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polyphemus
Posted on: Feb 7 2020, 04:01 PM


Group: Member
Posts: 532

Is Clinuvel going bankrupt? No - it is well funded and has positive Cash flow.
Will Clinuvel earn more this year than last year? That is the current contention, I think it will but current cash flows suggests otherwise.

Naked shorting is illegal in Australia. The law allows the seller to borrow stock, then it is not considered naked short.
JP Morgan will be the group that is lending the stock. They have plenty in their nominees. It will not be BNY.

Market Making - market making is a term used for derivative products. There are two that are relevant. 1. BNY will make a market in US ADR in the security. They buy and sell shares on the Australian market to cover their exposure in the US ADR market - the market making is in the US not Australia and ADR's not CUV shares. They will make a spread to allow opportunity for buyers and sellers to execute. 2. Citibank will make a market in CUV Warrants - they will make a spread that allows traders to acquire and exit. To cover their position (which are all Call mini Warrants, meant for trading not exercise conversion to physical. They do not have an expiry date but can be exercised for Cash not stock.) Citi do not need to own CUV to hedge their exposure, but they can if they wish - they make money from the spread generally - but I have seen that securities with these warrants can have intraday flash movement that hit the warrant close out price a little too often.

There is no Market Making in Clinuvel. The current behavior is not price discovery. It has one intent which is to beat the market. It can be a simple CUV is over priced or a more complex CUV will under perform and other securities will out perform. Sell the under performer and transfer money to the out performer.

In Australia Exchanges are not allow to incentivise liquidity i.e. pay for activity.

Alpha Hedge Funds is an active approach to investing - hedge funds are trying to achieve a greater rate of return than the market. If a hedge fund thinks that a security is undervalued it will buy, or if it is illiquid it will look for a proxy equivalent. If a hedge fund thinks a security is over valued based on whatever parameter e.g. PE or PEG then it will look to profit. In this case borrow the stock at cheap interest rates and then sell the security. They have to Buy the security back to close the borrowed position.

Index Funds are a passive approach to investing. They do not short. Each fund will have an investment mandate which prescribes the investment purpose, types of assets it can own and the behaviour of its investment style. See the Australian Future fund (which is not an index fund) as an example https://www.futurefund.gov.au/investment/ho...stment-mandates

Index funds simple buy a representative security portion of an index. If for instance CUV represents 0.6% of an index and then through a price rise represented 0.7% of the index, then an index fund would purchase. Vice versa if the % weighting were to fall then the index fund would sell to keep its comparative weighting. This is the same for SMA and IMA structured products.

CUV has 49.4 million shares on issue. Currently though there are a fabricated 4.4 million extra shares. This impacts demand and supply. Has Demand gone down? No Supply has been artificially increased.

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polyphemus
Posted on: Feb 4 2020, 08:27 AM


Group: Member
Posts: 532

I believe CUV shares are falling due to an exerted attack from the Short Sale desks.
Not from lack of news. US sales should be expected this year but not this early.
It should not be managements job to fight Market behaviours that allow dubious practices.
CUV Roadmaps historically come out with the half year report so I would only expect a couple of communique's over February. Any other announcements are gravy e.g. Trial start dates or New indication finally named.
Management is already aligned with the gratuitous incentive scheme which includes Market Capitalization growth.

Yesterday was laughable when the stock was looking like going upwards before lunch on only 30K in volume. I noted that other Aussie Biotechs with no China link had no issue yesterday and most went upwards.
This strongly indicates that the current price is artificially low compared to demand.
This year there has been an extra 0.5% of stock basically created from thin air for these sales.
The last 7 trading days have been the worst.

I am not convinced yet but I suspect that there is more of a large buy order being worked into.
There is just no real money to be made on a CUV short from these positions. Revenue per share and Earnings Per Share will not go downwards.

From a personal point I think anything that is sub $32 is cheap and that current values offer a 20%-25% safe return.
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polyphemus
Posted on: Jan 31 2020, 10:48 AM


Group: Member
Posts: 532

Perhaps receipts are growing by 1.5% in Europe or perhaps they grew year on year for the qtr by 43%. Depends on the view.

Expenses are up Year on Year 46% with the largest variation in Product manufacturing and operating costs up 117% for the qtr and 305% for the 1st half.
The statement that it is preparation to expand into new markets bodes well and appears and would be expected to increase near term expenses.

If you review next qtr's expense estimates year on year Production expense is up 21% and staff up 64% confirms the expansion. R&D is also getting a push.

Market seems to like the numbers anyway. I can't help but feel with the shorts continuing the attack (yesterday short another 85,000) and rhetoric that there is a buyer filling up.

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polyphemus
Posted on: Jan 30 2020, 02:48 PM


Group: Member
Posts: 532

CUV does not issue profit guidance. We find out tomorrow the real state of Q2 2019/2020

The shorts are basing on a purely quant reason. The real question is whether the company is growing revenue....

WE find out tomorrow. Huge attack today. My guess is shorts have failed when I am looking to buy.
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polyphemus
Posted on: Jan 29 2020, 02:43 PM


Group: Member
Posts: 532

Spike in volume today. Some one is filling up i.e. has a positive outlook on the stock.
Shorting has been consistent over the last week except for yesterday when the overall market crapped itself. Surely they do not have access to too many more shares over 4m that they have already sold.
Bring on some good financials and then follow up with some progression on product.
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polyphemus
Posted on: Jan 23 2020, 01:54 PM


Group: Member
Posts: 532

I think we were all wrong about the tenacity of the short commitment.
They sold another 77,044 yesterday.
They have been able to use the psychology to churn some of it daily and keep prices in their favour. It is an illiquid stock with a conservative restricted management strategy (from a day to day perspective) so that should be fairly easy for a whale to control emotion.
I think the problem for shorters is that there is also a large commitment from longer holders not to panic.
We are quite use to 30% swings over short to mid term.
I definitely have a buy point each time the price swings under a specific point. Not the current range - I think it should be circa $33 at the moment.
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polyphemus
Posted on: Jan 23 2020, 10:36 AM


Group: Member
Posts: 532

Having borrowed 7.72% of the company's shares I wonder just how much more the Short positions have access to or how large they want their position to grow while continue holding the price at deflated values.

I suspect and hope that the financials out next week indicate a stronger December quarter than the 2018 period.
Stating the obvious, continued strength in the balance sheet should give confidence to potential investors.

I was only expecting US revenues this year in the Apr-Jun Quarter of circa $5m-$10m. But I see the potential for earlier revenue with any individual who is already covered by their insurance provider. Beats flying the Switzerland.
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polyphemus
Posted on: Jan 17 2020, 01:01 PM


Group: Member
Posts: 532

The communique really was a hard read.
I preferred last years. It had a lot of detail on
FDA PDUFA details,
Vitiligo update,
VP update with trial CUV040 likely to start in 2019,
New Indication just needing ethics, funding and protocols to be agreed so it could be disclosed,
Expansion of business plans of the Valluarix team in late 2019
Statements on Brexit and NICE lodgement

This year were simple bullet points on aspirations
a. clinical progress in vitiligo;
b. complementary OTC product(s);
c. a new indication;
d. investigation of DNA repair;
e. expansion of R&D;
f. US market access;
g. Australian TGA submission accepted, initiation of the review; and
h. European market expansion.

Does not seem to matter though, market has been pretty positive today.
Maybe some investors got a debrief at the JP Morgan Health Care conference yesterday.
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polyphemus
Posted on: Jan 15 2020, 04:12 PM


Group: Member
Posts: 532

In Australia I believe a small number of EPP people that went through trials and found it life changing have been using scenesse for the last 10 years under compassionate grounds from the company for up to 6 doses per year (QLD is always sunny).

With registration dossier submitted @ 23/12/2019 (assuming accepted by the TGA), we should expect before the last week of May 2020 approval.

I would suspect that compassionate grounds will cease in July 2020 .

My guess is that the PBS will not subsidise and that it will be insurers to cover. PBAC meeting would be August 2020 for review on any subsidies.

A 1992 Australian Clinical Biochemist review indicated an estimate 1000-2000 Australian porphryia cases with 5-10% epp i.e. 50-200 Australians.
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polyphemus
Posted on: Jan 14 2020, 02:09 PM


Group: Member
Posts: 532

Been reviewing the Moelis research with a Buy rating and a 12 month Price target of $44.42 -

The analysis does take in some qualitative aspects in regards to the FDA approval process which was good to see.
I still believe that they have 2020 tax incorrect at 30%. The company has $85m of unused Tax losses.
This would put NPAT at higher levels than the research shows for both 2020, 21 and 22 which will change the EPS growth, expected div, cash flow and cash on hand significantly.

On the flip side the research does not indicate any increase in Operational expenses either for new staff or the two known upcoming Trials. These would all be more likely to be negative to Cash flow.

Regarding the statement on expected US revenue as 2h2021, this is taken from the AGM presentation for an out licenced model.

QUOTE
In this conservative hypothesis we assumed that zero growth rate in revenues would be booked from 2019 to 2022 onwards.


If we use the European market as a basis Dec 2014, marketing authorisation was given - it took two years to get traction revenues.
Each country had distribution and pricing to finalise.
With the US, it is one country. Next steps are to get any labeling guidelines/post treatment monitoring protocol and set up a distribution mechanism.
Insurers are most likely on board as noted from a 'Stockhead' reported quote from the CEO.

QUOTE
Of course, much depends on the availability of reimbursement, but Dr Wolgen notes that US insurers are already stumping up for US patients to be treated in Europe.


Historical revenue, top line and operating income bottom line
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Happy to see the research - just a couple of items that probably could have been considered more by the analyst/s if they had time. Or perhaps the CUV can start talking to analysts to clear up any potential mis-representations.
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polyphemus
Posted on: Jan 8 2020, 09:17 AM


Group: Member
Posts: 532

Relax - it is only the start of the year and things take time to organise and then chip away at.
QUOTE
The clinical challenge and the commercial opportunity are both immense, and we are now preparing for two trials.


The company is profitable and well funded for this phase of extension of Product.

The company is already expanding Product lines into the US and we can expect a material impact this financial year from the Apr-Jun sales.

DNA repair is the next big thing. If it is for Keratosis as a result of UV damage.
While the CEO did say that they had been considering sun UV protection since 2005, they did not have a topical method - that was developed for Vitiligo.
I think he also mentioned that it was the history of data collected that has solidified the view that scenesse has an impact on progression of Keratosis's
QUOTE
potentially being an anti-carcinogenic agent able to slow down, mitigate actinic damage and assist in DNA-repair.
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polyphemus
Posted on: Jan 7 2020, 08:36 AM


Group: Member
Posts: 532

The results for December quarter are 3 weeks away and the shorts persist to drive weakness after any minor rally.
I would hope we can beat last years negative Dec qtr cash flow of -$625K

There were a couple of variations in the Sept 19 quarter compared to the Sept 18 quarter.

1. Sep 18 had $186K in prod manufacture vs Sep 19 $1,868K in Prod manufacture --> indicative of a larger record in receipts expected.
2. Sep 18 est Dec 18 prod manufacture had $1,300K vs Sep 19 est Dec 19 prod manufacture had $1,100 --> indicative that expected product demand is still resilient
3. Divs were paid in Dec 18 qtr vs Divs paid in Sep 19 qtr --> positive for the Dec 19 overall cash movement
4. Sep 18 est Dec staff costs were $1,360K which was accurate to actual of $1,033K. Sep 19 est staff costs are $2,230K - $870K more which is negative for overall cash flow.

I think it is line ball but in favour of positive cash flow for Dec 2019 qtr.

As for the potential for a Shareholder communique I look forward to further direction on the DNA repair.

I would pay up for a cream (not $75K per year) up to about $1500
QUOTE
– I have the utmost confidence that they will once again succeed in this final mission of illustrating the ability of SCENESSE® to affect DNA-repair in diseased and non-diseased individuals, those at high risk for actinic damage. The market for these prescriptive and non-prescriptive products should be sufficient to keep everyone around this Company excited and able to withstand momentary volatility in share price.
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polyphemus
Posted on: Dec 13 2019, 10:11 AM


Group: Member
Posts: 532

I had some beers a couple of weeks ago with a few of the Moelis team. The discussion turned to Clinuvel at one point.

The was an offer for me to name a price to which I would be willing to sell which I was of no interest. They were rather persistent which I put down to booze.

Did get me interested in their enthusiasm to make an a deal. I had a look at their research Attached File  CUV___4Q19_cashflow___31.7.19.Pdf ( 355.79K ) Number of downloads: 122


Further review - this is paid for Research by the ASX to Moelis. Part of an initiative to get more exposure by the ASX of smaller mkt cap securities.
The analysis is basic quant analysis with no fundamental review of the company.

I would like to see larger institutions to initiate Research. The most thorough research to date is still sphene capitals 40+ pages, which is a little aggressive in its timelines.
The next comprehensive set is Nomurra from 7 years ago - available on the clinuvel website. Their fault for reference was picking the annual price as $1500 which I think is on the low side for Vitiligo.
Nomura also had an enthusiastic time line for EPP as 2016 with eps 95c. (we have had some minor dilution since then but not 60c worth)
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polyphemus
Posted on: Dec 10 2019, 08:22 AM


Group: Member
Posts: 532

The graphic displays EPP when the annual cost was unknown - it was expected to be between 15k-20k Euro per annum, although at the time Italy was indicating 32K Euro.

As we now know that PW was able to organise a 70k Euro per annum uniform price. This is expected to be carried over into the US.

So double or quadruple the graphics estimate of $ market size for EPP.
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polyphemus
Posted on: Dec 6 2019, 11:47 AM


Group: Member
Posts: 532

I expect they are currently working on Vitligo next steps pushing on from the phase 2 trials;
QUOTE
“The next step will be to define the future label of SCENESSE® in vitiligo patients. It is imaginable that patients who have lost more than 10% of body surface area pigmentation would be eligible to receive the treatment. Vice versa, it is obvious that a patient who has less than 2% body surface area loss of pigmentation may not opt to receive a systemic injection of afamelanotide, but perhaps would use a topical formulation. Clearly, we are positioning ourselves at the forefront of vitiligo treatment and are developing a number of scientific tools to accompany the technological innovation we wish to introduce,”


Although the Phase 2 has finished the little bar has not moved to the end yet.
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polyphemus
Posted on: Dec 2 2019, 01:56 PM


Group: Member
Posts: 532

I would suggest that the website team update https://www.clinuvel.com/pharmaceuticals/pi...rch-development to include CUV150 and CUV151.
Talking in total ignorance these should be Phase 2 Trials to determine efficacy. Scenesse had already passed Phase 1 markers several years ago.

My assumption was that PW was talking about CUV150 and CUV151
QUOTE
The clinical challenge and the commercial opportunity are both immense, and we are now preparing for two
trials.

and not about Vitiligo CUV104 and CUV105 which I am assuming are Phase 3 trials and will progress early 2020

Not sure what to expect with CUV9900 and VLX001 - if they are topical do they even need trials? I assume they will be used to support 104 and 105

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polyphemus
Posted on: Nov 26 2019, 12:08 PM


Group: Member
Posts: 532

Starting the Trials allows analysts to focus on future cash flows.
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polyphemus
Posted on: Nov 26 2019, 09:50 AM


Group: Member
Posts: 532

We can expect a News letter or Communique either end of next week or the start of the week following.

We can also expect that the Short market will persist until news of relevance is issued or Institutional Analysis is completed. News of relevance will not be in the news letter.

I would not expect an update the Roadshow pitch until next year.

The next forward action events are phase 1 on new indications or phase 3 for Vitiligo.
Phase 2 Singapore results
• Repigmentation therapy with SCENESSE® in combination with NB-UVB effective and safety profile maintained:
– Statistically significant increase in pigmentation on areas of vitiligo for total body, areas of head and neck
(VASI, p<0.001 at Day 196), as well hands, upper extremities, trunk and lower extremities (VASI, p<0.05
at Day 196), with exception of the feet
– Maintenance of pigmentation observed at Day 280, three months after the end of the treatment
– Combination therapy of SCENESSE® with NB-UVB well tolerated

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polyphemus
Posted on: Nov 23 2019, 04:49 PM


Group: Member
Posts: 532

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There are reasons that the 12 month project Price targets are above $50AUD $34AUD.The main one is that cash flow will grow by double digit this 19/20 year and close to triple digit 20/21 year.That cash is being used to support the pipeline tests and the portfolio. I can not say I am in anyway informed on the the use of CUV9900, VLRX001 and VLRX002. We are informed on Vitiligo - the results look promising and effective. That will push the value of the company.I would expect a December update from the company - hopefully with ethics approval on the '3rd' indication.
I also expect the shortman to dissipate. I may pick up a few of those warrants minis - be careful on them though they have stop loss triggers that close the deal. When genuine liquidity is missing a stock can easily be pushed in either direction.
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polyphemus
Posted on: Nov 18 2019, 11:04 AM


Group: Member
Posts: 532

CEO salaries came out in Australia as compiled by the Financial Review. How timely.

For 2018-19 Top 50 execs took home ~ $318m in Salary - average $6.3m

Good to see that the glass ceiling for women has been smashed with the Macquarie Shamara Wikramanayake taking the top gong with $18m. YTD to date return on the stock of 27%. ($48B mkt cap. Increased each share by $29)

CSL CEO Paul Perreault took home 3rd spot with $11.7m. YTD return of 46%. 2 year return of 90%
($123B mkt cap, wow huh, increased the value of each share $86 in one year - helps when you have the Flu market all to yourself)

CUV is well positioned with Vitiligo. 7 year old Nomura research indicated at least $7.73 per share earnings at $1500 per implant. And this was still cheaper than the current regime of treatment for Vitiligo for insurers of $12-$13K per treatment period.

I wish we had more analysts taking note of CUV, that were prepared to put their reports out - it has a good drug, reasonable results and cashed ready for the next phase of growth.
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polyphemus
Posted on: Nov 8 2019, 10:16 AM


Group: Member
Posts: 532

I note there is a large Product Manufacturing cost reported last quarter of $1.868m

Compare that to annual product costs
2018/19 year product cost was $4.181m. Revenue $32m
2017/18 year product cost was $2.804m. Revenue $23m

What we have year on year is a 904% increase in Product cost in Sep 18 quarter or 138% from the Sep 17 qtr
Yet Product sales were down QoQ and YoY for the quarter. Appears odd, there was no commentary on this only the Dividend.
Estimated Product costs for Dec qtr are at $1.1m - this would be an 85% increase yoy

So why the 904% increase in Product costs? and further next quarter predicted 85% increase yoy following?

1. Increase in sales expected? Seems really optimistic by management to accumulate so much. Either in the US or Europe during the coming quarter sales must be expected that continue into the jan-mar period.
2. Initiation of R&D new Trials with scenesse may have occurred - sounds like a very big Trial hmmmm what indication would that be for?
3. Re weighting or 1 off expense of Product contract costs to cover increased manufacturing quality requirements

It indicates that we should expect a much larger revenue for Q4 posted versus the same period in the previous year or R&D.
I see nothing yet to dissuade a belief in an estimated eps 60c for the 2019/20 year.

I would like to think that 900% will be matched in Revenue increase but that is after a few drinks and if when Vitiligo is successful and gets a go ahead.

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polyphemus
Posted on: Oct 22 2019, 10:24 AM


Group: Member
Posts: 532

Getting a bit too far off topic with shorts - there are many fed up market participants with current behaviours withing a supposedly Fair and Orderly market. You can read the gripes here.
Petition - Stop Dishonest practices

Yes we can say categorically and empirically that shorts are controlling this current CUV share price. It is not speculation. It is ASIC reported 10-25% of activity is by groups that do not own shares.
Algorithm that place orders every 20 seconds to the next price step do apply pressure. Both directions.
Their design is to attack other basic trading patterns such as used by Technical traders and order execution strategies VWAP / TWAP / Stop Loss.
Their design is to socially engineer a result. The creation of speculation of rationale reason that other owners are selling. As the news reports it, "Investors took profits" etc.

