Shield Therapeutics Share Discussion Threads

[crankyman] 06/1/2020 09:31

No NICE or SMC opinion doesn’t help

[borromini1] 06/1/2020 09:19

2TD - I did not find the actual review comments, I assume they are not made public.

Just seems odd that the global reference for clinical trials still has NO RESULTS published a full TEN MONTHS after STX issued their announcement RNS on the head to head study on 4 March 2019 with Carl Sterritt, CEO boasting ...

"We look forward to presentations of the AEGIS-H2H data at upcoming scientific meetings and working with our commercial partners to ensure prescribers, payors, experts responsible for the publication of treatment guidelines and the many eligible patients are aware that Feraccru® offers a simple to administer, well tolerated and efficacious oral treatment alternative to IV iron therapy, without the need for hospital-based administration."

I also can not find ANY UK NHS Area Prescribing Committee making any reference to the head to head study results in published documents and Feraccru prescribing guidance. Only a footnote reference link to the trial on clinicaltrials.gov

I can find two staff vacancies at Norgine for key regulatory roles unfilled since last Aug/Sept.

[2theduke] 05/1/2020 21:33

Bromin could you find the review comments ? I went to the site but could not find them - do you have amore direct link?

Separately. Can anyone think why there has been no management update on the process given the prior mentions of q3 and q4 (or indeed “as soon as possible after fda approval” ) comments. I’m struggling to think why management would not issue a statement saying discussions continues.

[nobbygnome] 05/1/2020 18:57

>> borromini1

Short answer, no!

[best1467] 05/1/2020 16:28

Patience is key I don’t see not getting a deal done by year end as a negative on the basis if they had narrowed it down to say two potential partners quite quickly a deal could well of happened.
My gut feeling with the broad label approval the interest was greater and on that basis more interested parties taking longer to negotiate and the likelihood of a fruitful deal or even a takeover approach from a interested party.

[borromini1] 05/1/2020 16:26

What is this about ...

Results Returned after Quality Control Review
December 12, 2019



The date on which the National Library of Medicine provided quality control (QC) review comments to the study sponsor or investigator. The sponsor or investigator must address major issues identified in the review comments. If there is a date listed for results returned after quality control review, but there is not a subsequent date listed for results submitted to ClinicalTrials.gov, this means that the submission is pending changes by the sponsor or investigator.

Could the delay in STX getting the head to head study results accepted and published on the above US governmental web site be slowing down the Feraccru/Accrufer deal finalisation or even UK regulatory reviews?

[borromini1] 05/1/2020 12:12

NYB - European Patent Office, Teva patent challenge ... so STX responded on the last day of the standard 4 month reply period, the composition of the Appeal Panel was set in early December, did you gain any insight as to how long before the panel formally address the case and typical time scales for delivery of judgement?

Last July our friends at Edison marked down STX by 35 percent of their base case (82p per share) to give a valuation of 273 million GBP thereby reflecting their perceived risk to the patent. The converse being they will increase their base case figure by 50 percent if the patent challenge fails. That, according to Edison, is another significant potential uplift event bubbling away in the background.

[crankyman] 03/1/2020 22:12

I think the deal will come. It has to. I assume they will be in JP Morgan mid January so that’s the next timeline for getting it done.

[nobbygnome] 03/1/2020 20:16

What is that Buffet saying about investment being the transfer of money from the impatient to the patient.

A deal will most definitely come because they cannot sell the drug themselves. It is just a matter of time so if I was you I would hang on....but no investment advice intended.

[2theduke] 03/1/2020 19:49

Ah what was the rant? To be honest I’m now starting to get concerned with the timing and the lack of communication here. The sell and take the profits is now a question I’m considering. Shame nothing happened in q4.

[crankyman] 03/1/2020 13:49

Prefer to rant anonamously. Anyway, it out of his hands now. It's Norgine's product. What they are doing with it is not terribly clear

[ny boy] 03/1/2020 13:25

cranky, you could email Carl at Shield with your concerns?

