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Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"), the world's largest provider of dialysis products and services, today announced its intention to sell US$500 million of senior unsecured notes due 2021 issued by Fresenius Medical Care US Finance, Inc. and €300 million of senior unsecured notes due 2021 issued by FMC Finance VII S.A. (together with the US$ senior notes "the senior notes"). Both issuers are wholly owned subsidiaries of the company.

The senior notes will be guaranteed on a senior basis jointly and severally by the company, Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care Deutschland GmbH.

The senior notes will be offered through a private placement directed to institutional investors. There will be no public offering of the senior notes. Proceeds from the offering will be used to repay indebtedness, for acquisitions including the company's recently announced acquisition of Euromedic's dialysis service business and for general corporate purposes to support the renal products and services business.

The proposed offering will not be registered under the Securities Act of 1933. The senior notes will be offered in the United States to "qualified institutional buyers" pursuant to the exemption from registration under Rule 144A of the Securities Act, and the offering will be made in an "offshore transaction" pursuant to Regulation S under the Securities Act.

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 1.89 million individuals worldwide. Through its network of 2,716 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 210,191 patients around the globe. Fresenius Medical Care also is the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P).

For more information about Fresenius Medical Care, visit the company's website at www.fmc-ag.com.

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 VII S.A., or Fresenius Medical Care US Finance, 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 VII S.A. or Fresenius Medical Care US Finance, Inc. or Fresenius Medical Care or any member of its group. In particular, this release is not an offer of securities in the United States of America (including its territories and possessions), and securities of FMC Finance VII S.A. and Fresenius Medical Care US Finance, Inc. and Fresenius Medical Care may not be offered or sold in the United States of America absent registration under the Securities Act of 1933, as amended, (which FMC Finance VII S.A. and Fresenius Medical Care US Finance, Inc. and Fresenius Medical Care do not intend to effect) or pursuant to an applicable exemption from registration.

Fresenius Biotech today announced a Removab® distribution agreement with Swedish Orphan Biovitrum (Sobi). Under the seven-year agreement, Sobi will distribute the trifunctional antibody Removab® exclusively in 15 European countries. The markets covered by the agreement include Bulgaria, the Czech Republic, Denmark, Estonia, Finland, Iceland, Latvia, Lithuania, Norway, Poland, Romania, Slovakia, Slovenia and Sweden. Removab® was granted marketing authorization by the European Commission in April 2009 for the treatment of malignant ascites associated with cancer and so far has been launched in Germany, Austria and France.

"The agreement with Sobi is part of our strategy to complement our own marketing and sales activities with strong partnerships in additional regions. More patients now will be able to benefit from Removab®," said Christian Schetter, CEO of Fresenius Biotech. "Removab® is an innovative product that holds great value for patients with severe medical needs. We are looking forward to the Fresenius Biotech partnership and the additional growth potential Removab® will provide for our business," said Kennet Rooth, CEO of Sobi.

About Removab® (catumaxomab)
Removab® is a trademark registered by Fresenius Biotech GmbH. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites. Removab® is a trifunctional antibody licensed from TRION Pharma GmbH. The therapeutic objective of Removab® is to generate a strong immune reaction against cancer cells, resulting in their elimination.

EU approval is based on results of a large-scale international phase II/III pivotal study which demonstrated a statistically significant fourfold increase in puncture-free survival over a therapy with puncture alone. Removab® effectively destroys cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation. In addition, the results of the study indicate a positive impact on overall survival.

Removab® is approved for the treatment of malignant ascites in patients with EpCAM (Epithelial Cell Adhesion Molecule)-positive carcinomas, where standard therapy is not available or no longer feasible.

EpCAM is a tumor-associated antigen expressed on the vast majority of carcinomas (epithelial tumors). Furthermore, the majority of carcinoma-induced malignant ascites contain EpCAM-positive tumor cells. In healthy tissue, EpCAM is not accessible to binding, which makes it an attractive antigen for tumor-specific targeting.

About malignant ascites
Malignant ascites can be caused by various carcinomas. It is most common in ovarian, pancreatic and gastric cancers, with an incidence of 20 to 50 percent of all cases. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. Malignant ascites develops late in the course of cancer disease and has a strong impact on the patient's quality of life. The most common treatment of malignant ascites is puncture (paracentesis), which must be performed repeatedly and can lead to complications such as infection and fluid or protein deprivation.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2009, group sales were approximately €14.2 billion. On Sept. 30, 2010, the Fresenius Group had 136,458 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 with headquarters in Munich. For more information, please visit www.fresenius-biotech.com.

Swedish Orphan Biovitrum (Sobi) is a Stockholm-based company with an international market presence and focused on providing and developing niche-specialty pharmaceuticals for rare-disease patients with severe medical needs. Focus areas are hemophilia, inflammation/autoimmune diseases, fat malabsorption, cancer and inherited disorders. For more information, please visit www.sobi.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.

Board of Management: Dr. Ulf M. Schneider (President and CEO), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Supervisory Board: Dr. Gerd Krick (Chairman)
Registered Office: Bad Homburg, Germany/Commercial Register No. HRB 10660

Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"), the world's largest provider of dialysis products and services, today announced the pricing of US$-denominated and €-denominated senior unsecured notes (together "the senior notes") in the principal amounts of US$650 million and €300 million, respectively, both due 2021. The principal amount of the US$ senior notes was increased from the amount initially offered of US$500 million.

The coupon for the US$ senior notes will be 5.75 %. With a price of 99.06 % at issuance, the yield to maturity will be 5.875 %. The coupon for the € senior notes will be 5.25 %. The € senior notes were issued at par. Net proceeds amounting to approximately US$1,033 million from the offering will be used to repay indebtedness, for acquisitions including the company's recently announced acquisition of Euromedic's dialysis service business and for general corporate purposes to support the renal products and services business.

