Biovica International AB (publ) (BIOVICB) Earnings Call Transcript & Summary

Welcome, everyone, to our interim report presentation. So if we go to the next slide, you'll see that it will be me and Cecilia Driving, our CFO, that will perform the presentation. And if we to the next slide after that, you'll see the agenda. So we'll start with -- or I will start with a short introduction of Biovica. We will go through the highlights for the third quarter in our fiscal year, which we're now presenting. Cecilia will walk through the financial and we will end with a summary and a Q&A where you will be able to ask us questions. And we also have had questions coming by mail before that I will start with. So that's the agenda for today. So if we move on to the next slide, just a very short background about the company, what we do. So Biovica develops and commercializes blood-based biomarker assays with the purpose to improve monitoring of modern cancer therapies, and I'll get that a little bit to how we do that. We do that through our assay, biomarker assay, DiviTum, that's for dividing tumor, which is an assay for measuring cell proliferation. And we have a strong clinical documentation that demonstrates the capabilities of the assays in order to do so. And the beneficial of this is, of course, the patients that can get feedback if they're on an effective treatment or not or otherwise can switch to [indiscernible] treatment, but also payers that -- or health care providers that are paying for these treatments and, of course, would like to have effective treatments for those great investments. So if we move on to the next slide, there's a schematic picture of how the method works in other products. So the technology is that we move with our assay, biomarker assay from a blood sample from the patient, can measure the enzyme, which is active in the cell proliferation process. So we actually -- it's very closely related to cell penetration. And as you all know, cancer is [ find ] by current controlled cell proliferation. So in many clinical trials, it's been evident that this correlates very well to the aggressiveness of the disease. It's very prognostic, but also during the treatment can give early feedback if the patient is responding to the treatment or not. In the picture, it illustrates how DiviTum works in connection with imaging, imaging being the standard method being used today for monitoring of the patients in the metastatic setting, where you compare size of the tumors before and during treatment, and that requires a couple of months before we can do that evaluation. And we've shown in clinical trial of DiviTum that we already after 2 weeks can get feedback if the treatment is efficient or not. So -- and that's for a simple blood test, which, of course, provides great benefits. And the product in itself is a kit where you mix regions with the blood sample from the patients, and where you get a readout and value of the cell proliferation rate that you can use for monitoring of the treatment. The product is developed in standard platforms, [indiscernible]. And yes, you can read more on our homepage about the technology and all the publications supporting its [indiscernible]. Moving on to the next one. We have a summary of the significant events during this third quarter in our fiscal year. The first bullet is for studies that was presented on the world's biggest breast counter conference and breast cancer being our focus area, so it's very important. This was something we went through pretty throughout the -- on the last presentation, so I will cover that more. But the other 3, I will cover the new 2 studies, both the U.K. one which also involves site in Sweden that has started and the Italian site both of these are within breast cancer, and I'll cover them on the next page. We've also had positive news from the FDA that they have resumed our FDA for 510(k) FDA application by end of January, and I'll comment a little bit about that process as well on the upcoming slides. And after the end of the period, we announced that the Karolinska University Hospital has published collaboration or a clinical trial that they've done on their PROMIX study, where they use DiviTum to get the feedback on treatment efficiency. I'll go through that as well on the coming slide. All right. Moving on to the next one. That slide covers the 2 new trials that we have communicated that we have started. These trials are both perspective trial. That means that we will be -- patients will be enrolled, followed over time and several DiviTum samples will be analyzed during the course of the treatment. So it will be an observational trial and give very important information both for the treatment oncologists but also for Biovica as a company. The first one in U.K. is performed by the Christie Hospital. It's 100 patients. It's CDK4/6 inhibitor, which is becoming more and more the standard treatment within hormone positive breast cancer, and it's our focus area for the product as well. And in that trial, they're assessing the hypothesis that you could reduce imaging. You're seeing serial blood samples with DiviTum and thereby this early detect resistance to this CDK4/6 inhibitor based on biomarker feedback. So this is sweet spot that we would -- are clinical utility, and we're very grateful for this trial. And similar with the TIRESIAS trial at Prato Hospital in Italy, where we have 150 patients that will be followed during their treatment. And it's the same kind of treatment, CDK4/6 inhibitor. And the hypothesis is that using biomarkers, DiviTum specifically, that you can make treatment decisions to offer best possible treatment for that patient -- for the patients. You can read more about this on the clinical trial. You have the NCT numbers with more information and details about the trial. This is also -- since we are looking to enter the European market, and these are key geographies. So it also adds, especially in the U.K. to our [indiscernible] network, which is really important. Moving on to the next slide. That was the PROMIX. That was PROMIX clinical trial that we announced the other week that it has been published, it's a collaboration with the Karolinska Institute and University Hospital. Since many years, the collaboration was actually initiated in 2013, and it's been involving a lot of oncologists, key opinion leader. So over 20 authors on this paper that has been involved. And the patient has been followed over 10 years. So it's a long follow-up after those initial blood samples taken and analyzed by DiviTum. This is interesting, yes, for that long follow-up, of course, and that we're being able to be -- can predict its outcome already 10 years ahead, over 10-year period. But also since this is outside the metastatic breast cancer area. This is locally advanced, where these patients get neoadjuvant treatment. It's interesting because it's an area where we are looking to expand after an initial introduction of the product within the metastatic area. This is the next step for us as we see it. And of course, having data supporting the value of the product in that area becomes then of course very important, and this will add another 30% to the market potential. And we have additional trials ongoing and will generate more data within this area, but