Biovica International AB (publ)

everyone and welcome to the Bayerika interim report for our third quarter. Today, it will be me Anders Rylander, Warren Cresswell, Henrik Winter and Anders Mohren presenting and we have Helle Fisker also helping to produce the webcast. And the agenda for our presentation is first a short introduction, a general presentation about the company by me, and also the highlights from the quarter we just closed. Then Warren will go into the details a little bit more around our US business and give an update. Henrik will do the same for our pharma services business. Anders will round off with the financial update from the quarter. I'll do a summary and then we will open up for questions and answer session until the end of the hour. So we expect this to take an hour. The entire presentation and it will start with our analysts and then it will also take questions through the chat feature so you can all the time from now on during the presentation submit your questions you're using that chat. uh feature and uh if you want to remain anonymous you should click that checkbox because we will then post the question when we are when we answer them okay um so let me start with the the introduction of the company in a few slides very uh a great overview so uh our core product that we developed and is now bringing to the market is DIVITUM. And DIVITUM is a blood-based assay that measures cell proliferation. And as you all know, cell proliferation is a hallmark of cancer. And by measuring cell proliferation, we can provide very important information for the patient and the treating physician. The application we have chosen initially is monitoring our treatments within metastatic breast cancer, where there's a very strong unmet clinical need currently. And we have data that shows that we can add real value. And now we also have results from being used in the clinic as well. So it's very encouraging. Also, the demand is further highlighted and strengthened by initiatives, several initiatives by the FDA called Project Optimus, for instance, that requires efficiency and monitoring biomarkers, and Divitum, that's precisely what Divitum can offer. This is, of course, super important for the patient, making sure that the treatment that you're on is really effective, so it's easier to tolerate its side effects, but also from a health economic perspective, as these treatments are priced at a pretty significant level with over $10,000 per month. and patient within the metastatic breast cancer area. And of course you want to make sure that this money is well spent. The product has been throughoutly documented in more than 30 clinical trials that has been peer reviewed and published. The majority is within breast cancer, our first commercial area. And they, but we also have proof of concept data outside of breast cancer in other cancer areas. And it supports the use as a clinical biomarker test for monitoring of treatments in cancer, but also have a strong prognostic value of how the disease will progress, both in earlier phases and the metastatic setting. These collaborations have been done together with some of the leading oncologists and the institutions in the world, which of course is important for us in order to reach out with the message, convincing all the oncologists, the potential customers out there using this for their patients. And as I said, we don't now only have the uh data from clinical trials we now see this works very good in the clinical setting which warren will give some very exciting sound spot this is of course the foundation for our commercial activities starting from getting the 510k clearance from the fda which we have as well as getting reimbursement and in the end driving demand for the product When it comes to the market potential, we have, as I said, focused initially on the metastatic breast cancer setting. And when it comes to territories, we initially focus on, first of all, the US market and also selected markets in Europe, where we primarily focus on the big countries in Europe and the Nordics. This market potential is estimated based on an average price in the US at $400. And also now being on the market and receiving price for Medicare, we are more certain than ever that that assumption holds, which of course is very, very important. If you look at the next level, it's the pharma area, pharma services, where the business model actually consists of three different phases, which Henrik will go through. And we also see that there is a huge potential and we have a big, a strong market position, especially within companies that are developing so-called CDK inhibitors for the future. So it's very exciting. And beyond that, we see several indications where there's a great potential One area that we could mention is the use of immunotherapies and to monitor them in a good way, where we have similar clinical needs as within the breast cancer area, where we also both have data together with Karolinska that we published and also an ongoing patent application. That about the market potential. If we now move on from the more general information to the highlights from this third quarter of ours, I have divided them by business area. First of all, US, I would say the most important milestone from the last quarter was the decision that we got that we now have been included in the Medicare price list starting January 1st. And we are already seeing payments being made by Medicare on that new price. level, so it's really, really good. And another major milestone for us was the yearly San Antonio Breast Cancer Conference. This year we had three posters or our collaborating partners, different universities, Yale and Washington University in this case. presented data on our products on this conference. And it's an excellent, excellent opportunity for us to meet world-leading oncologists to reach out with our messages about the value of the product. In Europe, we continue to sign commercial agreement, both for the Nordics, a company called Axelab, and now the latest one, Palex, that covers Spain and Portugal. We also did a rights issue that we closed by end of year that enables us to continue the market introduction of the assay all the way to making our goal of becoming cashflow positive during 2025. And after the end of the third quarter, we continue in the US to launch a new trial with Washington University, which also has a great potential and value for us. which Warren will cover, and the pharma services area is continuing to develop well. We have signed two master services agreements, and on those agreements we have also taken the first work order of a collective value of 2.9 million Swedish kronor. So with that said, I'd like Warren to take us through the US status.

