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. We also have a significant number of attendees on the live webcast. We are looking forward to present the company for you. Some practical information. We have about two 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. Hilja.
Thank you so much. Yeah, 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. 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 spend 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.
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. With this, let me introduce you to Gentian. We are dedicated to the healthcare market, and within this Healthcare market, there is a sub-segment which is called in vitro diagnostics, and that is the market where Clinical Laboratories are serving clinicians to take treatment decisions. We have identified as a company one preeminent need in this part of the market, which is efficiency gains, efficiency on a lab level, efficiency on the clinical level.
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. The objective of our day-to-days as well, to give you more understanding of what that is. I start today now with a 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 country in the world. We do that, in fact, for many, many on all continents already. Why is this so?
In vitro diagnostics, these are reagents, fluids which are used on instruments, automated instruments in most of the cases, in our case. Our reagents can be used on all kind of instruments which are already established in the laboratories. 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, etc., done. 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 a, I would say, call it, still a smaller company in the market, still being already on a peer-to-peer level, quite recognized. Our commercial footprint is limited by our means and that means as well you need in every country to speak some of the local language. I cannot go from Norway to serve China. I cannot go from Norway to serve India. 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.
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. Guess what? The menu, the reagents they offer is part of this competitive advantage or disadvantage. 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 here, located here, and you will see probably today many of them.
Speaking of we are a public company, as you all 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 Axis, starting the company as a co-founder with Erling Sundrehagen, who is here in the room and who is still supporting our efforts in the company. Keeping as well people who worked many, many years together with Erling, 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?
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 a Roche or an Abbott or a 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 signature in such a big company is not so easy to get. With the experience we brought to the company, that is one example which helped a lot to get more of these contracts signed, which are ultimately the basis for the growth now, but as well the growth in the future. I had spoken to many of you about my passion, which is the diagnostics market.
I'm a microbiologist myself. It is a market which is not so well known and well understood. We are all here in the room probably patients here and there, and you know what a clinician is doing. When they draw your blood, when they are asked to for other kinds of parts of your body, you don't know what happens with this. Most of these specimen or samples are going into a laboratory. 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. In that lab, there are symptoms you have expressed.
With this knowledge of symptoms or with this knowledge, I want to know that I'm pregnant or not pregnant. 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 results, with the final diagnosis. 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. You, on a general basis, have certain checkup procedures like colon cancer screening in order to avoid that you will get cancer finally. Finally, you use it as well to monitor the treatment. The diagnosis is happening thanks to our product as well with most likely better treatment.
You want to monitor, is the treatment really working? Is it fast enough? Do I have to add something? The results of ours, but as well other biomarkers, support clinicians to take a decision, good treatment or no, I need to adjust, fine-tune, or stop as well 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. The immunoassays is our space. This is our technology expertise, which started with Erling. There is a lot of protein and biochemistry knowledge you have to have. What happens in your body?
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. You will hear more about that in a minute. We have mastered, in the meantime, a technology within immunoassays, which is called PATIA, Particle-Enhanced Turbidimetric Immunoassay, which allows to do a very sophisticated test, which requires until today, for many biomarkers, sophisticated instrumentation with a lot of reagents, a lot of washing 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.
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 products, we have several products addressing different diseases, and this is not our number one decision-making when we look into 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. We have products which are in different phases in their maturity in the market. How well-recognized are they in Europe, in the U.S., in Asia, in Africa? Here we have the so-called established products, and you will hear that word more often.
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. We will speak very briefly about fPELA, but the majority of time we will spend today on Cystatin C and fCAL 'cause they are driving currently our growth, and we assume as well for the future. They are significant important for our growth strategy. We're gonna 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 this biomarker from serum and plasma is increasing, and you will hear more from Alexandra about that.
Obviously, we will give an update on NT-proBNP, which will be part of Torsten's presentation, on our of most important pipeline project. 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. 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. That is, It's okay with our ambition. We always want more.
I want always more, we are quite proud about that. 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 do those kind of long-term contracts. These are the cornerstones of our strategy, we are confident about our vision and our plan. Speaking about that will be my final slide before we get into the details, is our strategy is based on our established products, which I mentioned before. We believe that we achieve 20% or more on an annual basis with the established product, 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 translate it 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 products to add to our growth strategy, as well that is part of it. The commercial partners and 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. 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.
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 Roche and to the Abbott in this world and say, "Whoa, 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. Profitable growth means that we are looking for an EBITDA margin of 40% within a five to six year timeframe, right?
You all will speak about more about that. With this, I hope I made you a little bit more curious about what is really behind all of that nice ambitions. As I said, we, for a change, we start with the future and then getting to what is today. 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.
