INVENTORY

12 Months Ended

Dec. 31, 2019

Inventory Disclosure [Abstract]

INVENTORY

INVENTORY

Inventory consisted of the following:

	December 31,
	2019		2018
Raw materials	$	74,442	$	74,616
Work-in-process	349,978		231,064
Finished goods	255,855		225,191
Total inventory	$	680,275	$	530,871

Inventory as of December 31, 2019, included manufacturing-related costs for the commercial production of valoctocogene roxaparvovec inventory totaling $29.2 million. Valoctocogene roxaparvovec is an investigational gene therapy product candidate for the treatment of severe hemophilia A. The Company must receive marketing approval from the applicable regulators before the valoctocogene roxaparvovec inventory can be sold commercially. The Company believes that all material uncertainties related to the ultimate regulatory approval of valoctocogene roxaparvovec for commercial sale have been significantly reduced. A number of factors were taken into consideration, including the current status in the drug development process, pivotal clinical trial results for the underlying product candidate, results from meetings with the relevant regulatory authorities prior to the filing of regulatory applications, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, as well as commercialization and marketplace trends. If regulatory approval is not obtained, the manufacturing-related costs for the commercial production of valoctocogene roxaparvovec will be expensed to R&D.