Genincode (LSE:GENI) — Interim results presentation

0:02 Good afternoon, ladies and gentlemen, and welcome to the GENINCODE Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Simply type in your questions at any time and press send. The company may not be in a position to answer every question received during the meeting itself. However, the company can review your questions submitted today, and we'll publish those responses where it's appropriate to do so. Before we begin, we'd like to submit the following poll. And if you'd be so kind to give that your attention, I'm sure the company would be most grateful. I'd now like to hand over to CEO, Matthew

0:33 Walls. Good afternoon. Good afternoon, Mark, and good afternoon, everyone online. Thanks for attending today. Hopefully, you can see the presentation of the interim results. So we've been here today, myself and Paul Fulgi, who's with me, CFO, presenting to investors in in the city. It's, pouring down outside, so pleased to be inside and not dashing from meeting to meeting. Anyway, we'll skip through the first few slides, but, just to give a quick summary as we go. We'll hit on most of the points that we typically report on, and then we'll finish up on summary and outlook. Board, no changes. Again, I won't go spend too much time on on the GENICODE summary, but you you get a little bit of a summary as to where where we are in terms of background, how we formed as a company, intellectual property, the reason for why we're focused on cardiovascular disease.

1:30 And, really, the the essence of today is around the interim results that we're presenting. So I'm gonna walk through these, and we'll come back to some of the the headlines in a bit more detail. So sales, significant growth over the first half driven by UK and EU products. And that's mainly off the the NHS coming online and also stronger position in in The EU. Again, we'll touch on that a little bit later. We've started our launch program in The US, so very exciting about the progress we're making there. We now have 40 of the selected key institutions now onboarding. Again, we'll talk through this in a bit more detail as we go through the slide deck. We filed our five ten k, so this is for expansion of our cardio encode score in The US market. We also received coding for cardio encode as well.

2:20 And, again, that allows us to accelerate growth once we receive regulatory approval for cardio encode. I'm also pleased to say that I had presentations. These are public presentations with CMS for cardio ENCODE score in June and July, and they voted in favor of a payment of $760 a test. We're still waiting for the final publication of that, but I think very excited that that'll be the test price that we use for Medicare, Medicaid pricing going forward, and it will be part of the 2024 clinical lab fee schedule. It's also fair to say that the environment now is also changing for introduction of polygenic risk assessment in The US. Please say the American Heart Association is also now supporting the introduction of polygenic risk assessment.

3:09 It's an important step for us because we are a first in class product in this area. And, again, that will add further momentum and acceleration for scale up and growth as we move forward. We got clear certification we announced on that and also more recently cap accreditation. So our US laboratory is operating at what is the gold standard of operation with a cap accreditation. We also announced MedStar. MedStar, we're working with out of Washington, Maryland. They're one of the key groups who will be helping us underpin our MOLDX submission for reimbursement for cardio encode, which we expect to file later this year, possibly early quarter one. We presented at the, ESC, the European Society of Cardiology, a few weeks ago, and we'll touch on this again. Kaiser Permanente presented on an ab an abstract of the fifteen year data. It's very powerful data. Rarely do you see follow-up data over fifteen years, and it significantly moves on the use of polygenic risk assessment for cardiovascular disease. So we'll touch on that again in the slide deck as we go.

4:14 We received UCAS and ISO thirty four four eight five accreditation for the Hammersmith lab. That's servicing the expansion of the NHS work that we're now doing. And I think most people have seen we announced the NHS adoption of lipid and code in the North Of England a few months ago. So that started to come online in May. So a little bit of upside in growth in the first half, but we'll see that significantly contribute to the revenues in the second half of this year. We also we're collaborating in Germany too with University Clinic Dresden at Uniclinicum. Again, that that will also contribute to revenue growth in the second half. And, also, we're making good progress with our Extramadura Spanish collaboration where they're looking at primary prevention using cardio encode.

5:00 A few days ago, we received NICE confirmation that they have issued guidelines now including our ROCA test. So that's the acquisition, small acquisition that we made at last year. I'm very pleased about that because that now allows us to and if if you have chance to look at that, the guidance is significantly in support of ROCA being used for those women who choose not to have risk reducing surgery. So if for those who are familiar with it, when you have a BRCA test, if the woman is positive, the risk reducing surgery of removal of the ovaries is the the optimal risk reducing step, but removal of the ovaries is a significant surgical procedure. A lot of women will not want to undertake that, especially those in at a childbearing age. But nevertheless, we have as a result of that, we have a a test that allows them to be surveyed for those women who choose not to have risk reducing surgery.

