UNITED STATES
`SECURITIES AND EXCHANGE COMMISSION
`Washington, D.C. 20549
`FORM 10-K
`
`(Mark One)
`☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the fiscal year ended December 31, 2020
`OR
`☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
`For the transition period from __________ to __________
`
`Commission File Number: 0-19034
`
`REGENERON PHARMACEUTICALS, INC.
`
`(Exact name of registrant as specified in its charter)
`New York
`(State or other jurisdiction of incorporation or organization)
`
`13-3444607
`(I.R.S. Employer Identification No.)
`
`777 Old Saw Mill River Road Tarrytown, New York 10591-6707
`(Address of principal executive offices, including zip code)
`(914) 847-7000
`(Registrant's telephone number, including area code)
`Securities registered pursuant to Section 12(b) of the Act:
`
`Title of each class
`Common Stock - par value $.001 per share
`
`Trading Symbol
`REGN
`
`Name of each exchange on which registered
`NASDAQ Global Select Market
`
`Securities registered pursuant to section 12(g) of the Act: None
`Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act.
`
`Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act.
`
`Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
`preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90
`days.
`
`Yes ☒
`Yes ☐
`
`No ☐
`No ☒
`
`Yes ☒
`
`No ☐
`
`Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T
`(§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).
`
`No ☐
`Yes ☒
`Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the
`definitions of "large accelerated filer," "accelerated filer," "smaller reporting company," and "emerging growth company" in Rule 12b-2 of the Exchange Act.
`Large accelerated filer ☒
`Accelerated filer ☐
`Non-accelerated filer ☐
`Smaller reporting company ☐
`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.
`
`☐
`
`Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
`
`Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under
`Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report.
`
`☒
`No ☒
`Yes ☐
`The aggregate market value of the voting and non-voting common stock held by non-affiliates of the registrant was approximately $63,344,000,000, computed by reference to the closing sales
`price of the stock on NASDAQ on June 30, 2020, the last trading day of the registrant's most recently completed second fiscal quarter. For purposes of this calculation only, the registrant has
`assumed that all of its directors and executive officers, and no other persons, are its affiliates. This determination of affiliate status is not necessarily a determination for other purposes.
`
`The number of shares outstanding of each of the registrant's classes of common stock as of January 29, 2021:
`
`Class of Common Stock
`Class A Stock, $.001 par value
`Common Stock, $.001 par value
`
`Number of Shares
`1,848,970
`105,282,929
`
`DOCUMENTS INCORPORATED BY REFERENCE
`
`Specified portions of the Registrant's definitive proxy statement to be filed in connection with solicitation of proxies for its 2021 Annual Meeting of Shareholders are incorporated by reference
`into Part III of this Form 10-K. Exhibit index is located on pages 92 to 97 of this filing.
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 1
`
`

`

`REGENERON PHARMACEUTICALS, INC.
`ANNUAL REPORT ON FORM 10-K
`TABLE OF CONTENTS
`
`Page Numbers
`
`Table of Contents
`
`PART I
`Item 1.
`Item 1A.
`Item 1B.
`Item 2.
`Item 3.
`Item 4.
`
`PART II
`Item 5.
`
`Item 6.
`Item 7.
`
`Item 7A.
`Item 8.
`Item 9.
`
`Item 9A.
`Item 9B.
`
`PART III
`Item 10.
`Item 11.
`Item 12.
`
`Item 13.
`Item 14.
`
`PART IV
`Item 15.
`Item 16.
`
`SIGNATURE PAGE
`
`Business
`Risk Factors
`Unresolved Staff Comments
`Properties
`Legal Proceedings
`Mine Safety Disclosures
`
`Market for Registrant's Common Equity, Related Stockholder Matters, and Issuer
`Purchases of Equity Securities
`Selected Financial Data
`Management's Discussion and Analysis of Financial Condition and Results of
`Operations
`Quantitative and Qualitative Disclosures About Market Risk
`Financial Statements and Supplementary Data
`Changes in and Disagreements with Accountants on Accounting and Financial
`Disclosure
`Controls and Procedures
`Other Information
`
`Directors, Executive Officers and Corporate Governance
`Executive Compensation
`Security Ownership of Certain Beneficial Owners and Management and Related
`Stockholder Matters
`Certain Relationships and Related Transactions, and Director Independence
`Principal Accounting Fees and Services
`
`Exhibits and Financial Statement Schedules
`Form 10-K Summary
`
`2
`37
`71
`71
`72
`72
`
`72
`
`74
`75
`
`89
`90
`90
`
`90
`91
`
`91
`91
`91
`
`91
`91
`
`91
`98
`
`99
`
`"ARCALYST ," "Evkeeza ," "EYLEA ," "Inmazeb ," "Libtayo " (in the United States), "Praluent " (in the United States), "REGEN-COV ,"
`®
`™
`®
`™
`®
`®
`™
`®
`®
`®
`®
`®
`®
`®
`®
`Regeneron ," "Regeneron Genetics Center ," "Veloci-Bi ," "VelociGene ," "VelociHum ," "VelociMab ," "VelocImmune ," "VelociMouse ,"
`®
`™
`®
`"VelociSuite ," "VelociT ," and "ZALTRAP " are trademarks of Regeneron Pharmaceuticals, Inc. Trademarks and trade names of other companies
`appearing in this report are, to the knowledge of Regeneron Pharmaceuticals, Inc., the property of their respective owners.
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 2
`
`

