Genincode (LSE:GENI) — Final results presentation

0:01 Good afternoon, ladies and gentlemen, and welcome to the GENINCODE Final Results Investor Presentation. Throughout this presentation, investors will be in listen only mode. The questions are encouraged and can be submitted at any time using the Q and A tab situated on the right hand corner of your screen. Please Just type in your questions at any time and press send. The company may not be in a position to answer every question it receives during the meeting itself. However, the company review all questions submitted today, and we'll publish those responses where it's appropriate to do so. Before we begin, as usual, we'd like to submit the following poll. And if you would give that your kind attention, I'm sure that the company will

0:32 be most grateful. And then I'd like to hand over to Matthew Walls, CEO. Good afternoon. Thank you, Mark, and good afternoon, everyone. Welcome to the Investor Meet company annual report for 2021 on accounts. We've got quite a bit to cover and talk through. So we'll move at a fair pace and look forward to taking questions at the end of the presentation. So just to remind people who are not familiar with the company, we listed on the LSC AIM market in July 2022. This is the first formal reporting period of update, and it's been a very busy past nine months.

1:19 Today, we've also made an announcement that went out this morning at 07:00 on the stock exchange, which was quite a comprehensive assessment of what the company has achieved over the past period since listing. But we'll touch on most of those points as we walk through the presentation. We'll start with the Board introduction, a quick flip through that. We'll talk about the key highlights to the company and what we've progressed and developed and delivered in 2021. I'll remind the group for those who are perhaps somewhat familiar and those who are new about the company's background in terms of its product range, portfolio. We'll major on The U. S. Strategy, UK and EU strategy. And whilst we're not a COVID based company, we'll also have a short update on COVID towards the end of the presentation. And Paul will run through the financial summary and then we'll finish on an outlook.

2:14 Okay. The Board, not a lot to add to where we came in through the IPO, although there have been some additions to the Board. David Evans stood down as Director early late last year, I think early part of this year. Huen Gray stood up as one of our new NEDs and Felix Frew. Hewen has a strong background in the NHS, ex Clinical Director for Cardiovascular Care. Felix joined us as an NED with a strong background in entrepreneurial based companies based on the West Coast in The U. S. He's also an ex FDA advisor too. So we complement the board with two new additions. The executive teams remains as is. And Bill Rhodes chairs the company together with Sergio Oliveira as NED.

3:05 Just by way of an introduction to the company, we're a clinical genetic diagnostic company, mainly focused in the area of polygenic risk assessment. That requires not only the wet lab understanding of how we work with genetics, but also a lot on in terms of bioinformatics and assessment algorithmic assessment of risk for patient assessment. We look at we're a revenue generating company and our products are commercially ready and selling now in Europe. We're still building out and positioning our company products in The UK and expanding now into The U. S. The products are CE marked here in Europe, and we'll talk about what's happening in The U. S. With the FDA shortly. We have a significant amount of investment in the company since the beginning of 2007 when we are part of the Ferro Pharmaceutical Group.

3:58 We also have a lot of evidence base behind our products working mainly with on the West Coast with Kaiser Permanente. And again, today we announced an expansion and extension to the collaboration that we have with them. We also have IP protection on our core products, that's Cardio Encode and Thrombo Encode. And also that leans into Lipid Encode where we use Cardio Encode as part of that product. So we have multiple product offerings. The products are coming through now in terms of revenue generation and growth. And the main focus of the company is in cardiovascular disease, simply because it is the leading cause of death worldwide. It accounts for most deaths annually. It's about twice that of cancer. It's a significant growing problem globally.

4:44 Most importantly for us, at the moment, the standard of care for cardiovascular disease does not include genetic risk assessment. So we have a strong advantage in the market as we bring our products through. There's a lot of education required and physician experience understanding as to how to use the products. So increasingly, you'll see as we go through the presentation, there's a lot around how we're now taking the products into market and getting physicians comfortable and understanding as to how we operate. These are the main highlights from the annual report and update. Some of these were completed in 2021 and obviously some of them more recently in the announcements today. So just in summary, we completed the IPO and successful admission in July of last year.

5:32 We were invited by the FDA to make a pre submission at the end of the year. So in December 2021, we made that initial pre submission. And I'm pleased to say that following very structured and full discussions with the FDA in the past few months, we will be making our full filing in the second half of this year. We also announced in the first half, just prior to the IPO, the Evarsana collaboration. So that's our commercial integrated commercial service provider in The U. S. We work very closely with them on a day to day basis. And that's the team that will commercialize our products in The U. S. Market. We also recently announced the Indiana University collaboration. This is with the School of Medicine, the largest medical school in The U. S. And associated with Indiana Health. They'll be taking our products in terms of risk assessment for cardiovascular disease, and we'll talk a little bit more about that in the main body of the presentation.

6:26 We also announced the Royal Brompton and Harefield NHS collaboration for lipid encode in FH, familial hypervestulolemia. And we also announced at the beginning of this year the completion and publication of the NHS positive results for LIPIDENCODE, which again has started to align us with NHS implementation. Again, we'll talk about that in a moment. And then following on from that, we undertook a pilot with the Northeast HSN, so that's the North Of England, Cumbria, Northumberland, Doncaster, Sunderland. They are the main center of excellence for work around FH in The UK, And we'll give you an insight to some of the work we're doing with them too.

