Genincode (LSE:GENI) — Full year results briefing

0:01 Good afternoon, and welcome to the GENINCODE PLC 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 and 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 received from the meeting itself. However, the company can review all the questions submitted today and publish responses where it is appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Matthew Wall, CEO. Good afternoon to you, sir. Good afternoon, Alessandro, and good afternoon, everyone. Welcome to the 2023 final results and business update. I'm here at the Cavendish Broker offices in the center of London with Paul, our CFO.

0:47 And we're gonna walk through the results presentation from 2023.

0:52 I decided that it'd be worthwhile moving with a little bit of pace. We've got a lot to cover. And for those who've had chance to read yesterday's r and s, there's quite a bit to get through. So I'm gonna move a little bit quick quicker through today's presentation so that towards the end, do we have a bit more time for q and a? But in in any event, we'll cover off the the headlines and and the key points. So moving on. I'll also move through some of these slides a little bit faster than I would normally. But just as a a headline, we are a predictive genetics bioinformatics company. We have a high amount of structured algorithms in the background around the way we calculate and risk score cardiovascular disease, and we're now obviously taking our products to market in Europe, The UK, and The US. And the rest of this presentation brings everyone up to speed as to where we are in that program.

1:51 So I'm now going to move to slide five. This is a summary of what was presented yesterday in the r and s, but important that we we start here, and then we'll progress into what the the outlook over the rest of the year and beyond looks like. So year on year revenues are up significantly, 2,200,000, mainly in the growth from The UK and Europe. So good years from both of those regions. We also, last year, started our early access programs in The US for FH, that's lipid ENCODE, and cardio ENCODE as well. So both of those products now starting to come on stream in The US. The de novo submission to the FDA, well, we went we went originally with a five ten k. The FDA asked us to move across from the five ten k to de novo.

2:38 And, importantly, that puts us at the forefront of change in this area. This is a new regulatory class, and I'm pleased to say that we're making good progress with them as well. I'll come back to that in more detail as we go through. NHS also clinically adopted lipid encode in the North Of England, and that's now starting to expand. We'll touch on that. Germany too, we started clinical adoption of Lipid Encode there. So our first sales coming through there too. Good growth in Spain, as I mentioned. We finished the year on 2,500,000 of cash. Good investment in preparation for starting up sales in The US, and then we finished the year and started with a secondary placing. The intention of the company is to raise what it needs, you know, as it requires it, but at the same time to make significant growth on the back of that investment we raise.

3:28 I'm pleased to say that the first sales has now started in The US market. So moving from early access, we're into commercial programs. I've just cited a few. We'll look at a few more. But importantly, they're big, bigger groups, so I've mentioned them. You'll see in a moment some of the other groups that we're starting to work with as well. Also, big publications, so the American Journal of Preventive Cardiology. Kaiser presented their papers to that, and and we'll talk talk about the the importance of that publication for us as well. We received patent granting or notice of allowance as it's called for cardio encode. We also received nice approval for our new ovarian cancer risk assessment test. That's the ROCA test. So very pleased about that. And, also, we've got some early licenses coming through from Switzerland and Austria.

4:16 And so far year to date, we're 37% up on the same time last year. So, again, strengthening the growth position of the company as we move forward. Okay. Next slide is a summary of where we are on a product basis. Not a lot of difference here in terms of the rollout, things moving. We've added now Roku into this, so there's now a fifth stream of revenue starting. So we've not only got the the international expansion, but also now an additional product in the portfolio. So I've added that in. I won't go through this, but this is the process that we well, I won't go through it in detail, but this is the process by which we collect samples, transport them through to the lab. They go through molecular processing. That's the identification of the DNA and the variants within the DNA of the individual.

5:04 And from that, we then risk score and provide the results online to the physician. It's worthwhile saying that the systems that we have to do this are significant. They're global systems. They're harmonized. So what we do in the in Europe, in The UK, and The US, it's harmonized. That's important from the point of view of risk scoring and AI. The way we we produce those reports is done consistently. And it also means that as we move forward in polygenics and multiple gene analysis, we have a system that is very competitive in this space. So very pleased, and it's taken a lot of time over the last ten to fifteen years for those of you who are familiar with the company as it's grown to put this system in place. The US market, it's still incredibly significant for us, and this is where I I'm certainly spending most of my time and effort. So around eighty six million suffering with cardiovascular disease.

