Q linea AB

STO:QLINEA

Earnings Call Transcript 2024-Q1

[Operator]

Welcome to the Q-linea Q1 Report 2024. [Operator Instructions] Now I will hand the conference over to CEO, Stuart Gander; and CFO, Christer Samuelsson. Please go ahead.

[Stuart Gander, executive]

Hello, everyone. Welcome to the call. Happy Friday and thank you for joining this presentation of Q-linea's Q1 report for 2024. You have Stuart Gander here, the CEO speaking. I'm joined by my CFO, Christer Samuelsson, who will speak towards the end of the call. So we'll split the time between some updates and comments from my side initially before I'll hand over the baton to Christer who will speak to our financial update in more detail and then we'll open up at the end for questions.

So with that, I wanted to just start by highlighting a couple key messages that we would like everyone to take away from the session today. So first of all, we're extremely proud and happy to announce -- or have announced that we achieved FDA clearance for the ASTar product as of April 26, which is a huge breakthrough for us and opens up the U.S. market for full commercial activities.

We've been present in the U.S. for some time now with premarketing activities. I'll speak to that more in detail in a few minutes. But until we have clearance, we were not able to have full commercial discussions on, for example, pricing and placing commercial evaluation. So we are now able to do those activities and we're seeing the interest growing in the market commensurately.

Secondly, we have presented during the quarter some initial results from our ongoing clinical studies with our scientific partners in Europe. These results were presented at a couple of conferences, which I'll speak to in more detail with strong reception and those data coming from the clinical trials are showing very positive results in favor of rapid AST and the potential for improving patient outcomes.

Thirdly, we have completed as of this month, essentially, the cost-saving program that we announced earlier. This program is anticipated to generate SEK 50 million of annual savings versus our run rate coming off the back of last year. With the completion of the program, we can confirm that we will achieve this target and those should be fully visible in our P&L from July onwards.

And then finally, from a main messages perspective, you will have seen the announcement that Q-linea has achieved additional financial facility from Nexttobe in the form of loan facility. Christer will speak more to the terms of this towards the back end of the call. But this gives us an additional total amount available of SEK 101.5 million, including some of the remaining facilities that was available to us before that has been extended. So Christer will speak more to those terms. But we're happy to announce that we now have the financial cash resources to continue our commercialization progress.

So with that, I'll go into a few more detailed comments from my view on the quarter and a little bit of year-to-date. So overall, for me, personally, it's been a fast and furious first 90 days in role as the CEO, having started in March. We did have 1 month of handover with Jonas Jarvius. I was very appreciative of as were able to get up to speed with everything and I feel that the handover has gone very smoothly and I'm still in regular contact with Jonas and he is still very supportive of any questions or needs that we have.

But from an operational perspective, we're now up and running fully. I have on my plate really 4 key priorities that I've been pursuing over the past months. So firstly, ensuring that we continue to accelerate our commercial activities and commercial traction in the market. On that note, we did ship our first commercial instrument into Italy. So that is up and running. We announced that tender win earlier and we're happy to announce that, that has been set up and it's being used now clinically. So those patients in Tor Vergata are now receiving the benefits of rapid AST which is very fulfilling for us to see as a team that we're now having real clinical impact in the market.

As I mentioned, we also had strong reception for our clinical results presented at the Italian conference, AMCLI, where we were able to present to a very large audience there of attendees and also at ESCMID where we shared some posters highlighting the findings from the interims -- interim findings from those studies.

And then finally, on the commercial side, our efforts have really been focused now on ramping up the U.S. pipeline. Following FDA approval, we have we received very strong interest from a number of customers that are now preparing commercial evaluations, which we anticipate to be going in over the coming months and also in parallel, have continued our efforts across Europe, working with our distributors. We have a number of evaluations on the European side also planned that we expect will materialize into signed contracts and tender wins hopefully over the coming months.