Michael Brosnan, chief financial officer of the company, commented: "We are pleased to have successfully completed these offerings. This means a further improvement of our solid funding structure. And it also enhances our flexibility for further pursuing our strategy of sustainable growth."

The € senior notes were offered by FMC Finance VII S.A., and the US$ senior notes were offered by Fresenius Medical Care US Finance, Inc., both wholly owned subsidiaries of the company. The senior notes will be guaranteed on a senior basis jointly and severally by the company, Fresenius Medical Care Holdings, Inc. and Fresenius Medical Care Deutschland GmbH. The senior notes were not registered under the Securities Act of 1933 as amended, but were offered to "qualified institutional buyers" in the United States pursuant to the exemption from registration provided by Rule 144A under the Securities Act and in an "offshore transaction" pursuant to Regulation S under the Securities Act. The senior notes may not be offered or sold in the United States without registration or an applicable exemption from the 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 1.89 million individuals worldwide. Through its network of 2,716 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 210,191 patients around the globe. Fresenius Medical Care also is the world's leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS/P).

For more information about Fresenius Medical Care, visit the company's website at www.fmc-ag.com.

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 VII S.A., or Fresenius Medical Care US Finance, 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 VII S.A. or Fresenius Medical Care US Finance, Inc. or Fresenius Medical Care or any member of its group. In particular, this release is not an offer of securities in the United States of America (including its territories and possessions), and securities of FMC Finance VII S.A. and Fresenius Medical Care US Finance, Inc. and Fresenius Medical Care may not be offered or sold in the United States of America absent registration under the Securities Act of 1933, as amended, (which FMC Finance VII S.A. and Fresenius Medical Care US Finance, Inc. and Fresenius Medical Care do not intend to effect) or pursuant to an applicable exemption from registration.

The change of Fresenius SE's legal form into a KGaA* in combination with the conversion of all preference shares into ordinary shares is expected to be registered with the commercial register on January 28, 2011 and will thereby become effective. The ordinary shares of Fresenius SE & Co. KGaA are scheduled to commence trading on January 31, 2011.

With registration of the resolutions of the 2010 annual general meeting, all voting ordinary shares in Fresenius SE will become voting ordinary shares in Fresenius SE & Co. KGaA. Simultaneously, all non-voting preference shares in Fresenius SE will be mandatorily converted into voting ordinary shares in Fresenius SE & Co. KGaA. The Company's share capital will remain unchanged.

Delisting of Fresenius SE shares is scheduled for January 28, 2011. Stock exchange regulations require trading to cease mid-morning until market close. All outstanding orders will expire at that time. After market close, all ordinary and preference shares of Fresenius SE are expected to be converted into ordinary shares of Fresenius SE & Co. KGaA. The listing application comprises 128,250,090 ordinary shares. 34,200,000 ordinary shares held by Else Kröner-Fresenius-Foundation will remain un-listed.

The ordinary shares of Fresenius SE & Co. KGaA will retain the ISIN DE0005785604 / Sec ID no. 578560 of the current Fresenius SE shares. The ticker symbols FRE GR (Bloomberg) and FREG.DE (Reuters) are expected to remain unchanged.

*Kommanditgesellschaft auf Aktien - partnership limited by shares

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2009, group sales were approximately €14.2 billion. On Sept. 30, 2010 the Fresenius Group had 136.458 employees worldwide.

For more information, visit the company's website at www.fresenius.com.

Neither this document nor the information contained herein constitutes an offer to sell or the solicitation of an offer to buy any securities. A public offer of shares in the Company is not intended.

This document does not constitute an offer document or an offer of transferable securities to the public in the United Kingdom to which section 85 of the Financial Services and Markets Act 2000 of the United Kingdom ("FSMA") applies and should not be considered as a recommendation that any person should subscribe for or purchase any securities as part of the Transaction. This document is being communicated only to: (i) persons who are outside the United Kingdom; (ii) persons who are members of the Company and falling within article 43 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the "Order") (iii) persons who have professional experience in matters relating to investments falling within article 19(5) of the Order; or (iv) high net worth companies, unincorporated associations and other bodies who fall within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any person who is not a Relevant Person must not act or rely on this communication or any of its contents. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. No part of this document should be published, reproduced, distributed or otherwise made available in whole or in part to any other person without the prior written consent of the Company.

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.

Board of Management: Dr. Ulf M. Schneider (President and CEO), Rainer Baule, Dr. Francesco De Meo,
Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Supervisory Board: Dr. Gerd Krick (Chairman)
Registered Office: Bad Homburg, Germany/Commercial Register No. HRB 10660

The change of Fresenius SE's legal form into a KGaA* in combination with the conversion of all preference shares into ordinary shares was registered today with the commercial register and thereby became effective. The Company operates from now on as Fresenius SE & Co. KGaA. All shareholders of the former Fresenius SE are now ordinary shareholders of Fresenius SE & Co. KGaA.

Ulf Mark Schneider, CEO of Fresenius, commented: "I am very pleased that we successfully completed the share conversion and the change of legal form. This is an important step for Fresenius and its shareholders. The conversion significantly simplifies our share structure, increases trading liquidity, and improves our financial flexibility by facilitating access to equity capital markets. The new capital structure supports our corporate strategy and its focus on sustainable and profitable growth."

The ordinary shares of Fresenius SE & Co. KGaA will commence trading on January 31, 2011 (ISIN DE0005785604 / Sec ID no. 578560; ticker symbols FRE GR (Bloomberg), FREG.DE (Reuters)). According to the index regulation of Deutsche Börse AG, the new ordinary shares will be included in the German DAX30 index (Deutscher Aktienindex).

The registration of the change of the legal form at the commercial register was finally cleared following a court settlement of pending disputes initiated by minority shareholders.

*Kommanditgesellschaft auf Aktien - partnership limited by shares

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2009, group sales were approximately €14.2 billion. On Sept. 30, 2010 the Fresenius Group had 136.458 employees worldwide.

For more information, visit the company's website at www.fresenius.com.

