GENinCode Plc (GENI.L) Earnings Call Transcript & Summary

Good afternoon, and welcome to the GENinCode Plc Interim Results Investor Presentation. [Operator Instructions] The company may not be in a position to answer every question received during the meeting itself. However, the company can review all questions submitted today and publish responses where it's appropriate to do so. Before we begin, I would like to submit the following poll. And I would now like to hand you over to CEO, Matthew Walls. Good afternoon to you.

Good afternoon, Alex, and good afternoon, everyone. Welcome to the interim results business update for GENinCode. I'm here with Paul Foulger, CFO at the Cavendish broker offices in London, Central London, for those of who you who know roughly where we are. We've got quite a bit, so I'm going to move at some pace through the presentation. We'll start with a brief introduction and move through the results, take a look at the U.S. strategy, EU and U.K., a little bit of an update on ROCA, and then finish on the financials. I think, again, just to breeze through who we are as a company, we're a genetic testing company, specializing in the area of polygenic risk assessment in and around cardiovascular disease. So this is for the prediction and prevention of cardiovascular disease using genetics. We're revenue generating. And as perhaps most of you are aware, that's starting to move quickly now. Test products are regulatory approved and we have an established business, which we started in 2007 with Ferrer Pharmaceuticals. And then in 2018, we spun out those 2 businesses to form GENinCode. Globally leading evidence base, so significant. And over the last 12 months, we've put a lot of new publications and advances around polygenics into the field. We'll touch on that as well. IP protection around our core products, and we're not one product company, we have several. And the main focus of why we're interested in genetics and cardiovascular disease because at present, genetics are not part of the risk assessment process. And we've thought for quite some time. This is an important piece. It needs to be added into clinical risk assessment so that you can get a comprehensive risk assessment of the patient. It's a significant area in terms of disease-burden globally. So it's the leading cause of death worldwide, significant across both U.S., U.K. and Europe, accounts for roughly 1/3 of mortality. A significant economic burden to society and mankind. And it's our main focus and interest is around accelerating the use of genetics for risk assessment in cardiovascular disease. Okay. So moving on, this is the interim report summary. So in the first half, we saw a 46% increase in revenues and not from a position of starting at relatively low levels. We're now starting to see more year-on-year significant growth, which is what we intended to do and what we're now starting to deliver. Our first U.S. commercial sales for LIPID inCode and CARDIO inCode are now starting to come through. The De Novo process with the FDA, we've completed the substantive review. So that's -- if you recollect, for those of you who are familiar with the company in November '23, we filed at the main submission, the De Novo submission. It's taken the best part of 6 months for the FDA to work through that and finish the substantive review. They've asked for further additional information, which we're providing them with and we'll do over the next few months, and we expect to provide an update on where that is towards the end of this year. I'm pleased to say the process has been very solid, good, constructive discussions with the FDA. So the process is moving in the right direction. And we hope that over the coming months, we can then satisfy that and move to full approval at the end of that process. We've provided a lot of updates into the market around the evidence base of our product, notably CARDIO inCode and when I say we, that's mainly our partners, Kaiser, Kaiser Permanente in the U.S. We put our first major publications earlier this year. And then subsequently, we presented more recently at the European Society of Cardiology, around self-reporting and also high levels of LDL alongside polygenic risk score, we'll touch on that as well in a few more slides. Our U.S. commercial programs have started again with big institutional groups. So we're excited about that. And we announced last week the new arrangement with the FH Foundation in the U.S., the lobbying group for use of testing for familial hypercholesterolemia and Lp(a). We received Notice of Allowance, so that's patent for CARDIO inCode. We're expanding in the NHS with LIPID inCode. So we started last year in Newcastle. That's now drifted down to Leeds and Sheffield. So we've seen a pickup in volume there, which we're pleased about. And also on top of that, we're now looking at extending that into the North West Coast, that's Manchester and Liverpool. So really pleased to bring that alongside what we've done in the North of England. Importantly, that group are now meeting their targets against NHS plan. We're seeing growth in Germany, too. So really pleased with that and good solid positioning in Spain and Italy, they too have had a good first half. And also the pilots progressing well in Spain, Extremadura and we have other regions now coming into focus there as well. So we should see further expansion of CARDIO inCode across Spain, too. And again, just to reiterate, we received NICE guideline recommendation for ROCA, that's the Risk of Ovarian Cancer Algorithm, a Software as a Service process, and I'll give an update on that in a few slides. We successfully completed the fundraising at the beginning of the year. There weren't many secondary placements in the main market rather than in the AIM market. So we're very pleased about that at the beginning of the year. That's helped us scale and power up and what we're doing as a group over the past 12 months. We have a pretty solid cash position, driven by the fact that our costs are reducing, revenues are moving up. So we're where we expect to be at this point in time. Okay, moving on. That's the product set up. So you can see the glance where we are. Europe has most of the products regulatory approved and our main market in Spain sells most of those products. As we come across into the U.K., it's mainly LIPID inCode and CARDIO inCode. And again, into the U.S., LIPID inCode and CARDIO inCode is the main focus across the company in terms of growth in revenues. In simple terms, it's a relatively straightforward process. We collect the samples from hospital institutions, clinics. They go off to our lab. We extract DNA from the sample, process that through our risk scoring bioinformatics, and then report that to physicians. So a relatively straightforward process, but to do that, we use our own online system, it's called SITAB. And we don't often talk about it, but it's an important backbone of the operation, and it's growing significantly, not only in Europe and the U.K. as we've moved that, but also now into the U.S.. So we have a harmonized system where as we bring the products onto the system and they're updated, that then allows us to unfold that then internationally as we roll the products out. So a really important backbone. And I've just put a slide in there just to explain that. It handles everything from ordering through processing. And increasingly, as our volumes build, it's becoming more and more important to us that we align it with a local market position, through processing into the