Hello everyone, and welcome to the Biovica Q1 Interim Report. Today, it will be me, Anders Rylander, together with my CFO, Anders Morén, and Hector Tamburrini, Head of U.S. Operations, and Henrik Winther, Head of Business Development and pharma Services, who will be presenting. And the agenda will be a short introduction about the company. We'll focus on the Q1 highlights. Anders will go into the financials, Hector will give an update about the U.S. progress, and Henrik will do the same for pharma services. And at the end, there will be a summary, and we'll open up for a Q&A session. The way the Q&A session will work is that first, we will let our analysts, financial analysts in, which you see here on the screen, Johan from Redeye, and we have Pareto and Luisa from Kempen also.
You can also submit questions in the chat window, and if we have time, we will try to limit this to one hour. We will answer these questions from the chat as well in the webcast, and all questions that we can answer, we will also answer in writing and add it as an appendix to the presentation that will be uploaded after the meeting, so if I start with a very short introduction of Biovica, what we do. We have our product DiviTum that measures cell proliferation. Cell proliferation, of course, is essential for us humans, and it's also a hallmark of cancer, how cancer grows.
DiviTum has shown to be an excellent tool, both before start of treatment to provide prognosis of how aggressive the treatment is and how the outcome for the patient will be, but also, and that's our focus area, to be an excellent monitoring tool for patients being on treatment. This is something there's a great demand and need for, being able to provide better monitoring for patients currently being on treatment. We have data showing that we can provide a shorter time to progression.
We're talking weeks rather than months, and of course, that's beneficial for the patient, that more quickly can get a confirmation that they are on an effective treatment or, if not, that we can do something about it, for instance, change those or even change treatment. This is something also that's been highlighted by the FDA, that has initiatives, like the Project Optimus, that wants to turn the standard from maximizing the tolerated dose, to the most efficient treatment. And, for such a scenario, you need efficiency biomarkers for monitoring, just what we can provide with DiviTum. So we have a product that can provide excellent value, both for patients being on treatment, but also healthcare providers and also for health economics, because treatments within this area are priced at more than $10,000 per month in patients.
So of course, using those resources well is essential also for health economics. So this, what I'm saying, has been proved in many clinical trials. Over 30 at this point has been published. In these trials, more than 5,000 patients been included, and the majority is in, within our initial focus area, which is the breast cancer area. These clinical trials has been performed by some of the leading institutions and oncologists in the world. In the U.S., we have Mayo Clinic, Dana-Farber, Washington University, and Johns Hopkins, for instance, Baylor College. Those are all examples of institution and oncologists that we have been working with to perform these clinical trials. And in Europe, we also are working with leading institutions and breast cancer groups.
This is, of course, important because that's an excellent way for us to get the message across from these leading oncologists that present the data on, as keynote speakers on conferences, et cetera. The potential for the product is very large. In this example, we are focusing on the metastatic breast cancer area, where we are currently focused in our commercial efforts in U.S. and in the major countries in Europe, including the Nordics, is our focus area. We are also active supporting pharma. Pharma can benefit from using our product, DiviTum, when they develop new treatments within cancer. It's, of course, important to getting the feedback whether the treatment is efficient or not, and you can use it as input for designing and following up on clinical trials.
Our ambition is to extend these collaborations into co-development projects, resulting in new products tailored complementary to new treatments, so-called companion diagnostics. This is an area that will be covered by Henrik Winther in the presentation. There's also potential outside the two areas that we are currently most active within, both in earlier phases of breast cancer, but also in other indications outside of breast cancer, where we have data supporting the value, and it's the same diagnostic challenge that we can address in breast cancer. It's we see that outside of breast cancer area as well.
And in that setting, the immune checkpoint inhibitor area is a very interesting area as well, where we can add value, and also we have a patent process pending, which Henrik will talk a little bit more about. If I were to summarize the highlights from the quarter, I'd like to start with the sales in U.S. We've seen a trend now over several quarters. We started on really low levels, of course, but now we're building up 50% increase since last quarters, and that's despite reducing the organization in U.S. So the team has been yeah done an outstanding job increasing volumes on our existing accounts, but also attracting new both institutions and prescribers. So the business is developing well in on the U.S market.
