Welcome to the Q-linea Q1 report 2026. For the first part of the conference call, the participants will be in listen-only mode. During the questions- and- answers session, participants are able to ask questions by dialing pound key five on their telephone keypad. I will hand the conference over to CEO Stuart Gander and CFO Christer Samuelsson. Please go ahead.
Hello, welcome everyone to our presentation of our Q1 report. Know that we're going into a long weekend here in Sweden, really appreciate everyone taking the time to join. I'll start off with the usual disclaimer here. We'll take this as read and understood. We'll go through the fairly regular agenda we've done on these. I'll give you some of the commercial updates here. I'll speak to our recent FDA clearance and what that means for us in the market and for our customers. Then I'll spend a little bit of time on our priorities for the remainder of the year before handing over to Christer to go through the financials and obviously the Q&A at the end.
With that, and for those who don't have very much time with us today, some highlight messages I would want you to take away from this presentation. The first point is that Q1 of this year was thus far a record one for moving instruments into the market. We put seven instruments out there. I'll talk more to that. We also saw our highest demand yet for consumables. This is notwithstanding an approval that came during April for the FDA clearance. This is our big news for this month. It materially expands our value proposition for U.S. customers. I'll speak to that. We think this will make a very real difference in the market over the coming months and quarters.
With that, we do expect to see the U.S. kind of jump-start from approval here. I'll speak to the pipeline we're working with and the dynamics there. We have a little bit of an update on our R&D side. We expect to be able to launch our dedicated isolate kit during Q3 of this year under research use only registration. I'll speak to the background of this one and what the opportunity is, but we're very excited for that news coming to the market back half of this year. Finally, as Christer will speak to in more detail, we have been successful in executing on our restructuring and cost management activities, so we now see our OpEx dipping below SEK 11 million per month with a favorable trend line in that regard.
With that, for those new to these presentations and Q-linea, firstly, welcome. Secondly, just a quick overview of what we do. We are a medical diagnostics company with focus on the bloodstream infection and high antibiotic resistance challenge in the world. To resolve this, we provide a integrated solution that's built around a diagnostic instrument called the ASTar and its associated menu that I'll speak to in more detailed during this call actually. It has a few unique features amongst many, but a few that really stand out in terms of making it unique on the market. It is the main fully automated random access platform on the market, the only one available worldwide, including the U.S. and Europe.
It is a very easy-to-use system, limited hands-on time in the lab. This is much appreciated. I will speak more to the what we're hearing from the market there. It provides a test in a quick turnaround time vis-à-vis current standard of care, saving upwards of 30 hours to wait for the test. As you always know, when you run an ASTar test, it will be ready in six hours. That's what we do, and what we're trying to achieve in aggregate here with our business plan and our objective is to really deliver for patients with acute infections, which start off with blood. Blood infection patients either have or at serious risk of acquiring sepsis.
Right now, these are treated by standard of care that will deliver an answer typically 36-72 hours after the blood culture goes positive. Our mission is to convert this to a same-day result, providing the answer in six hours from positivity. As I said, you know, we start with blood infection. There's, you know, 5 million-7 million of those in our addressable markets, but I will speak more on today's presentation to going beyond blood and what that means. I think what we're all interested to hear more about is how do we see the commercial pipeline progressing. I would start by just stating that obviously the U.S. market really gets going now with our V2 menu approval.
Our pipeline of evaluations and customers awaiting this has been building up in the background. You see that kind of in the increasing number of evaluations shown in the graph here, as the U.S. activity starts to pick up pace in expectation of this. Now our focus is on converting that pipeline in the U.S. Meanwhile, the rest of the world has continued, I would say steadily. Italy remains the leading market. We have shipped during this month a few more or signed a few more contracts, and we did ship some instruments during Q1 as well for contracts that were signed before the new year. Three new contracts have recently been signed, Italy is on pace.
We also have signed our first contract in the DACH region in Austria. We're excited about that, and we see positive outlook for the rest of this year and certainly going into next year as that region comes on stream for Rapid AST. We are excited about our first close in southeastern, the United States, on the back of V1, so that's already in place. The team there is trained. It's going live right now basically, with real patients. We will see the effect of that through Q2 and going forward this year. Obviously, as I said, you know, it's about for the remainder of this year really pushing on the conversions for the rest of the U.S. customers that have been waiting this approval.
