Amryt Pharma Share Discussion Threads

[papillon] 15/3/2018 13:00

On further reflection, greendragon, my take on the EASE trial delay is as follows. I believe that the decision by AMICUS to ditch Zorblisa really worried the AMYT management. It panicked them! They wondered if Episalvan would suffer a similar fate to Zorblisa and if it did they would have to raise further cash soon after the EASE interim results were issued and the share price had plummeted at a drastically lower placing price causing huge dilution. Hence the decision, which surprised the market, to rapidly raise 13.3m Euro's (after expenses) not long after the Zorblisa news.

To improve the chances of success for Episalvan the AMYT management then went cap in hand to AMICUS for permission to access the Zorblisa trial data. Now I can't believe that a hugely successful American biopharma, like AMICUS, would give something away for nothing!! I'm sure they would have wanted something in return and I believe that to be the opportunity to purchase Episalvan if the EASE trial is deemed a success. Companies like AMICUS don't give something away to a minnow like AMYT without getting their pound of flesh in return.

[greendragon777] 15/3/2018 12:53

I agree Paps, it's more like a delay of 3 or 4 months. I would much rather that small delay with an increased chance of success than rush it and end up with nothing!

Yes this means the big news is delayed that will ultimately effect the share price but overall I am even more optimistic about AMYT. That said I wouldn't be surprised if we see the share price slip again over the next 5 or 6 months like it did before as it might go very quiest again.

I'm very happy about today to be honest. Was it worth getting up for at 7am?....now that's the big question! hahaha

[greendragon777] 15/3/2018 11:25

Thanks Diamonstar. At least it won't suck up a pile of additional cash from their reserves so hopefully they will get a positive result before any additional capital is needed. Lojuxta might even take us all the way in term of cash requirements.

@sidam My understanding is that the sale price for the other uses for AP101 would be lower than that for a treatement of EB hence why they have been holding back.

@timbo That's a very good point on a potential smaller market as a result. I wonder though would it be subscribed anyway by doctors if/when it's approved but I have no idea how this works, just purely speculating. I would hazard a guess though that the numbers are manageable if the increase in patient numbers is about 30 (circa 20%). Maybe the actual % of the overall patients is smaller in practice but again I'm just speculating. Perhaps Diamonstar would be able to throw some light on this.....he carries a permanent torch with him around here! haha

[timbo003] 15/3/2018 10:53

I'm reasonably pleased with progress and agree that modifying the trial design to exclude EB simplex patients seems like a prudent think to do, however I assume there will be another potential downside (in addition to the delay) i.e. the target market will be smaller.

Does anyone know what % of total EB patients are EB simplex?

[sidam] 15/3/2018 10:03

Am I being stupid, but the announcement that other uses for AP101 have a potential market larger than EB seems to me to be of huge significance. However, nobody seems to have commented on that. Could it double the potential value of the company?

It is the main body of the text.

[toadhall1] 15/3/2018 09:29

Interesting developments with potential. Smart management. Sure EASE is a minor short term surprise but that's Biotech! Often subject to unforeseen delays. This decision hopefully increases chance of success. The beauty of this small biotech is that it is well capitalised, and has an increasing revenue stream from Lojuxta that will continue to generate cash to fund these extra clinical trials. That sets this apart from other biotechs with similar MCap. If you read to the end of the RNS it suggests the new licence gives a novel gene delivery platform that could give a competitive adv. I need to do some research on this.

[diamondstar1] 15/3/2018 09:06

I think the 1 million euro should cover the direct costs ie additional costs related to running the trial. Essentially, by excluding EB simplex patient, they will have to recruit more non-simplex patients. For example, instead of 164 patients, they may end up recruiting 200 EB patients now, but exclude the EB simplex patients from the analysis set.

This however is the direct costs. The indirect cost could be staff costs or even costs related to delayed approval. A drug that may have an annual revenue of £200 million, for example, a 4 month delay implies a potential ~£70 million loss in future revenues.

Importantly, one needs to maximise chance of EASE being positive rather than getting there earlier - better to have a drug approved that can deliver £200 million revenue, than no drug approved (albeit study completed earlier).

[greendragon777] 15/3/2018 08:26

Nice one Diamondstar. Great to get your expertise on this development.

Totally agree with you that it's a big plus having this data and making the adjustment is absolutely the right call, even if it means a delay by a few months.

