Devyser Diagnostics AB (publ)

Good day and welcome to Divisor Q2 2025 earnings call. I'm Fredrik Dahl and the acting CEO of Divisor and would like to thank you everyone for joining our call today. On the call today we have, in addition to myself, also our CFO Sabina Berlin and our Chief Commercial Officer Thijs Kipling. I will start with a short summary of our quarterly results and then recap our recent activities that have resulted in an improved efficiency overall for the organization. I will then give an update on the recent product launches and present some additional highlights from the quarter before handing over to Sabina for a more detailed review of our financial results in Q2 2025 and then to Thijs for an update on our recent commercial activities. We are turning the company around on a path to profitability. We had another record quarter based on revenue with 67 million second sales representing a growth of around 27% compared to Q2 last year. Gross margins came in at 84%. What we are most proud of is the EBIT that came in at record 5.5 million SEC. This includes a reclassification of non-operational FX impact that Sabina will talk more about and a 1.8 million SEC in one offs related to the reorganization. Our cash position was at the solid 100.4 million SEC. Our reorganization plan that we initiated early this year has now been completed. Along with an improved company-wide cost control process, we have managed to find a much healthier cost structure for the company going forward. Our strong EBIT result improved by 20 million SEK from the previous quarter, and we remain confident that we will reach our financial targets that we previously communicated. of 30% annual organic growth, 80% gross margin, and 20% in EBIT margin by 2026. Our updated strategy is being implemented across the organization and is further improving our focus and efficiency in way of working. Our updated strategy is also helping us focus our product development efforts to develop products that solves important clinical problems within our two main strategic customer segments, the clinical genetic labs and the transplantation labs. We have now generated a very exciting and strong product roadmap for the next three years that both better quantifies the opportunities and meets the needs communicated by our customers. As mentioned previously, we strongly believe there are significantly more unmet diagnostic needs that we can address together with our customers and scientific collaborators. We're now starting to see the effects of our recent investments in our diagnostics machinery, and we are eager to start executing our newly developed product roadmap. In addition to our reorganization, we have worked extensively with implementing tools and processes to improve efficiency across the organization. Overall, we now feel that we have an organization that is better cost balanced and is working on solving the relevant problems. And as demonstrated by this quarterly report, this has been done without compromising our growth. I would like to highlight our recent product launches in Q2 2025. As previously announced in late 2024, we achieved IVDR Class D approval from our external regulatory assessment of our divisor RHD product. We then finalized our internal quality processes and enabled us to launch and start shipping the product in early June, we have now demonstrated that we can deliver Class D products end-to-end from development to batch release and that we are well positioned to support the development of any IVD product, regardless of risk class going forward. The visor remains at the scientific forefront in transplantation research. This has further been demonstrated by the development of our latest research product in our transplantation portfolio. The product called HLA loss addresses a very important and currently unmet area of investigation related to malignant disease after stem cell transplantation. and provide researchers with a reliable method to study immune escape mechanisms and patterns that may be associated with treatment resistance. The product represents a unique and premium tool in the segment and further demonstrates our pioneering capabilities in the transplantation research field. The product was launched in late June and we are already getting positive feedback from our customers and early research collaborators. Another launch we had in late June was our genomic blood group typing product. This product represents a tool for typing blood donors in research settings and has the potential to advance the field of transfusion medicine. This next-generation sequencing-based solution enables comprehensive genetic blood typing covering red blood cells, human platelet antigen and human neutrophil antigen systems in a single and streamlined test. DEVICER genomic blood typing empowers research laboratories, transfusion centers, and transplant programs to move beyond the limitation of serology with capabilities for identifying real blood types and studying immune compatibility in research context. Finally, I would like to highlight a few additional activities from the quarter, starting with the MOL-DX submission that we just recently received feedback from. We received a very concrete and valuable feedback on our submission. It was mainly around a bigger sample size, which we already had prepared for in terms of sourcing these samples proactively. Overall, I would say we are pretty pleased with the feedback since we now have a very specific and achievable deliverable to complement the application with to obtain a positive reimbursement decision later this year. As a commercialization strategy, we are in parallel in discussions with partners with commercial capabilities in this field. And you will hear more on this from Thijs later in the presentation. As part of the transplantation strategy, we have an ongoing FDA project, as previously communicated, from the required reproducibility and accuracy studies. And moreover, we recently had a pre-submission meeting with the FDA that confirms that we are on the right track and thus moving forward with the sample collection. More details on the timeline will be communicated later this year. With that, I would like to hand over to Sabina to share more details on our financial results for the Q2 2025.

