Amryt Pharma Share Discussion Threads

[toadhall1] 18/3/2018 15:16

Thanks for the thought provoking analysis all over last few days. I think i will sit tight for now. We will need to let mngt provide more detail to a lot of these questions. Including revised potential for ap101 and also the new in licenced gene therapy for EB (which feels like a replacement but I'm excited by its novel platform approach so will look to learn more). Lojuxta definitely provides a growing floor to the co and generating positive cashflow. Hopefully we'll get a forecast on sales for this year. Should be at least €15MM. I think we get 60% gross profit on that. Would also like to know if mngt received any of the interim analysis that they originally planned to get at this stage for AP101.

[digadee] 18/3/2018 14:10

Hi papsU were in this for EB as you have kept on saying and if you feel how u feel about the outcome (your last post) then best you sell up?

[alphabravo321] 18/3/2018 13:32

I dont think that how they are managing the EB simplex necessarily excludes 101 from being treated for simplex, I am open to correction here

[papillon] 18/3/2018 12:35

Unfortunately, IMO, Thursday's RNS implies that Episalvan will no longer be the EB money spinner we fantasised about. Even if Episalvan is approved (and that's far from certain) as a treatment for EB it's no longer going to be targetting a 1.3bn Euro per annum market. It's not going to be the blockbusting orphan drug treatment we dreamt it would be.

Hopefully Episalvan will be approved as a treatment for EB, but how confident are the company that it will be? Go back to the RNS dated 4/9/2017 where the Chairman almost makes it sound as though approval is a given:

"Amryt's lead development drug is AP101, which is being developed as a new treatment for Epidermolysis Bullosa ("EB"). EB is a rare, distressing and painful genetic skin condition that causes the skin layers and internal body linings to separate and is characterised by extreme skin fragility from birth resulting in EB patients suffering from partial thickness wounds ("PTWs"). AP101 uses a betulin-rich extract as its Active Pharmaceutical Ingredient ("API"). The API is believed to act by promoting the differentiation and migration of keratinocytes (skin cells with wound repair capabilities) as well as transiently increasing the level of pro inflammatory mediators (which also promote healing). AP101 has completed three positive Phase III studies, two in the indication of split thickness skin graft donor sites (219 patients) and one in the indication of Grade 2a burn wounds (61 patients), and one positive Phase IIa study (in the indication of EB). All of these wound types are PTWs and the repair mechanism for each of these wound types is believed to be the same."

Whilst it's possible that the removal of EB Simplex patients from the EASE phase III trials could now makes the approval of Episalvan more of a formality, as the Chairman seemed to imply in the 4/9/2017 RNS, we have to face up to the fact that the success of the EASE phase III trial and approval of Episalvan as a treatment for EB (now expected for Q2 2019) the AMYT share price will NOT be the multi-bagger we dreamt it would be on the news. The lower target potential market for EB means hopes of £1 share price by this time next year are dashed as far as I'm concened. I think the performance of the AMYT share price over the next 12 months will be far more pedestrian. The Lojuxta revenue and remaining cash (20.5m Euro's @ 31/12/2017, but will be lower now) provide some support for the sp, but I'm not bullish in the short term.

[waterloo01] 17/3/2018 13:17

Interesting debate and much thanks for the the input from all, especially Diamond. I lightened up on the news. While the sales and cash look good, and the thing I liked about the AMYT model, it doesn't off-set the delay in AP101, and while it is a sensible action to take, to make approval more likely, the delay is significant enough for me. Naturally it also reduces the potential market size.

Re the 'additional opportunities' I'm less sure what to make of that as this market has been available for some time and as I understood it the reason not to enter some of it was the issue around pricing.

In some of these indications you are dealing with some very inexpensive current standard of care treatments, even if AP101 might be more effective. Equally, I'm not sure I can find any drug that has differential pricing depending on the condition, so there is a danger they 'devalue' it in EB.

Just my thoughts FWIW.

