Welcome to Devyser Q3 2026 report presentation. We will begin with a presentation from the company speakers, CEO Jan Wahlström and CFO Niklas Axelsson. Following the presentation, we will open up for questions. To ask a question, press star five on your telephone to enter the queue. When it is your turn to speak, press star six to unmute. I will now hand over to CEO Jan Wahlström. Please go ahead.
Good morning and welcome to Devyser's Q3 2026 earnings call. My name is Jan Wahlström. I am the CEO of Devyser and would like to thank everyone for joining our call today. On the call today, we have, in addition to me, also our new CFO, Niklas Axelsson. Welcome, Niklas, to your first quarter report with Devyser, and good to have you on the team.
Thank you, Jan, and it is great to be here.
I will start with a short summary of highlights from the quarter before handing over to Niklas for a more detailed review of our Q3 financial results. Thereafter, we will go through an update on our recent commercial activities. Essentially, the headline for our Q3 is that we have had a materially improved profitability. Looking at the Q3 highlights, considering the earlier inventory buildup effect at our largest distributor and its impact on Q2 and Q3, we had a solid underlying sales performance this quarter. Moreover, after the one-off inventory effect in Q2, our gross margin returned to a healthy 83%. Positive as well is that our enhanced organizational efficiency, in which cost discipline has been a central part, is becoming visible in our financials. Our EBIT increased significantly in the quarter, and Q3 2026 represents our sixth quarter in a row with a positive EBIT.
This, in other words, on our improved profitability, combined with a strong focus on cash generation, has also improved our cash flow, which is encouraging. Commercial highlights during the period includes the launch of One Lambda Devyser Chimerism Plus, together with Thermo Fisher, the signing of our first Illumina reagent rental agreement, a strengthened leadership team with Torben Thölix as our new CCO on board, a recently tender win in Italy, as well as the recent news regarding the expansion of scope for our transplant test to include heart and lung, items that we will get back to later in the presentation. As highlighted in the slide, we have generated about SEK 182 million in sales year- to- date, with growth driven by the NGS product launches, strong hereditary performance, particularly in the U.S., as well as a continued strengthening position in Italy.
Given the situation with our largest distributor and its previous buildup in inventory that has affected our total sales level since Q2, sales excellence in our other areas is a key priority and something we are working hard on. As we mentioned in our previous quarterly updates, we are continuing with the ongoing MolDx application for our post-transplant kidney test as a service in the U.S.. Since the latest application, more clinical data has been added, and from a timing perspective, we are expecting an outcome before the end of the year. Separately, our FDA project in transplantation continues as planned. With that, I would like to hand over to Niklas to share more details on our financial results for the third quarter 2026.
Thank you, Jan. As mentioned, it is great to be here. I will now continue with a summary of the financials for Q3. Revenue for the quarter came in at SEK 59.7 million compared to SEK 56.4 million in the same quarter last year. From growth perspective, this corresponds to 5.8% with limited FX impact in the quarter. Year- to- date, our revenue corresponds to SEK 182 million compared to SEK 179 million for the first nine months last year. Looking at our quarterly sales, which is indicated in the graph here, where you can see our rolling 12 months of net sales, you will find that the trajectory changed somewhat upwards again after weak Q2, and now corresponds to SEK 253 million.
As you can see from the graph, we have had minor bumps in our trajectory in the past, and we are working hard to ensure that it will return to normalized growth rates again, looking ahead.
From a regional perspective, you will find in the table here that North America was the region most impacted by the lower distributor orders in this quarter. However, hidden in these numbers is continued strong growth in our hereditary portfolio, as well as for the CLIA lab. Europe, Middle East, and Africa was also impacted by the lower order intake on the distributor side, but the hereditary portfolio continued to grow with rolling 12 months sales in line with our expectations. Worth noting also is that most of our sales subsidiaries in our direct markets are performing well. Last but not least, in Asia Pacific, we accomplished a high growth corresponding to 33% over the quarters, although starting from a low base. From a channel perspective, you will find that our direct sales in Q3 generated 6% growth in the quarter compared to last year.
Italy makes up a large portion of our direct sales, and with their strong market position, their sales growth is lower in the hereditary field, which has a considerable impact on the total growth rate for the segment. Other markets are growing faster, with several regions reaching 25% growth or more. Distributor sales were, as previously mentioned, impacted by a single distributor this quarter, similarly to what happened in Q2. Other distributor markets, particularly outside Europe, are growing at a high rate, as exemplified by the recently mentioned growth in Asia Pacific, corresponding to 33%. From a gross margin perspective, we now have the one-off inventory impact in Q2 out of the way, and consequently, the gross margin came in at a healthy 83% for the quarter.
