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Earnings Call: Q1 2022

May 5, 2022

Operator

Ladies and gentlemen, welcome to the Q-linea audio call for teleconference Q1 2022. Today, I'm pleased to present CEO Jonas Jarvius and CFO Anders Lundin. For the first part of this call, all participants will be in listen-only mode, and afterwards, there will be a question and answer session. Speakers, please begin.

Jonas Jarvius
CEO, Q-linea

Thank you very much for that introduction, and welcome everyone to our presentation for the first quarter of 2022. I think we start with moving to the next slide, showing our disclaimer slide, in case I or Anders will make any forward-looking statements, as you have here on slide number two. I think we move into the activities for the first quarter on slide number three. Of course, you who follow us know that Q-linea is working with developing disruptive solutions for faster infectious disease diagnostics. We have a product on the market. We'll talk about that today. It's ASTar, and it's targeting bloodstream infections, where sepsis is the most severe of these syndromes. We are based in Uppsala, Sweden.

We have three sites, active sites with covering R&D, of course, commercial activities, but also production, because we focus on production on our consumables. You can see that on the right of your screen, where you see ASTar being the instrument platform and then the various kits, for different type of applications. To summarize on a high level, the first quarter, we have been growing according to plans. We are close to 180 employees and consultants. You can also see that our growth trajectory is now slowly leveling out. We are at the phase now of more or less consolidating and moving on with the company according to our earlier plans. We can also welcome our first commercial customer for ASTar. Very happy about that, and of course, come back to that.

We also see a very strong demand of commercial opportunities for our system. It was, as you know, officially released and launched by Thermo Fisher Scientific, our partner, of October last year. We are very early on in the launch phase still. We're also coming back from ECCMID, I mean, the world's largest infectious disease conference. It was in Lisbon this year, and it was a very successful conference for us for sure, but also for Thermo Fisher Scientific. Another big happening during the first quarter is that FDA, Food and Drug Administration in the U.S., awarded ASTar with a breakthrough device designation. Of course, we'll come back to that as well.

We are also, as you know, pursuing with our next product in development, Podler, a fully automated blood culture cabinet that can really save time in transportation, and we are moving on with the commercial discussions there as well. What have we seen then, this very early stage of the launch? While we can see that the sales cycles are long, they are in line with what we see from other companies in the market with similar products. We also see that we have a very positive feedback of customers that do evaluate our system. We also see that currently we have a larger demand of customers wanting to perform an evaluation than we currently can handle. Of course, that's a capacity that needs to be built up. We actually do provide some guidance for this first year.

We have guided around 20 ASTar sold during 2022. I think it's that important to remember that it was launched in October, and we had very short time to launch the product so far. If we just move in to slide number three, looking at our focus within Q-linea is, of course, addressing the current need for infectious disease diagnostics, sepsis, as I mentioned. The leading cause of death in U.S. hospitals, the number one cost driver, kills a lot of people, Europe and U.S., every year, and in the world, a person will die every third second. The big problem with sepsis is that it's a very rapidly escalating syndrome, and it's caused by you having a bacterial infection that leaks into the bloodstream, and it can then trigger an overreaction of your immune system.

Of course, you need to fight that underlying infection, and the primary course of treatment is, of course, antibiotics. The problem is that the current diagnostic workflow for sepsis is long. Around 50% of the patients are on inappropriate treatment. It might be too broad, it might be also ineffective treatment. That is also the reason that approximately 20% will die before the traditional diagnostic results. This is the focus for ASTar and our first product to dramatically save this timeline before you get the correct treatment. We're also a company that works with the future in mind. As you do know, antimicrobial resistance is one of the biggest threats we have to mankind. It has actually been presented as the biggest threat to mankind.

It's really coming from over-excessive use of antibiotics over a long period of time, meaning that bacteria will develop resistance and become harder and harder to treat. Of course, the future looks rather gloomy unless we act and do something right now. Of course, what we do at Q-linea is providing one piece of the puzzle with, of course, our ultimate goal that our kids, the next generation, should be able to have the same level of treatment, high-quality treatment that we have received or our parents have received. I think the future where we operate has very strong and interesting outlooks.

