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Collaboration, License, and Other Agreements | 9 Months Ended
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Sep. 30, 2021
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 Classification |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2021 |  | 2020 |  | 2021 |  | 2020
Antibody: |  |  |  |  |  |  |  |  |  |
Regeneron's share of profits in connection with commercialization of antibodies |  | Collaboration revenue |  | $ | 387.0 |  |  | $ | 212.8 |  |  | $ | 975.2 |  |  | $ | 555.6 |
Sales-based milestone earned |  | Collaboration revenue |  | $ | 50.0 |  |  | $ | 50.0 |  |  | $ | 50.0 |  |  | $ | 50.0 |
Reimbursement for manufacturing of commercial supplies |  | Collaboration revenue |  | $ | 144.7 |  |  | $ | 94.3 |  |  | $ | 361.2 |  |  | $ | 275.0 |
Reimbursement of research and development expenses |  | Reduction of Research and development expense |  | $ | 45.2 |  |  | $ | 45.5 |  |  | $ | 122.3 |  |  | $ | 174.4 |
Regeneron's obligation for its share of Sanofi research and development expenses |  | Research and development expense |  | $ | (10.3) |  |  | $ | (17.5) |  |  | $ | (32.8) |  |  | $ | (59.1) |
Reimbursement of commercialization-related expenses |  | Reduction of Selling, general, and administrative expense |  | $ | 79.0 |  |  | $ | 83.2 |  |  | $ | 216.9 |  |  | $ | 260.4 |
Immuno-oncology: |  |  |  |  |  |  |  |  |  |
Regeneron's share of losses in connection with commercialization of Libtayo outside the United States |  | Collaboration revenue |  | $ | (3.0) |  |  | $ | (4.7) |  |  | $ | (12.6) |  |  | $ | (17.3) |
Reimbursement for manufacturing of commercial supplies |  | Collaboration revenue |  | $ | 3.1 |  |  | $ | 0.9 |  |  | $ | 10.5 |  |  | $ | 6.0 |
Reimbursement of research and development expenses |  | Reduction of Research and development expense |  | $ | 21.8 |  |  | $ | 49.8 |  |  | $ | 66.2 |  |  | $ | 136.7 |
Reimbursement of commercialization-related expenses |  | Reduction of Selling, general, and administrative expense |  | $ | 22.8 |  |  | $ | 14.5 |  |  | $ | 62.0 |  |  | $ | 39.2 |
Regeneron's obligation for its share of Sanofi commercial expenses |  | Selling, general, and administrative expense |  | $ | (9.4) |  |  | $ | (6.1) |  |  | $ | (28.0) |  |  | $ | (15.0) |
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits |  | Cost of goods sold |  | $ | (34.6) |  |  | $ | (31.5) |  |  | $ | (99.4) |  |  | $ | (86.5) |
Amounts recognized in connection with up-front payments received |  | Other operating income |  | $ | (47.7) |  |  | $ | 20.0 |  |  | $ | (4.1) |  |  | $ | 57.0 |
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 ("LCA"), Sanofi is generally responsible for funding 80%–100% of agreed-upon development costs. 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. In the third quarter of 2020, the Company earned, and recognized as revenue, the first $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.0 billion on a rolling twelve-month basis. In the third quarter of 2021, the Company earned, and recognized as revenue, the second $50.0 million sales-based milestone from Sanofi, upon aggregate annual sales of antibodies outside the United States (including Praluent) exceeding $1.5 billion on a rolling twelve-month basis. We are entitled to receive up to an aggregate of $150.0 million in additional sales milestone payments from Sanofi. The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
|  | September 30, |  | December 31,
(In millions) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 536.0 |  |  | $ | 407.7 |
Deferred revenue |  | $ | 431.7 |  |  | $ | 347.7 |
In April 2020, the Company and Sanofi entered into an amendment to the LCA in connection with, among other things, the removal of Praluent from the LCA such that (i) effective April 1, 2020, the LCA no longer governs the development, manufacture, or commercialization of Praluent and (ii) the quarterly period ended March 31, 2020 was the last quarter for which Sanofi and the Company shared profits and losses for Praluent under the LCA. The parties also entered into a Praluent Cross License & Commercialization Agreement (the "Praluent Agreement") pursuant to which, effective April 1, 2020, the Company, at its sole cost, became solely responsible for the development and commercialization of Praluent in the United States, and Sanofi, at its sole cost, became solely responsible for the development and commercialization of Praluent outside of the United States. Under the Praluent Agreement, Sanofi will pay the Company a 5% royalty on Sanofi’s net product sales of Praluent outside the United States until March 31, 2032. The Company will not owe Sanofi royalties on the Company’s net product sales of Praluent in the United States. Although each party will be responsible for manufacturing Praluent for its respective territory, the parties have entered into definitive supply agreements under which, for a certain transitional period, the Company will continue to supply drug substance to Sanofi and Sanofi will continue to supply finished product to Regeneron. With respect to any intellectual property or product liability litigation relating to Praluent, the parties have agreed that, effective April 1, 2020, Regeneron and Sanofi each will be solely responsible for any such litigation (including damages and other costs and expenses thereof) in the United States and outside the United States, respectively, arising out of Praluent sales or other activities on or after April 1, 2020 (subject to Sanofi's right to set