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

 

 

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2019

 

Direct Sales:

 

 

 

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

13,727

 

 

$

89,027

 

 

 

2,803

 

Price adjustment

 

 

(982

)

 

 

 

 

 

(936

)

Non-key account hospital listing award

 

 

95

 

 

 

(9,325

)

 

 

 

Contractual sales rebate

 

 

(832

)

 

 

(6,189

)

 

 

(149

)

Other discounts and rebates

 

 

(21

)

 

 

(923

)

 

 

(18

)

Sales returns

 

 

83

 

 

 

(92

)

 

 

 

Direct sales revenue, net

 

 

12,070

 

 

 

72,498

 

 

 

1,700

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

 

 

 

Gross transaction price

 

 

97,531

 

 

 

 

 

 

 

Profit share

 

 

(34,759

)

 

 

 

 

 

 

Net transaction price

 

 

62,772

 

 

 

 

 

 

 

Increase in deferred revenue

 

 

(27,204

)

 

 

 

 

 

 

Sales to Falikang revenue, net

 

 

35,568

 

 

 

 

 

 

 

Total product revenue, net

 

$

47,638

 

 

$

72,498

 

 

$

1,700

 

Summary of Amounts Recognized as Revenue

Amounts recognized as revenue under the Eluminex were as follows (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2019

 

Eluminex

 

License revenue

 

$

8,000

 

 

$

 

 

$

 

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

 

 

 

Balance at

December 31, 2020

 

 

Additions

 

 

Deduction

 

 

Currency

Translation

and Other

 

 

Balance at

December 31, 2021

 

Product revenue - Direct sales - contract liabilities

 

$

(15,137

)

 

$

(1,371

)

 

$

13,645

 

 

$

(313

)

 

$

(3,176

)

 

Schedule of Drug Product Revenue

Drug product revenue was as follows (in thousands):

 

 

Years Ended December 31,

 

 

 

2021

 

 

2020

 

 

2019

 

Astellas

 

$

3,186

 

 

$

4,281

 

 

$

(36,324

)

AstraZeneca

 

 

(2,224

)

 

 

4,625

 

 

 

 

Drug product revenue

 

$

962

 

 

$

8,906

 

 

$

(36,324

)

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, 2020

 

 

Additions

 

 

Recognized as Revenue

 

 

Balance at

December 31, 2021

 

Product revenue - AstraZeneca China

   performance obligation - deferred revenue

 

$

(137,338

)

 

$

(69,746

)

 

$

35,568

 

 

$

(171,516

)

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, 2020

 

 

Additions

 

 

Recognized as Revenue

 

 

Balance

Presented Net

Against

Contract Asset

 

 

Balance at

December 31, 2021

 

Astellas - Japan Agreement

 

$

 

 

$

(1,974

)

 

$

 

 

$

 

 

$

(1,974

)

Astellas - Europe Agreement

 

 

(5,984

)

 

 

(69,874

)

 

 

179

 

 

 

49,788

 

 

 

(25,891

)

AstraZeneca - U.S. Agreement

 

 

 

 

 

(11,171

)

 

 

 

 

 

 

 

 

(11,171

)

Drug product revenue - deferred revenue

 

$

(5,984

)

 

$

(83,019

)

 

$

179

 

 

$

49,788

 

 

$

(39,036

)

 

Japan [Member]  
Summary of License Revenue and Development Revenue Recognized under Agreement Amounts recognized as license revenue and development revenue under the Japan Agreement with Astellas were as follows (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2019

 

Japan

 

License revenue

 

$

 

 

$

14,323

 

 

$

11,935

 

 

 

Development revenue

 

$

248

 

 

$

1,220

 

 

$

1,222

 

 

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 and accounts receivable has been allocated to each of the following performance obligations under the Japan Agreement with Astellas, along with any associated deferred revenue as follows (in thousands):

 

Japan Agreement

 

Cumulative

Revenue

Through

December 31, 2021

 

 

Deferred

Revenue at

December 31, 2021

 

 

Total

Consideration

Through

December 31, 2021

 

License

 

$

100,347

 

 

$

 

 

$

100,347

 

Development revenue

 

 

16,598

 

 

 

 

 

 

16,598

 

Total license and development

   revenue

 

$

116,945

 

 

$

 

 

$

116,945

 

 

Europe [Member]  
Summary of License Revenue and Development Revenue Recognized under Agreement

Amounts recognized as license revenue and development revenue under the Europe Agreement with Astellas were as follows (in thousands):

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2019

 

Europe

 

License revenue

 

$

108,434

 

 

$

 

 

$

117,470

 

 

 

Development revenue

 

$

21,679

 

 

$

17,954

 

 

$

28,172

 

 

 

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 and accounts receivable has been allocated to each of the following performance obligations under the Europe Agreement with Astellas, along with any associated deferred revenue as follows (in thousands):

Europe Agreement

 

Cumulative

Revenue

Through

December 31, 2021

 

 

Deferred

Revenue at

December 31, 2021

 

 

Total

Consideration

Through

December 31, 2021

 

License

 

$

596,385

 

 

$

 

 

$

596,385

 

Development revenue

 

 

270,641

 

 

 

 

 

 

270,641

 

Total license and development

   revenue

 

$

867,026

 

 

$

 

 

$

867,026

 

 

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 U.S./RoW and China Agreements with AstraZeneca were as follows (in thousands):

 

 

 

 

 

Years Ended December 31,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2019

 

U.S. / RoW

and China

 

License revenue

 

$

 

 

$

 

 

$

47,681

 

 

 

Development revenue

 

 

48,345

 

 

 

61,508

 

 

 

84,629

 

 

 

China performance obligation

 

$

 

 

$

(90

)

 

$

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 and accounts receivable has been allocated to each of the following performance obligations under the U.S./RoW Agreement and China Agreement, along with any associated deferred revenue as follows (in thousands):

 

U.S. / RoW and China Agreements

 

Cumulative

Revenue

Through

December 31, 2021

 

 

Deferred

Revenue at

December 31, 2021

 

 

Total

Consideration

Through

December 31, 2021

 

License

 

$

341,844

 

 

$

 

 

$

341,844

 

Co-development, information sharing &

  committee services

 

 

603,119

 

 

 

 

 

 

603,119

 

China performance obligation *

 

 

35,568

 

 

 

171,516

 

 

 

207,084

 

Total license and development

   revenue

 

$

980,531

 

 

$

171,516

 

**

$

1,152,047

 

 

*

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, 2021, deferred revenue included $162.4 million related to the U.S./RoW and China Agreement, which represents the net of $171.5 million of deferred revenue presented above and a $9.1 million unbilled co-development revenue under the China Amendment with AstraZeneca.