Fresenius Biotech today announced encouraging results from a Phase IIa study with the trifunctional antibody removab^® (INN: catumaxomab) in the treatment of ovarian cancer patients. This European multi-center study was designed to assess the relative safety and efficacy of two different dose regimens, and included 44 patients with advanced ovarian cancer that were resistant to platinum and paclitaxel standard chemotherapy following surgery or had relapsed within six months of treatment. Both dose regimens were associated with the same mild to moderate toxicity profile, and the high dose treatment group showed a better tumor response. Currently, there are no other generally accepted treatment options for this patient population.

Patients were given four doses of removab^® via intraperitoneal administration over a period of ten days. The primary objective of the study was to determine whether application of a constant low dose (10-10-10-10 µg) or an escalated dose (10-20-50-100 µg) yielded a difference in either tolerability or response rate.

The study yielded two key findings:

• The antibody was well tolerated even at higher doses. Only moderate and temporary side effects were observed at both dose regimens, including fever, nausea and vomiting, and local skin reaction.
• The higher dose regimen yielded a clearly better anti-tumor efficacy, with one complete response (out of 22 patients) in this group. Four instances of stable disease were observed in the higher dose regimen. Two instances of stable disease were observed with the constant low dose regimen.

Based on the encouraging results of this Phase Ila study, Fresenius Biotech is planning to start a European Phase II study in the second half of 2006 to investigate the efficacy of removab^® in the treatment of ovarian cancer. In this study the additional benefit of removab^® in conjunction with surgery and standard chemotherapy will be investigated. As of today, the study will be designed to treat about 40 patients in earlier stages of the disease. These patients will receive four postoperative doses, as in the Phase IIa study, and an additional dose immediately after the tumor mass has been resected (R0 and RI resection).

Background information

Trifunctional antibodies: The trifunctional antibodies developed by Fresenius Biotech's partner TRION Pharma are proteins that join cancer cells with two different defensive cells from the body's own immune system: T-Cells and accessory cells. This initiates an especially efficient destruction of tumor cells.

Study phases: The goal of a Phase I study is to determine potential dosages and side effects while a Phase II investigates the effectiveness and safety of a medication using a low number of patients. A Phase IIa study is used to compare the safety and efficacy of various dosages. A Phase III study evaluates the effectiveness of a drug using a larger number of patients. The drug is also compared with standard treatments and a risk analysis is performed.

Ovarian cancer affects an average of 12.8 of 100,000 women and is the sixth most common cancer among women. In 2002, the World Health Organization registered more than 200,000 new cases worldwide and more than 120,000 patients died of the disease that year. Because there are no early warning signs for ovarian cancer, three-fourths of all cases are first diagnosed at an advanced stage. Despite improvements in chemotherapy with platinum, two-thirds of all patients fail to react to this treatment or relapse. This results in a relatively low survival rate with just 30 to 40 percent of ovarian cancer patients surviving the first five years.

• Sales € 5.1 billion, + 37 % at actual rates, + 34 % in constant currency
• EBIT € 681 million, + 50 % at actual rates, + 46 % in constant currency
• Net income € 140 million, + 39 % at actual rates, + 36 % in constant currency

• Fresenius Medical Care with strong sales and earnings growth
• Fresenius Kabi in the second quarter with EBIT margin record of more than 15 %
• Fresenius ProServe fully on track
• Integration of Renal Care Group progressing well; integration of HELIOS/WKA completed

 
Group outlook 2006: Sales and earnings forecast raised
Given the Company's strong performance in the first half, Fresenius raises its full-year 2006 sales and earnings outlook. Group sales are now expected to increase by approximately 35 % in constant currency to about € 10.7 billion. Net income is projected to grow by about 40 % in constant currency. The net income guidance already includes an amount of approximately € 27 million (after tax) associated with expected one-time expenses as well as expenses related to the stock option accounting change. Previously, the Company had expected net income growth to exceed 30 %. Earnings per share are now projected to increase by approximately 15 % in constant currency. Previously, earnings per share growth of around 10 % had been projected.

Sales – Strong growth continues
Group sales increased by 37 % to € 5,078 million (H1 2005: € 3,702 million). Excellent organic growth contributed 9 % to revenue growth. Acquisitions, in particular the first-time consolidation of Renal Care Group and HELIOS Kliniken in the income statement, contributed 25 %. Currency translation effects added 3 % to sales growth.

In North America, sales grew significantly due to the first-time consolidation of Renal Care Group. In addition, organic growth was excellent with 8 %. In Europe, the substantial sales increase was driven by the first-time consolidation of HELIOS Kliniken. However, underlying organic growth came in at a very good rate of 7 %. Excellent growth rates were achieved in the emerging markets, with organic growth of 24 % in Asia-Pacific and 19 % each in Latin America and Africa.

 

Sales contribution of the three business segments:

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


Strong earnings growth
Group EBIT increased by 50 % at actual rates and by 46 % in constant currency to € 681 million (H1 2005: € 453 million). The growth was driven by the successful operating performance of all business segments as well as the first-time consolidation of Renal Care Group and HELIOS Kliniken. EBIT 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. EBIT also includes a total of € 11 million one-time expenses and expenses related to the stock option accounting change.

Primarily, given the debt financing of the Renal Care Group acquisition, Group net interest increased to € -194 million (H1 2005: -97 million). This number however also includes one-time expenses of € 30 million associated with the refinancing of Group debt.

The tax rate was 41.9 % (H1 2005: 39.3 %). It was substantially influenced by the tax expense associated with the divestitures of the dialysis clinics in the USA. As the goodwill attributable to the divested clinics is not considered for tax purposes, the sale resulted in a loss of € 2 million after tax. Excluding this effect the tax rate was 36.9 %.

Minority interest was € 143 million (H1 2005: € 115 million). 94 % was attributable to the minority interest of Fresenius Medical Care.

Group net income grew by 39 % at actual rates and by 36 % in constant currency to € 140 million (H1 2005: € 101 million). This result includes one-time expenses of € 19 million, primarily for the refinancing of debt as well as for expenses related to the stock option accounting change. Thus, approximately 70 % of the expected one-time expenses for the full-year 2006 are already included in the Group net income.

