Good morning and welcome to this webcast of the Gentian Diagnostics Q3 results. My name is Njaal Kind. I'm the CFO, and with me today I also have Hilja Ibert that will start her part of the presentation shortly. Before we get going, I just want to make you aware that you have a questions box on the right side of your screen. Please submit your questions during the presentation, and we will try to address as many of them as possible in the Q&A session that will commence after the presentation. With that, I will leave the work to Hilja that will go through the first few slides of the presentation. Hilja. Thanks. Thank you. Good morning, everybody. Yeah, this morning you see a quite happy CEO, and I hope at the end of this presentation you will better understand why. I would like to kick off the session this morning by introducing you to the company before we get to the financials. I need a little bit of help from Njaal to move to slides, please. Thank you very much. Yeah. For those participants this morning who had not heard anything about Gentian Diagnostics before, we are a company acting in the healthcare market, but being fully focused to the clinical diagnostics segment within this market. That is the part where treatment is not happening. In fact, it is the step before helping treating physicians to diagnose a disease. In this case, our products, which are reagents, are not facing a patient. They are facing the samples of a patient, which could be blood, which could be serum and plasma, wound swabs. Many different parts of a body which are examined in laboratories. The laboratories are the end users of our products. We are a technology innovator, and we are fully focused on one of the major needs in this market, which is efficiency. Gain of efficiency on both sides, the laboratory efficiency, but as well the clinical efficiency. The overarching goal is obviously to support clinicians by doing so to take better treatment decisions. A little bit of an explanation before we go even more into the details of our growth ambition and our growth plan is that, our products are reagents. Reagents which are used on clinical analyzers, which are provided by many other companies in this market, and major IVD companies are often found in those laboratories. They don't have all menu items or biomarkers on their instrument platforms, and this is where we are coming in adding value by adding biomarkers which are relevant to such kind of menu. The most important element in terms of efficiency is here as well, that we enable the laboratories to shift those biomarkers from lower productivity, lower efficiency, efficient platforms to be shifted to the highest throughput and therefore as well the highest laboratory analyzers from a productivity point of view. That is the element which drives value for the laboratories to use our biomarkers. By doing so, the laboratories have a value opportunity to provide now results from those relevant biomarkers to clinicians faster. That is a part of the efficiency gain using these highly automated instrument platforms. Having results faster and having now biomarker results which have clinical value in addition to this enables clinicians to take treatment decisions now based on information which are very important and relevant for the diagnosis of certain disease. This is in a very high-level an explanation of our core value proposition. A high summary of our growth plan is that we have the ambition within the next six years to grow the business to NOK 1 billion. This ambition is based on seven products which we have in the market or in market development or in product development. I will speak in a minute more about that. But it is equally important as well, and the ambition is as well equally based on the team which we have assembled during the years, I should say, since the company has been started. We have assembled a team of know-how with know-how which is unique but very important as well for this market. I will speak as well in a minute about that. We are confident about our ambition because when we are looking back, we have achieved 27% growth between the years 2018 and 2021. I mentioned that I would speak a little bit more about these individual items I had mentioned before. Starting with the team. We have a management team which represents quite nicely the entire employees of the company. Diverse and have been successful in supporting Gentian with the start and being already many, many years with the company, or having helped other companies to be successful and having joined Gentian more or less recently. All together, we have a deep understanding of our technology, and we have a deep understanding of the needs of our end users, the laboratories, but as well our commercial partners, the ones who are selling our products, especially as they have instrument platforms and adding that to their menu. They treat our product as if they are their own developed products. Speaking about the products, seven are part of our current growth plan. As you can see on the left side of this slide, we are addressing different kind of disease areas. Our focus is not one disease area. Our focus is those biomarkers who drive efficiency on a laboratory and on a clinical level. The laboratory efficiency is driven by all of these seven on this list. The clinical benefit is very individual and very