Company: DARE
Filing Date: 2025-04-24
Form Type: ARS
Source: 0001401914-25-000018
Chunk: 184

Company: Dare Bioscience, Inc.
Filing Date: 2025-04-24
Form: ARS
Chunk 184
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 potential of our products may not be realized, which could have a material adverse effect on our business, financial condition, results of operations and prospects. Risks Related to Section 503B Compounding We plan to generate revenue from sales of our proprietary Sildenafil Cream formulation produced by Section 503B-registered outsourcing facilities, but we have no experience in this line of business and may not be successful in our efforts. One aspect of our business strategy is to enter into licensing arrangements with outsourcing facilities through which we can generate revenue from sales of our proprietary Sildenafil Cream formulation produced by those outsourcing facilities under Section 503B. We have no experience in the compounded drugs market and we have never entered into arrangements with outsourcing facilities. We will be required to successfully identify and enter into satisfactory arrangements with one or more outsourcing facilities, and no assurances can be given that we will be successful in doing so on commercially reasonable terms or at all. Even if we are successful in this regard, we may not generate sufficient revenue to recover our costs. Establishing such arrangements could be expensive and time consuming, disrupt our other operations, require significant capital expenditures and distract management and our other employees from other aspects of our business. We will be reliant on Section 503B-registered outsourcing facilities to produce our proprietary Sildenafil Cream formulation, and their failure to adequately perform their obligations could harm our reputation, business and financial condition. If we are able to enter into arrangements with one or more outsourcing facilities, we will be reliant on them to compound and distribute our proprietary Sildenafil Cream formulation and to comply with applicable statutory and regulatory requirements, including FDA's cGMP regulations and related FDA guidance for drugs compounded at outsourcing facilities. We will also be reliant on suppliers that supply sildenafil citrate to the outsourcing facilities. We will not control or direct the compounding or distribution process used by these parties, and we will have no control over their ability to maintain adequate quality control, quality assurance and qualified personnel. These arrangements also involve other risks, including: • the inability of third parties to consistently meet product specifications and quality requirements; • delay or inability to procure or expand sufficient manufacturing capacity; • issues related to scale-up of manufacturing; • costs and validation of new equipment and facilities required for scale-up; • third parties may not be able to appropriately execute necessary manufacturing procedures and other logistical support requirements; • third parties may fail to comply with cGMP requirements and other FDA or other comparable regulatory requirements; • breach, termination or non-renewal of agreements in a manner or at a time that is