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Collaboration Agreements, License Agreement and Revenues (Tables)

3 Months Ended

Mar. 31, 2022

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 for the three months ended March 31, 2022 and 2021 (in thousands):

		Three Months Ended March 31,
		2022				2021
Direct Sales:
Gross revenue		$	2,830			$	5,429
Discounts and rebates			(175	)			(562	)
Sales returns			3				89
Direct sales revenue, net			2,658				4,956
Sales to Falikang:
Gross transaction price			22,726				24,401
Profit share			(8,849	)			(10,064	)
Net transaction price			13,877				14,337
Decrease (increase) in deferred revenue			2,346				(3,931	)
Sales to Falikang revenue, net			16,223				10,406
Total product revenue, net		$	18,881			$	15,362

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the Eluminex were as follows for the three months ended March 31, 2022 and 2021 (in thousands):

				Three Months Ended March 31,
Agreement		Performance Obligation		2022				2021
Eluminex		Other revenue - contract manufacturing		$	762			$	—

Roll-forward of Related Contract Liabilities

The following table includes a roll-forward of the contract liabilities (in thousands):

		Balance at December 31, 2021				Additions				Deduction				Currency Translation and Other				Balance at March 31, 2022
Product revenue - Direct sales - contract liabilities		$	(3,176	)		$	(407	)		$	835			$	(11	)		$	(2,759	)

Schedule of Drug Product Revenue

Drug product revenue from commercial-grade active pharmaceutical ingredient (“API”) or bulk drug product sales to AstraZeneca and Astellas was as follows for the three months ended March 31, 2022 and 2021 (in thousands):

		Three Months Ended March 31,
		2022				2021
Astellas		$	7,594			$	4,030
AstraZeneca			—				4,450
Drug product revenue		$	7,594			$	8,480

Drug Product Revenue [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, 2021				Additions				Reclassified to Accrued Liability				Balance at March 31, 2022
Astellas - Japan Agreement		$	(1,974	)		$	(2,226	)		$	4,200			$	—
Astellas - Europe Agreement			(25,891	)			(49,160	)			45,463				(29,588	)
AstraZeneca - U.S. Agreement			(11,171	)			—				11,171				—
Drug product revenue - deferred revenue		$	(39,036	)		$	(51,386	)		$	60,834			$	(29,588	)

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, 2021				Additions				Recognized as Revenue				Balance at March 31, 2022
Product revenue - AstraZeneca China    performance obligation - deferred revenue		$	(171,516	)		$	(15,945	)		$	16,223			$	(171,238	)

Deferred revenue includes amounts allocated to the China performance obligation under the AstraZeneca arrangement as revenue recognition associated with this unit of accounting is tied to the commercial launch of the products within China and to when the control of the manufactured commercial products is transferred to AstraZeneca

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 for the three months ended March 31, 2022 and 2021 (in thousands):

				Three Months Ended March 31,
Agreement		Performance Obligation		2022				2021
Japan		License revenue		$	—			$	—
		Development revenue		$	32			$	80

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 March 31, 2022				Deferred Revenue at March 31, 2022				Total Consideration Through March 31, 2022
License		$	100,347			$	—			$	100,347
Development revenue			16,630				—				16,630
Total license and development    revenue		$	116,977			$	—			$	116,977

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 for the three months ended March 31, 2022 and 2021 (in thousands):

				Three Months Ended March 31,
Agreement		Performance Obligation		2022				2021
Europe		License revenue		$	22,590			$	—
		Development revenue		$	5,148			$	3,531

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 March 31, 2022				Deferred Revenue at March 31, 2022				Total Consideration Through March 31, 2022
License		$	618,975			$	—			$	618,975
Development revenue			275,789				—				275,789
Total license and development    revenue		$	894,764			$	—			$	894,764

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 Agreement and China Agreement with AstraZeneca were as follows for the three months ended March 31, 2022 and 2021 (in thousands):

				Three Months Ended March 31,
Agreement		Performance Obligation		2022				2021
U.S. / RoW and China		License revenue		$	—			$	—
		Development revenue			5,819				10,976

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 March 31, 2022				Deferred Revenue at March 31, 2022				Total Consideration Through March 31, 2022
License		$	341,844			$	—			$	341,844
Co-development, information sharing &   committee services			608,938				—				608,938
China performance obligation *			51,791				171,238				223,029
Total license and development    revenue		$	1,002,573			$	171,238		**	$	1,173,811

* 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 March 31, 2022, deferred revenue included $160.0 million related to the U.S./RoW Agreement and China Agreement, which represents the net of $171.2 million of deferred revenue presented above and a $11.2 million unbilled co-development revenue under the China Amendment with AstraZeneca.

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