GENinCode Plc (GENI) Earnings Call Transcript & Summary

Good morning, and welcome to the GENinCode Plc Investor Presentation. [Operator Instructions] Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Matthew Walls, CEO. Good morning, sir.

Good morning, Lilip, and good morning all. So I'm in the Cavendish offices in the City. Normally, I would be here alongside Paul Foulger. But unfortunately, Paul, this morning has had an issue getting into London. There's been a problem on the line coming to Waterloo. He hasn't arrived into Waterloo yet. So he may or may not join us, but -- so in the meantime, it's just myself. So I'll move through things as we typically do, probably at some pace. There's quite a number of slides to get through, and there's quite a lot of updating for the market. So let's move on. I'll pick up on the main headlines on the financial and final results from 2025. So that's year ending December 2025. We'll take a look at the business in terms of what's happening in prevention, some of the changes more recently that have been announced, U.S. strategy, EU and U.K., and then we'll finish on the financials and outlook. I won't go through the summary of the company. I'll assume that most investors are familiar with that. I will start here now. So this is the progress update for the year ending December '25. Good growth, albeit I would have liked it to be significantly higher than that. But what it does hide that 14% growth is the fact that we've seen a reduction in the NHS, which is disappointing, having made a really good and successful program of work for prevention of heart disease here in England and Wales. The NHS has reduced funding and cut back significantly on external procurement. That said, I'm pleased to say that in the last week or so and only recently, I've had further discussions with the NHS. So we're expecting to see that come back, but disappointing because we would have seen much higher and more significant growth in '25 had that been in place. The second big point is in the FDA. And again, I'll come back to these in a bit more detail as we run through the slide deck. The group, and you'll be aware that we filed our de novo submission, the initial submission back end of '24 into '25. We received an update from FDA in April '25 that they would not go ahead with approval and cited a number of deficiencies. We've worked really closely and I've worked very closely with the FDA over the last 12 months and notably in the last 3 to 4 months to make sure that everything we're doing delivering resolutions to those deficiencies is firmly in place and agreed with them because we're now preparing to submit further submission. It takes time working with them. There's a lot of mechanics around submitting, waiting for a period of time and then getting feedback. But I'm pleased to say that process has gone well. When I have all those discussions, it's also surrounded by the key opinion leaders in the U.S. who are with me with the FDA. We've made good progress with them, and we expect to make the filing in quarter 3 of this year. And that should then complete all of the -- we will have resolved all of the deficiencies. It's a significant program of work. And again, I'll touch on that in the next few slides. Thermo Fisher, really pleased with the program of work we've done with them. We've now completed the first manufacturing of CARDIO inCode. And I say in one sentence, completed the manufacturing of CARDIO inCode. That program of work involves 3 different manufacturing plants around the world, pulling it together as a final finished product medical device and then positioning that for then not only regulatory validation and processing alongside what we're doing in GENinCode, but then positioning through the Thermo distribution channel so we can send the product into market. It's a significant process. We worked really closely with them toe to toe over the last 6 months. It's worked really well. So I'm really pleased about the way that's gone. Over the next 6 months, we'll be taking the product into the U.S. and European market. I'll come back to that in terms of the phase introduction and what's happening on that side. U.S. sales, again, they've grown in the year. We'd have liked to see higher as well, grappling with insurance payments and things like that. We hold a high provision on the sales that we're making in the U.S., mainly because we've got to be confident that we receive the insurance payments from the big payers. It's around about 75% provision. So we're not declaring anything like the gross level of sales we're making, mainly to ensure that we're doing things in a very cautious and a careful manner. But nevertheless, sales grew. At the end of last year, we had 40 client accounts. And bear in mind, that's mainly driven by myself and another individual in the U.S. So we don't have a big sales team. But again, we've seen significant pickup in the last few months in the U.S. So I'll talk about that again in a few slides' time. We got New York State Department of Health approval for CARDIO