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Frogster
Posted on: Jul 7 2020, 02:17 PM


Group: Member
Posts: 692

Billy, here's some reading for you. I hope you find it helpful.

https://asic.gov.au/for-business/running-a-...any-securities/
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Frogster
Posted on: Jun 30 2020, 12:23 PM


Group: Member
Posts: 692

So if this is an opportunity to reset or refresh thoughts, I'd say the following:

I think PW and the Board developed what has proven in the broad to be a very smart approval strategy.

I admire many of their achievements and have said such on here and in attempted direct communication.

I think their collective tenacity has probably been their strongest asset, and in the most this has overcome missteps potentially made through inexperience.

The strict cost control which arguably has limited the rate of corporate development has also been the reason we've experienced only small amounts of dilution. The jury is out on whether this was the right approach. If the company can expand products and stay ahead of the competition in the next 10 years, the answer will be yes. If we get swallowed up by others in that time frame the answer will be no.

What has been most frustrating to me over the long term has been the sometimes seemingly disingenuous way the company has communicated it's activities which seems to always suggest the delays/errors/problems have been someone else's responsibility (supplier problems in the case of topicals, still awaiting ethics approvals for the VP trial and the storied 3rd indication, FDA have asked for more detail rather than a major omission existing in the original NDA, etc. etc.). If the delays in trails and launches are actually due to internal cash flow restraints (which to me appears more likely) I'd rather be told that up front. I certainly do not expect the company to tell us every minute detail of what and why, but neither do I expect them to pretend everything has proceeded perfectly as planned when it clearly hasn't.

A little honest external scrutiny might be good for them. Recently PW was quoted by Bloomberg saying that the lack of research on them was probably the reason for the large pile of shorts out there, and yet they pursue a policy of not talking to analysts which perpetuates the lack of research (Sphene recently told me they've dropped coverage due to the lack of responsiveness to their questions).

I think a few minor changes in the way they interface with the outside world would lead to a radical change in the way they are perceived by it, whilst also lessening the information vacuum we perceive and attempt to fill.

Regarding discussion of the company, I'm all for places where a civil, balanced and respectful exchange of ideas can take place. If the discussion is genuine and positive, great. If it's genuine and negative, well, not great, but it should occur.

I'm hoping CUV has a bright future with significant further upside. Whilst I have some frustrations with the way they go about some things, I intend to hold till more of that upside is realised.
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Frogster
Posted on: Jun 23 2020, 07:11 PM


Group: Member
Posts: 692

That's great news, but why has Palo Alto disappeared from the map?
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Frogster
Posted on: Jun 23 2020, 12:19 PM


Group: Member
Posts: 692

Not as stubborn as us longs.
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Frogster
Posted on: Jun 21 2020, 09:20 AM


Group: Member
Posts: 692

Royco, with genuine respect for such a long-term contributor to this forum, I agree there is tremendous value found here-within, but I'm obliged to say I think your suggestion that CUV should buy ShareCafe or sponsor posters in some way is bat-shit crazy - it would kill all of value on here.

Some content from here populates the horizon with speculative yet plausible future therapeutic targets via technical research papers.
Some content helps identify medium term strategy via patent updates, domain registration tracking and trade mark notifications.
Some content updates us with near real time monitoring of current fundamentals via close scrutiny of reimbursement lists, national payors and regulatory listings.
Some content helps provide a critical scrutiny which corporate policies preclude from taking place in other mediums.

Much of this information is undoubtedly positive for the company, but it would not be prudent to even tacitly approve it by having it published on an owned channel. A portion of this information is unhelpful to management as it, from time to time, counteracts the narrative they would rather present and they would be happier if it didn't see the light of day.

Clinuvel has a strong dislike of being discussed so thoroughly on here. They like to control information very, very tightly and we, collectively, inhibit that. Remember in just the last few weeks their head of global operations accused some forum posters of illegally sharing content from social media and, presumably, was the catalyst for having several post moderated on this site. Furthermore, on several occasions comments have been directly made in person at AGMs by senior management criticising in the strongest terms our valuable information/opinion sharing platform.

In my view, CUV would be the worst possible steward of this forum (but I agree with the sentiment of the rest of your post).
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Frogster
Posted on: Jun 9 2020, 12:57 PM


Group: Member
Posts: 692

I wonder how onerous the follow up commitments are on the specialist centres. My guess is that any hesitancy in establishing new ones is less to do with the procedure itself, and all to do with the legal hoops and agreements around distribution and ongoing care commitments.
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Frogster
Posted on: Jun 5 2020, 05:56 PM


Group: Member
Posts: 692

Another decent (60,000) share trade in the after market today.
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Frogster
Posted on: Jun 5 2020, 10:52 AM


Group: Member
Posts: 692

2 major changes that I've noticed:


1) Global "Uniform" pricing policy:
Text from UBS conference, 18-20 May, p10:
"Reflecting our corporate values of fairness and equity, CLINUVEL's price of SCENESSE is uniform across the countries we supply. We have priced the drug at the lower end of the price spectrum for orphan drugs. The retail price of pharmaceutical drugs has received significant social and political focus, particularly in the USA. CLINUVEL's approach fits well with clear societal pricing preferences in the USA."

The slide itself refers to Clinuvel Global Net Uniform Price.

Text from Jefferies slides, today, p9, the above text was substituted for the following:
"CLINUVEL is conscious of its pricing policy and has taken a different approach than most pharmaceutical companies. Retail price of pharmaceutical drugs has received significant social and political focus, particularly in the USA. CLINUVEL's approach fits well with clear societal pricing preferences in the USA."

Note NO verbal reference to uniform pricing, or fairness or equity, but the slide itself STILL refers to Clinuvel Global Net Uniform Price

So, Clinuvel, what is your pricing policy? Have you dropped the global uniform price, or are you still pursuing it? Maybe you just forgot to adjust the slide for the Jefferies conference? My guess, especially in light of the evidence we've found for differential pricing, is the latter. PW has made much of the global uniform pricing policy and how much the regulators and insurers love it. How embarrassing is this change, and how wonderful of him to let IR disseminate the news? It might be good for the financials, but yet again the consistency and credibility of management ticks down a notch, and CUV comms can't even be consistent in where it moves the goal posts to.

I guess finally dropping the uniform policy opens the door for European pricing flexibility, which might underpin "working on on reimbursement agreements to distribute SCENESSE for EPP in more European countries". Maybe the strategies of all those other experienced pharma companies wasn't so dumb after all?



2) Additional comments re pediatric version:

Developing a pediatric formulation of SCENESSE . To date, afamelanotide has not been evaluated in individuals under the
age of 18. A pediatric dose of afamelanotide is under development by CLINUVEL's R&D laboratory, VALLAURIX. Drug
development for pediatric populations requires a dedicated approach, including:

Putting the safety of pediatric patients first, including evaluating whether there are unique safety concerns for a
pediatric population or age ranges within that population (for example adolescents or infants);

Ensuring there are sufficient data to justify the use of a drug previously untested in pediatric patients, including
data from use of the drug in adults and pre clinical model studies;

Developing pediatric specific formulations , where appropriate, and conducting definitive pediatric pharmacokinetic
studies to arrive at appropriate doses (generally the adult and pediatric dose will differ); and

Establishing study designs which recognise that the safety profile of a drug and the clinical impact of a disorder may
differ between pediatric and adult patients , as well as across pediatric patient age ranges (this is particularly
relevant for long term safety monitoring as pediatric patients mature, such as during CNS development in toddlers
or sexual maturation in adolescents).
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Frogster
Posted on: Jun 2 2020, 01:49 PM


Group: Member
Posts: 692

He's an accurate worker and good at explaining things? They should get him to do all the regulatory submissions and investor communications, CEO and chair letters included!!!

More importantly, however, is that a 6th US EPP treatment centre has popped up on the treatment centre map in Palo Alto, CA
https://scenesse.com/public/epp-centers/

I can't (yet) find exactly who is running the centre, but that seems like a pretty good place to be getting some attention. It's be great to see a couple of East coast centres next.
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Frogster
Posted on: May 28 2020, 04:27 PM


Group: Member
Posts: 692

Remember what is due on 31/7 is a 4C Cash Flow statement, and that will cover cash flows to 30/6.
There is zero obligation to report sales revenues in that document. They have been getting a bit better in offering more info than is strictly required in a 4C of late, so perhaps they'll give USA commentary referring to sales, but I doubt they'll be very precise on numbers.

The next report to show revenues will be the 4E Full Year results due on 31/8.

We know US injections started around mid April. Therefore US revenues should be recognised from around that time (probably a little in advance of it). Associated cash flow might not be seen for 30-60 days depending on payment terms as we've discussed before. So, my guess is we'll see a little US cash flow in the 31/7 4C, but not a whole lot and it will not be the same quantum of the sales of the same period.
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Frogster
Posted on: May 23 2020, 09:38 PM


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Posts: 692

So, maybe 6m recruitment phase (maybe longer?) 12m study, 6m analysis? 2 years till conclusion of trial? Only then would an application be considered. Scenesse is unavailable if you are involved in other studies, which will limit those willing and able to participate. Whilst it still appears to be a threat, there seems to be a good window for Scenesse to get established and for CUV to diversify.

I'd hope CUV is working pretty hard to gets centres opened in Columbus and Boston ASAP.
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Frogster
Posted on: May 23 2020, 09:20 PM


Group: Member
Posts: 692

MT 7117 still bubbling away. Posted on APF website on Friday:


https://porphyriafoundation.org/news-blog/a...t-sites-active/


Text from the Apf website:


Announcing a Phase Three Clinical Trial for EPP Participants with EPP / XLP are Needed! FIRST SITES ACTIVE
Friday, May 22, 2020
We have exciting news that Mitsubishi Tanabe is announcing a Phase 3 trial for MT-7117 for people with EPP.

Trial Description: A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy, Safety, And Tolerability of MT-7117 in Subjects with Erythropoietic Protoporphyria (EPP) or X-Linked Protoporphyria (XLP)

Treatment: Oral medication (pills), once daily in the morning with or without food Duration: 26 weeks plus optional 26 week double-blinded extension.

Endpoint: Increased pain free light exposure in adults and adolescents with a history of phototoxic reactions from EPP or XLP.

Study Sites: There will be 12 study sites in the US, followed by global study sites across multiple countries. COLUMBUS, OHIO and BOSTON, MA NOW OPEN!

Age Range: Patients age 12 - 75

Travel: Will be included and will be arranged by a concierge service trained on EPP/XLP.

Please contact the American Porphyria Foundation for more information and we will connect you with a study site nearest you. Email info@porphyriafoudnation.org OR call 866-APF-3635 (301-347-7166).

We look forward to hearing from you!
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Frogster
Posted on: May 20 2020, 09:56 AM


Group: Member
Posts: 692

UBS healthcare conference slides.

Read to me like a fairly rounded general presentation of the company, history and direction. As you would expect for this type of product, not much new that will surprise anyone here i.e. no new details on timelines, financial goals etc.

https://www.asx.com.au/asxpdf/20200520/pdf/...z58ck3dn2gd.pdf
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Frogster
Posted on: May 19 2020, 10:05 AM


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Posts: 692

Newsletter out.
- re-emphasis on controls to avoid off label use.
- CUV105 mentioned in Vitiligo pathway - it looks like there will be 2 trials after all.
- DNA repair pilot study CUV150 waiting ethics approval but "optimistic able to start dosing soon".
- some reference to new insto shareholders.
- extended supply of Scenesse in the US to a 71 year old, beyond the label limiting it to 70.
- nothing of note on entry to China.

https://www.asx.com.au/asxpdf/20200519/pdf/...y5j8k8vlqq2.pdf
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Frogster
Posted on: May 18 2020, 11:50 AM


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Posts: 692

All very relevant points which would be great to see clarity on.

I'd particularly like to see clarity on the vitiligo path. The March PR in which they published the date of the Type C meeting suggested it would be to discuss CUV104 and CUV105. The early May post Type C meeting PR mentioned amending the protocol for CUV104 and the step of making a sNDA, but had no mention whatsoever of CUV105. I'm hoping that means there won't be an issue of running trials sequentially or concurrently, but rather, subject to satisfactory results, that only one further trial is required.
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Frogster
Posted on: May 14 2020, 05:45 PM


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Posts: 692

I'd rather they keep cash on the balance sheet, or use it to fund trials and research. To me, share buybacks are for companies which have run out of ideas in their core competencies, and we know, if they are good to their word, they'll have lots on new expenses in coming years. Assuming, that is, that you meant buy back and cancel shares. If you meant buyback, hold in treasury to sell back to the market later, I'd still rather they didn't. I don't generally think companies trading their own stock is a great idea, especially one as illiquid as CUV.
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Frogster
Posted on: May 10 2020, 02:12 PM


Group: Member
Posts: 692

I thought Blijdorp came across as graceless and spiteful in that letter.

Yes, in the last few months the company has delivered some pleasant surprises. This, finally, after many years of missed deadlines, broken promises, selective communication and "generous" descriptions of corporate progress. Longstanding shareholders have every right to question the Board and management, and to try and hold them accountable. I expect most would prefer to have those conversations in private, but they fail to engage in a manner where that is possible, even after they employ a full time Investor Relations manager.

The fact that the Chair seeks to ridicule those who have expressed concern, and that he seeks to isolate and minimise them (Only 5% unhappy? Wasn't it closer to 40% who voted against the package despite the company disenfranchising as many security holders as it can?) is unbecoming. It's been mentioned elsewhere that despite many of us not considering that package as appropriate, it was approved and I think most of us had moved on. If anyone involved in CUV should be able to take the higher ground, look forward and lead a reasonable, inclusive discussion of the successes it should be the Chair. Instead, he chooses to regress and pick off the scab covering the wound. He's attacking those who, despite their concerns, appear to have further underlined their interest in the holistic direction of the company by buying more shares. Odd. Most companies would love to have such engaged and committed investors.

I think he's also presented the management team as extraordinarily avaricious. They would have left if the package had been voted down? So, that was the minimum package that would have kept them happy? They wouldn't have stayed for 50%, or even 75% of it? Really? Wow. Just wow. Why did he bring this up? He really didn't have to. It just makes them look bad.
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Frogster
Posted on: May 8 2020, 10:45 AM


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Posts: 692

A damn sight more than 5% of votes were cast against that remuneration package! I think he's underestimating the disquiet around the scheme which no doubt was largely due to the numerous targets/timelines missed by this management to that point in time.

It's a shame this Chairman, along with the last, fails to grasp that the ONLY stakeholders who have a valid right to comment on strategy/management/remuneration are those who hold, and continue to hold, shares. That's why they come with votes attached!
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Frogster
Posted on: May 8 2020, 08:52 AM


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Posts: 692

And another. BBC website today:
https://www.bbc.com/future/article/20200505...-attacks-itself
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Frogster
Posted on: May 7 2020, 04:21 PM


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Posts: 692

Homm?
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Frogster
Posted on: May 1 2020, 06:12 PM


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Posts: 692

Xray, didn't you forget something?
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Frogster
Posted on: May 1 2020, 05:18 PM


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Posts: 692

Cut and paste from FAQ section of CUV website:

"The approval of the European Medicines Agency (EMA) of an exclusive marketing period for SCENESSE® (afamelanotide 16mg) to treat patients with erythropoietic protoporphyria (EPP) was granted in June 2014. As an orphan designation, the period of exclusivity is ten years. The market exclusivity is extended by a further two years for an orphan-designated condition when the results of specific studies addressing the paediatric population are acceptable and completed in a fully compliant paediatric investigation plan. Assuming no extension to the original period, expiry of exclusivity will be June 2024.

Any new, alternative treatment for EPP would be expected to obtain regulatory approval from the EMA with an obligation to substantiate the efficacy and safety attributes of the treatment. This would need to be based on clinical research and Phase II and III studies.

It is important to note that SCENESSE® (afamelanotide 16mg) is a complex formulation, not easily replicated and is also patent protected for a period beyond the expiry of the exclusive marketing period. CLINUVEL has also built a distribution network of accredited porphyria centres in which physicians prescribe SCENESSE® as part of their consultative relationship with EPP patients. CLINUVEL has also reached agreements on the reimbursement of the cost of SCENESSE® with insurers in each of the countries in which it distributes SCENESSE®. Any new pharmaceutical business seeking to treat EPP patients would need to do the same.

