Okay, very good July and summer morning, everyone, and welcome to Gentian 's quarter two 2025 results presentation. My name is Matti Heinonen, I'm the CEO of the company, and I will be today presenting the quarter two update with our CFO, Njaal Kind. It's 9:00 A.M., so let's start the presentation. Gentian , a quick update, but not too long. We have quite a lot to actually talk today about the results and nice updates, so I will be a bit shorter today with the company updates. Gentian , as you know, is a medtech company that is targeting a large $2.2 billion serviceable market, which is growing on average 5%- 10% per year. We have a very appealing value proposition for our customers, both end users and commercial partners.
We operate with a focused strategy on PETIA and clinical chemistry platform, and we have a lean business model that we can choose how to commercialize our products. We have industry-leading capabilities in-house, and especially we have a strong focus on R&D and our operations, and we are also putting a lot of focus on the commercial organization going forward. We are, as you can see from the graph on the left-hand side, a commercial-based company, a fast-growing company, and also a profitable company. We build everything we do here in Moss and other sites, obviously, on high-quality standards, and we have also a strong focus, and we work based on the ESG principles. As you know, we are listed in the Euronext Oslo Børs. We focus at the moment on three key disease areas: inflammation and infection, kidney disease, and heart failure.
We have five established products, and Cystatin C is the kidney disease marker. Canine or dog CRP is used for PET analysis for infections. fCAL , it's the Faecal Calprotectin, one of our two calprotectin products, and that is commercialized together with fPELA through our Swiss partner Bühlmann, and that is used to diagnose inflammation in the bowel, and especially for the IBD disease. RBP, Retinol-Binding Protein, is a quite recent addition, which is in the market sensing, and we are having some discussions about commercialization of that as well. We have calprotectin as GCAL, which is targeting plasma and serum samples, and we are in the market development, really generating data and increasing awareness both in infectious diseases and also autoinflammatory diseases like rheumatoid arthritis. We will talk more today again about our heart failure marker, NT-proBNP, and give you a bit deeper update about the development.
We have four key pillars for long-term growth, and below you see also two profitability KPI targets that we are following. Obviously, the best way to grow the company is to maximize the sales of existing products, and that is something we are doing, and we'll have a lot of focus also going forward. The positive thing is that all our products, they have a lot of room to grow. As said, we need to prove and deliver the clinical relevance of GCAL and then bring NT-proBNP to the market. Obviously, we don't want to stop here, so we are constantly looking at the market, discussing with our commercial partners, end users, and updating our list of future products. We want to bring a steady state of new products to the market, and we will also talk today a little bit about the technological improvements available.
Of course, through the lean business model, in addition to going directly to customers or using distributors, we want to secure at least one new contract with the key global or regional IBD players per year. You see the gross margin and EBITDA margin targets on the slide. Without further ado, let's go to the Q2 results and highlights. We had, after a very strong Q1, when we look at the top line, the revenue, we had another very strong quarter. Our EBITDA, we said last time that Q1 was a quarter when everything went perfectly and there were no hiccups anywhere. This time in Q2, we had some one-off production and raw material issues that impacted our gross margin and EBITDA, and Njaal will explain more about that to you soon.
If we look at the numbers, we recorded sales of NOK 43.6 million, which was almost as high as Q1, and Q1 was the highest quarter ever for Gentian . This quarter represents 14% growth over last year. One of the highlights, but there will be many, was especially our sales growth in the U.S. Compared to last year's Q2, we grew almost 100%, well, 156%, so almost 3x the sales. EBITDA was NOK 1.7 million for the quarter, and that was down from the previous year, and gross margin dropped this time to 44%. Other highlights, if we look at the first two quarters, so the first half of the year, our sales were NOK 88.1 million, which is a nice growth of 15% compared to last year, and 13% organic growth.
Cystatin C, I will talk more about that later, but it was again the key growth driver, growing 31% over the previous year, same time. We can already now start to be quite confident that those value-based pricing tendering issues we experienced last year in China, they seem to be now over, and we are really returning towards a normalized supply situation. In addition to quarterly growth, our business in the U.S. almost doubled in the first half compared to last year, and we keep adding a good number of new customers every month. EBITDA, full year number, NOK 15.7 million vs NOK 11.6 million last year. Overall, taking the two quarters together, we are doing well, and we are on track.
