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ShareCafe is still there but only a few posters are still there. Everybody moved to the new forum.
I check in once in a while to see what’s going on and I’m feeling sad that so many obviously skilled individuals are being conned by an endless flow of fluff from the CEO.
The new go to forum for all things Clinuvel is www.sharetease.com
Register here: www.investclinuvel.com
Not trying to knock down anything. Not buying either. If I make back a little bit on the few shares I didn’t sell for tax loss write off I’ll consider it solace after the monumental mistake of investing in CRIX more than 7 years ago. Good luck, though. And I mean it.
Public service
Indeed. I believe the fluff some years ago and it cost me a small fortune. Could it be the real thing this time ? Sure. But my bet is no.
So, it just so happens that the researcher who gets the grant is working at same university that houses one of the only 13 RBLs in the country ?
And the timing of the PRs correlate perfectly.
Tell me the man who is capable of the “Mr. President, we’re ready” PR ... isn’t capable of such a stunt.
I would be extremely cautious with this one.
The company has a history with touting big news that is in fact fluff.
In this case, the company claims that a U.S. Regional Biocontainment Laboratory is testing Brilacidin. It seems to be correct, but the scientist who performs the testing is doing so only because of a $35k grant from the company:
https://www.google.dk/amp/s/www.news-medical.net/amp/news/20200605/George-Mason-researcher-examining-the-use-of-Brilacidin-for-treatment-of-coronavirus-infections.aspx
https://www.niaid.nih.gov/research/george-mason-regional-biocontainment-lab
https://stockdaymedia.com/innovation-pharmaceuticals-brilacidin-inhibits-sars-cov-2-covid-19-by-97-percent-in-a-human-lung-cell-line/
They’ve stated that it can take up to 12 months to be up and running. I doubt it will take that long since some insurance companies are already paying for patients to fly to Europe for treatment. And the price for 4-6 implants is actually quite low so they will probably not have no negotiate that much.
No, you do get quarterly reports. And lots of news will come out over the next 6 months IMO. Now they have the incentives lined up they will hopefully deliver.
And some thoughts about Vitiligo:
Prevalence is app. 50 m. world wide.
Let’s assume that the price per implant drops significantly. Let’s use $2000 and 4 required implants in the combination therapy that’s $8000 per patient.
With app. 3.200.000 Vitiligo sufferers in the US let’s say that 5 % in total (mainly FP IV & V) would want to use Scenesse in combination with narrowband UVB.
Let’s assume half of that target population can actually pay for the treatment.
That’s 80,000 patients yearly and $640,000 m. in revenues.
After taxes and expenses we would have have app. $450 m. and using a 25 P/E (because at that
stage we’d still be a growth company with other indications being developed) that’s
$11,2 bn. market cap and $229 pps. Use a very conservative 10 P/E and and the pps is $92 based on
Vitiligo alone. My numbers may be off but they do point in a direction and they could also be way too low.
Uptake could be slower but at a higher price. And this is US only.
Now, Vitiligo is also a way to get the lotions to market. A lot of “cured” Vitiligo patients will probably
require the Singaporean lotion Chivere of Tsumoyle as a maintenance therapy. That’s added revenues but
also a way to get the lotions out there and eventually to a broader market.
PW once talked about how he is inspired by Malcolm Gladwell’s book “The Tipping Poin” and
I believe Vitiligo would take us very close to exactly that. Once the price is lowered, we are treating patients
in the thousands, label extensions are sought and hopefully granted, the EPP core business is expanded
substantially in both EU, USA and Japan, off label is happening and lotions are about to hit the market,
then we are a totally different company and talking a pps in the hundreds.
EPP alone is much more interesting than I expected some years ago.
With the news efficacy data I don’t see why we shouldn’t be able to reach
2000 patients in fairly short time once we have both EU and US up and running.
Down the road that could double. 2000 patients x $15,000 per implant x 4,5
implants per patient (average) x 0,7 x 25 P/E / 49 m. s/o = $49 pps.
