Biovica International AB (publ)

Hello and welcome to this live queue with Bivika. First off, we will have a presentation from Bivika and from Thijs Kipling and Anders Morén. And after that, we will have a Q&A session. And please feel free to send in your questions through our web page. So please, Bivika, go ahead and do your presentation.

Thank you very much. So. Good morning here from San Diego in the U.S. and welcome to BioVica's Q1 2026-2027 earnings poll. My name is Tijs Kipling. I'm the CEO of BioVica and I'm joined today by our CFO Anders Modén. Before we get into the results, slide two contains our standard forward-looking statements disclaimer and I'd encourage you to read it at your convenience. Today's presenters are, beyond myself, also our CFO, Anders Morén, who will take part in the Q&A session later in the presentation. We will begin with a brief introduction to BioVica, followed by our Q1 highlights, a financial update, and then we close with a few summary remarks before opening the call for Q&A. We welcome you, as mentioned, to submit written questions through the chat. These will be answered in writing and appended to the end of the presentation, which will be published on Biobica. And joining us today, as mentioned, is the analyst Fredrik Tord from Redeye. In the next few slides, I'd like to introduce Biobica and highlight several aspects of the company that I believe make for a particularly compelling investment case. STIVITUM TKA is our FDA 510K cleared blood test that monitors and predicts treatment response in hormone receptor-positive metastatic breast cancer, providing clinical insight as much as 83 days before imaging. Viobica is listed on Nasdaq First North, headquartered in Uppsala, Sweden, with our CLIA and CAP accredited laboratory in San Diego, California, serving all 50 states here in the US. I'd like to highlight what I see as the core of our investment case. First, the dividend platform itself, a quantitative proliferation signal from a single blood draw, giving oncologists information before imaging confirms what biology is already showing. Second, that 83-day lead time is validated against standard imaging, and we are seeing real patient cases where it flags response and resistance. And third, we build the commercial infrastructure to act on this. Our clear and capacitive lab has processed more than 900 tests over the past 12 months across 32 active accounts with a 75% prior year retention. Behind all of this sits a strong and expanding evidence base. More than 30 publications across 5000 plus patients and six cancer types with our FDA 510 clearance giving us credibility with both physicians and with payers. Our lab model is centralized with a cross margin structure above 85%, so revenues would scale faster than our fixed cost base. And we do see multiple paths for upsides. Our hormone receptor positive metastatic breast cancer beachhead expansion into early breast cancer, a patient pool roughly five times larger, and beyond that, our pharma services and CDX collaborations. Let me turn to the commercial traction we're seeing in our US lab and services business. We have now 46 accounts to date, including recurrent use by major academic and community oncology networks, and repeat ordering across these leading institutions signals real workflow integration and not one-off sampling. Test volumes have grown for nine quarters straight, up 63% since fiscal year of 2024 and 2025, and that momentum is accelerating into this fiscal year. Looking at the underlying ordering behavior, 75% of our active accounts ordered more than once. 75% also of our providers sent samples multiple times. We retained 81 percent of accounts from prior year and 26 out of 36 active accounts ordered in three or more months. Taken together, this is what gives me confidence in the durability of demand over here in the US. Looking ahead, we're targeting study activation this fiscal year. with a large integrated delivery network partnership, which we expect to open a pathway to NCZN guideline inclusion and to further accelerate volume growth beyond what we are already seeing. As mentioned earlier, hormone receptor positive metastatic breast cancer remains our beachhead. Based on roughly 100,000 US patients, we have estimated this opportunity of approximately north of 400 million US dollar in available market. This is our immediate focus, and it's where we intend to win through clinical adoption, continued evidence generation, publications, and over time, guideline inclusion. At the same time, we are working closely with the research community to build evidence in early breast cancer patient pool with clinical trials for this indication starting in Q4 of this year, which has the potential to expand our addressable market. Beyond that, we see a longer term platform opportunity across multiple indications, including lung, GI, blood cancers from 2028 and onward. supported by our granted ICI biomarker pattern and algorithm IP that is currently in progress. Let me now turn to our pharma business, which remains a key source of revenue and platform optionality. We see the total addressable pharma opportunity here at approximately US$8 billion by 2030, with the US representing more than 40% of that. We see three distinct revenue opportunities. First, services and kit sales linked to drug development programs, typically US$50,000 to US$400,000 per project, which is where our pharma revenue is generated today. We currently have 24 ongoing collaborations spanning across CDK46, PIK3, SIRTS, and other oncology programs representing approximately 30 million Swedish kronor in ongoing contract value. Second is companion diagnostic collaborations worth roughly between 5 million US to 50 million