inCode at the end of last year. Similarly, we got reimbursement from Medicare, Medicaid CMS last year, again, positioning CARDIO inCode well for growth over the coming years. The main growth within the company in revenue terms to date is around LIPID inCode. It's still our core lead product. And as I said to start, NHS was good growth through 2025, although started to come off as they cut back on procurement externally. Good growth across Spain and Europe, really pleased with the positioning across Europe. Spain has done particularly well in the last 12 months. And notably, Italy and Germany still growing, albeit a little bit slower. But again, we expect to see further growth and strengthening of that this year. Notably, in Spain, we took the first region, the Catalonia region, this Catalonia and Extremadura that are currently piloting. We haven't announced and published the results from the Catalonia study, but I can tell you, we're very excited, very pleased and they've been very successful. We'll be presenting those results at the forthcoming annual conference at the ESC in August this year. In the meantime, we're positioning ourselves for further rollout across the Spanish regions with CARDIO inCode. And to finish on ROCA operationally from last year, again, good progress, albeit slow partly because of the financial restrictions in the NHS, but good growth in terms of the UCL Group, UCL here in London. We also expect to be announcing very shortly the further London partner trust coming in and other trust up and down the U.K. are also expressing interest, again, largely held up by the fact that they're under financial restrictions in the NHS. So good, strong growth. And bear in mind, with ROCA, it's 100% margin. It's an algorithm that we're talking about in the way in which it stages onset of ovarian cancer. So that's a quick operational summary. I'm now going to walk through and give you some of the headlines in a bit more detail in each of those areas and what we can expect not only this year but into the future. So this is the portfolio. So gradually going green in terms of -- all of that is regulatory approved in line with those areas at the top there. You can see the FDA is amber as we prepare to put the final submission in. The other areas in green are all regulatory approved. So that's clinically approved regulated products for polygenic risk assessment, mainly in cardiovascular disease and then the ROCA test at the bottom. Important to note, you don't see this, but it's the backbone infrastructure by which we deliver our tests into the European, U.K. and U.S. market. It's a system called SITAB. When we set the company up in 2018, we acquired the rights to use this system from Ferrer Pharmaceuticals. And over the period of the last 8 years, we've carefully refined, developed it. So it now houses and holds all our data repositories, all our algorithms, our risk scoring, and it's set up to operate and deliver scale growth in Europe, U.K. and the U.S. This is becoming a really important piece of the way in which we scale what we do as a company, and it's wound into everything we're doing with the Thermo Fisher collaboration. So very valuable, but it's behind the scenes, not often seen in terms of what we're doing, but a really important piece of the way we're growing and scaling what we're doing as a company. This is the U.S. market. Again, I won't spend much time on that, but it's a significant growing and concerning market in terms of heart disease. Again, just to give you the headline focus, mainly in the areas of regulatory reimbursement and commercial scale. We're not developing, technically, or spending on anything on the development side. It's all around scaling and growing what we're doing as a company. And the main focus has been certainly recently in the last couple of years in the U.S., focusing on the key opinion leader in the leading institutions, which has then given us a foothold to be able to start selling products and testing into them. And I'm coming on to in a moment, the recent guideline changes, which are now accelerating that process and program of work. So the guidelines for polygenic risk assessment of heart disease. So this is the first time genetics have been included as part of the risk assessment for heart disease. And when I talk about heart disease, I'm talking about atherosclerosis, angina, heart attack, MI, revascularization and so on. These are the events associated with heart disease. Typically end of life. But in terms of the genetics of individuals in the population, some of us are more predisposed to the onset and acceleration of heart disease than others. And especially on a family-by-family basis, it becomes more evident. So in March of this year, we're really pleased because we've been working closely with the ACC and the AHA over the past 4, 5 years. And in March of this year, they recognized that polygenic risk score should now be part of the risk assessment for heart disease moving forward. It's somewhat overdue, but again, it's not easy to produce polygenic tests. There