What changed in this filing

/stocks — the workspaceLOADING

Item 2. Management’s Discussion and Analysis

2024-08-01 compared with 2024-05-02 · 208 added, 131 removed, 462 unchanged (42% of the section changed)

17 unchanged sentences

• coverage and reimbursement determinations by such payors and new policies and procedures adopted by such payors;

• unanticipated expenses;

• the costs of developing, producing, and selling products;

• the costs of developing, producing, and selling products or unanticipated expenses;

• 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;

3 unchanged sentences

These statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any such statements.

In evaluating such statements, shareholders and potential investors should specifically consider the various

factors identified under Part II, Item 1A.

"Risk Factors," which could cause actual events and results to differ materially from those indicated by such forward-looking statements.

In evaluating such statements, shareholders and potential investors should specifically consider the various factors identified under Part II, Item 1A.

"Risk Factors," which could cause actual events and results to differ materially from

those indicated by such forward-looking statements.

We do not undertake any obligation to update (publicly or otherwise) any forward-looking statement, whether as a result of new information, future events, or otherwise.

6 unchanged sentences

Three Months Ended

Six Months Ended

(In millions, except per share data) 2024 2023 2024 2023

20 unchanged sentences

Disease Territory

Dupixent (dupilumab) Injection (b) (continued)

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

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

Chronic obstructive pulmonary disease

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

16 unchanged sentences

Polymyalgia rheumatica ("PMR")

Polyarticular juvenile idiopathic arthritis ("pJIA")

REGEN-COV ®(d)

Evkeeza ® (evinacumab) Injection (e)

HoFH (in adults, adolescents, and pediatrics aged 5 years and older)

HoFH (in adults, adolescents, and pediatrics)

Inmazeb ® (atoltivimab, maftivimab, and odesivimab) Injection

4 unchanged sentences

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

Deficiency of interleukin-1 receptor antagonist ("DIRA") (in adults, adolescents, and pediatrics)

Deficiency of interleukin-1 receptor antagonist ("DIRA") (in adults, adolescents, and pediatrics) a

Product (continued)

Disease Territory

ARCALYST (rilonacept) Injection (f) (continued)

Recurrent pericarditis (in adults and adolescents)

12 unchanged sentences

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

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

The table below includes net product sales of Regeneron-discovered products.

Such net product sales are recorded by us or others, as further described in the footnotes to the table.

We believe the information in the table is useful to investors as it demonstrates our pipeline productivity and our ability to innovate, discover, and develop new products, and bring those products to market either alone or based on contractual arrangements with other parties, which has a direct impact on our results of operations and financial condition.

The table also shows the degree to which we, a collaborator, and/or a licensee is currently commercializing the products discovered by Regeneron.

In addition, this information allows management and investors to assess the commercial trends and developments impacting Regeneron-discovered products.

In arrangements where our collaborator or licensee is currently commercializing such products and is recording net product sales as a result, the net product sales shown in the table also are an important metric for management's review and assessment of (i) the revenues we record for our share of profits and/or royalties from such sales and (ii) the impact of our obligation to supply commercial product to certain of these collaborators or licensees.

Three Months Ended

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$ 30.9 $ 20.8 $ 51.7 $ 22.5 $ 16.9 $ 39.4 31 %

(a) Regeneron records net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States.

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

(b) Sanofi records global net product sales of Dupixent and Kevzara, and the Company records its share of profits in connection with global sales of such products.

(c) 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.

Included in this line item for the first quarter of 2023 is approximately $6 million of net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).

(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) Roche records net product sales outside the United States and the parties share gross profits from sales 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.

Six Months Ended

2024 2023 % Change

(In millions) U.S.

ROW Total (Total Sales)

EYLEA HD and EYLEA (a)

$ 2,936.3 $ 1,757.2 $ 4,693.5 $ 2,933.9 $ 1,733.4 $ 4,667.3 1 %

$ 4,828.2 $ 1,805.0 $ 6,633.2 $ 4,003.3 $ 1,271.1 $ 5,274.4 26 %

$ 341.6 $ 219.7 $ 561.3 $ 239.9 $ 152.7 $ 392.6 43 %

$ 126.1 $ 267.1 $ 393.2 $ 80.7 $ 205.5 $ 286.2 37 %

$ 115.1 $ 88.7 $ 203.8 $ 96.1 $ 81.9 $ 178.0 14 %

REGEN-COV (e)

$ — $ 2.3 $ 2.3 $ — $ 613.2 $ 613.2 (100 %)

Other products (f)

$ 56.2 $ 38.5 $ 94.7 $ 40.6 $ 33.4 $ 74.0 28 %

* Percentage not meaningful

(a) We record net product sales of EYLEA HD and EYLEA in the United States, and Bayer records net product sales outside the United States.