6:00 It accounts for the main area of mortality, certainly the biggest area of cost as well, not only in terms of health care spend, but also in terms of impact to the economy. And it's growing, and it's significant. There was a Lancet paper, I think, was released just in the last week or two, again, showing that cardiovascular disease is globally the biggest killer on Earth. And at the same time, even during the COVID years, it was higher than COVID. So it gives some indication as to to what we're dealing with in terms of the importance of recognizing genetics in prediction of cardiovascular disease. Summary of The US, and then I'll I'll skip through some of the other areas. We've we've started the commercial onboarding program, and I'll go through a bit more detail of that in a moment.

6:45 The core products for The US are lipid encode, which has reimbursement, and hence, we're leading with that, and that will be where most of the revenues come from for this year in The US. Cardio encode, a little bit behind it in terms of reimbursement, but again, moving quite quickly. Our first revenues have now started in The US. And again, for those of you who are familiar, we set up last year the regulatory pieces around the laboratory in in Irvine and also our de novo submission for Cardio ENCODE through the FDA. Again, just to to reiterate, good progress with the FDA. There's been a lot of work they've undertaken recently with Kaiser around information and access to the real world data that Kaiser have. Again, for those of you who are familiar with what we're doing, we've worked CARDINCODE over fourteen years. We've followed just over 60,000 patients.

7:35 So this is a population based study. What that study goes to show is the importance of genetics in risk assessment for cardiovascular disease. We'll touch on that in a moment again. Reimbursement, we now are coding. We've agreed pricing. Still a little bit of work on the pricing, but it's it's agreed at a price point that we think is increasingly getting right and fair. I'm still in discussions, but it's it's pretty much agreed, and and the importance of that is reimbursement, which would then be covered by Medicare. Reimbursement reimbursement, for those of you who are not familiar with this, is an important piece of establishing a revenue base in The US and a value, which is from a both a Medicare and a private insurance coverage perspective, a cornerstone that we we use for driving the value as we move forward.

8:25 And the other piece that's linked to that is a MolDX submission, and that's in preparation. But once we've agreed the final pricing, we'll submit that. That will be probably later this year, the MaldiX piece. Commercial operations, in terms of that, it's mainly around meeting with the key opinion leaders, educating, advising them, sharing with them the information and the the new data that we now have that's begun to start being published, and working with them to integrate our technology and products with their health care systems. Also, at the same time, commercial payer discussions, this is with the insurance companies who provide the health coverage for patients in The US health care system. And then finally, the publications have started, and there'll be a few more of these coming in the next, probably next few months. We've got Kaiser presenting here in London at the annual ESC conference. They've got an oral presentation, and I'll talk through now just a little bit of background in a moment on some of those publications that are coming.

9:25 They're the core partners we work with. So Indiana, Kaiser, MedStar, and New York Presbyterian. They've been at the forefront of us leading with clinical validation, clinical utility around the products as we move them into The US market. And this is the slide I showed about six months ago around the early access program. And at that time, most of these groups were colored white. They're now increasingly becoming yellow. Hopefully, that's a little bit easier to see, but the yellow ones are either onboarding or in the vast majority of cases starting to now order testing from us. So people like Indiana, Johns Hopkins, MedStar, Atrium, UT Southwestern, u c UCI Health on the West Coast in San Diego have all started to order, more recently, Emery.

10:16 And who else is in Saint Elizabeth? They're just onboarding at the moment. My intention our intention as a company is to drive the further growth and implementation of the products through these health care systems. They each sit in communities at a state based level, so that will cascade into that broader community coverage. And then on top of that, we'll also be looking at executive health and concierge medicine as well where they tend to pay a bit of a higher price for the products we take into market. So the commercial program has started in The US. This is a little bit of background on the publication that was made about six to eight weeks ago, a very important publication for us and also for for the health care industry. It's the first major population study which shows the importance of polygenic risk scores for identification prediction of heart disease. And it showed that Cardio Encode score, that's our product which we talked about, it's recently received patent approval, is independent of other risk measures, clinical risk measures. That means in its own right, it's an adjunct to clinical risk assessment.

