Xvivo Perfusion

Second quarter 2023 (Apr 1 - Jun 30)
• Net sales amounted to SEK 154.6 million (94.3), corresponding to an increase of 64 percent in SEK and 52 percent in local currencies. Organic growth accounted for 46 percent and acquired growth for 6 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 47 percent, Abdominal disposables 40 percent and Services 79 percent.
• The gross margin for disposables increased to 80 percent (78). The total gross margin was 75 percent (72).
• Operating income (EBIT) amounted to SEK 3.8 million (4.1). Adjusted EBIT amounted to SEK 15.1 million (1.1).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 17.2 million (14.4) corresponding to an EBITDA margin of 11 percent (15). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 28.5 million (11.3), corresponding to an adjusted EBITDA margin of 19 percent (12).
• Net profit amounted to SEK 6.9 million (7.5). Earnings per share amounted to SEK 0.23 (0.26).
• Cash flow from operating activities increased to SEK 15.7 million (-1.6). Total cash flow amounted to SEK -34.5 million (-36.6), impacted by contingent consideration from the acquisition of Avionord (XVIVO S.r.l.) of SEK -10.9 million, the final part payment of the initial purchase consideration regarding the acquisition of STAR Teams of SEK -6.8 million and investments in R&D projects of SEK -22.7 million.

 Significant events during the quarter
• IDE application for XVIVO’s heart preservation technology was approved by the US FDA
• Patient inclusion completed in European clinical trial using heart preservation technology
• US service offering strengthened by commercial integration of STAR Teams
• Change in number of shares and votes in XVIVO Perfusion AB (publ)

The period 2023 (Jan 1 - Jun 30)
• Net sales amounted to SEK 295.2 million (186.9), corresponding to an increase of 58 percent in SEK and 45 percent in local currencies. Organic growth accounted for 39 percent and acquired growth for 6 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 40 percent, Abdominal disposables 56 percent and Services 77 percent.
• Gross margin for disposables increased to 80 percent (78). The total gross margin was 75 percent (71).
• Operating income (EBIT) amounted to SEK 15.0 million (8.8). Adjusted operating income (EBIT) amounted to SEK 27.6 million (6.4).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 40.9 million (29.1), corresponding to an EBITDA margin of 14 percent (16). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 53.4 million (26.7), corresponding to an adjusted EBITDA margin of 18 percent (14).
• Net profit increased to SEK 21.1 million (12.3). Earnings per share amounted to SEK 0.71 (0.42).
• Cash flow from operating activities was SEK 3.3 million (-10.9). Total cash flow amounted to SEK -83.0 million (-100.2), impacted by contingent consideration from the acquisition of Avionord (XVIVO S.r.l.) of SEK -10.9 million, the final part payment of the initial purchase consideration regarding the acquisition of STAR Teams of SEK -6.8 million and investments in R&D projects of SEK -45.4 million.

Significant events in the reporting period
• Successful integration of Avionord M&P
• A pre-clinical study published in The Journal of Heart and Lung Transplantation demonstrated advantages with XVIVO’s heart preservation technology even in donation after circulatory death (DCD)
• Significant interest in XVIVO’s heart technology in Australia and New Zealand. Approximately 25 percent of these countries’ heart transplants were performed using our technology during the period
• A large multicenter study published in The Journal of Hepathology demonstrated improved evidence for the advantages of oxygenation cold perfusion of liver in donation after brain death (DBD)

Significant events after the end of the period
• Strategic collaboration with MTJ Aviation aimed at strengthening XVIVO’s service for organ retrieval in the US
• Further patient inclusion in the PrimECC study concluded. Study data will be analyzed and strategic opportunities evaluated

CEO comment
“The positive trend for our business continued in the second quarter. In lung transplantation, we are seeing positive growth in our main market, the US and in Europe strong activity in liver perfusion continues. We also reached key regulatory milestones in heart preservation in the quarter. XVIVO is well equipped to capitalize on the opportunities continuously developing within machine perfusion. The key to success is our sharp focus on core operations, investments in increased production capacity, regulatory approval for heart preservation globally and liver perfusion in the US and continuing to build a world-class organization.”
- Christoffer Rosenblad, CEO