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Collaboration Agreements, License Agreement and Revenues (Tables)

9 Months Ended

Sep. 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 nine months ended September 30, 2023 and 2022 (in thousands):

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Direct Sales:
Gross revenue		$	3,186			$	2,610			$	9,853			$	8,972
Discounts and rebates			(261	)			(166	)			(763	)			(353	)
Sales returns			2				1				2				3
Direct sales revenue, net			2,927				2,445				9,092				8,622
Sales to Falikang:
Gross transaction price			42,294				32,510				118,696				83,517
Profit share			(18,130	)			(12,980	)			(51,430	)			(31,894	)
Net transaction price			24,164				19,530				67,266				51,623
Decrease (increase) in deferred revenue			2,299				(4,616	)			1,081				(750	)
Sales to Falikang revenue, net			26,463				14,914				68,347				50,873
Total product revenue, net		$	29,390			$	17,359			$	77,439			$	59,495

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 September 30, 2023
Product revenue - AstraZeneca China    performance obligation - deferred revenue		$	(175,646	)		$	(72,519	)		$	68,347			$	2,242			$	(177,576	)

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, 2023 and 2022 (in thousands):

		Three Months Ended September 30,								Nine Months Ended September 30,
		2023				2022				2023				2022
Astellas Japan Agreement		$	695			$	(4,313	)		$	16,236			$	3,297
Astellas Europe Agreement			625				236				1,465				1,313
Drug product revenue, net		$	1,320			$	(4,077	)		$	17,701			$	4,610

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, 2023 and 2022 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Eluminex		License revenue		$	—			$	—			$	7,000			$	—
		Other revenue - patent transfer			500				—				500				—
		Other revenue - contract manufacturing		$	241			$	460			$	723			$	1,502

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 September 30, 2023
Drug product revenue - deferred revenue:
Astellas Europe Agreement		$	(40,303	)		$	—			$	1,465			$	28,685			$	(10,153	)

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, 2023 and 2022 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Astellas Japan Agreement		Development revenue		$	36			$	45			$	164			$	156

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 September 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 September 30, 2023
License		$	100,347
Development revenue			17,047
Total license and development revenue		$	117,394

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, 2023 and 2022 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2023				2022				2023				2022
Astellas Europe Agreement		License revenue		$	—			$	—			$	—			$	22,590
		Development revenue		$	2,322			$	1,369			$	5,657			$	8,263

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 September 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 September 30, 2023
License		$	618,975
Development revenue			285,922
Total license and development revenue		$	904,897

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 nine months ended September 30, 2023 and 2022 (in thousands):

				Three Months Ended September 30,								Nine Months Ended September 30,
Agreement		Performance Obligation		2023				2022				2023				2022
AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement		License revenue		$	2,649			$	—			$	2,649			$	—
		Development revenue		$	3,676			$	579			$	7,981			$	9,750

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 September 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 September 30, 2023				Deferred Revenue at September 30, 2023				Total Consideration  Through September 30, 2023
License		$	344,493			$	—			$	344,493
Co-development, information sharing &   committee services			623,619				—				623,619
China performance obligation *			175,081				177,576				352,657
Total license and development revenue		$	1,143,193			$	177,576		**	$	1,320,769

* 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, 2023, deferred revenue included $151.4 million related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which represents the net of $177.6 million of deferred revenue presented above and a $26.2 million unbilled milestone and co-development revenue under the AstraZeneca China Amendment.

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