The secondary priority for me has been continuing our innovation in the field of rapid AST and our product development. Obviously, with the keystone here of our FDA approval for our version 1 menu in the U.S., we're very pleased but we don't stop there. We will continue to evolve and expand our offering in rapid AST. So we've already completed a pre-submission for a version 2 menu into the U.S. that will give us more drug and drug combinations. And we continue our efforts in a focused manner on building out more capabilities that are inherent to the ASTar platform, notably expansion the menu into Gram-positive bacteria. So our R&D efforts are focused and really oriented around expanding the value proposition from the ASTar platform.

My third area of priority over the past months has been around organizational readiness. Obviously, coming in, in the process of an organizational restructuring, there was a lot going on and I wanted to make sure I was spending my time ensuring that I understood how everything is working at Q-linea and how best to optimize after the restructuring is complete. So with that done, I think we're now in very good shape to pursue our commercial growth agenda and to continue our R&D efforts.

The reduction of staff that was implicit in the restructuring program has also enabled us to consolidate the team into a single office. Previously, we were in a couple of locations in the Uppsala Science Park. So this, of course, has some additional benefits of savings on the facility cost side. But I would note that across the team, it's been commented, it's also allowed us to increase the energy and interaction as the team is now all colocated. So a nice positive from a company culture perspective.

And then finally, we have arranged for our 3PL logistics in the U.S. in anticipation of the clearance and now we will be making commercial shipments of our products. So we wanted to ensure that we were set up in advance of that. And we have a good partner in the [indiscernible] area who will enable all of our in-market logistics going forward. So that's in place.

And then my fourth area of focus has really been around securing and continuing the financial health of the business, obviously, working with Christer and the Board and the whole team, working through the cost savings plan to make sure we get everything that was expected from that and also continuing to look for further ways to optimize our spending, ensuring that we keep the focus on the commercial activities. Overall, I'm very happy to say that we're ahead of the plan and we're seeing those savings realized in the P&L, even a little bit ahead of plan.

So for me, the focus really going forward is around achieving the top line growth results and I'll speak more to what we're doing there, while ensuring that we keep very conscientious use of our resources against our mission and our priority activities. And then I already commented on securing the financial loan from Nexttobe, which gives us now the runway to continue.

So with those highlights, I'll go into a few more detailed comments on those points. So just on the FDA clearance, those of you who've looked online will have noted our panel that's been approved, you can see it here. We're very proud of this. It is the largest panel available for Gram-negative testing in the market 18 with antibiotics and 12 microbial species. I would highlight that the ASTar platform has the unique capability of providing multiple dilutions for each of the antibiotics which gives a more granular result for the lab manager and the consulting physician and therefore, a better ability to adjust the treatment for the patient. So that's a benefit that's just intrinsic to the way the ASTar disc is designed.

So this -- well, this panel, we're very happy with and allows us to get active in the market right away. We have a larger panel available in Europe and we will continue to work with the FDA and our clinical work and clinical data work in the background to ensure that we have an approval pathway for an expanded panel.

So the value proposition that we're bringing into the market is really centered around the core features and benefits of the ASTar platform. First of all, a fast turnaround time for clinical results of 6 hours or less. This time versus the standard of care, which can take days, has an immediate benefit of saving lives in sepsis but also saves money for the hospital. And sepsis is one of the most and overall, the most costly treatment in an in-hospital environment across markets. And also, a quick result means the lab can close the case and reduces the effort and time needed for lab management in following up.

And I'll now note the actual test platform itself has 2 minutes or less of hands-on time in the workflow, which is extraordinary in a diagnostic environment. Very simple instrument interface where a lab tech requires limited training, very intuitive usage. And it's a true load-and-go platform, which means the -- there are just a couple of steps to do. You place the cartridge and the disk in the instrument and the lab tech can walk away. And the instruments already indicates exactly what time the results will be ready, so they can plan for that in their workflow.

And then as I mentioned, this is the most robust menu in the market. It's also the first fully automated random access platform available in the market with that comprehensive menu, very high reproducibility results. And the ability to load 12 concurrent patients onto the platform is unique and provides a high throughput for the largest labs even in the U.S. So I'll speak more to that in a second in terms of our addressable customer base.