In the background, once we, you know, sign the contract, and there's effort made to work with the site to receive the shipment and do the installation and training. That typically takes, you know, between, you know, one at the fastest, two or three months. There's a bit of a lag, and you see the ASTars in use, sort of ticking up in the background. That would be expected to track closely to the contracted ASTars over time. Then, from that, once we go into clinical use, we see the pull-through in the tests and, you know, the trend line is visible there as well.
I think the macro story here is that the European market is continuing on the plan that we outlined beginning of the year, and the U.S. market is sort of now off to the races with the approval that has been received more or less right when expected. In fact, the FDA was a few days faster for us than anticipated. I'll speak a little bit more to that in detail. This gets a little bit into the weeds of sort of what we do, I'll give a little bit of orientation. What you're seeing on this slide is a graphic that's essentially the menu that a physician is getting results for.
Each of the dots here represents a drug-bug combination that the physician is interested in seeing results so they know how to treat the patient. The more dots, simply speaking, the more options for the physician. What we did with this recent clearance was we increased the number of dots on our menu here by 93. We now have 215 approved combinations in the U.S. This is by far the market leader. I'll speak to that in more detail in the next slide. From a physician perspective, also what's critically important is we've added a number of new drugs that they were really waiting for, specifically ceftriaxone and ertapenem.
If we had to pick on a couple things, these were the two big ones that were holding back our V1 menu, as they are go-to drugs for physicians as they consider their therapy decisions, and they wanted to have these available before recommending ASTar for the breadth of their patient population. Another key feature that's very relevant for physicians and obviously the labs is that now with this approval, we also have the update to all of the latest FDA breakpoints. I won't go into the details of what that is. Suffice to say that, you know, over time, resistance changes in bugs, and that affects the breakpoints. You wanna make sure that you're getting an instrument that has the latest and greatest view on those that the FDA regularly updates.
Now we have that all embedded and approved on the platform as well. This is a huge step forward for us clinically in terms of a value proposition. Like I said, for customers, we now have the broadest antibiotic and pathogen menu available. We no longer see any major clinical gaps for a physician. Like I said, ceftriaxone, ertapenem are now there. That gives them more options for therapy decisions. That increases the value of the platform. It also gives crucially more confidence now to deescalate to oral therapy. That's where a hospital would see savings when you have patients that are waiting for one reason or another in an ICU bed that's very expensive.
They are holding them or can't discharge them until they have confirmation of the resistance profile of the medications they would like to send them out on. Now we have more options than any other on the market to provide that. What we see now going forward for us is that the pipeline we've been diligently building here in the background will start to convert. You know, I think I've mentioned it before, we had hopes that the Version 1 menu would be able to carry us there, especially with the efforts we did on our bridging strategy. You know, we understood some of the clinical limitations. Now that those limitations are gone, there's really sort of no excuses for not deploying. We do expect to see a difference here going forward.
I'll get to this in a second, you know, we're very confident this makes us the clearly differentiated gold standard platform in the market, both with the clinical side of things with the menu, but also just, you know, reinforcing the underlying proposition for ASTar in terms of ease of use and its very efficient workflow for the lab. This is another picture of basically that same menu, but color-coded here. We just wanted to use this as a visualization for, again, as if you're a physician or a microbiologist in the lab, you have different tools you can choose from, and this menu of results is a key factor in selecting those tools.
What we've done here is we've taken the liberty of overlaying the ASTar menu on top of what would be the next best system you could buy in the market in the U.S. Anything orange on this picture here is Q-linea or ASTar only. Anything blue, it would be something that we do not have on our, on our platform. I'll talk a little bit more on that in a second. Just right there, you can see that there's a lot of orange, this makes it a clearly standout differentiator. For clarity, all the gray boxes that are shown here are available on both platforms being assessed here. You know, I'll call out a couple things. First of all, you'll see some stars on the combinations.
