA &RVWLPXODWRU\ %LVSHFLILFV 7$$ 7$$ 08& 360$ ()5 &ROODERUDWLRQV $GLFHW %LR %LR17HFK 9\ULDG 1\NRGH ,6$ VHYHQW\ ELR EOXHELUG 2WKHUV 1HZ &ODVVHV RI %LVSHFLILFV 0(7[0(7 3L*V 9HORFL1DWRU 70 Libtayo is jointly developed with Sanofi. Several agents are studied in combination with Libtayo , in addition to the combinations highlighted by boxes. 3' /LEWD\R 7KLV VOLGH FRQWDLQV LQYHVWLJDWLRQDO SURGXFWV QRW \HW DSSURYHG E\ UHJXODWRU\ DXWKRULWLHV
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(QFRXUDJLQJ HDUO\ VLJQDOV REVHUYHG LQ D KHWHURJHQHRXV RYDULDQ FDQFHU SRSXODWLRQ 'DWD IURP GRVH HVFDODWLRQ PRQRWKHUDS\ ),+ VWXG\ DQWLFLSDWHG LQ + 'RVH HVFDODWLRQ ZLWK /,%7$<2 RQJRLQJ %LVSHFLILFV IRU 6ROLG 0DOLJQDQFLHV 3RWHQWLDO WR ([WHQG %HQHILWV RI &KHFNSRLQW ,QKLELWRUV ,QLWLDO 'DWD LQ 20 2XU IRRWSULQW LQ RQFRORJ\ FRQWLQXHV WR H[SDQG 5(*1 360$[&' REGN7075 (EGFRxCD28) Lung, Advanced Cancers 2YDULDQ &DQFHU 3URVWDWH &DQFHU 5(*1 0(7[0(7 REGN4336 (PSMAxCD3) $QWL 3' &' %L6SHFLILFV Costim BiSpecifics New BiSpecifics 'RVH HVFDODWLRQ LQ FRPELQDWLRQ ZLWK /,%7$<2 RQJRLQJ 5(*1 08& [&' 5(*1 0 0(7[0(7 $'& Trial Enrolling (YDOXDWLQJ FRPELQDWLRQV ZLWK /,%7$<2 RU ZLWK 08& [&' 5(*1 08& [&' Now enrolling Explored in monotherapy and in combination with LIBTAYO Seeing early signs of clinical activity in MET exon14 skip mutation and MET protein overexpression patient populations Data anticipated in 2H22 'RVH HVFDODWLRQ ZLWK /,%7$<2 RQJRLQJ ,QLWLDO GDWD H[SHFWHG LQ 7KLV VOLGH FRQWDLQV LQYHVWLJDWLRQDO SURGXFWV QRW \HW DSSURYHG E\ UHJXODWRU\ DXWKRULWLHV
212,1 LIBTAYO* $GYDQFHG /XQJ FDQFHU FKHPR FRPER DGMXYDQW &6&& 5(1 /$ + LIBTAYO* Advanced melanoma REGN6569 (GITR) + LIBTAYO* Solid tumors REGN4018 (MUC16xCD3) + LIBTAYO* 2+ line Ovarian cancer 5(1 08& [&' + REGN4018 / LIBTAYO 2+ line Ovarian cancer 5(1 360$[&' + LIBTAYO 3+ line Prostate cancer PSMAxCD3 + REGN5678/LIBTAYO* Prostate cancer REGN7075 (EGFRxCD28) + LIBTAYO* Solid tumors Odronextamab (CD20xCD3) 3+ line Lymphoma Odronextamab (CD20xCD3) +/ - LIBTAYO* 3+ line Lymphoma REGN5458/9 (BCMAxCD3) 3+ line Multiple myeloma REGN5093 (METxMET) Advanced MET altered Lung cancer REGN5093 - M114 (METxMET ADC) MET overexpressing advanced Cancer UPCOMING odronextamab (CD20xCD3) + B cell/CD28 costim B - NHL odronextamab (CD20xCD3) + Standard of Care B - NHL REGN5458/9 (BCMAxCD3) + Plasma cell/CD28 costim Multiple myeloma REGN5458/9 (BCMAxCD3) + Standard of Care, Additional Combos Multiple myeloma Broad Oncology Pipeline Continues to Advance * In collaboration with Sanofi 21 Anti - PD - 1 VelocImmune Antibodies CD3 BiSpecifics Costim BiSpecifics New BiSpecifics This slide contains investigational products not yet approved by regulatory authorities
REGENERON GENETICS MEDICINES 23 Building the Pipeline for the Future ALN - HSD 1 HSD17B13 siRNA Nonalcoholic Steatohepatitis NTLA - 2001 2 CRISPR/Cas9 Transthyretin Amyloidosis (ATTR) Clinical Development Pre - IND CEMDISIRAN 1 C5 siRNA Immunoglobulin A Nephropathy POZELIMAB + CEMDISIRAN 1 C5 Antibody + C5 siRNA Myasthenia Gravis Paroxysmal Nocturnal Hemoglobinuria DB - OTO 3 OTOF AAV Dual Vector Gene Therapy OTOF Related Hearing Loss FACTOR 9 GENE INSERTION 2 CRISPR/Cas9 + AAV Transgene Insertion Hemophilia B ADDITIONAL PROGRAMS 30+ Programs in Research and Candidate Selection Collaborations with: 1. Alnylam Pharmaceuticals 2. Intellia Therapeutics 3. Decibel Therapeutics This graphic displays pipeline drug candidates currently undergoing clinical testing in a variety of diseases. The safety and ef ficacy of these drug candidates have not been fully evaluated by any regulatory authorities for the indications described in this secti on. FACTOR 8 GENE INSERTION 2 CRISPR/Cas9 + AAV Transgene Insertion Hemophilia A ALN - APP 1 APP siRNA Cerebral Amyloid Angiopathy , Alzheimer's Disease PNPLA3 1 PNPLA3 siRNA