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.
What a night. Looking forward to US opening tomorrow.
The NDA is not yet submitted, it seems. But I will have to happen soon.
New products to be announced soon and increases awareness amongst investors in Germany seems to drive the sp up.
Yes, as expected but still very comforting.
Today will be another +4-5 % day.
If the company doesn’t confirm they submitted the NDA it will most likely fall back somewhat again until they do, but with PDUFA approaching we could easily double from here.
Either Clinuvel has now completed and submitted the NDA or we are very close.
I still have November / December as potential PDUFA if we get priority review.
The next days and weeks will be eventful:
1) The NDA will (probably) be submitted within the next week or two.
2) May 20th: Launch of skin care line
3) May 23rd: NICE decision on reimbursement in GB
4) H1: Norway’s reimbursement committee decides (if within normal timeframe)
The most reassuring thing the CEO can do today is to NOT issue a PR of any kind.
Post by ValueFox of SS:
Sphene Capital are indeed a very small and focused boutique, mainly providing IR-related services to small companies to increase awareness in the capital markets. In most of the cases, the companies are paying for the research reports - but in this case, the founder has initiated coverage on his own after discovering the company. I had a long conversation with him some weeks ago, also about the non-existing IR work and that they seem to refuse to allow contact with financial analysts to an extent where it appears to be an obsession. I guess that CUV is afraid of a large float ownership of retail investors who would happily trade in their shares at a 100% premium in a take-over offer - so they try to stay out of the spotlight of retail investor channels (that's the only way it makes sense to me in a rational manner).
I think while the reach of Sphene Capital is limited, I think we can try to multiply on it and help spread the word. I believe that this in-depth compilation is very unusual for an analyst report (because of its superior quality and research effort=, and at least for me creates far more reassurance than the back-of-the-envelope "research" we saw from Florian Homm.
Analyst coverage of Clinuvel.
Price target 12 months: AUD 31.70
http://www.more-ir.de/d/16065.pdf
Have been following Palatin for some years now but have never bought.
I’m heavily invested in another Australian company with the only approved and marketed melanocortin product out there.
Palatin might have a chance getting the MC4R drug through FDA. In that case I will buy but not until approval of the NDA.
Until then there is only one credible player in this field.
GLTA
Stan did mention a “hand over.” So I think it’s reasonable to assume that PW will head the company for 3 more years and then be gone.
I don’t agree with everything he does nor the huge salary. But I think he’s doing a pretty good job all in all.
Patient retention isn’t an issue if you look at the company’s numbers.
Seasonal differences and when the goods are actually paid for has an impact. If the clinics stock up or order close to next quarter and pay later it will cause a spill over to the next quarter.
PW is resigning in 2021 at the latest. I think he is motivated to move fast in the US once we have FDA approval. Until then, they will duck and stay under the radar.
I think it’s a mix of several things.
Perhaps a mini pre-NDA filing run up.
In Germany Florian Homm is actively promoting the stock.
And then the chair’s newsletter yesterday:
Whilst the Board of CLINUVEL looks back on a very successful 2017 it must now look forward to exciting times ahead. The Group will engage in many activities on several continents, and we are expecting to see the first fruits of internal research coming to the public eye.
Insurers and payors worldwide continue to restrict availability of reimbursements to patients needing “orphan drugs”. Nonetheless, as a counter-measure, we continue to broadcast the clinical successes achieved in the countries that do offer financial support for erythropoietic protoporphyria (EPP) patients1 in recognition of SCENESSE® (afamelanotide 16mg) as a treatment.
The long-awaited highlight for 2018 will be the final submission to the US Food and Drug Administration (FDA) of what has been a challenging SCENESSE® dossier as part of the new drug application (NDA). Activating pigmentation by way of a hormonal therapy in light-deprived patients – EPP – has proven a difficult task for even the most experienced scientific regulators and consultants. However, as the European and Swiss patients have shown, our concept is not only effective but also of long-term benefit, it is hoped that the FDA will not wish for North American patients to be excluded.
