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

Good afternoon, and welcome to the GENinCode plc full year results investor presentation. [Operator Instructions] Before we begin, I'd like you to meet the Foulger, Paul. But I'd now like to hand it over to Matthew Walls, CEO. Good afternoon, sir.

Good afternoon, Alessandro, and good afternoon, everyone. Welcome to the 2023 Final results and business update. I'm here at the Cavendish broker offices in the center of London with Paul Foulger, our CFO and we're going to walk through the results presentation from 2023. I decided that it would be worthwhile moving with a little bit of pace. We've got a lot to cover. And for those of you who've had a chance to read yesterday's RNS, there's quite a bit to get through. So I'm going to move a little bit quicker through today's presentation so that towards the end, do we have a bit more time for Q&A. But in any event, we'll cover off the headlines and the key points. So moving on, I'll also move through some of these slides a little bit faster than I would normally. But just as a headline, we are a predictive genetics Bioinformatics company, we have a high amount of structured algorithms in the background around the way we calculate and risk score cardiovascular disease. And we're now obviously taking our products to market in Europe, the U.K. and the U.S. And the rest of this presentation brings everyone up to speed as to where we are in that program. So I'm now going to move to Slide 5. This is a summary of what was presented yesterday in the RNS, but important that we start here and then we'll progress into what the outlook over the rest of the year and beyond looks like. So year-on-year revenues are up significantly, GBP 2.2 million, mainly in the growth from the U.K. and Europe. So good years from both of those regions. We also, last year, started our early access programs in the U.S. for FH. That's Lipid inCode and Cardio inCode as well. So both of those Products are now starting to come on stream in the U.S. The de novo submission to the FDA, where we went originally with the 510(k), the FDA asked us to move across from the 510(k) to de novo. And importantly, that puts us at the forefront of change in this area. So this is a new regulatory class. And I'm pleased to say that we're making good progress with them as well. I'll come back to that in more detail as we go through. NHS also clinically adopted Lipid inCode in the north of England, and that's now starting to expand. We'll touch on that. Germany too, we started the clinical adoption of Lipid inCode there. So our first sales coming through there, too. Good growth in Spain, as I mentioned. We finished the year on GBP 2.5 million of cash, good investment in preparation for starting up sales in the U.S. And then we finished the year and started with a second replacing. The intention of the company is to raise what it needs as it requires it, but at the same time to make significant growth on the back of that investment we raised. I'm pleased to say that the first sales have now started in the U.S. market. So moving from early access, we're into commercial programs. I've just cited a few. We'll look at a few more. But importantly, they're big, bigger groups, so I've mentioned them. You'll see in a moment some of the other groups that we're starting to work with as well. Also some big publications at the American Journal of Preventive Cardiology, Kaiser presented their papers to that, and we'll talk about the importance of that publication for us as well. We received patent granting or notice of allowance, as it's called for Cardio inCode. We also received nice approval for our new ovarian cancer risk assessment test, that's the ROCA test. So very pleased about that. And also, we've got some early licenses coming through from Switzerland and Austria. And so far, year-to-date, we're 37% up on the same time last year. So again, strengthening the growth position of the company as we move forward. Okay. Next slide is a summary of where we are on a product base. Not a lot of difference here in terms of the rollout, things moving. We've added now ROCA into this. So there's now a fifth stream of revenue starting. So we've not only got the international expansion, but also now an additional product in the portfolio. So I've added that in. I won't go through this, but this is the process that we -- well, I won't go through it in detail, but this is the process by which we collect samples, transport them through to the lab. They go through molecular processing. That's the identification of the DNA and the variance within the DNA of the individual. And from that, we then risk score and provide the results online to the physician. It's worthwhile saying that the systems that we have to do this is significant. They're global systems. They're harmonized at what we do in the Europe, in the U.K. and the U.S., it's harmonized. That's important from the point of view of risk scoring and AI, the way we produce those reports is done consistently. And it also means that as we move forward in polygenic and multiple gene analysis, we have a system that is very competitive in this space. So very pleased. It's taken a lot of time over the last 10 to 15 years. For those of you who are familiar with the company as it's grown, to put this system in place. The U.S. market, it's still incredibly significant for us, and this is where I'm certainly spending most of my time and effort. So around 86 million suffering with cardiovascular disease. It accounts for the main area of mortality. Certainly, the biggest area of cost as well, not only in terms of health care spend but also in terms of impact to the economy. And it's growing, and it's significant. There was a [indiscernible] of paper, I think it was released just in the last week or 2, again showing that cardiovascular disease is globally the biggest killer on earth. And at the