Note 4 - Inventory

3 Months Ended

Mar. 31, 2025

Notes to Financial Statements

Inventory Disclosure [Text Block]

NOTE 4 - INVENTORY

The following table presents our inventory as of March 31, 2025 and December 31, 2024 (in thousands):

	March 31, 2025		December 31, 2024
Raw Materials	$	4,119	$	28,151
Work in Process		142,923		68,369
Finished Goods		10,717		13,938
Total Inventory	$	157,759	$	110,458

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 expense when consumed.

At March 31, 2025, all our inventory was solely related to BRIUMVI, which was approved by the FDA on December 28, 2022, at which time we began to capitalize costs to manufacture BRIUMVI. Prior to the FDA approval of BRIUMVI, all costs related to the manufacturing of BRIUMVI and related material were charged to research and development expense in the period incurred.

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.  Our expectation is to sell finished goods at least twelve months prior to expiration. Due to our long manufacturing lead time, it was necessary to build inventory levels to support BRIUMVI forecasted sales, to ensure appropriate safety stock levels, and meet our commitment to supply BRIUMVI to Neuraxpharm related to the Commercialization Agreement. As a result of being in the early stages of the BRIUMVI product launch, the Company is continuing to evaluate the length of its operating cycle.

On a quarterly basis, the Company analyzes our inventory levels for excess quantities and obsolescence (expiration), taking into account factors such as historical and anticipated future sales compared to quantities on hand and the remaining shelf-life. At March 31, 2025, we determined that a reserve related to BRIUMVI inventory for excess quantities and obsolescence is not required. In addition, since FDA approval of BRIUMVI, the Company has not recorded any inventory write downs.

The United States and other countries have recently imposed, and may continue to impose, new tariffs. Tariffs are an inventoriable cost, and our sole supplier of bulk drug substance is located outside of the U.S. While the tariffs imposed to date have not resulted in a material impact on our business and the results of operations, we continue to evaluate their impact on our business and results of operations.