Hello everyone and welcome to the Biovica Q2 Interim Report. Today it will be me, Anders Rylander, and my CFO, Anders Morén, who will be presenting the report. The agenda for today is a short introduction of the company. We'll go through the highlights per area. Anders will do a financial update, and then we'll close with a summary, and we'll let in our analyst from Redeye, Filip Lindkvist, to ask some questions, and we will also open up from the chat. You can submit your questions, and then we'll be adding them with the answer to the presentation when we publish it tomorrow, so that will be the process this time, so to introduce Biovica, and especially our product DiviTum. DiviTum stands for dividing tumor, and we measure what's really essential within cancer, and that's the cell proliferation and the rate that the tumors proliferate.
Hence also the rate that the tumor and the disease grows, and it becomes an excellent measure of how aggressive the disease is, and also during monitoring, where you follow the patients over time, we have, or DiviTum having clinical trials shown an excellent ability to provide quick feedback if the treatment is efficient or not. This is currently done primarily with imaging technologies, and we have clinical trials provided that we can provide quicker feedback months ahead of imaging with a more convenient solution where it's enough to take a simple blood test that will then be analyzed with the DiviTum product, which is packaged as a kit and offered as a service, especially in the U.S., from our CLIA-certified lab.
This is of course very important, especially so for the patient to get quick feedback, to know that the treatment they're on are effective, and if not, the oncologist and the patient can make a decision and act on, for instance, changing dosing or switching therapy, so also important for healthcare providers as treatments are priced at more than $15,000 per patient a month within the breast cancer area, which is our first focus area, and of course you want to spend those money in an effective way, so this has been demonstrated in more than 30 peer-reviewed clinical trials where DiviTum has been used as a clinical biomarker, especially so for CDK4/6 response. CDK4/6 inhibitors is a type of treatment that are being used within breast cancer, and that's our key application to work complementary to those treatments.
These clinical trials have been performed by some of the leading oncologists and key opinion leaders in the world that works on and with academic institutions that also are world-leading and have a big impact. The results shown in these trials show a strong prognostic value and also that during monitoring of the disease can provide quick and precise feedback of the treatment efficiency. These results, of course, are very important. It's the foundation that we are building our commercial plan and also that has led to our 510(k) clearance in the U.S. by FDA and also the CE marking in Europe and Medicare inclusion in the U.S. This is the core of our commercialization efforts.
The market potential for this product, focusing only on the breast cancer area and on key markets, is counted in hundreds of millions of dollars in the metastatic area and in the earlier phases of breast cancer where we have early data presented about a year ago at the San Antonio Breast Cancer Symposium. It's about five times higher due to the larger number of patients that have been diagnosed with the disease. So the data comes from GLOBOCAN, which keeps track of the number of cancer patients, and this is the number of breast cancer patients within the metastatic and the early phases of breast cancer where these more aggressive CDK4/6 inhibitor treatments are being used. And the testing schedule comes from what we've established now on the market where you test monthly initially in the metastatic area and quarterly in the adjuvant area.
The assumption here, which is very important for the U.S. market, is around $400 per test, which is something that we actually are surpassing currently in the U.S. So it's a key assumption. On other markets, it's slightly lower, but in the same range. In that price range, we have a gross margin over 85%, and the go-to-market model is that we serve U.S., all 50 states plus Puerto Rico, actually, so it's 51, from our certified CLIA lab, and samples are shipped to our lab that serves the entire country. On other markets, we are using partners that we sell kits to, and then the partner offers the testing service.
When it comes to pharma companies, we also are selling our DiviTum test for use in developing new treatments where we typically sell both as a service for the majority of the time, but also to some markets where you're not allowed to export biological material. We sell kits to partners as well that analyze the test and perform the service. That was a very short introduction about Biovica and our product DiviTum. If we move into our quarter two report that covers the August to October for this year, if we start with the sales of SEK 5.2 million for Q1 and Q2 accumulated, which is an increase from last year's same period of about 30%, and in local currency, it's even more. One area that we have improved strongly is the cash flow, and it's a combination, of course, of increased revenue but primarily reduced costs.
