Hello, and welcome to Biovica Q4 and full year presentation. My name is Anders Rylander, and I will be presenting together with CFO Anders Morén. Here is the agenda for the presentation. We will start with a short introduction to Biovica, the company, and the product. We will go through the Q4 highlights, and then Anders will do the financial update, and then we will finally do a summary and open up for a Q&A session. During the Q&A session, we will have Johanna Nier, our analyst from Redeye, to ask questions, but you could also, as a participant, submit questions using the form in the Teams application. If I should move into the Biovica introduction, I will start talking about our product, DiviTum. DiviTum is a tool for measuring cell proliferation from a simple blood sample.
We do that by measuring an enzyme which is closely related to the cell proliferation cycle. This has proven to have several advantages when monitoring treatments for cancer patients, as cancer grows through cell proliferation, and it correlates both to before start of treatment, how aggressive the disease is, but also it provides quick feedback if the treatment is efficient or not, or if the treating physician needs to take action, change dose, or change treatment. Currently, these patients are monitored by using different types of image diagnostics primarily. We offer a complementary tool that can more quickly provide feedback and also more convenient. This is, of course, very important, especially so for the patient, to get either a confirmation that she is on an effective treatment or can take action changing the treatment if it's not optimal.
It's also important, as we will talk about further down the presentation, for the healthcare providers, as it has cost impacts. The treatments are very costly, and of course, you want to spend these resources on the most effective treatments. This has been proven in many clinical trials. We have, up until now, 30 clinical trials that have been done in collaboration with some of the leading oncologists and institutions in the world, especially so in the breast cancer field, where we have the majority of studies and patients, but we also have proof of concept outside of the breast cancer area.
The evidence provided from these clinical trials that has been peer-reviewed and published in leading scientific journals shows that DiviTum has value both before start of treatment and during treatment and can be an indicator if the patient is responding to treatment or is progressing and action needs to be taken. I especially want to highlight the results that were announced in the San Antonio Breast Cancer Meeting in December last year, where we provided strong data within the metastatic area as well as some new data within the early breast cancer area, where we showed in two clinical trials that DiviTum also has great potential and value in the early phase of breast cancer monitoring, where the patient is being treated adjuvant for reducing the risk of recurrence of breast cancer.
This is a strong, solid foundation for the commercialization efforts for the product and has led to several important milestones, such as the FDA 510(k) clearance, opening up the U.S. market, as well as inclusion into Medicare and also creating the demand for the product. If we look at the market potential, our first application is breast cancer. The 510(k) clearance was focused on metastatic, so that's where we started, and that's where we have the majority of our revenues. We have our own CLIA certified lab in the U.S. from where we serve the U.S. market, and the market potential is based on the price assumptions, which also has turned out to be a good estimate in combination with the testing frequency and the number of patients living with the disease.
As I talked about, the new data from the adjuvant area or the early breast cancer area where patients are monitored for their adjuvant treatment opens up a significantly larger patient group and also, therefore, a larger market potential. The test itself is not so costly to produce, which yields a very attractive gross margin for the price levels that we have been able to achieve. We should zoom into the highlights from the fourth quarter that ended in April and also the events that have taken place after that. I'll start to summarize U.S., and then we'll dive into the details per area after this summary slide. During or slightly after the close of the fourth quarter, we announced a collaboration with Tempus, and that is a great opportunity for us to expand the commercial reach, adding the product to the salesforce of Tempus.
I'll get into the details about that collaboration, how it's structured. We also see that, especially now in the U.S., we have strong organic growth, and it's been stable now for the fourth quarter. It actually started the late third quarter, and I'll go into also what we see is the explanation and rationale for that. Also, our pharma services continue to grow. We see a trend of more and more tier one pharma now being customers, and we see also a trend that the contracts, the work orders become larger, and also that they are using this not only in one or two projects, but in several of their projects going on.
