Company: DARE
Filing Date: 2025-11-13
Form Type: 10-Q
Source: 0001401914-25-000050
Chunk: 97

Company: Dare Bioscience, Inc.
Filing Date: 2025-11-13
Form: 10-Q
Item: Part I, Item 2
Chunk 97
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 Sildenafil Cream. We expect to have DARE to PLAY Sildenafil Cream to become available by prescription in the U.S. in December 2025 and to begin recording revenue from sales thereof in the fourth quarter of 2025, however, we do not expect the amount of such revenue, if any, to be material during 2025. Because we are in the early stages of executing against our Section 503B compounding strategy and, as an organization, we have no experience in or infrastructure for commercializing products, the amount of potential revenue we may generate during 2026 remains uncertain. We anticipate needing to invest no more than $1.0 million to launch DARE to PLAY Sildenafil Cream in 2025, which has been and will be utilized to support a 503B-registered outsourcing facility with technology-transfer activities specific to DARE to PLAY Sildenafil Cream, activate an awareness campaign, and facilitate access to DARE to PLAY Sildenafil Cream as an option for providers and women. 

DARE to RECLAIM™ estradiol progesterone intravaginal ring 

We are also taking action to bring our estradiol progesterone intravaginal ring to market under Section 503B. The compounded product will be branded as DARE to RECLAIM estradiol progesterone intravaginal ring. We are targeting to have DARE to RECLAIM estradiol progesterone intravaginal ring available, and to begin recording revenue from sales thereof, in early 2027. Because we are in the early stages of executing against our Section 503B compounding strategy and, as an organization, we have no experience in or infrastructure for commercializing products, the amount of potential revenue we may generate during 2027 remains uncertain. There are no FDA-approved products that provide estradiol and progesterone together in a non-oral monthly form.

Consumer Health Products - DARE to RESTORE™

We are also working to bring to market a line of consumer health products branded as the DARE to RESTORE family of products, designed to support vaginal microbiome balance. We have sourced vaginal probiotics from Europe that we are targeting to make available in the U.S. in the first quarter of 2026. 

When we use the term “consumer health products,” we refer to consumer health products that can be obtained without a physician's prescription, unless the context otherwise requires.

Similar to our plans with respect to our Section 503B business strategy, we do not plan