What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2023-05-04 compared with 2022-11-03 · 217 added, 368 removed, 421 unchanged (58% of the section changed)

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Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.

These statements concern, and these risks and uncertainties include, among others, the impact of SARS-CoV-2 (the virus that has caused the COVID-19 pandemic) on Regeneron's business and its employees, collaborators, and suppliers and other third parties on which Regeneron relies, Regeneron's and its collaborators’ ability to continue to conduct research and clinical programs, Regeneron's ability to manage its supply chain, net product sales of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "Regeneron’s Products"), and the global economy;

the nature, timing, and possible success and therapeutic applications of Regeneron's Products and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, "Regeneron's Product Candidates") and research and clinical programs now underway or planned, including without limitation EYLEA ® (aflibercept) Injection, Dupixent ® (dupilumab) 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;

These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, "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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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;

the impact of public health outbreaks, epidemics, or pandemics (such as the COVID-19 pandemic) on our business;

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 11 to our Condensed 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 11 to our Condensed 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.

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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 medicines for preventing and treating human diseases.

Our objective is to continue to advance as 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:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2023 2022

17 unchanged sentences

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

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

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

Asthma (in adults and adolescents) a a a a

6 unchanged sentences

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

- Prurigo nodularis a a

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")

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Rheumatoid arthritis ("RA") a a a a

Polymyalgia rheumatica ("PMR")

Evkeeza (evinacumab) Injection (g)

HoFH (in adults and adolescents) a a a

HoFH (in pediatrics 5–11 years of age) a

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

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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.

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

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

Refer to "Additional Information - Clinical Development Programs" section below for further details regarding the status of the Emergency Use Authorization ("EUA") for REGEN-COV in the United States.

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

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

(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

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

Three Months Ended

September 30,

2023 2022 % Change

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$ 18.1 $ 16.5 $ 34.6 $ 9.9 $ 20.4 $ 30.3 14 %

Nine Months Ended

September 30,

2022 2021 % Change

(In millions) U.S.

ROW Total U.S.

ROW Total (Total Sales)

$ 4,768.2 $ 2,544.2 $ 7,312.4 $ 4,245.1 $ 2,567.7 * $ 6,812.8 7 %

$ 4,731.7 $ 1,500.6 $ 6,232.3 $ 3,364.8 $ 1,060.0 $ 4,424.8 41 %

$ 264.5 $ 144.7 $ 409.2 $ 225.5 $ 111.7 $ 337.2 21 %

$ 94.5 $ 239.5 $ 334.0 $ 130.0 $ 188.5 $ 318.5 5 %

REGEN-COV (e)

$ — $ 681.2 $ 681.2 $ 3,530.1 $ 1,173.2 $ 4,703.3 (86 %)

$ 153.1 $ 123.7 $ 276.8 $ 119.9 $ 113.7 $ 233.6 18 %

Other products (f)

$ 39.5 $ 54.1 $ 93.6 $ 15.2 $ 66.1 $ 81.3 15 %

* 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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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 "Products" section above and "Collaboration, License, and Other Agreements" section below for further details.

Included in this line item is approximately $17 million of net product sales recorded by Sanofi in the third quarter 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).

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

Included in this line item is approximately $6 million of net product sales recorded by Sanofi in the first quarter of 2023 in connection with sales in certain markets outside the United States (Sanofi records 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) Regeneron records net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays the Company a royalty on such sales.

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

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.

(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 "Results of Operations - Revenues " below for a complete listing of net product sales recorded by the Company.

In addition, not included in this line item are net product sales of ARCALYST subsequent to the first quarter of 2021, which are recorded by Kiniksa;

net product sales of ARCALYST were $27 million for the second quarter of 2022.

Not included in this line item are net product sales of ARCALYST, which are recorded by Kiniksa;

net product sales of ARCALYST were $40 million for the fourth quarter of 2022.

Programs in Clinical Development

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EYLEA (aflibercept) (a)

–ROP (U.S., EU)

–Every-16-weeks dosing regimen in patients with DR (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 Ministry of Health, Labour and Welfare ("MHLW") for ROP in Japan

–FDA decision on supplemental Biologics License Application ("sBLA") for ROP (target action date of February 11, 2023)

–FDA decision on sBLA for every-16-weeks dosing regimen in patients with DR (target action date of February 28, 2023)

–Approved by U.S.

Food and Drug Administration ("FDA") for ROP

Aflibercept 8 mg (a)

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

–Submit BLA for wet AMD and DME (fourth quarter 2022)

–Wet AMD and DME (U.S., EU, and Japan)

–FDA decision on BLA for wet AMD, DME, and DR (target action date of June 27, 2023)

–European Commission ("EC") and Ministry of Health, Labour and Welfare ("MHLW") decision on regulatory submissions for wet AMD and DME (first half 2024)

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

Immunology & Inflammation

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Antibody to IL-4R alpha subunit

–Grass allergy –EoE in pediatrics (c)

–Ulcerative colitis

–Eosinophilic gastroenteritis (Phase 2/3)

–EoE in pediatrics (c)

–Chronic obstructive pulmonary disease ("COPD")

–Bullous pemphigoid (Phase 2/3) (c)

–Bullous pemphigoid (c)

–Chronic spontaneous urticaria ("CSU")

–Chronic inducible urticaria - cold

–Chronic rhinosinusitis without nasal polyposis

–Allergic fungal rhinosinusitis

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

–EoE in adults and adolescents (EU)

–Prurigo nodularis (EU and Japan)

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

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

–Approved by FDA 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 for prurigo nodularis

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

–Chronic pruritus of unknown origin

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

–Prurigo nodularis (Japan)

–CSU in adults and adolescents (U.S.