If we then move on to slide number five, it's also bringing a little bit of both ASTar in context, but also Podler, our portable culture cabinet, where you can see on the upper part, you see the traditional workflow for septic patients. It's a multi-day, multi-step process. It takes sometimes three to four days before you can have the appropriate correct treatment for each and individual patient. In the lower part, this is, of course, what we want to address with ASTar. Much faster time to action the results, meaning that you do know what bacteria is causing the infection and what antibiotic that you should use. More so also what concentration of antibiotic to use. We have a very broad panel in our product, and that of course means that it's very easy to run in parallel with the identification methods.

You don't have to wait for ID, and that is, of course, also important to really reduce the time to optimal therapy. When we look at Podler, it really addresses the step from the site of sampling of the blood culture until it arrives in the lab, and that can take somewhere between one and 24 hours. Of course, those hours are hours lost in the diagnostic workflow. If we take a look at the next slide, number six, this is just a summary of three independent health economic reports that have looked into what could the benefits be if you could be one day faster or 24 hours faster compared to the current diagnostic workflow. I think the effects are quite dramatic. Reduced mortality quite dramatically.

Of course, also, if you have the possibility to choose a narrow- spectrum antibiotic faster, you reduce the pressure for resistance development in the patient, hospital and society, and that could also reduce the super infections. Of course, also for the hospital, a septic patient that move into a more severe condition, septic shock, are being treated in intensive care units. Very expensive bed, a lot of staff needed to keep that patient alive, trying to bring them back. This study showed that you could save on average two days in the ICU bed. The overall drivers, when we look where we are today and in the future, is very strong for the individual patient, for the hospital and society regarding both development and cost.

I think that the future looks very promising for rapid AST overall. If we move into slide number seven, I will not go into the details on this slide, but ASTar has really been developed with customers, together with customers. We have four pillars that we, together with our customers, deemed that the most important for this type of new technology needs to be easy to use, fast, of course, obviously, but also comprehensive, so you can actually act upon the result, and you don't have to wait for a follow-up test, for instance. It also needs to be accurate. When we talk about resistance testing or susceptibility testing, what's becoming more and more important today is you have the MIC value, and that is the concentration that kill or inhibit bacteria.

As infections become more difficult to treat, the MIC value can actually be used to guide the treatment, so the dosing regime, the timings and so on. ASTar, of course, provides that as well. If we look at slide number eight, if we take a high sort of overview of these four pillars, we can see that the testimonies we have and also the feedback now we receive from customers evaluating ASTar or have even decided to purchase the system is that it's super easy to use. It's easy to integrate in the workflow seamlessly, and anyone at the lab can really run an ASTar with minimal training. I think we are now moving away from the pandemic, and we have really seen all the work and effort that this staff needs to put in to do testing.

Of course, having an instrument platform that anyone can use 24/7 really optimizes the need for personnel, but of course, also means that you can use it throughout all hours of the day. If we now look at the slide number nine, this is just some highlights on the CE-IVD study that we finished last year. We are, as you know now, moving into the U.S. study and finalize that. On all the aspects where you are required to deliver results to be approved in Europe, likewise in U.S., ASTar overperformed but was well above the requirements needed to launch a product.

When you look at other colleagues or competitors in the field on the lower right, you can see that the breadth of our panel, meaning that number of antimicrobials, the concentration ranges to provide these very important MIC results, is very broad. It's actually the broadest panel available right now. That, of course, mean broad panel, you have a high likelihood that you can act upon the results. That of course, bring the value to the hospital, the lab and the patient. If we move into slide number 10, we have also designed the instrument to address various workflow, and we also presented this at ECCMID this year. You can run it fully automatic, as we talked about for blood.

For other type of samples such as isolates, you can actually also run the system with only AST disc, and this is now under development. Of course, this will address different price points and different volumes. We've also built ASTar in mind for medium-sized and up hospitals, so high throughput, all random access, to be able to handle peak loading in the morning, for instance, but also high sustained throughputs. If we then move into slide number 11, we're coming into more of the highlights for the first quarter. I would say that of course, we are early on, but to be able to welcome our first customer in the U.K., it's a great success.

