Novacyt S.A. (EPA:ALNOV)
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Earnings Call: H2 2022

Apr 27, 2023

Operator

Good afternoon, welcome to the Novacyt full- year results investor presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time by the Q&A tab situated in the right corner of your screen. Just simply type in your questions and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company will review all questions submitted today and publish responses where it is appropriate to do so. For the benefit of those joining us from France,

[Foreign language] Bonjour, et bienvenue à la présentation aux investisseurs de Novacyt. Tout au long de cette présentation enregistrée, les investisseurs seront en mode écoute seulement. Les questions sont encouragées et peuvent être soumises à tout moment via l'onglet Q&A situé dans le coin droit de votre écran. Il se peut que les présentateurs ne soient pas en mesure de répondre à toutes les questions qu'ils reçoivent pendant la réunion. Toutefois, ils examineront toutes les questions soumises aujourd'hui, et y répondront dans le cas échéant. Finalement, je voulais juste expliquer comment faire apparaître les sous-titres en français. En haut à droite de votre écran, il y a deux lettres C, et si vous cliquez dessus, vous pourrez sélectionner les sous-titres en français.

Before I begin, I'd like to submit the following poll. I'd now like to hand you over to James McCarthy, Acting Chief Executive Officer.

Good afternoon to you, sir.

James McCarthy
Acting CEO, Novacyt

Thank you very much. Good afternoon, everybody. Welcome to the 2022 full year annual results. I would just pause on the disclaimer. If we just go back one. Sorry. Just please pay attention to the disclaimer. We will take that as read, but I think it's an important page for the document which will be put in the public domain. My name is James McCarthy. I'm Acting Chief Executive for Novacyt since November of last year. I've been, prior to that, CFO from January 2021. I'm delighted to be joined today by Steve Gibson, who's the Group Finance Director. Maybe I'll just hand over to Steve to introduce himself before we proceed.

Steve Gibson
Group Finance Director, Novacyt

Yeah. Thank you, James. Good afternoon, everyone. Steve Gibson. I've been with Novacyt for 7 years now. I joined just prior to the IPO. Prior to that I worked for Hewlett Packard for about 12 years. Thank you.

James McCarthy
Acting CEO, Novacyt

Just in terms of the format, Steve and I will run through some slides today, try and give you a summary of how the business has been performing and the key actions looking forward. At the end, we will pause and deal with questions. I'd like to just maybe do a quick recap of the vision and capabilities of the business. I know for many of the long-term holders, they will be familiar with this, but there may also some new voices out there. The origin of Novacyt, the Primerd esign business, was an RUO business that really was incredibly successful for a couple of things.

Its agility to react to the needs of the market, its speed to market and the quality of the reagents it produced. That was underpinned by a bioinformatics capability, which meant that not only could they spot what was happening in the marketplace, it was also key to design, you know, diagnostics products that were highly successful. As the pandemic hit, the business really shifted from being a core RUO life science business to a clinical business, because many of the COVID assays were clinical products. That really was the first foray, if you like, into clinical products. The business learned a lot in terms of product development, commercialization and regulatory et cetera. The group also acquired the IT-IS International business along the way in October 2020.

That brought an instrumentation capability into the company which the business hadn't had previously. We're now really putting all of those capabilities together to leverage the post-COVID landscape and try to build a leading global clinical diagnostics company. Go to the next slide. 2022 has been a key year of transition for the business. I mean even though COVID sounds like a distant memory to most people now, for the Novacyt business, for Q1 in 2022, we still had pretty substantial sales from COVID products. Pretty much for the first half of 2022, we were developing products for the COVID portfolio. We had six further CTDA approvals during the course of 2022, most in the first half of the year. Bringing our total approved portfolio to seven.

Which look, is something we're very proud of and I think something that shows the underlying capability and ability of the business to build leading products. It became clear in Q2 2022 that the COVID sales fell rapidly, and that really triggered the beginning of the transition. That meant a shift in development terms towards the non-COVID portfolio. Really pouring our energies into developing the non-COVID menu, and also looking at our costs. Look, as we work through the year, the first couple of products to come out of that internal development is a gastrointestinal bacterial product, closely followed by a gastrointestinal viral product, which we're working on. They will be the first two internally developed clinical products.