Neither this document nor the information contained herein constitutes an offer to sell or the solicitation of an offer to buy any securities. A public offer of shares in the Company is not intended.

This document does not constitute an offer document or an offer of transferable securities to the public in the United Kingdom to which section 85 of the Financial Services and Markets Act 2000 of the United Kingdom ("FSMA") applies and should not be considered as a recommendation that any person should subscribe for or purchase any securities as part of the Transaction. This document is being communicated only to: (i) persons who are outside the United Kingdom; (ii) persons who are members of the Company and falling within article 43 of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended) (the "Order") (iii) persons who have professional experience in matters relating to investments falling within article 19(5) of the Order; or (iv) high net worth companies, unincorporated associations and other bodies who fall within article 49(2) of the Order (all such persons together being referred to as "Relevant Persons"). Any person who is not a Relevant Person must not act or rely on this communication or any of its contents. Any investment or investment activity to which this communication relates is available only to Relevant Persons and will be engaged in only with Relevant Persons. No part of this document should be published, reproduced, distributed or otherwise made available in whole or in part to any other person without the prior written consent of the Company.

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
Supervisory Board: Dr. Gerd Krick (designated Chairman)

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

The company reached its financial targets for 2010, set new records and proposes its 14th consecutive annual dividend increase.

Full Year 2010 Summary:

 

 

Net revenue $ 12,053 million
+7 %
Operating income (EBIT) $ 1,924 million
+10 %
Net income* $ 979 million
+10 %
Earnings per share $ 3.25
+9 %
Dividend Proposal Ordinary share € 0.65
+7 %
Dividend Proposal Preference share € 0.67
+6 %

 

 


4th Quarter 2010 Summary:

 

 

 

 

 

 

Net revenue $ 3,167 million
+4 %
Operating income (EBIT) $ 539 million
+10 %
Net income* $ 271 million
+10 %
Earnings per share $ 0.90
+9 %


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 full year and fourth quarter of 2010.


*Net income attributable to Fresenius Medical Care AG & Co. KGaA

4th-Quarter 2010:

 

 


Revenue


Net revenue for the fourth quarter of 2010 increased by 4% to $3,167 million (+5% at constant currency) compared to the fourth quarter of 2009. Organic revenue growth worldwide was 4%. Dialysis services revenue grew by 6% to $2,354 million (+6% at constant currency) in the fourth quarter of 2010. Dialysis product revenue increased from $809 million in the fourth quarter of 2009 to $813 million in the fourth quarter of 2010, which corresponds to 3% growth at constant currency.

North America revenue increased by 3% to $2,072 million. Organic revenue growth was 3%. Dialysis services revenue grew by 3% to $1,862 million. Average revenue per treatment for U.S. clinics decreased to $355 in the fourth quarter of 2010 compared to $357 for the corresponding quarter in 2009. Developments were favorably impacted by reimbursement increases, while this was more than offset by reduced utilization of pharmaceuticals. Dialysis product revenue decreased by 1% to $210 million. The company's performance was impacted favorably by higher sales of machines and bloodlines. This was mainly offset by changes in the dialysis products mix and lower Medicare average selling prices for the intravenous iron product Venofer®.

International revenue increased by 7% to $1,095 million. Based on constant currency, revenue grew by 10%. Organic revenue growth was 5%. Dialysis services revenue was $492 million, an increase of 15% (+18% at constant currency). Dialysis product revenue increased by 1% to $603 million and increased by 4% at constant currency, led by higher sales of machines and dialyzers.


Earnings

Operating income (EBIT) for the fourth quarter of 2010 increased by 10% to $539 million compared to $491 million in the fourth quarter of 2009. This resulted in an operating margin of 17.0% compared to 16.2% for the corresponding quarter in 2009.

In North America, the operating margin increased from 17.7% to 17.9%. The margin development benefitted primarily from favorable pharmaceutical costs and personnel expenses, partially offset by a decrease in revenue per treatment.

In the International segment, the operating margin increased from 17.6% to 18.0% mainly due to economies of scale and favorable currency effects, partially offset by lower gross profit margins of acquired clinics.

Net interest expense for the fourth quarter of 2010 was $74 million compared to $75 million in the comparable quarter of 2009. This development was influenced favorably by decreased short-term interest rates.

Income tax expense was $169 million for the fourth quarter of 2010 compared to $145 million in the fourth quarter of 2009, reflecting effective tax rates of 36.3% and 34.9%, respectively.

Net income attributable to FMC AG & Co. KGaA for the fourth quarter of 2010 was $271 million, an increase of 10% compared to the corresponding quarter of 2009.

Earnings per share (EPS) for the fourth quarter of 2010 rose by 9% to $0.90 per ordinary share compared to $0.82 for the fourth quarter of 2009. The weighted average number of shares outstanding for the fourth quarter of 2010 was approximately 302.1 million shares compared to 299.0 million shares for the fourth quarter of 2009. The increase in shares outstanding resulted from stock option exercises in the past twelve months.


Cash Flow


In the fourth quarter of 2010, the company generated $341 million in cash from operations, representing approximately 11% of revenue. The cash flow generation was supported by increased earnings.

A total of $168 million was spent for capital expenditures, net of disposals. Free Cash Flow before acquisitions was $173 million compared to $285 million in the fourth quarter of 2009. A total of $379 million in cash was spent for acquisitions, net of divestitures. Free Cash Flow after acquisitions and divestitures and excluding short-term investments was minus $206 million compared to $206 million in the fourth quarter of 2009.




Full Year 2010:


Revenue and Earnings



Net revenue for the full year 2010 was $12,053 million, up 7% from the full year 2009. At constant currency, net revenue also rose 7%. Organic growth was 6% in 2010.

Operating income (EBIT) for the full year 2010 increased by 10% to $1,924 million compared to $1,756 million in 2009. This resulted in an operating margin of 16.0% compared to 15.6% for 2009.