risk scoring, the algorithms is risk score, the physician for the patient samples, and then we report that back to the physician. And that process and that system is all part of our onboarding as we grow our volume across the company. So the same process and the standards are applied. And that allows us not only to be very efficient in the way that we roll out, but increasingly allows us to accelerate the speed at which we do things across the company. It's a really important piece. Our backbone that's not often seen, but I think it's worthy of bringing further attention to our investors. Okay, so moving back to the U.S. This is the market -- a significant market in terms of cardiovascular burden around 86 million Americans suffering with cardiovascular disease. It accounts for nearly 1/3 of all mortality in the U.S. heavy cost burden and also, in some ways, running out of control. So you can see in the bottom right there, the numbers are estimated to escalate significantly over the coming years. This is where we're rolling out. So I'll continue to share this slide because I think it's a good representation of where we are as a company, how we are extending and growing the market, especially in the U.S.. Those areas in yellow or those groups, institutions in yellow are the ones that are on boarding or have on boarded, there are about 20 of them. And most of them relate back to the work that we did last year on the early access piece. So they're now starting to engage with us. And as I said earlier, on the SITAB process, that's part of that onboarding process. So all of them are now plugging in. It's an interesting note that whilst often, we talk about difficulties in implementing in the U.S. because group's companies can't integrate with the epic systems and other electronic medical record systems. We're finding that the test processes we're working through are being accepted quite quickly with our system. So I'm pleased about that, partly because from a polygenic perspective, it's difficult to get the products that we have elsewhere. So they're accepting that they'll use our systems to order online, which is a helpful process for us as we accelerate onboarding across the U.S.. And then notably, on this next slide, in California, probably one of the busiest areas for us, partly because our labs are there. But the community of group is now starting to pick up and gain interest and order from us is also growing now, I think the state, perhaps the biggest state for us in terms of growth certainly over the short to medium term. So the sales and the business has started now to grow in the U.S., so we're excited by that and also excited by the partners we're working. These are the main key opinion leaders, influencer sites across the U.S. And also, I'm pleased to say that a lot of these sites the individuals who work with us and they are part of our publications and have authored them are also part of this too. So it's a good network, a good community to build within. And this is just a summary of where we are for each of the -- for CARDIO and LIPID. I'll walk through LIPID after starting with CARDIO. So CARDIO, we started the onboarding process, as I mentioned. There is growing demand partly because we're bringing these products into the market where there aren't really available. It's not a product class that is well known. So there's a degree of education we have to advise, explain, share the reporting and as we did last year, go through the early access where we gave these products free of charge to physicians. Now they're getting more comfortable with them. Those physicians who are using them start to use them in small numbers to start, but then typically, as they get comfortable with it, the numbers start to escalate, which is really exciting from the point of view of individuals becoming aware of the importance of the genetic risk at a patient level. And the other point just to say on that patient level, this is when we're looking at the genetics of the individual, this is truly personalized risk assessment data. And you'll see as we go through this presentation, it's an important feature of aligning with the new therapies coming into the market. So as a result of the onboarding, we've got our first U.S. revenues coming through, not significant, but significant in terms of the fact that the first revenues but still building, and we expect to see them continuing to build in the second half and beyond. The regulatory processes for the lab is set up. So we're currently sourcing and delivering our test processes from our Irvine lab in California. And as I mentioned, we went through the substantive review process with the FDA, which finished a couple of months ago, and we're now into finalizing and providing additional information to them. Reimbursement. Paul, I think you're just moving the slides, let's go back. So coding wise, we have coding for CARDIO inCode 0401U. We also have our pricing. It's between $500 and $760 a test. The reason I say that is, I've been in negotiations with them around moving that a little bit. So we will know this week how much -- hopefully, it's going to be a little bit higher than that, from the discussions we've had. But we will be then -- that will be part of the clinical lab fee schedule for CARDIO inCode for Medicare from -- in 2025, that's going into the schedule. When we get through the FDA process, we will also be submitting our MolDX process for CARDIO inCode. That will allow us to gain Medicare coverage. So in the first instance, at the moment, these tests are being paid for on an out-of-pocket self-pay basis. As we move forward with Medicare, we then move across into the insurance market and Medicare provision as well. But that will be post the FDA process. On the commercial side, then we've got our key opinion leader focus, education and SITAB implementation. On the commercial payer process, we've started discussions and we've now been recognized as now out-of-network payer provider. And as I mentioned, we provide the testing on a service-based approach to health care institutions, clinics and also executive health is becoming a bigger feature for what we're doing. So this is the paper that was released in March, a really important paper perhaps for us, a big milestone for the company. And the first globally where we have clinical data now on the importance of polygenic risk scoring at a population level. So this is a study over 14 years on just over 63,000 patients. And it went to show the genetic risk are an independent risk factor, independent of clinical risk. So for example, smoking, physical activity, eating habits and so on, so totally independent. The study showed that over that period, our CARDIO inCode was consistent in its ability to identify risk across sectors in male and female and across ethnicities. Again, that's very important from the point of view of introducing a genetic test on a population basis. It provides additional risk stratification and most importantly, identifies individuals at high risk who would benefit from statin therapy or more intensified statin therapy. We'll talk through this in a moment as I move on. And then it comes in and alongside existing clinical risk factors and functions. So physicians who are using the testing would go through their existing clinical approach, and this would be an adjunct to the testing and importantly provides that genetic risk piece. We've then subsequently in the last 12 months, provided 4 or 3 of the studies to make 4 in total in and around different aspects of using