Back to the Point
An inflated share price does not allow execution of the Employee Contract because the clauses within that Contract would have already been met.
This is poor (at best) Contract negotiation on behalf of the Company. This is good Contract negotiation on behalf of PW.
When the Company contracts employee agreements poorly, Shareholder interests are not looked after. There are more than 1 shareholder other that PW with interests to consider.
You have to ask, do Shareholders have the necessary information to make an informed decision when voting? Of course we do not, which is why we rely on the remuneration committee to do their job.
You can not tell me that paying the CEO $10m- $20m-$30m respectively is not enticement enough for a CEO to do their job - why does it need to be $70m?

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polyphemus
Posted on: Oct 22 2019, 08:03 AM


Group: Member
Posts: 532

This company will go up regardless of the CEO, most analysts already have a $2.5B target on the company in the next 12 months.

This is an ethics and integrity situation.

Any Business trained CEO will suffice to execute the next phase.
The course has been set by the current CEO. He did a fantastic job in making the company profitable with getting uniformed pricing.

That still does not justify absurd, irrational payments.

There are some very disturbing patterns which indicate manipulation for self serving needs. This was noted by the Sphene analyst publicly;
QUOTE
Hasler explains that he has found it is "highly complicated" to get a meeting with management. This is unusual, he says, "since management must be interested in attracting new potential shareholders since this increases shareholder value – which is the number one job for the executive board!"


There is a reason other indications/products have not been discussed yet but they are quite happy to discuss in a published contract. It does not pass the pub test.

Here is a quote from PW from April 2019. There is this amusing co-incidental correlation with shorting starting at this point.
QUOTE
"The company has done well on its own merits and then individuals suddenly springing up putting a $40 price on the company – maybe some of my peers might like it, but I don't like this kind of pressure," Wolgen tells AFR Weekend from the UK where he was meeting investors.


Company runs up post the $2B mark post FDA and that is no good for a Contract that has yet to be announced which has a target of 1.75B and 2.1B

Now this same CEO has no problem with pressure of putting the company to $150. Somewhere he had a change of heart in 6 months.

This is hopefully just gross incompetence from the remuneration group and contract managers.
Whether intentional or unintentional the main beneficiaries of recent price movements are the CEO and remuneration group which proffered a broken contract. My guess is the 15 day average was added recently.

How can you vote for something that has already been achieved.
Watch the shorts evaporate after the AGM. New highs will be in December 2019.

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polyphemus
Posted on: Oct 21 2019, 01:02 PM


Group: Member
Posts: 532

I can not vote for performance incentives that gives anyone AUD $230m for 3 years work.

It is obscene - incentives of 1/10th that would be sufficient. PW has already grafted his share position not by purchase but by these ridiculous contracts.

Such an incentive would make PW the highest paid CEO in Australia and in the top 10 in the US.
The current top CEOs in Australia are Nicholas Moore of Macquarie Banking Group (MQG mkt cap $47B) and QANTAS airline Alan Joyce with $23.8m a piece (QAN mkt cap $10B)

NY Times highest paid CEOs

Time to look for a new CEO with integrity to do what is right for the shareholders. The group that drafted such a contract are grossly negligent.
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polyphemus
Posted on: Oct 14 2019, 11:09 AM


Group: Member
Posts: 532

I do not believe gaming an exchange market is illegal.
Window dressing may be relevant only by behavior. Guidance is purely on a singular day. We are seeing consistent behavior over a long period.

QUOTE
The order forms part of a trading pattern where the client or trader regularly chooses to buy high or sell low at the close. This may be a reportable matter where the order would, if executed, represent a significant increase or decrease from the previous trade price (‘price support’, ‘marking the close’ or ‘window dressing’)
Other indicators include:
 the client or trader chooses not to buy or sell at other times of the trading day when better prices are available;
 the client or trader is a substantial shareholder of the company invested in (Company A) or a related entity;
 Company A is the bidder or target in a takeover; or
 Company A is conducting a placement
In addition, the client or trader may already hold existing positions in Company A (e.g. as a fund manager), and:
 have an interest in maintaining the price of the shares at a certain level; or
 the order would have the effect of modifying the valuation of their position without materially affecting the size of the position


It is up to participants to decide whether Orders that they place on the market impact the integrity of the market.

As we know Shorting is considered by the regulator as a legitimate method of price formation and liquidity discovery.

ASIC does provide some guidance for Participants to consider on layering - one is as follows
QUOTE
These orders may be intended to create a false or misleading appearance of buying or selling demand (‘layering the order book’)
This may be more suspicious if the client or trader subsequently submits an order on the other side of the market. Once this latter order is executed, the client or trader rapidly removes the initial multiple orders
The market participant may be aware that the client or trader is a substantial shareholder of Company A, or may otherwise have an interest in supporting the share price of Company A
The pre-auction period is a time to be particularly vigilant of this conduct


While aspects of layering exist here, it would be fair to say that each order is Bona fide in intention i.e. they are not removing them and are happy to buy or sell at that price.

More than likely there is a group or groups of funds on both sides. Potentially using multiple participants but clearing through a singular custodian.

ASIC has a very impressive amount of market data available for them to analyse post trading.
Past indications are that they will not see this activity as impacting the Integrity or the Fairness of the market.
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polyphemus
Posted on: Oct 11 2019, 03:56 PM


Group: Member
Posts: 532

Good points. CUV already had to buy Singapore out to gain 100% control. We lost equity on that wonder. Hopefully they have realised that IP should stay in house.

Management has toned down their presentations aggressiveness on the matter from March 2019 -
QUOTE
4. Evaluating inorganic growth opportunities

- but buying unlisted companies is an extremely efficient way of creating growth due to the different multiples applied to Listed vs un Listed businesses.
What generally occurs in these situations is 1st to market hoovers up potential competitors due to the more effective use of capital.

There are always supply chain considerations on how to deliver. VLRX001 will be topical applied as a maintenance therapy for Vitiligo.

The business growth path - is currently stated as finish Vitiligo and then move to greater population. That will require a distribution capability.

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polyphemus
Posted on: Oct 11 2019, 02:32 PM


Group: Member
Posts: 532

I think we need to wait for the AGM on time lines and next strategy from the Company. I still want to see what Singapore has on its agenda - I know the patent details which are very encouraging.

CUV also appear to be seeing organic growth in Europe due to roll out of centres, word of mouth (associations and conference), education and a likely potential UK access.

Australia / Japan 2020?
Certainly submitted 2019 but approval is up to the Regulator. Aus TGA has a Priority Determination process, Scenesse is considered an Orphan drug development circa 2010
Japan is interesting
QUOTE
However, the penetrance of the EPP phenotype in the Japanese population is expected to be higher than in the Western countries due to the high frequency of the IVS3-48C polymorphism (43%)

- I don't know much about their processes but they certainly have a large unmet need Attached File  2019.EPPinJapanActa.pdf ( 593.29K ) Number of downloads: 46


Nasdaq 2020? Yes but after a Corporate acquisition or two. CUV may need to capital raise as well depending on how many indications they target concurrently. I would not want to see a listing with only 50mil in shares issued. Just not enough to go around - Perhaps raise capital with a rights issue 1or2:3 underwritten with a Private insto placement of 10 mil - say $40AUD to raise $1-2B to fund the next phase. PW may not want to give away management control by letting more shares out that he does not scoop up - so potential debt instrument - Corp Bond/ Conv Note.

Vitiligo 2024? I would think 12 month phase 3 2020/21, 3rd/4th qtr 2022 acceptance.

Variegate Porphyria 2025? VP should go into Phase 2 2020 late - I cant see how they could do a large Phase 3 with the low incidence. With the experience of EPP Ph3 and a successful Ph2 it would be 2022/23

Paediatric 2026? I think Singapore can do more now - they will have a larger budget to spend they should be able to either shrink the implant which is not kid friendly or get some topical formulation going that parents could use on the infant until they are large enough for a form of implant. The ethics on this will be tough
QUOTE
Paediatric population
The European Medicines Agency has deferred the obligation to submit the results of studies with SCENESSE in one or more subsets of the paediatric population in erythropoietic protoporphyria.
  Forum: By Share Code

polyphemus
Posted on: Oct 11 2019, 01:46 PM


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Posts: 532

Naked Shorting in Australia has a couple of waivers but generally speaking is against the Corporations Act Law
However Covered shorting by Hedge funds occurs by borrowing the stock from Custodians of shareholders.
Personally I think Custodians that lend for Hedge fund shorting, are performing an unconscionable act, directly against the shareholders best interest.
The argument and recognition by the Australian regulator ASIC, is that Shorting is a valid mechanism of price discovery and liquidity.
I disagree of course
- I believe only exchange based products should be allowed to short exchange based assets i.e. options, futures, warrants. Those market making participants would need to Covered short to hedge their risk. I would include Bear ETF's in the mix.
- Hedge fund shorting creates an unfair market and destroys liquidity by slicing parcels into non economic portions that moves markets by % on low volume.
The same can be said for all Algo based trading, however Algo buy and sell based on genuine ownership does make the market more efficient - the only problem is Retail do not have common access to these tools which makes it an unfair market.

For example - does the below show true liquidity - are these genuine or just the illusion of liquidity and price formation
Attached Image




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polyphemus
Posted on: Oct 11 2019, 07:45 AM


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Posts: 532

Quick thanks to everyone on the board, the info is great.

Morningstar quant Attached File  0P00006WE1__5_.pdf ( 116K ) Number of downloads: 461
appear to think current Fair Value is $55.24 - their high to low range is $23.52 to $129.74.

I have never understood Morningstars quant work or why it would change purely based on share price movement. Previously they have always been a laggard forecaster.

Happy, that Sphene were 100% accurate after copping shade from PW. We should see a few more insto analyst reports starting to be initiated and with all the same price targets.

In 10 years with $1B-$2B in revenues this company will be $800 to $1600 per share.

Best return for Shareholders is to keep CUV as its own entity.
  Forum: By Share Code

polyphemus
Posted on: Oct 2 2019, 09:53 AM


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I see it as good news. Positive outcome on the 8th US time. Wednesday 9th the company can move on.

No more delays.
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polyphemus
Posted on: Oct 1 2019, 09:37 AM


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Posts: 532

I would say your delay chances are a little high considering past FDA behavior. Initial PDUFA was 8th July. Extension to 6th October came out on the 31st May - 4 weeks before the date.
Suggests that the FDA thought 3 weeks ago that they had the a complete NDA.

The FDA did not need an advisory committee with this application - I believe the real world data and the FDA's 2016 EPP workshop view may already be set
QUOTE
FDA shares the patient and healthcare community’s desire and
commitment to furthering the development of new safe and effective drug therapies to treat or prevent EPP.


Safe and Effective being the key words.

With Post Marketing commitments due on the 6th Sep - I would assume these are conditional until approval
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polyphemus
Posted on: Oct 1 2019, 08:25 AM


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Posts: 532

There are no reasons for the FDA to reject a new drug that has been in use in Europe without incident for five years.

The US EPP patient population has made it abundantly clear regarding the benefit of the drug.
Discussing efficacy. Yes the phase 3 trials were positive and US citizens are flying to Europe to get access regularly at their own expense for many years.

Side affects are insignificant with no new issues coming to light in the last five years.
Again the FDA has all of the Post Authorisation European data. They are fully aware of patient benefit and patient risk.
Can the drug be misused by patients?
No - the point of physician injectable delivery of a pellet that release correct dosage over time avoids direct patient misuse, avoids distribution to non patients.

There was one question regarding ensuring manufacturing quality of the pellet. This question was asked and resolved.

The FDA will approve.
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polyphemus
Posted on: Sep 30 2019, 12:20 PM


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Posts: 532

Should be a good couple of weeks. I forecast price appreciation and potentially a new high in November.

At this stage of the regulatory process the following is not advice - on buying/holding/selling shares in this company - it is a view only.
FDA acceptance is important as it de-risks the company further. It 100% legitimizes the indication EPP has benefit from scenesse in the US.
Japan and Australia regions would follow without too many distractions based on both EMA and FDA analysis and real work experiences.

The current price is an aberration on the negative side by market forces that are not fundamental or actioned by shareholders in the company.
Even morningstar thinks the price is 20% oversold.
If you review the Mar 19 Sphene research and 12mnth target of $58.40 AUD is still valid. The only issue with that research was they were 6 months aggressive on time lines.

I would suggest that FDA approval will see further Research analysis from brokers with ability for further funds to buy in.
1st Quarter sales are due at the end of October which should see a increase YOY due to continued European roll out.
We find out Company strategy at the AGM which should be the statement of continuation of Vitiligo and VP.

Attached Image

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polyphemus
Posted on: Sep 23 2019, 03:55 PM


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I expect earnings of closer to 60c per share this year, just based on FDA approval with Jun quarter in sales, plus a larger than expected growth in distribution in Europe.

That puts the stock price at AUD$40-$50 with conservative PE ratios.
I believe any short fund would be expecting a stock specific fall on approval due to exaggerated expectations. As we know that is not how this stock trades.

FDA approval will give a rise in sales greater than 100% on an annualised basis and also will trigger to new market applications Japan and Aus. That is the fundamentals.

The real share price growth will be R&D based expectation, releasing the Kraken of $50m in cash + $30m pa cash flow on hand into new market and product.
The new market and products strategy will be a huge part of the annual general meeting this year. If management come up with an Squiddly Diddly plan then the stock price will suffer.

The current Benefit to Risk question is already answered with only supply chain risks and distribution execution risks will be known after approval
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polyphemus
Posted on: Sep 20 2019, 01:21 PM


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Posts: 532

As a reminder of current EPP patient experiences which have probably been linked to before but they are real people real experiences that should get a result on the 6th October:

Coming out of the shadows: A new treatment may help people who are allergic to the sun

Patient empowerment and access to medicines

A journey to successful protection with Scenesse
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polyphemus
Posted on: Sep 11 2019, 01:50 PM


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10% drop over two days with no material news. Should be close to triggering an ASX Price query today.

Response should be similar to:
We respond to your questions as follows:
1. Is CUV aware of any information concerning it that has not been announced to the market which, if known by some in the market, could explain the recent trading in its securities?
CUV is not aware of any information that has not been announced to the market which could be an explanation to the recent trading in its securities.
2. If the answer to question 1 is “yes”:Not applicable.
3. If the answer to question 1 is “no”, is there any other explanation that CUV may have for the recent trading in its securities?We refer to pending PUDFA update which may create speculation.
4. Please confirm that CUV is in compliance with the Listing Rules and, in particular, Listing Rule 3.1.CUV continues to be in compliance with the Listing Rules and, in particular, Listing Rule 3.1Confirmed.
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polyphemus
Posted on: Sep 4 2019, 06:03 PM


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It looks like financials are starting to flow through to analyst systems. Morningstar quant which I have never understood how their algorithm works has had CUV as undervalued which is a switch from their opinion the previous month. Today they were coming in at $36 AUD. I assume aud $ currency dip is the reason from the raise of value from $32 and last years final financials are the reason for the valuation rating change.

Attached Image vs Attached Image
On the positive front insiders such as directors buying more ADR's is indicative that to management all is proceeding as normal.
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polyphemus
Posted on: Aug 23 2019, 04:23 PM


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I think profit will be $33m with a 3.5c div.
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polyphemus
Posted on: Aug 15 2019, 04:04 PM


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Yes I have cash and am on the side line, but getting antsy with the marketing requirements coming up in early September.
I would like to see a couple of days with negative shorts. That would signal capitulation.
The price would have bounced of lows but i would prefer to miss the low to avoid catching a falling knife.
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polyphemus
Posted on: Aug 15 2019, 03:06 PM


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Yes naked shorts can be very dangerous. I worked with a group that had bought 110% of equity in an aussie listed company last century - clearly should not happen, the group got very rich. Same thing happened to Volkswagon in 2008 "Short sellers make VW the world's priciest firm" (Reuters 2008) .

Shorting pollutes natural Demand and Supply mechanisms. Swings can be wild.

Australian law is quite specific on the naked exceptions RG196 (ASIC 2018)

As there are no ETO's or Warrants on CUV it is fair to conclude that the bulk of the shorts are speculation vs say arbitrage advantage between markets. I smell opportunity.

To use the analogy of shorting printing extra CUV shares then there are 105% of capital in CUV shares out there.
How much can they borrow to support their view...?
There should be a profit to be made from a medium term trade here or sitting with a sell order at a ridiculous price waiting the irrational exuberance on buy back.
There are 2.5m shares short @9th Aug. Daily avg volume is 276,000.
Ten days of trading to cover positions and as daily shorts are between 30-50% of volume, it will take a good month to buy back.

There are 2 up coming realities possible -
1. FDA approval which means significant revenue growth in 2020, $50m in cash will be pushed to Vitiligo Phase 3 trials or
2. FDA not approved which means only double digit growth in revenue. $50m in cash will be pushed to other endeavors such as topical I.P, XP / VP Europe.

The company does not need cash, it is not going bankrupt and has zero debt. It has cash and has a recurring revenue source. If FDA approval that recurring revenues jumps to ~$30m + in 2020 and ~$50m from 2021 after tax. That is no requirement to raise capital for Vitiligo. If non approval then recurring revenues would grow by low double digit 2020 and 2021 - but as the other indications are orphan the expense of trials would be less. That is no requirements to raise capital. With a mid term view the company would appear to be a low risk investment. Yes they should pay dividends.
With Topical formulations management has as yet to describe what markets that would be in and just as importantly how long that would take to generate cash flow. As for statements on organic and non organic growth it would be nice if management could elaborate more at the GM.
QUOTE
•Translational use and growth
•Orphan indications and pigmentary disorder vitiligo (skin types IV-VI)
•2ndgeneration melanocortins �"Rx
•OTC products for larger audience



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polyphemus
Posted on: Aug 15 2019, 09:02 AM


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Posts: 532

Sorry i dont have access currently to unmasked data - as there is 5% short it will all be Insto that have access to large nominee pools of stock they can borrow. Generally the only naked shorting in Australia is from market makers hedging risk, but this still requires stock lending to cover post transaction.
I generally speaking have a problem with Nominee groups contributing to activity that is counter to the interest of the owners of companies. The benefits of liquidity and reduced volatility don't appear to be realized - shorts tend to increase the magnitude of volatility in both directions. The only shorting i would like to see is by listed Exchange Traded Options, warrants and futures by market makers of those products.


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polyphemus
Posted on: Aug 12 2019, 09:53 AM


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Posts: 532

I agree with the apparent bear trap - 19th June with an exuberant price at $38.95 and 0.58% shorted (279,342) we end up at 5th August with $28.73 and 4.54% (2,183,141) short.

But there will be more pain, August is a good month to short a stock like CUV. No news expected + risk with the FDA.
Not much to do about that except for review the reasons to invest in the stock.
Final report and Q1 2020 will not be out until October, 2019 results are not built in, 2020 are not given guidance to the market. Re read the Q4 4C report, 2018 Annual report and review the Vallaurix patents in my opinion.
The financial health of the Company is stella.

Accountants do a better job than me and I would expect 2019 profits to be slightly larger than the $18,382,000 positive cash. You can see the same results from 2017 and 2018 with non sales revenues impacting bottom line. I expect tax credits to continue into 2021. You can also see employee expenses (Staff + Corp costs) went up in 2019 but by less than manufacturing costs.

