Three innovations presented during the Inventors' Fair at this year's Medica trade fair were recognized with the Fresenius Inventors' Prize, taking home a total € 12,000 in prize money. The top prize – and € 5,000 – went to a special pen designed by Regensburg technical college professors Jürgen Kempf, Christian Hook and Georg Scharfenberg as well as Dr. Bernhard Sick and Christian Gruber from Passau University. The innovators equipped a pen with sensors to record the neuromuscular activity of the hand. In second place, Dr. Michael Arnhold from Eisenberg will receive € 3,000 for developing two orthopedic surgical instruments that can remove worn implants with less bone damage. As an indication of the level of this year's participants, third prize was divided between two entries: a nitrogen monoxide machine from University lecturer Dr. Christoph Suschek from the University Hospital Aachen and a cold-light source to illuminate the wrists of newborns developed by Bernd Riedmüller from Aalen, Germany. Both will receive € 2,000 for their innovations.
The refined sensors within the pen that won first place record tilt, position and movements of the pen tip as well as the pressure applied to both the tip and by the fingers gripping the pen. "The movements of the hand are a key guide to neuromuscular activity. The sensor pen provides data that can prove very useful in the diagnosis of diseases such as Parkinson's, schizophrenia or stroke. In addition, the neuromuscular activity can highlight the impact of dosages or side effects from medications, reveal drug use or reflect stressful situations," explained Professor Jürgen Kempf. The sensor pen is already being tested in various clinics and laboratories.
"Only a few implant makers deal with the removal of worn implants," said Dr. Michael Arnhold, who works in the orthopedic ward of the Rudolf Elle Hospital in Eisenberg, Germany. The hospital is also home to the orthopedic professorship of Friedrich Schiller University, Jena, Germany. Current equipment is rarely designed to carefully remove worn implants with minimal damage to bones. This provided the spark for Michael Arnhold's innovations. His universal removal tool for hip- and knee-joint replacements either supports itself or is attached directly to the implants to provide better use of force during the removal. Michael Arnhold has already applied for a patent for the tool.
University lecturer Dr. Christoph Suschek from the University Hospital Aachen developed a machine that could drastically reduce the costs for medical procedures using nitrogen monoxide. Because of its ability to expand vessels even at low dosages, the gas is used during acute lung failure or in newborns with difficulty breathing. According to Dr. Suschek, the normal daily dosage for a child can now cost as much as € 3,500 but the new machine can produce the same amount for less than € 1. "The procedure is simple, efficient and delivers gas with a high level of purity. Most importantly, however, is that it is significantly less expensive than using nitrogen monoxide from bottles. It wouldn't only help large clinics save money but would also make nitrogen monoxide treatment in non-specialist clinics and even physicians offices possible." In his device, the biochemist and molecular biologist irradiates a liquid solution of sodium nitrite with UVA light, which decays the substance, releasing nitrogen monoxide. Unwanted and toxic by-products are removed from the solution using special chemicals.
Bernd Riedmüller from Aalen, Germany uses an intensive cold-light source to illuminate the wrists of premature and newborn babies so that doctors can more easily locate tiny arteries for needle insertion. Doctors need such access, for example, to continuously monitor the blood pressure of newborn and premature babies in intensive care.
A jury including doctors, patent specialists and a representative from the German Medical Technology Association (BVMed) selected the winners of the Inventors' Prize from more than 20 entries presented during the Inventors' Fair. The Fresenius health care group hopes the Inventors' Fair will help inventors and researchers forge contacts with the medical industry so that as many innovations as possible can be brought to market and aid in the care of patients. Participants are provided with a Medica stand by Fresenius at no charge to present their developments to specialists and media representatives from around the world.
The Fresenius Inventor's Fair can be found during MEDICA in Hall 7, Level 1 (stand numbers D50 to E60. MEDICA is open from 10 a.m. to 6:30 p.m. from November 15 to November 17 and from 10 a.m. to 5 p.m. on November 18.
Further information on the Inventors' Fair and MEDICA can be found on the Internet at www.fresenius-erfindermesse.de and www.medica.de.
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Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2006 group sales are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.
Fresenius Biotech today announced that the European Commission has granted Orphan Drug Designation for the removab® (catumaxomab) trifunctional antibody to treat gastric cancer. The Orphan Drug Designation entitles Fresenius to up to 10 years market exclusivity in the EU upon marketing approval.
Results from an ongoing phase II study using catumaxomab in about 50 gastric-cancer patients are expected in the second half of 2007. A previous phase I study in patients with advanced peritoneal carcinomatosis (spread and growth of tumor cells in the abdominal cavity) also included patients with gastric cancer and was completed successfully.
Gastric cancer affects an average of three out of 10,000 people in the EU and accounts for about twelve percent of cancer fatalities around the world, making it the second-leading cause of death caused by cancer. Despite medical advances, gastric cancer patients continue to face a low survival rate. Most patients are first diagnosed at an advanced stage because early symptoms are missing or are very unspecific. In addition, many patients face early relapse after surgical resection of the tumor and subsequent chemotherapy, making new, innovative treatments for gastric cancer a high medical need.
Orphan Drug
The EU grants the Orphan Drug Designation to medicinal products used for rare, life-threatening or chronic diseases that affect no more than five in every 10,000 people in the EU and for which no sufficient effective treatment exists. The European Medicines Agency, the EU pharmaceutical regulatory body, supports businesses that research, develop and market such medicines during the development and regulatory approval process.
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Fresenius Biotech is a company of the Fresenius Group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine.