CARDIO inCode at a population level, the polygenic risk assessment. The main publication that went on in March, but also we have another publication coming later this year on Lifestyle. We'll have likely a further publication on LDL. This is the reference of polygenic risk alongside cholesterol and in terms of family history, self-reporting. So when a patient visits the physician, and the physician asks the question of do they have a family history of heart disease, CARDIO inCode provides a much more accurate risk assessment of an answer to that question. So we're looking now at the familial risk of an individual for heart disease. The other thing that's happening is coming quickly, and we're very pleased with the American Heart Association issued a policy statement around the use of polygenic risk scoring, recommending that where physicians see that is at intermediate or borderline risk. So they're uncertain of the risk of the patient at that point clinically, that they should refer to coronary artery disease, polygenic risk scores as an additional risk enhancement to their clinical position. In addition to that, we've got the European Society of Cardiology also coming with a policy statement, and we expect that to be additive to this, again, moving physicians into a mindset that genetic risk is an important factor to be taken into consideration alongside clinical risk. And it's important because it provides, perhaps most importantly, a lifetime risk for the patient in and alongside the clinical risks, which are typically moving at different points through a patient's life. The baseline of a genetic risk being a fixed risk through their lifetime. So really important to start including that in terms of their risk assessment. Okay. So just to take a minute or so, just to explain to you how this then is implemented clinically. This is the primary prevention standard of care and guidelines for the way a physician assesses the risk of a patient for heart disease. And it's factored into clinical risk functions and equations. There are different equations across Europe and the U.S., but they all typically work around a 10-year risk assessment horizon. And those individuals who are at low risk are below 5% probability of an events over the next 10 years. those are borderline or intermediate between 5% to 7.5% or 7.5% to 20%, and those above 20% are high risk of an event. Now they're all based on clinical risk factors and with the advent now polygenic risk, we're able to add to that the genetic risk scores for the patient. So you have, on the left-hand side, an individual in green with a low genetic risk score or an intermediate genetic risk score in the middle or a high genetic risk. And depending on what the patient's genetic profile is, is then down to the physician in terms of their treatment pathway. So if the patient has a low clinical risk and a low genetic risk then they'll likely maintain and keep the patient advised of their cardiovascular risk, but maintain their current treatment approach. If the patient has an intermediate genetic risk and an intermediate -- borderline and intermediate clinical risk, then the patient needs to be advised that they have intermediate risk, and patient together with the physician can watch and ensure that as the patient ages, if there are any other risk factors that are clinically aligned, then the patient can be advised around that, in relation to their intermediate risk. But perhaps the most valuable piece for the genetic risk is where you have a patient who is at borderline or intermediate risk, which is the main group of patients who are classified at risk from cardiovascular disease, who have not been recognized at high genetic risk. And in that instance, the patient would then be moved reclassified from borderline-intermediate into a higher genetic risk category or a high risk category. And then the actions would be taken to intensify or onboard them to statins or treatment therapy or look at reduced blood pressure therapies. This is a really important slide, it will be the way in which the genetic risk scores are implemented in terms of the systems, both Europe, U.K. and in the U.S.. And we expect to see the ESC, European Society of Cardiology make a policy statement on the reclassification of risk using polygenic risk scores early next year. As a result of that, this slide which was created a couple of years ago is now becoming a little bit out of date, but the figures in some ways, when we did this estimate of the market for the U.S. It was just weren't aware of polygenic risk score and there were no guidelines in the market as they're coming, the size of the market, especially if it goes into full guideline recommendation, the size of the market will increase significantly. And when we did this market exercise a couple of years ago, it identified 21 million patients who were at what we're currently classified clinically as low or intermediate risk. And of those, when we ask them if they would prescribe a risk assessment tool, a polygenic risk tool to their patients, about 8.5 million patients were identified who were physicians would prescribe that. Well, with the guidelines moving in this direction, it's increasing the market opportunity for us. So we expect that the next time we update the market information, this is likely to be a much bigger patient population in which we apply polygenic risk assessment. The pricing, as I mentioned, $500 to $760, we'll know more on that this week. But in any event, there is a very good price for us. Our cost of goods is significantly lower than that. So we expect to see strong significant margins from the CARDIO business as it grows, especially in the U.S.. And this is then a summary of where we are at the regulatory level, as well as the pricing and clinical adoption level. So at the clinical lab fee schedule pricing it's between $500 and $760, self-pay around $400 is where we are, that's the out-of-pocket payment. So for those patients who don't have coverage, and at the moment, all of our revenues for CARDIO inCode over until we go through to insurance cover and Medicare cover will be at that $400 mark. Regulatory, well, as I mentioned, as we move towards the end of this year, around quarter 4, we expect to get an update and a discussion around whether we have approval or maybe update the market around quarter 4 of this year. We're clear CAP approved. We have a significant evidence base in this space. And increasingly, the guidelines are now starting to change. So we're very well placed to accelerate and grow at CARDIO inCode over and above its current sales that have started now from our lab in California. So the process will continue to grow from the lab, but accelerate then as we get through approval and move into a kit process into next year. Okay. Moving across the LIPID inCode. So LIPID inCode is the main revenue-generating product for us. So it received Tier 1 genomic status. So that's alongside BRCA and Lynch syndrome, on the oncology side. And this is the first genetic area and disease area in familial hypercholesterolemia that's being recognized by the CDC in the U.S. We have now started to -- the product is now being taken up in the market. And most of those onboarded institutions I mentioned earlier are taking this product in terms of as selling, and we're quite preferable to move in this product because it has reimbursement coverage. It's a smaller market, but again, it's still a growing market, not only because on monogenic side, that's recognized at about 1 in 200, 1 in 250 