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Collaboration Agreements, License Agreement and Revenues (Tables)
12 Months Ended
Dec. 31, 2022
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, 2022, 2021 and 2020 (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2022

 

 

2021

 

 

2020

 

Direct Sales:

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

12,366

 

 

$

13,727

 

 

 

89,027

 

Price adjustment

 

 

242

 

 

 

(982

)

 

 

 

Non-key account hospital listing award

 

 

49

 

 

 

95

 

 

 

(9,325

)

Contractual sales rebate

 

 

(624

)

 

 

(832

)

 

 

(6,189

)

Other discounts and rebates

 

 

(332

)

 

 

(21

)

 

 

(923

)

Sales returns

 

 

1

 

 

 

83

 

 

 

(92

)

Direct sales revenue, net

 

 

11,702

 

 

 

12,070

 

 

 

72,498

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

Gross transaction price

 

 

112,544

 

 

 

97,531

 

 

 

 

Profit share

 

 

(43,716

)

 

 

(34,759

)

 

 

 

Net transaction price

 

 

68,828

 

 

 

62,772

 

 

 

 

Decrease (increase) in deferred revenue

 

 

2,339

 

 

 

(27,204

)

 

 

 

Sales to Falikang revenue, net

 

 

71,167

 

 

 

35,568

 

 

 

 

Total product revenue, net

 

$

82,869

 

 

$

47,638

 

 

$

72,498

 

Roll-forward of Related Contract Liabilities The following table includes a roll-forward of the related contract liabilities (in thousands):

 

 

 

Balance at
December 31, 2021

 

 

Additions

 

 

Deduction

 

 

Currency
Translation
and Other

 

 

Balance at
December 31, 2022

 

Product revenue - Direct sales - contract liabilities

 

$

(3,176

)

 

$

(653

)

 

$

3,222

 

 

$

217

 

 

$

(390

)

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, 2022, 2021 and 2020 (in thousands):

 

 

 

Years Ended December 31,

 

 

 

2022

 

 

2021

 

 

2020

 

Astellas Japan Agreement

 

$

9,480

 

 

$

2,056

 

 

$

4,281

 

Astellas Europe Agreement

 

 

1,606

 

 

 

1,130

 

 

 

 

AstraZeneca U.S./RoW Agreement

 

 

 

 

 

(2,224

)

 

 

4,625

 

Drug product revenue

 

$

11,086

 

 

$

962

 

 

$

8,906

 

 

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the agreements with Eluminex were as follows for the years ended December 31, 2022 and 2021 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2022

 

 

2021

 

Eluminex

 

License revenue

 

$

 

 

$

8,000

 

 

 

Other revenue - contract manufacturing

 

$

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, 2021

 

 

Additions

 

 

Recognized as Revenue

 

 

Currency
Translation
and Other

 

 

Balance at
December 31, 2022

 

Product revenue - AstraZeneca China
   performance obligation - deferred revenue

 

$

(171,516

)

 

$

(77,195

)

 

$

71,167

 

 

$

1,898

 

 

$

(175,646

)

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, 2021

 

 

Additions

 

 

Recognized as Revenue

 

 

Reclassified to Accrued Liability / Accounts Payable

 

 

Balance at
December 31, 2022

 

Astellas Japan Agreement

 

$

(1,974

)

 

$

(2,226

)

 

$

 

 

$

4,200

 

 

$

 

Astellas Europe Agreement

 

 

(25,891

)

 

 

(72,408

)

 

 

619

 

 

 

57,377

 

 

 

(40,303

)

AstraZeneca U.S./RoW Agreement

 

 

(11,171

)

 

 

 

 

 

 

 

 

11,171

 

 

 

 

Drug product revenue - deferred revenue

 

$

(39,036

)

 

$

(74,634

)

 

$

619

 

 

$

72,748

 

 

$

(40,303

)

 

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, 2022, 2021 and 2020 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2022

 

 

2021

 

 

2020

 

Astellas Japan Agreement

 

License revenue

 

$

 

 

$

 

 

$

14,323

 

 

 

Development revenue

 

$

284

 

 

$

248

 

 

$

1,220

 

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, 2022 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

 

Cumulative
Revenue
Through
December 31, 2022

 

 

Deferred
Revenue at
December 31, 2022

 

 

Total
Consideration
Through
December 31, 2022

 

License

 

$

100,347

 

 

$

 

 

$

100,347

 

Development revenue

 

 

16,882

 

 

 

 

 

 

16,882

 

Total license and development revenue

 

$

117,229

 

 

$

 

 

$

117,229

 

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, 2022, 2021 and 2020 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2022

 

 

2021

 

 

2020

 

Astellas Europe Agreement

 

License revenue

 

$

22,590

 

 

$

108,434

 

 

$

 

 

 

Development revenue

 

$

9,624

 

 

$

21,679

 

 

$

17,954

 

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, 2022 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

 

Cumulative
Revenue
Through
December 31, 2022

 

 

Deferred
Revenue at
December 31, 2022

 

 

Total
Consideration
Through
December 31, 2022

 

License

 

$

618,975

 

 

$

 

 

$

618,975

 

Development revenue

 

 

280,265

 

 

 

 

 

 

280,265

 

Total license and development revenue

 

$

899,240

 

 

$

 

 

$

899,240

 

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, 2022, 2021 and 2020 (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2022

 

 

2021

 

 

2020

 

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

 

License revenue

 

$

 

 

$

 

 

$

 

 

 

Development revenue

 

 

12,519

 

 

 

48,345

 

 

 

61,508

 

 

 

China performance obligation

 

$

 

 

$

 

 

$

(90

)

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, 2022 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, 2022

 

 

Deferred
Revenue at
December 31, 2022

 

 

Total
Consideration
Through
December 31, 2022

 

License

 

$

341,844

 

 

$

 

 

$

341,844

 

Co-development, information sharing &
  committee services

 

 

615,639

 

 

 

 

 

 

615,639

 

China performance obligation *

 

 

106,734

 

 

 

175,646

 

 

 

282,380

 

Total license and development revenue

 

$

1,064,217

 

 

$

175,646

 

**

$

1,239,863

 

 

* 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, 2022, deferred revenue included $158.2 million related to the AstraZeneca U.S./RoW and the AstraZeneca China Agreement, which represents the net of $175.6 million of deferred revenue presented above and a $17.5 million unbilled co-development revenue under the AstraZeneca China Amendment.