First of all, welcome to our presentation today, where we're going to announce our achievements and financial position during the third quarter. Before we go into the presentation, I would like to call up the next slide, which shows our disclaimer in case me or Anders will make any forward-looking statements. With that, I will present the next slide, which is really the third quarter at a very high level. Of course, we'll provide more details during the rest of the presentation. As you know, at Q-linea, we are developing innovative and disruptive solutions for faster and better infectious disease diagnostics. The first product started being sepsis, ASTar has really been as a platform to support many other applications to follow blood cultures.
If I'm going to highlight one thing in particular during the third quarter, I would say that it's really the excellent feedback received for clinical use of ASTar at Uppsala University Hospital. It really indicates that all work we have performed during the last couple of years have paid out. Of course, another very important step is all the work done in preparation for the upcoming clinical study of ASTar. I must really say that I'm truly proud of the team at Q-linea. With the dedication and motivation and all the hard work that has been put in on taking ASTar into the first clinical studies. If you look at the company in general, we have grown according to plan and are now 134 employees and consultants at quarter end.
I will also come back a little bit at the end of this presentation, but I would like to announce an upcoming webinar next week. Please go in and sign up on our website if you want to have the latest news on ASTar and perhaps some other interesting activities. With that, I would like to go to the next slide. Here I would say, as we mentioned, sepsis is our first product. It's truly a global health crisis. It affects 50 million people annually throughout the world, and every third second a person will die from sepsis. It's the number one cost driver in the U.S. healthcare system, and if we look at Europe and U.S. alone, more than 0.5 million people die every year.
We have seen from early health economic research data that you could save a dramatic amount of lives with faster diagnostics. Time here is of essence. If you're on the wrong treatment when you're entering septic shock, the likelihood of mortality increases close to 8% every hour. This is, of course, the area where ASTar would like to present a dramatic improvement. If you look at the next slide, here you can see on the top part of the image the traditional workflow for sepsis diagnostics today in practice. Without going into detail, you can see that every gray circle corresponds to a manual step or analysis of the sample in the diagnostic workflow.
It's a multi-day, multi-step process, and of course, the answer you would like to have is the green circle today indicated at Day four, and that is when you can first really know what antibiotic or antimicrobial is going to treat that patient's particular infection. If you look at the bottom graph, of course, not only do ASTar reduce dramatically the number of manual steps needed to be performed on the sample, it also produces the results much faster. Up to 40 hours faster with very little user intervention on the system. I think it's important to remember that time to actionable results is really what matters, and I'll come back to that a little bit on the following slide.
If we take the next slide, we can see really the four pillars that ASTar has been built upon, and this has been done in close collaboration with a number of hospitals in various settings throughout the world. I would say that one absolute key is the ease of use of the system. Our driver has always been that anyone in lab should be able to start analysis at any given time point. Of course, it needs to be fully automated. We also need to have a very short hands-on time. It's less than one minute on ASTar. We've also built it according to a random access workflow, meaning that if you have free capacity in the system, you can load a sample at any given time point. Of course, it needs to be fast.
We provide the results in three to six hours, and we do that at a very high throughput. These are, of course, important factors, but if you are going to have actionable results, it needs to be also comprehensive. We can provide a very large antibiotic or antimicrobial panel at very long concentration ranges. We have tested the systems on the various categories of bacteria that you can find in septic patients, but of course, all the other infections. ASTar is designed as a platform. We have already illustrated and shown data on urine or, for instance, isolates. We see that there are many possible add-ons to come in the future of the system. That's of course good if it's comprehensive. Any result also needs to be accurate.
What we're seeing today in the ever-escalating increase in the antimicrobial resistance, we're seeing the value of true MIC results. MIC stands for the minimum inhibitory concentration, meaning the concentration that kills or inhibits bacteria. That's the highest precision you can deliver in a susceptibility test. That, of course, needs to be reproducible. I will look at these two things a little bit more in detail. If we take the next slide. This is an example, and I will walk you through it. What you see on this graph on the Y-axis is the probability of target attainment during a treatment regime. On the X-axis, you can see various MIC concentrations. I mean the concentration that would kill or inhibit bacteria. You have five different graphs, all coupled to different treatment regimes.