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

–Approved by EC for EoE in adults and adolescents

–Reported that Phase 3 trial in COPD with evidence of type 2 inflammation met its primary and all key secondary endpoints

–Phase 3 trial in chronic cold induced urticaria did not meet its required efficacy endpoints

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

–EC decision on regulatory submission for EoE in adults and adolescents (first half 2023)

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

–Report results from replicate Phase 3 trial in COPD (mid-2024)

–FDA decision on sBLA (target action date of October 22, 2023) and MHLW decision on regulatory submission (first half 2024) for CSU in adults and adolescents

Clinical Program (continued)

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Dupixent (dupilumab) (b)

–Chronic pruritus of unknown origin

–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

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

–EC decision on regulatory submission for prurigo nodularis (first half 2023)

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

–Discontinued further clinical development in allergic fungal rhinosinusitis and chronic rhinosinusitis without nasal polyposis

Kevzara (sarilumab) (b)

Antibody to IL-6R

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

–Systemic juvenile idiopathic arthritis ("sJIA")

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

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –Approved by FDA for PMR

–Submit sBLA and regulatory application in the EU for pcJIA (second half 2023)

Itepekimab (b) (REGN3500)

Antibody to IL-33

–Report results from Phase 3 study in COPD (2025)

REGN5713-5714-5715

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Solid Organ Oncology

Libtayo (cemiplimab) (n)(g)

Libtayo (cemiplimab) (g)

Antibody to PD-1

–Metastatic or locally advanced CSCC (d)

–First-line NSCLC, BNT116 combination

–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 and Japan)

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

–European Medicines Agency's Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for cervical cancer

–Voluntarily withdrew sBLA for cervical cancer due to inability to align with FDA on certain post-marketing studies –FDA decision on sBLA (fourth quarter 2022) (o) and EC decision on regulatory submission (first half 2023) for NSCLC, chemotherapy combination

–EC decision on regulatory submission for cervical cancer (first quarter 2023)

–Approved by EC for first-line NSCLC, chemotherapy combination

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line advanced NSCLC (Phase 2/3) (pivotal study)

–First-line metastatic melanoma

–First-line adjuvant melanoma

–Initiate Phase 3 study (in combination with Libtayo) in perioperative melanoma (second 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

Clinical Program (continued)

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2023 Events to Date Select Upcoming Milestones

Libtayo (cemiplimab) (n)(g)

–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

Fianlimab (f)

Antibody to LAG-3

–Solid tumors and advanced hematologic malignancies –First-line metastatic melanoma –Presented positive data from Phase 1 trial (in combination with Libtayo) in advanced melanoma at ESMO Congress 2022

–Initiate Phase 3 study in first-line adjuvant melanoma (fourth quarter 2022)

Immune activator targeting TLR9

–CSCC and Merkel cell carcinoma –Initiate Phase 2 study in melanoma and other solid tumors

Ubamatamab (f)

Bispecific antibody targeting MUC16 and CD3

–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

–Platinum-resistant ovarian cancer

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

Bispecific antibody targeting MUC16 and CD28

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Bispecific antibody targeting PSMA and CD28

–Prostate cancer –Reported preliminary data from dose escalation portion of Phase 1/2 study in prostate cancer

–Prostate cancer

–Report additional results from Phase 1/2 study (in combination with Libtayo) in prostate cancer (second half 2023/first half 2024)

Bispecific antibody targeting PSMA and CD3

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Bispecific antibody targeting two distinct MET epitopes

–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

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

–MET-altered advanced NSCLC

REGN5093-M114

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–Solid tumors

Odronextamab (REGN1979)

Odronextamab (i) (REGN1979)

Bispecific antibody targeting CD20 and CD3

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–B-cell non-Hodgkin lymphoma

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

–Report additional results from potentially pivotal Phase 2 study in B-NHL (second half 2022)

–Submit BLA for B-NHL (second half 2023)

–Initiate Phase 3 program (first half 2023)

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

–Initiate Phase 3 studies in follicular lymphoma ("FL") and diffuse large B-cell lymphoma ("DLBCL"), including earlier lines of therapy (second quarter 2023)

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

Odronextamab (i) (REGN1979)

–Submit BLA and Marketing Authorization Application ("MAA") for relapsed/refractory FL and DLBCL (second half 2023)

Bispecific antibody targeting CD22 and CD28

Linvoseltamab (f)

Bispecific antibody targeting BCMA and CD3

–Multiple myeloma (c)

–Multiple myeloma (potentially pivotal study) (c)

–Completed enrollment in potentially pivotal Phase 2 study in multiple myeloma –Report results from potentially pivotal Phase 2 study in multiple myeloma (fourth quarter 2022)

–Multiple myeloma (c)(e)

–Multiple myeloma (pivotal study) (c)(e)

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

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

Bispecific antibody targeting BCMA and CD3

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studied as monotherapy and in combination with cemdisiran

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

–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)

–Submit BLA for CD55-deficient protein-losing enteropathy, monotherapy (fourth quarter 2022)

Cemdisiran (k)

siRNA therapeutic targeting C5

–Immunoglobulin A nephropathy

–Reported positive topline results from Phase 2 trial in immunoglobulin A nephropathy

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

–CHAPLE, monotherapy (adults and children aged 1 year and older) (U.S.)

