Welcome to this webcast by Gentian Diagnostics for the Fourth Quarter and the 2022 Full Year Results. My name is Njaal Kind. I'm CFO of Gentian Diagnostics, and next to me is Hilja Ibert, the CEO of the group. Good morning to you all. Good morning, Hilja. Good morning. Just a few practical notes on this webcast. We will, after the presentation, have a Q&A session, so please use the questions box available to you in this webcast to write questions into us, and we will do our best to moderate those questions after the presentation. With that, I leave the introduction and start of the presentation to Hilja, and then I will be back a little bit later with the financial review. Hilja. Thank you, Njaal. Yeah, good morning as well from my side. It's a pleasure being again here and presenting our Q4 results. Before we do so, I have just to learn how to do that. I would like to introduce you to the company, especially for the participants today who had not been in touch with Gentian before. Within the life science market, we are fully dedicated to the clinical diagnostics market. This is the part where the laboratories provide results to clinicians in order to take good treatment decision. Based on the needs we have learned from the market and the skills we have assembled in our company, we have given ourselves the mission to innovate diagnostic efficiency in order to help clinicians take better treatment decisions. I hope that throughout this presentation, you will get a better understanding of what is behind this mission statement. Before I continue, I have to excuse myself for my voice. I caught quite nasty cold. I'm sure I'm not the only one here today in the room, and I hope that you can still understand me well. We consider ourself being a growth company, and our growth plan is based on several items. Foremost, obviously, our products, seven of them, they address in total a $1.8 billion market. The product would not exist and would not be sold into the market without the team which we have in place, therefore, we consider this equally important to our growth plan as the products are. Our go-to-market model is based mainly on partnerships with distribution companies, here, obviously the ones who provide the instrument platforms to the laboratory. This is what we call the IVD companies, in vitro diagnostics. Based on this model, based on the products, and based on the team we have in place, we have a long-term ambition to achieve NOK 1 billion within the next four-six years, in addition as well, getting into the area of a 40% EBITDA margin. We are quite confident about this ambition as we have achieved in the years 2019-2022, an average of 28% of compound growth rate. With this, we believe that our growth plan works, and we are continuing this path. A few more details on these four items which I have introduced you to. We have our seven products. We build them up by disease group, but we are not really disease-focused. Our aim is to help laboratories to become more efficient and our clinicians to take better treatment decisions. This is what drives the decision which product we develop now and in the future. Therefore, we talk in the moment more about established products because these are the products which are in the market, used in routine use, they're in the medical records. While we have as well one product which is in market development, and therefore another category, because here we still need to work with key opinion leaders to inform the market about the benefits of such a biomarker. The third category is obviously the products which we are developing, and here is our number one priority, the NT-proBNP assay, and I would speak as well a little more in detail about that. From a value proposition is what I mentioned before, all these products which we have developed, which we have in sales or in product development, enable laboratories to significantly improve their efficiency. That is very important these days as the laboratories have more and more samples to process every day, while they do not have more resources automatically. They are looking into process optimization, higher productivity possibilities, and that is what we are contributing to. The other element is then that by bringing those biomarker to the high throughput instrument platforms, which is a source of the productivity gain, the results will be as well faster available to clinicians. The biomarkers which we have selected add as well significant clinical benefits by having results fast available as well to clinicians. I give you an example about Cystatin C, the first one on this list. We are talking about kidney disease. Using Cystatin C to monitor the development of the kidney health, you detect, or the clinician can detect much, much earlier that the kidney is not doing well, and can make respective decisions to change treatment much earlier, and with this avoiding that the kidney becomes severe in terms of failure. Of course causes then dialysis or even transplantation. We are speaking about really significant clinical benefits here. The other example, I mentioned it before, we have one product in product development, GCAL, it's the third product on this list. Calprotectin in serum or plasma. It is a marker which is discussed scientifically as an early detection of severe infection or as well inflammation. We had in the last year, several studies started. We had in the meantime, several publications, and that helped as well to gain traction in the market, to have