ViroGates A/S (CPH:VIRO)
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Earnings Call: Q3 2024

Nov 8, 2024

Operator

Hello, and welcome to this Q3 presentation and Q&A with ViroGates. With us today, we have the CEO, Jakob Knudsen, and CFO, Josephine Baum Jørgensen. There have already been pre-submitted questions on Stokk.io, and the Q&A is still open so that you can submit questions live as well. To start with, there will be a presentation from the company, and I will now hand over the mic to Jakob and Josephine to start the presentation. Jakob and Josephine, your lines are now open.

Jakob Knudsen
CEO, ViroGates

Thank you very much, Anders. On behalf of Josephine and myself, we are happy to present our interim report for Q1 to Q3 2024, and I'm going to do the general introduction of the business as such, and then Josephine will take over at the end to present some of our products and also the numbers, so without further ado, we will jump into it. We are in a bit of a transitioning mode here at ViroGates. We have historically, as some of you will know, been targeting the hospitals to a large extent. That changed roughly about a year ago, but with increasing force, I would say, are we now implementing our more health-oriented longevity strategy, so that also means that we have revamped the presentation slightly and are focusing a little bit more on the longevity side of things today.

In short, we were founded back in 2001. We were roughly 12 employees, and we IPO'd in 2018. We generally help people live better lives nowadays, and we do so by assessing levels of inflammation. Most of you will probably have come across the term inflammation, which is sometimes also called an infection disease within the body, but it can be caused by a lot of other things. Inflammation is an underlying driver of a lot of diseases, and if we can prevent this and decrease the level of inflammation, we stand a much better chance of avoiding lifestyle-related diseases. We know that we have a global healthcare system that is increasingly under pressure. That drives also that we, as individuals, take more responsibility for our own lives earlier.

We see it by way of an increasing amount of private healthcare insurances, even in publicly insured geographies like Denmark and many other European countries. So a lot of people, but we also, to an increasing extent, we take a bigger interest in our own health and try to, at least most of us, try to live as healthy as we can to have as many healthy lives as we possibly can. suPAR is a molecule that is found. It's a protein in the bloodstream. It basically reflects the level of inflammation, often referred to as chronic inflammation, but it actually also captures an element of the more acute inflammation level. It's generally the immune system's activation level, you could say, that is at stake here. So if we live with an increased stress reaction in our bloodstream, we increase the risks of cardiac attacks.

We increase the risk of cancers, type 2 diabetes, and so on. So chronic inflammation is something that we want to avoid because it's basically a predictor of our risk of these long-term diseases. This picture, many of you might have seen before. We use it as a general entry point to understand suPAR. So generally, we have many more people in the 0-4 ng/mL of suPAR in the bloodstream than we have of the large amounts. But we do see the people with the high amounts in the acute care setting, in sepsis patients. We saw it under COVID and so on and so forth. So generally, we want to avoid getting to the higher levels because the risk, as depicted here, of survival is decreased tremendously if you have higher amounts of suPAR.

Our first use case that we are promoting is basically how we use suPARnostic in general health, and that is going to be the main topic of the presentation. Then we quickly skip through the hospital use cases. suPAR, as said, is present in everybody's bloodstream and to a varying degree. Generally, most people below the age of about 60 will typically have a suPAR that is below 4 ng/mL . Otherwise, there might be something that is puzzling the suPAR levels, chronic inflammation occurring. What can be done about it? It's generally the typical interventions that we know are effective: stop smoking, activate yourself more, and live more healthy in terms of diet. That is generally the interventions that are being undertaken.

But to an increasing level, we are also seeing drugs that are used to lower chronic inflammation, supplements that can be used, and so on. There's definitely a trend to investigate this more, and this can also be assessed by suPAR. So suPAR is well correlated with both other biomarkers, you could say. So it's generally a depictor of the biological age. So you could say that if an individual has a chronological age of 50 but has a low suPAR, that individual might be determined as having a lower biological age, and basically aging slower than the peers in that group. So that is what is seen on the left-hand side here using a compilation of biomarkers and suPAR. There's also a correlation to facial age in this study. The facial age was determined and correlated with the suPAR.

An assessment panel was looking at the faces of individuals and asked to judge their age, and that correlated, as you can see, with suPAR. To a certain extent, the suPAR can also be seen as with the aging of the facial age. But it just goes to show that suPAR is well correlated with other parameters, including also brain age. As said, some of the typical interventions that are pointed to are diet, smoking, moderate alcohol consumption, lower stress, increasing amounts of exercise, social activity. We have a lot of data underpinning this. It's not just something that we sort of throw out, say, do more of this, that, and the other, but suPAR has actually been well correlated with these types of interventions. That is one of the important things that suPAR can also be measured over time.