That’s for 2000 patients.
Many variables can change but the direction is up.
I posted this on ShareCafe and thought I’d share it here, too.
To reach 1500+ patients in the US, many will have to be diagnosed first.
There are app. 500 known EPP patients in the US today as far as I understand and I expect a swift uptake in most of
this population. Awareness will rise and more patients will probably be diagnosed over the coming years but I don’t think
we can expect 1000 patients right off the bat. However, I think 6 implants are likely in the US.
UK has app. 350 known EPP patients and if NICE surrenders I’m expecting around half of them to be
eligible for Scenesse during a managed access agreement unless the new PASS data gives us a better
QALY measure and full access. I think 3-4 implants will be maximum in rainy Britain.
My expectation is that we will reach 1000 patients treated in Europe soon.
NICE will have to accept the new efficacy data, and the Scandinavian countries
will follow. Denmark, Norway, Sweeden have app. EPP 100-150 eligible patients in total.
Germany will continue to grow and probably reach 500 patients treated soon.
Currently, only 4 patients are treated in Austria but the Ombudsman has requested
broader access so maybe we can get to 30-40 patients there, too. Switzerland and
Italy will also expand and The Netherlands are probably already maxed out. France is evaluating Scenesse for reimbursement as we speak. Spain could also
deliver 100+ patients. This is my short term base scenario for Europe. 1000+ patients at an average of
3 implants which results in US$45 m. revenues.
Add the 3-400 patients who I think we will be treating in the US within a year and we
have minimum 1300 patients of whom 300 will be getting up to 6 implants. Let’s assume the US patients will
be granted reimbursement for 5 implants in average and that’s US$ 22 m. per year short term.
So my most conservative estimate is US$ 67 m. in revenues short term which would result in
US$ 25 pps with a 25 multiple which I find reasonable.
After FDA approval Clinuvel is de-risked and the rest of the pipeline should also begin to
get some option value. Today, I don’t think Vitiligo, lotions, Enfance, XP or any
other aspect of Clinuvel than EPP in the EU or US is being given any value at all.
Australia and Japan as imminent targets for EPP should at least be given a risk weighed
value of something. Especially Japan is huge. When we are fully up and running in
Australia and Japan my EPP numbers double !
And if we move into one or two phase 3 trials for Vitiligo, the market will have to
begin seeing some value here, too. Vitiligo could be an enormous for the company and
even with 20 % risk weighted value being ascribed to Vitiligo today that ought to
add US$ 200 m. to our market cap. Imagine if we were a pre approval company with ONLY
Vitiligo but good results in Phase 2 and now moving into Phase 3. Such a company
could easily be trading at a market cap of 200 m. We have FDA approval for the drug
now so Vitiligo expectations has to begin adding some value, soon. And then there is the
rest of the pipeline.
My best estimate of fair value today is US$ 35 pps. which corresponds with
Sphene and Moelis’ 12 month targets of AU$ 50-58.
If all stars align and we get a move on, I think US$ 100 pps. is
possible within 2-3 years. When I dream, I see the company being acquired
at that stage at a 100 % premium which would give me an easy exit at US$ 200.
Wow. Just wow
Congrats all. What a journey this has been.
Now we can move on to another decade of strong growth. This is the Apple of life science and we are all very lucky to be here.
Big day. GLTA. Especially all the EPP sufferers who have waited their whole lives for this.
We have the potential for an epic short squeeze come Tuesday. Will be interesting to see how the stock behaves.
From a recently published PhD thesis:
Clinuvel
In some ways, Clinuvel succeeded against the odds. Its initial focus was on a drug to promote artificial tanning. It was thwarted in that plan, but was able to pivot and refocus the drug on a niche drug therapeutic indication, called EPP. By 2014, this provided a pathway to an approval in Europe, yielding some early revenues through limited distribution to a handful of European treatment centres. Even with limited sales, because the drug sells for between €56,000-84,600 per treatment course, it was able to generate $46 million in sales in 2018 and is projected to generate $133 million in 2019, based on a recent analyst report11. This continued sales growth, combined with the possibility of FDA approval in the US during 2019, puts Clinuvel in a strong position for future success.
