Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Andy, at this point the ONLY thing that matters is FDA approval. I can never make heads or tails on the EU data. Eventually sales may take off. However, it is my opinion that EU sales will be dependent on FDA approval and sales success in the US. Yes, I said that right. FDA approval is everything, even success in sales in Europe and the rest of the world. Advertising in the US will make it to the rest of the world.
I am irritated that the NDA is being delayed. However, I am also absolutely convinced that Denner looked Pascoe in the eye and asked if he had turned over every stone to ensure that the FDA was on board and that Pascoe understood any possible concern the FDA might have before any submittal. Remember that the FDA issued their non-approval letter back in 2008. Eight years has passed with a lot of retirements at that agency and a lot of experience dealing with PDE5 concerns. There will be new eyes looking at the old data and summaries of old data. Having a "friendly" meeting with the FDA as opposed to a hostile one, even if it delays submittal by 60 days is worth it...so I am agreeing with Pascoe on his strategy even if it irritates me. FDA approval is the company's last chance to get out of a hole...and I think on a risk-reward basis it is a better bet than Fispemifene was.
One more thing. A lot of us suspect that if things go right with the FDA that Apricus will be taken over, sooner than later. That is also my expectation. Apricus does not have the wherewithal to become a commercial pharma. Apricus management knows that as well. That would be fine with me, at a higher share price of course. I really don't expect $5 a share. I certainly hope for more than a buck a share.
Those are my bottom line thoughts.
OC, my thoughts are on the other board.
Good and accurate list, Eman. As you point out, it looks like our best partners have not been Big Pharma. The strategy of Damaj from the beginning was to get Big Pharma on board for their credibility, experience and deep pockets to move the product and also, I think, Damaj's fear of being quickly taken over by a single Big Pharma.
I have always felt that Damaj's strategy was misguided and created competition that pitted one BP against another, none of them wanting to commit resources that could benefit a competitor. The other thing, of course, was the inability to advertise in the EU. PDE5s took off in the US precisely because of Pfizer being able to advertise Viagra for what all know is a HUGE indication.
I agree that IF the FDA approves, a buyout is the most logical option as Apricus is not in any way capitalized to market in the US. The odds should be in our favor for FDA approval for a whole host of reasons including approval in the EU with no reported safety issues, plenty of positive anecdotes on efficacy and no reported requests from the FDA for additional studies to address concerns that they had in 2008. The market is giving Apricus no/nada benefit for any of those reasons because Vitaros marketing never took off starting with the Abbott fiasco and lastly with the Fis failure. The Abbott, Takeda and Sandoz issues have nothing to do with the prospects for FDA consideration. But we will see.
Eman, I agree with your analysis. And Pascoe is following through. The Ferring deal that most of us anticipated will be his story for the next conference call with the NDA submittal next in September. As others here have pointed out, Ferring is hungry and aggressive. That is what we need.
Yes, there was an increase of 60K shares shorted from June 15. BFD. The June 30 figure was still second the lowest in the last 52 weeks. The point is that there was no big jump. There wasn't even a jump.
Mecosmo, same question to you, what are you looking at that tells you that there has been a "big jump" in the daily shorts. The June 30 number you cited was an increase of about 60,000 shares from the previous two week period. That's 60K out of 2.5M. Further the June 30 number was the second lowest short number in the last year. So I see just the opposite trend. Shorting is down...just what you would expect.
Carlo, what are you looking at that tells you that there has been an increase in shorting Apricus?
Agreed SL. Pascoe outlined what they needed to do. The major unknown in terms of timing is getting a new partner for the Sandoz territory...presuming that is the solution.
Getting access to cash takes that concern off the table.
I think getting access to cash is a good and needed move and consistent with the focus on Vitaros. However, since Fispemifene the market has had zero confidence in the company. To establish some confidence, the company needs to address/resolve the Sandoz situation so Vitaros sales can resume in Germany...and the company needs to submit the Vitaros NDA in September. The latter should not be seen as a binary event, but after Fispemifene the market is not giving Apricus any benefit of doubt.