These arrangements are not easily or quickly replicated. Therefore, a reasonable assessment would be that there are a range of barriers to entry to a new or alternative treatment of EPP in Europe, even after the regulatory exclusive marketing period expires."

and

"CLINUVEL has a range of patents to protect SCENESSE® with expiry dates ranging from 2026 to 2033."


So, market exclusivity for EPP in Europe may have 4 more years to run. This could yet be extended, but even if it wasn't there are patents, notably around the controlled delivery methodology, which extend beyond the market exclusivity period. In the bigger market of the US, the exclusivity period will run longer than in Europe. Of course eventually market exclusivity will expire in both Europe and the US but the knowledge that CUV is building up regarding the patient registries and specialist centres will be hard for others to replicate and we might assume that will give CUV a strong defensive commercial position. Of course product life cycle management will be important, and that's why they need to continue to expand into other indications. As we know, they are planning to do exactly that. So, will exclusivity expiry affect profits from EPP? Eventually, yes, but it's not a major concern to me at this stage. If all goes to plan EPP profits - which are, remember, only a foot in the door of market potential for afamelanotide - will be replaced by multiple larger profit streams.
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Frogster
Posted on: May 1 2020, 02:39 PM


Group: Member
Posts: 692

What a couple of weeks of newsflow. Quite amazing what we’ve learnt. To recap:

1) Confirmation from patients that implants are being administered in the US.

2) Commentary from the APF that CUV is working hard to open further expert centres in the US.

3) Commentary from the APF that they are seeking to help non-US based patients access Scenesse.

4) Selective disclosure by LH to PinkSheets that a dozen European countries are on-line (would be nice to get these officially detailed as a dozen is surprisingly high).

5) Surprise entry to China via limited scheme which MAY lead to full access in short order (6-9m) after trial shows no ethnic disparity in efficacy . Potentially 5,000 patients i.e. of the same order as the US market.

6) CUV beginning to describe Scenesse in terms of vaso activity and anti-phlogitism at almost exactly the point we find they registered a trade-mark (Prenumbra) which just might be useful as a stroke treatment/preventative.

7) 4C cash flows show surprising resilience in the face of CV19 and plateauing Euro roll out, and currency benefits help to offset the temporary lull and actually see cash reserves climb to $62m. Pleasing to see a fuller, more complete discussion of what was behind the numbers.

8) Positive feedback from crucial FDA type C meeting which confirms a constructive relationship between the two parties and suggests that one, not two, US Vitiligo trials will suffice before an sNDA is submitted

9) Evidence that the “story” and, more importantly, the prospects over the next few years are now strong enough to attract the vey top tier of active institutional investors as GSAM increase their stake, and Capital Research, one of the most thorough fundamentals driven houses there is, leap to the top of the insto list with a 2.5% stake.

It’s exhausting. In a good way. What did I miss?
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Frogster
Posted on: May 1 2020, 09:38 AM


Group: Member
Posts: 692

Type C meeting comments. Not too much detail at first glance.

No new timelines, or detail around CUV104. No mention of CUV105 however. Does this mean only 1 further trial will be required?

“It is our goal for CLINUVEL to be the first company to launch a pharmaceutical product which addresses the unmet needs of the most severely affected vitiligo patients.”
Attached File(s)
Attached File  02231253.pdf ( 551.85K ) Number of downloads: 115

 
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Frogster
Posted on: Apr 28 2020, 08:19 AM


Group: Member
Posts: 692

Desiree Lyon on a public facebook group today:

"Re: SCENESSE We at APF spoke with a representative from Clinuvel today. They are working very hard to open more treatment centers. Also, they are helping individuals with insurance and assistance needs.

First , however, epp people need to register on Scenesse.com to receive an ID number . Having the ID number is essential to receive treatment, assistance , insurance help, etc. Please secure your ID number today at Scenesse.com! Call APF if you need us."
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Frogster
Posted on: Apr 27 2020, 07:15 PM


Group: Member
Posts: 692

That's very interesting. I wonder if it ties into the way they are now describing afamelanotide. In the "Chinese" media release from last week they included the following statement:

"Afamelanotide, a potent hormone and the active ingredient in SCENESSE®, acts as an anti-oxidative, strengthens blood vessels (vaso-active) and reduces swelling (anti-phlogistic) protecting patients against any light source and ultraviolet (UV) radiation."

I'm no doctor, but wouldn't something that is vaso-active and anti-phlogistic have application in a penumbra event?

I don't recall CUV being quite as direct and succinct in describing these qualities of afamelanotide previously.
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Frogster
Posted on: Apr 23 2020, 03:48 PM


Group: Member
Posts: 692

https://www.ausbiz.com.au/media/clinuvel-ph...;sectionId=1886

PW "interviewed" about the China announcement from this morning. You might need to sign up to ausbiz (free) to watch it.

The questions asked aren't the most penetrating or relevant ones, but there are some mildly interesting details:

- discussions with Winhealth have taken 2 years (hmm, why no comments about China being a strategic goal previously?)
- local partner required since CUV doesn't know local healthcare practices well
- of the 35,000 hospitals in China, Winhealth has access to 2,000
- CUV is "confident of commercial success in China"- Winhealth has grown impressively, from 5 employees in 2006 to 1,000 now
- Japan is till a target

No comments on precise timing or process of pilot programme.
No discussion of process that would see pilot grow to full launch.
No discussion of commercial terms or pricing expectations (beyond vague comment that commercial success is expected).
No discussion of how intellectual property will be preserved and defended.
No discussion of Scenesse and it's relevance to Covid 19.
No statement if the first commercial US implant has actually yet taken place

It's a shame they haven't made more of what could be a very exciting long term development, and it's shame PW didn't consider the camera angle a bit more carefully prior to the interview.
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Frogster
Posted on: Apr 23 2020, 09:50 AM


Group: Member
Posts: 692

Looks like they've been saving all the positive surprise announcements till this year!

Credit where it's due: nice work LH and the wider management team.
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Frogster
Posted on: Apr 21 2020, 05:17 AM


Group: Member
Posts: 692

From the Capital Group website:

"On average, the equity-focused American Funds hold their investments for 3.14 years, whereas their peers hold their investments for 1.82 years, based on the equal-weighted blended averages across each of the 18 equity-focused American Funds’ respective Morningstar categories. Please see the bottom of the page for a list of each fund’s respective Morningstar category."

This comment might not directly relate to whatever fund they hold Clinuvel in, but it's a solid indicator of their style.

Deep research, long holding periods, high conviction investing. Proper cornerstone investor material. These guys don't just "take a punt" on stocks like a hedge fund might. They are not fast money. They are rolled gold, premiere league, top tier, A1, superfine institutional investors. For those who don't know them, they are worth reading up on

https://www.capitalgroup.com/individual/abo...-term-view.html

If anyone needs validation of their own investment decision, this could be it. I seriously can't think of another institution I'd prefer to see join us on the register.
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Frogster
Posted on: Apr 20 2020, 07:46 PM


Group: Member
Posts: 692

Wow. Just wow.


Capital is one of the most serious investors out there. They do not muck around. It's been a few years since I dealt with them, but their research capabilities and detail they go into is second to none.


They demand a lot of the companies they invest in, and they do not do also rans. Given the way the company communicates with us, and the lack of 3rd party coverage, I'm a bit surprised at their interest, but it's a great sign.


They typically build significant stakes. 2.45% would not be big by their standards.


I'm happier to see them on board than I was having fidelity on the register back in the day.


Awesome stuff. If the shorters weren't getting nervous, they should be now.
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Frogster
Posted on: Apr 17 2020, 05:38 AM


Group: Member
Posts: 692

A few access details and confirmation of the 3 initial centres from the APF:


CLINUVEL PHARMACEUTICALS LTD today announced that US insurance companies have agreed to reimburse SCENESSE® (afamelanotide) for patients diagnosed with erythropoietic protoporphyria (EPP). Other topics of this press release include US Distribution of Scenesse, US Insurance Coverage of Scenesse and Scenesse Savings Program. Here are a few things that you should know:

The following US centers are trained and accredited, as approved by the US FDA, to prescribe and administer SCENESSE®:
Henry Ford Hospital - Detroit, Michigan - Division of Dermatology Center - Dr. Henry Lim
Vitiligo and Pigmentation Institute of Southern California - Los Angeles, California - Dr. Pearl Grimes
Resnik Skin Institute - Aventura, Florida - Dr. Barry Resnik

Following the phased launch of SCENESSE®, a maximum of 30 Specialty Centers are being trained and accredited by CLINUVEL for the prescription and administration of the drug.

Accessing Scenesse:
EPP patients will need to contact their insurance providers to obtain the Medical Policy confirming insurance coverage for the treatment with SCENESSE®;
The Specialty Center prescribing physician will submit Prior Authorization to the insurer;
Once the insurer has granted Prior Authorization approval, the patient will be contacted by the prescribing physician for an appointment;
CLINUVEL will receive an order from the prescribing physician to supply the drug;
EPP patients will be asked to sign consent forms to capture safety data which will be entered anonymously into the Global EPP Disease Registry database;
EPP patients will be followed up for eight years; that means that patients will be asked to report to the prescribing physician for eight consecutive years or report by phone so that their well-being can be recorded for FDA analyses.

Any other questions can be directed to us via email at info @porphyriafoundation.org or via phone at 301-347-7166.

Please click on the link below to read the full press release!

Clinuvel Press Release for SCENESSE®
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Frogster
Posted on: Apr 16 2020, 10:02 AM


Group: Member
Posts: 692

Media release on top of the ASX release:
Too bad the ASX release wasn't marked as price sensitive.


Attached File(s)
Attached File  02225347.pdf ( 293.35K ) Number of downloads: 181

 
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Frogster
Posted on: Apr 16 2020, 09:34 AM


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Posts: 692

Official CUV line: first US treatment in the coming days despite the pandemic.

Nice work CUV.

Attached File(s)
Attached File  02225334.pdf ( 348.41K ) Number of downloads: 154

 
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Frogster
Posted on: Apr 14 2020, 11:21 AM


Group: Member
Posts: 692

You, sir, have a mind like a sewer, but do you also have a heart like a fridge?

(Seemingly not busy enough......:-))
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Frogster
Posted on: Apr 14 2020, 11:05 AM


Group: Member
Posts: 692

If you can liken the FDA to the EMA, then I guess you can liken the US insurers to the individual European national central payor agencies.
They appear to have quite a lot of insurers on board already, so perhaps we can hope the US roll out will be far faster, smoother, deeper and effective than the European slow march, coronavirus or no coronavirus. That'd be a nice surprise for patients and investors alike.
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Frogster
Posted on: Apr 14 2020, 10:53 AM


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Posts: 692

Great work. Thanks very much Johnny.

I'm excited and intrigued for tomorrow. They put out a press release when the first commercial delivery was made in Europe. Presumably the same will happen for the US and hopefully that's very, very soon.
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Frogster
Posted on: Apr 7 2020, 10:23 AM


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My interpretation of the April 15th launch detail is the 15th is the date you can start seeking prior authorisation, filling paperwork and booking of appointments. I don't expect the first treatment on that day, but I would hope to see it within a couple of weeks. If it's earlier than that, it'll be very pleasing.
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Frogster
Posted on: Mar 23 2020, 01:45 PM


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Too bad the AAD Denver conference didn't go ahead 20/3-24/3. Would've been a great platform to be shouting the news from. Oh well.
Great news for patients, and none too shabby for shareholders too.
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Frogster
Posted on: Mar 19 2020, 04:50 PM


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DPI200ply.
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Frogster
Posted on: Mar 19 2020, 12:57 PM


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In these turbulent times, I found this newsletter to be vaguely comforting. Not because there's any groundbreaking, investable news but probably rather because there's not. Seeking headlines is not the CUV way. Quietly working to their own secretive timeslines is, and that's what they're doing still. When markets are skyrocketing, they plug away. When markets are crumbling, they plug away.

There's the usual slight smugness ("we prepped for this" - maybe not Covid 19 explicitly, but yes, your balance sheet management has been very conservative and that is currently a wonderful strength to have).

There's the usual unanswered contemporary questions (no comment on Scenesse as a Covid treatment, no commitment to US launch schedule).

There's the usual pointers towards a wonderful long term potential (Vitiligo pathway, DNA repair trial agreements within weeks).

There's the "unusual" use of language.

Bravo for publishing the Newsletter on schedule. Bravo for conveying, in the current climate, a rare sense of normalcy.

I don't always agree on their balance of what they say versus what they don't, but for these times that's OK. I'm still here for a few more years yet.


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Frogster
Posted on: Mar 14 2020, 07:21 AM


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https://asic.gov.au/about-asic/news-centre/...o-be-disclosed/

"The practical effect of this action is to require most short sales to be covered." though this comment only refers to naked shorts.

From what they did in 2008. Obviously the technicalities could vary this time around if another ban is introduced, but it's interesting history to be aware of.


More detail here:

https://asic.gov.au/regulatory-resources/ma.../short-selling/

if you are keen.
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Frogster
Posted on: Mar 12 2020, 02:46 PM


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Maybe. However outrageous management remuneration comes as a package with outrageous shareholder expectation.
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Frogster
Posted on: Mar 12 2020, 01:55 PM


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Pretty pathetic in my opinion that 5 months after FDA approval they are still terrified to commit to an indicative month or quarter. It's uncomfortable for us, but outrageous for patients. If their execution skills are as perfect as they'd have us believe, why is such a commitment so hard for them to make? Are they scared they might fail to hit a deadline again or something?
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Frogster
Posted on: Mar 6 2020, 11:30 AM


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Their announcements calendar has them publishing a scientific communique at the end of February (last week ish) and a Newsletter mid march (next week ish).
These could be useful scheduled communications opportunities to explain all and ease our worries. Let's hope they take those chances.
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Frogster
Posted on: Mar 5 2020, 12:13 PM


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Through to last Friday, the shorts have continued to fall. Down a full 1% from their high (9.22% on 24/2 to 8.22% on 28/2). Shortman data was just updated.


https://www.shortman.com.au/stock?q=CUV
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Frogster
Posted on: Mar 5 2020, 07:00 AM


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What do you think are the chances CUV will announce the US launch of Scenesse, or at least announced the launch process, at this March AAD conference?

"This is the first time we will discuss our work in the photomedicine field as a meeting exhibitor. Stay tuned for pictures and live updates!"

It sounds like they are planning on being more than just wallflowers, and surely this would be too good an opportunity to pass up.
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Frogster
Posted on: Mar 5 2020, 01:27 AM


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"Please note that SCENESSE® is not suitable for patients involved in clinical trials for other EPP treatments."


From the scenesse.com website which went live yesterday. Coincidental timing? What would the chances be? CUV wants people to know this, as I'm sure the APF do.


Hopefully CUV is prepared and proactive in rolling out an effective commercial strategy because MT seems to have it's approach ready and it doesn't involve fumbling along at a snails pace.


It's a bugger of a choice for patients. Enrol from April in a trial for a year that may/may not result in a new treatment a year or two later, or wait an unclear amount of time for an approved long term proven drug.
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Frogster
Posted on: Mar 3 2020, 11:06 AM


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At the most recent AGM they suggested 2 vitiligo trials on the "summary" slide (CUV104 and CUV105 both mentioned).

My notes from the meeting also suggest Wolgen wasn't sure if 1,2 or 3 trials would be needed, but that he expected the FDA wanted 2.

In the past (as recently as October 2019 newsletter, just before the AGM) they mentioned a proposal to advance "a US-UK trial" and that "the final protocol has been agreed".

Today they're saying the type C will be to discuss "the proposed study protocol design" and that the trials are to be conducted in North America - no mention of UK.

So, they're offering some pretty inconsistent indications of the expected path to approval, and where they stand on it. It's the Clinuvel way. In the end, they will do what the FDA tell them to do and in that context the type c meeting is a step forward.