`

`Table of Contents
`
`ITEM 1. BUSINESS
`
`PART I
`
`This Annual Report on Form 10-K contains forward-looking statements that involve risks and uncertainties relating to future events and the future
`performance of Regeneron Pharmaceuticals, Inc. (where applicable, together with its subsidiaries, "Regeneron," "Company," "we," "us," and "our"), 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 product candidates
`being developed by Regeneron and/or its collaborators (collectively, "Regeneron's Product Candidates") and research and clinical programs now
`underway or planned, including without limitation EYLEA (aflibercept) Injection, Dupixent (dupilumab) Injection, Libtayo (cemiplimab) Injection,
`®
`®
`®
`Praluent (alirocumab) Injection, Kevzara (sarilumab) Injection, Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV™
`®
`®
`TM
`(casirivimab and imdevimab), fasinumab, Evkeeza (evinacumab), garetosmab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-
`TM
`5715, Regeneron's 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; the likelihood and timing of achieving any of our anticipated development milestones
`referenced in this report; 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 our late-stage product candidates and new indications for
`Regeneron's Products, including without limitation EYLEA, Dupixent, Libtayo, Praluent, Kevzara, REGEN-COV, fasinumab, Evkeeza, garetosmab,
`pozelimab, odronextamab, itepekimab, REGN5458, and REGN5713-5714-5715; the extent to which the results from the research and development
`programs conducted by us and/or our 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 our 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 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) on the commercial success
`of Regeneron's Products and Regeneron's Product Candidates; our ability to manufacture and manage supply chains for multiple products and product
`candidates; the ability of our 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 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 (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;
`unanticipated expenses; the costs of developing, producing, and selling products; our ability to meet any of our financial projections or guidance, including
`without limitation capital expenditures, and changes to the assumptions underlying those projections or guidance; the potential for any license or
`collaboration agreement, including our 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 REGEN-COV, to be cancelled or terminated; and 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 described further in Note 15 to our Consolidated Financial Statements included in this report),
`other litigation and other proceedings and government investigations relating to the Company and/or its operations (including without limitation those
`described in Note 15 to our Consolidated Financial Statements included in this report), the ultimate outcome of any such proceedings and investigations,
`and the impact any of the foregoing may have on our business, prospects, operating results, and financial condition. These statements are made based on
`management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements. In evaluating such statements, shareholders
`and potential investors should specifically consider the various factors identified under Part I, Item 1A. "Risk Factors," which could cause actual events
`and results to differ materially from those indicated by such forward-looking statements. We do not undertake any obligation to update (publicly or
`otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.
`
`2
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 3
`
`

