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Earnings Call: Q3 2022

Oct 31, 2022

Operator

Welcome to Q-linea's quarter three presentation 2022. Throughout the call, all participants will be on listen only mode, and afterwards there'll be a question and answer session. If you wish to ask a question, please press zero one on your telephone keypad. Today I'm pleased to present CEO, Jonas Jarvius, and CFO, Anders Lundin. Please begin your meeting.

Jonas Jarvius
CEO, Q-linea

Thank you very much for that, and welcome all to our presentation for the third quarter of 2022. We move on to the next slide number two, where we have our disclaimer slide in case me or Anders will make any forward-looking statements. Having looked at slide number two, we move immediately, I think, into slide number three, where we have a high-level summary of activities during this quarter and also a bit after period end. As you know, who have been following us, we are developing disruptive solutions for faster infectious disease diagnostics. The first product targets bloodstream infections, where sepsis is the most severe case.

If you look at some of the statistics from the period, we are running at 174 employees and consultants, so more or less leveling out from what we saw also during the second quarter. We come back very strengthened from a very successful IDWeek, an infectious disease conference held in Washington in October this year. I will come back with some highlights from that conference. As you know, we also filed a 510(k) application for ASTar in June to the FDA, and we are now into discussions with FDA regarding that application. I'm also really proud to say that we have now passed full IVDR certification. We did that in September, and I'll of course come back to what that means for Q-linea and for us as a company and opportunities that that brings.

I think with all the biggest news, which we will focus much of our attention during this call, is that we have now, early this week, that we have jointly agreed together with Thermo Fisher Scientific to end our partnership around ASTar distribution. I will talk a lot about that and of course our strategy moving forward. Apart from ASTar of course, we also have other products in development. As we have earlier announced, we are now in discussions regarding Podler, and I will also touch upon those discussions at the end of my presentation. If we move to slide number four, I just want to ground the importance of what we do. The first application, sepsis, is the leading cause of death in our hospitals.

It's more common than lung, prostate, and breast cancer combined, and it accounts for around 30% of the deaths in the hospitals. It's also the most expensive condition to treat in the United States. For septic patients, the real critical piece of information is what antibiotic should you use to treat this infection? This is what we work with Q-linea, and that's what ASTar provides. By doing so, we of course also aid to have more patients survive from septic episodes. If we move into slide number five, of course, the big topic for today's call is the discussion between Q-linea and Thermo Fisher to jointly end the distribution partnership. Thermo Fisher Scientific, as you know, is a very big company. They had to decide to refocus on their core microbiology businesses.

In that decision, of course, Astrego was not part of that core microbiology business. What I would stress is that the view of Astrego has not changed, either at Thermo Fisher or at the fantastic team we have been working on over the last couple of years. That is the decision that has been taken. Of course, also as you know, Thermo Fisher Scientific had an exclusive distribution partnership with Q-linea. Of course, one important aspect is sales targets. Of course, how much do we think we can bring to the market? We announced in our Q3 report that we are lowering our sales estimates during this year. I'll come back to some of the details, from moving from 20 instrument sales to around 10.

Of course, this is also very important when you are an exclusive distribution partner. This is of course important to meet these targets. What I would say, I really think that's important to stress, that during this year, there's been a number of evaluations of ASTar, and ASTar is truly a great performing system. It has met expectations from customers and of course also the clinical value that it presents. However, together with Thermo Fisher, we continue to work together. As you know, we have been working in clinical studies where Thermo Fisher Scientific performs reference testing. What we need to compare to with ASTar of course, that will continue. Also the commercial customers that have been contacted by Thermo Fisher will be offered to be transferred to Q-linea.

Of course, we see that as a very positive transaction to happen in the near future. Also, apart from that, sales leads that's already in the pipeline that has moved through the sales funnel, also together with ongoing evaluations, will be transferred from Thermo Fisher to Q-linea, and they will of course also support us during this transition. We want to make this smooth for both companies, and also we always keep the customer as a central part here so that the transition would be smooth for them and also actually for us at Q-linea when we do ramp up. I think that is very good news. I would like to see that taking the next steps over the next coming weeks. If we now move into slide number six, why didn't we meet the sales targets?

