Gentian Diagnostics ASA (GENT) Earnings Call Transcript & Summary

Okay. Very good morning, everybody. It's May 7 and time to report Gentian Diagnostics Quarter 1 Report or Results. My name is Matti Heinonen, and I'm the CEO of Gentian. So let's kick off. Here's the important notice. And before we go to Q1 results, let's have a quick recap of Gentian, starting with our mission statement visible here on the screen. So Gentian at a glance, as you know, we are a medtech company, targeting a $1.8 billion serviceable diagnostic market, which is predicted to grow 5% to 10% per year. We operate with a very focused strategy. We have a lean business model and appealing value proposition for our customers. We have in-house industry-leading capabilities. We holistically produce and market our products, and we have extremely strong focus on R&D and operations. As you can see from the left-hand side, and again, here more today details, we are a company at commercial phase and making profit quarterly. Obviously, in this industry and to keep and gain the trust, it is very important to follow and be certified with very high-quality standards as we are. And as a Nordic company, we have extremely also strong focus on ESG. In short, what do we do at Gentian? Still nowadays, many clinically relevant diagnostic biomarkers are available only on either manual or not very highly automated systems and platforms. Our expertise is that, by leveraging existing open channel instrumentation, so we don't own or produce these instruments, but they are typically big central laboratory clinical chemistry instruments, and they operate also with so-called open channels where other companies like Gentian's assays can be utilized. And what we do is that, we select these not so automated biomarkers and convert them to be used on these high-throughput analyzers. And by doing this, what our customers and their customers gain is, first of all, faster results, which leads potentially to better treatment decisions. And also equally importantly nowadays still is the efficiency and cost saving benefits that can be gained. And when we talk about lean business model, it means that we use 3 channels to commercialize our products. The key path and way to market is actually partnerships with global IVD companies. So we OEM our products to them, and they secure the rollout and acceptance of the product on selected markets or globally. In some markets, we use distributors. And in other select markets, especially in the U.S., we also have direct sales to end users or 1 or another combination of these models. And as a consequence, we can commercialize our products with quite lean resources. How we are planning to grow? It relies on, of course, first, growing the established 5 products. We have an ambitious growth target of roughly 20% annually. Then we want to, of course, launch and grow the new products, especially the serum and plasma calprotectin GCAL. It is on market development phase, and you will hear again a little bit more today about it. And then our late-stage pipeline product, the heart failure marker NT-proBNP is making good progress, and we will again tell you some news today about it. But then we don't stop there. We have a healthy pipeline of new products, and we are about to make the decision about the next target in soon this year. And this can be done either in isolation with our own product ideas or in collaboration with one of the key players. And we want to do all this growth at the same time being profitable. And hence, we have ambitious profit targets, as you can see on the bottom of the slide. With this one, let's go to the Q1 highlights before I hand over to my colleagues. So Q1 and this year started really well for Gentian. We booked record sales and also had excellent profitability. Our sales were NOK 44.5 million, which represents -- sorry, 16% growth over last year. Our EBITDA grew to NOK 14 million from roughly NOK 5 million level 1 year ago. The gross margin went up to 64% and also our sales to Asia grew 30% compared to last year. And why that matters is, as you remember, second half of last year, we had some softness in our China sales and especially due to the value-based pricing tendering system being implemented. And we are happy to inform that our business is actually recovering well in Q1, and that seems to be also the trend at Q2, looking at the order book. Our key product, Cystatin C had a very good quarter, actually highest sales ever and with 18% growth to quarter 1 last year. And what was also good that this was driven by all regions and especially China and U.S. grew really well. From the other product category, the key 3 products, fPELA, cCRP and GCAL all experienced very high double-digit growth. We go back to the gross margin later. And -- but then -- and also, we actually do go back more to the NT-proBNP. But as a highlight, I want to mention that we are making still as planned, good progress with this late-stage development. And an important decision has been recently made, which is the calibration strategy for the product. And we have decided to continue developing an assay that is detecting total NT-proBNP, which is not affected by the glycosylation of the target molecule. And this comes with potential clinical differentiation to existing products. But again, a little bit later, you will hear more about that. So with this opening, I want to hand over to our CFO, Njaal Kind, and he deep dives a bit more to the financial numbers. Over to you.

