Gentian Diagnostics ASA (GENT) Earnings Call Transcript & Summary

All right. Welcome to this Capital Markets Day for Gentian Diagnostics. My name is Njaal Kind. I'm the CFO of the company. We are obviously delighted to see so many of you attending here in Moss today. And we also have a significant number of attendees on the live webcast. So we are looking forward to present the company for you. Some practical information. We have about 2 hours of presentation. Due to the format being a webcast, the Q&A session will follow after the presentations. We will also have a break about halfway through. So you can top-up your coffees or have a snack. Here, we have the agenda, and I think I will just leave the floor to Hilja, which will make an introduction. So Hilja?

Thank you very much. Yes, as well a warm welcome from my side here to Moss and as well our participants online from the office or from home. I hope you can understand me. Well, perfect, sounds good. And as you can see, my role today is to introduce you to the company, to Gentian, followed then by to make a change by R&D and looking into the future, while we spent most of the day today then into the product, which we have in the market, the customers, the way how we go to market, which we call from science to sales as we are all based on science. And we will finish our program today then with the strategic outlook, which Njaal will cover, followed by the Q&A, as you mentioned, and as well by a tour of our facility, which is quite recently renovated and significantly enlarged. So with this, let me introduce you to Gentian. We are dedicated to the health care market. And within this health care market, there is a subsegment which is called in vitro diagnostics, and that is the market where clinical laboratories are serving clinicians to take treatment decisions. And we have identified as a company one permanent need in this part of the market, which is efficiency gains. Efficiency on the lab level, efficiency on the clinical level. And therefore, our mission, which brings us all together, which glues all the people in the company together is based on serving that need by innovating diagnostic efficiency to enable clinicians ultimately to take better treatment decisions. And the objective of our day to day is as well to give you more understanding of what that is. And -- but I start today now with the snapshot of the company. We are here in Moss, Norway, and we serve the world from here. We are a company which is acting globally. And in fact, we can serve every company in the world, but we do that, in fact, for many, many on all continents already. And why is this so? So in vitro diagnostics, these are reagents fluids, which are used on instruments, automated instruments, in most of the cases, in our case. And our reagents can be used on all kinds of instruments, which are already established in the laboratories. So with this, the barrier to change the introduction of a new reagent to the laboratory is much easier because they don't have to install a new instrument, purchase a new instrument, get all the trainings, et cetera, are done. And that is a significant reduction of adding a new marker into a laboratory, the barrier is gone, and therefore, it's much easier to address the needs of the entire world. In addition to that, we are, I would say, call it, still a smaller company in the market, still being already on a peer-to-peer level quite recognized, but our commercial footprint is limited by our move. And that means as well, you need in every country to speak some of the local language. So I cannot go from Norway to serve China. I cannot go from Norway to serve India and even the United States is English, we all speak well English, but it's a market which requires a well understanding of how processes are there, what the regulations are there. So therefore, you need local people. And that is what we achieve with our go-to-market model that we are working with partners who have the instrument platforms in the labs anyhow. And they are competing against other instrument platform providers. And guess what, the menu, the reagents they offer is part of this competitive advantage or disadvantage. And here is where our play is. Yes. We have, based on this, achieved NOK 112 million in 2022 with about 50 employees, the majority of them located here, and you will see probably today, many of them. And speaking of a public company, as you all you know, and speaking about the employees, I would like to highlight with the example of our management team, the diversity of our team in terms of gender, but as well internationality and the background we have coming from [indiscernible] starting the company as a co-founder with Aleksandra, who is here in the room and who is still supporting our efforts in the company. Keeping as well people who work many, many years together with Njaal and keeping that experience and knowledge and bringing additional knowledge to the company working as well in bigger companies, knowing what it means to serve bigger companies. process understanding, how do they buy, how do they sell? And that explains as well why you may have seen an increased number of company contracts, partnership contracts we made because this is a quite complex organization to work with Roche or Abbott or Beckman Coulter. You need to find the right people and when you find the right people, find their time and they need to find somebody who can sign because a signal chain such a big company is not so easy to get. So with the experience we brought to the company, that is one example, which helped a lot to get more of these contract sites, which are ultimately the basis for the growth now but as well as the growth in the future. I had spoken to many of you about my passion, which is a diagnostics market. I'm a microbiologist myself, but it is a market which is not so well known and well understood. We are already in the room probably patients here and there. And you know what a clinician is doing. But when they draw your blood when they are asked for other kinds of parts of your body, you don't know what happens with this. And most of these specimen or samples are going into a laboratory. And that part then of the market where you don't deal with a living patient, you take a piece of the patient, it's in vitro because you are now in a tube, and that tube is analyzed in a lab. And in that lab, there are symptoms you have expressed. So with this knowledge of symptoms, or with this knowledge, I want to know that I'm pregnant or not pregnant. So these kind of questions, the lab knows what to analyze, what kind of markers to look for in order to support the clinicians, finally with the result with the final diagnosis. And that kind of interaction is happening when patients come with symptoms. It happens as well when you want to avoid as a government to avoid disease and doing screening programs. So you on a general basis, have certain checkup procedures like colon cancer screening in the order to avoid that you will get cancer, finally. And finally, you use it as well to monitor the treatment. So the diagnosis is happening, thanks to our product as well with most likely better treatment, but you want to monitor is the treatment really working? Is it fast enough? Do I have to add something? And the results of ours, but as well other biomarkers, support clinicians to take a decision, good treatment or no, I need to just fine-tune or stop as well as the treatment because the patient is healthy, can go back to work. That is in vitro diagnostics. And it's a lot of technology out there, from microbiology to molecular diagnostics, including immunoassays. And the immunoassays is our space. This is our technology expertise, which started with Erling. There's a lot of protein and biochemistry knowledge you have to have what happens in your body because the biomarkers you have in your body can indicate to a clinician, yes, there is a disease. There is an infection. There is a kidney failure. And you will hear more about that in a minute. We have mastered in the meantime, a technology within immunoassays, which is called PETIA, particle-enhanced turbidimetric immunoassays which allows to do a very sophisticated test, which requires until today for many, many biomarkers, sophisticated instrumentation with a lot of reagents, a lot of rushing steps, a lot of time, a lot of money to put that on the clinical chemistry analyzers, which are the most simplest, but as well the highest throughput test, fastest, you have much faster time to result as well. And mastering this technology enables laboratories to become more predictive and providing results faster to clinicians, which again, enables them to take a better treatment decision. This is our story and our part in this market. Speaking about the product, we have several products addressing different diseases. And this is not our #1 decision-making when we look into a pipeline. It's not the disease area. It is where can we add the efficiency from a clinical point of view or from a laboratory point of view. And we have products which are in different phases in their maturity in the market. So how well recognized are they in Europe, in the U.S., in Asia, in Africa. And so here, we have the so-called established products, and you will hear that word more often. And we will focus today a lot on these established products which are Cystatin C and fCAL. We have as well Canine CRP, which is further down and fPELA. So we will speak very briefly about fPELA, but the majority of time we will spend today on Cystatin C and fCAL because they are driving currently our growth, and we assume as well for the future. They are significant, important for our growth strategy. We're going to talk as well about GCAL, which is on the edge from market development into -- I would not call it yet established products. But the understanding, the awareness of clinicians and laboratories about the power of the of this biomarker from serum and plasma is increasing, and you will hear more from Aleksandra about that. And obviously, we will give an update on NT-proBNP, which will be part of Torsten's presentation on our most important pipeline project. Yes. So in end of 2018, early 2019, we have started with the team to develop a growth strategy. And it's now important as well, which we have -- and we will speak more about our growth strategy, is it really working because the strategy can be wrong or the execution can be wrong. But so far, when we look back now, we have achieved a compound growth rate of 26% for the total revenue. It's even higher when you look only to the product sales. And that is -- it's okay with our ambition. We always want more. I want always more, but we are quite proud about that. And in addition to this, we have achieved significant contracts with Siemens, with Beckman Coulter, Roche and others which don't want to be named and more of that and the ability to be -- to do those kind of long-term contracts. So these are the cornerstones of our strategy, and therefore, we are confident about our vision and our plan. And speaking about that, that will be my final slide before we get them into the details is our strategy is based on our established products, which I mentioned before, our -- we believe that we achieve 20% or more on an annual basis, busy established products. And I hope you will agree at the end of this afternoon with our assumptions and estimations. We continue to prove the clinical relevance of GCAL and translated more and more science into sales. We focus on the development of NT-proBNP, which has as well a significant piece in our growth strategy. We have as well more product to add to our growth strategy as well, that is part of it. The commercial partners are getting more on board or with one -- several products into the -- under contract is an important part because having a product developed is okay, but you have to sell it at the end of the day. And here, we have just to say a little bit what Markus will explain more in detail. We start with direct sales. We, as a company, want to be in touch with customers directly, and we have several ways of doing that. And with this experience, we know if we serve the needs and we create a certain push to our commercial partners because those customers will speak to the Roches and to the Abbotts in this world and say, well, there's a new biomarker or there's a different way of testing that biomarker, you may want to look into that. That is a little bit the way how we do that. From a financial point of view, we aim to improve, of course, our margin from currently 50% to 60%, mainly currently based on volume. There may be even other means to gain margin, which is not yet in our focus because our focus is profitable growth. And profitable growth means that we are looking for an EBITDA margin of 40% within a 5- to 6-year time frame, right. Njaal, You will speak more about that. And yes, so with this I hope I made you a little bit more curious about what is really behind all of that, nice ambitions. And I -- as I said, we for a change, we start with the future and then getting to what is today. And I would like to ask Torsten. Dr. Torsten Knüttel, our VP for R&D on stage to talk a little bit about our future growth.