For instance, the concentration of sample, the time for infusion, and intervals in between infusions. What is quite clear is that when you have low MIC values, you can see that almost all these treatment regimes are equally as effective. You want to be very close to one here. It's also quite clear that if you have a high MIC value of this particular bacteria, we can see that it's only the orange line that will provide effective treatment, meaning 1 g every eight hours during a three-hour infusion. Unless you actually have the MIC value, the likelihood of treating this particular patient to be wrong is quite high. The value of MIC, I would say, becomes more and more important when we see more and more resistance develop within the society. That's important. If we take the next slide.
As I said, the system also needs to be very reproducible. What you see here on this graph, if we focus on the upper panel first, it illustrates 10 different samples, for three different bug-drug combinations. If you have a high reproducibility, you would expect that all these dots should be, the orange circles should be on a straight line. You report exactly the same result at a given time point. That is, of course, what you want to attain with a system. ASTar is very close to that line, as you can see. When we then compare ASTar with a semi-automated analysis, and in this case, it's not 10 different samples, it's actually replicates, so it should really be an easier situation. We can see that the semi-automated analysis provides much broader range in the results it reports.
Here we can clearly see, I think all the work we have did into ASTar of making the sample preparation, adjusting the concentration of bacteria, and performing then a true MIC value really pays off in reproducibility. I think these are two key aspects that we haven't talked so much about the system, but I wanted to highlight that during today's presentation. If we take the next slide and instead move into really the highlights from the third quarter. As I said initially, to receive such positive feedback from Uppsala University Hospital after testing ASTar in a clinical environment is really what we have all hoped for. It's very easy to use. Anyone can load the sample. It takes very little time, so it's easy to include samples even though you have a lot of other activities going on in the lab.
This, of course, is important because if you look at the microbiology lab today, they are required to run more and more tests with basically the same amount of staff. Of course, to see that ASTar provides a faster or much faster and broader result is of course also very positive. We really look forward now in taking this product to the clinical studies and of course out commercially during next year. I would like to go back and highlight a preclinical study that we did earlier this year together with Uppsala University Hospital. We have further analyzed that and compared the ASTar results with the traditional care. As you can see, the overall results were quite high in both essential agreement and category agreement, both above required guidelines for both Europe and U.S. I would like to highlight one example.
This was a 17-patient study, it was not massively large, but it's not far away from the up to 80 patients we would need in the clinical studies. If we take a look at the next slide. What is clear on a high level is that ASTar was much faster and provided a broader answer, and that's of course all good. In this particular example that I have highlighted here, we have a man, 73 years from New Jersey in the immediate care ward, and he was diagnosed with aspiration pneumonia. That patient went into sepsis. You diagnosed him with that. You took a blood culture, and then immediately prescribed cefotaxime to that patient. Later that day, the blood culture was arriving in the lab, and you had a positive alarm the following day.
You did a Gram stain. At that time point, you could also load the sample into ASTar. Of course, you also went on with the traditional workflow in the lab. You can see that the results from the lab did not come until day three, in the early morning. ASTar actually reported the result that it's resistant towards cefotaxime really day two. Here you can see the value of having a rapid AST with a broader panel. You could have changed and acted on this treatment already Day two, and now we had to wait until Day three. This is just one example of many we expect to see come up with what the value of rapid AST is. Overall, if you compare it to the traditional AST diagnostic regime within the hospital, we performed analysis of 10 more antimicrobials.
In this case, we were 17 hours faster. I think this is a very interesting case study, and of course, this is really what we work for to provide better care for every patient. If we look at next slide. I think I am also very proud to see that most of the analytical study is now complete. Of course, this is an integral part in the future claims for the CE study. First of all, we have now analyzed the most common blood culture bottles in Europe and U.S. We have looked in aerobic and anaerobic lytic bottles, and we know now which eight bottles that will be acceptable to use for ASTar in the early CE release.
