XML 27 R11.htm IDEA: XBRL DOCUMENT v3.24.2.u1
INVENTORIES AND PREPAID MANUFACTURING
6 Months Ended
Jun. 30, 2024
Inventory Disclosure [Abstract]  
INVENTORIES AND PREPAID MANUFACTURING INVENTORIES AND PREPAID MANUFACTURING
Inventories consists of the following (in thousands): 
 June 30, 2024December 31, 2023
Inventories, current:
Work-in-process$9,547 $4,297 
Finished goods14,325 11,394 
Inventories, current$23,872 $15,691 
Long-term inventories included in other long-term assets:
Raw materials 403 1,143 
Work-in-process14,795 8,260 
Inventories, long-term15,198 9,403 
Total inventories$39,070 $25,094 
As of June 30, 2024 and December 31, 2023, inventory consisted primarily of inventory related to the Company's commercial product, Auryxia. As of June 30, 2024 and December 31, 2023, the Company had no prepaid manufacturing costs and $0.5 million of prepaid manufacturing costs for Auryxia drug substance, respectively.
Inventory written down for Auryxia as a result of excess, obsolescence, scrap or other reasons charged to cost of product and other revenue in the unaudited condensed consolidated statement of operations and comprehensive loss totaled approximately $0.5 million and $1.1 million during the three and six months ended June 30, 2024, respectively, and $0.3 million and $0.6 million during the three and six months ended June 30, 2023, respectively. For the three and six months ended June 30, 2024, the Company realized lower cost of product and other revenue of $4.9 million and $8.6 million, respectively, due to the Company's ability to commercially sell inventory previously written down to zero, its then net realizable value.
Pre-Launch Inventory
The Company records advance payments for Vafseo active pharmaceutical ingredient, or API, or drug substance (raw materials) it expects to use for the U.S. launch and the EEA, the UK, Switzerland and Australia, or the Medice Territory, as prepaid manufacturing costs. Upon the quality release of the Vafseo batches and transfer of title to the Company from the contract manufacturing organization, or CMO, the cost of the pre-launch inventory prior to regulatory approval, including the manufacturing costs, was expensed to R&D. As of June 30, 2024 and December 31, 2023, the Company had $11.6 million and $14.0 million, respectively, of prepaid manufacturing costs for Vafseo drug substance expected to be used in the U.S. launch of Vafseo included in prepaid expenses and other current assets on the unaudited condensed consolidated balance sheets. See Note 6, Additional Balance Sheet Detail, for further information.