Yeah. Thank you. I take with me some water. Can you hear me? Yes. Okay. Yes. R&D. 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. My wife is Norwegian. I moved to Norway 20 years ago. My background is in chemistry from University of Hannover. Started at Amersham Health, which became GE Healthcare back in 2004, after 11 years, moved over to Thermo Fisher Scientific, business development. In GE, I was working in different roles within research and development, 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. Later, in Thermo Fisher, when I was working in business development, Gentian was my customer, right? Always a good connection to Gentian throughout the years. Today, I will talk a bit about the department. What does it actually mean, research and development? Usually, you just say it R&D, right? There are differences between these two parts. Moving over to the different phases within product development. In the end, of course, NT-proBNP, where are we and where are we going? 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. Eight people, I think it's eight, right, have also a PhD. 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. All together, the group has 11 patents. These can be Gentian Diagnostics patents, but also patents coming from their former 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 cooperation partner having a new, exciting biomarker. 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? If it's not working, okay, you fail, then you start again, and you start again, and you start again. This is a special mindset, in the research part, and not everybody has that. 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? Maybe we just make a publication to block others.
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 de-risked. 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 then 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, yeah, my colleagues from QA are 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. Quite a difference between research and development, and of course, we are serving different platforms. As Celia said, we are on the open platform strategy, meaning, we not just have Roche, we also have Abbott instruments. We have Siemens instruments. We have instruments from Mindray. If you're thinking about these companies, a lot of these companies have also their assays, but on their own machines, right? They are working on this assay on their own machines, but we are serving all the different machines.
We need to also to have people who are comfortable establishing our products on the machines, but also traveling maybe to customers who have maybe a more exotic machines, right, and set it up there. They pack their coffer or their suitcase, two weeks at the site, setting it up at late hours. Moving over to the approach of product development. You see again research, development, launch, and lifecycle. 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. Then we are handing it over to the development people, to the development part, and then you're going to the optimization phase.
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." More and more people from the operations department are coming in on the scale-up because you cannot just have it in a small glass. It needs to be also in bigger reactors thereafter. Then you move over to the verification phase. As I mentioned before, this change control from the QA department kicks in. You set the specification, you have the recipe, everything's 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, retrospective, 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. There's the labels need to be ready. Everything is tested from start to finish. Then, of course, you have the launch and the life cycle. You need to serve the customer for many years thereafter. Each phase has also its 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. You know 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? To test it very early, you need to probably some blood from diseased people. These are called leftover samples. Erling and I, we have visited quite a lot of hospitals, right? To talk to the physicians and get leftover samples.
You can do that through the Norwegian Health Research Act. Of course, it's always difficult. 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 these 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 timeline, I would say from the experience, 18 to 36 months for assay development, and then you see the different, yeah, chances of launch, meaning that you de-risk the project and the product development throughout these 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 slides, it's more or less the same, but a bit information about the different products, the products in development, the products on launch and 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 cooperation 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 two markers in proof of concept. Then, as you know, we have NT-proBNP in optimization, and then our six 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. Up to now, there are assays on the market, but they still are more on the lower throughput side. As you can see here, 700 samples per hour.
With a turbidimetric test, we can go up to 2,000 tests per hour. In addition, throughout the years, we learned that the NT-proBNP molecule is glycosylated. It has sugars at different areas of the molecule, and this creates differences in results on different platforms, on different tests available. With our test, we will enable an instrument harmonization throughout the different platforms and also standardization. There's already a strong commercial interest. It's not a new biomarker. It's very well known for over 20 years. We are not starting with something totally new, which is great. We are transferring it on a new technology. Marcos already put some money and it sent, make market investigations with very interesting and good results, and we already have some communications with selected global IVD customers. We are opening this up already a bit.
You know R&D, we are very conservative. Oh, it's not there, but okay, let's talk to people. It's 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 twenty-first of March this year that we got the first patent in the U.S.. 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 with a pending application against the European Patent Office, here we expect a granted patent roughly 2024, 2025.
In the U.S., for the second four, maybe also within 2024. For the U.S. one, it can be maintained with this until 2041, and for the European one, once we get it, until 2040. 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 good progress, and established a simpler and more effective calibration method. 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. 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, "Hmm, we have real clinical samples are already available." These are clinical samples from university hospitals where we also get the clinical information. It's not just the leftover samples. These are really available samples, and we are eager really to investigate the performance of the working prototype on these samples.
We are starting, and we are planning for this. In the end, once we are out of the optimization phase, we anticipate six to nine months throughout verification and validation, and then six to nine 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, you have the notified body. For us it's TÜV SÜD in Germany. You cannot be ensured how long it will take. That's why we anticipate here six to nine months. I think that was my last slide. Thank you very much for your attention. With this, I hand over to my colleagues, Alexandra and Markus. I take also my glass of water with me. Thank you.
Pleasure to welcome you here as well from the commercial side. I manage the commercial activities in Gentian, having been here three years now, and we'll dig deeper into the commercial aspects during the next couple of minutes, and also introducing Alexandra.
My name is Alexandra Havelka. I'm chief scientific officer. I joined Gentian in 2017. 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. 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 maybe a bit hands-on to understand what the products are that we sell. 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. We follow the science that we bring products to the market, which actually respond to a commercial and a patient and clinical need. We don't just make products because we can or because we have fun, but because there's a need in it.
