What changed in this filing

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Item 1. Business

2023-02-06 compared with 2022-02-07 · 452 added, 438 removed, 799 unchanged (53% of the section changed)

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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) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Evkeeza ® (evinacumab), Inmazeb ® (atoltivimab, maftivimab, and odesivimab-ebgn), REGEN-COV ® (casirivimab and imdevimab), aflibercept 8 mg, fasinumab, pozelimab, odronextamab, itepekimab, REGN5458, REGN5713-5714-5715, REGN1908-1909, 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 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) Injection, Libtayo ® (cemiplimab) Injection, Praluent ® (alirocumab) Injection, Kevzara ® (sarilumab) Injection, Evkeeza ® (evinacumab), aflibercept 8 mg, pozelimab, odronextamab, itepekimab, fianlimab, garetosmab, linvoseltamab, REGN5713-5714-5715, 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;

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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 the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve ™ in other countries), 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.

the potential for any license or collaboration agreement, including our agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), 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 described further in Note 16 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 16 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.

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Regeneron Pharmaceuticals, Inc.

is a fully integrated biotechnology company that discovers, invents, develops, manufactures, and commercializes medicines for 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, hematologic conditions, infectious diseases, and rare diseases.

is a fully integrated biotechnology company that invents, develops, manufactures, and commercializes medicines for people with serious diseases.

Our products and product candidates in development are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, pain, hematologic conditions, 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.

Our objective is to continue to be an integrated, multi-product biotechnology company that provides patients and medical professionals with important medicines for preventing and treating human diseases.

Selected financial information is summarized as follows:

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Product Disease Territory

EU Japan ROW (4)

EYLEA (aflibercept) Injection (1)

EU Japan ROW (e)

EYLEA (aflibercept) Injection (a)

Neovascular age-related macular degeneration ("wet AMD") a a a a

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Myopic choroidal neovascularization ("mCNV") a a a

- Diabetic retinopathy a

Diabetic retinopathy ("DR") a

Neovascular glaucoma ("NVG") a

Dupixent (dupilumab) Injection (2)

Retinopathy of prematurity ("ROP")

Dupixent (dupilumab) Injection (b)

Atopic dermatitis (in adults and adolescents) a a a a

Atopic dermatitis (in pediatrics 6–11 years of age) a a a

Atopic dermatitis (in pediatrics 6 months–5 years of age) a a

Asthma (in adults and adolescents) a a a a

- Asthma (in pediatrics 6–11 years of age) a

Asthma (in pediatrics 6–11 years of age) a a a

Chronic rhinosinusitis with nasal polyposis ("CRSwNP") a a a a

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Disease Territory

EU Japan ROW (4)

Libtayo (cemiplimab) Injection (2)

EU Japan ROW (e)

Dupixent (dupilumab) Injection (b) (continued)

Eosinophilic esophagitis ("EoE") (in adults and adolescents)

Prurigo nodularis a a a

Libtayo (cemiplimab) Injection (c)

Metastatic or locally advanced first-line non-small cell lung cancer ("NSCLC")

Metastatic or locally advanced first-line NSCLC (in combination with chemotherapy)

Metastatic or locally advanced basal cell carcinoma ("BCC")

Metastatic or locally advanced cutaneous squamous cell carcinoma ("CSCC") a a a

Praluent (alirocumab) Injection (3)

Metastatic or recurrent second-line cervical cancer

Praluent (alirocumab) Injection (d)

LDL-lowering in heterozygous familial hypercholesterolemia ("HeFH") or clinical atherosclerotic cardiovascular disease ("ASCVD") a a a

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Homozygous familial hypercholesterolemia ("HoFH") a

REGEN-COV (5)

REGEN-COV ®(f)

COVID-19 a a a

Kevzara (sarilumab) Solution for Subcutaneous Injection (2)

Kevzara (sarilumab) Solution for Subcutaneous Injection (b)

Rheumatoid arthritis ("RA") a a a a

Evkeeza (evinacumab) Injection (6)

- HoFH (in adults and adolescents) a a

Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn) Injection - Infection caused by Zaire ebolavirus

ARCALYST ® (rilonacept) Injection for Subcutaneous Use (7)

Evkeeza (evinacumab) Injection (g)

HoFH (in adults and adolescents) a a a

Inmazeb ® (atoltivimab, maftivimab, and odesivimab-ebgn) Injection

Infection caused by Zaire ebolavirus

ARCALYST ® (rilonacept) Injection for Subcutaneous Use (h)

Cryopyrin-associated periodic syndromes ("CAPS"), including familial cold auto-inflammatory syndrome ("FCAS") and Muckle-Wells syndrome ("MWS") (in adults and adolescents) a

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Recurrent pericarditis (in adults and adolescents)

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (8)

ZALTRAP ® (ziv-aflibercept) Injection for Intravenous Infusion (i)

Metastatic colorectal cancer ("mCRC") a a a a

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 or others.

In addition, unless otherwise noted, products in the table above are approved for use in adults in the above-referenced diseases.

(1) In collaboration with Bayer outside the United States

(2) In collaboration with Sanofi

(3) Pursuant to a 2020 agreement, the Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States (and Sanofi pays us a royalty on net product sales of Praluent outside the United States).

(4) Rest of world ("ROW").

Refer to table below (net product sales of Regeneron-discovered products) for information regarding whether net product sales for a particular product are recorded by us or others.

In addition, unless otherwise noted, products in the table above are generally approved for use in adults in the above-referenced diseases.

(a) In collaboration with Bayer outside the United States

(b) In collaboration with Sanofi

Effective July 2022, the Company is solely responsible for the development, commercialization, and manufacturing of Libtayo.

Refer to "Collaboration, License, and Other Agreements" section below for further details.

(d) The Company is solely responsible for the development and commercialization of Praluent in the United States, and Sanofi is solely responsible for the development and commercialization of Praluent outside of the United States.

(e) Rest of world ("ROW").

A checkmark in this column indicates that the product has received marketing approval in at least one country outside of the United States, European Union ("EU"), or Japan.

(5) Known as REGEN-COV in the United States and Ronapreve in other countries

(f) Known as REGEN-COV in the United States and Ronapreve ™ in other countries.

(g) The Company is solely responsible for the development and commercialization of Evkeeza in the United States.

In January 2022, the Company entered into a license and collaboration agreement for Ultragenyx to develop and commercialize Evkeeza outside of the United States.

Ultragenyx pays us a percentage of net product sales of Evkeeza outside the United States and the Company is also eligible to receive regulatory and sales milestone payments.

(7) Pursuant to a 2017 license agreement with Kiniksa, we granted Kiniksa the right to develop and commercialize certain new indications for ARCALYST.

In March 2021, Kiniksa received marketing approval for its first new indication of ARCALYST in the United States;

consequently we granted U.S.

commercial rights to ARCALYST for all previously approved indications and Kiniksa pays us a share of ARCALYST profits.

(8) Sanofi is solely responsible for the development and commercialization of ZALTRAP, and Sanofi pays us a percentage of aggregate net product sales of ZALTRAP.

REGEN-COV - Emergency and Temporary Use Authorizations

In November 2020, the antibody cocktail casirivimab and imdevimab administered together, known as REGEN-COV in the United States, received Emergency Use Authorization ("EUA") from the U.S.

Food and Drug Administration ("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 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.

In June 2021, the FDA updated the EUA for REGEN-COV, lowering the dose to 1,200 mg (which is half the dose originally authorized) and allowing for subcutaneous injections as an alternative when intravenous ("IV") infusion is not feasible and would lead to a delay in treatment.

In July 2021, the FDA also expanded the EUA to include post-exposure prophylaxis in people at high risk for progression to severe COVID-19, who are not fully vaccinated or are not expected to mount an adequate response to vaccination, and who have been exposed to a SARS-CoV-2 infected individual or are at high risk of exposure to an infected individual because of infection occurring in the same institutional setting (such as in nursing homes or prisons).

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

In January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as Omicron (B.1.1.529) that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S.

states, territories, or jurisdictions, since Omicron is currently the dominant variant across the United States.

If, in the future, patients in certain geographic regions are likely to be infected or exposed to a variant that is susceptible to REGEN-COV, then the limitation on use may be revised in these areas.

Emergency or temporary pandemic use authorizations are also currently in place in numerous other countries outside the United States.

Net Product Sales of Regeneron-Discovered Products

(h) Kiniksa is solely responsible for the development and commercialization of ARCALYST.

(i) Sanofi is solely responsible for the development and commercialization of ZALTRAP.

Net product sales of Regeneron-discovered products consist of the following:

Year Ended December 31,

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$ 199.7 $ 158.3 $ 358.0 $ 161.9 $ 176.1 $ 338.0 $ 141.6 $ 128.3 $ 269.9

$ 18.4 — $ 18.4 — — — — — —

$ 2.2 — $ 2.2 $ 13.1 — $ 13.1 $ 14.5 — $ 14.5

Other products (f)

$ 56.1 $ 69.1 $ 125.2 $ 25.9 $ 86.4 $ 112.3 $ 18.9 $ 97.9 $ 116.8

* Effective January 1, 2022, the Company and Bayer commenced sharing equally in profits and losses based on sales from Bayer to its distributor in Japan.

Previously, the Company received from Bayer a tiered percentage of sales based on sales by Bayer's distributor in Japan.

Consequently, the prior year net product sales amount has been revised for comparability purposes.

(a) Regeneron records net product sales of EYLEA in the United States.

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The Company records its share of profits/losses in connection with sales of EYLEA outside the United States.

(b) Sanofi records global net product sales of Dupixent, Kevzara, and ZALTRAP.

The Company records its share of profits/losses in connection with global sales of Dupixent and Kevzara, and Sanofi pays the Company a percentage of net sales of ZALTRAP.

(c) Regeneron records net product sales of Libtayo in the United States and Sanofi records net product sales of Libtayo outside the United States.

The parties equally share profits/losses in connection with global sales of Libtayo.

(b) Sanofi records global net product sales of Dupixent and Kevzara.

The Company records its share of profits/losses in connection with global sales of Dupixent and Kevzara.

(c) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States.

The parties equally shared profits/losses in connection with global sales of Libtayo.

Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States and pays Sanofi a royalty on global sales.

Refer to "Collaboration, License, and Other Agreements" section below for further details.

Included in this line item is approximately $34 million of net product sales recorded by Sanofi in the second half of 2022 in connection with sales in certain markets (Sanofi will record net product sales in such markets during a transition period until inventory on hand as of July 1, 2022 is sold through to the end customers).

(d) Effective April 1, 2020, Regeneron records net product sales of Praluent in the United States.

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Previously, Sanofi recorded global net product sales of Praluent and the Company recorded its share of profits/losses in connection with such sales.

Refer to "Collaboration, License, and Other Agreements - Sanofi" section below for further details.

(e) Regeneron records net product sales of REGEN-COV in connection with its agreements with the U.S.

Roche records net product sales of the antibody cocktail outside the United States and the parties share gross profits from global sales based on a pre-specified formula.

Refer to "Agreements Related to COVID-19" below for further details.

(f) Regeneron records net product sales of Evkeeza in the United States.

Pursuant to the January 2022 agreement, Ultragenyx will record net product sales of Evkeeza outside of the United States and will pay the Company a percentage of such sales.

Refer to "Products" section above and "Collaboration, License, and Other Agreements - Ultragenyx" section below for further details.

(g) Amounts reflected in the table above represent net product sales recorded by Regeneron.

Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States and pays us a share of ARCALYST profits, if any.

Refer to "Products" section above and "Collaboration, License, and Other Agreements - Kiniksa" section below for further details.

(e) Regeneron records net product sales of REGEN-COV in the United States and Roche records net product sales of Ronapreve outside the United States.

The parties share gross profits from global sales of REGEN-COV and Ronapreve based on a pre-specified formula.

(f) Included in this line item are products which are sold by the Company and others.

Refer to Part II, Item 7.

"Management's Discussion and Analysis of Financial Condition and Results of Operations - Results of Operations - Revenues" for a complete listing of net product sales recorded by the Company.

Not included in this line item are net product sales of ARCALYST subsequent to the first quarter of 2021, which are recorded by Kiniksa.

Programs in Clinical Development

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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 may 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.

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.

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.

"Risk Factors" for a description of risks and uncertainties that may affect our clinical programs.

Any of such risks and uncertainties may, among other matters, negatively impact the development timelines set forth in the table below.

Clinical Program Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 and 2023

Events to Date Select Upcoming Milestones (i)

Events to Date Select Upcoming Milestones

Ophthalmology

EYLEA (aflibercept) (b)

–Retinopathy of prematurity ("ROP") (c)

–ROP (EU and Japan) –Initial results from National Institutes of Health ("NIH")-sponsored Protocol W trial in non-proliferative diabetic retinopathy ("NPDR") were announced;

data confirmed results from Company-sponsored PANORAMA trial and demonstrated reduced risk of developing vision-threatening complications with every-16-weeks dosing regimen

–Completed enrollment in Phase 3 study for ROP

–Submit supplemental BLA ("sBLA") for every-16-weeks dosing regimen in patients with NPDR (first half 2022)

–Report results from Phase 3 study in ROP (second half 2022)

Aflibercept 8 mg (b)

–Wet AMD –Wet AMD

–Completed enrollment in Phase 3 studies in wet AMD and DME

–Reported initial data from Phase 2 trial in wet AMD and that trial met its primary safety and efficacy endpoints

–Report detailed results from Phase 2 trial in wet AMD (first quarter 2022)

–Report results from Phase 3 studies in wet AMD and DME (second half 2022)

Immunology & Inflammation

Dupixent (dupilumab) (a)

Antibody to IL-4R alpha subunit

–Peanut allergy

–Grass allergy –Atopic dermatitis in pediatrics (6 months–5 years of age) (Phase 2/3) (d)

–Eosinophilic esophagitis ("EoE") (c) in adults (d) , adolescents (d) , and pediatrics

–Atopic dermatitis in pediatrics (6 months–5 years of age) (U.S.)

