The European Commission has broadened the existing approval of Fresenius Biotech's antibody Removab® (catumaxomab) to treat malignant ascites by allowing a shorter infusion time. The infusion time for Removab® can now be halved, from six to three hours. Moreover, the approval allows marketing of follow-up results for the pivotal study in patients with malignant ascites showing that the one-year survival rate in Removab®-treated patients was more than four times higher than in the control group (11.4% Removab group vs. 2.6% control group). The summary of product characteristics for Removab® will include the overall survival data from the pivotal study with immediate effect. The broadened approval follows on the recommendation of the Committee for Medicinal Products for Human Use (CHMP), part of the European Medicines Agency (EMA). It is valid in all EU countries and also confirms the safety profile of the trifunctional antibody.
The European Commission's decision is based on the results of an analysis of pooled safety data. In clinical studies, Removab® was administered intraperitoneally as three or six-hour infusions. The safety profiles for both administrations were comparable.
Thanks to the shortened infusion time, Removab® will be easier to use in out-patient settings. "Treatment options for patients with malignant ascites must not only be effective, but also minimize the burden for the patient," said Prof. Dr. Barbara Schmalfeldt from the obstetrics and gynecology department at Technical University of Munich. "A shorter infusion time means patients spend less time at their physician's office or day clinic. The new application time for Removab® addresses this frequent patient request. It also makes applications in day-to-day practice much easier and more efficient."
# # #
About Removab® (catumaxomab)
Removab®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab® binds to Fc-gamma-receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is under further development for new indications. Catumaxomab (Removab®) is a trifunctional antibody developed by TRION Pharma GmbH.
Removab® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab®.
For more information, please visit www.removab.com.
About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21
About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.
About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011, the Fresenius Group had 142.933 employees worldwide. For more information, visit the company's website at www.fresenius.com.
Fresenius Biotech, a company of the Fresenius health care group, is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. Fresenius Biotech is a German company headquartered in Munich. For more information, please visit www.fresenius-biotech.com.
Removab® is a registered trademark of Fresenius Biotech.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius is expanding its production capacity in Southeast Asia. Fresenius Kabi, a market leader in infusion therapy and clinical nutrition, opened a new production facility in the coastal city Quy Nhon in central Vietnam today. The opening ceremony was attended by Cornelia Pieper, the Minister of State at Germany's Federal Foreign Office, along with many other high-profile guests from Germany and Vietnam. Nearly 380 employees will work at the production facility. With the new plant, Fresenius Kabi will almost double its manufacturing capacity for infusion solutions and liquid medications. Most of these products are intended for the Vietnamese market. Investment costs totaled to approximately €20 million, and construction took about two years to complete.
Ulf Mark Schneider, CEO of Fresenius, said: "Health care systems in Vietnam and other countries in Southeast Asia are developing at a rapid pace, so there is a constantly increasing demand for Fresenius Kabi products in these countries. Our new plant in Quy Nhon will help us meet this demand and allow us to make a significant contribution to high-quality, yet affordable health care in the region."
Minister of State Cornelia Pieper highlighted the plant's role in German-Vietnamese relations: "I am pleased to see that Fresenius Kabi has opened a new plant in Quy Nhon. Direct investments such as these benefit both Germany and Vietnam. And they serve to secure jobs in both countries as well. What's more, they are an important part of our two countries working more closely together."
The new plant replaces the existing Fresenius Kabi production facility in Quy Nhon. Jan Walter, managing director of Fresenius Kabi for Vietnam, Cambodia and Laos, explained: "Over the last three years, our sales in Vietnam have grown by more than 20 percent every year. The new plant in Quy Nhon will significantly increase our production capacity and has the country's most advanced production equipment for infusion solutions and liquid medications. So we are well equipped for the further growth that we expect to see at Fresenius Kabi in Vietnam over the next few years."
The new production facility covers 15,000 square meters. The manufacture of infusion solutions is already certified in line with GMP (good manufacturing practice) guidelines as set down by the World Health Organization. Most of the employees from the former plant will be taken over, and 45 new jobs are being created.
The Quy Nhon plant is run by Fresenius Kabi Bidiphar JSC, a joint venture between Fresenius Kabi and Bidiphar, a state-owned health care company based in Quy Nhon. Fresenius Kabi Bidiphar was founded on December 1, 2008, and Fresenius Kabi holds the majority of its shares and provides the management team. The joint venture is Vietnam's market leader in standard solutions and also enjoys a leading position in I.V. generic drugs. Other Fresenius Kabi products made outside Vietnam are sold through a separate entity in Ho Chi Minh City. Overall, Fresenius Kabi employs nearly 500 people in Vietnam.
Fresenius has also been providing support for the Vietnamese-German University (VGU) in Ho Chi Minh City since 2008 to foster German-Vietnamese relations. The aim of this partnership is to set up and run the Fresenius Institute of Life Sciences, an institute that offers Vietnamese medical professionals training and continuing education. Among other measures, Fresenius has committed US$1 million to the project over a period of five years.
Note to media professionals: Images and video footage related to this press release and intended for editorial use can be downloaded at:
http://www.fresenius.de/quy-nhon
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011 the Fresenius Group had 142,933 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
Fresenius Kabi is the market leader in infusion therapy and clinical nutrition in Europe and holds leading positions in important countries of Latin America and the Asia-Pacific region. Within I.V. generic drugs, Fresenius Kabi counts among the leading suppliers in the US market. Fresenius Kabi is focused on the therapy and care of critically and chronically ill patients inside and outside the hospital. Its portfolio comprises a wide range of IV drugs, infusion therapies, clinical nutrition products as well as the related medical devices. With a corporate philosophy of "caring for life," the company's goal is to improve the patient's quality of life.
Fresenius Kabi has 23,670 employees worldwide (June 30, 2011). In 2010, Fresenius Kabi's sales were €3,672 million and the company's EBIT was €737 million. Fresenius Kabi AG is a 100% subsidiary of the health care group Fresenius SE & Co. KGaA.
