Genincode (LSE:GENI) — Interim results presentation

0:00 Good afternoon, and welcome to the GENINCODE PLC Interim Results Investor Presentation. Screen. Simply type in your questions and press send. 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, which is 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 Fulgier, CFO at the Cavendish broker offices in London, Central London for those of you who know roughly where we are. We've got quite a bit to get through, so I'm gonna move at some pace through the presentation.

0:59 We'll start with a brief introduction then move through the results, take a look at The US strategy, EU and UK, 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. We have an established business, which was started back in 2007 with Ferro Pharmaceuticals. And then in 2018, we spun out those two businesses to form GENINCODE.

1:47 Globally leading evidence based, so significant. And over the last twelve months, we 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 a one product company. We have several. And the main focus of 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 US, UK and Europe.

2:38 Accounts for roughly a third of mortality. A significant economic burden to society and mankind. 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. 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 US commercial sales for lipid encode and cardio encode 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 the main submission, the de novo submission.

3:36 It's taken the best part of six 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 encode. And when I say we, that's mainly our partners Kaiser Kaiser Permanente in The US. We put out our first major publications earlier this year. And then subsequently we've presented more recently at the European Society of Cardiology around self reporting and also high levels of IDL, LDL alongside polygenic risk score. We'll touch on that as well in a few more slides.

4:37 US 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 US, the lobbying group for use of testing for familial hypercholesterolemia and LP. We received notice of allowance, so that's patent for cardio encode. We're expanding in the NHS with lipid encode. So we started last year in Newcastle. That's now drifted down to Leeds and Sheffield. So we've seen a a pickup in volume there, which we're pleased about. And also on top of that, we're we're now looking at extending that into the Northwest 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.

5:29 We're seeing growth in Germany too, so really pleased about that. And good solid positioning in Spain and Italy, they too have had a good first half. And also the pilot's progressing well in Spain, Extramadura, we have other regions now coming into focus there as well. So we should see further expansion of CardiCODE 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 placings in the main market or rather 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 what we're doing as a group over the past twelve 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.

6:33 Okay. Moving on. That's the product setup so you can see the glance where we are. Europe has most of the product regulator approved, and our main market in Spain sells most of those products. As we come across into The UK, it's mainly lipid encode and cardio encode and again into The US lipid encode and cardio encode 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. Relatively straightforward process. But to do that, we use our own online system. It's called Citab, and we don't often talk about it, but it's an important backbone of the operation.

7:27 And it's growing significantly now, only in Europe and The UK as we've moved that, but also now into The US. 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 to explain that. It handles everything from ordering through processing and increasingly as our volume is build it's becoming more and more important to us that we align it with the local market position through processing into the risk scoring. The algorithms risk score the position for the patient samples, and then we report that back to the physician. And that that process and that system is all part of our onboarding as we grow a volume across the company.

8:18 So the same process and the standards are applied and that 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 we do things across the company. It's a really important piece, a backbone that's not often seen, but I think it's worthy of bringing further attention to our investors. Okay, so it's moving back to The US. This is the market, a significant market in terms of cardiovascular burden. Around eighty six million Americans suffering with cardiovascular disease. It accounts for nearly third of all mortality in The US, a 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.

9:07 This is where we're rolling out. So I I'll I'll continue to to show 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 US. Those areas in yellow or those groups, institutions in yellow are the ones that are onboarding or have onboarded. 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 sit down 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 US because groups 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 US.

10:22 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 groups now starting to pick up and gain interest and order from us is also growing now. That's going to be I think the state, perhaps the biggest state for us in terms of growth certainly over the short medium term. So the the sales and the business has started now to grow in The US, so we're we're excited by that and also excited by the partners we're working with. These are the main key opinion leader influencer sites across The US. And also I'm pleased to say that a lot of these sites, the individuals who work with us and they're part of our publications and have authored them are also part of this too. So it's a good network, good community to build within.

11:11 And this is just a summary of where we are for each of the for cardio and lipid. I'll 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 they aren't really available. This it's not a product class that is 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.