same time, even during the COVID years, it was higher than COVID. So it gives some indication as to what we're dealing with in terms of the importance of recognizing genetics in prediction of cardiovascular disease. Summary of the U.S., and then I'll skip through some of the other areas. We've started the commercial onboarding program, and I'll go through a bit more detail of that in a moment. The core products for the U.S. are Lipid inCode, which has reimbursement and hence, we're leading with that. And that will be where most of the revenues come from for this year in the U.S. Cardio inCode a little bit behind it in terms of reimbursement, but again, moving quite quickly. Our first revenues have now started in the U.S. And again, for those of you who are familiar, we set up last year the regulatory pieces around the laboratory in Irvine and also a de novo submission for Cardio inCode through the FDA. Again, just to reiterate, good progress with the FDA. There's been a lot of work they've undertaken recently with Kaiser around information and access to the real-world data that Kaiser have. Again, for those of you who are familiar with what we're doing, we've worked Cardio inCode over 14 years. We followed just over 60,000 patients. So this is a population-based study. And what that study goes to show is the importance of genetics and risk assessment for cardiovascular disease. We'll touch on that in a moment again. Reimbursement, we now are coding. We've agreed pricing. Still a little bit of work on the pricing, but it's agreed at a price point that we think is increasingly getting right and fair. I'm still in discussions, but it's pretty much agreed and the importance of that is reimbursement, which would then be covered by Medicare. Reimbursement, for those of you who are not familiar with this, is an important piece of establishing a revenue base in the U.S. and a value, which is from a -- both a Medicare and private insurance coverage perspective, a cornerstone that we use for driving the value as we move forward. And the other piece that's linked to that is a MolDX submission. And that's in preparation. But once we've agreed the final pricing, we'll submit that. There will be probably later this year, the MolDX piece. Commercial operations, in terms of that, it's mainly around meeting with the key opinion leaders, educating, advising them, sharing with them the information, the new data that we now have, that's begun to start being published and working with them to integrate our technology and products with their health care systems. Also, at the same time, commercial payer discussions. This is with the insurance companies who provide the health coverage for patients in the U.S. health care system. And then finally, the publications have started, and there'll be a few more of these coming in the next -- probably next few months. We've got Kaiser presenting here in London at the annual ESC conference, they've got an oral presentation. And I'll talk through now, it is a little bit of background in a moment on some of those publications that are coming. They're the core partners we work with. So Indiana, Kaiser, MedStar and New York Presbyterian. They've been at the forefront of us leading with clinical validation, clinical utility around the products as we move them into the U.S. market. And this is the slide I showed about 6 months ago around the Early Access Program. And at that time, most of these groups were colored white. They're now increasingly becoming yellow. Hopefully, that's a little bit easier to see, but the yellow ones are either onboarding or in the vast majority of cases starting to now order testing from us. So people like Indiana, Johns Hopkins, MedStar, Atrium, UT Southwestern, UCI Health on the West Coast and San Diego have all started to order more recently, [ Emery ] and who else is in the St Elizabeth; they're just onboarding at the moment. My intention, our intention as a company is to drive the further growth and implementation of the products through these health care systems. They each sit in communities at a state-based level. So that will cascade into that broader community coverage. And then on top of that, we'll also be looking at executive health and concierge medicine as well where they tend to pay a bit of a higher price for the products we take into market. So the commercial program has started in the U.S. This is a little bit of background on the publication that was made about 6 to 8 weeks ago, a very important publication for us and also for the health care industry. It's the first major population study, which shows the importance of polygenic risk scores for identification, prediction of heart disease. And it showed that Cardio inCode score, that's our product, which we talked about, it has recently received patent approval is independent of other risk measures, clinical risk measures. That means in its own right, it's an adjunct to clinical risk assessment. It was consistent across male and female individuals consistent in terms of its application to both male and female and also across ethnicities as well. It allows the risk stratification of individuals in the population. That's vital. So it starts them to, on a genetic basis, identify those individuals who are at most risk of heart disease. And also we'll -- by doing that, those who are most likely and perhaps should be receiving statin and onboarding of therapy. And back to the independent point, it works well and in alongside traditional clinical risk factors. So the polygenic risk score, what it's going to be and it's starting to become and there's still a lot of education required when we're talking with the physicians, it will become an important -- it will move the needle in cardiovascular disease. So that on a lifetime risk basis, individuals become aware of their polygenic risk for coronary artery disease. It's somewhat similar to the same