different, and I would like to give you a few examples. Cystatin C is the first product on this list. It's a protein which is addressing the kidney disease segment of this market, and it is a biomarker which detects kidney failure, kidney function reduction earlier than alternative markers in the market. Being now able to have this Cystatin C result fast provided to the clinicians is supporting the clinicians to take action on reduced kidney function, with this avoiding severe kidney failure and with this, morbidity, mortality, and of course, significant cost to the entire healthcare system. Another example is, the next product on this list, which is addressing the inflammation infection market, is called fCAL. Here in this case, we detect a protein in stool and not in blood samples like the Cystatin C. The added value of fCAL is that, physicians often are faced with patients who have unclear symptoms in the bowel. Very often, to be safe, they are sending those patients to the colonoscopy to better understand if there is anything wrong in the gut. It's uncomfortable, and it's a highly costly examination. In many countries of this world, it is limited, so there are long queues. In order to help physicians to have a better triage, which patients really need this examination and which patients don't need it's not severe, a normal diet can help here. This result of fCAL helps physicians significantly, and that is as well demonstrated by the growth we have seen with this biomarker since the last years. Cystatin C and fCAL are examples of our category established products. We have as well Canine CRP in this category, and we have as well the last one on this list, fPELA, in this category, just for your information, as I will speak later on about established products. We have as the next product on this list, GCAL. GCAL is a product where we had as well one of the good news today and one of the reasons why I am very happy today. I will speak a little bit more in detail about that. GCAL is an example of a product which is in market development. As I mentioned, I will speak in a minute more about it. SARS-CoV-2 antibody is another example of a product which is in market development, but a market development which we will not drive ourselves. It is a development which we have to follow based on key opinion leader and respective governmental decisions to take on that opportunity to measure the immune status of patients or not. This is what we always said from the beginning. We offer a tool, and I hope that it's taken by governmental decision-makers. Last but definitely not least on this list is NT-proBNP, which belongs to the disease area cardiac. NT-proBNP is in product development. We have communicated a lot in the last quarters about it, and I will therefore as well continue with this and will have a dedicated slide about that. About GCAL. We have started market development efforts for GCAL several years ago in Sweden and the last three years we had rolled this further out as well in other European countries. Our focus was Europe and is Europe. This is as well important for small company to be focused. GCAL is a biomarker which detects early inflammation or infections within patients. It is described scientifically as being earlier than alternative biomarkers. This scientific discussion description had been supported as part of our market development in the last years by studies which we have as well started and our collaboration with key opinion leaders. As an outcome of these efforts, we are very proud and happy to have announced another distribution agreement with a major diagnostic company. Yesterday night, in fact, we announced it or this night, and we just announced it this morning and believe that with this additional distribution agreement with a major diagnostic company, we have now a good basis to continue to go to the next level of market development with supported by very well-trusted and strong partners on the market. I mentioned a second. Earlier this year, we had announced the collaboration with distribution with Siemens Healthineers. As Siemens will concentrate to start with on the inflammation part of the market, while our new major partner is addressing the entire opportunities of this biomarker inflammation, but as well our efforts in the field of infection and respectively avoiding severe infections which ultimately can lead to sepsis. Yeah. This is the beginning of a journey of acceleration of commercial efforts. We have focused in the last year for market development. We see now the early results. We continue market development, but we have now much stronger means to have a commercial effort, and the roll-out of the new partner is planned for early first half of 2023. NT-proBNP, our product in product development is progressing well. NT-proBNP is a well-established biomarker, high demand for this product, as it supports clinician to identify congestive heart failure as early as possible so that respective treatment can start. It's a high-volume marker, and shifting such a biomarker then to the highest possible automated and productive instrument platforms is obviously appreciated by the market. In addition to this, we aim as well to support this market with standardization of results, which is an issue. It's a confirmed issue in this market. We had last year reported certain tech challenges