5:53 EBITDA loss is up, but that's primarily on the basis of us preparing to launch in The US and also here a little bit in The UK. Cash reserves at 5,200,000. Strong, so we've managed to conserve our cash position well over the last couple of years. It was when we when we listed the company two years ago, we said about this time we would be looking to come back to the market. The markets have been difficult, but we will be looking to make a raise over the coming weeks and months. So that's something that we're moving towards as we speak and certainly from the discussions we've had today. I'll move forward to not touching on too much detail here on the the product summary. You can see that we're gradually turning those products lead products for The US, CardiEncode, Liberty Encode green, and we now obviously file the CardiEncode submission, five ten k submission with the FDA.

6:49 Again, a summary of the the way we operate, simple sample into the laboratory, extraction of DNA. We then go through our bioinformatics AI libraries that score that DNA variant position, and then we would provide the reporting online through our cloud based system, Sitab, to physicians. Again, market significant market for cardiovascular disease in The US and growing, and also major issues around mortality levels because rather than mortality and age levels increasing, they're gradually starting to decrease, which is a lot to do with lifestyle. But but, yeah, it's an important and growing issue in terms of The US. And here's a summary of the The US strategy, and this is where we are. So the early access programs at 40 are now onboarding.

7:40 A significant number we started at the end of the first quarter. It goes through a process of educating physicians on what the tests are in terms of genetic risk at a patient level. They then go through an early access program where they get to use the testing for free, and then we move into a commercial phase where they start to adopt it. So I'm pleased to say that a lot of those are now going through early access, and we're looking at, in the second half, our first revenues from The US. They're not only looking at Lipid Encode, which has got reimbursement, but also Cardio Encode. So in the short term, the revenue generation from Cardio Encode will not be by reimbursement, will be from out of pocket or self pay processes until we get reimbursement in place for Cardio Encode. As I mentioned, we've got cap clear. Five ten k has been submitted.

8:27 We received our PLA coding by the American Medical Association. And importantly, with the CMS, we've now received pricing for the cardio encode test. We're preparing our MolDX submission, that then gives us the clinical utility for cardioENCODE that will finish off and effectively then position us for reimbursement growth for cardioENCODE. Important to recognize another group who we've touched on previously, but a key part of us growing and scaling up is Cenogene. They're our revenue cycle manager. So in the next few weeks, we start to plug our invoicing processes into Cenogene, and they deal with all of the patient analysis of health care, payer insurance, whether they're being paid or reimbursed through Medicare, Medicaid, or whether it's self pay. It's a very complex process and used by the revenue cycle managers, effectively clearing houses who handle our invoicing and benefits investigation for us.

9:23 A key part of growing and scaling up what we do in The US market. So that's exciting as we bring them on stream. And it will also underpin, the the revenues in the between now and the end of the year as we start to bill for the first products coming through. Publications, touched on the, European Society of Cardiology, Kaiser, abstract, which was very well received, and we'll touch on that in a moment as I as I look at, I'll show you some of the the detail of that. We also have multiple publications now coming from, that Kaiser study, so there are likely to be three or four publications. But the main one will be filed with a high impact journal, likely either Jack, JAMA, or Circulation. The main publication is going in next week.

10:10 This is a summary of the key groups we're working within The US. We're either working with them now commercially or they're involved with us on the clinical evidence base and building Kaiser, for example, and Indiana dealing with on the calcium scoring and image analysis. But all of them are groups that we're now starting to move to commercially as we implement CARDINCODE and LIPINCODE in The US. And these are the first 40 or the 40 for primarily quarter one and '2 moving through into quarter three. We're run roughly running about 20 institutions a quarter, and I I think that will continue for the next twelve months and beyond from what we can see. We've tended to focus on the main core influencer institutions that, if you like, best in class, and that's been a really useful exercise because those individuals are the key physicians, influencers within cardiovascular, and the intention is by working with them that they then work within their network to then cascade that through. So it it's a key part for what we're doing, and so far, it seems to be working very well.

