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Introduction & Market Context
XVIVO Perfusion AB (STO:XVIVO) presented its Q2 2025 earnings on July 11, 2025, revealing a significant downturn in performance after a strong first quarter. The company reported a 15% total decline in net sales, with organic growth falling 11% year-over-year, a stark contrast to the 14% organic growth reported in Q1. Despite these challenges, the stock showed resilience, trading up 3.39% to SEK 299.20 on the day of the presentation.
The company attributed the disappointing results primarily to market headwinds in its core thoracic segment, particularly in the US lung transplant market, where public healthcare funding cuts and temporarily reduced waiting lists at some centers have created uncertainty.
Quarterly Performance Highlights
XVIVO reported Q2 2025 net sales of SEK 178 million, down from SEK 210 million in the same period last year, representing a 15% total decline. Organic growth was negative 11%, with currency effects contributing an additional 6% decline, partially offset by 2% acquired growth.
The company’s profitability metrics also suffered, with adjusted EBITDA falling to 13% from 24% in the prior year period. Gross profit declined to SEK 133 million from SEK 158 million, though the overall gross margin remained relatively stable at 74%.
Performance varied significantly across XVIVO’s three business segments. The thoracic segment, which includes lung and heart transplantation products and represents the company’s largest business area, saw the steepest decline with net sales of SEK 105 million, down from SEK 141 million in Q2 2024, representing a 19% organic decline.
In contrast, the abdominal segment emerged as a bright spot, with net sales of SEK 52 million, up from SEK 47 million in Q2 2024, representing 19% organic growth. This segment, which includes liver and kidney transplantation products, now accounts for a larger portion of XVIVO’s business, with liver sales reaching SEK 38 million (up from SEK 33 million) and kidney sales holding steady at SEK 14 million.
The services segment, XVIVO’s smallest business area, reported net sales of SEK 21 million, down slightly from SEK 23 million in Q2 2024, representing a 1% organic decline. This segment includes organ recoveries (14% of segment sales) and digital services (86%).
Market Challenges
XVIVO’s presentation highlighted several market challenges affecting its performance, particularly in the US lung transplant market. The company noted lower activity than expected, with flat growth in lung transplants (5% in Q2 versus last year) and cuts in public healthcare funding causing uncertainties and cost pressure.
Some transplant centers are experiencing temporarily reduced waiting lists, and there has been a disproportionate slowdown in EVLP (Ex Vivo Lung Perfusion), a key technology for XVIVO. The company also mentioned destocking at its largest customer, though it noted 21% EVLP growth at other customers.
Despite these challenges, XVIVO continues to execute on its EVLP strategy, selling two additional XPS (XVIVO Perfusion System) units in Q2, including one to a newly launched, high-ambition program. The company is focusing on geographic expansion in the US and targeting Organ Procurement Organizations (OPOs).
Clinical & Regulatory Progress
While financial results disappointed, XVIVO highlighted significant progress in clinical trials and regulatory approvals that could drive future growth. The company presented 12-month follow-up results from its EU heart trial at the International Society for Heart and Lung Transplantation (ISHLT) conference in Boston in April 2025.
The results showed a 76% risk reduction in severe Primary Graft Dysfunction (PGD), the leading cause of mortality after heart transplantation. This translated to improved survival in the XVIVO group (92% versus 86% in the control arm), representing six additional lives saved. The company reported significant interest from participating clinicians at the conference.
XVIVO also highlighted impressive clinical evidence for its Liver Assist technology, including a 64% reduced risk of biliary complications, 74% fewer graft-related complications, and 73% reduced risk of graft loss up to 5 years post-transplant. The technology also demonstrated increased utilization (+70%) and cost-effectiveness (€25,832 mean reduction in transplant-related costs per patient).
The company provided an update on its clinical trial status and timeline, noting that patient enrollment for its heart trials has been completed, with results published in prestigious journals including The Lancet. Commercial launch for its heart technology is targeted for Q3 2025, pending regulatory approvals.
For its liver technology, XVIVO received FDA Breakthrough Device Designation, with IDE application for the DeLIVER trial approved in February 2025. This multicenter trial will include 215 patients across up to 20 centers, with trial initiation planned for Q3 2025.
Financial Position & Outlook
XVIVO’s cash flow and financial position showed some weakening in Q2. Cash flow from operating activities was SEK 9 million, down from SEK 25 million in Q2 2024. The company’s cash position as of June 30, 2025, stood at SEK 323 million, significantly lower than the SEK 481 million reported a year earlier.
Looking ahead, XVIVO’s management expressed continued optimism despite the Q2 challenges. The company noted continued high interest in EVLP globally and is focusing on activation and supporting utilization. It expects to meet critical milestones related to product commercialization and market expansion in 2025, including European approval and launch of XVIVO Heart Assist Transport and initiation of the PMA study for Liver Assist in the US.
The company is also preparing for full portfolio commercialization in Canada and conducting a strategic review of its service offering in the US to become the preferred partner. For the long term, XVIVO emphasized that the demand for transplants is 10 times today’s supply, and the sales value of machine perfusion versus cold static storage is approximately 10 times higher, presenting significant growth opportunities.
Despite the disappointing Q2 results, XVIVO’s continued progress in clinical trials and regulatory approvals, along with its strong position in a growing market, suggests potential for recovery in the coming quarters. However, investors will likely be watching closely for signs of improvement in the core thoracic segment and for the company’s ability to navigate ongoing market challenges.
Full presentation:
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