Fresenius Biotech has dispatched the marketing authorization application for the trifunctional antibody Removab (INN: catumaxomab) in patients with malignant ascites to the European Medicines Agency (EMEA) as planned. The company applies for the EU authorization of Removab for the intraperitoneal treatment of malignant ascites in patients with epithelial cancers where no standard therapy is available or no longer feasible. The results of the phase II/III pivotal study announced in December 2006 as well as in March and July 2007 are an essential part of the marketing authorization application. In addition to the clinical results, the application contains preclinical data as well as production and product quality information. The scientific assessment of the marketing authorization application will start in early 2008 after the completion of the validation by EMEA.

Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius SE, commented: "The marketing authorization application for our Removab antibody is an important milestone for Fresenius Biotech. The results of the phase II/III pivotal study show clear benefits for patients treated with Removab. We believe that Removab could become a new therapy option for malignant ascites. We are encouraged to continue our Removab clinical trial program and will focus on applications in solid tumors."

Trifunctional Antibodies
Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and direct these to the tumor cells by a targeted approach. Trifunctional antibodies therefore are very effective in destroying cancer cells and show a therapeutic effect even at very low doses. They are being developed by TRION Pharma GmbH.

Mode of action of trifunctional antibody removab (catumaxomab)
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. removab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T-cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of intact trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T-cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Apart from removab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development.

Fresenius Biotech is a company within the Fresenius health care group and is focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. For further information please visit www.fresenius-biotech.com.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2006, group sales were approx. € 10.8 billion. On September 30, 2007 the Fresenius Group had 110,379 employees worldwide.

TRION Pharma is a biopharmaceutical company that develops and produces trifunctional antibodies based on a globally patented technology platform together with Fresenius Biotech in Munich. For further information please visit www.trionpharma.de.

Fresenius AG today provided details regarding its contemplated bond issue announced in October 2005. The Company intends to issue € 1.0 billion in Senior Notes (the "Senior Notes") through its wholly-owned subsidiary Fresenius Finance B.V. (the "Issuer"), subject to market conditions. The net proceeds from the Senior Notes offering (the "Senior Notes Offering"), along with the proceeds from our recent capital increase, finance the acquisition of HELIOS Kliniken GmbH and the proposed repurchase of the Issuer's outstanding € 300 million 7.750 % Series A Senior Notes due 2009, callable in 2006, by way of a cash tender (the "Tender Offer") and will be used for general corporate purposes.

Fresenius AG expects to complete the Senior Notes Offering before the end of January 2006.

The proposed Senior Notes Offering will not be registered under the Securities Act of 1933, but will be offered in the United States pursuant to an exemption from registration under Rule 144A, as well as outside the United States under Regulation S.

Credit Suisse First Boston (Europe) Limited and Morgan Stanley & Co. International Limited have been mandated as Joint Book-Running Lead Managers and Dresdner Bank AG London Branch as Joint Lead Manager of the proposed Senior Notes Offering.

The Tender Offer is subject to the terms described in the tender offer memorandum dated January 3, 2006.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2004, sales were € 7.27 billion. On December 31, 2004 the Fresenius Group had 68,494 employees worldwide.


This announcement is for distribution only to persons who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the "Financial Promotion Order"), (ii) are persons falling within Article 43 of the Financial Promotion Order (iii) are persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc") of the Financial Promotion Order, (iv) are outside the United Kingdom, or (v) are persons to whom this announcement can otherwise be lawfully communicated or caused to be communicated (all such persons together being referred to as "relevant persons"). This announcement is directed only at relevant persons and must not be acted on or relied on by persons who are not relevant persons. Any investment or investment activity to which this announcement relates is available only to relevant persons and will be engaged in only with relevant persons.

This announcement is not an offer for sale of securities in the United States. Securities may not be sold in the United States absent registration or an exemption from registration under the U.S. Securities Act of 1933, as amended (re "Securities Act"). The Senior Notes referred to herein have not been and will not be registered under the Securities Act and Fresenius does not intend to register any portion of the offering in the United States or to conduct a public offering of securities in the United States. Copies of this announcement are not being made and may not be distributed or sent into the United States, Canada, Japan or Australia. It may be unlawful to distribute this announcement in certain other jurisdictions. The information in this announcement does not constitute an offer of securities for sale in Canada, Japan or Australia.