Thank you, Matti. Good morning, everyone. I'm going to give a rundown of the numbers. So today, we announced record revenues of NOK 44.5 million, which is an increase of 16% compared to first quarter last year. Organic growth is 13%. We have growth from all products and all geographic markets, meaning that the growth is quite broad. What stands out is both the U.S. and Asia, especially Asia, which is an important market for us, saw growth of 30% compared to last quarter. As Matti mentioned, we see that some of the disturbance that we had in the supply chain last year due to what is known as value-based pricing seems to have passed and the supply chain is normalizing as we see it again. In the U.S., we have our own direct sales force, adding customers a bit by bit. Markus will speak about that a little bit later in the presentation. And the best product this quarter has obviously been Cystatin C, but we have grown on all products. Some of the smaller products like fPELA, cCRP and GCAL has also shown quite good growth this quarter. I'm also happy to announce regarding cost that not a lot is happening on the cost side. On the fixed cost, it's quite stable, has been stable for more than a year, meaning that we get more out of the resources that we have here. Going forward, we do see an increase. I would say, over the next 12 months, we would see an increase of maybe 5% to 10%, and this comes from the fact that a lot of our cost base is related to salaries and wage growth is still quite high. The gross margin for the first time, we are crossing the 60% threshold for the gross margin. And the main reason behind this is that, we are still harvesting from some cost improvement initiatives. And during the first quarter, we have had very strong operational performance, resulting in very good product yields. We also see more and more effects of scale advantage in the gross margin. Again, we are not adding as much cost as we are adding revenue also in the operations and production side. So with both the operational cost and the fixed cost being quite stable, we see that a lot of the increased revenue trickles down to the EBITDA. So our EBITDA margin increases from 19% to 31%. So that is a big increase on a quarterly basis. Going forward, we anticipate that the gross margin will stabilize around the 60% level. It will fluctuate mostly due to changes in mix, but also whether the quarter is on the strong side or the soft side regarding the sales. EBITDA, we tripled the EBITDA compared to quarter 1 last year and reported an EBITDA of NOK 14 million. That's a strong improvement. And we are already halfway to the full year EBITDA of last year. So, obviously, we are happy with that. Looking at the balance sheet, we have a cash position of NOK 88.7 million. That's a NOK 4 million increase in cash from the beginning of the year. No interest-bearing debt and our working capital is around 30% of the revenue. So a very solid balance sheet. That's it for me for the moment. I'll be back with the Q&A. Please use the questions opportunities if you have any and post them, and we will try to answer them out in the Q&A session. I will now leave the stage to Markus Jaquemar that will give a rundown of the product with more details. Markus?