The results of the U.S. clinical data that were generated were very positive. I won't go into the details here but you can see the data coming out of our clinical study against the requirements for FDA approval and ISO standards. So the results were extremely robust. We're very proud of that.

The chart on the lower right-hand side, we've shared before, it's just an illustration of the total menu potential for the ASTar disc on the Gram-negative side versus some selected competitors. And you can see that the benefits of those drug-bug combinations in combination with the high number of dilution measurements per antibiotic gives us a much more granular results for the physician than anything else available on the market, which we think is a very compelling proposition for labs and physicians.

So what are we focused on now? Our efforts are really tuned to bringing ASTar into the U.S. markets. We've obviously started with some of the major players in the space. Prior to FDA approval, we've been engaging with some of the key opinion leaders and research leaders in the field in our early access program, which has meant that a number of facilities and their researchers are now intimately aware of the benefits and the relative superiority of ASTar vis-a-vis other alternatives. And this will help us in terms of accelerating our commercial efforts in the U.S. market.

And what we're really focused on is all the hospitals and labs of sort of a medium-size and above, this is not a point-of-care solution for a small clinic. But that said, the facilities we're targeting address 90% of the total blood culture sets or the total number of patients for sepsis in the U.S. market. And as I said earlier, our platform is very well tuned to the needs of these extremely busy and physically constrained labs. They have limited amount of bench space and the ASTar instrument has been elegantly designed to fit in well in the lab and have that very easy workflow.

So we will be focused on building that pipeline but we've already got interest from dozens of customers and are now working through timing essentially for getting those evaluation systems in. So customers can try it in real-time in their clinic and make the decision for purchasing based on that.

So as I mentioned, we were present at ESCMID 2024 in Barcelona at the end of April. Timing could not have been better since our FDA approval virtually came at the opening of the conference, which was yet another reason for folks to be interested and come on by the Q-linea booth, which was very busy throughout the conference. I would note that it was very interesting to see that rapid AST was one of the overall themes for the conference. There were numerous scientific seminars hosted by researchers in the field and papers published independent of those that were presented from Q-linea's sponsored investigators. So it is clearly an area of high interest in microbiology.

There is an acute awareness of the need for a better solution for sepsis for the patient population and a growing awareness of the technical capabilities of these emerging technologies, which we see ASTar as the leading proposition from a technical perspective. So we had a high amount of interest in our booth, both from customers right around the world. This conference is the largest one globally with almost 16,000 attendees. So it really was interesting to see the level of interest but also the preawareness from customers in Asia, Middle East, the Americas, et cetera, who wanted to come by and hear more. So this gives us a lot of energy to continue to pursue our global growth ambition and it's now translating -- after discussions with a number of potential distribution partners, is now translating into tangible conversations. We will planfully be expanding our global footprint over the coming months and quarters.

And as I mentioned, the clinical evidence base is growing. So both studies that have been sponsored by other third parties but also those that we're closely involved with. We had the opportunity, as I mentioned, to present these to conference attendees, very well attended sessions with a lot of interest. But really, the highlights here are the clinical results that we feel speak for themselves. So we have an ongoing HEOR, health economics and outcome research study ongoing in Italy. It's a multisite study that is generating some very robust data, demonstrating that the impact of using rapid AST can shorten the amount of time for their patients from between 20 and 34 hours versus the current standard of care. In an environment of septic infection for patients, that is a tremendous improvement. The ability to adjust therapy and give life-saving drugs in a timely fashion is critical for positive outcomes for patients with sepsis.

What we also see from the study is that a significant share of those patients, 45% of them are receiving adjusted therapy. This is in line with previous studies that have indicated that up to half of patients are receiving suboptimal therapy. And this study is reinforcing that in a real-life environment.

