Welcome to Q-linea audiocast with conference Q3 2021. Today, I am pleased to present CEO Jonas Jarvius and CFO Anders Lundin. For the first part of this call, all participants will be in listen-only mode, and afterwards, there will be a question and answer session. Speakers, please begin.
Thank you very much for that, and welcome everyone to our presentation for the third quarter of 2021. Q-linea, we're working hard to future-proof healthcare, to make it sustainable for new generation. If we go into the presentation, we go to slide 2. Here, we show our disclaimer slide in case I or Anders will make any forward-looking statements during the presentation.
Having said 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 1/4 as really been a preparation 1/4. It's been preparation for the commercial launch together with Thermo Fisher that happened just after the period, and 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. Apart from that, we have been growing the company according to plan. We're now 160 employees and consultants at third quarter end. 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 on 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. We could see during an evaluation of ASTAR on commercial terms performed by Thermo Fisher during the summer, we had a very strong result from that. I will not be able to present the details of it. That will come into a future presentation.
We are very happy where we are right now. Also as well for the portable blood culture technology, where we're now in the phase to select contract manufacturers to really take that to product level, quality of that product. If you go to the next slide, number four, 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 1/3 second from sepsis. 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 bloodstream, 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. If you look at slide number 5, here we put some of the key topics of sepsis on your left, where we can say the leading cause of death in the U.S. hospitals.
It's the number one cost driver in the U.S. healthcare system. It's also important to notice 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. This basically leads that to around 50% of all treatments are inappropriate.
What's even worse is that around 20% of the patients will actually die before you get the correct treatment recommendation. This is really our focus for ASTAR first product, to help provide better care for patients with severe infections and of course, make them come back to normal life faster. To your right, you can also see the second problem, antimicrobial resistance. It has been presented as the biggest threat to mankind. Why is that so?
Well, as you know, since the 1950s really when we started using antibiotics, we have seen a dramatic increase in overall survival from infections and an overall, of course, age for people in the world today. From the day one when we started using antibiotics, bacteria start to generate resistance towards the various drugs we have on the market.
This is something that need to change. As you can see on 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. That number is estimated to go up to around 10 million in just 30 years. Of course, what we need to do is provide better tools to the healthcare providers to be able to select antibiotic when it is appropriate and select the most narrow-spectrum antibiotic to really reduce antimicrobial resistance. 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 number 6, it just provides an overview of the difference of a current traditional diagnostic workflow for septic patients on the upper part compared to the workflow if you implement an ASTAR system. On a high level, of course, what you can see, you dramatically reduce time before you get optimized therapy.
You can also see that every gray circle here in both the top and bottom part of the image represent the 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 steps over the course of several days. This is, of course, causing a lot of time-critical decisions for the staff.
It also means that you have to have quite a high number of staff enabled 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. 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 antibiotic should you use to treat it with. ASTAR has provided a very broad, platform in generating a broad number of answers. That means that we look at many antibiotics or antimicrobials, and by doing so, you can actually start 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, then you are wasting a lot of time in the diagnostic workflow. A broad panel really enables you to be rapid to action the results. If we move to slide number 7,
This is just a summary of 3 independent health economic studies that had looked into what could the potential benefits be if you can be 24 hours faster compared to current standard practice. 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.
Also, if you have the correct treatment faster, you can also reduce the overuse of antimicrobials, and that means also that you reduce the super infections that you see in the hospital and that are on the rise worldwide. I think to the furthest right, the most dramatic 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.
As you know, an intensive care unit, there you have the patient surrounded by 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.
By reducing the time at the ICU department, you can also get the patient, of course, out to a normal life faster, you could save a lot of money at the hospital, and you can free up capacity. ASTAR, when we compare it, could be around 24-40 hours faster. Of course, we're now planning our own health economic studies to start next year to also see what benefit ASTAR could bring for these various categories.
If we now move into slide number 8, it's just a high-level summary of the 4 pillars that has been the foundation for ASTAR development. 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 to really make your life better and also the life of the patient better.
Number one, that we see here is that it needs to be easy to use. Full automation is the key, we think. Very little hands-on time. This really means that you can start the test at any given time point. It needs to be fast. From A to B, it takes around 6 hours to have the complete result. We also have a high throughput in the system.
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.
Of course, not only could that be detrimental to the patient, it also reduces the value of the rapid test. I think, for us, it's, has been really important to have a large coverage on various bacteria and various antibiotics. Then, of course, we need to provide the correct answer. It needs to be accurate. The MIC value is the value that determines what concentration of antibiotic will kill or inhibit bacterial growth.