Another thing that I think is much more important is that the problem today at the labs is that you can only allow the sample to be run in ASTar, for instance, at a given time interval after it has triggered alarm or been positive in a blood culture cabinet. Initially, actually, we started to have an eight-hour claim, which is quite common in the market of other companies performing rapid AST. When we did timestamp analysis and we realized that in many daytime labs, say you have an alarm during evening in one lab, that means that when the morning shifts come in, it has passed more than eight hours. That sample will not be able to run in ASTar if we have limit ourselves to eight-hour inclusion. We have now expanded and tested that.
We will actually support up to 16 hours past positivity, and we think that will have a dramatic effect on the number of samples that are possible to run in ASTar. Of course, 16 hours is a long time, and ASTar has really been made so if you have staff during the night, anyone can load a sample. This is the real-world situation at many daytime labs. I think this is a very important claim to enable the high inclusion in the product following commercial launch. If we then take the next slide. Another part, which is, of course, quite important, is the stability of our consumables. We are now past four-month stability, and the goal we have for launch is to reach at least six-month stability.
Our prior data has truly indicated more than a year stability for the consumables, and this all puts us in the right direction to actually expand over year stability during 2021. A lot of hard work in the production and validation team on this regard. If we then look at the next slide. I think another key aspect is that we have now received the first commercial instrument delivered to Q-linea. These are what's called the zero batches or pre-production batches, and we see no changes in the instruments for the upcoming commercial launch. We are ready from an instrument perspective. I think also importantly, if you look at the consumer production, we are in formal validation in the entire production process. Also, of course, a key step before commercial launch. We've also increased production capacity 3x compared to beginning of the year.
Of course, this was partly strategy during the year, but also the strong additional funding we secured during June has really helped build up this capacity. We then take the next slide, which I think is needed to be commented here. What are the effects of the corona pandemic on Q-linea? So far, I would say we have not seen any effect that has caused delay on our operations. As I said before, most of our activities are internal. We have adopted the new work routines, and I think the team has managed very well in doing so. We have seen some minimal impact late third quarter or beginning of fourth quarter, actually, but that has been more cost of restrictive guidelines for particular Uppsala.
I think on the positive side, we have throughout this period, having received a strong interest for our clinical partners in both Europe and U.S. to command, start and sign up for the studies. As we saw at Uppsala University Hospital, the preclinical study progressed very smoothly. I think here is really the key to have a system that's easy to operate and really require little time from operator, makes it easier to start or include that sample, for instance, in a study. I must say, and as we all see around us, the dramatic increase in corona, and of course, COVID-19 patients that we see in Uppsala and the rest of the world, I would say the probability is quite high that we see some effect on Q-linea. This can, of course, influence the time to complete the clinical study.
As I said before, and I'm really proud to be able to say that our timeline to start the clinical study remains according to early communication. So far we have been able to manage the situation, but I can't give you any promise for the future, and I think it would be absolutely wrong thing to do so. Apart from that, I would like to hand over now to Anders Lundin, who will talk some more financials, and then I will come back for the last slide of an upcoming webinar. Please, Anders.
Thank you, Jonas. I would go on page 15. The income statement for the third quarter is that we didn't recognize any sales in the third quarter. It's according to what we expect, so we will not see any net sales until we have ASTar launched. We have an operating result of minus SEK 50 million, which was SEK 14 million up from the same quarter last year. We were down SEK 9 million. We were SEK 9 million better than we were in Q2. Third quarter is normally our quarter with lowest expenses due to the vacation period. We reported a loss after tax of SEK -48.7 and earnings per share of SEK -1.80. I go to the next slide, which is the balance sheet. The assets we have here that can be transferred into cash quite easily is, of course, the cash and cash equivalents of SEK 17.8.
We have short-term investments of SEK 205, little more than that, and we have current portion of the listed bonds we have is SEK 151. We have listed bonds of SEK 34. All in all, we have SEK 409 million by the end of the quarter that we can make Oops. Okay. We could go to the next slide, which is the cash flow. We have the cash flow from operating activities is SEK -46.7, and this cash outflow is mainly due to the larger operating loss. We have investing activities of SEK 27.4. That is basically that we are selling the short-term interest funds when we need the cash. That is what we have done the third quarter. Financing activities is small numbers.
