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EXCLUSIVE: Alastair Smith, Avacta Group CEO gives an Operational Update


Plethora Solutions Holdings PLC Share Chat (PLE)



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sldmr
Posts: 144
Opinion:No Opinion
Price:0.00
Canister shape change?
Today 21:22
Hi, noticed this from the EMA http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/002693/human_med_001704.jsp&mid=WC0b01ac058001d124
Looks like cannister shape might change, hadn't heard anything about that...
 
The.Italian
Posts: 205
Premium Chat Member
Opinion:No Opinion
Price:0.00
metrics and sales
Today 20:00
alquemie i have largely recovered from the manic hysteria which permeated my previous post and have 2 questions/
1/which other territories apart from the cayman islands have the "Gibson" (sometimes mistakenly referred to as the "Gibbon") as their standard valuation metric?
2/i am not good with numbers.are you really saying that in any realistic scenario there is no possibility of regents revenues from fortacin alone ever achieving a level which could produce a level of profitability such as would sustain the company as a viable proposition?i realise i have posed the question in relatively simple terms and that the complexities of the issues may preclude a simple response but i am trying to get to the nub of what you are saying in terms which i as a non pharma non numerate simple soul can understand.this is genuine question with no criticism of your figures or analysis implied
Alquemie
Posts: 963
Opinion:No Opinion
Price:0.00
RE: Sales
Today 18:59
Whoa,there- rogue line in my spreadsheet.

Should have read Euro 416,000 for Germany (0.33 Gibsons). and for the five core territories, Euro 1.19m (0.94 Gibsons) at 15% peak uptake and a 15% royalty.

Wholesale price of around Euro 24 is certainly much lower than I anticipated (although out of pocket cost will be significantly higher), particularly as in real life, 12 doses is a two month or more supply. Not reimbursed, so scope for future price increases.
The.Italian
Posts: 205
Premium Chat Member
Opinion:No Opinion
Price:0.00
RE: JG vote of no confidence
Today 18:06
professorZ i agree very much with your post.i have expressed concerns over the possibility of the company being taken private a few days ago and do not wish to rehearse them suffice it to say that imo what we have always had and what we continue to have is a small aim type pharma set up by a serial entrepreneur very much in control of it.the hk listing makes little difference in my opinion bearing in mind cayman island incorporation and possible soft hk regulatory regime.this has always been the risk of this type of company and i do not blame anyone else for my involvement as a shareholder.yes the bod seems uncommunicative and we have a history of less than perfect follow through on timescales promised developments etc.i do not think this will change unless a/ we are bought out or fortacin is sold off or b/ sales prove so successful that we actually become a company of substance which would require a different type of management with different mindsets and culture.From todays posts this latter possibility seems remote.
i hope the pessimistic estimates of sales potential prove wrong but fear they may be right and are simply a realistic assessment of the potential market which would i suppose explain the lack of stock market enthusiasm. I cannot explain the share price volume and movements on which poms stakebuilder theory was based but feel the passage of times makes this a far less compelling thesis than i previously thought.Will mellon walk ?probably not at least for the time being but his holdings are now down to about £11m (not sure how accurate that estimate is so happy to be corrected by the more knowledgeable)which is still a lot of money but perhaps not so much to the super rich

apologies for the negative tone of this post but whilst i have tried to remain positive i find i now have to accept that i am no longer living in the land of the magic unicorn and fabled money fountain but in a rather more prosaic harsh and unforgiving landscape inhabited by wraith like creatures living in hope of a share price increase which will enable them to spring free from their years of imprisonment with at least some consolation for the long wilderness years. sorry I've got carried away please ignore me its all been too much!
ProfessorZ
Posts: 2,018
Opinion:No Opinion
Price:0.00
JG vote of no confidence
Today 17:02
More likely to get somewhere by pestering JM. I'd also be cautious before upsetting the apple-cart as the last thing we need is JM selling-up. What I'm worried about is that, as Bignose has stated, this is a closed shop. I'm only in this now because JM stands to lose credibility if he lets us all down - and because I'm too lazy or greedy to sell when things start to pick up.

Ever since we moved to HK, this moved into a static holding for me, when I sell, that'll be it but chances are the company will dissolve before that. I've got 628k (sadly shares not currency) which I'd gladly use to assist in popping a warning shot across the bows of the board, but I fear it is futile and nobody on the board gives a stuff about the share price at the moment whilst there is enough money to pay their wages.

