ViroGates A/S (VIRO) Earnings Call Transcript & Summary

Welcome to this H1 2026 presentation hosted by ViroGates. With us today, we have the CEO and the CFO. 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 over the word to ViroGates. So please go ahead.

Thank you very much, Anders. Josephine and I are happy to take this opportunity to walk you through our half year report for the first half of 2026. We've had some encouraging news, and we are happy to give you a little bit more insight into what it is we've been doing over the first six months of 2026. We have a few newcomers, and that means we will also cover some of the basics, but we'll try to take you through in about half an hour, and then we also will allow for some questions. First, a forward-looking statement that is not particularly interesting, but we have to say that it's a report that is prevailing and not what is presented here in case there are any discrepancies. So in terms of our corporate setup, ViroGates is a company that was founded back in 2001. It is headquartered here in Denmark in Birkerod. We IPO-ed on the Copenhagen NASDAQ First North Growth Market in 2018, and we are currently 9 employees here in Birkerod. We operate by a semi-virtual model in the sense that we source our products from externally, and we also deploy a lot of our development externally. And then we manage our IP, our marketing, our sales, our governance and so on and so forth here from Birkerod. But the issue we address here at ViroGates is one of the global crisis facing our health care system. And it's basically this global issue that we see an increase in age on a global scale, meaning that we get more of these age-related diseases, chronic inflammation driven typically, we see a larger share of -- in a demographic sense, larger share of the population being elderly and less able to take care of the individuals being affected by disease, and we also see a pressure on the payment system. So that is -- those are some of the things that we are addressing. And we do so by providing a product that can help guide proactively the lifestyle of individuals so that we hopefully can lead much better lives for potentially also a longer time, but certainly enjoy life while we are here. And we have mission and vision statements, those also covered in the report. So let's skip that for now. Our products and our offerings are generally rooted in solid science. We have more than 1,100 publications that have been driven internationally by research communities, predominantly. Some of it we've funded ourselves and driven ourselves, but the majority is actually done by research groups that have a growing interest in the ability of suPAR to predict outcomes and diseases. And one of the illustration is shown here on the right-hand side, where a study shows the ability of suPAR to predict survival in a cohort. So this was one of the early publications that basically showed that the higher suPAR level, the higher the risk of mortality. And that goes for all cancer developments, type 2 diabetes, cardiovascular disease and all of these diseases that has an inflammatory component, and that actually goes for quite a few of the diseases that we know of. So we've been published in some of the really high accredited journals like Nature Medicine and the New England Journal of Medicine and so on and so forth. suPAR is a risk status marker as we label it. It reflects the chronic inflammation of an individual. In chronic inflammation, we've seen this is a buzzword, if you like, but we've seen that chronic inflammation drives a host of other pathologies, a host of other diseases, all these lifestyle-related diseases such as type 2 diabetes, cardiovascular disease and cancers to name a few. And the beauty of suPAR is that it's an actionable parameter. It's basically something that we can affect by changing our lifestyle and/or by treating an individual better for that underlying pathology. So it goes both as a lifestyle indicator that basically can track whether you are on the right path to leading a more healthy life or you need some sort of intervention, whether that be in lifestyle or in the medications that are taken. And we basically measure the level of suPAR, which I typically label as the sum of the all evil because the higher the suPAR, the more chronic inflammation we have ongoing in the body. And then we need to sort out where does that stem from and how do we reverse that inflammation. We address large markets. We've sort of -- I don't think we should dwell too much into it, but there are a lot of accredited consultancies that have developed reports over the global wellness market, the clinical lab services and inflammation markets, as you can see, all huge U.S. dollars numbers. And we obviously also see it, I'm sure that you, as I do, get bombarded with longevity and health management product offerings and suggestions. And it is a booming trend that with increasing wealth in the society, we want to take more active care of ourselves and lead better lives and that leads to the growth in these market segments that we address. And obviously, we believe that we play a role on the far right in terms of inflammation markers and also some of these DNA markers that you see that we complement nicely. So, Josephine.

