Earnings call transcript: Gentian Diagnostics sees 28% sales growth in Q3 2025

Gentian Diagnostics reported a strong third quarter in 2025, with sales rising 28% year-over-year to NOK 41.8 million. The company’s EBITDA also saw a significant increase, up 46% compared to the previous year. With a market capitalization of $59.73 million, the stock remained unchanged at NOK 55. According to InvestingPro analysis, the company trades at relatively high EBIT and EBITDA multiples, suggesting premium valuation. The stock has shown low price volatility, with a modest 6.44% year-to-date return.

Key Takeaways

• Sales grew by 28% year-over-year in Q3 2025.
• EBITDA increased by 46% compared to the previous year.
• The company added over 30 new customers in the U.S.
• Cystatin C product line saw a 73% growth in the quarter.
• Cash position improved by NOK 6.3 million since the start of the year.

Company Performance

Gentian Diagnostics demonstrated robust growth in Q3 2025, with sales reaching NOK 41.8 million, marking a 28% increase from the same period last year. The company’s focus on expanding its customer base in the U.S. contributed to this growth, with over 30 new accounts added. The Cystatin C product line was a standout performer, achieving a 73% growth in the quarter, reflecting strong demand and successful market penetration.

Financial Highlights

• Revenue: NOK 41.8 million, up 28% year-over-year
• EBITDA: NOK 24.1 million, up 46% year-over-year
• Gross Margin: 56%, up 4 percentage points year-over-year
• Cash Position: NOK 86.6 million, up NOK 6.3 million from year start

Outlook & Guidance

Gentian Diagnostics remains focused on expanding its presence in the U.S. market, with plans to launch a research-use-only NT-proBNP assay by the end of the year. The company is also preparing for a commercial launch of this product in Q4 2026. However, the company expressed caution regarding the Chinese market due to a new "unbundling" initiative, which could impact growth prospects in the region.

Executive Commentary

"Our success is rooted in high-quality standards and ESG," said Matti Heinonen, CEO. CFO Njaal Kind added, "We aim to grow revenue faster than we grow OpEx," highlighting the company’s focus on efficient growth. Markus Jaquemar, Executive, noted, "Less than 10% of the U.S. hospitals have adopted Cystatin C testing," indicating significant growth potential in the U.S. market.

Risks and Challenges

• The new "unbundling" initiative in China poses potential market challenges.
• Limited adoption of Cystatin C testing in U.S. hospitals could slow growth.
• The company faces competition in the $2.2 billion diagnostic market segment.
• Economic fluctuations and regulatory changes could impact international operations.

Q&A

During the earnings call, analysts inquired about the potential impact of the "unbundling" initiative in China and the adoption rate of Cystatin C testing in the U.S. Gentian Diagnostics responded with confidence in stable performance in China, although not expecting major growth, and highlighted the untapped potential in the U.S. market given the current low adoption rates.

Full transcript - Gentian Diagnostics AS (GENT) Q3 2025:

Matti Heinonen, CEO, Gentian Diagnostics: Very good October morning from us. My name is Matti Heinonen and I’m the CEO for Gentian Diagnostics. I have the pleasure today with my colleagues Njaal Kind and Markus Jaquemar to present Gentian’s third quarter 2025 results. Again, this quarter, our employees and all of us, we have strived to bring more efficient diagnostics to have better treatment decisions for patients. This is our mission statement. As most of you are well aware, Gentian Diagnostics is a medtech company that is targeting a $2.2 billion segment of the diagnostic market with quite high 5% to 10% annual growth. I will quickly walk through our value proposition, business model, and strategy, and also why we are a competitive and appealing partner for our customers. As you can see from the left-hand side, we are a company at the commercial phase.

Today you will hear more about the quarter three and year-to-date results. Obviously, as this industry is really critical, our success is rooted on high-quality standards and ESG. What we do at Gentian is that we are looking for upcoming or large high-volume biomarkers that are still used on manual or semi-automated platforms. Our expertise lies in converting these tests to high-throughput analyzers. As you can see on the left-hand side, down the picture on the down of the slide, sorry, where you can see a clinical chemistry automation line. We do this by leveraging so-called open-channel instrumentation. We don’t need and we don’t have any instruments or software of our own, but we use existing IVD companies’ platforms. The end result and that appealing value proposition is faster results, which can lead to better treatment decisions and up to 10 times improved efficiency and cost savings.

