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Collaboration Agreements, License Agreement and Revenues (Tables)
9 Months Ended
Sep. 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 nine months ended September 30, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Direct Sales:

 

 

 

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

4,355

 

 

$

3,186

 

 

$

12,186

 

 

$

9,853

 

Discounts and rebates

 

 

(363

)

 

 

(261

)

 

 

(1,130

)

 

 

(763

)

Sales returns

 

 

(3

)

 

 

2

 

 

 

(4

)

 

 

2

 

Direct sales revenue, net

 

 

3,989

 

 

 

2,927

 

 

 

11,052

 

 

 

9,092

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

 

 

 

Gross transaction price

 

 

53,696

 

 

 

42,294

 

 

 

146,608

 

 

 

118,696

 

Profit share

 

 

(23,973

)

 

 

(18,130

)

 

 

(64,393

)

 

 

(51,430

)

Net transaction price

 

 

29,723

 

 

 

24,164

 

 

 

82,215

 

 

 

67,266

 

Decrease in deferred revenue

 

 

12,498

 

 

 

2,299

 

 

 

33,124

 

 

 

1,081

 

Sales to Falikang revenue, net

 

 

42,221

 

 

 

26,463

 

 

 

115,339

 

 

 

68,347

 

Total product revenue, net

 

$

46,210

 

 

$

29,390

 

 

$

126,391

 

 

$

77,439

 

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, 2024 and 2023 (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Astellas Japan Agreement

 

$

(1,355

)

 

$

695

 

 

$

(3,926

)

 

$

16,236

 

Astellas Europe Agreement

 

 

1,093

 

 

 

625

 

 

 

3,209

 

 

 

1,465

 

AstraZeneca U.S./RoW Agreement

 

 

 

 

 

 

 

 

25,671

 

 

 

 

Drug product revenue, net

 

$

(262

)

 

$

1,320

 

 

$

24,954

 

 

$

17,701

 

Summary of Amounts Recognized as Revenue

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

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Eluminex

 

License revenue

 

$

 

 

$

 

 

$

 

 

$

7,000

 

 

 

Other revenue - contract manufacturing

 

 

 

 

 

241

 

 

 

116

 

 

 

723

 

 

 

Other revenue - patent transfer

 

$

 

 

 

500

 

 

$

 

 

 

500

 

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
September 30, 2024

 

Drug product revenue - deferred revenue:

 

 

 

 

 

 

 

 

 

 

 

 

Astellas Europe Agreement

 

$

(16,925

)

 

$

3,210

 

 

$

5,605

 

 

$

(8,110

)

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
September 30, 2024

 

Product revenue - AstraZeneca China
   performance obligation - deferred revenue

 

$

(179,851

)

 

$

(82,185

)

 

$

115,339

 

 

$

(270

)

 

$

(146,967

)

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 September 30, 2024 and accounts receivable has been allocated to each of the performance obligations under the Astellas Japan Agreement, including $100.3 million for license and $17.1 million for co-development.

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, 2024 and 2023 (in thousands):

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

Astellas Europe Agreement

 

Development revenue

 

$

382

 

 

$

2,322

 

 

$

987

 

 

$

5,657

 

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, 2024 and 2023 (in thousands):

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2024

 

 

2023

 

 

2024

 

 

2023

 

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

 

License revenue

 

$

 

 

$

2,649

 

 

$

 

 

$

2,649

 

 

 

Development revenue

 

$

 

 

$

3,676

 

 

$

418

 

 

$

7,981