Good afternoon, and welcome to this half-year presentation with ViroGates. With us today, we have the CEO and the CFO. First, there will be a presentation, then afterwards, a Q&A, where the management team 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. Jakob and Josephine, your line is now open.
Thank you very much, Anders, and thank you for the opportunity to present our half-year report, which is fresh out, just released, I guess, 1.5 hour ago. With me, I have Josephine, as always, our CFO, and I will kick off the presentation with a more or less general presentation of our company, and Josephine will dig into the details of our latest half-year report. But I will obviously also point some of the most important developments we've had over the last first half. As some of you may know, but maybe new to other viewers, we were founded back in 2001. We are a company that has our headquarters in Birkerød, in an office community space.
We are about 12 employees, and we listed at Nasdaq in 2018, the First North Growth Market. We generally work with one biomarker called suPAR, and we improve patient outcomes and people's lives. So we work both in the hospital sector, but also in the private sector to try and improve lives among healthy individuals. We all know that global healthcare systems are increasingly under pressure, and a lot of companies are working under that macro environment trying to optimize things in the healthcare system, and so are we. We basically facilitate the sending home of patients, discharging earlier, and we also point to the ones that really need care to improve the lives of individual patients.
We have these macro factors on the left-hand side of the slide and also our solutions on the right-hand side that we will get a little bit back to. suPAR is a naturally occurring protein in the bloodstream of every individual. It's just a matter of how much we have of suPAR in our bloodstream, and that is what we are capable of measuring by ways of our products that are utilizing antibodies, traditional technology, to detect the level of this soluble uPAR protein in the bloodstream. suPAR generally reflects the immune system's activation.
It measures the inflammatory level, and, as some of you may know, the inflammation is basically the system, our immune system's way of acting upon something that is-- appears as, as, an unknown intruder to us, whether it's actually something that is going on with autoimmune diseases or something that is exterior, like an infection. But it's basically an alarm system acting to recruit other cells to try and help that rectify this situation that we're in. suPAR is also a strong indicator of and predictor of health in general. So, when we measure this chronic inflammation, we can basically determine whether we are on the right path with respect to the longevity activities that we are undertaking, and I'll get back to that use case a little bit later.
One of the milestones that we passed during the first half year was that we had more than 1,000 peer-reviewed papers. When I say we, that means basically a lot of international groups that have been utilizing our products in research, and those papers have been submitted to accredited journals, and they can be looked up at what is known as PubMed, where there's a description of all those studies, and that's a big milestone for us that we are now so acknowledged by all these peer-reviewed papers. The next slide that I show is also a relatively general slide. It basically shows suPAR's ability to predict survival. It's a little bit morbid, but survival is typically a good endpoint in many clinical trials because it's so binary.
Either we are alive or we are dead. So, hence, this is something that is typically reported. And this is an old study that we conducted, and where we looked at the survival rates in an acute care facility of the various levels of suPAR. So as you can see on the red line, you will see that a high suPAR above 9 ng/mL and 10 ng/mL basically indicates that there's almost 50% of mortality, i.e., the patient dying within 90 days. Fortunately, we are not so many of us admitted to an acute care facility, and with such high suPARs, the numbers that are the basis of that line are relatively small, but they are there.
We have many more individuals up in the 0 ng/mL-2 ng/mL or 2 ng/mL-4 ng/mL patients that are coming in where the immune system is basically capable of handling some of those challenges that they are submitted to. So this is underlying everything that we do, this general picture. The first use case that I'm gonna point to is one that we've been pursuing for the longest, so to speak. It's how we utilize suPARnostic in acute care. They are based on also some of the evidence that you show that you saw here. We can basically say that if suPAR is less than 4 ng, then everything else being equal, we can support a discharge decision.
Typically, a physician will also take other matters into consideration, obviously, before discharging a patient, but the physician can be relatively assured that the immune system is capable of working in to the advantage of the patient, and therefore, a discharge decision can be taken earlier. On the contrary, if patients have higher suPARs above 6 ng/mL , this is basically an indication that this patient is not really coping well with that particular infection, inflammation, inflammatory disease, and needs to be further examined and treated at the hospital.