CLINUVEL’s clinical and regulatory team have adopted a strategy of full and open communication with regulatory bodies, and the FDA has signalled receptiveness by having first accepted the clinical data for submission, then waived carcinogenicity studies, granted Fast Track Designation, and organised three meetings with relevant patients and experts while the formal scientific review is yet to be concluded. This persistent approach taken by our management team has brought us to where we are today as a company. Those that operate in our industry will have insight as to when the theoretical diverges from what is practical and optimal and so will better understand and support the decision pathways of CLINUVEL. It has not gone amiss that the Company’s application to the FDA is to be submitted during these politically and economically sensitive times, and we continue to take technical and substantive measures to best position the Company’s application.
2018 will be my last full year as Chair of CLINUVEL and I would certainly prefer to exit my role as Chair with the knowledge that shareholders, active investors and the domestic business community view CLINUVEL as a successful Australian pharmaceutical entity, and one of the few to have withstood the test of time while taking a New Molecular Entity from concept to patients in two major global markets.
It is essential that CLINUVEL is positioned to ensure that continuity and stability of success are guaranteed long-term. Having worked with previous executive teams, and certainly at CSL one led by one of Australia’s greatest CEOs, I have come to appreciate up close the efforts and accomplishments of our current CLINUVEL management against significant odds and challenges. In golfing parlance they are certainly besting par on the biotechnology course.
As Chair of the Board I have led and participated in intense deliberation on the positioning and vision for the future of the Company to ensure they are consistent with the interests of our stakeholders. All knowledgeable consultants and key investors in our industry have made it clear that continuity under current management is preferred and mandatory for us to reach our long-term objectives. As a Board we are privy to key management decisions, and it has become obvious to us, and those with a standing in the sector, that Dr Wolgen’s intelligence, vision and forthright manner will succeed where others may well have walked away. This approach has taken CLINUVEL to the success it enjoys today.
At this critical point in time the Board considered it absolutely essential to persuade our Managing Director to sign one final employment agreement to prepare the Company for a handover by 2021. With Dr Wolgen’s commitment to guide CLINUVEL through the next three years, as Chair I believe it secures the interests of those stakeholders who have provided funding for our programmes over the past several years.
Together with the retention of the Managing Director’s services and the need to retain key personnel and have a succession plan in place for senior staff, the Company has put in place a Professional Development Program for senior managers. As part of that program Dr Emilie Rodenburger will be assisted and guided by our Acting CSO Dr Dennis Wright to become the Company’s next Chief Scientific Officer.
CLINUVEL will attract a wider audience in 2018, not the least by diversifying its product offerings to new markets. The knowledge gained as a specialty pharmaceutical company, and the confidence gained among the top academic experts worldwide, will need to be translated into a continuum benefiting a wider market. CLINUVEL will launch its premiere non-pharmaceutical product lines under private label. These dermatological products will be complementary to SCENESSE®. Fitting our 2018 strategy, CLINUVEL will exhibit its first conference display in Asia and Europe, our main targeted markets. This will be discussed by our Managing Director in more detail over coming months.
For the next twelve months Management and Board will give its best to achieve our objectives, and it gives me a sense of great pride and humility to have served as Chair over the past years. May we all look forward to an exciting 2018.
Many European countries look to NICE when establishing a price for reimbursement. So I do appreciate why Clinuvel went after NICE first. And I don’t think the battle is lost yet. Germany went through arbitration and I think NICE coukd eventually go through a similar process.
I lean towards your second scenario. They probably offered the EMA data hoping that real life data would make up for trial data (that was not representative because of the difficulties getting patients to expose themselves to sunlight). Because of the extremely slow rollout partly due to the NICE fcukup they didn’t have enough patients online to offer the FDA sufficient data. I’m not really concerned about FDA approval. If I were, I would reduce my holding and I’m not. What I’m not happy about is the fact that they don’t have a professional PR person.
I’m not expecting any bad news. Only possible delays before good news.