For more information visit the Company's website at www.fresenius-kabi.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
The Belgian Ministry of Social Affairs and Public Health has added the trifunctional antibody Removab® (catumaxomab) from Fresenius Biotech to its list of reimbursable medications. As of October 1, 2011, use of Removab® for the intraperitoneal treatment of patients with malignant ascites due to EpCAM-positive ovarian carcinoma will be reimbursed, if the eligible patients also fulfill defined additional clinical inclusion criteria. Removab® is a trifunctional monoclonal antibody approved throughout the European Union. It has already been launched in Austria, France, Germany, Scandinavia and the UK. Removab® was also approved for reimbursement in Italy in June. The positive reimbursement decision in Belgium follows a comprehensive appraisal process that thoroughly assessed both the clinical value as well as the cost-effectiveness of Removab®.
###
About Removab® (catumaxomab)
Removab®, with its trifunctional mode of action, represents the first antibody of a new generation. The therapeutic objective of Removab® is to generate a stronger immune response to cancer cells that are the main cause of ascites. Removab® binds to three different cell types simultaneously: One arm of the antibody binds to the EpCAM (epithelial cell adhesion molecule) antigen on carcinoma cells, another arm binds to CD3 on T cells. Thirdly, the intact Fc region of Removab® binds to Fc-gamma receptors on accessory cells (such as macrophages, monocytes, dendritic cells and natural killer cells). This simultaneous binding subsequently results in the mutual stimulation and activation of T cells and accessory cells, enabling the generation of a stronger immune response and destruction of cancer cells. Data from animal studies with trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab® is under further development for new indications. Catumaxomab (Removab®) is a trifunctional antibody developed by TRION Pharma GmbH.
Removab® has been approved in the European Union since April 2009 for intraperitoneal treatment of malignant ascites in patients with EpCAM-positive carcinomas where standard therapy is not available or no longer feasible.
Fresenius Biotech is responsible for the clinical development and commercialization of Removab®.
For more information, please visit www.removab.com.
About the pivotal study
The study involved 258 patients with malignant ascites due to various carcinomas. Of those, 129 suffered from ovarian cancer, while another 129 had other types of cancer. Patients received paracentesis followed by four intraperitoneal infusions of Removab®, or paracentesis alone (control group). Details of the study results are published by Heiss et al, Int J Cancer 2010;127:2209–21
About epithelial cell-adhesion molecule (EpCAM)
EpCAM is a tumor-associated antigen expressed on the vast majority of epithelial tumors. EpCAM is expressed on tumor cells in the ascites fluid of patients with EpCAM-positive tumors.
About malignant ascites
Malignant ascites can be caused by various kinds of tumors. The peritoneal spread of tumor cells leads to an accumulation of fluid in the peritoneal cavity and is associated with an unfavorable prognosis for the patient. The most common method of treatment is paracentesis, which generally must be repeated at intervals of one to two weeks and can lead to complications such as infections or elevated losses of fluids and proteins. Removab® destroys the peritoneal cancer cells and thus directly attacks the cause of malignant ascites.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011, the Fresenius Group had 142.933 employees worldwide. For more information, visit the company's website at www.fresenius.com.
Fresenius Biotech, a company of the Fresenius health care group, is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. Fresenius Biotech is a German company headquartered in Munich. For more information, please visit www.fresenius-biotech.com.
Removab® is a registered trademark of Fresenius Biotech.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Bad Homburg, Germany – Fresenius Medical Care AG & Co. KGaA ("the Company" or "Fresenius Medical Care"; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services, today announced the pricing of euro-denominated floating-rate senior notes ("Senior Notes"). The aggregate principal amount to be issued is €100 million.
The Senior Notes will be issued at par and carry interest of three-months Euribor plus 350 basispoints. The Senior Notes will mature on October 15, 2016. The Senior Notes will be offered by FMC Finance VIII S.A., a wholly-owned subsidiary of the Company, in a private placement outside the United States to non-US institutional investors only. The Senior Notes will be guaranteed jointly and severally by the Company and its subsidiaries, Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care Deutschland GmbH. The Company expects to close and settle the offering on October 17, 2011, subject to customary closing conditions.
Michael Brosnan, chief financial officer of the Company, commented: "We will take advantage of the additional market demand in excess of our recently issued fixed rate senior notes. We will use the proceeds to repay debt and for other corporate purposes".
The Senior Notes will not be registered under the Securities Act of 1933 as amended, and will be offered in exempted "offshore transactions" pursuant to Regulation S under the Securities Act. The Senior Notes may not be offered or sold in the U.S. unless registered under the Securities Act or pursuant to an applicable exemption from registration requirements.
Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2 million individuals worldwide. Through its network of 2,838 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 225,909 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.
For more information about Fresenius Medical Care, visit the company's website at www.fmc-ag.com.
Legal Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
This release does not constitute or form part of, and should not be construed as, an offer or invitation to subscribe for, underwrite or otherwise acquire, any securities of FMC Finance VIII S.A., or Fresenius Medical Care US Finance II, Inc. or Fresenius Medical Care or any present or future member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of FMC Finance VIII S.A. or Fresenius Medical Care US Finance II, Inc. or Fresenius Medical Care or any member of its group. In particular, this release is not an offer to sell or a solicitation of offers to purchase any securities in the United States of America (including its territories and possessions), and securities of FMC Finance VIII S.A. and Fresenius Medical Care US Finance II, Inc. and Fresenius Medical Care may not be offered or sold in the United States of America or to United States persons absent registration under the Securities Act of 1933, as amended, (which FMC Finance VIII S.A. and Fresenius Medical Care US Finance II, Inc. and Fresenius Medical Care do not intend to effect) or pursuant to an applicable exemption from registration.
The information contained in this release may not be issued or distributed in or into Canada, Australia or Japan and does not constitute an offer to sell nor an invitation to subscribe for, underwrite or otherwise acquire securities in Canada, Australia or Japan.
HELIOS Kliniken GmbH, a subsidiary of Fresenius, expands its presence in the German hospital market. The company has agreed to acquire 94.7% of the share capital in Damp Group.
