Q linea AB

STO:QLINEA

Earnings Call Transcript 2021-Q1

[Operator]

Ladies and gentlemen, welcome to the Q-linea Q1 Report 2021. [Operator Instructions]. And afterwards, there will be a question-and-answer session. Today, I am pleased to present CEO, Jonas Jarvius; and CFO, Anders Lundin. Speakers, please begin.

[Jonas Jarvius, CEO & President]

Thank you very much for that presentation, and welcome, everyone, to the report for the first quarter of 2021. We had an amazing quarter. And I must just say that the whole team at Q-linea should really be proud of our accomplishments, and I'll go through a number of them, of course, in the presentation. If we move to next slide, we have our disclaimer in case me and Anders will make any forward-looking statements. We move on to Slide #3, which is a brief overview of Q-linea and the main activities for the first quarter. Our goal at Q-linea is really to develop disruptive solutions for faster infectious disease diagnostics. The first product is targeting blood stream infections, or sepsis, being the most predominant application for that. We have grown over the quarter according to plan with around 146 employees and consultants. And we had, as I mentioned in the start, an amazingly strong quarter. First of all, we could provide very positive interim results for our European clinical study for ASTar focusing on sepsis. We also received the first commercial order from Thermo Fisher Scientific, valued over SEK 8 million. And of course, we achieved this before the CE mark, which I think indicates the commitment and the trust in the product. However, right now is, of course, in premarket activities, moving, of course, now into market activities from the announcement we had earlier this week, and I will comment on that later in the presentation. So we're really finalizing all materials to get ready to enter the commercial phase. We had also some really positive developing of our next-generation development product, which is our portable culturing technology, I will not talk so much about that during this call, but please follow us and follow the development of that product as such. If we then move to the next slide, as I mentioned, sepsis is our first priority. Sepsis is a global health crisis. It's the most common cause of death at our hospitals, and a person worldwide will die every third second from sepsis. What you really need to do when you have a patient entering sepsis, perhaps progressing to septic shock, is to treat the underlying infection, because sepsis is caused by an infection you have somewhere in the body. You might have a skin root, you might have pneumonia. Bacteria will then leak into the bloodstream, and for reasons that are not typically fully understood, our own immune system can then dramatically overreact to these bacteria in the bloodstream and start attacking your own body and shutting down organ after organ and could lead to severe follow-up conditions or death. It's also very expensive to treat patient with sepsis, because when you progress into septic shock, you, of course, also move into the intensive care unit. You have a staff of physicians and health care staff helping you to survive and combat that infection. And as we have seen over the last year, and we are still in this big corona pandemic, we also know that intensive care beds are expensive, and we have too few of them. So this is a big, big problem. If we then move to the next slide. When we look at sepsis as such, I mentioned the leading cause of death. When we look at Europe and U.S., around 0.5 million people will die every year. But really, why we need improved diagnostic method is that, when you diagnose a person with sepsis, you start empiric therapy. Meaning you as a physician will do your best estimate on how to fight this particular infection. But in around 50% of the cases, since you are lacking diagnostics at that occasion, the patient actually received inappropriate treatment. And even worse, in around 20% of the cases, the patients will have died before you get the correct diagnosis on what antibiotics or antimicrobials should be used to treat that patient. And this is really where ASTar comes in, making a dramatic improvement, reducing time to really tailor the treatment. So the most narrow antibiotics for that particular patient detections. I'll come back to some of the high economic benefits that has been shown with more rapid diagnostics. But apart from sepsis, the first application, we have perhaps an even bigger problem that we as a society need to fight, and that's antimicrobial resistance. As you know, bacteria has become more and more resistant to the line of drugs we have to treat infections, and this is partly due to abuse of antibiotics, both in humans but also in agricultural use. It has been presented to the -- as the biggest threat to mankind. And there are some really, really disturbing numbers here that we need to tackle. But of course, if we have rapid diagnostics and can have evidence-based prescription of antibiotics, we can really reduce unnecessary prescription and use of antibiotics, and that will, of course, help reduce antimicrobial resistance. But if we look at the problem as such, in 2016, around 700,000 people died from untreatable infections, and it has been indicated that if we don't change the way we treat the change