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Note 4 - Inventory
6 Months Ended
Jun. 30, 2026
Notes to Financial Statements  
Inventory Disclosure [Text Block]

NOTE 4 - INVENTORY

 

The following table presents the Company’s inventory as of June 30, 2026 and  December 31, 2025 (in thousands):

 

  

June 30, 2026

  

December 31, 2025

 

Raw Materials

 $8,115  $12,960 

Work in Process

  193,209   112,397 

Finished Goods

  28,306   22,089 

Inventory, gross

  229,630   147,446 

Inventory Reserve

  (6,171)  (6,171)

Inventory, net

 $223,459  $141,275 
         

Reported As:

        

Inventory

  147,973  $125,586 

Non-current Inventory

  75,486   15,689 

Total Inventory

 $223,459  $141,275 

 

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.

 

On  June 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, $75.5 million of inventory, comprised predominantly of work in process drug substance, is classified as Non-current Inventory at June 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. On  June 30, 2026, 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 June 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’s sole supplier of bulk drug substance is located outside of the U.S. While the tariffs imposed to date have not had a material effect on the Company’s business or results of operations, the Company continues to evaluate their potential impact on its business and results of operations going forward.