Thanks for publishing your research and some valid points Tony.
Here is a reminder of what's on offer here:
From the RNS dated 14.03.2018:
MED2002, as a topically applied gel with a very rapid speed of onset, has the potential to be a significant product with combined peak sales of more than US$1 billion in a market currently dominated by Viagra® and Cialis®, which are taken orally and do not take effect for at least 30 minutes, and typically one hour or more. ***(ie more than US$1 billion annually)***
MED2002's patent protection runs until August 2028 in the USA and August 2025 in Europe. An additional patent filing announced in 2017 could extend patent protection through to 2038. As an innovator product filed under Article 8(3) of 2001/83/EC, MED2002 will also benefit from 10 years European regulatory data and market exclusivity.
In a nut shell, these two paragraphs highlight the value in MED2002 for interested pharma. The Cello and IPSOS reports contain the rest.
On 9/1/18 in response to an email, JB confirmed that the latest MED2002 patent submission covers 'a range of GTN strengths', and in another response he estimated that 30 months(ish) is the sort of time scale he expected for any new patent application. (New formulation MED2002 patent application submitted 06.03.2017).
Surely (?) the front runners for taking on MED are the big pharmas.
I believe this IS a game for the grown-ups Tony.
It would seem at present that we are still in the preliminaries of separating the interested from the seriously interested, but I believe that the higher the bidding goes:
a The less likely pharma will want a license.
b The more likely pharma will want to buy either MED2002 outright, or FUM and all its patents.
Of course all depends on successful conclusion of phase III studies.
Publically, JB states much interest in MED2002 licences, and the introduction of interest in licensing CSD500, ostensibly to make a MED2002 offer more attractive to Futura.
(Personally I don't believe any big pharma is seriously interested in distributing CSD500 under license. We would know long before now if there was sufficient interest.
I can't possibly imagine how a big pharma would be happy with just a regional deal, with the threat of a rival selling the same product over the border. It would be quite chaotic, would it not?
It would just cramp the style of individual licensee's I believe Tony, - therefore in no licensee's interest IMO.
In summary then:
Begin with regional MED2002 deals.
Currently CSD500 joint deals to make the offering sweeter to FUM.
If the bidding escalates I expect:
Less talk of joint MED2002 / CSD500 deal.
Talk of a Global license to superscede talk of a regional license (only one licensee required instead of > 1, but all eggs in one basket).
- This is what I believe big pharma is really interested in, because by default the winning pharma has beaten off all competing offers.
If bidding escalates further (to avoid the possibility of FUM announcing a winning global licensee):
Offers to purchase either MED2002 or Futura.
It all depends on the tenacity of the bidders, - in other words the size of their need.
FUM could start talking with parties about the PK study results now, not necessarily wait for the end of the second part of the PK study.
Light Blue Touch Paper and........... retire immediately.
"The last RNS revealed that some interested parties wanted to license both CSD500 and MED2002, and that they might want a regional deal. The reality might be that what was discussed was a global deal."
Certainly think it will be a global deal, trump, and the recent CSD link to MED reinforces this belief.
Surely (?) the front runners for taking on MED are the big pharmas. I can't see minnows based in the likes of Croatia or Belgium having a sniff. And I've trawled around trying to find "major" brand names which are shared on a regional basis by different pharmas. Can't find any. CSD appears to be quite unique in this aspect, and even then we don't really know if it's "working properly"!
I can't possibly imagine how a big pharma would be happy with just a regional deal, with the threat of a rival selling the same product over the border. It would be quite chaotic, would it not?
As the following is offered as a discussion document, I wonder how differently others see the competition for a MED2002 license playing out?
Feel free to rip it to bits, but please try to leave something constructive behind.
It has been many years since a large Pharma showed interest in CSD500.
Futura worked well with SSL International to develop and commercialise this condom, but when RB became involved, they sidelined CSD500, then tried to renegotiate the agreement terms, and things unwound swiftly thereafter.
RB went on to take the Chinese condom market by storm, C+D wasted time licensing USA and parts of Europe, but eventually returned the rights. The biggest condom distributors are well aware of CSD500, but have so far not taken any interest they might have any further.
