Gentian Diagnostics ASA (GENT) Earnings Call Transcript & Summary
July 9, 2026
Earnings Call Speaker Segments
Matti Heinonen
executiveOkay. Good Thursday morning, everybody. Happy July, and congratulations for your football success so far in the World Championship. My name is Matti Heinonen. I'm the CEO of Gentian, and I'm here with our CFO, Njaal Kind, to present our quarter 2 and first half of '26 results. Here are the needed disclaimers. And before I give a short update and presentation of Gentian and before we deep dive into the results, let's go directly to the highlights of the second quarter and first half of the year. So we had the record high Q2. We had realized sales of almost NOK 50 million, which is plus 14% compared to Q2 last year or 20% organic growth. And with that, we mean currency fluctuation corrected growth, which is more the underlying volume growth. We had sales to the U.S. NOK 10.4 million compared to NOK 7.2 million a year ago. EBITDA NOK 8.1 million compared to NOK 1.7 million last year, Q2, and gross margin returned to our desired level at 55% compared to 44% Q2 last year. Some additional highlights of the quarter. We are really happy to see that the 2 major key markets, Europe and U.S. are growing really well. Europe grew by 21% and U.S. again, closer to 50% quarter-over-quarter last year. And these 2 regions luckily more than compensated the softness we see in China, and we will come back all these numbers and reasons later. We are really pleased also to see the fCAL Turbo and the whole Buhlmann franchise, delivering nicely. fCAL Turbo increased by 35% in Q2. And also, together with fPELA, they are contributing, and we expect them to contribute nice growth this year and going forward. Importantly, we implemented a new R&D strategy in Q2, and that is to support a more disciplined prioritization of R&D resources and capital allocation. We will maintain the current R&D spending because, as you will see later, we have a lot of going on at Gentian. But we are really targeting a return on capital employed of more than 20% on new projects. And then we were really happy already in June to announce the first of hopefully many new partnerships with the Dutch company Essange Reagents, where we are exploring several assay development collaborations with them. And again, I'll come back to that later. So that was the quarter 2, really good performance, and we're really pleased to see what's going on commercially. When we look at the first two quarters together, we again recorded double-digit organic growth. Sales almost NOK 94 million, which was plus 6% or plus 12% organic growth. Sales to U.S. again, significant growth to NOK 19.1 million from NOk 10.9 million a year ago. EBITDA at NOK 13.1 million compared to NOK 15.7 million and gross margin stable at 54%. Njaal will come back to these numbers as soon. And again, some additional first half of the year highlights. We had very good performance of Cystatin C, like I said, especially in the U.S. But despite that, we decreased by 9.7% compared to first half of last year. That is mainly due to softness in China, like I said. And as you know, that has been going on already for quite some time. but we haven't had a major impact luckily from there. And also order phasing to our South Korean partner, who are actually increasing their sales and forecast. And because of that, they split their traditional true orders per year to 3 and we got one order from them during the second half and we are expecting we're getting two orders on the second half of the year. So the sales for them, which impact both GCAL and Cystatin C are more on the second half of the year. Again, U.S., the first half of the year growth plus 33%. Still we say here adjusted. That is the warehouse shift that happened last year April. So Q1 was still impacted European and U.S. sales split by this shift but Q2 and going forward will be apples-to-apples, which is -- will be easier for us and for you to understand the numbers. That is really building on the great momentum of Cystatin C, but also our -- and our partners' increased investment. And again, fCAL turbo and fPELA turbo, very good performance from our partner, Buhlmann and we expect them to deliver a solid growth to say the least for the full year and hopefully also going forward. And then for the second time ever we pay dividends as a company in May, NOK 0.6 per share, and that was based on the solid cash position. We have sound underlying earnings, and we have all our growth opportunities fully financed. So these were the quarter 2 and first half of the year highlights. Now I go quickly to talk about Gentian. And before I hand over to Njaal, and then I'll come back for the product and R&D updates. We have renewed our mission. So here, you see our new mission that we work for every day here at Gentian. So we are here to improve patient outcomes with a world-class diagnostics. We also stated the company vision. So what we want to be longer term and we want to be and will be the innovation partner for global IVD companies in short. So this is us in a nutshell. So as most of you know, we are a med-tech company serving a diagnostic segment worth USD 1.9 billion, which typically choose areas that are growing above the market average. We were with a ceiling value proposition we can operate through a lean business model, and we have a focused growth strategy. We have industry-leading capabilities in-house and especially strong focus on R&D and operations. As you can see on the right hand left-hand side, we are a commercial-faced company, making profit. And again, equally important, as always, high quality is key for our success and for our customers and focus on ESG. Here, you see the key products we have. So we have 5 established products, one in market development and now on new project stated here in moving to the late phases of product development. The key disease areas where we, at the moment, operate our inflammation, infection and kidney disease. And as you know, Cystatin C, our first