Amryt Pharma Share Discussion Threads

[sidam] 25/9/2020 07:52

Albundi and diamondstar
It is a real pleasure to read a thread on ADVFN, where there is an interesting and informed discussion. Please keep posting when you have more to say.
Thank you very much.

[diamondstar1] 25/9/2020 00:39

Yes, you are right Paps - there is always a possibility KB-103 could fail in Phase 3. But at the same time, what are the two main reasons for trial failure? 1) Poor efficacy 2) Poor safety profile. If you have such a highly specific treatment that is targeted towards the gene defect (COL7A1) - you will likely see great efficacy (similar to Ph2) as well as a good safety profile. Hence, the odds are actually in Krystal’s favour, compared to Amicus, which had a small molecule. Excellent for the EB patients - that so many potential treatments (including Amryt’s Episalvan) are being developed in this dreadful disease!

[papillon] 25/9/2020 00:02

Of course, diamondstar, it's always possible that KB-103 fails it's phase3 trial. After all Amicus paid a lot of money for Socioderm just to acquire Zorblisa which was about to start a phase3 trial. That trial failed.

[albundi1] 24/9/2020 09:29

Hi Diamonstar1. Your contribution to this board is much appreciated. I was reading up on your posts especially post 5901 and thought i would contribute to the information i have found. Going back to post 5901 i picked up on 3 points which i would like to offer answers which i have got together thanks to people in the know:

1. " Remember that EBS is the most common form of EB, contributing to 70% of the disease"

FEEDBACK : What i have learnt is 70% of patient numbers, but some estimate c.15% of the revenue model as these patients are not as severely affected and need less product

2. "Meanwhile, DEB patients often have a moderate-severe form of the disease and contribute to 25% of the total EB patient population"

FEEDBACK : Some estimate c.80% of the revenue model. Note Krystal is only studying in DEB and it is a different gene that is affected.

3. "My point is this - if Amryt’s AP-101 gets FDA/EMEA approval in early 2022 for DEB/JEB - with an assumed efficacy of 10%. How will this be impacted by KB-103 if Krystal gets approval for DEB (70% subset with COL7A1 gene defect) in early 2023, if their efficacy is far superior e.g. 80-90%?"

FEEDBACK : With all gene therapy products you need to consider cost, ease of manufacture, ease of storage and transport, risk of immunogenicity, etc. I encourage you to look at the KOL event AMRYT had in early August where the KOL reckoned both products would be used side by side and in parallel


Thank you

[bazworth] 23/9/2020 22:03

Flying off the shelves then!!

[papillon] 23/9/2020 21:49

Tiny volume of just 1042 ADS's on Nasdaq today.

[ultrasharp] 22/9/2020 15:12

Good volume so far on Nasdaq. Every trade, bar 2, @ 12.
ATB PAPILLON

[ultrasharp] 22/9/2020 12:39

Could see the start of a bullish double bottom form on the chart today. News must be due very soon. Hopefully very good news Fingers crossed.

PS We're not the only ones getting it wrong. Simon Cawkwell (Evil Knievel) was boasting recently he bought at 220p!!
ATB PAPILLON

[ultrasharp] 22/9/2020 12:35

Hindsight is a wonderful thing, bazworth. Unfortunately PI's fall in love with a particular share, or become greedy and fail to take profits when they should! Fact of life and unfortunately we'll never learn! Those, no doubt, selling this week could have sold almost 2 weeks ago for far more money.
ATB PAPILLON

[bazworth] 22/9/2020 11:44

If only we had sold at circa £2.50 then we could have hugely increased the number we hold!

[ultrasharp] 22/9/2020 11:27

Today's drop is not a surprise. I'm only surprised it didn't happen yesterday!!

ATB PAPILLON

[ultrasharp] 21/9/2020 17:21

AMYT share price is still overpriced on AIM when compared to current Nasdaq price. There is absolutely no interest in Amryt on Nasdaq.
Everything was well down today. Gold, FTSE, DOW, bit coin, WTI. All well down today. COVID 19 is definitely frightening investors.

ATB PAPILLON

[ultrasharp] 20/9/2020 20:51

Last trade on Nasdaq on Friday was priced @ US$12.07. That equates to 187p on AIM. Yahoo quote the same last trade price of 12.07, but give a closing price of 12.37. That equates to 192p on AIM.