When it comes to our collaborations with
P harma, we see the same positive underlying trend that we've been seeing for years now. We've been building up a portfolio of both pharma companies and using in several clinical trials and projects, and there's a high demand, and we see growth in both number of pharma companies and projects being started, so that's very positive. One step back was two projects that was expected to start during Q1, that was pushed forward to Q2, and also thereby pushing the revenues forward one quarter, so we will see those in Q2 instead, which, of course, is good.
And if you look at the financials, we announced in April, earlier this year, that we'd do a reorganization with the purpose of reducing or improving our cash flow, and now we see the results here in the first quarter, an improvement by SEK 8 million versus the same period previous fiscal year. And in addition to that, we performed a direct issue where we had a European family office, as well as a couple of Swedish investors that took part, adding SEK 16.4 million initially, and there's an option to add another SEK 7.5 million in April next year, so further strengthening our financial position. And if we move into the significant events for the quarter, we continued to DiviTum to continue to prove itself in clinical trials.
This time it was a Spanish group, GEICAM, that presented the results on the CDK4/6 inhibitor on ASCO, ASCO being the world's largest cancer conference, so big impact. That's important. The GEICAM group is a leading group in Spain, also setting the guidelines and has big impact, so that helps us in that go-to-market work that we have that and with our partner, Palex, that is in the process of introducing the test to the Spanish market. Also, another so-called master service agreement for a US company developing a new CDK inhibitor we signed, and Henrik will update you about where we stand with the entire portfolio there.
And then, of course, we had our general meeting, extra general meeting to implement a new incentive program, a long-term incentive program, which is very positive to see also that the board of directors and the employees in Sweden and Denmark has participated, so it's oversubscribed, so very grateful for that commitment. And direct issue I already talked about. That was my introduction. Anders will go now a little bit more into details and provide some numbers on the quarter that we just are reporting. Anders, let's switch place.
Thank you, Anders. Yes, moving into the Q1 net sales numbers. On the right-hand side, you have the Q1 sales this year. We ended up on SEK 1.7 million, which is in line with what we had Q1 previous year. However, it's important to understand what's going on below the surface here. It's not just SEK 1.7 million compared to SEK 1.7 million. As Anders said, the U.S. sales has really developed well. We see a tiny bit of lilac color there, SEK 13,000 previous year. We have SEK 627,000 this year, so it's a huge improvement year over year. As Anders also said, the pharma service business, which are the two other revenue or product lines that we are selling currently, is also developing very well in terms of interest of the product and our services.
However, the nature of clinical trials and pharma development is always interesting, and there are quite frequently happening that these are delayed rather than pushed forward. The important thing to remember here is that we haven't seen any cancellations of work orders or master service agreements. On the other hand, we have actually signed more master service agreements and more work orders during the quarter. Zooming in on the US sales, this is in dollars because I wanted to compare without any currency impact. So close to $60,000 in Q1. We had close to $40,000 previous quarter in quarter four previous year, so that's 48%, close to 50% growth. So that's growing in line with our expectations for the quarter. However, we are expecting a significant growth continuing going forward.
Quickly then on cash position, we ended the quarter with 65 million SEK in cash and cash equivalents, and the last financial slide, as Anders said, improving cash flow significantly with 8 million SEK. This slide, I have adjusted the change in working capital, so comparing like for like, because we had this reorganization in Q4, so we did quite a lot of payments on that accrued expenses in Q4 now in Q1, so the numbers that you have in the Q1 report look slightly different, but at the end of the day, it's eight million improvement year over year on this one, so with that, I'll leave it over to Hector. See if we can get Hector in the-
I am here, but I'm-
Exactly. Waiting for you.
I think, Helle, you have to change to me, right? Thank you. Thank you. Good morning, good afternoon, depending where you are. I'm Hector Tamburrini, the head of U.S. operations, based in San Diego, California. I'm going to share an overview of the first quarter of the fiscal year from the U.S. perspective, right now. As you heard, sales performance, if you can go to the first slide, the second. I mean, this is the agenda. We're gonna review sales performance and few other topics. Sales performance, as you saw before, we had a 48% growth in U.S. dollars, but that comes associated with a 20% growth in ordering institutions over the previous quarter, which is very significant and encouraging.