11:24 It was consistent across male and female individual, consistent in terms of its application to both male and female, and also across ethnicities as well. It allows the risk stratification of individuals in the population. That's vital. So it starts then to, on a genetic basis, identify those individuals who are at most risk of heart disease, and also will, by doing that, those who are most likely and and and perhaps should be receiving statin and onboarding of therapy. And and back to the independent point, it works well and in and alongside traditional clinical risk factors. So the polygenic risk score, what it's going to be and it's starting to become, and there's still a lot of education required when we're talking with the physicians, it will become, an important it will move the needle in cardiovascular disease so that on a lifetime risk basis, individuals become aware of their polygenic risk for coronary artery disease. It's somewhat similar to the same process that in the last ten to fifteen years has been adopted for BRCA and Lynch syndrome, where the genetic test gives identifies the risk of the woman in the case of BRCA for breast and ovarian cancer.

12:40 And then at a point in the future, the likelihood is based on that risk, she may or may not have a future issue with breast or ovarian or the need for risk reducing surgery. In the same way with coronary artery disease, it gives an indication of the lifetime risk of that individual, especially for those who have a high polygenic risk score. So it's a necessary step, a necessary move to improve the standard of care for cardiovascular disease. The market hasn't changed, it's a significant market based on we've actually narrowed it to those who we can see at the moment will need it most and they fall into what we call low risk or intermediate risk of cardiovascular disease. And they're measured in terms of low risk or intermediate risk on their clinical risk assessment, not on their genetic risk.

13:26 As we bring the genetics alongside that, a high number of those low risk and intermediate individuals who were then found to be at high genetic risk will be reclassified into a much a much more focused therapy and treatment. So at the moment, within that twenty one million, there are individuals who have a high genetic risk, but we don't see them. We're not aware of where they are. So when we asked physicians about the use of the technology moving forward, they said they would, around eight and a half million of those patients, they would prescribe if there were a product available that could identify the genetic risk. So these market figures haven't changed. In fact, we we recognize at the moment that they're likely to be increasing simply because physicians are becoming more aware of the value and the importance of polygenic risk.

14:17 The pricing I I mentioned a little earlier, it's going to end up somewhere in the region of 500 to $760. The CMS have proposed 500. We did discuss last year, and we had a approval at that point from them that it was near 760. They've come back and asked for a slightly reduced figure, so I'm still finalizing that with them. But we expect it to be agreed between those prices, both of which will be, I think, reasonable for us in terms of rollout as we move the product forward. They're both attractive in terms of margin and value as we as we drive volume through The US market. And the reason why it, again, is getting more exciting, there was also a significant statement by the American Heart Association about polygenic risks. So this was published last year, and the importance was that they were now citing polygenic risk should be starting to be taken into consideration alongside clinical risk parameters.

15:12 When the standard of care changes, we're at the forefront of that in terms of our product positioning. There are very few, if any, at the moment given our FDA de novo position. There is no one in this space. We will be the first to market with a clinically approved, adoptable, regulatory approved product in The US. And once the guidelines change to incorporate polygenic risk, that's a strong competitive position for us. And this is a summary. I I actually it seems a fairly busy slide. So what I did was on the the bottom left hand corner was made it a little easier to interpret. But you have the timeline for regulatory at the top, and then below that, the box of the reimbursement pathway for cardio. But in summary, we're well advanced now with the pricing as I've just discussed with the CMS.

16:00 Reimbursement, well, once we've just finalized the pricing, we'll submit our MolDX submission. But at the moment, we have a cash pay arrangement out of pocket. On the regulatory side, you know about the FDA approval and the fact that we're in the de novo position. And then in the meantime, we're selling our lab developed tests through through the process into The US. Evidence base, as I mentioned, is very strong. And I think as a group, I don't think anybody's putting out the level of population based data together with the strength of evidence that we are and guidelines. As I said, they're starting to change the statement by the American Heart Association very much in our favor. So some done, some on the way in terms of Amber, and I've just summarized them in that way. I think it's a little easier for to pick that up from this slide. Otherwise, it feels a little busy.