are very few groups who are currently in our position and even fewer who are publishing what we're doing. In fact, we're an N of 1 when it comes to these publications. And we're really pleased because the guidelines have shifted in the 3 areas of our main publications, which are risk reclassification, younger adults, so we're able to see much earlier in life those individuals who will be affected by heart disease later in life and then the family history. So an ability to be able to see within a family, those individuals most at risk. So that's what we do with CARDIO inCode. It's all about insight, understanding personalization. The guidelines have shifted so that they're now in 3 group areas. So you calculate clinically the risk for the patient, you personalize that risk by running the CARDIO inCode test. And then as a result of that information, you reclassify the patient for treatment. So whether that's in terms of earlier in life, whether they've been advised to be aware that they have a genetic issue for the future or whether it's then onboarding immediately for treatment, statin treatment, lipid lowering, antihypertensives and so on. The good thing about this is, this is a population of patients where when you identify them, we can really effectively treat and prevent heart disease. Somewhat unlike oncology, we showed in one of the publications in the last few years that by identifying those individuals, we're able to reduce by half and prevent by half the likelihood of an event in terms of heart disease. So these are big swings, big impacts. And at a population level, we're delivering health care in a cost-effective way. Bear in mind, this is a test that you take once in a lifetime. And given we've seen -- you can then identify those patients at risk, we can then effectively treat them with low-cost therapies. So this is a big change in medicine. And it's not only in cardiovascular, other disease areas are following a similar polygenic risk approach. So as a result of those -- the guideline changes, we've seen a significant pickup in the past few months. So from the 40 clients at the end of last year, we're now up at 70 at May. And bearing in mind, this is -- we don't have a big sales team. Like I said, it's myself and one other individual selling in the U.S. But now what we have is we've been -- we're supported by our collaboration with Thermo Fisher. So I'm now in discussions commercially with them and several discussions on several different fronts with several different groups and divisions in Thermo as to how we mobilize and move CARDIO inCode into the U.S. and European market. So a lot of discussions going on with Thermo. But you get some feel for the way that we're West Coast dominant and to some extent, East Coast, too, which are the main institutional groups that we focused on and the main key opinion leaders. But we expect to see that continue to grow, continue to expand. It's both insurance sales as well as self-pay. It's weighted more on the insurance side to LIPID inCode and with CARDIO inCode coming into the market, more self-pay at the moment on that side. But over time, both, we'd expect to see CARDIO inCode pick up more on that insurance coverage piece as well. FDA, just to give a quick update there. So I mentioned that a lot of time and effort spent with them getting everything aligned so that when we submit this next de novo submission, premarket approval submission, we've answered all of their points of deficiency. There weren't significant numbers of deficiencies, and they were mainly around what we call the clinical validation piece, population analysis and medical chart review. The population analysis is subgroup analysis of the U.S. population. They wanted to see more African-American population. And that's difficult because the African-American population are not as significant -- it's difficult to get DNA details on a large population number of African-Americans, sadly and partly because the socioeconomic side is they're not present in high numbers in the big data sets that are held in the U.S. So what we did was we've worked closely with Kaiser Permanente to pull together all of their internal cohorts, which has given access to around about 400,000 patients. As we go through then the inclusion criteria, it will drop back to probably half that near 200,000, and that will be sufficient for the FDA to get comfort. It's not 200,000 African Americans, that's 200,000 as a U.S. population. But within that, there will probably be something in the order of 20,000 to 30,000 African-Americans from which we can then establish that subgroup analysis for African-Americans. It also covers European ancestry, Hispanic Latino and Asian being the other major ancestry groups we look at. But as you can see, too, we're looking now at approval and the FDA are particularly keen to ensure that this test will become available to every adult between 30 and 70 years of age. And it will become, as it's now gone into the guidelines, part and parcel of the regular annual and ongoing annual assessment on a