Genincode (LSE:GENI) — Interim results - Investor presentation

0:00 Good afternoon, and welcome to the GENINCO PLC Interim Results Investor Presentation. Throughout this recorded presentation, investors will be in listen only mode. Questions are encouraged and can be submitted at any time via the Q and A tab situated in the right hand corner of your screen. Just simply click Q and A, type in your question, press send. The company may not be in a position to answer every question received during the meeting itself. Have the company review all questions submitted today and we'll publish responses where appropriate to do so. Before we begin, I'd like to submit the following poll. I'd now like to hand you over to Paul Folgers, CFO and Matthew Wallace, CEO. Good afternoon. Thank you, Paul. Good afternoon, everyone. Just to to kind of follow on to to what Paul has just said, who hosts the platform, this is the interim results for the first half of twenty twenty two for GENINCODE. I'm Matthew Wall, CEO and Paul Fulgier, CFO, both on the call. So we're gonna move through at a fair amount of pace and hopefully that'll allow us a little bit more time to take questions at the end. And also the first part of the presentation, those who are familiar with it, there may

1:00 be a little bit of repetition. So we'll move with a little speed. Okay. Overall, board brief introduction to the company. Results. Think on the product portfolio, what we're doing in terms of cardiovascular disease prevention, diagnosis. We'll then spend some time around US strategy, UK and EU strategy. And then we'll finish up on some of the announcements today, the ROKA acquisition of AVCODE PLC we'll take a look at the financial summary and outlook. Board. No real major changes on the board side. We brought Felix through on earlier this year. Felix is based on the West Coast. He brings a lot of entrepreneurial background, so it's been a a good addition to the board.

1:49 If anything, the board is beginning to strengthen. We've got Huean Gray who's now been with the with the group for the last six, twelve months. It's good to have Huehn on board with his background in the NHS cardiovascular care. The rest of the board are unchanged from the IPO which is just some twelve months just over twelve months ago. And it's also fair to say that we gave the last update the prelims in March in May rather of this year so it's really only four months since we had the last update It's just the way that things fall out but it does mean that in the last four months and especially with summer in the middle it's quite a period from which to then update the markets again on what's been happening but I'm pleased to say there's quite a bit to pack in so we're going to quickly move through that now okay so just to refresh people who are not familiar with the group we're a clinical genetic diagnostic company mainly focused around polygenics that's multiple genes risk assessment and we use algorithms and bioinformatics to report those risk assessed genes to physicians in the form of online reports. We have our own infrastructure for doing that. It's a cloud based system called SETAP. We're revenue generating primarily in Europe, mainly out of Spain and Italy.

3:11 CE marked here in Europe and we filed our US pre submission late last year and I'll talk about that in more depth as we move forward. We've invested significantly over the period of which GENINCODE originally set up as FerroEncode and GENDIAG back in 2007 and more recently as GENINCODE when we acquired the companies from FerroEncode in 2018. We've got significant evidence base mainly around the publications and work we've done with Kaiser Permanente on the West Coast. And importantly, that gives us access to population based data and increasing those populations that we use for the evidence base for our products moving forward. We have IP protection on the core products. Some are now granted, especially in The US and Europe.

4:00 And we're not a single product company. We've got four products all of which are driving forward and growing in relative terms. And we're focused in the area of cardiovascular disease mainly because it's the biggest area of mortality globally. A significant amount of issues in terms of growth in this area and recognition that the current clinical risk assessment is not something that is working adequately. Over the last fifteen-twenty years there's been growing evidence now that genetics plays a vitally important part to improving risk assessment and diagnosis of cardiovascular disease and that's what we do we bring that missing piece the genetics to provide better risk assessment for physicians moving forward. So here's the interim report. This is a summary of what was presented this morning. I'll carefully walk through it and come back maybe if one has questions later in presentation.