Macgyver: not sure that was me. I did mention the other day that the 2017 slides pointed to a vitiligo type C meeting in late 2018 (can't remember if it happened or not). Recently there was a discussion from Farma about whether a pivotal 2b trial was possible which might lead directly to an sNDA. Is that what you're thinking of?
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Frogster
Posted on: Mar 1 2020, 01:31 PM


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You have accountants everywhere spitting their Sunday brunch croissant into their lap right now. I've got some experience navigating Annual Report and Accounts, but I'm not one of those lucky guys who gets to put them together. As to Gandalf, he gets to hang out with the coolest creature in all those films - Shadowfax - so that's fine by me. :-)

After a pretty brutal couple of weeks, I found myself yesterday rereading some old releases. I found some of the content of the 2017 AGM papers interesting in hindsight. These were the "Growth 2020" slides. These papers were the last ones I remember to have given thorough indicative milestones/timelines. The key points they pointed to were:

Europe & Aus
Early 2018 New website: delivered, including Latin tagline
Early 2018 CUV103 results: delivered, but late 2019
Late 2019 File with TGA: delivered, but late 2019
Early 2019 Label extension 4 to 6 doses: not delivered
Early 2010 1st PK trial Scenesse Enfance: no where to be seen

Asia
Late 2018: Launch CLINUVEL skincare solutions through 2 distribution channels: nope, never happened
Late 2018: File Scenesse with PMDA: nope, not yet
Mid 2019: CUV9900 PK study: nope, don't think so
Early 2020: First CUV9900 results: doesn't look like it

USA
Early 2018: NDA submission: it eventually happened, but was very late
Late 2018: Type C FDA vitiligo meeting: not sure if this one happened, but another one is due mid this year
Early 2019: FDA decision due: late, but at least positive result in late 2019
Late 2019: First US patient treatment under NDA: nope, not yet

We all know about the above. Loads of missed timeframes, lots of delays. Can you really plan all these things, and then just not follow through?

The slide on p19 from that AGM got me thinking about things a bit differently. This is the slide that extrapolates the "High" cashflow scenario first presented at the AGM 2015. Actual cash flows tracked really quite well with the "scenario" this slide presented (remember, not a forecast - oh no, don't use that word!) through as far as 2018-2019. In 2019-2020 it looks like cash flow will be WELL short of the scenario in the graph. Why? US launch delay seems the obvious thing.

So, how to interpret this? I think from early 2018 they knew the NDA submission was going to be seriously delayed, and just put a hold on any planned spending. If it didn't have to happen, it could wait. Most of us have a few criticisms of PW for various things, myself included, but I don't think it's contentious to say he's shown very good, conservative capital and balance sheet management. Apart from incentive schemes, we've barely been diluted. He wants internally funded growth, even if it means slow development. We can argue is the balance is right, but there's something very positive to be said for this. I think he has a cash balance that he sees as absolutely critical to maintain, and now that we DO have visibility on US cash flows, it's time to loosen the purse strings a little because the means to maintain that balance are here. So, I'm beginning to hope that alot of those others things will now come at us at a pace. Sure, this will place something of a burden on the P&L, but if it's for growth initiatives, I'm OK with that, especially because the US launch will see cash flow and gross profit grow very quickly. Ultimately cash is king, so that's fine. The 2017 AGM slide that was very accurate in profiling cash generation from 2015-2019 suggests cash generation per annum will double (or more) within 12-18 months of US launch and keep going. My own model suggests EPP alone will see free cash flow of over $50m per year from after 21-22, including a big step up in R&D costs. That's not to be sniffed at. It also means that IF the MT drug works, and IF they bring it to market in 3-4 years time, we should already have a balance sheet strong enough to see us through all, or at least a majority, of getting other indications to market should they cannibalise our sales.

I'm not being an apologist for PW. I think he's sneaky, greedy, ambiguous, manipulative and has something of a glass jaw, but I don't think he's a cowboy when it comes to running corporate finances. I think his policies mean they do a dreadful job managing market and shareholder expectations, forcing us to speculate for explanations as I've just done. They'd get a lot more love from us if they showed us a little our way, but ultimately we're investors not life partners (though at 12 years plus for me, it sometimes feels like it). Overall, in light of the above, I guess I'm here for a few years yet.

Finally, something else struck me as interesting from those 2017 AGM slides. The USA timelines on p42 indicated first patients treatment 9-11 months after approval. It might be a case of hope triumphing over experience, but wouldn't it be nice if they actually hit that guidance!?!
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Frogster
Posted on: Mar 1 2020, 10:59 AM


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Glol.

So who is Frodo, who is Sam, and who is Gollum?
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Frogster
Posted on: Feb 27 2020, 04:53 PM


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Sorry to be a pedant, but they didn't withdraw the rights, they withdrew the 3B and 3Y which were issued in error. The rights were never issued. The question is why was that, when the scheme conditions were that they would be issued as soon as practicable. The first practicable occasion would surely be at the first Board meeting after the vote.
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Frogster
Posted on: Feb 27 2020, 01:33 PM


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Glad they've expanded so much on the most exciting topic presented at the AGM - DNA repair. Can't wait to see what they do with that!

wacko.gif
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Frogster
Posted on: Feb 27 2020, 10:52 AM


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I was initially of the opinion that the 3B and 3Y withdrawal was down to some kind of administrative screw up. Now I'm not so sure.


In 2014, the when the last incentive scheme was initially approved, the AGM was held on 28/11/14 and the 3B confirming the issuance of the related Performance Rights was published on 4/12/14, less than a week later. The scheme terms back then included the same phrase that Rights would be issued "as soon as practicable" after the meeting and that the Board had sole discretion over when exactly that would be. Presumably the Board had a meeting post the AGM, probably on 4/12/14, at which they formally issued Wolgen with those Rights.

I imagine that this time around (2019) Keamy, or whoever puts the actual press releases together, assumed the Board acted in the same way and published the 3B on 5/12/19 which has now been withdrawn. I'd assumed the error - the fact that the 3B was issued before the Rights themselves had been issued - was discovered by the Auditors in their mid year review who pointed out to the company the need for the correction.

I hadn't been too bothered by the "they've done this to extend the window PW has to collect the shares" arguments that have been put forward on here since I remembered that 3 years after the 2014 vote on the scheme, we got to "refresh" our approval at the 2017 AGM since that scheme was issued under ASX listing Rule 7.2 exception 9 which requires a renewed vote every 3 years. So, I was thinking we'd be able to vote in 2022 on refreshing the 2019 scheme. If progress not so great, the ability to vote it down was there.

On looking into it, however, the 2019 Rights scheme was issued under ASX listing Rule 10.14 which does NOT require the vote to be renewed every 3 years thus giving the scheme a longer life should shareholders not be happy with progress - there appears to be no ability to refresh the vote on this scheme.

So, why delay issuing the Rights this time round? Surely there have been Board meetings since the AGM so there have been opportunities to issue the Rights - and I can't believe they would've forgotten about the scheme - so the delay must have been intentional. What happened to the as soon as practicable condition? This smells to me, and demands proper explanation.
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Frogster
Posted on: Feb 26 2020, 01:12 PM


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Weak top line growth (which we knew from the quarterly cash flows) combined with a big increase in costs (which we expected, but were never quantified) have seen margins contract massively (45% pretax margin H1 18/19 vs 11% in H1 19/20). I expected margin contraction, but am a little surprised by the magnitude. I think if CUV had ever got into the territory of issuing profit guidance previously, then these results would probably have warranted a profit warning at some stage. If you like, this could be our equivalent to the NEA warning of a few weeks back, and I would not be surprised if this margin trough is what the shorters have been betting on. NEA shorts have reduced by 4% in the last few weeks, and I wonder if we might slowly see something similar from here.

The higher costs at CUV are obviously part and parcel of the US roll out, and the funding of longer term initiatives leading to longer term growth. Will this reporting period mark the low point of the margin cycle for the foreseeable future? I think there's a good chance it will, and I'd expect expanding margins to once again benefit the corporate worth.
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Frogster
Posted on: Feb 25 2020, 03:02 PM


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They just don't seem to be able to let go of this kind of incompetence, do they?
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Frogster
Posted on: Feb 25 2020, 09:35 AM


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Only 504 days since NICE appeal was upheld too.
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Frogster
Posted on: Feb 19 2020, 12:30 PM


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It's a nice, investable presentation. Strategy, tactics, revenue opportunities and timelines. It's all there. /sigh.
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Frogster
Posted on: Feb 14 2020, 09:06 AM


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If the inability of competitors to do comparative or bio equivalency trials is an advantage to Scenesse and Clinuvel, then that only holds if they can't source Scenesse samples. This, to me, is one of the main advantages of self distribution - complete control of who gets Scenesse and for what.
It also means, no matter how legal it is for a physician to prescribe off label use, off label use is effectively prevented by Clinuvel. Its the way it works in Europe. It looks like it'll be the way in works in the US, and I'd be surprised if it's any different in Australia or elsewhere.
I'm not so sure it'll be possible to maintain this policy in the long term (when mass distribution for other indications is required) but I think it's good for a few years yet.
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Frogster
Posted on: Feb 10 2020, 06:36 AM


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Dr Wally: if long term detailed efficacy/safety follow up goes to support or even prove dna repair/cancer protection/cancer curative properties in a reasonably wide longish proxy phase 4 study based on reliable data, then that's the kind of virtue I'd be very glad for them to signal.

seeva222: agree on the rollout. Doing stuff on the cheap has it's place, but that place is not when every dollar not spent now delays the payback of multiple dollars in the near term. I can only hope the apparent lack of planning and foresight is just that, an apparition. Wolgen stated around approval time they need to accelerate their activitities. Let's hope they can and are, even if they are hiding this from our view.

KRD: thanks for pointing those out, they back up the impression I had. Your vitiligo comment makes sense too.
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Frogster
Posted on: Feb 9 2020, 04:42 PM


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Wolgen has made it 100% clear for a very long time that they would distribute Scenesse in the US under a similar controlled system to that they use in Europe.
Was this a requirement of the FDA or an offer by the company? It's not totally clear to me, but my sense is that it's more of the latter than the former. I believe Wolgen sees value in building more detailed efficacy/safety data that a very close follow up arrangement would enable, and I can see value in that too. It also, rightly or wrongly, will enable them to prevent the drug being used in uncontrolled cosmetic scenarios. This has been one of their other touchstones for a long time and I don't think anyone should be surprised by this.

What is disappointing to me is that they do not appear to have been well prepared to hit the ground running with the roll out. At the very least it seems they are not confident of their ability to execute it to published timelines otherwise why would they leave us - and of course patients - in the informational limbo we currently inhabit.
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Frogster
Posted on: Jan 31 2020, 10:04 AM


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On your point 4, I assume you are referring to the AGM held 20/11/19 and not 2020. The 6th presentation slide from that meeting states a retention rate >94%. Your assumption that the retention rate is cratering since their presentation "No longer mentions continuance rate" appears misplaced.

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Frogster
Posted on: Jan 31 2020, 09:53 AM


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Today gives us more evidence European sales have, for the time being at least, plateaued.


For the last 4 quarters, the prior 12m aggregate receipts have been in the $29.6m-32.4m range, and for the last 3 it's been $32m +/- which means there's 1 more quarter where the comparison base is relatively easy to show good growth (double digit) from. Beyond that, to see RFC growth, we'll need to see a) deeper penetration in Euro markets where Scenesse is being distributed, b) entry into new markets in Europe, c) the much anticipated US launch.


On the basis of recent figures and known activity, a) seems hard to achieve, b) seems possible, but doesn't appear to have been much of a focus lately (what's happening in the UK with NICE? The AGM suggested CUV has done nothing to follow up since winning the appeal. What's happening in France, or other markets where there are no sales?), c) is obviously the big one we're waiting for.


I'd love to have an indicative launch date from the company. 4 months after FDA approval there should be some clarity (I'd hope) and in the absence of a) and b) it'd be very nice to get some comfort, or at least the anticipation of comfort, from c) since it looks quite possible that we'll fall into a few quarters where rolling 12m RFC growth is low or even negative. That would surely only be temporary, but I expect we'd all like to know just how temporary.


I'm glad to see a slightly more useful qualitative commentary about what's driving the rest of the cash flow detail. Building for growth is pleasing to see, and I'd love to know just how much of the big jump in staff costs has gone on the headcount increase and what/where that headcount is. I'm hoping it's on someone with current US commercial experience.

The future is still full of green fields and honey, but there are still a few twists and the turns in the road to get there.
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Frogster
Posted on: Jan 31 2020, 08:42 AM


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Quarterly out.


Attached File(s)
Attached File  02197371.pdf ( 237.92K ) Number of downloads: 116

 
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Frogster
Posted on: Jan 28 2020, 12:54 PM


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Thanks KRD. My approach to guesstimating the quarter is as follows:

Aggregated average quarterly revenues since FY12/13 through to FY18/19 show a split of 29%, 16%, 16% and 39% for Q1 to Q4 respectively. So, if the historical patterns hold, then the quarter should be 16% of whatever is expected for the full year, excluding any US launch since that'll skew the data significantly. It's not a perfect approach, but a reasonable one in my view.

I'm hoping for annual receipts excluding any US contribution of around A$40m, which would put quarterly receipts at A$6.435m. I must say that "feels" high to me, but then Q119/20 was a little light, and therefore perhaps that quarter saw some timing issues. Q218/19 was also quite a weak quarter, so the YOY comparison will hopefully look quite good.

Obviously the timing effects of payments can be significant especially in the quieter quarters, so, overall I'll be happy if the receipts are around A$5m, and the company generates a little cash.

As seems to eternally be the case with CUV, what's happening next will be probably more important than what happened last year. Most significant would be any commentary around US launch schedules, but I'm not expecting we'll get any detail at this stage.
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Frogster
Posted on: Jan 20 2020, 01:13 PM


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Don't worry Johnny, I'm sure with the wealth of recent US commercial pharmaceutical experience they have on the Board that the tardiness in getting the product to patients and making sales is all part of what will come to be described by said Board in due course as "a perfectly conceived and executed launch plan".
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Frogster
Posted on: Jan 16 2020, 04:30 PM


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My understanding of the 7 years of market exclusivity for orphan drugs is that it is there to provide protection from generic competitors in a given condition - see flyer linked below for simple evidence of this. The FDA is not allowed to grant an approval for the same drug in the same condition in that time frame.

I'm not aware of any FDA restriction in developing and approving a different drug for the same condition and of course a different drug is by definition not a generic.

https://www.google.com/url?sa=t&rct=j&a...ZpwmTIZdXETTP7A


I think CUV was simply a little too general in it's wording and should've said "generic competitors" when it said "competitors".
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Frogster
Posted on: Jan 16 2020, 02:40 PM


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In CUV land it remains the case that frequency is more important than content when it comes to communications.
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Frogster
Posted on: Jan 9 2020, 01:04 PM


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"Or....neither and it is just standard clinuvel business as usual."

This.

Under this management team, Clinuvel will never explain, share important details or allow investor access to management. It's an important part of their strategy, and they don't take kindly to those who think it's the wrong approach.

It's their M.O.. I wish it wasn't. I think it's an approach that cuts out many potential institutional investors and brokers who expect a higher level of transparency and accountability.
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Frogster
Posted on: Dec 13 2019, 10:14 PM


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The analysts at major brokers will be very reluctant to initiate coverage on a stock that won't provide access to management or even answer basic questions. We know from Sphene this is the approach they have taken to enquiries from actively interested parties. Some might do it, but it would be very reluctantly.

I think this approach is also a major factor in why we have only limited institutional ownership. The likes of Fidelity and Capital Intl direct their commission flows in part to the brokers who can provide best management access. No management access/non responsive IR will normally mean no investment.

This approach from CUV is a policy. They don't want scrutiny from anyone. They want well behaved, quiet capital that doesn't challenge them.

I don't think they'll change with this management team on board.
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Frogster
Posted on: Dec 4 2019, 10:06 PM


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We know he was an analyst. Do we know he was successful? I've known many who weren't.
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Frogster
Posted on: Dec 3 2019, 03:02 PM


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Does anyone else think the strongest argument right now for PW to come up with a credible execution gameplan for achieving US roll out, vitiligo and DNA repair commercialisation is just to stop the bickering on this board? Hell, if he can do that I'd probably even vote him a few more shares!
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Frogster
Posted on: Dec 3 2019, 06:19 AM


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No it's not. Are you forgetting they also have a board member with high level contemporary commercial US experience steering the roll out and that means all we have to do is trust Wolgen when he says we should?
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Frogster
Posted on: Dec 2 2019, 06:36 PM


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I think it's well known on this board that orphan exclusivity protects against generic competition in the given condition only.