7:11 That will be the main point of implementation for us to start with here in The UK, working with that group. Full year revenues grew a little, not significant at this stage, but growing and we're certainly seeing an uptick at the beginning of this year from our European business, which is where the predominant amount of that revenue comes from. Cash balances at the end of the year were pretty solid. And for those who are familiar, we raised having raised GBP 17,000,000 at the IPO, we've been able to hold the level of spending. We're not spending at quite the same level we expected to at the IPO, simply because the reimbursement for Cardio Encode has been moved back. And as a result of that, we're spending at a lower rate.

7:58 Recent developments, so announced today, we'll talk about the Kaiser Permanente collaboration. We're also setting up our own U. S. CLEAR lab in Irvine, just South of Los Angeles. Pleased to announce that Bupa Cromwell Hospital, that's the main West London hospital for private patients here in London. We've signed an agreement with them for FH and that signals the first revenues for The UK. And then finally, yesterday, when we put this presentation together, we hadn't expected to get the publication through, but a publication came through yesterday for our first COVID-nineteen study on Thromboencode. So we'll take a look at that towards the end of the presentation. So just by way of a quick introduction, these are the core four products in the company.

8:48 The Cardio Encode, Lipid, Thrombo and SUD, all of them have regulatory approval. All of them are selling and revenue generating in Europe. And moving across into The UK, we now have lipid encode coming on stream. So revenues are starting to begin to build with lipid encode. So we're excited by that. That's been a good move since we came into IPO. And similarly with Cardio Encode, we expect that later this year that should also start to advance begin to advance in The UK market. But the main focus, a significant amount of our time and efforts focused on the FDA in The U. S. Cardio Encode is the lead product. And we expect that by beginning of next year, half one of next year, that we should receive regulatory approval for Cardio Encode. Lipid Encode is also coming strongly. There've been some changes in The U. S. Market around reimbursement, notably with the CMS advising that a number of states now will receive reimbursement for FH testing, that's Lipid Encode.

9:47 So we're accelerating Lipid Encode through partly as a result of the delays in cardio ENCODE on the reimbursement side, but also because we have a particularly competitive product in this area. So we'll talk a bit about that too. Thrombo ENCODE, again, we've planned an emergency use action based on the good work that's been done around COVID. We've got another study that's coming through over the coming months, but we'll likely wait for that to be completed before we decide to move thrombotic code forward. So we have a number of irons in the fire, a strong portfolio growing and now obviously revenue generating will starting in The UK and extending into The U. S. Okay. Again, a quick summary. At the highest level, we take samples of blood or saliva in the sample collection and report those DNA based results back to physicians.

10:37 So in simple terms, not dissimilar from the process by which COVID sample collection takes place. Behind the scenes of the laboratory, what we do is undertake to extract DNA from the samples provided, undertake genotyping and sequencing, work through our bioinformatics algorithms and then provide clinical reporting back to physicians. They can then go forward with an effective or more effective treatment approach for patients. In addition to doing that, to do that effectively, you need your own bioinformatics system. We have our own infrastructure to deliver that. It was part of the acquisition made from Ferra Pharmaceuticals back in 2018. And the FITAB system is the backbone to the way we deliver our products into the market.

11:27 Okay. Again, in terms of a as we move towards The U. S. Summary, this is a view of The U. S. Market just to give the group an understanding as to why we're focused in cardiovascular disease. It affects a significant proportion of The U. S. Population, around eighty six million Americans who are living with cardiovascular disease at various stages of onset, which is a proportion of the population is significant. It accounts for nearly a third of all deaths And as a cost to the nation, both in terms of mortality and health, but also in terms of economics, it's a significant burden. And it's set to grow significantly over the next ten years.

12:15 So in terms of our U. S. Strategy and the way we're taking forward cardio and code, we announced the collaboration with Evarsana Health. The process by which we work with them, we work very closely on a day to day basis. We've focused down on a small core team by which we work through in terms of developing Cardio and Coat, partly because originally when the CMS had not repealed the M SIT process, we intended to launch the product a little bit faster than has been. But then in September of last year, CMS announced that they would repeal the M SIT process, which has put the process of getting reimbursement for cardio and code on a slower pathway. As a result of that though, it's meant that the burn rate for the company is therefore reduced.

13:02 But in some ways, it takes it back into a position whereby and one which where I'm more familiar, the MolDX process by which we can look to gain a firm process of working reimbursement through the CMS, the MAC base, that's the Medicare administrative contractors work through the process of gaining reimbursement in that more tried and tested method. So the MSIP process hasn't gone ahead. It was repealed by the CMS. And as a result of that, we're now following MolDX. In terms of the regulatory FDA process, we were fortunate last year that whilst COVID was still a major pressure on The U. S. Healthcare and especially the FDA, the value of what we're doing in terms of diagnostics for cardiovascular disease is significant, partly because of the market that we've just talked through. But in terms of addressing it, the clinical risk assessment has been little changed over the last twenty, thirty years.

14:02 And whilst there are there have been advances, genetics is still not a key part of risk assessment for cardiovascular disease. So in discussions with the FDA, we made great progress around the value and the benefit of bringing Cardio and CoDE through. And what they have done more recently, certainly in the last few months, have been very helpful in guiding us and presenting us with a clear pathway by which we can now make our full regulatory submission, which we expect to make in around quarter three of this year. So over the next three, four months, we would hope to make that submission. Roughly speaking, that submission is made, it will take around six months to gain full approval from the FDA. But the pleasing thing is we have a close relationship with them, a structured program by which we'll deliver the full regulatory submission.

