Xvivo Perfusion

Third quarter 2025 (Jul-Sep)
• Net sales amounted to SEK 189.1 million (198.5), corresponding to growth of -5 percent in SEK and 1 percent in local currencies. Organic growth amounted to -1 percent in local currencies.
• Organic growth, excluding revenue from heart trials, was positive at 6 percent in local currencies.
• The Abdominal business area delivered sales growth of 47 percent in local currencies, and Services delivered growth of 10 percent. Thoracic decreased by -12 percent and -4 percent excluding revenue from heart trials.
• Total gross margin was 75 percent (75). The gross margin for the business areas amounted to: Thoracic 89 percent (82), Abdominal 60 percent (64) and Services 37 percent (38).
• Operating income (EBIT) amounted to SEK 17.9 million (20.5). Adjusted EBIT amounted to SEK 17.6 million (25.4).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 35.9 million (37.1), corresponding to an EBITDA margin of 19 percent (19). Adjusted EBITDA amounted to SEK 35.6 million (42.1) – corresponding to an adjusted EBITDA margin of 19 percent (21).
• Net profit amounted to SEK 4.3 million (85.8), impacted by currency effects in cash and cash equivalents of SEK 0.7 million (-9.6). Earnings per share amounted to SEK 0.14 (2.72).
• Cash flow from operating activities was positive and totaled SEK 20.6 million (22.9) despite continued investments in inventory and supply-chain. Total cash flow amounted to SEK -43.8 million (-21.2) impacted by investments in R&D projects of SEK -34.6 million. Cash and cash equivalents at the end of the quarter amounted to SEK 280.0 million (450.0).

Significant events in the quarter
• 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 communicated in July

The period 2025 (Jan-Sep)
• Net sales amounted to SEK 586.0 million (594.9), corresponding to growth of -1 percent in SEK and 3 percent in local currencies. Organic growth amounted to 1 percent in local currencies.
• Organic growth, excluding revenue from heart trials, was positive at 6 percent in local currencies.
• The Abdominal business area delivered sales growth in local currencies of 31 percent and Services 2 percent. Thoracic decreased by -6 percent but grew 2 percent excluding revenue from trials.
• Total gross margin was 74 percent (74). The gross margin for the business areas amounted to: Thoracic 85 percent (83), Abdominal 64 percent (65) and Services 36 percent (38).
• Operating income (EBIT) amounted to SEK 51.6 million (72.9). Adjusted EBIT amounted to SEK 54.2 million (79.1).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 102.5 million (124.2), corresponding to an EBITDA margin of 17 percent (21). Adjusted EBITDA amounted to SEK 105.1 million (130.1) – corresponding to an adjusted EBITDA margin of 18 percent (22).
• Net profit amounted to SEK -6.5 million (135.8), impacted by currency effects in cash and cash equivalents of SEK -32.6 million (-4.4). Earnings per share amounted to SEK -0.21 (4.31).
• Cash flow from operating activities was SEK 14.1 million (49.2), after increased investments in inventory. Total cash flow amounted to SEK -103.0 million (-91.7), primarily impacted by investments in R&D projects of SEK -109.7 million and utilized credit facility of SEK 84.2 million.

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

CEO comment
“Organic growth, excluding revenue from heart trials, was positive at 6 percent in local currencies, mainly driven by strong sales growth in liver and kidney. EVLP activity among our customers remained subdued during the third quarter, but we see indications of a recovery in demand, and interest from new customers for initiating EVLP programs remains high. EBITDA amounted to 19 percent (21) – a clear improvement compared with the second quarter of the year, which was 13 percent. It is encouraging that operating cash flow was positive despite the continued inventory build-up resulting from our investments in increased production capacity. Through our technologies and services - combining innovation, clinical evidence, and a strong patient focus - we strengthen and improve the transplantation process. Our vision that “no one should die while waiting for a new organ” guides us in our strategic decisions, and we already feel well prepared to meet the opportunities of the coming year.” - Christoffer Rosenblad, CEO