MIAMI BEACH, FLA. – 12-10-2018 ( — Look, there are opportunities in the market that get overly publicized by often biased journalists, and then there are some that you need to dig to find. Aytu BioScience, in even another sense, is one of those …you’re lucky if you find it kind of stocks. And, for investors that listened to the LD Micro Main Event conference on Tuesday, or plan to hear the company presentation replay at, they will likely understand correctly what I mean when I consider investors lucky to get AYTU shares at these levels.

Even easier for some, many like to be delivered opportunity, so, here you go. At its core, Aytu BioScience (NASDAQ: AYTU) is a commercial-stage specialty pharmaceutical company focused on commercializing unique treatments that have the potential to revolutionize the standard of care in large medical areas, especially those areas in desperate need for more available and effective treatments. That’s a long description, but, everything in it is true.
In that endeavor, AYTU has acquired a portfolio of disruptive and novel products that target medically stagnant markets that are in need of an upgrade. The company hits these markets with potential best-in-class drugs, and when combined with the company’s visionary approach, AYTU is in the perfect position to capitalize on their products’ unique strengths to earn sizable gains in market share against its competitive alternatives. And, the prize is substantial, with the total addressable market of their portfolio estimated at over $7 billion. Hence, even incremental product penetration can mean significant revenue generation which adds to the premise that now is the time to get excited about Aytu Bioscience.

A Powerful Portfolio Of Potential Best-In-Class Drugs

One of the most valuable elements behind AYTU’s ambitious proposition is the management’s vision and ability to discover, acquire, and market novel treatments that have clinically demonstrated the potential to disrupt the current standard of care significantly. Investors have come to refer to AYTU as the “only” company because their top three drugs are the ONLY drugs that can meet certain designations. For instance, Natesto® is the ONLY FDA-approved non-injectable TRT treatment not required to have a Black Box Warning. Similarly, ZolpiMist® is the ONLY FDA-approved oral spray prescription that delivers the active ingredient found in Ambien®, zolpidem tartrate. And, Tuzistra®XR, AYTU’s newest acquisition is the ONLY codeine-based, FDA-approved, 12-hour antitussive product on the market that addresses cough and cold symptoms. Not to get repetitive, but there are more “only’s” about each of these compelling products which are why from a competitive perspective it may be only a short matter of time before the treating physicians change their prescription writing habits to the AYTU products. And, they should.

Natesto® Is The ONLY Nasally-Administered TRT

Natesto®, one of the company’s flagship products, serves as a prime example of how being the novel drug on the block can drive revenue generating opportunities for Aytu, and at the same time prove the best-in-class value that will separate it from its competitors. As it stands, Natesto® is the only FDA-approved, nasally administered TRT on the market, and again, the only FDA-approved TRT product getting sold that is not required to have that pesky Black-Box warning. Yes, that means that every other competitive product, Androgel®, Testim®, and Axiron® has the most severe of FDA warnings attached to the product, with many of the potential complications being quite severe. And, if that makes Natesto® better than Androgel®, Testim®, and Axiron®, a strong case for a best-in-class product emerges.

But, not only is Natesto® a likely best-in-class option because of its ease of dosing and safety profile, Natesto® is publishing data from its ongoing spermatogenesis study taking place at the University of Miami’s Department Of Urology. And, the results not ONLY make Natesto® an even better option, but it is showing its profile to be the ONLY TRT drug either on the market or in clinical trial that not only maintains normal semen parameters in males and not affect fertility, but it is showing its ability to treat patients with all the benefits of testosterone while at the same time preserving male fertility. Here’s a secret, this is a first of its kind result and one that should be taken seriously because the ramifications of owning a TRT asset that can preserve fertility will be a substantial one. This is huge because approximately 20% of men with Low T (2 million men or more) are still in their ‘family formation’ years, but these guys can’t be treated with testosterone.  Natesto® could own this population.  And, Aytu owns it.

But, there are two other “only” products in the portfolio.

ZolpiMist®: The ONLY Oral-Spray-Delivered Dose Of Zolpidem-Tartrate (Ambien)

As if one billion dollar market opportunity isn’t enough for an emerging company, consider the fact that AYTU has three opportunities. The second comes from ZolpiMist®, which is the only FDA-approved oral spray prescription sleep aid available on the market. ZolpiMist® has a targeted market, designed primarily for patients with insomnia characterized by difficulties initiating sleep – and patients that don’t get to sleep quick enough with tablets.

By design, ZolpiMist® is a fast-acting oral spray of zolpidem tartrate, the most commonly prescribed sleep aid and the same ingredient found in Ambien. However, like Natesto®, the treatment’s unique route of administration carries multiple benefits over its competition, in this case, Ambien.

ZolpiMist® does what Ambien® can’t provide- a more rapid onset of action through absorption in the oral mucosa, eliminating the time necessary for Ambien to metabolize through the liver. And, don’t underestimate another “only” characteristic of ZolpiMist®…it also serves a large market by simplifying dosing for those patients who have difficulties swallowing pills.

