Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 212

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 212
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 be able to maintain the necessary governmental licenses and approvals to continue their manufacturing services for us. 

In addition, with respect to any finished product or key components manufactured outside the U.S., such as the API for Sildenafil Cream, which is sourced from a supplier located in India, we may experience interruptions in supply due to shipping or customs difficulties or regional instability. Furthermore, future currency fluctuations, increased shipping costs, or new or increased U.S. tariffs and trade disputes with other countries could increase our clinical development costs, and ultimately, our cost of goods sold, which could adversely impact our operating results and financial condition. 

Any of the above factors could cause us to delay or suspend anticipated or ongoing clinical trials, regulatory submissions or commercialization of a product candidate, entail higher costs, or result in being unable to effectively commercialize an approved product. Our dependence on third parties for the manufacture of our product candidates or future approved products may adversely affect our future profit margins and our ability to commercialize any products that receive marketing approval on a timely and competitive basis.

Similarly, while Organon assumed manufacturing responsibility for XACIATO from us in December 2023, commercial production and supply of XACIATO remains subject to comparable manufacturing risks as described herein, and any interruption in the commercial supply of XACIATO that directly or indirectly results in significant loss of product sales could have a material adverse effect on future payments we may receive under the traditional royalty purchase agreement we entered into with XOMA.

In some cases, we may be contractually required to obtain clinical or commercial product supplies from specific third parties or there may be a limited number of third-party suppliers of raw materials and other components of our product candidates or future products, which may heighten our dependence on those third parties, increase the risk of manufacturing disruptions, and result in higher development costs or costs of goods sold.

Our agreement with ADVA-Tec restricts our ability to engage a manufacturing source for Ovaprene other than ADVA-Tec during Ovaprene's development period as well as following regulatory approval, subject to limited exceptions. If ADVA-Tec fails to provide sufficient clinical supply of Ovaprene on anticipated timelines, our ability to complete clinical development and seek regulatory approval of Ovaprene could be significantly delayed. A substantial scale up in production of Ovaprene clinical supplies was necessary to support the ongoing Phase 3 clinical study of Ovaprene, which took longer and was more expensive than anticipated, and if Ovaprene receives marketing approval