Not all drug-bug combinations are created equal. You know, for each type of pathogen, you have typically recommended therapies for either empiric treatment or escalation or de-escalation. Part of the trick here is to map our offering to how hospitals really use the drugs in their clinical setting. We've done a lot of work to understand that and how that differentiates or differs between markets. The U.S. is different than Europe in terms of how it applies it and similarly for the, for the world, as a whole. And we have now a very strong U.S. specific offering.
The stars here, you know, indicate many of those combinations that, you know, we have that, you know, are certainly not available on the second best and in most cases are not available on any platform on the market other than ASTar. So we think this creates a very standout, you know, offering just on the surface. You click on that and it, you know, gets even better, so to speak. The ASTar platform, the way it was built with the disc with 336 wells allows us to provide a lot more dilution steps per drug.
The reason why that's important, basically a dilution step is a data point for the physician, and it allows you to provide the, we call it the MIC value, but the specific result, at that dilution step. If you do not have as many steps, you're forced to make some compromises. Either you skip some and your system is interpolating or extrapolating the findings which isn't a true MIC, and this is never the case for an ASTar. You are always getting a true MIC.
In the worst cases for other platforms that don't have the number of dilution steps, when the break points change, it means they can drift out of the dilution range that you have available and that, you know, really changes or decreases the value, clinical value of the results. You know, just reinforcing again our advantage that as the FDA break points were updated in this latest round, we were readily able to update the system with all of those because we always have all of the dilution steps. You know, this is, you know, as I keep saying, a huge step forward for us. It makes us clearly very, you know, very clearly the leader here.
Those with observant eyes will notice there's a couple blue lines where there are drugs we don't have. One of them, imipenem, has been by and large replaced by other carbapenems here on our menu. We're not at all worried about that. There's no stars there. That doesn't come up in physician conversations. The other amoxiclav we actually have on our disc. We have the European formulation. We're working to add the U.S. formulation. There of course will be some labs that would maybe look to our results using our advanced user software just to validate other forms of testing on the amoxiclav. You know, there is still some value from what we have there. We're not worried that this is in any way a showstopper in that regard.
There's plenty of alternate information available on our platform for any physician. You know, we obviously can make a lot of claims ourselves, but we are particularly excited when the customers, you know, make statements and for their own right. We were particularly proud and happy for the team at Baylor Scott & White when they were recognized by Microbiology Spectrum, a leading journal in the microbiology space for their pioneering work in RapidAST. The team has been an early adopter with us. We've worked very closely, and it's been fantastic to see them putting the ASTar into clinical use.
Now we've had some time in hand, so to speak, with the instrument and we're starting to see the data coming out from that, and they were able to put this into a journal that was accepted. A big congratulations to that team. I would say the results are not overly surprising for those who have been following us before. They are confirmatory to what we've seen before. Obviously, the performance of the ASTar is very high, and always nice to see that on true clinical isolates. They differentiate that in the study between real life patients and those that are, you know, pulled from, call it data banks or bio banks. The real life, in-clinic performance, very high for ASTar.
We see the same results over and over and over every time we do these. Significantly faster test result than standard of care. Here we saw, you know, in excess again of 30 hours of saving, and this can be life-changing for a patient. Obviously has very positive economic benefits to the hospital as well. I think very interesting to see data, and there was more breakdown for those who have a chance to read it in terms of the therapy recommendations that would have been made on the ASTar results, would have influenced around here 83% of cases which is I would say higher than sometimes we see. Sometimes we see, you know, 75% or so.
Here, obviously these patients benefiting from the more accurate results that ASTar can provide faster. In roughly two-thirds of the cases they would have been able to deescalate the patient off of broad spectrum or aggressive treatment onto something that would have less toxological damage for the patient and obviously reducing the exposure and long-term resistance impact from overusing our last resort drugs or you could say our aggressive drugs. In very importantly in 14% of the cases, patient would have been escalated. This is very meaningful 'cause that means the empiric therapy they were receiving would not likely have yielded as good results clinically, so possibly life-saving, right?