product launched already in 2006 is the biggest product of ours at the moment, and that is exactly used for the diagnosis of chronic kidney disease. The next two, fCAL and fPELA turbo are commercialized exclusively by our Swiss partner, Buhlmann Laboratories, and they are focused and specialized on the fCAL testing among a couple of other areas. And this has been and continues to be a really good and fruitful collaboration between the two companies. We have one product for the vet market. So CRP for dogs. Then we have an in-source product from some years ago retin-bilding protein, which is still filing its way. And then we have our own car protecting for serum and plasma which is in market development. And especially in the report, we give updates about the data generation we have achieved and are doing for that product. And then we have this one still undisclosed assay for undisclosed partner, which is one of the top 5 companies. It is progressing well. I will give a short update about that later, and we are still aiming and on track to launch that product together in 2027. And here are the key drivers for our long-term growth and then some key financial KPIs for the time. With this one, I conclude the opening the highlights, and then I hand over to Njaal, who will go through the key financials and then I'll come back for the product update. Over to you, Njaal.
Njaal Kind
executiveAll right. Thank you, Matti. Good morning. I will make a rundown of the financials. My name is Njaal Kind, CFO of the Gentian Diagnostics. Starting off with both geographic and product split. This morning, we announced revenues of NOK 49.8 million for the quarter and NOK 93.7 million for the first half of 2026. Growth compared to the same quarter last year was 14% adjusted for currency. So currency neutral organic growth. The growth came in at 20%. For the first half, the growth is 6%, and then again, adjusted for currency movements, 12%. As you can see, we had strong growth in the U.S. reporting NOK 10.4 million. That is up from NOK 7.2 million last year. And that is a 44% growth, for the first half the growth is 73%. So quite strong. We see the opposite picture in Asia, where we, in fact, had a decline to NOK 7.4 million revenue in the second quarter from NOK 9.8 million same period last year. And that is due to, let's say, a soft development in China. Historically, we have seen sales being quite choppy to China. Last year was quite good, year before that was quite weak. Now we are seeing some weakness, again, difficult to really predict which way this will go also on a quarterly basis. Other markets in Asia has proven quite good, and we expect also those markets to -- countries to do well in the second half. In Europe, growth is good, 21% on the quarter. And here, it's fCAL, fPELA, so the Buhlmann franchise, which is doing -- performing positively in the quarter. So as you can see, fCAL above, if we go to the product split, we see that fCAL turbo has NOK 17.3 million of sales in the second quarter and compared to NOK 12.8 million in the same quarter last year. Cystatin C, overall is very good, NOK 18.3 million for the quarter and [ NOK 1.7 million ] for the first half. Overall revenues at a record level, as you can see. Jumping to the fixed cost level. Not a lot to say there because it's very stable. As you can see, we have not capitalized any development expenses in the first half. But comparing the back, we can see that the overall expenses are quite stable. R&D expenses looks to be increasing significantly NOK 9 million compared to NOK 6.7 million in the second quarter of '25. This is due to the fact that we have stopped capitalization, and we are now booking all R&D expenses over the P&L. So if we adjust for that on the total OpEx, we see it, in fact, down with 3% when we compare to the second quarter of '25. So the capitalization effect in the first half is, in fact, NOK 4.2 million that, let's say, has not been put in the balance sheet, but that's been expensed over the P&L, and that was not the case last year. Looking at the gross margin. As we have said, we should be in the 55% to 60% range. When it comes to gross margin, this quarter, we report 55%. So this has to do with a relatively high revenue level and decent smooth operations in Q2. It's becoming more challenging to keep this gross margin level with the currency or the foreign exchange levels that we do see that we have seen during the -- at least the quarter 2, again, quite volatile currency environment these days. But of course, we are exposed to a strengthened EBITDA. We report an EBITDA of NOK 8.1 million for the quarter and that is an EBITDA margin of [ 16.3% ]. Now again, in order to make this comparable to the historic levels you see, the capitalization effect here is NOK 2.2 million. So if we had capitalized NOK 2.2 million during the quarter, in fact, the EBITDA would have been slightly above NOK 10 million, which is a satisfactory level at this revenue level. Looking at the balance sheet. So we are reporting a cash position of NOK 79.3 million. That is very close to where it was the same period last year. Bear in mind that we have recently paid a dividend of NOK 9.3 million. So that's an increase of 50% from what we paid last year. We have an increase in the working capital in the second quarter. There are some large accounts that is driving that increase. And that is normal variation, and we expect many of those accounts be settled during July and August and that the working capital, in fact, will come down during the third and the fourth quarters. On the CapEx side, you see that we have a very low CapEx and that is due to the fact that we are not capitalizing on the R&D projects. Free cash flow, minus NOK 3.3 million. As I said, that is due to working capital movements. Yes. I guess that was all for me in this section. Please use the questions box on your screen if you have questions, and I'll be back to moderate the Q&A session when we get there. So I hand over to Matti again for the product update. Thank you.
