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This stock is cursed
I hope the CEO is very embarrassed tonight. And that he might have learned a lesson.
With all due respect... delayed ?!?
The CEO announces a forthcoming announcement of a cc only to "delay" the real cc a few days later. I was hoping for a conference call with news but I got a voice mail.
Cellceutix Announces Details for Upcoming Investor and Shareholder Presentations
BEVERLY, MA – April 19, 2017 (GLOBE NEWSWIRE) Cellceutix Corporation (OTCQB: CTIX), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory and antibiotic applications, provides additional details for upcoming investor and shareholder presentations.
On the morning of April 20, 2017, at 11AM Eastern (EDT), a pre-recorded presentation, audio and corresponding slide deck, with particular emphasis given to Brilacidin interim trial results in Inflammatory Bowel Disease and Oral Mucositis, will be made available at the Events and Presentation section of the company’s website, linked to below:
http://www.cellceutix.com/new-events-and-presentations/
Additionally, the Company is fielding investor and shareholder questions in advance of a live conference call, scheduled for June 8, 2017 at 11AM EDT, as follow-up to the next quarterly report (10-Q) to be released in May. Questions for the June call may be submitted in advance by emailing conference@cellceutix.com to be received by June 1, 2017. Dial-in instructions for participants will be announced one week prior.
Do we know if the CC will be a real call with questions this time or a pre recorded hybrid ?
Long timers know the many powerful
properties Scenesse holds but this article underscores how likely the implant is to alleviate / cure MS and other neuro inflammatory diseases.
They even specify that they are indeed using Scenesse in the lab.
Dr. Wolgen is fully aware of this as per the AGM but we won't see Clinuvel pursue other indications than dermatology and UV-related disorders.
Licensing, however, seems more and more plausible.
http://stm.sciencemag.org/content/8/362/362ra146
I've never really been a fan of US punctuation and imperial metrics, But sure, And sorry for the confusion,
AGM held in Australia. Canada, Switzerland and Australia are up after FDA approval in the US. Lots of great info in the following links. Kudos to management for job well done and for addressing shareholders questions and concerns. 2017 will be a(nother) great year.
Chairman's Letter
http://www.asx.com.au/asxpdf/20161128/pdf/43d86l2z8774rx.pdf
Canada's next. What are the EPP numbers in Canada?
Investor Presentation
http://www.asx.com.au/asxpdf/20161128/pdf/43d87hv9tpfj5g.pdf
An attempt to put a value on Clinuvel
ValueFox and other posters have previously posted very level headed valuations and mine is
merely and attempt to add to the discussion. I believe in my numbers and my assumptions but
they are as such only an educated guesstimate.
Shares out: App. 47.725 m
EPP:
Prevalence is said to be 1:75.000 to 1:200.000.
Many patients are know by the specialized porphyria centers in Europe and the US but due to general unawareness of the conditions many patients are believed to be undiagnosed. Roll out of Scenesse will most likely change that.
Europe: App. 4500 patients.
I will use a price per implant of $17.000 USD and an average of 3 implants per patients.
That's $51.000 per patient or $229.500.000 in revenues for 4500 patients.
Put aside 25 % for expences, taxes etc. (conservative) and Clinuvel is left with $172.125.000.
That's $3.66 EPS. Apply a ratio of your liking - I'll go with 20 - and the pps would reach $73 USD for EPP in Europe.
Add US FDA approval wich I consider a shoe in, and Clinuvel should be able to add 50 % to that number resulting
in a pps on the sunny side of $100.
In my guesstimate, 100 EPP patients are worth $1.6.
Now, roll out is extremely slow but I believe it will catch on and that Clinuvel will reach
1000 patients in Europe fairly quickly and maybe already 2H 2017. That should result in a fair price of $16 pps.
With possible roll out in the US next fall and a much quicker roll out here, 1500 patients is not unrealistic
by EOY 2017. That's $24 pps in 12 months or app. 200 % upside from where we are today.
Again, roll out can continue at a glacial pace or it could suddenly catch on. I hope the latter will be the case.
These numbers are ONLY for EPP, which is not a fair valuation. Vitiligo, other indications and label extensions
should also be part of the valuation.
VITILIGO:
Prevalence is app. 50 m. world wide. Let's assume that the price per implant drops significantly when such a broad patient population will have access. But even with a very low price per implant of let's say $500 and 5-10 required implants in the combination therapy that's $2500 – 5000 per patient.
With app. 3.200.000 Vitiligo sufferers in the US let's say that 5 % will be treated with Scenesse.
That's 160.000 patients yearly and between $400 – 800 m. Clinuvel will most likely require a partner to perform the last Phase III trail and to bring Scenesse to market to treat Vitiligo, so let's assume that Clinuvel can keep 40 % (on top of up fronts and milestones that I leave out just to be conservative.)
That's $67-134 pps for Vitiligo after full roll out. At this stage and with considerably uncertainty I think it's reasonable to ascribe a 10 % probability of success. These assumptions should result in a value off $6.7-13.4 pps for Vitiligo risk weighed. Today, the market doesn't ascribe any to Vitiligo at all which I think will change as soon as a partner is brought on board.
With 1000 patients and a 10 % risk weighed valuation on Vitiligo I think Clinuvel is worth $23 pps.
Add label extensions, Scenesse Enfance and new indications and the price could go much higher.
There is always risk, and biotech is notoriously the most risky investment out there. I do believe, though,
that Clinuvel is extremely de-risked and that the potential up-side is greater than the potential risks.
I see a pps. between $10-20 in 2017 and I won't begin selling any of my shares until we reach $40 which I
think will take a few years. Is $100 possible down the road ? I think so.
I just found out that the conference call really just is a pre-recorded presentation. The fact that they wanted the questions on before hand was already bothering me. Now, I don't really see what value there is in this.
Yeah, I thought the same. They must be very confident about the FDA.
I assume that a PDUDA in August - November is realistic now. Pretty quick if they pull that off. I see very little risk that the FDA comes back with a CRL turns down the NDA.
Thanks. And the pre-NDA meeting with the FDA is today.
Although I am a big advocate for better PR, I do see why PW would want to keep Clinuvel's of the limelight. They are operating in a field where many competitors could hurt them and I believe that that is also why the tugged the topicals away in Singapore with Mr. Fun and the Captain.
