Amryt Pharma Share Discussion Threads

[papillon] 17/9/2018 16:30

You going, greendragon? Early bird ticket £100. On the day £200. Not cheap! :-)

[papillon] 17/9/2018 16:21

Bronxville
Posts: 441
Opinion: No Opinion
Price: 17.25
RE: Krystal Biotech surging Today 15:15 Getting hammered big time!

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Krystal Biotech share price is going down because it's overvalued. It's pipeline is all at an early stage.

[papillon] 15/9/2018 15:57

Posted yesterday on the lse bb.

Bronxville
Posts: 440
Opinion: No Opinion
Price: 17.25
RE: EASE Fri 12:47 Alpha..the fact that they are having a conference call as opposed to a regular press release might be a signal.I would imagine they have plenty of data
now and why start an expensive trial program in the US if the data is negative

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Read the AMYT RNS's, Bronxville! The "expensive trial program in the US" was signalled in the RNS dated 15th March. The US "trial program" was always intended BEFORE the interim analysis results.

"Trial sites in the USA

In advance of interim results, Amryt Pharma anticipates filing an IND with the FDA to allow opening of US trial sites in Q3 2018 based on preliminary data from the study and the non-clinical study results.

The Company is also pleased to announce that non-clinical studies, requested by the FDA as part of an IND filing to open clinical trial sites in the USA, have recently been successfully completed. No safety signals or concerns were noted from the preliminary data and the Company is now hopeful that the combination of these studies, and safety data from patients enrolled to date in non-US EASE study sites, will enable it to request an IND to open trial sites in the USA, which it anticipates will be in Q3 2018."

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I go by what the company says in their RNS's, Bronxville. I think you are clutching at straws in your post!

[sidam] 15/9/2018 08:45

But we may get a progress report on the use of AP101 in TENS! Management has indicated that could be a large potential market and could be quick to get into in the EU.

[papillon] 14/9/2018 19:12

We're all dreamers, alphabravo, otherwise we wouldn't be invested here. If we were more rational investors we would be invested in Terry Smith's investment fund. I think all of us currently invested in AMYT are eternal optimists. However I think you and Bronville have gone too far with your idea that we could receive the EASE interim analysis by the end of this month. That goes against all the evidence from the company where the initial "early Q4", has gone to "Q4" and on Monday went to "by the end of the year".

[alphabravo321] 14/9/2018 17:12

Ah let me dream Papillon! I have been waiting 4 years for this bloody announcement! I do still think that the conference call after could be a sign that there will be something interesting in the results RNS...these guys said they have "very ambitious plans" for this year so maybe they might surprise us after all...I am an eternal optimist

[papillon] 14/9/2018 15:43

I see OMI performed very well again yesterday. The 1st Elliot UP wave was Monday. Then the pull back and then the 2nd UP wave yesterday (3rd wave of the cycle). Pull back again today. Will there be a 3rd UP wave (5th wave of the cycle)?

OMI peaked at 12.85p this morning. It was under 2p a week ago! That's what very good news does for a minnow like OMI.

[timbo003] 14/9/2018 12:24

David Allmond (Amryt CCO) gave a presentation in behalf of Amryt at the ShareSoc Investor Seminar last night, the presentation slides should be available in a day or two.

Given the proximity to the results, he could not say much that was new, but there were a couple of interesting Q&As, most notably this one:


Q: What are the main competitors to AP101 and Lojuxta that are currently progressing through clinical development?
A: Topical Diacerin for EB, Evinacumab for HoFH




Topical Diacerein is being developed by Castle Creek Pharma for EB and is currently undergoing clinical trials, it was granted FDA fast track designation in August 2018
A quick search reveals that Diacerin is approved as an oral medicine for the treatment of osteoarthritis in a number of counties in the developing world, it appears to have somewhat dubious efficacy and it has been around for decades. It does not appear to have any approvals in the developed world












Evinacumab (injectable antibody) is currently being developed by Regeneron for HoFH for which it has recently received FDA breakthrough designation





Note: Regeneron currently market Alirocumab (trade name Praluent) an approved treatment for certain patients with HeFH

[papillon] 14/9/2018 12:01

"are we in for a surprise early update?". I think the answer is a definite NO, alphabravo.

It just doesn't make sense. After all, initially we were told the interim analysis was to be announced in early Q4. Then the EARLY was dropped and we were told Q4. Finally, just JUST FIVE days ago we were informed "an interim efficacy data readout is due later this year". So in just FIVE days you think the interim analysis has gone from "later this year" to the end of September! That's just illogical, alphabravo. I see Bronxville on the lse thinks the same as you. I think both of you are just are clutching at straws and are ignoring what the company has been telling us this year and most importantly what it was telling us JUST FIVE DAYS AGO!

Back in H1 we were hoping for the interim analysis in October. Five days ago, after Monday's RNS, that expectation was more like December! Now you and Bronxville think it might be the end of September! That is just wishful thinking!

"Notice how the EASE timeline is missing from the blurb?". Why should it be on today's RNS? Why repeat something that was on Monday's RNS just 5 days ago? After all today's RNS is concerned solely with announcing when the H1 results will be announced.