Net interest expense for the full year 2010 was $280 million compared to $300 million in the corresponding period of 2009.

Income tax expense was $578 million in the full year 2010 compared to $491 million in 2009. These reflect effective tax rates of 35.2% and 33.7%, respectively.

For the full year 2010, net income attributable to FMC AG & Co. KGaA was $979 million, up 10% from 2009.

In the full year 2010, earnings per ordinary share rose 9% to $3.25. The weighted average number of shares outstanding during the full year 2010 was approximately 300.7 million.


Cash Flow


Cash from operations during 2010 was $1,368 million compared to $1,339 million for 2009, representing approximately 11% of revenue.

A total of $507 million was spent for capital expenditures, net of disposals. Free Cash Flow before acquisitions for the full year 2010 was $861 million compared to $777 million in 2009. A total of $618 million in cash was spent for acquisitions, net of divestitures. Free Cash Flow after acquisitions and divestitures and excluding short-term investments was $243 million compared to $591 million in 2009.



Please refer to the attachments for a complete overview on the fourth quarter and the full year of 2010.


Patients – Clinics – Treatments


As of Dec. 31, 2010, Fresenius Medical Care treated 214,648 patients worldwide, which represents a 10% increase compared to the previous year. North America provided dialysis treatments for 137,689 patients, an increase of 4%. Including 30 clinics managed by Fresenius Medical Care North America, the number of patients in North America was 139,327. The International segment served 76,959 patients, an increase of 21% over the prior year.

As of Dec. 31, 2010, the company operated a total of 2,757 clinics worldwide, which represents an 8% increase compared to the previous year's figure. The number of clinics is comprised of 1,823 clinics in North America (1,853 including managed clinics) and 934 clinics in the International segment, representing an increase of 2% and 21%, respectively.

During the year 2010, Fresenius Medical Care delivered approximately 31.67 million dialysis treatments worldwide. This represents an increase of 8% compared to last year. North America accounted for 20.85 million treatments, an increase of 5%; the International segment delivered 10.82 million treatments, an increase of 13%.



Employees


As of Dec. 31, 2010, Fresenius Medical Care had 73,452 employees (full-time equivalents) worldwide compared to 67,988 employees at the end of 2009. The increase of more than 5,400 employees is due to overall growth in the company's business and acquisitions.



Dividend


The company will continue to follow an earnings-driven dividend policy. For the 14th consecutive year, shareholders can expect to receive an increased annual dividend for the fiscal year 2010. At the Annual General Meeting to be held on May 12, 2011, shareholders will be asked to approve a dividend of €0.65 per ordinary share, an increase of 7% from 2009 (€0.61).



Debt/EBITDA Ratio


The ratio of debt to Earnings before Interest, Taxes, Depreciation and Amortization (EBITDA) decreased from 2.46 at the end of 2009 to 2.38 at the end of 2010.



Rating


Standard & Poor's Rating Services continued to rate the company's corporate credit as ‘BB' with a ‘positive' outlook. Moody's continued to rate the company's corporate credit as ‘Ba1' with a ‘stable' outlook, and Fitch continued to rate the company's corporate credit as ‘BB' with a ‘positive' 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.


Issuance of Senior Notes

In January 2011 Fresenius Medical Care issued $-denominated and €-denominated senior unsecured notes in the principal amounts of $650 million and €300 million, respectively, both due 2021. The coupon for the $ senior notes is 5.75%, while the coupon for the € senior notes is 5.25%. Net proceeds amounting to approximately $1,035 million from the offering will be used to repay indebtness, for acquisitions including the company's recently announced acquisition of Euromedic's dialysis service business and for general corporate purposes to support the renal products and services business.


Contract for comprehensive dialysis care reimbursement in Spain


On Jan. 19, 2011, Fresenius Medical Care announced a cooperation agreement with the public health authorities in the Murcia region of Spain for the country's first comprehensive dialysis care and performance-oriented reimbursement model. Under this agreement, Fresenius Medical Care will provide dialysis therapy to approximately 200 renal patients in the region. The contract will be effective from mid-2011. The reimbursement will be converted from a "fee-for-service" basis to an all-inclusive "bundled" rate that is tied to Fresenius Medical Care's quality performance.


Acquisition of dialysis service business from Euromedic


On Jan. 4, 2011, Fresenius Medical Care announced the signing of a purchase agreement to acquire International Dialysis Centers (IDC), Euromedic's dialysis service business. Fresenius Medical Care thus is expanding its activities in the dialysis care market, especially in Eastern Europe, where IDC treats over 8,200 hemodialysis patients. The transaction remains subject to necessary regulatory approvals by the relevant anti-trust authorities and is expected to close in the second quarter of 2011. On completion, the acquired operations will add approximately $180 million in annual revenue and are expected to be accretive to earnings in the first year after closing of the transaction. The purchase price is €485 million.



Acquisition of Gambro's Peritoneal Dialysis Business Completed



On Dec. 27, 2010, Fresenius Medical Care announced the closing of its acquisition of Gambro's worldwide peritoneal dialysis (PD) business that marked the successful completion of regulatory approvals by the relevant antitrust authorities, except Serbia where it is still pending. Fresenius Medical Care took advantage of Gambro's decision to prioritize its investments in the hemodialysis field to expand the activities in the homecare market, especially in Europe and Asia-Pacific.



Formation of renal pharmaceutical company



On Dec. 1, 2010, Fresenius Medical Care and the Swiss-based company Galenica announced the formation of a new renal pharmaceutical company named Vifor Fresenius Medical Care Renal Pharma Ltd. It is designed to develop and distribute on a worldwide basis products to treat iron deficiency anaemia and bone mineral metabolism for pre-dialysis and dialysis patients. The products will include Venofer® and Ferinject® (Injectafer®, the brand name for Ferinject® in the USA) within the field of dialysis and pre-dialysis (CKD stage III – V) as well as PA21, a novel iron-based phosphate binder. This investment allows Fresenius Medical Care to take the next major implementation step in its renal pharmaceutical strategy. Fresenius Medical Care will hold a 45% share in the new company. The transaction is subject to final antitrust approval in certain regions.