Matti Heinonen
executiveThank you, Njaal. So let's go a little bit deeper into the key product and their performance. Cystatin C, like I said, all-time high quarter driven by growth in the U.S. and in Korea. So NOK 18.3 million in second quarter and growing 5%. The year-over-year increase is really mainly driven by the U.S. and coming from all partners. And like I said, we are investing more in that market. We just added 1 more headcount in May but also we see and work for improved and more closer collaboration with the partners in the U.S. And that ordering pattern I already explained. So instead of half of the sales in first half, we got 1/3, and we are expecting 2/3 of the sales for Cystatin C coming on the second half of the year. Really, the underlying demand for Cystatin C is driven by the updated guidelines and the investment levels and it happens across the markets. And we do expect Cystatin C to be a key product for Gentian also going forward. And we are working hard to be recognized as the Cystatin C company in the world. fCAL turbo again, like I said, excellent second quarter performance with expected high-teens growth for the full year. So last year, as you see, the Q2 was the lower one. So that's why the 35% growth. But still, we do expect very good growth for the full 2026 compared to last year. And then this is driven by Buhlmann adding several new customers, accounts both in Europe and in the U.S., and they have a couple of really good important negotiations going on. And in addition, their old and newer partners are also starting to deliver, and that contributes to the sales. So we can say and be pretty confident that the Buhlmann franchise will be a key growth driver for this year and going forward and the collaboration between the two companies is really good. The other products category, which consists of cCRP, fPELA, GCAL and RBB delivered 16% growth. So again, really good performance and NOK 8.2 million compared to NOK 7.1 million last year same period. The forecast from our partners for the key products are good and they remain on the communicated targets, so we can have good confidence there. And I want to especially mention fPELA performance. As you know, we don't, at the moment, yet report separately the sales and growth, but fPELA delivered even higher, clearly higher growth than fCAL during the Q2 and first half. And Buhlmann, we are expecting that to continue. So fPELA is really ramping up at the moment. And one reason is that because from the same collection tube they use, the customer can make both assessments, fCAL and fPELA and this upselling of fPELA together with fCAL is really driving the sales nicely. And then when we look at our distribution business in Nordics, the third-party products, they had a good quarter, NOK 6 million sales, so among the top highest ever, but still minus 6% because last year, the Q2 was really good, NOK 6.4 million. The start of the year, Q1 was a bit softer. We communicated then that, that was due to delayed orders. And we did see a lot of orders coming in now in Q2, and the order book is and keeps bidding nicely. So the team is confident for the full year deliveries and results. The organization continues to further find customers on the Nordic region and also looking for additional products to their portfolio to have the growth in the future as well. And again, we have had a couple of smaller but also a bigger win or able to secure a multiyear contract with a major partner recently. So all in all, this third-party product sales and the business looks good for us as well. So that was all about the sales and financials. And one of the key updates of today is actually the R&D update and summary. So -- and I will now cover that one as well. So I want to spend a little bit more time here. So after the NT-proBNP decision that we communicated in May, and of course, getting ready for the situation. If that happens, we have been looking how to be more efficient at Gentian. We have built actually a new R&D strategy and the aim is to accelerate new product launches and manage also the risks of these projects. So going forward, our R&D strategy is built on 3 pillars. I go first through them a bit faster, and then I may take some points up also later. So first of all, we want to have more product launches. That is obvious. We haven't launched products in many years, and that has to change. So we will have a much more dynamic pipeline management approach, which combined with more agile development processes, meaning faster development, will and should [indiscernible] in more launches in recent -- in coming years. Also, we will more officially increase focus on the vet market building on the success of cCRP and we have great relationships with the key companies in that area. And that is a very good starting point to either convert existing products from human to vet, which is easier and less regulated, but also to develop new products for their needs. Second point is expansion to point of care through partnerships. So there is a [indiscernible] biometric point-of-care segment, which is attractive adjacent opportunity that we haven't exploited in the past that much. Actually in the pet area we have, but not in the human diagnostics. Our existing assay portfolio and our development capabilities are well fitted and suited to being integrated or to develop products to be integrated on partners' platforms. So -- and also then a bit longer term and combining the [ 0.3 ] the emergence of the high-sensitivity technology, which will be especially suitable for the point-of-care platform that will further expand partnership and assay development opportunities in this area. And third, last but not least, really, we