diagnostics, in 30 years, that number will go to 10 million people. This is mind-boggling numbers and it's very important to start to act now. And we also see that ASTar could be one piece of that puzzle in help fighting antimicrobial resistance. If we then move on to Slide #6. This is an overview of the current traditional diagnostic flow for septic patients. You can see that on the gray upper panel. I will not go through the steps today during this call, but you can see that it's a multi-day multistep process. And what you are aiming for is you start treatment day 1, of course. And then you can see the green circle in this case, indicated day 4, can sometimes also be day 3. That's when you have the diagnostic answer on how you should treat infection. And as I mentioned earlier in the call, around 20% will actually have died before you receive the results today. But if you look at the lower part, this is where ASTar can make a dramatic improvement. For 2 reasons: first of all, you see that you have a lot fewer steps that needed to be performed by the lab staff. And today, when we are, for instance, in a pandemic, you know that we have a very high workload on the staff in the microbiology labs. So of course, if you can reduce that and make it easier to start analysis, that's a very, very important criteria. Secondly, and of course, perhaps more importantly is that you can find the right treatment therapy much, much faster, and time is really what counts for septic patients. So if we look at ASTar overall, we have really designed it to run 4 pillars. And we have design, it's in very close relationship to hospitals, Europe and U.S., to really understand what's their need, what's the most pressing point, what needs to be addressed in a fully automated system for infectious diagnostics. While it needs to be easy to use, we have decided ASTar to be fully automated. It has very low hands-on time, and we have a random access workflow. And this means, of course, that you can utilize the lab staff in a very efficient manner. You can also run the analysis at any given time point, since you don't need to have highly trained personnel to the start test. And since we have random access, it means that at any given time point our ASTar has free capacity, you can start to run, all very important factors. Secondly, of course, it needs to be fast. We present results from bottle blood cultures within around 6 hours. We have a high throughput with around 12 patient samples in parallel in the system at maximum capacity. But of course, it also needs to be comprehensive. You need to have a large coverage, both in antibiotics or antimicrobials, but also the concentration ranges, so you know if you have a wild-type bacteria or very resistant bacteria, and we have really designed and had a goal to have a very comprehensive panels. And also, you should cover the various types of bacteria you find in infections. And we have also design our sample support, fastidious and non-fastidious bacteria, but also, we have built the system for future. So it has already been built to handle other sample types such as isolates, but also other subtypes such as urine. And we really see that is to be a strong and interesting development of ASTar going forward. And of course, the last point, you need to have accurate results. ASTar delivers true MIC values at a very high reproduce-ability, and the MIC value, that's the concentration that kill or inhibit growth of bacteria. So that's the highest precision you can provide in acceptability test. If we then look at Slide #8. This is one very, very important part. This is a testimonial from Eshan Ghaderi at Uppsala University Hospital, who tested the system, of course, during last year and participated in the clinical study. And it's really supposed to be simple to use. It's put the barcode on from the patient, add the sample. You then approach ASTar. And you have a graphical user interface that will guide you through the rest of the process of loading and starting the sample. And as I mentioned, it could all be done within around 2 minutes. And in this case, of course, the staff can then continue to do other important tasks at the microbiology lab. If we then move to Slide #9, here, we can see 3 independent health economic studies that have really looked at the effects of providing 24 hours faster diagnostics compared to the current workflow. I think the number that strikes to me the most is the reduction in mortality. So providing the right treatment for this patient group can dramatically then increase surviving rate of these patients. Secondly, in the middle, of course, if you can move from this initial broad-spectrum therapy, so in our spectrum, targeted therapy faster, not only you provide less side effects for the patient, of course, but you can also reduce the pressure for superinfections, opportunistic infections at the hospital. And this is, of course, very important for antimicrobial resistance. Thirdly, one report indicated that, if you can do it 24 hours faster, you could on average save 2 hours in the intensive care and 2 days in intensive care bed. And of course, these are very expensive beds. So if you can get the patient out of these expensive beds on average 2 days faster, not only do you increase the capacity of those beds, you also save a lot of money. And as I mentioned, ASTar