XVIVO Q1 2025 presentation slides: 16% growth driven by Abdominal segment strength

Introduction & Market Context

XVIVO Perfusion AB (STO:XVIVO) presented its first quarter 2025 results on April 24, showing continued momentum in its mission to increase the availability of life-saving organs for transplantation. The company, which specializes in developing and marketing solutions and systems for organ assessment and preservation, reported solid growth despite mixed performance across its business segments.

XVIVO’s share price reacted negatively to the results, declining 1.02% to SEK 293.60 during the trading session, despite the generally positive financial metrics. The stock has traded between SEK 238.20 and SEK 547.00 over the past 52 weeks.

Quarterly Performance Highlights

XVIVO reported net sales of SEK 219 million for Q1 2025, representing a total growth of 16% compared to the same period last year. This growth was primarily driven by organic growth of 14%, with acquired growth and currency effects each contributing an additional 2%.

The company’s adjusted EBITDA margin improved to 21% from 20% in the previous period, continuing a positive trend in profitability. Gross margin remained strong at 73%, reflecting the company’s focus on higher-margin products and solutions.

As shown in the following comprehensive financial summary:

Segment Analysis

XVIVO’s performance varied significantly across its three business segments: Thoracic, Abdominal, and Services.

The Thoracic segment, which includes heart and lung solutions, delivered net sales of SEK 142 million with organic growth of 16% and an impressive gross margin of 82%. Heart products represented 94% of this segment’s sales, with lung products accounting for the remaining 6%. Geographically, EMEA dominated with 66% of Thoracic sales, followed by Americas (27%) and APAC (7%).

The segment’s detailed performance metrics are illustrated here:

The Abdominal segment was the standout performer with net sales of SEK 57 million, representing robust organic growth of 28%. This segment maintained a healthy gross margin of 63%, though slightly down from 68% in the previous period. Kidney products dominated this segment with 75% of sales, while liver products accounted for 25%. Similar to the Thoracic segment, EMEA was the largest market with 85% of Abdominal sales.

The following chart details the Abdominal segment’s performance:

The Services segment was the only area showing weakness, with net sales of SEK 20 million and an organic decline of 19%. This was partially offset by acquired growth of 13%, resulting in a net decline. The gross margin for this segment was 38%, slightly improved from 36% previously. Digital Services represented 86% of this segment’s revenue, with Organ Recoveries accounting for the remaining 14%.

Clinical and Regulatory Progress

XVIVO highlighted significant progress in its clinical trials and regulatory approvals, which are critical to its long-term growth strategy.

The PRESERVE Heart Trial has completed patient enrollment with 141 patients transplanted using XVIVO heart technology across 20 U.S. transplant programs. The company is now conducting 1-year patient follow-ups, which will be followed by FDA regulatory review. A Continued Access Protocol has been approved, and cost recovery has been established with CMS coverage.

The trial’s scope and progress are illustrated in this map of participating centers:

For liver transplantation, XVIVO received FDA approval in February 2025 for the DeLIVER Trial protocol, which will evaluate dual hypothermic oxygenated perfusion (DHOPE) with XVIVO Liver Assist. This prospective, multi-center trial will involve 20 U.S. transplant programs with 215 planned enrollments, with the first patient expected to be enrolled in Q3 2025. The trial will support a PMA application, and CMS submission is underway to establish reimbursement.

The company is also preparing for a full market launch in Canada, pending MDSAP approval. XVIVO’s full lung portfolio is already approved in Canada, and in Q1 2025, the company received approval for Kidney Assist Transport and Liver Assist. The company hired its first employee in Canada during Q1 and is planning additional hires to support the expansion.

Cash Flow and Financial Position

Despite the positive top-line growth, XVIVO’s cash flow and financial position showed some concerning trends. Cash flow from operating activities was negative at SEK -15 million, compared to a positive SEK 2 million in the same period last year. Total (EPA:TTEF) cash flow was SEK -77 million, down from SEK -43 million in the comparable period.

The company’s cash position as of March 31, 2025, stood at SEK 316 million, significantly lower than the SEK 511 million reported a year earlier. XVIVO maintains a revolving credit facility of €20 million to provide additional financial flexibility.

The following chart illustrates the company’s EBITDA performance, showing a positive trend despite the cash flow challenges:

Forward-Looking Statements

Looking ahead to the remainder of 2025, XVIVO expects continued high interest in EVLP (Ex Vivo Lung Perfusion) globally and plans to leverage enthusiasm for hypothermic oxygenated perfusion across organs including liver, kidney, and heart.

The company anticipates meeting critical milestones related to product commercialization and market expansion, including European approval and launch of XVIVO Heart Assist Transport and initiation of the PMA study for Liver Assist in the U.S.

XVIVO plans to invest in strengthening its organization to support commercial launches in select geographic markets and in improving its supply chain and manufacturing capabilities to meet increased customer demand across its portfolio.

For the long term, the company emphasizes that the demand for transplants is approximately 10 times today’s supply, and that the sales value of machine perfusion versus cold static storage is also about 10 times higher. XVIVO believes its innovative products and R&D pipeline position it well to address this significant market opportunity.

CEO Christoffer Rosenblad summarized the company’s mission with the statement that "Nobody should die waiting for a new organ," underscoring XVIVO’s commitment to increasing the availability of viable organs for transplantation through its innovative technologies and solutions.

Full presentation:

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