Optimistic head on for a second, we should pick up in the medium term and there is always the chance that a proper company will buy us out.
Alquemie
Posts: 963
Opinion:No Opinion
Price:0.00
RE: Sales
Today 17:01
Oooh, more fun with numbers!

More accurate to use point rather than lifetime prevalence, and being generous on peak uptake and discontinuation rates, Germany returns:

25.3m adult males, 14.5% prevalence of "bothersome" PE, 10% treatment seeking of which 70% end up on some form of pharmacotherapy = 257,000

15% peak uptake, 3 scripts per year, Euro 24 wholesale price, 15% net royalty= Euro 748,000 or approximately 0.5 Gibsons.

Extrapolating to the five core territories (average prevalence 12%, 87.4m adult males, other assumptions as above)= Euro 1.55m or approximately 1 Gibson.

Should roll out continue to the other urology franchise countries (which I still see as likely), I would not expect them to add more than 30% to revenue.
Alquemie
Posts: 963
Opinion:No Opinion
Price:0.00
RE: silence
Today 16:58
Ezzza, while I'm flattered and tempted by the free Octopus pass and new dog n' bone, I'm going to have to pass on this challenging opportunity.

Joking aside, while Mr Gibson makes an easy (and deserved) target, the RP board give the collective impression of a rabbit caught in the headlights. One would have thought that Jim "Related Party Transactions" Mellon, might have a number of decent pharma-savvy advisors, and more appropriate Board members, on speed deal, but, in Woodfordian fashion, either relies on intestinal intuition when it comes to biotech, or on the same bunch of not too bright mates sitting on the boards of his other enterprises.

All the more surprising given the range of issues facing RP: cashflow; the absence of licensable assets (no patent protection or know how) or progress on monetizing the data package through ex-European submissions (and initiation of bridging studies); reliance on a single underpowered study involving an untested PRO instrument for progression in the US; absence of commercial protection/market exclusivity in all territories other than the three year mandatory grant in the US some five or six years in the future; continued manufacturing issues with presumably no post-Brexit fallback in place.

Sounds grim, but still potentially addressable with enough funding, plus skills and expertise that RP cannot currently muster.
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
RE: silence
Today 15:09
Thanks for that. I'll do a bit more digging tmrw to find the email from JG advising there were no other drugs being developed although I am pretty sure it was long after Master Investor, which I do understand JM organises.
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 14:59
Continued

The talk will feature predominantly on activities within Plethora Solutions covering the EU launch by Recordati and progress on US submission and out-licensing. In addition there will be some discussion on potential future activities in Sexual Health and the Diabetic Boot Company.
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 14:58
Bignose
OMG…….I was trying to find the source of my info regarding Dr Mike and his working on V2 when I came across the document from which I posted info from this morning.
However, I was concentrating on finding the source of the info which was a document produced by Dr Mike/ RP.
Having posted the link for you to look at this I realised that this has come from the 2017 Master Investor seminar. This seminar is held annually usually in London and there are various speakers “peddling their wares” in an attempt to get us mere mortals to invest some of our hard earned into them. For instance, Jim Mellon is a regular speaker here.
If you Google Dr Mike Wyllie master investor 2017 show there is actually a picture of him giving the presentation to an audience of potential investors (I can’t download it) but this presentation document is there and the content of this must have formed his presentation. And at the end is all of the info which I posted this morning and therefore must have been part of the “sales pitch”
Bignose…..here is your proof to take to Gibson as taken from the Master Investor Website. This has Dr Mikes picture next to it…..so I would say “guilty m’lud” and please note the last paragraph which ties into the V2 comments in the presentation document
PROFESSOR MICHAEL GRANT WYLLIE, PHD, DSC, CHIEF SCIENTIFIC OFFICER, REGENT PACIFIC GROUP; EXECUTIVE DIRECTOR, PLETHORA SOLUTIONS LTD.
Regent Pacific Group Limited | 14:05 – 14:15
Talk Title: Regent Pacific a major player in Sexual Health today and tomorrow.
Prof Wyllie has particular responsibility for the process of securing approvals of the product, regulatory compliance and assisting the Chief Executive Officer in the commercial development of Fortacin of Plethora Solutions Holdings plc (“Plethora”). Prof Wyllie is a co-founder of Plethora. He has over 30 years of experience in senior management level positions within the pharmaceutical industry, with Wyeth and Pfizer. He has considerable hands-on experience in all aspects of the drug discovery and development process, and has been involved with new project inception, drug discovery and safety testing, early and late stage clinical development, regulatory filing, and the successful commercialisation of products, including Cardura® (doxazosin), Enablex® (darifenacin) and Viagra® (sildenafil). Prof Wyllie sits on the Clinical Trial Design and Future Therapies in BPH Committees of the World Health Organisation International Consultations on Urological Disease and the International Advisory Panel to The University of Strathclyde. He is an assistant editor of the British Journal of Urology in the Sexual Medicine Section. He has over 200 publications and is the named inventor of over 80 patents. He is an independent director on the board of the NASDAQ listed reproductive health company, Repros (RPRX).
The talk will feature predominantly on activities within Plethora Solutions covering the EU launch by Recordati and progress on US submi
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
Sales
Today 14:41
Incidentally, I found something from Recordati where they had stated that even though PE is more prevalent than ED, they were initially expecting only 1:10 of The ED number as seeking treatment.