Operational efficiency and pricing strategies to optimize our gross margin have been key focus areas and will continue to be so going forward. From an EBIT perspective, we are very happy with an outcome of SEK 7.1 million for the period compared to SEK 1.3 million the same quarter last year. This represents the sixth consecutive quarter with a positive EBIT, and a key driver has been the increased focus on operational efficiency. Our focus on optimized resource allocation and cost containment will continue, and for the first nine months, we have operated at a cost level considerably lower than that of the corresponding period last year. Last but not least, a few words regarding our cash position. We closed the quarter with SEK 89 million in cash, which is the highest since Q2 2025. Worth noting is that this does not include any credit from SEB.
Moreover, our cash flow from operating activities corresponding to SEK 22 million, to be compared to SEK -0.5 million for the corresponding period last year. A key driver to this improvement is the increased profitability in itself that we spoke about a few slides ago, and also, our working capital considerations are key focus areas, and we will continue to work on this going forward as well. With this, I would like to hand it over back to you, Jan.
Thank you, Niklas. I will now share some commercial highlights from the quarter. Our Q3 proved to be an eventful period marked by solid sales performance, particularly in hereditary. We experienced high growth in several markets, and especially in the U.S. with our direct business. During the quarter, we launched One Lambda Devyser Chimerism Plus together with Thermo Fisher, and we already see good customer comments on that product. Our first Illumina reagent rental agreement was signed in Italy, and during the quarter, we also strengthened our leadership team with a new CCO in place. Moreover, another tender was won in Italy, with the test volumes expected to double. Last but not least, we are expanding the scope of our One Lambda Devyser Accept cfDNA, to include heart and lung transplant patients, in addition to the already existing kidney scope. A little bit more detail into the reagent rental agreements.
As presented in our previous quarter report, our view is that the reagent rental agreement with Illumina represents attractive opportunities for Devyser. Several potential customers of ours are searching for an opportunity like this, and we believe that many deals will materialize for us in this agreement. The reagent rental model is a proven business model in our market, and we believe that it will be a key driver in winning additional business. Moving over to update on Thermo Fisher. We recently met with Thermo Fisher representatives during ASHI conference in Montreal, and our strong collaboration continues in a constructive and positive way. Work is ongoing to understand what this means regarding volumes and sales generations over the next 12 to 18 months.
Worth emphasizing again, though, is that the collaboration with Thermo Fisher is developing in a positive way, and we expect the volumes to be back to normal levels during 2027. Now, a few words regarding our new products for heart and lung. Essentially, Devyser's expansion of scope to now include heart and lung from kidney only transforms our One Lambda Devyser Accept cfDNA product from being a kidney-focused product into a broader solid organ transplant monitoring platform. From a clinical perspective, this is important in several ways. It represents a non-invasive monitoring offering from a blood sample. Thus, it has the potential to reduce reliance on invasive biopsies, which is highly relevant, for example, in heart transplantations. Moreover, it is also worth noting that it includes pediatric patients as opposed to an adult patient population only. From a Devyser perspective, this is important too, as it expands Accept beyond kidney into heart and lung.
Put differently, it is the same core platform and workflow across multiple organs. Thus, it offers broader relevance for transplant centers and strategic partners to choose our solution and creates recurring testing potential across a larger base. On a more personal note, I would like to emphasize how impressed I am with the commitment demonstrated by Devyser's R&D team, as well as the regulatory team. The development of the heart and lung application has been very fast and effective, and with an encouraging outcome that will have a meaningful patient impact. As summarized in our last slide, the following is to be expected going forward. Underlying demand remains strong in our direct and other distributor markets. One-time inventory correction at our largest distributor, weak sales for the rest of 2026, then more normal levels during 2027. Our aim, profitable growth faster than the underlying market.
Focus on our core markets, the U.S. and Western Europe, with continued cost efficiency in the organization. Two partnerships, Thermo Fisher and Illumina, strengthen our market presence, and a new commercial leader is also in place. Milestones going forward, goal to announce a MolDx decision before year-end, FDA process progressing, and continued work on other IVDR certifications. Last but not least, continued focus on cash flow generation. With this, I would like to open up for questions.
We will now open up for questions. To ask a question, press star five on your telephone to enter the queue. When it's your turn to speak, press star six to unmute. The first question comes from Filip Wiberg at Pareto Securities. Please go ahead.
Hi, can you hear me now?
Now we can hear you, Filip.
Hi. Good morning. I've got a few questions today. I think I'll start on the Thermo Fisher and distributor sales. So you're writing that Q3 now had a negative impact from that largest customer, but just looking at it, so distributor sales were up now from Q2. You talked a little bit about other customers, like in APAC, for instance. So I was just wondering, did that largest customer order anything now in Q3, or otherwise, like what drove the strong performance in distributor sales?
