ViroGates A/S

CSE:VIRO

Earnings Call Transcript

[Operator]

Good morning, and welcome to this Q3 2025 presentation and Q&A hosted by ViroGates. With us today, we have the CEO and CFO of ViroGates. First, ViroGates 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 mic to ViroGates. So ViroGates, your mic is now open. Please go ahead.

[Jakob Knudsen, executive]

Thank you, Anders. We are happy to present our Q1-3 report that was released last week. And without further ado, let's jump into the presentation. It will today be given by me, Jakob Knudsen, I'm the CEO of the company; and Josephine Baum Jorgensen, who is our CFO. First, a couple of forward-looking statements. And we will then go into a summary.

[Josephine Jorgensen, executive]

Yes. I actually think I have to redirect you, Jakob, because this is not the correct presentation...

[Jakob Knudsen, executive]

No, it's not...

[Josephine Jorgensen, executive]

This is the actual quarterly report that we are supposed to talk about today, but not the presentation that we have prepared. So you might have to give us just a few minutes to find the right one.

[Jakob Knudsen, executive]

There we go, sorry for this mishap. This was the actual report that was loaded. But this is the presentation. So we'll proceed immediately. All right. As a basis, we're a company that was founded back in 2001. We are headquartered here in Denmark. We operate in a kind of a semi-virtual style, in the sense that we have all our products manufactured by third-party manufacturers. But other than that, we control all the IP or the marketing and sales activities and so on from our headquarters here in Denmark.

We IPO-ed at the First North here in Copenhagen in 2018. We're currently in 9 employees, and we work within the health care sector, providing in vitro diagnostic tests. We all know that the global health care systems are under increasingly pressure. There is an aging trend, which also is associated with more chronic inflammatory-related diseases such as cardiovascular disease, type 2 diabetes with the obesity and also cancers and so on. And people are increasingly trend seeing that they want to take charge of their own health.

So preventive health care where we generally, as a population, take much more responsibility early in the process rather than just waiting to be sick and to be cured by a health care system. So that is our vision and overall vision. And now we need to progress. Okay. So suPAR is an indicator of chronic inflammation. It has a very high predictive value. So it's a little bit different to the typical diagnostic products where a positive outcome is associated with the presence of a particular disease. We are much more broad in the sense that we basically detect chronic inflammation, which is an underlying condition of many of the lifestyle-related diseases that we encounter nowadays.

The suPAR is a naturally occurring protein in the human bloodstream, and this is what we measure by ways of our antibody-based products. It reflects the immune system's activation, thereby this occurrence of inflammation. And it's a strong indicator, as said. So whenever suPAR is elevated, there's a high risk that this will eventually lead to some sort of inflammatory-related disease.

We have a lot of publications based on our products. There's to date more than 1,100 peer-reviewed papers in leading articles, and this can be seen on the website, pubmed.org, I believe. But that's where all our peer-reviewed papers are published and most of them can be read without a subscription. Some might need a subscription, but there's typically an abstract. This is, as some of you may know, quite an old slide in the sense that it shows how the survival rates of different areas of presence of suPAR in the bloodstream is.

And it generally shows that the lower the suPAR, the better the prediction of survival. And this goes for cardiovascular disease, for type 2 diabetes and the like. So this graph basically illustrates that the higher the level of suPAR, the worse is the prediction for a negative outcome, i.e., in this case, the survival rates, and this is taken from a hospital study. So it's not so related to what it is we are currently aiming to do, but it still nicely reflects this positive predictive value of suPAR.

What we like to talk about today is our current focus. We basically want to facilitate the general health and longevity market with predictive products, and this is what we're currently focusing on almost exclusively. So what we've developed is basically that suPAR can be translated into an alternative to our chronological age. It's basically a biological age where we don't necessarily age chronologically, but some actually age better than others. And therefore, a sort of alternative age can be projected by ways of suPAR. And we do so by referring up against a large cohort of the ordinary population where we've basically measured the presence of suPAR for that particular age rate.