MED2002 License Competition
There is much competition to become the selected licensing partner for MED2002, and that partner will likely insert a contract clause providing the partner with options to buy either MED2002 or FUM. The possibility for a number of regional MED2002 deals was only vaguely discussed in recent RNS's, but all parties are accutely aware that another bonanza, appreciably bigger than that which surrounded Viagra and Cialis is the prize for the owner of the MED2002 patent.
The last RNS revealed that some interested parties wanted to license both CSD500 and MED2002, and that they might want a regional deal. The reality might be that what was discussed was a global deal.
I therefore suggest that some of those parties are using an interest in licensing CSD500, to remain on FUM's short list of most suitable partners for the MED2002 license.
At this point, I assume that FUM have already stated that they want the Phase III trial costs to be met by the licensee.
We do not know how the competition to remain on FUM's short list might develop.
However, competing Pharma might :
1 Offer money to complete Phase III testing of Pain Killers, with a view to purchase or license TIB and TPR products, additional to a MED2002/CSD500 license. The US pain killer market is ripe for ways to deliver non-addictive pain relief. If it is necessary to show interest in all three products however, surely a strait cash offer for the company makes more sense, subsequently selling off any products that are not of interest.
2 Offer to license Dermasys to deliver tried and tested drugs in their own catalogue topically and more efficiently, reducing or possibly eliminating side effects from the systemic application of present drugs. This might allow FUM to benefit from royalty payments, or trigger new patent applications to the longer term benefit of FUM.
In short, competing pharma must at all costs find ways to stay on the short list. JB has indicated little of the behind the scenes manoeuvring currently in play I think.
It seems that more offers are likely, - possibly when the PK studies are released?
However. Since the second part of the PK study deals only with measuring the amount of GTN likely to be passed on to the sexual partner, (not the part that decides the number and strength of doses that will be the subject of phase III trials), then it is FUM's decision who is provided with the PK study data that is available now.
I like the idea of that, - Futura in the driving seat at last Tony!
By the time there are only a few names left on said short list, the only thing left to bid with, (having exhausted the kind of criteria ventured in the previous paragraph), will be cash.
JB mentioned that there were some 'Punchy Numbers' being discussed, but I wonder if he has seen anything yet. It depends on how tenacious the parties become.
He might also be playing everyone along as the deal may already have been done.
By the time the MED2002 Phase III studies are successfully completed, everyone will know what there future prospects in the ED market are likely to be, - and who will have inherited Pfizers ED crown.
Not directly connected to FUM but "might" be when you see what I mean.
This is from IQE
"IQE announced on 15 September 2015 that it had signed an agreement with Silex Systems Limited's subsidiary, Translucent Inc. ("Translucent"), for the exclusive licence of Translucent's unique and innovative 'Rare Earth Oxide' (cREO(TM)) semiconductor technology. The Agreement provided IQE with an exclusive 30-month licence for the commercialisation of the Translucent cREO(TM) technology and an exclusive option (exercisable solely at IQE's discretion) on the subsequent acquisition of the technology. The Company has confirmed that it has exercised its option to acquire the cREO(TM) technology and IP portfolio."
I can def see a few clauses in the licensing agreement that FUM signs with the partner to have the option to acquire FUM should things go well. (The partner would be daft not to have a clause in there)
Mr Barder used these words during the presentation
"Making very good progress... number of major companies where we are making good progress, in some instances it's not only covering MED but CSD as well... bit of a blurring between OTC and prescription...in some regions it is referred to as erectile performance.... we are looking at some quite significant deals"...
I have no doubt that they are looking at some quite significant deals...
If there is one thing I have learnt is that "good surprises" usually arrive when sentiment is at it's lowest and likewise "bad surprises" arrive when sentiment is at it's highest...
The sentiment right now (for some strange reason) seems to be at it's lowest... which is fine by me....