That also is accompanied by an increase in the of 32% of new prescribers for DiviTum. This is extremely encouraging. We're seeing the confidence and the trust that professionals put in our test. So this is a really exciting time for the growth in the US. If we go to the next slide, one thing that we launched in this past quarter is a new initiative from the you know efforts that we put into spreading the knowledge of the test, which is organizing advisory boards.
So, we create sessions where one of the DiviTum's early adopters, and probably one of the most respected key opinion leaders we have, shares their experience in terms of using DiviTum as a treatment monitoring tool, as well as a prognosis indicator. This is based on real-world cases on how thymidine kinase activity is a sensitive biomarker to monitor the patient's response to treatment and how it was used in these real cases to make decisions to improve patient response, in some cases, to reduce side effects of the medication, and that is a very powerful message about the DiviTum capabilities. So one of the things that we enjoyed and observed was the active engagement of the attendees to these ad boards.
We also obtained valuable feedback about, you know, the breast cancer treatment from the patient's perspective, as well as the physician's perspective, which also allows us to craft and improve our messaging about DiviTum. The advantage of this sharing of experiences among oncologists is that resulted in additional prescribers interested in the test, and we are already working with several that attended the ad boards are now our active prescribers. If you could go to the next one. Thank you. So going forward, one of the initiatives that we are working on to accelerate growth is to grow the current accounts.
Once we establish the relationship with an institution, adding more prescribers from the same institution is a fairly critical process for us because we already have that account working with us, and there are many logistical aspects that are already in place. Also, adding new accounts with a very laser focus on integrated delivery networks, the big institutions that have not only the physicians, but also they cover the patient's medication, diagnostics, et cetera. So they are integrated, and they have a vested interest in optimizing the use of that medication, and DiviTum is a critical tool for them. In all these cases, one thing that we learn and we're working actively to do is to reduce the administrative burden of ordering DiviTum.
In some cases, it's simply working on the paperwork or the documentation needed. The ultimate goal is to link the Biovica laboratory information system, which is our computerized system within the laboratory, with the institution's electronic medical records. So that's an easy process for the people ordering the test and the information being transferred to our lab. I think we have one more slide, basically, showing something that I previously mentioned in our previous meeting. The ongoing clinical trials, we have several trials that we're working, as Anders Rylander mentioned, with Yale University, Washington University in St. Louis, Missouri, the Mayo Clinic, and also the Hunterdon Center in New Jersey. All of them have clinical trials that will confirm the clinical utility of DiviTum and potentially help us expand indications.
One more slide, where I want to share some of the work that we have right now in the near term. In December, there is one of the largest breast cancer symposia. It is called the San Antonio Breast Cancer Symposium, and there are six, at least six, abstracts that will be presented, including DiviTum and thymidine kinase activity test as a tool in the management of patients' treatment and progression. That will provide an excellent forum to make the test well-known and well-recognized by professionals. We plan to have an in-person ad board or discussion panel with multiple attendees to the symposium, where we can also discuss the abstracts that are going to be presented, and also have the possibility to engage new potential prescribers.
And out of the outcome of these abstracts, we expect that there might be the beginning of expansion into earlier phases of breast cancer. The other activity for 2025 that we are working on is the inclusion in the NCCN guidelines, the National Comprehensive Cancer Network for breast cancer. That's a very strong reference that physicians use and insurers use when a test is ordered or to order the test. There is an extensive process we plan to apply for inclusion in 2025, and hopefully we think that all the clinical evidence, clinical trials, and real-world experiences that we collected to now will make us possible to qualify for this inclusion. That's a very strong support that would provide DiviTum an entry point into the prescription of the test.
I think that's my presentation. Thank you for your attention to it, and I'll pass it on to Henrik right now. Thank you. Go ahead, Henrik.
Thank you very much. So I'll provide you an update on what has happened, you know, during Q1 for the our pharma service business. I'll start by saying that, you know, we continue in this part of our business to execute according to our strategy and according to our plan. And this is really about onboarding more pharma companies, and we do that by offering TK service testing as well as kit sales. And during Q1, we onboarded one new master service collaborator, but we certainly also had several discussions with more companies, and I'll come back to that on the next slide. Apart from onboarding pharma partners, we also continue executing our work orders, and we add more work orders.