I would love to see the AGM webcast and to have investor's conference calls. But I don't believe they have the desire to do so and if we are moving in the direction that I think we are, I'm currently not going to complain about it. Money talks.
Yes. Very close to my $6 m estimate.
The potential is so obvious. $5.7 with only 4 countries online and with a small initial group of patients receiving the implant in those countries. If we reach 20 European countries and get to treat the patients who are standing in line to receive Scenesse at this moment, then we could easily see $100 m per year in Europe for EPP alone. Add the almost certain FDA approval and we could arrive at $150 m per year. Add partnership for Vitiligo, subsequent FDA approval and label extensions within 3-5 years and the sky is the limit. Event the risk weighted valuation of Vitiligo once a partner is on board could be substantial. Clinuvel is in track to become a +$50 stock within few months / years.
A lot of chatter on other boards about a possible taker over offer or an imminent partnership deal.
I truly don't hope an acquisition will materialize. $10-15 right now would be a disappointment.
A partnership deal would make sense and be beneficial. FDA approval for EPP seems like a shoe in and after the pre-NDA meeting in November the Vitiligo program should get more attention. Clinuvel has stated numerous times that the EPP and Vitiligo programs are intertwined in the US, most likely meaning that a majority of the data package with regard to safety etc. will be the groundwork in a forthcoming NDA for Vitiligo. Therefore, the submission of an NDA for EPP at a stage where everyone anticipates the FDA to approve also constitutes a good opportunity for a partner to come in and take the lead on Vitiligo.
The chairman has been touting an enlargement of the "group" lately and I believe that a such is imminent. The question is which form it will take.
The recent rise in share price is nice but does in no way reflect the true value of this company. A buyout would be tragic. A partner would be welcomed.
Ought to open just below $7 this morning.
Yes, welcome to a beautiful day. And congrats to all who came early. And to those who're going to join. This is just the beginning.
Notes - FDA Meeting - EPP
Meeting hours 10 AM - 4 PM
Location: FDA, Silver Spring
Town Hall style. The biggest turnout in FDA history for this kind of meeting.
5 people with EPP will comment on their daily life with EPP.
KENDALL MARCUS, Director, FDA
Dr. Kendall Marcus began by saying that they would not be discussing any
particular drugs or regulatory paths for any drug related to EPP.
It’s all about risk benefit. We are here to hear the voice of the patients.
HENRY LIM, MD
Epidemiology and natural history of EPP.
Prevalence: Europe generally 1:100.000 / Japan 4:100.000
U.K.: 389 subjects identified
Median age: 34
Mean age of diagnosis: 12 yrs
Sunscreen does not protect well because EPP is triggered by visible light
JOYCE TENG, MD, Stanford
(She is the one using Cimetidine for EPP)
Treatment approaches for EPP
Talking about Beta-carotene. Doesn’t work, she says.
She encourages physical protection. Clothing, tintet windows etc.
SCENESSE
Scenesse: Very exciting peptide.
Binds to MC1R-MC5R (!)
Phase 3 trials underway ?!? No EPP trial is ongoing. What is she talking about ?
She refers to NEJM report.
Results: Pain free time improves with treatment.
Limitations: Invasive
Does not provide visceral organ protection
Lack of safety in children
Long term implications. What will increased time in the sun do ?
Does not protect the liver.
CIMETIDINE (OTC) for children:
Case study of 3 pediatric patients.
Cimetidine 30-40 mg/kg po divided BID.
Results: Rapid improvement in pain and photosensitivity <4 weeks.
No adverse effects.
Quite amazing, she says. Liver functions normalized very quickly.
Positive global feedback from patients.
Non invasive.
PATIENT AND CAREGIVER INPUT
Symptoms and treatments
5 EPP patients describe their pain. It’s excruciating, as we all know.
The first patient (adult woman) participated in the US Scenesse trial. It was absolutely life changing. She could now for the first time stay outside and do normal stuff with her family and friends. Even being out 30-60 minutes was life changing. It is very hard to spend 6 months living normally and then go back to the dark.
Second patient, 11. yrs old. Can only tolerate 10 minutes of direct light before a reaction.
Reactions last up to 5 days. Very painfull. Can’t do anything outside. Her twin sister gets to play outside. (My comment: This is heartbreaking to listen to). She wants a treatment that will allow her to stay outside all day. Cimetidine DOES NOT HELP this little girls, she said (!)
Third patient. Adult man. Describes the pain. It doesn’t go away ! Every day he fells incomplete because he can’t pursue his dreams. It’s like putting your hands in boiling water. He gets overheated in the summer because of the clothing. In the winter it’s easier. He joined the Phase 2 Scenesse trial. The treatment helps. It was very hard to push himself into the sun, so he tried a little bit at the time. The recovery was amazing. He asks the FDA for help. Emotional pain is worse than the physical pain.
Fourth patient. Female teenager. She is crying while talking. The curtains in her house are always drawn. The only thing she can do is cover up. There is no medicine in the US that helps. She is very emotional. (My comment: Come on FDA - help these people). She is only 16 and she knows that Scenesse is for adults. But she is so excited that when she turns 18, perhaps she can have it. She wants to go to the pool in the day light. This girls was very emotional
Fifth patient. Adult female. She had a 5th grade teacher who didn’t believe her. Caused her trauma as a child. She is in a reaction from traveling to the meeting. Even the computer screen gives her a reaction. But it is worth it. Even when covering up she gets a reaction. Imagine telling your kids to not touch you, because it’s too painfull. When she has a reaction she wants to rip her skin off. Her kids don’t have EPP so they can be outside. She misses out of all their events. She is also very emotional. She can’t do anything with her family. It affects her friendships. She can’t attend work events. She is a trauma therapist but because of her EPP she can’t put her skills to work.
LARGE GROUP DISCUSSION
EPP patients describe their pain. There aren’t words, one says. An other says that it’s like cutting yourself and burning at the same time. A parent says that the pain her child suffers is so severe that the child has walked around with a broken leg without even knowing it because the EPP pain overshadowed it.
AFTER LUNCH:
The moderator asks how many are traveling to Europe. There is a show of hands. Not visible though. They ask what patients do to treat the condition. 0 % say Cimetidine / Tagament. 92 % say Protective clothing or masks / lifestyle changes.