16:49 So moving across to lipid encode. This is the product that will generate most of our revenue this year, and we'll see growth in The US coming from this. And the reason, partly because it it's reimbursed. It's got good pricing. It's all already established as a test in The US market and is escalating in terms of importance. So the CDC have lifted this to a tier one status. There are only three genetic products at a tier one status. BRCA, which you'll be familiar with for women's breast and ovarian cancer, Lynch syndrome for, again, for oncology, and then finally, what's called familial hypercholesterolemia FH, and that's what lipid encode analyzes and presents back. So that is the accelerated onset of atherosclerosis is what FH is. It's an inability to metabolize cholesterol effectively, which means it circulates at a higher level in the blood, giving rise to blocking, clogging, buildup of plaque in the arteries. So not not a, not a good thing and an accelerated onset of of heart disease.

17:51 So that's that's where we come in. We've got globally the leading test in this space. It's not only cost effective. It's a very broad test, and we're at the forefront of variant classification. We do a lot of testing in Europe and increasingly here in The UK as I walk through in a moment, and now we're starting to see it adopted in The US. Smaller market than cardio encode, but a small and growing market as people become more aware of the importance not only of what we call the monogenic risk, which is this one and a half million, but increasingly the polygenic risk in the population as well. And, again, polygenic risk is only becoming more aware because we now have technology that can measure this and see those individuals at higher risk. So an important step for us not only to be able to command this market, but to see the market growing as well.

18:42 Much higher in terms of reimbursement here versus cardio encode. So it's on average about $1,200. They they price for a FH test. Now as the volume grows, I expect to see that reduce some, but still it's a significant value opportunity for us as a company. And if we can lay claim to not only the strongest product in the space, but then start to take market share, then that that's where we want to be. And it's very much the same process here in the in The UK. The other piece that's becoming a bigger feature of what we do is the what we call investigation and prior authorization. So when a patient is referred for testing, we have to check their insurance health care background, make sure that they've got coverage in place. So that means we're working with the likes of Aetna, Blue Cross Blue Shield, UnitedHealthcare, Medicare, and so on. These are the biggest providers of health care in The US.

19:37 And we work with them in the initial stages because they won't have seen GENINCODE before in what's called out of network. As we build a profile with them and we do more testing under their umbrella, then we move to what we call in network, and that then requires further negotiation with them around volume benefits and things like that. Well, I'm pleased to say we're into that process. Not big numbers, but significant for us at the start. We started this process, it's a very, again, complex but very valuable process as we drive insurance claims through The US market. Again, much easier in summary here for regulatory because the regulatory position is in place, so it's more around clinical adoption and growth. And as you can see in the bottom left hand corner there, pricings there, reimbursement, regulatory, evidence base growing too. We do most testing globally, I think, in this area, and guidelines are in our favor too. So, hopefully, now a strong following wind as we start to grow the product through the The US market.

20:38 Moving over to The UK, this is the the NHS summary. So for those of you who followed the company last year, we introduced the FH lipid and code test to the North Of England. I'm pleased to say that that's grown. So from starting in Newcastle, it's moved then down through to Leeds and Sheffield. So North Of England is very much the North Of England. I'm also pleased to say it's moving through the Northwest. We have discussions also going on a little bit in The Midlands and also with UCL partner here in London. Slower and for lots of reasons with the NHS, but nevertheless, what we have is a product that is more cost effective than is currently delivered in the NHS, much more comprehensive and effective globally, like I've said. And our turnaround time is ten days, twelve days versus three, four, five, six months sometimes with the NHS. So we have a significantly, superior product in all respects, so there's no reason why it shouldn't be taken up swiftly.

21:38 The other important piece is that it will allow the NHS to focus on other areas of priority which they are effective and can deliver at. But in this instance, this happens to be one where we're we have a strong hand and it's it should be not only cost effective for the NHS, but adding much greater clinical value when it's fully adopted. There are 15, what we call HSN's health in information networks in the in the NHS England. They are in their own right. Each one of them has a a value piece that they should bring with them, and our intention is to take them one by one. We started well in the North Of England, and we look forward to bolting on the others.