process that in the last 10 to 15 years has been adopted for BRCA and Lynch syndrome, where the genetic test gives -- identifies the risk of the woman in the case of BRCA for breast and ovarian cancer. And then at a point in the future, the likelihood is based on that risk, she may or may not have a future issue with breast or ovarian or the need for risk-reducing surgery. In the same way with coronary artery disease, it gives an indication of the lifetime risk of that individual, especially for those who have a high polygenic risk score. So it's a necessary step, a necessary move to improve the standard of care for cardiovascular disease. The market hasn't changed. It's a significant market based on -- we've actually narrowed it. So those that we can see at the moment, we'll need it most, and they fall into what we call low risk or intermediate risk of cardiovascular disease, and they're measured in terms of low risk or intermediate risk on their clinical risk assessment, not on their genetic risk. As we bring the genetics alongside that, a high number of those low risk and intermediate individuals who were then found to be at high genetic risk will be reclassified into a much more focused therapy and treatment. So at the moment, within that 21 million, there are individuals who have a high genetic risk, but we don't see them. We're not aware of where they are. So when we ask physicians about the use of the technology moving forward, they said they would -- around 8.5 million of those patients they would prescribe if there were a product available that could identify the genetic risk. So these market figures haven't changed. In fact, we recognize at the moment that they're likely to be increasing simply because physicians are becoming more aware of the value and the importance of polygenic risk. The pricing, I mentioned a little earlier it's going to end up somewhere in the region of $500 to $760. The CMS have proposed $500. We did discuss last year, and we had an approval at that point from them that it was near $760. They've come back and asked for a slightly reduced figure. So I'm still finalizing that with them, but we expect it to be agreed between those prices, both of which will be, I think, reasonable for us in terms of rollout as we move the product forward. They're both attractive in terms of margin and value as we drive volume through the U.S. market. And the reason why, again it's getting more exciting. There was also a significant statement by the American Heart Association about polygenic risks. So this was published last year. And the importance was that they were now citing polygenic risk should be starting to be taken into consideration alongside clinical risk parameters. When the standard of care changes, we're at the forefront of that in terms of our product positioning. There are very few, if any, at the moment, given our FDA de novo position, there was no one in this space. We will be the first to market with a clinically approved adoptable regulatory-approved product in the U.S. once the guidelines change to incorporate polygenic risk, that's a strong competitive position for us. And this is a summary. Actually, it seems a fairly busy slide. So what I did was on the bottom left-hand corner was made it a little easier to interpret. But you have the time line for regulatory at the top and then below that, the box of the reimbursement pathway for Cardio. But in summary, we're well advanced now with the pricing, as I've just discussed with the CMS. Reimbursement, well, once we've just finalized the pricing, we'll submit our MolDx submission. But at the moment, we have a cash pay arrangement out of pocket. On the regulatory side, you know about the FDA approval and the fact that we're in the de novo position. And then in the meantime, we're selling our lab developed tests through the pricing to the U.S. Evidence base, as I mentioned, is very strong. And I think as a group, I don't know anybody is putting out the level of population-based data together with the strength of evidence that we are and guidelines, as I said, they're starting to change the statement by the American Heart Association very much in our favor. So some done, some on the way in terms of [indiscernible], and I've just summarized them in that way. I think it's a little easier to pick that up from this slide. Otherwise, it feels a little busy. So moving across the Lipid inCode. This is the product that will generate most of our revenue this year, and we'll see growth in the U.S. coming from this. And the reason partly because it's reimbursed, it's got good pricing. It's already established as a test in the U.S. market and is escalating in terms of importance. So the CDC have lifted this to a Tier 1 status. There are only 3 genetic products at a Tier 1 status, BRCA, which you'll be familiar with, for women's breast and ovarian cancer. Lynch syndrome for, again, for oncology. And then finally, what's called familial hypercholesterolemia FH. And that's what Lipid inCode analyzes and presents back. So that is the accelerated onset of arthrosclerosis is what FH is. It's an inability to metabolize cholesterol effectively, which means it circulates at a high level in the blood, giving rise to air blocking, clogging, buildup of plaque in the arteries. So not a good thing and an accelerated onset of heart disease. So that's where we come in. We've got globally the leading test in this space. It's not only cost effective, it's a very broad test, and we're at the forefront of varying classification. We do a lot of testing in Europe and increasingly here in the U.K., as I'll walk through in a moment. And now we're starting to, has it adopted in the U.S. Smaller market than Cardio inCode, but a small and growing market as people become more aware of the importance not only of what we call the monogenic risk, which is this 1.5 million, but increasingly, the polygenic risk in the