`

`Table of Contents
`
`General
`
`Regeneron Pharmaceuticals, Inc. is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes
`medicines for the treatment of serious diseases. Our commercialized medicines and product candidates in development are designed to help patients with
`eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, infectious diseases, and rare diseases.
`
`Our core business strategy is to maintain a strong foundation in basic scientific research and discovery-enabling technologies, and to build on that
`foundation with our clinical development, manufacturing, and commercial capabilities. Our objective is to continue to be an integrated, multi-product
`biotechnology company that provides patients and medical professionals with important options for preventing and treating human diseases.
`
`Selected financial information is summarized as follows:
`
`Year Ended December 31,
`2020
`2019
`2018
`*
`*
`(In millions, except per share data)
`8,497.1 $
`6,557.6 $
`5,145.6
`$
`Revenues
`3,513.2 $
`2,115.8 $
`2,444.4
`$
`Net income
`30.52 $
`18.46 $
`21.29
`$
`Net income per share - diluted
` Certain revisions have been made to the previously reported revenues for the years ended December
`*
`31, 2019 and 2018. See Note 1 to our Consolidated Financial Statements for further details.
`
`For purposes of this report, references to our products encompass products marketed or otherwise commercialized by us and/or our collaborators and
`references to our product candidates encompass product candidates in development by us and/or our collaborators (in the case of collaborated products or
`product candidates under the terms of the applicable collaboration agreements), unless otherwise stated or required by the context.
`
`Products
`
`Products that have received marketing approval are summarized in the table below.
`
`Product
`(1)
`EYLEA (aflibercept) Injection
`
`(2)
`Dupixent (dupilumab) Injection
`
`(2)
`Libtayo (cemiplimab) Injection
`
`Disease Area
`- Neovascular age-related macular degeneration
`("wet AMD")
`- Diabetic macular edema ("DME")
`- Macular edema following retinal vein
`occlusion ("RVO"), which includes macular
`edema following central retinal vein occlusion
`("CRVO") and macular edema following
`branch retinal vein occlusion ("BRVO")
`- Myopic choroidal neovascularization
`("mCNV")
`- Diabetic retinopathy
`- Neovascular glaucoma ("NVG")
`(5)
`- Atopic dermatitis (in adults and adolescents)
`- Atopic dermatitis (in pediatrics 6–11 years of
`age)
`Asthma (in adults and adolescents)
`- Chronic rhinosinusitis with nasal polyposis
`("CRSwNP")
`- Metastatic or locally advanced cutaneous
`squamous cell carcinoma ("CSCC")
`
`3
`
`U.S.
`a
`
`Territory
`Japan
`a
`
`EU
`a
`
`ROW
`(4)
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`a
`
`a
`a
`
`a
`
`a
`a
`
`a
`a
`
`a
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 4
`
`

