Earnings Call: Q3 2020

Nov 5, 2020

First of all, welcome to our presentation today, where we're going to announce our achievements and financial position during the Q3. Before we go into the presentation, I would like to call up the next slide, which shows our disclaimer in case in the year end that we make any forward looking statements. And with that, I would present the next slide, which is really the Q3 at a very high level. And of course, we'll provide more details during the rest of the presentation. As you know, at Kolinia, we are developing innovative and disruptive solutions for faster and better infectious disease diagnostics. The first product started being sepsis, but Avstar has really been the platform to support many other applications to follow blood cultures. If I'm going to highlight one thing, in particular during the Q3, I would say that it's really the excellent feedback received for clinical use of Aspar at Uppsala University Hospital. I will come back to that. But it really indicates that all work we have performed during the last couple of years have paid out. And of course, another very important step is all the work done in preparation for the upcoming clinical study of Astar. And I must really say that I'm truly proud of the team at Culenia with the dedication and motivation and all the hard work that has been put in on taking our start into the first clinical studies. If we look at the company in general, we have grown according to plan and are now 100 and 30 4 employees and consultants at quarter end. And 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. So 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. And here I would say, as we mentioned, sepsis is our first product. It's truly a global health crisis. It affects 50,000,000 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 500,000 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. And time here is of essence because if you're on the wrong treatment when you're entering septic shock, the likelihood of mortality increases close to 8% every hour. And this is, of course, the area where Astra would like to present a dramatic improvement. So 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 to detail, you can see that every gray circle corresponds to a manual staff or analysis of the sample in the diagnostic workflow. It's a multiday, multistap process. And of course, as you would like to have is a green circle today indicated at day 4. And that is when you can first really know what antibiotic or antimicrobial is going to treat that patient's particular infection. So if you look at the bottom graph, of course, not only do ASTA reviews dramatically the number of manual steps needed to be performed on the sample, it also produces the results much, much faster. So up to 40 hours faster with very little due to intervention on the system. And I think it's important to remember that time to action result 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 4 pillars that Aptar has been built upon. And this has been done in close collaboration with a number of hospitals in various settings throughout the world. And I would say that one absolute key is the ease of use of the system. Our driver has always been that anyone at lab should be able to start analysis at any given time point. So of course, it needs to be fully automated. We also need to have a very short hands on time. It's less than a minute on half star. And we'll also build it according to 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 3 to 6 hours, and we do that at a very high throughput. So 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 of various categories of bacteria that you can find in septic patients but, of course, all the other infections. And Ashtar is designed as a platform. We have already illustrated and shown data on urine or for instance, isolates. So we see that there are many possible add ons to come in the future of the system. But that's, of course, good if it's comprehensive. But any result also needs to be accurate. And what we're seeing today in the ever escalating increase in the antimicrobial resistance, we've seen the value of true MIC results. And MIC stands for the minimum inhibitory concentration, meaning the concentration that kills or inhibit bacteria. That's the highest precision you can deliver in a susceptibility test. And that, of course, needs to be reproducible. So I will look at these two things a little bit more in detail. So if you take the next slide, this is an example, and I will walk you through it. So what you see on this graph on the y axis is the probability of target payment during a treatment regime. And on the x axis, you can see various MIC concentrations, I mean, the concentration that would kill or inhibit bacteria. Then you have 5 different graphs, all coupled to different treatment regimes. For instance, the concentration on sample, the time for infusion and intervals in between infusions. And what is quite clear is that when you have low mix values, you can see that almost all these treatment machines are equally as effective. You want to be very close to 1 here. But it's also quite clear that if you have a high MYC value of this particular bacteria, we can see that it's only the orange line that will provide effective treatment, meaning 1 gram every 8 hour during a 3 hour infusion. So unless you actually have the MYC value, the likelihood of treating this particular patient to be wrong is quite high. So the value of MYC, I would say, becomes more and more important when we see more and more resistance develop within the society. So that's important. If we take the next slide, as I said, the system also needs to be very reproducible. So what