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Collaboration Agreements, License Agreement and Revenues (Tables)
9 Months Ended
Sep. 30, 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):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Direct Sales:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross revenue

 

$

3,249

 

 

$

27,900

 

 

$

10,908

 

 

$

53,105

 

Discounts and rebates

 

 

(133

)

 

 

(5,209

)

 

 

(1,314

)

 

 

(9,721

)

Sales returns

 

 

(2

)

 

 

(8

)

 

 

86

 

 

 

(53

)

Direct sales revenue, net

 

 

3,114

 

 

 

22,683

 

 

 

9,680

 

 

 

43,331

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Sales to Falikang:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross transfer price

 

 

31,179

 

 

 

 

 

 

82,294

 

 

 

 

Profit share

 

 

(12,090

)

 

 

 

 

 

(31,726

)

 

 

 

Net transfer price

 

 

19,089

 

 

 

 

 

 

50,568

 

 

 

 

Increase in deferred revenue

 

 

(8,761

)

 

 

 

 

 

(18,073

)

 

 

 

Sales to Falikang revenue, net

 

 

10,328

 

 

 

 

 

 

32,495

 

 

 

 

Total product revenue, net

 

$

13,442

 

 

$

22,683

 

 

$

42,175

 

 

$

43,331

 

 

 

Summary of Amounts Recognized as Revenue

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

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Eluminex

 

License revenue

 

$

8,000

 

 

$

 

 

$

8,000

 

 

$

 

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

 

 

 

Balance at

December 31, 2020

 

 

Additions

 

 

Deduction

 

 

Currency

Translation

and Other

 

 

Balance at

September 30, 2021

 

Product revenue - Direct sales - contract liabilities

 

$

(15,137

)

 

$

(944

)

 

$

5,913

 

 

$

(167

)

 

$

(10,335

)

 

Schedule of Drug Product Revenue

Drug product revenue from commercial-grade API or bulk drug product sales to AstraZeneca and Astellas was as follows (in thousands):

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

 

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Astellas

 

$

 

 

$

(3,957

)

 

$

2,056

 

 

$

4,281

 

AstraZeneca

 

 

 

 

 

4,643

 

 

 

(2,224

)

 

 

4,643

 

Drug product revenue

 

$

 

 

$

686

 

 

$

(168

)

 

$

8,924

 

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 at

September 30, 2021

 

Astellas - Japan Agreement

 

$

 

 

$

(1,974

)

 

$

 

 

$

(1,974

)

Astellas - Europe Agreement

 

 

(5,984

)

 

 

(11,759

)

 

 

 

 

 

(17,743

)

AstraZeneca - U.S. Agreement

 

 

 

 

 

(11,171

)

 

 

 

 

 

(11,171

)

Drug product revenue - deferred revenue

 

$

(5,984

)

 

$

(24,904

)

 

$

 

 

$

(30,888

)

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

September 30, 2021

 

Product revenue - AstraZeneca

    China performance obligation - deferred revenue

 

$

(137,338

)

 

$

(55,424

)

 

$

32,495

 

 

$

(160,267

)

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): 

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Japan

 

License revenue

 

$

 

 

$

 

 

$

 

 

$

 

 

 

Development revenue

 

$

66

 

 

$

86

 

 

$

245

 

 

$

413

 

 

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

September 30, 2021

 

 

Deferred

Revenue at

September 30, 2021

 

 

Total

Consideration

Through

September 30, 2021

 

License

 

$

100,347

 

 

$

 

 

$

100,347

 

Development revenue

 

 

16,595

 

 

 

 

 

 

16,595

 

Total license and development

   revenue

 

$

116,942

 

 

$

 

 

$

116,942

 

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):

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2021

 

 

2020

 

Europe

 

License revenue

 

$

108,434

 

 

$

 

 

$

108,434

 

 

$

 

 

 

Development revenue

 

$

14,061

 

 

$

4,651

 

 

$

20,138

 

 

$

13,827

 

 

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

September 30, 2021

 

 

Deferred

Revenue at

September 30, 2021

 

 

Total

Consideration

Through

September 30, 2021

 

License

 

$

596,385

 

 

$

 

 

$

596,385

 

Development revenue

 

 

269,100

 

 

 

 

 

 

269,100

 

Total license and development

   revenue

 

$

865,485

 

 

$

 

 

$

865,485

 

 

U.S./RoW and China [Member]  
Summary of License Revenue and Development Revenue Recognized under Agreement

Amounts recognized as revenue under the U.S./RoW and China Agreement with AstraZeneca were as follows (in thousands):

 

 

 

 

 

Three Months Ended September 30,

 

 

Nine Months Ended September 30,

 

Agreement

 

Performance Obligation

 

2021

 

 

2020

 

 

2021

 

 

2020

 

U.S. / RoW

and China

 

License revenue

 

$

 

 

$

 

 

$

 

 

$

 

 

 

Development revenue

 

 

11,970

 

 

 

15,220

 

 

 

39,939

 

 

 

43,525

 

 

 

China performance obligation

 

$

 

 

$

706

 

 

$

 

 

$

1,300

 

 

 

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 with AstraZeneca, along with any associated deferred revenue as follows (in thousands):

 

U.S. / RoW and China Agreements

 

Cumulative

Revenue

Through

September 30, 2021

 

 

Deferred

Revenue at

September 30, 2021

 

 

Total

Consideration

Through

September 30, 2021

 

License

 

$

341,844

 

 

$

 

 

$

341,844

 

Co-development, information sharing &

  committee services

 

 

594,713

 

 

 

1,428

 

 

 

596,141

 

China performance obligation *

 

 

32,495

 

 

 

160,267

 

 

 

192,762

 

Total license and development

   revenue

 

$

969,052

 

 

$

161,695

 

**

$

1,130,747

 

 

*

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 September 30, 2021, deferred revenue included $154.7 million related to the U.S./RoW and China Agreement, which represents the net of $161.7 million of deferred revenue presented above and a $7.0 million unbilled co-development revenue under the China Amendment with AstraZeneca.