Download PDF

1. Company Snapshot

1.a. Company Description

Xvivo Perfusion AB (publ), a medical technology company, develops solutions for organ, tissue, and cell preservation and perfusion in connection with transplantation in Sweden, the United States, North America and South America, Europe, the Middle East, Africa, and the Asia Pacific.The company offers XVIVO System (XPS), an integrated off-the-shelf cardiac bypass system that includes various components needed to safely run normothermic ex vivo lung perfusion (EVLP); XPS Disposable Lung Kit that contains disposables and pre-packed products to suit requirement for sterility; and STEEN Solution, a buffered extracellular solution optimally designed to perfuse the isolated donor lung during EVLP.It also provides Perfadex Plus, an extracellular, low potassium, dextran-based electrolyte preservation solution; XVIVO Silicone Tubing Set for rapid flushing of donor lungs during procurement; and XVIVO LS and XVIVO Disposable Lung Set, a device for EVLP.


In addition, the company offers XVIVO Organ Chamber, a single-use sterile disposable container intended to be used as a temporary receptacle for isolated lungs in preparation for eventual transplantation into a recipient; and XVIVO Lung Cannula Set, a single-use, sterile disposable product.The company was incorporated in 1998 and is headquartered in Gothenburg, Sweden.

Show Full description

1.b. Last Insights on XVIVO

XVIVO Perfusion AB's recent performance was negatively impacted by the European market's decline, with the STOXX Europe 600 Index experiencing a slight downturn due to U.S. trade tariffs and fluctuating monetary policies. The company's Q1 2025 earnings were likely affected by this broader economic uncertainty. Additionally, the recent decline in European stocks, with XVIVO Perfusion AB trading below its fair value, suggests that the company's stock price may be undervalued.

1.c. Company Highlights

2. XVIVO's Q3 2025 Earnings: A Resilient Performance Amidst Challenges

XVIVO reported a 6% organic top-line growth in Q3 2025, excluding U.S. heart trial revenue, with net sales reaching SEK 586 million. The company's EBITDA recovered to expected levels due to the absence of destocking in Q3. The adjusted EBIT margin stood at 9%, while the total gross margin was 75%. The actual EPS came out at '0.255', significantly better than estimates at '-5.905'.

Publication Date: Nov -20

📋 Highlights
  • Organic Top-Line Growth:: 6% growth excluding U.S. heart trial revenue, with net sales at SEK 586 million.
  • Abdominal Segment Progress:: Liver sales achieved >15% penetration in Europe, driving 31% Q3 growth, while kidneys saw 54% Q3 growth in Europe.
  • Heart Product Impact:: Clinical data shows 76% reduction in severe primary graft dysfunction, potentially saving 6 patients/year and >400 globally annually.
  • U.S. Approval Timeline:: Heart product aims for FDA filing by Q2 2026, with potential Q4 2026 launch if 510(k) pathway is approved swiftly.
  • Financial Health:: EBITDA recovered to expected levels, 75% gross margin, and ended Q3 with SEK 280 million cash plus SEK 120 million credit facility.

Segmental Performance

The Thoracic segment faced challenges due to lower heart study revenue in the U.S. and a softer Q3 lung market. In contrast, the Abdominal segment showed significant progress, with liver sales penetrating above 15% in many European countries. Kidney sales growth remained below 15% penetration in many countries, but customer feedback indicated improved kidney condition after perfusion with the Kidney Assist Transport.

Services Segment and U.S. Market

The Services segment did not meet expectations in the U.S., prompting the company to execute a plan to improve the service business. XVIVO aims to become a preferred partner to transplant teams by investing in the service segment. The company is working to improve the organ transplant system in the U.S., which is under stress due to poor communication and underutilization of technology.

Valuation and Outlook

With a P/E Ratio of 47.48 and an EV/EBITDA of 59.04, the market seems to be pricing in significant growth expectations. XVIVO's long-term outlook remains intact, with a demand for 10 times the current supply and a sales value for machine perfusion 10 times that of static cold perfusion. The company's efforts to improve its services and expand its product portfolio are expected to drive growth. Analysts estimate next year's revenue growth at 22.2%, indicating a positive outlook.

Regulatory Updates and Future Prospects

XVIVO is awaiting regulatory approval for heart in Europe and expects European heart penetration to mimic what has been seen in Australia. The company is exploring alternative regulatory pathways for liver in the U.S., including 510(k), to enable faster approval and better patient access. Christoffer Rosenblad mentioned that the next regulatory filing of heart study results could be announced Q2 '26, potentially leading to U.S. market approval by Q4 next year.

3. NewsRoom

Card image cap

What New Catalysts Are Reshaping the Narrative for Xvivo Perfusion?

