Ladies and gentlemen, welcome to the Biovica International Teleconference Q3 2020 2021. For the first part of this call, all participants will be in a listen only mode. And afterwards, there will be a question and answer session. Today, I'm pleased to present CEO, Anders Rylinder and CFO, Cecilia Driving. Speakers, please begin.
Thank you very much, Keith, and welcome, everyone, to our interim report presentation. So if we go to the next slide, you see that it will be me and Cecilia Drilling, our CFO, that will perform the presentation. And if we go 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 Baivikka. We will go through the highlights for the Q3 in our fiscal year, which we're now presenting.
Cecilia will go through the financials, and we will end with a summary and a Q and A when you will be able to ask us questions. And we also have had questions coming by mail before that we'll start with. So that's the agenda for today. So if we move on to the next slide. Just a very short backhaul about the company, what we do.
So Baivika develops and commercialized 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 strong clinical documentation that demonstrates the capabilities of the assets in order to do so. And the beneficiaries 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 an effective treatment, but also payers that are in 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 and how the product.
So the technology is that we move our assay biomarker assay from a blood sample from the patient can measure an enzyme, which is active in cell proliferation process. So we actually it's very closely related to cell proliferation. And as you all know, cancer is fine by a chronic 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 a treatment, can you give early feedback if the patient is responding to the treatment or not. In the picture, it illustrates how digital 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 trials with Visiting, they'll be already after 2 weeks, can get feedback if the treatment is sufficient or not. So And that's for a simple blood test, which, of course, provides great benefits. And the product in itself It's a kit where you mix regions with the blood cell for the from the patients.
And then you get a readout value of the self proliferation rate that you can use for monitoring of the treatment. The product is Development of standard platforms, it's easy to implement. And yes, you can read more on our head homepage about the technology and all the publications supporting it there. Moving on to the next one. We have a summary of the significant events during this Q3 in our fiscal year.
The first bullet is for studies that was presented on the world's biggest breast cancer conference and breast cancer being our focus area. So it was 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, well, both the UK one, which also involves sites of Sweden that started and the Italian study, both of these are within breast cancer, and I will cover them on the next page. We've also have positive news from the FDA that they have resumed our FDA for 510 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 PROMISE study, where they used Dibitum to get 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 prospective trial, that means that we will be patients will be enrolled, followed over time and several Dimitrium samples will be analyzed during the course of their treatment.
So it will be an observational trial I'll give very important information both for the treatment of ecologists but also for Baidu as a company. The first one in U. K. Is performed by the Christie Hospital. It's 100 patients.
It's CDK4six inhibitor, which is becoming more and more the standard treatment within pharma 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 using serial lab samples with dividend and thereby, the thirdly detect resistance to this CDK4six inhibitor based on biomarker feedback. So this is a sweet spot that we would our clinical utility, and We're very grateful for this trial. And similar with the Pfizerias trial at the Tata Hospital in Italy, where we have 150 patients that will be followed during their treatment. And it's the same kind of treatment, CDK4six inhibitor.
And the hypothesis is that using biomarkers, Did it come specifically, but you can make treatment decisions to offer best possible treatment for that patient for the patients. You can read more about these on the clinical trials. You have the NTP numbers with more information Some details about the trial. This is also since we are looking to enter the European market and these are geographies. So it also adds, especially in the U.
K, to our key opinion in the network, which is what's really important. Moving on to the next slide. That was the Promix that we promised the 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 to keeping a 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 lab samples taken and analyzed by digital. This is interesting, yes, for that long follow-up, of course, and that we're being able to be I can predict outcome already 10 years ahead over a 10 year period. But also, since this is Outside the metastatic breast cancer area, this is locally advanced where these patients get newly adulant 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 trucks ongoing, and we'll generate more data within this area, but it's, of course, a good first step. In this trial, we also where comparatives have been done before, but with today's standard way of measuring cell proliferation today, TI-six fifty seven marker, which is a Fischer based marker.