Earnings per ordinary share rose to € 2.75 (H1 2005: € 2.46) while earnings per preference share rose to € 2.77 (H1 2005: € 2.48). This is an increase of 12 % for both share classes (9 % in constant currency). The average number of shares grew to 50,852,320 mainly due to the share issue in December 2005.

Investments
Fresenius Group spent € 225 million for property, plant and equipment and intangible assets (H1 2005: € 115 million). Acquisition spending increased to € 3,408 million due to the acquisition of Renal Care Group (H1 2005: € 227 million).

Cash flow
Operating cash flow increased by 17 % to € 385 million (H1 2005: € 329 million). The key driver was the significant improvement in earnings whereas the tax expense associated with the divestitures of the dialysis clinics had a negative effect. Cash flow before acquisitions and dividends was € 172 million (H1 2005: € 224 million). The acquisition of Renal Care Group was financed through bank debt.

Solid balance sheet structure
Total assets increased by 28 % to € 14,831 million (December 31, 2005: € 11,594 million). In constant currency, total assets grew 34 %. The substantial increase is mainly related to the Renal Care Group acquisition which was consolidated in the balance sheet for the first time as of March 31, 2006. Current assets increased by 10 % to € 3,871 million (December 31, 2005: € 3,531 million). Non-current assets were € 10,960 million (H1 2005: € 8,063 million), an increase of 36 %. This was primarily due to the goodwill resulting from the Renal Care Group acquisition.

Group debt increased to € 6,154 million (December 31, 2005: € 3,502 million) due to financing of the Renal Care Group acquisition.

As of June 30, 2006, the net debt/EBITDA ratio was 3.3 (December 31, 2005: 2.3).

Shareholders' equity including minority interest grew 5 % to € 5,380 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 interests) decreased to 36.3 % (December 31, 2005: 44.2 %).

Employees
As of June 30, 2006, the Group had 100,196 employees worldwide (December 31, 2005: 91,971). The increase of 8,225 employees is primarily due to the acquisition of Renal Care Group.

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.

Fresenius Biotech has successfully continued its clinical study program. The company reported encouraging results of a phase IIa study with the trifunctional antibody removab^® in the treatment of ovarian cancer patients. Based on these results, Fresenius Biotech is planning to start a European phase II study for this indication in the second half of 2006.

A phase II study on breast cancer started in March 2006. About 40 patients will be included in the trial. A phase II study for the treatment of gastric cancer with approximately 50 patients started in June 2006. The results from the malignant ascites phase II/III study are expected at the end of this year.

For the full year 2006, Fresenius Biotech continues to expect an EBIT in the range of € -45 to -50 million, largely due to the higher expenses for expanded clinical study program.


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 June 30, 2006, Fresenius Medical Care (incl. Renal Care Group and after divestitures) was serving 161,675 patients in 2,078 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

 

• Strong sales and earnings growth in all regions
• Renal Care Group integration well under way and on track
• Outlook for 2006 upgraded

Fresenius Medical Care achieved strong sales growth of 19 % to US$ 3,912 million (H1 2005: US$ 3,283 million). This was driven by both the excellent operating performance and the first-time consolidation of Renal Care Group in the income statement. Organic growth reached 9 %. Sales in dialysis care increased by 24 % to US$ 2,924 million (H1 2005: US$ 2,363 million). In dialysis products, Fresenius Medical Care achieved sales of 988 million US$ (H1 2005: US$ 920 million), an increase of 7 % (10 % in constant currency).

In North America, Fresenius Medical Care increased sales by 24 % to US$ 2,754 million (H1 2005: US$ 2,215 million). Organic growth reached 8 %. Sales outside North America ("International") grew by 8 % (12 % in constant currency) to US$ 1,158 million (H1 2005: US$ 1,068 million).

Net income increased by 10 % to US$ 246 million (H1 2005: US$ 223 million). This result includes one-time expenses of US$ 20 million primarily for the refinancing of Fresenius Medical Care debt, for expenses related to the stock option accounting change as well as for the after-tax loss on the divestitures of dialysis clinics in the USA. Excluding the above effects net income was up 19 % to US$ 266 million.

Based on the strong performance in the first half of 2006, Fresenius Medical Care upgrades its guidance for the full year 2006. After expecting to report a revenue of about US$ 8.1 billion, the company now expects a revenue for 2006 of about US$ 8.3 billion.

Fresenius Medical Care also upgrades its outlook for reported net income for 2006. After expecting a net income between US$ 515 million and US$ 535 million, the company now expects to report a net income of at least US$ 542 million, which represents an increase of at least 15% over the 2005 level.

In order to show the underlying performance of Fresenius Medical Care, the guidance provided does not take into effect any expected one-time items and the stock option accounting change. After previously assuming the after-tax impact of one-time items and the stock option accounting change to be about US$ 60 million Fresenius Medical Care now expects this impact to be about US$ 40 million for the full year 2006.

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 %
• Record EBIT margin of more than 15 % in the second quarter
• Sales and earnings outlook for 2006 raised

Fresenius Kabi's sales increased by 15 % to € 937 million (H1 2005: € 818 million). The company achieved strong organic growth of 8 %. Acquisitions, primarily Clinico and the first-time consolidation of Pharmatel, contributed 4 % to sales. Currency translation added a further 3 %.

Sales in Europe (excluding Germany) increased by 9 %, in Germany by 5 %.
Fresenius Kabi did extremely well in the emerging markets outside Europe and achieved sales growth of 44 % in Asia-Pacific, 36 % in Latin America and 25 % in the other regions. Organic growth in the regions outside Europe was well into the double digits.

Fresenius Kabi showed an excellent performance at the EBIT level, with an increase of 26 % to € 139 million (H1 2005: € 110 million). The EBIT margin improved by 140 basis points to 14.8 % (H1 2005: 13.4 %). In the second quarter, the EBIT margin reached a new record level of 15.1 %. Net profit rose by 18 % to € 60 million (H1 2005: € 51 million). This already includes one-time expenses of € 11 million for the early redemption of the 2003 Eurobond.