Well, of course, we have learned a lot during this first initial launch phase. We've performed quite deep analysis in Europe. I would say that there are a couple of factors. One of them is that rapid AST is very young in Europe. There are really very few players in the market. It has not been around for several years, with the difference, of course, if you compare that to the U.S., where we have seen more of that. I'll come back to that. Just a young field. When it's a young field, of course, you need to come to that market, with that knowledge. We have also seen that corona pandemic, all of the immediate effects of the pandemic has really decreased a lot.

We have seen that a lot of hospitals really have stretched budgets for 2022, and we don't see really an opening until next year for that. We have seen some limitations to that availability, but I would say it's really more on the financial aspects that you needed to sort of have 2022 to be able to recoup from the hospital budget. Another strong message, as I talked to you before, is that with a new technology, with a new system, you really want to try before you buy in a sense. They want to see how ASTar performs in their respective clinical setting. How easy it is to operate, what type of data can I get? How can then incorporate this data in the clinical management of patients?

We also see that there's a big ask for clinical and health economic evidence, so here are studies, and I'll also come back a little bit about that. Now when we actually see a couple of companies providing rapid AST solutions, we also see that customers in general would really like to see these systems compare and contrast to each other. Which system is the best in my settings? What are the respective pros and cons? Also, I would say always, in a launch of a new product, the voice of key opinion leaders in the field, scientific evidence is truly important. These are really the highlights, what we have learned and also what we have gotten a more deeper understanding on, during this initial launch period.

If we now take a look at page number seven, this is just some highlights from studies that have been done where customers have either published data or presented them at conferences. Really the performance of ASTar is strong, very easy to use, and the coverage is very broad, meaning that the likelihood of actually being able to act upon the result, I mean, the crucial decision is very high if the load is on, then ASTar. I think we have a good base. The big question is, of course, what do we then do with our lessons learned, and how do we think about the future. We take a look at slide number eight. We think first of all, that launching a new product, a long-term strategy is important.

In a long-term strategy, you will have something that's very critical in the initial phase, intermediate phase, and of course, long-term. I think what we would like to do now, even more actively, is increase awareness for rapid AST in general, and of course, as ASTar being a priority for us. We'll provide further support to key opinion leaders to really provide them with ASTar to be able to do evaluations to test it in their settings. That level of activity will be increased. We also talked about customers really want to see how ASTar performs with other rapid AST solutions in the market. Here, we would like to take a very active role, and we encourage these types of studies.

We are now in really late-stage discussions with several independent, of course, clinical hospitals that want to compare us with other systems on the market. When I look at ASTar performances, I really encourage these types of studies, and I do think that ASTar will perform well in these studies. Also, when we talk about try before you buy it, is we want to increase the commercial footprint. We want to accelerate evaluation and clinical evidence studies. You can see on the map, there's a number of sites that are either commercial customers or being part of developing or supporting these type of activities. Our health economic study, the first one will be focused in the southern Europe. We are already to start.

All the instruments have been installed, all training has been completed, all protocol has been approved, and we really are waiting for the last ethical approval of one remaining site. As soon as we have that, we're ready to really start health economic outcome research studies. Actually, together with Thermo Fisher Scientific, we have entered into discussions of transferring the same leads that they have, and of course, with the ongoing evaluation, so that we can really be prepared to make a smooth transition of what has been done from Thermo Fisher during this year. If we now look at slide number nine, I think what's also important to remember is that, when we signed the agreement with Thermo Fisher Scientific, it was a partnership. It was not a distribution of ASTar.

Because of that being a partnership, we have really been continuously mirrored their organization, and we have focused on some particular aspects during clinical. That mean now that I think we have a very strong commercial and clinical value teams. We have already 15 persons in the commercial organization and seven persons working within clinical value. I do think when I look at clinical, we have really been excellent at supporting the clinical evidence. I mean, when you sell these type of products, it's not only for the microbiology lab, but it's also to the clinicians, the persons who need to act upon the results of ASTar. Of course, we plan to expand that commercial team, and we'll have a very clear focus initially on key geographies, at least internally.