Damp operates seven acute care hospitals and four post acute care hospitals with a total of 4,112 beds (thereof 2,649 in acute care) and is among the ten largest private hospital operators in Germany. In addition, Damp operates eight outpatient medical care centers, two nursing care facilities with a total of 606 beds and a wellness resort. The company has 5,971 full-time employees.
The acquisition of Damp is an excellent geographic fit with the HELIOS hospital network in the north and northeast of Germany. The Damp hospitals enjoy a strong local market position and offer considerable growth potential. Both Damp and HELIOS were co-founders of the leading German medical quality initiative "Initiative Qualitätsmedizin".
In 2010, Damp achieved sales of €487 million and operating profit (EBIT) of €21 million. Acute care contributed 73% to total sales, post acute care 20%. The parties agreed not to disclose the purchase price.
Ulf Mark Schneider, CEO of Fresenius, commented: "We take advantage of this excellent opportunity to acquire a well-positioned and profitable company to strengthen HELIOS' presence in the German hospital market. As demonstrated with the acquisition of the privately-owned hospital operator Humaine in 2006, we will integrate Damp into the HELIOS network and achieve margin improvements in line with our established financial targets. Our focus on acquiring public-sector hospitals remains unchanged as we see a rebound in the German hospital privatization market."
The acquisition is still subject to the approval of local and antitrust authorities. Due to the geographic proximity of the HELIOS hospital Schwerin, HELIOS has to divest the Damp hospital Wismar (505 beds, sales of approximately €60 million) to secure regulatory clearance of the transaction.
HELIOS anticipates to close the transaction in the first half of 2012. The acquisition is expected to be accretive to Fresenius Group's earnings per share in 2013.
The acquisition will be financed from cash flow and debt. For 2012, the Damp acquisition and Fresenius Medical Care's recently announced acquisitions are not expected to lead to Group leverage above the target range of 2.5 to 3.0 net debt/EBITDA.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011 the Fresenius Group had 142,933 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
HELIOS Kliniken Group has 64 clinics, of which 44 are acute hospitals and 20 are post acute care clinics. With five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal, HELIOS maintains a leading market position in the privatization of hospitals of this size in Germany. In addition, HELIOS has 30 medical care centers. HELIOS is one of the largest providers of inpatient and outpatient care in Germany and treats more than 2 million patients per year, thereof approximately 650,000 are inpatients. HELIOS has about 19,000 beds and 34,000 employees. Sales in 2010 were €2.5 billion.
For more information visit the Company's website at www.helios-kliniken.de.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
Aufsichtsratsvorsitzender: Dr. Gerd Krick
Fresenius has established a sponsored Level I American Depositary Receipt (ADR) program in the United States. An ADR is a receipt that is issued by a depositary bank representing ownership of a company's underlying shares. ADRs are created to facilitate U.S. investors to hold shares in non-U.S. companies and trade them in the same way as U.S. securities.
Fresenius ADRs will now be available for trading in the U.S. over-the-counter (OTC) market. Eight ADRs represent one Fresenius share. The ticker symbol is FSNUY. Deutsche Bank acts as depositary bank for the ADR program.
Ulf Mark Schneider, CEO of Fresenius, commented: "Fresenius is a global health care group with a strong presence in the United States. For many years, U.S. investors have been an important part of our shareholder base. The new ADR program now allows them to invest in Fresenius in their home market, providing them with the opportunity to participate in our Group's future development."
The Fresenius share is listed on the German stock exchanges in Frankfurt, Düsseldorf and Munich and is a member of the DAX30 stock index.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011 the Fresenius Group had 142,933 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
HELIOS Kliniken GmbH, a subsidiary of Fresenius, strengthens its position as the largest private hospital operator in the state of North-Rhine Westphalia, Germany. The company has agreed to acquire 51 percent of the share capital in Katholisches Klinikum Duisburg hospital (KKD). The remaining share capital will be held by local institutions related to the Catholic Church.
KKD operates a maximum care hospital with four locations in Duisburg and a total of 1,034 beds as well as a rehabilitation clinic with 220 beds. KKD also operates two nursing care facilities. In 2010, KKD's hospitals provided inpatient care for about 30,000 patients (thereof 26,500 in acute care). KKD has about 2,200 employees and achieved 2010 sales of approximately € 134 million.
HELIOS will establish two new hospital buildings to consolidate KKD's acute care operations into two locations. The total investments by the company will be approximately € 176 million, over five years.
HELIOS already operates 10 acute care hospitals in North-Rhine Westphalia including maximum care facilities in Wuppertal and Krefeld.
The acquisition is still subject to the approval of antitrust authorities and is expected to close in the first quarter of 2012. The parties agreed not to disclose the purchase price.
The acquisition will be financed from cash flow. For 2012, the KKD as well as the Damp acquisition and Fresenius Medical Care's recently announced acquisitions are not expected to lead to Group leverage above the target range of 2.5 to 3.0 net debt/EBITDA.
"The acquisition of this maximum care hospital is another important step in the growth strategy for our hospital business. It provides an excellent geographic and medical fit to the HELIOS network. The HELIOS success story at the nearby Krefeld hospital shows that we can successfully develop maximum care facilities under private ownership", said Dr. Ulf M. Schneider, CEO of Fresenius.
Fresenius Helios is one of the largest private hospital operators in Germany. HELIOS owns 64 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats more than 2 million patients per year, thereof approximately 650,000 inpatients, and operates about 19,000 beds.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On June 30, 2011 the Fresenius Group had 142,933 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
HELIOS Kliniken Group has 64 clinics, of which 44 are acute hospitals and 20 are post acute care clinics. With five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal, HELIOS maintains a leading market position in the privatization of hospitals of this size in Germany. In addition, HELIOS has 30 medical care centers. HELIOS is one of the largest providers of inpatient and outpatient care in Germany and treats more than 2 million patients per year, thereof approximately 650,000 are inpatients. HELIOS has about 19,000 beds and 34,000 employees. Sales in 2010 were €2.5 billion.
