07.22.14
$5.41 Billion ($27.9 B total)
Key Executives:
Ulf Mark Schneider, CEO, Fresenius Group
Rice Powell, Chairman & CEO, Fresenius Medical Care AG & Co. KGaA
Mats Henriksson, CEO Fresenius Kabi
Ron Kuerbitz, CEO, Fresenius Medical Care North America
Mark Costanzo, President, Renal Therapies Group, Fresenius Medical Care North America
Bill Valle, Exec. VP, Fresenius Medical Services, Fresenius Medical Care North America
John Ducker, President and CEO, Fresenius Kabi USA
Ken Kucera, VP, Supply Chain, Region North America, Fresenius Kabi USA
Dean A. Gregory, President, Medical Devices, Region North America, Fresenius Kabi USA
No. of Employees: 178,337 (total)
Global Headquarters: Bad Homburg, Germany
According to the U.S. National Kidney Foundation, approximately 430,000 Americans are on dialysis. In addition, the Journal of the American Medical Association claims that one out of nine American adults has kidney disease—and most don’t know it.
Worldwide, there are approximately 2.5 billion people on dialysis.
These are figures about which most people are unaware.
The management of the Germany-based Fresenius Group literally has made it their business to know these numbers—and then some—given the company’s global reach in the treatment of dialysis patients.
The Fresenius Group is a global healthcare conglomerate with products and services for dialysis (which is mainly what it’s known for—particularly in the United States), the hospital and the medical care of patients at home. The parent company consists of four business segments that are responsible for their own operations worldwide: Fresenius Medical Care (dialysis products and services), Fresenius Kabi (products for the therapy and care of chronically and critically ill patients, providing intravenously administered generic drugs, infusion therapies, clinical nutrition, and medical devices for delivery of care), Fresenius Helios (operates clinics and hospitals—Germany’s largest) and Fresenius Vamed (provider of services for planning, constructing and managing healthcare facilities).
What’s the company’s reach in the dialysis market? Fresenius Medical Care treats more than 270,000 patients at its network of more than 3,200 dialysis centers worldwide—an increase of 5 percent compared with 2012.
It’s true that most of the group’s sales aren’t pure-play medical devices, but enough to account for roughly $5.4 billion of the group’s revenue for fiscal 2013 (ended Dec. 31). Medical technology-related sales includes $3.5 billion in dialysis product sales from Fresenius Medical Care, in addition to medical devices/infusion technology and infusion therapies sales from Fresenius Kabi totaling $1.9 billion. (Editors’ note: Last year’s MPO Top Company Report ranking only took into account medical product sales from Fresenius Medical Care. This year’s numbers have been adjusted to include the device/technology-related sales from Kabi as well.)
For Fresenius Medical Care, net revenue for the full year 2013 increased by 6 percent to $14.6 billion—a record high for the company. Operating income (earnings before interest and taxes) for the full year 2013 increased by 2 percent to $2.25 billion compared to $2.22 billion for full year 2012. For FY13, net income was $1.11 billion, down by 6 percent from 2012. Earnings per share decreased by 6 percent to $3.65 compared to $3.89 for 2012. With 76 percent of sales, the dialysis services sector was, by far, the largest contributor to Fresenius Medical Care’s total sales. Sales of dialysis products grew by 5 percent to $3.5 billion Accounting for 66 percent of sales, North America remained Fresenius Medical Care’s largest business region. In 2013, sales in North America grew by 6 percent to $9.6 billion compared to $9 billion in 2012.
Fresenius Medical Care claims a 34 percent share of the dialysis products market in 2013, compared with 30 percent for Baxter International (including Baxter’s recent acquisition of Gambro). In the hemodialysis market, the company boasts 37 percent share, compared to Baxter’s 17 percent and 21 percent in peritoneal products market compared to Baxter’s 71 percent. (Editor’s note: See more on Baxter International’s fiscal 2013 performance on page 54).
