Company: DARE
Filing Date: 2025-03-31
Form Type: 10-K
Source: 0001401914-25-000012
Chunk: 220

Company: Dare Bioscience, Inc.
Filing Date: 2025-03-31
Form: 10-K
Item: Item 1A
Chunk 220
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Our product candidates, if approved for commercial sale, will face intense competition and our business and operating results will suffer if we, or our commercial collaborators, fail to compete effectively. 

The pharmaceutical industry is intensely competitive and characterized by rapid technological developments. Moreover, the women’s health sector is very fragmented and highly competitive. We anticipate that our product candidates may compete not only with FDA-approved, prescription and over-the-counter, branded and generic drug products, but also compounded drugs, medical devices, dietary supplements, and cosmetics. We face and will continue to face intense competition from a variety of businesses, including large, fully integrated, well-established pharmaceutical companies and specialty pharmaceutical companies that already possess robust product portfolios and strong franchises in women’s health in areas in which we plan to compete, as well as generics manufacturers, compounding pharmacies and other drug compounding facilities, and dietary supplements manufacturers. In addition, academic and other research institutions are and could be engaged in research and development efforts for products in the therapeutic areas targeted by our product candidates. Many of our competitors or potential competitors, either alone or with strategic collaborators, have:

•much greater financial, research, technical and human resources than we have at every stage of the product development and commercialization life cycle;

•more extensive experience in designing and conducting clinical trials, nonclinical studies, obtaining regulatory approvals, and in manufacturing, marketing and selling prescription medical products; and

•approved products or product candidates in late stages of development for one or more of our target indications. 

Competitive products may be equally safe and as effective as our products, but sold at a substantially lower price. Alternatively, competitive products may be safer or more effective, more convenient to use, have better insurance coverage or reimbursement levels or be more effectively marketed and sold than our products.

Many of our product candidates, if approved for commercial sale, will compete with products that have already been accepted by the medical community and patients. If our product candidates fail to generate compelling clinical results or if patients and health care providers fail to adopt our products for their respective indications, their commercial potential could be adversely impacted or severely diminished. It is possible that the potential advantages of our product candidates do not materialize or that the approved prescribing information for our products does not describe expected features or benefits. We also expect to face competition from new products that enter the market over time. We are aware of products currently under development intended for the same indications as our product candidates. These competitive product candidates may prove safer, more tolerable, more effective, and less expensive, and may