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Collaboration Agreements, License Agreement and Revenues (Tables) | 9 Months Ended
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Sep. 30, 2021
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | Product revenue, net from the sales of roxadustat commercial product in China was as follows (in thousands):
|  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
|  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
Direct Sales: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Gross revenue |  | $ | 3,249 |  |  | $ | 27,900 |  |  | $ | 10,908 |  |  | $ | 53,105 |
Discounts and rebates |  |  | (133 | ) |  |  | (5,209 | ) |  |  | (1,314 | ) |  |  | (9,721 | )
Sales returns |  |  | (2 | ) |  |  | (8 | ) |  |  | 86 |  |  |  | (53 | )
Direct sales revenue, net |  |  | 3,114 |  |  |  | 22,683 |  |  |  | 9,680 |  |  |  | 43,331 |
Sales to Falikang: |  |  |  |  |  |  |  |  |  |  |  |  |  |  |  |
Gross transfer price |  |  | 31,179 |  |  |  | — |  |  |  | 82,294 |  |  |  | — |
Profit share |  |  | (12,090 | ) |  |  | — |  |  |  | (31,726 | ) |  |  | — |
Net transfer price |  |  | 19,089 |  |  |  | — |  |  |  | 50,568 |  |  |  | — |
Increase in deferred revenue |  |  | (8,761 | ) |  |  | — |  |  |  | (18,073 | ) |  |  | — |
Sales to Falikang revenue, net |  |  | 10,328 |  |  |  | — |  |  |  | 32,495 |  |  |  | — |
Total product revenue, net |  | $ | 13,442 |  |  | $ | 22,683 |  |  | $ | 42,175 |  |  | $ | 43,331 |
Summary of Amounts Recognized as Revenue | Amounts recognized as revenue under the Eluminex were as follows (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
Eluminex |  | License revenue |  | $ | 8,000 |  |  | $ | — |  |  | $ | 8,000 |  |  | $ | — |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the contract liabilities (in thousands):
|  | Balance at December 31, 2020 |  |  | Additions |  |  | Deduction |  |  | Currency Translation and Other |  |  | Balance at September 30, 2021 |
Product revenue - Direct sales - contract liabilities |  | $ | (15,137 | ) |  | $ | (944 | ) |  | $ | 5,913 |  |  | $ | (167 | ) |  | $ | (10,335 | )
Schedule of Drug Product Revenue | Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands):
|  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
|  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
Astellas |  | $ | — |  |  | $ | (3,957 | ) |  | $ | 2,056 |  |  | $ | 4,281 |
AstraZeneca |  |  | — |  |  |  | 4,643 |  |  |  | (2,224 | ) |  |  | 4,643 |
Drug product revenue |  | $ | — |  |  | $ | 686 |  |  | $ | (168 | ) |  | $ | 8,924 |
Drug Product Revenue [Member] |
Roll-forward of Related Contract Liabilities | The following table includes a roll-forward of the above-mentioned deferred revenue s that are considered as contract liabilit ies related to drug product (in thousands):
|  | Balance at December 31, 2020 |  |  | Additions |  |  | Recognized as Revenue |  |  | Balance at September 30, 2021 |
Astellas - Japan Agreement |  | $ | — |  |  | $ | (1,974 | ) |  | $ | — |  |  | $ | (1,974 | )
Astellas - Europe Agreement |  |  | (5,984 | ) |  |  | (11,759 | ) |  |  | — |  |  |  | (17,743 | )
AstraZeneca - U.S. Agreement |  |  | — |  |  |  | (11,171 | ) |  |  | — |  |  |  | (11,171 | )
Drug product revenue - deferred revenue |  | $ | (5,984 | ) |  | $ | (24,904 | ) |  | $ | — |  |  | $ | (30,888 | )
AstraZeneca Agreements [Member] |
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, 2020 |  |  | Additions |  |  | Recognized as Revenue |  |  | Balance at September 30, 2021 |
Product revenue - AstraZeneca China performance obligation - deferred revenue |  | $ | (137,338 | ) |  | $ | (55,424 | ) |  | $ | 32,495 |  |  | $ | (160,267 | )
Japan [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
Japan |  | License revenue |  | $ | — |  |  | $ | — |  |  | $ | — |  |  | $ | — |
|  | Development revenue |  | $ | 66 |  |  | $ | 86 |  |  | $ | 245 |  |  | $ | 413 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement with Astellas, along with any associated deferred revenue as follows (in thousands):
Japan Agreement |  | Cumulative Revenue Through September 30, 2021 |  |  | Deferred Revenue at September 30, 2021 |  |  | Total Consideration Through September 30, 2021 |
License |  | $ | 100,347 |  |  | $ | — |  |  | $ | 100,347 |
Development revenue |  |  | 16,595 |  |  |  | — |  |  |  | 16,595 |
Total license and development revenue |  | $ | 116,942 |  |  | $ | — |  |  | $ | 116,942 |
Europe [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
Europe |  | License revenue |  | $ | 108,434 |  |  | $ | — |  |  | $ | 108,434 |  |  | $ | — |
|  | Development revenue |  | $ | 14,061 |  |  | $ | 4,651 |  |  | $ | 20,138 |  |  | $ | 13,827 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands):
Europe Agreement |  | Cumulative Revenue Through September 30, 2021 |  |  | Deferred Revenue at September 30, 2021 |  |  | Total Consideration Through September 30, 2021 |
License |  | $ | 596,385 |  |  | $ | — |  |  | $ | 596,385 |
Development revenue |  |  | 269,100 |  |  |  | — |  |  |  | 269,100 |
Total license and development revenue |  | $ | 865,485 |  |  | $ | — |  |  | $ | 865,485 |
U.S./RoW and China [Member] |
Summary of License Revenue and Development Revenue Recognized under Agreement | Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands):
|  |  |  | Three Months Ended September 30, |  |  | Nine Months Ended September 30, |
Agreement |  | Performance Obligation |  | 2021 |  |  | 2020 |  |  | 2021 |  |  | 2020 |
U.S. / RoW and China |  | License revenue |  | $ | — |  |  | $ | — |  |  | $ | — |  |  | $ | — |
|  | Development revenue |  |  | 11,970 |  |  |  | 15,220 |  |  |  | 39,939 |  |  |  | 43,525 |
|  | China performance obligation |  | $ | — |  |  | $ | 706 |  |  | $ | — |  |  | $ | 1,300 |
Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations along with Associated Deferred Revenue and Product Revenue Net | The transaction price related to consideration received and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement with AstraZeneca, along with any associated deferred revenue as follows (in thousands):
U.S. / RoW and China Agreements |  | Cumulative Revenue Through September 30, 2021 |  |  | Deferred Revenue at September 30, 2021 |  |  | Total Consideration Through September 30, 2021 |
License |  | $ | 341,844 |  |  | $ | — |  |  | $ | 341,844 |
Co-development, information sharing & committee services |  |  | 594,713 |  |  |  | 1,428 |  |  |  | 596,141 |
China performance obligation * |  |  | 32,495 |  |  |  | 160,267 |  |  |  | 192,762 |
Total license and development revenue |  | $ | 969,052 |  |  | $ | 161,695 |  | ** | $ | 1,130,747 |
* | China performance obligation revenue is recognized as product revenue, as described in details 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, 2021, deferred revenue included $154.7 million related to the U.S./RoW and China Agreement, which represents the net of $161.7 million of deferred revenue presented above and a $7.0 million unbilled co-development revenue under the China Amendment with AstraZeneca.

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