And then finally, of those that are receiving adjusted therapy, 46% of them are escalations in the therapy. That is they're getting a more aggressive treatment protocol. So one can infer from that, that without the treatment, the drugs that were being used previously would not have been as effective due to the resistance profile of the bacteria and therefore, the septic infection outcomes would likely to have been much worse.

So I think this just speaks to the critical importance of using this but half the patients are getting their therapy adjusted. And of the total patients, 1/4 of them are being escalated to improved therapy to combat resistant drug profile. So that for us really speaks to the mission that we're on in Q-linea to improve sepsis outcomes around the world.

So as I've said, on the back of all this, we're really focused on accelerating our commercial efforts. In the near term, it's really around building the pipeline in the markets that we're active in, both through our distribution and direct sales activities in the European market that we've spoken to previously, which we see continuing to generate good feedback and we anticipate communicating some additional tender wins in the near future. But also as I keep coming back to, critically the U.S. market where we're now fully engaged commercially across the country. The U.S. market is the most important one just due to its sheer size. But also notably, the U.S. is slightly more familiar with rapid AST. There has been another solution on the market for a longer period of time, which has generated awareness of the technical feasibility and opportunity from rapid AST. And we would position ASTar as a next-generation solution with improved technical performance and improved opportunities for the lab. And therefore, we anticipate that adoption will continue to grow in the U.S. on the back of an improved solution available.

And as I said, we've got a couple of early access programs ongoing. We concluded agreements with additional early access candidates and are also now planning for commercial evaluation of this over the coming months.

And our efforts don't stop with the existing ASTar offering. Obviously, we're very pleased with what's on the market but we continue to look to the next generation of offering over the next 12, 24 and 36 months. And really, we're focused on that expanded panel. So additional drug-bug combinations, as I mentioned before. This will be an evergreen R&D topic for us as the world will benefit from continued innovation on the pharmaceutical side, bringing new drugs to market. That means we need to keep the menu up-to-date over time. So we will continue to follow the developments in pharmaceutical treatments available for patients and anticipate those.

But in addition to that and are continuing our mission to expand the offering into Gram-positive and then the ability to use ASTar for isolate testing and additional sample types, such as urine, lung swabs, et cetera, which we're excited about the opportunity and we'll develop these over time.

I'll speak more in just a second but we are very proud of the innovations in Podler and some of the other proof-of-concept prototypes that we have for point of care and our ASTrID direct-from-blood solution. These we see further down the road. So our R&D efforts are -- have been prioritized into the ASTar for now but there's a lot of spillover benefits from the ASTar work that we're doing into other areas.

And in order to facilitate the development of Podler, we have put that into a separate company structure that Christer can speak to in more detail. This has received a third-party valuation of SEK 70 million, which speaks to the value potential here in Podler, which really promises to deliver a more efficient management of the blood culture and utilize any time of shipping the blood culture around between the point of drawing a culture where the patient is located and allow doing the test, using that time already to culture the blood for the test, which has the potential to further reduce the amount of time between an alarm going off for the patients at risk of sepsis and being able to give them adjusted appropriate therapy.

So Podler is a benefit multiplier of the ASTar proposition. And setting it up in its own entity here gives us the opportunity to work with additional third parties, both for investment but also from a strategic perspective to bring this into the market. I would say that we are having conversations with customers on Podler and receiving positive feedback. There's interest here that gives us further motivation to develop the product.

So final note there, as I mentioned, concluding the restructuring program with those benefits fully realized and seen in the P&L from July onward. And looking forward, how we're allocating our resources, really concentrating on our commercial activities, especially in the U.S., while at the same time, managing our R&D pipeline. We've reduced the overall investment into our development organization by around half versus our previous run rate coming off last year but are nonetheless able to drive our priority programs in the R&D team. And obviously, we have a little bit of our keeping the lights on activities in support of the overall company efforts. But we've also been able to reduce our overheads through the restructuring program considerably by nearly a quarter.

