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6/18/2024
Hello everyone and welcome to the Bioweek Q4 and the year end report. And here's our forward looking statement disclaimer. The presenter for the webcast today will be me, Anders Weilander, the CEO, followed by Anders Morin, our CFO. Then Hector Tamburini, head of US operations, will present the US development and also Henrik Vinter responsible for our pharma businesses area. And the agenda we will go through is our standard agenda. We'll start with a short introduction for people that are not so aware with our business. Then we'll move into the fourth quarter and the highlights and Anders will follow and give a financial update. Then Hector will do the US update. Henrik will do pharma services update. And then I will summarize and we'll move into the Q&A session. And for the Q&A session, we will have our three equity researchers, analysts from Pareto, from Kempen, and from Redeye that we will let in. to the meeting to ask questions directly. But all of you that are listening into this webcast have the opportunity to post questions that we will do after the analyst session. And we'll ask as many as we can until we break at 4 o'clock the latest. If you want to post anonymous, you can do that. But then you have to check that checkbox. So if you're worried about our company BioVica and our product Divitum. So Divitum stands for dividing tumor. We measure cell proliferation by measuring a very important enzyme active in the cell proliferation process, which is called thymidine kinase. So it's very much so the core of cancer as cancer grows through uncontrolled cell proliferation. This has proven to be a very effective method, both to be used prognostically before a start of treatment, for example, but also an excellent way of monitoring patients being on cancer treatments as a change in cell proliferation indicates whether the patient responds or not to the treatment or if the treatment is effective, I should say. test is blood-based which allows for simple and quick analysis and we've also shown that we can provide information month ahead of the standard method being used today which is imaging this conclusion and and the documentation lies on a very strong foundation and solid ground with over four 30 peer reviewed unpublished scientific articles. The majority of the documentation is within the breast cancer area with about half of those publications and over 3000 patients. And it's done in combination with and by world leading academic institutions and key opinion leaders, which of course is very important for us to communicate the message in a trustworthy way, which also reaches out to other oncologists. In US, we have several well-renowned collaboration partners of which we have published with the majority of these. We have the Mayo Clinic, we have WashU, Washington University, Johns Hopkins, Baylor College, etc. In Europe, we have both Karolinska, the Institut Curie, etc. and the Prato Hospital in Italy that has done several collaborations and publications. We also have a breast cancer group in Europe with IBCSG, a big international group covering several companies in Europe and also with a small group in the US. We get an excellent reach for the data that we have been publishing. If you look at the market potential. We've focused initially at the breast cancer area and within breast cancer monitoring of metastatic breast cancer. The two markets that we are focusing on is the US market where we go to market with a CLI model where we offer the test as a service and in Europe we have focused on the bigger countries and the Nordics Our focus on the go-to-market model is through partners that we sell kits and they provide the go-to-market service, including setting up labs, taking us through reimbursement, etc. We focus on partners that have a sales force with oncology that can meet the customer and generate demand. The market potential is based on, in US, an average price of $400 times the number of patients being on treatment for this disease. And as Hector also will see, this assumption seems to hold very well now when we also are on the market. We have Great potential outside of the metastatic brain cancer area to expand and become a standard method of evaluating treatments within cancer, especially within the targeted treatments area where you target the cell proliferation cycle. And one example of that are the collaborations we're doing with pharma. to support them to develop new therapies and also have the opportunity to co-develop new products complementary to new therapies. This generates value both for the pharma companies as well for patients and for the healthcare providers. Henrik will talk about this process in his part of the presentations. And looking further down the horizon, we have other indications that we have identified, and we also have started to generate data. One good example is the metastatic malignant melanoma, where we have data published and also an IP process going, which we'll report and give an update on. And then also interesting areas are prostate cancer and non-small cell lung cancer. If we go into the fourth quarter that ended end of