12:03 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 US revenues coming through. Not significant, but significant in terms of the fact that it's 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 are set up, so we're 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.

12:59 Reimbursement. Paul, I think you're just moving the slides. There we go. Let's go back. So oh, no. No. We're not. No. We're not. Let's just go there. Okay. So coding wise, we have coding for cardio encoder four zero one u. We also have our pricing. It's between 500 and 700 and $60 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 gonna 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 CardioEncode for Medicare from in 2025.

13:48 That's going into the schedule. When we get through the FDA process, we will also be submitting our MolDX process for Cardio and Co. That will allow us to gain Medicare coverage. So in the first incident 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 setup implementation. On the commercial payer process, we've started discussions and we've now been recognized as an out of network payer provider.

14:34 And as I mentioned, we provide the testing on a service based approach to healthcare institutions, clinics, and also executive health is becoming a big feature for what we're doing. So this is the 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 fourteen years on just over 63,000 patients, And it went to show that genetic risks are an independent risk factor, independent of clinical risks. So for example, smoking, physical activity, eating habits, and so on. So totally independent.

15:24 The the study showed that over that period, cardio encode was consistent in its ability to identify risk across sectors of 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 higher 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 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.

16:14 We've then subsequently in the last twelve months provided four or three of the studies to make four in total in and around different aspects of using cardio ENCODE at a population level for polygenic risk assessment. The main publication that went out 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 also 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, KARDION CODE provides a much more accurate risk assessment of an answer to that question.

17:01 So we're looking now at the familial risk of an individual for heart disease. The other thing that's happening and this is coming quickly and we're very pleased to see that the American Heart Association issued a policy statement around the use of polygenic risk scoring recommending that where physicians see that a patient is at intermediate or borderline risk so they're uncertain of the risk of the patient at that point clinically, then they should refer to coronary artery disease polygenic risk scores as a 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.

17:51 Again moving physicians into a mindset that genetic risk is an important factor to be taken into consideration alongside clinical risk. And 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 just to explain to you how this then is implemented clinically. This is the primary prevention standard of care guidelines for the way a physician assesses the risk of a patient for heart disease.

18:41 And it's factored into clinical risk functions and equations. There are different equations across Europe and The US, but they all typically work around a ten year risk assessment horizon. And those individuals who are at low risk are below five percent probability of an event over the next ten years. Those are borderline intermediate between five to seven and a half or seven and a half to twenty percent, and those above twenty percent are high risk of an event. Now they're all based on clinical risk factors and with the advent now of 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.

19:55 If the patient has an intermediate genetic risk and an intermediate borderline intermediate clinical risk, then the patient needs to be advised that they have an intermediate risk and the 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.

20:47 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'll be the way in which the genetic risk scores are implemented in terms of the systems both Europe, UK and in The US. And we expect to see the SC 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 are in some ways when we did this estimate of the market for The US, it was when physicians 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.

21:51 And when we did this market exercise a couple of years ago, we identified twenty one million patients who were at what were currently classified clinically as low or intermediate risk. And of those when we asked them if they would prescribe a risk assessment tool, a polygenic risk tool to their patients, about eight point five 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, 100 to $760.

22:36 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, you know, strong significant margins from the cardio business as it grows, especially in The US. And this is then a summary of where we are at the regulatory level as well as at 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 and code over until we go through to insurance cover and Medicare cover will be at that $400 mark.

23:25 Regulatory, well, as I mentioned, as we move towards the end of this year around quarter four, we expect to get an update and a discussion around whether we have approval or maybe update the market around quarter four of this year. We're ClearCap 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 CardioEncode 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. Moving across to lipid encode. So lipid encode is the main revenue generating product for us. So it received tier one 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 been recognized by the CDC in The US.

24:31 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 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 the monogenic side, there's recognizer about one in two hundred, one in two fifty 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.

25:25 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. The market is likely to expand. And the other point just to note on identifying these patients. At the moment, whilst there are one point six million estimated patients who suffer with FH, The number of tests that are currently undertaking 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 the group who lobby for awareness of FH and LP, but also the partnership with the other groups that I've highlighted there on the in the fourth paragraph.