[borromini1] 03/1/2020 11:42

250 GBX would be very nice. Otherwise difficult to calculate when still early days for revenue. As Edison stated on 26 July 2019 ... Successfully commercialising Feraccru/Accrufer through partners is now key to Shield realising its value ... We now value Shield at 273m.

Current market capitalisation = 210 million GBP
Number of shares = 117 million
Current share price = 180 GBX
After deal share price, say 250 GBX
After deal market capitalisation = 292 million GBP

Patent expiry 2034
Years for revenue growth towards substantial earnings per share, say 4 years
Subsequent investment pay back period, say 10 years
On the above basis to return original investment capital, someone buying in at 250 GBX might be assuming ...
Earnings total per year average over 10 year pay back period = 29.2 million GBP
Earnings per share per year average over 10 year pay back period = 25 GBX
To make any profit they need to see more than these figures or sell to the next believer.

Ferinject in market sales for 2018 = 900 million USD = 693 million GBP
Vifor Pharma Ferinject global sales revenue for 2018 = 380 million GBP
Vifor revenue to market sales ratio = 55 percent

Edison Feraccru/Accrufer peak in market sales figures
USA = 420 million USD = 323 million GBP
Norgine EU 5 = 130 million Euros = 110 million GBP
Total in market sales = 433 million GBP
Shield revenue to market sales ratio say same as Vifor at 55 percent
Shield peak revenue = 238 million GBP

Comments, additions and corrections welcome

[ny boy] 03/1/2020 11:22

Shield filed their reply to Teva’s appeal received electronically on 20 December, 11 pages, can view it on EPO web site putting in ref EP2668175 , click on all documents left hand side.

[nobbygnome] 03/1/2020 07:25

>> borromini1

Good to hear you have got through your scepticism. What price are you expecting post the announcement of a half decent deal?

[ny boy] 02/1/2020 22:59

Interesting big trades!

I guess we should hear something very soon....

The time limit for replying to the communication dated 20.08.2019 is 4 months plus 10 days according to Rule 126 (2) EPC, so probably on 02.01.2020 as the EPO is closed on the 30.12.2019 and first working day is 02.01.2020. Please notice that User Desk does not take responsibility for the complete accuracy of this information, the Registrars of the Boards of Appeal are responsible, but the date should be right.

As mentioned you can find all relevant bibliographic information in EP2668175:

Properietor is Shield TX (UK) Limited

Opponent, who filed the appeal, is Teva Pharmaceutical Industries Ltd.

This information is found on the main page of the EPR, under titles "Applicant" and "Opposition(s)"

You can choose to receive an email for every new document added to the All documents page of the EPR, this is called Dossier alert- Email. It simple to activate, but if you have many monitored applications and need to keep and overview Register Alert is more suitable.

Register Alert requires a quick registration. You can then log in to an account, edit your list and add comments etc. Register Alert sends emails for important events only and not for every new document as Dossier Alert.

[borromini1] 02/1/2020 21:48

Yep, back in over the last couple of months. Been adding in lumps.

[nobbygnome] 02/1/2020 19:12

>> borromin

You actually bought?😳

[crankyman] 02/1/2020 19:09

Whatever it was, it’s not new demand for the shares. It’s got to be a transfer between entities or something like that.

[borromini1] 02/1/2020 18:49

5.2 million shares, over 9 million GBP, reported after market close but both timed as 9:12:20.000 in the morning. I thought I was the big spender today until that happened ha ha.

New year first RNS a holding RNS?

[siriusbizness] 02/1/2020 18:26

That’s 45 x the ave volume. Is it anything to do with start of the month balancing or start of year share options being issued?

[nobbygnome] 02/1/2020 17:37

Wow. Five million shares traded in 2 lots today! Presumably one was a buy and one a sell...but which way round?

[secret investor] 01/1/2020 12:58

It’s possible that completing the US deal has been delayed for accounting reasons - that the US partner wants the costs to be recognised in FY 2020 not FY 2019. If so then we may get an announcement very soon...