Based on this: For an example 1mill men, that means 1mill x 0.25 x 0.1 x 0.05 x 0.15 to Regent. = 187.5 (very simplified and assumes 5% Market pen). Ie 0.0188% of the male population goes to RPG. A very long way to go before RPG can pay any anything back to shareholders after paying salaries. (That's according to Recordati with RPG's market pen assumption of 5%.
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 14:29
Bignose.

It doesn't appear to be on the RP website (no surprise in that then). However you can't keep anything away from Google so here is the link that takes you straight to the document. Enjoy.

https://masterinvestor.co.uk/wp-content/uploads/2017/04/MI_2017_Professor_Michael_Grant_Wyllie_-_Regent_Pacific_Group.pdf
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
RE: silence
Today 14:19
Ezzza,
Can you post a link to the document or tell me what the focument is so I can have a squizz. I may already have it, but just in case I have missed it. I can then compare it's upload date to the date of the info I received from the donkeys mouth and even seek clarification.
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 12:34
Hi Alq.
If you would care to stand for election to the board of RP at the next AGM I would take you anytime over Gibson. At least we will get some informative dialogue for shareholders and we will have someone on the board that does appear to have a clue.
However, the downside my friend: Huge reduction in the basic salary but superb profit related pay, HK Bus Pass with 1st class seating and we can throw in a new Samsung Galaxy S9 so that you can easily keep in touch with us mushrooms.
How about it Alq?? Go on…you know it makes sense!!!!
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
RE: silence
Today 12:33
Ezzza,

Thanks for the details provided. All I have to go on is an email from the man himself stating that Plethora were not working on anything else. I questioned this since I found the content in recent announcements very misleading, which they were. I, therefore, suppose all the other employees are helping out with the FDA approval process. I'm sure they will need all of them....or will they.... ;-)
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
RE: silence
Today 10:54
Hi Matt.

Sustainable income was one of my main concerns too which I also made in an earlier post, particularly since currently we are only getting 15% after Recordati have taken all their expenses (what was it. 15% of 23euros/can nett). Granted if they launch 2 more countries this month and 3 more in Dec/Jan, income could double, however. they will not contribute very much to this year (the 2 expected this month with contribute very little with a combined total pop of 30mill) is meaningless if income is low in the first place and still wouldnt pay a 3rd of JG's salary.

Since we have accepted that initial sales will be slow, in contrast to what RP and Recordati expected, it will be interesting to see if the figures have picked up some by the end of the year. Currently, based on the current sales figures, RPG would only get just under 250k Euros. They need 1.5millUSD, just for starters. The last placing which they stated would also be used for further investment, was in my opinion a red herring. The monies were already going to be used elsewhere.

Regarding JM, he will always try to turn a positive spin on it without commiting to anything, hence all the short single word responses...lol . Proof in the pudding is; he seems to have currently lost interest. :-)
Alquemie
Posts: 963
Opinion:No Opinion
Price:0.00
RE: Silence
Today 10:25
@Ezzza, your poster strategy did raise a smile, but as with most aspects of pharma marketing, it's not that simple.

