Happy July, and congratulations for your football success so far in the World Championship. My name is Matti Heinonen, I'm the CEO of Gentian, and I'm here with our CFO, Njaal Kind, to present our Q2 and first half of 2026 results.

Here are the needed disclaimers. Before I give a short update and presentation of Gentian, and before we deep dive into the results, let's go directly to the highlights of the second quarter and first half of the year.

We had the record high Q2. We had really nice sales of almost 50 million NOK, which is plus 14% compared to Q2 last year, or 20% organic growth.

With that we mean currency fluctuation corrected growth, which is more the underlying volume growth. We had sales to the US, 10.4 million NOK compared to 7.2 million a year ago, EBITDA at 8.1% compared to 1.7% last year Q2, and gross margin returned to our desired level at 55% compared to 44% Q2 last year.

Some additional highlights of the quarter, we are really happy to see that the two major and key markets, Europe and US, are growing really well. Europe grew by 21%, and US again closer to 50% quarter over quarter last year.

These two regions luckily more than compensated the softness we see in China, and we will come back all these numbers and reasons later. We are really pleased also to see the fCAL turbo and the whole BÜHLMANN franchise delivering nicely.

fCAL turbo increased by 35% in Q2, and also together with fPELA, they are contributing, and we expect them to contribute nice growth this year and going forward. Importantly, we implemented a new R&D strategy in Q2, and that is to support a more disciplined prioritization of R&D resources and capital allocation.

We will maintain the current R&D spending, because, as you will see later, we have a lot going on at Gentian, but we are really targeting a return on capital employed of more than 20% on new projects. Then we were really happy already in June to announce the first of hopefully many new partnerships with the Dutch company, Sansure Reagents, where we are exploring several assay development collaborations with them.

Again, I'll come back to that later. That was the quarter two, really good performance, and we're really pleased to see what's going on commercially.

When we look the first two quarters together, we again recorded double-digit organic growth, sales almost 94 million NOK, which was plus 6% or plus 12% organic growth. Sales to US again significant growth to 19.1 million from 10.9 million a year ago, EBITDA at 13.1% compared to 15.7%, and gross margin stable at 54%.

Njaal will come back to these numbers soon. Again, some additional first half of the year highlights, we had very very good performance of cystatin C, like said, especially in the US, but despite that, we decreased by 9.7% compared to first half of last year.

That is mainly due to softness in China, like said, and as that has been going on already for quite some time, but we haven't had a major impact luckily from there. Also order facing to our South Korean partner, who are actually increasing their sales and forecast, and because of that, they split their traditional two orders per year to three, and we got one order from them during the second half, and we are expecting or getting two orders on the second half of the year.

The sales for them, which impact both GCAL and cystatin C, are more on the second half of the year. Again, US, the first half of the year growth plus 33%.

Still we say here adjusted, that is the warehouse shift that happened last year April. Q1 was still impacted, European and US sales split by this shift, but Q2 and going forward will be apples to apples, which will be easier for us and for you to understand the numbers.

That is really building on the great momentum of cystatin C, but also our and our partners' increased investment. Again, fCAL turbo and fPELA turbo, very good performance from our partner, BÜHLMANN, and we expect them to deliver a solid growth, to say the least, for the full year, and hopefully also going forward.

Then for the second time ever, we paid dividends as a company in May, 0.6 NOK per share, and that was based on the solid cash position we have, sound underlying earnings, and we have all our growth opportunities fully financed. These were the quarter two and first half of the year highlights.

Now I go quickly to talk about Gentian, and before I hand over to Njaal, and then I come back for the product and R&D updates. We have renewed our mission, here you see our new mission that we work for everyday here at Gentian.

We are here to improve patient outcomes with world-class diagnostics. We also stated the company vision, what we want to be longer-term, and we want to be and will be the innovation partner for global IVD companies, in short.

This is us in a nutshell. As most of we are a MedTech company serving a diagnostic segment worth $1.9 billion, which typically we choose areas that are growing above the market average.

We work with appealing value proposition, we can operate through a lean business model, and we have a focused growth strategy. We have industry-leading capabilities in-house, and especially strong focus on R&D and operations.