For 2013, Fresenius Medical Care was ranked the 60th on Forbes magazine’s list of top 100 most innovative companies (it took the 59th spot in 2012).
For Fresenius Kabi, sales increased by 10 percent to $6.9 billion in 2013. Of this, 5 percent is attributable to organic sales growth and 10 percent to acquisitions. Currency translation had a negative effect of 4 percent. Net income increased 10 percent to $670 million. Sales of infusion therapy products were approximately $1.5 billion, and medical devices/transfusion technology accounted for $1.3 billion. IV drugs and clinical nutrition sales totaled $4.2 billion.
In Europe, the division’s largest market with $2.8 billion in sales, the company recorded organic sales growth of 2 percent (in euros). Sales were affected by restrictions in the use of blood volume substitutes by the European Medicines Agency. In North America, organic sales rose 5 percent. Total North American sales were $2.1 billion, up 23 percent (in euros) most due the addition of Fenwal operation, which Fresenius Kabi acquired in December 2012. In addition, continuing supply constraints at competitors contributed to North American growth, according to Fresenius. In the Asia-Pacific region, price reductions in China had an adverse effect on sales growth. Total Asia-Pacific sales grew 7 percent to $1.3 billion.
On the new product front, Kabi’s infusion therapy segment launched the new infusion solution bottle called KabiClear, which has a greater transparency than the company’s previous plastic bottles. The company also introduced in Europe the non-PVC Freeflex+ infusion bags with a needle-free injection port, which prevents injuries from needles when preparing treatments. In the medical devices segment, the U.S. Food and Drug Administration (FDA) approved the company’s Agilia infusion pump, which already had launched in Europe. In the transfusion technology segment, the company received CE mark for the Aurora plasmapheresis system.
Plasmapheresis is a process in which the liquid in the blood, or plasma, is separated from the cells. In sick people, plasma can contain antibodies that attack the immune system. A machine removes the affected plasma and replaces it with good plasma, or a plasma substitute. This is also known as plasma exchange. The process is similar to kidney dialysis. In Taiwan and Vietnam, Fresenius Kabi rolled out the Amicus cell separator, which is used for, among other things, the collection of platelets and therapeutic plasma exchange.
For the Fresenius Group as a whole, sales were $27.9 billion (up 5 in euros). Net income was just shy of $1.5 billion, an increase of 12 percent. Organic sales growth was 4 percent. Acquisitions contributed 5 percent. Divestitures reduced sales growth by 1 percent, and currency translation had a negative effect of 3 percent.
“2013 was a year of significant achievements,” said Ulf Mark Schneider, CEO of Fresenius. “We exceeded 20 billion euros in sales and 1 billion euros in earnings for the first time. The acquisition of 40 hospitals from Rhön-Klinikum AG is a key milestone for us. Looking ahead, we see significant growth opportunities in both industrial and in developing countries. We will pursue them with ambitious strategies, operational excellence and financial prudence.”
During the year, the company had a few minor warning letter issues to resolve with the FDA.
Fresenius Kabi received a warning letter, dated August 16, from the agency related to an April 2013 inspection of the company’s Fenwal blood bag manufacturing plant in Puerto Rico. The observations primarily were related to complaint-handling procedures, labeling issues, and filing of field alerts not in accordance with FDA regulations. The letter was not issued as a result of adverse events related to patient safety. Following the inspection, Fresenius Kabi submitted a detailed remediation action plan to the agency. The company reported remedying the issue.
In March 2013 Fresenius Medical Care North America (based in Waltham, Mass.) received a warning letter from the FDA, citing the company for failing to conduct adequate design verification studies of its electron beam-sterilized polysulfone dialyzers manufactured at its facility located in Ogden, Utah, and that the process for design validation of these dialyzers has been incomplete. Fresenius Medical Care North America received FDA clearance for the product in December 2000.
In addition to corporate headquarters in Waltham, Fresenius Medical Care North America has a clinical affairs office in Nashville, Tenn., and—in addition to the Ogden facility—a manufacturing site in Concord, Calif.
