Regulatory press release

Interim report January–September 2025

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

About Us

Founded in 1998, XVIVO is the only medical technology company dedicated to extending the life of all major organs - so transplant teams around the world can save more lives. Our solutions allow leading clinicians and researchers to push the boundaries of transplantation medicine. XVIVO is headquartered in Gothenburg, Sweden, and has offices and research sites on two continents. The company is listed on Nasdaq Stockholm under the ticker symbol XVIVO. More information can be found on the website www.xvivogroup.com.