individuals globally suffer with FH. But in addition to that, as we bring polygenic risk assessment into the test process and to the physician, we start to identify more patients at high risk of inability to metabolize LDL cholesterol, that's what we're looking at here, high levels of LDL cholesterol. And we're now identifying a bigger population of patients, which means that the physician is able to -- even if they're not monogenic FH, there are other reasons why the patient should be treated because they're at high polygenic risk of LDL. So the market is likely to expand. And the other point just to note on identifying these patients at the moment, whilst there are 1.6 million estimated patients who suffer with FH, the number of tests that are currently undertaken to identify that is likely to be significantly higher. Finding these individuals in the population means we have to test them, identify them. So it's not a one-to-one comparison in terms of testing. We've recently, last week, announced the collaboration with the Family Heart Foundation, and that's not just the group who lobby for awareness of FH and Lp(a), but also the partnership with the other groups that I've highlighted there in the fourth paragraph. This is the beginning of a very strong partnership arrangement with these groups. They're not only collaborating with us to roll out the program at a primary care level for FH and Lp(a) detection, but these groups are also starting to independently at this program, buy from us on a system-by-system basis too. So very pleased about the work that we're doing with them. It complements everything we're doing in the U.K. and in Europe. So a really solid position, and also is underpinned by what I started with was the SITAB system. The SITAB system is also part of the process by which will then lead these products and testing into the U.S. market. I mentioned is $1,200, that's a combination of those 4 gene areas that we test for that's LDLR, APOB, PCSK9 and LDLRAP1. All of those are the main FH monogenic genes, which are reimbursed at those levels and average at about $1,200 for a test for insurance payment. And in this instance, we've got green on all of these. So this is why we're pushing and moving the product as swiftly as we can into the U.S. market, good reimbursement, good self-pay, clear CAP approved, strong evidence base. And arguably, our test is globally the strongest. It's not only FH, but as I mentioned, polygenic LDL, polygenic coronary artery disease, Lp(a), we also cover that here in the U.K., and we're looking now to introduce that into the U.S., and also statin intolerance. And at the same time, the guidelines and the increase of the recognition of the product to the Tier 1 status for public health. Quick update on the NHS. So we started in the north of England. We've extended from Newcastle down to Leeds and Sheffield. So very pleased about that. And we're now moving across on to the West Coast. That's the North West Coast to Liverpool and Manchester where we're currently in discussions about implementation there, too. So that will likely be the second group in and also down in London as well, we have other groups coming on board, too. So we're very pleased about that. And again, it's based around the strength of the testing we're doing, the fast turnaround time and the low cost in which we're providing it to the NHS. So this is arguably a no-brainer for the NHS to be able to take a low-cost, higher-quality product with really fast and accelerated turnaround times and importantly, provides access for the new therapies that are coming into the market by identifying those patients with genetic risk for which the new target therapies are positioned. So as I mentioned earlier, truly is a personalized medicine, precision medicine approach. So that's where we are in terms of the North of England. We have the North West coming on. And in combination with our pharma partner friends, we're looking at then further use of their not only existing lipid lowering medication, but new therapies coming into the market. And we'll also provide an update later in the year as to where some of those discussions are with pharma as well. On the EU side, again, strong solid growth, mainly from our Spanish team, good solid performance in THROMBO and LIPID inCode, LIPID inCode, again, dominant in this market. It's a smaller market, but nevertheless, it's our heritage markets where we started as a company. It's exciting because not only are they growing strongly, they're doing a solid job. But at the same time, we have the new regions, Extremadura where we start with CARDIO inCode, but we have other regions now coming on for CARDIO inCode pilot testing as well. So Andalusia, Catalonia is now planned, the Basque region and also Madrid, a good collaborative positioning too. So that's been a part of the growth that we've seen over the last 12, 18 months, which has been solid for us in anchoring what we're doing in Spain. And Italy has had a good first half, too. So pleased about the progress there, and then just finishing on Germany. Germany is slower in some ways to scale, but nevertheless, that's growing steadily, solid position in Germany as it's grown. There's been a lot of education requirement. It's a steady, slightly more traditional market in its approach, but it's following the same position as the NHS model. So good, solid, steady growth but from the EU market. And the other point just to make on that because we're keeping the cost base tight in the company, each of these markets in Europe is its own market, it requires a lot of bandwidth and focus. So whereas, for example, our bandwidth when applied in the U.S. and certainly in terms of the FDA, gives us a closer approach to a much bigger market opportunity. So whilst the European market is valuable to us, we have to carefully align the amount of resource we expand on some of these markets because they are somewhat disparate by comparison with the bigger markets. A quick update on ROCA. Not -- we obviously received the recommendation at the beginning of the -- March of this year. So very pleased with that, it was a great result. A lot of time, work and effort to get the recommendation there. And as a result of that, now we have 6 regions, 2 in London, 2 in the Midlands and 2 in the North of England, now assessing and preparing to onboard ROCA. We expect to give a further update on ROCA in the coming months. But for us, this is an exciting product. It's not genetic in this instance. It's a software algorithm. Looking at the cancer antigen 125 and changes to that. The rate of change and changes in that, that the algorithm recognizes in terms of a woman onsetting and staging for onset of ovarian cancer. And remember, this comes post the BRCA test. So when a woman has been identified at high risk of breast or ovarian cancer and decides not to go ahead with risk-reducing surgery, then this has provided us a recommended test for surveillance. So it can take -- the testing is undertaken 2, 3 times a year on an ongoing basis, while the woman is at risk of ovarian cancer. So we'll provide a further update over the coming months on ROCA, but good progress now coming through on the NHS. And Switzerland, we're just starting to prepare to take the first sample through from -- for the Swiss market as well. And we won't be moving more broadly until we've anchored the NHS and it was mainly the NHS before we then think about moving further field smoother markets, again, partly from a bandwidth perspective. Okay. I'll hand over to Paul.