In Europe, a very important milestone for us was the agreement that we signed with Eurobio Scientific, covering several countries in Central Europe, which corresponds to about 60% of the European market that we, the way we've defined it, with the key markets. Together with the two previous agreements that we have, we now cover the key markets, what we are focusing on in Europe. We continue also to add to our clinical evidence and documentation. We have had two important conferences where we have presented data. First of all, the AACR, where we presented data on immunotherapy, and also on ASCO, when we have three different clinical trials being presented.
Especially the one at AACR is interesting because immunotherapy is a very promising area for the future, where we now have two patents filed within that area, which we will come back and report how we progress with those. Finally, the financial news that we had, we communicated financial targets based on now the partnership that we have established, as well as a rights issue, which is guaranteed to SEK 80 million, but could provide us with up to SEK 130 million of cash in order to realize the partnerships that we have and accelerate the growth of revenues that we have communicated in our financial goals. If I dive into the U.S., we have now been two years at the U.S. market, and I think we have some lessons learned which I would like to share and communicate. First of all, we have a lot of positives.
This is the first time we actually see the DiviTum in the clinical setting, and it's, of course, fundamental that it really works in that setting as well, not only in clinical trials. It's been surprisingly few issues with that, and the issues we've had is mostly to some logistics challenges, which we've been able to address pretty quickly with our logistic partners. It has been fantastic to see how stable the product is in this clinical setting. Of course, it's fundamental.
We also get very strong feedback on the value proposition that the DiviTum has, that there's a gap in the market currently, both in the metastatic area, where there are initiatives like the FDA Project Optimus to better monitor patients on treatment and also being able to optimize dosing, hence the name, as well as the early breast cancer setting and the need for finding better biomarkers for monitoring of adjuvant treatments in this area. One other very important thing that I would like to point out is that the assumptions that are presented on the previous slide with the average price, that this fundamental assumption for the market potential is the $400 from the U.S. market. The two years in, we can see that this assumption holds well. We are able to actually, in the agreements that we signed with our private commercial partners, go significantly above that.
Those agreements is almost, yeah, 80% above the $400 mark. And with Medicare, we are paid $322, and also Medicare pays regularly and within 30 days, so very good there. Another thing that I'd like to highlight is that we have been able to reach out to the top oncology centers in the U.S., the NCI and NCCN centers. That's where we have the majority now of our revenues, and we've been successful, and it also provides some strong reference cases for others. We're able to use those oncologists to participate and share advisory boards, sharing their experience and success with DiviTum to other oncologists. It's also been a great way of attracting new customers. A new area, especially so after the adjuvant data presented in December last year, is the IDNs. IDN stands for Integrated Delivery Networks.
Those are a combination of healthcare providers that at the same time are health insurance providers, so they can benefit from making smart treatment decisions with DiviTum and then also harvest the economic benefits of doing that in their insurance leg. We can provide a very, very attractive health economic business case for these companies. We signed an agreement with one of the larger of those customers or of those players on the U.S. market in December, which we communicated, and I have an update on how that work is progressing. We also seen some challenges. Our sales development has been slower than expected, both from these categories where we have received very good feedback, the NCI centers and the IDNs.
Our conclusion is that although the value proposition for DiviTum is appealing and we have a strong foundation of clinical data, oncologists want to see for themselves and then typically start using it selectively on a few patients, often the most complicated cases. Now we see that more and more we see growth with the existing oncologists as they have now been convincing it in real life and are now using it more and more on their existing patients as well as recommending it to their colleagues. Great progress there. Another area where we realized that we need more scale volume in order to effectively reach out is the community oncologists, where we communicated a year ago that we are looking for a partner to be able to address that.
During May, we communicated the agreement with Tempus, which is an example of such an agreement, which we believe strongly in that will address this shortcoming in our go-to-market model and being able to scale also in this segment. If you summarize it, we have a lot of positives. We have some challenges, and I think we've been able to address it by the Tempus agreement, by finding the partners within the IDN area and building on the NCI centers. We are well positioned for growth going forward in all these areas. If I should break it down a little bit, how we see the market is structured, we have the NCI centers in the middle together with the IDNs and the payers. Those three are the core area which we will address with our Biovica organization. The payers go across the board.
