Biovica International AB (publ)

Hello, everyone, and welcome to the Biolika Q1 earnings call for the fiscal year 23-24. My name is Anders Rylander, and I will, together with some of my colleagues, the one on the screen here, Warren Crestfall, responsible for our US business, Henrik for our pharma business, and Anders, our CFO, For us, we'll go through the reports and the highlights, and this is the agenda. So I'll give a short introduction about the company in general. Then I'll go through the highlights for the quarter. Then Warren will take us through the U.S. status, where we stand, and Henrik will do the same for our pharma services and collaboration. And then lastly, Anders will do a financial update before we go into summary and Q&A. In talking about Q&A, you will have the opportunity to ask questions using the chat function. And if you, for some reason, want to remain anonymous, you can do so by checking that checkbox. And we will start the session with our equity researchers that will be let into the call to ask questions about the report. So if we start with the company, the company by Vika, BioVirus Cancer is what it stands for. It was founded in 2009. However, it's based on research that spans many decades back. So it's from Uppsala University, where the headquarters still is based. We're currently publicly traded at Nasdaq First North Premier. since an IPO in 2017. And in recent years, we have established ourselves and built up a business in the US with a headquarters in San Diego, where we also have our CLIA-certified lab, where we'll talk a little bit more about our business model over there. When it comes to regulatory status, yeah, we have been ISO-certified for many years, and we both have regulatory approval both in the US, on the US market, with our 510 cake. clearance that we received last year. And we also have a CE label which allows us to use the product or market the product for clinical use on the European market. So those are our two focus markets. And our vision is to improve cancer care for cancer patients by offering innovative blood-based biomarkers. And talking about our innovative and blood-based biomarker, Our product DIVITUM stands for dividing tumor. It's our first product, which we are now launching on these markets and using in our pharma collaboration. DIVITUM stands for dividing tumor. And so what we do is through a blood sample, we're able to measure cell proliferation. And as you all know, cell proliferation is what is defining cancer, at least uncontrolled cell proliferation. So by using DIVITUM, the treating physician can get very important information about the disease state. And we also shown in several clinical trials that we have the ability of providing quick feedback on treatment efficiency for patients being on treatment for their cancer. And this is also our first and key application. We have also focused on the metastatic breast cancer area where there's an unmet need created by new targeted treatment within that space called CDK4-6 inhibitors. uh creating a lot of improvement for patients on treatment but also some challenges and need for better biomarkers and need that we can meet we've shown in several clinical trials and that's also the basis for our 510k clearance from the fda and this of course is important for the patient making sure that you are on an effective treatment and if not you can switch to a different treatment because there are many treatment options but also for uh for the healthcare providers as these treatments are very costly with a standard price over ten thousand dollars per patient a month so there's many winners from using dividend uh you can create great values And talking about our commercial roadmap, as I said, the breast cancer, and specifically the metastatic breast cancer area, is our focus area. Hence, we have taken ourselves to the regulatory pool, allowing us to launch a product on the US and the European market. In US, we are going to market using our own CLIA lab and our own sales force. uh and in europe we are uh working through partners uh in um yeah and uh uh we're in three years after launch our ambition is to realize 15 of that market potential and long term we expect to be able to realize 50 on the market that we launch a product in within Currently in Europe, we have launched the product on our three first territories and looking to expand to further territories. Beyond the metastatic breast cancer area, we also expand the product within earlier phases of breast cancer. And we also have proof of concept data, early data outside of the breast cancer area. One very interesting area is the metastatic malignant melanoma, where patients are being treated by checkpoint inhibitors. where we together with Karolinska have strong results, which we are looking to build upon. And on this slide, the third area is our pharma collaborations, where we have the ambition together with pharma to co-develop new products financed by pharma and creating value both for the pharma company, developing a companion diagnostic product, as well as for the patient, of course, making sure that you respond to that treatment. This is Henrik's area and he will talk more where we stand within that area. That was a very short introduction and summary of the company and where we stand. And if you look at the first quarter in our fiscal year that starts 1st of May and ends in July, this is what we reported as significant events. During that time we had, if I group them together, we were able to launch the product and enter our first three commercial agreement on the US market with private payers. This is significant for us being able to establish the product in that private payer community and something that Warren will elaborate a little bit more about what that means. Talking about the US market and the payers, we have a different area. That's the public part of the market, and that's covered by Medicare. And the first milestone to get into that system is to get a PLA code. And that is something that we reported that we were able to do in July this year. Also a big milestone, which Warren will talk a little bit about more. And we have already a really, really strong foundation when it comes to the clinical evidence, and that was further strengthened by the publication of the so-called SWOG trial. The SWOG trial was the one that we used in our FDA process for our clinical validation, so we have talked about that in the past. What was interesting with this presentation that took place at ASCO was that we in this presentation presented results where we were compared towards CA-15-3, which is an existing biomarker that is being used within the breast cancer area for breast cancer patients. And Divitam came out very strong. This is the second time we've been compared in publications or clinical trials, and it's the same result that Divitam performed very well. That was the most important milestones that took place during the quarter and after the quarter ended in July, we announced that we started yet another trial. This is a prospective interventional trial together with Yale. And Warren will cover that as well in his presentation. So to sum it up, we're super happy that we are making progress and we also are meeting the milestones that we set out before the start of the quarter. And so we have received a really good start on, especially the US market where we just entered commercially and looking at the pharma business is still progressing well, which I'll cover later on. I think that will do as an introduction from my side and I will now leave it handed over to Warren to go through the US business. So Warren please take us through the US business.

