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Balance Sheet Components
12 Months Ended
Dec. 31, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
Balance Sheet Components

8. Balance Sheet Components

Cash and Cash Equivalents

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

 

 

 

December 31,

 

 

 

2023

 

 

2022

 

Cash

 

$

63,396

 

 

$

135,819

 

Commercial paper

 

 

36,016

 

 

 

 

Money market funds

 

 

12,288

 

 

 

19,881

 

U.S. government bonds

 

 

1,988

 

 

 

 

Total cash and cash equivalents

 

$

113,688

 

 

$

155,700

 

At December 31, 2023 and 2022, a total of $32.2 million and $92.5 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, 2023

 

 

 

Amortized Cost

 

 

Gross Unrealized
Holding Gains

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

Corporate bonds

 

$

13,988

 

 

$

9

 

 

$

(5

)

 

$

13,992

 

Commercial paper

 

 

52,273

 

 

 

 

 

 

 

 

 

52,273

 

U.S. government bonds

 

 

45,783

 

 

 

20

 

 

 

 

 

 

45,803

 

Agency bonds

 

 

9,830

 

 

 

1

 

 

 

(1

)

 

 

9,830

 

Total investments

 

$

121,874

 

 

$

30

 

 

$

(6

)

 

$

121,898

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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):

 

 

 

December 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

 

$

 

 

$

 

 

$

3,495

 

 

$

(5

)

 

$

3,495

 

 

$

(5

)

U.S. government bonds

 

 

4,984

 

 

 

 

 

 

 

 

 

 

 

 

4,984

 

 

 

 

Agency bonds

 

 

4,987

 

 

 

(1

)

 

 

 

 

 

 

 

 

4,987

 

 

 

(1

)

Total

 

$

9,971

 

 

$

(1

)

 

$

3,495

 

 

$

(5

)

 

$

13,466

 

 

$

(6

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

)

 

The contractual maturities of all available-for-sale investments were with in one year as of December 31, 2023.

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, 2023, the Company did not recognize any other-than-temporary impairment loss.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

December 31,

 

 

 

2023

 

 

2022

 

Raw materials

 

$

1,376

 

 

$

1,241

 

Work-in-progress

 

 

34,614

 

 

 

36,003

 

Finished goods

 

 

5,575

 

 

 

3,192

 

Total inventories

 

$

41,565

 

 

$

40,436

 

The provision to write-down excess and obsolete inventory were immaterial as of December 31, 2023 and December 31, 2022.

Prepaid Expenses and Other Current Assets

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

 

 

 

December 31,

 

 

 

2023

 

 

2022

 

Contract assets

 

$

26,481

 

 

$

17,488

 

Deferred revenues from associated contracts

 

 

(26,481

)

 

 

(17,488

)

Net contract assets

 

 

 

 

 

 

Insurance proceeds receivable for litigation settlement

 

 

28,500

 

 

 

 

Prepaid assets

 

 

6,644

 

 

 

9,730

 

Other current assets

 

 

6,711

 

 

 

4,353

 

Total prepaid expenses and other current assets

 

$

41,855

 

 

$

14,083

 

The unbilled contract assets as of December 31, 2023 and 2022 included $22.5 million and $17.5 million, respectively, related to unbilled co-development revenue under the AstraZeneca China Amendment. In addition, the unbilled contract assets as of December 31, 2023 included the $4.0 million unbilled regulatory milestone payment under the AstraZeneca China Agreement. See the AstraZeneca China Agreement section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.

As of December 31, 2023, the Company recorded a $28.5 million receivable in prepaid expenses and other current assets, corresponding to the accrued litigation settlement of the same amount related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. As the Company maintains insurance that covers exposure related to the class action lawsuit, this amount is fully recoverable under the Company’s insurance policies. The determination that the recorded receivables are probable of collection is based on the terms of the applicable insurance policies and communications with the insurers. See the Accrued and Other Current Liabilities section below, and the Legal Proceedings and Other Matters section in Note 12, Commitments and Contingencies, for details.

Property and Equipment

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

 

 

 

December 31,

 

 

 

2023

 

 

2022

 

Leasehold improvements

 

$

102,109

 

 

$

102,580

 

Laboratory equipment

 

 

22,757

 

 

 

21,175

 

Machinery

 

 

9,454

 

 

 

9,642

 

Computer equipment

 

 

9,490

 

 

 

9,486

 

Furniture and fixtures

 

 

6,184

 

 

 

6,200

 

Construction in progress

 

 

62

 

 

 

204

 

Total property and equipment

 

$

150,056

 

 

$

149,287

 

Less: accumulated depreciation

 

 

(136,930

)

 

 

(128,682

)

Property and equipment, net

 

$

13,126

 

 

$

20,605

 

Depreciation expense for the years ended December 31, 2023, 2022 and 2021 was $9.5 million, $10.0 million and $10.2 million, respectively.

Accrued and Other Current Liabilities

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

 

 

 

December 31,

 

 

 

2023

 

 

2022

 

Preclinical and clinical trial accruals

 

$

27,663

 

 

$

57,780

 

API and bulk drug product price true-up

 

 

50,978

 

 

 

75,055

 

Litigation settlement

 

 

28,500

 

 

 

 

Payroll and related accruals

 

 

20,267

 

 

 

22,562

 

Accrued co-promotion expenses - current

 

 

10,309

 

 

 

36,677

 

Roxadustat profit share to AstraZeneca

 

 

7,084

 

 

 

7,280

 

Property taxes and other taxes

 

 

6,615

 

 

 

7,691

 

Professional services

 

 

7,103

 

 

 

5,480

 

Current portion of liability related to sale of future revenues

 

 

5,654

 

 

 

 

Accrued restructuring charge

 

 

3,697

 

 

 

 

Other

 

 

5,021

 

 

 

7,248

 

Total accrued and other current liabilities

 

$

172,891

 

 

$

219,773

 

 

The accrued liabilities of $51.0 million for API and bulk drug product price true-up as of December 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, Net section in Note 3, Collaboration Agreements, License Agreement and Revenues, for details.

 

As of December 31, 2023, the accrued litigation settlement of $28.5 million was related to the Company’s agreement in principle with plaintiffs to settle the class action lawsuit. See the Prepaid Expenses and Other Current Assets section above, and the Legal Proceedings and Other Matters section in Note 12, Commitments and Contingencies, for details.

On July 14, 2023, the Company approved a restructuring plan (the “Plan”) to lower the Company’s operating expenses. The Plan included a reduction to the Company’s U.S. workforce of approximately 32%. As a result, the Company recorded a total of $12.6 million non-recurring restructuring charge during the third quarter of 2023, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions. During the year ended December 31, 2023, total cash payments under the Plan was $8.9 million. The remaining accrued restructuring charge was $3.7 million as of December 31, 2023 and will be substantially paid out by early 2024. The Plan is in connection with the Company’s efforts to streamline operations to align with the Company’s business goals.