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Collaboration Agreements, License Agreement and Revenues (Tables) | 9 Months Ended
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Sep. 30, 2023
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations and Product Revenue Net | Product revenue, net from the sales of roxadustat commercial product in China was as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
|  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
Direct Sales: |  |  |  |  |  |  |  |  |  |  |  |
Gross revenue |  | $ | 3,186 |  |  | $ | 2,610 |  |  | $ | 9,853 |  |  | $ | 8,972 |
Discounts and rebates |  |  | (261 | ) |  |  | (166 | ) |  |  | (763 | ) |  |  | (353 | )
Sales returns |  |  | 2 |  |  |  | 1 |  |  |  | 2 |  |  |  | 3 |
Direct sales revenue, net |  |  | 2,927 |  |  |  | 2,445 |  |  |  | 9,092 |  |  |  | 8,622 |
Sales to Falikang: |  |  |  |  |  |  |  |  |  |  |  |
Gross transaction price |  |  | 42,294 |  |  |  | 32,510 |  |  |  | 118,696 |  |  |  | 83,517 |
Profit share |  |  | (18,130 | ) |  |  | (12,980 | ) |  |  | (51,430 | ) |  |  | (31,894 | )
Net transaction price |  |  | 24,164 |  |  |  | 19,530 |  |  |  | 67,266 |  |  |  | 51,623 |
Decrease (increase) in deferred revenue |  |  | 2,299 |  |  |  | (4,616 | ) |  |  | 1,081 |  |  |  | (750 | )
Sales to Falikang revenue, net |  |  | 26,463 |  |  |  | 14,914 |  |  |  | 68,347 |  |  |  | 50,873 |
Total product revenue, net |  | $ | 29,390 |  |  | $ | 17,359 |  |  | $ | 77,439 |  |  | $ | 59,495 |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the related deferred revenue that is considered as a contract liability (in thousands):
|  | Balance at December 31, 2022 |  |  | Additions |  |  | Recognized as Revenue |  |  | Currency Translation and Other |  |  | Balance at September 30, 2023 |
Product revenue - AstraZeneca China performance obligation - deferred revenue |  | $ | (175,646 | ) |  | $ | (72,519 | ) |  | $ | 68,347 |  |  | $ | 2,242 |  |  | $ | (177,576 | )
Schedule of Drug Product Revenue | Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to Astellas and AstraZeneca was as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
|  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
Astellas Japan Agreement |  | $ | 695 |  |  | $ | (4,313 | ) |  | $ | 16,236 |  |  | $ | 3,297 |
Astellas Europe Agreement |  |  | 625 |  |  |  | 236 |  |  |  | 1,465 |  |  |  | 1,313 |
Drug product revenue, net |  | $ | 1,320 |  |  | $ | (4,077 | ) |  | $ | 17,701 |  |  | $ | 4,610 |
Summary of Amounts Recognized as Revenue | Amounts recognized as revenue under the Eluminex were as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
Eluminex |  | License revenue |  | $ | — |  |  | $ | — |  |  | $ | 7,000 |  |  | $ | — |
|  | Other revenue - patent transfer |  |  | 500 |  |  |  | — |  |  |  | 500 |  |  |  | — |
|  | Other revenue - contract manufacturing |  | $ | 241 |  |  | $ | 460 |  |  | $ | 723 |  |  | $ | 1,502 |
Drug Product Revenue, Net [Member] |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the above-mentioned deferred revenues that are considered as contract liabilities related to drug product (in thousands):
|  | Balance at December 31, 2022 |  |  | Additions |  |  | Recognized as Revenue |  |  | Reclassified to Accrued Liability / Accounts Payable |  |  | Balance at September 30, 2023 |
Drug product revenue - deferred revenue: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Astellas Europe Agreement |  | $ | (40,303 | ) |  | $ | — |  |  | $ | 1,465 |  |  | $ | 28,685 |  |  | $ | (10,153 | )
Japan [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Astellas Japan Agreement were as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
Astellas Japan Agreement |  | Development revenue |  | $ | 36 |  |  | $ | 45 |  |  | $ | 164 |  |  | $ | 156 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations and Product Revenue Net | The transaction price related to consideration received through September 30, 2023 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Japan Agreement (in thousands):
Astellas Japan Agreement |  | Total Consideration Through September 30, 2023 |
License |  | $ | 100,347 |
Development revenue |  |  | 17,047 |
Total license and development revenue |  | $ | 117,394 |
Europe [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Astellas Europe Agreement were as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
Astellas Europe Agreement |  | License revenue |  | $ | — |  |  | $ | — |  |  | $ | — |  |  | $ | 22,590 |
|  | Development revenue |  | $ | 2,322 |  |  | $ | 1,369 |  |  | $ | 5,657 |  |  | $ | 8,263 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations and Product Revenue Net | The transaction price related to consideration received through September 30, 2023 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Europe Agreement as follows (in thousands):
Astellas Europe Agreement |  | Total Consideration Through September 30, 2023 |
License |  | $ | 618,975 |
Development revenue |  |  | 285,922 |
Total license and development revenue |  | $ | 904,897 |
U.S./RoW and China [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement were as follows for the three and nine months ended September 30, 2023 and 2022 (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2023 |  |  | 2022 |  |  | 2023 |  |  | 2022 |
AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement |  | License revenue |  | $ | 2,649 |  |  | $ | — |  |  | $ | 2,649 |  |  | $ | — |
|  | Development revenue |  | $ | 3,676 |  |  | $ | 579 |  |  | $ | 7,981 |  |  | $ | 9,750 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations and Product Revenue Net | The transaction price relat ed to consideration received through September 30, 2023 and accounts receivable has been allocated to each of the following performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, along with any associated deferred revenue as follows (in thousands):
AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement |  | Cumulative Revenue Through September 30, 2023 |  |  | Deferred Revenue at September 30, 2023 |  |  | Total Consideration Through September 30, 2023 |
License |  | $ | 344,493 |  |  | $ | — |  |  | $ | 344,493 |
Co-development, information sharing & committee services |  |  | 623,619 |  |  |  | — |  |  |  | 623,619 |
China performance obligation * |  |  | 175,081 |  |  |  | 177,576 |  |  |  | 352,657 |
Total license and development revenue |  | $ | 1,143,193 |  |  | $ | 177,576 |  | ** | $ | 1,320,769 |
* China performance obligation revenue is recognized as product revenue, as described under Product Revenue, Net section below. ** Contract assets and liabilities related to rights and obligations in the same contract are recorded net on the consolidated balance sheets. As of September 30, 2023, deferred revenue included $151.4 million related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which represents the net of $177.6 million of deferred revenue presented above and a $26.2 million unbilled milestone and co-development revenue under the AstraZeneca China Amendment.

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