Thank you, Fredrik. So here let me give you a summary of the financials for the quarter. Revenue for the period April to June came in at 67.4 million SEK compared to a 53.2 million SEK in the quarter of last year. The growth is almost 27% in the quarter and back to historical levels. Thijs will soon go through more about the market dynamics during the quarter. Also going forward, there will always be fluctuations in individual quarters. The trend with strong growth quarter over quarter continues, and we are proud to again present the strongest quarter revenue-wise in the company's history, closing in on the next milestone of 70 million SEC in a single quarter. Our EMEA region remains our biggest market, but the US continues to take market share with a quarter over quarter growth of over 200%. Asia Pacific saw lower sales in the quarter this year compared to last year, But with such small numbers, fluctuation between quarters can be expected. And it should be noted in these tables that Thermo Fisher sales is split between EMEA and US as we shift to both US and European warehouses. Distributor sales showed the strongest growth in the quarter with a major contribution from the transplantation agreement with Thermo. While direct sales showed a softer quarter overall, it is mostly impacted by facing in the Italian market. We did see very strong growth in some of our direct markets, such as the US, UK and Spain. Thijs will cover more details on the markets and the dynamics for our channels shortly. Gross margins came in at 84.2% during the quarter, leveraging the new facility, sales growth, and savings from the reorganization and efficiency programs that we initiated earlier this year. EBIT during the quarter was 5.5 million SEC. I'm also very happy that we can present a positive quarter that shows the effect of the changes we did at the beginning of the year. With a right-sized cost base, we believe that we can fully leverage divisor strength and market potential towards a sustainable profitability within the communicated timeframe of our financial goals. While the majority of the cost for the reorganization was taken in Q1, the P&L for April to June includes 1.8 million SEC in one-offs from those initiatives, as Fredrik mentioned. We can expect to see the new run rate from our savings from Q3 and onwards. I'll also take the opportunity to briefly explain a change in reporting that we initiated in this quarter. In the Q2 report, we have reclassified the currency impact from the internal loan from Divisor AB to Divisor Inc, from operational, where it had been reported previously, to reporting it as the financial item that it is. Therefore, all historical quarters have been updated in the report for comparisons reasons, and the report includes a bridge table where we state the impact on historical quarters for transparency. We closed the quarter with 100 million SEC in cash. The cash flow for the quarter of minus 14.8 million SEC has not yet caught up to the strong EBIT development, but we expect it to do so within a reasonable time period. We will continue to carefully balance investments in our product development activities with thoughtful cash management to ensure a healthy cash position. I continue to feel comfortable with our cash flow and it will turn over the foreseeable period as our focus on profitability continues. And with that, I hand over to Thijs.