We record our share of profits in connection with sales outside the United States within Collaboration revenue;

refer to "Results of Operations - Revenues - Bayer Collaboration Revenue" below for such amounts.

(b) Sanofi records global net product sales of Dupixent and Kevzara, and we record our share of profits in connection with global sales of such products within Collaboration revenue.

Refer to "Results of Operations - Revenues - Sanofi Collaboration Revenue" below for such amounts.

Prior to July 1, 2022, Sanofi recorded net product sales of Libtayo outside the United States.

Included in this line item for the six months ended June 30, 2023 is approximately $6 million of first quarter 2023 net product sales recorded by Sanofi in connection with sales in certain markets outside the United States (Sanofi recorded net product sales in such markets during a transition period).

(d) We record net product sales of Praluent in the United States.

Sanofi records net product sales of Praluent outside the United States and pays us a royalty on such sales, which is recorded within Other revenue.

(e) Roche records net product sales outside the United States and we record our share of gross profits from sales based on a pre-specified formula, which is recorded within Collaboration revenue.

Refer to "Results of Operations - Revenues - Roche Collaboration Revenue" below for such amounts.

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

Refer to "Results of Operations - Revenues" below for a complete listing of net product sales recorded by us.

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

net product sales of ARCALYST were $71 million for the fourth quarter of 2023.

net product sales of ARCALYST were $79 million for the first quarter of 2024.

(g) Rest of world ("ROW")

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EYLEA HD (aflibercept) 8 mg (a)

–Two-year data for wAMD and DME (U.S.)

–Approved by European Commission ("EC") and Japan's Ministry of Health, Labour and Welfare ("MHLW") for wAMD and DME

–Initiate Phase 3 study in RVO (mid-2024) to enable U.S.

–Initiate Phase 3 study in RVO (second half 2024) to enable U.S.

Food and Drug Administration ("FDA") submission

–Submit supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (mid-2024)

–FDA decision on supplemental Biologics License Application ("sBLA") with two-year data for wAMD and DME (first half 2025)

Pozelimab (f) (REGN3918)

7 unchanged sentences

–Asthma in pediatrics (2–5 years of age)

–Chronic obstructive pulmonary disease

–Bullous pemphigoid (c)

1 unchanged sentence

–EoE in pediatrics (1–11 years of age) (EU)

–COPD with type 2 inflammatory phenotype (U.S., EU, and Japan)

–CRSwNP in adolescents

–COPD with type 2 inflammatory phenotype (U.S.

–CSU in adults and adolescents (EU)

–Approved by FDA for EoE in pediatrics (1–11 years of age)

–Results from Phase 3 trial in pediatrics (1–11 years of age) with EoE published in New England Journal of Medicine (" NEJM ")

–Approved by MHLW for CSU in adults and adolescents

–Approved by EC for uncontrolled COPD characterized by raised blood eosinophils

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

results presented at 2024 American Thoracic Society International Conference and published in NEJM

–EC decision on regulatory submission for EoE in pediatrics (second half 2024)

–FDA decision on sBLA (target action date of June 27, 2024) and EC decision on regulatory submission (second half 2024) for COPD with type 2 inflammatory phenotype

–FDA decision on sBLA

for CRSwNP in

adolescents (target action date of September 15, 2024)

–FDA decision on sBLA for COPD with type 2 inflammatory phenotype (target action date of September 27, 2024)

–EC decision on regulatory submission for CSU in adults and adolescents (first half 2025)

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Select Upcoming

Dupixent (dupilumab) (b)

–FDA extended by three months target action date of its priority review of sBLA for COPD with type 2 inflammatory phenotype

Kevzara (sarilumab) (b)

Antibody to IL-6R

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

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study) –PMR (EU)

–Systemic juvenile idiopathic arthritis ("sJIA") (pivotal study)