Clinuvel’s drug, afamelanotide (Scenesse), is one of the few Australian-developed drugs ever to succeed in a Phase 3 trial, gain regulatory approval and generate sales. That alone is a mark of success. However, it is now also succeeding from an investor returns perspective. In September 2015, Clinuvel was trading under $3.00 per share. Three years later in September 2018, Clinuvel became the first Australian DDB to traverse $20 per share, breaking the $1 billion MV barrier. In a 2018 analyst report, it was predicted to reach a price of $31.70 per share in 2019, which would imply a valuation of $1.5 billion11. By April 2019, its market value was already approaching $1.2 billion and likely by the end of 2019, Clinuvel likely will be heralded as an unequivocal DDB success story.
Perhaps one of the reasons for Clinuvel’s success has been its leadership and culture. Dr Wolgen started as CEO in 2006 and implemented the strategic pivot that saw the company successfully pursue a niche therapeutic indication over the subsequent 10 years. In a 2009 ‘Open Briefing’ interview (Clinuvel ASX release, April 16, 2009), Dr Wolgen stated: “The key competency of my team is its resilience in professional adversities when encountered.” Finding ways to navigate
setbacks has certainly been a feature of Clinuvel over the years. In a recent article, Dr Wolgen reportedly described Clinuvel’s pathway to success as “tortuous”12:
“Rather than traversing along the fastest imaginable and plotted route to success, we have frequently been impelled to take tortuous avenues to achieve our objectives,” he told shareholders recently...Unlike the majority of ASX-listed drug plays, at least Clinuvel (ASX: CUV) has navigated these tortuous routes. It actually has a drug on market — to treat a rare skin intolerance to sunlight — which makes the company a rarity in itself.
The article went on to give Dr Wolgen much of the credit for the success of the firm. As an exercise, I calculated the IRR since 2006, when Dr Wolgen started; it was 10.6%. If Clinuvel achieves the projected $1.5 billion MV in 2019, that figure grows to 16%, which starts to approach a meritorious performance for a biotech firm.
In its 2015 annual report, Clinuvel declared the firm was making the transition to a ‘commercial’ firm. However, Clinuvel is still a DDB and far from being a commercial-stage DDC. Based on the 2016-2018 annual reports, it was evident that the focus was still on R&D, with commercialisation limited to generating a low volume of direct sales to 44 EPP ‘expert centres’ in Europe. Indeed, in its 2018 profit and loss statement, ‘business marketing & listing’, which was the only expense category that approximated commercialisation expenses, accounted for only 8% of the firm’s expenses, with the bulk of expenses associated with R&D and personnel.
Successful DDBs in the US have gone down the same path – using a niche market opportunity to generate early revenues to establish commercial proof-of-concept and make the product attractive to global commercial partners. While the EPP approval is a great regulatory breakthrough for Clinuvel and generates modest but useful sales, EPP is only one small indication for the drug. Its successful adoption by doctors for EPP will signal reduced risk as the company pursues much larger therapeutic opportunities in the future, such as vitiligo – the skin-whitening disease that affects up to 2% of the world’s population and is a significant unmet medical need in the US, especially among African Americans.
What Clinuvel is currently doing with EPP is effectively a pilot-commercialisation program that is logistically manageable for a small firm with limited real pharmaceutical commercialisation capability. Going forward, that capability may be tested, especially once FDA approval is obtained. Nevertheless, in the short-term, it has allowed the company to deliver to the sceptical Australian market a ‘commercial’ success story, even to the extent of posting a profit in 2018 and extracting a dividend to underscore the narrative. In terms of growing future shareholder value, it could be argued
that that dividend may have been better invested in more R&D to expand the future indications of the drug.