For more information visit the Company's website at www.helios-kliniken.de.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g., changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Summary Third Quarter 2011
Net revenue $3,242 million +6%
Operating income
(EBIT) $534 million +8%
Net income* $279 million +13%
Earnings per share $0.92 +12%
Summary First Nine Months 2011
Net revenue $9,473 million +7%
Operating income
(EBIT) $1,488 million +7%
Net income* $761 million +8%
Earnings per share $2.51 +7%
*Net income attributable to Fresenius Medical Care AG & Co. KGaA
Bad Homburg, Germany – Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services, today announced its results for the third quarter and first nine months of 2011.
Third Quarter 2011
Revenue
Net revenue for the third quarter of 2011 increased by 6% to $3,242 million (+4% at constant currency) compared to the third quarter of 2010. Organic revenue growth worldwide was 1%. Dialysis services revenue grew by 4% to $2,425 million (+3% at constant currency) and dialysis product revenue increased by 11% to $817 million (+5% at constant currency).
North America revenue for the third quarter of 2011 decreased by 1% to $2,050 million including the impact of the new Medicare end-stage renal disease prospective payment system in the United States. Dialysis services revenue decreased by 1% to $1,846 million with a same market growth of 3%. Average revenue per treatment for U.S. clinics decreased to $345 in the third quarter of 2011 compared to $359 for the corresponding quarter in 2010 reflecting the implementation of the new prospective payment system. Dialysis product revenue decreased by 2% to $204 million, as increased sales of hemodialysis products could not entirely offset lower pricing of renal drugs.
International revenue increased by 20% to $1,187 million (+13% at constant currency). Organic revenue growth was 6%. Dialysis services revenue increased by 26% to $579 million (+20% at constant currency). Dialysis product revenue increased by 15% to $608 million and increased by 7% at constant currency, mainly driven by higher sales of peritoneal dialysis products, dialyzers, solutions, concentrates and dialysis machines.
Earnings
Operating income (EBIT) for the third quarter of 2011 increased by 8% to $534 million compared to $493 million in the third quarter of 2010. This resulted in an operating margin of 16.5% for the third quarter of 2011 compared to 16.1% for the corresponding quarter in 2010.
In North America, the operating margin increased from 18.1% in the third quarter of 2010 to 18.3% in the third quarter of 2011. This increase was mainly favorably influenced by the development of pharmaceutical costs and a positive impact from a royalty adjustment for Venofer®. Average costs per treatment for U.S. clinics decreased to $279 in the third quarter of 2011 compared to $289 for the corresponding quarter in 2010.
In the International segment, the operating margin increased from 15.8% to 17.3% mainly due to lower manufacturing costs, favorable exchange rate effects and business growth in Asia-Pacific.
Net interest expense for the third quarter of 2011 was $68 million compared to $70 million in the third quarter of 2010. This development was mainly attributable to increased interest income related to the loan to Renal Advantage Partners.
Income tax expense was $163 million for the third quarter of 2011 compared to $153 million in the third quarter of 2010. The effective tax rate decreased to 35.0% from 36.2%.
Net income attributable to Fresenius Medical Care AG & Co. KGaA for the third quarter of 2011 was $279 million, an increase of 13% compared to the corresponding quarter of 2010.
Earnings per share (EPS) for the third quarter of 2011 rose by 12% to $0.92 per ordinary share compared to $0.82 for the third quarter of 2010. The weighted average number of shares outstanding for the third quarter of 2011 was approximately 303.2 million shares compared to 301.2 million shares for the third quarter of 2010. The increase in shares outstanding resulted from stock option exercises in the past 12 months.
Cash Flow
In the third quarter of 2011, the company generated $463 million in cash from operations, representing approximately 14% of revenue. The cash flow generation was supported by a favorable development of days sales outstanding (DSO) and increased earnings.
A total of $150 million in cash was spent for capital expenditures, net of disposals. Free cash flow before acquisitions was $313 million compared to $263 million in the third quarter of 2010. A total of $49 million in cash was spent for acquisitions, net of divestitures. Free cash flow after acquisitions and divestitures was $264 million compared to $176 million in the third quarter of 2010.
Nine Months Ended September 30, 2011
Revenue and Earnings
Net revenue for the first nine months of 2011 increased by 7% to $9,473 million (+4% at constant currency) compared to the first nine months of 2010. Organic revenue growth was 2% in the first nine months of 2011.
Operating income (EBIT) for the first nine months of 2011 increased by 7% to $1,488 million compared to $1,385 million in the first nine months of 2010, resulting in an operating margin of 15.7% compared to 15.6% for the first nine months of 2010.
Net interest expense for the first nine months of 2011 was $214 million compared to $206 million in the same period of 2010.
Income tax expense for the first nine months of 2011 was $436 million compared to $410 million in the same period in 2010, reflecting effective tax rates of 34.2% and 34.7%, respectively.
For the first nine months of 2011, net income attributable to Fresenius Medical Care AG & Co. KGaA was $761 million, up by 8% from the first nine months of 2010.
In the first nine months of 2011, earnings per ordinary share rose by 7% to $2.51. The weighted average number of shares outstanding during the first nine months of 2011 was approximately 302.7 million.
Cash Flow
Cash from operations during the first nine months of 2011 was $950 million compared to $1,027 million for the same period in 2010, representing approximately 10% of revenue.
A total of $380 million in cash was spent for capital expenditures, net of disposals. Free cash flow before acquisitions for the first nine months of 2011 was $570 million compared to $688 million in the same period in 2010. A total of $1,171 million in cash was spent for acquisitions, net of divestitures. Free cash flow after acquisitions and divestitures was -$601 million compared to $318 million in the first nine months of last year.
Please refer to the attachments for a complete overview on the third quarter and first nine months of 2011.
Patients – Clinics – Treatments
As of September 30, 2011, Fresenius Medical Care treated 228,239 patients worldwide, which represents a 9% increase compared to the previous year's figure. North America provided dialysis treatments for 140,422 patients, an increase of 3%. Including 22 clinics managed by Fresenius Medical Care North America, the number of patients in North America was 141,809. The International segment provided dialysis treatments to 87,817 patients, an increase of 18% over the prior year's figure.