A Medicare patient could be either at an IDN or an NCI center or a community oncologist, same thing with the private insurance company. It depends on how the patient is insured. Working with the payers will benefit us in all three of these categories. The community oncologist, that's where the majority of patients are being treated. That's also where we now have signed the agreement with Tempus, where we will be able to get a totally different scale in reaching out to these customers. Looking at our sales, we can see that after a couple of quarters with slow growth, we've seen basically since the start of the year after the San Antonio Conference, we've seen that every month is a new best month. If you compare it with a year ago, it's about 120% increase.
If you compare it to the previous quarter, it's an increase of about 30%. This trend continues also in May. We think, although it's early to draw too many conclusions, we still see a strong trend. When we are reaching out to our customer, trying to understand what's driving this, we see a couple of drivers for this growth. In general, the San Antonio results with the strong data, both within the metastatic area as well as the new data, which were very strong also in the early breast cancer area for adjuvant monitoring, has helped a lot to build confidence in the test.
We see also on the existing customers, many of them have now been following patients for many months and have a lot of success cases and are now expanding both to a majority of their patients as well as recommending it to their colleagues. We have our sales reps reaching out to new customers. We have been able also to enroll a couple of new institutions also in the New York area, which we are able to do since we have extended our CLIA license to cover New York as well. With that, we are covering all the 50 states in the U.S.. Positive momentum in the U.S. business. I think we have a great opportunity to accelerate that further a lot with the agreement that we signed in December with what we call the healthcare giant with revenues over $100 billion.
We signed a client bill agreement, and they have started using it in the metastatic breast cancer area. We are now, as we've also been communicating earlier, talking about a clinical trial with the intention to introduce this as the standard of care for their early breast cancer adjuvant treatment. The status here is that we have developed a protocol that we have agreed upon, and the next step is to submit it to the IRB. We believe that we have a very high likelihood of getting that approved so that the trial can start in December this year so we can start enrolling patients that way. We will be paid for this trial in line with the agreement that we've signed. This has the potential to be the largest contributor to reaching those revenue goals that we've communicated earlier last month.
This is how the trial is structured. We have a majority of their current patients that they will split into two arms, one with their current standard of care practice, and then they will compare that with using DiviTum to stratify patients into two arms and then monitor how they are responding to the adjuvant treatment. If they need to have a more aggressive and powerful treatment, they will then be moved to the arm where you have the CDK4/6 inhibitor. In this way, the patients can get an optimal treatment as well as avoiding unnecessary side effects, as well as costs are managed and resources are used in the best possible way. We also signed an agreement with a company called Tempus AI. Tempus, I think, is interesting for many, many ways.
It's a diagnostic company, but it comes from the founder has a background within the tech industry and IT, hence the name Tempus AI. It's based on the large database that they are building out based on the diagnostic data that they're generating. The company is listed on NASDAQ since June last year, has a market cap of $12 billion. From 2024, they have $700 million in revenues. They've been able to grow that very impressively, 30% compared to last year. I guess it's thanks to a large and efficient sales force. They haven't given a detailed number officially, but we know that they have hundreds of reps and their focus is within oncology.
The way the agreement is structured is that DiviTum will be part of the oncology portfolio panel that will be sold and promoted through the Tempus, both sales reps and their channels. They also have IT support, their web page and integration with electronic record systems so that they can reach out to patients and oncologists and also do some targeting. Both strong sales organization and strong sales processes supported by IT. The actual analysis will be done by Biovica in our San Diego lab. We will also be responsible for claiming the reimbursement of the test. This means that we will have the upside if we can improve the current level of reimbursement by entering more agreements, for instance, with private payers. This improved margin will be to Biovica's advantage.
We have talked with Tempus and also discussed what we can expect together in this collaboration. What they have estimated is that about 20% of their current customer base, which is growing from 30%, as we said, is an ambitious but reachable target to be reached two years after launch. This agreement is also expected to be a significant contributor to the financial goals that we have communicated for U.S. revenues. If we look into the pharma services area, we have also some lessons learned there. We have a lot of positives here. We see that in these clinical trials, when pharma are using DiviTum to develop new therapies or new indications for existing therapies, DiviTum works great and has a significant value. We have more than 20 pharma companies that are using DiviTum for this purpose.