I think there must be a reason why the H1 results are so late this year compared to 2017 & 2016, especially since we were basically given the H1 revenue and cash balance @ 30th June in the RNS of 19th July. What that reason is I just don't know. Hopefully it will be because they have other irons in the fire at the moment (if I was in clutching at straws mode I would hope it would be another licensing deal), but it definitely wont be the EASE interim analysis, UNLESS THE COMPANY WAS FIBBING just FIVE days ago in Monday's RNS! I don't think it was. :-)

[bazworth] 14/9/2018 10:38

Understood, thanks

It's all a bl@@dy long wait, isn't it!!

My hope is that they will announce, very soon, that they have another 'Lojuxta'!!

[alphabravo321] 14/9/2018 10:34

I realize that Bazworth, the point I was making was the details on timeline have been in several RNS' in a row and now they are missing that's all...

[bazworth] 14/9/2018 10:25

alphabravo321, there is no reason for it to be mentioned as the information they are releasing is simply the date of release of results. I admire your optimism!!

Cheers

[alphabravo321] 14/9/2018 09:57

Notice how the EASE timeline is missing from the blurb?are we in for a surprise early update? After all, my understanding is that the interim would be produced at a certain patient count rather than date, maybe they are ahead...wishful thinking on my part

[papillon] 14/9/2018 08:22

H1 results due on Wednesday 26th September. I wonder why they are so late this year? Especially since we were given H1 Lojuxta sales revenue and the cash position @ 30th June on 19th July. Strange. There's always a reason, but what it is I have no idea. I just hope the reason is good, rather than bad.

[greendragon777] 12/9/2018 17:43

Good point Paps, it's kinda damned if we do and damned if we don't either side of the interims if it's going to be anything other than a positive readout!

Another placing would be a disaster for the share price A loan would very much be preferable or perhaps a restructuring of the existing EIB loan if that was possible?

We're still on a cash burn though, that we know for sure! 🙈

[papillon] 12/9/2018 17:35

Just 2 trades today. For 3.5k & 2.5k. Both buys. Total? A pathetic 6k. No investor interest in AMYT. At least the 2nd trade was at full asking price of 17.50p.

[papillon] 12/9/2018 13:30

Yes, greendragon, but if the interim analysis proves to be inconclusive the share price would be a lot lower as a consequence. If then the interim analysis was inconclusive and AMYT decided to carry on with the trials, but to increase their size and scope then cash would need to be raised, but with a much lower share price. A placing at a much lower share price would be harder to get away and lead to much greater dilution. Would AMYT be prepared to take that risk?

Of course I have no knowledge of the current AMYT cash position and I have no idea of what AMYT intends to do with regards to it.

My reason for continuing to hold my 25k of AMYT shares is I'm prepared to gamble my circa £5k of cash on a positive interim analysis. I don't know the odds on success, or failure.

PS. AMYT might well be "confident of positive interims", but I presume they don't know how they are progressing because they are being conducted under independent supervision. In theory the interim results will be as unknown to AMYT as to us small shareholders; whether that's true in practice I have no idea. Perhaps AMYT do already know the conclusions of the interim analysis in advance? Perhaps data is being "leaked" to AMYT? Who knows?

[greendragon777] 12/9/2018 13:10

It sure is looking a bit tight Paps but I'm guessing they will wait until after the EASE interims as it should be a lot easier to raise the cash at that point. Perhaps they are confident of positive interims. They are kinda goosed anyway if they need to pull the trials for AP101 and will most likely need to fall back on Lojuxta sales and the other use cases for AP101. Perhaps they won't really need a huge amount of cash in that scenario too. We're calculating the cash burn rate which is effectively mostly being sucked up by the trials.....kill the trials and it should Kill the heavy cash burn.

I know it wmtdd be a great situation as a high growth story but in relation to immediate cash requirements it might not be all that bad. Just my 2 cents!

[papillon] 12/9/2018 12:33

At 31/12/2017 AMYT had 20.5m Euro's of cash. According to the July 19th update they received 7m Euro's from sales of Lojuxta in H1 2018. At June 30th AMYT had 12.2m Euro's of cash. That means AMYT "burnt" 20.5 + 7 - 12.2 = 15.3m Euro's in the first 6 months of 2018.

Assuming a similar cash "burn" in H2 2018 and a similar revenue from Lojuxta sales that could mean that AMYT would have just 12.2 + 7 - 15.3 = 3.9m Euro's of cash remaining @ 31/12/2018. It was mentioned by either Bermudashorts, or diamondstar, that cash burn could be lower in H2 than H1 because of upfront funding of the phase III trials, however if AMYT are now starting trials in the USA that could increase cash "burn" because of upfront funding requirements. It's also possible that Lojuxta sales revenue will be higher in H2 than the 7m Euro's of H1 which would benefit the cash position.

It's all getting a bit tight on the cash front for AMYT, especially if the EASE interim analysis is delayed again and is not released until Q1 2019. I don't expect that AMYT thought the cash position would be so tight @ the time of the 20p placing because they couldn't have envisaged being granted full access to the Amicus trial data and hence modifying and enlarging the EASE phase III trials.

Also if the interim analysis is negative, or if it proves to be inconclusive and the EASE trials have to be enlarged that would knock a big hole in the share price and make raising cash harder and with much more dilution if money is raised via a placing. Would AMYT be tempted to pre-empt any chance of bad news by raising money before the results of the interim analysis are published?

[papillon] 11/9/2018 21:56

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