–Asthma in pediatrics (6–11 years of age) (EU)

–EoE in adults and adolescents (U.S.)

–Reported that Phase 3 trial for atopic dermatitis in pediatrics (6 months–5 years of age) met its primary and key secondary endpoints

–Initiated Phase 3 study in hand and foot atopic dermatitis

–Approved by FDA for asthma in pediatrics (6–11 years of age)

–FDA decision on sBLA for atopic dermatitis in pediatric patients (6 months–5 years of age) (mid-2022)

–Submit regulatory application in the EU for atopic dermatitis in pediatric patients (6 months–5 years of age) (first half 2022)

EYLEA (aflibercept) (a)

–ROP (U.S.) –Granted pediatric exclusivity by U.S.

Food and Drug Administration ("FDA") in connection with ROP study, extending period of EYLEA U.S.

market exclusivity by six months through May 17, 2024

–Approved by European Commission ("EC") for ROP

–Approved by Ministry of Health, Labour and Welfare ("MHLW") for ROP in Japan

–Withdrew supplemental Biologics License Application ("sBLA") for every-16-weeks dosing regimen in patients with DR

–FDA decision on sBLA for ROP (target action date of February 11, 2023)

Aflibercept 8 mg (a)

–Wet AMD and DME (U.S.)

–Reported that Phase 3 trials in wet AMD and DME met their primary endpoints

–FDA decision on BLA for wet AMD and DME (third quarter 2023)

–Submit regulatory application in the EU for wet AMD and DME (first quarter 2023)

–Report two-year data from Phase 3 studies in wet AMD and DME (third quarter 2023)

Clinical Program (continued)

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2022 and 2023

Events to Date Select Upcoming Milestones (i)

Dupixent (dupilumab) (a)

Events to Date Select Upcoming Milestones

Immunology & Inflammation

Dupixent (dupilumab) (b)

Antibody to IL-4R alpha subunit

–EoE in pediatrics (c)

–Chronic obstructive pulmonary disease ("COPD")

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–Chronic spontaneous urticaria ("CSU")

–Prurigo nodularis

–Allergic bronchopulmonary aspergillosis ("ABPA")

–Chronic inducible urticaria - cold

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–Allergic fungal rhinosinusitis

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use adopted a positive opinion for severe asthma in pediatrics (6–11 years of age)

– New England Journal of Medicine ("NEJM") published positive results from Phase 3 trial in pediatrics (6–11 years of age) with moderate-to-severe asthma

–Reported that Phase 3 trial in CSU met its primary and key secondary endpoints

–Reported that two Phase 3 trials in prurigo nodularis met their respective primary and key secondary endpoints

–Reported that Part B of the Phase 3 trial in adults and adolescents with EoE met its co-primary endpoints

–Approved by FDA for 200 mg auto-injector

–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

–European Commission ("EC") decision on regulatory submission for asthma in pediatrics (6–11 years of age) (first half 2022)

–Complete rolling sBLA submission for EoE in adults and adolescents (first quarter 2022)

–Report results from Phase 2 study in peanut allergy (second half 2022)

–Report results from additional Phase 3 CSU study (second half 2022)

–Submit sBLA for prurigo nodularis (first half 2022)

–Report results from Phase 3 study in chronic inducible urticaria - cold (second half 2022)

–Chronic pruritus of unknown origin

–Atopic dermatitis in pediatrics (6 months–5 years of age) (EU) and in pediatrics and adolescents (6 months–14 years of age (Japan)

–Prurigo nodularis (Japan)

–CSU in adults and adolescents (U.S.)

–Approved by FDA for atopic dermatitis in pediatrics (6 months–5 years of age)

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for atopic dermatitis in pediatrics (6 months–5 years of age)

–Approved by EC for severe asthma in pediatrics (6–11 years of age)

–Approved by FDA and EC for EoE in adults and adolescents

–Reported that Phase 3 trial in EoE in pediatrics (1–11 years of age) met its primary endpoint

–Approved by FDA and EC for prurigo nodularis

–Stopped one of the Phase 3 trials in CSU (in patients refractory to omalizumab) due to futility, based on pre-specified interim analysis

–Initiated additional Phase 3 trial in CSU (in biologic-naïve patients)

–Discontinued further clinical development in peanut allergy

–EC decision on regulatory submission for atopic dermatitis in pediatrics (6 months–5 years of age) (first half 2023)

–MHLW decision on regulatory submission for atopic dermatitis in pediatrics and adolescents (6 months–14 years of age) in Japan (second half 2023)

–Submit sBLA for EoE in pediatrics (mid-2023)

–Report results from first Phase 3 study in COPD (first half 2023)

–FDA decision on sBLA for CSU in adults and adolescents (second half 2023)

–Report results from Phase 3 study in chronic inducible urticaria - cold (first half 2023)

Clinical Program (continued)

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2022 and 2023

Events to Date Select Upcoming Milestones (i)

Kevzara (sarilumab) (a)

Events to Date Select Upcoming Milestones

Kevzara (sarilumab) (b)

Antibody to IL-6R

–Polyarticular-course juvenile idiopathic arthritis ("pcJIA")

–Systemic juvenile idiopathic arthritis ("sJIA")

Itepekimab (a) (REGN3500)

–Systemic juvenile idiopathic arthritis ("sJIA") –Polymyalgia rheumatica ("PMR") (U.S.) –FDA decision on sBLA for PMR (target action date of February 28, 2023)

Itepekimab (b) (REGN3500)

Antibody to IL-33

REGN1908-1909 (f)

Multi-antibody therapy to Fel d 1

–Cat allergy –Reported that Phase 2 study in cat allergic patients with mild asthma met its primary and key secondary endpoints

–COPD –Report results from Phase 3 study in COPD (2024)

REGN5713-5714-5715

Multi-antibody therapy to Bet v 1

–Birch allergy –Initial Phase 3 study in birch allergic patients with allergic rhinoconjunctivitis met its primary endpoint

Antibody to IL-36R

–Palmo-plantar pustulosis

–Birch allergy

Solid Organ Oncology

Libtayo (cemiplimab) (a)(g)

Libtayo (cemiplimab) (n)(g)

Antibody to PD-1

–Metastatic or locally advanced CSCC (d)

–Neoadjuvant CSCC

–Second-line cervical cancer, ISA101b combination

–First-line NSCLC, chemotherapy combination

–Second-line cervical cancer (e)

–Adjuvant CSCC

–Second-line cervical cancer (EU)

–First-line NSCLC, chemotherapy combination (U.S.

–Approved by FDA and EC for first-line NSCLC, monotherapy

–Approved by FDA and EC for BCC

–Reported Phase 3 chemotherapy combination trial in NSCLC met its overall survival primary endpoint;

trial stopped early based on Independent Data Monitoring Committee ("IDMC") recommendation –FDA decision on sBLA (target action date of September 19, 2022) and EC decision on regulatory submission for NSCLC, chemotherapy combination (second half 2022)

–EC decision on regulatory submission for cervical cancer (second half 2022)

–First-line NSCLC, chemotherapy combination (EU)

–Approved by FDA in combination with chemotherapy for NSCLC

–Approved by EC and MHLW for cervical cancer

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies

–Positive data from Phase 2 trial in neoadjuvant CSCC presented at European Society for Medical Oncology ("ESMO") Congress 2022 and published in New England Journal of Medicine

–EC decision on regulatory submission for NSCLC, chemotherapy combination (first half 2023)

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma

–First-line adjuvant melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at ESMO Congress 2022

–Initiate Phase 3 study (in combination with Libtayo) in perioperative melanoma (mid-2023)

Clinical Program (continued)

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2022 and 2023

Events to Date Select Upcoming Milestones (i)

Libtayo (cemiplimab) (a)(g)

–Reported positive results from Phase 3 trial in cervical cancer, demonstrating an overall survival benefit;

trial stopped early based on IDMC recommendation

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies

Events to Date Select Upcoming Milestones

Fianlimab (f)

–Positive initial data from Phase 1 trial (in combination with Libtayo) in NSCLC presented at ESMO Immuno-Oncology Congress 2022

–Initiate Phase 2/3 studies (in combination with Libtayo) in first-line advanced NSCLC (first half 2023)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (second half 2023)

Immune activator targeting TLR9

–Solid tumors –Initiate Phase 2 study in melanoma

Ubamatamab (f)

Bispecific antibody targeting MUC16 and CD3

–Platinum-resistant ovarian cancer –Report results from Phase 1 study in platinum-resistant ovarian cancer (2022)

–Platinum-resistant ovarian cancer –Presented positive initial data from monotherapy dose escalation portion of Phase 1/2 study in platinum-resistant ovarian cancer at ESMO Congress 2022

–Report results from Phase 1/2 study (in combination with Libtayo) in platinum-resistant ovarian cancer (2023)

Bispecific antibody targeting MUC16 and CD28

–Ovarian cancer

–Platinum-resistant ovarian cancer

Bispecific antibody targeting PSMA and CD28

–Prostate cancer –Report results from Phase 1 study in prostate cancer (2022)

–Prostate cancer –Reported preliminary data from dose escalation portion of Phase 1/2 study (in combination with Libtayo) in prostate cancer

–Report additional results from Phase 1/2 study (in combination with Libtayo) in prostate cancer (2023)

Bispecific antibody targeting PSMA and CD3

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Bispecific antibody targeting two distinct MET epitopes

–MET-altered advanced NSCLC

–MET-altered advanced NSCLC –Presented positive initial data from dose escalation portion of Phase 1/2 study in MET-altered advanced NSCLC at ESMO Congress 2022

REGN5093-M114

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–MET overexpressing advanced cancer

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –Presented positive data from Phase 1 trial in combination with Libtayo in advanced melanoma at American Society of Clinical Oncology Annual Meeting

–Initiate Phase 3 study in first-line metastatic melanoma (first half 2022)

Antibody to GITR

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2022 and 2023

Events to Date Select Upcoming Milestones (i)

Events to Date Select Upcoming Milestones

Bispecific antibody targeting EGFR and CD28

–Solid tumors

Odronextamab (REGN1979)

Odronextamab (i) (REGN1979)

Bispecific antibody targeting CD20 and CD3

–Certain B-cell malignancies (c)

–B-cell non-Hodgkin lymphoma ("B-NHL") (potentially pivotal study) –Resumed enrollment of patients with follicular lymphoma ("FL") and diffuse large B-cell lymphoma ("DLBCL") following protocol amendments –Report additional results from potentially pivotal Phase 2 study in B-NHL (2022)

–Initiate Phase 3 program (second half 2022)

–Certain B-cell malignancies (c)(m)

–B-cell non-Hodgkin lymphoma

("B-NHL") (m) (pivotal study)

–Presented positive data from two cohorts of pivotal Phase 2 study in patients with diffuse large B-cell lymphoma ("DLBCL") and follicular lymphoma ("FL") at American Society of Hematology ("ASH") Annual Meeting

–Initiate Phase 3 studies in FL and DLBCL, including earlier lines of therapy (first half 2023)

–Submit BLA for relapsed/refractory FL and DLBCL (second half 2023)

Linvoseltamab (f)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (potentially pivotal study) –Presented results for higher dose level cohorts from Phase 1 trial in multiple myeloma at American Society of Hematology ("ASH") Annual Meeting –Complete enrollment in potentially pivotal Phase 2 study in multiple myeloma (first quarter 2022)

–Report results from potentially pivotal Phase 2 study in multiple myeloma (second half 2022)

–Expand into earlier lines of multiple myeloma therapy (first half 2022)

–Multiple myeloma (c)

–Multiple myeloma (pivotal study) (c)

–Completed enrollment in pivotal Phase 2 study in multiple myeloma

–Presented positive data from pivotal Phase 2 study in multiple myeloma at ASH Annual Meeting

–Initiate Phase 3 study in multiple myeloma, including earlier lines of therapy (first half 2023)

–Submit BLA for relapsed/refractory multiple myeloma (second half 2023)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma

–Transplant desensitization in patients with chronic kidney disease

Pozelimab (f) (REGN3918)

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studied as monotherapy and in combination with cemdisiran

–CD55-deficient protein-losing enteropathy (c) , monotherapy (potentially pivotal study)

–Myasthenia gravis, cemdisiran combination (n)

–Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(n)

–Submit BLA for CD55-deficient protein-losing enteropathy, monotherapy (second half 2022)

Cemdisiran (n)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

–CD55-deficient protein-losing enteropathy ("CHAPLE"), monotherapy (c)(e) (potentially pivotal study)

–Myasthenia gravis, cemdisiran combination (k)

–Paroxysmal nocturnal hemoglobinuria ("PNH"), cemdisiran combination (c)(k)

–CHAPLE, monotherapy (U.S.)

