Definitely is progress if all NICUs in KSS adopt, though still only represents 6% of UK total.
They have been adopted in Manchester but as I remember so far just three NICUS adopted in the Manchester rather than all 8 in the Manchester area.
But would say, fact KSS appears to adopting bodes very well for eventual full NICE recommendation, in which case all 208 NCIUs in UK would HAVE TO adopt.
In my view two good products. But awful financing solution currently in place. Long lead times getting big commercialisation though that could improve with new financing to get it into US market.
"The original revenue from the NHS was upgraded long ago from £5m to £8m"
Perhaps they basing it on 90,000x£85 then now (given price inflation) then. That would nearly bring it to £8m
And then also of course is the question of how long it will take to get to complete UK penetration.....
90,000 babies a year are admitted to NICUs in the UK. Original business plan assumed only those who would definitely take antibiotics would be tested, and I think that came up to £5.5m in revenue.
But if all 90,000 are tested that means UK potential revenue of about £7.2m (£80x90,000)
Of course, given cash burn of £400k per month and assuming 50% margin GDR still wouldn't break even with UK market alone. In best case scenario that's £3.6m in operating profit versus yearly cash burn of £4.8m. Further reinforces the point why company is currently focusing on trying to get FDA approval and get product into US.
Yes, of course, it's the same trust. I think it means potential revenue from whole of KSS is about £750k per year versus about £500k per year if it was just for babies that were definitely going to have antibiotics
Rud,
You make an excellent point. Certainly, the modelling I remember previously in GDR presentations was about testing only those babies that were definitely going to be taking antibiotics. Question for me, is as yet they've made no mention of the other units in their same trust adopting it (only the Brighton unit thus far).
Would expect the big trades will RF at work, continuing to sell their wares. As a result, it keeps them below the significant shareholder rule, so the assignation of the trade doesn't turn up in an RNS. But their business strategy isn't about owning a company or even investing, so it's not because they're taking a fundamental view. With this sort of volume, would expect they'll be another drawdown in early Feb. Probably GDR would go for 600k again. Unless of course, GDR decides to mount/manages to organise a proper fundraise before then.
There's 13 neonatal units in KSS so that would be equivalent to about £500k per year revenue for GDR if adopted for routine care across all them all. Should help to pursuade IIs to invest in a fundraise would think. If demand here, has to be more demand in the US
The point being Jimi, that RF won't agree to a drawdown unless they think the volume is good enough. Why would they? They obviously not here to accumulate shares.
I think that side of it depends on the volume. If volume drops over next couple of weeks (it's not very high today), then GDR might have trouble getting another drawdown in early Feb. On the other hand, they might well announce they're doing a fundraise. Would expect maximum price level is going to be about 5p based on current share price, assuming a traditional AIM type fundraise.
I was pretty sure RF have been continually selling their shares all the way through this since last year. Otherwise, they would have appeared on the shareholder register as a significant holder long before now. They still haven't due to them always selling off the shares and hence never having a large enough stake to have to go on it.
Bighammer,
It not necessarily cheaper or more expensive, it just depends on what the FDA says has to be done. For example, if it was De Novo and it cost $2m to get it all done, for example, $100k would go to the FDA and $1.9m would go to a contract research organization (CRO) firm to do the product testing on US soil.
Not sure what you mean by "De Novo" route. It was always De Novo as that just means there's no comparable product already in the market. We know that because GDR's baby test is the first of it's kind.
Two years ago they said in a presentation it would cost £2m. And now they say they need to look at funding options to do it. Personally think the mention of the word "partners", (as plural) means they are going to need a proper sales organisation in every US state to sell it as things over there definitely need to be sold rather than just "distributed".
They said pre-submission process ongoing but this line does suggest that they think the cost is going to be a considerable amount:
(from results): "We are now looking at funding options to take us forward for FDA approval for the MT-RNR1 product, with substantially all of the exploratory groundwork completed we are ready to proceed to the next step."
It's because you can't sell in significant quantities (big sales) in UK or Europe until it's written into national guidelines that hospitals have to buy the product. It will take about 2.5 to 3 years before that starts happening. This is why GDR has stated that they need to go for FDA and USA now. In US it's more about "partners" selling it to private health firms. You just need FDA approval first, which should cost GDR at least £2m due to having to prove product on US soil first.
On the positive side, the trading volume is pretty good for GDR. If it keeps up like this they might get agreement from Rf to do another drawdown in early Feb. But the volume isn't really great news for shareholders because RF sells into it and dumps the shares. Currently, they have £1.3m in the bank with another £800k on the way through a tax credit within the next couple of months. The problem is they'll still need to tap some kind of funding to get product into US even if they somehow keep getting drawdowns from RF. With basic cash burn of £400k per month, they still only just chugging along.
FDA application itself costs far less than that. But you usually have to do testing on US soil, which costs money. A couple o of years ago,GDR gave an estimate of £2m to do that work. It could be a bit more than that now given inflation, though there is a downturn in this particular industry going on at the moment, so maybe it could be roughly the same.
Perhaps it's more to do with the outcome as they're going for a jury trial by the sounds of it. And also personally doubt the motivation for getting it transferred to Illinois from Texas is just about "efficiency."