A gentleman says that he tried Cimetidine and that it did nothing. A woman says that her daughter took it for a year and that it did nothing at all. 3 people in all say that Cimetidine was not meaningful. (Why did they have Dr. Teng up there for 20 minutes talking about Cimetidine for so long time when it’s not meaningful ???)
A gentleman was in two trials. Second time around he got Scenesse. It helped him so much that he could skip the mask and didn’t have any reaction. Very thankful for that. A woman with two adult kids with EPP thanks the FDA for listening. She wants the FDA to understand that they are talking about pain management - that is what people is asking for.
A gentleman says that he tried beta carotene and it did nothing. He got Scenesse and didn’t have one single reaction. He even got a sun burn and loved it. The following summer was horrible because he was no longer on Scensse and returned to be able to do nothing.
Another gentleman was in the trials and is now traveling to Europe. It is beyond his wildest dreams what Scenesse is doing for him. It has taken him 1,5 yrs to understand what he is able to do now. He is amazed how much time he can now spend outside. This is what he is looking for in a treatment. It has surpassed his wildest expectations.
JT’ mother: JT has been fortunate - has done 5 trips to Switzerland. Her prayer is that everyone with EPP will have access to Scenesse. It is life changing.
They now talk about how to re-learn a behaviour.
A woman talks about Scenesse. She has been to the beach for the first time because of Scenesse.
OVERVIEW OF FDA REGULATORY PROCESS
This I didn’t listen to. Had to take a call.
CHALLENGES IN CLINICAL TRIALS DESIGN FOR EPP
Dr. Elizabeth Minder
We have cared for more than 100 patients, she says.
Talking about all the challenges.
Pigmentation may produce a bias in a trail.
Afamelanotide is described as life changing. A compelling evidence of
efficacy.
Elizabeth Minder: We have more than 500 patients in Switzerland (?)
PANEL DISCUSSION
Talking about the willingness to participate in future clinical trials.
Why do they talk about future trials ? Are they planning more phase 3s or
perhaps a phase 4 ?
Now Kendall (I think) says that it’s about building on the results they have. Like in the treatment of HIV back in the day. Also for pediatric patients. What can be made available to them ?
Safe and effective dose ? That is the purpose of the discussion, she says. She has heard from many today that they want for the children to benefit. That will be a challenge finding a treatment. (It sounds as if my worries about why they are talking about new trials are not warranted. This is for the children and possible future trials.)
DR. Desnik says that the most important in a trial design is to understand the natural history of EPP. When you’re burned for the first time you will have a inherent fear of the sun and will try to stay out.
Dr. Minder: We have a decade of experience in measuring efficacy in EPP.
Dr. Teng: We need to hear what the patients want and that is to spend more time in the sun.
Patient reported outcome.
There have been many trials. And people believe it works. That’s the best criterion I can think of, says one of the experts. Strong support for Scenesse.
Dr. Marcus: We hear you. But we need to be able to put it on paper. So far we have only been able to measure small levels of benefits. We have to measure it all to demonstrate efficacy. She is also referring to all the letters she has received from the APF.
Dr. Minder: We have to do as we did in the phase 3 trial. You cannot use average on day. But if you use integral you get a more adequate view on efficacy. There is a strong increase in sun exposure time. We will not find anything better.
Dr. Marcus: I don’t want to stop with one solution. Someone in the audience shouts someting.
It sounds as if it’s about Scenesse. Dr. Marcus: This is not a statement about a drug. There has to be a certain amount of… Believe me… I understand the frustration. We’re really trying to focus on… as I said… pediatric clinical trials might be a trial where you have 5-10 patients….
This is not commentary on anything that has already transpired. It would be great if we could all work on a path forward.
Dr. Lim: I’d also like to se more robust endpoints. But nobody wants to get burned. They have a fear. How do we do it better ?
I missed everything from here till the end. Please fill in.
Long timers also know Uho and that I respect him a lot. This is a recent post from GG:
The high number of $9 billion for Clinuvel market capitalization divided by 47,000,000 shares would be $192.00 Per share just based on Homm's vitiligo assertions.
I actually do not see the sales potential of Vitiligo near this nor am I of full confidence of Scenesse being a therapy for ALL vitiligo patients. And that as a treatment it has various areas and gradients of therapeutic success in Vitiligo. Phase III will be telling a lot.
His estimate of $70 million for a vitiligo phase III is a reminder that FDA will require somewhere between 500 and 10,000 Vitiligo patients.
I have more confidence in the below for photo protection and free radicals first and secondarily DNA repair and thirdly inferences of gene expressions and pathways to prevent and stop from growing and or kill in each of these cancers or disorders leading to cancers.
Melanoma $5 billion
Squamous, basal and other skin cancer $5 billion
Xerdoma Pigmentosis Xp, Progeria $500 million
Solar urticaria, polymorphis light eruption, actinic keratosis, psoriasis and a myriad of skin disorders $5 billion
Without more evidence and trials to determine if unknown signals, or unknown pathways or counter cascades that may interfere with a Sceness drugs mechanics of actions inferred with what appears to be the endothelial and epithelium cells that are biologically similar to keratinocytes I have high confidence that in a majority of patients in a majority of those patients with most cancers (there are about 106 types of cancer) that Scenesse will prevent and likely stop and then likely apoptosis (kill) cancerous cells in
Oral, esophagus, stomach cancers. $2 billion
Intestinal, colon cancer. $2 billion
Lung cancer. $5 billion
The immune system cancers and blood cancers are more complex and less is understood, but the involvement of melanocortins in eukaryotes is ancient and there are substantial links inferring a complex affect with less understanding of side effects from melanocyte stimulating hormone that is likely very therapeutic.
All blood, lymphatic and immune disorders inclusive of cancers in these cells. $10 billion
I have strong confidence of high likelihood of Scenesse therapies in the eye based on well based studies, abstracts and pathways. As well as the melanocytes stimulating hormone natural occurrences in the eye.
