Amryt Pharma Share Discussion Threads

[bioking] 08/1/2019 14:54

OT) Please look at Futura Medical (FUM) has a dirt low market cap of 19 Million and has 3 Drugs including a potential MEGA Blockbuster in Phase 3 for the treatment of erectile dysfunction which works way faster than market leaders like Viarga and Cialis . If you look for a potential 10+ Bagger then load up FUM stock alreay jumping higher check it out guys


Research Confirms MED2002's US$1 Billion Potential
hxxps://futuramedical.com/content/news/archive17/060317b.asp

The latest market research further endorses Futura's strategy of developing MED2002 as a prescription product in standard and increased strength dose forms, with the objective of switching the standard dose form to an OTC product at an appropriate time.

Ipsos's validated healthcare forecasting model was used to predict peak OTC annual sales for MED2002 in key countries worldwide in excess of US$650 million. This forecast follows earlier market research commissioned into the potential of MED2002 as a prescription product, which indicated a prescription market size of up to US$600 million in key countries worldwide.

Ipsos forecasts that 70% of OTC product sales will be incremental to the prescription ED category. As a result, the estimated peak annual sales of MED2002 in prescription and OTC versions is predicted to be more than US$1 billion prior to the expiry of the product's expected patent life.

The Ipsos valuation was based on the outcomes from primary market research carried out amongst 400 men with ED or suspected ED in the USA. The respondents were in four groups: satisfied users of PDE5 inhibitors (the class of drugs such as Viagra and Cialis); dissatisfied users of PDE5 inhibitors; diagnosed but untreated ED sufferers; and suspected though undiagnosed ED sufferers. The respondents were shown a concept about MED2002 as part of the market research though they did not use the product as it is currently in clinical development.

The key findings of the market research showed that the respondents believed that the product, once approved, is highly differentiated from existing products and that its claims would meet their needs. MED2002's rapid onset of action, an average of less than five minutes, was the key feature that attracted respondents to the product and could command a price premium compared with existing ED treatments, which have a substantially slower onset of action.

The Ipsos healthcare forecasting model has been demonstrated by Ipsos to be within 20% of actual sales volumes in 9 out of 10 of its forecasts.


Pipeline
hxxps://www.futuramedical.com/media/144144/Pipeline-2018.jpg

MED2002 (topical treatment for erectile dysfunction) hxxps://futuramedical.com/content/products/med_2002.asp

first patient dosed: in Q3/Q4 2018
Last patient dosed: by end of June 2019
Headline efficacy results: by end of December 2019

CSD500: Erectogenic condom
hxxps://futuramedical.com/content/products/csd_500.asp

Significant milestone achieved with approval of 2-year shelf life approved for CSD500, the erectogenic condom in September 2018. Development now complete. Discussions are ongoing with current and potential further distribution partners on next steps with the product in a number of markets.

Pain relief products: TPR100 (diclofenac) and TIB200 (ibuprofen) hxxps://futuramedical.com/content/products/tpr_100.asp

TPR100 commercial partner Thornton & Ross filed for UK regulatory submission in July 2018.
Out-licensing discussions for TPR100 outside of the UK are ongoing.

[diamondstar1] 08/1/2019 13:33

The increase in patient numbers has been performed to keep the statistical power of the study at 80%. This means that there is now a 80% probability that the Final EASE study will show a statistically significant (p< 0.05) difference between active and placebo. If the IDMC had somehow decided to keep the patient numbers in the study the same (DESPITE the observed treatment difference and variance in the EASE interims) this would likely have resulted in a lower statistical power (eg 70%) and therefore lower chance of study success.

[diamondstar1] 08/1/2019 13:26

Hi Mdalos. Yes, my calculations were based on the assumption that the treatment effect is lower than predicted i.e. an initial projected treatment difference of 10% would simply decrease to 8.9%, to support an increase in patient numbers by 38. This of course assumes that variance is as predicted. In reality, they have adjusted patient numbers based on variance data and ACTUAL treatment difference data from the EASE interims. So, variance could be slightly higher than predicted and treatment difference slightly lower than predicted. Thus, this is very reassuring that the treatment difference is still large between active vs. placebo. If the IDMC requested a doubling in sample size from 192 to 384 patients, then this would be very worrying, because this could mean that the treatment difference could decrease significantly. But my analysis shows that an increase in patient numbers by 38 has very little impact in decreasing treatment difference (assuming variance is as predicted).

