ViroGates A/S (CPH:VIRO)
Denmark flag Denmark · Delayed Price · Currency is DKK
10.80
+0.50 (4.85%)
May 6, 2026, 2:02 PM CET
← View all transcripts

Earnings Call: Q4 2023

Mar 21, 2024

Operator

Good afternoon, and welcome to this annual report 2023 presentation and Q&A with ViroGates. With us today, we have the CEO and CFO. First, there will be a presentation, and afterwards, a Q&A, where the CEO and CFO will answer questions submitted via Stokk.io. 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. I will now hand over the mic to ViroGates to start the presentation. Your line is now open.

Jakob Knudsen
CEO, ViroGates

Thank you, Anders. We are here and presenting the annual report, which was just released around noon today, so it is fresh out on the street. The way we're gonna do this is so that I will initially do a more general presentation, and then I will get into some of the use cases, some of the initiatives that we are particularly pushing. Some of them have been started already last year, but some of them are also more forward-reaching. But we'll get a little bit back to that. So without further ado, this is the front page of our annual report, and the reason why we chose those graphics is that we have...

We are now operating both in this traditional hospital sector, but we are also moving into the longevity health screenings part of the market, and Josephine is gonna present us with this later. We have the traditional disclaimer, so this may not be new to all of you, but since we need to get on the same page, ViroGates was founded back in 2001. It was a spin-out from a university hospital here in Denmark. We are currently around 12 employees. We have a couple of student assistants coming in to help us and so on. So we are versatile with respect to both gender and age.

We are listed on the Nasdaq First North Growth Market, and we listed back in 2018, so we have some experience with the market there. We are working in the diagnostics med tech area of the overall life science market, and we use our products to determine a particular protein in the bloodstream, the suPAR, and we do that to improve outcomes and people's lives in general. What we're addressing are some of the key trends in the market, in the overall world. I should say, we experience individuals putting pressure on the healthcare systems.

We know that individuals are not necessarily responding well to physicians that are saying, "You just need to do XYZ." We need to take charge of our own health, and we see that increasingly both in the established sector, but also outside. We also know that this places a huge burden on the payers, whether it's the public sector or the more private insurers, that people want to live longer and want to live healthier lives. So we demand increasingly more costly payments in the healthcare sector. Furthermore, we have the healthcare professionals that are challenged. Despite the fact that we may employ more people, there are an increasing demographic pressure on the sector.

So, we need many more, physicians and nurses, healthcare workers, to take care of this, burden, and we need the adequate measures to help, deal with that, pressure from the, from the outside world. suPAR is a naturally occurring protein in the, human bloodstream, so, we all have a certain level of it. But, the more we are subjected to, chronic inflammation, the more suPAR we get in the bloodstream, and it's generally a reaction that the immune system is overburdened. It's occupied with dealing with, inflammation, in the body somewhere. So, suPAR is, in general, a strong indicator of inflammation. It's, as I like to say it also, the sum of all evils. It actually sums up our level of inflammation in the body.

suPAR has been extensively researched, and we have, actually today, 999 papers in peer-reviewed journals. So we are looking at the odometer to when we're gonna transition into the article number 1000. The first use case that I'm gonna present is how we use suPARnostic in acute care. This is one of the, if you like, older use cases that we have. We're still pushing it. It's still something that is really relevant, but it's not a big secret that it has taken us time to get into the established sector. But we do have customers that are using our products in this way.

What we're looking at here are retrospective data, but if you look at the green lines, you can see on top that the survival rates that is shown on the x-axis is much, much better for individuals with lower suPAR. And this is one of the key aspects of our products that we utilize, whether it's in one condition or another. On the contrary, if you look at the red lines, you can see that with the increasing amount of suPAR, the 30 or 90 days mortality survival rates are much less for individuals that are affected by high suPARs.

