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INVENTORY
12 Months Ended
Dec. 31, 2016
Inventory Disclosure [Abstract]  
INVENTORY

(9) INVENTORY

Inventory consisted of the following:

 

 

 

December 31,

 

 

 

2016

 

 

2015

 

Raw materials

 

$

51,250

 

 

$

46,115

 

Work-in-process

 

 

167,788

 

 

 

150,289

 

Finished goods

 

 

136,088

 

 

 

75,279

 

Total inventory

 

$

355,126

 

 

$

271,683

 

 

In the first quarter of 2016, process qualification production activities commenced in the Company’s Shanbally facility related to Vimizim production. As of December 31, 2016, the value of the qualification campaign was $30.0 million, which was capitalized as inventory because the product is expected to be sold commercially. While the Company believes it is unlikely that the manufacturing process will not be approved for Vimizim production, should that occur, the value of the inventory would be expensed at that time.

Inventory as of December 31, 2016 included $39.1 million of pre-launch Brineura (formerly referred to as cerliponase alfa) inventory for production that commenced in the second quarter of 2016. Brineura is an investigational therapy to treat children with CLN2 disease, or late infantile neuronal ceroid lipofuscinosis, a lysosomal storage disorder primarily affecting the brain. The Company must receive marketing approval from the applicable regulators before the Brineura inventory can be sold commercially. Although regulatory approval cannot be assured, the Company expects to receive regulatory approval and realize the costs of the inventory through future sales. The Company believes that all material uncertainties related to the ultimate regulatory approval of Brineura for commercial sale have been significantly reduced based on positive data from Phase I/II clinical trial results and the filings of Biologics License Application (BLA) with the Food and Drug Administration (FDA) and the MAA with the European Medicines Agency (EMA) during the second quarter of 2016. In its evaluation, the Company also considered its historical experience with developing and commercially producing similar products for rare genetic disorders.