Biovica International AB (publ)

Thank you start.

Hello everyone and welcome to the earnings call for the second quarter of Bayvik has broken fiscal year for 23 and 24. So we can shift slide. Uh, the presenters for today will be first. It will be me, Anders Rulander. Followed by Warren Creswell, Henrik Winter and Anders Morend. And the agenda for the call is a short introduction from me, and then I'll talk about the highlights. Then we'll dive into a US update with Warren Creswell. And Henrik Winter will provide an update about our pharma services development. Anders Morén will provide an update about the financial status before we have a summary by me and the Q&A session. And you can all post questions using the functioning Teams. And if you want to remain anonymous, you can do that as well by checking that checkbox. And at the start of the session, we will let the equity researchers in from Redeye, Pareto and Kempen. So they also would have the opportunity to ask questions, follow up by questions that we received from other participants. So I will start by talking a few words about our product. So we are all on the same page here. So the product is called DIVITUM, stands for dividing tumor. And with DIVITUM, we can, from a simple blood test from the patient, measure cell proliferation. And in the cancer, that is essential and important information as cancer grows through uncontrolled cell proliferation. So DIVITUM can provide important information both before and during treatment, information about the aggressiveness of the disease and also provide quick response if the treatment is effective or not. We have in clinical trials shown that we can provide such information if the treatment is effective or not only two weeks into treatment. That is a significant improvement versus imaging, which is the standard method being used today. which requires three, four months before evaluation of progression is typically done. We've also in another clinical trial shown that we on average can provide feedback about progression around three months on average quicker than with imaging. So we have a very convenient tool for monitoring of cancer therapies in the metastatic setting. We've shown several clinical trials. Talking about clinical trials, here's a summary of the clinical trials that we have published so far together with our partners, or to be correct, it is the partners that has used our assay and used it in clinical trials that have made the publications. Before that, they'd be peer reviewed and published in scientific journals. This is, of course, essential for us, having data proving the value of the product. These trials are shown that the DIVITUM is strongly prognostic, both in local setting of cancer, but also in the metastatic setting where it's been shown to be prognostic both for progression and overall survival. And it's also been shown to be an excellent monitoring tool where we've been able to follow patients and take in repeated samples over time. Our focus area is the breast cancer area where we have the majority of the data, 14 studies and over 3000 patients. We also want to highlight the collaborating partners. We have really strong key opinion leaders, some of the leading ones in this area, especially within the breast cancer area that has performed these trials at some of the most well-renowned academic institutions in the world, such as Mayo Clinic and Johns Hopkins and then Dana-Farber, et cetera. This is of course important because these people and these institutions, they have impact when they reach out to others and present the results of the clinical trials. When it comes to our go-to-market plan and the market potential, we'll talk a little bit about the plan and the different areas. Our focus is initially now to commercialize the product for use as a monitoring tool within metastatic breast cancer, both on the US market, where we have an FDA clearance since last year, and we're now in the ramp up of the commercialization phase, which Warren will talk more about. In Europe, we also have a very good start where we have signed several agreements with partners that is providing analysis services and also has a sales force working against oncologists on certain European markets. Another area with great potential is the pharma services area where we serve pharma companies using our product when they develop new therapies within the cancer area. something that Henrik will dive into and explain a little bit more where we stand. We've made great progress there as well. Looking further ahead, we have also great opportunity and potential to widen the use outside of the breast cancer area into new indications. We already have data on metastatic malignant melanoma and in combination with immunotherapies, we also see potential within lung cancer and prostate cancer. So there's a great potential for the product and we have also made great progress during the last quarter where we are in early phase of our commercial journey of commercializing the product. If we dive in to the second quarter of our fiscal year and the highlights that we've had, it's been quite a few actually. It's been that many that we have now been forced to categorize them. If we start with US and clinical, Warren will cover these a little bit more in detail. But we made progress when it comes to direct bill agreements directly with US hospital or hospital networks, you might say, because we are now covering around 50 hospitals with these three agreements in three states in the US. We also made a PR about the preliminary decision with the gap fill process for CMS. And then after the end of the period, we made a new PR that in the end we concluded or CMS concluded that we'll go with a quicker method called crosswalk, which means we'll have a price or be included on the Medicare price list from start 1st of January next year, which is great news. Warren will also explain a little more what that means. We're making progress when it comes to the lab. We got the CAP accreditation that opens up opportunity in certain geographical areas and at certain also private insurers, et cetera, which Warren will talk about. And we are continuing to strengthen our clinical data by initiating new clinical trials. So a lot of progress on the US area this quarter. Looking into pharma, we have now a portfolio of projects and we can see that they are growing and we can see that revenues are keep growing. Henrik will give you some little more guidance around what we've done there and also how we've been able to, within which areas we've been able to grow our business there. And also when it comes to the more administrative PRs that we've issued, we've communicated that we will do a rights issue that's partially guaranteed and we're progressing with that. We've also carried out an EGM in that process. And then the last news before end of, or sorry, after the fiscal or after the Q2 ended during November, we announced that we signed a commercial agreement for Europe. And if I move into that slide specifically, it is with a Danish company called Axelab. A company is growing very fast and is focusing on diagnostic or sales of diagnostic products. And they have a customer facing team of 25 reps within sales and marketing. And they are planning to expand that when they're bringing in dividend to their assortment. So this aligns very well to the kind of partners that we would like to team with that is successful, fast growing within oncology, has a sales force, has the competence and the drive to make us both successful. And we've set aggressive targets to, within three years, realize 15% of the market potential on this market. And I think also we have some really strong partners when it comes to the clinical setting with Karolinska and we have ongoing trials also with Krista Hospital in Manchester that Swedish hospitals like the one in Linköping also is part of. This is great news also for the European area. All right. Then I'll let Warren on stage. And Warren, if you please, can take us through the US status and walk us through what happened during the last quarter.