That's supplemented by a deal we did with an Italian company, an Italian molecular company, where we distribute some of their molecular products, which is to give us a broader menu as we start on our journey of commercializing clinical diagnostics. We also did quite a bit of work in our RUO, I mean, the original life science portfolio. The RUO business, which has been the founding part of the Primerd esign business. The RUO business suffered really during the pandemic. I think it suffered because the market was looking elsewhere. I mean, there was a lot of resources developed towards COVID, but also internally. I mean, I think the Nordisk business also deprioritized RUO, or at least the priorities were overtaken by focus on COVID.

We've been rebuilding that towards the back half of 2022. That includes refreshing the, the top products to make sure everything's up to date, working a lot on our supply chain to increase our response. We feel we've made a lot of progress in reestablishing that business. Finally we had to, you know, we had to address our cost base in 2022, and address it fairly aggressively. That included the disposal of the Microgen Bioproducts and Lab21 businesses, plus some significant change to the cost base of the Primerd esign business. And that was entirely necessary. I think as we face into a different future, we need a different cost base going forward. I think we have now done the heavy lifting and right-sized that during the course of the year.

Just maybe lastly, in this section to talk about business development. Business development is a catchall for us that covers pretty much all third-party partnerships. There are some clear evidence where we've been building partnerships. I mean, I've talked about oartners on the assay side, but we've also built partnerships in developing our workflow, so partnerships to develop extraction systems, partnerships to develop the liquid handling. When you put that together, we now have a workflow that goes from, you know, I guess sample extraction through to liquid handling. So sample preparation, the thermocyclers which are in-house to develop to deliver, sorry, a total workflow for clinical customers. I think that's very, very important that we have. It's a really good demonstration of us working with third parties.

We also called out our work with Eluceda, which is... Okay. It's not the biggest project, but we worked with Eluceda last year to do a proof of concept for a biosensor product. This is a, obviously a non-PCR diagnostic solution. I think it's important for us to keep a fairly open mind on alternative alternative systems. We're now moving forward with that relationship and targeting a couple of products, one in a non-human health, which we hope we could develop within the next 6-9 months and have in the market in 2024. I think it's a very exciting product. I mean, the whole biosensor platforms are very, very interesting in terms of the sample to result, you know, the time involved at low cost.

It could be a very exciting application in the right circumstances. Look, I think M&A, and I'll come back at the end, business development also includes more strategic M&A, and it's not something we've taken our eyes off of. I think, you know, it's clear we have cash. I think we also need the right partner for the business. I think valuations have been problematic for a lot of the start of last year. I think a lot of that has now leveled off. I think the field is leveling. I think we're confident we can actually put that capital to work going forward. I shall now hand over to Steve to talk through the financials.

Steve Gibson
Group Finance Director, Novacyt

Thanks, James. Good afternoon, everyone. Hope you're well. It's great to be here today to chat you through the 2022 financial results. As you read the financial statements, please remember that the results of Microgen Bioproducts and Lab21 Healthcare have been reported on a separate line, Loss for discontinued operations. That's in accordance with IFRS 5. That's for both 2021 and 2022. If we kick off from a revenue perspective, we reported revenue of GBP 21 million for FY 2022. That was in line with guidance. That is a decline from the prior year of GBP 92.6 million. That was driven predominantly by a decline in COVID-related sales.

If we look at revenue from a product mix perspective, around 70% of our revenue, which is over GBP 14.5 million, came from COVID sales, and around 30% of our revenue came from our RUO business and our instrument business. That was a decline year-over-year, and that was driven by lower instrument sales compared to 2021, which benefited from COVID-19 demand. If we look at revenue as well from a geographic perspective, what we remain is a well-balanced and International business. What you'll see is that the U.K. region generated around 50% of our revenue, which is over GBP 10 million, and that's because we have our largest direct sales force presence on the ground in the U.K. Other regions, Americas and the U.K. and Europe, sorry, excluding the U.K., both generated around 20%.