routine users, and as well, most recently, especially in 2022, that we gained our first IVD partners as commercial partners. We announced it is in January 2022 with Siemens, and in Q4 2022, we had announced the partnership with another IVD player who doesn't want to be named. The highlights for fresh from the press is that we have another very important study just published by the Karolinska Institutet. This study was started quite a while ago. Many studies have been delayed because of Corona, but now we are seeing that it's picking up, and we are very pleased with the results. We have shared the results with you in the stock exchange release, believe that this is another support for us going forward with our commercial affairs. Having that said, we have as well later on the Q&A, we're gonna have Markus Jaquemar, our CCO, our Chief Commercial Officer with us. If you have questions, especially on the commercials side, feel free to post them. The third category, as I mentioned, NT-proBNP, I will have a few updates as well on that later on. Before I get to NT-proBNP, I think it's important to share with you the market data, they are fresh from the press, updated. We are working with Kalorama, well-recognized organization. These data are now from 2022. The serviceable market has increased slightly to $1.8 billion. The growth rates, et cetera, no significant change to what we had reported before. All in all, we are believing that we are acting with our current seven products in an attractive market and have a lot of room for our growth ambitions. What is new as well is here that besides the established products, which are Cystatin C, fCAL, and fPELA, we have with GCAL, made a differentiation between infection, severe infection, sepsis, and GCAL as inflammation marker, for example, rheumatoid arthritis, which is a sizable market as well, and that is currently under evaluation, especially with our partner, Siemens. As I mentioned before, an update on NT-proBNP, one of those products where we have high expectations as well, as we know from the market, that such a high throughput biomarker, which is asked in high volumes, would help laboratories significantly to improve their productivity. In addition, while we have developed that marker, we have learned a lot. It's amazing to see about the awareness of the nature of this molecule, which is impacted by a phenomenon which is called glycosylation. Sugar molecules are attached to parts of the NT-proBNP molecule. Very early on, we had the hypothesis based on the scientific data that the glycosylation has an impact on the established assays which are in the market by underestimating the amount of this molecule in the plasma or in the serum sample. This has been confirmed by most recent results we have achieved with a working prototype and believe that we have here as well an additional value to the market now or as we're going forward, that is what science will tell us. In addition to this, the good news is as well that we have no further technical challenges identified. We are all hands on deck to further optimize the product as we are approaching near sensitivity areas which nobody ever has achieved in PETIA. This requires more time than a standard assay in the normal ranges of sensitivity. We have reported as well in the past about as a reference method, which we needed to better understand how do we do with our assay, how do we compare to the assays in the market, which again had demonstrated to us the effect of this glycosylation and that we are detecting with our approach and our design, higher numbers. We still aim to publish and present as well more data on that. While we have as well now for higher testing volumes, developed a simpler and more efficient reference method/calibration method. With this method, we have developed a calibration strategy which aims to stick to what is the standard in the market but still allow to being able to detect the to highlight as well those patients which have an higher number than what the current assays are providing. As well, from a commercial point of view, we have started, I think as reported earlier, to speak selectively into the market with potential commercial partners, continue to have positive feedback, are very encouraged by this. That was a part about our products. I mentioned before the team. We have a unique team assembled here in Moss, but as well at our sites in Stockholm, in the U.S., and in China. We have a team which comes from the early days of the company with a unique experience in the PETIA technology, and we have experience from people we have attracted from other companies with the experience we needed to grow this company to the ambition which we have stated with you. In Q4, we announced the change in the organization for having promoted Aleksandra Havelka to CSO. With this, our co-founder, Erling Sundrehagen, taking over a new role in the company as consulting founder, focusing obviously, as he did before, significantly on the NT-proBNP development. We had mentioned as well before that we are our major go-to-market model is the partnership with those companies who provide the instrument platforms to the market. We believe that this strategy works well. We have now concluded 2022 with a total revenue of 112 million NOK, and with this, a compound growth rate of 27% between 2019 and 2022. We have that achieved with partners like Siemens, Beckman Coulter, and Roche, which are the top IVD companies in the world. We have in total more, some of