Naturally, we take the lessons learned from Europe, and we also see the commercial adoption of rapid AST in the United States. That to me brings the conclusion that U.S.A will be a key focus for us. We're already in discussion with several hospitals that really would like to try and test our ASTar even before FDA approval. I think that's very positive feedback from the U.S. market. We also, of course, I want to make the preparations, setting up a U.S. Inc., and really start planning for our own sales force in the U.S. In another company I co-founded a number of years ago, Olink, they had to do the same journey going from Sweden to the U.S. I think Jon Heimer and his team have done a very good job at that.

We look at sort of a similar type approach when coming into the U.S. market. For Europe, I think we are in a good place. We can do initial co-commercial coverage from Sweden. We really focus on building awareness in clinic and scientific evidence. We will really focus on the top three European countries before we expand. This is our current thinking. It can change. We have a very, very firm plan on what we want to do over the next 2-3 months, and then of course, going into 2023. That was our story in where we are in direct control. If we take a look at page 10, of course, we're also gonna look at how we can extend these sales capabilities with tentative commercial partnership.

I'm actually quite proud to see that within just a few days of the press release, Q-linea has been approached by several large companies in this field, to start having meetings, and discuss if there is any interest, how we could work together. I think there are a number of reasons for that. I think the primary reason is that, people who have knowledge in this field, they really see the performance of our ASTar and what Q-linea has done over the last number of years. I think we are an interesting company with a very interesting product. Also the partnership with Thermo Fisher, that was focused on our ASTar, meaning that other developments we have running in the company had been open for also discussions with other players in the field.

Where we are right now, and of course, this is fairly early day, but now really trying to evaluate what strategy to best build company shareholder value, both internally with our capabilities, but also, extending that with commercial, tentative partnerships. If we then take a look at page 11, that's a very high level summary of sort of where we are in Europe anyway in the USA on the regulatory side. As I mentioned, FDA, we are in discussions. We're actually waiting feedback from the FDA. As we have announced before, FDA has 90 days to make a clearance or approval of this product. That doesn't mean that it takes 90 days. As soon as they have a question or a comment or want to see some perhaps more evidence, the clock stops.

If you look at an average cycle for similar type of products, it's typically 12-18 months. I think what's very positive from Q-linea side is that we have been classified as a Breakthrough Device. That really means that we have priority with similar devices in our field. We are now in discussion looking at perhaps performing more extended testing. I would also absolutely come back to you when I have some more details around the timeline for FDA approval. I think from Europe, of course, we have not been sitting still there either. I'm extremely happy to say that we have now passed IVDR certification. You may know that Europe is moving from the IVD, the Directive for In Vitro Diagnostic Products, to the IVDR, the regulation.

This really means that Europe becomes more similar to the U.S. You have to have a notified body that approves products. By being one of the first company actually to accomplish this, and of course, the certificate will come typically early 2023, but we're past all the formalities, so to speak. You know that if you are not fully IVDR compliant, you are allowed to sell products that you had on the market before May 26 this year. You are not allowed to place any new products on the market in Europe until you are fully IVDR certified. You are not either allowed to make any sort of major upgrades to a product. I think that Q-linea, with our long-term thinking, we took very early slot to be able to have this audit performed this year.

Now to be able to accomplish that means that we have full sort of freedom to operate and place new products, make product updates. I think that puts us in a very good position compared to some of our colleagues in the field who have not reached this stage yet. If we then take a look at slide number 12, sort of a highlight of some of the activities. Of course, we needed to focus today's talk primarily on the distribution partnership. Podler, again, we are making good progress in development, and we are continuing the commercial collaboration discussions around Podler. I'm really sorry that I can't provide more detail around these discussions right now, but yet again, I will of course come back with you there.