Attached Image


2019 EPS est = $0.375 , 36% increase
2019 NTA per share est =$1.11 ,35% increase
Q1 2020 expense est = $5.46m , 53% increase YoY Q1
2020 Sales est = $16.3m in line with a 56% increase on 10.7m Q1 2019

2020 EPS est low = $0.59c high = $0.81 2020 NTA per share est between $1.70 - $1.90
Current share price $26.86 AUD
PE = 71.54
2020
PE low = 45.5 ,high = 33.13
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polyphemus
Posted on: Aug 1 2019, 09:39 AM


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Posts: 532

QUOTE
Cash Receipts for the quarter were $13,010,000, an increase of 121% on the March quarter 2019 ($5,898,000) and 25% on the June quarter 2018 ($10,388,000). Financial year-end Cash Receipts to June 2019 of $32,221,000 were up 36% compared to the prior financial year (to June 2018).

The next phase for the company is still growth in revenues.

The FDA decision is a risk in that process. Statistically though the chances are very high for approval.
We are not as familiar with the US market size (Sphene analysis suggests 2.3x greater), and the same can be said for Asia Pacific markets (Sphene; 0.25x Europe). Sphene has been very accurate to date on value and risks and price targets. The analysis was too optimistic on timing of FDA progress and Europe market increases.

2019/20 Expectations for Europe would be same rate if growth in market ~20%-30%

Removing $700K in Exchange rate benefits the numbers are indicative of the current continued growth in the European market.

Post US market inclusion - 2019/20 revenues would see 4th quarter US sales of $13m on the low side and $30m on the high side. Bringing overall revenues up between 50% and 100%. 2020/21 revenues would increase a further 60% for a full financial year.

However expenditure will increase with a FDA approval for EPP, as the go decision for secondary indications and trials is given. The need for a Capital raising to cover costs appears negligible with cash receipts and cash on hand well able to support future R&D expenditure. Just not sure of any operational benefit of a NASDAQ listing. Would have further liquidity benefits and also could be used for unknown CUV projects that management may wish to progress. Debt is cheap if required. The estimate revenues on Vitiligo even at a $5K treatment cost are close to block buster level.
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polyphemus
Posted on: Jul 25 2019, 12:01 PM


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Posts: 532

Yes - PW will become Chair when Stan retires on US FDA completion. PW is good for novel indications to market and also increasing market size. Once approved a degree of freedom will be allowed to progress the other indications in which a different mindset is required regarding risk. PW will be too busy on other priorities. Stan has been great in supporting the team through the frustrating delays of a new mindset in medicine. His CSL back ground did pay off in the end which hopefully the company will continue to emulate.
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polyphemus
Posted on: Jul 3 2019, 10:44 AM


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Posts: 532

As usual the various research groups are behind in the financials they use, giving variable EPS results based on methodology (earning period or number of shares on issue).The ASX appear relatively accurate as you would expect of the listing exchange.

Attached Image

My numbers are a based of the quarterly 4C Comparing year on year, 9 months (ex June), July 17-Mar 18 vs July 18 - Mar 19
Sales are up 44%, $13.3m to $19.2m, Earnings are up 130%, $4.2m to $9.7m.
It is worth noting the woeful December 18 period which I factor was due to stuffing all the sales into September.
Comparing a rolling 12 months, Sep 17 to June 18 vs Jun 18 to Mar 18
(That is both periods have the larger Jun 18 period of $10.3m in sales vs Jun 17 of $6.2m)
Sales are up 25%, $23.7m to $29.5, Earnings are up 47%, $11.7m vs $17.2m

Using management's April guidance of
QUOTE
Treatment continuation >95%
we can forecast a conservative Jun 19 quarter should be less than Jun 18 or $9.8m.
(Ignore the obvious possible massive growth from manufacturing costs scheduled to increase 60% last quarter - that is probably US FDA requirements)
Very conservatively then;Sales should be up year on year $23% to $29m, Earnings should be up 35% to ~$16m or 32 cents per share

Any greater earnings above these numbers and I would be very happy
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polyphemus
Posted on: Jun 28 2019, 09:44 AM


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Posts: 532

Today is the last day of tax selling for the financial year in Australia. There is always a bit more downward selling in June which gives larger volatility to an already volatile stock.

CUV finished at $11.01 AUD 364 days ago. Then did nothing in July with a bounce when financials were posted pre July 31 but drifted again into August. I would suggest that any sign of good earnings increases year on year will drive the stock to the Sphene reweighted target.

I think it is time management started detailing future expected revenue projections.
Management have been monitoring this seasonal variability for 3 years and should know what to expect. This is a ~$2B company with sales, it is not unreasonable as a shareholder to get guidance.
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polyphemus
Posted on: Jun 7 2019, 10:26 AM


Group: Member
Posts: 532

Basically removed company back ground and light spectrum slides from April's presentation and replace that with 4 relevant points when discussing scennesse

Alpha-MSH:
1. anti-oxidative
2. melanogenic (activates epidermal melanin production)
3. anti-inflammatory
4. DNA reparative, photo protective

All in all a more focused presentation on [SAFETY], better financials provided (growth in EPS and US p.a. treatment cost USD$96,000) and added a snippet for merger and acquisition in the summary.



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polyphemus
Posted on: May 17 2019, 10:29 AM


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Posts: 532

Your right - US probably do not care too much about a the ASX200 Index - Clinuvel is in New York to present at 10.30 am on Monday (US time) at the UBS Global Health care conference.
Will the presentation change from the Goldman conference 7 weeks ago? Probably not - maybe some details on FDA progress.

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polyphemus
Posted on: May 17 2019, 09:31 AM


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Posts: 532

We saw the same volume increases leading up to the 300 index inclusion.The security is only getting institutional coverage now which is an easily speculative buy, and do not under estimate Morningstar analytics indicating undervalued below $33.50 - if theirs comes with this value then other groups will also becoming up with the value.

But the big news is when an insider buys more of the security, USD$50K - it gives the impression that internally all is looking good.
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polyphemus
Posted on: May 14 2019, 10:46 AM


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Posts: 532

Morningstar report appears to have changed it's valuation - as you can see the detail in the report is a little sparse. I take it that they are purely based on momentum analytics.
Usually they would have the security fair value 30% behind current price.
They appear to now be in line with the consensus.


Attached Image

Attached File  0P00006WE1_1_.pdf ( 114.38K ) Number of downloads: 92



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polyphemus
Posted on: Apr 30 2019, 09:42 AM


Group: Member
Posts: 532

QUOTE
Net Cash from Operations for the nine months to 31 March 2019 was $9,764,000 compared to $4,253,000 in the same period to 31 March 2018

Cash flow is king - and they indicate June and September quarters are where the revenue comes in. Maybe a double in dividend this year.
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polyphemus
Posted on: Mar 29 2019, 10:23 AM


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Posts: 532

Just had a look at the action on the 20th, my theory was a bust - looks like multiple sell pressures triggered multiple algo's to attempt a VWAP that was dropping. I base that the bulk of these were algos due to the transactions being irregular parcels
The crossing was a broker LiquidNet but analysis just shows a transfer of the block and no other activity.
The selling activity through the flash crash was quite varied Bell was the broker that had a legit order that pushed the stock to $29.
If I review every trade from the crossing to 12.05pm. 733 transactions Starting at 29.23 going to $22.24 @12.05:30, total units 60067.

There were 385 sells that initiated the transaction, 201 buys that initiated the transaction - 147 are the result of the initiation.
Sum of Units
ASK 35749
BID 21460
(blank) 2858
Grand Total 60067

Using this as the bases then, there are 22 brokers transacting all up but the sellers were
Attached Image

review of activity for the month does show specific Buying and Selling patterns from the Insto book. Although 1 group does stick out as selling. I think ASIC would have trouble issuing a please explain but their analysis will be far superior to mine with the amount of data they have.
Attached Image
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polyphemus
Posted on: Mar 20 2019, 01:30 PM


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Posts: 532

The Communique is very interesting. Suggests a high state of confidence in growth and FDA acceptance

Page 1. Summary the team is working hard across the globe to get responses in to the FDA in a timely fashion.

Page 2 - they have started selling in Europe after winter hiatus. they have noted some EPP users require protection in winter. They are growing and need extra staff to monitor
"In the meantime, we are expanding our team of clinical monitors and liaison managers inEurope, very much a function of growth of the Company. These staff facilitate the capture and monitoring of data under the marketing authorisation,"
"The challenges this year are to manage the expansion of supply"

Page 3 - more growth. If they are presenting to four banks will they be adjusting the current presentation or using the old one. My guess is we could see more buying pressure come 2nd week of April.
"The time prior to FDA outcome is opportune, since it provides us the ability to share our next phase for the US supply of SCENESSE®. "

page 4 - confidence of FDA approval
"much value is attributed to the key European managers in our team who are soon endowed with the responsibility of executing in the US. "
"... our team has turned its attention to the challenges of a US roll-out "
and they seem very happy with the 1st half of the year.
"six monthly financial audited results – the half year ending 31 December 2018. The results have exceeded our expectations year on year"
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polyphemus
Posted on: Mar 20 2019, 01:13 PM


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Posts: 532

I dont think it was a coincidence that we saw a S3 crossing for 51,540 at 11:31am and then saw selling pressure from 11:53am with the subsequent selling transacting 499 times between $29 and $22.25 for 52,684 units. My guess here is that the asset was transferred, the new order was given to the book, the Algo selected appears to have been hyper aggressive and they exited the position.

If the exchange does do a please explain it will be on the executing broker on whether they maintained a fair and orderly market.

Stock is currently at 26.69/26.70 spread
Attached Image
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polyphemus
Posted on: Mar 18 2019, 09:58 AM


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Friday - ASX crossed at 16:10:44 Couple of large specials were then book on CHI-X for 72,810 - finally a couple of late Portfolio transactions occurred on ASX and CHI-X.
If I were showing day traded volume in a system I would cut of at the listing exchanges close to have a more reflective day change for price and volume. That's just a philosophical view point not a rule. But there is no reason why these could not be put into daily volume calculations, however there is no guarantee the price transacted at will be similar to the market. Special Transactions can be like placements at pre-agreed prices. CHI-X market also trades a little later than ASX random post 4:10pm, to 4:12pm fixed time for clean up purpose on Brokers day books.

Attached Image

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polyphemus
Posted on: Mar 8 2019, 10:29 AM


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I was a sure thing man. Now it is just stupid that two penny stocks get inclusion. They must have had greater liquidity.
Goes back to the Index low turnover policy.

Attached Image




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polyphemus
Posted on: Mar 4 2019, 08:33 AM


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CUV will be asx200 constituent this Friday. Its just another step. And if EPP in US occurs in July this time next year it will be in the top 100 index.
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polyphemus
Posted on: Feb 28 2019, 08:48 AM


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Posts: 532

My systems show 153,504 as short. Generally I would say short positions such as these were the reverse side of a derivative. As there are not ASX or CHIX Warrants or ETO's direct on the security I would think that either a short index fund or CFD's may have a short position out there. possible though that it is simple arbitrage across borders which have to be reported as short on ASX.

Which brings up another benefit of ASX 200 inclusion and a rampant share price.

Warrant makers and ASX ETO's will probably get initiated which will allow people who are long to start capping some of their risk by taking a Put option or Put Warrant.
Call it a type of insurance. Those investor that can not come up with the $30 plus for a low dividend high growth stock will be able to take out long dated call Warrants and options and either take capital profit or treat it as an installment buy when the security switches to higher dividend payments.
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polyphemus
Posted on: Feb 18 2019, 02:19 PM


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There are 4 types of market in Australia - DS just means data source. There are the 2 visible markets ASX Trade Match ™ and CHI-X (CXA) exchanges.
Then the 2 exchanges have hidden liquidity markets (ASX Centrepoint / CHI-X HL - you wont see that depth in visible).
Then the final type are Dark Pools run by Brokers (but they have very specific rules that are used to execute)
The DS just means ASX ™ lit price, CHIX (CXA) lit price or a mix of ASX and CHI-X lit price - also referred to as NBBO, National Best Bid Offer.
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polyphemus
Posted on: Feb 18 2019, 10:44 AM


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Posts: 532

10 more cents and we hit the all time high again

No point fighting the trend - will be $25 this week. Based on... no idea but don't care. Volumes are too large for simple irrational exuberance


Attached Image
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polyphemus
Posted on: Feb 12 2019, 08:49 AM


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Posts: 532

Trade volumes by exchange on the 11th - Specials are done off market and reported by the broker

Attached Image
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polyphemus
Posted on: Feb 11 2019, 09:38 PM


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Posts: 532

The strength of this stock and strong volume has me a bit bemused at the moment after a negative cash flow quarter. Just should not be happening.
Sure getting inclusion into the S&P ASX 200 premier index will add to the buy side. That though is March.
But surely if you are a index fund you have no mandate to buy until after the inclusion - so they can not be buying now.If there was a positive US FDA outcome - its not about the potential double in revenue - it will be more about the future 10x revenue once funds are released by management for further trials (apply a future cash flow concept). But that would be a bet on a positive outcome, that does not hit until July.
Getting a NASDAQ listing while nice for exposure, would really be about potential capital raising to fund expansion, but that has to be based off FDA approval. No point being in the states if the company is not expanding.
It is nice to see tweets and statements on topical melanocortins but there is no time line or product and addressable market statement. R&D fell last quarter and bugger all this quarter. I assume these are the over the counter style products that are expressed on the website but never said, like dietary aids, inflammation regulation, sexual function.
Inorganic growth i.e. acquisition would send the stock price down unless it was buying knowledge. The company should not acquire pre FDA as the risk parameters should be too large and cost of finance (which apparently is monitored daily) to expensive.From what I understand (which from the above is little) the company has purchased some software to track financial reporting. That is no reason to buy more of the stock.


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polyphemus
Posted on: Jan 31 2019, 08:50 AM


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Posts: 532

Yep not real good - 1st negative cash flow for a while

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polyphemus
Posted on: Jan 29 2019, 09:49 AM


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There are 26 companies in the S&P ASX 200 that are below $1B in mkt cap, the bottom 9 are below $700m

The S&P ASX 200 Index is a low turn over index - a few of these companies should have been removed based on entry criteria, however entry criteria is not exit criteria - so companies obviously remain within even if they could not pass entry criteria at a point of time.

There are 7 companies in the ASX 300 with greater than $1B in mkt cap, 3 of which will never qualify due to capital structure. (CDI, Stapled Security, International Listing) The majority of companies have similar free float issues.

CUV ranks at the bottom of the rest and is on the back of a 6 month uptrend.

Stock Last mkt cap
NWL 730 $1,735,062,664.10
PME 1265 $1,310,748,952.70
FNP 506 $1,239,059,657.00
CUV 2184 $1,045,218,414.24

March 2018, there were 4 new entries into the 200, Mar 2017 No changes, Mar 2016 5 new entries.
CUV has a reasonable chance of gaining entry in to the S&P ASX 200, however I think this quarter's revenue will be the determining factor impacting mkt capitalisation which would need to maintain post the $1B mark.

Net Cash flow of $2m would be a good result on receipts $5.5m. AUD vs EUR is down 5% year on year so that should assist. Some of the numbers stated on board with increase in revenue would catapult the price to the current target of over $30 as projections of future cash flows amend (i think you're dreaming on that but the Sphene analysis had similar expectations so your not alone.)
I do note the the expected Production manufacturing costs are expected at $1.3m vs $0.7m from the previous year.
But this looks like it will be paying for the distribution increase in Jul-Sep 2018.
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polyphemus
Posted on: Dec 13 2018, 10:22 AM


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Looks like the crossing for 38K on monday was by a Broker called Evans and partners - they do have an insto desk but are more aligned to high net wealth clients. They are about the a 16th the size of Deutsche, Morgan Stanley, Citi to give a comparison (in Aust)
1st hour of trading today has again been dominated by algo's - definitely being pushed on the buy side. sell side resistance appears to hold less volume. Check the spread - 5% between bid and offer, which is the frustrating thing with low volume stocks being traded with small parcel algo's. Again no idea by the market of what is a reasonable valuation for the company. You have to do your own modelling - come up with a price. I tend to agree with the Sphene analysis - it is in depth and consistent and has outcomes that I suspect are valid, but as we know time lines better here, they may be optimistic which would just push the revenues by 3-6 months. which means I think the DCF is slightly aggressive but I 100% agree with a >$30 value. I think anything under 20 on the price to NTA is cheap for this stock. Over 25 and you best start reviewing how close we are to future cash flow. (Yes I hold a position in this stock and my views are skewed in a optimistic positive lens.)

Sphene Update
Sphene Initiation

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polyphemus
Posted on: Dec 10 2018, 11:58 AM


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Agree - I think obviously though if it was $24 we would not be saying it was a great price. The stock has had a large seller pushing for months now, but the last couple of weeks has been general sellers as well with no forward news to roll into future cash flows.

Today we had a special crossing 38,861 units at $16 - part of me hopes that it is the final piece from the above seller and part of ,e is worried if it has been pushed to a broker facilitation account to close the order.
Not that we saw any cessation of algo related sells post that.

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However while it hurts, I am not trading the stock at the moment. I may buy some more the NTA is under 20 which considering potential growth forecasts is low.

It would be nice to get that 3rd indication
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polyphemus
Posted on: Nov 28 2018, 08:38 AM


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Trading this month has been sideways - very similar routine each day - open high or low then watch the algo trading kick in and drive the price away from open. From observations there has been no real hard buying or selling. Its is hard to get any price formation or clue to value with $1 swings between high and low each day. Yesterday was slightly different - algo trading waited until 11:10am to start. usually see the activity a few minutes after open 10:05am

Quite annoying with an average trade value of the larger players of $500 per transaction or basically 30 units per transaction. Macquarie and Goldmans are at 12 shares per transaction.

The up shot is if you are buying don't chase let them come to you. If you are selling looking for afternoon rebounds.
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polyphemus
Posted on: Nov 28 2018, 08:26 AM


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While I wait for the ethical approval hopefully this month....it feels a lot like Tesla.

From the Nov Investor update
QUOTE
final protocol agreement with an academic centre[/b] which will conduct the pilot study in the third elected indication. CLINUVEL will announce this indication when all legal and administrative agreements have been completed. ]


A more detailed explanation of all that research that has been going on indicates supply chain improvements for the future:
QUOTE
We have surprisingly found that compounds of the present invention provide beneficial results in in-vitro and/or in-vivo tests for instance relating to MC1R binding affinity, potency, and/or efficacy or showing increased stability, and are in particular useful for increasing MC1R expression as a medicinal target. Further, we have found that compounds of the invention can safely and efficiently be synthesized, particularly at high yield.


3rd indications lead into the 4th and 5th ... from the patents there is a long expression of possibilities. But they need to get into the 1st round of trials
QUOTE
Preferably, compounds of the invention are used for treatment of diseases wherein the compounds -through association- beneficially increase MC1R expression, as a drug target for the diseases. Examples of such diseases are pigmentation disorders, photodermatoses, prevention of skin cancer, and/or DNA repair in skin cells (after/due to UV exposure). It will most certainly be understood by the skilled person that the disclosure of this specification includes the use of each specific compound of the present invention for each specific of the indications mentioned.

In one aspect, compounds of the invention are used for treatment of pigmentation (or skin pigmentation) disorders. Such disorder can either be hyperpigmentation but in this case particularly hypopigmentation disorders are important. We have found that compounds of the invention can induce melanogenesis and are useful for inducing therapeutic melanogenesis.
In an aspect, the invention relates to inducing melanogenesis in the skin as a treatment for pigmentation disorders with a compound according to the invention. The term “‘melanogenesis” as used herein is defined as the ability of a subject to produce melanin by melanin-producing cells called melanocytes, for therapeutic purposes. Examples of producing therapeutic melanogenesis are protecting the skin from UV irradiation damage, for instance preventing the skin from developing wrinkles, sun burns and/or cancer.