 

Outlook for 2011



For the year 2011, the company expects revenue to grow to between $12.8 billion and $13.0 billion, corresponding to a growth rate of 6% to 8%.

Net income attributable to FMC AG & Co. KGaA is expected to be between $1.035 billion and $1.055 billion, with operating margins forecast to increase by approximately 20 basis points.

For 2011, the company expects to spend around 5% of revenue on capital expenditures and approximately $1.2 billion on acquisitions. The debt/EBITDA ratio is expected to be below 2.8 by the end of 2011.

"We are very pleased to report excellent financial results for the fourth quarter and full year of 2010," said Ben Lipps, chief executive officer of Fresenius Medical Care. "With this performance, we have achieved the top end of our improved earnings guidance for 2010. In 2011, we will remain focused on our strategy to continuously improve our quality performance and operating efficiency, while maintaining vigilance regarding local health care trends. One of the trends gaining momentum around the world is the need for integrated care solutions under comprehensive payment concepts in dialysis, with the aim of reducing total health care costs while improving patient care outcomes. As a vertically integrated company, offering products and services for the entire dialysis value chain, and due to our longstanding expertise regarding clinical quality data management, we are in a unique position to meet the rising demand that such holistic therapy offers. The experience we gather in different countries by partnering with public health care providers is an asset from which we have also benefitted in the first phase of the new bundled reimbursement system in the United States. We are confident that we can meet the challenges as we look ahead."



Video Webcast


Fresenius Medical Care will hold a press conference at its headquarters in Bad Homburg, Germany, to discuss the results of the fourth quarter and the full year of 2010 on Wednesday, Feb. 23, 2011, at 10 am CET. The Company cordially invites journalists to view the live video webcast at the Company's website www.fmc-ag.com in the section "News and Press / Video service". A replay will be available shortly after the meeting.

 

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 1.89 million individuals worldwide. Through its network of 2,757 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 214,648 patients around the globe. Fresenius Medical Care also is 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.

Fresenius Medical Care
Statement of Earnings
see PDF-file

  • Sales: €16.0 billion, +13% at actual rates, +8% in constant currency
  • EBIT: €2.4 billion, +18% at actual rates, +13% in constant currency
  • Net income*: €660 million, +28% at actual rates, +23% in constant currency
     
  • Excellent sales and earnings growth in all business segments
  • "15/15" mid-term goal exceeded (€15 billion in sales, EBIT margin of 15%)
  • 15% dividend increase proposed
  • Positive outlook for 2011: Sales growth ≥7 %, net income* growth 8% to 12% (both in constant currency)
  • New mid-term stretch goal: Group net income >€1 billion in 2014

Ulf Mark Schneider, CEO of Fresenius, commented: "2010 was another outstanding year for Fresenius. Our Group achieved record sales and earnings and double-digit earnings growth in all four business segments. We even exceeded our challenging "15/15" mid-term target – Group sales of €15 billion and an EBIT margin of 15% by 2010 – despite the most severe economic slowdown in postwar history. The global demand for high-quality and innovative health care products and services continues to increase. We see further significant growth potential for all our business segments and target Group net income of more than €1 billion in 2014."

*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.

18th consecutive dividend increase proposed
Based on the excellent financial results, the Management Board will propose to the Supervisory Board a dividend increase of 15% to €0.86 per ordinary share (2009: €0.75). The total dividend distribution is expected to be €140 million.

Positive outlook for 2011
Fresenius projects sales growth of ≥7% in constant currency. Net income* is expected to increase by 8% to 12% in constant currency. This will result in a 2010/2011 compounded annual net income growth rate of 15% to 17%.

The Group plans to invest ~5% of sales in property, plant and equipment.

The net debt/EBITDA ratio is expected to stay in the range of 2.5 to 3.0.

*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.

Strong sales growth in all business segments and regions
Group sales increased by 13% at actual rates and by 8% in constant currency to €15,972 million (2009: €14,164 million). Organic sales growth was 7%. Acquisitions contributed a further 1%. Currency translation had a positive effect of 5%.

Sales growth in the business segments was as follows:

Table 1


In North America, sales grew by 9% in constant currency. Organic sales growth was 8%. In Europe, sales grew by 7% in constant currency, with organic sales growth contributing 6%. Organic sales growth reached 11% in Latin America and 7% in Asia-Pacific, where the growth rate was impacted by Fresenius Vamed's large prior-year medical supply contracts.

Table 2


Excellent earnings growth and strong margin improvement
Group EBITDA increased by 17% at actual rates and by 12% in constant currency to €3,057 million (2009: €2,616 million). Group EBIT increased by 18% at actual rates and by 13% in constant currency to €2,418 million (2009: €2,054 million). The EBIT margin increased to 15.1% (2009: 14.5%). All business segments achieved double-digit earnings growth.

Despite a substantial negative currency effect, Group net interest improved to -€566 million (2009: -€580 million).

The other financial result was -€66 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of -€98 million and the Contingent Value Rights (CVR) of €32 million. Both are non-cash items.

The Group tax rate* was 32.9% (2009: 31.4%). The tax rate in 2009 was influenced by the revaluation of a tax claim at Fresenius Medical Care.

Noncontrolling interest increased to €583 million (2009: €497 million), of which 93% was attributable to the noncontrolling interest in Fresenius Medical Care.

Group net income** increased by 28% at actual rates and by 23% in constant currency to €660 million (2009: €514 million). Earnings per ordinary share increased by 28% to €4.08. A reconciliation to adjusted earnings according to U.S.GAAP can be found on page 14 of the pdf of this press release.

Net income*** (including special items) grew to €622 million or €3.85 per ordinary 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 €758 million on property, plant and equipment (2009: €671 million) or 4.7% of sales. Acquisition spending was €644 million (2009: €260 million), mainly due to acquisitions at Fresenius Medical Care.