Yes. Thank you. So I take with me some water. Can you hear me? Yes. Okay. Yes, R&D. So I'm the leader of the research and development department here at Gentian Diagnostics. You may be hearing it. I'm not Norwegian. I'm German. So my wife is Norwegian, I moved to Norway 20 years ago. My background is in chemistry from University of Hannover. Started at Emerson Health, which became GE Healthcare back in 2004. And then after 11 years, moved over to Thermo Fisher Scientific business development. In GE, I was working in different goals within research and development. And after Thermo Fisher, I moved back to research and development when I got this opportunity to work closely with Erling and leading the R&D department. That was back in the summer of 2019. Erling and I, we know each other for many years already. When I moved to Norway in 2002, I already started to talk to him. And later in Thermo Fisher, when I was working in business development, Gentian was my customer, right? So there's always a good connection to Gentian throughout the years. So today, I will talk a bit about the department. What does it actually mean research and development. Usually, you just say R&D, right? But there are differences between these 2 parts. Then moving over to the different phases within product development. And then in the end, of course, NT-proBNP, where are we and where are we going? So with this, I think we can start with the team organization and the capabilities. Overall, we are 13 people within the R&D team, quite an international team, seven nations and all with a high education, at least on a master level within life sciences, biotechnology, and 8 people, I think it's 8, right, have also a Ph.D. So a lot of expertise. People have been here for nearly 20 years, but we also have attracted people from different diagnostic companies like Abbott, like Roche background, Thermo Fisher Scientific like myself, and GE Healthcare. So altogether, the group has 11 patents. These can be Gentian Diagnostic patents, but also patents coming from their pharma, life experience. But showing that these are people who have a very creative mindset, that's what you need in R&D. As I mentioned earlier, research and development, there's a difference. In research, it's all about networking. You need to have the connections, you need to know the key opinion leaders, you need to know maybe a university or a corporation partner, having a new exciting biomarker. And then you have to have the mindset. The people once you start something, probably, it's not working. If it's working, you're lucky, right? But if it's not working, okay, you fail and then you start again and you start again and you start again. And this is a special mindset in the research part. And not everybody has that. So you need to have the right people in place, and in addition, intellectual property. You need to judge -- maybe this is worth for a patent application or shall we keep it as a trade secret or maybe we just make a publication to block others. So there are also the strategy behind it. That's what you do in the research department. Once you move over to the development part, the necessities are a bit different because the project is then derisked. You establish the project group, you have a budget, and then you need to have a different mindset because it's more about the rules, the guidelines, the compliance, documentation, IVDR, in vitro diagnostic regulations. These are the things more for people who have a list, who know what to do, they need to be in compliance. Because suddenly, once you move over to a later stage from optimization to verification, yes, my colleagues from QA are bunking or knocking on the door, and they say, hey, once the specification are set, you cannot change everything, right? If something is not working, you cannot just go back, then you create a lot of work for documentation. So quite a difference between research and development. And of course, we are serving different platforms. As Hilja said, we are on the open platform strategy, meaning we not just have a Roche, we also have Abbott instruments. We have Siemens instruments. We have instruments from Mindray. So if you're thinking about these companies, a lot of these companies have also their assays, but on their own machines, right? And they are working on this assay on their own machines, but we are serving all the different machines. So we need also to have people who are comfortable establishing our products on the machines, but also traveling maybe to customers who have maybe more exotic machines, right, and set it up there. So they pick their [indiscernible] or their suit case 2 weeks at the site, setting it up at late hours. Moving over to the approach of product development. So you see, again, research, development, launch and life cycle, I already explained that there are different phases between the different departments. In early exploration, it's all about getting ideas, making theoretical evaluations about new biomarkers, maybe test something and then moving over to the proof of concept where you really start to try to test the feasibility. And then we are handing it over to the development people to the development part and then you're going to the optimization phase. And here, really, it's -- you need a lot of focus. Because in this phase, my colleagues say, okay, thank you, research. Something is working, but we need to optimize it. We need to make it robust. We need to be able to upscale it. Also then more and more people from the operations department are coming in on the scale up because you cannot have enough to have it in a small glass, it needs to be also in bigger reactors thereafter. And then you move over to the verification phase. As I mentioned before, then this change control from the QA department kicks in. You set the specification, you have the recipe, everything is locked. It's not so easy then to change anything anymore. You create a lot of documentations and a lot of work. So you need to be sure that in the optimization phase, you got it right before you move over. Validation phase in the end here, you already start with clinical trials, right? IVDR has kicked in, in the last year. So you need to do clinical trials, prospective, and here, you really need to ensure that your product is already working stable. Now if you send it out, you do these validation studies, the labels need to be ready, everything is tested from start to finish. And then of course, you have the launch and the life cycle, you need to serve the customer for many years thereafter. So each phase has also different challenges. I don't want to go through every challenge, but in the early phase, you need to ensure is it feasible at all. And you have the antigen, the biomarker, maybe you want to produce antibodies from the chickens, is the antigen actually available? Maybe you need to synthesize it, right? All these thoughts need to come into consideration so that you can start as early as possible. Samples, are clinical samples available? We are using -- maybe my own blood can be used, but hopefully, I don't have the disease, right? But to test it very early, you need probably some blood from diseased people. So these are called leftover samples. And Erling and I, we have visited quite a lot of hospitals, right, to talk to the physicians and get left over samples. You can do that through the Norwegian Research Health Act. But of course, it's always difficult. But we enjoy talking to these people. So it's always a good experience. Assay development, scale-up, I already mentioned, can be a challenge. And of course, with open platforms, you need to serve the customer for many, many years. And maybe there are platforms who are quite exotic. But nevertheless, you need to be able to serve them and set it up for them. Overall, for a time line, I would say, from the experience 18 to 36 months for assay development. And then you see the different chances of launch, meaning that you derisk the project and the product development throughout the different phases at the end of proof of concept, roughly 50%, and then at the end of optimization, roughly 70% until you launch it and then you can be ensured that you have something which is stable and works. On the next slide, it's more or less the same, but a big information about the different products, the products in development, the products on launch already in the market. To the left side, it's just a list, right? That's where the ideas are coming in. You are talking to key opinion leaders. You maybe have corporation partners who give you access to a new biomarker. It's more of a theoretical evaluation. Sometimes you test something on a very small scale and always make prioritizations until you said, yes, this is the one moving over into the proof-of-concept phase. Currently, we have 2 markers in proof-of-concept. Then as you know, we have NT-proBNP in optimization and then our 6 products already on the market. Over to the next slide, NT-proBNP, still a very strong value proposition. Just as a reminder, NT-proBNP is used in the diagnosis of congestive heart failure. And the Gentian test will be the first turbidimetric test available on the market, serving the need for high sample throughput. So up to now, there are [indiscernible] on the market, but they still are more on the lower throughput side, as you can see here, 700 samples per hour. With the turbidimetric test, we can go up to 2,000 tests per hour. In addition, throughout the units, we learned that the NT-proBNP molecule is glycosylated. It has sugars in different areas of the molecule. And this creates differences in results on different platforms, on different tests available. And with our test, we will enable an instrument harmonization throughout the different platforms and also standardization. And there's already a strong commercial interest. It's not a new biomarker. It's very well known for over 20 years. So we are not starting with something totally new, which is great. We are transferring it on a new technology. So Markus already put some money in its hand, make a market investigations with very interesting and good results. And we already have some communications with selected global IVD customers. So we are opening us up already a bit. You know R&D, we are very conservative, oh, it's not there, but okay, let's talk to people. And it is very good discussions, and it's really exciting, I have to say. And they are also really interested and want to continue to be updated about this. Other positive news. We got a patent already in the U.S. It was announced earlier. It was now in 21st of March this year. So we got the first patent in the U.S. And still, we are working on and continue with another patent in the U.S. to have this flexibility and open up for a further developed assay. That's the U.S. In Europe, we are also working on a -- with a pending application against the European Patent Office. And here, we expect a granted patent roughly '24-'25 in the U.S. for the second, maybe also within 24. So for the U.S. one, it can be maintained with this until 2041. And for the European one, once we get it until 2040. So this is great news and just gives us a recognition also from these offices that we are doing something meaningful and new novel and inventive here. I think this is my last slide. To sum it up, I already mentioned it, we are still within the optimization phase. But again, we need to take us the time to make it right within this phase to be ensured that we will move on into the verification, validation phase. Still, we will be the first turbidimetric test on the market, which is very attractive. We made a good process -- progress and established a simpler and more effective calibration method. So the work there is ongoing. In addition, we enjoy quite an advancement in the stabilization of the working prototype, meaning you have the latex with your antibody. It needs to be stable. It cannot dissociate then it's not working. So the team did a great job really ensuring that this is more and more stable because once you have something stable for many, many weeks and that's where we are, then you already can start maybe, we have real clinical samples already available. These are clinical samples from university, hospitals, where we also get the clinical information. It's not just the leftover samples. So these are rarely available samples, and we are eager really to investigate the performance of the working prototype on these samples. So we are starting and we are planning for this. And in the end, once we are out of the optimization phase, we anticipate 6 to 9 months throughout verification and validation and then 6 to 9 months with in vitro diagnostic regulations. This is a bit of an X factor, right? It kicked in last year, regulations with clinical trials. And it's a -- yes, you have the notified body for us, it's [indiscernible] in Germany. And you cannot be ensured how long it will take. That's why we anticipate here 6 to 9 months. I think that was my last slide. Thank you very much for your attention. And with this, I hand over to my colleagues, Aleksandra and Markus. Thank you.

