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

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


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

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


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

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

Glossary
Epithelial tumors
: tumors that result from degenerated cells of epithelial origin.

 

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

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

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

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

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

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

This announcement is for distribution only to persons who (i) have professional experience in matters relating to investments falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (as amended, the "Financial Promotion Order"), (ii) are persons falling within Article 43 of the Financial Promotion Order (iii) are persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations etc") of the Financial Promotion Order, (iv) are outside the United Kingdom, or (v) are persons to whom this announcement can otherwise be lawfully communicated or caused to be communicated (all such persons together being referred to as "relevant persons").

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

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

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

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

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

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

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

This release contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to various factors, e.g., changes in the business, economic and competitive environment, 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 it has successfully priced its €1 billion offering of Senior Notes issued by its wholly-owned subsidiary Fresenius Finance B.V. (the "Issuer").

The issue includes two tranches:

  • €500 million principal amount, at an issue price of 99.541 %, bearing interest at 5.0 % for the Senior Notes due 2013, non-callable,
  • €500 million principal amount, at an issue price of 99.314 %, bearing interest at 5.5 % for the Senior Notes due 2016, callable from 2011 by the Issuer.

The net proceeds from the Senior Notes offering, along with the proceeds from the Company's recent capital increase, will finance the acquisition of HELIOS Kliniken GmbH and the repurchase of a portion of the Issuer's 7.75 % Series A Senior Notes and will also be used for general corporate purposes. The offering of Senior Notes will be closed and funded on January 20, 2006.

The transaction was well received by investors, being substantially oversubscribed.

Credit Suisse First Boston (Europe) Limited and Morgan Stanley & Co. International Limited acted as Joint Book-Running Lead Managers and Dresdner Kleinwort Wasserstein acted as Joint Lead Manager of the Senior Notes offering.

In conjunction with the above, Fresenius AG priced the offer to repurchase its €300 million aggregate principal amount of the Issuer's outstanding 7.75 % Series A Senior notes due 2009, listed on the Luxembourg Stock Exchange. Fresenius repurchases €212,079,000 aggregate principal amount of Notes, representing a participation rate for the tender offer of approx. 71 %. The repurchase price is 105.168 %, or €1,051.68 per €1,000 nominal value of Notes, plus accrued interest from the last interest payment date.

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

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

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

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

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

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

For further information please see the PDF-file.

  • Sales € 7.9 billion,
    + 8 % at actual rates and in constant currency
  • EBIT € 969 million,
    + 15 % at actual rates , + 14 % in constant currency
  • Net income € 222 million,
    + 32 % at actual rates, + 31 % in constant currency
  • Strong sales and earnings growth at Fresenius Medical Care
  • Excellent business performance and EBIT margin increase to 13.9 % at Fresenius Kabi
  • Fresenius ProServe within expectations; order intake in project business +40 %
  • Strong sales and earnings growth expected for 2006

Dividend increase proposed
2005 was a very successful year for Fresenius. Based on the Group's excellent financial results, for the 13th consecutive year the Management Board will propose to the Supervisory Board a dividend increase to € 1.48 per ordinary share (2004: € 1.35) and € 1.51 per preference share (2004: € 1.38). As the 9.4 million new shares from the capital increase in December 2005 are fully entitled to the 2005 dividend, the total dividend distribution will be € 75.8 million (2004: € 55.9 million).


Positive Group outlook for 2006
For 2006, Fresenius expects to achieve sales growth of about 30 % to approximately € 10.5 billion including Renal Care Group and an organic growth of 5-6 %.

Net income is projected to grow by more than 30 % in constant currency. The net income guidance already includes an amount of approx. € 30 million (after tax) associated with expected one-time expenses for the integration of Renal Care Group and the refinancing of debt as well as for costs related to the change of accounting principles for stock options. Due to the higher number of shares issued in December 2005, earnings per share are projected to increase by approximately 10 % in constant currency.

Investments in property, plant and equipment and intangible assets are projected to increase to approximately € 550 - 600 million.


Strong organic sales growth
In 2005, Group sales increased 8 % to € 7,889 million (2004: € 7,271 million). Organic growth contributed 7 % and acquisitions 2 %. Divestments had a -1 % effect on sales. Currency translation had hardly any impact.

