Q linea AB

STO:QLINEA

Earnings Call Transcript 2021-Q3

[Operator]

Ladies and gentlemen, welcome to Q-linea Audiocast Teleconference Q3 2021. Today, I am pleased to present CEO, Jonas Jarvius; and CFO, Anders Lundin. [Operator Instructions] Speakers, please begin.

[Jonas Jarvius, CEO & President]

So thank you very much for that, and welcome, everyone, to our presentation for the third quarter for 2021. Q-linea, we are working hard to future-proof health care to make it sustainable for new generation.If we go into the presentation, we'll go to Slide #2. Here, we show our disclaimer slide. In the case me or Anders will make any forward-looking statements during the presentation. Having stated that, I suggest we go to Slide #3, which is really a high-level summary of the third quarter this year.I can summarize the quarter has really been a preparation quarter. It's been in preparation for the commercial launch together with Thermo Fisher that happened just after the period end. I'll comment on that later in the presentation. Also, preparation to take the next step in the clinical studies for the U.S. market and also preparation to take our portable culture device technology to the next steps. So apart from that, we have been growing the company according to plan. We are now 160 employees and consultants at third quarter end. And of course, our goal is still to continue to develop disruptive solutions for faster infectious disease diagnostics.We'll talk about the first product that is now in the market, and that's targeting bloodstream infections and/or sepsis, of course. You can also see some key highlights from early this year where we achieved the CE Mark in May. And also, we could see during the evaluation of ASTar in commercial terms, performed by Thermo Fisher during the summer, we had a very strong result from that. And we'll not be able to present the details of it that will come into a future presentation, but we are very happy where we are right now. And also as well for the portable culturing technology, where we're now in the phase to select contract manufacturers to really take that to product level quality of that product.But if we go to the next Slide #4, just a high-level summary on the first indication, sepsis. This is truly a global health crisis and time to correct treatment is critical to patient outcome. When we look at the world today with sepsis, we have around 50 million affected every year. And we have a person that will die somewhere in the world every third second from sepsis. So this is a huge problem and sepsis is, of course, when our own immune system overreact to infection somewhere in the body. It can be a skin wound, it can be a lung infection, bacteria leak out into the blood stream and then the immune system can cause a dramatic reaction that can progress from sepsis to septic shock, eventually shutting down organs and could, of course, potentially lead to death.But if we look at Slide #5, here we put some of the key topics of sepsis on your left where we can say it's a leading cause of death in the U.S. hospitals. It's the #1 cost driver in the U.S. health care system. But it's also important to note is that when you start treating patients for sepsis, you start with broad spectrum antibiotics. And you do that, of course, without knowing if the patient will progress into sepsis or septic shock. And this basically leads to around 50% of all treatments are inappropriate. That was even worse is that around 20% of the patients will actually die before you get the correct treatment recommendation. And this is really our focus for us to our first product to help provide a better care for patients with severe infections and, of course, make them come back to normalize faster.To your right, you can also see the second problem, antimicrobial resistance. It has been presented as the biggest threat to mankind. So why is that so? Well, as you know, since the 50s really when we started using antibiotics, we have seen a dramatic increase in all-white survival from infections and overall, of course, age for people in the world today. But from the day 1, we started using antibiotics. Bacteria start to generate resistance towards the various drugs we have on the market. And this is something that needs to change. And it's to continue in the lower part of the image.I mean, in 2016, around 700,000 people died from infections where we don't have an antibiotic to treat the infection with. And that number is estimated to go up to around 10 million in just 30 years. So of course, what we need to do is provide better tune to the health care providers to be able to select antibiotic when it is appropriate and select the most narrow spectrum antibiotic to really reduce antimicrobial resistance. So I would say that the product and our mission and vision in the company is really to help fight both infections today, but also for future generations.If we then move into Slide #6. It just provides an overview of the difference of the current traditional diagnostic workflow for septic patients on the upper part compared to the workflow if you implement an ASTar system. And on a high level, of course, what you can see, you dramatically reduce time before you get optimized therapy. So you can also see that every great circle here in both the top and bottom part of the image represent a step that you need to perform in the lab with the personnel you have in the lab. You can see that the traditional diagnostic workflow includes many, many steps over the course of several days. And this is, of course, causing a lot of time taking decisions for the staff. It also means that you have had quite a high number of staff able to do this rapidly. While if you focus on the lower part, you can see that the time to optimize therapy is faster and the number of steps required by the staff is also dramatically reduced, and I'll come back to a number of these key steps.I think also when