I would, however, say now that when we have both Podler and ASTar within our complete control, we would also like to see what's really the best value for the shareholders and the company. We are sort of revisiting the strategy for ASTar and Podler once again. Also, very importantly, is that we have made some very good steps in the capabilities for consumable production. Key part of our consumables is really the AST disc. We are now in late stage verification of our internal developed equipment for AST disc manufacturing with a much higher throughput. We have automated quality control and much more efficient and uniform manufacturing process. This is, of course, good not just for scale up, but of course also cost of goods for the consumables.

I think that we do make a good progress in the production field. If we can take a look at slide number 13, just one highlight. We just came back from IDWeek. As I said, it's an infectious disease conference. It was held in Washington earlier this month. We can clearly see a difference between U.S. and Europe. We've seen in the U.S. that antimicrobial stewardships are much more broadly established, and they really see phenotypic rapid AST as one of the key needs to reduce time to treatment. If we compare that to Europe, we don't really have so many questions of why rapid AST, but rather when and what technology. Of course, we need to be competitive in the market, but we see that you have come quite further along in that journey.

I know Europe will follow, but I think U.S. is clearly leading this development right now. As I mentioned before, we now see several hospitals that are expressing to really test our ASTar before FDA becomes approved. Of course, this is something that's important for us to have a running start as soon as we have clearance. If we then look at slide number 14. In summary, I mean, of course, separation from Thermo Fisher was not the plan, was not the intent when we entered the partnership two years ago. We clearly have the same vision at the time point, but things can change. Sometimes in large companies, vision can change, and that will have effect in sort of the different branches of the company.

However, what I think is very positive is that we are now in full control of the commercial direction. Both ASTar and all the other products we have, and we see that the interest in our company is strong. I mean, we have developed a good product, and a good company together with all of you. Of course, it will be a transition period before we have fully implemented and decided our new strategy. We have a great product as a good base. We have a clear view on what's needed in EU and U.S. respectively to build the future value. We have commercial customers, a pipeline of evaluations, and sales teams to build from. Of course, we have a continued support from Thermo Fisher during this transition.

Although it was not the intention a couple of years ago, I think that where we are right now, we are in a very good position to actually capitalize on what has been done and also take the next step. I truly look forward on taking that together with all of you in this next journey. That will conclude sort of my overview of events during the third quarter. I will hand over to Anders Lundin, who will walk you through the finance part of that. Welcome, Anders.

Anders Lundin
CFO, Q-linea

Thank you, Jonas. I will go into slide 15. In the income statement for the third quarter, we have net sales of SEK 2.9 million compared to SEK 1.1 million same quarter last year. The operating result was - SEK 58.9 million compared to 50 million. We reported a loss after tax of - SEK 59.4 million. The earnings per share before and after dilution was - 2.03 compared to -1.68 same quarter last year. If I go to slide 16, we have some balance sheet items. Cash in the bank and cash equivalents was SEK 28.9 million. We have short-term investments which consisted of short-term bonds of SEK 65.3 million, and we have non-current assets, which is listed bonds of SEK 63.2 million.

All in all, if I add those assets, it comes up to 154.4. We have inventory of ASTar and consumables of SEK 22.3 million compared to SEK 28.6 million at year-end. Those numbers includes also a write-off reserve of -SEK 4 million. If I go into the slide 17, which is the cash flow. The cash outflow from operating activities was -SEK 55.4 compared to -SEK 63 same quarter last year. We see a decrease in outflow, mainly due to the favorable changes in the working capital, but it's partly offset, of course, by the lower operating result this quarter. We have investing activities of SEK 64.5, which is sale or net investment of short-term interest funds.

We have invested in production equipment of SEK 0.9 million compared to SEK 2.7 million same quarter last year. The cash flow from financing activities is very low, Zero this quarter, -0.1 and represents payback of loans, which are now fully repaid since quarter two this year. As I said, if I add together the assets that we can convert into cash, we have SEK 154.4 million, which is, and that is compared to the year-end, we have 347.8. With the current business plan that we are working on, it is the board's assessment that this existing working capital does not cover what the company needs, and plan for during the next twelve months. That we will come back with.