I think it's also well known that Scenesse has an advantage over any new entity entrant that would have to show a clear advantage over it.

The efficacy of 7117 in comparison to Scenesse is unknown. The safety profile in comparison to Scenesse is unknown. The pill form has an arguable advantage in ease of use, but that has to be argued against controlled, sustained release of the implant.

7117 is certainly worth watching closely, but there is also a need to remain level headed in discussing it.
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Frogster
Posted on: Dec 2 2019, 09:22 AM


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An attempt at calming verbiage which I guess is nice in intent, but still no details at all on time lines, dates, specific therapeutic targets etc. etc.. How long have we been waiting for the fabled 3rd indication to be clarified? How long have they been preparing for trials? Sounds a familiar story to the VP trial which should've been done and dusted by now. Also, what's with the final chapter rubbish? Do they sit on their hands beyond this point?

Wolgen's AGM effort has been praised for talking the DNA concept up, but widely criticised for it's lack of investable detail around it. To me, this letter is little different, and I'd like to see them do better.

The CEO has his share package, the management have theirs, there's a new Chairman and 2 new Board members. Time that CUV upped it's rate of delivery.
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Frogster
Posted on: Nov 30 2019, 01:25 AM


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If the gold standard P3 trial was for MT to do a comparative study, given CUV has complete and total control of distribution, how would MT get hold of the Scenesse implants it would need? Surely CUV can't be forced to supply for purposes that might harm itself? Therefore, could a gold standard comparative trial even be possible? Maybe this defensive benefit is part of the reason CUV has taken the control path it has? It'd help keep generics at bay later down the track too.
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Frogster
Posted on: Nov 26 2019, 05:42 PM


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Sorry to leave you hanging Macgyver. I've been on holiday since the AGM and had more interesting things to do than type up thoughts on CUV. However, today I've returned to reality and ground out the following for you. Not in any particular order, and repetitious of some comments made here since the AGM by others. In summary, to me, Clinuvel remains the Curate's egg of the investment world. Some things about the company bug me and, I expect, will continue to do so, but the trajectory remains a compelling one.

Management Remuneration

PW has got his rights package across the line. In my view, the quantum he demanded was excessive, but it’s done now and I hope the milestones are achieved swiftly. I actually consider the trojan horse methodology of pushing a generous management equity scheme through as more significant than the package for PW. We all know that he has built a very tight team around himself. They have shown him great loyalty, and he to them the same. He’s now ensured that with modest further positive corporate developments his team will become wealthy, and with major success, they will become stonkingly rich. If you’re “in” with PW, there is no doubt that he’ll fight for you.

So far the estimate of how much might fall to management below PW sits between 5.8 (MattCUV) and 8.8% (me). The trojan horse approach of getting Blijdorp to make the detail of the scheme “public” by announcing it in the meeting to me is pretty sharp since 1) no indication of scale had been given to those who awarded proxy votes to the chair (directed or otherwise) 2) the detail was given only seconds before voting occurred 3) the details themselves were hard to understand (several other attendees I discussed this with found it equally as unclear as I did) 4) Given the detail was not delivered by the Chair or the CEO, it’s content hasn’t been disclosed to the ASX.

I’ve asked CUV IR for the detail of what Blijdorp said, but I’ve received no reply to that request. I promise I asked for it in a very civilised manner so I don’t understand why I’ve not had one.

I think it’s disappointing that they’ve gone about it this way, but it’s done. He, PW, has looked after himself, and now he’s looked after the team. Why is this so important? Well, I think it makes the possibility of takeover a far more palatable one for PW and the Board to look at favourably. Now, no one on the inside will miss out on the riches if it happens. I’m not saying I think it’s a short term certainty, only that PW now knows his team will all be just fine in the event one occurs.


DNA repair

I’m very glad to hear PW talk this up as the next stage. We’ve obviously all thought about the potential in the past, but to have the company admit this is the goal is great. CUV has set out it’s stall. It’s been said on here since the AGM, but this could be seen very easily as an attempt to entice a buyer our way. Again, maybe not today, but should there be success in those trials I could imagine something happening pretty quickly.


Timelines/Communications

I’m not shocked there’s no detail around the timelines of anything. A little while ago in a post on here I explained why I thought they’d not change their approach and I’ve posted it below rather than type it out again.

They can’t stand the scrutiny it brings when they miss timelines. PW will do much to protect himself and his team. They, the Board included, will not accept any comment that their execution hasn’t been perfect and so it seems like an obvious move from them to drop anything that enables objective and quantified commentary from the like of us when things don’t hit the plan. I think it’s a sign of corporate immaturity, and it’s disappointing, but not very surprising.

Stan M, in his outgoing commentary, makes the point that the quantity of communications betters that of their peers. However, he hasn’t addressed the quality of communications which, in my opinion, is often ambiguous, lacking in detail or inconsistent. However, they see no issue here. Until they do, nothing will change.


***
Personally, I'm not expecting their communications approach to change very much. I think they'll remain happy to communicate strategies in broad strokes - and it's an exciting strategy - but will continue to be light on making the detail public and very light on the opportunities to be questioned on those details as and when things vary from the broad stroke guidelines. Maybe the frequency of presenting those the strategies will increase (i.e. more investor conferences) but I'd be surprised if the content style changed much. They are great at stonewalling answers to questions, written and verbal, so simply doing more presentations doesn't equate to sharing more detail.


The company has achieved a tremendous milestone with FDA approval. They really have and I congratulate them for this, especially for their determination to get there, but the fact that extreme caution in communication was demonstrated by the way they ran the conference call. The approach of picking which questions they would respond to (the responses we're always answers in my opinion) smacked of this. They didn't need to do this. There were loads more questions that they just ignored.


I think it's simply the case that the cautious approach is their M.O. I can't see why PW would change this. He has never "pumped up the tyres" of any indication, and I don't think he ever will. I'm sure we'll get updated with milestones as they get ticked off - whether on time or delayed - but PW will never hype things. Having come to this realisation, I think I'd worry if he ever did. He's going to leave hyping things up to the likes of us.


Having crossed the threshold of FDA approval, I consider we're moving into a phase of exciting developments which have huge and lasting growth potential. I intend to hold my shares for a while yet, but I have little doubt that aspects of the "Clinuvel way" will continue to annoy the hell out of me for a long time to come, but I hope this will be tempered by what the growth does to the stock price. If they'd hired many proven, experienced operators to get us through the FDA quicker and run the paused programs in parallel I wonder what that'd have cost in total? Would that have left us in debt? Would they have diluted us significantly?


Without a change in management, I don't think there'll be change in management approach. That is, paint broad strategic strokes, keep the details close to your chest, manage cost conservatively and ensure a tension with shareholders by keeping relationships at arms length balanced by avoiding dilution and delivering earnings growth. Over the years that approach has worked for us, and may it continue to do so.

***


Board changes

Dr Sue Smith and Professor Jeffrey Rosenfeld both are highly credentialled new Board members. Dr Smith spoke briefly at the AGM, and I thought she came across well. I have high hopes they will revitalise the Board and bring a new and valuable independence which has been a little lacking of late. I think they have a large hole in Board level experience when it comes to contemporary commercial experience in a US setting, so I hope they are planning to supplement the Board with someone who knows their way around the current field of play. We can’t afford L plates in this role, and I hope the new Board members will quickly realise this.
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Frogster
Posted on: Nov 21 2019, 06:07 AM


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Lh2000, you are quite wrong. It might be hard to hear something when you are in the room. It's a lot harder when you aren't.

There will be dilution via rights issuance to management. You only have to get holders to vote on rights issuance to directors. It's the old sleight of hand thing again.
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Frogster
Posted on: Nov 20 2019, 02:19 PM


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So what seems to be missing from the discussion so far is that Bjidorp also addressed the meeting. This was immediately ahead of the voting section. He was reading from a prepared paper, but I can't see that this has been published to the ASX. I wish it were, because it was really hard to understand what he was saying.

He was encouraging shareholders to support Resolution 4. He also revealed the quantum of shares that will me awarded to management if R4 was passed and all the hurdles met. In my notes I think he mentioned 8.8% dilution from them. I'm not 100% sure on the figure since he stumbled on the delivery of it. I'm also not sure if that figure included or excluded the 3% dilution Wolgen personally could be awarded. This whole section was hard to understand.

It doesn't seem to me to be very appropriate to drop such significant dilution into an informal comment seconds before a vote, especially when the detail was not available to those who'd nominated a proxy vote.
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Frogster
Posted on: Nov 18 2019, 09:28 AM


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Is anyone on here a member of the Australian Shareholders Association? If yes, could you share their AGM voting suggestions for Wednesday? It'd be interesting to hear which way they're leaning.
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Frogster
Posted on: Nov 14 2019, 03:46 PM


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Now. If you are voting by nominating the chair as proxy, you have till 10am on Monday to lodge your request. You can do this online with Computershare. Your papers should have arrived ages ago. Have you nominated to get online notifications? If yes, check your spam folder. If you are voting in person at the AGM, well, you have to be there.
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Frogster
Posted on: Nov 9 2019, 03:01 PM


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Johnny, thanks for highlighting some details of record from those FDA papers. It may not make for edifying reading, and I'm sure we'd all rather believe the whole application was flawless and perfect, but I for one would rather the facts are out there minus any spin. What we all choose to do with that information, how we interpret it's importance historically and how relevant it is going forward, is obviously down to the individual and their own approach to investing, risk management and trust. May we all come to conclusions that we are all comfortable with in the long term.

LJS, The Corporation Act requires a listed company to have an AGM for it's members. Members are those who own shares. A company is under no obligation to allow members of the public into an AGM, though many may choose to do do as a policy. ADR holders do not own shares, therefore they are not members and have no automatic right of entry. They could be allowed entry as guests, but that is at the sole discretion of management. Validly appointed proxies are allowed to attend the AGM on behalf of members, but those are the only people, other than members, that CUV is required to let in the room.
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Frogster
Posted on: Nov 6 2019, 04:34 PM


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I'm not sure if it's the last date to update the detail of Resolution 4 before the AGM, but what I do know is that AGM resolutions can be withdrawn right up to the point they are voted on. Please see the attached document which confirms this on page 5. The Board is not bound to hold a vote on Resolution 4 as it currently stands at the AGM.

For anyone who thinks Resolution 4 is flawed, as I do, you have the option to suggest to the Board that it is withdrawn, reconsidered and voted on at a later date under an EGM. I have done this via the IR submission form on the Clinuvel website. This appears to be the favoured method the company has to accept investor contact. We must assume management will fulfill their obligation to pass such comments to the Board.

Withdrawing, redrafting and resubmitting Resolution 4 would be a better outcome than seeing it voted down given the numerous questions, omissions and apparent largesse in some terms that at least some of us are concerned about.

Attached File(s)
Attached File  guidelines_for_notices_of_meeting.pdf ( 76.12K ) Number of downloads: 52

 
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Frogster
Posted on: Oct 30 2019, 05:49 PM


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I agree with several of your points, but I don't see there is any overall benefit in their misremembering/misrepresentation of observable history.
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Frogster
Posted on: Oct 30 2019, 04:26 PM


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From today's TGA press release:


“The submission of the scientific data on SCENESSE® to the TGA was always planned to occur after obtaining European and US approval,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said.


This is a great example of the kind of behaviour from CUV which really annoys me. They are trying to rewrite history in a way that favours themselves. That statement is inaccurate.

The 2017 AGM presentation, p40, showed an anticipated TGA filing late Q3/early Q4 2018. p42 shows, at that stage, the FDA PDUFA date was expected to be Q1 2019, so clearly at some stage it was anticipated TGA submission would run in parallel with ongoing FDA consideration and NOT wait until US approval was given.

Timings change, and strategies change. I get that and don't have major issues with many of the reasons which cause delays. I'm not holding them to those particular dates, but please don't take us for mugs and claim you always planned it this way. You didn't, and any claim otherwise can only be seen as self-serving. Lodging with the TGA next year will trigger a performance clause in the Rights package they are seeking approval for, as would subsequent approval. If they'd filed on previously disclosed time frames, no such triggers would've been made. So, to me, a little more honesty and accuracy is in order since a big pay packet is linked to these claims.

I think the management has achieved something really great with FDA approval, and there is a bright future ahead for the company. PW in particular has already been handsomely rewarded for his efforts. I have no doubt PW and Management deserve to be rewarded well for any further significant progress, but I guess my view of "well" differs a bit from that of the Board. Also, some of the terms in the Performance Conditions, on reflection, are so loose you could drive a bus through them.

PW extolls the virtues of situational awareness. I'd encourage the company to develop a little more self awareness too. That means being happy, and even proud, to have achieved what they have, but please do not try and claim perfect execution and strategic vision and please recognise when your execution has varied from what you have presented to us.
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Frogster
Posted on: Oct 30 2019, 11:16 AM


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That would've been more helpful if he'd explained why the recession clauses are so soft. 9% outperformance of an index wouldn't even rate as a Strong Buy at most investment houses, and yet it would see full payout, with the choice of 2 indexes as the baseline!
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Frogster
Posted on: Oct 26 2019, 08:53 AM


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I think there are hints in the AGM papers that in their minds a Nasdaq listing is still very much on the cards, even if it isn't explicitly stated.

There are several peculiar things about the PC1 "recession" clauses, not least the following:

"Only in the case of a recession in the country of the Company's primary market exchange....." It's obvious, isn't it, where the primary market exchange is? It's Australia. If the listing status quo was certain to be maintained for the foreseeable, why write a clause that provides flexibility to move away from the current status if that was not a possibility being considered?

Also

"The Company's growth in share price outperforms either the Nasdaq Biotech Index or ASX Healthcare Index......" So, this statement is a s clear as mud. They've mixed absolute performance metrics with relative ones, and provided themselves with a choice of indexes to outperform, one reference priced in A$ and the other in US$. They may have done this to make it even easier to achieve the clause thanks to currency movements, or they may have done this to automatically switch the reference index should the "primary market exchange" change to one where that has a different reference currency. You can take your pick as to which is most likely.

Of course, they could clear this kind of rubbish up very easily if they chose to engage with valid questions and not assume their lawyers and consultants have covered every issue beyond query.


On the issue of questions for management, a couple of points that may be of use to shareholders who cannot physically attend the meeting. In the 2019 Corporate Governance statement where the company states it complies with principle 6.3 it states:


6.3 Comply

A listed entity should disclose the policies and processes it has in place to facilitate and encourage participation at meetings of security holders.

The Company encourages full participation of shareholders at the AGM to ensure a high level of accountability and discussion of the Company’s strategy and goals. The AGM exists, among other things, to promote shareholder communication by providing shareholders an opportunity to ask questions to Directors at the time of meeting. Directors are expected to make themselves available to meet with shareholders at the AGM. The external audit firm partner in charge of the Company audit is available to answer shareholder questions at the AGM. Shareholders who are unable to attend the AGM or other general meeting may submit questions and comments before the meeting to the Company or the external auditor (in the event of an AGM). Also, shareholders are permitted by the Company to vote online and by other methods prior to the AGM if they are unable to attend.

I can't find any instruction at all in the AGM voting papers as to how shareholders who can't attend should actually submit any questions they may have, but I suppose you could use the submission form on the website. I'm sure those who attend the meeting will report back privately if your questions were asked, and also what the answer was. It's interesting that the principle CUV says it's complying with encourages participation of security holders - not shareholders. I wonder if, from a technical perspective, if CLVLY and UR9 are securities or shares?


Finally, for those questions of how to cast your vote, if IR isn't helping you out much, I note that the final point on the AGM paper is:

h) If you have any queries on how to cast your votes call Darren Keamy on (03) 9660 4900 during business hours.