Great. Thanks a lot, Anders. I really appreciate it. There you go. We continue to execute our U.S. strategy, and I think this quarter has been not only productive, but I think very exciting for the organization as well. Throughout the presentation, I'm going to talk about a number of different topics. I'm going to talk about Medicare pricing that was recently established. I'm going to talk about the three hospital contracts that Anders alluded to. I'm going to talk about regulatory progress we've made with our CLIA laboratory. I'm going to talk about clinical trials that are ongoing in the US. And then I'm going to finish with some feedback that we've received from medical oncologists that's been very positive that I wanted to share.

Next slide, please.

So Medicare pricing, this has really been part of our overarching reimbursement strategy is to work with both the AMA and CMS to be able to establish a price for Divitam. And we started this process early in the year. We worked with the AMA. AMA is really the gatekeeper of all coding in the US. You need to have a code to be able to provide essentially an invoice or a bill to Medicare or to private insurance. And we did establish a proprietary laboratory analysis code. That code is actually specific to both Divitum and Divitum being run in our San Diego based CLIA laboratory. So what that means is with this very unique code, if there is a competitor that decides to develop a TKA assay, they're not able to use our code nor are they able to use our price. They themselves would really have to start from scratch. So it's really unique to us, our product and our laboratory. We also were working with CMS. CMS is the one that actually is a part of the organization that determines the price for a particular product. So we worked with the CMS subcommittee And during that discussion, there's really two paths that we could take. One is called crosswalk, where we compare our product with similar technology to establish a price. Or there's another payment methodology called gap fill, where you really have to start from scratch and prove the value of your product. That's a two-year process. In September, CMS issued a preliminary payment determination. WHERE EVEN THOUGH THE SUBCOMMITTEE VOTED IN FAVOR OF CROSSWALK, CMS ENDED UP DECIDING AFTER FURTHER EVALUATION THAT IT WOULD BE BEST FOR US TO FOLLOW THE GATFIELD PAYMENT METHODOLOGY. AFTER THEY INDICATED THAT, THERE IS A TIMETABLE WHERE WE CAN PROVIDE SOME ADDITIONAL INFORMATION AND ASK FOR RECONSIDERATION. IT'S WHAT WE DID IN OCTOBER. AND AFTER THEY TOOK A LOOK AT THE INFORMATION THAT WE PROVIDED AND THE ARGUMENT WE PROVIDED, This month, in fact, last week, they did reverse their decision. They made a final payment determination, and they indicated that we could pursue crosswalk. And what that means is January 1st, 2024, so just over one month away, Dividend will have a price of $322 per test for Medicare patients, and that is really a huge milestone for us here in the U.S., Now I know Anders has given guidance in the past in regards to having an average test price of $400 per test. And this works in perfectly in our equation because we had calculated $322 per test. When we add in private insurance and when we add in hospital agreements, the net is $400 and maybe even a little bit more.

So I think we're doing a really great in that regards. Next slide, please.