As of September 30, 2011, the company operated a total of 2,874 clinics worldwide, which represents a 6% increase compared to the previous year's figure. The number of clinics is comprised of 1,838 clinics in North America (1,860 including managed clinics), and 1,036 clinics in the International segment, representing an increase of 2% and 14%, respectively.
During the first nine months of 2011, Fresenius Medical Care delivered approximately 25.46 million dialysis treatments worldwide. This represents an increase of 9% compared to last year's figure. North America accounted for 16.11 million treatments, an increase of 4%. The International segment delivered 9.35 million treatments, an increase of 18%.
Employees
As of September 30, 2011, Fresenius Medical Care had 77,825 employees (full-time equivalents) worldwide compared to 73,452 employees at the end of 2010. This increase of more than 4,300 employees is due to overall growth in the company's business and acquisitions.
Debt/EBITDA Ratio
The ratio of debt to Earnings before interest, taxes, depreciation and amortization (EBITDA) increased from 2.37 at the end of the third quarter of 2010 to 2.55 at the end of the third quarter of 2011. The debt/EBITDA ratio at the end of the second quarter 2011 was 2.77.
Rating
Standard & Poor's Ratings Services rates the company's corporate credit as ‘BB' with a ‘positive' outlook. Moody's rates the company's corporate credit as ‘Ba1' with a ‘stable' outlook, and Fitch rates the company's corporate credit as ‘BB+' with a ‘stable' outlook. For further information on Fresenius Medical Care's credit ratings, maturity profiles and credit instruments, please visit our website at www.fmc-ag.com / Investor Relations / Credit Relations.
Acquisition of American Access Care Completed
The American Accesss Care (AAC) acquisition was closed effective October 1, 2011. AAC operates 28 freestanding out-patient centers primarily dedicated to serving vascular access needs of dialysis patients. The acquired operations will add approximately $175 million in annual revenue and are expected to be accretive to earnings in the first year after closing of the transaction.
Vifor Fresenius Medical Care Renal Pharma Ltd. Formation Completed
After the recent clearance by the European Union antitrust commissions the formation of Vifor Fresenius Medical Care Renal Pharma Ltd. has been completed globally on November 1, 2011.
Acquisition of Liberty Dialysis Holdings, Inc.
The acquisition of Liberty Dialysis Holdings, Inc. is on schedule and is expected to close in the first quarter of 2012.
Issuance of floating rate senior notes
In October 2011, Fresenius Medical Care issued €-denominated floating rate senior notes in the principal amount of €100 million, due 2016. The coupon is equal to the three-month Euribor rate plus 350 basis points.
Issuance of senior notes
In September 2011, Fresenius Medical Care issued $-denominated and €-denominated senior unsecured notes in the principal amounts of $400 million and €400 million, respectively, both due 2018. The coupon for the $ senior notes is 6.5%, and the coupon for the € senior notes is also 6.5%. Proceeds amounting to $949 million from the offering were used for acquisitions, to refinance indebtness and for general corporate purposes.
Sales and earnings outlook for 2011 confirmed
For the full year 2011, the company confirms its sales and earnings outlook.
Revenue is expected to grow to above $13 billion.
Net income attributable to Fresenius Medical Care AG & Co. KGaA is expected to be between $1.070 billion and $1.090 billion.
For 2011, the company expects to spend around 5% of revenue on capital expenditures and approximately $1.9 billion on acquisitions. The debt/EBITDA ratio is expected to be below 3.0 by the end of 2011.
"With our execution to date we continue to achieve a strong operational performance with a strong focus on quality and expense control. We expect further earnings momentum in the fourth quarter this year, supported by the recent acquisitions and cost management. We are fully on track to achieve our full year guidance", said Ben Lipps, chief executive officer of Fresenius Medical Care. "We are particularly pleased with our success globally, given a persistently challenging business environment and the ongoing implementation of the new prospective payment system in the U.S. Our emphasis on innovation and patient care continues to serve us well."
Conference Call
Fresenius Medical Care will hold a conference call to discuss the results of the third quarter and first nine months of 2011 on Wednesday, November 2, 2011, at 3:30 p.m. CET / 10:30 a.m. EDT. The company invites investors to listen to the live webcast of the call at the company's website www.fmc-ag.com in the "Investor Relations" section. A replay will be available shortly after the call.
Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2 million individuals worldwide. Through its network of 2,874 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 228,239 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.
For more information about Fresenius Medical Care, visit the Company's website at www.fmc-ag.com.
Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.
Q1-3 2011:
- Sales: €12.1 billion, +2% at actual rates, +5% in constant currency
- EBIT: €1,862 million, +5% at actual rates, +9% in constant currency
- Net income*: €565 million, +14% at actual rates, +17% in constant currency
- Fresenius improves 2011 earnings1 outlook of 15% to 18% constant currency growth to upper half of range
- Group earnings at single-quarter all-time high – €202 million net income1, record 16% EBIT margin
- Fresenius Medical Care with further margin improvement and strong earnings growth
- Fresenius Kabi with 3% organic sales growth over outstanding Q3 2010
- Fresenius Helios continues expansion in the German hospital market - raises earnings guidance
- Fresenius Vamed with excellent order intake of €171 million in Q3
*Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.
Ulf Mark Schneider, CEO of Fresenius, commented: "Fresenius had a very strong third quarter. With a Group EBIT margin of 16% and net income of €202 million we reached new all-time highs. We improve our 2011 earnings outlook and expect to achieve the upper half of our 15% to 18% target range. HELIOS' acquisitions of the private hospital chain Damp and the maximum care hospital in Duisburg significantly strengthen our presence in the German hospital market. This marks a further step in our growth strategy, which combines organic growth and acquisitions."
Group outlook 2011
Fresenius improves its 2011 earnings guidance and expects to achieve constant currency net income* growth in the upper half of the 15% to 18% range. Based on the sales growth of the first three quarters, Fresenius now expects to increase sales by c. 6% in constant currency.
