Biovica International AB (publ)

Hello everyone and welcome to the Byvika Q1 Interim Report. Today it will be me Anders Rylander together with my CFO Anders Morén and Hector Tamburini, Head of US Operations and Henrik Winter, 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 Paretta 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. Divitam has shown to be an excellent tool, both before start of treatment to provide a prognosis of how the aggressive 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 to follow up 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 you 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. this what i'm saying is has been proved in in many clinical trials over 30 at this point has been published uh 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 uh these clinical trials has been performed by some of the leading institutions and oncologists in the world in the us we have uh Mayo Clinic, Dana-Farber, Washington University and Johns Hopkins, for instance, Baylor College, those are all examples of institutions and oncologists that we have been working with to perform these clinical trials. And then 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 colleges 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. uh, where we are currently, uh, uh, focused in our commercial efforts in us and in, uh, the major countries in Europe, including the Nordics is our focus area. We are also active, uh, supporting pharma. Pharma can benefit from using our, uh, productivity 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. And 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 Winter in the presentation. But 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. You see that outside of breast cancer area as well. And in that setting, the immuno 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 US. 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 quarter, and that's despite reducing the organization in US. So the team has done an outstanding job increasing volumes on our existing accounts, but also attracting new, both institutions and prescribers. So the business is developing well on the US market. When it comes to our collaborations with pharma, 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 is a high demand and we see growth in both number of pharma companies and projects being started. So that's very positive. One setback 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 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 eight million Swedish 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 16.4 million Swedish initially. And there's an option to add another seven and a half in April next year. So further strengthening our financial position. And if we move into the significant events for the quarter, we continue to, DIVITUM to continue to prove itself in clinical trials. At this time, it was a Spanish group, GACAM, 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 GACAM 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, Pelex, 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 recording.

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 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 1.7 million compared to 1.7 million. As Andrew said, the US sales has really developed well. We see a tiny bit of lilac color there, 13,000 previous year. We have 627,000 this year, so it's a huge improvement year over year. As Andrew also said, the pharma service business, which are the two other revenue or product lines that we are selling currently, 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. important thing to remember here is that we haven't seen any cancellations or 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 and quarter four previous year. So that's a 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 in cash and cash equivalents. And the last financial slide, as Anders said, improving cash flow significantly with 8 million Swedish kronor. 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 8 million improvement year over year. uh, on, on this one. So with that, I'll leave it over to, uh, Hector.