I don't give a lot of meaning to the short interest figures reported every two weeks other than to look at trends and relative magnitude. It just doesn't make any sense to me that there should be a lot of shorting at penny levels...just the opposite.
Because I am not a trader, I wouldn't know what to do with L2 access. Regardless, I am much more interested in fundamentals.
If you can make sense as to why this company is selling at less than four bits a share when they have a product being sold in Europe and a reasonable chance for FDA approval in less than two years for a drug treating an indication (ED) that affects millions of men, I am all ears. I understand the disenchantment associated with the failure of Fispemifene, but it does seem to me that the current share price represents a significantly oversold condition. A high risk, of course. But high potential reward at these levels. But I thought that at a buck.
Could you expand on GSCO. Forgive my ignorance but I don't know what GSCO is, and if "it" is a market maker, what is the significance?
>I think this'll move because it seems like there's more than a few short right here down around mid to high thirties...
The current (two weeks ago) short interest was reported at just under 2.5M shares. This is a 52 week low. Now why more haven't covered at these levels is a mystery to me, but I don't see the shorted shares being much of a catalyst for an upward move.
On the other hand, submittal of a Vitaros NDA in September, or finding a better partner to replace Sandoz would be two good catalysts. And I agree that there is a lot of incentive by the large shareholder (Sarissa) to get the price above a buck for at least a couple of weeks.
Let's keep the focus here on Apricus. There are other message boards for discussions of politics.
I am as frustrated as any shareholder and we do need some good news to establish an upward trend. DG...moderator
Carlo, it is highly likely the company will have a conference call during the first week of August to discuss 2nd quarter results, indicate that they are on schedule to submit the V NDA in September, and provide a status on V sales. What I would also like to see is some indication that they are dealing with the Sandoz issue.
I agree and that is an interesting point. Just when will the company seek approval of RTD? Obviously no sooner than when the stability studies are done, but we don't know the projected end date for those studies. Obviously no sooner than the completion of the FDA review (and hopefully approval) of Vitaros. The only thing that is comforting to me is that developing an RTD is not rocket science by any means. But then again, I think the RTD should have been market ready at least two years ago.
My understanding is that the NDA will be based on cold chain because the EU experience with Vitaros is with the cold chain product and that EU experience will form the efficacy and safety arguments to be considered by the FDA. Therefore, even if RTD were ready, it would not be a good strategy at this point to put it before the FDA. Later, absolutely.
I don't know how much $$ it would take to get RayVa rolling, but it was a clear (and I think correct) decision to conserve all resources to get the Vitaros NDA submitted to the FDA.
The situation the company is in because of the FIS bet sucks, but FDA approval of Vitaros could be huge.
Hey MG,
The company is trying to partner RayVa in the EU. However, to conserve cash, the company is holding off with the next clinical trial until it has that partner. The Vitaros NDA submission WILL happen in September. I am not sure about the RTD status but I know that the NDA will be based on the cold chain product with a little more leeway than three days out of the fridge. RTD, of course, has nothing to do with the DDAIP/Alprostadil "formulation," but CK has never been accurate on facts. I hope by this fall that the company has a replacement for Sandoz to get Germany and the rest of Sandoz's markets back into play. That should be the end of the EU issues.
The notion that the company will declare BK is laughable. Every microcap biotech has a run-out-of-cash date, and that date is always in the near term. However, cash is almost always available...and Denner will not allow "his" company to go BK for a few million dollars during the time that the FDA considers approval of Vitaros.
CK should go back to eating those sour grapes he bought when he also bought Apricus at $5.50 a share.
Oh Carlo, you are welcome to trade your Apricus shares 1:2.4 for Innovus shares and you get Bassam as a bonus.
