ViroGates A/S ($VIRO)

Welcome, everyone, to this 2025 Annual Report Presentation and Q&A hosted by ViroGates. With us today, we have the CEO and the CFO of ViroGates. First, the company will give a presentation, followed by a Q&A session where they will address questions submitted live as well as those sent in beforehand. I will now hand it all over to ViroGates. So please go ahead.

Thank you very much, Anders. It's a pleasure to be with you here again. And hopefully, we can shed some light on our newly published annual report and also address questions. So I will begin the presentation and then Josephine, who's with us here today in the capacity of CFO of ViroGates, will present the financial parts of the report. And it will take approximately 20 minutes. So without further ado, a forward-looking statement that obviously go and read the report. If you have time for it, it's published by the traditional channels, if you signed up via our shareholder system or at NASDAQ. So ViroGates was founded in 2001. So we have spent quite a bit of time developing products and also developing clinical evidence to support what it is we are doing in daily life. We are headquartered in Birkerod, just north of Copenhagen. We are about 10 people. We listed at NASDAQ First North Growth Market in Copenhagen in 2018. And our mission is basically to support early risk identification and support this information conveyed to individuals as well as patients also in hospitals. We basically have a vision where we see the health care system shifting from the traditional reactive way of treating disease that has already emerged into something where patients take more and more -- or individuals take more and more responsibility for their own health and thereby using this information to lead hopefully better lives. The investment case that we have here with ViroGates is that we have a proven technology. We have manufactured products now for a number of years, various product ranges that we come back to. We have a global reach. We are CE-IVD accredited and well on our way to migrate to IVR. And then we are positioned for this longevity or health information boom that we are seeing where people take more and more interest in their individual health and try various whether it be [ X ] or maybe just the well-known advisers that we all know of smoking cessation, more exercise and so on and so forth. We have partnerships established with various players, and it's one of the things that we're looking to expand on during 2026. And we also believe that we have a regulatory momentum and the fact that we have already disclosed that we are working with the FDA to also introduce our products via the FDA route in the U.S. and more about that later on. suPAR is basically a protein that is present in the blood stream of everybody irrespective of our individual condition, but it rises in general with inflammation. So it's a marker of the immune status. It's not specifically related to any particular disease, but I like to refer to it as the sum of all evil. It basically captures the inflammation level and it's, we believe, best marker of providing an overall status of the immune system. We have shown in numerous studies that it's a strong predictor of chronic inflammation, and this is also what is depicted here on the left hand side, where we basically look at various levels of suPAR in an acute ward. And as you can see, the survival rates of the ones -- the patients with very high suPAR is very low. It's actually around 50%. So those are the patients -- the most critical patients typically admitted to the intensive care units. Fortunately, most of the patients are actually in the lower level, and that's where we see an opportunity also for early discharge. We'd like to focus a little bit more on our efforts in the preventative health and longevity space. And this is because we've basically migrated our strategy to focus very much on this particular segment. We have for a few years now, increasingly been targeting the health and longevity market. And this is a market that is still evolving and trying to find its feet, I would say, with a lot of players that are coming in to this overall market that is growing on a global level. It has to do with biological age where we have set up a system where we can basically convey a biological age in the form of the result of the suPAR where we measure up against a large cohort of people at the same gender and age as the individual having been measured. And thereby, we're able to say whether that particular individual is aging faster or slower than their peers. We can help identify the key drivers of leading a healthier life. We can see if that individual is progressing in the right way or maybe needs to take a different action and thereby also preventing the disease risk. A high suPAR level is always an indication of a higher chronic inflammatory stage. And some of the advisers that we convey are typically some of the ones that we already know. We know that smoking is bad. So smoking cessation generally leads to a lowering of suPAR. And on average, it's typically 1 nanogram per milliliter of plasma, which equates to anywhere between 10 and maybe 15 years of aging. So there's actually a very easy hack to lead a better life and that is quitting smoking. We probably already know that, but suPAR is a very tangible way of saying that the immune system actually rewards us from taking a different path in our lives. Same goes with -- if we exercise more, if we eat better, drink less and so on and so forth. So this is a very tangible and easy way to convey a message to the individual by the clinicians. What I mentioned before was this comparison of the low levels of suPAR and the higher levels of suPAR. This is depicted in a study here where we basically show the difference between an individual having a higher suPAR compared to a lower suPAR within their respective age. And as we can see, the one with a high suPAR actually is biologically 15 years older than the one with the low suPAR. So a very tangible way of showing the effects of lifestyle interventions. We play into a very large market. We obviously only address a subsegment of it because it comprises anywhere from food supplements and exercise programs and so on. But obviously, we are addressing a niche of this by ways of the testing of the overall relevant markets. What we're trying to do now and the reason why this is not a quick fix to introduce our products fast in the longevity market is that we aim to deliver more to our partners than merely a blood test. We like to illustrate by ways of the, for instance, the biological age that I mentioned that we basically conducted this large study, and we've been able to mine these data so that we can convey this biological age. This is something that we are refining all the time to be able to offer more services on top of the mere traditional tangible products such as our suPAR tests. So this is something that we typically offer as additional services to our partners. And then into our products and business model and team.