–FDA decision on BLA for CHAPLE, monotherapy (target action date of August 20, 2023)

Antibody to IL2Rg

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–Transthyretin ("ATTR") amyloidosis (c)

–Reported positive interim data from Phase 1 trial in ATTR

Antibody to Factor XI

Antibody to TMPRSS6

–Transfusion dependent iron overload

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2023 Events to Date Select Upcoming Milestones

General Medicine

REGEN-COV (casirivimab and imdevimab) (e)(i)

Multi-antibody therapy to SARS-CoV-2 virus

–COVID-19 treatment of non-hospitalized patients and pre-and post-exposure prophylaxis (U.S.)

–COVID-19 treatment of hospitalized patients (EU) –Submitted additional data to the FDA from prophylaxis trial in connection with BLA

–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 for COVID-19 treatment of non-hospitalized patients and prevention

–EC decision on regulatory submission for COVID-19 treatment of hospitalized patients (fourth quarter 2022)

"Next Generation" Covid Antibodies

Antibodies to SARS-CoV-2 variants

–Healthy volunteers

–Initiate clinical development of "next generation" antibody (mid-2023)

Praluent (alirocumab)

Antibody to PCSK9

–HeFH in pediatrics

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

Evkeeza (evinacumab) (f)(l)

Antibody to ANGPTL3

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

–Submit sBLA for HoFH in pediatrics (5–11 years of age)

–Approved by FDA for HoFH in pediatrics (5–11 years of age)

Garetosmab (f) (REGN2477)

6 unchanged sentences

–Partial lipodystrophy

Clinical Program (continued)

Phase 1 Phase 2 Phase 3 Regulatory Review (h)

2022 Events to Date Select Upcoming Milestones

REGN5381/REGN9035

Agonist antibody to NPR1/reversal agent to REGN5381

–Reversal agent in healthy volunteers –Heart failure

–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 (fourth quarter 2022)

("NASH") –NASH

RNAi therapeutic targeting PNPLA3

RNAi therapeutic targeting APP

–Early-onset Alzheimer’s disease

–Early-onset Alzheimer’s disease (q)

–Reported positive interim data from single dose part of Phase 1 trial in early-onset Alzheimer’s disease

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.

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");

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

We have discontinued 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

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

(i) In collaboration with Roche outside the United States

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

(j) In collaboration with Intellia

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(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) An FDA travel complication related to scheduling a routine clinical trial site inspection in eastern Europe has delayed the FDA's decision on the NSCLC chemotherapy combination sBLA until after the September 19, 2022 target action date.

(p) Studied in combination with ubamatamab

(n) Studied in combination with ubamatamab

(o) 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.

(p) Studied in combination with odronextamab

(q) Part B of the study (multi-dose regimen) has been placed on partial clinical hold in the U.S.

by the FDA due to findings observed in prior non-clinical chronic toxicology studies.

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 intends to use a priority review voucher in connection with the submission of the BLA for DME and wet AMD, which is currently planned for late 2022.

REGEN-COV (casirivimab and imdevimab)

REGEN-COV 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.

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.

The FDA has notified the Company that its review of the BLA for REGEN-COV to treat COVID-19 in non-hospitalized patients and as prophylaxis in certain individuals is ongoing.

Agreements Related to COVID-19

In 2020, the Company 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.

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.

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

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

Pursuant to the agreement, the U.S.

government was obligated to purchase all filled and finished doses of such additional drug product delivered by January 31, 2022, resulting in payments to the Company of $2.940 billion in the aggregate.

Additionally, Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S.

government (see "Roche" section below for further details regarding our collaboration agreement with Roche).

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 during the three and nine months ended September 30, 2021.

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).

Under the terms of the agreement, the parties jointly fund certain studies and 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.

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.

In March 2023, the Company and Sanofi announced that the primary and all key secondary endpoints were met in the BOREAS trial (the first of two Phase 3 trials) in adults currently on maximal standard-of-care inhaled therapy (triple therapy) with uncontrolled COPD and evidence of type 2 inflammation.

In this trial, patients receiving Dupixent experienced a 30% reduction in moderate or severe acute COPD exacerbations (rapid and acute worsening of respiratory symptoms) over 52 weeks, while also demonstrating significant improvements in lung function, quality of life, and COPD respiratory symptoms.

The safety results were generally consistent with the known safety profile of Dupixent in its approved indications.

Collaboration, License, and Other Agreements

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, Sanofi is generally responsible for funding 80% to 100% of agreed-upon 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;

As of June 30, 2022, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $3.1 billion.

Under the terms of the Antibody License and Collaboration Agreement, 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 Antibody License and Collaboration Agreement 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%.

as of December 31, 2022, the total amount of our contingent reimbursement obligation to Sanofi in connection with such development expenses was approximately $2.9 billion.

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 the years ended 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-month basis, and, in first quarter of 2022, the Company earned a $50.0 million sales-based milestone upon aggregate sales of antibodies outside the United States exceeding $2.0 billion.

We are entitled to receive up to an aggregate of $100.0 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 $2.5 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.

Immuno-Oncology

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

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.

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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").

Consequently, in July 2022, we made a $900.0 million up-front payment to Sanofi, and Sanofi is eligible to receive a $100.0 million regulatory milestone and up to an aggregate of $100.0 million in sales-based milestones upon achieving certain amounts of worldwide net product sales of Libtayo through 2023.

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

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.

We also pay 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.

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

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.

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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.

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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 MTPC.

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

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

As of September 30, 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.

Following designation of a lead candidate, the parties may further advance such lead candidate under either a co-commercialization collaboration agreement structure (under which the parties are advancing ALN-APP, which is currently in clinical development) or a license agreement.

In addition, during 2019, the parties entered into a Co-Commercialization Collaboration Agreement for a silencing RNA ("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 potential future net sales of the combination product only subject to customary reductions, as well as up to $325.0 million in sales milestones.