it's, of course, a good first step. In this trial, we also -- when compared, this has been done before, but with today's standard way of measuring cell proliferation today, Ki67 market, which is a tissue-based marker. And of course, it's a great advantage that you can do the same thing with that lab-based marker, and we're able to see that the 2 markers correlated with each other. So that was the PROMIX trial collaboration with Karolinska, and we're very grateful to see those positive results. Okay, moving on to the next slide. As a summary of the FDA 510(k) application. And just to give you some background about that, the 510(k) clearance is required in order to launch the product for clinical use and market the product for clinical use in U.S. being the #1 market for us, our focus market, but also the biggest market. So it's really important process. And we submitted our application by end of September last year, and we got a lead reviewer signed, and we received feedback about a month later that the FDA had paused all the 510(k) applications that was not EUA applications. That means emergency -- using the emergency process due to COVID. So the FDA prioritized COVID assays and put everything else on hold including ours. Despite that, we got the feedback that we cleared the first target and were given the substantive review status by mid of November, but the applications were still on hold, and the lead reviewer was reassigned to other COVID-related processes. By end of January, we see very positive news as one of few applications. We were -- they were restarting hours. So we got a new lead reviewer assigned. And the substantive review has commenced again, so the process is moving forward, and we have interacted with the FDA and reply to all the questions given all the information that they have required. So that is good. And if it would be their normal time line, we would expect to have a decision before end -- before start of summer vacation. But FDA has given feedback, although we have started the process, we don't commit yet through our normal process and time line due to the COVID situation. So we have communicated externally that we are aiming for a decision before the end of quarter 3 this year. But this is -- we're very grateful that we're progressing, and it is really good. So that is the status update about the FDA process. Moving on to the next one. So the FDA process is not the only thing we do in order to commercialize the assay in the product in -- on the U.S. market, which is our immediate goal. There's a lot of ongoing activities, and here's a summary of some of those. 1 -- point 1, of course, is to strengthen the U.S. team that is performing a lot of this work. And the latest addition is Amy Williams. She was recruited from Novartis and she's located in Boston, started in February. She has a background at Novartis. Exactly within this deal, she has been working within breast cancer, developing breast cancer treatment from Novartis, including the CDK4/6 and part of the launch process for launching new therapies. So she has very relevant experience, long experience within oncology and breast cancer and this type of treatment [indiscernible] the network. So Amy will be working with our U.S. oncologies, which also will be our key customer important to reach out to. So that's very important for us, and we will continuously add additional key resources to the U.S. team. Another important area is the reimbursement and the pricing strategy, and we made progress there as well. We've developed a budget impact model targeted towards the payers. Based on the results that we have from our clinical trial program within breast cancer, and that data has now been compiling to this model, which will be presented at an upcoming health economy conference. It's already been submitted. And it will also be used in the upcoming payer advisory board discussion that is planned. So we're now starting to interact with payers in that process, in the reimbursement process. In parallel with that, we've had a January key opinion leader advisory board as well in order to get essential feedback that will be working to our messaging and the launching of the product. A patient advisory board to do the same thing for patient group is also being planned and conducted here in the coming months. So we're moving forward within that area as well. When it comes to commercial partnerships, I would say this is the area where we have been most affected by the pandemic situation. And that is because of the -- our proprietary partners, which is the laboratories in the U.S., the clinical laboratories, have, to a great extent, shifted focus for the last 12 months to do COVID testing to a very great extent and haven't had so much other focus. We see a lot of positive signs here as well, both U.S. in general, where their vaccination program is progressing really well, and the new President has set an objective that they should celebrate 4th of July as normal, They will be back to normal -- celebrate by then. And it seems like they might be able to achieve that, especially since they have now 74 million people that have received their first vaccination shot by now. So that is positive news for us as well because it frees up capacity on those clinical labs that we're discussing with. But also we made progress due to the results that we recently presented on San Antonio, the big breast cancer conference. And that's the fact that our FDA process has been restarted and also that we have some of our key opinion leaders that has been engaged and also helped us in that process. So we are progressing here as well. And our objective is to have this collaboration in place or this agreement in place when we get the FDA approval in third quarter. The last area I want to comment is sales to the research-use-only area. We cannot sell before [indiscernible], we cannot sell for clinical use, but we can sell the product for research use only, which we do. And we've seen an increase here from customers, and the customers are pharma companies primarily, pharma, but also academic centers were primarily pharma that are using the product during their clinical development, getting early feedback if the treatment is efficient both for new treatments or for existing treatments in order to expand into new areas where they combine it with other type of drugs. So the 2 orders, we got to see 2 rather large orders, but we shipped only partially this quarter. So we will continue to ship in the coming quarters. And one is a new customer and one is a recurring customer that has been using it for years. And we've also seen -- outside these 2 orders, we've seen an increased interest, several new pharma are now doing proof-of-concept trials that could also lead to additional orders going forward. So this is also a good sign that the results from the clinical trials that we've seen where we prove the value of the product is generating sales also in the research-use-only area. Although the biggest potential is, of course, the clinical use, but still this could also open up for partnerships with pharma, for example, companion diagnostic projects, which is our ambition as well. Yes. Moving on to the next one. Then we're going through the financial, and I will hand the word over to Cecilia.