The Group plans to invest approximately 5% of sales in property, plant and equipment.
In 2011, the net debt/EBITDA ratio is expected to stay in the range of 2.5 to 3.0. For calendar year 2012, Fresenius Medical Care's and Fresenius Helios' recently announced entirely debt and cash flow-financed acquisitions are not expected to cause Group leverage to exceed that target range.
*Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.
Sales growth of 5% in constant currency
Group sales increased by 2% (5% in constant currency) to €12,089 million (Q1-3 2010: €11,821 million). Organic sales growth was 4%. Acquisitions contributed a further 1%. Currency translation had a negative effect of 3%. This is mainly attributable to the average USD/EUR rate in Q1-3 2011 decreasing 8% compared to Q1-3 2010.
Sales growth in the business segments was as follows:
Organic sales growth was 1% in North America, due to the implementation of the new Medicare end-stage renal disease prospective payment system as well as lower pricing of renal drugs. In Europe organic sales growth was 3%. Prior-year sales in Europe were positively influenced by Fresenius Vamed's large medical supply contract to the Ukraine. Organic sales growth reached 12% in Africa and 15% in both Latin America and Asia-Pacific.
Continued strong earnings growth
Group EBITDA grew by 4% (8% in constant currency) to €2,344 million (Q1-3 2010: €2,244 million). Group EBIT increased by 5% (9% in constant currency) to €1,862 million (Q1-3 2010: €1,776 million). The EBIT margin improved by 40 basis points to 15.4% (Q1-3 2010: 15.0%). In Q3 2011, the Group achieved a strong EBIT margin of 16.0%.
Group net interest was -€401 million (Q1-3 2010: -€424 million).
The other financial result was -€100 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of -€105 million and the Contingent Value Rights (CVR) of €5 million. Both are non-cash items. As the CVR were delisted in March 2011, the effect relates solely to Q1 2011. As the MEB came to maturity on August 14, 2011, no further effect will occur after Q3 2011. Upon maturity, the bonds were mandatorily exchanged into ordinary shares of Fresenius Medical Care AG & Co. KGaA. Fresenius' shareholding now amounts to 30.3% of Fresenius Medical Care's ordinary share capital.
The Group tax rate* was 30.9% (Q1-3 2010: 32.2%).
Noncontrolling interest increased to €445 million (Q1-3 2010: €421 million), of which 93% was attributable to the noncontrolling interest in Fresenius Medical Care.
Group net income** increased by 14% (17% in constant currency) to €565 million (Q1-3 2010: €495 million). In Q3 2011, Group net income** reached a new all-time high of €202 million (Q3 2010: €193 million). In Q1-3 2011, earnings per share increased by 13% to €3.47.
A reconciliation to adjusted earnings according to U.S. GAAP can be found on page 15 of this Press Release.
Group net income*** (including special items) reached €485 million or €2.98 per share.
*Adjusted for the effect of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) related to the acquisition of APP Pharmaceuticals
**Net income attributable to Fresenius SE & Co. KGaA; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) related to the acquisition of APP Pharmaceuticals. Both are non-cash items.
***Net income attributable to Fresenius SE & Co. KGaA
Continued investments in growth
The Fresenius Group spent €480 million on property, plant and equipment (Q1-3 2010: €494 million). Acquisition spending was €908 million (Q1-3 2010: €223 million), mainly due to the acquisitions of Euromedic's dialysis service business as well as a minority stake in Renal Advantage, Inc., both by Fresenius Medical Care.
Cash flow development
Operating cash flow was €1,156 million (Q1-3 2010: €1,346 million). The strong earnings growth was offset by increased working capital requirements due to business expansion. The cash flow margin was 9.6% (Q1-3 2010: 11.4%). Net capital expenditure was €475 million (Q1-3 2010: €491 million). Free cash flow before acquisitions and dividends was €681 million (Q1-3 2010: €855 million). Free cash flow after acquisitions and dividends was -€538 million (Q1-3 2010*: €348 million).
*Does not include a €100 million cash out for a short-term bank deposit by Fresenius Medical Care in 2010.
Solid balance sheet structure
The Group's total assets increased by 5% to €24,707 million (Dec. 31, 2010: €23,577 million). In constant currency, the increase was 6%. Current assets increased by 6% (8% in constant currency) to €6,836 million (Dec. 31, 2010: €6,435 million). Non-current assets increased by 4% (5% in constant currency) to €17,871 million (Dec. 31, 2010: €17,142 million).
Due to the maturity of the MEB, total shareholders' equity increased by 14% (16% in constant currency) to €10,049 million (Dec. 31, 2010: €8,844 million). The equity ratio improved to 40.7% (Dec. 31, 2010: 37.5%).
Group debt grew by 5% (also 5% in constant currency) to €9,181 million (Dec. 31, 2010: €8,784 million) primarily resulting from acquisition financing. Net debt increased by 6% (7% in constant currency) to €8,527 million (Dec. 31, 2010: €8,015 million).
The net debt/EBITDA ratio increased slightly to 2.70 as of September 30, 2011 (Dec. 31, 2010: 2.62).
Number of employees increased
As of September 30, 2011, Fresenius Group increased the number of its employees by 6% to 145,118 (Dec. 31, 2010: 137,552).
Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.
Sales increased by 13% to €22.4 million (Q1-3 2010: €19.9 million). ATG sales increased by 11% to €19.7 million and Removab sales by 29% to €2.7 million.
In 2011, Removab was launched in the Benelux countries, Italy, Scandinavia and the UK. The trifunctional antibody has already been marketed in Austria and France since 2010 and was launched in Germany in 2009.
Fresenius Biotech's EBIT was -€19 million (Q1-3 2010: -€21 million). For 2011, Fresenius Biotech expects an EBIT of about -€30 million.
Business Segments
Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of September 30, 2011, Fresenius Medical Care was treating 228,239 patients in 2,874 dialysis clinics.
