The latest Investing Matters Podcast episode featuring Jeremy Skillington, CEO of Poolbeg Pharma has just been released. Listen here.
ok got it...my mistake
Hi....the move makes absolute sense, simplifying things and saving costs. I just want to make sure that the value of my investment is not reduced during the transfer. Is the current value of my holding converted to $ and the respective amount of ADS's issued? or am I simply issued 1 ADS for every 5 Ordinary shares? If the latter 1 Ordinary share = $2.22/5 which equals 0.44cents per ADS share and given the current share price of 0.11cents ...i lose 3/4 of my investment which i am sure isnt the case. Can anyone clarify?
would they have a buyer lined up for the voucher or will they hold an auction?
A couple of questions...
Does Amryt have the capability to manufacture and distribute Filsuvez globally?
Whatever happened to the gene therapy for EB and where is that in development?
The second smaller CVR is dependent on a positive opinion from the EMA application.....they submitted their application to the US for MAA but did they do the EU at the same time?
I suspect that Joe is itching to spend that 40M he raised a few months ago....could be the reason for the rise if that is imminent. With the MAA submission for Filsuvez and hopefully the approval coming along shortly and the subsequent issuing of the accelerated review voucher absolutely no reason to sell this year at least. These are big milestones and I would expect significant uplifts in the sp off the back of those.....plus it is a profitable small-medium biotech, a rarity!
Joe must be itching to spend that 40M he raised a few months ago....wonder if that is on the horizon hence the rise. With the submission of the market authorisation application for Filsuvez to the US and EU imminent, subsequent approval and then issuing of the accelerated review voucher all in the next 6-9 months....it would be madness to sell before the end of the year in my opinion.
from what I recall the Krystal product requires sophisticated temperature controlled storage so needs to be used in the clinical setting....the Amryt product is room temperature and can be used off-the-shelf at home. Big difference in practicality and ultimately sales I assume.
I presume harry wouldn't be buying if the EASE study data looked bad.....
Interesting to see this steady price rise is not RNS-based which have been fairly transient for Amryt in the past. This stock was never going to be a quick win for investors....maybe now individuals/investors are taking the long-term view of the company and see positive developments ahead.
I am also a LT holder...since the IPO and have never seen my shares be worth more than I paid for them in all those years. Still needs a further 4-5p to break-even. That said, I am optimistic for the future of Amryt. The EASE study will meet its primary end point as they would have stopped it after the interim review if it wasn't heading in a positive direction due to the costs involved in running a global rare disease study being huge. This brings the paediatric voucher in to play in Q4 when they register the product in the US. The sale price of that should be around 100M plus they also have 60M in the bank. I am sure that isnt gathering dust under Joe's mattress and I expect further acquisitions soon to go with their existing commercial and profitable drug portfolio. Rory and Joe have built something good here for the long term...I have worked for several small biotechs and know how difficult it is to do that and most fail even before reaching the market...so hats off to them. I think this company us grossly under valued and has a great long term future.
Just a note on AP103....they bought it out of an academic lab so there wont have been any formal safety testing done I expect. A normal therapeutic takes about 2 years in pre-clinical tox testing but a novel gene therapy will take longer however that is probably not the rate-limiting step, it will be the development of a GMP manufacturing process from scratch in order to make something suitable to put in humans....probably 3 years of work..if all goes well.
What ever happened to AP102?....no longer in the pipeline I see. That should have been heading towards the clinic for acromegaly some time ago unless I missed something.
yes we should be getting an RNS any day now on that I expect. The fact that they ever so slightly increased the patient numbers beyond what the review committee proposed at the interim analysis suggests to me that they know it works but just needed a few extra to gain statistical significance. If you look at the background publications on the bioactive in cream used in the study....the effect isnt huge but it is there at least in vitro..hence the large number of patients needed to prove it works in the clinic. Given there is nothing out there like this, ie with the ability to accelerate the wound healing process (the rest are just hydrating/barrier creams and gels) it should be a positive outcome for the majority of patients who use it....and each patient will likely use significant quantities of it. There are other more serious forms of EB and skin diseases such as TENs who will also likely benefit from this I assume.
Data should be positive on the EB trial as the review board would have stopped it at the interim review if it wasn't. Q2 for the primary endpoint readout. then I assume then 3-6 months for the registration process. Paediatric voucher available for sale at the end of 2020 perhaps?
we must be about due a notice on the end of recruitment in the EASE trial...I hope.
...just to add to the mix, we should be expecting recruitment in the EASE Phase III to be concluded in the coming weeks. Given the Interim review was largely positive, I anticipate a positive top line readout with the primary endpoint being met in Q4.
As Aegerion was listed on the Nasdaq some time ago....does this open the door to the combined Amryt-Aegerion entity finally making it into the big time and trading alongside the big boys? It was an objective of Joe Wiley's way back in the early days of the company....with the intent of accessing greater liquidity for further expansion so I believe.
Bronx...what you are referring to is the timeline for the 2 year follow-up. Something that will be submitted as a post market commitment. The primary endpoint is what matters and I think that is 45 days after last patient in...which Amryt tells us will be this Summer with the top line results being published by the end of the year. Then they will move on to the US Market application which, with an accelerated review, should be done in 6-9 months. All being well, MAA for EB will around Q3/4 next year....then the voucher becomes available and last time I looked the value of that at auction will be around $100M. I assume they will never market Episalvan for the high volume low margin burns market but rather focus on the low volume high margin rare disease market of EB. Once MAA for EB is sorted, I also expect them to broaden the indication list for the product in other high margin rare and serious skin diseases. Because the EB study is so big, they will have a huge safety database which will make expansion into new indications relatively easy.
it is, several technical aspects make it better than the Krystal product.....but it is a year to 18 months behind
The previous Phase III studies in burns (two studies) and split thickness skin graft donor sites were done by Birken AG just prior to the acquisition by Amryt...Birken also successfully applied for Market Authorisation for what was known as Oleogel-S10 at the time and now known as AP101. In both indications there was an acceleration in the closure of the wounds....not by a huge amount but it was statistically significant. Hopefully this can be translated into efficacy in EB as well as there really is nothing out there to improve this condition. Typically they slap vaseline on the wounds which does little except maintain hydration of the skin. The Amryt product seems to stimulate wound closure in the studies above which would be a step in the right direction....plus the bioactive in the gel, betulin, is a known anti-inflammatory agent and published data shows it can improve skin "condition"......overall i am pretty optimistic about seeing positive data from the EASE study.