population as well. And again, polygenic risk is only becoming more aware because we now have technology that can measure this and see those individuals at higher risk. So an important step for us not only to be able to command this market, but to see the market growing as well. Much higher in terms of reimbursement here versus Cardio inCode. So it's on average about $1,200, the price for FH test. Now as the volume grows, I expect to see that reduce some, but still it's a significant value opportunity for us as a company. And if we can lay claim to not only the strongest product in the space, but then start to take market share, then that's where we want to be. And it's very much the same process here in the U.K. The other piece that's becoming a bigger feature of what we do is the -- what we call benefits investigation and prior authorization. So when a patient is referred for testing, we have to check their insurance, health care background, make sure that they've got coverage in place. So that means we're working with the likes of Aetna, Blue Cross Blue Shield, United Healthcare, Medicare and so on. These are the biggest providers of health care in the U.S. And we work with them in the initial stages because they won't have seen GENinCode before in what's called out of network. As we build a profile with them and we do more testing under their umbrella, then we move to what we call In-network, and that then requires further negotiation with them around volume benefits and things like that. I'm pleased to say we're into that process. Not big numbers, but significant for us at the start. We started this process and it's a very, again, complex but very valuable process as we drive insurance claims through the U.S. market. Again, much easier in summary here for regulatory because the regulatory position is in place. So it's more around clinical adoption and growth. And as you can see in the bottom left-hand corner there, pricing is there, reimbursement, regulatory evidence base growing too. We do most testing globally, I think, in this area and guidelines are in our favor too. So hopefully, now a strong following wind as we start to grow the product through the U.S. market. Moving over to the U.K. This is the NHS summary. So for those of you who followed the company last year, we introduced the FH Lipid inCode test to the North of England. I'm pleased to say that, that's grown. So from starting in Newcastle, it's moved then down through to Leeds and Sheffield. So North of England is very much the North of England. I'm also pleased to say it's moving through the Northwest. We have discussions also going on a little bit in the Midlands and also with UCL partner here in London, slower and for lots of reasons with the NHS. But nevertheless, what we have is a product that is more cost effective than it's currently delivered in the NHS, much more comprehensive and effective globally, like I've said, and our turnaround time is 10 days, 12 days versus 3, 4, 5, 6 months, sometimes with the NHS. So we have a significantly superior product in all respects. So there's no reason why it shouldn't be taken up swiftly. The other important piece is that it will allow the NHS to focus on other areas of priority, which they are effective in and can deliver at. But in this instance, this happens to be one where we have a strong hand and it should be not only cost-effective with the NHS, but adding much greater clinical value when it's fully adopted. There are 15, what we call HSM health information networks in the NHS England. They are in their own right, each one of them has a value piece that they should bring with them. And our intention is to take them one by one. We started well in the north of England, and we look forward to bolting on the others. We'll give an update later in this year, but we do expect to see this coming in the short, medium term. Europe, good growth in 2023, and it's continued into 2024, mainly through. And just to be clear, the Spanish market is much smaller than the U.K. and obviously, the U.S. market. But nevertheless, it's had a good growth in 2023. It's continued into 2024, both collaboratively. So collaboration is growing on the Spanish side. Also, Italy has come on stream stronger. And then finally, German, who joined the group, we saw good growth beginning of growth last year, and that's continued into 2024. A couple of slides on ROCA. So ROCA is our new test area, different from cardiovascular, this is Risk of Ovarian Cancer Algorithm. We liked it as a group because it was a simple digital algorithm in terms of adoption. And importantly, over the last 10 years, in the early years, it didn't have as much evidence base, but in the past few years, the evidence base has been significant for this product. It now leads the way in terms of evidence on a global basis. And that evidence together with the positioning of what we're doing with ROCA was put through to nice 12, 18 months ago. They reviewed the data, and I'll just draw your attention to that the evidence in the final box there related to accuracy and staging. Importantly, this product not only is effective at surveillance for women at risk of ovarian cancer, but it's incredibly cost effective as well. So it lends itself to adoption with the NHS. So we're very pleased about it. We received a nice approval. And then commercially, we're now starting -- we're in discussions with 4 to 6, 4, I would say, in earnest, in the NHS around implementation. We're also thinking about specialist commissioning and that would lend itself to being adopted in the NHS app. And then more recently, just after the announcement, Switzerland and Austria came through with interest on a license agreement, which we've now signed with them. So it's moving with a faster pace now on a commercial basis, too. So we're very pleased with progress for ROCA. Okay. I'll hand over to Paul, who give us an update on the finances.

