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The European Commission has approved Removab (catumaxomab) for the treatment of malignant ascites with immediate effect. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites and provides an important new therapy approach. The approval is based on the results of a large international phase II/III pivotal study which demonstrated a statistically significant improvement of the primary endpoint puncture-free survival. Patients receiving Removab had a four-fold increase in puncture-free survival over a therapy with puncture alone.

The European Commission's decision will apply to all EU member states. Removab will initially be launched in Germany within the next few weeks and will subsequently be introduced in other European countries. With its trifunctional mode of action Removab represents a new generation of antibodies using the body's own immune system to help fight the tumor cells. It is approved for the treatment of malignant ascites in patients with EpCAM positive carcinomas where standard therapy is not available or no longer feasible. The antibody will be administered as four intraperitoneal infusions with ascending doses following a paracentesis.

Malignant ascites is most common in ovarian, pancreatic and gastric cancers with an incidence of 20 to 50 % of all cases. Malignant ascites develops late in the course of the cancer disease and regularly has a strong impact on the patient's quality of life. Removab effectively destroys cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation leading to a significant improvement in the quality of life. 

 

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About the Pivotal Study
The study involved 258 patients with malignant ascites due to carcinomas. Of those, 129 suffered from ovarian cancer while another 129 had non-ovarian cancers.
Patients received paracentesis followed by four intraperitoneal infusions of Removab within 11 days, or paracentesis alone (control group).

The trial met its primary endpoint with high statistical significance. Patients treated with Removab showed a median puncture-free survival (primary endpoint) of 46 days compared with 11 days in the control group (p< 0.0001) (Hazard Ratio: 0.254). Puncture-free survival was defined as the period between the last infusion and the first subsequent necessary paracentesis or death, whichever occurred first. The median puncture-free time – a secondary endpoint which did not include the data from patients who died before the next ascites puncture was due – was 77 days versus 13 days (p< 0.0001).

The most common side effects observed during the trial, such as fever, nausea and vomiting were all due to Removab's postulated mode of action. These side effects were predictable, limited, manageable and mostly fully transient.

Malignant Ascites
Malignant ascites can be caused by different carcinomas. Abdominal spread of cancer cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out on average every one to two weeks and can lead to complications such as infection and fluid or protein deprivation. The trifunctional antibody Removab is known to kill cancer cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation.

The most common carcinomas causing malignant ascites are: ovarian, gastric, colorectal, pancreatic, breast and endometrial.

Epithelial Cell Adhesion Molecule (EpCAM)
EpCAM is a tumor associated antigen expressed on the vast majority of carcinomas (epithelial tumors). EpCAM is expressed on tumor cells in the majority of effusions (ascites) due to carcinomas.

Trifunctional Antibody Removab® (catumaxomab)
Removab with its trifunctional mode of action represents the first antibody of a new generation. The therapeutic objective of Removab is to generate a stronger immune reaction against cancer cells. Removab binds to three different cell types simultaneously: One arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is expressed in many types of carcinomas. In addition, immune effector cells with Fc receptors (such as macrophages, monocytes, dendritic cells and natural killer cells) bind to the Fc region of Removab. This simultaneous binding subsequently results in the co-stimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against cancer cells.

Preclinical data for trifunctional antibodies also suggest a potential long-lasting effect to prevent cancer recurrence. Removab is further developed in various indications (e.g. gastric and ovarian cancer) addressing the underlying cancer.
Catumaxomab is a trifunctional antibody licensed from TRION Pharma GmbH.

Fresenius Biotech, a company of the Fresenius health care group, is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. Fresenius Biotech is a German company with headquarters in Munich. For more information please visit www.fresenius-biotech.com.

Removab® is a registered trade mark by Fresenius Biotech GmbH.

Trion Pharma is a biopharmaceutical company developing trifunctional antibodies in collaboration with Fresenius Biotech. The trifunctional antibodies are produced at TRION's site in Munich, Germany, and are based on a proprietary platform technology for which TRION has secured IP around the world. For more information please visit the company's website at www.trionpharma.com.

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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 Biotech does not undertake any responsibility to update the forward-looking statements in this release.

  • Sales € 3.4 billion, +21 % at actual rates, +15 % in constant currency
  • EBIT € 477 million, +27 % at actual rates, +20 % in constant currency
  • Adjusted net income1 € 110 million, +10 % at actual rates, +6 % in constant currency
  • Strong sales and earnings growth
  • Positive impact of currency translation
  • All business segments fully on track - guidance for 2009 confirmed

 

Group outlook for 2009 confirmed
Based on the Group's strong first quarter financial results Fresenius fully confirms its positive outlook for 2009. Group sales are expected to grow by more than 10 % in constant currency. Organic growth is projected to be in a 6 to 8 % range. Adjusted net income1 is expected to increase by approximately 10 % in constant currency.

Fresenius plans to invest € 700 to 750 million in property, plant and equipment (2008: € 764 million).

Strong sales growth across all business segments
Group sales increased by 15 % in constant currency and by 21 % at actual rates to € 3,373 million (Q1 2008: € 2,798 million). Organic sales growth was 8 %. Acquisitions contributed a further 7 %. Currency translation had a positive impact of 6 %. This is mainly attributable to the average US dollar rate improving 13 % against the euro.

Sales growth in the business segments was as follows:
 

In Europe sales grew by 12 % in constant currency with organic sales growth contributing 8 %. In North America sales grew by 18 % in constant currency. Organic growth was 7 %. The strong increase in constant currency sales is mainly due to the consolidation of APP Pharmaceuticals from September 2008. Acquisitions contributed 11 %. Strong organic growth rates were achieved in the emerging markets, reaching 16 % in Asia-Pacific and 14 % in Latin America. 
 

 

Strong earnings growth
Group EBITDA increased by 21 % in constant currency and by 27 % at actual rates to € 613 million (Q1 2008: € 483 million). Group operating income (EBIT) grew by 20 % in constant currency and by 27 % at actual rates to € 477 million (Q1 2008: € 377 million). The Group's EBIT margin was 14.1 % (Q1 2008: 13.5 %).

Group net interest was € -145 million (Q1 2008: € -84 million). Lower average interest rates on liabilities of Fresenius Medical Care were more than offset by incremental debt relating to the acquisitions of APP Pharmaceuticals and Dabur Pharma and currency translation effects.

The other financial result was € 77 million and includes valuation changes of the fair redemption value of both the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR).

The Group tax rate was 33.4 % (Q1 2008: 35.2 %).

Noncontrolling interest increased to € 111 million (Q1 2008: € 90 million), of which 93 % was attributable to the noncontrolling interest in Fresenius Medical Care.

Adjusted net income1 grew by 6 % in constant currency and by 10 % at actual rates to € 110 million (Q1 2008: € 100 million). Both adjusted earnings per ordinary share and adjusted earnings per preference share increased to € 0.68 (Q1 2008: ordinary share € 0.64, preference share € 0.64). This represents an increase of 3 % for both share classes in constant currency.

Reconciliation to net income according to US GAAP
The Group's US GAAP quarterly financial results as of March 31, 2009 include the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. Those special items are recognized in the financial result of the "Corporate/Other" segment. Adjusted earnings represent the Group's business operations in the reporting period.

The table reconciles adjusted net income to net income according to US GAAP in the first quarter of 2009:

Both the Mandatory Exchangeable Bonds and the Contingent Value Rights are viewed as liabilities and therefore recognized with their fair redemption value. Valuation changes will lead to gains or expenses on a quarterly basis until maturity of the instruments.

Net income2 (including special items) was € 164 million or € 1.02 both per ordinary share and per preference share.

 

Continued investments in growth
Fresenius Group spent € 128 million for property, plant and equipment (Q1 2008: € 154 million). Acquisition spending was € 112 million (Q1 2008: € 216 million).

 

Cash flow development
Operating cash flow of € 182 million was below previous year's € 278 million mainly due to an increase of inventories. Net capital expenditure was € 147 million (Q1 2008: € 161 million). Cash flow before acquisitions and dividends was € 35 million (Q1 2008: € 117 million).

 

Balance sheet
Fresenius Group's total assets increased by 2 % in constant currency and by 5 % at actual rates to € 21,537 million (December 31, 2008: € 20,544 million). Current assets increased by 5 % in constant currency and by 7 % at actual rates to € 5,436 million (December 31, 2008: € 5,078 million). Non-current assets grew by 1 % in constant currency and by 4 % at actual rates to € 16,101 million (December 31, 2008: € 15,466 million).

Total shareholders' equity increased by 3 % in constant currency and by 6 % at actual rates to € 7,372 million (December 31, 2008: € 6,943 million). The equity ratio (including noncontrolling interest) improved to 34.2 % (December 31, 2008: 33.8 %).

Group debt increased by 2 % in constant currency and by 5 % at actual rates to € 9,199 million (December 31, 2008: € 8,787 million). The acquisition financing of APP Pharmaceuticals was successfully completed in January 2009. As of March 31, 2009, the net debt/EBITDA ratio (pro forma the acquisition of APP Pharmaceuticals and excluding special items) was 3.6 (December 31, 2008: 3.6).

 

Number of employees increased
As of March 31, 2009, Fresenius increased the number of its employees by 4 % to 126,849 (December 31, 2008: 122,217).

 

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

On April 22, 2009, the European Commission granted Fresenius Biotech the approval for Removab (catumaxomab) for the treatment of malignant ascites with immediate effect. It is the first drug worldwide with a regulatory label for the treatment of malignant ascites and provides an important new therapy approach. The European Commission's decision will apply to all EU member states. Removab will initially be launched in Germany within the next few weeks and will subsequently be introduced in other European countries.

Fresenius Biotech's EBIT was € -10 million in the first quarter of 2009 (Q1 2008: € -9 million). For 2009, Fresenius Biotech confirms its guidance of an EBIT of € -40 million to € -50 million.

1 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals.