Yes. Thank you. I'll start on the product side. As Jakob mentioned, many of you might have heard it before, but we also have some new people on the webinar, so we'll go through them. Our product line called suPARnostic encompasses several products. The first that was launched was the ELISA, that's the one to the far left. It was launched in 2009. It's this larger plate that you use typically in research, but also in longevity labs or laboratory servicing several clinics. It has many wells in it. So it's efficiently used when you have multiple blood tests or blood analysis to do at once. Then followed the QT or the Quick Triage in 2015. They all measure the same. It still measure suPAR, but instead of the ELISA plate, it's a near-patient lateral flow test. So it's a product that's able to be in a situation or a lab that's closer to the patient. Then in 2018, we launched TurbiLatex. This is our automated clinical use product. It's validated on several of the larger platforms that you have in hospitals or larger universities. It's validated on Roche and Siemens, Abbott and Beckman Coulter and made for this high-volume or high-throughput use and suPAR measurement. Lastly, we have the POC+. This is our fingerprint point-of-care product. It's like the QT in the way that it's a near-patient test. But instead of measuring suPAR in plasma as the QT does, it measures suPAR in fingerprint blood. However, the POC+ currently not up for commercial sale yet. It's being validated to fit this new longevity sphere or longevity field that we're targeting with our revised strategy. We have commercial presence covering most of the world, I would say, both through direct sales representatives placed here at our headquarter, but also through established distributors in a network of approximately 15 to 20 distributors that we have. In Europe, we sell our products under CE-IVD. They are accredited under CE-IVD, going IVDR, and this is something Jakob will touch upon later. In the U.S. and in the rest of the world, we sell through Research Use Only both directly here from our headquarters, but also via our channel partners. And this is our management and Board. As you see to the left is our management team, and I think Jakob will also touch upon changes that we recently announced in our commercial organization later. And to the right, you see our Executive Board -- nonexecutive Board members. Yes. And then on to what today is really about the half year report. We had an increase in revenue of 173%, which is a pretty marked increase from the same period last year. We ended up at DKK 5.1 million, whereas the first half of '25 was DKK 1.9 million. Again, which is also both announced in the company announcements for the report and in the report itself, the increase in revenue is largely due to our American or U.S. partner taking delivery of a minimum order that was agreed under the distribution agreement back in '24. So what they've done now essentially is that they've taken home these large orders and large amounts of products and what awaits and ongoing is the distribution of these products to end-user testing in the U.S., which we're, of course, looking very much forward to. Our operating loss improved by 33%, ending at DKK 3.9 million. And our cash balance ended at DKK 17.6 million compared to DKK 11.9 million last year. If we dive a little bit deeper into our financial highlights, we have here the revenue by product, showing the development from the first half of '25 to the first half of '26. As you see, which I think is no surprise, ELISA has gained even more space. It's a development that has been for quite some years now and especially with our U.S. partner who has distribution on ELISA and has taken on these large orders, that's, of course, reflected in the performance of the first half year. Though in absolute terms, in fact, TurbiLatex has also increased, but it's definitely ELISA that takes the prize of being the majority of our revenue. The same picture, I would say, goes if you look for revenue by geographic area. You see to the right that for the first half of '26, North America and more specifically the U.S. covered by this category has taken up space compared to the first half of '25. And this is our recurring customers by segment. As you see in the first half or by the end of the first half of '25, we reported 19 recurring customers. And after this first half of '26, we report 20 recurring customers. So that's a pretty flat development. And recurring customers is, for those of you that haven't heard this before, a measure that we introduced some years ago, where you -- where a recurring customer is a customer that has placed at least two orders with ViroGates with an accumulated value of EUR 10,000 within the past 12 months. Yes. And over to you, Jakob.