11:15 And this is what it looks like in detail. So it's quarter on quarter. So you can see perhaps those of you looking on smaller screens might not be able to see the detail here, but you have a quarter one summary of the institutions that we've now onboarded, quarter two, quarter three, and now as we move towards quarter ending, quarter three, and into quarter four. Like I say, we're looking at around about 20 per quarter. They go through what we call an engagement piece where we advise and educate them on the testing. They then go into the early access program where they get the testing free of charge, and then we go into the commercial adoption. And as I've just said, we're starting now to move into that commercial adoption. For the early groups that started in quarter one, those are starting to now move into the commercial adoption phase. We expect this to be a very high number of conversions, and the main reason is the evidence base we have and the strength of the products is a necessary part of risk assessment for cardiovascular disease. So whether it's our product or other products to come similar to us in the future, it will be a part or an increasing part of the standard of care for cardiovascular risk assessment.

12:19 And as a result of that, the the market opportunity is significant, both the total addressable market, but also the serviceable market that we can see for using our products.

12:31 So here's an extract from the abstract that was, submitted or or presented at the Amsterdam meeting, European Society of Cardiology. Just to say, if you can't see the detail of this, the the red bars are those individuals at high genetic risk. And in every classification, those individual at high genetic risk have a higher likelihood of heart attack or cardiovascular disease. So on the y axis, you have the rate of heart disease, heart attack, angina, or the events that we measured. And on the x axis, you have the the category in which they were then viewed. So in the top left bar chart, if you can see that, what we show is that individuals who have a poor lifestyle and a high genetic risk, by changing their lifestyle, they can reduce their risk of a heart attack by about half.

13:23 So it's a significant number. And the same then is applied across the other bar chart areas. So for smoking, you can see the escalation in risk associated with an individual who never smokes, used to smoke, or currently smokes with the highest bar, in other words, heart attack, being related to those with the highest genetic risk. So whether you're smoking, whether it's physical activity or Mediterranean diet, those those individuals with a higher genetic risk have the higher propensity to heart attack. So this is important because it it underpins the first major point, which is genetic and lifestyle factors are independently associated with coronary heart disease. What that also means is that because they are independently associated, genetics needs to be part of the risk assessment.

14:10 And, again, it's worthwhile saying that genetics represents half, fifty percent of the risk of a heart attack, whereas the individual clinical symptoms are much less in terms of parameter and and the value that they contribute to, coronary heart disease. As I've mentioned, you see a significantly lower rate by an individual who has a high genetic risk who follows lifestyle. And the key is to identify and focus those individuals who have a high genetic risk with therapy and with lifestyle change because in doing that, we reduce mortality. So what we also show in this paper in the abstract was that by focusing treatment on those individuals with the high genetic risk, you reduce the numbers needed to treat to avoid an event.

14:56 So the numbers needed to treat event calculation is a really important one in medicine, and this is part of the paper that will be submitted next week.

15:06 Like I say, it's rare that you see a fourteen year follow-up dataset, and we're very excited about the the publication that will come from this. And there's not only one. We'll also be making further publications in cholesterol lowering drugs. So identifying those individuals who buy their genetics should be taking statins, in the case of cholesterol lowering for statins, or antihypertensives who've been missed because their clinical risk did not identify them at high higher risk because of their genetics. Okay. Moving on. This is again, I've summarized this before, but just reiterate, this is the market size that we're moving to for cardio, intermediate risk, and low risk. There's around twenty one million individuals. And of those, around eight and a half million of those who are currently the physicians would prescribe if they had a test, genetic test, available to them, and that's what we're now bringing into The US market as we go through the process that we've just talked through.

16:04 As I mentioned, $760 is what we've now agreed with CMS, or that's what they will be they will be proposing. That'll be announced. We expect in the next few weeks with a view to it then going into the clinical lab fee schedule at the beginning of twenty twenty four. It goes into a period of consultation for a month or so, but I'm pleased that CMS CD CDL two, that's the clinical lab fee schedule group, and also the AMA voted in favor unanimously in favor of that price point.

16:35 And this is, again, I've shown this slide before, but it's worthwhile coming back to we're nearly through it. We're moving significantly now to the right hand side as we move towards launching cardio ENCODE. And similarly on the reimbursement pathway as we put out together our final MaldiX submissions. And we're now just starting to, as we start to bill, have discussions with commercial payers and insurance groups around payments going forward for Cardio and CoDE.

