XML 27 R14.htm IDEA: XBRL DOCUMENT
v3.22.0.1

INVENTORY | 12 Months Ended
--- | ---
Dec. 31, 2021
Inventory Disclosure [Abstract] |
INVENTORY | INVENTORY 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.

X
- References No definition available. + Details
Name: | us-gaap_InventoryDisclosureAbstract
Namespace Prefix: | us-gaap_
Data Type: | xbrli:stringItemType
Balance Type: | na
Period Type: | duration

X
- Definition The entire disclosure for inventory. Includes, but is not limited to, the basis of stating inventory, the method of determining inventory cost, the classes of inventory, and the nature of the cost elements included in inventory. + References Reference 1: http://www.xbrl.org/2003/role/disclosureRef -Publisher FASB -Name Accounting Standards Codification -Topic 330 -URI http://asc.fasb.org/topic&trid=2126998 + Details
Name: | us-gaap_InventoryDisclosureTextBlock
Namespace Prefix: | us-gaap_
Data Type: | dtr-types:textBlockItemType
Balance Type: | na
Period Type: | duration