are now increasing and solidifying our focus and investments on the high sensitivity technology. And the reason is that the key limitation of pet assays, the traditional assays Gentian has been and will be producing the sensitivity. And that means that we don't have united number of assays to be converted to polymetric assays. With this high-sensitivity technology and our data so far that has demonstrated up to 100x improvement in sensitivity, which when we analyze the assays and our biomarkers, which exist can lead up to roughly 100 additional biomarkers being within the reach for this technology. So one can understand that would have a really big impacts and really game changer technology in this area. And that technology is in theory applicable both for point of care and core lab instruments. But like I said, the smaller point of care instruments are the easier and first step for us and the partners forward. Then -- so this is -- these 3 areas with this, we are aiming to clearly accelerate the number of product launches and also to manage the risks. And what does that mean? I can especially -- actually elaborate the dynamic pipeline management approach. So the biggest change to the past is that we used to have one or two development projects that were decided and run then until the end. But now what we will do is that we will have several projects running in parallel. We will do early exploratory work. We will generate early data to have good pitches and then a very important decision, no go or go point will be commercial interest or some sort of partner commitment or interest for the project before we put the pedal down and invest all the way. In this way, we can explore much more assays or projects at a time, and it will be a combination of our in-house highly innovative projects, combined with the business development driven in-sourced or collaborative projects. And all that should also manage the risks of failure or increase the probability of success. And we are not only in more talking. We do understand and know that after the NT-proBNP decision, there were many questions rightly so that what's the future of Gentian and what's there of that project. And we are happy to reveal, now already quite many projects, we are working on. But this is not actually even all, but before I go into them, a very important disclaimer for this slide and whatever we disclose going forward. And that is that we don't expect all of them to succeed. So when we work on several projects and we do the feasibility and exploratory work, and we have the partner commitment as a key go, no-go decision, any of them can fail at some point. But that is exactly the way, so innovate, fail fast and then move on once you have a higher probability of success. But do not expect or do not be surprised if going forward, we need to inform you that one or a couple of these will not move on. That is exactly the the idea of the more dynamic but broader pipeline management. So first, let's -- again, I want to also reiterate something that we have had many questions that is Gentian moving away from being an innovative company and only becoming a service partner, and that is not the case. So the focus remains in proprietary assay development, which will be then complemented by, for example, pay development partnerships and technology licensing and collaboration opportunities. So it will be a balance and mixture of these kind of projects. And you have and we have here examples of all of them. So on the left-hand side, on the top, this is the ongoing assay development that already made to the product slide as well for the key IVD partner. And the good news is that our team in Gothenburg, the early research team has concluded their job. We seem to have, data shows now well-functioning assay in our hands, but of course, further work is required, and the development is now moving in July to MOS, where the final stages of the development are done. And like I said, the project remains on track for quarter 4 -- sorry, 2027 launch with the partner. And whenever we are able, we will obviously once the biomarker and the partner. Then we have this recently announced partnership with the Dutch Essange Reagents. They are a company with a strong portfolio and create assays, but not all of them or not on the clinical chemistry or PETIA platform. And that is where Gentian comes into the game. So we will and are exploring the collaboration to bring first already a couple of assays to PETIA platform. We are already in the phase that our labs will start testing those assays now in July, August. And at the same time, we are discussing the commercial terms of the future collaboration. And this could be at the best, something like our collaboration with Buhlmann, for example, similar kind of strategic partnership. And what is also important that these assays are for existing markets. So no market development as such needed from scratch, and there is interested partners or partner or the assays. So that -- those -- or this project partnership ticks many of the boxes that we require going forward. Then in addition, we submitted in early June an offer to do -- pay development projects for a major vet IVD company. And that includes also option to act as a test manufacturer and that will typically be the case. So we may do sometimes just development, but our business is in manufacturing the tests, and that is our base case always. So we are expecting a decision in the near future, and we'll give updates when we can. But this would be very important and very quick step to that debt area that I mentioned in the previous -- the slide. Then so far, we have been discussing about the high sensitivity technology more on just