Thank you, Anders. And I will try to pick up on what you just said about the sales in the quarter. As Anders said, we are in the research-use-only area. So right now, the customers are buying for research use only and during this -- for the clinical trials and using the kit with clinical trials. And we don't expect to get any continuous sales until we reach the clinical market. And that will be after launch. During the third quarter, we had SEK 1.4 million in sales. And for the 9 months, it's almost SEK 1.8 million. And most of the sales in the quarter is attributable to the first partial deliveries of 2 consumer orders that came in during the quarter. And it is 1 existing customer and also 1 new customer. And it's always very exciting to see the customers come back and new ones coming in. And I will switch over to the cash balance now. And we started the year with only SEK 40 million -- SEK 41 million in cash. And during the first quarter, we made a directed share issue on -- and after issue costs, we increased with SEK 141 million in cash and ended the second quarter with SEK 162 million. And after 9 months, we have SEK 155 million in cash, and we see that we are well capitalized ahead of commercialization in the U.S. and Europe, and the cash assets are sufficient for more than 2 years of operation, expected sales increase, not included in that. So we will -- we expect to increase sales after launch. And the expenses have been growing, but not that much yet, and they will, of course, grow more in the coming months when we add some more people in the organization especially on the sell side. The average number of employees is now 20 compared to last year's 16. And the increase is in line with what has been planned, actually slightly lower right now, but we will catch up. And I will hand over to you, Anders.