Pascoe bet on Fispemifene along with Denner and including the rest of us that didn't sell. We all lost that bet. Pascoe had no insight that Fispemifene would fail. Do you now want Pascoe to chase OTC drugs like Bassam is doing? Or should Pascoe cut staff and concentrate on fixing the Sandoz problem and getting the FDA to approve Vitaros. Pascoe is doing exactly what he should be doing at this point.
If Bassam does well with Innovus, he can try to buy back Apricus. I am sure he would love to do that.
Thanks Mecosmo for contacting IR and posting. Takeda was replaced by Ferring who seems eager to start marketing Vitaros somewhere now that they have the Latin America territory. The words Beck used seem to imply that a replacement of Sandoz with another company like Ferring might be in the works. Since Vitaros is still being prescribed where it is available, there is no reason to believe that there is an efficacy problem, just a batch quality problem that Sandoz is hung up about for some reason. Hardly a reason for new clinical trials. But believe what you will.
Hentied, what leads you to believe that the company "may very well be in default of the 10 million credit facility right now"? If that were the case would it not be relevant information that would need to be disclosed? If the company were in default, would it really be to the advantage of the debt holders to call the debt? I think not.
But really, what is your point for posting? Are you happy that you sold out, if that is what you did, and are therefore making the case for your getting out? Are you trying to figure out if you should buy at these levels? Or are you posting because you enjoy irritating posters who are long?
Nobody that I recall challenged your decision to sell, if that is what you did. But you seem to want to challenge the decisions by some to hold or buy at these levels. Again, so why are you posting?
Still can't get over the fact that Denner supported reappointing Kleanthis to the board huh? And Pascoe is still the CEO. What happened to your repeated predictions about Pascoe's demise? Your conclusions that "repeat users are no longer using Vitaros" doesn't make sense grammatically and there is no evidence to support that statement even if it made sense. Throwing out numbers is not math, it is garbage. But that is what we have come to expect from someone who bought shares at $5.50 when Damaj was the CEO and can't get over it.
Pascoe did switch the company's focus to Fispemifene, until it failed in a Phase II clinical trial. What else? What do you have to support your claim that Pascoe changes directions every 3-4 months or that he jumps from one compound, one treatment, one idea to a different one?
Those here who think that Pascoe is getting paid too much at this point in time, I totally agree. He placed and lost a bet (Fis). There should be accountability associated with losing that bet, even though there was no guarantee that the Fis trial would turn out positive.
The above notwithstanding, I do think Pascoe is taking all the steps he should be taking to maximize the company's assets. And he started taking those steps immediately after the Fis results were out. He is cutting costs by reducing personnel and sidelining non-Vitaros projects (RayVa) to focus all resources on getting the Vitaros NDA submitted to the FDA in September. I have to believe he is working to resolve the Sandoz issue and that will greatly improve royalty revenues. If Pascoe were not taking the above actions, then I would agree with those who would fire him. But he is taking exactly the right actions, so I support him.
Also importantly, I think Denner will support the company until the FDA decision because it is totally in his interests to do so.
Again, at this point the company's total focus is the FDA's decision on Vitaros...and we should have that decision towards the end of the first half of 2017, in about a year from now. I can wait with Pascoe at the helm, and probably average down a little more.
As I recall there was an issue with the quality of one of the commercial batches of Vitaros that was shipped to Sandoz. I am sure the issue with that batch has been resolved because the other partners continue to receive and to supply/sell Vitaros.
Hentied, the company's plan is pretty straight forward. Cut operating costs to the bone. Generate cash from royalties along with licensing upfront money from remaining markets and including RayVa. I expect the Sandoz situation will be resolved one way or another but sales continue in France, Italy, Spain and the UK (the latter with Ferring). I would hope that a Denner would step up to the plate if the company was short a few million.
The company's focus is on getting the NDA submitted (we will know if they submit in September and shortly thereafter if the FDA will grant a 6-month review). The FDA decision on approval will be a game changer. If the FDA approves, we have a new game. If not, the company will be sold for pennies, if that.