We see also that a lot of the customers, more than 70%, are repeat customers that are placing more than one orders. Especially the tier ones, the ones that have more than $10 billion in revenue, are repeat customers using it for more than one project. The bigger companies have several projects ongoing and see the value to use it more widely, which, of course, drives revenue for us. We also see some challenges in this area, especially the tier one companies that have a long enrollment process. We have now five of those customers. We have actually been able to go through an enrollment process for the sixth one. Soon, we will have a sixth customer. This has taken some time, and it has been a learning experience for us as well.
You need to have a lot of assets in place to be able to fulfill their high demands on their suppliers, which we now do. We are able to scale this up, which is very positive. One thing that we also have learned, especially with the smaller pharmacies, is that plans can change quickly. If we do not have that built into our business model, it will hurt our revenues. We have developed our business models, and now we have protected ourselves. We have more upfront payments, and we share the risk to a greater extent. That has led to the orders placed. We also can rely more on the volumes that it will really happen. It has improved the accuracy and precision in our forecasting. To summarize it, we have improved our business model.
That means, as I said, better, stronger commitment from our customers and better precision in our forecasting. We also have put assets in place to be able to more quickly enroll and scale up, especially the big customers. Also, having these revenues with high likelihood is an important part of our financial goals for the coming two years. The current status, during and after the fourth quarter, is that we initiated six new projects, work orders that make up a pipeline of about SEK 25 million. The way this works is typically a clinical trial in this area is one and a half to two and a half years, and the revenue will be booked over that period of time where the analyses are taking place. We also have onboarded two new tier ones, so we have a total of five.
Yeah, we expect more to come. As I said, we have passed the enrollment process for yet another one. We are about to sign another deal there as well. We have seen interest increasing after also AACR, ASCO, and San Antonio. The clinical data that we were able to present is something that drives revenue here as well. We are also seeing that when we are especially targeting more and more of the larger customers, the tier ones, the project size also tends to increase. Previously, our projects were around SEK 500,000 to SEK 1 million. Now we have several projects that we have announced that are SEK 7 million. I think there is a potential here also to increase that significantly when we move into the next step where we do more tighter collaborations.
We are using DiviTum not only as an experimental biomarker but also working into the protocol and also using for patient stratification and for monitoring and CDX collaborations. I think the likelihood for that also increases where you have more tier ones in your portfolio. Last is Europe. If we do some lessons learned from Europe, we've seen that there's a spillover effect. The milestones that we've been able to take in the U.S. and with pharma have a positive effect in Europe. We've been able to attract partners of higher quality with greater potential that we believe have a strong probability of success and are also very committed to go to the market.
We also have been able to, when it comes to our price assumptions on the European market, we see that we have been able to agree on the levels that we have used for our market potential estimates. We have also seen some challenges here. I think one that we have learned from the initial partners that we were able to attract is that they did not have enough resources or quality. Now we have been able to replace them with three that we really, really have strong faith and believe in. That is progress. The new partners that we have have set lower expectations when it comes to the timeline, but I think with higher precision. We think Europe is interesting a few years in. The potential is great, but it will take a couple of years because you need to get into guidelines.
You need to establish partnerships with labs, etc., per market. That is why you're also depending on having a partner strategy. That is why we're also very happy with the partners we've been able now to agree with. We're also, yeah, so looking forward to work with them going forward here as well. We have also discussed with several of the breast cancer groups on how to get included into guidelines on different markets. This all boils down to us looking into the financials and are now giving guidance on what we expect in terms of revenues for the coming two fiscal years. For the fiscal year that started 1st of May, we expect to be able to have revenues of SEK 50 million, where the majority will come from the U.S. market.