4:56 So we filed our pre session with the FDA at the back end of last year, really late in December. First part of this year was taken up with discussions with the FDA constructive, strong and very structured around what their expectations are for our product cardio encode going forward I'm pleased to say we've moved swiftly now towards preparing the final five ten submission it's not only a submission that is supported by the work and evidence on the clinical validation we've done with Kaiser but it also pleasingly from the beginning of this year when we were considering whether it was a de novo or a five ten ks submission five ten ks has become a key part of the guide rail for taking this product forward the FDA advises that they would be prepared to take a predicate substantial equivalent device mainly around the safety and efficacy of that product and that's what we're using as our predicate it's an interesting predicate not because it's directly related to genetics far from it it's related to an enzyme analysis put in the area of cardiovascular disease so it's been helpful for us to have that as a predicate as we've built the five ten process.

6:13 We've now set up our US clear lab that's been a lot of work and effort over the past few months certainly over the best part of summer to build that out the clinical lab is set up for production of and testing in support of cardio encode and lipid encode moving forward We're just starting it on the verge of our early access program. So this is taking our first products into The US market, Lipid Encode and Cardio Encode. And our expectation is that with those products up generating testing from the end of this year in the CLEAR lab, we'll be able to look at our first revenues albeit small market revenues moving into The US market next year. Indiana University is also one of the collaborations we've got on stream at the moment that continues to build and there'll be further reporting on that as we go through that ongoing collaboration.

7:04 It's also one of the core groups alongside NYP, New York Presbyterian, Kaiser and also a new addition MedStar from Georgetown Washington that are also now starting to take our products in The US system. We've expanded the collaboration with Kaiser so that's been an expansion not only in terms of time as we work more closely with them but it's also likely to lead to clinical utility work going forward and also perhaps not only Cardio Encode but Lipid Encode working with the healthcare system there we announced the Bupa Cromwell that's the private work that we've got ongoing at the moment here in London early in the year two that's the first UK revenues and for lipid encode coming on stream and also at the beginning of the year we announced the successful publication with the NHS clinical study we then went on to do some pilot work with the North of England HSN that's North England and Cumbria and I'm pleased to say that was successful and we're now starting to implement lipid encode with the NHS so that's the first commercial polygenic test with the NHS In addition in the background and I think as perhaps most people are aware we're not focused directly on COVID but our ongoing product for affiliate and brood clotting seem to have a significant alignment with patients who are suffering with severe onset of COVID. We announced the first study to support that early in the year.

8:33 We expect to have another study come later this year which could support that same process too. On the basis of that second publication, we'll also look at an emergency use application so that will accelerate that product into The US market. First half revenue is marginally up, not significantly but showing that European market is coming back, especially in Spain and Italy. EBITDA loss tight whilst it's grown since last year from 1,000,000 loss. It's still much lower than was expected at this point. And as I think most people are aware, as we saw the market changing from just after the IPO last year, we took a strategy to keep costs tightly under control and firmly move towards delivering whilst keeping that cash burn really tight. And that's reflected in the cash reserves at 12,400,000.

9:25 We raised GBP 15,300,000 net of expenses at the IPO and we're in a strong cash position as we move forward. So at the end of the full year in June roughly cash position is pretty solid and we anticipate that that should remain like that certainly over the next twelve perhaps eighteen months looking out there is no intention to do anything on fundraising basis at this stage we're also announcing today the first pilot implementation of cardio encode in Extremadura in Spain which is the first engagement of cardio encode in the Spanish market and that's the public markets in Spain Extremadura is one of eight regions so that's a good step for us in the Spanish market and also today the announcement of the Abcodia acquisition of the Roka test for ovarian cancer it's an algorithm that aligns really well in oncology around what we do in cardiovascular in terms of risk prediction and the onset of staging of ovarian cancer we expect to update the markets in the coming weeks on this test.

10:31 There's been some interesting developments. It's a pretty interesting deal for us. So we'll come back in the coming weeks to advise the market further once that information becomes more available. And also we've commissioned our UK lab just down the road from the Royal Brompton which is where we set up. We've pretty much outgrown the lab now and in support of the NHS we have our own lab coming online just down the road in Hammersmith, London. So that's a quick race through the summary headlines again just to reflect on this is where we are items in green tick there are the areas that we're currently generating revenue those in amber coming online with early access programs you can see at a glance where we are in terms of the products moving forward but certainly as we look now towards the end of this year and into 2023 the main focus is moving our product into The US market and starting to generate our first revenues mainly around lipid encode and cardio encode later in the year next year on the assumption that we start to see regulatory approval coming through again for those who are not familiar the process by which we develop and take our tests forward we collect samples it's a fairly simple process at the high level we collect samples they go off to the lab we process those samples extract DNA run them through our risk assessment processes and then deliver the reports back online to the physician we do that through our state of the art system sitab and it's proving to be a good system