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 two $100.0 million clinical proof-of-principle milestones for each of the eye and CNS programs (an aggregate of $200.0 million in development milestones).

Under the terms of 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 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 ("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").

In addition, we have an option to extend the Research Term for an additional five-year period for a research extension fee of $300.0 million.

At the stage of designation of a lead candidate for CNS programs and liver programs, the parties have alternating rights to be a lead party for collaboration products.

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-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.

The licensee will be responsible for its own costs and expenses incurred in connection with the development and commercialization of the collaboration products under the License Agreement.

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, 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.

Under the terms of 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, a small interfering RNA ("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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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 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.

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

See "Agreements Related to COVID-19 - U.S.

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

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.

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

Following this approval, Kiniksa is solely responsible for the U.S.

development and commercialization of ARCALYST in all approved indications, and Regeneron will continue to supply clinical and commercial product to Kiniksa.

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.

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.

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

Ultragenyx will share in certain costs for global trials led by the Company and also have the right to continue to clinically develop Evkeeza in countries outside of the U.S.

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.

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.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent.

Our ability to generate profits and to generate positive cash flow from operations over the next several years depends significantly on the continued success in commercializing EYLEA and Dupixent, as well as on whether we are able to obtain regulatory approval for aflibercept 8 mg and are successful in commercializing it.

We expect to continue to incur substantial expenses related to our research and development activities, a portion of which we expect to be reimbursed by our collaborators.

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Results of Operations

Three and Nine Months Ended September 30, 2022 and 2021

Three Months Ended March 31, 2023 and 2022

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except per share data) 2023 2022

8 unchanged sentences

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2022 2021 $ Change 2022 2021 $ Change

(In millions) 2023 2022 $ Change

Net product sales:

5 unchanged sentences

40.2 33.6 6.6

REGEN-COV - U.S.

— 676.7 (676.7) — 3,530.1 (3,530.1)

Evkeeza - U.S.

13.6 6.6 7.0 33.2 9.1 24.1

Inmazeb - U.S.

3.0 — 3.0 3.0 — 3.0

ARCALYST ** - U.S.

Total net product sales $ 1,668.0 $ 1,638.6 $ 29.4

Collaboration revenue:

2 unchanged sentences

Roche 222.2 216.3 5.9

Other collaboration revenue — — — 0.4 — 0.4

Other 0.6 — 0.6

Other revenue 116.0 94.0 22.0

Total revenues $ 3,162.1 $ 2,965.1 $ 197.0

* Percentage not meaningful

** Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States.

Previously, the Company recorded net product sales of ARCALYST in the United States.

* Not meaningful

Net Product Sales

Net product sales of EYLEA in the United States increased for the three and nine months ended September 30, 2022, compared to the same periods in 2021, due to higher sales volume partly offset by an increase in sales-related deductions.

As described under "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above, effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo worldwide and began recording net product sales of Libtayo outside the United States.

During the three and nine months ended September 30, 2021, we recorded net product sales of REGEN-COV in connection with our agreements with the U.S.

As of December 31, 2021, the Company had completed its final deliveries of drug product under its agreements with the U.S.

as a result, there were no net product sales of REGEN-COV in the United States recorded during the three and nine months ended September 30, 2022.

Refer to "Agreements Related to COVID-19 - U.S.

Government " section above for further details.

Net product sales of EYLEA in the United States decreased for the three months ended March 31, 2023, compared to the same period in 2022, primarily due to an increase in sales-related deductions, partly offset by higher sales volume.

As described in "Collaboration, License, and Other Agreements - Sanofi - Immuno-Oncology " above, effective July 1, 2022, the Company became solely responsible for the research, development, and commercialization of Libtayo worldwide and began recording net product sales of Libtayo outside the United States.

Collaboration Revenue

1 unchanged sentence

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

Regeneron's share of profits in connection with commercialization of antibodies $ 636.5 $ 415.3

Sales-based milestone earned

— 50.0 50.0 50.0

Sales-based milestones earned — 50.0

Reimbursement for manufacturing of commercial supplies (a)

160.5 144.7 466.8 361.2

Other (0.2) — 28.7 —

Total Antibody 798.4 626.1

Immuno-oncology:

Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States — (3.0) 6.7 (12.6)

Reimbursement for manufacturing of ex-U.S.

commercial supplies (a)

— 3.1 4.6 10.5

Total Immuno-oncology — 4.8

Total Sanofi collaboration revenue $ 798.4 $ 630.9

(a) Corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing

Global net product sales of Dupixent and Kevzara are recorded by Sanofi.

Sanofi provides us with an estimate of our share of the profits or losses from commercialization of antibodies for the most recent fiscal quarter;

these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profits or losses is adjusted accordingly, as necessary.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", on July 1, 2022, an amendment to the Antibody License and Collaboration Agreement became effective, pursuant to which the percentage of Regeneron's share of profits in any calendar quarter used to reimburse Sanofi for development costs which were funded by Sanofi increased from 10% to 20%.

The increase in our share of profits in connection with commercialization of antibodies during the three and nine months ended September 30, 2022, compared to the same periods in 2021, was driven by higher Dupixent profits, partly offset by a one-time payment, recorded during the third quarter of 2022, in connection with this amendment.

In addition, given the recent U.S.

dollar strengthening against several foreign currencies, including the Japanese yen and the euro, the amount of the share of profits we receive in connection with commercialization of antibodies outside the United States was impacted in the third quarter of 2022.

(a) Corresponding costs incurred by the Company in connection with such production is recorded within Cost of collaboration and contract manufacturing.