Remarkable sales growth of 8 % was achieved each in our main markets North America and Europe. Latin America with sales growth of 30 % and Africa with 16 % performed strongly. In Asia-Pacific, Fresenius Medical Care and particularly Fresenius Kabi achieved an excellent sales increase. Sales of Fresenius ProServe, however, decreased due to the lower project volume in this region.

Sales contribution of the three business segments:

Excellent earnings growth
EBITDA increased 11 % to € 1,289 million (2004: € 1,160 million). Group EBIT rose 15 % at actual rates and 14 % in constant currency to € 969 million (2004: € 845 million). The Group EBIT margin improved to 12.3 % (2004: 11.6 %).

Group net interest improved to € -203 million (2004: € -209 million) primarily as a result of a lower debt level in combination with lower interest rates from various refinancing measures.

The tax rate for 2005 was 38.9 % (2004: 39.8 %).

Minority interest was € 246 million (2004: € 215 million). 96 % was attributable to the minority interest of Fresenius Medical Care.

Group net income grew significantly by 32 % at actual rates and by 31 % in constant currency to € 222 million (2004: € 168 million). Key growth drivers were the excellent operating results of Fresenius Medical Care and Fresenius Kabi as well as reduced financing costs and a lower tax rate.

Earnings per ordinary share rose to € 5.28 (2004: € 4.08) while earnings per preference share rose to € 5.31 (2004: € 4.11). This is an increase of 29 % for both share classes. The average number of shares grew to 41.88 million primarily due to the capital increase.


Investments at record level
Total Group investments increased to € 2.25 billion (2004: € 421 million). € 1.89 billion was spent on acquisitions (2004: € 113 million), including € 1.5 billion for HELIOS. € 353 million was spent for property, plant and equipment and intangible assets (2004: € 308 million).


Solid cash flow performance
Fresenius achieved a good operating cash flow of € 780 million (2004: € 851 million). Key drivers were the significant improvement in earnings whereas income tax payments of Fresenius Medical Care for prior years had a negative effect. Cash flow before acquisitions and dividends was € 449 million (2004: € 565 million). Dividends of € 132 million and about 20 % of the 2005 acquisitions (net) were financed through cash flow. The balance was financed through bank debt and the capital increase.


Solid balance sheet structure
Total assets increased 42 % to € 11,594 million (December 31, 2004: € 8,188 million). In constant currency, total assets grew 33 %. The substantial increase in assets is acquisition-related, mainly due to the HELIOS acquisition. Current assets increased 28 % to € 3,531 million (December 31, 2004: € 2,755 million). In constant currency, current assets grew 21 %. Non-current assets were € 8,063 million (2004: € 5,433 million), a constant currency increase of 39 %. This was primarily due to an increase in goodwill.

Group debt increased 28 % to € 3,502 million (December 31, 2004: € 2,735 million) due to acquisition financing. In constant currency, the increase was 24 %.

Including HELIOS's EBITDA contribution the net debt/EBITDA ratio was 2.3 (December 31, 2004: 2.2).

Shareholders' equity including minority interest was € 5,130 million, a 40 % constant-currency increase (December 31, 2004: € 3,347 million). This was due to the excellent earnings development and the proceeds from the capital increase. The equity ratio including minority interest improved to 44.2 % (December 31, 2004: 40.9 %).


Employee numbers continue to grow
As of December 31, 2005, the Group had 91,971 employees worldwide (December 31, 2004: 68,494). The increase of 23,477 employees is principally due to the acquisition of HELIOS.


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 the field of the trifunctional antibody therapies for the treatment of cancer, Fresenius Biotech expects results from the clinical study for ovarian cancer in the first half of 2006. The results from the malignant ascites and malignant pleural effusion studies are expected in the second half of 2006. Following the positive results from two phase I studies for the treatment of peritoneal carcinomatosis and breast cancer, phase II studies for the treatment of gastric cancer and breast cancer are being prepared.

In 2005, Fresenius Biotech's EBIT was € -40.6 million (2004: € -28 million). This development was within our expectations and is a result of the increased research and development spending. For 2006, Fresenius Biotech‘s EBIT is expected to be in the range of € -45 to -50 million, largely due to the 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 December 31, 2005, Fresenius Medical Care was serving approximately 131,450 patients (+6 %) in 1,680 dialysis clinics (+4 %). The company delivered about 19.7 million treatments in 2005 (+5 %).
 