you see here on this graph, if we focus on the upper panel first, it illustrates 10 different samples for 3 different bug wrap combinations. And if you have a high reproducibility, you would expect that all these dots should be the orange surface should be on straight line. Then you report exactly the same result at a given time point. And that is, of course, what you want to obtain with the system. And Astra is very close to that line, as you can see. When we then compare Astra with a single 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 SIM automated analysis provides much, 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. So I think these are 2 key aspects I 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 Q3. As I said initially, to receive such positive feedback from Uppsala University Hospital after testing at SARS 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 a microbiology lab today, they are required to run more and more tests with basically the same amount of cells. Then, of course, to see that Astra provides a faster or much faster and broader result is, of course, also very positive. So we really look forward now in taking this product to the clinical studies and, of course, out commercially during next year. But I would like to go back and highlight a preclinical study that we did earlier this year together with OXO University Hospital. We have further analyzed that and compared the after 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 in both Europe and U. S. But 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 will need in the clinical studies. So if we take a look at the next slide. What is clear on a high level is that asthma was much faster and provided broader answer. That's, of course, all good. But in this particular example that I have highlighted here, we have a man, 73 years from neurosurgery in the immediate care ward, He was diagnosed with aspiration pneumonia. That patient then went into sepsis here, diagnosed him with that. He took a blood culture and then immediately prescribed zivotaxim to that patient. Later that day, the blood culture was arriving in the lab and you had a caustic alarm the following day. You did a gram stain. And at that time point, you could also load the sample into F star. And of course, you also went on with the traditional work from the lab. You can see that the results from the lab did not come until day 3 in the early morning. But Aspar actually reported the result that is resistant towards cepataxine really day 2. So here you can see the value of having a rapid ASG with a broad panel. You could have changed and acted on this treatment already day 2 and now we had to wait until day 3. So this is just one example of many we expect to see come up with what's the value of rapid AST. And 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. So 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 then look at next slide, I think I'm also very proud to see that most of the analytical study is now complete. And 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 analytic bottles, and we know now which 8 bottles that will be acceptable to use for Astar in the early CE release. But 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, a given time interval after it has triggered alarm or been positive in a blood culture cabinet. Initially, actually, we started to have an 8 hour claim, which is quite common in the market of other companies performing rapid ASG. But when we did timestamp analysis and we realized that on many daytime labs, say you have an alarm during evening in one lab, that means that when the morning trips come in, it has passed more than 8 hours. So that sample will not be able to run-in Ashtar if we have limit ourselves to 8 hour intrusion. So we have now extended and tested that. So we will support up to 16 hours PAS 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 to reunite, anyone can order a sample. But this is the real world situation that manage daytime labs. So I think this is a very, very important claim to enable a 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 4 months stability and the goal we have for launch is to reach at least 6 months 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. So 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 1st commercial instrument delivered to Killinja. These are what's called the share batches or preproduction batches. And we see no changes in the instruments for the upcoming commercial launch. So we are ready from an instrument perspective. I think also importantly, if you look at the consumer production, we are in form of validation in the entire production process, also, of course, a key step before commercial launch. And we've also increased production capacity 3x compared to beginning of the year. And of course, this was partly strategy during the year, but also the strong additional filing we secured during June has really helped build up this capacity. If we then take the next slide, which I think is needed to be commented here, what are the effects of the corona pandemic on chilemia? And so far, we say we have not seen any effect that has caused a delay on our operations. And as I said before, most of our activities are internal. We have adopted a new work routines and I think the team has managed very well in doing so. We have seen some minimal impact late Q3 or beginning of Q4 actually, but that has been more coupled to stricter guidelines for particular SOLA. 