So pleasure to welcome you here as well from the commercial side. I managed the commercial activities in Gentian having been here 3 years now, and we'll dig deeper into the commercial aspects during the next couple of minutes, and also introducing Aleksandra.

My name is Aleksandra Havelka. I'm Chief Scientific Officer. I joined Gentian in 2017. But before that, I had a collaboration with Gentian, with Erling and the team for approximately 10 years in developing fCAL turbo assay that we will talk about today when I was working at Karolinska Hospital.

Great. So let's get into the matter. I hope this works. Yes, it does. In fact, this slide shows the products that we actually sell. And when you do the facility tour, you'll actually get a little bit hands on to understand what the products are that we sell. So the products are these containers in which we have our liquid assays. Now our topic here on the commercial scientific side is from science to sales. So we follow the science that we bring products to the market, which actually responds to a commercial and a patient and clinical need. So we don't just make products because we can or because we have fun, but because there's a need in it. And you have seen a list of products that we already provide. And this is the list. Cystatin C established in 2006 quite a few years ago. We talked more about their product because it really has great potential still even though it was launched quite a few years ago. And cCRP launched 2012, fCAL turbo, GCAL. So we have a nice list of products, which we have been able to launch into the market. Today, later on, we'll focus more on 3 products, which explain the approach that we have been taking and that we're convinced that we can apply to our new products that we are developing. Okay. So some historic sales, just to give you some real sales data here. We've divided it in 2 areas. So we've got, as Njaal mentioned and Hilja mentioned, we have 2 major products, which drive our commercial success up to now. It's Cystatin C established 2006, and it's fCAL turbo, which we commercialize with our partner, BÜHLMANN from Switzerland. And what you see here, you look at the scale, we are in the NOK 40 million range of annual sales today, and we have compounded average growth rate of 20%. And -- but those -- so they are the largest product, but they also grow with 20%. So they are obviously our breadth in our commercial efforts. And we may not have shown enough in the past about the success for these products. So that's one of the reasons we talk about it today. On the other hand, the products which are not at the same level in terms of sales revenues, these are our products. GCAL, we'll talk more about this very promising biomarker and assay. We've got fPELA, which is also a fecal testing product. We've got an interesting veterinary market product, which is Canine CRP. And we should not forget that we have a commercial organization in the Nordics managed by Aleksandra as well, which has driven sensational growth in the past. So those are the elements you see the growth rates, 70% for the smaller products, but we start from 0, right? And then up to 35% in the -- in Gentian AB in the Nordics. So this kind of historically shows our success. And yes, we have doubled our sales within the last 3 years, I think, and that's in a difficult environment through to the pandemic. And none of the sales were driven because of COVID testing, by the way, right? If you now look at the results from many of the large companies, you name Roche, Abbott, Siemens, they all have challenging times because they're losing the COVID business, the COVID testing business. We have been able to grow our business without any COVID business in a difficult time. So I think that's also a nice story about it. Now one thing to mention here is Hilja already mentioned our commercial approach. We call it smart commercial model. There's not going to be 200 Gentian sales reps in the world or 500. That's not going to be successful. We multiply our sales through partners. That's the way to do it, also based on the fact how the industry works with large established players, Abbott, Roche, you've heard those names before. So -- but it's key, global diagnostics companies, and we've been able to achieve contracts, partnerships in the last 3 years, and we have still a few on the pipeline. That's one pillar. The second pillar is specialized local distributors. You need to get to the market before the large companies are interested in any of your products. So we have a number of distributors in Korea, in Germany, in France who already start to commercialize the product within local markets, but they're very often specialized for this type of business, for this type of segment. And then finally, we do definitely have direct business with health care institutions. We do have it through Gentian in the Nordics, which is very, very important because customer intimacy, understanding what the needs are very important so that we decide and prioritize which products do we actually need to develop and bring to the market. So that's very, very important. We do have also sales individuals in the U.S. The U.S. represents 40% of the global market in IVD. So this is really a success factor. And we've been very successful in the last 2 years in the U.S. So we do have an individual in the U.S. At the same time, we have a partnership in China through Beckman Coulter, and we have one person in China to help us managing that relationship. So the combination of those 3 pillars, yes, we have direct access to critical institutions that like our products, require our product, but give us feedback what to develop. And at the other end, we have the large diagnostic companies who multiply the sales of our product. That's our commercial, smart commercial model. What are the market needs? What are the pain points in the market? Number one, and the pandemic has really increased that a lot is a severe shortage of lab staff. There are other areas in the economy where there's an issue. In diagnostics, it's very, very, very severe. And it's not only the number of stuff, but it's also the qualification of stuff. What that means is you're looking for high productive products, automation in the laboratory. And our value proposition totally responds to that need. Secondly, cost pressure. As always, health care costs are skyrocketing. So we provide products which actually offer cost benefit. They're more productive, more samples in less time. And also they are -- we're positioning the product very competitively so that you see a cost benefit. At the same time, at the other end, you have the clinicians and what they want is the best possible results so that they can treat the patients better, faster, et cetera. So these are the drivers that we respond to with the product that we bring to the market. So the 3 products that we focus on now is Gentian Cystatin C, which is really our legacy product. And I said from the beginning, this is a really -- this is a very, very promising product for the future. And I think we can prove that. Then through our partnership with BÜHLMANN, we've got the fecal testing products. And finally, the product which is kind of on the verge between market development and starting to be as established product is GCAL. Those are the 3 here as we'll be talking about in a little bit more detail. And the first one is actually Cystatin C. Aleksandra?