The remainder, 10%-12% was derived from Asia-Pac, the Middle East, and Africa. One point to note is that post the closure of Lab21 and Microgen Bioproducts, Primerd esign, our Molecular business, now represents around 93% of our overall group revenue. That's important because it's our most profitable business. From a gross profit perspective, we reported GBP 5.7 million or 27% compared with GBP 28.2 million or 30% in 2021. The 2022 gross margin was impacted by significant levels of operating stock as a result of COVID sales declining quicker than we expected, and this diluted the gross margins significantly.

If we exclude the impact of these one-off items, which totaled approximately GBP 7 million, the underlying gross margin of the business would have been in excess of 60%, which is a key metric for us going forward. James mentioned it earlier, we're on this journey of right-sizing the cost base of our business, and our OpEx costs fell by over 20% from GBP 25.1 million down to GBP 19.3 million in 2022. The main driver for that was the group-wide restructuring program that we undertook. This reduced the headcount of our continuing business from around 240 at the end of December 2021, down to around 137 at the end of December 2022. A reduction of over 100.

Our current head count is around 120 at the moment. We also saw further savings in legal and professional commercial insurance and facilities as the business contracted. We did manage though to protect some of the front end of the business. We continued to invest in R&D. We saw a 9% year-on-year increase in expenditure, taking it to over GBP 5 million. That's important because product development and innovation are, you know, critical to the continued success of our business. From a profitability perspective, we reported an EBITDA loss of GBP 13.5 million, versus an EBITDA profit of GBP 3.1 million in 2021.

The swing from EBITDA profitability to an EBITDA loss was driven by significantly lower sales and therefore a reduction in the gross margin contribution totaling around GBP 22.5 million, which we managed to partially offset by a GBP 5.8 million reduction in OpEx costs. This meant that the group reported a loss after tax from the continuing operations of GBP 22.2 million, compared with a loss of GBP 6 million in 2021. In addition to the EBITDA loss that I've just discussed, we also reported exceptional costs of around GBP 7.7 million, and that was made up of three key items. The largest by far was a GBP 5.2 million goodwill impairment charge associated with the IT-IS acquisition. The next largest charge was GBP 1.3 million restructuring expense that predominantly covered redundancy payments.

There was GBP 900,000 of costs in relation to the ongoing DHSC contract dispute. Taxation of GBP 2.1 million is predominantly as a result of the movement in the deferred tax balance. If we just jump back to the discontinued operations, that's reported on the separate line, loss from discontinued operations, and it reported a net loss of GBP 3.5 million for 2022. Out of that GBP 3.5 million , about 50% or GBP 1.8 million is closure related costs, which are non-cash impacting items. There's two main drivers in there. The first one is we recognize the GBP 1 million impairment charge in relation to the Camberley facility lease.

We actually surrendered that lease in January of this year, saving the company over GBP 1 million in cash, had the lease ran to term. The other big item in there is a GBP 0.6 million impairment charge for the remaining property, plants, and equipment that we couldn't utilize in the wider business. Overall, this resulted in the group reporting a loss after tax attributed to the owners of GBP 25.7 million. Next slide, please. Moving to the balance sheet, we closed the year of GBP 87 million of cash in the bank, and that was compared to just under GBP 102 million in 2021. This provides the company with a strong platform for which to execute its future growth strategy. Importantly, we remain debt-free as a business.

Goodwill, as I touched on earlier, has decreased year- on- year, that was driven by the impairment associated with the IT-IS acquisition. From a working capital perspective, excluding cash, that fell by just over GBP 2 million down to GBP 16 million at the end of 2022. That was driven by falling revenues that reduced the trade receivables balance. The actions that we took in relation to COVID-19 stock that reduced inventory and the payment of the remaining 2017- 2020 LTIP scheme that reduced trade and other liabilities. From a capital expenditure perspective, we incurred costs of GBP 0.4 million in 2022, that's a much better indicator of our future runway as a business compared to 2021, where we incurred over GBP 4 million of expenditure because we heavily invested in in-sourcing manufacture.