Thank you so much, Njaal. Good morning to you as well from my side. Markus Jaquemar, Chief Growth Officer, Gentian. I'm obviously very pleased to report good numbers with more detail on the products themselves. And I would like to start with our flagship product, which is Cystatin C, our first product Gentian introduced. And as it was mentioned before, record quarter with NOK 17.7 million, adding more than NOK 1 million to the second largest quarter, which we had 2 years ago. And obviously, very, very positive that we have seen rebounding the business in China and strong sales in the U.S., as Njaal already mentioned. And so, we actually do see positive momentum in China with a good outlook for the second quarter because we have already an order book for that quarter. But we obviously stay cautious in seeing if there's any further impact from the changes that are happening in China. But so far, very good momentum in China for Cystatin C also because of strong performance of our partner, Beckman Coulter, who's performing the commercial efforts in China. We also received the largest Cystatin C order ever from our partner, Hanmi in South Korea, which is also notable in this instance. The U.S. were mentioned and just to add a little bit more detail here, we already added 19 new customers in the U.S. for Cystatin C, and that's really the result of our direct sales efforts together with a strong collaboration with our commercial partners in the U.S. And overall, this is driven by continued adoption of the guidelines that were implemented over a year ago. And therefore, we actually continue to see very, very good momentum. And as you may remember, Cystatin C is a kidney marker, which aids in the diagnosis of CKD, which is chronic kidney disease, impairing significantly kidney function. So this is an important element, and we contribute to actually addressing those issues around kidney disease. So very positive for Cystatin C. If we continue with our second flagship product, which is fCAL turbo. And please remember fCAL turbo is a product which is commercialized by our exclusive partner, BUHLMANN, in Switzerland. And in the last quarter, we have posted record sales already with NOK 18 million. This quarter, we have seen growth versus the same quarter last year, not quite as high as last quarter. But overall, the trend is clear. Fecal calprotectin aids in the diagnosis of inflammatory bowel disease, monitoring and diagnosis actually. And with the format that has been developed with fCAL turbo, adoption of this testing in the central lab is increasing and is accelerating, and we are definitely benefiting from that trend, which also means we're converting still older formats like ELISA formats to a fully routine automated assay in the central laboratory. Overall, positive outlook for 2025 for fCAL turbo and the collaboration with our partner, BUHLMANN. Very positive also is the other product category, and they start to add meaningful revenues to our sales overall. And as mentioned before, the 3 main products, fPELA also commercialized via BUHLMANN, by the way, canine CRP, which is a product for inflammation measurement in the veterinary business and GCAL, our calprotectin serum plasma calprotectin experienced strong double-digit growth in the first quarter, which is very positive, adding NOK 6.9 million in the first quarter to our sales overall. Specifically for GCAL, we would like to mention that we have kind of fine-tuned our strategy. We've been working with the product historically more on severe infections and prevention of sepsis areas. We have now focused a bit more on IRDs or inflammatory rheumatic disease areas, and that shows some positive results at this point. One additional point to mention is, we have obtained a second global partner distributing our GCAL product with Beckman Coulter in the first quarter, and that will also drive additional momentum for this product. And that is on top of our agreement that we have with Siemens Healthineers already since quite some time. So overall, very nice addition and contribution from our third-party products. Sorry, moving to third-party products. Third-party products are the products that our Gentian AB subsidiary in Sweden distributes in the Nordic countries, mainly BUHLMANN products from our partner. Also here, we see a very, very strong quarter. And if you start back to the second quarter in 2023, which seems to be the largest quarter, that included some hardware cash. So in fact, this quarter was the highest quarter with recurring reagent sales and a very strong performance here, growing 9% versus last quarter last year. Activities within the Nordics, including increasing our presence in Finland and Denmark with adding also a resource in that area. And one of the drivers of our growth is that, traditionally home brew type assays are being converted to IVDR/regulated products, which adds more quality and diagnosis quality for patient treatment. Finally, we also have a new agreement with Thermo Fisher to distribute our canine CRP wet product in Sweden, which also will add additional revenues. And summing up, if you look at the growth over the last quarters from a regional perspective, it was mentioned we grew 10% in Europe, which obviously on a larger base, 10% is also a significant growth as such in this quarter, but very positive growth in Asia with 30%, driven both by China and South Korea, as mentioned before, with a continued positive outlook in those areas, and our investment in the U.S. paying off with really second quarter of strong growth with our direct sales and partner efforts, mainly for Cystatin C and canine CRP sales. So overall, very positive results, and thank you for your attention. I'll turn it over to Aleksandra, please.