We operate through a lean business model and we rely on a selection of go-to-market channels. We use one or a selection of these based on a product, its life cycle, market competition, and so forth. Longer term and for global reach, we always typically aim to have a partnership with one of the global IVD players. How do we execute our existing strategy and how do we find new ideas for product development? We are and aim to be an even stronger strategic partner for our customers. We are continuously looking and scanning the market, both scientifically and with the customers and end users to spot new and upcoming diagnostic biomarkers. In addition, when we have dialogue with our customers, we find out gaps in their portfolios and we can develop tests to fill those gaps.

Also, sometimes, and again quite recently, we can get a call saying that a customer may have issues with their current third-party suppliers regarding quality, supply reliability, or, for example, ability to live up to the regulatory compliance. They can ask us to make a new assay for them. Of course, overall, there’s continued price pressure as an unmet need, which we can address with our value proposition. How we differentiate from competition is that we don’t only produce these products, although we have world-class in-house R&D and flexible, scalable kit or bulk production, but we also provide technical and clinical data generation and regulatory and product support to our customers. At the moment, we operate in these disease areas: inflammation and infection, kidney disease, and heart failure. Cystatin C is our biggest product at the moment, and it is used for diagnostic of kidney disease.

It was launched already in 2006, and we are one of the leading companies providing this test in the world. We have two tests for fecal testing. fCAL turbo is an inflammation test for bowel conditions, and it is accompanied by a pancreas deficiency test, fPELA. We have one product for vet diagnostics, canine CRP for dogs. We have a product called RBP, which is used for kidney disease and malnutrition diagnostics. In market development, we have another calprotectin assay called GCAL, and unlike the fPELA, fCAL turbo, excuse me, is for fecal testing. GCAL is for serum and plasma samples, and it’s used to diagnose inflammation and infection in multiple conditions. Today, a little bit later, I will talk more about our late-stage development assay, NT-proBNP assay, which is a heart failure biomarker.

Here you can see some key drivers for our long-term growth and also some longer-term financial aspirational targets. With this, let’s go and look at the highlights of the Q3 2025. This quarter can be described as both strong top-line and bottom-line performance, and that was especially driven by high growth in the U.S. From last quarter, the gross margin is back on normal levels and back on track. Our sales in third quarter were NOK 41.8 million, which is up 28% compared to last year. Our sales to the U.S. were NOK 1.8 million compared to NOK 2.4 million last year. EBITDA, we recorded at NOK 4.8 million, again up from NOK 5 million last year, the same period, and gross margin up from 52% to 56%. Some additional highlights, and again, we will deep dive into these later in the presentation.

Year-to-date, our sales are almost NOK 130 million, which is up 19% versus last year, first three quarters. EBITDA at NOK 24.1 million for the first nine months versus NOK 16.5 million last year. Sales of Cystatin C, it has been performing really well the whole year, and Q3 was not an exception. We grew 73% compared to last year’s same quarter, driven by great performance in the U.S., but also recovery in China compared to last year. Overall, when we look at the U.S. sales, year-to-date, we have sold there NOK 21.7 million compared to NOK 8.1 million last year. It’s worth noting that one of our customers made earlier this year a warehouse shift from Europe to the U.S., and year-to-date, this impact is NOK 8.3 million. Even taking that into account, the adjusted growth rate for the U.S. business is 165%.

What is also really pleasing to see is that already 10% of this year’s sales are coming from accounts acquired this year only. We start to see really the result of new accounts added, as we have communicated previously, and this is obviously something we will keep doing and striving for. If we look at some other highlights, our heart failure assay NT-proBNP is moving closer to the final stages of verification and getting ready for having the RUA, research-use-only product launch, by the end of this year, and we are targeting a commercial launch in the fourth quarter next year. We have a development project undisclosed at the moment for a major IVD company, and that also entered successfully the next development phase, moving from proof of concept to optimization. That was an important milestone in our R&D.