Based on the excellent performance in the first half, Fresenius Kabi raises its EBIT margin outlook for the full year 2006 from previously 14.5-15.0 % to now >15 %. The company now expects sales growth of 11 to 12 % in constant currency. Previously, growth of around 10 % had been projected.

Fresenius ProServe
Fresenius ProServe is a leading German hospital operator with more than 50 facilities. Moreover, the company offers engineering and services for hospitals and other health care facilities as well as for the pharmaceutical industry.
 

• Very good performance in hospital operations
• Strong order intake in the engineering & services businesses
• Outlook for 2006 fully confirmed

Fresenius ProServe achieved excellent financial results. Sales grew by 3 % to € 974 million (H1 2005 incl. HELIOS Kliniken: € 942 million). Organic growth amounted to 4 %. On a comparable basis, EBIT increased by 15 % to € 62 million (H1 2005 incl. HELIOS Kliniken: € 54 million).

Sales in hospital operations (HELIOS Kliniken Group) amounted to € 767 million (H1 2005: € 765 million). Organic growth was 2 %. EBIT increased to € 56 million, the EBIT margin improved to 7.3 % (H1 2005 incl. HELIOS Kliniken: € 48 million and 6.3 %). The integration of WKA into HELIOS Kliniken Group was successfully completed. The focus is now on continued efficiency improvements at the WKA clinics and on further growth through privatization in the German hospital market.

Sales in the engineering and services business (VAMED, Pharmaplan) increased 17 % to € 207 million (H1 2005: € 177 million). EBIT rose 50 % to € 9 million (H1 2005: € 6 million). Order intake and order backlog continued to develop very positively. Order intake increased by 19 % to € 185 million (H1 2005: € 156 million). Order backlog rose 14 % to € 409 million as of June 30, 2006 (December 31, 2005: € 360 million).

In March 2006, HELIOS Kliniken agreed to acquire HUMAINE Kliniken GmbH. HUMAINE operates six acute and post-acute care hospitals with a total of 1,850 beds. The transaction is expected to be completed in the third quarter. The acquisition of HUMAINE will be accretive to Fresenius Group's earnings per share in the fiscal year 2006 already.

Fresenius ProServe confirms its 2006 full-year outlook and expects revenue growth of 1 to 3 % before acquisitions, based on 2005 revenues including HELIOS of € 2,009 million. EBIT is forecast to rise to € 140 to 150 million (2005 incl. HELIOS: € 125 million).

Video Webcast
As part of the publication of our results for the first half of 2006, an analyst conference will be held at the Fresenius headquarters in Bad Homburg on August 3, 2006 at 1:30 p.m. CEDT (7.30 a.m. EDT). 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.

Quarterly report
The report for the first half and the second quarter of 2006 will be available on August 14, 2006 on the Internet at www.fresenius-ag.com / Investor Relations / Financial Reports / Quarterly Reports.

The Management Board and Supervisory Board of Fresenius AG will propose to its shareholders in an extraordinary general meeting on December 4, 2006, to convert the Company's legal form from a German AG (Aktiengesellschaft) into a European Company (Societas Europaea – SE). This is a public limited-liability company under European law. At the same time, the shareholders will be asked to approve a share split that triples the number of shares issued.

After the successful expansion of the Group's international business and the strong growth in recent years, the proposed conversion into a European Company is a consistent step in the company's development. The SE is a modern legal form based on European law which will underline the Group's international focus and facilitate an open and international corporate culture at Fresenius.

As a European Company, Fresenius remains committed to high-quality and efficient corporate governance practices. The conversion does not have any effect on the Company's corporate structure and management organization. The two-tier system consisting of Management Board and Supervisory Board will remain unchanged. The Supervisory Board of Fresenius SE will continue to have twelve members. However, employee representatives from various European countries will be represented on the Supervisory Board. Currently, only German employee representatives serve on the Company's Supervisory Board. The same size of the Supervisory Board ensures that the efficiency of the Company's corporate governance will be preserved. Without the proposed conversion, Fresenius would have to increase the number of Supervisory Board members to twenty due to the increased number of German employees.

Fresenius will continue to have its registered office in Germany. The conversion into an SE does not lead to a liquidation of the company or to the formation of a new legal entity. The Company's legal and economic identity will be preserved. In addition, the conversion does not result in any tax consequences for Fresenius. All shareholder's stakes in Fresenius will remain unchanged.

"The European Company enables us to reflect the international focus of our business in the legal form while we continue our well-proven corporate governance. At the same time, the SE assures the representation of our European employees on the Supervisory Board", says Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG.

The proposed share split is intended to promote trading activity in Fresenius shares and to increase the shares' attractiveness for a broader group of investors. Fresenius share prices have increased significantly in recent years: Since the end of 2004, the share prices of the ordinary share and the preference share have almost doubled. The preference share price is currently one of the highest in Germany's HDAX index.

The subscribed capital of Fresenius AG currently amounts to € 131.5 million*. It is divided into 25,688,455 ordinary shares and 25,688,455 preference shares. Through a conversion of capital reserves, the subscribed capital is first increased to € 154.1 million. The subscribed capital is then divided into 77,065,365 ordinary shares and 77,065,365 preference shares. The new proportionate amount of the subscribed capital will be 1 € per share. After the share split, every holder of an ordinary share will hold three ordinary shares and every holder of a preference share will hold three preference shares. As a result of the share split, the price level will be reduced arithmetically without affecting the overall value for shareholders.

^* including the capital increase from authorised capital against contribution in kind in the amount of € 903,884.80 in the course of the acquisition of HUMAINE Kliniken GmbH, which yet has to be registered in the commercial register

• Sales € 7.8 billion, + 37 % at actual rates, + 36 % in constant currency
• EBIT € 1.1 billion, + 51 % at actual rates, + 49 % in constant currency
• Net income € 233 million, + 45 % at actual rates, + 43 % in constant currency

• Fresenius Medical Care with excellent performance
• Fresenius Kabi with new record EBIT margin in the third quarter
• Fresenius ProServe sales and earnings fully on track
• Group EBIT for the first time exceeds one billion Euro mark

 

 

Group outlook 2006: Earnings forecast raised
Based on the Company's strong financial results in the third quarter, Fresenius raises its full-year 2006 earnings outlook. Net income is now projected to grow by 40 to 45 % in constant currency. This guidance already includes an amount of approximately € 28 million (after tax) associated with expected one-time expenses as well as expenses related to the stock option accounting change. Previously, the Company had expected net income growth of approximately 40 %. Group sales are expected to increase to more than € 10.7 billion.