Basically, we have some SEK 0.7 minus this quarter. There are some issue expenses related to the right issue in beginning of June that came into the third quarter. We have a repayment of loans. As I said, SEK 409 million we have as easily converted assets to cash. With that, I would like to hand over to Jonas so he can conclude the presentation. Thank you.
Thank you very much, Anders. I would like to bring up the next slide number 18. As you heard now, we've made tremendous progress towards the upcoming clinical study of ASTar. I would like to encourage you to sign up to a webinar we have next week. You can do that on our webpage. We'll of course discuss ASTar in more detail and see the value it can bring in improvement, patient outcome, and ease the life for people working in microbiology lab. I'm actually truly excited also to provide a sneak peek on an upcoming exciting product we have in development here at Q-linea, and it will be followed by a Q&A. The title of the webinar is Equal and Better Care for Everyone, and I would really encourage you to sign up for it.
I think it would be an interesting webinar to listen into. With that, I will just bring up the next slide and conclude our presentation for that, and we'll be happy to answer any questions you might have. Thank you very much.
Thank you. If you wish to ask a question, please dial zero one on your telephone keypads now to enter the queue. Once your name is announced, you can ask your question. If you find your question is answered before it's your turn to speak, you can dial zero two to cancel. Once again, that's zero one to ask a question or zero two if you need to cancel. Our first question comes from the line of Ulrik Trattner of Carnegie. Please go ahead. Your line is open.
Thank you very much. Good day, Anders and Jonas. I have a few questions. To just start off, as you're emphasizing the true value of ASTar is you can obtain a correct or a very exact MIC value. I thought that were beneficial for de-escalating antibiotic use, but it seems like it carries more value than that. Could you please elaborate a bit on that, please?
Yes, of course. Thank you, first of all, Ulrik. You're absolutely right. True MIC values have become more and more important. To also provide the right dosage, particularly for more resistant infection, as you say, to de-escalate. De-escalation can be in a number of things. You want to avoid the multi-drug broad spectrum that you initially start the patient on. You want to de-escalate, of course, to ideally one antibiotic or antimicrobial. As you saw last year, EUCAST changes their guideline from the three categories, S, I, and R, where S means sensitive, I, intermediate, and R, resistant. The intermediate range now is not an area of uncertainty that it has been before.
They actually encourage to use intermediates and actually say that it might be treatable if you can assign the right dosage or the right concentration at site of treatment. For instance, if you have some antibiotics that are concentrated in the urinary bladder, and knowing that the MIC value could really mean that you could use an antibiotic that you might have avoided before, and instead went with a sort of a tougher, more broad-spectrum antibiotics. Having a MIC value, you can actually use the I region in a better way, meaning you can provide a better care with less side effects and also potentially less cost. I think providing MIC values is not just obvious that it's the most precise value. It really changes the escalation regimes, using of the intermediate region, and of course, providing the right dosage.
There are many more sort of values of MIC to bring to better patient care.
Great. Thank you. The second question is on the clinical study, and if you could provide some more detail on the overview of how fast that the CE- IVD approval could be obtained once the study is completed. Also, obviously, 80 to 100 patients should be fairly quickly to include in the study. Could you give us some rough timelines on the retrospective part of the study? Correct me if I'm wrong-
Yes
that is quite a bit larger than the prospective part.
No, you're absolutely right. I'll answer the first question first. When you do the CE study, of course, you will have to run the retrospective and prospective parts. Then, of course, you need to put all the documents together and file and fix the CE mark. Really, we can, of course, do a lot of this in parallel. You continuously build up the registration file as you move through the study. If you do it in the proper way, it means that you will not have a very long period after sort of the last patient in or the last sampling. Of course, you need to verify that with a reference method as well. We don't see the extension of the period after sort of the last sampling to be extremely long.
I will not give you an exact timeline, but we are not talking months for that to be complete. It's more in the week strategy. If we talk about sort of timeline for the study, you are right. The retrospective part is much higher, larger. It's around 10x larger than the prospective part. We would not like today really to give a guidance on the timeline. The reason I would not like to do that is because we see the dramatic increase in COVID-19. We have also seen that everything so far has indicated that we have managed well so far.