I should say that suPAR is, to a certain extent, related to one's chronological age and also to the gender. So that's why there's a need to actually correlate the chronological age into this algorithm. The suPAR is affected by health factors. So it's reversible, which is one of the strong aspects of it. You can actually change the underlying suPAR by leading a healthier lifestyle, and we like to guide our clients on that path.

It's very associated with this whole trend of preventative approach that people want to an increasing event to take responsibility for their own health and basically try to determine how can I be the best possible version of myself. And also this shift in health care, where we increasingly rely on private health care, even here in Denmark, where it's mostly a public sector disease system, we have these health care insurances, and we also see people actually paying out-of-their pocket for health care visits. So that's the global trend that we are playing into.

This next slide is a depiction of suPAR in what is here categorized as 3 color gradients, the suPAR that is in the healthy range, which is broadly defined as less than 4 nanograms per ml and up to the higher levels. And as I mentioned, suPAR is strongly associated with the disease presence and severity and the progression of that particular disease, all those particular traits that people have, whether it's smoking, inactivity or unhealthy diets because we've actually seen in publications that by reversing some of these trends, for instance, the cessation of smoking, one can actually improve the suPAR levels and hence, reverse that biological age that -- where a more favorable biological age can be achieved. So that is one of the very strong outcomes of getting suPAR measured.

The next slide is a depiction of the power of suPAR, where you can see in this cohort where we looked at several thousands of individuals and looked at the difference in age between the redacted biological age where we saw that even if a particular individual had a certain chronological age, it depends hugely how long -- how good a life, so to speak, that individual is in terms of the biological age, whether it's in the high area of the suPAR levels or the lower area. And there's actually a difference of about 15 years between the high suPARs and the low suPARs. So it actually matters quite a bit where the individual suPAR levels are.

We are playing into a huge overall market of trillions of U.S. dollars, the global wellness market, but we've also tried to narrow it down quite a bit and look at which subsectors of the overall health and wellness markets we are playing into. And we have some metrics here for the size of the chronic inflammation measuring markets and also some of the point of care, et cetera, et cetera. So there are several metrics. Overall, I would say we are playing into a huge market, and it's an increasing market that is very much driven by these underlying trends that I mentioned earlier.

What we've recently -- or actually over the last couple of years, developed is that we like to offer more than merely blood tests. And that's why we like to equip our distributors with more tangible instruments to facilitate the sale of suPAR and we like to see ourselves as kind of a franchise model where we have developed these tools for basically translating chronological age and suPAR levels into a biological age. We also have developed several branding tools that is in the form of recorded interviews and so on that we equip our new partners with so that they can easily get an uptake into the market.

We also try to map customer journeys, et cetera, et cetera. All of these various marketing and go-to-market assets that we can now offer to our new potential partners that will serve this longevity market. And this is what we are doing on a day-to-day basis, rolling this out to new partners because we are primarily a business-to-business by ways of partnering sales, but we actually also handle some of the sales ourselves, and we'll get a little bit back to that. And I'll leave it to Josephine now.

[Josephine Jorgensen, executive]

Yes. Thank you, Jakob, to speak a bit about our products and our team and how we organize. You've also -- if you've been here before, seen this slide before, it's an overview of our products. The first product that was launched by ViroGates in 2009 is the ELISA plate. The ELISA plate was, I would say, once mainly a research product since it has many wells and it makes sense to use it efficiently, testing many blood samples at once. It was primarily a research product.

But now since we've moved into the longevity scene, we witnessed that this is also the product that's really interesting in a longevity and general health perspective to be applied at laboratories that serve multiple smaller longevity clinics doing blood sampling. And the second product that was launched was in 2015, it was the quick triage. In contrast to the ELISA, you might say, it's a near-patient use lateral flow test. So you don't measure many blood samples in one test, you measure one at a time, and you have the ability to do it in close proximity to the client or to the patient.