Yes. So what is Cystatin C? Cystatin C is a biomarker that can detect kidney dysfunction in a very, very early stage and it can prevent severe kidney failure. There is one competitor on the market for the Cystatin C and that's a biomarker called creatinine. But that has much higher value than creatinine, and it's gaining momentum in a clinical world and in the world of diagnostics. So what are the advantages of Cystatin C when you compare this biomarker to creatinine? As I said, early detection of kidney function. 90% of people with the kidney failure are not aware that they have disease because it's symptom-free. So you don't feel it until it's too late. So with Cystatin C, you can detect it much, much earlier than with creatinine. Another big advantage is that Cystatin C is not affected by body mass, race or diet. Creatinine is affected by all these factors. So you cannot use creatinine in children who are growing and the body mass is changing. There is difference between boys and girls when they reached teenage. You cannot use it in patients with malnutrition, elderly patient, anorectic patients and amputees. So there is statin of very high value and creatinine cannot be used. Creatinine is also dependent on race. African American, they have higher creatinine levels and they have 3x higher incidence of kidney failure. So it's very important to diagnose these people in a correct way. And here is Cystatin C, the better choice. Creatinine is also dependent on the diet. If you eat meat, you cannot take a sample and measure creatinine because the levels will be higher. So there are many advantages of Cystatin C compared to creatinine, and we need to convince the world that this is the case. And we are not alone. We see that the clinical adoption of Cystatin C is high in Europe and increasing in other parts of the world. I think this is your slide, Markus.

So I mentioned it's really our legacy product, and it was introduced in 2006. This is kind of if you want the wall of fame of achievements for Cystatin C. One of the products, if you think about it, achieved FDA 510(k), I mentioned again, the U.S. is biggest market, already then very fast registration for the product in the U.S. which was the basis for being able to have a first global contract with Beckman Coulter very early on. And still after 15 years, Beckman Coulter is a very strong partner for us in commercializing the product. From a regulatory perspective, Torsten mentioned IVDR, this very tough new regulation to certify in vitro diagnostic products, which came into the market last year. So we registered the product and not just that, by the way, all our established products, the IVDR certified in '22. Just to give you a number, how many tests do we produce? So last year, we produced 10 million tests for Cystatin C, just to give you kind of an order of magnitude, right, with a large portion going to China, by the way. Yes, we achieved NOK 40 million sales in 2022. So I think that gives a very nice traction commercially. And I mentioned Beckman Coulter. They were the first partner, but, hey, there's many, many other companies out there that require that product. Something maybe to understand is that if you look at the large corporations, Roche, Abbott, they are looking for the big sellers. They put investment in development of products that provide [ 50 million, 100 million ] revenues. So they have to prioritize which products they develop. Some of those products may not reach that. So they are looking for partners that develop products such as Cystatin C, but they can put it on their own menu and complete the menu and be competitive in the market. So there's other companies out there, and they don't want to be named, but we have agreements in place for some other large global IVD companies for Cystatin C. And in fact, I think what differentiates us is Gentian with Cystatin C product. There's other companies that have that. Roche has a Cystatin C. Siemens has a Cystatin C. We're dedicated and somehow Gentian is [ phenomenous ] with the brand and with the product Cystatin C. Very highly competent to support customers, clinicians understanding the assay is very important. Our product was used for standardization. Torsten mentioned that NT-proBNP is a product which is not standardized yet. Cystatin C is standardized and the Gentian Cystatin C product was used to standardize it. That's a differentiation. Overall, the product as such is highly visible. When we sell the product through Beckman Coulter. It actually -- it is brand of Gentian. So we have a lot of recognition in the market for our product even though it is distributed through other partners. Yes, highly engaged with subject matter experts around Cystatin C. And we're highly active with association that want to push the product or are active in kidney disease management. And you will hear more about that from Aleksandra as well. And yes, 40% of revenues associated with Cystatin C. So it's important that this sales level is maintained or as I'm very sure will grow significantly in the future. Market, what's the potential? So currently, the market is around USD 100 million, which is in the IVD business, yes, not huge, but interesting. But due to a lot of changes in the market, new recommendations that Aleksandra will talk about, the market will grow significantly. According to market research, but also to our estimations, it should be more than doubling in the next couple of years. And we'll explain why we believe this is going to be the case. Aleksandra?

