Gentian Diagnostics ASA (GENT) Q4 FY2025 Earnings Call Transcript & Summary

Welcome to Gentian Diagnostics Quarter 4 2025 Presentation. My name is Matti Heinonen, and I'm the CEO of the company. Today, let's go directly first to the highlights of the quarter and full year results, after which I will give you a quick update again about Gentian and what we do, who we are, followed by a presentation of key financials and product news and R&D presented by my colleagues. So last quarter of the year was a really good one for us with record high quarterly sales ever with continuously improving profitability. Some financial milestones. We reached sales of NOK 46.6 million, which was 9% growth or 12% organic growth compared to the previous year, which again was actually a very strong quarter in '24. Our sales to the U.S. continued very strong, and we recorded NOK 7.7 million in that quarter alone, almost doubling the sales from the previous year. Our EBITDA landed at 10.5% and again up from the quarter in the previous year. Gross margin went up 2 percentage points at 58%. So very strong both top and bottom line performance. Some additional highlights I want to mention. First of all, Cystatin C continues to be the growth driver. And we are happy to tell you that the sales did not only go well in the U.S. as they have, but also we had a very good quarter and eventually a year also for Asia and specifically China, which we were a little bit cautious about. Then some unfortunate news. Some very recent testing shows that the current assay of NT-proBNP does not perform reliably enough in the lower measurement range. This is obviously disappointing news and a setback for our timelines and development. And we initiated immediately activities to investigate whether redesigning the assay could improve the robustness. We will communicate any initial results when available, and we expect to present revised development and launch timelines during the second quarter of this year. On the positive note, we announced a new partnership with a top IVD company. We signed exclusive partnership for a test that we are developing for them and we'll also be the producer of the test. And this test will be added into one of the world's most widely used clinical chemistry platforms. And we are aiming together to have commercial launch of the test already next year. Then let's go to the full year '25 numbers. So I can summarize the year with a very solid top line growth with strong sales expansion in the U.S. and great profitability. Sales landed at NOK 176.5 million, which is equal to 16% growth over the '24 or 17% organic growth. Sales to the U.S. reached almost NOK 30 million, which is a very impressive growth over the '24 numbers. EBITDA, we grew almost NOK 10 million and landing at NOK 34.6 million. Gross margin, again, improved by 2 points. And for the full year, the number is 56%, and we are already in a good position with our longer-term gross margin target. Then again, some additional highlights. I want to once more emphasize the profitable growth, that we were able to grow the bottom line more than double compared to the top line, which was again a very good growth compared to industry averages. Sales of Cystatin C grew 32% during last year and driven by that sustained growth in the U.S. that we have seen in every quarter. And we have a very optimistic outlook also for '26. And also, like I said, better-than-expected performance in China despite the local cost containment measures. Adjusted sales increase in the U.S. was almost 50%. And as you remember, we have mentioned a couple of times about a warehouse shift from Europe to the U.S. That will still impact some months of this year before we can have apples-to-apples comparison of the sales growth. But this adjusted is exactly taking that into account, and very impressive growth that we are proud about. And that is actually due to our partner activities. We have very good collaboration and improving collaboration even with them. We have done our own direct investments that are paying off. And there is a clear momentum for Cystatin C in the U.S. now and going forward. Sales of our second biggest product, fCAL turbo, decreased by 1% last year. And the key reason was a very high quarter 4 in 2024 with stocking happening before announced price increases. On the other hand, during the second half of the year, the sales returned to expected levels. And again, we have a positive outlook for fCAL growth in 2026. Last but not least, as you remember, last year, Gentian paid dividends for the first time in its history. And for this year, for last year performance, our Board proposes a dividend of NOK 0.6 per share, which is 50% up from the previous year level. And this is due to the solid cash position, sound underlying earnings. And I want to also emphasize that, that doesn't compromise in any way of our growth investments and R&D efforts. So we come back to all these in more details soon. But here, a quick recap for those of you who are not that familiar with Gentian. So this is our mission statement: bringing efficient diagnostics for better treatment decisions. In a nutshell, as you see, the sales growth CAGR, 23% over the last years, which is really impressive, and we are really proud of that. And at the same time, we are doing