can provide around 24 to 48 hours faster diagnostics. So we think this is a very important part. And of course, we are now planning to enter our own health economic study, outcome studies to look into this. If we then take the next slide, we will actually move into the highlights for the first quarter. As we did present was very strong interim results from the CE-IVD study. They were all well above the required guidelines for approval here in Europe. We had an overall essential agreement above 94% and category agreement over 97%. And essential agreement, as you see that we said -- would give the same concentration by kill or inhibit bacteria as a reference method, and categorically remain with respect to provide the same treatment recommendation today divided in S, I and R categories. We also had a very high reproducibility of the system. So what we then, of course, continued during the quarter was to finalize the paperwork, the technical file and some validation activities to apply for CE-IVD registration. And as you saw, after the clearing them, we could do so very successfully. But apart from running the study in Europe, we're of course, also planning to enter the U.S., and we could also sign the first party to participate in the U.S. study. If we then move to Slide #11. Other important highlight was, of course, that we received the first order of ASTar. The value was over SEK 8 million, and we can also disclose some of the structure with binding period and part of prepayment. But of course, another very important aspect has been to work together with Thermo Fisher Scientific, our real worldwide partner in the launch of ASTar to finalize message, material and so on. And that has been very successful, and I'm really happy and excited to work with Thermo Fisher. It's a great team, and I think both sides have tackled working electronically very well during the pandemic. But apart from material, of course, training is important. So we are now escalating activities to train both sales and service personnel. And again, I think both teams have done a great job in accomplishing this on 2 sides of the water, so to speak. If we then move into Slide #12. This is really an important key highlight after the period end, and we could send the press release earlier this week that we have now achieved CE-IVD ASTar, with actually even a bit stronger results than our interim results. So the essential agreement was 94.7%; the categorical agreement was 97.6%, and overall reproducibility was 99.6%. And what I'm particularly proud of is that when you look at the ASTar instrument and ASTar gram-negative kit, it truly offer the broadest combination of antimicrobials and dilution ranges in a single analysis for gram-negative bacteria of all system that we can see are on the market today, and we also deliver true MIC results. So again, very proud to do this. We are, of course, not happy. We're not sitting still. We will continue to make the panel even better and of course, now take the next step with additional tests to ASTar. If we then move to Slide #13, we are, of course, now running full speed ahead with commercial activities. It says pre-marketing on the slide, and we ought to have the CE-mark. So it's now moving from pre-marketing to marketing, of course. We are still continuing to train personnel, final preparation and marketing material. And of course, I am a strong believer that a long-term success of a product such as ASTar, which has a huge unmet need and a wide variety of markets, is to first do a controlled evaluation and make sure that all the early potential problems are solved, and do that with key customers and then enter in the next stage of a sort of a fully fledged launch. And of course, that's what I had from my side. I will now continue to move to Slide #14, and talk about the effects of the corona pandemic. As you all know, we are not through the pandemic yet. We can perhaps see the world coming a little bit brighter. We see vaccination ongoing. And actually, for the first time, we have seen some slight effects of the corona pandemic on the company operations. We've seen a slight increase in sick absence, but also, I would say, positively, most of these cases has come -- has been affected outside the company and not within the company. And we do all our -- what's in our efforts to have the people that needs to be on-site to work safely, and of course, have many people work-from-home. So we have seen no major changes in time line due to the pandemic, but of course, this can always change. So of course, what we can see, what might happen, although I would say that last year, I think we pressed on extremely strong through the pandemic, but of course, we can see delays in upcoming studies, for instance, U.S. study. It could affect commercial activities. It could increase expense levels depending on all of the above. So these are risk factors that I don't think anyone can sort of avoid. But we'll follow it -- the development carefully. And I think we have done a great job so far of tackling the effects of the pandemic, and I do hope that we will see a world coming into a more open environment, more open society coming into autumn. So that was the last slide from my part of the presentation. I will now hand over to Anders Lundin, our CFO, to discuss the financials for the first quarter.