`

`Table of Contents
`
`Product (continued)
`Praluent (alirocumab) Injection
`(3)
`
`Kevzara (sarilumab) Solution for
`Subcutaneous Injection
`(2)
`Inmazeb (atoltivimab, maftivimab, and
`odesivimab-ebgn) Injection
`ARCALYST (rilonacept) Injection for
`®
`Subcutaneous Use
`(8)
`
`Disease Area
`LDL-lowering in heterozygous familial
`hypercholesterolemia ("HeFH") or clinical
`atherosclerotic cardiovascular disease
`("ASCVD") (in adults)
`- Cardiovascular risk reduction in patients with
`established cardiovascular disease
`- Rheumatoid arthritis ("RA") (in adults)
`
`- Infection caused by Zaire ebolavirus
`
`- Cryopyrin-Associated Periodic Syndromes
`("CAPS"), including Familial Cold Auto
`inflammatory Syndrome ("FCAS") and
`Muckle-Wells Syndrome ("MWS")
`- Deficiency of Interleukin-1 Receptor
`Antagonist ("DIRA") (in adults and pediatrics)
`- Metastatic colorectal cancer ("mCRC")
`
`U.S.
`a
`
`Territory
`Japan
`(7)
`
`EU
`a
`
`ROW
`(4)
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`a
`
`ZALTRAP (ziv-aflibercept) Injection for
`®
`Intravenous Infusion
`(6)
`Note 1: Refer to "Net Product Sales of Regeneron-Discovered Products" section below for information regarding whether net product sales for a particular
`product are recorded by us, Bayer, or Sanofi
`Note 2: Refer to product label in each territory for specific information
`In collaboration with Bayer (outside the United States)
`(1)
` In collaboration with Sanofi
`(2)
` In collaboration with Sanofi prior to April 2020. Effective April 2020, the Company is solely responsible for the development and commercialization of
`(3)
`Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States. Pursuant to
`the April 2020 agreement, Sanofi pays us a royalty on net product sales of Praluent outside the United States. Refer to "Collaboration, License, and Other
`Agreements - Sanofi" section below for further details.
` Rest of world. Checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States,
`(4)
`European Union ("EU"), or Japan.
` Approval in Japan is for adults and adolescents 15 years of age and older
`(5)
` Pursuant to a 2015 amended and restated ZALTRAP agreement, Sanofi is solely responsible for the development and commercialization of ZALTRAP, and
`(6)
`Sanofi pays us a percentage of aggregate net product sales of ZALTRAP
` No longer marketed by Sanofi in Japan due to injunction (see Note 15 to our Consolidated Financial Statements for further details)
`(7)
` Pursuant to a 2017 license agreement with Kiniksa Pharmaceuticals, Ltd., we granted Kiniksa the right to develop and commercialize certain new indications
`(8)
`for ARCALYST. We currently maintain exclusive rights to ARCALYST in the United States for existing indications. Commencing with the receipt of marketing
`approval by Kiniksa for the first new indication of ARCALYST in the United States, we will grant U.S. commercial rights to ARCALYST for all approved
`indications and Kiniksa will pay us a share of ARCALYST profits. Refer to "Collaboration, License, and Other Agreements - Kiniksa" section below for further
`details.
`
`Additional Information - Product Updates
`
`Inmazeb
`
`Inmazeb is a cocktail of three fully human monoclonal antibodies that each bind to the Ebola virus at different points, which may serve to increase efficacy,
`reduce the development of viral sequences that lead to resistance, and potentially enable utility in future outbreaks as viruses continue to evolve. In October
`2020, the U.S. Food and Drug Administration ("FDA") approved Inmazeb for the treatment of infection caused by Zaire ebolavirus in adult and pediatric
`patients, including newborns of mothers who have tested positive for the infection. In connection with this approval, we were also granted a material threat
`medical countermeasure priority review voucher by the FDA.
`
`REGEN-COV - Emergency Use Authorization
`In November 2020, REGEN-COV (antibody cocktail casirivimab and imdevimab administered together) received Emergency Use Authorization ("EUA")
`from the FDA for the treatment of mild to moderate COVID-19 in adults, as well as in pediatric patients at least 12 years of age and weighing at least 40
`kg, who have received positive results of direct SARS-CoV-2 viral testing and are
`
`4
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 5
`
`