we talk to time to therapy, you have to link the susceptibility result with an identity result, meaning what bacteria is causing the disease and what antibiotics are used to treat it with. And ASTar has provided a very broad platform in generating a broad number of answers. So that means that we look at many antibiotics or antimicrobials. And by doing so, you can actually start by identity analysis and the susceptibility test at the same time. If you have a limited panel then, I would say that most customers would have to wait for the ID results to complete and then choose the appropriate panel. Of course, you are wasting a lot of time in the diagnostic workflow. So the broad panel really enables you to be rapid to actionable results.If we move to Slide #7. This is just a summary of 3 independent health economic studies that have looked into what could the potential benefits be if you can be 24 hours faster compared to current standard practice. And there are quite dramatic effects summarized here. From left to right, low mortality and quite dramatic difference in reduction in mortality and, of course, being that more patients will survive and come back to normal life. But also, if you have the correct treatment faster, you can also reduce the overuse of antimicrobials. And that means also that you reduce the superinfections that you see in the hospital and that are on the rise worldwide.I think for the furthest right, the money cost saving for the hospital is really that these studies could indicate that you can save, on average, 2 days in the intensive care unit. And as you know, an intensive care unit, there you have the patients around the buy, a wealth of staff from the hospital trying to keep the patient alive. Of course, these are the most expensive beds, and we have seen during the pandemic that we also have too few of these beds. So by reducing the time at the ICU department, you can also get the patients, of course, out to a normal life faster. You can save a lot of money at the hospital and you can free up capacity. So ASTar, when we compare, it could be around 24 to 40 hours faster. So of course, we're now planning our own health economic studies to start next year to also see what the benefit ASTar could bring for these various categories.If we now move into Slide #8. It's just a high-level summary of the 4 pillars that has been the foundation for ASTar development. And these pillars have really been selected and developed together with our customers, Europe and U.S. to understand what's the most important for you and how can we really make your life better and also the life for the patient better.And number one, that we see here is that it needs to be easy to use. So full automation is a key, we think, very little hands-on time. And this really means that you can start the test at any given time point. It needs to be fast, so from A to B, it takes around 6 hours to have a complete result. We also have a high throughput in the system. But we also need to be comprehensive. The drive to be comprehensive is really to be able to have actionable results for as many patients as possible. If you have a smaller coverage or smaller panel, you might need to do follow-up testing using the traditional methods in the hospital, and that can take 1 or 2 days more. And of course, not only could that be detrimental to the patient, it also reduces the value of the rapid test.So I think for us, it's been really important to have a large coverage of various bacteria and various antibiotics. And then, of course, we need to provide the correct answer, it needs to be accurate. And the MIC value is the value that determines what concentration of antibiotic will kill or inhibit bacterial growth, and we provide the true MIC value with a very high reproducibility. So now these, of course, were the growth in development. Now the product is launched, we can reflect on how well we have accomplished those goals so far.So moving to Slide #9. We can start with the ease of use. And here, it -- really the goal is that anyone should be able to use a test at any given time point and to do so in less time. And here, we have received very positive feedback from early testers of the system either during the clinical study or now during commercial valuation to see that it really is simple to use ASTar. And you can really train anyone in the lab to run the system in around 15 minutes. So we also have some strong testimonials that commit to ease of use. So I think there, we have a great deal and very long way of including everyone to run an ASTar.If we move to Page #10, we look at the comprehensiveness of the panel. This is just a summary of what we have presented earlier, the results from the clinical study in Europe, where we had very high quality of data with regard to essential agreement, meaning that we are equal to the reference, categorical agreement, meaning that we provide the correct treatment recommendations, the sensitive intermediate resistance and also very high reproducibility. Of course, the value has exceeded what's required to launch in Europe, also well exceeded with what FDA would expect from the U.S. study.And to the right, you can see that when we compare our coverage, when we look at the number of antibiotics and the concentration ranges that we cover, we compare that with the 2 other companies that today provide a fully automated solution, we can see that ASTar clearly provides a broader coverage, meaning, in our words, it can make more actionable results to many more patients and, of course, this is important.If we then move to Slide #11, this is the throughput of the system. So one thing in ASTar turn lights up to 12 patients in parallel. The loading is random access. So if you have free capacity, you can easily load a sample, but also our consumables enables you to do the fully automatic test as for sepsis. But we can also look at semiautomatic test, for instance, islets