Great, thanks a lot, Anders. I'm really excited to talk about the US business and give an update in regards to the positive progress that we've made in this last quarter. Through my presentation, I'm really going to focus on five separate topics, one of which is sales and contracting performance. I'm going to talk about the reimbursement milestones and progress we've made there, along with regulatory progress. I'm going to touch base on clinical activities. And then I'm going to end the presentation on real-world patient data using Divitum. And what this will do is really illustrate the clinical utility of Divitum. So look forward to that. Next slide, please. So with respect to sales performance, we had a very good Q3. Our sales performance doubled over Q2, which is fantastic. but also which was very interesting was that we were able to get additional medical institutions to order Divitam as well. So that number went up from five. So prior in Q2, we had seven ordering institutions and now we have 12. So that's very, very beneficial to our business. There are two very good indicators as well of our business. One of which is that we have 93% of physicians that have ordered Divitam has ordered more than one test. And this is a really good indicator for us. The other thing is that when we take a look at patients that are being tested with Divitam, we have 47% of patients to date that have had more than one Divitam test. And many of these have had several. That number will probably go up as well because we've had a number of patients, new patients in the last month or two And they will most likely get additional testing as well moving forward. I can tell you in my experience in this particular market, that number is incredibly high. And that's my experience and my team's experience. So I think these are incredibly good indicators for our business that the clinical utility with Divitum is very significant in the marketplace. And we look forward to future growth as well. From a hospital contracting perspective, our goal, our ambitious goal at the beginning of the year was to sign 10 contracts. To date, we've executed three. The important thing here, though, is that we have about 14 in the pipeline. Many, many of these are NCI or NCCN designated cancer centers. And many of those as well are currently ordering Divitum for us. We're just submitting those claims to the standard reimbursement process. So we'll see moving forward some of these getting across the finish line. Unfortunately, some of these institutions, unfortunately, they're very, very large, and it takes a bit of time to get those contracts through the system. So we're very encouraged with the progress we've made both on the sales side of things and on the hospital contracting side of things. Next slide, please. From a reimbursement perspective, we're really happy about the progress that we've made here. I think the takeaway messages is that we're getting paid in all three separate channels, which is fantastic. If we take a look at number one, which is Medicare, as Anders indicated, our PLA code was priced at the end of last year and that pricing went into place or was activated January 1st. So all divotum tests as of January 1st on, we submit a claim using our PLA code with this particular price, and we've been getting paid on it, which is absolutely fantastic. So we're starting to get those claims, those payments in the door. Secondarily is private insurance. And with private insurance, private insurance has kind of two components, one of which is a person that's on On private insurance, the other is a person that is on Medicare, but is managed through private insurance. That's called managed Medicare. And we've been getting paid on both of those customer segmentations within private insurance as well. All of the managed Medicare claims have been paid at the Medicare price, which is fantastic. And in fact, the private insurance claims, we've been getting paid more than we've expected. So this is fantastic news as well. And then from a client bill perspective, we've been getting paid what we've contracted and that's what our expectations were. And that is still our core strategy within our businesses, move as much business as we can into that hospital contracted channel. The two indicators here that are really, really impressive is with respect to all of the claims that we've made through Medicare and private insurance, along with client bill, there has been zero claim denials based on medical necessity or clinical utility. And this is unbelievable, quite frankly. If you take a look at other organizations, especially in the molecular field, you will see claims denial rates up in the area of 50%. We've had zero. This is fantastic. We haven't even had to submit an appeal yet to get paid. So I think all of the work that we've done, whether it's getting the PLA code, the pricing of the product, the clinical utility of the product, It's been, I think, very spot on for the organization. And I think the other point, as Anderson mentioned just previously, is that when we take a look