That is it. We don't need to rehash Fispemifene any further. The company (and Denner) made a bet and lost. I was perplexed by that bet but went along for the ride. That is the risk of clinical trials and investing in microbiotechs. Most of those trials do not result in approvals. FDA consideration of Vitaros might be different because of the approvals in Canada and the EU and the fact that it has been prescribed for a couple of years with no (to my knowledge) safety or efficacy issues.
If you just want to vent, get it out of your system.
>>Did anyone catch how many units were sold 1Q<<
Actually, what is reported are royalty payments, not units sold. First quarter results are reported in the recent 10Q that is available to all at sec.gov.
So why not break it down for us instead of just throwing out a dubious question without any background or context? What is the timeline for FDA approval? How much cash do we have now? How much cash will we need considering the operational budget cuts the company will be making and which they reported over a month ago? Then what is the bottom line in terms of cash needs? What are the expected revenue streams? What are cash-raising options if the expected revenue streams will fall short of the company's needs?
If you want to know the possible risks of investing in Apricus, the 10Q clearly lays out all the risks, as do 10Qs for every company listed. For example, there is no assurance that Apricus will raise the money needed to enable the company to file for FDA approval of Vitaros. If you are uncomfortable with that risk, sell and move on. If you are an investor, you should understand that you are taking a risk and that investing in micro-biotechs like Apricus is much more risky than investing in companies like say Apple, or than keeping your money under your mattress for that matter.
It sounds to me after reading your posts that you are nervous about your investment. After all, Apricus is now trading at its multi-year low. Why not sell and move your money to a less risky investment? Or do you post just to try and make others nervous?
BTW, it is "Vitaros" not "Vitaroes."
Good move, I think. Use the opportunity to focus on the thing that is important right now, the US ED market anticipating the submittal of the NDA for Vitaros with the FDA.
Hey MG, I guess I just don't see Denner, or even one of his buddies, wanting a BOD seat on a company with a $30M market cap.
I suppose it is possible that RTD could be completed this calendar year, but I think as Eman and Aprilov reported, it is the cold chain version that will be submitted for FDA approval.
So far we really don't know how RTD will roll in terms of getting approved in Canada, the EU, or by the FDA. All we got from the April update was, "...Continue Vitaros delivery device improvements..."
And from the 10K on RTD: "We plan to perform the necessary equivalence and stability studies to market Room Temperature Vitaros® in Canada, Europe and other future-approved territories, and to seek to increase the shelf-life over time."
I am thinking RTD (or RTV) is not exactly on the hot burner.
That none of us are happy with the share price is understatement. However, the current share price has everything to do with the failure of Fispemifene in a blinded clinical trial...and everything to do with those shareholders who thought that Fis was the future of Apricus and who are now selling.
What could Pascoe have done differently? Yeah, he could have not made the Fis bet and have not taken that risk. But plenty here (well at least some) applauded the Fis move and its potential. To be sure, if the Fis trial had great results, that would have been great and Pascoe would have been a hero. But that Fis failed is hardly unusual in the biotech world and the failure of Fis was hardly Pascoe's fault. Again, the Fis failure is what has driven the price down.
I oppose any bonus that is not tied to a performance measure so I would eliminate those RSUs. I am OK with bonuses tied to FDA approval of Vitaros in the US as that is the future of the company. Period. I agree with cutting base salaries severely until after FDA approval, if that happens. Placing the Fis bet that didn't pay should have consequences.
As to the board, I am ambivalent. I didn't think Diedre added any value so I am ok with her resignation. We could probably stand to lose another board member. They all obviously bought in to the Fis bet. Again, the future of the company is FDA approval of Vitaros. Period.
Aprilov, you need to think about breaking the grandkids' piggybank and picking up some more shares for about four bits apiece. I did last this last week. Its only money. : )
Very nice work Aprilov and Eicoman.
Awkward, I agree. I read that half will vest on January 1, 2018. The other half will vest when the FDA approves Vitaros IF that happens before December 31, 2018. IF Vitaros is not approved or if it is approved after that date, they do not get the second half of the RSUs. Am I misreading it?
