Inventory |
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| Inventory Disclosure [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| INVENTORY | NOTE 4 - INVENTORY The following table presents the Company’s inventory as of September 30, 2026 and December 31, 2025 (in thousands):
Inventory is stated at the lower of cost or net realizable value and consists of raw materials, work-in-process and finished goods. Cost is determined using a standard cost method, which approximates actual cost, and assumes a FIFO flow of goods. Inventory that is used for clinical development purposes is expensed to research and development in the period in which it is consumed. As of September 30, 2026, the Company’s inventory was solely related to BRIUMVI. The work in process materials consist primarily of bulk drug substance, which has a multi-year shelf life. When the bulk drug substance is manufactured into BRIUMVI finished goods, those finished goods have a shelf life of three years from the date of manufacture. The Company expects to sell finished goods at least twelve months prior to expiration. Because a portion of our existing inventory will be utilized beyond our normal operating cycle, $20.8 million of inventory, comprised predominantly of work in process drug substance, is classified as Non-current Inventory at September 30, 2026. On a quarterly basis, the Company analyzes its inventory levels for excess quantities and obsolescence (expiration) by considering factors such as historical and anticipated future sales relative to quantities on hand and the remaining shelf life. As of September 30, 2026, other than the reserve described below, the Company determined that a reserve related to BRIUMVI inventory for excess quantities and obsolescence was not required. In addition, since FDA approval of BRIUMVI, the Company has not recognized any inventory write downs. The inventory reserve was $6.2 million at both September 30, 2026 and December 31, 2025 and relates to a manufacturing deviation identified by the Company affecting one batch of bulk drug substance, rendering the batch unsuitable for commercial use. The United States and other countries have recently imposed, and may continue to impose, new tariffs. Tariffs are an inventoriable cost, and the Company utilizes contract manufacturers of bulk drug substance and drug product located outside of the U.S. Based on currently applicable tariffs, the Company does not expect these costs to have a material impact on its overall gross margin.
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