Welcome to Q-linea Q1 Report 2023. For the first part of the conference call, the participants will be in listen-only mode. During the questions and answer session, participants are able to ask questions by dialing star five on their telephone keypad. Now, I will hand the conference over to CEO, Jonas Jarvius, and CFO, Christer Samuelsson. Please go ahead.
Thank you very much for that. Welcome everyone to our report for the first quarter in 2023. We go right into the presentation, but we start with our disclaimer slide in case me or Chris will make any forward-looking statements during this call. I will present a little bit high level of what we have seen activities in the first quarter. I will go in a little bit deeper on why we're developing the products we are and the value of those products. I will actually make a little bit of a resume of our actions that happened since Thermo Fisher, and we decided to end our partnership up until today, and then give a little bit a look on the future.
Here you can see on the first slide, we're basically summarizing what has happened. As you know, we're developing solutions for disruptive infectious disease diagnostics. We have been working hard during this first quarter to implement our new commercialization strategy. Part of that strategy is, of course, also to have sign-up distributors for key countries, also build our own sales force in selected regions. It's also very important to participate in customer-driven evaluations of ASTar. We have seen that this is a very important activity in order to support sales. We've also actually seen that the work that has been done last year is now actually moving on to tenders. We see the first ones coming out in Italy, and of course, we as a company hope that we can answer to those tenders and hopefully win them as well.
We also in February described that we did some additional testing on our 510(k) application for the U.S. market approval. This is, as you know, very common that the FDA asks for additional clarification, some more testing. I would say that it's not unusual. We're very familiar with that. We are in the very last phase of this testing to be completed, then, of course, we'll gather all this data and move them into an updated application here in the summertime. We've also announced a large cost-saving program that was after the period end. The focus is really to focus on commercial activities, but of course, also to have our funds last longer. We expect the savings to be around SEK 45 million annually, we are expecting to see effects already coming into place 2023.
We then move into a little bit on the importance of what we do. I mean, ASTar, the first product, is released for bloodstream infections, sepsis being the most severe BSI we have. We can see that even if you compare it to the most common causes of cancer, so lung, prostate, and breast cancer, the total death combined is lower than it is in sepsis. We also know that it's the number 1 cost driver in the U.S. healthcare system. There's an absolute and imperative need to improve the diagnostic for these severely sick patients. We also know that time to correct treatment is critical, and we see that if you move into septic shock, the survival rate actually decreases quite dramatically for every hour that you are on the wrong treatment. This is, of course, where ASTar comes in.
If we just look at the next slide here, we can see you have seen this slide before, but the world hasn't really changed. On the top part, you can see the traditional diagnostic workflow for septic patients, and you can see that it's a multi-day, multi-step process. The real problem is that for around 20% of the patients, they will have actually died before you get the current diagnostic answer on how to treat that particular infection. With ASTar, of course, what we want to do is change the workflow for the labs in the sense that they need to do very little hands-on time, less than 2 minutes, so very much fewer steps, but also of course, provide a broad answer on how you should treat that particular infection much, much faster.
What we have seen so far is that during our evaluations and early customers, we see that the system is very positively received. We can see that the coverage of our panel is very broad. Above 95% of everything you have actually loaded in ASTar, you've been able to act upon that result, and that's a very, very high number. That, of course, increases the value of the test if you know that the likelihood of receiving an answer that you can act upon is gonna be high. We also see that the use of the system is very simple, and people are very, very much liking the workflow of the overall system as such. Of course, why is this important?
Well, apart from saving money at the hospitals, which ultimately could be that you save days in the intensive care bed, the most expensive beds we have, we also know that we can fight antimicrobial resistance, which has been posed as the largest threat to mankind by providing more select and directed antibiotic treatment instead of broad spectrum. It's also life and death scenario. This is also an image we've shown before, but I think it's a very telling image. This is in Sweden. We don't have high resistance rates here, but it's just one case of an elderly gentleman who had neurosurgery, developed sepsis because of that, so nosocomial infection.
We can see that already the day after, you had a diagnosis with a positive blood culture, ASTar could deliver the same result and say, "Well, the current treatment that this patient is on is likely not gonna be effective." ASTar could provide options, with a much better outcome, and could also do that on 30 more antimicrobials compared to the traditional care. In this particular case, also did it much, much faster. This is the real reason, to have rapid AST, to be able to provide the correct treatment much, much faster than we can do today with our traditional methods. I go back to a little bit, going before the first quarter and also extending a little bit after. This is more or less a timeline of what we have seen.
