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Collaboration Agreements, License Agreement and Revenues (Tables)

9 Months Ended

Sep. 30, 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 and nine months ended September 30, 2022 and 2021 (in thousands):

		Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
Direct Sales:
Gross revenue		$	2,610			$	3,249			$	8,972			$	10,908
Discounts and rebates			(166	)			(133	)			(353	)			(1,314	)
Sales returns			1				(2	)			3				86
Direct sales revenue, net			2,445				3,114				8,622				9,680
Sales to Falikang:
Gross transaction price			32,510				31,179				83,517				82,294
Profit share			(12,980	)			(12,090	)			(31,894	)			(31,726	)
Net transaction price			19,530				19,089				51,623				50,568
Increase in deferred revenue			(4,616	)			(8,761	)			(750	)			(18,073	)
Sales to Falikang revenue, net			14,914				10,328				50,873				32,495
Total product revenue, net		$	17,359			$	13,442			$	59,495			$	42,175

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 September 30, 2022
Product revenue - Direct sales - contract liabilities		$	(3,176	)		$	(537	)		$	2,754			$	226			$	(733	)

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, 2022 and 2021 (in thousands):

		Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
Astellas Japan Agreement		$	(4,313	)		$	—			$	3,297			$	2,056
Astellas Europe Agreement			236				—				1,313				—
AstraZeneca U.S./RoW Agreement			—				—				—				(2,224	)
Drug product revenue		$	(4,077	)		$	—			$	4,610			$	(168	)

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, 2022 and 2021 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Eluminex		License revenue		$	—			$	8,000			$	—			$	8,000
Eluminex		Other revenue - contract manufacturing		$	460			$	—			$	1,502			$	—

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				Recognized as Revenue				Reclassified to Accrued Liability / Accounts Payable				Balance at September 30, 2022
Astellas Japan Agreement		$	(1,974	)		$	(2,226	)		$	—			$	4,200			$	—
Astellas Europe Agreement			(25,891	)			(72,409	)			326				50,990				(46,984	)
AstraZeneca U.S./RoW Agreement			(11,171	)			—				—				11,171				—
Drug product revenue - deferred revenue		$	(39,036	)		$	(74,635	)		$	326			$	66,361			$	(46,984	)

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				Currency Translation and Other				Balance at September 30, 2022
Product revenue - AstraZeneca China    performance obligation - deferred revenue		$	(171,516	)		$	(57,846	)		$	50,873			$	3,051			$	(175,438	)

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, 2022 and 2021 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Astellas Japan Agreement		License revenue		$	—			$	—			$	—			$	—
		Development revenue		$	45			$	66			$	156			$	245

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 through September 30, 2022 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Japan Agreement, along with any associated deferred revenue as follows (in thousands):

Astellas Japan Agreement		Cumulative Revenue Through September 30, 2022				Deferred Revenue at September 30, 2022				Total Consideration Through September 30, 2022
License		$	100,347			$	—			$	100,347
Development revenue			16,754				—				16,754
Total license and development revenue		$	117,101			$	—			$	117,101

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, 2022 and 2021 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Astellas Europe Agreement		License revenue		$	—			$	108,434			$	22,590			$	108,434
		Development revenue		$	1,369			$	14,061			$	8,263			$	20,138

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 through September 30, 2022 and accounts receivable has been allocated to each of the following performance obligations under the Astellas Europe Agreement, along with any associated deferred revenue as follows (in thousands):

Astellas Europe Agreement		Cumulative Revenue Through September 30, 2022				Deferred Revenue at September 30, 2022				Total Consideration Through September 30, 2022
License		$	618,975			$	—			$	618,975
Development revenue			278,905				—				278,905
Total license and development revenue		$	897,880			$	—			$	897,880

U.S./RoW and China [Member]

Summary of License Revenue and Development Revenue Recognized under Agreement

Amounts recognized as revenue under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement were as follows for the three and nine months ended September 30, 2022 and 2021 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2022				2021				2022				2021
AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement		License revenue		$	—			$	—			$	—			$	—
		Development revenue			579				11,970				9,750				39,939

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 through September 30, 2022 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, 2022				Deferred Revenue at September 30, 2022				Total Consideration Through September 30, 2022
License		$	341,844			$	—			$	341,844
Co-development, information sharing &   committee services			612,869				—				612,869
China performance obligation *			86,441				175,438				261,879
Total license and development revenue		$	1,041,154			$	175,438		**	$	1,216,592

* 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, 2022, deferred revenue included $160.1 million related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which represents the net of $175.4 million of deferred revenue presented above and a $15.3 million unbilled co-development revenue under the AstraZeneca China Amendment.

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