our own exploratory work and having high hopes. But we are also happy to say that much more concrete things have been going on and are going on. So with the first partner, the co-development collaboration for the high-sensitivity point-of-care instrument has started, and that company will start now building a prototype of their current instrument, having the high-sensitivity technology inside. We have commercial terms again under negotiation, and further information will be provided when we are ready. But that is really, really exciting opportunity, and the partner is also excited about that. And we are trying to expand these collaborations going further. And then in addition, in-house, we have initiated 3 projects. One is a product improvement project for our own product, existing one. And then we have -- or we have actually initiated two early stage exploratory projects for new PETIA assays. So one is a biomarker for cardiovascular disease, which is not NT-proBNP and the other one is for liver disease. These are early, but going in different phases, but they represent these in-house proprietary assay development. when many others you see here are more the partnerships. And this is exactly the balance of the pipeline, again, that we want to have going forward. And like I said, this is not even all, but these are the ones we can, at the moment, mentioned at this level. I know you are hungry always to learn more, but we have to respect our partners. Sometimes there's more than two partners in the negotiations, and we do always our best to inform you as soon as we can and are required to. Then last slide about R&D. So we want to, again, say that the R&D spending will remain. So we will remain as a new innovative company, but just looking to be much more productive and have higher return on capital employed on R&D. And this is due to the fact that, as you saw, we have many, many projects ongoing. And at the moment, we can manage those with our existing resources, but obviously, especially if they are paid developments, so we don't have to take the monetary risk of the development ourselves. That gives us an opportunity to investigate even adding resources if needed. And if several projects successfully move on. And then also, we want to just mention here that our VP of R&D we signed in June. And we are in -- or we have started the process to hire a new lead for our R&D, this I have now talked about to you and taking our R&D capabilities and deliveries to the future. So we hope that will always take some time. But hopefully, by the end of the year, we have there news or somebody already in place. And on the right-hand side, you see already the traditional breakdown of the spend because we book under R&D also the technical and clinical support for existing assays and the pipeline development is really the new assay development. And now as you see and Njaal mentioned that we didn't capitalize anything in Q2 due to the termination of the NT-proBNP project and others not far enough yet to be capitalized. So with this one, we actually conclude the quarter 2 and first half of the year presentation. And now it's time for Q&A.
Njaal Kind
executiveAll right. Thank you. There's been a good number of questions coming in during the presentation here, Matti. Let's start with more of the original questions first. And Cystatin C, we have a few questions regarding that. Let's say, both geographically, but also new customers, existing customers. And are we able to separate fully new business and existing business? And the question is also where are we winning new business?
Matti Heinonen
executiveSo several questions. Geographically, U.S. is leading and typically both in diagnostics and pharma, the uptake is faster due to their health care model, reimbursement model. So there, we do see the fastest uptake of Cystatin C. And just to remind, Cystatin C is mainly used together with creatinine, which is something you may recognize that when you take your normal test panel, creatinine clearance is something that is used to indicate how your kidneys function. But there are certain situations when creatinine is not enough or sufficient and Cystatin C adds value. And that guideline update that happened already more than a year ago, that has really, really supported, but it always takes some years. But Europe is coming. So it's not that, that it's only U.S. growing. So Europe is also coming up. And we do think that Cystatin C will be a major product for us and major biomarker going forward. And that is -- the opportunity there is that there's -- as you know, again, in diagnostics, we don't have a exact data of market shares or usage as again, for example, with the pharmaceutical products, but some data indicate that maybe maximum 10% of labs in the U.S. that measure creatinine measure also Cystatin C at the moment. So the other way around, 90% of the labs are still naive for Cystatin C testing, and that is exactly the opportunity and those that our partners and ourselves, we are directly targeting. And the fact that we have two partners in the U.S. that both have actually quite nice market share of the total instrument base. So that gives us already existing opportunities there. Then the new sales, that is true. We didn't report now actually the separation of new sales. We did last year. It was roughly 14%, 15% of sales coming from new accounts added. And we have, again, also added new customers this year. If I remember correctly, it's roughly 10 new accounts, adding and several that we are negotiating. So that is exactly the future growth is that we are more labs using Cystatin C, and we can have a separation between kind of the existing sales and what the new labs are delivering.