I also note KWS has a poster called Gretal.. he invested in KWS back in 2014/2015 when the share price was £1.50... They had announced some bad news right after they floated... Some people posted "sell"... he posted "buy"... stuck with it..kept on posting "buy"...was the only one posting on that forum.... look who's laughing now? it stands at £17 a share now...
Here's what I think.
AIM investments are always high risk-the nature of the beast!
I have 100,000 of these puppies and they may make my ambition of a villa in the sun a reality!! If they don't and I lose the lot I won't be happy but i'll still be fine without the villa. If you're on here and REALLY need the money you're in the wrong place!
You certainly have an uncanny knack of making an argument out of a discussion, PJ, but entertaining nevertheless!
You've been firing so many bullets I suppose you're bound to hit the target every now and then, but you also occasionally claim to hit the target with a bullet that "apparently" was never fired in the first place! Quite bizarre! So I certainly have joined the ranks of the "doubters" I'm afraid, but don't be offended.
Anyway, we're all still looking forward to those links requested by Nick a few weeks back (re the research or whatever it was you referred to) which have so far not materialised. You never know, these links might restore my lost faith ....... if they actually exist!
Oh, and please take all the above as mild bantering jest and disagreement, and not ferocious anti-chartism bullying!
I cannot remember a meeting so short and with not one question from the floor?
Strange/ or Good?
I am hoping all is good and it is accepted that this will progress as planned by all.
In my opinion this has to be the best ever opportunity to buy in to this at a bargain basement price with short horizons for materialisation.
I think peeps are profit taking when they maybe should be stake building!
I only wish I was only just buying in instead of holding.
Remember this period!
My bet?...This will probably be the best time in history in retrospect to get in.
This can turn at the drop of a hat.
I myself wouldnt like to be out now!
We shall see over the next yr?....On the home straight now for me.
The ranges within your charts are so wide PJ that more or less whatever happens you'll say 'it's expected'... and I'm more and more coming to the conclusion that, over the piece, such methodology is about as useful as eunuch in a harem :-)
That said I'm always interested in you feedback for info. .. so about a week ago you said :
''For the continuing uptrend, a drop to around 43.5p (50% retrace) would be favoured.
Any fall below 38p would be more concerning.''
I'm trying my best to make sense of he TTK situation ....... but failing.
In the 12/9/17 interims it was stated .............. "Kabey will shortly receive its third shipment of stock", but appeared they didn't because nothing was sold in the 2nd half of last year. So maybe they've decided to hang on for the 2 year shelf life from their "usual" German manufacturer? But maybe not, because yesterday it was stated that Kabey's order is "under production". Can't be German, because they haven't got approval yet. So if it's TTK why hasn't this production happened well before now? All very confusing.
I still get the feeling FUM are generally brushing CSD under the carpet to some extent. It appears to be getting in the way ....... understandable if it's taking up a disproportionate amount of time compared to the "prize asset" MED.
I must admit TTT is looking more unlikely the more I think about it. FUM has a mountain of cash which enables them to build more value into MED to complete Phase 3 essentially on their own (with a little added partner help). Looks like Aberdeen's "deferred consideration" is looking favourite, as FUM continue to talk of progressing the pain relief as well as still working on CSD.
"Company fundamentals are not a driver of stock prices and give you no insight into how they will move."
PJ, well I think I agree the above in reference to FUM .....who don't have any fundamentals....other than cash they have in the bank. When the cash is low that 'we' expect a rights issue......and the SP usually takes a hit.
I don't really remember your predictions....only after the event.....something like....'They reached 48p....just as I knew they would'.....maybe you forgot to tell us. Please don't try to claim credit after the event...even I can do that.
IMO Frivolity's theory 'predicted' a spike before the results and a drop afterwards...when people realise it doesn't contain any 'real' news. I guess he didn't give predict precise targets but I don't see that much from you either.
Oh, you're being ironic.
No irony required oil....
And no justification of any theory needed.
Most LTH's (as i'm sure you're aware) have been wrong in their SP expectations here for over a decade now. That's to be expected. Why ?
They base their 'expectations' on news.....and as you see.......time after time ......it proves not the way to go. It won't stop them looking for the next news though !
