Q-linea AB (publ)

Welcome to the call. Happy Friday, and thank you for joining this presentation of Qlinia's Q1 report for 2024. You have Stuart Gander here, the CEO, speaking. I'm joined by my CFO, Christopher Samuelson, who will speak towards the end of the call. So, we'll split the time between some updates and comments from my side initially. Before I'll hand over the baton to Krista, who will speak to our financial update in more detail, and then we'll open up at the end for questions. So with that, I wanted to just start by highlighting a couple key messages that we would like everyone to take away from the session today. So first of all, we're extremely proud and happy to announce or have announced that we achieved FDA clearance for the Astar product as of April 26th. which is a huge breakthrough for us and opens up the U.S. market for full commercial activities. We've been present in the U.S. for some time now with pre-marketing activities. I'll speak to that more in detail in a few minutes. But until we have clearance, we were not able to have full commercial discussions on, for example, pricing and placing commercial evaluations. So we are now able to do those activities and we're seeing the interest growing in the market commensurately. Secondly, we have presented during the quarter some initial results from our ongoing clinical studies with our scientific partners in Europe. These results were presented at a couple of conferences, which I'll speak to in more detail, with strong reception. And those data coming from the clinical trials are showing very positive results in favor of rapid AST and the potential for improving patient outcomes. Thirdly, we have completed as of this month, essentially, the cost saving program that we announced earlier. This program is anticipated to generate 50 million crowns of annual saving versus our run rate coming off the back of last year. With the completion of the program, we can confirm that we will achieve this target. uh and and those should be fully visible in our p l from july onwards and then finally the main from the main messages perspective you will have seen the announcement that culinia has achieved additional financial um additional financial facility from next to be in the form of a loan facility uh krista will speak more to the terms of this towards the back end of the call But this gives us an additional total amount available of one hundred and one point five million, including some of the remaining facility that was available to us before that has been extended. So Crystal will speak more to those terms, but we're happy to announce that we now have the financial cash resources to continue our commercialization progress. So with that, I'll go into a few more detailed comments from my view on the quarter and a little bit of year to date. So overall, for me personally, it's been a fast and furious first 90 days in role as the CEO, having started in March. I did have a month of handover with Jonas Javius that I was very appreciative of to be able to get up to speed with everything. And I feel that the handover has gone very smoothly. And I'm still in regular contact with Jonas and he is still very supportive of any questions or needs that we have. But from an operational perspective, we're now up and running fully. I've had on my plate really four key priorities that I've been pursuing over the past months. So firstly, ensuring that we continue to accelerate our commercial activities and commercial traction in the market. On that note, we did ship our first commercial instrument into Italy. So that is up and running. We announced that tender win earlier and happy to announce that that has been set up and it's being used now clinically. So those patients in Tor Vergata are now receiving the benefits of Rapid AST, which is very fulfilling for us to see as a team that we're now having real clinical impact in the market. As I mentioned, we also had strong reception for our clinical results presented at the Italian conference AMCLI, where we were able to present to a very large audience there of attendees, and also at ECMID, where we shared some posters highlighting the findings from the interim findings from those studies. Finally, on the commercial side, our efforts have really been focused now on ramping up the U.S. pipeline following FDA approval. We have received very strong interest from a number of customers that are now preparing commercial evaluations, which we anticipate to be going in over the coming months. And also, in parallel, have continued our efforts across Europe working with our distributors We have a number of evaluations on the European side also planned that we expect will materialize into signed contracts and tender wins hopefully over the coming months. The secondary priority for me has been continuing our innovation in the field of Rapid AST and our product development. Obviously with the keystone here of our FDA approval for our version one menu in the US, we're very pleased, but we don't stop there. We will continue to evolve and expand our offering in Rapid AST. So we've already completed a pre-submission for a version two menu into the US that will give us more drug and bug combinations. And we continue our efforts in a focused manner on building out more capabilities that are inherent to the ASTAR platform, notably expansion of the menu into gram-positive bacteria. So our R&D efforts are focused and really oriented around expanding the value proposition from the ASTAR platform. My