2 Net income attributable to Fresenius SE.


The Business Segments

Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of March 31, 2009, Fresenius Medical Care was treating 187,476 patients in 2,448 dialysis clinics.

 

  • Strong organic sales growth of 8 % achieved
  • Outlook 2009 fully confirmed

Fresenius Medical Care achieved sales growth of 2 % to US$ 2,560 million (Q1 2008: US$ 2,512 million). Organic growth was 8 %. Currency translation effects had a negative impact of 6 %. Sales in dialysis services revenue increased by 4 % to US$ 1,923 million (Q1 2008: US$ 1,844 million). In dialysis products sales were US$ 637 million (Q1 2008: US$ 667 million). In constant currency, dialysis products sales increased by 8 %.

In North America sales increased by 6 % to US$ 1,774 million (Q1 2008: US$ 1,668 million). Dialysis services revenue grew by 5 % to US$ 1,577 million. Average revenue per treatment for the U.S. clinics was at US$ 338 in the first quarter of 2009 compared to US$ 326 for the first quarter of 2008 and 335 US$ for the fourth quarter of 2008. This development was based on an increase in underlying reimbursement rates and stable EPO utilization. Sales outside North America ("International" segment) were US$ 786 million (Q1 2008: US$ 844 million). In constant currency, sales growth was 11 %.

EBIT increased by 2 % to US$ 396 million (Q1 2008: US$ 389 million) resulting in an EBIT margin of 15.5 % (Q1 2008: 15.5 %). The margin development mainly reflects higher personnel expenses, increased pharmaceutical costs and the impact of one less dialysis day in the first quarter of 2009 compared to the first quarter of 2008. These effects were partially offset by increased dialysis treatment rates and sales of the newly licensed iron products. Net income* increased by 7 % to US$ 198 million (Q1 2008: US$ 186 million).

Fresenius Medical Care fully confirms its outlook for 2009: the company expects to achieve revenue of more than US$ 11.1 billion, which is more than 8 % growth in constant currency. Net income* is expected to be between US$ 850 million and US$ 890 million in 2009.

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

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


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

  • Strong sales and EBIT growth
  • Outlook 2009 fully confirmed

Fresenius Kabi increased sales by 32 % to € 722 million (Q1 2008: € 545 million). Organic sales growth was 7 %. Net acquisitions contributed 28 % to sales. Currency translation had a net negative impact of 3 %. This was mainly due to the depreciation of currencies in Great Britain, Brazil and South Africa against the euro, whereas positive translation effects resulted from the strengthening of the Chinese yuan.

In Europe, sales reached € 376 million, driven by 5 % organic growth. In North America, sales increased from € 30 million in the first quarter of 2008 to € 168 million in the first quarter of 2009 due to the acquisition of APP Pharmaceuticals. Organic sales growth was 3 %. In the Asia-Pacific region Fresenius Kabi achieved organic sales growth of 10 % to € 111 million. Sales in Latin America and Africa increased to € 67 million, driven by 20 % organic growth.

EBIT grew by 59 % to € 138 million (Q1 2008: € 87 million). EBIT includes a € 7 million non-cash charge related to the amortization of APP intangible assets. The EBIT margin increased to 19.1 % (Q1 2008: 16.0 %). Net interest increased to € 79 million (Q1 2008: € 17 million) due to the acquisition financing. Net income* was € 38 million (Q1 2008: € 46 million).

Sales at APP Pharmaceuticals were US$ 192 million in the first quarter of 2009. Adjusted EBITDA** was US$ 81 million and EBIT was US$ 61 million.

Fresenius Kabi fully confirms its outlook for 2009: the company targets sales growth in constant currency of 25 to 30 %. Further, Fresenius Kabi forecasts an EBIT margin in the range of 19.5 to 20.5 %. Currency translation effects may impact Fresenius Kabi's margin as APP provides a significant earnings contribution from the US$ area. This guidance is based on the US$/€ exchange rate from the beginning of 2009.

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

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



Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. The HELIOS Kliniken Group owns 62 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats about 600,000 in-patients per year at its clinics and operates a total of more than 18,000 beds. 

 

  • Excellent sales and earnings growth
  • Outlook 2009 fully confirmed

Fresenius Helios increased sales by 13 % to € 577 million (Q1 2008: € 509 million). Net acquisitions contributed 8 % to overall sales growth. Strong organic growth of 5 % on a like-for-like basis was again driven by a significant increase in patient numbers.

EBIT grew by 16 % to € 44 million (Q1 2008: € 38 million) due to the excellent business operations of the established clinics. The EBIT margin was 7.6 % (Q1 2008: 7.5 %). Net income* improved by 33 % to € 20 million (Q1 2008: € 15 million).

At HELIOS' established clinics, sales rose by 5 % on a like-for-like basis to € 536 million. EBIT improved by 16 % to € 44 million. The EBIT margin increased to 8.2 % (Q1 2008: 7.5 %). The acquired clinics (consolidation <1 year) achieved sales of € 41 million and a marginally negative EBIT.

Fresenius Helios fully confirms its outlook for 2009: the company expects to achieve sales of more than € 2.3 billion. EBIT is projected to increase to € 180 to 200 million.

* Net income attributable to HELIOS Kliniken GmbH

 

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

  • Strong order backlog ensures further growth
  • Outlook 2009 fully confirmed

Fresenius Vamed achieved strong sales growth of 57 % to € 116 million (Q1 2008: € 74 million). The clinics in the Czech Republic acquired from Fresenius Helios contributed 8 %. Organic sales growth was 49 %. Sales in the project business rose by 94 % to € 68 million (Q1 2008: € 35 million). Sales in the service business increased by 23 % to € 48 million (Q1 2008: € 39 million).

EBIT was € 4 million, unchanged from previous year. Significant sales growth driven by a strong project business in the first quarter of 2009 diluted the EBIT margin to 3.4 %
(Q1 2008: 5.4 %). Net income* of € 4 million was also at previous year's level.

Fresenius Vamed reported an order intake of € 88 million (Q1 2008: € 125 million).

Order backlog increased by 4 % to € 592 million, close to its all-time high of € 595 million in the first quarter of 2008 (December 31, 2008: € 571 million).

Fresenius Vamed fully confirms the outlook for 2009 and expects to achieve both sales and EBIT growth of 5 to 10 %.

* Net income attributable to VAMED AG


Analyst Conference Call and Audio Webcast
As part of the publication of the results for first quarter of 2009 a conference call will be held on April 30, 2009 at 2.00 p.m. CEDT (8.00 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com see Investor Relations / Presentations. Following the call, a recording will be available.

 

Quarterly financial report
The report for the first quarter 2009 will be published on May 12, 2009 (US GAAP) and on May 15, 2009 (IFRS) on our website www.fresenius.com see Investor Relations / Financial Reports.

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

Fresenius today announced its intention to issue Senior Unsecured Notes through its subsidiary Fresenius Finance B.V., subject to market conditions. The offering is currently anticipated to be €125 million in principal amount. Proceeds of the Notes offering will be used to repay short-term debt of the company.

The Notes are being offered in a private placement and there will be no public offering of the Notes.


About Fresenius SE
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approx. € 12.3 billion. On March 31, 2009 the Fresenius Group had 126,849 employees worldwide.

THIS RELEASE IS FOR INFORMATION PURPOSES ONLY AND MAY NOT BE FURTHER DISTRIBUTED OR PASSED ON TO ANY OTHER PERSON OR PUBLISHED, IN WHOLE OR IN PART, FOR ANY PURPOSE.

This release does not constitute or form part of, and should not be construed as, an offer or invitation to subscribe for, underwrite or otherwise acquire, any securities of Fresenius SE ("Fresenius") or any present or future member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of Fresenius or any member of its group or any commitment whatsoever. In particular, this release is not an offer of securities in the United States of America (including its territories and possessions), and securities of Fresenius SE may not be offered or sold in the United States of America absent registration under the Securities Act of 1933 (which Fresenius SE does not intend to effect) or pursuant to an exemption from registration.

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. This includes the risk that the transaction will not be consummated or on other terms. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

This document is directed at and/or for distribution in the U.K. only to (i) persons who 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 (the "Order") or (ii) high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being together referred to as "relevant persons"). This document is directed only at relevant persons. Other persons should not act or rely on this document or any of its contents.

Members of the public are not eligible to take part in the note issue. This announcement is for information purposes only and is directed only at: (a) persons in member states of the European Economic Area who are qualified investors (as defined in Article 2(1)(e) of EU directive 2003/71/EC (the "Prospectus Directive")); (b) persons in the United Kingdom, who are qualified investors and who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations, etc") of the Order; or (iii) persons to whom it may otherwise be lawfully communicated (all such persons in (a) and (b) together being referred to as "relevant persons"). This announcement 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 does not itself constitute an offer for sale or subscription of the notes.

Fresenius today announced that it has successfully placed a tap to its 2006 Senior Notes by its subsidiary, Fresenius Finance B.V. An aggregate principal amount of € 150 million was issued at a price of 92.0 % and a coupon of 5.5 %, resulting in a yield to maturity of 7.0 %. The Notes will mature in 2016 and are callable by the issuer from 2011.

The Notes have been offered in a private placement to institutional investors only. The transaction was well received and substantially oversubscribed.

With the issuance, Fresenius has taken advantage of the currently favorable market environment. The Company will use the proceeds to repay short-term debt. Accordingly, its debt maturity profile will improve.

The Company expects to close and settle the offering of the Notes on June 8, 2009, subject to customary closing conditions. The new Notes are expected to be listed on the Luxembourg Stock Exchange and will increase trading liquidity under the existing 2006 Notes.

About Fresenius SE
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2008, group sales were approx. € 12.3 billion. On March 31, 2009 the Fresenius Group had 126,849 employees worldwide.

THIS RELEASE IS FOR INFORMATION PURPOSES ONLY AND MAY NOT BE FURTHER DISTRIBUTED OR PASSED ON TO ANY OTHER PERSON OR PUBLISHED, IN WHOLE OR IN PART, FOR ANY PURPOSE.