So I will just start from scratch on the summary slide because I don't know where I lost you. So yes, we have a product with great potential that can address an unmet need for personalized treatment within metastatic cancer in general and metastatic breast cancer specifically, which is our first focus area. And the potential for that first focus area is $400 million to $700 million. And the geographies are the U.S. market, the top 5 European markets including in the Nordics and the Japanese market. And the potential has been declined through market research, where payers have been [ induced ] for value and price sensitivity and oncologist has been into it for the process of using the product. Beyond that initial application, the locally advanced breast cancer, we think is a natural interesting next step, which will add about 30% additional, 30% to 40% market potential. And as you remember, the PROMIX trial that I presented early is an evidence of that -- that we have in our proof-of-concept area as well. And we are looking to expand into other cancer areas as well as step after that. I think we have a key, key strength with our collaborations with world-leading key opinion leaders and oncologists. And together with them, we have created a strong foundation with our clinical results. That will be the basis for the commercialization process that we are in the middle in, and it will be important for the regulatory process and for reimbursement and in the end, sales uptake. So the upcoming milestones to the cancer is the same that has been communicated before. We expect to have our 510(k) approval, and by that, do our U.S. launch the third quarter this year. And before end of this year, we expect to have our first reimbursement in the U.S. And we also before end of this year, launch the product on the first European geography as well. So that was the presentation, and I will now go to question and answers. And I think Cecilia, you had received some already?

Yes. We have received some questions, and I would like to take the opportunity to answer them here before we open for questions from the audience. And Anders, the first question is, what kind of competition will DiviTum TKa encounter in the field of monitoring on metastatic breast cancer?

Yes. Of course, very good question. And I think you have to understand what's being used there today. And currently, imaging is the standard method being used and also are in the U.S. guidelines. It's CT scan, [ full scans ], MRI and PET scans. Expensive technology, which has also great benefits with the other -- with -- in other areas than just only monitoring cancer. So here, we believe we have a strong value proposition with blood-based assays. That also was shown, can give feedback already after 2 weeks. And the normal procedure today is that you do these scans after 3, 4 months. But there are also blood-based markers out there. And in the guidelines today is within breast cancer, our CA 15-3, CEA, our predominant one. But still, they're not used stand-alone and they're not used in routinely, but sometimes used sometimes not. And here, we have, with the clinical data that we have generated and is still with the processes and with our clinical trials in the pipeline it will generate, we think we have a very good opportunity to outperform and become the standard blood-based marker for cancer monitoring. There are also others called CTC, or circulating tumor cells, but those have primarily been used within other applications, we don't see as a direct competitor. It's more for detection of recurrence -- early detection of recurrence rather than monitoring of treatments. And we also have a more straightforward and easier solution than CTCs in terms of complexity and general -- generic platform also. CtDNA is a similar technology in that sense that is also blood-based, and we're doing gene sequencing based on blood samples. Also [ very prosing ], and there's a lot of companies now with super high evaluation, although they're in the early setting as well as Biovica in the market. However, they are focused more on other applications like being diagnostic, that is finding cancer, identify, diagnosing cancer, being predictive that is giving information before treatment. And also during adjuvant treatment, early phase where you have removed the tumor surgically and then follow using ctDNA to see if there's recurrence basically. So we don't see those of competitors within the monitoring field either. They haven't focused on that. And I think we have some pretty significant advantages within that field because we don't require near as much blood volumes than ctDNA. There's not many -- you have to build a lot of volume to be able to do those analysis. So with DiviTum, you are only required a fraction of that. And we also have cost advantages in case of those. And the last category would be other central operational assays. And I think the major one is Ki67, as I mentioned. And also as you saw in PROMIX trial, we correlate with that with a great advantage that we are blood-based and not biopsy-based. So within the monitoring field, which is also one of the strong reasons why we have targeted that field, we believe that we have really strong position competition-wise.