With that, I would like to hand back to Jonas, and he can conclude the call.

Jonas Jarvius
CEO, Q-linea

Thank you very much, Anders. We just put up slide number 18, where we see that our vision and our ambition has not changed since last week. We still want to contribute to healthier society by future-proofing a new generation of healthcare professional labs and hospitals. I think we are on a good journey of doing that. With that said, I would thank you all for listening in to our presentation for the third quarter. I will hand back to the operator and open up for any questions. Thank you very much.

Operator

Thank you. If you wish to ask a question, please press zero one on your telephone keypad. If you wish to withdraw your question, you may do so by pressing zero two to cancel. Our first question comes from Gonzalo Almeida from ABG. Please go ahead. Your line is now open.

Gonzalo Almeida
Socio director, ABG

Hi. Thank you for taking my questions. I have a couple. The first one, I know that you won't give a number at this point, presumably, but, we are two months from 2023. I wonder if you could provide some comments around your expectations for ASTar sales in 2023. Could you confirm whether the expectation for European sales next year is for broadly similar sales as in 2022, or whether you expect to materially grow sales next year?

Jonas Jarvius
CEO, Q-linea

Well, thank you much, Gonzalo, for that question. Yeah. Sorry, I will not comment on the details for 2023 just yet, since we're working on this overall plan. What I do say, and what I would envision is 2023 to be a better year than 2022 for a couple of reasons. Yes, we are now moving away from our partner, but as I said, we have during this year been performing a number of evaluations and of course discussing with sales leads. I think a lot of the work that has been done here, of course we want to see the fruits of that during next year. I will not provide any details yet. We come back with that. We do see next year at least is a better year.

What I should say and what is important is that of course, putting in a new strategy in place will take time. Under all circumstances, we really see 2023 as a year of transformation of setting the new organization in place and having it set in motion. I think that's sort of the high level answer I can provide if that would be okay for you.

Gonzalo Almeida
Socio director, ABG

Thank you very much. Second one, can we expect any P&L impact from the ASTar systems that Thermo will return to you to Q-linea?

Jonas Jarvius
CEO, Q-linea

Yeah. I mean, of course, the commercial contracts, and of course that has to be agreed with the customer that they can be transitioned. I have a very good faith that that could happen. Of course, one commercial contract with the broad panel, that will hit that for sure, yes.

Gonzalo Almeida
Socio director, ABG

Okay. Thank you. Thank you very much. Next one, it's on your 510(k) application to the FDA. In the report, you mentioned discussions on potential expanded testing. Could you clarify what this means? Is this additional testing beyond what Q-linea has submitted in order to secure 510(k) approval for gram-negative use, or is to expand the approval, so to say, to include gram-positive or other samples?

Jonas Jarvius
CEO, Q-linea

Right. Yeah. I mean, when we did file our 510(k) application, it has been the most comprehensive filing in our field really. We have a very broad panel. What we are discussing now is expanding tentatively, I would say, some testing on the gram-negative. The reason for that might be that since we have such a broad panel, in some cases you might have certain limitations to find the isolates needed for that. That's a discussion. It has not been decided yet. That's something that we are considering and of course discussing together to see what will be eventually decided to do moving forward. It's the focus for the gram-negative panel.

Gonzalo Almeida
Socio director, ABG

Okay. Thank you very much. A fourth one, it's on the portion of the commercialization that you will look to bring in-house. Could you provide some color on how big a sales force needs to be to cover a certain region, let's say Scandinavia or Northern Europe? How soon in time can we expect to see begin to build the sales force?

Jonas Jarvius
CEO, Q-linea

Right. Yeah. I think we have quite a good sales force already to handle Scandinavia. For that, we don't really have to scale up, in my opinion. Of course, if you want to expand onto other geographies, it will depend a little bit on the country at hand. We don't see that Q-linea would build hundreds of people in sales. We don't think that's needed. There is fairly good segmentation of this market that needs to be targeted. I basically would say it will look something like between 8-15 people, if you decide to go directly in a country, because we still have the back-end support from here.