Strong cash flow - 12% cash flow margin
Operating cash flow increased by 23% to €1,911 million (2009: €1,553 million), mainly driven by strong earnings growth. The cash flow margin improved to 12.0% (2009: 11.0%). Net capital expenditure was €733 million (2009: €662 million). Free cash flow before acquisitions and dividends increased by 32% to €1,178 million (2009: €891 million). Free cash flow after acquisitions and dividends was €345 million (2009: €389 million).

Solid balance sheet structure - Leverage ratio significantly improved
The Fresenius Group's total assets grew by 13% to €23,577 million (Dec. 31, 2009: €20,882 million). In constant currency, the increase was 7%. Current assets increased by 20% at actual rates and by 14% in constant currency to €6,435 million (Dec. 31, 2009: €5,363 million). Non-current assets grew by 10% at actual rates and by 5% in constant currency to €17,142 million (Dec. 31, 2009: €15,519 million).

Total shareholders' equity increased by 18% at actual rates and by 11% in constant currency to €8,844 million (Dec. 31, 2009: €7,491 million). The equity ratio improved to 37.5% (Dec. 31, 2009: 35.9%).

Group debt grew by 6% at actual rates and by 1% in constant currency to €8,784 million (Dec. 31, 2009: €8,299 million). Net debt increased by 2% to €8,015 million (Dec. 31, 2009: €7,879 million). At constant currency, net debt decreased by 3%.

Due to the strong earnings growth and cash flow development, the net debt/EBITDA ratio improved to 2.62 as of December 31, 2010 (Dec. 31, 2009: 3.01). At year-end 2008, following the acquisition of APP Pharmaceuticals, the ratio was 3.64.

Number of employees increased
As of December 31, 2010, Fresenius increased the number of its employees by 5% to 137,552 (Dec. 31, 2009: 130,510).

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.

Fresenius Biotech reported sales of €26 million in 2010. The immunosuppressive agent ATG contributed €23 million and the trifunctional antibody Removab (catumaxomab) €3 million to sales.

In January 2011, Fresenius Biotech announced a Removab distribution agreement with Swedish Orphan Biovitrum (Sobi). Under the seven-year agreement, Sobi will distribute Removab exclusively in Scandinavia, the Baltics and selected Balkan countries.

So far, Removab has been marketed primarily in Germany and Austria as well as in France.

In 2010, Fresenius Biotech's EBIT was -€32 million (2009: -€44 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 December 31, 2010, Fresenius Medical Care was treating 214,648 patients in 2,757 dialysis clinics.

Table 3

 

  • Excellent sales and earnings growth continued - EBIT margin increased to 16.0%
  • Outlook 2011: Sales of US$12.8 billion to US$13 billion and net income* of US$1.035 billion to US$1.055 billion expected


Fresenius Medical Care achieved sales growth of 7% to US$12,053 million (2009: US$11,247 million). Organic growth was 6%, acquisitions contributed a further 1%. There was no meaningful currency translation effect.

Sales in dialysis care increased by 9% to US$9,070 million (2009: US$8,350 million). Dialysis product sales grew by 3% to US$2,983 million (2009: US$2,897 million).

In North America, sales increased by 7% to US$8,130 million (2009: US$7,612 million). Dialysis services revenue increased by 7% to US$7,303 million. Average revenue per treatment for U.S. clinics decreased to US$355 in Q4 2010 compared to US$357 in Q4 2009. Increases in reimbursement were more than offset by reduced utilization of pharmaceuticals. Sales in dialysis products grew by 1% to US$827 million.

Sales outside North America ("International" segment) grew by 8% to US$3,923 million (2009: US$3,635 million). Sales in dialysis care increased by 14% to US$1,767 million. Dialysis product sales grew by 4% to US$2,156 million.
EBIT increased by 10% to US$1,924 million (2009: US$1,756 million) resulting in an excellent EBIT margin of 16.0% (2009: 15.6%).

In North America, the EBIT margin increased to 17.0% (2009: 16.4%) driven by an increase in revenue per treatment as well as the effect of economies of scale. In addition, the EBIT development benefitted from favorable pharmaceutical costs.

In the International segment, the EBIT margin was 17.3% (2009: 17.5%). EBIT margin was impacted by the devaluation of the Venezuelan bolivar and related charges as well as by lower gross profit margins of acquired. This was partially offset by economies of scale and favorable currency effects.

Net income* increased by 10% to US$979 million (2009: US$891 million).

In January 2011, Fresenius Medical Care announced the signing of a purchase agreement to acquire International Dialysis Centers (IDC), Euromedic International's dialysis service business. Fresenius Medical Care is taking advantage of this opportunity to expand its activities in the dialysis care market, especially in Eastern Europe, where IDC is the market leader. IDC currently treats over 8,200 hemodialysis patients and operates a total of 70 clinics in nine countries. On completion, the acquired operations will add approximately US$180 million in annual revenue. The purchase price was €485 million. The transaction remains subject to necessary regulatory approvals by the relevant anti-trust authorities and is expected to close in the second quarter of 2011. The transaction was financed through bonds issued in February 2011.

For 2011, Fresenius Medical Care expects revenue to grow to between US$12.8 billion to US$13 billion, corresponding to a growth rate of 6% to 8%. Net income* is expected to be between US$1.035 billion and US$1.055 billion, with operating margins forecast to increase by approximately 20 basis points.

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.

Table 4

 

  • Excellent organic sales growth of 12% - EBIT margin increased to 20.1%
  • Outlook 2011: Organic sales growth of ~5% on top of challenging 2010 base - EBIT margin >19%


Sales increased by 19% to €3,672 million (2009: €3,086 million). Excellent organic growth accounted for 12%, acquisitions contributed a further 1%. Currency translation had a positive effect of 6%, mainly attributable to the strength of the currencies in North America, Brazil and China against the Euro.