An important preferred example of a hypopigmentation disorder is vitiligo. Vitiligo is a chronic skin condition that is characterized by loss of pigment, including melanin, resulting in irregular pale, de-pigmented skin that has a different color and aspect than and contrast with the surrounding non-affected, pigmented, darker colored skin tissue. In an aspect, the present invention is directed to treatment of vitiligo, in particular in combination with UV light treatment. Compounds of the invention are preferred for use in the treatment of vitiligo, particularly for repigmentation of vitiliginous lesions and therefore reducing the contrast between the vitiliginous and the surrounding skin tissue.

Photodermatoses are skin diseases that are associated with photosensitivity of the skin to UV irradiation and may be classified into 5 general categories: idiopathic photodermatoses (including polymorphic light eruption (PLE), actinic prurigo, hydroa vacciniforme, chronic actinic dermatitis, and solar urticarial-SU); photodermatoses that are secondary to exogenous agents (including phototoxic and photoallergic reactions); photodermatoses secondary to endogenous agents (mainly the porphyrias including Erythropoietic PhotoPorphyria-EPP); photoexacerbated dermatoses (including autoimmune disease, infectious conditions, and nutritional deficiencies); and genodermatoses.

In an aspect, the present invention is directed to treatment of photodermatoses. Compounds of the present invention are preferred for use in treatment of photodermatoses, particularly for EPP, PLE, and SU, most particularly for EPP.

Skin cancer includes melanoma and non-melanoma cancer. Generally, higher skin melanin levels are considered a measure for prevention of skin cancer. In an aspect, the present invention is directed using the compounds of the invention for prevention of cancer. Compounds of the invention are preferred for use in the prevention of cancer, particularly skin cancer including melanoma and particularly non-melanoma. While the general public will benefit from skin cancer prevention through the invention, certain patient groups will in particular benefit from the use of compounds of the invention, including immunocompromised patients (particularly HIV-AIDS patients, allogeneic transplant patients, i.e. the recipient receives the transplant from another subject, and/or patients on immunosuppressant medication), human subjects having one or more MC1R variant alleles associated with loss of or diminished receptor function (preferably selected from Val60LEU (V60L), Asp84GIu (D84E), VaI92Met (V92M), Arg142His (R142H), Arg151Cys (R151C), Arg160Trp (R160W) and Asp294His (D294H)).
It is understood that UV irradiation can cause damage to DNA, particularly the DNA of dermal (skin) cells. In an aspect, the present invention is direct to DNA repair. Accordingly, the present invention is directed to compounds of the invention for use in DNA repair, preferably in the skin, particularly subsequent to UV irradiation of the skin.
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polyphemus
Posted on: Nov 5 2018, 10:37 PM


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The news letter was interesting.
I could not help but laugh at the obvious bromance with the FDA. I think the two are obviously spending too much time together. They are diligent, under resourced and on a mission to protect the people. What's more the company can do more to help; "our suggestion of the US post-marketing program in EPP"
It just all ties in with all this social responsibility that both groups have.

There does appear to be a reason to think about re-weighing the companies prospects. I would suggest, too many questions and not enough information yet - but using the proxy pyramid of markets provided several years ago we can get the vibe of it. The pyramid is lacking the DNA repair piece and is the more conservative 2013 one.
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1. 90% chance admission to S&P ASX200 index in March 2019. Increased insto focus.
2. US EPP - high % chance of positive outcome in 2019 leading to a doubling of revenue in 2020 + initiation of Vitiligo ph3 trials.
3. OTC product line - what is that? over the counter or organ transplant.
4. I take it the new indication is something to do with variegate porphyrias or Hailey-Hailey disease which has already been approved orphan status. The others PLE, and SU I think we know require a lower risk to benefit. Or is the target Xeroderma Pigmentosum (XP)dna repair.
5. Is the OTC delay VLRX001 which was post vitiligo therapy use or the infamous CUV9900 topical formulation. Buying out the minority suggests VLRX001 is useful for more than just vitiligo. The IP Patents registered by PW in 2016 also targets that DNA repair and the "prevention of skin cancer".(generally in those people that have had a medical issue/organ transplant that exposes them to a greater chance of developing skin cancer.) So what does CUV9900 do?
All in all there would appear to be a solid chance of increasing revenue over the next two years by over $2 per share and increasing year on year after that.And then there are the Patents related to inflammatory disease filed in 2016 and neurodegenerative disorders filed 2017. Whats all that about? From a share price point it is about future opportunity.
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polyphemus
Posted on: Oct 28 2018, 11:38 AM


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The market down turn in Australia has radically changed the market cap of major listings.CUV ranks as the 202nd largest company by market cap within the ASX300 Index.There are 11 securities within the ASX200 with a lower market cap.
The entry criteria requires 6 months of Mkt cap + liquidity to be institutionally available. Would not think CUV will make the Dec reweight into the index but now see a high probability that the March 2019 reweight will occur and CUV added to the premier index.

My pet hate of Morningstar research actually has the stock at undervalued. Morningstar appear to just use algorithms that trail the market. The current value they have is $18.18 with a medium liquidity rating.
Means nothing to funds that just trace index flows, so we would appreciate an up day or two for the entire market.
I see the largest unknown pressure to be FIL Limited exiting the position. They ceased to be a major shareholder on the 12th September still holding 2.4 million shares so it is difficult to determine. The algo that sells is fairly rudimentary - basically places final orders $1 below last trade price at 4pm. I would think they have 1.2-1.4 million shares left.

The real stuff happens next week. We get this Fin years 1st quarter revenue (Tuesday or Wednesday).
Revenues greater than $3.5m should be considered an improvement year on year.
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polyphemus
Posted on: Oct 10 2018, 10:28 AM


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I saw the NICE result as positive. Clinuvel would be spending some resources but these would be minimal and it keeps to the Clinuvel mantra that the company has a social responsibility to address in EPP as the only effective treatment known.

Of more personal interest to me is DNA repair. I just treated some Solar Keratoses using a Aldara topical cream - the lesions created were large, painful and unsightly. Did the job though. The other option offered by the dermatologist was a cream that would turn my face beetroot red for a month which meant I would avoid all public contact i.e. to embarrassed.

If DNA repair can address previous UV based damage bring it on. If it is Topical vs subdermal even better.
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polyphemus
Posted on: Sep 19 2018, 02:13 PM


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We get ASX300 listing on Monday. That should give a little more demand and push the price.
Whether current prices are seen as fair value would depend on what you think DNA Repair is worth in cash flow.
Know more on that one in Q4, hopefully the AGM.

Next March I would expect that this stock will get ASX200 index listing. Requires a consistent market value over AUD$1B. The bottom 20 in the index are under a Bil$
ASX 100 List would require a consistent value of AUD$2-3B. That is probably a 2020 thing.
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polyphemus
Posted on: Aug 17 2018, 10:50 AM


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We should receive the preliminary Final report in 2 weeks (end of August).

2 weeks later I expect addition to the ASX300 Index (XKO) - with the other 4 Biotechs being CSL, Sirtex, Mesoblast, Monash IVF

Have to attach the index with CUV inserted as a text file - it should copy paste into a spreadsheet ok for review

Attached File  XKO.txt ( 31.72K ) Number of downloads: 306


I note several of the market data vendors I use, ASX, IRESS, Morningstar, Reuters, Bloomberg all have grossly incorrect information. I put this down to they must use annual and half yearly report for their information vs the quarterly reports. As we use quarterly reports we already know EPS was at 24c on Revenues of 48c with 73c in Cash assets PS.

Reported EPS was 0.149 for last year.

Any way - I assume that when the data gets changes of the random fair value ratings will change. I would expect that inclusion to the ASX300 will also spread the shareholder base a bit more.

Vendor PE EPS ASX 95 $ 0.120 Bloomberg 95.29 $ 0.130 Reuters 101.76 $ 0.120 IRESS 95.24 $ 0.126 Morningstar 84.62 $ 0.143 Poly 50 $ 0.240 From my estimation we are currently undervalued on an Asset basis by about 25-30% so I see this as a buying opportunity on dips
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polyphemus
Posted on: Jul 2 2018, 06:20 PM


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It was a special crossing - that is the transaction did not occur on the ASX market but was reported by the broker to the market.

On the app. Each broker will determine information that is displayed to customers about volume - generally off market transactions are not displayed as volume for the day, but that is not a rule.just the general consensus of approach..It is odd to see one of these reported at mid day.-

The off market transaction was performed due to the large quantity/value. of shares on offer aka 1.36 million would on current average trading volumes take 50+ days to complete. the $10 price point is the cost of exit. If we have a 5% holder buying they should lodge a significant change of ownership record in the coming days.
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polyphemus
Posted on: Jul 2 2018, 12:53 PM


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Large crossing today for 1.36m @$10 that should be the last of the selling pressure.





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polyphemus
Posted on: Nov 22 2017, 07:39 PM


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No chance of ASX 200 in December simply based on mkt cap - ASX300 is enough to allow funds to buy in - big Chance ASX 200 July 2018

The very signifcant break today was to punch through resistance at AUD$9 and backed by another large volume day.
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It will be $9.10 close tomorrow; expect the algo trading to fall apart - the gap is too large for the algo's to address in a rationale way, you can see the fake spread both buy and sell at 4pm today. The stock should open higher at $9.20
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polyphemus
Posted on: Nov 20 2017, 08:28 PM


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I have been happy with the 1st year of sales - a good profit.
Recently it is very pleasing to see liquidity turn up in this stock.
It just may be enough to get CUV into the ASX 300 Indices.
The market cap of AU$418m and the traded value today was better than the bottom 30 of the top 300.
CUV deserves a spot in the next re-weight (unfortunately March 2018) and then we can get some insto buyers and superfunds pouring in.

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Compared to other Biotechs in the 300, CUV would be the 4th largest by market cap. But if it had inclusion on the index liquidity would increase even more.
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polyphemus
Posted on: Aug 30 2017, 06:19 PM


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Good numbers thanks

also means future earning guidance is now required, also means we may start to get analyst coverage (Morningstar's 25th Aug report had fair value at $8.02)
165% revenue increase - do that again next year and profit will be $50m
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polyphemus
Posted on: Feb 7 2017, 07:53 PM


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I was hopeful that the security would be included within the S&P ASX 300 in March.
On strictly a market cap basis it would be in, unfortunately the turnover on market is about 6% of market cap.
There are 4 securities in the 300 with lower turnover, but they have larger market cap.
Purely based on market cap CUV would be 271 out of 300 based on today's prices.
So it has a chance just depends on how S&P will weight turnover into their liquidity calculation.

Health wise the company looks well placed for a $10-$15m maiden profit.
The quarterly report was still a 800% increase year on year and Jan-Mar income is historically larger than Oct-Dec
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polyphemus
Posted on: Jan 23 2017, 08:41 PM


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Bought some more today. I am pretty excited to see next weeks quarterly results. I expect about $12m in profit this year.

Anything less than $5m in sales will disappoint, I want to see the cash in the bank grow over $20m
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polyphemus
Posted on: Nov 24 2016, 07:43 PM


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The current selling Algo is Morgan Stanley, the current buying is Instinet - they like small slices. Other Algo users are Goldman Sachs, ABN, Credit Lyionass and ITG.
There is no liquidity in the stock so the algo has to use small slices to keep to the average traded value - nothing wrong with that.

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I was happy with the quarter results, I suspect I will be happy with the December quarter as well. It would appear that this year is the maiden profit. When I can buy some more I will, and this is all based on EPP which is looking like could earn a conservative $1 per share. I have not factored any other indications yet.
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polyphemus
Posted on: Oct 19 2016, 06:12 PM


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The quarterly will display organic growth. Anything below $1.7m will be a disappointment
We should get the annual report before this though which should discuss future plans
We potentially will see commentary from the FDA meeting with EPP patients
And then November should hopefully see a commitment to file a US NDA
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polyphemus
Posted on: Oct 4 2016, 06:28 PM


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Bought some more today, nice gain by the end of the day.

The stock missed the September S&P Index re-balance for the top 300 - that will put it at next March for entry.
It would have to double the share price to have a shot at getting into the S&P ASX 200 - but once there the usual buying pressure would be realised with Managed funds getting more of a mandate to buy the securities.

My purchase is just on optimism for the July-Sep results which will be published at the end of October. I want to see cash flow positive and judging by the price of treatment I think it will do that easy.
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polyphemus
Posted on: Jul 29 2016, 10:51 AM


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A$8.3m capital raising March 15 + Customer receipt A$1.235m +R&D Refund A$0.42m + Interest A$0.04m

I was pleasantly surprised on the upside for Receipts from customers. 50% increase quarter to quarter and 100% increase year to year

This gives great encouragement for a positive cash flow for this quarter.





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polyphemus
Posted on: Jul 28 2016, 09:17 PM


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Not so sure that there was a disruption with Italy - the no further subsidization statement on the 18th May I felt was more directed at the compassionate scheme for those in the Trial that has received the drug:
QUOTE
After completion of the clinical trial program, approximately 130 patients across eight countries (Australia, Austria, France, Germany, Italy, Sweden, Switzerland and The
Netherlands) received SCENESSE® free of charge


I would still think Italian patients for April-June qtr would be on the old rate vs the what ever rate is or has been now negotiated

Not much point over speculating - tomorrow will show the details smile.gif
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polyphemus
Posted on: Jul 28 2016, 06:23 PM


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Tomorrow is the quarterly results aka 4C posting - I would not expect a large quarter on quarter or year to year change, but I do expect it to be on the upside - say 10-20% increase

Receipts from customers last qtr was $821K, same period last year was $540K
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polyphemus
Posted on: Feb 3 2016, 09:28 PM


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Thanks Royco - sorry I have taken my eye of this stock while it progresses through bureaucracy. It is a little confusing but the minutes are the same as May 2015 for protocol version 1
QUOTE
A protocol for a retrospective chart review study comparing long term safety data and outcome endpoints in patients receiving and not receiving Scenesse, or having discontinued the use of Scenesse,


Versus the September 2015
In Sep 2015
QUOTE
Endorsement/Refusal of the protocol
The PRAC, having considered the draft protocol version 5 in accordance with Article 107n of Directive 2001/83/EC, endorsed by consensus the protocol for the above listed medicinal product.


The announcement following this should still stand
QUOTE
Clinuvel Pharmaceuticals Limited (ASX: CUV; ADR:CLVLY; XETRA:DAX) announces today that the European Medicines Agency’s (EMA’s) Pharmacovigilance and Risk Committee (PRAC) has agreed to a Post Authorisation Safety Study (PASS) protocol, allowing SCENESSE® (afamelanotide 16mg) to be released for the commercial supply to adult patients diagnosed with erythropoietic protoporphyria (EPP).


There are 170 pages to Article 107 with a very broad range of inclusions. It seemed like a fair and reasonable set of rules. A little onerous but with certain principle in place such as
QUOTE
(2)The essential aim of any rules governing the production, distribution and use of medicinal products must be to safeguard public health.
(3)However, this objective must be attained by means which will not hinder the development of the pharmaceutical industry or trade in medicinal products within the Community.


If the company does not issue a retraction from September - we are all good, and the revenue (unofficial and highly speculative) guidance remains.
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polyphemus
Posted on: Oct 28 2015, 05:47 PM


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Here are the brokers that have bought this month for what its worth - you can ignore anonymous there is a 3 day period of exclusion.

You can see there are a couple of Insto Brokers buying and two selling. JP and CLSA are really buying all volume they can get.
Any small algo trade will be ITG, any buy of 5000 will be CLSA...but the sellers are generally Commonwealth and not ubs. that is commonwealth will cap sell at 2.80 when ever they get the chance, in my opinion the commonwealth trading is also algo based as the orders hit in a sequence that is too quick for a human - once they run out the price will go north.
UBS sold earlier in the month and have not been seen for two weeks.
It would appear to be retail traders that keep selling into 2.75 but on the odd occasion the itg algo just could not help itself

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polyphemus
Posted on: Mar 22 2015, 05:00 PM


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Just an FYI - the S&P index change took affect on the 20th March. This will have a profound affect on the trading on this stock.
The large one off sale we saw the last week on the 13th was what apparently is the last of the sell side pressure. I could see 10/- at 3.85 and a floating 10/- at 3.60 on crossover. As you may have experienced this stock has low volumes and gaps pretty quickly. I would not be surprised to see it finish at $4.20 by the end of the week.
There are certainly more reasons to buy than sell.
My guess is that the Company will raise $20m in funds this year. There is no immediate rush with phase 2 Vitiligo still in analysis and unpublished, I would look at the wording within the presentations very closely to try and get an idea of mood of the scientific community. The company will need more money to continue with the trials - it certainly does not need to partner for distribution in a combination therapy solution, the distribution networks already exist, Clinuvel simply supplies scenesse which is easily administered inject-able product will no special skills required.
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polyphemus
Posted on: Mar 6 2015, 07:30 PM


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So S&P are putting Clinuvel into the All Ordinary Index. Better than nothing, but unfortunately the drop in share price kept it out of the Top 300. The company is now valued greater than ACRUX ACR though, which I always like to buy at its present levels. That said Acrux if it maintains its current valuation will need to be kicked out of the 300 and Clinuvel added.

So in April Managed funds will be allowed to purchase the security where there mandate allows All Ords securities (Top 500 Australian listed companies)

Whats it mean - I will be buying some more at these prices, anything below $4 is at the low end of the range, but of course ACR has fallen further so I may just use the tax play on that.

Either way dont expect any fundamental change until Fund Managers are allowed to accumulate next month
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polyphemus
Posted on: Feb 16 2015, 01:01 PM


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Thanks KRD to add onto your post:

S&P will re-weight early March for a late march change to Indices. They will follow up again in June 15.
This will be based on average mkt value over the last 6 months, and unfortunately for us liquidity which is small.
Should get a look in at a few indices, we really need to be in the All Ords which will be updated in March:
  • Index Name % Weight
  • XAO ALL ORDINARIES 0.010
  • XSO S&P/ASX SMALL ORDS 0.101
  • XKO S&P/ASX 300 0.010
  • XHK XKO 35 HealthCare 0.168
  • XSI S&P/ASX SMALL IND 0.117
  • XKI S&P/ASX 300 IND 0.012


Once included Fund Managers will be on Funds mandated strategy - which just means, they could not Buy the stock before whether they wanted to or not.
Once in the appropriate index it will be up for consideration for inclusion on the mandate.
This will be the ultimate factor that drives share price over the next 6 months, simple demand vs supply. Lets not kid ourselves about the size of the demand but it will certainly be better than the simple Retail punter we have now and small speculative funds.
Probably with a capital raising in the second half of the year once the security hits $7-$8 aud
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polyphemus
Posted on: Nov 10 2014, 09:19 PM


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As we have 48 to 88 days to wait for Marketing approval the share price is relatively well placed. I see this as another accumulate opportunity, this time with some confidence of longer term returns. As its a thinly traded stock, no point rushing at it, you just push the price up.

I would not expect any increase in sales until the European Spring, though if we get another large year on year increase we can expect a reaction to the price. I would expect expenses to increase though with new staff being hired.
Oct-Dec $587K
Jan-Mar $197k
Apr-Jun $923K

I expect some announcements on CUV9900 and other Scenesse indications.
Vitiligo phase 2 is enough to rally the price but a 10 month trial in Clinuvel speak means getting results around August 2015.

