Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 226

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 226
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 physicians, patients, third-party payors or others in the medical community necessary for commercial success, which would negatively impact our business.” If we or a commercial collaborator are not successful in increasing awareness and understanding about FSAD and Sildenafil Cream, the market potential of Sildenafil Cream will not be realized. Women who experience low or no genital arousal may be hesitant to seek treatment due to stigma and embarrassment associated with sexual health issues, lack of understanding of normal versus abnormal sexual functioning, or lack of awareness that FSAD may be treated with medication. Health care providers may be hesitant to prescribe Sildenafil Cream for many reasons, including lack of understanding or experience with female sexual dysfunction in general and FSAD in particular, lack of experience with any product approved to treat FSAD, or perceived lack of clinical evidence of the safety and efficacy of Sildenafil Cream. Women may also be hesitant to use Sildenafil Cream for many reasons, including the lack of experience with any product designed to treat FSAD, concern over potential side effects, and the out-of-pocket cost of Sildenafil Cream, particularly if it is not covered by insurance. Currently, third-party payors such as government health care programs and private insurance companies often do not cover products prescribed to treat female sexual dysfunction disorders. If Sildenafil Cream is not an affordable option for a significant segment of potential users, the ability to build a commercial market for Sildenafil Cream will be significantly impaired. 

In addition, FSAD is a condition that impacts women of many ages, including older and elderly populations. We have not yet thoroughly studied the topical or clinical pharmacology of Sildenafil Cream in different patient 

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populations, and sildenafil, the active ingredient in our drug candidate, has not been tested over long periods of time in older or elderly women. Older or elderly women may react differently and adversely to Sildenafil Cream than younger populations. We expect our pivotal Phase 3 clinical trials of Sildenafil Cream will be conducted in a premenopausal population. Therefore, we expect initial FDA approval of Sildenafil Cream, if received, to be limited to premenopausal women. Should Sildenafil Cream not be studied in older or elderly women, or, if studied in those populations, should it show increased risk of adverse reactions, or signs thereof, in older or elderly women during clinical development, the potential market for Sildenafil Cream could be significantly limited, which could have a material adverse impact on the value of this program. 

The commercial success of DARE-HRT1, if approved for commercial sale, will