Thank you, Sabine, and good morning from Italy. I'm pleased to share several promising highlights from Q2 and why we're confidently excited about what the future holds. Q2, as you heard, was another all time high revenue quarter with 60 million SEC in revenues, which clearly distances itself from the previous all time high of Q4 of last year. As Fredrik mentioned, we launched three new products during the quarter, which all are gaining traction with interest, scheduled demonstrations and even orders already at this point. The past year's investments in infrastructure is already paying off. And since the introduction of our new CRM last year, we have gained new and unprecedented transparency across our commercial funnel, which further enhances our visibility to where our investments in creating leads pays off the most. As of June, we had doubled our leads and even further developed our customer conversion rates, which in turn has increased the number of new customers significantly. In addition to this, we are increasing the number of products sold to each customer while consistently increasing our average selling prices, which contribute to the average revenue per customer increase that we have seen across our segments. This, in combination with our launch momentum, is indeed very promising for the future. The past quarter was strong on the thermal side, but also in North America, where we are gaining momentum. All of this, while our European business remains on track, which I will go through in more detail during the coming slides. Moving on to an update on the partnership with Thermo Fisher. Q2 was good, both revenue-wise and customer-wise. We attended several large trade shows during the quarter together with Thermo Fisher, which bit by bit establishes our products as the golden standard within the community. Both we and Thermo Fisher remains confident in the continued test adoption and revenue growth, and both are expecting that the revenues will be considerably stronger in the second half of the year versus the first half of the year. The FDA pre-submission feedback has been received, as you heard from Fredrik, and we are still on track with the program. More details around this will be given later in the year. North America had a strong quarter and almost triple revenues over the same period last year, driven by sighted and the early momentum in Canada and the US, particularly driven by RHD testing. Later in Q3, we expect one of the largest service providers to commercialize our RHD test across the US, which is naturally a big thing. Partnering for channel coverage remains a preferred strategy and also something we are actively engaging in with our transplantation services related to our ClearLab. As Fredrik mentioned, we received concrete, actionable, and not least doable feedback from our Multi-X submission, which already is being addressed. We remain optimistic about resubmitting and receiving a positive confirmation which in turn will enable to sign up one or several commercialization partners within the US. Cited is following plan and volumes are increasing by the month. Something that is expected to continue throughout the year, which is also positive for the revenue momentum in general. During the quarter, we had a very well-attended webinar focused on our test for cystic fibrosis, together with the prestigious CAP today, which generated a lot of interest and leads. We still today have one of the only available tests that lives up to the updated guidelines from the American College of Medical Genetics and Genomics, the ACMG, recommending screening of 100 variants instead of the previous guideline stating 23 variants. Moving on to Europe, I'm pleased to share that despite the very strong Q1 we had in many markets, we still did well in Q2. As Sabina said, what is holding back our overall growth in direct markets is a softer than expected performance in our largest market, Italy, which grows around 3% on a year-to-date basis. They are, however, up against quite a tough compare as they grew more than 20% same period last year, so H1 of 2021. The funnel, however, for the second half of the year looks very healthy and we continue to win tenders, as you also have seen from the report, and we have no concerns about the healthy and continued growth in our largest market of Italy. We're seeing a solid onboarding of new customers within our genetic labs customer segment, which we expect will accelerate on the back of the new products that we launched just recently. On a year-to-date basis, we have increased the number of buying customers by 16% in Europe, while also increasing our average selling prices. Our position in Europe is gradually building, and I'm confident that our new one-stop-shop strategy will further strengthen this position. We stand on such a solid platform based on our regulatory strength with IBDR and recently cleared our RSD product within the highest classification, Class D. We are increasingly seeing requirements by customers and tenders to have IBDR products available already now today, which will increase further during the years ahead, making us confident that we are in a very strong position to win across various segments and markets in Europe. And with that, I give it back to you, Fredrik.

Thank you, Thijs and Sabina. The theme for 2025 is to leverage our recent investments, focus the organization and turning the company around towards profitability and our financial targets. With all the exciting product launches, internal initiatives and commercial focus, I'm confident that we are now turning the company around and on a good track to achieve these goals as we have set up for 2026. With a more focused and efficient organization, we are positioning Devizor to better serve our customers and patients, as well as our employees and shareholders. August 3rd will be my last day as an interim CEO. I will then hand over to our new CEO, Jan Wallström. I would say the future for Devizor looks very promising, and I'm looking forward to continuing my work in my capacity as a board member. With that, I would like to open up for questions.