[moneytree1] 17/3/2018 12:06

zzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzzz.......................................

[greendragon777] 17/3/2018 11:56

Thanks a mil for clarifying Diamondstar, that makes complete sense when you put it like that. I thought it might have been a little harsh describing it as a schoolboy error. Hindsight is 20/20 as you say so was not easy to spot before the new data came in from Amicus.

We could be looking back on this in several months time saying that Amicus effectively saved our bacon with regards AP101. Massive Kudos to AMYT's management though for having a good relationship with it's peers in the industry to enable an exchange of info such as this. I would bet my bottom dollar that Amicus wouldn't have shared that data with just any company!

[diamondstar1] 17/3/2018 01:22

No, certainly not a schoolboy error Greendragon. Firstly, it is always easy to criticise with benefit of hindsight. Their Episalvan Ph 2 proof-of-concept (POC) data showed potential efficacy in DEB patients, but they did not have data in EB simplex. The EB simplex group was clearly the most risky, because the FDA had likely mandated a Primary Endpoint of wound healing at 45 days after commencing treatment for both the ESSENCE and EASE trials, which is a very long time. Essentially, in that 45 days, you could postulate that the EB simplex patients wounds would have healed spontaneously, irrespective of whether they received active drug or placebo. At 10 or 15 days, there might have been differences in wound healing between the 2 groups, but this divergence in effect would likely be lost at 45 days, due to spontaneous wound healing in simplex patients.

After completing the Episalvan Ph 2 POC in DEB patients, the next question is how would the drug act in the different EB subtypes. But essentially, my theory is that Amryt didn’t have the luxury and time to run further Ph 2 studies, because they were too busy trying to play catch up with Amicus/Zorblisa.

From POC, they went straight into a pivotal Ph III study, and took a slightly risky approach in including EB simplex patients, which they had no data on. Which was the exactly the same thing essentially that Amicus did anyway for their pivotal Ph III, so you really can’t critisize Amryt too much for their actions, given the circumstances.

As mentioned, it is easy to criticise in hindsight, and the companies developing EB drugs in the future will surely apply lessons learnt from the Zorblisa/Episalvan Clinical Development Programs for their future trials. But Amicus and Amryt are pioneers in this area, and one needs to appreciate this.

What is fortunate is that Amryt managed to avoid a potentially disastrous Titanic situation, by steering the rudder the last minute. For this, they must be congratulated for their quick actions. Hopefully, this will result in a good outcome for the Amryt team, but only time will tell.

[greendragon777] 17/3/2018 00:28

Very good point Paps about their confidence in it's success before they decided to change the trial setup. I don't know the technical details of it all but given what Diamondstar has enlightened us with his expertise so far, would it be disingenuous to describe this as a Schoolboy error by management?

As you said, it's obviously to their credit that they took their medicine (pun absolutely intended!😁) and made the change. I've no doubt that there would be plenty of people that would take the ostrich approach instead and continue on regardless! 🙈

[papillon] 16/3/2018 18:07

Another excellent post, diamondstar. Your analysis makes a lot of sense.

Yes, greendragon, the possibilty of a big share price rise on very good news (say another Lojuxta type licensing deal) before early Q4 is another reason why I also let my heart rule my head. Of course I haven't much skin in the game compared to others on this bb, so if the EASE phase III trial turns out to be futile and we don't get another Lojuxta type deal in the meantime and the share price crashes my losses will be relatively small.