where we only can consume the CD. So that means that we are very flexible for the future. And the cart has also been designed to handle large sample volumes, which is needed for urine samples, for instance. We also see that our consumables can be stored in room temperature. We just have a small, small insert, a couple of cubic centimeters that needs to be stored in the freezer. So also it's easy for the lab to accommodate the storage of our consumables.If we then move into Slide #12, we will move into the key highlights of the third quarter. And as I said, it was really a lot of preparation in that quarter for the upcoming launch and during the U.S. study. I think one of the biggest activity we performed during the quarter was an activity run by Thermo Fisher Scientific, and that was a commercial evaluation of the system. So several sites in Europe has been selected to really pressure test the system, provide their feedback. And of course, all results were compared to the reference measurements and also in-house methods.As of today, we cannot provide the study results. But what we can say is that it really performed with excellence in all key aspects. System stability was very, very high. The performance and the customer feedback was very, very good. So I really look forward to be able to present the results from this study. But I think it also made us feel very confident in that we have built a product that really supports the customary making good decisions for this patient group.If we then move into Slide #13. We have, of course, also continued development of the portable culture device. We have now many, many prototypes extensively tested during the quarter. As we mentioned before, the average time to positivity is around 1 hour faster than the current cabinet. But then, of course, we also utilized all the time in transportation. We are now moving in the next sort of phase with this product, and that's a discussion with contract manufacturers who will then actually produce the units. So transfer it for manufacturability. We have very good strong suppliers that has presented interest, and we are moving now into selection phase. We also completed a U.S. customer valuation. We had 23 hospital evaluating the value proposition, so to speak. And we have also a very strong feedback received with a clear value for the patient. So I think our portable culturing technology has progressed exactly according to expectations during the quarter.If we now move into Slide #14, I would like to mention a couple of very key events just after the period end. One thing that we can announce is that we're now moving to the next phase for the study for the U.S., but that was to start the reproducibility study. We run that at 3 Swedish sites, and it's also progressing very, very well. And of course, sort of the last leg of the U.S. clinical study is to start the prospective part, meaning testing on patients. And we are very close to announce we're coming to that stage as well. So we also see some great progress in the clinical study for the U.S. market.And lastly, here on Slide #15, of course, something that I would say we have all waited for. I hope you as well as me. And I want to see that Thermo Fisher Scientific launched ASTar in Europe on October 7. So I think this is, of course, a lot of work and a lot of preparation to come to this point. And we are super happy to see the product now is becoming available to our audience.And also just a couple of days after, we could also announce that we signed our first valuation contract in Sweden. As you know, Sweden is not a big market for this, but we think it's important to also keep close to our home turf, so to speak. So if you want to follow here a bit more, we have a link on Thermo Fisher press release, and there are much more information also on the web page around ASTar with some nice material.So to conclude my part, we got Slide #16, and that still talk about the effects of the corona pandemic. As you know, we are moving more or less back to normal, but it is not over yet. And some of the effects of the pandemics are still over us. I think our conclusion in retrospect is that Q-linea, as a company, and all its personnel has managed the pandemic in a good way. We have not identified any spread within the company. We have had very rapid follow-up in chest infection to really minimize future spreading, but we've also assisted in helping university hospital performing COVID testing.So I think so far, we have done a good job and try to help out. Of course, as I said, it's not over. And you all know this. We see some possible effects in the future. Of course, we can still see a risk in the U.S. clinical study time line, depending on if we see a new outbreak or something else happens in the U.S. But so far, we think it's manageable and according to our expectations. You have also seen that there's a lack of components all over the world really. And this is something that could truly hit us as well during next year. We say, so far, we have planned for long-term orders and have ordered a lot of components to minimize the problem. But again, it all depends on how long this shortage may persist, so to speak.So overall, when you look at it, we might see expense levels and financing strategy linked to the various delays. But I would say, overall, I think we are in a good position, and we are really trying to tackle the possible problems we might face in the future. We will still, of course, follow the development very carefully and really see if we see any changes, that means that we need to do any sort of mitigation. And I can just urge everyone that has not yet vaccinated, please become vaccinated. I think that's a very important step for yourself and for mankind as such.And with that, I will conclude my part of the presentation. I will now hand over to Anders Lundin, our CFO, to make a comment on the financial outcome from the quarter. Welcome.