This together is, of course, what is driving our work order book. As you can see from this slide here, by end of Q1, we had a work order book value, which was SEK 12.8 million, and that's approximately 10%-11% increase from last quarter, even if, you know, we continue executing on the work order book. So very positive. When we have, you know, onboarded these pharma partners, what happens then is really that for several of these, and after having executed on two, three work orders for specific partners, we start having discussions on a closer collaboration. And currently, you know, the status there is that we have ongoing discussions with three pharmaceutical companies on a closer collaboration. All these companies are all within the drug field of CDK Next Generation.
And we also have a pilot study still running, still evaluating results, and still discussing the next steps within that pilot study. So if we dive deeper into the highlights of Q1, I mentioned that we have signed one MSA, and it was PR back in late June. But we also had two new MSA discussions in negotiations during the quarter, and one is actually expected to be signed in the very near future. Both of those MSAs are with pharmaceutical companies, again, working within the CDK next generation field. One is from U.S., and one is from Europe. At the same time as we negotiate the master service agreements, we also discuss, you know, the initial work orders with these companies.
And with the US company, we are actually speaking a very significant work order here. Then apart from those new MSA negotiations, we also amended an existing MSA with one of our pharmaceutical companies, and we amended that for another two and a half years. Then very exciting, we signed an NDA with a Tier 1 US company, and we also initiated discussions with another Tier 1 US company. So in those cases, it's companies that want to add the TKa biomarker to their drug program portfolio. And that is, of course, increasing the likelihood of being successful with a closer collaboration with these companies and ending up having companion assays together with Tier 1 companies.
Also during Q1, and mentioned by both Anderses, is that we had some postponement of activities. I just want to, you know, give a bit more details here, because it's not like that we didn't receive the samples. We actually did receive all the samples, but we were not able to, because of the high number, we were not able to execute and also because of, you know, the time of the Q1 that we received the samples, we were not able to complete the whole process and feedback to our customers before we were closing Q1. Yeah, we did not, you know, completely reach what we had planned for in Q1, but we now see the highest month in ever, actually, in August.
So you will see that, and I think, you know, the August month is up approximately 300%, you know, compared to an average month when it comes to TKA service testing. So again, yeah, emphasizing nothing about cancellation. It's just, you know, I guess, a slight delay in the clinical trials at the pharma side. And then lastly, a highlight also from the Q1 is that with the immune checkpoint inhibitor patent that we have been pursuing, we're now moving into the national phase with that patent application and into those regions that we have selected as being important for our future. So by that, over to you, Anders. Yeah.
Thank you, Henrik. All right, to sum it up, so as I said initially, we have a product that measures what's really essential in cancer. We believe that it has a very, very strong potential, and the belief is even stronger now when we've seen it in action in the clinic. We've seen now it's been used for about a year in the clinic in US, and we see that it provides value to the practicing physicians, that they can act changing dosing, changing therapy schedules, improving the treatment outcome for the patient is our ambition, the vision, and we're definitely seeing that we are on the right track there. The Q1 progress that we've been talking about, we see sales development in US.
We see it in pharma service as well, not in revenues, but on other KPIs. We've improved the cash flow, and we've strengthened our financial position with a direct issue. Long term, we have still our goal to become cash flow positive on the second half of 2025. In order to do that, we need to increase our revenues significant, 35 million SEK per quarter, versus the 1.7 that we have this quarter. So there's, of course, a huge challenge, but at the same time, we also have laid a good foundation. We have organic growth in both the U.S. and the pharma service, actually in Europe also, but it's a little bit later than the first two areas.
And we're confident that we can continue that, but on top of that, we need to add agreements that can accelerate the growth further with significant steps. And we are in discussions both within U.S. and Pharma, which we have the ambition to close in the near future in order to further accelerate and reach that goal of becoming cash flow positive. And by doing so, I'm certain that we can create significant value for, first and foremost, for the patients being treated for their cancer, but also to all investors and shareholders that has invested in Biovica.