As you can see on the right and left-hand side, we are a commercial phase company making profit. Again, equally important as always, high quality is key for our success and for our customers, and focus on ESG.

Here you see the key products we have. We have five established products, one in market development, and now one new project stated here in moving to the late stages of product development.

The key disease areas where we at the moment operate are inflammation, infection, and kidney disease. As cystatin C, our first product launched already in 2006, is the biggest product of ours at the moment, and that is exactly used for the diagnosis of chronic kidney disease.

The next two, fCAL and fPELA turbo, are commercialized exclusively by our Swiss partner, BÜHLMANN Laboratories, and they are focused and specialized on the fecal testing among couple of other areas. This has been and continues to be a really good and fruitful collaboration between the two companies.

We have one product for the vet market, CRP for dogs. Then we have an insourced product from some years ago, retinol-binding protein, which is still finding its way.

Then we have our own calprotectin for serum and plasma, which is in market development, and especially in the report we give updates about the data generation we have achieved and are doing for that product. Then we have this one still undisclosed assay for undisclosed partner, which is one of the top five companies.

It is progressing well. I will give a short update about that later, and we are still aiming and on track to launch that product together in 2027.

Here are the key drivers for our long-term growth, and then some key financial KPIs for that time. With this one, I conclude the opening, the highlights, and then I hand over to Njaal, who will go through the financials, and then I come back for the product update.

Over to you, Njaal.

All right. Thank you, Matti.

Good morning. I will make a rundown of the financials.

My name is Njaal Kind, CFO of Gentian Diagnostics. Starting off with both geographic and product split, this morning we announce revenues of 49.8 million for the quarter and 93.7 million NOK for the first half of 2026.

Growth compared to the same quarter last year was 14%, adjusted for currencies or currency neutral organic growth, the growth came in at 20%. For the first half, the growth is 6%, and then again, adjusted for currency movements, 12%.

As you can see, we have strong growth in the US, reporting 10.4 million, that is up from 7.2 million last year, and that is a 44% growth. For the first half, the growth is 73%, quite strong.

We see the opposite picture in Asia, where we in fact have a decline to 7.4 million NOK revenue in the second quarter from 9.8 million same period last year. That is due to let's say a soft development in China.

Historically, we have seen sales being quite choppy to China. Last year was quite good, year before that was quite weak.

Now we are seeing some weakness again. Difficult to really predict which way this will go, also on a quarterly basis.

Other markets in Asia has proven quite good, and we expect also those markets or countries to do well in the second half. In Europe, growth is good, 21% on the quarter, and here it's fCAL, fPELA, the BÜHLMANN franchise, which is performing positively in the quarter.

As you can see, fCAL turbo, if we go to the product split, we see that fCAL turbo has 17.3 million of sales in the second quarter, and compared to 12.8 million in the same quarter last year. Cystatin C overall is very good, 18.3 million for the quarter and 31.7 million for the first half.

Overall revenues at a record level, as you can see. Jumping to the fixed cost level, not a lot to say there because it's very stable.

As you can see, we have not capitalized any development expenses in the first half, but comparing then back, we can see that the overall expenses are quite stable. R&D expenses looks to be increasing significantly, 9 million compared to 6.7 million in the second quarter of '25.

This is due to the fact that we have stopped capitalization and we are now booking all R&D expenses over the P&L. If we adjust for that, on the total OPEX, we see it in fact down with 3% when we compare to the second quarter of '25.

The capitalization effect in the first half is in fact 4.2 million that let's say has not been put in the balance sheet, but has been expensed over the P&L, and that was not the case last year. Looking at the gross margin, as we have said, we should be in the 55% to 60% range when it comes to gross margin.

This quarter we report 55%, this has to do with the relatively high revenue level and decent, smooth operations in Q2. It's becoming more challenging to keep this gross margin level with the currency or the foreign exchange levels that we have seen during at least the quarter two.

Again, quite volatile currency environment these days, but of course we are exposed to a strengthen NOK. EBITDA, we report an EBITDA of 8.1 million for the quarter, and that is an EBITDA margin of 16.3%.