During the period, we closed a combination of a rights issue and a directed issue of SEK 122 million , which of course provides us with a financial runway, and with that, then the developments that we expect to see within both U.S. and Pharma, where our ambition is to become cash flow positive during the calendar year of 2027. If we look at the U.S., one thing that I would like to highlight is the commercial agreement, which we signed with a large NCI/ NCCN center in the U.S. that opens up for increased revenues at this center, and the Pharma Services during this period, we have primarily signed several master services agreements and work orders and built up our services pipeline. Our revenues are similar to Q1, but coming quarters, we will see that we also are executing this pipeline with increased revenues.
Finally, worth mentioning is also two clinical studies that were presented at the biggest breast cancer conference in the world, which is the San Antonio Breast Cancer Symposium that took place in December here in 2025. I'll go through all these more in detail on the coming slides. So moving into the U.S., so even if we had an increase, if you compare the first two quarters this year with the first two quarters last year, our trend of growth over several quarters has between the first quarter and second quarter flattened out is actually slightly negative. This is something that we are not, it's less than our ambition and something we're working to address. It is partly explained that one of our top five customers, a large NCI/NCCN center, we completed a trial and it has been some lead time to convert them into clinical use.
And now we have signed a client bill contract and that will happen, but that has impacted our revenue and also has slowed down the growth. If we focus in on the U.S. market, we still are very confident and believe strongly that the strategy that we have chosen, the NCI center and IDNs that we target, is the right one and that we can accelerate and do more. And the other part of the market, the community oncologists, we believe that we can do better with a partner such as Tempus AI that has a larger sales force and also processes and tools to be able to target these customers that way. So we have several initiatives ongoing to drive growth further.
I talked about the client bill agreement that we signed, and also as we previously did a clinical trial with this client, we believe that's an excellent way to not only sign the agreement, but more importantly, make sure that we get traction after the agreement is signed. So we have several oncologists that support us that have worked with us, not only with this, but with several trials, and it's committed to implement this at this account. We also launched an LDT test, a laboratory-developed test that we can offer from our lab in San Diego to cover the application for early breast cancer when we monitor adjuvant treatments. Several customers have now announced that they will adopt it, and this will increase the usage. The most important one is our number one customer that will implement this starting January, and this will increase the revenues significantly.
The number of patients will be increased with a factor of fully implemented, which of course will take some time, but this is an opportunity where I think we can work with many of our customers also going forward. We also have done several improvements optimizing our processes, both when it comes to the sales process, when targeting our value proposition, and also when taking orders and delivering a result. This takes away a threshold also. Some customers have requirements to have an electronically supported process that we now have in place, and that also opens up for more use. So several improvements and some big ones with the client bill and the launch of early breast cancer. So it's a combination that I believe will drive growth again going forward for the coming quarters.
With that said, I think the biggest opportunity that will make a difference is the collaboration that we have with the healthcare giant, as we call it, with the revenues over $100 billion. It's a large IDN, meaning that this customer both have hospital services or healthcare services in combination with healthcare insurance services. That way, they can benefit from the significant financial or health economy businesses that DiviTum can provide, and we have a so-called client bill agreement with them since last year, and they are also one of our larger customers, but the big game changer for us, and I hope for them as well, is to implement this as step one as a clinical trial that for us will generate both revenues and important clinical data. This was something that we had aimed for to do during the fall of 2025.
And as we communicated on the previous earnings call, this has been delayed, and we had to go back and revisit and redesign the protocol slightly so that we now can start the trial during spring of 2026. So as positive, the new modified protocol has passed several important milestones internally within this large IDN. So we feel confident that the trial can start somewhat delayed, but still brings great potential for us both in terms of revenue, but also clinical data that can be used as reference and also for guidelines, inclusions going forward, etc. So another important partnership and agreement we signed last year in June was the collaborations with Tempus AI. Tempus is a diagnostic company that has a special angle, you could say. They're very, very strong in the data, and that's also with the addition in the name AI.