Yes. So as we already said, there is a momentum for Cystatin C. Clinicians are aware of the advantages. And now international organizations are including Cystatin C into the guidelines and recommendations. And here is a recommendation by American Society of Nephrology, a National Kidney Foundation for increased use of Cystatin C and in plasma and serum. And as I mentioned before, many people, they are not aware that they have kidney disease, and there is 37 million adults in the U.S. and 90% of them, they don't know that they have kidney dysfunction. So Cystatin C is a very important biomarker for early detection of that disease. There is another big international organization, KDIGO that is updating their recommendations in 2023, again, suggesting and recommending use of Cystatin C more than it's used today. Gentian has a very strong network with global key opinion leaders that are supporting use of Cystatin C. In this slide, you can see pictures for two webinars that we have organized. On the left side, you see webinar organized in collaboration with top key opinion leaders from United States. 2 of them are also our routine customers where they discuss the value of Cystatin C compared to creating in the estimation of glomerular filtration rate or kidney function. And the other picture is interview that we have performed with Anders Grubb. He is one of the first pioneers and very strong supporter for use of Cystatin C. So we have strong support, and we have a very good network globally that talk for the value of Cystatin C in disease of kidney failure.

Thank you. So we're convinced that Cystatin C will continue to be a very strong product with high growth, maybe even higher growth. But really the momentum and it's really following the science. It's really the recommendation to use the product because it means better treatment of patients. Just to give you a number, in the U.S., there is 700,000 people on dialysis constantly. The cost for 1 dialysis per year per patient is in the area of USD 60,000. You do your calculation. With better diagnosis, you can prevent, not all of it, of course, but there is a significant impact of better treating and preventing kidney failure with dialysis or even kidney transplantation. So the momentum we think is there, broad endorsement from the scientific community and adoption of the assay in routine lab in the routine lab environment, driven by recommendations. And we are engaged with these institutions that support and drive those changes because also the way we are known and historically with the product. And we have a very high and very intensive discussion and interaction with our business partners. What you see here, for example, is the flyer by Beckman Coulter. They have started an initiative in 2022 in the U.S. to really commercialize the product in the U.S. much more -- with much more effort compared to the past. So that's why we're very positive about that. Good. How are we doing in timing? One more? Good.

Okay. The next product is fecal calprotectin test, fCAL turbo. So fecal calprotectin is used to diagnose inflammation in the bowl, inflammatory bowel disease. With this biomarker, you can reduce the need of colonoscopy, endoscopic examination of the car. If you have done such examination, you know that it's invasive, it's not very pleasant, it is not risk-free and it costs money. In U.S., most of the patients they have anesthesia. So they are doing that the examination when they are asleep. And if you include anesthesiologist in this team, the cost is very, very high, and we will talk about that a little bit later. So Markus, I think you should talk to this slide.

So in summary, the product fCAL turbo, it's an assay which was introduced in 2015. So we've got 8 years in the market, by the way, together with our partner, BÜHLMANN from Switzerland. They are the commercializing organization for this product. Again, our benefits, this is a platform-agnostic product, which means you can implement it on any kind of clinical chemistry analyzer. And we are in a market environment of about 80 to 100 --- or similar to Cystatin C, by the way, right, USD 80 million to USD 100 million. And the current segment share that BÜHLMANN enjoys with us together is about 15% to 20%. What is going to drive the growth? Again here, we have regional expansion. We have adoption in guidelines, and we are also in the process of -- BÜHLMANN, in fact, is in the process of competitive conversions. Historically, this test was done with cumbersome manual intensive work. And obviously, this is exactly opposing the needs of the laboratory with lab shortage, need for automation, et cetera. So that's one of the reasons why growth is going to continue. And last but not least, acquisition of global partners, like in this case, Roche, which is #1 in the diagnostic industry. They don't have that product, but we have a long-term agreement for Roche to provide the product.

Yes. So our assay is adopted to automation, and there are several competitors which have automated assay on the market. But our assay is the only assay on the market with full automation potential from sample collection and extraction to analysis. And that means that we have a collection tube -- we are the only provider with a collection tube that you can give to patient and patient can do sample collection and extraction at home. When they send this tube to the laboratory, extraction is done on the way to the laboratory, when laboratory received the tube, they can just put it on the instrument and measure calprotectin in stool. So there are no hands-on stool samples in the lab, and you can imagine how popular it is among our customers because it's not very appreciated task to extract stool samples all the day. So we have asked 2 of our customers from Sweden, what do they think about our solution after implementation of this patient performed extraction. So you can see that one of the customers when we asked what was the challenge with your previous routine, they say that extraction time was -- extraction was time-consuming and it required 1 technician or engineer to work with stool extraction the whole day. And today, with our solution, they have decreased that time from 1 day to 2 hours, so they can definitely recommend this solution. The other customer that we asked they say that, oh, but now we have time for other tasks, and this is absolutely crucial in times of staff shortages, and we have very nice workflow now. I am very happy to tell you that we have recently signed a contract with a big laboratory in Norway, Fürst Laboratory. So they will -- we will now be a provider of fecal calprotectin, fCAL turbo and fPELA assay to Fürst. And Fürst is very big customer. So we are extremely happy to be able to serve that customer with our products. Yes. And again, guidelines, recommendations and adoption. So why are guidelines important. They are important because with the guidelines, all patients will receive same level of care. The diagnosis and the treatment will be standardized. If a biomarker is in the guideline, it means that it's endorsed by clinicians. And it can also affect insurance reimbursement, of course. So the aim is to get the biomarker into the guidelines and recommendations. And in Europe, fecal calprotectin is well-established routinely used biomarker for inflammatory viral disease. In the U.S., the process has been slower, but we are getting there. There are 2 big associations, American College of Gastroenterology and American Gastroenterological Association, which now recommends use of noninvasive biomarkers, including fecal calprotectin, which is actually the best biomarker compared to some other inflammatory biomarkers for use in patients with inflammatory bowel disease. I mentioned the costs for colonoscopy. So it's not just inconvenient, it's also connected to high cost. Cost for one colonoscopy in the U.S. is $2,750. If you need to put patient on anesthesiology, then it's even more expensive. And the cost for fecal calprotectin assay is USD 25 to USD 30. So you can imagine the cost savings you can achieve by using a biomarker and fCAL turbo test compared to doing a colonoscopy. We said that we will mention fPELA assay just shortly. And the reason for that is fPELA is assay, which is used to diagnose disease of the pancreas. And many patients with pancreatic exocrine insufficiency. They have the same symptoms like patients with inflammatory bowel disease. So they have a blood in the stool, they have diarrhea. They go to doctor and then doctor take fCAL turbo and fPELA test to exclude pancreas disease and confirm or exclude inflammatory bowel disease. So these 2 assays are often measured in the same patient. So we have -- we are taking a step forward in our aim to improve diagnostic efficiency. So we have fCAL Turbo, we have this collection tube, and then we add fPELA essay, which can be measured in the same tube. So patient doesn't need to take 2 stool samples. They don't need to perform 2 extractions. You can measure both assay from the same tube, which is again proving our strategy to improve laboratory efficiency and serve our customers with something unique that other competitors don't have. So I think, yes, we're half through.

It's time to have a break, right, for coffee, drinks, bio-break whatever. We have what, 10, 15 minutes. We'll continue with GCAL, A Last word on fecal calprotectin, I know the last time when you have been into a diagnostic lab and you have talked to people that work in the stool lab. This is not the most favorite place people want to work when you have to handle stool samples. So a solution that, that where you actually don't get in touch with it is a very, very nice solution for the workflow, but also for the lab environment to work. So I think good reason that first has chosen this product. So we'll take a break and see you in another 10 or so. [Break]

So we heard you already had some questions in the break. Obviously, if -- I hope your notebooks are full of questions also for the Q&A session. But we still have a little bit more to talk about before we finish with the Q&A session. And the next product, which we are talking about is a product with a lot of potential. -- which is our GCAL products, Aleksandra.