Global net product sales of Dupixent and Kevzara are recorded by Sanofi in connection with the Antibody Collaboration.

As described above under "Collaboration, License, and Other Agreements - Sanofi - Antibody ", on July 1, 2022, an amendment to the LCA became effective, pursuant to which the percentage of Regeneron's share of profits in any calendar quarter used to reimburse Sanofi for development costs which were funded by Sanofi increased from 10% to 20%.

The increase in our share of profits in connection with commercialization of antibodies during the three months ended March 31, 2023, compared to the same period in 2022, was driven by profits associated with higher Dupixent sales, partly offset by the impact of the amendment to the LCA.

Regeneron's share of profits in connection with the commercialization of Dupixent and Kevzara is summarized below:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

4 unchanged sentences

(74.9) (46.9)

One-time payment in connection with amendment to the Antibody License and Collaboration Agreement (56.9) — (56.9) —

Regeneron's share of profits in connection with commercialization of antibodies

1 unchanged sentence

Regeneron's share of collaboration profits as a percentage of Dupixent and Kevzara net product sales 25% 22%

During the nine months ended September 30, 2022, 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 $2.0 billion on a rolling twelve-month basis.

During the three months ended September 30, 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 $1.5 billion on a rolling twelve-month basis.

During the three months ended March 31, 2022, 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 $2.0 billion on a rolling twelve-month basis.

As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last period in which Sanofi collaboration revenue was recognized in connection with the IO Collaboration.

Bayer Collaboration Revenue

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

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commercial supplies (a)

17.5 14.0 60.3 41.6

One-time payment in connection with change in Japan arrangement

One-time payment in connection with change in Japan arrangement (b)

Total Bayer collaboration revenue $ 356.9 $ 385.3

(a) Corresponding costs incurred by us in connection with such production is recorded within Cost of collaboration and contract manufacturing

(a) Corresponding costs incurred by the Company in connection with such production is recorded within Cost of collaboration and contract manufacturing.

(b) 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.

Bayer records net product sales of EYLEA outside the United States.

Bayer provides us with an estimate of our share of the profits from commercialization of EYLEA outside the United States for the most recent fiscal quarter;

these estimates are reconciled to actual results in the subsequent fiscal quarter, and our portion of the profit is adjusted accordingly, as necessary.

In addition, given the recent U.S.

dollar strengthening against several foreign currencies, including the Japanese yen and the euro, the amount of the share of profits we receive in connection with commercialization of EYLEA outside the United States was impacted in the third quarter of 2022.

Regeneron's share of profits in connection with commercialization of EYLEA outside the United States is summarized below:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

7 unchanged sentences

Regeneron's share of profits as a percentage of EYLEA net product sales outside the United States 39% 39%

* 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.

Roche Collaboration Revenue

As described above under "Agreements Related to COVID-19 - Roche ", Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from worldwide sales, depending on the amount of manufactured product supplied by each party to the market.

Each quarter, a single payment is due from one party to the other to true-up the global gross profits between the parties.

If Regeneron is to receive a true-up payment from Roche, such amount will be recorded to Collaboration revenue.

If Regeneron is to make a true-up payment to Roche, such amount will be recorded to Cost of goods sold.

Amounts recognized in Collaboration revenue in connection with the Roche collaboration agreement are as follows:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

Global gross profit payment from Roche in connection with sales of Ronapreve $ 222.2 $ 216.3

Roche provides us with an estimate of its gross profits for the most recent fiscal quarter;

these estimates are reconciled to actual results in the subsequent fiscal quarter, and the true-up of global gross profits is adjusted accordingly, as necessary.

Roche distributes and records net product sales of Ronapreve outside the United States, and the parties share gross profits from worldwide sales.

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions, except headcount data) 2022 2021 Change 2022 2021 Change

(In millions, except headcount data) 2023 2022 Change

Research and development (a)

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Average headcount 12,099 10,492 1,607

(a) Includes costs incurred as well as cost reimbursements from collaborators who are not deemed to be our customers

(a) Includes costs incurred net of any cost reimbursements from collaborators who are not deemed to be our customers

(b) Cost of collaboration and contract manufacturing includes costs we incur in connection with producing commercial drug supplies for collaborators and others.

Operating expenses included a total of $166.3 million and $136.9 million for the three months ended September 30, 2022 and 2021, respectively, and $493.0 million and $413.3 million for the nine months ended September 30, 2022 and 2021, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Operating expenses included a total of $238.7 million and $166.9 million for the three months ended March 31, 2023 and 2022, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Research and Development Expenses

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Indirect research and development expenses have not been allocated directly to each program, and primarily consist of costs to compensate personnel, overhead and infrastructure costs to maintain our facilities, and other costs related to activities that benefit multiple projects.

Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related external drug filling, packaging, and labeling costs.

Clinical manufacturing costs primarily consist of costs to manufacture bulk drug product for clinical development purposes as well as related drug filling, packaging, and labeling costs.

Clinical manufacturing costs also includes pre-launch commercial supplies which did not meet the criteria to be capitalized as inventory.

1 unchanged sentence

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022 *

$ Change 2022 2021 *

Direct research and development expenses:

Dupixent (dupilumab) $ 49.2 $ 32.1 $ 17.1

Fianlimab 34.8 3.4 31.4

Libtayo (cemiplimab) 32.9 38.6 (5.7)

Aflibercept 14.3 23.5 (9.2) 54.9 78.3 (23.4)

12.2 15.4 (3.2) 25.8 320.1 (294.3)

Aflibercept 8 mg 25.7 20.2 5.5

Odronextamab 22.1 11.5 10.6

Linvoseltamab 14.8 5.3 9.5

Other product candidates in clinical development and other research programs

14 unchanged sentences

* Certain prior year amounts have been reclassified to conform to the current year's presentation.