Customer performed an evaluation and then decided to invest in the technology to serve their lab, their hospital with providing better care for the patients. What we have seen, or both ourselves, but also, of course, our partner Thermo Fisher Scientific, is that there's a strong interest for ASTar, and there's a strong, rapid interest for rapid AST. We have a sales pipeline is growing. We also see that it is a young and early technology sale. Customers at this stage would like to evaluate ASTar in their lab. I mean, running it as they would do in a sort of commercial normal operation before they actually take a decision to buy it.

If they do so, we see that the sales cycle, because of tenders, the way we have it non-Europe is approximately nine months. This is all in alignment with other companies in the field. Of course, we're now looking into are there possibilities to shortening the sales cycle. That is where we are today. Also due to the fact that customers would like to evaluate before they make a purchase, we see that currently today, our part of Thermo Fisher Scientific has limited capacity. We really look forward to see that capacity grow. Of course, this makes sense. I mean, when you start launching a product, you have an idea on what's needed, but then you have to test that in the market, and you have to adjust according to demand, and this is fully natural.

Coming back to my first slide, this overall estimates that around 20 sales for 2022. Of course, we really look forward for 2023 as well, when we also add U.S., coming with gram-positive and even increase the value of the product. If we then take a look at slide number 12, I think this is truly important, and I think that everyone following the company should be very happy about that. ASTar is now classified as a breakthrough device by the FDA. Now that means that FDA see a value of our technology to provide better and faster care for U.S. patients.

Of course, the value of that is, in our opinion, not only a sort of stamp mark that it is a high- quality product that brings a value, but also as we are now in the really final step of our 510(k) submission for the U.S. market, the breakthrough device designation could help us reduce the time until clearance for the U.S. market. Of course, that's also very positive. I think also a lot of U.S. customers see the value of breakthrough. I think it will actually be a positive also when we do launch into the U.S. geography.

If we then take a look at slide number 13, just after the period end, of course, we participated in ECCMID, the Infectious Disease Conference, and the interest in ASTar and the other products in development was very, very strong at the conference. Both our booth and of course, Thermo Fisher Scientific booth were fully occupied with demonstrations of ASTar's, people asking. We have a strong list of leads, at this stage for both companies to follow up after ECCMID. Of course, that's gonna be a very exciting period now for the next month to come to see how can we, capitalize on the value and the interest that we both saw at ECCMID. Apart from ASTar, Q-linea also presented the development pipeline for the product. We presented our tentative gram-positive panel, again, including fastidious, non-fastidious bacteria.

That's unique if we manage to have it all the way to the market, but we, of course, strongly believe so. We also presented for the first time a AST disc-only workflow for isolate testing, meaning that you can find that at different price points, also very positively received. I think when we talk about Podler, our portable blood culture technology almost went viral. We had a huge interest, people coming into the booth, bringing more people into the booth. Really, the question asked, why has this not been developed before? I think the entire Q-linea and Thermo Fisher Scientific team are really excited coming back from ECCMID, seeing the interest from both customers but also potentially new customers.

The next slide, number 14, this is just three images where you can see on the top right-hand side, a busy activity in Thermo Fisher booth. People are actually standing in line to have a look at ASTar, and that's very positive to see. Likewise, you can see, on the lower two images, the Q-linea booth, where we presented really the workflow from A to Z, the way we manage it, and how our products on the market and in development can really meet and change and transform that workflow, coming forward. Super excited. Of course, we're now moving towards ASM, a similar conference in the U.S., mid-June. We'll come back with that in the next quarter report.

Finally, on my part on the presentation on slide number 15, we still want to manage the corona pandemic. We are moving back to normal operations, that's for sure. We still see that there are some possible effects of the corona pandemic. None of us know if you will have a more aggressive variant coming up in the autumn, for instance. Of course, we can see that there are still some residual risks. Overall, most part of the world are moving back to normal, at least from a customer perspective. We still see that shortage of components, there's a risk. We see that there's lack in transportation, manufacturing of some components. Internally at Q-linea, we have built the safety stock, and we're, of course, looking into this, very carefully.

I would not say it's over because it's not, but we do see it's moving back in, into the right place. Concluding my part of the presentation, I will now hand over to Anders to talk about the numbers as well.