Dec -04

Source:

Card image cap

Why The Narrative Around Xvivo Perfusion Is Shifting With Recent Analyst Developments

Nov -19

Source:

Card image cap

Interim Report January-September 2025

Oct -23

Source:

Card image cap

Conference Call on Interim Report July-September 2025

Oct -13

Source:

Card image cap

How Recent Developments Are Shaping the Xvivo Perfusion Growth Story

Oct -08

Source:

Card image cap

Nomination Committee of XVIVO Perfusion AB (publ)

Sep -05

Source:

Card image cap

Organ Preservation Market Outlook Report 2025-2030: University of Wisconsin Solution Leads the Way in Organ Preservation with Largest Market Share

Aug -18

Source:

Card image cap

Delay in CE Approval for XVIVO's Perfusion Solution for Heart Preservation

Jul -28

Source:

4. Business Breakdown

4.a. Revenues by Country

4.b. Revenues by Segment

5. Expected revenues mid-term growth (8.57%)

6. Segments

Thoracic

Expected Growth: 8.5%

Thoracic segment's 8.5% growth is driven by increasing adoption of Ex Vivo Lung Perfusion (EVLP) technology, rising lung transplantation rates, and growing demand for high-quality organs. Additionally, Xvivo Perfusion's innovative products and services, such as the XPS and STEEN Solution, are expanding the addressable market and driving revenue growth.

Abdominal

Expected Growth: 8.5%

Xvivo Perfusion AB's abdominal segment growth of 8.5% is driven by increasing demand for organ preservation and transplantation, advancements in perfusion technology, and expansion into new markets. Additionally, growing awareness of organ donation and government initiatives to increase transplantation rates contribute to the segment's growth.

Services

Expected Growth: 9.03%

Xvivo Perfusion AB's 9.03% growth is driven by increasing demand for organ preservation and transplantation, expansion into new markets, and strategic partnerships. The company's innovative perfusion technology and growing presence in the transplant market also contribute to its growth. Additionally, the rising need for organs and tissues, coupled with advancements in medical technology, further fuel the company's expansion.

7. Detailed Products

XPS

XPS is a heart preservation system designed to optimize the preservation of donor hearts for transplantation.

STEEN Solution

A specialized preservation solution used to optimize the preservation of organs for transplantation.

Xvivo Perfusion System

A system designed to optimize the preservation and transportation of organs for transplantation.

Liver Assist

A system designed to optimize the preservation and reconditioning of livers for transplantation.

Lung Assist

A system designed to optimize the preservation and reconditioning of lungs for transplantation.

8. Xvivo Perfusion AB (publ)'s Porter Forces

Forces Ranking

Threat Of Substitutes

Xvivo Perfusion AB (publ) operates in a niche market with limited substitutes, but there are some alternatives available, which reduces the threat of substitutes.

Bargaining Power Of Customers

The company's customers are primarily hospitals and research institutions, which have limited bargaining power due to the specialized nature of Xvivo's products.

Bargaining Power Of Suppliers

Xvivo Perfusion AB (publ) relies on a few key suppliers for its raw materials, which gives them some bargaining power, but the company's strong relationships with suppliers mitigate this risk.

Threat Of New Entrants

The barriers to entry in the organ preservation and perfusion market are relatively high, making it difficult for new entrants to compete with Xvivo Perfusion AB (publ)'s established products and expertise.

Intensity Of Rivalry

The organ preservation and perfusion market is moderately competitive, with a few established players, but Xvivo Perfusion AB (publ) has a strong market position and differentiated products.

9. SWOT Analysis

Strength

Weaknesses

Opportunities

Threats

10. Capital Structure

10.a. Balance Sheet

10.b. Weighted Average Cost of capital

Value
Debt Weight 1.59%
Debt Cost 3.95%
Equity Weight 98.41%
Equity Cost 13.90%
WACC 13.74%
Leverage 1.62%

11. Quality Control: Xvivo Perfusion AB (publ) passed 5 out of 9 key points

12.a Historical Valuation

12.b Price/Earnings Ratio

12.c Margin Valuation

12.d Peers Valuation

Peers Group Analysis

Stock-Card
Medistim

A-Score: 5.0/10

Value: 0.7

Growth: 6.2

Quality: 9.2

Yield: 3.8

Momentum: 8.0

Volatility: 2.0

1-Year Total Return ->

View Full Report
Stock-Card
InMode

A-Score: 4.9/10

Value: 6.6

Growth: 7.0

Quality: 9.4

Yield: 0.0

Momentum: 3.5

Volatility: 2.7

1-Year Total Return ->

View Full Report
Stock-Card
Revenio

A-Score: 4.1/10

Value: 1.1

Growth: 7.3

Quality: 8.4

Yield: 1.9

Momentum: 1.5

Volatility: 4.7

1-Year Total Return ->

View Full Report
Stock-Card
CellaVision

A-Score: 3.5/10

Value: 1.3

Growth: 6.7

Quality: 8.0

Yield: 1.9

Momentum: 0.5

Volatility: 2.3

1-Year Total Return ->

View Full Report
Stock-Card
Xvivo Perfusion

A-Score: 3.3/10

Value: 0.8

Growth: 9.8

Quality: 7.5

Yield: 0.0

Momentum: 0.5

Volatility: 1.0

1-Year Total Return ->

View Full Report
Stock-Card
ReWalk Robotics

A-Score: 3.0/10

Value: 9.8

Growth: 4.0

Quality: 4.1

Yield: 0.0

Momentum: 0.0

Volatility: 0.0

1-Year Total Return ->

View Full Report

Peers Metrics

12.e Scoring Insights

12.f DCF BETA

Parameters

Short Term Growth

Short term Time

Long-Term Growth

WACC

Target Price

185.7$

Current Price

185.7$

Potential

-0.00%

Expected Cash-Flows