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 10, 2022 (
(Exact name of registrant as specified in its charter)
(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification No.)
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| (Address of principal executive offices) | (Zip Code) | |
Registrant’s telephone number,
including area code: (
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):
Securities registered pursuant to Section 12(b) of the Act:
| 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 10, 2022, at the virtual 40th 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 $5.79 billion for the full year 2021 (based on preliminary (unaudited) fourth quarter 2021 U.S. net product sales of EYLEA of approximately $1.54 billion).
The presentation also includes information regarding the Company’s preliminary (unaudited) U.S. net product sales of REGEN-COV® (casirivimab and imdevimab) of approximately $5.82 billion for the full year 2021 (based on preliminary (unaudited) fourth quarter 2021 U.S. net product sales of REGEN-COV of approximately $2.29 billion).
Item 7.01. Regulation FD Disclosure.
The information set forth under Item 2.02 of this Current Report on Form 8-K is incorporated by reference herein. 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.
| 99.1 | Presentation by Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron Pharmaceuticals, Inc., and George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer of Regeneron Pharmaceuticals, Inc., at the virtual 40th Annual J.P. Morgan Healthcare Conference. | |
| 104 | Cover Page Interactive Data File - the cover page XBRL tags are embedded within the Inline XBRL document. |
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 10, 2022
Exhibit 99.1
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
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 or licensees (collectively, ”Regeneron’s Products“), and the global economy ; the nature, timing, and possible success and therapeutic applications of Regeneron’s Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “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 ), Evkeeza TM ( evinacumab ), Inmazeb ® ( atoltivimab , maftivimab , and odesivimab - ebgn ), REGEN - COV ® ( casirivimab and imdevimab ), fasinumab , garetosmab , pozelimab , odronextamab , itepekimab , REGN 5458 , REGN 5713 - 5714 - 5715 , REGN 1908 - 1909 , Regeneron’s and its collaborators’ other oncology programs (including its costimulatory bispecific portfolio), 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 Regeneron’s Product Candidates in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s 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 those listed above ; 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 or licensees 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, 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 Regeneron’s Product Candidates ; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates ; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) or recommendations and guidelines from governmental authorities and other third parties on the commercial success of Regeneron’s Products and Regeneron’s 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 ; 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, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates ; unanticipated expenses ; the costs of developing, producing, and selling products ; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance ; risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA, Dupixent, Praluent, and REGEN - COV), 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 the casirivimab and imdevimab antibody cocktail (known as REGEN - COV in the United States and Ronapreve Œ in other countries) and its REGEN - COV supply agreement with the U . S . government, 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 . 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 total revenues excluding REGEN - COV, 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 . 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 non - GAAP financial measure used in this presentation is provided on slide 28 . Note regarding forward - looking statements & non - GAAP financial measures
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/ μl 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