–Approved by FDA for pJIA

–EC decision on regulatory submission for PMR (second half 2024)

–FDA decision on sBLA (target action date of June 10, 2024) and EC decision (second half 2024) on regulatory submission for pcJIA

–EC decision on regulatory submission for pJIA (first half 2025)

Itepekimab (b) (REGN3500)

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–Non-cystic fibrosis bronchiectasis ("NCFB")

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

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

REGN5713-5714-5715

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–Conduct interim analysis from Phase 3 study in adjuvant CSCC (second half 2024)

–Submit regulatory application in Japan for NSCLC, monotherapy and chemotherapy combination (second half 2024)

Fianlimab (f) (REGN3767)

Antibody to LAG-3

–First-line advanced NSCLC (Phase 2/3) (pivotal study)

–First-line advanced NSCLC (Phase 2/3)

–Perioperative NSCLC

–Perioperative melanoma (Phase 2/3)

–First-line metastatic melanoma (e)

–First-line adjuvant melanoma

–Initiate potentially pivotal Phase 2 study (in combination with Libtayo) in perioperative melanoma (first half 2024)

–Initiate Phase 2 study (in combination with Libtayo) in perioperative NSCLC (first half 2024)

–First-line metastatic melanoma versus the combination of relatlimab and nivolumab

–Initiate Phase 2 study (in combination with Libtayo) in perioperative head and neck squamous cell carcinoma (2025)

–Initiate Phase 3 study (in combination with Libtayo) in first-line metastatic melanoma versus the combination of relatlimab and nivolumab (second half 2024)

–Report results from Phase 3 study in first-line metastatic melanoma (2025)

–Report initial data from Phase 2/3 study in first-line advanced NSCLC (fourth quarter 2024)

Clinical Program (continued)

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Select Upcoming

Fianlimab (f) (REGN3767)

–Report results from Phase 3 study in first-line metastatic melanoma (2025)

–Report initial data from Phase 2/3 study in first-line advanced NSCLC (second half 2024)

Immune activator targeting TLR9

–Solid tumors –Company paused enrollment in Phase 2 study related to drug supply

–Company discontinued Phase 2 study due to drug supply

Ubamatamab (f) (REGN4018)

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–Prostate cancer

–Initiate cohorts in combination with REGN4336 (PSMAxCD3) in metastatic castration-resistant prostate cancer (first half 2024)

Bispecific antibody targeting EGFR and CD28

–Solid tumors

–Presented positive results from dose escalation portion of Phase 1/2 trial (in combination with Libtayo) in advanced solid tumors at American Society of Clinical Oncology ("ASCO") 2024 Annual Meeting

Pozelimab (f) (REGN3918)

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–FDA issued Complete Response Letters ("CRLs") for BLA for relapsed/refractory FL and DLBCL due to enrollment status of confirmatory Phase 3 trials

–European Medicines Agency's ("EMA") Committee for Medicinal Products for Human Use ("CHMP") adopted positive opinion for relapsed/refractory FL and DLBCL

–EC decision on Marketing Authorization Application ("MAA") for relapsed/refractory FL and DLBCL (second half 2024)

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

Linvoseltamab (f) (REGN5458)

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–Earlier (pre-malignant) multiple myeloma

–Monoclonal gammopathy of undetermined significance ("MGUS")

–Light chain amyloidosis ("ALA")

–Multiple myeloma (c)(e)

–Relapsed/refractory multiple myeloma (U.S.

–Presented 14-month median follow-up data from pivotal Phase 1/2 trial in multiple myeloma at European Hematology Association ("EHA") Congress 2024 and published these data in Journal of Clinical Oncology

–FDA decision on BLA (target action date of August 22, 2024) and EC decision on MAA (first half 2025) for relapsed/refractory multiple myeloma

Clinical Program (continued)

Phase 2 Phase 3 Regulatory

2024 Events to Date

Select Upcoming

NTLA-2001 (j)

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–Thrombosis –Report results from Phase 2 study in thrombosis (second half 2024)

Antibody to Factor XI

Antibody to IL2Rg

–Aplastic anemia

Internal Medicine/Genetic Medicines

5 unchanged sentences

Antibody to myostatin (GDF8)

–Healthy volunteers

–Initiate Phase 2 obesity study of trevogrumab in combination with semaglutide with and without garetosmab (mid-2024)

