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Balance Sheet Components
12 Months Ended
Dec. 31, 2020
Organization Consolidation And Presentation Of Financial Statements [Abstract]  
Balance Sheet Components

7.

Balance Sheet Components

Cash and Cash Equivalents

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

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Cash

 

$

88,046

 

 

$

40,715

 

Money market funds

 

 

590,347

 

 

 

85,551

 

Total cash and cash equivalents

 

$

678,393

 

 

$

126,266

 

 

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):

 

 

 

December 31, 2020

 

 

 

Amortized Cost

 

 

Gross Unrealized

Holding Gains

 

 

Gross Unrealized

Holding Losses

 

 

Fair Value

 

Bond and mutual funds

 

$

8,147

 

 

$

 

 

$

(3

)

 

$

8,144

 

Equity investments

 

 

125

 

 

 

119

 

 

 

 

 

 

244

 

Total investments

 

$

8,272

 

 

$

119

 

 

$

(3

)

 

$

8,388

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

 

The contractual maturities of the available-for-sale investments were as follows (in thousands):

 

 

 

December 31, 2020

 

Within one year - Bond and mutual funds

 

$

8,144

 

Equity investments

 

 

244

 

Total investments

 

$

8,388

 

 

The Company periodically reviews its available-for-sale investments and term deposit for other-than-temporary impairment. The Company considers factors such as the duration, severity and the reason for the decline in value, the potential recovery period and its intent to sell. For debt securities, the Company also considers whether (i) it is more likely than not that the Company will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the three years ended December 31, 2020, the Company did not recognize any other-than-temporary impairment loss.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Raw materials

 

$

2,303

 

 

$

325

 

Work-in-progress

 

 

8,114

 

 

 

2,264

 

Finished goods

 

 

6,113

 

 

 

4,298

 

Total inventories

 

$

16,530

 

 

$

6,887

 

The Company started capitalizing inventory costs in June 2019 when FibroGen Beijing began productions of roxadustat for commercial sales purposes. The Company started capitalizing pre-launch inventory costs in the U.S. the second quarter of 2020 prior to regulatory approval. As of December 31, 2020, pre-launch inventory capitalized was 29% of the total inventory balance. The provision to write-down excess and obsolete inventory was nominal for the years ended December 31, 2020 and 2019.

Prepaid expenses and other current assets

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

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Unbilled contract assets

 

$

2,147

 

 

$

180,000

 

Deferred revenues from associated contracts

 

 

(2,147

)

 

 

(54,790

)

Net unbilled contract assets

 

 

 

 

 

125,210

 

Prepaid assets

 

 

8,353

 

 

 

6,464

 

Other current assets

 

 

1,807

 

 

 

1,717

 

Total prepaid expenses and other current assets

 

$

10,160

 

 

$

133,391

 

The unbilled contract assets as of December 31, 2020 were related to unbilled co-development revenue under the China Amendment with AstraZeneca. The unbilled contract assets as of December 31, 2019 were related to two regulatory milestones totaling $130.0 million under the Europe Agreement with Astellas associated with the planned MAA submission in Europe, and 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. See Note 4, Collaboration Agreements and Revenues, for details.

Property and Equipment

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

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Leasehold improvements

 

$

102,006

 

 

$

101,548

 

Laboratory equipment

 

 

18,143

 

 

 

17,329

 

Machinery

 

 

8,312

 

 

 

8,217

 

Computer equipment

 

 

9,545

 

 

 

8,399

 

Furniture and fixtures

 

 

6,128

 

 

 

5,822

 

Construction in progress

 

 

760

 

 

 

1,792

 

Total property and equipment

 

$

144,894

 

 

$

143,107

 

Less: accumulated depreciation

 

 

(111,247

)

 

 

(100,364

)

Property and equipment, net

 

$

33,647

 

 

$

42,743

 

Depreciation expense for the years ended December 31, 2020, 2019 and 2018 was $11.7 million, $11.1 million, and $6.6 million, respectively.

Accrued and Other Current Liabilities

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

 

 

 

December 31,

 

 

 

2020

 

 

2019

 

Preclinical and clinical trial accruals

 

$

44,113

 

 

$

16,279

 

API product price adjustment

 

 

 

 

 

36,324

 

Payroll and related accruals

 

 

22,800

 

 

 

19,784

 

Contract liabilities to pharmaceutical distributors

 

 

15,137

 

 

 

 

Accrued co-promotion expenses - current

 

 

11,537

 

 

 

 

Roxadustat profit share to AstraZeneca

 

 

7,007

 

 

 

 

Property taxes and other

 

 

5,970

 

 

 

2,044

 

Professional services

 

 

4,869

 

 

 

4,842

 

Other

 

 

8,088

 

 

 

4,543

 

Total accrued and other current liabilities

 

$

119,521

 

 

$

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. Refer to Note 4, 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. $11.5 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 December 31, 2020.

The profit share liability of $7.0 million to AstraZeneca as of December 31, 2020 represented the profit/loss share between FibroGen Beijing and AstraZeneca that is calculated pursuant to the China Agreement. This liability correspondingly reduced the deferred revenue related to the performance obligation in accordance with the China Agreement. Refer to Note 4, Collaboration Agreements and Revenues, for details.

Other Long-term Liabilities

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

 

 

December 31,

 

 

 

2020

 

 

2019

 

Accrued long-term co-promotion expenses

 

$

27,424

 

 

$

53,071

 

Other long-term tax liabilities

 

 

8,675

 

 

 

8,913

 

Operating lease liabilities, non-current

 

 

853

 

 

 

942

 

Other

 

 

2,690

 

 

 

2,481

 

Total other long-term liabilities

 

$

39,642

 

 

$

65,407

 

 

The accrued long-term co-promotional expenses of $53.1 million as of December 31, 2019 was related to the estimated amount payable to AstraZeneca for its sales and marketing efforts related to the commercial launch for roxadustat in China. 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. $27.4 million of the recalculated accrued co-promotion expenses remained in the long-term liabilities as of December 31, 2020, as it is not anticipated to be paid within the next 12 months.