third area of priority over the past months has been around organizational readiness. Obviously, coming in the process of an organizational restructuring, there was a lot going on and wanted to make sure I was spending my time, ensuring that I understood how everything is working at Q-Linear and how best to optimize after the restructuring is complete. So with that done, I think we're now in very good shape to pursue our commercial growth agenda and to continue our R&D efforts. The reduction of staff that was implicit in the restructuring program has also enabled us to consolidate the team into a single office. Previously, we were in a couple locations in the Uppsala Science Park. So this, of course, has some additional benefits of savings on the facility cost side. But I would note that across the team, it's been commented that it's also allowed us to increase the energy and interaction as the team is now all co-located. So a nice positive from a company culture perspective. And then finally, we have arranged for our 3PL logistics in the US in anticipation of the clearance. And now we will be making commercial shipments of our products. So we wanted to ensure that we were set up in advance of that. And we have a good partner in the Raleigh-Durham area who will enable all of our in-market logistics going forward. So that's in place. And then my fourth area of focus has really been around securing and continuing the financial health of the business, obviously working with Christa and the board and the whole team, working through the cost savings plan to make sure we get everything that was expected from that, and also continuing to look for further ways to optimize our spending, ensuring that we keep the focus on the commercial activities. Overall, I'm very happy to say that we're ahead of the plan. And we're seeing those savings realized in the P&L, even a little bit ahead of plan. So for me, the focus really going forward is around achieving the top-line growth results, and I'll speak more to what we're doing there, while ensuring that we keep very conscientious use of our resources against our mission and our priority activities. And then I already commented on securing the financial loan from Next2B, which gives us now the runway to continue. So with those highlights, I'll go into a few more detailed comments on those points. So just on the FDA clearance, those of you who've looked online will have noted our panel that's been approved. You can see it here. We're very proud of this. largest panel available for gram-negative testing in the market, with 18 antibiotics and 12 microbial species. I would highlight that the ASTHAR platform has the unique capability of providing multiple dilutions for each of the antibiotics, which gives a more granular result for the lab manager and the consulting physician, and therefore a better ability to adjust the treatment for the patient. So that's a benefit that's just intrinsic to the way the Astar disk is designed. So this panel we're very happy with and allows us to get active in the market right away. We have a larger panel available in Europe, and we will continue to work with the FDA and our clinical data work in the background to ensure that we have an approval pathway for an expanded panel. So the value proposition that we're bringing into the market is really centered around the core features and benefits of the ASTAR platform. First of all, fast turnaround time for clinical results of six hours or less. This time versus the standard of care, which can take days, has an immediate benefit of saving lives in sepsis, but also saves money for the hospital as such this is one of the most and overall the most costly treatment in an in-hospital environment across markets and also a quick result means the lab can close the case and reduces the effort and time needed for lab management in following up and on that note the actual test platform itself has two minutes or less of hands-on time in the workflow which is extraordinary in a diagnostic environment Very simple instrument interface for a lab tech requires limited training, very intuitive usage, and it's a true load-and-go platform, which means there are just a couple steps to do. You place the cartridge and the disk in the instrument, and the lab tech can walk away, and the instrument already indicates exactly what time the results will be ready, so they can plan for that in their workflow. And then, as I mentioned, this is the most robust menu in the market is also the first fully automated random access platform available in the market with that comprehensive menu, very high reproducibility of results, and the ability to load 12 concurrent patients onto the platform is unique and provides a high throughput for the largest labs even in the U.S. So I'll speak more to that in a second in terms of our addressable customer base. The results of the US clinical data that were generated were very positive. I won't go into the details here, but you can see the data coming out of our clinical study against the requirements for FDA approval and ISO standards. So the results were extremely robust. We're very proud of that. The chart on the lower right-hand side we've shared before is just an illustration of the total menu potential for the AtStar disc on the gram-negative side versus some selected competitors. And you can see that the benefits of those drug-bug combinations in combination with the high number of dilution measurements for antibiotic gives us a much more