That was a quick run through of the 2022 results. More detailed information can be found on our website where we've published today the group results. I'll now hand back to James. Thank you.

James McCarthy
Acting CEO, Novacyt

Thank you, Steve. Phil, if you just advance to the next slide. Thank you. Just a quick reminder of how we think about strategy, and how we think of the journey we're on. You know, we look at four pillars of the strategy, the first one, product development, and here we talk more about reagent development. This is about building clinical menu. The second pillar is instrumentation. You should also think here of probably instrumentation and workflow, because it's not just the hardware, it's the process from sample to result, which involves instrumentation for sure, but also software and you know, connectivity across those different platforms. Geographic expansion also calls commercial for me. Commercialization, the obvious one, you know, developing these products and but finding a customer base for the products.

Finally, business development, which is I think I already mentioned is for me all things, third party partnerships, of various sizes all the way through to, say more strategic M&A. If we just move forward, I'd like to just give you some of the highlights under the different pillars. I'll try not to have too much repetition from the full year highlights. There'll be a little bit, apologize for that. I think it was just good to give some context of progress against the pillars and how we think about it. When I talk about building the reagent portfolio, I talked about the GI viral bacteria, which are the in-house developed ones and what we've done with third parties. We've also launched Winterplex.

There is still COVID testing going on. It just tends to happen now as part of a broader winter panel, of flu AB, RSV, typically is the types of panels. We're very pleased to get our Winterplex product launched last year. CTDA approved for U.K. sale in October last year. We've been selling that successfully in the U.K. and in Europe, even though we're a bit late to the season because of the U.K. CTDA coming so late. That's quite a good example of us commercializing a clinical product.

I think also, we have a unique strength with our RUO heritage, if we look at clinical development timetables, since May last year when IVDR came into force, we've gone from a system where you could probably do an IVDD product in maybe 6-7 months. An IVDR product is something like 2 years. That clearly changes the game. You know, it makes it much more difficult for certainly smaller diagnostics companies to bring products to market. We're using our RUO experience to build a set of initially RUO products, diagnostic products, but guided by the targets we came out of the market research we did last year.

We're taking those key clinical areas where we feel we can be competitive, and we're developing RUO typically multiplex diagnostic products in those target areas. That's something I think you'll see in our updates. That's something we can do in fairly short order. You know, we've set ourselves a challenge of up to probably 10 products during the course of 2023. They are products we should see as RUO multiplex products that we can develop and get in front of some customers and get more experience. I'd love to think that all of those will, you know, go down an IVDR route later on. Let's wait and see what that looks like when we have a bit more market experience with those products.

I think it's important that we can use our RUO credentials to kind of turbocharge that clinical development. And I think that's going to be super important for, you know, for clinical customers. Just on instrumentation, I mean, I talked a little bit about the partnerships, you know, a mixture of internal instrumentation knowledge, particularly in thermocycling, plus the external liquid handling and extraction to build workflow. Look, we're looking to develop our thermocyclers further, again, onto the theme of multiplexing, so upgrading our Q42 instruments, so that it can deal with multiplex products, more complex multiplex products, which is where the market is going. In fact, I think it's become almost the basic entry level. You have to have multiplex assays now, so we're gearing up for that.

I think the fact that we've CE marked both water instrument or sorry, instrumentation, we've CE marked our liquid handling. We're about to CE mark our extraction system. Again, this is very important for clinical clients because that's again the minimum they want. They want to see a CE marked solution, which is great. Next slide, Phil. Talking about geographic expansion, I mean particularly commercialization. I mean, commercialization in the post-COVID world is a very different, very different from what we experienced before. This is a much tougher journey, not least of all as I've talked about the lead times in developing products, but also clinical products typically, you know, constantly need to validate. In some way we had the experience of some of that during COVID as well, but it's a slightly longer runway to do that.