17:04 Much the same with lipid and code, albeit lipid and code's more advanced because we have reimbursement now in place. And we led with lipid and code, but the pull through for cardio has been strong as well. So both most early access programs contain both lipid and cardio ENCODE. And this is in the case of lipid ENCODE, this is for familial hypercholesterolemia or individuals who are struggling to metabolize cholesterol. So that high level of cholesterol circulating in the blood gives rise to, arthrosclerosis or a clogging of the arteries, and then the accelerated onset of heart disease. So a really important test and specific to individuals that, hypercholesterolemia. Smaller market. In this instance, it's about 1,800,000,000, but very focused in the in terms of the the products that we use in this area. And we have probably globally a globally leading test or the globally leading test in this area because it's not only looking at familial hypercholesterolemia.

17:59 It looks at the polygenic risk for the individual and also the heart disease. It uses cardio encode as well. Again, as I said, the market in terms of size of patient group is small, about 1,500,000 Americans estimated at risk of FH. And, again, earlier, cost and pricing on this, I'd presented slightly lower. It's a bit higher now from what we've done from the work more recently. Medicare are paying out around about $1,700 a test.

18:28 The private payers, the payer institutions, which represents about 80% of The US market, is about $1,200. That gives us I mean, and 1,200 is a is a good benchmark, but it also means that as we move into The US market to be competitive, I think I've said before in The UK, we we sell the product to the NHS at £450, £800 for private. But it means that we've got room for maneuver in terms of commercially winning that business. We have a low cost, entry point if we need to, which means that we can be more competitive on pricing. And importantly, at this stage, we want to anchor the product in The US market, so we will be competitive on pricing where we need to be. Then, again, the summary here, this is largely done. So we're now starting to get into the you know, more towards full launch for lipid encode.

19:20 And and the key driver for that acceleration in launch for lipid and code will be the synergy in group when we start to move to automated billing. So that that's a key part of what we're doing now. So, yeah, we're we're well advanced now on lipid and code as we move into this final quarter for for revenue generation in The US. UK, just an update. We we obviously have done a lot of work with the NHS to to implement lipid encode. It's an NHS ten year plan policy for them to identify twenty five percent of The UK populate or England NHS England population suffering with familial hypercholesterolemia,

20:01 but they're nowhere near that level from a testing perspective now. We've started to introduce the implementation in in the North Of England, started with Newcastle. We're now working with Sheffield and Leeds. Numbers are building, so that that's working well. We started the process in May. So in the second half of this year, revenues will be picking up more significantly. Yeah. Like, I we expect that in the second half, coupled with the growth that we're seeing coming on stream from The UK and Germany, that we're moving towards a 100% growth revenue year on year for the company. So that's pleasing to see. The bigger issues in NHS are typical of budget, so I struggle with finding the budget. But importantly, what we do is provide a much more comprehensive test, faster turnaround time for results at a lower cost than they currently do the testing internally. So it's sensible that they consider then putting more business our way. And with that in mind, whilst we've got the North Of England, we're currently now finalizing and working through here in London where Paul and myself are with UCL Partners and Bart and also with West Midland. So this cross application of what is a far superior test, faster turnaround at lower cost is a sensible step for the n NHS to look at. And that's so that's what we'll be discussing with them over the coming months.

21:19 Europe.

21:22 So better traction in the first half in Europe. We're pleased about that. That's good. Mainly out of Spain and Italy, but also now the first signs of Germany coming on stream. So in the second half, we'll have Germany revenues contributing to to what we're doing as well. Much smaller market, Spain, so not and and also somewhat fragmented by the regional setup in Spain. So it's not like working with, for example, the NHS as a whole or the FDA and and The US system, which is a little easier in terms of bang to the buck, easier to focus in some of those bigger markets, still fragmented in Spain and and somewhat in Italy too. But, nevertheless, it's our home markets where we started, and we continue to build out. So we're pleased to see the growth coming through from from The EU. And then just a word on on the RoCA test. So this is the acquisition small acquisition we made, a very small acquisition we made last year, but I'm pleased to say that guidance was issued a few days ago by NICE, and they've included that in the in the guidance for ROCA. If you have a chance to look at that, it's really pleasing because we are the only real product in this space. The evidence base that we provided is significant, and and NICE have now recommended the use of ROKA for those women who opt not to have risk reducing surgery when they are BRCA BRCA one or two positive. So they have a pathogenic variant.