We tend to do it quite orderly, and I think we can do it in a very well sort of staged fashion really, as we approach each region. The exact numbers are not that, but it gives you some high-level triangulation that I think could be valuable.

Gonzalo Almeida
Socio director, ABG

Okay, thank you very much. Just last one, before jumping back to the queue is just to clarify on my previous question on the PNL impact, I was more asking about whether we can expect any negative PNL impact from systems that have been get sold to customers being returned from Thermo Fisher to Q-linea.

Jonas Jarvius
CEO, Q-linea

I don't think I can comment that as of yet. That's one part of the discussions, how we are gonna do with that. I can't really provide any detail on that as of today.

Gonzalo Almeida
Socio director, ABG

Okay, I understand. Thank you very much.

Jonas Jarvius
CEO, Q-linea

Thank you very much.

Operator

Thank you. The next question comes from Ulrik Platzer from Kempen. Please go ahead. Your line is now open.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Great. Thank you very much. Good day, Jonas and Anders. I have a few. Yeah, obviously some turbulence here with your divorce from Thermo Fisher. You state in your CA wording that you're seeing sort of continued strong interest in your products from other major companies in the market. If you could please clarify that. I think majority of us know that bioMérieux has acquired Specific Diagnostics here in recent time, and that Becton Dickinson have a commercial partnership with Accelerate Diagnostics. Who's actually left there to actually partner up with you guys? Do you plan on, like, looking into the future, do you believe it will be a deal specific regarding ASTar or would it be to include the Podler as well? That would be my first question. Thank you.

Jonas Jarvius
CEO, Q-linea

Thank you, Ulrik. Thanks for good questions. Well, what I can say is really what we have seen is really that within just the last couple of days from our press release, several of the biggest companies have approached us and are open to discussions. Of course, we have been in discussion with some of these companies continuously, of course, because everything that was not ASTar was something that we could have a continued dialogue around. Without being too specific, I would neither include nor exclude any company in this field, no matter what their previous position has been. What I clearly believe in my sense is that most of these companies working in the field have really seen ASTar.

They have seen Q-linea and our progression, and they're now actually seeing what ASTar performs. To me it's really encouraging to see that what we set out to deliver, we have delivered that. It's precisely the system with a broad coverage, simple to use automation, random access. I know it's not necessarily the answer you want, Ulrik, but I would basically say that neither rule in nor rule out any company at this stage. Coming back to sort of the follow-up part of your question was really looking at how do we think about ASTar and Podler. I would say that it all depends.

I think it's important now to actually be in control of our destiny, so to speak, to make sure that we are at the steering wheel and controlling the next steps moving forward. No matter how we decide to tentatively enter a new partnership or so, I think it will be done at a very different level from last time. First of all, we are much more mature. We have been building up our commercial and clinical value during these last two years. I think that we need to see really how that should look like to really increase the value. This is something of course I would be happy to come back and provide more detail as discussions are progressing.

I think it's a very open atmosphere out there as of today.

Ulrik Platzer
Analyst, Kepler Cheuvreux

If I were to play the bears argument here, you're looking at placing roughly 10 systems in Europe throughout 2022. Thermo Fisher obviously have addressed sort of their attention elsewhere. One could argue that interest in fully automated rapid AST is rather low. So how would you just comment on that? Follow-up question on that would be, given that you now are not under the thumb of Thermo Fisher anymore, when are you to announce how many valuation contracts are out there currently? Maybe we could see a gradual pickup in placements.

Jonas Jarvius
CEO, Q-linea

Yeah. I'll start with the first part of the question. Well, I think this comes back a little bit to what I said about long-term ambition. We need to understand that rapid AST is a young field in Europe. There's really been no companies offering rapid AST for a large number of years. I think that to get the traction, you also need to be perhaps even more active in placing instruments at the correct sites and have a very active evaluation pipeline. I think that you might be right in that the adoption has been lower than we hoped for. I would agree to that. I would not say that there's a lack of interest for rapid AST.

