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Inventory | 9 Months Ended
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Sep. 30, 2021
Inventory Disclosure [Abstract] |
Inventory |
3. | Inventory
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 the active pharmaceutical ingredient (“API”) used in ANNOVERA and BIJUVA. One of our third party contract manufacturers that manufactures ANNOVERA has recently experienced an increase in difficulties with the manufacturing process for ANNOVERA, which has resulted in batch failures. The challenges are multifactorial and include variability in raw material supply and normal manufacturing variation due to a semi-manual process. This has recently resulted in challenges to supply ANNOVERA consistently within the approved specification 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 with the U.S. Food and Drug Administration (“FDA”) to modify the manufacturing (testing) specifications for ANNOVERA to allow for normal manufacturing variation that would increase the consistency of manufacturing and supply of ANNOVERA. There can be no assurance that such a modification will be approved by the FDA. If the FDA fails to approve the requested modification by the Prescription Drug User Fee Act (“PDUFA”) date of December 12, 2021, our third party contract manufacturer may not be able to supply us with sufficient ANNOVERA to adequately supply the market or generate sufficient revenue to meet the covenants under the Financing Agreement. If we are unable to achieve any of the total minimum net revenue requirements or otherwise comply with any other covenant of the Financing Agreement, all or a portion of our obligations under the Financing Agreement may be declared immediately due and payable, which would have an adverse effect on our business, results of operations and financial condition. 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 and ability to meet our revenue and other covenants under our Financing Agreement. Our inventory consisted of the following (in thousands):
|  | September 30, 2021 |  |  | December 31, 2020 |
Raw materials |  | $ | 3,487 |  |  | $ | 4,423 |
Work in process |  |  | 688 |  |  |  | 220 |
Finished products |  |  | 3,187 |  |  |  | 3,350 |
Inventory |  | $ | 7,362 |  |  | $ | 7,993 |

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