In addition to all of that impact on the, on the patient, which we're very pleased to see, the report also highlights many of the downstream benefits that we would expect to see from adopting Rapid AST. Obviously the side effects I mentioned reducing overall antibiotics exposure, being able to discharge the patient more earlier, as I talked about before, and overall reducing the length of stay. Again, these are really tangible in-clinic, in-hospital benefits that are seen when ASTar is adopted. Very happy to see that Baylor Scott & White is finding that and Microbiology Spectrum was open to putting that into publication. On that note, you know, we've not stayed still in terms of the value proposition.
We've, you know, from the outset have been aiming to provide a comprehensive solution for improving treatment of patients with infectious disease. As part of that, obviously, the blood infection patients were the number one place to start, the most critically urgent, call it high-value patient, if you will, but not losing sight of the fact that there are many other patients in the hospital that could benefit from a faster result. We have long had an idea to develop a non-blood kit, and now we're very proud to say that we have visibility now on launching this under research use only application during Q3 of 2026. In advance of that, a couple customer posters. We highlight Baylor Scott & White again as an active user.
We were very happy that they were open to exploring the research application here with us, with very positive results, and excited also that an Italian customer, active customer of ASTar also saw, you know, similar results as well, both pointing to the fact that ASTar is as reliable. You see, you know, very high performance in clinic when you apply isolate tests. We did our own, you know, very, call it, aggressive testing with some of the most gnarly resistance bugs we could get our hands on, and our poster that was also presented just highlights that the performance stays high with ASTar. It is a very robust system.
I think the other thing to highlight that the Baylor Scott & White paper points out is that the workflow for ASTar is extremely easy in doing this. Because everything is done on system for the blood test, it basically doesn't change, so you can go essentially straight from the plate in the lab where you're culturing the isolate straight into ASTar with no intermediate steps. And this can sometimes be a barrier for hospitals in doing a rapid test off of this because the workflow challenges for other platforms. It just, again, it further doubles down on ASTar's ease of use that was designed really for this type of application in mind downstream. We're excited to see this obviously for the research customers initially here.
Timing of a full clinical product will be a little bit contingent on feedback from the market, but we should see some effects from this already from the RUO launch hopefully during this year and through early next year. Before I close out, just a kind of recap of our short-term priorities. We remain ultra focused obviously on that commercial pipeline. The drive, as I keep saying, on those U.S. customers, they've been standing there waiting enthusiastically in line, you can bet the team is on calls with them all the time now, planning timelines. You know, just to set expectations, obviously, you know, there's lots of steps. There are, you know, we need to go through contracting, legal in many cases, and so on. These are large institutions.
This will not happen overnight, but we will be working on the backlog and getting instruments out as soon as we can. Some of the other things we're doing, we do see that, I mean, Italian footprint continues to expand at a pretty predictable pace here, converting the pipeline we see in Italy. What we're really working on now is to take the positive feedback that we get from the physicians and the lab and to turn that into more tests. The Italians are very open that due to economic reasons, basically budget constraints, they have to ration which patients get RapidAST. And they know that's not an ideal situation, but it's when you're adopting a new technology, it's often the case.
What we're doing now is to work with them to highlight the impact that they are seeing in their clinics and to help manage their stakeholders to increase testing over time. This will not be something that is a major step change overnight, but we already see positive trend basically month-on-month. We get more and more advocates, let's say, in our corner. I will continue to point to Italy as the bellwether for what to expect from RapidAST. They remain in the lead here. Very good to see that trend. We will continue to work on that. Now, the team with Franco is working diligently on expanding our footprint. On previous calls, I've said we've been, you know, wanted to remain very focused, conscious of resources.
Now is a good time. You know, we got through the U.S. launch here now, we can focus on the next step, which is adding the next tranche of geographies to our distribution set. I would point out that the ESCMID conference that was held here in April in Munich was very energizing. I had a chance to talk to, you know, dozens, in total, we spoke with, you know, 100+ customers, distributors, and so on. I interacted with many of the distributors there. Very encouraging to see that not only is RapidAST seen as a solution for critical AMR challenges around the world, we knew that, now ASTar really standing out as the platform that distributors want to work with and to bring it in.