The year after, our goal is to achieve SEK 150 million in revenues, still with the U.S. being the largest market. Those SEK 35 million plus SEK 100 million, SEK 135 million, if you split it down, the majority of this is from the collaboration that we have with the healthcare giant, the IDN, where we have the study protocol that will drive about 50% of that volume. There is potential to expand into other areas, other IDNs, and it will be a strong reference case that has not been included, however, in the estimates for these two fiscal years, but it is potential for the future. The next biggest contributor is the agreement with Tempus, where we expect about 30% of the U.S. volume for the two coming years to come from that source. It is a non-exclusive agreement.
Although Tempus has a significant market share, it's still open to expand with other agreements into other areas of the market with other partners. That's also a potential for the future. The last area is the organic growth on the existing accounts, which we expect is going to be about 15% of the volume in the U.S. With that said, I'll hand it over to Anders. Anders will go through a little bit more in detail our financials for Q4 and also the rights issue that we have announced that will take place later this summer. We'll just switch seat , Anders, please.
Okay. Thank you, Anders. See if I can get the technicalities to work. Year to date, sales ended up at SEK 8.6 million versus SEK 7.3 million last year. That's about 20% growth compared to last year.
If we start digging into where this growth is coming from, you can see here that IVD test, that's the U.S. sales. That's the majority of the growth driver, a little bit more than SEK 2 million. IVD kits, we have started to see a little bit of sales in Europe. We will see a little bit of sales this fiscal year also, but we think that that will take a little bit more time, as Anders said, about getting reimbursement, getting lab agreements in place, and so on. We see a slight increase in research test or pharma service test. However, that is balanced off by a negative impact on the kit sales in the pharma business. As I've said earlier, that was a big number of kits sold to a clinical trial back in Q2 last year that were then that trial was finished.
We have not seen that sales. However, we see a sort of an increase in interest of performing clinical trials in China. We know that China is not very keen on exporting human samples outside of China. We know that we will sell kits into China for clinical trials. That is a general trend that there are more and more trials being performed in China in general. If we dive into the U.S. sales, we ended up at almost SEK 3 million. That is about 275% growth in absolute numbers or Swedish kronor. If you look at constant foreign exchange rates, U.S. dollars, it is a little bit more. Actually, it is about 280%, a little bit more than that even, since the dollar has weakened quite significantly in the last quarter of our fiscal year.
We think that that is coming from you saw that slight increase or quite significant increase in the U.S. sales in Q4, driven by the SABS data that we announced on adjuvant data. Cash flow, very quickly, SEK -18 million operating cash flow before changing working capital. That is an improvement of SEK 2 million overall, basically the same as Q3. Net operating cash flow compared to Q4 last year has improved by SEK 8.5 million because we had a significantly higher cost base at that time. We did that reorganization in April last year. A few words around the rights issue. It is fully guaranteed at SEK 80 million. That gives an opportunity for us to leverage recently signed partnership agreements that Anders has walked you through. The structure is that the rights issue is on SEK 80 million.
Then on top of that, if the rights issue is fully subscribed, there will be a direct issue to the top underwriters of another SEK 52.5 million. All in all, the maximum proceeds could be SEK 132.5 million. You see here that the guarantees of SEK 80 million, that is top underwriters of SEK 52.5 million. You have subscription commitments from existing shareholders, about SEK 17 million. Then we have a small part of bottom underwriters. It is only SEK 10.9 million that have the standard bottom guarantee or bottom underwriter. We are really, really happy about this structure. As I said, the way it works is that the top underwriters, they are guaranteeing their SEK 52.5 million, but they are also guaranteed to get their SEK 52.5 million.
If we get a fully subscribed rights issue, there will be a direct issue to the top underwriter of SEK 52.5 million. The SEK 80 million plus the SEK 52.5 million becomes SEK 132.5 million. That is the maximum outcome of this. You see the process on the right side of the slide. We will have an extra general meeting on the 14th to approve this. We will have the Section 9 disclosure document published on the 17th of July, subscription period, last two weeks of July, and then the preliminary outcome, first week of August is the plan. You can also split these sort of guarantees or underwriters into two different categories. We like to talk about anchor investors. That is the top and subscription commitment underwriters.
