Q-linea AB (publ)

Hello, everyone.

You have Stuart Gander here, CEO of Qlinia, and I'm joined by Krista Samuelsson, my CFO. Thank you for joining this Q4 report from Qlinia, our year-end report for 2025. Just a quick disclaimer up front on all forward-looking statements. We'll take that as read. So typical format for this presentation is we've had in the past. I'll spend some time here just giving you an update on the commercial progress for the company, some of the context and dynamics we see in the market. Then we'll share a little bit of how our customers are seeing that with their patient impact and some of the evidence that's coming out of usage in the real world, which we're very excited about. And then we'll start to look forward into 2026 before I'll hand over the reins to Krister, who will walk through the financials in our quarterly report. As ever, we'll wrap up the end with some Q&A. So with that, and for those who have very little time and just want the highlights, a few key messages to walk away from on this report. So first of all, 2025 did generate significant growth in the top line. So we're more than 4x greater than previous year. We're excited about that. And consumables revenue obviously also growing and even faster year on year, which is great to see. It's being driven by the installation of the installed base, which I'll get to shortly. We do see, and perhaps most importantly actually, that the commercial pipeline continues to expand and we are seeing it move and develop. I'll talk about that in more detail. And really the exciting thing for us as we look forward is we expect the U.S. to start converting at a faster rate post our FDA clearance for an expanded menu that we're expecting in the first half of 2026. So obviously the pipeline we're tracking on both sides of the Atlantic, the U.S. one being sizable, and we do see progression starting to unlock post that expanded menu. On the sort of more internal side of things, we've done a couple things during 2025 that are going to materially impact our progress during this year. Firstly, we have fully now internalized our production of our consumables. That is generating already a significant savings on a per unit cost of goods basis. We will continue to see cost of goods declining through this year as both more of our improvement initiatives kick in and also the scale effect realization of having our own control over production continues to drive benefit there. And then we did do a sizable restructuring at the back end of last year. The new organization formally went into place 1st of January. So Christopher will talk a little bit about that on how that's affected our OPEX costs, which we'll now see coming off from Q1 and going forward. So we expect a material reduction in monthly OPEX through 2026. So those are the high level messages. I'll just give, again, a little preamble for those who are new to Q-Linear and Rapid AST. So we consider ourselves a leader, if not the leader, in rapid antimicrobial susceptibility testing for primarily blood infection patients. Our flagship platform is the ASTAR instrument, which has a lot of very compelling benefits vis-a-vis other alternatives on the market. and also vis-a-vis standard of care. And we synthesize this down to a few key points here. We see ourselves as really the only fully automated random access platform available all around the world. We have less than two minutes of hands-on time. It's extremely easy to use in the lab, very effective workflow integrating to any lab. uh and the test is highly predictable it always comes within six hours um fully you'll start to finish all of these sample preparation steps are done on board this fully automated platform and so what we anticipate in the market and we are starting to see and this is what is driving our consumables growth and our instrument placements through this year as we expect to see is that the market is going to move from an established standard of care today which typically takes 36 up to 72 hours to get a blood infection patient a full AST result. And we will see that moving towards a much faster solution, which we call rapid AST. And this will follow the most critical patients first. Obviously, the blood infection patients are amongst those, but there are other groups, you know, cancer patients, for example, pediatric patients, high acuity patients and so on. And we already see interest and traction in those categories as well. So, obviously, the total potential here is greater than the complete sum of blood infection tests, but our focus right now is on those blood infections. So, that's driving the trend here, and it is, from my perspective, just a matter of time before rapid AST becomes the new standard of care and replaces the old systems. So we tried to synthesize obviously a lot of dynamics through the year into how we see it. And I hope this picture starts to give some life to what we're seeing in numbers. Through 2025, we tried to provide more and more visibility on how the pipeline was progressing. We've talked a lot about movement here, and I'll get to how many instruments we expected to place versus what went into the market. But obviously, the pipeline, as we've talked about before, is driven by a very long cycle time, which is normal for our industry. 12 to 15, up to 18 months is entirely normal to go from start to finish on placing a new instrument in the lab. obviously this is a new technology. So there's a lot of variability in that. In previous pictures, we've shown full pipeline, including a very extensive list of labs that we're already engaging with. We're trying to show here now is really the, let's say the end of the funnel, the real tangible side of the funnel now, where we'll focus through this year and giving more visibility. And it's really the evaluations that are contracted, planned, or already in progress. So those are, customers that are physically touching the instrument or saying they want it in their lab to physically touch it, and or they're already in contracting, which is the very last step. So they've already decided they want Astar And we're working through the TNCs, maybe some pricing, that type of thing. And you can see the graph here that has grown significantly through last year. And already from what we came off of in December last year, represented here by the 8083 we're showing, is enough instruments to meet our plan for this year. These are all decisions that we would expect to be made during 2026. We may not win all of those, obviously, but we have a very strong track record once we get to this stage. I think I've referenced before that I would expect to, at this stage of the game, be getting north of three quarters of those if we hold our current win rates. So