We provide the true MIC value with a very high reproducibility. Now, these of course, were the goals in development. Now the product is launched, we can reflect on how well we have accomplished those goals so far. If we move into slide number 9, we can start with ease of use.
Here, really the goal is that anyone should be able to use the test at any given time point and to do so in less time. Here we have received very positive feedback from early testers of the system, either during the clinical study or now during commercial evaluation, to see that it really is simple to use ASTAR.
You can really train anyone in the lab to run the system in around 15 minutes. We also have some strong testimonials that commit to ease of use. I think there we have come 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 values exceeded what's required to launch in Europe, also well exceeded what FDA would expect from the US study. 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, and we compare that with the 2 other companies that today provide a fully automated solution, we can see that ASTAR clearly provides the broader coverage.
Meaning, in our words, that you can make more accurate results to many more patients. Of course, this is important. If we then move to slide number 11, this is the throughput of the system. One thing in ASTAR can analyze up to 12 patients in parallel. The loading is random access, so if you have free capacity, you can easily load a sample.
Our consumables enables you to do the fully automatic test, as for sepsis. We can also look at semi-automatic test for instance, isolates, where we only can consume the CD. That means that we are very flexible for the future, and the cartridge 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 at room temperature.
We just have a small insert, a couple of cubic centimeters that needs to be stored in the freezer. It also is easy for the lab to accommodate the storage of our consumables. If we then move into slide number 12, we will move into the key highlights of the third quarter. As I said, it was really a lot of preparation in that 1/4 for the upcoming launch and during the U.S. study.
I think one of the biggest activity performed during the 1/4 was an activity run by Thermo Fisher Scientific, and that was a commercial evaluation of the system. Several sites in Europe has been selected to really pressure test the system, provide their feedback. Of course, all the results were compared to the reference measurements and also in-house methods.
As of today, we cannot provide the study results. 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. I really look forward to be able to present the results from this study. I think it also made us feel very confident in that we have built a product that really supports the customer in making good decisions for this patient group.
If we move into slide number 13, we have, of course, also continued development of the portable culture device. We have now many, many prototypes extensively tested during the 1/4. As we mentioned before, the average time to positivity is around 1 hour faster than the current cabinet.
Of course, you also utilize all the time in transportation. We're now moving in the next sort of phase with this product, and that's discussion with the contract manufacturers who will then actually produce the unit. 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 evaluation. We had 23 hospitals evaluating the value proposition, so to speak. We had also very strong feedback received with a clear value for the patient. I think our portable culture technology has progressed exactly according to expectations during the 1/4. If we then move into slide number 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., and that was to start the reproducibility study. We run that at 3 Swedish sites, and it's also progressing very, very well. Of course, sort of the last leg of the U.S. clinical study is to start the prospective part, meaning testing on patients.
We are very close to announce we're coming to that stage as well. You also see some great progress in the clinical study for the U.S. market. Lastly, here on slide number 15, of course, something that I would say we have all waited for, I hope you as well as me. That was to see that Thermo Fisher Scientific launched ASTAR in Europe on October 7.
I think this is, of course, a lot of work and a lot of preparation to come to this point. We're super happy to see the product now is becoming available to a broader audience. Also, just a couple of days after, we could also announce that we signed our first evaluation contract for 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.
If you want to follow here, read more, we have a link to the Thermo Fisher press release, and there are much more information also on their webpage around ASTAR with some nice material. To conclude my part, we go to slide number 16, and that still talk about the effects of the coronavirus pandemic.
As you know, we are moving more or less back to normal, but it is not over yet. Some of the effects of the pandemic 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 infection tracking to really minimize future spreading.
We've also assisted in helping university hospital in performing COVID testing. I think so far, we have done a good job and tried 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 risk in the U.S. clinical study timeline, depending on if we see a new outbreak or something else happens in the U.S. 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.
I would say so far we have planned for long-term orders and have ordered a lot of components to minimize the problem. Again, it all depends on how long this shortage may persist, so to speak. Overall, when you look at it, we might see expense levels and financing strategy linked to the various delays.
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. 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. 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 1/4. Welcome, Anders.