So a sub 200p on AIM on Monday morning unless AMYT issues a bullish RNS. I'm clutching ar straws! lol

ATB PAPILLON

[ultrasharp] 19/9/2020 18:47

I meant to write US$60m, diamondstar, but on my keyboard the $ sign shares the same key as number 4. I didn't press the key necessary to access the $ sign so I got 4 instead. Silly me. I'll amend my post.

ATB PAPILLON

[diamondstar1] 19/9/2020 16:09

Yes, I agree with some of your points Paps... but Amryt’s cash position - isn’t it around $67 million?

[papillon] 19/9/2020 15:44

Another excellent post, diamondstar. However I keep harking back to the old proverb, ... "A bird in the hand is worth two in the bush". KB 103 is obviously likely to be a far superior product compared to AP101, but AP101 has completed it's phase 3 trial whereas KB 103 has yet to do so. It looks like phase 3 success will prove to be a shoe in for KB 103, but investors, including knowledgeable II's, thought the same about the FARN product which, much to everyone's surprise, failed it's phase 3 trial back in 2018. The share price crashed from circa 750p to circa 100p on the day that bad news was issued and subsequently dropped to under 60p.

PS KRYS's Mkt Cap is circa US$955m. That's circa £740m. AMYT's is circa US$383. That's circa £300m.

KRYS is stuffed out with cash. Almost US$300m according to the last time I looked. AMYT have circa US$60m of cash, but a lot of debt as well which KRYS doesn't have!

[diamondstar1] 19/9/2020 10:00

No problem, you ask great questions Paps.

Another question I was pondering over last night... is how Krystal’s KB-103 will now impact Amryt’s AP-101 Episalvan program? After all, KB-103 is now catching up quickly with AP-101. The Ph3 trial with KB-103 has started recruiting in August 2020. Like all gene therapy trials (or those involving advanced therapy medicinal products) - these trials usually recruit faster than expected because of the huge potential benefit for patients who have the specific gene defect. Simply my personal experience, as there are only 30 patients in this trial. I think that this Ph 3 will surprise everyone, with Primary Completion before Aug 2021. FDA/EMEA filing - I would expect in 2022, with potential approval in 2023.

Now second area to explore - how will the target market segmentation of AP-101 be impacted by KB-103. Let’s say, AP-101 files for approval next year, and gets marketing approval for JEB (Junctional EB) and DEB (Dystrophic EB). It will clearly not get approval for use in EBS (EB Simplex) as they decided to exclude these patients from EASE, based on the Amicus Ph 3 data. Remember that EBS is the most common form of EB, contributing to 70% of the disease, though this form of EB is usually milder, and disease burden is less (example, no skin scarring with EBS). Meanwhile, DEB patients often have a moderate-severe form of the disease and contribute to 25% of the total EB patient population.

My point is this - if Amryt’s AP-101 gets FDA/EMEA approval in early 2022 for DEB/JEB - with an assumed efficacy of 10%. How will this be impacted by KB-103 if Krystal gets approval for DEB (70% subset with COL7A1 gene defect) in early 2023, if their efficacy is far superior e.g. 80-90%?

My personal view is that KB-103 has now actually become a major competitor for AP-101 (despite the fact that the 2 gene therapies AP-103 & KB-103 are often compared). If KB-103 gets approval 1 year after AP-101, it will likely take over a very large market share of DEB patients with the COL7A1 defect, and potentially leave a small market segment for Amryt (DEB COL7A1 negative, or JEB patients). DEB COL7A1 negative will only be 30% of DEB patients, and JEB will constitute a minority of total EB patients.

Maybe... this partly explains the great enthusiasm in US for Krystal Biotech vs. Amryt Pharma’s lacklustre performance on the Nasdaq. Institutional investors often have a panel of experts and are likely to have performed an in-depth analysis of the EB market, and the individual clinical development programs.

[ultrasharp] 19/9/2020 08:31

Many thanks for that comprehensive answer, diamondstar. As always an excellent review of the current situation. I can now understand why Krystal Biotech is such a highly regarded investment with, as you state, knowledgeable American investors spoilt for choice.

ATB PAPILLON

[diamondstar1] 19/9/2020 01:26

Hi Paps,

People working in the Pharmaceutical Industry tend to use the clinicaltrials.gov website to get information directly. Simply google:- Krystal Biotech + clinicaltrials.gov + B-VEC. You should find the link posted on 29-Jul-2020. According to the website, the Ph3 study with KB-103 started in Aug 2020, and the targeted Primary Completion is Aug 2021. I would expect full results sometime Oct 2021.