When we look at our clinical data generation, a study called GEOCOMPAS, which is investigating the children for rheumatoid arthritis, it has activated several sites, and already approximately 70 patients are enrolled in this study. The study is evaluating the diagnostic and prognostic use of GCAL in this patient population. With this opening, I hand over to our CFO, Njaal Kind, and he will walk through some of the financial highlights.

Njaal Kind, CFO, Gentian Diagnostics: Yeah. Thank you, Matti. Good morning. I will take you through the P&L and some of the financial information. This morning, we announced the sales of NOK 41.8 million, year-to-date sales of NOK 129.9 million. If we look at the geographic breakdown of the sales, the U.S. sticks out in a positive sense where we have NOK 10.8 million of sales compared to NOK 2.4 million in the corresponding quarter last year. There is an adjustment factor here. We had one customer shifting its stock from Europe to the U.S. If we adjust for that, the sales would be NOK 5.4 million in the U.S. in the third quarter. That corresponds to a growth of 125%. Year-to-date, also making that adjustment, we are about 165% up in the U.S. Very positive development in that region.

In Europe, sales look flat, but there we also need to make this adjustment for that stock move. We have 18% growth in Europe on the quarter and 9% growth year-to-date. Asia, NOK 4.2 million versus NOK 3 million last year. It’s still below where we wanted. We can come back to that in the discussion later on. Looking at the product level, we see very strong performance for Cystatin C this quarter and also year-to-date. The growth on the quarter is 72%, and we are up 36% on sales compared to where we were year-to-date compared to last year. fCAL turbo had a bit of a soft start of the year, but in the third quarter, sales came in at NOK 15.9 million, which is up by 11% compared to the same quarter last year. We are now on par with the sales year-to-date compared to last year.

Third-party products had a soft quarter. Here, we do see a lot of quarterly variations. Year-to-date, sales are up about 10%. In the other category, we have grouped the products that are not big at the moment. Here we have fPELA, GCAL, cCRP. These products are also growing nicely, 28% up on the quarter and 19% up year-to-date. Shifting to the cost, quite stable cost development when we see over time. If we look at the year-to-date cost development, we are about NOK 5 million higher in OpEx compared to where we were at the same period or the first nine months last year. Remember that we are a growth company, so we have added about NOK 20 million of revenue. In order to sustain that, we needed to add about NOK 5 million of cost.

I think it’s a fair assumption to say that we will continue to grow the OpEx as long as we also grow the revenue. Our ambition is obviously to grow revenue faster than we grow the OpEx. Overall, this is a well-managed OpEx evolution and needs to be seen in light of the revenue growth that we are experiencing. Gross margin, we say back on track. We believe that on the current revenue level, our gross margin should be in the 55% to 60% area. This quarter, we are at 56%, and this is up from 44% in the second quarter this year where we experienced some production issues. Our operations team was quite quick in troubleshooting and fixing those issues, really. We are back on normal levels. That’s good to see. There is a strong correlation between the gross margin and the EBITDA margin. EBITDA margin is 20%.

Year-to-date, it’s about 18%. Looking at the EBITDA, we report an EBITDA of NOK 24.1 million year-to-date. That is approximately the same level as we had for 2024 as a whole. If we see the development a bit over time, we see that the company has gone from EBITDA losses to now a nice evolution on EBITDA positive growth. On the cash side, we have NOK 86.6 million in cash. That’s up NOK 6.3 million from the beginning of the year. In addition to that, please note that we paid NOK 6.2 million in dividends in Q2 2025. Underlying cash generation here is satisfactory. Just a reminder, we don’t have any interest-bearing debt. When looking at our working capital, we say that that should be about or will be about 30% of sales. I think that’s it from me. Happy to comment if there are any questions.

There should be a questions box or some question opportunity on this webcast. Please type in your questions if you have any, and I’ll be back with the Q&A. Now it’s Markus Jaquemar that will give you more details on the products. Markus.