And as far as the last weeks SP move being based on news goes.......I didn't see you or anyone else making any predictions for the SP on the day the news landed.
What you did is this oilovlam......you watched the SP to see what it did.......and then you came up with a suitable story. All very wise.
Well that must have been very difficult.....forgive me if I don't buy it.
I'll tell you what careful studies have consistently shown time after time.
1) If you knew the contents of an RNS in advance of it's release.....it wouldn't help you with the SP....except in hindsight.
2) Company fundamentals are not a driver of stock prices and give you no insight into how they will move.
A good Proactive interview from JB : reiterated (in the context of CSD launches) that 'some commercial partners' are interested in both products. This, in effect, confirmed that some launches are being put on hold until a MED deal is signed either for MED alone or, as it's beginning to look, CSD as well.
The usual general comments :- "making very good progress with a number of partners" . In "advanced discussions" and talking some "punchy numbers" that will bolster the cash position. I did like the "punchy numbers" reference.
Given the amount of interest then, at the very least, there is the prospect of a MED2000 deal in Q2 that will have good figures attached and probably include CSD as well for the the Church & Dwight territories.
On balance, it's looking like a MED & CSD license with very good figures rather than a takeover but, given the extent of interest, then one or more might make a bold move. I think JB calling them 'commercial partners' rather than potential commercial partners indicates a deal with one of them is pretty much nailed on.
In terms of a bid it will only take one interested party to make a good offer and presumably the board is obliged to announce. A bidder is extremely unlikely to go hostile so they would probably informally assess interest with the significant holders before putting forward something that FUM was obligated to announce.
JB was very quick to say "I can't say anymore" in terms of the MED discussions so maybe TTT will still prevail but I'd say a license that covers both MED & CSD is much more likely.
"Yes ......2 very good RNS's over the past few days.......all on track......even better progress than most imagined in some areas."
Hardly.......oh you're being ironic. Or trying to justify your theory that news doesn't impact the SP.
Couldn't it just be as Frivolity said....people (speculators) were expecting news ...SP rises.....there wasn't any (as predicted by Friv) and so people go elsewhere....SP falls. No, nothing to do with news or lack of it. But all hinged around the results....which is a news event (a 'false' news event perhaps).
Has something happened with the Indian manufacturer of CSD500 (TTK). They should be producing condoms by the bucketload and supplying most of the partners.
Now we have the European manufacturer (German) coming to the fore. They are applying for 24 month shelf life (SL) with them and not TTK. Weren't TTK the primary manufacturer and the Germans a backup?
It is sensible to apply for 24 month SL as soon as you have sufficient data.....but would that automatically apply to the TTK manufactured condoms (assuming they are even manufacturing any).
Should we be told how many condoms TTK are manufacturing per month?....if this was a gold miner I would want to know how much of the yellow stuff was coming out of the ground. Commercially sensitive information....I'm not convinced.
I have yet to see the vision (other than MED2002 of course). Perhaps they are waiting for a big TTT payoff. Not entirely happy....but I never am.
We remain hopeful of approval by the end of H1 2018 from the same EU Notified Body for an extended shelf life product for our European based manufacturer, which will be based on two years', real time data.
JB confirmed last night via email (22:00!) that FUM are seeking a 24 month (not 18 month) extended shelf life for this product from the European manufacturer.
Thank you everyone for your posts and views. I find I generally agree with bits and pieces from everyone.
Interesting points for me were TPR100 another deal could be completed shortly
I was fearful that Stada might return rights of U.K. TPR100 but listening to the presentation and interview has calmed my nerves... some mention of the dossier being over 1,000 pages etc... so happy that it will be submitted in due course
By far the most fascinating piece for me was that some potential partners are interested in both CSD500 (probably for areas previously licensed to C&D) and MED2002...
This explains the silence on CSD500....(for areas previously licensed to C&D)
The bit I found interesting was MED2002 May be positioned as a sexual performance area in addition to a treatment for a medical condition...
Have viewed the latest Proactive Investors video, the presenter seems to be able to put JB at ease and gets more out of him than usual.