which had resulted in a delay of the product development, I believe not really so uncommon, I'm since 30 years working in this market. Yes, if you are working on breakthrough innovation, there are as well delays to be expected. Since the beginning of this year, we have been able to report progress made and as well for this quarter. I'm very happy to report that we have made further progress with our new immunoparticle lead candidate. We have been able to develop a working prototype. Further robustness testing are required before the optimization of the product and final product design is accomplished, but so far, so good news. With these seven products, how have we come to our ambition? That is based on bottom-up indications we have from our partners and as well end users, and top-down as well, obviously, from market data which we had acquired from Kalorama covering 2020. As we speak, we are updating this data. COVID-19 had a significant effect on the market, and it was not helpful during the last years to update anything as it's a big flux. It's now the right moment to understand what are the new estimations and expectations for the future for the categories we have established. I mentioned before the so-called established products, and we have differentiated between the total addressable market and the serviceable market. Let's focus on the serviceable market, and that is the market which we concretely address with our biomarkers. For the established product, that is the market of $180 million. GCAL alone is addressing with understanding of 2020, a market of $300 million. NT-proBNP, $800 million. I mentioned it's a high volume product. SARS-CoV-2, we focus currently only on the Nordics market. Therefore, we are very modest with our assumptions on the serviceable market. All in all, we are getting to $1.3 billion serviceable market as our target market. We strongly believe that we have the opportunity together with our partners, to achieve market shares between 15%-25%, depending on the category and the respective competitiveness in this, in these categories. As Gentian is selling mainly via commercial partners, we take from that share 30%-50%, depending on the contracts we have in place. All in all, the market growth was in 2020 estimated to be 8%-9%. Let's see if this continue, but overall, it's a nicely growing market. With this, that's all, we have an opportunity to bring our company within the next four to six years to $1 billion. Why are we confident? I mentioned it already before. During the last years, we have been able to grow our business by 27% on average, and we have been able as well to grow our commercial footprint with partners like Siemens for GCAL, as I just mentioned before, Beckman Coulter for Cystatin C, and Roche for fCAL via our partner, Bühlmann in Switzerland. More contracts have been established this year as we had announced them, but they had been with partners which do not want to be named in public yet by us, and that is a well-known common practice, so nothing special about that. With this, I hand over to Njaal to speak a little bit more about what happened in Q3. Thank you, Hilja. So I'm gonna give a rundown of the figures that we disclosed in our quarterly report this morning. Pleased to announce that sales are up by 34% compared to the Q3 last year, and coming in at NOK 23.1 million. The Q3 for us is normally a seasonally weak quarter due to the summer holidays in Europe, where the outpatient market is going down. Compared to last year, quite strong growth. We have over time, for some time now invested in the US market with feet on the ground and also market activity. We now see a quarter again with very strong growth, although from a low base, but progress is being made there. We also, Hilja spoke about, distribution agreement for GCAL. We have also concluded a distribution agreement for Cystatin C, and we expect to see sales from that distribution agreement from next year. Another big milestone for us is of course the IVDR certification. Our regulatory affairs department has worked hard to achieve this certification, which will become a requirement over time. This is basically our license to operate, so we are obviously very satisfied that we have achieved this IVDR certification quite quickly, which proves that our regulatory affairs department has done a good job on this project. Also, as Hilja mentioned, we are making progress on NT-proBNP with now a working prototype. Further optimization will continue, and we will update the market accordingly when progress is being made. As mentioned, GCAL, we have already an agreement with Siemens, which is operational, developing positively, and this morning, another agreement on the same product. Quite a busy quarter. We are happy with, satisfied with the activity during this quarter and also these few days after the quarter. If we break down the sales, you will see that, in absolute figures, it is Europe that has been the biggest contributor to the sales, with NOK 17.3 million compared to NOK 12.4 million, same quarter last year. You also note that sales to Asia is down by just over NOK 1 million. This is due to continued lockdowns in some major Chinese cities, and that has had an effect on the demand for Cystatin C. We don't see any other effect for Cystatin C in any other markets, really. As I briefly mentioned on the