That might be worth a shot.
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Frogster
Posted on: Oct 25 2019, 05:39 PM


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http://www5.nohold.net/Computershare/ukp.a...mp;cpage=vagent
Maybe try the online form and process suggested on this page. It's Computershare UK based advice, but since I don't know how and where you hold your shares it might just work (and, it might not!).
Good luck getting some representation on your investment. I sometimes think they momentarily forget they're a publicly listed company.
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Frogster
Posted on: Oct 24 2019, 11:12 AM


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I'm pretty sure the ADR agreement says the shares held by BNYM on your behalf will not be voted unless you have directed your vote. Of course for that to happen, CUV has to ask BNYM to enquire what your voting intention is.
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Frogster
Posted on: Oct 19 2019, 02:58 PM


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I like the A$7.5bn mkt cap incentivisation bit. It's a demanding hurdle, but gets well rewarded. Multiply the shares price approximately 5 fold from current levels? Sounds good to me.

What I'm not so keen on is what the targets become if we have a recession, and lets face it that's quite possible in the next few years. Under those circumstances, he gets the same reward (number of shares) by outperforming a biotech index by a bit (only 9%!!!), over a calendar quarter. Whats very unclear is what happens if there is a recession which we come out of quickly. Does the switch to the "outperformance" metric stick, or do the targets switch back to mkt cap based ones? Let's say a recession hits in the next 6 months, but immediately thereafter we exit it. If the metrics do not switch back, then essentially there's 3 years left to outperform a bio index for just one quarter. These metrics seem very weak by comparison to the mkt cap. ones.

The other thing that's a bit unclear is where they say they intend to introduce a similar rights scheme for managers. Presumably that's CFO, CSO, LH and maybe others. It's possible to read what they've said as implying the same quantum of shares will be issued as for PW. So, does this bit mean they intend to issue ANOTHER 1.5m shares to non board level management as well?

"Following the Meeting and subject to Shareholder approval of Resolution 4, the Board intends to grant senior management Performance Rights under the Performance Rights Plan as a means to provide further incentivisation for their commitment to the Company’s commercial development under Dr Philippe Wolgen’s management direction. These Performance Rights will have similar or equal Performance Conditions to those attached to the Performance Rights to be granted to Dr Philippe Wolgen upon approval of this Resolutions, to align the interests of senior management with those of shareholders"

I'd like to understand how many shares might apply to this bit, cause 1.5m seems quite a few to me!
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Frogster
Posted on: Oct 18 2019, 11:59 AM


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I agree. That bit is quite a soft touch.
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Frogster
Posted on: Oct 18 2019, 10:47 AM


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AGM papers show a proposal to issue up to 1,513,750 performance rights to PW with a 4 year expiry date.

Hurdles to get maximum issuance include:

-Market Cap above A$7.5bn for at least 15 trading days
-A$150m in cash and equivalents held on the BS
-Launch of OTC VALLAURIX product
-Submission AND approval of another pharmaceutical product

There are plenty layers and grades of how much he gets for what, but the terms appear at first glance to be much more mature than those applied to the last rights plan. The biggest incentive, at approximately twice the size of the next biggest, is the Market Capitalisation/outperformance metric. That should please some of us on here.

At approx A$46.5m worth at current share price, how close does that get him to that football team?
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Frogster
Posted on: Oct 17 2019, 11:17 AM


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I'd say it will be within the coming weeks.
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Frogster
Posted on: Oct 14 2019, 07:23 AM


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Personally, I'm not expecting their communications approach to change very much. I think they'll remain happy to communicate strategies in broad strokes - and it's an exciting strategy - but will continue to be light on making the detail public and very light on the opportunities to be questioned on those details as and when things vary from the broad stroke guidelines. Maybe the frequency of presenting those the strategies will increase (i.e. more investor conferences) but I'd be surprised if the content style changed much. They are great at stonewalling answers to questions, written and verbal, so simply doing more presentations doesn't equate to sharing more detail.

The company has achieved a tremendous milestone with FDA approval. They really have and I congratulate them for this, especially for their determination to get there, but the fact that extreme caution in communication was demonstrated by the way they ran the conference call. The approach of picking which questions they would respond to (the responses we're always answers in my opinion) smacked of this. They didn't need to do this. There were loads more questions that they just ignored.

I think it's simply the case that the cautious approach is their M.O. I can't see why PW would change this. He has never "pumped up the tyres" of any indication, and I don't think he ever will. I'm sure we'll get updated with milestones as they get ticked off - whether on time or delayed - but PW will never hype things. Having come to this realisation, I think I'd worry if he ever did. He's going to leave hyping things up to the likes of us.

Having crossed the threshold of FDA approval, I consider we're moving into a phase of exciting developments which have huge and lasting growth potential. I intend to hold my shares for a while yet, but I have little doubt that aspects of the "Clinuvel way" will continue to annoy the hell out of me for a long time to come, but I hope this will be tempered by what the growth does to the stock price. If they'd hired many proven, experienced operators to get us through the FDA quicker and run the paused programs in parallel I wonder what that'd have cost in total? Would that have left us in debt? Would they have diluted us significantly?

Without a change in management, I don't think there'll be change in management approach. That is, paint broad strategic strokes, keep the details close to your chest, manage cost conservatively and ensure a tension with shareholders by keeping relationships at arms length balanced by avoiding dilution and delivering earnings growth. Over the years that approach has worked for us, and may it continue to do so.
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Frogster
Posted on: Oct 12 2019, 06:42 AM


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Now that the FDA has accepted Scenesse essentially enables 6 hour pain free sun exposure and that it has established a good real world safety profile, I wonder if CUV will (or even can) go back to the EMA to formally update that approval with the more appropriate efficacy analysis and to remove the "exceptional circumstances" tag. It might be expected that formally accepting the efficacy data which the FDA has would significantly ease and extend further European rollout. On the other hand, will CUV simply leave peer group pressure to do its thing and continue operating with the limitations of the EMA approval status quo?
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Frogster
Posted on: Oct 11 2019, 02:07 PM


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Any more takers for the Melbourne get together next Thursday? Let me know.
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Frogster
Posted on: Oct 10 2019, 06:14 PM


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Good find.


It looks like FB Rice is just providing the location, with the event having been organised by Monsoon Communications. They were mentioned as the media agency covering Australia in the media (as opposed to the Asx) release yesterday.


CUV is beginning to market itself

On that issue a friend of mine recently bought some CUV through his broker, Shaws. His broker knew not too much about the company, but he expected a whole pile of extra coverage following our second major regional approval. Providing at least some access to management for brokers and analysts will be key to that. Not many investment houses will take the Sphene approach of in depth coverage despite no access to executives. Twilight Briefings and the like should be very helpful to us in that regard.
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Frogster
Posted on: Oct 10 2019, 11:09 AM


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I think the chances of this have increased dramatically since yesterday. Given how tightly the shares are held, and how diverse and dilute the shareholder base, I can only imagine it getting up at a "good" price for current holders. I wouldn't actually be surprised if the "odd" trading ahead of approval was some mechanism of quietly building a stake. It will be interesting to observe from here on.
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Frogster
Posted on: Oct 10 2019, 07:08 AM


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With the stream of posts on here since yesterday, I thought I'd repost the suggestion of a Melbourne get together next week lest it gets lost in the mix. I'll likely do the same again tomorrow before deciding the format and booking as appropriate.

So far we're looking at a nice dinner with board members whose characters come across as erudite, provocative, challenging, intellectual, informed, humorous and sophisticated. I only hope the face to face reality lives up to such expectations.


**********
Wow, what a night. What a day.
It's been a long haul to get here, with fun and frustrations along the way.

I'd be keen to have a drink with any of you who would like to mark this milestone.

So, next Thursday (I think we're all too frazzled to do tonight!), 17/10 around 6.30pm somewhere in the Melbourne CBD for drinks/bar snacks or drinks/dinner, depending on numbers.

If you're interested, let me know via private message ASAP and we can work out the details from there.
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Frogster
Posted on: Oct 9 2019, 04:13 PM


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Nor mine.

Don't like that "selected questions only" approach.
Despite that, today was still a good day.
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Frogster
Posted on: Oct 9 2019, 12:38 PM


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Wow, what a night. What a day.

It's been a long haul to get here, with fun and frustrations along the way.

I'd be keen to have a drink with any of you who would like to mark this milestone.

So, next Thursday (I think we're all too frazzled to do tonight!), 17/10 around 6.30pm somewhere in the Melbourne CBD for drinks/bar snacks or drinks/dinner, depending on numbers.

If you're interested, let me know via private message ASAP and we can work out the details from there.
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Frogster
Posted on: Oct 9 2019, 08:59 AM


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Where's punkassderm? He should be joining in with the celebrations!

Whilst I'm very happy for us all financially, I'm just loving reading the joyous comments from patients on the social sites. I don't mind admitting some have moistened my eyes. We're (very) happy, but their lives are about to be transformed.
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Frogster
Posted on: Oct 9 2019, 03:27 AM


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What super news for patients, the company and us.

It's been a long road to get here, but what an achievement.

I think I may try to get some sleep now. Would it be wrong to open a bottle of fizz with my breakfast All Bran in a few hours time?
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Frogster
Posted on: Oct 1 2019, 09:07 PM


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Here's a little detail on the recent launch in Denmark:


https://www.tv2fyn.dk/artikel/nu-kan-han-ta...ynsk-behandling


The doc calls Scenesse “groundbreaking” and “life altering” for the patients.

73 EPP sufferers in Denmark. 3-40 are eligible for treatment (probably the proportion who are adults).

100,000 DKr per implant = 15,500 USD. 4 implants per year.

Joachim says it has changed his life dramatically.
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Frogster
Posted on: Oct 1 2019, 10:09 AM


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Remember that the FDA can still be late in its response without another formal delay being invoked.
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Frogster
Posted on: Sep 27 2019, 06:40 PM


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Billy, what will you complain about if we get approval next week?


We all know it's been a long road, we all know some missteps may have occurred, we all know PW gets very well paid. I'm sure obsessing about volatility at this stage won't help any.


Maybe chill a little and come back in a few weeks and check if there's something to really complain about, or maybe even to celebrate.
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Frogster
Posted on: Sep 23 2019, 10:43 AM


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She will resign and stand for re-election at the upcoming AGM. You'll be able to vote on her appointment then.

Oh. Hold on.....
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Frogster
Posted on: Sep 13 2019, 02:57 PM


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Has anyone seen any detail from the safety and effectiveness data that was presented this week at the ICPP? I can't find it.

Announcing via press release it's being presented is all well and good, but I'd also quite like to know what the data actually shows.
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Frogster
Posted on: Sep 11 2019, 05:32 PM


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Hold on......you didn't mention the takeover????!!?
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Frogster
Posted on: Sep 11 2019, 05:24 PM


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So is the William Wallace character (Mel Gibson) representative of PW? Maybe he's a bit short to properly represent WW, but then so was Gibson.
Who, then, is Stan? What about LH? Would DK be on the front line, or at the back sharpening swords?

And who are the attackers? Angry, upset, nervous shareholders? The FDA? Maybe NICE (since they're supposed to be English). Maybe they're the shorters, or even the long awaited corporate interest that X ray reminds us of from time to time.

Whatever the case, WW and Scotland shone bright for a while, but he met a rather nasty end. As for Scotland, it made it's own unique way in the world for a while, only to be subsumed by a richer, larger competitor. At least, again, for a while. Perhaps that'll change again after 31 October.
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Frogster
Posted on: Sep 10 2019, 07:52 AM


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The slide posted by Sharelooker, according to the BPA twitter feed, came from a presentation delivered by Dr Rocco Falchetto.

As we know, he co-founded the International Porphyria Patient Network (IPPN) with Dr Jasmin Barman-Aksozen and that slide looks to me as if its come from a presentation on Sunday 8, probably "The Power of the Patients voice" or "The Empowerment of the Patient". My read is that he is about to explain why/how/when the IPPN was formed. He's not saying there "is" still confusion, but rather, there "has been" confusion.

Those themes are very close to the content of a great article posted on here by Seeva back in early August, written by Dr J B-A in which she discusses why/how/when they formed the IPPN:

https://journals.sagepub.com/doi/10.1177/23...eShareContainer

So, my guess is that the rest of his presentation would've hit upon the main points made in this article i.e. clumsily applied statistics can't always tell the full story, and patient experience is a critical part of any sensible assessment. Another way to put it might be that the presentation looks like it's probably a slide interpretation of the paper.

Read the paper if you haven't already - it's quite interesting.
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Frogster
Posted on: Sep 3 2019, 03:52 PM


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A Director buying a few ADRs? That can't be a bad sign at this stage of the process.


Attached File(s)
Attached File  3A523337_CUV.pdf ( 182.85K ) Number of downloads: 291

 
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Frogster
Posted on: Aug 30 2019, 08:45 AM


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I have no problem with management interests being aligned with shareholders. Indeed, like you, I very much want them to be. However, for me, the detail of how it's brought about and its extent is what matters. We don't yet know the detail of what is being offered to CEO/CFO this time round, so I think it's premature to take a final view on things, but what I'd say from previous experience with their schemes is this:

- any rights schedule should have timelines associated with it. Last time there were no expiry dates. We know how dreadful CUV is at hitting it's own delivery schedule. Sometimes this may be out of their hands, other times not. Whichever is the case, they simply need to accelerate their delivery and stop with their excuses and avoidance of responsibility.

- any performance hurdles need to be real challenges. Last time the 1st Performance Condition was that the rights plan be approved - a somewhat circular achievement! The 4th Condition was the submission of the NDA - not it's approval, but the submission. I don't mind paying up for good outcomes, but I'm less inclined to be so generous for following process.

To me, it should be a matrix of reward. Perform your job, and not especially quickly, you don't get any great bonus. Deliver a stellar outcome, and quickly, get rewarded handsomely.

What's different this time round is Blijdorp is Chair of the Remuneration Committee. He wasn't on the Board in 2014, and had no role in the last big rights package. His view that management should have up to 20% equity is, for me, too high for a company not founded by current management, but I'd be OK at up to 10% or so (with appropriate hurdles to get there). What I do very much like is his view that the Board should NOT be involved in Rights schemes. To me this is how it should be. The current Board has been way too cosy with management, and they shelter themselves from scrutiny by disenfranchising major groups of shareholders. 2 board members have been there for over 10 years - no longer independent by their own measures, and the most recent addition smacks of historical fondness rather than proven board ability. Moving to a more "arms length" approach is to be welcomed, and I'm hopeful that terms associated with the next Rights scheme will be similarly more appropriate.

So, I'm willing to wait to see the details before taking a view, but no doubt I'll remain very skeptical that the delay in negotiating new terms is down to the executives being busy as opposed to driving the AGM vote into the nice warm window we'll all experience if the FDA says yes. I can't imagine a big, generous rights package getting up if the FDA says no!
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Frogster
Posted on: Aug 28 2019, 06:21 PM


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Posts: 692

I don't think you should assume a NASDAQ listing is off the cards. Indeed, the CFO didn't trigger his cash BGI for either a listing or expansion through acquisition before 30/06/19, so those incentives have lapsed. However, both he and PW are (still) in contract negotiations.

As per Blijdorp on p13, the new agreements are with the lawyers for review right now. He states that a goal of them is to reduce short term incentives and business generating incentives settled in cash, and replace these with shares via conditional rights. I'm pretty confident these new employment terms will include share based incentives for a listing and acquisition, and, for PW an addition of other metrics.

Given Blijdorp has reiterated his view that he likes management to have up to 20% of a company, we can assume the equity on offer to management will be quite significant in magnitude. Presumably there will be a vote on the proposed scheme at the 2019 AGM which will be held shortly after a hopeful FDA approval.

Sounds to me like a pattern similar to the EMA approval which was very shortly followed by a vote on the generous 2014 Performance Rights Plan. A cynic might assume some linkage between the delay in the new employment terms and the delay in the PDUFA date, and not simply that the executives have been quite busy.
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Frogster
Posted on: Aug 20 2019, 09:25 AM


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Newsletter out.


No further delay anticipated, though not guaranteed.
Reminder, yet again, to expect similar pharmacovigilance in US and EU.
Intention to distribute by themselves in the US.
Might increase IR function.

