Welcome to the Devyser Diagnostics Q2 report 2025 presentation. During the questions and answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. Now, I will hand the conference over to the speakers: CEO Fredrik Dahl, CFO Sabina Berlin, and CCO Theis Kipling. Please go ahead.
Good day and welcome to Devyser Diagnostics Q2 2025 earnings call. I'm Fredrik Dahl, I'm the Acting CEO of Devyser , and I 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 Theis 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 Theis 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 SEK 67 million in 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 a record SEK 5.5 million. This includes a reclassification of non-operational FX impact that Sabina will talk more about and SEK 1.8 million in one-offs related to the reorganization. Our cash position was at a solid SEK 100.4 million. 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 SEK 20 million 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 solve 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. 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 Devyser 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. Devyser 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 provides 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 Typing solution. 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. Devyser Genomic Blood Typing empowers research laboratories, transfusion centers, and transplant programs to move beyond the limitation of serology with capabilities for identifying rare 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 MoDX submission that we just recently received feedback from.
We received 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 pre-actively. 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 Theis later in the presentation. As part of the transplantation strategy, we have an ongoing FDA project, as previously communicated, and we are in the process of collecting samples from the required reproducibility and accuracy studies.
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. Here, let me give you a summary of the financials for the quarter. Revenue for the period April to June came in at SEK 67.4 million compared to SEK 53.2 million in the quarter of last year. The growth is almost 27% in the quarter and back to historical levels. Theis 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 SEK 70 million in a single quarter. Our EMEA region remains our biggest market, but the U.S. 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. It should be noted in these tables that Thermo Fisher sales are split between EMEA and U.S. as we ship to both U.S. 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 a phasing in the Italian market. We did see very strong growth in some of our direct markets, such as the U.S., UK, and Spain. Theis 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 SEK 5.5 million. 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 Devyser 's 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 SEK 1.8 million 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 Devyser AB to Devyser 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 comparison reasons, and the report includes a bridge table where we state the impact on historical quarters for transparency. We closed the quarter with SEK 100 million in cash. The cash flow for the quarter of minus SEK 14.8 million 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 I will turn over the foreseeable period as our focus on profitability continues. With that, I hand over to Theis.
Thank you, Sabina, 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 SEK 60 million 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 are 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 pay 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 Thermo 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 remain 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 tripled revenues over the same period last year, driven by Cited and the early momentum in Canada and the U.S., particularly driven by our RHD testing.
Later in Q3, we expect one of the largest service providers to commercialize our RHD test across the U.S., which is naturally a big thing. Partnering for channel cover remains a preferred strategy and also something we are actively engaging in with our transplantation services related to our CLIA lab. As Fredrik mentioned, we received concrete, actionable, and not least doable feedback from our MoDX submission, which already is being addressed. We remain optimistic about resubmitting and receiving a positive confirmation, which in turn will enable us to sign up one or several commercialization partners within the U.S. 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% the 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 IVDR and recently cleared our RHD product within the highest classification, Class D. We are increasingly seeing requirements by customers and tenders to have IVDR 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. With that, I'll give it back to you, Fredrik.
Thank you, Theis 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 Devyser to better serve our customers and patients, as well as our employees and shareholders. August 3rd will be my last day as Interim CEO. I will then hand over to our new CEO, John Wahlström. I will say the future for Devyser 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 five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial pound key six on your telephone keypad. Next question comes from Ludvig Lundgren from Nordea. Please go ahead.
Okay, maybe now it works. Hi all, and congratulations on the strong numbers here in the quarter. I just wanted to clarify from the prepared remarks on the MoDX feedback. 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?
It is an 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 in what MoDX would like to see in the end. One outcome could be that, yeah, we were fine with this today. That would be the perfect outcome, right? 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.
I can add that usually only one third of these tech assessments gets a positive reply in the first round. It was, you know, expected.
Okay, understood. More specifically, what is needed then before you can reapply for approval? Is it one more clinical trial in the U.S. or anything else?
