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Collaboration Agreements, License Agreement and Revenues (Tables)

6 Months Ended

Jun. 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 six months ended June 30, 2023 and 2022 (in thousands):

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Direct Sales:
Gross revenue		$	3,607			$	3,533			$	6,667			$	6,362
Discounts and rebates			(229	)			(13	)			(503	)			(187	)
Sales returns			(1	)			(1	)			1				3
Direct sales revenue, net			3,377				3,519				6,165				6,178
Sales to Falikang:
Gross transaction price			42,153				28,281				76,402				51,007
Profit share			(18,312	)			(10,065	)			(33,300	)			(18,914	)
Net transaction price			23,841				18,216				43,102				32,093
Decrease (increase) in deferred revenue			(3,329	)			1,521				(1,218	)			3,866
Sales to Falikang revenue, net			20,512				19,737				41,884				35,959
Total product revenue, net		$	23,889			$	23,256			$	48,049			$	42,137

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 June 30, 2023
Product revenue - AstraZeneca China    performance obligation - deferred revenue		$	(175,646	)		$	(46,428	)		$	41,884			$	1,971			$	(178,219	)

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, 2023 and 2022 (in thousands):

		Three Months Ended June 30,								Six Months Ended June 30,
		2023				2022				2023				2022
Astellas Japan Agreement		$	13,809			$	17			$	15,541			$	7,611
Astellas Europe Agreement			463				1,076				840				1,076
Drug product revenue, net		$	14,272			$	1,093			$	16,381			$	8,687

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, 2023 and 2022 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Eluminex		License revenue		$	1,000			$	—			$	7,000			$	—
		Other revenue - contract manufacturing		$	246			$	280			$	482			$	1,042

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 June 30, 2023
Drug product revenue - deferred revenue:
Astellas Europe Agreement		$	(40,303	)		$	—			$	840			$	23,963			$	(15,500	)

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 six months ended June 30, 2023 and 2022 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Astellas Japan Agreement		Development revenue		$	33			$	79			$	128			$	111

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 June 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 June 30, 2023
License		$	100,347
Development revenue			17,010
Total license and development revenue		$	117,357

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 six months ended June 30, 2023 and 2022 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Astellas Europe Agreement		License revenue		$	—			$	—			$	—			$	22,590
		Development revenue		$	1,806			$	1,746			$	3,335			$	6,894

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 June 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 June 30, 2023
License		$	618,975
Development revenue			283,600
Total license and development revenue		$	902,575

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 six months ended June 30, 2023 and 2022 (in thousands):

				Three Months Ended June 30,								Six Months Ended June 30,
Agreement		Performance Obligation		2023				2022				2023				2022
AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement		Development revenue		$	2,273			$	3,352			$	4,305			$	9,171

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 June 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 June 30, 2023				Deferred Revenue at June 30, 2023				Total Consideration  Through June 30, 2023
License		$	341,844			$	—			$	341,844
Co-development, information sharing &   committee services			619,943				—				619,943
China performance obligation *			148,618				178,219				326,837
Total license and development revenue		$	1,110,405			$	178,219		**	$	1,288,624

* 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, 2023, deferred revenue included $157.4 million related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which represents the net of $178.2 million of deferred revenue presented above and a $20.8 million unbilled co-development revenue under the AstraZeneca China Amendment.

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