at the payments through these three channels, whether it be Medicare, private insurance or client bill, that blended average of payments, we believe that we will be at that $400 price range as these channels develop based on the payments that we're receiving today. So we're very, very encouraged by that news. Next slide, please. With respect to kind of our regulatory side of things, as I've reported in the past, we do have a CAP-accredited CLIA lab. We're Medicare credentialed. Up till now, we've been working on licenses from different states so that we can provide divitum. And today, we can actually provide divitum to 49 of the 50 states plus Washington, D.C. So the only remaining state that we are working on is New York State. And we've already submitted all the necessary information to New York. We've interacted with them. We are only waiting for their audit date at this particular point in time. We've spoken with them, I think it was two weeks ago, and they indicated that before the end of H2, their audit team will show up, audit us, and then we can expect to be able to be licensed to do business in New York State, which adds another 20 million lives. So we're really encouraged by that. This has gone incredibly smooth for us. Next slide, please. So with respect to clinical, clinical is one of the most important areas of our business. We've just added a third prospective interventional trial. Today, we have three of them. So we have one from Yale University that we're working on, and that really identifies potential medical compliance and drug-to-drug interaction. And kind of the secondary endpoint, I would say, is is dose adjustment, and this trial is up and running. We're seeing samples roll through almost on a daily basis. The second trial is through Washington University in St. Louis, also known as WashU. That trial is also recruiting patients, and that's called TK Impact, and TK Impact really explores how to use Divitam and how oncologists change how they manage those particular patients. One of which is, should they do imaging earlier? Should they hold back on imaging? What other type of testing should be done? So this is a very, very important clinical trial for us as well. And thirdly, we just signed a clinical trial called Better. This also is through Washington University. And with this particular trial, this really focuses on early therapeutic switching when patients are no longer responding. So when a patient gets tested and they have a very high TKA level, one of the things these physicians will do is understand, do we switch these patients to another CDK4-6 inhibitor or do we switch to another line of therapy? All three of these are very important to us in regards to the data really helps us with supporting the clinical utility. We will use this data from a guidelines perspective, and we've made really great progress here. The other thing that we're doing as well is we're taking a look outside of metastatic breast cancer because early indications indicate that Divitam will work in not only earlier stages of breast cancer, but other disease states as well. And one thing we're doing is we're looking at the adjuvant breast cancer setting. And this has been really the number one thing that medical oncologists have spoken with us about. So we're doing a retrospective analysis of a CDK4-6 inhibitor clinical trial. This is a big one. This has 1,250 patients and a little bit over 3,200 patient samples. We're evaluating those now and we believe that the data readout will be before the end of H2 2024. We're really hoping that we'll be able to have an abstract at San Antonio Breast Cancer Symposium. So stay tuned there, but we're excited about the preliminary data that we're seeing. The real benefit with the adjuvant market is as well as that it's an enormous market. It's significantly larger than metastatic breast cancer. from a sales perspective, it's the same call point. So those medical oncologists that are getting used to using Divitam with their metastatic breast cancer patients, they're actually measuring, managing a significantly large number of adjuvant breast cancer patients as well. So it's the same call point. So it's great that we've educated or educating folks today on Divitam, those medical oncologists. They'll be the same medical oncologists that are managing those adjuvant patients. In addition, we use the same product number for our test. We use the same PLA code number for our test and we use the same price for our test so that all of alliance perfectly with regards to our business. So we're very, very excited about about this and in the work that's being done there. Next slide, please. So I'm going to. I'm going to talk through four separate. Case studies here. These these are this is data from from real patients, real data. And as you can see on the bottom of each one of these charts that will pop up, you can see that the data is very, very recent. So in this particular case, this is data from October, November, December. All four of these case studies are women with metastatic breast cancer that are hormone