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 talk more about that product because it really has great potential still, even though it was launched quite a few years ago. cCRP, launched 2012, fCAL turbo, GCAL. 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 three 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. Some historic sales, just to give you some real sales data here. We've divided into areas.
We've got, as Nerol mentioned and Hilja mentioned, we have two 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. What you see here, you look at the scale, we are in the 40 million NOK range of annual sales today, and we have compounded average growth rate of 20%. They are the largest product, but they also grow with 20%. They are obviously our bread in our commercial efforts. 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 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. We should not forget that we have a commercial organization in the Nordics, managed by Alexandra as well, which has driven sensational growth in the past. Those are the elements you see the growth rates, 70% for the smaller products, but we start from zero, right? Then up to 35% in Gentian AB in the Nordics. This kind of historically shows our success, and yeah, we have doubled our sales within the last 3 years, I think.
That in a difficult environment through to the pandemic. 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. 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. It's key. Global diagnostics companies, we've been able to achieve contracts, partnerships in the last few years, and we have still a few in 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. We have number of distributors in Korea, in Germany, in France, who already start to commercialize the product within local markets. They're very often specialized for this type of business, for this type of segment. Finally, we do definitely have direct business with healthcare 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. 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. We've been very successful in the last two 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.
The combination of those three pillars, yes, we have direct access to critical institutions that like our product, require our product, but give us feedback what to develop. At the other end, we have the large diagnostic companies who multiply the sales of our product. That's our 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. It's not only the number of staff, but it's also the qualification of staff. 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.
Healthcare costs are skyrocketing, we provide products which actually offer cost benefit. They're more productive, more samples in less time, and also 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, etc.. These are the drivers that we respond to with the product that we bring to the market. The three products that we focus on now is Gentian Cystatin C, which is really our legacy product. I said from the beginning, this is a really, this is a very promising product for the future, and I think we can prove that. Through our partnership with BÜHLMANN, we've got the fecal testing products.
Finally, the product which is kind of on the verge between market development and starting to be an established product is GCAL. Those are the three areas we'll be talk about in a little bit more detail. The first one is actually Cystatin C.
Yeah.
Alexandra.
What is Cystatin C? Cystatin C is 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 Cystatin C, and that's a biomarker called creatinine. Cystatin C has much higher value than creatinine, and it's gaining momentum in a clinical world and in the world of diagnostics. 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 a kidney failure are not aware that they have disease because it's symptom-free, you don't feel it until it's too late. 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, you cannot use creatinine in children who are growing and the body mass is changing. There is different between boys and girls when they reach teenage. You cannot use it in patients with malnutrition, elderly patient, anorectic patients, amputees. There is Cystatin 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 3 times higher incidence of kidney failure. It's very important to diagnose these people in the 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.
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.
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 product, if you think about it, achieved FDA 510(k). I mentioned again, the U.S. 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. 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.
We registered the product and not just that by the way, all our established products are IVDR certified in 2022. Just to give you a number, how many tests do we produce? 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. We achieved NOK 40 million sales in 2022. I think that gives a very nice traction commercially. 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 NOK 50 million, NOK 100 million revenues. They have to prioritize which products they develop. Some of those products may not reach that. 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. 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. In fact, I think what differentiates us as Gentian with the Cystatin C product, there's some other companies that have that. Roche has a Cystatin C, Siemens has a Cystatin C. We're dedicated and somehow Gentian is synonymous 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 Knüttel 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 is brand Gentian. We have a lot of recognition in the market for our product even though it is distributed through other partners. Highly engaged with subject matter experts around Cystatin C. We are highly active with association that want to push the product or are active in kidney disease management. Well, you hear more about that from Aleksandra as well.
Yeah, 40% of revenues as associated with Cystatin C, 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? Currently the market is around $100 million, which is in the IVD business, not huge but interesting. 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.
Yeah. 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. Here is a recommendation by American Society of Nephrology and National Kidney Foundation for increased use of Cystatin C in plasma and serum. As I mentioned before, many people they're 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 a kidney dysfunction. 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 very strong network with global key opinion leaders that are supporting use of Cystatin C. In this slide, you can see pictures of two webinars that we have organized. On the left side, you see webinar organized in collaboration with top key opinion leaders from United States, two of them are also our routine customers, where they discuss the value of Cystatin C compared to creatinine in the estimation of glomerular filtration rate or kidney function. 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. We have strong support, and we have very good network globally that talk for the value of Cystatin C in disease of kidney failure.
Thank you. We're convinced that Cystatin C will continue to be a very strong product with high growth, maybe even higher growth. 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 one dialysis per year per patient is in the area of $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.
The momentum we think is there, broad endorsement from the scientific community and adoption of the assay in routine lab environment, driven by recommendations. We are engaged with these institutions that support and drive those changes because also the way we are known and historically with the product. 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. That's why we're very positive about that. Good. How are we doing in timing? One more? Good.
Next product is fecal calprotectin test, fCAL turbo. Fecal calprotectin is used to diagnose inflammation in the bowel, inflammatory bowel disease. With this biomarker, you can reduce the need of colonoscopy, endoscopic examination of the colon. 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. You, if you include anesthesiologist in this team, the cost is very, very high, and we will talk about that little bit later. Markus, I think you should talk to this slide.