them don't want to be named, maybe later. All in all, those partnerships are very fruitful and we believe we are able to achieve as well more in the future. With this, it's my pleasure now to hand over to Njaal to look a little bit into what we achieved in Q4 and as well as the total year. Thank you. Thank you, Hilja. I will give a rundown of the financial figures and some of the most significant changes that we have experienced during the quarter and the full year 2022. Today we report sales of NOK 27.9 million for the fourth quarter, and this is 28% up from last quarter. If we adjust last quarter, so the quarter for 2021. Sorry for that. If we adjust for currency tailwinds, the organic growth is 23%. That's a strong growth compared to the fourth quarter last year. Full year revenues also increased. Sales revenues increased to NOK 101.6 million for 2022, which is 21% organic growth compared to 2021. EBITDA for the quarter was -NOK 1.5 million, which is a strong improvement from -NOK 8.5 million in the corresponding quarter last year. Of other significant highlights, I would say we entered into four strategic partnerships or distribution contracts with major IVD players in 2022. The last one we announced, that was for GCAL, was entered into in the fourth quarter. For those of you who follow us, we have said that we have a target of entering into one strategic contract per year. This was clearly a very good year for that yardstick. If we look a little bit deeper into the sales numbers, let's start with the geographical split of the sales, where we see, first of all, a very positive growth in the U.S., where we have seen revenues increasing from $2.5 million last year to $6.5 million this year. That's almost a multiplier by three. In Europe, we also see strong growth, 29% for the full year compared to last year, while in Asia, we have actually seen a decline of 6%. This decline is due to, and solely due to, Cystatin C sales in China, where we have actually seen a reduction in demand. The explanation is disturbances and closures due to the COVID lockdowns that has lasted for quite a long time in China. We now see these lockdowns being opened up, relieved, and therefore we should expect to see the sales to China normalize during 2023. If we look at the product split, as you can see, China and Cystatin C, we still have growth for the full year, 40 million NOK, so it's our biggest product. Cystatin C versus 36 million NOK in 2021. While the really the growth driver in 2022 was fCAL turbo, where we have increased our sales by more than 30%. Other revenues, those are some of the smaller products like fPELA and cCRP, and we also have the third-party distribution business that we run out of Sweden, where we serve the Nordic market, or at least Norway, Sweden, Finland, with third-party products, so products that are not made by us. Also strong growth in 2022. Looking at the cost development. Hopefully the right slide is on the screen now. Yes. Cost development, quite stable. We in fact, we report an OpEx which is the same or similar to the OpEx that we reported in 2021 of NOK 72.3 million for the full year. Now, a few comments to that OpEx. In 2021, we had some one-offs, especially on the administration expenses as we commissioned a new ERP system. We then said that we expected administration costs to decline again in 2022, and I'm happy to report that that has been the case. When we look at sales and marketing expenses, the increase here is of course related to higher on the ground activity as a result of less restrictions due to COVID. We have a lot of the more conventional sales initiatives like big conferences and also visiting customers physically that has started again. A lot of these costs are related to travel and conferences and direct sales and marketing initiatives. R&D spend, I'd say quite stable, a bit down in 2022. Again, keep in mind that towards the end of 2021, we were in the phase of completing the SARS-CoV-2 antibody assay, which drove up R&D cost a bit. Just a summary, if we look also a bit on the balance sheet, our cash position is 81.6 million NOK, still a strong cash position. CapEx in the quarter was 1.1 million NOK. We expect significant reduction in cash flow in 2023 compared to 2022, and that is due to the fact that in 2022, we had a major project here in our production facility to double the size and to more than double the capacity that we have here. That resulted in higher than normal CapEx. I'm pleased to report that that project has been completed. We don't see any additional CapEx related to the plant here itself. There will be some new equipment here and there, but that is not something that will drive a significant increase in CapEx compared to what you have seen here in the fourth quarter. Still a strong equity ratio of 82%. Free cash flow of NOK -11.6 in the quarter. Free cash flow pro-positive pre-R&D, that is for the full year. We will see quarters where we don't achieve that. In general, if we were to, let's say, isolate R&D and all the projects that are not yet contributing to the top line, well, then our cost base would in fact be profitable or result in profitability. We are getting there step by step, and of course, with the strong growth above 20%. I think it's now the fifth consecutive year that we have growth rates, sales growth of about above 20%. We do not expect over time the cost to follow that, so profitability will come at a certain point. Summary and outlook. What we report today is the result of