22:44 They should undertake risk reducing surgery to reduce that risk. But, clearly, for those women who who don't feel that that's right to do that, then a surveillance monitoring tool is really helpful. And that's exactly what Roku is. So over the next few months, we'll start the discussions with the NHS with a view to it going being published around spring of next year. So it won't be before spring of next year before we see things starting to happen on that whilst it goes through this period of consultation.

23:14 Okay. I'll hand over to Paul, and he can give you an update on the financials. Thanks, Matthew. Good afternoon, everybody. So just a few pointers on the financials. Revenues up from $6,600 164,000 to 950,000. That's a 43% year on year growth. It's obviously modest amounts, but, really, this is continued proof of commercial traction. The the the geographic region of Spain, increased by 26%, and that's due to continue throughout the rest of this year. But the new revenues really are from The UK. Matthew's talked about the NHS signing up with, one of the AHSNs. That's generated revenues of a £131,000 so far this year, and that's really from a a standing still.

24:03 So we're now getting 40 to £50,000 revenue per month from The UK. So that's an annualized figure of about 500,000 from one AHSN. So you can see the the added benefits of rolling that out to the other thirteen, fourteen AHSNs in The UK, and that's a significant significant contribution to our group revenues. As always, the products, lipid ENCODE is still the largest seller for us that represents, just over 40% of our revenues, followed by thrombo ENCODE and SUD ENCODE with a little bit from Cardio Encode. But Extremadura region, as Matthew said, is due to take up the public health

24:45 contract with Cardio Encode, so that should be that shows some contribution in the second half of this year. From a margin perspective, we've got a nice increase from 43% to 49%. Two main reasons there. Firstly, in Spain, we've managed to reduce the pricing pressure from our key suppliers by passing on some of the price increases through to our customers. We have we we mentioned in the finals that we'd had, yeah, some inflationary pressure there, but we've managed to counter some of that. But secondly, we've always said that the geographic split is going to benefit the gross margin line. Historically, Spain has had gross margins of between 4550%.

25:34 UK is around 60%, and The US should be 70%, 75% plus. So we are seeing the group benefit from those UK revenues at a better margin coming through. So £450 we're getting per test from the NHS and £800 from private payers at this stage. Operating losses, increased to 3,600,000, and, that's expected. Salaries represented half of that increase with the, with other professional fees, as we gear up to commercial, launch in The US. And then, we've got a slight, increase in, adjusted EBITDA losses there as well. So that leads to cash balances of 5,200,000 at the end of June, was 9,700,000 at the end of December twenty two. So we've had cash burn of about £750,000, a month. So that's, due to continued again as we increase our infrastructure and ready for readiness for commercial launch in The US.

26:35 Very good. Thanks, Paul. Okay. So starting to round up. This is the key events, new cut, and and news flow that we set out. It hasn't changed much from what I presented last time simply because we've delivered most of this now through as we move into quarter four twenty twenty three. So all of that to the left has been done, and that's the outlook for the next few quarters moving forward. So and those red dotted lines represent the new revenue streams coming on. So that's Germany, UK, NHS, and and US now as we start to move from the early access program into commercial revenue generation. So to summarize, yeah, the key is in the final quarter this year is to convert those US early access programs into commercially generating revenue pieces, and that's what we're we're firmly on with now. I'm spending a lot of time making sure that happens.

27:29 Our benefits investigation program starts from the beginning of October, and that means for every patient we start to see where the physician is then prescribed them now on one of our genetic tests, it starts to go into our automated billing process with Synergene. We're advancing our clinical utility programs in preparation for the MALDIX submission for cardio ENCODE. That'll be in the fourth quarter, possibly early quarter one. Ongoing discussions with the FDA around cardio ENCODE approval, we expect that in quarter one of next year. Expanding what we're doing with the NHS on lipid encodes. That started, and that's an ongoing process too. And then we're also likely to introduce cardioENCODE to the NHS. A lot of interest in the paper that we put out at ESC and the high impact journal that it we published in the first paper, I think, will also bring more focus on the NHS to what we're doing with CardioENCODE.