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 commence start and sign up for the studies. And as we saw at academic universal hospital, the preclinical study progressed very smoothly. And I think here is really the key to have a system that's easy to operate and really require little time from the operator. It makes it easier to start or include that sample, for instance, in a study. But I must say, and as we all see around us, the dramatic in corona and, of course, COVID-nineteen 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 chalemia. And this can, of course, influence the time to complete the clinical study. But as I said before, and I'm really proud to be able to say that our time line to start the clinical study remains according to early communication. So, 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. 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 to the last slide of an upcoming webinar. But please, Anders. Thank you, Jonas. I would go on Page 15. And the income statement for the Q3 is that we didn't recognize any sales in the Q3. It's according to what we expect. So we will not see any net sales until we have Asta launched. We had an operating result of minus SEK 50,000,000, which was SEK 14,000,000 up from the same quarter last year. We were down $9,000,000 we were $9,000,000 better than we were in Q2. And 3rd quarter is normally our quarter with lowest expenses due to the vacation period. We reported a loss after tax of minus €48,700,000 and earnings per share of minus €1.8 So then I go to the next slide, which is the balance sheet. So we have 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 percent. We have short term investments of 205 percent, a little more than that. And we have current portion of the listed bonds we have is SEK 151,000,000 and we have listed bonds of SEK 34,000,000. So all in all, we have SEK 409,000,000 by the end of the quarter that we can make them. Okay. So we could go to the next slide, which is the cash flow. So we have the cash flow from operating activities is minus SEK46.7 billion, and this cash outflow is mainly due to the larger operating loss. We have investing activities of 27,400,000,000 and that is basically that we are selling the short term interest funds when we need the cash. So that is what we have done in the Q3. And financing activities is small numbers. It's basically we have some 0.7 minuteus this quarter and there are some issue expenses related to the right issue in beginning of June that came into the Q3, and we have those repayment of loans. So as I said, dollars 409,000,000 we have has easily converted assets to cash. So by that, I would like to hand over to Jonas, so he can conclude the presentation. Thank you. Thanks very much, Anders. So I would like to bring up the next slide, Slide number 18. As you heard now, we've made tremendous progress towards the upcoming clinical study of Aspar. I would like to encourage you to sign up to a webinar we have next week. You can do that on our webpage. But we'll, of course, discuss ASKAR in more detail and see the value it can bring in improving patient outcome and ease the life for people working in microbiology lab. But I'm actually truly excited also to provide a sneak peek on upcoming exciting product we have in development here at Kilynia, and it will be followed by a Q and A. So the title of the webinar is equal and better care for everyone and I would really urge you to sign up for it. I think it would be an interesting webinar to listen into. But with that, I will just bring up the next slide and conclude our presentation for that. We'll be happy to answer any questions you might have. Thank you very much. Thank you. Our first question comes from the line of Ulrich Schrapner of Carnegie. Please go ahead. Your line is open. Thank you very much and good day Anders and Jonas. I have a few questions. To just start off, as you're emphasizing the true value of Astra is you can obtain a correct or a very exact mix value. And I thought that were beneficial for de escalating antibiotic use, but it seems like it carries more value than that. Can you please elaborate a bit on that, please? Yes, of course. Thank you, first of all, Ulrik. No, you're absolutely right. I mean, true MIC values have become more and more important. First of all, to also provide the right dosage, particularly for more resistant infection, but then also, as you say, to deescalate. And deescalation can be in a number of things. First, of course, you want to avoid the multi drug broad spectrum that you initially start the patient on. So you want to deescalate, of course, to IDD1 antibiotic or antimicrobial. But also, as you saw last year, UCaaS changes our guideline from the 3 categories, S INR, where S means sensitive, I intermediate and R resistant. The intermediate fringe now is not sort of an area of uncertainty that it has been before. They're actually encouraged to use intermediates and actually say that it might be treatable if you can assign the right dosage or the right concentration at sites of treatment. For instance, if you have some antibiotics, they are concentrated in the urinary bladder. And knowing then 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. But having a mix value, you can actually use the eye region in a better way, meaning you can provide a better care with less side effects and also potentially less cost. So I think providing MIC values is not just the obvious that it's a most precise value. It really changes the escalation regimes using of the intermediate region and of course providing the right doses. So there are many, many more sort of values of MIT to bring to better patient care. Great. Thank you. And 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? And also, obviously, 80 to 100 patients should be fairly quickly to include in this study. But could you give us some rough time lines on the retrospective part of the study? Because correct