INVENTORY

12 Months Ended

Dec. 31, 2021

Inventory consisted of the following:


	December 31,
	2021		2020
Raw materials	$	80,269	$	76,673
Work-in-process	415,261		308,286
Finished goods	281,139		313,589
Total inventory	$	776,669	$	698,548

In the third quarter of 2020, the Company unexpectedly received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) and a Joint Assessment Report from the European Medicines Agency (EMA) respectively, both indicating that the Company’s regulatory applications for valoctocogene roxaparvovec could not be approved in their present form and requesting additional safety and efficacy data from the ongoing Phase 3 study. The Company evaluated the impact of the new requirement for Phase 3 data that is currently unknown and determined the value of the pre-launch inventory was no longer

recoverable due to delays in anticipated regulatory approvals. As a result, the Company adjusted the pre-launch inventory to zero, its net realizable value, as of December 31, 2020. The Company recorded $24.3 million and $87.2 million to Cost of Sales during the years ended December 31, 2021 and December 31, 2020. The Company had no pre-launch inventory balance as of December 31, 2021.

See Note 1 to these Consolidated Financial Statements for additional information related to the Company’s policy on inventory produced prior to regulatory approval.