The third product that was launched was the TurbiLatex, which is our high use, high-volume automated way of measuring suPAR. It is the product that is easily easy to implement at hospitals on these large platforms and machines that hospitals have that are either Abbott or Siemens, Beckman Coulter. And then the final product that's on the table, which you will also hear more about later because Jakob will attend to this, is our POC+, which we launched a few years back, but by putting the first examples of it into the market, we found out that we had to develop it further. So it's currently under further development, but Jakob will speak to that later.

We have a commercial presence that's established through both direct sales and indirect sales. As you see on the map here, we have the darker part is the indirect sales and the green is the direct sales. You'll also see that we have efforts in other parts of the world that's not covered by these categories, direct and indirect, not because it's not direct or indirect, but because it's research use only, whereas in Europe, we are the IVDR marked.

This is our management team and Board consisting of the 4 of us in the management team and 3 nonexecutive Board members with many years of experience within health care, life science, bringing that to ViroGates. And then on to the Q1, Q3 report, which is what we're supposed to talk about today, published last week. When looking at the revenue side, on a positive note, our Q3 revenue rose 49% year-over-year compared to the same quarter last year in '24. However, we had a difficult second quarter performance of this year, meaning that for the whole first 9 months of the year, we're ending up approximately at level compared to last year at DKK 3.5 million instead of DKK 3.4 million last year.

Our operating expenses decreased by 10% and as a result of both higher revenue, lower operating expenses and also the positive contribution from Sobi, our operating loss decreased by 21% to approximately DKK 7.9 million. Our net loss also decreased by 20% and our cash and our cash equivalents ended up at approximately DKK 9 million. And looking to how our revenue distributes across our various products, we see the continued development that ELISA takes up more and more space. We've been witnessing that now for a couple of years.

As mentioned before, we once saw ELISA primarily as a research product, but now it's also the preferred products of this segment that we are choosing to focus on, the longevity and health segment, which is why we, of course, are not unhappy that ELISA takes up more space. We've done several analysis, and we do that on a running basis of how do our customers behave, what's the customer composition, and we can gladly witness, also what supports the increased uptake of ELISA that we have several or several more longevity customers, but also more of our revenue stemming from longevity.

And if we look to revenue by geographic area, there has been a very slight shift in favor of North America as compared to the same period last year. This is also, among others, due to our collaboration with our American distributor, suPAR Health. And if we look to the number of customers we have, we've chosen to implement a measure of recurring customers that is built upon a customer having put at least 2 purchasing orders within the past 12 months with an accumulated value of EUR 10,000 at minimum. So that is how we account for these recurring customers.

And we've seen that increase to 18 recurring customers as compared to at the end of Q3 '24, where we had 16 with an equal divide between clinical routine and research. And just a note on clinical routine, it both covers our acute care segment, so the hospitals, but it also covers our longevity customers, laboratories that are placing orders on a recurring basis.

[Jakob Knudsen, executive]

Yes. And then I will speak a little bit to the recent news and developments. And One of the things that we are working extensively with is this thing that I alluded to this new distributor model. We have a need for new partners, and we've established new partners, for instance, in the U.S. and recently also in Poland. And this is to cater to the longevity and health market, which is substantially different from the traditional acute care that we focused on back in the day.

So we are trying, obviously, to maintain as much as we can in terms of sales and service of our acute market, but all of our marketing and sales efforts are directed to -- actively to the health and longevity market. So that's why we spent quite a lot of time looking at new distributors, new distribution models where we also try and implement this Franchise as a Service, where we basically monetize other aspects of our business than merely the kits that we are selling, but also other valuable assets that we've developed.

One thing that actually happened just after the reporting period was that we got a feedback on our, what is called, a 513(g) request. This is an interaction that we had with our collaboration with Sobi with FDA. We basically asked the FDA for feedback on the likely risk categorization of our products, if we filed and got a feedback that we also anticipated. But anyway, it's important for our future endeavors in that matter that the FDA saw this as a likely so-called de novo application, and we are progressing with our collaboration with Sobi with the aim of filing an application for market clearance with the FDA likely in Q1 of next year.

