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Xvivo Perfusion AB’s Mixed Earnings Call: Growth Amid Challenges

Xvivo Perfusion AB’s Mixed Earnings Call: Growth Amid Challenges

Xvivo Perfusion AB ((SE:XVIVO)) has held its Q3 earnings call. Read on for the main highlights of the call.

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The recent earnings call for Xvivo Perfusion AB painted a mixed picture of the company’s current standing and future prospects. While there was significant growth in the Abdominal segment and strategic partnerships were formed to expand services in the U.S., challenges persist in the U.S. lung market, and there are delays in regulatory approvals for heart and liver products. This dual sentiment reflects both optimism and caution as the company navigates its complex market landscape.

Abdominal Segment Growth

The Abdominal segment of Xvivo Perfusion AB achieved remarkable success, marking a record quarter with net sales reaching SEK 55 million and an impressive organic growth of 47%. Liver sales saw a 34% increase in local currencies, while kidney sales surged by 79% year-over-year, highlighting the segment’s robust performance and potential for continued expansion.

Strong Thoracic Segment Gross Margin

The Thoracic segment reported an impressive gross margin of 89%, largely driven by a favorable product mix and a 17% growth in global PERFADEX sales, which remains the product with the highest margin. This strong performance underscores the segment’s profitability despite other challenges.

Successful Partnership for U.S. Service Expansion

Xvivo has strategically partnered with a perfusionist company, gaining access to 175 perfusionists. This collaboration aims to enhance EVLP and organ recovery services in the U.S., positioning the company for improved service delivery and market penetration.

Improved Service Model

In a bid to better align with the OPO system, Xvivo introduced an EVLP product service model, with the first pilot scheduled for Q4. This initiative is expected to streamline operations and enhance service efficiency.

Positive Cash Flow Management

The company reported a positive operating cash flow of SEK 21 million during Q3, achieved through disciplined cost management that effectively offset recruitment costs. This financial prudence is a positive indicator of the company’s operational efficiency.

Challenges in the U.S. Lung Market

The U.S. lung market has faced slower growth in 2025, attributed to resource constraints and a reduction in waitlist numbers, which have collectively impacted growth rates. This presents a challenge that the company needs to address to regain momentum.

Decrease in Thoracic Segment Sales

Thoracic segment sales were recorded at SEK 115 million, with organic growth at -12%. This decline was influenced by fewer XPS machine sales and reduced EVLP activity among high-volume customers, indicating areas that require strategic focus.

Delayed U.S. Heart Regulatory Approval

The timeline for U.S. heart regulatory approval has been extended due to an anticipated expert panel review, delaying the product’s market entry. This setback requires careful navigation to minimize impact on the company’s growth plans.

Paused U.S. Liver Trial

The liver PMA process in the U.S. has been paused as the company explores alternative regulatory routes, potentially delaying market entry. This pause necessitates strategic adjustments to maintain momentum in the liver segment.

Forward-Looking Guidance

Looking ahead, Xvivo Perfusion AB is targeting a 70% gross margin for the Abdominal segment by 2027, supported by strategic partnerships and investments in service segment initiatives. The company reported a 6% organic growth in the top line when adjusted for U.S. heart trial revenue, with a recovery in EBITDA levels. Plans are underway to submit the heart regulatory file to the FDA by Q2 2026, and the company is making strides in its U.S. Continuous Access Protocol.

In conclusion, Xvivo Perfusion AB’s earnings call reflects a company in transition, with significant achievements in the Abdominal segment and strategic moves in the U.S. market. However, challenges in the U.S. lung market and regulatory delays present hurdles that require strategic navigation. The overall sentiment is cautiously optimistic, with a focus on leveraging growth opportunities while addressing existing challenges.

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