`

`Table of Contents
`
`at high risk for progressing to severe COVID-19 and/or hospitalization. The EUA is temporary and does not replace a formal Biologics License
`Application ("BLA") submission review and approval process. This use is authorized only for the duration of the declaration that circumstances exist
`justifying the authorization of the emergency use, unless terminated or revoked sooner. See information regarding ongoing clinical trials of REGEN-COV
`below.
`
`Net Product Sales of Regeneron-Discovered Products
`
`Net Product
`Year Ended December 31,
`Sales
`2018
`2019
`2020
`Recorded by
`Regeneron
`Total
`ROW
`U.S.
`Total
`ROW
`U.S.
`Total
`ROW
`U.S.
`(In millions)
`(a)
`$ 4,947.2 $ 2,961.5 $ 7,908.7 $ 4,644.2 $ 2,897.4 $ 7,541.6 $ 4,076.7 $ 2,668.9 $ 6,745.6
`U.S.
`EYLEA
`$ 3,226.2 $
`818.6 $ 4,044.8 $ 1,871.2 $
`444.4 $ 2,315.6 $
`776.3 $
`145.7 $
`922.0
`Dupixent
`(b)
`(b)
`$
`270.7 $
`77.5 $
`348.2 $
`175.7 $
`18.1 $
`193.8 $
`14.8
`— $
`14.8
`U.S.
`Libtayo
`(c)
`$
`186.0 $
`172.8 $
`358.8 $
`126.0 $
`162.7 $
`288.7 $
`181.3 $
`125.5 $
`306.8
`U.S.
`Praluent
`$
`141.6 $
`128.3 $
`269.9 $
`129.0 $
`77.7 $
`206.7 $
`74.7 $
`21.9 $
`96.6
`Kevzara
`(b)
`(d)
`$
`185.7
`— $
`185.7
`—
`—
`—
`—
`—
`—
`U.S.
`REGEN-COV
`$
`5.8 $
`97.9 $
`103.7 $
`7.3 $
`101.1 $
`108.4 $
`9.0 $
`98.8 $
`107.8
`ZALTRAP
`(b)
`$
`13.1
`— $
`13.1 $
`14.5
`— $
`14.5 $
`14.7
`— $
`14.7
`U.S.
`ARCALYST
`(a)
` Regeneron records net product sales of EYLEA in the United States. Bayer records net product sales of EYLEA outside the United States. The Company records its
`share of profits/losses in connection with sales of EYLEA outside the United States within Bayer collaboration revenue.
`(b)
` Regeneron records net product sales of Libtayo in the United States. Sanofi records net product sales of Libtayo outside the United States and global net product
`sales of Dupixent, Kevzara, and ZALTRAP. The Company records its share of profits/losses within Sanofi collaboration revenue in connection with (i) sales of Libtayo
`outside the United States, and (ii) global sales of Dupixent and Kevzara. Sanofi pays the Company a percentage of net sales of ZALTRAP.
`(c)
` Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States. Also effective April 1, 2020, Sanofi records net product sales of
`Praluent outside the United States and pays the Company a royalty on such sales. Previously, Sanofi recorded global net product sales of Praluent and the Company
`recorded its share of profits/losses in connection with such sales within Sanofi collaboration revenue. Refer to "Products" section above and "Collaboration, License,
`and Other Agreements - Sanofi" section below for further details.
` Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S. government. Refer to "Agreements Related to COVID-19 -
`(d)
`U.S. Government" below for further details.
`
`Programs in Clinical Development
`
`Product candidates in clinical development, which are being developed by us and/or our collaborators, are summarized in the table below. We believe that
`®
`our ability to develop product candidates is enhanced by the application of our VelociSuite technology platforms (refer to "Research and Development
`Technologies - VelociSuite" section below). We continue to invest in the development of enabling technologies to assist in our efforts to identify, develop,
`manufacture, and commercialize new product candidates.
`
`There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug
`development (including any post-approval studies), uncertainties related to the enrollment and performance of clinical trials, changes in regulatory
`requirements, changes to drug pricing and reimbursement regulations and requirements, and changes in the competitive landscape affecting a product
`candidate. The planning, execution, and results of our clinical programs are significant factors that can affect our operating and financial results.
`
`We and our collaborators conduct clinical trials in multiple countries across the world. The COVID-19 pandemic and the restrictions adopted around the
`globe to reduce the spread of the disease have impacted and will continue to impact our clinical development programs. We continue to evaluate the impact
`of the COVID-19 pandemic on an individual trial basis and oversee trial management while also working to ensure patient safety and provide sufficient
`supply of product candidates for the studies. At this time, we expect fully enrolled clinical studies to remain generally on track. However, the ongoing
`pandemic continues to impact clinical trial execution in many regions across the world for us and our collaborators. The ultimate impact (including possible
`delays in recruiting and/or obtaining data) resulting from the COVID-19 pandemic will depend, among other factors, on the extent of the pandemic in the
`areas with study sites and patient populations. It is possible that the COVID-19 pandemic may cause clinical disruptions beyond those we have described.
`In addition, there may be delays in the timing of regulatory review and other projected milestones discussed in the table below.
`
`5
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 6
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`

`

`Table of Contents
`
`Refer to Part I, Item 1A. "Risk Factors" for a description of these and other risks and uncertainties that may affect our clinical programs, including those
`related to the COVID-19 pandemic.
`
`6
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 7
`
`