Total research and development expenses increased during the three months ended September 30, 2022 partially due to the impact of the amendments to the Sanofi collaboration agreements described under the "Collaboration, License, and Other Agreements" section above, including Sanofi no longer reimbursing us for 50% of Libtayo development costs incurred.

Reimbursement of research and development expenses by collaborators included $10.5 million and $138.3 million of reimbursements from Roche related to REGEN-COV for the three and nine months ended September 30, 2021, respectively.

For the three and nine months ended September 30, 2022, reimbursements from Roche related to REGEN-COV were not material.

Research and development expenses included stock-based compensation expense of $93.7 million and $73.1 million for the three months ended September 30, 2022 and 2021, respectively, and $275.8 million and $213.7 million for the nine months ended September 30, 2022 and 2021, respectively.

Total research and development expenses increased for the three months ended March 31, 2023, compared to the same period in 2022, partially due to the impact of the amendments to the Sanofi collaboration agreements (which were effective July 1, 2022) described under the "Collaboration, License, and Other Agreements" section above, as (i) Sanofi is no longer reimbursing us for 50% of Libtayo development costs and (ii) we recognize our 50% share of research and development expenses in connection with the Sanofi Antibody Collaboration.

Research and development expenses included stock-based compensation expense of $139.5 million and $92.4 million for the three months ended March 31, 2023 and 2022, respectively.

There are numerous uncertainties associated with drug development, including uncertainties related to safety and efficacy data from each phase of drug development, uncertainties related to the enrollment and performance of clinical trials, changes in regulatory requirements, changes in the competitive landscape affecting a product candidate, and other risks and uncertainties described in Part II, Item 1A.

"Risk Factors".

There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.

"Risk Factors." There is also variability in the duration and costs necessary to develop a pharmaceutical product, potential opportunities and/or uncertainties related to future indications to be studied, and the estimated cost and scope of the projects.

The lengthy process of seeking FDA and other applicable approvals, and subsequent compliance with applicable statutes and regulations, require the expenditure of substantial resources.

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Acquired In-process Research and Development ("IPR&D")

Acquired IPR&D for the nine months ended September 30, 2022 included a $195.0 million charge related to the Company's second quarter 2022 acquisition of Checkmate.

Additionally, Acquired IPR&D for the nine months ended September 30, 2022 included a $20.0 million opt-in payment in connection with a product candidate under our collaboration agreement with Adicet Bio, Inc.

Acquired IPR&D for the three months ended March 31, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Acquired IPR&D for the three months ended March 31, 2022

included a $20.0 million opt-in payment in connection with a product candidate under our collaboration agreement with Adicet Bio, Inc.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily due to higher headcount and headcount-related costs and an increase in commercialization-related expenses for Libtayo.

The increase in Selling, general, and administrative expenses for the nine months ended September 30, 2022 was also due to higher commercialization-related expenses for EYLEA, partly offset by costs in 2021 for educational campaigns related to COVID-19 that did not recur during 2022.

Selling, general, and administrative expenses also included stock-based compensation expense of $59.8 million and $48.7 million for the three months ended September 30, 2022 and 2021, respectively, and $178.0 million and $149.1 million for the nine months ended September 30, 2022 and 2021, respectively.

Cost of Goods Sold

Cost of goods sold decreased for the three and nine months ended September 30, 2022, compared to the same periods in 2021, primarily due to the Company not recognizing any REGEN-COV net product sales in the United States during 2022.

In addition, Cost of goods sold also decreased for the three and nine months ended September 30, 2022 since effective July 1, 2022, as a result of the A&R IO LCA described above, we are no longer obligated to pay Sanofi for their share of Libtayo U.S.

gross profits.

During the six months ended June 30, 2022, Cost of goods sold included $70.1 million related to Regeneron's obligation for Sanofi's share of Libtayo U.S.

gross profits.

Cost of goods sold for the nine months ended September 30, 2022 also decreased, compared to the same period in 2021, due to lower inventory write-offs and reserves ($101.3 million for the nine months ended September 30, 2022 compared to $188.0 million for the nine months ended September 30, 2021) primarily related to REGEN-COV.

Selling, general, and administrative expenses increased for the three months ended March 31, 2023, compared to the same period in 2022, primarily due to an increase in commercialization-related expenses for Libtayo outside the United States (as effective July 1, 2022, the Company became solely responsible for the commercialization of Libtayo worldwide), higher headcount and headcount-related costs, and higher contributions to an independent not-for-profit patient assistance organization.

These increases were partly offset by a decrease in commercialization-related expenses for EYLEA.

Selling, general, and administrative expenses also included stock-based compensation expense of $76.8 million and $60.7 million for the three months ended March 31, 2023 and 2022, respectively.

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing increased for the three months ended March 31, 2023, compared to the same period in 2022, primarily due to the recognition of costs in connection with manufacturing commercial supplies for Sanofi related to Praluent outside the United States and Dupixent globally.

Other Operating (Income) Expense

Other operating (income) expense, net, includes recognition of a portion of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with our Sanofi IO, Teva, and MTPC collaborative arrangements.

During the three months ended September 30, 2022, the Company discontinued further clinical development of fasinumab and, as a result, recorded $44.4 million (as an increase to other operating income) related to our Teva and MTPC collaborative arrangements as we deemed our obligation to provide development services in connection with these collaborative arrangements to be complete.