Over the next few years, as the indications grow for Scenesse, along with its potential launch in the US and the massive logistical challenge that represents, Clinuvel is going to need to rapidly expand its commercial capabilities. As noted in the 2018 analyst report: “Turning Clinuvel from a research driven company into a commercial global entity entails certain organizational risks, which could endanger the profitability of the company and therefore our price target”11.
The 2018 analyst report projected a dramatic growth in commercial costs from 2019, assuming a US approval. While it is feasible for a small Australian firm with no commercial experience or infrastructure to manage a handful of customers in Europe and without the help of a pharmaceutical partner or distributor, marketing in the US is a much more challenging proposition. Add to this, the potential expansion of the use of the drug beyond the extremely narrow condition of EPP to broader indications, and the challenge is amplified. As previously noted, infrastructure, management skills and culture are substantial barriers for a DDB seeking to migrate to a DDC. Life is much more complex at the commercial interface of the pharmaceutical industry and a large, multinational and highly-functional regulatory, logistical and marketing infrastructure is needed. Clinuvel may be able to make the transition to a DDC in the future, but to attempt it could represent a strategic ‘commercial focus’ error and might even threaten the survival of the firm. If it succeeds, it will take many years and Clinuvel would become a rare DDC transition success outside the US. More likely, Clinuvel will realise the capabilities challenge in front of it and seek a global licensing partner to manage international commercialisation. It may even choose to be acquired by that partner, monetising a multi-billion valuation for its shareholders.
Fortunately, Clinuvel has found a way to avoid the Red Queen, despite its aging patent portfolio. The original patent on afamelanotide expires in the early 2020s, which is theoretically an insufficient ‘runway’ to attract a pharmaceutical partner. Moreover, because the drug is a small-molecule, it does not have the Red Queen immunity enjoyed by biologic drugs (see section 10.1.6). So far, Clinuvel has circumvented this problem by selling the product itself for EPP in Europe, rather than relying on a pharmaceutical partner. It has also filed a number of follow-on patents covering specific uses of the drug and its specific drug delivery system. The other commercial protection it has is that afamelanotide is not a simple pill that can be easily copied, but a drug delivery device that is implanted under the skin and slowly releases drug over time.
On top of that, EPP is also commercially-protected by its ‘orphan drug’ status in Europe and the US. This is another measure to avoid the patent Red Queen. In order to stimulate pharmaceutical industry development of drugs for rare (orphan) diseases, the US FDA and the equivalent authority in Europe (EMA) introduced orphan drug legislation, which gives post-approval commercial protection for a
drug’s use in a specific ‘rare disease. In the US, the orphan drug exclusivity is for seven years after approval, while in Europe, it is 10 years. This confers a relatively weak form of Red Queen immunity, because it is limited to the first approved indication of the drug.
Again, Clinuvel’s other patents and its delivery system may provide adequate protection for the other indications, but once a drug is approved in the US and starts to generate substantial sales, patents are typically challenged by competitors and such challenges are encouraged and rewarded by the FDA. While competitors will probably avoid EPP, because it is a very limited indication and is protected by orphan drug exclusivity, they will almost certainly challenge the use patent for vitiligo and if that patent falls, Clinuvel’s long-term value proposition may fall.
Regardless of these challenges, the Clinuvel experience doubtless could provide some valuable lessons for other DDB firms. That would require a detailed case study analysis, which is beyond the scope of the current research. However, it would be a worthwhile future research project.
Unfortunately, the Clinuvel story cannot be held up as an example of successful Australian science, as afamelanotide was not the product of Australian research. It was licensed from the University of Arizona (Hadley and Dorr, 2006).
Yes, sorry - forgot the .au
It a great forum. I also recommend Google Groups:
https://groups.google.com/forum/m/?fromgroups#!forum/clinuvel
Welcome to the last week before PDUFA on Oct. 6th. Also welcome to new investors.
This forum has been quiet throughout the years, but perhaps it will be more lively with US approval.
If you seek information about Clinuvel and Scenesse, I suggest that you go to Sharecafe .com - or few free to ask questions here.