It's not only a hardware diagnostic company, it's just as much a software company that has a background from the tech industry. The founder comes from that. The status here is that we are planning together. We're preparing to launch DiviTum together with their project portfolio, and we're currently doing market research to develop our value proposition together. The ambition is to intensify this work during the first half of 2026 so that we can launch it on the second half of 2026. This is important for us because they add a capability where they are much stronger with their sales force of several hundred reps, and also the data they have that enables them to do very precise targeting on exactly the patients and oncologists that can benefit from DiviTum and the Tempus products that we will be bundling together.
So yeah, progress made here as well, although it is a delay from the initial plans. So long term, we have the same strong belief in this collaboration. Moving into the clinical results that were presented at San Antonio, the first example here is from Yale. Yale made a trial together with us using DiviTum, and the scope was to combine DiviTum with ctDNA as tests. And the outcome was that the two is an excellent combination when used for monitoring. Sorry, I'm mixing it there. The focus here was to ensure drug adherence, monitoring drug adherence, and that was primarily done with DiviTum.
But still, a very important value proposition for us because this is something that the pharma companies are very interested in, and to make sure that the patients are complying and taking the drug, and DiviTum could provide feedback quickly to make sure that that happened. And if not, that the oncologist can act on it. The second trial is the one I started to talk about. That's the trial that Mass General Brigham did, and they did that in collaboration with Harvard Medical School and Washington University. Washington University, we've done several trials within the past. And this trial is where we combined ctDNA profiles with TKa, and they turned out to be complementary. And that's, of course, very, very important as that aligns with the strategy that we have in order to complement ctDNA.
For instance, in the Tempus example, it's important for us to have this type of data. Also with universities that not only have a strong reputation, but also have a strong patient base. Mass General Brigham is one of the bigger companies in the U.S. in terms of patients that they are treating. In addition to these two, that we did an active collaboration with these two universities, DiviTum was part of five pharma posters that come from our Pharma Services business.
So this is very important for us, and this offers also an opportunity, as I mentioned, Pharma Services with this value proposition where we can make sure that patients are adhering to the drug, but also the opportunity to perform clinical trials with these types of NCI/NCCN centers that not only have a big impact, but also the ones that we are targeting with our sales force and also would like to sign client bill agreements with and to implement DiviTum on these centers. So very curious to see here what we can do going forward. Moving on to the Pharma Services. So during Q2, we have continued building our pipeline primarily with more master services agreements and work orders. The pipeline is now SEK 28 million for the coming three years.
This process of enrolling, especially the larger Tier 1 companies that have more than $10 billion in revenue, is a process that takes some time, but it also opens up a large potential because they have the resources to drive several projects and also do collaborations where you stratify patients and also create companion diagnostic products. That offers potential going forward. The trend is that we now have been able to enroll more of those Tier 1 companies and also that the projects are growing. I think that's a factor of two things. We are moving into later phases of so more phase I and also phase II trials where there are more patients involved. Going forward, the potential is even greater moving into phase III trials where the patient size is larger and also the potential to offer more advanced services is greater.
One very important thing is that DiviTum performs very well in this setting and that the customers are placing additional orders, and we can grow with the customer from preclinical to phase I, phase II, and also in several parallel projects. So with that said, we already know that the coming quarters, we will set new records when it comes to revenue with significant increases as we now have received the samples and are in the middle of testing those samples primarily in our San Diego lab in the U.S. So, good outlook going forward. So this was my introduction of the highlights in the different areas. Now I will hand over to Anders and ask you to go through the financials.
Okay. Thank you very much, Anders. Quick look at sales second quarter. That's the period of August to October. Sales was close to SEK 2.7 million.