that profitably. We are targeting a quite large segment of the diagnostic market, USD 2.2 billion, typically growing between 5% to 10% over the years. We work through appealing value proposition, lean business model and focused growth strategy. We have industry-leading capabilities in-house holistically, and especially we have a strong focus on R&D and operations. Well, obviously, you've already seen again our last year results. So we are growing profitably. And very important is the focus and the success that is rooted on high-quality standards and ESG. Shortly, what we do. Despite all the advancements in this industry, there are still many clinically relevant diagnostic biomarkers that are only available on slow and inefficient platforms. So by leveraging so-called open channel instrumentation, on the picture on the left, the bottom side, we use our expertise with PETIA technology to convert these manual or less automated tests for these high-throughput platforms. That means we don't need and we don't have our own instrumentation service or software. So we are using other companies' open channel instrumentation, like I said. And this is that very lean and cost-efficient model. End result and appealing value proposition for our customers and their end users is faster results, which leads to better treatment decisions and up to 10x improved efficiency and cost savings. Our go-to-market model relies on 3 channels. We can do direct to end users, and we are actually increasing our focus there in Europe and also in the U.S. by selectively adding our own salespeople. Then we use distributors in selected markets. But our ultimate goal with every product is always to have one or several global or regional partnerships with the key players. We aim and are accelerating growth by strengthening the strategic partnerships with these leading IVD manufacturers. And how do we get and spot new product ideas? Here are some examples of that. First of all, we are always looking for new and upcoming diagnostic biomarkers. GCAL in our current portfolio is an example of those. In addition, we spot or we are told and approached by these companies when they have gaps in their portfolio and they want us to develop and produce a product for them. And this undisclosed partnership I just talked about is, again, a good example of that kind of growth opportunity. Sometimes these players have quality, supply or regulatory compliance issues with their existing partners. And then again, they come to Gentian and asking whether we could replace their partner or supplier or develop a test for them. And we have recent approaches like this as well. And then there's always the price pressure coming from the payers and reimbursement systems and insurances globally. How do we differentiate from competition? I already mentioned the world-class R&D and operations, but we also provide throughout the product life cycle technical and clinical data generation and regulatory and product support. So we are truly a holistic, through-the-life-cycle partner for our customers. We operate on these key disease areas: inflammation, infection, kidney disease and heart failure. You see the established products from left to right. Cystatin C, launched in 2006, is our biggest product for kidney diseases. fCAL is the fecal calprotectin for inflammation in the bowel. fPELA is a coupling product for fCAL. And these 2 products, as you know, are exclusively commercialized by BUHLMANN Laboratories in Switzerland, our long-term partner. Then we have dog or Canine CRP, which is a gold standard in that area. And we have a new business or in a market development product also, RBP, retinal binding protein. GCAL was launched in 2019. It is the same infection inflammation marker as in fCAL, but this is Gentian product and it's used for serum and plasma samples. Our main focus there is inflammatory rheumatic diseases, and we are investigating also sepsis and other infectious diseases area to find appealing customer value propositions. And then I'll come back later to NT-proBNP, which is our heart failure development project. And lastly, here, you can see our strategic growth drivers for long term. We have 5 established products with solid growth potential. And especially again, I want to emphasize Cystatin C, where we have this accelerate Cystatin C initiative and increased investments especially in the U.S. We work to prove the clinical relevance of GCAL asset and we do our best to bring NT-proBNP to the market. We want to bring a steady stream of new, high-impact diagnostics tests to the market. We are just about to decide our next actually R&D project. And I can tell you that we have a good shortlist of other opportunities as well, which we are discussing with our owners and Board what to do with them. Overall, our aim is to accelerate the product introductions to the market over the next few years. We want to secure at least one new contract with a global player per year. We want to bring the gross margin closer to the 60%. And as you saw, quarter 4 was already at 58% and full year, 56%, so we are approaching that target nicely, and to have long-term EBITDA margins of 40%. With this one, I invite my CFO, Njaal Kind, to take the stage and go through the key financials. And I'll be back later for the R&D update. Njaal?

