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Balance Sheet Components
12 Months Ended
Dec. 31, 2022
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,

 

 

 

2022

 

 

2021

 

Cash

 

$

135,819

 

 

$

111,422

 

Commercial paper

 

 

 

 

 

1,000

 

Money market funds

 

 

19,881

 

 

 

58,801

 

Total cash and cash equivalents

 

$

155,700

 

 

$

171,223

 

At December 31, 2022 and 2021, a total of $92.5 million and $91.2 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 primarily of available-for-sale debt investments. 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, 2022

 

 

 

Amortized Cost

 

 

Gross Unrealized
Holding Gains

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

Corporate bonds

 

$

83,080

 

 

$

 

 

$

(1,072

)

 

$

82,008

 

Commercial paper

 

 

57,381

 

 

 

 

 

 

 

 

 

57,381

 

U.S. government bonds

 

 

112,547

 

 

 

5

 

 

 

(1,207

)

 

 

111,345

 

Agency bonds

 

 

11,690

 

 

 

 

 

 

(222

)

 

 

11,468

 

Asset-backed securities

 

 

2,484

 

 

 

 

 

 

(10

)

 

 

2,474

 

Foreign government bonds

 

 

5,007

 

 

 

 

 

 

(27

)

 

 

4,980

 

Convertible promissory note

 

 

1,000

 

 

 

 

 

 

 

 

 

1,000

 

Total investments

 

$

273,189

 

 

$

5

 

 

$

(2,538

)

 

$

270,656

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

Amortized Cost

 

 

Gross Unrealized
Holding Gains

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

Corporate bonds

 

$

183,136

 

 

$

2

 

 

$

(492

)

 

$

182,646

 

Commercial paper

 

 

68,079

 

 

 

 

 

 

 

 

 

68,079

 

U.S. government bonds

 

 

91,840

 

 

 

 

 

 

(318

)

 

 

91,522

 

Agency bonds

 

 

23,339

 

 

 

 

 

 

(64

)

 

 

23,275

 

Asset-backed securities

 

 

27,105

 

 

 

 

 

 

(18

)

 

 

27,087

 

Foreign government bonds

 

 

9,165

 

 

 

 

 

 

(11

)

 

 

9,154

 

Total investments

 

$

402,664

 

 

$

2

 

 

$

(903

)

 

$

401,763

 

The following table summarizes, for all available for sale securities in an unrealized loss position, the fair value and gross unrealized loss by length of time the security has been in a continual unrealized loss position (in thousands):

 

 

 

December 31, 2022

 

 

 

Less than 12 Months

 

 

12 Months or More

 

 

Total

 

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

Corporate bonds

 

$

6,738

 

 

$

(147

)

 

$

75,270

 

 

$

(925

)

 

$

82,008

 

 

$

(1,072

)

U.S. government bonds

 

 

22,326

 

 

 

(13

)

 

 

67,909

 

 

 

(1,194

)

 

 

90,235

 

 

 

(1,207

)

Agency bonds

 

 

 

 

 

 

 

 

11,468

 

 

 

(222

)

 

 

11,468

 

 

 

(222

)

Asset-backed securities

 

 

2,474

 

 

 

(10

)

 

 

 

 

 

 

 

 

2,474

 

 

 

(10

)

Foreign government bonds

 

 

 

 

 

 

 

 

4,980

 

 

 

(27

)

 

 

4,980

 

 

 

(27

)

Total

 

$

31,538

 

 

$

(170

)

 

$

159,627

 

 

$

(2,368

)

 

$

191,165

 

 

$

(2,538

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2021

 

 

 

Less than 12 Months

 

 

12 Months or More

 

 

Total

 

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

 

Gross Unrealized
Holding Losses

 

Corporate bonds

 

$

177,124

 

 

$

(492

)

 

$

 

 

$

 

 

$

177,124

 

 

$

(492

)

U.S. government bonds

 

 

91,522

 

 

 

(318

)

 

 

 

 

 

 

 

 

91,522

 

 

 

(318

)

Agency bonds

 

 

23,274

 

 

 

(64

)

 

 

 

 

 

 

 

 

23,274

 

 

 

(64

)

Asset-backed securities

 

 

27,087

 

 

 

(18

)

 

 

 

 

 

 

 

 

27,087

 

 

 

(18

)

Foreign government bonds

 

 

9,155

 