April, so February to April for us, as we have a broken fiscal year. I want to highlight some areas, all our three major areas, US, private services and Europe. I think we made great progress. we did not reach our 10 million sales goals in total, which we're of course disappointed with. But despite that, we see a great progress in all these three areas. And if we start with the US area, we see that the trend that we reported in the third quarter, we are really getting momentum and we see that the revenues grows and we get new oncologists ordering from new institutions and the number of patients are growing. So here we see a really, really strong trend, which we think is very, very encouraging. And this is something also Hector will dive into a little bit more. Same thing with pharma services. Here we've seen the trend for some time. And if you look at the year-on-year and the Q4 revenues, we also are developing that very well in a good direction. And also we have some awesome that Henrik will elaborate a little bit on. And also in Europe, we have two strong partners, which we have a great belief in. Palix in Spain got a good start as we were presenting data with the GACAM group at ASCO. GACAM is the Spanish breast cancer group. That is the one that is defining guidelines, et cetera. Important key opinion leaders to work with in order to introduce the test on the Spanish market. In the Nordics, we have an agreement with Axelab, and we also see that they are moving forward. They go to market work, and they have hired two sales reps that soon will be starting, and they are dedicated on working with Divitum. So progress in Europe as well. If we go into the actual highlights that we have communicated during this fourth quarter, The first three one on this page is related to our pharma services, the two master services agreements that we signed and also that resulted in work orders related to those master service agreements. So this is an evidence of the progress we're making within the pharma services. Another thing within this or related to this area is the patent process that we have to expand our patent specifically for immunotherapies. And this opens up a new area for collaborations with pharma that has a very large potential, even larger than the CDK4-6 inhibitors that is our current focus. If you look into the US area, in addition to the positive development when it comes to the revenues and the number of oncologists and institutions and patients, et cetera, we also are seeing a greater interest from oncologists to study this further and include patients in both interventional and observational trials. This has great value for us. The intervention trials will help us to drive demand and the observation trial is more local trial. The Mayo Clinic also creates awareness and also as this being standard of care treated patients, it contributes to our revenues. We did announce. cost saving and restructuring program at the end of the quarter, which will give savings of 30 millions per year or 25% of our costs. And I'll go into that on the next slide. Finally, after the end of Q4, We communicated that we are together with GACAM, did present the result at ASCO. We've been active at both ASCO and AICR and both at these two large conferences, ASCO being the largest one within oncology. We've received, it's been very successful in terms of creating awareness and also establishing new relationships with pharma companies that has led also to progress when it comes to sales and agreements, which Henrik will dive into a little bit more. Yeah, the cost reduction program, I'll give you some background around that as well. The implementation of that led to a reduction of 10 employees, five in the US and five in Sweden, and rationale for doing that was to lower the cost levels and to address some performance issues. We did not meet the goals and of course that has consequences. What we focused on was reducing overhead staff and instead also we have kept high performers with customer facing roles. that has also been promoted and has taken over management responsibilities now. The result of this is that we have achieved a leaner and more effective organization, which we believe will be performing very well. And we've seen also that the sales, the remaining sales staff, we kept out of the customer facing staff, we kept four out of six. uh we are performing we're doing our best months here uh at the end of the quarter four and the beginning of of uh first quarter uh at the the current fiscal year so um yeah it's always sad to say uh goodbye to colleagues uh that has uh served as well and be very loyal and performed well but uh i think with this we have strengthened our position and going forward significantly Overall, this will give us a 13 million per year cost saving. Uh, and, uh, the majority of that is in the U S organization. Uh, it's also an 8 million Swedish in the restructuring costs, which, uh, was, uh, booked at, uh, the fourth quarter for, uh, fiscal year 2324. With that said, I touched upon some numbers, but I will hand it over to our CFO, Anders Morén, who will go through the financials. Anders, please.
Thank you. So, a few slides on financials.