that... long way long story short we can see already the the deals we need to make the 2026 plan work in addition to that we will of course add to this as we go forward and we do see already that there will be a shortening of some cycle times as characterized especially by italy which has already seen more and more customers coming directly to us skipping some of the earlier steps starting to skip the evaluation steps this is something we would expect to also see towards the back end of this year in the US as we get a critical mass there. So we go from those in the pipeline into contracted ASTAR units. This is our kind of headline number. And because that's a very tangible one, we define that as when we've received a PO. So we ship the instrument against that PO. Often we charge for the instrument or we start rental. charges or can start shipping, obviously, the kits and so on. So this is the real number that we want to track through it. Here, obviously, we were giving a projection, if you will, for the end of the year. We wanted to get 30 or north of that. Obviously, we talked a lot about the E-star tender of nine units in Italy, which we were disappointed by the adjudication of that process. That, to my understanding, remains a little bit open, but we've put very low visibility on those ones for now. Nonetheless, we did continue to grow our contracted units in Italy, which still achieved plan. I think we were short in two areas. We were a little bit under in placements in mainland Europe. I'll talk about that in a little bit. But the main thing holding us back versus our plan number was the US. And this I think we just need to recognize is down to our initial FDA cleared menu, which is the drugs and the bugs that the clinicians can use. on the platform was smaller than our European one. And that was down to some technicalities of the R&D requirements for the clinical trial. And we recognize that we had hoped that with our bridging strategy there, we would get more of the customers signed on and using the instrument. And we were also a little disappointed that many of them are just saying we want to go when you have the full menu. Now, the good news is we have already submitted that updated clinical trial to the FDA as of October last year. uh so we are now in the fda review process which is more or less defined process and timeline so we have good visibility that we should be getting that clearance if not at the end of q1 at least during the first half of q2 uh which is when we plan you know against a full um launch into the us market of our expanded menu um can't say too much detail about that now obviously as it is an fda review but we do anticipate from the early feedback and conversation we're having that we will have a very compelling menu, especially vis-a-vis other alternatives on the market. So we are having very, let's say, open discussions with customers about how they want to get started once we have that clearance. So we have a queue lined up, if you will, to run against once that comes through. So hence, we expect the back part of 2026 to really unlock for the US. Then the next step of the journey here is ASTARs and clinical use. There is a lag from when we get the PO and ship the instrument to when they are fully up and running and ready to go with a patient in the ward, a real live patient. They typically do obviously some installation and training activities. They need to link it to the LIS, the lab information system, so I can take some time. And then they may do a bit of a soft launch with some clinicians, some patients, and really pay close attention to that initially before they go with the full patient base. That's quite normal ramp up. We participate very closely in each step of the way. And typically that process is between three and six months. And we're seeing that now shorten again in mature places like Italy, where there's more established experience with Rapid AST and ASTAR. So we plan for something around that three-month gap from contracting to going into clinical use, and we'll continue to monitor that. And obviously then the next and key step for us in our business model is when those then turn into the pull through on the patient testing. We do have a mixed model. In many cases, the customers do pay us for the instrument upfront, but in currently the majority of cases, we place that instrument on a reagent rental contract or some form of rental agreement and then have a pricing baked into the consumables and here what you're seeing is that rolling 12-month increase in the test usage going up and obviously that momentum will carry already into 2025 on the back of the 14 systems that are already in clinical use and will start to turn on more and more systems So that's the dynamic. I think all of those are very strong curves. You're talking, you know, 300, 400% increases, obviously, year on year. And we would expect those trends to more or less carry through into 2026. So that gets to a little bit of our outlook for this year and our run to breakeven. We have continuously held that 2027 is our breakeven year. That's in our long-term business plan. We're constantly calibrating on our assumptions on pull-through, on pricing, on gross margins, et cetera. And obviously, you know, it bounces around a little bit here and there, but the nice thing is we get more and more visibility and that range of possible scenarios, let's say, is tightening up. right so um you know we don't don't um hide the fact we'd hope to emerge from 2025 with more instruments again with that caveat that there's a lot queued up in the us for the v2 we do see that you know if when those convert in 2026 you know we will um achieve this this number here of an additional 50 um to 70 instruments during this year that we want to contract get up and running. I think previously we said 60 to 90. So there's some overlap in that range. And just acknowledging that, again, the Q1 here in the US is likely to be a little lower as we wait for that V2. And then carrying into 2027, more or less, that momentum off the back of this year, maintaining that Q4 pace through 2027. And then there's a range if that even accelerates from there. So that carries us past the break-even point that we're really paying very close attention to. So what is it that gives us some confidence that we're on track here? A number of things, really. Italy, we keep pointing at as our reference country. There's a few reasons why Italy is at the forefront. I think the Italians in general are enthusiastic adopters of new technology. and in healthcare space so this is not totally unusual but also they have a very high burden of antimicrobial resistance and the consequent impact on patients and budgets for the hospital and the country itself has