Member Info for Muck165

And to add to the last point, developers will want experts who won’t screw things up and delay the process further. Stuart Angell (Ivdeology) is a member of the BIVDA Exec Board, vice chair of it regulatory affairs working party , and ex Novartis reg affairs manager.

Decent credentials.

lots coming out from both abdx and ivdeology recently about deadlines relating to the transition between the old regulations (ivdd) to the new (ivdr).

as i understand it any ivd’s that entered the market under ivdd rules must do certain things, by certain deadlines, in order to be able to meet ivdr regulations and stay on the market.

among other things this includes a requirement to have an ivdr compliant quality management system (qms) in place by may next year - 10 months away. the big difference here is that the ivdr qms places much more emphasis on life cycle management and continuous evaluation of products.

thereafter there’s application to be sent to, and agreements to be made with notified bodies by different deadlines depending on the device classification.

whilst all this all bores me to tears, it’s relevant to us because;

1. there will presumably be a glut of legacy manufacturers looking for reg support to put a qms in place and manage ongoing surveillance in the next 10 months. ivdeology can help with both.

2. the whole thing will put further pressure on the already sp**** numbers of notified bodies, and perhaps extend approval and, ergo, commercialisation.

3. it just shows how much regulation is involved. developers are usually scientists who don’t know anything about regulation, dont’ want to deal with it, but know it’s just as key to their commercial success as the product quality. so if they’re looking for a cdmo, one that can offer a full end to end service must be important i’d think.

Yep, and every indication from the Board that revenue growth will continue. Raise doubts entirely put to bed in my mind which leaves nothing to fear and everything to look forward to. Rare on AIM.

29 projects on the go as at March. We get paid development costs on all of them even if they fail to achieve market penetration. We stand to do well if any of them succeed, the demand and lack of competition means we can pick who we work with, and more join the hopper each month. And the Eco-Flo offering, which I am hoping for news on very soon, should attract even more business.

Mind me asking what tool you use for the info? I just have 2 on ADVFN but the info is pretty basic.

Thanks Teraferma - been watching the book and did wonder!

So, just a little more buying action and we might pop.

Just for info, but Dr Mark Jones has now been added to the speaker list, and will be speaking on 20 August for an hour at 13.10. What he will be speaking about remains yet to be announced, which does seem a little intriguing given that we're a primary sponsor of the whole thing. Cloak and dagger....

https://www.nextgenerationdx.com/point-of-care-diagnostics#MarkJones

New into the job, but the Health Secretary set out a vision yesterday which broadened the DHSC focus to include boosting economic growth by supporting the life sciences sector - it basically says healthy people = healthy workforce = healthy economy.

Whether that comes true or not, the intention to support businesses like us can only be a good thing.

https://www.gov.uk/government/news/secretary-of-state-makes-economic-growth-a-priority

Thanks guys, although I'm sure there are plenty who get fed up reading my drivel!

Some other thoughts...

Yates did an interview after the mediocre market reaction to the interims. Wonder if he will do another now?

Remain confused about why Salignostics haven't brought in more distributors. We have it. The Nordics have it. Why not the rest of Europe? Is it just down to country by country approval?

Lucksin - loved your cross ramp on the HE1 board!

For info, Yates posted about the results. Sometimes the more interesting thing is to note who reacted to it. This time round it included lots of people I've suggested we might be working with. Lets face it, nobody wants to appoint a CDMO partner if there are concerns it might go belly up.

https://www.linkedin.com/posts/activity-7216334111387328512-LqsG?utm_source=share&utm_medium=member_desktop

And in particular I noted the comment from Scott Page, who some might remember used to be our FD - he said "Congratulations Chris Yates and the rest of the Abingdon Health plc team. Great to see the story changing and evolving and the traction achieved in the last 12 months." Says it all really, and from someone who has more insight than any of us.

Have a great evening!

Yep, its the only reason I stuck a bit more in today.

Why re-arrange urgently unless you have something pressing to say?

Why bring the Commercial Director and not an Ops guy unless the pressing message is commercial?

I can't think of any commercial message that wouldn't be positive given where we are.

Graham has been the one joining Lorna in recent meetings with Govt officials, and in previous employment "played an integral role in the group’s major agreements, including asset acquisitions, farm-outs, production sharing contracts, and joint operating agreements"

But then what do I know!

And on the numbers, if we were to add in the £500k waived fee for FOFH then year on year revenue growth would have been nearer 65%.

I suppose I am just bewildered by the lack of value attributed to our potential, and in particular for a growing annuity revenue underpin.

We nearly doubled our annual product revenue, it seems largely because of just 3 products we got into Boots in Q4. And we don't even make 2 of them. If that is the case then even without any further growth or product launches, those products alone should generate over £1m a year. Add in growth, new retail product launches, and the real potential for NHS contracts for IDAP products like LVOne and Neutrocheck and the revenue underpin strengthens significantly. And that's all on top of our core development and regulatory propositions.

And its not as if new product launches are very far away.

For whatever reason though, the market isn't reacting to that potential.

Lucksin - when you search for the product on the Boots site a banner comes up to tell you how many times its been viewed/added to basket in the last 12/24 hours.

OK - so what's going on boys and girls?

To carry on with Apre's maritime theme, we are now sailing headlong and straight for superb fishing waters with a full tank of fuel, a very wide net, few other boats, a proven Captain and crew, a strong demand for fish, and soon to be a healthy profit on every fish we catch.

So I'm at a loss to explain the muted reaction today. Is it really that we are so under the radar? Or are Singer still offloading as Teraferma suggested a little while ago?

Can anybody see anything but upside here or am I just blinded by bias?

One other thing struck me, which was that product revenue in H2 was 176% up on H1, the main driver being the launch of Boots OEM tests.

But we only launched those tests in March, half way through H2.

Looks promising for the future, particularly if we support Boots with more offerings. And there I’m particularly thinking of the FOFH STI tests given ABDX has confirmed it will have rights to offer them as own label products.

Agreed Apre.

We’ve turned the tanker to cash flow breakeven (Q4).

Salistick is selling, and surely must be made available in other territories soon.

Hormona to release their test “in the Autumn”

Upfront in manufacturing, looking for UKCA imminently, and will I think have the NHS as a first customer.

Eco-Flo to launch by September

Perhaps something on the FOFH tests in Q3

All areas growing.

Raise risk now very low indeed.

Can’t really see a downside and can only attribute the muted reaction today as being off radar.

We should also remember that the numbers exclude the c£500k fees we waived to buy in to FOFH.

You would certainly hope so Apre! And for me things can only get stronger as we move more product into manufacturing.

The other point of note is that, like H1, every area of our CDMO service saw growth in H2.

ABDX have pretty much turned the tanker now. The biggest hurdle for us and customers remains the regulatory treacle.

Https://www.londonstockexchange.com/news-article/ABDX/trading-update/16557959

Try this..

Key points for me…

Cash Flow positive in H2

£1.3m current cash

Product sales now showing significant growth, which I think we can expect to continue.

H2 revenue of £3.6m (ex Ivdeology)

A good solid set of numbers.