We've also seen from, primarily, I would say, Uppsala University Hospital, that even the pre-clinical study we performed in April, it's hard to forget now, but in April was one of the most busy time in COVID patient in Uppsala early this year, and that went really smoothly because it was easy to include the samples. It took a little bit of time in the labs. We also saw that what we have been doing out during the autumn to test it more in clinical studies has also worked nice, although we didn't see the absolute rise in COVID-19 patients at that period of time in Uppsala.
I would not like to give you a firm timeline under the current situation, but what I can guarantee you is that the full team is, from Q-linea and the Thermo Fisher, of course, doing everything to make this as quick as possible. We will, of course, announce when we start the study, obviously, and we'll see if we can provide some general feedback during the study. I know that's not exactly the answer you wanted, but I think that under certain conditions, I think that's really the most sensible answer I can give.
Fair enough. Thank you. You mentioned in the report that you have met with customers during the quarter. If you could please elaborate on that. Geographical presence of these customers, which type of customers, how many have you met so far, and have this been in collaboration with Thermo Fisher? Follow-up on that is, what type of activities are you seeing Thermo Fisher currently committing to? We know that they have held webinars internally, but is there any other activities, and should we expect this to accelerate in the coming months?
Right. Yeah. If I answer the first part of the question, yes, of course. First of all, our primary activities have been meeting customers or potential customers in Sweden. That's going to be for the sales of ASTar. We had a great number of visits during the last couple of months. They have been on-site visits. We are now moving into electronic visits because of the change in the corona situation. I can't give you an exact number, but from a high perspective, we have potentially around 30 key customers in Sweden looking at the larger institutions. I would say that we're halfway through, more or less, on that. Of course, we have a lot of other activities coupled to health economic studies, and we actually receive a lot of interest from customers attending our webinars. We had one earlier this spring.
Thermo Fisher is also hosting webinars on AST in general. We get a lot of feedback for potential customers that ask for more information. Of course, we plan to do that. There, of course, we have a very clear separation that if they are outside Sweden, we of course will provide those leads to Thermo Fisher, and they will have the possibility to contact them. I think also what you will see and what we plan for is, of course, an expanded activity in streams of webinars, presentations from both us and Thermo Fisher. That is, of course, what we plan for as pre-market activities. Of course, we aim for a big launch event at a time point not yet communicated, of course.
I think what you can see is an overall ramping up from both sides, really, to come out to prepare ourselves for the commercial launch that we all worked so hard to accomplish.
Great. Thank you. The last question, and this might be a tough one for you to answer, and it relates to the last slide of this presentation. One could suggest that is a teaser for the webinar. Based on that picture, doesn't look like either AST or an IVD instrument, in my view. What type of conclusions could we draw from that, or do we need to wait for the webinar next week?
Yes. I would say you need to wait. I would also say that it's a fairly fair conclusion from our side, the one you have made. I really would encourage you to sign up for it. I think it's going to be an interesting part. Of course, the primary work we have now is to provide more details on ASTar and the value it can bring. We as a company, we always focus for the long-term success of Q-linea, and we see a lot of areas in treatment of extra patients where we have technology and, of course, IVD support to develop products. We look at the big pictures, really from A to Z in the diagnostic workflow. We are not resting.
We have seen ASTar taking a big step now towards clinical studies. We had a number of interesting activities over the year that really encouraged us to also, of course, in parallel, develop other products that we think is going to be very interesting if we manage to take them to market, of course.
Perfect. Thank you. That was all for me for now, and I'll go back to queue. Thank you.
Thank you, [audio distortion].
Our next question comes from the line of Victor Forssell of ABG Sundal Collier. Please go ahead. Your line is open.
Thank you very much, and good day, everyone. A few from my side, if that's okay. I'll start with the one with the overall situation in Uppsala at the moment and just a couple of last week's dynamics and stringent restrictions. I think that you alluded to it in the presentation. Is it even fair to assume that even when Uppsala will start both, it's part of the study that even this part could be prolonged given reallocation of staff and internal efforts, if that's what you alluded to. Is that correct?