So this is one of the reasons why we propose that, if, if physicians are using suPAR, in addition to other measures, they, they will be better to triage the patient, i.e., risk stratify them. So in general, what we've learned from, actually more than 30,000 patients in a recent meta-analysis is that low suPAR, i.e., lower than 4 nanograms per milliliter, that supports a discharge, decision by the physicians. It has what is known as a negative predictive value, i.e., the certainty with which you can determine, to the individual, the, risk of 90-day mortality, of more than 90%. On the contrary, you also have the, high suPAR levels. Those are the ones that are above ng/mL , and that's, one of the situations that supports the hospitalization.

Obviously, the physician will need to take into account the individual patient that they're handling, but it's without further knowing the patient, this is definitely a strong suggestion that something needs to be investigated further. This is also data from a retrospective analysis. I'm still very fond of this. It basically shows how the individual patient's places in various groups of triage. So the top bars on each color are the bars showing how suPAR how patients are triaged using the traditional parameters such as the National Early Warning Score in this particular case. Some of those are some of the vital signs that we know the cognitive functions, respiration rates, and so on, of the patients.

And you can see that, for instance, looking at the yellow bars, that there are many more patients in the yellow category than on the lower bar, where we have applied suPAR and re-triaged the patients, i.e., placed them in different categories. So if you look at how the patients split into the green and the red group, we have many more patients in the green group. We actually also have more patients in the red group, but we also want to capture the ones that do belong in the hospital. So this is how we propose to use suPAR in the acute care triage setting. That we have also shown that we can basically save 6% of hospital length of stay, as it is known.

So it basically frees up some of the hospital resources. It also improves the patient outcomes, because basically, if you're, if you're not belonging in the hospital, you don't want to be in the hospital with the risk of hospital-acquired infections and so on. Furthermore, it empowers the clinical staff that may be able to take a discharge decision much earlier than otherwise. So it basically benefits on three different parameters, and that's what, how we've created our value propositions. The next slide is examples of how suPAR can be used in guiding treatment. As I mentioned, it's not a big secret, and it's also reflected in some of the numbers that Josephine will come back to, that it has been a challenge running suPAR in with the traditional suPARnostic Quick Triage message.

So the way that physicians are using biomarkers is much more in this area, and this is some of the use cases that we're gonna promote going further. First of all, we had some data last year, end of last year, in sepsis. This is sort of blood poisoning, the effect of typically an infection that also affects the vital organs. And this septic condition is one of the deadliest risks for patients coming into the hospital, typically elderly comorbid patients that suffer an infection, and the system is not able to cope with that particular infection. The only sort of...

The most important to patients in this setting is that it's identified as early as possible, and intervention is done, typically by ways of treating the infection with antibiotics. We have a tendency of preserving antibiotics to some extent, and this, we obviously know that it's due to the risk that we may not have effective treatments if we are all treated with antibiotics all the time. We have multi-resistant bacteria and so on. So, this, these are some of the issues that are battling with the patients coming into the acute care setting with the suspicion of sepsis.

We ran this study as mentioned, with a Greek hospital, and the sepsis guidelines of today is typically to use what is known as the qSOFA score. It's a quick way of assessing the SOFA score. SOFA is much more extensive, so a scoring system was developed that was quicker and using the qSOFA score, if the outcome is two, there's typically an intervention by ways of using typically antibiotics, fluids, and so on, that the patient is taken care of. Whereas if the qSOFA is one, it's typically an observational case. So that patient may be placed in observation. The patient may also go home, but typically placed in an observational bed. And then if the disease progresses, then something is done.

We know from all experience that this is the worst thing that can happen if the patient actually progresses, and the SUPERIOR study addressed this particular issue. So the study was designed so that an intervention was done with an injection of saline water or an active treatment by way of an antibiotic. And what we saw was the outcome after the SUPERIOR study was that if the patient had a qSOFA of one but had a high suPAR, then the patient actually needed to be treated early on with antibiotics. Whereas if the suPAR score was less than 12, then the patient could actually be placed into the observational bed. So it basically leads to a different way of triaging, way of treating the patients.