Markus Jaquemar, Executive, Gentian Diagnostics: Thank you, Njaal. Very happy to provide a bit more depth regarding our products and the performance of those products over the last quarter and also year-to-date, actually. The winner, really, Cystatin C, it was mentioned before, great performance for Cystatin C, 73% growth and driven, or also mentioned by continued U.S. momentum. If we look at the quarterly graphic to the left, you see if we compare Q3 2025 to 2024, 2024 was a weak quarter. Still, if you look at the quarterly performance over the last three, four quarters, very nice performance at a very high level. Overall, year-to-date growth was 36%. Now, interesting to note is that we are actually already today at the level of Cystatin C sales for the full year 2024. I think that speaks for the success.

Matti has already mentioned that in the U.S., we have added quite a few customers, actually more than 30. Bringing customers to actually use the product in routine use is one of our major objectives. The team is doing an excellent job together with our partners that we have in the U.S., driving the growth here. Those NOK 2.3 million that come just from new customers this year is a very positive driver for our sales in the U.S. Another reason for the Q3 performance is that China business was at a reasonable level in the third quarter this year, whereas the impact a year ago from the value-based procurement procedures was seen significantly. It has come back. I’ll comment back on China a little later. This was also definitely a positive driver for overall Cystatin C sales in the third quarter and for overall the year-to-date so far.

fCAL turbo, our second largest product through our partner Buhlmann. As Njaal mentioned, we have 11% growth from quarter to quarter. After two rather soft quarters earlier this year, we have come back to actually the second highest quarter we’ve seen so far for that product through sales to essentially all regions, growing sales to all regions that Buhlmann serves. Establishing high sales at a high level, right, is definitely contributing to our nice growth overall. Even if we say that for the year, we have seen just 1% growth, the momentum in Q3 is definitely positive. Other products, as Njaal mentioned, they include our canine CRP product for inflammation detection in canines or dogs, the pancreatic elastase product, and GCAL. What you see quarter by quarter is really a very nice stable development over the last actually year and longer. We grew 37% for that category.

With year-to-date sales ending at $21 million, almost equally at 34% growth versus 2024. What’s nice to see is that fPELA and cCRP are both delivering clearly above the company’s average growth, while GCAL is below our expectations, but is even growing in the category itself. Third-party products, yes, it was a soft quarter, but if you look at the quarterly performance, we had a very, very strong quarter in Q2. This needs to be balanced. The reason for the third quarter lower sales is definitely not based on lower demand, but it’s really phasing of customer orders and really seasonal variances. What is important to note is here, we’re growing 9% overall still for the year, but we’re implementing important initiatives here. One is regional expansion towards Denmark, but also to Finland.

Additionally, the organization is adding additional products to expand the portfolio to serve our customers with more products. If we look at the regional distribution, as Njaal has mentioned already, one important shift happened earlier this year that one of our customers has shifted the warehouse from Europe to the U.S. That now reflects in more reality the regional sales in the U.S. overall. The impact was quite significant, as Njaal mentioned, $8.3 million for the year. Even without that warehouse shift, we see very, very strong momentum in the U.S., as already mentioned a few times, with the adjusted growth rate of 165%. Asia comment on here, we have talked about China a few times, and the recently implemented initiatives like the value-based procurement system was also impacting the sales, especially last year in Q3.

There’s an additional new initiative by the Chinese administration, which is unbundling in order to manage cost in the diagnostic testing segment. That is called unbundling, by which rather than using a full menu to test patients, you more selectively use assays in patient testing. That may have an impact. We are cautious about the outlook from the Chinese business going forward. The pure numbers show that Europe declined 2%, but again, as mentioned, if we adjust for the $5 million, actually, Europe also grew nicely in the third quarter. Overall, we see growth in all regions that Gentian Diagnostics is serving. With that, I’d like to turn it over back to Matti.

Matti Heinonen, CEO, Gentian Diagnostics: Thank you, Markus. I put on now R&D hat and give you an update about Q3 R&D. Last time in July, we opened a little bit the curtain for a new early exploratory work we are doing, which is to test a new technology with the potential to significantly expand the sensitivity limits of current PETIA assays. This last quarter, we have continued that work. The focus has been especially on the technical evaluation, but also assessing the implementation feasibility of this technology if one’s ready for that. We have started some early market and commercial evaluations for the potential. This is really early and something very long-term project. We will keep you updated. I already discussed about the undisclosed project that moved from proof of concept to optimization. What was done with that is that now it’s being tested on multiple clinical analyzers.

