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Collaboration Agreements, License Agreement and Revenues (Tables)
3 Months Ended
Mar. 31, 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 months ended March 31, 2023 and 2022 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Direct Sales:

 

 

 

 

 

 

Gross revenue

 

$

3,060

 

 

$

2,830

 

Discounts and rebates

 

 

(273

)

 

 

(175

)

Sales returns

 

 

2

 

 

 

3

 

Direct sales revenue, net

 

 

2,789

 

 

 

2,658

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

Gross transaction price

 

 

34,249

 

 

 

22,726

 

Profit share

 

 

(14,988

)

 

 

(8,849

)

Net transaction price

 

 

19,261

 

 

 

13,877

 

Decrease in deferred revenue

 

 

2,111

 

 

 

2,346

 

Sales to Falikang revenue, net

 

 

21,372

 

 

 

16,223

 

Total product revenue, net

 

$

24,161

 

 

$

18,881

 

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
March 31, 2023

 

Product revenue - AstraZeneca China
   performance obligation - deferred revenue

 

$

(175,646

)

 

$

(20,889

)

 

$

21,372

 

 

$

(163

)

 

$

(175,326

)

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 months ended March 31, 2023 and 2022 (in thousands):

 

 

 

Three Months Ended March 31,

 

 

 

2023

 

 

2022

 

Astellas Japan Agreement

 

$

1,732

 

 

$

7,594

 

Astellas Europe Agreement

 

 

377

 

 

 

 

Drug product revenue

 

$

2,109

 

 

$

7,594

 

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the Eluminex were as follows for the three months ended March 31, 2023 and 2022 (in thousands):

 

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

Eluminex

 

License revenue

 

$

6,000

 

 

$

 

 

 

Other revenue - contract manufacturing

 

$

235

 

 

$

762

 

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, 2022

 

 

Additions

 

 

Recognized as Revenue

 

 

Reclassified to Accrued Liability / Accounts Payable

 

 

Balance at
March 31, 2023

 

Drug product revenue - deferred revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Astellas Europe Agreement

 

$

(40,303

)

 

$

 

 

$

377

 

 

$

16,552

 

 

$

(23,374

)

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 months ended March 31, 2023 and 2022 (in thousands):

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

Astellas Japan Agreement

 

License revenue

 

$

 

 

$

 

 

 

Development revenue

 

$

95

 

 

$

32

 

 

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 March 31, 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 March 31, 2023

 

License

 

$

100,347

 

Development revenue

 

 

16,977

 

Total license and development revenue

 

$

117,324

 

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 months ended March 31, 2023 and 2022 (in thousands):

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

Astellas Europe Agreement

 

License revenue

 

$

 

 

$

22,590

 

 

 

Development revenue

 

$

1,529

 

 

$

5,148

 

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 March 31, 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 March 31, 2023

 

License

 

$

618,975

 

Development revenue

 

 

281,794

 

Total license and development revenue

 

$

900,769

 

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 months ended March 31, 2023 and 2022 (in thousands):

 

 

 

 

 

Three Months Ended March 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement

 

License revenue

 

$

 

 

$

 

 

 

Development revenue

 

 

2,032

 

 

 

5,819

 

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 March 31, 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 March 31, 2023

 

 

Deferred Revenue at
March 31, 2023

 

 

Total Consideration
 Through March 31, 2023

 

License

 

$

341,844

 

 

$

 

 

$

341,844

 

Co-development, information sharing &
  committee services

 

 

617,670

 

 

 

 

 

 

617,670

 

China performance obligation *

 

 

128,106

 

 

 

175,326

 

 

 

303,432

 

Total license and development revenue

 

$

1,087,620

 

 

$

175,326

 

**

$

1,262,946

 

 

* 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 March 31, 2023, deferred revenue included $156.2 million related to the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, which represents the net of $175.3 million of deferred revenue presented above and a $19.1 million unbilled co-development revenue under the AstraZeneca China Amendment.