This basically shows how putting suPAR on top of some of the traditional scoring systems that physicians are using work by distributing patients from the yellow box into some of the green, the green and the red boxes. If you look at the lower boxes, that is how the triage is done when there's accounted for suPAR. So many more of the green patients that can be discharged earlier, and also some that falls in the red category, but where we actually don't wanna make this mistake of sending the patients home. But the overall goal is to distribute the yellow patients into the other buckets. So that's data from a study that was run here in Denmark a few years back.
The next use case that I'm gonna point to is one that is relatively recent to us. It's how we use suPARnostic, not so much to find the ones that can be discharged, but the ones where we are guiding a specific treatment. And one of the reasons why we are happy about this is this is a more traditional way of using biomarkers, and therefore, it's a little bit more friendly to the ears of the customers in the hospitals.
What we saw in a recent study published end of last year was that in sepsis, i.e., this life-threatening condition, where we see the basically the inflammatory system being on overload, cytokine storms, way too much noise within the the system, and the risk it causes a really high risk of death, we can actually utilize suPAR to the benefit of the patient. And this relatively busy slide shows how this study was designed. Normally, what the physicians will do is to assess what is known as the qSOFA. It's a physiological score used to determine the severity of the septic patients when coming into the acute care. And a lot of patients arrive with a relatively modest qSOFA score of like one.
The typical reaction to that is to await further action and not to start treatment immediately. The idea and hypothesis before the study was to say, what if those patients have a really alarmingly high suPAR, i.e., above 10 ng/mL or 12 ng/mL of blood? Then they probably need more, more attention much early on. Therefore, a randomized, double-blinded study was conducted, where a control group was used to assess whether it was favorable to intervene early with antibiotics to the, to that particular patient group that had high suPAR. And that actually showed that those patients that got the treatment early, they had a much better outcome than the ones that had the control, i.e., saline water injected.
So, we can basically say that suPAR can be utilized to find the patients that are in need very much early on. This next slide basically shows also a way to intervene, and I use it basically because there's not so much focus on COVID-19 anymore, but we still have an ongoing collaboration with Sobi, Swedish Orphan Biovitrum, from Sweden, where we support the use of suPARnostic for their treatment, anakinra, branded Kineret, that have been made commercially available in the U.S. under what is known as an emergency use authorization. But they had a post-authorization commitment to make suPARnostic available to support that treatment.
So, what we announced during the first half year was that we had an FDA meeting under what is known as a Q- Submission scheme. It basically allows a sponsor of a trial, like ViroGates, to interact with FDA and have certain questions answered, and we had that with our collaboration partner, Sobi. We are proceeding well under that agreement, also with supporting the use of anakinra, Kineret, based on our suPARnostic products.
So we are very happy about that development. The last suPARnostic use case that I'm gonna show is, how suPARnostic can be used in general health, i.e., for the everyday population in a longevity setting to measure whether a potential intervention, whether it be exercise or cessation of smoking or the likes, can be assessed to see if our level of chronic inflammation can be brought down. There, we basically utilize suPAR to say, if we measure suPAR at any given point, and then do interactions like live more healthy, eat a healthier diet, do more exercise, and so on, we can basically determine whether that intervention is favorable to the individual. So, that is something that we are promoting quite a lot now.
It's one of our most recent, marketing and sales efforts, and, we have actually seen some effects from it. Josephine will get back to, to the exact numbers or the dynamics underlying the numbers. But, we have seen that the customers are, really happy that they have some sort of tangible measure to all of these, whether it be, vitamin pills, supplements that are taken, ice baths or whatever, to, try and measure, the, actual impact in the bloodstream. This, is also from a study that we ran here in Denmark, a retrospective study, where we looked at, what, is the effect of having a very high suPAR as opposed to a low suPAR for an individual, say, in the... at the age of, 60 years old.
So if that particular individual has a very high suPAR, he's biologically like a 75-year-old in terms of the development of cardiovascular disease, Type 2 diabetes, and also the mortality rate. So this we have converted into this biological calculator that is available at our website to see what is the adjusted age that you have as opposed to your the age that you show in your passport. What is the biological age that you have at any given point? So that's a quite useful tool to our customers when they're talking to their customers. And by that, I will hand over to Josephine.