Okay. And we have another question for you, and that is if interventional data is needed for commercialization.

Yes. No, we don't believe so. Maybe we should first start to define what is interventional data. So interventional trials or interventional data is when you are using -- you're acting on the outcome of the assay. And we're already doing observational trials, which is to -- example is [ 2, 5% here ] that has been initiated, and there's more to come in that area as well. So those and with the combination of the data that we already have, we believe, is a great starting point for say, quite a few of the payers in the U.S. we expect to accept the data that we already have. But if we're going to reach the targets that we have set up, that is to get 15% of the total market potential 3 years after launch, we need to complement with interventional data as well. And hence, we are working -- we're in discussion, and we'll be presenting those collaborations as well. So no, it's not required to commercialization, but it will help us reach the targets that we have set out.

Thank you. And now we will hand over on open up -- to Keith and open up for questions.

[Operator Instructions] And our first question comes from the line of Rickard Anderkrans of ABG Sundal Collier.

So first here, you mentioned in the report that you received orders from pharma companies using DiviTum when developing new cancer drugs. Is this an area you expect that will increase significantly once the FDA clearance is in place potentially here? Or are these European customers? How should we think about that opportunity going forward?

Thank you for your question. We think the 510(k) approval is important also in regards to pharma, and it's a quality stamp, so that we can take the assay through regulatory approval. So especially with that opportunity -- that opens up the opportunity to do partnership projects. That's what we're looking into, which is Henrik Winther's background and that with the objective that it should eventually lead to companion diagnostics collaborations. And because the pharma partner is the risk associated with the diagnostic test, it's important that the diagnosis partner has a track record of being able to get the product through the regulatory process. So that's why that's an important milestone in that collaboration in that setting with pharma. I don't want to speculate if this will increase. Yes, over time it well, but we haven't made an estimate that we communicated. Are you happy with that answer, Rickard?

Yes. Yes. Sure, sure. And you spoke a little bit about it, but expanding DiviTum's indications or intended use from monitoring to prognostic. How long do you believe that process will take? And is that more competitive setting or more commercially challenging setting would be interesting to hear as well.

Yes. Okay. That's a really good question. First of all, the first expansion to be clear here, is we see that we're still in a monitoring session -- monitoring category. Because even if we go to locally advanced breast cancer, for instance, like in the PROMIX trial, we're still monitoring. So we're still in the monitoring space. If you go into, for instance, local breast cancer, we would then enter into the more prognostic area. And we have also data from to date, 2 different trials within that setting of over 800 patients, so we had data on that area as well. However, then you run into a high level of competition, as you said, then you would be head to head against, for instance, Oncotype DX and MammaPrint and those prognostic assays within breast cancer, which has been very successful. And I think there's a great demand for that kind of a product here, especially as Oncotype DX is not available in Europe. However -- and we have the advantage that we are using it on a blood sample, not on biopsy. So yes, it's interesting, but it's one step further away. And you should, of course, realize that the competition is tougher than in the monitoring area.

Sure. Sure. And you spoke a little bit about it regarding potential for interventional study here with the DiviTum. Can you communicate on the time line when you can expect such a study to be started? And can you also communicate potentially how long such a study would take to perform in your estimates currently?