[Anders Lundin, Chief Financial Officer]

Thank you, Jonas. So I will have a couple of slides with the financial numbers that we reported out this morning. To summarize the quarter from a financial perspective, it is a quarter without surprises. So I will start my presentation on Slide 17.So we reported the net sales in the third quarter of SEK 1.1 million with a cost of goods of minus SEK 3.1 million, giving us a gross margin of minus SEK 2 million. We had an operating result, which was in line with the same quarter last year of minus SEK 50 million. And we had a loss after tax also in line with last year SEK 49.1 million compared to SEK 48.7 million last year's quarter 3. That gave us an earnings per share before and after dilution was minus SEK 1.68 compared to minus SEK 1.8 last year.So then if I move into the Slide 18, we have some lines here on the balance sheet, end of the third quarter. So in the cash and cash equivalents, bank accounts, we have SEK 21.6 million. And we have invested -- we did rights issue in -- directed issue in June this year. So we have placed those surplus liquidity into short-term investment funds, it's interest funds. So we had SEK 181 million in those funds by quarter end. And we have also portion of listed bonds, which are due within 12 months from the reporting. So that is SEK 26.3 million. Then we have listed bonds of total SEK 215.4 million. So -- and another thing is the inventory which we have SEK 23.4 million in our warehouse. And that includes a write-off of minus SEK 2.7 million in the quarter end.So then if I move into the Slide 19. We had a cash flow of operating activities of minus SEK 63 million compared to minus SEK 46.7 million, same quarter last year. And that was mainly the increase in the cash flow or the outflow was mainly due to working capital comparison over the last year. And then we have investing activity. We have been -- divest short-term funds to use it in the operations to -- and lastly, we had a very small portion of minus SEK 53,000, as a financing activity, and that is basically repayment of loans.And if we summarize the available assets that we can use for the operations. That is -- by the end of the quarter, we had SEK 444.5 million that are easily accessible for us. And the Board's assessment is that we have working capital that is sufficient for the company to operate for at least the next 12 months.So that concludes my part of the presentation. So I hand over to Jonas again.

[Jonas Jarvius, CEO & President]

So thank you very much, Anders. We can just move to Page #20 or Slide #20 to really conclude our part of the third quarter presentation. And we really, as a company, want to contribute to help their society, and by doing -- future-proofing new generations. So with that, we'll conclude our presentation and open up for any questions. Thank you very much.

[Operator]

[Operator Instructions] We have a first question from Victor Trattner (sic) [ Ulrik Trattner ] from Carnegie.

[Ulrik Trattner, Research Analyst]

I do believe it's Ulrik Trattner. Hi, Jonas and Anders. A few questions on my end. You mentioned in your CEO wording "extremely", I do believe, you call it extremely excellent feedback from this customer evaluation. If you could elaborate on what that actually means as well as if you can provide us with how many has it been part of this initial commercial evaluation phase?

[Jonas Jarvius, CEO & President]

Okay. Thank you very much, Ulrik. Yes, I can't provide the exact details because, of course, that's going to be published. But of course, what we do look here is there are numerous sites in Europe, and we will, of course, present that in more detail. The size of the valuation has been comparable, I would say, on the size for the European clinical study. So there's been a high number of samples being tested. And when I say extremely happy, I really mean extremely happy. As when we look at the performance from essential agreement as compared to the reference, it's a very strong result.When we look at the number of samples that you actually put into an ASTar that you could actually provide actual results from, I mean, make a treatment recommendation, it was also very, very high. I mean, as we perhaps have discussed before, our goal has been to be above 95%. I mean, so to be able to make a treatment recommendation. It was, let's say, higher than that, so very, very good.Of course, one thing that also has been important is to really pressure test the system, having it installed and see how does it perform? How stable is it? And also in that aspect, I would say that the system clearly delivered stable and strong results. So I would be very happy to announce them. But on all the key aspects to me, when you look at the performance of the system, it has been very, very good.Of course, one of the most important part is also feedback from the collaborators that tried ASTar and used it, and that feedback was also very, very positive. Again, super simple to use. And what makes me really happy is when you get this type of comments that a person will realize that if I have this system in my lab, I can truly make different treatment decisions. And I think that link is very strong. So phrasing it "extremely happy" is correctly, exactly right in this regard.

