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Home town is Houston. Good to see the post Eman. Great energy in the city. Two very deserving teams.
Lol, the dual alias Even as the future looks bleak for some. What a troll!
Finally got to listen to the replay of the bio conference. Odd to think that as Pascoe gave such an upbeat company update, that he knew the R/S was coming the next day. Unfortunately, he is very talented at delivering a message whether there is truth behind it or not.
The PPS will have to be way up there now for a break even. Certainly the institution that bought in during the most reason cash raise had to know this was coming. Denner must have known this was coming. What does Pascoe must have some plan in mind to recover the investments of those institutional investors. I'm sure shares issuance/dilution must be part of it. I am convinced he could care less about the retail investor.
What a mess! Fispemifine cut the jugular. Makes me wonder what the influence was to bring Fis to our little APRI...
I agree Eman, David was awesome. He would respond to an email every time and in a timely manner. He would return a call every time. I thought that he took an active role in providing feedback to Pascoe, and I noticed that several of the thoughts on investors mind, were often addressed in some form or fashion by management after you took a concern to David. I'm not sure why they ever made the switch...
I agree Eman, you don't drop that kind of change without confidence in the path moving forward. Interestingly, this time the investments are Vitaros based and not Fispemifine...and there is a lot more information about the market viability of Vitaros at this time than there was before. Granted the pps is in the basement, but millions invested are millions invested, that's not chump change...and like you said, Denner hasn't jumped ship yet either. The question is, what kind of return are the institutional investors looking for...I'm sure Denner is not looking for sub $1.
You have mentioned several scenarios that could play out between now and next year that could spur the price. I think that we will see things that build momentum...and if FDA approval is won, you will see a much different investment landscape.
Nice! Thanks guys. Good follow up.
Lol, I'll take em :)
And thanks for clarifying and posting the correct link :)
The first line finding is very encouraging. Thanks Eman.
Thanks Growth,
I agree. Even in this study, a year after Vitaros has been on the market, it seems that a pertinent question on a questionnaire to prescribing physicians would be to ask about patient retention. It is my hope that the 65-79% satisfaction rate suggested in this study, translates into repeat users. Also, it is my suspicion that as the product delivery methods are improved, RTD and such, that rate will continue to rise.
The recent dilution, though painful, is intentionally timed to preserve pps momentum moving forward, imo. With the chain of events leading up to and concluding with a successful Vitaros FDA approval, the cash raise to see the NDA process to its conclusion is now obtainable...without killing the momentum that several positive events in the near future, may garner for the pps.
I added to my position for the first time in a long time.
I was looking for information on Vitaros reviews in Europe and ran across this article in Sexologies - the European Journal of Sexual Health. Dated July 2016, it provides a brief overview of Vitaros success rates as viewed by prescribing physicians. English translation half way down the page...
http://www.journals.elsevier.com/sexologies
Summary
Introduction
This study was carried out to assess how Vitaros®, a year after its release on the market, is being used to treat erectile dysfunction and how both patients and doctors perceive this drug.
Method
Observations were made of 117 physicians (sexual medicine specialist, urologist, or general practitionners), to evaluate how Vitaros® is actually be used.
Results
Seventy-two percent of these doctors were satisfied with Vitaros® after having prescribed it. Sixty-five percent of the patients who took it were satisfied or very satisfied – a percentage rises to 73 % when the prescribing doctor takes has explained to patients the need to take several doses before judging results, and to 79 % among patients to whom doctors prescribe it as a first-line treatment.
Conclusion
Vitaros®, the most recent pharmacological treatment of erectile dysfunction, broadens the supply of therapeutic resources offered to patients. Its effects can be optimized by associating the prescription with relevant information and by prescribing it as a first-line treatment.
Very good to hear, perhaps DG will pull some strings for us :)
Eman, thank you for letting us know about DG. His wit and thoughtful posts will certainly be missed. It's my hope that he has the last laugh on this one...
