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Balance Sheet Components | 9 Months Ended
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Sep. 30, 2023
Organization, Consolidation and Presentation of Financial Statements [Abstract] |
Balance Sheet Components | 6. Balance Sheet Components Cash and Cash Equivalents Cash and cash equivalents consisted of the following (in thousands):
|  | September 30, 2023 |  |  | December 31, 2022 |
Cash |  | $ | 70,982 |  |  | $ | 135,819 |
Commercial paper |  |  | 22,942 |  |  |  | — |
Money market funds |  |  | 22,016 |  |  |  | 19,881 |
U.S. government bonds |  |  | 4,974 |  |  |  | — |
Total cash and cash equivalents |  | $ | 120,914 |  |  | $ | 155,700 |
At September 30, 2023 and December 31, 2022, a total of $60.1 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):
|  | September 30, 2023 |
|  | Amortized Cost |  |  | Gross Unrealized Holding Gains |  |  | Gross Unrealized Holding Losses |  |  | Estimated Fair Value |
Corporate bonds |  | $ | 11,987 |  |  | $ | — |  |  | $ | (77 | ) |  | $ | 11,910 |
Commercial paper |  |  | 55,859 |  |  |  | — |  |  |  | (1 | ) |  |  | 55,858 |
U.S. government bonds |  |  | 57,734 |  |  |  | 3 |  |  |  | (46 | ) |  |  | 57,691 |
Agency bonds |  |  | 4,965 |  |  |  | 2 |  |  |  | — |  |  |  | 4,967 |
Total investments |  | $ | 130,545 |  |  | $ | 5 |  |  | $ | (124 | ) |  | $ | 130,426 |
|  | 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):
|  | September 30, 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 |  | $ | 2,483 |  |  | $ | (8 | ) |  | $ | 9,427 |  |  | $ | (69 | ) |  | $ | 11,910 |  |  | $ | (77 | )
U.S. government bonds |  |  | 17,360 |  |  |  | (4 | ) |  |  | 8,960 |  |  |  | (42 | ) |  |  | 26,320 |  |  |  | (46 | )
Commercial paper |  |  | 3,481 |  |  |  | (1 | ) |  |  | — |  |  |  | — |  |  |  | 3,481 |  |  |  | (1 | )
Total |  | $ | 23,324 |  |  | $ | (13 | ) |  | $ | 18,387 |  |  | $ | (111 | ) |  | $ | 41,711 |  |  | $ | (124 | )
|  | 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 September 30, 2023, the available-for-sale investments had remaining contractual maturities of less than twelve months. 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 and 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 no t recognize any impairment for its available-for-sale investments during the three and nine months ended September 30, 2023 and 2022. Inventories Inventories consisted of the following (in thousands):
|  | September 30, 2023 |  |  | December 31, 2022 |
Raw materials |  | $ | 1,179 |  |  | $ | 1,241 |
Work-in-progress |  |  | 34,906 |  |  |  | 36,003 |
Finished goods |  |  | 4,611 |  |  |  | 3,192 |
Total inventories |  | $ | 40,696 |  |  | $ | 40,436 |
Accrued and Other Current Liabilities Accrued and other current liabilities consisted of the following (in thousands):
|  | September 30, 2023 |  |  | December 31, 2022 |
Preclinical and clinical trial accruals |  | $ | 34,670 |  |  | $ | 57,780 |
API and bulk drug product price true-up |  |  | 40,325 |  |  |  | 75,055 |
Litigation settlement |  |  | 28,500 |  |  |  | — |
Payroll and related accruals |  |  | 14,054 |  |  |  | 22,562 |
Accrued restructuring charge |  |  | 4,694 |  |  |  | — |
Accrued co-promotion expenses - current |  |  | 10,065 |  |  |  | 36,677 |
Roxadustat profit share to AstraZeneca |  |  | 6,884 |  |  |  | 7,280 |
Property taxes and other taxes |  |  | 7,950 |  |  |  | 7,691 |
Professional services |  |  | 11,016 |  |  |  | 5,480 |
Current portion of liability related to sale of future revenues |  |  | 5,860 |  |  |  | — |
Other |  |  | 6,968 |  |  |  | 7,248 |
Total accrued and other current liabilities |  | $ | 170,986 |  |  | $ | 219,773 |
The accrued liabilities of $40.3 million for API and bulk drug product price true-up as of September 30, 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 2, Collaboration Agreements, License Agreement and Revenues, for details. As of S eptember 30, 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 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 three months ended September 30, 2023, primarily consisting of notice period and severance payments, accrued vacation, and employee benefits contributions. During the three months ended September 30, 2023, total cash payments under the Plan was $7.9 million. The remaining accrued restructuring charge was $4.7 million as of September 30, 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.

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