Collaboration, License, and Other Agreements

3 Months Ended

Mar. 31, 2024

Revenue from Contract with Customer [Abstract]

Collaboration, License, and Other Agreements

Collaboration, License, and Other Agreements

a. Sanofi

The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies, which currently consists of Dupixent® (dupilumab), Kevzara® (sarilumab), and itepekimab.

Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. The Company is obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi (i.e., "development balance") based on the Company's share of collaboration profits; however, the Company is only required to apply 20% of its share of profits from the collaboration each calendar quarter to reimburse Sanofi for these development expenses. As of March 31, 2024, the Company's contingent reimbursement obligation to Sanofi under the collaboration was approximately $2.200 billion.

Sanofi leads commercialization activities for products under the collaboration, subject to the Company's right to co-commercialize such products.

Amounts recognized in the Company's Statements of Operations in connection with its Sanofi collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's share of profits in connection with commercialization of antibodies	Collaboration revenue	$	804.0	$	636.5
Reimbursement for manufacturing of commercial supplies	Collaboration revenue	$	105.8	$	161.9
Regeneron's obligation for its share of Sanofi R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(18.6)	$	(26.4)
Reimbursement of commercialization-related expenses	Reduction of SG&A expense	$	139.5	$	117.6

The following table summarizes contract balances in connection with the Company's Sanofi collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accounts receivable, net	$	947.0	$	1,029.1
Deferred revenue	$	532.2	$	427.7

b. Bayer

The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA 8 mg (aflibercept 8 mg) and EYLEA (aflibercept) outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally. Within the United States, the Company is responsible for commercialization and retains profits from such sales. Bayer is responsible for commercialization activities outside the United States, and the companies share equally in profits from such sales.

Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's share of profits in connection with commercialization of EYLEA 8 mg and EYLEA outside the United States	Collaboration revenue	$	333.9	$	331.6
Reimbursement for manufacturing of ex-U.S. commercial supplies	Collaboration revenue	$	22.1	$	25.3
Regeneron's obligation for its share of Bayer R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(8.7)	$	(13.4)

The following table summarizes contract balances in connection with the Company's Bayer collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accounts receivable, net	$	359.0	$	381.7
Deferred revenue	$	151.1	$	138.2

c. Alnylam

The Company is party to a collaboration agreement with Alnylam Pharmaceuticals, Inc. to discover, develop, and commercialize RNA interference therapeutics for a broad range of diseases by addressing therapeutic disease targets expressed in the eye and central nervous system, in addition to a select number of targets expressed in the liver. For each program, the Company provides Alnylam with a specified amount of funding at program initiation and at lead candidate designation. 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 or license agreement.

Amounts recognized in the Company's Statements of Operations in connection with its Alnylam collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Regeneron's obligation for its share of Alnylam R&D expenses, net of reimbursement of R&D expenses	(R&D expense)	$	(17.5)	$	(21.3)

The following table summarizes contract balances in connection with the Company's Alnylam collaboration:

	March 31,		December 31,
(In millions)	2024		2023
Accrued expenses and other current liabilities	$	18.9	$	22.6

d. Roche

The Company is a party to 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 collaboration agreement, the parties jointly fund certain studies, and the Company has the right to distribute the product in the United States while Roche has the right to distribute the product outside 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.

Amounts recognized in the Company's Statements of Operations in connection with its Roche collaboration are as follows:

	Statement of Operations Classification	Three Months Ended March 31,
(In millions)		2024		2023
Global gross profit payment from Roche in connection with sales of Ronapreve	Collaboration revenue	$	0.5	$	222.2

Reimbursement of research and development expenses from Roche was not material for the three months ended March 31, 2024 and 2023.

Contract balances in the Company's Balance Sheets in connection with the Roche collaboration were not material as of March 31, 2024 and December 31, 2023.

e. Sonoma

In March 2023, the Company and Sonoma Biotherapeutics, Inc. entered into a license and collaboration agreement to bring together the Company's VelociSuite® technologies with Sonoma's technology platform for the discovery, development, and commercialization of novel regulatory T cell ("Treg") therapies for autoimmune diseases. In connection with the agreement, the Company made a $45.0 million up-front payment (which was recorded to Acquired in-process research and development expense in the first quarter of 2023) and, in April 2023, the Company purchased an aggregate of $30.0 million of Sonoma preferred stock. Sonoma is also eligible to receive a $45.0 million development milestone payment. The parties co-fund research and development activities under the collaboration.

Amounts recognized in the Company's Statements of Operations in connection with research and development activities co-funded under the Sonoma collaboration were not material for the three months ended March 31, 2024. In addition, contract balances in the Company's Balance Sheets in connection with the Sonoma collaboration were not material as of March 31, 2024 and December 31, 2023.