Form 8-K

8-K — REGENERON PHARMACEUTICALS, INC.

Accession: 0001104659-26-113895

Filed: 2026-10-06

Period: 2026-10-01

CIK: 0000872589

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Entry into a Material Definitive Agreement

Item: Results of Operations and Financial Condition

Item: Other Events

Documents

8-K — tm2627077d1_8k.htm (Primary)

XML — IDEA: XBRL DOCUMENT (R1.htm)

8-K — FORM 8-K

8-K (Primary)

Filename: tm2627077d1_8k.htm · Sequence: 1

false

0000872589

2026-10-01

iso4217:USD

xbrli:shares

iso4217:USD

xbrli:shares

UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant

to Section 13 or 15(d) of

the Securities

Exchange Act of 1934

Date

of Report (Date of earliest event reported): October

1, 2026

REGENERON

PHARMACEUTICALS, INC.

(Exact

name of registrant as specified in its charter)

New

York

(State

or other jurisdiction of incorporation)

000-19034

13-3444607

(Commission

File

Number)

(I.R.S.

Employer

Identification

No.)

777

Old Saw Mill River Road

Tarrytown,

New York

10591-6707

(Address

of principal executive offices)

(Zip

Code)

Registrant’s

telephone number, including area code: (914) 847-7000

Check the

appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any

of the following provisions (see General Instruction A.2. below):

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant

to Section 12(b) of the Act:

Title

of each class

Trading

Symbol(s)

Name

of each exchange on which registered

Common

Stock – par value $0.001 per share

REGN

The Nasdaq Global Select Market

Indicate by

check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405

of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ¨

If an emerging

growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any

new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

Item 1.01. Entry into a Material

Definitive Agreement.

On October

1, 2026, Regeneron Pharmaceuticals, Inc., a New York corporation (“Regeneron” or the “Company”),

Sanofi Biotechnology SAS, a société par actions simplifée organized under the laws of France (“Sanofi

Biotechnology”), and Sanofi, a société anonyme organized under the laws of France (“Sanofi Parent”

and, with Sanofi Biotechnology, “Sanofi”), entered into the Sixth Amendment to the Amended and Restated License and

Collaboration Agreement (the “Sixth Amendment”), which amends the Amended and Restated License and Collaboration Agreement,

dated as of November 10, 2009 (as amended), by and between the Company, Sanofi Biotechnology (as successor in interest to Aventis Pharmaceuticals

Inc.), and Sanofi Parent (the “Antibody LCA”). Pursuant to the Sixth Amendment, the parties have agreed to co-develop

and co-commercialize four new long-acting, Regeneron-invented antibodies: (i) an antibody targeting interleukin-13 (“IL-13”),

(ii) an antibody targeting interleukin-4 (“IL-4”), (iii) an antibody targeting IL-4 receptor alpha (IL-4Rα),

and (iv) a bispecific antibody targeting IL-4xIL-13 (each, a “New Licensed Product” and, collectively, the “New

Licensed Products”). Regeneron will also have the option, on an asset-by-asset basis after completion of certain ongoing clinical

trials, to include in the collaboration Sanofi’s Phase 2/3 asset lunsekimig, an investigational bispecific Nanobody®

VHH therapy targeting thymic stromal lymphopoietin (TSLP) and IL-13, and another Sanofi early development product. In the event

Regeneron exercises this option for any such product, it will reimburse Sanofi for certain development costs related to such product.

Pursuant

to the Sixth Amendment, Sanofi will make an upfront payment to Regeneron of $1.0 billion. In addition, the Sixth Amendment provides that

Regeneron will be entitled to receive up to an additional $7.0 billion of payments in the aggregate upon the achievement of certain development,

regulatory, and commercial milestones with respect to the New Licensed Products. Global profits realized on the sale of New Licensed

Products will be shared equally between Regeneron and Sanofi, as calculated under the Antibody LCA.

Pursuant

to the Sixth Amendment, the parties have agreed on an initial global development plan for the IL-13 asset and are to agree on an initial

global development plan for each of the other New Licensed Products. All development costs incurred with respect to all licensed products

under the Antibody LCA, including the New Licensed Products, will be shared equally by the parties. In addition, development costs in

excess of a budget cap for all New Licensed Products will be the responsibility of Regeneron, subject to certain rights to recoup such

excess costs in future years. Regeneron will be the lead development party and the lead regulatory party prior to the filing of an application

for marketing approval for each New Licensed Product. Regeneron will remain the lead regulatory party for applications for marketing

approval and further commercialization in the United States, and Sanofi will be the lead regulatory party for applications for marketing

approval and further commercialization outside the United States. Sanofi will be the lead party with respect to the commercialization

of the New Licensed Products.

The foregoing

description of the Sixth Amendment is qualified in its entirety by reference to the full text of the Sixth Amendment, a copy of which

will be filed with the U.S. Securities and Exchange Commission as an exhibit to the Quarterly Report on Form 10-Q to be filed by the

Company for the quarterly period ended September 30, 2026.

Item 2.02. Results of Operations and Financial Condition.