off a portion of any third-party royalty payments resulting from certain patent litigation proceedings against up to 50% of any Praluent royalty payment owed to Regeneron). The parties will each bear 50% of any damages arising out of Praluent sales or other activities prior to April 1, 2020. See Note 12 for discussion of legal proceedings related to Praluent. Immuno-Oncology The Company is party to a collaboration with Sanofi to research, develop, and commercialize antibody-based cancer treatments in the field of immuno-oncology (the "IO Collaboration"). Effective December 31, 2018, the Company and Sanofi entered into an Amended and Restated Immuno-oncology Discovery and Development Agreement ("Amended IO Discovery Agreement"), which narrowed the scope of the existing discovery and development activities conducted by the Company under the 2015 IO Discovery Agreement to developing therapeutic bispecific antibodies targeting (i) BCMA and CD3 (the "BCMAxCD3 Program") and (ii) MUC16 and CD3 (the "MUC16xCD3 Program") through clinical proof-of-concept. During the first quarter of 2021, Sanofi did not exercise its options to license rights to these product candidates; as a result, we retain the exclusive right to develop and commercialize such product candidates and Sanofi will receive a royalty on sales (if any). In addition, the Company has no further obligations to develop drug product candidates under the Amended IO Discovery Agreement. Under the terms of the Immuno-oncology License and Collaboration Agreement, the parties are co-developing and co-commercializing Libtayo (cemiplimab). The parties share equally, on an ongoing basis, agreed-upon development and commercialization expenses for Libtayo. The Company has principal control over the development of Libtayo and leads commercialization activities in the United States (see Note 2 for related product sales information), while Sanofi leads commercialization activities outside of the United States. The parties share equally in profits and losses in connection with the commercialization of Libtayo. During the three months ended September 30, 2021, we updated our estimate of the total research and development costs expected to be incurred (which resulted in a change to the estimate of the stage of completion) in connection with the IO Collaboration, and, as a result, recorded a cumulative catch-up adjustment of $66.9 million as a reduction to other operating income. The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
|  | September 30, |  | December 31,
(In millions) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 0.1 |  |  | $ | (6.5) |
Deferred revenue |  | $ | 16.2 |  |  | $ | 10.7 |
Other liabilities |  | $ | 286.0 |  |  | $ | 280.9 |
Other liabilities include up-front payments received from Sanofi for which recognition has been deferred. The aggregate amount of the estimated consideration under the IO Collaboration related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of September 30, 2021 was $591.4 million. This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities. b. Bayer The Company is party to a license and collaboration agreement with Bayer for the global development and commercialization of EYLEA outside the United States. All agreed upon EYLEA development expenses incurred by the Company and Bayer are shared equally. Bayer markets EYLEA outside the United States, where, for countries other than Japan, the companies share equally in profits and losses from sales of EYLEA. In Japan, the Company is currently entitled to receive a tiered percentage of between 33.5% and 40.0% of EYLEA net product sales through 2021, and thereafter, the companies will share equally in profits and losses from sales of EYLEA. Amounts recognized in our Statements of Operations in connection with our Bayer EYLEA collaboration are as follows:
|  | Statement of Operations Classification |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2021 |  | 2020 |  | 2021 |  | 2020
Regeneron's net profit in connection with commercialization of EYLEA outside the United States |  | Collaboration revenue |  | $ | 351.0 |  |  | $ | 287.9 |  |  | $ | 995.3 |  |  | $ | 772.6 |
Reimbursement for manufacturing of commercial supplies |  | Collaboration revenue |  | $ | 14.0 |  |  | $ | 12.0 |  |  | $ | 41.6 |  |  | $ | 52.9 |
Reimbursement of research and development expenses |  | Reduction of Research and development expense |  | $ | 14.5 |  |  | $ | 11.5 |  |  | $ | 35.2 |  |  | $ | 34.3 |
Regeneron's obligation for its share of Bayer research and development expenses |  | Research and development expense |  | $ | (8.0) |  |  | $ | (12.9) |  |  | $ | (31.4) |  |  | $ | (26.3) |
The following table summarizes contract balances in connection with our Bayer EYLEA collaboration:
|  | September 30, |  | December 31,
(In millions) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 374.8 |  |  | $ | 336.2 |
Deferred revenue |  | $ | 115.2 |  |  | $ | 99.7 |
c. Teva The Company and Teva are parties to a collaboration agreement (the "Teva Collaboration Agreement") to develop and commercialize fasinumab globally, excluding certain Asian countries that are subject to our collaboration agreement with Mitsubishi Tanabe Pharma Corporation. The Company leads global development activities, and the parties share development costs equally, on an ongoing basis, under a global development plan. Amounts recognized in our Statements of Operations in connection with our collaboration with Teva are as follows:
|  | Statement of Operations Classification |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2021 |  | 2020 |  | 2021 |  | 2020
