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It certainly sounds a lot more credible coming from the new president. Hopefully the market will concur.
FDA accepts data for NDA
http://www.asx.com.au/asxpdf/20160718/pdf/438mh3k4jtkltr.pdf
Thanks. Good to know I'm not the only one making mistakes. Have a great weekend.
You can read all about it here:
https://listingcenter.nasdaq.com/assets/initialguide.pdf
I believe, Clinuvel would qualify under the Nasdaq Capital Market's rules today. But I highly doubt that management wants to take the company to Nasdaq at this time.
It takes a solid company to do good on Nasdaq. Otherwise you will be subject to manipulation and heavy shorting. Clinuvel is rather safe today at the ASX. Especially if you believe we are headed towards a major crash, which I personally do.
I don't think you should expect uplisting the next 1-2 years.
Many on this board bought in at very low prices years ago, and I congratulate you for that. It makes it significantly easier to stomach going to $4 and back to now $1.22.
I have invested in many biotechs and with a great deal of success. But never have I misjudged the direction of a company so severely as with CTIX. I am severely in red on CTIX and although I do think Dr. B. can help clean up I think it will take a considerable time to recoup my paper losses. I think there are two kinds of investors present on this board: The early birds who can be more laid back about the cataclysmic decline from the highs and people like me who have been here for some years and have been adding.
A couple of years ago, this board was a beach party. I have never been part of the hype and have never liked the CEOs PR style. He has done many things right, but the low pps shows that he has reached his limit. The science is very strong but it needs a steady hand. I applaud the CEO for realizing that he needed to take back seat now.
Today, this is my worst investment ever and I kick myself for not putting my money into some of the very successful companies that I am in.
But, hopefully, things will look better in a year or two. Still holding for the science. I never was much of an investment genius.
Please no more PRs until there is something substantial to say. A move from Pink back to QB isn't exactly something to be proud of.
Apparently, Dr. B. is less trigger happy than the CEO - which I applaud.
Do you have Level II ?
G-BA benefit assessment of Scenesse.
In German.
https://www.g-ba.de/downloads/91-1031-217/2016-06-20_Wortprotokoll_end_Afamelanotid.pdf
Yeah. Sorry. Drinking whiskey in Montana's mountains make June and July look like Jack and Daniels.
Ha ha. On vacation. Sorry. My sense of time is on hold.
Do we know if the July 15th conference took place ?
Yes. Usually it shows immediately. GL
I agree. But the FDA wouldn't bother approving the application for FastTrack if it knew already that it would never approve Scenesse. So we have now moved from a scenario some years ago where the FDA told Clinuvel to go back to Australia and never come back, to a situation where it clearly is a matter of when - not if.
It seems to me that the CEO could be retracting to a role as CFO but will in fact still be CEO while Dr. B. will be taking on the duties previously carried out by Mr. Erlich. I think we will see Mr. Erlich as chairman of the board and Dr. B. as CEO sometime in the future.
So Dr. B is now de facto CEO and our new face ?
Wonderful news. Congrats all.
There is close to 0 chance that the FDA won't approve Scenesse once we reach PDUFA.
If they submit the NDA after the patient meeting - perhaps sometime EOY or in January / February, then we will see a PDUFA date sometime next summer. Perhaps June / July, 2017.
Just in time for EPP patients to at least enjoy a part of the summer without pain.
This news ought to add at least 50 % to the share price once the ASX opens this evening. I bet it won't, though, but eventually this is extremely valuable.
First and foremost, this is a day of celebration for those who suffer from EPP. I am extremely happy on their behalf.
It's in Holland patients are being treated. Germany and Austria will follow any day. And then at least 6 other countries this year according to a press release. It's a slow moving train, but it's carrying a very valuable cargo.
Comprehensive and level-headed attempt to put a future value on Clinuvel. By Frogster of SS.
***
Hi Farma. Sorry for slow reply - you posted just as I went to bed.
Your question is a very fair one, but also a very difficult one to answer with any confidence or accuracy. As Joe Schmoe accurately said, given the transition of the company from research to commercial entity, visibility of the financial shape of the business model IS very low.
As they say, ALL models are wrong, but some are useful. I don't know that what I'm about to say is useful, but we'll see.
Your model came at things from a bottom up approach - what is the EPS value of each patient? I prefer to come from the other side, from a top down approach. The reason (for me) is because the first few patients cover fixed costs and deliver nothing in terms of positive EPS (yes, they reduce negative EPS, but hopefully you get my point that the EPS growth contribution between patients 0-100 is different to 600-700). Anyway, two different ways of coming at the same thing. Either is valid within their constraining assumptions.