And it also reserves the antibiotics for the patients that are in true need of the treatments. So this is a strong proposition that we are pushing at this point in time. Another example is what we did during the COVID pandemic, and which we did a similar kind of study where we used a different drug, but to the ones that came in with respiratory problems and a positive COVID test, we treated them with anakinra, Kineret from Swedish Orphan Biovitrum, the Swedish company. And the outcome of that study was that we also improved the progression of the disease in COVID-19. So it's kind of the same way of improving a treatment algorithm.

There, we used a cutoff of 6 ng/mL , where the patient was either randomized to standard of care, i.e. the typical. It could be other types of treatment, the antibiotics and so on. Whereas the anakinra treatment was then reserved for the patients that had a suPAR of more than 6 ng/mL . So this also changed treatment for a period of time. Obviously, we all know that COVID is not as present in our everyday lives anymore. The reason why we still mention it is twofold. It's a good example of how we can utilize the products in the actual management of patients.

But furthermore, it's also the foundation of what is known as a post-authorization commitment that Swedish Orphan Biovitrum, Sobi, was placed with the U.S. FDA. They were basically asked by the FDA, in return for an emergency use authorization of their product, that they should facilitate that suPAR was made available in the U.S. market. So hence, we made an agreement with Swedish Orphan Biovitrum, where they are subsidizing our efforts in relation to getting a U.S. approval of our product or market clearance of our product. So this is still something that is ongoing. We will report once we know something that is tangible in that process, but so far, we've announced that work is ongoing. We also have some numbers put to that.

It basically caters to the same type of value propositions of improving outcomes, empowering clinical staff, and also affecting the cost of the healthcare system, whether it be the anakinra treatment on the right-hand side or the sepsis case on the left-hand side. So this is definitely something that is somewhat easier to get the approval of the medical staff, and it's something that we are looking forward to pushing further this year. And with that, I'm gonna leave the final use case of using suPAR in general health to Josephine.

Josephine Baum Jørgensen
CFO, ViroGates

Perfect, Jakob. Thank you. Yeah, I have the honor of speaking of one of our newer segments of business, this longevity or general health segment. And as Jakob touched upon previously, suPAR does reflect chronic inflammation, which is also an essential parameter that affects lifestyle-related diseases such as type 2 diabetes, cancer, or cardiovascular diseases. The biggest value proposition also for suPAR within this longevity area or general health is the fact that as opposed to some of the other biomarkers in this area, you are actually able to change your suPAR level by leading a more sustainable or healthier lifestyle. So it gives you some sort of agency that something can be done to make your situation better.

What you see here is some results from a study of the Danish MONICA Cohort that included approximately 3,000 presumably healthy individuals. Or the study set out to figure out whether suPAR levels also in the general population, so not necessarily in a sick population, but in presumably healthy people, does predict mortality and disease development. And what you see from the graph on the right is that there is a big difference from those that are in the lowest suPAR quartile. That means those with the lowest levels of suPAR and then those with the highest levels of suPAR. There is actually a difference of approximately 15 years in increased life expectancy, which is really something that you can touch and feel upon. That's quite a lot.

And to sum up a little bit about this new area for us, what really makes suPAR valuable is this fact that you can figure out, you can get tested, you can figure out that you have a high suPAR level and a, and an exposure to disease development and to early mortality, and you can actually reverse it and do something about it. And what we see to the right here is that we've also had this study where we tested whether certain lifestyle changes could affect your suPAR level. And something that's very concrete is smoking. And I guess it's no surprise to anyone that smoking is not good for your health.

But what we see here is if you follow a population where the light blue line is the part of the population who stopped, who were smokers and quit smoking, their suPAR levels decreased remarkably during those five years. And in this study, we then followed up, and after approximately six years, you saw that this level of suPAR was really indicative and predictive of disease progression and mortality. So it really, a high suPAR level is not a death sentence, but it's a red flag or a yellow flag that you're supposed to, and that you can actually do something about your health to increase your healthy lifespan. Yeah. And then on to a little bit more about our products and business model and team. So we have a broad product suite with four very...

four different products that caters both to our hospital customers that tests in high volumes and many patients, and also to smaller healthcare clinics, which is something that's especially prevalent within the longevity segment. And the first product that we launched was back in 2009. That's the ELISA plate, and that's typically used for research. Then we, after that, launched our Quick Triage, which is near patient use, so you will get results rather quickly in near proximity to the patient. You still need to have a centrifuge, and you still need to be at a lab to be able to conduct this test. And then we introduced our TurbiLatex product, which is our automated clinical use.

