Third quarter 2023 (July 1 – September 30)
• Net sales amounted to SEK 146.6 million (96.8), corresponding to an increase of 51 percent in SEK and 42 percent in local currencies. • Organic growth accounted for 37 percent and acquired growth for 5 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 23 percent, Abdominal disposables 100 percent and Services 68 percent.
• The gross margin for disposables increased to 80 percent (79). The total gross margin was 73 percent (72).
• Operating income (EBIT) amounted to SEK 5.3 million (-4.7).
• Adjusted EBIT amounted to SEK 14.4 million (-0.7).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 18.9 million (5.9), corresponding to an EBITDA margin of 13 percent (6).
• Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 28.0 million (9.9), corresponding to an adjusted EBITDA margin of 19 percent (10).
• Net profit amounted to SEK 2.3 million (5.4).
• Earnings per share amounted to SEK 0.08 (0.18).
• Cash flow from operating activities increased to SEK 24.8 million (17.0), primarily due to strong operating income before depreciation and amortization. Total cash flow amounted to SEK 424.4 million (-18.4), mainly comprising net proceeds from a new issue of SEK 440 million, and investments in R&D projects totaling SEK -21.5 million (-27.9).
Significant events during the quarter
• A directed share issue raised SEK 440 million before transaction costs and was completed with no discount
• US FDA grants XVIVO approval to include DCD hearts in IDE Clinical Trial
• XVIVO’s heart preservation technology was used in a second successful xenotransplant (heart from pig to human)
• 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
The period 2023 (January 1 – September 30)
• Net sales amounted to SEK 441.8 million (283.8), corresponding to an increase of 56 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 34 percent, Abdominal disposables 71 percent and Services 75 percent.
• Gross margin for disposables increased to 80 percent (79). The total gross margin was 74 percent (71).
• Operating income (EBIT) amounted to SEK 20.3 million (4.1).
• Adjusted operating income (EBIT) amounted to SEK 41.9 million (5.7).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 59.8 million (35.0), corresponding to an EBITDA margin of 14 percent (12).
• Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 81.4 million (36.6), corresponding to an adjusted EBITDA margin of 18 percent (13).
• Net profit increased to SEK 23.3 million (17.7).
• Earnings per share amounted to SEK 0.78 (0.60).
• Cash flow from operating activities was SEK 28.2 million (6.1). Total cash flow amounted to SEK 341.4 million (-118.5), primarily comprising net proceeds from a new issue totaling SEK 440 million, payment of 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 -66.9 million (-85.4).
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 associated with XVIVO’s heart preservation technology, even in DCD donations
• Significant interest in XVIVO’s heart technology in Australia and New Zealand. Approximately 30 percent of these countries’ heart transplants were performed using our technology in 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)
• 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
• During the period, the number of shares and votes in XVIVO Perfusion AB (publ) has increased by 1,667,551. As of September 30, 2023, there were a total of 31,499,470 shares and votes.
Significant events after the end of the period
• First transplant completed in the US heart preservation trial
CEO comment
“The company’s growth in the first half-year continued into the third quarter, driven by increased use of machine perfusion. We completed a successful capital raising in the quarter, raising SEK 440 million before transaction costs. The strong support from our shareholders means that we are now ready to deliver on our strategy to achieve market leadership in all organs.” – Christoffer Rosenblad, CEO