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Inventory | 6 Months Ended
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Jun. 30, 2022
Inventory Disclosure [Abstract] |
Inventory |
3. | Inventory
Our inventory consisted of the following (in thousands):
|  | June 30, 2022 |  |  | December 31, 2021 |
Raw materials |  | $ | 434 |  |  | $ | 3,042 |
Work in process |  |  | 1,683 |  |  |  | 1,642 |
Finished products |  |  | 4,033 |  |  |  | 2,938 |
Inventory |  | $ | 6,150 |  |  | $ | 7,622 |
We recorded no inventory charges for the three months ended June 30, 2022 and 2021, and $0.1 million and $0.5 million for the six months ended June 30, 2022 and 2021, respectively. We rely on third parties to manufacture our finished products, and we have entered into long-term supply agreements for the manufacture of ANNOVERA, IMVEXXY, and BIJUVA. We do not have a long-term supply agreement for the manufacture of our prescription vitamins. Additionally, we do not have long-term contracts for the supply of all the active pharmaceutical ingredients (“API”) used in ANNOVERA and BIJUVA. One of our third-party contract manufacturers that manufactures ANNOVERA experienced an increase in difficulties with manufacturing of ANNOVERA, which resulted in intermittent supply interruptions of ANNOVERA for commercial distribution. The challenges are multifactorial and include variability in raw material supply and normal manufacturing variation due to a semi-manual process. This resulted in challenges to supply ANNOVERA at a rate that meets the projected demand for ANNOVERA. To mitigate the manufacturing challenges, in August 2021, we filed a supplemental New Drug Application (“NDA”) with the FDA to modify the testing specifications for ANNOVERA to allow increased consistency of supply of ANNOVERA. In December 2021, the FDA determined that it could not approve the supplemental NDA without additional information. In its complete response letter (“CRL”), the FDA provided recommendations and requested additional information that could support approval of revisions to certain testing specifications. In January 2022, we responded to the CRL, and provided additional information to the FDA and modified the request to revise the manufacturing testing limits. In May 2022, the FDA approved the supplemental NDA for ANNOVERA. With this approval, we expect our third-party contract manufacturer will be able to supply us with sufficient ANNOVERA to better meet customer demand. We have also experienced a greater than expected number of batches of raw materials for ANNOVERA being out of specification. If any of our third-party contract manufacturers or any suppliers of raw materials or API experience further difficulties, do not comply with the terms of an agreement between us, or do not devote sufficient time, energy, and care to providing our manufacturing needs, we could experience additional interruptions in the supply of our products, which may have a material adverse impact on our revenue, results of operations and financial position.

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- 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 https://asc.fasb.org/topic&trid=2126998 + Details
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