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It appears that all that is needed to finish this up is final government action on the HAS Commission's recommendation. This is much like the FDA acting after one of its advisory committee's has given its recommendation. Hopefully, France acts more quickly than the FDA usually does....
Carlo, thank you for the minutes. When I translated the votes it seems that last June the Commission voted "insufficient." This time the vote was for sustained low benefit. Is that not a vote for 15% reimbursement?
Oldcoach, you and Carlo have my vote on that.
If the feedback from patients to physicians is favorable, then I think those physicians will broaden their recommendations to their PDE5 patients...or PDE5 patients will ask for the new drug on the block. We are still only dealing with the Brits and the Germans as large markets.
But I agree, the PDE5 market is on the table. The company has been reluctant to push in that direction, but it is probably a matter of needing to establish a positive experience with physicians and their patients who don't benefit from PDE5s first.
Carlo, the reference I saw for Internet pricing (ExpressPharmacy) was more like $24 USD per dose. However, I think the Apricus royalty is based on the wholesale price to the partner, I thought more like $12-$15 USD per dose. I may be wrong, but that is what I recall. Eman probably has a better recollection.
Well at least France is not "dead." ; )
Social, I tend to agree with your assessment. My hope is that the France launch (which is well baked in), at minimum, helps secure a price floor around $2 (or a little higher). A France launch (followed by Spain) will certainly help the confidence level of existing retail owners.
While Fis is a much bigger fish, RayVa is closer to being in the net by virtue of lower trial costs, a shorter timeframe to get clinical trial results, loads of experience with alprostadil and DDAIP, and the work that Dr. Irwin has done and published. So I view RayVa news as being more important in the short term.
Fis is harder for me to read. Investors may think RPRX is a much better play at this point with Fis being much further out. Certainly the start of the PII will put Fis back on the radar.
Just my two cents.
So timothy, did you put your money behind the descending Parabolic-SAR indicator shift? Inquiring minds, you know. ; )
You present a simple but persuasive case.
Aroon looks ok. Aroon? Really? Timothy, please tell me you made that up. ; )
Carlo, this is not the company we invested in years ago. That said, I remain a long term investor. I am inclined to agree with much of the enthusiasm expressed here. As to the short term price moves, your guess is probably better than mine.
I am still around Carlo.
Witchcraft, timothy. Well-written witchcraft, but witchcraft nonetheless. But I liked your bottom line and I will have some resveratrol-flavored ethanol tonight to honor those thoughts.
From Hellsails reporting, we know that Vitaros was on the agenda of the advisory committee two days ago. We do not know the results, but if they recommended approval for some level of reimbursement there is still a regulatory chain of command to go through, probably on the order of a week or two if Hellsails is correct. So February is still a possibility for a France launch announcement, I hope.
Yes thanks for posting, hentied. Pascoe gives a very credible interview with a well honed message.
Hey LCK, yes she seems to be trading well. The Sandoz deal was an unexpected positive surprise this early in the calendar year. The news we have been waiting for are the launches for France and Spain. We may or may not get a price bump for that news but it should help establish/maintain a higher price base.
I separately posed the question to Eman as to whether these "warm" tropical countries would have to wait for RTD. Hope not.
I was wondering the same thing. HK still has a lot of autonomy and this product is not exactly political.
Thanks for spreading the Gospel, timothy.
I hope that means that you have redeemed yourself at the ask.
I am with Eman but I hope you are right on the money.
With the exception of Singapore and maybe Hong Kong, these are third world countries. However, the combined population is astronomical and there is enough money in enough hands for a good sized market.
Good Hellsails info, Eman. Thanks for posting here.
Hopefully the decision on reimbursement gives the green light to Majorelle.
The article cost up to $10K per the disclosure at the bottom of the article. I still think that was cheap PR.
I agree that was a great game.
Shazam,
I know** the company has been frustrated over the lack of positive response by the market to Vitaros for all the things discussed in the article. So it is pretty clear that they decided to hire a guy who could tell their side of the story without being subject to the safe harbor restrictions that makes them sound very cautious in conference calls and press releases. I think it is also likely they are trying to drum up some enthusiasm for the upcoming Vitaros launches in France and Spain. As you know, previous launches have been met with an underwhelming market response. Further and importantly, the near term news (in the next few months) will be all about Vitaros and not RayVa or Fispemifene. I think the article is a good move. Probably was pretty cheap.
That is my take.
**Per my discussions with IR.
Thanks RVL and SPOILER ALERT SOCIAL:
The article is 99% on Vitaros with no mention of Fispemifene and one little mention of RayVa. ; )
And yes, it was paid for by the company.
BB, I don't think that the company is positioning itself to be acquired. And I don't think retaining of the chair has anything to do with anything other than the rest of the board, particularly past chair Rusty Ray who lives on the east coast (and you know how those people are) recognized that the company needed somebody close by and with the current chair's expertise. The only reason Xanthopoulos did not get enough votes is that he sold shares. But I don't want to relitigate that vote.