Sales growth across all business segments and regions
Group sales increased by 37 % to € 7,843 million (Q1-3 2005: € 5,712 million). Excellent organic growth contributed 9 %. Acquisitions, in particular Renal Care Group and HELIOS Kliniken, added 28 %. Divestitures had a -1 % effect on sales. Currency translation effects contributed 1 % to sales growth.

In North America, sales grew significantly due to the Renal Care Group consolidation and an excellent organic growth rate of 8 %. 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 25 % in Asia-Pacific, 20 % 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.

Strong earnings growth
Group EBIT increased by 51 % at actual rates and by 49 % in constant currency to € 1,060 million (Q1-3 2005: € 703 million) exceeding the one billion Euro mark for the first time. EBIT 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. EBIT also includes a total of € 20 million for one-time expenses, mainly for the integration of Renal Care Group as well as for expenses related to the stock option accounting change.

Group net interest was € -295 million, primarily as a result of the debt financing of the Renal Care Group acquisition (Q1-3 2005: € -146 million). Net interest however also includes one-time expenses of € 30 million associated with the early refinancing of Group debt.

The tax rate was 40.9 % (Q1-3 2005: 39.3 %). 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 37.8 %.

Minority interest was € 219 million (Q1-3 2005: € 177 million). Thereof, 93 % was attributable to the minority interest in Fresenius Medical Care.

Group net income grew strongly by 45 % at actual rates and by 43 % in constant currency to € 233 million (Q1-3 2005: € 161 million). This includes a total of € 22 million for one-time expenses, primarily for the early refinancing of debt, as well as for expenses related to the stock option accounting change.

Earnings per ordinary share were € 4.56 (Q1-3 2005: € 3.92) while earnings per preference share were € 4.58 (Q1-3 2005: € 3.94). This is an increase of 16 % for both share classes (15 % in constant currency). The average number of shares grew to 50.9 million, mainly due to the share issue in December 2005.

Investments
Fresenius Group spent € 374 million for property, plant and equipment and intangible assets (Q1-3 2005: € 196 million). Acquisition spending increased to € 3,537 million (Q1-3 2005: € 264 million) mainly due to the acquisition of Renal Care Group.

Cash flow
Operating cash flow was € 588 million (Q1-3 2005: € 592 million). The strong earnings improvement was offset by net tax payments and other payments related to the divestiture of dialysis clinics and the RCG acquisition as well as by an US tax payment for the years 2000 and 2001. Cash flow before acquisitions and dividends was € 228 million (Q1-3 2005: € 412 million). The acquisition of Renal Care Group was financed through bank debt.

Solid balance sheet structure
Total assets increased by 31 % to € 15,194 million (December 31, 2005: € 11,594 million). In constant currency total assets grew by 36 %. The substantial increase is mainly related to the consolidation of the Renal Care Group. This acquisition was closed effective March 31, 2006. Current assets increased by 15 % to € 4,076 million (December 31, 2005: € 3,531 million). Non-current assets were € 11,118 million (December 31, 2005: € 8,063 million), an increase of 38 %, primarily due to the goodwill resulting from the Renal Care Group acquisition.

Group debt increased to € 6,136 million (December 31, 2005: € 3,502 million) due to the financing of the Renal Care Group acquisition.

As of September 30, 2006, the net debt/EBITDA ratio further improved to 3.2 (March 31, 2006: 3.5; December 31, 2005: 2.3).

Shareholders' equity including minority interest grew 9 % to € 5,583 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 36.7 % (December 31, 2005: 44.2 %).

Employees
As of September 30, 2006, the Group had 104,179 employees worldwide (December 31, 2005: 91,971). The increase of 12,208 employees is primarily due to the acquisition of the Renal Care Group.

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.

Fresenius Biotech has successfully continued its clinical study program: A phase II study on breast cancer started in March 2006. A phase II study for the treatment of gastric cancer started in June 2006. A phase II study on ovarian cancer is planned to start in the first half of 2007. The results from the pivotal malignant ascites phase II/III study are expected by the end of this year.

For the full year 2006, Fresenius Biotech expects an EBIT of approximately € -45 million. Previously, an EBIT in the range of € -45 to -50 million was expected. The amount largely relates to expenses for the clinical study program. In the first nine months of 2006 EBIT at Fresenius Biotech was € -30 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 September 30, 2006, Fresenius Medical Care was serving 161,433 patients in 2,085 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 fully on track
• Outlook for 2006 upgraded

Fresenius Medical Care achieved strong sales growth of 23 % to US$ 6,147 million (Q1-3 2005: US$ 4,999 million). This was driven by both the excellent organic growth of 10 % and the consolidation of the Renal Care Group. Sales in dialysis care increased by 28 % to US$ 4,628 million (Q1-3 2005: US$ 3,610 million). In dialysis products, Fresenius Medical Care achieved sales of US$ 1,519 million (Q1-3 2005: US$ 1,389 million), an increase of 9 % (10 % in constant currency).

In North America, Fresenius Medical Care increased sales by 29 % to US$ 4,367 million (Q1-3 2005: US$ 3,383 million). Organic growth was excellent with 9 %. Sales outside North America ("International") grew by 10 % (11 % in constant currency) to US$ 1,780 million (Q1-3 2005: US$ 1,616 million).

Net income increased by 13 % to US$ 385 million (Q1-3 2005: US$ 339 million). This result includes one-time expenses of US$ 27 million primarily for the refinancing of Fresenius Medical Care debt and the Renal Care Group integration, for 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 was up 20 % to US$ 412 million.

Based on the strong performance in the third quarter of 2006, Fresenius Medical Care upgrades its guidance for the full year 2006. After expecting to report net revenue of about US$ 8.3 billion, Fresenius Medical Care now expects net revenue for 2006 of about US$ 8.4 billion.