–FDA decision on BLA for CHAPLE, monotherapy (second half 2023)

Antibody to IL2Rg

–Aplastic anemia

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2021 and 2022

Events to Date Select Upcoming Milestones (i)

NTLA-2001 (m)

NTLA-2001 (j)

TTR gene knockout using CRISPR/Cas9

–Transthyretin amyloidosis

–Reported positive interim data from Phase 1 trial in hereditary transthyretin amyloidosis with polyneuropathy

–Transthyretin ("ATTR") amyloidosis (c)

–Reported positive interim data from Phase 1 trial in ATTR

Antibody to Factor XI

General Medicine

REGEN-COV (casirivimab and imdevimab) (e)(k)(l)

Multi-antibody therapy to SARS-CoV-2 virus

–COVID-19 treatment in hospitalized patients

–COVID-19 prevention

–COVID-19 treatment and prevention (U.S.)

–EUA amendment to add COVID-19 treatment for hospitalized patients and pre-exposure prophylaxis –Reported that Phase 3 trials in non-hospitalized COVID-19 patients met primary and key secondary endpoints

–Reported that Phase 3 trial in hospitalized COVID-19 patients met its primary endpoint

–Positive results reported from Phase 3 RECOVERY trial in hospitalized patients

–Reported that all tested doses in Phase 2 dose-ranging study in non-hospitalized patients met its primary endpoint

–FDA updated EUA, lowering dose to 1,200 mg, allowing for subcutaneous injections in certain circumstances, and to include post-exposure prophylaxis

–FDA revised EUA to exclude use in geographic regions where infection or exposure is likely due to a variant that is not susceptible to the treatment –FDA decision on BLA (target action date of April 13, 2022) for COVID-19 treatment of non-hospitalized patients and prevention

–Submit sBLA and Marketing Authorization Application ("MAA") for COVID-19 treatment of hospitalized patients (first half 2022)

Clinical Program (continued)

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2022 and 2023

Events to Date Select Upcoming Milestones (i)

REGEN-COV (casirivimab and imdevimab) (e)(k)(l)

–Approved by EC for COVID-19 treatment of non-hospitalized patients and prevention and by Ministry of Health, Labour and Welfare ("MHLW") for COVID-19 treatment in Japan

–Reported that Phase 3 prevention trial in uninfected household contacts of SARS-CoV-2 infected individuals met its primary and key secondary endpoints

–Reported positive longer-term results from Phase 3 prevention trial

Events to Date Select Upcoming Milestones

Antibody to Factor XI

Antibody to TMPRSS6

–Transfusion dependent iron overload

General Medicine

"Next Generation" Covid Antibodies

Antibodies to SARS-CoV-2 variants

–Initiate clinical development of "next generation" antibody

Praluent (alirocumab)

Antibody to PCSK9

–HeFH in pediatrics –Approved by FDA for HoFH

Fasinumab (j)(f) (REGN475)

Antibody to NGF

–Osteoarthritis pain of the knee or hip (e)

–Continue discussions with regulatory authorities and determine next steps for the program (mid-2022)

Evkeeza (evinacumab) (f)(o)

–HeFH in pediatrics –Submit sBLA for HeFH in pediatrics (mid-2023)

Evkeeza (evinacumab) (f)(l)

Antibody to ANGPTL3

–Acute pancreatitis prevention –Approved by FDA and EC for HoFH

–Completed Phase 2 study in severe hypertriglyceridemia

–HoFH in pediatrics (5–11 years of age) (U.S.)

–Reported that Phase 3 trial for HoFH in pediatrics (5–11 years of age) met its primary endpoint

–FDA decision on sBLA for HoFH in pediatrics (5–11 years of age) (target action date of March 30, 2023)

Garetosmab (f) (REGN2477)

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("FOP") (c)(d)(e)

–Determine next steps for the program (2022)

Mibavademab (f)

Agonist antibody to leptin receptor ("LEPR")

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–Partial lipodystrophy

–Report results from Phase 2 study in generalized lipodystrophy (first half 2022)

Agonist antibody to NPR1

–Heart failure

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure –Report initial data in healthy volunteers (2023)

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

("NASH") –Reported preliminary data from Phase 1 study in NASH

–Initiate Phase 2 study in NASH (first quarter 2023)

RNAi therapeutic targeting PNPLA3

RNAi therapeutic targeting APP

–Early-onset Alzheimer’s disease –Report results from Phase 1 study in early-onset Alzheimer’s disease (mid-2023)

For purposes of the table above, a program is classified in Phase 1, 2, or 3 clinical development after recruitment for the corresponding study or studies has commenced.

(a) In collaboration with Sanofi

(b) In collaboration with Bayer outside of the United States

We have discontinued further clinical development of fasinumab (REGN475), an antibody to NGF, which was previously being studied in osteoarthritis pain of the knee or hip in collaboration with Teva and Mitsubishi Tanabe Pharma Corporation ("MTPC");

REGN6490, an antibody to IL-36R, which was previously being studied in palmo-plantar pustulosis;

and the Phase 3 study of REGN1908-1909, a multi-antibody therapy to Fel d 1, in cat allergy, due to futility.

(a) In collaboration with Bayer outside the United States

(b) In collaboration with Sanofi

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(h) Information in this column relates to U.S., EU, and Japan regulatory submissions only

(i) As described in the section preceding the table above and Part I, Item 1A.

"Risk Factors," development timelines may be further subject to change as a result of the impact of the COVID-19 pandemic.

(j) In collaboration with Teva and Mitsubishi Tanabe Pharma

(k) Certain trials conducted with the National Institute of Allergy and Infectious Diseases ("NIAID"), part of the NIH

(l) In collaboration with Roche outside of the United States

(m) In collaboration with Intellia

(n) In collaboration with Alnylam

(o) In collaboration with Ultragenyx outside of the United States

(i) In collaboration with Zai Lab in mainland China, Hong Kong, Taiwan, and Macau

(j) In collaboration with Intellia

(k) In collaboration with Alnylam

(l) In collaboration with Ultragenyx outside the United States

(m) FDA granted Fast Track designation for follicular lymphoma and diffuse large B-cell lymphoma

(n) In collaboration with Sanofi prior to July 2022.

Effective July 2022, the Company is solely responsible for the research, development, and commercialization of Libtayo.

Refer to "Collaboration, License, and Other Agreements" section below for further details.

(o) Studied in combination with ubamatamab

(p) Alnylam elected to opt-out of the product candidate.

Under the terms of our agreement, Alnylam is entitled to receive royalties on sales of the product, if any.

Additional Information - Clinical Development Programs

Aflibercept 8 mg

In September 2022, the Company announced that the primary endpoints were met in two pivotal trials investigating aflibercept 8 mg with 12- and 16-week dosing regimens in patients with DME and wet AMD.

The PHOTON trial in DME and the PULSAR trial in wet AMD both demonstrated that aflibercept 8 mg 12- and 16-week dosing regimens achieved non-inferiority in vision gains compared to the EYLEA 8-week dosing regimen.

Furthermore, of the patients randomized to 12- and 16-week dosing intervals, 91% and 89% of DME patients, respectively, and 79% and 77% of wet AMD patients, respectively, maintained those intervals through 48 weeks.

The safety of aflibercept 8 mg was similar to EYLEA in both trials, and consistent with the known safety profile of EYLEA from previous clinical trials.

The Company is utilizing a priority review voucher in connection with the December 2022 submission of the BLA for DME and wet AMD.

REGEN-COV (casirivimab and imdevimab)

Based on laboratory data that showed markedly decreased binding to the Omicron spike protein, REGEN-COV is highly unlikely to be active against the Omicron variant.

See "REGEN-COV - Emergency and Temporary Use Authorizations" above for further information.

The Company has completed or discontinued dosing with REGEN-COV in all COVID-19 treatment and prevention studies.

However, the Company continues to progress "next generation" antibodies that are active against Omicron, Delta, and other variants of concern.

Pending regulatory discussions, new therapeutic candidates could enter clinical development in the coming months.

REGEN-COV Treatment Study - Hospitalized Patients

The Phase 3 UK-based RECOVERY trial in hospitalized patients with severe COVID-19 found that adding REGEN-COV to usual care reduced the risk of death by 20% in patients who had not mounted a natural antibody response on their own against SARS-CoV-2, compared to usual care alone.

We were subsequently notified by the sponsor of the RECOVERY trial of a Good Clinical Practices ("GCPs") inspection of the trial by the UK MHRA, which found certain deviations from GCP compliance.

The MHRA report stated that it found no evidence that the identified issues had impacted the overall data integrity to such an extent that the data would be unreliable based on those findings.

However, it noted that certain aspects of data quality could not be fully assured and requested that certain corrective and preventative actions be taken;

the sponsor of the trial has been in discussions with the MHRA and is responding to these findings.

We have shared this information with the FDA.

In the Company-sponsored Phase 2/3 study in hospitalized patients, REGEN-COV met the primary virologic endpoint, showing that REGEN-COV reduced viral load in these hospitalized patients, but did not achieve statistical significance in the pre-specified primary clinical endpoint:

reduction in mechanical ventilation or death from day 6 to day 29 in patients with high viral load at baseline.

However, the study showed a reduction in mechanical ventilation or death from day 1 to day 29 in all patients who were SARS-CoV-2 PCR-positive at baseline.

In addition, an approximately 36% reduction in all-cause mortality was seen from day 1 to day 29, supporting the results of the RECOVERY trial.

In September 2021, the Company announced that a Phase 3 trial in patients hospitalized with COVID-19 met its primary endpoint.

The trial showed that REGEN-COV significantly reduced viral load within 7 days of treatment in patients who entered the trial without having mounted their own antibody response (seronegative) and required low-flow or no supplemental oxygen.

Patients who received REGEN-COV in this trial experienced a 36% reduced risk of death within 29 days of receiving treatment, and in patients who were seronegative when they entered the trial the risk of death was reduced by 56%.

REGEN-COV Prevention Study

In April 2021, we announced positive results from the Phase 3 COVID-19 prevention trial in household contacts of SARS-CoV-2 infected individuals.

The trial, which was jointly run with the NIAID, part of the NIH, met its primary and key secondary endpoints, showing that REGEN-COV 1,200 mg subcutaneous injection reduced the risk of symptomatic infections by 81% in those who were not infected.

In November 2021, we announced additional positive results from the Phase 3 COVID-19 prevention trial jointly run with the NIAID, showing the a single dose of REGEN-COV reduced the risk of contracting COVID-19 by 81.6% during the pre-specified follow-up period (months 2–8), maintaining the risk reduction reported during the first month after administration, which is described above.

REGEN-COV, a multi-antibody therapy to SARS-CoV-2 virus, previously received an EUA for use in certain post-exposure prophylaxis settings and as a treatment for people with mild to moderate COVID-19 who are at high risk of serious consequences from COVID-19.

Based on laboratory data, in January 2022, the FDA revised the EUA for REGEN-COV to exclude its use in geographic regions where, based on available information including variant susceptibility and regional variant frequency, infection or exposure is likely due to a variant such as an Omicron-lineage variant that is not susceptible to the treatment.

With this EUA revision, REGEN-COV is not currently authorized for use in any U.S.

states, territories, or jurisdictions, since Omicron-lineage variants are currently dominant across the United States.

In December 2022, the FDA issued a complete response letter ("CRL") on the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals.

Descriptions of Marketed Products Studied in Additional Indications and Product Candidates in Late-Stage Clinical Development

EYLEA (aflibercept)

EYLEA (2 mg intravitreal injection) is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor, formulated as an injection for the eye.

EYLEA is a soluble fusion protein that acts as a vascular endothelial growth factor ("VEGF") inhibitor, formulated as a 2 mg intravitreal injection for the eye.

It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and PLGF, two growth factors involved in angiogenesis.

Aflibercept 8 mg

Aflibercept 8 mg is an investigational soluble fusion protein that acts as a VEGF inhibitor (see related description under "EYLEA (aflibercept)" above).

This concentrated aflibercept formulation is being studied in wet AMD and DME, investigating dosing intervals of every 12 weeks and every 16 weeks.

Aflibercept 8 mg is an investigational soluble fusion protein that acts as a VEGF inhibitor.

Through a novel formulation, it is designed to deliver a concentrated dose of aflibercept to block VEGF-A and PLGF and inhibit the growth of new blood vessels and decrease vascular permeability.

Aflibercept 8 mg is being studied in wet AMD and DME using extended dosing intervals of every 12 weeks and every 16 weeks.

Dupixent (dupilumab)

Dupixent is a fully human monoclonal antibody that inhibits signaling of the IL-4 and IL-13 pathways, and is not an immunosuppressant.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, and CRSwNP, and potentially other chronic allergic diseases.

IL-4 and IL-13 are key and central drivers of the type 2 inflammation that plays a major role in atopic dermatitis, asthma, CRSwNP, EoE, prurigo nodularis, and potentially other chronic allergic and inflammatory diseases.

