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Collaboration, License, and Other Agreements
 6 Months Ended
Jun. 30, 2022
Revenue from Contract with Customer [Abstract]  
Collaboration, License, and Other Agreements Collaboration, License, and Other Agreements
a. Sanofi
Amounts recognized in our Statements of Operations in connection with our collaborations with Sanofi are detailed below:
Statement of Operations ClassificationThree Months Ended
June 30,		Six Months Ended
June 30,
(In millions)2022202120222021
Antibody:
Regeneron's share of profits in connection with commercialization of antibodiesCollaboration revenue$496.6 $327.6 $911.9 $588.2 
Sales-based milestone earnedCollaboration revenue$— $— $50.0 $— 
Reimbursement for manufacturing of commercial suppliesCollaboration revenue$145.5 $110.9 $306.3 $216.5 
OtherCollaboration revenue$28.9 $— $28.9 $— 
Reimbursement of research and development expensesReduction of Research and development expense$52.7 $46.5 $89.2 $77.1 
Regeneron's obligation for its share of Sanofi research and development expensesResearch and development expense$(15.6)$(10.6)$(25.3)$(22.5)
Reimbursement of commercialization-related expenses Reduction of Selling, general, and administrative expense$110.8 $78.3 $202.5 $137.9 
Immuno-oncology:
Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United StatesCollaboration revenue$3.9 $(3.5)$6.7 $(9.6)
Reimbursement for manufacturing of ex-U.S. commercial suppliesCollaboration revenue$2.6 $2.7 $4.6 $7.4 
Reimbursement of research and development expensesReduction of Research and development expense$21.2 $22.5 $42.7 $44.4 
Reimbursement of commercialization-related expensesReduction of Selling, general, and administrative expense$22.4 $20.7 $41.4 $39.2 
Regeneron's obligation for its share of Sanofi commercial expensesSelling, general, and administrative expense$(10.7)$(10.9)$(19.9)$(18.6)
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profitsCost of goods sold$(37.8)$(34.4)$(70.1)$(64.8)
Amounts recognized in connection with up-front payments receivedOther operating income$17.0 $20.7 $35.1 $43.6 
Antibody
The Company is party to a global, strategic collaboration with Sanofi to research, develop, and commercialize fully human monoclonal antibodies (the "Antibody Collaboration"), which currently consists of Dupixent® (dupilumab), Kevzara® (sarilumab), and itepekimab.
Under the terms of the Antibody License and Collaboration Agreement, Sanofi is generally responsible for funding 80% to 100% of agreed-upon development costs. We are obligated to reimburse Sanofi for 30% to 50% of worldwide development expenses that were funded by Sanofi based on our share of collaboration profits from commercialization of collaboration products. Under the terms of the 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%.
Sanofi leads commercialization activities for products under the Antibody Collaboration, subject to the Company's right to co-commercialize such products. In addition to profit and loss sharing, the Company is entitled to receive sales milestone payments
from Sanofi. 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. 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.
The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
June 30,December 31,
(In millions)20222021
Accounts receivable, net $751.5 $504.8 
Deferred revenue
$457.5 $368.7 
Immuno-oncology
The Company has been party to a collaboration with Sanofi for antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties were co-developing and co-commercializing Libtayo. The parties shared equally, on an ongoing basis, development and commercialization expenses for Libtayo. The Company had principal control over the development of Libtayo and led commercialization activities in the United States (see Note 2 for related product sales information), while Sanofi led commercialization activities outside of the United States. The parties shared equally in profits and losses in connection with the commercialization of Libtayo.
Effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide under an Amended and Restated Immuno-oncology License and Collaboration Agreement with Sanofi (the "A&R IO LCA"). Consequently, in July 2022, the Company 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. The Company will also pay Sanofi an 11% royalty on net product sales of Libtayo through March 31, 2034. Amounts paid to Sanofi in connection with obtaining the worldwide rights to Libtayo, including the up-front payment and any contingent consideration, will be recorded as an intangible asset.
The Company was 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 A&R IO LCA, the amount of development costs incurred under the IO Collaboration for which we are obligated to reimburse Sanofi is $35.0 million, and the Company will reimburse Sanofi for such development costs by paying Sanofi a 0.5% royalty on net product sales of Libtayo until all such development costs have been reimbursed by Regeneron.
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
June 30,December 31,
(In millions)20222021
Accounts receivable, net
$12.4 $(22.5)
Deferred revenue
$33.8 $16.0 
Other liabilities
$241.0 $276.1 
Other liabilities include up-front payments received from Sanofi for which recognition had been deferred. During the third quarter of 2022, in connection with the A&R IO LCA, the remaining IO Collaboration Other liabilities balance will be recorded as a reduction to the intangible asset described above.
b. Bayer
The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA (aflibercept) and aflibercept 8 mg outside the United States. Agreed-upon development expenses incurred by the Company and Bayer are generally shared equally.