Macular degenerative retinal disorders and eye homeostasis and diabetic complications affecting the eye. $5 billion
I have strong confidence Scenesse will affect the collagen and fibrous disorders, there is something positive here, but it is not clear of many peripheral pathways and intervening pathways interrelated, as is usual for all drugs. To much and to little is both bad as in cystic fibrosis but the melanocytes stimulating hormone appears to be the homeostasis goldilockes here as well. $5 billion
Bone, teeth, tendons, joints, synovial fluid, discs, cartilage and the osteoclasts, osteocytes, osteoclasts and importantly the effects on osteoblasts is building solid evidences that a Scenesse will have positive leanings of therapeutics. But it must be a perfect homeostasis balance with so much left to be understood of parathyroid signaling, calcium balance and all related osteopathic disorders and arthritic inflammation affects and long term counter effects. I think it is going to take a lot of time with studies but is leading to indications of positive therapies. As with all drugs and what is indicated here with melanocyte stimulating hormone or a Scenesse is how the age of a patient, the state of how many stem cells are left, state of the organ if it can not replenish it cells if signaling by a Scenesse, and can a Scenesse proliferate more stem cells in a older human. As most areas of bone and joint disorders are in the aged.
For teeth, the French did the melanocytes stimulating hormone tooth study on rodents because of the in common pathways. But I give no value for Scenesse in teeth as it is too liitle with too far to go. Though the recent study in msh relative to periodontal and tooth ligaments is very positive and pathway logical.
If it plays out with homeostasis long term value $20 billion market to alleviate bone, arthritic, spinal and joint disorders.
Tooth regeneration $5 billion
Evidence is there and building on the anti-inflammatory and neuronal damage remediation in strokes as well as chronic inflammation and immune cell reactive imbalances in all neurodegenerative disorders as particular I have cited abstracts relative to the major ones as in multiple sclerosis, Amyolateral sclerosis, Huntingtons, Parkinson's. There is evidence that several of the theories of Alzheimer's that melanocyte stimulating hormone will stop formation of amyloid plaques and or accentuate the mitochondrial protein flush out of neurons. $10 billion to $20 billion.
The numerous indications implying of melanocortins stopping or hindering development of inflammation and sclerotic hardening in arteries and capillaries as well as stopping or hindering development of immune cell response and plaques is astonishing and would be a most profound therapy worth $20 billion
The effects are there in other organs receptive to melanocortin stimulation as well as many endocrine cells that are gathering more evidence particularly in eating and fat and energy and the pancreas and kidneys and brain. To soon to make a guess.
In its most simple aspect that Scenesse counters free radicals oxidation AND instigates Deoxyribonucleicacid repairs in just what is indicated so far in just some skin cells and leaving out the other cells where the evidence has not accumulated enough is going to be world changing not just in human health but profound. If it does not have a long term unknown as of now and no pathway implication side effect. If such Achilles heel does not present out, then Scenesse is already now a proverbial Fountain of youth drug.
Scenesse is proving to protect the cell from damage, and if damaged to accentuate repair of the damage, and if damaged to senescence the cell, and if cancerous to apoptosis away the entire cell. Being that this is what's happening to a human at any moment while alive and the damage is cumulative anyway, then Scenesse will let ones cells live longer, and its cellular job and organ live and stay healthy longer. Evidence is strong that Scenesse will maintain ones youth and appearance much longer and extend ones life with more healthy years. A good problem to have for Clinuvel is that if one is on one therapy for Scenesse they do not candidate themselves later on for heart or stroke or cancers and a younger person taking Scenesse would not be in the usual epidemiology statistics as of present trends if in theory for heart or stroke. I think with stem cell research and now Crispr-Cas9 and these technologies evolving will make one live in theory indefinitely, but a implant as a Scenesse would still be a valuable signaling. Without a stem cell or Crisprcas-9 evolution (which is lookin very certain) or better developments in telomere repair or replace or enhancements I do not know if there could be a better way then melanocortin therapy to interfere in a good way with ageing.
Numerous studies have attempted to find THE GENE that can extend life. So far it's looking like there is no one gene. And it may be 150 or so genes that have been candidates because of differences in older verses younger or in twins studies. And these 150 candidate genes even in there interactions are not leading to a key to understand aging. Too many transcription factors and gene shutdowns complicate as one gets older. It maybe more of expressing pathways that can be more helpful candidates for life extension with health lasting longer.
The leading theories of ageing with evidentiary studies point that telomeres Shortening and oxidation leads to ageing.......and Scenesse is positively involved. A breakthru in telomerase initiation in cells would be a positive if controllable. But that's also the protein that makes cancer cells live forever and not die, until of course they kill the human by taking out organ functioning.
So as the potentials of Scenesse melanocortin therapeutics morph from basised in fact theory's to realities in the years ahead I think I can easily agree with Florian Homms $9 billion assessment of Clinuvel future market cap. His assesmt that Clinuvel is a takeover target I agree, but I am wondering what I do not see in that the ASX regulations could let a hostile to Clinuvel happen. And any attempt that gets close to 90% would by the fact raise the stock price tremendously to where very few stockholders would be upsetting. Oh I left out one more potential therapy for Scenesse worth $2 billion ...................a cosmetic tan.
News from the U.K. NICE now evaluating Scenesse as a STA.
Estimated number of patients seems high: 1300. All in all the process is going forward and the British patients might have Scenesse next spring.
https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisals/Block-scoping-reports/Batch-47-block-scoping-report.pdf
Long timers all know who Florian Homm is. If you don't, Google him. He has a questionable reputation and history indeed, but he has always had a view on Clinuvel that corresponds with my expectations for the future.
I agree with pretty much everything he writes in this new article about Clinuvel originally written in German and here Google translated into English.
Enjoy.