They look like a couple of book ends behind the panel, and the JB shirt this time was very average, as was the tie.
Feedback from CSD500 customers included the fact that some users found the condom 'tight'.
JB thought it might be advantageous to look at manufacturing a larger diameter condom?
This could benefit CSD500 sales:
1 Distributors could always play to the strength of the Zanifil technology, by saying that Zanifil was so good that normal size condoms sometimes aren't large enough. (Its would not be a lie).
This for an audience of men who have trouble maintaining an erection when faced with wearing a condom!!
2 I would have thought this product would be popular with female purchasers, and men who felt the need to boast they needed the larger size.
Just listened to the webcast and proactive interview and haven't much to add on top of the comments already made, even though I'm not convinced FUM will strike combined CSD/MED deals on a "regional" basis. But interesting to note that the countries licensed re CSD has been changed from 36 to "more than 27 countries" on FUM's website (the number was 41 before Church & Dwight's exit) so we appear to have lost 9 countries, but I suppose "more than 27" might really mean 36.
Also no mention was made why TTK aren't supplying the condoms. Surely anyone with any nous at the meeting would have asked this, unless the doors remained locked to prevent an audience asking questions?! I would have also asked what the 170 quid sales for the 6 months to 31/12/17 related to (yes .......... ONE SEVEN ZERO pounds turnover for the 2nd half of the year). Looks like TTK are a waste of space, but I got the impression Mr Barder was reluctantly merely acknowledging the existence of CSD through gritted teeth.
All eyes now to mid April and the completion of the PK Study. I do feel we will eventually get our jam tomorrow next time out, rather than the usual day after tomorrow. GLA.
* We are at an advanced stage of discussions in connection with a further regional licensing deal for TPR100 with an additional prospective partner
Now in 'Advanced' stage - but not with STADA.
* Filing expected in Q2 of this year by Thornton & Ross for TPR100.
Announcing further slippage.
* As we have discounted making an online launch by ourselves, we are exploring a number of potential commercial approaches, including jointly licensing MED2002 and CSD500 in some countries.
FUM online launch discounted. Angela was not recruited for this then.
For 'some countries' read 'all countries' for one distributor?
* As highlighted in our previous Interim Report, the regulatory process in Europe has been slowed by the changing structure of EU regulatory bodies. We continue to work closely with regulators to overcome these challenges and to prioritise certain of our submissions and to enable the launch of CSD500 in a number of countries during 2018 and beyond.
Is this a nice way of saying that in the Interims we were wrong to suggest that there are no further regulatory concerns for European partners wishing to launch CSD500? This might explain why there are no European launches as opposed to European partners waiting for a 2 year shelf life product to sell.
* As previously mentioned, we believe that a commercial out-licensing agreement will be announced in the first half of this year.
And only then can Phase III studies be commenced because:
a FUM probably want the licensor to pay for the said study.
b The licensor gets to put into the study, that which it subsequently relies upon to support its marketing claims.
c No sign now of regional MED2002 deals.
It looks like 'Frivolity' had it spot on....there wasn't likely to be any real news in the results and the SP would drop afterwards. Well done.
From an outsider looking in, it doesn't appear they have been very busy.....but I suppose their little duck legs are going like crazy below the surface. Shame we cannot see much of a ripple or much forward progress.
They have binned the idea of direct selling of CSD500 online....pity.
Another 'interesting' webcast awaits.....I think I already know most of the answers (& questions). Pity Tony isn't there to give them a grilling.
Positive no doubt, but still need some meat on the bone as a catalyst to propel the Sp. Hopefully edging very near now though.
Keep the faith! It may not be long now for the long termers.
Over to J.B. now to reward us.
Not surprised that the stock is taking a beating this morning. It looks like there's been inaction with FUM. However, assuming TTT is on the cards (which I'm still very confident about), there isn't much the board could allude to in the RNS.
I think it will recover somewhat after the webcast.
No deal will be done until the full results of the PK study are known. JB would have been in a quandary to explain the lack of movement re CSD500 (without making the market aware that there's a potential TTT on the cards) and hence the "jointly" line was touched on deep in the report.