positive. If we take a look at this first one, this patient has metastatic breast cancer, is on a CDK4-6 inhibitor plus an endocrine therapy. The patient is feeling very good. No issues whatsoever in that regards. They had a CT scan and the CT scan did not show any disease progression. They had blood chemistry work done. Liver enzymes were slightly elevated. This particular oncologist has been using DIVITUM and they decided to try or to test this particular patient. The value came back incredibly high. It came back at over 2,000. And so instantly the medical oncologist thought, well, based on the liver enzymes being a bit high, but especially because the TKA level was so high, let's do a liver biopsy. They did a liver biopsy two to three weeks after that Divitam score, and they found liver metastases. Now, those liver metastases were confirmed to actually be triple negative breast cancer. So That's super important because how you manage triple negative breast cancer is different from hormone positive breast cancer. So immediately the oncologist switched courses of therapy, moved from a CDK4-6 inhibitor plus an endocrine therapy to an immunotherapy plus chemo, and that patient is responding. And the doctor told us, you know, without Divitam, I would not have done a liver biopsy. Imaging did not show disease progression, and it's incredibly important for us to be able to put these patients on the right therapies to maximize their overall survival. So this is absolutely a huge win for the patient. Next image. Thank you, Anders. The next one I want to talk about is dose reduction due to tolerability issues. So in this particular case, a patient was on abemacyclib and fulvestrin. they had an issue with they had a side effect in this particular case this patient had diarrhea and and it was not they were not able to control it unless they took the patient off this particular therapy so they took took the patient off the therapy they managed the diarrhea but then the oncologist said you know before i switch cdk46 inhibitors i'm going to try to dose adjust this patient down to see if we can manage the tolerability side of things They did that. They took that patient. Well, we tested the patient off therapy. You can see it's 408, very high number. They put that patient on a lower dose of Abema and the value dropped significantly down to 40. And this gave the peace of mind to the patient and to the physician that the patient was responding to this therapy. So again, another great demonstration of clinical utility of Divitam. The next image, please. This is one where a therapeutic switch was made by the medical oncologist. So in this particular case, this patient was on ribociclib plus an anastrozole, and they had an issue, they had a tolerability issue. They actually had four separate side effects that they were facing with this particular drug, one of which was nausea, and they could not manage that. So the medical oncologist made the decision to take the patient off this therapy We tested the patient when they were on the therapy and they were responding very, very well at 18. This is incredibly low score, but, but they had tolerability issues. So when they took the patient off that score shot up to 265, which is a clear indication of cell proliferation. Then they put the patient on Pelvociclib plus an anastrozole, and the value dropped down significantly, dropped all the way down to 38, and then you could see that one month later it dropped to 23. Very, very low scores. In this particular case, the patient could tolerate Pelvo better than Ribo. and they're not suffering from any side effects. So again, great way to be able to see this. And there's no way a doctor would be able to see whether a patient is responding other than realistically doing imaging and waiting for disease progression. So again, very good clinical utility. And if you can provide the next image as well, Anders. Final one, I think this is fantastic for the patient, is this patient has been on ribo and fulvestrin. In this particular case from October, November, and December, you can see these values are incredibly low. And in fact, I know for a fact that with this particular drug, the patient's on therapy three weeks and then off therapy, they have a drug holiday one week. These samples were taken during their drug holiday and you saw no rebound effect of that value going up. So not only is this patient responding incredibly well to this therapy, But also this really aligns with Project Optimus from the FDA where the doctor is looking at instead of providing the maximum tolerable dose, maybe we should dose adjust down and give them minimal effective dose. And again, another clinical utility of this product. So I just wanted to share this with you. I think this illustrates the different utilities of Divitam. And this is, I think, why myself and the entire organization is just so motivated and energized of what this can do to help women with metastatic breast cancer. And with that being said, I'm going to pass this over to Hendrik.

All right. Thank you very much, Warren.