Xvivo Perfusion AB (publ)

Q2 net sales were SEK 239 million, up 36% organically in local currencies. EBITDA was SEK 45 million, or about a 19% margin, and gross margin was 71%. Thoracic sales were SEK 158 million (+53% organic), abdominal sales were SEK 65 million (+26% organic), and services sales were SEK 15 million (-25%). Within thoracic, heart sales were SEK 24 million and EVLP disposable sales grew 69%; within abdominal, kidney grew 72% and liver sales grew 11% in local currencies. Operating cash flow was SEK 63 million in the quarter and SEK 129 million year-to-date; cash flow from investments was minus SEK 68 million in the quarter, and cash ended at SEK 305 million. Management said the company aims to submit the FDA heart file during this quarter, expects feedback on a European heart clarification step during Q3, and is preparing to decide the U.S. liver regulatory pathway in the Q3 timeframe. They also said they believe they can end 2026 cash positive if sales track as expected.

The CEO framed the quarter as evidence that XVIVO’s model is scalable: higher sales translated into better EBITDA and improved underlying cash flow, even while the company kept investing in commercial capacity, regulatory work, and production scale-up. He emphasized broad momentum across thoracic and abdominal, especially lung market recovery, growing kidney adoption, and rising interest in heart technology in Europe, the U.S., and Australia. His tone was upbeat but still cautious on regulatory timing, repeatedly noting that approvals are hard to predict and that the company is focused on execution until launch.

The CFO highlighted broad-based growth and profitability, pointing to SEK 239 million in Q2 sales, 36% organic growth, SEK 45 million of EBITDA, and a 71% gross margin. He broke out the margin drivers: thoracic gross margin was 83%, abdominal gross margin was 57% due to mix and pricing conditions, and services gross margin was 10% because of low recovery volumes and capacity investment. On cash, he said operating cash flow was SEK 63 million in the quarter, investments were minus SEK 68 million mainly for regulatory and product development, and the company ended with SEK 305 million in cash after essentially break-even total cash flow for the first half.

Analysts focused on whether heart revenue was being boosted by box placements or mainly by disposables, and management said Q2 and Q1 had limited HeartBox sales, with the main contribution coming from disposables and safety-stock kits. On the OPO rollout, management said the first OPO had about 20 LP in the first half, the next two OPOs are still ramping, and it’s too early to quantify the revenue potential precisely. Questions on the FDA heart submission and European CE timing drew cautious answers: the company expects to submit the heart file during this quarter, but is waiting on validation and product-aging data, while CE timing in Europe remains uncertain though management still hopes for 2026. Analysts also asked about abdominal pricing pressure and R&D step-up; management said pricing pressure is mainly in lower-income European markets and that Q2 R&D/CapEx will ease in H2, though the CE mark would add about SEK 25 million per year in amortization.