Thin on detail, as you'd expect. Only a few foreign language references. Hand holding exercise.
Attached File(s)
Attached File  447mmgqw64f8kv.pdf ( 424.23K ) Number of downloads: 133
Attached File  447mmgqw64f8kv.pdf ( 424.23K ) Number of downloads: 47

 
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Frogster
Posted on: Aug 18 2019, 09:43 PM


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I don't disagree that Fda approval would be of seismic magnitude, but I do think that if there are ambitions to be a broad based company, simultaneous progress on parallel fronts is not an unreasonable thing to expect. I just hope they been doing something in this vein and not (yet) telling us about it.
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Frogster
Posted on: Aug 18 2019, 09:05 PM


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Agreed. There is So MUCH stuff that has gone dark since the Fda application delays/extensions that we might hope for a whole raft of newsflow after any approval.

Regarding VP, that was due to start European spring, with 6 or 8 month follow up (can't remember the precise detail) so that should be ongoing.

There should have been another indication announced early this year. What's going on with paediatric scenesse? Where are the oft referred acquisitions....... Etc etc.

I get that some stuff strategically relies upon fda approval. I'm not sure I get why everything seems to be waiting for it.
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Frogster
Posted on: Aug 16 2019, 04:16 PM


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We're not (yet) listed on the agenda for the August meeting. No meeting due in September AFAIK.
Ho hum. Twiddle twiddle. More hurry up and wait.
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Frogster
Posted on: Aug 7 2019, 01:26 AM


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Double post delete.
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Frogster
Posted on: Aug 7 2019, 01:26 AM


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There's no doubt that in the last few days the big market trade has been to take risk off the table. This approach make last a while, or it may reverse tomorrow. Who knows?

What there is also no doubt of is that should the FDA give us the go ahead then that will be the the biggest single derisking event CUV will ever likely see. It'll be far bigger than the European approval since it'll open the door to a bigger, single market place. As seeva referenced the other day, it'll also unlock the door to the much bigger opportunities that lie beyond EPP and, for most of us, that's probably what got us involved in the first place.

We're an odd beast. Low risk versus typical biotech (EU approval, sales, profitable, cash generative, no debt, first in class therapy) but high growth versus typical mature pharma business (huge potential for geographic expansion, line extensions, multiple orphan applications).

Should the approval go ahead, for me that will mark the transition from mature biotech to junior pharma. Whether the market is seeking growth or stability over the next fews, if the Fda approves, I think CUV will remain a great place to be.
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Frogster
Posted on: Aug 1 2019, 04:31 PM


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Thanks so very much for sharing these docs Johnny H. Very valuable primary research which you've been kind enough to let us all benefit from. Big thumbs up.
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Frogster
Posted on: Jul 31 2019, 09:36 AM


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The quarter was slightly below my modeling (13.5m vs 13.01m), but up 25% yoy for the quarter is still pretty damn good in my opinion.

Cash at year end was 0.2m below what I was expecting, but when you see that Product manufacturing and operating costs were over 0.4m more than the last guidance and that this is a leading indicator, then I'm fine with it.

For the next quarter, they're expecting to maintain high PM&OCs - above 2m only for the second time - and that advertising and marketing costs will nearly triple from the just reported period.

Sounds like they're expecting something significant to happen soon.
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Frogster
Posted on: Jul 16 2019, 02:22 PM


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Guesses? GUESSES?!?

I'm at A$13.5m for the quarter, 30% growth YoY, and cash at quarter end of A$54.475m.
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Frogster
Posted on: Jul 4 2019, 03:58 PM


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Agenda for NICE HSTEC meeting on 25/7 is available. We're not on in.

https://www.nice.org.uk/event/hstec-july-2019

The next meeting is 29/8.
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Frogster
Posted on: Jun 21 2019, 04:13 PM


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We're now an ASX200 stock.
Respect to PW, his team and all long-term investors.
Now, let's see the fundamentals delivered, please.
  Forum: By Share Code

Frogster
Posted on: Jun 19 2019, 03:41 PM


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Get Giles Delaney to do it.
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Frogster
Posted on: Jun 18 2019, 02:10 PM


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You have a job???
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Frogster
Posted on: Jun 18 2019, 01:51 PM


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Just for kicks I thought I'd have a look at the trading volume of recent additions to the ASX200 between the date their addition is announced, and the last trading day before inclusion.

I looked at the last 5 additions, Cooper Energy, NRW Holdings, Nearmap, Hub24 and Pinnacle Investments. Most of them had 6 trading days from the announcement till the actual inclusion, but NRW had 8. There is a VERY strong pattern that the last day before inclusion is by far the strongest volume day.

If you calculate the daily percentage of the total traded between announcement and inclusion, you get:

Cooper: 4%, 8%, 8%, 8%, 10%, 62% i.e. 62% traded on the last day before inclusion, which is 8.3x the average of the other days
NRW: 8%, 14%, 7%, 8%,8%, 5%, 4%, 46%. Last day 6.1x average of other days
Nearmap: 10%, 20%, 16%, 10%, 8%, 36%. Last day 2.8x average of other days
Hub24: 6%, 10%, 11%, 9%, 10%, 54%. Last day 5.9x average of other days
Pinnacle: 6%, 7%, 8%, 11%, 10%, 59%. Last day 7.2x average of other days

Therefore the AVERAGE final day trading volume multiple on these 5 recent examples is 6.0x.

In the 2 full days of trading since the announcement that we are in, there was an average volume of 252,509 CUV shares traded (ANZ data). If the average final day multiple applies to us, then on Friday we could see a volume of 252,509*6 shares traded. That's 1,515,054 shares.

Wowzers. The current TOTAL offered shares are 32,100.
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Frogster
Posted on: Jun 16 2019, 11:51 AM


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It doesn't seem unreasonable to me to forecast well above A$0.50 EPS in short order if we get a positive FDA and NICE response.
We had a fully diluted EPS of A$0.267 in 17-18 at the very early stages of European roll out. It depends how far down the track you want to look, but if you judge that at least some of the development goals will be reached, there is still a phenomenal potential growth story here in my opinion.
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Frogster
Posted on: Jun 16 2019, 09:36 AM


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Did you look at the forward p/e too? How might they compare?
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Frogster
Posted on: Jun 9 2019, 05:22 PM


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He doesn't seem to know very much about the detail of what Clinuvel does/intends to do.
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Frogster
Posted on: Jun 4 2019, 03:07 PM


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Posts: 692

If that situation occurs, my thoughts would be to look at the available evidence and try to match that against published procedures to understand what had happened. Sure, I'd be pissed off, but I'd try and get to the why, not just wail about the what.

Don't confuse my position with me being comfortable, or even happy, that the process is taking so long. Far from it. I think aspects of Clinuvel's approach has been naive and inefficient, but I'm not seeing anything that suggests the FDA is twisting it's own procedures in order to defeat CUV. Whilst CUV itself isn't always forthcoming with detail, through lots of digging done through this board, plausible explanations have usually been found for delays.

PW has often stated that the dossier is a challenging one due to the innovative offering, the product history and ineffective scientific tools to prove efficacy. I'm less inclined to believe that the bogeyman is behind the various delays than I am to believe that what they're trying to do is really hard and they've made some errors along the way.
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Frogster
Posted on: Jun 4 2019, 01:36 PM


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Clinuvel stated yesterday, in black and white, that the Fda needs more time to study data provided by Clinuvel in the review period. That means data provided after the NDA was lodged. Ergo, the NDA was lacking in some way.

As proven by the document I linked to, extending the Pdufa date is perfectly consistent with a Major Amendment being accepted in an attempt to offset a Significant Deficiency (fda terms, not mine).

Has Clinuvel been incompetent? Perhaps, but then again the list of companies included in share lookers list of other companies with Pdufa extensions includes some very experienced broad based companies. Are they incompetent too? Perhaps, or maybe the fda is a high hurdle to pass.

Regarding patiently waiting, what else can cuv do? They've submitted more data post lodgement. The fda needs extra time to review it since it wasn't in the initial package, and they've applied the standard 3 month extension as per other companies. Cuv has laterly submitted what they think is required I. E. fixed the problem, and now, again, they wait. It's not finger pointing, they're describing the process. Regarding "finite resources", that's a truism. More hands, lighter work. It doesn't mean cuv thinks the fda is twiddling it's thumbs. Many times they've referred to the many fda demands. Cuv knows how finite resources can constrain achievements, just look at how slow our progress has been. I can see how it's possible to interpret the comments as fda shaming, but I don't think that's the right interpretation. As you say, why would they? In my view they are not doing that, they are simply, but clumsily, stating process facts.
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Frogster
Posted on: Jun 4 2019, 10:46 AM


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As with everyone else here, to see this extension is very frustrating. I've tried to step through the process to understand what as happened, and this is what I've come up with. Lots of speculation on my part, but nothing new in speculating on CUV! It's probably not stating much entirely new, but maybe I'm laying it out in a different manner to previous posters (thanks to you all):

Firstly, here's a link to the FDA policy on communication of planned review timelines to applicants:

https://www.fda.gov/media/72710/download

Next, here's what Clinuvel has told us about its communications milestones:

-On 10/1/19 (NDA press release) they told us that labeling and post marketing requirements would be issued by 8/4/19
-On 2/5/19 (Newsletter) they told us with regard to the 8/4/19 deadline "no further news can be reported" and that "the FDA is simply focused on other issues in the review" and "in the coming weeks we may receive the awaited labeling questions". Note that Clinuvel did NOT say the date has passed with no communication, rather that nothing can be reported.

In the FDA document linked above, there's a section which mentions what will happen when "Significant Deficiencies preclude the discussion of Labeling or PMRs/PMCs". Basically it says if they find significant deficiencies in the application, they probably won't communicate about labeling in the target timeframe. They will then tell the applicant these deficiencies preclude the labeling discussion. What the applicant does is obviously up to them. If the applicant responds (with data, facts, arguments etc etc) the FDA will decide if the response constitutes a major or minor amendment, whether it will be reviewed during the review cycle and if it will change the PDUFA date.

So, I think the story goes like this:

-the FDA accepted the NDA from CUV.

-they found what amounted to a Significant Deficiency in the dossier, most likely in the CMC area (in the newsletter PW told us this area was taking up the "lions share" of attention, and it ties in with JHs good work).

-CUV submitted amendments to address these issues (from yesterday: "to allow time to evaluate data provided by CUV as part of the scientific exchange within the review process" and I think collating this has been mostly what PW has been referring to when he's spoken of the team working all hours). I think they were unaware at the time of the Newsletter whether these would be considered minor, major or even would be reviewed at all. I think this uncertainty might be why PW started talking about 50/50 chance of CRL at that stage - he didn't know if the amendment would be reviewed. As it turns out, the amendment has classified as a major one which will be reviewed, with the standard 3 month PDUFA extension which is a better time frame then the alternative of CRL with a possible consequent delat of 12m+ (as PW discussed).

So, to my mind the "issue" lay not with the FDA, but rather on CUV's side, quite possibly and more accurately with their manufacturer. Looking at the great work by Sharelooker, it's clear that a PDUFA extension is in no way an impenetrable barrier to approval, and indeed the opportunity to respond to a deficiency is better than not being able to. Most of the companies SL found use some or many phrases like "more time to respond", "major amendment", "standard 3 month extension" etc. etc., and it strikes me that the release from CUV yesterday, whilst really frustrating, in content isn't much out of line with other communications of a similar situation.

So, maddening as all hell to see another delay, but it seems to me we're no less likely to be approved than we were last week. In fact, we could be more likely since we've had the opportunity to address a Significant Deficiency without a CRL being issued.
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Frogster
Posted on: Jun 3 2019, 09:30 AM


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Posts: 692

Can't say this is a complete surprise. We've been here before. A quick google threw this up as a possible explanation of why (given that CUV, rather disappointingly, isn't telling us):


"But what about moving the PDUFA date itself? Yep, the FDA can and sometimes does move a PDUFA date, though it is relatively rare. The FDA has a piece on it in the Manual of Policies and Procedures – MAPP 6010.8. Unfortunately, it is not available in English, it is written in beaucratese. I will do my best to translate.

The FDA can move the PDUFA date when there is a "major amendment" made to an NDA which can be because the FDA has requested certain information (a solicited amendment) or because the sponsor of the compound submits an amendment because there is new data that has to go into the application, such as results from a study (an unsolicited amendment). In the case of Eisai, it was due to the former situation.

Examples that serve as the basis for a "major amendment" is information about (i) protocol deviations and the impact that they might have had on study outcomes; (ii) that provides clarification about a manufacturing site; (iii) data inadvertently left out of the final study report; (iv) there is new validation data and analyses; (v) updated data from a previously reported study.

Just because there is a major amendment doesn't mean that the PDUFA date will have to be extended, it just means that it can. If the major amendment is submitted early in the review cycle then the division overseeing the application may not choose to extend the date. If however, the information is submitted to the FDA within 90 days of the PDUFA date, then the original PDUFA date will be extended. "



http://eyeonfda.com/2010/08/when-does-fda-...d-a-pdufa-date/
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Frogster
Posted on: May 30 2019, 01:04 PM


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Posts: 692

At the beginning of this month Sharelooker found a NICE reference which suggested the results of the UK NICE HST re-appraisal (after the success of the appeal last year) was expected to be published in June.

We didn't manage to beat this expectation and make it onto the May HSTEC agenda, and their June meeting has now been cancelled (see below). The next meeting date is 25/7 therefore it looks like the newsflow order should now be:

-ASX200
-FDA
-NICE

Personally I'd rather see fundamentals lead the technicals, but I'll not complain about that if they all come in with a tick.

https://www.nice.org.uk/get-involved/meetin...ation-committee
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Frogster
Posted on: May 28 2019, 04:13 PM


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Posts: 692

Have we ever had 1m+ shares traded in a day?
That'll help the ASX200 liquidity calcs.
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Frogster
Posted on: May 16 2019, 05:40 PM


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Posts: 692

In the event of a merger, dealing with a very disparate number of shares in issue on either side of the transaction is a trivial matter. You'd just play around with conversion ratios to make sure that respective shareholders got the appropriate share of value in the new entity. If one party had a gazillion shares and the other 5, it wouldn't complicate a merger at all.
To your question can companies cooperate without merging, the answer is yes. Form a JV (ownership shared between the parties) and do the work through that. You probably wouldn't do that in this case though. The operations appear quite complementary, so if anything is to happen, I'd think an all in approach would be the most sensible.
Yay for the price action today. I'm a bit upset I missed watching it real time - but I'll get over that I'm sure.
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Frogster
Posted on: May 8 2019, 09:37 AM


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Posts: 692

Sounds to me like a securities lawyer had a close look at the signed ADR agreement and decided things hadn't quite been reported correctly in the past. By negotiation with ASIC, the situation has now been smoothed out via the relief process.

There's a little on that process and relevant circumstances here: https://asic.gov.au/about-asic/dealing-with...ply-for-relief/

I might imagine that having a securities lawyer look very closely at your existing listing arrangements might be a step in the process of investigating/instigating another listing elsewhere.

Housekeeping. Ducks in a row kinda thing.

Maybe.
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Frogster
Posted on: May 2 2019, 01:00 PM


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Posts: 692

https://www.clinuvel.com/social-media/subq/...he-drivers-seat

Not seen this one listed on here yet. I particularly like the way it links the thesis to Clinuvel and the pharmaceutical industry.
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Frogster
Posted on: May 2 2019, 11:30 AM


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Posts: 692

I think the language from PW is entirely appropriate at this stage.

From where we stand in the NDA there are essentially 2 possible outcomes: approval, or non-approval (CRL). 2 outcomes - a binary situation - and whilst not strictly accurate these could be considered as equally weighted outcomes with a 50/50 probability.

Think about the alternative. What if PW was publically stating that either outcome had a probability greater than 50%? Wouldn't that be placing a demand for a certain result on the FDA? Wouldn't that be telling them what to do? To me, that would be a complete no no. I do NOT want PW to be stating any kind of public expectation of what the FDA will decide. It would be entirely inappropriate.

We know that any approval essentially weighs the risk vs reward of a product. As per this newsletter you can re-write that as safety vs efficacy. On the basis of much detailed data that we are not privvy to we know that PW has made many statements expressing an opinion that Scenesse is both safe (PASS data) and effective (High continued usage).