And then the other area that we are attentive of in terms of the use of our resources is the deployment of working capital as we scale up our sales activities, both in the form of instruments placed in the field, where we expect in Europe, especially, a majority of the instruments we placed under reagent rental contracts, which means we get paid over the duration of the contract, which can typically be between 3 and 5 years. And while in the U.S., we do expect more capital purchases of instruments, there will still be reagent contracts in the U.S. as well. So this will require some working capital. Christer and the team are already working on alternate options to finance that over time as we will have signed contracts from customers that should enable some alternate ways of financing those but nonetheless, something we need to be planful of in terms of utilizing our precious resources. And then, of course, obviously, the inventory and the account receivables -- accounts that are expected to grow with the business as well.

So with that, I think that's a good segue over to Christer. I'll ask Christer to speak to more detail on our financial results here from the quarter and then we can turn it over for questions. Christer?

[Johan Unnerus, analyst]

Thank you, Stuart. Thank you, Stuart. I'll continue with the financial section and start off with some financial highlights during the first quarter and after the first quarter.

As Stuart earlier said, we have a cost savings program in place, a good start. We have a restructuring cost linked to that, one of SEK 5 million that will be taken before the half year. It will be taken in Q2. And then we expect the cost savings to have full effect as from Q3 and onwards, as Stuart said before, which is good.

And we will shift the spending from development to more commercial. I mean, it's accelerated by the FDA clearance, also outlined by Stuart before. And then we have a decision to transfer the Podler technology and we have done that in a separate company. It's also been valued at SEK 70 million by an external analysis firm. And the effect on that one financially is primarily that it will strengthen the parent company equity with the same amount.

And as published before, we have an additional loan facility offered by our main owner, Nexttobe on May 29, it was Wednesday this week. It's subject to approval by the AGM in June. And we have -- also before that, we had an existing facility of SEK 41.5 million. This additional facility proposed is SEK 60 million. All in all, that means that we have a facility from Nexttobe of SEK 101.5 million. As of March 31, we had SEK 29.3 million cash at bank, which means that we, all in all, including the SEK 60 million that is to be decided at the next -- at the upcoming AGM, we have a total of EUR 130.8 million.

Little bit on our results. We have an operating result of minus SEK 18.6 million per month in the first quarter, the amount is minus SEK 55.9 million for the full quarter. It's better, SEK 6 million better than last year quarter Q1 in 2023.

Continuing and stepping into the consolidated status of the profit and loss for the first quarter. We have top line revenues. The SEK 2.9 million can be split 50-50 between sales of instruments and consumables and other operating income, which we are glad to report. As I said before, the operating result was minus SEK 55.9 million and it's better than last year, I've already said that. And the improvement is primarily linked to the cost savings program in 2023, which was the first program. The program we have talked about previously here is the second program for this year.

The company -- well, we reported -- loss after tax is minus SEK 56 million, SEK 5 million better than last year.

Earnings per share have a dramatic shift as compared to last year. This is, of course, primarily linked to the rights issue last year when the number of shares increased quite a lot. You can see that it's 117 million now as compared to the 29 million last year. And as I said before, the cost savings program is already visible but with full effect in Q3 this year.

And the financial position end of first quarter, some -- repeat some of the numbers here. Cash at bank, SEK 29.3 million. The decrease -- the average monthly decrease as from beginning of the year is SEK 17.5 million. We have a remaining loan facility of SEK 41.5 million, end of March. That's a total of SEK 70.8 million, end of March. Also we have inventories, fairly high number of inventories, the amount, SEK 43.5 million. But we are rather happy right now because a large part of that is instruments, which just suits us well now in this early commercial phase that we are into, which means that we can deliver instruments fairly quickly and be aggressive on that side.

The equity, end of March is SEK 133.8 million, which is SEK 18.6 million average monthly decrease during Q1. As you can see here, the equity runway is longer than the liquidity runway. But with the increased loan facility, which was press released earlier this week, these 2 runways will balance.