So as to say, does this particular intervention have an effect? I.e., smoking cessation is a good example. We've seen smokers that stop smoking. After about a month, their suPAR levels have generally dropped by approximately 1 ng/mL . So as to say, they now have a better life and lower chronic inflammation. The next graph is basically showing suPAR in quartiles. So the lower suPAR quartile can have an effect on lowering your biological age. And as I explained before, compared to if you're in the high quartile, where there might be an increased biological age. So if the individual is approximately 70 with a high suPAR, then the biological age might be higher, and vice versa if the suPAR is less than the peer group. So in our transitioning phase, we are basically working with a lot more other marketing tools that we've been used to.

We need to create more pull effect for suPAR, especially in the initial phase from health clinics, making them aware to present this to their customers. We also typically need a lab in the equation because some of these health clinics send their samples off to labs, and we need to make for that bundle to go hand- in- hand so that the demand from the health clinics is there at the same time that the labs are able to service. So that's some of the marketing work that we're undertaking to make both aware and to push at both points in due time. As we recently disclosed in October, we have now entered into a longevity distribution agreement in the U.S. with a U.S. partner, and some have also asked about that partner. So I think we will actually revert to that when we have the more specific questions.

But it's important to understand that this longevity collaboration is not conflicting with the works that we're doing with Sobi, that I will get back to in just a few slides, because this is basically aiming at setting up our products as what are called lab-developed tests in the U.S., where the individual product is qualified by that specific laboratory and can then be used for customers such as health clinics or hospitals in the U.S. We also, at the same time, did a directed issue. We raised the share capital by ways of injection of capital from the same investor community. The use case in acute care, I'm going to flick through quickly because some of you may have heard it, but it's generally still such that some of our hospital customers use our product in the emergency department for an early discharge decision.

They use it by way of saying patients who have suPAR lower than 4, they can more quickly be discharged, and if they have a higher suPAR, they need further attention. So it's basically an assurance of the other triage scores, risk assessment scores that are deployed in the emergency departments. And we can show by ways of a study that we've done that we can actually distribute the yellow patients that you see in the middle into buckets where we actually have more green patients on the lower side of the chart, and also a slightly higher proportion of the red ones. But those are also the ones that we do want to give attention. We don't want to send patients home sick for them to either die or maybe readmit. So basically, suPAR can be used to determine better the risk status of the patients.

Our guiding treatment is, as you know, also occurring, and we have some hospitals, a few, that are using it now for guiding sepsis. Sepsis is this overreaction by the immune system and is typically seen with very high levels of suPAR. We ran a study in Greece where we basically looked at what is known as qSOFA, the quick SOFA score, which is a risk triage that is deployed for suspected sepsis patients, and if they had a qSOFA of one, we looked at the ones that had low suPAR and higher suPAR, and the ones with high suPAR, they were expedited to antibiotic treatment, and we saw a marked better outcome in terms of the subsequent outcome of those patients with the ones that had the expedited treatment, so basically, that's more along the lines of a traditional proposition to hospitals.

Obviously, we don't want to throw out the baby with the bathwater. So even though that we are focusing a lot more on the longevity side of things, I would say probably 80%-90% of our time right now, we still have customers in the hospital segment. So we are continuing to serve them. Our collaboration with Sobi, we have had in the first three quarters, we had a meeting with the FDA collectively with Sobi. And it is a longer process to qualify our TurbiLatex product, which this is, as opposed to our ELISA product. Josephine will get a little bit back to those products. We're working with the TurbiLatex product with Sobi because it's more hospital-oriented. It's very COVID-oriented, and this is to get a full FDA approval for that particular product.

We are at the moment looking at sampling some samples that we need for rerunning some analytical tests in the laboratory to satisfy the requirements with the FDA. And we expect to have a continuous dialogue with the FDA and will update accordingly when we have news from the FDA procedure. But it's too early, unfortunately, to say exactly when we will be submitting for what is known as a 510(k) submission clearance in the U.S. So we had some payments for some of our work that came in during the quarter, as can also be seen in the cash flow. And I guess this takes it to you, Josephine.

Josephine Baum Jørgensen
CFO, ViroGates

Yes. Thank you, Jakob. Yes, I will start speaking a little bit about our products and the markets that we're in. And as I think most of you probably have heard before, we have this broad product suite centering around suPARnostic that caters both to the high-volume hospital settings or central laboratory settings and to the healthcare clinics. So the first product that we launched was the ELISA Plate. This is primarily for research use since you need to have many blood samples to use this product efficiently since it can test many blood samples in the wells at one time. I would say, however, that we've witnessed that this is also a product that's interesting to central labs that serve smaller healthcare clinics. As they get blood samples from several clinics, they can also use this ELISA Plate effectively. The next product that we launched was the Quick Triage.