The reward for AYTU and shareholders can be huge. Consider this. If ZolpiMist® can succeed in earning just 1% of this almost $2 billion market opportunity, revenues of roughly $50 million in net revenue could be recorded in the Aytu accounting office. But, thinking bigger, like earning 2% or 5% makes the prospect of a blockbuster drug, regarding AYTU’s bottom line, an even more palatable proposition. But, while targeting the $3.6 billion just alluded to is great, AYTU has another drug. Of course, its an “only” drug as well. Even better, the combined three drugs target a combined market of roughly $7 billion!

Aytu Brings On Tuzistra®XR, With $5 Million From Armistice Capital 

The third and most recent addition to Aytu’s portfolio is Tuzistra®XR. Exclusively licensed to Aytu in early November 2018, Tuzistra®XR is the only FDA-approved 12-hour codeine-based antitussive. Very important to note, Tuzistra®XR had roughly 40,000 prescriptions written for the drug in 2017, so there’s a good chance that Tuzistra®XR can hit the ground running.

But, while we don’t have too much information about Tuzistra®XR just yet from the AYTU team, investors do know that Armistice Capital liked the opportunity enough to dedicate and invest $5 million in cash to accelerate the AYTU launch of the product. And, as investors heard during the LD Micro call, a complementary product toTuzistra®XR is winding its way through the FDA approval process and will likely add yet another novel product to the AYTU portfolio.

Tuzistra comes with patent protection, too. The prescription treatment is a patented combination of opiate-based antitussive codeine and chlorpheniramine, a histamine-1 receptor, and is intended to treat coughing and other upper respiratory symptoms in adult patients. Aligned with AYTU’s other “only” products, Tuzistra®XR strongly differentiates itself from similar suppressants in its field by being the only codeine-based antitussive product to offer a 12-hour delivery duration, relative to the short-acting 4 to 6-hour dosing duration of other available treatments. Better Relief, Fewer Doses, And Normal Routines Through Tuzistra®XR

Hence, by serving as the “only” known 12-hour codeine antitussive on the market, patients can substantially reduce the number of dosages required, can promote extended relief from cough and cold symptoms, and allow users to continue regular work and sleep schedules without needing to carry around and re-dose a prescription medicine multiple times per day.

Notably, investor chatter has been enthusiastically biased toward a big win for Tuzistra®XR. As soon as AYTU launches the product, investors may start to see more information and company updates as to how this product can lead to massive prescription writing increases from doctors who liked the drug in 2017. Now, with better marketing and a substantial cash infusion, Tuzistra®XR may inevitably crush those 2017 numbers and set the bar much higher. Investors will know soon enough.

Investors Should Like AYTU Now, Then, And Hereafter

No matter how pundits may slice and dice the facts, the truth is that with three, novel, proven-successful, and “only” type products in their portfolio, Aytu is arguably in a more excellent and enviable position than ever before. Managements innate ability to scope out and acquire products that can address significant unmet medical needs and improve upon the current standard of care has developed AYTU into an emerging drug company en route to commercializing all three of its novel treatments and win prescription pad attention.

Not only are the AYTU products each unique in their own way, but were also strategically selected by Aytu’s management to target billion-dollar-plus markets that have shown little willingness to upgrade current offerings. Thus, with an opportunity staring them down, AYTU took the lead and is bringing to market Natesto®, ZolpiMist®, and Tuzistra®XR, each bringing with them best-in-class potential to serve millions of patients over time.

Some investors focus purely on numbers and AYTU delivers there as well. The company has posted consistent and robust increases in revenue for consecutive quarters since 2017. AYTU is driving those increases, with Q3 2018 generating $606,000 and Q1 2019 closing with $1,431,000 in revenues, a 125% increase. And, with the recent addition of Tuzistra®XR, these figures are very likely to continue the upward trend. In fact, during the LD Micro call the CFO alluded to a potential gain of more than 175% in revenues in the coming quarter from Q3 2018. Relying On A Management Team With Vision And Proven Success 

Led by industry expert and CEO Josh Disbrow, who has built and sold prior mega-million dollar drug companies from the ground up, AYTU has a U.S. based sales force that deals with real doctors, real drugs and generates actual prescriptions. This is no start-up venture. Although the list for investment consideration can be extensive, perhaps just a few sentences are all that’s needed to bring an investor into learning more about the opportunities presented through an investment into Aytu BioScience:

Aytu has nearly $20 million in cash. Aytu has three “only” drugs with best-in-class potential. And, Aytu is trading at less than cash-value, a real disconnect from normal market valuations.

Putting it all together, now may be the best time to buy AYTU stock. One thing is for certain as well, this is the best of times for Aytu BioScience in it’s company history, so perhaps investors should join the journey. It’s often wise to follow the leaders.
This article also appeared on Soulstring Report.

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