Thank you so much Anders and so what I'm going to be talking about is the real continued how we continue to execute the US commercial strategy and the progress that we're making and I'll be covering. Really, the early engagement and the very positive feedback we've received from medical oncologists on Divitam. I'll be talking about the benefits and progression that we're making with respect to our client bill contracting. And this is really specific to hospitals. I'll talk about the expansion to our commercial agreements. We've expanded by one this quarter. I'll also be giving a status update on establishing coding pricing and reimbursement. This can be a very complicated area of our business. And also, I will be talking about the very positive strides that we're making from the clinical side by both strengthening and expanding our clinical utility in breast cancer. Next slide, please. So as I've mentioned previously, we've constructed a very sophisticated call plan strategy. And part of that strategy is calling on patients NCI and NCCN designated cancer centers and also very notable cancer centers also calling on key opinion leaders and regional thought leaders and also community oncologists that have a high portion or high number of metastatic breast cancer patients that they manage. So we've really focused on that. I'm really proud to report that we've had 100% engagement and ongoing engagement with NCI and NCC and designated centers. There's very high interest in Divitam. And in our targeted number of medical oncologists, that number is about 1500. So far to date, we've done 525 clinical presentations and we have ongoing dialogue with these individuals. So the feedback from Divitam has been very, very positive. And in fact, I've put some comments down there below in regards to kind of some key things that we keep hearing over and over and over. And one of which is Divitam addresses a biomarker white space that is desperately needed to manage Medicare breast cancer patients. And there's just a real lack of blood-based biomarkers that can help physicians manage those patients. And that was something that's a real call out The second one is identifying non-responding patients that enables clinicians to switch therapies that are clinically needed. So today, physicians are looking really for signs and symptoms. They're looking for imaging results before they would switch a patient. And here they can use Divitam to really help provide additional needed information to make those decisions on how to manage those patients. And the third thing that we keep hearing over and over and over is around imaging and physicians will likely lengthen time between imaging for patients with low TKA values. And, you know, many of these patients are very ill and going and getting imaging can be a burden to these patients and physicians really want to manage imaging the right way here. So Divitam really provides some additional information so that potentially clinicians can lengthen the time between imaging and also flip it around where they may need to shorten the time between imaging as well. So it's really been positive feedback we've received from medical oncologists. Next slide, please. So we're really focused on executing client bill contracts. And again, these are hospital contracts. And the rationale is it really does drive accelerated growth in our business. And by being able to contract with an institution, and the one point I want to make is Contracting with an institution isn't one institution. Some of these institutions that we're dealing with have 15 separate hospitals. So they're really healthcare systems that we're contracting with. So when we contract with an institution, we're really contracting with a family of those hospitals that are part of that institution. So these agreements that we're putting in place are significantly important to our business. What it does as well as when we speak to a medical oncologist And we have that discussion about bringing that test on board with that institution. Typically, there's a follow-on meeting with something called the formulary committee that really makes the decision for the institution overall in regards to does this product have clinical utility? Can our medical oncologist use this to help manage the patients? And this, the discussions that we had have been very, very positive. And we do have a number of these agreements in the pipeline. The first one we believe will be signed in Q2. So what does it do for us? It drives access within the institution. It helps out with respect to the ordering process within the institution. And the third thing is, is it does guarantee payment to BioVica. So instead of us being able to bill insurance companies in these situations, we actually invoice the institution and we receive payment from them. So this is really a strategic imperative of our business moving forward. And our Goal for the full year is 10 contracts, which I believe we'll be able to achieve. Next slide, please. So we're proud to announce that we did sign the third commercial agreement. This was with Oakham Health. And just as a reminder, these agreements are really considered kind of rat PPO agreements. And how they work is they really provide solutions for organizations that are self-insured where the product is not yet contracted with an insurance company. And this is what happens when you newly launch a product. You're not contracted with all the big insurance companies out there. So what you can do is you can contract with MedIncrease, Contigo Health, Oakham Health, and that actually provides the avenue for that patient to be able to get the test and it provides an avenue for the organization like BioVica to be able to get compensated for that test. So what we do is we negotiate with these organizations, we negotiate a rate with these organizations. So that really provides not only easy access for the patient to get the product, but it also provides payments in BioVica while we work with these private insurers to be able to be covered moving forward.

Next slide, please.