In the quarter, we did sign, execute three separate contracts. Now, these three separate contracts aren't necessarily for three hospitals, as Anders had indicated just a few minutes ago. This really encompasses about 50 hospitals because these hospitals really act as networks. The first one that we signed is based in Arizona, but they really do cover the southwest region, and they're one of the largest healthcare providers. They themselves have about 30 hospitals in their network. And we're just starting to see samples come in through some of those hospital institutions now. The second agreement is with the largest healthcare provider in Missouri. This is a NCI-designated cancer center. They have 18 hospital laboratories, and they're working through really kind of the final details in regards to logistics, internal logistics, before they start sending samples in, but the contract is in place and executed Thirdly is a contract with really a world-renowned cancer center. They're an NCI-designated center. They're located in Florida. They serve patients from all 50 states, and we are actively receiving samples from that particular institution. The target that we have in the U.S. for this fiscal year is to be able to sign 10 hospital contracts. We do have a pipeline of institutions that we're working with. And one of the things I want to mention as well is that the real takeaway with these contracts is we've pre-negotiated a price, so that is in place, but also the fact that each one of these institutions has indicated that there is clinical utility with Divitam, which enables their oncologist to order the products. And that's a huge win from our perspective.

Next slide.

From a regulatory progression perspective, back in February, we worked very hard to get our lab CLIA certified. We achieved that. The following month, we were credentialed by Medicare, which means that we could receive samples, test those samples, and invoice Medicare And then in October, we're very pleased to be able to earn our CAP accreditation. And so this is a lot of very hard work that's gone on within the laboratory over the last year to be able to get CLIA certification, you know, being credentialed by Medicare and being CAP accredited. So today, what we're able to do is we're able to conduct business in 48 of the 50 states, and we anticipate The 49th state that we can do business in is in Maryland, and we anticipate that being happening, getting a license anyways in the next month or two. And we're working closely with the state of New York. New York is a bit of a longer process. They do require CAP accreditation before you can apply for a license. So we're working with them. The timeframe there is a bit longer, but we anticipate kind of late H1, early H2 to be able to get a New York State license and we'll be able to then serve their 20 million people that are in the state of New York.

Next slide, please.

We are also actively engaged in prospective interventional clinical trials. And really in no particular order, we are working with Yale University and with Yale, the clinical trial that's open and recruiting patients. It's for both drug to drug interaction. So they're looking for patients that are taking a therapy, specifically CDK4-6 inhibitors. and where we see a high TKA value where maybe the patient isn't responding to the therapy. And one of the things that physicians are looking at is the drug-to-drug interaction. What's that impact to the efficacy of the drug? The other side of this is also looking at dose reduction. So when you have a patient responds incredibly well to a therapy, is there an option to actually dose reduce that patient so that the drug is a bit more tolerable? That study is up and running. The second one I want to talk about is with Washington University in St. Louis. This trial is called TK-Impact, and this is a trial that looks at real-time biomarkers of tumor response. And again, this is patients that are on CDK4-6 inhibitors that are hormone positive that are metastatic breast cancer patients. In this particular trial, they're looking at not only our product, DIVITAM, FeminiKinase, but they're also taking a look at other biomarkers as well and seeing how a physician may act differently if they had a TKA value that was elevated or declining versus other biomarkers. This clinical trial is open and recruiting patients. And in fact, there's an abstract that was submitted to San Antonio Breast Cancer Symposium, and that will take place next week. And the third one is another clinical trial through Washington University, and it's called the BETTER trial. And with this particular trial, it's biomarkers driven early therapeutic selection. So when a patient goes on a therapy, we look at the thymidine kinase level at baseline, and then we look at it at cycle one, day 15. And based on the results of those two tests, the clinician will make a decision whether they keep the patient on a particular therapy or they make a decision to change the therapeutic selection that they've made for that patient. That trial is opening in early H1 of next year. So we're really excited about this. The real takeaway from these clinical trials is that, you know, one, it gives us data where we can understand where we can potentially expand the label of our product. It also provides clinical utility and it also helps from a reimbursement perspective as well.

Next slide, please.

And then lastly, I'd like to end with feedback we received from medical oncologists and the feedback has really been overwhelmingly positive. There's three particular comments I want to review real quick. One of which is doctors indicating that the test really provides confidence, not only to the physicians, but also to the patients. So one oncologist located in the Southeast indicated Receiving a Divitam TKA value of less than 250 gives me the confidence that my patients have a low likelihood of disease progression. And that's really exactly on label what we want both physicians and patients to experience. The middle one is really early determination. So we have physicians, this one particularly in the Northeast, that from the baseline test to the cycle one day 15 results. A reduction in TKA value suggests that my patients are responding to therapy. So it really gives them an early understanding, like Anders mentioned before, that we can see things in a couple weeks results. And thirdly, is really this personalized therapy approach, which is providing patients with the lowest effective dose rather than the highest tolerable dose, personalizes therapy for my patients. And this is really in line with Project Optimus that the FDA has been talking about, where they're looking at dosing patients, not based on maximum tolerability, but minimum effective dose. So it feels like we're exactly in line with where the market is shifting there as well. And with that being said, I'm going to hand the presentation over to my colleague, Henrik Winther, and he's going to give an update on pharma services.