28:23 Germany started, so revenue generation there, and we we expect our EU ongoing strength to continue in Spain and Italy as we develop Germany as well on on the EU side. The marketing, not not a lot of headcount ex extension here because we we've got a pretty strong mechanism by which we're we're going around the institutional build process using our online sit up system. So that that's working well, but we may well have a a little bit of sales support on the West Coast. We have a number of programs that are starting to pick up there. So in a numbers basis, we may well strengthen the team there. NICE, I've just mentioned. We've now got the the approval there, so that's pleasing. But most importantly perhaps is we we're gonna shift the business model into rapidly growth in revenue, really keep the cost base tight and chase down breakeven profitability over the medium term.

29:18 Given the strength of what we can see in revenue growth and our cost base, which we're keeping really tight, we we want to really create a new exciting certainly in the sector, different business model here. We'd like to get strongly cash generative because we can see that the opportunity in sales growth is is significant. So that's, you know, a a new style, new business look to to somewhat differentiate us within the sector and drive down and really create a high cash generative model. So that's where we're we're moving the the business model. So that that's pretty much it. I won't there's a few extra slides, but they're really only, appendices. So if I hand back to Mark, we're done on that side, Mark, if you wanna open it up to Matthew, Paul, thank you very much indeed for updating investors.

30:07 Could I please ask investors to continue to submit your questions just using that q and a tab on the right hand side of your screen? Just simply type in your question at the bottom, press send. But just while Matthew and Paul just take a couple of moments to review your questions submitted already, I'd like to remind you that a recording of this presentation along with a copy of the slides and the published Q and A will be available via your investment company dashboard. Paul, you very kindly agreed to moderate the q and a. So if I may just invite you to open up the q and a tab. If I could ask you to read out the questions where it's appropriate to do so, and then I'll pick up from you at the end. Sure. Thanks, Mark. So Alex asks, how can you drive faster adoption of your products by the NHS? Well, I think, first of all, show that we're delivering a a fabulously strong product in the North Of England, which is what we're doing, and the North Of England then become advocates for for what we're doing across the NHS.

31:00 That's key. We're taking that same model and cross applying it. So it's growth by trust or by HSN, I think, as Paul mentioned earlier. So it's taking what is working well and accelerating that. I think the other point, though, that's a key driver of it is budget in the NHS. So, you know, I haven't got a magic one on that side, but but what we can do is make sure that we're highly competitive versus in house processes, and that's not only the quality of the product turnaround time, but the cost as well. Thanks. And then Marshall asks, what's the typical length of time from engagement to adoption? And do you see this time frame reducing as adoption by others increases? I assume this relates to slide 13. I think it was with the early access programs.

31:48 Yeah. Yeah. I think you're right. I think it's The US. So the way that we've geared it up is that it's become a quarter on quarter process, which I like, and then there are three parts of the engagement, the early access program, and then we move to commercial adoption. So that mechanical way of doing it is is a really clean way of running it with the sales team. It means that when we go to an account, we convert the account, we engage them, we go through early access, and then we they go into the commercial adoption phase. And that's where we are now with the early programs that we started in quarter one, quarter two of this year. So, yeah, that that's the intention is to carry on running that model out on a quarterly basis because we can see that 20 client institutional accounts a quarter is is plenty strong to drive that on.

32:36 That's exactly where we're going to be. So as long as that that model continues to deliver in the way that it is so far, no reason to believe it won't, then we will we'll do that. But it's taking in terms of typical length, I would say, from the moment, well, if you take the quarter two ones that are now converting, it takes about six months from engaging, advising through to them them commercially buying if we're using an early access program. Now as we grow profile and people become more aware of the products, there'll be less early access program and more people coming in because they've heard network wise or profile wise that this product is something that they need to use. So it will increase the speed of adoption. So at the moment, probably up to six months, no more than that, really, realistically, from the beginning when we started, which means the first round of group, the first 20, if you like, are now starting to move into commercial adoption phase, which is where we are with them.

33:31 Okay. Steven asks, are there any other comparable tests to yours that are at the same stage or more advanced? So there's I don't think there's anybody more advanced because, you know, in terms of what like, just as a measure of that, there are no polygenic tests for cardiovascular disease currently, as a diagnostic on the market, certainly not being provided through the FDA process. So that's a key point. There's nothing on that side. There are there are products that are more on a research use only basis, let's say, that are claiming to have polygenic positioning, but they're not as advanced in terms of where we are with clear approval cap accreditation and so on. So we don't see anybody directly competitive. And, obviously, from what we do, we have IP.