This release does not constitute or form part of, and should not be construed as, an offer or invitation to subscribe for, underwrite or otherwise acquire, any securities of Fresenius SE ("Fresenius") or any present or future member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of Fresenius or any member of its group or any commitment whatsoever. In particular, this release is not an offer of securities in the United States of America (including its territories and possessions), and securities of Fresenius SE may not be offered or sold in the United States of America absent registration under the Securities Act of 1933 (which Fresenius SE does not intend to effect) or pursuant to an exemption from registration.

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. This includes the risk that the transaction will not be consummated or on other terms. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

This document is directed at and/or for distribution in the U.K. only to (i) persons who 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 (the "Order") or (ii) high net worth entities falling within article 49(2)(a) to (d) of the Order (all such persons being together referred to as "relevant persons"). This document is directed only at relevant persons. Other persons should not act or rely on this document or any of its contents.

Members of the public are not eligible to take part in the note issue. This announcement is for information purposes only and is directed only at: (a) persons in member states of the European Economic Area who are qualified investors (as defined in Article 2(1)(e) of EU directive 2003/71/EC (the "Prospectus Directive")); (b) persons in the United Kingdom, who are qualified investors and who are (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order"); or (ii) persons falling within Article 49(2)(a) to (d) ("high net worth companies, unincorporated associations, etc") of the Order; or (iii) persons to whom it may otherwise be lawfully communicated (all such persons in (a) and (b) together being referred to as "relevant persons"). This announcement 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 does not itself constitute an offer for sale or subscription of the notes.

  • Sales € 6.9 billion, +21 % at actual rates, +15 % in constant currency
  • EBIT € 985 million, +26 % at actual rates, +20 % in constant currency
  • Adjusted net income1 € 240 million, +13 % at actual rates, +10 % in constant currency

 

  • Strongly improved Operating and Free Cash Flow
  • Fresenius Medical Care and Fresenius Kabi confirm guidance for 2009, Fresenius Helios and Fresenius Vamed raise their outlook

 

Group outlook for 2009 confirmed
Based on the Group's strong H1 financial results, Fresenius fully confirms its positive outlook for 2009. Group sales are expected to grow by more than 10 % in constant currency. Organic growth is projected to be in a 6 to 8 % range. Adjusted net income1 is expected to increase by approximately 10 % in constant currency.

Fresenius plans to invest € 700 to 750 million in property, plant and equipment.

1 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. These effects are not cash relevant.

Strong sales growth across all business segments
Group sales increased by 15 % in constant currency and by 21 % at actual rates to € 6,895 million (H1 2008: € 5,710 million). Organic sales growth was 8 %. Acquisitions contributed a further 7 %. Currency translation had a positive impact of 6 %. This is mainly attributable to the average US dollar rate improving 13 % against the euro.

Sales growth in the business segments was as follows:

In Europe sales grew by 11 % in constant currency with organic sales growth contributing 7 %. In North America sales grew by 21 % in constant currency, mainly due to the consolidation of APP Pharmaceuticals from September 2008. Strong organic growth rates were achieved in the emerging markets, reaching 14 % in both Asia-Pacific and Latin America.

 

Continued strong earnings growth
Group EBITDA increased by 21 % in constant currency and by 26 % at actual rates to € 1,260 million (H1 2008: € 998 million). Group operating income (EBIT) grew by 20 % in constant currency and by 26 % at actual rates to € 985 million (H1 2008: € 781 million). The Group's EBIT margin increased to 14.3 % (H1 2008: 13.7 %).

Group net interest was € -294 million (H1 2008: € -167 million). Lower average interest rates on liabilities of Fresenius Medical Care were more than offset by incremental debt relating to the acquisitions of APP Pharmaceuticals and Dabur Pharma and currency translation effects.

The other financial result was € 43 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of € 33 million and the Contingent Value Rights (CVR) of € 10 million. These effects are not cash relevant.

The adjusted Group tax rate1 was 30.5 % (H1 2008: 34.2 %). This decrease was largely driven by the revaluation of a tax claim at Fresenius Medical Care.

Noncontrolling interest increased to € 240 million (H1 2008: € 192 million), of which 94 % was attributable to the noncontrolling interest in Fresenius Medical Care.

Adjusted net income2 grew by 10 % in constant currency and by 13 % at actual rates to € 240 million (H1 2008: € 212 million). Adjusted earnings per ordinary share increased to € 1.49 and adjusted earnings per preference share increased to € 1.50 (H1 2008: ordinary share € 1.36, preference share € 1.37). This represents an increase of 7 % for both share classes in constant currency.

1 Adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals.
2 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. These effects are not cash relevant.



Reconciliation to net income according to US GAAP
The Group's US GAAP financial results as of June 30, 2009 include the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. Those special items are recognized in the financial result of the "Corporate/Other" segment. Adjusted earnings represent the Group's business operations in the reporting period.

The table below reconciles adjusted net income to net income according to US GAAP in H1 and Q2 2009:

Both the Mandatory Exchangeable Bonds and the Contingent Value Rights are viewed as liabilities and therefore recognized with their fair redemption value. Valuation changes will lead to gains or expenses on a quarterly basis until maturity of the instruments.

Net income2 (including special items) was € 274 million or € 1.69 per ordinary share and € 1.70 per preference share.

 

Continued investments in growth
Fresenius Group spent € 283 million for property, plant and equipment (H1 2008: € 332 million). Acquisition spending was € 156 million (H1 2008: € 292 million).

 

Operating cash flow increased by 25 %
Operating cash flow increased by 25 % to € 600 million (H1 2008: € 481 million), driven by strong earnings growth and tight working capital management. Net capital expenditure was € 292 million (H1 2008: € 332 million). Cash flow before acquisitions and dividends more than doubled to € 308 million.

1 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. These effects are not cash relevant.
2 Net income attributable to Fresenius SE.


Balance sheet
Fresenius Group's total assets increased by 2 % to € 20,953 million (December 31, 2008: € 20,544 million), there was no significant currency translation effect. Current assets increased by 6 % to € 5,400 million (December 31, 2008: € 5,078 million). Non-current assets grew by 1 % to € 15,553 million (December 31, 2008: € 15,466 million).

Total shareholders' equity increased by 3 % to € 7,169 million (December 31, 2008: € 6,943 million). The equity ratio (including noncontrolling interest) improved to 34.2 % (December 31, 2008: 33.8 %).
Group debt increased by 1 % to € 8,859 million (December 31, 2008: € 8,787 million).

As of June 30, 2009, the net debt/EBITDA ratio (pro forma the acquisition of APP Pharmaceuticals and excluding special items) improved to 3.4 (December 31, 2008: 3.6).

 

Number of employees increased
As of June 30, 2009, Fresenius increased the number of its employees by 4 % to 127,692 (December 31, 2008: 122,217).

 

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

On April 22, 2009, the European Commission granted Fresenius Biotech the approval for Removab (catumaxomab) for the treatment of malignant ascites. Removab was launched in Germany in May 2009. Market launch is under way in other European countries.

Fresenius Biotech's EBIT was € -22 million in H1 2009 (H1 2008: € -20 million). For 2009, Fresenius Biotech expects its EBIT to reach € -40 million to € -45 million. The previous guidance foresaw an EBIT of € -40 million to € -50 million.


The Business Segments

Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of June 30, 2009, Fresenius Medical Care was treating 190,081 patients in 2,471 dialysis clinics.

  • Continued strong organic sales growth of 8 %
  • Outlook 2009 fully confirmed

Fresenius Medical Care achieved sales growth of 3 % to US$ 5,323 million (H1 2008: US$ 5,177 million). Organic growth was 8 %. Currency translation effects had a negative impact of 6 %.

Dialysis services revenue grew by 6 % to US$ 3,977 million (H1 2008: US$ 3,769 million), an increase of 9 % in constant currency. Sales of dialysis products were US$ 1,346 million (H1 2008: US$ 1,408 million). In constant currency, dialysis products sales increased by 8 %.

In North America sales increased by 8 % to US$ 3,650 million (H1 2008: US$ 3,382 million). Dialysis services revenue grew by 7 % to US$ 3,254 million. Average revenue per treatment for the U.S. clinics was at US$ 344 in Q2 2009 compared to US$ 327 for Q2 2008 and 338 US$ for Q1 2009. This development was based on an increase in commercial payor revenue and slightly increased EPO utilization. Sales outside North America ("International" segment) were US$ 1,673 million (H1 2008: US$ 1,795 million). In constant currency, sales growth was 10 %.

EBIT was US$ 813 million, 1 % below the previous year's period partially due to currency translations effects (H1 2008: US$ 818 million), resulting in an EBIT margin of 15.3 % (H1 2008: 15.8 %). This development was primarily due to higher personnel expenses, increased pharmaceutical costs and the impact of the launch of a generic version of PhosLo® in the U.S. market in October 2008. These effects were partially offset by a strong performance of the dialysis product business, increased commercial payor revenue as well as economies of scale from revenue growth. Net income* increased by 6 % to US$ 419 million (H1 2008: US$ 397 million).

Fresenius Medical Care fully confirms its outlook for 2009: the company expects to achieve revenue of more than US$ 11.1 billion, which is more than 8 % growth in constant currency. Net income* is expected to be between US$ 850 million and US$ 890 million in 2009.

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

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


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

  • Continued strong organic sales growth of 7 % (excl. APP and Dabur)
  • EBIT margin increases to 19.3 %
  • Outlook 2009 confirmed

Fresenius Kabi increased sales by 34 % to € 1,500 million (H1 2008: € 1,121 million). Organic sales growth was 7 % (excl. APP and Dabur as they were consolidated as of September 1, 2008). Net acquisitions contributed 29 % to sales. Currency translation had a net negative impact of 2 %. This was due to the depreciation of currencies e.g. in Great Britain and Brazil against the euro, whereas positive translation effects resulted from the strengthening of the Chinese yuan.