Regeneron

currently expects that its financial results calculated in accordance with U.S. generally accepted accounting principles (“GAAP”)

and its non-GAAP financial results for the third quarter 2026 will include an acquired in-process research and development (“IPR&D”)

charge of approximately $22 million on a pre-tax basis. The acquired IPR&D charge is expected to negatively impact each of GAAP and

non-GAAP net income per diluted share for the third quarter 2026 by approximately $0.18.

Acquired

IPR&D charges may include IPR&D acquired in connection with asset acquisitions as well as up-front, opt-in, and development milestone

payments and premiums paid on equity securities related to collaboration and licensing agreements. Regeneron does not forecast such

acquired IPR&D charges due to the uncertainty of the future occurrence, magnitude, and timing of these transactions in any given

period.

Regeneron’s

results for the third quarter 2026 have not been finalized and are subject to Regeneron’s financial statement closing procedures.

There can be no assurance that actual results will not differ from the preliminary (unaudited) estimates described herein.

The information

included in this Item 2.02 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934,

as amended, nor shall such information be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended,

except as shall be expressly set forth by specific reference in such a filing.

Item 8.01. Other Events.

In connection

with the execution of the Sixth Amendment, Regeneron and Sanofi entered into a settlement agreement pursuant to which Regeneron agreed

to dismiss its lawsuit concerning Sanofi’s obligation to provide Regeneron with full access to material information relating to

the commercialization of Dupixent® (dupilumab) and other products commercialized pursuant to the Antibody LCA, and Regeneron’s

audit rights under the Antibody LCA.

Note

Regarding Forward-Looking Statements

This

Current Report on Form 8-K (this “Report”) includes forward-looking statements that involve risks and uncertainties

relating to future events and the future performance of Regeneron, and actual events or results may differ materially from these forward-looking

statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,”

“seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking

statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and

uncertainties include, among others, the Company’s expectations with regard to the development and commercialization of the New

Licensed Products and the amounts to be received pursuant to the Sixth Amendment, as well as the Company’s expected acquired in-process

research and development charge for the quarterly period ended September 30, 2026 and its expected impact on GAAP and non-GAAP net income

per diluted share for this period, as discussed in this Report. A more complete description of these and other material risks can be

found in Regeneron’s filings with the U.S. Securities and Exchange Commission. Any forward-looking statements are made based on

management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron.

The Company does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including, without limitation,

any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Note Regarding Non-GAAP

Financial Measures

This

Report references non-GAAP net income per diluted share, which is a financial measure that is not calculated in accordance with U.S.

Generally Accepted Accounting Principles (“GAAP”). This non-GAAP financial measure is computed by excluding certain

non-cash and/or other items from the related GAAP financial measure. The Company also includes a non-GAAP adjustment for the estimated

income tax effect of reconciling items. The Company makes such adjustments for items the Company does not view as useful in evaluating

its operating performance. Management uses this and other non-GAAP measures for planning, budgeting, forecasting, assessing historical

performance, and making financial and operational decisions, and also provides forecasts to investors on this basis. Additionally, such

non-GAAP measures provide investors with an enhanced understanding of the financial performance of the Company's core business operations.

However, there are limitations in the use of such non-GAAP financial measures as they exclude certain expenses that are recurring in

nature. Furthermore, the Company's non-GAAP financial measures may not be comparable with non-GAAP information provided by other companies.

Any non-GAAP financial measure presented by Regeneron should be considered supplemental to, and not a substitute for, measures of financial

performance prepared in accordance with GAAP.

SIGNATURES

Pursuant

to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by

the undersigned hereunto duly authorized.

Date: October 6, 2026

REGENERON PHARMACEUTICALS, INC.

By:

/s/ Joseph J. LaRosa

Name:

Joseph J. LaRosa

Title:

Executive Vice President, General Counsel and Secretary

XML — IDEA: XBRL DOCUMENT

XML

Filename: R1.htm · Sequence: 6

v3.26.3

Cover

Oct. 01, 2026

Cover [Abstract]

Document Type

8-K

Amendment Flag

false

Document Period End Date

Oct. 01, 2026

Entity File Number

000-19034

Entity Registrant Name

REGENERON

PHARMACEUTICALS, INC.

Entity Central Index Key

0000872589

Entity Tax Identification Number

13-3444607

Entity Incorporation, State or Country Code

Entity Address, Address Line One

777

Old Saw Mill River Road

Entity Address, City or Town

Tarrytown

Entity Address, State or Province

Entity Address, Postal Zip Code

10591-6707

City Area Code

914

Local Phone Number

847-7000

Written Communications

false

Soliciting Material

false

Pre-commencement Tender Offer

false

Pre-commencement Issuer Tender Offer

false

Title of 12(b) Security

Common

Stock – par value $0.001 per share

Trading Symbol

REGN

Security Exchange Name

NASDAQ

Entity Emerging Growth Company

false

- Definition

Boolean flag that is true when the XBRL content amends previously-filed or accepted submission.

+ References

No definition available.

+ Details

Name:

dei_AmendmentFlag

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Area code of city

+ References

No definition available.