Kevzara (sarilumab)

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REGN5713-5714-5715

REGN1908-1909 is an investigational, novel cocktail of two fully human monoclonal immunoglobulin G antibodies that is designed to specifically bind and block the Fel d 1 allergen, thus preventing it from binding and triggering the endogenous antibodies that cause allergies (i.e., immunoglobulin E antibodies).

Cat allergy is primarily caused by exposure to Fel d 1, the major allergen in cat dander produced by all cats.

REGN5713-5714-5715

REGN5713-5714-5715 is an investigational combination of three fully human monoclonal antibodies designed to treat allergic inflammatory conditions caused by the allergen Betv1, which is the main allergen responsible for birch pollen allergies.

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It is also being studied in combination with proprietary anti-cancer assets of other companies.

Fianlimab is an investigational, fully human monoclonal antibody targeting the immune checkpoint receptor LAG-3 on T-cells.

In melanoma, LAG-3 expression in the tumor microenvironment may be associated with therapeutic resistance to PD-1 inhibitors.

Fianlimab is being investigated in combination with Libtayo to determine whether concurrent blockade of LAG-3 and PD-1 can help overcome this resistance and release the brakes on T-cell activation.

Odronextamab is an investigational bispecific monoclonal antibody designed to bind to a component of the T-cell receptor ("TCR") complex (CD3), while also binding and bridging T-cells to a protein expressed on B-cells (CD20).

We are studying whether odronextamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of cancerous cells in several types of B-cell non-Hodgkin lymphoma.

REGN5458 is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells.

We are studying whether REGN5458 may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.

Pozelimab is an investigational, fully human monoclonal antibody designed to block complement factor C5 in order to treat diseases mediated by abnormal complement pathway activity, including PNH, CD55-deficient protein-losing enteropathy, and myasthenia gravis.

Pozelimab is being studied as monotherapy and also in combination with Alnylam’s investigational siRNA therapy, cemdisiran.

REGEN-COV (casirivimab and imdevimab)

REGEN-COV is an investigational cocktail of two fully human monoclonal antibodies designed to prevent and treat infection from the SARS-CoV-2 virus.

The two potent, virus-neutralizing antibodies that form the cocktail bind non-competitively to the critical receptor binding domain of the virus's spike protein.

Linvoseltamab

Linvoseltamab is an investigational bispecific monoclonal antibody designed to bind to CD3 while also binding and bridging T-cells to the BCMA protein on multiple myeloma cells.

We are studying whether linvoseltamab may help to activate T-cells via their CD3 receptors and trigger targeted, T-cell mediated killing of multiple myeloma.

Pozelimab is being studied as monotherapy and also in combination with Alnylam’s investigational small interfering RNA ("siRNA") therapy, cemdisiran.

Praluent (alirocumab)

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Through inhibiting PCSK9, Praluent increases the number of available LDL receptors on the surface of liver cells to clear LDL, which lowers LDL cholesterol levels in the blood.

Fasinumab is an investigational, fully human monoclonal antibody that targets NGF, a protein that plays a central role in the regulation of pain signaling, and is a potential new way to manage pain without resorting to opioids.

Evkeeza (evinacumab)

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ANGPTL3 plays a key role in regulating plasma lipid levels, including triglycerides, LDL cholesterol, and HDL cholesterol, through inhibition of lipase enzymes (lipoprotein lipase and endothelial lipase).

Garetosmab is an investigational, fully-human monoclonal antibody that binds to and neutralizes Activin A, which drives the abnormal bone formation that is the main pathology of the ultra-rare genetic disorder FOP.

This abnormal bone formation in soft tissue outside of the normal skeleton, a process known as heterotopic ossification, leads to loss of mobility and premature death in FOP patients.

Garetosmab is being investigated to determine whether it can help reduce and/or prevent the formation of heterotopic bone lesions by neutralizing the Activin A protein.

Other Programs

Our preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, cardiovascular diseases, infectious diseases, diseases related to aging, and rare diseases.

Our preclinical research programs include the areas of oncology/immuno-oncology, angiogenesis, ophthalmology, metabolic and related diseases, muscle diseases and disorders, inflammation and immune diseases, bone and cartilage, pain and neurobiology, auditory conditions, enzyme replacement therapy, cardiovascular diseases, infectious diseases, and diseases related to aging.

These preclinical research programs include both rare diseases and those involving broader populations.

Research and Development Technologies

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The VelocImmune mouse platform is utilized to produce fully human antibodies.

VelocImmune was generated by leveraging our VelociGene technology (see below), in a process in which six megabases of mouse immune gene loci were replaced, or "humanized," with corresponding human immune gene loci.

VelocImmune was generated by leveraging our VelociGene technology (see below), in a process in which six megabases of mouse immunoglobulin gene loci were replaced, or "humanized," with corresponding human immunoglobulin gene loci.

VelocImmune mice can be used efficiently to generate fully human antibodies to targets of therapeutic interest.

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In producing knock-out models, a color or fluorescent marker may be substituted in place of the actual gene sequence, allowing for high-resolution visualization of precisely where the gene is active in the body during normal body functioning as well as in disease processes.

For the optimization of preclinical development and pharmacology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog.

For the optimization of preclinical development and pharmacology programs, VelociGene offers the opportunity to humanize targets by replacing the mouse gene with the human homolog or variants thereof.

Thus, VelociGene allows scientists to rapidly identify the physical and biological effects of deleting or over-expressing the target gene, as well as to characterize and test potential therapeutic molecules.

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Furthermore, mice developed using our VelociMouse technology are suitable for direct phenotyping or other studies.

We have also developed our

VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for our Traps and our VelocImmune human antibodies.

We have also developed our VelociMab platform for the rapid screening of antibodies and rapid generation of expression cell lines for our Traps and our VelocImmune human antibodies.

We have utilized our VelociSuite technologies to develop a class of potential drug candidates, known as bispecific antibodies.

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We are exploring additional indications and applications for our bispecific technologies, including a new class of CD28 and 4-1BB costimulatory bispecifics.

We are also exploring a variety of alternative antibody formats (Altibodies ™ ) that can bring binding partners together in restrained geometries.

The VelociT mouse extends our research and drug discovery capabilities into cell-mediated immunity and therapeutic TCRs for oncology and other indications.

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Regeneron Genetics Center ®

Regeneron Genetics Center (RGC ™ ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and molecular data from human volunteers to identify medically relevant associations in a blinded fashion designed to preserve patients' privacy.

Regeneron Genetics Center LLC (RGC ™ ), a wholly owned subsidiary of Regeneron Pharmaceuticals, Inc., leverages de-identified clinical, genomic, and other types of molecular data from properly consented human volunteers from around the world to identify medically relevant associations in a blinded fashion designed to preserve a patients' privacy while uncovering the unique characteristics of their health and wellness.

The objective of RGC is to expand the use of human genetics for discovering and validating genetic factors that cause or influence a range of diseases where there are major unmet medical needs, with the prospect of improving the drug discovery and development process and to advance innovation in clinical care design.

RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts as well as family- and founder-based approaches.

RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput.

Central to the work of RGC is the portfolio of collaborations with over 100 academic and clinical collaborators around the world, including the University of Colorado, Geisinger Health System, Mayo Clinic, University of Pennsylvania, UCLA Medical Center, UK Biobank, and the University of Helsinki.

These collaborations provide access to biological samples and associated phenotype data from consented patient volunteers for purposes of genomic research.

RGC is undertaking multiple collaborative approaches to study design and implementation, including large population-based efforts that engage study participants to more discrete disease specific and founder populations with data on strategic phenotypes of interest.

RGC utilizes laboratory automation and innovative approaches to cloud computing to achieve high-quality throughput, attaining approximately 2 million samples sequenced to date.

These collaborations provide access to biological samples and associated phenotype data from properly consented patient volunteers for purposes of genomic research.

RGC undertakes genetic sequencing of these samples to create a unique resource of de-identified genetic data and associated phenotype data for research.

Furthermore, the RGC has deployed bulk RNA sequencing, whole genome sequencing, and an O-LINK proteomic assay to complement whole exome sequencing and genotyping.

In addition, the RGC leverages organoid models, silencing RNA ("siRNA"), and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.

The RGC continues to publish results from its research efforts in journals and publications in collaboration with its collaborators to advance the field of genomics.

In addition, the RGC leverages organoid models, siRNA, and CRISPR knockout models to validate genetic associations that lead to new therapeutic targets.

The RGC continues to publish results from its research efforts in journals and publications in partnership with its collaborators to advance the field of genomics.

These efforts at the RGC have led to the identification of more than 20 novel genetic targets.

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Agreements Related to COVID-19

In the first quarter of 2020, the Company announced an expansion of its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

In 2020, the Company expanded its Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S.

Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.

In July 2020, the Company entered into an agreement with entities acting at the direction of BARDA and the U.S.

In 2020, the Company also entered into an agreement with entities acting at the direction of BARDA and the U.S.

Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S.

The agreement, as subsequently amended, provided for payments to the Company of up to $465.9 million in the aggregate for bulk manufacturing of the drug substance, as well as fill/finish, storage, and other activities.

In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S.

In January 2021, the Company entered into an agreement with the U.S.

Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S.

Pursuant to the agreement, the U.S.

government was obligated to purchase 1.25 million doses of drug product, resulting in payments to the Company of $2.625 billion (as described under "Products - REGEN-COV - Emergency and Temporary Use Authorizations" above).

In September 2021, the Company announced an amendment to its January 2021 agreement to supply the U.S.

government was obligated to purchase 1.25 million doses of drug product, resulting in payments to the Company of $2.625 billion.

In September 2021, the Company entered into an amendment to its January 2021 agreement to supply the U.S.

government with an additional 1.4 million doses of REGEN-COV.

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As of December 31, 2021, the Company had completed its final deliveries of drug product under the agreements described above.

See "Results of Operations - Revenues" below for REGEN-COV net product sales recognized in connection with these agreements.

In August 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail.

We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19.

Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year.

We distribute the product in the United States and Roche distributes the product outside of the United States.

In 2020, we entered into a collaboration agreement with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve in other countries).

We have the right to distribute the product in the United States and Roche has the right to distribute the product outside of the United States.

The parties share gross profits from worldwide sales based on a pre-specified formula, depending on the amount of manufactured product supplied by each party to the market.

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We are collaborating with Sanofi on the global development and commercialization of Dupixent, Kevzara, and itepekimab (the "Antibody Collaboration").

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80%–100% of agreed-upon development costs.

We are obligated to reimburse Sanofi for 30%–50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits from commercialization of collaboration products.

However, we are only required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

Under the terms of the Antibody License and Collaboration Agreement (the "LCA"), Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs.

We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits from commercialization of collaboration products.

Under the terms of the LCA, we were required to apply 10% of our share of the profits from the Antibody Collaboration in any calendar quarter to reimburse Sanofi for these development costs.

On July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of Regeneron’s share of profits used to reimburse Sanofi for such development costs increased from 10% to 20%.

Under our collaboration agreement, Sanofi records product sales for commercialized products, and Regeneron has the right to co-commercialize such products on a country-by-country basis.

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We and Sanofi share profits outside the United States on a sliding scale based on sales starting at 65% (Sanofi)/35% (us) and ending at 55% (Sanofi)/45% (us), and share losses outside the United States at 55% (Sanofi)/45% (us).

In addition to profit and loss sharing, we are entitled to receive sales milestone payments from Sanofi.

In each of 2020 and 2021, the Company earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-

We are entitled to receive up to an aggregate of $150.0 million in additional sales milestone payments from Sanofi, which includes the next sales milestone payment of $50.0 million that would be earned when such sales outside the United States exceed $2.0 billion on a rolling twelve-month basis.

In each of 2020 and 2021, we earned a $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion and $1.5 billion, respectively, on a rolling twelve-month basis.

In 2022, we earned two additional $50.0 million sales-based milestones, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $2.0 billion and $2.5 billion, respectively, on a rolling twelve-month basis.

We are entitled to receive the final sales milestone payment of $50.0 million when such sales outside the United States exceed $3.0 billion on a rolling twelve-month basis.

In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA.

The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, is solely responsible for the development and commercialization of Praluent outside of the United States.

Under the Praluent Agreement, Sanofi will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Under the Praluent Agreement, Sanofi pays the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032.

The Company does not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States.

Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron.

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Immuno-Oncology

We are collaborating with Sanofi on the development and commercialization of antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

Effective December 31, 2018, the Company and Sanofi entered into an Amended and Restated Immuno-oncology Discovery and Development Agreement (the "Amended IO Discovery Agreement"), which narrowed the scope of the existing discovery and development activities conducted by the Company ("IO Development Activities") under the original 2015 Immuno-oncology Discovery and Development Agreement (the "2015 IO Discovery Agreement") to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept.

The Amended IO Discovery Agreement provided for, among other things, Sanofi's prepayment for certain IO Development Activities regarding the BCMAxCD3 Program and the MUC16xCD3 Program.

Under the terms of the Amended IO Discovery Agreement, the Company was required to conduct development activities with respect to (i) the BCMAxCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $70.0 million (the "BCMAxCD3 Program Costs Cap") and (ii) the MUC16xCD3 Program through the earlier of clinical proof-of-concept or the expenditure of $50.0 million (the "MUC16xCD3 Program Costs Cap").