In Europe, sales reached € 772 million, driven by 5 % organic growth. In North America, sales increased to € 347 million (H1 2008: € 63 million) due to the acquisition of APP Pharmaceuticals. In the Asia-Pacific region Fresenius Kabi achieved sales of € 235 million. Organic sales growth was 11 %. Sales in Latin America and Africa increased to € 146 million, driven by 19 % organic growth.

EBIT grew by 60 % to € 290 million (H1 2008: € 181 million). EBIT includes a € 14 million non-cash charge related to the amortization of APP intangible assets. The EBIT margin increased to 19.3 % (H1 2008: 16.1 %). Net interest increased to € 157 million (H1 2008: € 34 million) due to the acquisition financing. Net income* was € 85 million (H1 2008: € 97 million).

Sales at APP Pharmaceuticals increased by 18 % to US$ 408 million in H1 2009. Adjusted EBITDA** increased by 31 % to US$ 171 million. EBIT grew by 51% to US$ 129 million. EBIT includes a US$ 18 million non-cash charge related to the amortization of intangible assets. The EBIT margin improved to 31.7 %.

Operating cash flow of Fresenius Kabi increased by 84 % to € 166 million (H1 2008: € 90 million), driven by tight working capital management. Given only moderate growth in capital expenditures, cash flow before acquisitions and dividends more than doubled to € 110 million (H1 2008: € 44 million).

Fresenius Kabi confirms its outlook for 2009: the company targets sales growth in constant currency of 25 to 30 %. Further, Fresenius Kabi forecasts an EBIT margin in the range of 19.5 to 20.5 %. Currency translation effects may impact Fresenius Kabi's margin as APP Pharmaceuticals provides a significant earnings contribution from the US$ area. This guidance is based on the US$/€ exchange rate from the beginning of 2009.

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

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



Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. The HELIOS Kliniken Group owns 62 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats about 600,000 in-patients per year at its clinics and operates a total of more than 18,000 beds.

  • Continued high organic sales growth of 5 %
  • 130 bps EBIT margin increase at established clinics to 9.3 %
  • Sales outlook 2009 fully confirmed, EBIT guidance raised

Fresenius Helios increased sales by 12 % to € 1,164 million (H1 2008: € 1,040 million). Strong organic growth of 5 % was again driven by a significant increase in patient numbers. Net acquisitions contributed 7 % to overall sales growth.

EBIT grew by 20 % to € 100 million (H1 2008: € 83 million) due to the excellent business operations of the established clinics. The EBIT margin increased to 8.6 % (H1 2008: 8.0 %). Net income* improved by 43 % to € 53 million (H1 2008: € 37 million).

At HELIOS' established clinics, sales rose by 5 % to € 1,081 million. EBIT improved by 22 % to € 100 million. The EBIT margin increased to 9.3 % (H1 2008: 8.0 %). The acquired clinics (consolidation <1 year) achieved sales of € 83 million and a near break-even EBIT.

Fresenius Helios fully confirms its sales outlook and raises its EBIT outlook for 2009: the company expects to achieve sales of more than € 2.3 billion. EBIT is projected to reach € 190 to 200 million. The previous guidance was € 180 to 200 million.

* Net income attributable to HELIOS Kliniken GmbH


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

  • Excellent sales growth of 40 %
  • Major order acquired in German project business
  • Outlook 2009 raised

Fresenius Vamed achieved excellent sales growth of 40 % to € 247 million (H1 2008: € 177 million). Organic sales growth was 34 %. The clinics in the Czech Republic acquired from Fresenius Helios contributed 6 %. Sales in the project business rose by 52 % to € 150 million (H1 2008: € 99 million). Sales in the service business increased by 24 % to € 97 million (H1 2008: € 78 million).

EBIT was € 9 million, unchanged from previous year. Significant sales growth driven by a strong project business in H1 2009 diluted the EBIT margin to 3.6 % (H1 2008: 5.1 %). Net income* of € 8 million was € 1 million below previous year's level.

The excellent development of order intake and order backlog continued: Fresenius Vamed reported an order intake of € 156 million (H1 2008: € 170 million, including the ~€ 80 million order for the Tauern Spa World, Kaprun, Austria). In Q2 2009, Fresenius Vamed increased its order intake by 51 % to € 68 million (Q2 2008: € 45 million). The order backlog of € 577 million remained close to its all-time-high of € 595 million (December 31, 2008: € 571 million).

Fresenius Vamed was awarded a € 50 million order from the city of Cologne for the planning and turnkey construction of an extension to the maximum care hospital Cologne-Merheim. This is the largest project order the company has so far received in Germany. The project is scheduled to start in the third quarter 2009. The construction work will take approximately two years.

Fresenius Vamed raises its outlook for 2009 and expects to grow both sales and EBIT by approximately 10 %. Previously, both sales and EBIT were expected to grow by 5 to 10 %.

* Net income attributable to VAMED AG


Analyst Conference Call and Audio Webcast
As part of the publication of the H1 results 2009 a conference call will be held on August 4, 2009 at 2.00 p.m. CEDT (8.00 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast on our website www.fresenius.com at Investor Relations / Presentations. Following the call, a recording will be available.

 

Quarterly financial report
The H1 2009 report will be published on August 7, 2009 (US GAAP) and on August 14, 2009 (IFRS) on our website www.fresenius.com at Investor Relations / Financial Reports.

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

  • Sales € 10.4 billion, +19 % at actual rates, +15 % in constant currency
  • EBIT € 1.5 billion, +24 % at actual rates, +19 % in constant currency
  • Adjusted net income1 € 368 million, +14 % at actual rates,
    +12 % in constant currency
  • Ongoing sales and earnings growth across all business segments
  • Fresenius Medical Care improves guidance
  • Fresenius Kabi confirms guidance - number of product approvals at APP Pharmaceuticals increased
  • Fresenius Helios raises earnings guidance
  • Fresenius Vamed confirms guidance
  • Excellent cash flow results in significantly reduced leverage

 

Group outlook for 2009 fully confirmed

Based on the Group's strong financial results, Fresenius fully confirms its positive outlook for 2009. Group sales are expected to grow by more than 10 % in constant currency. Organic growth is projected to be in a 6 to 8 % range. Adjusted net income1 is expected to increase by approximately 10 % in constant currency.

Fresenius plans to invest € 700 to 750 million in property, plant and equipment.

1 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. Both are non-cash charges.

Strong sales growth across all business segments continued
Group sales increased by 15 % in constant currency and by 19 % at actual rates to € 10,429 million (Q1-3/2008: € 8,761 million). Organic sales growth was 8 % for the first three quarters and increased to 9 % in the third quarter. Acquisitions contributed a further 7 %. Currency translation had a positive impact of 4 %. This is mainly attributable to the average US dollar rate improving 10 % against the euro in the first three quarters of 2009.

Sales growth in the business segments was as follows:

In Europe sales grew by 11 % in constant currency with organic sales growth contributing 8 %. In North America sales grew by 20 % in constant currency, mainly due to the consolidation of APP Pharmaceuticals from September 2008. Strong organic growth rates were achieved in the emerging markets, reaching 13 % in Asia-Pacific and 12 % in Latin America.

 

Continued strong earnings growth
Group EBITDA increased by 19 % in constant currency and by 24 % at actual rates to € 1,911 million (Q1-3/2008 adjusted: € 1,546 million). Group operating income (EBIT) grew by 19 % in constant currency and by 24 % at actual rates to € 1,496 million (Q1-3/2008 adjusted: € 1,209 million). The Group's EBIT margin increased to 14.3 % (Q1-3/2008 adjusted: 13.8 %).

Group net interest was € -439 million (Q1-3/2008: € -271 million). Lower average interest rates on liabilities of Fresenius Medical Care were more than offset by incremental debt relating to the acquisitions of APP Pharmaceuticals and Dabur Pharma and currency translation effects.

The other financial result was € -30 million and includes valuation changes of the fair redemption value of the Mandatory Exchangeable Bonds (MEB) of € -3 million and the Contingent Value Rights (CVR) of € -27 million. Both are non-cash charges.

The adjusted Group tax rate1 was 30.8 % (Q1-3/2008 adjusted: 34.2 %). This decrease was largely driven by the revaluation of a tax claim at Fresenius Medical Care in Q2 2009.

Noncontrolling interest increased to € 363 million (Q1-3/2008: € 293 million), of which 94 % was attributable to the noncontrolling interest in Fresenius Medical Care.

Adjusted net income2 grew by 12 % in constant currency and by 14 % at actual rates to € 368 million (Q1-3/2008 adjusted: € 324 million). Adjusted earnings per ordinary share increased to € 2.28 and adjusted earnings per preference share increased to € 2.29 (Q1-3/2008 adjusted: ordinary share € 2.06, preference share € 2.07). This represents an increase of 11 % at actual rates and 9 % in constant currency for both share classes.

The Group's US GAAP financial results as of September 30, 2009 and as of September 30, 2008, include the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. Those special items are recognized in the financial result of the "Corporate/Other" segment. Adjusted earnings represent the Group's business operations in the reporting period. In the previous year's period, the Group's US GAAP financial statements include in addition several special items relating to the acquisition of APP Pharmaceuticals. Please see page 14 of the Investor News for the reconciliation to earnings according to US GAAP.

Net income3 (including special items) was € 339 million or € 2.10 per ordinary share and € 2.11 per preference share.

1 Adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals.
2 Net income attributable to Fresenius SE; adjusted for the effects of mark-to-market accounting of the Mandatory Exchangeable Bonds (MEB) and the Contingent Value Rights (CVR) relating to the acquisition of APP Pharmaceuticals. Both are non-cash charges.
3 Net income attributable to Fresenius SE.


 

Continued investments in growth
Fresenius Group spent € 442 million for property, plant and equipment (Q1-3/2008: € 502 million). Acquisition spending was € 186 million (Q1-3/2008: € 3,760 million, mainly due to the acquisition of APP Pharmaceuticals).