The strong performance in distributor sales is coming from distributors we have within the hereditary product area, especially in Asia and Middle East, but also in Eastern Europe.
Okay. Was sales to the largest customer basically at zero this quarter?
Yes.
Okay, thanks. Just a question on the expansion now to lung and heart. As I understand, Thermo Fisher would have to buy new from you in order to be able to sell these new products. I was just wondering if you could give any sort of color around if you've gotten an order now in Q4, or if you believe one could come now in short?
Well, we don't comment on the specific orders in that case, but you're correct in the assumption that if a customer wants to test the heart and lung and then run that on clinical patients and in the real clinic, they need to order the new product. That is expected that Thermo Fisher will need to order those kits at that time. But I cannot comment on any specific orders for Q4.
Okay. On the outlook, you still expect a normalization next year. First, on the timing of this. Will we be able to see an effect already in Q1, or do you think that is too early? On that also, have you gotten additional indications from Thermo Fisher around this that makes you more confident in the normalization next year?
We have had several discussions with Thermo Fisher to give us a good understanding on next year. When it comes to the normalization, we do believe that the normalization will start in the beginning of the year, but it is important to note that that first quarter in 2026 was a very strong quarter for the distributor sales. That is what we mean that it is going to be a buildup during the year. We do not have exact numbers for specific quarters.
Okay, thank you. Because you provided this outlook in the Q2 report, we did not have heart and lung. Is that included in that outlook for next year? Just what kind of potential would you say heart and lung has in relation to kidney, and how much growth it could add? Anything on that would be very helpful.
Absolutely. When it comes to heart and lung, it is just released, it will take some time for the customers to validate this and test it, of course, as it is a completely new product. It is only one week old. I do not expect the heart and lung to be used in real clinical data for normally, I would say it takes up to two quarters before we can see an effect on that. What was the other part of the question?
No, it was more around the outlook around the normalization next year, if you included heart and lung into that, or if it changed-
Well, no, when we communicated in Q2, we did not include heart and lung in that. The heart and lung is additional to what we talked about in second quarter.
Okay. Okay, very good. Just last question for me is around the gross margin. The quarterly variation is quite difficult to follow. Q3 is usually weaker. Why was it so much stronger now compared to earlier years, and how should we think about it going forward?
Yeah, no, essentially the Q2 inventory one-off did not repeat. As you will recall, we had a weak gross margin in Q2, and we are now seeing the improvement primarily driven by our cost-saving measures having an impact. Added to that also the sort of the net pricing tactics and strategies that we are implementing. So Q3 was clean out of the one-off incident from Q2, but with that said, of course, sales and profit can and will fluctuate by quarters going ahead as well. But at the end of the day, this is very much a priority area for us, and we are pushing hard to maintain high gross margins.
Okay. I interpret that as we should expect some quarterly variations in terms of the gross margin, and it might not stay above 80% every quarter going forward. Would you say that's correct?
I wouldn't necessarily. There will be quarterly variations, but we're pushing hard, and this is a priority area.
But rolling 12 months, we have the target to be above 80%, and that is the target that remains, and we believe that we should be able to continue to push our gross margin in a positive direction.
Okay. Okay. Thank you very much. That's all from me. I'll get back into the queue.
The next question comes from Arvid Necander at DNB Carnegie. Please go ahead.
Okay. Good morning. Thanks for taking my questions. Just following up on Thermo Fisher and how this is developing. You say that work is ongoing and that you've had sit-downs with them, but have you had your sort of initial budgeting discussions with them for 2027, and what can you share about the assumptions underpinning your internal budget? How much visibility do you have into Thermo Fisher's current inventory levels and customer demand, and can you give us any sort of phasing of the expected normalization? I understand that it's still developing here, but you must have sort of a base case, I guess, for how this will develop. I'll start there. Thanks.
Yes. We, of course, have had several discussions with Thermo Fisher on this topic. We don't have a firm picture of what the year will look like. When it comes to the inventory levels at Thermo Fisher, we don't have an exact number on that either. But we do know that they have had good success in selling our products to the end customer, and they see good development in that area. I'm sorry I can't give you any specific numbers or anything more than that, what we said before, that we believe that 2027 should be back to what we considered a normalized level that we had before this, so back to 2025.
Okay. Thank you. Then I guess sort of on financial targets, as of right now, you're still sticking to the 30% growth targets. Based on your internal budgeting and commercial pipeline, when do you think this will realistically become achievable again? Do you believe that this is achievable before MolDx reimbursement and the FDA approval of the test kits, or are these factors more or less prerequisites to move towards that level of growth rates?
I will say to reach those level of growth rates, it is required with the successful launch of MolDx as well as the later on with the FDA approval.