these four established products that we have in the market that continues to grow strongly, in fact, more than 20% annually. In addition, we also have GCAL, which I think we can speak about later during the Q&A. But the plan here is to still prove clinical relevance of GCAL. I think that with a number of studies out there and also the study that was released yesterday and other studies that we have in the pipeline, we start to build a strong base of evidence for clinical relevance for GCAL. Of course, the other major opportunity here is in the pipeline, and that is to bring NT-proBNP to the market. On the tail of that, we also have a pipeline, and our ambition is to bring, let's say, a steady stream of products to the market. I will get back to that. In the pipeline, we do have a few projects that we are working towards proof of concept. As I said, on the commercial side, we aim to secure one new contract with a major IVD player every year. We make no change to that ambition in 2023. Of course, with increasing revenues, we also think that margins will improve. We aim to, in the long run, have gross margins at 60% compared to currently around 50%. Once we have some of these high potential markers like GCAL and NT-proBNP contributing on the top line, we should see a long-term EBITDA margin of 40%. So that's the targets, these are more the long-term ambitions that we have. We look at the outlook for the next 12-18 months, what we are looking to do on the established products. That's Cystatin C, fCAL turbo, fPELA, and cCRP. We are targeting additional deals with both large IVD companies and also, let's say, medium-sized companies with maybe a strong regional market position or a strong product position in some niches. Of course, geographic expansion is also something that we look into. In this industry, you need regulatory approval if you go into new territories. For GCAL, as I said, we are looking into announcing even more studies than we have done. The studies that we have and the database of studies, which is now building on calprotectin and GCAL, is to a large extent confirming what we see. It will now be an exercise of turning those studies and all this clinical evidence into revenues. One of the levers that we are utilizing there is also then to seek endorsement of key opinion leaders. Those are the experts around the world on, for instance, sepsis and infections that GCAL is addressing. Of course, for GCAL, we are open for business. We are attempting, and we have an aim of securing more partnerships and also entering into new regions. For NT-proBNP, as Hilja mentioned, the aim here, over the coming year is to successfully optimize the assay, and it is to seek also here, endorsement and buy-in from key opinion leaders. As we mentioned in the report, there is already commercial interest for the assay. Of course, we will continue to work on building momentum up until launch. On the pipeline side, as I said, we have two markers that we work towards proof of concept for, and we will come back to those markers when proof of concept is announced. That is the way we announce. Of course, in before proof of concept, there is this exploration, very early phase, where we also have ideas and where we do exploratory work. I think that concludes the presentation, the prepared slides. I see that there are some questions coming in here. I'm starting to read them out now. Before this Q&A, I would like to introduce our Chief Commercial Officer, Markus Jaquemar, which will be able to assist me on the answers. I think let's start with a question here which goes into sales markets. It says, you have signed four agreements last year, but the sales growth is not increasing. The question is, what will it take to accelerate the growth rate? Yeah. First of all, an agreement itself does not automatically increase sales as of that moment. That means it means implementation, execution of a common plan. We do expect acceleration in 2023 and 2024 from those concluded agreements. First of all. Secondly, we, as Njaal mentioned, we aim to conclude additional agreements to further accelerate the growth. Yeah. Our partner model is the basis of our business, and we continue to focus on that. Okay. Thank you. I would also add that, as you, as you grow, 20% growth from, let's say NOK 100 million, is of course in monetary terms, it will give in absolute numbers, twice as much growth as if you have 20% from, let's say NOK 50 million. Another question here, let's try to find another commercial question. You have steady sales growth, but the results are still negative. Do you have sufficient cash to carry your current strategy? I think I can answer that. Yeah, we have NOK 80 million in cash, and with now sales increasing, costs more or less stabilized, we will see a reduction in the cash burn. We have previously stated that the current business plan is fully funded in the short term. For the next one or two years, I'm not worried about the cash position and as long as we continue the growth that we have planned, we should have sufficient cash, yes. Pipeline, there's little visibility on the pipeline. Can you share some details on the two markers in proof of concept? In fact, our policy is to not disclose a lot on pipeline projects, and that is due to the fact that we are in a very risky phase, and we do not want to, let's say, give too much detailed information about something that may not occur. To say, I think what we are looking at in terms of proof of concept when it comes