No, we just need to supplement with additional samples to the study that has already been done.
Okay, great. I also wanted to continue a bit on the prepared remarks on the RHD test in the U.S. to be commercialized through one of the largest service companies, I think you said. 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 U.S., or will your kits be internally validated at these labs?
Right. Theis, you can take this.
Yeah, for this specific opportunity, the test will be validated by the partner and offered by the partner in partnership with Devyser , but not as part of our CLIA lab. It is a great achievement by the team, and once we can officially launch and declare who the partner is, you know, I will be very proud to do so. We are a little bit, a few months early on that.
Okay, understood. 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, and that would be aligned with the partner, but if you look at what, for example, Laterra successfully have been doing is to complement some of their offerings, right, with the RHD and truly have taken up quite a market position within a very short couple of, you know, within this year, essentially. 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. 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. We've been talking about how Devyser has taken part of this change, and here we are, and we will be one of those very instrumental testing providers within the states.
Okay, great. That sounds exciting. I'll jump back into the queue.
Next question comes from Ulrik Trattner from DNB Carnegie. Please go ahead.
Thank you very much, and good morning, and congratulations on the results. I have some additional questions here on the sort of reimbursement and development in America. Just as well, how the Thermo Fisher agreement on the transplantation portfolio, and especially the solid organs, how will that 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 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 broader terms, and then Theis, you can chip in as well. I would say there's three ways for us to commercialize our transplantation products in the U.S. The first one is through the research use only kits through Thermo . What happens is that Thermo reaches out to customers and says that they can sell the kits, but the customers need to make their own validations of the kits. 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 and say that 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 very much 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. 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, 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. That's the three paths that we see we can pursue in the U.S. Theis, maybe you can extrapolate if you like.
Yeah, no, I think you covered it, and we'll look 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 U.S., which is not to be underestimated. 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 Devyser , as we have not made any decision on who should be the commercialization partner at that given point in time.
Great. 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 interpret 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. We have seen obviously a recurrent ordering pattern from Thermo during the quarter. Whether we can confirm that that means that the supply from Q4 has been depleted would be speculation. The pattern increases for sure.
Okay, great. Thank you. On the Americas development, 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? I noted that you mentioned that Cited is expected to sequentially ramp up in the later part of the year. In addition to Cited, because these are our tests, not Devyser-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 through your CLIA lab? I guess given the fact that you are seeking reimbursement for several products, these would also be included into the CLIA lab reimbursement. How should we view this?
In broader strokes, there will be an increased contribution in general from across North America in the second half of the year versus the first half. That obviously comes from not only Cited, but also our RHD commercialization, both in Canada, where we're expecting Canadian Blood Services to start clinical utilization, and in the U.S., we will start commercializing with the partner, as mentioned. Cited will increase notably also during the second half of the year. Interestingly enough, we're taking in quite some dialogue with similar kind of companies like Cited, who want to more or less replicate what we have done together with Cited. There are plenty of opportunities. When it comes to the capacity, we have no constraints on capacity within the lab.
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. There is no, at this point in time, any consideration or constraints when it comes to CLIA lab capacity.
Okay, great. 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. Do you dare to comment on like price increases, or it's a product mix function where the genetic portfolio obviously carries or the NGS portfolio obviously carries a higher selling price, or is there sort of general price increase on your end?
We have increased, since I joined, double-digit on prices every year, right? That's something we are continuously doing. That can also be expected, that there will be a price increase for 2026 coming in. Obviously, that has an impact when we look at the average selling prices. Not anybody can successfully deliver on that, right? Continue to grow customer base. That's what I'm particularly proud of about the Devyser team and what they've been doing. 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 a key thing we are working on. Obviously, that contributes to the average selling, the average revenue by customer also, right? In addition to the price contributions that we're actively utilizing.
Okay, just to follow up on that, double-digit price increases, 16% customer growth, as well as increased volume per customer itself, would that not imply that your financial targets look a little bit too conservative and even your most mature market should be able to grow well above your financial targets?