I will end the presentation with a little bit deeper NT-proBNP updates, but as highlights and summary, I can say that after choosing the total NT-proBNP as our strategic choice for the product, we completed further calibration adjustments on several instruments. We tested more clinical samples, and also we secured access and signed a contract to secure access to new patient cohorts that support our regulatory submission plan, aiming for 2026 commercial launch, as communicated earlier. With this one, I hand over to Njaal, and then I come back to do the product and R&D update later. Njaal, over to you.
Thank you, Matti. Good morning. I will take you through the financials. My name is Njaal Kind. I'm the CFO of Gentian Diagnostics. This morning, we announced sales of NOK 43.6 million for the second quarter and NOK 88.1 million for the first half. For the second quarter, this corresponds to a sales growth of 14%. For the first half, 15%. Sales have been driven primarily by Cystatin C, where we have had very strong sales both in Asia and in the U.S. Geographically, you can see that in the U.S., we report sales of NOK 7.2 million compared to NOK 2.8 million last year. However, we need to make a small adjustment here due to the fact that one of our customers changed their warehouse from Europe to the U.S.
The U.S. sales is influenced in the second quarter by NOK 2.8 million being shifted from Europe to the U.S. If we adjust for that, growth in the U.S. in the second quarter was 57%, and year to date, it is 43%. Still growing quite well in the U.S. Europe, making the same adjustment, we had then 3% growth in the second quarter and 6% growth year to date. As Matti also explained, Asia is doing quite well. We had issues last year with the introduction of value-based pricing in China. Our partner in China has done a good job and kept their volumes. We now see that sales is back on track. Good growth in China with 42% compared to the second quarter last year and 36% year to date.
As you can see on the bottom table on the slide, Cystatin C then shows a growth of 38%, 31% in the quarter and 25% year to date. fCAL turbo has had a soft quarter, but year to date, it's essentially flat compared to last year. Matti will come a little bit back to that in the product presentation. For certain pocket products, we've had a quite strong quarter and also a decent first half year with 39% growth on the quarter and 24% on year to date. In the other category where we group the lower volume products, we see very good growth with 31%, 32% both on the quarter and year to date. All in all, all products except fCAL turbo show good growth in the quarter and also year to date.
Shifting to the cost, on the quarterly side, you will always see that there are some variations, especially in R&D expenses. Year to date, we have a cost increase of 3% - 4% on these different groups. That corresponds well to the general increase in cost level, for instance, in personnel cost and also the general cost level that we see. There is no significant increase in cost. As I'm sure many of you have already noticed, we report a drop in gross margin to 44% this quarter. We have to go more than one year back to find similar figures. We come from 64% in the first quarter. That was a quarter where everything went smoothly, everything went as it should. Now in the second quarter, we have had some production issues.
These are issues related to raw materials, where the raw materials start to behave differently when set into production. That has resulted in, first of all, our raw material consumption increasing, but also that we have produced certain lots of one of the significant products we have, which unfortunately had to be scrapped. That, of course, is, literally speaking, a cost that has gone down the drain. These issues that we experienced occurred in April and May. June is back to stable production. We believe that this is a situation which seems at the moment to be resolved. We believe that unless something surfaces again, we should return to gross margins of 55% - 60% quite quickly. Looking then at the EBITDA, if we look at the margin, EBITDA margin year to date, it's 18%. That is also quite good.
It's, in fact, a better EBITDA than we had at the same period last year, where we had 11.6%. The second quarter EBITDA of NOK 1.7 million is below our level of ambition. We will work hard to improve that in the coming quarters. On the balance sheet side, we report a cash position of NOK 80 million. That is basically the same cash position or NOK 1 million lower than what we had in quarter two last year. What is important here is that during this period, we have returned NOK 6.2 million back to the shareholders through a dividend. All in all, the financial position of the company, also then with an equity ratio of 85%, remains solid. We have a question regarding dividends a little bit later in the Q&A here, I see. That wraps it up for me.
Please, if you have any questions, use the questions box or the questions function that is embedded on this webcast, and we will try to answer it when we get back to the Q&A session. Now, for a product update, I leave you back with Matti. Thank you.
Thank you, Njaal. Let's go a little bit deeper into product or product groups and look at the drivers for the performance. Cystatin C, we have already repeated a couple of times, had a very good quarter. The graph on the left-hand side actually shows nicely the dip we experienced last year, especially Q3, which was extremely soft. As you can see, we have had two, I would say, very nice quarters this year. Q1 and Q2, both above NOK 17 million, almost NOK 18 million the first quarter, and record quarters for this product. What is also nice is that the growth comes from several geographies. It's U.S., China, but also South Korea that are delivering the growth. We delivered almost NOK 9.4 million to Asia in Q2.