This announcement or any related documents are not being distributed in the context of a public offer in France within the meaning of Article L. 411-1 of the French Monetary and Financial Code (Code monétaire et financier), and thus neither this announcement nor any prospectus has been or will be submitted to the Autorité des Marchés Financiers for approval in France and accordingly may not and will not be distributed to the public in France. The offer of the Senior Notes is not being made and will not be made to the public in France except to (i) qualified investors (investisseurs qualifiés) and/or a restricted group of investors (cercle restreint d'investisseurs), in each case, acting for their own account, all as defined in, and in accordance with, Articles L. 411-1, L. 411-2, D. 411-1 and D. 411-2 of the French Monetary and Financial Code and/or (ii) persons providing portfolio management investment services acting for third parties.

This announcement does not constitute an offer to sell notes or a solicitation to buy notes in Germany. There will be no public offering of notes in Germany. Any offering of notes can only be made in accordance with the German Securities Prospectus Act (Wertpapierprospektgesetz, WpPG). No selling document pursuant to the German Securities Prospectus Act has been or will be published in relation to the Senior Notes. Therefore, this announcement and any other offering material in relation to the Senior Notes is directed only at persons who are "qualified investors" within the meaning of sec. 2 No. 6 of the German Securities Prospectus Act.

This announcement is an advertisement and is not a prospectus for the purposes of EU Directive 2003/71/EC (the "Directive"). This announcement and the offering of Senior Notes when made are only addressed to and directed at persons in member states of the European Economic Area who are "qualified investors" within the meaning of Article 2(1)(e) of the Directive.

Fresenius Biotech today announced that Enzon Pharmaceuticals, Inc. has decided not to continue the clinical development of the immunosuppressant ATG-Fresenius S for the U.S. market. Enzon terminated the agreement as a consequence of ongoing efforts to redirect its research and development investments to projects strategically aligned with its current business objectives, including an increasing focus on cancer and adjacent therapeutic areas. Fresenius is currently in negotiations with potential partners to continue the ongoing clinical development. During a transition period, Enzon will continue to fulfill its clinical and regulatory obligations.

ATG-Fresenius S is an immunosuppressive agent made from a polyclonal antibody and is used to suppress organ rejection following transplantation. Fresenius currently markets the drug in more than 60 countries and it generated about € 17 million in sales in 2004.

Fresenius Biotech GmbH is a company of the Fresenius Health Care Group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine.

Fresenius AG today announced that Standard & Poor's and Moody's will change their credit ratings for the Company by one notch. Standard & Poor's plans to lower its rating from "BB+" to "BB" with a negative outlook upon completion of the Renal Care Group acquisition by Fresenius Medical Care. Moody's lowered its rating from "Ba1" to "Ba2" in anticipation of the Renal Care Group acquisition. The outlook is stable.

Stephan Sturm, Chief Financial Officer, commented: "This is an expected downgrade given the decision to fully debt-finance the acquisition of Renal Care Group. On the other hand, the acquisition sustainably strengthens Fresenius Medical Care's position in the global dialysis market. We have a proven ability to considerably reduce debt from solid cash flows and are therefore confident to meet our financial goals."

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.

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

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

• 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:

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.

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.

• 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.

• 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.


 

• 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.
 

• 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 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.

Q1 2011:

• Sales: €4.0 billion, +9% at actual rates, +7% in constant currency
• EBIT: €575 million, +15% at actual rates, +13% in constant currency
• Net income*: €170 million, +43% at actual rates, +39% in constant currency

• Group raises 2011 outlook for sales and earnings* growth
• Fresenius Medical Care and Fresenius Kabi raise 2011 outlook
• Fresenius Helios – narrows earnings guidance to upper half of range
• Fresenius Vamed fully confirms guidance

Ulf Mark Schneider, CEO of Fresenius, commented: „After record results in 2010, we are pleased to report strong sales and earnings growth for the first quarter of 2011. All of our business segments had an excellent start. We have seen particularly strong growth at Fresenius Kabi in North America, where we continue to benefit from successful product launches and supply constraints in the injectable drugs market. Based on Fresenius Kabi's prospects, Fresenius Medical Care's successful implementation of the ESRD prospective payment system in the United States and Fresenius Helios' strong earnings development, we raise our Group's sales and earnings guidance for 2011."