granular result for the physician than anything else available on the market, which we think is a very compelling proposition for labs and physicians. So what are we focused on now? Our efforts are really tuned to bringing ASTAR into the U.S. markets. We've obviously started with some of the major players in the space. Prior to FDA approval, we've been engaging with some of the key opinion leaders and research leaders in the field in our early access program, which has meant that a number of facilities and their researchers are now intimately aware of the benefits and the relative superiority of Avastar vis-a-vis other alternatives. And this will help us in terms of accelerating our commercial efforts in the US market. And what we're really focused on is all the hospitals and labs of sort of a medium size and above. This is not a point of care solution for a small clinic. But that said, the facilities we're targeting address 90% of the total blood culture sets or the total number of patients for sepsis in the US market. As I said earlier, our platform is very well tuned to the needs of these extremely busy and physically constrained labs. limited amount of bench space and the ASTAR instrument has been elegantly designed to fit in well in the lab and have that very easy workflow. So we will be focused on building that pipeline, but we've already got interest from dozens of customers that are now working through timing essentially for getting those evaluation systems in so customers can try it in real time in their clinic and make the decision for purchasing based on that. So as I mentioned, we were present at ESCMID 2024 in Barcelona at the end of April. Timing could not have been better since our FDA approval actually came at the opening of the conference, which was yet another reason for folks to be interested and come on by the Q-Linear booth, which was very busy throughout the conference. I would note that it was very interesting to see the rapid AST was one of the overall themes for the conference. There were numerous scientific seminars hosted by researchers in the field and papers published independent of those that were presented from Chilinie's sponsored investigators. So it is clearly an area of high interest in microbiology. There is an acute awareness of the need for a better solution for sepsis for the patient population. and a growing awareness of the technical capabilities of these emerging technologies, which we see Astar as the leading proposition from a technical perspective. So we had a high amount of interest in our booth, both from customers right around the world. This conference is the largest one globally with almost 16,000 attendees. So it really was interesting to see the level of interest, but also the pre-awareness from customers in Asia, Middle East, the Americas, et cetera, who wanted to come by and hear more. So this gives us a lot of energy to continue to pursue our global growth ambition and is now translating after the discussions with a number of potential distribution partners is now translating into tangible conversations. We will planfully be expanding our global footprint over the coming months and quarters. As I mentioned, the clinical evidence base is growing, so both studies that have been sponsored by other third parties, but also those that we're closely involved with. We had the opportunity, as I mentioned, to present these to conference attendees, very well attended sessions with a lot of interest, but really the highlights here are the clinical results that we feel speak for themselves. So we have an ongoing Health Economics and Outcome Research study ongoing in Italy. It's a multi-site study that is generating some very robust data demonstrating that the impact of using rapid AST can shorten the amount of time for their patients from between 20 and 34 hours versus the current standard of care. In an environment of septic infection for a patient, that is a tremendous improvement. The ability to adjust therapy and give life-saving drugs in a timely fashion is critical for positive outcomes for patients with sepsis. What we also see from the study is that a significant share of those patients, 45% of them are receiving adjusted therapy. This is in line with previous studies that have indicated that up to half of patients are receiving suboptimal therapy. um and and this this study is is uh reinforcing that in a real life environment and then finally of those that are receiving adjusted therapy 46 of them are escalations in the therapy that is they're they're getting a more aggressive treatment protocol so one can infer from that that without the treatment The drugs that were being used previously would not have been as effective due to the resistance profile of the bacteria, and therefore the septic infection outcomes would likely to have been much worse. So I think this just speaks to the critical importance of using this, that half the patients are getting a therapy adjusted, and of the total patients, a quarter of them are being escalated to improve therapy to combat a resistant drug profile. So that, for us, really speaks to the mission that we're on with Gelinea to improve sepsis outcomes around the world. So, as I've said, on the back of all this, we're really focused on accelerating our commercial efforts. In the near term, it's really around building the pipeline in the markets that we're active in, both through our distribution and direct sales activities in the European market that we've spoken to previously, which