That's the near-patient use lateral flow test, meaning that it's this smaller device, and you can do the suPAR test in close proximity to the patient. You need to still do intravenous blood, though. The second, or sorry, third product that we launched was the Turbidometric product called TurbiLatex. It's this automated clinical use that caters primarily to the bigger platforms on hospitals. And we validated this on Siemens and Roche, Beckman Coulter, and Abbott platforms. And then the latest addition to our product portfolio is the POC+. We're working together now with our provider, Genspeed, to fine-tune this product. But it's the same characteristics as with the Quick Triage. It's a near-patient point-of-care test. The difference is that instead of using intravenous blood, you can do the suPAR measurement on fingerprint blood. And we have a commercial presence through both direct sales agents and established distributor networks.

We have direct sales agents in Denmark, France, Spain, and Benelux. And then we have indirect sales through a network of distributors covering largely the rest of Europe and other parts of the world. And then we also serve from our headquarters here research-use-only customers, for example, in North America and Asia. And this is our management team and our board that together has a long-standing experience within life science, healthcare, and diagnostics. And then to what today is all about, our quarterly report. As I probably think most of you have read, revenue came in at DKK 3.396 million. This represents a decrease of 29% compared to the same period last year. And the lower revenue for this period primarily stems from less activity of a few of our large research customers that sort of largely dominated this period last year, especially in the 3rd quarter of 2023.

Then also when revenue from for some years have fallen short, we've also had to face the fact that some of the products that we sourced for our expectations of our higher performance are starting to expire. And this is something that's visible on our income statement as an increased cost of goods, although we have sold fewer of our products. We are, of course, continuously discussing how to use our stock and put it to use most effectively and are mindful in sourcing these new productions. But if you look further down, the lesser effect of revenue on the loss for the period stems from also the positive contribution of other income that Jakob spoke to, the contributions that we're getting from our Sobi collaboration on making suPARnostic available in the U.S. on our TurbiLatex product.

Our operating loss for the period increased by 6%, and our cash equivalent amounted to DKK 7.431 million . Looking at revenue by product, this year or for this period compared to last year in the same period, the product mix has remained relatively stable, as you can see. It is visible that ELISA is on a route to attract more of the space relative to the other products. What's worth noting, and I've mentioned this a little before, is that while we would traditionally view ELISA only as a research product, it's now also the product type that these central laboratories that are servicing smaller healthcare clinics in the longevity segments are using. So ELISA is no longer only a research sale interest marker. It's also what is used by the central lab servicing longevity segment.

Looking at revenue by geographic area in Q3, we witnessed this continuing shift back from North America to Europe more increasingly. This is, as I mentioned before, mainly due to some of these larger research accounts in North America placing not less but smaller orders in the period this year than they did last year, but also the fact that we're shifting in new accounts in longevity in Europe through these central laboratories. This is the view of recurring customers by segment. As you might have heard before, we are accounting recurring customers as customers that within the past 12 months have placed at least two purchasing orders with a minimum value of EUR 10,000. What you can see is that in absolute numbers compared to the same period last year, nothing has changed.

If you look at the intertwining periods, you would see that it's been going a little up and a little down, but the number of recurring customers has been relatively stable. But beneath these numbers, there is a bit of a different composition, you might say, since some of the clinical routine customers that are in these nine customers, they are no longer the traditional hospital or acute care customers that we were used to. They are now these longevity central laboratories. And I think that was it for us, and we're ready to gladly answer your questions.

Operator

Perfect. Thank you for the presentation, Jakob and Josephine. Let's jump directly into the first question here. So the first question is, can you put some more words around the new suPAR Health LLC agreement and what kind of volumes there can be expected from this?

Jakob Knudsen
CEO, ViroGates

Yes. As some have pointed out, I think I saw a note on Shareville that it's not a huge company as is. It's basically an entity that has been created by ways of a collaboration between one of our Danish customers, Aetas, the owner of that entity, and a financial investor that has also an interest and knowledge into the private hospital care, the longevity market in the U.S. So they will start operations. And currently, it's in the making. They will do both warehousing and distribution and so on. But we are transitioning into that, and we are starting to help them now by ways of promoting it to some of the larger hospital chains/laboratories that they have access to. So our CSO was just on a visit in the U.S. with one of the parties from suPAR Health promoting this to the labs.

It's something that is gradually started. And therefore, the entity as such is a collaboration that is in a build-up phase. As to the expectations, we haven't disclosed any numbers there, so I can't disclose them either today. What we said was that there has been a binding minimum order placed, and this binding minimum order will go to some of these, as I mentioned. It's kind of a different route to a registered product. It basically entails that each lab needs to undertake a certain validation of the product itself for a lab individual accreditation. And the minimum order will primarily go to that use. And the spread of undertaking that order, we will have to see when we get closer to the implementation in each lab.