Anders Lundin
CFO, Q-linea

Thank you, Jonas. I will start on page 16 and share some of the financial highlights we had during the first quarter. We reported our net sales for the first quarter at about SEK 5.8 million. We have cost of goods sold of SEK 12 million, and we have an operating result of close to -SEK 72 million. We reported about the same -SEK 71.9 million as a loss after tax. The EPS before and after dilution were -2.46 compared to -2.34 last year's same quarter. I move into page 17, balance sheet. That is a list of what we have in available funds. We have cash and cash equivalents of SEK 15.4 million.

We have both short-term interest funds and listed bonds, both short-term which are due within 12 months and also non-current listed bonds which are due in 12+ months. We have inventories in stocks of Astrego and consumables, raw material of SEK 21.9 million, which is a decrease from year-end where we had 28.6 million. Included in those numbers is a write-off, which we have done of - SEK 5 million. If I move on to slide 18, that is highlights from our cash flow statement first quarter. We have operating activities are slightly better than last year's same quarter of -SEK 51.7 million.

The reason for that, even though we had operating results which were lower, we have improvement in working capital during the first quarter that offsets the negative operating results compared to same quarter last year. We have investing activities of SEK 52 million, meaning that we are net divestment of both short-term interest funds and bonds to support our need for working capital. We have a small, we have some repayments of loan of SEK 40,000 in the financing activities, small numbers. All in all, by the end of the quarter, we have SEK 290 million in available funds compared to the SEK 348 million by the year end.

The board's assessment by having those available funds is that the funds will cover the working capital for the next 12 months, at least. By that slide, I would like to hand over to Jonas.

Jonas Jarvius
CEO, Q-linea

Thank you very much, Anders. That was really our last slide for our Q1 presentation, but we'll be happy to open up to any questions from the audience.

Operator

Thank you. If you do wish to ask a question, please press zero and one on your telephone keypad. The first question comes from Ulrik Trattner, Carnegie. Your line is now open. Please go ahead.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. Thank you very much and good afternoon. I have a few, if I may, and please cut me off if there's too many of them. We can start off with personnel costs. They look to be up quite substantially quarter-over-quarter. Any explanations for that? Is that an expected future run rate?

Jonas Jarvius
CEO, Q-linea

Yeah. Thank you very much, Ulrik. No, I wouldn't say that they are up dramatically quarter over quarter. I would not say that. We did, of course, do a lot of production scale up, sort of last year. The way we look at the future right now is that we are sort of not necessarily leveling out, but we are more at that level now. We feel that we are in a good place for the company to do all our activities. I would not say that I would see the same type of increase as we have seen before in the past in our buildup of the company. We are more. I would say we are more coming to a steady state more or less, regarding that.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. If we can address the guidance of the 20 ASTar systems for 2022. It sounds based on your comments on the selling process lead times that we should not interpret that U.S. is part of those numbers of the 20 ASTar system. As well, if I'm doing some backtracking, it sounds like these 20 systems must then be based on sales made from first commercial launch in October last year to end of this quarter. Is that a correct assumption?

Jonas Jarvius
CEO, Q-linea

Now I would say, first of all, yes, U.S. is not sort of included. It’s not an approved market just yet. Also with the long sales cycles, you are right, Ulrik. It’s a lot of work up front, and then of course, you can see the benefit of that coming up. We are of course also looking together with Thermo Fisher Scientific if there are ways to shorten it. I would say that at this stage of the launch, looking at our other colleagues or companies in the field, we are more or less on the same page. I would agree to your comment there.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

A follow-up on the lead time and evaluation. As you're stating, these could potentially be shorter. What would be a normalized situation? And could we see these improvements already towards the end of this year? As well as on these evaluations, what's your current win rate in terms of once you have done a demonstration and an installation of these evaluation customers, how big a portion of those are then converted into true commercial customers?

Jonas Jarvius
CEO, Q-linea

Right. Maybe I'll ask the last part of the question first. I will not provide you with an exact number, but I would say that so far it's very high. We are very much, and I think that's also why we are really very positive on the future that people that try us are in their lab and see how it performs with workflow results are very positive to move forward with the system. You will never have 100% for good reasons. You might also have an evaluation with a very satisfied customer that maybe not have it in their funds for this year, but can allocate it for next year. So far, I would say that it's a very high number, and I'm very glad about that.