34:20 We have a significant amount of evidence base built over the last fourteen, fifteen years. So it it it depends when you say competitor. At the the academic level, there are people coming, but we don't see anybody quite directly as to to where we are. And, hence, we're keen to keep that, you know, in front of the pack, get our products into market as first mover positions, and take advantage of the the fact that we've developed the products and they're now starting to see strong uptake. Alex asks, how big is your internal sales force, and how are you expanding in new countries? Are you employing local sales teams? K. So we're very focused. We we haven't got the bandwidth or the cost or the investment to be able to put out other than the the key markets in which we can see growth. So those are Spain because it was the original home market from when we acquired the the two companies and the technology to start the business.

35:18 Expanding that through into Germany now, which is a key step for us and and using Italy, we've got a sales growth in Italy too. UK because it's our our backyard, and that's where we're we're growing from here. So the the corporate team and the the strategy for the group is driven from from The UK and The US because it's the biggest market globally for our our products. So in those markets, the the sales teams are very tight, especially in the core markets of The US and Spain because we're building out a model whereby using our digital systems, we want to expand, use the sales team to introduce the test, advise, educate, sell the test, but then move on to the next client account. We haven't got the ability to invest in hundreds of salespeople running around The US, so it has to be very focused and at the same time, grow the top line. So very pleased because the sales team for The US came from Invitae.

36:14 They're the cardiovascular group. There are four of them who came across from Invitae who were very experienced in cardiovascular selling, and that's been, so far, a big success for us as we've now launched the early launch the early access programs into The US. Okay. And Richard asks, when you indicate breakeven in the medium term, is that in 2024? And, also, can you also indicate what sort of quantum you might be looking to raise in the next round? So I'll maybe kick start that. Yeah. Got me. It's not going to be 2024. Twenty twenty twenty twenty two was really a a year of high investment in to set up a lapse. Obviously, The UK lab in Hammersmith, that cost well over £500,000.

37:00 The US lab cost well cost well over $1,000,000 to set up, and we disclosed that information in the year end accounts. Twenty twenty three has been really focused on, setting up the infrastructure for commercialization of, Cardio Encode and Lipid Encode in The US in the second half of the year and getting traction on The UK sales. 2024, we're expecting, you know, FDA approval in q one twenty twenty four. Hence, we're not gonna get full year benefits from, from the Cardio Encode kit sales in The US. And, and we and we probably won't get full year benefits of The UK rolling out to other a IHSNs as well. So I think cash cash burn in 2024 will be a little bit higher than 2023 as we gear up for that commercialization.

37:53 But then I think the corner would be turned in, 2025. So I think about halfway through 2025 is when we start breaking even, and then 2026 would be full year profitability is what we're aiming for in our current trajectory. And on the second half of that question, the quantum, my gut feeling is, you know, circa 8,000,000, something like that. We have quite a lot of headroom from a a VCT stroke EIS perspective. We are, knowledge intensive company qualifying, so we have a lot of headroom there. So at that sort of level of funding, you know, there's a strong chance that that takes us through to breakeven and, and potentially that be being our last fundraise.

38:43 That's great. Anything there, Matthew? No. I think that's right, Paul. I mean, you've you've got it about right. So the the key and maybe this is also a finishing comment if you're gonna say that, Mark. We are scaling the company now properly. By that, I mean, the key core markets that we set out to address are starting to come into focus, especially The US. The US is where we we will really ramp up and and turn the company into, I'd like to say, cash generating machine over the next over the medium term. So it isn't '24. It's into '25. It's roughly speaking, yeah, eighteen to twenty four months of over that period from where we are. 8,000,000 is about right, and that gives us a really strong opportunity to drive the company into strong profitability, cash generative position.

39:29 On a sales line, and this is the thing that's perhaps the most exciting, we know that the regulatory position is changing. We have a first in class product, highly attractive, and a price point so that we can be competitive where we need to be. So it it's getting exciting. There's a lot happening in the company, but all eyes on The US and growing what we're doing there. And that's kind of a finishing comment as well, just adding to what Paul has just said, Mark. That's perfect. Matthew, Paul, thank you once again for your time this afternoon and for updating investors. Can Please ask investors not to close this session as we'll now automatically redirect you for the opportunity for you to provide your feedback in order the company can better understand your views and expectations. This will only take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team at GENINCODE PLC, we'd like to thank you for attending today's presentation and wish you all a very good afternoon.

40:18 Thanks, everyone.