Also looking a little bit forward, I'm happy to share that we have already a very solid order book for this quarter, Q3, in our hands. We can expect Cystatin C to keep performing very well. We have said, and we have U.S. as a focus area, and Cystatin C is obviously the key product over there. We have invested more headcount to U.S. and we are improving and intensifying our collaboration with the commercial partners in the U.S. They have been really pleased, actually, with our activities and proposals, how to drive our mutual interest and business. As a result of this, we have already, again, added this year 31 new Cystatin C customers in the U.S. Obviously, none of them are probably yet delivering at the maximum. Adding these new customers, and of course, we don't stop here.
The team keeps doing the good work every day and week over there. We can expect a nice sales growth from the U.S. as well, based on this customer base. fCAL turbo, like Njaal said, actually, all other products or product groups have had a very good Q2. This time, fCAL turbo was the one that did not perform as we or our partner Bühlmann expected. As you see, especially Q4, but also Q1, they were good and strong quarters. Now in Q2, the sales dropped 15% compared to last year. Still, that NOK 13 million level is not bad if you look back. Of course, it is not according to the growth expectations. We have had discussions and dialogue, as always, with Bühlmann.
It looks like this was an effect, as still a kind of carryover effect from the docking that happened in Q4 and Q1 in a couple of regions for various reasons, and also some delayed phasing of orders that were expected in Q2. Still, overall, the outlook for 2025 remains unchanged. We also do know that there are new distribution agreements signed. The Beckman agreement from Bühlmann was announced earlier, and they are working hard on others. We know that these new partners should start contributing to sales already in the second half of the year. Overall, despite the softer quarter than expected, we believe that fCAL is still on track to our expectations in 2025. The other products category, which consists of cCRP, fPELA, GCAL, and RBP, performed extremely well. Record high sales, NOK 7.1 million, growth of 32% compared to last year, same quarter.
Especially fPELA and cCRP are experiencing both quarters this year a very strong growth, high double-digit growth compared to last year. GCAL had a strong Q1. Q2 was a bit softer, but overall, taking together the first half, GCAL is also making good progress year to date. Our third-party products, so the Nordic Sales Team, addressing directly the end users, had also actually a record month, NOK 6.4 million. Again, growth almost close to 40%, 38% quarter-to-quarter growth from last year. This is based actually on increased customer base. The team is, in addition to Norway and Sweden, doing a good job adding new customers from Finland. We are working now more in Denmark and have some preliminary indications there for future business. The testing volumes are actually growing and contributing to the sales growth.
We did add actually new resource or headcount last year to our Nordic team, leading the sales team, and looks like the investment and more intensive presence is paying off. Another way to look at the regional growth, you can compare the quarter-to-quarter regional sales on the left-hand side. I would say the two clear highlights here, and despite that warehouse shift that was communicated, is that our focus area to grow U.S. sales is clearly working well. You can see that we are moving from roughly NOK 2 million per quarter sales now, even up to NOK 7.2 million this quarter. Those new customers added, so 31% for Cystatin C and actually four other customers for cCRP, that is really promising for the future growth. You can clearly see the recovery in sales to Asia. China is back on track, and our business in South Korea is even growing.
Europe, the impact is twofold. It is the shift of the warehouse, but then also fCAL being such a big product for us and having a soft quarter that impacted our European sales in Q2. With this one, we conclude the sales and financials and product slide. Now, actually, due to the holiday season, I put on my R&D hat and give you an R&D update. Before we go to NT-proBNP, let's look at other R&D stuff here. I have on the left-hand side three updates to you, and then also I and we can talk a little bit more about the R&D spend. We have done a breakdown of that because there have been some questions and discussions. What is the R&D spending going for? Let's start with the update.
We have communicated to you earlier that we are, or we have an early-stage development project that is done together or in collaboration and for one of the key global IBD players. That project actually progresses still really well. We have, again, done good progress there and moving nicely to the end of proof of concept phase and getting ready to move that product to the optimization phase. I can tell you that the customer that actually at the moment we yet cannot disclose has been extremely happy with it. Importantly and very interesting update, like I said, we don't only focus on finding new products, but also we are looking at how to improve the technological platforms and sensitivity of the assays. We have started some time ago and now increased substantially focus and resources behind an exploration project of next-generation technology platform.