[Anders Lundin, Chief Financial Officer]

Thank you, Jonas. So I will summarize the financial reported in the Q1 report in 3 slides. So I will start off with Slide 15, which is the numbers from the income statement for the first quarter. And as you can see, we did not report any net sales in this quarter. The operating results was close to minus SEK 64 million compared to close to SEK 56 million last year first quarter, and that is mainly driven by increased personnel costs. We are -- we have been recruiting for the full -- the last year quite heavily, and the average number of people during this first quarter were higher than last year. We reported a loss after tax of SEK 63.2 million and earnings per share before and after dilution were amounted on SEK 2.34 minus. So if I switch over to Slide 16, most important lines. And our balance sheet is cash equivalents, SEK 12.5 million compared to SEK 10.1 million, which was by the end of the year last year. So it's a comparison by end of 2020. And we have since last year's slight issue. We have surplus liquidity, and we have placed that in short-term investments, that's interest funds mainly, and we have listed bonds. We have a short to noncurrent part of the bonds, and we have short-term bonds that are due within 12 months. So the short-term investments was SEK 106 million, and current portion of the noncurrent asset was SEK 83 million -- close to SEK 83 million. And then we have long-term bonds of SEK 73 million. And we have also been working on the launch inventory, and that is now SEK 16.3 million all in all. And the majority of that is finished goods. There are of course some raw material and working -- work-in-progress, but the main part is finished goods, ready to support our coming launch here. And then if I switch over to Slide 17, that is the cash flow statement for the first quarter. We had cash flow from operating activities. It was minus SEK 56 million compared to minus SEK 59 million. And we had the difference here. We had lower operating result than last year, but we had an offset by improvement in the working capital compared to last year. If we go to investing activities, we have SEK 58.5 million compared to SEK 61.6 million. The majority of here, we were reorganizing our bond portfolio to -- we sold bonds with short terms and bought bonds with longer terms. So that will basically shift -- those transactions gave a shift in those 2 lines. And financing activities was minus 0.1. So just amortization of some loans we have. So if we summarize the cash equivalent, short-term investment and the bonds are amounting all in all to close to SEK 275 million and compared to the SEK 331 million we have by the year-end. So the Board assessment of this balance that it will cover at least -- running the company for at least next 12 months. So that -- with that slide and those words, I summarize my -- the financial reporting.

[Jonas Jarvius, CEO & President]

So thank you very much, Anders, for that, and we are now opening for questions.

[Operator]

[Operator Instructions] Our first question comes from the line of Ulrik Trattner of Carnegie.

[Ulrik Trattner, Research Analyst]

And first of all, congratulations on the CE approval of ASTar. I have a few questions, if I may. And then if we can start off with the technical filing of ASTar and just in your words, how important is the wide antibiotic panel and the inclusion of fastidious pathogens, especially since this, according to my knowledge, at least, is the first fully automated AST system, including fastidious pathogens? Just your take on that would be my first question.

[Jonas Jarvius, CEO & President]

Okay. First of all, thank you, Ulrik, for the congrats. We are really happy from our side as well. To come back to your question, what I think is important to have a broad coverage overall is, of course, if you want to act upon a rapid result, you need to have a good coverage. You don't ideally want to wait for too many follow-up traditional results to act and change upon that. So as you said, when we look at the market today, if you do the combination of antibiotics, dilution ranges, we clearly see that we have the broadest panel in our opinion, but of course, we are not a company sitting still. We are still moving on to expand the panel even further. We have programs already initiated for that. And I think that -- I mean the true goal is to be able for physicians to be able to treat patients effectively no matter if it's an ICU patient or an ER patient. So I think it's very important. I also on the comment on fastidious pathogens, they are not extremely common for gram negatives, but it's an important group. In many cases, when you have a fastidious infections, first of all, you can have a very rapid escalation of the progression of sepsis. So I think it's important, but I think it's also important from another standpoint that we have really now been able to show that our commitment from day 1 to include as much as possible from various pathogens to various antimicrobials, seems that we are on a very good path with the system. And I must again say, really thank you to the entire team at Q-linea that has worked really full speed ahead of doing that with a great commitment. I mean you can't do this without a great team. So that really goes out to everyone in the company.

[Ulrik Trattner, Research Analyst]

And just on the same note, what has been the feedback so far? We know that you've been out talking to hospitals in the Nordics. How important do they believe that this wide antibiotic panel is, because it's obvious that this will be regional differences in terms of what type of antibiotic is used as well as resistance suggest how important do they say that this wide antibiotic panel is in comparison to what they have been currently using?