For 2011, Fresenius Group now expects sales growth of 7% to 8% and net income growth of 12% to 16%, both in constant currency. Previously, the company expected sales growth of ≥7% and net income growth of 8% to 12%, both in constant currency.

The Group plans to invest approximately 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 organic sales growth
Group sales increased by 9% (7% in constant currency) to €3,962 million (Q1 2010: €3,643 million). Organic sales growth was 6%. Acquisitions contributed a further 1%. Currency translation had a positive effect of 2%.

Sales growth in the business segments was as follows:



Organic sales growth was 5% in North America and 2% in Europe. Prior year sales in Europe were positively influenced by Fresenius Vamed's large medical supply contract to the Ukraine. Organic sales growth reached 13% in Latin America, 18% in Asia-Pacific and 28% in Africa.



Excellent earnings growth
Group EBITDA increased by 13% (12% in constant currency) to €737 million (Q1 2010: €650 million). Group EBIT increased by 15% (13% in constant currency) to €575 million (Q1 2010: €501 million). The EBIT margin increased to 14.5% (Q1 2010: 13.8%).

Group net interest improved to -€135 million (Q1 2010: -€143 million).

The other financial result was -€62 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of -€67 million and the Contingent Value Rights (CVR) of €5 million. Both are non-cash items. The CVR were delisted in March 2011. The MEB will come to maturity in August 2011.

The Group tax rate* was 30.7% (Q1 2010: 33.2%). The prior year was impacted by non-tax deductible charges related to the devaluation of the Venezuelan Bolivar.
Noncontrolling interest increased to €135 million (Q1 2010: €120 million), of which 93% was attributable to the noncontrolling interest in Fresenius Medical Care.

Group net income** increased by 43% (39% in constant currency) to €170 million (Q1 2010: €119 million). Earnings per ordinary share increased by 41% to €1.05. A reconciliation to adjusted earnings according to U.S. GAAP can be found on page 14 of the pdf of this Press Release.

Group net income*** (including special items) reached €128 million or €0.79 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 €136 million on property, plant and equipment (Q1 2010: €124 million). Acquisition spending was €311 million (Q1 2010: €81 million), mainly due to acquisitions at Fresenius Medical Care.

Cash flow development
Operating cash flow was €278 million (Q1 2010: €438 million). Strong earnings growth was more than offset by increased DSOs (days sales outstanding), primarily related to the introduction of the new Medicare end-stage renal disease prospective payment system in the U.S. dialysis service business, and raised inventory levels. The cash flow margin was 7.0% (Q1 2010: 12.0%). Net capital expenditure increased to €147 million (Q1 2010: €130 million). Free cash flow before acquisitions and dividends was €131 million (Q1 2010: €308 million). Free cash flow after acquisitions and dividends was -€133 million (Q1 2010: €218 million).

Solid balance sheet structure
The Group's total assets were €23,572 million (Dec. 31, 2010: €23,577 million). In constant currency, the increase was 4%. Current assets increased by 6% (9% in constant currency) to €6,808 million (Dec. 31, 2010: €6,435 million). Non-current assets were €16,764 million (Dec. 31, 20010: €17,142 million). In constant currency, the increase was 2%.

Total shareholders' equity decreased by 1% to €8,788 million (Dec. 31, 2010: €8,844 million). In constant currency, the increase was 4%. The equity ratio was 37.3% (Dec. 31, 2010: 37.5%).

Group debt remained almost unchanged (4% growth in constant currency) at €8,823 million (Dec. 31, 2010: €8,784 million). Net debt decreased by 1% to €7,929 million (Dec. 31, 2010: €8,015 million). In constant currency, net debt increased by 3%.

The net debt/EBITDA ratio improved to 2.52 as of March 31, 2011 (Dec. 31, 2010: 2.62).