Fresenius Medical Care also upgrades its outlook for net income for 2006. After expecting a net income of at least US$ 542 million, the company now expects a net income of at least US$ 557 million, representing an increase of at least 18 % over the corresponding level in 2005.

In order to show the underlying performance of Fresenius Medical Care on a basis comparable with the prior year, the guidance does not take into effect any expected one-time items and the stock option accounting change in the fiscal year 2006. Fresenius Medical Care expects the after tax impact of the one-time items and the stock option accounting change to be about US$ 44 million for the full year 2006.

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 sales and earnings growth continues
• Filaxis acquisition strengthens i.v. drug portfolio
• Earnings outlook for 2006 raised

Fresenius Kabi's sales increased by 13 % to € 1,404 million (Q1-3 2005: € 1,239 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 8 %, in Germany by 4 %. Fresenius Kabi continued its exceptional growth outside Europe and achieved sales growth of 44 % in Asia-Pacific, 31 % in Latin America and 21 % in the other regions. Organic growth in the regions outside Europe was again well into the double digits.

Fresenius Kabi showed an even stronger performance at the EBIT level, with an increase of 25 % to € 213 million (Q1-3 2005: € 170 million). The EBIT margin improved to 15.2 % (Q1-3 2005: 13.7 %). In the third quarter, the EBIT margin reached a new record level of 15.8 %. Net profit rose by 25 % to € 101 million (Q1-3 2005: € 81 million). This already includes one-time expenses of € 11 million for the early redemption of the 2003 Euro Bond.

In September 2006, Fresenius Kabi signed an agreement to acquire 100 % of the shares of Filaxis. This Argentinean company based in Buenos Aires specializes in the development, production and distribution of intravenously administered generic drugs for cancer treatment (cytostatics) and markets its comprehensive product portfolio primarily in Latin America. In 2005 the company achieved sales of approximately € 12 million. The Filaxis acquisition strengthens Fresenius Kabi's portfolio of intravenously administered generic drugs by adding oncology products. Once the respective registration processes are finalized, the Filaxis products will also be marketed outside Latin America through Fresenius Kabi's existing sales and distribution organization. The acquisition still has to be approved by the local antitrust authorities.

Based on its excellent performance in the third quarter, Fresenius Kabi raises its full year 2006 earnings outlook and now expects an EBIT margin in the range of 15.0 to 15.5 %. The company confirms its sales outlook and continues to expect an increase of 11 to 12 % in constant currency.


Fresenius ProServe

Fresenius ProServe is a leading German hospital operator with 56 facilities. Moreover, the company offers engineering and services for hospitals and other health care facilities as well as for the pharmaceutical industry.

• Good operating performance in the hospital operations business
• Strong order intake in the engineering and services business
• Outlook confirmed – Full-year 2006 expected to be at the top end of guidance

Fresenius ProServe's sales grew by 6 % to € 1,526 million (Q1-3 2005 incl. HELIOS Kliniken: € 1,442 million). Organic growth was 3 %. On a comparable basis, EBIT increased by 21 % to € 105 million (Q1-3 2005 incl. HELIOS Kliniken: € 87 million).

Sales in hospital operations (HELIOS Kliniken Group) increased by 5 % to € 1,204 million (Q1-3 2005 incl. HELIOS Kliniken : € 1,152 million). The growth is mainly attributable to the acquisition of HUMAINE Kliniken, which was consolidated as from July 1, 2006. Organic growth was 2 %. EBIT increased to € 94 million, the EBIT margin improved to 7.8 % (Q1-3 2005 incl. HELIOS Kliniken: € 79 million and 6.8 %).

Sales in the engineering and services business (VAMED, Pharmaplan) increased 11 % to € 322 million (Q1-3 2005: € 290 million). EBIT rose to € 14 million (Q1-3 2005: € 9 million). Order intake and order backlog continued to develop very positively. Order intake increased by 22 % to € 291 million (Q1-3 2005: € 239 million). Order backlog rose 21 % to € 437 million as of September 30, 2006 (December 31, 2005: € 360 million).

Fresenius ProServe confirms its outlook but now expects the full-year 2006 to be at the top end of guidance. Guidance calls for revenues to increase by 1 to 3 % before acquisitions (based on 2005 revenues including HELIOS Kliniken of € 2,009 million) and EBIT to rise to € 140 to 150 million (2005 incl. HELIOS Kliniken: € 125 million).

Video Webcast
As part of the publication of our results for the first nine months of 2006, an analyst conference will be held at the Fresenius headquarters in Bad Homburg on October 31, 2006 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.

Fresenius Biotech today announced that the European Commission has granted Orphan Drug Designation for the removab^® (catumaxomab) trifunctional antibody to treat gastric cancer. The Orphan Drug Designation entitles Fresenius to up to 10 years market exclusivity in the EU upon marketing approval.

Results from an ongoing phase II study using catumaxomab in about 50 gastric-cancer patients are expected in the second half of 2007. A previous phase I study in patients with advanced peritoneal carcinomatosis (spread and growth of tumor cells in the abdominal cavity) also included patients with gastric cancer and was completed successfully.

Gastric cancer affects an average of three out of 10,000 people in the EU and accounts for about twelve percent of cancer fatalities around the world, making it the second-leading cause of death caused by cancer. Despite medical advances, gastric cancer patients continue to face a low survival rate. Most patients are first diagnosed at an advanced stage because early symptoms are missing or are very unspecific. In addition, many patients face early relapse after surgical resection of the tumor and subsequent chemotherapy, making new, innovative treatments for gastric cancer a high medical need.

Orphan Drug

The EU grants the Orphan Drug Designation to medicinal products used for rare, life-threatening or chronic diseases that affect no more than five in every 10,000 people in the EU and for which no sufficient effective treatment exists. The European Medicines Agency, the EU pharmaceutical regulatory body, supports businesses that research, develop and market such medicines during the development and regulatory approval process.

At the Extraordinary General Meeting in Frankfurt, Germany, a large majority of Fresenius AG's shareholders approved the Management and Supervisory Boards' proposal to convert the Company's legal form from a German stock corporation (Aktiengesellschaft) into a European Company (Societas Europaea – SE). A share split with capital increase from the Company's funds that will triple the number of shares issued was also approved by a vast majority.