You can see here our Total year sales ended up at 7.3 million. That's a miss versus our 10 million target that Anders was talking about. We're of course not happy about that. But if we look down at the Q4 sales, that was 1.9 million. That's 225% growth versus Q4 prior year. And for the full year, it was 115% growth versus prior year sales of 3.4 million Swedish kronor. So we are going in the right direction, a little bit slower than anticipated. We zoom in on the US IVD sales, the same pattern here. We sold 423,000 Swedish kronor In Q4, that's more than the year-to-date number for Q3, 365. So it's more than what we had sold year-to-date when we closed Q3. Total sales, 788,000 Swedish kronor. And this good trend, I think Anders mentioned, that continues now we see also in May and June. So we're quite happy about the trend. A slide on the cash position, 79.4 million Swedish kronor when we closed Q4. Rounding up with a look at the net operating cash flow by quarter, it was minus 25 million in Q4. Of course, the 8 million restructuring cost that we accrued for in end of q4 because that was the decision was taken on the 23rd of april so we accrued the 8 million that also inflates both the working capital and operating cash flow before changing working capital but net minus 25 million so that's basically in line and we we have the plan is that that should be improving us as our cost saving reductions comes in and also a sales start coming in following the trend that we just saw on the previous slides. Headcount, we were average 37 heads for the full year. As of May, we're down then to 27. So it's 20 headcounts in Uppsala and seven in US. So that's minus five on each of the sites that we are operating in and all in all 30 million saving, I think, about 25 of those 30 comes from the US restructuring and 5 million coming from the Swedish side restructuring. So with that, I'll hand over to Hector that will walk us through the US update.
Thank you, Anders.
Good morning, good afternoon, everyone. My name is Hector Tamarini. I'm the head of the US operations based in San Diego, California. Just as a brief summary of my background, I'm a clinical biochemist by training. I worked alternatively in diagnostic and pharma companies for over 30 years now. Joined BioVica in 2023 and have managed the CLIA laboratory in San Diego and more recently expanded the role to the oversight of the whole U.S. operations. I'm going to share with you the overview of the last quarter of the year from the perspective of U.S. operations. So next slide, please. Yeah, that's the agenda. We're going to review the sales performance, take a look at the reimbursement status, regulatory outlook, our clinical trial activities, and some of the use and benefits of the real-world patient data that we have accumulated at the moment. Next slide, please. Thank you. So the sales performance, as you already heard some information, the revenues grew over 100% over the past quarter of the year. We noticed 16 order institutions, which is four more than the previous quarter. So we keep adding prescribing institutions, which is a very positive indicator. The number of patients also grew about 50% over the past quarter. And one thing that we noticed is that more patients are having multiple Divitum tests over a period of time. And that's a key indicator for us because it kind of describes how the prescribers use the test. Initially, they select specific patients or cases where they feel DIVITUM can provide some good information about the therapy, and once they become familiar and comfortable with the results and the correlation with the treatment, they expand to other patients, and even more, they expand to other professionals within the institution. So that to us is a key success factor of the market expansion of the test. Next slide, please. Regarding reimbursement status, we are very satisfied with the fact that on all three fronts, Medicare, private insurance, and client bill claims, we have not had any denials due to medical necessity or clinical utility. And as Anders mentioned before, we are aiming and confident that we can get a blended channel reimbursement rounding the 400 US dollars, which is our expectation, probably higher. Next slide, please. That would be the regulatory outlook. You know you heard before, probably from my colleagues that we've had several in audits and certifications. not mentioned in the chart, but we also host audits by our pharma customers. And the reason why they're important is they keep us at a very high industry standard. You know, they follow international regulations, so we are in compliance. We pass them. And right now, the next big milestone will be the New York State Department of Health inspection, which is scheduled sometime in the second half of the year. We've been in communication with the inspector and it's just a matter of them scheduling the audit and hopefully after successfully meeting their expectations, we can obtain the permit that will allow us to serve and offer Divitum in such an important state as New York.