Number of employees increased
As of March 31, 2011, Fresenius Group increased the number of its employees by 2% to 140,111 (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.

Fresenius Biotech sales increased by 16% to €7.3 million in the first quarter 2011 (Q1 2010: € 6.3 million). The immunosuppressive agent ATG contributed €6.5 million and the trifunctional antibody Removab (catumaxomab) €0.8 million to sales.

In March 2011, Fresenius Biotech received Paul-Ehrlich-Institut approval to use a polyclonal antibody in stem cell transplantations. As a result, ATG-Fresenius S now can be used in the indication "prophylaxis of graft-versus-host disease (GVHD) for unrelated stem cell transplant donors in adults".

In addition, reimbursement negotiations for Removab in Italy were successfully concluded.

In the first quarter of 2011, Fresenius Biotech's EBIT was -€7 million (Q1 2010: -€8 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 March 31, 2011, Fresenius Medical Care was treating 216,942 patients in 2,769 dialysis clinics.

• Strong start into the year – despite the impact of the new Medicare prospective payment system in the U.S.
• Outlook 2011 raised: Sales above US$13 billion and net income* of US$1,070 million to US$1,090 million

Fresenius Medical Care achieved sales growth of 5% to US$3,036 million (Q1 2010: US$2,882 million). Organic growth was 3%, acquisitions contributed a further 2%.

Sales in dialysis service increased by 5% to US$2,285 million (Q1 2010: US$2,171 million). Dialysis product sales grew by 6% to US$751 million (Q1 2010: US$711 million).

In North America, sales increased by 1% to US$1,977 million (Q1 2010: US$1,960 million). Dialysis services sales increased by 1% to US$1,782 million. Average sales per treatment for U.S. clinics decreased to US$348 in the first quarter of 2011 compared to US$355 for the corresponding quarter in 2010 as a result of the implementation of the new Medicare end-stage renal disease prospective payment system. Dialysis product sales were US$195 million (Q1 2010: US$200 million).

Sales outside North America ("International" segment) grew by 14% to US$1,055 million (Q1 2010: US$922 million). Sales in dialysis services increased by 23% to US$503 million. Dialysis product sales increased by 8% to US$552 million, mainly driven by higher sales of peritoneal dialysis products, dialyzers, bloodlines and products for acute care treatments.

EBIT increased by 5% to US$445 million (Q1 2010: US$425 million) resulting in an EBIT margin of 14.7% (Q1 2010: 14.8%).

In North America, the EBIT margin increased to 15.8% (Q1 2010: 15.7%). The favorable development of pharmaceutical costs was largely offset by the effects of the implementation of the new Medicare end-stage renal disease prospective payment system in the U.S.

In the International segment, the EBIT margin was 16.2% (Q1 2010: 16.4%).

Net income* increased by 5% to US$221 million (Q1 2010: US$211 million).

On March 8, 2011, Fresenius Medical Care 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.

Based on the strong financial results in the first quarter of 2011 and the elimination of the "transition adjustment" imposed on dialysis facilities (as part of the new Medicare end-stage renal disease prospective payment system) in the U.S., the company raises its outlook for the full year 2011. Fresenius Medical Care now projects sales of more than US$13 billion. Previously, the company expected sales between US$12.8 billion and US$13.0 billion. Net income* is now expected between US$1,070 million and US$1,090 million. Previously, Fresenius Medical Care expected net income between US$1,035 million and US$1,055 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.

• Excellent first quarter – Outstanding organic sales growth of 16%
• Outlook 2011 raised: Organic sales growth >5% on top of challenging 2010 base - EBIT margin between 19% and 20%

Fresenius Kabi had a very successful start into 2011. Strong sales and earnings growth was mainly driven by continued high demand in North America. Product launches as well as continued supply constraints in the injectable drug market which had expanded in March 2010 had a positive effect. Moreover, Fresenius Kabi achieved excellent organic sales growth of 10% outside of North America.

Sales increased by 20% to €960 million (Q1 2010: €800 million). Organic growth was excellent and increased by 16%. Acquisitions contributed 1%. Currency translation had a positive effect of 3%, mainly attributable to the strength of the currencies in China, Brazil and Australia against the Euro.