That's a growth of 16% versus last year. Our U.S. IVD business, the U.S. Test business for clinical use, grew about 47%. What's called out as Research Use Only here is the pharma business that grew about 24%. And the research test business grew about close to 90%. You can see here also that the kit business, the yellow bar on these bars have reduced significantly. And that's coming back to what Anders said. The large pharma customers, they are preferring to send the samples to us, and we do the analysis rather than selling kits to them. We think that that's a great opportunity for us because we have a closer collaboration with them. Where we also see that they still buy kits is for the Chinese trials because there is a limitation of shipping human samples out of China.
We go into year-to-date second quarter, so that's the period May of October, almost 5.3 million, growth of 31%. Almost 60% growth in the US, about 75% in local currency. Pharma business, about 31%. Pharma Test business, about 66% growth, and whereas the kit is more or less flat. We didn't sell any IVD kits in Europe first quarter nor second quarter this financial year. Looking at cash and cash position at the end of the quarter, as Anders said earlier, it did a combination of rights and directed issue, about SEK 122 million . That's before the issuance cost and repayment of a bridging loan that we got. The transaction cost was SEK 8.9 million , so that's about 7% of the capital injected, which we think is a very good outcome. These transactions are quite expensive on the market, and I think we got a really good transaction cost here.
Cash position, SEK 100.6 million at the end of the reporting period, which, as Anders said, gives us a bit of a runway on cash. Looking at cash flow, that has also significantly improved versus second quarter last year. Improved about SEK 4.7 million versus for operating cash flow before working capital. And net operating cash flow after changing in working capital improved by 2.9. So all in all, about the negative cash flow, about SEK 18 million in the second quarter of 2025, 2026. So with that, I'll hand back to Anders for a summary and a Q&A session.
Thank you. All right. So to summarize it, to start with the U.S., as I said, the growth over several quarters has ended up in a flat development this, and we're doing a lot of efforts here to get back on the growth track.
We focus on the NCI and NCCN centers and the IDN. We just signed a client bill, and we have more in the pipeline. We will also work to implement DiviTum at these clients, and it helps that we have performed clinical trials at that site that I believe will accelerate also rollout. When we also are able to start the trial with the large IDN, that will be a big contribution also to revenues for the coming years. This effort, we hope, will both address the organic growth and with the partner from the IDN. If you look at the Pharma Services, we have momentum and progress here with more Tier 1 customers that we have enrolled. We have sold several larger projects and work orders. Revenues between Q1 and Q2 was also about the same, but we already know that the coming quarters will be a significant increase.
So Pharma is on track, you could say. The capital injection was successful, gives us a runway to achieve cash flow. As part of this quarter two report, the board of directors has decided not to give any revenue targets like we did before. We will get back to that when we have closed some of those agreements and have a more forecast of cash flow. But with the progress that we see both within U.S. and Pharma Services and the ability to close those and increase the revenues, we are aiming to become cash flow positive during the calendar year of 2027.
I see that time is moving fast, but a couple of ones from my end. So if we start with the U.S. health giant, do you still anticipate to participate with some resources in the study?
Yeah, that is something that we learn.
Of course, we have to learn from our challenges. So basically, the reason why we got the delay is that the path to starting a trial is quicker if you can be tagged as a sponsored trial. And with only a few resources that we sponsor, we will still make a significant profit, we believe. That opens up the ability for a smoother process so that we've learned and implemented in parallel with redesigning the protocol. So yeah, we still foresee a healthy revenue or healthy margin on that trial.
Understood. And what did you?
And first, we gave it a size. It is slightly different, but it's slightly less patients, but more frequent testing. So when we sum it up, it is in line with what we previously communicated.
And what do you expect when it comes to revenue recognition? Is it front-heavy, back-heavy, or evenly distributed?
