Stephan Sturm, Chairman & CEO, Fresenius Group
Francesco De Meo, CEO, Fresenius Helios
Jürgen Götz, Chief Legal and Compliance Officer, and Labor Relations Director
Mats Henriksson, CEO, Fresenius Kabi
Rice Powell, CEO, Fresenius Medical Care
Ernst Wastler, CEO, Fresenius Vamed
NUMBER OF EMPLOYEES: 232,873 (total)
GLOBAL HEADQUARTERS: Bad Homburg, Germany
A joint endeavor between the University of Turin’s Torino Stem Cell Project and Fresenius has produced some astonishing results in the field of stem cell research. The first result of this collaboration isolated and characterized a human stem cell population from a liver. The liver stem cells proved to be easy to isolate, capable of multiplication without limit, and transferrable into many other cell types, making them a promising potential option for regenerative medicine.
As time went on, the partnership bore multiple discoveries. The team isolated functional pancreatic islets, which mimic the function of pancreatic cells, for diabetes treatment. They also identified stem-cell derived extracellular vessels (particles that support communication between cells) to treat kidney and liver diseases, as well as cancer. On the basis of this successful research, Fresenius established Unicyte AG as a regenerative medicine subsidiary within its Fresenius Medical Care division in May 2016.
The newly established company will pursue development projects up until the clinical human study stage, exploring stem cell-based treatments for kidney and liver diseases, diabetes, and cancer. The alliance with a global medical technology company like Fresenius—which understands the technological limitations and how to navigate a regulatory climate well—should also help to add some structure to the much-heralded, somewhat disorganized regenerative medicine field.
“The expectations for stem cell research have grown in recent years, but a rigorous scientific process is essential to developing targeted therapies while maintaining ethical standards,” Prof. Giovanni Camussi, scientific director of the Torino Stem Cell Project, commented in a company press release detailing Unicyte AB’s establishment. “To develop sound clinical applications, our research must be reproducible and scientifically verifiable.”
“The establishment of Unicyte AG is the logical step to translate the existing research collaboration on stem cells and extracellular vesicles into clinical programs,” said Florian Jehle, CEO of Unicyte and vice president of technology and innovation management at Fresenius Medical Care. “In this way, Fresenius Medical Care is bundling its regenerative medicine research for selected indications.”
ANALYST INSIGHTS: Fresenius is mostly known for its Medical Group (a leading force for people who suffer from kidney failure). What is less known is that Fresenius is also one of the largest hospital operators in Europe and has a group dedicated to drugs and clinical solutions. The recent acquisitions of Quironsalud in Spain, Akorn, and one of Merck KGaA’s biosimilar businesses will continue to expand their worldwide reach. With chairman Stephan Sturm in place for a year now, one can look forward to seeing what is next for this giant in healthcare.
—Dave Sheppard, Co-Founder and Principal, MedWorld Advisors
Fresenius Medical Care, which celebrated its 20th anniversary in autumn 2016, is a global provider of dialysis products and services for chronic kidney failure patients. Medical Care generates the most revenue of Fresenius Group’s four divisions (which also include Fresenius Kabi, Fresenius Helios, and Fresenius Vamed). While this segment does offer dialysis products as part of Fresenius Group’s medical technology portfolio, most of its revenue is generated from the services of 3,624 dialysis clinics worldwide, which treated a record 308,471 patients in 2016. That said, dialysis products were Fresenius’ only group of medical device offerings (which also include medical devices and transfusion technology, as well as infusion therapy products) to achieve a profit in FY 2016 (ended Dec. 31)—though it only climbed about 1 percent from the previous year with revenues of $3.4 billion.
Medical Care’s slight growth was, in part, stimulated by a couple of noteworthy acquisitions. In September 2016, the division purchased 85 percent of equity interest in Sandor Nephro Services, India’s second-largest dialysis service provider. (Financial terms were not disclosed.) Sandor operates over 50 dialysis centers, and the acquisition strengthened the division’s core business in one of the world’s fastest-growing economies.