been very progressive in defining guidelines and suggesting that hospitals and labs adopt the technology and we're seeing that not only in the placed instruments so far with Q-Linear and with some of our competitors, but also in the outlook for the number of labs that we're already having various degrees of conversation with. And we would expect that many, if not most of these, we're talking several dozen, will convert over the next 12 to maybe up to 24 months, right? So we would see Italy continuing to progress at a steady pace as it's done now. I've talked already about the US acceleration from Q2 driven by the approval of the menu. I think the other dynamic here that's a little bit special to the US that's very powerful is often when we do a contract, we do it with an integrated delivery network, which can be a cluster of five, 10, even up to 40 or 50 hospitals. And often they'll place one instrument in maybe the main lab or the central lab to get a feel for it. And then they'll plan a rollout because the IDNs really like to standardize their care for all the patients that they serve, obviously. They want differentiated outcomes for patients, depending on which hospital you happen to go to. So these planned rollouts we already worked through with the customer. We have visibility on some of these. Obviously, the timing can vary as the customer wants to manage the training and maybe some of the cost management and so on around a capital planning. But those impacts will start to show up even this year and definitely into 2027. We have a couple of markets that we also expect to move with more pace. Our partner Amico in the Greater Gulf region here has very close connections across the countries in that region. We have a number of evaluations that have already completed very successfully. We do expect those to now move into the contracting and deployment process. And I think the very exciting thing is there's a number of the Ministry of Health for those countries that are reviewing it along with other systems. And they will make some recommendations, guidelines, if you will, on adoption of rapid ST and or, you know, improving certain systems. So we're very excited about those conversations. We think that market will have some very positive dynamics for us. We recognize that Europe is going to continue to be slow but steady. We cannot ignore Europe. We also, I think, have a duty to the European patients to keep pushing this technology. We recognize that many of the European countries are really struggling with hospital budgets. And they tell us this, there is a gap in their actionability as they recognize between stated objectives for their sepsis patients, stated country guidelines in some cases, and what they're really practically able to do with their budget. So one of our focuses here will be on helping them understand the real cost savings that come from this, helping visualize that. There's some studies being planned with customers driving that work themselves to try to motivate putting this technology in place because we see this as net cost saving and driving patient outcomes. So that's Europe. We don't expect it to have a major inflection during 2026, but it will keep a kind of slow, steady background addition to our installed base. And then we are very excited about new geographies coming online. We did announce something already with Bangladesh. So we're excited to put that in play earlier this year and start treating patients in Southeast Asia. And then there are a number of countries that are queued up in various stages, if you will, of conversation and readiness to deploy Astar. The AMR burden is very high in some countries and it's not going away. So this is the underlying driver of our needs. Now for Qlinia, we're a small company. We need to balance our resources, balance our attentions. We're having a very customer-led approach here. So we engage closely when customers or very important key opinion leaders and countries are keen to go. And then we work with those flagship institutions or individuals on a plan for the overall country. And then the other thing we're excited about that we will expect to kick in during 2026 is expanding our reach to non-blood infections. Those are anything between two and three or four times the number of patients that are already in hospital. treatments for non-blood infections not all of them are critical there's a large number that aren't for example but again many of them are and especially high susceptibility patient groups like pediatrics and cancer that I mentioned so during the second half of this year we plan to launch a dedicated kit and kit software for non-blood infections that will have positive economics for the patients recognizing that their expectations here for non-blood are going to be different so that'll help us significantly we think it will be another let's say milestone for us in our leadership in this market to drive that as well so all those dynamics we see driving both the placements of instruments and the number of tests as we move through this year You know, we're not alone in ringing this bell. We continue to be present at all the major conferences, at least in Europe and the US. And in fact, I will be down with our head of EMEA, Franco, in Dubai next week for WHX, which is a large regional and global conference. conference uh to to continue to to reach out to the to the world uh for for culinary astar and the broader rapid st message um i think you we we're very proud to to state that we are making an outsized um uh level of noise in the market vis-a-vis the size of our company The collaboration partners that we have are top KOLs in their countries, many of whom are driving their own papers and presentations. They're working with our team. Here on this slide, you see Vikas making a presentation at ID Week in Q4 in Atlanta, and Natalie here was also with Vikas. in Las Vegas this month in Amari, which is a very exciting place. It's sort of a much more intimate setting with really the types of KOLs and stakeholders that we're looking to reach to. And the themes are very consistent. We are presenting the outcomes from from Astar we're presenting customer data we're bringing new perspectives on how to use our technology our our platform and that's being very positively received because in particular is expertise in cancer care overlap with AMR and continues to to drive discussions at high level with kols in that regard and and we see this as a really key patient group to focus on going forward. And in general, also across our industry and our stakeholders, they continue to raise this topic consistently. There's a very high interest in rapid AST, many of whom are putting forward the need in their institutions to reduce the time