 

Strong cash flow achieved
Operating cash flow increased by 52 % to € 1,120 million (Q1-3/2008: € 736 million), driven by strong earnings growth and tight working capital management. Net capital expenditure was € 446 million (Q1-3/2008: € 496 million). Cash flow before acquisitions and dividends nearly tripled to € 674 million (Q1-3/2008: € 240 million).

 

Balance sheet
Fresenius Group's total assets were € 20,632 million (December 31, 2008: € 20,544 million). In constant currency, total assets increased by 3 %. Current assets increased by 6 % to € 5,408 million (December 31, 2008: € 5,078 million). Non-current assets decreased by 2 % to € 15,224 million (December 31, 2008: € 15,466 million).

Total shareholders' equity increased by 4 % to € 7,237 million (December 31, 2008: € 6,943 million). The equity ratio (including noncontrolling interest) improved to 35.1 % (December 31, 2008: 33.8 %).

Group debt decreased by 4 % to € 8,476 million (December 31, 2008: € 8,787 million).

As of September 30, 2009, the net debt/EBITDA ratio was 3.1 and significantly improved from 3.6 at December 31, 2008 (pro forma the acquisition of APP Pharmaceuticals and excluding special items).

 

Number of employees increased
As of September 30, 2009, Fresenius increased the number of its employees by 6 % to 129,218 (December 31, 2008: 122,217).

 

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

On April 22, 2009, the European Commission granted Fresenius Biotech the approval for Removab (catumaxomab) for the treatment of malignant ascites. Removab was launched in Germany in May 2009. Market launch is under way in other European countries. As of September 30, 2009, Fresenius Biotech achieved Removab sales of more than € 1 million.

Fresenius Biotech's EBIT was € -32 million in the first three quarters of 2009 (Q1-3/2008: € -32 million). For 2009, Fresenius Biotech expects its EBIT to reach € -40 million to € -45 million.


The Business Segments

Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of September 30, 2009, Fresenius Medical Care was treating 192,804 patients in 2,509 dialysis clinics.

  • Continued strong organic sales growth of 8 %
  • Q3 EBIT margin improved to 15.6 (Q2 2009: 15.1 %)
  • Improved guidance for 2009

Fresenius Medical Care achieved sales growth of 4 % to US$ 8,212 million (Q1-3/2008: US$ 7,890 million). Organic growth was 8 %. Currency translation effects had a negative impact of 5 %.

Dialysis services revenue grew by 6 % to US$ 6,124 million (Q1-3/2008: US$ 5,753 million), an increase of 9 % in constant currency. Sales of dialysis products were US$ 2,088 million (Q1-3/2008: US$ 2,137 million). In constant currency, dialysis products sales increased by 8 %.

In North America sales increased by 9 % to US$ 5,600 million (Q1-3/2008: US$ 5,153 million). Dialysis services revenue grew by 8 % to US$ 4,994 million. Average revenue per treatment for the U.S. clinics increased to US$ 348 in Q3 2009 compared to US$ 333 for Q3 2008 and 344 US$ for Q2 2009. This development was mainly based on reimbursement increases and increased utilization of pharmaceuticals. Sales outside North America ("International" segment) were US$ 2,612 million (Q1-3/2008: US$ 2,737 million). In constant currency, sales growth was 9 %.

EBIT increased by 2 % to US$ 1,265 million (Q1-3/2008: US$ 1,240 million), resulting in an EBIT margin of 15.4 % (Q1-3/2008: 15.7 %). This development was mainly due to higher personnel expenses, price increases for pharmaceuticals as well as the impact of the launch of a generic version of PhosLo® in the U.S. market. These effects were partially offset by a strong performance of the dialysis product business, increased commercial payor revenue as well as the effect of cost control measures.

Net income* increased by 7 % to US$ 645 million (Q1-3/2008: US$ 603 million).

For the full year of 2009, Fresenius Medical Care now expects to achieve revenue of around US$ 11.2 billion (previously US$ 11.1 billion), an increase of around 8 % in constant currency.

Net income* is now expected to be between US$ 865 million and US$ 890 million in 2009. Previously, the company expected the net income to be in the range of US$ 850 million and US$ 890 million for the full year 2009.

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

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


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

  • Organic sales growth accelerated to 8 %
  • EBIT Margin increased to 19.4 %
  • Outlook 2009 confirmed

Fresenius Kabi increased sales by 31 % to € 2,274 million (Q1-3/2008: € 1,734 million). Organic sales growth was 8 % in the first three quarters and increased to 9 % in the third quarter. Net acquisitions contributed 25 % to sales. Currency translation had a net negative impact of 2 %. This was mainly due to the depreciation of currencies in Great Britain and Brazil against the euro, whereas positive translation effects resulted from the strengthening of the Chinese yuan.

In Europe, sales reached € 1,159 million, driven by 5 % organic growth. In North America, sales increased to € 527 million (Q1-3/2008: € 134 million) due to the acquisition of APP Pharmaceuticals. In the Asia-Pacific region Fresenius Kabi achieved sales of € 361 million. Organic sales growth accelerated to 15 %. Sales in Latin America and Africa increased to € 227 million, driven by 16 % organic growth.

EBIT grew by 52 % to € 441 million (Q1-3/2008: € 290 million). EBIT includes a € 20 million non-cash charge related to the amortization of APP Pharmaceuticals' intangible assets. The EBIT margin increased to 19.4 % (Q1-3/2008: 16.7 %). Net interest grew to € 231 million (Q1-3/2008: € 64 million) due to the acquisition financing. Net income* was € 136 million (Q1-3/2008: € 149 million).

Sales at APP Pharmaceuticals increased by 16 % to US$ 632 million. APP Pharmaceuticals achieved significant sales growth in the product portfolio excluding Heparin in Q3, leading to a sales growth of 4 % in the first three quarters 2009. Adjusted EBITDA** grew by 20 % to US$ 260 million. EBIT was US$ 198 million. EBIT includes a US$ 27 million non-cash charge related to the amortization of intangible assets. The EBIT margin improved to 31.3 %. The number of product approvals from the FDA (Food and Drug Administration) has currently increased to seven, following only one approval in the first half of 2009.

Operating cash flow of Fresenius Kabi more than doubled to € 311 million (Q1-3/2008: € 144 million). This was primarily achieved through a tight working capital management. Given only moderate growth in capital expenditures, cash flow before acquisitions and dividends more than tripled to € 224 million (Q1-3/2008: € 69 million).

Fresenius Kabi confirms its outlook for 2009: the company targets sales growth in constant currency of 25 to 30 %. Further, Fresenius Kabi forecasts an EBIT margin in the range of 19.5 to 20.5 %. Currency translation effects may impact Fresenius Kabi's margin as APP Pharmaceuticals provides a significant earnings contribution from the US$ area. This guidance is based on the US$/€ exchange rate from the beginning of 2009.

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

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



Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. The HELIOS Kliniken Group owns 62 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats about 600,000 in-patients per year at its clinics and operates a total of more than 18,000 beds.

  • Organic sales growth accelerated to 6 %
  • Excellent earnings development at the established clinics
  • Sales outlook 2009 confirmed, EBIT guidance raised

Fresenius Helios increased sales by 13 % to € 1,768 million (Q1-3/2008: € 1,568 million). Strong organic growth of 6 % was again driven by a significant increase in admissions. Net acquisitions contributed 7 % to overall sales growth.

EBIT grew by 20 % to € 152 million (Q1-3/2008: € 127 million) due to the excellent business operations of the established clinics. The EBIT margin increased to 8.6 % (Q1-3/2008: 8.1 %). Net income* improved by 39 % to € 82 million (Q1-3/2008: € 59 million).

At HELIOS' established clinics, sales rose by 6 % to € 1,646 million. EBIT improved by 22 % to € 154 million. The EBIT margin increased to 9.4 % (Q1-3/2008: 8.1 %). The acquired clinics (consolidation <1 year) achieved sales of € 122 million and € -2 million EBIT.

Fresenius Helios confirms its sales outlook for 2009 and expects to achieve sales of more than € 2.3 billion. EBIT is now projected to reach more than € 200 million. The previous guidance was € 190 to 200 million.

* Net income attributable to HELIOS Kliniken GmbH


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


  • Sales increased by 36 %
  • Order backlog at new all-time-high, strong order intake achieved in Q3
  • Outlook 2009 fully confirmed

Fresenius Vamed achieved excellent sales growth of 36 % to € 393 million (Q1-3/2008: € 290 million). Organic sales growth was 29 %. The clinics in the Czech Republic acquired from Fresenius Helios contributed 7 %. Sales in the project business rose by 46 % to € 244 million (Q1-3/2008: € 167 million). Sales in the service business increased by 21 % to € 149 million (Q1-3/2008: € 123 million).

EBIT grew by 7 % to € 15 million (Q1-3/2008: € 14 million). Significant sales growth driven by a strong project business diluted the EBIT margin to 3.8 % (Q1-3/2008: 4.8 %). Net income* of € 13 million was € 1 million below previous year's level due to a decrease in interest income as a result of lower interest rates.

The excellent development of order intake and order backlog continued: Fresenius Vamed increased the order intake by 29 % to € 313 million (Q1-3/2008: € 242 million). In Q3 2009, Fresenius Vamed more than doubled its order intake to € 157 million (Q3 2008: € 72 million). Fresenius Vamed was awarded a >€ 80 million order for the turnkey construction of a general hospital in Gabon. The project is scheduled to start in the fourth quarter of 2009. The construction work will take approximately two years.

The order backlog reached the new all-time-high of € 640 million (December 31, 2008: € 571 million).

Fresenius Vamed fully confirms its outlook for 2009 and expects to grow both sales and EBIT by approximately 10 %.

* Net income attributable to VAMED AG


Analyst Conference
As part of the publication of the results of the first three quarters of 2009 a conference call will be held on November 3, 2009 at 2.00 p.m. CET (8.00 a.m. EST). All investors are cordially invited to follow the conference call in a live broadcast on our website www.fresenius.com at Investor Relations / Presentations. Following the call, a recording will be available.