Now again, in order to make this comparable to the historic levels you see, the capitalization effect here is 2.2 million. If we had capitalized 2.2 million during the quarter, in fact the EBITDA would have been slightly above 10 million, which is a satisfactory level at this revenue level.

Looking at the balance sheet, we are reporting a cash position of 79.3 million, that is very close to where it was the same period last year. Bear in mind that we have recently paid a dividend of 9.3 million, and that's an increase of 50% from what we paid last year.

We have an increase in the working capital in the second quarter. There are some large accounts that is driving that increase, and that is normal variation, and we expect many of those accounts to be settled during July and August, and that the working capital in fact will calm down during the third and the fourth quarters.

On the CAPEX side, you see that we have a very low CAPEX, and that is due to the fact that we are not capitalizing on the R&D projects. Free cash flow minus 3.3 million, and as I said, that is due to working capital movements.

I guess that was all from me in this section. Please use the questions box on your screen if you have questions, and I'll be back to moderate the Q&A session when we get there.

I hand over to Matti again for the product update. Thank you.

Thank you, Njaal. Let's go a little bit deeper into the the key products and and their performance.

Cystatin C, like said, all-time high quarter, driven by growth in the US and and in Korea. So 18.3 million in in second quarter and growing 5%.

The year-over-year increase is really mainly driven by the US and and coming from our partners. Like said, we are investing more in that market, we just added one more head count in May, but also we see and work for improved and more closer collaboration with the partners in the US.

That ordering pattern I I already explained, instead of half of the sales in in first half, we got 1/3, and we are expecting 2/3 of the sales for cystatin C coming on the second half of the year. Really the underlying demand for cystatin C is driven by the updated guidelines and and the investment levels, and it happens across the markets.

We do expect cystatin C to be a a key product for Gentian also going forward, and and we are working hard to be recognized as the cystatin C company in the world. fCAL turbo again, like said, excellent second-quarter performance with expected high teens growth for the full year.

Last year, as you see, the the Q2 was the lower one, so that's why the 35% growth, but still we do expect very good growth for the full 2026 compared to last year. Then this is driven by BÜHLMANN adding several new customers, accounts both in Europe and in the US, and they have a couple of really good and important negotiations going on.

In addition, their old and newer partners are also starting to deliver, and and that contributes to the sales. We can say and be pretty confident that the BÜHLMANN franchise will be a key growth driver for this year and and going forward, and the collaboration between the two companies is really good.

The other products category, which consists of cCRP, fPELA, GCAL, and RBP, delivered 16% growth, again really good performance, and and 8.2 million compared to 7.1 million last year same period. The forecasts from our partners for the key products are good, and they remain on the communicated targets, so we can have good confidence there.

I want to especially mention fPELA performance. As we don't at the moment yet report separately these sales and growth, but fPELA delivered even higher, clearly higher growth than fCAL during the Q2 and and first half, and BÜHLMANN and we are expecting that to continue.

FPELA is really ramping up at the moment, and one reason is that because from the same collection tube they use, the customer can make both assessments, fCAL and fPELA, and this upselling of fPELA together with fCAL is really driving the sales nicely. Then when we look at our distribution business in Nordics, the third-party products, they had a good quarter, 6 million sales, among the the top highest ever, but still minus 6% because last year the Q2 was was really good, 6.4 million.

The the start of the year Q1 was a bit softer. We communicated then that that was due to delayed orders, and we did see a lot of orders coming in now in Q2, and the order book is and keeps building nicely.

The team is confident for the full year deliveries and results. The the organization continues to further find customers on the Nordic region, and also looking for additional products to their portfolio to have the growth in the future as well.

Again, we have had a couple of smaller, but also a a bigger win or able to secure a multi-year contract with a major partner recently. All in all, this third-party product sales and and the business looks looks good for us as well.

That was all about the sales and financials, and one of the the key updates of today is actually the R&D update and and summary, and I will now cover that one as well. I want to spend a little bit more time here.

After the NT-proBNP decision that we communicated in May, and of course getting ready for the situation if if that happens, we have been looking how to be more efficient at Gentian. We have built actually a new R&D strategy, and the the aim is to accelerate new product launches and manage also the risks of of these projects.