[Jonas Jarvius, CEO & President]

No. I think that, first of all, some of them are little used to it. I mean when we look, for instance, at academic hospital, we could provide answers on 10 more antimicrobials. So of course, it gives you now much more of a wealth of treatment options to have more coverage. So I would say that we have very, very strong feedback from the customer on that. But also, I would mention that the ease of use of the system that anyone can run it, and it's really little hands-on time, I would say that these 2 in combination is really what provides a good value proposition in my opinion for ASTar. But -- and also, as you correctly mentioned, I mean, having a broad panel means also for us as a company that we can have a panel that could work in the southern part of Europe as well in the Nordics without having to have different panels to choose from. And I think that's also very, very much important. So I would say that we get very positive feedback overall from the various parts. But I think also it comes a little bit that when we started developing the product, we really started developing together with our future customers and put their feedback and filter that into the system really from day 1. So I think that -- in that sense, we're really trying to meet the goals of the customers in an ever-changing world with even more resistant bacteria coming up. So It's clearly been important for sure.

[Ulrik Trattner, Research Analyst]

That's great. And you emphasized a controlled launch phase. Could you just please shed some more light on what that actually means and how long that would initially take as well as you've already received your first commercial order from Thermo Fisher. Is it reasonable to assume that the full order of this SEK 8 million could be installed already during Q2? Or is that too ambitious?

[Jonas Jarvius, CEO & President]

Yes. So first of all, of course, as you know, we and Thermo Fisher are different companies. They will, of course, plan their large activities, and we do as well. Of course, we talk about it together. And it's really my opinion. One -- I mean, I've been working in this field for some time. And I think that we have always planned the company to be a long-term, truly successful company. And I think that the best way to do that is, as I say, we do a controlled phase where we test the system in a little bit smaller group wider than we have done so far, obviously, and really understand that are there anything we need to address with the system before we go, so is that -- full speed ahead. But also, of course, get the opinion on good key opinion leaders with their thoughts on the system. And really, the phase of doing that, I would say, enables us and Thermo Fisher to really be confident in really pressing on in sort of a Phase II. The time line for that is, of course, as fast as possible, but that's not the answer you want. And like from my judgment, my estimation, I would say that what we're looking here is months and definitely not 6 month or years. I mean we're talking of a shorter time on perspective as we have, of course, also tested ASTar outside earlier. But I think it's important to really see -- and it's not just ASTar, it's also, of course, we as a company, Thermo Fisher as a company to also work as a smooth operation and be ready to take the system for the next level. So I think that's the way to pay for long-term success. To comment on the first order and the number of systems that could be installed, I would rather not comment on that, Ulrik. I know you would like to have an answer. But what I can assure you is that both we and Thermo Fisher Scientific are really eager to get this product out to the market, of course, as fast as possible, and after having the first control phase really as efficient as possible. So we will not rest here. But it's very hard to give an exact time line. So I rather not do that.

[Ulrik Trattner, Research Analyst]

Fair enough. Fair enough. I think I got most of it. The line is sort of breaking up. Just move on to -- perhaps give some clarification on the U.S. study? And what is left in order for you to initiate that study as well as you have already contracted your first site, is the ambition to include additional sites? And when are we to expect that to be concluded? That would be my next question.

[Jonas Jarvius, CEO & President]

Yes, right. So of course, when we signed the first site that was important, that was really one of the key to get the study started. As you know, FDA has allowed us to perform a big part of the study here in Europe. So the next phase is really for us as a company to ramp up activities and start the U.S. study. We are also, of course, talking to very good, very renowned hospitals to participate in the study. But they -- we don't need to have them contracted really to start the study since we can actually do that internally and sort of mirror the strategy we had for the European study. So of course, we will announce those sites as soon as we have put the pen to the paper. But we don't actually have to wait for that to start the study. So we are definitely moving way, way closer to how study start, also for the U.S.

[Ulrik Trattner, Research Analyst]

And would you call -- there's a time line would be quite similar to that of the European study? Or is it any sort of major difference as before you can actually file for a 510(k) approval?

[Jonas Jarvius, CEO & President]

I would say that overall it's quite similar to the European study in overall scope. We have a little bit more analytical study requirements for the U.S. study looking at interferences and so on. And it's, in a sense, a little bit larger study to coordinate. Time line would look, I would say, similar for sure. Maybe it's a little bit longer in the U.S. And of course, we ought need to follow how the corona pandemic sort of settles, which I do hope it does. So it makes it easier to travel for us also to the U.S. But no major changes, I would say, yet.