Thanks, Matthew. Good afternoon, everybody. On the financials, first half revenue is up 46% to GBP 1.4 million. Modest number still, but good solid growth, which we've enjoyed over the last couple of years. From a product perspective, LIPID inCode remains our biggest seller. That's more than doubled to GBP 860,000. That's followed by THROMBO, which represents about GBP 300,000. That's grown by more than 20%. And then SUDD inCode, GBP 200,000 and then CARDIO in fourth place. Just a reminder, all 4 of those products, [ C-Mart ] selling in Europe and all growing. In the U.K., we've enjoyed good growth at GBP 320,000 from the U.K. That compares with just over GBP 100,000 last year. So remember, we've had the full 6 month benefit of the NHS contract that we pulled in, in May 2023. And that's solely selling the LIPID inCode products. In Spain, Spain represents about GBP 1 million. And when we say Spain, we refer to Spain, France, Italy, a couple of other countries there as well, but the main geographic office, as such, we referred to as Spain. And then the U.S., GBP 71,000 of revenues coming in there. So hopefully, all 3 of those regions will continue that growth for the rest of this year. From a margin perspective, margins have improved to 53%. The product margins are about the same. But as we've said in previous presentations, the geographic margin mix has improved significantly. So Spain remains around about the 46%, 47% margin level. The U.K., which is now coming up fast, is around 70%, and the U.S. is coming in at over 80%. So that mix will continue to improve that gross profit margin percentage for the rest of the year as the U.K. and U.S. revenues do increase. Reduced operating losses, so our overheads have come down significantly, over GBP 1 million. So we've had reductions in salaries, and that's mainly the U.S. levels there. So the levers we're replacing on lower salaries and working differently with the staffing levels we have over there. Consultancy fees and legal and professional fees have come down about GBP 0.25 million. We had some one-off fees last year, which are non-repeatable. So we're continuing to enjoy savings in those lines and marketing and market access costs. When we set up a partnership with our revenue cycle manager in the U.S. last year, we spent about GBP 150,000 on setup fees. That's nonrecurring. We're paying them a variable cost in proportion of revenues this year. So continued savings there and development costs, things like FDA submission costs at the end of last year, the non-repeatable costs. So we should continue to see those savings in the remaining 6 months of this year as well, which leads to a bit much reduced adjusted EBITDA a line of about GBP 2.2 million versus GBP 3.4 million last year. So the message in the income statement there is very much increased revenues, improved margins, decreased overheads, improved adjusted EBITDA losses and basically moving towards a breakeven level as soon as possible. And we're talking 12 to 18 months still there, but very much improving numbers, and we see that continuing very much into the short to medium term there. Cash balances, GBP 2.9 million at the end of June '24, got a cash runway of about GBP 400,000 a month, and we've completed that, that's net of that fund raise that we completed in January '24. Back to you, Matthew.

