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Balance Sheet Components
6 Months Ended
Jun. 30, 2020
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Balance Sheet Components

5.

Balance Sheet Components

Cash and Cash Equivalents

Cash and cash equivalents consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Cash

 

$

198,708

 

 

$

40,715

 

Money market funds

 

 

230,561

 

 

 

85,551

 

Total cash and cash equivalents

 

$

429,269

 

 

$

126,266

 

 

At June 30, 2020 and December 31, 2019, a total of $32.8 million and $11.9 million, respectively, of the Company’s cash and cash equivalents were held outside of the U.S. in its foreign subsidiaries to be used primarily for its China operations.

Investments

The Company’s investments consist of available-for-sale debt investments, marketable equity investments, term deposit and certificate of deposit. The amortized cost, gross unrealized holding gains or losses, and fair value of the Company’s investments by major investments type are summarized in the tables below (in thousands):

 

 

 

June 30, 2020

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

U.S. treasury notes and bills

 

$

225,117

 

 

$

1,062

 

 

$

 

 

$

226,179

 

Certificates of deposit

 

 

30,000

 

 

 

138

 

 

 

 

 

 

30,138

 

Equity investments

 

 

125

 

 

 

104

 

 

 

 

 

 

229

 

Total investments

 

$

255,242

 

 

$

1,304

 

 

$

 

 

$

256,546

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2019

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

U.S. treasury notes and bills

 

$

426,995

 

 

$

536

 

 

$

(25

)

 

$

427,506

 

Certificates of deposit

 

 

30,000

 

 

 

32

 

 

 

 

 

 

30,032

 

Bond and mutual funds

 

 

10,730

 

 

 

86

 

 

 

 

 

 

10,816

 

Equity investments

 

 

125

 

 

 

130

 

 

 

 

 

 

255

 

Total investments

 

$

467,850

 

 

$

784

 

 

$

(25

)

 

$

468,609

 

At June 30, 2020, all of the available-for-sale investments had contractual maturities within one year. During the three and six months ended June 30, 2020 and 2019, the Company did not recognize any other-than-temporary impairment loss.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Raw materials

 

$

327

 

 

$

325

 

Work-in-progress

 

 

3,815

 

 

 

2,264

 

Finished goods

 

 

4,440

 

 

 

4,298

 

Total inventories

 

$

8,582

 

 

$

6,887

 

The provision to write-down excess and obsolete inventory was immaterial for the three and six months ended June 30, 2020.

Prepaid expenses and other current assets

Prepaid expenses and other current assets consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Unbilled contract assets

 

$

 

 

$

180,000

 

Deferred revenues from associated contracts

 

 

 

 

 

(54,790

)

Net unbilled contract assets

 

 

 

 

 

125,210

 

Prepaid assets

 

 

4,429

 

 

 

6,464

 

Other current assets

 

 

2,052

 

 

 

1,717

 

Total prepaid expenses and other current assets

 

$

6,481

 

 

$

133,391

 

 

The unbilled contract assets as of December 31, 2019 included two regulatory milestones totaling $130.0 million under the Europe Agreement with Astellas associated with the planned MAA submission in Europe. The MAA was submitted in the second quarter of 2020. Therefore the $130 million milestones were billed in the same quarter. The unbilled contract assets as of December 31, 2019 also included a $50.0 million regulatory milestone under the U.S./RoW Agreement with AstraZeneca associated with the NDA submission in the U.S, which was submitted in December 2019 and accepted for review in February 2020. Therefore, the $50.0 million milestone was billed during the first quarter of 2020. See Note 2 for details.

Property and Equipment

Property and equipment consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Leasehold improvements

 

$

100,159

 

 

$

101,548

 

Laboratory equipment

 

 

17,362

 

 

 

17,329

 

Machinery

 

 

7,660

 

 

 

8,217

 

Computer equipment

 

 

8,930

 

 

 

8,399

 

Furniture and fixtures

 

 

5,873

 

 

 

5,822

 

Construction in progress

 

 

1,225

 

 

 

1,792

 

Total property and equipment

 

$

141,209

 

 

$

143,107

 

Less: accumulated depreciation

 

 

(104,225

)

 

 

(100,364

)

Property and equipment, net

 

$

36,984

 

 

$

42,743

 

Accrued Liabilities

Accrued liabilities consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Preclinical and clinical trial accruals

 

$

21,691

 

 

$

16,279

 

API product price adjustment

 

 

 

 

 

36,324

 

Payroll and related accruals

 

 

14,266

 

 

 

19,784

 

Property taxes and other

 

 

1,145

 

 

 

2,044

 

Professional services

 

 

5,653

 

 

 

4,842

 

Other

 

 

7,709

 

 

 

4,543

 

Total accrued liabilities

 

$

50,464

 

 

$

83,816

 

 

The amount of $36.3 million accrued as of December 31, 2019 was related to the change in estimated variable consideration of API product at the time the roxadustat listed price was issued by the Japanese Ministry of Health, Labour and Welfare. The amount was fully paid during the first quarter of 2020.

Other Long-term Liabilities

Other long-term liabilities consisted of the following (in thousands):

 

 

 

June 30, 2020

 

 

December 31, 2019

 

Accrued long-term co-promotional expenses

 

$

116,230

 

 

$

53,071

 

Other long-term tax liabilities

 

 

8,653

 

 

 

8,913

 

Operating lease liabilities, non-current

 

 

572

 

 

 

942

 

Other

 

 

1,787

 

 

 

1,340

 

Total other long-term liabilities

 

$

127,242

 

 

$

64,266

 

The accrued long-term co-promotional expenses of $116.2 million and $53.1 million as of June 30, 2020 and December 31, 2019, respectively, were related to the estimated amount payable to AstraZeneca for its sales and marketing efforts associated with the commercial launch and sales for roxadustat in China. The payment for such amount is not expected to occur within the next year. On July 8, 2020, the Parties into an amendment to the China Agreement, relating to the development and commercialization of roxadustat in China. As a result, such accrued long-term co-promotional expenses will be reduced by approximately $82 million in the third quarter of 2020. See Note 10 for details.