So this is exciting, but also a lot of work. We're doing this on our TurbiLatex product range, and it's for a clinical claim associated with COVID, which is the indication that was developed. This is going to spearhead our way into the actual FDA system, whereas we still serve longevity by ways of what is known as longevity -- sorry, lab-developed test. So that's a different way of selling into the U.S. and it's probably a little bit -- we have -- we don't have enough time to cover it in detail, but there are several ways of serving the U.S. market, and we will serve the hospital system by one, the FDA track and longevity by this lab-developed test regimen.

It was also mentioned by Josephine that we are doing some additional work on our POC+, which is our fingerprint solution for measuring suPAR. We realized that the product was not strong enough to serve longevity, but it actually worked in the acute care facility, but we decided to pull it back and try to see if we could enhance the sensitivity of the product so that it would better serve our current needs in terms of a product application also for the longevity market.

And we are working very strongly with that. The issue with something like this and the development of a new product is that we're basically faced with having to see the result at the end when we verify and validate the product with actual patients or individuals. So I can't really promise that this all goes well, but we have great expectations based on our most recent lab results with our developing partner, GENSPEED, that are manufacturing the products.

Then also a thing that has been occupying time over the last quarter, I should say, is a public tender offer that was launched in October by one of our existing shareholders for -- with an offer to basically acquire shares at a premium to the closing price of when the tender offer was launched and all of the information regarding this is available at our landing page at virogates.com. So please consult that for any information on that. The Board has also publicly announced that it will explore options to raise more capital. And this we are also dedicating quite a bit of work to, but I can't really speak to the exact aspects of that work yet, but it has been announced by our Board that it's something that we are actively looking towards.

And this concludes the presentation from Josephine and myself, and apologies for the mishap of the file initially and also for the fact that my camera is not very good, but I hope it works.

[Operator]

Thank you, Jakob and Josephine. Let's jump into the questions. So the first question is, could you elaborate on the expected milestones for FDA clearance and EMA clearance under the expanded Sobi partnership? And additionally, what is the anticipated financial or strategic impact in 2026 and beyond once the product receives approval?

[Jakob Knudsen, executive]

Yes, I can speak to that. It's a broad question because there's elements of the FDA and also EMA covered. But since we directly spoke a little bit about the FDA, our ambition is basically now to compile a file for the FDA clearance, and we are actively working with Sobi on that. We work very closely with a regulatory expert at Sobi that are helping us in compiling this de novo application, and this comprises basically 2 aspects. One is the analytical validation where we're doing additional work in our lab with our lab partner, Nutopi in Poland. And then we are compiling results and putting that into records -- into our system.

We're also running a revalidation of a patient cohort in the U.S. with several involved partner, both academics and a commercial lab, and that is also ongoing, and we will put that into the file as well. And then when we've compiled all that, we should be ready for making that de novo application with the FDA. And then it has a certain processing time with the FDA, and we'll see the outcome of that.

We are hopeful that this will go through. But of course, there are always issues in relation to a market clearance with the FDA and standards are relatively high. And since I mentioned this COVID claim, I should maybe say that we've basically chosen initially to go with a relatively small and narrow claim, and this is deliberate in the sense that this is the best way of working with the FDA of getting something that is really cleared at the highest level with a double-blind randomized controlled study that we have as a basis for this.

And then this file can then serve for a broadening of the clinical claims later on. So we're looking forward to continue our collaboration with Sobi on that. On that note, we are also doing additional work for EMA, which is the drug authorization body in Europe, the European Medicines Agency, where Sobi has made a commitment that suPARnostic will be made available for measuring in order to guide the dosing and the application of Sobi's drug Kineret, based on anakinra, the active substance. And therefore, there's also some work that we are doing there, both in our own interest, so to speak, to be ready for what is known as the IVDR authorization. And Sobi is also helping us on that aspect.

