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Report on Operations 2022

Fourth quarter 2022 (October 1 – December 31)
• Net sales amounted to SEK 131.5 million (85.9), corresponding to an increase of 53 percent in SEK and 34 percent adjusted for currency effects. Organic growth accounted for 27 percent and acquired growth for 7 percent.
• All business areas delivered underlying growth adjusted for currency effects: Thoracic 26 percent, Abdominal 27 percent and Services 44 percent.
• The gross margin for disposables increased to 79 percent (77). The total gross margin was 72 percent (73).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 13.6 million (-0.1) corresponding to an EBITDA margin of 10 percent (0). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 19.8 million (9.6), corresponding to an adjusted EBITDA margin of 15 percent (11).
• Operating income (EBIT) amounted to SEK 2.3 million (-8.3). Adjusted EBIT amounted to SEK 8.5 million (1.4).
• Net profit amounted to SEK 0.7 million (12.2). Earnings per share amounted to SEK 0.02 (0.42).
• Cash flow from operating activities increased to SEK 21.8 million (-0.6), a result of increased sales and positive EBITDA. Total cash flow amounted to SEK -58.1 million (111.2) and was primarily impacted by the initial purchase price for XVIVO S.r.l. of SEK -39.4 million, payment of the withheld portion of the purchase price for STAR Teams Inc. Of SEK -7.0 million and investments in R&D projects of SEK -26.2 million.

Significant events during the quarter
• Positive results presented from the Australian and New Zealand heart preservation study.
• XVIVO completes the acquisition of the machine and perfusion business from its Italian distributor Avionord S.r.l.
• The new share issue directed at the shareholders of Avionord S.r.l. increased the number of shares and votes in XVIVO Perfusion AB (publ) by 269,952.
• XVIVO’s Board of Directors appoints Christoffer Rosenblad as CEO.
• XVIVO strengthens its management team by appointing Lena Hagman as Chief Operating Officer, COO.

Events after the end of the period
• The Board of Directors proposes that no dividend be paid for the 2022 financial year and that retained earnings be carried forward.

The period 2022 (January 1 – December 31)
• Net sales amounted to SEK 415.3 million (258.4), corresponding to an increase of 61 percent in SEK and 45 percent adjusted for currency effects. Organic growth accounted for 30 percent and acquired growth for 15 percent.
• All business areas delivered underlying growth adjusted for currency effects: Thoracic 32 percent, Abdominal 24 percent and Services 39 percent.
• The gross margin for disposables increased to 79 percent (76). The total gross margin was 72 percent (73).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 48.6 million (13.8) corresponding to an EBITDA margin of 12 percent (5). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 56.5 million (29.5), corresponding to an adjusted EBITDA margin of 14 percent (11).
• Operating income (EBIT) amounted to SEK 6.4 million (-18.5). Adjusted operating income (EBIT) amounted to SEK 14.3 million (-2.7).
• Net profit increased to SEK 18.4 million (8.2). Earnings per share amounted to SEK 0.62 (0.28).
• Cash flow from operating activities increased to SEK 27.9 million (-12.1). Total cash flow amounted to SEK -176.6 million (34.8), and included a final additional purchase price payment relating to the acquisition of Organ Assist (XVIVIO B.V.) of SEK -21.0 million, an initial purchase price relating to XVIVO S.r.l. of SEK -39.4 million, payment of the withheld portion of the purchase price for STAR Teams Inc. Of SEK -7.0 million and investments in R&D projects of SEK -111.6 million.

Significant events in the reporting period
• XVIVO’s heart technology is used in the world’s first ever successful heart xenotransplantation (pig to human)
•     Kidney Assist Transport granted 510(k) clearance by the US FDA
• XVIVO obtains its first certificate under EU Medical Device Regulation (MDR) for Kidney Assist Transport
• An IDE application for the heart preservation study in the US was submitted to the FDA
• XVIVO gains regulatory approval in China for PERFADEX® Plus
• XVIVO signs an agreement to acquire 100 percent of the shares in Avionord S.r.l’s machines and perfusion business – the company’s distributor in Italy.
• Liver Assist granted a Breakthrough Device Designation by the US FDA
• XVIVO holds its second capital markets day
• XVIVO’s CEO, Dag Andersson, passes away and Christoffer Rosenblad takes over as Acting CEO

CEO comment
“2022 was a strong year for XVIVO. Sales amounted to SEK 415 million (258) with organic growth of 30 percent in local currencies. The final fourth quarter testifies to a continued recovery of transplant activity worldwide and strong momentum for machine perfusion in particular. XVIVO’s sales during the quarter set new records and totaled SEK 132 million (86). All of the business areas delivered strong growth, both year-on-year and sequentially. In summing up 2022, it is clear that XVIVO has achieved several significant milestones during the year toward our goal of becoming the leading transplantation company for all major organs. The strong finish to 2022 means we have the wind in our sails and self-confidence, and we are determined to make 2023 yet another successful year for XVIVO” – Christofer Rosenblad, CEO.

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