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  • Fresenius Helios reiterates sales target of € 2.3 billion for 2010
  • Fresenius Vamed sees mid-term annual organic sales growth of 5 – 10 %

Bad Homburg. Fresenius Helios and Fresenius Vamed are in an excellent position for further sales and earnings growth despite an ongoing global economic downturn. Fresenius Helios and Fresenius Vamed, business segments of Fresenius SE, are hosting their first Capital Market Day in Berlin today to inform investors and analysts about strategies, growth opportunities and business activities. Fresenius Helios and Fresenius Vamed were created as new business segments in early 2008 from previous business segment Fresenius ProServe. The new organizational structure set the stage for the focused expansion of the two business segments and underlines the growing importance of the hospital market for the Fresenius Group. Fresenius Helios is one of Germany's three biggest hospital operators. Fresenius Vamed is a global leader in engineering and services for hospitals and other health care facilities.

Fresenius Helios and Fresenius Vamed expect further profitable growth despite the current global economic decline. The business segments operate in a mostly non-cyclical sector, where demand for high-quality and efficient medical care is growing, driven by demographic changes in developing and emerging countries. Fresenius Helios sees very good growth opportunities in the German hospital market and reiterates its sales target of € 2.3 billion in 2010. Fresenius Vamed expects to achieve organic sales growth of 5 – 10 % p.a. in the mid-term. In the first nine months of 2008, sales increased by 24 % to € 290 million mainly driven by the project business.

"We are very satisfied with the financial results and the growth perspectives of Fresenius Helios and Fresenius Vamed," says Ulf Mark Schneider, Chairman of the Management Board of Fresenius SE. "Both companies raised their 2008 financial targets. This confirms that their proven business models are prevailing during this difficult economic climate. Both are quality leaders in the market and offer excellence in healthcare and medicine."

Fresenius Helios
HELIOS operates 57 clinics, including five maximum care hospitals. Fifty-six are in Germany and one is in Switzerland. HELIOS treats about 550,000 inpatients annually and operates about 17,300 beds. In the first nine months of 2008, sales increased by 16 % to € 1.568 billion and EBIT grew by 15 % to € 127 million.

"The hospital market offers good growth prospects for the future," says Dr. Francesco De Meo, CEO of business segment Fresenius Helios. "Presently we see several privatization projects, and we will participate where we see a good strategic fit. In our negotiations with previous hospital owners, we have learned that our commitment to the highest medical quality and transparency helps us win projects."

HELIOS remains on track for its five-year goal, announced in 2005, to acquire € 800 million of hospital revenues between 2006 and 2010. At about € 450 million currently, the company firmly expects to reach that goal and to meet its sales target of € 2.3 billion in 2010.

HELIOS' business model is primarily based on growth through acquisitions and restructuring of acquired hospitals. HELIOS improves the acquired hospitals' profitability by improving operations and medical performance along with cost savings and investment in infrastructure and provides medical care of the highest quality. According to HELIOS' restructuring plan, hospitals are expected to achieve an EBITDA margin of 15 % within five years following acquisition.


Fresenius Vamed
Founded in 1982, VAMED has completed about 450 projects in 47 countries and is a global leader in providing planning, construction and management of complex health care facilities.

VAMED generates around 60 percent of its sales from its project business, which includes consulting, project development, project management and construction. About 40 % of sales are generated from the service business, which includes maintenance, technical, commercial and infrastructure services for health care facilities as well as operating these facilities in certain markets. VAMED offers a complete value chain to support hospitals efficiently and successfully at each level of their life cycle.

"We are well positioned to meet our targets this year," says Dr. Ernst Wastler, CEO of business segment Fresenius Vamed. "Order intake developed strongly and we see good opportunities for continued growth, strengthened by our integrated approach as contracts in our project business lead to contracts in our service business and vice versa."

VAMED is active in Europe, Africa, Asia-Pacific and Latin America and is successful in established and emerging markets. In established markets, medical facilities face challenges to increase their efficiency. VAMED offers them competitive hospital management, new technologies, outsourcing of technical, commercial and infrastructural services and public-private-partnerships. The company helps hospitals in established markets to concentrate on their core competency, the care of patients. In emerging markets, VAMED offers comprehensive know-how for the development of healthcare infrastructure, planning and construction of hospitals and a complete range of services, including total management.

