ORLANDO, Fla., March 16, 2016 (GLOBE NEWSWIRE) -- With the M&A activity in the biotech and pharma sector heating up as large and mid-size pharma target smaller companies to increase growth and revenue, new interest from the investing public should follow. Companies with unique product offerings, retail presence, sales and revenue would likely command increased attention in the market. Specifically, products that address female sexual health and wellness could draw heightened interest in a category that many project to see tremendous growth with a projected 6 billion dollar market and 43% of women affected,1,2.
The female sexual dysfunction (FSD) market has intensified with the drug Addyi approved by the FDA for a subset of the FSD market called HSDD. Addyi’s maker, Sprout Pharmaceuticals, was acquired by Valeant for $1 billion validating the large market size of this indication3. Female Sexual Interest/Arousal Disorder (FSI/AD) is the most common form of female sexual dysfunction. FSI/AD is a diagnosis that combines two previously distinct disorders, hypoactive sexual desire disorder (HSDD) and female sexual arousal disorder (FSAD) 4.
While men have had Viagra (sildenafil) made by Pfizer, Cialis (tadalafil) made by Eli Lilly, and Levitra (vardenafil) made by Bayer to address their sexual dysfunction issues for about a decade, finding a solution for women's woes has been more complicated. Yet the market for female sexual dysfunction drugs is believed to be larger than the market for male sexual dysfunction treatments (estimates close to $6 billion), since the percentage of women with FSD between the ages 18 and 59 (43%, according to studies by Edward Laumann and colleagues between 1999 and 2009) is higher than that for men (34%). Practically speaking, these assumptions appear to be partially validated by the acquisition of Sprout Pharma by Valeant for $1billion.
Other companies are deeply entrenched in the female sexual dysfunction market with a surprisingly large presence on store shelves already. While Addyi garnered a tremendous media cycle because of its nickname “female Viagra,” it joins a market already populated by others trying to improve the female sexual experience.
One such company is Innovus Pharmaceuticals (OTCQB:INNV) which enjoys shelf space in thousands of stores including major retail such as Walmart, Kroger, Pathmark, Drugstore, Meijer and others with an array of proprietary products for Female Sexual Dysfunction. Notably, Innovus expanded their presence in the FSD market with their acquisition of an over the counter product called Zestra. Zestra is commercially available in several countries and is a patented topical mix of essential oils with two double blind placebo controlled clinical studies in 278 women in the U.S. showing statistical increases in arousal and desire in women suffering from FSI/AD. It is NOT a drug and is considered a cosmetic in the U.S. Interestingly, Zestra has gone through the same trials that several of the drugs in development went through including Addyi. From the published clinical data of Apricus’s Femprox, Sprout’s Addyi and Innovus’s Zestra, Zestra has a comparable or even better response on the FSFI score for arousal and desire, satisfaction and it is by far the safest product, at least according to the published clinical data. In addition, Zestra is the only product that added consumer scores to their clinical trials and assessed partner’s responses5,6,7.
Additionally, Innovus just boosted their near and potential long-term bottom line by acquiring the assets of Beyond Human, LLC, a company known for its natural Testosterone Booster supplement “Beyond T Human” and its natural Human Growth Agent HGA® among others.
In 2014 alone, Beyond Human posted $1.3 million in gross revenues and approximately $300,000 in net profits and in 2015 it tallied $2.2 million in gross revenues and approximately $400,000 in net profit. Following the acquisition by Innovus, those top and bottom line numbers are now headed to future Innovus Q’s and K’s.
Increased revenue numbers, especially for a company with brand equity and retail relationships that Innovus already has in place are always intriguing. It could be argued that the expanded footprint in retail with Beyond T now under roof and its revenue accretive to Innovus’s growing revenue pattern will further help Innovus attract attention from the deal makers in the industry.
At the very least, it gives Innovus a growing presence in a fast-growing industry.
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- Laumann, E.O. et al. Sexual Dysfunction in the United States: Prevalence and Predictors. JAMA, Feb. 10, 1999. vol. 281, No. 6.537-542
- deKadt Zestra quantitative Consumer Study, October 2009
- Valeant Pharmaceuticals (VRX) public filings
- Diagnostic and Statistical Manual of Mental Disorders, Fifth edition (DSM-5), 2013
- Efficacy and Safety of Alprostadil Cream for the Treatment of Female Sexual Arousal Disorder: A Double-Blind, Placebo-Controlled Study in Chinese Population, J Sex Med 2008;5:1923–1931
- Randomized, Placebo-Controlled, Double-Blind, Parallel Design Trial of the Efficacy and Safety of Zestra® in Women With Mixed Desire/Interest/Arousal/Orgasm Disorders. Journal of Sex & Marital Therapy, 36:66–86, 2010.
- Efficacy of Flibanserin in Women with Hypoactive Sexual Desire Disorder: Results from the BEGONIA Trial. J Sex Med 2013;10:1807–1815
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Innovus Pharma's Forward-Looking Safe Harbor: Statements under the Private Securities Litigation Reform Act, as amended: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company, including, but not limited to, receiving patent protection for any of its products, to receive approval or meet the requirements of any relevant regulatory authority, to successfully commercialize such products (Zestra®, Zestra Glide®, EjectDelay®, Sensum+® , Vesele® and Androferti®) and to achieve its other development, commercialization and financial goals, whether the new distributors will continue to successfully market and sell our products. Readers are cautioned not to place undue reliance on these forward-looking statements as actual results could differ materially from the forward-looking statements contained herein. Readers are urged to read the risk factors set forth in the Company's most recent annual report on Form 10-K, subsequent quarterly reports filed on Form 10-Q and other filings made with the SEC. Copies of these reports are available from the SEC's website or without charge from the Company.
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Source: Emerging Markets LLC