Super. Thank you very much, Warren. Yes, so I'll provide you with an update on what we have achieved during Q2 within our pharma services and collaboration business. So for those of you that have actually seen our presentations before, this slide might seem familiar. It really shows the stepwise approach we use when we onboard pharma. So typically, they start out by evaluating our technology. through an agreement, a T-Stand we call it. When they have actually realized the potential of the assay, they typically move into step two, where we sign a master service agreement with them, allowing to actually run several projects with that pharma partner. And then at some point of time, when we have run a couple of, or quite a few, perhaps, of these projects, um farmer will start the discussion about what is you know the potential of actually customizing your assay towards our drug so that's you know the third step the the cdx collaboration and then finally you know it should lead to uh you know products uh by weaker products brought to the market and that's really the goal of this business is you know getting new products to the market so if you look at the status on the slide here in the lower part uh what we achieved uh during q2 it was a you know great continuation of you know what we actually also or the the positive trend we saw in q1 um so totally you know you can see we have now 21 projects and in parentheses uh here you can see you know how it looked in q1 so we uh went up you know three projects Even better is actually that if you look at a little bit of above and look at the thesis and the MSA, we managed to go from 12 MSA projects to actually 19 projects now in Q2. And that's really because, you know, some of the thesis they turned into master service projects. And then, you know, we also sign, you know, two new thesis with Pharma. So totally Q2, we have 21 projects. We also signed one new master service agreement during the quarter. So very, very positive progression. If we dive a little bit deeper into what happened during Q2, I have a few highlights here. So financially, we actually grow 35% from Q1 to Q2. And if we compare to last year's Q2, we had 130% growth. So really a strong Q2 in this part of our business. A couple of other highlights is that we saw an increased interest from Tier 1 oncology pharma companies. And I have a quote here from one of these companies saying, they really said, I can't understand why we haven't used your biomarker before. The thing about Tier 1 pharma companies is that these are the companies that will really pursue the companion assay development, and therefore it's super important for BioVica to have these interactions with Tier 1 oncology pharma companies. Another trend we saw was that for many of these projects we have, We now have activities not only within the CDK4-6 inhibitors and also the second generation of those drugs. We actually also see activities within CERN's third and not the least immune checkpoint inhibitors, the ISIS. And if you take a look at the slide here, you can see that this is really broadening our total addressable market because we're moving outside breast cancer into other indications as well. So also super positive. And then, you know, the final point I bring up here is the fact that we had one company actually reactivating their project. This company is about to enter into phase two. And this is, again, you know, super positive to BioVica because phase two is exactly where we want to be. This is going to, again, you know, increase the likelihood of us being part of a CDX development activity. So overall, very, very positive Q2 on the pharma services business.

So with that, I'll hand over to our finance. Thank you, Henrik.

So a few slides on the financials. See if I can get this to move. Yes. So net sales for the second quarter was 2.6 million. Previous Same time, the second quarter last year was one million. So we have a significant growth year over year on the second quarter. Also, net sales year to date for Q2 or for the first six months of our fiscal year, we had 4.3 million in sales. You can see here the dark blue bars are current fiscal year and the light blue bars are previous fiscal year. So we sold 4.3 million this year and accumulated 1.5 million. You can see also graphically that we sold more this first six months than the full year for last fiscal year. And sales is mainly coming from the pharma services business. That's the pharma service in terms of test services to pharma companies, but also kit sales to pharma companies. A little bit on the cash flow. Cash is extremely expensive, so we are watching our cash very, very diligently. Operating cash flow before changing working capital was minus 24.5 million. Previous quarter it was 30 million, so we have a significant improvement there. Changing working capital this quarter was minus 3.9 million, so all in all it was 28.3 million q1 this fiscal year was minus 38 and a half so it's quite a positive trend there cash balance for second quarter 46.9 million that's basically in line with what we had last year last year we had a rights issue of 110 50 million, I think, and this year we have projected 120 million. Total headcount for the end of October was 37. Last year it was 27. You can see here that we have 24 out of these 37 in Sweden and 13 in the US. Last year same time in q2 we had five in the us so the main increase is coming from the us and that's the sales team that was employed first of december last year so with that i'll hand it back over to anders for summary and and q a thank you very much we sum it up so we have uh divitum um