to actionable results from the diagnostic lab so that they can get patients on appropriate therapy. And there are also in parallel, more therapies coming from the pharmaceutical companies. And as they launch those often, greater cost than the standard treatments, there will be more and more need for diagnostic tools that help to tell them when they should be using these new drugs. So there's a lot of trends, let's say, in the background that are driving the interest in rapid AST. And I won't get to the details of this, not least of which I'm far from qualified as Dr. Rebecca Yee and Dr. and Vikas are to speak to the details of the science here, but this is an example of what's being presented from our customers on using Astar in their environment. And we keep seeing the same things over and over, but we have to keep stating it over and over until it's accepted that Astar is much, much faster than standard of care. And that that answer that comes faster is changing therapy in a high share of the patients. And in this particular case in George Washington University, when they look at the chart review, theoretical chart view, they would have made a change in 74% of the patients. In many cases, you're actually deescalating the patient, which means you're giving them a more narrow antibiotic that has less side effects for the patient and significantly lowers the cost to the hospital as well. and or you could be sending them, moving them from an IV antibiotic into an oral antibiotic, which is much easier to administer. And often then you can either discharge the patient or move them into a lower cost ward of the hospital or different treatment environment. Again, significantly reducing costs. And it's great to see the customers putting numbers against these. This is the types of things we will see from our lifetime paper that we continue to work with our collaboration partners in Italy. And other places like the UK are looking to do this on a more individual groups of hospitals, trying to put these things together to really show that this has material impact for patients and for the budgets. And it was really, I think personally, I was surprised to see how great the effect was here. estimate that they could reduce their drug spending by more than 50% across the entire patient population by getting much more quickly. As we like to say internally here, getting the third bag right, which is the third time you hang an IV bag, it needs to be the right one. And only Rapid AST and especially ASTAR can guarantee that. And often, you know, for a patient, you're going to be on six, eight, you know, 12 bags or so. So the more bags you save, the more money you save and less outcomes. So great to see that point continue to be made by our customers. So what do we see going forward? You know, focus for this year, this slide hopefully is visually familiar from before. We're not changing this on a too fast basis. Our focus remains the same, but we put more and more, let's say, clarity against it. So really continue to emphasize the commercial activity here. For me, you know, just simplifying it to an ASTAR week. You know, we need to hit that number, exceed that number, and we're more than good for making our plan here. There is a sizable queue of former Accelerate Fino platform users who've been left since Accelerate exited the market and is discontinued support for Fino. So we're working across markets to engage those customers, many of whom are reaching out to us and trying to put in place a solution quickly so they do not have to lower the standard of care again for their patients. So we're excited about that pipeline that's driving a lot of activity in the near term here. And then again, the first installations going into Asia and hopefully also Latin America soon as well. And then once we place the box, not losing sight of the fact we need to keep engaging with customers and driving up the test per ASTAR. on a going basis. I mentioned earlier some of the dynamics there. We also know that in some markets, again, budget-constrained labs are prioritizing these for their most critical patients, right? Using it as the escalation or for patients they think the current empiric treatment might not work, they might die. That's entirely appropriate. It's a very positive effect to using ASTAR. It's what motivates a lot of us here at Q-Linear. However, also using it for the broader base of patients, as we just saw from the previous slide, the 74% of patients that can be changed in therapy, many of those are going the other direction and saving costs. So as we engage with customers more of that data, they take the bet, if you will, that using this slightly more expensive test will actually net save cost. That's what they're looking for. We provide that data and we will see continued increases in the per instrument use going forward. And then, as I said, launching the non-blood testing as well at the back end of this year. So that will drive volume. Our clinical side and our R&D team are very focused, obviously, on the US version two menu, engaging with the FDA, making sure they have everything they need to make a fully informed decision, which we do expect in the first half of this year, as I said, and then developing that and launching that non-blood testing kit. And then on the financial side, which will be a bridge here into Krister, our priorities really remain the same, really focusing on the continued cost discipline. We've been trending down very nicely. I mentioned with the restructuring coming off the back of December last year, we're now in a much different cost position, which Krister will talk to. So we're committing to keeping that at or below the 11.5 as we go into Q1 here and through 2026 and then maintaining the other thing we're focusing on really maintaining a strong capital recovery as much as possible just because we're a small company and need the financing if you will from this so trying to encourage the customers to pay in advance for the instrument and of course they get a see that benefit in a lower test price. And in fact, many of the institutions that are larger, especially in the US, this is a normal way of doing things. So as we see this normalizing or there's IDN expansions happening, for example, they've already done one, they've tested it and they want to go forward. We do think this will start to tilt towards much more capital sales, which will provide us a tailwind on our uh on our cash availability uh and then you know we've already locked in some of the gross margin expansion that we expect continuing to focus on delivering that making sure the scale gains are real and achieved uh and then you know the rest takes care of itself if you will so on that note uh i'll turn it over to christa