[Ulrik Trattner, Research Analyst]

Great to hear. And could you give us some teaser in terms of utilization rates? How many tests have been performed on a daily basis?

[Jonas Jarvius, CEO & President]

I probably can say that for defibrillation, it was around 5 tests a day or so.

[Ulrik Trattner, Research Analyst]

So roughly a 50% utilization rate for the general European microbiology lab in a large hospital.

[Jonas Jarvius, CEO & President]

Yes, I would say so. Depending on the size of lab, I think, that would be more or less true. I think also the sites here were really selected to cover sort of the various type of hospitals that you can see from 24/7, meaning, of course, larger to more extended day shifts. And of course, the reason for that type of strategies try to look at the various type of customers that you want to address in the next stage.

[Ulrik Trattner, Research Analyst]

Great. And as you mentioned, next stage in terms of commercially launched, what does that entail in terms of how many markets will it be rolled out into how wide do Thermo Fisher want to go here initially?

[Jonas Jarvius, CEO & President]

Yes. Of course, I mean I cannot really provide the answer for Thermo Fisher in this case. Of course, we are very much in line and have detailed discussions. But we can't really provide you with that answer in this call. What I would say is, of course, a natural thing when you now have a CE Mark is what you typically do is you put more focus on the perhaps key markets in Europe. And that's why you put your first initial sort of pressure on. But of course, any -- within any market where we now have approval, if you are interested in ASTar, you can, of course, always reach back to Thermo Fisher and they will respond. They have presence throughout Europe. But I think the launch will be that we will focus on the key markets. And of course, it's really up to Thermo Fisher to decide the exact strategies, but that would be the sort of the general rollout as I see it.

[Ulrik Trattner, Research Analyst]

Okay. Great. And we have touched upon this before in our discussions. But how will you be able to interact with the end customer, given that Thermo Fisher is your partner, will you have a good insight into this installed base and the end customer usage?

[Jonas Jarvius, CEO & President]

Of course, we do. I mean, of course, first of all, we have regular follow-ups, looking at how it's progressing. But then also, as we mentioned before, I think the partnership we have is truly unique. We have full access to the customers that Thermo Fisher meet with and eventually install an ASTar. So it's really a way when I see that the Thermo Fisher as per customer base increase, our customer base increase at the same rate. So we really have full access to that. I think it's absolutely important, of course, to really understand what we can do to make the product even better, but also what should be our next product or panel in development. So I think this is an absolute key in our partnership. And it's -- as I mentioned before, it's not a very usual type arrangement. But to us, this was really an absolute must time for the partnership. So we have regular catch-up and we have a lot of possible interactions with our future customers.

[Ulrik Trattner, Research Analyst]

Great. And on to the U.S. study with expected finalization towards the end of the year, I would assume that would be regarding the prospective part. Any risk that you see that FDA have a backlog would delay the 510(k) process beyond the common 90 days as well. Are you happy with using free hospitals for the prospective part? Or would you like that to be expanded further?

[Jonas Jarvius, CEO & President]

No, I don't think we want to expand to further hospitals. I think there, we are quite satisfied. And of course, our next step is to be able to communicate when we start really enrolling patients. So there, I think we are in a good position. Regarding FDA time lines, as you know, it's extremely difficult to predict their approval time lines right now. It has been a stressful environment for them. We do know that they don't accept new presubmission inquiries. So I think for any company that wants to come to the U.S. and have questions about that, they will not be accepted right now. They're really focusing on what's really in the pipeline today. And rapid AST is one of the priority areas.So I think there, we will not be able to provide perhaps some more detail on when we come into that phase. But I think we, as a company, need to focus now on progressing well in the study and, of course, generate the same high-quality results that we did in Europe, and we do anticipate to do so and, of course, try to have such an extensive filing to really minimize follow-up questions. But we, of course, as you remember, we had the presubmission inquiry. We then have the pre-sub supplement with long discussions with the FDA to align and agree on the study design. So I think in that regard, we sort of hit that precisely before the pandemic. And I think that's really important for a successful outcome of the study.

[Ulrik Trattner, Research Analyst]

Great. So sort of a big picture question, perhaps. We previously talked about the transport device, obviously, intriguing, expecting to enter pivotal trials towards the end of the year. I would guess that's dependent on semiconductor shortage. But if you were to put the transportation device aside, how about panel extension, how is that going along? And what is your strategy to move here going forward to expand test assays perhaps initially to urine?