Njaal Kind
executiveYes. Just to add to that, that is the minimum. What we can say about new business. When it comes to some of our partners we do not have full transparency if their sales is on existing business or new business, but we see that they are growing. So I think it's fair to assume that they are also adding new business to their accounts, which is then -- has an effect on the demand for our part.
Matti Heinonen
executiveThat was important, yes. That's why we can't -- all the time report like apples-to-apples because we don't get the data fully.
Njaal Kind
executiveCorrect. Let's stick to Cystatin C, the question about these KDIGO guidelines. Do we expect any further changes to the KDIGO guidelines that could impact the adoption of Cystatin C?
Matti Heinonen
executiveI haven't heard, and I'm not aware the guidelines per se being actually the limiting factor. What we do know that what could really open up and will open up this market is actually changes in reimbursement. So the current reimbursement in the U.S. doesn't cover all the patients that are covered by the guidelines. And that is something that, especially the partners, the key players who know the U.S. market and have big departments, working on the reimbursement changes are driving those. So once we -- and they can get broader reimbursement based on the guidelines that will drive especially the future growth.
Njaal Kind
executiveThank you. Cystatin C in China. So as we spoke about, it's choppy. Now we are seeing a decline. And yes, we have also previously spoken about that there are changes in the environment in China. And the question is, is the revenue level we now see, is that sort of a new structural baseline? And secondly, what do we assume for the future when it comes to sales to China?
Matti Heinonen
executiveBut the latter one, I guess, we and many other companies can say that we don't know fully, that market has and is changing rapidly, and the transparency is not always clear. And the competition is obviously massive and it is splitted between the foreign company segment and then a huge number of local competitors. I have to say when we or if you look at, for example, the key IVD companies and how they have in many quarters back, reported their sales in China, we have seen like tens of percentages declined in their sales, which keeps going. And I would say probably longer than expected. So us not growing, but being able to roughly keep the sales level where we have been, I think, so far has been a success. I would like to knock the wood, if there were any here. But our approach to China at least, is to keep close to our local partner, Beckman, which we do get as much information as possible, support them to our best and try to defense the market and the sales. And then when the situation stabilizes, then we can again look at maybe investing more or launching new products.
Njaal Kind
executiveAnd looking at this historically, we have seen significant volatility in sales to China and it's difficult for us to separate between what are let's say, structural effects due to policy changes in regulation, et cetera, and what are effects on, let's say, variations in the supply chain because we have seen big variations in the supply chain previously as well. So this time around, it's the same. We have yet to find out what is the real cause of the decline in China.
Matti Heinonen
executiveThat is true. There has been like very soft months and quarters and then suddenly, they have been back the stock. So -- but we don't have full transparency, like Njaal say.
Njaal Kind
executiveYes. Let's keep still on the operational side. Yes, this question here, it's sort of a hybrid. The question is, we have Cystatin C and fCAL turbo is about 70% of our revenue. And the question is, when do we expect sort of another biomarker, either one of those we already have or one of the new biomarkers that we are investigating to come in and contribute with meaningful revenue? Is the question here.