We have seen throughout the year that we have had more requests to do evaluation than has been performed. Of course, we want to change that as well. I think in Europe, as I said in the presentation, one needs to focus on really what do Europe need now to really go into the sort of commercial mode of this product. I think we need more KOL voices of customers. I think we need more evaluations and more clinical support and evidence around rapid AST. I think that adoption in Europe will be slower than adoption will likely look like in the U.S. because the U.S. has been working with rapid AST. Accelerate has some 300+ placements.

Also the voice of customers from IDWeek is much more not really sort of why do we need it in that sense, but really how and what type of system. I think that's gonna be instrumental to put this in motion. Here I think that a good view of lessons learned is what you should utilize in your strategy going forward. On the second part of the question, this is something we're currently discussing within the board, but of course now that when we are in full control of our commercial activities, we are gonna revise our way to be able to present a little bit more what you're asking for, number of evals, how we are progressing in the commercial pipeline.

I'm not looking at sending press releases every time we have an evaluation going on. I don't think that's the right strategy. For sure, we should provide more details in the quarter reports, and we're gonna try to keep you and the market more updated, particularly now in this transition period. We have to balance that to see that it sort of gives you more information, but also that significant one when it comes.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Okay, great. Two more questions on my end. The first would be on the FDA process and the 510(k). As you mentioned, well, the wording that you're phrasing in the CEO wording looks like the FDA has a lot of outstanding questions regarding the applications. So what are the topics of discussions right now, and how does this sort of process, not generally from an FDA standpoint, but in your personal experience handling the registration of ASTar in Europe versus FDA, what are their concerns?

Jonas Jarvius
CEO, Q-linea

Well, I mean, I wouldn't say really. I think that typically FDA always have a number of questions. That goes for any type of filing. I don't think that's unusual at all. I think what's discussed really now is that the way we do it, did it in Europe, of course, we make a study, and then of course, we have improved algorithms. That's ongoing work. Of course, you retest it with the latest gen of algorithms. The real purpose of doing it that way is of course also to have the latest software up to the system. I think the discussions are more general now looking at what could be needed, if any, in further testing. I wouldn't say that we have any sort of specific topic or.

It's just sort of an overall review of quite an extensive filing. Coupled to your timing, I would say that we do have results going forward and back with FDA. I would say, hand on my heart actually, I'm really happy that we have Breakthrough because of course, the process, I would have loved it to be even faster, and I guess any company would say that. I think that with the Breakthrough, we are at least first in line, and I think that's good. No real particular focus that I can highlight, but it's just a lot of things to digest. FDA of course want that clarification on the full entirety of the application, so which was quite a big one.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Great. Thank you very much. Last question that would be on the cash end. I think a lot of us can conclude that current cash is not really sufficient in order for you to establish your own sales force and run this into positive cash flow. That leads me to look at the potential commercialization of Podler and licensing agreement. Where are you standing on that? I know that you want to disclose more when it's possible, but would you believe that the current discussion and letter of intent would at least put it in a phase that it would mitigate the capital need going forward? Is this letter of intent that you announced last quarterly report, is that still active or is it a completely different discussion right now?

Jonas Jarvius
CEO, Q-linea

Right. First of all, let me comment on the other side. Of course, when we look at our sort of running concerns, it of course then includes now building sales force. That's included in that statement. I think that when we look at cash going forward, Podler could definitely be one aspect to that for sure. I think there are also a lot of other options that we have at hand here that the board is currently revisiting. I would say that there are a number of opportunities to take the next step going forward. I think also as well as we did early on with ASTar, of course now when we are in control of ASTar and Podler together, a week ago it was Podler and not ASTar.

I think we should also really consider what's the best long-term value. Is it to move actively forward with a Podler discussion? We are in those. Is it to look at the combined package and think what really could bring a steeper value curve moving forward. Not necessarily easy decisions to take, but I think I'm quite fortunate we can have these type of options to our table. I would say we have a number of opportunities here, and we are really looking into what's the best for our shareholders, what's the best for taking Q-linea into the next step. In the future. I think that's answering a little bit around your question, Ulrik, but I think it also describes a little bit about opportunities currently being discussed internally in the company.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Great. Just a follow-up question on Podler. Because, yeah, it looks like to be a good value driver for you guys in the coming years. But on our end, on the sell side, it's hard to pin down a value since we don't have sufficient information on when clinical trials are to start or the size of these and roughly the capital need. When should we expect to receive those type of comments so we can be more certain on the development pathway of Podler?