For the trial? Yes. The enrollment is pretty linear. I mean, it will be a linear enrollment because they have pretty good understanding of new arrivals of metastatic breast cancer. This is going to be metastatic breast cancer. You can expect a three-year trial where you can enroll 50% of the total volume per year. Two years to enroll and two years to monitor, you could say.
Okay. If we move over to Tempus, the timeline has slipped to H2 2026 to develop a joint value proposition. This ambition from Tempus is positive as it shows commitment from their side. In the Q1 call, you mentioned the possibility of an early launch of a standalone DiviTum product to reduce complexity. Is this still an option, or do you instead go for a deeper integration?
No, I think—so the situation here is that we, of course, would have preferred a more aggressive plan, and we also have the capabilities to do that. At the same time, we have to respect their situation, and I appreciate that they have started doing the market research work and collecting information. So that's all good, and it's also a sign of their belief and see the potential in the test. However, Tempus had done several acquisitions, and they are resource-constrained, and I guess we have just to respect that and also appreciate that they now have given a plan, which I think we can deliver on both of us. So that's the situation.
Okay, fair.
And that's the short term. I think also for us, starting this trial with a large IDN is something that has a higher priority for us.
So if we can get that going, first half of next year and then second half, we initiate the Tempus and the community oncologists, which will be also long-term super potential with all the volume, but also it's not the same margin in that segment as with the IDN.
Yep. And despite removing your financial targets, you still have an ambition of achieving positive cash flow in 2027. Can you elaborate on this in light of the delayed partnerships and your expectations on OpEx going forward?
Yeah. So of course, we moved it forward. It's still within the same year, but later the same year, 2027. And that's due to we expect revenues to be pushed forward. At the same time, we have been able to manage costs better than expected also. So that's also a factor. So we have, yeah, that way we get a longer financial runway, basically.
So yeah, and we will continue to do that. However, we see that especially within Pharma Services, as we announced in the report, we have the ability already to our reps are selling far more than the cost they introduce. So it makes sense also to strengthen that area with more resources to, especially with the customer list that we have and the potential list in that area. So we'll look to add resources there. And of course, initially, we will also add cost and negative cash flow. So that will be a little increase. But in general, we are working hard also to do a lot with, yeah, small little resources and be effective in that way.
And the last question for me, as you mentioned, Pharma Services seems to progress well. But if we exclude Pharma Services for now, what are your expectations on the organic growth without the partnerships in the U.S. going forward?
Yeah. All right. So the Pharma Services, it's easier to forecast because we have agreements and we have samples coming in and we know that it will happen to a greater extent. It can still be delays, but we have fairly good position there. When it comes to the clinical sales, it's a little bit more difficult and we are also dependent on a few key customers. A lot of our revenues comes from NCI/ NCCN centers, and the ones that we have client bill. So if we have the situation with one customer that we have a delay before we can convert and use client bill from the trial, that is hurting us.
With that said, with the initiatives that we talked about, our goal is to go back to the type of growth that we had the last quarter before this one, where we were growing about 30% per quarter. So we will be working for doing that in the near future. In order to do so, I think the rollout of adjuvant for our largest customer, that will definitely, if we are successful there, I think that alone will help us to achieve that. And also if we can have a successful rollout for the client bill that we just signed, it's about the same size as our biggest customer. Currently, there's potential to grow there as well. And then we have a couple of other additional client bill in the pipeline lined up.
So if we can work hard in closing those and converting those to revenue and roll it out, I think there's a good possibility to get back to that growth that we had prior to this quarter.
Got it. That's all from me. Thank you.
Thank you, Filip. And we also be happy to answer all your questions in the chat. We'll put them at the end of the presentation that we'll publish tomorrow. And with that said, I guess, yeah, I'll finish with an image of our lab in the U.S., where I will be spending a lot of my time next year. And at the same time, of course, I'd like to wish you all a Merry Christmas and a Happy New Year when that happened in just a few weeks. Thank you.