They're coming to us with specific customer deals or lead flagship customers in their markets that they want us introduce ASTar to and start working on. This is the work that we have been working a little in the background, and now we really double down and get that going. On the clinical side, you know, belabor that, I talked about the non-blood testing, the isolate testing kit, work pivots to getting that on market now. As well as the next phase, which is to add more drugs. The fortunately for patients around the world, pharmaceutical companies are not standing still. They know resistance is increasing on existing therapies. We need the next line of defense against infection. We will keep pace with them.
I would say one key advantage here now is being seen as the gold standard in this field is that the pharma companies are very open to working with us actively. Several of them have already provided us with active ingredient to work with guidance on how to support our formulation and crucially with help with characterizing bacterial strains so that our algorithm work goes even faster. It reduces cost and time for us to get new things on the market and has a positive effect for them when the leading diagnostic instrument can give a readout on the relevance of their new therapy vis-a-vis existing therapies. A powerful, let's say mutual benefit for all parties, including the patient.
The not losing sight of our continued cost-down activities, we do that also for OpEx. Christer will speak more to that. The team is paying a lot of attention on our COGS as we see the scale growing in consumables. I've talked many times that we have a set of activities we will trigger at each volume milestone, we look to seeing those milestones and setting up to realize them so COGS continues to come down against plan. Now with the instrument shipments growing, like I said, seven in Q1, that, you know, the COGS in the instrument becomes more and more relevant, so activities happening there as well. I won't step too much on Christer's points on the financial side, I'll turn over to him.
Just suffice to say that we're very happy to see that we're on plan here, trending down below 11 as we guided to before. One of the things that I'm focused on here in the commercial side is that we maintain a, as good a capital recovery profile as we, as we can. Obviously, we know many customers will want to place the instrument on reagent rental. That's fine. It's part of the business model in our area. We expect it. We plan for it. It's a good model for us as well. That said, it does require more capital from us as the instrument is out, and it takes more time for the money to come in.
The balance of this is key, making sure that we're working with customers where they have the balance sheet to use that to mutual benefit, to allow our cash runway, you know, to go as long as possible. That's another big area of focus for myself and the commercial team and, obviously Christer as well. With that, Christer, I'll turn it over to you.
Thank you, Stuart. I will reiterate our financial priorities at the end of my presentation. Obviously, I will start off with the first quarter result, starting with the top line. As you might have seen, the net sales is lower than the previous period last year, the same period last year. That's due to the lower capital sales this quarter. We are glad to see a good improvement in the recurring income, that is the sales of consumables are up 60% approximately compared to same quarter last year. This is our key priority in terms of net sales.
Obviously, to increase the net sales for consumables, we need more ASTars out there, and we are very glad to see the FDA clearance of the V2 panel in the U.S. That will be very helpful going forward, and also in terms of having higher pull-through, that is number of tests per ASTar. It will help that we get some more ASTars placed in the U.S. Going, looking a little bit more on the OpEx side, as Stuart said, we had an outlook in the previous presentation where we said we will be around the SEK 11 million-SEK 11.5 million mark per month. We are now below that number. We are at SEK 10.7 million for the first quarter. We believe that's a sustainable level through 2026, and we are happy about that.
We are not so happy that we are not doing anything more. We will continue to focus a lot on OpEx and being more efficient, and we have a lot of initiatives ongoing, and hopefully, we can come down even further than this. So far, as planned or a little bit better than planned. Looking at the cash flow obviously follows right now the OpEx line more or less. Going forward, this will change. When business volume increase, depending on the mix of what we call capital sales or reagent rental contracts, we will require more cash in the business that is invested in ASTars in our business. We are looking forward to that, and we have plans for that I will get to a bit later.
So far, we are tracking as planned in terms of cash flow development. Looking a little bit more deeply into the OpEx development, just for some new participants who haven't been looking at Q-linea before, the past three years, we have come from like SEK 20 million OpEx per month, now at a little bit more than the SEK 10 million mark per month, which is a drastic decrease actually. It's 47% decrease comparing the Q1 2023 and Q1 2026. We will continue to focus on that, as I said, and one of the things we are in the midst of doing right now is the consolidation of facilities in Uppsala, where we will gather all personnel in one site.