12:01 to roll out not only here in Europe but we're doing exactly the same with the system in The US too and here is The US market it's a significant market in cardiovascular disease over eighty five million Americans at various stages of cardiovascular risk and disease. It accounts for nearly a third of all deaths in The US, significant in terms of mortality, so twice that of cancer and significantly above anything on COVID basis. And as you can see the cost to both healthcare and the economy in The US is staggering and also is set to grow somewhat significantly and out of control over the next ten years. So diving in a little bit more detail now to to where we are in The US.

12:48 We appointed Evasana just over a year ago as our commercial partner. Not only have we grown with Evasana with with the the deal terms, for those of you who remember, are quite attractive. It's a three phase process. The first phase is a cost share, risk share, where for every 50¢ we spend in The US, they hold 50¢ and charge 50¢. So we pick up half the cost in phase one phase two as we move into revenue we pay back the 50¢ that we owe them and in phase three we move to a commission based model it's a tidy model commercially because what it allows us to do is keep spending tight and cash flow extends that cash runway as we move forward. And importantly, since we moved in certainly in the last six to twelve months as the markets have tightened, it's allowed us to tighten up on the cost funding.

13:39 So we're spending a much, much lower rate than we expect to originals at the same time, pushing on and delivering on regulatory pathways. For those of you familiar with the regulatory side, we had the MSIP process repealed was in line with reimbursement and the breakthrough this was September, October of last year and we went back to more traditional process for regulatory filing. So we do a five ten submission process. And as a result of those productive discussions we now have we're now nearing the completion of that five ten and it's filed at this time so we feel in a strong position on the regulatory reimbursement the clinical utility work we're doing with Kaiser MedStar NYP and Indiana should give us a strong hand for moving forward with the MALDIX submission but that's not anticipated until around about quarter three of next year after we get through what we hope is the regulatory approval from the FDA midway through next year.

14:40 Commercial operations as I mentioned we've got the CLEAR lab now set up in Irvine just South of LA both lipid encoding, cardio encoder coming up in the laboratory there. So we expect to be able to service the market on an IRB basis, research use only over the coming months from the Irvine Lab. And I can also confirm that we're having ongoing discussions with pharma and over the next few months we'll probably give a further update on how those pharma discussions are going primarily around identifying patients at higher risk and therefore aligning with the right therapies from those pharma groups. So it's very much a precision personalised medicine approach.

15:23 These are the core institutional groups we're working with so East Coast NYP at the bottom, Midwest Indiana, West Coast Kaiser and MedStar coming on in Georgetown Washington. And each one of them gearing up to not only move through clinical validation then through clinical utility. So that's utilising the products in these institutions, but then going on to obviously adopting the products moving forward. So we feel that the strength behind the key opinion leader groups that we have there coupled with them now starting to take product on a free of charge basis so IRB so research use only is a good strong position from which we can then start to move the products into The US market. This is a summary partly in line with what I've said here at the top half of this slide, you've got the regulatory timeline for cardio encode and as I said, we expect to file our call submission in the next few weeks And then below that, The US reimbursement pathway as well. So you can see CPA PLA coding coming online towards the end of the first half of next year. And that's consistent with when we'd expect to broadly and hopefully get regulatory approval. And then moving through the MolDX submission, that's the clinical utility work finished by those big institutions.

16:43 So it probably won't be till the end of next year at the earliest that we start to see CMS pricing specifically for cardio encode. So just to note, this has not got a CPT PLA code, and it will be a first in class code for this product.