to the markers is to continue the theme that we are on, which is infection, cardiac, kidney to a large extent, and infection goes also inflammation. That's what I can say about that. What I can promise is that we will come back with a lot more detailed information and elaborate information once proof of concept has been reached, because then we have a stronger degree of de-risking. I think while I read a few of the questions coming in here, one question for you, Markus. We announced yesterday the results of a study performed by the Karolinska Institutet, where they have used our GCAL assay. I think it may be difficult for, for some of our investors really to understand the importance of that study. Would you be able to qualify it and put it a little bit in context? I mean, they First of all, what is Karolinska's position out there? Secondly, what does it mean that we now have a study that concludes that we can in fact use GCAL as a differentiator in the diagnosis of sepsis? It's a very significant study that was published by Karolinska. Karolinska is a leading European institution, a global institution in terms of hospital treatment. The largest hospital in Sweden, obviously. The outcome of this study is very significant. It was based on 350 patients actually, which were submitted to the emergency department with signs of severe infection. What is very important is that at that point of time, a decision is taken. Am I taking those patients to even further treatment in the intensive care units? That means very intensive treatments and making sure that the survival rate is actually increased versus submitting them to general wards. That has been a big challenge in the past. There are existing biomarkers today that are used. At the same time, there's a multidisciplinary group of clinicians that study the patient and take that decision. What the study suggests and actually demonstrates is that using calprotectin, in this case for the study, gives a better indication which patient has to be moved to intensive care, thus improving essentially better treatment and higher survival rate, prediction of severe infection. GCAL provided better results than any other biomarker which was used in the study. That's very significant. Sepsis is a significant event, and there are 60 million deaths globally for associated with Sepsis today. Can you also say something about how are we using these studies and these clinical results to, let's say, try to convert them into, to sales revenue? Yes. We have intensive activities around conferences and congresses, where actually we present the outcomes together with key opinion leaders and actually study proponents, right, to demonstrate the clinical benefit. We discuss that with partners. We have, as you mentioned, global partners which introduce the positioning and how these can be transferred into clinical benefits on a global marketing level in a joint initiative. All right. Thank you. Very interesting. Very interesting. Another question regarding studies, actually, I see on the, on the screen here. It says there are more and more positive research around Cystatin C. We have also seen that, and the question is, are you expecting more sales for this marker or more partnerships? The answer is yes. I'm very happy about the question because Cystatin C has been in the market for, you know, 15, 16 years. It's now accelerating in terms of understanding the benefit of Cystatin C as a better marker for diagnosing chronic kidney disease. The initiative or the acceleration started in the U.S., where a guideline was introduced to use Cystatin C as an additional marker to diagnose patients with CKD. Interestingly, just a few days ago, a study was published in Europe, which also recommends the use of Cystatin C with a new algorithm to actually determine what's called the eGFR, so the glomerular filtration rate, which determines the health state of a kidney. Suggests to also use that, biomarker, Cystatin C, in conjunction with existing markers. Very interesting. The answer is yes, we're expecting more partnership and more sales in also additional regions outside the U.S. I think we have earlier had questions about, let's say, what is the growth potential of Cystatin C. It's an established marker. We have sold it for many years, and maybe the perception out there has been that this is a mature marker with maybe a limited growth potential. Any comments to that? Yes. Essentially, biomarkers such as Cystatin C, while they're innovative, they're not necessarily part of guidelines and reimbursement schedules. With increasing visibility of benefits, they're introduced into those schedules which means then that clearly accelerates the usage of these biomarkers, thus the market will grow. I agree it's an established marker. It's an established marker in very niche applications so far. That I'm very positive will change. Thank you. Another question on sales here. Good presentation. Thank you. Says the question, any details on U.S. sales going forward, new distribution agreement, tier one or also tier two customer focus? Very good question. We are very closely watching both tier one and tier two potential business partners. The tier one being really the big five diagnostic companies which are the known Roche and Abbott, Beckman Coulter, Siemens, and then also Quidel. We're also looking at the second-tier companies. Yes, I'm expecting additional collaborations in the U.S., expanding our sales in that region. Okay. Thank you. A direct question