By Florian Homm For years I have been receiving regular inquiries about Clinuvel, in English and in German. Since I can not possibly answer these mails, I comment on this company at longer intervals. Certainly, I feel very much connected to this company. Clinuvel is one of the most sensible companies I have seen as a financier in my long history. My 1st update came in my best-selling autograph (head-hunting, Rogue Financier, Munich publishing group), in which I recommended Clinuvel at a rate of 1.20 Australian Dollars (AUD) to my readers. The 2nd update came after the failure of the Clinuvel takeover by Retrophin. At that time the price had fallen from about 5.20 AUD to 2.40 AUD. Many investors were extremely insecure. And that is why I decided to express my positive opinion on this pharmaceutical / biotech value. You can find these posts today in the most important forums on Clinuvel in English. For some time now I have received a lot of inquiries. "What should I do after the strong course development," is the most common question? Instead of answering these questions one by one, I share my personal opinion on this title about the board week. What is important is that you should know that neither I nor my family have Clinuvel shares. My employer holds 25,000 shares. However, since the spring of 2014 he has not bought or traded any further shares. In principle, I urgently recommend all alternatives, to consider alternative opinions and to make their own opinion. What follows is my purely personal assessment. This can, of course, be wrong. I do not currently benefit from a positive course development. It is important to me that this promising company will prosper and reduce the suffering of several million people suffering from various skin diseases (EPP, vitiligo, skin cancer). I hope that these updates will be superfluous in the coming years. It would be desirable if a sound research on this company were made by credible, professional and conflict-free analysts (Research Coverage). I am very grateful that I could be involved in the positive development of this company and thank you for your attention. Important note Although the stock market capitalization of Clinuvel has now exceeded the mark of 300 million Australian dollars, this value should be subject to limits on purchases. The daily trading volume fluctuates very strongly and is spread over exchanges in Australia, Germany and America. Background I have been intimate with this internationally active pharmaceutical company for more than a dozen years. Originally, I discovered this company. As she tried to bring a skin darkening against sunglasses to the market. At that time, Clinuvel was still called EpiTan Limited and was run by promoters. The company was almost broke, and we were then at about 0.30 AUD, far below market value. Then the company was relatively brutally, but very effectively restructured. Almost all leading employees and more than half the board took their leave. The current CEO, Philippe Wolgen, was recruited and thus began the actual success story. Instead of continuing to deal with the untrustworthy sunglasses and tanning work, Wolgen began to explore serious medical applications for Clinuvel. The combination of Homm as a successful investor and success as a talented and meticulous pharmaceutical manager was honored by the stock market. The stock price of the stock increased by a factor of forty in a very short time to 12 AUD. In order to implement the vision of Wolgen, we were collecting about 80 million AUD for Clinuvel at other institutional investors. After I went into exile in autumn 2007, many investors lost interest in Clinuvel and the stock fell below 1.00 AUD. For a long time, the stock valuation was below the present value of the company. In November 2012 I returned from my exile and recommended the stock Clinuvel in my bestselling bounty hunting at a rate of 1.20 AUD with the remark that the company would either scientifically and financially succeed or that another pharmaceutical company Clinuvel friendly or hostile Would take over. Exactly the latter happened. After my involuntary vacation in Italy (15 months of delivery in Pisa and Florence), the company Retrophin launched a hostile takeover offer under the aegis of its highly controversial CEO Martin Shkreli. The share rose by 430% to 5.20 AUD. I had hardly been released from the Italian custody, and this overwhelming battle had already begun. During this time, for the very first time in my life, I advised a company as a so-called White Knight against Shkreli and his friends. I got a lot of praise, but I did not earn a Eurocent. The result is known. Shkreli failed miserably and Clinuvel continued her research. In November 2014, the approval of the critical Clinuvel drug (SCENESSE®) was passed by the European authorities against extreme light sensitivity. The most important milestone in the company's history was achieved. Update Annual Report 2016 The latest research report on Clinuvel dates back several years. In an environment without any professional research, the market takes a relatively long time. To understand important data and interpret the messages between the lines correctly. Organic sales rose by an impressive 97% to AUD 6.42 million, while losses were reduced by 70% from 10.4 to 3.2 million AUD. Very smartly, we see the Clinuvel company strategy to implement a uniform price in Europe for the EPP treatment with SCENESSE®. The 30 per cent rise in prices in recent days does not adequately compensate for this good development. The solvency of Clinuvel also improved significantly. Cash rose from 0.6 million to 13.8 million AUD, or 30%. We are particularly aware of what CEO Philippe Wolgen has indirectly communicated in his CEO's Outlook. The Clinuvel CEO expressed confidence in the approval by FDA in the US of SCENESSE® in the EPP area. He also spoke positively about the developments and outlook of SCENESSE® in the treatment of vitiligo. Anyone who knows something better about Philippe Wolgen will know how to take that cautious optimism. Wolgen has always been a very reserved CEO. The Wolgen premise is still "underpromise and overdeliver" (little promise and much more deliver). It is precisely for this reason that we find the subtle expressions of Philippe Wolgen so direction-oriented. The Opportunity Although Clinuvel is now an index on the Sydney Stock Exchange, there is still no research on this title. Neither in Australia, Europe or the USA. The share also trades on various German exchanges and on the Nasdaq. The exchange turnover leaves something to be desired, but the shareholder is absolutely first class. Among other things, Fidelity, the Rockefellers, Philippe Wolgen as well as other brilliant investors in the share register can be found. SCENESSE® has several applications. Not only for extreme light sensitivity (EPP, also called vampire or Hannelore cabbage disease in the Volksmund), but also in the treatment of vitiligo (white spot disease). I would not like to mention other applications here in more detail, but in at least two other areas, I consider a long-term valuation potential of not less than US $ 1 billion realistic. We see the maximum valuation potential of vitiligo at almost fantastic 5 billion US dollars or more. But before we bring our motivation to this insane assessment, we would like to evaluate Clinuvel on the basis of EPP. Currently there are approximately 47 million Clinuvel shares. At a current exchange rate of 6.32 AUD, a stock market valuation of around AUD 300 million is generated. This corresponds to a valuation of around 205 million euros or less than 200 million dollars. According to various estimates, there are between 4,000 and 10,000 people who suffer extremely from EPP and other similar light-sensitivity disorders. The treatment costs are considerable. Although it suggests that Clinuvel's EPP treatment could cost over US $ 70,000 a year, we have estimated a much lower value of US $ 50,000 in our calculations. In addition, the approval of the American health authority (FDA) is still pending. We calculate the probability of SCENESSE® approval for the USA at over 80%. We categorically categorize the market as a whole with a maximum of 4,000 patients. Overall, we are confident that at least 2,000 patients will be treated with SCENESSE® by mid-2018. This results in a very conservative sales potential of US $ 100 