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Balance Sheet Components
3 Months Ended
Mar. 31, 2023
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):

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Cash

 

$

145,810

 

 

$

135,819

 

Money market funds

 

 

42,740

 

 

 

19,881

 

Total cash and cash equivalents

 

$

188,550

 

 

$

155,700

 

 

At March 31, 2023 and December 31, 2022, a total of $98.9 million and $92.5 million 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, respectively.

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):

 

 

 

March 31, 2023

 

 

 

Amortized Cost

 

 

Gross Unrealized
Holding Gains

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

Corporate bonds

 

$

41,760

 

 

$

1

 

 

$

(457

)

 

$

41,304

 

Commercial paper

 

 

42,970

 

 

 

 

 

 

 

 

 

42,970

 

U.S. government bonds

 

 

72,130

 

 

 

1

 

 

 

(565

)

 

 

71,566

 

Agency bonds

 

 

9,183

 

 

 

 

 

 

(108

)

 

 

9,075

 

Asset-backed securities

 

 

2,491

 

 

 

 

 

 

(7

)

 

 

2,484

 

Total investments

 

$

168,534

 

 

$

2

 

 

$

(1,137

)

 

$

167,399

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

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):

 

 

 

March 31, 2023

 

 

 

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

 

$

2,469

 

 

$

(7

)

 

$

36,084

 

 

$

(450

)

 

$

38,553

 

 

$

(457

)

U.S. government bonds

 

 

4,955

 

 

 

(1

)

 

 

43,794

 

 

 

(564

)

 

 

48,749

 

 

 

(565

)

Agency bonds

 

 

 

 

 

 

 

 

9,075

 

 

 

(108

)

 

 

9,075

 

 

 

(108

)

Asset-backed securities

 

 

2,483

 

 

 

(7

)

 

 

 

 

 

 

 

 

2,483

 

 

 

(7

)

Total

 

$

9,907

 

 

$

(15

)

 

$

88,953

 

 

$

(1,122

)

 

$

98,860

 

 

$

(1,137

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

)

At March 31, 2023, the available-for-sale investments had remaining contractual maturities of less than twelve months.

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. Based on the results of its review, the Company did not recognize any other-than-temporary impairment loss during the three months ended March 31, 2023 and 2022.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

March 31, 2023

 

 

December 31, 2022

 

Raw materials

 

$

1,226

 

 

$

1,241

 

Work-in-progress

 

$

37,273

 

 

 

36,003

 

Finished goods

 

$

3,957

 

 

 

3,192

 

Total inventories

 

$

42,456

 

 

$

40,436

 

Accrued and Other Current Liabilities

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

 

 

March 31, 2023

 

 

December 31, 2022

 

Preclinical and clinical trial accruals

 

$

42,953

 

 

$

57,780

 

API and bulk drug product price true-up

 

 

30,758

 

 

 

75,055

 

Payroll and related accruals

 

 

12,230

 

 

 

22,562

 

Accrued co-promotion expenses - current

 

 

36,688

 

 

 

36,677

 

Roxadustat profit share to AstraZeneca

 

 

7,311

 

 

 

7,280

 

Property taxes and other taxes

 

 

8,041

 

 

 

7,691

 

Professional services

 

 

8,354

 

 

 

5,480

 

Current portion of liability related to sale of future revenues

 

 

3,212

 

 

 

 

Other

 

 

7,495

 

 

 

7,248

 

Total accrued and other current liabilities

 

$

157,042

 

 

$

219,773

 

The accrued liabilities of $30.8 million for API and bulk drug product price true-up as of March 31, 2023 resulted from changes in estimated variable consideration associated with the API shipments fulfilled under the terms of the Astellas Japan Amendment, the bulk drug product transferred under the terms of the Astellas Europe Agreement and the Astellas EU Supply Agreement, and the bulk drug product shipments to AstraZeneca under the terms of the AstraZeneca Master Supply Agreement. See the Drug Product Revenue section in Note 2, Collaboration Agreements, License Agreement and Revenues, for details.