In Europe, sales reached €1,702 million (2009: €1,566 million), driven by 6% organic growth. In North America, sales increased to €975 million (2009: €728 million). Organic sales growth was an exceptional 26%. In the Asia-Pacific region, Fresenius Kabi achieved organic sales growth of 13% to €593 million (2009: €482 million). Sales in Latin America and Africa increased to €402 million (2009: €310 million), organic sales growth was 10%.
EBIT grew by 21% to €737 million (2009: €607 million). The EBIT margin improved to 20.1% (2009: 19.7%), driven by the strong development in North America, where product launches and competitors' supply constraints had a positive effect. EBIT includes €20 million for investments in efficiency improvements outside North America.

Net interest improved to -€279 million (2009: -€302 million).

Net income* increased by 47% to €294 million (2009: €200 million).

APP Pharmaceuticals (APP) achieved exceptional sales growth of 29% to US$1,143 million (2009: US$889 million). Adjusted EBITDA** grew by 34% to US$464 million (2009: US$345 million). EBIT increased by 43% to US$391 million (2009: US$273 million). The EBIT margin improved to 34.2% (2009: 30.7%). In addition to the reported APP earnings, Fresenius Kabi generated EBIT contributions from imported IV drugs distributed by APP in North America.

In 2010, APP received seven product approvals from the FDA (U.S. Food and Drug Administration). In addition, Fresenius Kabi Oncology received three FDA approvals.
The APP acquisition is clearly accretive to Group EPS in 2010, in line with our original 2008 expectations.

Operating cash flow of Fresenius Kabi increased by 43% to €567 million (2009: €397 million). The cash flow margin reached 15.4% (2009: 12.9%). Cash flow before acquisitions and dividends grew by 47% to €401 million (2009: €272 million).

Fresenius Kabi achieved outstanding growth in 2010. In 2011, organic sales growth is expected to grow by approximately 5%, taking the 2010/2011 compounded annual growth rate well into the 7 to 10 % mid-term guidance range. Fresenius Kabi expects an EBIT margin of more than 19%. Net income* for 2011 is expected to surpass 2010 earnings.

For the mid-term, Fresenius Kabi maintains its targets of 7% to 10% organic sales growth and an EBIT margin in the 18% to 20% range.

Special items relating to the acquisition of APP Pharmaceuticals are included in the segment "Corporate/Other".

*Net income attributable to Fresenius Kabi AG
**Non-GAAP financial measures - Adjusted EBITDA is a defined term in the indenture governing the Contingent Value Rights (CVRs), however it is not a recognized term under GAAP.



Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. HELIOS Kliniken Group owns 63 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats more than 2 million patients per year, thereof ~600,000 inpatients, and operates a total of more than 18,500 beds.

Table 5
 

  • Strong sales and earnings growth
  • Outlook 2011: Organic sales growth of 3% to 5% and EBIT of €250 million to €260 million expected

Sales increased by 4% to €2,520 million (2009: €2,416 million). Organic growth was 5%, mainly driven by an increase in hospital admissions. The divestiture of one acute care hospital as of January 1, 2010 reduced sales growth by 1%.
EBIT grew by 15% to €235 million (2009: €205 million). The EBIT margin improved to 9.3% (2009: 8.5%). Net income* increased by 22% to €131 million (2009: €107 million).

As of January 1, 2011, HELIOS consolidates the hospital St. Marienberg in Lower Saxony. With 620 employees and 267 beds, the hospital treats about 12,000 inpatients annually. The hospital generated revenues of about €32 million in 2009.

The 2011 outlook remains positive: Fresenius Helios expects to achieve organic sales growth of 3% to 5%. EBIT is projected to increase to €250 million to €260 million.

As a new mid-term goal, Fresenius Helios targets sales of €3.5 billion by 2015, driven by both organic sales growth and acquisitions.

*Net income attributable to HELIOS Kliniken GmbH



Fresenius Vamed
Fresenius Vamed offers engineering and services for hospitals and other health care facilities.
 

Table 6

  • Strong sales and earnings growth - Order entry and order backlog with year-end record
  • Outlook 2011: Sales and EBIT growth of 5% to 10% expected

Sales increased by 15% to €713 million (2009: €618 million). Organic sales growth reached 15%. Sales in the project business rose by 16% to €487 million (2009: €420 million). Sales in the service business increased by 14% to €226 million (2009: €198 million).

EBIT increased by 14% to €41 million (2009: €36 million). The EBIT margin was 5.8%, achieving the 2009 level. Net income* rose to €30 million (2009: €27 million).

The excellent development of order intake and order backlog continued: Order intake in the project business increased by 16% to €625 million (2009: €539 million), reaching a new all-time high. In Q4 2010, order intake was €207 million. A €76 million order was received for a turn-key hospital construction in Gabon. Order backlog increased by 18% to a new year-end record of €801 million (Dec. 31, 2009: €679 million).

In 2011, Fresenius Vamed expects to achieve both sales and EBIT growth between 5% and 10%.

As a new mid-term stretch goal, Fresenius Vamed targets sales of €1 billion by 2014.

*Net income attributable to VAMED AG


Press Conference and Audio Webcast
As part of the publication of the results for fiscal year 2010, a press conference will be held at the Fresenius headquarters in Bad Homburg on February 23, 2011 at 10 a.m. CET. You are cordially invited to follow the conference in a live broadcast over the Internet at www.fresenius.com, see Press, Audio/Video Service. Following the meeting, a recording of the conference will be available as video-on-demand.

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 December 31, 2010 the Fresenius Group had 137,552 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
Supervisory Board: Dr. Gerd Krick (designated Chairman)

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

Fresenius Biotech is the first company in Germany to receive Paul-Ehrlich-Institut approval to use a polyclonal antibody in stem cell transplantations. As a result, the preparation - ATG-Fresenius S - can be used in the indication "prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults." Germany is now the fourth country to approve the preparation in this indication, after Argentina, Portugal and Thailand.