If you wish to ask a question, please dial pound key 5 on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key 6 on your telephone keypad. Next question comes from Ludwig Lundgren from Nordia. Please go ahead. Next question comes from Ludvig Lundgren from Nordia. Please go ahead.

Okay, maybe now it works. Hi all, and congratulations on the strong numbers here in the quarter. So first I just wanted to clarify from the prepared remarks on the Moldex feedback. So was this feedback basically a denial of the reimbursement of the transplant trace as it stands today, or is this just a part of the usual reimbursement workflow?

Well, it's a application that has very many parameters and there is a, you know, we could look at the application from sort of, there's a lot of risks and unknowns, what MoldDx would like to see in the end. So I mean, one outcome could be that, yeah, we were fine with this today. That would be sort of the perfect outcome, right? But I would say the second to the best outcome was that you need to complement with more samples. That's a very concrete and focused task for us to do. And that's something that is quite straightforward as a complement to the application.

And maybe I can add that usually only one third of these tech assessments gets a positive reply in the first round. So it was expected.

Okay, understood. More specifically, what is needed before you can reapply for approval? Is it one more clinical trial in the US or anything else?

No, we just need to supplement with additional samples to the study that has already been done.

Okay, great. And then I also wanted to continue a bit on the prepared marks on the RHD test in the US to be commercialized through one of the largest service companies, I think you said. So can you elaborate a bit more on how this test will be offered under this partnership? Will the test be offered as a send out to your lab in the US or will your kits be internally validated?

at these labs right so tyce you can take this yeah for this specific opportunity it's uh the test will be validated uh by the partner and offered by the partner in partnership with device but not as part of our ClearLab. But it's a great achievement by the team. And once we can officially launch and declare who the partner is, I will be very proud to do so. But we are a little bit, a few months early on that.

Okay understood and like for this to generate significant revenue do you also need some reimbursement decision and so on for that or how would that process look?

No, that would lie with the partner. But if you look at what, for example, Latera successfully have been doing is to complement some of their offerings with the RHD and truly have taken up quite a market position within a very short couple of within this year, essentially. And we're seeing quite interest from all the other large service providers in the States to complement their offerings to be on par with what is currently the change in the market. And keep in mind that this market up until less than a year ago was all dominated by prophylactic injections, right? There were no testing happening. So we've been talking about how devices take part of this change. And here we are. And we will be one of those very instrumental testing providers within the States.

Okay, great. Sounds exciting. I'll jump back into the queue.

Next question comes from Ulrich Trattner from DNB Carnegie. Please go ahead.

Thank you very much and good morning and congratulations on the results. And some additional questions here on the sort of reimbursement and development in America. And just as well, sort of how the Thermo Fisher agreement on the transplantation portfolio and especially the solid organs, how will that sort of proceed following reimbursement? Will these also be validated into Thermo Fisher's own labs or will they also be sent to the CLIA lab? How does sort of this strategy now with a service partner in addition How does that resonate with your proceeding with the FDA approval? Will that be able to be expanded post FDA approval of these products? That would be my first question.

Yeah, maybe I can sort of try to answer it in sort of broader terms and then ties you can ship in as well. So I would say there's three ways for us to commercialize our transplantation products in the US. The first one is through the research use only kits through Thermo. And what happens is that Thermo reach out to customers and saying that we can sell the kits, but the customers needs to make their own validations of the kits. And that's ongoing. The other way is to go through FDA and then we do the validation and we do it once. And then we can reach out to customers, say the product is already validated. Now it's more of a matter of getting the customer up and running in terms of training and maybe a small subset of samples just to make sure it works. It's a much faster implementation from a customer perspective to get up and running on the products. The third one is to go through our CLIA lab. And although we say in our strategy in terms of transplantation that we're trying to get the customers to run the samples on their own instead of sending out samples. And that said, there's going to be a portion still of the total market that still prefers to send out samples and then we should have the capabilities to help out through our CLIA lab. So that's the three paths that we see we can pursue in the US. So Thijs, maybe you can extrapolate if you like.

