Interim Report January – September 2022

Third quarter 2022 (July 1 – September 30)
•      Net sales amounted to SEK 96.8 million (54.9), corresponding to an increase of 76 percent in SEK and 57 percent adjusted for currency effects. Organic growth accounted for 35 percent and acquired growth for 22 percent.
•      All business areas delivered underlying organic growth adjusted for currency effects: Thoracic 45 percent, Abdominal 1 percent (but 32 percent for disposables) and Services 22 percent.
•      The gross margin for disposables increased to 79 percent (73). The total gross margin was 72 percent (69).
•      Operating income before depreciation and amortization (EBITDA) amounted to SEK 5.9 million (4.2) corresponding to an EBITDA margin of 6 percent (8). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 9.9 million (5.3), corresponding to an adjusted EBITDA margin of 10 percent (10).
•      Operating income (EBIT) amounted to SEK -4.7 million (-4.0). Adjusted EBIT amounted to SEK -0.7 million (-2.9).
•      Net profit increased to SEK 5.4 million (-1.1). Earnings per share amounted to SEK 0.18 (-0.04).
•      Cash flow from operating activities increased to SEK 17.0 million (-8.5), a result of increased sales and less capital tied up in operating receivables. Total cash flow amounted to SEK -18.4 million (-30.0) after investments in R&D projects of SEK -27.9 million
 
Significant events during the quarter
•      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. The acquisition is expected to be completed in the fourth quarter.
•      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

The period 2022 (January 1 – September 30)
•      Net sales amounted to SEK 283.8 million (172.5), corresponding to an increase of 64 percent in SEK and 50 percent adjusted for currency effects. Organic growth accounted for 32 percent and acquired growth for 18 percent.
•      All business areas delivered underlying organic growth adjusted for currency effects: Thoracic 34 percent, Abdominal 22 percent and Services 37 percent.
•      The gross margin for disposables increased to 79 percent (75). The total gross margin was 71 percent (73) due to the segment mix.
•      Operating income before depreciation and amortization (EBITDA) amounted to SEK 35.0 million (13.9) corresponding to an EBITDA margin of 12 percent (8). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 36.6 million (20.0), corresponding to an adjusted EBITDA margin of 13 percent (12).
•      Operating income (EBIT) amounted to SEK 4.1 million (-10.2). Adjusted operating income (EBIT) amounted to SEK 5.7 million (-4.1).
•      Net profit increased to SEK 17.7 million (-4.0). Earnings per share amounted to SEK 0.60 (-0.14).
•      Cash flow from operating activities increased to SEK 6.1 million (-11.5). Total cash flow amounted to SEK -118.5 million (-76.3), and included a final additional purchase consideration payment relating to the acquisition of Organ Assist (XVIVIO B.V.) of SEK -21.0 million and R&D investments of SEK -85.4 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

CEO comment
“A month ago, XVIVO’s CEO Dag Andersson suddenly passed away. Our thoughts are with Dag’s family. A strong management team and organization have been established over the past two years. We are ready to deliver in line with the strategy presented at our capital markets day in September. Our path forward over the next few years is clear: We shall be the world-leader in organ transplantation. XVIVO has developed unique, innovative and world-leading products that put us in a very strong market position.

The third quarter was yet another quarter presenting good sales growth and strong gross margins. We have presented three strong quarters in 2022 and look forward to finishing off the year in the same spirit. XVIVO has earned a reputation for presenting growth while being profitable and we shall continue as before.” – Christoffer Rosenblad, Acting CEO