His opinions here may be a very strong, but his job right now is only to convince the FDA his opinions correctly reflect the data and patient outcomes.
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Frogster
Posted on: Apr 26 2019, 10:04 PM


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The line where Wolgen suggested a link between Sphene and Homm - despite no proof - appears to have been dropped from the AFR website version of the article.
I wonder if there was a complaint and, if so, from whom.
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Frogster
Posted on: Apr 26 2019, 02:07 PM


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Wow. If PW doesn't like the pressure of an analyst suggesting $40 fair value, I wonder how he feels about the Chairman talking about becoming a company "an order of magnitude" larger than we currently are!
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Frogster
Posted on: Apr 24 2019, 06:37 PM


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I just had to say thanks to give you your 2000th. Nice work.
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Frogster
Posted on: Apr 24 2019, 02:04 PM


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Totally agree that it's wise to be very wary of "transformative" transactions. They are rife with the pitfalls you mention. However, "inorganic growth" could include licensing molecules, products or product lines. Inorganic growth can be small and manageable. It doesn't have to be hard to swallow. I think that's more PW style.
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Frogster
Posted on: Apr 20 2019, 03:20 PM


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If you aggregate the receipts from customers on a quarterly basis from Q1 12/13 until Q4 17/18 and calculate the proportion that each of these has been for total receipts, then Q1 has averaged 26% of RfC, Q2 21%, Q3 14% and Q4 39%. So, statistically Q3 has been on average the lowest quarter, and Q4 by far the strongest.

Each year can vary quite a bit from these averages due to timing factors, and of course there's a strong growth rate underlying all the data which makes for an imperfect analysis. I think we mostly thought Q2 in the current financial year was surprisingly weak. CUV reported this as being in part due to customers paying more quickly than in the corresponding prior period but they haven't explained if the same behaviour will repeat, or if it will likely have a positive or negative effect on the Q3 results.

FWIW I'm modelling that Q3 will be better than Q2 was, but in light of the timing factor question, my conviction is not strong on this.
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Frogster
Posted on: Apr 18 2019, 02:37 PM


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Safety is always a concern - indeed the primary concern - for any and every pharmaceutical product no matter how benign it may appear and no matter how long it's been used. There are many cases of drugs with a far longer history and wider use profile than Scenesse suddenly being found to have major issues.

Happily, the criticality of this is not lost on Dr W, not will it ever be by the FDA, EMA or any other agency.

I have no reason to think that Scenesse is anything other than a very safe drug, but if you truly believe that safety is a non issue and not even worthy of consideration, then I think you're deluding yourself.
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Frogster
Posted on: Mar 22 2019, 12:31 PM


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I think I may have stumbled across your form/forum. Doesn't seem to be live on the main website. And, sadly, it is a form.
https://www.clinuvel.com/about-clinuvel/inv...ns-contact-form

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Frogster
Posted on: Mar 20 2019, 07:50 PM


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Nothings gonna stop us now.
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Frogster
Posted on: Mar 20 2019, 07:07 PM


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Posts: 692

I said the other day that I didn't think the source of any shares would be PW selling off his recent issue due to the fact that these shares are commonly locked up for a period which I suggested might be 6 or 12 months. I also suggested the factual detail might be out there if anyone could be bothered to look for it.

Today, I thought I might bother to look for it.

According to the 2014 AGM notes where the recently completed Performance Rights Plan was approved, and describing shares issued under that plan:


"Any Shares issued under the Plan upon vesting and exercise of a Performance Right will rank equally in all respects with other
Shares for the time being on issue except as regards any rights attaching to such Shares by reference to a record date prior to the
date of their issue. The Company will apply for quotation of Shares issued under the Plan. However, the Shares will be subject to
the following transfer restrictions, and may not be traded on ASX while those transfer restrictions apply:

• A participant is not entitled to trade in any Shares issued under the Plan without the prior written consent of the Board until
the earlier to occur of:

a) 7 years after the date of grant of the Performance Rights;
b) the date on which the participant ceases to be employed by the Company or any of its subsidiaries; or
c) such other date as the Board determines.

• The Company may implement any other procedures it considers appropriate to restrict a participant from trading in Shares
issued under the Performance Rights Plan in accordance with these transfer restrictions."

So, it's clear that any recent selling was not from PWs recent issuance. Perhaps it could be from much earlier share award schemes (again, if you're keen to know, you can likely look it up!) but my feeling is that today's move was just technical in nature.

Tree shake, headfake, retrace - any or all of these. Not driven by fundamantals, or anything in the newsletter IMHO.
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Frogster
Posted on: Mar 20 2019, 01:42 PM


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Well, at least the volume today will bolster the chances of ASX200 inclusion next time round.
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Frogster
Posted on: Mar 19 2019, 01:09 PM


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....and of long-termers.
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Frogster
Posted on: Mar 19 2019, 12:39 PM


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Posts: 692

If only the 50% CGT discount was cumulative for each and every 12m holding period and not just the first.
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Frogster
Posted on: Mar 18 2019, 09:01 AM


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Couldn't see this "extra" volume over the weekend, and can't see it today either. Can anybody else? Do we know if the "extra" 700k changed hands or not?
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Frogster
Posted on: Mar 15 2019, 04:18 PM


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Posts: 692

Shares issued to management would usually have a lockup period of maybe 6 - 12 months. I haven't checked if this is the case with the cuv award scheme, but the detail is probably out there if you can be bothered to look. Personally, I therefore seriously doubt the seller here is PW with his new shares. I suppose it theoretically could be with he previously issued shares, but personally I doubt it very much. Given he has inside info regarding the Fda application he's probably prohibited from selling right now anyway. I guess we'll see when/if a change in significant holder notice is published.

My guess is fido or lagoda lightening up. The great news is that someone is on the other side of that sale and in size.

We hit an ATH of 29.99 today, on the biggest trading day by value in our history.

Its the end of a warm Friday afternoon here is Aus. I'm celebrating.
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Frogster
Posted on: Mar 15 2019, 03:04 PM


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What a day - and not yet over. Interesting aftermarket shenanigans.
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Frogster
Posted on: Mar 14 2019, 07:22 AM


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I think you'll find those shares are the newly issued board incentive shares which have now been created since the nda has been accepted by the fda. No money has changed hands.
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Frogster
Posted on: Mar 8 2019, 08:10 AM


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Diary note made for 14 June.
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Frogster
Posted on: Mar 6 2019, 04:36 PM


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Thanks for the namecheck, but I must say this site has been invaluable thanks to the efforts of many and varied posters over a long period of time. Long may that continue. It feels a bit like an extended family get together in here sometimes. Some you really want to talk to and share news with, some you really want to listen to for their wisdom, some you respect their attendance, are happy to say hi to, but that's enough contact till the next event, some are off their meds and some are off their meds and drunk.


Moving on....

We're hoping for ASX200 inclusion to be announced on Friday. Touching on the post from Johnny H the other day, I was wondering how we're travelling in price and volume terms when compared to the ASX300 announcement, so I added the numbers up (I think this includes both ASX and Chi-x data, though I'm not 100% on that).


ASX300 inclusion was announced on 7/9, with the index changes taking effect on 24/9

In the 10 trading days prior to and including the announcement the shares went up 27%, 784,268 changed hands at a daily average volume of 78,427.
In the 10 trading days after the announcement but before inclusion the shares went up 23%, but with nearly double the volume at 1,492,400 (149,240 daily average).
In the 10 trading days including and after index changes took place the shares rose another 16%, and total volume was 1,412,577 (141,258 daily average).

Assuming a positive annoucement on Friday, we've just seen the close of day 8 in the first block of 10. In that period the shares have risen 19% with a total volume of 904,285, giving a daily average of 113,036.

Since the move into the ASX200 is a bigger deal than the move into the ASX300 I'd guess that more traders might try to trade the inclusion. That might explain the near 50% increase in daily volume so far "this time round". Looking forward, given that more index funds track the ASX200 than the ASX300 and that more active funds will be able to invest due to mandate restriction, if we're included announced come Friday, I wonder if we'll see an even bigger (i.e. more than double) volume impact over the coming months.

Whatever happens, I guess we'll be watching with interest.
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Frogster
Posted on: Mar 4 2019, 02:29 PM


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Lol.

I hear what you're saying, but as we know it's not the m.o. of Wolgen to hire those with a proven track record in the field in question (think Agersborg on the board, LH in IR then general manager, think training from with and Clinuvel university). Mr Bull seems to have some solid commercial banking experience, but nothing in IR. He was never going to shake it up from day 1. I hope he can grow into the role and make it his own.
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Frogster
Posted on: Mar 4 2019, 11:58 AM


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First public namecheck for Mr Bull, the new IR Manager. Will be interesting to see how his profile develops.
Looks like this is an East coast Aussie only roadshow - delivered by Keamy. First one of those that they'd done for many years if my memory serves me well.

Nothing stunningly new (as you'd expect) but it does list "2nd indication Q1 19" as happening. This is comforting to me. I wonder why they only call it 2nd though. We have an approval for EPP. We know they are targeting VP also. Wouldn't that then make the next indication the 3rd? Or does this imply an indication beyond the porphyrias? Also, how does vitiligo fit in, especially since we've already had a few trials there?

US approval would "potentially double our EPP addressable market". Nice, and timely given the few comments recently about the size of the US market place.

EU expansion - "additional expert centres" are listed as the first point in "What's next?" Not clear if this is more centres in NEW countries, or more centres to address the bottlenecks in Germany for example.

Overall, nice to see more communications taking place.
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Frogster
Posted on: Feb 27 2019, 03:11 PM


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What intrigues me here is that the index tracker funds are unlikely to be front running any index changes. After all, they are passive only funds which invest on data, not speculation. However, plenty of active traders will be trying to position themselves ahead of any news. So, by my way of thinking, this volume is not driven by index funds. Yet.
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Frogster
Posted on: Feb 7 2019, 06:18 PM


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Wake me up when it's 123.45. smile.gif
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Frogster
Posted on: Feb 7 2019, 01:41 PM


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No, I don't think that's right. From memory 2 PSURs have been made annually to this point in time. They had hoped that this might drop this year to annually, but that hasn't happened so the status quo remains.


....
Just checked the text from the AGM presentation. It was 6 monthly, and remains so:

"Significant in 2019 will be the first reduction and relaxation of reporting obligations under the post-authorisation
commitments as agreed with the European Medicines Agency (EMA). Instead of safety analyses being performed
every six months to populate periodic safety update reports (PSURs), CLINUVEL will now be allowed to supply the
EMA with these reports once per annum, together with an Annual Report. Our teams are working to reduce the
burden to physicians and patients who literally spend hours recording diaries and transferring these data in the
European EPP Disease Registry with very little added value."

However, Wolgen seemed confident the drop in reporting would occur, and it hasn't. I can't imagine that this is anything to do with an actual safety concern, else we'd have heard about it! I'd rather imagine (speculate) it's more to do with the change in Rapporteur who, perhaps, just does things differently to the prevoius one.

Message to Clinuvel: why has this change to annual reporting not occured when at the AGM PW was confident it would? It was touted as a "significant" development. What has changed? It would be very useful if you had a functioning IR department which responded to "significant" questions like this. You are a A$1bn mkt cap company and knocking on the door of the ASX200. You can do better than this!
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Frogster
Posted on: Jan 31 2019, 09:10 AM


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Disappointing receipts number.

Having said that, with sales only ocurring in one region from one product the impact of any variation in payment timing can be very significant. Hopefully that's all we have going on here. It'd be very useful if CUV published some kind of data that helped us understand just how much is a timing effect, and how much might be reflective of underlying trends i.e. tell us average days outstanding for invoices, number of product orders/prescriptions etc etc. Simply saying yeah, there are seasonal and timing effects doesn't help all that much.

Admin and corporate costs at over A$1.033m were A$300k more than predicted. That's probably your extra FDA NDA#2 costs Johnny H.

Manufacturing costs were only A$593k for the quarter versus an expectation of A$1.3m. My guess is that these costs were avoided since the US launch is dealyed versus earlier hopes. They're again predicting A$1.32m for the current quarter, so the ramp up is still expected soon......let's hope they get this bit right eventually. All other cash flow guidance seemed inline.

So, a hiccup, but the result from early July is still really the only game in town.
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Frogster
Posted on: Jan 29 2019, 02:17 PM


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Looks like someone hasn't done their paperwork for a few years.


Attached File(s)
Attached File  3A509622_CUV.pdf ( 230.79K ) Number of downloads: 292

 
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Frogster
Posted on: Jan 25 2019, 10:45 AM


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Regarding your desire to see use in HDD and the like, I wouldn't be amazed if we saw an occasional off label use under the type of scenario you suggest i.e. an extreme therapeutic need. After all, we already know CUV has allowed off label use in 1 instance - that of a terminally ill CEP sufferer (AGM 2018). It's the cosmetic off label use that's the non-starter at this stage due to the distribution control systems in place in the EU and planned in the US.
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Frogster
Posted on: Jan 25 2019, 07:21 AM


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Wolgen and the board have made it quite clear time and time again they are not pursuing the goals and business model of Epitan, and they have significant voting clout to back this mindest up.

They have set up and are bound to an incredibly tightly controlled distribution system in Europe almost entirely to avoid off label use. They plan to implement a similar system in the US for the same reason.

Off label use for Scenesse in cosmetic applications is a non starter for this management team IMHO.

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Frogster
Posted on: Jan 23 2019, 06:40 PM


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From S&P/ASX Australian Indices Methodology, December 2018:


Investable Weight Factor (IWF)

Investable Weight Factor = 1 - Sum of the % held by strategic shareholders who possess 5% or more of issued shares.

All issues in the S&P/ASX indices - with exception of the All Ordinaries - are assigned a float factor, called an Investable Weight Factor. The IWF ranges between 0 and 1 and is an adjustment factor that accounts for the publicly available shares of a company. A company must have a minimum IWF of 0.3 to
be eligible for index inclusion. The company’s adjusted market capitalization determines an equity issue’s relative weight in the index.

S&P Dow Jones Indices identifies the following shareholders whose holdings are considered to be control blocks and are subject to float adjustment:

1. Government and government agencies;
2. Controlling and strategic shareholders/partners;
3. Any other entities or individuals which hold more than 5%; excluding insurance companies, securities companies and investment funds;
4. Other restricted portions such as treasury stocks.

IWFs are reviewed annually as part of the September quarterly review. However, any event that alters the float of a security in excess of 5% will be implemented as soon as practicable by an adjustment to the IWF.

The function of the IWF is also to manage the index weight of foreign-domiciled securities that quote shares on the basis of CDIs. Due to the volatility that is displayed by CDIs, unusually large changes in the number of CDIs on issue could result. Where this is the case, the IWF may be used to limit the effect of unusually large changes in the average number of CDIs (and, thereby, limit the potential to manipulate this figure). Where the Australian Index Committee sees fit to apply the IWF in this manner, the rationale for the decision will be announced to the market. This will be reviewed annually at the March-quarter index rebalancing date.

Your "long term holder" label isn't mentioned here by S&P/ASX. The closest similar would appear to be the strategic shareholders/partners label, which I'd interpret as commercial cross holding type arrangments rather than retail investors who happened to get in early and hold for a long time. So, unless you have 5% or more, yours should be included too as should most others held via nominee accounts or, for that matter, directly. On the above description, Lagoda should also be included.
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Frogster
Posted on: Jan 22 2019, 06:21 AM


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My spreadsheet is telling me A$7.0m.
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Frogster
Posted on: Jan 10 2019, 07:20 PM


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A further indication (XP?)
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Frogster
Posted on: Jan 10 2019, 09:51 AM


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Nice start to the year. 👍
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Frogster
Posted on: Dec 12 2018, 05:51 PM


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I understand the logic for the Dec 31 date you've quoted, but I'd note that the AGM slides put validation and decision on priority review as calendar year 2019 items.
I guess, if "satisfy(ing) these latest regulatory requests" (Nov 5) does not equate to actually resubmitting the NDA (if that's how things happened), that might explain how things could slip into next year.
I hope we get a PDUFA date this calendar year, but even if we don't, according to AGM timelines we should see the third indication and CUV103 results in this current calendar year.
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Frogster
Posted on: Dec 8 2018, 10:13 AM


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This is now a moot point - and I'm not sure if you're saying you don't think they got an RTF or if you're saying we should simply move on from questioning if they did or didn't - but if it's the former, then in my reading of it I don't think they actually stated they didn't get an RTF.

