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Collaboration, License, and Other Agreements (Tables) | 9 Months Ended
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Sep. 30, 2022
Revenue from Contract with Customer [Abstract] |
Schedule of collaborative revenue | Net product sales consist of the following:
|  |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2022 |  | 2021 |  | 2022 |  | 2021
EYLEA® | U.S. |  | $ | 1,629.4 |  |  | $ | 1,473.4 |  |  | $ | 4,768.2 |  |  | $ | 4,245.1 |
Libtayo®(a) | U.S. |  | 94.7 |  |  | 78.4 |  |  | 264.5 |  |  | 225.5 |
| ROW(b) |  | 31.0 |  |  | — |  |  | 31.0 |  |  | — |
Praluent® | U.S. |  | 29.7 |  |  | 44.8 |  |  | 94.5 |  |  | 130.0 |
REGEN-COV®(c) | U.S. |  | — |  |  | 676.7 |  |  | — |  |  | 3,530.1 |
Evkeeza® | U.S. |  | 13.6 |  |  | 6.6 |  |  | 33.2 |  |  | 9.1 |
Inmazeb® | U.S. |  | 3.0 |  |  | — |  |  | 3.0 |  |  | — |
ARCALYST®(d) | U.S. |  | — |  |  | — |  |  | — |  |  | 2.2 |
|  |  | $ | 1,801.4 |  |  | $ | 2,279.9 |  |  | $ | 5,194.4 |  |  | $ | 8,142.0 |
(a) Prior to July 1, 2022, Regeneron recorded net product sales of Libtayo in the United States and Sanofi recorded net product sales of Libtayo outside the United States. Effective July 1, 2022, the Company began recording net product sales of Libtayo outside the United States. See Note 3 for further details.
(b) Rest of world ("ROW")
(c) Net product sales of REGEN-COV in the United States relate to product sold in connection with our agreements with the U.S. government. See Note 3 for further details.
(d) Effective April 1, 2021, Kiniksa records net product sales of ARCALYST in the United States. Previously, the Company recorded net product sales of ARCALYST in the United States.
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) |  |  | 2022 |  | 2021 |  | 2022 |  | 2021
Antibody: |  |  |  |  |  |  |  |  |  |
Regeneron's share of profits in connection with commercialization of antibodies |  | Collaboration revenue |  | $ | 551.1 | * |  | $ | 387.0 |  |  | $ | 1,463.0 | * |  | $ | 975.2 |
Sales-based milestone earned |  | Collaboration revenue |  | $ | — |  |  | $ | 50.0 |  |  | $ | 50.0 |  |  | $ | 50.0 |
Reimbursement for manufacturing of commercial supplies |  | Collaboration revenue |  | $ | 160.5 |  |  | $ | 144.7 |  |  | $ | 466.8 |  |  | $ | 361.2 |
Other |  | Collaboration revenue |  | $ | (0.2) |  |  | $ | — |  |  | $ | 28.7 |  |  | $ | — |
(Regeneron's obligation for its share of Sanofi R&D expenses)/reimbursements of R&D expenses, net |  | (R&D expense)/reduction of R&D expense |  | $ | (4.3) |  |  | $ | 34.9 |  |  | $ | 59.6 |  |  | $ | 89.5 |
Reimbursement of commercialization-related expenses |  | Reduction of SG&A expense |  | $ | 108.6 |  |  | $ | 79.0 |  |  | $ | 311.1 |  |  | $ | 216.9 |
Immuno-oncology: |  |  |  |  |  |  |  |  |  |
Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States |  | Collaboration revenue |  | $ | — |  |  | $ | (3.0) |  |  | $ | 6.7 |  |  | $ | (12.6) |
Reimbursement for manufacturing of ex-U.S. commercial supplies |  | Collaboration revenue |  | $ | — |  |  | $ | 3.1 |  |  | $ | 4.6 |  |  | $ | 10.5 |
Reimbursement of R&D expenses |  | Reduction of R&D expense |  | $ | — |  |  | $ | 21.8 |  |  | $ | 42.7 |  |  | $ | 66.2 |
Reimbursement of commercialization-related expenses |  | Reduction of SG&A expense |  | $ | — |  |  | $ | 22.8 |  |  | $ | 41.4 |  |  | $ | 62.0 |
Regeneron's obligation for its share of Sanofi commercial expenses |  | SG&A expense |  | $ | — |  |  | $ | (9.4) |  |  | $ | (19.9) |  |  | $ | (28.0) |
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits |  | Cost of goods sold |  | $ | — |  |  | $ | (34.6) |  |  | $ | (70.1) |  |  | $ | (99.4) |
Amounts recognized in connection with up-front payments received |  | Other operating income |  | $ | — |  |  | $ | (47.7) |  |  | $ | 35.1 |  |  | $ | (4.1) |
* Net of one-time payment of $56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement described below
Amounts recognized in our Statements of Operations in connection with our Bayer collaboration are as follows:
|  | Statement of Operations Classification |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
(In millions) |  |  | 2022 |  | 2021 |  | 2022 |  | 2021
Regeneron's share of profits in connection with commercialization of EYLEA outside the United States |  | Collaboration revenue |  | $ | 315.3 |  |  | $ | 351.0 |  |  | $ | 993.4 |  |  | $ | 995.3 |
Reimbursement for manufacturing of ex-U.S. commercial supplies |  | Collaboration revenue |  | $ | 17.5 |  |  | $ | 14.0 |  |  | $ | 60.3 |  |  | $ | 41.6 |
One-time payment in connection with change in Japan arrangement |  | Collaboration revenue |  | $ | — |  |  | $ | — |  |  | $ | 21.9 |  |  | $ | — |
Reimbursement of R&D expenses |  | Reduction of R&D expense |  | $ | 11.8 |  |  | $ | 14.5 |  |  | $ | 32.7 |  |  | $ | 35.2 |
Regeneron's obligation for its share of Bayer research and development expenses |  | R&D expense |  | $ | (4.7) |  |  | $ | (8.0) |  |  | $ | (22.4) |  |  | $ | (31.4) |
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) |  |  | 2022 |  | 2021 |  | 2022 |  | 2021
Global gross profit payment from Roche in connection with sales of Ronapreve |  | Collaboration revenue |  | $ | 6.4 |  |  | $ | 127.1 |  |  | $ | 230.9 |  |  | $ | 361.8 |
Schedule of accounts receivable and deferred revenue information | The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
|  | September 30, |  | December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 770.0 |  |  | $ | 504.8 |
Deferred revenue |  | $ | 476.2 |  |  | $ | 368.7 |
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
|  | September 30, |  | December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 3.6 |  |  | $ | (22.5) |
Deferred revenue |  | $ | — |  |  | $ | 16.0 |
Other liabilities |  | $ | — |  |  | $ | 276.1 |
The following table summarizes contract balances in connection with our Bayer collaboration:
|  | September 30, |  | December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 323.0 |  |  | $ | 355.5 |
Deferred revenue |  | $ | 131.1 |  |  | $ | 129.4 |
The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
|  | September 30, |  | December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 3.2 |  |  | $ | — |
Accrued expenses and other current liabilities |  | $ | — |  |  | $ | 268.8 |

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