And of course, it's a great advantage that you can do the same thing with that lab based marker. And we were able to see that the 2 markets correlated with each other. So that was the PROMEX trial in 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 application And just to give you some background about that, the 510 clearance is required In order to launch the product for clinical use and market the product for clinical use in U. S. Being the number one 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 510 applications that was not EUA applications, that means emergency from due to the emergency process due to COVID. So the FDA prioritized COVID assets and put everything else on hold, including ours. Despite that, we got the feedback that we cleared the first toll gate and was Given the substantive review status by mid November, but the applications were still on hold, and the lead reliever was reassigned to other COVID related processes. By end of January, we received very positive news. As one of few applications, we were were restarted hours, so we got a new legal 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 question, given all the information that they have required. So that's Good. And if it would be the normal time line, we would expect to have a decision before end yes, before start of summer vacation. But FDA has given the feedback.
Although we have started the process, We don't commit yet to 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 seems 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 the on the U. S. Market, which is our immediate goal, there's a lot of ongoing activities, and here's summary of some of those. 1 in Q1, of course, is to strengthen the U. S.
Team that is performing a lot of this work. And the latest position is Amy Zillians. She was recruited from Novartis, She's located in Boston. Started in February. She has a background at Novartis, Exactly within this field, she has been working within breast cancer, developing breast cancer treatment from the markets, including the CDK4six and part of the launch process for launching new therapies.
So she has very relevant experience, long experience with oncology and breast cancer and this type of treatment and keeping it in the network. So AIM will be working with our U. S. Oncologists, 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. As 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 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 their reimbursement process. In parallel with that, we've had, In January, the opinion leader advisory board as well. In order to get essential feedback, Yes. Then we'll be working to our messaging and the launch of the product.
And 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 the 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 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 30 or 74,000,000 people that have see their Firstx Nature 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 The SKZ conference, and that's the fact that our FDA process has been restarted. And after that, we have some of our key opinion leaders that has being engaged and also helped us in this process. So we are progressing here as well. And our Objective is to have this collaboration in place or there's a preliminary phase where we get the FDA approval in 3rd quarter. The last area I want to comment is sales to the research use only area, we cannot sell before 510 ks Flu, 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 in from customers, And the customers are pharma companies, primarily pharma but also Acadianxentes, but primarily pharma that are using the product During their clinical development, getting earned feedback if the treatment is sufficient, Both for new treatments or for existing treatments in order to expand into new areas, whether combined with other type of drugs. So the 2 orders, we've got received 2 rather large orders, but we shipped only partially in this quarter. So proof of concept trials that could also need 2 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 only area. Although the biggest potential is, of course, the clinical use, but still this could also open up for partnerships with pharma and for example, comparing diagnostic projects, which is our ambition as well.
Yes. Moving on to the next one. Now we're going to 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 phase for clinical trials, inducing the kit for clinical trials. We don't expect to get any continuous sales until we reach the clinical market.
And that will be after a loan. During the Q3, we had SEK 1,400,000 in sales. And for the 9 months, it's almost SEK 1,800,000. And most of the sales in the quarter is attributable to the first partial deliveries of 2 on 2 major orders that came in during the quarter. And it is one existing customer and also one new customer.
And it's always very exciting to see that come back and new ones coming in. And I will switch over to the To the cash balance now. We started the year with only SEK 40,000,000 SEK 41,000,000 In cash, during the Q1, we made a directed share issue on and after issue costs, we increased with SEK 140,000,000 in cash and ended the second quarter with SEK 162,000,000. And after 9 months, we have SEK 155,000,000 in cash, and 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,
We apologize for this technical difficulty. We'll play hold music until we have resolved the issue. We thank you for your patience. We now have the speakers back online, and the call will now resume. Thank you.
Anders, please go ahead.