22:23 We'll give an update later in this year, but we do expect to see others coming in the short, medium term. Europe, good growth in in 2023, and it's continued into 2024 mainly through and just to be clear, the Spanish market is much smaller than The UK and obviously The US market. But nevertheless, it's had a good growth in 2023. It's continued into 2024, both collaboratively. So collaboration is growing on the Spanish side. Also, Italy has come on stream stronger. And then finally, German who joined the group, we saw good growth beginning with growth last year, that's continued into 2024. A couple of slides on ROCA. So ROCA is our new test area.

23:09 Different from cardiovascular, this is risk of ovarian cancer algorithm. We liked it as a group because it was a simple digital algorithm in terms of adoption. And importantly, over the last ten years, in the early years, it didn't have as much evidence base. But in the past few years, the evidence base has been significant for this product. It now leads the way in terms of evidence

23:35 on a global basis, and evidence, together with the positioning of what we're doing with ROCA, was put to to NICE twelve, eighteen months ago. They reviewed the data, and I'll just draw your attention to that. The evidence at the in the final box there related to accuracy and staging. Importantly, this product not only is effective at surveillance for women at risk of ovarian cancer, but is incredibly cost effective as well. So it lends itself to adoption with the NHS. So we're very pleased about it. We received a nice approval. And then, commercially, we're now starting we're in discussions with four to six, four, I would say, earnest in the NHS around implementation. We're also thinking about specialist commissioning, and that would lend itself to being adopted in the NHS app.

24:25 And then more recently, just after the announcement, Switzerland and Austria came through with interest on a license agreement, which we've now signed with them. So it's moving with a a faster pace now on a commercial basis too. So we're very pleased with progress for Roku. Okay. I'll hand over to Paul who gives an update on the finances. Thanks, Matthew. So just to reiterate, this is the consolidated group financials. The full financials are at the back of the pack in their appendices. This is just a snapshot of the operations. We have the Spanish operations. We have The UK operations, and we have The US operations. The UK now includes Acodia, which we acquired, as you all know, at the back end of twenty twenty two. So full year revenues up £800,000 to 2,200,000 revenues. About half of that 800,000 growth is increase of 26% revenues in Spain.

25:20 Spain, as you know, has enjoyed continued growth of between 2025% per annum, and it looks like they'll be doing the same in 2024 as well. So a good backbone to the business. UK revenue has grown tenfold from about 36,000 to 360,000 in a year. And that's mainly because we got the NHS contract, as Matthew mentioned, in May 23, and that's generating between 50 and £60,000 revenue per month. So this year, we're getting the full benefit. And if we get another region on board as well, the the revenue would be even even higher. So good solid growth in the in The UK. And we're now starting to see The US revenues coming in as well. So that'll contribute to a strong 2024 finish for us too.

26:14 Product wise, Lipid Encode continues to be the biggest seller. So half of our revenue is generated by Lipid Encode. Remember that all the sales from The UK is Lipid Encode as well. So that's one of the major contributors to, that product. And the rest is Southern Code, which is, represents about £500,000 revenue from the Spanish office. Margins increased, from 44% to 47%. Again, that's mainly due to the, geographic mix. As I've always mentioned, Spain continues to be the, you know, the toughest region of our our target markets, between 4550% margins. UK tends to be around fifty fifty to 60%. So that blend of UK revenues has helped boost that margins to 47%.

27:02 And when The US, revenues kick in in earnest, that average should increase to 55, 60 and beyond going forward. So I'd be expecting 2024 to be around 55% mark. So much healthier, even more so this year.

27:22 Losses increased from 5.9 to 7.2. That's mainly due to the headcount increase. And as we mentioned at the insurance, we've geared up the lab staff and the sales staff in anticipation of The US commercialization launch. So that's as expected. And then cash balance is at the bottom. We ended the year at 2,500,000. That's better than expected. We continue to drive the cash controllers as nicely as possible. And we've got a pretty low, fixed cost base. So we try and, manage that cash as best we can and and only gear up the overheads, as we are, moving towards commercialization, and not have, staff sitting on the fence or other overheads, which we don't need to spend at that time. So around 600,000 of that 2,500,000 related to the fundraise, which we completed in January.