Basically, we start the timeline in October when we jointly decided with Thermo Fisher to terminate our distribution agreement. That was really the starting point for us within the management and board to think about what's the best new commercial strategy, with what we have learned during 2022, but also how we think we can approach the market in a very effective way. That was really the starting point for that. Almost immediately in November, Nexttobe, our major shareholders, then announced that they provide SEK 100 million loan facility, which of course is, are good for the company, seeing that big support from our largest owner. As I mentioned, these customer evaluations, we could announce that we started one of them in December, and this evaluation is really comparing ASTar with other systems on the market.
Far indicative, I'm very happy with the results. We have to wait to the conclusion of that study. That's of course, going to be published by the site itself because Q-linea is of course not participating apart from providing ASTar kits to the study. In February was a very active period. There you could start seeing the first announcements from our new commercialization strategy. We signed a very important distribution agreement with Pro-Lab Diagnostics in the U.K. So far I'm really happy with what I've seen Prolabs engage in the U.K. market, how they participated in ECCMID, how they're actually working in the U.K. So I'm very happy about that partnership. We could announce full IVDR certification.
As you know, this is of paramount interest if you are gonna provide new products to the market and continue selling the products we already have. Then, as I mentioned, in my first slide, we announced the additional testing for the U.S. market. As I said, we are now closing up having the last samples coming into that before we can file an updated application. Also in February, we described our go-to-market strategy in more details. It's really a mixed strategy where we use distributors, where we see we have a good track record for certain regions and for other regions we extend with our own sales force. Primarily we want to go ourselves in Italy and the U.S. and also in the Benelux. In the other geographies in Europe, we would like to work with distributors.
Of course, a part of that strategy is also to have a discussion with a bit larger strategic players. I think we have very positive discussions there and see how we can move forward in those as well. At the same time as we announced our strategy, Nexttobe increased the loan offering with another SEK 100 million, so it now totals SEK 200 million. I think that really demonstrates the view Nexttobe have on the company going forward, and the belief in the growth of our company. If we move up to the end of the first quarter and into April, we can receive, or present another customer-driven evaluation, but with a more focus on clinical impact.
We know that it's very important to be able to guide therapy using the MIC values, so the concentration that kill or inhibit bacterial growth, and to be able to then select not only the antibiotic to choose, but also the concentration of that antibiotic. In the case where we have more resistant infections, actually knowing the MIC value can be very important for guiding that treatment in that particular patient. Also in April, we saw the first orders coming in from our work together with Prolabs. Of course, only be used both for demonstration purposes but also evaluations. Of course, that's gonna be important for future sales in the U.K.. Then we extended our partnership with Integra Diagnostics for the Polish market, and I'll come back to that.
I think that's a very interesting event rolling out in Poland as we can see it right now. Of course, we participated in ECCMID in Copenhagen, the largest exhibit for these type of infectious disease diagnostic tests, and of course, Prolab did as well. We had very positive feedback in ECCMID. We announced the cost-saving program. As I mentioned in the beginning, it's of course both to focus the company's resource and efforts to the sales to be able to do that efficiently and also, of course, to extend runway with current funds. What we have also seen over the past 4 month typically is that we have very strong support from a number of our key shareholders, and I'm of course, very happy for that.
We also see that a couple of other shareholders, for various reasons, have decided to sell shares in the company. If we just look at these are two big owners, putting out more than 1.5 million shares in the market. That of course, put an immense pressure on the share. We have a relatively low liquidity. We had that before. You can also see on the pink line, the value developing on our share. Of course, this does not mean that this share will be continued to be sold in the market, but I think that it's also to some degree an explanation of what we can see with the share price development.
When I see and look at the company, I really don't see that the value of Q-linea and its product has changed so dramatically over this period of time. This is my personal point of view, naturally. Another thing which is more of a tentative market outlook. I mean, you have seen our market outlooks before. If we assume that we have a CAGR of around 5%, which most market surveys support. We could see that the market for these type of tests for sepsis could be in the order of 20 million tests in the key geographies, mainly Europe and U.S., some degree, maybe 20% in the APAC region.
We have a very strict requirement saying that only around 20% of these tests will go into rapid AST system because you segment to charge patients, you might have contaminants, look at the current players on the market. This is again, my assessment that we have a handful of players in the market that support similar type of products or for them to the market. That would still equivalate to around 1 million tests each if we divide it equally among us. I think that when we look at the need for these tests and the size of the market, I think there's a huge market to be captured for these products. Of course, we as a company have an ambition to be best in class, of course.