Thank you. I don't know what happened. I was in technical issue there. So I'll 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 the 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 $400,000,000 to $700,000,000 And the geographies are the top 5 European markets, including and the Nordics and the Japanese market. And the potential has been defined through market research, where payers has been in view for value and price sensitivity. And oncologists has been entered 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 that's you remember the COMEX trial that I presented earlier is an evidence of that that we have in our food costs with that area as well.
And we are looking to expand into other cancer areas as well as a step after 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 So that will be the basis for this commercialization process that we are in the middle in. And it will be important for, yes, the regulatory process and for reimbursement and in the end, sales uptake. So the upcoming milestones to the Q4 is the same as being communicated before. We expect to have our 510 approval and by that, do our U.
S. Launch the Q3 this year. Before end of this year, we expect to have our first reimbursement in the U. S. And we also, before end of this year, launched the product on the first European geography as well.
So that was the presentation. And I will now We'll now go to question and answers. And I think Cecilia, you have received some already.
Yes. We have received some questions. 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 DIVIDTA and CK 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 been used there today. And currently, imaging is the method being used and also are in the U. S.
Guidelines. It's CT scans, toll scans on MRI and PET scans. Expensive technology, which has also great benefits with other with in other areas and just only monitoring cancer. So here, we believe we have a strong value proposition with blood based assay that also always 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-fifteen-three, CEA are the dominant one. But still, they're not used stand alone, and they're not used routinely. They're sometimes used sometimes now. And here, we have with the clinical data that we have generated is still with the processes and our clinical trials in the pipeline 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, where circulating tumor cells, But those are primarily being used within other applications. So we don't see as a direct competitor. It's more for detection of recurrence early detection of recurrence rather than monitoring of also very promising and there's a lot of companies now with super high valuation, although they're in the early setting as well as bioweetcan on the market. However, they have focused more on other applications like being diagnostic, that is Finding cancer, identify diagnostic cancer, being predictive that is giving information before treatment and also during adjuvant treatment, the early phase, when you have removed the tumor surgically and then follow using cpn8, see if there's recurrence basically. So we don't see those of competitors within the monitoring field either.
They haven't looked 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 in gptDNA, there's not many we had really a lot of volume to be able to do those analysis. So we did it on you are only required a fraction of that. And we also have cost Advantages, okay, those. And the last category would be other pro circulation updates.
And I think the major one is Ki-sixty seven, as I mentioned. And also as you saw in the TROMICS trial, we correlate with that with a great advantage that we are not based on a biopsy base. So within the monitoring which is also one of the strong reasons why we have targeted that field. We believe that we have a really strong position competition wise.
Okay. And I 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 asking on the outcome of the assay. And We're already doing observational trials, which is the 2 example is the 2 trials percent here that was been initiated and there's more to come in that area as well.
So those and with the combination On the data that we already have, we believe, is a great starting point for sales and 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 If we get 15% of the total market potential 3 years after launch, we need to complement with interventional data as well. Hence, we are working we're in discussion and we'll be presenting those collaborations as well. So no, it's not required to comment on commercialization, but it will help us reach the targets that we have set up.
Thank you. And now we will hand over and open up to Keith and open up for questions.
We will now begin the question and answer
session.
And our first question comes from the line of Richard Anderkrans of ABG Sundal Collier. Please go ahead. Your line is now open.
Good morning Anders, Cecilia and Mattias. And thank you for taking my questions. So, first here, you mentioned in the report that you have 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?
Hello, Richard, and thank you for your question. We think the 510 approval is important also in regards to pharma, and it's a quality stamp sort of that we can take the asset through regulatory approval. So especially with that opportunity that opens up the opportunity to do partnership projects that we're looking into, which is Hendrik Winters background. And that with our objective, I think, should eventually lead to comparing the diagnostics collaborations. And because the pharma partner is the risk associated with the diagnostic test.
It's important that the diagnostic 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 it will increase. Yes, with time it will, but we haven't made an estimate that we've communicated. So are you happy to answer it, Ken?