Thanks, Matthew. So just to reiterate, this is the consolidated group financials. The full financials are at the back of the pack in the appendices. This is just a snapshot of the operations. We have the Spanish operations. We have the U.K. operations, and we have the U.S. operations. The U.K. now includes Abcodia, which we acquired, as you all know, at the back end of 2022. So full year revenue is up GBP 800,000 to GBP 2.2 million revenues. About half of that GBP 800,000 growth is an increase of 26% revenues in Spain. Spain, as you know, has enjoyed continued growth of between 20% and 25% per annum, and it looks like they'll be doing the same in 2024 as well. So a good backbone to the business. U.K. revenue has grown tenfold from about GBP 36,000 to GBP 360,000 in a year. And that's mainly because we've got the NHS contract, as Matthew mentioned, in May 23, and that's generating between GBP 50,000 and GBP 60,000 revenue per month. So this year, we're getting the full benefit. And if we get another region on board as well, the revenue would be even higher. So good solid growth in the U.K. And we're now starting to see the U.S. revenues coming in as well. So that will contribute to a strong 2024 finish for us too. Product-wise, Lipid inCode continues to be the biggest seller. So half of our revenue is generated by Lipid inCode. Remember that all the sales from the U.K. is Lipid inCode as well. So that's one of the major contributors to that product. And the rest is SUDD inCode, which represents about GBP 0.5 million of revenue from the Spanish office. Margins increased from 44% to 47%. Again, that's mainly due to the geographic mix, as I've always mentioned, Spain continues to be the toughest region of our target markets, between 45% and 50% margins. U.K. tends to be around 50% to 60%. So that blend of U.K. revenues has helped boost that margin to 47%. And when the U.S. revenues kick in, in earnest, that average should increase to 55%, 60% and beyond going forward. So I'd be expecting 2024 to be about 55% mark, so much healthier even more so this year. Losses increased from GBP 5.9 million to GBP 7.2 million. That's mainly due to the headcount increase. And as we mentioned at the interims, we've geared up the lab staff and the sales staff in anticipation of the kind of U.S. commercialization launch. So that's as expected. And then cash balances at the bottom. We ended the year at GBP 2.5 million. That's better than expected. We continue to drive the cash controllers as nicely as possible. And we've got a pretty low fixed cost base. So we try and manage that cash as best we can and only gave up the overheads as we are moving towards commercialization and not have staff sitting on the fence or other overheads, which we don't need to spend at that time. So around GBP 600,000, but that GBP 2.5 million related to the fund raise, which we completed in January. So GBP 4 million fund raise in January. So we're at about GBP 4 million at the end of March 24, run rate is about GBP 400,000 a month. So continue to look after the cash very nicely and a strong position there.