we see continuing to generate good feedback, and we anticipate communicating some additional tender winds in the near future. But also, as I keep coming back to critically, the US market, where we're now fully engaged commercially, across the country. The U.S. market is the most important one just due to its sheer size, but also notably the U.S. is slightly more familiar with Rapid AST. There has been another solution on the market for a longer period of time, which has generated awareness of the technical feasibility and opportunity from Rapid AST, and we would position ASTAR as a next-generation solution with improved technical performance and improved opportunities for the lab. And therefore, we anticipate that adoption will continue to grow in the U.S. on the back of an improved solution available. As I said, we've got a couple early access programs ongoing. We've concluded agreements with additional early access candidates and are also now planning for commercial evaluation over the coming months. And our efforts don't stop with the existing ASTAR offering. Obviously, we're very pleased with what's on the market, but we continue to look to the next generation of offering over the next 12, 24, and 36 months. And really, we're focused on that expanded panel. So additional drug bug combinations, as I mentioned before, this will be an evergreen R&D topic for us as the world will benefit from continued innovation on the pharmaceutical side, bringing new drugs to market. That means we need to keep the menu up to date over time. So we will continue to follow the developments in pharmaceutical treatments available for patients and anticipate those. But in addition to that, continuing our mission to expand the offering into gram-positive and then the ability to use ASTAR for isolate testing and additional sample types such as urine, lung swabs, et cetera, which we're excited about the opportunity and we'll develop these over time. I'll speak more in just a second, but we are very proud of the innovations in Podler and some of the other proof-of-concept prototypes that we have for point-of-care and our Astrid direct-from-blood solution. These we see further down the road, so our R&D efforts have been prioritized into the ASTAR for now, but there's a lot of spillover benefits from the ASTAR work that we're doing into other areas. And in order to facilitate the development of Podler, we have put that into a separate company structure that christa can speak to in more detail this has received a third-party valuation of 70 million swedish crowns which speaks to the value potential here in podler which really promises to deliver a more efficient management of the blood culture and utilize any time of shipping the blood culture around between the point of drawing the culture where the patient is located and the lab doing the test, using that time already to culture the blood for the test, which has the potential to further reduce the amount of time between an alarm going off that a patient's at risk of sepsis and being able to give them adjusted appropriate therapy. So Podler is a benefit multiplier of the ANSTAR proposition and setting it up in its own entity here gives us the opportunity to work with additional third parties both for investment but also from a strategic perspective to bring this into the market. I would say that we are having conversations with customers on Podler and receiving positive feedback. There's interest here that gives us further motivation to develop the product. So final note there, as I mentioned, concluding the restructuring program with those benefits fully realized and seen in the P&L from July onward. And looking forward, you know, how we're allocating our resources, really concentrating on our commercial activities, especially in the US. While at the same time managing our R&D pipeline, we've reduced the overall investment into our development organization by around half versus our previous run rate coming off last year, but are nonetheless able to drive our priority programs in the R&D team. Then obviously we have a little bit of our keeping the lights on activities in support of the overall company efforts, but we've also been able to reduce our overheads through the restructuring program considerably by nearly a quarter. And then the other area that we are attentive of in terms of the use of our resources is the deployment of working capital as we scale up our sales activities, both in the form of instruments placed in the field where We expect in Europe, especially, a majority of the instruments will be placed under reagent rental contracts, which means we get paid over the duration of the contract, which can typically be between three and five years. And while in the US we do expect more capital purchases of instruments, there will still be reagent contracts in the US as well. So this will require some working capital. Krister and the team are already working on alternate options to finance that over time, as we will have signed contracts from customers that should enable some alternate ways of financing those. But nonetheless, something we need to be planful of in terms of utilizing our precious resources. And then, of course, obviously, the inventory and the account receivables accounts are expected to grow with the business as well. So with that, I think that's a good segue over to Krister. I'll ask Krister to speak to more detail on our financial results here from the quarter, and then we can turn it over for questions.