very important product that meets an important, currently unmet clinical need, which is the ability to include monitoring of cancer treatments. And we have together with the key opinion leaders and from some of the leading institutions made scientific collaboration and clinical trials that has laid a foundation for our commercial journey, which we are taking now the first steps now a few quarters in and still relatively low volume but we see a very positive trend and progress both yeah all three areas us europe and pharma services and if you look forward our targets for the fiscal year that we're currently in 23 24 that ends in in by end of april We have the ambition to sign an additional seven of those agreements in total 10 and another agreement in Europe and in total sales more than double digits in Swedish kronor, so more than 10 million. And our long-term goal is to break even mid 2025 to become cash flow positive. And in order to do that, our sales projection is to have revenues of 50 million Swedish per quarter. And I think we're taking some important steps into that direction. It feels really positive. In order to take us to cash flow positive, we're now doing a capital injection, a rights issue where the subscription period starts tomorrow. So later today, the prospectus will be published. on our website. The purpose is, as I said, to take us to become cash flow positive. It is 120 million, which is partially guaranteed in the rights issue, and then an addition of 54 million in warrants that is effective during September next year. The subscription price is 261, and I am myself looking very positive on our future, so I'll be participating with 10 million Swedish kronor in this rights issue. Very, very good quarter for us and we look positive for the future. So with that, I'd like to open up for the Q&A session, see if we can get some of the equity researchers in. I can see that we had at least for a while Chen Sunli from Pareto in. I don't know if we can. Yes, I can see that he's now unmuted. Hey, perfect.

Hey, can you hear me?

Yes, I hear you well perfect.

Yeah, good afternoon and yeah, congrats with the process. So yeah, my purpose question will be what do you think about the process or timeline? So when the hospital contract is signed until you start receiving orders, do you need to clear anything? Yeah.

Yes. All right. So the question, I guess, is related to the U.S. market where we sign contracts with hospital or hospital networks. And we have a process in order to get those going. So maybe Warren, if we focus on Warren, Warren could elaborate a little bit on those steps and also timing.

Absolutely. And thank you so much for the question. I think With regards to getting a contract signed and then getting samples coming in, there's a process that takes place. Initially, when we engage a hospital, we talk to kind of a champion, a person that's very, very interested in using the product. We go from there to really meeting with the formulary committee. With the formulary committee, they really make the decision whether or not individuals in the hospital can order their test if there's clinical utility. From that point, we go through a contracting phase where we contract with the institution, negotiate pricing, terms of service, things of that nature. The fourth step is really the logistics side of things because internally when an oncologist wants to order a product, they need to know how. Is it built into their EMR system? Is it a paper order or what that may be? And then finally would be receiving the orders from the institution. So in some cases, you know, this process can can take can happen incredibly quick, and in some cases it can take a better time. Our commitment is always to be able to move as fast as we can, so we're really reliant upon our partner to move quickly. So in some cases we can contract and see orders in a couple months, and sometimes it can take us, you know, six months to get a contract signed and get orders coming in. There's no real standard. I think each institution is a bit different. We do see the contract that we signed in Florida. They are very active in sending samples in every week, whereas the contract that we signed in Missouri, it's taking them a little bit of time to get systems in place. I hope that answered your question.

OK, perfect thanks. And for those 10 hospital conscious that you aim for for the fiscal year, to which extent do you think they will be able to cover the US hospital chain? Would they be able to cover the majority or what kind of portion that you are thinking about?

Yeah, so the hospitals, those particular 10 hospital contracts will will cover will not cover the entire the US. The US is enormous obviously, but it will certainly align with the revenue forecasts and the you know the financial commitments Anders has made. So in regards to that, I think that's how we we tend to look at it. You know, at some point in time, I think when we. As we progress the business, then we reassessed and we take a look at other institutions. We do have a deep pipeline of institutions that we want to sign contracts with. There's also a balance kind of from a resourcing perspective as well. But I think certainly those 10 contracts and the goals that we've put in place align with the revenue projections that Anders has shared with the market.

OK, thank you. Maybe just the last question. So how do you expect the sales development or the distribution between a direct bill hospital contract and the Medicare related sales over the coming years? So I guess the hospital contract will start first and the Medicare sales will come in later, maybe in a couple of years. Is that correct?