Okay. Yeah. Fair enough. Just the last one, sort of on housekeeping, I would say. There is sort of fairly significant and repeated restatements on historical sales figures across both sales channels and geographic regions over many quarters, and this makes sort of forecasting and tracking underlying trends somewhat challenging. Just to understand this better, what is driving these recurring readjustments?
Yeah, I am obviously fairly new, so I am not sure that there has been recurring readjustments, but I do know that there was an adjustment made in Q4 last year. So what we have been keen in doing this quarter is to use the current classification, as that will allow improved comparability. Yeah, that is essentially it.
Okay. Yeah, understood. I will jump back in the queue. Thank you.
The next question comes from Erik Karlsson at CapeView Capital. Please go ahead.
Hi, Erik Karlsson at CapeView Capital. Thanks for taking my questions. Maybe one question, as a new joining CFO, what are your initial reflections on what can be improved and what you will spend time on focusing on at Devyser? Then one question on CapEx as well. It looks like you are trending towards SEK 50 million CapEx this year. Is that a good assumption, and what should we also expect for next year? Thank you.
Thank you. Yes, in terms of what could be improved, I think, I mean, having been here now since the end of August, I am genuinely very, very impressed by what I am seeing. With that said, of course, there are always things to improve. I mean, we have good momentum. We are working very, very hard within the management team. It is a difficult question, to be honest. But I think things are very encouraging, and it has been a good start for me personally, and I am very impressed, essentially, with what I am seeing. But we are pushing hard to drive continuous improvements across, really.
Regarding your other question, Erik, on the CapEx for the rest of the year, we do not see any surprises in the CapEx for the rest of the year. We had a fairly flat development of CapEx now for a while, and we see that going forward as well, also into next year.
Super. Then maybe one question on the gross margin. You mentioned both cost savings and price increases. Can you just elaborate a little bit there on both those elements? I know this is lumpy by quarter, but if we look two years out from now, do you think the gross margin is likely to be higher than today?
Yeah, so first of all, starting with the last part of your question, we don't give forecasts looking ahead or going ahead. What I can say is that we do push very hard to maintain a good and strong gross margin. Regarding operational efficiencies, which is part of the work and the improvement behind, or behind the improvement that you've seen, it's essentially cost efficiencies that we've been driving in the organization. When it comes to pricing, in healthcare or in many sectors, there's differences between gross pricing and net pricing, and what we're doing and what we're mapping out, et cetera, is ways to implement and identify areas where net pricing can be optimized, and that has a direct impact also on the gross margin.
Do you think we should think about net pricing? I appreciate this mix effect, different tests and customers and so on. But like- for- like, I don't know, you have around 30 products or something like that net pricing, like- for- like, would be positive in the next couple of years?
I can jump in and answer that. I mean, that's of course our aim to work in that direction, and it's something that we are constantly looking at, as Niklas points out. So, I cannot give you any numbers or anything else than that is part of what we are working on, yes.
Super. Thank you.
The next question comes from Filip Wiberg at Pareto Securities. Please go ahead.
Are you on mute, Filip?
Filip Wiberg, it's your turn to ask a question. Please press star six to unmute.
Sorry. Can you hear me now?
Yes.
Yes.
Sorry, I had some trouble unmuting myself. I just got a couple of follow-ups. First, just on MolDx now. I was just wondering what stage is the application at right now? You write that your goal is to have a decision before year-end. I was just mostly curious around, is that dependent on how quickly you can submit, or is it more on the review time?
It's more on the review time.
Okay, good. Then another one, just in the U.S.. I think you mentioned on the call now that you had strong performance in the CLIA lab. If you can just expand some around what drove that, like in terms of products and why now in the quarter?
Well, when it comes to the CLIA lab, it is, as you know, Filip, we have some of our own products, but then a big part of our revenue in that comes from partners. In this case, the strong performance in the CLIA lab has more been on the partner side, partnership side.
Okay. Okay, good. Very clear. Then just my last follow-up was around the reagent rental agreements. You mentioned you had one in the quarter, but there hasn't been any additional ones since you announced that. I was just wondering more what the pipeline is like out of next year, what kind of contribution you're expecting this to have next year?
It's a good question, Filip. I didn't say that we didn't have any more sales in Q3. What we did was that we posted a press release on the first one, and we are not going to post press releases on the ones coming after that. But we have had more sales in this area already in the books today. But they mainly are not giving any sales effect in the third quarter, but mainly onwards after that, due to installation times and so on.
All right. Okay, yeah, that's clear. But next year, you're expecting this to ramp- up even more then, and perhaps even be visible in the growth?
Yes, that is correct.
Okay. Thank you very much. That was all from me.
As a reminder, to ask a question, press star five to enter the queue. We have no more questions at this time, so I will hand the word back to the speakers.
Okay. Then from Niklas and myself, thank you, everyone, for joining our call today.