Thank you, Markus, and good morning, everyone. My name is Aleksandra Havelka. I'm CSO in the company, and I have a pleasure to inform you about progress made in the development of NT-proBNP assay. NT-proBNP, as you know, is a biomarker used as an aid in diagnosis of heart failure, a disease with increasing prevalence. Gentian assay will be unique in 2 ways. It is the only and first assay, which is not dependent on glycosylation of NT-proBNP in contrary to other commercially available assays on the market. And in addition to that, this is the first assay, which will be available on high throughput clinical chemistry instruments, providing cost-efficient solution for the laboratories and increasing productivity in the daily work. So we have during the -- actually during the whole assay development, but especially during the last months, we have reached out to experts within cardiology, laboratory medicine, potential customers and partners to decide unmet needs in the diagnostic of heart failure, but also use and added value of our unique assay. The assay, which is not impacted by glycosylation of the molecule. We have been strongly encouraged to continue with the development of this assay and launch an assay which will report unique total NT-proBNP values and rely on the new clinical cutoff. Glycosylation of NT-proBNP is unpredictable. It varies between individuals, but also within the same individual, it varies over time. And it is also affected by other diseases and comorbidities like obesity or reduced kidney function. All these factors provide a potential clinical differentiation by use of our assay, which will not underestimate the value of NT-proBNP in patients in general, but also in specific subgroups. So we are currently investigating the scope of extensive clinical evaluation and generation of evidence for use of this unique assay. We have also made significant progress in the technical development of the assay. We are getting closer to the next phase in the assay development and closer to the launch of research use-only version of the assay, which is planned for the second half of this year. And as we have previously communicated, full commercial launch is planned for 2026 and will depend on the time required for regulatory approval and registration. Our patent application has been accepted in Japan, which gives intellectual property protection in the third largest IBD market in the world. So that was all for me for now, and I'm happy to answer your question in the Q&A session. Thank you.

So thank you, Njaal, Markus and Aleksandra. Those were the key points and highlights from Gentian and Q1. Great news, good progress, as you heard. So let's go now to questions, and Njaal can moderate.

Just turn the screen a bit here so that we can see the questions better. You have the same picture. Everything is good. Good. All right. Let's start with some of those questions that we -- that relate to the quarterly report. First of all, maybe, Markus, you want to come and answer some of these questions. First of all, for tariffs, do you see any impact from the U.S. tariffs?

Obviously, when the topic of tariffs came up, we started immediately to get in touch with our partners in the U.S. and also contact our main customers. And the general practice is that, the impact of those tariffs can be and will be a further charge to our end user customers and our partners. And this is a normal process in our business. So we don't see any immediate negative impact from the tariff situation in the U.S.

Okay. We can add to that, that we don't expect to see a big impact either on -- at least on the current tariffs. Looking towards China and the business environment, the general business environment, I mean, the effect of the value-based pricing seems to have stabilized, but how is the general business environment in China?

So overall, any -- and let's be specific for the diagnostic business now in this case. Many of the IVD companies have reported impact of the situation in China. And the feedback is pretty similar. That means, in general, the amount of testing has been retained and maintained at a similar level compared to before the value-based pricing tenders. There has been a pricing impact as such/the same amount of tests but at lower prices. But in our case, we are not responsible for end user pricing. Our partner has made the correct efforts to retain the business in China. And so far, last couple of 3, 4 months, we have seen a very constant order level, which we also predict for the second quarter with, as you mentioned before, the order book is already in-house for the second quarter. We stay cautious to look at the effect for the ongoing quarters in the second half of this year. But the signals in general for our kind of a business are carefully optimistic.

Yes, because that's also a question is sort of what expectations do we have in China for the second quarter and for 2025 as a whole. And for Q2, it's looking okay. But for Q3, Q4, we don't have sufficient visibility at this point in time. Staying with the sales in the U.S., yes, you added -- you said you added 19 customers in the U.S. in Q1. Do you see this type of customer acquisition rate as normal going forward? Or are we on the high side, low side?

We really expect to be at that level going forward as well as the continued adoption in the laboratories is really very positive, and we see no signs of slowing down.

Okay. Great. That's good news. And staying in the U.S. Could you try to maybe throw a little bit flavor on how much time it takes from the time we acquire a customer until that customer is fully up and running with our product?

Very good question, actually. So the sales cycle for this kind of product from early contact to really routine implementation, I think it's about 3 to 6 months, right? And the process typically is, okay, you generate interest, the customer typically evaluates the assay, then you install the assay with our application support at the customer site. They acquire patient samples at that stage. And for full routine implementation, 3 to 6 months is the typical cycle.