That's something we're engaging head on. It's very important for us where we develop clinical products. We're finding customer partners who we can work with. I think also it's worth talking about RUO. I mean, RUO, we need to also try and make a shift in RUO from more, I would say academic, and that's, like, only where we sell from more an academic market to a more industrial repeat market, repeat business market. Look, we all want to have this repeat more predictable sales profile rather than, you know, just a series of lots of individual projects going on, which has probably been more the characterization of RUO historically. We certainly have the capabilities, we believe, to deliver those services.

Just finally on business development, you know, as I said, to repeat business development for me is how do we deploy our cash with third parties? That, as I said, can be I mean, the overarching objective here is to accelerate the strategy, right? How can we deploy our cash to accelerate the strategy? The examples so far of building workflow solutions, building extraction solutions, that's an example of us working with a third party in a business development capacity and accelerating our strategy. The work we've called out with biosensor, so the biosensor work with Eluceda, and that's again, trying to look at an opportunity where we could accelerate our strategy, perhaps in a non-PCR area. Go to the next slide.

Maybe just to leave you with a couple of key messages. You know, the three things we have to demonstrate to you as we go through this year are we accelerating development of the portfolio, right? I think I set out some of the direction we're going there, and we'll come back to you later in the year and let you know how we're getting on. You know, can we drive commercialization? Can we commercialize the portfolio we have in the emerging portfolio successfully? Can we put our capital to good use in business development? Those are kind of three things that you should measure us on as we go through the year. I've also put in there the cost base. I mean, we don't wanna lose sight of our cost base.

I think we've done pretty significant work last year on rightsizing the cost base, but we continue to challenge ourselves to make sure there's value for money, given all the moving parts of the business. I think when you look in Q1 2023, we were posting sales of GBP 1.7 million, of which GBP 0.3 million was still COVID related, which is obviously a fraction of what COVID has been historically, but we still see a low level of COVID, coming through the door. Look, we were disappointed with revenues in Q1. There was some overhang in the instrumentation business. We've always reported that the instrumentation business is non-COVID.

Clearly, I think for simplicity, but clearly, when you look into that industry, I mean, there was a lot of instrumentation went into the market during COVID, right? From all sorts of different sectors. I think we're having a little bit of a hangover from that, and we hope to work through that as we get through the balance of the year. Generally, we need to drive, you know, the rate of COVID, sorry, of RUO and instrument sales and improve that for the rest of the year. Plus, we should see some more clinical sales coming through the back end of 2023. I think with that, Phil, if just go to the next slide. Look, I'll just leave you with this picture. I think we're ready at this stage to deal with any questions.

If I hand back to Mark, I'm not sure which one of you guys is going to-

Operator

Yes. James, Steve. Thank you very much for your presentation. Ladies and gentlemen, please do continue to submit your questions just by using the Q&A tab, which is situated on the top right-hand corner of your screen. Given the significant attendance on today's call, the company will not be able to answer every question, We'll start off the Q&A session with this one here, which reads as follows: What performance milestones can we expect in the next 12 months?

James McCarthy
Acting CEO, Novacyt

Thanks. I think I probably just mentioned this a little bit. I think the three pillars would be product development. You know, coming back to you specifically with what products are we developing? What stage are they at? Are they at the RUO stage? What's the journey to IVDR? That's a very clear metric. Commercialization will be certainly in what sales we're posting. What actual sales we're posting, but also, you know, do we have line of sight of contracts as we develop our sales plans towards the back end of the year. M&A progress will be. Yeah, I mean, M&A is always a difficult one. Clearly, bigger projects are by definition something we don't discuss openly. You know, this is something we're working on very hard.

You know, I'd love to be in a position we come back to you later in the year and actually demonstrate, some moves in that area. And hopefully we can. I think it'll be very clear, when we talk to you next whether we're making progress or not against these pillars, and we'll be very transparent about it.

Operator

Perfect. Thank you very much, James. Can you provide an update on your M&A progress?