Going forward, our R&D strategy is built on three pillars. I go first through them a bit faster, and then I may take some points up also later.

We want to have more product launches, that is obvious. We haven't launched products in many years, and and that has to change.

We will have a much more dynamic pipeline management approach, which combined with more agile development processes, meaning faster development, will and should result in in more launches in recent or in coming years. Also we will more officially increase focus on the on the vet market, building on on the success of cCRP, and and we have great relationships with the key companies in that area, and and that is a very good starting point to either convert existing products from human to vet, which is easier and less regulated, but also to to develop new products per their needs.

Second point is expansion to point-of-care through partnerships. There is a turbidimetric point-of-care segment, which is attractive, adjacent opportunity that we haven't exploited in the past that much.

Actually in the vet area we have, but not in the human diagnostics. Our existing assay portfolio and our development capabilities are well-fitted and suited to be integrating integrated or to develop products to be integrated on partners' platforms.

Also then a bit longer-term and combining the point three, the emergence of the high-sensitivity technology, which will be especially suitable for the point-of-care platform, that will further expand partnership and assay development opportunities in this area. Third, last but not least, really we are now increasing and solidifying our focus and investments on the high-sensitivity technology.

The reason is that the key limitation of PETIA assays, the the traditional assays Gentian has been and will be producing, is sensitivity. That means that we don't have unlimited number of assays to be converted to turbidimetric assays.

With this high-sensitivity technology and and our data so far, that has demonstrated up to 100 times improvement in sensitivity, which, when we analyzed the assays and or biomarkers which exist, can lead up to roughly 100 additional biomarkers being within the reach for for this technology. One can understand that would have a really big impact and and really game-changer technology in in in this area.

That technology is, in theory, applicable both for point-of-care and core lab instruments, but like said, the the smaller point-of-care instruments are are the easier and first step for us and the partners forward. Then so this is these three areas.

With these, we are aiming to clearly accelerate the number of product launches, and also to manage the risks. What does that mean?

I can especially elaborate the dynamic pipeline management approach. The biggest change to the past is that we used to have one or two development projects that were decided and run then until the end.

Now what we will do is that we will have several projects running in parallel. We will do early exploratory work, we will generate early data to have good pitches, and then a very important decision go, no-go or go point will be commercial interest or some sort of partner commitment or interest for the project before we put the pedal down and and invest all the way.

In this way, we can explore much more assays or projects at at a time, and it will be a combination of our in-house, highly innovative projects combined with the business development driven, insourced, or collaborative projects. All that should also manage the risks of failure or increase the probability of success.

We are not only anymore talking. I We do understand and know that after the NT-proBNP decision, there were many questions, rightly so, that what's the future of Gentian and and what's there after that project?

We are happy to reveal now already quite many projects we are working on, but this is not actually even all. Before I go into them, a very important disclaimer for this slide and whatever we disclose going forward, and that is that we don't expect all of them to succeed.

When we work on several projects and we do the feasibility and exploratory work and we have the partner commitment as a key go, no-go decision, any of them can fail at some point. That is exactly the the way, innovate, fail fast, and then move on once you have a higher probability of success.

Do not expect or do not be surprised if going forward we need to inform you that one or couple of these will not move on. That is exactly the the the idea of the more dynamic, but broader pipeline management.

First, let's And yeah, again, I want to also reiterate something that we have had many questions, that is Gentian moving away from being an innovative company and and only becoming a service partner? That is not the case.

The focus remains in proprietary assay development, which will be then complemented by, for example, paid development partnerships and technology licensing and collaboration opportunities. It it will be a balance and mixture of of these kind of projects.

You have and we have here examples of of all of them. On the left-hand side, on the top, this is the the ongoing assay development that already made to the product slide as well for the key IVD partner.

The good news is that our team in in Gothenburg, the early research team, has concluded their job. We seem to have, as data shows now, a well-functioning assay in our hands, but of course further work is required, and and the development is now moving in July to Moss, where the final stages of the development are done.

Like said, the project remains on track for quarter quarter four, sorry, 2027 launch with the partner. Whenever we are able, we will obviously announce the the biomarker and the partner.