Mibavademab (f) (REGN4461)

Mibavademab (f)(p) (REGN4461)

Agonist antibody to leptin receptor ("LEPR")

2 unchanged sentences

–Heart failure

Rapirosiran (ALN-HSD) (k)

RNAi therapeutic targeting HSD17B13

–Nonalcoholic steatohepatitis

RNAi therapeutic targeting APP

–Cerebral amyloid angiopathy ("CAA")

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

10 unchanged sentences

(j) In collaboration with Intellia

(k) In collaboration with Alnylam

(l) Under the terms of our license agreement for the combination consisting of cemdisiran and pozelimab, Alnylam is entitled to receive royalties on sales of the combination (if any), as well as sales milestones.

(k) 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.

(l) Under the terms of our license agreement for cemdisiran, Alnylam is entitled to receive royalties on sales (if any), as well as sales milestones.

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

(n) Company is seeking accelerated approval in the United States

(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.

(o) Studied in combination with semaglutide with and without garetosmab

(p) A Phase 2 study, sponsored by Eli Lilly, is also ongoing and testing the combination of tirzepatide and mibavademab compared with tirzepatide alone in patients with obesity.

Additional Information - Clinical Development Programs

Dupixent (dupilumab)

In May 2024, the FDA extended by three months the target action date of its priority review of the sBLA for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD.

The FDA had requested additional analyses on the efficacy of Dupixent in the BOREAS and NOTUS pivotal trials.

Based on the submission of these analyses, the agency determined that this additional information constituted a major amendment to the sBLA and extended the target action date accordingly.

The revised target action date is September 27, 2024.

Linvoseltamab

During its review of the linvoseltamab BLA for relapsed/refractory multiple myeloma, the FDA informed us that the third-party fill/finish provider for linvoseltamab had unresolved findings from a pre-approval inspection for another company's product candidate, which is to be filled on the same manufacturing line as linvoseltamab.

Although this third-party fill/finish provider communicated to us and the FDA that they believe these findings have been successfully remediated, the FDA has indicated that a re-inspection will be required before these issues are considered resolved and any new products filled on this line can be approved, including linvoseltamab.

Therefore, we believe that any potential FDA approval of the linvoseltamab BLA will be delayed beyond the August 22, 2024 target action date.

The FDA has not informed us of any approvability issues for linvoseltamab related to safety, efficacy, or the status of our confirmatory trial.

Early-Stage Clinical Development Updates

In 2024, a Phase 1 study of linvoseltamab, in combination with dupilumab, in severe food allergy was initiated.

A Phase 1/2 study of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to mutations of the oteoferlin gene is ongoing.

The Company will present updated data from the Phase 1/2 trial at the May 2024 American Society of Gene and Cell Therapy ("ASGCT") annual conference.

A Phase 1/2 study of DB-OTO, an AAV-based gene therapy, in children with profound genetic hearing loss due to mutations of the otoferlin gene is ongoing.

In May 2024, the Company presented updated data from the Phase 1/2 trial at the American Society of Gene and Cell Therapy ("ASGCT") annual conference and announced that DB-OTO improved hearing to normal levels in one child and that initial hearing improvements were observed in a second child.

Additionally, the FDA granted DB-OTO Regenerative Medicine Advanced Therapy ("RMAT") designation.

In 2024, a Phase 1 combination cohort of nezastomig and REGN4336 (bispecific antibody targeting PSMA and CD3) in metastatic castration-resistant prostate cancer was initiated.

Collaboration, License, and Other Agreements

3 unchanged sentences

however, we are only required to apply 20% of our share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses.

As of March 31, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.200 billion.

As of June 30, 2024, the total amount of our contingent reimbursement obligation to Sanofi (i.e., "development balance") in connection with such development expenses was approximately $2.013 billion.

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.

1 unchanged sentence

We supply certain commercial bulk product to Sanofi.

We and Sanofi equally share profits from sales within the United States.

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).

We and Sanofi equally share profits from sales within the United States, and 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).

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

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

In 2019, we and Alnylam Pharmaceuticals, Inc.

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.

During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for the ALN-APP program and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

Under the terms of the collaboration, the parties 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) 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").

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.

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.

Alnylam is the lead party for ALN-APP.

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.

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.