17:03 Again, just to reflect on the market size of the eighty five million patients who are suffering with various stages of cardiovascular disease, roughly twenty one million of that group are identified as intermediate or low risk patients. And it's this group that we'll go to in the first instance to target with cardio ENCODE, with the intention of moving them from either a low or intermediate risk with knowledge of what their genetic risk is into a higher risk category and therefore changing the treatment pathway for those individuals. In parallel with that, we continue to build out the work with the ACC and the guideline changes. Now, the guideline changes won't change until a product is in market and again we're in a strong position to be the first mover into The US market in this area. So we're quite close to the American College and also the American Heart Association who recently have put out a really strong testimony to apologetics in this area, advocating that really the next stages of improvement they see to risk assessing and diagnosing cardiovascular disease will be through the use of polygenics moving forward. So it's a helpful support for where we are at the moment as we move the products forward in The US market.

18:23 Just moving over to lipid encode now. So lipid encode, at the beginning of the year when we started, we'd we'd placed firmly cardio encode in in the kind of fore foreground with a with a view to lipid encode following it. There were some changes by the CDC, US CDC about moving familial hypercholesterolemia, which is what lipid encode diagnosis into a tier one status. And at the same time, local coverage determination from some of the MACs in The US who are now starting to reimburse for familial hypercholesterolemia. It's now also part of the clinical lab fee schedule and we have CPT coding and an ICD-ten codes for the codes we need to test for FH and lipid encode. So as a result of those changes we've accelerated lipid encode now into The US market.

19:14 So it's highly likely at this stage that this will be the first revenue generating product for us mainly because it has reimbursement, CPT coding and it's also being accelerated now as an interesting diagnostic which is being put at the forefront of identifying those patients at high risk of atherosclerosis and familial hypercholesterolemia. So an exciting time for lipid encode and as a result of that what we've done is we've now set up targets on what we term in tier one and tier two targets. The tier one targets, together with our partner, Avasana, will be the main focused approach for where we place our sales resource and endeavor over the next few months. And just to say at the same time over the last six to eight weeks, one of the interesting news points that came out was that Invitae, one of the bigger diagnostic groups in The US had cut out about a thousand people from their commercial part of their company group.

20:16 As a result of that, it overlapped with a number of cardiovascular people in the Invitae group. We've spoken with them and we're now onboarding a small number of executives on the cardiovascular side from the Invitae diagnostic group who are very familiar with selling products including FH into The US target markets we're looking at, especially on that East West North South groups. So the team is being now complemented, the Evasana team, by, some Invitae, hands on individuals who are familiar with selling cardiovascular into these healthcare systems. That'll help us accelerate lipid encode further. So that's a tier one target. Tier two a little bit further out and a little bit more granular so they'll take a little bit longer too. So that's a New York state license here which takes a little longer.

21:04 Around about six months after we've received California clear licenses is where we'll go to next for New York State. So tier one is the main focus around those key institutions, tier two coming at a later point. As you can also see, it's a significant market opportunity. There are around 1,500,000 individuals in The US who suffer with familial hypercholesterolemia. And in terms of the breakdown, I'll show you in a moment, the reimbursement coverage for those is at a significant reimbursement level for us. So in accessing this market, we see there's a great revenue opportunity moving this quickly forwards. So that's the breakout of where we are in terms of population of patients.

21:50 And whilst this is the estimates of how many people are suffering with FH in The US, typically and at the moment, one of the biggest issues is identifying those patients. So even though that 200,000 who have been diagnosed with FH, they're mainly diagnosed around clinical diagnosis rather than genetic, which is the gold standard for diagnosis in this area. A large proportion of that zero point two will also go through further genetic testing to ensure that it is FH monogenic diagnosis which they're suffering with. Moving on, this is the reimbursement for lipid encode as we see it based on the CPT codes we have. So it's part of the clinical laboratory fee schedule. That's the CMS based pricing. And at the moment, it's priced around about $1,400 a test. The LDLR, PTSK nine o, APOPB, LDLRAP1, they're the genes that we focus on in terms of FH.

22:48 But in addition to that, we have we bring a little bit more to it than that. We also have, polygenic risk score, which is complemented with that FH diagnosis and also cardiovascular risk assessment as well. The test that we have is more competitive than current testing in this area. Also at the moment the testing in The US is pretty fragmented it's not joined up in the way that we see this coming forward now into The US market. There's a big opportunity for us to access this reimbursement against that tiered approach that I've just walked through now. And this is the timelines again for regulatory not as much on this side because it's already got approval for us to sell into The US on the basis we're diagnosing FH.