lifetime basis as we move forward. So again, once in a lifetime as a test, but every individual over a period of time will be expected to have that test and it will become part of their medical record. So a lot of work with the FDA, but I'm feeling pretty solid about where we are. We -- the other good thing that we did late last year in December, and this was helpful for us in the guidelines was we -- one of the last major publication we put out in December showed the importance of polygenic risk score in modulating cholesterol. So where you have a cholesterol level, which typically may be under normal clinical measures would be regarded as low. If you don't -- if you're not aware of that the individual's polygenic risk assessment, then that's an incomplete risk assessment because the polygenic risk score is modulating up the risk of cholesterol. So individuals even with a lower level of LDL cholesterol. It magnifies or modulates up that where the patient has a high polygenic risk. And so that paper, it was published in JAK in December last year. And as a result of that, that certainly swung a lot of the authorship and reviewers to change the guidelines in March. The guidelines are not updated very often. It's usually every 10 years. So really pleased that they've now moved to include genetics in risk assessment for heart disease. And again, just to remind the market, heart disease is the #1 killer, not only in the U.S. but globally. So we'll be submitting in quarter 3, '26, and we're also supported increasingly in the last few months by the work we're doing with Thermo too. Okay. So just moving over to Thermo. The program is in 2 parts, Phase I and Phase II. Phase I is getting -- and this is partly a contingency play if the FDA took longer to go through approval. But like I just said, we're not anticipating that, but it's important that we have a contingency play just in case. So we're moving forward on 2 phases, one with the in-house assay. So this is an LDT-based approach, a lab developed test approach, and Thermo preparing all the component pieces to go into the market. They'll then be using that as local labs to plug into our systems to give them a cardiovascular risk assessment. So it's not CARDIO inCode. It's effectively a lab-developed test by labs in the U.S. Once we receive approval, and it's not only approval in the U.S., but also here in Europe as well under the heading of IVDR, we'll have medical device positioning and Thermo are also preparing now what we call a kitted solution or a full medical device. So they're the 2 forms. And as a result of that and the work that we've done in the past 6 months, I'm now in quite detailed and long-winded discussions on commercial supply moving forward. So over the coming months, I would expect to update the market on those discussions. They're both in the U.S. and also in Europe, too. And this is then the engagement on a much bigger basis of CARDIO inCode as a test at a, let's say, a more global level. Again, just to quickly give you some -- if you look at the blue box here, we currently offer the full service. We're selling between $300 and $500 a test. Cost of goods is $25 to $35. So it's a really attractive margin at 90%, but we cover all the overheads, which is significant. To the right-hand side of that, you've got an indication of what the model will look like with Thermo. So it will be sold between $125 and $250 to labs by Thermo and ourselves. The cost of goods on that will be $25. So a slightly lower margin, but importantly, much higher scale. We don't pick up the lab cost because we're not service providing ourselves. It will be through other labs in the U.S. We provide our SITAB capability for reporting and the risk interpretation to the physicians. So that's all done online in the cloud. And then there'll be shared selling between what we're doing ourselves and then support from Thermo. But that then gives us significant lab multiplier. At the moment, we're doing all of the work from our single lab in Irvine. So we get the lab multiplier. The test pack size, just to give you an indication of that, we sell a sample test of 1. The minimum test pack size will be a sample test of 40 with the Thermo collaboration. And obviously, we then move through international reach as well. This is the program. Again, I presented this a few months ago when we went through the funding round. You can see that the areas in yellow are where we've progressed to date. Good progress. I'm really pleased with that. We have a really close working relationship day-to-day with the Thermo team, and we're working with them in different areas. So Pleasanton, California is where the plates made. Ravensburg, Germany is where the controls come from. [ Vilnius, Lithuania ] is where the [ kit ] solution, the final components come together. It truly is from their perspective and ours now to becoming more of a global reach piece, but it is significant. Their working input has been great, and we're working really closely with them. So I'm really pleased about the program to date. The next