Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 223

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 223
---
 competing therapies or products; and

•the existence and extent of pending or potential product liability claims.

If XACIATO or any future product does not achieve an adequate level of market acceptance, the product may not generate significant revenue or may generate substantially less revenue than anticipated, which  could have a material and adverse effect on our business, financial condition, results of operation and prospects. We may suffer reputational harm and we may never become profitable.

The commercial success of XACIATO is outside of our control and will depend on Organon’s efforts and capabilities, as well as a variety of factors, many of which currently are unknown or uncertain, and if commercialization of XACIATO is not successful, our business and prospects may suffer. 

If commercialization of XACIATO is not successful, or is perceived to be unsuccessful, our business, financial condition, results of operations and prospects may suffer, particularly because XACIATO is the first and only product for which we have received regulatory approval. XACIATO’s commercial success will depend on many factors, including those discussed elsewhere in these “Risks Related to Commercialization of Products We Develop” and “Risks Related to Our Intellectual Property” below, as well as the capabilities of Organon and its commitment of sufficient resources to market, distribute and sell the product, preferences by health care providers and women for a vaginally administered therapy, and regulatory approval and market introduction of alternative therapies, including non-antibiotic treatment options. We have limited control over Organon’s efforts with respect to XACIATO and there is no assurance they will be successful or that the Revenue Sharing Threshold will be reached. As discussed elsewhere in this Risk Factors section, we will not receive any payments based on product sales until after the Revenue Sharing Threshold is reached. We may suffer reputational harm if XACIATO is not commercially successful and our ability to raise additional capital or enter into other commercial collaborations could be impaired. See also the risks and uncertainties described under “Risks Related to Our Dependence on Third Parties,” above. 

The commercial success of Ovaprene, if approved for commercial sale, will depend on the degree of market acceptance of a hormone-free, monthly intravaginal product, clinical efficacy and safety of the product, including as compared to alternative contraceptive methods, pricing of the product, and the availability and extent of third-party coverage and reimbursement for the product, as well as other factors including Bayer’s marketing and sales efforts.

Today, there is a wide