  • Strong sales and earnings growth continued
  • Transformation into KGaA and conversion of preference shares successfully completed
  • Closing of the Renal Care Group (RCG) acquisition expected in 1st quarter of 2006

Fresenius Medical Care achieved sales growth of 9 % to US$ 6,772 million (2004: US$ 6,228 million). In constant currency, sales rose 8 %. Organic growth was 7 %.

In North America, Fresenius Medical Care achieved a sales increase of 8 % to US$ 4,577 million (2004: US$ 4,248 million). Sales outside North America ("International") showed an even stronger growth of 11 % to US$ 2,195 million (2004: US$ 1,980 million).

Sales in dialysis care increased 8 % to US$ 4,867 million (2004: US$ 4,501 million). In dialysis products, Fresenius Medical Care achieved sales growth of 10 % to US$ 1,905 million (2004: US$ 1,727 million).

EBIT rose 10 % to US$ 939 million (2004: US$ 852 million) and the EBIT margin was 13.9 % (2004: 13.7 %). This figure includes one-time costs of US$ 22 million associated with the transformation of Fresenius Medical Care's legal form into a KGaA and related legal fees and costs concerning the settlement of shareholder litigation. Net income including one-time costs grew by 13 % to US$ 455 million in 2005 (2004: US$ 402 million).

For the full year 2006, Fresenius Medical Care expects revenue growth at constant currencies of approximately 25 % on a pro forma basis, giving effect to the RCG merger as compared to 2005 reported revenues. Pro forma amounts assume consolidation of RCG's operations into Fresenius Medical Care for the full twelve months of 2006. For the full year 2006, Fresenius Medical Care expects to report revenue of more than US$ 8 billion.

Fresenius Medical Care's projected net income growth on a pro forma basis for 2006 is expected to be between 10 and 15 %, based on the US$ 472 million net income excluding one-time costs, achieved in 2005.

Guidance provided by the Fresenius Medical Care does not take into effect any expected one-time items and the change of accounting principle for stock options - SFAS 123(R) in the fiscal year 2006. Fresenius Medical Care expects the after tax impact of the one-time items and SFAS 123(R) to be around US$ 50 million.

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.

  • Excellent EBIT margin of 13.9 % achieved – guidance exceeded
  • Strong organic growth of 7 %
  • Outlook 2006: significant growth in sales and earnings expected

Fresenius Kabi's sales rose 13 % to € 1,681 million (2004: € 1,491 million). The company achieved excellent organic growth of 7 %. Acquisitions, primarily Labesfal, contributed 5 % to sales. Divestments had a -1 % effect on sales. Currency translation added 2 % to growth. Constant currency growth of 11 % exceeded the company's earlier guidance.

Sales in Europe (excluding Germany) increased 15 % with acquisitions making a significant contribution. Sales in Germany rose 1 %. Fresenius Kabi continued to grow exceptionally outside of Europe and achieved sales growth of 17 % in Asia-Pacific, 28 % in Latin America and 13 % in Africa.

Fresenius Kabi achieved a new record EBIT with a 33 % increase to € 234 million (2004: € 176 million). The EBIT margin improved by 210 basis points to 13.9 % (2004: 11.8 %). Key drivers were the strong sales growth, further cost optimization and improved efficiency, especially in production.

Fresenius Kabi expects the positive development to continue in 2006. Sales are expected to increase about 10 % in constant currency. The Asia-Pacific and Latin America regions are projected to continue their growth pattern. The first-time consolidation of Clinico and Pharmatel will also have a positive effect on sales. Pharmatel is an Australian company, in which Fresenius Kabi increased its stake from 25.1 % to 50.1 % at the beginning of 2006. The projected sales growth combined with cost optimizations will result in a significant earnings improvement in 2006. Fresenius Kabi's EBIT-margin is projected to increase to 14.5 - 15.0 %.


Fresenius ProServe
Fresenius ProServe offers services for the international health care sector including hospital operations, technical management and hospital planning and construction as well as planning and construction of pharmaceutical and medical-technical production sites.
 