[Jonas Jarvius, CEO & President]

Right. So I think there were a number of stages. I mean, first of all, what we do emphasize is, as you know, we have today the broadest panel with a number of antibiotics and concentration ranges for the already launched product. But already there, we would like to increase coverage. We -- our goal is really to make as many patients providing actual results. So I think we're also looking at expansions there to really make it even more complete in a sense. So that's an obvious thing that we are working with. Of course, also moving towards gram-positive.And then when we look at other indications, we have discussed islets and, of course, urine might be also a test. And there, we are, of course, I would say, still a little bit in decision-making on what really would be the next development for ASTar. And we haven't presented an exact idea. I think we are gravitating towards islets. We have really seen that -- the coverage of our system also actually provides a very good islet product. So maybe we have put that up a little bit higher in the priority compared to the urine. So I would suspect if you ask me today that, that would be the order we think about product development. And of course, that's a long-term strategy for the company to really be able to be complete from A to Z in all types of testing.

[Ulrik Trattner, Research Analyst]

Great. Well that was all question on my end for today. Thank you very much and congratulations on the good progress during the quarter.

[David T. Lougee, President, CEO & Director]

Thank you very much, Ulrik. Thank you very much.

[Operator]

Next question from Adam Karlsson from ABG.

[Adam Karlsson, Research Analyst]

Hi, Jonas, Anders. A couple of questions from my side, if I could. Perhaps just first on the U.S. approval and subsequent commercial launch, it was discussed in the previous set of questions. The time line for approval, obviously, slightly up given the pandemic, but I was wondering if you could give any thoughts on the kind of the lag between potential approval and then the commercial launch by Thermo Fisher. There was, obviously, a bit of a lag between the CE-ivd marketing and the official European launch by Thermo Fisher. Are we to expect a similar kind of live periods in between approval and commercial launch? Or how should we think about that?

[Jonas Jarvius, CEO & President]

Okay, Adam. No, thanks. I think that's a good question. First of all, the answer is no. I don't think so. I think in this case, the European launch was really the first big launch of ASTar. And I think, as we described there, we wanted really to make that control to be able to press start the system and really make sure that we are all in alignment with the performance, the expectations of the product before Thermo Fisher goes broader. So I think in that sense, that was the right strategy, but it was also sort of a onetime strategy. One should also remember that when we come into the U.S., we will have a lot of data points from Europe. And really, the system is the same in the U.S., we just report according to different guidelines. So I don't see that.I think on the other hand, we are rather thinking a little bit more aggressively there is, of course, now we are into -- moving into the prospective part of the study. And really, the question is also what type of studies could you do pre-commercially in the U.S., for instance, while FDA is considering the clearance. And before we have that, I mean we have a number of instruments on the ground in the U.S. And of course, we are trying to think together with Thermo Fisher, are there any good pre-commercial activities that you can actually use that time before approval. So I don't expect to see that pattern as we saw for Europe. That was really I mean, the first launch and we wanted to make sure that it meet all requirements. So I think we'll try and start to use the time waiting for clearance in the best possible way.

[Adam Karlsson, Research Analyst]

Okay. Great. Thank you. And a question on your plans. I know it's been discussed previously in terms of reporting, sales KPIs going forward now that the launch has begun in earnest in Europe. Can you guide at all what we might expect to hear in terms of systems placed in utilization and so on and if not in the next quarter and in the quarters to come?

[Jonas Jarvius, CEO & President]

Right. So I think that's also a good question. I mean what we have thought is, I mean, of course, we're going to be as transparent as possible going forward. I think what we have said is we really would like to see sort of the first launch period, maybe the first year to see if the traction. You know that any launch will take some time to pick up before you get the stability and the lead time generation and so on. So I would like to say that for the next couple of quarters, we will report, of course, at every quarter end, how we see the market growing and developing, before we move into that more of sort of anticipation for the future to come. And I think that's really -- to be fair and honest, to really be able to follow the quarters and report that out before we start to make expectations. So I think that's the right thing to do as a company, and I think it's also the best for the market. But of course, eventually, we will come into a different situation where I look very, very positive on the future for ASTar and when we see the demand and reaction so far, I think we are in a good place.

[Adam Karlsson, Research Analyst]

Okay. Okay. Perfect. And a question, has Thermo placed any commercial systems in Europe so far, I guess, since -- I guess I'm asking specifically kind of systems beyond this initial choreograph launch of kind of selected labs that you've had since the CE-ivd approval?

