Xvivo Perfusion

Fourth quarter 2025 (Oct-Dec)
• Net sales amounted to SEK 226.1 million (227.6), corresponding to growth of -1 percent in SEK and organic growth of 10 percent in local currencies.
• Organic growth, excluding revenue from heart trials, was positive at 12 percent in local currencies.
• The Abdominal business area delivered sales growth of 30 percent in local currencies. Thoracic increased by 9 percent and 12 percent excluding revenue from trials in local currency. Services decreased by -21 percent due to reduced volume in organ recoveries.
• Total gross margin was 73 percent (77).
• Operating income (EBIT) amounted to SEK 36.8 million (15.5).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 56.1 million (51.9), corresponding to an EBITDA margin of 25 percent (23).
• Net profit amounted to SEK 31.6 million (36.4), impacted by currency effects in cash and cash equivalents of SEK -5.8 million (17.2).
• Earnings per share amounted to SEK 1.01 (1.16).
• Cash flow from operating activities increased and totaled SEK 86.9 million (62.1). Total cash flow also increased and amounted to SEK 17.9 million (-51.7). Investments in R&D projects amounted to SEK -43.1 million.

The period 2025 (Jan-Dec)
• Net sales amounted to SEK 812.2 million (822.4), corresponding to growth of -1 percent in SEK and 4 percent in local currencies. Organic growth amounted to 3 percent in local currencies.
• Organic growth, excluding revenue from heart trials, was positive at 8 percent in local currencies.
• The Abdominal business area delivered sales growth in local currencies of 30 percent. Thoracic decreased by -2 percent but increased by 4 percent excluding revenue from trials. Services decreased by -5 percent.
• Total gross margin was 74 percent (75).
• Operating income (EBIT) amounted to SEK 88.4 million (88.4).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 158.6 million (176.1), corresponding to an EBITDA margin of 20 percent (21).
• Net profit amounted to SEK 25.2 million (172.2), impacted by currency effects in cash and cash equivalents of SEK -38.3 million (12.9). • Earnings per share amounted to SEK 0.80 (5.47).
• Cash flow from operating activities was SEK 101.1 million (111.3). Total cash flow amounted to SEK -85.1 million (-143.4), primarily impacted by investments in R&D projects of SEK -152.8 million and utilized credit facility of SEK 84.2 million.

Significant events in the quarter
• Partnership agreement signed with Perfusion Solution Inc (PSI) to broaden service offering in the U. S.

Significant events in the reporting period
• FDA approval of the IDE application for the DELIVER study using Liver Assist.
• FDA approval for continued use of XVIVO’s heart technology through the PRESERVE CAP study
• XVIVO presents convincing 12-month follow-up results from heart trial NIHP2019
• XVIVO honored with 2025 SACC-USA Business Award
• First patient enrolled in US PRESERVE CAP study for XVIVO Heart Assist Transport
• Delay in CE approval for XVIVO’s perfusion solution for heart preservation

CEO-comment
“Net sales for the fourth quarter amounted to SEK 226 million (228), bringing full-year 2025 net sales to SEK 812 million (822). Organic growth, excluding revenue from heart trials, amounted to 12 percent in local currency during the fourth quarter, primarily driven by a recovery in lung and continued strong development in liver and kidney. EBITDA continued to strengthen sequentially and amounted to 25 percent (23), providing a clear indication of the scalability of our business model. We are also pleased that operating cash flow remains positive; the fourth quarter result of SEK +87 million was a record and reflects focused efforts in cost optimization and working capital management. As a result, we enter 2026 with a solid financial position, enabling us to continue investing in our customer offering and organization – particularly in the US, where during 2026 we will continue to build an organization ready to deliver a full-scale product launch of XVIVO Heart Assist Transport and Kidney Assist Transport in 2027.” - Christoffer Rosenblad, CEO