Do you think the added cost of €1m they mentioned will cover everything with regards the delay? Seems like a small price to pay for a potential significant increased chance of success!

Also would you have any idea what sort of funding would be required for the Gene Therapy agreement with Trinity? I didn't see any costs mentioned but I'll need to read again. They did mention it would be funded from existing cash but hopefully it won't be a major drain on cash for the foreseeable future!

[volsung] 15/3/2018 08:19

Bought a few back here. Potential

[greendragon777] 15/3/2018 08:17

So far not having any material impact on the share price but maybe there will be a delayed reaction. That said it will be 6 months now before the interims so a pretty long wait from now!

We need to be patient now more than ever but one would have to be very optimistic now on a successful outcome for AP101!

[diamondstar1] 15/3/2018 08:14

There are strong positive messages from the trading update:-
1) 65 % annual increase in Lojuxta sales
2) In-licensing of gene therapy product for EB

BUT

Delay in EASE Ph III interim and final results. Interims now predicted to come in around early Q4 2018 (meaning Sept/Oct 2018) and finals in Q2 2019.

The scientific rationale for the delay is a very good one - which should increase the chance of EASE being positive. Essentially, they are excluding patients with EB simplex, who are most likely to heal spontaneously (following analysis of the recently failed ESSENCE Study with Zorblisa). This is especially important because the primary endpoint is at 45 days - if EB simplex patients were included, this would clearly increase the chance of EASE failure.

Amryt have done the right thing and made the right call in modifying the EASE study design.

The downside - a delay in EASE results, but a well justified delay - as much better to have a delayed positive study than a failed ‘on track’ study. My impression is that Amryt Senior Management made the right decision in the recent capital raise of 15 million Euro - as a ‘buffer’ for times like these, as this delay in EASE will also increase clinical development cost for Episalvan.

[greendragon777] 15/3/2018 08:11

Cash position is very healthy too! 👍

[solomon] 15/3/2018 08:06

The BOD have quite a vision for this company and plan to increase revenue to accommodate it.

[greendragon777] 15/3/2018 08:05

Overall very positive but yes a delay to the AP101 trial results obviously not expected. However it should increase the chances of success which is a major positive. It will only cost an additional €1m which is well worth it it in my opinion. Major coop getting the data from Amicus! 👍

The other things aren't of any major significance at first glance but I'll need to read it again.

Looking forward to hearing what Diamonstar makes of this, he'll put it into context hopefully! 👍

[bigwavedave] 15/3/2018 07:47

Yep, had very quick scan of rns. Looks good.

[superbobtaylor] 15/3/2018 07:42

Looks not so good to me. AP101 phase 3 results delayed.

SBT

[bazworth] 15/3/2018 07:33

Looks good to me, need some comments from more knowledgeable folk re the AP101 stuf....

Cheers

Baz

[greendragon777] 15/3/2018 00:36

If the news is dull Paps I'll just roll over and go back to sleep so it's a win win either way! 😁

Enjoy the golf Baz, you might have to play the 19th a good few times if the news is favourable.

Don't think too much over brekkie though....that can give you a headache especially at that hour in the morning! 😂😂😂

[bazworth] 15/3/2018 00:00

Hangover, hopefully not!

Deliberately moved my golf to a later tee-time to allow a little time for a lazy breccy and ‘thinking-time!

Cheers all.....

Baz

[papillon] 14/3/2018 23:33

What action? :-)

Go on, go to bed. NOW! :-)

You don't want too many Guinnesses otherwise you'll be up and down for a pee all night long. Though if the news tomorrow morning is dull (or even bad) then you wont mind to much because you'll have a monster hangover so wont give a toss about the update.

[greendragon777] 14/3/2018 23:18

Too many Guinness Bazworth and I might miss all the action in the morning! 😂😂😂

[greendragon777] 14/3/2018 23:08

Haha....I'm like that every night Paps! 😁

I'm defo looking forward to the news whatever it is because I'm hopeful it will be good news whatever it's related to. That said, if it's an update on Lojuxta basically stating that sales are ahead of forecasts then that will be a bit of an anticlimax because we all pretty much expect that given the rollout of it through the new distribution deals.

Anyway we'll have answers to all these questions in about 8 hours time. Let's hope it was worth all the excitement! 😁

[bazworth] 14/3/2018 22:51

Sufficient Guiness will do the trick!