So we have quite a bit of close collaboration with Sobi. And it's unfortunately, at this stage, very difficult for me to comment on the potential economics of that. But the U.S. is a big market and an FDA clearance is important for the perceived quality of the product with labs. So it is something that we place some hope. Anders? I think you're muted...

[Operator]

Thank you, Jakob. How do you envision the revenue mix evolving over the next 2 to 3 years between acute care, research and longevity segments? And what internal metrics guide your resource allocation between these areas?

[Josephine Jorgensen, executive]

I can take that one, I think. Well, as noted earlier, both by Jakob and myself, currently, we have kind of maintained our business position on research and acute care, meaning that the customers that we already have success with, and we see that there is an uptake -- recurring also uptake of our products. Of course, we'll maintain those customers, but the development focus is definitely put into longevity.

So on an overall scale, we definitely see it evolving into longevity and general health, taking up much more space when we look to revenue. And we're monitoring this closely, of course, and what we're, among others, looking at and also what guides our expenses or expenditure on those accounts is where do we get this recurring revenue from? How do accounts grow? Do we see them order increasing amounts of products? What are account sizes in general?

We see that laboratories are much greater sizes than clinics, which, of course, also guides our both marketing and sales efforts towards the laboratories. But also since longevity is, I wouldn't say new, but the newest area for ViroGates, we also have qualitative metrics, you might say, because we have to figure out and become wiser at how is our product used with the various customers, what do they need and what you talked about branding, tools, what marketing materials do they need. So it's a mix, of course, between the quantitative and the qualitative. But in overall, we definitely see revenue developing in favor of longevity.

[Operator]

And how does ViroGates position suPARnostic relative to the biological clock competitors? What differentiates suPARnostic as a biomarker for chronic inflammation and biological aging?

[Jakob Knudsen, executive]

Yes, that's an interesting question because obviously, you will always have something that is competing or complementing your products in the market. And one of the things that is highly discussed and also applied, especially in the U.S. market, is the measuring of either the DNA composition, the genomic composition we have or the so-called epigenetic clocks, how active different parts of our genome is in terms of expression different proteins.

And this is something that is actively monitored by certain individuals, in marketing terms call them typically the early adopters of this trend. And one of the things is that in order to have a good quality of some of these more established biological clocks, the DNA, RNA-related products is that it's quite expensive. They are probably 10- to 25-fold more expensive than the suPARnostic, which is what we believe then is a very good starting point. They also differ quite a bit, I would say, according to how they are developed, how -- what types -- where they are measuring on the genome and so on.

So I would say that in our belief, suPARnostic is -- has some unique properties in being this very good overall assessment of the chronic inflammation, which basically drives a very large portion of our lifestyle-related diseases. And therefore, especially if the level is low, there's a very good assurance that you're on the right path, so to speak. And you can also measure suPARnostic consecutively and it will change, whereas a DNA profile, for instance, is a DNA profile. You can change that methylation profile by actively undertaking health interventions.

But it's actually very well documented with our suPARnostic that any changes can be accurately measured. And therefore, it is actually a very competitive tool in that respect. And it also measures something else at a very reasonable cost. So we believe that we are well positioned for this market.

[Operator]

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

[Jakob Knudsen, executive]

Yes. Thank you, Anders. And we are very happy to present our Q1-3 today, not only by ways of the numbers, but also some of the recent developments. I think as Josephine also alluded to, it's quite important that we actually see some positive outcomes of our change in targeting the market. We actually see the first developments now of the underlying trend of obtaining more sales in the longevity market, and we actually see the trends of the higher value of labs.

So it actually guides how we best spend our marketing resources going forward. So it is -- definitely it's a long way, but we are on the right path. So that's very positive to note. So I will thank you all for the attendance by those words. Thanks.