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Collaboration Agreements, License Agreement and Revenues (Tables)
6 Months Ended
Jun. 30, 2024
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, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Direct Sales:

 

 

 

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

4,046

 

 

$

3,607

 

 

$

7,831

 

 

$

6,667

 

Discounts and rebates

 

 

(408

)

 

 

(229

)

 

 

(767

)

 

 

(503

)

Sales returns

 

 

 

 

 

(1

)

 

 

(1

)

 

 

1

 

Direct sales revenue, net

 

 

3,638

 

 

 

3,377

 

 

 

7,063

 

 

 

6,165

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

 

 

 

Gross transaction price

 

 

49,352

 

 

 

42,153

 

 

 

92,912

 

 

 

76,402

 

Profit share

 

 

(21,397

)

 

 

(18,312

)

 

 

(40,420

)

 

 

(33,300

)

Net transaction price

 

 

27,955

 

 

 

23,841

 

 

 

52,492

 

 

 

43,102

 

Decrease (increase) in deferred revenue

 

 

18,050

 

 

 

(3,329

)

 

 

20,626

 

 

 

(1,218

)

Sales to Falikang revenue, net

 

 

46,005

 

 

 

20,512

 

 

 

73,118

 

 

 

41,884

 

Total product revenue, net

 

$

49,643

 

 

$

23,889

 

 

$

80,181

 

 

$

48,049

 

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, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Astellas Japan Agreement

 

$

(366

)

 

$

13,809

 

 

$

(2,571

)

 

$

15,541

 

Astellas Europe Agreement

 

 

1,095

 

 

 

463

 

 

 

2,116

 

 

 

840

 

AstraZeneca U.S./RoW Agreement

 

 

 

 

 

 

 

 

25,671

 

 

 

 

Drug product revenue, net

 

$

729

 

 

$

14,272

 

 

$

25,216

 

 

$

16,381

 

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the agreements with Eluminex were as follows for the three and six months ended June 30, 2024 and 2023 (in thousands):

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Eluminex

 

License revenue

 

$

 

 

$

1,000

 

 

$

 

 

$

7,000

 

 

 

Other revenue - contract manufacturing

 

$

 

 

$

246

 

 

$

116

 

 

$

482

 

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, 2023

 

 

Recognized as Revenue

 

 

Reclassified to Accrued Liability / Accounts Payable

 

 

Balance at
June 30, 2024

 

Drug product revenue - deferred revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Astellas Europe Agreement

 

$

(16,925

)

 

$

2,116

 

 

$

5,406

 

 

$

(9,403

)

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, 2023

 

 

Additions

 

 

Recognized as Revenue

 

 

Currency
Translation
and Other

 

 

Balance at
June 30, 2024

 

Product revenue - AstraZeneca China
   performance obligation - deferred revenue

 

$

(179,851

)

 

$

(53,269

)

 

$

73,118

 

 

$

1,409

 

 

$

(158,593

)

Japan [Member]  
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, 2024 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, 2024

 

License

 

$

100,347

 

Development revenue

 

 

17,100

 

Total license and development revenue

 

$

117,447

 

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, 2024 and 2023 (in thousands):

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Astellas Europe Agreement

 

Development revenue

 

$

318

 

 

$

1,806

 

 

$

606

 

 

$

3,335

 

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, 2024 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, 2024

 

License

 

$

618,975

 

Development revenue

 

 

287,322

 

Total license and development revenue

 

$

906,297

 

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, 2024 and 2023 (in thousands):

 

 

 

 

 

Three Months Ended June 30,

 

 

Six Months Ended June 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

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

 

Development revenue

 

$

(50

)

 

$

2,273

 

 

$

418

 

 

$

4,305

 

Transaction Price Related to Consideration Received and Accounts Receivable Allocated to Performance Obligations and Product Revenue Net

The transaction price related to consideration received and accounts receivable through the termination of the AstraZeneca U.S./RoW Agreement has been allocated to each of the performance obligations under the AstraZeneca U.S./RoW Agreement and AstraZeneca China Agreement, including $344.5 million for license, $625.5 million for co-development, information sharing and committee services, and $427.5 million for China performance obligation (with cumulative revenue of $268.9 million through June 30, 2024) that is recognized as product revenue, as described under Product Revenue, Net section below.