[Ulrik Trattner, Research Analyst]

Great. Two last questions. You mentioned and highlighted in the report that you're ready to initiate a pivotal trial for your culture transportable culture cabinet. What -- when should we get some more clarification on the scope of the study in terms of number of samples that needs to be included and time lines?

[Jonas Jarvius, CEO & President]

Yes, right. So I mean, we had a very, very strong development of the portable culture technology during the first quarter. And we really sort of upped our time line a little bit. And as we said in the Q1 report is that we really plan to have the study going on already next year. I think coming back with some more granularity on the time line of that, is something to expect. I would not say necessarily during Q2, but we will share some more of the very strong data we have on that. But I think we'll come back during -- after the summer with some more details on the time line. But I must say that I'm impressed really with the development efforts we have made and the progress we made on that technology. And also the initial feedback we have received. So I'm really glad to see, of course, ASTar now coming to CE Mark, but also already now be able to start detailed planning for really a next product with a very interesting opportunity coming up. So I think you will see continuously more information of that coming up over the next 6-month or so, both on the product development efforts and also in study preparations. There will be no exact time line for that. But I'm sure we will continue to add more of that. And also, we actually wanted really to focus on ASTar now, which we have been doing, but that's not everything we do in the company. Again, I said, we plan long term. And I think that being able to present this technology that can really start shaving off time is something I'm truly proud of as well ASTar.

[Ulrik Trattner, Research Analyst]

Great. So looking forward to get some more information perhaps in the fall for the culture and cabinet. So just the last question, and this might be addressed to you, Anders. What you said, and I'm not sure if I interpreted that correctly, but you have a little bit more than $270 million in cash and equivalents currently on your balance sheet. And you said that, that would be sufficient to finance operations over the next 12 months. But does that entail that there will be a significant cost ramp up? Or should we interpret it as the current balance sheet actually financing the company well beyond the next 12 months?

[Anders Lundin, Chief Financial Officer]

No. We said 12 months, that is the requirement that we have to say if we are below or over 12-month financing situation. So that will -- the $274 million will take us at least 12 months forward. That's for sure.

[Ulrik Trattner, Research Analyst]

Yes. That I understand. And once again, congratulations on the approval in Europe.

[Operator]

And our next question comes from the line of Jonas Amnesten of Redeye.

[Jonas Amnesten, Equity Analyst]

Congratulations to a good quarter of 2021. It looks like it could continue. My first question will be regarding the stage launch, and during this first period, 2 to 4, 2 to 5 months, as you alluded to, which is your prime area, which is ICU, ER, is it possible to say anything on type of patients to sort of early-stage, sepsis patients? Or is this something that you're not prepared to share at this stage?

[Jonas Jarvius, CEO & President]

Okay. Thank you very much for the question. I would say that, first of all, the initial phase, as we said, I don't think we really plan to segment patients. I mean as soon as you have a possible blood culture, ASTar can truly analyze that. For sure, it's interesting to see the effects on ICU versus ER patients. But I think the product itself could be used for both early and, of course, late-stage patients. So it's a little bit too early to provide that information. And I think also I must announce that for the major part, of course, Thermo Fisher Scientific will be responsible for that part. And I can't really comment on that strategy from Q-linea's behalf. But I don't say you have to segment a certain group. I think we'll look quite broad for this type of evaluation.

[Jonas Amnesten, Equity Analyst]

And regarding the U.S. study and the requirement, is that the -- FDA, MIC, ISO in the previous similar in this for your candidate ASTar. Is there any reason to believe or expect that there could be any difference in the patient cohort? Or in this total standard of care that there could be any reason for that sort of difference in the outcome as the precision is very high in Europe?

[Jonas Jarvius, CEO & President]

Right. Thank you for that. I would say probably, I'd pick my chin out a little bit and say, no. The precision reproducibility is more or less built into the system. I do expect, of course, that we'll see much more 24/7 use of the system since that is more predominantly used in the U.S. And of course, a study is always uncertain until you have done the study and completed the registration, but as I also mentioned, we think we have an excellent panel, but we will continue, of course, to work to improve that panel. I think that will also come to benefit to the U.S. So on a high level, I really don't see that we were to expect some different type of results from the U.S. study, at least not with my knowledge right now. I would say it should look quite similar to Europe.