In summary, the product, fCAL turbo, it's an assay which was introduced 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. We are in a market environment of about 80-100, so similar to Cystatin C, by the way, right? $80 million-$100 million. The current segment share that BÜHLMANN enjoys with us together is about 15%-20%. What is going to drive the growth?
Here we have regional expansion, we have adoption and guidelines, we are also in the process, or 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 today with lab shortage, need for automation, etc.. That's one of the reasons why growth is going to continue. Last but not least, acquisition of global partners, like in this case, Roche, which is number one in the diagnostic industry. They don't have that product, but we have a long-term agreement for Roche to provide the product.
Yeah. Our assay is adopted to automation, and there are several competitors which has automated assay on the market. Our assay is the only assay on the market with full automation potential from sample collection and extraction to analysis. 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 the laboratory receive the tube, they can just put it on the instrument and measure calprotectin in stool. There are no hands-on on stool samples in the lab, and you can imagine how popular it is among our customers because it is not very appreciated task to extract stool samples all the day.
We have asked two of our customers from Sweden what do they think about our solution after implementation of this patient-performed extraction. You can see that one of the customers, when we asked what was the challenge with your previous routine, they say that extraction was time-consuming, and it required one technician or engineer to work with stool extraction the whole day. Today, with our solution, they have decreased that time from one day to two hours, so they can definitely recommend this solution.
The other customer that we asked, they say that, "Oh, 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, FHI Laboratory. We will now be provider of fecal calprotectin fCAL turbo and fPELA assay to FHI. FHI is one very big customer, so we are extremely happy to be able to serve that customer with our products. Yeah. Again, guidelines, recommendations, and adoption. Why are guidelines important? They are important because with the guideline, 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. The aim is to get the biomarker into the guidelines and recommendations. In Europe, fecal calprotectin is well-established, routinely used biomarker for inflammatory bowel disease. In the U.S., the process has been slower, but we are getting there. There are two big associations, American College of Gastroenterology and American Gastroenterological Association, which now recommends use of non-invasive biomarkers, including fecal calprotectin, which is actually the best biomarker compared to some others 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, it's even more expensive. The cost for fecal calprotectin assay is $25-$30. 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. The reason for that is fPELA is assay which is used to diagnose disease of the pancreas. Many patients with pancreatic exocrine insufficiency, they have the same symptoms like patients with inflammatory bowel disease. They have blood in the stool, they have diarrhea, they go to doctor take fCAL turbo and fPELA test to exclude pancreas disease and confirm or exclude inflammatory bowel disease. These two assays are often measured in the same patient.
We are taking a step forward in our aim to improve diagnostic efficiency. We have fCAL turbo, we have this collection tube, and then we add fPELA assay, which can be measured in the same tube. Patient doesn't need to take two stool samples. They don't need to perform two 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. I think, yeah, we are half through.
I think this is great time to have a break, right? For coffee, drinks, bio break, whatever. We have what?
10, 15 minutes.
10, 15 minutes.
Yep.
We'll continue with GCAL. A last word on fecal calprotectin. I don't 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. A solution 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. I think good reason that first has chosen this product. So we take a break and see you in another 10 or so.
Mm.
We heard you already had some questions in the break. Obviously, I hope your notebooks are full of questions also for the Q&A session. We still have a little bit more to talk about before we finish with the Q&A session. The next product which we're talking about is a product with a lot of potential, which is our GCAL product. Alexandra.
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. Calprotectin is a fast and accurate biomarker for detection of infection and inflammation and detection of severe infection and avoidance of sepsis. Just shortly about calprotectin, in case you don't know so much about the biomarker, it's a part of innate immunity. All of us have this biomarker in our white blood cells from birth. 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 synthesized. It's not a new biomarker. It's discovered in early 80s by Magne Fagerholm 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. 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. This is the data from a database called PubMed, and it's a strong increase in publication during past 10 years. We at Gentian, we have focused on role of calprotectin and our GCAL assay in infection. 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. We have then measured kinetics of calprotectin and some other biomarkers. We can see that calprotectin is detectable in the blood 1.5 to 2 hours after infection or inflammatory response. If you compare that with CRP, which is a well-established biomarker, calprotectin is a 12 to 24 hours earlier biomarker. That's very important in case of severe infections and sepsis when every hour counts. Calprotectin can be used for early detection of infection. We have shown that using calprotectin, you can detect infection 24 hours before clinician actually discover that this is infection and start to treat the patient. 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. Calprotectin can tell you how sick you are, how severe is 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 doctor send you home? Also to assess the risk. If Calprotectin is very high, there is high probability that the patient will die and or end up with severe organ failure. 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. We have shown in the model that you can decrease the length of stay at ICU by two days. They are most often, treated at ICU up to six days. You can decrease this stay by two days and up to eight days in a general ward. This leads to savings of up to EUR 14,000 per patient.
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. 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 a most optimal way.