The first link you provided (also on clinicaltrials.gov) was indeed the Phase 2 study, which has already provided the Primary Endpoint data. The reason why they are continuing the study till 2024, is to collect more long-term safety data on the patients who have already received study drug. With all viral-based gene therapies (in this case a Herpes Simplex Virus)- it is essential to follow up and evaluate for potential longer term effects on the immune system.

Hence, when Krystal complete their Ph3 in Aug 2021, they will have ~2 years worth of safety data from their Ph2 study.

Your question on whether American investors have greater enthusiasm for Krystal over Amryt - and whether this might be the reason why Amryt is performing poorly on Nasdaq? I do believe that Americans like Krystal Biotech’s STAR-D platform technology. This means that they can use their platform to target a wide array of diseases e.g. EB, Cystic Fibrosis etc. EB is the front runner for Krystal - if you look at their website - you can see that they have a robust pipeline. Pharma companies with great platform technologies - eg Alnylam (RNA interference) or Amgen (leader In monoclonal antibody therapies) tend to have the ability to develop winners over and over again, year after year. I don’t think Americans are choosing Krystal to invest over Amryt - I believe that Americans simply are spoilt for choice, and have so many great biotech and pharmaceutical companies to choose from, from an investment perspective.

I do consider that KB-103 for EB may be a potential ‘game changer’ - with phenomenal efficacy profile, and good safety. If Amryt succeeds in developing AP-103, it will likely be 3 years behind Krystal’s EB product. The general rule is that a second product on the market can only potentially achieve 1/5 of the sales revenue of the first product on the market, unless it has a major advantage or differentiator from the first product. Amryt will have to try to differentiate between their polymer based technology, compared to a more well established virus based gene therapy.

Finally, a company like Amryt - their business model is to acquire assets/companies or in-license drugs from other companies or universities. With this model, it could be more difficult to obtain a good platform technology, or difficult or expensive to purchase promising new drug assets.

This perhaps explains Amryt’s 300 million market cap vs. Krystal’s ~1 billion, despite the fact that Krystal does not have any marketed products, or any revenue from drug sales or partnership agreements.

[papillon] 19/9/2020 00:42

Many thanks for that information, diamondstar.

Well it looks like I was in too much of a hurry on Thursday with my 1000 share purchase. Unless we see a good news RNS on Monday morning (unlikely!) it looks possible that AMYT could drop back to below 200p on Monday morning going by AMYT's very poor performance on Nasdaq on Friday evening.

I wonder if American investor enthusiasm for Krystal Biotech is the reason AMYT is performing so poorly on Nasdaq?

PS According to this US government link, which I downloaded via the Krystal Biotech web site, KB103 is currently undergoing a phase 2 study and the estimated completion date is March 2024. There is no mention of a phase 3 trial yet on this US government web site. What do you make of this information, diamondstar?



Yet this statement from Krystal Biotech dated 28th July 2020 announced that the phase 3 study of B-VEC (new name for KB103) had been initiated. I find it all a bit confusing!

[diamondstar1] 18/9/2020 23:12

Paps - AP-103 has similarities with KB-103. Both require repeat dermal application on the patient’s skin - they are considered ex-vivo treatments. KB-103 utilises a Herpes Simplex Virus (HSV) as the viral vector. Much more is known about these gene therapies using viral vectors; there have been a few approved by Regulators, such as uniQure’s AAV-based gene therapy. Since Krystal Biotech’s KB-103 is already in late-stage Ph3 development, there is more known about this product, from a safety, efficacy and dosing perspective. For example, in EB patients, it requires once daily dosing on Days 1-5, then only 1 application at Days 30, 60, and 90. Both KB-103 and AP-103 are targeting DDEB (Dystrophic EB) ie patients with the COL7A1 gene defect (present in 70% of DDEB patients). I would rate Krystal’s KB-103 as having a very high chance of meeting Primary Endpoint for their Ph3, and getting approval. Krystal appears to be at least 3 years ahead of Amryt, in the race for a gene therapy targeting COL7A1 for DDEB.

[papillon] 18/9/2020 16:21

lol, richpassi

[richpassi] 18/9/2020 15:04

Pap it may only be 1 ads but its 5 whole Amryt shares lol :)

[papillon] 18/9/2020 14:58

Still only ONE solitary ADS traded on Nasdaq so far today. "You cannot be serious"! 🤣