XVIVO Interim Report Jul Sep 2026
Interim Report January – September 2026
Third quarter 2026 (Jul-Sep)
• Net sales amounted to SEK 252.6 million (189.1), corresponding to a growth of 34 percent in SEK.
• Organic growth was 32 percent in local currencies. Excluding revenue from heart trials, the organic growth was 33 percent.
• Thoracic sales increased by 51 percent in local currencies and by 52 percent excluding revenue from heart trials.
• Abdominal sales increased by 12 percent in local currencies.
• Services sales decreased by -28 percent in local currencies.
• Total gross margin was 70 percent (75).
• Operating income (EBIT) amounted to SEK 28.0 million (17.9).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 52.0 million (35.9), corresponding to an EBITDA margin of 21 percent (19).
• Net profit amounted to SEK 44.6 million (4.3), impacted by exchange rate differences in cash and cash equivalents of SEK 7.1 million (0.7).
• Earnings per share amounted to SEK 1.42 (0.14).
• Cash flow from operating activities was SEK 53.0 million (20.6), primarily impacted by an increase in sales.
• Total cash flow amounted to SEK 1.2 million (-43.8), impacted by investments in R&D projects of SEK -37.1 million (primarily related to regulatory processes for heart).
Significant events in the quarter
• XVIVO receives CE certificates for XVIVO Heart Assist Transport System
• XVIVO granted additional patient enrollment in the US PRESERVE CAP study for XVIVO Heart Assist Transport
• XVIVO announces FDA receipt of PMA application for the XVIVO Heart Assist Transport System
The period 2026 (Jan-Sep)
• Net sales amounted to SEK 732.5 million (586.0), corresponding to a growth of 25 percent in SEK.
• Organic growth was 30 percent in local currencies. Excluding revenue from heart trials, the organic growth was 28 percent in local currencies.
• Thoracic sales increased by 43 percent in local currencies and by 39 percent excluding revenue from heart trials.
• Abdominal sales increased by 21 percent in local currencies.
• Services sales decreased by -21 percent in local currencies.
• Total gross margin was 71 percent (74).
• Operating income (EBIT) amounted to SEK 84.9 million (51.6).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 148.0 million (102.5), corresponding to an EBITDA margin of 20 percent (17).
• Net profit amounted to SEK 97.2 million (-6.5), impacted by exchange rate differences in cash and cash equivalents of SEK 19.2 million (-32.6).
• Earnings per share amounted to SEK 3.09 (-0.21).
• Cash flow from operating activities was SEK 181.8 million (14.1), primarily impacted by an increase in sales.
• Total cash flow amounted to SEK 1.9 million (-103.0), impacted by investments in R&D projects of SEK -131.7 million (primarily related to regulatory processes for heart).
Significant events in the period
• Management change at XVIVO – CFO transitions to new role
• Preliminary one-year follow-up data from the US PRESERVE heart preservation trial was presented at ISHLT. The trial met its pre-specified primary endpoints; overall success rate at 30 days and one-year patient survival.
• Results from first clinical trial using hypothermic oxygenated perfusion (HOPE) in direct procurement DCD heart transplantation was presented at ISHLT. The trial met its pre-specified primary endpoints on one-year patient survival.
• One-year follow-up results from XVIVO’s European multicenter heart trial published in the European Heart Journal
• Regulatory derogation and reimbursement in France enable life-saving use of XVIVO’s heart technology
CEO-comment
“The third quarter continued with good momentum, reflecting growing adoption of XVIVO’s technologies. We delivered strong organic growth, improved profitability and positive cash flow, while advancing key regulatory and commercial priorities. I am very proud that XVIVO achieved a major milestone during the quarter with the obtained CE marking of XVIVO Heart Assist Transport, making our innovative heart preservation technology commercially available across Europe. With important launches and market opportunities ahead, we remain focused on strong execution through year-end and on building the foundation for 2027 and 2028. It will be two important years for XVIVO as we continue building the company toward our ambition to become the preferred partner throughout the transplant process.” - Christoffer Rosenblad, CEO