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Collaboration Agreements, License Agreement and Revenues (Tables)

6 Months Ended

Jun. 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 six months ended June 30, 2022 and 2021 (in thousands):

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
Direct Sales:
Gross revenue		$	3,533			$	2,230			$	6,362			$	7,659
Discounts and rebates			(13	)			(618	)			(187	)			(1,181	)
Sales returns			(1	)			(1	)			3				88
Direct sales revenue, net			3,519				1,611				6,178				6,566
Sales to Falikang:
Gross transaction price			28,281				26,714				51,007				51,115
Profit share			(10,065	)			(9,573	)			(18,914	)			(19,636	)
Net transaction price			18,216				17,141				32,093				31,479
Decrease (increase) in deferred revenue			1,521				(5,381	)			3,866				(9,312	)
Sales to Falikang revenue, net			19,737				11,760				35,959				22,167
Total product revenue, net		$	23,256			$	13,371			$	42,137			$	28,733

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 June 30, 2022
Product revenue - Direct sales - contract liabilities		$	(3,176	)		$	(286	)		$	1,903			$	157			$	(1,402	)

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 six months ended June 30, 2022 and 2021 (in thousands):

		Three Months Ended June 30,								Six Months Ended June 30,
		2022				2021				2022				2021
Astellas - Japan Agreement		$	17			$	(1,974	)		$	7,611			$	2,056
Astellas - Europe Agreement			1,076				—				1,076				—
AstraZeneca - U.S. Agreement			—				(6,674	)			—				(2,224	)
Drug product revenue		$	1,093			$	(8,648	)		$	8,687			$	(168	)

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the Eluminex were as follows for the three and six months ended June 30, 2022 and 2021 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Eluminex		Other revenue - contract manufacturing		$	280			$	—			$	1,042			$	—

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 June 30, 2022
Astellas - Japan Agreement		$	(1,974	)		$	(2,226	)		$	—			$	4,200			$	—
Astellas - Europe Agreement			(25,891	)			(72,409	)			90				43,273				(54,937	)
AstraZeneca - U.S. Agreement			(11,171	)			—				—				11,171				—
Drug product revenue - deferred revenue		$	(39,036	)		$	(74,635	)		$	90			$	58,644			$	(54,937	)

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 June 30, 2022
Product revenue - AstraZeneca China    performance obligation - deferred revenue		$	(171,516	)		$	(36,184	)		$	35,959			$	1,227			$	(170,514	)

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 and six months ended June 30, 2022 and 2021 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Japan		License revenue		$	—			$	—			$	—			$	—
		Development revenue		$	79			$	99			$	111			$	179

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 June 30, 2022				Deferred Revenue at June 30, 2022				Total Consideration Through June 30, 2022
License		$	100,347			$	—			$	100,347
Development revenue			16,709				—				16,709
Total license and development revenue		$	117,056			$	—			$	117,056

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 and six months ended June 30, 2022 and 2021 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2022				2021				2022				2021
Europe		License revenue		$	—			$	—			$	22,590			$	—
		Development revenue		$	1,746			$	2,546			$	6,894			$	6,077

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 June 30, 2022				Deferred Revenue at June 30, 2022				Total Consideration Through June 30, 2022
License		$	618,975			$	—			$	618,975
Development revenue			277,536				—				277,536
Total license and development revenue		$	896,511			$	—			$	896,511

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 and six months ended June 30, 2022 and 2021 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2022				2021				2022				2021
U.S. / RoW and China		License revenue		$	—			$	—			$	—			$	—
		Development revenue			3,352				16,993				9,171				27,969

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 June 30, 2022				Deferred Revenue at June 30, 2022				Total Consideration Through June 30, 2022
License		$	341,844			$	—			$	341,844
Co-development, information sharing &   committee services			612,290				—				612,290
China performance obligation *			71,527				170,514				242,041
Total license and development revenue		$	1,025,661			$	170,514		**	$	1,196,175

* 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 June 30, 2022, deferred revenue included $157.3 million related to the U.S./RoW Agreement and China Agreement, which represents the net of $170.5 million of deferred revenue presented above and a $13.2 million unbilled co-development revenue under the China Amendment with AstraZeneca.

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