Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 224

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 224
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 range of prescription and over-the-counter contraceptive options, including hormone-free options such as condoms, diaphragms, cervical caps, sponges, copper IUDs, spermicides and vaginal gels, as well as hormonal products such as pills, patches, vaginal rings, IUDs, implantable rods and injectables. In addition, multiple new methods of pregnancy prevention are in development, including hormone-free options, and some may be marketed in the U.S. before Ovaprene, potentially adding to the level of market competition Ovaprene will face, if approved. In surveys, women have said that the features they consider most important when selecting a contraceptive method are efficacy, ease-of-use and side effects. To have significant revenue potential as a new contraceptive product option, Ovaprene may need to demonstrate typical use efficacy (or the expected rate of pregnancy protection once the product is used widely under everyday circumstances) that approaches the approximately 93% typical use efficacy at 12 months of current FDA-approved non-implanted, non-injected hormonal contraceptive methods (pills, patches and vaginal rings). Clinical testing will also need to demonstrate that the product can be safely worn for multiple weeks. 

If Ovaprene receives regulatory 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 

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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