Thanks, Paul. Okay. So just starting to wrap up. I've included on here just some of the key points over the coming months that we expect to give an update on. So we expect I think later this week, we should hear the clinical lab fee schedule pricing for '25. Hopefully, a bit up on the $500. In any event, at that level, it's a significant margin position for us, but I'd like to try and get a little higher if we can. NHS updates, we expect to give those over the coming months, mainly around expansion. And also then across into the pharma side, we're working with a number of pharma groups around how we better identify patients most in need of lipid-lowering therapies. And certainly, those therapies where they are costly on a precise -- precision-based, personalized based approach. Lifestyle publication, I mentioned earlier that will come from Kaiser a little bit later this year. And also then we move then into expectations around where we are with the FDA following our additional information into them. We're still targeting approval at the end of the year. I see no reason why we won't hold that out for now. I mean we don't know what the -- how the discussions will fail on the additional information, but we're certainly well on with that and in discussions with them over the coming months to finalize. So that's when we're aiming to try and get either an update or aiming for approval if we can by that point. Kaiser will be presenting at the Cardio Genomics Conference at the ESC towards the end of this year, again, presenting on CARDIO inCode, ESC policy statement in the early part of next year. And then on the basis that we finalize things with the FDA, we'll then file our MolDX Medicare submission for discussions with Medicare for CARDIO inCode that is. And in the meantime, just to reiterate, it's a self-pay process for CARDIO inCode, whilst we don't have any insurance coverage. And that's pretty much the only other pieces then are updates and expansion beyond there. Increasingly, the business is now all about building, scaling, growing and selling. There's less in terms of development, less in terms of regulatory approval. And then just to wrap up there. So it's all around expansion CARDIO, driving through the FDA process, expanding the NHS program and in Germany, too. Also, the new pilot programs that are coming on in Spain, Catalonia, Basque region, Madrid and Andalusia, then starting to see some traction from the NHS around ROCA. And as Paul has just said, we are very focused on generating that revenue growth, keeping the cost base really tight and driving to breakeven. And less reliant, as you might expect, in a market that's very difficult to operate in the days of having an ability to be able to go to the market with what we think is a very exciting valuable technology for the future, and raise capital is becoming more and more difficult. So in line with that, we want to become less and less reliant on it. So the breakeven profit process is uppermost in our minds. Okay. I think that's it. What I'll do is, Alex, is that okay with you? Or did you want to say anything? Or should we just hand over to the Q&A process?