half, you can see that the latter side, the right-hand side of that is all about then taking the product into market as both an LDT and also post FDA and IVDR as a medical device. That's the program we're moving through. This is the way we'll be -- the way I won't spend time on this, but this is the way that the genetics comes alongside the clinical risk assessment. So you're adding in now a genetic feature risk enhancer to existing clinical risk. And remember, clinical risk is at a point in time where the clinical symptom shows. So this is the first time that genetics can -- we can now see in advance of what's going to happen and predict an individual who's going to have future clinical symptoms for heart disease. So this is a really important risk enhancement to assessment of risk for heart disease. This is LIPID inCode. So much a smaller market, but a really important market and a growing market. And in terms of our LIPID inCode test, arguably the strongest test globally in this space. Most of our testing is done here in Europe, but increasingly, that's now starting to grow in the U.S. In the U.S., it's $1,200 for insurance. Out of pocket, it's about $450 to give you an idea of the kind of split between insurance and self-pay. And it's that insurance piece that we have to be careful about what we recognize because trying to get payment from some of the bigger insurance groups is difficult. It takes time. We have to work closely with them to make sure they have everything they need. And that's been quite a learning process. And as a result of that, as I said, we've got a quite high provision in place on the U.S. sales. And so we feel that we're getting more throughput on a regular revenue recognized basis that we're feeling comfortable with. So just so you're clear on that. This was then published by the NHS. So this is moving across into the U.K., really successful program of work to prevent heart disease in the North of England. And sad in some ways that they weren't able to continue. This is -- this will put the U.K. and for that matter, anybody who's working with our program at the forefront of prevention of heart disease. The data we provided to the NHS is not only to identify those who already have an inability to properly metabolize cholesterol, but it gave all of the insight to polygenics for LDL, which is broader cholesterol genes that are affecting metabolism. It gave the CAD risk, the CARDIO inCode piece for prediction of heart disease risk for the future and also what we call Lp(a) predisposition to Lp(a). So a really successful program. I expect it to come back online in the next few months, but disappointing that it's had this interruption because of funding from the NHS. I'm now talking to them at a senior leadership level. I was invited to see them in Westminster last week. We had a successful discussion. So I'm hopeful that things are going to start to change, but disappointing because this would champion us as an NHS and a level of service in the U.K., and I include Scotland for that matter in this. It would champion us leading in this field rather than lagging. The other thing just to note is we provide this test at half the price of what is a smaller level of testing that they do, half the price of the NHS that they currently try and test an area -- in this area. We do it in a turnaround time of 10 days. They currently take in the order of 6 to 8 months to do this process. And as I said, it's a much more comprehensive test. It's a no-brainer. We should be running this in the U.K., and we should be championing it as a nation. This is the process of rollout as and when it starts to come back into play. So back up and running more so in the Northeast. So that's Newcastle, Leeds and Sheffield, where we did most of the work. Northwest, we should be up and running in Northwest is equally strong to support moving forward with what we're doing and also down in London. There are now 7 regions that have been set up on the genetic lab hubs in the U.K., and we'll be working with them. Europe, as I said, really good growth, really pleased with the last 12 months. It's continued to be solid, steady growth. Spain had a good year, mainly around the rollout in the Catalonia region that helped support things, good work through our collaborations, increasing support for what we're doing in Italy and Germany. And importantly, we expect to see this expand further through the collaboration with Thermo. So we expect Europe to continue strong and to maintain the position that we've started to grow. So that's Europe. I'll give a quick summary. So this would normally be Paul, who would give this, but just to kind of give you a heads-up. We talked through revenue. Margins, I'm pleased to say that we took a strategic decision to cut the cost base back in the Spanish lab, partly because the Spanish lab, we worked out of the Girona lab in Northern Spain. It was getting increasingly more and more expensive to work in that lab in the initial days when we set the company, it was a smart move to work through what was a low-cost