All right. Thank you, Matti. Good morning. So this morning, we announced a new record sales of NOK 46.6 million for the quarter and NOK 176.5 million for 2025. The sales performance geographically is mainly driven by very positive developments in the U.S. and also Asia, which has normalized after a weak 2024. The U.S., there is an adjustment factor there, but the adjusted sales growth is 48% for 2025. So very, very strong sales performance. And in addition, we had one customer shifting its warehouse from Europe to the U.S., which adds another NOK 11 million. But that comes out of the European sales. So European sales looks down but, in fact, adjusting there as well, it is, in fact, up 8% for the year. Looking at products. Quite strong performance on all of the products except fCAL. We have our main product, Cystatin C, up 22% for the quarter and 32% for the year. NOK 67 million of revenues for the year as a whole on that product. fCAL turbo, I would say, a marginal decline both on the quarter and for the year as a whole. It's important to emphasize that we have not been informed or seen any changes to the market. But sometimes growth is not linear. So here, it's clearly a breather. And we expect the market and the sales of fCAL turbo to come back. Third-party products, which is our Nordic distribution business, continues to do well. Booking revenues NOK 21.2 million for the year and NOK 6.4 million for the quarter, which is a solid improvement compared to last year. And in the Other category, that's where we have all the smaller products. We still see quite good growth, 27% for the year as a whole. Shifting to cost, to the OpEx. As a growth company, we do add a little bit of OpEx but not close to the increase in sales. So this is one of the parameters where we claim that we have profitable growth. We see that the OpEx increases by 8%, and that's comparing to an organic sales increase of 17% for the year. And there are some smaller variations from quarter-to-quarter, but all in all, our OpEx is quite stable. Also note, we capitalize some of the R&D expenses. So that's just over NOK 4 million in the fourth quarter. Looking at the gross margin, 58% for the fourth quarter and 56% total. The year as a whole was a little bit influenced by some production issues in quarter 2. We are very happy to see that the operations team solved those issues swiftly, and we returned to solid gross margins quickly in Q3 and Q4. Our previous communication, which we still stick to, is that on these revenue levels, we are aiming for a gross margin in the 55% to 60% area. EBITDA. For the fourth quarter, we reported an EBITDA of NOK 10.5 million. And when we add up the previous quarters, the EBITDA for the year is NOK 34.6 million. That is an increase of 40% compared to last year. Looking at the EBITDA margin, it's at 19.6%. And our long-term ambition, which is 40%, but keep in mind that, that is something we aim to achieve on a significantly higher revenue base than what we have now. Looking at some of the balance sheet numbers. We can start with the cash. NOK 105.9 million of cash as of December 31. That's an increase of almost NOK 21 million, and we can also then add on that we paid NOK 6.2 million in dividend during the year. So a very strong cash development. A word of caution. We had a very good or positive impact on working capital movements in Q4, and we expect that to normalize during Q1 and Q2 this year. So it's a very high cash number, but overall, we are satisfied with that. For 2025, the Board will propose to the General Meeting to pay NOK 0.60 per share, which is up from NOK 0.40 last year. All the other parameters here, small movements. We still have no interest-bearing debt and we have an equity ratio of close to 80%. I think that wraps it up for me. Happy to be back in the Q&A if there are any questions to the numbers. But yes, I think I will leave it to now Markus to take us through more detail and comments on the different products. Yes. Markus?