Please do go ahead and answer the questions.

So, yes. We have several questions here. So if I kick off and Matthew and I will answer them. So Christopher has asked, given the FDA's protracted review process, how confident are you in gaining approval for CARDIO inCode score? And what impact would this approval have on your U.S. revenue forecast?

Okay. So the first part of this is that it's been protracted, not just over the last 3, 6, 12 months, but it's been protracted over the last couple of years. And just to dwell a little bit on this, the FDA have a liability for approvals they make. In this instance, we're talking about a De Novo classification for a test that gives an insight prediction around an individual's likelihood of heart disease in the future, entirely appropriate around their heritage, their familial risk in genetic terms and crucial in terms of moving the needle for risk assessment and prevention of heart disease. So we presented this to the FDA a couple of years ago. It came through a breakthrough process, which was then the breakthrough program was abandoned, so we had to then reposition it as a 510(k). When they look to the detail of that, they then said that, well, actually this was a really interesting product, but it was in its own regulatory class. And we're now in a De Novo program process. It has been protracted longer than I want it to be. But equally, as that's gone on, we've gathered in more and more evidence, strengthened our position and move them through the process as we've gone together. So we work very closely with them. How confident am I? Well, I'm at the other heart of it, and I'm working pretty much with them on everything we do. I can see that they've moved. We finished substantive review, and we're now into additional information. We've still got a lot of work to do on the additional information piece, but I'm confident that we can provide it. There is no one else who has the evidence base we have. Perhaps no one else who has the clinical advisory groups that we have, and that includes Presidents of the ACC, ASPC and the luminaries across the U.S., who make and have an influence over guideline changes in cardiovascular disease. And we have an evidence base from Kaiser Permanente that's unrivaled. So am I confident? Well, I'm trying not to be in any way complacent. We have to make sure we deliver, but I've got to be confident about where we are. But recognizing that it's a De Novo program with the FDA in an area that they know it will move the needle for risk assessment. It will identify more people who are at risk of heart disease, and that will make a big dent on health care changes in the U.S.. So they're very carefully thinking through all of that. It will -- and not only for the U.S., it will be global in terms of its impact. So that was the first part. What was the second part of the question?

I can probably answer that. What impact would this approval have on your U.S. revenue forecast? The answer is 0, because -- the only numbers in the market are Chris' numbers and he's only forecasting 2024 numbers at this stage. And there is 0 revenue in there for FDA approval. That's the main reason we haven't got 2025 numbers in the market and beyond, because it's -- it just changes the dial significantly. So we're going to have a good year in 2025 irrespective of FDA approval, but the 2 numbers are vastly different. So we'll work with Chris over the coming weeks, and we will have numbers out in the market 2025 in not-too-distant future.

Yes. And just to add to that, for what Paul said, this is important to recognize that the FDA approval is a medical -- the FDA approval is a medical device approval effectively a kit-based approach. Now at the moment, the way that we provide the test CARDIO inCode is as an LDT, lab developed test from our Irvine laboratory into the U.S. market. That will continue probably for the next 6 to 12 months at expanding and growing from the Irvine lab. The kit process, once it receives approval is quite a different approach, requiring distribution across the national states in the U.S.. We'll work that in quite a different way than the way we're currently selling our tests into the U.S. market. It will be a kit format, and that will be provided to labs so that they can do their own local testing. So it's certainly incremental. As Paul said, it will be additive to the way that with the work that we're doing at the moment with Chris and the team. But in the meantime, while we work for -- wait for approval, we are not losing sight of growing the company with what we have and developing what we're doing. But at the same time, obviously, it will accelerate massively once we get kit approval from the FDA.

Next question is, Spain remains your largest revenue region, but you have ambitious plans for expansion in Germany and other EU markets. What are the key challenges you foresee in scaling your products in these regions? And how do you plan to overcome them?

Well, I touched on this a little earlier because of the disparate nature by which each nation in Europe has its own regulatory thought processes is state health care systems and funding. It is -- it takes a lot of time, effort and resource for us to try and address that. We're not, is the answer. We're focused in Spain, Italy, Germany and primarily the U.K. in terms of if we include the U.K. and Europe. And those markets, we will continue to grow in and develop. There's still a lot of education required even in those core markets to expand what we're doing. But it's coming in line with, as I say, the guidelines that are starting to change. So we will be perhaps at this stage, partly because of the cost base, less inclined to move further afield into other new markets because it's just too cost intensive at a time when we're trying to grow revenue and keep the cost base tight. So yes, I mean I think hopefully, that answers that question.

I think so, yes. Next one is -- sorry, to read these questions, it moves the presentation. The setup is slightly different. So I'm going to move down -- just move you on to the financials, but I'm reading the questions here, which says also how large is the potential market for the ROCA test? What are your commercial goals for its deployment in the NHS and other EU markets?

Okay. So again, the thing that I want us to -- I like us to do, and I think we're very keen to make sure as we progress the work that we're doing with the NHS is ensure that the way we position it and implement it, and the NHS acts as a model for the way we then cross supply it internationally. So in terms of the U.K., at the moment, the estimates say that around about there are 10,000 women, which is the market for those who have been assessed for BRCA testing and not undertaking risk-reducing surgery. That's the core market to start with, but effectively, it's women who have taken the BRCA test have not gone ahead with risk-reducing surgery. In terms of pricing, the pricing for the product is going to be around about something in the order of would say, GBP 100 per test. Remember, this is not a genetic test. And we'll be looking to try and make in terms of margins, significant margin on the back of that process because it's a software-based approach. We're also looking at and thinking about the way in which cancer antigen as a test is gathered in and collected as part of the electronic medical records system in the NHS, because as it's a software program, this is a nice, neat digital application that could be applied to, for example, the NHS app. So there's other ways in which this could be approached. But for now, we're keen to make sure that we firmly drill home what we're doing with the NHS, and that will then become the model by which we export it to other nations.

