Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 222

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 222
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 to what other available products have demonstrated.

Additional marketing and educational efforts may be required to introduce a new branded prescription medical product in order to overcome use of generic products, compounded drugs and dietary supplements and gain access to reimbursement by payors. If we or a commercial collaborator cannot introduce a product at the desired price or gain reimbursement from payors for the product, or if patients opt for a lower cost generic product, compounded drug, or dietary supplement rather than pay out-of-pocket or a higher co-pay for our product, our sales revenues or royalties and other license fees, as applicable, will be limited and we may never become profitable.

Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would negatively impact our business.

The commercial success of any product we develop and bring to market, or is marketed by a licensee, will depend significantly on the broad acceptance of the product by physicians, patients, and others in the medical community, as well as, in many cases, third-party payors. The degree of market acceptance of our products will depend on several factors, including:

•the indication for which the product 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 ;

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•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