So with that, I'd like to open up for questions, and let's do it this way, that we start with Johan Unnéus, and then go to Pareto, and then Kempen.
Great, uh-
Really.
Thank you for taking our questions. We can start off with the clinical IVD sales. What about the progress in the pipeline and the visibility ahead? Of course, you have already delivered very healthy growth, but still from rather modest absolute levels.
Yeah, that's true. Could you elaborate a little bit, Johan, on the question? The... What do you want me to elaborate on?
Yes, the visibility and the pipeline of additional clinics and-
Yeah
... patients-
Yeah
... and also the prospect of taking a larger, substantial-
Yeah
... leap forward.
Yes. All right, so maybe I can start, and maybe you can follow on, Hector, if I miss something, but so yeah, we've laid a good foundation, you could say. We have now almost 30 institutions that are ordering our test on a regular basis, and but however, there's a great potential of increasing the number of prescribers per institution. There's only one or two basically on average on every institution that is ordering tests. So we have reached out to the earlier adopters that are interested in the new technology, and together with them, they have been using this, and we see some excellent patient cases that we are elaborating, presenting in advisory boards, et cetera.
And we can also see that the test is working very well in the clinic, which is, of course, super important. What we're doing now is we're building on this evidence, and we're reaching out to institution or oncologists and physicians, and institutions that has the ambition to implement this as a standard, so we can grow within the existing institution. And also our strategy, rather than as we previously said, we're looking for 10 client bill, we are focusing on client bill accounts where we can accelerate and implement usage for that entire institution, so thereby taking getting a more aggressive growth.
Very, very good example of that has turned out to be the IDNs, and there's an extra factor there, which Hector talked about, which is the health economics. Because the IDNs, they don't only provide the healthcare service, but also the coverage, the insurance for the patients. So they have an extra interest in the health economics. And then there's obvious demand for a product like ours that can make some decisions, not only for the patient but also financial health economics. So that's the strategy, to be a little bit more targeted on those accounts where we can identify people that, with the evidence that we created, that we can create a more aggressive growth. I hope I answered your question, Johan. Was that what you were looking for?
Yeah, more or less. Perhaps, is it possible to give a flavor for the pipeline of, sort of reasonably near-term IDN contracts? No.
You, maybe Hector, if you could just describe, like, the type of IDNs that we've been interacting with, without giving away the names, of course, because it's still confidential. But the characteristics, we could, I guess, disclose.
Yes. So, Johan, I hope I can address your question. So, there are several organizations in the U.S. that function as integrated service delivery to the patient. So they almost provide an insurance, so the patient subscribes to their insurance service, and that allows them to access to the service by the physicians and all related services. They also have pharmacies, so they provide the drug supply to the patient. They also provide all the diagnostics tools that they need, imaging, blood testing, et cetera, or laboratory services.
So for them, having tools that allow to make the most efficient use of how they allocate those resources could be an extremely good tool, and this is what we are trying to educate them, educate the physician, on how to use DiviTum. We know, for instance, that in many cases, a patient treated with a certain CDK4/6 inhibitor will develop side effects, and those side effects are extremely uncomfortable. Many patients go to the doctor and say, "Please, put me on something else because I can't tolerate this drug." The use of DiviTum could allow, in some cases, hopefully in many, but no, not always, the physician to follow a reduction in dose and use still an effective medication without the side effects.
This is where we can integrate the services that these networks can provide, because they're interested in keeping the patient in an effective medication, but not wasting money or dropping treatments that are not effective. That's where we see a lot of potential for DiviTum. We're using some institutions, some of these integrated networks as case studies, because we're learning, and they're learning from us, but we expect to expand down the line to others that exist in different areas of U.S. They are regional. In some cases, you have some on the West Coast, you have some on the some of the states on the eastern East Coast that are extremely significant.
Thank you, Hector. If I might add also, status right now is that we have some of these actually starting using the test to validate it, and has received good results. The next step for us is to close agreements and agree on usage on a wider scale.
Great, thanks. And on the pharma side, then, of course, this was a bit of a low delivery quarter in terms of our new pharma services and kits. What about prospects then? Henrik Winther alluded to that it's already clear that August is a step up.
Yeah.