14:52 And they've been very helpful in guiding us in the right direction. Moving then through reimbursement, I've just talked through the MolDX process. It won't be until next year until we file the MolDX program that we can then start discussions with CMS for reimbursement. Bearing in mind, Cardio Encode is a novel product. There isn't a product similar to it in The U. S. Market or for that matter globally. It brings a significant amount of value over and above clinical risk assessment. And what we're now starting to do is start to position it with each of the institutions that I mentioned a little earlier. We'll talk through those in a moment. Commercial operations are setting up our own ClearLab in California out of Irvine, just South Of Los Angeles.

15:37 And that will be our own ClearLab. It won't be a partnered ClearLab. That will allow us to invoice directly from the ClearLab for work undertaken in relation to GENINCODE. So GENINCODE will have certification for the products we build out of that lab. At the moment, it's being commissioned and set up, and we expect by the end of the year to be able to provide Cardio and Co and Lipid and Co products on a research use only basis. Early discussions with pharma. So we've mentioned this briefly at the last update. Those we expect those discussions to move on. There's a little bit of market assessment work going on with a number of pharma groups. And we're also talking to them about the work we're doing on lipid encode two. So very focused, very clear.

16:22 And the difference between where we were when we came to IPO and where we are now, whilst we were to deliver these things, these things are now being starting to be delivered and we're moving into a structured pathway by which by delivering on the plans we have, we engage reimbursement and regulatory approval.

16:41 Okay. So these are the three core groups that we're working with in The U. S. All of them in their own right significant institutional groups. The clinical utility work, so this is primary care physicians in the New York State, a subset of them selected for taking CARDIO ENCODE. And our intention is therefore to have them broken into like a randomized trial whereby some of the physicians and patients will receive CARDIO ENCODE as a test, others will not. So that what we're able to do is look at how the product is received in terms of the patient's receipt of the test information, their adherence to therapies and importantly from the physician side, how they can look at changing their therapy and treatment perhaps intensifying it or in those patients where they've identified a patient at high risk moving them into treatment. So starting a treatment pathway. So that's a crucially important study for us. It's with one of the biggest healthcare groups in The U. S. And based in and around the New York State Quality Care Group and the primary care physician network. There are about 35,000 primary care physician network in that network, but it will be a small subset of that who we will work with.

17:58 And from that, that will then yield the clinical utility work. That will then go into our MolDX submission and allows us to show not only the clinical validation of what we're doing with Cardioincoder's product, but then also the utility, the value it brings to the physician on the front end in terms of day to day physician treatment and patient outcome. The clinical validation studies then with Kaiser, we've just extended and announced today the expansion of our Kaiser Permanente collaboration. We've been working with them for the last five, seven years now. We started in back in 2014 with the initial studies on the European ancestry cohort and then more latterly with the ethnic cohort. Just so the group are aware, you have to work with significant population numbers to be able to deliver a significant powering and also clinical validation of the Cardio and Co product.

18:54 In the case of these studies, we start with data sets, which have around 100,000 patients. So Kaiser Permanente is a key partner for us. And also it's an integrated health care system in its own right. So it provides coverage for all its patients and lives covered. So that's a good collaboration for us in terms of both the clinical validation, but also as it extends on to further utility and expansion of the collaboration as we move forward. So they're based on the West Coast and NYP, New York Presbyterian based on the East Coast. And then in the Midwest, Indiana School of Medicine, the largest school of medicine in The U. S. We have a strong collaborative relationship with them. We announced that they would be testing Cardio Encode for risk assessment of cardiovascular disease alongside testing with CT scoring and imaging. That tends to be a very often used process for looking at risk assessment for cardiovascular disease.

19:53 But the jury has been a little bit out over the past maybe ten, twenty years now as to how well it correlates with the onset of cardiovascular disease. We believe that, that coupled with a genetic risk assessment will bring a combination of two different technologies, which will advance the CT scoring and imaging as well. So those are the three pronged approach that we're taking in The U. S, West Coast, Midwest and East Coast. And all of those in their own rights are significant institutions. Kaiser, for example, are about roughly the same size as the NHS, and that's mainly around the California and West Coast states.

20:37 Okay. So then we move on to this is the timeline for regulatory and reimbursement for Cardio and Co. So you can see at the top half of this slide, we've had we're invited to make the pre submission filing at the end of the year. In March last month, had previous month we had at the beginning of full discussions with the FDA around how we go forward with our regulatory submission. They were very pleased, good discussions with them. It's more of a relationship based approach. I think now we can at least talk to the FDA on an approach whereby if we're not sure, we feel that we can at least consult with them rather than last year, which was a little bit more at arm's length. So I'm pleased that the progress that we've made towards a more engaged relationship there.

21:29 In terms of the full regulatory submission, we expect to make it in quarter three, which will mean that approval should come through between quarter one, quarter two of next year. On the reimbursement side, it won't be until we filed the full regulatory submission, so later this year, that we then, beginning of next year, start discussions with the CMS on pricing. It's also partly as a result of the clinical utility work. The clinical utility studies will probably have follow-up. So we'll have information coming from them roughly six months after the utility studies have started. And that will then pour into the process for looking at reimbursement and pricing coverage. So not until first half of next year with CMS pricing.