Bayer markets EYLEA outside the United States and the companies share equally in profits and losses from sales. In Japan, the Company was entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net product sales through 2021, and effective January 1, 2022, the companies share equally in profits and losses from sales.
Amounts recognized in our Statements of Operations in connection with our Bayer collaboration are as follows:
Statement of Operations ClassificationThree Months Ended
June 30,		Six Months Ended
June 30,
(In millions)2022202120222021
Regeneron's share of profits in connection with commercialization of EYLEA outside the United StatesCollaboration revenue$339.7 $335.4 $678.1 $644.3 
Reimbursement for manufacturing of ex-U.S. commercial suppliesCollaboration revenue$17.8 $13.7 $42.8 $27.6 
One-time payment in connection with change in Japan arrangement
Collaboration revenue$— $— $21.9 $— 
Reimbursement of research and development expenses
Reduction of Research and development expense
$9.8 

$9.9 $20.9 $20.7 
Regeneron's obligation for its share of Bayer research and development expenses
Research and development expense
$(6.9)$(10.9)$(17.7)$(23.4)
The following table summarizes contract balances in connection with our Bayer collaboration:
June 30,December 31,
(In millions)20222021
Accounts receivable, net$347.6 $355.5 
Deferred revenue
$133.7 $129.4 
c. U.S. Government
In 2020, we announced an expansion of our Other Transaction Agreement with the Biomedical Advanced Research Development Authority ("BARDA"), pursuant to which the U.S. Department of Health and Human Services ("HHS") was obligated to fund certain of our costs incurred for research and development activities related to COVID-19 treatments.
In 2020 and 2021, we entered into agreements to manufacture and deliver filled and finished drug product of REGEN-COV (casirivimab and imdevimab) to the U.S. government. In connection with one of our 2021 agreements, Roche supplied a portion of the doses to Regeneron to fulfill our agreement with the U.S. government (see "Roche" 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 its agreements with the U.S. government. See Note 2 for REGEN-COV net product sales recognized during the three and six months ended June 30, 2021.
d. Roche
In 2020, we entered into a collaboration agreement (the "Roche Collaboration Agreement") with Roche to develop, manufacture, and distribute the casirivimab and imdevimab antibody cocktail (known as REGEN-COV in the United States and Ronapreve™ in other countries). We lead global development activities for casirivimab and imdevimab, and the parties jointly fund certain studies.
Under the terms of the agreement, each party is obligated to dedicate a certain amount of manufacturing capacity to casirivimab and imdevimab each year. We distribute the product in the United States and Roche distributes the product outside of the United States. 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. 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 our Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
Statement of Operations ClassificationThree Months Ended
June 30,		Six Months Ended
June 30,
(In millions)2022202120222021
Global gross profit payment from Roche in connection with sales of RonapreveCollaboration revenue$8.2 $167.9 $224.5 $234.7 
Reimbursement of research and development expenses from Roche (recorded as a reduction of Research and development expense) was $41.0 million and $127.8 million for the three and six months ended June 30, 2021. Such amounts were not material for the three and six months ended June 30, 2022.
The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
June 30,December 31,
(In millions)20222021
Accrued expenses and other current liabilities$5.8 $268.8 
e. Alnylam
In 2018, the Company 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). The parties share equally, on an ongoing basis, development expenses for ALN-HSD.
In 2019, the parties 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. For each program, we provide Alnylam with a specified amount of funding at program initiation and at lead candidate designation. 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 such siRNA therapeutic (cemdisiran) and a fully human monoclonal antibody being developed by the Company (pozelimab), with the Company as the licensee. Under the C5 siRNA Co-Commercialization Collaboration Agreement, the parties share costs equally and under the License Agreement, the licensee is responsible for its own costs and expenses.
Amounts recognized in our Statements of Operations in connection with the Alnylam agreements described above were not material for the three and six months ended June 30, 2022 and 2021. In addition, contract balances in our Balance Sheets were not material as of June 30, 2022 and December 31, 2021.
f. CheckmateIn May 2022, the Company completed its acquisition of Checkmate Pharmaceuticals, Inc. (“Checkmate”) for a total equity value of approximately $250 million. The Company made an assessment as to whether the set of assets acquired constituted a business and should be accounted for as a business combination. Given that substantially all of the fair value of the gross assets acquired was concentrated in a single identifiable asset, vidutolimod, which is in clinical development for oncology, the transaction was accounted for as an asset acquisition. As a result of the acquisition, the Company recorded (i) a charge of $195.0 million to Acquired in-process research and development and (ii) net assets of $35.3 million, net of cash, related to the assets acquired (including deferred tax assets and investments) and liabilities assumed.