Yeah, I think you covered it and we'll see if it answers. But maybe just a few additional comments. Keep in mind that Currently, the research use only product is under contract with Thermo Fisher. We have retained exclusive rights for anything that relates to the product as a service within the States, which is not to be underestimated. And lastly, with regards to the FDA engagement, although we are collaborating with Thermo Fisher on bringing the product through FDA, that final FDA cleared product still resides exclusively with the advisor, as we have not made any decision on who should be the commercialization partner at that given point in time.

Great. And a follow-up question on Thermo Fisher and the agreement. You received a large order in Q4. Obviously, it had some destocking effect for Q1, but now it seems like they're ramping up their order intake again. Can we sort of interpretate this sort of ramping up of orders that the Q4 order is not part of inventory anymore. It's been sent out to customers and been used on customers. Is that a fair interpretation?

It would be speculation because we honestly don't know either. But we have seen obviously a recurring ordering pattern from Thermo during the quarter. But whether we can confirm that that means that the supply from Q4 has been depleted would be speculation. But the pattern increases for sure. Okay.

Great, thank you. And on the Americas development, and you touched upon these five with CITED and already awarded RHD contracting in Canada, but can you give us some type of granularity in terms of revenue contribution here in the second quarter? And I noted that you mentioned that CITED is expected to sequentially ramp up in the sort of later part of the year. And in addition to CITED, because these are tests not devised or developed tests from CITED, how much capacity do you have in your CLIA lab at the moment to ramp up, especially given comments about the possibility for you sending out and selling transplantation products for your CLIA lab? And I guess given the fact that you are seeking reimbursement for several products these would also be included into the CLIA lab reimbursement. So I guess just how should we view this?

In broader strokes, then there will be an increased contribution in general from across North America in second half of the year versus first half. And that obviously comes from not only CITES, but also our RHD commercialization, both in Canada, where we're expecting Canadian blood services to start clinical utilization. And then, obviously, in the States, we will start commercializing with the partner, as mentioned. Cyted will increase, notably, also during the second half of the year. And interestingly enough, we're taking in quite some dialogue with similar kind of companies like Cyted, who wants to more or less replicate what we have done together with Cyted. So there are plenty of opportunities. And when it comes to the capacity, we have no constraints on capacity within the lab. And once we get reimbursement and we sign up the commercialization partners, that will also contribute quite significantly to revenue contribution from the onset of that approval. But there's no, at this point in time, any consideration or constraints when it comes to CLIA lab capacity.

Okay, great. And last question on my end before getting back into the queue. EMEA development, you talked about 16% customer increase year-over-year and increased average selling price. Did you dare to comment on Like price increases or it's a product mix function where the genetic portfolio obviously carries or the MGS portfolio obviously carries a higher selling price or is there sort of general price increase on your end?

We have increased, ever since I joined, double digit on prices every year. And that's something we are continuously doing. So that can also be expected that there will be a price increase for 2026 coming in. And obviously that has an impact when we look at the average selling prices. And not anybody can successfully deliver on that. continue to grow customer base. And that's what I'm particularly proud of about the divisor team and what they've been doing is as part of the new strategy, obviously we want to, we know that door into the genetic labs is already open. It's not too difficult for us to go in and sell additional new products. That's key thing we are working on. And obviously that contributes to the average revenue by customer also, right? In addition to the price contributions that we're actively utilizing.