The new legal form reflects the international focus of Fresenius Group's business. Through the conversion, all employees in the European Union and in the signatory states to the European Economic Area may now participate in appointing employee representatives to the Supervisory Board. In addition, Fresenius SE's Supervisory Board will continue to have twelve members. Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG, said: "We are convinced that with the new legal form we can successfully continue our high-quality and efficient corporate governance. The SE particularly facilitates an open and international corporate culture. The conversion of Fresenius AG into a European Company and the share split are two consistent steps in the development of the Company. Combined with our long-term strategy focused on profitable growth, these steps will further strengthen Fresenius."

At the Extraordinary General Meeting, 99.99 percent of the ordinary share capital represented approved the conversion of Fresenius AG into an SE. An SE is a public limited-liability company under European law. The conversion will have no effect on the Company's corporate structure and management organization; the legal and economic identity will be preserved. The conversion becomes effective upon the registration in the commercial register. This is scheduled in the third quarter of 2007 after the completion of the procedure for the involvement of the employees.

99.99 percent of the represented ordinary share capital approved the share split. The subscribed capital of Fresenius AG currently amounts to approximately € 131.7 million. It is divided into 25,725,646 ordinary shares and 25,725,646 preference shares. Through a conversion of capital reserves, the subscribed capital will first be increased to approximately € 154.4 million and then divided into 77,176,938 ordinary shares and 77,176,938 preference shares. The new proportionate amount of the subscribed capital will be 1 € per share. After the share split, every holder of an ordinary share will hold three ordinary shares and every holder of a preference share will hold three preference shares. As a result of the share split, the share price will be reduced arithmetically without affecting the overall value for shareholders. The proposed share split is intended to promote trading activity in Fresenius shares and to increase the shares' attractiveness for a broader group of investors. The share split becomes effective upon the registration in the commercial register, which is expected in the first quarter of 2007.

About 79.95 percent of the ordinary share capital was represented at the Extraordinary General Meeting. Only ordinary shareholders were entitled to vote.

Fresenius today announced encouraging results from a phase II/III pivotal study on malignant ascites in patients with ovarian cancer using the trifunctional antibody removab^® (catumaxomab). The antibody showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (primary endpoint) in the group of patients treated with removab^® was significantly longer compared to the control group and clinically relevant. The median puncture-free survival was 52 days in the removab^® group versus 11 days in the control group (p< 0.0001).

Positive results were also achieved with regard to key secondary endpoints. The median time to the first therapeutic puncture was 71 days (control group: 11 days; p< 0.0001). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric. Also, the EpCAM-positive tumor cell concentration in the ascites fluid decreased significantly in patients treated with removab^® (p< 0.0009). At the same time, an increase in CD45-positive leukocytes was seen. Both results indicate a direct anti-tumor effect of the trifunctional antibody.

Moreover, removab^® showed a very good safety profile. Side effects were mild to moderate 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 without clinical relevance.

"To date, there are only limited therapy options for ovarian cancer patients with malignant ascites. Our data indicate that removab^® could become an important new therapy option for this disease. The positive results of the phase I/II study have been fully confirmed by this pivotal phase II/III trial," said Dr. Thomas Gottwald, President Fresenius Biotech.

The results of this two-arm, randomized, open-label study include treatment data of 129 ovarian cancer patients with ascites. The removab^® arm included 85 patients, of which 73 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.

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

The current phase II/III study with the trifunctional antibody removab^® included a total of 257 patients. The results of the second group (128 patients) with tumor diseases other than ovarian cancer (e.g. gastric cancer) are expected for the first half of 2007.

Conference Call
Fresenius AG will host an conference call today, Monday, December 18, 2006, at 3.30 p.m. CET / 9.30 a.m. EST. The live audio webcast of the conference call can be followed at www.fresenius-ag.com. A replay will be available shortly after the call.

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.

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.

Fresenius ProServe today announced that it 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, a major pharmaceutical company with 22,000 employees worldwide and annual sales of € 4,531 million in 2005.

Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical and GMP-oriented industry worldwide. In 2005, the company had sales of about € 49 million. Pharmaplan currently has about 320 employees, including 130 in Germany. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its business with hospitals and other healthcare facilities. The company offers the full line of services from the planning and construction of hospitals to technical and operational management in its two core areas of hospital management (HELIOS Kliniken) and hospital engineering and services (VAMED). Fresenius ProServe is now well-positioned to successfully participate in the privatization of the hospital market.

NNE is a leading engineering company focused on the biotech and pharma industries. The company is a full-service provider offering conceptual design, validation and operational support. Pharmaplan and NNE's activities and markets complement each other well. The combination of both businesses offers Pharmaplan and its employees exceptional opportunities for future development.

The transaction requires antitrust approval. The Company anticipates the closing of the transaction in the first quarter of 2007. Pharmatec, a Pharmaplan subsidiary with production sites in Dresden, Germany and Ternitz, Austria will not be included in the transaction and will be divested at a later date. Pharmatec manufactures high quality pure steam, pure water and sterilization equipment for the pharmaceutical industry.

Fresenius Biotech and the U.S. Company Enzon Pharmaceuticals, Inc. today announced the recruitment of the first North American patient for a phase II study for approval of ATG-Fresenius S. The polyclonal antibody suppresses the immune reaction against transplanted organs to reduce the risk of rejection. It is already marketed in over 60 countries. The entry of the first patient into the clinical study is an important milestone to introduce this successful product in the North American market. The cooperation partner Enzon is responsible for the clinical development and approval in the U.S., Fresenius Biotech will manufacture and deliver ATG-Fresenius S.

Enzon and Fresenius Biotech also announced today that the U.S. Food and Drug Administration (FDA) granted Fast Track Status in the approval process for the use of ATG-Fresenius S in lung transplantation. The Fast Track process provides a particularly close working relationship with the FDA in order to accelerate the development and approval of pharmaceuticals that are appropriate to treat critically ill patients where adequate therapeutic modalities are not available.

A phase III study using ATG-Fresenius S in renal transplant patients is currently being prepared.

