XML 41 R31.htm IDEA: XBRL DOCUMENT v3.24.0.1
Collaboration Agreements, License Agreement and Revenues (Tables)
12 Months Ended
Dec. 31, 2023
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 years ended December 31, 2023, 2022 and 2021 (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2023

 

 

2022

 

 

2021

 

Direct Sales:

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

13,190

 

 

$

12,366

 

 

 

13,727

 

Discounts and rebates

 

 

(1,298

)

 

 

(665

)

 

 

(1,740

)

Sales returns

 

 

2

 

 

 

1

 

 

 

83

 

Direct sales revenue, net

 

 

11,894

 

 

 

11,702

 

 

 

12,070

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

Gross transaction price

 

 

154,817

 

 

 

112,544

 

 

 

97,531

 

Profit share

 

 

(66,254

)

 

 

(43,716

)

 

 

(34,759

)

Net transaction price

 

 

88,563

 

 

 

68,828

 

 

 

62,772

 

Decrease (increase) in deferred revenue

 

 

492

 

 

 

2,339

 

 

 

(27,204

)

Sales to Falikang revenue, net

 

 

89,055

 

 

 

71,167

 

 

 

35,568

 

Total product revenue, net

 

$

100,949

 

 

$

82,869

 

 

$

47,638

 

Schedule of Drug Product Revenue

Drug product revenue from commercial-grade API or bulk drug product sales to Astellas and AstraZeneca was as follows for the years ended December 31, 2023, 2022 and 2021 (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2023

 

 

2022

 

 

2021

 

Astellas Japan Agreement

 

$

15,656

 

 

$

9,480

 

 

$

2,056

 

Astellas Europe Agreement

 

 

3,097

 

 

 

1,606

 

 

 

1,130

 

AstraZeneca U.S./RoW Agreement

 

 

 

 

 

 

 

 

(2,224

)

Drug product revenue, net

 

$

18,753

 

 

$

11,086

 

 

$

962

 

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the agreements with Eluminex were as follows for the years ended December 31, 2023 and 2022 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

 

2021

 

Eluminex

 

License revenue

 

$

7,000

 

 

$

 

 

$

8,000

 

 

 

Other revenue - patent transfer

 

 

500

 

 

$

 

 

$

 

 

 

Other revenue - contract manufacturing

 

$

966

 

 

$

1,761

 

 

$

 

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, 2022

 

 

Additions

 

 

Recognized as Revenue

 

 

Currency
Translation
and Other

 

 

Balance at
December 31, 2023

 

Product revenue - AstraZeneca China
   performance obligation - deferred revenue

 

$

(175,646

)

 

$

(94,099

)

 

$

89,055

 

 

$

839

 

 

$

(179,851

)

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
December 31, 2023

 

Drug product revenue - deferred revenue:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Astellas Europe Agreement

 

$

(40,303

)

 

$

(17,674

)

 

$

2,306

 

 

$

38,746

 

 

$

(16,925

)

 

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 years ended December 31, 2023, 2022 and 2021 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

 

2021

 

Astellas Japan Agreement

 

Development revenue

 

$

210

 

 

$

284

 

 

$

248

 

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 December 31, 2023 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

 

Total Consideration
 Through
December 31, 2023

 

License

 

$

100,347

 

Development revenue

 

 

17,092

 

Total license and development revenue

 

$

117,439

 

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 years ended December 31, 2023, 2022 and 2021 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

 

2021

 

Astellas Europe Agreement

 

License revenue

 

$

 

 

$

22,590

 

 

$

108,434

 

 

 

Development revenue

 

$

6,452

 

 

$

9,624

 

 

$

21,679

 

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 December 31, 2023 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

 

Total Consideration
 Through
December 31, 2023

 

License

 

$

618,975

 

Development revenue

 

 

286,717

 

Total license and development revenue

 

$

905,692

 

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 the AstraZeneca China Agreement were as follows for the years ended December 31, 2023, 2022 and 2021 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2023

 

 

2022

 

 

2021

 

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

 

License revenue

 

$

2,649

 

 

$

 

 

$

 

 

 

Development revenue

 

$

9,473

 

 

 

12,519

 

 

 

48,345

 

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 December 31, 2023 and accounts receivable has been allocated to each of the following performance obligations under the AstraZeneca U.S./RoW Agreement and the 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
December 31, 2023

 

 

Deferred Revenue at
December 31, 2023

 

 

Total Consideration
 Through
December 31, 2023

 

License

 

$

344,493

 

 

$

 

 

$

344,493

 

Co-development, information sharing &
  committee services

 

 

625,111

 

 

 

 

 

 

625,111

 

China performance obligation *

 

 

195,789

 

 

 

179,851

 

 

 

375,640

 

Total license and development revenue

 

$

1,165,393

 

 

$

179,851

 

**

$

1,345,244

 

 

* China performance obligation revenue is recognized as product revenue, as described in details 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 December 31, 2023, deferred revenue included $153.4 million related to the AstraZeneca U.S./RoW and the AstraZeneca China Agreement, which represents the net of $179.9 million of deferred revenue presented above and a $26.5 million unbilled milestone and co-development revenue under the AstraZeneca China Amendment.