I think that's speculation. I would perhaps defer back to Fredrik or Sabina if they want to comment on specifically the targets. 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 have certain boundaries for how much you can increase prices. That would only impact list prices and how we would negotiate with new customers. That's the strategic way of working with increasing your value base over years. That's one thing and why you can't, you know, make that correlation of double-digit price increases to growth. Generally, the business is growing really, really well, and all markets are incrementally growing, right? The only thing holding back our growth in direct markets in this quarter is Italy, right?
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%. That's why we see these phasings that are happening. I hope that answered.
Okay. Yeah, absolutely. Thank you very much, Theis, and thank you, Fredrik and Sabina as well. I'll get back into the queue.
Next question comes from Filip Wiberg from Pareto Securities. Please go ahead.
Hi, good morning. I've got a few questions here, but I'll take them one by one. Firstly, I would just like to follow up on the distributor sales here. I know you're quite hesitant normally in giving some guidance on that, but excluding effect, it's in line with the Q4 last year, which was really strong. I'm just curious, of the one-off 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?
Theis, do you want to comment?
I can comment. The good thing is that it's within distributors, it's not only Thermo Fisher . We have a very healthy distributor business that is being run exactly as it should be. If you look at, for example, the European part, a bit broader than maybe that one, we had 40% growth in that specific region during the quarter. It's a mix. As you saw, APAC was a little bit softer, which is the only distributor channel also, right? It is a mix. I can't go closer, as you know, we don't disclose partner sales.
All right. It's worth a try, I guess. I'll move on to the next one. Around the newly launched tests, you said that you received some positive feedback. Is it possible to share some more details around the traction that you've had now, and also around what the feedback has been?
Sure. I think if we look at the HLA Loss, that we consider very much a premium product. From various perspectives, there are not many other alternatives, and the ones that there are, we can see that we're basically at superior performance. Moreover, we're 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 are working in the transplantation field with a little bit more sort of research forefront and have, 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. This is a product that we're really proud of and highlights our scientific forefront from Devyser in the transplantation research field.
That has been very well received overall since the launch, I would say.
Okay, in terms of your product portfolio, how would you rank these tests according to the potential that they have?
I would say, but I mean, look, so I think that you should look at this as 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 an ongoing discussion with these customers. As Theis Kipling mentioned, we're going to continue developing products in these fields and continue to feed the customers that we have already up and running with more exciting products like this one.
Maybe Philip, just to 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. It won't be a 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 transplantation laboratories, which is not to be underestimated. If we move to the Genomic Blood Typing product, you know, that's also truly unique. That's about changing a market also with a lot more, now we can offer a lot more granularity and detail on the specific patient blood typing. That could certainly be quite transformative within those fields. Here we have seen interest from Stockholm, interest from both Canadian Blood Services and Héma-Québec.
All these blood centers are picking up interest in this product, which is very, very interesting to follow.
Okay, thank you very much. Just the last question here, perhaps to Sabina, around the cash flow. EBIT is turning positive now, but you're also capitalizing a lot. The cash flow is still negative, and now you have a cash position at SEK 100 million. I'm just trying to get some more sense in when you're expecting this to turn, and is it just contingent on continued growth?
Sabina, you want to take this one?
Yes. 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. 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 are a balance between the growth that we expect to see in the company and the investments that we will and can make. There are many handbrake opportunities and several opportunities to push the gas develop depending on how our growth on the sales side continues and how we decide to utilize that money, as well as our run rate on the cost side. Did that answer your question?
I think it was somewhat helpful at least. Thanks.
Thank you.
Yeah, 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, you know, direct sales is so dependent on how things are progressing on that market.
Yeah, Theis, you take that one.
Historically, Italy has always been growing, you know, modest, very high single or modest double. We're not seeing anything short change in that respect. We just announced, as we also discussed in the report, another very sizable tender that in itself has 10% organic growth. We do expect Italy to rebound in the second half of the year.