Then we have this recently announced partnership with the Dutch Assure Reagents. They are a a company with a strong portfolio and great assays, but not all of them or not on the clinical chemistry or PETIA platform, and that is where Gentian comes into the game.

We will and are exploring the collaboration to bring first already couple of assays to PETIA platform. We are already in the phase that our labs will start testing those assays now in July, August, and at the same time we are discussing discussing the the commercial terms of the future collaboration.

This could be, at the best, something like our collaboration with BÜHLMANN, for example, similar kind of strategy partnership. What is also important that these assays are for existing market, no market development as such needed from scratch, and there is interested partners or partner for the assays.

That those or this project, this partnership ticks many of the boxes that we require going forward. Then, in addition, we submitted in early June an offer to to do two paid development projects for a major vet IVD company, and that includes also option to act as a test manufacturer, and that will be typically be the case.

We may do sometimes just a paid development, but our business is in manufacturing the tests, and that that is our base case always. We are expecting decision in the near future, and and we'll give updates when we can.

This would be very important and and very quick step to that vet area that I mentioned in the previous slide. Then so far we have been discussing about the high-sensitivity technology more on on just our own exploratory work and and having high hopes, but we are also happy to say that much more concrete things have been going on and and are going on.

With the first partner, the co-development collaboration for the high-sensitivity point-of-care instrument has started, and and that company will start now building a prototype of their current instrument having the high-sensitivity technology inside. We have commercial terms again under negotiation, and further information will be provided when we are ready.

That is really really exciting opportunity, and and the partner is also excited about that. We are trying to expand these collaborations going further.

Then, in addition, in-house we have initiated three projects. One is a product improvement project for for our own product, existing one.

Then we have or we have actually initiated two early-stage exploratory projects for new PETIA assays. One is a biomarker for cardiovascular disease, which is not NT-proBNP, and the other one is for liver disease.

These are early, but but going in different phases, but they represent these in-house proprietary assay developments, when many others you see here are more the partnerships. This is exactly the balance of the pipeline again that we want to have going forward.

Like said, this is not even all, but these are the ones we can at the moment mention at this level. I know you are hungry always to to learn more, but but we have to respect our partners.

Sometimes there's more than two partners in the negotiations, and and we do always our best to inform you as soon as we can and are required to. Then last slide about R&D.

We want to again say that the R&D spending will remain, we will remain as an innovative company, but just looking to to be much more productive and have higher return on on capital employed on R&D. This is due that due to the fact that, as you saw, we have many many projects ongoing, and at the moment we can manage those with our existing resources, but obviously especially if they are paid developments, we don't have to take the the monetary risk of the development ourselves, that gives us an opportunity to to investigate even adding resources if needed and if several projects successfully move on.

Then also we want to just mention here that our VP of R&D resigned in June, and we are in or we have started the process to hire a new lead for our R&D, leading all this I have now talked about to you, and and taking our R&D capabilities and deliveries to the future. We hope that will always take some time, but hopefully by the end of the year we have there news or or somebody already in place.

On the right-hand side, you see already the traditional breakdown of the spend, because we book under R&D also the the technical and clinical support for existing assays, and the pipeline development is really the new assay development. Now, as you see, and Njal mentioned, that we didn't capitalize anything in Q2 due to the termination of the NT-proBNP project, and others not far enough yet to be capitalized.

With this one, we actually conclude the the quarter two and first half of the year presentation, and now it's time for Q&A.

All right.

Can modify.

Thank you. There's been a good number of questions coming in during the presentation here, Matti.

Let's start with more the operational questions first. Cystatin C, we have a few questions regarding that on let's say both geographically, but also new customers, existing customers, and are we able to separate fully new business and existing business?

The question is also, where are we winning new business?

Several questions. Geographically, US is leading, and typically both in diagnostics, in pharma, the uptake is faster due to their healthcare model, reimbursement model.

There we do see the fastest uptake of cystatin C. Just to remind, cystatin C is mainly used together with creatinine, which is something you may recognize that when you take your normal test panel, the creatinine clearance is something that is used to indicate how your kidneys function, but there are certain situations when creatinine is not enough or sufficient, and cystatin C adds value.

