Xvivo Perfusion

Third quarter 2024 (July 1 - September 30)
• Net sales amounted to SEK 198.5 million (146.6), corresponding to growth of 35 percent in SEK and 41 percent in local currencies.
• Organic growth accounted for 41 percent, and currency effects for -6 percent.
• The Business areas Thoracic and Abdominal delivered underlying organic growth adjusted for currency effects: Thoracic disposables 54 percent and Abdominal disposables 13 percent. The Services business area decreased by 7 percent.
• Gross margin for disposables was 81 percent (80). The total gross margin was 75 percent (73).
• Operating income (EBIT) amounted to SEK 20.5 million (5.3). Adjusted EBIT amounted to SEK 25.5 million (14.4).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 37.1 million (18.9) corresponding to an EBITDA margin of 19 percent (13). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 42.1 million (28.0), corresponding to an adjusted EBITDA margin of 21 percent (19).
• Net profit amounted to SEK 85.8 million (2.3) and was impacted by financial income of SEK 65.2 million (0.1) attributable to fair value valuation of financial liabilities. Earnings per share amounted to SEK 2.72 (0.08).
• Cash flow from operating activities was SEK 22.9 million (24.8). Total cash flow amounted to SEK -21.2 million (424.4) primarily impacted by investments in R&D projects, production facilities, and investments in machine installations at clinics.

Significant events in the quarter
• XVIVO’s European heart preservation study published in The Lancet
• XVIVO enters into an agreement to acquire FlowHawk - a unique communication platform for the transplant process. The transaction officially closed on October 11th
• Financial income of SEK 64.4 million recognized, attributable to write-down of financial liabilities after fair value valuation, not affecting cash flow, operating income (EBIT) or EBITDA

The period 2024 (January 1 - September 30)
• Net sales amounted to SEK 594.9 million (441.8), corresponding to growth of 35 percent in SEK and 36 percent in local currencies.
• Organic growth accounted for 36 percent, currency effect -1 percent.
• All business areas delivered underlying organic growth adjusted for currency effects: Thoracic disposables 44 percent, Abdominal disposables 31 percent and Services 4 percent.
• Gross margin for disposables was 80 percent (80). The total gross margin was 74 percent (74).
• Operating income (EBIT) amounted to SEK 72.9 million (20.3). Adjusted operating income (EBIT) amounted to SEK 79.1 million (41.9).
• Operating income before depreciation and amortization (EBITDA) amounted to SEK 124.2 million (59.8) corresponding to an EBITDA margin of 21 percent (14). Adjusted operating income before depreciation and amortization (EBITDA) amounted to SEK 130.1 million (81.4), corresponding to an adjusted EBITDA margin of 22 percent (18).
• Net profit increased to SEK 135.8 million (23.3) and was impacted by financial income of SEK 59.4 million (-1.7) attributable to fair value valuation of financial liabilities. Earnings per share amounted to SEK 4.31 (0.78).
• Cash flow from operating activities increased to SEK 49.2 million (28.2). Total cash flow amounted to SEK -91.7 million (341.4), primarily impacted by investments in R&D projects, production facilities, and investments in machine installations at clinics.

Significant events in the reporting period
• First-ever transplantation of a donor heart transported across the Atlantic - made possible by XVIVO’s heart technology
• Study in extended hypothermic (cold) perfusion of liver using Liver Assist shows that preservation can last up to 20 hours.
• Results from XVIVO’s European clinical trial, NIHP2019, in heart transplantation presented at ISHLT in Prague.
• New clinical study, ‘HOPE at Heart’, started by XVIVO in Europe on DCD hearts in 20 patients
• Unique initiative, ‘The Bridge – Lungs for Life’, started with the aim of increasing lung transplants in Sweden and Denmark

CEO comment
“The EVLP business in the US was the driving force this quarter, with our US clinical trial for heart also progressing as planned and staying within budget. With strong momentum in our US lung business, we enter the final part of the year with confidence. We are committed to invest in the need for more transplants as we steadily move closer to realizing our vision that nobody should die waiting for a new organ.” - Christoffer Rosenblad, CEO