Yeah. Thank you, Jakob. I will speak to our products, business model, and our team. So ViroGates has a broad product suite consisting of four different products that caters both to the acute care segment, the hospitals, as Jakob mentioned, as well as research customers and smaller healthcare clinics, which is our latest segment or the latest segment that we've targeted. And the first product that was launched by ViroGates is the ELISA plate. As we've noted here in the table, in the furthest down right side, it's typically for research use because it consists of this plate with many wells, and it makes sense to have many different blood samples to test at one time to make this an efficient use of the plates.
However, having entered longevity, we've seen that, in fact, whereas this was primarily a research product before, it has also become a bit of a longevity product in that these central laboratories that have an ELISA machine may run these tests for smaller healthcare clinics. So, this is a little bit of a shift in the ELISA use, as compared to what we've seen previously. The next product that was launched was the Quick Triage. The Quick Triage is a near-patient use or point-of-care product, in that you're able to measure the suPAR level in close proximity to the patient or to the client.
To use the Quick Triage, you need to do intravenous blood, and then you need to centrifuge the blood before doing the test, meaning that it's also a test that's suitable for a location that has a laboratory. And then, the following product that was launched by ViroGates is the TurbiLatex product. It's our turbidimetric product, which caters to the automated clinical use to the bigger machines or platforms that you have standing around at laboratories and at hospitals. And throughout the years since launching this product, we have validated it on several of these platforms, including those from Siemens and Abbott and Roche and Beckman Coulter. And then, in the end, is our latest product, which is the POC+.
As you might notice from the name, the POC+, it's also a point-of-care product as the Quick Triage, but the main difference between the two is that you are able to, with the POC+, measure your suPAR level based on a finger prick and full blood, so you don't have to do this centrifuge process that you had to do with the Quick Triage. The POC+ is currently under further development, so we're not currently marketing that product. We sell our products ranging from EUR 10-EUR 34 per test, with the margins of approximately 75%-90%. Yes. We sell our products through various channels. The main ones are direct sales, which are present in Denmark and in the Nordics, I would say, France, Spain, and Benelux.
Then we have indirect sales through a distributor network of more than 15 distributors that covers largely the rest of the rest of Europe, as you see in the black in the map. Then we have research use only sales to the rest of the world, but primarily North America. This is our management team and board representing extensive experience within life science and diagnostics and healthcare. Yeah. That was the more general part of my speech today. The next thing is moving on into the half-year report that was just published a few hours ago. Revenue for the first half-year of 2024 came in at DKK 2.276 million. It's an 11% decrease compared to the same period in 2023.
Underlining this fact that ViroGates is still struggling to get these hospital customers onboarded again, or to revamp these hospital customers that we had during COVID-19. It's a complex and lengthy process. As a handling measure, we are, as Jakob also mentioned, moving into this new segment of longevity. And when I say handling measure, it's because as we witness these longer sales cycles within the acute care segment, we have, from our preliminary entering into the longevity segment, witnessed that sales cycles in this segment tend to be shorter. So we're trying to hedge the long sales cycles in the acute care segment by also targeting longevity. And when looking at our operating loss, it increased with 11% compared to the previous period, the last year.
And our cash and our cash equivalents ended up approximately at DKK 8.7 million. Yes, and digging a little bit further into the numbers, if you compare the first half year of 2024 to the same period in 2023, you will see that, in absolute numbers, ELISA sales, which is the bright green in the bottom, were relatively stable, and that the decrease in revenue mainly stems from lower sales of our Turb product, which is the black or dark blue in the top.
What is worth noting again here is that, as I mentioned before, where we have traditionally seen ELISA sales as research and not as a kind of commercial product like that, it has changed a bit with our entering into the longevity segment since we witnessed these central laboratories that are servicing smaller clinics, also running samples on ELISA. So embedded in this ELISA sales, there is also both research customers, but also clinical routine customers in general health. Yeah, and looking at revenue with respect to geography, there is a trend favoring Europe as opposed to North America, which is rather different from what we saw in the first half of 2023.
This mainly stems, as we've also written in the company announcement, from the fact that we have some large research customers in North America that have placed orders, but smaller orders in the first half year of 2024 as compared to last year. And then we've had these new accounts within both the research but also longevity in Europe, pulling up the Europe numbers. And lastly, looking to our recurring customers, as you might recall, a year back, we changed our measure. So we put in a threshold. There was an existing threshold of having placed two purchasing orders within the year. We included a further threshold of having the...
