Biovica International AB (publ) (BIOVICB) Earnings Call Transcript & Summary

Hello, and welcome to the Biovica Annual General Meeting CEO Presentation. This year, it is virtual, as you can see, and so is the voting process. So I recommend you to go to our home page for instruction on how to vote. This presentation, I will start with a short background about the company, and I will tell you about the highlights of the fiscal year that just -- we just closed and also a little bit of the upcoming milestones that we have ahead of us. So Biovica develops and commercializes biomarker assays for measuring cell proliferation. And our vision is to contribute to more informed decisions to the benefit of both patients and health care providers. Our mission is to establish our product dividend as a standard tool for monitoring treatments within cancer. And DiviTum is the product name, it stands for dividing tumor. And it measures cell proliferation from a blood sample. And cell proliferation is essential. It's what defines cancer, uncontrolled cell proliferation. So with DiviTum, we can provide very important information for the treating physician, both about the aggressiveness of the cancer before treatment and during treatment to follow up patients and give feedback on treatment efficiency in order to make sure that the patient gets the best possible treatment and the money spent on treatments are spent in an efficient way. The strategy for us to launch the product is to find an attractive niche where we can meet a clear, unmet need and be successful in commercializing the product. The niche that we have chosen to focus on is metastatic breast cancer, where there is a need for better biomarkers in order to manage treatments, especially within endocrine and targeted treatment, which is our focus area. The way we approach this is through strong collaborations with key opinion leaders within the area and together with them, to perform clinical trials in order to document the value of the product. This is also important for other activities such as achieving regulatory approval, reimbursement, commercial agreements, but also generating demand for the product. After the initial launch within metastatic breast cancer, we plan to widen the use both within early phases of breast cancer but also outside of breast cancer. And when it comes to geographies, we're focusing on U.S. and selected countries in Europe. We also have collaborations with the pharma companies that are using our product to develop new therapies, cancer therapies. And our strategy is to expand on those collaborations and going to codevelopment projects in order to develop new products. If we look at the year that we have now behind us, our fiscal year ended in May. A few of the highlights that I would like to mention is, first of all, the FDA process, the regulatory process because the U.S. requires a 510(k) process, which is managed by the FDA. And this is something we've been working with for several years. We started with a so-called presubmission, where we based on the intended use that we've defined, which is metastatic breast cancer. Have discussed with the FDA and defined what predicate device, what type of analytical validation is required, what type of clinical validation is required. It all comes down to the selected intended use. Since then, we have performed these analytical and clinical validation trial and the data has been put into an application that we submitted in September last year. Shortly after that, we got the feedback that this -- FDA started a substantive review. But just after start of review, we ask got, as everyone else, that all non-COVID applications was put on hold due to the pandemic situation. We were lucky to get a restart in the beginning of -- or by end of January this year, but nothing really happened until end of May when the process restarted with the feedback from the FDA, which we have been working with them and discussed since then. So it has been a really intense summer where we have had several meetings, including a so-called SIR meeting when the -- where the FDA has gathered their expert within different areas. So we've been able to have really good feedback on all the open questions, and we're confident that we can address them all in our response. And the response we are planning to submit in beginning of September. And by end of September, we expect to get feedback from the FDA, given that they can keep with their normal time lines and either a clearance or that we need to complement with additional info. But we believe we have a good opportunity to get the clearance. Another area I'd like to highlight is the results from different clinical collaboration, clinical trials. And last year at the San Antonio Breast Cancer Conference, which is the biggest one in the breast cancer field, we presented 4 results from different clinical trials within our focus area, metastatic breast cancer. That was something that really strengthened our value proposition within this selected intended use. We also presented data together with Karolinska about the locally advanced breast cancer, so slightly earlier than metastatic breast cancer. And that's also important since that's an area we would like to expand into. In May, we were present at the ISPOR Conference, the health economy conference, which is also important because we would like to prove the value of the product to the payers. And the conclusion from that presentation was that every -- for every dollar spent on DiviTum, the payers would give $3 in return. This was an important starting point for the discussions with the payers that we now have started in the U.S. And lastly, I'd like to mention the ASCO Conference, where we presented the data -- or the Karolinska presented data based on a -- from a trial that they have done with DiviTum within metastatic malignant melanoma. And these patients were also treated with immunotherapies. So that's an interesting area that we would like to expand into. Hence, those data was also important for us. And talking about different areas and the potential we have since before communicated that the metastatic breast cancer area, we estimate to about USD 600 per year and adding locally advanced breast cancer, which is about 1/3 of the potential, so another USD 200 million per year. We presented the plan for expanding outside of the breast cancer area based on areas where we identified an unmet clinical need that we can meet and areas with great potential. A metastatic malignant melanoma was one, lung cancer was another and metastatic [ prostate ] cancer was the third. And these 3 new areas combined adds -- more than doubles the potential for the product. And as I told you, we are already active in doing clinical trials in several of these areas. In order to bring the product to the market, we, of course, also need a strong organization. And within this year, we have strengthened the management team in 3 key positions. One is the regulatory area, where Joakim Arwidson has joined. Another one is the commercial area, where Helle Fisker has joined, and she's responsible for the European markets. And Warren Cresswell, responsible for Americas, joined here in August. These 3, together with the already strong team that we have since before, adds a lot of experience within this field and taking products to the market within oncology and diagnostics. So that fits really, really good. If we look forward, we have some interesting upcoming milestones, which touched upon the 510(k) clearance. We expected to get that during third quarter. So -- and that's the starting point for our commercial activities in U.S. After 510(k) clearance, you're allowed to market the product on the U.S. market. And looking at Europe, we have the same milestones, CE marking and launch in the first country before end of year. We have to sum it up. We had a very exciting and successful fiscal year that we now have behind us, and we're well into the next -- the current year. And it looks to be even more exciting with the upcoming milestones. So I thank you very much for listening to us. Thank you.