[diamondstar1] 16/3/2018 17:47

Yes, this situation was a bit like the Titanic avoiding a large iceberg! Mind you, the Titanic was built in Ireland (Belfast), not too far away from Joe Wiley, in Dublin.
My read of this Amicus-Amryt collaboration. Amicus has clear interest in the EB market space, having purchased Zorblisa. After the ESSENCE Ph III failed, they did what any sensible biotech company would do - they digged deeper into their data, to understand why they failed. After all, the Zorblisa 6 mg dose showed fantastic efficacy in their Ph 2b. Part of the reason they believe they had failed, was due to a greater effect in the placebo arm. It was also possible this was in part due to inclusion of EBS patients, as the primary endpoint was wound healing at 45 days. Another potential reason is that Zorblisa could have poor efficacy, as the 3 mg dose was not effective in their Ph 2b. After performing very in-depth analysis, Amicus decided to terminate the Zorblisa program. After this news, Amryt saw an opportunity and contacted Amicus, as Zorblisa was no longer a competitor of Episalvan. Joe Wiley could have spoken to John Crowley (Amicus CEO). The gentleman’s agreement could be that if Episalvan succeeds in Ph III, then Amicus has first right to in-licence Episalvan for the North America & South American markets. After all, it looks like Amryt wants to establish itself in EB, and now has a portfolio in EB, with the new gene therapy. My feeling is that Amryt doesn’t want to sell Episalvan to Amicus, but it’s key need is a licensing partner for the American markets, as it can sell the product by itself in EU. Thus, this creates a win-win situation for both companies! And what we are seeing now is data sharing and collaboration between both companies, with a common goal of trying to get Episalvan approved.

[papillon] 16/3/2018 16:22

Excellent post, greendragon. To be truthful I was very undecided yesterday. I never saw the update until midday and after reading it and looking at how the share price reacted (definitely NOT positively!) I was very tempted to sell all of my 25k shares and taken a small loss on the chin. As it was I chickened out and only sold 5k @ 19p and decided, against my better judgement (heart over head!), to hang on to the remaining 20k and await the interim results in Q4 2018 (hopefully the company wont postpone them again).

I might buy back those 5k, even though it might cost me more than 19p per share, if the chart improves before Q4 2018. Or I might buy them back if the share price drops back to the support @ circa 17.50p. We'll see.

[greendragon777] 16/3/2018 16:02

As you say Diamondstar, on reflection this could have been a disaster only for the data supplied by Amicus. To be honest I would do the same if I was in Amicus' position because the data is of absolutely no use to them as Zorblisa failed and that's the end of that particular project so they might as well get some value out of it.

By giving it to AMYT it may give them first refusal on a takeover bid or to buy AP101 outright if it get positive results. It certainly will do Amicus no harm whatsoever sharing the data.

It does beg the question though how this was an oversight, quite a major one. Whilst the data may have given AMYT management pause for thought, it would seem that they should have been excluding the EBS that Diamondstar pointed out in his posts.

Anyway we should be grateful one way or the other as we have dodge a bullet and hopefully significantly increased our chances of a successful trial result.

[papillon] 16/3/2018 14:17

Excellent post, diamondstar. Your analysis makes perfect sense.

IMO Zorblisa being proved to be FUTILE, panicked the AMYT management out of their complacency (they suddenly feared Episalvan would also be proved futile) and led to the completely unexpected placing and ultimately led to them requesting permission to inspect AMICUS's data on Zorblisa.

I'm surprised that AMICUS allowed AMYT to inspect their data on Zorblisa. Perhaps they were just being magnanimous, but I somehow doubt it.

[papillon] 16/3/2018 14:03

moneytree1 16 Mar '18 - 12:58 - 2505 of 2505 (Filtered)

No doubt more garbage directed at me from my stalker, moneytree, diamondstar.

I've always been consistent about AMYT as I am about every AIM listed minnow. IT'S A PURE PUNT ON THE NEWSFLOW. IN AMYT's CASE, AT THIS MOMENT OF TIME, IT'S A PURE GAMBLE ON AP101 BEING SUCCESSFUL. THE LOJUXTA REVENUE WILL LIMIT THE FALL IN THE CASE THAT AP101 PROVES TO BE FUTILE.

Unfortunately moneytree can't understand my position because he doesn't want to. He's a notorious ramper/deramper dependent on whether he's invested, or not. He always has an agenda, an ulterior motive, behind his one-liners.