Even an equal share and even a very strict requirement on segmenting, I think poses a very, very interesting market opportunity for the next coming years. If we then take a little bit look on our commercialization strategy, we can slowly see that Europe is becoming more and more orange. We have Poland of course now as well and U.K., and we are of course, actively in discussion with further distributors to extend the coverage even more. We are also talking to strategic partners if we can find a good collaboration, for instance. The strategy we set out to do, I think we are making very good progress in following that strategy. Of course, our goal is that this will then convert to additional sales for ASTar.
I said I would talk a little bit about Poland. I think this is very interesting for the field in general. We really see that this is the first country that now really commit resources. We know that, for instance, the U.K. have been a strong advocate for sepsis and education around sepsis. In Poland, we actually see that you now are putting funds to support the move and improvement on infectious diseases. The focus is within sepsis for this year, and the sub-focus will be rapid AST technology. Of course, very much in line with what we develop here at Q-linea.
This was really the reason we signed the partnership with Integra to be able to then, of course, respond to the upcoming tenders that we do expect to see in Poland over 2023 and onwards. I think it also demonstrate is that rapid AST is needed, and it's becoming prioritized. I really see this as very encouraging signal that maybe Poland could be the first country out, and I do expect other countries to follow, because when I look at the current care for septic patients, when I see the cost for them, the number of death, I can't see a world where in a number of years where every major hospital will have to provide some sort of testing capabilities for rapid AST.
I don't know if it's 3 year, 5 year, 7 year, or 10 year, but I can't see that that's not gonna happen. Of course, Q-linea want to be a very prominent player in that market. If we sort of summarize a little bit what I think we have learned, and some part is frustrating for me and of course also for you, is that we see that not just the sales cycle, but the purchasing cycle is also very long for the hospital. I mean, say that you have performed a very good evaluation at the customer site in April, They're not managing to get that into the hospital budget for the next year. It might still be very close to a sale, but it will take 1 year and a half more before you can actually have that tender be put out.
Of course, when you start selling a product, this is a really, really tedious process. When you're in it after a number of years in, I mean, then you close deals that you started a year and a half ago, and you start new deals that will be closed a year and a half in the future. This is really, very, very frustrating as we are right now. One reason for that is, of course, also that it's a new technology, and we see that everyone, and I actually would say everyone, every single hospital that we're in touch with would like to test the technology first and see the benefits. That's why these evaluations are key, I think for the early growth, of course.
In a couple of years, I don't think that everyone will need to test it because then you have enough data from colleagues in the field that you can sort of bet on that to move on instead. As I said also initially, we are actually now seeing tenders coming out, both in Italy and of course we expect to see it more in Poland, and also other countries. Slowly but steadily, we are making good progress. Of course, we have to win tenders to be able to make sales, but we think we have a good opportunity there. Apart from that, I mean, we have set up subsidiaries in Italy, in the U.S., we're hiring into those. In the U.S. we're also doing a lot of pre FDA activity before approval and starting up sites.
I think that's also gonna be positive for this year. I would say that, where I sit, I see positive on the future for the outlook for 2022... 2024. We said before the sales for this year, as we are moving into a new commercialization strategy, we are training up a lot of distributors. We don't expect sales to be massive this year, more on par with last year. Of course, we would like to beat that, but I think that should be the expectation. I think also after what we've seen now is that there is a clear interest and need for improved, rapid AST diagnostics. What we're doing is important and we are now starting to see that.
With that, I will move over to the financial part of the presentation and hand over the word to Christer.
Thank you, Jonas. My first presentation, I'm looking forward to it. I will make a brief presentation of the financials for Q1. Go through the P&L numbers and the financial position and the cash flow in three pages, starting with the consolidated statement of profit and loss. As you see, the sales amounts to zero, as Jonas has pointed out. Last year, SEK 5.8. We have a better operating result this year than last year, SEK 62.2 as compared to SEK 71.5, which is good. You can explain by lower external expenses or consultants, basically. Moving on to the profit and loss. We have a minus SEK 61.4, which is better than last year as well, as explained.