Matti Heinonen
executiveAnd that question obviously addresses a key risk. Luckily, we're not one product company, but we are very much dependent on these two products, which, again, are doing well, and the outlook is good. But still, that is a risk to manage. GCAL has taken a long time. And as we have communicated, we pivoted our focus from the primary focus from infectious and sepsis to rheumatoid arthritis, which seems to be a better area, but still it is a slow start there. But we have also allocated actually some -- our sales resources directly in Europe behind the product. But it is really the key reason and the key expected outcome of the new business development and R&D driven model is to get faster new products that can start contributing meaningfully. And we do have a couple of those projects mentioned here or not mentioned that potentially could become equally big product longer term than Cystatin C and fCAL. But that is exactly one of the key reasons to, first of all, sustain the historical growth of the company, where we need more products to support that one, but also, like I said, to derisk being dependent on these two products too much. But how long? And that's also the kind of a potentially benefit and beauty the more business development driven opportunities that for sometime, they expected development time can be much shorter than for a project we start from scratch in-house. So hopefully, in coming years, we can't yet say exactly when, but the CH50 is, of course, coming, but it's not going to be the -- maybe the key products, but a midsized product, but hopefully, in a couple of years, we can launch and already commercialized some new products if everything goes well.
Njaal Kind
executiveAll right. Thank you. Back to Cystatin C in the U.S. Do we -- can we say anything about the long-term potential for the product? And could we also say something about the competitive environment with Cystatin C?
Matti Heinonen
executiveSo last year, at the ADLN Congress, which is now again in a couple of weeks, there was a session focusing on Cystatin C and they show a number of in 5 to 10 years, that market could be in the U.S., only USD 450 million. That is one number, but it still tells that can be a significant market opportunity. FCAL, for example, I guess, is the numbers we hear and talk are USD 150 million to USD 200 million market. So it could be more than double sized market, for example, compared to fCAL. Competition is there, obviously, and it's getting harder. Obviously, when the guidelines change and the sales start to pick up, more companies come in. And likely, the price is still in good and bad perceived high and it's quite okay. So we haven't seen a massive price competition. But we have to, of course, stay vigilant, and we have to keep improving our own products also all the time to keep it competitive going forward.
Njaal Kind
executiveOkay. Thank you. fCAL, the same question. Almost if we can comment on the competitive environment for fCAL. It's a competitive market. Maybe we -- maybe you can say something about, let's say, the advantages of fCAL turbo, which are the main selling points for that test, which makes it quite competitive in the market?
Matti Heinonen
executiveI think should I talk on the time, you can take the lead equally well. But I can start. So that market demand is well positioned, and they are really well known for that one. And a key advantage of Buhlmann their collection device or tube. And it can be used for, like I said, both for fCAL and fPELA. They are even planning to add many new products on the same or separately, will see. But what is important is that, that fCAL sampling and testing or not testing but sampling is becoming more and more home-based. So patients take the sample at home and they ship it by mail. And that collection tube device is really well suited for that, better than many others. Secondly, that is actually one of the most or best automized collection tube. And so that also split the market. So some of the key competitors like [indiscernible] there, their tube is not able to be optimized in the same way. So they compete a little bit on the different volume segments. But the competition, again, there are some companies probably dropping out. and others getting stronger. But Buhlmann is one of the leading companies, and they are -- and with their new owners and new CEO, a new team, there targets and what they seem to deliver already is to solidify their leading position in the future. So I can say we can be. I am actually confident with Buhlmann that they can deliver also going forward really well.
Njaal Kind
executiveLet's move a little bit. There are a few questions regarding the, let's say, revised new approach and strategy. And I think, first of all, and maybe to clarify that, what are we thinking about the positioning of Gentian from -- here it says, as OEM partner, I read that as a contract manufacturer or classic contract manufacturer versus a deeper partnership model.
Matti Heinonen
executiveOf course, terms and how they understood are different. But basically, we are OMT partner per se. So we do tests for the key companies. As you know, we don't have our own instrumentation. We rely on the open channels of these core lab instruments and so on. But still really what we want to be and seems to be also the need for key partners is stronger strategic partnerships. So they are consolidating the key players, our customers. They are consolidating their third-party supplier base, the reliability, the trust, the history of delivering without issues. All that is becoming even more important. And Gentian is actually well positioned. We are getting more and more discussions and calls saying that they want to collaborate, especially and exactly with us. And so that is where we want to be. So we want to be that strategic partner who can do both development but be the manufacturer under Gentian brand or their own brand going forward. So that is not really changing, although the the source of the new projects and products become more diversified.
Njaal Kind
executiveI think it's also important to add here that we also seek a deeper relationship on, let's say, where we can add clinical support. We can add regulatory support. We are not just, let's say, producing and shipping it onwards. We have capabilities in the background, which is very important for many of these partners.