lab provision of testing, but it's become more and more cost intensive for us. So we've cut back that cost. And as a result of that, coupled with the ability to take up the support for Spain and the rest of Europe from Hammersmith, our lab here in London, we've been able to see significant shift up in margins. So that's why we've seen that 53% to 59%. It will continue because -- to grow, partly because of the mix of margins in the U.K. and the U.S. is higher than what we see in Europe. So we'll continue to see that as we grow. We saw a marginal increase on overheads, mainly off the back of inflation, but also we saw reduced R&D tax credits. So that had an impact on the overheads. Overall, losses were up, but not significantly. We expect them to see reasonably flat through this year. We ended the year at cash of about $0.8 million. And as I mentioned to start, we've just finished in March of this year, the fundraise. We raised $4.7 million, net $4.3 million, and that takes us through to quarter 1 of 2027. The other piece that we anticipate seeing at that point is I've mentioned about nondilutive funding, and that's still where I am in terms of thought process. Discussions ongoing with our friends at Thermo and other areas, maybe not only Thermo, there are other lab discussions going that I would like to see. I quite like the -- in exchange for technology commercialization position that there is an upfront payment, which recompenses us for the significant investments we've made over the past 15, 20 years as we've grown out the company from the early days when it was a part of Ferrer Pharmaceuticals to where we are now. That's still a logical step for us to take. So nondilutive is what we're thinking in the early part of next year, and that's still the runway. But over the coming months, I expect to give an update to the market about where we are commercially with the discussions with Thermo and our other lab partners. Okay. So starting to round up, and I'll give us some time for some questions at the end. These are the key events and announcements over the coming months. So I finished the discussions with FDA, they're now waiting our resubmission, de novo. Thermo, there will be updates as to where we are with what we're doing with Thermo over the coming months. Kaiser, we've got more publications coming, notably with the new guideline changes. We've got a good publication coming showing the -- how much better the new guidelines are with the inclusion of polygenic risk using CARDIO inCode. So that's a good publication. We will be presenting at the ESC Annual Conference, and we're upfront. We've got a nice early presentation. So we're really pleased with the ESC is finding that for us. The ESC is equally expected in the coming months short term to shift its guidelines to include polygenic risk assessment too. And we share all our publications with the guideline setting bodies. The FDA submission will go in at the end of quarter 3, and I expect to give further updates on the NHS, as I mentioned, too, as we get towards probably into quarter 4. We've accelerated the MolDX submission. So in the next few weeks, I'm probably going to submit that partly because the guidelines have shifted so quickly. We were going to do it after the FDA submission, but we're going to try and get it in quicker. And the MolDX submission is, in effect, at the moment, whilst we've got pricing for CARDIO inCode for each state in the U.S. If we go to each state as we sell them and we're rolling out, it's becoming more and more cumbersome to set up each state to not only sell through the physicians there and use the pricing we've got from the CMS, but you have to go state by state. The MolDX program allows us a blanket coverage of 30-plus states in the U.S. So for us to submit that, it will take about -- we expect 3 months, 90 days, something of that order to get that through. It's a much easier bandwidth position for us to work on a blanket coverage than it is to try and do it state by state. Even though we've got the pricing, but we still need to show the clinical utility of what we're doing state by state. It's better to do it through MolDX. Okay. So that's pretty much it. Revenue is up. Like I said, we will be submitting the PMA in the coming months. Growth in LIPID inCode and CARDIO inCode, the 2 lead products. Thermo Fisher will be a key part of that growth position and picture over the coming months and years. We expect to see pickup on the NHS over the coming months with the prevention strategies for heart disease getting clearer. We will be expanding Europe, especially around what we're doing in Catalonia, Extremadura and the other regions. Germany, we expect to see further pickup there. Again, there's more to do, and it's a case of bandwidth. We have to keep the cost base tight, but at the same time, commercially grow what we're doing and similarly on ROCA, everything focused on breakeven over the medium term. Okay. And that's it for the presentation. I'll just pause there a moment, and I'll move across to -- I've got some questions here.