+ Details

Name:

dei_CityAreaCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Cover page.

+ References

No definition available.

+ Details

Name:

dei_CoverAbstract

Namespace Prefix:

dei_

Data Type:

xbrli:stringItemType

Balance Type:

Period Type:

duration

- Definition

For the EDGAR submission types of Form 8-K: the date of the report, the date of the earliest event reported; for the EDGAR submission types of Form N-1A: the filing date; for all other submission types: the end of the reporting or transition period. The format of the date is YYYY-MM-DD.

+ References

No definition available.

+ Details

Name:

dei_DocumentPeriodEndDate

Namespace Prefix:

dei_

Data Type:

xbrli:dateItemType

Balance Type:

Period Type:

duration

- Definition

The type of document being provided (such as 10-K, 10-Q, 485BPOS, etc). The document type is limited to the same value as the supporting SEC submission type, or the word 'Other'.

+ References

No definition available.

+ Details

Name:

dei_DocumentType

Namespace Prefix:

dei_

Data Type:

dei:submissionTypeItemType

Balance Type:

Period Type:

duration

- Definition

Address Line 1 such as Attn, Building Name, Street Name

+ References

No definition available.

+ Details

Name:

dei_EntityAddressAddressLine1

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the City or Town

+ References

No definition available.

+ Details

Name:

dei_EntityAddressCityOrTown

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Code for the postal or zip code

+ References

No definition available.

+ Details

Name:

dei_EntityAddressPostalZipCode

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Name of the state or province.

+ References

No definition available.

+ Details

Name:

dei_EntityAddressStateOrProvince

Namespace Prefix:

dei_

Data Type:

dei:stateOrProvinceItemType

Balance Type:

Period Type:

duration

- Definition

A unique 10-digit SEC-issued value to identify entities that have filed disclosures with the SEC. It is commonly abbreviated as CIK.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityCentralIndexKey

Namespace Prefix:

dei_

Data Type:

dei:centralIndexKeyItemType

Balance Type:

Period Type:

duration

- Definition

Indicate if registrant meets the emerging growth company criteria.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityEmergingGrowthCompany

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Commission file number. The field allows up to 17 characters. The prefix may contain 1-3 digits, the sequence number may contain 1-8 digits, the optional suffix may contain 1-4 characters, and the fields are separated with a hyphen.

+ References

No definition available.

+ Details

Name:

dei_EntityFileNumber

Namespace Prefix:

dei_

Data Type:

dei:fileNumberItemType

Balance Type:

Period Type:

duration

- Definition

Two-character EDGAR code representing the state or country of incorporation.

+ References

No definition available.

+ Details

Name:

dei_EntityIncorporationStateCountryCode

Namespace Prefix:

dei_

Data Type:

dei:edgarStateCountryItemType

Balance Type:

Period Type:

duration

- Definition

The exact name of the entity filing the report as specified in its charter, which is required by forms filed with the SEC.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityRegistrantName

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

The Tax Identification Number (TIN), also known as an Employer Identification Number (EIN), is a unique 9-digit value assigned by the IRS.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b-2

+ Details

Name:

dei_EntityTaxIdentificationNumber

Namespace Prefix:

dei_

Data Type:

dei:employerIdItemType

Balance Type:

Period Type:

duration

- Definition

Local phone number for entity.

+ References

No definition available.

+ Details

Name:

dei_LocalPhoneNumber

Namespace Prefix:

dei_

Data Type:

xbrli:normalizedStringItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 13e

-Subsection 4c

+ Details

Name:

dei_PreCommencementIssuerTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14d

-Subsection 2b

+ Details

Name:

dei_PreCommencementTenderOffer

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Title of a 12(b) registered security.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection b

+ Details

Name:

dei_Security12bTitle

Namespace Prefix:

dei_

Data Type:

dei:securityTitleItemType

Balance Type:

Period Type:

duration

- Definition

Name of the Exchange on which a security is registered.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 12

-Subsection d1-1

+ Details

Name:

dei_SecurityExchangeName

Namespace Prefix:

dei_

Data Type:

dei:edgarExchangeCodeItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as soliciting material pursuant to Rule 14a-12 under the Exchange Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Exchange Act

-Number 240

-Section 14a

-Subsection 12

+ Details

Name:

dei_SolicitingMaterial

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration

- Definition

Trading symbol of an instrument as listed on an exchange.

+ References

No definition available.

+ Details

Name:

dei_TradingSymbol

Namespace Prefix:

dei_

Data Type:

dei:tradingSymbolItemType

Balance Type:

Period Type:

duration

- Definition

Boolean flag that is true when the Form 8-K filing is intended to satisfy the filing obligation of the registrant as written communications pursuant to Rule 425 under the Securities Act.

+ References

Reference 1: http://www.xbrl.org/2003/role/presentationRef

-Publisher SEC

-Name Securities Act

-Number 230

-Section 425

+ Details

Name:

dei_WrittenCommunications

Namespace Prefix:

dei_

Data Type:

xbrli:booleanItemType

Balance Type:

Period Type:

duration