Alexandra talked about the benefits we have shown with the studies for severe infections. 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? 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. 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. There is further a lot of potential, and actually, Hilja, at the end will talk about or, actually, Njaal, you will talk about the market which we cover.
At the moment, we're only focusing at parts of the market potential with our current focus around GCAL, there's other areas which can be explored further.
We come back to importance of endorsement by Key Opinion Leaders. Our clinical research program has raised attention within different organizations and Key Opinion Leaders. We have a strong connection to International Sepsis Forum. That's organization which aim is to improve diagnosis and treatment of septic patients and the outcome of patients with sepsis. We have dialogue with the ISF. We have regular meetings, and we discuss GCAL. We discuss implementation in routine use, and we discuss research collaborations. 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 are Charité University Hospital in Berlin, University College London in London, AP-HP 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 microbiologists and infectious disease specialists, with around 14,000 attendees. Here is Professor Evangelos Giamarellos-Bourboulis, one of the top global key opinion leaders, Chair of Sepsis Alliance, talking about role of calprotectin in organ dysfunction.
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 a presentation from doctor from Charité in Berlin, Wolfgang Bauer. He is principal investigator of a study that we have performed in collaboration with this hospital. 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 summarize them 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 they don't know if they are infected or not.
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. 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 two patient cases. Here is the first one. It's Michael, 56 years. He comes to emergency department, and he feels very, very weak. He has diabetes type 1. His vital signs are normal. His blood pressure is normal. Heart rate is a little 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. Only calprotectin is increased. Everything else is normal in this patient. This patient developed fever within 24 hours. Bacterial infection was confirmed in his blood. 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 disease. His vital signs. Some are normal.
Heart rate little bit increased, respiratory rate little bit increased, temperature increased. They measure routine biomarkers. White blood cells, CRP, PCT, they are slightly increased. PCT level of 1 is a sign of infection. Level of 10 is sign of severe infection. Level of 1 could be sign of, okay, there is probably bacterial infection. Patient has 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 developed septic shock within 8 hours, and he dies within 48 hours. 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 on the respirator, on dialysis, whatever.
Having calprotectin, again, earlier and higher makes diagnosis better and faster. We have shown in our studies that. Actually, you can use GCAL assay not only to detect infection, what we previously thought. You can use GCAL assay in a wide 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 has severe, moderate, or mild infection? Should I send this patient to ICU, or should I send him home? Also for prognosis, is there risk that someone will die? If calprotectin is high, it could be a risk for clinical deterioration, organ failure and death. Should this patient recover, most likely.
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 healthcare system.
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. Think about the time it takes to establish even that sort of product. This takes effort, this takes time, it takes conviction, and it takes a lot of support from the scientific community. 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? When we really look at the commercial side of GCAL, yes, you've seen 70% growth over the last four years. Yep, it's in the 3 million NOK area, right? It's not a big contributor, but it's growing.
The implementation, the adoption requires certain elements for a product like this. What we have done with 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. Charité is, I think it's the largest hospital in Europe. It's a key institution in terms of patient treatment. That is key. HPHP, we also have commercial partners. Eurofins, one of the largest private labs in Europe, also is using GCAL routinely. Yes, we have two major IVD partners on board. One of them we can name, it's Siemens Healthineers.
They have implemented the product in 2022, and we're working with them on expanding the regional footprint of commercial execution. 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. 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. I think we have great expectations of this product in the future. Good. That ends our double conference.
Yes.
Alexandra, 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 five years.
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, assays are open platform. 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. We are not dependent on one single, system, provider. 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. 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 have either established or are in market development or that we have in the pipeline, we see a segment of about $1.8 billion. 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.
We have some of the smaller markers like cCRP and fPELA making up the rest here. That market segment is expected to grow by 5%-10% per year. We have GCAL. Our current focus is on infection. It is bacterial infection market. That market has a market size of about $440 million. 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, etc..
That is also a big market, about $250 million, and we are evaluating what kind of market share we should address there. Of course, NT-proBNP being the marker with the highest addressable market of $900 million. That is, you know, 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. It's a substantial volume. The demographics also is in our favor. Aging population, of course, will require more diagnostics. 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, we have two, let's say, well-established markers, that is Cystatin C and its fCAL with 39% and 36% of our sales, respectively. We have these smaller markers, Canine CRP and fPELA, which has, let's say, shy of 15% of our sales. GCAL is currently 3%. This is the marker that we hope will come up to a significantly higher share of sale 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? IDEXX, a major player within veterinary diagnostics, they use our Canine CRP.
Of course, the fCAL and fPELA, it's a cooperation we have with BÜHLMANN, which is a leading fecal specialist in Europe, and also has a good presence in the U.S. Looking at profitability, as you all know, we are not yet profitable. We believe that we are on track. If you look at the cost and the cost mix, from five years ago until now, you will see that we have seen a steady decline in cost in % 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%.
