Biovica rapporterar stark tillväxt när ny vd skärper fokus

Uppsalabaserade Biovica utvecklar och kommersialiserar biomarköranalysen DiviTum TKa, ett blodbaserat test som mäter cellproliferation och möjliggör tidig utvärdering av hur väl en cancerbehandling fungerar. Det initiala fokuset ligger på metastaserad bröstcancer. Sedan den 1 maj leds bolaget av Theis Kipling, tidigare Chief Commercial Officer på Devyser Diagnostics, som tar över efter Anders Rylander i ett planerat ledarskiftet.

Tillväxten under räkenskapsårets sista kvartal var påtaglig. Nettoomsättningen mer än fördubblades till 4,8 miljoner kronor (2,3). För helåret ökade intäkterna med 55 procent till 13,4 miljoner kronor (8,6). Den primära tillväxtdrivaren var Pharma Services, där bolaget säljer analyser och kit till läkemedelsbolag och där försäljningen steg med 72 procent under året.

Inom det affärsområdet växte analystjänsterna särskilt starkt, medan kitförsäljningen minskade. Enligt bolaget speglar detta en tydlig trend: ett växande antal stora läkemedelsbolag skickar prover till Biovica för analys i stället för att köpa kit och genomföra analyserna själva. I den amerikanska diagnostikverksamheten, där analysen säljs via bolagets CLIA-certifierade laboratorium i San Diego, ökade försäljningen med 38 procent under året.

Ny vd skärper organisationen

Rörelseresultatet för helåret förbättrades till -70,1 miljoner kronor (-85,8) och likvida medel uppgick till 70,4 miljoner kronor vid utgången av april. Styrelsen bedömer att bolaget har tillräckliga resurser för minst tolv månader framåt.

I sitt första vd-ord klargör Theis Kipling att hans uppdrag är att göra Biovica mer fokuserat och kommersiellt slagkraftigt genom att rikta resurser mot de möjligheter som skapar störst värde. Han är noga med att betona att ambitionen är mer än ett kostnadsbesparingsprojekt, men budskapet om stramare finansiell disciplin och en mer stringent organisation är tydligt. Det mest konkreta steget hittills är beslutet att inleda förhandlingar om att avsluta de europeiska distributionsavtalen och i stället koncentrera verksamheten kring den amerikanska diagnostikmarknaden och den globala Pharma Services-verksamheten.

Parallellt fortsätter bolaget att bygga sin kliniska evidensbas, med nya data presenterade bland annat vid AACR och ESMO Breast Cancer 2026, samt ett antal publikationer under året. Under räkenskapsåret tecknades ett avtal med Tempus AI i USA för att bredda den kommersiella räckvidden för DiviTum TKa, och bolaget noterar att användningen i USA ökar stadigt.

Vd kommenterar

BioStock kontaktade Biovicas vd Theis Kipling för att få veta mer om resultaten och den skärpta strategin.

You write that your first priority is to ensure Biovica is properly structured, with the right organisation and cost base. Does that mean costs and headcount will be cut?

– We have made deliberate choices about where to focus. The clearest example is discontinuing our EU IVDR regulatory pursuit and the related European distribution agreements. That removes complexity and frees up both management attention and capital for where we see the greatest near-term return: the US clinical market and Pharma Services globally. We are a small company every resource allocation decision must be tied directly to value creation. Some areas will shrink so that others get more investment. That is not restructuring for its own sake; it is capital discipline in service of growth.

You want to prioritise the markets, customer segments and partnerships with the greatest potential. Can you be more specific about what those are, and what you mean by the most value-creating opportunities?

– Three areas, in priority order. First, Pharma Services supporting pharma companies in clinical trials as an exploratory or companion biomarker. Low capital intensity, recurring revenue, and it generates the clinical data that drives commercial adoption downstream.

– Second, the US clinical market specifically oncologists managing HR+/HER2− metastatic breast cancer on CDK4/6 inhibitor therapy. A defined, accessible patient population with a real clinical question DiviTum TKa is built to answer.

– Third, strategic partnerships, in-licensing, or acquisitions that extend our menu i.e. an ESR1 mutation assay, additional oncology biomarkers, or distribution relationships that deepen US penetration are all relevant strategy possibilities.

The termination of the EU distribution agreements seems to be the clearest element of the reorganisation. What does it mean for Biovica’s presence in Europe going forward?

– Europe is a future opportunity, not a current investment priority. We are pausing active clinical commercialization, not exiting permanently. Pursuing IVDR certification requires substantial time and capital, and near-term returns do not justify that investment at this stage. Our Pharma Services team continues to work with European pharma clients, so we retain a meaningful European presence through that channel. When we have a stronger US proof point and the right regulatory pathway, Europe becomes attractive again and we will be ready to move.

Pharma Services is your primary growth engine, but it relies on individual assignments that can vary significantly between quarters. How sustainable is the strong sales momentum we are seeing now?

– Quarter-to-quarter variability is real and we will not pretend otherwise. What matters is who is buying: large pharma companies integrating DiviTum TKa into clinical trial design as an efficacy biomarker. Those engagements are typically multi-year and generate follow-on work. What we are building is a roster of pharma customers who have validated the assay in their own programs that is both a revenue base and a reference asset for every next conversation. Strong quarters with some variability are the right profile for a company building something meaningful. Thin, steady revenue that never compounds is not.

Adoption of DiviTum TKa in the US is growing steadily. What needs to happen for that to shift into a higher gear, particularly following the launch in early breast cancer?

– Three things, in sequence. First, reimbursement clarity consistent payer coverage, which we are actively pursuing through our market access and revenue cycle management work.

– Second, NCCN guideline inclusion being the clinical signal that tells oncologists DiviTum TKa belongs in the standard workflow. That requires clinical utility data from a prospective patient population, ideally anchored to a major academic centre. The IDN opportunity we have flagged is a potential accelerant here.

– Third, early breast cancer a second distinct commercial story that significantly extends our addressable market.

– These are not quick wins. They are the right sequence, and we are executing against each of them.

Cash stands at just over SEK 70 million and the board sees at least twelve months of runway. What does the financing picture look like beyond that, and what role do the TO4 B warrants play?

– We have over SEK 70 million in cash, covering at least twelve months of operations. The TO4 B warrants represent a potential additional capital injection if exercised, subject to share price performance. Beyond that window, our financing strategy is milestone-driven: Pharma Services revenue growth, US clinical adoption data, and progress on the strategic agenda. My focus is disciplined execution, which builds value and, in turn, strengthens our financing position.