There's three channels that we will get paid from one will be the hospital contracts one will be directly through Medicare and one will be through private insurance and all three of those avenues or those payment channels are open today so we've submitted claims to private insurance and we've been paid we're submitting claims through Medicare and we anticipate being paid by them and through the through the contracts themselves our core focus is really working with hospitals to contract with them directly. So I would foresee there being greater revenue, most likely through hospital contracts. But it'll really depend on the mix and how it develops moving forward. But certainly as well, one point I want to make is that the Medicare patients, those patients you know, certainly as we contract with these institutions, those institutions will be responsible for the billing of those particular patients. When we receive a sample, oftentimes that information is blinded from us. So we run the sample, we report the sample results back. It could be a Medicare patient, it might not be a Medicare patient, but we'll get paid the contracted price. So most likely the revenue stream will be the greatest through the individual contracts.

Okay, perfect. Thanks for taking my questions.

Great.

Thank you very much, Jen. I'm asking Helle here who's helping us with the production. See if we have, if we can get Johanna Niers also into the call. I see that you're working on that.

Yes, I have him here on the phone and I'll just put the loudspeaker on. So let's see. Yes.

Okay, let's have a go.

Love you all.

Excellent. Okay, excellent. issue or question regarding the US sales and also a bit regarding the cost initially. Some of the OPEX costs came in slightly lower in this quarter. Is that a level that is representative moving ahead or is this sort of a lower quarter for some reason?

No, I don't know if if it should do cost, Anders. OPEX.

Hi, Johan. Since we have agreed now with the US team and the rest of the team regarding our cash out bonus to have that on rather equity-based bonus, we released that accrual that was about 3.8 million Swedish kronor that we had accrued in Q1. We have released now in Q2. So you have that variance between the quarters. And we haven't initiated and we haven't the time to initiate the new equity bonus program yet. So we haven't started to accrue any IRFS2 costs associated to that equity program yet. But from a cash flow perspective, I think we are definitely on a better trajectory than we were before we had this agreement with changing cash out bonus to equity bonus. But there will be coming in an equity bonus accounting cost, if that makes sense, going forward when we have this program in place. And that will be probably somewhere in January, if that makes sense. Was that answer to your question?

Yeah, thank you. Yes, that's useful. So cash-wise, you're on a sort of more modest level. And we also noticed that Anders intended to defend a reasonable stake interest in in in the ongoing rights issue yes absolutely yeah and also to warn um it's clear that the direct bill would be very important especially in italy presumably that we should expect a higher average price and also what sort of support will be necessary to drive the sales channels. Presumably, you need to encourage sales direct build.

Alright, so direct bill questions. See if I can repeat it. See if I understood it correctly and I see the folks isn't warm, so that's good because it's a US question so you can keep it on. So the question was direct bill. What kind of support do you need? Uh, you know to execute and if you can elaborate a little bit on price levels on direct bill versus Medicare, I guess then weren't.

So with. To execute these contracts, there's different pieces of this, as I just described, where we go through and we find the champion and work with formulary, contract, work with internal logistics. So where we're at now is where we spend a lot of time in the institutions talking to oncologists and driving interest and driving utilization of the product in these particular institutions. So that's our real focus with these hospitals that have been contracted. Once as these contracts get signed and the logistics are in place, it's actually much, much easier for us to do business with contracted entities than it is for us to bill on our own. Actually, the cost is much less to do business with with hospitals that are contracted versus us having to bill private insurance and Medicare and things of that nature. So so it's actually a bit easier for us once we get those contracts in place. But still, you still have to spend a significant amount of time in those institutions driving demand. These hospitals, they don't require oncologists to use the product, but what it does, it gives us the opportunity to build interest in the product, and it really smooths the way for oncologists to order the products in. So that's really where we're spending the core of our time. In regards to pricing, you know, all of the contracts that we sign are highly confidential. I can't share those with you, but certainly the price point is greater than the Medicare pricing I just shared. So the net net again will be somewhere around when we add in private insurance reimbursement, Medicare and the hospital contracts that will be at $400 or more on average.

Thank you and. Earlier you alluded to that for the current calendar, not calendar year, but the year Q and April, you expect higher ongoing volumes towards the end of this period, and presumably most of that will be related to direct bills. Is that how we should understand it?

I'm not sure.

I think I understood your question, where our efforts are going to be placed, if that was essentially the question. Our efforts are certainly around driving interest and adoption of the products. Our team is very focused on working with hospitals to not only drive utilization within those institutions that are contracted, but also we have quite a pipeline of institutions that we are working with to contract. So that will be our focus, you know, not only throughout this into this fiscal year, but also moving forward for quite some time. Did I answer your question correctly?