22:15 And then beyond that, once we get through a little bit more data on the utility studies, we can make that as part of the MolDX submission. More the workhorse of getting reimbursement and more the standardized approach to it. The old MSIP process that we hoped would come in has been repealed and whether it returns, it's difficult to say. So rather than rely on that, we've decided that we're going to push forward with the MolDX process. Okay. Just to remind the group about the market opportunity. So there are around eighty six million Americans living with cardiovascular disease. And of that group, roughly speaking, one million of them been identified at low risk or intermediate risk.

23:00 And the problem with that is that's based on clinical risk factors. It doesn't include any genetic risk. And the concern there would be that those individuals who are at high genetic risk are not recognized within that population of 21,000,000. So that is our core and target market in the first instance. That's where we'll be moving Cardio and CoDE two. The second point is once the product receives approval, it then becomes pretty much a first in class. There isn't anything else in this space for genetic risk assessment of cardiovascular disease. It then allows the likes of the American College of Cardiologists and the guideline processes to start thinking about risk enhancement and improvement of risk assessment by using genetic tests once there is a product in play. So we'd expect the guideline changes over the coming years.

23:50 And beyond that, I think further out, we then start to see that rather than full focus on clinical risk factors, genetics becomes a bigger part of cardiovascular disease risk assessment. It's definitely coming, but at the same time it needs to be delivered in a very formal structured way. So we think by the work that we're doing with Kaiser, NYP and Indiana Health that we have a very strong group and support from those institutions. Okay. So just moving on to lipid encode. So as a result of the M SIT changes, we have decided to accelerate lipid encode, partly because we have now the ability or given the fact that the Cardio encode is on a slightly slower track for reimbursement, it's allowed us the opportunity to and also some changes by the CMS to accelerate lipid encode.

24:48 So the CDC, Centers for Disease Control and Prevention in The U. S. Have classified FH testing as a Tier one genomic application. So a significant positive impact on public health. In addition to that, there is a growing recognition of FH and its importance to risk assessment in cardiovascular care and we're in discussions at the moment with the FH Foundation around that. And importantly, there is now there are a number of private groups who are covering FH testing. And it has a particularly attractive clinical lab fee schedule price of around $1,200 plus. So it's slightly maybe higher than that in some instances. Importantly for us also, the CMS at the beginning of this year, they nominated a number of states who they saw as being capable of looking at reimbursement.

25:39 So whilst 80% of the market is private base covering off the Aetna's Blue Cross and

25:44 so on, Kaiser as well, there is still that 20% of reimbursement that is helpful to go forward too. So it looks as though the CMS are also starting to change tack and MACs are starting to look at reimbursement on a state based or Medicare based approach too. So as a result of that, we're accelerating the program for lipid and code, set up and launch at our CLEAR lab out of Irvine in Los Angeles, just South of Los Angeles, working up with the key foundations how we can approach lipid and code testing and importantly starting what we're calling a physician experience program where we can bring them up to speed with lipid encode. Importantly, just so the group is aware, FH testing is for our product has a number of dimensions to the way we deliver the result. There's not only a monogenic risk assessment, which is traditionally where most of the testing for FH is undertaken.

26:42 But in addition to that, we have four other areas. We do a polygenic risk assessment, which looks at the ability of the patient to metabolize cholesterol over and above the monogenic risk assessment. We also have a cardiovascular risk. So we build cardio ENCODE into the lipid ENCODE test. It also looks at a variant Lp and the presence of that within the test for the individual and also for statin intolerance to ensure that in the case of simvastatin that the physician is appropriately giving the right treatment for that test. So the test we provide is both important in terms of both the FH testing, but also where a patient is negative for testing.

27:27 It also provides significant insight over and above other testing as to the risk associated with maybe not positive for FH, but risk associated with cardiovascular disease for that patient using lipid ENCODE. And that's vitally important because in a lot of instances when you're testing with lipid ENCODE, the patients are not always positive. They're very often negative. And therefore, it's important to provide the physician with that insight. We believe the physician experience program will accelerate their understanding in the area as well as give them a tool which they can more effectively deliver treatment to patients. Okay. And here's the timelines for the regulatory position and also for coding pricing and reimbursement.

28:13 Now the good thing is because we have reimbursement with private and now CMS coming, it means that if we can quickly start to scale up the product in The U. S, which we are now doing in our ClearLab in California, then it gives us the opportunity to move the product into market on a soft launch basis in quarter four of this year. And then together with our colleagues at Evarsana

28:36 on the assumption that, that starts to gain significant traction, which we expect it to, then we'll be looking at a full launch probably around quarter two. And that really brings then the sales teams back in and the engine room of Evosana's commercial teams to really drive growth in the market with lipid encode. So and then moving to the bottom half of this slide, on the reimbursement side, what we have we can see that CMS coverage is now beginning. Private coverage is there in place too. The basis that we can move through the soft launch process with the physician experience programs, we'll start the discussions with the commercial private payers. So underlying and underpinning all of that is the physician education programs. Okay. Again, to give an insight to what the value of this market is, it's not as big as the cardiovascular disease market in the round, but it's nevertheless a very significant and a useful market for us given its tailored approach to what we have as lipid encode as a product.

29:40 It accounts for around about $1,000,000,000 But as you can see from this slide, it's significantly underdiagnosed both in private terms commercially and Medicare and also other and some of the pharmacy benefit managers as well. So it gives us a great opportunity to move quickly, gain reimbursement and set our product up not for FDA approval, but in this instance for as a lab diagnostic test. So we're very excited and it's aligning now very powerfully with what we're doing here in Europe, which is also finding similar appeal with The UK, with the NHS and also it's our biggest product in sales terms in the European business. Okay. Just to come over to The UK.