I think when we look at evaluations, I mean, rapid AST is still a young field in Europe. I think we must say that. I think U.S. is a more mature market, so it's gonna be interesting to track the development in the U.S. I think that until we come to a place, maybe that's a year into the launch or something like that, when we have a number of installed base of instruments at good reputable labs, where people can actually see how ASTar performs at their colleague's lab, for instance, then I think we can move away a little bit from try before you buy, in a sense, and actually buy on reputation or colleague recommendation.

I think that could be started to see maybe end of this year to give some guidance on that. It's gonna be interesting to follow, I would say. Today you really want to see it and have it in your lab, see what it does or what it can do for your particular setting. So far people are very happy when they have evaluated ASTar. I'm very positive about that.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Could you say something about who this first commercial customer is? What type of hospital, where it's located or anything?

Jonas Jarvius
CEO, Q-linea

Yeah, I could, but I'm not allowed to, Ulrik, not just yet. I think that you will see all the publications coming out from this site and lab, and I would be happy to share when they are becoming more. I think also what's important at this phase of the launch, I think that when you look at the customers, I mean, sometimes you want to have a customer with a very specific reputation for reason, not necessarily the biggest lab perhaps in a site. Then of course, you want to see a mix with more of these large university hospitals, which are more of a pull- through volume type drivers. I think in this sense, I would like to see a mix for a couple of reasons.

One reason you would like to see a mix is first of all, how that could help drive the sales, of course, obviously for more installments, but also to be able to align and tweak where do we or Thermo Fisher Scientific needs to put more resources in our sort of, let's say, priority customer, if that's even a word, but it's more like that.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Okay, great. Is there any possibility that you can provide us with the revenue split between consumables and systems? Is that something you are planning to have in your quarterly reports going forward?

Jonas Jarvius
CEO, Q-linea

Ulrik, not right now. I think that this is the first time we guide the market, of course. I said that we are gonna be as transparent as possible. I think we should give it some time so also we can provide some proper guidance on that. I think it's still very early days, so I don't think you will see it in the next couple of quarterly reports for sure. We'll see that in the future where we end up with. Of course, it's an important split for sure for the future.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. Three more questions. These are short one, I promise you. If we can talk a little bit about you mentioned the AST disc only. What would be the benefit of having an ASTar with an AST disc only, since it would be then compared to other semi-automated systems, you have your Specific, bioMérieux, et cetera. What would actually be the benefit of using an ASTar with an AST disc only?

Jonas Jarvius
CEO, Q-linea

Right. First, of course, I mean, customers will initially buy ASTar for our blood culture testing. But when we do look at our panel, yes, I see it. As you know, it's the broadest capable panel out there today with a number of antibiotics and dilution ranges. We do know that we see customer, this has actually been a comment coming from customers, is that for some isolates, for some samples, we know that the current platforms out there today do not provide sufficient answer. We think that if you have an ASTar in the lab and you have a very broad capable panel, I'm pretty sure that for a number of samples, you would like to go to the system that provides sort of the most complete coverage.

I would say that the benefit is really that if you step into the world of ASTar, you can then broaden that with more difficult samples where you, for instance, see that, I mean, we have Pseudomonas, for instance, on our panel. We don't see that in many other systems. That might be one approach. We also have colistin. We don't see that performing necessarily perfect on all platforms. I think that would be sort of a stepwise approach into that. I think also ASTar is built with a high capacity for good reasons, and one of them is to be able to grow into other type of applications. Isolate being one, it could be urine, for instance, respiratory in the future.

I would say that the value of that we'll see in the future, but that's the thinking behind it right now.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. Last question on ASTar and then one question on Podler, U.S. clinical study. What is remaining in order for you to file? It sounds like you're in the final stages.

Jonas Jarvius
CEO, Q-linea

Yes. It's putting all the paperwork together, the last pieces of that. It's still some work to do, but it's really at the home stretch, so to speak. We said during the spring. The spring has been fairly cold in Uppsala, but not too far away. I think also of course, we're really happy with the breakthrough device designation that we do hope could provide a good discussion with the FDA. Of course, ideally we would like to see the possible clearance of our ASTar coming a bit faster than if we didn't have the breakthrough device.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. Thank you. Just one on the Podler. You mentioned from ECCMID great commercial interest in or great interest in commercializing Podler, so to speak. Could you provide us with some clarity in terms of when you will decide on what and how you're going to develop Podler? Is that something that we could expect during the fall in terms of if you're going alone to the market, if you're aiming to find a commercial partner, is it going to be a co-development partner? Just some more clarification on that would be helpful, please.

