Xvivo Perfusion

Fourth quarter 2023 (October 1 - December 31)
• Net sales amounted to SEK 155.7 million (131.5), corresponding to an increase of 18 percent in SEK and 16 percent in local currencies.
• Organic growth accounted for 12 percent and acquired growth for 4 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 14 percent, Abdominal disposables 22 percent and Services 18 percent.
• The gross margin for disposables increased to 81 percent (79). The total gross margin was 75 percent (72).
• Operating income (EBIT) amounted to SEK -16.1 million (2.3) and includes a write-down related to PrimECC totaling SEK -16.4 million. Adjusted EBIT amounted to SEK 0.8 million (8.5)
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 20.7 million (13.6) corresponding to an EBITDA margin of 13 percent (10). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 21.2 million (19.8), corresponding to an adjusted EBITDA margin of 14 percent (15).
• Net profit amounted to SEK 68.5 million (0.7) and was impacted by financial income of SEK 73.7 million (8.9) attributable to fair value valuation of financial liabilities.
• Earnings per share amounted to SEK 2.17 (0.02).
• Cash flow from operating activities amounted to SEK 18.1 million (21.8), primarily due to positive operating income before depreciation and amortization. Total cash flow amounted to SEK -38.2 million (-58.1) impacted by investments in R&D projects of SEK -33.3 million (-26.2).

Significant events during the quarter
• First transplant completed in the US heart preservation trial
• Results from Australian/New Zealand study using XVIVO’s heart technology published
• Milestone reached in Italy with 1,200 lifesaving perfusions performed with Liver Assist
• Write-down related to PrimECC of SEK 17 million which does not affect cash flow or EBITDA
• Financial income of SEK 69.0 million recognized, attributable to write-down of financial liabilities after fair value valuation, not affecting cash flow, operating income (EBIT) or EBITDA
• XVIVO Perfusion Lund AB was merged with the parent company XVIVO Perfusion AB

The period 2023 (January 1 - December 31)
• Net sales amounted to SEK 597.5 million (415.3), corresponding to an increase of 44 percent in SEK and 36 percent in local currencies.
• Organic growth accounted for 30 percent and acquired growth for 6 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 28 percent, Abdominal disposables 53 percent and Services 57 percent.
• Gross margin for disposables increased to 81 percent (79). The total gross margin was 74 percent (72).
• Operating income (EBIT) amounted to SEK 4.2 million (6.4) and includes a write-down related to PrimECC totaling SEK -16.4 million and integration costs SEK-22.1 million. Adjusted EBIT amounted to SEK 42.7 million (14.3).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 80.5 million (48.6), corresponding to an EBITDA margin of 13 percent (12). Adjusted EBITDA amounted to SEK 102.6 million (56.5), corresponding to an adjusted EBITDA margin of 17 percent (14).
• Net profit amounted to SEK 91.8 million (18.4) and was impacted by financial income of SEK 72.0 million (-21.5) attributable to fair value valuation of financial liabilities.
• Earnings per share amounted to SEK 3.07 (0.62).
• Cash flow from operating activities increased to SEK 46.3 million (27.9). Total cash flow amounted to SEK 303.2 million (-176.6), 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 -100.1 million (-111.6).

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 XVIVO’s technology in the period through special permits pending regulatory approval
• A large multicenter study published in The Journal of Hepathology demonstrated improved evidence for the advantages of oxygenated cold perfusion of liver in donation after brain death (DBD)
• Patient inclusion completed in European clinical trial using heart preservation technology
• US FDA grants XVIVO approval to start its IDE clinical study in heart preservation and to include DCD hearts in IDE Clinical Trial in the US
• XVIVO’s heart preservation technology has enabled a second xenotransplant (heart from pig to human)
• The US service offering strengthened by commercial integration of STAR Teams and by a strategic collaboration with MTJ Aviation.
• A directed share issue raised SEK 440 million before transaction costs and was completed with no discount
• The number of shares and votes in XVIVO Perfusion AB (publ) increased by 1,667,551, to a total of 31,499,470 shares and votes.
• Further patient inclusion in the PrimECC study halted.

Events after the end of the period
• UMCG in Groningen, the Netherlands, has demonstrated that prolonged liver perfusion can streamline planning and logistics and enable more liver transplants to be performed during daytime
• The Board of Directors proposes that no dividend be paid for the 2023 financial year and that retained earnings be carried forward