23:34 And this will be part of the setup at the CLEAR lab process in Irvine. So we'll be selling it as a lab diagnostic test, not as an FDA based process. And then a little bit lower below that you can see reimbursement pathway. So with CMS coverage in place, the FH coding now in place and also pricing confirmed, we can start our soft launch process and move to a full launch later next year. Those soft launch are early access programs that we're now starting to build out with those tier one targets.

24:07 Just to go back then to The UK so UK is a smaller market but nevertheless important to us. It's you know, where we're based as a company. We've worked closely with the NHS to set up the original publication at the beginning of this year of the successful NHS study. We then went on to successfully complete a test pilot with the North East HSN. And then more recently, we've announced the implementation in the North Of England now with the HSN there. In addition to that, we're also putting in place a second implementation now down in London. The only problem with this process is that the NHS is still struggling to find budget to pay for this. So we've still got ongoing commercial discussions with them. We expect to see that move, but it isn't easy at the moment trying to find budget to pay for this.

24:58 But the NHS ten year plan calls for a significant and robust approach to this, which needs a sensible and significant budget to go with it. So plenty of discussions going on on that side and we continue to move that in the right direction, but it would be nice to see the NHS ring fencing a budget to properly move this area forward, which is some of the discussions we're having with them at the moment. And this is just a snapshot of what we're doing in the North Of England. It's a 3,100,000 population and within that population we're working with the Darlington Primary Care Network it's 110,000 patients and from that group they are screening individuals with a view to testing for FH and the expectation is it will be around about a thousand tests that we'll do with the group At the moment, we're providing this testing to them on a free of charge basis, but moving forward, we will be looking to get this reimbursed and paid for as part of their budgets and also the NHS budget too.

25:55 But again, at this point, just so that the group are clear, we're working with the NHS to try and identify budget and commercial opportunity to properly engage our products moving forward. We're pleased with progress, but we're disappointed that budgets aren't there at the moment.

26:13 Europe again, we're continuing to expand what we're doing in a Spanish regional level. I mentioned Extra Madura and we're also now putting in place a rollout for cardioencoding, Anviluthia and Catalunya. Still continue to build out our collaboration with Synlab and Longwood and we've expanded a little bit in Italy. We see that coming more online again following the Covid issues of last year. So Europe is strengthening which is good we've also got Germany coming online but that won't be effective until the early part of next year so revenue is growing albeit modest but still positioning and strengthening back to where they were pre COVID. And also then we can see that new products coming on for COVID nineteen potentially first half of next year following the successful publication maybe later this year that we're waiting for. And also from an oncology perspective in thrombo we have a thrombo encode oncology product coming too so strengthening steadily but good results in the first half from Spain and Italy with Germany the prospect looking forward One slide on the Abcodia acquisition so we looked at the company about six or eight months ago and the company has done some particularly strong work around risk of ovarian cancer so these are for women who are diagnosed with BRCA1 or two so they're at risk of breast or ovarian cancer

27:44 and the work that the team have done is to identify those women then post BRCA positive position who are then staging for the onset of ovarian cancer so the ROCA algorithm is what does that it's technology that was licensed from and there's an exclusive agreement with Mass General Hospital out of Boston for the test and the technology. We've worked with the team over the past few months and decided based on the commercial terms that we put in place, this is an attractive product for us to commercialise. It fits well with what we currently do so there's good synergy. It's an ongoing monitoring test, so it's not a one off DNA based test and the development is complete. So it gives us another product in the portfolio that we can start to generate revenue from immediately.

28:31 So we're not looking at developing this as a technology. Coupled with it fits with our HSN rollout here in The UK and also there are steps currently in place to commissioning it with the NHS. There are also some good we anticipate some good results coming in the near future on publication and hence we'll likely update in the coming weeks the next steps in relation to what's happening with Abcodia moving forward. Very favorable commercial terms. No upfront here. Earn out on the basis of delivered EBIT. So on the basis that the company delivers EBIT from this, then we go on to pay EBIT. In two tranches, 350,000. Once that is surpassed, then a payment of 350,000 EBIT is then once the 350,000 EBIT is delivered, then we pay 350,000.