We are a lot of longs who have been invested for more than a decade and, personally, I intend to stay invested for years to come.
FDA approval only marks the beginning.
EPP in itself is very profitable. Lots of other indications are lined up and could be commercialized quickly. There is a cosmetic line about to be revealed.
Good luck to all. Old timers and new investors alike.
If you only look at the first indication, EPP, and estimate 4000 patients across Europe, USA, Australia and Japan (conservative total estimate) then we could be looking at $ 240 million in revenues and ~$50-60 pps at a 20 ratio.
Now, EPP might be financially interesting but in the medium to long run not that much.
Once the FDA has approved Scenesse, we will hopefully hear about Vitiligo ph3, cosmetics, Variegate Porphyria, Xeroderma Pigmentosum, a-Msh lotions and all the other things that we know for sure they have been working on for many years.
Probably a bit overvalued after the ASX200 run, then heavy shorting, FDA delayed 3 months and some nervous retailers perhaps.
I’ve never been more sure about this stock than now. Nothing has changed fundamentally and we’re still on track for FDA approval in less than a month.
The first indication is only a foot in the door but still very valuable. In a few years we will probably be NASDAQ listes and have several other indications online as well as the cosmetic line and a pediatric lotion for EPP. We are only approaching the starting line.
Eroding shareholder value.
I’ve followed this company for almost a decade and it’s classic Spana.
Congrats to those who made a quick 50 % and got out in time. I’ve been following this company on the sideline for 10+ years and never invested because I don’t like management.
I’ve been in CLVLY for 12+ years and FDA approval of Brem makes it even more likely that Scenesse will be approved in October.
Vyleesi is not a bad product and I do think it has a better future than Addyi. But there is only one company to invest in, if you’re interested in Melanocortins, and that’s Clinuvel.
Time for new ATH again. I wonder if Nasdaq listing is still on the table before August or if it’s postponed due to the FDA delay.
I’ve had Mereo on my watchlist for a couple of years and been doing DD on the pipeline. I’m especially excited about BPS-804 which could be a very needed and very profitable new drug if approved.
Management seems solid and heavy industry backing and the partnership with ICON is a big plus.
The stock seems oversold after the merger which obviously didn’t go well for OMED shareholders. Sorry about that.
It has provided me with a great entry point and I have now built a small starter position which I plan to enlarge significantly if the pipeline keeps maturing.
3-5 years this could be a x10+ stock.
Yes, good times. Not that I’m really surprised. But nice to see that we’re getting up there
I am so happy I cut my losses and walked away from this stock months ago. Too late - but better than spending more of my valuable time on this horror story.
If you’re new to this stock, do yourself the favor of going back and read the cascade of exaggerated PR’s from the CEO. I, myself, found it odd but stayed invested due to the science, which I found truly compelling.
As time went by, my dislike of the CEO’s style increased but I didn’t listen to my gut. It struck me that he acted increasingly as a used car salesman with too many big words and noting to show for it. He made himself and the company vulnerable to predators and, sure enough, the company was attacked. I blame it solely on the CEO
because he paved the way for the perpetrators and made it too easy for them.
I lost quite a lot of money but that’s what you have to live with when investing in biotech. Luckily, I’ve made a lot of money on the other solid companies I’m in, where I did act on my gut feeling.
Never again will I invest in a company where I find the CEO distrustful and shady even though his product seems compelling.
Back to enjoying life. Good luck if you choose to stick around.
Not really. A good friend of mine who is real sharp at TA did a model where we’d be at $14 in 2021 before going to +$30.
When you know all the catalysts that about to catapult this stock higher, such a TA model seems absurd.
What drives this stock is future earnings and they are massive.
$20 pps. for the first time. Good to see a slow and steady rise towards the levels we’ve been waiting for.
New company presentation for the upcoming road show prior to ASX200 inclusion and possible Nasdaq listing in Q2.
https://www.asx.com.au/asxpdf/20190304/pdf/443641yqv1b0fw.pdf
New analyst report from Sphene Capital:
http://www.more-ir.de/d/17623.pdf
Price target: 41,5 USD
Progressing nicely but still tremendously undervalued. 2019 will be an exciting year on all fronts.