The parties have entered into various license agreements, including for a combination consisting of cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway being developed by Alnylam) and pozelimab, with us as the licensee.

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

to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.

We and Alnylam Pharmaceuticals, Inc.

are parties to a 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.

During 2023, we paid a $100.0 million development milestone to Alnylam upon the achievement of specified proof-of-principle criteria for a CNS program (ALN-APP) and Alnylam is eligible to receive an additional $100.0 million clinical proof-of-principle milestone in connection with an eye program.

We have also entered into various license agreements with Alnylam, with us as the licensee, including for cemdisiran (a small interfering RNA ("siRNA") therapeutic targeting the C5 component of the human complement pathway) as a monotherapy and for a combination consisting of cemdisiran and pozelimab.

During the second quarter of 2024, we elected to no longer co-develop ALN-APP pursuant to a co-development/co-commercialization collaboration agreement;

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

We and Intellia Therapeutics, Inc.

are parties to a license and collaboration agreement to advance CRISPR/Cas9 gene-editing technology for in vivo therapeutic development.

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).

The collaboration was expanded in 2020 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 September 2023, we further expanded our existing collaboration to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.

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

In September 2023, we expanded the license and collaboration agreement to develop additional in vivo CRISPR-based gene editing therapies focused on neurological and muscular diseases.

Intellia will lead the design of the editing methodology, we will lead the design of the targeted viral vector delivery approach, and the parties share costs equally.

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In August 2023, we acquired Decibel by paying $101.3 million in cash (or $4.00 per share of Decibel common stock).

In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, entitling them to receive up to an additional $3.50 per share in cash upon achievement of certain clinical development and regulatory milestones for DB-OTO within specified time periods.

The maximum aggregate amount that holders of the CVRs may be entitled to receive if all the milestones contemplated by the CVRs are achieved is approximately $97 million.

In addition, Decibel shareholders received one non-tradeable contingent value right ("CVR") per share of Decibel common stock, entitling them to receive up to an additional $3.50 per share in cash upon achievement of certain development milestones for DB-OTO within specified time periods.

In July 2024, a development milestone contemplated by the CVRs was achieved, and, as a result, we became obligated to pay $55.1 million to the holders of the CVRs.

The holders of the CVRs may be entitled to receive an additional $42.0 million if an additional milestone contemplated by the CVRs is achieved.

In 2018, we entered into a collaboration agreement with bluebird bio, Inc.

3 unchanged sentences

Under the terms of the agreement, we made a $5.0 million up-front payment, and have assumed ongoing program, infrastructure, and personnel costs related to the product candidates acquired.

In addition, we are obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product;

obligated to pay 2seventy bio a regulatory milestone upon the first major market approval of the first approved product;

and, with respect to any approved product, a low single-digit percent royalty on sales.

In addition, we separately entered into sublease agreements for a portion of 2seventy bio's facilities.

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

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.

In addition, our research and development activities and related costs which are not reimbursed are expected to expand and require additional resources.

We expect to continue to incur substantial expenses related to our research and development activities, and our research and development activities and related costs which are not reimbursed by collaborators are expected to expand and require additional resources.

We also expect to incur substantial costs related to the commercialization of our marketed products.

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net

sales of our products;

Our financial results may fluctuate from quarter to quarter and will depend on, among other factors, the net sales of our products;

the scope and progress of our research and development efforts;

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Three Months Ended

Six Months Ended

(In millions, except per share data) 2024 2023 2024 2023

4 unchanged sentences

Income before income taxes 1,628.1 1,082.9 2,328.8 1,940.9

Income tax (benefit) expense

Income tax expense

195.8 114.5 174.5 154.7

Net income $ 1,432.3 $ 968.4 $ 2,154.3 $ 1,786.2

1 unchanged sentence

Three Months Ended

(In millions) 2024 2023 $ Change

Six Months Ended

(In millions) 2024 2023 $ Change 2024 2023 $ Change

Net product sales:

24 unchanged sentences

Net Product Sales

In August 2023, the FDA approved EYLEA HD in the United States.

Net product sales of EYLEA in the United States decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to changing market dynamics, resulting in lower volumes and a lower net selling price.

Total EYLEA HD and EYLEA net product sales in the U.S.

increased for the three and six months ended June 30, 2024, compared to the same periods in 2023.