Next slide, please.
We mentioned before the existing clinical trials, some that started recently at Yale University and Washington University. We added two more recently, one with hunter done blood and. cancer specialist. It's an observational clinical trial, very reputable institution in New Jersey, and also we're working very closely with Mayo Clinic of Jacksonville, Florida, also in an observational clinical trial, both of them aiming to improve the efficacy of the treatment and the use of Divitum as a tool for the physician in the management of therapy. um i think we can go to the next slide please and previously we have presented several real world or real patient cases where we see the use of the clinical utility of divitum this has a continuous happening and it has multiple effects in our potential for grow sales at least in the u.s One of them, as I mentioned before, is the word spreading or the knowledge sharing among colleagues and in certain institutions. We've seen that already happening and that has rendered amazing results when we started seeing a significant number of prescriptions from some physicians. There's a tool that we implemented very recently, which is the advisory boards, and this is key opinion leaders sharing their experience, their knowledge, and their use of Divitum in the management of the therapeutic regimen of their patients. This is extremely helpful because it's not just the company speaking, it's also a peer who tells how they use Divitum, how Divitum has helped them manage their patients, and it's very well received. And we hope that we can continue doing that with multiple professionals, and that will also create a sense of community of how these tests can help them and help their patients manage through the course of the disease. and another very important factor which is also resulting from the recent restructuring is to center the focus on very large institutions with multiple specialists multiple oncologists multiple locations and that includes many of the idns or integrated delivery networks among which in the US we have HCA Healthcare Kaiser Permanente Ascension Health Mayo Clinic. And the reason for our interest in focusing on these institutions is they manage a very complex and critical sense of treatment management, optimization of the treatment, as well as health economics. And that's a benefit, for almost everybody involved because you know they they benefit from optimizing the use of therapy and dv2 can be a very good tool in that process so with that i'm gonna hand over to my colleague henrik thank you all right thank you very much hector
so i only have a couple of slides but i'll take you into the pharma service world and what we're doing here at biobican so as you can see the first slide here it might be a little bit busy slide and hench you know allow me to uh you know provide with some background and also remind you or refresh your minds on on what kind of activities we'd have within this part of our business so this is about um onboarding pharma companies, working together with pharma companies. Initially, we offer our TKA service testing and also kit sales for pharma. This is in order to create trust in our biomarker assay, but also create trust in our company. And then when farmers are really convinced that this biomarker can make a big difference for them, we continue into CDX or into collaborations at least. And part of these collaborations are CDX collaborations. And then finally, out of the CDX collaborations, we will have a product that is going to be owned by Vika and sold by Vika. So that's the process. we're going through with the different farmer partners. It's a stepwise approach, as you can see, and here. And you can also see from the cartoon here that this stepwise approach have different value components tied to each of the steps. If you look at the status or the outcome of Q4 on the service and the kit sales today, we have at the end of Q4, we had a work order book at 11.6 million Swedish. At the end of Q3, we had a work order book at 8.5 million Swedish, so a significant increase. And then remember, as you will see below, But actually during Q4 also executed on 1.4 million Swedish. So you can see a significant increase in the web order book during Q4. Also Q4, we made two new MSAs that was mentioned by Anders. And we actually also have two MSAs in negotiation currently. And when it comes to the CDX collaborations, we have ongoing discussions. We have actually initiated our first pilot study, which is up running now. If we dive into the numbers, and this is just to show that we really had a strong Q4 and also a strong year-over-year revenue growth. If you compare Q4 last year to this year, we had 135% increase. And this just tells us, because we've seen this Q4 with pharma has been slow over a couple of years, but it seems as if we have now really convinced pharma to work together with us and hence we have turned our Q4 into a strong Q4 as compared to earlier. On the year-over-year revenue, we had almost 80% increase as compared to last year. So also there, we are happy with the financial performance. If we dive a little bit deeper into some of the highlights and what are the key progresses over Q4, we have mentioned we signed two new MSAs. One was