So yes. So we will take you on a very exciting journey from science to sales and talk about GCAL. Our assay which can be used to measure calprotectin in serum and plasma and calprotectin is a fast and accurate biomarker for detection of infection and inflammation and detection of severe infection and avoidance of sepsis. So just shortly about calprotectin in case you don't know so much about biomarker, it's a part of innate immunity. So all of us have this biomarker in our white blood cells from birth. And that's very important because it can be used, for example, then in neonates and newborns because it's already there, it doesn't need to be synthetized. It's not a new biomarker. It's discovered in early '80s by Magne Fagerhol and his research team at Oslo University Hospital. Calprotectin is released very fast, upon inflammation and infection from white blood cells. And it's one of the key players in inflammation and inflammatory response to infection. So, the awareness about calprotectin as a biomarker is growing since discovery in early '80s. And as you can see, there are 6,700 studies published, and this is -- the database called PubMed. And it's a strong increase in publication during the past 10 years. We at Gentian, we have focused on role of calprotectin around GCAL assay in infection. So we have so far published 14 studies in scientific journals. And we have shown and confirmed that calprotectin is really an early biomarker. We have done kinetic studies by injecting healthy people with bacteria or by endotoxins. And we have then measured kinetics of calprotectin and some other biomarkers. And we can see that calprotectin is detectable in the blood 1.5 to 2 hours after infection, or inflammatory response. And, if you compare that with CRP, which is well established biomarker, calprotectin is 12 to 24 hours earlier biomarker. And that's very important in case of severe infections and sepsis when every hour counts. So calprotectin can be used for early detection of infection. We have shown that using calprotectin, you can detect infection 24 hours before clinician actually discovered the disease infection and start to treat the patient. So 24 hours before symptom onset, calprotectin is increased, again, confirming the value of early. Calprotectin can also differentiate between bacterial and viral infection, which is very important because you want to know, if you should treat this patient with antibiotics or not. Moreover, calprotectin can tell you how sick you are, how severe you to your infection? Is it mild, moderate or very severe? Do you need to be transmitted to intensive care unit? Can you be treated in a ward, or can doctors send you home? And also to assess the risk. If calprotectin is very high, there is a high probability that the patient will die and/or end up with severe organ failure. So we have proven all of these statements here, in our publications. We have also done -- based on this early possibility to detect infection in an early stage, we have done a health economic model, showing that in patients that are severely ill and treated in an ICU unit, if you measure calprotectin and monitor these patients, and you detect infection 24 hours earlier, you can decrease length of stay in hospital and in the ICU. And we have shown in the model that you can decrease the length of stay at ICU by 2 days. They are most often treated at ICU up to 6 days. So, you can decrease this stay by 2 days, and up to 8 days in a general ward. So this leads to savings of up to EUR 14,000 per patient. So you can imagine big hospitals, small hospitals, crowded ICU units, lack of beds, lack of nurses, you need to prioritize who will be treated in ICU, and who will be sent to other kind of ward. So with calprotectin, you can save money. You can decrease mortality by 11%. You can use calprotectin for optimal use of resources, and you can also, of course, treat your patient in the most optimal way.

So Aleksandra talked about the benefits we have shown with the studies for severe infections. Now the potential for GCAL serum -- plasma calprotectin is actually across many different areas. We have proven really the first element. We have the first routine customers. We have shown the studies, right? But there's other areas where calprotectin by independent studies has been shown to be also beneficial. We have only touched the tip of the iceberg really with the potential with our own capabilities. But there is additional areas clinically extremely relevant, if you think about RA, if you think about Cystic Fibrosis, very important disease areas, which we have not touched yet. So there is further a lot of potential. And actually, Hilja, at the end will talk about -- or actually Njaal will talk about the market which we cover. So at the moment, we're only focusing at parts of the market potential with our current focus around GCAL. But there's other areas which can be explored further.

So we come back to importance of endorsement by key opinion leaders. So we have -- our clinical research program has raised attention within the different organizations and key opinion leaders. So we have a strong connection to International Sepsis Forum. That organization, which aim is to improve diagnosis and treatment of septic patients and the outcome of patients with sepsis. So we have dialogue with ISF, we have regular meetings, and we discuss GCAL, we discussed implementation in routine use, and we discuss research collaborations. So we have research collaborations with several people from the ISF Council, and some of the hospitals are also our routine users. Examples of hospitals who are endorsing and using calprotectin in clinical routine or Charite University Hospital in Berlin, University College of London, in London, APHP Hospital in Paris, Karolinska University Hospital in Stockholm, and there are many more. I will just show you the momentum which calprotectin is gaining. This is a picture from ECCMID, which was held in Copenhagen in April this year. ECCMID is one of the largest international meetings for clinical microbiologist and infectious disease specialists, with around 14,000 attendees. And here is Professor Evangelos Giamarellos-Bourboulis, one of the top key opinion -- global key opinion leaders, Chair of Sepsis Alliance, talking about role of calprotectin in organ dysfunction. So this is a proof that calprotectin is an interesting biomarker. And with our fully automated assay and fast turnaround times, there is a big potential for clinical use of the biomarker. This is another example from the same meeting. We have presentation from -- doctor from Charite Hospital in Berlin, [ Volcan Bauer ]. He is a principal investigator of a study that we have performed in collaboration with this hospital. So he has presented great results from the study during this meeting, and these results will be very soon published in a scientific journal. I will just summarized very shortly. This study has included 400 patients. They have seen great performance of calprotectin in detection of bacterial infections in patients coming to emergency department. So that they don't know, if they are infected or not. So calprotectin was able to detect bacterial infection in 92% of cases. Calprotectin performed better than other clinically used biomarkers that are more established in prediction of organ failure, prediction of sepsis, prediction of mortality. And, I would like just to prove what I have said about calprotectin being early biomarker, being good biomarker for detection of severe infection and for prognosis by presenting 2 patient cases. So, here is the first one. It's a Michael 56 years. He comes to emergency department, and he feels very, very weak. He has diabetes 1 -- type 1. His vital signs are normal. His blood pressure is normal. Heart rate is a bit increased, respiratory rate normal, temperature normal. They do examination, physical examination. They do a chest X-ray, they test his urine. Everything is normal. He has only a small wound on his leg, which seems to be healing. They measure routine biomarkers white blood cells, CRP, procalcitonin, routinely used biomarker for infection and sepsis. Procalcitonin is normal. White blood cells are normal. CRP is only slightly increased. That could be mild viral infection. Calprotectin is very high. So only calprotectin is increased, everything else is normal in this patient. This patient developed fever within 24 hours, and bacterial infection was confirmed in his blood. So again, 24 hours before everything else before clinical symptoms before other biomarkers being increased, which again confirms our previous results from previous studies. Another example, this is a man 85 years old. He is resident in a nursing home. He comes to emergency department with fever, altered mental status. He has late-stage Alzheimer's disease. His vital signs are -- some are normal. Heart rate is a little bit increased, respiratory rate a little bit increase and temperature increased. So they do -- again, they measure routine biomarkers. So white blood cells, CRP, PCT, they are slightly increased. PCT level of 1 is a sign of infection. Level of 10 is a sign of severe infection. So level of 1 could be a sign of, okay, there is probably a bacterial infection. Patients had a fever. Let's treat him with antibiotics, maybe send him to ward. Calprotectin is very high, even higher than the previous patient. This man develop a septic shock within 8 hours, and he dies within 48 hours. So with calprotectin being high, that is very early sign that this patient needs to be sent to highest level of care in order to save him to put them under respirator, on dialysis, whatever. So having calprotectin, again, earlier and higher mix diagnosis better and faster. So, we have shown in our studies that Yes. Actually, you can use GCAL assay, not only to detect infection, what we previously thought. You can use GCAL assay by area of clinical situations. You can use it to detect infection. Is this patient infected or not? Is it bacterial or viral infection? Should I treat with antibiotics or not? You can decide the level of care, does this patient have severe, moderate or mild infection, -- should I send this patient to ICU or should I send him home. And also for prognosis, is the risk that someone will die. If calprotectin is high, it could be a risk for clinical deterioration, organ failure and that. Or should this patients recover most likely. So, we are convinced that GCAL assay has a broad area of use, and great value and potential both for treatment of patients, but also for the health care system.