Eman and others, thanks for all the posts. Always good to hear the viewpoints out there.
At one point Takeda and Sandoz believed in Vitaros enough to sign marketing agreements with Apricus. So what changed? Vitaros did not sell like they anticipated it to? The company told us many times that things were going better than expected. Yes, I have come not to believe what management says...unfortunate. Perhaps it was the lack in development of the RTD that pissed them off, and they decided that the return in volume vs. the hassle logistically of continuing with the cold chain, was not in their best interest. I know that Pascoe had mentioned to one of the members on this board that they (the marketing partners) were not happy with the delays in the RTD - whatever happened with the progress on the RTD by the way? They barely touch on it now. Did they take their eye off the ball when they were focused on Fispemifine or was the science team that far off on their understanding of the stability factors? Regardless, our first to market partners have opted out...
So with cash a crunch, a desperate need to generate positive data for US approval, it makes sense that Apricus would give up (roughly 5% in the agreements) 1/3 of their royalties to go with a smaller, hopefully more aggressive marketing partner in Ferring. This has never sounded like a winning move to me, but I guess when you have limited options, you need take the best course of action.
Shortly before this, the company managed to regain the rights to Vitaros in the US and negotiate 20% royalties (opt in) and upfronts with Allergen. Something I applaud the company for, and the main reason I have some hope for Apricus.
Moving forward I believe there is a lack of confidence in this management to execute. That, the missed guidance (often), failure of Fispmifine Ph2B, and non staggering sales of Vitaros in the EU, are obviously the culprits. Will US approval bring in new investors? In my experience, not a single person I speak with (on the subject) has even heard that there is a cream based drug for ED in existence...I don't really call it topical. I'm guessing at the very least, were it approved in the US, all those adds you see for the men's clinics that specialize in treating ED and such, will be advertising (and prescribing) Vitaros. Throw in some legitimate national level advertising, and new investors will clearly learn about Apricus.
So huge questions remain:
Can Apricus management execute?
Will Vitaros be approved in the US?
Most importantly in my mind, DOES VITAROS WORK? If it does, it will be hard to stop men from using it...
Still some potential here, though the track record is troublesome. Some execution is necessary. Awfully quiet management these days...
US market for V a different animal
Thanks wam3, still plenty of room for positive here...despite the negative view points often expressed on this board.
https://www.morningstar.com/news/globe-news-wire/GNW_6039664/erectile-dysfunction-drugs-market-size-will-be-worth-32-billion-by-2022-grand-view-research-inc.html
After the patent expiration of key drugs such as Cialis (tadalafil) in 2017 and Levitra (vardenafil) in 2018, other drugs such as Stendra/Spedra, Zydena (udenafil), and Vitaros (Alprostadil Cream) are expected to capture the market share during the forecasts period.
Apricus Biosciences Inc., Cristalia Produtos Quimicos Farmaceuticos Ltd., Bayer AG, Dong-A Pharmaceutical Co. Ltd., Meda Pharmaceuticals, Inc., Eli Lilly and Company, Pfizer, Inc., S.K. Chemicals Co. Ltd., and Vivus, Inc. are some major players of this market
Pondering Q's:
Who were the interested parties back in the day waiting on FDA ruling and approval of Flib, and was that the major sticking point?
Is exogenous testosterone the culprit when it comes to supplemental testosterone related health issues, and are elevated levels increased endogenously a safer alternative? Ref Fispemifine
Will Vitaros sell in a meaningful way, and when?
Money to operate the business?
No visible near term catalysts, long term a different story...need some good news unexpected.
The doldrums!
Execution!
The 8-k is posted on the APRI website. All proposals approved.