26:29 This is the beginning of a very strong partnership arrangement with these groups. They're not only collaborating with us to to roll out the program at their primary care level for FH and LPA detection, but these groups are also starting to independently of of this program buy from us on a system by system basis too. So very pleased about the the work that we're doing with them. It complements everything we're doing in The UK and in Europe. So a really solid position and also is underpinned by what I started with was the Sytab system. The Sytab system is also part of the process by which we'll then lead these products and testing into The US market. I mentioned it's $1,200.

27:17 That's a combination of those four gene areas that we 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 out about $1,200 for a test for insurance payment. And in this instance, we've got green on all of these. So this is this is why we're pushing and moving the product as swiftly as we can into The US 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 we also cover that here in The UK and we're looking now to introduce that into The US and also statin intolerance and at the same time the guidelines and the increase of the recognition of the product to tier one status for public health.

28:18 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 when you're now moving across onto the West Coast, That's the Northwest 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 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, you know, the the low cost in which we're providing it to the NHS. So this is a arguably a no brainer for 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 it, as I mentioned earlier, it truly is a personalized medicine, precision medicine approach.

29:27 So that's where we are in terms of the North Of England, we have the Northwest coming on and in combination with our pharma partner friends, we're looking at then further use of their not only existing lipid lowering medications, 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. You know, good solid performance in thrombo and lipid encode. Lipid encode, 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 are they growing strongly, doing, you know, a solid job, but at at the same time, we have the new regions, Extremadura is where we start with cardio encode, but we have other regions now coming on for cardio encode pilot testing as well. So Andalusia, Catalonia is now planned Basque region and also Madrid.

30:35 A good collaborative positioning too, so that's been a part of the growth that we've seen over the last twelve, eighteen months, which has been solid for us in 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 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 it requires a lot of bandwidth and focus. So, you know, whereas for example, our bandwidth when applied in The US and certainly in terms of the FDA gives us a closer approach to a much bigger market opportunity.

31:31 So, whilst you the European market is valuable to us, we have to carefully align the amount of resource we expend on some of these markets because they are somewhat disparate by comparison with the bigger markets. Quick update on ROCA. Not we obviously received the 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 to get the recommendation there. And as a result of that, now we have six regions, two in London, two in the Mid Midlands, and two 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 on setting 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 is provided as a recommended test for surveillance so it can take the testing is undertaken two three times a year on an ongoing basis while the woman

33:01 is at risk of ovarian cancer. So we'll provide a further update over the coming months on on ROKA but good progress now coming through on the NHS and Switzerland we're just starting to prepare to take the first samples through from for the Swiss market as well. And we won't we won't be moving more broadly until we've anchored the NHS it was mainly the NHS before we then think about moving further field smoother markets, again, partly from a bandwidth perspective. Okay, I hand over to Paul. Thanks, Matthew. Good afternoon, everybody. On the financials, first half revenues up 46% to 1,400,000 Modest number still, but, you know, good solid growth, which we've enjoyed over the last couple of years. From a product perspective, Lipid Encode remains our biggest seller. That's more than doubled to £860,000.

33:59 That's followed by thrombo, which represents about £300,000. That's grown by more than 20%. And and then selling code, £200,000, and then cardio in fourth place. Just a reminder, you know, all four of those products, are CE Mark selling in Europe, selling selling in Europe and and all growing. In The UK, we've enjoyed good growth at £320,000 from The UK that compares with just over a £100,000 last year. So remember, we've had the full six month benefit of the NHS contract that we pulled in in, May 2023. And that's, that's solely selling lipid encode product. In Spain, Spain represents about a million pounds.

34:45 And when we say Spain, we refer to Spain, France, Italy, a couple of other countries there as well, but the the main geographic office as such we refer to as Spain. And then and then The US, £71,000 of revenues coming in there. So hopefully, all three of those regions will continue that growth for the rest of this year. From a margin perspective, margins have improved to 53%. The products 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 UK, which is now coming up fast is around 70% and The U. S. Is coming in at over 80%.

