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Even Eton are calling it an Orphan drug; (from Eton website)
Eton Pharmaceuticals Announces Availability of Orphan Drug ALKINDI® SPRINKLE (hydrocortisone) in the United States
November 24, 2020
ALKINDI ® SPRINKLE is now exclusively available through AnovoRx Specialty Pharmacy . To support patient access to ALKINDI ® SPRINKLE, Eton has established the Eton Cares Program ® . DEER PARK, Ill. , Nov. 24, 2020 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON), a specialty
https://ir.etonpharma.com/news-releases?a9d908dd_year%5Bvalue%5D=2020&op=Filter&a9d908dd_widget_id=a9d908dd&form_build_id=form-oco8-vUVCqz0d88RUC2vnWnou13rMMbdOjtFJLPXOv4&form_id=widget_form_base
This FDA website lists as Orphan
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=213876 (select one of the drop down boxes).
It seems very unclear, no doubt confirming orphan status is just a formality - but these milestones should have been clearer.
Thanks Balanced, the details of that payment just seemed a little opaque to me - I believe it had many other posters here confused too as many were looking out for that milestone payment.
It seems a little odd to me that DNL would let Eton sell the product, but not take the milestone payment.
You are correct though, it is in both RNS (although it's not at all clear).
ATB
I was not sure about this line in the recent fundraise RNS (in particular the section between ** **);
"As at 31 March 2021, the existing cash and cash equivalents (unaudited) held by the Group were £18.0 million. In addition to these cash resources, the Company currently holds 379,474 freely transferable shares in Eton Pharmaceuticals Inc ("Eton") that were received as part of the upfront consideration for the exclusive licence agreement of Alkindi® Sprinkle in the US. **Diurnal and Eton are also awaiting confirmation of Orphan Drug Status of Alkindi® Sprinkle from the FDA, which will trigger a $2.5 million milestone payment to Diurnal**."
This seems inconsistent with a previous RNS (following), posters on this board have long been waiting for a milestone payment from ETON on the first sale of Alkindi, the following RNS is poorly worded IMO. I am not sure if there have been any US sales.
This was the RNS from September 30th (the day of US approval for Alkindi)
"Diurnal has partnered with Eton Pharmaceuticals for the commercialisation activities of Alkindi® Sprinkle in the US, including pricing and reimbursement. Eton will initially use product from Diurnal's European Alkindi® supply chain, with an option to establish its own supply chain in the US in the future. As previously announced, under the terms of the licensing agreement, Diurnal will receive a $2.5m cash milestone payment upon first commercial sale of Alkindi® Sprinkle in the US following grant of Orphan Drug Status. The Company will also receive a tiered royalty on sales ranging from low double-digits to high teens and is due tiered sales-based milestone payments of up to $45 million in aggregate subject to annual sales thresholds. These payments are in addition to the upfront payment of $5.0m received by Diurnal upon signing the contract with Eton in March this year."
Hi Hunsen
The passage you have highlighted mentions getting the $2.5m on notification that Orphan Drug Status has been granted by FDA so it won't be on first sales unless ODS has been granted as well.
The last earnings call from Eton mentioned they are selling.
Hi DD77, the main flag for me is the following quote;
"As at 31 March 2021, the existing cash and cash equivalents (unaudited) held by the Group were £18.0 million. In addition to these cash resources, the Company currently holds 379,474 freely transferable shares in Eton Pharmaceuticals Inc ("Eton") that were received as part of the upfront consideration for the exclusive licence agreement of Alkindi® Sprinkle in the US. ****Diurnal and Eton are also awaiting confirmation of Orphan Drug Status of Alkindi® Sprinkle from the FDA, which will trigger a $2.5 million milestone payment to Diurnal."***
The section highlighted by *** in particular, I thought this was already long resolved, the question for me is are Eton even selling Alkindi yet? There was a milestone payment due on first sales but nothing so far. This was mentioned a few times on this board but has been overlooked now due to Chronocort / Efmody news.
A delay in sales / orphan status? Does this mean we have been burning cash for months? DNL have been tight lipped on early US sales.
HunSen - what are those red flags out of interest?
Olderandwiser, I'm not looking to get back in lower, I have been holding this share since it was 24p, and I have taken previous placings as they were at a reasonable discount at the time.
Like goosedeye, I am not looking to accumulate.
There are a number of decent posters on this board who are happy to discuss the company in detail and who also realise that eight posts on a board like this don't actually move the market (up or down).
I also appreciate R&D costs money, but there were a couple more red flags in the RNS which are a little concerning.
ALB
I am not looking to accumulate any more; I am waiting the next uptick to get out. Maybe look again in a few years time.
I think there are a few posters on here who would like to get back in lower.
I think the director slice of the placing is weak, possibly MW may pick up 10K shares which again is insignificant given his overall remuneration from Diurnal. We will soon be back to where we were last year given a 17% dilution.
I've enjoyed good success in buying AIM biopharm stocks at or below a recent placing price, especially when insiders also bought into that fund raising. Say no more here.
HunSen correct think a lot have forgot that 17 percent - IM fine here but other pharmas out there as well . IT seems dnl are very quick to raise money of late . WE only raised not so long ago and another thing a few posters think there will not be another fund raise think again . Hunsen stx are going to start selling in usa .Might be worth a look and ixico
HunSen.
As far as I see the fundraise is part and parcel of an R&D company transition. These funds will enable them to unlock another very important market.
This happens without exception in R&D pharma companies as the big pharma outfits with plenty of cash reserves won’t take on the risk.
It’s never nice to see this dilution but if the company is set up and run well then you should have confidence that the dilution is paying for the next step up in the companies growth.
In the rns they mentioned having meetings with the fda about a spa which will if given cut down the P3 trial time by possibly a couple of years. This is something to look forward to.
Those are my pre coffee thoughts!!
Another fundraise was expected, but this one is at a minimal discount, this is good for the company (cheap finance) but not so good for shareholders.The current shares in issue are 138.3m, on a market cap of £96.8m , that's 70p per share (the price today).The placing plans to raise £20m through issuing some 28.5m new shares, this takes the new shares in issue to 166.8m.That's a big chunk of the current issue, what concerns me is that if nothing happens to improve the market cap, the new share price (market cap / number of shares) will be 58p. I'm struggling to work out how taking part in this fundraise is good value (for small shareholders or institutions). My only thoughts are as follows;- there is imminent good news which will raise the market cap- the USA opportunity will be on an accelerated approval (current estimate is 2025 for approval)- DITEST is also estimated for 2025, so I don't understand the delay on EfmodyPlease correct me if I am wrong, whether you take up this placing or not - your shares will be diluted in the same way due to the lack of discount (the dilution is around 17%).Any thoughts?