- Strong earnings growth and further margin improvement
- 2011 outlook confirmed
Fresenius Medical Care achieved sales growth of 7% to US$9,473 million (Q1-3 2010: US$8,886 million). Organic sales growth was 2%, acquisitions contributed a further 2%.
Sales in dialysis services increased by 5% to US$7,072 million (Q1-3 2010: US$6,716 million). Dialysis product sales grew by 11% to US$2,401 million (Q1-3 2010: US$2,170 million).
In North America sales were US$6,055 million (Q1-3 2010: US$6,058 million). Dialysis services sales were US$5,456 million (Q1-3 2010: US$5,441 million). Average sales per treatment for U.S. clinics was US$345 in Q3 2011 compared to US$359 in Q3 2010. This is a result of the implementation of the Medicare end-stage renal disease prospective payment system. Dialysis product sales decreased to US$599 million (Q1-3 2010: US$617 million) as increased sales of hemodialysis and peritoneal dialysis products could not entirely offset lower pricing of renal drugs.
Sales outside North America ("International" segment) grew by 20% to US$3,405 million (Q1-3 2010: US$2,828 million). Sales in dialysis services increased by 27% to US$1,616 million. Dialysis product sales increased by 15% to US$1,789 million.
EBIT increased by 7% to US$1,488 million (Q1-3 2010: US$1,385 million). The EBIT margin improved by 10 basis points to 15.7% (Q1-3 2010: 15.6%).
In North America the EBIT margin increased to 17.1% (Q1-3 2010: 16.7%). This increase was mainly favorably influenced by the development of pharmaceutical costs.
In the International segment the EBIT margin remained at the previous year's level of 17.0%.
Net income* increased by 8% to US$761 million (Q1-3 2010: US$707 million).
Fresenius Medical Care confirms the outlook for 2011. The company projects sales of more than US$13 billion. Net income* is expected between US$1,070 million and US$1,090 million.
For further information, please see Fresenius Medical Care's Press Release at www.fmc-ag.com.
*Net income attributable to Fresenius Medical Care AG & Co. KGaA
Fresenius Kabi
Fresenius Kabi offers infusion therapies, intravenously administered generic drugs and clinical nutrition for seriously and chronically ill patients in the hospital and outpatient environments. The company is also a leading supplier of medical devices and transfusion technology products.
- Organic sales growth of 9%, strong EBIT margin of 20.8%
- 3% organic sales growth over outstanding Q3 2010
- 2011 outlook improved – Organic sales growth between 8% and 8.5%, EBIT margin ≥20%
Fresenius Kabi reported excellent financial results. In Q3 2011, Fresenius Kabi achieved 3% organic sales growth over previous year's outstanding quarter. Q3 2010 results were driven by significant supply constraints in the injectable drug market in North America.
In Q1-3 2011, sales increased by 8% to €2,950 million (Q1-3 2010: €2,723 million). Organic sales growth was 9%, acquisitions contributed 1%. Currency translation had a negative effect of 2%. This is mainly attributable to the U.S. dollar weakness against the euro.
In Europe sales grew by 8% to €1,360 million (Q1-3 2010: €1,264 million), driven by organic sales growth of 6%. In North America sales were impacted by currency translation and increased by 3% to €755 million (Q1-3 2010: €730 million). Organic sales growth was 10%. In Asia-Pacific sales increased by 17% to €511 million (Q1-3 2010: €436 million), with excellent organic sales growth of 18%. Sales in Latin America and Africa increased by 11% to €324 million (Q1-3 2010: €293 million), with organic sales growth contributing 11%.
EBIT grew by 10% to €613 million (Q1-3 2010: €557 million). The EBIT margin improved to 20.8% (Q1-3 2010: 20.5%). EBIT growth was mainly attributable to the strong development in North America and the emerging markets.
Net interest remained at the previous year's level of -€212 million.
Net income* increased by 19% to €271 million (Q1-3 2010: €228 million).
Fresenius Kabi's operating cash flow was €350 million (Q1-3 2010: €378 million), resulting in a cash flow margin of 11.9% (Q1-3 2010: 13.9%). Given increased capital expenditures, cash flow before acquisitions and dividends was €234 million (Q1-3 2010: €272 million).
In September 2011, Fresenius Kabi expanded its production capacity in Asia and opened a new production facility in Vietnam. With the new plant Fresenius Kabi almost doubles its local manufacturing capacity for infusion solutions and liquid medications. Most of these products are intended for the Vietnamese market. Total investment amounted to approximately €20 million.
Fresenius Kabi improves its outlook for 2011. The company now forecasts organic sales growth between 8% and 8.5%. Previously, Fresenius Kabi projected organic sales growth of ~8%. The EBIT margin is now expected to be ≥20%. The previous guidance was ~20%.
Fresenius Kabi plans to host a Capital Market Day on June 12, 2012 in Bad Homburg providing an update on the strategy and growth prospects of the company.
Special items relating to the acquisition of APP Pharmaceuticals are included in the segment "Corporate/Other".
*Net income attributable to Fresenius Kabi AG
Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. HELIOS owns 64 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats more than 2 million patients per year, thereof approximately 650,000 inpatients, and operates about 19,000 beds.
- Organic sales growth of 4%, EBIT margin increase to 10%
- Expansion in the German hospital market – acquisition of Damp Group and Katholisches Klinikum Duisburg hospital
- 2011 EBIT outlook raised to €260 million to €270 million
Sales increased by 6% to €1,950 million (Q1-3 2010: €1,840 million), mainly driven by solid organic sales growth of 4%. Acquisitions contributed 2% to overall sales growth.
EBIT grew by 13% to €195 million (Q1-3 2010: €172 million). The EBIT margin improved by 70 basis points to 10.0% (Q1-3 2010: 9.3%).
Net income* increased by 19% to €117 million (Q1-3 2010: €98 million).
The established clinics increased sales by 4% to €1,916 million. EBIT improved by 16% to €199 million. The EBIT margin was 10.4%. The acquired clinics (consolidation < 1 year) achieved sales of €34 million and an EBIT of -€4 million. Restructuring of these hospitals is fully on track.