And remember, that 10,000 target market, it's a monitoring test, not a genetic once-in-a-lifetime test. So women generally take it 3 times a year. So it's a recurring test and women can be on that test for up to 10 years or so. It's a large market.

Yes. And I think there is demand in the other markets coming. But again, to some extent at the expense of making sure we don't over resource this and put too much cost in. We want to get it right in the home markets. And here, certainly in the U.K., there's more -- there are more advanced certainly supported by the NICE recommendation. So we're going to get it right there and then think about cross application.

Peter asks, with a cash balance of GBP 2.92 million and recent fundraising efforts, how long do you expect this cash runway to last? And do you anticipate needing further capital raises in the near future?

So I mean, again, in some ways an obvious question was asked the question, who was it, who asked the question?

It was Peter.

Peter. Okay. Well, thanks, Peter. Yes, I mean, we said last year when we raised the GBP 4 million that we would be coming back to the market in about 12 months from now on the back of growth and development of the company, and that's where we are, and that's where we will be when we do come back to the market. However, at the same time, we're driving that top line, and I also want to make sure we get through the other pieces of growth that we can see in the short term, so that we're well placed if and when and the timing of that when we come back to the market but it is, for us. We are determined to drive the company forward at the revenue and then keep the cost base tight. Cash flow and runway, probably out to quarter 1 -- end of quarter 1 next year. But obviously, at the same time, we're starting to grow other areas. So I'm not suggesting that's going to massively impact it. But we are kind of very focused on that, but that's a rough outline of where we are in terms of runway and fund raise expectations.

Okay. And Philip asks, I live in Devon and want my wife to get a LIPID inCode test. How do I get one? How GP appears not to have heard of FH, which is probably worrying.

Yes. I mean that is worrying if they haven't heard of FH, I mean that's really quite concerning. I mean there is this -- we have become more aware of whilst the NHS policy, 10-year policy was to identify 25% of the population in England, NHS England with FH, that as we've looked more and more in detail of that, it's become more and more obvious that, that hasn't been the case, and they're way off that. Now I'm pleased that we're managing to get the North of England to meet their targets. That's the beginning of the process. But it sounds like there's a degree of education that needs to be undertaken in Devon with your physician maybe around the importance of FH, and what it means in terms of accelerated onset of heart disease. So coming back to that, we can -- we'll perhaps reach out if you can contact the company if it was Peter or Philip, rather, Philip, if you contact the company, then we'll arrange for someone to contact you and set up some form of arrangement. We may have to get you to talk through one of our contacts in Bristol. We're also talking with the Bristol Genetic Lab hub as well and see if we can't do something via that press. That's the nearest genetic lab hub in the NHS to you, and that would be the outreach process by which we work with them to get you the test done. So that -- I think it's a really good example of us trying to pull that through. And it would be helpful for us to just see how things are with Bristol. But I know that Bristol are doing FH testing. They're not doing maybe as much on the polygenic side as we are. But if we talk to you off-line, we can try and set something up with you.

Okay. We have time for another question. Andrew asks, how are your collaborations with pharmaceutical partners evolving? And what kind of revenue contribution do you expect from precision medicine collaborations in the near future?

I don't know in the near future, but in the future, let's start there. I mean, remember, there's a plethora of lipid-lowering medications on the market. Many more of the medications than there are abilities to identify those who need it, which is what we do. So the key areas we can see that as we grow, we become more and more important to those pharma groups where there are restricted health care budgets and that they have to find those individuals who need therapy treatment most. So the first part of your question is we will be working with those pharma groups. There are 3 or 4 of them who I would say are at the top tier table, all of them I've got some form of discussion going on with at the moment, 2 or 3 of them are key to where we're going. And not only in terms of existing products that they currently deal with but also their new line of therapy is coming. And that's where I think we come into a stronger position for us as a company because we're identifying that very personalized risk assessment piece at the genetic level for the individual patient for which those pharma companies need to work with us and identify as well. So that's the way the shape of things to come. And you'll see a bit more on that over the coming months as we bring more news to the market.

Matthew, Paul, thank you for addressing all those questions that came in from investors today. And of course, the company can review all questions submitted today, and publish responses where it's appropriate to do so. But before redirecting investors to provide you with their feedback, which I know is particularly important to the company, Matthew, could I please ask you for a few closing comments?

Thanks, Alex, and thanks to everyone who dialed in today. I know everyone's really busy. But we try and make sure that we get the message across, whether it's Philip in Devon explaining about you can't get access to testing, all of these things in terms of making people aware that heart disease can be tackled with effective drug treatment, but we have to find the individuals who is most at risk. So that's what we're doing. So we're thankful for everybody attending the call. Please let us know if there's anything else that you need or you're not familiar with what we're doing as a company. We'll try as best we can to answer that through our financial communications group, Walbrook, and the rest of the team here at Cavendish. But thanks, everyone. And yes, please let us know if you need anything further.

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