We are also improving the reagent formulations for that assay. On the right-hand side, you can see the R&D spend. Overall, we are pretty much stable from last year, year to date. This is at least what we aim to do. We have no plans to cut down our spending. If something, rather up to develop faster and more assays. You can see the breakdown of these costs. In R&D cost, we have also the technical and clinical support for existing products included, as well as capitalized development expenses. A little bit more about NT-proBNP as promised. A quick refresh on what NT-proBNP is. It is a cornerstone test in heart failure diagnostics. As said, it’s a large market. It’s estimated to be $1 billion this year and growing approximately 7% over the next years.

What is still what is known is that this target molecule, NT-proBNP, up to 80% of that molecule can have sugar structures attached to it. That is called glycosylation. The unmet need and potential issue we are targeting to solve is that all current assays, they tend to underestimate the NT-proBNP levels due to their assays’ antibodies binding on those glycosylated areas. What we are doing at Gentian Diagnostics is that we are developing what we call glycosylation-independent NT-proBNP assay, aiming to improve both accuracy and consistency of heart failure diagnostics. What happened in third quarter was that we made, again, significant efforts advancing the project, moving it closer to the final phases of verification and getting ready to move to the last phase, which is called validation, before we are ready for the technical documentation and IVDR filing. Especially, we were working on the calibration model.

We refined our model, resulting in enhanced precision at the lower measuring range. This is important because it is needed to establish those cutoffs for our test to be used in patients. However, we are working with chemistry and biology, and not everything always goes as planned. We encountered some unforeseen challenges related to the calibrator stability. Now we talk about liquids with certain amounts, known amounts of NT-proBNP molecule there that is used to calibrate the instruments. We saw some instability issues with these current or previous matrices used for the calibrators. Our team worked really hard, and they have made already significant progress identifying improved matrix formulations, which are currently being tested for stability. In parallel, we have run, again, a new set of clinical samples from patient cohorts that come from our clinical partners and clinics, especially here in Norway.

That data, patient data, is now being evaluated against our measured values. All that data is important for the final development of the product, but also we are generating data for the IVDR filing with that already. To summarize and end, we are working to introduce the assay as a research-use-only product by the end of this year and also aiming for full commercial launch in Q4 2026, so next year. I’m sure we will keep you updated and come back next time with NT-proBNP again. This concludes our quarter three 2025 presentation. Now we open this meeting for questions. Remember to use the Q&A functionality in the webcast. I ask Njaal and Markus to join me here and to answer any questions up there.

Njaal Kind, CFO, Gentian Diagnostics: Yes. Am I in the picture now? Good. Let’s start off with China. There have been some developments, as you explained. We have experienced value-based pricing. Now we are about to experience something called unbundling. I think the question is, what is our expectation in general for China going forward? Also, how should we think about this unbundling, how it will unfold, etc.?

Matti Heinonen, CEO, Gentian Diagnostics: I can start with that one. I visited China a month ago and met our partner, Beckman Coulter China people there over a couple of days. They gave us a very good and thorough view of the situation. Overall, there’s kind of various performances. Beckman Coulter has been doing well. As you can see from our sales so far, the value-based procurement has been there already for a couple of years. We have had, except that weak quarter three last year, growing our stable sales. This unbundling initiative is a second initiative. I’m not sure if it’s going to be the last one.

Honestly, kind of the system in China is moving from what they used to have, I would say, more to a model that we have in Western countries, that you can’t automatically include a bunch of tests in a panel, but you have to do more really value-based argumentation and why a test should be used and taken for a patient. That is obviously meant to control the volumes. Through the discussions, what we mean by cautious is that we’re not necessarily putting a lot of growth expectations for our China business next year, but we don’t expect a major crash of the business either. We have a good model with them and communication channel open to help them to do the selling and value argumentation to keep Cystatin C growing longer term.