Perfect. Thank you, Stuart. Stuart has covered the top line, the revenue part. I will go back and cover part of that as well. But I will primarily focus on the supply side in terms of personnel costs and other costs and the financing. But starting with the revenues, I'll continue where Stuart left off a little bit here. We are happy to see the big growth in revenues and we can see that it's based on the growing installed base, which is good. Obviously, we would like it to be even higher, as Stuart mentioned, but we can see the movement in our sales cycle pipeline and it's there and it will come. So we are looking forward to that growth and to see that in top line numbers. And as you see, the net sales last year was 11.1 which is almost 400 higher uh growth from from from 2024. now uh focusing a little bit more on the opex side uh we are very focused uh on the opex and being efficient we've been there for for a long time now and i think we deliver and it shows in the numbers we deliver and we will continue to be focused and continue to deliver lower opex numbers going into 2026. There is a typo in this presentation. The 11.7 you see there for the last quarter in 2025 on the average cost per month should be 12.5. It will obviously be updated in the report we log on our homepage. But even so, that is what we have guided before. And it's, as you see, we are looking forward to see OPEX go into 2026 below the 11.5 Stuart mentioned. And that's primarily based on the efficiency program we have just launched and concluded. But we are, as I say, we are always focused on being efficient and bringing down the OPEX, because that will actually bring the efficiency when we reach even closer to where we are now. And I would like to mention in the OPEX number of the 12.5, we have deducted the 6 million extra cost, the cost reserved for the restructuring, the cost efficiency program. These are actually primarily for personnel that have left the company, but we have taken the cost for next 2026 cost already in 2025. So you have to deduct the 6 million to get to the 12.5 as I mentioned. Looking into the financing, we've done two races last year. The second race we concluded in November. It was a successful race, rights issue. We raised gross 330 million kroner before the transaction cost and net 297 million. and we added a total of 12.5 million new shares and we are up to 18.9 million shares in total. We ended up with the liquidity end of December at 258, which was in line with what we internally projected. We had the 257 as an internal projection. So I think we have a good control of our expenses and our cash flow, and we will continue to have so. And we can state that we have going concern, which means that we have 12 months covered at least, and we are heading for the break even in 2027, as Stuart mentioned. And going into some more details on the OPEX, just to see the curve where we started. If you look at the curve starting in Q1 2023, up at the 20 million per month. We are now down at the 12.5 as I see, and we are heading for the 11.5 or below in 2026. uh and we will we will do it this we have delivered in the past what we have said when we've done the restructuring programs which now was the third since i came and we have delivered and will continue to deliver and we will see the uh the the revenue growth i'm i'm pretty certain about that one so with that i think we can take some questions i think we have some in in the feed super why don't you