I will -- yes, I can give you a rough estimate. We are in discussion on that kind of trial already, so you can expect to see it during this year, at least. And time for that is that it will take, I don't know -- I should be a little bit careful there. We need to have enough results basically and, on average, it takes 2 years for 50% of the population to progress. So it can take maybe 2 years to summarize the results just based on those facts. Yes. So we think this is the normal way of doing it for diagnostic companies because like if you -- Oncotype DX, as an example, when they launched it, they launched without international trial and it complemented because you would like to get your cash flow going and then with -- complement with the interventional trial to further strengthen your value proposition and increase and yes, getting market shares as well. So yes, I think that's best practice to do that as well and not wait for everything to be in place and then launch. And I think also this -- yes.

Yes, sure. And just a final question from my side. Could you please clarify the commercialization path and perhaps a status update between the ELISA-based test kit versus the QPCR-based test kit, just to get a sense of that process as well.

Yes. Okay. So the ELISA kit is the one that we have now submitted to the FDA. The application is based on a ELISA kit. So we have the PCR, qPCR-based kit in our development process. And already now, we are seeing that to correlate well. So you can -- we expect to be able to do bridging trials to show the correlation. So we can benefit of already having a cleared ELISA product on the market. So we could say that our ELISA product could then be our predictive device. So there are several advantages with our PCR platforms for the user over time. One is that it shortens the reaction time and it shortens the hands-on time a lot. And it opens up for measuring multiple biomarkers once we can further develop this product to add biomarkers, especially interesting in the pharma collaboration area to develop new products, collaboration with pharma, where you add biomarkers which is more specifically tailored towards the mechanism of action for that drug. So yes, the PCR product has advantages, but the ELISA product is a really good start for us. And the ELISA products can also easily be automated on the -- yes, like the [indiscernible] ELISA platform, we would [indiscernible] ready, and that will take us far, and we can have the PCR product over time and gain some further advantages.

Our next question comes from the line of Niklas Elmhammer of Redeye.

Just regarding putting your -- getting the clearance in Q3 and performing the launch. Can you tell me a little bit about your activities? And how much you said you were adding personnel? And how much you can add this year?

Yes. We have previously communicated that we foresee a team of about 10 people in the U.S. by the end of the fiscal year, and we still stick to that plan. So the last -- the latest addition is Amy. She has a kind of a combination of a scientific and commercial profile being a PhD within this field, but also a lot of experience from Novartis launching this kind of product. So a great position. What we will be adding is more commercially focused [indiscernible] resources. So that is the next step. And we will announce that pretty soon. And still the objective of about 10 people organization by end of this fiscal year? Sorry, yes, the next -- I think in a year roughly from now is still our objective.

Okay. And for -- also include -- what about for the Europe and for other regions?

Yes. Yes. And the plans to expand there as well that we will enter the first European country by -- before end of this year. And so we can also expect to see commercial resources being enrolled for that path as well.

Okay. Great. I was also -- you published the results from the PROMIX study. Was a little bit curious just to -- these are promising results, but I was a bit curious about how you see the use in chemotherapy setting, the TK1 behaves somewhat differently here?

Yes. Yes, that's really good as you point out because that trial was on chemotherapy. So it's still -- I think it's still very valuable because it proves the concept in that locally advanced study. And it's actually a repeat we've had from U.S. trial from, for example, Washington University that [indiscernible] was also on a local advanced setting. So now we have repeated that U.S. trial was on CDK4/6, but this was on chemotherapy and older type of therapy. So we see that the big opportunity here is when the CDK4/6 treatment is moving into that locally advanced setting, especially since we are so strong than the metastatic setting, and we have a lot of data from that, and we're building with more results going forward. And we expect to see the CDK4/6 in it to expand into that field as well. And the -- there's a difference between CDK4/6 and chemotherapy because CDK4/6 lowers cell proliferation or PK levels from day 1 if they are effective, but chemotherapy that is not actually -- inhibit cell growth, it kills fast-growing cells. And you get a spike, like with many biomarkers. So with TK, you get an initial spike. The more cells being killed, the more TK is released to the blood stream. And that is actually also indicative if the treatment is efficient or not according to the PROMIX results. Did you understand that? Or was it too complex, Niklas?