with a Tier 1 pharma company. And the other was with a tier three pharma company. And we have earlier defined a tier one company, a pharma company, as a company that has, you know, above, you know, 10 million U.S. dollars, 10 billion U.S. dollars in revenue per year. And a tier three pharma company we have defined as a company that has below one billion U.S. dollar in revenue per year. So we've signed, you know, one in both ends there, which we're really happy with. We also signed three new work orders and actually one of those were the biggest we've ever had so far. It was a work order above 2.2 million Swedish. We concluded our lab and process preparations that will enable us to start two major work orders. And these activities I'm kind of referring here to prepare is logistics and it's also data transfer agreements, getting those in place. So we have them now all in place and we expect to have the first batches of samples arriving end of this month here. So we're really happy to move into the big studies because that will allow us to have a robust shipment of samples on a monthly basis. Then we initiated negotiations on additional two MSAs, and we actually, outside the Q4 and here in June, we signed one of those. And the other one is in progress. I expect that one to be signed within the next three, four weeks. Then we also, as I mentioned before, we initiated a pilot study with a new pharma partner, and this was, you know, using our assay as a stratifying, patient stratifying tool. So this is as a CDX tool. And we obviously, you know, super excited about this. And I can't share any data currently, but we will, of course, you know, as soon as we can and in agreement with our pharma partner. Otherwise, we had this positive feedback from the EPO, the patent office in Europe, about a PCT application we made last year. And this is using our assay monitoring tool within immune checkpoint inhibitor drugs. This is a huge market potential that we expand into by using our our assay in this regard. I think currently the CDK4-6 inhibitor market globally is around 50 billion Swedish. But if you look into the immune checkpoint inhibitor market, it's probably five, six times as big as that. So that really unlocks a huge market potential for our assay. Then lastly, we've had some successful meetings or presentations at AACR and NASCO, both internal data, but certainly also data presented by Pharma. And this is what is now establishing new collaborations and this is going to be the foundation for our Q1 and further Qs in this fiscal year here. And we have Already in this week, we have meetings with a couple of new pharma partners that are really excited about the data we presented at those two meetings. So overall, a really, really strong performance in Q4 and over the year within the pharma business.
And with that, back to you, Anders. Thank you, Anders, Hector and Henrik.
So I'll just summarize and we'll open up for Q&A. So I said in my introduction, we have a product that measures what's really core in cancer, the cell proliferation, and it's easy and convenient with a simple blood sample. And we have also shown in an extensive clinical documentation that we have strong evidence for the benefits of using our assay and the benefits are both for patients as well as healthcare providers and pharma companies. The foundation we laid with the clinical evidence is the foundation that we base our commercial efforts on. to unlock that huge market potential. We start with metastatic breast cancer in the US as the clinical focus, and also in Europe using partners. We had a little bit slow start, but now we believe that we really see the flywheel start spinning, which is heavy in the beginning. But now we've got momentum, especially in the US, And the process, like Hector said, the oncologists are curious, interested. They try it out in small numbers on maybe difficult patients. They see the benefits and they're increasing the orders, monitoring quite a significant part of their patients, if not all. and they become regular customers and supporters and starts to communicate this to others and this way we can accelerate the uptake and that's where we are now the two advisory boards that has been really successful and it's driving that accelerating that process so uh after some uh time we see that the flywheel was a bit heavier maybe wanting to start up but now we have the momentum pharma services is super interesting such a huge potential and we are also expanding that portfolio and i guess the big milestone would be the first collaboration for a project with pharma And with the cost reduction program, we have also made a more effective organization, taking out 30 million Swedish kronor per year in cost. Of course, that's important for us, 25% of our total cost base. So we continue with this to strive against our very important target of becoming cashflow positive, And our ambition is to achieve that second half of 2025. And I was, because we have broken fiscal year, to be very clear, a calendar year when we're saying that. So with that said, we're moving into the Q&A session. And I'd like to start with our analysts. And I think we should start with Chen from Pareto, which I know is online. Maybe you could unmute yourself, Chen, and please.