EYLEA HD was approved by the FDA in August 2023 and EYLEA HD net product sales for the three and six months ended June 30, 2024 were driven by the transition of patients from other anti-VEGF products, including EYLEA, to EYLEA HD, as well as new patients naïve to anti-VEGF therapy.

Net product sales of EYLEA in the United States decreased for the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to (i) the aforementioned approval and transition of certain patients to EYLEA HD, and (ii) other market dynamics that resulted in lower volumes and a lower net selling price.

Collaboration Revenue

1 unchanged sentence

Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Regeneron's share of profits in connection with commercialization of antibodies $ 804.0 $ 636.5

Regeneron's share of profits

$ 988.3 $ 751.1 $ 1,792.3 $ 1,387.6

Reimbursement for manufacturing of commercial supplies (a)

157.3 192.6 263.1 354.5

Total Sanofi collaboration revenue $ 1,145.6 $ 943.7 $ 2,055.4 $ 1,742.1

(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, and we and Sanofi share profits on such sales.

Global net product sales of Dupixent and Kevzara are recorded by Sanofi, and we and Sanofi share profits on such sales.

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

Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Dupixent and Kevzara net product sales $ 3,666.1 $ 2,888.9 $ 6,837.0 $ 5,452.4

Regeneron's share of collaboration profits

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

$ 1,149.2 $ 857.8 $ 2,075.1 $ 1,569.2

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(160.9) (106.7) (282.8) (181.6)

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

Regeneron's share of profits

$ 988.3 $ 751.1 $ 1,792.3 $ 1,387.6

Regeneron's share of profits as a percentage of Dupixent and Kevzara net product sales

The increase in our share of profits in connection with commercialization of antibodies for the three months ended March 31, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

27% 26% 26% 25%

The increase in our share of profits for the three and six months ended June 30, 2024, compared to the same periods in 2023, was driven by higher profits associated with Dupixent sales.

Bayer Collaboration Revenue

Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States

Regeneron's share of profits

$ 353.0 $ 349.5 $ 686.9 $ 681.1

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commercial supplies (a)

22.1 27.2 44.2 52.5

Total Bayer collaboration revenue $ 375.1 $ 376.7 $ 731.1 $ 733.6

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Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

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(16.0) (14.0) (32.6) (29.3)

Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States

Regeneron's share of profits

$ 353.0 $ 349.5 $ 686.9 $ 681.1

Regeneron's share of profits as a percentage of EYLEA 8 mg and EYLEA net product sales outside the United States

39% 39% 39% 39%

Roche Collaboration Revenue

Three Months Ended

Six Months Ended

(In millions)

2024 2023 2024 2023

Global gross profit payment from Roche in connection with sales of Ronapreve $ 0.4 $ — $ 0.9 $ 222.2

— (3.8) — (3.8)

Total Roche collaboration revenue

$ 0.4 $ (3.8) $ 0.9 $ 218.4

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

For the three months ended March 31, 2024 and 2023, our share of gross profits in connection with sales of Ronapreve outside the United States was $0.5 million and $222.2 million, respectively.

Three Months Ended

(In millions, except headcount data) 2024 2023 Change

Six Months Ended

(In millions, except headcount data) 2024 2023 Change 2024 2023 Change

Research and development (a)

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Average headcount 14,176 12,412 1,764 13,926 12,256 1,670

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

(a) Includes costs incurred net of any cost reimbursements from collaborators

(b) Includes costs incurred in connection with producing commercial drug supplies for collaborators and others

Operating expenses for the three months ended March 31, 2024 and 2023 included a total of $230.1 million and $238.7 million, respectively, of stock-based compensation expense related to equity awards granted under our long-term incentive plans.

Operating expenses included stock-based compensation of $223.2 million and $202.0 million for the three months ended June 30, 2024 and 2023, respectively, and $453.3 million and $440.7 million for the six months ended June 30, 2024 and 2023, respectively.

Stock-based compensation expense relates to equity awards granted under our long-term incentive plans.

Research and Development Expenses

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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.

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

The table below also includes reimbursements of research and development expenses by collaborators, as when we are entitled to reimbursement of all or a portion of such expenses that we incur under a collaboration, we record those reimbursable amounts in the period in which such costs are incurred.