Matti Heinonen
executiveVery important. That is highly valued.
Njaal Kind
executiveYes, we run through the questions. I see that we are 2 minutes to 10, but I think we can go a few minutes over, if there are still interest in listening to us. Let's say, what is the current level of R&D spending? This one, we can answer quite quickly. So for pipeline development, it's NOK 6.6 million. And then we have NOK 2.4 million, which is this technical and clinical support that is related to existing products. So if we say what are our investment component, in new products, that is the NOK 6.6 million. The question is -- third quarter, yes. So the question is, will that continue? Yes, I think as you can see, we are at about NOK 6 million per quarter. So I would say, between NOK 5 million and NOK 7 million, it will fluctuate a bit depending on, for instance, clinical studies or other external projects. But we are clear that we are aiming to maintain the R&D expense level going forward. We are quite busy these days, but we are also well resourced to take care of many of those projects that are on the books right now. Yes. I think we answered a few questions there. Let's go to the high-sensitivity initiative. And as a questionnaire is also stating that this is a potentially, let's say, transformative project that could change Gentian a lot, but it could also change, let's say, the industry. And the question is where are we on the maturity curve of how developed is this project now? And when do we expect sort of either to see some revenue of some sort or that we enter into some cooperation with some along this?
Matti Heinonen
executiveSo well, first of all, the business model there is that we can expect and we do expect to kind of revenue make sources. One is the milestone and licensing fees. And second is then being the kits manufacturer for high-sensitivity kits. So that is very important. We are not developing that technology just to license the technology itself out. We want to be like with the current business also, the kit manufacturer and developer for the the additional assays that can be broad. We are -- what is really important, I, first of all, start with intellectual property. So we have already filed patents for high-sensitivity technology, and we are in-house developing a new, even improved rig to continue that work. So protecting our innovation here is key, and that's part of the development. We have run several biomarkers on the first rig. And from where we have this data showing this impressive increase in sensitivity. And our team says that actually that even up to that 100-fold sensitivity gain has been achieved with very little optimized instrumentation. So once they keep working on the processes and then the technology, we can even see better results there. And so now the next steps are really that we have a concrete partner, which hopefully we can announce at some point once we have agreed on the key terms. But you can understand this is a long-term high investment project, especially from the partner side. So also the term sheet and contract is quite extensive. So licensing fees, milestone payments hopefully quite soon, if that moves on. But then what we have to keep in mind is that before we can develop or register a kit for high-sensitivity technology. The instrument has to be there and registered. And that takes time. So I can't yet because that company is now really starting to sketch and work on the prototype. So I hope we will get some time lines from them later. But they are super excited about that one because similar to us and Immunotec point-of-care companies are also very hungry for or new assays. And with this increased sensitivity, they might be able to build panels to customers that are not reachable or feasible at the moment.
Njaal Kind
executiveOkay. One last question, an easy one. Let's say, regarding our expansion into the veterinary market, are we also planning to have instruments going forward?
Matti Heinonen
executiveNo. So both for high-sensitivity technology and Vet business still, we stay where we are strong, which is the key development and manufacturing and we will partner and collaborate with companies who have their own instrument platforms that we then become experts as we are now and can do the validation of the assays and help them there. But we are not planning to develop our OEM or any Gentian assay platforms.
Njaal Kind
executiveAll right. Thank you. We will wrap up here. There are a few unanswered questions, I can see here on the list. Please reach out to us if you want them answered. We're happy to do that on a one-on-one or e-mail basis. That also goes for everybody else. If you want to get in touch with us, please just reach out. Happy to take the discussion further.
Matti Heinonen
executiveGood. Thank you. So I just conclude by saying that, again, thanking all Gentian staff for the great results and great focus and putting really skin in the game both commercially and in R&D. We are happy to report a strong Q2, catching up the softer Q1, we are confident for the full year, basically, China business being the only clear known risk, but that has been accounted for more or less. And then very importantly, this R&D focus and model of working change with already so many concrete examples that we will then tell you more, we promise whenever we can. We see -- and we are excited about that as a leadership team, as a company, and we believe that, that can change the trajectory and history of launching much more or many more products in coming years. So with this one, stay tuned, have a nice summer. Good luck against England, thumbs up for Norway and see you then in October.
Njaal Kind
executiveThank you. Bye-bye.
Matti Heinonen
executiveThank you.
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