In the first nine months of 2008, Fresenius Helios and Fresenius Vamed contributed 21 % to sales and 22 % to earnings after tax of Fresenius Group.

Fresenius will hold a live webcast of its Capital Market Day starting 8.30 a.m. today. The webcast is available at www.fresenius.com / investor relations / presentations. A replay will be available shortly after the event finishes.

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.

HELIOS Kliniken Group, a business segment of Fresenius SE, has strengthened its presence in the German hospital market. The company has agreed to acquire three hospitals in the Mansfeld-Südharz county of Saxony-Anhalt and two in the Northeim county of Lower Saxony. Combined sales of the five hospitals were approx. € 136 million in 2007.

The three acute care hospitals in Saxony-Anhalt are part of Krankenhaus-Holding GmbH Mansfeld-Südharz. They have a total capacity of 834 beds, of which 327 belong to Krankenhaus am Rosarium hospital in Sangerhausen and 507 to Klinikum Mansfelder Land & Pflege hospital, which has two locations in Lutherstadt Eisleben and Hettstedt. The three hospitals have about 1,600 employees and treated more than 30,000 patients in 2007. Sales were approx. € 86 million in the same period. HELIOS will own a 94.9 % stake in the hospitals, and the county will hold a 5.1 % share. With this acquisition HELIOS is now present in the German state of Saxony-Anhalt. In the neighboring state of Thuringia, HELIOS already owns four clinics - a maximum care hospital in Erfurt and clinics in Bleicherode, Gotha and Blankenhain.

The two hospitals in Lower Saxony were previously owned by Rhume-Leine-Gande-Klinikum GmbH. They have a total capacity of 371 beds, of which 273 belong to Albert-Schweitzer-Krankenhaus in Northeim and 98 to the Evangelische Krankenhaus in Bad Gandersheim. The two hospitals employ about 1,000 people and treated more than 16,300 patients in 2007. Sales were approx. € 50 million in the same period. HELIOS will own a 94.9 % stake in Albert-Schweitzer-Krankenhaus and a 94.8 % stake in Evangelische Krankenhaus. The Northeim county and the Evangelisches Krankenhaus Foundation will own 5.1 % and 5.2 % respectively. At the location in Northeim, HELIOS plans to build a new clinic to expand and improve medical services. HELIOS currently owns six clinics in the north of Germany - a maximum care hospital in Schwerin and clinics in Bad Schwartau, Cuxhaven, Geesthacht, Leezen and Hamburg.

"We are pleased with the decision of these two counties to award their privatization projects to HELIOS. Our concept focuses on medical quality and transparency," said Ulf Mark Schneider, Chairman of the Management Board of Fresenius SE. "With this acquisition, we continue our successful expansion in the German hospital market. The five clinics are well-positioned in their regions and offer considerable potential for enhanced medical care."

The parties agreed not to disclose the purchase prices. The acquisitions are still subject to the approval of county and anti-trust authorities. Additionally, the acquisition in Mansfeld-Südharz is subject to the approval of the Fresenius SE Supervisory Board. HELIOS expects to close these transactions in the first half of 2009.

HELIOS Kliniken Group has 57 clinics, of which 38 are acute hospitals and 19 are postacute care clinics. With five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal, HELIOS maintains a leading market position in the privatization of hospitals of this size in Germany. HELIOS is one of the biggest providers of in-patient and out-patient care in Germany and treats about 1.5 million patients annually, of whom about 550,000 are in-patients. HELIOS has more than 17,300 beds and 30,000 employees. Sales in 2007 were more than € 1.8 billion.

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.

A Phase II study with the trifunctional antibody catumaxomab in the treatment of patients with gastric cancer showed the antibody was well tolerated. The primary endpoint of the study – safety and tolerability of catumaxomab administration after tumor resection – was achieved. With this study, controlled results for perioperative administration of catumaxomab are presented for the first time.

The randomized, open-label study included 55 patients with resectable gastric cancer. Tumors of all patients were removed by surgery. 28 patients were included in the catumaxomab arm and treated intraoperatively with 10µg of catumaxomab. Seven days after surgery, these patients were given 10, 20, 50 and 150µg doses of catumaxomab by intraperitoneal administration in intervals of three days. The 27 patients in the control group received no anti-tumor therapy except tumor resection within the study period.

The pattern of complications from surgery was comparable in both groups, with catumaxomab having no impact. Most of the side effects in the catumaxomab group were mild to moderate and based on the mode of action of the antibody. Side effects were mostly limited to the treatment period and were, if needed, treated symptomatically.