I don’t think there is much risk the FDA will reject the NDA. The patients meeting, acceptance of the data package and the carcinogenic waiver bodes well. The FDA wants to approve but needs more solid proof of efficacy to do so. The EMA post approval data will be the last piece in the puzzle and I expect Clinuvel will be finished analyzing by February.
My expectation is that they will file the full NDA in April, 2018. 2 months of validation and the formal review can begin by July, 2018. That brings is to H1 2019 for possible PDUFA.
In the meantime look out for possible NICE approval (reimbursement) in GB and new European countries online.
The company is notoriously misleading the market with unrealistic timelines and delays. But the risk of failure is very limited IMO. It’s just a matter of time.
CUV.AX is the Australian listing. Because it’s difficult and / or expensive for US investors to buy there we have the ADR option though CLVLY or CLVLF. Today, the only difference between the two ADRs is that CLVLF gives you voting rights.
In Germany, Clinuvel is listed as UR9.
Someday, Clinuvel might choose to uplist to one of the major exchanges here in the US but it will probably be a while.
I can't say that I'm very happy after the AGM. I had expected that management would deliver on all or at least some of the promissed updates both Philippe Wolgen and Stan McLiesh have touted on numerous ocations. The CEO wrote this in July, 2017:
"In the coming months, a number of publications will centre on the restructuring and repositioning of CLINUVEL, illustrating how we aim to take the Group to gradual growth while providing more visibility in US, ASEAN countries, and the EU."
Management made investors believe that a "restucturing" of the group was imminent and that there would be an enhanced focus on the US market. Possibly even a strengthened presence / new office.
None of this materialized and investors were again left hanging. Hence the sell off.
The fact that the NDA is again delayed doesn't bother me much. That's just bio. What bothers me a lot is the blatant disrespect for investors and the amateurish PR by Lachlan Hay. The CEO told investors that the NDA would be finished by summer, 2017. When July had passed and nothing happened, Lachlan hay gave an interview to an online media (behind a pay wall) where he stated:
"… we like to be aggressive in our targets. Certainly by the end of this year."
Now, we know that February 2017 is the earliest possible and more likely April or May.
Clinuvel is playing investors for fools when it comes to timelines and promisses made in PRs. What the heck ever happened to that restrucuting they where going to tell us about "in the coming weeks" ?!?
That said, I still think 2018 will be a good year. Clearly, Clinuvel is not a very professional entity (just look at the fact that Philippe Wolgen is negotiating in German - I think ICON would have staffers ready to hire for that task) but they seem to have the eye on the target nonetheless. At some point the European roll out will get up to speed, and if they manage to lodge the NDA dossier in the US in H1 that will make a splash.
I have no faith in the OTC products they are now promissing to launch in Asia next year. Perhaps in 3 years. But organic EPP growth, hopefully NICE approval in H1 (unless they let a non English speaking person do the negotiating) and a finished NDA in H1 could get us past $10.
My wish for 2018 is that Stan McLiesh is replaced with a younger, more vital and more straightforward person. Also, I wish that Lachlan hay is made permanent office manager in GB and that media and PR will go to a real professional. Clinuvel will be crushed in the US (if they ever list there) with the current level of misinformation.
Still loving the product.
Clinuvel AGM begins tonight 6 PM EST down under. GLTA
Updated. Feel free to suggest changes and additions.
Yes I am. Will work on it soon. Thanks. And welcome
I’m not too worried about a CRL. With rolling review and the data package already being accepted it seems like management is actually trying to get it right this time and that the FDA is is generally positive. No doubt Clinuvel are amateurs. But I do believe they are learning on the job.
I’m eagerly awaiting answers to:
1) What is the US strategy?
2) What will the US price be per implant ?
3) Will NICE reimburse ?
4) New EU countries online soon ?
Ghmm, have you ever heard about priority review being sought and granted prior to the formal lodging of the NDA ? I haven’t.