*incl. HELIOS

  • Acquisition of HELIOS Kliniken successfully closed
  • 2005 sales and earnings within expectations
  • Outlook 2006: Further positive development expected

In 2005, Fresenius ProServe achieved sales of € 809 million (2004: € 813 million). On a comparable basis (excluding the nursing home business sold in 2004 and the discontinued international hospital management business), sales rose 5 %, within the company's guidance of 5-8 %. Sales growth of 2 % to € 350 million was achieved in the hospital operations business (Wittgensteiner Kliniken). In the hospital engineering and services business (VAMED), sales rose by 7 % to € 377 million. In the pharmaceutical engineering and services business (Pharmaplan), order intake improved and resulted in a sales increase of 4 % to € 82 million.

EBIT was € 20 million (2004: € 9 million; before one-time expenses: € 17 million), in line with the company's expectations.

Order intake and order backlog at the project business developed very positively: Order intake increased 40 % to € 341 million (2004: € 244 million). Order backlog rose 7 % to € 360 million (December 31, 2004: € 335 million).

The acquisition of HELIOS was completed at the end of 2005. The company was consolidated as of December 31, 2005 in the Group's balance sheet.

HELIOS developed positively in 2005 and met its communicated targets. Sales reached € 1,200 million. EBIT was € 105 million, the EBIT margin therefore 8.8 %. Net income amounted to € 67 million. The figures are in accordance with US-GAAP as followed by the Fresenius Group. In 2004, HELIOS had prepared its financial statements according to International Finance Reporting Standards (2004 IFRS: sales € 1,161 million, EBIT € 95 million, net income € 66 million).

Through the acquisition of HELIOS, Fresenius ProServe has become a strong third business segment within the Fresenius Group. Including HELIOS for the full 2005 financial year, sales at Fresenius ProServe were € 2,009 million and EBIT € 125 million.

For 2006, Fresenius ProServe expects an organic sales growth of 1 to 3 % based on 2005 sales of € 2,009 million. Projected EBIT will be between € 140 million and € 150 million.


Video Webcast
As part of the publication of our 2005 results, an analyst conference will be held on February 22, 2006 at 1:30 p.m. CET (7.30 a.m. EST). We 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 2005 Annual Report will be available on March 20, 2006 on the Internet at www.fresenius-ag.com / Investor Relations / Publications.

This release contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to various factors, e.g., changes in the business, economic and competitive environment, 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 Finance B.V., a wholly-owned subsidiary of Fresenius AG, has given notice to exercise its option to redeem the remaining € 87,921,000 outstanding amount of its 7.75% Series A Senior Notes due 2009 (ISIN XS0167402840/XS0167402501), listed on the Luxembourg Stock Exchange.

The repurchase price is 103.875 % or € 1,038.75 per € 1,000 nominal value of the Notes, plus accrued interest. The redemption will become effective on April 30, 2006 and payment will be made on May 2, 2006.

In January 2006, € 212,079,000 of principal amount of Series A Senior Notes were already repurchased in a tender offer. Both redemption exercises are financed by the excess proceeds of the new issue of € 1 billion Senior Notes, which was executed in January 2006.

This announcement contains forward-looking statements which are subject to certain risks and uncertainties. Future results could differ materially from the results currently expected, as the result of various risk factors such as, for example, changes in the business, economic and competitive situation, changes in the law, the results of clinical studies, exchange rate fluctuations, uncertainties with regard to legal disputes or investigative proceedings and the availability of financial resources. Fresenius undertakes no responsibility for updating the forward-looking statements in this announcement.

Fresenius Biotech and Nabi Biopharmaceuticals (Nasdaq: NABI) have signed an agreement to advance the ongoing clinical development of the immuno-suppressant ATG-Fresenius S for the U.S. market. The agreement also grants Nabi Biopharmaceuticals exclusive sales and distribution rights in North America for ATG-Fresenius S for up to 15 years following approval by the U.S. Food and Drug Administration (FDA). Nabi Biopharmaceuticals will be responsible for the clinical development, regulatory approval, marketing and sales in the U.S. Fresenius Biotech will receive milestone and licensing payments and supply ATG-Fresenius S to Nabi Biopharmaceuticals.

Dr. Thomas Gottwald, CEO of Fresenius Biotech: "We are very pleased to have found an experienced partner in transplantation medicine that can continue and expand the current clinical development program of ATG-Fresenius S. Nabi Biopharmaceuticals created what today is a very favorable commercial product in Nabi-HB, the current gold standard in the U.S for prevention of re-infection with hepatitis B in liver transplant patients."