me if I'm wrong, that is quite a bit larger than the prospective part. You're absolutely right. So I'll answer the first question first. So when you do the CE study, of course, you will have to run the retrospective and prospective parts. And then, of course, you need to put all documents together and file and fix the CE mark. Really, we plan, of course, to do a lot of this in parallel. So you continue to build up the registration file as you move through the study. And 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. So 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 weak strategy. If we then talk about sort of time line for the study, you are right, the retrospective part is much higher larger. It's around 10x larger than the prospective part. And we would not like today really to give a guidance on the time line. And the reason I would not like to do that is because we see the dramatic increase in COVID. 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, of the University Hospital that even though the preclinical study we performed in April, it's hard to sort of forget now, but in April, it was one of the most busy time in COVID patient Uppsala early this year, and that went really smoothly because it was easy to include the samples. It took a little bit time in the labs. And we also saw that what we have been doing out during the launch of testing morning clinical studies has also worked nice, although we didn't see the absolute rise in COVID-nineteen patients at that period of time in Uppsala. So I would not like to give you a firm time line under the current situation. But what I can guarantee you is that the full team is from Khelinya and Thermo Fisher, of course, doing everything to make this as quick as possible. And we will, of course, announce when we start the study, obviously, we'll see if we can provide some general feedback during the study. I know that's not 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 they been in collaboration with Thermo Fisher? And sort of follow-up on that is what type of activities are you seeing in Thermo Fisher currently committing to? We note that they have held webinars internally, but is there any other activities? And should we expect this to accelerate in the coming months? Right. Yes. So if I answer the first part of the question, yes, of course. First of all, I mean, our primary case has been meeting customers or potential customers in Sweden. That's going to be for the sales of Aspar. And we had a great number of visits during the last couple of months. They have been on-site visits. We are now moving into electronics visits because of the change in the corona situation. And I can't give you an exact number, but from a high sort of perspective, we have potentially around 30 key customers in Sweden looking at the larger institutions. And I would say that we are halfway through more or less on that. Then, 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 Fishers also hosted webinars on AST in general. So we get a lot of feedback from potential customers that ask for more information. So of course, we plan to do that. But 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. So that is, of course, what we plan for as pre market activities. And then, of course, we aim for a big launch event at a time point not yet communicated, of course. So I think what you can see is an overall ramping up from both sides really to come to prepare ourselves for the commercial launch that we will work so hard to accomplish. Great. Thank you. So the last question, and this might be a tough one for you to answer, and it relates to the last slide of this presentation. And one could suggest that at a teaser for the webinar and based on that picture doesn't look like either AST or an ICE instrument in my view, what type of conclusion 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 just made. But I really would encourage you to sign up for it. And I think it's going to be an interesting part. Of course, the primary work we have now is to provide more details of Astar and the value it can bring. But we as a company, we're always focused for the long term success of Chilenia. And we see a lot of areas in treatment of exogenous patients where we have technology and of course IT support to sort of develop products that we look at the big features really from A to Z in the diagnostic workflow. So we are not sort of resting. We have seen us start taking a big step now towards clinical studies. And 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 the queue. Thank you. Thank you, Tomas. Our next question comes from the line of Victor Vorsell of APG. 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, I mean, overall situation in Uppsala at the moment and just a couple of last week dynamics and stringent restrictions. I mean, I think that you alluded to it in the presentation. But is it even fair to assume that even when OXXOLLA will start both I mean, 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, I mean, 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'll just put the call on hold for a moment. Ladies and gentlemen, we're back on the call now. So I will unmute Victor again. And your line is open, Victor. Okay. So if you can hear me now, we had a dropout. It's not just COVID that affects us apparently. But to continue to answer your question, Victor, well, yes, 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. I mean, there are two reasons to see that either if you have a lot of people within the company that track COVID-nineteen. That is, of course, what I try to protect and try to work to sort of 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. But I think the positive part is what