As you have quoted below, they stated that "no major outstanding issues....would lead or need to lead to a refusal to file". To me this still leaves room for a minor issue (or issues) which could, and perhaps did, lead to an RTF.

The reason the point is moot is because they have clearly also stated they have now "provided answers to each individual question to satisfy these latest regulatory requests", and I don't think there's any room for interpreting that in any other way than to understand they have answered whatever questions the FDA had and, making an implicit assumption support by this and other statements, things are rolling again.

My best guess is that they:

- got an RTF on minor issues only
- answered the issues quickly
- refiled, and we're now in the 2nd validation period

I cannot see another way that CUV statements and actions around this issue fit with my understanding of FDA processes.

I think, come an assumed filing acceptance and PDUFA date, all this will become a minor historical hiccup, and just another example of the sometimes frustrating lack of precision and explicit clarity that CUV communications bring. Less than perfect clarity from CUV is nothing new to any of us who've been around here for a while. If we get an FDA approval within the next 10-12 months, I expect I'll be happy with the result even if I've had a few grumbles along the way about how we got there.
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Frogster
Posted on: Nov 26 2018, 09:38 AM


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The incidence of inherited porphyrias in Europe (2012) by George Elder, Pauline Harper, Michael Badminton, Sverre Sandberg & Jean-Charles Deybach put the number, based on incidence, at 286.
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Frogster
Posted on: Nov 21 2018, 03:18 PM


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Well, what is there to say about the AGM 2018?

Not much of any great note. I don’t think I really learnt very much new, neither good nor bad. We know CUV is a company that doesn’t hype itself, and that was on display in spades. We’ve seen before that PW’s style and M.O. is one of caution. No Elon Musk type hype from this guy, ever, in my expectation. That’s neither good nor bad I guess, it’s just the way it is, and it’ll never change.

In no particular order:

Aspects of the presentation were historic in nature, and struck me as a new way of presenting old information. I guess there will always be an element of this in an AGM presentation. Regarding forward looking stuff, PW was very limited in his commentary. He cited confidentiality arrangements, and really gave no “update” on key issues of NICE or the FDA. I didn’t get the sense this was for any negative reason, but rather due to an abundance of caution.

If last years AGM saw an expansion of detail on expected milestones, timelines and events, then this year saw a reversion to the default position of saying as little as possible. I’m note sure if that was due to being a little burnt by the things they “missed” doing in the last year, or whether it was due to the current hiatus with the FDA putting everything in hold. A bit of both probably. If it wasn’t already obvious that the last newsletter, which saw PW answer minimally some key questions we’ve had (i.e. where’s the OTC gone?), then it became very clear that was done to head those questions off at the pass prior to today.

Vitiligo: some reasonable time was spent on this. CUV103 was announced as being almost ready AGAIN. How many consecutive AGMs is that now? 3? 4? 5? They must surely have some insight on the data by now, and to keep mentioning it must suggest the data is good (to me at least). It seems obvious they are just waiting for the time to be “right” before revealing. When is “right”? FDA progress on EPP is my guess.

Brief presentation by Blijdorp. He talked a bit about his long running history with CUV, about his belief that people make the difference in companies, and why he spent up big to take his stake. As per his section in the A.R., this seemed to be another stage is introducing him to us. It did nothing to reduce the view that he’s being lined up as the next Chair after Stan finally retreats from the stage. As a very successful businessman Blijdorp is due respect. His reserved, unflashy presentation style appears similar to that of PW.

Prof Minder from Tremli said a few words. She’s administered over 1,300 implants. To her patients, and in her professional view, the product works, and has only minor side effects. Nice to hear first hand what we already have read from many locations. In fact, I’m sure I could hear a low level background chant of along the lines of “safe and effective” being piped over the PA throughout proceedings.

Japan/Australia in EPP was presented as having the same pipeline status as the US. Does that mean an application has been lodged? Sorry, not clear on that.

On the disclosure question below, there are two different things in play. PW mentioned that the company will continue to report quarterly cash flows (the 4C), even though we know they now probably don’t have to. He also stated separately that the frequency of reporting safety data under the Post Authorisation safety protocols to the EMA drops from every 6m to every 12m. Two very different things obviously.

Much flasher location than last year, and particularly the year before. I don’t know that there were many more attendees than previous years. Maybe a few, but not that many. Flashy ceiling to floor screen on the stage, but not helpful to have annotations and translations lost at the bottom of if by the back of the head of the person in front of you.

Overall, if you didn’t make the trip over, you didn’t miss much. Nothing major new bad. Nothing major new good. FDA is the only real game in town, and there’s nothing new to add to that just now.

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Frogster
Posted on: Nov 19 2018, 09:24 AM


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I believe a number of the usual suspects will be attending.
Regarding Q&A, the allocated time has never been a limiting factor. Historically not all that many questions have been asked - perhaps up to 8 or 9 - and some might suggest not all that many have been answered either.
In the context of significantly more comms effort this year, it will be interesting to see if they take a more generous, engaged approach to the answers this year.
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Frogster
Posted on: Nov 16 2018, 03:11 PM


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Didn't he say early Christmas present for 2019? It wouldn't rule out early 2019, but I'm pretty sure those were his words.
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Frogster
Posted on: Nov 14 2018, 03:43 PM


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Thanks so much for posting.

He seemed to be smiling alot more than he usually does at the AGM.
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Frogster
Posted on: Nov 12 2018, 03:01 PM


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Is the Walnut paid too much? A rather simplistic analysis, but for what it's worth:

https://simplywall.st/stocks/au/pharmaceuti...stay-motivated/
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Frogster
Posted on: Nov 5 2018, 02:16 PM


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Also, hopeful NICE will engage in a managed access scheme and the delay in the OTC product line was due to issues at a supplier - now hopeful of launch in the New Year.

Furthermore, some defence of the Chairman against those who were critical of his comment that the further FDA questions were antcipated before the NDA.
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Frogster
Posted on: Oct 30 2018, 06:58 PM


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I've been on the road these last few weeks, and not been following in detail (probably just as well). Have they actually said they've submitted the extra info, or have they only said fda hasn't commented on time lines? I know this was the case when they announced the initial delay (throw shade at the fda, but hide from the fact a large part is 100% down to them) but I wasn't aware that the first stage to solution (to answer the query) had been reached. I sure hope it has!
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Frogster
Posted on: Oct 15 2018, 07:35 PM


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Probably just 10 of us checking in 9,000 times each.
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Frogster
Posted on: Oct 12 2018, 07:39 AM


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Anyone who owns CUV shares is entitled to attend. Doesn't matter how many or how few. It's a bit more murky for CLVLY and UR9 holders. Some have (I believe) been denied entry previously, and CUV has not enterred into a dialogue (as far as I know) about how to arrange entry for these holders. I suppose a CUV holder might be able to nominate someone as proxy to vote their shares (or perhaps just 1 of their shares). I don't know if being a proxy also entitles you to ask questions.
In the past they have never been recorded, broadcast or transmitted. Doubtful that will change - you have to be in the room.
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Frogster
Posted on: Oct 12 2018, 07:16 AM


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Wouldn't it be handy if the answers to those extra 2 questions and resultant acceptance of the NDA coincided with the AGM where we might just be asked to vote on the NEXT performance rights plan?
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Frogster
Posted on: Oct 4 2018, 02:32 PM


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Clearly Lagoda has sold a bunch of shares on the market, but this announcement also highlights that Richard Bayles has left Lagoda and, seemingly, taken a bunch of accounts (Brown Brothers, JPM, State Street, US Trust, Wells Fargo) with him.
It looks like he might have gone to Oppenheimer, and presumably they will now be managing these shares instead.

Lagoda loosing the mandate to run these funds looks to be a bigger factor in them ceasing to be a substantial holder rather than quantum of the listed disposals (which I only added up by eye).
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Frogster
Posted on: Sep 26 2018, 10:30 PM


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$40 share price (or more) might be possible in that time frame with positive fda news, 2nd indication, good cuv103 results, asx200 etc. etc., but I don't expect we'll be seeing A$94m annual revenues and A$76m earnings in a reporting period that closes 9 months from now. I'm very excited by what's finally going on, but I'm trying to keep some realism about how the business is likely to progress. Remember this is CUV. Between hares and tortoises, they have a very hard shell.
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Frogster
Posted on: Sep 26 2018, 09:49 PM


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I'm not sure what you mean by 1,200 "confirmed patients".
If you mean patients being continually treated today, that sounds pretty high to me.

In the recent 4E and the NDA submission announcement from 25/6/18 they pointed out the data set submitted to the FDA (i.e. pretty much everything the know about the drug) encompassed "nearly 6,700 afamelanotide doses administered to more than 800 patients" and in more recent presentations they've been talking about >7,900 doses and >975 patients in 34 clinical trials.

Of these 800-975, this includes many from trials in regions which are not currently reimbursing the product and it's not all patients in trials for EPP alone. I don't think CUV has given an official number of current EPP patients, but if revenue is circa A$26m annually (FY17-18), and approx treatment cost E70k*1.62 then that equates to a current patient population well below 1,200. A few hundred at present it would seem. Sure, we can hope for growth here, but it will take time.

I'm not saying there isn't the prospect of strong growth over coming years, especially with a US approval, but I think we're quite some way from A$94m revenue on European EPP alone.
Totally agree with the growth drivers you've listed thereafter.
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Frogster
Posted on: Sep 22 2018, 05:28 PM


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Maybe they'll correct "Clivucel" too rolleyes.gif .
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Frogster
Posted on: Sep 22 2018, 03:08 PM


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From yesterday:

https://scrip.pharmaintelligence.informa.co...n-Drug-Scenesse

It won't let me start a free trial for some reason. Can anyone else access the interview and share it here?

Damn. Beaten by odi01.
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Frogster
Posted on: Sep 21 2018, 04:11 PM


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A casual 576,000 shares traded for the day, with another 540,000 still (currently) showing on the bid.
A happy weekend to one and all longs.
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Frogster
Posted on: Sep 21 2018, 04:05 PM


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Interesting post close market depth!
I guess this is a pre ASX300 inclusion thing.
Will be interesting to see how the post close auction pans out.
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Frogster
Posted on: Sep 20 2018, 10:03 AM


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PW emerges.
Attached File(s)
Attached File  02024364.pdf ( 1.73MB ) Number of downloads: 290

 
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Frogster
Posted on: Sep 11 2018, 07:42 AM


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39,328 share trade at 18.462 showing on CHI-X already today. I wonder if that's a hangover from yesterday, or genuinely from today.
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Frogster
Posted on: Sep 10 2018, 01:53 PM


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At the current share price our mkt cap is bigger than 6 companies currently in the ASX200.
Just saying.....
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Frogster
Posted on: Sep 8 2018, 07:41 AM


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Hi Peter. Welcome to Sharescene. That must be the most liked first post ever on this forum!
Thanks very much for your research on CUV - it's very much appreciated.


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Frogster
Posted on: Sep 5 2018, 07:31 PM


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I've just been putting together some similar thoughts to you Mauricinho. I was typing this whilst you posted your view:
I've been trying to get my head around where we are in the application process, and I must say I've now worn a nice neat circle in my carpet.

On 23/8 CUV88 posted the following link:

https://www.fda.gov/downloads/AboutFDA/Cent...s/UCM218757.pdf

This is an FDA desk reference guide (a 59 page summary) to the CDER process for reviewing NDAs dated Sept 2014. It's a few years old, but I can't find any updated process so let's assume it's current. It highlights all the dates by which FDA actions must take place, and what those actions mean.

The bulk of what's relevant today is between p17 and p21, though Appendix A is also very useful. Points to note:


1) Preliminary FDA decision on Priority/Standard review designation is made by Day 14 after application receipt. (Appendix A)

2) Priority/Standard review designation is confirmed at the Filing Review which will take place by Day 45 for Standard review or by Day 30 for Priority review. (Appendix A & p17)

3) At the Filing Meeting there are 3 potential decisions (p20):

a. File the application (no major omissions or deficiencies, minor issues may exist)

b. Potentially RTF the application (correctable deficiencies exist, if they are fixed by Day 60, the application is filed)

c. RTF (deficiencies cannot be rectified readily)

4) For filed (accepted) Priority reviews a "Filing Notification" letter will be issued by Day 60, along with a "No Filing Issues Identified" letter by Day 60, or a "Filing Issues Identified" letter between Day 60 and Day 74. (p21)

5) For filed (accepted) Standard reviews a "Filing Notification" letter will be issued by Day 74 along with a "No Filing Issues Identified" letter or the "Filing Issues Identified" letter. (p21)

6) "Program" Review Timelines for filed applications will be submitted by Day 74 i.e. FDA communicates ongoing timelines promptly. (Appendix A & Section 3.3)

7) - If an RTF decision is taken at the Filing Meeting, an RTF letter will be issued within 60 days. An RTF ends the review process. The NDA will have to be resubmitted with deficiencies addressed and will be considered a new application, or they can be "filed over protest". (p20)

So, what does all this mean about where Clinuvel is in the application process? If we consider that Clinuvel has made a single NDA application on 22 June, then the FDA will have made its Priority review decision at the Filing Meeting held within 30 days of that. If CUV is telling us no Priority Review decision has been made, then I cannot see how that can be the case for a "still live" NDA made on 22 June. There appears to be no process "pause" button, no "extension" process which can push back the Priority Review decision. It seems that at this stage the 22 June application is either filed, or it is not. If it is not, then CUV has had an RTF letter, which it would have had by Day 60 – 2 weeks ago (Continuous Disclosure anyone?). If we've had an RTF letter, then that application is dead - apart from if they've filed under protest, but then a Priority Review decision would've been made - and another application will have to be made.

If it is filed, then CUV would've been informed by the FDA of its review status either way.

So, the only thing to me that makes sense is that they've had an RTF letter and will need to resubmit the entire NDA with corrected deficiencies. If no resubmission has yet occurred, then of course no further timelines can possibly have been provided by the FDA. If a resubmission has occurred, then the timelines are known. I don't think we currently have an NDA in front of the FDA.

If this is the case, then it's at best a pretty disingenuous release today. At worst it's highly misleading.
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Frogster
Posted on: Sep 5 2018, 02:55 PM


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So, this is frustrating as all hell. So many, as usual, unanswered questions.

-Is it a formal RTF or not? We don't know.
-Or, has the application in fact been validated? Not clear, but it would appear not.
-Has the review "clock" started yet? Subject to the above my guess is no.
-How can this happen after such long-term intimate FDA contact? Well, apart from incomptence somewhere in "our" process I guess it's hard to say.

I get that the FDA might not have shared timelines to the PR decision once the inadeqacies are covered, but there is no acceptable excuse for not sharing with us timelines to submitting the relevant data. Heads should roll, but of course they won't since they like carrots but seem to be fresh out of sticks. Where is Wolgen in all this? It seems like he's terrified of putting his name to anything other than "Newsletters" these days - he's always putting up someone else to make the commentary. Very odd.

Having said all that, "product manufacturing information" and "details from the Europen post-authorisation use of Scenesse" sound, hopefully, easier to address than questions around efficacy or safety.

It's a bump in the road, but hopefully not a Blues Brothers style incomplete freeway.
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Frogster
Posted on: Sep 5 2018, 12:12 PM


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"Through diligence and integrity we advance and serve the people."
Is this becoming another countdown clock?
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Frogster
Posted on: Aug 31 2018, 05:07 PM


Group: Member
Posts: 692

Well, what a nice way to head into the weekend.
RC, if you still read this board, drop me an email at frogsterfrogsterfrogster@gmail.com please.
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Frogster
Posted on: Aug 30 2018, 10:09 AM


Group: Member
Posts: 692

You might be right ultimately - there's certainly no compelling operational reason to stay domiciled here. If our speculation about Blijdorp becoming chair is correct then 3 of 4 known directors themselves would be domiciled outside of Australia. Personally I'd expect any exit to be staged. I'm not sure CUV will ever be paying a fully fraked div anyway!
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