We are not too far away from there. 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 have 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. We have, and we have looked at this extensively, we have very good possibilities to utilize scale advantages in our production processes. We believe that the OpEx, so the non COGS-related part, will also continue to fall as a % 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 some ask, is it recurring, or how much of the revenue is automatically coming in every quarter, etc.. We have made an estimate, and we have said that about 78, so that was last quarter, so you can say about three-quarters of our revenues are generated with long-term contracts. These are contracts that has been in place for many years and that has years to the elapse or will be renewed. 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. We believe that, let's say, a lot of the sales here will run, and we need to add on to that sales. It's not that Markus and his team starts with, let's say, an empty book every quarter. This is, I think quite normal for B2B, business-to-business type sale. Last cash position, NOK 76 million. 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 one.
We are approaching a level here where we will turn the company into profitability and hopefully also into cash positive territory. Okay. I have this table with the different segments and market shares and ambitions, etc.. We have tried to sum 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. For the moment, we have delivered on that. If we just follow that trajectory upwards, we will be at around NOK 250 million-NOK 300 million in revenues on the established products alone in 2028.
GCAL, which you 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. We believe that we can bring this marker in the next 5 years into the range of $100 million-$300 million revenue. GCAL, if we are on $300 million revenue on GCAL alone, that will be 50% of the total sales of the company. This is a potential transformer of the company if it succeeds. That $100 million, it's also a good contributor to the business.
We have the pipeline, of course, in the pipeline, the most important marker is NT-proBNP. 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. Still, it is too early to say something about timing and when we could have a launch of the product. Conservatively, we have said that from pipeline, we can get everything between 0, which is very conservative, to NOK 400 million. 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.
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. We can offer laboratories higher throughput, more efficiency, less hands-on. As market says, we have the industry has a problem with obtaining enough laboratory technicians. We are operating in a market with strong demand growth. I mean, the, let's say, the market grows with 5%-10%. We grow with 20%+. 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 player. Diversified revenue stream.
As I said, we are not a single product company. For the moment, we have two 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. If you go and look at our financials from, let's say, 2018 or 2019 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 1st quarter was NOK minus half a million. We are quite close here now.
Of course, we are positioned for strong value creation going forward with GCAL, with these existing products, with a, I would say, a great plan for how to scale up this operation without incurring too much cost. Yeah, we are quite optimistic about the future. I think I will leave it, I will leave it at that. The next slide there is the Q&A slide, and I think the way we will do it is that we will invite up all my colleagues here. We will start with taking questions from the audience. If we get something from the chat, our associate, Ole, over there will interrupt and come in.
I think I will go even, more to the, to the right. Thank you.
Thank you. Who wants to start?
I can start. My name is John Afseth, and I just
Just-
Do I need to touch something?
No, no.
Shall it touch me?
It works.
My name is John Afseth. 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. 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 one new product per year to a steady stream. I have to ask the question, there hasn't been a significant commercial product launch since 2019. 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. This means is the steady stream 1 product per 5 years, or what is the steady stream here?
Thank you very much. Yes, this is a very good question, obviously. 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. We strongly believe, standing here, that his vision, which Arling had expressed with us during the last market capital update, is a vision which we share. 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. 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 one month paperwork, and then you bring it to market with data you develop yourself. 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. It requires as well now additional 9-12 months of time. That are all, if you add these two elements up, has changed our statement. We still have now two products in pipeline in addition to NT-proBNP.
We have product ideas in the exploration phase, which, 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 PATIA technology, which confirms this is our focus, this is our area of expertise, and this is why we believe again that we need to continue to bring such a product to market because we're pushing here the barriers. 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. How can we as fan club members or shareholders measure if you are performing according to standard or not? I'll leave it at that and go on to another worry of mine. This is in addition to the innovative strength, there is also the intellectual property side. I think that the intellectual property on GCAL is expiring in a couple of years. You know, the saying is like this: First, you patent your innovations, but almost as good is to invent your patents.
I wonder what are you actually doing to increase the intellectual property side on GCAL?
This is a question for Torsten. 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. There are advantages. You have competitive. The competitors have a more different, difficult way of copying you. We have in the majority of our company, in the position of our company, we have process patents. We are not a biomarker inventor. We are not a treatment company with one molecule. Our patents have been and will be in the future more process patents. That is not an easy field to protect your knowledge because others can somehow work around. Everything is public.
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. This is a constant choice between being public and protect what we can protect and what we keep internally. You want to have numbers. We have currently a handful of patents active, granted. In the last years, now I need to turn myself to Torsten.
Mm-hmm.
We have increased the number of patent applications significantly because of the work in R&D on NT-proBNP and other programs.
Right now, we roughly have 10 patent applications in the run.
I only asked about GCAL.
Mm.
I saw the 11 number, and I think Aline is behind all of every one of them.
No. These were numbers coming from Gentian, but also from the team members who came in from external sites.
Good.
Yep.
On GCAL, please, what are you doing?
On GCAL, we are currently evaluating new ways for a patent application.
Yes.
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 as better as a publication to block someone.
That is a mix we are following currently.
Jörn, we are very sensitive to it. You can be assured you have seen our optimism and therefore we I think we're taking the right measures to make sure that also in the future we have a well-differentiated product on the market.
Absolutely.
If I may one to the commercial team.
Sure.