Hi, good afternoon. Can you hear me?
Yeah, very well.
Yeah, perfect. So I have a few questions. Could you tell us a bit more about the progress of the new U.S. go-to-market strategy? Is there some sort of timeline and
kind of terms can we expect would that be a more front-loaded or back-loaded agreement thank you yeah as uh hector touched upon uh we we have a uh the slightly change uh of focusing on not just 10 uh client build contracts we see that we can we can generate uh get paid basically uh both inside the ones that we've gotten from Medicare and from private payers. So instead, we chose to focus on the ones that really can leverage the uptake of the dividend. And where we have received very great response and interest are from those large IDNs that has a strong financial incentive to push the product out so we get help in pushing this out to oncologists. So that's our primary focus. Hector touched about that. And that's also the first one we expect to be able to communicate that we can assign. Secondly, since we now have reduced our sales force from six to four customer facing, which I must say those four still perform very well and drive sales in a great manner. Over time, of course, we would like to be able to expand the sales force without driving our need for capital too much. So we have also investigated the opportunity to partner with an external partner at the US market uh that has sales force that we can utilize and then share revenue uh we uh are not we expect that to take a little bit longer time and we'll keep you updated on that there is interest but we haven't found the match yet okay perfect yeah that's actually also my fault questions because as you mentioned you are retaining most of the sales force so
We can still assume your Salesforce will take care of part of the commercial activities and the other part will be maybe licensed or partnered out to the commercial partner. Is that correct?
Yeah, see if I understood your question. Yes, so we've been able to reduce the Salesforce, but we've been able to increase the sales since then. So yeah, I don't know if that was so we continue to work on with the sales we have, and we're able to expand the use of Divitum and increase sales in parallel with looking on other value leveraging activities like partnerships, deals, and both with IDNs and outsourcing partners. So the work is done in parallel. Was that the answer to your question?
Yeah, yeah. Oh, thank you. Thanks for taking my questions.
All right, thank you, Jen. Should we move on to Louisa?
Hi, yes, thank you for taking my questions, Tim. Maybe to start off, could you perhaps expand a bit on which factors do you believe contributed to Divitum sales not reaching the guidance that you provided earlier?
Sorry, Louisa, I didn't hear the beginning of your questions. Say again. I lost you there in the beginning. Can you repeat the question? I don't hear you now.
Oh, yeah.
Now you're unmuted. Please. Okay. Thank you. Yeah, I hear you now. Sorry.
So I was just wondering if you could expand a bit on which factors do you believe contributed to the dividend sales not reaching the guidance that you provided earlier? I'm guessing it's a combination of more than one, of course, but if you could explain a bit.
The main factor is the longer uptake time in US. I think we underestimated the time for that process that both me and Hector explained that typically an oncologist, when we generate interest, they try it out, they increase the volume and they start communicating to peers. And that's how we get the flywheel going. We've seen that work very well in the last couple of months here, especially. But the timing, it has taken longer than we thought. On the other hand, now we have, it's like rings on the water. Now we have more oncologists talking to more oncologists. So we hope on an exponential growth from here on based on that.
Makes sense. And which, if you know, which is now the average number of David Toon tests that are being ordered in the US per patient? I mean.
Oh, do you know that by, do you know that? Hector, I don't know that to answer it, but maybe you can give some guidance at least, Hector.
Yes, I can help with that. So in general, we see at least three to five tests per patient. Usually, if it's a new patient that starts treatment, you'll see a baseline test, which is prior to initiating therapy. At the beginning, there is more frequent testing, which coincides with a visit to the specialist. And hopefully, if they respond to the treatment well, then they start spacing out the visits and the treatment, similar to the image diagnostics that are used traditionally in solid tumors. But that's pretty much what we've seen with the majority of patients and doctors.