Having said that, I agree with you to the extent that I think I could make a more compelling argument for a buyout than not, particularly with the recent options which I think would be accelerated in a buyout. And any buyout would have to make it worth the management's while, which means that we are talking way north of the current share price. Otherwise, the poison pill could be reinstituted by the board in an east coast heartbeat while shoveling snow.
Thanks Carlo.
Short interest (SI) declined by 135,684 shares (2,260,599) for the two week period ending 1/15/15.
Short interest really has not moved much in the last four months with a range of 2.208M - 2.245M shares. I would have thought there would have been a lot more covering during this period. However, there has been a steady decline from a SI of just over 3M shares a year ago.
Look Social...I am fine with that but recall that you butted into a discussion I was having with Carlo on launches because apparently you couldn't stand a thread focusing only on Vitaros.
We generally agree on the prospects for the company.
No, I did not say I wanted to hear the whys of your transition, I stated it correctly as a fact. I was not being critical. But you are all too eager to promote your thesis (again and again).
My argument, which you chose to ignore, is that you can't in the same breath say that Vitaros is a drag on the price when Irina downgraded the stock over the Fispemifene acquisition. Well you can and you did but you conveniently ignored facts. I don't agree with her but what she did is a fact.
The market is ignoring all prospects of the company equally.
Fispemifene is a high risk/high reward bet, but I don't view it as the slam dunk that I think RayVa is.
We all know the Femprox story. Your repeated soapbox China discussion is of your own (non-scientific) making and it is not as compelling as the simple fact that the FDA has issues with the concept of female sexual dysfunction and that is what big pharma is responding to.
The "for now" of Rivkind can be applied to Vitaros as well. For now Vitaros is not much of a revenue generator. For now, Fispemifene hasn't entered the PIIB trial. For now, Repros has yet to file an NDA. For now, RayVa still has three trial results to go. For now, the stock price is a buck and two bits.
I think Vitaros will turn out to be a very helpful revenue generator. I think RayVa is a slam dunk and will be an winner, but not a blockbuster. It does not have to be a blockbuster. I think Fispemifene is a huge bet with many years to go before commercialization. However, Pascoe smartly hedged his bet with the leg work already done by Repros and the FDA's consideration of Androxal early in the process. Fis won't likely drive the price until the FDA approves Androxal...and that won't happen until a year after the NDA is filed.
I agree with most of the points that you posted. Obviously the market is not valuing much of anything in the company including Vitaros as well as prospects for RayVa and Fispemifene. I do expect (and you hope) Vitaros will be more of a revenue generator than you do, but that will take launches in at least France and Spain and several more quarters. It may, in fact, take commercialization of the room temp device and we all know that won't happen until late 2016.
As a side note, when you invested in Apricus, your thesis in a word was "Femprox." Now your thesis is "Fispemifene." One could argue that it is Fispemifene that is a drag on the stock price. After all, it was none other than Irina Rivkind who expressed concerns over the Fis acquisition in terms of future dilution and downgraded her price target on the stock.
How many times do you need to make the point that you feel RayVa and Fispemifene are more important than Vitaros?
As far as meaningful revenue from Vitaros is concerned, did I or anybody else state that meaningful revenue (whatever that is) will occur this quarter, or the next or the next? It seems to upset you when Vitaros is discussed. Would it make you happier if there was no discussion of Vitaros? If so, prepare to be unhappy.
Thank you so much for the alert that RayVa and Fis are important.
Carlo, regardless of whether they move the stock price, launches in France and Spain are overdue and would be welcome in February. Italy, as you have noted several times, seems to be dragging behind. Is there an internal problem with Bracco? Are they operating normally otherwise?
SGM Holdings is Aspire. So the numbers you see reflect the ownership of Forendo and Aspire which puts "institutional" ownership (including mutual funds) over 20%.
However, I liked your Jimmy the Greek anecdote.
Kleanthis was clearly voted out by a minority of shareholders and as such was forced to resign.
The company chose to not accept that resignation slapping a minority of the shareholders in the face. (If I may paraphrase you, BWAHAHAHAHA.)
Kleanthis has been a net seller of our stock while our new board members, management, and new employees have been putting their own money in via open market buys. However, Keanthis still owns more shares than any of the current management (Ed Cox owned more). And as your buddy Bicster points out, all those sells were good trades.
Kleanthis is an IMO an impediment to our success not an asset. And I will add that as the next opportunity to vote him out nears I for one will be very vocal in the need for the completion of the great change we have seen by removing this last problem.
Well, you have in NO way made the argument that Kleanthis is an impediment, only that he lost the vote because he sold some shares through an automatic program. Do you really think that Pascoe would have been allowed to do what he has done (staff and acquisition) without Kleanthis' personal stamp of approval? Kleanthis is not only the CEO of a biotech that is doing rather well these days but his scientific achievements and reputation arguably are much greater than the cumulative achievements of Apricus staff and management, past and present.
RPRX has a market cap of $210M.
RGLS has a market cap of $860M. That's what I am talking about. Oh, Kleanthis is the CEO of RGLS. You can look up the ownership. ; )
Thanks Carlo!