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Balance Sheet Components
3 Months Ended
Mar. 31, 2024
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, 2024

 

 

December 31, 2023

 

Cash

 

$

37,167

 

 

$

63,396

 

Commercial paper

 

 

15,887

 

 

 

36,016

 

Money market funds

 

 

45,216

 

 

 

12,288

 

U.S. government bonds

 

 

7,464

 

 

 

1,988

 

Total cash and cash equivalents

 

$

105,734

 

 

$

113,688

 

 

At March 31, 2024 and December 31, 2023, a total of $27.6 million and $32.2 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, 2024

 

 

 

Amortized Cost

 

 

Gross Unrealized
Holding Gains

 

 

Gross Unrealized
Holding Losses

 

 

Estimated
Fair Value

 

Corporate bonds

 

$

6,073

 

 

$

2

 

 

$

 

 

$

6,075

 

Commercial paper

 

 

32,098

 

 

 

 

 

 

 

 

 

32,098

 

U.S. government bonds

 

 

28,747

 

 

 

1

 

 

 

 

 

 

28,748

 

Agency bonds

 

 

4,946

 

 

 

 

 

 

(2

)

 

 

4,944

 

Total investments

 

$

71,864

 

 

$

3

 

 

$

(2

)

 

$

71,865

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

 

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, 2024

 

 

 

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

 

U.S. government bonds

 

$

12,956

 

 

$

 

 

$

 

 

$

 

 

$

12,956

 

 

$

 

Agency bonds

 

 

4,944

 

 

 

(2

)

 

 

 

 

 

 

 

 

4,944

 

 

 

(2

)

Total

 

$

17,900

 

 

$

(2

)

 

$

 

 

$

 

 

$

17,900

 

 

$

(2

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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

)

The contractual maturities of all available-for-sale investments were within one year as of March 31, 2024.

The Company periodically assesses whether the unrealized losses on its available-for-sale investments were temporary. The Company considers factors such as the 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 impairment for its available-for-sale investments during the three months ended March 31, 2024 and 2023.

Inventories

Inventories consisted of the following (in thousands):

 

 

 

March 31, 2024

 

 

December 31, 2023

 

Raw materials

 

$

1,079

 

 

$

1,376

 

Work-in-progress

 

 

20,600

 

 

 

34,614

 

Finished goods

 

 

5,656

 

 

 

5,575

 

Total inventories

 

$

27,335

 

 

$

41,565

 

As described under Note 2, Collaboration Agreements, License Agreement and Revenues above, resulting from the termination and transition agreement related to the AstraZeneca U.S./RoW Agreement, the Company was reimbursed $12.6 million for work-in-progress inventory, which was written off and recognized as cost of goods sold during the three months ended March 31, 2024.

Prepaid Expenses and Other Current Assets

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

 

 

 

March 31, 2024

 

 

December 31, 2023

 

Contract assets

 

$

26,894

 

 

$

26,481

 

Deferred revenues from associated contracts

 

 

(26,894

)

 

 

(26,481

)

Net contract assets

 

 

 

 

 

 

Insurance proceeds receivable for litigation settlement

 

 

28,500

 

 

 

28,500

 

Prepaid assets

 

 

5,780

 

 

 

6,644

 

Other current assets

 

 

1,870

 

 

 

6,711

 

Total prepaid expenses and other current assets

 

$

36,150

 

 

$

41,855

 

The unbilled contract assets as of March 31, 2024 and December 31, 2023 included $22.9 million and $22.5 million, respectively, related to unbilled co-development revenue under the AstraZeneca China Amendment. In addition, the unbilled contract assets as of March 31, 2024 and December 31, 2023 each 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 each of March 31, 2024 and 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 10, Commitments and Contingencies, for details.

Accrued and Other Current Liabilities

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

 

 

March 31, 2024

 

 

December 31, 2023

 

Preclinical and clinical trial accruals

 

$

26,397

 

 

$

27,663

 

API and bulk drug product price true-up

 

 

57,370

 

 

 

50,978

 

Litigation settlement

 

 

28,500

 

 

 

28,500

 

Payroll and related accruals

 

 

7,398

 

 

 

20,267

 

Inventory cost related

 

 

8,521

 

 

 

 

Accrued co-promotion expenses - current

 

 

11,425

 

 

 

10,309

 

Roxadustat profit share to AstraZeneca

 

 

6,952

 

 

 

7,084

 

Property taxes and other taxes

 

 

7,346

 

 

 

6,615

 

Professional services

 

 

4,711

 

 

 

7,103

 

Current portion of liability related to sale of future revenues

 

 

1,213

 

 

 

5,654

 

Accrued restructuring charge

 

 

 

 

 

3,697

 

Other

 

 

4,453

 

 

 

5,021

 

Total accrued and other current liabilities

 

$

164,286

 

 

$

172,891

 

The accrued liabilities of $57.4 million and $51.0 million for API and bulk drug product price true-up as of March 31, 2024 and December 31, 2023, respectively, 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. Included in the balance as of March 31, 2024, the amount due to AstraZeneca was $11.5 million, as discussed under the Drug Product Revenue, Net section in Note 2, Collaboration Agreements, License Agreement and Revenues, resulting from the termination and transition agreement related to the AstraZeneca U.S./RoW Agreement, and has been settled in April 2024. In addition, the Company recorded an accrued inventory related cost of $8.5 million as of March 31, 2024, as part of the cost of goods sold resulting from this termination and transition agreement. See Note 2, Collaboration Agreements, License Agreement and Revenues, for details.

As of March 31, 2024 and 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. The Company maintains insurance that covers exposure related to the class action lawsuit. As the amount is fully recoverable under the Company’s insurance policies, the Company recorded a corresponding receivable in prepaid expenses and other current assets in the condensed consolidated balance sheet. 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 Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies, for details.