That guideline update that happened already more than a year ago, that has really really supported, but it always takes some years. Europe is coming.

It's not that it's only US growing, Europe is also coming up, and we do think that cystatin C will be a major product for us and major biomarker going forward. The opportunity there is that there's, as again in diagnostics we don't have as exact data of market shares or usage as again, for example, with the pharmaceutical drugs, but some data indicate that maybe maximum 10% percent of labs in the US that measure creatinine measure also cystatin C at the moment.

The other way around, 90% of the labs are still naive for cystatin C testing, and that is exactly the opportunity and those that our partners and ourselves, we're directly targeting. The fact that we have two partners in the US that both have actually quite nice market share of the total instrument base, so that gives us already existing opportunities there.

Then to the new sales, that is true, we didn't report now actually the separation of new sales. We did last year.

It was roughly 14%, 15% of sales coming from new accounts added. We have again also added new customers this year.

If I remember correctly, it's roughly 10 new accounts added and several that we are negotiating. That is exactly the future growth is that we add more labs using cystatin C, and we can have a separation between kind of the existing sales and what the new labs are delivering.

Yeah.

Just to add to that, that is the minimum what we can say about new business. When it comes to some of our partners, we do not have full transparency if their sales is on existing business or new business, but we see that they are growing, I think it's fair to assume that they are also adding new business to their accounts, which is then has as an effect on the demand for our part.

That was important, yes. That's why we can't all the time report like an apples to apples because we don't get the data.

Correct.

Fully.

Correct. Let's stick to cystatin C.

The question about these KDIGO guidelines, do we expect any further changes to the KDIGO guidelines that could impact the adoption of cystatin C?

I haven't heard, and I'm not aware the guidelines per se being actually the limiting factor. What we do know that what could really open up and will open up this market is actually changes in reimbursement.

The current reimbursement in the US doesn't cover all the patients that are covered by the guidelines, and that is something that especially the partners, the key players who know the US market and have big departments working on the reimbursement changes are driving those. Once we and they can get broader reimbursement based on the guidelines, that will drive especially the future growth.

Thank you. Cystatin C in China, so as we spoke about, it's choppy.

Now we are seeing a decline, and yes, we have also previously spoken about that there are changes in the environment in China. The question is, is the revenue level we now see, is that sort of a new structural baseline?

Secondly, what do we assume for the future when it comes to sales to China?

For the latter one, I guess we and many other companies can say that we don't know fully. That market has and is changing rapidly, and the transparency is not always clear, and the competition is obviously massive.

It is split between the kind of the foreign company segment and then huge number of local competitors. I have to say, if you look at, for example, the key IVD companies and how they have in many quarters back reported their sales in China, we have seen tens of percentages decline in their sales, which keeps going, and I would say probably longer than expected.

Us not growing, but being able to roughly keep the sales level where we have been, I think so far has been a success. I would like to knock the wood if there were any here, but our approach to China at least is to keep close to our local partner, Beckman, which we do, get as much information as possible, support them to our best, and try to defend the market and the sales, and then when the situation stabilizes, then we can again look at maybe investing more or launching new products.

Looking at this historically, we have seen significant volatility in sales to China, and it's difficult for us to separate between what are let's say structural effects due to policy, changes in regulation, etc., and what are effects of let's say variations in the supply chain, because we have seen big variations in the supply chain previously as well. This time around, it's the same.

We have yet to find out what is the real cause of the decline in China.

That is true. There has been very soft months and quarters, and then suddenly they have been backed the stock, but we don't have full transparency, like Njal said.

Yes. Let's keep still on the operational side.

There's a question here, it's sort of a hybrid. The question is, we have cystatin C and fCAL turbo is about 70% of our revenue, and the question is, when do we expect sort of another biomarker, either one of those we already have or one of the new biomarkers that we are investigating, to come in and contribute with meaningful revenue, is the question here?

That question obviously addresses a key risk. Luckily, we're not one-product company, but we are very much dependent on these two products, which again are doing well and the outlook is good, but still that is a risk to manage.