29:19 And similarly, once the next target milestone of 650,000 is delivered, we then make the second instalment. So it's favorable commercial deal arrangements for us and it gives us access to a product that we think we can move quickly on a commercial basis I'll hand over to Paul and he can give you an update on the financials and then we'll return to some q and a as we finish up. Paul? Thanks. Thanks, Matthew. Good afternoon, everyone. So just to recap the company structure, we have GENINCODE PLC, a 100% owns GENINCODE US Inc in The US and a 100% owns GENINCODE SLU in Spain and and now have CODIA limited 100% as well. We listed on Aimia last year, raised 17,000,000 gross 15,300,000 net.

30:09 So revenue is up 10% from 600,000 to 664, so $0.60700000. So, you know, modest revenue growth, modest numbers. But more importantly, as always, it's proof of commercial traction. We have four key products. All have grown in revenue to all our CE marked and all our commercialized. So good solid growth and and hopefully that will continue for the rest of the year. Subsequent to the the half year, we continue that traction, and we're now 13% above last year's figures. So we are continuing to grow. LipidinCODE remains our largest revenue generator, just under half the revenues generated from LipidinCODE, then followed by Thrombo, then then Sudden, and then Cardio ENCODE.

30:57 Gross margins have dipped a little bit on last year.

31:01 That's mainly because we still have some pricing pressure on our main laboratory service provider, which is EDIP GI in in Girona. But we are continuing to look at internalizing some of those services, and hopefully we can get that to improve going forward. As we've said on previous presentations, Europe continues to be the most competitive sales pricing. So there's not huge amounts we can do on raising prices, but once we see revenue growth in The UK, we should see margins in The UK between the 5060% mark. We're seeing 40% to 50% in Spain and once we launch in The US, should be seeing 60% to 70%. So we do see that blend of products and geographic regions improving that gross margin considerably going forward.

31:52 Operating loss increased from 1,000,000 to 2,400,000. Half of that increase is due to Eversana, so about £750,000 of costs over and above this time last year. And the other half is due to salaries and and rent and and equipment that we purchased to gear up our UK and US labs ready for commercialization. So headcount is gone up from 22 to 32. So that's salaries is obviously a key increase there as we gear up the team. Just a quick note on working capital. As we've mentioned in previous presentations, there's two key points here. We hold firstly minimum inventory. So 60% to 70% of our revenues are from service testing. So that's clearly no inventory being held there because services provided directly from supplier to customer.

32:48 So no inventory. And secondly, payables, as Matthew mentioned earlier, the Evarsana working capital deal is very favorable to us from a cash perspective. So for every dollar that goes through the P and L, we pay 50% and defer 50%, which is paid back through revenue generation. So you would have seen an increase in the payables both short term and long term there. And cash, 14,600,000 at end of December. So that's now GBP 12,400,000 at the end of June. And we've had a couple of months of £500,000 cash burn. So we've we're now 11,400,000 at the end of August, but we've seen cash burn of around 400,000 a month for the first six months.

33:36 We anticipate that moving to around 600,000 a month for the next fifteen, sixteen months or so. So we're confident that we have enough cash to get us through to early twenty twenty four, and that's including the small extra costs incurred on the operating costs for our Codia Limited and exchange movements that's recently occurred in the markets. So, yeah, Matthew, back to you. Thanks, Paul. Okay. So, I mean, just to echo that, we we continue to keep costs tight and deliver, you know, firmly, you know, in line with what we what we plan and set out to do. I mean, it it isn't always in line with plan so the M SIT changes that came in September October last year meant that we had to move on to a different regulatory pathway with the FDA but nevertheless what we've done is brought up lipid encode quickly alongside cardio encode and now look as though we're going to generate revenues on that product next year sooner than we will with cardio encode.