I think it's a little bit difficult to because patients that has been on, we have a significant increase as Hector said in a slide last month or so. Of course, those patients, we only see the first test for the new patients. But if you look a couple of months back, you see that the When they're used for monitoring, which they are typically after testing it out, are starting to use for more or less all of their patients, they are coming back monthly to follow up on that patient. And we see actually sometimes even two and once or twice, three times per month. But I think you can assume that the guidance that we have given, that the test will be used monthly for patients being on CDK4-6-enabled treatments, especially the first six months, and then quarterly until progression, and then new treatment monthly again initially. I think that seems to hold based on the data that we have so far. you would like to see a little bit more data over time to really give a precise comment on that. But it looks good so far.
Thank you. That was actually very helpful. And maybe just one last question. Could you elaborate a bit more on the presentation and the results at ASCO? Because I feel like that was quite remarkable presentation. So if you could just expand a bit more on that.
Yeah, I'll leave it over to Henrik will switch seats and he will give a little summary of that.
Yeah, thank you. Yeah, so at the ACR meeting there, you know we had our own. Yeah, OK, only yeah, just going to say no at the ACM meeting we had, you know our own presentation and a lot of you know attention around that by farmer at the ASCO meeting. It was not our data presented. It was data presented by a farmer partner farmer company. I probably can't mention it right here. because I have not, you know, I'm not aligned with that pharma partner on, you know, mentioning it out here, you know, at an investor call. But that at least attracted a lot of attention from other pharmaceutical companies and has now triggered a lot of conversation, additional activities with that current pharma partner plus additional activities with new pharma partners. And that is also involved in one of the MSAs that we are currently discussing.
And also the, you know, I think also the GACAM Flickr trial.
Oh, yeah. The GACAM Flickr, that's outside, you know, my area. That's the clinical development piece. That was obviously also a very important trial presented. And that's into our core business and not the least, I guess, European sales. Very important. Yeah.
So if I fill in there, Henrik, the Flipper trial, that was the PR also. So it was both pharma partners that we did a PR, and then the Flipper trial, which we PR'd, that was performed by the GECAM, as I said, the group in France, the French, in Spain, the Spain Breast Cancer Group. And it was the monitoring of patients that was on the CDK4-6 inhibitor on treatment for breast cancer. I think you can, if you, you will find, uh, if you, uh, look for gate camera, flip a trial, you'll find it both on clinical trials and, uh, the ASCO, uh, information. Hope that helps.
Yes. Thank you so much for taking my questions. That's all. All right. Thank you very much. We have you on an ears from red eye. Yeah, you can hear me.
Great. Okay. I have a few questions. It's obviously important to, with the reference sites on the clinical testing, I think you have activated, was it 14 or 16 accounts? How many of these would you refer to as important sizable reference sites?
That's a good question. Hector, can you elaborate on those? How many would you consider as important reference sites of these 16? I think I could start and then I hand it over. But most of those are well-renowned NCCN and NCI centers typically. And like Hector mentioned on that slide also, we have the Mayo Clinic trial. That's one of the examples. That was the oncologist on the ad board. And we have also a few in the Arizona where we had a client bill agreement also. And then we have a couple of additional ones that are, I would say, in the eastern center, eastern part of US, that are well-renowned NCC and NCI centers. I don't know if you have a more precise number, Hector,
uh like you can get is it i i think you described it well uh anders i i believe out of the 16 institutions we we see probably there are top five if you want to round up the number that are uh large um some academic organizations and that carries a heavy weight because uh you know the the way the word spreads uh within the institutions we've seen that even with one case that you know, makes a mark in one physician, then all of a sudden we see the propagation of the interest in DD2. So I would say probably the top five are the most relevant, but all of them are important to us. Yeah.