Three Months Ended

Six Months Ended

(In millions) 2024 2023 *

$ Change 2024 2023 *

Direct research and development expenses:

Fianlimab $ 51.0 $ 18.1 $ 32.9 $ 115.0 $ 52.9 $ 62.1

Linvoseltamab 63.3 14.8 48.5

Dupixent (dupilumab) 28.8 50.1 (21.3) 65.1 99.3 (34.2)

Odronextamab 34.3 19.6 14.7 60.3 41.8 18.5

Libtayo (cemiplimab) 22.6 32.9 (10.3)

EYLEA HD (aflibercept) 8 mg

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24.2 12.7 11.5 43.6 32.1 11.5

Linvoseltamab 23.1 26.3 (3.2) 86.4 41.1 45.3

Libtayo (cemiplimab) 20.2 25.4 (5.2) 42.8 58.3 (15.5)

19.8 12.8 7.0 31.8 22.7 9.1

Other product candidates in clinical development and other research programs

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

Research and development expenses included stock-based compensation expense of $123.0 million and $139.5 million for the three months ended March 31, 2024 and 2023, respectively.

Research and development expenses included stock-based compensation expense of $122.4 million and $109.1 million for the three months ended June 30, 2024 and 2023, respectively, and $245.4 million and $248.6 million for the six months ended June 30, 2024 and 2023, 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 product candidate, 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.

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.

Any failure by us to obtain, or delay in obtaining, regulatory approvals could materially adversely affect our business.

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

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 and six months ended June 30, 2024 primarily included up-front payments, as well as a premium on equity securities purchased, in connection with collaboration and licensing agreements.

Acquired IPR&D for the six months ended June 30, 2023 included a $45.0 million up-front payment in connection with our collaboration agreement with Sonoma Biotherapeutics, Inc.

Selling, General, and Administrative Expenses

Selling, general, and administrative expenses increased for the three months ended March 31, 2024, compared to the same period in 2023, due to an increase in commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs primarily related to the international expansion in support of Libtayo and hematology product launch preparations.

Selling, general, and administrative expenses also included stock-based compensation expense of $86.2 million and $76.8 million for the three months ended March 31, 2024 and 2023, respectively.

Selling, general, and administrative expenses increased for the three and six months ended June 30, 2024, compared to the same periods in 2023, due to higher commercialization-related expenses to support our launch of EYLEA HD and higher headcount and headcount-related costs partly related to our international commercial expansion.

Selling, general, and administrative expenses also included stock-based compensation expense of $82.6 million and $73.3 million for the three months ended June 30, 2024 and 2023, respectively, and $168.8 million and $150.1 million for the six months ended June 30, 2024 and 2023, respectively.

Cost of Goods Sold

Cost of goods sold increased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.

Cost of goods sold increased for the three and six months ended June 30, 2024, compared to the same periods in 2023, primarily due to higher start-up costs for our Rensselaer, New York fill/finish facility.

Cost of Collaboration and Contract Manufacturing

Cost of collaboration and contract manufacturing decreased for the three months ended March 31, 2024, compared to the same period in 2023, primarily due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.

Cost of collaboration and contract manufacturing decreased for the six months ended June 30, 2024, compared to the same period in 2023, partly due to the recognition of lower Dupixent manufacturing costs as a result of the transition to a higher-yielding manufacturing process.

Other Operating Expense (Income)

Other operating expense (income), net, for the three months ended March 31, 2024 reflects a $15.3 million charge related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Other operating expense (income), net, reflected charges of $14.6 million and $29.9 million, for the three and six months ended June 30, 2024, respectively, related to the increase in the estimated fair value of the contingent consideration liability recognized in connection with our 2023 acquisition of Decibel Therapeutics, Inc.

Other Income (Expense)

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Three Months Ended

Six Months Ended

(In millions) 2024 2023 2024 2023

Unrealized losses on equity securities, net

Unrealized gains (losses) on equity securities, net

$ 392.5 $ (30.9) $ 196.3 $ (195.6)

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Other 1.4 (2.1) 1.5 (3.3)

Other (expense) income, net (34.6) (70.7)

Other income (expense), net 573.3 85.3 538.7 14.6

Interest expense (14.8) (18.9) (30.9) (36.9)

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Three Months Ended

Six Months Ended

(In millions, except effective tax rate) 2024 2023 2024 2023

Income tax (benefit) expense

$ (21.3) $ 40.2

Income tax expense $ 195.8 $ 114.5 $ 174.5 $ 154.7

Effective tax rate

12.0 % 10.6 % 7.5 % 8.0 %

The Company's effective tax rate for the three months ended March 31, 2024 was positively impacted, compared to the U.S.