Wonderful. Thanks, Paul. And yes, I mean, just so that everyone is aware, we're particularly keen on making sure we keep a tight rein on all that. And with the -- if you look at the guidance at the moment for this year, they're estimating something in order of 4 with a revenue margin perhaps in the order of 2, which if you take that, reducing fixed cost of 6, it brings us significantly down in terms of expected losses at the end of this year. And that is the model that we're moving. We're moving to a breakeven-based target model, drive the top line growth of the company, keep the revenue at the margins of the company improving as we bring in the improving mix certainly from the U.S. side and moved the company into a different space and really do differentiate what we're doing amongst -- in the sector. It's particularly keen to -- we're particularly keen to make sure we take advantage of our position from where we are. Okay. So just to start to round up. I haven't put all of the big milestones here, most of it we've just touched on. But the big ones following the de novo process at the end of the last year that moved us across from 510(k) into de novo. Whilst there's still a month to run before I would expect to be to get confirmation from our friends at the FDA, it looks like it's going to take them longer. We're looking at quarter 3 at the moment. We've had good earnest, strong, good discussions, progressive discussions, as I said, with them. So we're currently anticipating regulatory approval around quarter 3. We've also got updates at the annual conference, as I mentioned around Cardio inCode from Kaiser Permanente. We also expect a number of updates from the NHS a little bit later this year, as I mentioned, around maybe expansion, ROCA and so on and also the finalization of the pricing for Cardio inCode. So that's some of the headlines. The other thing that's happening is there's an increasing number of collaborations below that, whether Indiana, Kaiser now complemented by Atrium and UC Irvine on the West Coast. So just to finalize, we expect this year to see significant year-on-year revenue growth with the expansion of Lipid inCode in the beginning of Cardio inCode in the U.S., we expect to see approval from the FDA, expansion in the NHS and in Germany and in the EU. And then based on the NICE guideline approval of ROCA, expansion on ROCA too. So the engine room in terms of revenue channels is moving quickly now. And so it should, we're very -- this is part of what we plan to do, and it's starting now to get traction. So we're pleased about that, whilst at the same time, keeping the cost base tight and turning the company into a very attractive opportunity for investment. So that's where we are. I'll pause there. That's the end of the presentation. And we'll move across to Q&A. Paul, have you got some?