30:27 So we announced early part of last year the collaboration with the Royal Brompton. The early part of this year, we announced the successful results from the work we've done with the NHS the comparative study.

30:40 We're now we also announced that we'd be setting up a test pilot. I can tell you that that has been successful too. So we're into discussions on implementation with the Northeast Of England. I'll come to the market opportunity in a moment. And we've also just announced today that the Bupa Cromwell Hospital, the largest private healthcare hospital here in London is also covering

31:04 the private care on that side. And that's a significant opportunity for us too. That's around about GBP 800 a test, relatively small numbers by comparison with NHS, but nevertheless, a good revenue growth for us as the test gains traction in The UK market. I touched on the case study last time we talked, so I won't go back through that. But just to say that in terms of the drive for lipid encode in the NHS, the NHS has set out in its ten year long term plan a number of targets, one of which key for cardiovascular risk and prevention is the target of twenty five percent or identified twenty five percent of The UK population who are suffering with FH. And as you can see from that bottom right hand corner box, at the moment, we estimate that the NHS is way behind target in terms of where it needs to be and it's probably near around seven percent against a target of twenty five And part of that is to do with the fact that the lab groups up and down The UK on behalf of the NHS are working in a on a hub basis, so they work in separate regions of The UK.

32:15 They do it in a disparate way therefore. They don't have access to a bioinformatics hub in the way that we do for lipid encode. So we have an opportunity to support the NHS and help them achieve those targets. And the way we intend to do that is this is an extract from the North Of England, AHSN. This is the core center of excellence for FH growth and testing here in The UK. A lot of progress has been made in this area, this region. We've been working closely with them since we got the positive results from our FH study in the NHS. We've completed the successfully the pilot work with them. And now we're looking at the introduction of this in terms of implementation with them and for them so that they can underpin and deliver the NHS targets.

33:03 And the numbers are significant. So this area of the North Of England accounts for about 3,100,000 people. It covers off 73 primary care networks. And at the moment with their existing processes, they are currently identifying. So they work through a screen based process to try and identify patients who are FH positive. That usually means that they roughly get around at best about one in three of the time. So that means three tests undertaken to find one positive individual. If we were to use that, then that would mean around about 38,000 tests would need to be undertaken to deliver all of the positive patients in that region. Well, at the moment, they have to get 25.

33:52 So we're looking at mechanisms and ways by which we can deliver lipid encode to this area so that they can meet their twenty five percent NHS target. And importantly, from where we are and what we're doing now in The UK and with the NHS, we can see that having done this and worked this through with the Northeast, this puts us in a strong position to domino effect into the other areas of The UK. So this is our main group. It's the way we spend most of our focus and time to get it right. And over the coming months, we expect to move on from where we have on the pilot into a phased implementation to achieve the NHS targets with this area and then beyond that for the rest of The UK. So it's an exciting time for us, and we're very pleased with the results we've seen to date.

34:41 In addition to that, there's still a lot of education to be done and this is an extract from some of the educational literature that we're now sharing with the institutions we work with. This one's from for the Bupa Cromwell Hospital. And it explains to both the patient and also to physicians the importance of FH, but mainly for patients so that they can gain an understanding as to how important it is to recognize FH testing. And it's also, like I said, it's a key pillar of the NHS long term plan. And we in terms of this pillar, can we now have a mechanism by which we can help the NHS deliver that. Just turning to Europe. So Europe has been where we started the company out of Spain.

35:27 So we acquired the two companies from Ferra Pharmaceuticals in 2018. The Spanish group together with Italy have been the main revenue generators for the company, certainly since we took over control from Ferra. And more recently now, we're looking at rolling out Cardio Encode into the Spanish regions, Andalusia and Catalonia. On a similar basis to what I've talked to earlier around intermediate low risk individuals currently classified on a clinical risk basis. But once we run our genetic risk assessment against them, can start reclassifying those individuals for more appropriate treatment, whether it be more intensive or starting them on new treatment. We've also been building strategic alliance with some of the other key groups and collaborators in the region. So we announced last year the Cinelab and Longwood collaborations.

36:16 We expect those to see more growth this year. We signed them in the second half of last year. So this year they should start to kick in. And we've already started to see a little bit of an uptick now in the European business post the last year with the still the effect of COVID. We're also exploring new EU opportunities with those groups. So I think the intention is to not only grow with Spain in around Cinlab and Longwood, but also we're looking to expand that perhaps further. We're expanding our sales team in Italy. So that's our at the moment in terms of market terms after Spain, Italy, we do a lot of lipid and code testing in Milan, and we're looking to expand the team there. And then more recently, with the results we've received on COVID-nineteen, we're preparing our product for COVID-nineteen for introduction to the Spanish market.

37:05 We'll wait for the next round of results to come from we've got another study ongoing, but before we think about that for The U. S, and I'll come to that in a moment. And we also have for our Thrombo Encode oncology product, we're looking at launching that into the market at the beginning of next year. I'm also pleased to say that along the lines of the Royal Brompton approach, we're now looking at a partner in Germany, in Dresden for the Saxony region of Germany. So Europe has got a lot of moving parts here, but firmly focused on revenue growth with the existing regulatory approval we have for these products. Again, just one slide on where we are with COVID. Like I said, we're not a COVID focused company. But importantly, we noticed a couple of years ago when COVID broke that there was a correlation between those individuals who seem to be at most severe risk and our Thromboing Code product for clotting and thrombosis.