James McCarthy
Acting CEO, Novacyt

Yeah. Sorry, I just pre-answered that maybe a little bit, but I think, Look, I've tried to show you know, the real examples where we've partnered with, outside firms, right? In, in terms of the thing and rather than going all over it again in terms of the development of the workflow, et cetera. I mean, I can just assure you, we are looking at more strategic partnerships, which could really accelerate the journey of the business. Something that could give us a bit of a step change. That by its nature is hard. I think we're rightfully challenging ourselves to, you know, pick the right partner, right? I know people will say you're stacking your cash for a long time.

That's probably still a better outcome than spending it on the wrong thing because you kind of get one go at this. I think I also mentioned valuations, have come back to be fair. In the last six to nine months, valuations are more reasonable, so I think we've got a more level playing field. Again, look, we're working very hard in that area, and hopefully I'll have more progress to share with you through the course of the year.

Operator

Great. Thank you. Thank you very much. Just turning to the next one. Are any further cost-cutting measures planned?

James McCarthy
Acting CEO, Novacyt

Shall I? Yeah.

Steve Gibson
Group Finance Director, Novacyt

Sure.

James McCarthy
Acting CEO, Novacyt

I'll leave this to you.

Steve Gibson
Group Finance Director, Novacyt

Perfect. I think, you know, fundamentally as a business, we'll always continue to review the cost base of our business and where it is appropriate, we'll take cost out of the business. If you're asking in terms of will there be another large scale restructuring program like we saw in 2022, in the immediate near term, the answer is no.

Operator

Perfect. Thank you very much for that, Steve. When will you appoint a new CEO, and is it likely to be linked with M&A?

James McCarthy
Acting CEO, Novacyt

Yeah, look, I think just to recap for everybody, I'm the acting CEO at the moment. Look, I think that was a decision the Board took. You know, we changed the CEO last year. I think the board wanted to have, you know, some time to say, look, there are so many moving parts in the business, right? As we still come out of COVID, I don't need to repeat the kind of extent businesses like this have shifted. Look, the board felt I was the right person to lead this business through that transition until, you know, we can demonstrate we're on the right strategic journey, we can get ones on the board, and that's why it's an acting CEO. Look, I'm delighted to be doing the role.

I mean, I love the business. I think it's great potential, so I'm very pleased to be in this seat. Look, I also appreciate it's an acting role because of the uncertainty around the strategy. Look, there's no plans to change that for now. I mean, I'd love to think that if there was a, you know, permanent CEO, I'd be a good candidate for that, and I'd be considered, and I'd be very pleased to do the role. That's really kind of a matter for the board. As far as I'm concerned, I don't wake up every morning thinking, Oh, God, I'm only the acting CEO. Right? It's not something that troubles me. I think the business gets our full attention, and, look, we're very committed to making it a success.

Look, the sec ond part to the question, you know, is that linked to M&A? I mean, I don't think we're that clever. You never know with M&A what happens, but I mean, it's just not a consideration. M&A, you always like to think you pick up great talent. You can't really plan for it like that, so that's not really a primary consideration at the moment.

Operator

Perfect. Thank you very much. How realistic is your five-year revenue target of GBP 100 million?

James McCarthy
Acting CEO, Novacyt

I think, you know, the GBP 100 million was an aspirational plan for the business. You know, this business should be able to get to those levels, you know, if it can build, you know, a compelling financial portfolio. I mean, when I look at where we are at the moment, how we're trading in Q1, GBP 100 million is a long way off. Look, I know it was always a kind of a 5-year plan out there. I think it's still an ambition of the company, I, you know, I can't lay a road map out for you now about how we get to GBP 100 million. I think it's still, you know, we should have the ambition to be getting to that kind of size of business over that period of time.

Operator

Perfect. Thank you very much. Can you be specific about where you're focusing your R&D efforts?