The real mover for this stock will be the weighting into the various indices on the ASX. Index methodology
I expect June 2015 the company will be added to the ASX200, potential ASX300 listing in March 2015. No fund managers can invest in the company so we get a situation where there is no depth and huge volatility. Get ourselves into the index and Fund Managers can invest. But before they are allowed in, time to accumulate on dips.
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polyphemus
Posted on: Jul 28 2014, 02:32 PM


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Interesting point. How can they fulfill Director duties here. We all know as stated on numerous occasions a belief of disconnect on market pricing of the company. We all know this is due to the 'news' exclusion rule regarding the EMA process. I agree I think $8-$10 would get more traction for a takover, personally I agree, authorisation by the EMA sets the value at $1B for the company based on Vitiligo potential.
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polyphemus
Posted on: Jul 28 2014, 12:42 PM


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Take over offer is interestingly opportunistic and a pleasant surprise. Forces Management to make recommendation which while complying with EMA protocol will give us our first real indication of what is going on there.

I can not see how management could recommend the bid at $95m if they believe that EPP has a chance of being approved. With a successful phase 2 on Vitiligo and 2 successful phase 3 on EPP in Europe, with the drug in use for multiple years in Italy and now Switzerland and a the last Analyst report pre Vitiligo trial data pricing at $3.14

My guess would be $300m is more appropriate and likely of success.

Opportunity that will in likelihood encourage other players with diminishing opportunity try and get on a new molecule with multiple opportunities.
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polyphemus
Posted on: Jul 28 2014, 12:31 PM


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Condolences to Jack Wood's family.
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polyphemus
Posted on: May 19 2014, 08:40 PM


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I found both of todays announcements extremely helpful in providing comfort on the direction.

The management update was humanely stirring with a bit to read between the lines, as explicit answer to most investor concerns as we have been crying out for. Well done. Interesting views on Vitiligo that should fuel the conspiracy speculation again.
Management Update

Haley Haley got orphans status. Good news for those people. The way I look at it if you call EPP and Haley Haley Orphan than the regulator admits there are problems for people with those indications.

The quote I was mainly interested in was:
QUOTE
Do you expect a positive response to your submission?
The decision is taken by the entire Committee for Human Medicinal Products (CHMP) which represents all members of the European Community. The Clinuvel team is optimistic that it will receive a positive response from the EMA which will enable us to provide access to the drug for European EPP patients.
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polyphemus
Posted on: May 12 2014, 02:01 PM


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The share price has been flat based on lack of forward movement, funds allow that. Also keeps me in the Company, so I say well done to Management, tough but pragmatic decision.

A capital raising now pushes the products current development aims on Non Segment Vitiligo which have already previously shown strong results. 10 month trials and data does not come free, and it is a good investment of money. The NSV is a much larger opportunity than PLE ever was, obtaining funds allows progression and de-risks the investment. As for timing, it had to occur with the ludicrous EMA timeline being undefined.

The Phase 2 in Hailey Hailey is another good sign for potential indications, within the same jurisdictions as EPP. Another Orphan disease as well.

This drug is not just EPP and it is good that the Company progresses other indications.

There is nothing more the Company can do now for the EPP portion but get through the regulator process, and that is now at Patient and Physician discussions. There are a few forums with people discussing their experiences with EPP and Scenesse. From these I would suggest the statements will be strongly for Scenesse approval by the EPP community. There is also a great fear that a negative opinion would remove the use within all European nations depriving those that have received benefit to date and pushing them back into the dark.
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polyphemus
Posted on: Apr 28 2014, 12:33 PM


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Just looked at the trading from last week, it was Instinet that sold down to 1.45. So here is what I think happened. Nomura analyst placed a spec buy on the security which was pretty sound. Nomura Fund Manager buys in but CUV drags their portfolio performance. Fund Manager is released from the Fund position and is liquidated in the 500k transfer and then subsequently sold out.

This is usual behaviour to avoid any emotional attachment to the security by the fund manager.

With the selling pressure alleviated then we should see the stock grind itself back to $1.60.

Sure hope the Company puts out some other news i.e. Sales per region or Singapore vitiligo start, it is incredibly tedious waiting for the EMA to make a decision of benefits vs risk on an orphan indication. I find it amazing that Italy is so progressive in this space, I always had the perception that the Northern Euro states were organised and logical, yet they are so slow to protect their citizens for EPP.
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polyphemus
Posted on: Apr 22 2014, 08:48 PM


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Nomura Instinet has been controlling 50% of trading for the last 2 months. The 500K transfer was a crossing on their books. Why they would be pushing the stock down from $1.70 back to $1.40 is any one guess. Except they are also the only analysts following the company on Fundamentals vs Quantative measures. Their Target price was $3.14, and they too believe the EMA should have delivered a verdict back in q2 13.

Regardless the company has cash to sustain into next year, the only benefit to raiders in delaying to June a ema decision is to miss the Northern Summer, depressing cash flow and requiring further bridging finance for launch and development of Vitiligo.

Clinuvel is not going to partner up on EPP, the only deals possible will be on conjunctive Vitiligo therapy.

Blackm3 the reports you want are on the Clinuvel site - Clinuvels view of EPP alone in their last Corporate Presentation was US$50-100m, however I always liked their pyramid better.
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For Nomuras valuation grab any of the recent reports - they too have been quiet. <http://www.clinuvel.com/en/investors/news-publications/analyst-reports>
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polyphemus
Posted on: Feb 4 2014, 08:18 PM


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I have been watching trading behavior for the last two days with interest. You will see a spike in Volume for the days but it was the way it took place that was interesting. My take on yesterday with an offer to buy 60/- units being withdrawn, followed by successive 5/- grabs at the same price level; and today's price layering, indicates accumulation from a buy side investor not wanting to push the price up (obviously), they grabbed 80/- on Friday, 70/- on Monday and 192/- today. In the last 3 months there has only been 1 week with greater than 200/- in volume.

Why the interest now? Last 3 announcements have been 1. potential of extra review time, 2. cash balances are good but not great and 3. peeved MD pointing out the absurdity for lengthy delays in hearing physician and patient reviews for a drug that has been on the market for 3 years, has shown clear benefit in 3 phase3 trials and has an excellent safety profile over 20 years.

Today's buying was not trying to support a price level, just getting filled.

From my view accumulation buying is with anticipation of a significant price move, obviously up. Significant at 1.30 would be a push back to $1.60-$1.80 range. Seems like a bit of money to throw away, if you don't know something, on a stock with regulatory delays and 1.2 years worth of cash.

Of course if you were to contrarily look at insignificant facts in the Feb news letter and apply to the reality of the situation
Shares on issue: 38,217,038
Average daily volume (past 3 months): 22,944
Average Monthly Cash Burn Oct-Dec '13: A$0.69m/month

What would it mean to a company with 14 months available cash assets to have regulatory approval for a self marketed indication worth an estimated $50m per annum with 38m shares on issue with a block buster 2nd indication going into second set of ph2 trials worth $600 globally @ a double digit royalty rate. Well some people said $9.71.
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polyphemus
Posted on: Jul 19 2013, 07:21 PM


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Tame stuff today - 17,175 sold
Opened at 1.90, algo trading pushed it back down to 1.86. Couple of larger trades near the end of the day started pecking away at the resistance at 1.98. Seemed like some one just wanted to go into the weekend filled which is quite bullish considering where the stocks been trending.

We have a final auction period where 130 traded at $1.89. The 1.97 was after market close.
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polyphemus
Posted on: May 21 2013, 09:16 PM


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Looking at the depth now there is only 35,000 on the offer up to 2.72

Current spread 1.86 bid 2.05 offer. So its not only algo players, looks like the technology has changed the way price forms on securities. You no longer get clear indications of price points of relevance with groups only leaving their orders on for day only. This certainly curtails momentum of the stock.

More of a reason to do proper value analysis of stocks before buying or selling. Dont rush into trades as we can no longer see where the liquidity is. But we will know more when those 3rd phase 3 trial CUV039 results are published. Was due to only take six months, and we are at the 12 month mark since the announcement of the trial. If positive we should find out where the liquidity is very quickly.
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polyphemus
Posted on: May 21 2013, 01:51 PM


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Interesting action on the Australian market today. Little bit of movement before a 20K parcel at 2.02 was snapped up. Have not seen any bot trading for two hours now. Suggestive that it is time for another share price run. Might even get a conclusion to the EMA response quicker than expected.

Looking at the various porphria sites people whom suffer through EPP are extremely keen that this drug be used as a first in class solution. Any EMA review which considers the EPP patients should conclusively see that the multiple phase 3 quality of life indicators are accurate and representative of the benefit to the patient. I still think that odds are for a positive recommendation, based on clinical data and patient feedback.
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polyphemus
Posted on: May 6 2013, 10:15 AM


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yes excellent deal. Well done management. Shows once again the value is grossly under estimated. I would not be surprised to see a 2.20 finish





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polyphemus
Posted on: Feb 27 2013, 08:06 PM


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Headlines Royco, detail was more interesting.
Operational Revenue up from $43K to $531k. Another 10 bagger next year and we are looking cash flow positive. Its possible after a favourable opinion from the EMA -
QUOTE
the majority of the implants were ordered after 1 July 2012 to meet patient demand for the
summer season where UV exposure is at its highest.

29 more implants in Italy - looks like word of mouth is getting out, but more importantly that the drug does what its meant to do.

The Nomura report will make you laugh - they have bravely predicted "We believe the EMA decision is due in the short-term"
Marvelous stuff - any way the results smashed analyst expectations by 10% over most metrics.

Looking at the market today in Australia, we were very thin - so much so that we can expect to be over $2.50 by next week and close to $3 by announcement time next month. Nomura kept their target of $3.39. I am seeing strength building on the buy side.
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polyphemus
Posted on: Feb 6 2013, 09:05 PM


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Think your dates were off - stated March. We should expect a market announcement Friday 22nd February on hopefully a favorable opinion by CHMP from the committee meeting 18-21st February.

After this Scenesse has to confirm how they will package the drug within the month (needs 20 languages or something) then we are off to get EU Community Authorisation

I crunched some dates last year and if you took April 11 as submission date (the date Scenesse appeared officially as under review), 210 days was 7th November. There was a potential 4 month delay for questions. However based on communication from Clinuvel late last year we had got the impression they were well past answering any further questions.

If you take February as submission date then we would have been in the January announcement - add the 14 day validation period and you get 06th Feb (lodgement) + 14 (validation) + 210 (centralized procedure) + 120days (questions) = 15 Jan 2013. Jan meeting was held 14-17 2013.

My estimate for the share price is still 25% under valued, however there has been a few Aussie Biotech companies that have had regulator rejections in the last 6 months, thinking they the perfect case (Pharmaxis and QRX), so the risk or non favourable opinion will be on the minds of most biotech watchers.
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polyphemus
Posted on: Dec 6 2012, 07:59 PM


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I checked which broker was on the sell side with this drivel sell 1 share business. Broker called Instinet, which appears to be owned by Nomura. I doubt that they would be manipulating the stock with any intention, my guess is just using an algo routine that was built for high liquidity stocks. Just Lazy really on their behalf.

QUOTE
Instinet Execution ExpertsTM: Global, event-driven algorithmic trading strategies with advanced liquidity-seeking and anti-gaming techniques operating within a risk-controlled framework.
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polyphemus
Posted on: Dec 5 2012, 08:16 PM


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There are a series of Trading patterns which ASIC may review. The current pattern of layering the top of the spread with 20 1 unit orders is indicative of either a algo engine attempting to get above best average for the day or a poor attempt at manipulation.

Personally the number of sell or buy orders on offer has no impact on my buying habits. I did note a momentum trader came in last week and had put a floor and cap in place. Profits were basically coffee money, we are not talking about a sophisticated trading style here, just some one who has seen the stock rise 15% in a short period and hoped to take a little profit. Was it manipulation? I doubt it. I would say they had intent to buy if the price was hit or sell if their offer was hit.

In regards to Indices, the Market Cap is the key. Liquidity is considered within the decision to include or exclude the stock. We really need to get to top 300 status before we can expect any fund manager action. We have on the registrar a couple of Biotech and Innovation funds.
QUOTE
The S&P/ASX indices only include securities that are considered to be institutionally investable, and market capitalization is a key criterion for stock selection. Stocks are included if they are large enough to meet the minimum ranking requirements for the representative indices within the Australian market.


I have an expectation that the company will get over $100m in market cap around January 2013.
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polyphemus
Posted on: Nov 21 2012, 05:30 PM


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The regulator is addressing these groups that stuff price formation - part of this will be to smash Dark Pools and crossing engines.

"12-290MR ASIC makes key announcements on market structure, dark liquidity and high frequency trading

Wednesday 21 November 2012


ASIC has made new market integrity rules to address risks emerging from developments in market structure, including growth in automated trading and the changing nature of dark liquidity.

ASIC Chairman Greg Medcraft said the rules represent an appropriate policy and regulatory balance. ‘Developments in trading and market structure domestically and abroad are rapidly shifting the landscape of the Australian market, and we see a trend towards more frequent, smaller trades, away from public markets, with implications for the price formation process,’ he said.

‘The rules, the result of industry consultation dating back to 2010, address issues ASIC considers necessary to maintain fair, orderly and transparent equity markets.’"
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polyphemus
Posted on: Nov 19 2012, 12:57 PM


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so we have now taken out the small parcels at 1.85 momentum suggests a 1.90 finish.
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polyphemus
Posted on: Nov 19 2012, 08:35 AM


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looks like the beginning of a strong week. Depth in pre open is filling in nicely. An easy jump back into 1.80, would not be surprised to finish above 1.90 today
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polyphemus
Posted on: Nov 9 2012, 07:28 PM


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Without the Algo orders appearing with that sell level at $1.55 while depth exists means that the sell position has been cleared.

Take sell side pressure off and the stock has no where to go but up. Momentum and volume for the week will start sparking a little interest in a longer term rally. There will be of course a few that buy the rumor and sell the fact shortly.
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polyphemus
Posted on: Nov 8 2012, 05:43 PM


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Price query - they were the days. Basically the company is sitting on a Block buster for Vitiligo with results imminent and has a nice little orphan exclusive due for Authorization, The company use to be valued at $300m mkt cap based on PLE alone. Vitiligo is bigger than the PLE opportunity.

I suspect that we may continue to gap up past 12 month highs beyond $2.40 ($83m mkt cap). But in my mind that's still only 24c. I will be happier when the market cap is $138m or the paltry sum of $4 per share. rolleyes.gif
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polyphemus
Posted on: Nov 7 2012, 09:40 PM


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Yeah have to agree Royco - looks like we are about to gap back over the AUD$2 mark. Strong momentum over the last month.
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polyphemus
Posted on: Oct 27 2012, 01:53 PM


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Lets make it easy for the dates to be put into perspective and what you can infer from Clinuvels comments October 1 2012:

QUOTE
In recent months the EMA completed an initial review of Clinuvel's MAA dossier for SCENESSE® and issued the first formal questions for Clinuvel's teams to assess and answer," Dr Wright said. "Most encouraging for us has been the Agency's agreement with our assessment that the drug has a good safety profile in all the patients for whom data has been submitted

Note the plural months versus month, but we do know how mis-direction works.

Date that the EMA published it was reviewing Scenesse - 11 April 2012
http://www.ema.europa.eu/docs/en_GB/docume...WC500125365.pdf
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If you take 11 April as the start date which it is not,
QUOTE
Since submitting the MAA dossier in February
, it was before then;
120 day mark = 9th Aug 2012
210 day mark = 7th Nov 2012
320 day mark = 25th Feb 2013 --+ 4months in response to questions

You can find the time line structure in this doco
http://www.ema.europa.eu/docs/en_GB/docume...WC500004935.pdf
http://www.ema.europa.eu/docs/en_GB/docume...WC500005056.pdf
http://www.ema.europa.eu/docs/en_GB/docume...WC500108432.pdf
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There is a possible delay of 3 months at 120 and 1 month at 180 day marks

Though I think its more progressed as this indicates a rapporteurs meeting
QUOTE
"We are on track to obtain registration for SCENESSE® for EPP patients," Dr Wolgen added. "The most recent face-to-face meeting with the European Medicines Agency has been both helpful and encouraging. The next few weeks we will learn whether more questions remain to be answered as part of the CHMP's final review or whether Clinuvel has satisfied all regulatory requirements. "


What do you want for Xmas
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polyphemus
Posted on: Oct 25 2012, 09:20 PM


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The Vitiligo opportunity is similar to EPP as far as distribution models go. There is no real benefit to having a larger company doing distribution. The drug will only be accessible to those undergoing NB UVB therapy which only occurs at specialized centers. Clinuvel will know many of the centers through the trials and as such just expand the current method of providing the medication.

Now as the opportunity is rated at >US$600m per annum, so lets say we issue another 30 million shares @1.75 to raise necessary funds to get past launch. It would still be $10 in sales per share in 2016.

Of course this would be outright dumb thing to do for a number of reasons -
1. Today's price is severely under value, and staggered fund raising would be a better approach to capture the release of intrinsic value and reduce risk for those that put in funds
2. If EPP opportunity is realised - it has the potential to fund the Vitiligo program with 2 years worth of sales.
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polyphemus
Posted on: Oct 24 2012, 09:12 PM


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The presentation from March was fairly even handed. The presented group of 15 patients, those with Scenesse required 30% less radiation, they had a 25% improvement from baseline versus 17% for non Scenesse. It was noted that the benefit was not within 100% of patients and there was no conclusions to be made on pigmentation retention - the Oct 16 press release indicates that pigmentation in the lighter skin patients dropped 10%.

Scenesse is not the cure, its aim is to assist in improving result effectiveness and efficiency and reducing patient exposure. That is preliminary data suggests there is benefit over the current treatment of NB UVB alone for the patient and for whomever is paying the bills for the treatments (insurers).

Basically the full results this year will break the tedium of awaiting EPP decision.
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polyphemus
Posted on: Oct 18 2012, 09:28 PM


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Personally I don't think anyone is manipulating the price - I believe an an order exists which has a floor of $1.55 and its a large order being sold using algo trading.

66% of the Company is held by the top 20, so any take over is fraught with danger of failure - its not a great play.

Average Price to Sales is 8.12 in Biotech @ LifeStyle Sector, CUV currently runs at about 60times. EPP represents potential sales, as stated in Clinuvels Investor Presentation, of US$50-$100m, this conservatively places CUV post Europe and US registration the value of US$400m-800m ($10-$20 per share)

Vitiligo is stated as >US$600m opportunity - or valuation of US$4.8b or somewhere around US$140 per share somewhere in 2016

As the estimated Market for Vitiligo NBUVb therapy is estimated at $1.2B-1.4B per annum in the US, I would say the opportunity has been overstated.

Nomura believe the stock should be currently trading at $3.38

For the record - I don't like any computer generated orders within the markets, it pollutes price formation.
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polyphemus
Posted on: Sep 1 2012, 08:32 PM


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yes there are always other options for people, however CUV is first to market and does not include this list of side affects that ISONIAZIDE has
"Adverse reactions include rash, abnormal liver function tests, hepatitis, sideroblastic anemia, high anion gap metabolic acidosis, peripheral neuropathy, mild central nervous system (CNS) effects, drug interactions resulting in increased phenytoin (Dilantin) or disulfiram (Antabuse) levels, intractable seizures (status epilepticus) and drug-induced lupus erythematosus."

I think I'd stick with Scenesse
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polyphemus
Posted on: Aug 22 2012, 07:41 AM


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Its not the same seller as buyer. Simple algo engine blindly selling at what it computes will be the average for the day. Most people are very familiar with these trading recipe's now. It may be the same buyer and seller over the larger spread, forcing the computer algorithm into the buy side. Thats not illegal. In fact when you are buying next and you note an algo trade nipping away at your order move away and it will probably follow. Know that most of these fat geese whom use algos to buy or sell have a lot of units to sell, and in low liquid stocks that works to your favour, dont pay into it.