[Jonas Amnesten, Equity Analyst]

That's useful. And regarding the price in the model, is it possible to shed some light on the split on consumable and system? And also is this service contracts in build? It seems to be like a special machine that have almost, maybe there's not so much service to be done and -- but there is obviously an education training depiction that we're beginning and perhaps recurring to some scale to some degree?

[Jonas Jarvius, CEO & President]

Right. Yes. So the pricing, of course, is something that will be obvious quite soon, but I can't disclose that today really on the instrument system. I mean in general, of course, it's always overall long-term success means that you have a good revenue on the consumables, that's for sure. I think also, although ASTar is extremely, it's used from an operator standpoint, which is what we have been working really hard on, I think that you should -- you should expect that will be some teething problems initially, some software balance that needs to be fixed, that needs to operated I think that happens to every new system being launched. I have not at least seen any that really have passed on. But I think also we are equipped to do that, and really build in and serve on the robustness of the system. So I think that's commitment what we and Thermo Fisher have, and I can't see anything there that's put me to be nervous. Of course, we have also been running ASTar quite a lot now, and it's a very strong performer, I would say, overall as a complete package. So I think that when you come forward in future quarterly reports, I think also some more of the financial terms will become more obvious. And also, when we start sharing bit more of the marketing materials, of course, the CE Mark is very fresh now. We will be able to disclose a little bit more about that type of pricing. Looking at service for these type of instruments, what you typically see, at least what I'm used to is that you see a service contract where you might have bronze, silver, gold type strategies. And it all depends on how fast you need to have service, how important is it to be serviced on the spot. And of course, we are looking into that from our side. And of course, Thermo Fisher is doing that on their side as well. But I can't give you any detail, but on an average level, that is what you would might expect from a similar type system.

[Jonas Amnesten, Equity Analyst]

It seems like the first stage seem to be rather short. Are you confident that you'll be ready for volume delivery in 2 to 4 months?

[Jonas Jarvius, CEO & President]

Well, I mean, if you look at everything else, I think we are ramping up to be able to support the plans we have together with Thermo Fisher. So of course, we plan our production capacity and volume according to the long-term plans we have together. And I'm really confident that we can support any type of scenario that's coming up with us. We've also chosen a good partner in Sanmina for instrument manufacturing. We know that they are worldwide company with a good reputation that are also ready to handle volume. And I think also, as Anders mentioned, we have also actually been building some loan stock to be sort of be ready to handle those situations. So I personally feel very confident in the team to deliver according to expectations for sure.

[Jonas Amnesten, Equity Analyst]

And finally, you mentioned that we will have sort of reach and handpicked approach to this stage. And you also mentioned that you have collaborated in and your development base in several institutions or hospitals, how earlier presumably, you have a specific pipeline with these centers that we are likely to engage now after the first phase.

[Jonas Jarvius, CEO & President]

No. Of course, I mean, you're correct. We have been working with a number of customers for a long period of time. We have at Q-linea has been doing premarket activities, sensing the interest of the product sort of so to speak for the Swedish market. Of course, as you know, we have a very good partner with Thermo Fisher Scientific, and I'm not really at liberty to describe their pipeline, their funnel, as you understand. But you're right, of course. When you do a launch, I think it's always better if you can, in a sense, handpick customers to really make sure that you get the most out of the first phase before you go broader. So I think that's a good, sound strategy for any company to go on. And I can't give any more details, but I'm sure we will be able to announce more of this as we come in now in the commercial phase.

[Operator]

We currently have one further question in the queue. [Operator Instructions] And our next question comes from the line of Adam Karlsson of ABG Sundal Collier.

[Adam Karlsson, Research Analyst]

Just a couple from me, if I could. You spoke about the whole health economic potential demand. I'm just curious to hear whether you're getting a -- you've got any sense from potential future customers that you're talking to, whether they are very much looking towards your health economic studies, is it the internal one that you're preparing, whether that's something that they're kind of holding out on potentially, that they want to see those study results? Or whether they're happy to kind of overlook that for the time being. And then whether that's something that will just be a complement going forward?