The division also expanded its reach into the areas of cardiac and lung therapies by obtaining German minimally invasive lung and heart assist therapy and technology company XENIOS AG in Q4 of 2016. By entering the market for cardiac and pulmonary disease treatment, Medical Care intended to bolster its position in extracorporeal (i.e., outside the body) organ support. In bringing XENIOS on board, the division gains the novalung iLA, i-cor, and medos devices for pulmonary and cardiac assist for an extensive range of support levels on the XENIOS platform. novalung iLA therapy is an alternative to immobilizing and potentially adverse mechanical ventilation, and i-cor therapy is a less invasive heart assist therapy that is synchronized with heartbeat. These therapies enable caregivers to keep lung failure patients awake, self-determined, and mobile while preventing ventilator-associated lung injury, pneumonia, and breathing muscle damage.
“Treating heart and lung diseases with extracorporeal therapy systems is closely tied to dialysis both in technological terms and in the clinical process,” said Dr. Olaf Schermeier, management board member who directs research and development at Fresenius Medical Care. “By combining XENIOS AG’s products and the experience of Fresenius Medical Care especially in the acute area, we can put these therapies into use on a broad-scale basis and achieve further progress that will benefit patients.”
Medical Care also introduced a new generation of dialysis machines at the European Dialysis and Transplantation Association/European Renal Association conference in May 2016, unveiling the 6008 CAREsystem hemodialysis therapy system. It both minimizes the amount of risk-related handling steps and reduces complexity in therapy delivery by including an all-in-one cartridge system with completely pre-connected bloodlines for all treatment modalities. Further, the system is made even more cost-efficient and environmentally friendly by reducing the volume and weight of generated waste.
In order to better serve the dialysis care market, in April 2016 Fresenius Medical Care North America (FMCNA) rechristened its dialysis service Fresenius Kidney Care. “We created this name to better communicate our approach to helping people with kidney disease thrive and continue doing the things that matter most to them,” William Valle, executive vice president of FMCNA and president of Fresenius Kidney Care, said in the company announcement.
Fresenius Kabi, which houses the Group’s medical devices/transfusion technology and infusion therapy portfolios in addition to IV drugs and clinical nutrition products, was essentially flat in 2016 with a slight revenue gain of 57 million euros. That slight bump was not a result of medical technology sales, however. The medical devices and transfusion sector posted 2016 sales of 1 billion euros, falling 8 million euros from the year prior. Meanwhile, infusion therapy revenues dropped 5.7 percent to 861 million euros from the previous year.
Kabi gained CE mark approval for the new AmiCORE apheresis device (which obtains blood components from a donor) in 2016, and also introduced the product in Malaysia, Thailand, and Vietnam. The division also brought its CATSmart device to the United States in 2016. CATSmart provides automated auto-transfusion, making it possible to quickly administer patients’ own erythrocytes (red blood cells) for operations or should heavy blood loss occur. The technology reduces the need for donor blood transfusion.
The division also acquired a production facility and portfolio of seven IV drugs in pre-filled syringes from Becton, Dickinson and Company in 2016.
Under New Management
On June 30, 2016, Ulf Mark Schneider left Fresenius after a 14-year tenure as CEO in order to “pursue another opportunity,” according to a company release detailing the management change. Stephan Sturm, who had served as Fresenius Group’s chief financial officer since 2005, took the helm on July 1, 2016.
“On behalf of the Supervisory Board I would like to thank Ulf Mark Schneider for his extraordinary leadership and tremendous accomplishments over the past 13 years,” Gerd Krick, chairman of Fresenius Management SE’s supervisory Board, said in the release. “He has led Fresenius through a period of exciting and sustainable growth and has truly transformed the company. While we regret his departure, we wish him the very best for his future endeavors.”
Since his induction in 2005, Sturm made significant contributions to develop Fresenius into the global healthcare force it is today. He played a key role in major acquisitions and his successful financing plans facilitated the company’s strong, sustainable growth.
“I am approaching my new role with both excitement and respect,” the newly-appointed Sturm said in the company release. “The future of Fresenius continues to look bright. I am fully committed to meeting our targets, executing on our growth strategy, and contributing to affordable high-quality healthcare around the globe.”