He doesn't like honesty. Rampers & Pumpers and dumpers never do. He peddles fake news in his one-liners.

Unlike moneytree, I never RAMP stocks I'm invested in on other bb's. I have mentioned on other bb's that AMYT is currently my only share, BUT I have always said I would never tip it. I've always stated quite clearly that I consider AMYT to be a pure punt and no more than that.

Unlike moneytree I'm not a crooked share trader who RAMPS shares he's invested in on other bb's and is a notorious pumper and dumper. Unfortunately posters, like moneytree, take advantage of their anonymity on these bb's to peddle their crooked agenda. These bb's are full of crooks like him.

[diamondstar1] 16/3/2018 13:48

Well, in paps defence, I have to say that what he writes does have logic, and if you follow on from his previous statements, there is often truth in what he says.

Now my time to babble....

Looking back (with benefit of hindsight), it was very risky for Amryt to include EB patients will all forms of EB in their pivotal Ph III trial ie patients with DEB (Dystrophic epidermolysis bullosa), JEB (Junctional epidermolysis bullosa) as well as EBS (Epidermolysis bullosa simplex).

Their Ph II published trial (Schweiger-Briel et al) concludes: The results of the present study were promising and provided reason for further investigations of the effects of Oleogel-S10. Larger studies using Oleogel-S10 for wounds of patients with all different forms of EB are needed to clarify the effectiveness and safety of EB in general.

My understanding: they showed effectiveness of episalvan in their Ph II in a DEB population (10 patients). They had no information on EBS patients prior to their Ph III, who tend to heal much more quickly and spontaneously. The primary endpoint was healing at Day 45: therefore inclusion of EBS patients was very risky. It does not take a genius to realise this. Their look into the Zorblisa Ph III data - simply confirmed this risk, but they have provided a positive spin.

The positive out of all of this - they were able to modify the study design in time - to avoid a huge potential disaster of a failed Ph III study. This could have had big consequences including termination of the episalvan program, or requirement to repeat the study again.

[moneytree1] 16/3/2018 12:58

more verbal diarrhea from paps the dreamer.

[papillon] 16/3/2018 12:52

The AMYT chart is currently bearish. It has been so since the placing news of last September. The AMYT share price is currently moving between support @ circa 17.50p and resistance @ circa 20.30p. I can't see the AMYT share price going anywhere in the next few months in the lead up to early Q4 and the decision on the futility, or otherwise, of the EASE trial (unless you are pottermagic because he believes that decision will not be made for 12 months in Q2 2019). UNLESS we get another, revenue generating, Lojuxta type licensing deal of a suitably approved orphan drug/treatment in the meantime.

PS. The behaviour of the chart and the lack of sustained buying interest recently suggests to me that knowledgeable biopharma investors had guessed that the unblinded interim analysis would be delayed.

[bazworth] 16/3/2018 12:40

Folks, listen to Joe Wiley being interviewed post yesterday's RNS, it really is worth it!!

[papillon] 16/3/2018 12:33

"Perfectly... expect nothing of any value until 12 months time from the AP101 perspective."

Yet more RUBBISH from you, pottermagic!

YESTERDAY'S RNS DISTINCTLY STATES THAT THE UNBLINDED INTERIM ANALSIS, DUE EARLY Q4 2018, IS WHEN THE DECISION TO CONTINUE WITH THE EASE TRIAL, OR WHETHER IT'S FUTILE TO CONTINUE WILL BE MADE. In other words, Isaac Newton, the fact that the EASE trial could be discontinued as it's deemed completely futile to continue is NOT of value in your mind?

So you, Albert Einstein, reckon that the Q4 2018 decision to continue, or not, with the EASE trial is "NOTHING OF VALUE UNTIL 12 MONTHS TIME"? I pity you, pottermagic.

pottermagic? FILTERED. I can't be bothered to read your drivel any longer.