Yeah, I think you did. Thank you. Yeah, I think that's all for me. Perhaps a bit more color to your pharma projects and the prospects of promoting a project to the GDX state? What about the outlook for the rest of this period, or is that something we should expect later in 2024?

Yeah, excuse me. Yeah, I mean, what I can say is that, I mean, we're doing all we can, you know, to really progress on that front. You know, we're having these discussions, as I described, you know, kind of the third step there. It is only natural for some of these farmer partners, you know, that they really want to try, you know, customize our assay to make an even better fit to their drug. So we have the discussions. That being said, I mean, it is, of course, in control of the farmer partner. So I can't say, you know, more than that. But it is certainly our goal, you know, to to have a couple of these agreements signed as soon as possible as we can.

Okay, thank you. All right. Okay. Thank you, Johan.

We have Luisa. Or did you have any additional questions, Johan?

Yeah, we have Luisa from Van Kempen on the chat.

On the chat? OK. All right, so let's see, I have to put my glasses on to be able to read these. All right, so. The first one I think is published also so you all can read. I think the first one is really interesting. That is Project Optimus. I think Warren mentioned that briefly and maybe you can elaborate a little bit. The Project Optimus is what the FDA has launched. I think it was during 23 this year. And you can see on the conferences, there's a lot of focus. And the objective is to go from maximum tolerated dosing to minimal effective. And then, of course, you need an effectiveness biomarker assay like ours. And maybe if you can give some more background on how that has been met from the oncologists you're talking with, Warren?

Yeah, absolutely. And I think how you described it is is absolutely perfect, Anders, is that this is something that the FDA wants to look at is how do they essentially go to this minimal effective dose? And they're doing it, obviously, for a couple of reasons, one of which is has to do with tolerability of the drug and managing side effects. So as we've talked to physicians, you know, that have patients on these, you know, whether it's CDK for six inhibitors or chemotherapy drugs or, you know, IO therapies or things of that nature, You know, with all of them, they do have their own unique set of side effects and tolerability issues. And physicians really believe that if they can keep patients on a drug for a longer duration of time with it being effective, then the patient will have a better outcome. Some of these drugs, there's a kind of a litany of different side effects and oftentimes patients will be compliance issues where patients are not taking the drug because of some of these side effects. So I think it's a really good. A really good thing that the FDA is doing here is is taking a look at how can we do? How can patients be dose this minimal effective dose? Because most likely tolerability will be better managed and there should be better outcomes and in. The physicians that we've talked to, the medical oncologists we've talked to have been very aligned with this, and there's really been a lack of biomarkers that could help them out. And when we've talked to them about Divitum, this is something where most automatically refer to Project Optimus and are excited that this is a great opportunity for them to manage the TKA value to determine whether or not a patient's responding to a therapy. So I think this is a great opportunity for us where we really feel like we're at the right place at the right time with this particular product.

All right. Thank you, Warren.

