Xvivo Perfusion is a medtech company focused on the area of transplantation. The company was a part of Vitrolife until 2012 when it was spun off and listed at First North. Marketed products focus on the area of lung transplantation, where the company's product Perfadex currently holds a dominant position in the market for cold preservation solutions used prior to lung transplants. The company has also launched a STEEN Solution and the XPS which are used for warm perfusion of lungs.
The acquisition of Vivoline in 2016 strengthens the company's position in the area of lung transplantation and also meant that the research portfolio was broadened to heart transplantation. Furthermore, Xvivo Perfusion has a research portfolio with projects within liver and heart transplantation and isolated tissue therapy. Xvivo Perfusion work with distributors on some markets, but the relatively few clinics enable the company to cost-effectively establish business relations with the customers in the most important markets. In 2016, the company had about SEK 120 million in revenues in 2016 and an EBITDA margin of 11.5 percent.
Perfadex is a preservation solution used for cold perfusion and preservation of lungs prior to transplantation. The product has been FDA approved since 2001 and the company currently holds a market share of more than 90 percent.
STEEN Solution and XPS are products used for warm perfusion of lungs, a method where the organ is perfused at body temperature prior to transplantation. The method enables an objective evaluation of the state of the organ and can thereby help decide its suitability for transplant. The process also allows the organ to recover from cooling and cleans it before insertion. Xvivo Perfusion's products only constitute a fraction of the total cost of a transplant and besides the increased supply of organs, the method also enables a less acute procedure and could thereby lower the cost per transplant.
About 5000 lung transplants are performed each year in the world, but the need is far greater. The main limiting factor is the limited supply of organs, but if warm perfusion was to be established in large scale the supply of organs could increase significantly.
Having acquired Vivoline, Xvivo Perfusion has a dominant position in the market for warm lung perfusion. The competitor TransMedics is believed to be close to a market approval for a competing product, but the clinical attractiveness is deemed to be lower since the company lacks a proprietary solution with both a machine and solution. TransMedics has a product for warm heart perfusion that has been market approved in Europe and Australia and is currently under FDA review. The sales have, however, been modest so far.
- The company has the potential to grow revenues with about 20 percent on an annual basis for a foreseeable future
- Margins are expected to expand steadily in a short-term horizon
- Research portfolio offers upside potential with low development risk
- Several potential catalysts in a short-term horizon
Xvivo Perfusion has a strong position in the market for lung transplantation. The company’s product Perfadex has a market share of about 90 percent in the market for preservation solutions used prior to lung transplants. With comprehensive documentation of the product and a steadily growing demand for lung transplants, the product is predicted to be a value driver for a foreseeable future.
The company has also launched the products XPS and STEEN Solution, which are used for warm perfusion of lungs. Warm perfusion is a method that has the potential to significantly increase the supply of organs available for transplantation. The supply of lungs is today significantly lower than the demand, causing many patients to die while waiting for an organ. Furthermore, the demand is believed to be even higher than what can be observed on the waiting lists due to the patients that are never signed up.
Leveraging its experience from the development current products, the company has also built up a strong research portfolio. The project that is closest to market launch is PrimECC, a priming solution used in heart-lung machines during open heart surgery. The number of open heart surgeries that are performed per year are estimated to be more than 500,000 in the United States and Europe alone. The company also is also developing HS1 and Heartadex, which are used for warm heart perfusion. Similarly to lungs, the demand for heart transplants far exceeds the current donor list. Given the company’s focus on the thorax region, the heart project is projected to be of high priority going forward.
We expect to see strong sales growth in the upcoming years, from what we see as low levels relative to the potential. The maintained low cost base and high scalability points to a continued margin expansion and high value creation for the shareholders, both from a short and long-term perspective.
- Perfadex holds a dominant position in the market for solutions for cold preservation of lungs, but the market share will likely decrease with time. A surge in competition could result in both lower revenue growth and margins than expected.
- The commercialisation process for new medical devices varies significantly. Soaring sales are usually held back by the time it takes for the products to become reimbursed, a process that usually takes longer than expected.
- TransMedics product for warm heart perfusion is market approved in Europe and Australia and is currently under review by the FDA. Xvivo Perfusion is further behind in development and could be faced with a situation where TransMedics already has an installed base at the larger clinics by the time they receive market approval.
- Press release Redeye: Updated analysis of Xvivo Perfusion
- Press release Förändring av antalet aktier och röster i XVIVO Perfusion
- Press release Kommuniké från årsstämma i XVIVO Perfusion AB (publ)
- Press release Flaggningsmeddelande i Xvivo Perfusion Aktiebolag
- Press release Australien och Nederländerna nya länder med XPS™
- Press release KOMMUNIKÉ FRÅN EXTRA BOLAGSSTÄMMA I XVIVO PERFUSION AKTIEBOLAG (PUBL)
- Press release Kallelse till årsstämma i XVIVO Perfusion AB (publ)
- Press release Kallelse till extra bolagsstämma i XVIVO Perfusion Aktiebolag (publ)
- Press release Styrelsen för XVIVO Perfusion beslutar om nyemission om högst ca. 181 miljoner kronor riktad till institutionella investerare
- Press release XVIVO Perfusion avser att genomföra en riktad emission av aktier