XVIVO Perfusion (XVIVO) Q3 2026 earnings summary

Executive summary

• Q3 net sales were SEK 252.6m, up 34% reported and 32% organically; EBITDA was SEK 52.0m and margin rose to 21% from 19%.

• January–September sales reached SEK 732.5m, up 25% reported and 30% organically; EBITDA margin increased to 20% from 17%.

• Heart Assist Transport gained European CE marking and advanced through FDA PMA review; Thoracic led growth while Services remained weak.

Financial highlights

• Q3 sales growth comprised 32% organic growth and a 2% currency effect; organic growth excluding trial revenue was 33%.

• Q3 gross profit was SEK 178m, EBIT SEK 28.0m and EBITDA SEK 52.0m, versus SEK 142m, SEK 17.9m and SEK 35.9m, respectively, a year earlier.

• Q3 net profit was SEK 44.6m versus SEK 4.3m; EPS was SEK 1.42 versus SEK 0.14, including SEK 7.1m in exchange-rate differences on cash and cash equivalents.

• 9M net profit was SEK 97.2m versus a SEK 6.5m loss; EPS was SEK 3.09 versus a SEK 0.21 loss. Financial income and expenses were SEK 29.5m versus SEK -54.2m.

• 9M operating cash flow was SEK 181.8m versus SEK 14.1m; total cash flow was SEK 1.9m versus SEK -103.0m.

Outlook and guidance

• Heart Assist Transport U.S. launch is targeted for late 2027, subject to FDA review and approval; European rollout continues in 2027, with Canada and Australia also planned.

• Liver Assist 510(k) submission is targeted for H1 2027 and U.S. launch for early 2028; timing is subject to regulatory review.

• Kidney growth is expected to be ~30% next year but component shortages and a regulatory transition may constrain supply; higher growth is expected to return from early 2027.

• Heart Assist Europe Tier 2 onboarding is targeted for December 2026; broader uptake depends on reimbursement and center-by-center rollout. Sales-force expansion ahead of Heart and Liver launches may cause a slight H2 margin dip next year.

• Static cold-storage lung sales are planned to grow ~5% next year; new customers may offset a large U.S. customer’s potential EVLP transition, whose timing and impact remain uncertain.