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Thursday, August 11, 2022

A Close Look at Innovus Pharmaceuticals Inc (OTCMKTS:INNV)

Innovus Pharmaceuticals Inc (OTCMKTS:INNV) has formed a strong base at the $0.30 level in recent weeks after topping out at $0.663 in July. The stock was trading for as little as $0.028 8 months ago.

There is plenty to get excited about on INNV who recently announced their intention to up-list to the NYSE. INNV already owns an extensive portfolio of over-the-counter (OTC) brands that could become billion dollar revenue streams. They are also waiting to hear back from the FDA on their New Drug Application (ANDA) for FlutiCare that sold more than 177 million units in its RX form.

Innovus Pharmaceuticals Inc (OTCMKTS:INNV) is an emerging leader in OTC and consumer products for men’s and women’s health and vitality. The Company generates revenues from its lead products (a) BTH® Testosterone Booster, (b) BTH® Human Growth Agent, (c) Zestra® for female arousal and (d) EjectDelay® for premature ejaculation and has an additional five marketed products in this space, including (e) Sensum+® for the indication of reduced penile sensitivity, (for sales outside the U.S. only), (f) Zestra Glide®, (g)Vesele® for promoting sexual and cognitive health, (i) Androferti® (in the US and Canada) to support overall male reproductive health and sperm quality, (j) BTH Vision Formula, (k) BTH Blood Sugar, among others and eventually FlutiCare™ OTC for Allergic Rhinitis, if its ANDA is approved by the U.S. FDA.

INNV has established significant distribution channels in the US through Walmart, Target, Walgreen’s Drugstore.com, and many other known retailers. The company’s largest target market is allergic and non-allergic rhinitis – better known as “hay fever” or “stuffy nose” by the general public. The company’s FlutiCare™ active is the #1 nasal steroid prescribed by physicians and used by patients. After dispensing more than 177 million units since 2007, Innovus is seeking to secure an Abbreviated New Drug Application from the FDA to launch an over-the-counter option for those seeking relief from rhinitis symptoms. According to a report by Fierce Pharma, GSK’s Flonase OTC sold over $100,000M in a short period of time from its launch confirming the size of the market and the potential of FlutiCare™ if approved.

Female sexual dysfunction is the second market. The condition affects approximately 43% of women, compared to just 31% of men reporting similar difficulties. Whereas erectile dysfunction has become a $6 billion market, INNV’s Zestra® is the only clinically proven, commercially sold consumer care product with statistical significance in addressing these issues for women. The company has sold more than 12.5 million doses sold to date.

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One of the exciting aspects of INNV is FlutiCare, the leading nasal steroid recommended by physicians for the treatment of nasal congestion, sneezing, runny nose, and itchy nose which sold more than 177 million units in its RX form. The Company acquired the over-the-counter rights to FlutiCare early last year has been making its way through the lengthy approval process with the FDA.

INNV filed the over-the-counter Abbreviated New Drug Application (ANDA) for FlutiCare during the fourth quarter of 2014 which was accepted by the FDA for review. According to many sources the Company should hear back from the FDA on the ANDA within the next two months.

On October 3 INNV announced an exclusive licensing agreement with Seipel Group (SG) for the rights to market Urox® Formulation using the Company’s Beyond Human Platform.

Urox® is a specialized patented herbal supplement. It has been clinically proven to reduce urinary urgency, accidents and both day and night frequency in Overactive Bladder (OAB) and Urinary Incontinence (UI) patients. Innovus will market the product under the name UriVaRx™ using its Beyond Human Platform.

Under the exclusive agreement, Innovus Pharma will pay SG an upfront payment and will commit to a yearly supply of product. Innovus Pharma’s marketing goal is to triple the sales of the supplement from $1 million in 2015 to close to $3 million per year. Urox® has undergone multiple double blind and comparative trials in both male and female OAB and UI patients.

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Currently trading at a $27 million market valuation INNV had $8 million in debt, little assets and small but growing revenues. INVV is an exciting story in small caps; the Company already owns an extensive portfolio of over-the-counter (OTC) brands that could become billion dollar revenue streams. They also have established distribution channels through Walmart, Target, and Walgreen’s Drugstore.com and recently announced their intention to up-list to the NYSE. INNV is waiting to hear back from the FDA on their New Drug Application (ANDA) for FlutiCare that sold more than 177 million units in its RX form. We will be updating on INNV when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with INNV.

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Disclosure: we hold no position in INNV either long or short and we have not been compensated for this article.

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