And then stepping into the future financing and still this will be repeating a bit of what I've said before, just to summarize where we are and how we see it. As I said, we have SEK 70.8 million as of 31st of March. Out of the new -- or the existing facility of SEK 41.5 million, SEK 15 million has been paid out 13th of May. Then we have the additional loan facility of SEK 60 million, as I've said before, which means that we have a total facility SEK 101.5 million, subject, of course, to the approval at the AGM.

And the third thing I've said before, which we don't need to take again and more importantly, in the report, we have reported that we do not have going concern. We are in an early commercialization phase. We are FDA cleared, which is very positive. And the pipeline or sales funnel is growing in Europe and in the U.S. But we have to be engaged in finding other means of financing and that includes strategic partnerships, capitalization of existing assets. Stuart mentioned, Podler, which is, of course, is one of the assets we might capitalize on. And then, of course, to negotiate with new and existing investors, financiers and lenders, is always an option. In the light of this, it is the Board of Directors' assessment that the group successfully will be able to finance company operations going forward.

That concludes the financial section. Stuart, I hand over to you.

[Stuart Gander, executive]

Thank you, Christer. And that concludes our presentation portion of the event here. So I'll turn it over to questions.

[Operator]

[Operator Instructions] The next question comes from Johan Unnerus from Redeye.

[Johan Unnerus, analyst]

I have a few, if okay. Can I start off with the pipeline in Europe? You have an instrument commercially, clinically installed already and you have -- you referred to a pipeline of several tenders and also pilots. Can you -- what should we expect here over the coming quarters?

[Stuart Gander, executive]

Yes. So the question was related to our European pipeline and sales development. It's always difficult to pinpoint exactly when a tender will close and be announced down to the month because it's obviously at the discretion of the customer. But we're active in several tenders right now that we expect to close in the coming months. Obviously, can't guarantee that we'll win all of them but we expect to be well placed and are hopeful that these will be positive outcomes for ASTar. So within the next few months, we would expect to be able to announce some of these.

We also, to the extent we can be transparent, we'll be -- continue to be transparent on the evaluations and the tenders themselves when we enter them. This isn't always an option for us just given what the customers want in terms of what's made public. But we'll keep you guys all posted as we -- at least as we make the sales and ship the instruments.

[Johan Unnerus, analyst]

Good. And our understanding is the tenders can be of various sizes and perhaps also take different period of -- take -- duration in terms of time could be different as well.

[Stuart Gander, executive]

Yes, that's right. We did communicate -- I mean, one we're very excited about in Italy, is the first regional tender of its kind. In Tuscany, we communicated that one. It's called the Estar tender. It's for 9 instruments. So -- that's a significant multicenter placement. We do expect to receive the outcome of that by the end of June. So that should be forthcoming. Hopefully, there'll be some others that also are in a similar time range as well.

[Johan Unnerus, analyst]

Excellent. And in terms of the demand and interest and progress among distributors sort of on that side...

[Stuart Gander, executive]

Yes. So a couple of notes there. We did host all of our distributors at our office in Uppsala and were able to talk through each of the markets in detail, which was positive to hear, as I said in my comments earlier, continued growing interest. We do expect to see some evaluation placements in other markets like France and the U.K. The U.K. actually has some experience already with ASTar, so now we're more talking about the commercial terms with U.K. customers. But in France, we expect to see some evaluation placements here shortly, which should turn into tenders and commercial opportunities down the road as well.

So I think the market is now turning. I guess, I would characterize France and the U.K. as being 12 to 18 months behind Italy, which was sort of what we anticipated initially. And given the time lines of tender process, we'll have to work through it but we're now seeing activity that's in line with what we anticipated previously.

[Johan Unnerus, analyst]

Excellent. And as you alluded to in the presentation, in Europe, it seems like you're expecting more of a rental model. Presumably, that will require less working capital and in the U.S. eventually perhaps more of a capital market.

[Stuart Gander, executive]

Yes. In the U.S., in at least my experience, is more balanced between the two. There will still be customers who want to use the reagent rental model. But U.S. health institutions on the whole and especially the ones that we're focused on initially tend to be larger and more capitalized organizations that are able to use their balance sheet potential to purchase this type of equipment and correspondingly then want sort of lower operational costs.