[diamondstar1] 08/1/2019 10:10

What are the recent interim results telling me? Firstly, I would look at the sample size calculation for the EASE trial. This would have been based on 4 factors:- 1) The difference in treatment effect between active vs. placebo 2) level of statistical significance of the trial, usually set at 0.05 3) Power of trial, set at 80% 4) Variance (ie variability) of the Primary Endpoint data.
Therefore, there are only 2 possibilities that resulted in the IDMC need to increase sample size from 192 to 230: The variance was higher than predicted OR The treatment effect is lower than predicted.
Assuming that their initial predicted treatment difference was 10% (as seen in their Ph 3 PTW trials) and that their variance is constant, this means that the IDMC likely saw a 8.9% treatment difference in the EASE interim data, which prompted them to increase sample size from 192 to 230, to simply maintain statistical power at 80%.

What does this mean? It appears that EASE interims are excellent results, in my analysis. The IDMC likely saw a very large treatment difference favouring Episalvan vs. Placebo. Increasing sample size simply means a much higher chance of achieving a statistically significant results with the Final EASE results. People who understand this will appreciate that EASE interim results and I believe this will increase the chance of Amryt being a target acquisition from other Pharma or Biotech, especially with positive AP103 preclinical results! I believe that Amryt is still leading the race for the first product to be approved for EB, and a Pharma aquiring them at this stage is a low risk investment for them.

[alphabravo321] 08/1/2019 09:07

Or will the depressed share price invite a bid?

[papillon] 07/1/2019 23:31

Well the AMYT share price only needs to rise by about 45% before Friday for it to be worthwhile for the warrant holders to exercise their 24p warrants! LOL. Whatever made the AMYT BoD think that good news on AP101 & AP103 would make the share price rise sufficiently to ensure the warrant holders exercised their 24p warrants if they moved the final date for exercising them from 31/12/2018 to 11/1/2019? Were they poorly advised? AMYT is one share so far under the radar that even good news fails to light the spark that causes the share price to rocket upwards. Well we've had good news issued on Monday & Friday. Will we get a third piece of good news before Friday, or will the warrants expire worthless?

[papillon] 07/1/2019 15:25

3 large(ish) trades have gone through this afternoon that are all shown on the financial web sites as sells because they are below the arbitary mid price when in fact they are all buys, because one can buy even large(ish) amounts below the arbitary mid price. The 3 buys were for 100k, 65k & 50k. All done at 17p. The quoted spread is 16.60p-17.50p when in fact the actual bid/offer spread is 16.60p-17.00p.

[papillon] 07/1/2019 13:19

Great minds think alike! Let's hope we have picked good 'uns, spuddymadrid! Fingers crossed.

Only 2 big trades so far today. Both 100k sells and both at prices below the then current bid price. 16.5375p (value £16.54k) & 16.425p (£16.43k). They ensured that today's early share price rise following the AP103 RNS was very short lived. Hopefully they are the last of the big sellers out of the way and the share price can now start to rise again.

[spuddymadrid] 07/1/2019 13:02

I hold the same shares as you Papillon. Hoping for a good year. All about being leeping ones nerve. All three hold promise. Just need a bit of luck, good news and positive market sentiment

[papillon] 07/1/2019 12:36

Happy New Year to you as well spuddymadrid. O/T. I know you post on the PVR bb. I bought back into PVR first thing this morning. Only a small amount of money. I now have small stakes in both PVR & LOGP. I might buy more. I'm expecting (hoping!) both sp's to rise significantly in the short term.

[papillon] 07/1/2019 12:31

Bronxville
Posts: 712
Opinion: No Opinion
Price: 17.10
RE: Rns Today 11:18 Based on the 2 RNS's I'm flummoxed as to why they thought the share price would rally above the 24 threshold.
On reflection it would be extremely tough for 24 pence warrant holders to pony up again after Cathal Friel deleveraged at current levels.
And what of the elusive Alan Harris's 8 million shares??

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I presume that they must have thought that positive news on AP101 & AP103 (especially the former) would have pushed the AMYT share price above 24p, Bronxville. The AP101 news was issued to AMYT by a panel independent of AMYT. It's possible (maybe likely?) that AMYT were not expecting that this independent panel would want the trial size to be enlarged by 48 patients, Bronxville, when they changed the deadline for the warrants to be exercised from 31st December to 11th January in that 19th December RNS. There is no doubt that the enlargement of the AP101 phase III trial has curtailed PI's enthusiasm for AMYT. To get above 24p by Friday the big boys (II's) have to start buying now. And/or a preditor (such as Amicus) has to start buying a stake as a prelude to a take over offer in the future.