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We might take some questions from the activity feed here and I just read them and some have been covered in the presentation by Stuart and myself, but I'll read them anyhow. First one is from Gustav at Red Eye. You have previously stated your expectations about the number of signed contracts during 2026 and 2027. However, this was not mentioned in the report. Can you clarify what the targets are?

and i you yeah okay sure um i think we we had a slide there uh where i tried to to lay out what will we look forward to in in both 2026 and 2027 and those are updated with the recognition that we are coming off the year now with 19th December, and then we've just announced another one in the US. So what we do expect in 2026 is that we would have in total between 70 and 90 contracted units. That's including the 19 we had at the very end of 25, and that we would get to 150 to 190 in 2027.

Yeah, right. And a good question from Gustav again here at Red Eye was what was the average utilization rate per system during the fourth quarter that is pulled through per instrument and months or instrument a year? We measure that one. And there is, as we have said before, it's a big difference now between the US market and, for instance, the Italian market. On average, it varies between the months, obviously. I mean, given the fact we have 12, 14 online instruments, so it can go up and down. So measure it by month and quarter. Can someone sometimes be a bit tricky to get the exact number? I would say we are at least the 500 mark. per year and instrument right now. That's where we are. And then there are some below and some above. I'm not sure if you want to expand on that one.

No, I think that's good. We obviously expect the U.S. to be on the higher end, right? And we'll continue to pull the average up as the U.S. sites come online.

Yeah, and that is the short explanation why it's not higher than the 500 is because U.S. is lagging, as we have said previously.

And I think the dynamics within the lab as they start using it and come up to speed on which patients they want to use it for.

Another question. What are the key challenges, risks that you currently see on the market?

It's a good question. The overriding challenge we have that we need to break through is just the natural inertia of the healthcare system. It's a very big space and we're one player among many trying to improve patient outcomes and get this to the top of priorities for labs to do. the challenge is not that people do not understand the value per se of rapid AST or that ASTAR itself is the way to go. In fact, I think that part is by far the easiest discussion to have. It's helping the labs, helping the clinicians get this to be the one thing they're going to do this quarter or next quarter or the quarter after, rather than something they wait to next year to do. So that's what's setting the pace for this entire market. And the more traction there is, the more reference customers there is, the faster and faster we think that will snowball.

A really good question here again. How long does it take from a contract signing until the unit is in full use? A key question, a good question.

Very good question. And one that is shortening. So I did say that we plan for around three months at least for that to take. It can be as little as a month or two if they're ready to go. But I think that's a fair number. Anything longer than six months we think is too long. So there can be reasons for that. often to do with the LIS technical integration, which is something the lab in the hospital often doesn't have control over. So those are IT resources and things like that. So when it's taking longer, it's almost always down to the LIS integration. But I think three or four months is a fair assumption for us as we think about 2026.

I think that sums up the questions in the activity feed. Let me see if I have anything else here.

I think that's about it.

No questions online, I guess.

Okay. Well, if no further questions, then thank you very much for joining. I look forward to connecting again for our annual report. Thank you.