million. In the case of a commodity use which is very small, a profit potential of US $ 80 million would be conceivable (US $ 60 million after tax). This would correspond to a P / E ratio of less than 3 for 2018 in the current stock market valuation. A company such as Clinuvel, however, should be valued at a P / E ratio of 20 to 30, giving a profit potential of 6 to 10 at the current price. The following link provides you with the Clinuvel stock chart and other useful company information: http://www.clinuvel.com/en/investors/investing-in-clinuvel/share-price However, the combination therapy for vitiligo is much more significant for Clinuvel. There are 50 million vitiligo patients worldwide. Every year there are at least 1.2 million Vitiligo treatments. The previous vitiligo treatment results from clinical phase 2 are promising. I advise every prospective buyer to deal more intensively with this topic. Especially by visiting the Clinuvel website. It is quite conceivable that the Clinuvel vitiligo combination therapy will be the "standard of choice" in treatments of vitiligo patients. With a 50% market penetration and a low treatment price of only 5,000 US dollars per treatment, a turnover potential of 3 billion US dollars is generated. This calculation is not based on insane assumptions, but has been confirmed by the world's leading dermatologists. We do not want to and will not start from any net profits, but a turnover rate of 3 times for a large pharmaceutical company would by no means be offset. This results in a potential valuation of US $ 9 billion against a current stock market value of less than US $ 200 million. The estimated cost of an extensive Vitiligo Phase 3 trial is approximately $ 60 million. Risks In general, the exchange risk applies. Since we consider the overall market to be very risky (see also my book Endspiel, Munich publishing group), a pearl like Clinuvel should not be spared in a stock market crash. In our view, the greatest short-term risks are that the FDA does not approve SCENESSE® as a treatment for EPP. We see this risk at a maximum of 15%. Vitiligo can not be automatically approved by an author. Here we see the chances at 50%. In addition, Clinuvel has to raise its treasure chest for this project. This could lead to a clear dilution of the number of shares. With today's share price, the number of shares would increase by about 20 to 25% in order to finance the upcoming vitiligo studies. Also, you can not assume without risk that Clinuvel will be able to translate the estimated annual turnover for the EPP treatment of 50,000 US dollars per patient across a broad corridor. It is also not certain whether this price level can be maintained. The biggest risk at Clinuvel is a takeover, which allows a quick profit, but the investor takes the chance to multiply his investment in the medium term. This is why Wolgen has been working feverishly on a shareholder structure since the retrophi- nate attack, which, through the participation of loyal and very knowledgeable shareholders, enables him to ward off a further takeover attempt. Several small capital increases have enabled Wolgen to mobilize highly professional and reliable shareholders who share his vision of Clinuvel as a future multi-billion dollar pharmaceutical company. This could mean that Wolgen is not interested in professional research coverage and close collaboration with investment banks. These defensive defensive measures partly explain the insufficient investor and public relations activities. It is questionable whether he can once again fight off a hostile takeover. With a takeover rate of 12 to 15 AUD, even strong hands could become weak. From our point of view and my experience as a long-term corporate raider, a high share price and a fair company assessment are the best defense against grasshoppers and corporate spies. On the other hand, Wolgen, without the slightest doubt, is a first-class manager and remarkably good chess player. Why should he not first consolidate his shareholder base at very low valuations, and only then, in accordance with very good company announcements, would the Clinuvel story be made public through various Wall Street banks? In all fairness, one has to admit that he leads his company transparently. The website is quite informative. Clinuvel is a trademarked title. Larger investors are advised to contact the company if they wish to acquire blocks. Since leaving the company as a Clinuvel investor, the company has always made it possible for very wealthy private investors and institutional investors to participate in smaller capital increases in millions. Conclusion Despite considerable risks, we do not know any other biotech or pharmaceutical investment, which could potentially increase tenfold over the next 3 to 5 years. Even more rare are promising pharmaceutical and biotech companies of this kind who already have an attractive, approved product and significantly increase their product sales every year. This means that the risk is limited, at least from a fundamental point of view. The undervaluation of the Clinuvel share, which is still absurd from our point of view, is based solely on a shortcoming of first-class investment research, non-existent IR activities and, consequently, a very low level of awareness of the company in the investor community. Nomura already rated the stock at 12 AUD per share about 9 years ago. At that time, there was neither an approved product nor sales, nor any credible vitiligo studies and data. Today you will find a positive entrepreneurial milestone after the other on the Clinuvel website. Clinuvel can hardly prevent the investment community from drawing attention to the company. An FDA decision on EPP will be issued no later than the next 10 months (as of October 2016). With other positive Vitiligo messages is to be expected in the same time window. Ultimately, we believe it is likely that a well-known and respected investment bank will publish research on Clinuvel over the next 12 months. I strongly urge you to read the 2016 Annual Report of Clinuvel meticulously. More importantly, what is between the lines. For me as a successor to the Wolgen, the cautious optimism of the CEO is a clearly positive announcement. Wolgen is known as an archconservative CEO and auditor. This is the reason why the price of the share has been following positive developments for almost a decade. Despite the recent price rise, there is no change in our medium-term positive assessment. Rather, we are inclined to raise our already unusual medium-term price target of 35 AUD. We will definitely stay on the ball and will closely monitor upcoming developments. Michael Uhlemann, the owner of "The Second Opinion" holds 25,000 shares in Clinuvel. These shares were acquired over several years. Last year in spring 2014. PS: Risk-averse investors may consider hedging a Clinuvel position with an inverse biotech ETF (for example, the ProShares Ultrashort Nasdaq Biotechnology ETF (BIS)), or by short-term positions on equity indices or overpriced individual values. Persistent investors can try to buy the stock in setbacks. The stock is quite volatile. In all investment decisions, we advise inexperienced investors to invest in their knowledge and to seek professional advice. Your Florian Homm www.florianhomm.org www.diezweitemeinung.eu Price: AUD 6.32 in October 2016 Stock market capitalization approx .: AUD 300 million Long-term target price: 35 AUD Long-term incentive (simple): 538% Risk (simple): 50% CUV Website: www.clinuvel.com Stock Exchanges Australia: Sydney Stock Exchange, Price AUD 6.50 Germany: Munich, Frankfurt, Berlin, Hamburg, Stuttgart USA: NASDAQ www.vorstandswoche.de Securities: Clinuvel Pharmaceuticals (Sponsor ADR), Clinuvel Pharmaceuticals
Will this share multiply again ?: Guest contribution by Florian Homm Wallstreet-online.de - Full article at:
http://www.wallstreet-online.de/nachricht/9003834-aktie-nochmals-vervielfachen-gastbeitrag-florian-homm
Meeting agenda for the upcoming FDA meeting:
http://www.fda.gov/downloads/Drugs/NewsEvents/UCM525196.pdf
Clinuvel schedules pre NDA meeting in November.
http://www.asx.com.au/asxpdf/20161013/pdf/43bydfdws130w7.pdf
Post by CUV101 of HotCopper:
I’ve had a couple of reads of the Chair’s newsletter. Wolgen and McLiesh have made an art form of the waffle. I am left wondering exactly what our Chairman was hoping to convey with this.