So, what can we say? Not much with certainty, but the following feel like fair assumptions to me: (all A$)
Fixed costs historically (ex any R&D costs) approx 5.5m (2015 saw 5m more than this thanks to generous board and management share issuance scheme - I'm assuming this is non recurring). After roll out, I'm not sure there are many reasons to assume fixed costs will go up all that much, but to be safe lets assume they rise to 7m.
Variable costs historically are really hard to pin down, but manufacturing COGS are probably not that high. Maybe 10%? The really big unknown is what cost impact will the high regulatory burden bring? I'm going to guess another 10% (this may be wildly wrong!). This means 80% of revenue might be available to cover fixed costs and then flow to profit.
Another really big unknown will be the R&D costs going forward. I guess these sit between fixed and variable costs in that they are kinda discretionary, but kinda not. These (combined) for the last few years have been approximately 2.5m. The reality is these will most likely rise as Enfance is pursued and Vitiligo etc. etc., but lets assume these stay flat, but acknowledge they probably won't.
Financing costs will remain essentially zero, and I'm going to assume a (possibly high) tax rate of 30%.
If the average implant cost is 25,000, and on average 3 are used per patient then for 1000 patients you get annual revenue of:
25000*3*1000=75,000,000
After variable costs: 75,000,000*0.8= 60,000,000
After fixed and research costs (i.e. EBIT): 60,000,000 - 7,000,000 - 2,500,000 = 50,500,000
After tax at 30%: 50,500,000 * 0.7 = 35,350,000
leading to an EPS (assuming 47m shares): 35,350,000/47,000,000 = A$ 0.75
I could easily imagine the stock carrying a 20x P/E implying A$15 per share - which is smack bang in the middle of your 10-20 range for 1000 patients (and I promise you I have not engineered the numbers to work in that way!).
So, for EPP alone and with, on balance, assumptions erring on the conservative side we get to the same point. Add another 1000 patients and the numbers come to and implied A$33 share price. Throw in line extensions and other indications, and the numbers could grow much higher, but this is enough speculation for me in one day!
As before, HUGE assumptions included in the above. Yes, the assumptions will be proven to be wrong. Hopefully they will be proven to be useful.
He is now the the person at CTIX with the highest level of education and especially the broadest background. He might now beat Dr. M on the scientific side but he sure does beat Leo on the business side. His combined background could be very valuable for CTIX and on paper he would make a better CEO. Perhaps not IRL here and now. But he has very good credentials and with Leo as chairman of the board and Dr. B as CEO is think the company would be better positioned for the future.
As long as one of the observations are correct, I'm happy
Same to you
From SS.
The PR guy has been appointed general manager of the British office.
Good news. It must mean that operations there are ready to fire on all cylinders and that they are ready to recruit a professional PR person or maybe outsource this important task to a really good company.
QUOTE:
Dear EPP families, friends and carers,
In May Clinuvel released a beta version of a new website, www.EPP.care. This is a new project from Clinuvel aiming to improve the quality of information available on EPP online. Many of the associations and physicians who represent the EPP community then reviewed the site and provided constructive feedback for how we could improve content.
Today we have launched the first version of the site post-testing which can be accessed at www.EPP.care. It is our intention to build upon this project, including adding more interactive and video content exploring and explaining EPP. Over the coming months we will work to increase and improve the content online as well as working to connect patients to expert physicians. I welcome your feedback on this project and how we can work to make it more relevant and useful to you.
Thank you for your ongoing support.
Kind regards,
Lachlan
Lachlan Hay
General Manager
Clinuvel (UK) Ltd
Tel: +44 1372 860 765
Twitter @ClinuvelNews | Facebook The Photoprotection Network | Online clinuvel.com
http://www.epp.care/
I had promised myself that I'd stop buying but I can't help it either.
A couple of observations - and I admit that they are influenced by wishful thinking:
Leo would not hire such an expensive person without being pretty sure that money will flow in soon.
Dr. Bertolino would not accept a position in CTIX without being pretty sure that there is a good chance of success. After his abrupt departure from Revance just before they crashed, he does not need to be associated with another sinking ship.
I don't see Leo as incompetent at all. Quite the opposite. But we all have fields of expertise and we all have shortcomings. Ones biggest strength is to admit the latter and build on the first. IMO very few entrepreneurs make good CEOs when the company matures and few big company CEOs would have been able to do what Leo has done quite successfully.
I recommend reading this article:
http://www.pharmexec.com/blueprint-great-leader
Some of you have met the CEO: Would he ever consider resigning as CEO and taking on the position as chairman of the board ? I tend to agree with many of the points in the new SA article. Leo has been - and is - a highly energetic entrepreneur. But he's not a highly educated, proven pharma leader with a well respected name and a solid track record.