Fresenius Biotech signed a cooperation contract with Enzon Pharmaceuticals in 2003 for the U.S. approval of ATG-Fresenius S. This product is expected to be introduced to the U.S. market in 2007.

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. Further information can be found on the Company's website www.enzon.com.

• Sales: € 7.27 billion, + 8 % constant currency, + 3 % at actual exchange rates
   
• EBIT: € 845 million, + 15 % constant currency, + 8 % at actual exchange rates
   
• Net Income: € 168 million, + 55 % constant currency, + 46 % at actual exchange rates
   
• Strong sales and earnings growth at Fresenius Medical Care
• Excellent business development and significantly improved EBIT margin at Fresenius Kabi
• Fresenius ProServe within expectations
• Strong sales and earnings growth expected for 2005

 

 

Dividend increase proposed
2004 was a very successful year for Fresenius. Based on the Group's excellent financial results, the Management Board will propose to the Supervisory Board a 10 % dividend increase to € 1.35 per ordinary share (2003: € 1.23) and € 1.38 per preference share (2003: € 1.26). This will mark the 12th consecutive year of a dividend increase. The total dividend distribution will be € 55.9 million (2003: € 51.0 million).

Positive Group outlook for 2005
For 2005, Fresenius expects a constant currency sales increase of 6 to 9 %. Net income is projected to grow by 15 to 20 % in constant currency. All business segments are expected to contribute to this increase.

Fresenius is planning to invest in growth in 2005: Investments in property, plant and equipment and intangible assets are projected to increase to approximately € 400 - 450 million; acquisition spending is planned to grow to about € 400 million.

Strong organic sales growth
In 2004, Group sales increased 8 % in constant currency. Organic growth was 6 %, while acquisitions contributed 2 % to the increase in sales. Currency translation effects had an impact of -5 %. At actual exchange rates, sales were € 7,271 million, 3 % above last year's figure of € 7,064 million.

In Europe, sales increased 4 % despite cost cutting measures in the health care sector and price pressure in Germany. North America performed strongly with sales growing 9 % in constant currency. Asia-Pacific, Latin America and Africa achieved double-digit constant currency growth rates.

 

 

 



Excellent earnings growth
Fresenius achieved excellent earnings growth rates: EBITDA rose 11 % in constant currency and 5 % at actual exchange rates to € 1,160 million (2003: € 1,106 million). EBIT rose 15 % in constant currency and 8 % at actual exchange rates to € 845 million (2003: € 781 million). The EBIT margin improved from 11.1 % in 2003 to 11.6 % in 2004.

Net interest expense continued to improve to € -209 million, € 40 million below last year's € -249 million due to a lower debt level as well as enhanced terms. Currency translation effects also had a favorable impact of € 11 million.

In 2004, the tax rate decreased to 39.8 %. The tax rate of 41.9 % in 2003 was mainly due to one-time expenses at Fresenius ProServe.

Minority interests rose to € 215 million (2003: € 194 million). Minority shareholders in Fresenius Medical Care account for 95 % of minority interests.

Net income rose 55 % in constant currency and 46 % at actual exchange rates to € 168 million (2003: € 115 million). Operating income growth at Fresenius Medical Care and Fresenius Kabi was the key driver of this increase. In addition, lower one-time expenses at Fresenius ProServe as well as lower Group interest expenses had a positive impact. Excluding the one-time expenses at Fresenius ProServe in 2003 and 2004 Group net income increased 25 % in constant currency and 18 % at actual exchange rates.

Earnings per ordinary share were € 4.08 from € 2.79 in 2003. Earnings per preference share were € 4.11 (2003: € 2.82). This is an increase of 46 %.
 

Investments on target
In 2004, Fresenius invested € 421 million (2003: € 430 million). Investments for property, plant and equipment and intangible assets decreased to € 308 million (2003: € 339 million) and acquisitions increased to € 113 million (2003: € 91 million).

44 % of the total investments were made both in Europe and North America, 7 % in the Asia-Pacific region and 5 % in Latin America and Africa.
 

Record cash flow
Operating and free cash flow reached new records in 2004: Operating cash flow rose 10 % to € 851 million (2003: € 776 million), mainly due to Group net income growth and improved working capital management. The operating cash flow margin rose to 11.7 % of sales up from 11.0 % in 2003, an increase of 70 basis points. Free cash flow before acquisitions and dividends increased 24 % to € 565 million (2003: € 454 million). After acquisitions and dividends free cash flow rose 31 % to € 353 million (2003: € 269 million) despite increased spending on acquisitions (€ -90 million, net) and dividends (€ -122 million).
 

Solid balance sheet
Total assets decreased 2 % to € 8,188 million (December 31, 2003: € 8,347 million). In constant currency, assets grew by 2 %. Current assets were € 2,755 million (December 31, 2003: € 2,744 million). In constant currency, current assets rose 3 %, primarily driven by the induction of Fresenius Medical Care's receivables securitization program.

Group debt decreased € 413 million to € 2,735 million as of December 31, 2004 (€ 2,824 million in constant currency) compared to € 3,148 million as of December 31, 2003. These figures include liabilities related to the receivables securitization program.

The key ratio net debt/EBITDA improved significantly to 2.2 on December 31, 2004, as a consequence of both EBITDA growth and debt reduction on the back of the excellent cash flow development (December 31, 2003: 2.7).

Shareholders' equity including minority interests rose 4 % to € 3,347 million compared to € 3,214 million on December 31, 2003 (constant currency: +9 %). The equity ratio including minority interests improved to 40.9 % (December 31, 2003: 38.5 %).

 

Number of employees slightly increased
As of December 31, 2004, Fresenius had 68,494 employees worldwide, an increase of 3 % (December 31, 2003: 66,264).
 

 

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 suppress graft rejection following an organ transplantation.

In cancer therapy, final results are available of a phase I study to determine dosage, safety and tolerability of the antibody removab^® in peritoneal carcinomatosis as well as from a phase I study for the treatment of breast cancer using the antibody rexomun^®. The clinical results of the final reports will be published at the 41st ASCO (American Society of Clinical Oncology) Annual Meeting in May 2005. Based on the encouraging results Fresenius Biotech is planning a phase II study for the treatment of breast cancer and a phase II study for the treatment of gastric cancer.