Just to follow up on that. Double-digit price increases, 16% customer growth, as well as increased volume per customer itself. Would that not sort of imply that your financial targets look a little bit too conservative and even sort of your most mature market should be able to grow well above your financial targets.

think that speculation would perhaps defer back to Fredrik or Sabine if they want to comment on specifically the targets but what I can answer to is obviously assuming that we issue a price increase of 10 it's not usually what goes straight to the actual selling prices because quite a bit of our business is tied into long-term contracts that has certain boundaries for how much you can increase prices. So that would only impact list prices and how we would negotiate with new customers. But that's the strategic way of working with increasing your value base over years. That's one thing and why you can't make that correlation of double digit price increases to growth. But generally, the business is growing really, really well and all markets are incrementally growing. The only thing holding back our growth in direct markets in this quarter is Italy. But they also had a fantastic first half of 2024. which in a mature market where you're the market leader in many of the segments, it's difficult, right, to continue to grow more than 20%. So that's why we see these facings that are happening. I hope that answered. Okay.

Yeah, absolutely. Thank you very much, Thijs. And thank you, Fredrik and Sabine as well. And I'll get back into the queue.

Next question comes from Philip Weiberg from Pareto Securities. Please go ahead.

Hi, good morning. I've got a few questions here, but I'll take them one by one. So first, I would just like to follow up on the distributor sales here. And I know you're quite hesitant normally in giving some guidance on that. But excluding FX, it's in line with the Q4 last year, which was really strong. So I'm just curious, you know, of the one of effects and how temporary this is. Is it possible for you to give any sort of guidance or any indication of how strong it was and what to expect now going forward for the remainder of the year?

Thijs, do you want to comment?

Yeah, I can comment. Well, the good thing is that within distributors, it's not only Thermo Fisher. We have a very healthy distributor business that is being run exactly as it should be. And if you look at, for example, the European part, a bit broader than that one, we had 40% growth in that specific region during the quarter. So it's a mix. And then as you saw, APAC was a little bit softer, which is only distributor channel also, right? So it is a mix. I can't go closer. As you know, we don't disclose partner sales.

All right. Okay. It's worth a try, I guess. But all right, I'll move on to the next one. But around the newly launched test here, you said that you received some positive feedback. So is it possible to just share some more details around the traction that you've had now, then also around what the feedback has been?

Sure. So I think if we look at the HLA loss that we consider a very much a premium product and from various perspective, there is not many other alternatives and the ones that there is, we can see that we're basically has a superior performance. And moreover, we were looking at the customer segment that is, I would say, not the traditional sort of old school genetic labs. These are labs that I would say working in the transplantation field with a little bit more sort of research forefront and has, I would say, another sort of They're not as sensitive on price. This is a product that has a huge impact on people's lives. And we can, of course, take advantage of that from a sort of pricing perspective. And this is, I would say, a product that we're really proud over. highlights the sort of our scientific forefront from the visor in the transplantation research field. Yeah, so that has been very well received overall since the launch, I would say.

Okay, and in terms of your product portfolio, how would you rank these pests like according to the potential that they have?

Well, we don't communicate that, I would say, but I mean, look, so I think that you should look at this from a capability perspective that if we are now focusing our product portfolio efforts on the two customer segments, the clinical genetic labs and the transplantation labs. And we are getting a sort of a focused effort across the organization all the way from our research and development groups all the way to our commercialization where we have sort of boots on the ground and a ongoing discussion with these customers. So as Thijs mentioned, we're going to continue developing product in these fields and continue to feed the customers that we have already up and running with more exciting products like this one.

And maybe, Philip, just give you a bit more guidance, because here, obviously, when you look at the patient population, if you're trying to model it a little bit, this is usually as a reflex test to the chimerism most often. So it won't be top-selling product, but it will be a very significant contributor, and it will be an additional product into the mix that we can offer transportation laboratories, which is not to be underestimated. If we move to the genomic blood typing product, that's also truly unique. That's about changing the market also. Now we can offer a lot more granularity and detail on the specific patient blood typing. And that could certainly be quite transformative within those fields. And here we have seen interest from Stockholm, interest from both Canadian Blood Services and Hema Quebec. So all these blood centers are picking up interest in this product, which is very, very interesting to follow.