Jonas Jarvius
CEO, Q-linea

I would not probably be able to provide maybe the exact details. I think the direction we're gonna go, we should be able to present that during the autumn with the current thinking. We'll provide some more flavor on Podler in the next coming quarter reports. I might not be terribly exact on the necessary if we decide to go with a partner, what that is, maybe early on, but we'll see. We'll have to keep that a little bit as a cliffhanger, but the interest was amazing, I would say. Very seldom seen, I would say, in this field as we operate in. I think the entire team came back with a big smile on their face.

Not just Podler that was unique, but also ASTar. ECCMID was really good for us this year.

Ulrik Trattner
Equity Research Healthcare Analyst, Carnegie

Great. Sounds exciting. That was all from me. Thank you, both Jonas and Anders.

Jonas Jarvius
CEO, Q-linea

Thank you, Ulrik. Thank you very much.

Operator

The next question comes from Jakob Lundén, ABG. Your line is now open. Please go ahead.

Speaker 6

Hi, good afternoon. I have a few questions, and I'll take them one by one. I'll start with a question on the guidance, and it's a bit below my expectations, and I understand that, I mean, we might have sort of underappreciated the longer sales process. But can you say anything about something that can give more of a sort of feeling for the ramp up after the 20 systems this year, perhaps maybe on how the customer interest is developing or the number of customer evaluations, if they are growing, for example?

Jonas Jarvius
CEO, Q-linea

Yeah. So first of all, good afternoon, Jakob. No. Well, I mean, yes, the sales cycles are longer, and you're right. I think also when we look at is the full sort of commercial launch started in October, coupled with a long sales cycle. Of course, it doesn't follow a fiscal year ideally, so that could have been different. I think that today I would not do that. We are talking with our partners at Thermo Fisher Scientific, and I think that we develop together what type of guidance we'll see on number of leads and prospects is something that we have to internally communicate and then perhaps come back. What I do see is that as we also mentioned, that there's a high list of prospects and leads for the instrument for our ASTar.

We also see that we have a large demand for testing it. I think that as soon as we can, we'll of course provide some more flavor to it. Also, as I mentioned a little bit previously, I think that there's gonna be an inflection point sometime where you see customers more talking to other customers for our ASTar. That could be a sort of a different slope on the curve. I think also when we look into coming up into the U.S., which is more familiar with rapid AST, and also more consolidated market, I would say overall, many more 24/7 labs. I mean, basically all of the big ones are there.

I think it's also gonna be interesting as we come closer to the U.S., then we can compare and contrast the European launch strategy and sort of, turnover success, timelines and so on, and then versus the U.S. That's what's gonna be extremely interesting to see when we come closer. I will not provide any more detail today. I think it's the first time we actually do provide guidance at all, which I think is appropriate where we are right now. Yes, of course, everyone would like to see more instruments, we as well. I think also when we look at it objectively, today, this time is not unique for us. It's more or less the same, with all the tender processes and everything that needs to happen now in Europe before a sale.

Maybe not the exact answer to your question, Jakob, but at least giving a direction of what to think about in the future for how it can change and when, and also in other markets.

Speaker 6

No, I understand. The guidance you have given today is of course very helpful. My next question is on the cost of goods sold. I would just like to have some more sort of flavor on if it's the consumables or instruments that are mainly at the low volumes and contributing to a negative contribution and also maybe if you can give any sort of indication on the timeline or volumes needed for contribution to be positive.

Jonas Jarvius
CEO, Q-linea

Right. My sort of perhaps answer will be that of course everything is at low volume to be honest. I mean, instrument and consumables at this rate. I think that's very natural at this phase. When we look at the market, I mean, we have some Europe, USA, 5,000 potential customers, maybe not all for ASTar. They are performing some 70 million tests. Of course, the key driver going forward will be to see a ramp up on the consumable, which I think overall will be the main key driver for the field. Also, when you look at margins, for instance, of course, instruments will not sit at very high margin overall in this type of field. You'll put all that focus on the consumable.

