Note 4 - Inventory

12 Months Ended

Dec. 31, 2024

Notes to Financial Statements

Inventory Disclosure [Text Block]

NOTE 4 – INVENTORY 

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

	December 31, 2024		December 31, 2023
Raw Materials	$	28,151	$	6,582
Work in Process		68,369		31,242
Finished Goods		13,938		1,999
Total Inventory	$	110,458	$	39,823

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  December 31,2024, 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 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 buildup inventory in support of 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 BRIUMVI being in the early stages of commercial launch, we continue to evaluate the length of our normal 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 December 31, 2024, 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.