Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 168

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 168
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 approval, its commercial success, or the success of any other future contraceptive product we develop, including our current early clinical-stage and pre-clinical stage candidates, will depend upon the contraceptive market and market acceptance of an alternative method. Factors expected to impact broad market acceptance of a new contraceptive product include those discussed above under "Our product candidates may fail to achieve the degree of market acceptance by physicians, patients, third-party payors or others 84

in the medical community necessary for commercial success, which would negatively impact our business," as well as: • demonstration of minimum acceptable contraceptive efficacy rates; • perceived safety differences of hormonal and/or non-hormonal contraceptive options; • competition from new lower dose hormonal contraceptives with more favorable side effect profiles compared with higher dose hormonal contraceptives; • preference for a monthly format product over contraceptive products to be taken daily or used in the moment; • preference for an intravaginal product over other formats such as pills, patches, injectables and condoms; • generic contraceptive options, including generic versions of the hormone-containing intravaginal product NuvaRing®; and • the effects of changes in health care laws and regulations on third-party payor coverage (including the birth control coverage mandate) and reimbursement and out-of-pocket costs to patients. If one or more of these risks occur, it could reduce the market potential for Ovaprene, or any other contraceptive product we develop, and place pressure on our business, financial condition, results of operations and prospects. Under our license agreement with Bayer, provided the license grant becomes effective, Bayer will have exclusive rights to market and sell Ovaprene in the U.S. Accordingly, the potential value of Ovaprene to our company may be highly dependent on the efforts and activities of Bayer. Should Ovaprene fail to generate compelling clinical safety and efficacy data, the license grant under our agreement with Bayer may never become effective. Even if Bayer elects to make the license agreement effective, Bayer has significant discretion in determining the resources that it will allocate to commercialization of Ovaprene and Ovaprene’s commercial success may be limited, in which case our business, financial condition, results of operations and prospects could suffer significantly. The commercial success of an FDA-approved Sildenafil Cream product will depend on the availability of alternative treatments and products, the effectiveness of the sales and marketing strategy and efforts for the product, including the success of efforts to educate women and their health care providers about FSAD, and the availability and extent of third