XML 18 R9.htm IDEA: XBRL DOCUMENT v3.22.2
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION
6 Months Ended
Jun. 30, 2022
Organization, Consolidation and Presentation of Financial Statements [Abstract]  
SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION SUPPLEMENTAL FINANCIAL STATEMENTS INFORMATION
Supplemental Balance Sheet Information
Inventory consisted of the following:
June 30,
2022
December 31,
2021
Raw materials$104,493 $80,269 
Work-in-process429,486 415,261 
Finished goods268,336 281,139 
Total inventory$802,315 $776,669 

Inventory as of June 30, 2022, included manufacturing-related costs for the commercial production of valoctocogene roxaparvovec totaling $31.8 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. Starting in the first quarter of 2022, the Company believed that material uncertainties related to the ultimate regulatory approval of valoctocogene roxaparvovec by the European Medicines Agency had been significantly reduced and the Company expects to realize economic benefit in the future. 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 and correspondence with the relevant regulatory authority following the submission of the additional two-year follow-up safety and efficacy data requested by the regulatory authority in the third quarter of 2020, historical experience, as well as potential impediments to the approval process such as product safety or efficacy, and commercialization and marketplace trends.
See Note 1 – Business Overview and Significant Accounting Policies included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021 for additional information related to the Company’s policies on inventory produced prior to regulatory approval.
Property, Plant and Equipment, Net consisted of the following:
June 30,
2022
December 31,
2021
Property, plant and equipment, gross$1,811,263 $1,756,035 
Accumulated depreciation(761,799)(720,574)
Total property, plant and equipment, net$1,049,464 $1,035,461 
Depreciation expense, net of amounts capitalized into inventory, for the three and six months ended June 30, 2022 was $9.5 million and $21.2 million, respectively. Depreciation expense, net of amounts capitalized into inventory, for the three and six months ended June 30, 2021 was $11.8 million and $24.3 million, respectively.
Intangible Assets, Net consisted of the following:
June 30,
2022
December 31,
2021
Finite-lived intangible assets$689,499 $677,350 
Accumulated amortization(320,131)(288,698)
Net carrying value$369,368 $388,652 
    
Accounts Payable and Accrued Liabilities consisted of the following:
June 30,
2022
December 31,
2021
Accounts payable and accrued operating expenses$199,251 $193,003 
Accrued compensation expense127,929 204,446 
Accrued rebates payable62,485 47,987 
Accrued royalties payable15,620 15,215 
Foreign currency exchange forward contracts10,224 6,263 
Lease liabilities10,611 10,464 
Value added taxes payable2,472 1,935 
Accrued income taxes1,568 1,213 
Deferred revenue305 6,956 
Other4,308 4,108 
Total accounts payable and accrued liabilities$434,773 $491,590 
Supplemental Statement of Comprehensive Income Information
Gain on Sale of Nonfinancial Assets, Net for the six months ended June 30, 2022 consisted of the completed sale of a Rare Pediatric Disease Priority Review Voucher (PRV) the Company received from the Food and Drug Administration (FDA) in connection with the U.S. approval of Voxzogo. As a result of the PRV sale, the Company recognized a $108.0 million net gain on sale of nonfinancial assets in the Company's Consolidated Statement of Comprehensive Income.