As the A&R IO LCA became effective July 1, 2022 (as further described under "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above), the three months ended June 30, 2022 was the last period in which such amounts were recognized in connection with our Sanofi immuno-oncology collaborative arrangement.

During the three months ended September 30, 2021, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the Sanofi IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $66.9 million as a reduction to other operating income.

Other operating (income) expense, net, for the three months ended March 31, 2022 included recognition of amounts previously deferred in connection with up-front and development milestone payments, as applicable, received in connection with our Sanofi IO, Teva, and MTPC collaborative arrangements.

As the A&R IO LCA became effective July 1, 2022, the three months ended June 30, 2022 was the last period in which such amounts were recognized in connection with our Sanofi IO Collaboration.

In addition, during the three months ended September 30, 2022, the Company discontinued further clinical development of fasinumab, and, as a result, we deemed our obligation to provide development services in connection with the Teva and MTPC collaborative arrangements to be complete.

Other Income (Expense)

Other income (expense) for the three and nine months ended September 30, 2022, compared to the same periods in 2021, was primarily impacted by the recognition of net unrealized gains on equity securities of $254.3 million and net unrealized losses of $120.6 million for the three and nine months ended September 30, 2022, respectively, compared to $29.1 million of net unrealized losses and $523.8 million of net unrealized gains for the three and nine months ended September 30, 2021, respectively.

Other income (expense) consists of the following:

Three Months Ended

September 30, Nine Months Ended

September 30,

(In millions) 2023 2022

Unrealized (losses) gains on equity securities, net $ (164.7) $ (211.2)

Interest income 95.2 18.5

Other (1.2) 8.9

Other (expense) income, net (70.7) (183.8)

Interest expense (18.0) (13.6)

Total other income (expense) $ (88.7) $ (197.4)

Three Months Ended

(In millions, except effective tax rate) 2023 2022

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Effective tax rate

12.9 % 10.2 % 11.1 % 14.3 %

The effective tax rate for the three months ended September 30, 2022, compared to the same period in 2021, included a lower benefit from stock-based compensation and a higher benefit from the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate (mainly due to no sales of REGEN-COV in the United States during 2022).

The effective tax rate for the nine months ended September 30, 2022, compared to the same period in 2021, included a favorable benefit from the proportion of income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate (including the impact from REGEN-COV income in 2021 described above), and, to a lesser extent, stock-based compensation.

The Company's effective tax rate for the three months ended March 31, 2023 was positively impacted, compared to the U.S.

federal statutory rate, primarily by stock-based compensation and income earned in foreign jurisdictions with tax rates lower than the U.S.

federal statutory rate.

The effective tax rate for the three months ended March 31, 2023 was positively impacted, compared to the same period in 2022, primarily by stock-based compensation.

Liquidity and Capital Resources

Our financial condition is summarized as follows:

September 30, December 31,

March 31, December 31,

(In millions) 2023 2022 $ Change

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$ 15,026.3 $ 14,334.1 $ 692.2

Borrowings and finance lease liabilities:

Long-term debt $ 1,981.1 $ 1,980.0 $ 1.1

Finance lease liabilities $ 720.0 $ 719.7 * $ 0.3

Working capital:

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$ 13,809.1 $ 12,742.8 $ 1,066.3

* The $719.7 million related to finance lease liabilities was classified within current liabilities as of December 31, 2021.

See " Tarrytown, New York Leases " section below for details.

As of September 30, 2022, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Nine Months Ended September 30, 2022 and 2021

Nine Months Ended

September 30,

Borrowings and finance lease liabilities:

Long-term debt $ 1,981.8 $ 1,981.4 $ 0.4

Finance lease liabilities $ 720.0 $ 720.0 $ —

As of March 31, 2023, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Three Months Ended March 31, 2023 and 2022

Three Months Ended

(In millions) 2023 2022 $ Change

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Cash flows used in investing activities $ (235.7) $ (1,705.3) $ 1,469.6

Cash flows used in financing activities $ (761.4) $ (99.2) $ (662.2)

Cash Flows from Operating Activities

As of September 30, 2022, Accounts receivable had decreased by $488.2 million, compared to December 31, 2021, driven by the Company's collection of amounts due from the U.S.

government in connection with REGEN-COV sales in the fourth quarter of 2021.

As of September 30, 2022, deferred tax assets increased by $466.7 million, compared to December 31, 2021, primarily related to the impact of the Tax Cuts and Jobs Act of 2017, which requires, for tax purposes, the capitalization and amortization of research and development expenses effective for years beginning after December 31, 2021.

Cash flows (used in) provided by financing activities $ (322.5) $ 64.7 $ (387.2)

Cash Flows from Investing Activities

Capital expenditures during the nine months ended September 30, 2022 included costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the ongoing construction of a fill/finish facility and related equipment) and Limerick, Ireland, as well costs incurred in connection with our expansion of the Tarrytown, New York campus.

We expect to incur capital expenditures of $580 million to $615 million for the full year of 2022 primarily in connection with the continued expansion of our manufacturing facilities (including the fill/finish facility) and the expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown, New York campus.

Payments for Libtayo intangible asset of $926.8 million during the nine months ended September 30, 2022 were related to our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide (as described in "Collaboration, License, and Other Agreements - Sanofi - Immuno-oncology " above).

Asset acquisition, net of cash acquired, of $230.3 million during the nine months ended September 30, 2022 was related to our second quarter 2022 acquisition of Checkmate.

Capital expenditures during the three months ended March 31, 2023 included costs incurred in connection with the expansion of our Tarrytown, New York campus, as well costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the ongoing construction of a fill/finish facility and related equipment).