In January of this year, Fresenius Biotech announced that it would continue the clinical development program with another partner after Enzon Pharmaceuticals had terminated its Licensing Agreement with Fresenius Biotech. Enzon had decided to redirect its research and development investments.

ATG-Fresenius S is an immuno-suppressive polyclonal antibody and is used for the induction of immuno-suppression and rescue therapy of acute rejection following solid organ transplantation. Fresenius Biotech currently markets the drug in more than 60 countries.


About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. The company has three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [Hepatitis B Immune Globulin (Human)], and Aloprim™ (allopurinol sodium) for Injection. Nabi Biopharmaceuticals is focused on developing products that address unmet medical needs and offer commercial opportunities in its core business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology) and nicotine addiction. For a complete list of pipeline products, please go to: http://www.nabi.com/pipeline/index.php. The company is headquartered in Boca Raton, Florida. For additional information about Nabi Biopharmaceuticals, please visit its website at: http://www.nabi.com.

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

  • Sales: Euro 2.4 billion, + 34 % at actual rates,+ 27 % in constant currency
  • EBIT: Euro 291 million, + 37 % at actual rates , + 31 % in constant currency
  • Net income: Euro 65 million, + 41 % at actual rates, + 35 % in constant currency
  • All business segments above budget
  • Excellent business performance at Fresenius Medical Care
  • Record sales and earnings at Fresenius Kabi
  • Fresenius ProServe with good earnings development in all segments
  • Overproportional share of expected one-time expenses already included in the first quarter 2006

Group outlook for 2006 confirmed
Based on the strong financial results for the first quarter, Fresenius fully confirms its positive outlook for 2006 and expects an increase of about 30 % in Group sales to approximately Euro 10.5 billion.

Net income is projected to grow by more than 30 % in constant currency. The net income guidance already includes an amount of approximately Euro 30 million (after tax) associated with expected one-time expenses as well as with expenses related to the stock option accounting change.

Investments in property, plant and equipment and intangible assets are projected to increase to approximately Euro 550 to 600 million.

Strong organic sales growth
In the first quarter 2006, Group sales increased by 34 % to Euro 2,388 million (Q1 2005: Euro 1,787 million). Organic growth was excellent, contributing 9 % to revenue growth. Acquisitions contributed 18 %, in particular due to the first-time consolidation of HELIOS Kliniken in the income statement. Currency translation effects contributed by 7 % to revenue growth.

Remarkable sales growth of 9 % in constant currency was achieved in North America. In Europe, sales rose significantly due to the first-time consolidation of HELIOS Kliniken. Organic growth was 7 %. Additionally, excellent growth rates were achieved in the emerging markets, with constant-currency sales up 27 % in Asia-Pacific, 26 % in Latin America and 16 % in Africa.
 

 Sales contribution of the three business segments:

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

Strong earnings growth
EBITDA increased by 33 % in actual rates or 27 % in constant currency to Euro 377 million (Q1 2005: Euro 284 million). Group EBIT rose 37 % at actual rates and 31 % in constant currency to Euro 291 million (Q1 2005: Euro 212 million). All business segments achieved an excellent EBIT growth. The Group EBIT margin improved to 12.2 % (Q1 2005: 11.9 %).

Group net interest was Euro -84 million (Q1 2005: -47 million). This includes one-time expenses of Euro 25 million associated with the refinancing of Group debt.

The tax rate for the first quarter of 2006 was 36.7 % (Q1 2005: 39.4 %).

Minority interest was Euro 66 million (Q1 2005: Euro 54 million). 93 % was attributable to the minority interest of Fresenius Medical Care.

Group net income grew significantly by 41 % at actual rates and 35 % in constant currency to Euro 65 million (Q1 2005: Euro 46 million). This result includes one-time expenses of approximately Euro 13 million primarily for the refinancing of debt as well as for expenses related to the stock option accounting change.

Earnings per ordinary share rose to Euro 1.28 (Q1 2005: Euro 1.11) while earnings per preference share rose to Euro 1.29 (Q1 2005: Euro 1.12). This is an increase of 15 % for both share classes (9 % in constant currency). Primarily due to the capital increase in December 2005 the average number of shares grew to 50,785,222.

Investments
Due to the acquisition of Renal Care Group, Group investments in the first quarter of 2006 increased to Euro 3.39 billion (Q1 2005: Euro 229 million). Euro 3.29 million was spent on acquisitions (Q1 2005: Euro 181 million). Euro 100 million was spent for property, plant and equipment and intangible assets (Q1 2005: Euro 48 million).