The largest one there is a Dutch family office that is going in with SEK 40 million. They have been a shareholder since 2024 when we did the direct issue where they participated. They have also signaled that they have a desire to be represented in the board of directors in the future. Anders, our CEO, is adding another SEK 10 million. Both these investments in SEK 40 million and SEK 10 million is a combination of subscription commitment and top underwriting. We have another section of Swedish investors and existing shareholders that is adding SEK 19.1 million. It is the same SEK 80 million, but it is just structured or cut a little bit differently so you understand who is putting in how much money in total in both in terms of top and subscription commitments. Bottom underwriters, only SEK 10.9 million. We are really, really happy about this structure.
Use of proceeds, about 40% being used for commercialization in the U.S., 25% on service development within pharma, only 5% in Europe because we think that that is more for the future. And product, and we also, as Anders said, we have quite interesting data on outside of metastatic breast cancer and CDK inhibition. So we'll use a little bit of that to continue to develop our product and also scale up our production capacity to meet the demand that we are expecting. And then, of course, some regulatory requirements coming on top of that. With that, I think I'll hand it back to Anders for a summary and then a Q&A session after this. Thank you.
Thank you, Anders. Very good. I just have one summary slide, and we'll go into the Q&A session.
Over the seven years, we've been able to make some key milestones, key achievements that have laid the foundation for our commercial journey with DiviTum. I think also with the latest addition here, the agreements both in the U.S. with Tempus and the large healthcare giant, plus the European agreements and also the development in pharma, we have put ourselves in a position to be able to scale up these initial revenues that we currently have. We have actually some upcoming milestones. One thing is to formalize the adjuvant breast cancer monitoring offering. That will be done as a complementary test that we can offer from our CLIA lab. We will be able to use our current PLA code to get reimbursement from Medicare. This is for extending the regulatory label.
We also are looking to close that protocol for the clinical trial, get it through IRB, start enrolling patients with the ambition to establish DiviTum as a standard of care for the healthcare giant we talked about. We signed a frame agreement with them in December. We will later this year do a submission for NCCN guidelines and look forward to the feedback there. We are continuing to work with our pharma partners to extend revenues, also closer collaborations and leading to new projects and products. I think in addition to these milestones, I think the focus now will be to work with the partners that we have signed agreements with in order to drive sales together with them, as well as targeting the customers that we have both on the U.S. market and within the pharma services area.
I think also I would like to thank also especially the anchor investors taking part in the upcoming rights issue and for the confidence that they show me and the team. This will enable us to leverage all the achievements we've made so far, the agreements we've put in place in order to scale up the revenue and create value both for patients that get better and quicker feedback on how they are doing with their cancer treatment and together with the treating physician being able to act on that, as well as the value we can create for healthcare providers and payers, making best possible use of the resources that are being spent within this area. In the end, also to create value for our shareholders investing and supporting Biovica. Thank you very much for taking part in this. I will now open up for questions.
I think the first one we have here is Johanna Nier. See if you can unmute yourself, Johanna. I'm happy to get with Anders to take your questions.
Great. Can you hear me?
Hear you well. Very good.
Excellent. Some questions then from our side. Of course, you pointed to a significant market opportunity for quite some time. You added partners in both, especially pharma and increasingly so on the U.S. and European clinical side. As of late, you also added partners with potentially specific sales forces and sales cloud. It would be very interesting to hear what your visibility is and activities is on, especially Tempus and the large IDN partner currently and over the coming quarters, the rest of 2025 basically.
Yeah. That's why I broke it down into three areas for the U.S..
If you start with the organic growth, you see that already, and we expect that to continue. As we will be able to refocus our resources, we can put more resources in the areas that we want to focus, and we can leave other areas to our partners like Tempus. I think the organic growth will benefit from that as well. When it comes to the Tempus agreement specifically, we signed the agreement in late May, and we're now in discussion with them on how to start up the, yeah, we're in the initiation phase, you could say, where we are training their sales reps. We are establishing integration solutions so we can handle large volumes that they will submit and also integration to their system so that they effectively can include our product in their portfolio.