What about the outlook?
I'll let Henrik in, and let him elaborate a little bit about the pharma services portfolio, where we stand, and what you can expect.
Yeah, thanks. Yeah, so as I mentioned, it was really you know few trials, and the samples from those two trials that were pushed into August, and hence, as I also said, August was really promising because it's up 300% as compared to an average month when it comes to the service testing. So service testing has really increased lately. We have kickstarted several of you know the bigger work orders now with some of the bigger partners. So it is looking very promising that way, and on top of that, having an extra master service agreement, that is actually also the one we signed back in June, is kicking off now in this month with the work order.
Two master service agreements in negotiations, one close to finalization, and also with the start in November, December, with samples. So, it's very promising on the testing piece. When it comes to the kit sales, it's a little bit more unpredictable, but it's still, you know, kind of dictated by pharma, because it's pharma using CROs and CROs buying our kits. So we have, you know, we are very happy, you know, with the progress we've had so far, and especially on the service testing piece, because that is growing significantly. Yeah.
Thank you, and finally, then, it's interesting to hear that you are in discussions then regarding potentially pharma collaboration or commercial partner regarding companion diagnostics.
Yeah
... one or two, two.
Yeah.
And-
Uh
What about the...? Sorry?
Yeah, if I could add to that, what you're saying and what Henrik said, we have already in the past reported that we have the majority of companies that are developing the new generation of CDK inhibitors. That area is expected to have revenues, depending on the analysis, of $40-50 billion about 10 years from now. So it's an extremely interesting and attractive market to be part of, and also to support pharma to be competitive on that market. Of course, if you look at... So we've added two tier two and tier three that we have signed, and now we are in discussion with the additional tier ones. And especially the tier ones, we have three since before.
Those are the ones that really increase the probability for achieving CDK or companion diagnostic collaboration deals. CDK and CDX is very similar, so that's why when Henrik says he's extremely happy with the development, that's also because we are closing in to that agreement with the partners that we are discussing with now, or the companies that we're discussing with now. Sorry for that, yeah.
Great. Thank you. And finally, then, what about the prospect of commercial partners on the clinical side?
Yes. On the clinical side, we communicated that we would look into the possibilities. I think we've received some positive feedback there as well. And I think what would really improve our attractiveness for such a deal with a big diagnostic company is to continue what we're doing, growing revenues, proving the commercial potential, and also adding data that we're complementary or even superior to ctDNA in this application monitoring, which we have since before from the BioItaLEE, but to strengthen that, and also strengthen the documentation, the data that we have potential outside of the metastatic breast cancer area. As Hector said, there's a lot of good abstracts coming up by end of year.
So, it's looking good there as well.
Great. Thank you.
Good. Thank you, Juan. If we move on to Pareto, I don't know if it's Jan or Dan or both.
Hi, everyone.
Hey.
Hi, Anders.
Good.
Good to listen to the update and good progress, considering the size you have. Just a question that came up during the call now is regarding August. You mentioned 300% on an average quarter. Looking at some numbers here, and that's somewhere between 4 million-6 million SEK, or did I look at something wrong here?
You wanna just... So, Dan wants some more direction on the services fee for August, Henrik.
Service fee?
It is on page nine in the report. There's a breakdown, Dan, of the fees.
Yes, but regarding August, and Henrik made the comment that it's 300% up on an average quarter, so-
Ah, you know what-
And this quarter wasn't an average quarter, I guess, so it's a bit-
Yeah
... a lot of
Uh
-unclear, um.
Yeah. Well, I think we need to wait until we give the next- we will wait to give exact numbers until the next quarter report. But you could say it like this. We had, if you look at our average quarter, for Q4, for instance, the majority of the revenues was from the pharma services, so it was a stronger quarter even than the Q1. So average quarter is typically stronger than this Q1, where we had delay or revenues pushed forward. Yeah, so that gives you some guidance.
So it would not be wrong to take that Q4, where it was 6.5 million SEK, divided by three for three months, you end up a bit over two, and then you add 300% on that, you end around six million SEK.
You give a very detailed here, but that sounds like a good approach. Yes.