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

Well, I mean that's quite some time ago. Was that 2016 '15 Yes. Well, well -- I would imagine it was back in 2015 when they even looked to the data. But in any event, 2016 some time ago, and it was well before the latest data that we've got from the ALDO study. So the ALDO study was a milestone -- the U.K. [ FOX ] study was the one before that. Both of them indicating that ALDO had an ability to see survey and see women at risk, but the ALDO study showing significantly that those women who had a BRCA, so genetic -- were at genetic risk for breast or ovarian cancer, that the evidence from ALDO shows that by surveying them using the ROCA test gives an early insight and early awareness of those women at increasing risk. I mean, I won't go into too much detail here, but it's the CA-125 antigen, the antigen that we look at and the algorithms that we use for this are now well proven, and that was what was submitted as part of the ALDO, that is the ALDO program that was undertaken here in the U.K. was submitted to NICE. Now this is in 2016. It's just -- it's more recently. And just so whoever you asked the question on that, the reason why we as a Board liked it was for the very reason that we had a continuity of evidence base reaching back to 2012 onwards, including perhaps the early evidence that maybe wasn't strong enough in the U.S., but was now much stronger. So when we acquired the company, it was for the very reason that I, for one, felt that their combination of improving evidence base, together with a very attractive health care economics attached to it. So this is for PARP inhibitors and the avoidance of -- or the early indication that we need to onboard or get the woman into the right place for treatment, that the evidence was particularly strong. And that's why, so I don't need -- this is not a company answer. This is a NICE answer, why NICE gave it a recommendation and why it's been taken up now by the NHS. So hopefully, that answers that question.

Next question, your final results say that given the challenging markets, we will grow revenues whilst maintaining a tight control over operational cost target, break even, break profit position over the medium term. We expect to do a scale business model whilst delivering strong growth in our core markets. Are you saying that you do not anticipate asking shareholders for additional funds?

Well, I mean I can say those things out. We jump to the conclusion of there are no funds is one thing, but let's just tackle it in terms of where we are. I am always, and I think that would surprise me if further put things being different, but we're reluctant to take any capital unless we can see significantly adding value. So as you can see from the way we're moving, we're going to continue to generate improving revenues, margins, keep the cost base tight and look for less and less reliance certainly on the capital markets. That's not something we want to do. At the same time, when we set out to build the company, we always said that we need sensible amounts of investment to make sure we can deliver on what we're building. So that's, if you like, leaves the door ajar but it isn't a black and white answer. So we're also considering and I can tell you this, that there are also collaborative potential opportunities that we're thinking about, perhaps nondilutive capital as well as something that's on my mind. So there's a number of other avenues. It's not all on another raise or something along those lines. And to be perfectly honest, in any event, when it does come to, if it does come to that, based on what we're doing and what we're pursuing, it won't be a large figure because as you can see from the numbers, we're improving and strengthening as we go. And if we do find another channel, it will be what I would say in the current market or certainly for the technology we have and where we are, a very light touch in terms of a capital raise. So it's not only the only game in town, and there are other things going on. And perhaps as we move forward over the next few months, we'll give a bit more color over that. But for now, yes, there's no intent to look to raise. We're doing pretty well. I'm very pleased about the growth we've seen so far year-to-date. That's not top of the priorities for our focus at the moment.

Next question. Have you considered making an offer for Oxford BioDynamics? They appear to have a terrific product that are struggling to make headway?

I haven't looked at -- I know them a little bit, but I don't know them. I've looked in any -- we haven't looked at any detail or anything like that. So I can't -- I wouldn't be right. I don't think it's appropriate to comment on that. But what I would say is, yes, I mean, if any in the future, if as we grow as a company, if things that are naturally complementary and add value to what we're doing and sensibly positioned, then we'll look at them. But I don't know any detail behind that. So maybe it's just a pun from someone out there, who knows?

Next question is, what has been the response from the NHS and the University Clinic President regarding the implementation of Lipid inCode? And can you please comment on your expansion plans here?

Yes. So both of them have grown since we introduced them and they've only been really growing for the best part of 6 to 8 months now in the U.K. and also roughly speaking, in Germany. I can tell you that, as I said in the presentation, and I don't know when that question came in, we're already expanded somewhat in the north of England through Newcastle, Leeds and Sheffield. The other thing that we've done, just to give further color to that is, we now have the system set up whereby we collect the samples for testing from the NHS, and we get the reporting directly back into the physician who raised that, so it goes directly through our systems back to them, providing the reporting. So it's a significantly advanced process that we've now adopted with them. And the feedback has been excellent. They've got a number of papers they're going to be presenting at HAR U.K. in the next month, I think it is. So I mean from the point of view of delivery, turnaround time, and like I said, cost-effectiveness of the NHS, it's a big win, win, win, 3 wins, I think.

