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

6.

Balance Sheet Components

Cash and Cash Equivalents

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

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Cash

 

$

80,551

 

 

$

40,715

 

Money market funds

 

 

451,917

 

 

 

85,551

 

Total cash and cash equivalents

 

$

532,468

 

 

$

126,266

 

 

The underlying investments in the money market funds as of September 30, 2020 are all US government obligations. At September 30, 2020 and December 31, 2019, a total of $51.2 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):

 

 

 

September 30, 2020

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

U.S. treasury notes and bills

 

$

124,993

 

 

$

395

 

 

$

 

 

$

125,388

 

Certificates of deposit

 

 

30,000

 

 

 

10

 

 

 

 

 

 

30,010

 

Equity investments

 

 

125

 

 

 

122

 

 

 

 

 

 

247

 

Total investments

 

$

155,118

 

 

$

527

 

 

$

 

 

$

155,645

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

Inventories

Inventories consisted of the following (in thousands):

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Raw materials

 

$

1,152

 

 

$

325

 

Work-in-progress

 

 

5,616

 

 

 

2,264

 

Finished goods

 

 

5,034

 

 

 

4,298

 

Total inventories

 

$

11,803

 

 

$

6,887

 

 

The provision to write-down excess and obsolete inventory was immaterial for the three and nine months ended September 30, 2020. There was no provision to write-down excess and obsolete inventory for the three and nine months ended September 30, 2019.

Prepaid expenses and other current assets

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

 

 

 

September 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

 

 

5,549

 

 

 

6,464

 

Other current assets

 

 

6,014

 

 

 

1,717

 

Total prepaid expenses and other current assets

 

$

11,563

 

 

$

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 3, Collaboration Agreements and Revenues, for details.

Property and Equipment

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

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Leasehold improvements

 

$

101,162

 

 

$

101,548

 

Laboratory equipment

 

 

17,890

 

 

 

17,329

 

Machinery

 

 

8,012

 

 

 

8,217

 

Computer equipment

 

 

9,124

 

 

 

8,399

 

Furniture and fixtures

 

 

6,110

 

 

 

5,822

 

Construction in progress

 

 

1,506

 

 

 

1,792

 

Total property and equipment

 

$

143,804

 

 

$

143,107

 

Less: accumulated depreciation

 

 

(107,651

)

 

 

(100,364

)

Property and equipment, net

 

$

36,153

 

 

$

42,743

 

 

Accrued and Other Current Liabilities

Accrued and other current liabilities consisted of the following (in thousands):

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Preclinical and clinical trial accruals

 

$

29,396

 

 

$

16,279

 

API product price adjustment

 

 

3,957

 

 

 

36,324

 

Payroll and related accruals

 

 

19,606

 

 

 

19,784

 

Accrued co-promotion expenses - current

 

 

14,836

 

 

 

 

Property taxes and other

 

 

6,057

 

 

 

2,044

 

Professional services

 

 

7,384

 

 

 

4,842

 

Other

 

 

9,336

 

 

 

4,543

 

Total accrued and other current liabilities

 

$

90,572

 

 

$

83,816

 

 

The API product price adjustment 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 in the fourth quarter of 2019. This amount was fully paid during the first quarter of 2020. The API product price adjustment of $4.0 million accrued as of September 30, 2020 related to the change in estimated variable consideration of API product at the time an updated roxadustat listed price was issued by the same Japanese authority in the first quarter of 2020. See Note 3, Collaboration Agreements and Revenues, for details.

On July 8, 2020, the Parties entered into an amendment to the China Agreement, relating to the development and commercialization of roxadustat in China, which revised, among other things, the arrangements and calculation of the estimated co-promotion expenses payable to AstraZeneca for its sales and marketing efforts associated with the commercial sales for roxadustat in China. As a result, the previously accrued long-term co-promotion expenses were significantly reduced during the third quarter of 2020. $14.8 million of the recalculated accrued co-promotion expenses is anticipated to be paid within the next 12 months, therefore was recorded as a current liability as of September 30, 2020.

Other Long-term Liabilities

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

 

 

 

September 30, 2020

 

 

December 31, 2019

 

Accrued long-term co-promotion expenses

 

$

26,344

 

 

$

53,071

 

Other long-term tax liabilities

 

 

8,637

 

 

 

8,913

 

Operating lease liabilities, non-current

 

 

472

 

 

 

942

 

Other

 

 

2,186

 

 

 

1,340

 

Total other long-term liabilities

 

$

37,639

 

 

$

64,266

 

 

As mentioned above, the China Amendment revised the arrangements and calculation of the estimated co-promotion expenses payable to AstraZeneca. As a result, we reversed approximately $84.4 million of previously accrued long-term co-promotion expenses during the third quarter of 2020. $26.3 million of the recalculated accrued co-promotion expenses remained in the long-term liabilities as of September 30, 2020, as it is not anticipated to be paid within the next 12 months.