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Post from Seeva222 on Sharescene. An excellent roundup of available info and current status.
What we know
> We have EMA approval
> Universal pricing is almost a reality (FU Germany) - there are many more countries in the queue
> The holdup is capacity, not demand
> GB will be coming online
> We're above the most optimistic AGM forecasts on revenue and the bottom line
> We're fast tracked with the FDA and they've accepted that the risk is acceptable. Efficacy seems to be the only issue and the bar has been lowered on efficacy for the FDA.
> A SE Asia platform has been launched - with a potential massive market. Clinuvel with have a proprietary compound (right language?)
> It looks like there's a clear move to the NASDAQ in the offing and a repositioning toward NA (which will open the doors to JVs and acquisition)
> Revenue numbers and annual report will come out this month
Indications
Solar Urticaria, EPP, Vitiligo, HHD, Actinic Keratosis
Psoriasis http://www.google.sr/patents/WO2015067503A1?cl=en
Acne http://onlinelibrary.wiley.com/doi/10.1111...4658.x/abstract
EPP Market
Cost (in AUD) $22,500
Q3 Implants (est) 1.7
Current | Potential
Quarter Revenue $11,054,250 | $84,705,900
Ann Implants (est) 3.0
Current | Potential
Ann Revenue $19,507,500 | $149,481,000
Current | Potential
USA - | 1,000
Germany 55 | 400
England - | 400
France - | 350
Netherlands 104 | 250
Italy 50 | 50
Norway - | 41
Austria 40 | 40
Switzerland 40 | 40
Sweden - | 40
Belgium - | 40
Czech - | 40
Portugal - | 40
Hungary - | 40
Sweden - | 40
Scotland - | 25
Denmark - | 25
Finland - | 25
Slovakia - | 25
Ireland - | 20
Total 289 | 2,931
I forsee this discussion board becoming the preeminent site for Clinuvel in the United States. Not all members here will be able to access Sharescene or Google Groups for that matter, but considering we are on the cusp of FDA lodgement and possible NASDAQ listing this site is well positioned to take advantage of forthcoming interest. As I am a member of Sharescene and Google Groups I will post what information comes to light if someone else hasn't done so already. Cheers and good luck.
I don't think a takeover is imminent, certainly a partnership is possible in the near term. There could be another capital raise to fund the vitiligo trials, not sure how much money that would require and whether Clinuvel could fund it on a rolling basis as revenue streams in.
I don't think PW would sell out at anytime in the near future, he has been in this game for far too long to just give in on the cusp of greatness for Clinuvel. I think the recent share price hike from $5.20 to $6.40 or thereabouts proved that rises such as these can be sustained, I'm deeply hoping there won't be a severe pullback as profit taking occurs. My take: another surge will happen on Monday regardless of whether the report is released in the morning or afternoon, be it from new interest generated from the phenomenal hike or lack of available shares. The report will further this surge but their could be a pullback later in the week. However I think the stock will remain permanently above $10.
Incredible to think that we will be at $10 whereas I was certain this figure wasn't going to appear until the middle of next year. This stock is starting to take on a price boom characteristic that can occur with other pharmaceutical stocks, for example a nascent pharma with a Phase 2 cancer drug where stakeholders bet on future prospects well before time. However, the difference with Clinuvel is that it is a bona fide company with revenue and possible first profit coming soon. Given this solid foundation that Clinuvel has, stakeholders could accumulate and new investors could drive the price well ahead to a level that is not commensurate to Clinuvel's fundamentals.
I do hope this occurs quickly though, but at the same time it makes for a nervous experience. Will have to rely on Kenny Rogers' advice from 'The Gambler"...