Okay, thank you very much. And then just the last question here, perhaps to Sabina. around the cash flow so so ebit is turning you know positive now but but you're also capitalizing a lot so the cash flow is still negative and and now we have a cash position at 100 million so i'm just trying to to get some more sense in when when you're expecting this to turn and is it just continuing contingent on continued growth sabina you want to take this one yes and i

In a growing company, I would say cash flow is one of the priorities for the CFO and so for me as well. We're not guiding specifically on when we expect our cash flow to turn. Apart from that, we do expect it to. And we will continue to invest into our product portfolio. We have a very strong roadmap. But all the forecasts and the internal strategies and plans we have is a balance between the growth that we expect to see in the company and the investments that we will and can make. So there are many handbrake opportunities and several opportunities to push the gas developed depending on how our growth on the sales side continue and how we decide to utilize that money, as well as our run rate on the cost side. Did that answer your question?

Well, I think it was somewhat helpful. Thanks.

Thank you.

That's all from me.

Next question comes from Oscar Bergman from Redeye. Please go ahead.

Hello everyone and congrats on a very strong report. Nice to see. I got a few questions. The first one, I think maybe this one was already discussed in the Q&A session, but could you elaborate on what you see ahead in Italy for the second half of this year? Because direct sales is so dependent on how things are progressing on that market.

Yeah, Thais take that one.

Yeah. Well, historically, Italy has always been growing modest, very high single or modest double. And we're not seeing anything should change in that respect. And we just announced, as we also disclosed in the report, another very sizable tender that in itself has 10% organic growth. So we do expect Italy to rebound in the second half of the year.

And then I know that in the previous years you have talked a lot about the conversion of distributor markets to direct markets, but this seems to have been given a less focus in the past maybe two years. Is this something that you agree with? And should we assume that this is not a key focus area for you?

I mean, look, I think it's part of how we communicate what Devizor is all about. It's not a company that likes to highlight when we convert, how we convert customers. It's more of a sort of what we deliver as a scientific and diagnostic company and how we can help people. But I wouldn't say that the strategy on the conversion has changed, maybe just the communication around it.

Can you then just elaborate on how this has progressed in the last 12 months or so?

Thijs, do you want to comment on the specifics?

Yeah, I can do that. I mean, as you said, we converted some three years ago, quite a number of markets, right? And going direct is also an investment, right? So we want to make sure that we keep the focus on where we are currently playing ball and in our direct business. And so those markets remains to be the the large european markets and north america and until the day where we have truly delivered on on those and we can afford investing elsewhere we will do so but apac naturally there are some of the the eastern european markets that are very attractive markets to be open and converted into direct sales but it's not something that we are diluting our efforts uh with at this point in time and i wouldn't expect that to change within probably this year, next year, but that's a bit of an internal consideration.

Okay, okay. And then I have a question for you Sabine also. I was wondering if you can elaborate on the investments in intangibles and how we should expect this to develop in the coming quarters.

As previously, we are careful and guiding on investment strategy and as I answered to the other question, is very much dependent on preserving our cash flow as well. But yes, we have quite strong investments in intangible assets during this first six months of the year. But we will continue to invest in the roadmap. We have been quite successful in improving our project management, meaning that more of funds spent are capitalized compared to in 2024. And I would expect to see a similar trajectory during the rest of the year.

Okay. Are there any specific milestones ahead that could render a decrease in investments?

Not anything that we are specifically planning. We continue to be a growth company and we will continue to expand our product portfolio. We have some very interesting products ahead of us, including the FDA that we will run in parallel with the development projects. So I think you will need to make some assumptions on your own regarding the size of the investments. But that's about how much we're guiding right now.

Okay. And then just a final question. I mean, following a presumed FDA approval for Accept, Do you know what might be required for you to broaden the approval to other sorted organs?

Yeah, Thijs, do you want to chip in on that? I think that, you know, we will be a bit careful on sort of guiding beyond the current application. But we have, of course, a good sense on the requirements. Thijs, maybe you want to share some details on that?

