Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 162

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 162
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 able to do so on favorable terms or at all. There are risks, uncertainties and costs associated with identifying, licensing and advancing product candidates through successful clinical development. Even if we obtained the rights to additional product candidates, there can be no assurance those candidates would ever be advanced successfully through clinical development. Risks Related to Commercialization of Products We Develop We have no internal sales, marketing or distribution capabilities, and we may need to invest significant resources to establish those capabilities. If we are unable to timely establish those capabilities on our own or through arrangements with third parties, product launch may be delayed, commercialization may be adversely impacted, and we may not be able to generate product sales revenue. We currently do not have, and have never had, product marketing, sales or distribution infrastructure. In order to commercialize any of our product candidates, if approved for commercial sale, we must either establish a sales and marketing organization with technical expertise and supporting distribution capabilities or collaborate with third-parties that have sales and marketing experience. As we move our product candidates through development toward, and in some cases, through regulatory approval, we evaluate several options for each product candidate's commercialization strategy. These options include building our own sales force and other commercial infrastructure, or collaborating with third parties that have established sales forces and distribution systems, either to augment our own sales force and commercial infrastructure or in lieu of establishing our own sales force and commercial infrastructure. We currently have no commercialization agreements with third parties other than our license agreements with Organon for XACIATO and Bayer for Ovaprene. We may not be able to maintain our existing commercial collaborations or establish and maintain other commercial collaborations on favorable terms, on a timely basis, or at all. In addition, our product revenue and our profitability, if any, may be lower if we rely on third parties to commercialize products we develop than if we were to do it ourselves. To generate revenue from our product candidates, if approved for commercial sale, we may need to establish our own sales forces and commercial infrastructure. There are significant challenges and risks involved with building and managing a sales organization and other commercial infrastructure, even if we collaborate with third parties that have established sales forces and distribution systems to augment our own capabilities, including: • difficulties in recruiting and retaining adequate numbers of qualified individuals; 81

• providing adequate training for sales and marketing and support personnel; • effectively managing a geographically dispersed sales force; • difficulties generating sales leads; • potential lack of complementary products our sales personnel may be able to offer compared with sales