The timeline is that we are doing it right now, and we will require a couple of months before we will see that we will start generating revenues from this. Basically late summer. When it comes to the healthcare giant, the big IDN, we have estimated that during September, we will be able to get the IRB approval so that we can start enrolling patients, or we, it is them. We already have initiated some logistics there as well. We have set up processes for collecting blood samples, sending it to the lab. They are starting using it for the metastatic area, a few oncologists, and we have planned training of oncologists also to spread the words and get it out.
There is an upcoming milestone which we will publish both when we submit to the IRB and also when the IRB approves so you can follow how this important project develops. Hope that answers your questions, Johan.
Yeah, very useful. What about the IRB? When can that be sort of cleared?
Yeah. This big company has their own, it's part of their own organization, so they have a dedicated IRB. I think they have a good understanding of how the process works. That also is a very well-worked-through protocol where there's a great demand, not only within this company, but in general on the market. With that said, our estimate is that there's a very high likelihood for a quick process to get this approved within a couple of months. That's why we say September for start of enrolling patients after approval.
Okay. In summary then, we should expect some sales contribution, perhaps already late Q1 from these, especially Tempus, and then more so Q2 and later in 2025, 2026.
We expect our organic growth to be seen in the coming quarters. On top of that, we will see especially the impact from the IDN, the clinical trial, to start happening, yeah, from, let's say, if we start next September, so from October and onwards, because they have a strict protocol. They will start enrolling patients. We think that will be quicker and therefore also the biggest contribution going forward.
Yeah. A slightly technical question then. You mentioned that you will handle the reimbursement, I think, regarding Tempus. What about the sales recognition?
You mean when we can book the sales?
Yeah.
That will follow our ordinary process.
We are currently recognizing our sales when we report back the results. Typically, our lab has a very quick turnaround time. If we receive the sample and documentation that comes with the sample, we are able to turn it around most often within 24 hours and report back. In the U.S. lab, we have already now established very efficient processes supported with IT, so we could easily scale for bigger volume and do the reporting and then do the reimbursement. What we do is we report on an expect number, so how much we expect to be paid for that sample. When we now, after two years' experience, we can see that our people handling the revenue cycle process, which it is called, have a very, very high precision in estimating what we then later receive as payment a little bit later.
Typically for the Medicare payments, we get paid from Medicare in less than 30 days. They are very good when it comes to payment. When it comes to the private payers, it varies a little bit more, but most of them, a high portion of the volume is from our client bill contracts. The payment term is regulated, and they pay according to those terms, typically 30 or 60 days. If it is 60 days, we typically are compensated price-wise for that. That is how it works. The last category is the private payers. It varies a lot. The good news there is that we have not received any rejection from medical necessity that they do not support the claim. Payment, both price and payment time, can vary a bit.
I think we are doing better than expected in that area as well. That is the one that we can improve the most over time. With greater volume, we have the opportunity to have agreements with the largest payer, and then it will be similar to a client bill contract.
Yeah. Very useful. What about on the pharma side? You have some work order, you added partners, and is it, but sometimes the actual sales can come a bit later and yeah.
Pharma, I think that's why also we have some lessons learned there as well. The general trend is very strong, and those numbers that we have presented there, especially for this fiscal year, we have a very, very strong belief that we can meet those.
There is the one with the less risk, I would say, because we have agreed we have agreements for almost the entire service volume. As Anders said, we know that on top of that, there will be kit sales because of when, especially the tier one pharmas, they will have to buy kits for the Chinese. They do studies in China. In China, you need to have kits because you cannot bring out biological samples out of China. We are confident, and we have also had some lessons learned. We are more efficient now, and we are able to mitigate some issues that we have seen with delays and reduced volumes, etc., already in the contracting phase. That is why we are more confident also being able to meet those numbers.
Thanks. That is useful.
What about, of course, you will need to support your partners and you guided for OpEx around SEK 90 million per year. Is there a risk that you will need to add more supporting resources?
I think that's something that's good that you point that out because I think I forgot that on the financial guidance slide. It's not only the revenues that we're giving guidance, it's the cash flow for especially this fiscal year where we think we have the organization in place that we need and we don't foresee any large increase. So far, I think managing cost, we have been very strong and have a history of being able to do that well. I'm pretty confident that we will be able to do that going forward.