A trade which results in no change of beneficial ownership is illegal.
Creating a false and or misleading market is illegal, which in my view algo trades are more guilty of than creating a simple buy sell spread.
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polyphemus
Posted on: Aug 6 2012, 07:55 PM


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Cant agree Royco - there is no market manipulation going on. The small shares sales for sub 10 units a trade are simple automated algorithms - basically a sell 20/- order could not be filled with current depth and a $50/- trade is not worth working from a Brokers point of view. Just feed the order into the algo engine and let it sell out throughout the time period allotted.

The reason the share price is so low is that we all did our dough early in the piece at higher limits. Without us true believers buying the stock has no upward pressure. The company is only worth $56m, a far cry from our highs and the sole reason we are not included in any indices in which a fund manager may find potential stocks to purchase from.
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polyphemus
Posted on: Jul 30 2012, 08:23 PM


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Pretty interesting stuff Royco - I am still waiting on what possible therapies CUV9900 would have as well. Anyways more info on that acne trial
http://apps.who.int/trialsearch/trial.aspx...09-018024-15-DE

Main Objective: Primary objective:
- To determine the effect of afamelanotide on the facial inflammatory acne-related lesions in patients with mild to moderate acne vulgaris.
Primary end point(s): The primary efficacy endpoint of this study is:
The percent change in the facial inflammatory acne-related lesions count from baseline to Day 56. This will be done on polled data from Groups A and B.


H0: there will be no percent change in the facial inflammatory acne-related lesions count following afamelanotide treatment.

Secondary Objective: Secondary objectives:
- To determine the effect of afamelanotide on the facial total and non-inflammatory acne-related lesions in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on the overall severity of acne in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on inflammatory biomarkers (cytokines) in patients with mild to
moderate acne vulgaris;
- To determine whether afamelanotide can improve the quality of life of patients with mild to moderate acne vulgaris;
- To compare the effect of two dosage regimens of afamelanotide in patients with mild to moderate acne vulgaris;
- To determine the effect of afamelanotide on skin melanin density in patients with mild to moderate acne vulgaris; and
- To determine the safety and tolerability of afamelanotide in patients with mild to moderate acne vulgaris.
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polyphemus
Posted on: Jul 27 2012, 07:23 AM


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Royco I think its worth remembering the laborious amount of testing and safety data that CUV has been under. In no way did Wolgen and Team skimp on making sure they had safety data of the drug.

The efficacy appear statistically relevant from multiple phase 3, and multiple phase 2 trials.

Further Scenesse appears so useful that Italy registered it for use 18 months ago and Swiss insurers have backed it as a required medical need for EPP.

While EMA wont just be a rubber stamp, there are many reasons for being positive on the chance that the EMA will see that the drug works, is required and is safe.
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polyphemus
Posted on: Jul 13 2012, 07:51 AM


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EMA publish some statistics as well. I think Scennesse has a better than average chance just due to its safety profile and its active use in Italy and now Switzerland.

http://www.ema.europa.eu/docs/en_GB/docume...WC500129799.pdf EMA Stats

Assuming best case scenario and the drug passes scrutiny, Clinuvel is already proving distribution methodology within Europe. It should be rapidly adopted by the EPP community if by nothing else word of mouth.
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polyphemus
Posted on: Jul 10 2012, 09:54 PM


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At this point in the game the methodology management has used appears to be sound. This year the EMA has provided 33 positive opinions vs 1 negative opinion, 4 withdrawals and 1 re-examination. Orphan lodgement this year which we are in, 8 lodged, 5 already approved, we would be one of the three outstanding.

As statistically relevant as the Ph3 trials appear to be, as encouraging as the safety factor and low incidence of minor side affects, the real results are the Italy and now Swiss usage. With actual patients using the drug in normal day to day activity for a condition with no cure is a very good endorsement of the results to the EPP community. Wolgen and team will prepare for the mid meeting with CHMP, I see no reason that it wont go smoothly - specifically that patients using the drug are fine and active, just like the trial results.

The company will still self distribute which in my mind was the way to go. If the drug is approved then the first task is to create new EPP leaflets with a solution to the problem.
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polyphemus
Posted on: Jun 25 2012, 09:16 PM


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Good result for all of us. Placement this financial year - gives breathing room for 1. Vitiligo results, 2. MAA authorisation
No point trying to negotiate without funds - let the results run and do another placement early next year to tie up the following 12 months into 2014. EPP revenues should be able to minimise these further placements to less than 10%. As a company we now have options on how to progress
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polyphemus
Posted on: Jun 11 2012, 09:20 PM


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ha ha you make me laugh. How could Elie Ishag beat Dr P Wolgen M.B.A.

The last corporate presentation after Wolgens interview they were very much on the solo route - that was a key point.

As for Italy there are only 300-800 patients likely to be there. No doubt we have 300 for this Spring/Summer, so we should be looking at $9m Euro in sales right there. Sure that will come out next week in the quarterly communique.
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polyphemus
Posted on: Jun 11 2012, 01:27 PM


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As to the comments on luck required for returning investor cash - a farm out deal, now not a equity distribution keeps the Power within the hands of the company. 33mil shares earning Vitiligo (@10%) and EPP revenues circa $100m-160m p.a. will get the share price over its historic highs of $12-$14.

That said management have never progressed any partnership deals, they did review for EPP Global Distribution rights but in the end have stated in house distribution for Europe will be used. It is always possible to that EPP US could be farmed out to a generic supplier. Fairly safe bet for any group looking for $50m in sales. Strategically it would fit better to have a US distributor and funnel in EPP then Vitiligo's combination therapy which has proven an outstanding success. This model would be at healthier %basis for Clinuvel.

Would not expect any action on this front until August.
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polyphemus
Posted on: Jun 11 2012, 09:24 AM


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Royco - no point getting worked up on finances now. A pure EPP strategy was not taken once we started Vitiligo CUV 101 and 102. While I may have wanted to postpone the Vitiligo work based on the potential expense, the company needs to finish these ph2. Interim results are due and if I was going to do a partner out deal it would be with these results. The partner deal would need to fund the rest of Vitiligo trials, give some small milestone payments for reaching targets. Sales revenue for Clinuvel would be about 10% which means the indication has less benefit to the shareholder than EPP.

The good news is I would try and only farm out one market e.g. Europe, India, or US. Most logical would be US or India.
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polyphemus
Posted on: Mar 21 2012, 08:17 PM


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The presentation is the most buoyant announcement for a while.
EPP market of $100m per year are some pretty big numbers to throw out. Sort of infers that $45 million of that will be by Europe and re-affirms the self distribution model used in Italy will work else where.
Vitligo with a $600m opportunity per year.
Prospective market in India.
PLE, AK, and CUV9900 in the pipeline. PLE was previously rated as $120m and AK at $170m, CUV9900 unrated.

Looks very close to a Block Buster drug again.

33 million shares on issue. With self distribution on EPP in Europe alone we may be looking at a EPS of $1 in the short term.

Note that if we issue 33 million shares at $1.50 to fund Vitiligo all ourselves, we raise the $50mil estimate and still are looking at $10 EPS for EPP and Vitiligo
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polyphemus
Posted on: Mar 21 2012, 07:42 PM


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The minimum parcel rule affects your initial purchase not following purchases. 1 was probably some one trying to get a move. Of course it will have red flagged at ASIC, they will probably issue a please explain to the broker although the trade moved the stock less than 5%, we wont here about it though.
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polyphemus
Posted on: Mar 18 2012, 09:25 AM


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I would like to think its a permanent fix. I do not think as a company we need to worry if Vitiligo is cured, if you take 4.5 million which would seek treatment at $1-2k per scenesse cost, you are looking at up to 9 Billion of unmet need.

Others are a little bit more conservative
QUOTE
GlobalData estimated the global vitiligo therapeutics market to be worth $1.4 billion in 2011. It is expected to grow to $2.7 billion by 2019 at a Compound Annual Growth Rate (CAGR) of 8.8%. This growth can be primarily attributed to the rise in the number of patients undergoing treatment for vitiligo and the launch of Scenesse (afamelanotide) in 2014.s

Global Data

If you read the analyst report from Nomura they are still indicating a 2016 entry for Scennesse in Vitiligo. If we do raise funds this year then it will be delivered within 18 months. not in 48 months.

Still I was more interested in the enhancement of natural coloration of the skin by the drug. Looks like PMLE could be assisted by this as well as potential sunburn.
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polyphemus
Posted on: Mar 15 2012, 08:28 PM


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I had a look at the presentation and the pictures were fairly conclusive in many areas that there is better results using Scenesse vs Not using Scenesse. The caveat was that not 100% of patients displayed the benefit. The person with Vitiligo on the eyelids was basically cured after 4 implants - it will be interesting to see if after therapy there is a reversion back.

Easily enough satisfactory results to pursue into a phase 3. I think Wolgen sums it up nicely
QUOTE
"The scientific advances made with the use of SCENESSE® in vitiligo are clinically remarkable and bode well for the future," Clinuvel's CEO, Dr Philippe Wolgen said
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polyphemus
Posted on: Mar 8 2012, 07:57 PM


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So what your saying is there is no Clinuvel representation at the 70th Annual Meeting of the American Academy of
Dermatology (AAD) – San Diego, USA(March 16-20). I searched the catalog and no direct references to Scenesse or Clinuvel. There was one forum which had good potential to discuss the Inspire program FO91 'Management of the Vitiligo Patient' so my guess is this would be it.

At least I could find them on the roster for Bio Europe March 19-21
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polyphemus
Posted on: Mar 6 2012, 08:05 PM


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Today was the most positive for a while. Very very thin on the sell side and some decent buy side orders. We can expect preliminary vitiligo clinical data presented this month that should be a boost for the stock. That's starting Friday week, March 16-20, you probably can still get tickets.

The surprise for me in the Feb CEO update was the 'looking at all commercial options' for distribution of EPP. I would have thought that Clinuvel had enough physicians on the books to self distribute on request with an easy indication of patient numbers and potential demand. As they have already presented in Europe the early Vitiligo results, the potential if the offer was right, would be to package both indications for the European market. The US markets would be another story.
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polyphemus
Posted on: Feb 29 2012, 08:38 PM


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There can not be a pharma deal before we receive the Vitiligo results of phase 2. At best the company will secure 15% of revenue stream from any deal, they have the potential to get bonus % on sales targets. If a deal is done before then we are looking at sub 10% revenue streams.

Capital raising has to occur and that means issuing 30%-50% more equity to secure funding. They can not issue more than 20% to one entity without triggering a takeover. A rights issue would be precarious as I don't feel that it would be fully subscribed.

From my perspective I would not progress Vitiligo. It is out of our reach at this point ,wait for self distributed EPP sales revenue. Raise enough cash to survive a year and start cutting costs. There is only two effective area to start with which are staff costs and R&D, push quarterly losses to $1m. There are no rabbits which will be pulled out of the hat.
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polyphemus
Posted on: Feb 26 2012, 07:04 PM


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The half year report states $400K was paid in options and performance rights to staff.
Sales were week. It is apparent from other posts and the cash flow that the business will be cyclical; that is all revenue generated in the Spring and Summer, very little in the Autumn and Winter. That said, revenues for corresponding period were up 300% from $40K to $160. I figure that just means 4 new people with EPP versus 1.

Enough cash to last for the short term. As with listing rules the firm needs to be an ongoing concern
QUOTE
The going concern of the consolidated entity is dependent upon it maintaining sufficient funds for its operations and commitments. The Directors continue to monitor the ongoing funding requirements of the consolidated entity. The Directors are confident that sufficient funds can be secured if required by a combination of capital raising, debt financing, licensing partnerships, sale of assets or joint ventures to enable the consolidated entity to continue as a going concern.


Extra expenditure all seemed to be about the MAA filing not Vitiligo.
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polyphemus
Posted on: Feb 19 2012, 12:07 PM


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A buy out would not be best bang for buck. If you look at EPP revenues - estimate is that with generate between $250m and $500m in sales over the next ten years - on a theoretical cost base of less than $50m (purely staff and production costs).

Best bank for buck comes from distribution rights i.e. after ph3 or market registration. Ph 2 success is about 10% of sales
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polyphemus
Posted on: Feb 16 2012, 07:11 PM


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Generally a price drop after submission - what does change downwards though is the risk profile.

Three items I expect to pop up.

Next week a half yearly report. Should include a review of operations and an explanation for the expense increase over last two quarters. Earnings per share will probably dip.
Revenues - looking for a trend in revenue from sales, for the full year in 2011 was $1m. We are hopeful of similar for the half year.
Probably get a Nomura Analyst report - I would say a disappointment on revenue, I think they would like to see $6mil

Expect an approach to the US FDA on filing for registration on EPP.

Expect further Vitiligo results (I expect this is where all the money is being sucked up)
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polyphemus
Posted on: Feb 15 2012, 08:38 PM


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If the application does take 210 days we are looking at 03rd September for confirmation of acceptance. Then who knows how long to get the licence issued.

With Vitiligo - the trial was 6 months, then 6 month follow up. We received initial observations from one of the Centres 21st October. We were given permission in March 11, were advertising for participants in May - so it reasonable to expect full results from 1 site at least in June.

PLE Maybe something will turn up.

I would expect a FDA meeting next month to discuss EPP and whether they could submit the European dossier for phase 3 in the US. After testing 1% of US affected sufferers there is a reasonable chance due to the orphan nature and benefit to the patient.
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polyphemus
Posted on: Feb 13 2012, 06:22 AM


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Thanks Royco, I cant see how we could fund further trials and progress Vitiligo and cuv9000 while taking on more trials.

With the US - I thought the plan was to get EMA approval and then see whether the trials which had been done would suffice for early US registration. Another confirmatory trial perhaps.

The only way I can see any further trials being done if we had larger sales reported in this months half yearly, and that is something i dont expect.
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polyphemus
Posted on: Feb 11 2012, 08:16 PM


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UK is broke. They are raising VAT from 17% to 20% - simple cant afford to fund every drug that's out there.From what I know the UK works with a standard formula when deciding what gets priority, I assume we don't make the cut.

The MAA could be faster or slower - I would expect less than 210 days. They can stop the clock if they have to ask questions, but seeming we have two phase 3 results with a score of other data, 18months activity in Italy, I would not expect that anything was missed in the submission.
http://www.pharmainfo.net
QUOTE
After the complete assessment, the CHMP deliver opinion to EU Commission within 210 days. The EU Commission requests comments from other member states, if a positive opinion from CHMP is received. The other member states can respond in about 28 days. When a licence is recommended, a European Public Assessment Report (EPAR) is produced and marketing authorisation is issued. This authorisation is valid throughout the European Union and is for five years
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polyphemus
Posted on: Feb 1 2012, 09:46 PM


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You may find exhibit 2 in this document informative - indicates at least two weeks for application validation.
How Drugs are Approved in Europe

These cash receipts are from 2009/2010 years sales, not this years sales.

In Jun 2011, you will remember the announcement stating that after 11 months of sales Clinuvel had clocked up over $1million in sales.

Since then we have collected, $171K in Mar 2011, $363K in Sep 2011, and $462 in Dec 2011 for a total of $996K.

The 4C reports are nice but do not reflect sale activity. We have to await half yearly reports for that, some time in February.

Things I noted when I group 9 quarters in a row are: Staff costs have blown out, R&D costs are absurdly high - they should be a million dollars less, receipt growth is growing.

Attached Image

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polyphemus
Posted on: Jan 2 2012, 08:58 AM


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I like the new site. Seems easy to navigate, nice smooth drop down menus and active scroll through topics.

Colours for Scenesse and CUV9900 are garish - guess you have to be a purple person to appreciate. However while it does have all those social media links etc, it has none of those advertisements supplied by search engines - they are just tacky, check out other skin cancer websites.

As an information portal on Skin - it does the job very well - far better than any other skin caner site. Has a nice section aimed at mothers and children. All part of building a family trusted brand.

The part I use - the investor portion has the info I need and remains in blue.
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polyphemus
Posted on: Dec 30 2011, 11:36 AM


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No chance. I would expect like every one else the regulators take the period off for holidays.
Probably January - the EMA has 210 days to reach a decision from lodgement. They could do it earlier, but if they have to ask questions then the clock stops.
It does help that the drug has been in use for 18 months in Italy without incident.
Looks fairly straight forward: In use 18 months, 2 favourable and statistical relevant phase 3 trials, pretty good and noticeable benefit to the patients, very good safety profile, first real option to mitigate EPP - no other approved working scientifically based therapies available.

After that we would only need 600 patients at current prices to fund Vitiligo trials.
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polyphemus
Posted on: Dec 28 2011, 12:14 PM


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Yes, real good to see it taken out, it was being a real downer. Now 20,000 more will put us back in the 2.20 range. lets see how it finishes the year.
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polyphemus
Posted on: Dec 21 2011, 06:54 PM


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$6m for a letter of intent. 10-30% royalty based on sales in US. 12 month escrow before QRX can do their own marketing in the US for max 25% market share.

March agreement sought. All looks good.
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polyphemus
Posted on: Dec 6 2011, 08:02 PM


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The only insider is those that use algo trading to keep the stock down. No point letting the share price rise from 14 cents to 16 cents (pre consolidation).

If you want to be positive think of it like this. Every day we do not get an announcement on fantastic confirmatory phase 3 results is a day closer to getting fantastic confirmatory phase 3 results announcement.

Twelve months ago we ran on expected news from these levels to $2.30. I still savor those purchases over $2 and look forward to doing it again soon.
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polyphemus
Posted on: Nov 24 2011, 09:42 PM


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Because I get bored waiting, I compiled a list of all the good news which the markets ignore. The company is worth at least $150m, that's about $5 per share. My favourite news in the last four years was the patent to protect redheads

If the company insists on continuing Vitiligo trials, it will partner out. These negotiations have been on going since the FDA granted permission for the trials at the start of the year. I would see a sign on if phase 2 was a success and phase 3 required. Minimum ante would be $50m to do phase 3, milestone payment for completion phase 3, milestone payment for accepted marketing, double digit royalty payments.

2008
12/03/2008 EMEA grants Clinuvel two orphan drug designations
28/04/2008 Swissmedic grants Clinuvel Orphan Drug Status for CUV1647
11/06/2008 Clinuvel receives approval to begin Phase II Trials in Solar Urticaria
17/06/2008 World Health Organisation Assigns CUV1647 Generic Name
29/07/2008 FDA grants Clinuvel orphan-drug designation
23/09/2008 Clinuvel commences Phase II trial in Photodynamic Therapy
23/12/2008 Clinuvel lodges IND in US

2009
21/01/2009 Clinuvel announces positive Phase III interim results for EPP
29/01/2009 FDA allows IND status for Clinuvel's afamelanotide
15/07/2009 Clinuvel announces positive results in Phase II Solar Urticaria study
31/08/2009 Confirmatory Phase III EPP trial receives approval.
30/11/2009 The European Medicines Agency grants Clinuvel SME status
17/12/2009 FDA grants Clinuvel an additional orphan drug designation
18/12/2009 Clinuvel announces PLE Phase III preliminary results
21/12/2009 Preliminary results in Clinuvel’s Phase III porphyria trial

2010
30/03/2010 FDA allows US clinical trials of afamelanotide in EPP
16/05/2010 Italian Medicines Agency (AIFA) provides reimbursement for the treatment of EPP with afamelanotide
18/05/2010 Clinuvel unveils SCENESSE® following European brand approval
28/06/2010 Structural changes in preparation for commercial phase
30/06/2010 US patent for alpha-MSH and analogues for use in UV protection
01/07/2010 US patent to assist drug as potential skin cancer preventative in redheads
08/07/2010 Clinuvel selects leading US manufacturing partner for SCENESSE®
13/07/2010 CLINUVEL REPORTS POSITIVE RESULTS IN PHASE III PORPHYRIA (EPP) CLINICAL TRIAL
24/08/2010 Clinuvel to evaluate SCENESSE® as therapy in vitiligo
09/11/2010 FDA provides positive guidance on Clinuvel's EPP program
16/11/2010 TGA grants Orphan Drug Designation for SCENESSE®

2011
09/02/2011 Clinuvel completes first Phase II US study
03/03/2011 FDA allows Clinuvel’s innovative vitiligo trial
12/05/2011 EMA acknowledges Clinuvel filing afamelanotide in Europe in 2011
24/05/2011 Clinuvel granted Australian formulation patent
23/06/2011 Clinuvel records first A$1 million in sales
31/08/2011 Clinuvel completes pre-clinical program for SCENESSE (afamelanotide)
21/10/2011 First positive observations from Clinuvel’s US vitiligo trial
03/11/2011 Clinuvel demonstrates positive treatment effect of afamelanotide in US Phase II study
08/11/2011 Clinuvel granted US topical formulation patent


QUOTE
25/08/2009
"We have ample cash available to complete this program and are fully funded for the filing for marketing authorisation for afamelanotide."