34:39 Okay. So this is the news flow over the next six to twelve months. They're the key points. We touched on all of those And then in addition to to to those milestones, there'll also be regular updates in relation to those collaborations moving forward as well. So to wrap up, this is the summary now. We expect to finalize and file our five ten k regulatory submission in the next weeks, month or so. And, again, just on that, it'll be a right first time process. If we need to hold fire a little bit, then we'll get it absolutely in line with where we expect before we file but we anticipate we will be filing imminently. We're advancing in terms of the clinical utility programs with the groups I mentioned and that will support our moldy x reimbursement submission.

35:28 We'll be initiating the first early access programs for lipid encodes. That'll move ahead in terms of cardio for utility at the physician level. We've strengthened the Avasana commercial team with the infusion of Invitae commercial executives. So that's going to be an exciting accelerator into The US market as we move over the coming months.

35:51 ClearLab certification expected in the coming months as well in quarter four. We're commencing the implementation with the NHS for rollout, and we'll continue those commercial discussions. We'll advance what we're doing on thrombo encode and COVID. And we're doing that. We're not a COVID based company, I think, as I as I keep reiterating, but it's an interesting alignment with different approach to identifying individuals at risk of severe COVID infection, which for those of you who follow this space, there's gradually a growing body of evidence now showing clotting is having an impact on on those individuals who are in severe risk, which is consistent with with what we've been saying for for some time now. So that's interesting and exciting. We continue to build out those EU partnerships to strengthen the revenue, and we'll provide a further update on the ROCA test in the coming weeks, months as a next step in the commercial development of the Abcodio acquisition.

36:49 We expect to see increased year on year revenue growth, things recovering more so post COVID, and also the beginning of the revenues coming from The UK and obviously then driving on for delivery of revenues next year in The US. So that's kind of it in summary. I'll hand back to Paul B if maybe you want to move to Q and A. Fantastic. Thank you very much indeed, Matthew. And thank you both for the presentation. And ladies and gentlemen, as Matthew said, if you could continue submitting your questions, just click

37:19 on that Q and A tab, type your question and press in. The company will take a quick few moments to review those. And of course, any questions that we don't get around to answering, we can always pick up post event. Matthew, if I may just ask you just to click on that q and a tab, where appropriate to do so, just read out the question and give you a response. That'd be fantastic. Thank you. I'll let I'll let Paul read them out. Do wanna take them, Paul? And I'll Sure. Kinda So the first question, Matthew, is from Simon. He said with the soft launch in The US, what's the missing pieces for a full rollout? Is it the principle around reimbursement?

37:51 No. It's not. I mean, the soft launch is all about getting the physicians comfortable with the product. I mean, at this point, I'm more interested in making sure the physicians get it, like it, and use it because then with the reimbursement follows, you know, the soft launch is all and obviously, can't sell it directly into the market until people want to to to buy it. But once we've got our product validated in Irvine, we'll be moving on a free of charge use. It's quite difficult selling a product straight into The US market without people getting a feel for it it's a novel product it's not just an FH diagnostic it includes polygenics and also cardiovascular risk so they need to get comfortable with the report understand it it educates them You could almost call it physician experience program as opposed to an early access program because they need to get comfortable with it. But then following that, it then gets it gets interesting because there are two side well, there are several sides, but there's a reimbursement for CMS, which is one of the figures that I showed earlier. And then there is the private payers, so the the Aetna's Blue Cross Kaiser's who currently pay in network or out of network for their physicians to use our testing.

39:01 So that's a whole area that we're stepping into in the coming months that'll be new. It's not reimbursement isn't isn't a an obstacle at this point for lipid and code. It's more another step on the way to us getting commercial value from moving the product through The US market. Okay. Tom has a question. NHS is slow to do anything. How do you navigate this and why do you not focus purely on The US?

39:27 Well, I mean, we could. I mean, and that that's certainly, you know, the the more the the time is takes to get a moving on with the NHS then it becomes a bigger part of our thinking. That said, it's engaging, albeit very slowly, and I think there's a bit here that the NHS is typical in these instances, needs to get comfortable and start to feel comfortable. The key physicians are starting to use it bit by bit. It's being used more privately at the moment than NHS and I expect over the coming months to see more private revenue than we do NHS. So as long as we're generating revenue and making a margin and seeing that there is a value opportunity and an investment return, we'll continue to move it. Just so the group is aware, this is not a high investment for us. Nevertheless, it's an investment, but we do expect that the NHS will come online.

