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Inventory
12 Months Ended
Dec. 31, 2020
Inventory Disclosure [Abstract]  
Inventory

6. INVENTORY

Inventory consists of the following:

 

 

 

December 31,

 

 

December 31,

 

(In thousands)

 

2020

 

 

2019

 

Raw materials

 

$

44,944

 

 

$

34,577

 

Work in process

 

 

53,243

 

 

 

54,061

 

Finished goods(1)

 

 

27,551

 

 

 

13,165

 

Total inventory

 

$

125,738

 

 

$

101,803

 

 

 

(1)

At December 31, 2020 and 2019, the Company had $26.5 million and $7.6  million, respectively, of finished goods inventory located at its third‑party warehouse and shipping service provider.

 

In November 2020, the Company received a complete response letter, which included a request for information, from the FDA regarding the LYBALVI (formerly referred to as ALKS 3831) NDA, following the FDA’s remote review of manufacturing records to the manufacture of LYBALVI at the Company’s Wilmington, Ohio facility. The NDA was resubmitted in December 2020 and the assigned the NDA a Prescription Drug User Fee Act target action date of June 1, 2021.

In the third quarter of 2020, the Company capitalized a total of $15.3 million of LYBALVI inventory in advance of regulatory approval, of which $6.3 million was subsequently expensed in the fourth quarter of 2020 as the Company determined that certain lots were no longer probable of being sold commercially. As of December 31, 2020 and 2019, the carrying value of inventory included $13.8 million and none, respectively, associated with LYBALVI, which was capitalized in advance of regulatory approval.