So in summary -- thank you, Aleksandra. In summary. The diagnostic industry and the clinical laboratory is a very slow-moving environment. Compared to Cystatin C that we have shown before, GCAL is not an established product, not an established biomarker yet. Cystatin C is well established. But think about the time it takes to establish even that sort of product. So this is -- this takes effort. This takes time. It takes conviction and it takes a lot of support from the scientific community. And so we have high expectations of GCAL. It's, as we've proven in those studies, highly relevant, showing clear benefits to treating patients that are severely ill, right? But, when we really look at the commercial side of GCAL, yes, you've seen 70% growth over the last 4 years. Yes, it's in the NOK 3 million area, right? It's not a big contributor, but it's growing, but the implementation, the adoption requires certain elements for a product like this. And what we have done, we have clinical studies absolutely relevant. You've seen some results, and that's only, again, a small glimpse of what has been achieved. We have clearly endorsement from KOLs. All the exchanges with the community like the ISF but also others, Charite, I think, is the largest hospital in Europe. It's a key institution in terms of patient treatment. That is key. APHP -- we also have commercial partners, Eurofins, one of the largest private labs in Europe also is using GCAL routinely. And yes, we have 2 major IVD partners on board. One of them we can name it Siemens Healthineers. They have implemented the product in 2022. And we're working with them on expanding the regional footprint of commercial execution. So we're totally convinced, this is the right way. Those are all the elements that you need to do to establish a new biomarker, and a new product like GCAL. But we're on the right track. And so we expect, we expect growth -- significant growth from GCAL. But it's another one of those reasons we follow science, right? It's adopted. It's clearly shown as being a great biomarker, which helps taking better treatment decisions. And that's why, we developed the product and not just because we can make the product. And therefore, I think we have great expectations of this product in the future. Good. So that ends our double conference. Aleksandra and we'll move it over to Njaal.

Thank you very much. Before I start, just a practical note to those following us on the live webcast, please feel free to post questions, as we go here, we will bring them up in the Q&A session. All right. Having said that, I will try to wrap up a lot of the good things that has been said so far and try to draw a path of where we believe that we can take this company over the next 5 years. So obviously, as you have all seen and heard today, we are all about bringing efficiency into the lab to take existing biomarkers and -- which runs on low throughput or a lot of hands-on time technologies into the central laboratory, where the processes are automated. That will, of course, bring efficiency and savings to the lab. It's also just to remind you that all our assets are open platform. So when we develop and put an assay on the market, it can be put on, let's say, most of the commercially available instruments out there. So we are not dependent on one single system provider. As you just heard, we are not only about taking inefficient technologies to the most efficient technology. We also have GCAL, which is a novel biomarker, which we work hard, and we believe we will succeed in bringing up to being a commercial success. So, if we look at the market potential, let's start with the market. The global IVD market is about $80 billion, and we sort of peel the onion, and we say that for all of the products that we had either established or are in market development or that we have in the pipeline, we see a segment of about $1.8 billion. And as you can see, the Established Products, we believe that the market now is about $220 million. You heard Markus say something about $100 million for Cystatin C, more or less the equivalent for fCAL turbo, and then we have some of the smaller markets like cCRP and fPELA making up the rest here. That market is -- that segment is expected to grow by 5% to 10% per year. Then we have GCAL. So our current focus is on infection. So it is a bacterial infection market. That market has a market size of about $440 million. And it's growing, let's say, by 7%. In addition, as you saw, there is the inflammation market, which is a group of different conditions, I would say, with, for instance, Rheumatoid arthritis, et cetera. That is also a big market, about NOK 250 million, and we are evaluating what kind of market share we should address there. And of course, NT-proBNP being the market with the highest addressable market of $900 million. So that is in itself a good argument for continuing to invest in the development of that marker. Although it has proven to be more difficult than we originally anticipated, but it's a substantial volume. The demographics also is in our favor. Aging population, of course, will require more diagnostics. So to look at the Established Products, first -- and also seeing the portfolio here of revenues. We are not a one-product company. We already have a portfolio. And we have two let's say, well-established markets, that is Cystatin C and its fCAL with 39% and 36% of our sales, respectively. Then we had these smaller markets, Canine CRP and fPELA, which has, let's say, shy of 15% of our sales. And GCAL is currently 3%. But this is the marker that we hope will come up to a significantly higher share of sales over the next, let's say, 5 years. We also have established partners for most of these products. We have spoken about Beckman Coulter for Cystatin C. They have been around since 2008, was it? [ IDEX ], a major player within veterinary diagnostics. They use our Canine CRP, and of course, the fCAL and fPELA, it's a corporation we have with BÜHLMANN, which is a leading [indiscernible] specialist in Europe and also has a good presence in the U.S. Looking at profitability. So as you all know, we are not yet profitable. But we believe that we are on track. And if you look at the cost and the cost mix from 5 years ago until now, you will see that we have seen a steady decline in cost in percent of revenue. If we look at the COGS, so the cost of goods sold, which includes raw material and direct labor and other costs related to the production of our markers, we see that, that has gone from 56% to 48%, and we have said that long-term target is 40%. So we are not too far away from there. But the big potential in terms of increasing profitability for us is scale. As you have seen, some of you have been here before, and you were perhaps a bit surprised when you came and saw this new facility. We had doubled the size of the plant. So the footprint here is now doubled. We have, for the moment, more than enough room. But hopefully, within 5 years, it will start to be congested here again. But we have -- and we have looked at this extensively. We have very good possibilities to utilize scale advantages in our production processes. So we believe that the OpEx of the non-COGS-related part will also continue to fall as a percentage of revenue, as we grow our revenue. We have also had some discussions with investors regarding how our revenue is generated. How much of the revenue is some -- is recurring or how much of the revenue is automatically coming in every quarter, et cetera. And we have made an estimate and we have said that about 78%, so that was last quarter, so you can say about 3/4 of our revenues are generated with long-term contracts. So these are contracts that have been in place for many years, and that has years till they lapse or will be renewed. Then, of course, being a growing company. We also have sales not generated by long-term contracts that are, for instance, new potential customers. They want to test the product. They want to, let's say, in the beginning, be a bit pragmatic before they eventually sign up, and we turn them into a long-term contract. So we believe that, let's say, a lot of the sales here will run, and we need to add on to that sales. So it's not that Markus and his team starts with, let's say, an empty book every quarter. And this is, I think, quite normal for B2B, business-to-business type sale. Last year, cash position, NOK 76 million. So cash wise, we are in a good shape. It can be seen in relation to a cash burn of about NOK 5 million in quarter 1. So we are approaching a level here, where we will turn the company into profitability and hopefully also into cash positive territory. Okay. So I have this table with the different segments and market shares and ambitions, et cetera. We have tried to send them up for you. Looking at the established products, we are growing with about, let's say, historically 25% annual growth. We have previously stated that we have a target of growing that part of the business, with more than 20% per year. So for the moment, we have delivered on that. And, if we just follow that trajectory upwards, we will be at around NOK 250 million to NOK 300 million in revenues on the Established Products alone in 2028. GCAL, which you've heard about is, let's say, it's in the beginning, but we have started the sales. We are pushing and we are very optimistic in terms of what that marker can deliver. Of course, the uncertainty here is much wider than for the Established Product, but we believe that we can bring this marker in the next 5 years into the range of NOK 100 million to NOK 300 million revenue. So then GCAL, if we are on NOK 300 million revenue on GCAL alone, that will be 50% of the total sales of the company. So this is a potential transformer of the company if it succeeds. But that NOK 100 million, it's also a good contributor to the business. Then we have the pipeline. And of course, in the pipeline, the most important marker is NT-proBNP. And we have put substantial resources on the development and the troubleshooting because as you all know, we have had some technical issues with NT-proBNP, but we are making steady progress on it. But still, it is too early to say something about timing, and when we could have a launch of the product. So conservatively, we have said that from pipeline, we can get everything between 0, which is very conservative to NOK 400 million. And if we add on the most optimistic here, you will see that it equates into our ambition of generating sales of NOK 1 billion as a long-term ambition. So finishing up here before we go to the Q&A, we believe that Gentian has a very attractive value proposition. We bring something to the market, and we can offer laboratories higher throughput, more efficiency, less hands on. And as Markus says, we have -- the industry has a problem with obtaining enough laboratory technicians. We are operating in the market with strong demand growth. We -- I mean, let's say, the market grows with 5% to 10%. We grow with 20% plus. So we are enjoying the market growth, and we double up by taking market share. We are a small player. So for us to take market share is, let's say, it's easier than, if you are a big, big player. Diversified revenue stream. As I said, we are not a single product company. For the moment, we have 2 strong products, and we have a few more niche products, and we are looking forward to see GCAL coming in, with higher revenue numbers going forward. And, if you go and look at our financials from, let's say, 2018 or '19 and to now, you will see that all these ratios, when it comes to cost as a percentage of revenue is coming in, and it's an early sign of profitability. Just a reminder, our EBITDA for the first quarter was minus NOK 0.5 million. So we are quite closer now. And of course, we are positioned for strong value creation going forward with GCAL with these existing products, with, obviously, a great plan for how to scale up this operation without incurring too much cost. Yes, we are quite optimistic about the future. I think I will leave it -- I will leave it at that. The next slide is the Q&A slide. And I think the way we will do, it is that we will invite up all of my colleagues here. And we will start with taking questions from the audience. And, if we get something from the chat, our associate Ola, over there, will interrupt and come in. So I think I will go even more to the right.