QUOTE
16/04/2009 "We anticipate completing and filing the Phase III study in EPP by Q4 2009.
Regulatory review usually takes 3-9 months depending on the severity of the treated disease, and EPP is considered to be a severe disorder."
"As such, we are currently in a comfortable position to select potential partnerships, if and when these opportunities arise."
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polyphemus
Posted on: Nov 23 2011, 08:19 PM


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Royco the company just diluted shareholders wealth by another 0.75%, we now have 14% of capital sitting as unlisted options. Gratuities that management have granted themselves. I don't think comparing Galapogos to our company as fair, Galapogos went to market with a strategy and kept to the strategy. We are now 87% lower than our highs. It is just the markets way of treating incompetent delivery. Watch how management will pretend that we are filing with the EMA this year. There will be no trial results delivered they will sit with the EMA and say here is our first phase 3 trial results that we could have given you 12 months ago.

EMA will look at the results and pass the product.
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polyphemus
Posted on: Nov 15 2011, 08:56 PM


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Share price is dictated by the lack of results for CUV029. It took 18 months on CUV017 from interim results, to preliminary result to final results. I thought the result on pain in CUV017 were statistically strong. We are also awaiting Phase 3 PLE for a safety profile. I think this trial is more important than a simple extra check box on safety. Any indication of clinical benefit whether statistical based or other, to those affected by PLE will be well received.

While the fine print indicates that filing requires CUV029 results, I would suggest we do not need them at time of filing. The whole purpose of CUV029 is as a confirmatory trial of CUV017. The results can come later, if you review the CUV017 results you will see there is an extremely small chance that the results were based on luck.

Last year we touched $2.40, based on expected results for these EPP trials. We were coming of a similar bottom.

Funding is an issue to be resolved. While Pharma's are looking for new pipelines, a few biotech stocks have gone to market to raise cash versus taking lesser royalty payments. We will see some sort of cash injection 2nd half either from capital raising or Vitiligo phase 2 results and a partnering deal only for Vitiligo treatment royalties 10-15%, EPP, AK, CUV9900 will remain Clinuvels.
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polyphemus
Posted on: Nov 8 2011, 08:15 PM


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Thanks Odi but the link is also on the Clinuvel website.

You may be interested in this one as well:
http://www.clinuvel.com/resources/pdf/anal...03NomuraWeb.pdf

On a positive the Risk valuation for EPP is at 90% with a NPV of $1.91. Still way down on the total $8.20 forecast pre Vitiligo.
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polyphemus
Posted on: Nov 2 2011, 05:18 PM


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Trial results for CUV030 should be ready by now. Our last update was on the 9th of February that the 6 month trial was already compiling results. 70 people out of 77 completed the program. 7 got a placebo and left, that leaves 32 more with a placebo and 38 with the drug. They had to record the number and severity of reaction and the time they spent outside. That's 3 metrics per user, should not take 10 months
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polyphemus
Posted on: Oct 28 2011, 11:25 AM


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The stock price will react to CUV 029 and 030 as long as the results are statistically significant and the measures that quality of life has improved i.e. pain decrease.

I think CUV is significantly undervalued - the analysis from Nomura has incorrect pricing and as such conservative revenues - but we need to remove these trials from their negative overhang and move to the registration point. EPP take up will be quick. If we delay phase 3 Vitiligo until 2013 then revenues should have started from EPP and Europe with registration in the states by mid 2013
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polyphemus
Posted on: Oct 27 2011, 02:32 PM


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Share price will start reacting when the company consistently meets its deadlines. It is nice that the drug works for Vitiligo. We also know it works for EPP, we know it works for severe PLE, we know it works for SU, we know it works for prevention of sunburn, we know it also allows post op patients to go in the sun without the fear of getting skin cancer in the first 10 minutes.

If you go to the Clinuvel website, click on the corporate tab and the Nomura buy recommendation to $8.20 is still proudly displayed (set at 26 Nov 2010 when the share price was at the lofty heights of $1.70). In this report Nomura indicate a $50 per share valuation potential just for Vitiligo.

The same authors projected revenues of $22m in 2012, they changed this later due to how Vitiligo would be progressed, and the delay in results for two pivotal trials, to $2m and stated the company needed a $20m cash injection.

It could be said it serves no purpose for this company to further any Vitiligo opportunity until EPP is on the market. The company can not afford to follow the opportunity without severely affecting the current owners, to delay the Vitiligo by 1 year would be nothing new for current shareholders and probably rationalised at the AGM why the management failed to hit its milestones. No doubt management will also put forward their plan to get Scennesse to market with current funding.

As you can see it is no time to give away free options to management - the company can not afford it. These people were expected to deliver and failed, we could have paid some chimpanzees in banana's and got the same results.
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polyphemus
Posted on: Oct 4 2011, 08:31 PM


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The AGM announcement keeps the fine print that a EMA submission this year is expected. Unexpectedly it also keeps the AGM in Australia.

PW would be increasingly frustrated at the delay in results. However if we focus on the good news:
1. Toxicity results and reproductive studies show a benign impact. High doses have a confirmed reversal of pigmentation within a 28 day period.

2. Audits of manufacturing facilities should have finished. This audit request is a positive sign from the EMA discussion in May.

3. Audits of the Clinical documentation has finished.

4. New Swiss headquarters. Perhaps this time next year we can all fly in for the AGM.

5. Current sell off value is in line with other Australian Biotechs. There does not seem to be too much intention by sellers to go beyond this point, and we are slightly above the broader markets declines.
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polyphemus
Posted on: Sep 25 2011, 01:39 PM


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First on Jack Wood - back in 2008 we voted not to extend him options. So now he has to put his own money up versus being fed gravy from the real owners. I again suggest any plump options packages suggested in remuneration reports should be rejected outright for all on board and directors - no performance no bonus - except for the chief science officer, the CSO is the only one that adds value.

Well I think we can rule out a filing in 2011. Far from the 2007 stated goal of 2009 with sufficient funds to cover multiple indications.

I don't believe management are strong enough to organise a filing - this of course translates to no extra sales in Apr-Jun 2012. Which means we can expect sales of $1.6m AUD. If they were to put that Quantitative Matrix in the annual report the section execution, magn, timely, quality would need to change from a tick to a cross.

I have grave fears for that backwards ticking clock. February 1, 2009 was its deadline. Should now have on it -966 and counting, not sure whether it can take a 1000 days. Its Y2k all over again.

Whats not to like though - we have a completed phase 3 trail and a repeat Client business in Italy, and probably next financial year 2-3 quarters on European sales, to about 400-1000 EPP sufferers.

Personally I will await results before any more money goes in.
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polyphemus
Posted on: Sep 20 2011, 09:08 PM


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Perhaps we have all had the Koolaid.

However it was pleasant to see one Director step up to the plate and have a sip himself.

The strategy is fine, its the execution that is rubbish. The time lines and expectations are not one that investors have placed. They have been self imposed by the Management group over the last four years.

We are about to hit fourth quarter. It was the May 2011 newsletter that reinforced the expectation "anticipated next weeks to months." I read that as 8 weeks tops i.e. July

Lets get this application going - it will take the regulator a while to review and approve and time is money.
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polyphemus
Posted on: Sep 17 2011, 11:00 AM


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To pick up on Royco's point regarding lack of timely milestone achievements.

Perhaps it is time to jettison the Board and Directors. They have not achieved what we have paid them for in an effective or efficient manner. Actually they have not achieved any of the goals that shareholders are after, such as product on market and increase in shareholder wealth. Our wealth has been reduced by a further 30% this year and the remuneration this group we pay does not effectively incentivate them to provide the results, they have no personal skin in the game.

I do not expect anyone would be upset if we raised $20m to fund the next two years. However a dilution of equity by a further 10-20% would not be acceptable.

The lack of published details on the PLE which is two years old is either incompetent or if they know them then it is border line illegal. We only need the safety profile from this trial, however Shareholders whom invested based on PLE require the results.

Inability to provide results from a 6 month trial within 6 months of completion is just incompetent. Especially when we as a company understand the effort required to collate this unique drugs benefits and risks.
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polyphemus
Posted on: Aug 11 2011, 10:39 AM


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We should be expecting the Preliminary final report shortly - revenues need to be shown in this one as a debtor asset. Which of course we fully expect.
We can expect the quarterly communique in two weeks.
We can expect some positive result data shortly.
This business is not based on the health of the finance sector nor should it be rated with the banks.
Some decent news in AUD depreciation against Euro inflates any overseas assets i.e. debtor assets.
From what we can guess revenues past AUD$20m are possible for EPP after marketing approval. That's a lot of revenue for a AUD$50m mkt cap stock.
1yr target should still be around $4.20 even with turbulent markets.
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polyphemus
Posted on: Aug 1 2011, 10:23 AM


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That professor has the runs on the board. I would like a vaccine if possible for myself.

Originally I saw this as a potential threat to the OTR potential, however you would see Scenesse being used as conjunctive therapy to stop burning. EPP and Vitiligo are not viral.

However I see greater potential in people getting vaccinated and getting them straight down to the beach. This will increase the number of sun burn victims each year which will be looking for safe methods of protecting their skin while doing all those summer activities.

There will be a few ways to prevent burning: Expensive and Toxic lotions to be applied topically to all visible skin.
Scenesse pre-protection by creating melanin increase.
CUV9900 for localized protection.
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polyphemus
Posted on: Jul 28 2011, 10:54 PM


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What its saying is that we did not receive the receipts from sales i.e. the cash. We may have made the sales, but we have some debtors. Turn around time on debtor payment is something that the Directors can put in their KPI's.

If we had a balance sheet in front of us we would see we have some Receivables as Assets to the value of $1m. Maybe at the end of August our preliminary Final report will show the full picture.
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polyphemus
Posted on: Jul 28 2011, 09:13 PM


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First me and Clinuvel have a difference of opinion on what a Sale is compared to Cash Flow, I have checked my accounting standards and something is wrong with the statement 'recorded sales'. I am sorry I have no numbers to crunch to derive any sort of valuation on this company. Receipts from Customers of $171k for the year is pathetic. We had expenses of 31c per share, half a cent sales revenue does not cut it.

Second - Staff costs $3.8m, in 2010 we paid $1.8m to the directors. Once again we ask are we getting value for money? They don't seem to do what we pay them to. If you re-read last years annual report that our directors gave us all trial data should have been provided by 2nd quarter this year. That was their signed commitment to us.

Third - it is very, very important that this stock not get to $8.59 by February next year. Anything over $8.60 could see the conversion of 1.2million options. This would add $1.9m to the coffers for a dilution of 3%. And as we know $1.9m just covers the expense for directors so for us owners its not a fair trade considering performance.
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polyphemus
Posted on: Jul 18 2011, 10:21 PM


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Excellent - one step close with the NDA lodgement today. Management delivered nicely ahead of schedule.
Next thing on the list was Strategic Partnership. Keep ticking the boxes.

I under estimated this company will keep accumulating, 126 million shares on issue with forecast peak sales of $680m just for IR.
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polyphemus
Posted on: Jul 14 2011, 09:02 PM


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Finally the depth is not looking anemic. Sellers still refuse to budge, but a few buyers have popped up.

From my perspective a move from 1.70 to $2+ is just the same old trading range being tested. I keep looking at the numbers on EPP for Europe. Current patient population can be expanded by 100 fold. While I would expect the price to drop by 50% and the AUD is 75c to a Euro to remain for the life of the project, we are still looking at a very profitable self distributed indication. I would say I am slightly less excited than those people whom actually suffer EPP, but I am still excited.

I cant wait to see the quarterly report at the end of the month. Some real financial numbers to crunch. Almost like being a kid and waiting for XMas.

I don't know if I am the only one who feels as though the US phase 2 trial data should have been ready by now, completed in early Feb. It is now past 6 months for the results.
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polyphemus
Posted on: Jul 10 2011, 01:20 PM


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Bought a few more on Friday. Depth is very shallow at the moment with sellers holding off on reducing their sale price.

A nice trend is forming in regards to the balance sheet. Costs are stable but revenue from sales is increasing.

This quarter will allow us to see the translation of sales to revenue based on the self distribution model. Should also be able to determine the cost of goods sold.
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polyphemus
Posted on: Jul 3 2011, 12:04 PM


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Pharmaxis is a example of good management getting ahead of themselves.
Safety and efficacy are all that counts for a biotech. I made some money from PXS in its early days, and still think it has a chance. Not as good though as QRX. Safety / efficacy profiles to comparitives looks great from my non medical standpoint. While management seemed less interested in oxygen saturation levels; when you have a family or fried in hospital its good to see that oxygen is in the blood.

Personally I would think the uptake of moxduo will be very good. Given the choice I would be on it in a flash versus morphine. Lets get the FDA process started.
  Forum: By Share Code

polyphemus
Posted on: Jun 29 2011, 09:26 PM


Group: Member
Posts: 532

Picked up some more today on the bounce. Looked like heavy tax selling for the last few weeks.

The moxDuo keeps coming out with safety data and provable effectiveness. I will be relieved once the application process starts.
  Forum: By Share Code

polyphemus
Posted on: Jun 29 2011, 09:18 PM


Group: Member
Posts: 532

Late June sales have been tax sells. With the end of financial year tomorrow the stock should strengthen into July as the sellers no longer have a pressing deadline to deal with. They can wait.
We were at $2.35 at the start of the year - looks like we will finish at $1.70.
28% loss.
Two years ago we were at $2.80.
Lousy performance, lousy delivery of trial data.

On sunnier topics of Capital Raising - CUV does not need the money as long as it can sell Scenesse for EPP in Europe. Wont take much to get cash flow positive. Although we would want that MAA by end of September to have any chance of accruing reasonable revenues next Fin year.

I would prefer CUV to use cash flow to fund debt than issue equity or take lower % royalty payments.
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polyphemus
Posted on: Jun 18 2011, 10:39 AM


Group: Member
Posts: 532

Thanks Oracle - very consistent selling pressure.

The only 'if' I can see is the commercial model for distribution of sales. We are expecting some strategic partnership this year - not clear whether that for distribution, or further trials.

This late in the dev cycle would require a decent royalty split in any partnership.
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polyphemus
Posted on: Jun 15 2011, 10:24 PM


Group: Member
Posts: 532

Another shocker on the market down 8% on reasonable volume. Interesting to here that the trial was designed to assist label claims that moxduo was better than competing drugs. Good to know that it should be first in class for pain relief.

Sounds as if they dont expect to file until July. Would expect the fda to take nine months or so, so if all goes well we should be selling by April next year. Still looking very good.
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polyphemus
Posted on: Jun 14 2011, 02:27 PM


Group: Member
Posts: 532

Strange market reaction to a positive announcement. Completion with statistically significant results. I must be misreading something, I would have thought that this was a boost to regulatory filing.
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polyphemus
Posted on: Jun 1 2011, 09:18 PM


Group: Member
Posts: 532

I had a look at the market today at lunch and was a bit surprised at the lack of depth. No large volume orders hanging around.
Time for another crack at $2.20.

If I was the Nomura analyst I would not put an update out until trial results for EPP are in. Should be very interesting. Last time they kept Vitiligo out of the valuation, which is fair enough because it was not official. Now though with two trials in Europe and US actively progressing there is a strong case for inclusion. And the assumption of 4 injections is now in the air with 6 in Europe.

I think they would feel embarrassed as professionals to put a value out on the company at $18.50, when it can't even stay over $2.
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polyphemus
Posted on: Jun 1 2011, 09:00 PM


Group: Member
Posts: 532

Bit of an over correction I would say. We are expecting news in June of a NDA filing which is a significant step forward.

The natural progression then would be for a strategic partnership. Fundamentally still good.
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polyphemus
Posted on: May 25 2011, 11:28 PM


Group: Member
Posts: 532

Wild ride today - hit a new high only to trade good volume and finish down. Suspect this was based on the weak broader market and profit taking.
Long ride ahead, lets see the NDA filing next month.
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polyphemus
Posted on: May 25 2011, 11:12 PM


Group: Member
Posts: 532

Royco for EPP it is highly possible that if the two European Phase 3 trials were done with acceptable protocol that a US NDA could be done. I would expect the FDA to request further safety trials, which the Vitiligo trials should cover. The other aspect is that we should also expect the Australian TGA to look favourably on the two European phase 3 trials plus current Italian feedback. I rate EPP at about AUD$90m sales per year from the 2012/13 fin year.

What gave my stomach butterflys was on Vitiligo.
QUOTE
The US trial, which commenced recruitment last week, will see patients administered four afamelanotide doses to ‘active’ cohorts over six months. EU centers, awaiting Ethics approval for a further amendment, will administer six afamelanotide doses over six months.

4-6 doses during treatment. I would expect EPP patients to only get 4 doses per year. Considering that Vitiligo affects millions globally, I was thinking we may treat 100,000 a year at $1,000 per injection. Sales of $400m to $600m, nice. At this point we can only hope that scenesse combo is more effective than UVB alone, displaying the same safety profile as now.
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polyphemus
Posted on: May 25 2011, 02:31 PM


Group: Member
Posts: 532

As frustrating as price is. Don't let it blind any holders to the fact we got positive guidance from the EMA. epp may not be a block buster but demand looks good, with a large cut coming to us.

spare a thought on how company prices react to negative feed back. Pharmaxis got cained 70% today on their submission having a negative trend vote by chmp.

revenues have started for us, on a drug and indication that displays clear benefit and high safety.
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polyphemus
Posted on: May 20 2011, 09:53 PM


Group: Member
Posts: 532

Good week for QRX. Volume and price picking up.Air of expectation on the adverse effects trial, with NDA after that. Very good story so far. All without a strategic partnership in place. Very nice.
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polyphemus
Posted on: May 12 2011, 11:02 AM


Group: Member
Posts: 532

Thanks clinuvel that's the announcement we needed to here. Markets don't like uncertainty.
so we now know we are going for full Europe distribution next year.
testing scenesse on children I would think is a bit hard considering the rarity of the disease.
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polyphemus
Posted on: May 11 2011, 09:54 PM


Group: Member
Posts: 532

there was a very large sell order out on close on Tuesday. It did not show up on Wednesday. So I would expect downward pressure until the 200/- order is taken out.
I would be disappointed to here that something went awry with the presentation to the EMA. Hard to follow that one up yet as the EMA reports don't list agendas or outcomes for pre-submission chats - they wont meet again until early June.
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polyphemus
Posted on: May 11 2011, 09:30 PM


Group: Member
Posts: 532

No analysts dont factor PE to determine NPV. This analyst uses Discount Cash flow benefits per share. PE is described at current pricing levels compared to enterprise value. So in 2013 the analyst thinks the enterprise value will still be $60m with 2 mil in earnings for a pe of 30.

