Amryt Pharma Share Discussion Threads

[charlie_munger1] 06/9/2020 13:24

That would be glorious alphabravo321

[alphabravo321] 06/9/2020 10:51

So with a bit of luck in a fee months we could be sitting on 175 mill in revenue, circa 60 mill in cash with a potential sale of the review voucher at circa 100 mill not to mention downstream revenues for Filsuvez starting at 100 mill per year, put a valuation on that!

[papillon] 06/9/2020 00:29

I'd go along with your share price target prices, diamondstar, on success, or failure of the EASE phase 3 trial.

If AMYT hadn't merged with Novelion's Aegerion, Aegerion's bondholders hadn't accepted new AMYT shares in exchange for a large chunk of Aegerion's debt and if AMYT hadn't acquired the US$150m+ revenue stream from Aegerion then AMYT's share price could easily have plunged on an EASE phase 3 failure rather like FARN's did in May 2018, having been almost £9 a few months earlier. The FARN share price plunged from over £7 to around a £1 in one day following a phase 3 failure. That failure surprised the market. By early 2019 FARN had drifted down to circa 50p. However I have just noticed that the FARN share price is now back up to circa £4 having peaked in 2020 at around £5.

It's worth noting that when Amicus's SD101 treatment for EB failed phase 3 in 2017 (SD101 was acquired by Amicus when it took over Scioderm in 2015 for over US$800m, with circa US$230m upfront in cash) the Amicus share price barely moved on the news. Amicus, of course, had other promising irons in the fire apart from SD101.

[diamondstar1] 05/9/2020 21:37

Papillon- I agree with your comments. I see value at these price levels. The company now has a Market Cap of $364 million, with a projected 2020 revenue of $170-175 million.
Amryt is now a transformed company with 2 approved products and a US/EU footprint. If Ph III EASE fails, I believe 140p, will potentially be the base. If EASE is a success, I believe 250-300p will be the target. The benefit-risk is strongly in our favour this time round; certainly a much stronger company compared to the time Amryt released the interim results for EASE.

[charlie_munger1] 05/9/2020 20:41

Okay, thanks for the great insight diamondstar1

[diamondstar1] 05/9/2020 20:35

charlie-munger - the DMC have evaluated the effectiveness data in the interim analysis. The statistical analysis plan (SAP) for the trial would have pre-specified what to do with the data. If no difference between active (Episalvan) and placebo was seen - they would have had to terminate the study at the interim analysis. The fact that they allowed the study to continue - indicates that they did see some separation in efficacy - ie better efficacy in the Episalvan arm. I haven’t got a crystal ball with regards to the final results - but that is what the interim results tell me personally.

[bazworth] 05/9/2020 20:33

Magic information on here, thank you diamondstar1....!

[alphabravo321] 05/9/2020 20:31

Great response Diamondstar, Thanks very much for your insight

[diamondstar1] 05/9/2020 20:24

alphabravo - 10% in improvement in wound healing at Day 45 will be considered significant, especially for product in which there are no approved therapies. This is the Primary Endpoint that FDA and EMA have agreed with. An analogy for a layman - if I give you a paracetamol tablet for a high temperature, your body temperature typically drops 0.4 degrees Celsius. This represents a 1% drop in your total body temperature, but you feel much better after taking the tablet. Similarly, a drug can improve EB wound healing by 7-10% at Day 45. This may seem small to you, but the EB patients may feel much better on Episalvan therapy. Hence, Amryt will also be collecting secondary endpoint data e.g. Quality of Life data, to support benefits on a patient level.

[charlie_munger1] 05/9/2020 20:12

Duly noted diamondstar1. Any odds better than 50/50 I will take lol. I'm assuming the data monitoring committee has seen the interim efficacy analysis in other phase 3 trials and pulled the plug if they weren't satisfied?