In previous years, you've talked a lot about the conversion of distributor markets to direct markets. This seems to have been given less focus in the past maybe two years. Is this something that you agree with? Should we assume that this is not a key focus area for you?
I think it's part of how we communicate what Devyser is all about. It's not a company that likes to highlight 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. 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?
Theis, 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? Going directly is also an investment, right? We want to make sure that we keep the focus on where we're currently playing ball and in our direct business. Those markets remain to be the large European markets and North America. Until the day where we have truly delivered on those and we can afford investing elsewhere, we will do so. APAC, naturally, there are some of the Eastern European markets that are very attractive markets to be opened and converted into direct sales. It's not something that we are diluting our efforts with at this point in time. I wouldn't expect that to change within probably this year, next year. I feel like that's a bit of an internal consideration.
Okay. I have a question for you, Sabina, 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. As I answered to the other question, it's very much dependent on preserving our cash flow as well. Yes, we have quite strong investments in intangible assets during these first six months of the year. We will continue to invest in the roadmap. We have been quite successful in improving our project management, meaning that more of the funds spent are capitalized compared to in 2024. 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 project that we will run in parallel with the development projects. I think you will need to make some assumptions on your own regarding the size of the investments. That's about how much we're guiding right now.
Okay. 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 solid organs?
Yeah, Theis, 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. We have, of course, a good sense on the requirements. Theis, maybe you want to share some details on that?
Yeah, just briefly. I mean, obviously, it's serious business, right? The FDA would want to see quite a rigorous clinical evidence package, right? Just like the one we're building for the kidney. You can expect that we would have to build and go through similar efforts as we're currently working on, but focus on kidney.
Okay. Just a follow-up question on that. Do you expect that Thermo Fisher would be as stringent on having that documentation and claims before potentially venturing into heart, liver, lung?
I think we have, as you've seen from publications, there are several engagements already outside kidney, right? On a research basis, it's driven by Thermo Fisher . Evidence is obviously already being built, right? In a research setting.
Okay. Just a final question. I suspect you don't have the details regarding this, but do you know sort of the mix of solid organs that Thermo Fisher is using except for today? Is it solely a kidney, for example?
I don't have a concrete answer to that, aside from saying obviously it's focused very much on kidney, which is the lead focus. There's 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 Nordea. Please go ahead.
Yes, I just had a few follow-ups on costs here. There have 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. I just wonder, looking 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. What would you say is the reasonable organic OpEx growth into 2026, for example?
Yeah, Sabina, 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 with our new facilities, the new leadership in our operation groups. We have a sort of a way of working that looks like we're going to be able to, in a more efficient and more streamlined way, deliver more products with the same, or as you can see here, even lower headcount. 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 costs. We're looking forward to communicate on that later. Sabina, maybe you want to comment as well.
I think you covered that well.
Okay, great. Very helpful. Do you expect any restructuring costs in H2 as it looks today?
No, not really. When we started the year, early this year, we had a plan and we feel that we executed that. At the moment, we are 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. I just had a final one because I saw MoDX 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. 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 a different perspective. I would say that for us right now, it has a minimal impact. When we look at sort of the overall opportunity in terms of the market size, I think when we communicated this on our sort of broader capital market day, I think we had calculated the test to be six the first year instead of four. That said, if we read what CardiX, one of the competitors, they claim that they are not even at four with the current ongoing business. I wouldn't say that this is, you know, it has marginal effects, I would say, for us.
Maybe we could say that it adds a bit of, I would say, unpredictable in the business that things like this happen. For now, I think the clarity is it's not a bad thing. You know, again, minimal impact from our perspective at the moment.
Yeah, maybe I can just add, I mean, as you saw from the LCD, there's clear confirmation of the necessity and the relevance of cfDNA within this field, right? I think regardless of the number of monitoring, keep in mind this is still a draft, right? 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 five 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.
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. Thank you everyone for calling in.