I'm wary of the possible partnership arrangements that might come to fruition. Knowing PWs nature of complete control it sort of goes against the grain the idea of having a partner who benefits substantially from the arrangement. Obviously it would have to be a good deal to entice a partner but I don't like the idea of royalties. Rather I'd prefer to see a sharing of profits because they will be very substantial concerning vitiligo in the US. Clinuvel needs a partner with deep pockets and expertise to distribute and market so the partner is going to have to be a medium size entity at the least. Any ideas who this could be? I doubt very much it will something like Biolabs Singapore, no im talking a real bona fide pharmaceutical heavyweight. Another angle to this is the ramping up of multiple indications via this arrangement, maybe this is the end game for PW, to develop this drug for all purposes in the US as quickly as possible via the arrangement. The soccer team could be purchased in no time at all...
Today was a complete disaster, potentially quite a lot of money lost with professional traders but that's the game we play. I think this event is unprecedented, a cyber attack perhaps?
The ASX is rather coy (or embarrassed) about it although probably no point to go into technical details. Looking at the trades today for CUV it appears there is still accumulation happening, may be additional pent up demand tomorrow which could see another significant rise, but I think we might be at another resistance point again. That's totally fine, I think to rise to the current share price in short order is terrific and has probably alerted quite a few funds to Clinuvel's prospects. Momentum will be critical leading into the final weeks of October, another run up would be good post-quarterly report to take this over $10.
Farma the resistance levels at 4.20,4.80,5.00, and 5.20 had a fairly large volume change hands. I don't think that there is any doubt that whoever is in control of the market wanted to accumulate, a lot of crosstrades and buyer/seller middlemen moving large parcels from one to the other through prearrangement. I am very wary about the current situation too, considering exactly two years this month the share price plummeted (however that was Retrophin cutting loose), but then I figure maybe the whales are done and now the price is being allowed to rise according to the mood of the market on the day. As it is I'm sure the word is getting around, and I'm totally convinced sales are well underway in Germany. What strikes me about the last two days is the amount of shares bid for before the market opens. I don't believe I've seen the market open the way it has on these days and that's encouraging. I'm probably like you and want this to climb more surefooted but conversely, maybe it's about time this stock soars to a level that is commensurate with its immediate prospective value. Whatever the case $6.50 was probably a bit too conservative ??
Vitae Pharmaceuticals is an example of where Clinuvel is undisputedly headed. Yet with impending FDA approval in the US 2017-18, we are way in front of Vitae. Dr Wolgen will undoubtedly be thinking about additional indications such as psoriasis or dermatitis let alone HHD. What is the good doctor's strategy? Will he play safe and institute an exact copy of the administration of Scenesse to ease the FDA's concerns? I figure he must stick to the strategy to attain approval for vitiligo so as to secure the business model and the revenues that it generates. To hold out for the right to let Scenesse be available offlabel may jeopardise this strategy, however I would think that the high asking price would stymie attempts to offlabel unless Clinuvel enters into discussions with American payors/reimbursers to agree pricing for HHD. There is no doubt in my mind HHD could command a similar price as EPP, regardless I think Dr Wolgen will take the slowly more measured route to market. He's in no hurry, he wants to maximise the value of Clinuvel for future greatness be it by buyout or market domination...
Good analysis Farma, I'm rather curious now as to what's going to happen to share price at the end of October. I've noticed with the trading that it's hard to break away from $5. But there is some whittling away of shares at $5.05-5.10. Once those are gone it will be hard for the market makers to keep a lid on it, if they are determined might see some wild jumping around of the share price but hopefully stabilises into a steady upward trend December onwards.
I don't know how this price was arrived at considering Clinuvel refused to come to the table. Something doesn't sit quite right here. It appears there was a lot of bluffing on both sides and some eventual face saving, and eventually the price settled at 16k Euro. Second tier pricing perhaps? Can we expect the same from Switzerland or any future country for that matter? Is 16k Euro the lowest limbo the price would go? We need favourable outcomes in Scandinavia and the other western Euro countries, and to not be held to ransom otherwise the "compassionate pricing" might start a trend thats not to my liking...
There is some depth at $5.09 that's being soaked up. Hopefully this clears the floor to go well beyond $5.50 by the release of the next quarterly. Come next quarterly I think she'll top over $6 if not before. Conservative?
Great news no? Wonder if we will see a spike in the share price today as this preliminary price is higher than the 22-25k that's been doing the rounds of late. Exciting times ahead. Next quarterly report not too far away as well....