Okay, interesting. Thank you, and congrats on that. Are there any further cost reductions expected now going forward, or can we assume that this is now a bit the constant burn that you have going forward?
You can assume that this is a constant burn, and we're able to increase our revenue with this more efficient organization, so that's our focus.
Okay, great. Thank you, and, regarding the U.S. sales, are there any indications that you see, a pickup, of sales that would, yeah, cross a few million SEK in the coming quarters?
Yes, that's definitely our ambition. So if we're gonna make that the goal in like 15 months from now, to have SEK 35 million per quarter, we need to pick up, we need to increase the growth rate versus the quarters leading up to this quarter. Just do the math, you will see that. And the way we think we'll be able to do that is that we believe we can continue and increase the organic growth component, but we will add agreements that will accelerate, with bigger, where we can, instead of grinding, taking prescriber, actually, be able to get an implementation, one big institution.
That's the ambition to drive the growth, and that's also where we are in discussion with both IDNs and some institutions that want to apply it as a standard marker for that institution.
Okay, thank you, and just getting back to the pharma sales, that seems to have also picked up now after this quarter. Do you expect that then to continue, or was this August just a very kind of outlier, or do you see that this is continuing?
A little same. It's a little bit the same mechanics there as well as within the U.S. sales. So we have an underlying organic growth. We are signing more and more both master services agreement, and that leads to more work orders, and existing customers implemented on more and more of their clinical trials, becoming more of a standard marker. So that will continue, if you call that organic growth. And the big game changer also, which we expect within the coming 15 months until that breakeven milestone, is to sign an agreement that is a co-development for a companion diagnostics product that could have the same accelerating factor, which will, yeah, lead to a bigger deal with quicker to bigger revenues.
Henrik has given guidance in previous calls and in investor meetings on exactly how we see that such a project is structured.
Okay, thank you very much. I think that is all from me. Thank you.
Thank you, Dan. Luisa?
Yes. Hi, team. Thank you for taking my questions. Maybe the first one on... You mentioned the inclusion of DiviTum in the NCCN guidelines. Could you elaborate here a bit more on what are the steps necessary, also in terms of timelines, what is the usual process?
Maybe Hector, if you want to do that, or?
Yes, yeah, I can do that, so hi, Luisa. Yeah, I, we're at the beginning of the process, but basically there is a very... First of all, there is a set time when we can apply. Each area within the guidelines has a set time or dates that they accept the application. I think we're looking at Q2 2025 for breast cancer. We have to prepare an extensive list of questions that we need to respond, gather clinical trials, clinical evidence of the test, and how it's being used, and this is a process that we are beginning right now. Hopefully gathering all this information, and we will rely probably on input from some of our key opinion leaders when we need input from them.
But it will take us a couple of months to get all organized to apply, and then send the application into the organization.
Okay, very clear, thank you. And in regards to, well, other inflection points until year-end, so until the end of this year, what can we expect in terms of inflection points? So how many more distribution agreements in Europe, pharma agreements, so that kind of events?
All right. So, for the remainder of this year, you can expect to see especially agreements on the U.S. market is what's closest, and also agreements within the pharma master services agreement in the coming months.
Okay, thank you so much. That's all from our side.
Thank you. All right, we have only one question, actually, from the web, and the question is about the increase of subscribers. Can you elaborate a little bit, Hector, in absolute numbers, number of prescribers currently using the test?
So the question is, how many prescribers-
Yeah
... are using the test currently?
Yeah, the number of. It says subscriber, but I think they mean prescribers are using-
Prescribers, yes, yes, yes. And we use that term because in some, depending on the state, not only physicians can prescribe tests. In some cases, nurse practitioners or physician assistants can prescribe, and we've seen, even though in a smaller percentage, but we've seen some of them, especially in offices that share the treatment of the patient between one or two professionals. We are right now in the range of over 30 active prescribers. Some of them are really active, have incorporated the test into their practice, and they have the majority or a big proportion of the tests that we process currently. But right now we are, I believe the number is 33.
I don't want to give you the wrong number, because that changes on a weekly basis, but that's the range where we are right now. Yeah.
All right. I think that was it for this session. Thank you all for calling in, and thank you for the excellent questions. So let's say thank you, and over and out from Biovica.