It will lower expenses, yes. That is good. I think even more importantly, it will increase our efficiency when we sit at the same place. We are now like a little bit less than 70 people employed and 55 persons in Uppsala. It's helped a lot to actually sit together, talk, and solve all the issues in a much faster way. We are happy about that one. Looking on the number of employees, as you can see on the bottom right, we have got come down from the 149-ish to the 73 today. It's a drastic decrease over time. Going forward. Sorry, that was a quick one. Going forward, the EBIT improvement, if looking back, the EBIT improvement has come from the OpEx, lowering OpEx, which is good.
Obviously, there is a limit to that, and going forward, we will see the EBIT improvement coming from the sales and the gross profit, and we look forward to that. As I said, I will reiterate the priorities going forward. We are, as always, looking for increase in consumable sales. Yes, we now believe with an FDA clearance or the V2 panel in the U.S. we have a good chance of doing that since the U.S. customers in general are bigger and they will consume more per ASTar. That will help us a lot. Obviously we need is to sell and install new ASTars. That is the key and we have a great pipeline supporting that. It's about, as Stuart said, conversion.
Now, the OpEx level is a key, we will strive to keep it below the SEK 11 million mark per month. That is the top, not above that one, but obviously we will strive for even lower. The other, the third one is to secure the ASTar financing. Looking at these three priorities, we can control fully the OpEx level. That's in our control. If and when we will increase the number of ASTars placed and the consumable sales as we have in the plans, the secured ASTar financing, that will not be a big problem. Obviously it's linked to the success of the sales and the deliveries of ASTars. Once we get that going, we will secure the ASTar financing. What it is.
We have ongoing discussions with this, so, we feel pretty confident that that will happen once the business in the U.S. and elsewhere will increase as we anticipate. Basically that's all from me, Stuart, so back to you.
Super. We'll open it up for Q&A.
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.
Great. Christer, why don't you help us just highlight the questions as they come in?
Right. So far, no questions in the activity feed as I can see here.
Right.
Right. Now, there's a question from Anders Pettersson here. The question is, how has the collaboration with BlastID developed since 2025?
Yeah, good question. Well, I caught up with Paolo in Munich, and he was up visiting us here as recently as last week after the Munich conference. We continue to stay very close there. You know, both companies share a vision here that we have an opportunity for a direct from whole blood product. The proof of concept work that we've done demonstrates that this, you know, this can work. Basically the ASTar component of that, you could say is broadly speaking complete. BlastID has a fair bit of work on their side, which they're making progress on. I cannot speak to that in detail. To be honest, I don't have all the details. Paolo would do that much better. Other than say we're staying close, right?
As I said before, you know, there's various ways we can go with this together. At the end of the day, this comes down to timing for the market on when a direct from whole blood solution would be warranted. I continue to maintain that a direct from positive blood culture solution is what the market is looking for now. It provides very significant clinical improvement versus the standard of care, so it's already beneficial there. The main challenge with direct from blood is not necessarily the technical one, although that is material, but I would say the teams at Q-linea and BlastID are very technically savvy. I'm not worried about the technical challenges.
The challenges are often economic, because you have up to 90% of the cultures or the patients that draw blood suspected of possible infection are negative. That economic challenge is one of the major ones. We obviously have some ideas on how to get around that. But it also is a factor for timing in the market that informs some of our thinking here on how to go forward. It was a long answer, but hopefully fulsome in terms of, you know, we stay close. We're excited for their progress. They are working on some technical solutions there that are encouraging, and more to come.
Let's see. Thank you. Thank you, Anders, for putting this question. Thank you. See if there is anything else. A bit empty right now, Stuart.
People are keen to get to the long weekend maybe.
Yeah
It's understandable. I appreciate everyone who stayed on through the end. Thank you very, very much. I look forward again to connecting for those shareholders who want to attend our Annual General Meeting, you're most welcome. Otherwise, we'll catch up on the Q2 report review.
Thank you.
Thank you so much.