Yes, yes, sure, sure. Thanks a lot, Anders. And you spoke about a little bit about it, but Expanding dividend indications or intended use from monitoring to prognostic, How long do you believe that process will take? And is that a more competitive setting or a 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 the care 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 COMEX trial, we're still monitoring. So we're still in the monitoring space.
If you go into points of local breast cancer, you would 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. We had data on that area as well. However, then you run into a higher level of competition, as you said. Then you would be head to head against, for instance, Oncotype DX and NamaPrint and those prognostic assays within breast cancer, which has been very successful.
And I think there's a great demand for that kind of product here, especially as Soltopax DX is not available in Europe. However, and We have the advantage that we have using it in a blood sample or 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. Thanks a lot, Anders. And you spoke a little bit about it regarding potential for our 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 study would take to perform in your estimates currently?
I will yes, I can give you a rough Rough estimates, we're in discussion on that kind of trials already. So you can expect to see it in during this year at least. And time for that is That it will take, I don't know, I should be a bit careful there. We need to have enough in dams basically. And on average, it takes 2 years 4%, 50% of the population to progress.
So it's going to 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 also type the Exo again, as an example, when they launched it, they launched without international trial and they complimented because And you would like to get your cash flow going and then with the complement with the international trial to try to strengthen your value proposition and increase, and yes, getting market shares and so on. So yes, I think that's best practice to do that as well and not wait for everything to be in place and I mean, a launch. And I think also this yes.
Yeah, yeah, sure. And just a final question from my side. Could you please clarify the commercialization pass them, pass them perhaps
Especially interesting in the pharma collaboration there, Tubular Food 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 really good. Easily be automated on yes, like the Teekin in my platform we've updated that already and that will take us far and we can add the PCR product over time And again, some further, I'll just
Sure. Thank you very much for that Anders. Have a great day and thanks for taking my questions.
Thank you, Vikram.
Thank you. Our next question comes from the line of Niklas Almhammer of Redeye. Please go ahead. Your line is now open.
Yes. Hello. Thank you. Regarding where you are getting the clearance in Q3 and Can you tell me a little bit about your activities and how much you said you were adding Personnel, 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 latest addition is Amy.
She has a kind of 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 geore resources. So That is the next step, and we will announce that pretty soon. And there's still the objective of about And the organization by end of this fiscal year sorry, the next, I think, in a year, roughly from now is still our objective.
Okay.
And for also include what about the Europe and some other regions?
Yes. Yes. And the plan still stands there as well that we will also be the 1st 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. Thank you. I was also You published the results from the PROMEX study. Yes. But just a little bit Joris, just to these are promising results, but I was a bit curious about how you see the Use in the chemotherapy setting, TKM1 believes somewhat differently here.
Yes. That's really good to point out because that trial was done on chemotherapy. So It's still I think it's still very valuable because it proves the concept in that locally advanced setting. And It's actually a repeat we've had from Eurostrasse from, for example, Washington University with CELTI MREL was also on the local advanced setting. So now we have repeated that U.
S. Driver was on CDK4six, But this was on single therapy and older type of therapy. So we see that the big opportunity here is when the CDK4six treatment is moving into that locally advanced setting, especially since And we're building with more results going forward. And we expect to see the CDK4six Energia expanding to that field as well. And The there is a difference between CDK4six and chemotherapy because CDK4six lowers cell proliferation or PK levels from day 1 if they're affected.
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 PK is released to the bloodstream. And that is actually also indicative if the treatment is sufficient or not according to the COMEX results.
Did you understand that or was it the CapEx limit, sir?
No, no, no. I think, yes, you So you can
use that spike, but if you over time, let spike wash out, you will see that lower cell proliferation is all is a good prognostic indicator. Yes. Okay. So yes, yes. Great.
Thank you. Yes. So from that, there's many reasons why we focus on CDK4six. 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. If the reduction is self proliferation measured by TK, Good feedback. And of course, the last one I refer to, but the Health Economy, those These treatments are priced at very high levels compared to chemotherapy. Okay. Thank you.