 

Quarterly financial report
The report on the first three quarters of 2009 and the third quarter 2009 will be published on November 9, 2009 (US GAAP) and on November 13, 2009 (IFRS) on our website www.fresenius.com at Investor Relations / Financial Reports.

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 € 11.4 billion, + 5 % at actual rates, + 10 % in constant currency
  • EBIT € 1.6 billion, + 11 % at actual rates, + 17 % in constant currency
  • Net income € 410 million, + 24 % at actual rates, + 28 % in constant currency
  • All financial targets met or exceeded
  • Double-digit EBIT growth in all business segments
  • Strengthened market position through targeted acquisitions
  • 15th consecutive dividend increase

 

Dividend increase of ~15 % per share proposed
Based on the excellent financial results the Management Board will propose to the Supervisory Board a dividend increase of ~15 % to € 0.66 per ordinary share (2006: € 0.57) and € 0.67 per preference share (2006: € 0.58). The corresponding total dividend distribution amounts to € 103.2 million (2006: € 88.8 million).

 

Positive outlook for 2008: Substantial sales and earnings growth expected
For 2008, Fresenius Group projects further improvements in its financial results: Group sales are expected to grow by 8 to 10 % in constant currency. Net income is expected to increase by 10 to 15 % in constant currency. All business segments are expected to contribute to this growth.

Investments in property, plant and equipment and in intangible assets are planned to increase from € 705 million in 2007 to ~€ 750 million.

 

Strong sales growth across all business segments and regions
Group sales increased by 10 % in constant currency and by 5 % at actual rates to € 11,358 million (2006: € 10,777 million). Organic sales growth was 6 %. Acquisitions contributed a further 6 %. Divestitures reduced sales growth by 2 %. Currency translation had a negative impact of 5 %. This is mainly attributable to the average US dollar rate depreciating 9 % against the Euro.

Sales growth in the business segments was affected as follows:

In Europe sales grew by 7 % in constant currency with organic sales growth contributing 5 %. In North America sales grew by 10 % in constant currency due to the full-year Renal Care Group consolidation and an organic growth rate of 5 %.

Strong growth rates were achieved in the emerging markets with organic growth of 9 % in Asia-Pacific, 10 % in Latin America and 26 % in Africa.

 

Excellent earnings growth and strong margin improvement
Group EBITDA increased by 15 % in constant currency and by 10 % at actual rates to € 2,030 million (2006: € 1,843 million). Group operating income (EBIT) grew by 17 % in constant currency and by 11 % at actual rates to € 1,609 million (2006: € 1,444 million). The Group's EBIT margin improved by 80 basis points to 14.2 % (2006: 13.4 %).

Group net interest was € -368 million (2006: € -395 million, including one-time expenses of € 30 million for the early refinancing of Group debt).

The tax rate was 36.1 % (2006: 39.5 %; adjusted for the tax expense related to the divestiture of US dialysis clinics: 37.2 %).

Minority interest increased to € 383 million (2006: € 305 million), of which 92 % was attributable to the minority interest in Fresenius Medical Care.

Group net income grew strongly by 28 % in constant currency and by 24 % at actual rates to € 410 million (2006: € 330 million, including one-time expenses of € 22 million). Earnings per ordinary share were € 2.64 and earnings per preference share were € 2.65 (2006 adjusted for the February 2007 share split: ordinary share € 2.15, preference share € 2.16). This represents an increase of 23 % for both share classes.

 

Investments in property, plant and equipment at high level
Fresenius Group spent € 705 million for property, plant and equipment and intangible assets (2006: € 600 million). The increase is mainly attributable to the business segments Fresenius Medical Care and Fresenius Helios. Acquisition spending was € 613 million (2006: € 3,714 million). All business segments strengthened their market position through targeted acquisitions.

 

Strong cash flow
Operating cash flow increased by 23 % to € 1,296 million (2006: € 1,052 million). Key driver was the strong increase in earnings. Cash flow margin was 11.4 % (2006: 9.8 %). Cash flow before acquisitions and dividends increased by 31 % to € 630 million (2006: € 481 million). Free cash flow after acquisitions (€ 392 million) and dividends (€ 205 million) was € 33 million (2006: € -2,909 million).

 

Solid balance sheet structure: Leverage ratio improved
Fresenius Group's total assets increased by 8 % in constant currency and by 2 % at actual rates to € 15,324 million (December 31, 2006: € 15,024 million). Current assets increased by 5 % to € 4,291 million (December 31, 2006: € 4,106 million). Non-current assets were € 11,033 million (December 31, 2006: € 10,918 million).

Shareholders' equity including minority interest grew by 6 % to € 6,059 million (December 31, 2006: € 5,728 million). The equity ratio (including minority interest) was 39.5 % (December 31, 2006: 38.1 %).

Group debt decreased by 3 % at actual rates to € 5,699 million (December 31, 2006: € 5,872 million). In constant currency, Group debt increased by 3%. The net debt/EBITDA ratio improved to 2.6, well below the level of 3.0 as of December 31, 2006.

 

Number of employees increased
As of December 31, 2007, Fresenius increased the number of its employees by 9 % to 114,181 (December 31, 2006: 104,872). The increase is mainly attributable to the business segments Fresenius Medical Care and Fresenius Helios.

 

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

Following the successful completion of the phase II/III study with Removab® in the indication malignant ascites, Fresenius Biotech dispatched the marketing authorization application to the European Medicines Agency (EMEA) in December 2007. 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. EMEA started the scientific evaluation of the dossier at the end of January 2008. In additional phase II studies Fresenius Biotech is focusing on the use of Removab® for solid tumors in the indications ovarian cancer and gastric cancer.

For the future marketing of Removab® in the USA and Japan, Fresenius Biotech is in discussions with potential partners.

Phase II studies with the antibody Rexomun® (ertumaxumab) in the indication breast cancer are ongoing.

In 2007, Fresenius Biotech's operating income (EBIT) was € -50 million (2006: € -45 million). For 2008, Fresenius Biotech expects an EBIT of approximately € -50 million.

 

The Business Segments

Fresenius Medical Care

Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of December 31, 2007, Fresenius Medical Care was serving 173,863 patients in 2,238 dialysis clinics.

  • Sales increased by 14 % to US$ 9.7 billion
  • Net income well above guidance
  • Outlook 2008: Sales growth of more than 7 % and net income growth of 12 to 15 % expected

In 2007, Fresenius Medical Care achieved excellent sales growth of 14 % to US$ 9,720 million (2006: US$ 8,499 million). This was mainly driven by organic growth of 6 % and by the full-year consolidation of Renal Care Group. Sales in dialysis care increased by 13 % to US$ 7,213 million (2006: US$ 6,377 million). In dialysis products, sales grew by 18 % to US$ 2,507 million (2006: US$ 2,122 million).

In North America sales increased by 11 % to US$ 6,663 million (2006: US$ 6,025 million). Sales outside North America ("International" segment) grew by 24 % (in constant currency: 15 %) to US$ 3,057 million (2006: US$ 2,474 million). Strong sales growth in constant currency was achieved in Europe (+9 %), Latin America (+14 %), and the Asia-Pacific region (+40 %).

EBIT rose by 20 % to US$ 1,580 million (2006: US$ 1,318 million). The EBIT margin was 16.3 % (2006: 15.5 %). Net income increased by 34 % to US$ 717 million (2006: US$ 537 million, including one-time expenses of US$ 37 million).

In November 2007, Fresenius Medical Care announced the acquisition of Renal Solutions, Inc. (RSI). With the RSI transaction, Fresenius Medical Care is acquiring a key technology for the expansion of home hemodialysis.

For 2008, Fresenius Medical Care expects to achieve revenue of more than US$ 10.4 billion, an increase of more than 7 %. Net income is expected to be between US$ 805 million and US$ 825 million, an increase of 12 % to 15 %.

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.

  • Sales exceed 2 billion euros for the first time
  • Targeted acquisitions strengthen market position
  • Outlook 2008: Strong sales growth and EBIT margin of around 16.5 %

Fresenius Kabi increased sales by 7 % to € 2,030 million (2006: € 1,893 million). The company achieved excellent organic growth of 8 %, at the upper end of the guidance of 6 to 8 %. Acquisitions contributed 1 % to sales. Currency translation effects had a negative impact of 2 %. This was mainly due to the depreciation of currencies in South Africa, China, Mexico and Canada.

Organic sales growth in Europe (excluding Germany) was 5 %. In Germany organic sales growth was 2 %. In the Asia-Pacific region Fresenius Kabi achieved significant organic sales growth of 22 %. Organic sales growth in Latin America was 9 % and in other regions 10 %.

Fresenius Kabi continued its excellent earnings growth in 2007. EBIT grew by 14 % to € 332 million (2006: € 291 million). The EBIT margin improved by 100 basis points to 16.4 % (2006: 15.4 %). Fresenius Kabi reported strong growth in net income of 28 % to € 183 million (2006: € 143 million, including one-time expenses for early debt refinancing of € 11 million).

In the fourth quarter of 2007, Fresenius Kabi announced acquisitions to strengthen its business activities especially in the fields of clinical nutrition and intravenously administered generic drugs (I.V. drugs). Fresenius Kabi acquired from Nestlé S.A. the enteral nutrition businesses in France (Novartis Nutrition) and in Spain (Nestlé España). In addition, Fresenius Kabi acquired the Chilean company Laboratorio Sanderson S.A. and the Italian company Ribbon S.r.L. Aggregate sales of the three acquired businesses was about € 128 million in 2007.