I'll rest my case. I promise.
You're well done.
Okay. When it comes to GCAL, which is in my opinion, a wonderful product, and you have done such a good work on the clinical side to document it. Give me an indication of what is the realistic markup in price for GCAL compared to CRP? I think you're selling GCAL at the moment at the price of gold and this market, mass market, is not at the price of gold. CRP has an ex-lab cost of EUR 0.30 per test or something like that.
Yes.
How much markup do you think is realistic for GCAL?
Yeah, I can take that.
Yeah.
I can take that. I mean, we position GCAL. We had a lot of discussion on how we position the product. When we look at certainly the severe infections market, which is the one we're addressing at the moment, we have some, let's say, established products like PCT, and we position the product slightly below that. Very clearly reasons why, right? We have our value proposition faster, more efficient, productive, but also the cost benefits. Yes, it is a higher value market. I totally agree with you. I think the added value compared to CRP, which is just a super generic marker, right, is accepted. Did we have any issues in terms of adoption boundaries or obstacles?
As soon as we have a customer who understands the value of the product, we have not had any commercial discussion about that the product is too expensive, our experience. Can you long term, when you look at the market expansion, look at how you position the product also from a pricing perspective? We will. We might do some price elasticity studies, etc., to see would we benefit from larger adoption for different price point. I think personally that's too early right now. It's a good question.
Yeah.
Your pricing is PCT minus.
Yes. Correct.
PCT is mainly only a German market.
No.
Oh, yeah. You want to discuss more?
No. I rest my case.
Yeah.
Yeah.
I can just add to that because we have converted some customers from ELISA.
Yes
T o GCAL, and then the price is not an issue because they save so much time and work converting from manual method to fully automated. Of course-
Mm
T hat's not a big issue then, the price that we offer.
I think one important element is to understand the pool of money is limited. There, there is no increase of more money because it has a new biomarker. We all compete with other biomarkers. The first thing we did to your question, Jörn, is will CRP be replaced because of all the added values we have seen with GCal?
The answer was crystal clear from the market research, no.
No.
It's too long, too established. People know during the night you can call them, CRP is this, and they know what to do. CRP will not be replaced. When you understand that, because that would have been maybe a strategy. If you understand that, you know you have to compete now in the pool with other biomarkers.
Yeah.
That is, for example, PRC, PCT. This is as well white blood cells, as you have seen before.
IL-6.
IL-6. There are several biomarkers, and that is where we positioned our pricing, so it was based on facts.
All right. More questions. Do we have something from the chat? No.
Suzanne.
Suzanne has a question there.
Yeah. I just had a question for Alexandra about GCAL as well. because, I mean, it has huge, huge potential obviously, and now it's mostly done in a severe sepsis setting. Then you have a whole list of other indications as well, which are more like chronic conditions. How do you distinguish those two if you get a patient, for example, with a chronic condition and then wanna test them for severe sepsis? Are they different levels or like how do you do that?
Yeah. That's a very good question because calprotectin, if you have a patient with IBD, untreated IBD or rheumatoid arthritis, of course calprotectin will be increased. The doctor needs to have complete information about other diseases that the patient has. If the disease is treated, we don't expect high levels of calprotectin, you can in a better way differentiate between infection and chronic inflammation. That's something that doctor needs to address if the disease is untreated.
Just a follow-up question to that.
Mm-hmm.
If that disease then is treated with, example, anti-TNF-alpha or whatever, do you then also expect a worse response or like a more... less specific response to GCAL in a severe sepsis setting, or is that not the case?
Yeah. There are studies on IL-6 inhibitor, tocilizumab, which does not affect calprotectin value-
Right
It affects IL-6 value, and CRP, which is induced by IL-6. For tocilizumab, there are studies published that this treatment does not affect calprotectin value. For TNF-alpha and adalimumab, it's not crystal clear. There are studies supporting, there are studies in RA showing that calprotectin can be used for treatment of this, of the monitoring, the values will go down if patient is treated with these drugs.
Thank you.
In fact, Siemens, our partner with GCAL on the nephelometric platforms, is positioning, has launched GCAL together with TNF-alpha inhibitor at the same time to address the market, which is largely RA.
Mm-hmm.
Yeah.
Great.
Other questions? It's your last chance. Yes.
I'm Adil from the Delphi Funds. Thank you very much for a very good presentation. For a pure economist like me, it's always good to get a better understanding of the company, so thank you for that. On proBNP, just to get an understanding, kind of the risk here, you have a range where you kind of state 0-$400 million. And also there's potentially some time before the kind of the market opens up. How should we think about the risk? Is this kind of a 50/50% chance that this product is successful? Is there a different split? And my second question is maybe for you, Noel, on the different indications.
You state a target market share, which is quite specific, while the revenue targets are ranges, are the upper end of the ranges if you hit that market share, just to get a better understanding of those?
Yes
T hose ranges.
Yeah. I can answer that right away. If you take the table with the market shares and the revenue take, if you add up all that, you will get to approximately $1 billion.
50-60.