Preliminary results are available for a phase I/II cell therapy study that investigated the treatment of patients with end-stage HIV infection. The results show that the therapy is well tolerated and safe. The clinical development program is planned to continue in the current year.

In 2004, Fresenius Biotech's EBIT was € -28 million (2003: € -19 million). The EBIT development was within our expectations and is a result of the increased research and development spending. For 2005, Fresenius Biotech‘s EBIT is expected to be in the range of € -35 million to € -40 million, largely due to the expanded clinical study program.

The business segments

Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and services for patients with chronic kidney failure. As of December 31, 2004, Fresenius Medical Care treated about 124,400 patients (+4 %) in 1,610 dialysis clinics (+3 %), the number of treatments rose by 5 % to about 18.8 million.

• Strong growth in sales and earnings
   
• Excellent sales development in dialysis care in North America and in dialysis products and dialysis care in the international segment
   
• Outlook for 2005: significant growth in sales and earnings

Fresenius Medical Care achieved excellent sales growth in 2004 of 13 % to $ 6,228 million (2003: $ 5.528 million). In constant currency, sales rose 10 %. Organic sales growth was 6 %.

In North America, the company's biggest market, Fresenius Medical Care posted exceptionally good performance as sales rose 9 % to $ 4,216 million (2003: $ 3,855 million). Dialysis care sales grew 11 % to $ 3,795 million. Fresenius Medical Care performed about 12.9 million dialysis treatments in 2004, 4 % more than in the previous year. Sales of dialysis products (including sales to our own dialysis clinics) increased 1 % to $ 793 million.

Sales outside North America (the "International" segment) rose 20 % (constant currency: 11 %) to $ 2,012 million (2003: $ 1,673 million). Sales of dialysis products (including sales to our own dialysis clinics) increased 16 % to $ 1,450 million. Dialysis care sales grew 28 % to $ 706 million. In the international segment, Fresenius Medical Care operates 480 dialysis clinics. The Company performed 5.9 million dialysis treatments (+8 %).

Fresenius Medical Care significantly improved earnings in 2004. EBIT increased 13 % to $ 852 million (2003: $ 757 million), the operating margin was 13.7 %. On a comparable basis (excl. the new accounting regulation FIN 46R) the operating margin would have been 13.8 % (2003: 13.7 %). Net income increased 21 % to $ 402 million.

For the year 2005, Fresenius Medical Care expects currency-adjusted sales growth between 6 and 9 % and net income growth in the low double-digit range.

 

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

 

 

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

 

 

• Profitability significantly increased; EBIT margin of 11.8 % achieved in 2004
   
• Good organic growth of 5 %; continued double-digit growth in developing markets
   
• Outlook for 2005: significant growth in earnings expected

Sales at Fresenius Kabi rose 2 % to € 1,491 million in 2004 (2003: € 1,463 million). The company achieved a good organic sales increase of 5 %. Currency translation reduced sales by 1 %, divestments by 2 %. Sales in Europe were impacted by a 6 % decrease in Germany due to cost cuts and price pressure in the health care sector. Outside of Germany, Fresenius Kabi showed an excellent performance in Europe with organic growth of 6 %. Outstanding sales growth was achieved in the Asia-Pacific and Latin America regions posting organic increases of 22 % and 11 %, respectively.

In 2004, Fresenius Kabi reached new records in earnings. EBIT rose 20 % to € 176 million (2003: € 147 million). Besides the good progress made in international markets, cost optimization and efficiency increases, especially in production, had a positive effect. The EBIT margin was 11.8 %, an increase of 180 basis points over 10.0 % of the previous year.

Fresenius Kabi foresees continued momentum for 2005. Sales are expected to increase by about 10 % in constant currency including the Labesfal acquisition. The Asia-Pacific and Latin America regions are projected to continue their growth pattern. In parallel, Fresenius Kabi expects further optimize its cost base. As a consequence of both developments, the company is confident to post yet another significant earnings growth in 2005. The EBIT margin including the Labesfal acquisition is projected to increase to ≥ 13 %.
 

Fresenius ProServe

Fresenius ProServe offers services for international health care systems, including hospital management, the planning and construction of hospitals and pharmaceutical and medical-technical production plants.

• Earnings within expectations
   
• Organic sales growth of 10 % achieved
   
• Strategic reorientation and clear focus on core activities
   
• Outlook for 2005: continued improvement in earnings

Fresenius ProServe simplified its organizational structure in 2004 and focused on three core activities: hospital management in Germany (Wittgensteiner Kliniken), hospital engineering and services (VAMED) and engineering and services for the pharmaceutical industry (Pharmaplan). The Company divested its nursing home activities and closed its international hospital management activities. Efforts to improve earnings at Wittgensteiner Kliniken were continued according to plan.

Fresenius ProServe increased sales in 2004 to € 813 million (2003: € 742 million). The increase in sales was solely achieved through organic growth and resulted from the positive development of the hospital engineering and services business.

EBIT at Fresenius ProServe was € 9 million (2003: € -19 million), including one-time expenses of € 8 million before taxes (2003: € 34 million). Excluding one-time expenses, Fresenius ProServe achieved an EBIT of € 17 million (2003: € 15 million).

Order intake at the project businesses of VAMED and Pharmaplan was € 244 million in 2004 (2003: € 278 million). This decrease is mainly due to delayed closing of contracts as well as a continued investment caution in the pharmaceutical industry.

Fresenius ProServe expects continued earnings improvement in 2005. Projected EBIT will be between € 20 million and € 25 million. Organic sales growth is expected to be in the range of 5 to 8 % resulting mainly from the hospital engineering and services business.


Video Webcast
As part of the publication of our 2004 results, an analyst conference will be held on February 24, 2005 at 1:30 p.m. CET. We sincerely invite all investors to follow the live video broadcast of the conference over the Internet at www.fresenius-ag.com /Investor Relations / Presentations. Following the conference, a recording of the conference will be available as video-on-demand.


Annual report
The 2004 Annual Report will be available at the end of March 2005 on the Internet at www.fresenius-ag.com / Investor Relations / Publications.