Thank you, Jonas. I will have a couple of slides with the financial numbers that we reported out this morning. To summarize the 1/4 from a financial perspective, it is a 1/4 without surprises. I will start my presentation on slide 17. We reported the net sales in the third quarter of SEK 1.1 million, with a cost of goods of SEK -3.1 million, giving us a gross margin of SEK -2 million. We had an operating result which was in line with the same 1/4 last year of SEK -50 million. 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 1/4 3.
That gave us an earnings per share before and after dilution on -1.68 compared to -1.8 last year. If I move into the Slide 18, we have some lines here on the balance sheet end of third quarter. In the cash and cash equivalents bank accounts, we have SEK 21.6. We have invested. We did a directed issue in June this year, so we have placed those surplus liquidity into short-term investment funds, it's interest funds. We had SEK 181 million in those funds by 1/4 end. We have also a portion of listed bonds which are due within 12 months from the reporting. That is SEK 26.3 million.
We have listed bonds of total SEK 215.4 million. Another thing is the inventory, which we have SEK 23.4 million in our warehouse, and that includes a write-off of -SEK 2.7 million in the 1/4 end. If I move into the slide 19, we had a cash flow of operating activities of -SEK 63 million compared to -SEK 46.7 million same 1/4 last year. That was mainly the increase in the cash flow or the outflow was mainly due to a working capital comparison over the last year. We have investing activity. We have been divest short-term funds to use it in the operations to.
Lastly, we had a very small portion of -SEK 53,000 as a financing activity, and that is basically repayment of loans. If we summarize, the available assets that we can use for the operations, that is, by the end of the 1/4, we had SEK 444.5 million that are easily accessible for us. 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. That concludes my part of the presentation. I hand over to Jonas again.
Thank you very much, Anders. We can just move to page number 20 or slide number 20 to really conclude our part of the third quarter presentation. We really as a company want to contribute to healthcare society and by doing future-proofing for new generations. With that, we'll conclude our presentation and open up for any questions. Thank you very much.
Thank you, ladies and gentlemen. If you have a question, please press 41 on your telephone keypad. We have first question from Ulrik Trattner from Carnegie. Please go ahead.
Great. Thank you very much. I do believe it's Ulrik Trattner. Hi, Jonas and Anders. A few questions on my end. You mentioned in your CEO wording, quote, unquote, 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.
Okay. Thank you very much, Ulrik. Yeah, I can't provide the exact details because of course, that's gonna be published. But of course, what we do look here is there are numerous sites in Europe, and we'll of course present that in more detail. The size of the evaluation has been comparable, I would say, on the size for the European clinical study.
So it's been a high number of samples being tested. When I say extremely happy, I really mean extremely happy. It's 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 ASTAR that you could actually provide an actual result 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, to be able to make a treatment recommendation. It was, let's say, higher than that. 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. Also from that aspect, I would say that the system clearly delivered a stable, and strong results. I would be very happy to announce them. 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. What makes me really happy is when you get these type of comments that a person will realize that if I have this system in my lab, I can truly make different treatment decisions. I think that link is very strong. Phrasing it extremely happy is correctly exactly right in this regard.
Great to hear. Could you give us some teaser in terms of utilization rates, how many tests have been performed on a daily basis?
I probably can say that, for this evaluation, it was the order of around 5 tests a day or so.
Roughly a 50% utilization rate for the general European microbiology lab in a large hospital.
Yeah, I would say so. Depending on the size of the lab, but 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. Of course, the reason for that type of strategy is try to look at the various type of customers that you want to address in the next stage.
Great. 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?
Yes, of course. I mean, I cannot really provide the answer for Thermo Fisher in that 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 where you put your first initial sort of pressure on.
But of course, 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.
I think the launch will be that we will focus on the key markets. Of course, it's really up to Thermo Fisher to decide the exact strategy. That would be the sort of general rollout as I see it.
Okay, great. We've 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?
Of course, we do. I mean, of course, first of all, we have regular follow-ups, looking at how it's progressing. 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 ASTAR. It's really a way when I see that the
Thermo Fisher ASTAR customer base increase, our customer base increase at the same rate. 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.
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 term to the partnership. We have regular catch up, and we have a lot of possible interactions with our future customers.
Great. 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 and would delay the 510(k) process beyond the common 90 days? As well, are you happy with using 3 hospitals for the prospective part, or would you like that to be expanded further?
No, I don't think we want to expand to further hospitals. I think there we are quite satisfied. Of course, the next step is to be able to communicate when we start really enrolling patients. There, I think we are in a good position. Regarding FDA timelines, as you know, it's extremely difficult to predict their approval timelines right now. It has been a stressful environment for them.