FDA Fast Track Designation awarded
http://www.asx.com.au/asxpdf/20160706/pdf/438d04cjr2bg20.pdf
Very good news guys!!
I found the trading over the last two days somewhat peculiar, as if the big wigs or bots or day traders are holding back, waiting for the next imminent news to be released regarding July sales in Germany and I think is it Austria?
The demand has dried up but no peddling of low cost shares is occurring much either. It would only take a short burst of furious trading to get this stock flying above $5-6. It really is locked, cocked and ready to explode...
Ridiculous. Her insurance company is not the same as a national reimbursement scheme. And this video is old news. I will grant you that Clinuvel may have a harder time convincing some of the euro countries, and we shouldn't forget the two tier system that was once mentioned before. In hindsight this doesn't seem very egalitarian hence why PW is committed to one price for all. I will take the recent accumulation by Lagoda as a positive sign and that they know a lot more than we. Hopefully they don't take over and deprive us of future riches...
Possibility of profiteering coming soon. ADR has dropped may see a slight correction , or we may see a surprise ploughing and the stock on the ASX rises today. Either ways I think we are on track for a new share price high in the coming weeks.
State of the shares: what gives?
I've noticed that there is a large sell order (made up of four individual orders) for 75k odd shares @4.20. The buy side, which has been stacked for the last few months is now less than the sell side. I'm not sure what this means, but whoever was keeping a lid on the market is content to let it rise today I feel. I wouldn't be suprised if that 75k order is bought first thing this morning. With impending distribution in the next few weeks, it's quite possible that the lid might be lifted and left to true market forces from here on in.
I think Controvers has made a very good call over at Share Scene regarding pricing. I think he is right in saying that the price being kept under wraps so as not to invoke public furore over high pricing. However I don't think there is a disadvantage if other countries find out about the pricing before reimbursement negotiations begin. They will know eventually. The question is when will the public at large know what the pricing will be?
Hi Farma,
I have been struggling to determine what the share price will be or should be at in the coming months. It is my firm belief that Clinuvel are drip feeding the remainder of the outstanding 700k odd shares from the CR not accounted for. Thursday's action last week saw an opening drop to 3.75 for 20k shares, and then multiple lots of 523? shares at 4.00-4.15 as if they were trying to flood the system and hold down the price. This also gives the appearance of sustaining an orderly market so as not to get speeding tickets. One surely would have been issued by the ASX if a second day of rampant rise had been documented.
IMO I think the share price should settle at $10. I still think the retail interest is not quite their yet however i don't think the instos can account for all the shares traded and so this could represent an increase in interest from retail or the regulars are adding to their portfolios. Once the announcements are made regarding price and first sales, the sp is going to go crazy for a bit. The price alone if confirmed that it will be in the vicinity of $15-25k per implant will drive the sp to your estimate in itself..
The question is: why is retail waiting? Are they waiting for a full de risk before jumping in? Whatever the case retail will know soon enough when publicity gets out about the sp climbing. Add to that due diligence on the part of newcomers and we could see a self sustain chain reaction soon enough.
Currently I would expect the sp to reach $10 in the next 3-4 months. $10 provides an affirmation of the reasons why I am in this stock, and assures me that it is on the fiscal path that we anticipate with a rise to $20 in the next 24 months.
How are you Farma;) keep up the good work here, good to see this board is keeping it clean. What to expect in the coming months? The sp should stabilise above $3, folks will still be wary I think even when sales are registered. APF being very proactive, will be interesting to see how the FDA react. Our prediction was correct: Clinuvel are indeed using Singapore to focus on Asia though admittedly I was suprised about including India. No matter, more opportunity to come. Do you know if Uhoh is running another group? If he wouldn't mind I'd like to join, send me a private message if you deem this appropriate. Have a good day
Do you think PW might have done this through a third party in lieu of doing a round of fundraising, or just to have another fund onboard?
Hi Farma thanks for the introduction, looking forward to sharing news here with you.