[Jonas Jarvius, CEO & President]

Sorry, I can't comment on that today. I think we actually have to wait. And that's -- the comment is really that we think that Thermo Fisher also have to jointly decide on exactly what we, as a company, can or should communicate and what they, as a company can and should communicate. So there, we are still sort of in discussions to make it most transparent to, of course, our shareholders, but also, of course, follow the guidelines from a larger company. So I can't give you any specifics today, Adam, I'm sorry. But hopefully, that will change for the year-end report.

[Adam Karlsson, Research Analyst]

Fair enough. Okay. A question on costs. We saw personnel costs down quite substantially quarter-over-quarter, and yet you seem to be adding more staff, is this a switch from more consultants to more full-time or permanent employees? Or how should we understand that? And is the -- and is this kind of the personnel cost that we saw this quarter? Could it be more representative of what we can expect in quarters to come? Or any color on that would be appreciated.

[Jonas Jarvius, CEO & President]

So what I can say overall, I mean, we have, of course, consultants in specific areas we have been doing. So we are -- we're moving, building the organization also for the future where we would like to rebalance a little bit, the number of consultants versus employees and particularly in some areas where we want to move into more personnel. So that might be one of the parts.Looking at growth going forward, I mean, without giving any specifics, you do know we invest in scale up for manufacturing. Of course, we see a great future for our product. So of course, in production and those related areas, we anticipate to see a growth coming up according to volume. So that would be sort of my high-level comment on that.

[Operator]

Next question from Jonas Amnesten from Redeye.

[Jonas Amnesten, Former Equity Analyst]

Yes, I have a few. And first, with the test panel, you are in the process of expanding this further. Can you give us any feel for what to expect there, a gradual expansion? Or should we expect a bit of a leap. You already have a very broad panel.

[Jonas Jarvius, CEO & President]

Yes. So thank you, Jonas. I think it's a good question. I think to make at least now would mean that our panel will be extremely broad, which is in a way already. So I would see sort of a gradual improvement of that. And of course, the reason is, I mean, the way we planned our clinical studies is to be able to do these type of increases of the panel coverage. And really, I mean, some companies could argue that with the panel we have today that's not really needed. That's not the way we look at it. We really look at every individual patient has a need. And even if you have a very specific resistance mechanism, we would like to cover that. Of course, it can never be 100%. We know that. But we try to see what makes sense in trying to expand the panel, but also, of course, trying to make these panels available to our customers. So this is going to be a continuous work, and I think it will sort of never end. I hope it will never end because they're also coming new antibiotics to the market. But I think you can see some very positive developments on the panel in the future.

[Jonas Amnesten, Former Equity Analyst]

Thank you. That's useful. I also believe you touched upon that you are in the process of improving lead time to results as well. Is that a similar dynamic?

[Jonas Jarvius, CEO & President]

Yes. So what we did, what we have presented on key contracts this year. I mean, as you know, we have always said the time to result for ASTar is a 6-hour result time. This does not mean that some drugs are a lot faster. It really couples to the dynamics from the bacteria and the antibiotic. So what we did present was really in 3 hours' time, we can identify resistance in a lot of these key pathogens. So I think what we're doing right now, we can -- we have clearly demonstrated that the capacity is already built into ASTar.And then, of course, it's a judgment call. One is this the correct time line to bring it to the product. How should we link that to the market. So I think a lot of these -- these are all good and I would say, positive developments that we see in the future. And now it's really to see what will be the best timing of these future releases. So I will not give any time line yet, but I think also it was important to demonstrate that, in my view, we have only scrapped the surface of what ASTar can perform. We have some many interesting things that ASTar can do but we haven't sort of included that in the value proposition of the product today. And I think that is also sort of our long-term plan to be able to come with new additions to the market and also, of course, follow the market needs. So I really see an interesting development of the ASTar system itself, not just looking at other indications.

[Jonas Amnesten, Former Equity Analyst]

Yes. Thank you. And you went through some evaluation feedback. One question is when can we expect some results from the evaluations and a clarification. You mentioned that probably about 95% of the tests or patient tests as they can give a result, from; which is, at least in our book, extremely good result. Could you just clarify that this is, of course, a blood-based sepsis bacteria, and it's qualified to be growth? And the grand status is clarified more of these tests, ASTar can resolve more than 95% of the cases.