Thank you.
Thank you. Our next question comes from the line of Dan Ashokti of Pareto Securities. Please go ahead. Your line is now open.
Hi, everyone, and thank you for taking my questions. 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 the markets.
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 bit 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?
Hello, Dan. Thank you for your question. See if I can break it down to a few questions. First of all, it comes to our organization. Yes, it's not we're not certain that PEN is our real estate.
PEN 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 profile. And the rest of the organization, the other 50% will be like AIM, scientific and commercial in combination. And that could be Also, shares within reimbursement and being able to engage with the oncologists and payers and so on.
So And then of course, if it can accelerate sales, It's we will invest in a bigger organization, but this needs to be done also in collaboration and the plan together with our partner. We haven't signed our partner agreements. We should be careful to commit to DeepCo because That's something we need to plan and work out a strategy in combination with our partner, but also have sales resources. That will be an important factor when selecting the pocket. So that was the was that is that okay for Your staffing?
Yes. That's yes. Okay. Yes. And then we good that you appreciate Aenis profile.
I agree Super, super I'm super happy for that recruitment and the experience that she brings is fantastic and the personality.
Thank you. 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
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 Then 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
Which one are you talking about on Slide 7? Yes. Going back to and basically you say that the evidence you already have is convincing, and I agree. But I think these trials 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. You could say that we have when it comes if you're going to overcome 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 energy, And the second one is to reduce futile therapy. And basically, in the 8 NHS, the CRISPR trial, They're looking a lot to reduce imaging. And in the Italian trial, They're looking if we can push CDK4six inhibitor forward to second line.
So and they're using PK as part of that decision process. Not that they will make those decisions. That's why we don't call it intervention, but they will have different arms. So we will get information about Teekay baseline values and from the different arms, so we can get the potential information for both those two very important areas for us. Is that helpful?
Thank you.
Yes. So this I actually
add and we will be taking more samples than ever before in these two trials, so serial samples for patients. So it will add to our data a lot.
Okay. Thank you. And Tidmar, it's CMC. So did you manage to expand your lab facilities and the live affiliated? Did you upscale the light release data?
Or did you kind of just add the second and third device to do that? And to kind of ensure that you can really supply the commercial to get the commercial supplies To a level that allows to yes.
Yes. The sound is a little bit, but I think I repeat your question, see if I understood it correctly. So I understand the question if we are prepared For launching tariffs and supply of kits and production process and so forth.
Because I remember you had Only one live facilitator, 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 bigger one and concluded the process development for that so that you can ensure Supplying the commercial demand.
Okay. So we're still on the HyHoone facility And but we're, at the moment, very happy with that. It's also cost aspect. And we have worked with our processes, so we have developed our product, but also our production processes as part of this 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 in the coming at least 18 to 24 months in our quality control facility. However, We don't have a failover capability in place. It's a single point of failure in some cases. 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 2nd production line, so we have failover, and we can also both increase volumes and increase uptake service levels. So yes, we're following our production plan Well, I have to come back clear on that, but that's not within it's more than 12 months away. Okay. Yes.
But that also in line with Yes. But also just to add, we're 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 much they are working on your 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 they can answer?
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 want just wanted to drill down into more detail into the ARS that we already submitted. So that was pretty simple for us to come back to that. So They're not doing their review on their hand.
So where did you get the last question, if I may ask?
That was pretty shortly after they announced that they have restarted the investment, the review. Okay. Thank you. And then they communicated that now we will be doing renewal on our side for quite some time. So they we don't expect them to come back yet.
So it's in line with the feedback they have given us.
Okay. Thank you. 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 dividend? And is it in other indications that you are aiming at right now?
Yes. It's A mixture. Sometimes, we have very clear insight. Sometimes, we have actually been agreement, which is full insight and in between where we like the Pfizer results that were published presented after completion of the trial. So yes, it's a mixture.
It's both within breast cancer from 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 if 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 in 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 will 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 entering report. And