[alphabravo321] 05/9/2020 20:06

I like our odds

[diamondstar1] 05/9/2020 19:57

Much better than you think Charlie-munger. A publication entitled Phase III Clinical Trial Failures: Costly But Preventable by Grignolo and Pretorius (2016) states a Ph III clinical trial success rate of 61-67%.
Of course, there will be minor variances in success rate depending on clinical indication, example oncology, rare diseases. But one advantage with EASE Ph III is that the Data Monitoring Committee (DMC) has already seen the interim efficacy analysis, and allowed the trial to continue, albeit with a recommendation to increase patient numbers slightly.

[charlie_munger1] 05/9/2020 18:39

I'm assuming the vast majority of phase 3 drug trials fail?

[alphabravo321] 05/9/2020 17:51

Thanks Diamondstar, I recall you discussing the efficacy profile of 101 before and although to a layman like me 10% seems low am I right in saying this is still a significant level in pharma terms?

[ultrasharp] 05/9/2020 15:18

Excellent post, diamondstar. Many thanks.

ATB papillon

[charlie_munger1] 05/9/2020 14:45

Thanks diamondstar1, I understand it now.

[alphabravo321] 05/9/2020 12:52

Diamond, if the trial is successful, considering Amryt have a significant sales manufacturing and support tram in place, what are your thoughts on how quickly Amryt could ramp up sales on Filsuvez?

[diamondstar1] 05/9/2020 12:36

Hi charlie-munger1,

I can provide some insight, as I work in the Pharma Industry. The value of FDA priority vouchers, in the current time, is approximately 100 million USD. For example, Astra Zeneca recently paid 95 million USD for biotech company Sobi’s voucher. The voucher recipient allows a fast track approval process, which saves the user about 6 months in time in the drug approval process. For a drug with an projected annual sale of 1 billion, this would clearly be worth a lot.

However, if Episalvan is successful in their Ph3 EASE, I doubt they would use the voucher themselves. If you have a projected annual sales of 100 million, it would be better to sell the voucher for 100 million. The FDA does not pay you any money, but allows you the ability to sell your priority voucher to another pharmaceutical or biotech company.

[charlie_munger1] 05/9/2020 08:46

I understand, thanks papillon

How much could the fast track voucher be worth? Does the FDA pay for it?
Would they not be better keeping it instead of selling it on?

[papillon] 05/9/2020 00:09

Actually charlie_munger1 I see it as a good sign! Why? Well those very large sells were overhanging the market, probably for some time. The MM's would be aware of that and have kept the share price higher than that on Nasdaq to enable that client (probably a favoured institutional client?) to offload 400k of AMYT shares without crashing the share price and hence getting a good price. They were probably "worked" trades where the sell orders were made up of smaller tranches and sold on the market over a period of time. The trade price quoted when the trades were reported after today's close was probably the average sell price over a period of time.

It's good to get rid of a large overhang of shares being sold and hence depressing the share price I believe the chart I posted earlier this evening to be correct and we will soon see a bounce back up. FINGERS CROSSED AS ALWAYS!

PS. I agree with alphabravo and do NOT believe the seller knows anything. I do NOT believe the trial results have leaked! Perhaps the seller was hedging his bets and only sold part of his holding today? We'll only find out who the seller is if he held more than a 3% stake in AMYT.

PPS. AMYT is currently undervalued so even if the phase 3 result is bad we shouldn't see too much share price downside. Anyway a large chunk of the future value of AP101 was divested from AMYT last year when those CV's were issued to AMYT shareholders on the register before the merger with Aegerion was completed. Where AMYT will lose out if the result is bad is with the potential value of the fast track voucher AMYT could sell on if the trial result is good.

[alphabravo321] 04/9/2020 19:59

I would say there are only 3/4 scientific people in the world that know the outcome of the trial

[charlie_munger1] 04/9/2020 19:47

Okay, thanks. Them being sells isn't a good sign, I hope someone doesn't know something we don't. How soon do you think before they release the results of this phase 3 trial that they know the outcome?

[bazworth] 04/9/2020 19:37

I occasionally do a dummy trade and that will determine the price to sell and buy.

Agree with papillon, the size of the share price fall would indicate that they are sells!