[Jonas Jarvius, CEO & President]

Right. So I mean, our goal has been to be above 95% of everything that you put into ASTar that it should be able to sort of analyze. And of course, where we are right now, so far, it looks like we can be even better than that. So we are really happy about that. The exact timing, honestly, I can't provide that. I really would like to see that coming out during the fourth quarter. Of course, it needs to be coordinated to be able to provide these results.I think when I look at it, and what I see is that all the efforts we have put in together with customers on what's really the most valuable aspect of this type of system and test, I feel that we have really ticked and delivered on the promise there. So I would clearly not wait a second to release these results as soon as we can do it. But I think we are really in a good place. And I think also now that, one, we can truly demonstrate that value commercially, not just in a clinical study, I think that really is an important step in our company development and the commercial development of the product.

[Jonas Amnesten, Former Equity Analyst]

Yes. And the U.S. study, you're going to do the prospective part pretty soon. Could you remind us it's around 450 samples, what proportion comes from new blood samples and is the Delta impact the risk in this prospective?

[Jonas Jarvius, CEO & President]

Yes, so right. I mean that's roughly the size we see from the prospective part of the study. I mean if we look at the overall number of tests in the U.S. study, we are talking about 7,000 tests. I mean, we primarily stands for most of these tests. So I would say, I mean, when you look at the risk base, I mean -- to me, the obvious question is the U.S. population very different than European population regarding the various types of bacteria resistance pattern I see. I would say the answer is no. You see more assistance in the U.S., that's for sure. But of course, when we tested our product for the European region, we, of course, used a lot of resistant bacteria that was added to the test to really press the test sort of the most difficult sample. So to be honest, I really don't see any sort of added risk of ASTar not performing in the U.S. versus Europe from a bacteria antibiotic standpoint.

[Jonas Amnesten, Former Equity Analyst]

And the impact from Delta, the COVID, is not a major concern for the timing?

[Jonas Jarvius, CEO & President]

No. I mean -- so as we described, I mean, there's -- COVID is not over yet. And particularly, I would say in the U.S., it hasn't been over. But I mean as we said, moving into the prospective part what we have seen, at least, in Europe is that even when we're in the middle of the pandemic, the inclusion of samples in ASTar went perfectly well. I mean it's a high priority sample. ASTar is really simple to use. So I think all the prerequisites are there to see minimize effect of that during testing. So of course, I can't say anything about it yet because it hasn't started. But I really don't expect us to see a very different pattern in U.S. versus Europe on that regard. And I might be wrong, but I really have not seen anything that would post that at a higher risk as of today.

[Jonas Amnesten, Former Equity Analyst]

Great. And finally, ultrafast ASP testing is still in the building up, is still in early stage market, which is both, of course, a big opportunity and a bit of a challenge. You're now in launch, now what's your reflection on this aspect compared with, let's say, 1 or 2 years ago?

[Jonas Jarvius, CEO & President]

I think the world is sort of in a better place in the sense that Accelerate, I think, has done a good job sort of educating the market also showing health economic that it adds value to the market. So I think that people are much more aware about it now. And it's very clear, I think when we talk to customers, and of course, from Thermo Fisher perspective is that the need is 100% here now. People see the need for these type of tests. They understand the value of these tests. So I think timing wise, for the world, it would have been better if we were all on to the market 10 years ago. We're not. We are more or less here now. But I think timing-wise, it is right. And you are right, it's a new field still. So I still think that getting sort of the massive adoption that we would like to see over years to come. It will take some time. I mean it will be key opinion leaders, early adopters that will drive any new market development in my sense, and that's the way it will look like in our field as well as in others.So I think looking at the feedback we have seen so far, it feels very good. And then, of course, it will see how fast can that be then converted to commercial testing of ASTar and putting it into everyday practice. And that's really, as you say, the big next step to provide the proof really that, that is going to happen with our system as well.

[Operator]

Thank you. We don't have any more questions for the moment. [Operator Instructions] We have no more questions. Back to you for the conclusion.

[Jonas Jarvius, CEO & President]

Thank you very much. So by that, me and Anders would like to conclude our presentation for the third quarter of 2021. And of course, we are truly excited now for the next quarters to come and really see ASTar peaking up commercially. And we, as a company, really taking the next step. So with that, I would like to say thank you, everyone, and thanks for the good questions. Have a nice day and always stay safe.

[Operator]

Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation. You may now disconnect your lines.