As of today, I will not provide an exact volume or EBITDA. Of course, in this phase we are not really expecting to have positive margins. As we see volume pick up, of course, that's gonna be a key number to change, of course. Also, can you add to that, as you also know, what we are doing in the company and did also last year is we are investing a lot in scale-up capabilities, primarily in the consumable field. The instrument, we have a high capacity, or Sumetzberger, they have an appropriate capacity for that. We do invest now, for the future also, on the consumables of course.

Speaker 6

Okay. My next question is on the sort of recent deals that has been in the AST space where Sysmex recently acquired Astrego, and we also had bioMérieux acquiring Specific Diagnostics here as a couple of weeks ago. Has this impacted your discussions with Thermo Fisher, perhaps?

Jonas Jarvius
CEO, Q-linea

That's a good question. What I can comment is that it's exciting times, right? I mean, we are seeing some of the big players moving in. Of course, what I think that can indicate to another shareholder in Q-linea is that the big companies sees value in rapid AST. This is something that's needed, that's coming. We have seen a couple of companies now taking the firm stake in this field. I mean, Sysmex is more towards UTI testing, but it's still rapid AST, very important. I can't comment on any other of the discussions internally, but I do think that it provides an overall view of that the field is becoming not mature, but at least it's clearly addresses as an important field.

I can say that.

Speaker 6

Yeah. I agree that the bigger players are now increasingly securing their positions. Would you say that these deals and perhaps more on the specific acquisition will have any impact on the sort of midterm rollout of ASTar, you think?

Jonas Jarvius
CEO, Q-linea

I don't think so. I mean, for a couple of reasons. First of all, I think it's extremely good that we see, for instance, Specific Diagnostics, now we have Gradientech, because at this stage, more companies that talk about rapid AST, more customers that are presented with rapid AST solution, it increases awareness. I mean, to me, actually, I don't call a company a competitor until I lose a sale to them, then they are a competitor in a sense. You might of course be competitor earlier on. When we look at the young age of this field, I don't see it will affect the rollout. This is of course my personal opinion. I think actually it can be positive.

I also do think that the value proposition of ASTar, the way the system is designed, what it delivers, becomes also very much more clear when you can truly compare and contrast it with something else. That makes it easier for the customer to find what's gonna suit your needs. I would say that overall, the move in the field is positive, because it indicates that it is an important field for sure. More awareness around rapid AST, I think is beneficial for all of us. I think it's good. But I would not say at this stage that we see any limitations, really. I might change that view, but not today.

Speaker 6

Okay. Thank you. That was all the questions for me today.

Jonas Jarvius
CEO, Q-linea

Thank you, Jakob.

Operator

The next question comes from Johan Unnerus, Redeye. Your line is now open. Please go ahead.

Johan Unnerus
Senior Life Science Analyst, Redeye

Thank you and congratulations for the interest in Astrego. Also, I think it's very appropriate and wise to give some sort of early indication regarding the sales or the systems that is expected to be delivered this year. My question is mainly clarification follow-up. Just the first one relates to the nine-month period. Does that, just for clarification, include the sales processes, or is that from this sort of establishment of a firm interest to actual commitment?

Jonas Jarvius
CEO, Q-linea

Yeah. First of all, good afternoon, Johan. I would say that the way we look at it's maybe somewhere in between, but it's definitely included from that you have a customer that's become a prospect and decide, I want to validate the system. From that time on, I would calculate that. Some might be faster, some might be slower, but that would be the starting point from when I looking at the nine months as of today.

Johan Unnerus
Senior Life Science Analyst, Redeye

That's useful. It's probably a bit early on, a lot of things are, of course. At the time before then, that decision to evaluate the SR, how long is that process?

Jonas Jarvius
CEO, Q-linea

I mean, that could be fairly quick, I would say. I mean, we do see some of it's scientific. They of course have a number of people in the sales force throughout Europe. I think also, I mean, at ECCMID today, we well exceeded or met our criteria for leads. For a lead turning into a prospect, I mean, more likely that could be a fairly short process. That could be a couple of weeks to get. That's really the phase, again, in my opinion, where you have an interest overall and want to familiarize to the product. Of course, it doesn't have to be long before you say, "I would like to try this in my lab." I would say that in overall sense is could be considered as a shorter timeline.