We do know that they don't accept new pre-submission inquiries. I think for any company that want 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.
I think there we will not be able to provide perhaps some more detail on when we come into that phase. 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 as we did in Europe, and we do anticipate to do so. Of course, try to have such an extensive filing to really minimize follow-up questions.
We of course, as you remember, we had the pre-submission inquiry, we then had the pre-sub supplement with long discussions with the FDA to align and agree on the study design. 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.
Great. Sort of a big picture question perhaps. We previously talked about the transport device, obviously intriguing, expecting to enter pivotal trials towards end of the year. I would guess that's dependent on the semiconductor shortage. If you were to put the transportation device aside, how about panel extension? How's that going along, and what is your strategy move here going forward to expand test assays perhaps initially to urine?
Right. I think there are a number of stage. I mean, first of all, what we do emphasize is, as you know, we have today the broadest panel with number of antibiotics and concentration ranges, for the already launched product. Already there, we would like to increase coverage. Our goal is really to make as many patients providing expert results.
I think we're also looking at extensions there to really make it even more complete in a sense. That, that's an obvious thing that we are working with. Of course, also moving towards gram-positive. Then when we look at other indications, we have discussed isolates, and of course, urine might be also a test.
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. We haven't presented an exact idea. I think we are gravitating towards isolates. We have really seen that the coverage of our system also actually provides a very good isolate product. Maybe we have put that up a little bit higher in the priority compared to the urine.
I would suspect if you ask me today, that would be the order we think about product development. 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.
Great. Well, that was all questions on my end for today. Thank you very much, and congratulations on the good progress during the 1/4.
Thank you very much, Ulrik. Thank you very much.
Thank you. Next question from Adam Karlsson from ABG.
Great. Thank you. Hi, Jonas and Ish. 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 timeline for approval obviously slightly up in the air given the pandemic. I was wondering if you could give any thoughts on the kind of lag between potential approval and then commercial launch by Thermo Fisher. There was obviously a bit of a lag between the CE marking and the official European launch by Thermo Fisher.
Are we to expect a similar kind of lag period in between approval and commercial launch, or how should we think about that?
Okay. 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 the ASTAR. I think as we described there, we wanted really to make that controlled to be able to pressure test 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. I think in that sense, that was the right strategy, but it was also sort of a one-time 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 all the same in the U.S. We just report according to different guidelines. I don't see that. I think on the other hand, we're rather thinking a little bit more aggressively. There is, of course, now we are moving into the prospective part of the study.
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're trying to think together with Thermo Fisher, are there any good pre-commercial activities that you can actually use that time before approval.
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 that meets all requirements. I think we'll try instead to use the time waiting for clearance in the best possible way.
Okay, great. Thank you. 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 and utilization and so on, and if not in the next 1/4 and then the quarters to come?
Right. I think that's also a good question. I mean, what we have thought is, I mean, of course, we're gonna 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 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. I would like to say that for the next couple of quarters, we will report, of course, at every 1/4 end how we see the market growing and developing before we move into that more of the sort of anticipation for the future to come.
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. I think that's the right thing to do as a company, and I think it's also the best for the market. Of course, eventually we'll come into a different situation where I look very positive on the future for ASTAR. When we see the demand and reaction so far, I think we're in a good place.
Okay. Okay, perfect. 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 choreographed launch of kind of selected labs that you've had since the CE approval.
Sorry, I can't comment on that today. I think we actually have to wait. The comment is really that we together with Thermo Fisher also have to join to decide on exactly what we as a company can and should communicate and what they as a company can and should communicate. There we are still sort of in discussions to make it more transparent to, of course, our shareholders, but also of course follow the guidelines from a larger company. I can't give you any specifics today, Adam. I'm sorry, but hopefully that will change for the year-end report.
Fair enough. Okay. A question on costs. We saw personnel costs down quite substantially 1/4 over 1/4, 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? Is this kind of the personnel cost that we saw this 1/4 kind of more representative of what we can expect in quarters to come or? Yeah, any comment on that would be appreciated. Thank you.
What I can say overall, I mean, we have, of course, consultants in specific areas. We have been doing so. 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 in particular in some areas where we want to move into more personnel.
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. Of course, in production and those related areas, we anticipate to see a growth coming up according to volume. That would be sort of my high-level comment on that.
Mm-hmm. Mm-hmm. Okay. No, perfect. That was all for me. Thank you.
Thank you very much.