James McCarthy
Acting CEO, Novacyt

Yeah, sure. I mean, we did an extensive piece of work, last year. Market research, which I think we shared some portions of that through the various updates. Look, we're focused on infectious diseases, gastro, insect borne, they were the kind of three major pillars, and also some work in transplantation. We're... I mentioned we're developing RUO multiplex assays. We're developing them in those spaces in the main. You know, we're using that research to guide our development efforts. Look, as we get forward in that development process, we will share with you the products. I don't want to get into specific product areas at this stage. We're still working on them, but we'll be able to share those to you. Look, we've been

We're remaining faithful to the strategies set out last year in terms of the target areas we're going after. That hasn't changed. We're just getting on and now developing products in those spaces. That's where the main R &D effort is going when it comes to reagents. When you look at instrumentations and workflow, as I think I mentioned, we need our instrumentations to continue evolving, become more, have more capability as the diagnostic industry moves to more multiplexing. Look, we're gonna continue working on things like extraction systems, sample handling. This is not a static market. You can't develop something based on requirements at the moment. You have to keep reaching forward and customers expect better and better outcomes.

We will continue to work on that workflow instrumentation piece as well.

Operator

Perfect. The next question here reads as follows: How is the IVDR and CTDA advancing for new products and how the AG-LFT self-test respectively?

James McCarthy
Acting CEO, Novacyt

Let me try and break that down. I think there's probably 3 questions in there. I mean, IVDR is, I mean, we've talked about it in the past, it's obviously well known in the industry, IVDR is a significant. Now it's a seismic shift for the diagnostics industry in terms of product development. Not only have development times gone from, let's say, around 6 months- 24 months, if you think of where does that extra time come from? At the moment, about half that 24 months is products have to go through now a third party, a notified body. As a diagnostics developer, you hand your products to a third party for validation.

Those third parties are, funnily enough, at capacity because as you can imagine, you know, there was a lot of people trying to get their products through IVDR. There's definitely a capacity issue in terms of notified bodies and a transparency issue. It's very hard to get a, you know, a detailed timeline for some of these. That uncertainty is not helpful. It's absolutely not helpful when you're trying to build launch plans and commercialization. That's why I think I mentioned we are using our RUO expertise to develop RUO versions of some of these, the next kind of levels of development.

Do some client work with that in the RUO space, try and make sure if you go down the IVDR route, you're pretty damn sure you're on a winner because it's a pretty expensive process to go down there and find 2 years later or this thing doesn't maybe have the market reach that you thought or you're struggling with clients. It definitely has raised the bar in terms of like the IVDR development pathways. CTDA has been predominantly a COVID testing requirement for the U.K. only. We've been very, very successful. We have, I think we have seven products approved, including Winterplex. I think the future of COVID-only tests is obviously very uncertain, right?

I mean, I think we would all assume that there's gonna be very few COVID testing going forward, which won't certainly how we're running our business. Just on CTDA also for the as I said, just U.K., our Winterplex product, which is a panel, it happens to have COVID in the panel, but it's a respiratory panel that also has to go through CTDA. To the extent that a product has still got that COVID left in it, as part of the panel has to be tested. I don't think CTDA is the issue for us going forward. I don't think there'll be a lot more and more developments forward for CTDA, it sounds really an IVDR issue going forward. I don't think we need to worry too much about CTDA.

The last point, the third part of that, the LFT self-test is the product we see marked, which is gonna go through CTDA. Look, there's a fair argument to say, Well, why bother? You know, COVID is over. Do you really need another self-test product approved in the U.K.? Look, our view at the moment is we've gone so far with that product, it would be a shame not to have it CTDA qualified. I think that's the journey we're going on. That in itself isn't a, you know, short process. Again, it's not always exactly clear how long it will take, but we certainly would like to take that through CTDA and see how we get on.

'Cause I think, you know, for the incremental efforts, having had the product, you know, CE marked for that incremental effort, I think it's worth it to have another U.K. self-test that we could use, right? In the event that demand came back. That's our current thinking Alex. Okay.

Operator

Perfect. Thank you very much, James. Do you plan to replace Edwin Snape with a new non-exec?