Johan Unnerus
Senior Life Science Analyst, Redeye

Excellent. This actual evaluation process, how long is that out of these 29 months?

Jonas Jarvius
CEO, Q-linea

Right. Roughly, I mean, what we have seen is a 4-6-week time. You need to have the system sort of installed, and you need to have some training, although very quick. Really what we see so far, and of course some of this scientific, maybe needs to talk more of the details. I mean, I've talked now from our experience in Sweden. I don't think they are very different. Then the customer would like to run the system. I mean, and that's basically running it in their clinical setting. They run it with their samples, they try to incorporate in the workflow. Typically, you would need around sort of a in the order of 3-4 weeks for that.

Say 4-6 weeks from start to finish, meaning that you come with the instruments and you remove the instruments in a sense.

Johan Unnerus
Senior Life Science Analyst, Redeye

Excellent. We presume that some of the shortage or constraint here is actually to initiate this local evaluation process. It's not only the 4-6 weeks, it's about having the capacity to actually go ahead with all the evaluations.

Jonas Jarvius
CEO, Q-linea

Yes. Yes. You're exactly right, and that's also what we see. I mean, because to do these installs, I mean, these are the experts, the specialist application specialist, service engineers. Today we see that we have more customers wanting to do it than currently can be supported. I think it's, again, as I also mentioned a little bit in my presentation, is that it is fairly natural in the beginning. You have an idea of the number of resources needed, then you might have to adjust that or strategy to meet that demand. I think it's likely to see early on in the phase that you have to adjust sort of the number of people or the type of people that performs different tasks.

Of course, that's something we also look forward now to see that how can we improve on that? Because overall, I would say it's much better to have an interest of people wanting to do it than the other way around. Of course, equally, you have to sort out that issue and improve, I would say, yes.

Johan Unnerus
Senior Life Science Analyst, Redeye

The challenge during 2022 is to sort of secure that you have the collaborations with some officials, that you have the sufficient number of people to initiate the pilot evaluations. Then into 2023, perhaps you will have an increased number of labs that actually will be sufficient or enough with the shared experiences and reference labs and not necessarily.

Jonas Jarvius
CEO, Q-linea

Yeah, I would say so.

Johan Unnerus
Senior Life Science Analyst, Redeye

separate. Yeah.

Jonas Jarvius
CEO, Q-linea

No, I agree. I think that's well stated, Johan.

Johan Unnerus
Senior Life Science Analyst, Redeye

Yeah. Finally, also regarding not that we expect it to be specific, but at this very early stage, I guess there is no sort of typical or normal dynamic between system sales, machine sales and kits.

Jonas Jarvius
CEO, Q-linea

No, you're right. I mean, at this early stage, and also as I commented a little bit earlier on that, at this stage, you might have a different customer that, of course, all see the value of ASTar, but they can provide a different value for the next part of the sales cycle. It is too early to provide sort of an average pull-through on the instruments, and statistically it's just too early. Of course, that's something that we want to see coming forward when you can actually start doing these averages and you can start cluster and classify the various type of hospitals or lab that do run ASTar.

Johan Unnerus
Senior Life Science Analyst, Redeye

Perhaps when you feel that you are ready to give some sort of guidance on the kits and system separately, that's also an indication that you sort of start to see a more normal dynamic.

Jonas Jarvius
CEO, Q-linea

Yes, that could be one way to trace it for sure. Then we just have to decide when we think is the right time to do so. Yes, I still think you need to, in this phase, really look at getting the full picture and starting to classify each individual sort of customer before you do an average analysis.

Johan Unnerus
Senior Life Science Analyst, Redeye

Okay. That's all for me. Let's hope for a short spring then.

Jonas Jarvius
CEO, Q-linea

Thank you very much, Johan.

Operator

There are no further questions at this time. I hand back to you, speakers.

Jonas Jarvius
CEO, Q-linea

Okay. Thank you very much for all the good questions and everyone else listening in. Me and others would like to say thank you for our presentation of the first quarter 2022. Of course, we do look forward to come back in the next quarter and also present what has happened over the next three months. Thank you from me.

Anders Lundin
CFO, Q-linea

Thank you.

Jonas Jarvius
CEO, Q-linea

Have a nice rest of the day.

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