40:17 But you're right to ask the question. There will come a point if we don't get engagement with the NHS that we need to think about, you know, kind of coming back on that. But I'd like to believe that for all the right reasons, they'll find budget and they'll use our product. It's by far

40:31 and away in the work that we've done both in the studies, the pilots, and the testing that's currently going in the North Of England. It's by far and away a step up significantly from where the NHS is so for all those reasons both cost improvement in testing and faster turnaround they should take it And Tom's second question is, do you have enough cash to execute? Are you where you want to be post listing, not including the poor share price? Yeah. I mean, you know, the the we can't do a lot about the market, but what we can do is make sure we deliver and that's what we're doing. And deliver as effectively as we can at as low a cost we can and make sure we deliver so that we keep cash in the bank as long as we can too and kick it out further in terms of that cash runway.

41:17 And that's what we're doing by generating and pushing early in the market next year with lipid and code. We are where we expected to be in terms of I mean, obviously, the the MSIP process pushed things back with the FDA, but we're now getting back on track there. Liberty code is coming quickly. So in terms of delivery, yeah, we're pretty much where we expect it to be one year, just over a year in from the IPO. We've got a strong cash position. And on the basis that we deliver over the next six months what we expect to do, we'll be well ahead then. We'll have cash in the bank and we'll have delivered against what we said in the IPO. Would we like more cash? Not not. We don't need it at this point. We need to get on and deliver. But in the next six months on the other side of this delivery and products moving in The US market, we'll be in a complete we'll be in a quite a different position as a company. We'll have revenues flowing and we'll be in a strong position to then decide what we do as a next step.

42:13 It's not the revenues that will come online next year probably not going to be sufficient for us to keep pushing that revenue line back, the cash position back. But at least it'll give us a lever into the market and the beginning of that as a thought process. Now we'll see how things go because there's a lot of other irons in the fire with maybe pharma coming in and other things that could happen. So keeping the revenue streams open, driving hard, keeping the cost tight and making sure that cash burn is minimized and driving on with the revenues is key to what we're doing next year. That's the plan. Okay. Megan has a question. What are the biggest challenges that you foresee over the next six months?

43:02 Well, mean, this challenge is everywhere. Mean, it's not. If you look at what we're doing, we're taking an FDA process through, we're launching products into The US, we're building clinical labs, we're looking for regulatory approval, we're launching in The UK, we're looking for commercial every line, every strand that I've talked through is tricky and difficult. They're all a challenge. Not one more than the other. I mean, the one that's the biggest challenge and biggest value is the FDA. But at the same time I feel that the pathway we're on and the structure we're following with them is really well engineered. We've got a great team that is supporting me and the rest of the group in pushing this forward. We've got some fabulous physicians in The US who are really well placed to help make sure it's a fair game with the FDA and also that it's taken up swiftly and sensibly in The US healthcare system.

43:53 So maybe because of the kind of risk and return that's perhaps the biggest challenge but no, mean they're all challenging in some ways. Okay. That's that appears to be all the questions. If there's not any other questions, I'll hand back over to Paul. Fantastic, Paul. Thank you very much indeed. Thanks for covering all of those off. And of course, any further questions that do come through, team the will be able to run through those. We publish responses where appropriate to do so on the investor meet company platform. Just before redirecting investors to give you some feedback, Matthew, if I just may ask you for a few closing comments, please, and we'll do that. Yeah. Thanks Paul and Paul. Yeah. Just to say that we are we're in a really strong and interesting position and over the next few months we'll be delivering significant milestones in terms of planning.

44:43 So very exciting. And, yeah, I mean, we're we're I think we're well placed with, you know, a lot of hard work ahead of us. But hopefully, that the presentation has made that pretty clear and also the clarity around the steps that we're gonna engage to deliver that. That's fantastic. Matthew, Paul, thank you very much indeed for updating investors today. Can I please ask investors not to close the session? It should be automatically redirected to provide your feedback in order the management team can better understand your views and expectations. This will only take a few moments to complete, and then that's 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. That concludes today's session. Thank you, and good afternoon to you all.