XVIVO Perfusion (XVIVO) Q3 2025 earnings summary

Executive summary

• Q3 2025 net sales were SEK 189 million, down 5% year-over-year, but organic growth excluding Heart trial revenue was 6% in local currencies, with EBITDA margin recovering to 19% as destocking effects subsided.

• Abdominal segment showed strong growth, while Thoracic sales declined due to lower Heart trial revenue, currency effects, and softer Lung market.

• Strategic investments and partnerships in U.S. services and commercial footprint were made to support future Heart business and address resource constraints.

• Regulatory and clinical projects are progressing, but timelines for Heart approval in the EU remain uncertain.

• Operating cash flow was positive in Q3 despite ongoing inventory buildup.

Financial highlights

• Q3 net sales: SEK 189 million, with organic growth of 6% excluding Heart trial revenue; year-to-date net sales: SEK 586 million, up 6% organically excluding trial revenue.

• Gross margin in Q3 was 75%, and year-to-date was 74%, both in line with last year.

• Adjusted EBIT margin in Q3 was 9%; adjusted EBITDA margin was 19% in Q3 and 18% year-to-date.

• Cash position at quarter-end was SEK 280 million, with SEK 120 million available under a credit facility.

• Cash flow from investments was negative SEK 61 million, reflecting CapEx and regulatory investments.

Outlook and guidance

• Priority is obtaining CE mark for Heart in Europe and preparing the U.S. Heart regulatory file for FDA submission.

• Focus on increasing EVLP adoption and expanding service offerings in the U.S., with a strengthened field force.

• Liver Assist in Europe will continue to be supported to increase lives saved; U.S. regulatory pathway for Liver is under review for potential acceleration.

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

• Anticipates gradual recovery in global transplant growth through late 2025 and into 2026.