Member Info for B2HS2L

From Z-COVID-19 (US ONLY) Instructions For Use - https://www.fda.gov/media/136309/download refers:

"1.Intended Use
The Primerdesign Ltd COVID-19 genesig® Real-Time PCR assay is a real-time RT-PCR assay
intended for the qualitative detection of nucleic acid from SARS-CoV-2 in oropharyngeal swab
specimens from patients suspected of COVID-19 by their healthcare provider. Testing is limited
to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C. §263a, to perform high complexity tests."

Note the assay is only for use in 'laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.'

Many if not all EUA's issued for Covid-19 assays can only be used in a lab, and it must be for the FDA to watch and learn what new approaches to PCR testing are achieving outside a lab with the likes of PROmate, and to act to deregulate where necessary.

I know you know this Van, - some new arrivals probably don't.

It would be very helpful to know which products are in the pipeline for EUA approval right now.

Not to my knowledge Shaun.
Neither has it been discussed since 17th March RNS.
Fridays 'R&D and UK operational update' discusses dates when new and updated products are due to complete development, but this subject is not discussed.

This is exactly the sort of development that will maintain larger biopharma interest in a buyout, because it is so unique, and I don't know of anyone else developing PCR technology for use out of laboratories to this extent.
All to play for then, just need remind Boris and Macron not to veto any welcome interest.

Hi Ad4you -

"The reason I say this is at the start of the pandemic last year Primer Design sent products to Egypt on at least 2 occasions via the UK Government."

My recollection about sending tests to Egypt via UK Govnt was that the tests were in (part?) payment for PPE being supplied to UK from Egypt, - and I agree it happened twice.

If the UK Govnt are to pay for any such assistance, then the ball is in their court.

From Fridays RNS:
"An RUO assay to detect a new variant originally identified in India is expected to be launched in the next week and reinforces Novacyt's leadership in responding to an urgent public health need and market requirements. "

So the way that sentence is crafted leads me to believe that someone (if not GM) has contacted Indian authorities to schedule a response, and hopefully to agree some staff training on products prior to a delivery. You can't reinforce Novacyt's genomic leadership if you don't act when a product reaches the end of development.

It may be that GM would have been in contact with officials in UK to discuss Indian supply.

++++
Not sure there is truth in the rumour that Boris has a Bat-phone on his desk linked to GM's mobile phone.

Perhaps the vehicle in the cartoon starring GM driving past palm trees was a batmobile.
That really would make the basis of a fine cartoon.

I think the time for negotiating contracts is passed WBAFC.
They take to long for both parties to agree, and India doesn't have time.
I'm sure GM would be happy to agree a price and accept credit card payment.
There are no options or choices to make when ordering an assay.

I think Westlands helicopter manufacturers got to signing several helicopter contracts with the Indians,
but each time they wanted a last minute discount that was not agreed.

Apologies if already posted :

Coronavirus pandemic star Novacyt back in demand after it reveals it will roll out a slew of new Covid testing kits

https://www.thisismoney.co.uk/money/markets/article-9505025/MARKET-REPORT-Pandemic-star-Novacyt-demand.html

Hi Wilson, - Yes I have a shortlists for both USA manufacturer and distributer, but I guess there are quite few on this board with shortlists..

FlushFrank -

Development of two-gene target test was introduced to make the COVID-19 test suited to
these markets in the 4th Sept 2020 RNS :
France, Belgium, Croatia, Poland and the UAE.

Reproducing my post last night at 21:01:

From todays RNS:
"We look forward to the opportunity to expand our support of diagnostic testing in the UK through our established infrastructure and building a long-term future in this important market, as well as in international markets as we continue to invest in our direct commercial operations."

Could have been better written, but I think GM is saying that international markets are next for direct commercial operations.
From that I don't think he is talking about sales through distributors :-)

++++

Does anybody else have a different interpretation of GM's statement, as I'm keen to see how else this can be interpreted.
I think it's typical GM obfuscation that works a little to well to hide true meaning, and I think we will be wiser if we can explore all possibilities.

++++

Yes we have seen the vacancies being filled, to 'establish infrastructure and build a long-term future in (the UK) market'. However, once this market has been set up and running sweetly, with recruits doing a necessary job week in week out, might we then move on to direct sales to the next most important international markets?

Can't see GM hanging around with this if it is a correct interpretation.

Successful implementation of direct overseas sales carries implications of FTSE250 or NASDAQ membership?

Why put up with sp manipulation if a safer haven can be found on a more heavily regulated exchange.

neil -
From todays RNS:
We look forward to the opportunity to expand our support of diagnostic testing in the UK through our established infrastructure and building a long-term future in this important market, as well as in international markets as we continue to invest in our direct commercial operations."

Could have been better written, but I think GM is saying that international markets are next for direct commercial operations.
From that I don't think he is talking about sales through distributors :-)

Novice, -
You could spend the weekend researching in this document, - and hopefully you might contribute soon.
https://www.dropbox.com/sh/jtgl2ffh6lv34ww/AABCsFP3cATopsJTbhJEwOc4a?dl=0

Still baffled as to why the 09.04.2021 RNS was posted at 12:30.
It's usually done to coincide with the opening of US markets, - perhaps there is hidden meaning in the timing.

Wilson -
..and how long will it take oddo to issue a new note, - and will they wait for the next dip to put the boot in?

WRT the partnership to develop the antigen 15 minute LFT test.
It would be helpful if this partner was a manufacturer with plenty of LFT skills and experience, and decent size production capacity, but not necessarily in the UK.
Lets hope this is what we have partnered with, else route to market will be a lot slower.