Yes. Thank you, Jakob. As Jakob previously mentioned, we have varying ways of measuring suPAR, which we all occupy ourselves with on a daily basis. We have the first product that was launched the ELISA on plate. That's primarily a research use or at least until not today, but the past years, it has been primarily research use because it makes sense if you have lots of volumes that you want to test at once on one plate. But it's also the product, and I'll come back to that, but it's a product that we see being used mostly within longevity where you want to measure even the slightest changes in suPAR level when you change your lifestyle. So that's the first product. That's ELISA. Then came the Quick Triage. That's another way of measuring suPAR. What differs from the ELISA is that the QT test, it's a near patient use lateral flow test. So you do not need to send off the blood for it to be analyzed somewhere else. You can actually perform the suPAR test in near proximity to the patient. And then lastly, we have our TurbiLatex product, which is for automated clinical use, so typically on these bigger platforms in the hospitals, supplied by Siemens and Roche, Beckman Coulter, Abbott, among others, where it makes sense to implement suPAR in this way since you can get very quick results when you ship off a sample from one department of the hospital into the main laboratory. And we'll come back to the POC+ later. We have commercial presence both through direct sales representatives and established distributors. As you see depicted on the page, we mainly have distributors located in Europe. We also have a distributor in North America. And then we have direct sales covering Europe and also research-use-only use of our products for the rest of the world. This is our management team and Board presenting extensive experience within health care and med tech. And then on to what today is actually about, which is the annual report of 2025. I think Jakob has also touched upon it and we will elaborate a bit further later, but '25 was a year of several defining milestones for ViroGates. First of all, we achieved a proof of concept for our suPARnostic POC+ targeted at the longevity testing market. Some of you might have noticed that, that was the fourth product on the product table I showed you before. And we also, in '25, received FDA feedback confirming that suPARnostic TurbiLatex requires a de novo pathway, ensuring that we give -- we have regulatory clarity going forward on that path. Then third, we deepened our commercial partnership with suPAR Bio in the U.S., which is our American distributor. And also the investment entity behind suPAR Bio made a public offering to the shareholders of ViroGates and thereby strengthened their commitment to the potential of the suPAR biomarker. We also raised approximately DKK 19.3 million in a directed capital raise towards existing major shareholder. And lastly, we took, as Jakob mentioned, significant steps towards EU IVDR. Looking to the numbers. Revenue grew 8% to DKK 5.3 million, driven also by the increased traction in the preventative health and longevity segment. So us experiencing that more customers are interested in using our products for preventative health and monitoring suPAR levels broadly. Our net loss was improved by 28%, down to DKK 10.4 million from DKK 14.3 million in '24, which is a reflection both, of course, of the increase in revenue, the increase in other income, which also includes the income from the Sobi collaboration and then an overall reduction in operating expenses. And then diving a bit deeper in, this slide shows the 5-year financial summary, which is also presented in the report. Only a few points or a few points worth highlighting is that other income, as I touched upon before, increased 60% to DKK 3.6 million, which reflects the Sobi collaboration that has been ongoing and is still ongoing on making TurbiLatex available in the U.S. Total operating expenses were reduced by 17%. This was mainly driven by lower sales and distribution costs also as a result of a reorganization we made in late '24. Our operating cash burn dropped from DKK 12 million in '24 to DKK 4.1 million in '25. And then you see also on the cash flow from our financing activities, it's reflected that we had a directed emission in November that raised the DKK 19.3 million, also ensuring that at the end of the year, we had a substantial strengthening of our cash position, ending up at DKK 26.3 million. Looking into the revenue mix, which is the table you have on the left side here, it's visible that ELISA is gaining space and gained traction, even more space in '25. ELISA has traditionally been primarily the product used for research purposes, but it's also the product that is sourced by laboratories that serves several smaller longevity clinics or preventative health clinics with testing. So it's also the primary longevity product that we have. If you look to the right-hand side, you'll see our recurring customers, which is the number of customers that in '25 have placed at least 2 purchasing order with a minimum value of EUR 10,000 accumulated. And it has remained rather stable, as you see throughout the year. And we're happy to witness that an increasing amount of these customers are within the segment that we are putting an emphasis on, which is preventative health and longevity.