I continue with Luisa's questions. Will you provide any guidance what we can expect for 2023-2024 sales? We just did that, more than 10 million we said. Could you provide more details on the progress applying DIVITUM in other indications? Our focus right now where we put the resources is primarily within breast cancer. So that's where we're driving demand and focusing our efforts. The three clinical trials that we talked about, how many patients, and the timelines around these studies. So it was IMPACT, it was the Yale trial, and it was the BETTER trial that we talked about here, which we also have been PR'd in previously. And in various trial by trial, but the IMPACT trial was started, I think it was announced, is it one and a half, two years ago? And it's, as Warren said in the presentation, we'll be able to, we actually have submitted the, or we, WashU, that Washington University that performs the trial, has submitted interim results to San Antonio. That's what you can expect around two years from start to interim results. Uh, so hopefully they will be presented at the San Antonio breast cancer conference. And in that case, we'll PR that as well. And, uh, the number of patients, uh, in that trial, I think it's said, uh, between 50 and a hundred it's, uh, we have an option. It's not fixed number, but it is in that range. And the others are pretty similar in terms of, um, size and timeline. Although, uh, as jail started this year and we PR that and patients are, are being enrolled and the better trial will start early next year. So give you, uh, some feeling for how we're progressing. Yeah. Um, And then there's a follow-on question. How much does the CDX collaboration negotiations depend on these trials? Does it depend highly? If it's okay, Henrik, I'll just answer and say no, it will not. I think the data that we've generated so far is what has been driving the... demand and the project portfolio that we have now with the 21 projects ongoing on the pharma area. So this is more targeted towards the US market getting into the reimbursement system and guidelines, proven clinical utility or strengthen our already proven clinical utility. So different purpose there. And yeah. In regards to those trials and Project Optimus, I guess you can spin a little bit. That's also a way that you can tell the interest from Project Optimus that the dose in question comes up in these discussions. So as Warren said, both the Yale and the better trial has a dosing component. And as you know, we have the PALBA dosing with Washington University. that was published or presented at least at the conference uh like a year ago or so so we are already into this area in terms of clinical trials um yeah see if i can continue reading um yeah uh europe uh are you you mentioned that you're a negation negotiations that in case that you'll be having agree another agreement uh signed this is a european question and yeah it's difficult of course to disclose when you're negotiating but yes we're working the same way in europe as we're doing with uh within uh us when we say that we our goal is in u.s to have 10 hospital agreements closed we of course already have a sales pipeline where we have progressed pretty far with enough of them so that we believe there's a great likelihood to meet that target. And it's the same thing with Europe. We have several ongoing discussions and negotiations which make us pretty confident that we'll meet that target as well. And it will be also on those markets that you are mentioning here, the bigger ones like Spain, Germany, UK or France. UK or France are a little bit more difficult markets when it comes to pricing and buy markers. So yes, we have looked at those as well, but we are prioritizing markets where we can get well-paid, reflecting the value of the product, and there's where the strongest demand and support is. So, yeah. So Hela will continue doing that as well. So thank you for all those questions. And there's actually additional, there's a lot of questions, appreciate that. Someone regarding the capital injection, can you give us a timetable? Yes, we can. We will publish the prospectus later today. The subscription period will start tomorrow. It will run until the 13th of December. And then for the warrants, they will be open to be able to convert during September. I don't know the dates, but September 24. And in the meantime, I understand they will also be tradable on the stock exchange until they are effective. Yes. Let's see if we have more here. The management is the management team. Participating in the clinical trial, yes, most of the management team members and also the board of directors members are participating. I think the details will be in the prospectus. I'm participating with 10 million. I know Lars is participating with a million and yeah, several other ones as well. So I'm very happy to see that. And you could say also that the biggest investment of all is done collectively by management in Sweden and the US team because they are indirectly participating by giving up some of their or all of their cash out bonus for this fiscal year. uh in order to uh to get a bigger stake in equity and so that's that's a huge commitment which i'm very grateful for and was a very important for my decision and i think yeah how we will implement the hospitals we have answered Can you expect similar revenue growth in next quarter? Yes, we expect this trend to continue and we see we expect to see effect of all those projects that we have agreed within a pharma services area and also the client bill contract that have we have received some few samples, but we expect us to receive a lot more now that we have that contract in place, so yes. Alright, here we have Marcus who is not happy with the share performance that has lost a lot of value over the last 10 years. Well, he's partly correct. I'm also not happy with. I'm very happy with the development of our company. I think the way we progress progressed. We have met the milestones from 510K clearance and onwards. I think it's a huge achievement on all three markets, really. The US milestones we talked about, the portfolio of pharma companies, the contracts we are making, agreeing on the European market, all those. I think is huge achievements by the team. I think we have not been rewarded as well. Marcus says that we have not have a share price development positive during the latest 10 years. That's not 100% correct. We had a great share price development until starting of 2022 when the uh, financial climate, uh, uh, changed quite significantly. And despite our progress with five 10 K clearance, we were more affected, I think, with those external factors. And the question, I guess, is what are we going to do about it? Yes. We are going to make sure that we become less dependent on the financial market and generate revenue enough to be cashflow positive. And this that's why we laid out this, this plan. which includes cost savings in order to get to that milestone with as little capital as possible as the price for capital is very expensive right now. So that's a short answer to that one. All right. I think we need to be a little bit selective here because we're running out of time.

Two identical questions.

Yeah, there's a lot of identical. The Scandinavian market, can you talk about the Scandinavian market opportunity? Yes. Would you want to elaborate, Helle? It's a market which has no reimbursement system, really, for diagnostics. But it's important to get into the guideline. We have strong support from key opinion leaders that we would like to benefit on. and the price levels are compared to European levels on the higher side. Isn't that a good summary?

Yes, and I think the commercial partnership that we're entering, we are very strong in Sweden with Key Opinion Leader Network, and this will broaden it to Denmark, Norway, and eventually also Finland and Iceland. It is a very strong agreement with a company rooted in Scandinavia.

All right. I think that has to be the last one. We're two minutes over time. I think I appreciate it was a lot of questions. Appreciate it a lot. Thank you for all the interest. And we have just closed a quarter, which we believe has been great progress for us. And we're looking forward to continue on that journey. Thank you very much for all the interest in our company. Thank you bye.