Secondary study endpoints were efficacy parameters, e.g. overall survival. As expected, the study showed no statistically or clinically relevant differences between the catumaxomab arm and the control group 12 months after treatment. Due to this short follow-up period and the low number of patients it was not possible to reach specific conclusions regarding the efficacy of the therapy. Other studies with similar patient populations showed a difference in overall survival just after about two years.

After finalization of the ongoing second study in patients with gastric cancer, including neoadjuvant chemotherapy prior to surgery, the safety and tolerability data of catumaxomab administration during surgery will be evaluated. Additional analyses on efficacy of the therapy are also planned.

Background information:

Gastric Cancer

Gastric cancer is the fifth most common type of cancer in men and the seventh most common type of cancer in women. In 2004, about 11,000 men and about 7,800 women had gastric cancer in Germany. In men the incidence peak is at the age of approx. 70, in women it is above 75. (Source: Robert Koch Institute)
The prognosis of patients depends heavily on the stage of the tumor. While five-year survival rates for patients in stage I are up to 80 %, they decline in advanced stages, with a survival rate of about 20 % for patients in stage IIIb and below 5 % for stage IV.
The only curative treatment option is the partial or complete resection of the stomach (gastrectomy) and the regional lymph nodes. If the general condition of the patient is good, the surgery can be preceded by a neoadjuvant chemotherapy to reduce the size of the tumor, which led to a significant improvement of five-year survival to 36 % in a first Phase III study (MAGIC). If tumor tissue remains after the surgery, an additive chemotherapy is administered which might enable a second successful resection. In case of inoperable tumors or distant metastases, a palliative chemotherapy can be administered to alleviate the symptoms and prolong life.

Second Phase II Gastric Cancer Study GC03
In the second study IP-CAT-GC-03, a single-arm trial, gastrectomy follows chemotherapy (neoadjuvant). The primary endpoint of the study is safety and tolerability of the trifunctional antibody catumaxomab. The secondary endpoints are efficacy parameters such as overall survival and disease-free survival.

Trifunctional Antibodies
Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and target tumor cells specifically. 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 catumaxomab
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. Catumaxomab 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.

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 AG today announced that the share split with capital increase from the Company's funds approved by the Extraordinary General Meeting on December 4, 2006, will become effective on February 2, 2007. On the same day, the shares will be traded "ex split" and the shareholders' deposits will be adapted to the new number of shares. Every holder of an ordinary share now holds three ordinary shares and every holder of a preference share holds three preference shares.

The Fresenius shares will continue to trade under ISIN DE0005785604 (ordinary share) and ISIN DE0005785638 (preference share).

The subscribed capital of Fresenius AG now amounts to € 154.4 million, divided into 77,176,938 ordinary shares and 77,176,938 preference shares.

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.

  • Sales € 10.8 billion, + 37 % at actual rates, + 37 % in constant currency
  • EBIT € 1,444 million, + 49 % at actual rates, + 50 % in constant currency
  • Net income € 330 million, + 49 % at actual rates, + 49 % in constant currency
  • Sales exceeding the € 10 billion mark and EBIT exceeding the € 1 billion mark for the first time
  • Excellent sales and earnings growth in all business segments
  • Further margin improvements in all business segments achieved
  • 15 % increase in dividend per share proposed
  • Strong cash flow supports rapid de-levering

 

14th consecutive dividend increase proposed
2006 was the most successful year in the Company's history. Based on the Group's excellent financial results, the Management Board will propose to the Supervisory Board a dividend increase of 15 % to € 0.57 per ordinary share (2005, adjusted for the share split: € 0.49) and to € 0.58 per preference share (2005, adjusted for the share split: € 0.50). The total dividend distribution is expected to be € 88.8 million (2005: € 75.8 million).

  

Positive outlook for 2007
For 2007, Fresenius Group projects further improvements in sales and earnings. Group sales are expected to grow by 8 to 10 % in constant currency. Net income is expected to increase by 20 to 25 % in constant currency. We anticipate further margin improvements of all business segments to contribute to this growth.

Investments in property, plant and equipment and in intangible assets are planned to increase from € 600 million in 2006 to € 600 to 700 million.