Yes. And then the concluding slide is some of our focus points for -- well, the year that we've already embarked on. Obviously, as Josephine pointed to our POC+, which is our point-of-care plus product, indicating that it's an improvement over the existing Quick Triage because it only uses a fingerprint blood and not a spun sample of plasma. As was mentioned, this is still in development, and it is also today still in development in the sense that we initially launched it back a few years ago, but with a focus on triage in the acute care setting. We wanted this product to be even better. And therefore, we are with our partner, GENSPEED in Austria, trying to improve it. So it is more sensitive in the lower range. And this has required quite a bit of work, and we work strongly with GENSPEED to enhance this sensitivity of the product. And we will also, as a final result of that, do a clinical verification test where we basically test this product up against our golden standard, the ELISA. And then we aim to take this through the IVDR process, the new regulations for in vitro diagnostics, just like the medical devices that are much more stringently regulated nowadays. So this product will be available sometime late 2026 or maybe coming into early '27, depending upon the pending, the clinical verification and also the process with the IVDR. Fortunately, our partner has already taken one of their assays, one another product line for vitamin D testing through the IVDR process. So they have some experience with it, and we expect that they will do the majority of work because it's basically run on their platform. But we have obviously a commercial agreement for when we launch this product. And we will be looking very much forward to this because it facilitates the use of suPAR also in settings that we cannot penetrate today, for instance, potentially at pharmacies, GPs with low volume and so on that might be interested in the suPAR when it's facilitated in this way. Then we're working a lot with what we label our new distributor model. Traditionally, we've distributed our products by ways of existing distributors that had similar products on the shelves. We are trying to find distributors that have an edge within the particular market. And a good example that I typically point to is our newly established Polish collaboration where that particular individual had teamed up with a medical doctor, and they had good relations with one of the big laboratory chains in Poland. And therefore, we expect that we'll be able to penetrate this market with a much more scale because the products -- our products can be implemented by ways of the labs. So this is a tweak in -- rather than trying to seek sales clinic by clinic, if we can market it via one of the bigger lab chains, so it has more amplitude. Then we are also dividing a lot of time to our de novo filing for the suPARnostic TurbiLatex product. So with the FDA, we have to name one particular product line and also one particular indication, and this stems back from some research that we did during COVID-19. And we're presenting this file, hopefully, to the FDA during the first half of 2026. So a lot of efforts have gone into this, both from what is known as the analytical development level, but also from a clinical perspective because it is a de novo filing, which requires clinical evidence. So we have our hands full, but we are excited to see that that we are progressing, and it's slowly reflecting itself in the numbers, but we do expect this to be much more significant going forward when we see the fruits of all the efforts that we're making here. So those were the words. Thank you for your attention. And if there are any questions, I'll leave that to you, Anders, if you can take us through them.

Of course. The first question is from Peter. What would it take to increase sales faster?

Yes. I mean, if I had a silver bullet, I would definitely fire it. I think and believe that we are pursuing a strategy where we are analyzing each market for their particular characteristics. And as I mentioned, we had this -- we had this Polish distributor where we have a particular way to introduce in that market. That model would not apply in Denmark because the blood sampling and so on is done in a different way. And therefore, it requires quite a bit of work from our side to identify the market characteristics individually and also to then identify the right partners. So we're doing this as fast as we can. Obviously, we pay a lot of attention to the U.S. and the reason being, obviously, that it's more homogenous market. And it also has some characteristics in the form of the ability for individuals to seek knowledge about their health that we simply haven't developed to this scale yet in Europe. So a lot of strategic work and then execution, this is what we're doing. So I believe we are well positioned to do things as fast as we can, realizing that we are a small organization, but sometimes smaller organizations can also move more nimbly than the bigger ones. So we enjoy the fact that we can make decisions fast and apply them in the market.