Cash flow
Operating cash flow increased by 11 % to Euro 186 million (Q1 2005: Euro 168 million). Key drivers were the significant improvement in earnings whereas the increase in working capital due to business expansion had a negative effect. Cash flow before acquisitions and dividends was Euro 91 million (Q1 2005: Euro 126 million). The acquisition of Renal Care Group was financed through bank debt.

Solid balance sheet structure
Total assets increased by 35 % to Euro 15,687 million (December 31, 2005: Euro 11,594 million). In constant currency, total assets grew 37 %. The substantial increase in assets 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 28 % to Euro 4,506 million (December 31, 2005: Euro 3,531 million). Non-current assets were Euro 11,181 million (Q1 2005: Euro 8,063 million), an increase of 39 %. This was primarily due to an increase in goodwill.

Group debt increased to Euro 6,657 million (December 31, 2005: Euro 3,502 million) due to financing of the Renal Care Group acquisition.

Including Renal Care Group's EBITDA contribution the net debt/EBITDA ratio was 3.5 (December 31, 2005: 2.3).

Shareholders' equity including minority interest was Euro 5,546 million, 8 % above the figure of Euro 5,130 million as of December 31, 2005. This was due to the very good earnings development and the first-time consolidation of the Renal Care Group. As a result of the financing of the Renal Care Group acquisition the equity ratio (including minority interests) decreased to 35.4 % (December 31, 2005: 44.2 %).

Employee numbers exceeds 100,000
As of March 31, 2006, the Group had 100,934 employees worldwide (December 31, 2005: 91,971). The increase of 8,963 employees is principally 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: In the field of the trifunctional antibody therapies for the treatment of cancer, Fresenius Biotech expects results from the ovarian cancer study in June 2006. The results from the malignant ascites study are expected at the end of this year.

A phase II study on malignant ascites has started in the US as planned. The U.S. Food and Drug Administration (FDA) granted Fast Track Status in the approval process for this indication. The Fast Track process provides a particularly close working relationship with the FDA in order to accelerate the development and approval of pharmaceuticals to treat potentially fatal diseases for which adequate therapies are not yet available.

A phase II study on breast cancer has 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 is scheduled to begin mid-2006.

For the full year 2006, Fresenius Biotech continues to expect an EBIT in the range of Euro -45 to -50 million, largely due to the 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 March 31, 2006, Fresenius Medical Care (incl. Renal Care Group and after divestitures) was serving approximately 158,700 patients in 2,045 dialysis clinics.
 

* before one-time expenses and expenses related to the stock option accounting change

  • Excellent sales and earnings growth
  • Renal Care Group acquisition successfully completed at the end of March 2006
  • Outlook confirmed

Fresenius Medical Care achieved sales growth of 9 % to US$ 1,747 million (Q1 2005: US$ 1,609 million). In North America, Fresenius Medical Care increased sales by 10 % to US$ 1,194 million (Q1 2005: US$ 1,088 million). Sales outside North America ("International") grew by 6 % (12 % in constant currency) to US$ 553 million (Q1 2005: US$ 521 million). Sales in dialysis care increased by 9 % to US$ 1,273 million (Q1 2005: US$ 1,162 million). In dialysis products, Fresenius Medical Care achieved sales growth of 11 % in constant currency to US$ 474 million (Q1 2005: US$ 447 million).

Net income increased by 8 % to US$ 116 million (Q1 2005: US$ 107 million). Net income includes US$ 11 million of costs for the stock option accounting change and for one-time expenses related to the change of the company's legal form and the refinancing of Fresenius Medical Care debt. Excluding the above one-time expenses net income was up 18 % to US$ 127 million.

For the year 2006, Fresenius Medical Care confirms its outlook and expects to report revenue of more than US$ 8 billion. The company expects reported net income for 2006 to be between US$ 515 million and US$ 535 million. Guidance provided by the company does not take into effect any expected one-time items and the stock option accounting change - SFAS 123(R) in the fiscal year 2006. Fresenius Medical Care expects the after tax impact of the one-time items and SFAS 123(R) to be around US$ 60 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 in all regions
  • Excellent EBIT growth and further margin improvement achieved
  • Outlook for 2006 confirmed

Fresenius Kabi's sales increased by 17 % to Euro 466 million (Q1 2005: Euro 398 million). The company achieved strong organic growth of 9 %, partially supported by an increased number of working days compared to the first quarter of 2005. Acquisitions, primarily Clinico and the first-time consolidation of Pharmatel, contributed 5 % to sales. Currency translation added 3 % to growth.