Next question from David is, what specific measures are being implemented to maintain tight control over operational costs while scaling up commercial programs. So maybe I'll start that one, and Matthew, if you could enter? I mean, firstly, I expect overheads in 2024 to be around 10% lower, at least compared to 2023. 2023 was always going to be a little higher. We've got some relatively high one-off costs. An example would be trial -- study trial costs with Indiana University with Kaiser, with MedStar. Those were to contribute towards the high-quality de novo submission we made to the FDA. They are non-repeatable. We haven't spent a penny on study trials this year. So they are nonrecoverable. Secondly, EVERSANA costs, we've mentioned before, EVERSANA, our U.S. commercialization partner. We've always mentioned that the contract with them is flexible. They've done a great deal of work with us and have been a huge help. But at the moment, we have paused that work while we work on other aspects ourselves in-house. So we can scale up and scale down the amount of work with EVERSANA to our own pace as such. So this year's our 2023 costs were about GBP 900,000 lower than they were in 2022. And so far this year, they are 0. I think thirdly, probably things like the lab capacities, we could -- we did anticipate scaling up the labs this year to scale up according to demand for the tests in the future, but we know that we have at least 12 months capacity. So we're going to pause scaling up our lab capacity until our test demand increases, which is absolutely the right thing to do. Head count increases. We are not going to increase headcount until we are a little bit nearer to an accelerated U.S. commercialization launch. So we're just keeping an eye on costs overall and only gearing them up as and when the revenue pace it takes that to us. Anything I've missed there, Matthew?

No, I think that's it. I mean we -- on that cost side, we're doing it in a very -- it doesn't mean that we are very busy, and I'm spending a vast majority of my time focused on making sure we engage and grow the U.S. And we're obviously keeping headcount and resource recruitment to a level which is commensurate with our growth. We've got to make sure, though, that we're growing the right way, but it isn't in any way an accelerated process whereby we are leading with resource investment. Now it's the other way around. We're leading with revenue delivery and lagging with that investment to some extent. So no, I think it's coming us as a pretty good summary, Paul, I think it's about right.

Another question from David. Can you explain the strategic significance of launching Cardio inCode pilot in Spain and share any results so far.

I can tell you it's gone well. The Extremadura piece of it is pretty advanced. There are 8 main regions within Spain and Extremadura is perhaps leading them. Andalusia and Catalonia are also following quickly and there's a couple of other regions coming. Typically, what happens or what we expect to see happening is as it engages more so in Spain, they're a little bit like a domino effect. The other regions follow. They tend to be joined in that way in the way that they operate. So no, it's going well. It's engaging. It's taking time. The budgets are obviously still for them as a nation and for health care is still obviously challenging. But we're pleased with progress because it's becoming now a little bit like the U.S., recognize that polygenic risk assessment is key not only in the U.S. but also in Spain.

Unless there's any other final questions. That's about it. So maybe we can hand over to Alessandro.

Perfect. Matthew, Paul, thank you very much for answering these questions from investors. And of course, company can review the questions submitted today, and we'll publish a response on the Investor Meet Company platform. But just before redirect the investors, providing with their feedback, which is particularly important to you both, Matthew, could I just ask you for a few closing comments?

Thanks, Alessandro, and thanks, everyone, for attending. We are -- if there are any other questions, if anyone has any further thoughts, don't hesitate to reach out. We're conscious that we don't always see everybody face-to-face. And this is quite a good opportunity for people to see at least and get some insight in more detail than perhaps normally. So -- but no, if you've got any further comments or questions, please reach out to us. But in the meantime, thank you for your attendance at today's call.

Perfect Matthew, Paul. Thank you once again for updating investors today. Could I please ask investors not to close the session as you all will be automatically redirected to provide your feedback so that management team can better understand your views and expectations. This won't take few hours to complete, but something that shall be greatly valued by the company. On behalf of the management team of GENinCode, plc, we'd like to thank you for attending today's presentation, and good afternoon to you all.