Key Executives:
Ulf Mark Schneider, CEO, Fresenius Group
Rice Powell, Chairman & CEO, Fresenius Medical Care AG & Co. KGaA
Mats Henriksson, CEO Fresenius Kabi
Ron Kuerbitz, CEO, Fresenius Medical Care North America
Mark Costanzo, President, Renal Therapies Group, Fresenius Medical Care North America
Bill Valle, Exec. VP, Fresenius Medical Services, Fresenius Medical Care North America
John Ducker, President and CEO, Fresenius Kabi USA
Ken Kucera, VP, Supply Chain, Region North America, Fresenius Kabi USA
Dean A. Gregory, President, Medical Devices, Region North America, Fresenius Kabi USA
No. of Employees: 178,337 (total)
Global Headquarters: Bad Homburg, Germany
According to the U.S. National Kidney Foundation, approximately 430,000 Americans are on dialysis. In addition, the Journal of the American Medical Association claims that one out of nine American adults has kidney disease—and most don’t know it.
Worldwide, there are approximately 2.5 billion people on dialysis.
These are figures about which most people are unaware.
The management of the Germany-based Fresenius Group literally has made it their business to know these numbers—and then some—given the company’s global reach in the treatment of dialysis patients.
The Fresenius Group is a global healthcare conglomerate with products and services for dialysis (which is mainly what it’s known for—particularly in the United States), the hospital and the medical care of patients at home. The parent company consists of four business segments that are responsible for their own operations worldwide: Fresenius Medical Care (dialysis products and services), Fresenius Kabi (products for the therapy and care of chronically and critically ill patients, providing intravenously administered generic drugs, infusion therapies, clinical nutrition, and medical devices for delivery of care), Fresenius Helios (operates clinics and hospitals—Germany’s largest) and Fresenius Vamed (provider of services for planning, constructing and managing healthcare facilities).
What’s the company’s reach in the dialysis market? Fresenius Medical Care treats more than 270,000 patients at its network of more than 3,200 dialysis centers worldwide—an increase of 5 percent compared with 2012.
It’s true that most of the group’s sales aren’t pure-play medical devices, but enough to account for roughly $5.4 billion of the group’s revenue for fiscal 2013 (ended Dec. 31). Medical technology-related sales includes $3.5 billion in dialysis product sales from Fresenius Medical Care, in addition to medical devices/infusion technology and infusion therapies sales from Fresenius Kabi totaling $1.9 billion. (Editors’ note: Last year’s MPO Top Company Report ranking only took into account medical product sales from Fresenius Medical Care. This year’s numbers have been adjusted to include the device/technology-related sales from Kabi as well.)
For Fresenius Medical Care, net revenue for the full year 2013 increased by 6 percent to $14.6 billion—a record high for the company. Operating income (earnings before interest and taxes) for the full year 2013 increased by 2 percent to $2.25 billion compared to $2.22 billion for full year 2012. For FY13, net income was $1.11 billion, down by 6 percent from 2012. Earnings per share decreased by 6 percent to $3.65 compared to $3.89 for 2012. With 76 percent of sales, the dialysis services sector was, by far, the largest contributor to Fresenius Medical Care’s total sales. Sales of dialysis products grew by 5 percent to $3.5 billion Accounting for 66 percent of sales, North America remained Fresenius Medical Care’s largest business region. In 2013, sales in North America grew by 6 percent to $9.6 billion compared to $9 billion in 2012.
Fresenius Medical Care claims a 34 percent share of the dialysis products market in 2013, compared with 30 percent for Baxter International (including Baxter’s recent acquisition of Gambro). In the hemodialysis market, the company boasts 37 percent share, compared to Baxter’s 17 percent and 21 percent in peritoneal products market compared to Baxter’s 71 percent. (Editor’s note: See more on Baxter International’s fiscal 2013 performance on page 54).
For 2013, Fresenius Medical Care was ranked the 60th on Forbes magazine’s list of top 100 most innovative companies (it took the 59th spot in 2012).