Greggs -
"As you say a purchase of a leading diagnostics company would not be unexpected. NCYT have a large cash pile.....may as well use it to drive more cash."

Just think about how much R&D spend there must have been to generate an RNS so full of new and updated products.
Plus more spend on Chartwell services getting these assays to market ASAP.

I would love to think the next RNS will contain M&A news, but I'm thinking the cash pile hasn't grown sufficiently, so is it enough for Anthony Dyers plans?
IMO M&A activity may have to wait until Q4.
OK Graham - I've said it, - so that's your que to make me wrong, - after all WTFDIK

This RNS proves that competitors can't keep up in terms of R&D, or speed to market.
Didn't think I would see such a large array of new and updated products in one NOVACYT RNS.
Topping up soonest!
Well done GM, thanks for sharing!

But good news will make the sp rocket, and using your tactic Hydr, you won't be holding.
I'm not talking about a new product announcement.
I'm talking about H1 M&A activity, or a large contract,
or as seems a little more plausible these days through GM silence, - a buyout.

Yes EXMEX, I did see that, and it struck me that the government were thinking even at end of September 2020, that those lighthouse labs run by thermo-fisher etc were going to have their contract curtailed, and Covid-HT would be used instead.
Exsig Mag is also on schedule 5 page 81.

Video found here

https://www.youtube.com/watch?v=amjoVe7ihck

Part 2
54:00
In terms of M&A strategy - we do actually have some short term targets, and that's largely as part of our vertical integration strategy. (Turned out to be IT-IS International).
We will have more medium term larger accretive revenue and profitability generating targets which we would plan to focus on probably during the first half of next year.
So we are very clear we are looking at building the business rapidly with the transformative nature of our cash position.

57:00
Shareholder questions, (not all the questions asked are below):

Can you explain the plans for current and future manufacturing capacity, and do you foresee any supply chain constraints?

Today the company has no supply chain constraints for the product demand it is currently experiencing, and has capacity for it strong order pipeline including the phase 1 contract announced this morning.
We have built and maintained a high manufacturing capacity with flexibility which allows us to create levels of inventory meaning we can react to demand when it arises.
We are prepared for contracts such as the contract we received this am.
This contract took a significant time to negotiate.
++
Are there plans for products in the covid-19 range after the latest anti-body release?
We are continuing to innovate covid-19 testing, and more broadly for respiratory and transplant clinical diagnostic markets we will address unmet needs in these markets as the demand for testing continues.
++
How do you see the competition, NCYT USP, and what risks and opportunities do you see as CEO in the next 12 months?

The market for covid-19 is estimated to be $70 Billion this year, and that figure excludes any value associated with covid-19 testing.
Some analysts are reporting that for next year covid-19 testing could be anything between 25 bil and 40 bil US dollars worldwide, therefore the opportunity for this company and many others is very high,.
I believe there is room for everyone, and for many more different technologies whether they come from NCYT or others.
In the short term, I believe the single largest risk for NCYT is developing our infrastructure fast enough to continue the rapid rate of innovation and the delivery against the demand we are seeing.
By doing so we will continue to transform the business and build a long term foundation with which to create value for shareholders.
++
How is the development, the sales of NCYT and Primerdesign Covid-19 tests going in the US?

Today the US is one of the top performing countries, for sales, but given the scale of the opportunity there, there is significant growth for more.
To maximise this opportunity we are looking to strengthen our presence in the US market, where as today we only have one employee.
We will be doing that through a combination of organic investment and possibly M&A.

Part 1 - Excerpt from NCYT AGM 29 Sept 2020

NCYT vision: To become a market leader in respiratory and Transplant clinical diagnostics

25:00 mins - Anthony Dyer:

"We have chosen to invest heavily in building a strategic level of inventory because that allows us to respond rapidly to any demand anywhere in the world, so a selling point of ours is not only can we make significant amounts of this stock but we are also able to deliver quickly wherever need is identified.

...Capital expenditure in this business, as with many in diagnostics is not a strong feature of the business.
This year we have not spent, nor have we needed to spend significantly on capital expenditure, and part of that is explained by the fact that some of our expansion is through use of subcontractors, and where we have expanded our internal manufacturing, that has largely been done by finding efficiencies in our own processes."

46:30 - Graham Mullis
Today the diagnostic market is worth over $70 Billion and is growing very rapidly (BIS research; Global In VItro Diagnostic Market, July 2020),
We believe therefore that Novacyt is very well positioned, with its strong financial fundamentals and its strategy to be able to capitalise on the new focus that is being brought to bare on diagnostics.
In terms of our investment in R&D we are very clear on which market segments we are going to work on and will be developing a 5 year plan with a number of pipeline opportunities to exploit
the opportunities that we see in the respiratory and transplant markets.
We also plan to invest and establish a direct sales force in a number of key markets, so today NCYT has a single sales force and are direct in UK only.
Through a combination of our investment and targeted M&A we will be looking to expand our direct presence in a number of these key markets.
We are looking to add revenues and add to the profitability of the group.
By doing this we believe we will offset and hedge the risk of loss of covid-19 revenues at some point in the future, I would hasten to add that we do not see this happening short term
and believe Covid-19 testing will be with us unfortunately for some time to come.

We will also be looking for specific assets or acquisition of assets that will allow us to create further strategic value.
This may mean additional products that we acquire or mean specific assets that provide improved vertical integration and the control of the business going forward.