XML 41 R29.htm IDEA: XBRL DOCUMENT
v3.22.4

Collaboration, License, and Other Agreements (Tables) | 12 Months Ended
--- | ---
Dec. 31, 2022
Revenue from Contract with Customer [Abstract] |
Schedule of collaboration revenue | Net product sales consist of the following:
|  |  | Year Ended December 31,
(In millions) |  |  | 2022 |  | 2021 |  | 2020
EYLEA® | U.S. |  | $ | 6,264.6 |  |  | $ | 5,792.3 |  |  | $ | 4,947.2 |
Libtayo®(a) | U.S. |  | 374.5 |  |  | 306.3 |  |  | 270.7 |
| ROW(b) |  | 73.0 |  |  | — |  |  | —
Praluent®(c) | U.S. |  | 130.0 |  |  | 170.0 |  |  | 150.9
REGEN-COV®(d) | U.S. |  | — |  |  | 5,828.0 |  |  | 185.7 |
Evkeeza® | U.S. |  | 48.6 |  |  | 18.4 |  |  | — |
Inmazeb® | U.S. |  | 3.0 |  |  | — |  |  | — |
ARCALYST®(e) | U.S. |  | — |  |  | 2.2 |  |  | 13.1 |
|  |  | $ | 6,893.7 |  |  | $ | 12,117.2 |  |  | $ | 5,567.6 |
(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 records global net product sales of Libtayo. See Note 3 for further details.
(b) Rest of world ("ROW")
(c) Effective April 1, 2020, the Company became solely responsible for the development and commercialization of Praluent in the United States and records net product sales of Praluent in the United States. Previously, Sanofi recorded net product sales of Praluent in the United States. See Note 3 for further details.
(d) Net product sales of REGEN-COV in the United States relate to product sold in connection with the Company's agreements with the U.S. government. See Note 3 for further details.
(e) 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 the Company's Statements of Operations in connection with its collaborations with Sanofi are detailed below:
|  | Statement of Operations Classification |  | Year Ended December 31,
(In millions) |  |  | 2022 |  | 2021 |  | 2020
Antibody: |  |  |  |  |  |  |  |
Regeneron's share of profits in connection with commercialization of antibodies |  | Sanofi collaboration revenue |  | $ | 2,082.0 | * |  | $ | 1,363.0 |  |  | $ | 785.2 |
Sales-based milestones earned |  | Sanofi collaboration revenue |  | $ | 100.0 |  |  | $ | 50.0 |  |  | $ | 50.0 |
Reimbursement for manufacturing of commercial supplies |  | Sanofi collaboration revenue |  | $ | 633.7 |  |  | $ | 488.8 |  |  | $ | 368.0 |
Other |  | Sanofi collaboration revenue |  | $ | 28.7 |  |  | $ | — |  |  | $ | — |
Reimbursements of R&D expenses, net of Regeneron's obligation for its share of Sanofi R&D expenses |  | Reduction of R&D expense |  | $ | 43.0 |  |  | $ | 129.2 |  |  | $ | 149.1 |
Reimbursement of commercialization-related expenses |  | Reduction of SG&A expense |  | $ | 437.4 |  |  | $ | 320.5 |  |  | $ | 359.4 |
Immuno-oncology**: |  |  |  |  |  |  |  |
Regeneron's share of profits (losses) in connection with commercialization of Libtayo outside the United States |  | Sanofi collaboration revenue |  | $ | 6.7 |  |  | $ | (13.6) |  |  | $ | (25.7) |
Reimbursement for manufacturing of ex-U.S. commercial supplies |  | Sanofi collaboration revenue |  | $ | 4.6 |  |  | $ | 14.0 |  |  | $ | 8.9 |
Reimbursement of R&D expenses |  | Reduction of R&D expense |  | $ | 42.7 |  |  | $ | 85.1 |  |  | $ | 166.2 |
Reimbursement of commercialization-related expenses |  | Reduction of SG&A expense |  | $ | 41.4 |  |  | $ | 89.6 |  |  | $ | 64.7 |
Regeneron's obligation for its share of Sanofi commercial expenses |  | SG&A expense |  | $ | (19.9) |  |  | $ | (36.3) |  |  | $ | (22.4) |
Regeneron's obligation for Sanofi's share of Libtayo U.S. gross profits |  | Cost of goods sold |  | $ | (70.1) |  |  | $ | (133.0) |  |  | $ | (119.1) |
Amounts recognized in connection with up-front payments received |  | Other operating income |  | $ | 35.1 |  |  | $ | 6.1 |  |  | $ | 210.6 |
* Net of one-time payment of $56.9 million to Sanofi in connection with the amendment to the Antibody License and Collaboration Agreement
** As described within the "Immuno-Oncology" section below, effective July 1, 2022, the Company obtained the exclusive right to develop, commercialize, and manufacture Libtayo worldwide
Amounts recognized in the Company's Statements of Operations in connection with its Bayer collaboration are as follows:
|  | Statement of Operations Classification |  | Year Ended December 31,
(In millions) |  |  | 2022 |  | 2021 |  | 2020
Regeneron's share of profits in connection with commercialization of EYLEA outside the United States |  | Other collaboration revenue |  | $ | 1,317.4 |  |  | $ | 1,349.2 |  |  | $ | 1,107.9 |
Reimbursement for manufacturing of ex-U.S. commercial supplies |  | Other collaboration revenue |  | $ | 91.4 |  |  | $ | 60.1 |  |  | $ | 78.2 |
One-time payment in connection with change in Japan arrangement |  | Other collaboration revenue |  | $ | 21.9 |  |  | $ | — |  |  | $ | — |