So we will sell the instrument in advance and then have a less -- a lower price for the consumable than we would in a reagent rental model. So I expect to see that more often in the U.S. even in the near term than in Europe.

[Johan Unnerus, analyst]

And also congratulations to the FDA approval and you're already in the process then of establishing reimbursement on the NTAP. Is it possible to give a flavor on the time lines that we can expect on that side?

[Stuart Gander, executive]

Yes, absolutely and thank you. The FDA approval can't be understated. And really, I have to pass on that congratulations to the team who really carried the ball through that process. So enormously proud of what the team has delivered there.

With respect to NTAP, so having secured FDA approval prior to the May 1 cutoff came just in time, it is our opinion that we have now achieved all of the criteria needed for NTAP according to the described requirements. That said, the CMS will review and make their final determination for NTAP funding in October. So we're confident that they will be positive but we'll not be able to say for absolute certainty until that October announcement.

And the NTAP funding would not go into effect until January 2025 and will be effective for 3 years from there. And this is well understood and is part of our discussions with customers in the U.S. So they're anticipating this and we're able to communicate these time lines to the U.S. and our view that we have qualified. So it's certainly playing into the calculations from customers on their expected end user cost.

[Johan Unnerus, analyst]

It seems like the October feedback from CMS will be important.

[Stuart Gander, executive]

Yes. We'll certainly come back around on that. At this point, I'm confident on a positive outcome but as I said, cannot be certain until it's signed and sealed.

[Johan Unnerus, analyst]

And you're also rather clear on the need to further improve the access to growth capital and financing. And presumably, the positive CMS outcome would be positive also on that side.

[Stuart Gander, executive]

Yes, I would expect so. And more generally, I think showing the growth in the U.S. market is important and probably for everyone on this call as well, right? But being active in the U.S. market also opens up to a different set of both institutional and investor profiles and it's something that we're certainly engaged with here.

So we're staying focused on our mission and delivering results as a team. But I'm confident that as we gain traction in the U.S. market, that will change the profile of Q-linea as a global -- truly global diagnostic supplier, active and successful in the world's largest and most important diagnostic market. So I think you're on to the right line of thinking there, Johan.

[Johan Unnerus, analyst]

And it seems like you are engaged in communications with potential U.S. users and centers already. Is it possible to provide any flavor on the level of interest at this stage?

[Stuart Gander, executive]

From customers?

[Johan Unnerus, analyst]

Yes.

[Stuart Gander, executive]

Yes. So I think it's safe to say that we've got a couple of a few dozen active customer dialogues already ongoing. Some of these, as I mentioned, were initiated prior to approval because we were engaging in that early access program environment but obviously, we're limited in the range of conversation we could have.

So it's really only been now, what, a month, that we've really been able to expand that discussion. But even within that period, I can see from the types of discussions and the number of discussions with the team that the reception is very positive. And I have to be cautious in terms of mentioning names of customers specifically and we will certainly do that as and when it's appropriate and approved by the customers.

But I guess I would give assurance to this audience that we are working with the major U.S. health care institutions, the largest of the integrated delivery networks, IDNs. We're in conversation with the major reference lab networks in the U.S. And these facilities, the top ones, they individually control dozens of labs. So the potential commercial impact from any one of those is very significant.

That said, obviously, these facilities have a lot of stakeholders. We're -- we've got a team in the U.S., very well experienced in managing those stakeholders and they're doing a very diligent and thorough job on engaging with the customers and walking them through. Some of these customers have now been able to see the instrument. The feedback we are receiving is very positive.

There is interest in the U.S., obviously, in what the next version of the menu will look like. Users in the U.S. can see the European menu and you can see it's got more combinations than the U.S. one. They understand how this works and it's iterative. The FDA has stringent clinical requirements for approval and we're confident we'll be able to get more of those in our next iteration of the menu.

