SUPPLEMENTAL BALANCE SHEET INFORMATION

9 Months Ended

Sep. 30, 2020

Organization, Consolidation and Presentation of Financial Statements [Abstract]

Inventory consisted of the following:


	September 30, 2020		December 31, 2019
Raw materials	$	73,857	$	74,442
Work-in-process	296,685		349,978
Finished goods	330,305		255,855
Total inventory	$	700,847	$	680,275

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. Starting in the second quarter of 2019, the Company believed that material uncertainties related to the ultimate regulatory approval of valoctocogene roxaparvovec for commercial sale had been significantly reduced and included the manufacturing-related costs for the commercial production of valoctocogene roxaparvovec in inventory. A number of factors were taken into consideration based on the information available at the time, including the 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 the marketing application is rejected, the manufacturing-related costs for the commercial production of valoctocogene roxaparvovec will be expensed to Research and Development (R&D).

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 requested 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, and recorded $81.2 million to Cost of Sales in the three and nine months ended September 30, 2020.

Accounts Payable and Accrued Liabilities consisted of the following:


	September 30, 2020		December 31, 2019
Accounts payable and accrued operating expenses	$	218,021	$	240,981
Accrued compensation expense	137,415		192,467
Accrued rebates payable	65,999		57,163
Accrued royalties payable	20,426		30,797
Lease liabilities	10,930		10,700
Value added taxes payable	7,222		8,395
Forward foreign currency exchange contracts	7,774		10,448
Deferred revenue	3,240		13,037
Other	9,376		6,633
Total accounts payable and accrued liabilities	$	480,403	$	570,621