Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 166

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 166
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 is approved; • the timing of market introduction of the product and availability of alternative treatments and products for the same indication; • the demonstrated clinical efficacy and safety of the product, including as compared to alternative products; • the terms of regulatory approval, such as any restrictions on the use of the product together with other medications, or required warnings in the product labeling; • the prevalence and severity of any adverse side effects associated with the product, including as compared to alternative treatments and products; • the convenience and ease of administration for patients, including as compared to alternative treatments and products; • the willingness of the target patient population and prescribing physicians to try a new product ; 83

• the effectiveness of the sales and marketing strategy and efforts for the product, including the success of efforts to educate the medical community and third-party payors regarding the benefits of the product; • the pricing and cost-effectiveness of the product, including as compared to alternative treatments and products; • the availability and extent of third-party coverage and reimbursement for the product; • the willingness of patients to pay all, or a portion of, the out-of-pocket cost for the product in the absence or insufficiency of third-party payor coverage and reimbursement; • unfavorable publicity relating to the product or products with the same or similar APIs, or favorable publicity about 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