[spuddymadrid] 07/1/2019 12:14

Thanks very much Papillon. Happy New Year to you

[papillon] 07/1/2019 12:03

Thanks for the link spuddymadrid. I've changed the tt's to TT's to stop advfn turning them into xx's

[spuddymadrid] 07/1/2019 11:58

This article should create more positivity than the initial ones

[spuddymadrid] 07/1/2019 11:56

hxxp://www.pharmatimes.com/news/green_light_for_amryts_epidermolysis_bullosa_study_1274054

[spuddymadrid] 07/1/2019 11:56

hxxp://www.pharmatimes.com/news/green_light_for_amryts_epidermolysis_bullosa_study_1274054

[alphabravo321] 07/1/2019 08:12

Could be quiet now for a while

[richpassi] 07/1/2019 07:04

Can't moan about lack of news at amyt ! ;)

[papillon] 06/1/2019 15:26

Cathal Friel's Open Orphan gets a mention in the Irish version of today's Sunday Times. There is a small mention for Amryt as an aside.

hxxps://www.thetimes.co.uk/article/who-wants-to-be-a-plc-in-2019-ggdgstpzr


"Open Orphan, a Dublin-based company that is commercialising drugs for rare diseases, is also an IPO contender, with ambitions to raise about £10m (€11m) in a flotation in the first half of the year. Financier Cathal Friel, its co-founder and director, said the bulk of the equity was likely to be sourced from London-based institutional investors.
Friel, the owner of Raglan Capital, previously floated exploration group Fastnet Oil & Gas on the Alternative Investment Market in London and the ESM in Dublin. After Fastnet demerged its oil and gas interests in 2016, he engineered a reverse takeover of Fastnet by Amryt Pharma, an early-stage pharmaceutical group.
Until August last year, Friel was also a non-executive director at T5 Oil & Gas, an exploration group chaired by former Tullow Oil chairman Pat Plunkett that has repeatedly been linked with an IPO since 2017. The company came close to a listing on AIM and the ESM but deferred the decision because of delays renewing a licence for an key asset in Senegal.
It has acquired rights in Gabon and raised funds from existing investors late last year. In accounts signed on December 18, Plunkett said there was a “reasonable expectation” of an IPO in early 2019.
Like Davy, Friel said he felt fears about a hard Brexit were overdone. “I have a strong feeling there will be one last bit of compromise on the backstop agreement that will be enough for Theresa May to get her deal through the UK parliament,” he said. “Things are going to be much more optimistic this year and a number of the planned IPOs will complete successfully.”"

[alphabravo321] 05/1/2019 08:56

https://www.proactiveinvestors.co.uk/companies/news/211979/amryt-to-add-another-48-patients-to-phase-iii-trial-of-skin-disorder-cream-211979.htmlLast few paragraphs are interesting

[greendragon777] 04/1/2019 19:29

Thanks Paps, at least the bigger trades were reported as a buy! 😃

It's certainly the biggest trader we've had here for a while so will be interesting to see how next week pans out! 👍

[papillon] 04/1/2019 19:02

The 593k trade @ 17.25p was TIMED @ 2:41pm when the spread was 17-18p. There was a sell of 250k @ 17.30p just after that timed @ 2:52pm so I reckon that 593k trade was a definite sell, greendragon. The 500k trade @ 17.80p timed at 2:17pm was probably a buy because the spread at that time was 17.3-18p, also the previous trade, timed @ 1:37pm was a 100k sell @ 17.52p.

If they had both been buys then the share price would have ended up the day higher than 0.29%!

I'm definitely NOT going to clutch at straws!

[papillon] 04/1/2019 18:46

bazworth 4 Jan '19 - 17:26 - 4096 of 4098
0 0 0
mdalos1, you’re never stuck. You always have the option of selling. If you see better opportunities elsewhere, then sell AMRYT and buy the better opportuniy. It’s never wrong to take a loss, or indeed bank a profit!

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I totally agree with you, bazworth. It's NEVER wrong to sell a share you don't fancy anymore, even at a loss, if it means it saves you a far bigger loss in the future. It also means you free up some cash to invest in something that does take your fancy. Only novice investors are never prepared to cut their losses and take their money and run; that's why some still hold all their shares in companies that end up delisted, or worthless, such as CTAG & CRAW, or companies like LOGP & PVR where the current sp's are miniscule fractions of their all time previous highs. Of course LOGP & PVR sp's may well recover somewhat (in fact I recently bought back into LOGP as a good recovery play punt), but those who bought these one time high fliers near their peaks 6/7 years ago and still hold will likely never recover their money. Those PI's should have had a stop loss in place. They might then have lost, say 15-20% of their money rather than well over 95%.

My stance on the AMYT share price has gone from being cautiously bullish to being neutral after today's RNS. I'm now waiting for further news flow before I make up my mind what to do with my 39,000 + shares. Whether to keep them all, or sell some. Whatever I do I intend to continue to hold at least 20k. The short term direction of the AMYT share price could well depend on this AP103 update.

I hope I'm wrong, but I don't hold out much hope of another Lojuxta type licensing deal. I think a deal as good as that was a one off and due to Aegerions parlous financial state at the time.