An accumulated value of the two purchasing orders or more of above EUR 10,000, to kind of filter out the smaller accounts and focus on the ones that are recurring, but also, larger. Compared to the first half year of 2023, we ended the first half year of 2024 with three additional customers. We went from 14 to 17, but we have placed the in-between periods here. You see both Q3, Q4 from 2023, and then Q1, and you would probably conclude that the level or the number of recurring customers is relatively stable, looking at those periods as well. With both clinical routine customers moving a bit up and down, and the same to research customers.
But what we can see reflected in the numbers for H1 2024 is that we've included clinical routine customers within general health, so these larger laboratories that are recurring customers and purchasing, servicing smaller clinics, and that we've also added research accounts. Yeah, I think that was our going through for today. Looking forward to answer questions.
Perfect. Thank you for that, Jakob and Josephine. Let's move directly into the questions. The first question here is: You mentioned in your latest guidance update that you are focusing all effort on short-term revenue value. Is there a risk here that you end up sacrificing the best long-term possibilities by looking and focusing short term?
Yeah, I can address that. Obviously, there's also... There's always pros and cons when the hour or the day only has 24 hours. So, we need to.
To focus right now. We believe at what has the highest short-term potential, and that is to a large extent some of the, as you, Josephine mentioned, some of these longevity clinics. The downside of that is that they are they're smaller accounts by number. We believe that we can balance the risk of the long-term effects by ways of still maintaining relations with the hospital segments by ways of providing regular updates and this new use case to the hospital. So it shouldn't have so much of a detrimental effect. But obviously there's always a strategic question as to where we are directing our sales force?
Where are we trying to get our distributors to do the most? And there we are focusing on something that should hopefully get our revenues up on the shorter side of things.
The next question is, the new guidance is a significant downtake, and EBIT is actually lower than 2023. What specific changes are you making for the rest of 2024 to get a strong 2025?
Yeah, I can, I can answer that, or at least I can try. Well, first of all, speaking to the recent guidance and the overall level of EBIT, I think it's worth noting that when you as a company, as ViroGates had for 2023, have a year where your sales expectations are really challenged, you do not only bear the burden in that year, you also have these kind of spillover effects into the subsequent year. Meaning that, of course, going into 2023, we had sourced a lot of production based on what we have forecasted of sales. And when you have to kind of shift that expectations and that expectation doesn't materialize, you end up having a lot on stock.
So one of the reasons behind the level of this EBIT is, of course, that we have had to, during this year, to write off or to depreciate some of the products that we have on stock. And then, of course, looking to the future, we constantly look at where do we put our funds to the best use. Also, speaking back to our capital raise in the end of 2023, we have set aside loads of growth initiatives, as we also comment upon in the report. Because coming out of a year with a challenged sale, you need to. You can't just stop. I would say you need to also do new initiatives in order to foster growth.
So we've, of course, had a focus on putting the funds to good use, attending new conferences within longevity, trying to expand our reach with the distributors and so forth. And that cost does not necessarily always incur an upside on revenue immediately, so you have to sometimes wait a bit longer to see your initiatives pay off. So I would say for the remainder of the year and for next year, we of course have a focus on putting our funds to good use.
And if we stay within the guidance questions, there's a question more around guidance here. With your current guidance, it could mean a flat H2 compared to H1, but also a better H2. Can you say anything in regards to what you see in H2, and if you expect it to be better than the first half year?
Yeah, well, it's difficult to comment beyond the financial guidance that we put out with respect to our revenue numbers. And that, as can be seen, also reflects a span, and it is obviously also in lieu of previous guidances and so on. We believe that this is a reasonable amount. We, in the case that we do better, we will obviously be revising our guidance. But we do expect to see an effect of those shorter-term longevity efforts that we are doing.
I can say we're working with some laboratories in that setting, where we can sort of amplify the value of the individual customer, in the sense that the lab is actually promoting for us in a sense that they then address the small customers so we don't have to run to them one by one. And that we do expect to see an effect of. But needless to say, when we're talking small numbers and transitions in the segments that we're selling to, it is difficult to estimate. But our most recent guidance is our best bet at it currently.
You have DKK 8.7 million in cash. How long do you expect this to last, and what are you doing to lower the loss for the rest of the year?