28:22 So, 4,000,000 fundraise in January. So we're we're we're at about 4,000,000 at the end of March twenty four. Run rate is about 400,000 a month. So continue to look after the cash, very nicely and a strong position there. Wonderful. Thanks, Paul. And and, yeah, I mean, just just so that everyone's aware, we're we're particularly keen on making sure we we keep a tight rein on all that. And with the if you look at the the guidance at the moment for this year, they're estimating something in the order of four with a revenue margin perhaps in the order of two, which if you take that, you're reducing fixed cost of six, it it brings us significantly down in terms of expected losses at the end of the year. And that is the model that we're moving. We're moving to a breakeven based target model, drive the top line growth of the company, keep the revenue the margins of the company improving as we bring in the the improving mix certainly from The US side and move the company into a a different space and really do differentiate what we're doing amongst you know, in the sector. It's particularly keen to we're particularly keen to make sure we take advantage of our position from where we are.

29:34 Okay. So just to start to round up, I haven't put all of the the big milestones here. Most of we've just touched on, But the big ones, following the de novo process at the end of last year that moved us across from $5.10 k into de novo. Whilst there's still a month to run before, I would expect to be to to got confirmation from our friends at the FDA. It looks like it's gonna take them longer. We're looking at quarter three at the moment. We've had good earnest, strong, good discussions, progressive discussions, as I said, with them. So we're currently anticipating regulatory approval around quarter three.

30:11 We've also got updates at the annual conference, as I mentioned, around Cardiom Code from Kaiser Permanente. We also expect a number of updates from the NHS a little bit later this year, as I mentioned, around maybe expansion, Roku, and so on, and also the finalization of the pricing for Cardium Code. So that's some of the headlines. The other thing that's happening is there's an increasing number of collaborations below that, whether Indiana Kaiser now complemented by Atrium and UC Irvine on the West Coast.

30:41 So just to finalize, we expect this year to see significant year on year revenue growth with the expansion of lipid encode and the beginning of cardio encode in The US. We expect to see approval from the FDA, expansion in the NHS and in Germany and in The EU, and then based on the NICE guideline approval of ROCA expansion on ROCA two. So the engine room in terms of revenue channels is moving quickly now. And and so it should. We're very this is part of what we plan to do, and it's starting now to get traction. So we're pleased about that, whilst at the same time, keeping the cost base tight and turning the company into a very attractive opportunity for investment. So that's where we are. I'll pause there. That's the end of the presentation, and we'll move across to q and a.

31:28 Paul, have you got some questions? Questions. Some of them were presubmitted, and and we've got a couple of extra ones that come up during the presentation. So please feel free to post any questions that you've got. We've got a bit of time to go through them in a in a bit more detail. So I'll read the questions out, one of us will answer them. So the first question is, in 2016, the FDA warned women that early detection tests for ovarian cancer, including the ROCA test, marketed in The USA by APCODE, were unreliable. It further said that it is not aware of valid scientific data supporting the use of A test for ovarian cancer risk assessment in asymptomatic women. And is the VOCA test reliable? If so, why do you believe that it is, and why doesn't the FDA?

32:20 Well, I mean, that's quite some time ago. Was that two thousand sixteen, fifteen yeah. Well, it will it bring I would imagine it was back in 2015 when they even looked at the data. But in any event, 2016, some time ago, and it was well before the latest data that we've got from the ALDO study. So the ALDO study was a milestone. The UK Fox study was the one before that. Both of them indicating that ALDO had an ability to see, survey, and see women at risk, But the ALDO study showing significantly that those women who'd had a BRCA, so genetic were at genetic risk for, breast or ovarian cancer, that the evidence from ALDO shows that by surveying them using the RoCA test gives an early insight, an early awareness of those women at increasing risk.