So we're having that discussion with them. And as long as they are -- they can see that pipeline of further expansion of menu, I'm confident we'll see them taking on adoption of ASTar in the near future.

[Johan Unnerus, analyst]

Excellent. And also regarding the cost base, SEK 50 million per year, some 50% in R&D and 5% in some other overheads, in terms of reference point, you are clear that you -- this process will be completed during Q3. Presumably, you have already started. What about the Q1 as a starting point? I mean, some of the effect is perhaps visible already in the Q there. Go on, sorry.

[Stuart Gander, executive]

Yes. Christer, do you want to speak more to that?

[Christer Samuelsson, executive]

I can take that one. It's a good question, Johan. Starting point is always difficult to say. But we have communicated that we have already seen, we have some visibility already in Q1 for the cost savings. Not that much but still, we have some visibility. So with that said, you cannot take the Q1 average monthly operating result as such and then you take the SEK 50 million of that. That doesn't work like that but it's not too far away.

[Johan Unnerus, analyst]

Yes. So you're during the first quarter of that process perhaps.

[Stuart Gander, executive]

Sorry, Johan. Please, again?

[Johan Unnerus, analyst]

So you're -- perhaps you're in the early stage of that process and perhaps in the first quarter or something if you can...

[Stuart Gander, executive]

Yes, we are in the early phase, as you said, yes. But we will see the full effect from Q3 and onwards. Yes.

[Christer Samuelsson, executive]

Yes, there's some restructuring costs and so on. So it's not -- we look at this as the run rate effect. I would -- I guess, I would also add, Johan, that our job is never done here, right? We need to keep reshaping the organization and we're doing that actively. Obviously, Christer and I are looking very closely at the overall financial picture but working with the entire leadership team at Q-linea to make sure that we're constantly reviewing and evaluating where we're deploying resources and ensuring that, that's most efficient and having the best short-, medium-term return on investment.

So we will expect to see continued fine-tuning of the organization as we go forward. We want to continue to be able to invest into our commercial team and the resources needed to grow our sales. And that will have the consequence of us needing to find some space in our existing spending. Some of that is in terms of head count in very selective spaces but also doing everything we can on either discretionary or other forms of spending, as I mentioned, facilities and things like that. So we'll continue to review our P&L continuously and ensure we're deploying appropriately. So I think this is -- it will be a moving target through the year.

[Johan Unnerus, analyst]

Yes. And finally, from other side on Podler, which is now in a separate entity and you had a valuation on that to supporting equity. What about the prospects of refinancing that separate and perhaps even finding a commercial partner or somebody perhaps even going further than that within sort of 12 months.

[Stuart Gander, executive]

Yes. Maybe I can start with that and Christer, you can add on from a financing perspective. So strategically, yes, I mean this is -- there's a clear opportunity for Podler. From a commercial perspective, that one would benefit, as you suggest, from a partnership with a strategic who has the range and the ability to sort of link it into existing workflows since it's complementary in a number of ways also to the existing standard of care.

So we're continually exploring that opportunity. And also just from a investment profile, it's at a different stage than ASTar, which is now our focus. So it would benefit from a different type of investor profile to bring that one to market. So we are having those discussions. I wouldn't want to comment anything specific at this stage, just given where we're at in those.

I don't know, Christer, if there's anything you want to add in terms of the structuring of that now [indiscernible]?

[Christer Samuelsson, executive]

No, I don't think so. I think I've said before, the strength of the parent company equity, which is positive. Other than that, it's, as you said, discussions with separate financing. And we have shown now that Podler has a value, which is positive.

[Operator]

There are no more phone questions at this time. So I hand the conference back to the speakers for any written questions or closing comments.

[Stuart Gander, executive]

So no written questions as I can see it.

[Christer Samuelsson, executive]

Me, neither.

[Stuart Gander, executive]

Okay. So with that, I think we can close the call. Thank you all for your attention. I wish you all a great Friday and a good weekend.

[Christer Samuelsson, executive]

Thank you.