And the next question is from another Peter. If POC test is finally tested okay, when do you then expect launch and which market segments will be addressed?

Yes. I think I mentioned some of them. There are some uncertainties. And I mean, the biggest uncertainty, I would say, is probably the clinical verification because we simply want products of a very high standard and quality. So we need to establish this and kind of like a pharmaceutical trial. You can't really do that until you have your final product formulation and have done all the initial steps. So we're looking very much forward to this. Hopefully, we can complete this before the summer or maybe during summer, and then we will need for the filing to go in. And the reason for my ambiguity in the response is that a novel IVR application is still something that is a new beast, so to speak, with notified bodies. There's been a lot of problems with scarcity of resources within the notified body segment. Fortunately, we have got one now. And as mentioned, our partner also has hands-on experience with taking it through. But those notified bodies are still finding their feet. And that's why traditionally, it has taken longer. We hope that we can complete something in 6 months. But it's probably something that we need to update on as we go. And the first milestone on the way would be a clinical verification that product actually performs satisfactory. And then we can plan the subsequent steps. So the answer, just to repeat it is, best case end of 2026, probably more realistic going into '27. And the addressable market will, as I mentioned, also be pharmacies and so on in selected markets and also lower total volume customers. And there are a lot of those that have an interest in suPAR, but basically have the limitations that they don't run enough samples and therefore, don't really have the necessary relationships with labs and so on. So we believe it will be quite a bit of a potential game changer and something that we will carefully also evaluate how we best market this.

And the next question is, have you seen evidence that your longevity sales are indeed recurring and not just one-off sales?

Yes. I can answer that one. Yes, it is fortunately the very short answer. We have seen that longevity customers or customers within preventative health are also returning customers of ours. They are also some of the customers that count in our measure of recurring revenue or recurring customers that I presented earlier. They take various forms. Some of them are smaller clinics that serves clients directly. Many of them, fortunately also since they have scale, they are larger laboratories that serves multiple clinics. So they don't necessarily have the direct client contact, but they do the analysis on our kits for the clinics that have the client contact. So yes. a bit long and medium, long answer.

And the final question, you mentioned the de novo application for FDA. Earlier, you have also mentioned that it could be called 510(k). What is the difference? And why do you no longer say 510(k)?

Yes. The reason why we talked about a 510(k) as it's known in the -- with FDA lingo is that's the section in the code that is referenced to. But that is a way of registering a product if there is a product already existing known as a predicate device. Typically, if a particular diagnostic test measures the same protein, for instance, and just is conducted on a different platform or maybe even at the same platform, but by a different company, it's easier to reference to that file. So what we did in last year was to engage with the FDA in -- on a couple of instances, but the most recent one was an application for, again, the lingo, a 513(g) assessment. And this is a preliminary meeting with the FDA to see if they believe there's a predicate device, so we could do 510(k). And they basically said, no, we don't believe there is. You will be a novel product in that respect. But they also indicated that we would be in a risk classification, which would allow us to do a de novo. It becomes a little bit technical. In short, it confirmed what we already expected, but the issue with the de novo is that it typically requires quite a bit of clinical data, and we were also asked to provide additional clinical data from the U.S. and that is why it has taken quite a bit of time also to get this file together. And we will definitely notify the market when we file the application touch wood. And we expect, as I said, to do this during the first half of this year.

That was actually all the questions. So that finalizes the Q&A. But before we end the webcast, I will just hand over the word for you for your final remarks.

Yes. Thank you very much, Anders, for facilitating this. I know that as one of the questions also indicated that we would like to see more speed and nobody, I believe, would like to see this more than Josephine and I. We are doing everything that we can. And fortunately, we are seeing some lights of spring, I would say, but we still have a lot of tasks to do and we pointed to some of them. Obviously, there are a lot of other things. I mean, we also do the IVDR, as we mentioned and so on for our existing products. So we have a lot of things to do. We can execute with a relatively small organization and work very strongly with our Polish development partner and so on. So I think we have the right setup for the organization right now, and we look very much forward to delivering on the promises that we've made on some of the projects that I mentioned. Thank you very much.