Amryt Pharma Share Discussion Threads

[moorsie2] 06/3/2021 15:48

10 minutes of your time to understand the potential here ( from 1min30 to 11m30)

hxxps://www.voxmarkets.co.uk/articles/amryt-pharma-record-fy-2020-results-jog-concept-select-update-russ-mould-on-the-bond-market-shock-fed3c09/

[whatno] 06/3/2021 10:58

delta0091 - the FDA may take a view with regard to cost/benefit of a drug in deciding whether to grant approval. As an example, Cosmo Pharma got a knockback for Methylene Blue MMX on the basis of cost-effectiveness even though the EMA approved. However, that is not something Amryt needs to worry about. They showed a strong signal vs placebo.

Amryt will almost certainly get MA in 2021/22. However, there are other clinical trials underway in EB, notably Krytstal's phase 3 B-VEC trial which is a gene therapy that effectively "cures" EB by restoring collagen to the treated skin. Krystal has said they expect to file a BLA this year.

[thecynical1] 06/3/2021 08:17

Morning all! Can anyone remember what the original share price was? I mean for the previous "entity"...when it was listed...Fastnet?? ....getting old....😔8532;

[delta0091] 05/3/2021 22:20

Because there aren't any good alternatives.

[delta0091] 05/3/2021 22:17

FDA Approval Does Not Mean the Drug or Vaccine Works Well

However, a major caveat is that just because a drug or vaccine is deemed a success by receiving FDA approval does not mean it works particularly well. Why would the FDA approve something like that? Because there aren't any good alternatives. For instance, neither the antiviral drug Tamiflu nor the seasonal flu vaccine are particularly impressive. But, there's nothing better available.

hxxps://www.acsh.org/news/2020/06/11/clinical-trial-success-rates-phase-and-therapeutic-area-14845

[sidam] 05/3/2021 15:08

I got the impression from the presentation that management were in talks about distribution of new products. I would not be surprised if this was relatively soon. They stated that their strong preference was rights for North America and EMEA, but if only EMEA was available they would be likely to go for it.

That could be catalyst for next move, but November is not that far away. Fingers crossed!

[papillon] 05/3/2021 14:35

whatno, I accept FDA approval is odds on, but nothing is guaranteed. That is why the AMYT share price is not yet discounting that FDA approval being given!
Yes, bazworth, why raise that 40m? Surely it was to increase the cash coffers ready for an acquisition? Don't forget investors who took part in the placing got relatively cheap shares for that 40m they stumped up. Perhaps it was just a chance for some II's to build a significant stake in AMYT without pushing up the price by buying in the market? Just as rational and logical argument as the acquisition one.

[whatno] 05/3/2021 13:16

Papillon - I don't think there is much doubt that it will get approved. The Ease trial was very well designed so the FDA is very unlikely to reject on an efficacy/safety basis. The factor that most often causes an unexpected CRL is manufacturing. The FDA will normally perform site inspections at the plant where the drug is produced. During the pandemic, FDA has instead submitted written questions to the manufacturers about various aspects of their processes - it's like taking an exam - get a question wrong and you fail, badly! NDAs that are rejected the first time around for this reason normally make it through on the second attempt.

[bazworth] 05/3/2021 12:43

Mind you, there must have been something that floated the boat of those who fairly recently stumped up $40m!!

[papillon] 05/3/2021 12:16

Let's face facts. The AMYT share price won't jump up until we get FDA approval for the EB treatment and the company can then flog off the fast track approval for mega bucks (around US$100m?). When that FDA approval is received is anybodies guess. Hopefully it will be soon. Of course there is always the possibility it will not be given. Dread the thought!

[papillon] 04/3/2021 21:18

Let's hope that the Mail tips AMYT over the weekend. They usually do after a good results RNS. AMYT is one of their favourites for tipping.

[papillon] 04/3/2021 19:51

Sh*t on Nasdaq tonight. Not doing AMYT any favours

[whatno] 04/3/2021 16:00

AH yes, but securing approval from the FDA the first time around is not a trivial exercise as anyone that trades PDUFA dates will know.

I draw your attention to the share price of CorMedix - CRMD (NASDAQ) on Monday as an example of a company that received an FDA Complete Response Letter (CRL) vs the share price of KemPharm - KMPH (NASDAQ) that received FDA marketing approval yesterday.

PDUFA is an extremely risky time for investors and shares prices are absolutely devastated by a CRL. Anyone who does not understand this should not be invested in pharma.

In Amryt's case, it is true that because they have existing revenue streams, a CRL would not break the company but it would take at least 9 months to a year to secure marketing approval second time around. The CVR would have expired by then.

[sidam] 04/3/2021 15:02

In the presentation they said a decision was expected in November from the FDA and if positive launch would follow, but this was not included in guidance for this year. A decision in Europe was expected in early 2022. So initial CVRs should have value if the decision is positive and not delayed.

[bazworth] 04/3/2021 14:10

I understood that approval was expected around September?

[whatno] 04/3/2021 13:37

All good news but no real surprises. I would expect the next big catalyst for the share price will be acceptance of the NDA by the FDA, judging from recent FDA filing acceptances. Given that Amryt state they will file in Q1 and the FDA confirms within a month, we should be looking at some time in April.. In other words, pretty soon!

As a CVR holder, I have fingers crossed that Amryt will not get the knockback from the FDA either on filing or approval. If they do, the delay will probably mean the FDA CVRs will expire, by the middle of next year, I believe). I would be gutted after holding for so long!

[moorsie2] 04/3/2021 13:34

Very happy to be a holder

[bazworth] 04/3/2021 13:12

I’m happy - all going very well by the look of it and more growth to come. The share price may give us all a good ‘whoooooshR17; at some point. Not a problem to hold and be patient!!

[waterloo01] 04/3/2021 12:45

Call at 1.30 if anyone wants to listen in

[delta0091] 04/3/2021 12:39

cash flow is impressive .. $48m

[papillon] 04/3/2021 12:24

4p. 🤣 Let's see what happens when Nasdaq opens.

[babbler] 04/3/2021 12:21

And so the share price moves 1p.

[waterloo01] 04/3/2021 12:05

Joe Wiley, CEO of Amryt Pharma, commented: "I am very pleased with today's strong results for 2020 which demonstrate the very positive performance and growth that our commercial products are delivering, coupled with the significant progress we are achieving in our exciting development pipeline of new therapeutic drug candidates. Our business continues to perform and grow strongly. In particular, our revenue growth exceeded expectations and the fact that we turned EBITDA profitable has translated into a significant increase in our cash balances. Given the strong performance of our business in 2020, we are now issuing revenue guidance for FY 2021 of $200-$205 million which demonstrates our confidence in Amryt's prospects.

[bazworth] 04/3/2021 07:06

Results mid-day I believe!

[papillon] 04/3/2021 06:58

Let's hope it's a good one ab321.