Reimbursement of research and development expenses |  | Reduction of Research and development expense |  | $ | 5.1 |  |  | $ | 25.9 |  |  | $ | 36.6 |  |  | $ | 82.1 |
Amounts recognized in connection with up-front and development milestone payments received |  | Other operating income |  | $ | 3.2 |  |  | $ | 17.2 |  |  | $ | 22.6 |  |  | $ | 54.5 |
The following table summarizes contract balances in connection with the Teva Collaboration Agreement:
|  | September 30, |  | December 31,
(In millions) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 5.2 |  |  | $ | 27.7 |
Other liabilities |  | $ | 43.3 |  |  | $ | 66.8 |
Other liabilities include up-front and development milestone payments received from Teva for which recognition has been deferred. The aggregate amount of the estimated consideration under the Teva Collaboration Agreement related to the Company's obligation that was unsatisfied (or partially unsatisfied) as of September 30, 2021 was $96.7 million. This amount is expected to be recognized over the remaining period in which the Company is obligated to satisfy its obligation in connection with performing development activities. d. U.S. Government REGEN-COV (casirivimab and imdevimab) In the first quarter of 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 July 2020, we entered into an agreement with entities acting at the direction of BARDA and the U.S. Department of Defense to manufacture and deliver filled and finished drug product of REGEN-COV to the U.S. government. In January 2021, the Company announced an agreement with an entity acting on behalf of the U.S. Department of Defense and HHS to manufacture and deliver additional filled and finished drug product of REGEN-COV to the U.S. government. Pursuant to the agreement, the U.S. government was obligated to purchase the 1.25 million doses of drug product that we delivered by June 30, 2021. The Company has completed its final deliveries of drug product under the agreements described above. In September 2021, the Company announced an amendment to its January 2021 agreement to supply the U.S. government with an additional 1.4 million doses of REGEN-COV. Pursuant to the agreement, the U.S. government is obligated to purchase all filled and finished doses of such additional drug product delivered by January 31, 2022, resulting in payments to the Company of up to $2.940 billion in the aggregate. Additionally, Roche will supply 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). See Note 2 for REGEN-COV net product sales recognized in connection with these agreements. e. Roche In August 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 ongoing studies, as well as any mutually agreed additional new global studies to evaluate further the potential of casirivimab and imdevimab in treating or preventing COVID-19. 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 Classification |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2021 |  | 2020 |  | 2021 |  | 2020
Global gross profit true-up payment owed from Roche in connection with sales of casirivimab and imdevimab |  | Collaboration revenue |  | $ | 127.1 |  |  | — |  |  | $ | 361.8 |  |  | — |
Reimbursement of research and development expenses |  | Reduction of Research and development expense |  | $ | 10.5 |  |  | $ | 9.5 |  |  | $ | 138.3 |  |  | $ | 9.5 |
The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
|  | September 30, |  | December 31,
(In millions) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 305.5 |  |  | $ | 77.1 |
f. Intellia 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. The parties collaborate to conduct research for the discovery, development, and commercialization of new therapies, in addition to the research and technology development of the CRISPR/Cas9 platform. In May 2020, we expanded our existing collaboration with Intellia to provide us with rights to develop products for additional in vivo CRISPR/Cas9-based therapeutic targets and for the parties to jointly develop potential products for the treatment of hemophilia A and B. In addition, we also received non-exclusive rights to independently develop and commercialize ex vivo gene edited products. In connection with the agreement, we made a $70.0 million up-front payment and purchased shares of Intellia common stock for an aggregate purchase price of $30.0 million. The up-front payment and the amount paid in excess of the fair market value of the shares purchased, or $15.0 million, were recorded to Research and development expense during the three months ended June 30, 2020.

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- Definition The entire disclosure for collaborative arrangements in which the entity is a participant, including a) information about the nature and purpose of such arrangements; b) its rights and obligations thereunder; c) the accounting policy for collaborative arrangements; and d) the income statement classification and amounts attributable to transactions arising from the collaborative arrangement between participants. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (a) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 2: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -SubTopic 10 -Section 50 -Paragraph 1 -Subparagraph (b) -URI http://asc.fasb.org/extlink&oid=6931272&loc=SL5834143-161434 Reference 3: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 808 -URI http://asc.fasb.org/topic&trid=5833765 + Details
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