Jonas Jarvius
CEO, Q-linea

Right. I think that's an excellent question, Ulrik. I would say that we are really looking into providing some more nuances around Podler and timing. I wouldn't be surprised to see more information coming out definitely before year-end report is published to give a little bit better guidance on timing and thoughts around Podler. Not necessarily very long away. The reason that we have been not talking so much about Podler is also to see that every shareholder knows that what we are doing, what we're focusing on, is providing traction for ASTar and putting our real efforts there.

We are gonna have that as a top priority going forward, naturally, continue these discussions with Podler, but then also be able to provide a little bit more granularity on timing around our current thinking about timing for Podler. That's gonna come here in the not too long distant future, Ulrik.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Just one more question on my end. Sorry for squeezing another one in.

Jonas Jarvius
CEO, Q-linea

Mm-hmm.

Ulrik Platzer
Analyst, Kepler Cheuvreux

How about the rest of the IP portfolio? I know that that's one of your colleague company, if we were to call them like that, Astrego in Uppsala. They were acquired by a company which are looking at what I believe to be more urine analysis and quite similar to your system, ASTar. Would you look into divesting certain parts of your IP portfolio or to partner that type of IP, given that there is obviously a industry interest for those products and IPs as well?

Jonas Jarvius
CEO, Q-linea

I think that's also an excellent question. I think when we look at Q-linea, first of all, I think we're an absolute unique company. Maybe all CEOs would state that for their companies. Really when you look at our technology and our IP coverage, I mean, apart from Podler and AstAr, of course, which we have talked a lot, we have absolutely unique, highly multiplexed molecular technology, also an area of increased interest. No one has so far beaten us in multiplexing for bacteria identification, for instance. Also, as you talk about AstAr, sort of ultra-rapid UTI testing. Of course, when we are now moving on in our strategy, you will always have a couple of key cores that you want to focus sort of your primary efforts around.

Everything else you have in the company, you always have to decide, is this the best long-term value for the company, or should we try to divest it to bring more energy into the other sort of higher priorities currently? I think we are, sort of as I mentioned before, in a very fortunate situation that we're not the company that's the one-trick pony. I think first of all, our horse in the race, ASTar, has proven to be an excellent one to bet on. We do have much more under the CE-IVD. We have quite an extensive, in my opinion, IP portfolio. You can imagine we're looking at really what's the best next step for us to add and increase shareholder value.

Yes, to be able to be in that position, I mean, we have been building the company long term, and we have no change of view of where we want to be in the long run. We have a number of options, and we are gonna really look into those options quite heavily, of course, over the next following month. Yeah, a good question. I can't give a direct answer more than, of course, that's an opportunity for us to look into.

Ulrik Platzer
Analyst, Kepler Cheuvreux

Great. That was all questions on my end. Thank you very much.

Jonas Jarvius
CEO, Q-linea

Thank you very much, Ulrik.

Operator

Thank you. A reminder, if you wish to ask a question, please press zero one on your telephone keypad. No further questions at this time. I hand over back to you, Jonas and Anders, for any closing remarks.

Jonas Jarvius
CEO, Q-linea

Okay. First of all, thank you all for coming and dialing into this meeting. I know that it's a lot of activity to happen and of course, big news in change of distribution, but clearly has not put any change in my mind that we are really on the right track. Now we can really take control, take the next steps, and I think we have a very good way of doing so. I look forward to coming back to you, of course, not waiting until the next report, but hopefully in the time between and give you some more news on where we're going. With that, I would like to say thank you from my side and Anders' side and hope to talk to you again soon. Thank you very much.

Anders Lundin
CFO, Q-linea

Thank you.

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