Thank you. Next question from Johan Unnérus from Redeye, sorry. Please go ahead.
Thank you, Johan. Nils here, and thanks for taking my questions. Yeah, I have a few. 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.
Yeah. Thank you, Johan. I think it's a good question. I think to make a leap now would mean that our panel would be extremely broad, which is in a way it already is. 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.
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.
We try to see what makes sense in trying to extend the panel, but also of course, trying to make these panels available to our customers. This is gonna 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. I think you can see some very positive developments on the panel in the future.
Thank you. That's useful. I also believe you touched upon that you are in the process of improving lead times, time to result as well. Is that a similar dynamic?
Yeah. What we did, what we have presented on key conferences this year, I mean, as you know, we have always said the time to results for ASTAR is a 6-hour result time. This does not mean that some bug-drug are a lot faster. It really couples to the dynamics from the bacteria and the antibiotic.
What we did present was really in 3 hours time, we can identify resistance in a lot of these key pathogens. I think what we're doing right now, we have clearly demonstrated that the capacity is already built into ASTAR. Of course, it's a judgment call. One, is this the correct timeline to bring it to the product? How should we link that to the market?
I think a lot of these are all good and I would say positive developments that we see in the future. Now it's really to see what would be the best timing of these future releases. I will not give it a timeline yet, but I think also it was important to demonstrate that, my view, we have only scraped the surface of what ASTAR can perform.
We have so many interesting things that ASTAR can do, but we haven't sort of included that in the value proposition of the product today. 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.
I really see an interesting development of ASTAR system itself, not just looking at other indications.
Yes, thank you. You went through some evaluation feedback. One question is, can we expect some results from the evaluation? A clarification, you mentioned that probably about 95% of the tests or patient tests ASTAR can give a result, which is, at least in our book, extremely good result. Could you just clarify that this is of course blood-based sepsis bacteria, and it's qualified to be growth, and the Gram status is clarified among these tests ASTAR can result more than 95% of the cases.
Right. 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. Of course, where we are right now, so far, it looks like we can be even better than that. 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 1/4. 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 aspects of this type of system and test, I feel that we have really ticked and delivered on the promise there. I will clearly not wait a second to release these results as soon as we can do it. I think we are really in a good place. 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.
Yes. 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 does the Delta impact the risk in this perspective?
Right. I mean, that's roughly the size we see from the perspective, part of the study. I mean, if you look at the overall number of tests in the U.S. study, we're talking about 7,000 tests. I mean, we primarily stands for most of these tests. 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 patterns they see? I would say the answer is no. You see more resistance in the U.S., that's for sure.
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 pressure test sort of the most difficult samples. 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.
The impact from Delta, the COVID, is not a major concern?
No, I mean, so as we described, I mean, 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 were 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 a minimized 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.
I might be wrong, but I really have not seen anything that would pose that as a higher risk, as of today.
Great. Finally, ultra-fast AST testing is still in the buildup. It's still an early-stage market, which is, both of course, a big opportunity and a bit of a challenge. You're now in full launch mode. What's your reflection on this aspect compared with, let's say, one or 2 years ago?
Yeah, 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 how it's economic, that it adds value to the market. 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. I think timing-wise for the world, it would've been better if we were all on the market 10 years ago. We're not, we're more or less here now.
I think timing-wise, it is right. You are right, it's a new field still. 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 could drive any new market development in my sense. That's the way it will look like in our field as well as in others. I think looking at the feedback we have seen so far, it feels very good. Then of course it will see how fast can that be then converted to commercial testing of ASTAR and putting it into everyday practice.
That's really, as you say, the big next step to provide the proof really that is gonna happen with our system as well.
Excellent. Thank you.
Thank you very much.
Thank you. We don't have any more questions for the moment, ladies and gentlemen. If you wish to ask another question, press oh one on your telephone keypad and zero followed by one on your telephone keypad. It seems we do not have any more questions. Ladies and gentlemen, if you wish to ask a new question, press oh one on your telephone keypad. We have no more questions. Back to you for the conclusion.
Thank you very much. By that, me and Anders would like to conclude our presentation for the third quarter of 2021. Of course, we are truly excited now for the next quarters to come and really see ASTAR picking up commercially and we as a company really taking the next step. With that, I would like to say thank you, everyone, and thanks for the good questions. Have a nice day and always stay safe.
Ladies and gentlemen, this concludes today's conference call. Thank you all for your participation. You may now disconnect the line.