38:04 And we're pleased to say that yesterday the first publication was made. And what it's shown is that there is a significant correlation between the risk of venous thrombosis and severity of onset of COVID. And that for us is again further evidence that we're moving in the right direction. The Thrombo Enco product is not a new product. It's taken us ten years plus to develop, but it was focused on the hematological side, clotting in general, the hematological clotting in thrombosis. But in this instance, it overlaps significantly with hypoxia and certainly the end of life end stages of life in the ICU. So we saw in the study significant numbers of cases with a high level of risk by thromboing code.

38:53 We also saw a significant number of cases who had mortality and death at thirty and ninety days, who were also high risk for venous thrombosis. Now there's more work to do on this, but in terms of early indications on what is relatively seven fifty patients in total in this study, it's a relatively small study, but it's a very good indicator of the next steps for us. So we have another ongoing study in Barcelona that will then once we get the results from that through, we expect to then position ourselves as to a more broader product. But in the short term, medium term, we expect to be announcing this with the Sao Paulo Hospital over the coming weeks and it will bring greater profile to this as a product moving forward.

39:37 Okay. I'll hand over to Paul, who can walk through the financial summary for 2021 and give an update on where we are. Thanks, Matthew, and welcome, everyone. It's quite a simple set of financials. Just to recap, we have GENINCODE PLC as TopCo, which owns 100% of GENINCODE SLU, which is our trading business in Spain. So we have two small offices in Barcelona. And PLC also owns 100% of GENINCODE U. S. Inc. In preparation for our U. S. Operations. So quite a simple structure. So to recap as well, we listed on AIM in July 22. We raised £17,000,000 gross. That's £15,300,000 net. And just on the financials, to clarify, pounds 600,000 of that £1,700,000 listing fees was expensed to the P and L and and the remaining GBP 1,100,000, well, it's just a balance sheet movement and allocated to share premium.

40:37 Revenue is up 20% from GBP 1,000,000 to GBP 1,200,000. Modest revenues, but more importantly, it's proof of commercial traction and the product selling in the Spanish speaking markets. So demand was still slightly suppressed with COVID, but I'm hoping we're hoping that's going to fully recover in 2022 and beyond. Trading to date for the first four months is up against budget and up against last year. So we're starting to see even more recoverability during the months of 2022. But in terms of that £1,200,000 revenue, where did that come from? So lipid ENCODE was our main product seller with around GBP $05,000,000 of revenues. That was up about 10% from the year before. Thrombo ENCODE, up to around GBP 400,000 of revenue. So that was the largest growing product in the year. And then that's followed closely by Southern Encode, which had about GBP 250,000 of revenue.

41:35 And the remainder revenue was a small amount of Cardio Encode. All the growth came from Spain, which represents about 90% of the revenues. So we've got a little bit of revenue traction in France, Italy and Latin America, but most of the growth in Spain. Gross margins reduced slightly down to 51 from 54% in the year before. It's partly to do with product mix, but also partly due to little bit of pricing pressure from our two partners in Spain. But we will be seeking to either internalize some of that purchasing or services or seek additional suppliers. But just to recap as well what we mentioned at the IPO was, Europe was probably the most competitive pricing in the world. So with the launch in The UK later this year, then The UK is probably slightly more generous in the pricing. So the margin should increase in The UK to around 60% plus.

42:37 And then The U. S. Pricing is the most generous market. So we should be seeing margins of 70% plus in The U. S. On our product portfolio, especially on the CardioRINCODE. Operating loss increased from £1,100,000 to £4,100,000 Three main reasons there. Listing costs, as I mentioned earlier, expense to the P and L was around £600,000 Evarsana costs kicked in during the year. So that was about £1,300,000 which was not there the year before. And then salaries was around £1,000,000 increase. That reflected a headcount increase from about 16 in 2020 to £28,000 at the end of twenty twenty one. Coming down to EBITDA, the main difference between EBITDA and operating losses, those listing costs of £600,000 plus we've got about £73,000 of share based costs for the first time as well.

43:33 Just briefly on the working capital. Just two noticeable points. Inventory, you'll see that we hardly have any inventory on the balance sheet, and that's quite a benefit of our business model. Around 60% of our revenues are from genomic service testing, which means we don't need to hold any inventory there. But also a lot of our kit sales are delivered directly from supplier to customer. So that benefits our working capital position where we don't have to hold traditional three, four, five months of stock. And a second point here is that the payables situation is up quite a lot, and that reflects our Eversahn, our deferred costs business model. So to recap, 1,300,000 expensed in the P and L. So of that, roughly 50% of that cost is deferred on the balance sheet and paid back to Eversana as a deduction from revenues on a commission basis once we start generating revenues.

44:31 So that's quite an advantageous position for us to be in. It means that Evarsana are incentivized and motivated to commercialize or assist in commercializing our product as quickly as possible and to get the revenues at a highest possible level so that they can recoup their investment into the company as quickly as possible. And finally, cash position, 14,600,000 at the end of December. Now that cash is now around GBP 13,000,000. So we've got cash burn at the moment of around GBP 400,000 a month. Extrapolating that and probably we'll be burning a little bit more, maybe GBP 500 to 600,000 a month. That means we on an extrapolation basis, we've got enough cash to last us till at least December 2023. I won't go through the financial slides. We've got those in the appendices, but please post me any questions if you've specifics on those. But I hand back to Matthew to summarize.