We are obligated to reimburse Sanofi for half of the development costs they funded that are attributable to clinical development of antibody product candidates under the Amended IO Discovery Agreement from our share of profits from commercialized IO Collaboration products.

With regard to the BCMAxCD3 Program and the MUC16xCD3 Program, when the applicable Program Costs Cap was reached, Sanofi had the option to license rights to the product candidate and other antibodies targeting the same targets for, with regard to BCMAxCD3, immuno-oncology indications, and with regard to MUC16xCD3, all indications, pursuant to the Immuno-oncology License and Collaboration Agreement (the "IO License and Collaboration Agreement"), as amended.

During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates;

as a result, we retain the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any).

Under the terms of the IO License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo.

We have principal control over the development of Libtayo, and the parties share equally, on an ongoing basis, development and commercialization expenses for Libtayo.

With regard to Libtayo, we lead commercialization activities in the United States, while Sanofi leads commercialization activities outside of the United States and the parties equally share profits from worldwide sales.

Sanofi has exercised its option to co-commercialize Libtayo in the United States.

We will be entitled to a milestone payment of $375.0 million in the event that global sales of Libtayo equal or exceed $2.0 billion in any consecutive twelve-month period.

EYLEA and aflibercept 8 mg outside the United States

We previously collaborated with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration").

Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo.

The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo.

We had principal control over the development of Libtayo and led commercialization activities in the United States, while Sanofi led commercialization activities outside of the United States.

The parties shared equally in profits and losses in connection with the commercialization of Libtayo.

Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA").

In connection with the A&R IO LCA, in 2022, the Company made a $900.0 million up-front payment to Sanofi, as well as a $100.0 million regulatory milestone payment.

In addition, Sanofi earned a $65.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2022, and is eligible to receive an additional $35.0 million sales-based milestone upon the achievement of a specified amount of worldwide net product sales of Libtayo in 2023.

Sanofi an 11% royalty on net product sales of Libtayo through March 31, 2034.

The parties have also entered into a transition services agreement, a transitional distribution agreement, and a manufacturing services agreement, pursuant to which, during certain transitional periods, Sanofi will perform for Regeneron certain transition, distribution, and manufacturing services, respectively.

Under the Amended and Restated Immuno-oncology Discovery and Development Agreement, we were obligated to reimburse Sanofi for half of the development costs it funded that were attributable to clinical development of product candidates from our share of profits from commercialized IO Collaboration products.

Under the A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi was $35.0 million as of the effective date of the A&R IO LCA, and we pay Sanofi a 0.5% royalty on net product sales of Libtayo until all such development costs have been reimbursed by us.

We and Bayer are parties to a license and collaboration agreement for the global development and commercialization of EYLEA and aflibercept 8 mg outside the United States.

All agreed-upon development expenses incurred by the Company and Bayer are shared equally.

Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales.

In Japan, we were entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales through 2021, and thereafter, the companies share equally in profits and losses from sales.

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits (including payments to us based on sales in Japan).

Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.

Bayer markets EYLEA outside the United States, and the companies share equally in profits and losses from such sales.

In Japan, we were entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net sales through 2021, and, effective January 1, 2022, the companies share equally in profits and losses from sales.

We are obligated to reimburse Bayer for 50% of the development costs that it has incurred under the agreement from our share of the collaboration profits.

The reimbursement payment in any quarter will equal 5% of the then outstanding repayment obligation, but never more than our share of the collaboration profits in the quarter unless we elect to reimburse Bayer at a faster rate.

Within the United States, we retain exclusive commercialization rights and are entitled to all profits from such sales.

We and Teva are parties to a collaboration agreement to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation ("MTPC").

In connection with the agreement, Teva made a $250.0 million non-refundable up-front payment.

We lead global development activities, and the parties share equally, on an ongoing basis, development costs under a global development plan.

As of December 31, 2021, we had received an aggregate $120.0 million of development milestones from Teva, and we are entitled to receive up to an aggregate of $340.0 million in additional development milestones and up to an aggregate of $1.890 billion in contingent payments upon achievement of specified annual net sales amounts.

We are responsible for the manufacture and supply of fasinumab globally.

Within the United States, we will lead commercialization activities, and the parties will share equally in any profits or losses in connection with commercialization of fasinumab.

In the territory outside of the United States, Teva will lead commercialization activities and we will supply product to Teva at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances).

Odronextamab (REGN1979)

In 2020, we entered into an agreement with Zai Lab Limited to develop and commercialize odronextamab in mainland China, Hong Kong, Taiwan, and Macau (the "Zai Territories").

In connection with the agreement, Zai made a $30.0 million non-refundable up-front payment to the Company.

We continue to lead global development activities for odronextamab, and Zai is responsible for funding a portion of the global development costs for certain clinical trials.

We are responsible for the manufacture and supply of clinical and commercial product of odronextamab to Zai.

If odronextamab is commercialized in the Zai Territories, we will supply the product to Zai at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and we are eligible to receive up to $160.0 million in additional regulatory and sales milestone payments.

We and Teva are parties to a collaboration agreement to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with MTPC.

In connection with the agreement, Teva made a $250.0 million non-refundable up-front payment in 2016.

We led global development activities, including the manufacturing of fasinumab, and the parties shared development costs equally.

As of December 31, 2022, we had received an aggregate $120.0 million of development milestones from Teva.

During the third quarter of 2022, we discontinued further clinical development of fasinumab.

In 2018, we and Alnylam Pharmaceuticals, Inc.

entered into a collaboration to discover RNA interference ("RNAi") therapeutics for NASH and potentially other related diseases, as well as to research, co-develop and commercialize any therapeutic product candidates that emerge from these discovery efforts (including ALN-HSD, which is currently in clinical development).

ALN-HSD is being co-developed with Alnylam with terms generally consistent with the form of a Co-Commercialization Collaboration Agreement in connection with the 2019 collaboration agreement as described below.

Alnylam is conducting the Phase 1 clinical trial for ALN-HSD and Regeneron will be the lead party for all future development.

Under the terms of the collaboration agreement, the parties share development costs equally.

During the fourth quarter of 2022, Alnylam elected to opt-out of further development activities related to ALN-HSD;

as a result, we retain the exclusive right to develop and commercialize such product and Alnylam will receive a royalty on sales (if any).

In 2019, we and Alnylam entered into a global, strategic collaboration to discover, develop, and commercialize RNAi therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system ("CNS"), in addition to a select number of targets expressed in the liver.

Under the terms of the agreement, we made an up-front payment of $400.0 million to Alnylam.

For each program, we will provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $200.0 million in clinical proof-of-principle milestones for eye and CNS programs.

In connection with the collaboration, the Company made an up-front payment of $400.0 million to Alnylam, and also purchased shares of Alnylam common stock for $400.0 million.

For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation, and Alnylam is eligible to receive up to an aggregate of $200.0 million in clinical proof-of-principle milestones for eye and CNS programs.

Under the collaboration, the parties plan to perform discovery research until designation of lead candidates.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a License Agreement or a Co-Commercialization Collaboration Agreement structure.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-development/co-commercialization collaboration agreement ("Co-Co Collaboration Agreement") (under which the parties are advancing ALN-APP and ALN-PNP, which are currently in clinical development) or a License Agreement structure.

The initial target nomination and discovery period is five years (which may under certain situations automatically be extended for up to seven years in the aggregate) (the "Research Term").

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At the stage of designation of a lead candidate for eye programs, we have the sole right to take the product forward as a licensee.

The lead party is required to take the program forward under the License Agreement structure unless the other party exercises its rights to opt-in to a Co-Commercialization Collaboration Agreement, in which case the lead party is required to take the program forward under the Co-Commercialization Collaboration Agreement structure.

Alnylam does not have rights to opt-in to a Co-Commercialization Collaboration Agreement for eye programs.

The lead party is required to take the program forward under the License Agreement structure unless the other party exercises its rights to opt-in to a Co-Co Collaboration Agreement as a participating party, in which case the lead party is required to take the program forward under the Co-Co Collaboration Agreement structure.

Alnylam does not have rights to opt-in to a Co-Co Collaboration Agreement for eye programs.

Under a License Agreement, the lead party is designated as the licensee and has the right to develop and commercialize the collaboration product under such program.

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The licensee will pay to the licensor certain development and/or commercialization milestone payments, as well as certain tiered royalty payments to the licensor based on the aggregate annual net sales of the collaboration product.

For CNS programs and liver programs, as soon as a party is designated as a lead party, the other company has rights to opt-in to a Co-Commercialization Collaboration Agreement as a participating party.

Under a Co-Commercialization Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.

For CNS programs and liver programs, under a Co-Co Collaboration Agreement, the party designated as the lead party will lead development and commercialization of the program and the parties will split profits and share costs equally, subject to certain co-funding opt-outs at specified clinical trial phases or under other conditions.

If a party exercises its co-funding opt-out right, the lead party will be required to make certain tiered royalty payments to the other party based on the aggregate annual net sales of the collaboration product and the timing of the exercise of the co-funding opt-out right.

If the non-lead party does not initially opt-in to a Co-Commercialization Collaboration Agreement, the lead party has the right to take the program forward under a License Agreement structure.

Under the collaboration, when we are the licensee under a License Agreement or the lead party under a Co-Commercialization Collaboration Agreement, Alnylam will be responsible for the manufacture and supply of the product to us for Phase 1 and Phase 2 clinical trials.

In connection with the collaboration, we also purchased shares of Alnylam common stock for aggregate cash consideration of $400.0 million.

In 2019, the parties entered into a Co-Commercialization Collaboration Agreement for an siRNA therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination product consisting of cemdisiran and pozelimab, with us as the licensee.

Under the C5 siRNA Co-Commercialization Collaboration agreement, the parties share costs equally and will split profits (if commercialized);

and under the License Agreement, the licensee is responsible for its own costs and expenses.

The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on our potential future net sales of the combination product only subject to customary reductions, as well as up to $325.0 million in sales milestones.

Under the collaboration, when we are the licensee under a License Agreement or the lead party under a Co-Co Collaboration Agreement, Alnylam will be responsible for the manufacture and supply of the product to us for Phase 1 and Phase 2 clinical trials.

In addition, during 2019, the parties entered into a Co-Co Collaboration Agreement for cemdisiran, an siRNA therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam, with Alnylam as the lead party, and a License Agreement for a combination consisting of cemdisiran and pozelimab, with us as the licensee.

Under the C5 siRNA Co-Co Collaboration Agreement, the parties shared costs equally, and under the License Agreement, we as the licensee are responsible for our own costs and expenses.

The C5 siRNA License Agreement contains a flat low double-digit royalty payable to Alnylam on potential future net sales of the combination only subject to customary reductions, as well as up to $325.0 million in sales milestones.

During the fourth quarter of 2022, we elected to opt-out of further development activities pursuant to the Co-Co Collaboration Agreement for cemdisiran as a monotherapy;

as a result, Alnylam retains the right to develop and commercialize such product and we will receive a royalty on sales (if any).

In 2016, we entered into a license and collaboration agreement with Intellia Therapeutics, Inc.

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NTLA-2001, which is in clinical development, is subject to a co-development and co-commercialization arrangement pursuant to which Intellia will lead development and commercialization activities and the parties share an agreed-upon percentage of development expenses and profits (if commercialized).

In May 2020, we expanded our existing collaboration with Intellia Therapeutics, Inc.

to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

In 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the companies to jointly develop potential products for the treatment of hemophilia A and B, with Regeneron leading development and commercialization activities.

In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products.

In connection with the May 2020 agreement, we made a $70.0 million up-front payment and purchased shares of Intellia common stock for an aggregate purchase price of $30.0 million.

In connection with the 2020 agreement, we made a $70.0 million up-front payment to Intellia.

We and BARDA are parties to agreements pursuant to which HHS provided certain funding to develop, test, and manufacture a treatment for Ebola virus infection.

In July 2020, HHS exercised its option under an existing agreement to provide up to $344.6 million of additional funding for the manufacture and supply of Inmazeb.

In 2020, HHS exercised its option under an existing agreement to provide additional funding for the manufacture and supply of Inmazeb.

We expect to deliver a pre-specified number of Inmazeb treatment doses over the course of approximately six years.

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Government" section above for information related to our COVID-19 agreements.

As described under "Products" above, pursuant to a 2017 license agreement, we granted Kiniksa Pharmaceuticals, Ltd.

Pursuant to a 2017 license agreement, we granted Kiniksa Pharmaceuticals, Ltd.

the right to develop and commercialize certain new indications for ARCALYST.

During the first quarter of 2021, Kiniksa received marketing approval in the United States for a new indication of ARCALYST, recurrent pericarditis, and, as a result, we received a $20.0 million milestone payment from Kiniksa.

During the first quarter of 2021, Kiniksa received marketing approval in the United States for a new indication of ARCALYST, recurrent pericarditis.

The quarterly period ended March 31, 2021 was the last quarter for which the Company recorded net product sales of ARCALYST.

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Kiniksa will pay Regeneron 50% of its profits from sales of ARCALYST and the parties will not share in any losses incurred by Kiniksa in connection with commercialization of ARCALYST.

As described under "Products" above, in January 2022 we entered into a license and collaboration agreement for Ultragenyx Pharmaceutical Inc.