Operator

Yeah. And then the next question here is a question with multiple questions in one. So maybe let's divide it a bit and take the first here. Who do you see as customers for the new released fingerprint test? suPARnostic POC+, and market potential.

Jakob Knudsen
CEO, ViroGates

Yeah, that's a good question because, as some may recall, we basically developed and released that product quite some time ago. Unfortunately, and the aim of that product was basically the acute care setting. And that is where slightly higher suPAR levels are found. We basically designed the product to be able to capture a wider range of suPAR. We found that the product was not working to the standards that we required. And therefore, we are right now working with Genspeed in reconfiguring the product so that it probably will measure a more narrow space of suPAR.

The ambition there is basically to get it to work in the lower end of the spectrum so that we can use it for the customers that have smaller healthcare clinics where we can place it instead of the Quick Triage that Josephine pointed to because it's a fingerprint product, as said. So it's a much more usable product in that setting. And we would anyway rather to the acute care facilities sell our Turbidometric product if we can do that. So basically, we aim to see if we can get this into the longevity market. And as for market potential, we are actually still doing some strategic work. And it would be nice if we could sort of pull a number for our market potential just out of the hat.

Unfortunately, we have to combine information from various sources, both with respect to the number of tests done in labs and segment that out to what is hospital-wise longevity and so on. And that is not a trivial exercise. So we know that the market potential is huge. Whatever we dig out of, whether we look at lab tests for longevity or longevity itself, are huge numbers, but we'd rather revert on that when we have something that we believe is more attainable as a potential market. Is that fair to say, Josephine?

Josephine Baum Jørgensen
CFO, ViroGates

I think that's fair.

Operator

And then the next part of the question, I don't know if you have already answered it or if you have anything to add here, but the question is, who is behind the new U.S. company suPAR Health? Do they have any knowledge/relations of the health longevity market?

Jakob Knudsen
CEO, ViroGates

Yeah, I think we've covered some of it. I can add to it that one of the investments that this investment vehicle, the Remedy Partners have had, is a company called Signify Health that was sold to CVS, which is one of their really large healthcare providers in the U.S. So basically, they have strategic knowledge of, and Signify Health was an IT company aimed at managing hospitals in the private sector. So they do have connections and insights into the relevant market. So it's one of the points where we exactly need to start because if we can get some of those labs open in the U.S., it's much easier for us to effectively roll out to individual clinics rather than going clinic by clinic because that's a much smaller market and many more customer visits needed.

So we'd like to see if we can get the labs open because they're much more commercially oriented in the U.S. where they actually sell their products to the individual health clinics.

Operator

Yeah, and then the last part of the question, what is the long-term sales potential in the U.S. both for Sobi and suPAR Health?

Jakob Knudsen
CEO, ViroGates

Yeah, again, I think suPAR Health would be the longevity market. Sobi, and I think we've answered that, that we basically need some more groundwork done, and then we'll be happy to share the assumptions like we did with the acute care market where I think we made a fair assessment of what is the targetable market, so I would prefer to revert on that. With respect to Sobi, it seems a little bit odd maybe to the observant that we are aiming for a COVID indication, but the sort of philosophy behind that is that Sobi got what is known as a post-emergency use authorization commitment from the FDA to facilitate the registration of suPARnostic, and that has to follow that indication.

And then we can broaden the indication later, but we need a spearhead into the FDA first, and then it's much easier to broaden the indication when we've done all of the analytical work that we need to redo on our products. So that will likely spread out also to sepsis, but that's going to be on the longer run.

Operator

Yeah. And then we have the final question here. Do you have an estimation of revenue effect in 2025 from the Sobi collaboration?

Josephine Baum Jørgensen
CFO, ViroGates

Yeah, I can answer that. We don't have any estimation for the revenue effect as such since for the current time being, the collaboration with Sobi is something that's not accounted as revenue, but it's accounted as other income, so a contribution to our efforts in the U.S. and in marketing or getting this clearance to market suPARnostic. So whatever contribution it might have this collaboration will have with Sobi, that will be covered in other income. And we do have some positive contribution based on the fact that we are able to effectively source what we do of work with our provider in Sobi. I think, yeah, if you want to complement or add something.

Jakob Knudsen
CEO, ViroGates

No, I think that's a fair statement also how we accrue for the income that we have. Yeah.

Operator

Yeah. Perfect. That was all the questions. So that finalizes the Q&A. Just before we end the webcast, I will hand over the word for you if you have any final remarks to end with.

Jakob Knudsen
CEO, ViroGates

No, I would just like to thank the audience for both posing questions in advance. That's always well appreciated. Also for listening in. We are very eager in this moment to start this sort of new version of ViroGates. We have a lot of things ongoing with respect to new marketing. We have new people in marketing and fresh winds here at ViroGates with respect to the new segment. So it's a very exciting time here, and we look forward to reporting back and hopefully also with more encouraging numbers in the future.

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