NPV is an accounting term - which compares the sum of expected cash inflows with the present value of cash outflows. It discounts the value based on inflation and subjective risk. In our case do we invest $1 today in CUV. What in today's dollars is the expected benefit of this investment.

EPS = earnings available to share holders i.e. profits after tax

To sum up the analysts work on EPP.
8000 patients out of a possible 10000 (est somewhere between 7000~14000 EPP sufferers in Europe and US)
Annual Sales @ 7500Euro = 60mil Euro revenue
Of this the analyst forecast that Clinuvel would get 20% i.e. 12mil Euro
Company tax 30% (drops to 28% in 2014) = 4mil in tax
Minus expenses

Sum up the the cash flow generated each year for the life of the project ... apply the discounting rate and you have the analysts value for EPP which was $1.40 per share. The analyst did state that if clinuvels cut was 40% then NPV was $2.90 for EPP or if price was 10,000 euro and npat 35% NPV was $2.90.

The company has a couple of other revenue generating streams on the go but management has been unable to focus on more than 1 project at a time (sometimes I wonder why we pay them after all these delays). It will be nice when they mention for what purpose CUV9900 may potentially be sold. Vitiligo NPV of $16 even though it is only in a phase 2 trial process. PLE NPV of $11 etc
  Forum: By Share Code

polyphemus
Posted on: May 8 2011, 10:46 PM


Group: Member
Posts: 532

$16 equates to a company worth $500Mn - if you think in pre-consolidation figures $1.60 is not very large
$320 equates to a company worth $9Bn

The stock has two major indications possible PLE and Vitiligo ($320) is based on when/if they get to market. The nice thing with Vitiligo is we dont have to wait for summer to run the trials.

$16 - is based on EPP being accepted. EPP is a severe disease with severe consequence. I expect rapid take up from the EPP community and I expect European Government support for costs

In Feb 2010 Nomura analysts Net Present Value of the company for EPP with a target entry of 2011 was $1.40
Based on 20% of revenues from distributers. [We now know Clinuvel will self distribut i.e. 100% revenue]
Based on Euro7500 per year [We now know Italy placed a Euro32,000 benefit]

So based on MAA success early 2012 I expect $16 easily achievable by June 2012

I do ramp the stock but I am not selling, so its more cheering from the sidelines. The fundamentals have not changed my opinion of a Buy scenario - so I keep buying
  Forum: By Share Code

polyphemus
Posted on: May 6 2011, 07:20 PM


Group: Member
Posts: 532

While there is no news I like to fill in the void by keeping optimistic. As for worth it - first five years significant profits, next 6 years significant losses. I currently prefer my other biotech holdings for the short term. Long term though 2013-2014 this will be a blockbuster.

Nomura professional analyst has a current buy rating to $8.20. My long term target is $320 - short term $16.

To other analytics out this week
on the 4th SADIF put out an update - to paraphrase crap company, crap management, going nowhere. This group uses bulk analytic methods i.e. based on financials reported.
on the 5th BuySell signals put out an update - this group uses Tech (trends) and Fundamental (financials) analysis:
QUOTE
RELATIVE VALUATION INDICATORS [RVI] FUNDAMENTAL ANALYSIS
Bullish Signals:
- The Price to Book of 2.2 lower than average of 6.1 for the Pharmaceuticals, Biotechnology & Life Sciences sector and 2.9 for the Total Australian Market.
- The company is cash rich with Cash to Market Capitalisation at 33.5%.

QUOTE
RELATIVE VALUATION INDICATORS [RVI] TECHNICAL ANALYSIS
Bullish Signals:
- The price rose 0.5% in the last week.
- The Stochastic indicator of 16.2 has broken through the oversold line of 20;.
Bearish Signals:
- The price weakened 2.3% in the last month.
- This has been exacerbated by firm volume of 1.3 times average for the month.
- In the Australian market of 1,337 stocks and 70 units traded today, the stock has a 6-month relative strength of 61 which means it has outperformed 61% of the market.
- The price to 50-day EMAP ratio is 0.97. In the past 200 days this ratio has been under 0.97 32 times suggesting downside. The 50-day EMAP has decreased to $1.962. A decrease is another bearish indicator.
- The Moving Average Convergence Divergence (MACD) indicator of 12-day Exponential Moving Average (EMA) minus the 26-day EMA is negative suggesting a bearish signal. Both the 12-day EMA as well as the 26-day EMA are falling, another bearish signal.
- The price to 200-day MAP ratio is 0.92, a bearish indicator. In the past 200 days this ratio has been under 0.92 111 times suggesting further downside. The stock is trading below both its MAPs and the 50-day MAP of $1.949 is lower than the 200-day MAP of $2.061, another bearish indicator.
  Forum: By Share Code

polyphemus
Posted on: May 5 2011, 11:33 AM


Group: Member
Posts: 532

The market does not quite get it yet on how very close cuv is to registration and the dollar per share impact on income. Depending on take up in Europe and price cuv may be cash positive next fin year. I expect another analyst report out next week. Quite exciting.
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polyphemus
Posted on: May 1 2011, 11:25 AM


Group: Member
Posts: 532

Bought some more last week. Could not resist. Nicely I got the low for the week.
I have some other biotech orders on just to keep the diversification, another company about to submit for approval in the states.
Aussie speculators are happy to invest in mineral explorers even though search to production usually takes 10 years. That's of course if they find any thing in the first place.
The analogy for cuv if it was a miner is that production has started and management are expanding the capacity of ore extraction from the mine. The benefit of our mine is its open pit and pretty safe, next to infrastructure and transport. And we have initial drill assays stating potential large increase in reserves. Our stated mine life is 10-14 years before any other mines open in our region.
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polyphemus
Posted on: Apr 29 2011, 08:25 PM


Group: Member
Posts: 532

We will find out dates Friday next week. But any submission will be based on CUV029. It was expected that trial would finish last year, so I expect management booked the meeting based on knowledge of pending arrival.

Best case would be a submission by August and registration late this year.

We should expect AUD$1.8m in sales from Italy this financial year.
Next Financial year (starting July2011) some where between AUD$3 and AUD$8million from Europe
I would expect the US to authorise the drug in the US early 2012 for EPP. I would expect all trial participants to be interested.
The 2012/13 year we should expect European sales of about AUD$30m, US Sales of about AUD$20m

Depending on Vitiligo phase 2 results we will either dump the indication and start paying divs of about a AUD$1 per share or fund Vitiligo phase 3 ourselves or get some one else to fund Vitiligo ph3 for a chunk of distribution rights (milestone payments or we distribute more equity. 2.5m shares at $20 per share should be easy enough. The phase 2 should conclude this time next year.
  Forum: By Share Code

polyphemus
Posted on: Apr 22 2011, 09:34 AM


Group: Member
Posts: 532

4-7 Months. Appears that there is a maximum of 210 days. I think we should expect 4 months though due to the safety profile, 2 phase 3 trials and recent US phase 2.

Professor Kjell Strandberg MD PhD wrote this document discussing the newer processes of this century. Slide 10 is on review times
Regulatory Trends US and Europe
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polyphemus
Posted on: Apr 21 2011, 07:51 AM


Group: Member
Posts: 532

Pretty good news and start of progress. Availability of the drug for all European EPP is a rather large market.

I would think penetration into the markets will be quick (note to chairman put some facts on take up rates in Italy not vagaries). Probably not at Italian prices. Still we are looking at Earnings once passed of $1AUD per share. Taking the self distribution model. Clinuvel wants to be clear and definitive on that point, it would change analyst revenue forecasts.

This enough to spur me to grab some more.
  Forum: By Share Code

polyphemus
Posted on: Apr 19 2011, 09:20 PM


Group: Member
Posts: 532

First - well done to the new Chairman for getting another communication out. It would have brought some one who was ignorant up to speed with the last 3 years nicely.

Second - next time put some facts in that investors can use.

I felt I was reading the journal of some one whom had Alzheimers. None of the points concluded with anything tangible.

Apparently the board thinks the company can do something more than Scenesse. As we pay the employees 4 million a year that would be nice. They are not going to tell us what that something is. Something to do about a proximity to a field. Sorry forgot to say anything tangible.

The only thing as an Investor I found of interest was the statement on EPP revenues. I have to do my own interpretation of what "we reached our target population in Italy..." means. Not one of the board has ever told us the owners what that target was. Looks good on the employee evaluations, 'met target population'.

Anyway the target has to be stated as 60
60 * 30,000 Euro = 1.8m Euro
Convert to Aussie = AUD$2.4m in revenue from Italy year on year from here on out for several years.
  Forum: By Share Code

polyphemus
Posted on: Apr 9 2011, 11:05 PM


Group: Member
Posts: 532

Have to disagree about the risk factor. The only variance between CUV now and CUV's Sunburn protection run which maxed out at $11 and the CUV's PLE run which maxed out at $14 both on phase 1 and 2 trials is the size of the markets.

EPP has been stated as $25-50m market by analysts not the $5 Billion from Cosmetic tanning or $400m from PLE (now re-stated as $100m)

To put it plainly a new drug needs to
1 - Show more efficacy than existing treatments
2 - show the same benefit of existing treatments with less side effects.

On EPP - there are no treatments -so we only have to look at the side effects. In this case a few hot flushes, nausia in a small % of users while the rest experience statistically significant benefit. If you review CUV017 you would probably skip over this while trying to take in all the statistical p figures
QUOTE
Data Safety Monitoring Board
The study results were deemed to be consistent with the data analyses and use of SCENESSE® (afamelanotide) was recommended as potential therapy in EPP. On the basis of the 12-month safety reports, the use of SCENESSE® (afamelanotide) was determined to be safe for further human use.

From August update
QUOTE
The clinical demand and response to SCENESSE® in EPP has been excellent to date and no serious safety concerns have been identified.


The drug works and it is safe. No risk - Wolgen has to tow the line as far as regulators go. As I said before - No regulator is going to reject a safe drug that works better than current treatment. Well they did not reject it in Italy they embraced it.

QUOTE
The Italian payors assigned a pharmacoeconomic benefit of €32,250 worth of treatment per EPP patient per year.

Its hard to assess what happened in Italy. We were expecting 60 patients. Revenues of $173,848 indicate that only 13 patients have been on for 5 months; or more patients for less time. Any way at worst case @ 22% expected take up in Europe at €10,000 euro acceptable price (see AGM notes from November lowest quote per annum) and we are looking at revenues on EPP of AUD$11.5m or EPS of 26c... and that's conservative. Aussie market run a 12-14 multiple on earnings. Then after that you add Vitiligo and then after that
QUOTE
Finally, after years of internal research, we now have a second molecule (CUV9900) which will complement sCeNesse® for further indications, translating into larger markets.
  Forum: By Share Code

polyphemus
Posted on: Apr 7 2011, 06:57 PM


Group: Member
Posts: 532

I could buy some more that should send it down.

Two 10% up days in a row. Now if it could just do that again tomorrow to give a welcome to the weekend.

If it re-traces I will pick up more. Does not really matter as I am set.

So the question still remains whether we have news coming or just some fund manager buying in.
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polyphemus
Posted on: Apr 6 2011, 08:17 PM


Group: Member
Posts: 532

Todays 9% upward rally is a welcome relief from irrational selling. I was starting to think some one new something I did not.

On both sides I am still seeing algorithmic trading. The art of brokers arranging large sales off market is long gone. Algo trades will always creep towards the other side.

Any way some serious support turned up today layering the sell depth - so we can take it that some one has interest in keeping the security price elevated or that news is indeed expected this month.

I believe the next (CUV029) EPP trial results is the key to de-risking the company. Good statistically relevant results will see granting of access to the market. No regulator is going to knock back a drug that works on a disease with no treatment options. So far scenesse has a safety profile with long term use not having shown any major health issues.

If you review the analyst summation of EPP opportunity it was based on 7500 Euro per year, and only a 20% return from sales to Clinuvel. We now know that 7500 Euro was conservative based on Italian 30,000 Euro.
  Forum: By Share Code

polyphemus
Posted on: Apr 1 2011, 08:40 PM


Group: Member
Posts: 532

On the subject of trials - the following are useful in understanding the EPP scenario. Considering the company will spend $100m and only have 10-12 years exclusivity perhaps 20,000 pounds, 30,000 Euro is not unrealistic as a government subsidized cost.

UK Medicines Information Interesting facts on 2006 trial

University of Birmingham with UK National Institute of Health research Sums the EPP disease up fairly horrifically

World Health Organisation listing of trials

US National Institute of Health recent US trial

CUV029 on the WHO
  Forum: By Share Code

polyphemus
Posted on: Apr 1 2011, 07:56 PM


Group: Member
Posts: 532

Recent price movements appear to be counter to intrinsic value. No point getting suspicious - I just have to keep seeing this as an opportunity to accumulate. smile.gif With scenesse, grrr.gif without scenesse

QUOTE
Due to the lack of effective treatments in EPP and strong demand expressed by patients participating in this study, Clinuvel is in discussion with the US Food and Drug Administration (FDA) to facilitate further drug access for EPP patients.


If I have it right we should get this quarter:
CUV030 Trial results in the US. Two things will stem from this, 1 it willbe added to the European filing. 2 there will be a stronger basis for the compassionate program.
CUV032 Trial results on PLE Europe. Two things from this 1. The drug was safe and that will be added to the EPP dosier. 2 I may get a surprise and we may see statistically significant results and get a PLE filing in 2012
CUV029 Trial Results EPP Europe. First thing to be said here is that the team have gotten better at defining real end points for success. It would be very hard to ask a person with EPP to intentionally expose themselves to the sun with a 50% chance of a placebo with the resultant pain. Second good results will probably see a US filing as well as Europe.

QUOTE
Regulatory strategy 2010-2011
Clinuvel will file its first regulatory submission to the European Medicines Agency (EMA) in Q2 2011 on the basis of the results from three EPP studies: CUV017, CUV029 and CUV030. The Board has determined that the data should be sufficiently robust to obtain marketing authorisation in Europe and possibly also the US. A decision on the timing of filing with the US Food and Drug Administration (FDA) for a New Drug Application (NDA) will be made after an End-of-Phase II meeting with the FDA in October 2010.
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polyphemus
Posted on: Mar 31 2011, 07:25 PM


Group: Member
Posts: 532

I look at the $60m market cap and cant help but compare to the potential market on EPP. $25-$50m

I received first divs from another biotech today. Basically a repayment to share holders of milestone payments. Same value as my initial purchase.

Eventually CUV will have to use a larger group to distribute for Vitiligo $200-$400m - either that or go back to the capital markets to raise cash. I see a nice sign on fee + milestone + royalty. And eventually that will be paid to me the share holder.

The drug works statistically for EPP. EPP users get great benefit. This companies future is very sunny based on that alone.
  Forum: By Share Code

polyphemus
Posted on: Mar 25 2011, 08:35 PM


Group: Member
Posts: 532

I have been badly sunburnt - I would hate to think what EPP people go through if they get careless. If there was a drug that allowed you to enjoy life without fear of the sun I would be desperate for it as well.

Personally I am keen for it purely as a measure of minimising my chance of skin cancer. The rest of the family have all had skin cancer. The only reason I have not is I behave like a shadow jumper in Summer.

The share price though is down for two reasons.
1. Inability of mangement to keep to targets...EPP MAA was scheduled for last year. Clear failure on Management's behalf, do we trust them anymore. Answer No. People will await the cheque versus believing it is the mail.
2. Inability to conclusively get PLE across the line after 3 major phase 3 trials.

Vitiligo is better than PLE as it does not require Summer for a trial to begin, and has a bigger population.
  Forum: By Share Code

polyphemus
Posted on: Mar 25 2011, 06:43 PM


Group: Member
Posts: 532

joe the trial that has not been completed is the second confirmatory trial.

  • European and Australian Phase III trial (CUV015) preliminary results reported December 2009; see the announcement
  • Additional European Phase III trial (CUV032) commenced in Northern Hemisphere in spring of 2010
The point of cuv032 from my view point was simply based on the 015 results being too loose on statistical relevance. 032 seems to be primed at severe sufferers which would give conclusive statistical relevance. Having a re-read the company may surprise and file for SU as well as EPP. SU was rated another $20-100m addressable market

QUOTE
A 2-dose randomised placebo-controlled Phase III trial (CUV032) over the seasons (March-October 2010) will be conducted, and 40-50 Caucasian patients with severe and recurrent PLE are currently being selected in 5 European academic centres.All data from this
study and other trials currently in progress will further support the final registration dossier of afamelanotide in erythropoietic protoporphyria (EPP) and solar urticaria (SU) in Europe and Australia.


Anyway they map out 3000 EPP sufferers in Europe. We need half at 7500 Euro or 400 at 30,000 euro.
  Forum: By Share Code

polyphemus
Posted on: Mar 24 2011, 09:16 PM


Group: Member
Posts: 532

As we move into the next quarter it will be interesting to see whether two Marketing Applications are sent in. 1 for PLE and one for EPP.
The business model had them rated at $100m and $25m.

Previous correspondence had the PLE data arriving first then EPP.

We need 1600 patients at $7500 per annum to cover current company costs. I would not expect that the Inflated $30000 from the italian scheme will stay.

The analysts always predicated their data on a 20% share from revenue to be given by the distributor. i have always thought we will get a larger chunck from the well defined European direct distrubution methodology for EPP. We already have direct physician and client contact for 250 in Europe just from the trials.

Taking on the accounts of people with EPP, there is a clear demand and need for Sceness. Add the safety record and we still are on a no brainer
  Forum: By Share Code

polyphemus
Posted on: Mar 16 2011, 08:24 PM


Group: Member
Posts: 532

Picked more up today on open. The future value of this company is reliant only on getting a successful submission to the European market. I still expect both PLE and EPP success before June, with a registration in Europe filed before September.

I have probably been a bit harsh on PLE. The defining attribute of this drug at the moment is its safety record and lack of serious adverse effects. While statistically PLE was a bit of a dud that required a re-think of how they rate its benefits, a greater number of people have safely used this drug. Eventually I see this drug being used by PLE people based on the current known % benefits. Better to have an option than none.

Nice to see the milestone performance rights lapsed. Management can stop kidding themselves and apply pressure on the groups compiling statistical data. I would appreciate it when they gave time lines it included the analysis point as the completion of the trial.
  Forum: By Share Code

polyphemus
Posted on: Feb 27 2011, 11:55 AM


Group: Member
Posts: 532

Fridays Volume Weighted Average was $2.149

Stock looks over sold at $2.00 -- I expected a bounce off that on Monday. I dont try and pick lows, I try to be ahead of information flow.

Fridays volatility was a little crazy 10% - start at 2.12 move to 2.20 then to 2.00 up to 2.16 then back to 2.00

The increase in volume to 50/- appears to be an exit strategy order - with volatility at absurd levels, I suspect either a forced order or the final leg of an exit strategy which had already sold the bulk at or above $2.15 --- it would have been easy for some one to confuse the NTA drop from 1.08 to 0.73 as being significant.

Fundamentally there were no surprises in the half yearly report. The firm still has 3-4 years of available cash assets, has first revenues booked with a generally successful Phase 3 trial completed with confirmatory trial due next quarter.

It is very difficult for any financial adviser to recommend this security though with the very grey time lines. This is not necessarily CUV Management's fault. The collation of trial data from mutli centre sites has proven difficult and time consuming.

I would like to a know a great deal more about CUV9900.

PLE - I just dont think the drug will prove significantly statistically. I write that indication off and base my future projections on EPP, SU, PDT, Vitiligo and Red Head sun cancer protection.

Vitiligo we should hear about mid February - perhaps in line with the American Academy of Dermatology annual conference. Even at 5% market penetration (assuming the drug helps) at $1000 per annum suggests a sales market of over $2 billion
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