we have seen. I mean, we have been running a preclinical study in test period under the COVID-nineteen situation, and that has come very, very well. So I'm still positive, but 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. Yes. No, that sounds very fair. And if I move over to the site in Denmark, just to give a sense or any comment really about the installation phase of Aasta in Denmark also, if you've been able to do something in terms of educating the staff, etcetera. And if not, I mean, 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. So we have been, of course, doing piece like visits and prepare for that. Also, I should say that Dostre in Denmark, from Bjorn von Lispi, they have really been active in the part of Ascar and been doing a lot of usability. So they are more or less up to speed with the system. Then you need to have an official training as part of the documentation for the CE, and that has not been performed yet. So you're right, we might see a situation that where Denmark closes or we haven't seen it yet. And we also as I mentioned, we also look at possible mitigation. So we are in contact with additional sites. So if that happens, we plan to make a smooth shift. So we are already preparing for the worst, so to speak, but also expecting it to go on schedule. We have a very, very strong commitment from if the worst happens, so to speak. No, that sounds good and helpful. Moving over to the U. S. Market. Obviously, appreciate that there is limited access to certain regions and travel restrictions and whatnot. And perhaps this question becomes a bit hypothetical, but what would you say is holding you back at this moment where we are from securing to U. S. Sites? And then obviously applied for the 510 very briefly after the EU study? And coupled to that, what should we link as a realistic time frame until FDA could receive all the documents needed? Right. Yes. So it's a little bit harder to give a final call on that. So what we have seen, as we said, we needed to postpone the discussion with the U. S. Side because of that dramatic increase during 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. And that has actually progressed very smoothly even under these situations. So for sure, you would see a little bit of a stage before Europe and U. S. And I would like to come back to you when we see that when we have the final agreements in place. So be a little bit cautious on providing that time line. 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. So I think here, even if the situation sort of turns to the worse with travel restrictions, we are, of course, trying to plan for that as well. And 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. So at least I think it puts us in a better position. But I would like to be a little bit cautious now. We also want to not want necessarily, but we'll have to follow the election and there might be some new guidelines coming up after that. But from a study perspective, talking to sites and planning, it's going very well, I would say. Okay, great. And 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, it would be very interesting to hear some of the dynamics here. Right. Yes, I think it's true. I mean, if you looked at the FDA sort of workload during at least summer and spring, I mean, they had a lot of activities approving or clearance of COVID testing. So you could I think you do right to assume that they have a backlog for sure. And 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 sort of priority ladder. But we also saw, and 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-nineteen 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 hep care costs in the U. S, more than US24 $1,000,000,000 just for sepsis. So 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. And I should say that if you have a vaccine that needs to be cleared, that should be the top priority. So I would not to say that we had a couple of interactions with FDA during the autumn for sort of finalizing some parts of the U. S. Planning. And there we have very swift response from our person and FDA. So again, promising in the past, we would 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. That's from the line of Alex Kugut of Kempen and Co. Please go ahead. Your line is open. Hi, guys. Thanks for taking my questions. So I think overall, part of it's been addressed so far. But given the all the different moving parts, could you just walk us through the, the steps towards commercialization in Europe? And then separately, the next steps towards commercialization in the U. S? And then as a 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. So 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 perspective part of the study. And then really, we are lining up our internal organizations to be absolutely ready immediately when that happens. So 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 ADSTAR. So we are, of course, looking into that. So we really hope and aim for that the phase after the CE Mark could provide sort of 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 and we have a bigger issue with 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. Then, of course, we will then need to file for a 510 clearance, which is the category our product will fall within. And I think also in the U. S, I think the benefit we have if we are successful in Europe is that we can also build from wordings from key opinion leaders and start addressing customers. And I think the feedback we have received now when we are out contracting sites for participation in the U. S. Study, there's a tremendous interest. So I think that is on the positive side. We, of course, have to see what the financial effect