Krister? Thank you, Stuart. Thank you, Stuart. I'll continue with the financial section and start off with some financial highlights during the first quarter and after the first quarter. As Stuart earlier said, we have a cost savings program in place, a good start. We have an restructuring cost linked to that one of 5 million that will be taken before the half year, it will be taken in Q2. And then we expect the cost savings to have full effect as from Q3 and onwards, as Stuart said before, which is good. And we will shift the spending from development to more commercial. I mean, it's accelerated by the FDA clearance, also outlined by Stuart before. And then we have a decision to transfer the pod of technology. And we've done that in a separate company. It's also been valued at 70 million Swedish by an external analysis firm. And the effect on that one financially is primarily that it will strengthen the parent company equity with the same amount. And as published before, we have an additional loan facility offered by our main owner next to be. May 29th was Wednesday this week. It's subject to approval by the AGM in June. And we have, as before that, we had an existing facility of 41.5 million. This additional facility proposed is 60 million. All in all, that means that we have a facility from next to be of 101.5 million Swedish. As of March 31, we had 29.3 million cash at bank, which means that we all in all, including the 60 million that is to be decided on at the upcoming AGM, we have a total of 130.8 million. A little bit on our result. We have an operating result of minus 18.6 per month in the first quarter, amounting to minus 55.9 for the full quarter. It's better, 6 million better than last year quarter Q1 in 2023. Continuing and stepping into the consolidated status of the profit and loss for the first quarter, We have top line revenues. The 2.9 million can be split 50-50 between sales of instruments and consumables and other operating income, which we are glad to report. As I said before, the operating result was minus 55.9, and it's better than last year. I've already said that. And the improvement is primarily linked to the cost savings program in 2023, which was the first program. The program we have talked about previously here is the second program for this year. When they reported loss of the tax is minus 56. five millions better than last year. Earnings per share have a dramatic shift as compared to last year. This is, of course, primarily linked to the rights issue last year, when the number of shares increased quite a lot. You can see that it's 170 million now as compared to the 29 million last year. And as I said before, the cost savings program is already visible, but will full effect in Q3 this year. And the financial position, end of first quarter, some repeat some of the numbers here. Cash at bank, 29.3 million. The decrease, the average monthly decrease as from beginning of the year is 17.5 million. We have a remaining loan facility of 41.5 end of March. That's a total of 70.8 end of March. Also, we have inventories, fairly high number of inventories, the amount 43.5. But we are rather happy right now because a large part of that is instruments, which is suited well now in this early commercial phase that we are into, which means that we can deliver instruments fairly quickly and be aggressive on that side. The equity end of March is 133.8. which is 18.6 million average monthly decrease during Q1. As you can see here, the equity runway is longer than the liquidity runway, but with the increased loan facility, which was press released earlier this week, these two runways will balance. And then stepping into the future financing, and still, this will be repeating a bit of what I've said before, just to summarize where we are and how we see it. As I said, we have 70.8 million as of 31st of March. Out of the existing facility of 41.5, 15 million has been paid out 13th of May. Then we have the additional loan facility of 60, as I've said before. which means that we have a total facility 101.5, subject, of course, to the approval at the AGM. And the third thing I've said before, which we don't need to take again, and more importantly in the report, we have reported that we do not have going concern. We are in an early commercialization phase. We are FDA clear, which is very positive, and the pipeline or safe fund is growing in Europe and in the US. But we have to be engaged in finding other means of financing. And that includes strategic partnerships, capitalization of existing assets. Stuart mentioned Potter, which is, of course, is one of the assets we might capitalize on. And then, of course, to negotiate with new and existing investors, financiers and lenders is always an option. In the light of this, it is the board of directors assessment that the group successfully will be able to finance company operations going forward. That concludes the financial section. Stuart, I hand over to you.

Thank you, Krister. And that concludes our presentation portion of the event here. So I'll turn it over to questions.