And then just to give you some perspective also, Johan, the reason for it is that's the way it is. It's also due to our sales targeting strategy. So we have data and made an analysis on where are the largest prescribers in terms of CDK4-6 inhibitors. Those are the ones that can benefit most over assay and also most potential for BioVica. So those are the ones that we have been targeting and we've also been prioritizing NCCN and NCI centers where we have relationships and from our clinical program, that is quite a lot. So we have a head start on those institutions. And so when you see the orders comes in, it's primarily from those big ones that we also have been targeting.
And is it possible to say a thing regarding the outlook and the activity coming for the rest of 24?
Yeah, yeah.
If we it was cut off, I think I heard so. Can we get some guidance for the outlook of 24 and I guess also to end up 25 when we are talking about that break even milestone, which is so important to us. So in order to so we need to have aggressive sales goals for the fiscal year 24-25 to get to the break even by second half then of 25. where we previously announced 50 million SEK per quarter, now with a cost reduction that is around 20-25% lower. So we've lowered the bar, but it still requires significant growth to get there. But still, I think we've laid a very good foundation, both when it comes to US and pharma, where we see the growth. And to go back to your previous question, we have one or two, typically one or two key opinion leaders per those big institutions. So there's potential now when they're starting to share their patient cases and success stories with Divitum to grow within those institutions. And we also are negotiating and, and, uh, are talking with, uh, partners, new partners that, uh, will help us to push them out to, um, yeah, to a big population. So that is, uh, the strategy short term for 24, 20, 25, uh, which is required for us to, uh, be able to, to, uh, to, uh, achieve that aggressive growth rate in revenues.
In order to hit that sales level of just below 40, then, is it possible to say anything regarding the mix, clinical versus pharma-related contribution and sales services?
Yeah. We believe that the majority of the revenues will come from the US business. uh slightly followed uh by the uh uh pharma services business and then uh a small contribution from the european business so that will be the smallest one that when we're working through partners uh it's also we started uh the go to market we signed the deals but then to some extent it's it's uh also dependent on the progress in u.s with patient success stories and and yeah assets that we developed in u.s so
europe will be the smallest contributor of the three and earlier you alluded to around 10 million in cost base per month after this restructuring what sort of level can we expect as a run rate yeah so then you can expect a 25 reduction so yeah slightly below uh eight million uh cost base and then of course uh revenues add on top to reduce uh negative cash flow yes and finally then um on the farmers side um this pilot testing is interesting of course is it possible to give any flavor for for timelines i'm thinking about it yeah switch and you get some gallons
Thanks. Johan, it's obviously difficult to give exact timelines. It is ongoing. But it's also very obvious that before pharma is jumping into such a conclusion of making a CDX, they really want to make sure they have the right data. So that's why it's still ongoing, and they are collecting more samples. We're testing more samples. So I really have a hard time currently to give any clear guidelines. It really depends on the results. So far so good, but it, it, it depends on, you know, the final results. And so also the decision, you know, from farmer to move into it. So I, I would, you know, not say more than that currently.
Yes. And the prospects of, uh, an additional master service agreements is of course also interesting. And maybe that's a decision has taken slightly lower in the partner organization. Presumably you will press release when that is a fact. Yes. Yes, absolutely. Absolutely. Thank you.
Thanks. I want to say, Henrik, it's fair to say also that in our plan to reach that break-even milestone, we are including our first co-development project, so it's smart, but we're dependent on external factors, so it's difficult to forecast exactly and promise, but I think it's a good sign and a good step that we are now doing pilot trials and we also have a portfolio because it's a little bit of a numbers game the probability of course increases when you have a portfolio and several discussions because not every pharmaceutical becomes goes to market and goes all the way so so that's why it's important to build up that portfolio that Henrik and his team has done But with that said, I'd like to thank you all for the great interest and the great questions you post. And I wish you all a great summer. And we're looking forward to communicate the process that we expect to have going forward. Thank you very much.