In the AR PW wrote that they asked for priority review “earlier this year” so IMO we are looking at mid December for granting or rejection of the dossier.
Good post.
I agree on all counts. The uniform pricing is causing many delays and it would be much wiser to negotiate unilaterally and get the ball rolling.
Homm might be spot on in his valuation of Clinuvel but he is also a (former) criminal. He was behind ACM when it invested heavily in Clinuvel and IMO caused the 2007 all time high. Old timers like me also remember the painful dump right thereafter.
The good thing this time is that we are undervalued and that he is right. I’m just concerned that the volume suddenly picks up they way we’re witnessing. Who’s selling ? Lagoda ? I don’t think so. Is it orchestrated and who is helping Homm ?
I’m a bit worried that Florian Homm is behind the the sudden huge volume but at least we are approaching fair value.
From SS - Investek
So where will the US base be located?
Annual report covers indicate a shift from East Coast (2012) to West Coast (2016)
San Francisco Bay Area?
Top 10 U.S. Biopharma Clusters
http://www.genengnews.com/the-lists/top-10...usters/77900917
Current - PO BOX 7388, Menlo Park, CA, 94026
Connections/Potential Rational - (VC, Silicon Valley, Stanford, Ender 1 LLC, SNP Ventures, Sean Parker, $, IPO, valuation)
http://clinuvel.com/clinuvel/contact
https://techcrunch.com/2017/01/06/this-mill...he-pull-it-off/
Current - US Office. 40 Worth St, 10th Floor. New York, NY 10013
http://www.clinuvel.com/investors-contact
http://www.porphyries-patients.org/uploads...PPCommunity.PDF
2011 - Ted Agne?The Communications Strategy Group Inc. Boston, Massachusetts, USA
?http://clinuvel.com/2011-announcements/item/download/4_876dc64100e0dee365e65f6d6c7601c8
2010 - A satellite office has been established in New Jersey to coordinate all US activities.
(Valeant?)
http://clinuvel.com/2010-announcements/ite...b0efe7e3f76dd28
2009 - Suite 560, 353 Sacramento St, San Francisco, CA 94111
http://www.asx.com.au/asxpdf/20090226/pdf/31g92jzh20ckdw.PDF
Attached thumbnail(s)
Reduced 55%
Attached Image
750 x 1334 (308.97K)
Reduced 55%
Attached Image
750 x 1334 (364.94K)
Pretty dramatic effect of Scenesse.
http://fb.me/8n8owyMze
Upcoming catalysts:
News about US listing and / or presence.
Final NDA module lodged
Priority review in the US
Chivere / OTC progress
Scenesse Enfance
More European countries online
NICE (first meeting November 2017)
4C out
http://www.asx.com.au/asxpdf/20170731/pdf/43l021w2gbhj0d.pdf
$6.247.000in receipts vs $1.235.000 last 2nd quarter.
$23m in the bank. Impressive.
Overall very good given the fact that last quarter ought to be off season. Next quarter will be even better.
With cash on hand and the current results we ought to be at minimum $10 per share today. Also add NDA approval within the next year or so and further roll out in Europe.
Their communication sucks and they are very much behind schedule but the product is a winner.
Comments from the reputable poster, Frogster of SS (copy / pasted):
In Reply To: ajshare's post @ Yesterday, 07:30 PM
Happy to see those numbers. They're great versus my expectations. After the disappointment of the previous quarter I was only looking at A$4m receipts. Happy to be wrong this time.
Couple of comments from other lines items:
-Cash generation was strong on these receipts, helped by corporate costs nearly A$0.4m below guidance - my guess is this might be an exchange rate effect (more on this in a minute) - and also by production costs being also nearly A$0.4m below guidance. Even if these items weren't flattering, I'd be pleased to see the cash generation. It's still better than I thought it'd be.
-After a few quarters of very low R&D spend, the current quarter will be ramped up a little again to A$0.15m. Scenesse Enfance/Goat thing spending ramping up? They also spent nearly 4 times more in the reported quarter than predicted (prediction was only A$0.02m).