We have the earnings per share, also better, but still on the minus side, SEK 2.10 as compared to SEK 2.49. Moving to the next slide on the financial position. End of quarter, we have SEK 20.6 million available, which is lower than last year, SEK 72.9 million. We have an inventory on par with last year, basically. The equity has gone down from SEK 163 million starting this year to SEK 102.6 million end of quarter. We have a loan, which is new. We didn't have that at the end of last year. With SEK 25 million from our main owner, and it is SEK 25 million, but it's reevaluated based on the IFRS 9, and that is down to SEK 24.8 million. Moving to the next slide.
The cash flow. This cash flow is lower or worse than last year, basically due to an unfavorable change of working capital. That explains the whole difference, but it's partly offset with better operating result this year than last year. Moving on to the investing activities, it's all down to investments in production equipment. Rather low as compared to last year, in total also, but on par with the last year quarter. When you're looking at the financing activities, we have a SEK +23.2 million net, which is due to or thanks to the loan received by our main owner of SEK 25 million. That's basically what I'm going to go through. You can read it on the page down there.
Basically, what it says in the small print at the bottom of the page is that we have SEK 24.6 million on our bank, plus an unutilized loan facility of SEK 175 million, adding up to SEK 195 million in total at the end of quarter. The liquidity is not sufficient to cover our operations for the next 12 months. It's less than 12 months. I'm through there.
Thank you very much, Christer. With that, I'm gonna conclude our part of the presentation, and really show that we are still looking forward to the continuation of 23. We are expecting to see that a lot of work we have done since October will start materializing in further activities and respond to tenders. With that, I would like to close our part and open up for questions from the audience. Thank you very much.
If you wish to ask a question, please dial star five on your telephone keypad to enter the queue. If you wish to withdraw your question, please dial star five again on your telephone keypad. The next question comes from Gonzalo Gortazar from ABG Sundal Collier. Please go ahead.
Hi, Jonas. Hi, Christer. I would like to start with a question here. You reported in the previous quarter that the zero sales was a consequence of the Thermo Fisher situation. This quarter now in Q1, this should have improved a bit, especially in terms of consumables. What are the reasons for sales to remain that low? What about consumables? SEK 22,000, it's a quite low number. What can you say there? Thank you.
Thank you, Gonzalo, and hi. No, I think that's a fair question. The reason that we don't see sort of instrument sales, I think is very much expected, during the quarter because we are setting up a new commercial organization and we need to have that in place. That is not a surprise. We also said in the last presentation that we do see the sales to be backloaded. When it comes to consumables, as you know, typically a customer will buy, books of consumables, and how often they will buy them can be very stochastic, depending on utilization of that system particular. I think in that case it was more that, what you can see, which is not uncommon, is that you tend to stock up a little bit at the end of the year, for various budget reasons.
That means that the first quarter, traditionally in sales for consumables are the lowest quarter. I don't see it as a big surprise. Of course, as I said, I do expect the rest of the year to change in a more positive direction regarding sales.
Okay. Okay. A second question. You have implemented now, I mean, not that long ago, a cost-saving program. You reduced your workforce quite substantially. How is this going to impact the development of your own sales force, let's say, for the Benelux and Italy regions? Is it going to happen slower than what you thought last quarter?
No, not really. What we have done is really restructuring the company. Where we have decreased is primarily in the development part. I mean, as you know, we have that very long, long-term and development plans. We're now focusing more on the ASTar success. We don't see this affecting the sales force or our sales strategy. We actually do that to be able to put the resources in sales instead. Of course, what it also means is that some moreForward-looking development projects are being paused. Of course, we're going to restart them again, as soon as we find that feasible. This all cost saving is really, changing the company to be focused on sales, and perform all those performing activities.
We do not see any effect on the sales for this year because of that restructuring.
Okay. One last question. You mentioned, well, a few weeks ago and now in the report that Prolab has placed an order for two instruments that will be used as demo instruments in exhibitions. My question is, I was wondering, how much are you going to guide in the future for ASTar placement? Is it something that you will be guiding on a continuous basis, or how can we expect this in the next quarters?
I think it's a good question. I think with two parts. We will guide more on the quarter report, of course. I think as I said also earlier that during these years when we do see that we either win a tender or place true customer evaluations, we will most likely press release that. We are more transparent to the market regarding those activities. Hopefully, would be that in a year or in a year half from now, we will go back to only keeping it in the quarter reports. As of now, we will be more active in that communication. As I said also, I think it's important to still expect the year to be more backloaded because of course, setting up a new distributor, there's a lot of training activities.