Our effective tax rate for the three and six months ended June 30, 2024 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, 2024 was positively impacted, compared to the same period in 2023, primarily by additional stock-based compensation.

federal statutory rate, partly offset by the remeasurement of existing uncertain tax positions.

Certain countries in which we have operations, including Ireland, have adopted legislation influenced by the Organization for Economic Co-operation and Development ("OECD") Global Anti-Base Erosion Model Rules ("Pillar Two") framework, including a minimum tax rate of 15%.

The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three months ended March 31, 2024.

The adoption of the Pillar Two framework did not have a material impact on our effective tax rate for the three and six months ended June 30, 2024.

It is uncertain whether the United States will enact legislation to adopt the Pillar Two framework.

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Our financial condition is summarized as follows:

March 31, December 31,

June 30, December 31,

(In millions) 2024 2023 $ Change

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Finance lease liabilities $ 720.0 $ 720.0 $ —

As of March 31, 2024, 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, 2024 and 2023

Three Months Ended

As of June 30, 2024, we also had borrowing availability of $750.0 million under a revolving credit facility.

Sources and Uses of Cash for the Six Months Ended June 30, 2024 and 2023

Six Months Ended

(In millions) 2024 2023 $ Change

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Cash flows used in investing activities $ (2,244.3) $ (2,622.6) $ 378.3

Cash flows provided by (used in) financing activities

Cash flows used in financing activities

$ (431.0) $ (936.7) $ 505.7

Cash Flows from Investing Activities

Capital expenditures for the three months ended March 31, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, New York location, as well as costs associated

with the expansion of our manufacturing facilities in Rensselaer, New York (including equipment related to the fill/finish facility).

We expect to incur capital expenditures of $780 million to $880 million for the full year of 2024 primarily in connection with the continued expansion of our facilities in Tarrytown and Rensselaer (including the fill/finish facility).

Payments for the Libtayo intangible asset of $27.9 million and $100.9 million for the three months ended March 31, 2024 and 2023, respectively, were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

Capital expenditures for the six months ended June 30, 2024 included costs incurred in connection with the expansion of our research, preclinical manufacturing, and support facilities at our Tarry town, N ew York location, as well as costs associated with the expansion of our manufacturing facilities in Rensselaer, New York (including the fill/finish facility).

We expect to incur

capital expenditures of $750 million to $820 million for the full year of 2024 primarily in connection with the continued expansion of our facilities in Tarrytown and Rensselaer (including the fill/finish facility).

Payments for the Libtayo intangible asset of $58.3 million and $121.8 million for the six months ended June 30, 2024 and 2023, respectively, were related to contingent consideration in connection with our acquisition of the exclusive right to develop, commercialize, and manufacture Libtayo worldwide.

Cash Flows from Financing Activities

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $682.1 million for the three months ended March 31, 2024, compared to $485.2 million for the three months ended March 31, 2023.

Proceeds from issuances of Common Stock, in connection with exercises of employee stock options, were $1.120 billion for the six months ended June 30, 2024, compared to $575.9 million for the six months ended June 30, 2023.

In addition, payments in connection with Common Stock tendered for employee tax obligations were $655.5 million for the six months ended June 30, 2024, compared to $113.1 million for the six months ended June 30, 2023.

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

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

As of March 31, 2024, $1.233 billion remained available for share repurchases under the program.

In April 2024, our board of directors authorized a 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 described above.

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

Six Months Ended

(In millions) 2024 2023

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Total cost of shares $ 899.4 $ 1,416.7

In April 2024, our board of directors authorized a new 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 described above.

As of June 30, 2024, an aggregate of $3.631 billion remained available for share repurchases under the programs.

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, 2023 (filed February 5, 2024).

There have been no material changes to critical accounting estimates during the three months ended March 31, 2024.

There have been no material changes to critical accounting estimates during the six months ended June 30, 2024.

Future Impact of Recently Issued Accounting Standards

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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-Q

Item 2. Management’s Discussion and Analysis