45:26 Thanks, Paul. Okay. So this is the news flow for the next six, twelve months from roughly where we are now. You can see at a glance what we've done just from the beginning of the year and what the key points are that we talked through. So I won't go back through those. But just as a glance, I think it's a useful slide to refer to. And then just to round up. So we're delivering on what we said at the IPO and some. We're moving as swiftly as we can to take advantage of what we have in terms of our product portfolio. It's advanced in terms of its genetic positioning. It's got strong clinical evidence base. And now through the work that we're doing with the FDA, we're putting ourselves in a strong position for our full submission. So I'm pleased about the progress we've made there despite the fact that the CMS and MSIP process was repealed.

46:21 We're also setting up our clinical utility studies with our key partners that will underpin reimbursement. And we're accelerating as a result of the fact that we can now lipid encode commercially so that we can position it for to access those reimbursement codes that we can see both on a private and CMS coming on a MAC basis too. We're delivering against the collaborations we've set up with IU, NYP and Kaiser and preparing for soft launches for cardio and lipid later this year. Importantly, to do that, we need to commission our ClearLab. So we're well on with that process. It will require us to get ClearLab certification as soon as possible for our products so that we can then prepare them to go commercially. But in the meantime, we will set up on an RUO basis to make sure that we can get product into the hands of physicians as soon as possible.

47:14 We'll complete and we're looking to complete our first NHS implementation with the North Of England with FH in line with what we've just talked through. And we're pleased about the ongoing Bupa relationship that's building too. Good to get when we wrote this, the publication hasn't been made, but it was made yesterday. So we're really pleased with the first publication. But again, it's relatively small, so we need a bit more on it before we push that further with perhaps The U. S. As an emergency use application for COVID. And we'll continue to build out our EU collaborations and increase year on year revenue growth. And then finally, throughout the whole process since we took the IPO through, we've been strengthening the team. And where appropriate, we'll consider synergistic acquisitions.

48:00 So we're in discussions with a number of groups, albeit at an early stage, but that will add a further strength to what we have in terms of our portfolio and offering. So that's it. I think if I can hand back to you, Mark. Of course. Do you want to kind of round up for questions? Yes, definitely. Thank you, Matthew and Paul for updating investors this afternoon. Ladies and gentlemen, please do continue to submit your questions using the Q and A tab situated on the right hand corner of your all via your Investor Meet company dashboard. Matthew, Paul, I've given you no time really, but that's my best attempt to give you a small break. But if I could ask you just to open up that q and a tab and if you would be so kind as to read out the questions and give a response where it's appropriate to do so, and I'll pick up from you at the end.

48:56 Sure. Thanks, Mark. I'll start reading out some questions. We've got about seven or eight, I believe. Mark has asked, I note the increase in admin expenses as you continue to grow. How many staff does the company have? And are there any based in The U. S? I think I partly answered that one earlier. We have at the end of December, we had 28 staff. Only one member was in The U. S. At that time. And that was our Chairman, Bill Rhodes. We have another couple of staff here in The UK now, so we're probably up to about 30 in total. But just to recap, that's probably one of the beauties of the Evarsana contract. Remember, Evarsana are working on our commercialization program in The U. S. If we hadn't used those and built up our own office in The U. S, we could have had twenty, thirty, 40 people out in The U. S. At this time and we'd be paying those people even though the FDA program is being put back a little. So that saved us a lot of money in terms of having this flexible contract with Evarsana, whereby we control what they perform, what work they perform and therefore how much we pay them. So that's why our cash runway is actually despite the FDA delay there because of the M SIT repeal. We've actually got a longer cash runway than we would have had otherwise.

50:15 We do intend to recruit maybe three or four people in The U. S. This year. As Matthew said, that's mainly going to be in our lab facilities in Irvine. Can you give a little detail on your partnership with Eversana? How big are they? Is there any exclusivity attached? And how are they remunerated? Do you want to take that one? Yes. No, I'll take that. So Evarsana, about 4,000 person group, they cover a whole range of commercial integrated commercial services. And when we say integrated commercial services, that's exactly the process that they want to set up. They want to integrate their contract services for commercial exploitation with companies like GENINCODE. They traditionally do it with pharma based groups.

51:01 But in the case of GENINCODE, we are the first group that they're working with on a diagnostic basis. And we've touched on it a little earlier, but just to be clear, we're able to turn up and turn down within a sensible level of lead time, the cost that we incur and we spend with Evarsana, which means for us as a program and a collaboration, it's both valuable to us so that as we move into the launch program, we turn it up for the sales teams as they come on board. But clearly between now and getting ready for that launch, we make sure that those costs are not being incurred. So it's just to finish off what Paul was saying earlier, it's effectively, albeit they're not on our books in manpower terms, we have almost the same amount or in fact significantly more in headcount availability to us by using Evasana in that way.

51:53 So they're a big group, mainly focused in pharma, but increasingly now in diagnostics. And they've done particularly well as a group over the past three or four years as they've grown. They've grown by acquisition and they have some strong private equity financing backers. And to add to that and how are they remunerated, it's basically as a third party service provider. So they provide us with a work program, which we sign off on and amend accordingly, and they would mark up their time and costs accordingly as a third party. Mark has asked, can you expand a little on the key investment you made into your commercialization program? Probably largely you've got anything else to add to that, Mick? No. Mean, again, it's primarily from where we were prior to the IPO, which had been predominantly European, a little bit into The UK. Now where it is, is predominantly U. S. Investment significantly since the IPO and obviously setting up The UK too. There's still a good investment going to Europe as that grows too.