Strong sales growth across all business segments and regions
Group sales increased by 37 % to € 10,777 million in 2006 (2005: € 7,889 million). Organic growth was 9 %. Acquisitions, in particular Renal Care Group and HELIOS Kliniken, contributed 29 %. Divestitures had a -1 % effect on sales. Currency translation effects had no impact.

Strong sales growth was achieved in the core markets of North America and Europe. In North America, sales grew significantly due to the Renal Care Group consolidation and an excellent organic growth rate of 9 %. In Europe, the substantial sales increase was mainly driven by the consolidation of HELIOS Kliniken. Organic growth in Europe was 5 %. Excellent growth rates were achieved in the emerging markets with organic growth of 19 % in Asia-Pacific, 22 % in Latin America and 18 % in Africa.

Sales contribution of the three business segments:

Fresenius ProServe's increased sales contribution is the result of the consolidation of HELIOS Kliniken.

 

Excellent earnings growth
Group operating income (EBIT) increased by 49 % at actual rates and by 50 % in constant currency to € 1,444 million (2005: € 969 million). The Group EBIT margin improved to 13.4 % (2005: 12.3 %). Operating income for the full year 2006 includes a gain of € 32 million from the divestitures of dialysis clinics in the USA. The sale was a condition of the US Federal Trade Commission for the approval of the Renal Care Group acquisition. Operating income for the full year 2006 also includes a total of € 44 million for one-time expenses, e.g. for the integration of Renal Care Group, as well as for expenses related to the stock option accounting change.

Group net interest was € -395 million (2005: € -203 million). The increase was primarily driven by the debt financing of the Renal Care Group acquisition. Net interest also includes one-time expenses of € 30 million associated with the early refinancing of Group debt.

The tax rate was 39.5 % (2005: 38.9 %). It was substantially influenced by the tax expense associated with the divestiture of the dialysis clinics in the USA as the goodwill attributable to the divested clinics is not considered for tax purposes. Excluding this effect the tax rate was 37.2 %, well within our guidance of 36 to 38 %.

Minority interest was € 305 million (2005: € 246 million), of which 93 % was attributable to the minority interest in Fresenius Medical Care.

Group net income grew strongly by 49 % at actual rates as well as in constant currency to € 330 million (2005: € 222 million). Net income includes a total of € 29 million for one-time expenses, primarily for the early refinancing of debt, for the integration of Renal Care Group, and for expenses related to the stock option accounting change.

Earnings per ordinary share were € 2.15 (2005, adjusted for the share split: € 1.76) and earnings per preference share* were € 2.16 (2005, adjusted for the share split: € 1.77). This is an increase of 22 % for both share classes. The average number of shares grew to 153,006,012 in 2006.

* In accordance with SFAS 128 („Earnings per Share") the calculation of basic and diluted earnings per share for the fiscal years 2006 and 2005 have been adjusted retrospectively by the increased weighted average number of shares outstanding.

Capital expenditure at high level
Fresenius Group spent € 600 million for property, plant and equipment and intangible assets (2005: € 353 million). Acquisition spending increased to € 3,714 million mainly due to the Renal Care Group acquisition (2005: € 1,894 million).


Strong cash flow
Operating cash flow increased by 35 % to € 1,052 million (2005: € 780 million). Key drivers were the strong increase in earnings and further improvements in working capital management. Cash flow before acquisitions and dividends was € 481 million (2005: € 449 million). The acquisition of Renal Care Group was entirely debt-financed.


Solid balance sheet structure
Total assets increased by 30 % to € 15,024 million (December 31, 2005: € 11,594 million). In constant currency, total assets grew by 38 %. The substantial increase is mainly related to the consolidation of the Renal Care Group. Current assets increased by 16 % to € 4,106 million (December 31, 2005: € 3,531 million). Non-current assets were € 10,918 million (December 31, 2005: € 8,063 million), an increase of 35 %.

Shareholders' equity including minority interest grew by 12 % to € 5,728 million (December 31, 2005: € 5,130 million), driven by the very good earnings development. Given the debt financing of the Renal Care Group acquisition, the equity ratio (including minority interest) decreased to 38.1 % (December 31, 2005: 44.2 %).

Group debt increased to € 5,872 million (December 31, 2005: € 3,502 million) due to the financing of the Renal Care Group acquisition.

As of March 31, 2006, following the closing of the Renal Care Group acquisition, the net debt/EBITDA ratio was at 3.5. Given the excellent earnings growth and a strong cash flow the net debt/EBITDA ratio improved significantly to 3.0 as of December 31, 2006 (December 31, 2005: 2.3).