For Fresenius Kabi, sales increased by 10 percent to $6.9 billion in 2013. Of this, 5 percent is attributable to organic sales growth and 10 percent to acquisitions. Currency translation had a negative effect of 4 percent. Net income increased 10 percent to $670 million. Sales of infusion therapy products were approximately $1.5 billion, and medical devices/transfusion technology accounted for $1.3 billion. IV drugs and clinical nutrition sales totaled $4.2 billion.
In Europe, the division’s largest market with $2.8 billion in sales, the company recorded organic sales growth of 2 percent (in euros). Sales were affected by restrictions in the use of blood volume substitutes by the European Medicines Agency. In North America, organic sales rose 5 percent. Total North American sales were $2.1 billion, up 23 percent (in euros) most due the addition of Fenwal operation, which Fresenius Kabi acquired in December 2012. In addition, continuing supply constraints at competitors contributed to North American growth, according to Fresenius. In the Asia-Pacific region, price reductions in China had an adverse effect on sales growth. Total Asia-Pacific sales grew 7 percent to $1.3 billion.
On the new product front, Kabi’s infusion therapy segment launched the new infusion solution bottle called KabiClear, which has a greater transparency than the company’s previous plastic bottles. The company also introduced in Europe the non-PVC Freeflex+ infusion bags with a needle-free injection port, which prevents injuries from needles when preparing treatments. In the medical devices segment, the U.S. Food and Drug Administration (FDA) approved the company’s Agilia infusion pump, which already had launched in Europe. In the transfusion technology segment, the company received CE mark for the Aurora plasmapheresis system.
Plasmapheresis is a process in which the liquid in the blood, or plasma, is separated from the cells. In sick people, plasma can contain antibodies that attack the immune system. A machine removes the affected plasma and replaces it with good plasma, or a plasma substitute. This is also known as plasma exchange. The process is similar to kidney dialysis. In Taiwan and Vietnam, Fresenius Kabi rolled out the Amicus cell separator, which is used for, among other things, the collection of platelets and therapeutic plasma exchange.
For the Fresenius Group as a whole, sales were $27.9 billion (up 5 in euros). Net income was just shy of $1.5 billion, an increase of 12 percent. Organic sales growth was 4 percent. Acquisitions contributed 5 percent. Divestitures reduced sales growth by 1 percent, and currency translation had a negative effect of 3 percent.
“2013 was a year of significant achievements,” said Ulf Mark Schneider, CEO of Fresenius. “We exceeded 20 billion euros in sales and 1 billion euros in earnings for the first time. The acquisition of 40 hospitals from Rhön-Klinikum AG is a key milestone for us. Looking ahead, we see significant growth opportunities in both industrial and in developing countries. We will pursue them with ambitious strategies, operational excellence and financial prudence.”
During the year, the company had a few minor warning letter issues to resolve with the FDA.
Fresenius Kabi received a warning letter, dated August 16, from the agency related to an April 2013 inspection of the company’s Fenwal blood bag manufacturing plant in Puerto Rico. The observations primarily were related to complaint-handling procedures, labeling issues, and filing of field alerts not in accordance with FDA regulations. The letter was not issued as a result of adverse events related to patient safety. Following the inspection, Fresenius Kabi submitted a detailed remediation action plan to the agency. The company reported remedying the issue.
In March 2013 Fresenius Medical Care North America (based in Waltham, Mass.) received a warning letter from the FDA, citing the company for failing to conduct adequate design verification studies of its electron beam-sterilized polysulfone dialyzers manufactured at its facility located in Ogden, Utah, and that the process for design validation of these dialyzers has been incomplete. Fresenius Medical Care North America received FDA clearance for the product in December 2000.
In addition to corporate headquarters in Waltham, Fresenius Medical Care North America has a clinical affairs office in Nashville, Tenn., and—in addition to the Ogden facility—a manufacturing site in Concord, Calif.