In January 2022, we entered into a license and collaboration agreement for Ultragenyx Pharmaceutical Inc.

to develop and commercialize Evkeeza in countries outside of the United States.

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We will supply commercial product to Ultragenyx at a tiered purchase price, which is calculated as a percentage of net sales of the product (subject to adjustment in certain circumstances), and are eligible to receive additional regulatory and sales milestone payments.

We have also granted Ultragenyx an exclusive option to negotiate a separate agreement to collaborate on the development and commercialization of garetosmab outside of the United States under terms to be agreed upon by both companies.

In May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc.

for a total equity value of approximately $250 million.

In connection with the acquisition, the Company obtained the rights to vidutolimod, which is in clinical development for oncology.

Manufacturing

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These facilities consist of owned and leased research, manufacturing, office, laboratory, and warehouse space.

In addition, during 2022, we expect to continue the construction of a fill/finish facility in Rensselaer, New York.

We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility, and are approved by the FDA and other regulatory agencies to manufacture our bulk drug materials and products.

In addition, we currently have approximately 130,000 liters of cell culture capacity at our Limerick facility which has received certain manufacturing approvals by regulatory agencies, including the FDA.

In addition, the construction of a fill/finish facility in Rensselaer, New York is in process.

We currently have approximately 100,000 liters of cell culture capacity at our Rensselaer facility and approximately 120,000 liters of cell culture capacity at our Limerick facility.

Each of these facilities is approved by the FDA and certain other regulatory agencies to manufacture our bulk drug materials and products.

Certain bulk drug materials and products are also manufactured by our collaborators, and certain raw materials or products necessary for the manufacture and formulation of our products and product candidates are provided by single-source unaffiliated third-party suppliers.

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Manufacturing establishments, both foreign and domestic, are also subject to inspections by or under the authority of the FDA and by other national, federal, state, and local agencies.

Our medicines are marketed through our commercial group, which includes experienced professionals in the fields of marketing, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, market research, and forecasting.

We sell our marketed products in the United States primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers.

Our medicines are marketed through our commercial group, which includes experienced professionals in the fields of marketing, sales, professional education, patient education, reimbursement and market access, trade and distribution, commercial operations, commercial analytics, and market research.

In the United States, we sell our marketed products primarily to wholesalers and specialty distributors that serve pharmacies, hospitals, government agencies, physicians, and other healthcare providers.

We had sales to two customers (Besse Medical, a subsidiary of AmerisourceBergen Corporation, and McKesson Corporation) that each accounted for more than 10% of total gross product revenue for the year ended December 31, 2022.

On a combined basis, our product sales to these customers accounted for 83% of our total gross product revenue for the year ended December 31, 2022.

We promote approved medicines to healthcare professionals via our team of U.S.-based field employees, as well as medical journals, medical exhibitions, distribution of literature and samples, and online channels.

In addition, we advertise certain products directly to U.S.

consumers and maintain websites with information about our medicines.

We promote approved medicines to healthcare professionals via our team of field employees, as well as medical journals, medical exhibitions, distribution of literature and samples, and online channels.

In addition, we advertise certain products directly to consumers and maintain websites with information about our medicines.

The commercial group also evaluates opportunities for our targets and product candidates and prepares for market launches of new medicines.

Additionally, we are a party to several collaboration agreements, whereby our collaborator is responsible for recording product sales of certain products either solely outside the United States or globally.

We have exercised our option to co-commercialize some products in accordance with such collaboration agreements.

Refer to "Collaboration, License, and Other Agreements" section above for additional information.

We have established certain commercial capabilities outside the United States in connection with co-commercializing some products in accordance with our collaboration agreements.

In addition, we are in process of building additional commercial capabilities outside the United States as a result of us obtaining the rights, in 2022, to commercialize Libtayo outside the United States.

Refer to "Collaboration, License, and Other Agreements" section above for additional information related to these agreements.

We face substantial competition from pharmaceutical, biotechnology, and chemical companies.

Our ability to compete depends, to a great extent, on how fast we can develop safe and effective product candidates, complete clinical testing and approval processes, and supply commercial quantities of the product to the market.

Competition among products approved for sale is based on efficacy, safety, reliability, availability, price, patent position, and other factors.

Competition among products approved for sale is based on efficacy, safety, reliability, availability, price, patent and other intellectual property position, and other factors.

Marketed Products

The table below provides an overview of the current competitive landscape for the key products marketed by us and/or our collaborators under our collaboration agreements with them in such products' currently approved indications.

The table below provides an overview of the current competitive landscape for the key products marketed by us and/or our collaborators in such products' currently approved indications.

The table below is provided for illustrative purposes only and is not exhaustive.

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"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - The commercial success of our products and product candidates is subject to significant competition.

Marketed Product Competitor Product Competitor Indication Territory (1)

Marketed Product Competitor Product Competitor Indication Territory (a)

EYLEA Lucentis ® (ranibizumab injection)

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Byooviz ™ (ranibizumab-nuna) (biosimilar referencing Lucentis)

Samsung Bioepis Co., Ltd./Biogen Inc.

Samsung Bioepis Co., Ltd.

and Biogen Inc.

Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and mCNV United States, EU

Ximluci ® (ranibizumab) (biosimilar referencing Lucentis)

Xbrane Biopharma AB, Bausch + Lomb, and STADA Arzneimittel AG Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and CNV EU

Cimerli ™ (ranibizumab-eqrn) (biosimilar referencing Lucentis)

Formycon AG, Bioeq AG, Coherus BioSciences, Inc., and Teva Ltd.

Wet AMD, DME, macular edema following RVO (including CRVO and BRVO), diabetic retinopathy, and CNV United States, EU

Susvimo ® (ranibizumab ocular implant)

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Vabysmo ™ (faricimab-svoa)

Genentech/Roche Wet AMD, DME United States

Genentech/Roche Wet AMD, DME Worldwide

Avastin ® (bevacizumab) (off-label and repackaged)

Genentech/Roche Wet AMD, DME, and macular edema following RVO Worldwide

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Beovu ® (brolucizumab) Injection

Novartis Wet AMD Worldwide

Novartis AG Wet AMD, DME Worldwide

Ozurdex ® (dexamethasone intravitreal implant)

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DME, RVO United States, EU

Marketed Product (continued)

Competitor Product Competitor Indication Territory (a)

EYLEA (continued)

Iluvien ® (fluocinolone acetonide intravitreal implant)

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Mild-to-moderate atopic dermatitis United States, EU

Opzelura ® (ruxolitinib)

Incyte Corporation Mild-to-moderate atopic dermatitis United States

Olumiant ® (baricitinib)

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LEO Pharma Inc.

Moderate-to-severe atopic dermatitis United States, EU

Moderate-to-severe atopic dermatitis Worldwide

Corectim ® (delgocitinib)

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Atopic dermatitis Japan

Mitchga ® (nemolizumab)

Maruho Co., Ltd./Chugai Pharmaceutical Co., Ltd.

Pruritus associated with atopic dermatitis Japan

Xolair ® (omalizumab)

9 unchanged sentences

Tezspire ™ (tezepelumab-ekko)

AstraZeneca/Amgen Asthma United States

AstraZeneca/Amgen Asthma Worldwide

Libtayo Keytruda ® (pembrolizumab)

12 unchanged sentences

Praluent Repatha ® (evolocumab)

Amgen (1) Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease, (2) primary hyperlipidemia, and (3) HoFH Worldwide

Amgen Reduce the risk of myocardial infarction, stroke, and coronary revascularization in adults with established cardiovascular disease;

primary hyperlipidemia;

and HoFH Worldwide

Marketed Product (continued)

Competitor Product Competitor Indication Territory (1)

Competitor Product Competitor Indication Territory (a)

Praluent ( continued)

Leqvio ® (inclisiran)

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Rheumatoid arthritis EU, Japan

(1) This table focuses primarily on the United States, EU, and Japan.

(a) This table focuses primarily on the United States, EU, and Japan.

"Worldwide" indicates that the relevant product is approved in the United States, EU, Japan, and at least one other country.

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Our patent portfolio also includes issued patents and pending applications relating to commercialized products and our product candidates in clinical development.

These patents cover the proteins and DNA encoding the proteins, manufacturing patents, method of use patents, and pharmaceutical compositions.

These patents cover, among other things, proteins, DNA and RNA molecules, manufacturing patents, method of use patents, and pharmaceutical compositions and formulations.

The following table describes our U.S.

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US 10,888,601 Methods of Treatment January 11, 2032

US 11,253,572 Methods of Treatment January 11, 2032

US 10,406,226 Method of Manufacturing March 22, 2026

7 unchanged sentences

February 27, 2028 – October 1, 2029 (d)

dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e)

US 8,945,559 Formulation October 17, 2032

Product (continued)

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General Subject Matter Class Expiration

Dupixent (a) (continued)

Dupixent dupilumab US 7,608,693 Composition of Matter March 28, 2031 (e)

US 8,945,559 Formulation October 17, 2032

US 9,238,692 Formulation October 5, 2031

US 10,435,473 Formulation October 5, 2031

US 11,059,896 Formulation October 5, 2031

US 8,075,887 Methods of Treatment April 17, 2028

2 unchanged sentences

US 9,574,004 Methods of Treatment December 22, 2033

US 11,421,036 Methods of Treatment July 10, 2034

US 10,137,193 Methods of Treatment March 18, 2036

US 10,485,844 Methods of Treatment September 21, 2037

US 10,059,771 Methods of Treatment June 20, 2034

US 11,214,621 Methods of Treatment March 11, 2036

US 11,167,004 Methods of Treatment September 21, 2037

US 11,034,768 Methods of Treatment March 23, 2039

US 11,292,847 Methods of Treatment May 10, 2039

EP 2356151 Composition of Matter October 27, 2029 (c)

5 unchanged sentences

EP 3470432 Methods of Treatment August 20, 2033

EP 3019191 Methods of Treatment July 10, 2034

EP 2624865 Formulation October 5, 2031

9 unchanged sentences

Methods of Treatment

June 20, 2034

June 20, 2034 – September 2, 2035 (d)

Methods of Treatment

November 13, 2035

JP 7,164,530 Methods of Treatment September 21, 2037

Libtayo cemiplimab US 9,987,500 Composition of Matter September 18, 2035

1 unchanged sentence

US 10,457,725 Methods of Treatment May 12, 2037

US 11,292,842 Methods of Treatment July 18, 2038

US 11,505,600 Methods of Treatment July 2, 2038

EP 3097119 Composition of Matter January 23, 2035

EP 3455258 Methods of Treatment May 12, 2037

EP 3932951 Methods of Treatment May 12, 2037

Composition of Matter January 23, 2035

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Libtayo (continued)

JP 6,999,577 Methods of Treatment May 12, 2037

JP 7,054,680 Methods of Treatment May 12, 2037

Praluent (a)(f)

5 unchanged sentences

US 9,724,411 Methods of Treatment January 15, 2031

US 11,246,925 Methods of Treatment April 11, 2032

US 11,306,155 Methods of Treatment July 16, 2035

US 10,428,157 Methods of Treatment December 26, 2037

3 unchanged sentences

EP 2358756 Composition of Matter December 15, 2029 (c)

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Praluent (a)(f)

EP 2358756 (Supplementary Protection Certificate) (September 25, 2030) (c)

2 unchanged sentences

EP 3055333 Methods of Treatment October 10, 2034

EP 3689913 Methods of Treatment October 10, 2034

EP 3169353 Methods of Treatment July 16, 2035

15 unchanged sentences

EP 3409269 Formulation January 7, 2031

EP 3756652 Formulation January 7, 2031

Composition of Matter June 1, 2027 – August 22, 2031 (d)

2 unchanged sentences

October 10, 2032 – March 29, 2033 (d)

JP 7,025,477 Methods of Treatment October 10, 2032

Product (continued)

Molecule Territory Patent No.

General Subject Matter Class Expiration

Kevzara (continued)

Methods of Treatment November 21, 2034

REGEN-COV (a)

casirivimab and imdevimab US 10,787,501 Composition of Matter June 25, 2040

US 10,975,139 Composition of Matter June 25, 2040

JP 7,166,925 Methods of Treatment March 7, 2037

(a) See Note 16 to our Consolidated Financial Statements for information regarding inter partes review and post-grant review petitions filed in the U.S.

Patent and Trademark Office relating to EYLEA and patent infringement proceedings relating to Dupixent, Praluent, and REGEN-COV.

Patent and Trademark Office relating to EYLEA and patent infringement proceedings relating to Praluent.

(b) A patent term extension has been granted by the U.S.

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"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - Loss or limitation of patent rights, and regulatory pathways for biosimilar competition, could reduce the duration of market exclusivity for our products ").

For example, in the United States, the regulatory exclusivity period for EYLEA (i.e., the period during which no biosimilar product can be approved by the FDA) extends through May 17, 2024 following the pediatric exclusivity granted by the FDA.

The effect of expiration of a patent relating to a particular product also depends upon other factors, such as the nature of the market and the position of the product in it, the growth of the market, the complexities and economics of the process for manufacture of the active ingredient of the product, and the requirements of new drug provisions of the Federal Food, Drug and Cosmetic Act or similar laws and regulations in other countries.

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to obtain a license under certain patents owned and/or exclusively licensed by one or more of these parties that includes the right to develop and sell Libtayo.