33:08 I mean, I won't go into too much detail here, but it's the c a one two five antigen, the antigen that we look at, and the algorithms that we use for this are now well proven, and that was what was submitted as part of the Aldo, or that's the Aldo program that was undertaken here in The UK. Was submitted to NICE. Now this isn't 2016. It's just it's more recently. And just so whoever the who asked the question on that, the reason why we as a board liked it was for the very reason that we had a continuity of evidence base reaching back to 2012 onwards, including perhaps the early evidence that maybe wasn't strong enough in The US, but was now much stronger. So when we acquired the company, it was for the very reason that I I, for one, felt that the combination of improving evidence base together with a very attractive health care economics attached to it. So this is for PARP inhibitors and the avoidance of or the early indication that we need to onboard or or get the woman into the right place for treatment, that the evidence was particularly strong. And that's why so I don't need this is not a company answer. This is a NICE answer, why NICE gave it a recommendation and why it's been taken up now by the NHS.

34:20 So, hopefully, that answers that question. Next question. Your final results say that given the challenging markets, we will grow revenues whilst maintaining a tight control over operational costs to target breakeven straight profit position over the medium term. We expect to de rescale business model whilst delivering strong growth in our core markets. Are you saying that you do not anticipate asking shareholders for additional funds?

34:48 Well, having can say those things, how we jump to the conclusion of then no funds is one thing, but let's let's just tackle it in terms of where we are. I I am always, and I think, you know, that would surprise me if if others would think different, but we're reluctant to take any capital unless we can see it's significantly adding value. So as you can see from the way we're moving, we're going to continue to generate improving revenues, margins, keep the cost base tight, and look for less and less reliance certainly on the capital markets. That's not something we want to do. At the same time, when we when we set out to build a company, we always said that we need sensible amounts of investment to make sure we can deliver on what we're building. So that that's, if you like, leaves the door ajar.

35:33 But it isn't a black and white answer. So we're also considering, and I can tell you this, that there are also collaborative potential opportunities that we're thinking about. Perhaps nondilutive capital as well is something that's on my mind. So there's number of other avenues. It's not all on another raise or something along those lines. And to be perfectly honest, in any event, when it does come to, if it does come to, that based on what we're doing and what we're pursuing, It it won't be a large figure because as you can see from the numbers, we're improving and strengthening as we go. And if we do find another channel, it will be what I would say in the current market or certainly for the technology we have and where we are, a very light touch in terms of a capital raise. So it's not only the only game in town, and there are other things going on.

36:22 And perhaps as we move forward over the next few months, we'll give a bit more color over that. But for now, yeah, there's no intent to to look to raise. We're doing pretty well. I'm very pleased about the growth we've seen so far year to date. That's not top of the priorities for us for our focus at the moment.

36:39 Next question. Have you considered making an offer for Oxford Biodynamics? They appear to have a terrific product but are struggling to make headway. I haven't I have I haven't looked at that. I know I know them a little bit, but I don't know them. I haven't looked in any we haven't looked at any detail or anything like that, so I can't I wouldn't be right. I don't think it'll appropriate to comment on that. But I I what I would say is yeah. I mean, if there any in the future, if as we grow as a company, if things that are naturally complementary and add value to what we're doing and and, you know, sensibly positioned, then then we'll look at them. But I don't know any detail behind

37:16 that, so maybe it's just a a punt from someone out there. Who knows?

37:22 Thanks. Next question is what has been the response from the NHS and the University Clinic Dresden regarding the implementation of lipid ENCODE? And can you please comment on your expansion plans here? Yeah. So both of them have grown since we introduced them, and they've only been really growing for the best part of six, eight months now in the in the in The UK and also roughly speaking in Germany. I can tell you that as I said just in the presentation, and I don't know when that question came in, we're already expanded somewhat in the North Of England through Newcastle, Leeds, and Sheffield. The other thing that we've done, just to to give further color to that, is we now have the system set up whereby we collect the samples for testing from the NHS, and we we get the reporting directly back into the physician who may who raised that.

38:13 So So it goes directly through our systems back to them providing the reporting. So it's a significantly advanced process that we've now adopted with them, and the feedback has been excellent. They've got a number of papers they're gonna be presenting at Heart UK in the next month, I think it is. So I I I mean, from the point of view of delivery, turnaround time, and like I said, cost effectiveness to the NHS, it's a big win win win. Three wins, I think. Thank you. Next question from David is what specific measures are being implemented to maintain tight control over operational costs while scaling up commercial programs?

