XVIVO Perfusion (XVIVO) Q2 2025 earnings summary

Executive summary

• Q2 2025 net sales were SEK 178.3 million, down 15% year-over-year, with organic growth at -11% due to slower lung market, destocking, and currency headwinds.

• Strong growth in U.S. lung sales to clinics and OPOs (+26%), European liver (+32%), and U.S. kidney sales (+47%), while Thoracic and Services segments declined.

• Key milestones included positive ISHLT reception, progress in EU heart approval, FDA approvals for key clinical studies, and Canadian abdominal portfolio launch.

• Clinical trial results for heart and liver products demonstrated strong efficacy and cost-effectiveness, supporting future commercialization.

• Strategic investments in R&D, inventory, and production capacity were made to support future growth, especially in heart and liver technologies.

Financial highlights

• Q2 2025 net sales: SEK 178.3 million (down from SEK 210.3 million in Q2 2024); organic growth -11%; H1 2025 net sales: SEK 396.9 million, flat year-over-year.

• Gross margin stable at 74% for Q2 and YTD; thoracic gross margin 86%.

• Adjusted EBITDA margin at 13% for Q2 (down from 24%); rolling 12 months at 19%.

• SEK 9 million positive operating cash flow in Q2; cash position at SEK 323 million as of June 30, 2025.

• SEK 72 million invested in Q2, mainly for U.S. clinical trials, device placements, and regulatory projects.

Outlook and guidance

• Focus on restructuring costs to invest in field force, customer-facing roles, and commercial capacity.

• Preparing for heart product launch in Europe, Pacific, and Canada; U.S. CAP support and first U.S. liver clinical trial patient in H2 2025.

• Main growth drivers expected to be EVLP in the U.S. and liver/kidney in Europe, with additional growth from heart post-approval.

• Long-term outlook remains strong, with machine perfusion and service models expected to drive future growth.

• Continued investments planned in regulatory processes, commercial capacity, and inventory to meet rising demand.