`

`Table of Contents
`
`Clinical Program
`
`Phase 1
`
`Phase 2
`
`EYLEA
`(b)
`
`–High-dose
`formulation in wet
`AMD
`
`Phase 3
`Ophthalmology
`–Retinopathy of
`prematurity
`("ROP")
`(c)
`
`High dose
`formulation in wet
`AMD
`
`Regulatory
`Review
`(i)
`
`2020 and 2021
`Events to Date
`
`Select Upcoming
`Milestones
`(k)
`
`–Approved by Ministry
`of Health, Labour and
`Welfare ("MHLW") for
`NVG in Japan
`
`–Pre-filled syringe
`approved by European
`Commission ("EC")
`
`–Report results from
`Phase 2 study for high-
`dose formulation in wet
`AMD (second half
`2021)
`
`Dupixent (dupilumab)
`(a)
`Antibody to IL-4R
`alpha subunit
`
`–Peanut allergy
`
`–Grass allergy
`
`–High-dose
`formulation in
`DME
`Immunology & Inflammation
`–Asthma in
`–Atopic dermatitis
`pediatrics (6–11
`in pediatrics (6
`years of age)
`months–5 years of
`(U.S.)
`age) (Phase 2/3)
`(d)
`
`–Asthma longer
`term efficacy
`and safety
`(U.S.)
`
`–200 mg auto-
`injector (U.S.)
`
`–Asthma in
`pediatrics (6–11
`years of age)
`
`–Eosinophilic
`esophagitis ("EoE")
`in adults ,
`(c)
`(d)
`adolescents , and
`(d)
`pediatrics
`
`–Chronic
`obstructive
`pulmonary disease
`("COPD")
`
`–Bullous
`pemphigoid (Phase
`2/3)
`(c)
`
`–Chronic
`spontaneous
`urticaria
`
`–Prurigo nodularis
`
`–Allergic
`bronchopulmonary
`aspergillosis
`("ABPA")
`
`Chronic inducible
`urticaria
`
`7
`
`–Approved by FDA and
`EC for expanded atopic
`dermatitis indication in
`pediatrics (6–11 years of
`age)
`
`–Report results from
`Phase 3 study for atopic
`dermatitis in pediatric
`patients (6 months–5
`years of age) (2022)
`
`–Approved by National
`Medical Products
`Administration
`("NMPA") in China for
`adults with atopic
`dermatitis
`
`–Reported that Phase 3
`trial for asthma in
`children aged 6 to 11
`years met its primary
`and key secondary
`endpoints
`
`–Approved by MHLW
`for CRSwNP in Japan
`
`–Approved by FDA and
`MHLW for 300 mg
`auto-injector
`
`–Reported that Part A of
`the Phase 3 trial in adult
`and adolescent patients
`with EoE met both co-
`primary endpoints
`
`–FDA decision on
`supplemental BLA
`("sBLA") for asthma in
`pediatrics (6–11 years of
`age) (second half 2021)
`
`–FDA decision on sBLA
`for asthma longer term
`efficacy and safety label
`update (second half
`2021)
`
`–Submit Marketing
`Authorization
`Application ("MAA")
`for asthma in pediatrics
`(6–11 years of age) (first
`quarter 2021)
`
`–Report results from
`Part B of the Phase 3
`study in adults and
`adolescents with EoE
`(second half 2021)
`
`–Report results from
`Phase 2 monotherapy
`study in peanut allergy
`(second half 2021)
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 8
`
`

`

`Table of Contents
`
`Clinical Program
`(continued)
`Dupixent (dupilumab)
`(a)
`(continued)
`
`Phase 1
`
`Phase 2
`
`Regulatory
`Review
`(i)
`
`Phase 3
`–Chronic sinusitis
`without nasal
`polyposis
`
`–Allergic fungal
`rhinosinusitis
`
`–Polyarticular-
`course juvenile
`idiopathic arthritis
`("pcJIA")
`
`–Systemic juvenile
`idiopathic arthritis
`("sJIA")
`
`–Cat allergy
`
`Kevzara (sarilumab)
`(a)
`Antibody to IL-6R
`
`Itepekimab
`(a)
`(REGN3500)
`Antibody to IL-33
`
`REGN1908-1909
`(f)
`Multi-antibody therapy
`to Feld1
`
`REGN5713-5714-5715
`Multi-antibody therapy
`to Betv1
`REGN6490
`Antibody to IL-36R
`
`–Palmo-
`plantar
`pustulosis
`
`–COPD
`
`–Birch allergy
`
`8
`
`2020 and 2021
`Events to Date
`–Reported that Phase 2
`trial of Dupixent in
`combination with
`Aimmune Therapeutics'
`AR101, an oral
`immunotherapy, in
`pediatric patients with
`peanut allergy met its
`primary and key
`secondary endpoint
`
`–Presented results from
`Phase 2a trial in grass
`allergy
`
`–Initiated second
`confirmatory Phase 3
`trial in COPD
`–Reported that Phase 3
`studies in COVID-19
`patients did not meet
`primary and key
`secondary endpoints
`
`–Discontinued clinical
`development in
`polymyalgia rheumatica
`and giant cell arteritis
`–Discontinued further
`clinical development in
`atopic dermatitis due to
`lack of efficacy
`
`Select Upcoming
`Milestones
`(k)
`–FDA decision on sBLA
`for 200 mg auto-injector
`(mid-2021)
`
`–Report results from
`Phase 3 chronic
`spontaneous urticaria
`and prurigo nodularis
`studies (second half
`2021)
`
`–Initiate Phase 3 study
`in hand and foot atopic
`dermatitis (first half
`2021)
`
`–Report results from
`Phase 2 study in cat
`allergic asthmatics (first
`half 2021)
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 9
`
`