Reimbursement of R&D expenses |  | Reduction of R&D expense |  | $ | 51.0 |  |  | $ | 46.1 |  |  | $ | 46.7 |
Regeneron's obligation for its share of Bayer R&D expenses |  | R&D expense |  | $ | (34.3) |  |  | $ | (40.9) |  |  | $ | (35.8) |
Amounts recognized in the Company's Statements of Operations in connection with the Roche Collaboration Agreement are as follows:
|  | Statement of Operations Classification |  | Year Ended December 31,
(In millions) |  |  | 2022 |  | 2021 |  | 2020
Global gross profit payment from Roche in connection with sales of REGEN-COV and Ronapreve |  | Other collaboration revenue |  | $ | 627.3 |  |  | $ | 361.8 |  |  | $ | — |
Reimbursement of R&D expenses |  | Reduction of R&D expense |  | $ | 6.8 |  |  | $ | 128.1 |  |  | $ | 78.5 |
Global gross profit payment to Roche in connection with sales of REGEN-COV and Ronapreve |  | Cost of goods sold |  | $ | — |  |  | $ | 259.6 |  |  | $ | — |
Amounts recognized in the Company's Statements of Operations in connection with the Teva Collaboration Agreement are as follows:
|  | Statement of Operations Classification |  | Year Ended December 31,
(In millions) |  |  | 2022 |  | 2021 |  | 2020
Amounts recognized in connection with up-front and development milestone payments received |  | Other operating income |  | $ | 33.3 |  |  | $ | 26.2 |  |  | $ | 47.2 |
In addition, the Company recognized reimbursement of R&D expenses (as a reduction of R&D expense) of $42.4 million and $109.4 million for the years ended December 31, 2021 and 2020, respectively. Such amount was not material for the year ended December 31, 2022.
Schedule of accounts receivable and deferred revenue information | The following table summarizes contract balances in connection with the Company's Antibody Collaboration with Sanofi:
|  | As of December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 692.3 |  |  | $ | 504.8 |
Deferred revenue |  | $ | 415.8 |  |  | $ | 368.7 |
The following table summarizes contract balances in connection with the Company's IO Collaboration with Sanofi:
|  | As of December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | — |  |  | $ | (22.5) |
Deferred revenue |  | $ | — |  |  | $ | 16.0 |
Other liabilities |  | $ | — |  |  | $ | 276.1 |
The following table summarizes contract balances in connection with the Company's Bayer collaboration:
|  | As of December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 348.2 |  |  | $ | 355.5 |
Deferred revenue |  | $ | 131.9 |  |  | $ | 129.4 |
The following table summarizes contract balances in connection with the Roche Collaboration Agreement:
|  | As of December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 396.6 |  |  | $ | — |
Accrued expenses and other current liabilities |  | $ | — |  |  | $ | 268.8 |
The following table summarizes contract balances in connection with the Teva Collaboration Agreement:
|  | As of December 31,
(In millions) |  | 2022 |  | 2021
Accounts receivable, net |  | $ | 1.6 |  |  | $ | 11.0 |
Other liabilities |  | $ | — |  |  | $ | 39.7 |
Other liabilities included up-front and development milestone payments received from Teva for which recognition had been deferred. During 2022, the Company discontinued further clinical development of fasinumab and, as a result, recorded $31.9 million as an increase to Other operating income as the Company deemed its obligation to provide development services in connection with the Teva Collaboration Agreement to be complete.

X
- Definition Tabular disclosure of receivable, contract asset, and contract liability from contract with customer. Includes, but is not limited to, change in contract asset and contract liability. + References Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 10 -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130551-203045 + Details
Name: | us-gaap_ContractWithCustomerAssetAndLiabilityTableTextBlock
Namespace Prefix: | us-gaap_
Data Type: | dtr-types:textBlockItemType
Balance Type: | na
Period Type: | duration

X
- Definition Tabular disclosure of disaggregation of revenue into categories depicting how nature, amount, timing, and uncertainty of revenue and cash flows are affected by economic factor. + References Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Publisher FASB -Name Accounting Standards Codification -Topic 606 -SubTopic 10 -Section 50 -Paragraph 5 -URI https://asc.fasb.org/extlink&oid=126920106&loc=SL49130545-203045 + Details
Name: | us-gaap_DisaggregationOfRevenueTableTextBlock
Namespace Prefix: | us-gaap_
Data Type: | dtr-types:textBlockItemType
Balance Type: | na
Period Type: | duration

X
- References No definition available. + Details
Name: | us-gaap_RevenueFromContractWithCustomerAbstract
Namespace Prefix: | us-gaap_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration