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.
I’m considering buying the whole company just to be able to fire the CEO.
December to remember, Mr. President, we’re ready, B for Rio Olympics, 2017 will be the year for partnering, missed September milestones and the list goes on and on.
Great compounds.
Desperate and very immature CEO.
Interesting. Looking forward to his reply.
I don’t believe anything from management anymore. The bogus September milestones is just the latest example of the continuous stream of lies and deception.
Choosing VP as the new orphan indication is a brilliant move. I was expecting XP, but this makes much more sense from a business perspective.
First, they will use the established framework of the EPP centers in Europe to conduct the trial(s). Likely, they will do the same in the US for the pivotal
phase 2/3 or 3 that will follow the initial 2a. This is less costly and scientifically easier than stating all over in XP where they have
no network yet. If they follow the same strategy, they will probably initiate XP trials in Japan once Scenesse
is approved for EPP there in a year to two.
Also prevalence is much higher for VP than in XP. VP = 1:100.000 (much higher in South Africa) and XP 1:1.000.000.
That gives us at least app. 6000 patients in Europe and 3000 in the US. 15.000 in South Africa.
They will dose VP patients every 28 days mirroring the dosing cycle in treating Vitiligo. It seems they plan to use
the data collected during the upcoming VP trials to also support the future NDA for Vitiligo. Smart move using synergies.
Even if they cut the price per implant down to $6000 that’s a very significant business case. We don’t know how many implants
they plan to administer yearly to VP patients but let’s assume 6 to be conservative.
Uptake will probably be fairly high since there is no alternative, so let’s assume we can treat 4000 patients in Europe and 2000 in the US
which is probably still conservative.
6000 patients paying 6000 USD 6 times a year = 216 m. USD. In my book that represents <60 USD pps. Add South Africa and that number
explodes but I will leave that out for now. Also, they may not lower the price per implant at all and then my numbers double (!).
Add EPP at the new lower price per implant administered 6 times a year (which is probably coming up) to 3000 patients coming up
and that’s 108 m. USD = < 30 USD. Add Australia and Japan and the number is even higher.
VP and EPP combined represents a future share price of 100 USD at the very least. 150 - 200 USD if they don’t lower the implant price.
The FDA and EMA are very likely to approve an sNDA and I expect the best possible scenario is a PDUFA for VP sometime in 2021 but
already now it should represent a risk weighted value of somewhere between 10-30 %. If they show good results in the phase 2a
which I expect they will the value will be higher also given the fact that the likelyhood of regulatory approval is extremely high for
a second indication.
At the current price per implant stand by my previous calculations and think that EPP is worth at least
50 USD in Europe and the US combined short to medium term. That number will go down if they lower the price per implant, of course.
I’d say that neither Vitiligo nor any of the other opportunities are reflected in today’s pps. Enfance, topicals etc. Right now, the pps
merely reflects the opportunity for EPP in Europe and we’re still on the very low side. VP ought to add a few Bucks today and 5-10 USD when the market realizes that it’s
a less risky endeavor than gaining regulatory approval for a new drug.
There’s still a lot of work to be done and it will be interesting to follow the work with VP and hopefully soon also Vitiligo.
My 12-18 months target is 50 USD. By then, we are either approved in the US or very close to be approved. VP trials
have hopefully been successful in Europe, the cosmetic line is underway, Vitiligo is revived, regulatory approval in Australia and
Japan is underway and Enfance for treating the pediatric population is hopefully also moving along.
I look forward to the day you’ll benefit from Scenesse and be able to enjoy the sun.
Fair value for EPP Europe is $20-25. <$50 when the US is added.
XP is at least as valuable as EPP and when added as the next indication it will have to be reflected in the share price.
Vitiligo is a potential blockbuster and even with a low, risk weighted value is should represent $10 when it’s taken to phase 3.
The new cosmetic line will also represent a value and then there is Enfance and the new products that albeit at an early stage still represent a value. Especially because it’s increasingly clear that management actually delivers.
$100 is not unrealistic within 2-5 years.
Welcome to a great Monday. If you’re new here, you’re lucky. If you’re an old timer, even luckier.
Good night, and good luck.
One if the best write ups about Clinuvel and the potential.
https://ethicalequities.com.au/2018/09/12/introducing-clinuvel-pharmaceuticals-limited-asx-cuv/#respond
After tomorrow, the only thing I expect my (luckily reduced) pile of shares to be good for is a tax offset.
One non binding term sheet after how many confidentiality agreements ? 20 ? That’s underwhelming.
And I now realize that the milestones were BS all along. If the CEO is able to predict at this time that the FDA won’t grant BTD, surely he would have known when the PR was sent out. Still 19 days to go. How come he’s able to call it off already ? Because they either never filed or filed so late that the Sep. 30. deadline was never realistic in the first place.
Sadly, the CEO has driven this company into the ground with a steady hand. I have been optimistic along the way because of the science but sceptic because of the amateurish pumping by the CEO. I gave him the benefit of the doubt but should have listened more to my gut feeling. Luckily, I did and sold a good part of my shares. But not all. And emotionally, it feels very empty that the compounds that could have helped so many in need most likely will never make it to an NDA.
“Obama, we’re ready.”Do you remember that one ? That PR alone should have made me run for my life. But again, I deviated from my own rules of never investing in a company with a CEO that I don’t trust. I was blinded by the science.
I was hoping that the great compounds would make it to market DESPITE a flawed management team.
I’ve not lost a fortune. But I’ve invested to much time and emotions in this company hoping it would be able to help a lot of people.
I will never make this mistake again.
With the clock showing 11.59 PM all I’m saying is that every second counts and that we need to know if we’re dead or alive pretty soon. I expect the CEO to work round the clock no matter what’s on HBO.
I work Christmas Eve, Christmas morning, on my wedding day, my sons birthday, heck I would postpone my wedding and my mother’s 90 year birthday if the future of my company and it’s shareholders depends on it.
Yes, very nice. Seems like folks are beginning to notice us.
The latest update from Sphene Capital with upgraded price target:
http://www.equitystory.com/Download/Research/Clinuvel_UpdateReport20180907_english.pdf
Hi Karin, I’m curious as to what you’d think a fair buyout price would be ? Normally, you’d not see a premium exceed 100 % maximum, and at the current levels that would still leave many long time holders severely in red. I’m hoping for a partnership.
New investors:
Welcome to the CLVLY board. You’ve probably heard about the company or the product and found your way to this board to get more information.
The best way to start is by reading this independent analyst report by Sphene Capital:
http://www.more-ir.de/d/16065.pdf
CLVLY and CLVLF are ADRs of the Australian listed stock, CUV. The stock is also traded on the German stock exchange; in Frankfurt under UR9.
The company already has a Nasdaq International Designation but plans to list “on a foreign exchange” before July, 2019 according to the latest PR. The best would be a Nasdaq listing and a relocation of the company’s headquarter to the US. Currently, it’s located in Melbourne, Australia with its main operations in Switzerland and London, GB.
The stock is extremely tightly held by institutional investors and long time believers who have been here for more than 10 years.
Happy reading and don’t hesitate to ask questions.
I’m pretty sure that other one will make a come back. In the mean time I’m very happy about the steady progress CLVLY is making.
There are so many catalysts coming up and FDA approval could easily double the sp.
Validation of the NDA next week and possible priority review.
Inclusion in the ASX300 index coming up.
Launch of cosmetic line probably before EOY.
NDA approval sometime in 2019.
Nasdaq listing before Q3 2019
Start Vitiligo ph3 2019
And much more.
Fingers crossed for more steady progress.
What a nice Friday this will be. Enjoy the weekend, all.
We all get a dividend. Also the ADRs.
And now a dividend paying stock.
FDA validation of the NDA within a week.
Hopefully priority review but we will live without.
I’ve never been happier about this investment.
GLTA
I think you misunderstood me. My point was that I wouldn’t touch PTN and that CLVLY is the one with the momentum. In no way a death trap.
They have the most solid management you can get, no debt, lots of money rolling in and soon FDA approval too. They have Nasdaq international designation with the main stock trading on the ASX and depository receipts trading OTC here in the US. My point was that if you’re interested in malanocortins CLVLY is the only company worth buying. I wish PTN had better and more honest management because the MC4R potential is also very interesting.
If you guys are interested in melanocortins there really only is one company to invest in. Great product. Solid management. Great momentum. Approved in the EU and NDA submitted with the FDA.
I’ve been looking at Palatin for many years but decided not to touch it.
CLVLY, however, is as solid as it gets.
Approaching fair price based on current sales in Europe. FDA approval will more than double the current potential and, hence, a doubling of the sp is warranted. FDA approval = $15-20. Fully rolled out in the EU and the USA $40+.
Then comes cosmetics, new indications and acquisitions of new products / companies.
Non-executive director acquires 1,3 mio. shares at a price of AUD $10 through a deal with institutional investor Lagoda. Very bullish.
I think it’s more and more likely that Willem Blijdorp and his company B&S International will be
instrumental in distributing Clinuvel’s new cosmetic line and that it will
probably be through tax free retailers in airports; mainly or partly in the Asia Pacific.
Cosmetic giants like Estée Lauder, L’Oréal, Unilever & Procter and Gamble are all very focused
on travel retail, according to this article: http://sc.mp/fJ7SDs
The market is huge and travel retail is exactly what B&S International are experts in.
The article mentions the TFWA international summit in Cannes and how the Tax Free Works Association gathers the
Global travel retail industry in France for this 5 days summit. I’d never heard about TFWA but
apparently Clinuvel attended the 2018 TFWA Asia Pacific conference in Singapore in May: http://clinuvel.com/2007-announcements/ite...gory/776-events
Scenesse isn’t exactly a product for the travel retail market so when Clinuvel attends this
conference it has to be with a different product and scope in mind. Chivere and t’Sumoyle seem
like products that could be a shoe in for this market.
About the billionaire Mr. Blijdorp:
"Mr Blijdorp is the founding member, majority shareholder and a current supervisory Director of B&S International NV, a privately owned Dutch group focused on the wholesale and international trading of luxury and fast moving consumer goods and pharmaceutical products. He managed B&S International for 27 years as CEO and remains actively involved in the company’s expansion strategy, helping it to become one of the largest trading houses globally with a compounded annual growth rate of 10% for the past decade. Being recognised for his expertise in merger and acquisitions and leadership, in 2014 Mr Blijdorp was awarded the Ernst & Young Entrepreneur of the Year in the Netherlands."
Well stated. I agree with most of what you write.
And all that jazz
Which is why I’m still around. I just wanted to note that not everybody who criticizes the company is employed by dark forces. I’ve always been skeptical towards the CEO’s style but have been fascinated by the products. My risk reward calculus turned out in favor of staying because I think he might be able to pull it off. I don’t want the pps to go down. I want it to freaking explode. But criticizing the CEO on the way is my right.
80 % is close to wiped out. And btw, I don’t sing.
How about all the folks who just invested a fair amount of money in this company only to see it wiped out ? The world is not only populated with pumpers and bashers.
This is most horrible and painful investment I have ever made. The products are great, the commercial potential is obvious but management is absolutely incompetent. That’s my concluding after having suffered a paper loss of + 80 %. I still hope the qualities of the products outweigh the incompetence of the CEO and will eventually give me my money back. But whoever claims this is a good investment by now is delusional. Luckily I only hold a minor porting.
Very odd that they chose to do trading halt just because of the NDA submission. But very positive that the ball is now rolling in the US. I hope for a March PDUFA. $20 by Q1 19.
It’s very strange. Perhaps it’s considered material that they meet a deadline for the first time ever.
Does anyone have Level 2 on this one ? Interesting day. Halted in Aus and Germany but not here in the US. Strange move by management.
Per diligentiam sinceritatemque progredimur et populum servimus,’
Luckily, they translated it to English most places:
‘Through diligence and integrity we advance and serve the people.’
Yes, the stock has done good and pretty much as I was hoping for. If they file the last module of the NDA within a few months we should see the next leg up.
Approval is more than likely in the USA and that more than doubles the potential.
Add the cosmetic line that we still know nothing about and the renewed focus on Vitiligo and there is a huge potential. I expect $20 USD within the next 12-18 months.
The new logo is absolutely horrible. And the website is overloaded and difficult to navigate. Not to mention the Latin crap.
But the product is still the same and it’s a winner.
It seems, Vitiligo is still in their radar. They post a lot about it on FB and Instagram.
Down the road we might see Scenesse being trial for a range of CNS disorders. In a recent patent filing they mention Multiple Sclerosis, Alzheimer's Disease and other dementias, Parkinson's Disease, Amyotrophic Lateral Sclerosis (ALS) and which is also called Lou Gehrig's Disease, Huntington's Disease, Degenerative Nerve Diseases, Encephalitis, Epilepsy, Genetic Brain Disorders, Head and Brain Malformations, Hydrocephalus, Stroke, and Prion Diseases.
Here and now focus is on the NDA for EPP and then probably Vitiligo.
EPP alone warrants a much higher pps.
Nothing has changed in the fundamentals. This is purely technical IMO. The initial fall began on the ASX on relatively small volume. Probably a retail investor panic selling for unknown reasons. Then the avalanche spread to Germany where a lot of new investors have bought in recently. Some of them likely saw the fall in Australia and panicked too.
Fundamentally, things have never looked better. Of course, bad news can have leaked and caused the sell off, but I doubt it. This action is typical before big announcements so I’m actually quite optimistic.
Furthermore, if you look at it from a TA perspective there was a gap that needed to be filled before we can go above $14 AUD on the next leg up.
GL
Just touched all time high again.
Congrats to all old timers and newcomers alike.
The next year will be eventful for sure.
Good luck to all AYTU holders. I don't own stock in this Company but I have a large stake in Acerus - the owner and develloper of Natesto. They are about to roll out world wide and I hope AYTU and all the other licence holders will do well.
Nice little bump up today. Hopefully we’ll get good news to solidify the pps soon.