`

`Table of Contents
`
`Clinical Program
`(continued)
`
`Phase 1
`
`Phase 2
`
`Libtayo (cemiplimab)
`(a)(h)
`Antibody to PD-1
`
`–Basal cell
`carcinoma
`("BCC")
`(pivotal study)
`
`Regulatory
`Review
`Phase 3
`(i)
`Solid Organ Oncology
`–First-line
`–First-line non-
`NSCLC,
`small cell lung
`monotherapy
`cancer ("NSCLC"),
`(U.S. and EU)
`monotherapy
`
`–Metastatic or
`locally advanced
`CSCC
`(d)
`
`–First-line NSCLC,
`chemotherapy
`combination
`
`–Advanced
`BCC (U.S. and
`EU)
`
`–Neoadjuvant
`CSCC
`
`–Second-line
`cervical cancer
`(e)
`
`–Adjuvant CSCC
`
`REGN4018
`(a)
`Bispecific antibody
`targeting MUC16 and
`CD3
`REGN5668
`Bispecific antibody
`targeting MUC16 and
`CD28
`REGN5678
`Bispecific antibody
`targeting PSMA and
`CD28
`
`–Platinum-
`resistant
`ovarian cancer
`
`–Ovarian
`cancer
`
`–Prostate
`cancer
`
`9
`
`2020 and 2021
`Events to Date
`
`Select Upcoming
`Milestones
`(k)
`
`–Reported that Phase 3
`monotherapy trial in
`first-line NSCLC met
`primary endpoint.
`Independent Data
`Monitoring Committee
`("IDMC") recommended
`stopping the trial early
`due to highly significant
`improvement in overall
`survival
`
`–Completed patient
`enrollment in Phase 3
`first-line NSCLC
`chemotherapy
`combination study
`
`–Reported that Phase 2
`study in BCC
`demonstrated clinically-
`meaningful and durable
`responses
`
`–Presented positive data
`from pivotal NSCLC
`monotherapy and BCC
`studies at the European
`Society for Medical
`Oncology ("ESMO")
`Virtual Congress 2020
`
`–Adjuvant CSCC
`program under internal
`review
`
`–FDA decision on sBLA
`(target action date of
`February 28, 2021) and
`EC decision on
`regulatory submission
`(mid-2021) for first-line
`NSCLC, monotherapy
`
`–Interim analysis from
`Phase 3 study in first-
`line NSCLC,
`chemotherapy
`combination (second
`half 2021)
`
`–FDA decision on sBLA
`(target action date of
`March 3, 2021) and EC
`decision on regulatory
`submission (mid-2021)
`for advanced BCC
`
`–Interim analysis from
`Phase 3 study in cervical
`cancer (2021)
`
`–Report results from
`Phase 1 study in
`platinum-resistant
`ovarian cancer (2022)
`
`–Report results from
`Phase 1 study in prostate
`cancer (2022)
`
`Samsung et al. v. Regeneron IPR2023-00884
`Regeneron Pharmaceuticals, Inc. Exhibit 2233 Page 10
`
`

`

`Table of C