Let's say the ranges are there also to give some flavor that, let's say, there are other scenarios than the blue sky scenario, obviously. NT-proBNP, I don't think I should answer that.
You may remember a slide from Torsten on the different development phases. With all the experience we have assembled in this company, we have quite early onset. Can we, because we know we receive these questions, assess the risk if this product will make it to market? In fact, the product will most likely always work in diagnostic, but is it fulfilling all the specifications? For NT-proBNP, for example, is it sensitive enough? Does it measure low enough to make sense for that kind of application that it is meant for? With this risk assessment, we have put this 0% to 50% to 70% to 100%. 100% is obviously after the launch.
In the optimization phase in which we are today, at the beginning of the optimization phase, the risk of not making it to market successfully, at least not in the specs as we have planned, is 50%. By the end of this phase, we will have approached 70%.
Mm-hmm.
Torsten was just about to say we are better than 50. We are not yet with 70, otherwise we would let you know. We are reviewing the, this, not the risk, but where we are with our solution-finding process on the technical challenges. We are reviewing that not only internally, we are reviewing that on a regular basis with internal experts, our board, and we have expertise on the board, and as well as scientific advisory board. Therefore, our belief that this is a good assessment is quite strong and I think that is probably what we can tell you best. The 0 to 400, you all maybe you can make a point on that as you said, it's ultra-conservative to go from 0.
Yes, I think well, if we say that we are not able to generate anything, any revenues from the pipeline, that's obviously then you have zero revenues. We consider that to be on the less realistic side. This was an exercise to try to say what areas are we quite certain about the revenue development and which areas are more uncertain in terms of revenue development. Of course, with NT-proBNP, we have its technical risk. If we don't manage to solve those technical risks, well, then it doesn't matter how much commercial interest you have for the marker. Having said that, we have strong commercial interest for the marker.
It's a major market that we address there, so we will continue to invest in the development of NT-proBNP with the aim of launching it as a successful product.
Mm-hmm.
Could you maybe just add some flavor on the commercial risk for NT-proBNP if you make it to launch versus, for example, GCAL?
Yeah. I can.
Be my guest.
The difference to GCAL is that GCAL is a product where the market needed to be developed. NT-proBNP is an established market today. We plan to bring it to the market in a different format, which provides all the benefits that we talked about, right. There is the adoption of the product, right, is not related to questions about the biomarker. It is really commercial execution and partnership. The good news is we have market pull for the product already, which means high likelihood of commercial increase as soon as the product is available. That means the market development efforts are much less than for GCAL. From that side, I think there will be more focus on developing partners, right.
Mm-hmm
than explain the market what the product can do. Everybody knows NT-proBNP. It's within the cardiac marker business, which total is maybe $2 billion, right? It's the one that has the most traction. It's a relatively young biomarker, right? It enjoys nice growth. We don't need to explain that, fortunately.
Having said that would be the first phase. The second phase, we have now developed to our innovative level, a biomarker which is calculating or measuring the true value of NT-proBNP in your blood. This true value is now discussed more and more scientifically. Other markers, they detect the molecule on the wrong part, and they can never detect the true value. Our assay is a first as a PETIA assay, and I think there are only two in the market currently in total, who detect in the neutral phase the true value. There will be a market development towards true value.
Yes.
The values are much too dependent of if there's glycosylation or not. Very technical. That would be the phase 2 of developing a market. That will not be done by us alone.
No.
That for sure. We are working here as well with other partners and as well here in this case, competitors help as well.
Mm-hmm.
Mm.
Okay. Andreas.
One question about the partnering agreements. You managed to sign several agreements last year. Of course, we will see that in the numbers for this year and the coming years. What are you aiming for in 2023 regarding new distribution agreements?
What are we aiming? We're aiming for as many as we can. I mean, we always, I mean, do that. I would say what is a significant difference is that we have proven to partners, to large diagnostic companies, our capabilities. I think that puts us into a different ball game with discussing potential partnerships. Now, we have mentioned we cannot publicly announce all of the partnerships that we do have. I would say there are several in the pipeline, new ones, right? For 2023.
Maybe just
And-
Online participants, I need to speak into the microphone.
And-
Just to add, our strategic.
Yeah
Ambition is at least one-
One per year.
P er year. This is at least what we have. That requires that we have several negotiations ongoing. Several.
Yeah.
It takes long, as I mentioned. This is very complicated organizations. Till signature it can take years.
There's also, I mean, you have your top-tier IVD partners. It's the usual ones. It's Roche, it's Abbott, it's Beckman Coulter, it's Siemens, and to a certain extent, QuidelOrtho. That's the creme de la creme. There's an interesting segment which is the second-tier companies. They are more focused on certain segments of the IVD business and depending on the marker. We're also looking at those because the process for engaging and obtaining agreements is actually typically shorter than with the big boys. That's why we have a slightly different strategy for that, but we're working on both.
Next question. Okay.
Online? No.
No online. Okay. I think it's time for us to wrap up here. For those here in the audience, we are offering a facility tour directly after this. For those of you who have attended on through the webcast, thank you for your participation.
Thank you.