 

 

(11

)

 

 

 

 

 

 

 

 

9,155

 

 

 

(11

)

Total

 

$

328,162

 

 

$

(903

)

 

$

 

 

$

 

 

$

328,162

 

 

$

(903

)

 

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

 

 

 

December 31, 2022

 

 

 

Amortized Cost

 

 

Estimated
Fair Value

 

Within one year - Bond and mutual funds

 

$

268,709

 

 

$

266,308

 

After one year through three years

 

 

4,480

 

 

 

4,348

 

Total investments

 

$

273,189

 

 

$

270,656

 

 

The Company periodically reviews its available-for-sale investments 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, 2022, the Company did not recognize any other-than-temporary impairment loss.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Raw materials

 

$

1,241

 

 

$

1,363

 

Work-in-progress

 

 

36,003

 

 

 

21,499

 

Finished goods

 

 

3,192

 

 

 

8,153

 

Total inventories

 

$

40,436

 

 

$

31,015

 

The provision to write-down excess and obsolete inventory were immaterial as of December 31, 2022 and December 31, 2021.

Prepaid expenses and other current assets

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

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Contract assets

 

$

17,488

 

 

$

66,909

 

Deferred revenues from associated contracts

 

 

(17,488

)

 

 

(58,909

)

Net unbilled contract assets

 

 

 

 

 

8,000

 

Prepaid assets

 

 

9,730

 

 

 

7,383

 

Other current assets

 

 

4,353

 

 

 

5,070

 

Total prepaid expenses and other current assets

 

$

14,083

 

 

$

20,453

 

The unbilled contract assets of $17.5 million as of December 31, 2022 was related to unbilled co-development revenue under the AstraZeneca China Amendment. The unbilled contract assets as of December 31, 2021 included $49.8 million related to transfer price true up for bulk drug product under the Astellas Europe Agreement, $9.1 million related to unbilled co-development revenue under the AstraZeneca China Amendment, and the $8.0 million unbilled upfront license payment under the Eluminex Agreement. See the Eluminex Agreements section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.

Property and Equipment

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

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Leasehold improvements

 

$

102,580

 

 

$

103,352

 

Laboratory equipment

 

 

21,175

 

 

 

19,300

 

Machinery

 

 

9,642

 

 

 

8,339

 

Computer equipment

 

 

9,486

 

 

 

9,670

 

Furniture and fixtures

 

 

6,200

 

 

 

6,201

 

Construction in progress

 

 

204

 

 

 

2,423

 

Total property and equipment

 

$

149,287

 

 

$

149,285

 

Less: accumulated depreciation

 

 

(128,682

)

 

 

(121,008

)

Property and equipment, net

 

$

20,605

 

 

$

28,277

 

Depreciation expense for the years ended December 31, 2022, 2021 and 2020 was $10.0 million, $10.2 million and $11.7 million, respectively.

Accrued and Other Current Liabilities

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

 

 

 

December 31,

 

 

 

2022

 

 

2021

 

Preclinical and clinical trial accruals

 

$

57,780

 

 

$

56,283

 

API and bulk drug product price true-up

 

 

75,055

 

 

 

 

Acquired in-process research and development asset

 

 

 

 

 

35,000

 

Payroll and related accruals

 

 

22,562

 

 

 

20,909

 

Accrued co-promotion expenses - current

 

 

36,677

 

 

 

25,746

 

Contract liabilities to pharmaceutical distributors

 

 

390

 

 

 

3,176

 

Roxadustat profit share to AstraZeneca

 

 

7,280

 

 

 

7,895

 

Property taxes and other taxes

 

 

7,691

 

 

 

12,610

 

Professional services

 

 

5,480

 

 

 

6,074

 

Other

 

 

6,858

 

 

 

4,906

 

Total accrued and other current liabilities

 

$

219,773

 

 

$

172,599

 

 

The accrued liabilities of $75.1 million for API and bulk drug product price true-up as of December 31, 2022 resulted from changes in estimated variable consideration of $6.5 million associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, $57.4 million associated with the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and $11.2 million associated with the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement. See the Drug Product Revenue section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.

The acquired IPR&D asset of $35.0 million as of December 31, 2021 was related to the upfront payment to HiFiBiO under the HiFiBiO Agreement. See Note 2, Summary of Significant Accounting Policies - License Acquisition Agreement, for details.