Thank you so much, Njaal. My name is Markus Jaquemar. I'm the CGO of the company, and I'm trying to add a little bit more flavor on product by product as far as our performance in '25 is concerned. And as you've heard before, exceptional performance of our largest product, Cystatin C, where we enjoyed 32% growth over the year, which actually ends up at NOK 67 million, up NOK 16.4 million versus prior year. What you see on the product slides actually to the left side, you see the quarterly performance over the last 2 years, which kind of supports the comments on the product performance. And coming back to Cystatin C, already mentioned, strong robust U.S. performance and China stabilization which contributed to the growth. In the U.S. alone, we've added 36 new customers. And at the same time, collaboration with our U.S. partners drove really the growth of 87% in the fourth quarter and 146% during the entire year for the U.S., which needs to be adjusted, as Njaal mentioned, due to the warehouse change. But still, 48% growth in the U.S. We're very happy to see the stabilization of the business in China with all the impacts of the value-based procurement and unbundling initiatives that China implemented. Carefully watching what's happening. We do see that the major impact has actually happened, and we see the business to continue on a more stable level. But we continue to watch it. Important to mention that, obviously, based on the great results for Cystatin C, we have decided to keep investing in the product from an infrastructure perspective but also additional activities with our partners now but also going forward into 2026. And some reasons and some background to that. We have initiated what we call the accelerate Cystatin C plan. And that's not only a genuine internal Gentian initiative, but we actually execute it together with our partners especially in the U.S. And when we look at the potential for Cystatin C just for the U.S. Currently, only 7% of the U.S. hospitals, there's about 6,500 hospitals in the U.S., are requesting Cystatin C to be run in combination with creatinine, which is the traditional parameter used for kidney disease or CKD, chronic kidney disease, testing. So there's obviously a large potential right there. What's driving the growth? There is a new guideline by KDIGO, which is a global institution regarding kidney diseases. And they recommend a new parameter and new algorithm where creatinine and Cystatin C are used in combination. That's really driving the adoption within the laboratories. And when we look at our market potential through our own presence but also through our partners in the U.S., we can actually address 30% of the clinical chemistry market in the U.S. And as such, there's clearly a great opportunity for future growth for Cystatin C. So forward-looking, very positive. Let's look at our second product, fCAL turbo, which is commercialized with our long-term partner, BUHLMANN Laboratories, from Switzerland. And as Matti has already mentioned, we're back to growth in the second half in 2025. Again, if you see the quarterly performance, we had a dip Q1, Q2. Already mentioned, there was some unusual stock building at the end of '24, but that's normalizing now with a great performance in the fourth quarter. And so overall, we have a flat business in '25 but the outlook is positive. Overall numbers, NOK 60 million for the product in '25. For '26, looking forward. BUHLMANN has announced 2 partnerships with major IVD companies, which is Beckman Coulter and also QuidelOrtho. And the impact of that is expected to be seen in '26, not yet in '25. These organizations do take a bit of time to fully accelerate the commercialization of a new product. But definitely very, very positive looking forward. Other Products. Njaal has already mentioned the Other Products category. That includes our Canine CRP product, which is, as Matti mentioned, the golden standard in veterinary testing already. It's the pancreatic elastase which is also commercialized through BUHLMANN Industries, and it also includes our serum plasma calprotectin, GCAL. Very nice growth for our GCAL product in the fourth quarter, even though overall, GCAL has still a moderate sales level but with potential to grow further. Between all 3 products, we have ended our sales at already NOK 27.7 million, which represents 27% growth over 2024. So very optimistic also for the development of the Other Products category overall. Third-party products, other products commercialized by our Gentian AB subsidiary. And very, very strong performance in the fourth quarter, to a record level, at the same level as we had in the second quarter of NOK 6.4 million. What's the background to that? It's a combination of adding new customers. But what's also very important is increasing the testing volume at existing customer sites, which is a very profitable way of growing growth, in fact. We had seen a dip if you look at the quarterly performance in Q3. A bit unusual this year, even though as we are here really in the direct sales mode. We see the impact of the summer months overall. But if you look at the entire performance for the year 2025, we have seen 16% growth. And in the organization driven by Aleksandra Havelka as the General Manager, we continue to execute on product portfolio expansion as well as regional expansion within additional territories in the Nordics. With that, I'll turn it over to Matti to give an update on R&D. Thank you.

