speaker
Anders Weilander
CEO

Hello everyone and welcome to the Bioweek Q4 and the year end report. And here's our forward looking statement disclaimer. The presenter for the webcast today will be me, Anders Weilander, the CEO, followed by Anders Morin, our CFO. Then Hector Tamburini, head of US operations, will present the US development and also Henrik Vinter responsible for our pharma businesses area. And the agenda we will go through is our standard agenda. We'll start with a short introduction for people that are not so aware with our business. Then we'll move into the fourth quarter and the highlights and Anders will follow and give a financial update. Then Hector will do the US update. Henrik will do pharma services update. And then I will summarize and we'll move into the Q&A session. And for the Q&A session, we will have our three equity researchers, analysts from Pareto, from Kempen, and from Redeye that we will let in. to the meeting to ask questions directly. But all of you that are listening into this webcast have the opportunity to post questions that we will do after the analyst session. And we'll ask as many as we can until we break at 4 o'clock the latest. If you want to post anonymous, you can do that. But then you have to check that checkbox. So if you're worried about our company BioVica and our product Divitum. So Divitum stands for dividing tumor. We measure cell proliferation by measuring a very important enzyme active in the cell proliferation process, which is called thymidine kinase. So it's very much so the core of cancer as cancer grows through uncontrolled cell proliferation. This has proven to be a very effective method, both to be used prognostically before a start of treatment, for example, but also an excellent way of monitoring patients being on cancer treatments as a change in cell proliferation indicates whether the patient responds or not to the treatment or if the treatment is effective, I should say. test is blood-based which allows for simple and quick analysis and we've also shown that we can provide information month ahead of the standard method being used today which is imaging this conclusion and and the documentation lies on a very strong foundation and solid ground with over four 30 peer reviewed unpublished scientific articles. The majority of the documentation is within the breast cancer area with about half of those publications and over 3000 patients. And it's done in combination with and by world leading academic institutions and key opinion leaders, which of course is very important for us to communicate the message in a trustworthy way, which also reaches out to other oncologists. In US, we have several well-renowned collaboration partners of which we have published with the majority of these. We have the Mayo Clinic, we have WashU, Washington University, Johns Hopkins, Baylor College, etc. In Europe, we have both Karolinska, the Institut Curie, etc. and the Prato Hospital in Italy that has done several collaborations and publications. We also have a breast cancer group in Europe with IBCSG, a big international group covering several companies in Europe and also with a small group in the US. We get an excellent reach for the data that we have been publishing. If you look at the market potential. We've focused initially at the breast cancer area and within breast cancer monitoring of metastatic breast cancer. The two markets that we are focusing on is the US market where we go to market with a CLI model where we offer the test as a service and in Europe we have focused on the bigger countries and the Nordics Our focus on the go-to-market model is through partners that we sell kits and they provide the go-to-market service, including setting up labs, taking us through reimbursement, etc. We focus on partners that have a sales force with oncology that can meet the customer and generate demand. The market potential is based on, in US, an average price of $400 times the number of patients being on treatment for this disease. And as Hector also will see, this assumption seems to hold very well now when we also are on the market. We have Great potential outside of the metastatic brain cancer area to expand and become a standard method of evaluating treatments within cancer, especially within the targeted treatments area where you target the cell proliferation cycle. And one example of that are the collaborations we're doing with pharma. to support them to develop new therapies and also have the opportunity to co-develop new products complementary to new therapies. This generates value both for the pharma companies as well for patients and for the healthcare providers. Henrik will talk about this process in his part of the presentations. And looking further down the horizon, we have other indications that we have identified, and we also have started to generate data. One good example is the metastatic malignant melanoma, where we have data published and also an IP process going, which we'll report and give an update on. And then also interesting areas are prostate cancer and non-small cell lung cancer. If we go into the fourth quarter that ended end of April, so February to April for us, as we have a broken fiscal year. I want to highlight some areas, all our three major areas, US, private services and Europe. I think we made great progress. we did not reach our 10 million sales goals in total, which we're of course disappointed with. But despite that, we see a great progress in all these three areas. And if we start with the US area, we see that the trend that we reported in the third quarter, we are really getting momentum and we see that the revenues grows and we get new oncologists ordering from new institutions and the number of patients are growing. So here we see a really, really strong trend, which we think is very, very encouraging. And this is something also Hector will dive into a little bit more. Same thing with pharma services. Here we've seen the trend for some time. And if you look at the year-on-year and the Q4 revenues, we also are developing that very well in a good direction. And also we have some awesome that Henrik will elaborate a little bit on. And also in Europe, we have two strong partners, which we have a great belief in. Palix in Spain got a good start as we were presenting data with the GACAM group at ASCO. GACAM is the Spanish breast cancer group. That is the one that is defining guidelines, et cetera. Important key opinion leaders to work with in order to introduce the test on the Spanish market. In the Nordics, we have an agreement with Axelab, and we also see that they are moving forward. They go to market work, and they have hired two sales reps that soon will be starting, and they are dedicated on working with Divitum. So progress in Europe as well. If we go into the actual highlights that we have communicated during this fourth quarter, The first three one on this page is related to our pharma services, the two master services agreements that we signed and also that resulted in work orders related to those master service agreements. So this is an evidence of the progress we're making within the pharma services. Another thing within this or related to this area is the patent process that we have to expand our patent specifically for immunotherapies. And this opens up a new area for collaborations with pharma that has a very large potential, even larger than the CDK4-6 inhibitors that is our current focus. If you look into the US area, in addition to the positive development when it comes to the revenues and the number of oncologists and institutions and patients, et cetera, we also are seeing a greater interest from oncologists to study this further and include patients in both interventional and observational trials. This has great value for us. The intervention trials will help us to drive demand and the observation trial is more local trial. The Mayo Clinic also creates awareness and also as this being standard of care treated patients, it contributes to our revenues. We did announce. cost saving and restructuring program at the end of the quarter, which will give savings of 30 millions per year or 25% of our costs. And I'll go into that on the next slide. Finally, after the end of Q4, We communicated that we are together with GACAM, did present the result at ASCO. We've been active at both ASCO and AICR and both at these two large conferences, ASCO being the largest one within oncology. We've received, it's been very successful in terms of creating awareness and also establishing new relationships with pharma companies that has led also to progress when it comes to sales and agreements, which Henrik will dive into a little bit more. Yeah, the cost reduction program, I'll give you some background around that as well. The implementation of that led to a reduction of 10 employees, five in the US and five in Sweden, and rationale for doing that was to lower the cost levels and to address some performance issues. We did not meet the goals and of course that has consequences. What we focused on was reducing overhead staff and instead also we have kept high performers with customer facing roles. that has also been promoted and has taken over management responsibilities now. The result of this is that we have achieved a leaner and more effective organization, which we believe will be performing very well. And we've seen also that the sales, the remaining sales staff, we kept out of the customer facing staff, we kept four out of six. uh we are performing we're doing our best months here uh at the end of the quarter four and the beginning of of uh first quarter uh at the the current fiscal year so um yeah it's always sad to say uh goodbye to colleagues uh that has uh served as well and be very loyal and performed well but uh i think with this we have strengthened our position and going forward significantly Overall, this will give us a 13 million per year cost saving. Uh, and, uh, the majority of that is in the U S organization. Uh, it's also an 8 million Swedish in the restructuring costs, which, uh, was, uh, booked at, uh, the fourth quarter for, uh, fiscal year 2324. With that said, I touched upon some numbers, but I will hand it over to our CFO, Anders Morén, who will go through the financials. Anders, please.

