Daré Bioscience could have a first-in-category product on its hands with its “female Viagra” offering, analysts at Dawson James believe.
The women’s health-focused biopharmaceutical company on Tuesday reported positive results from its Phase 2b RESPOND study evaluating its proprietary topical formulation of sildenafil (sildenafil cream 3.6%) as a treatment for female sexual arousal disorder (FSAD), a condition for which there is no Food and Drug Administration (FDA)-approved treatment.
As noted by the analysts, the exploratory endpoint for sexual desire demonstrated a statistically significant improvement from baseline to the eight-week mark after randomization in the intent-to-treat population who used sildenafil cream compared to placebo.
Based on the data from the study and the lack of an FDA-approved product for FSAD, the analysts wrote that “sildenafil cream has the potential to be a first-in-category product.”
They pointed out that market research indicated about 16% of women aged 21 to 60, or about 10 million women in the United States, are distressed from experiencing symptoms associated with FSAD, including low or no sexual arousal, and are seeking a solution to improve their condition.
“To put the market opportunity for an FDA-approved FSAD treatment in context, the prevalence of complete erectile dysfunction (ED) in men is estimated to be about 5% of men at age 40, increasing to about 15% at age 70,” they wrote.
In justifying their ‘Buy’ rating on the stock and US$3 price target, the analysts wrote that they expect commercialization of DARE-BV1, Daré’s vaginal gel treatment for bacterial vaginosis, in 2023.
Commercialization of Ovaprene, the company’s hormone-free monthly intravaginal contraceptive, is expected to follow in the United States in 2023 and in the European Union in 2025, with sildenafil cream expected to be commercialized in the United States in 2025.
On their price target, the analysts wrote: “We assume a 30% discount rate in our free cash flow to the firm, discounted earnings per share, and sum-of-the-parts models due to the risks associated with each product. This results in models that are equally weighted and rounded to the nearest whole number for a US$3 price target.”
Shares of Daré were trading at US$0.89 on Thursday afternoon.
Contact the author at emily.jarvie@proactiveinvestors.com
Follow her on Twitter @emilyjjarvie