Thank you, Markus and Njaal. And yes, before I go to R&D, a reminder, please use the Q&A function if you have questions. And we will come back to those after this update. So again, during last quarter of '25, we announced this exclusive cooperation agreement with one of the leading global diagnostic companies. And again, so we are developing a novel assay that is a gap in their portfolio. It is an existing market with an existing partner and it will be integrated, like I said, in one of their clinical chemistry platforms. And if all goes well with the development and regulatory timelines, we are targeting together a commercial launch during the second half of next year. And again, I want to repeat. When we think about our product pipeline and development, we want, going forward, balance more this type of faster to sales with the partner projects with de novo developments, where typically the time to market development takes longer. But we're not becoming only a contract partner. We will still be an innovative company looking for also those big opportunities. Another very interesting thing we are working on is something we call this high-sensitivity technology. We have mentioned this a couple of times now already. And during the last quarter, we used our prototype that we have built that is used by our research unit in Gothenburg. We did more evaluations of the sensitivity of that instrument and that technology actually. And we do see significant sensitivity gains with that technology, and that has a potential for meaningful differentiation compared to existing clean chem instruments and technologies. And while we are doing this, a couple of more words about it. By increasing the sensitivity, we made an estimation that we could be able to bring around 100 new analytes within the reach of clinical chemistry and PETIA technology, which would be really a game changer in this area because we or our partners could be able to bring markers that are at the moment not reachable sensitivity-wise. During this year, we are building a package of data for this high-sensitivity technology. And with that appealing package, hopefully, we are then planning and have started already to look for initial partners to discuss applying this technology on their instrumentation. And additionally, I want to mention that based on our current understanding, this should be applicable both for central lab clean chem instruments as well as [ immuno-tool ] parametric point-of-care platforms. So there are many, many opportunities with this one, and we keep working on it and keep you updated. Outside of this, I already mentioned the other development projects. So we are getting ready to kick off our next project mid- this year roughly, pending a little bit the NT-proBNP investigations and resources needed. And we will then inform more about those. And on the right-hand side, you can see the R&D spend quarterly and year-over-year comparison and breakdown. And the key message here is that we have kept our investments stable and that is also our aim. But obviously, we want to increase the return on these investments going forward. And then lastly, a little bit more about the disappointing news on NT-proBNP. So NT-proBNP, as you may know, is a cornerstone test in heart failure diagnostics. It is roughly a $1 billion market out there dominated by Roche and other key players. There are no NT-proBNP assays on clinical chemistry platform today. So Gentian, we are the first one who have gone this far developing the test. So I just want to emphasize that we have been and are all the time operating on the limits of the sensitivity of PETIA. In addition, there are some other gaps and unmet needs in that test related to the glycosylation of the target molecule that our assay could be able to overcome. But then, like I said, in our recent verification studies, we met some issues. We were not able to finalize all the studies, as we informed just before Christmas. And now with very recent investigations, they show that the current assay version does not demonstrate sufficiently robust performance in the lowest concentration ranges, which are still important because of the cutoff levels in that area. So we have initiated immediately activities to investigate whether redesigning the assay format could help. And like I said, we will share any findings as soon as they are available. At this stage, we are not able to provide an updated timeline for the research use-only product availability nor for the subsequent commercial launch of the product. And we are planning to come back to you and the market during the second quarter of the year with this update. So like I said, this is a setback for the development but it's not the end of it. And we are still working heavily to solve the issues. With this one, we are done with our presentation. And if there are any questions posted? None at the moment. So then I want to summarize. And thank you all first for joining, my colleagues for presenting and helping to put together again the numbers. So we had, as you saw, a very strong quarter and year, growing top line multiple times compared to the benchmarks and market and more than double pace growing our bottom line. We are advancing many R&D projects despite the NT-proBNP setback. We are about to start a new development project this year. We are strengthening our partnerships with the key players and expanding also as we can. And then we are very positive about the Cystatin C opportunity. We are investing in that especially in the U.S., and happy to see the China stabilization. And also we had a good and close collaboration with BUHLMANN Laboratories and also good positive feelings about the 2026 performance based on our discussions. So all in all, we expect to continue the profitable growth and investing in innovation, in R&D and to bring more products to the market in coming years. With this, thank you once more, and have a very nice Wednesday.