I think that the only thing that can be reliably concluded is that German distribution has not started yet. This is disappointing as Germany is likely to be the biggest market outside of the US. I understand the delay is due to privacy concerns with the disease registry. With peak Scenesse season being in the Summer, it is now probable that no (or very few sales) will be recorded in Germany until the next Northern Spring - 6 months. This will have no effect on the end game but will result in loss of momentum. Long term Clinuvel investors will not be surprised with the missed target that was previously announced to the market in June this year for a July start!
“We have now agreed to explore ways to expand the Group with the aim of being able to pay for the mandatory development of a paediatric formulation in EPP and SCENESSE® for vitiligo.” This statement seems to have opened up the question for ongoing funding for vitiligo. Although the term “Group” is used for the first time I really don’t think too much can be read into it. Around the time I first got interested in Clinuvel, ex director Jack Wood was in a YouTube clip speaking of a “platform” and various value adding strategies including deals with big pharma. These were expected to be made in 2010. It is worth a watch. It is just frustrating for all concerned that still 6 years later there has been no development in this area. As he alluded to new indications will become known during the development process. As an example no one would have considered successful dementia trials in an animal model with the same molecule that was originally developed to prevent skin cancers and is now approved to prevent symptoms in a disorder of haemoglobin synthesis! If any deal is done then using the BLS joint venture as an example it is likely to be unconventional and non value adding!
Our chairman also informed us that CUV9900 was not yet ready for human trials. This molecule was announced to the market as an exciting follow on compound over 6 years ago! The pace of development here can not be blamed on anyone else.
The pathetic telling off to shareholders from the Chairman suggests that he may be getting tired. If Clinuvel had honest and direct communication with shareholders then this would clearly not be necessary. As to suggest that this could slow down the regulatory process then this is just dishonest. Especially when some of the real delays to the regulatory process have never been disclosed, for example an inability to conduct clinical trials! Perhaps the Chairman should re read his previous communication to shareholders to see just how honest he and his team are in their dealings with us! Only 3 weeks to go to the FDA Scientific workshop on EPP, open to all and via webcast. According to Clinuvel “invitees only”, just another honest "mistake" in the best interests of Clinuvel!
Mr McLiesh also advises us that Clinuvel’s key professional investors have been increasing their stake in the company. I assume that this is Sean Parker who without buying more would now be below 5% due to dilution and would have provided notice of ceasing to be a substantial shareholder. I wonder. It will be revealed in the annual report soon enough.
Having staff work 24 hour shifts is not productive or something any manager should be proud of.
My final gripe is that another opportunity to present the agreed reimbursement price to the market is missed. The market is clearly not fully informed and this is not confidential information and is freely available.
The advantage is you can still buy this company for 300 million with an approved fantastic product. The disadvantage is the company is learning everything the hard way.
I agree. Also re management. I will say, though, that my many years in this company has taught me that PW generally does very good deals. He has been excellent at raising money at a premium, he has kept a very low burn rate and dilution has been minimal.
The delay in Europe right now might be due to regulatory red tape in the various counties: Ethics approval, data collection approval etc. I do think Clinuvel might regret by now that they decided to go it alone without a partner. Simply, they are too inexperienced to do a roll out by themselves. But it's learning by doing and eventually they will get it right and, as you say, perhaps use that experience to roll out Scenesse in the US for EPP while partnering for Vitiligo.
As for communication: It's a total disaster.
There might be an undiscovered market for Natesto.
Is voting for Hillary Clinton a symptom of low testosterone? This Florida doctor says, yes. https://t.co/4aGAfkQqQq
— The Washington Post (@washingtonpost) October 6, 2016
Yes, I watched the documentaries and they were well done. PW actually said at an AGM that they made a difference getting the FDA's attention.
I too think the meeting later this month will be interesting. Hopefully, they will be able to submit the first part of the NDA around new year.
On another note: What do you make of the chair's talk about an upcoming partnership ? I've learned with this company, that if he mentions something about a an extension of the group in a news letter, something is already in the works. But what ?
The next quarters will only have one direction and that's up. Especially when Germany and other countries come online. I think this is a bad time for a buy out because we can get so much more in a year or two so that's not concerning me. But I do think that the upcoming ph3 for Vitiligo and perhaps also the distribution for EPP in the US post PDUFA (hopefully next summer) would do best with a partner.
Congrats to you and everyone else invested. I have no stake in this but I've been lurking for some years. Well done ! As for your next play I know what I would do - and am doing. Hope to see you there NR.
New blog post from the mother of JT.
I wish CNN would pick up the story.
http://porphyriafoundation.blogspot.com/2016/10/a-journey-to-successful-protection-with.html?m=1
Our son, JT von Seggern has Erythropoietic Protoporphyria, EPP. EPP negatively effects the liver, results in vitamin D deficiencies and causes excruciating pain – all from exposure to the sun. JT has experienced the painful effects of EPP since he was 2 years old. It took us 9 years of extensive research and numerous doctors’ visits, including a trip to Johns Hopkins to finally get a diagnosis for what was causing our child so much pain. While gaining a diagnosis was a huge relief, learning that there were no treatments and no cure for EPP quickly knocked the air out of our initial relief. Exactly how does one go about protecting their now 11 year old, sports loving son, from exposure to the sun?
Daunting.
Through the ensuing years, JT experienced frequent pain, swelling, scarring, missed school days, and numerous rounds of Prednisone to bring down the swelling caused from exposure to the sun. Flash forward to the spring, 2015. The years of dealing with EPP and the understandable anxiety that accompanies such a cruel disease started to really take a toll on JT. By the time we picked him up from college at the end of the spring semester, it was agonizingly apparent that this cycle could not continue.
In May, 2015, we asked Dr. Silverman, the doctor treating JT if there were any new developments in treating EPP. There were none in the U.S. but Dr. Silverman mentioned a promising drug containing afamelanotide. I indicated that I wanted JT on that drug and while Dr. Silverman was sympathetic to JT’s plight, he informed us that it would be next to impossible to get access to the drug for JT.