We expect to incur capital expenditures of $800 million to $900 million for the full year of 2023 primarily in connection with the continued expansion of our research, preclinical manufacturing, and support facilities at our Tarrytown campus and our Rensselaer manufacturing facility (including the fill/finish facility).

Payments for Libtayo intangible asset of $100.9 million during the three months ended March 31, 2023 were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide (as described in "Collaboration, License, and Other Agreements - Sanofi - Immuno-Oncology " above).

Cash Flows from Financing Activities

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.147 billion during the nine months ended September 30, 2022, compared to $1.130 billion during the nine months ended September 30, 2021.

For information related to repurchases of Common Stock, see the " Share Repurchase Program " section below.

Share Repurchase Program

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $485.2 million during the three months ended March 31, 2023, compared to $521.6 million during the three months ended March 31, 2022.

For information related to repurchases of Common Stock, see " Share Repurchase Programs " section below.

Share Repurchase Programs

In November 2021, our board of directors authorized a share repurchase program to repurchase up to $3.0 billion of our Common Stock.

The share repurchase program permits the Company to make repurchases through a variety of methods, including open-market transactions (including pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Exchange Act), privately negotiated transactions, accelerated share repurchases, block trades, and other transactions in compliance with Rule 10b-18 of the Exchange Act.

Repurchases may be made from time to time at management’s discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.

compliance with Rule 10b-18 of the Exchange Act.

Share repurchases may be made from time to time at management's discretion, and the timing and amount of any such repurchases will be determined based on share price, market conditions, legal requirements, and other relevant factors.

The program has no time limit and can be discontinued at any time.

There can be no assurance as to the timing or number of shares of any repurchases in the future.

During the nine months ended September 30, 2022, we repurchased 2,721,305 shares of our Common Stock under the program and recorded the cost of the shares, or $1.659 billion, as Treasury Stock.

As of September 30, 2022, $1.186 billion remained available for share repurchases under the program.

Tarrytown, New York Leases

In March 2022, we entered into a Second Amended and Restated Lease and Remedies Agreement (the "Restated Lease") with BA Leasing BSC, LLC, an affiliate of Banc of America Leasing & Capital, LLC ("BAL"), as lessor (the "Lessor"), which amends, restates, and extends our lease of laboratory and office facilities in Tarrytown, New York (the "Facility").

In March 2022, we also entered into a Second Amended and Restated Participation Agreement (the "Restated Participation Agreement") with Bank of America, N.A., as administrative agent, the Lessor, and a syndicate of financial institutions as rent assignees (collectively with the Lessor, the "Participants"), which amends and restates the original Participation Agreement entered into in March 2017.

The original Participation Agreement and certain related agreements were amended and restated in order to, among other things, (i) effect a five-year extension of the original March 2022 maturity date of the $720.0 million lease financing (which was previously advanced in March 2017 to finance the purchase price for the Facility) and the end of the term of our lease of the Facility from the Lessor to March 2027, at which time all amounts outstanding thereunder will become due and payable in full, and (ii) modify the rate of the interest or yield that is payable to the Participants.

In accordance with the terms of the Restated Lease, we continue to pay all maintenance, insurance, taxes, and other costs arising out of the use of the Facility.

We are also required to make monthly payments of basic rent during the term of the Restated Lease in an amount equal to a variable rate per annum, which was modified in connection with the Restated Lease, to be an adjusted one-month forward-looking term

rate based on the Secured Overnight Financing Rate ("SOFR"), plus an applicable margin that varies with our debt rating and total leverage ratio.

The Restated Participation Agreement and Restated Lease include an option for us to elect to further extend the maturity date of the Restated Participation Agreement and the term of the Restated Lease for an additional five-year period, subject to the consent of all the Participants and certain other conditions.

We also have the option prior to the end of the term of the Restated Lease to (a) purchase the Facility by paying an amount equal to the outstanding principal amount of the Participants' advances under the Restated Participation Agreement, all accrued and unpaid yield thereon, and all other outstanding amounts under the Restated Participation Agreement, Restated Lease, and certain related documents or (b) sell the Facility to a third party on behalf of the Lessor.

The Restated Lease is classified as a finance lease as we have the option to purchase the Facility under terms that make it reasonably certain to be exercised.

The agreements governing the Restated Lease financing contain financial and operating covenants.

Such financial covenants and certain of the operating covenants are substantially similar to the covenants set forth in our credit facility.

The Company was in compliance with all such covenants as of September 30, 2022.

In January 2023, our board of directors authorized an additional share repurchase program to repurchase up to an additional $3.0 billion of our Common Stock.

The share repurchase program was approved under terms substantially similar to the share repurchase program above.

As of March 31, 2023, an aggregate of $3.051 billion remained available for share repurchases under the programs.

The table below summarizes the shares of our Common Stock we repurchased and the cost of the shares, which were recorded as Treasury Stock.

Three Months Ended

(In millions) 2023 2022

Number of shares 0.9 0.6

Total cost of shares $ 693.9 $ 352.0

Critical Accounting Estimates

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"Management's Discussion and Analysis of Financial Condition and Results of Operations" of our Annual Report on Form 10-K for the fiscal year ended December 31, 2022 (filed February 6, 2023).

There have been no material changes to critical accounting estimates during the nine months ended September 30, 2022.

There have been no material changes to critical accounting estimates during the three months ended March 31, 2023.

Future Impact of Recently Issued Accounting Standards

As of September 30, 2022, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.

As of March 31, 2023, the future adoption of recently issued accounting standards is not expected to have a material impact on the Company's financial position or results of operations.

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-Q

Item 2. Management’s Discussion and Analysis