[Jonas Jarvius, CEO & President]

Right. So first of all, thank you for the question. I think it's a good question. I would say, yes and no to that. I would say that from our experience, what we have seen talking to customers is that there is such a big need for these type of systems. So to think there are 2 types of customers. One part are really eager to get going. They see the big unmet need, the improvement that could be made. I don't think they will wait, for sure. I don't have any indication of that. I think when you then look in a very broad perspective, I mean, again, we're talking about a long-term commercialization of this product overall, I think there are some that will look into health economics to understand it better, and I think also to understand that at their particular hospitals because hospitals differs and they have different needs. And of course, very importantly, we are planning and have done for some time, our own health economic studies based on ASTar. We need, of course, to wait for the CE Mark. But this is again something that I would be happy to announce a little bit more when we come into that. So I can't see that hindering the launch for now. I have not heard anything like that. But I think long term, it is very important to show health economic data supporting the product as such. So I think the question is, I don't think we'll see a hesitation for the first sort of round of customers. That's not what I've seen.

[Adam Karlsson, Research Analyst]

Okay. And in terms of that internal health economic study, do you have a rough idea of kind of the time line for that, when that might be coming about, when we might be hearing about a start or the fall season?

[Jonas Jarvius, CEO & President]

Yes. Yes. We have a very precise time line internally. And of course, I'm expecting you to be able to hear some news on that study fairly soon, disclosing more of the study as such. Then when you look at the health economic study and typically, I would say that you can estimate that to run for a year or so, depending on, of course, what are the variables, what are you looking for. But of course, also depending on how you plan it, you can really also anticipate to see some interim results coming up beforehand to really see that we are tracking in the right direction. So on a high level, I would say that it will not be in a too distant future that we'll hear more about our internal study. And then if everything goes well, of course, hopefully, we'll be able to provide some more data on that during the second half of the year and coming into 2022. But this is an important aspect for us internally. We have a very, very good Chief Medical Officer. And I think that -- we take this very seriously. We have not only excellent microbiologists, but also clinicians because it's very important to understand the 2 sort of main stakeholders in treating these patients. You have the physician and their needs for faster diagnostic, what do they need. And then you have the microbiology to deliver those results in an efficient way, and of course, in a very productive comprehensive way. So I think we try to look at both these sort of side of the coin. It's still the same coin, but they have different opinions what's needed. And I think that's something we've done a very good job at in the company so far and of course, plan to continue to do.

[Adam Karlsson, Research Analyst]

Okay. Great. And a question on the U.S. study and regulatory process. Just whether you have gotten any feedback or any sense from the FDA that they might be -- might have longer processing time, handling times on account for the pandemic and backlogs associated with this about anything that you've heard or -- gotten any feedback about that?

[Jonas Jarvius, CEO & President]

Well, so, typically FDA in my opinion does not provide such guidelines to individual companies. I mean what you have seen -- what we have seen over the last year is that we have seen longer times for clearance. We saw last year we had a tremendous amount of test for primarily PCR tests for SARS-CoV-2, that current variant of the buyers. And of course, that expand. We see a lot of vaccine trials. So I think in a sense that we are now moving into a more steady phase in the FDA approval process or not approval but clearance process. I think it's also worthwhile mentioning that when you look at the FDA's top priorities, sepsis and infectious diseases is really one of their top area to focus on. So I think that -- I mean, as you look at it, it's the #1 cost driver in the U.S. for septic patients. We see a lot of suffering and a lot of people dying for it. So I think it's high on the agenda. I think we have had a very good response from FDA where we have had questions for the study design and so on. They have been very responsive, I would say, in that aspect. So -- but we have no clear guidelines. But I think it's safe to say that at least so far, they had a little bit longer period to do analysis because they had so much to do. And I truly hopefully see that this will actually go down when we come into the autumn, as we -- I mean at least most of the direction we see on pandemic is that with increased vaccination, we are now better suited to test. I truly hope that we will see a better scenario coming forward. So I think it's a little bit higher on the risk, but it's really too early to give something exact at this point.

[Operator]

And as there are no further questions at this time, I'll hand back to our speakers for the closing comments.

[Jonas Jarvius, CEO & President]

Okay. Thank you very much for that. And thanks for all the questions. And I -- we just closed this Q1 report, we're saying that we are now truly looking forward taking the product out to the commercialization phase. And again, I must say to all the Q-linea team that, listen, it's the best team to have to bring a product out. And really look forward to the next phase of the company development. And with that, I will conclude the session from me and Anders, and hopefully, talk to you again.