Fresenius Kabi expects to continue its positive financial performance in 2008. The company targets sales growth in constant currency of 12 to 15 %. Organic growth is expected to contribute 7 % to this target. Strong growth is anticipated in particular from the Asia-Pacific and Latin America regions. Further, Fresenius Kabi forecasts an EBIT margin of around 16.5 %. It is anticipated that the recent acquisitions will initially contribute to Fresenius Kabi's EBIT at a margin below par, also due to amortization of intangible assets. Adjusted for the recent acquisitions, Fresenius Kabi's EBIT margin is expected to progress into the range of 16.5 to 17 %.

 

Fresenius ProServe
As from January 1, 2008, the former business segment Fresenius ProServe has been replaced by the two business segments Fresenius Helios and Fresenius Vamed. These two businesses had previously made up the business segment Fresenius ProServe. The financial results of Fresenius Helios and Fresenius Vamed are already presented separately on the following pages for the full-year 2007.

The financial performance at Fresenius ProServe was as follows:

Sales grew by 5 % to € 2,268 million (2006: € 2,155 million). Organic growth was 3 %. EBIT increased by 18 % to € 181 million (2006: € 154 million). The EBIT margin improved to 8.0 % (2006: 7.1 %).

Organic sales growth guidance of 2 - 3 % and EBIT projection of > € 170 million was fully achieved.

The subsidiaries Pharmaplan and Pharmatec were divested and deconsolidated as from January 1, 2007, and June 30, 2007, respectively.

 

Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. The HELIOS Kliniken Group owns 60 hospitals, including five maximum care hospitals in Erfurt, Berlin-Buch, Wuppertal, Schwerin and Krefeld. HELIOS treats about 500,000 inpatients per year at its clinics and has a total of approximately 17,200 beds.

  • Sales and earnings substantially increased
  • Expansion in the German hospital market continued
  • Outlook 2008: Sales of more than 2 billion euros expected

Fresenius Helios increased sales by 10 % to € 1,841 million (2006: € 1,673 million), and achieved very good organic growth of 3 %. Acquisitions contributed 9 %, divestitures reduced sales growth by 2 %.

EBIT increased by 17 % to € 155 million (2006: € 133 million). The EBIT margin improved by 50 basis points to 8.4 %. Fresenius Helios achieved this very good result despite a number of external negative factors: the increase in value-added tax, wage tariff increases, and the 0.5 % budget cut for the stabilization of public health costs all affected earnings. Net income improved by 8 % to € 64 million (2006: € 59 million).

In the fourth quarter of 2007, Fresenius Helios acquired 74.9 % of Krefeld Municipal Hospitals (Krefeld and Hüls). Both hospitals together have approximately 3,300 employees and achieved sales of about € 175 million in 2006. The hospitals are consolidated in the Group's balance sheet as of December 31, 2007.

The outlook for the full year 2008 remains very positive. Fresenius Helios expects to achieve sales of more than € 2,050 million. EBIT is projected to increase to € 160 to 170 million, despite the initially negative contribution of the Krefeld Municipal Hospitals.

 

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

  • Order intake and order backlog at all-time high
  • Acquisition in the service business for hospitals
  • Outlook 2008: Sales and EBIT growth of 5 – 10 % expected

Fresenius Vamed achieved sales growth of 4 % to € 408 million (2006: € 392 million). The project business generated sales of € 259 million (2006: € 249 million), sales in the service business was € 149 million (2006: € 143 million), an increase of 4 % in each segment.

EBIT was € 26 million (2006: € 23 million). The EBIT margin improved to 6.4 % (2006: 5.9 %). Net income increased by 15 % to € 23 million (2006: € 20 million).

Order intake in the project business grew by 17 % to € 395 million (2006: € 337 million). In the fourth quarter of 2007, order intake rose by 70 % compared to the same quarter of the previous year and reached € 173 million. Order backlog as of December 31, 2007, was € 510 million (December 31, 2006: € 387 million).

In February 2008, Fresenius Vamed announced that it had signed an agreement to acquire the hospital planning, consulting and service company HERMED in Germany. Both regionally and strategically, HERMED fits perfectly to the business of VAMED. VAMED concentrates on larger hospitals whereas HERMED focuses on smaller and medium-sized health care facilities. HERMED achieved sales of around € 12 million in 2007.

In 2008, Fresenius Vamed expects to achieve sales growth and an increase in EBIT of 5 to 10 %.

 

Analyst Meeting and Video Webcast
As part of the publication of the results for fiscal year 2007, an analyst meeting will be held at the Fresenius headquarters in Bad Homburg on February 20, 2008 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.com / Investor Relations / Presentations. Following the meeting, a recording of the conference will be available as video-on-demand.

 

Annual report
The annual report 2007 will be available from March 11, 2008 at www.fresenius.com / Investor Relations / Financial reports.

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 Kabi, a business segment of health care group Fresenius, continues its growth strategy in intravenously administered drugs (i.v. drugs). The company today announced the acquisition of 73.3 % of the share capital of the Indian company Dabur Pharma Ltd. for a price of INR 8,782 million (€ 139 million) or INR 76.50 per share in cash. In accordance with Indian regulations, Fresenius Kabi also announced a public offer to acquire up to a further 20 % shareholding for a price of INR 76.50 per share in cash. Fresenius Kabi has entered into an agreement with a third party to secure the participation of 2.4 % of Dabur Pharma's share capital in the public offer.

Dabur Pharma, headquartered in New Delhi, is one of the leading suppliers of generic drugs and active pharmaceutical ingredients (API) to treat cancer. The company holds a substantial number of drug registrations in Asia, Europe and the US. Dabur Pharma is also one of the few manufacturers worldwide to hold international registrations for all steps within the manufacturing process of cytostatic agents. The company operates two production facilities in India and one in Great Britain as well as a research and development center equipped in accordance with European and US standards near New Delhi.

The acquisition significantly expands Fresenus Kabi's i.v. drug portfolio and secures its supply of high quality APIs for cytostatics. With the acquisition of Dabur Pharma, Fresenius Kabi will also broaden its offering of patient-specific oncology therapies. In future, Dabur Pharma will supply Fresenius Kabi's compounding centres in Europe, Asia-Pacific and Latin America where patient-specific formulations of i.v. drugs and parenteral nutrition are being prepared for cancer patients.

Dabur Pharma is listed on the Bombay Stock Exchange and on the National Stock Exchange of India. The company achieved sales of more than € 41 million with generic oncology drugs and APIs in fiscal year 2006/2007 (April 1, 2006 to March 31, 2007) and employs about 960 people. Dabur Pharma pursues an international growth strategy and will benefit from Fresenius Kabi's international sales and marketing organization going forward. In addition, Dabur Pharma will continue to be focused on expanding its research and development.

The acquisition will be entirely debt-financed from funds that have already been procured. The transaction is expected to be accretive to Fresenius Group's Cash EPS in 2 - 3 years.

Closing of the transaction is subject to completion of the public offer process in line with local regulations as well as relevant approvals required under Indian law. This is expected to occur at the beginning of Q3 2008.


Conference Call
A conference call to inform about the acquisition will be held on April 21, 2008 at 4.00 p.m. CEDT. All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com / Investor Relations / Presentations. A replay of the call will be available on our website shortly after the call.

Group Cash EPS: before transaction-related amortization of intangible assets.

About Fresenius Kabi
Fresenius Kabi is the leader in infusion therapy and clinical nutrition in Europe and in its most important countries of Latin America and Asia Pacific. Fresenius Kabi's core product range includes infusion solutions for fluid substitution, blood volume expansion and parenteral nutrition, as well as products for enteral nutrition. Furthermore, the company provides concepts for ambulatory health care and is focused on managing and providing home therapies. With its philosophy "Caring for life" and a comprehensive product portfolio, the company aims at improving the quality of life of patients all over the world. On December 31, 2007 the company had 16,964 employees. In 2007, Fresenius Kabi achieved sales of € 2,030 million and an operating profit of € 332 million. Fresenius Kabi AG is a 100 % subsidiary of the health care group Fresenius SE.

About Dabur
Dabur Pharma Ltd. is committed to the discovery, development and marketing of drugs that fight cancer. Dedicated to its mission of making cancer therapy available to more and more people, it has been expanding ever since inception. The company is the leader in the Indian oncology market and it offers a complete range of products in this segment spanning across injectables, orals, intermediates and APIs and is present in over 40 countries. As of March 31, 2008, the company has 156,669,800 shares outstanding.

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 € 2.8 billion, +1 % at actual rates, +8 % in constant currency
  • EBIT € 377 million, -1 % at actual rates, +7 % in constant currency
  • Net income € 100 million, +8 % at actual rates, +13 % in constant currency

 

  • Excellent growth in constant currency
  • Currency impact based on translational effects
  • Significant progress in generic I.V. drug strategy
  • All business segments fully on track - Guidance for 2008 confirmed

 

Outlook for 2008 confirmed
Based on the Group's strong first quarter financial results Fresenius fully confirms its positive outlook for 2008: Group sales are expected to grow by 8 to 10 % in constant currency. Net income is expected to increase by 10 to 15 % in constant currency. All business segments are expected to contribute to this growth.

 

Sales growth of 8 % in constant currency
Group sales increased by 8 % in constant currency and by 1 % at actual rates to € 2,798 million (Q1 2007: € 2,767 million). Organic sales growth was 5 %. Acquisitions contributed a further 4 %. Divestitures reduced sales growth by 1 %. Currency translation had a negative impact of 7 %. This is mainly attributable to the average US dollar/Euro rate depreciating 14 % from Q1 2007.

Sales growth in the business segments was as follows:

In Europe sales grew by 13 % in constant currency with organic sales growth contributing 6 %. In North America sales grew by 1 % in constant currency. Organic growth was 2 %. Strong growth rates were achieved in the emerging markets with organic growth of 11 % in Asia-Pacific and 16 % in Latin America.

 

Excellent net income growth
Group EBITDA increased by 8 % in constant currency and by 1 % at actual rates to € 483 million (Q1 2007: € 479 million). Group operating income (EBIT) grew by 7 % in constant currency and decreased by 1 % at actual rates to € 377 million (Q1 2007: € 380 million). The Group's EBIT margin was 13.5 % (Q1 2007: 13.7 %).