In a nutshell, you can't promote a prescription product to the general public or even name the product unless it's within the context of an indication-specific "infomercial". Professional promotion is geared around clinical data and cannot make direct comparison or reference other products unless in the context of comparator study data. Even the provision of product samples is strictly controlled in quantity and duration, generally requiring a written request from a potential prescriber.

I don't buy into the notion that, after ten years of Priligy marketing, internet resources (healthcare sponsored, not the fake medicine merchants) and with Recordati investing in their own spiffy Fortacin national language websites, that lack of awareness of treatment options is an issue. The reams of published psychobabble on attitudes to PE indicate that simple embarrassment is only one of many factors.

Market development is rate-limited by the very low level of treatment-seeking and by the narrow prescriber base. Taking Germany as an example, Recordati has little primary care presence, but has an established presence in secondary care built around the Urorec franchise. There are close to 6,000 urologists and andrologists in Germany, although not all work in general urology or are accessible to sales reps, giving an initial target for promotion of around 3,000 prescribers. PE consultation is polarised, with some urologists seeing tens of patients per month, others next to none.

Treatment seeking is higher in Germany than other European countries, but is still only around 10% of men "bothered" by their PE: out of an adult male population of 25m plus, only around 250,000 are on any form of prescribed treatment for PE. Discontinuation rates are high for all treatments, so the available treatment population is static
.
Recordati is doing what it can to reach urologists (reps, digital, conference workshop sponsorship, puff pieces in medical journals) but simple arithmetic dictates that it's going to be a long slow haul to gain traction and develop specialist prescriber experience. let alone diffusion of that experience into primary care. Menarini's experience suggests that direct to consumer advertising does little to increase treatment seeking.
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 10:04
continued

§  Many of these can be treated by e.g. prostaglandins (Caverject or Edex)but this involves direct injection into the penis and there is a 30% incidence of pain at the injection site. There is an alternative using a mixture of VIP and phentolamine that is approved in several EU countries but this also involves intra penile injection.
§  There is a high probability that Regent proprietary technology similar to that used in Fortacin will lead to the development of a topical delivery formulation of this agent. The track to market or more realistically out-licensing will be relatively fast as 505(b)2 and there will be premium pricing as therapy for a special needs population. IP protection will be at least 15 years.
Conclusion
A focussed healthcare investment vehicle listed on the main board of the Hong Kong Stock Exchange
§  Unique opportunity to participate in a high growth story with the defensive quality of a healthcare investment in a volatile global equity market
§  Core product Fortacin™ is a European approved treatment for Premature Ejaculation and it has the potential to be the next Viagra in a market that could be worth up to US$3 billion per annum
§  Now available for sale in the UK by way of prescription and expected to launch in Europe in 2017 by Recordati S.p.A tapping into a PE market which affects 1 in 4 men
§  Michael G Wyllie, the scientist behind Viagra and Fortacin™ will continue to provide scientific oversight and input on the development of Fortacin™ and valuate/ identify other exciting ‘late stage’ investments
Ezzza
Posts: 12
Opinion:No Opinion
Price:0.00
RE: silence
Today 10:03
Hi Bignose.
I had a quick search on the internet to see if I could find the source of my info regarding Dr Mike and V2. I seem to remember something about V1 appeared not work on guys with a low Testosterone level and those with severe Diabetes (this last point is to some degree confirmed below). I will have another look when I get back from work. However, I did find the following which was copied from RP, was produced by Dr Mike and was produced just 18mths or so ago.
It reads to me as though they are well down the line with V2 when you take into account the product has been designated the code 505b2, must have been designed and or tested when you take the following into account: . “Regent proprietary delivery technology should result in topically active therapy” and there appears to be a plan of action (don’t hold your breath on that one): “Fast track to market (out licensing as 505b2). Could be out-licensed within 2years”
And
“There is a high probability that Regent proprietary technology similar to that used in Fortacin will lead to the development of a topical delivery formulation of this agent. The track to market or more realistically out-licensing will be relatively fast as 505(b)2 and there will be premium pricing as therapy for a special needs population. IP protection will be at least 15 years”
If JG is now stating there is nothing in the pipeline now then this is clearly at odds with Dr Mike’s overview below. Which then begs the questions “why not and what happened”?
Regent Pacific Group Limited
COMPANY OVERVIEW 25 MARCH 2017 Dr Mike Wyllie
Pipeline Opportunities
Viagra/Cialis (PDEi) Failures
Current Landscape
§  Global sales for Viagra/Cialis and now generics in excess of $3billion pa.
§  Now accepted that almost half of patients receiving Viagra don’t’ respond (particularly diabetics).
§  Arrival of generics has increased number of patients receiving Viagra (and failing to respond).
§  Many non responders will respond to intra penile injection of prostaglandins but pain at injection site.
§  Approved injection in certain EU countries of Invicorp (VIP +phentolamine) with most non responders responding.
§  Sales potential not realised as injection. Regent proprietary delivery technology should result in topically active therapy.
§  Fast track to market (out licensing as 505b2). Could be out-licensed within 2years.
§  Premium pricing as special needs and IP advantage.
Viagra/Cialis (PDEi) Failures
Commercial Opportunity
§  The major remaining commercial opportunity in sexual health is for treatment of Viagra/Cialis failures. Almost 50% of ED patients, particularly diabetics, fail to respond adequately to PDE inhibitors.
§  Many of these can be treated by e.g. prostaglandins (Caverject or Edex)but this involves direct injection into the penis and there is a 30% incidence of pain at the injection site. There is an alternative using a mixture of VIP and phentolamine that is approved in se
MattD78
Posts: 333
Opinion:No Opinion
Price:0.00
RE: silence
Today 09:25
Hi Bignose