Regulatory Status x EUA granted for ambulatory treatment and in certain post - exposure prophylaxis settings □ EUA under review for pre - exposure prophylaxis and hospitalization x Approved in the EU for treatment and prevention □ Regulatory decision on BLA submission for treatment and prophylaxis (PDUFA 4/13/22) □ FDA no longer plans to convene an advisory committee to discuss our BLA Rapid Mobilization to Address COVID - 19 10 EUA: Emergency Use Authorization BLA: Biologics License Application 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. *Roche supplied a portion of these doses to Regeneron to fulfill Regeneron's agreement with the U.S. government. Roche is primarily responsible for development and distribution outside the U.S. Regeneron is uniquely positioned to continue to address COVID - 19 and other emerging Infectious Disease threats in the future 4Q21: Delivered ~1.1M Doses* U.S. Net Product Sales $2.29B** 2021: Delivered ~2.8M Doses* U.S. Net Product Sales $5.82B** **Based on preliminary unaudited fiscal 2021 results
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 $3B share repurchase authorization in November 2021
12 George D. Yancopoulos , MD, PhD Co - Founder, President & Chief Scientific Officer JP Morgan 2022 Upcoming Business Drivers
Regeneron Technologies Power Our Pipeline: TRAPs, Antibodies and Bispecifics 13 xx 9(/2&,*(1( Š 9(/2&,0286( Š 9(/2&,0081( Š 9(/2&,0$% Š VelociT TM 9(/2&,+80 Š 9(/2&, %L Š 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,&$/ '(9(/230(17 0(',&,1(6 TURNKEY THERAPEUTICS: TRAPs & ANTIBODIES (BISPECIFICS & COSTIMS) 5HJHQHURQ WHFKQRORJLHV KDYH GHOLYHUHG UHSHDWHG EUHDNWKURXJKV E\ DGGUHVVLQJ OLPLWDWLRQV DQG ERWWOHQHFNV LQ HYHU\ VWHS RI WKH GUXJ GLVFRYHU\
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¾ (QFRXUDJLQJ HDUO\ VLJQDOV REVHUYHG LQ D KHWHURJHQHRXV RYDULDQ FDQFHU SRSXODWLRQ ¾ 'DWD IURP GRVH HVFDODWLRQ PRQRWKHUDS\ ),+ VWXG\ DQWLFLSDWHG LQ + ¾ 'RVH HVFDODWLRQ ZLWK /,%7$<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) $QWL 3' &' %L6SHFLILFV Costim BiSpecifics New BiSpecifics ¾ 'RVH HVFDODWLRQ LQ FRPELQDWLRQ ZLWK /,%7$<2 RQJRLQJ 5(*1 08& [&' 5(*1 0 0(7[0(7 $'& » Trial Enrolling ¾ (YDOXDWLQJ FRPELQDWLRQV ZLWK /,%7$<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 ¾ 'RVH HVFDODWLRQ ZLWK /,%7$<2 RQJRLQJ ¾ ,QLWLDO GDWD H[SHFWHG LQ 7KLV VOLGH FRQWDLQV LQYHVWLJDWLRQDO SURGXFWV QRW \HW DSSURYHG E\ UHJXODWRU\ DXWKRULWLHV
21*2,1* 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 22 Novel Genetics - based Drug Target Discovery Genetics - based Drug Development & Precision Medicine Leveraging New Turnkey Therapeutic Approaches • RGC discovered >10 novel drug targets • RGC database links drug targets with disease impact, enhancing probability of clinical trial success • RGC database identifies patients most likely to benefit • siRNA gene silencing • Genome editing – Knockout/ Insertion • Targeted viral - based gene delivery and expression World leading human sequencing • >2M human exomes sequenced • Linked to Electronic Health Records • 100+ collaborations globally Powerful resource linking human genetic variation to disease; empowering strategic partnerships to drive the future of medici ne
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
Key Upcoming Milestones (Next 12 months) 26 EYLEA • Ph3 data readout for Aflibercept 8mg formulation Dupixent • Complete regulatory submission for EoE • Additional Phase 3 data readouts for CSU and PN • Regulatory decision for AD in children (6 mo – 5 yrs ) REGEN - COV • FDA decision on BLA for treatment and prophylaxis indications (PDUFA 4/13/22) • BLA submission for hospitalized patients Libtayo • Regulatory decisions for 1L NSCLC chemotherapy combination NSCLC – Non - Small Cell Lung Cancer NHL – Non - Hodgkin Lymphoma EUA – Emergency Use Authorization Solid Tumor Bispecifics • Initial data for MUC16xCD3, PSMAxCD28 and METxMET Odronextamab (CD20xCD3) • Complete enrollment in potentially pivotal Phase 2 in NHL • Initiate dosing with subcutaneous formulation • Initiate OLYMPIA Ph3 program and additional combinations REGN5458 (BCMAxCD3) • Complete enrollment in potentially pivotal Phase 2 in multiple myeloma • Ph2 data expected in multiple myeloma • Initiate studies with subcutaneous formulation • Initiate Phase 1 and Phase 3 studies exploring combinations with standard of care • Initiate additional combination studies This slide contains investigational products not yet approved by regulatory authorities AD – Atopic Dermatitis CSU – Chronic Spontaneous Urticaria PN – Prurigo Nodularis EoE – Eosinophilic Esophagitis
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