So we validated our suPARnostic on various of these platforms, which you also see on the slide. This is the use that's intended for the hospital segment. Then we lately released our POC+, which, as the quick triage, is also a near patient use. Difference with the QT and the POC+ is that the POC+ can measure your suPAR level, not in plasma, but in finger prick blood. So as you might know it from other biomarkers, for example, CRP, that you get a finger prick, and then you're able to measure it. Yeah. And we have a commercial presence through both direct sales representatives and through established distributors.

As you see on this map, our direct sales are in Europe, and then we cover a large, large part of the rest of the world via distributors. And we also have a large amount of research-use-only sales, primarily to North America. And this is the management team and our non-executive board. And together, there's a wide experience within the life science industry and the medtech presence in these two groups. And then on to what we are really supposed to talk about today. It's the annual report for 2023 that we just released earlier today around noon. And in 2023, we did achieve some very important milestones. We launched the POC+, which is the finger-prick product that I just spoke of before.

We did a launch of that in springtime last year. We also expanded the number of platforms that our high-volume product, the TurbiLatex, the metric product, we have TurbiLatex. We expanded that to further platforms. We entered into this agreement with Sobi based on the post-authorization from the EUA regarding their Anakinra treatment. And then we received these really important results of suPAR-guided treatment that are results that caters to our hospital segment or to our hospital customers, but has a very concrete indication and guidance for treatment, and then at the end of the year, we completed a rights emission that strengthened our cash position going into 2024. And as Jakob touched upon previously, our revenue was definitely hit hard in 2023.

We ended up 45% below our revenue in 2022, which largely stems from the fact that we left 2022 with lots of our revenue coming from customers, hospital customers, purchasing for COVID-19 reasons. And due to the fact that COVID-19 is still present to some degree, but that it's more rare that you get admitted to the hospital with COVID-19. That recurring sales that we had to those customers really went down in 2023, which we can see on our revenue numbers. And it's quite clear that the decrease in revenue was also what affected our net loss for the year, which increased accordingly. And then if we dig a little bit deeper into the numbers, we reduced our operating expenses by 22%.

We, we increased our operating loss by 16% to -DKK 12.5 million, from DKK 10.8 million in 2022. Our net loss, as you saw before, increased by 25%, to -DKK 12 million, from DKK 9.6 million in 2022. Our cash and cash equivalents amounted to approximately DKK 16 million going out of the year, which is a result of the rights emission that we had in the end of 2023. In 2023, we also saw the product mix switching in favor of ELISA, as you see in the graph to the left. Over time, of course, also as a result that we have gotten more products in our product suite, the product mix has shifted since 2018.

It's been going since 2020, a little bit back and forth between TurbiLatex and ELISA being the largest product that we sell. And it was TurbiLatex went a little bit back in 2023 as compared to 2022, and ELISA gained territory primarily because we witnessed a large research interest globally for our product. And in 2023, at the time of the half-year report, we also introduced a new measure of our recurring customers. We witnessed that the measure that we had at the time wasn't as highly correlated to our revenue streams as we wanted to.

So in order to better inform the market, we have increased or we have altered our measure of recurring customers to put in a threshold that makes it correlate better with our, with our revenue. And I think that was it for me. Yep. Thank you.

Operator

Perfect. Thank you, both of you, for that presentation. Let's go into the Q&A. The first question here is: To get an overview of your sales strategy and sales focus this year, can you provide the three main initiatives you are doing here in the beginning of 2024 to secure growth this year?

Jakob Knudsen
CEO, ViroGates

Yes, I'd be happy to elaborate on that. As you can see, we've already talked about some of the use cases, and therefore, I would emphasize a few of those. The first one being the one that Josephine presented on the longevity, the health screens. This is something that we are promoting heavily at the moment, and we have already seen that the sort of sales cycle is much shorter in this segment. We actually do already have some customers in that segment at this point in time. So the uptake rates are faster than in the hospital segment.