Employees
As of December 31, 2006, the Group had 104,872 employees (December 31, 2005: 91,971). The increase of 12,901 employees is primarily due to the acquisitions of Renal Care Group and HUMAINE Kliniken.


Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer as well as cell therapies for the treatment of the immune system. 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.

In December 2006, first results of a phase II/III pivotal study on malignant ascites in patients with ovarian cancer were published, including treatment data of 129 patients. The results showed a clear advantage of the therapy with the trifunctional antibody removab® over a therapy with puncture alone. The results of 128 patients with tumor diseases other than ovarian cancer (e.g. gastric cancer) are expected for the first quarter of 2007. Data on overall survival of all patients of the study are expected in the second quarter of 2007. The application dossier for marketing authorization for removab® in malignant ascites is planned to be submitted to the European Medicines Agency (EMEA) in the second half of 2007.

In June 2006, Fresenius Biotech published the results of a phase Ila study in the treatment of ovarian cancer patients assessing tolerability, dose regimen and efficacy. Based on the encouraging results, the company plans to start a phase II study in this indication in Europe in the first half of 2007.

The phase II study with the antibody rexomun® to treat breast cancer, which started in March 2006, and the phase II study with the antibody removab® to treat gastric cancer, which started in June 2006, are ongoing.

Fresenius Biotech's operating income (EBIT) was € -45 million in 2006 (2005: € -41 million). For 2007, Fresenius Biotech expects an EBIT of approximately € -50 million.


The Business Segments

Fresenius Medical Care


Fresenius Medical Care is the world's leading provider of products and services for patients with chronic kidney failure. As of December 31, 2006, Fresenius Medical Care was serving 163,517 patients in 2,108 dialysis clinics.

* before one-time expenses, expenses related to the stock option accounting change and the effect of the FTC-related clinic divestitures in the USA; excluding 2005 one-time expenses.

  • Excellent sales and earnings growth in all regions
  • Integration of Renal Care Group successfully completed
  • Outlook 2007: double-digit sales and earnings growth expected

Fresenius Medical Care achieved strong sales growth of 26 % to US$ 8,499 million (2005: US$ 6,772 million). This was mainly driven by the excellent organic growth of 10 % and the consolidation of the Renal Care Group. Sales in dialysis care increased by 31 % to US$ 6,377 million (2005: US$ 4,867 million). In dialysis products Fresenius Medical Care achieved sales of US$ 2,122 million (2005: US$ 1,905 million), an increase of 11 %.

In North America Fresenius Medical Care's sales increased by 32 % to US$ 6,025 million (2005: US$ 4,577 million). Organic growth of 9 % in this region was excellent. Sales outside North America ("International") grew by 13 % (12 % in constant currency) to US$ 2,474 million (2005: US$ 2,195 million).

Net income increased by 18 % to US$ 537 million (2005: US$ 455 million). This result includes one-time expenses of US$ 47 million primarily for the early refinancing of debt, for the integration of Renal Care Group, and expenses related to the stock option accounting change as well as for the after-tax loss on the divestiture of dialysis clinics in the USA. Excluding the above effects and adjusted by one-time expenses in the previous year, net income increased by 24 % to US$ 584 million.

For the full year 2007, Fresenius Medical Care expects revenue to be about US$ 9.4 billion. The net income is expected to be between US$ 675 million and US$ 695 million in 2007.

For further information, please see Fresenius Medical Care's Investor News at www.fmc-ag.com


 

Fresenius Kabi

Fresenius Kabi offers infusion therapies and clinical nutrition for seriously and chronically ill patients in the hospital and out-patient environments. The company is also a leading provider of transfusion technology products.

  • Strong organic sales growth of 8 %
  • EBIT margin at new record levels in the fourth quarter and for the full year 2006
  • Outlook 2007: strong margin growth and increase in earnings expected

In 2006, Fresenius Kabi's sales increased by 13 % to € 1,893 million (2005: € 1,681 million). The company achieved strong organic growth of 8 %. Acquisitions, primarily Clinico and Australian Pharmatel, contributed 4 % to sales. Currency translation effects contributed 1 % to growth.

Sales in Europe (excluding Germany) increased by 7 %, in Germany by 5 %.
Fresenius Kabi continued its exceptional growth outside Europe and achieved sales growth of 41 % in Asia-Pacific, 27 % in Latin America and 17 % in the other regions. Organic growth in the regions outside Europe was again well into the double digits.