IPIX Pharma LTD is hosted by Irish Formations and locates at North Point Business Park, New Mallow Rd., Co. Cork, T23 AT2P, Ireland
Irish Formations offers company formation packages for new companies in Ireland.
The two directors listed are Arthur Bertolino and Leo Ehrlich and the authorized capital is 1 million Euro.
I have zero trust in the CEO but since I’m down 97 % on this horrible investment I’m still holding just to see if a miracle occurs. Otherwise is my ticket fee to experience the continued IPIX Circus. It’s quite entertaining to be honest.
PDUFA date secured with priority review: July 8th. 2019.
This is a significant milestone and the fact that the FDA doesn't plan to hold an ADCOM meeting is both surprising and reassuring.
For new investors:
Clinuvel's lead compound, Scenesse, is already approved in Europe by the EMA. It's marketed in numerous EU countries and in high demand by patients. Great Britain (NICE) is reluctant to pay the price but everyone with knowledge about GB knows that the system is broken and that tary are trying to curb expences in any way possible. Clinuvel won an appeal, though, and I assume NICE will cave in March at the final meeting.
New indications are also underway. Vitiligo is headed to Phase 3, a POC in VP is underway in Europe and a 3rd indication will be announced soon.
The Company is also develloping new products. A cosmetic line that will probably be launched soon. It was due last year. And several lotions that are being develloped in Clinuvel's Singaporean lab, Vallaurix.
Moreover, a move to Nasdaq is planned in 2019.
This is a remarkable Company with no debt, loads of cash on hand, strong Growth, big institutional backing and loyal top 20 owners. A brilliant CEO with a vested interest. And soon: FDA approval wich will only be a foot in the door and the beginning of the real growth adventure.
GLTA
For those who hope for news regarding the FDA meeting: The FDA has 30 days to send out the minutes and in the interim, it’s foolish to issue any press release mentioning details about the meeting. The official minutes describes what’s was agreed upon and any outstanding issues or disagreements between the FDA and the sponsor. If the CEO issues a PR before having the official minutes he will be continuing the disastrous, naive and amateurish coms strategy.
Sorry if I’ve been unclear. I’ve never fully trusted him but I’ve chosen to do so nonetheless. I guess it’s like being pregnant. Either you are or you’re not. I should have listened to myself. But the science has always intrigued me and I chose to think it was just his “style” and didn’t follow my gut feeling. I’m so much in red it doesn’t make sense to sell so I regard my money as being lost. But I’d like to be proven wrong.
Karin, you have met Leo on several occasions if my memory serves me correct. I trust your assessment of character so I’d like to ask you how you view him now. I know you used to hold him in high regard but given the current state of the company, the missed milestones and how it was buried under a rug, the shady financing deal involving his son and all the other fluff PRs that IMO now stand out as particularly shady in the rear mirror, how do you see him now ?
Personally, I only blame myself. I’ve always had a bad feeling about his character but I gave him the benefit of the doubt and invested anyway. Now, I’ve come to the conclusion that he is an amateurish used car salesman not capable of running a company. I might even think he’s a fraud but I’d like to be proven wrong.
Look, no one is bidding. At all.
Leo is all about smoke and mirrors.
If someone wanted to partner with the company or if someone had the slightest interest in one of the assets, they would just buy the company for their lunch money at the current state it’s in.
If Leo had any faith in the P results (and some dignity) he would pay the CRO out of his own pocket. It’s not like his handsome salary doesn’t allow him to do so.
If you’re the CEO of a company that you believe in you do what it takes to bring it forward.
Instead, he is going through all sorts of loopholes to get more money from dubious sources and still hasn’t payed the CRO.
Not that I really care. I have written off my investment in this historic and epic failure. My own fault. I invested in a company led by a CEO I have never really trusted.