In Europe, sales grew by 10% to €449 million (Q1 2010: €409 million), driven by strong organic growth of 8%. In North America, sales increased by 42% to €254 million (Q1 2010: €179 million). Organic sales growth was an exceptional 39%. In Asia-Pacific, Fresenius Kabi achieved sales growth of 22% to €156 million (Q1 2010: €128 million), driven by organic sales growth of 16%. Sales in Latin America and Africa increased by 20% to €101 million (Q1 2010: €84 million) with organic sales growth contributing 13%.

EBIT grew by 36% to €197 million (Q1 2010: €145 million). The EBIT margin improved significantly to 20.5% (Q1 2010: 18.1%), mainly driven by the strong development in North America.

Net interest improved to -€68 million (Q1 2010: -€74 million).

Net income* increased by 89% to €87 million (Q1 2010: €46 million).

Fresenius Kabi's operating cash flow was €67 million (Q1 2010: €74 million). The cash flow margin was 7.0% (Q1 2010: 9.3%). Cash flow before acquisitions and dividends was €22 million (Q1 2010: €42 million).

Fresenius Kabi raises its outlook for 2011 and forecasts organic sales growth of >5%. Previously, organic sales growth of approximately 5% was expected. Furthermore, Fresenius Kabi expects an EBIT margin of 19% to 20% with net income* surpassing 2010 earnings. Previously, an EBIT margin of >19% was projected.

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 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.

• Strong organic sales growth of 5% continued
• Excellent earnings growth – EBIT margin improved to 9.0%
• Outlook 2011 – EBIT guidance narrowed to upper half of range

Sales increased by 7% to €648 million (Q1 2010: €608 million). Organic sales growth was 5%, mainly driven by an increase in hospital admissions. Acquisitions contributed 2% to overall sales growth, due to the consolidation of St. Marienberg hospital in Helmstedt / Lower Saxony with 267 beds.

EBIT grew by 12% to €58 million (Q1 2010: €52 million). The EBIT margin improved to 9.0% (Q1 2010: 8.6%).

The established clinics increased sales by 5% to €639 million. EBIT improved by 12% to €58 million. The EBIT margin was at 9.1%.

Net income* increased by 18% to €33 million (Q1 2010: €28 million).

In the first quarter of 2011, Fresenius Helios announced the acquisition of the municipal hospital in Rottweil, southwestern Germany. The 264-bed acute care clinic has approximately 600 employees and generated sales of approximately €31 million in 2009. The acquisition has been already approved by the German anti-trust authorities. Helios expects to close the transaction in the third quarter of 2011.

Fresenius Helios fully confirms its outlook for 2011. The company expects organic sales growth of 3% to 5%. EBIT is projected to increase to €250 million to €260 million; the company expects to achieve the upper half of this range.

*Net income attributable to HELIOS Kliniken GmbH


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

• €842 million order backlog – new all-time high
• Sales and earnings fully in line with our expectations
• Outlook 2011 fully confirmed

Fresenius Vamed's sales reached €140 million (Q1 2010: €156 million). Sales in the project business were €84 million (Q1 2010: €102 million). Prior year sales included a substantial medical supply contract with the Ukraine. Sales in the service business increased by 4% to €56 million (Q1 2010: €54 million).

Fresenius Vamed achieved an EBIT of €5 million (Q1 2010: €7 million). The EBIT margin was 3.6%. Net income* was €4 million (Q1 2010: €6 million).

As of March 31, 2011, order backlog increased by 5% to a new all-time high of €842 million (Dec. 31, 2010: €801 million), driven by strong order intake of €127 million (Q1 2010: €260 million). Order intake includes a €67 million project to build a private health care facility in the Ukraine and a €29 million medical equipment contract for the National Cancer Institute in Malaysia.

Fresenius Vamed fully confirms its 2011 outlook and expects to achieve both sales and EBIT growth between 5% and 10%.

*Net income attributable to VAMED AG

Conference Call and Audio Webcast
As part of the publication of the results for the first quarter of 2011, a conference call will be held on May 4, 2011 at 2.00 p.m. CET (8.00 a.m. EST). 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.