Earnings at Fresenius Kabi reached new record levels: EBIT increased by 24 % to € 291 million (2005: € 234 million). The EBIT margin improved to 15.4 % in the full year 2006 (2005: 13.9 %). The original mid-term EBIT margin target of about 15.5 % by 2007 was therefore reached ahead of time. In the fourth quarter, the EBIT margin reached a new record level of 16.0 %. Net profit rose by 29 % to € 143 million (2005: € 111 million). This already includes one-time expenses of € 11 million for the early refinancing of the 2003 Euro Bond.

In 2007, Fresenius Kabi expects a positive sales and earnings performance. Organic sales growth is projected to be 6 to 8 %. Strong sales growth is anticipated again from the regions outside Europe. Based on the positive sales projection and further manufacturing and logistics improvements Fresenius Kabi expects an EBIT margin of 16.0 to 16.5 % in 2007.

Also for the mid-term, Fresenius Kabi expects to continue its positive financial performance: The company targets organic sales growth of 6 to 8 %. Further, Fresenius Kabi foresees its EBIT margin in the 16 to 18 % range.


 

Fresenius ProServe

Fresenius ProServe is a leading German hospital operator with 55 facilities. Moreover, the company offers engineering and services for hospitals and other health care facilities.
 

  • Very good revenue and earnings development in the hospital operations business
  • Strong order intake in engineering and services business
  • Outlook 2007: Continued sales and earnings improvements expected

Fresenius ProServe's sales grew by 7 % to € 2,155 million in 2006 (2005 including HELIOS Kliniken: € 2,009 million). Organic growth was 3 %. EBIT increased by 23 % to € 154 million (2005 including HELIOS Kliniken: € 125 million).

Sales in hospital operations (HELIOS Kliniken Group) increased by 8 % to € 1,673 million (2005 including HELIOS Kliniken : € 1,550 million). The sales growth is mainly attributable to the acquisition of HUMAINE Kliniken, which was consolidated as of July 1, 2006. However, HELIOS also achieved strong organic growth of 3 %. EBIT increased to € 133 million, the EBIT margin improved to 7.9 % (2005 including HELIOS Kliniken: € 107 million and 6.9 %).

HELIOS continued its growth strategy in the German hospital market. In January 2007, the company has agreed to acquire two hospitals in North-Rhine Westphalia with a total of 333 beds and sales of about € 32 million in 2006. The acquisition still requires approval by the antitrust authorities.

Sales in the engineering and services business (VAMED, Pharmaplan) increased by 5 % to € 482 million (2005: € 459 million). EBIT rose by 14 % to € 25 million (2005: € 22 million). Order intake and order backlog continued to develop very positively: Order intake increased by 19 % to € 407 million (2005: € 341 million). Order backlog also grew by 19 % to € 428 million as of December 31, 2006 (December 31, 2005: € 360 million).

In December 2006, Fresenius ProServe has signed a definitive agreement to sell its subsidiary Pharmaplan GmbH to NNE A/S (NNE). NNE is a wholly-owned subsidiary of Novo Nordisk A/S, Copenhagen. The approval by the antitrust authorities is expected in the first quarter of 2007. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its business with hospitals and other healthcare facilities.

Fresenius ProServe projects further improvements in sales and earnings. Future growth potential is mainly expected from hospital privatizations in Germany. For 2007, Fresenius ProServe forecasts organic sales growth of 2 to 3 %. EBIT is expected to increase to € 160 to 170 million.


 

Video Webcast
As part of the publication of our results for the fiscal year 2006, an analyst conference will be held at the Fresenius headquarters in Bad Homburg on February 22, 2007 at 1:30 p.m. CET (7.30 a.m. EST). All investors are cordially invited to follow the conference in a live broadcast over the Internet at www.fresenius-ag.com / Investor Relations / Presentations. Following the meeting, a recording of the conference will be available as video-on-demand.

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 today announced encouraging results in the non-ovarian cancer patient stratum of a phase II/III pivotal study on malignant ascites using the trifunctional antibody removab® (catumaxomab). After positive results in the treatment of patients with ascites from ovarian cancer (see Investor News December 18, 2006 for ovarian stratum), the antibody again showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (primary endpoint) in the patient group treated with removab® was significantly longer compared to the control group and clinically relevant. The median puncture-free survival was 37 days in the removab® group versus 14 days in the control group (p< 0.0001).

