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INVENTORIES
9 Months Ended
Sep. 30, 2013
INVENTORIES  
INVENTORIES

6. INVENTORIES

 

Inventories consist of raw materials, work-in-process and finished goods related to the production of VIBATIV® (telavancin). Raw materials include VIBATIV® active pharmaceutical ingredient (API). Work-in-process includes third party manufacturing and associated labor costs relating to the Company’s personnel directly involved in the production process. Included in inventories are raw materials and work-in-process that may be used as clinical products, which are charged to research and development (R&D) expense when consumed. In addition, under certain commercialization agreements, the Company may sell VIBATIV® packaged in unlabeled vials that are recorded in work-in-process. Inventories are summarized as follows:

 

 

 

September 30,

 

December 31,

 

(In thousands)

 

2013

 

2012

 

Raw materials

 

$

4,081

 

$

5,668

 

Work-in-process

 

3,605

 

1,846

 

Finished goods

 

1,352

 

 

Total inventories

 

$

9,038

 

$

7,514

 

 

Inventories as of September 30, 2013, include $219,000 of raw materials and work-in-process related to the production of VIBATIV® (telavancin) manufactured using certain process and specification changes that have not yet received regulatory approval. The process and specification changes are required to be approved by the FDA before the product can be sold commercially, however, the Company expects to receive FDA approval and realize the costs of the inventories through future sales.