previous slide, you see that there is a percentage-wise large increase in sales in the U.S. going from just over NOK 500,000 to NOK 2.6 million in this quarter. That is mainly Cystatin C. Looking at the product split, you'll see that this quarter we have growth in all the segments we report on. Despite China being on the weaker side, we still report growth on Cystatin C. The really biggest contributor to the growth is fCAL turbo, where we have had nice development, continued good development on kit sales, but we also have effect of Q3s this quarter. Nice contribution there. The other revenue part is smaller products that we don't report on separately. That would be CCRP and our fPELA product and the third-party distribution activity that we run out from Sweden. We also see continued growth there. We also have another revenue booked in the P&L. For those of you who doesn't know us that well, that revenue is related to tax breaks and grants, which we are awarded based on our R&D activity. Total about NOK 2 million from that activity as revenues this quarter. Cost-wise, we have an OpEx of about NOK 80 million this quarter, which puts it sort of in the middle between what we reported for the Q1 and the Q2. Normally, we have an increase from the third to the Q4, so we expect operating expenses to increase somewhat for the last quarter of this year. We are quite conservative in our R&D costs treatment. We capitalize only when products or projects are quite close to completion. Capitalization on R&D this quarter was NOK 1.2 million. Last year, it was NOK 3.9 million and that was related quite much to the finalization of the COVID-19 antibody test. Looking at some of the balance sheet parameters, we have positive free cash flow this quarter. That's an improvement of almost NOK 8 million compared to the same quarter last year. The reduction or the improvement in free cash flow comes from a reduction in working capital. We've had a strong development on the accounts receivables, but we have also had our tax settlement received in September. Normally that's a Q4 item, so that's a timing effect of about NOK 5 million. CapEx, we'll be taking both the capitalization of R&D expenses and equipment CapEx of NOK 3.1 million. The equipment CapEx is less than NOK 1 million here. That is, I think, more the normal level for CapEx going forward. In the first half, you remember we had booked quite significant amounts on CapEx due to the plant expansion here, which is now completed and we now see only maintenance CapEx going forward. Working capital, just to mention on that, very good development this quarter. We do not expect to have this low level of working capital on a permanent basis, so we believe that it might increase a bit again in the Q4. With that, I leave the floor and the screen again to Hilja to give some closing remarks before we start with the Q&A. Please submit your questions in the questions box if you have any. Thank you. Thank you so much. I would like to conclude our presentation this morning, by recapping our long-term ambition and respective strategic goals, and somehow taking that in context of our achievements in Q3. We have the ambition to grow our business significantly to NOK 1 billion, within four to six years. During these years, we expect our established products to grow 20% or more on an annual basis. Looking now back to Q3 and the year-to-date performance, I'm pleased with what we have achieved so far. An accelerator of growth is expected to come from GCAL. We continue to demonstrate the clinical value, but of course, speaking about the commercial element as well, gaining commercial partners, but as well the support and trust of key opinion leaders. All of that has happened in this quarter. As well, I'm quite pleased about that. With NT-proBNP, we have another growth accelerator and the development needs to be finalized. We are quite pleased with the progress made for this quarter and more to report as we have made more progress on this. We have as well additional product in our pipeline, and of course, as it takes several years to develop product, their influence on our four to six horizon is lower, but it should not be underestimated. Therefore, we have product in pipeline, and we are pleased that we have moved now the second product into the so-called proof of concept phase, which is an early phase, a phase where the chance of succeeding is still relatively low. Therefore, our general communication strategy is not to speak about those projects in detail, as we may stop them as well due to technical reasons or as well because the business opportunity is not confirmed throughout that phase. During Q3, we have made progress by shifting one product into the let's say pre-development phase and another reason to be pleased with the performance of Q3. We have mentioned today our great news about adding another contract with a major player in the clinical diagnostics market, and we have the strategic goal to achieve at least one per year. We have now already achieved five this year and for several products. This is as well what is important that we start with Cystatin C and that we have with GCAL as well now continued to increase our commercial footprint. From a financial point of view, we have the aim to increase our gross margin from about 50% today to 60% based on the increased volume to be expected