Nonalcoholic Steatohepatitis Regeneron is investing in and delivering technologies well beyond antibodies Several near - term opportunities emerging from Regeneron Genetics Medicines: 3 genetics medicines programs in the clinic 3 - 5 additional potential targets to advance to IND - enabling studies in next 12 months 30+ additional programs in research and candidate selection phase 10+ novel genetic targets discovered Reported landmark TTR genome editing data in Jun'21; data update anticipated in 1Q22 C5 combo program Ph3 initiations (Myasthenia Gravis and PNH) HSD17B13 siRNA healthy volunteer safety topline data read out in Nov'21 APP siRNA Ph1 start for Alzheimer's DB - OTO gene therapy (hearing loss) Ph1/2 start in 2022 GAA GENE INSERTION 2 CRISPR/Cas9 + AAV Transgene Insertion Pompe Disease
Regeneron - Discovered, Approved and Investigational Medicines Across a Wide and Diverse Set of Diseases 24 cemiplimab * (PD1) odronextamab (CD20xCD3) cemdisiran (C5) pozelimab (C5) pozelimab + cemdisiran (C5xC5) BCMAxCD3 (REGN5458) sarilumab * (IL - 6R) dupilumab* (IL - 4R) cemiplimab* (PD1) alirocumab (PCSK9) fasinumab (NGF) casirivimab + imdevimab ^ (SARS - CoV - 2) aflibercept (VEGF) dupilumab* (IL - 4R) Itepekimab * (IL - 33) Bet v 1 (REGN5713 - 5714 - 5715) Fel d 1 (REGN1908 - 1909) odronextamab (CD20xCD3) IL - 2Rg (REGN7257) TTR # (NTLA - 2001) Factor XI (REGN9933) BCMAxCD3 (REGN5459) NPR1 (REGN5381) HSD17B13 (ALN - HSD) casirivimab + imdevimab ^ (SARS - CoV - 2) IL - 36R (REGN6490) PHASE 3 APPROVED PHASE 1 PHASE 2 fianlimab (LAG - 3) METxMET (REGN5093) METxMET ADC (REGN5093 - M114) MUC16xCD3 (REGN4018) MUC16xCD28 (REGN5668) GITR (REGN6569) PSMAxCD28 (REGN5678) EGFRxCD28 (REGN7075) evinacumab (ANGPTL3) casirivimab + imdevimab ^ (SARS - CoV - 2) LEPR (REGN4461) garetosmab (Activin A) aflibercept (VEGF) Over 30 product candidates SOLID ORGAN ONCOLOGY HEMATOLOGY GENERAL MEDICINE I&I * In collaboration with Sanofi In collaboration with Teva and Mitsubishi Tanabe ^ In collaboration with Roche In collaboration with Alnylam # In collaboration with Intellia pozelimab + cemdisiran (C5xC5) As of Q3 2021 This slide contains investigational products not yet approved by regulatory authorities
Multiple Potential FDA Submissions: 2022 - 2024+ 25 New Molecule New Indication Odronextamab (CD20xCD3) B Cell NHL (2H22) REGN5458 (BCMAxCD3) R/R Multiple Myeloma (2H22) DUPIXENT* Prurigo Nodularis (1H22) Chronic Obstructive Pulmonary Disease Itepekimab (IL - 33)* REGN1908 - 1909 (Feld1) Cat Allergy DUPIXENT* Eosinophilic Esophagitis (1H22) REGN5713 - 5714 - 5715 (Betv1) Birch Allergy DUPIXENT* Chronic Inducible Urticaria - Cold (2H22) DUPIXENT* Chronic Spontaneous Urticaria (2H22) Pozelimab cemdisiran + C5 - mediated diseases ^ Partial clinical hold pending review of additional data NPDR - Non - Proliferative Diabetic Retinopathy FOP - Fibrodysplasia Ossificans Progressive EYLEA Q16W in NPDR (1H22) * In collaboration with Sanofi + In collaboration with Alnylam DUPIXENT* Bullous Pemphigoid Fianlimab (LAG3) + LIBTAYO Advanced Melanoma DUPIXENT* Chronic Obstructive Pulmonary Disease DUPIXENT* Chronic Rhinosinusitis w/o Nasal Polyposis DUPIXENT* Allergic Fungal Rhinosinusitis REGN4461 (LEPR) Generalized Lipodystrophy Garetosmab FOP ^ Aflibercept 8mg Wet AMD/DME (2H22/1H23) 2024+ 2022 2023 This slide contains investigational products not yet approved by regulatory authorities
Q&A 27 George D. Yancopoulos, MD, PhD Co - Founder, President & Chief Scientific Officer Marion McCourt E VP, Head of Commercial Robert Landry EVP, Chief Financial Officer Leonard S. Schleifer MD, PhD Co - Founder, President & Chief Executive Officer
Reconciliation of Non - GAAP Measure 28 See slide 2 for additional important information regarding non - GAAP financial measures included in this presentation