No, no, no. I think yes, you explained that...

You can use that spike. But if you -- over time, that spike wash out, you will see that lower cell proliferation is a good prognostic indicator. So from that, there's many reasons why we focus on CDK4/6. One is that it's more and more becoming the standard treatment. The other one is that it's better suited because you don't have to think about those spikes. It's very straightforward. It's a reduction in cell proliferation measured by TK, it's good feedback. And the -- of course, the last [indiscernible] those -- these treatments are priced at very high levels compared to standard therapy.

Our next question comes from the line of Dan Akschuti of Pareto Securities.

So there were already a lot of good questions before, but I have a follow-up on kind of the commercial strategy in the U.S. So it's a great catch that you have there with Amy Williams from Novartis. And I think that is something we see that is often a bit underestimated or, let's say, not done well in the beginning. And I think your setup is quite good, but how do you come to the [ 10 FTEs ]? And would you consider building maybe a bigger -- or a stronger, bigger force there to really ensure a fast market uptake since you do have incredible data sets already. So I don't think you need any more data to convince anyone of the utility of your test, but I think you need probably the push into the clinics you already are in contact with and also others.

Dan, thank you for the question. See if I can break it down to a few questions. First of all, when it comes to our organization, yes, it's not -- we're not certain that 10 is our end state. 10 is where we are aiming for by end of this fiscal year that we start in beginning of May. So in April next year, we are aiming to -- for such an organization, and about 50% of that will be commercial profiles, and the rest of the organization, the other 50% will be like Amy, scientific and commercial in combination. And that could be also experienced within reimbursement and being able to engage with oncologists and payers and so on, so. And then, of course, if it can accelerate sales. It's -- we'll be investing in a big organization. But this needs to be done also in collaboration and we plan together with our partner. We haven't signed partner agreements. We should be careful to commit to details because this is something we need to plan and work out a strategy in combination with our partners and also have sales resources that will be an important factor when selecting the partner. So that was the -- was that -- is that okay for your staffing?

Yes. That's okay.

Yes. And then it's good that you appreciate Amy's profile. Yes, I agree it's just all super. I'm super happy for that recruitment and the experience that she brings is fantastic and the personality.

And another question. So it's great to see that you're preparing for launch and also at the same time preparing for the expansion and the -- what you showed on Slide 7, this is kind of building on the NHS -- this NHS study on the Pfizer Mayo Clinic study that you have already published of 55 patients, where you showed that you could detect [ 80.6 days median ] earlier than by RECIST criteria. So are you just building kind of the -- do you think you need that? Or is it just kind of opportunistic as there is a demand for the test since it kind of showed that already in...

Which one are you talking about on Slide 7? Is it...

NHS study on Slide 7.

Yes. Because -- okay. Yes. Going back, and basically, you say that the evidence you already have is convincing, and I agree. But I think this slide is really strengthening our evidence and yes, also the discussion with the interventional trial. This is very close to interventional trial. This is observational. So we'll get important data. And you could say that we have -- when it comes -- if you're going to -- or come our health economic model that we will be presenting later, we have 2 value drivers, you could say, or value levers. The first one is to reduce imaging, and the second one is to reduce futile therapy. And basically, in the NHS, the Christie trial they're looking a lot to reduced imaging and in the Italian trial, they're looking if we can push CDK4/6 inhibitor forward to second line, so -- and they're using TK as part of that decision process. Not that they will make those decisions, that's why we don't call interventional, but they will have different arms. So we will get information about TK baseline and the values and from the different arms that we can get the essential information for both those 2 very important areas for us. Is that helpful?

Yes. Yes.

So this actually has, and we will be taking more samples than ever before in these 2 trials, some serial samples for patients. So it will add to our data a lot.