First of all, hi, Victor. No. Well, of course, the situation in Uppsala is escalating, and we have some new guidelines
Hello. Apologies, we seem to have lost our speakers. Bear with us just one moment as we reconnect them. We will just put the call on hold for a moment. Ladies and gentlemen, we are back on the call now. I will unmute Victor again, and your line is open, Victor.
Okay. If you can hear me now, we had a dropout. It's not just COVID that affects us apparently. To continue to answer your question, Victor, well, yeah. What we see is more a change in the guidelines in how we work and how we operate. We see some effects, I would say still minor. We have been able to manage it well. From the study perspective, you are correct. We could see a prolongation of the study. There are two reasons we could see that. Either if we have a lot of people within the company that track COVID-19. That is, of course, what I try to protect and try to work to mitigate or fight against. We could see, for instance, that the hospital will have a lower inclusion rate. That can happen for sure if they need to prioritize it.
I think the positive part is what we have seen. We have been running a preclinical study and test period under the COVID-19 situation, and that has gone very well. I'm still positive. I think it's the right place to announce that we might see a delay. We haven't seen it, but I can't say that it will not come.
Yeah, that sounds very fair. If I move over to the site in Denmark, just to give a sense or any comment really about the installation phase of ASTar in Denmark also. If you've been able to do something in terms of educating the staff, et cetera. If not, do you feel certain that the access to do this will be all right given where we are now with COVID again?
No, you're right. We have been, of course, doing pre-site visits and prepare for that. Also, I should say that the hospital in Denmark, Hvidovre Hospital, they have really been active in the part of ASTar and been doing a lot of usability. They are more or less up to speed with the system. You need to have an official training as part of the documentation for the CE, and that has not been performed yet. You're right, we might see a situation where Denmark closes, or we haven't seen it yet. We'll also look at possible mitigation. We are in contact with additional sites. If that happens, we plan to make a smooth shift. We are already preparing for the worst, so to speak, but also expecting it to go on schedule. We have a very strong commitment from Hvidovre Hospital.
They really want to participate. They want to see a prioritization of ASTar. We are on the good side, but we'll also try to plan for if the worst happens, so to speak.
No, that sounds good and helpful. Moving over to the U.S. market, obviously, I appreciate that there is limited access to certain regions and travel restrictions and whatnot. Perhaps this question becomes a bit hypothetical, but what would you say is holding you back at this moment where we are from securing two U.S. sites and then obviously apply for the 510(k) very briefly after the EU study? Coupled to that, what should we think is a realistic timeframe until FDA could receive all the documents needed?
Right. It's a little bit harder to give a final call on that. What we have seen, and as we said, we needed to postpone the discussion with the U.S. side because of that dramatic increase earlier this year in the U.S., basically shut down. We have, of course, restarted that, and we are now in a very good position in acquiring and contracting sites for the study. That has actually progressed very smoothly, even under this situation. For sure, you will see a little bit of a stage before Europe and U.S. I would like to come back to you when we have the final agreements in place. Be a little bit cautious on providing that timeline. I still think that under these situations, it's truly proven that the value of having Thermo Fisher as a worldwide partner.
They have, of course, already people on the ground in the U.S., and they can also really be helping out and participating in the study and are quite willing to do so. I think here, even if the situation turns to the worse with travel restrictions, we are, of course, trying to plan for that as well. I would say that I'm truly happy to have Thermo Fisher as a partner. Strong support, strong commitment, and they have a worldwide presence. At least I think it puts us in a better position. I would like to be a little bit cautious now. We also will have to follow the election and if there might be some new guidelines coming up after that. From a study perspective, talking to sites and planning, it's going very well, I would say.
Okay, great. Just a final follow-up on that. What is the feedback you hear from the market or from Thermo Fisher in terms of what could perhaps become a backlog for FDA as well, and whether you, for some reason, get a sense of if you could get prioritized or not? Would be very interesting to hear some of the dynamics here.
Right. I think it's true. If you looked at the FDA workload during at least summer and the spring, they had a lot of activities approving or clearance of COVID testing. I think you do right to assume that they have a backlog for sure. The next phase, hopefully, we all hope for will be vaccine clearance. I think also what's important, and of course, that's very hard to judge. Where do you put AST on the priority ladder? We also saw, that was a couple of years ago, FDA really prioritized rapid AST testing.