35:37 So that mix will continue into improve that gross profit margin percentage for the rest of the year as The U. K. And The U. S. Revenues do increase. Reduced operating losses. So our overheads have come down significantly over £1,000,000 So we've had reductions in salaries and that's mainly The U. S. Levels there. So levers we're replacing on lower salaries and working differently with the staffing levels we have over there. Consultancy fees and legal professional fees have come down about £500,000 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.

36:25 When we set up partnership with our revenue cycle manager in The US last year, we spent about £150,000 on setup fees that's non recurring. We're paying them a variable cost in portions of revenues this year, so a continued savings there and development costs, things like FDA submission costs at the end of last year, they're non repeatable costs. So we should continue to see those savings in the remaining six months of this year as well, which leads to a much reduced adjusted EBITDA line of $2,200,000 versus $3,400,000 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 that we're talking twelve to eighteen months still there, but very much improving numbers and we see that continuing very much into the short to medium term there. Cash balances £2,900,000 at the end of June twenty four.

37:33 Got a cash runway of about £400,000 a month and we've completed that, that's net of that fundraise that we completed in January 24. Back to you, Matthew. Thanks, Paul. Okay. So just starting to 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, should hear the clinical lab fee schedule pricing for 25. Hopefully, it'll be a bit 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 that 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 what the how the discussions will fare on the additional information, but we're certainly well on with that and in discussions with them over the coming months to finalize.

39:03 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 Cardiogenomics Conference at the ESC towards the end of this year again presenting on cardio encode 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 Encode that is. And in the meantime, just to reiterate, it's a self pay process for cardio and code whilst we don't have any insurance coverage. And that's pretty much it. The only other pieces then are updates and and expansion beyond there. Increasingly, the business is now all about building, scaling, growing, and selling.

39:49 There's less in terms of development, less in terms of regulatory approval. And then just to wrap up there, so we we it's all around expansion cardio, driving through the FDA process, expanding the NHS program and in Germany too. Also the the new pilot programs that are coming on in Spain, Catalonia, Basque Region, Madrid, and Andalusia. Then starting to see some traction from from the NHS around Roka. 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, you know, the 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 I think in line with that, we want to become less and less reliant on it.

40:50 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 did you want to say anything, or should we just hand over to the q and a process? Please do go ahead and answer the questions. Can you guys Thank you. Yeah. We have several questions here. So if I kick off on, 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 ENCODE score, And what impact would this approval have on your US revenue forecast? Okay. So so the first part of this is that it's been protracted not just over the last three, six, twelve months, but it's been protected over the last couple of years.

41:40 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 five ten k. When they looked at 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.

42:37 It has been protected longer than I wanted it to be, But equally as that's gone on, we've gathered in more and more evidence, strengthened our position, and moved them through the process as we've gone together. So we work very closely with them. How confident am I? Well, you know, 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 US who make and have an influence over guideline changes in cardiovascular disease. And we have an evidence base from Kaiser Permanente that's unrivaled.

43:29 So am I confident? Well, I'm I'm trying not to be, you know, in any way complacent. We have to make sure we 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 US. So they're very carefully thinking through all of that. It will not only for the for The US, 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 disapproval have on your US revenue forecasts? The answer is is zero because the only numbers in the market are Chris' numbers, and he's only forecasting twenty twenty four numbers at this stage.

44:20 And there is zero revenue in there for FDA approval. That's the main reason we haven't got twenty twenty five numbers in the market and beyond, because it's, you know, it just changes the dial significantly. So we're going to have a good year in 2025 irrespective of FDA approval, but the two numbers are vastly different. So we'll work with Chris over the coming weeks and we will have numbers out in the market for 2025 in not too distant future. Yeah, 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.

45:10 Now at the moment the way that we provide the test, KARDION CODE, is as an LDT, lab developed test from our Irvine Laboratory into The US market. That will continue probably for the next six to twelve months expanding and growing from the Irvine Lab. The kit process once it receives a pro approval is quite a different approach requiring distribution across the the the national, you know, states in The US. We'll work that in a quite a different way than the way we're currently selling our tests into The US 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 a wait for approval, we are not losing sight of growing the company with what we have and developing what we're doing.