-Production costs for the current quarter are expected to be A$0.7m. I find it a little tricky to interpret this. They were expecting A$1m for the quarter just reported, and it was only A$0.6m. Does this mean they are already stocked up for peak seasonal demand? Does it mean peak demand is going to weaker than previously thought? Does it mean they're just getting better at forecasting this cost (they've been way off a number of times now). Time will tell, but my guess is a combination of these 3 factors.
-I wouldn't be surprised if we see a corrected version of this 4C published. Item 4 in it seems to have arithmetic/presentation errors. Item 4.2 suggests A$4.626m was USED in operating activities rather than was GENERATED by it, and Item 4.5 suggests exchange rate movements consumed A$0.375 rather than inflating balances as suggested by the difference listed at year end (28) versus that at the 9m stage (403). If they have listed the sense of these movements correctly, then the cash at the end of period should be 18772-4626-21-375=13750. Given they have a bank balance of A$14.339m this cannot be right and must simply be an error!
This is sad. Enough. Arrest this Mako bastard.
Solid CC with lots of good info. Just as I expected the stock is tanking today. The name change and one single professional investor cc doesn't change anything and the artist formerly known as CTIX will be haunted by the sins committed over the past years until there is a partnership.
I know, Karin. I've been here for more than 12 years so trust me, I know But I still think Clinuvel is on the verge of actually making huge gains. EMA approval was the beginning. Sales in Europe. Then FDA approval within the next year. They are much further along than the other one we also bet on. Very limited downside. Huge upside. But as always - and as you so rightly point out - time, patience and still a good portion of luck is needed.
Compared to the extreme long wait many of us have endured I think this year could be a lot more eventful and prosperous. Clearly, FDA approval will be a big thing and while sales in Europe is progressing slower than most like the patient demand is huge and eventually they will get the implant. What's another few months when we have been here for so many years ? And again, FDA approval is a lock IMO so 12 months from now I expect at least a double in pps.
Upcoming catalysts for Clinuvel:
I expect the filing of the rolling NDA to be finished by July. Perhaps even before but don't count on it.
Then we will most likely get a PR stating that the FDA has granted priority review and that a PDUFA goal date is set in Q1 2018. My bet is February 28th but it's just a guess.
Approval is a lock IMO. And fairly quickly distribution will begin through the expert centers and sales will ramp up.
Meanwhile, in Europe, I expect more counties to come online this year as the price has now been settled with the German AMNOG.
The next quarterly coming out tomorrow will most likely be modest as most sales could have occurred late in the quarter and the money not actually been payed yet.
But Clinuvel continues the steady progress and I think we will see tremendous organic growth over the next year.
No. Many applauded the hiring of Dr. B - my self included - because he brought some long needed experience to the company. I hoped he would be taking over from the CEO as the face of the company and also put and end to the amateurish PR strategy. He might be in the center when it comes to the science but the CEO is still clowning around when it comes to communication. I would be upset if I were Dr. B. right now.
I was hoping that Dr. B. and the good people he brought with him would professionalize the company and provide the CEO with some grown up assistance. I wonder how they feel about their new work place right now. If I were a person with Dr. B's experience I would feel quite deceived right now. I hope he can talk some sense into the CEO.
Hallelujah. A first year PR student would know that hyping a conference call one week only to deliver a presentation the next would result in this.
Which proves that the CEO is a complete amateur when it comes to PR. After years of fluff and being punished for it he should have used the opportunity of letting Dr. B. do all the communication. You simply can't communicate A and deliver B or C. You have to be as accurate as a surgeon when you choose your words as a CEO. Had the CEO been a surgeon the patient would be dead by now.
If this company survives, It's my hope that the CEO will step aside, remain a majority shareholder and let Dr. B. run the show.
I suppose you could be right but I've never really believed the manipulation theories. Perhaps my imagination isn't good enough. There is a strong de-connect between the science and the pps that's for sure and that's why I'm still here.