MED will be a disruptive product and happily, the market is now very much aware of this. I also believe, with the right marketing that CSD500 is a bigger product than many on this board perceive. No large Pharma will want a licensing deal that shares the profits.
I think TTT will occur within a couple of months of the final PK data coming in (assuming it's good!)
Yes, confirmation they are 'exploring' the joint licensing of CSD500 and MED with 'a number of potential commercial approaches' obviously confirms they have several interested parties for both. Given the extent of interest it's quite possible that more than one is exploring a takeover. Commercial approaches' is a nice all-encompassing phrase for FUM to use although it is ostensibly in the context of licensing.
I think they will know their preferred option by now and the finer licensing details but interested parties will want to await the completion of the PK studies expected within the next month.
The higher dose inclusion would be good and, if it is licensed rather than the whole Company sold, then the licensee might fund any extra safety data if necessary. The fact that it seems they can, at the very least, include a dosage that is triple the GTN strength is
going to be helpful to getting either an optimum licensing deal or, quite possible, an optimum offer.
The significant amount of interest in MED and the decent cash position suggests that FUM are in the driving seat here and will have different options to choose from. I hope TTT prevails but a lucrative licensing deal will obviously also propel the share price.
Watch and wait until the PK studies finish - probably in early April but mid-April at the latest.
As Aberdeen has pointed out, all depends on how one reads into it all.
I've quickly read the first few pages and I'm no wiser regarding CSD. But reading between the lines we have ................
"we are exploring a number of potential commercial approaches, including jointly licensing MED2002 and CSD500 in some countries."
.................. which obviously explains why there have been no additional separate CSD deals, plus this .............
"we continue to work closely with regulators to gain approval for an extended shelf life product for our European manufacturer. We remain hopeful of approval by the end of H1 2018 from the same EU Notified Body for an extended shelf life product for our European based manufacturer, which will be based on two years', real time data."
.............. which explains the overall delay for existing deals, with partners no doubt preferring to hang on for the 2 year shelf life.
My overall conclusion following my swift read through is that it still all hinges on the completion of the PK Study next month and the MED deal which goes with it, and CSD and TPR being dragged in its wake. I suppose TTT will focus on the line " jointly licensing MED2002 and CSD500 in some countries" and substituting the word "some" with "all".
Neither thrilled nor disappointed. Will re-read later, listen to the webcam and read other BB views before returning with further thoughts.
I was quite happy reading todays RNS.
They still havent discounted the 0.8 percent.
Note - the 0.8 percent dose is still safe.....
. its just that if it is put forward for FDA approval it would need to follow another route, one requiring additional safety data. If the potential partner is funding the efficacy trial I dont see this to be a problem... if anything, if I were a partner in discussions I would insist the 0.8 percent is included if it meant a greater chance of achieving statistical significance.. the extra cost for achieving statistical significance is a small price to pay. (If funded by the potential partner)..
Like I said I expect there will be clues reading between the lines tomorrow but I suspect it will be very much down to each individuals own interpretation.. some will see it as a glass half full and others half empty.
" completely confident that MED2002 will deliver in Phase III trials"
More so now, trump. Even though today's PK Study update was very much a confirmation of what was expected, nothing in life is certain so obviously welcome news.
Now all eyes on tomorrow. IMO, today's "separate" announcement has in a round about way set up the MED deal to be completed next month alongside official completion of the PK Study. Therefore there is now no "hiding place" for CSD. So either FUM will update by saying ......
A). Progress is ongoing with expected launches in several territories following the appropriate approvals, etc etc blah blah blah ........
..... which will be quite annoying given that we've heard absolutely NOTHING for over 6 months despite being led to believe launches were more or less imminent. One would then have to question FUM's transparency and if there are any underlying issues with manufacture and partner commitment.
Or the update could be on these lines ......................
B). Further launches of CSD are on hold pending the outcome of MED negotiations and an announcement will made in due course.
Love it to be B as this could stir the "TTT hornets nest". If A, then I'm cooling off for a couple of days.
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