On October 12, HELIOS announced that it agreed to acquire 94.7% of the share capital in Damp Group. The acquisition of Damp is an excellent geographic fit with the HELIOS hospital network in the north and northeast of Germany.
Damp operates seven acute care hospitals and four post-acute care hospitals with a total of 4,112 beds (thereof 2,649 in acute care). In addition, Damp operates eight outpatient medical care centers, two nursing care facilities and a wellness resort. In 2010, Damp achieved sales of €487 million and operating profit (EBIT) of €21 million.
The acquisition is still subject to the approval of local and antitrust authorities. Due to the geographic proximity of the HELIOS hospital Schwerin, HELIOS has to divest the Damp hospital Wismar (505 beds, sales of approximately €60 million) to secure regulatory clearance of the transaction. HELIOS anticipates closing the transaction in the first half of 2012.
On October 31, HELIOS announced that it agreed to acquire 51% of the share capital in Katholisches Klinikum Duisburg hospital (KKD), North-Rhine Westphalia. KKD provides an excellent geographic and medical fit to the HELIOS network, as HELIOS already operates ten acute care hospitals in North-Rhine Westphalia including maximum care hospitals in Wuppertal and Krefeld.
KKD operates a maximum care hospital with four locations in Duisburg and a total of 1,034 beds as well as a rehabilitation clinic with 220 beds. KKD also operates two nursing care facilities. In 2010, KKD's hospitals achieved sales of approximately €134 million. HELIOS will consolidate the acute care hospitals into two locations and build two new hospitals. The total investments will be approximately €176 million, over five years. The acquisition is still subject to the approval of antitrust authorities. Closing of the transaction is anticipated in the first quarter of 2012.
The recent acquisitions are significant achievements in Fresenius Helios' growth strategy. As a result, a new mid-term sales guidance for Fresenius Helios will be provided in spring 2012. Currently, the company targets sales of €3.5 billion by 2015.
Fresenius Helios raises its earnings outlook and now projects EBIT of €260 million to €270 million. Previously, the company expected to reach an EBIT of ~€260 million. Fresenius Helios fully confirms its sales outlook and projects organic sales growth of 3% to 5%.
*Net income attributable to HELIOS Kliniken GmbH
Fresenius Vamed
Fresenius Vamed offers engineering and services for hospitals and other health care facilities.
- Sales and EBIT in line with expectations
- Excellent order intake of €171 million in Q3
- 2011 outlook confirmed
Fresenius Vamed's sales reached €480 million (Q1-3 2010: €517 million). Sales in the project business were €311 million (Q1-3 2010: €351 million). Prior-year sales included a substantial medical supply contract with the Ukraine. In addition, current sales were impacted by the unrest in the Middle East / North Africa region. Sales in the service business increased by 2% to €169 million (Q1-3 2010: €166 million).
EBIT was €22 million (Q1-3 2010: €24 million). The EBIT margin of 4.6% was at previous year's level. Net income* was €17 million (Q1-3 2010: €18 million).
Order backlog was €775 million as of September 30, 2011 (Dec. 31, 2010: €801 million). In Q3 2011, Fresenius Vamed achieved an excellent order intake of €171 million. New orders include turnkey contracts for the construction of a general hospital in Sochi, Russia (total order volume €98 million) as well as for the reconstruction of a general hospital in Hesse, Germany (total order volume €42 million). The order intake in Q1-3 2011 was €335 million (Q1-3 2010: €418 million).
Fresenius Vamed confirms the 2011 outlook. The company projects sales and EBIT growth of 0% to 5%.
*Net income attributable to VAMED AG
Analyst Meeting and Audio Webcast
As part of the publication of the results for Q1-3 2011, a conference call will be held on November 2, 2011 at 2.00 p.m. CET (9.00 a.m. EDT). You are cordially invited to follow the conference call in a live broadcast via the Internet at www.fresenius.com, Investor Relations, Presentations. Following the call, a replay of the conference call will be available on our website.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2010, Group sales were approximately €16.0 billion. On September 30, 2011 the Fresenius Group had 145,118 employees worldwide.
For more information visit the company's website at www.fresenius.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius SE & Co. KGaA
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11852
Chairman of the Supervisory Board: Dr. Gerd Krick
General Partner: Fresenius Management SE
Registered Office: Bad Homburg, Germany
Commercial Register: Amtsgericht Bad Homburg, HRB 11673
Management Board: Dr. Ulf M. Schneider (Chairman), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Chairman of the Supervisory Board: Dr. Gerd Krick
Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"; Frankfurt Stock Exchange: FME / New York Stock Exchange: FMS), the world's largest provider of dialysis products and services, today introduced the 2008K@home, a hemodialysis system for use at the patient's home, at the American Society of Nephrology's Kidney Week 2011 meeting in Philadelphia, USA. The 2008K@home machine is built on the 2008® series hemodialysis machine platform that has delivered superior hemodialysis therapy for over 30 years. This machine combines safety, efficacy and reliability with a simple user-interface that incorporates an on-screen tutorial to walk the user through set-up, treatment, and disconnection from therapy. Earlier this year, the U.S. Food and Drug Administration (FDA) cleared the 2008K@home machine for use.
"With the growing interest in home therapies in the U.S., the 2008K@home machine provides another option for delivering hemodialysis to patients who want the freedom associated with being at home," said Maureen Lyden-Green, Vice President for Home Therapies at Fresenius Medical Care North America. "The 2008K@home provides patients with a smaller version of the in-center machine and allows flexibility to deliver a customized physician's dialysis prescription for each patient, meeting the patient's medical needs and suiting their lifestyle," continued Chief Medical and Regulatory Affairs Officer Dr. Jose Diaz-Buxo.
Fresenius Medical Care is the world's largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 2 million individuals worldwide. Through its network of 2,874 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 228,239 patients around the globe. Fresenius Medical Care is also the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products.
For more information about Fresenius Medical Care, visit the Company's website at www.fmc-ag.com.
Disclaimer
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG & Co. KGaA's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG & Co. KGaA does not undertake any responsibility to update the forward-looking statements in this release.