Amryt Pharma Share Discussion Threads

[ultrasharp] 13/9/2020 16:08

Hi purple. Not the whole truth, purple. I've had another winner this year!😍
GPM. Initial purchase back in very early April @ circa 27p. That and AMYT are the only 2 shares I've bought and hold in 2020. How are yours doing?

ATB PAPILLON

[purple11] 13/9/2020 01:49

youre onto a winner atlast pappy!

well done and gl

[martin171] 12/9/2020 22:25

As previously announced on January 3, 2020, the Company sold approximately 1.55 million ordinary shares of Amryt, yielding net proceeds to the Company of approximately USD$2.0 million, with proceeds from such sale to fund anticipated ongoing operating expenses and to satisfy anticipated claims and obligations, as well as potential unknown or unanticipated claims or expenses.

The custodian holding the ADRs confirms that Novelion currently holds ADRs representing approximately 12.49 million ordinary shares of Amryt.

[bazworth] 12/9/2020 21:26

Well researched! Thanks

[ultrasharp] 12/9/2020 20:06

The new AMYT shares must have been distributed to the Novelion debt holders and shareholders, martin, before Novelion was liquidated otherwise how did Americans end up with 70% of AMYT shares after the RTO? Perhaps some Novelion shareholders kept their shares for whatever reason.
ATB PAPILLON

[ultrasharp] 12/9/2020 19:28

I was under the impression, martin, that most Novelion shareholders accepted the offer of AMYT shares in exchange for their Novelion shares before Novelion were liquidated. That would mean some didn't accept the offer before the liquidation. When I get the time I'll check out the relevant RNS's from the time of last year's RTO to see whether I'm right, or wrong.

ATB PAPILLON

[martin171] 12/9/2020 18:36

The liquidator didn't distribute any shares to NOVELION shareholder yet.A date is not set yet according to an email I received from the o6of the liquidator.

[ultrasharp] 12/9/2020 11:47

I think it's worth remembering that at the current share price AMYT can be considered undervalued on it's expected revenue for 2020 and projected growth rate.
Unfortunately there many American investors, both PI's and institutions, who received new AMYT shares in exchange for their Novelion shares and Aegerion debt respectively. Neither seem that interested, on the whole, in holding AMYT ADS's. Ever since AMYT floated on Nasdaq small ex Novelion shareholders have been selling their AMYT ADS's. Don't forget only those investors used to selling on an overseas exchange could sell their shares. The majority were unable to sell since last year's RTO.
I expect a 2nd wave before we get any further news, especially since that massive ADS's sell went through yesterday. That could have been overhanging the Market for a long time.
Whether this 2nd wave reaches the height of the 1st wave on Wednesday is anybodies guess.
ATB PAPILLON

[bazworth] 12/9/2020 11:44

So, in essence, we’re not quite there as yet!! I wonder why the partial data was released well before full knowledge is available?

[bazworth] 12/9/2020 11:22

Thanks, fingers firmly crossed then!

[diamondstar1] 12/9/2020 10:37

Firstly, my guess is that Amryt may be targeting the Dermatology Congress - EADV (being held between 28 Oct - 1 Nov) to disclose the full EASE results. I might be 100% wrong on this one, as there are other medical congresses around that time.

I can only speak on broad terms, regarding what may be potential challenges in the future. In all therapeutic areas and diseases, Regulators will have a sense of what is a Clinically Relevant improvement in Primary Endpoint. For EB, I must admit that there is scarcity of information on this, as no Pharma company has been through a formal approval process.

Let’s start with the very optimistic scenario for a Small Molecule drug - Episalvan shows a 15% improvement in wound healing vs. Placebo (p=0.013). If mean healing time in the Placebo arm is 14 days, mean healing in the Episalvan will be 11.9 days. Regulators will look at the combined efficacy and statistical significance value, and will likely look upon this very favourably.

A pessimistic scenario- placebo-adjusted efficacy is only 3% (p=0.013). This means that mean wound healing time may be 14 days in Placebo arm, while 13.58 days in Episalvan arm. This will likely raise questions on Clinical Relevance of the observed treatment effect.

If you are very familiar with previous Episalvan efficacy data in Partial Thickness Wound (PTW) Healing, you may be of the opinion that the efficacy data for EASE is likely to fall somewhere in between my optimistic and pessimistic scenarios. The question is whether the actual EASE Ph3 efficacy data it is favouring a more optimistic vs. pessimistic scenario. Regulators will, of course, consider the fact that there are currently no approved therapies for EB.

The EU filing has a clear advantage in that they have already granted Marketing Authorization for PTW. I have come across drug filings where FDA rejects, but EMEA approves, and vice versa. So, each regulatory filing will carry its own risk.

[alphabravo321] 12/9/2020 10:15

I noticed that Joe Wiley stated they had done 91 mill in sales in first 6 months, could push us over the 175 mill target by year end

[bazworth] 12/9/2020 09:48

Faster than a flying bullet......

[alphabravo321] 12/9/2020 09:43

Thank you Diamonstar for your excellent answer, Bazworth took my next question out of my mouth!

[bazworth] 12/9/2020 09:21

diamondstar1, thanks!

You explain things so well that even I can understand....!

Is there any chance that the additional data to be released will turn matters against us?

Cheers

[diamondstar1] 12/9/2020 08:56

Alphabravo, the P (statistical significance) value tells you how much the treatment effect (difference between active vs placebo) observed was simply down to chance. For example, if you flip a coin, there is a 50% chance you will get a head, 50% chance you get a tail. P=0.05 means that if you repeat the experiment (clinical trial) 100 times, in only 5 times you would expect differences to be detected between active and placebo, if purely down to chance. P=0.013 in EASE tells me that the treatment effect between Episalvan and placebo was highly statistically significant; we can be reassured that the treatment differences in the EASE trial (better effect of Episalvan on Primary Endpoint) is a real effect, rather than being a chance finding.

However, there is no correlation between the P value and the expected Treatment Effect. You may have a clinical trial with a highly statistically significant difference, but the Treatment Effect (difference between active vs placebo) may be smallish, example, 3%. Conversely, you may have a clinical trial with a large treatment difference, but these results may not reach statistical significance (p>0.05). The results are highly dependant on the selected endpoint, and also the standard deviation in the trial, which will be influenced by the variability of the data in both the placebo and active arms.

[alphabravo321] 12/9/2020 07:48

Diamond, is there a correlation between the ph of 0.013 and the expected % efficacy?

[richpassi] 12/9/2020 05:23

Hi Pap I reckon we are not the only ones who would wear that shirt. Wish I'd seen your late night post to help us sleep better ! I've been up since 4.30 am :( Amryt related ! .......of course not :)

[papillon] 11/9/2020 22:54

For what it's worth the candlesticks say keep holding. There has been no bearish pattern formed in the last few days. No doubt you will sleep better in your beds tonight following that insight!! 🤣🤣

[charlie_munger1] 11/9/2020 19:36

I think that the recent sell off is profit takers and once they get out the share price will hopefully start heading up. The next big news will surely be the outcome of the FDA application (outside of Q3 and full year results). If it gets approved then you'd imagine the European market will approve it also, or vice versa. I read somewhere that this process could take months and even until the end of 2021?