This early work that is now being done in our research center in Gothenburg is actually showing really promising results, and it holds a promise of detection capabilities that might be substantially below those achievable with traditional therapeutic methods at the moment. What does it mean in practice is that it potentially could enable us to enter or bring in biomarkers that have been formally not available for any clinical chemistry analyzer platforms. If this works as the plan is, that could be really a breakthrough, maybe strong word at this point, but very promising outlook for the future. In addition, we did revisit in Q2 our pipeline candidate list at the moment. Again, due to the first two bullet points, that that collaboration project is moving on so well and quickly.
Also, due to the promising results for the technological projects, we have put resources behind these two when NT-proBNP starts to be a bit less demanding for the research team. We have the product list ready, but we will need to make the decision for the next product. It's not necessarily today here, but we will do that during the second half of the year. Whenever we can free resources, the next project will kick off. We have traditionally reported R&D spend as one number, the total number on the bottom line. It is actually important if one wants to understand how we use that money. We did a breakdown of it. If you look at the middle line, which says pipeline developments, that is something that's in the narrow way of considering R&D spend. The new product developments, that line NOK 4.1 million now in Q2, represents that.
We do also include in the total R&D spend something we call technical and clinical support. That can be both for products that are under development, but also for products that are already marketed. That means, for example, generating new or additional clinical data to support registration, to support guidelines, to gain interest from partners. That can be, for example, application validation work that we do for our customers, for example, to get our analytes on a new platform or instrument. That all is also actually included in the total R&D spend. In addition, there's the capitalized development expenses per quarter. We hope this opens up and explains a little bit better the total number and how we use that money. Good news and exciting news. At the moment, we can't say more, like I said, about the collaboration project or about this technology investigation.
When we can, we obviously will give you an update. We are really excited about those. I conclude the presentation by talking a little bit about NT-proBNP and where we are now. About NT-proBNP, first of all, it is a biomarker that measuring it actually helps to support the diagnosis of heart failure. Our Gentian assay has two important features. First of all, it will be the first test of its kind available on high-throughput analyzers, so on clinical chemistry analyzers. As such, it should increase the productivity and reduce overall cost. Nobody else has been able to actually bring or convert this test from existing platforms to clinical chemistry. Secondly, the target molecule NT-proBNP actually is glycosylated. That means that there are sugar structures added to the peptide. That is unpredictable and individual and can change over time.
Existing assays actually use antibodies that bind to the areas where the glycosylation happens. The theory is, and there's more than theory actually behind it, that the glycosylation may interfere with the binding. Hence, these assays may not actually detect the total, the full NT-proBNP in the sample. In our case, actually, we selected antibodies that bind to areas that are not interfered by the glycosylation. This brings the promise that we can, first of all, measure the total NT-proBNP. That can have potentially clinical benefits in some underserved patient subgroups, like, for example, obese patients, which may be at the moment underdiagnosed. This has been a well-known fact, but because there hasn't been a real solution, it hasn't been so much in focus.
Now it's our job and the scientific community helping us and potentially some partners to prove that clinically this also is a benefit to patients and the doctor. Where are we at the moment? As you remember, last time we updated you about the important strategic decision where we chose really to focus on the total NT-proBNP assay format. During the second quarter, we quickly jumped on and started to move this product or assay format forward. We completed further calibrator adjustments, and we used and measured clinical samples on three key clinical analyzer platforms. We are already testing and adapting and optimizing our tests on three different analyzers from three different partners. This refined calibration actually yielded enhanced precision at low analyte concentrations, which is important for the cutoffs and interpretation of the results. There were some instrument alignment challenges. They were resolved during Q2.
Also, very important is the stability of our reagents. Now we can say that the key reagents and calibrator components demonstrate long-term stability, both real-time and in accelerated testing. Again, a very important step towards getting the product ready for registration. As I said, we also signed a new contract and secured access to new and larger clinical patient cohorts that will support our regulatory strategy and submission. With the preparation of all this and the IBD dossier, which is progressing on schedule, the project overall remains well positioned to enter its final validation phase now in the second half of the year. We can confirm our previously communicated timelines that we aim to launch the product, which is ready for research use only, in the second half of the year. We are aiming, depending on the regulatory timelines, for commercial launch, IBDR launch in 2026.