Yes, I think that's all the questions relating to sales. So thank you, Markus. And Aleksandra and Matti, you might want to answer the next question we have here and that's related to the pipeline. And yes, and what considerations do we make when selecting pipeline products or products that we put into development? And can the risk of long development times like we have seen for NT-proBNP, can they be reduced? That's the question there.

If I take the first part of the question. So we are actually not only reviewing the pipeline. We have been revisiting our process to make the decision of next products. We are probably adding a little bit more robustness and analysis to make a holistic analysis of the product. We have learned more about the markets, but also the regulatory part and risk or likelihood is a key player in decision-making, and we are following a matrix that takes into account all these factors. In addition, we should, of course, also look at our current products, either commercialized or about to be commercialized and the pipeline what we have. As you have heard and can see from the report, we have already the next product in development. That is still an undisclosed product with undisclosed partner, but it is one of the key global players, as we have told. And that represents maybe the other extreme, but a little bit different kind of product development compared to NT-proBNP because it is a product with a known partner and existing market. And that is faster, of course, if successful. And we know that there's a commercial partner there. But then typically, low risk doesn't come with high yield. So -- but it's about going forward, we want to balance the pipeline. So we are about to discuss and create maybe some rule of thumb what should be the ratio of higher risk longer-term product development projects versus other type of projects. And then we make the decision each time based on that current situation. So this was a bit long answer, but it's a very important question. Of course, something we can never fully predict is the biology. And does it work as we want it to. And that can always, of course, give some roadblocks or slow down the process. But anything for the NT-proBNP learnings?

Yes. I mean, as you said, Matti, our pipeline portfolio is a mix of different products, and we need to balance between technical challenges and commercial challenges and also trying to be unique and not to me, too, product in the company. So it's a very good question, and we do our best to balance and mitigate the risks. And, of course, ideas from potential partners about products with higher commercial potential are prioritized. And yes, we are trying not to get into very technically challenging product development.

And maybe last thing to add, those collaborations Aleksandra mentioned, that is one part of our customer relationship building. So we want to move and we are moving further and deeper already with certain customers, a couple of them to be more -- even more a strategic partner for them and really a go-to partner when they cannot or don't have resources, for example, to develop a certain product. So that's a position where we would like to be even more in the future that Gentian is always on top of the mind when such a product idea comes to their mind.

Okay. One additional question here regarding product development and NT-proBNP. And as we explained earlier this morning, our calibration strategy has been set so that we will, in fact, now make the remaining development on a differentiated product. So it will not be completely, let's say, similar product to what is in the market today. And the question goes towards the commercial side of it. Do we anticipate a slower or a faster ramp-up when we have a differentiated NT-proBNP product in the market?

Short answer is yes. It will be a bit slower. So it is important to manage the expectations. First of all, we need to define and create that clinical proof package in addition to the regulatory requirements for the product. And this will happen probably in 2 phases. So we aim for the IVDR approval CE registration as communicated during next year. And in parallel, we will also generate this clinical proof package for the added clinical benefit. That may be required for the full -- exploiting and capitalizing the full commercial potential of the product. So yes, it will not be like walking directly to the market. But at the same time, with this kind of differentiation, and this was a strong advice from every potential partner we have discussed with, they were all 100% behind choosing this path. And then, of course, important to note is that, like with every development, nothing is 100% sure before it's proven. So there's a very strong hypothesis and perception that this glycosylation impacts the results. But then in the end of the day, we or together with a partner, we need to be able to prove that in clinical trials as well.

All right. I think that was the end of the questions list for today. Just as an FYI, we will be back with our second quarter earnings release and presentation on July the 10. In the meantime, if you have any questions, please do not hesitate to contact me directly. Yes. So that's it for me. Any closing words from Matti, Aleksandra?

It's always a good opportunity to thank the whole Gentian team. R&D operations doing excellent job progressing our products, running our operations smoothly and without any hiccups, delivering excellent results and the sales commercial team all around the world, delivering these great results. So thank you, everybody, in-house. And also thank you to all our investors and Gentian friends out there for following and trusting in us. See you in July, latest.