Yeah, I think I can address that as well. Obviously, as we've said earlier, we are not commenting on our cash position slash cash expectations, cash flow positiveness. We do that also based on the fact that it is difficult not only to guide on the top line, but certainly also what transitions down. We will have to make some warranties as to that we're not commenting specifically. What I would like to say, though, is that as Josephine also mentioned, we do have some write-offs and so on that are not eating cash. So even though the EBIT is affected, the cash position is not as affected by that.
And we also have some cash flow effects from our collaboration with Sobi, where we, the model is basically that Sobi initiate work packages with us, and once they do that, they get an invoice for that work package, and we start working on it and so on. So that also has some cash effects that we will obviously then also accrue for in the accounts, but where we are not sort of following the normal model. To the last comment, also, about what kind of cost-cutting are we incurring? I think it's to Josephine's point, it's...
Running a company like, like ours, can't really be done successfully by sort of turning down the heat. We need to actually do efforts and be at the trade shows where we need to be, and so on. But having said that, I think we are really cost-conscious with respect to all the costs that are not directly thought to yield a revenue. Those will be heavily scrutinized. But the sales efforts, the market access that we've described for Germany and so on, those are activities that we prioritize still to run.
And then we have the last question here: It seems like you have a lot of evidence of the positive outcomes of using suPAR as an indicator. So the returning question, why is it so difficult to sell into hospitals and clinics, and what have you learned from this process to make sure that next year, the same time, ViroGates is a bigger and better company with a more efficient sales approach?
Yeah.
Sure.
I can start off.
Yeah, yeah.
You can comment afterwards.
Okay.
I mean, although you have been in the company longer than I, I think I've also drawn some experiences as to why the sales is difficult. It seems that although suPAR is a really well-researched marker, and as Jakob said, we've reached more than 1,000 studies at PubMed, the whole transition into using it in a clinical setting is a lengthy and more difficult or complex process, as you've also seen with many other biomarkers that are in the clinical field. Because you have to find the perfect balance between catering to the clinicians and to their understanding of how to treat a patient and how to use this biomarker in their everyday life.
You have to convince a laboratory that's running the tests on these big platforms that it's a good idea, and then you have to have a management, a hospital management, that can see the potential, also economically including this, as a biomarker for them to save on discharging and save hospital beds, for example. So you have to place yourself in the right balance between those kind of three parts of the organization. And then what we at least have witnessed with the whole sepsis use case is that when you put suPAR into a specific context to a specific disease, and when the use of suPAR points to a concrete action for the clinician, it rings a bell among the clinicians, I would say.
It's like it's a more well-known use of biomarkers as they use them, instead of just testing everybody at the acute care department. I don't know if you want to compliment.
No, I think you hit the nail on the head, I guess. But also having a little bit more tenure with the company, I probably have to appreciate that the acute care case, we still have, we still have a lot of love for it in the sense that we can help get the right patients into care and the right ones also to be treated outside of the hospital. But it may not be the first shot that we should take. So hence, the guiding treatment, as Josephine pointed to, is probably our Trojan horse, if we like to try and get into the hospital system. And then I think they will actually appreciate also that use.
I can come up with one example, a good example of it. We have a potential customer in Spain that has been wanting to onboard suPAR for quite a bit of time, and they have basically gotten it into the registry for use of sepsis like we described. But the reason why we haven't received the first order, we have this directly from our salespeople, is that the acute care physicians are actually demanding that they also have access to it. So that requires a different way of categorizing the biomarker in the system. So right now we are suffering from the fact that actually more physicians want our product, so I guess it's a positive sign.
But it unfortunately takes a little bit longer time. But I hope that this dynamic will also transition to other customers later on, that we will likely have the more acceptable way of utilizing a biomarker and then, this more novel way of utilizing biomarker subsequently.
Perfect. Thank you to both of you for answering the questions. That finalizes the Q&A. But before we end the webcast, I will just hand over the word for you if you have any final remarks to end with.
Yeah. I guess, just a, a big thanks to everybody who has been, listening and also to the ones that have, submitted questions. We really appreciate that you monitor us, and, and, we are always, willing to answer questions. So if you didn't get the, them answered here, please send us an email, and, and we'll try to respond to the be- the best that we can. Thanks.