Yes. So I think on to the more exciting and more sort of forward-looking to some extent. We have been on a trajectory for a period of time actually trying to migrate from a traditional sales-led model into a more business development-oriented model. And Thomas Krarup, that Josephine mentioned has been leading some of these efforts. Thomas will be leaving us shortly. He's given notice that he wanted to leave and we've taken on a new VP of Business Development, but more of that later. The Business Development model is basically trying to scale the sales channel so that we can reach more end customers by handling one partner. Up until now and also partly as a reminiscence from our previous acute care sales, we were, to a large extent, trying to attract the attention of individual clinics, to some degree, also labs. We wanted to get into the labs because they cover a broader span with more clinics. But we would rather see that taking even one more step into a more channel-oriented sales model where we use sales channels that can potentially sell into these larger labs at one point, if you like. And we're defining that transition with Alex. Obviously, we've laid the foundational steps, and we've also seen some examples to them already that I'll get back to here. As I mentioned, Alexandre Delatour or Alex in short, has joined us as VP of Business Development as of 1st of August, and we are very happy to have Alex. Alex doesn't come from the diagnostics industry that many of us have had many years with, but actually comes to us with a fresh pair of eyes, I would say, to this channel strategy. He has a background in more web-based businesses. He has recently been with a supplements company that also operated on a sales channel model that we would like to, to some extent, replicate here. So we look very much forward to working with Alex here taking us even more into the future. One of the examples that I would mention as an example of this channel strategy is the partnership that we agreed back in 2024 with suPARbio in the U.S. suPARbio was set up as a new organization that wanted to introduce suPARnostic for longevity and health management into the U.S., and they focus very much on this amplification of the sales by ways of targeting sales channels. The U.S. has a much more broadly developed, much more refined, I would say, in terms of at least longevity channel strategy where providers that will be either insurance companies or that could potentially be led by the employers or individuals signing up. They have access to various services, and we would like to get into those channels because it's a much more efficient way of driving sales than what we've seen with selling into one clinic at a time because it's simply too time-demanding to get to sizable revenues. So on the right-hand side, you see simplification of that. If you look at it right now, we have a couple of those channel partners in place, both the U.S. and also in Poland recently. But back in the day, we worked more like bottom-up, if you like. And that's also necessary to affect the clinics because there needs to be a certain level of pull before we can introduce the push. So it is still a push-pull effect, but we are ready now to take this into the next step and introduce this channel strategy. So focus points for the second half of 2026 that we look very much forward to continuing our work with is supporting this U.S. rollout. U.S. is by far the biggest single longevity market, health management market on the planet. It is not homogeneous, but there are some structures in place with respect to blood sampling and with respect to supporting efforts like this in hospitals. Well, in the health care system that has been set up from a private initiative initially as opposed to the more state-owned systems here in Europe. So we are a step behind in terms of this. And therefore, we also do whatever we can to support that U.S. rollout, both in terms of product knowledge, software solutions and marketing contributions by the way. Then what was also mentioned, we filed a De Novo application with FDA. This is a reminiscence of some of our corona work, but it's still important also driving this into the future, because we had the ability to work with Swedish pharmaceutical company, Sobi, to develop an application for the U.S. FDA to review. And the U.S. is also quite favorable and the biggest diagnostics market on the hospital side. So we would definitely pursue this to try and get an FDA clearance for our suPARnostic TurbiLatex product for hospital application, and this would be a huge blue stamping of our product suite if FDA nodded to this. We have had some questions from them, and we are addressing them as we go along, and we have recent communications also with the FDA, and we also have an upcoming consultation with them. So this is also something that is time-consuming, but also very exciting for the company if we can get an FDA clearance. Then we are progressing our POC+ that Josephine mentioned. We had to do further development on the product in order for this to be precise enough in the lower range. And this is what we've seen some encouraging data from but we're not quite there yet, and that product also from a regulatory point needs to go through a more excessive scrutiny here in Europe before we can launch it. So it will be some time, but there is work that we are doing with our partner, GENSPEED Biotech in Austria. And then it's basically progressing with our new commercial model that we are still developing also with the contribution recently of Alex. So this is something that we are refining. But as mentioned, we have been sort of paving some of the way as we went along with the initial partnerships, but we look very much forward to doing more of that revamping over the next half year. And this completes our presentation. So Anders, I think we are ready for any questions that might have been posed.

Perfect. Let's jump into the first question. The 173% revenue jump was driven by suPARbio taking delivery of its minimum binding order, which now sits as stock at the partner rather than end-user testing. What visibility do you have on when that inventory converts into actual testing and reorders? And should we expect a softer H2 top line before pull-through begins?

Yes.

Yes. I can at least start by answering that. To the first part of the question, the analysis is correct. A large part of the increase in revenues stem from a big order from suPARbio in the U.S. As to transparency in us following along, of course, we are checking in regularly with our partners in suPARbio. We're supporting them, as Jakob also mentioned, operationally regarding the products, the marketing and so forth. But we're also supporting them through a software where we can also see the use, the end tests you might see, say, in numbers. So in fact, we are able to quite well follow along on how this is progressing in the U.S. And of course, this is the really interesting part for the next period and especially also next half year to see them convert this stock into actual end user tests. And I think that also leads well on to the next part of the question regarding the -- what we expect of the H2. I would revert back to us recently revising our guidance on revenue to expecting between DKK 6.5 million to DKK 8 million in revenue for the full year and continued EBIT as previously guided. And the reason why we've chosen to revise our guidance in that way is, of course, to allow for the potential that definitely lies in the U.S. rollout, but of course, also the risk and timing, but also us changing our commercial organization here. So it's to allow for kind of the possibility of a higher performance, but probably not at the level of what we've seen in H1.

And the next question, you ended the period with DKK 17.6 million in cash and say you expect the FDA to request additional data, which you describe as a significant commitment for the year ahead. Roughly, what does that data package cost?

Yes, that's a good question because we have, as I mentioned, these consultations with the FDA known as Q-Submissions where you basically consult with the FDA to check on the work that you intend to do to substantiate the application. And this is not finalized as we speak. So we can hypothesize, but we don't expect it to affect our cash balance very significantly, I would say. It's -- we do need to run some more data in the laboratory. We know that, and we need to conduct further analysis into a clinical data set that we've also been using from the U.S. and this is owned by a couple of university hospitals in the U.S. So we work with them to generate that data. And obviously, we need to pay for them. Sobi has paid part of that as part of our collaboration with them in our joint development agreement. But we have now delivered what we needed to under the work packages, but I can't put a finite number to it, but we're not talking substantial amounts cash-wise, but we do need to spend quite a bit of time on it.