Yeah, just briefly. I mean, obviously it's serious business, right? So the FDA would want to see quite a rigorous clinical evidence package, right? Just like the one we're building for the kidney. So you can expect that we would have to build and go through similar efforts as we're currently working on, focusing on kidney.

Okay. And it's a follow-up question. Do you expect that type of fissure would be astringent on having that documentation and claims before potentially venturing into heart, liver, lung?

As you've seen from publications, there are several engagements already outside kidney, but on a research basis that is driven by Thermo Fisher. So evidence is already being built, but in a research setting.

Okay, and it's the final question, and I suspect you don't have the details regarding this, but do you know sort of the mix of soiled organs that taro fish is using except for today if it's solely a kidney, for example?

I don't have a concrete answer to that, aside saying it's focused very much on kidney, which is the lead focus. But there is quite a scientific engagement program going on that looks beyond kidney and into heart, liver and lung also.

Okay, perfect. Thanks.

Next question comes from Ludvig Lundgren from Nordia. Please go ahead.

Yes, I just had a few follow-ups on costs here. So there's been significant changes in OPEX in the last few years, partly from the move to new premises and now with this restructuring program making year-over-year comparables maybe less relevant. So I just wonder, looking you know a bit out in the mid to long term what OPEX growth rates are reasonable to expect for the business from this newly lower established cost base here in Q2 like what would you say is the reasonable organic OPEX growth into 26 for example

Yeah, Sabine, I can chip in. But I would say that in general, we're feeling very comfortable with the sort of setup we have right now. We've done your facilities, the new leadership in our operation active groups, we have a sort of a way of working that looks like we're gonna be able to in more efficient and more streamlined way delivering more products with the same or as you can see here, even lower headcount. So, I mean, we have already improved a lot in the way of working, but of course, there's a lot of efforts ongoing to further improve our efficiency and also our cogs. So that we're looking forward to communicate on later. But Sabina, maybe you want to comment as well.

I think you covered that well.

Okay. Yeah, great. Very helpful. And do you like to expect any restructuring costs in H2 as it looks today?

uh no not really we we've uh as it as we when we started the the year earlier this year we we we had a plan and we feel that we executed that um so uh at the moment we we are um finding a company that is much more balanced and we're looking forward to just continue to work on our diagnostic machinery to get more products out more efficiently.

Okay, great. And then I just had a final one because I saw Moldex published a new proposal for the LCD covering post-transplant testing last week, restricting the number of post-transplant tests to four for kidney in the first year, I think. So I just wanted to hear your view on this change and also whether this new LCD could affect the reimbursement timeline in any way for you.

Yeah, I mean, it's a little bit early days to comment, but sure. I mean, we looked at it. I think that you can look at it from different perspective. I would say that for us right now, it has a minimal impact. When we look at sort of the overall uh opportunity in terms of the market size um i think when we communicated this on our sort of broader capital market day i think we had calculated the test of to be six the first year instead of four that said if we if we read what what care dx um one of the competitors uh they they claim that they are not even at four um with the current ongoing business so i wouldn't say that this is a um you know it it it has as marginal effects i would say for us um maybe we could say that it it adds a bit of um i would say um it it unpredictable in the business that things like this happens. But for now, I think the clarity is it's not a bad thing. And, you know, again, minimal impact from our perspective at the moment.

Maybe I can just add, as you saw from the CD, there's clear confirmation of the necessity and the relevance of CFDNA within this field. So I think regardless of the number of monitoring, keep in mind this is still a draft, but the scientific relevance is being established, which is only going to benefit us and the field within the industry.

Great. Thank you very much.

As a reminder, if you wish to ask a question, please dial pound key 5 on your telephone keypad. There are no more questions at this time, so I hand the conference back to the speakers for any closing comments.

Yeah, so again, thank you everyone for joining our call today. We certainly feel a very good momentum and energy in the company today with many exciting opportunities ahead of us. So thank you everyone for calling in.