to you, Marcus. It says, how strong do you feel Gentian products are in terms of competitiveness versus the competition? First of all, we don't have me-too products. That means our products are differentiated. They have a very specific benefit. We don't compete for the low-margin, me-too kind of products in the clinical diagnostics market. Our competition is there. Competition all accelerates the market, I have to say. We are very well-positioned because we always aim for highest quality. Which is proven by external quality control, measures. I think we're very well-positioned. Thank you. Looking back here, a question on NT-proBNP. It says it's now 1.5 years since you informed the market about challenges in developing NT-proBNP. Far, you have shared very little about the progress or lack thereof. The question is, are you getting closer to a point where you can open the lid and share some details, and I think timeline, yes. Today, in today's report and presentation, we are giving a few more details about the development and what we are working on NT-proBNP. When it comes to the timeline, we strongly believe that when you provide a timeline, it should be something that we can commit to and that we have a plan towards. We are still in a phase where, let's say, the development of NT-proBNP is a little bit like you take two steps forward and you take one step back. You make improvements on one element of the development, which can result in a setback in something you had previously resolved. We are still working on items like stability, lot-to-lot variation. We today also speak about the calibration. To put up a timeline with that amount of uncertainty is really not something that we think would be helpful. What we have said is that once optimization, which is the most risky and difficult phase for this project, once that is completed, then we are looking at a 12 to 18 months remaining development time. I think there is a similar question just below that. It says, it looks now that you will not have a new marker on the market for several years. Has the change in strategy and full priority on the challenges of NT-proBNP been the right one? I think, honestly, I think the jury is still out on that. Having said that, NT-proBNP, the opportunity that we believe that this marker represents is so big that it makes more sense to try to continue the development of that marker into success rather than having closed down that project and started the development of the markers, which probably would have had a lower potential. I think so far we are still confident that we will be able to successfully develop NT-proBNP, and therefore it is right to continue. Having said that, it is a correct assessment that the development of NT-proBNP to a certain extent results in delays of the products because we have put now, let's say a lot of our R&D resources on the development of NT-proBNP. Let's see. Are there any other questions here? I think one question or let's say a comment here, we have touched upon earlier in earlier presentations, Markus, is the U.S. market. We have last year or 2021, we had $2.5 million local sales in the U.S. This year or in 2022, we had $6.5 million. It's of course, tremendous growth, but in absolute numbers, it is small. I mean, comparable in Europe and Asia, we have, let's say, $30 million-$40 million of revenues. Is there any reason why the U.S. shouldn't have at least the same sales in absolute numbers? First of all, the U.S. number represents our direct sales to the U.S. through partners. There's additional revenue which actually generated in the U.S. If you look at the big picture. Overall, the U.S. represents 40% of the global IVD market. Therefore, this is obviously the 800-pound gorilla where you want to go to. Regulatory perspective-wise, obviously, you have an FDA obstacle to overcome. Which we have for some products. Cystatin C being one of them which is one of the reasons for its success. We're aiming, obviously, our new products to also make accessible to the market. We're in the process of understanding the market dynamics in the U.S. because they're specific. They're not comparable to Europe. Yes, we have a big focus onto the US. Is there a big potential? Absolutely, yes. You cannot address it in a naive manner. You need to address market access boundaries and regulatory requirements, and that's what we're working on. Just the thing, Cesar, there we have the FDA 510(k) clearance. Yes. For fCAL and fPELA, that's also open to the U.S. market, right? fCAL turbo commercialized by partner BÜHLMANN is 510(k) approved, absolutely. That's why there are sales in the U.S. for fCAL turbo. fPELA is actually an FDA. It doesn't have a requirement for FDA approval. It's FDA exempt. Yeah. Obviously, we also sell cCRP, which is. cCRP is actually a nice, a nice marker which has had nice performance in 2022, in fact. Especially also in the U.S., where three of the top veterinary institutions are our customers for cCRP. Okay. Okay. I think we have gone through the list of questions here. I would like to thank all of you, all the participants, both behind the camera here for facilitating this webcast and also to the audience. I hope that you have had good answers to your questions. We will be back with the quarter one presentation in due time. If you have any other questions or if there is something you'd like to discuss with us, please feel free to contact us. Yeah, I think I'll leave it at that. Thank you very much for attending this webcast.