I think it's important to remember that although we have a terrible situation of COVID-19 now. We see that sepsis is the number one killer year by year in the U.S. and in Europe, and it accounts for the biggest single diagnosis for healthcare cost in the U.S., more than $24 billion just for sepsis. I think that it's definitely a high priority area, but it's of course impossible for me to say what would be the top priority. I should say that if you have a vaccine that needs to be cleared, that should be the top priority. I would not like to say that. We had a couple of interactions with FDA during the autumn for finalizing some parts of the U.S. planning. There we had very swift response from our person in FDA.
Again, promising in the past, we will see how the future looks.
Okay, thanks a lot. I'll get back in queue for now.
Thanks very much, Victor.
Thank you. We have one further question in the queue so far. It's from the line of Alex [audio distortion ]. Please go ahead, your line is open.
Hi, guys. Thanks for taking my question. I think overall, part of it's been addressed so far. Given all the different moving parts, could you just walk us through the steps towards commercialization in Europe and then separately, the next steps towards commercialization in the U.S.? The second question I have regarding your prospective trial, could you give us a sense of the benchmark results that you need to achieve to qualify for CE marking? Thanks.
Yes, of course, and hi, Alex. If we look at the steps for commercialization, I would say, of course, pre-activities have already started naturally. Really the next step for us, if we start with Europe, is to perform the retrospective and prospective part of the study. Really we are lining up our internal organizations to be absolutely ready immediately when that happens. That is the phase for Europe. Of course, we have together assessed and prioritized regions. We already have interest from customers that want to know more about ASTar. We are, of course, looking into that. We really hope and aim for that the phase after the CE mark could provide a swift move over to the commercial environment. If we then look at the U.S., I would say the situation would be sort of similar.
The difference, of course, is that we first have to complete the U.S. trial, we have a bigger issue with the COVID in the U.S., I would say primarily due to regulations. There are still some states that are not as affected as others. This might change on a daily notice. Of course, we'll then need to file for a 510(k) clearance, which is the category our product would fall within. I think also in the U.S., I think the benefits we have if we are successful in Europe is that we can also build from wording from key opinion leaders and start addressing customers. I think the feedback we have received now while we are out contracting sites for participation in the U.S. study, there's a tremendous interest. I think that is on the positive side.
We'll of course have to see what the financial effects might be on the U.S. healthcare system. I really see it now as a stepwise approach. We are aligning, and we'll be ready the day we fix the CE mark for sure. If we then look at your second part of the question, the targets we need to attain, on a high level, you have the essential agreement, meaning that you provide the same result as the reference method. You need to provide 90%. That's the same for Europe and U.S. U.S. actually have 89.9%, let's round that up. Then you have the categorical agreement. Again, you have to be above 90%, and that's to provide the treatment categories, the S, I, and R. Of course, you have reproducibility.
I think as I've shown today, we have an absolutely excellent reproducibility of our study or in our system. There we are really acing it, so to speak. Those are really the primary endpoints that we'll be measured up against. They are very similar for Europe and U.S. I would say the slight difference to the U.S. environment is they have a little bit more of the interference testing that they would like to perform or see performed. I think the way we have designed our solvent preparation to really remove everything that's not the viable pathogen has indicated clearly that we are strong in that regard. As you could see, we have maneuvered through all of the most common blood culture bottles with more or less close to 100% performance.
I would say that that's really the difference from the U.S. part from the Europe study. I hope that answered your question, Alex.
Yes. No, absolutely. That's very helpful. Maybe on the path to European commercialization, you mentioned obviously there's a prospective and then the retrospective study, which I understood earlier, the timing of which is a little bit uncertain, and then CE marking. Am I understanding right that the CE marking is still targeted towards 2021?
Absolutely. Definitely, yes.
Right. In terms of how commercialization would occur on the back of the CE mark, is there already a plan in place together with Thermo Fisher, any specific geographies that would be targeted first? Just trying to think of how revenue could potentially build up next year.
Right. Yeah. I can't communicate the exact details, but there's a clear priority on where we would like to go first. Yes. That's already been in the planning. It's ready, so to speak. We are prepared, and we have a priority on, for many good reasons, why we'd like to put the efforts first for ASTar.