during the next years. With cost discipline in place, we have the ambition to achieve EBITDA margins long term in the area of 40%. Boiling a little bit down from long term, four to six years, to what you can expect to see from us in the next 12 months. For the established products, we are continuing to gain, or we aim to gain additional large commercial partners all over the world. We aim as well to bring additional products to the market. We have as well the thought and have opened ourselves to include the first third-party product into this based on the great success we have as well with our distribution efforts we made in Gentian AB, reported in earlier quarters. With GCAL, we aim to continue to secure global commercial partners focused on the EU to start with. Those negotiations, especially with early biomarkers in the market development, take much longer time than for established products. Continue as well with the clinical study program. We have good collaboration with key opinion leaders all over the world, and this all together will lead to publications to be expected within the next 12 months, which further support the clinical support and the clinical proof source that about the value of GCAL in severe infections, but as well inflammation. For SARS-CoV-2, I mentioned before, it is a product we have developed, strongly supported by the Norwegian government, as well with a key opinion leader here in Norway. It is now up to the government to decide if they aim to better understand the immune status of the population. If that is the case, we are ready to provide a very powerful tool to laboratories. With NT-proBNP, great progress made to be continued. We aim as well within the next 12 months to publish information about our reference method, which is a tool to allow or to support the market with the standardization, harmonization efforts of results. By doing so, we obviously continue to secure endorsement of key opinion leaders in this field, in addition already to the already established scientific advisory board. That was, I believe, my last slide, and we are ready for the Q&A. All right. Thank you, Hilja. I will moderate the Q&A. Please feel free to post questions in the questions box you have on your screens. I think we'll start today's Q&A with some of the questions that we have that we see here related to GCAL and today's announcement of this contract with GCAL. I think we say in this announcement here that we expect a roll-out of GCAL during the first half of 2023. Mm-hmm. Could you give a bit flavor and comment a bit about how this relationship with these big distributors or players works after we have signed the contract? That is when a completely different kind of work starts. We have put all our efforts now to sign this contract. During that period, we have validated, qualified our value proposition and the robustness of the product and the need in the market. This is now written in a contract, but now we have to make hundreds of employees, mainly commercial employees, being aware about this new item. In parallel, there is still a step called validation, which we do now as we speak, to make sure that the product works perfectly well on the instrument of that partner. That requires a few months of work because we don't want to see any problems with new customers in the field. It's better to know about that before, and then we can fix it, and then we roll it out. This will take now a few weeks or months. In parallel, we do the training and awareness of our partner employees. We are involved, directly involved in trainings and as well in the development of material, sales material and marketing material. Okay. Substantial amount of work. Yes. Still needs to be done. Yes. Also from our side, in order to entertain and capitalize on. Yes. On this contract. I think that is very important, what you just said, as well from our side. It is not possible as a partner of those companies to sign a contract and to go away and say, "Now please order, and you do with the product what you want." In fact, they don't want that. They want to be supported from the originator of that product, because they have so many products to sell. Mm-hmm. They need us being focused on that line. Mm-hmm. Understood. If we look at some more detail around that contract, question here, is we say that this agreement covers inflammatory diseases and infection, and in other words, does it include sepsis? You might want to comment a bit about sort of sepsis and the problematics around the diagnosis and. Yeah. Yeah. Yeah. Very, very good point. It is as well important to differentiate between what a tool like GCAL does and what the effect is. What we do with GCAL is we detect the reaction of a body to an inflammation reason and inflammation is somewhat as well an infection. The infection is the more severe part of causing a potential disease. Sepsis is a disease which is fatal, at the end of the day, in a high percentage, people die from sepsis. In order to avoid the status of sepsis, clinicians all over the world aim to detect an infection as early as possible, even before the fever comes up, and treat respectively already early enough. As earlier to treat, as higher the chance is that you avoid sepsis. That is here the difference. We target infection, so detection of infection in early in order to avoid ultimately the