All in all, after the key decision, we have done the job required, and we are moving on as planned to launch this important product. To summarize this quarter, as you saw, actually, all the other products or product groups, except that fCAL, had an extremely good top-line performance. Quarterly, we had a second very strong quarter for this year. Overall, our EBITDA and gross margin are still on a nice level, although these hiccups that happened in April, May, as Njaal explained. Importantly, and I just want to restate that one, they seem to be one of, they happen once in a while. Of course, we try to improve and avoid those in the future, but that's not something we expect or should impact our coming quarters. Overall, we are on track, growing our business and meeting our and hopefully also your expectations.
With this one, that was all we planned to present to you. Now it's time to check any questions.
All right. I'll try to moderate. There's not a lot of questions in here. This is the opportunity to use the questions box in the application to post questions if you have any. We have a little bit of questions here. I think we can circle back to the U.S., Matti. With the growth that we now are seeing, I would say with two people, it's rather a successful venture over there. How do we think about further, let's say, additions or growth in the U.S.? Could you give some flavor on that?
Yes, the results look good. At the moment, we have been able to fulfill the needs of our partners. We are discussing actually already adding potentially one headcount for more technical sales, helping to adapt and get the labs started with our assay so that our salespeople, business development people, could really focus on finding new customers and closing the deals. Slowly, not too quickly, it looks like we can grow our presence there. I want to reiterate the importance of improved collaboration with our partners. There have been already certain steps we have taken together that have made the collaboration much more efficient. That is something we should do first. In a couple of weeks' time, in the ADLM Congress, we are having discussions with these partners of how to further improve our collaboration and how to potentially actually carbon copy that model to Europe as well.
All right. Thank you. Coming a question in there on, let's say, the performance issues that we have had in the production during the quarter. The first one is more when we became aware of the situation and what steps we took to understand and resolve the situation. The production issues themselves, you become aware of quite quickly. I'll answer to this as I'm also quite involved in the production here. The financial consequences take a little bit longer time to estimate and understand. Of course, when you have production issues, you try to, let's say, solve the production issues so that you have a sellable product. That is the first thing you do. You try to work and rework. It is the, let's say, ultimate decision is when you have to scrap. That comes quite late in that troubleshooting process.
The second question is, why did the problem last for so long, April, May? It's, in fact, in our process, it's not that is not particularly long to make a lot from start to finish. Our product can take up to three months. 2/3 of that time being then in a problem, and this relates primarily to one product. All the other products have run well. That is basically the explanation here. The third one is, is Matti sighted at the Gentian facility? Today you are in Moss, Matti. Normally, we tend to see her a lot around the office as well.
I have been most of the time, actually, here in Moss. I have an apartment here. Of course, due to family reasons, I try to spend some weekends and time back in Finland also. I'm present as much as needed. I think what we could also, maybe you could say some words about the robustness of production and the scale and control project we are running, in order to make everything more scalable and robust going forward.
As a growth company, we always try to be one or two steps ahead of the actual development. One of the items we are looking at, and we call that scale and control, is to look at, with increasing volumes, what kind of changes we need to do to our production setup and our production processes. That is an ongoing program. This is not what has caused issues, we believe, this time around. Sometimes when you do changes, scale up in production, you might get also production issues. That's not what we think so far has caused the problems we had last quarter. It's more related to quality issues on raw materials. I have another question coming in here. It relates to the dividend policy. Obviously, you have noticed that we paid dividends for the first time in May this year. The question is regarding the dividend policy.
We stated the dividend policy in our annual report. Being in the situation where we are, with being a growth company, being at the early stages on cash flow generation, it's quite a flexible type dividend policy. It says that we seek to pay annual dividends depending on the financial capacity and financing need to support future growth. When we speak about financing needs to support future growth, please remember we are an innovative company. There are a lot of ideas passing through this company continuously. Some of those ideas may turn out to be profitable, and then we will invest in them. This would always be a trade-off between the cash generated and the need to finance growth projects. That was a decent answer to that. We have no other questions on the list for the moment. No?
It's time to wish you all, at least from my side, a good summer. I will let Matti round off.
Yes, thank you. Thank you, Njaal, for presenting and helping us here and me. This concludes the quarter two 2025 Gentian presentation. We wish you all a very nice and especially Nordics finally warm summer, hopefully. We will see you again when we present our Q3 results later this year. Thank you and goodbye.