For the quarter ending December 31, 2014 Vitaros royalty revenue with the 1 quarter lag (Jul, Aug, Sept.) was listed as $36,000. At that time the following countries had launched:
UK - June 16 2014
Sweden - Aug 04 2014
Germany - Aug 18, 2014
For the next reporting quarter, the quarter ending March 30, 2015 Vitaros royalty revenue with the 1 quarter lag (Oct, Nov, Dec) was listed as $88,000. At that time the following countries had launched:
UK - June 16 2014
Sweden - Aug 04 2014
Germany - Aug 18, 2014
Belgium - Nov. 03, 2014
That is more than doubling the units sold from 1 quarter to next in my book...give or take based on the actual double digit royalty agreed upon with each partner. Of course, I agree that prescription refills and order refills will be a true test of the market, but we are being told that those refills are taking place. Additionally, I recognize that 2 country launches within the quarter ending December 31, 2014 were only driving sales for half of the quarter, but the fact remains, royalty growth more than doubled.
So we are 3 reporting quarters into this...the first one had negligible royalty stream because the launch in the UK was 2 weeks old. IR has said that a Vitaros revenue stream will be slow to build citing a new product to market in places that don't advertise drugs. I think it's fair to say that they were right, but also think it's fair to say that it's heading in the direction of growth.
This is in the very early stages...
As a follow up to something Eman posted a week or so ago, relative to a Tweet that referenced the words of the Majorelle Laboratories President (Guillaume El Glaoui)...that the France launch was just weeks away.
A new Vitaros Tweet posted 3 days ago by Charlotte&Charlotte (whoever that is?) included a picture of an article that was posted in L'Express...a French weekly news magazine headquartered in Paris. Since the article was posted as a picture, you can't cut and paste the text into Google translate. I typed the article into Google translate verbatim, and this is what the article said (Google Translation).
Note the time reference for the expected release of Vitaros in France, according to this article...April!
Just Out
an anti- impotence gel
It is expected in April and will be the first topical treatment said (which acts in the place where it is applicable) in matters of male impotence. This medication marketed by laboratories Majorelle has the same mode of action as intra-cavernous injections , but without painful needle bite practice in the penis. Simply apply a drop of gel on the meatus through a pipette. Its efficiency is comparable to that of oral Treatments , against its similar -indications, and fast action ( 15 to 20 minutes). However its duration is shorter : it acts as a two HOURS , against six or even twelve hours for tablets . Its price : from 12 to 14 euros per dose.
Well said Dave!
Thanks value. I added another chunk last week myself. Surprised no one has mentioned this yet.
During the fourth quarter of 2014, Apricus completed the development of the room temperature formulation of Vitaros, which is housed and delivered in a small, custom developed, disposable dispenser or "room temperature device." The initial production of Vitaros RTD to generate the required stability data required for marketing approval has commenced. The Company continues to expect its commercial partners to launch the Vitaros RTD in 2016.
Not really, the decision for reimbursement in France was not supposed to happen until December. If that happens anytime soon, you may see a launch sometime this month, if not, then the France launch may be pushed back until there is reimbursement, January? The sampling program is under way in France.
Happy Thanksgiving!
Nice volume! Thx RVL
I signed. Thanks Eman
Thanks DG
Where?
I'm still here with all my shares. Knew what the risks were each time I purchased. Lots of good discussion on the board. Going to hang around. Clarity is coming.
Was watching the NFL network 2 weeks ago during pre season games. A law firm commercial, advertising services to those that have taken Viagra and have suffered from melanoma, was aired. This is probably just the beginning of that campaign.
My interest in APRI has always been Vitaros. The market that APRI has set it's site on, and the royalties they account for in their plan, could very well be conservative compared to the actual market that they tap into, imo.
I'm sure this has been discussed before, but the answer slips my mind. Who covers the cost of the sampling? The marketing partner or Apricus? Does Apricus receive royalties for all product delivered, or just that which is commercialized? I ask because of the reference made to the sampling campaign mentioned in last weeks updates. I got the impression that the sampling campaign was/is significant.
Great news indeed! Vitaros now available in countries with a cumulative population of 150 million. Keep the launches coming!
Lol, that ought to do it...thanks DG.