James McCarthy
Acting CEO, Novacyt

Well, that's probably more a question for my chairman than me, but I'll be brazen as to give you an answer anyway. Look, first of all, I'd like to just add my thanks to what I think James said publicly at the time for Ed's service to Novacyt. Just I think it was outstanding. I mean, I think he'd seen the business probably, if not the longest serving director, he must be close. Certainly a long history with the business and, you know, great supporter of the business. I think, you know, at the moment, I think there's five directors. I think we'd always look for talent, right? It's not just, you know, is it a replace Ed, it's more a question of what does the business need going forward.

I think if James Wakefield was here, he would probably echo that. You know, we will always look for talent, always try and keep the board refreshed. This thing doesn't happen obviously quickly, right? This is something that will happen in the background.

Operator

Perfect. Thank you very much. Can you give us an update on how the business is performing in terms of geographic sales?

James McCarthy
Acting CEO, Novacyt

Steve? Yeah.

Steve Gibson
Group Finance Director, Novacyt

Yeah. I can take this one. I think I covered it earlier in the presentation. Let me just go over it again. In terms of 2022, the U.K. region accounted for around 50% of our sales, and that's where we have the most boots on the ground. It's not a surprise there. In the Americas region and Europe, excluding the U.K., both of those regions generated around 20% of our global turnover, the balance was from Asia-Pacific, Middle East and Africa. When you look at our Q1 sales for 2023, the total of about GBP 1.7 million, you know, it's broadly a similar geographic split as well. It continues the trend of 2022.

Operator

Perfect. Thank you very much, Steve. Perhaps time for maybe one final question? Can you provide an update on the situation with the DHSC?

James McCarthy
Acting CEO, Novacyt

Sure. I mean, look, I will always caveat this obviously is very tricky in terms of disclosure, right? I'm very limited on what I can say about a live legal case, which is what it now is. Look, we have shared, I think, everything with the market that we can. We try and keep you up to date on all the milestones around the case. I mean, as a quick recap, it became a legal claim in April 2022. We now, I think we updated you on this. We have a date for the court case, which is June 2024, which is about little over a year away. We've got a court date booked, that's really the date we're working towards.

look, I think I would say to everybody, we will still work to resolve the case any way we can in advance of the court case. I think both parties are still obliged to do that, and we're certainly willing and, you know, keen to try and come to a settlement if we could in advance. I think it's also important to know it doesn't really have a major impact on the day-to-day running of the business, right? This isn't a major draw on our resources, it's not a distraction from the business in an operating sense, we can pretty much just get on with our business, run our business, continue to invest. I think that's important from an investor's point of view. This is not dragging us down.

Look, it's always unsatisfactory, I think, the answers to DHSC, but I think you just have to appreciate a case like this is not something you can really just disclose anything in public, so beyond what I've just said. If there's any changes along the way, of course, you know, we update you as we always do. Any material changes along the way, we'll update you as we can. Okay?

Operator

James, Steve, thank you very much for that. I think you've actually addressed all of those questions you can from investors. Of course, the company will review all the questions submitted today and will publish their responses on the Investor Meet Company company platform. Just before redirecting investors, provide you with their feedback, which I know is particularly important to you both. James, could I just ask you for a few closing comments?

James McCarthy
Acting CEO, Novacyt

I think the only comment is to thank people for participating in the call. Thank you for shareholders for sticking with us. This has not been an easy ride by any stretch of the imagination. It's been incredibly volatile and a very difficult time. Look, I hope we're starting to lay out the forward direction. I think there's some really good strengths from which the business can build and sort of proven track record of developing products which we believe we can carry forward. We're well-funded, so we can support ourselves. I think we're in a market where there are actually more opportunities to invest. I think we're in a good place as we go forward. We have to prove it. We know that.

You know, we can come back and be very transparent with you in terms of how the business is performing as we move forward. Again, just to thank everybody for their participation today.

Operator

James, Steve, thanks once again for updating investors today. Could I please ask investors not to close this session, as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This will only take a few moments to complete, but I'm sure it will be greatly valued by the company. On behalf of the management team of Novacyt, we'd like to thank you for attending today's presentation, and good afternoon to you all.

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