At that point, the mama bear in me went into full fight mode to protect. Through a miraculous array of previous untraveled avenues, a happenstance meeting in New York, calls to Australia, Italy the U.K. and finally a contact in Zurich.
12, 670 miles traveled
2 cab rides
2 Trams
1 hotel
1 hospital
1 implant
2-3 months of vital protection
JT received his first implant of Scenesse in Zurich, Switzerland on August 11, 2015.
The protection that JT received from this first implant of Scenesse was nothing short of miraculous and life changing. A whole new world has opened up for JT. He only missed one day of classes due to over exposure, his grades went up across the board, and he gained back his confidence and left anxiety in the dust of his shadow.
…a shadow that was made possible by the successful protection from Scenesse.
The journey to successful protection with Scenesse is not an easy one, but it is the only option available until the FDA accelerates approval for afamelanotide 16 mg.
As we pulled up to Dulles Airport for JT’s second
implant scheduled for January 12, 2016, a
beautiful rainbow greeted us and we knew we
continued to be on the right path.
JT was all smiles as we awaited our flight to Zurich
We arrived in Zurich at 7:55 am on Monday the 11th.
JT rested up and prepared himself mentally for the procedure.
The hospital is just up the hill from the Tram station and off we trekked to Pavillion F in the hospital where the implant would take place. We were MUCH better at navigating this adventure since we had done this during our first trip in August.
Tuesday morning we arose early, ate and walked a few blocks to the closest Tram station and took the #14 to Triemli Hospital
After we arrived at the
designated spot, we
waited for JT to be called
into the procedure room.
The numbing patch that Dr. Minder had given me in August to apply to JT’s side did not totally numb him so after cleaning his side with iodine, Dr. Minder gave him an injection to thoroughly numb the area.
JT was called into the procedure area where we met with Dr. Minder and her assistant. Dr. Minder went over the procedure and then she prepped JT for the implant.
Next up, the actual implant! After it was all done and JT was bandaged up, JT rested for a bit just to make sure he was fine to make the trek back to the hotel.
Knowing Scenesse was in his body and would soon be protecting him from the sun made even this rainy Tuesday one full of hope and promise. Singing in the rain was not out of the question! ?
We walked back to the #14 Tram for the 20-minute ride back to the stop near our hotel.
JT rested the rest of the day.
Dr. Minder, Rocco Falchetto and Jasmin Barman joined us for a send off dinner. Both Rocco Falchetto and Jasmin Barman are EPP patients as well and being successfully treated with Scenesse.
After a good nights rest, we left our hotel and boarded our flight back to Virginia.
12, 670 miles traveled
2 cab rides
2 Trams
1 hotel
1 hospital
1 implant
2-3 months of vital protection
12, 670 miles traveled
2 cab rides
2 Trams
1 hotel
1 hospital
1 implant
2-3 months of vital protection
JT’s confidence knowing he is protected from pain for another 2 months shows on his face!
My question is, why? Why must we as American citizens go to such lengths to provide successful, safe protection from the sun? Accelerated approval for Scenesee (afamelanotide 16mg) is needed NOW. No EPP patient should be needlessly suffering.
FDA, Approve Scenesse
All this will be repeated again on March 8 for JT’s 3rd implant of Scenesse.
The lengths to which one will go through to protect their child are incredible.
And no EPP patient should have to endure all of this to live a pain free, healthy life.
Purple Light at 1:01 PM
I've had Palatin on my watch list for years because I am heavily invested in another company that produces the only approved and marketed melanocortin agonist, Scenesse. So far I have to say that I'm not impressed with Palatin and when it comes to their MC1R trial it is a blatant violation of the other company's patents. It's still on my watch list because of the MC4R action but I wound never consider investing until after NDA approval. If that ever happens.
"Now" should be "not." What a difference a W makes
USS, $6.50 is indeed conservative. With the number of EPP patients expected to receive treatment within few months we should be at $10 now. At least. And Vitiligo is now part of the company valuation at all. I see a risk weighed value at at least $100 m right now but it seems that the market is not at all taking notice. If we start to get more new eyes on Clinuvel hopefully all this will lead to a broader epiphany.
Yes. But I want to see this level hold before I dream of further uptrend. No question this stick is undervalued even at $10 but the low volume is a semi-red flag IMO. I don't know what's going on these days.
I think Wolgen is only focusing on on-label. In an interview some years back he said that the 'clever' ones realize that this is where the money is, and that all talk of off label is counter productive. I agree. EPP + Vitiligo holds tremendous value. Add some label extensions and perhaps an out license or two to BP on other non dermatological indications and $200 is not pie in the sky. I think Wolgen's strategy is to make Clinuvel as valuable as possible focusing on high EPP pricing and subsequently Vitiligo. The joker IMO is wether try will take on a partner in the US for Vitiligo.
Spot on.
Now that you've been practicing your written German you can take it to the next level and watch this video:
http://mobil.stern.de/panorama/wissen/schattenspringer-krankheit---wenn-dich-die-sonne-von-innen-verbrennt-7050636.html
It's one of the heroes of Scenesse. Jasmin Barman. She is a scientist herself and works with Dr. Minder in Switzerland. In the video she explains how she was diagnosed with EPP, the struggles it has brought her and how big a relief it was to get Scenesse. But I needn't tell you. You can listen yourself
German analysis of Clinuvel's potential. Very well written and levelheaded. I still think, though, that the author sets the number of EPP patients far too low. I would also adjust the number of Vitiligo patient to reflect the 2-5 % prevalence in the US and the fact that Scenesse will target FP4-5. Still, the number of potential patients is a lot higher than what the author assumes. But I like his conservative approach and comprehensive analysis.
http://minussinus.de/clinuvel-unterbewertetes-pharmaunternehmen-startet-markteinfuehrung/
Loving this discussion. It beats watching "Suits"
I'm a long time Trimel / Acerus investor and not proud of it. Seriously in red in that one. Endo used to own the rights to Natesto but they bailed out and Acerus made a deal with Aytu. I am hopeful they will promote the heck out of Natesto as I actually think it is a great product.
Some years ago I was very pleased with Acerus' management but today I see that they are incompetent. Just look at the share price. Aytu is our last hope but I have little confidence in such a small and unproven company. Hopefully I am wrong.