Replies to post #10630 on Innovus Pharmaceuticals Inc. (fka INNV)

[Biotech Pharmer]

You call it what makes you feel good. ANDA's do not take 3 years. That's why Damaj paid himself (Novalere Holdings) already. The horse is out of the barn. The ship has sailed. It's water under the bridge. The CEO has played a shell game.

[healthywelth]

This is from Syd YB. nice analysis but do your DD always..


Well, as a longtime holder of a lot of shares of this stock, I also wonder WHEN we'll see some some daylight here because we have been on the dark side for a while now. I also know that as demoralizing as that may be, better days are coming. There are several milestones on the horizon over the next six months so for those who just sold or are pretty dejected and have lost complete faith, I say please hang-in there for just six more months. We have Q3 launch of the (Hikma) FlutiCare, we have earnings report in mid-August, we will for sure have a thumbs up or down vote from the FDA on the (Novalere) FlutiCare and we have the possibility of making $10+ million in top line revenue by 12/31/17 and becoming profitable. Based on the last earnings call and the Q1 income statement, operating expenses were leveling-off so that's why there is a small possibility INNV can be profitable in 2017 as well as cash-flow positive. Clearly, this is a slight modification from the previous guidance when the CEO believed that he needed about $15M in revenue to be profitable but the company now believes it can be profitable with even $10M in top line revenue. The profitability piece is a critical milestone because a positive year-over-year EPS number will have a significant impact on INNV getting noticed by the larger investment community.
Even if the company does $10M in 2017, I will take that 100% improvement over the previous year. The best business performers in the world generally do not DOUBLE their revenues from one year to the next. Even if FDA rejects FlutiCare, $10M is not a bad performance from the previous year's $4.8M or so.
With respect to the anticipated FDA approval for the original FlutiCare (fluticasone propionate), I still believe this nasal spray will be approved albeit much closer to the November 2017 deadline. My basis for this assumption is that fluticasone propionate is not a complex generic drug and we have several (same form) allergy rhinitis nasal sprays approved and already on the market.

The above commentary is optimistic but also realistic and attainable in many ways.

So what are some issues that may derail INNV's progress?

The first is that we could have an outright rejection by FDA and that will certainly could be a blow because of the retail investor sentiment tied to "approval" of the original Novalere OTC drug.

The second issue (as someone pointed out a while back) is what will happen to the 24+ million shares Dr. Damaj (prematurely) gave to Novalere shareholders. If FDA rejects FlutiCare, not sure how they plan to undo the transaction?

Further dilution is a possibility but not likely. According to the Q1 income statement, the company has enough cash to operate and launch Hikma FlutiCare etc. There don't seem to be any leading indicators for a dilution at this time.

What if Hikma FlutiCare (which started sales effective July 1) is not able to compete with Bayer (ClariSpray) or Flonase and can barely capture any material portion of the allergy rhinitis market. The big boys have a huge marketing budget but INNV will tout its Beyond human platform to sell the OTC drug online to its millions of subscribers. We will see who wins this David and Goliath battle.

What if there is some serious internal strife and management issues that we are not privy to can also impact the company. Hopefully, that is not the case but always possible with any company.

What if Q2 results (coming out mid-August) are worse than expected and that can put their $10M revenue goal for 2017 in jeopardy.

So the above items are also a possibility and full well part of the story. And these scenarios are fairly common with most OTC equities. At the end of the day, my personal view based on my own DD is that my proverbial glass is "half-full" and that's why I will hang-on to my shares through the end of this year to see the drama unfold one way or the other. If there is no significant progress between now and Q1 2018 earnings report, I will be happy to fold my tent and move to something else.