GCAL has taken a long time, and as we have communicated, we pivoted our focus from the primary focus from infectious and sepsis to rheumatoid arthritis, which seems to be a better area, but still it is slow start there, but we have also allocated actually some our sales resources directly in Europe behind the product. It is really the key reason and a key expected outcome of the new business development and R&D-driven model is to get faster new products that can start contributing meaningfully.

We do have couple of those projects mentioned here or not mentioned that potentially could become equally big product longer term than cystatin C and fCAL. That is exactly one of the key reasons to, first of all, sustain the historical growth of the company.

We need more products to support that one, but also, like said, to de-risk being dependent on these two products too much. How long, and that's also the kind of a potentially benefit and beauty of the more business development driven opportunities that for some of them, the expected development time can be much shorter than for a project we start from scratch in-house.

Hopefully in coming years, we can't yet say exactly when, but the CH50 is of course coming, but it's not going to be maybe the key product, but a mid-sized product, but hopefully in couple of years we can launch and already commercialize some new products if everything goes well.

All right. Thank you.

Back to cystatin C in the US, can we say anything about the long-term potential for the product, and could we also say something about the competitive environment for cystatin C?

Last year at the ADLM Congress, which is now again in couple of weeks, there was a session focusing on cystatin C, and they showed a number of, in 5 to 10 years, that market could be in the US only $450 million. That is one number, but it still tells that it can be a significant market opportunity.

fCAL, for example, I guess is the numbers we hear and talk are $150 to $200 million market, it could be more than double-sized market, for example, compared to fCAL. Competition is there obviously, and it's getting harder obviously when the guidelines change and the sales start to pick up, more companies come in, and luckily the price is still, in good and bad, perceived high, and it's quite okay.

We haven't seen massive price competition, but we have to of course stay vigilant, and we have to keep improving our own product also all the time to keep it competitive going forward.

Okay. Thank you.

fCAL, the same question almost, if we can comment on the competitive environment for fCAL. It's a competitive market.

Maybe you can say something about let's say the advantages of fCAL turbo, which are the main selling points for that test, which makes it quite competitive in the market?

I talk all the time, you can take that equally well, but I can start. That market, BÜHLMANN is well-positioned, and they are really well known for that one, and the key advantage of BÜHLMANN is their collection device or tube, and it can be used for, like said, both for fCAL and fPELA.

They are even planning to add maybe new products on the same, or separately, we'll see. What is important is that fecal sampling is becoming more and more home-based.

Patient take the sample at home and they ship it by mail, and that collection tube device is really well suited for that, better than many others. Secondly, that is actually one of the most or best automated collection tube, and so that also splits the market.

Some of the key competitors, like DiaSorin there, their tube is not able to be automated in the same way, they compete a little bit on the different volume segments. The competition again, there's some companies probably propping out and others getting stronger, but BÜHLMANN is one of the leading companies, and with their new owners and new CEO and new team, their targets and what they seem to deliver already is to solidify their leading position in the future.

I am actually confident with BÜHLMANN that they can deliver also going forward really well.

Thank you. Let's move a little bit.

There are a few questions regarding the let's say revised or new R&D approach and strategy. I think first of all, and maybe to clarify that, what are we thinking about the positioning of Gentian from here it says OEM partner, I read that as a contract manufacturer, classic contract manufacturer versus a deeper partnership model?

Of course terms and how they're understood are different, but basically we are OEM partner per se. We do tests for the key companies.

As we don't have our own instrumentation. We rely on the open channels of this core lab instruments and so on.

Still really what we want to be and seems to be also the need for key partners is stronger strategy partnerships. They are consolidating, the key players, our customers, they are consolidating their third-party supplier base.

The reliability, the trust, the history of delivering without issues, all that is becoming even more important, and Gentian is actually well positioned. We are getting more and more discussions and calls saying that they want to collaborate especially and exactly with us, and so that is where we want to be.

We want to be that strategic partner who can do both development, but be the manufacturer under Gentian brand or their own brand going forward. That is not really changing, although the source of the new projects and products become more diversified.

I think it's also important to add here that we also seek a deeper relationship on let's say where we can add clinical support, we can add regulatory support. We are not just let's say producing and shipping it onwards.