52:58 But we've the lion's share of the new investment coming in has gone towards The U. S. To scale what we're doing there. Given that in simple terms, it represents perhaps 50 fold the size of any of the single markets here in Europe. How many FDA staff are there in the discussions? And how sensitive are things likely to be if one or more of these move to other roles? Well, we've worked with the same team since we started, the same FDA team. And I'd asked when we were working with them last year that what we weren't keen to see, what people moving in and out of and people passing the baton. I'm a firm believer in making sure we've got continuity with the teams we work with. So the FDA have responded to that. Were happy to work with the same team. Throughout the last twelve months since we've been having dialogue with them, it's the same team that we've been working with. So continuity of understanding, because it takes some time to get up to speed with what we do, it's vital that we don't have to renew that understanding with someone new to their team. So now they've kept it pretty core and focused.

54:05 There are in total about four people on the FDA side who we tend to work with, of which two of them are the lead the branch leads and then the main scientific assessors and so on. So all of that is working well. And I think like I said, I think over that period, we've built a good understanding of relationship with them, hope. So yes, we'll see how things go, but so far so good. Next question. Am I right in understanding that FDA approval for expected in the summer of twenty twenty three? Yes, that's about I would say that's about right, maybe a little early if we can, because we'll be filing in which we're to try and file in the third quarter of this year. Expect and we hope it will take about six months. So I think that's fair to say summer twenty twenty three.

54:54 It gives a little bit of latitude. But yes, I think it's about right. Can you say why the share price has dropped 50% since IPO? Yes. I mean, like probably everybody else, we're disappointed as everyone. I mean, in one sense, if you want to take it from a point of view of where we came in, there is no reason why it should have in any way reduced because from where we came in nine months ago in terms of what we've delivered and where we're going, it's only got bigger, stronger and better. So there's no correlation or sense in why it's dropped. Now at the same time at a macro market level, lot of things have come off, a lot of things have been so it's become soft as a market, especially in healthcare, it seems to having had its heyday in COVID, it's come off a lot in the last few months. So maybe that's a little bit, but I would like to believe and I still for me personally, I like to feel that we are doing enough to set ourselves apart from the macro and try and really deliver on what we believe is a very exciting product portfolio, a growth prospect and also that we're delivering firmly in line with that. So there's no reason why it should have dropped.

56:11 And there's every reason why it should have moved in the opposite direction. Now that said, we're equally Paul and I will be looking very carefully at the investor base. Just after we came through the admission, there was a bit of weakness. We had a few of the investors who were flipping stock maybe and that wasn't helpful because it kind of made things difficult for a period. But that then was sorted out. And by good fortune, we've got some solid investor groups behind us who mocked that up. But there's zero sense and there's zero reason why it should be where it is. So in the meantime, we're not going to fret and spend we're to get on with trying to make sure that when we do our bit to deliver. And secondly, we then look to see how we can improve on that. So increasing the investor base institutional support. This is the first time properly since we came through the IPO that we've effectively come back up for air to talk more so with some of the institutional investors.

57:05 Over the coming weeks, we intend to strengthen that ever more. And on that basis, I expect to see the share price recover. We to remind investors that market cap is GBP 23,000,000. We've got GBP 13,000,000 in the bank. So GBP 10,000,000 enterprise value. There's an awful lot of other health care companies out there with a hell of a lot more enterprise values than GBP 10,000,000. And we've got plenty of cash runway as well. Yes. So between now and let's say cash runway and we've got a lot of things we're to be doing and delivering. So we will add further strength to the story. And we'll I hope it might be like a bit of an elastic band, maybe it will rebound at some point in our favor significantly.

57:50 But when it does, then for those who've been part of the process and the journey today, we'll also have seen that the market can sometimes not act in a perfect way. But anyway, that's where we are. But we're on with programs to improve it and you can rest assured we'll be doing what we can to do that. Mark, we do have a few more questions, but I'm conscious of time. That's great. No problem at all. Obviously, any other questions that do come through, we'll make those available to you for your review post today's meeting. Firstly, thank you very much to all those investors that have submitted questions this afternoon and to you guys for your time in addressing those. Matthew, Paul, I know investor feedback is important to you both and I'll shortly redirect investors to provide you with their thoughts and expectations.

58:35 But I wonder before doing so, if I may, Matthew, just hand back just for a few closing comments, as I say, before I redirect investors. No, no. Thanks, Mark. Well, just to say to and for those who are on the call who are investors, thank you for all your strength and support and understanding. I think the one thing for me is that when you're dealing with a technology like this, which is significant in terms of its impact and will be, but it also takes time sometimes. I'm just hoping it's with us on that journey. But then the other point is for those who are maybe not investors, we look forward to talking to you in more depth. And if you want to follow-up with the company directly, then please reach out to us and we'll try and catch up. But no, thank you for all your help and support. That's great.

59:20 Matthew, Paul, thank you very much indeed for updating investors this afternoon. Can I please ask investors not to close this session as we'll now automatically redirect you for the opportunity to provide your feedback in order the management team can better understand your views and expectations? It's gonna take a few moments to complete, but I'm sure it'll be greatly valued by the company. On behalf of the management team of GENINCODE PLC, I'd like to thank you for attending today's presentation. That now concludes today's session, and may I wish you all a very pleasant afternoon.