We don't expect that the sales to skyrocket overnight, but it's one of the segments that we are gonna focus a lot on in 2024. Another one was the one that I presented, the sepsis case. As I also alluded to, the way of using a biomarker to point to a specific intervention, the treatment, is something that is somewhat easier to sell than the general triage message. So, we're gonna utilize that, and we've already seen a couple of customers in Spain that sort of appreciated that message and are on the verge of implementing the product.

So the sepsis story that is fresh off the research market, so to speak, with the SUPERIOR study, is something that we're gonna push heavily as well. The last one that I would point to is, Josephine mentioned that we had a distribution channel also in the U.S. You also heard me talk about the U.S. FDA and the formal process that's on the federal level. But there is actually also an opportunity to sell into what is known as the lab-developed test market in the U.S. Lab-developed tests are tests that are individually accredited by labs in the U.S. So a U.S. larger lab typically has the opportunity to say, "This product is interesting.

It may not be cleared by the FDA, but we do an internal validation of the product, and then we put it to use." And we have a couple of, or actually three customers that are looking into this. So this is something that we see quite a bit of interest in. We still like to pursue the FDA accredited route because of marketing reasons, but it is still something that we expect on the shorter term. So we do expect revenues from that area of the market in 2024.

Operator

Perfect. Then there are a few questions around the sepsis market. The first question is, you explained in the report that you are looking into the sepsis field and focusing here. Can you explain what the strategy is, and when we can expect to see results of you targeting this area?

Jakob Knudsen
CEO, ViroGates

Yes. I think I covered this as well. Yes, as mentioned, sepsis is not a new thing to ViroGates. It's actually... There are some studies out there, quite a few, also dating back in time, where we have looked at how sepsis affected suPAR levels in individuals. What we were lacking was a tangible intervention, as mentioned, something that would be changed due to the fact that suPAR was measured, and that is what we have now. So now we can basically point to a subset of the sepsis patients, the one that are sort of falling in between two chairs, where suPAR needs to be looked at and used actively to see if an expedited dispensation of antibiotics is needed.

So this is sort of the tangible intervention that we've seen in the sepsis market and something that we expect a lot of. As mentioned, we already have customers that are on the verge of implementing this into their clinical routine.

Operator

How big is the sepsis market for ViroGates in your primary markets?

Josephine Baum Jørgensen
CFO, ViroGates

I mean, the exact numbers in our primary markets are, of course, a little bit difficult to estimate, but we've estimated a rather large potential of DKK 1 billion within guiding treatment in Europe and in North America. And I would say Europe being our primary market, I don't have the specific number here, but sepsis is one of the diseases that causes the most deaths annually. And the fact that our biomarker can be very helpful in figuring out who in these subgroups that might be left to observe or wait, can we treat earlier and then reduce the risk of disease progression, that has a really forceful value proposition.

And also, to Jakob's note, this is also a use of our products that reminds a little bit more maybe of the use during COVID-19. The fact that you have a concrete disease, you have a subgroup, and you know how to treat this subgroup according to what they measure on our biomarker. So it is a vast potential, I would say.

Operator

Are you going to need new salespeople in order to sell into these new markets, or can you use your existing salespeople for this?

Jakob Knudsen
CEO, ViroGates

I can address this. It's basically some of the same customers that we are visiting with the acute care triage message. So it's basically a follow-on. It's basically typically the emergency department that are seeing these patients anyway. So, needless to say, with a relatively small organization and distribution sales, we could probably benefit from a larger footprint out there, but it's something that we can initially address ourselves. So at this point in time, we always look to extend our indirect sales channel, the distributions partners. We might exchange some of the ones that are not performing well and so on.

With respect to salespeople on the payroll here, we're not looking to extend that on the short term.

Operator

How specifically does suPAR come into play in the longevity field? When should people be using it, and how often? Is it something they should buy and do themselves or go to a professional for this?