Right. Is it fair to assume that the U.S. launch is roughly one year after CE marking?
I would not like to give or provide an exact timeline for that. I would rather focus first on the FDA filing when we file for approval. The FDA has supposed to deliver an answer in three months. We know that under the COVID flag, it might not happen. Definitely, that should be a good goal to aim for sure.
Okay. Thank you. That's it from me.
Thank you so much, Alex.
Thank you. We've had a follow-up from Victor Forssell at ABG. Please go ahead, your line is open.
Yes. Hi, thanks for taking my follow-up. Perhaps you can answer to this, but in terms of a launch here in the beginning of next year in Europe, do you currently see any sort of risk or hindrance of you for the adoption rate compared to perhaps what you could do in the U.S., as Accelerate has been a pioneer in that market? If there is by any chance that you could give a sort of a range or scenarios for what you feel comfortable in terms of placements in Europe for next year. I know that you alluded to, you've been talking to 30 customers in Sweden during this autumn. Is it fair to assume that all those 30 could potentially see a placement at those sites already next year? Thanks.
Right. If I take the first part of your question first. I would not say really. Of course, we have seen more Pheno system placed in the U.S. compared to Europe, for sure. I still think that if you look at the overall ASTar value proposition and what we could bring to this group of customers, I would not really see that as a hindrance. Of course, if you have a site that has fully adopted the Pheno system, of course, that's going to be a challenge. We don't really see so many sites that are fully committed of running all the samples for many reasons on that platform. I think that the U.S. as a market is still very interesting in the way they prioritize and the way they use these type of rapid tests.
I would not say that I see a hindrance because of that in the U.S. market. I think it's balanced out by the drive for these type of tests. I think also the capacity we have in tests really supports these larger institutions, larger hospitals, they have a vast amount of blood cultures that they need to analyze. Of course, that's looking into the future, no one knows, but I would not say that that's something we are particularly considering to be an issue. If you go back to the placement during next year, and to be correct, if I didn't, I said we've probably talked to half of the potential 30 customers in Sweden. I would, of course, absolutely love to have every single site adopting ASTar.
I think what's really most important for me and for our company is that when I look at our technology, I always plan to be an absolute successful company in the five and 10-year range, to be there in the long run. I also honestly think that the most successful companies, they do a much more, I would say, careful placement in the initial phase of a launch to really make sure that we place it at the right customers, to evaluate and really get ready to have any sort of early diseases that you want to wash out in the system. I think if you do it that way, it really enables you to have a much, much faster ramp-up as sort of a second stage.
Of course, we have internal plans for placement for next year, but for now, I think I will keep them to myself, and then we hope we beat whatever plan we have for next year anyway. I know, again, it doesn't really answer your question, but I hope you understand that I don't want to give a firm announcement today on that.
No, I understand. I think it also answers the last question that I have given. Where we are now approaching the launch, it would be interesting to hear about the split between capital placements and reagent rentals. I think that you perhaps answered that, we should expect you to shoot more for capital placements initially that ultimately in the coming years would trend more towards reagent rentals. Is that a fair assumption?
I'm not necessarily agreeing on that. I think the type of sales drive depends a little bit on the institution. And of course, for all customers outside Sweden, that will be handled by Thermo Fisher, and they have really many type of options for this. It could also be a lease type option. I think it would depend a little bit on what we target. I would not say that we aim for capital first, the reagent rental later. I think we aim for the right institutions, and they will find the best one for that institution to sort of support the uptake of ASTar.
Yeah. Okay. Thank you very much.
Thank you very much, Victor.
Thank you. Once again, if there are any final questions, please dial zero one on your telephone keypads now. Okay, there seem to be no further questions at this time, so I'll hand back to our speakers for the closing comments.
All right. Thank you very much for all the questions and comments during this presentation. We all, of course, look forward to coming back to you and really now at the start of the study, and of course, aiming for very positive uptake during next year. With that, we'll conclude the session from our part. Of course, be safe and practice social distancing so we can fight this pandemic together. Thank you very much from us.