46:04 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 the desperate nature by which each nation in Europe has its own regulatory thought processes, state health care systems, and funding. It is it takes a lot of 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 UK in terms of if we include The UK and Europe.

46:56 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 yeah. I mean, I think hopefully that answers, you know, that that question. I think so. Yeah. Next one is sorry. To read these questions, it moves the presentation. So the setup is slightly different. So I'm going to move down, which moves you onto the financials. But I'm reading the questions here, which says, also how large is the potential market for the VOCA test?

47:47 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 do, like us to do and I think we're very keen to make sure as we progress the work that we're doing at the NHS is ensure that the way we position it and implement it in the NHS acts as a model for the way we then cross apply it internationally. So in terms of The UK 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 bracket testing and not undertaken risk reducing surgery. That's the the core market to start with but effectively it's women who have taken the bracket test have not gone ahead with risk reducing surgery.

48:35 In terms of pricing, the pricing for the product is going to be around about something in the order of, let's say, £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 record 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 there's other ways in which this could be approached. But for now we're keen to make sure that we we, you know, 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.

49:27 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 three times a year. So it's a recurring test and, you know, women can be on that test for up to ten years or so. Yeah. It's a large market. Yeah. And I think there is there is demand in the other markets coming, but again, at the to some extent at the expense of making sure we don't over resource this and put too much cost in, we wanna get it right in the home markets. And here, certainly in The UK, there's more there are more advanced certainly supported by the the NICE recommendation. So we're gonna get it right there and then think about cross application. Peter asks, with a cash balance of 2,920,000 and recent fundraising efforts, how long do you expect this cash cash runway to last? And do you anticipate needing further capital raises in the near future?

50:25 So I mean, again, it's in some ways an obvious question because it who was it? Who asked the question? Who was it? This was Peter. Peter. Okay. Well, thanks, Peter. Yeah. I mean, we said last year when we raised the 4,000,000 that we would be coming back to the market in about twelve months from now on the back of growth 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, you know, we we we are determined to drive the company forward at the revenue end and keep the cost base tight.

51:11 Cash flow and runway probably out to quarter one, end of quarter one next year. But obviously, at the same time, we're starting to, you know, grow other areas. So I'm not suggesting that's gonna massively impact it, but we are kind of, you know, very focused on that. But that's a rough outline of where we are in terms of runway and fundraise expectations. Okay. And Philip asks, I live in Devon and want my wife to get a lipid encode test. How do I get one? How GP appears not to have heard of FH, which is probably worrying. Yeah. I mean, that is worrying. If they haven't heard of FH, I mean, that that's really quite concerning. I mean, there is this we have we have become more aware of whilst the NHS policy ten year policy was to identify twenty five percent of the population in the in England, NHS England, with FH that that as we've looked more and more in detail at 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, so it's the beginning of the process. But it sounds like there's a degree of education that needs to be undertaken in in Devon with 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 we can we'll perhaps reach out if you can contact the company, if it was Peter or Philip. Philip rather.

52:39 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 the Bristol Genetic Lab Hub as well and see if we can't do something via via that process. That's the nearest genetic lab hub in the NHS to you and that would be the reach out outreach process by which we'd work with them to get you the test done. So 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 offline, we can try and set something up with you. Okay. Before we have time for another question, Andrew asks, how are your collaborations with pharmaceutical partners evolving?

53:31 And what kind of revenue contribution do you expect from precision medicine collaborations in the near future? I don't mind in the near future, but in the future, let's start there. 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 here is we can see that as we grow, we become more and more important to those pharma groups where there are restricted healthcare budgets and that they have to find those individuals who need therapy treatment most. So so the first part of your question is we will be working with those pharma groups. There are three or four 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, two or three 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 therapies 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 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 as we bring more news to the market.

54:58 That's great. Probably it. Okay. 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 is appropriate to do so. But before we direct our 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 who dialed in today. I know everyone's really busy, but we try and make sure that we get the message across, you know, whether it's Philip and 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 are 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 with what we're doing as a company.

55:50 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, yeah, 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 and 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.