When we see the revenues increase, I think there are areas where we can then add resources to further accelerate sales, both within the U.S. organization and the pharma services. We will be looking into doing that as soon as we can see a positive trend in revenues. With that said, our goal is to become break-even in the third quarter of fiscal year 2026-2027. That would be January 2027 for break-even.
Great. Finally, from our side, based on your outlook guide, which is reasonably specific, you do not seem to expect that much from Europe despite having gone through your partners and replaced some and added some.
That is a good comment. For next year, we only estimated SEK 1 million. I think we already are in discussion from our Spanish partner. We have deals coming in. I think we have identified revenues.
We have revenues from Italy. We are in discussion also on the Swedish market on how to get into guidelines, etc. There is progress in Europe as well. I think we have learned the hard way. The targets that our first partner committed to, that we added continuously and then communicated, they were not close to meet. We have stepped up several steps when it comes to partnerships on the European side. We think that this is something that will be developed over time. There is a longer go-to-market process in Europe. That is why when we communicate these two-year financial goals, it will only be SEK 10 million year two that impacts that.
Interesting. In terms of reaching break-even, it will be the U.S. side and especially the IDN side. Secondly, the pharma and, well, Europe will take more time.
Yeah. Also, now that we have these agreements in place, we are spending very little of the resources, as Anders pointed out, on Europe. I think it was only 5% of the use of proceeds to train and to manage and to support them. We put the majority of our resources where there is shorter time to market and greater potential short term. That is how we think because the price of capital is currently very high right now. We need to use it wisely and invest, put it where we get the most leverage. Hence, we have downprioritized Europe. We are also working with partners that will be able to drive the work there outside of our organization.
Perhaps adding, what about pipelines and additional partners? Some of these partnerships are non-exclusive. Are you still sort of having the ambition to add U.S. partners? Can you support additional partners?
Yeah. Our ambition when it comes to the U.S. market, we have, you could call it an unquantified upside in this plan for the two coming years that we will see a large impact from revenues from additional partners, both other diagnostic companies with a sales rep like Tempus or like the IDNs. Especially on the IDN side, there are a lot of options. We already have ongoing discussions on several of the IDNs in our customer list. Our ambition is to add additional IDNs. I think the first agreement that we have is a great reference. When estimating revenues, we have had very low expectations from additional ones for these two years. We believe that in the future, we can add several IDNs. There is no real competition there. The same way when it comes to Tempus, they have competitors.
I guess there's a maximum on how many competing partners that you can have before it becomes too dense, sort of. I think another opportunity with Tempus is to move into a closer collaboration. We will explore that as well. They have also significant business within their pharma services. I think with the customer list that we have now and the ongoing projects, that will be attractive for them as well. We will also continue working, see if there's additional value to be explored. There's a lot of potential in the milestones that we have achieved. I think we should spend the majority of our efforts with our existing collaborations and customers because there's a lot of unexplored potential. It's also the quickest way to get revenues before spreading into new areas.
Y eah. Thanks. A follow-up there, which I should probably know.
Let's say you get or your IDN partner gets the clearance in September. Will other IDN partners' future benefit from this clearance, or will they need to follow the same route?
It's a little bit open for discussion. I think the ambition that this first one has is to really establish, yeah, guideline change so that they have a high ambition. They want to do a real solid clinical trial that can be a game-changer, the way you treat patients in the adjuvant setting. That is, of course, also interesting for us because we will benefit from that as well. I'm not so sure that other IDN players have the same high level of ambition. It could be also less demands on such an ambitious clinical trials and thereby also shorter time to market in the adjuvant setting.
In the metastatic setting, I think it's not as a strong health economic business case, to be honest, but the threshold is also lower. You can start using it right away with the data that is available currently.
Excellent. Thank you.
Thank you very much. Thank you all. We're a couple of minutes over time, but thank you for attending and listening. I wish you all a great upcoming midsummer. Thank you, Biovica. Bye-bye.