XML 35 R21.htm IDEA: XBRL DOCUMENT
v3.21.2

Collaboration, License, and Other Agreements (Tables) | 9 Months Ended
--- | ---
Sep. 30, 2021
Revenue from Contract with Customer [Abstract] |
Schedule of collaborative revenue | Net product sales consist of the following:
(In millions) |  | Three Months Ended September 30, |  | Nine Months Ended September 30,
Net Product Sales in the United States |  | 2021 |  | 2020 |  | 2021 |  | 2020
EYLEA® |  | $ | 1,473.4 |  |  | $ | 1,318.3 |  |  | $ | 4,245.1 |  |  | $ | 3,604.0 |
Libtayo® |  | 78.4 |  |  | 71.6 |  |  | 225.5 |  |  | 196.6 |
Praluent® |  | 44.8 |  |  | 48.5 |  |  | 130.0 |  |  | 95.7 | *
REGEN-COV® |  | 676.7 |  |  | 40.2 |  |  | 3,530.1 |  |  | 40.2 |
Evkeeza® |  | 6.6 |  |  | — |  |  | 9.1 |  |  | — |
ARCALYST® |  | — | ** |  | 3.6 |  |  | 2.2 | ** |  | 9.3 |
|  | $ | 2,279.9 |  |  | $ | 1,482.2 |  |  | $ | 8,142.0 |  |  | $ | 3,945.8 |
* 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.
** 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) |  |  | 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 |
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) |
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 |
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 |
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) |  | 2021 |  | 2020
Accounts receivable, net |  | $ | 536.0 |  |  | $ | 407.7 |
Deferred revenue |  | $ | 431.7 |  |  | $ | 347.7 |
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 |
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 |
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 |
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 |

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 http://asc.fasb.org/extlink&oid=123351226&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 http://asc.fasb.org/extlink&oid=123351226&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