Jakob Knudsen
CEO, ViroGates

Do you want to address that?

Josephine Baum Jørgensen
CFO, ViroGates

Yeah. Yeah, I mean, I do. Well, it's difficult to give you one answer because it's very individual. Do you want to have this knowledge about yourself and your body and what's inside of you, or do you not want to have this knowledge? Some people, a large part of the individuals want to have this information. If you at least look at the development in self-testing and biomarkers in general, and health, and longevity.

... But I mean, the right time would be whenever you're ready to get this knowledge about your level, whether you are in the higher part of the suPAR levels and the lower part of the suPAR levels. What it depends upon is, yeah, do you wish to get this information, and do you wish to use it for something? Because if you want to get measured, you have a wide array of opportunities to get a better suPAR level, and you can, of course, get measured again, half year later or a year later and see if some of the initiatives that you did has brought fruit. But I mean, it's a very individual thing, but it's not something you should do yourself.

You should go, depending on where you're located in the world, to get it tested at a healthcare clinic. Maybe you want to complement if you-

Jakob Knudsen
CEO, ViroGates

No, I agree. But also to the point of intervention, we've looked at biohackers, so to speak, individual groups that have implemented, for instance, breathing techniques, cold water exposure, and so on. And those people have been measured every three months and seen actually, we had a group of, I think 12 people, where they all improved over the three-month period. But it's not something that we would typically measure every week, but because you probably want to get a baseline measurement and then implement potential changes to your lifestyle in the right direction, and then go and do a follow-up in about three months.

So that would probably be a frequency that would be adequate, I would recommend. But other than that, yes, we're not looking into self-testing because it does require suPAR will require a healthcare professional to be able to interpret and guide based on the results.

Operator

Are you looking to partner with anyone within the field of longevity to get a partner that is used to selling a product like this?

Jakob Knudsen
CEO, ViroGates

Yeah. I mean, we will be open to partnering because to the point of the question, yes, this is a vast market and much bigger than we've been used to addressing. So, and completely different to the more traditional healthcare market. Having said that, we have actually made our initial sales into the segment, and we have both people here and in the field that have been targeting some of the clinics. So, we wanted...

I think when you're a small company like ours, it's always good to get some sort of market feedback, market exposure, also, when going to a partner, because even if you're talking big partners like the Walgreens or the CVS's of this world in the US, that are handling lots of people, they may know a lot more about handling individuals in healthcare settings than we do. But we know our product the best, and therefore, it's nice to get the most prevalent issues weeded out before you talk to partners. So right now, we are in the process of accumulating much more knowledge about the market, and then in due time, we might talk to somebody who will have bigger muscles in that particular segment of the market.

Operator

And then we have the last question here. You had some remarks around the POC+ product in your annual report. Can you give an update on POC+ and the rollout of this system in 2024?

Jakob Knudsen
CEO, ViroGates

Is that mine as well? Yes. So, yes, we launched the POC+ quite a bit back in 2022. But we had to do some market testing, get additional handling data and so on before we actually marketed the product. And unfortunately, we've also seen that we had some issues with the product, some quality issues that we needed to address. So, right now, we've actually said with our partner, Genspeed Biotech in Austria, that we would try to fix some of those issues before we put it in the hands of healthcare individuals.

So right now we are troubleshooting that, and it's unfortunately a little bit difficult for me to estimate how long that process is going to take because it depends a lot on how much we need to change, whether it's a software, hardware intervention, or the actual assay composition down into the well of where our technology plays. So right now, unfortunately, we have paused the marketing of the product for a while, but we will get back and as soon as we are ready, we will put it into the hands of our customers.

Operator

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

Jakob Knudsen
CEO, ViroGates

Yeah, I guess the final remarks is that it's not as uplifting to present an annual report that has figures that are going the wrong way. Having said that, we look with a lot of optimism on some of the new use cases that we presented, and there's a lot of optimism in the office here around marketing those new use cases. So, we remain optimistic that the annus horribilis of 2023 is past us, and we look to a brighter future now.

Powered by