And just to remind the audience just so, Paul would normally be with me, Paul Foulger, our CFO, but he's been held up on a -- there's been an accident on a train coming into Waterloo. I understand it was -- I think there was an animal on the line and the train hit the animal. So the whole train has been held up when he was stuck on the train. So he's on his way here. But if I take a few of the questions, there's -- I can see that there's a long question here on options from -- so I'm just going to mention that. Over the years, when we started the company, we started off with options for the management. There's been a combination of a number of things. We've had a lot of -- we've had a number of funding rounds. And at the same time, we've also had a market that's become less and less palatable around technology investment in health care and a longer term, let's say, patient weight from that investment to see a return. And therefore, we become slightly less attractive. And certainly, post-COVID when we did the IPO, the market as a whole in our sector has not enjoyed great upside. As a result of that, we have reissued options, and we have tried to do it in a way that is fair and incentivize management. Like the rest of the investors, I and the rest of the management team, we invest behind each round. We try and put in what certainly for the Board and each Board member is independent, what they can afford. But we don't -- we hear you. We try and do these things in a reasonable and realistic way. But at the same time, we do have to try and incentivize management. So hence, the options were issued a couple of months ago or a month or so back. Then there's another question. When should shareholders expect the next fundraise? Well, as I've just said, I'm -- at this point, and based on the discussions we're having, we're not anticipating and we're not looking at coming back to the market. I'm resistant to doing that, provided we can find other sources of nondilutive capital, which in itself is difficult to do. But given the discussions I'm having and where we are, I want to exhaust those before we think about anything we're doing possibly opposite the market. And the other important thing is the announcements of what we're doing, I expect them to have an upward increase in the share price rather than anything that would be flat or anything along those lines. So just so we're clear on that, albeit even when we put out that news in the past, it hasn't necessarily been met with an uptick on the share price. It tended to be relatively flat. When can I expect my EIS certificate? Well, I'll talk to Paul about that. Please contact me by e-mail if there's something that hasn't moved through quickly. I know he's been on with it, and that's been moving through. Then let's read, this one is a bit longer, in terms of breakeven. I mean this point about taking longer, I mean, unfortunately, we -- the model for growth, significant growth, growth by which we move into tens of millions of dollars growth, let's say that, is based on us getting CARDIO inCode approval with the FDA and also running the program as quickly as we can through medical device approval in Europe in its form. But remember, we have to do that with a commercial partner that has the bandwidth to do that, and Thermo have all of that. So it's a combination of 2 things. It's one, getting approval; and two, having the scale and capability commercially to take advantage of that. We have that. But unfortunately, we haven't got the approval just yet. So the program with Thermo is both taking it on an LDT to try and get that growth piece going quickly, but the medical device FDA approval is the big one. That will take the revenues up significantly. So it's partly that delay that's driving. So we talk about moving to breakeven. That's what we're aiming for, and we're growing year-on-year. We want to grow faster, but also the fastest of all is obviously on the FDA approval. That's the one that accelerates us rapidly, not only because we're first-in-class, but also the evidence base that we have. What time frame for medium term regarding breakeven? Well, again, if we get through the approval as we expect at the end of the year together with Thermo, we're looking at towards the mid- to late next year on the back of that by the time we start to move to breakeven. The range of forecast that we have is significant, but we still have to have FDA approval, and we also have to have a pickup in the market in the U.S. and Europe. But the first step will be the LDT. The next is the FDA position, and they will be the main accelerators of growth for the company. Okay. I haven't got anything else that's come in, any other questions. [indiscernible] one to ask.

Thank you for answering all those questions you have from investors. And of course, the company can review all questions submitted today, and we'll publish those responses on the Investor Meet Company platform. Just before redirecting investors to provide you with their feedback, which is particularly important to the company. Matthew, can I please just ask you for a few closing comments?

We've -- I think we've touched on most of them in the presentation. We are scaling everything we set out to do. And at the moment, the biggest piece that we need to scale and get over is the FDA approval. It will, though, bring with it significant growth for us as a company, not only in U.S. and Europe, but globally. So yes, I think I'm conscious of where we are. I'm not happy about where the share price is. I can give the investor groups and community the confidence or the comfort that everybody is working incredibly hard on their behalf with the funding that we've received to do what we can to get over the line, to get these things done in a market that's pretty tough, but we're doing everything, I think, that we can. But I'm grateful for their support. And in the meantime, if anyone has any further questions or they want to follow up on anything that I've said, please don't hesitate to reach out. I'm here. I may not be able to get back to you immediately, but I'll get back to you shortly over the coming days, if necessary. So please reach out if you need to pick up with me or discuss anything in further detail.

That's great. Thank you for updating investors today. Could I please ask investors not to close this session as you'll now be automatically redirected to provide your feedback in order that the management team can better understand your views and expectations. This may take a few moments to complete, and I'm sure will be greatly valued by the company. On behalf of the management team, we'd like to thank you for attending today's presentation, and good morning to you all.