Note that they are now predicting/hoping that they get FDA approval in 1H2017, so that is at least 18 months before the December 31, 2018 vesting date.
I have wondered the same as to why they don't proceed with RayVa since it can't be a high cost trial. My guess is that they are trying to make a point with investors. That the company is serious about cutting costs and making Vitaros their number 1,2 and 3 priority. Whether that is pennywise and pound foolish remains to be seen.
I think we can all agree that RayVa is small potatoes. Further, as Aprilov points out, FDA approval of Vitaros will open the barn door for DDAIP. And Vitaros has the quickest pathway for DDAIP recognition. That is my two cents.
You brought up the lack of "plans of investment in increased manufacturing." Why? The 10K states:
"Vitaros® is currently manufactured by Therapex, a division of E-Z-EM Canada Inc., a wholly-owned subsidiary of Bracco SpA in Italy (“Therapex”) and by Groupe Parima, Inc. Our third-party manufacturers are subject to numerous regulations, including Good Manufacturing Practices, (“cGMPs”), FDA regulations governing manufacturing processes and related activities and similar foreign regulations. Both of these manufacturers are located in Canada and are capable of providing commercial product for our partners." (emphasis added)
So what is the issue with manufacturing capacity?
I didn't say I was a happy camper. I'm not. But let's stick to the facts. I don't think the company can reach profitability in a year by increasing product sales hand over fist. However, the company's commitment that it will reduce operating expenses by 60% in 2017 is well within their control. The company stated that it will submit the NDA by end of 3Q16. That is not a high bar. After that it is in the FDA's hands and they have review timelines.
PDubious, I don't buy the negativity. First, where do you get 19 months? The end of 1H2017 (for an expected FDA decision) is 14 months from now. During the period from now until then, the April 6 update lists positive events including submission of the NDA to the FDA, ten more expected country launches, and cost cutting that is expected to achieve company profitability in 2017. The latter is just with EU sales.
So I agree that the current share price sucks big time as a result of those who bought (and then sold) with the notion that the company was only about Fispemifene. But that wasn't and isn't the case. And the long term debt of $9M is actually pretty small. The company's prospects are not that bad, particularly if the FDA gods rule favorably in about a year. And again, no additional clinical trials are expected.
"Potential (FDA) approval (of Vitaros) in 1H2017"...that according to the company. In other words, a decision expected in about a year from now. Note, "no additional clinical studies expected" according to the company's recently updated company presentation.
Good article PuuliTuku. Of course, that article is now over two years old so hopefully the Ferring agreement with Celesio as its wholesaler in the UK has worked out.
Ferring has licensed a rather large, if not huge, territory in Latin America. Perhaps the silver lining here is that Ferring can get its feet wet in actually marketing Vitaros as it seeks marketing approval in Latin America. Admittedly that is the cup is half full view.
PuuliTuku, here is the explanation. Back in 2012 the company adopted a Long Term Incentive Plan that included awarding stock options as Restricted Stock Units to the top officers of the company. Pascoe, for instance, will receive 350,000 shares. But, here is the footnote on that SEC filing of April 25, 2016:
"Award of 350,000 Restricted Stock Units ("RSUs") under the Issuer's 2012 Stock Long Term Incentive Plan with half of the underlying shares vesting on the Company's receipt of marketing approval of Vitaros in the United States by the Food and Drug Administration on or before December 31, 2018 and the other half of the underlying shares vesting on January 1, 2018, subject to the Reporting Person's continued employment or service to the Issuer through such date."
So, these shares do not cost the officers anything, but are not vested yet. Half will be vested (in other words, exercisable) when the FDA approves Vitaros (which the company hopes will be in early 2017) and the remaining half will be vested on January 1, 2018. I don't know if Barbara Troupin's restricted shares will be accelerated so that she gets her shares when she leaves next month.