So who wants to start.

I guess, my name is [indiscernible]. I just -- do I need to touch something. My name is [indiscernible]. I am just to declare it, I used to be the Chairman of the Board previously in this company. I consider myself Chairman of Gentian's Fan Club just to say it. I'm very positive to this, but still I have my worries. And my main worry, because Gentian is an R&D machine, and I am really worried about the innovative strength of this R&D machine. I noticed that you have changed the goal from launching from one new product per year to a steady stream. But I have to ask the question. There hasn't been a significant commercial product launch since 2019. So, it's a huge difference between one per year and a steady stream of -- from what I hear, nobody can say anything about when NT-proBNP is going to be launched. Only thing I hear is that, after optimization, it's somewhere between 12 and 18 months before it can be launched. And this means is the steady stream one product for 5 years? Or what is the steady stream here?

Thank you very much. Yes, this is a very good question, obviously. And we invest significantly in R&D, and we are under control to address it first. Under control, as we took the decision to change our statement from one product per year to a steady stream for two different reasons. One was our decision to invest and to continue the investment and the work on NT-proBNP which takes significantly part of our 11 people -- 13 people we have seen on the screen from Torsten team. And we strongly believe standing here that this vision which [ Arlen ] had expressed with us during the last market capital update is a vision, which we share. And we believe, it is a good reason to continue and not to stop. We have good progress. We have a good and attractive market as we have all seen. And we -- it takes a lot of resources, one reason. The other reason is the recent changes in the regulatory environment. Before the launch of a product in Europe was 1 month paperwork and then you bring it to market with data you develop yourself. So this will be a big challenge for companies who are not able to do clinical studies, which you have seen, we are, I think, quite experienced with doing that because this is now required. But it requires as well now additional 9 to 12 months of time and that are all, if you add these 2 elements up, has changed our statement. We still have now 2 products in pipeline in addition to NT-proBNP, plus we have product ideas in the exploration phase, which will -- as soon as we have NT-proBNP in a later phase, we will continue to accelerate this again. From an innovative level, to start with your first statement, the development of NT-proBNP is the top of the top in the world. There is no company, and we know them all, who can bring such a sensitivity level in PTA technology, which confirms this is our focus, this is our area of expertise, and this is why, we will live again that we need to continue to bring such a product to market because we're pushing here the barriers. Next question. Next question.

Well, there was not -- I have to say it as it is. There was no number. I mean you systematically avoid metrics in your information, and even in your answers to what is the real goal. What -- how can we as fan club members or shareholders measure, if you are performing according to standard or not. But I'll leave it at that and go on to another worry of mine. And this is in addition to the innovative strength. There is also the intellectual property side. And I think that the intellectual property on GCAL is expiring, in a couple of years. And the saying is like this, first, you patent your innovations, but almost as good is to invent your patents. And I wonder, what are you actually doing to increase the intellectual property side on GCAL?

This is a question for Torsten, but I think he provided already to you a certain level of numbers. We have a team, which is very experienced in patent applications. In addition to this, we need to position as well, patent and what kind of commercial value a patent has. So there are advantages. You have competitive -- the competitive have a more different, difficult way of copying you. But we have -- in the majority of our company, in the position of our company, we have process patterns. We are not a biomarker inventor. We are not a treatment company with one molecule. So our patterns have been and will be in the future more process patterns. And that is not an easy field to protect your knowledge because others can somehow work around. Everything is public. And Torsten mentioned already the word of trade secret. There are reasons for us to not do a patent because we make too many secrets public, and keeps them better in the company, and we have measures and means to do so. So this is a constant choice between being public and protect, what we can protect and what we keep internally. And you want to have numbers. We have currently a handful of patents active, granted. And in the last years, now I need to turn myself to Torsten, we have increased the number of patent applications significantly because of the work in R&D on NT-proBNP and other programs.

If you want to know we roughly have 10 patent applications in the run.

[indiscernible] only asked about the GCAL. I saw the 11 number. And I think [indiscernible] is behind all of everyone.

No. These were numbers coming from Gentian, but also from the team members, who came in from external sites.

But on GCAL, please. What are you doing?

On GCAL, we are currently evaluating new ways for a patent application. But as Hilja mentioned, there's always a discussion between R&D, patent attorneys, business development, CSO, is it worth to do maybe better as a trade secret or maybe better as a publication to block someone. So...

That is mix we are following currently.