"The preparation's special mode of action and a steadily growing pool of unrelated donors make the application of ATG-Fresenius S in stem cell transplantations particularly attractive," said Dr. Christian Schetter, CEO of Fresenius Biotech. "Furthermore, there has been a considerable recent increase in the incidence of hematologic diseases which can be treated with stem cell transplantations."

In a randomized, multi-center prospective study with 201 patients, the efficacy and tolerability of ATG-Fresenius S in GVHD prophylaxis was assessed in unrelated donor stem cell transplantations. This study compared ATG-Fresenius S in combination with standard GVHD prophylaxis versus standard GVHD prophylaxis alone. Study results show that the acute and chronic GVHD rate could be reduced significantly following administration of ATG-Fresenius S. The results of this study were first presented in 2008 at the annual meeting of the American Society of Hematology and published in September 2009 in the Lancet Oncology* medical journal.

*Finke J et al., Standard graft-versus-host disease prophylaxis with or without anti-T-cell globulin in haematopoietic cell transplantation from matched unrelated donors: a randomised, open-label, multicentre phase 3 trial, Lancet Oncology 2009;10:855-864

About ATG-Fresenius S
ATG-Fresenius S is a polyclonal antibody that is used for GVHD prophylaxis shortly before stem cell transplantation is performed. The preparation's mode of action, which mainly targets activated T-cells, includes complement-mediated cytolysis and apoptotic induction of T-cells and antigen-presenting cells.
ATG-Fresenius S prevents the adhesion of T-cells to the endothelium, minimizes T-cell infiltration and blocks numerous signal transmission paths within the immune system. Furthermore, ATG-Fresenius S has a propagating effect on regulatory cells. A direct anti-tumor effect is described in various hematologic tumors.
The polyclonal antibody ATG-Fresenius S was developed in Germany over 30 years ago for the treatment and prophylaxis of acute rejection reactions in the transplantation of solid organs. ATG-Fresenius S has been approved for use in these indications worldwide in more than 45 countries.

About GVHD (graft-versus-host disease)
GVHD is a frequent complication of stem cell transplantation, which is associated with a high degree of morbidity and mortality. GVHD is an immunological reaction of the donor lymphocytes to the patient's foreign antigens. The following GVHD risk factors are known: the patient's age, the degree of kinship between the donor and the recipient, the type of preparation used for stem cell transplantation as well as the source of the graft. Several components contribute to GVHD's development, among others, tissue damage during preparations for stem cell transplantation, cytokine production and lymphocyte activation. Various immune cells (T-cells, antigen-presenting cells and natural killer cells) are involved in the GVHD mechanism. GVHD frequently causes severe organ and tissue damage, which can become chronic to some extent. GVHD can affect any organ or tissue; the skin, stomach, intestines, liver and the immune system are most frequently attacked. One of the strategies for GVHD reduction is T-cell depletion. ATG-Fresenius S depletes T-cells and consequently represents an important therapeutic advance in GVHD prevention.

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 Dec. 31, 2010, the Fresenius Group had 137,552 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.

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
Supervisory Board: Dr. Gerd Krick (designated Chairman)

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

Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"), the world's largest provider of dialysis products and services, today announced the acquisition of all assets of Hema Metrics LLC related to its Crit-Line® system. Based on its strong dialysis product business and sales organization, Fresenius Medical Care intends to establish this technology as the standard of care for fluid and anemia management in the North American market. The Crit-Line® system is an excellent fit with Fresenius Medical Care North America's 2008K, 2008K2, and 2008T hemodialysis machines.

 

The Crit-Line® system enables noninvasive optical measurement of absolute blood parameters such as percent blood volume change, absolute hematocrit level and continuous oxygen saturation. The Crit-Line® system is an effective tool for the clinician to improve fluid management with less clinical complications, such as hypotension. Improved fluid management may lead to fewer hospitalizations for renal patients. Accurate hematocrit measurement, real time, provides the clinician immediate feedback, supporting anemia management. The Crit-Line® system and its associated products are FDA 510(k) cleared, and carry the CE mark.

 

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 1.89 million individuals worldwide. Through its network of 2,757 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 214,648 patients around the globe. Fresenius Medical Care also is 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.

 

Fresenius Medical Care AG & Co. KGaA ("the company" or "Fresenius Medical Care"), the world's largest provider of dialysis products and services, announced today that the U.S. Agency for Healthcare Research and Quality (AHRQ) officially recognized the company's Patient Safety Organization (PSO). The certification by the U.S. Secretary of the Department of Health and Human Services, the first for a dialysis organization, furthers Fresenius Medical Care's mission of continuously improving patient safety and health care quality.

The purpose of a PSO is to establish a framework by which doctors and other health care providers may voluntarily report information to PSOs, on a privileged and confidential basis, to collect and analyze patient safety events. Regulations outline how the PSO may utilize data and act as a resource for health care providers to understand and minimize the risks and hazards in delivering patient care. A PSO's workforce must have expertise in analyzing patient safety events, such as the identification, analysis, prevention, and reduction or elimination of the risks and hazards associated with the delivery of patient care.

Michael Lazarus, M.D., director of the Fresenius Medical Care Patient Safety Organization: "Each of our more than 1,800 kidney dialysis clinics in the U.S. has a Quality Improvement Committee that investigates the root causes of all patient adverse events, with the objective of continuous improvement in patient safety and quality of care. Our companywide Patient Safety Organization performs a more global root cause analysis of aggregate data. We do this to maximize safe conditions in our facilities and to provide the safest dialysis treatments possible. When we find unsafe situations or processes that lead to errors, it is important to change our approach and to educate the staff as well as the patients about any unsafe conditions so that together we can eliminate them."

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 1.89 million individuals worldwide. Through its network of 2,757 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 214,648 patients around the globe. Fresenius Medical Care also is 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.

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