US per development program. Several of our current engagement They have CDX potential, and those discussions are also ongoing, although we do not have any signed CDX contracts or either any CDX revenue as of today. Third is CDX product sales worth more than $50 million per year for approved product, which obviously represents the longer term highest value opportunity. However, there are no CDX products on the market for us today, but this is where we expect to be over time. Looking at our current work orders, of our partners are Tier 1 companies with more than US$10 billion in annual revenue. One is Tier 2 and 12 in Tier 3. By drug class, CDK4-6 inhibitors remain our largest focus at 15 programs, followed by SIRT at 4, IO programs at 3, PIK3 at 2, which reflects where the market is today and also where we are beginning now to diversify. My full quarter as CEO has been about decisive action, cost discipline, a strengthened leadership team, and accelerating momentum in our pharma services business. On the pharma side, pharma services revenue nearly doubled year over year, up 95%, with pharma test services revenue growing 187% on growing demand for pharmacodynamic biomarkers. We also made some difficult but necessary decisions on costs. We have streamlined the organization, which carried a near-term cost in the P&L, but sharpens our cost base going forward. And we ended our agreement with Tempus AI so that we can focus our US commercial resources more directly. Finally, on leadership, I'm happy to say that Maria Ekdal will be joining us as CFO, and our nomination committee has proposed a renewed board ahead of the 2026 AGM coming up next week. Together, I believe that these changes, they leave us as a leaner, more focused BioVica heading into the rest of the year. Let me now turn the focus to the Q1 highlights. Net sales were 4 million Swedish kronor, up 56% year-over-year, or 57% in local currency, driven primarily by pharma services. Operating cash flow was in Swedish kronor minus 16, which is a modest improvement versus last year's minus 17. And our cash position stood at 51.6 million Swedish kronor, up from 16.3 million the prior year. On the US side, IVD test revenues were, in Swedish kronor, 1,084,000 kronor, up 1% year-over-year, or 2% in low currency. However, with volumes that increased roughly 20%. That said, a shift towards commercial payer coverage is for now holding back revenue. and improving payer collection naturally is a priority for us moving ahead. On the pharma side, revenue was in Swedish kronor 2.9 million, up 95% year over year, 96 in local currency, with pharma test services up 187%, driven by new work orders from existing global pharma partners. So put simply, Q1 delivered strong pharma services growth and a leaner cost base, while US IVD revenue was held back by PMX headwinds, despite actually seeing continued and higher volumes. Before I close, I want to update you on a capital raise that we're executing to fully fund the business through to the next level. We're carrying out now a 29.2 million Swedish kronor rights issue of new Class B shares with preferential subscription rights for existing shareholders at a subscription price of 0.3 Swedish kronor per share at this count of approximately 23% to the theoretical X rights price. Importantly, the rights issue is expected to be fully covered. Our largest shareholder, HDF and family, has agreed to guarantee the amount in full. So the issue is backstopped for its complete amount. The board's resolution on the rights issue was given on September 9th, subject to approval and an extraordinary general meeting with the subscription period targeted to open on October 7th. Together with the cost actions we have already taken, this capital injection will give us the runway that we need to execute on our strategy. Let me now close with a few summary remarks before we open the call for Q&A. We've built real momentum. Our direction is clear and I believe our position in the market is very unique. What took us here to where we are now won't take us to where we want to be next. And I want to be very clear-eyed about that as we look ahead. On performance, this has been a leaner and more focused by BioVica. Pharma services revenue nearly doubled year-over-year, and the cost actions we have taken, they sharpen our cost base going forward. On commercial traction, we secured our ninth working order and expanded MSA from existing global pharma partners, signed a new lab services agreement with the U.S. Cancer Center, and published also new Phase III data. Looking ahead, our execution priorities are a leaner cost base following the Q1 restructuring, a sharper U.S. commercial focus, and continued pharma momentum. And on market position, I see ctDNA and DIVITUM TKA as complementary, not competing. DIVITUM delivers a frequent read on treatment response before imaging, regardless of a tumor's rotation profile. As I've said before, we're not the mutation detector, we're the proliferation monitor. The earliest, the simplest signal that a drug is actually working. That is where our FDA clearance, our evidence base, and our growing number of active U.S. accounts puts us. And I obviously look very much forward to maintaining a close dialogue with the investor community and to keep on sharing further updates as we continue to execute on our strategy. And with that, Fredrik, I'm happy to open the call for questions.

Perfect and thank you for the presentation. So first off a few questions from the investors and participants online. So the first question is improving commercial payer coverage and revenue collection is now an active priority. Could you update us on where you stand with Medicare as well as private insurance coverage?