Under the agreement, we and Sanofi pay royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5% from January 1, 2024 through December 31, 2026.

The royalties are shared equally by us and Sanofi.

Under the agreement, we pay royalties of 8.0% on worldwide sales of Libtayo through December 31, 2023, and royalties of 2.5% from January 1, 2024 through December 31, 2026.

Patent law relating to the patentability and scope of claims in the biotechnology field is evolving and our patent rights are subject to this additional uncertainty.

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It is possible that patents issued or licensed to us will be successfully challenged, that a court may find that we are infringing validly issued patents of third parties, or that we may have to alter or discontinue the development of our products or pay licensing fees to take into account patent rights of third parties (see Part I, Item 1A.

"Risk Factors - Risks Related to Intellectual Property and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights ";

"Risk Factors - Risks Related to Intellectual Property

and Market Exclusivity - We may be restricted in our development, manufacturing, and/or commercialization activities by patents or other proprietary rights of others, and could be subject to awards of damages if we are found to have infringed such patents or rights ";

and Note 16 to our Consolidated Financial Statements).

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All of our product candidates require regulatory approval by relevant government authorities before they can be commercialized.

In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA and foreign authorities.

In particular, human therapeutic products are subject to rigorous preclinical and clinical trials and other pre-market approval requirements by the FDA, EMA, and other foreign regulatory authorities.

The structure and substance of the FDA and foreign pharmaceutical regulatory practices may evolve over time.

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Phase 3 data often form the core basis on which the FDA and comparable foreign regulatory authorities evaluate a product candidate's safety and effectiveness when considering the product application for regulatory approval.

If concerns arise about the safety of the product candidate, the FDA or other regulatory authorities can stop clinical trials by placing them on a "clinical hold" pending receipt of additional data, which can result in a delay or termination of a clinical development program.

The sponsoring company, the FDA or other regulatory authorities, or the IRB or Ethics Committee and competent authority may suspend or terminate a clinical trial at any time on various grounds, including a finding that the patients are being exposed to an unacceptable health risk.

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Although the FDA is not bound by the recommendation of an advisory committee, the agency considers such recommendations carefully when making decisions.

Before approving a new drug or biologic product, the FDA

also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

Before approving a new drug or biologic product, the FDA also requires that the facilities at which the product will be manufactured or advanced through the supply chain be in compliance with current Good Manufacturing Practices, or cGMP, requirements and regulations governing, among other things, the manufacture, shipment, and storage of the product.

The FDA also can audit the sponsor of the BLA to determine if the clinical studies were conducted in compliance with current GCPs.

After review of a BLA, the FDA may grant marketing approval, request additional information, or issue a complete response letter ("CRL") outlining the deficiencies in the submission.

After review of a BLA, the FDA may grant marketing approval, request additional information, or issue a CRL outlining the deficiencies in the submission.

The CRL may require additional testing or information, including additional preclinical or clinical data, for the FDA to reconsider the application.

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In some EU countries, we may also be required to have an approved PIP before we can begin enrolling pediatric patients in a clinical trial.

In the United States, under the Pediatric Research Equity Act ("PREA"), certain applications for approval must include an assessment, generally based on clinical study data, of the safety and effectiveness of the subject product in relevant pediatric populations, unless a waiver or deferral is granted.

deferral is granted.

However, a pediatric study plan is not required for orphan products and the timing of the submission is subject to negotiation with FDA, but such plan cannot be submitted later than submission of a BLA.

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The Secretary of HHS may authorize unapproved medical products to be marketed in the context of an actual or potential emergency that has been designated by the U.S.

The COVID-19 pandemic has been designated as such a national emergency.

The COVID-19 pandemic has been designated as such a national emergency, with such designation currently expected to expire on May 11, 2023.

After an emergency has been announced, the Secretary of HHS may authorize the issuance of, and the FDA Commissioner may issue, EUAs for the use of specific products based on criteria established by the Food, Drug, and Cosmetic Act, including that the product at issue may be effective in diagnosing, treating, or preventing serious or life-threatening diseases when there are no adequate, approved, and available alternatives.

Although the criteria of an EUA differ from the criteria for approval of a BLA, EUAs nevertheless require the development and submission of data to satisfy the relevant FDA standards, as well as a number of ongoing compliance obligations.

The FDA expects EUA holders to work toward submission of full

applications, such as a BLA, as soon as possible.

The FDA expects EUA holders to work toward submission of full applications, such as a BLA, as soon as possible.

An EUA is also subject to additional conditions and restrictions and is product-specific.

13 unchanged sentences

See Part I, Item 1A.

"Risk Factors - Other Regulatory and Litigation Risks - Our business activities have been, and may in the future be, challenged under federal or state healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties ."

"Risk Factors - Other Regulatory and Litigation Risks - Our business activities have been, and may in the future be, challenged under U.S.

federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties ."

Adverse-event reporting and submission of periodic reports are required following marketing approval.

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The EC may, in particular, impose a PASS and/or PAES on marketing authorization holders when a marketing authorization is granted upon conditions.

The EC may grant conditional marketing

authorizations in the interest of public health, when there is less comprehensive clinical data available than would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.

The EC may grant conditional marketing authorizations in the interest of public health, when there is less comprehensive clinical data available than would be required, if the EC considers that the benefit of immediate availability may outweigh the risk that the absence of the required clinical data poses.

In addition, we and our third-party suppliers are required to maintain compliance with cGMP, and are subject to inspections by the FDA or comparable regulatory authorities in other jurisdictions to confirm such compliance.

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We participate in, and have certain price reporting obligations to, the Medicaid Drug Rebate program, state Medicaid supplemental rebate program(s), and other governmental pricing programs.

We also have obligations to report the average sales price for certain drugs to the Medicare program as part of our agreement to participate in the Medicaid Drug Rebate program.

For calendar quarters beginning January 1, 2022, we will be required to report the average sales price for certain drugs under the Medicare program regardless of whether we participate in the Medicaid Drug Rebate Program.

Under the Medicaid Drug Rebate program, we are required to pay a rebate to each state Medicaid program for our covered outpatient drugs that are dispensed to Medicaid beneficiaries and paid for by a state Medicaid program as a condition of having federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

We also have obligations to report the average sales price for certain drugs to the Medicare program.

Medicaid program as a condition of having federal funds being made available for our drugs under Medicaid and Part B of the Medicare program.

Medicaid is a joint federal and state program that is administered by the states for low-income and disabled beneficiaries.

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The federal Patient Protection and Affordable Care Act (the "PPACA") made significant changes to the Medicaid Drug Rebate program, and CMS issued a final regulation, which became effective on April 1, 2016, to implement the changes to the Medicaid Drug Rebate program under the PPACA.

On December 21, 2020, CMS issued a final rule that modified Medicaid Drug Rebate program regulations to permit reporting multiple best price figures with regard to value‑based purchasing arrangements (beginning in 2022);

provide definitions for "line extension," "new formulation," and related terms with the practical effect of expanding the scope of drugs considered to be line extensions (beginning in 2022);

and revise best price and average manufacturer price exclusions of manufacturer-sponsored patient benefit programs, particularly regarding potential inapplicability of such exclusions in the context of pharmacy benefit manager "accumulator" programs (beginning in 2023).

CMS recently modified Medicaid Drug Rebate program regulations to, among other things, permit reporting multiple best price figures with regard to value‑based purchasing arrangements and provide definitions for "line extension," "new formulation," and related terms with the practical effect of expanding the scope of drugs considered to be line extensions (beginning in 2022).

Medicare is a federal program that is administered by the federal government that covers individuals age 65 and over or that are disabled as well as those with certain health conditions.

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Manufacturers, including us, are required to report average sales price information to CMS on a quarterly basis.

The manufacturer-submitted information is used by CMS to calculate Medicare payment rates.

The manufacturer-submitted information may be used by CMS to calculate Medicare payment rates.

Starting in 2023, manufacturers must pay refunds to Medicare for single-source drugs or biological products, or biosimilar biological products, reimbursed under Medicare Part B and packaged in single-dose containers or single-use packages for units of discarded drug reimbursed by Medicare Part B in excess of 10 percent of total allowed charges under Medicare Part B for that drug.

Manufacturers that fail to pay refunds could be subject to civil monetary penalties of 125 percent of the refund amount.

Manufacturers that fail to pay refunds could be subject to civil monetary penalties.

Further, starting in 2023, the Inflation Reduction Act ("IRA") establishes a Medicare Part B inflation rebate scheme under which, generally speaking, manufacturers will owe rebates if the average sales price of a Part B drug increases faster than the pace of inflation.

Failure to timely pay a Part B inflation rebate is subject to a civil monetary penalty.

The IRA also creates a drug price negotiation program under which, after being on the market for a certain period of time, the prices for certain high Medicare spending drugs and biological products provided to Medicare patients without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price, starting in 2026.

Failure to comply with requirements under the drug price negotiation program is subject to an excise tax and a civil monetary penalty.

This or any other legislative change could impact the market conditions for our products.

See Part I, Item 1A.

"Risk Factors - Risks Related to Commercialization of Our Marketed Products, Product Candidates, and New Indications for Our Marketed Products - Sales of our marketed products are dependent on the availability and extent of reimbursement from third-party payors, and changes to such reimbursement may materially harm our business, prospects, operating results, and financial condition.

Civil monetary penalties can be applied if we are found to have knowingly submitted any false pricing or other information to the government, if we are found to have made a misrepresentation in the reporting of our average sales price, or if we fail to submit the required data on a timely basis.

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Covered entities include hospitals that serve a disproportionate share of financially needy patients, community health clinics, and other entities that receive certain types of grants under the Public Health Service Act.

The PPACA expanded the list of covered entities to include certain free-standing cancer hospitals, critical access hospitals, rural referral centers, and sole community hospitals, but exempts "orphan drugs" from the ceiling price requirements for these covered entities.

the ceiling price requirements for these covered entities.

The 340B ceiling price is calculated using a statutory formula, which is based on the average manufacturer price and Medicaid rebate amount for the covered outpatient drug as calculated under the Medicaid Drug Rebate program.

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An ADR proceeding could subject us to onerous procedural requirements and could result in additional liability.

On November 30, 2022, HRSA issued a notice of proposed rulemaking that proposes several changes to the ADR process.

HRSA also implemented a price reporting system under which we are required to report our 340B ceiling prices to HRSA on a quarterly basis, which then publishes those prices to 340B covered entities.

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The prescription drug plans negotiate pricing with manufacturers and pharmacies, and may condition formulary placement on the availability of manufacturer discounts.

In addition, for 2021, manufacturers, including us, are required to provide to CMS a 70% discount on brand name

prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

In addition, manufacturers, including us, are required to provide to CMS a 70% discount on brand name prescription drugs utilized by Medicare Part D beneficiaries when those beneficiaries are in the coverage gap phase of the Part D benefit design.

The IRA includes a sunset provision with respect to the coverage gap discount program starting in 2025 and replaces it with a new manufacturer discount program.

In addition, as of October 2022, the IRA established a Medicare Part D inflation rebate scheme under which, generally speaking, manufacturers will owe additional rebates if the average manufacturer price of a Part D drug increases faster than the pace of inflation.

Failure to timely pay a Part D inflation rebate is subject to a civil monetary penalty.

Private payor healthcare and insurance providers, health maintenance organizations, and pharmacy benefit managers in the United States are adopting more aggressive utilization management techniques and are increasingly requiring significant discounts and rebates from manufacturers as a condition to including products on formulary with favorable coverage and copayment/coinsurance.

10 unchanged sentences

See Part I, Item 1A.

"Risk Factors - Other Regulatory and Litigation Risks - Our business activities have been, and may in the future be, challenged under U.S.

federal or state and foreign healthcare laws, which may subject us to civil or criminal proceedings, investigations, or penalties ."

We are subject to the Foreign Corrupt Practices Act, or FCPA, and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which we operate, including the U.K.

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In the United States, there are numerous federal and state laws and regulations governing data privacy of personal data and the collection, use, disclosure, and protection of health data, genetic data, consumer data, and children's data.

Such laws and regulations include the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, "HIPAA"), as well as state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (such as Section 5 of the Federal Trade Commission Act and the California Consumer Privacy Act (the "CCPA")).

Such laws and regulations include the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, "HIPAA"), as well as state data breach notification laws, state health information and/or genetic privacy laws, and federal and state consumer protection laws (such as Section 5 of the Federal Trade Commission Act (the "FTC Act") and the California Consumer Privacy Act (the "CCPA")).

Many of these laws differ from each other in significant ways and have different effects.

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Most health care providers, including research institutions from which we or our collaborators obtain clinical trial data, are subject to HIPAA.

Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive, use, or disclose PHI maintained by a HIPAA-covered entity in a manner that is not permitted under HIPAA.

Although we are not directly subject to HIPAA other than with respect to providing certain employee benefits, we could potentially be subject to criminal penalties if we, our affiliates, or our agents knowingly receive PHI maintained by a HIPAA-covered entity in a manner that is not permitted under HIPAA.

The Federal Trade Commission ("FTC") also sets expectations for failing to take appropriate steps to keep consumers' personal information secure, or failing to provide a level of security commensurate to promises made to individuals about the security of their personal information (such as in a privacy notice) may constitute unfair or deceptive acts or practices in violation of Section 5 of the FTC Act.

