XML 27 R15.htm IDEA: XBRL DOCUMENT
v3.24.2.u1

Balance Sheet Components | 6 Months Ended
--- | ---
Jun. 30, 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):
|  | June 30, 2024 |  |  | December 31, 2023 |
Cash |  | $ | 49,894 |  |  | $ | 63,396 |
Commercial paper |  |  | 52,869 |  |  |  | 36,016 |
Money market funds |  |  | 11,080 |  |  |  | 12,288 |
U.S. government bonds |  |  | 21,891 |  |  |  | 1,988 |
Agency bonds |  |  | 4,980 |  |  |  | — |
Total cash and cash equivalents |  | $ | 140,714 |  |  | $ | 113,688 |
At June 30, 2024 and December 31, 2023, a total of $39.3 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 did no t have any short-term or long-term investments as of June 30, 2024. As of December 31, 2023, t he Company’s investments consist primarily of available-for-sale debt investments, and 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 |
The following table summarizes, for all available for sale securities in an unrealized loss position as of December 31, 2023, 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 | )
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 no t recognize any impairment for its available-for-sale investments during the three and six months ended June 30, 2024 and 2023. Inventories Inventories consisted of the following (in thousands):
|  | June 30, 2024 |  |  | December 31, 2023 |
Raw materials |  | $ | 1,018 |  |  | $ | 1,376 |
Work-in-progress |  |  | 19,492 |  |  |  | 34,614 |
Finished goods |  |  | 4,887 |  |  |  | 5,575 |
Total inventories |  | $ | 25,397 |  |  | $ | 41,565 |
As described under Note 2, Collaboration Agreements, License Agreement and Revenues above, resulting from the AstraZeneca 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):
|  | June 30, 2024 |  |  | December 31, 2023 |
Contract assets |  | $ | 27,258 |  |  | $ | 26,481 |
Deferred revenues from associated contracts |  |  | (27,258 | ) |  |  | (26,481 | )
Net contract assets |  |  | — |  |  |  | — |
Insurance proceeds receivable for litigation settlement |  |  | 28,500 |  |  |  | 28,500 |
Prepaid assets |  |  | 4,846 |  |  |  | 6,644 |
Other current assets |  |  | 3,590 |  |  |  | 6,711 |
Total prepaid expenses and other current assets |  | $ | 36,936 |  |  | $ | 41,855 |
The unbilled contract assets as of June 30, 2024 and December 31, 2023 included $23.3 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 June 30, 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 2, Collaboration Agreements, License Agreement and Revenues, for details. As of each of June 30, 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):
|  | June 30, 2024 |  |  | December 31, 2023 |
Preclinical and clinical trial accruals |  | $ | 20,091 |  |  | $ | 27,663 |
API and bulk drug product price true-up |  |  | 10,991 |  |  |  | 50,978 |
Litigation settlement |  |  | 28,500 |  |  |  | 28,500 |
Payroll and related accruals |  |  | 10,292 |  |  |  | 20,267 |
Inventory cost related |  |  | 8,521 |  |  |  | — |
Accrued co-promotion expenses - current |  |  | 13,209 |  |  |  | 10,309 |
Roxadustat profit share to AstraZeneca |  |  | 6,909 |  |  |  | 7,084 |
Property taxes and other taxes |  |  | 4,674 |  |  |  | 6,615 |
Professional services |  |  | 5,616 |  |  |  | 7,103 |
Current portion of liability related to sale of future revenues |  |  | 631 |  |  |  | 5,654 |
Accrued restructuring charge |  |  | — |  |  |  | 3,697 |
Other |  |  | 4,140 |  |  |  | 5,021 |
Total accrued and other current liabilities |  | $ | 113,574 |  |  | $ | 172,891 |
The accrued liabilities of $11.0 million and $51.0 million for API and bulk drug product price true-up as of June 30, 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. During the three months ended June 30, 2024, the Company paid $35.3 million to Astellas and $11.5 million to AstraZeneca related to accrued amounts. See the Drug Product Revenue, Net section in Note 2, Collaboration Agreements, License Agreement and Revenues, for details. As of June 30, 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, as mentioned above. See the Legal Proceedings and Other Matters section in Note 10, Commitments and Contingencies, for details. The Company recorded an accrued inventory related cost of $8.5 million as of June 30, 2024, as part of the cost of goods sold resulting from the AstraZeneca Termination and Transition Agreement, discussed under Note 2, Collaboration Agreements, License Agreement and Revenues.

X
- References No definition available. + Details
Name: | us-gaap_OrganizationConsolidationAndPresentationOfFinancialStatementsAbstract
Namespace Prefix: | us-gaap_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration

X
- Definition The entire disclosure for supplemental balance sheet disclosures, including descriptions and amounts for assets, liabilities, and equity. + References Reference 1: http://www.xbrl.org/2009/role/commonPracticeRef -Topic 210 -Name Accounting Standards Codification -Publisher FASB -URI https://asc.fasb.org/210/tableOfContent + Details
Name: | us-gaap_SupplementalBalanceSheetDisclosuresTextBlock
Namespace Prefix: | us-gaap_
Data Type: | dtr-types:textBlockItemType
Balance Type: | na
Period Type: | duration