Okay. And in [ March, the CMC, ] so did you manage to expand your lab facilities and the [indiscernible], did you the upscale the [indiscernible]? Or did you kind of just add second and third device to do that and to kind of ensure that you can really supply the commercial -- to get the commercial supply to a level that allows to -- yes.

Yes. The sound is little, but I think I repeat the question, see if I understood it correctly. So I understand the question is we are prepared for a launch in terms of supply of kits and production process and so forth.

Because I remember, you had only 1 [indiscernible], I think. I think that was a while ago. But I'm just curious if you have installed more than that or if you're about to or if you're going for a big one and concluded the process development for that so that you can ensure supplying the commercial demand.

Okay. So we still only have 1 facility. And -- but we're, at the moment, very happy with that. It's also a cost aspect. And we work with our processes, so we have developed our products, but also our production processes as part of the FDA submission process. And we also expect the FDA to visit us to audit our processes, so we're ready for that. And so that's kind of the quality aspect. When it comes to the volume aspect, we are convinced that with our current facility, we can meet the volumes that we expect in the coming at least 18 to 24 months in acquiring this facility. However, we don't have a failover capability in place. It's a single point of failure in some basis. And in order to mitigate that risk, we will manufacture, so we have kits on the shelf. So we will overproduce initially. And then over time, we will add a second production line so we have failover. And we can also both increase volumes and increase uptime service levels. So yes, we're following our production plan as -- yes, as we have made them out.

Okay. And when could we expect the second production line to be functional? And yes.

Well, I have to come back to you on that, but it's not within -- it's more than 12 months' away. And, yes. With [indiscernible] also in line with the plans that we have because we -- it's -- to set up a new line, it takes some lead time to get it operational.

Yes. And regarding that ...

Yes. But that's also just to add, the -- it's -- and that's also the reason why we are keeping production in-house. Because it is cost-efficient and very good margin-wise to keep it inside. And we can produce large volumes in our current facility. And it's also a way for us to protect our IPR.

Yes. Fully agree on that. And one more question on the FDA approval. So to kind of gauge it a bit, have you received some questions that you could answer to kind of -- I think that is always helpful to see a bit how how much they are working on your application? And then if you can expect it in a normal time line already in May or if it really becomes a bit later? So do you see them to be active, do you receive some smaller questions that you can answer? And...

Yes, they've been very active initially. And we got some questions, which we were pretty quick to return because it was more -- it was not that they're expanding into any new areas. They just wanted to drill down into more details into that, that we already submitted. So that was pretty safe for us to come back to that. So they're not doing their review on their hands. So.

When did you get the last question, if I may ask?

That was pretty shortly after they announced that they had restarted the question. There will be -- and then they communicated that now we will be doing renewal on our side for quite some time. So there, we don't expect them to come back yet. So it's in line with what they have -- the feedback they have given us.

Okay. It shows that they're active. One last question. I'm not sure if it was covered by the first analyst asking questions, but from the sales that you reported now, can you see in which indications the pharma companies are trying to use DiviTum? And is it in other indications that you are aiming at right now?

Yes. It's a mixture. Sometimes we have very little inside. Sometimes, we have actually been -- entered agreements, which is fully in sight. And in between, where we like the price results that were published, presented after completion of the trial. And so yes, it's a mixture. It's both within breast cancer, the new drugs. And it's also outside breast cancer for new drugs or existing drugs to expand.

Do you see a potential then also for you to go after these indications?

Yes. And I think it's a very attractive model as you can do that in partnership with pharma. Yes. And I think with the regulatory process now moving forward, plus the experience that we have with Henrik and the customers that we have, we have opportunities that we, of course, need to explore.

Thank you. We have no further questions. I'll hand back to the speakers for any further and final remarks.

Well, thank you very much for all the good questions and the interest for our interim report and bye-bye from Anders and Cecilia.