In the subgroup of patients with ascites from gastric cancer (51 % of all non-ovarian cancer patients) the difference was even more marked with a median puncture-free survival of 44 days in the removab® group versus 15 days in the control group (p<0.0001). All other patients (10 % breast, 7 % pancreatic, 6 % colorectal cancer, 26 % others) had a median puncture-free survival of 30 days (removab®) versus 9 days in the control group (p<0.0003). On a pooled basis for both strata (ovarian and non-ovarian cancers) the median puncture-free survival was 46 days in the removab® group versus 11 days in the control group (p<0001).

Positive results were also achieved in key secondary endpoints. Of special importance was the length of time between treatment and first therapeutic puncture (median time to the first therapeutic puncture). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric. As a result, this secondary endpoint is not affected by the prognosis of these patients at the onset of ascites. The median time to the first therapeutic puncture for all non-ovarian cancers was 80 days (control group: 15 days; p< 0.0001). Patients with gastric cancer benefited especially from the treatment. Median time to the first therapeutic puncture was 118 days in the removab® group versus 15 days in the control group (p< 0.0001). For all other patients the median time to the first therapeutic puncture in the removab® group was 69 versus 15 days in the control group (p< 0.0001). On a pooled basis for both strata (ovarian and non-ovarian cancers) the median time to the first therapeutic puncture was 77 days in the treatment group versus 13 days in the control group (p< 0.0001). In addition, the EpCAM-positive tumor cell concentration in the ascites fluid decreased in patients treated with removab®. At the same time, an increase in CD45-positive leukocytes was seen. Both results indicate a direct anti-tumor effect of the trifunctional antibody.

Removab® showed a very good safety profile in this stratum. This is particularly important as malignant ascites occurs at a very late stage in patients with non-ovarian cancers. Drug-related adverse events due to cytokine release were mild to moderate and mostly fully reversible, with fever, nausea and vomiting being the most common. Pathologic increases of liver parameters and undesirable changes in white blood cell counts were also mild to moderate, transient and mostly without clinical relevance.

"These results continue to support the potential of removab. They demonstrate the significant benefit for ascites patients due to non-ovarian cancers even though they have a worse prognosis compared to ovarian cancer. This indicates that removab® could also play an important role in the treatment of ascites for all underlying non-ovarian cancers," said Dr. Thomas Gottwald, President Fresenius Biotech.

The phase II/III pivotal trial with the trifunctional antibody removab® included a total of 258 patients divided in two strata: ovarian cancer (129 patients) and non-ovarian cancers (129 patients). Based on a 2:1 randomization ratio, the removab® arm in the non-ovarian stratum included 85 patients, of which 62 received all four doses of 10, 20, 50 und 150 µg each. The intraperitoneal infusions were administered over a six-hour period in intervals of three to four days.

Non-ovarian cancer patients account for about 80 % of all malignant ascites cases. The encouraging results of this study signifcantly increase the number of patients that is potentially eligible for the removab® treatment.

Data on overall survival in connection with the study are expected in the second quarter of 2007 due to the longer follow-up period associated with this secondary endpoint. Market launch of removab® is expected in 2008.

 

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Puncture-free survival period
Period between the last infusion (control group: day of the puncture) and the first subsequent necessary puncture or death, which ever occurs first.

Trifunctional Antibodies
Trifunctional antibodies are developed by Fresenius Biotech in cooperation with TRION Pharma. Trifunctional antibodies are proteins that bring together cancer cells with two different cell types of the immune system: T-cells and accessory cells (e.g., natural killer cells, macrophages). This mode of action of the trifunctional antibody is the basis for an immune response against the tumor.

 

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Fresenius Biotech 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.

Additional information is available on the Internet at www.fresenius-biotech.de.

This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

Fresenius ProServe closed the announced divestiture of its subsidiary Pharmaplan GmbH to NNE A/S on March 31, 2007. All necessary antitrust approvals were received by NNE prior to the completion of the acquisition.

NNE is a wholly-owned subsidiary of Novo Nordisk A/S, Copenhagen, a pharmaceutical company with approximately 23,200 employees worldwide and annual sales of € 5,194 million in 2006.

Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical industry worldwide. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its two core areas hospital operations (HELIOS Kliniken) and hospital engineering and services (VAMED).

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.

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