38:52 So maybe I'll start that one, and Matthew can Yeah. Yeah. I mean, firstly, I expect overheads in 2024 to be around 10% lower, at least, compared to 2023. 2023 was always gonna be a little higher. We've got some relatively high one off costs. An example would be trial, study trial costs with, Indiana University, with Kaiser, with MedStar. Those were to contribute towards the high quality, de novo submission we made to the FDA. They are nonrepeatable. We haven't spent a penny on study trials this year. So they are nonrecoverable.

39:39 Secondly, Avasana costs. We've mentioned before our Avarsana, our US commercialization partner. We've always mentioned that the contract with them is flexible. They've done a great deal of work with us and have been a huge help. But at the moment, we have paused that work, while we work on, other aspects ourselves in house, so we can, scale up and scale down the amount of work with Evarsana, work to our to our own pace as such. So this year's our 2023 costs were about £900,000 lower than they were in 2022. And so far this year, they are zero. I think thirdly, probably things like, the lab capacities.

40:28 We could, we did anticipate scaling up the labs this year to scale up, according to demand for the for the tests in the future, but we know that we have at least twelve months capacity. So we're going to pause scaling up our lab lab capacity until our test demand increases, which is absolutely the right thing to do. Headcount increases, we are not going to increase headcount until we are a little bit nearer to an accelerated US commercialization launch. So we're we're just keeping an eye on costs overall and only gearing them up as and when the revenue pace dictates that to us. Anything I've missed there, Matthew? No. I think I mean, that's it. I mean, we we we've on that cost side, we're we're doing it in a very it does mean that we are very busy, and I'm spending a vast majority of my time focused on making sure we engage and grow The US.

41:26 And and we're obviously keeping headcount and resource recruitment to a level at which is commensurate with our growth. We've got to make sure, though, that we we grow in the right way, but it it isn't in any way an accelerated process whereby we are leading with resource investment. Now it's the other way around. We're leading with revenue delivery and lagging with that investment to some extent. So, no, I think it's I think that's pretty good summary, Paul. I think it's about right. Another question from David. Can you explain the strategic significance of launching cardio ENCODE pilots in Spain and share any results so far? I can tell you it's gone well. The extra Madura piece of it is is pretty advanced. There are eight main regions within Spain, and extra Madura is perhaps leading them. Andalusia and Catalonia are also following quickly, there's a couple of other regions coming.

42:20 Typically, what happens or what we expect to see happening is as it engages more so in Spain, they're a little bit like a domino effect. The other regions follow. They tend to be joined in that way in the way that they operate. So, no, it's gone well. It's engaging. It's taken time. The budgets are obviously still for for them as a nation and for health care is still obviously challenging. But we're pleased with progress because it's becoming now a little bit like The US, recognize that polygenic risk assessment is key not only in The US, but also in Spain. Unless there's any other final questions, that's about it. So maybe we can hand that back over to Alessandro. Perfect. Matthew, Paul, thank you very much for answering those questions from investors. And of course, company can review all the questions submitted today, and we'll publish those responses on the Investor Meet company platform.

43:09 But just before redirecting investors to provide you with their feedback, which I is particularly important to you both, Matthew, could I just ask you for a few closing comments? Thanks, Alessandro, and thanks everyone for for attending. We are if there are any other questions or if anyone has any further thoughts, don't hesitate to to reach out. We're conscious that we don't always see everybody face to face, and this is quite a a good opportunity for people to to see at least and get some insight in more detail than perhaps normally. So but, no, if you've got any further comments or questions, please reach out to us. But in the meantime, thank you for your, attendance at today's call. Perfect. Matthew, Paul, thank you once again for updating investors today. Could I please ask investors not to close this session as you now be automatically redirected? Provide your feedback in order the management team can better understand your views and expectations.

44:00 This will then take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of GENINCODE PLC, we'd like to thank you for attending today's presentation, and good afternoon to you all.