They need to go out and approach the customers. Even looking at having worked a couple of months is very little time. We do expect to see that, and we are gonna be much more open with that. My guess, my answer is press release during this year and then going back to quarter releases when we see that we have a more of a steady flow. It's also easier for everyone following the company to see the progress we make in these areas.
All right. Thank you very much.
Thank you.
As a reminder, if you wish to ask a question, please dial star five on your telephone keypad. The next question comes from Johan Unnerus from Redeye. Please go ahead.
Questions. A few then. Is it possible to say anything in regard about how many systems that are paid for test for evaluations right now?
I think I heard you a little bit bad, Johan Unnerus. Hi, by the way. If I repeat the question, I think that your question was really how many systems do we have out for evaluations and testing. We haven't announced that precise number, but we have several instruments in Italy, also several in the Benelux areas, and we're also having instruments in the U.K.. It's currently, I would say less than 10, but it's between that five and 10 type systems that we are currently doing evaluations on.
Excellent. That's helpful. What about this savings or priority program that is, you're going to, roll out, SEK 45 million in savings, when can we see that effect? Should we see the most of that effect towards the end of the year on the run rate or is it further into 2024?
I think that first of all, yes, we see that as a steady state effect in 2024. With the current plans we have and see it, we do expect to see that already in the last quarter to see those effects coming into play.
apart from this program, is it other savings or priorities changes you are thinking about doing?
Well, I think, of course, what we're doing is really focusing on the sales-driven activities, both in development and of course in the commercial team. That's the primary focus. Really, I think the team at the company has done a good job in the restructuring of the company to really have a solid organization that in the future could grow in the commercial aspect. We don't really see or plan to do more savings on this. I think this is a good program, and we expect to see them coming out already this year and into next year. This is the primary reason.
Of course, what we are looking at for in the climate are thinking that some of the projects that we might put on pause, are we gonna try to find some different type of business relationships or agreements with them. That is something I can't go into more detail, but that might actually be one opportunity that's not necessarily saving, but it could look at a different type of income coming in earlier from post projects, so to speak.
Yes. Of course, it's very important with launch preparations and I'm thinking about the U.S. rollout eventually. Of course, the first step is to re-submit fully then towards possibly June. What are you thinking about stepping up the launch activities or preparation for ahead of the launch activities?
Right. No, that's a good question. What we're doing is we're first of all in late stage hiring our commercial leader for the U.S. We have had very good candidates, and we expect to come closer to an agreement on that, ideally before ASM, which is mid-June. What we're also doing is we are now moving forward with these pre-FDA approval evaluations. We are moving forward with one in Washington. We're having several discussions ongoing with additional pre-FDA evaluations. I think the interest we have seen there is very positive.
What we're trying to do is prepare the market, at very good hospitals, key opinion leaders to be able to run evaluation studies, of course, R&D studies at that stage before approval, so that the product will actually have some traction already, when we see the clearance coming from the FDA. That's what we're doing. We try to manage how many we can run. So far, I think it looks good for the U.S. market. Also very positive that a lot of the feedback we receive from tentative customers is that they absolutely, love this full automation, 24/7 operation of ASTar. That's really been important after the pandemic.
I think that what we have designed and built, might be even a better fit for the U.S. market, although it's still a good fit for Europe.
During 2023 then, to close that hiring, and to start a number of evaluations ahead of approval in the second half, and a slight buildup to support these evaluations commercially, clinically. Is that what we should expect, roughly?
Yes, exactly. Yeah. That's what you can expect.
In the report, you are pretty open about that you are evaluating and considering different growth capital alternative. Of course, it, it is a necessity to address this situation. Is there anything more you can add to that?
No, you're not, not in detail. Of course, you're absolutely right. I mean, you can just look at the financial statement to see that. I mean, I think, first of all, we have a very strong support from Nexttobe, and I think that's very clear. We're also actually seeing some market traction coming in. What we are doing, and of course, what the board is always assessing is what's the best next step for the long-term funds of the company. There are several alternatives and discussions ongoing. I look very positive on that, to be honest. I can't go into the details. Some are, you're probably very familiar with. There might be also other alternatives on the table.
Okay. That's all from me. Thank you.
Thank you very much, Johan.
There are no more questions at this time. I hand the conference back to the speakers for any closing comments.
Well, thank you very much for that. Thanks for listening in. I do hope you continue to follow us. I do hope you share your view that Q-linea is an exciting company and that we are gonna turn this boat around. I'm confident in that. Keep following us, and we'll be in touch at least for the next quarter report. Thank you very much from us.
Thank you.
Bye-bye.