development into a sepsis. Was that clear? Yeah, I think so. Let's see if there's some follow-up on that. Related to market and our initial launch that will be in Europe, there's also a question here of what other countries or regions that we are looking at. The question is, who will be responsible, I guess, for the regulatory approvals? Will it be our partner or will it be us? Yeah. We focus as we speak on Europe, and that makes a lot of sense because we have with the IVDR certification, as you just heard from Njaal, one of the great achievements for within Q3 as well for GCAL. The focus is on Europe, and that will keep us busy for the next months, potentially years. In parallel, we are looking with our partners, not only for GCAL and this new contract. In fact, we are looking constantly with our partners which countries do we go from a commercial point of view and start registration. The registration process is in the major countries, long. That means we focus on the growth in the next year or two or more is from Europe. The growth for three years and beyond is coming then from other countries. Mm-hmm. Because the registration process takes time for key countries. Having that said, there are smaller countries which we will go after definitively, but big milestone-wise, it's a question of years. To the second part of that question, who is in charge, that is very dependent of the contracts in place, and especially now for this recently announced, we agreed to not speak in public about that. Okay. Thank you. I think that's some additional detail and information about the GCAL contract. A few questions regarding revenue. One here is sort of whether we are satisfied with the growth in revenue so far. I think I can answer that. I think we are quite satisfied with the growth on existing products that we have seen in the second and the Q3 of this year. Q1 was a bit on the soft side, but we are seeing now a good increase. When it comes to GCAL, we are of course impatient. We want more. This is a market development project and we work on that and the results are starting to show with these agreements. When we have these agreements, if we work on those, we will see revenue on GCAL picking up. That's the ambition. Having said that, as you know, we recently expanded the plant, multiplying our capacity with a lot. We have production capacity, we have shipment capacity. We can take on more. We can take on more growth. We can take on higher volumes. That's what our marketing and production people work on almost every day. I think, yes, we can say we are on one side, we are satisfied. On the other hand, we can do more. That's what we are working toward. We always want more. A question on the U.S., Hilja. Could you provide a comment? I mean, we go from, let's say NOK 500,000 to NOK 2.6 million in the U.S., while we have NOK 17 million of revenues in Europe. Could you elaborate a bit on maybe the potential or how we see the U.S. developing going forward. The United States market is a great opportunity for us. We have made limited investments earlier. Due to Corona, the yield of these investments have been somewhat delayed. What you just described on the low level is confirmation that when you do the right investment in the US and don't believe that you can run a successful business as a European in the US, you need to be local, you need to be there. The market is very different than European or as well as an Asian market. Be there, we are there, and we see the results now. As we go, we have obviously as well the aim to further build that business in the United States. There is as well this element of registration, which we had just discussed before. The U.S. has a different market access registration, so-called FDA approval or clearance, and that is a different process than the IVDR. Very similar thorough and requires time. As well, the positioning of products might be different in the United States. Mm-hmm. Be first there, be local, understand the needs of this market, the dedicated needs, and position the product and do the registration. Mm-hmm. This is mid to long-term opportunity for us. When we look at our current products, so for Cystatin C, we have a 510(k). For fCAL turbo, our partner Bühlmann has a 510(k). For fPELA and CCRP, they are exempt from registration. Yes. Is there any reason, let's say long term, that our existing product portfolio should have lower sales in the U.S. than what we are currently doing in Europe? As I said before, the markets are different. Mm-hmm. For example, the fCAL, the examination of stool in the US is less popular than in Europe. Mm-hmm. While we say that, there is a trend that this is increasing. Mm-hmm. That is one of the reasons why you see there a lower demand than in Europe so far. Mm-hmm. Of course, our partner Bühlmann is working hard to change that as well with our partners like we have mentioned before, Roche. Powerful partners. Together we make the market aware, and we see positive trends as well in those markets. This is the reason why there are differences. Mm-hmm. Cool. Thank you. Yeah, I think we have, in fact, there was not a lot of questions today. I think we have then come to the end of the list in fact. With that, we wanna thank you for attending this webcast. We will be back again in February, date to be announced, with our Q4 results. Thank you very much. Thank you.