Group net interest decreased to € -84 million (Q1 2007: € -95 million). This is mainly attributable to lower average interest rates at Fresenius Medical Care and currency translation effects.

The Group tax rate was 35.2 % (Q1 2007: 36.1 %).

Minority interest increased slightly to € 90 million (Q1 2007: € 89 million), of which 92 % was attributable to the minority interest in Fresenius Medical Care.

Group net income grew by 13 % in constant currency and by 8 % at actual rates to € 100 million (Q1 2007: € 93 million). Earnings per ordinary share and per preference share were € 0.64 (Q1 2007: ordinary share € 0.60, preference share € 0.60). This represents an increase of 7 % for both share classes.

 

Substantial investments in growth
Fresenius Group spent € 155 million for property, plant and equipment and intangible assets (Q1 2007: € 140 million). Acquisition spending was € 215 million (Q1 2007: € 155 million).

 

Sustainable cash flow development
Operating cash flow was € 278 million (Q1 2007: € 287 million). The cash flow margin was 9.9 % (Q1 2007: 10.4 %). Given increased net capital expenditure of € 162 million (Q1 2007: € 132 million), cash flow before acquisitions and dividends was € 116 million (Q1 2007: € 155 million). Free cash flow after net acquisitions (€ 158 million) and dividends (€ 5 million) was € -47 million (Q1 2007: € 88 million).

 

Solid balance sheet
Fresenius Group's total assets increased by 3 % in constant currency and decreased by 1 % at actual rates to € 15,149 million (December 31, 2007: € 15,324 million). Current assets increased by 4 % in constant currency and by 1 % at actual rates to € 4,319 million (December 31, 2007: € 4,291 million). Non-current assets were € 10,830 million (December 31, 2007: € 11,033 million).

Shareholders' equity including minority interest increased by 3 % in constant currency and decreased by 1 % at actual rates to € 5,988 million (December 31, 2007: € 6,059 million). The equity ratio (including minority interest) was 39.5 % (December 31, 2007: 39.5 %).

Group debt decreased by 2 % at actual rates to € 5,598 million (December 31, 2007: € 5,699 million). In constant currency, Group debt increased by 2 %. As of March 31, 2008, the net debt/EBITDA ratio was 2.6 (December 31, 2007: 2.6).

 

Number of employees increased
As of March 31, 2008, Fresenius increased the number of its employees by 2 % to 116,203 (December 31, 2007: 114,181). The growth was mainly atttributable to Fresenius Kabi and Fresenius Medical Care.

 

Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.

Studies with the antibodies Removab® and Rexomun® in various indications are ongoing in Europe and the US.

Fresenius Biotech's EBIT was € -9 million (Q1 2007: € -11 million). For 2008, Fresenius Biotech expects an EBIT of approximately € -50 million.


The Business Segments

Fresenius Medical Care

Fresenius Medical Care is the world's leading provider of services and products for patients with chronic kidney failure. As of March 31, 2008, Fresenius Medical Care was treating 177,059 patients in 2,297 dialysis clinics.

  • Strong start into the year - in line with expectations
  • Outlook 2008 fully confirmed

Fresenius Medical Care achieved sales growth of 8 % to US$ 2,512 million (Q1 2007: US$ 2,321 million). Organic growth was 5 %. Currency translation effects had a positive impact of 4 %. Sales in dialysis care increased by 5 % to US$ 1,844 million (Q1 2007: US$ 1,760 million). In dialysis products, sales grew by 19 % to US$ 667 million (Q1 2007: US$ 560 million).

In North America sales increased by 2 % to US$ 1,668 million (Q1 2007: US$ 1,637 million). Dialysis services revenue increased by 1 % (3 % adjusted for the divestiture of the perfusion business in spring 2007) to US$ 1,495 million. Average revenue per treatment in the US was US$ 326 in the first quarter (Q4 2007: US$ 325), based on an increase in underlying reimbursement rates and an increase in EPO utiliziation. Sales outside North America ("International" segment) grew by 23 % (10 % in constant currency) to US$ 844 million (Q1 2007: US$ 684 million). Strong sales growth in constant currency was achieved in Europe (+11 %) and Latin America (+14 %).

EBIT rose by 7 % to US$ 389 million (Q1 2007: US$ 365 million) resulting in an EBIT margin of 15.5 % (Q1 2007: 15.7 %). This reflects the increased expenditures for corporate research and development activitites and the expansion in the International dialysis services business. The EBIT margin in North America increased by 60 basis points to 16.4 %, supported by improved underlying reimbursement rates, dialysis services cost containment and a continued strong performance of renal products and PhosLo. In the International segment, the EBIT margin decreased by 60 basis points to 17.0 % mainly due to the growth in the dialysis care business through an increased number of De Novo clinics and associated start-up costs.

Net income increased by 16 % to US$ 186 million (Q1 2007: US$ 160 million).

For 2008, Fresenius Medical Care fully confirms its outlook and expects to achieve revenue of more than US$ 10.4 billion, an increase of more than 7 %. Net income is expected to be between US$ 805 million and US$ 825 million, an increase of 12 % to 15 %.

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 sales growth of 15 % in constant currency
  • Outlook 2008 fully confirmed

Fresenius Kabi increased sales by 15 % in constant currency and by 13 % at actual rates to € 545 million (Q1 2007: € 483 million). Organic growth was excellent at 8 %. Net acquisitions contributed a further 7 % to sales. Currency translation effects had a negative impact of 2 %. This was mainly due to the depreciation of currencies in Great Britain, South Africa and China.

Organic sales growth in Europe (excluding Germany) was 6 %. In Germany organic sales growth was 1 %. In the Asia-Pacific region Fresenius Kabi again achieved significant organic sales growth of 28 %. Organic sales growth in Latin America was 10 % and in other regions 6 %.

EBIT grew by 13 % to € 87 million (Q1 2007: € 77 million). The EBIT margin was 16.0 % (Q1 2007: 15.9 %). Net income grew by 10 % to € 46 million (Q1 2007: € 42 million).

Fresenius Kabi fully confirms the outlook for 2008: The company targets sales growth in constant currency of 12 to 15 %. Organic growth is expected to contribute around 7 % to this target. Further, Fresenius Kabi forecasts an EBIT margin of around 16.5 %.

On April 20, 2008, Fresenius Kabi announced the acquisition of 73.3 % of the share capital of the Indian company Dabur Pharma Ltd. Dabur is a leading supplier of oncology generics. With this acquisition, Fresenius Kabi strengthens its position in I.V. drugs. Dabur achieved sales of more than € 41 million with generic oncology drugs and APIs in fiscal year 2006/2007 (April 1, 2006 to March 31, 2007).

 

Fresenius Helios
Fresenius Helios is one of the largest private hospital operators in Germany. The HELIOS Kliniken Group owns 60 hospitals, including five maximum care hospitals in Berlin-Buch, Erfurt, Krefeld, Schwerin and Wuppertal. HELIOS treats about 500,000 inpatients per year at its clinics and has a total of approximately 17,400 beds.

  • Positive financial performance of established clinics; Krefeld and Hüls with expected negative earnings contribution
  • Outlook 2008 fully confirmed

Fresenius Helios increased sales by 16 % to € 509 million (Q1 2007: € 439 million). Acquisitions contributed 11 % to overall sales growth. Organic growth was 4 %.

EBIT grew strongly by 19 % to € 38 million (Q1 2007: € 32 million) due to the very good financial performance of the established clinics. The first-time consolidation of HELIOS Klinikum Krefeld and the HELIOS Klinik Hüls had the expected negative impact on earnings. Nevertheless, the EBIT margin increased to 7.5 % (Q1 2007: 7.3 %). Net income improved by 36 % to € 15 million (Q1 2007: € 11 million).

Sales at the established clinics rose by 4 % to € 461 million. EBIT improved by 31 % to € 42 million. The EBIT margin was 9.1 % (Q1 2007: 7.3 %). The acquired clinics (consolidation < 1 year) achieved sales of € 48 million and an EBIT of € -4 million.

Fresenius Helios fully confirms its outlook for 2008: The company expects to achieve sales of more than € 2,050 million. EBIT is projected to increase to € 160 to 170 million, including the negative contribution of the clinics in Krefeld and Hüls.

 

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

  • Sales and earnings performance fully in line with expectations
  • Outlook 2008 fully confirmed

In the first quarter of 2008, Fresenius Vamed achieved sales growth of 1 % to € 74 million (Q1 2007: € 73 million). The project business generated sales of € 35 million (Q1 2007: € 37 million), sales in the service business were € 39 million (Q1 2007: € 36 million).

EBIT was € 4 million (Q1 2007: € 5 million). The EBIT margin was 5.4 % (Q1 2007: 6.8 %). Net income was € 4 million (Q1 2007: € 4 million).

Order intake in the project business grew strongly by 89 % to € 125 million (Q1 2007: € 66 million). This was driven by obtaining the order for the planning and construction of the Tauern Spa World in Kaprun/Austria of about € 80 million. Fresenius Vamed will be also responsible for the operational management of Tauern Spa World following the completion of the project. Order backlog as of March 31, 2008 reached a new all-time high of € 595 million, an increase of 17 % (December 31, 2007: € 510 million).

Fresenius Vamed fully confirms its outlook for 2008 and expects to grow both sales and EBIT by 5 to 10 %.

 

Analyst Conference Call and Audio Webcast
As part of the publication of the results for the first quarter of 2008, a conference call will be held on April 30, 2008 at 2.00 p.m. CEDT (8.00 a.m. EDT). All investors are cordially invited to follow the conference call in a live broadcast over the Internet at www.fresenius.com/Investor Relations/Presentations. Following the call, a recording will be available.

 

Quarterly financial report
The report for the first quarter 2008 will be published on May 8, 2008 (US GAAP) and May 15, 2008 (IFRS) on our website www.fresenius.com/Investor Relations/Financial Reports.

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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