speaker
Anders Morén
CFO

Thank you. So, a few slides on financials.

speaker
Anders Morén
CFO

You can see here our Total year sales ended up at 7.3 million. That's a miss versus our 10 million target that Anders was talking about. We're of course not happy about that. But if we look down at the Q4 sales, that was 1.9 million. That's 225% growth versus Q4 prior year. And for the full year, it was 115% growth versus prior year sales of 3.4 million Swedish kronor. So we are going in the right direction, a little bit slower than anticipated. We zoom in on the US IVD sales, the same pattern here. We sold 423,000 Swedish kronor In Q4, that's more than the year-to-date number for Q3, 365. So it's more than what we had sold year-to-date when we closed Q3. Total sales, 788,000 Swedish kronor. And this good trend, I think Anders mentioned, that continues now we see also in May and June. So we're quite happy about the trend. A slide on the cash position, 79.4 million Swedish kronor when we closed Q4. Rounding up with a look at the net operating cash flow by quarter, it was minus 25 million in Q4. Of course, the 8 million restructuring cost that we accrued for in end of q4 because that was the decision was taken on the 23rd of april so we accrued the 8 million that also inflates both the working capital and operating cash flow before changing working capital but net minus 25 million so that's basically in line and we we have the plan is that that should be improving us as our cost saving reductions comes in and also a sales start coming in following the trend that we just saw on the previous slides. Headcount, we were average 37 heads for the full year. As of May, we're down then to 27. So it's 20 headcounts in Uppsala and seven in US. So that's minus five on each of the sites that we are operating in and all in all 30 million saving, I think, about 25 of those 30 comes from the US restructuring and 5 million coming from the Swedish side restructuring. So with that, I'll hand over to Hector that will walk us through the US update.

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-

Investor presentation