The FTC expects a company's data security measures to be reasonable and appropriate in light of the sensitivity and volume of consumer information it holds, the size and complexity of its business, and the cost of available tools to improve security and reduce vulnerabilities.

Individually identifiable health information is considered sensitive data that merit stronger safeguards.

With respect to privacy, the FTC also sets expectations that companies honor the privacy promises made to individuals about how the company handles consumers' personal information;

and any failure to honor promises, such as the statements made in a privacy policy or on a website, may also constitute unfair or deceptive acts or practices in violation of the FTC Act.

The FTC has the power to enforce promises as it interprets them, and events that we cannot fully control, such as data breaches, may result in FTC enforcement.

Enforcement by the FTC under the FTC Act can result in civil penalties or enforcement actions.

To the extent we collect California resident personal data, we are also subject to the CCPA.

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The amendments introduced by the CPRA go into effect on January 1, 2023, and new implementing regulations are expected to be introduced by the CPPA.

Failure to comply with the CCPA

may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with certain types of incidents.

Failure to comply with the CCPA may result in, among other things, significant civil penalties and injunctive relief, or statutory or actual damages.

In addition, California residents have the right to bring a private right of action in connection with data privacy incidents involving certain elements of personal data.

These claims may result in significant liability and damages.

Similarly, there are a number of legislative proposals in the United States, at both the federal and state level, that could impose new obligations or limitations in the area of consumer protection.

Similarly, there are a number of legislative proposals in the United States, at both the federal and state level, that could impose new obligations or limitations in

the area of consumer protection.

For example, states such as Virginia, Colorado, and Utah have enacted similar privacy laws that impose new obligations or limitations in areas affecting our business, and efforts at the federal level to enact similar laws have been ongoing.

We may be subject to fines, penalties, or private actions in the event of non-compliance with such laws.

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With respect to the transfer of personal data outside of the EU, while there are legal mechanisms available to lawfully transfer personal data outside of the EU, including to the United States, there are certain unsettled legal issues regarding such data transfers, the resolution of which may adversely affect our ability to transfer personal data or otherwise may cause us to incur significant costs to come into compliance with applicable data transfer impact assessments and implementation of legal data transfer mechanisms.

In June 2021, the European Commission published new standard contractual clauses required to be incorporated into new and existing agreements within prescribed timeframes in order to continue to lawfully transfer personal data outside of the EU.

In 2021, the European Commission published new standard contractual clauses required to be incorporated into new and existing agreements within prescribed timeframes in order to continue to lawfully transfer personal data outside of the EU.

Different EU member states, as well as the United Kingdom and Switzerland, have promulgated national privacy laws that impose additional requirements, which add to the complexity of processing and transferring EU personal data.

Some countries outside of the EU have reacted to the GDPR by promulgating and enacting new privacy legislation that reflects similar principals and obligations on companies that operate and process their citizens' personal data.

In October 2022, the United States issued an executive order to implement EU-U.S.

data privacy safeguards.

The European Commission is now expected to review the executive order and could propose an adequacy decision concerning the level of personal data protection in the United States under which personal data could flow freely from the EU to the United States.

Some countries outside of the EU have reacted to the GDPR by promulgating and enacting new privacy legislation that reflects similar principles and obligations on companies that operate and process their citizens' personal data.

Any failure or perceived failure to comply with privacy-related legal obligations, or any compromise of security of personal data, may result in governmental enforcement actions, litigation, contractual indemnity claims, or restraining orders that would impact our ability to process and share data globally.

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Attracting, developing, and retaining skilled and experienced employees in research and development, manufacturing, sales and marketing, and other positions is crucial to our ability to compete effectively.

Our ability to recruit and retain such employees depends on a number of factors, including our corporate culture and work environment, informed by our values and behaviors (which we call The Regeneron Way) and our corporate philosophy of "Doing Well by Doing Good";

talent development and career opportunities;

and compensation and benefits.

Integrity is a core value at Regeneron.

Both the Company and each of our employees have a responsibility to act ethically and with integrity at all times.

Our Code of Business Conduct and Ethics brings together Regeneron's key policy principles and establishes the Company's expectations for all of our employees to act in accordance with applicable laws, rules, and regulations.

Employee Profile

As of December 31, 2021, we had 10,368 full-time employees, consisting of 8,564 employed in the United States, 1,648 employed in Ireland, and 156 employed in other countries (including the United Kingdom, Germany, the Netherlands, and Canada).

Of these employees, 1,936 were within our research and preclinical development organization, 1,300 were within our global clinical development organization, and 5,037 were within our industrial operations and product supply organization.

As of December 31, 2022, we had 11,851 full-time employees, consisting of 9,843 employed in the United States, 1,721 employed in Ireland, and 287 employed in other countries (primarily in the United Kingdom and Germany).

Of these employees, 2,174 were within our research and preclinical development organization, 1,669 were within our global clinical development and

regulatory affairs organization, and 5,534 were within our industrial operations and product supply organization.

Company-wide, nearly 1,400 of our full-time employees hold a Ph.D.

We also supplement our workforce with independent contractors, contingent workers, and temporary workers, as needed.

None of our employees are represented by a labor union, and our management considers its relations with our employees to be good.

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Our employees represent a broad range of backgrounds, just like the people who take our medicines, and bring a wide array of perspectives and experiences that have helped us achieve our leadership position in the biotechnology and pharmaceuticals industries and the global marketplace.

A key component of our corporate culture is our commitment to the promotion of diversity, equity, and inclusion ("DEI").

A key component of our culture is our commitment to diversity, equity, and inclusion ("DEI").

We believe this commitment allows us to better drive innovation and achieve our mission to repeatedly bring important new medicines to patients with serious diseases.

Our DEI principles are reflected in our efforts in building a better workplace where employees can be themselves and succeed, advance medicine for all with better science, and use their voice and influence to create a better world.

We empower employee-led cross-functional resource groups ("ERGs") and interest groups, who connect around a common passion to build a culture of inclusion and collaborate to support under-served science and global communities.

In 2021, we launched several new ERGs, all of which align their objectives to our global DEI strategy and provide meaningful professional development opportunities for our workforce, with support from senior leaders as executive sponsors.

We empower employee-led cross-functional resource groups, functional/site-level DEI councils, and other interest groups, who connect around a common passion to build a culture of inclusion and collaborate to support under-served science and global communities.

In 2022, we introduced inclusive leadership education for some of our most senior leaders and launched a pilot mentorship program focused on our diverse talent base to increase visibility, connection, and the leadership skills of underrepresented talent.

While we are proud of our workforce diversity representation shown in the table below, we seek to continuously improve in this area.

In April 2020, we announced our 2025 global responsibility goals, including a commitment to increase diversity in leadership and foster inclusion.

Making progress toward this goal, in 2020, we established a DEI steering committee of senior leaders to provide oversight and guidance on our DEI efforts.

In 2021, we hired our Chief DEI Officer;

Making progress toward this goal, since then we hired our Chief DEI Officer;

launched a DEI strategy focused on creating a better workplace, better science, and better world;

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These councils are comprised of senior leaders who provide oversight and guidance on our DEI efforts and support the execution of our DEI strategy.

In order to better understand our employees' perspectives, we also conducted an employee engagement survey and launched an objective measure for inclusion and belonging.

Our board of directors received a detailed update on our DEI efforts in 2021 and continues to monitor our progress.

In order to better understand our employees' perspectives, we also measure inclusion and belonging as part of our annual employee engagement survey.

Our board of directors receives a detailed update on our DEI efforts at least once a year and continues to monitor our progress.

2022 Workforce Diversity Representation *

Female Representation (Global)

Minority Representation (U.S.

People of Color Representation (U.S.

* Based on full-time employees as of December 31, 2022

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Externally, we support DEI efforts in our community, including by supporting young scientific talent in underrepresented communities.

For example, through our partnership with the Society for Science, we contribute a substantial amount annually to science, technology, engineering, and mathematics ("STEM") equity and outreach programs to help increase access to science research education and bridge opportunity gaps among students historically underrepresented in the sciences.

For example, as part of our $100 million, 10-year commitment to support the Regeneron Science Talent Search, we allocate $3.1 million annually to fund the Society for Science’s science, technology, engineering, and math ("STEM") outreach and equity programs.

In 2022, we also continued our $24 million, 5-year title sponsorship of Regeneron International Science and Engineering Fair, with representation from over 1,700 student scientists representing 63 countries and 49 U.S.

In addition, we have developed a STEM pilot program with post-primary-school and high-school students in the New York State Capital Region and Limerick, Ireland that aspires to build long-term relationships with students from disadvantaged socio-economic groups, to encourage and support them in their studies, to inspire them to attend college, and, ultimately, to build a deeper more diverse talent pipeline.

We also continue to take steps to further integrate diversity considerations into the design and selection of sites for our clinical studies to make sure they reflect the diversity of patients with the diseases under investigation.

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We provide several programs related to employee health and wellness, including onsite amenities and programs such as meditation and prayer rooms and fitness centers.

Throughout the COVID-19 pandemic, we have continued to prioritize mental health initiatives and take further action to reduce or remove barriers to quality mental healthcare for our employees and their family members.

We also provide support for work-life balance through flex-time, remote working arrangements, child and elder care, and paid parental leave, among others.

We also prioritize mental health initiatives and have taken further action to reduce or remove barriers to quality mental healthcare for our employees and their family members.

In addition, we provide support for work-life balance through flex-time, remote working arrangements, child and elder care, and paid parental leave, among others.

Occupational health and safety is critical to our success.

We are committed to meeting or exceeding all environmental, health, safety ("EHS"), and security regulations and have a range of programs, plans, and procedures to ensure the safety of all people who come to work at Regeneron.

We are committed to meeting or exceeding all environmental, health, safety ("EHS") and security regulations and have a range of programs, plans, and procedures to ensure the safety of all people

who come to work at Regeneron.

In addition, our 2025 global responsibility goals include a commitment to focus on workplace injury prevention in our drive toward zero incidents.

In response to the COVID-19 pandemic, we implemented changes in our business beginning in March 2020 to protect our employees and support appropriate health and safety protocols, such as work-from-home policies for a significant portion of our employees, increased physical distancing in workspaces, and regular testing.

As the dynamics of the COVID-19 pandemic continue to evolve, we adjust and tailor our approach based on public health guidance and local community case rates.

For our essential employees who remain onsite in our laboratories and manufacturing facilities, we provide personal protective equipment

and require masks to be worn.

For any employee who contracts or is exposed to COVID-19, we provide full pay for their entire recovery and quarantine time.

In addition, we have established a workforce reintegration plan to facilitate our large-scale return to office.

The reintegration plan includes safety measures and procedures in compliance with local, state, and federal mandates.

Employee Growth and Development

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In addition, we continue to invest in our current and future leaders through a number of leadership development courses and programs and feedback and coaching opportunities.

In 2021, over 25% of job openings were filled by existing employees who were seeking career development opportunities.

In 2022, nearly 30% of job openings were filled by existing employees who were seeking career development opportunities.

Employee Engagement

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Employees are encouraged and empowered to support organizations and causes that are important to them including through, among other things, our matching gift program, volunteer-time-off policy, and our annual company-wide service event, Day for Doing Good .

In order to make progress on this goal during the COVID-19 pandemic, we transitioned volunteer programs to virtual formats to continue to support our non-profit partners while safeguarding health and safety.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 92.2% in 2021, as well as the fact that nearly 90% of our employees who responded to our annual engagement survey said Regeneron is a great place to work, of which we are especially proud since over 30% of our current workforce was onboarded during the COVID-19 pandemic.

Additionally, for the seventh consecutive year, we were recognized on the Fortune "100 Best Companies to Work For" list in 2021.

We have also placed in the top five for the past 11 years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry.

In 2022, nearly 7,000 employees volunteered approximately 31,200 hours, including approximately 55% of our employees who volunteered nearly 20,000 hours to approximately 190 nonprofits during our Day for Doing Good .

Additionally, through our Matching Gift Program, we matched over $2 million in employee contributions in 2022, supporting over 2,000 charities.

In 2022, we were named to the Civic 50 of most community-minded companies in the United States for the sixth consecutive year.

The success of our employee engagement efforts is demonstrated by our employee retention rate of 91% in 2022, as well as the fact that 87% of our employees who responded to our annual engagement survey said Regeneron is a great place to work.

Additionally, we have placed in the top five for the past 12 years in Science magazine’s annual "Top Employers Survey" of the global biotechnology and pharmaceutical industry.

Compensation and Benefits

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Our practice, therefore, has been to award initial equity grants to all new hires, in addition to our comprehensive annual equity program.

Total employee compensation packages (which varies by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of equity-based awards, comprehensive healthcare benefits, and retirement savings options and matching contributions.

Total employee compensation packages (which varies by country and region) include market-competitive pay (with the opportunity to receive above-market rewards), broad-based grants of equity-based awards, comprehensive healthcare benefits, parental leave, child and elder care support, retirement savings options, and matching contributions.

We annually review our workforce demographic and pay equity data to track our performance and inform new initiatives.

Our analysis indicates favorable performance in these areas, and we are committed to continued monitoring.

Corporate Information

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Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1. Business