A concern I still have with these long periods of silence and delays and updates on deals etc, is the fact that there just doesn’t appear to be enough incoming revenue to support such a high salary for CEO’s performance or the other outgoing expenses of the business without having to generate financial assistance from placings which has been done a few times already without gain to investors, just gain to you know who.

Then there is the investment required into other projects in order to make the company into a proper diversified portfolio of Pharma companies. Where is that coming from as it stands in the timescale, 2025? How are RPG and Recordati working together? No one has an idea or the PR support is a joke with Finsbury, again we have no idea?

I agree that it should in theory be sorted soon but you know the score like the rest of the patient LTH’s.

JM use to tweet others with a ‘Yes’ when asked if still positive about RP but how much have we heard him promote it for the past, what 24 plus months?? Poor all round because the product should be a success as sex sells!

Yes, I am concerned that the available cash being generated in royalties etc is going Ito salaries rather than investment to the company and shareholders.

BoD need to produce these next few months on HK announcement along with other deals to move the share price and market confidence which looks low. Have no idea when it will ever go over HK$1…. I would hate to see another placing in winter to support more of the wage bill expenses, but if deals are delayed I can see that happening.
bignose58
Posts: 1,905
Opinion:No Opinion
Price:0.00
N4p
Today 09:04
Sorry to go off topic, but not much to write about at the moment and the subject is close to home.

I see that N4P are withdrawing from their reformulation of sildenafil (SP has tanked a further 40% today on the announcement). I do remember mentioning this to Dr Mike who said one would get a quicker reaction time by crushing a little blue pill and rubbing it under the hood (only those with duffle coats need apply..lol). Makes one wonder why PLE are not progressing the spray-on idea under Dr Mikes guidance ? (unless Ezzza has found further information to support his statement that they are)
MattD78
Posts: 333
Opinion:No Opinion
Price:0.00
RE: silence
Today 07:35
Input error....I meant 23 Oct 2016
MattD78
Posts: 333
Opinion:No Opinion
Price:0.00
RE: silence
Today 07:31
Interims last month announcing Macau approval was within time stated as per 23 Oct 2017 (take 6-12 months) with Hong Kong 18-24 months which would take it well into mid 2019.
Even though interims saying HK suggested next few months, spinning the timescale and still BoD knowing it will take 18-24 months from Oct 2017.
By saying a ‘few months’ rather than as stated 18-24 months they spin the investors with delayed hope in order to keep funding the grave train of excessive salaries vs what the company can afford to pay them!

Certainly hope it will be this autumn and we shall see what a few months means in the minds of RPG.
Dougie999
Posts: 139
Opinion:No Opinion
Price:0.00
silence
Wed 23:45
would be a big surprise to me to see some positive hk/macau news before the end of year as stated..
Keithbfk
Posts: 11
Opinion:No Opinion
Price:0.00
RE: Silence
Wed 22:27
Isn't Jim bound to quickly respond 'yes' to a being positive? Surely he is unlikely to respond with 'I'm somewhat less positive given that some of my fellow BOD members are about as much use as a chocolate teapot!'




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