Biovica International AB (publ)

Thank you start.

Hello everyone and welcome to the earnings call for the second quarter of Bayvik has broken fiscal year for 23 and 24. So we can shift slide. Uh, the presenters for today will be first. It will be me, Anders Rulander. Followed by Warren Creswell, Henrik Winter and Anders Morend. And the agenda for the call is a short introduction from me, and then I'll talk about the highlights. Then we'll dive into a US update with Warren Creswell. And Henrik Winter will provide an update about our pharma services development. Anders Morén will provide an update about the financial status before we have a summary by me and the Q&A session. And you can all post questions using the functioning Teams. And if you want to remain anonymous, you can do that as well by checking that checkbox. And at the start of the session, we will let the equity researchers in from Redeye, Pareto and Kempen. So they also would have the opportunity to ask questions, follow up by questions that we received from other participants. So I will start by talking a few words about our product. So we are all on the same page here. So the product is called DIVITUM, stands for dividing tumor. And with DIVITUM, we can, from a simple blood test from the patient, measure cell proliferation. And in the cancer, that is essential and important information as cancer grows through uncontrolled cell proliferation. So DIVITUM can provide important information both before and during treatment, information about the aggressiveness of the disease and also provide quick response if the treatment is effective or not. We have in clinical trials shown that we can provide such information if the treatment is effective or not only two weeks into treatment. That is a significant improvement versus imaging, which is the standard method being used today. which requires three, four months before evaluation of progression is typically done. We've also in another clinical trial shown that we on average can provide feedback about progression around three months on average quicker than with imaging. So we have a very convenient tool for monitoring of cancer therapies in the metastatic setting. We've shown several clinical trials. Talking about clinical trials, here's a summary of the clinical trials that we have published so far together with our partners, or to be correct, it is the partners that has used our assay and used it in clinical trials that have made the publications. Before that, they'd be peer reviewed and published in scientific journals. This is, of course, essential for us, having data proving the value of the product. These trials are shown that the DIVITUM is strongly prognostic, both in local setting of cancer, but also in the metastatic setting where it's been shown to be prognostic both for progression and overall survival. And it's also been shown to be an excellent monitoring tool where we've been able to follow patients and take in repeated samples over time. Our focus area is the breast cancer area where we have the majority of the data, 14 studies and over 3000 patients. We also want to highlight the collaborating partners. We have really strong key opinion leaders, some of the leading ones in this area, especially within the breast cancer area that has performed these trials at some of the most well-renowned academic institutions in the world, such as Mayo Clinic and Johns Hopkins and then Dana-Farber, et cetera. This is of course important because these people and these institutions, they have impact when they reach out to others and present the results of the clinical trials. When it comes to our go-to-market plan and the market potential, we'll talk a little bit about the plan and the different areas. Our focus is initially now to commercialize the product for use as a monitoring tool within metastatic breast cancer, both on the US market, where we have an FDA clearance since last year, and we're now in the ramp up of the commercialization phase, which Warren will talk more about. In Europe, we also have a very good start where we have signed several agreements with partners that is providing analysis services and also has a sales force working against oncologists on certain European markets. Another area with great potential is the pharma services area where we serve pharma companies using our product when they develop new therapies within the cancer area. something that Henrik will dive into and explain a little bit more where we stand. We've made great progress there as well. Looking further ahead, we have also great opportunity and potential to widen the use outside of the breast cancer area into new indications. We already have data on metastatic malignant melanoma and in combination with immunotherapies, we also see potential within lung cancer and prostate cancer. So there's a great potential for the product and we have also made great progress during the last quarter where we are in early phase of our commercial journey of commercializing the product. If we dive in to the second quarter of our fiscal year and the highlights that we've had, it's been quite a few actually. It's been that many that we have now been forced to categorize them. If we start with US and clinical, Warren will cover these a little bit more in detail. But we made progress when it comes to direct bill agreements directly with US hospital or hospital networks, you might say, because we are now covering around 50 hospitals with these three agreements in three states in the US. We also made a PR about the preliminary decision with the gap fill process for CMS. And then after the end of the period, we made a new PR that in the end we concluded or CMS concluded that we'll go with a quicker method called crosswalk, which means we'll have a price or be included on the Medicare price list from start 1st of January next year, which is great news. Warren will also explain a little more what that means. We're making progress when it comes to the lab. We got the CAP accreditation that opens up opportunity in certain geographical areas and at certain also private insurers, et cetera, which Warren will talk about. And we are continuing to strengthen our clinical data by initiating new clinical trials. So a lot of progress on the US area this quarter. Looking into pharma, we have now a portfolio of projects and we can see that they are growing and we can see that revenues are keep growing. Henrik will give you some little more guidance around what we've done there and also how we've been able to, within which areas we've been able to grow our business there. And also when it comes to the more administrative PRs that we've issued, we've communicated that we will do a rights issue that's partially guaranteed and we're progressing with that. We've also carried out an EGM in that process. And then the last news before end of, or sorry, after the fiscal or after the Q2 ended during November, we announced that we signed a commercial agreement for Europe. And if I move into that slide specifically, it is with a Danish company called Axelab. A company is growing very fast and is focusing on diagnostic or sales of diagnostic products. And they have a customer facing team of 25 reps within sales and marketing. And they are planning to expand that when they're bringing in dividend to their assortment. So this aligns very well to the kind of partners that we would like to team with that is successful, fast growing within oncology, has a sales force, has the competence and the drive to make us both successful. And we've set aggressive targets to, within three years, realize 15% of the market potential on this market. And I think also we have some really strong partners when it comes to the clinical setting with Karolinska and we have ongoing trials also with Krista Hospital in Manchester that Swedish hospitals like the one in Linköping also is part of. This is great news also for the European area. All right. Then I'll let Warren on stage. And Warren, if you please, can take us through the US status and walk us through what happened during the last quarter.

Great. Thanks a lot, Anders. I really appreciate it. There you go. We continue to execute our U.S. strategy, and I think this quarter has been not only productive, but I think very exciting for the organization as well. Throughout the presentation, I'm going to talk about a number of different topics. I'm going to talk about Medicare pricing that was recently established. I'm going to talk about the three hospital contracts that Anders alluded to. I'm going to talk about regulatory progress we've made with our CLIA laboratory. I'm going to talk about clinical trials that are ongoing in the US. And then I'm going to finish with some feedback that we've received from medical oncologists that's been very positive that I wanted to share.