Markus Jaquemar, Executive, Gentian Diagnostics: Yeah, maybe to add to that, Cystatin C testing in China is already well established in the NGS. It is the standard marker for chronic kidney disease already. That means it’s well established. Even with the unbundling, it is just a standard test. That gives us obviously some positive outlook in that respect. Also to say that the impact of those value-based procurement initiatives was very much on high-value products, a lot in terms of pricing, whereas the number of testing hasn’t gone down as such. Overall, something to watch carefully. Yeah, I think the future will show us.

Njaal Kind, CFO, Gentian Diagnostics: Thank you. There’s also a question, we are sticking in Asia, and that is how much of the Asian revenue is derived from China, and how much is from other countries in Asia. The split is about 60/40. 60% of our revenues in Asia is from China, and the remaining 40% are from other Asian countries, especially South Korea.

Matti Heinonen, CEO, Gentian Diagnostics: I also visited South Korea on the same trip. Our partner, Anmi, is doing a really good job, and they are investing more and expanding their network in South Korea geographically. We expect that business to keep growing.

Njaal Kind, CFO, Gentian Diagnostics: All right. Thank you. Switching to the US, we have reported now over a few quarters good growth. It looks also to be accelerating a little bit. The question here is, do we expect this momentum to continue? Maybe you can say a little bit about what we are doing in the US, what is our model with partners, directs, etc.?

Markus Jaquemar, Executive, Gentian Diagnostics: First of all, the answer to the questions, do we expect future growth, is yes. Less than 10% of the U.S. hospitals have adopted actually Cystatin C testing so far, which means there’s a lot of opportunity and potential for further growth here. That is, I think, a very positive sign. Regarding our business model, we have a direct operation in the U.S. where we serve customers directly. We work with two corporate partners, one of them being Beckman Coulter, which is well known. The organization actually supports our partners also directly to support their customers. In combination with our direct efforts and supporting our business partners, we really, I would say, fuel the growth, including working closely with patient organizations so that we make the benefits of Cystatin C testing more visible and therefore supporting the adoption of Cystatin C testing in the U.S.

Matti Heinonen, CEO, Gentian Diagnostics: There is great momentum. We have already talked a couple of times about the updated guidelines that happened last year. Based on that and the whole more awareness of Cystatin C this summer in the major congress, ADLM, we heard updated numbers. The idea is that the market could be up to $400 million Cystatin C market alone in 5 to 10 years. There are certain requirements that have to happen to make that number come true, like with the reimbursement. Still, the potential is there. We are also, like Markus Jaquemar said, we have already improved and intensified our collaboration model with the partners. Also directly, we added one headcount last year. We are going through, again, a bottom-up analysis about future investment and headcount needs.

Obviously, with the China situation being what it is and this great momentum being in the US and hopefully landing also to Europe, that’s going to be the future growth area, at least for a couple of next years for Cystatin C.

Njaal Kind, CFO, Gentian Diagnostics: Can we say something about how our partners are looking at Cystatin C? What is their sort of take on the product? Maybe, you know, do they have some short-term expectations as to 2026, 2027, short to medium-term expectations there?

Markus Jaquemar, Executive, Gentian Diagnostics: I mean, from a partner perspective, we have to understand that Cystatin C is part of their overall menu. As such, our partners are looking to strengthen, I would say, kidney testing portfolio, which is very important with other assays like the mentioned creatinine that’s the standard, in combination with Cystatin C and other parameters. That provides them with a high-quality product, as it is actually proven by external quality control testing measures. They just have a high-value, high-quality product that they enjoy together with the rest of their own portfolio. Therefore, they are looking for a high-class partner that delivers sustainably the quality that their customers are expecting.

Njaal Kind, CFO, Gentian Diagnostics: Thank you. I think that’s what we had on the Q&A list from the audience today. I think if there is nothing coming in there last second, we will wrap up.

Matti Heinonen, CEO, Gentian Diagnostics: Thank you for joining. Thank you, Njaal and Markus and the team, for again preparing the update. We look forward to closing the year strongly, planning already, of course, for next year and then reporting the full-year results early next year. Thank you so much and have a good day.

Njaal Kind, CFO, Gentian Diagnostics: Thank you.

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