SEC filing about him quitting Revance:
https://www.sec.gov/Archives/edgar/data/1479290/000119312515361237/d44564d8k.htm
Certainly, Dr. Bertolino seems to be a great hire. Seasoned and highly competent. I have not had time to research his involvement at Revance, but apparently that company failed miserably. I reckon that is why he is moving on.
http://investors.revance.com/releasedetail.cfm?releaseid=865850
Clinuvel is well known by institutional investors here in the US. Retail will follow when or if they make it to Nasdaq. Until then, the few lucky retailers here will benefit from an early entry. The only thing that will make this stock move now is revenues. And they are about to explode. Also, there are many ways to invest. Not all investors have the time, energy, interest (or anxiety) to follow a stock on a daily basis. Only a small fraction of investors follow, read or post on a message board. But at the end of the day you will make the exact same profit as the guy who follows the stock closely. It's only a matter of entry and exit. I have no doubt that an entry now and an exit in a few years will be very profitable.
Scenesse launched in Europe.
Finally. Congrats all. Especially to all the patients.
http://www.asx.com.au/asxpdf/20160622/pdf/4381m69nvkc0lc.pdf
Good news in Netherlands. Roll out imminent.
https://www.facebook.com/groups/AmericanPorphyriaFoundation/permalink/1425998677426303/
Meanwhile, Swiss insurers are beginning to soften on the reimbursement issue and will now pay for 3 implants in some cases.
Germany seems to be delayed but still on track for full roll out and full reimbursement.
HST NICE is due to come with a decision within 1-2 months IMO and Norway is also discussing reimbursement.
These are the knowns. Many more EU countries to follow soon I think. Roll out and reimbursement is slowly progressing.
The fact that he is so direct about it must mean that he is beyond confident. After a lawsuit you should think that the CEO would only convey very accurate information about the properties of the compounds. I would have expected him to say that B has shown encouraging signs of anti-inflammatory activity. He takes it up a notch.
This is how a PR should be written. Good work.
Just saw the dismissal. Congrats all. How wonderful it is when justice is done. Here's hoping that the CEO will now do absolutely everything to behave in a manner that in no way can facilitate or promote doubt about himself, the company and the pipeline. To the point and timely PRs written in a mature language will go a long way. And let's sue the pants off of Rosen and Kim.
I think the CEO is confusing PR with CPR. And done the wrong way both have fatal consequences.
Timely, to the point PRs and the CEO refraining from calling out the president would have avoided the negative attention this company is suffering from.
I can recommend studying the FDA process if you are not familiar with it.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/default.htm
Again, an approval in Europe does not equal approval in the US and vice versa.
Clinuvel will have to submit a dossier with the FDA and the absolute minimum review time frame will be 6 months before PDUFA.
We as investors are not privy to information about why Clinuvel has not yet submitted an NDA and what the FDA is waiting for. Could the FDA work any faster ? Sure. But there are 1000s of drugs waiting for evaluation, and to give them a little credit, their primary mission is to ensure that the American population gets safe drugs.
Don't let impatience cloud a fair assessment.
Penguin, you know that I am aware of SS. I ascribe your aggressive attitude and you misunderstanding my post to the language barrier. But please try to keep it civil.
1) My comments were to clarify which arguments Clinuvel could use to make it clear to reimbursers why $7000 is not a baseline price and why the new price is totally fair.
2) The price has not been established.
Clinuvel is asking a new price which is subject to negotiations. It might stay at the current asking level but I anticipate it to go down by 5 % - 15 % which is standard. It's still a very good price, though.
3) Again, the point that you missed, is that there is no connection between the old compassionate use price and the new price Clinuvel will end up with in Europe and, hence, the insurance companies cannot claim that Clinuvel is hiking the price. They are establishing the price, and there is a big difference.
Swiss article:
http://www.20min.ch/schweiz/news/story/10778994
At least Clinuvel gets a chance to reply in this article. However, the smart quote from Lachlan would have been:
"Our company has extraordinarily provided the drug in Switzerland without a profit for almost 5 years while seeking
formal approval with the EMA. Naturally, with regulatory approval that has to stop in order for us to stay in business."
I think it is very important to get the message out:
This is NOT yet another greedy pharma hiking
their prices 5000 % Shkreli style.
This is a company with a recently approved, yet to be marketed,
not yet priced in any country, very expensive to develop drug which is heavily regulated and hence
expensive to maintain and extend distribution for.