Sales in Europe (excluding Germany) increased by 10 % in constant currency. Sales in Germany rose 6 %. Fresenius Kabi continued to grow exceptionally outside of Europe and achieved a constant-currency sales growth of 38 % in Asia-Pacific, 25 % in Latin America and 40 % in Africa.

Fresenius Kabi showed an excellent performance at the EBIT level, with an increase of 31 % to Euro 68 million (Q1 2005: Euro 52 million). The EBIT margin improved to 14.6 %, which is fully in line with the forecast for the full year. Net profit rose to Euro 26 million versus Euro 24 million in Q1 2005. This includes one-time expenses of Euro 8 million for the redemption of the 2003 Eurobond.

Fresenius Kabi confirms its outlook for the full year 2006: Sales are expected to increase about 10 % in constant currency due to strong organic sales growth and the first-time consolidation of Clinico and Pharmatel. Cost reductions in production combined with the projected sales growth will result in a significant earnings improvement in 2006. Fresenius Kabi's EBIT-margin is projected to increase to 14.5 to 15.0 %.

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

  • Sales and earnings get off to a good start in all segments
  • Business performance fully in line with forecast
  • Outlook for 2006 confirmed

In the first quarter of 2006, Fresenius ProServe achieved excellent financial results. Sales grew by 1 % to Euro 476 million (Q1 2005: incl. HELIOS Kliniken: Euro 469 million; as reported: Euro 171 million). Organic growth was 3 %.

EBIT increased by 11 % to Euro 30 million (Q1 2005: incl. HELIOS Kliniken: Euro 27 million, as reported: Euro 3 million;).

For greater transparency we are reporting sales and EBIT of the hospital operations business and the engineering & services business separately in future. The hospital operations business comprises the HELIOS Kliniken Group including Wittgensteiner Kliniken. The engineering & services business covers the activities of VAMED and Pharmaplan.

Sales in hospital operations (HELIOS Kliniken incl. Wittgensteiner Kliniken) were at previous year's level with Euro 383 million. Organic growth was 2 %. EBIT increased to Euro 27 million in Q1 2006. The EBIT margin improved to 7.0 % (Q1 2005 incl. HELIOS Kliniken: Euro 25 million, EBIT margin: 6.5 %).

In March 2006, HELIOS Kliniken has agreed to acquire a majority stake in HUMAINE Kliniken GmbH. HUMAINE operates six acute and post acute care hospitals with a total of 1,850 beds, thereof 1,530 in the acute care area. The group achieved sales of Euro 197 million and operating profit (EBIT) of Euro 14 million. The transaction is expected to be completed in mid-2006. The acquisition of HUMAINE will be accretive to Fresenius Group's earnings per share in the fiscal year 2006.

Sales in the engineering & services business (VAMED, Pharmaplan) increased by 8 % to Euro 93 million (Q1 2005: Euro 86 million). EBIT was up 67 % to Euro 5 million (Q1 2005: Euro 3 million). Order intake and order backlog continued to develop very positively: Order intake increased by 40 % to Euro 66 million in Q1 2006 (Q1 2005: Euro 47 million). Order backlog rose 2 % to Euro 367 million as of March 31, 2006 (Q1 2005: Euro 360 million).

For the full year 2006 Fresenius ProServe expects sales growth of 1 to 3 % before acquisitions, based on 2005 revenues including HELIOS of Euro 2,009 million. EBIT is forecast to rise to Euro 140 to150 million (2005 incl. HELIOS: Euro 125 million).

Conference Call
As part of the publication of our results of the first quarter 2006, a conference call will be held on May 3, 2006 at 2.00 p.m. CEDT (8.00 a.m. EDT). We invite all investors to follow the conference call over the Internet under Investor Relations / Presentations. Following the conference, a recording of the call will be available as video-on-demand.

Quarterly report
The report for the first quarter 2006 will be available on May 15, 2006 on the Internet at www.fresenius-ag.com / Investor Relations / Publications.

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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