might be on the U. S. Healthcare system. But I really see it now as a stepwise approach. So 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, I mean, on a high level, you have the essential agreement, meaning that you try 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%, but let's round that up. And then you have the categorical agreement. Again, you have to be above 90%, and that's to provide the treatment categories that adds INR. Then, 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. So there we are really pacing it, so to speak. So those are really the primary endpoints that we'll be meshed up against, and 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 interference testing that they would like to perform or see performed. And I think the way we have designed our sample preparation to really remove everything that's not a viable pathogen has indicated clearly that we are strong in that regard. And as you could see, we have maneuvered through all of the most common culture bottles with more or less close to 100% performance. So I would say that that's really the difference from the U. S. Part from the Europe study. I hope that answers your question, Alex. Yes. No, absolutely. That's very helpful. Maybe on the path to European commercialization, you mentioned obviously the perspective 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 bright as the CE Mark then is still targeted towards 2021? Absolutely, definitely, yes. Right. And then 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. Yes. I can't communicate exact details, but there's a clear priority on where we would like to go first, yes. That's already been in the planning and it's ready, so to speak. So we are prepared and we have a priority on for many good reasons why we'd like to sort of put the efforts first for Astar. Right. And is it first to assume that the U. S. Launch is roughly 1 year after CE Marking? I would not like to give or provide an exact time line for that. I would rather focus first on the FDA filing when we file for approval. I mean, the FDA has supposed to deliver an answer in 3 months. We know that under the COVID flag, it might not happen. But definitely, that should be a good goal to aim for sure. Okay. Thank you. That's it for me. Thank you so much, Alex. Thank you. And we've had a follow-up from Mervik Forschule at ABG. Please go ahead. Your line is open. Yes. Hi, and thanks for taking my follow-up. Perhaps you can answer to this. But in terms of a launch here in the beginning or 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? And also, if there is by any chance that you could give us 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. I mean, is it fair to assume that all those thirty could potentially be see a placement at those sites already next year? Thanks. Right. So if I take the first part of your question first, I would not say really that of course, we have seen more Finosystem placed in the U. S. Compared to Europe, for sure. I still think that if you look at the overall asset value proposition and what we could bring to this group of sort 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. But we don't really see so many sites that are fully committed of running all the samples for many reasons on that platform. So 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. So I would not say that I see a hindrance because of that in the U. S. Market. I think it's balanced out by quite a drive for these type of tests. I think also the capacity we have built into the test are really supports these larger institutions, larger hospitals they have a vast amount of blood pressure that they need to analyze. So of course, that's looking into the future, no one knows. But I will 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 third customers in Sweden. I would, of course, absolutely love to have every single site adopting Astar. But 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 5 10 year range, to be there in the long run. And I also honestly think that the most successful companies, they do much more, I would say, careful placement in the initial phase of a launch to really make sure that you place it on 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. And 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. So of course, we have internal plans for placements for next year. But for now, I think I will keep them to myself. And we hope to beat whatever plan we have next year anyway. So 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. And 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 RioGen rentals. So but I think that you perhaps answered that, that you 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 the fair assumption? I'm not necessarily agreeing on that. I think the type of sales trend depends a little bit on the institution. So and of course, I mean, for most on 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. So I think it would depend a little bit on what we target. So I would not say that we aim for capital first, the region trends later. I think we aim for the right institutions, and then we'll find the best one for that institution to sort of support the uptake of Avstar. Yes, okay. Thank you very much. Thank you very much, Victor. Thank you. Okay. There seems to be no further questions at this time. So I'll hand back to our speakers for the closing comments. All right. So thank you very much for all the questions and comments during this presentation. And 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. So with that, we'll conclude the session from our part. And of course, be safe and practice social distancing so we can fight this pandemic together. Thank you very much from us.