We have capabilities in the background, which is very important for many of these partners.

Very important. That is highly valued.

We run through the questions here. I see that we are 2 minutes to 10:00, but I think we can go a few minutes over if there are still interest in listening to us.

Let's say, what is the current level of R&D spending? This one we can answer quite quickly.

For pipeline development, it's 6.6 million, and then we have 2.4 million, which is this technical and clinical support that is related to existing product. If we say what are our investment component in new products, that is the 6.6 million.

The question is...

Per quarter.

Per quarter, yeah. The question is, will that continue?

I think as you can see, we are at about 6 million per quarter, I would say between 5 and 7 million. It will fluctuate a bit depending on, for instance, clinical studies or other external projects, but we are clear that we are aiming to maintain the R&D expense level going forward.

We are quite busy these days, but we are also well resourced to take care of many of those projects that are on the books right now.

Yeah. Yes,

I think we answered a few questions there. Let's go to the high-sensitivity initiative.

As a question here is also stating that this is a potentially let's say transformative project that could change Gentian a lot, but it could also change let's say the industry. The question is, where are we on the maturity curve of how developed is this project now, and when do we expect sort of either to see some revenue of some sort or that we enter into some cooperation with someone about this?

The business model there is that we can expect, and we do expect, two kind of revenue, main key sources. One is milestone or licensing fees, and second is then being the kit manufacturer for high-sensitivity kits.

That is very important. We are not developing that technology just to license the technology itself out.

We want to be, like with the current business, also the kit manufacturer and developer for the additional assays that can be brought. What is really important, I first of all start with intellectual property.

We have already filed patent or patents for high-sensitivity technology, and we are in-house developing a new, even improved rig to continue that work. Protecting our innovation here is key, and that's part of the development.

We have run several biomarkers on the first rig, and from where we have these data showing this impressive increase in sensitivity, and our team says that actually that even up to that 100-fold sensitivity gain has been achieved with very little optimized instrumentation. Once they keep working on the processes and the technology, we can even see better results there.

Now the next steps are really that we have a concrete partner, which hopefully we can announce at some point once we have agreed on the key terms. You can understand this is a long-term, high-investment project, especially from the partner's side, also the term sheet and contract is quite extensive.

Licensing fees, milestone payments hopefully quite soon if that moves on. Then what we have to keep in mind is that before we can develop or register a kit for high-sensitivity technology, the instrument has to be there and registered, and that takes time.

I can't yet, because that company is now really starting to sketch and work on the prototype, I hope we will get some timelines from them later. They are super excited about that one, because similar to us, the immunoturbidimetric point-of-care companies are also very hungry for new assays, and with this increased sensitivity they might be able to build panels to customers that are not reachable or feasible at the moment.

Thank you. One last question, an easy one, let's say, regarding our expansion to the veterinary market, are we also planning to have instruments going forward?

No. Both for high-sensitivity technology and vet business, still we stay where we are strong, which is the kit development and manufacturing, and we will partner and collaborate with companies who have their own instrument platforms that we then become experts, as we are now, and can do the validation of the assays and help them there.

We are not planning to develop or OEM any Gentian assay platforms.

All right. Thank you.

We will wrap up here. There are a few unanswered questions I can see here on the list.

Please reach out to us if you want them answered. We are happy to do that on a one-on-one or email basis.

That also goes for everybody else, if you want to get in touch with us, please just reach out, happy to take the discussion further.

Good. Thank you.

I guess I just conclude by saying that again thanking all Gentian staff for the great results and great focus, and putting really skin in the game both commercially and in R&D. We are happy to report a strong Q2, catching up the softer Q1.

We are confident for the full year, basically China business being the only clear known risk, but that has been actually accounted for, more or less. Then very importantly, this R&D focus and model, and of working change with already so many concrete examples that we will then tell you more, we promise, whenever we can.

We see and we are excited about that as a leadership team, as a company, and we believe that that can change the trajectory and history of launching many more products in coming years. With this one, stay tuned, have a nice summer, good luck against England, thumbs up for Norway, and see you then in October.

Thank you. Bye-bye.

Thank you.