For more information visit the company's website at www.fresenius-biotech.com.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2006 group sales are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.
At the Extraordinary General Meeting in Frankfurt, Germany, a large majority of Fresenius AG's shareholders approved the Management and Supervisory Boards' proposal to convert the Company's legal form from a German stock corporation (Aktiengesellschaft) into a European Company (Societas Europaea – SE). A share split with capital increase from the Company's funds that will triple the number of shares issued was also approved by a vast majority.
The new legal form reflects the international focus of Fresenius Group's business. Through the conversion, all employees in the European Union and in the signatory states to the European Economic Area may now participate in appointing employee representatives to the Supervisory Board. In addition, Fresenius SE's Supervisory Board will continue to have twelve members. Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG, said: "We are convinced that with the new legal form we can successfully continue our high-quality and efficient corporate governance. The SE particularly facilitates an open and international corporate culture. The conversion of Fresenius AG into a European Company and the share split are two consistent steps in the development of the Company. Combined with our long-term strategy focused on profitable growth, these steps will further strengthen Fresenius."
At the Extraordinary General Meeting, 99.99 percent of the ordinary share capital represented approved the conversion of Fresenius AG into an SE. An SE is a public limited-liability company under European law. The conversion will have no effect on the Company's corporate structure and management organization; the legal and economic identity will be preserved. The conversion becomes effective upon the registration in the commercial register. This is scheduled in the third quarter of 2007 after the completion of the procedure for the involvement of the employees.
99.99 percent of the represented ordinary share capital approved the share split. The subscribed capital of Fresenius AG currently amounts to approximately € 131.7 million. It is divided into 25,725,646 ordinary shares and 25,725,646 preference shares. Through a conversion of capital reserves, the subscribed capital will first be increased to approximately € 154.4 million and then divided into 77,176,938 ordinary shares and 77,176,938 preference shares. The new proportionate amount of the subscribed capital will be 1 € per share. After the share split, every holder of an ordinary share will hold three ordinary shares and every holder of a preference share will hold three preference shares. As a result of the share split, the share price will be reduced arithmetically without affecting the overall value for shareholders. The proposed share split is intended to promote trading activity in Fresenius shares and to increase the shares' attractiveness for a broader group of investors. The share split becomes effective upon the registration in the commercial register, which is expected in the first quarter of 2007.
About 79.95 percent of the ordinary share capital was represented at the Extraordinary General Meeting. Only ordinary shareholders were entitled to vote.
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Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2006 group sales are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.
Fresenius today announced encouraging results from a phase II/III pivotal study on malignant ascites in patients with ovarian cancer using the trifunctional antibody removab® (catumaxomab). The antibody showed a clear advantage over a therapy with puncture alone. The median puncture-free survival period (primary endpoint) in the group of patients treated with removab® was significantly longer compared to the control group and clinically relevant. The median puncture-free survival was 52 days in the removab® group versus 11 days in the control group (p< 0.0001).
Positive results were also achieved with regard to key secondary endpoints. The median time to the first therapeutic puncture was 71 days (control group: 11 days; p< 0.0001). In contrast to the primary endpoint, patients who died before the next puncture were not included in this metric. Also, the EpCAM-positive tumor cell concentration in the ascites fluid decreased significantly in patients treated with removab® (p< 0.0009). At the same time, an increase in CD45-positive leukocytes was seen. Both results indicate a direct anti-tumor effect of the trifunctional antibody.
Moreover, removab® showed a very good safety profile. Side effects were mild to moderate with fever, nausea and vomiting being the most common. Pathologic increases of liver parameters and undesirable changes in white blood cell counts were also mild to moderate, transient and without clinical relevance.
"To date, there are only limited therapy options for ovarian cancer patients with malignant ascites. Our data indicate that removab® could become an important new therapy option for this disease. The positive results of the phase I/II study have been fully confirmed by this pivotal phase II/III trial," said Dr. Thomas Gottwald, President Fresenius Biotech.
The results of this two-arm, randomized, open-label study include treatment data of 129 ovarian cancer patients with ascites. The removab® arm included 85 patients, of which 73 received all four doses of 10, 20, 50 und 150 µg each. The intraperitoneal infusions were administered over a six-hour period in intervals of three to four days.
Data on overall survival in connection with the study are expected in the first half of 2007 due to the longer follow-up period associated with this secondary endpoint. Market launch of removab® is expected in 2008.
The current phase II/III study with the trifunctional antibody removab® included a total of 257 patients. The results of the second group (128 patients) with tumor diseases other than ovarian cancer (e.g. gastric cancer) are expected for the first half of 2007.
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Puncture-free survival period
Period between the last infusion (control group: day of the puncture) and the first subsequent necessary puncture or death, which ever occurs first.
Trifunctional Antibodies
Trifunctional antibodies are developed by Fresenius Biotech in cooperation with TRION Pharma. Trifunctional antibodies are proteins that bring together cancer cells with two different cell types of the immune system: T-cells and accessory cells (e.g., natural killer cells, macrophages). This mode of action of the trifunctional antibody is the basis for an immune response against the tumor.
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Fresenius Biotech is a company of the Fresenius health care group, focused on the development and marketing of biopharmaceuticals in the fields of oncology, immunology and regenerative medicine. Additional information is available on the Internet at www.fresenius-biotech.com.
Fresenius is a global health care group with products and services for dialysis, the hospital and the medical care of patients at home. Group sales for the full year 2006 are expected to increase to more than Euro 10.7 billion. As of 30 September 2006, the Fresenius Group had 104,179 employees worldwide.
Fresenius ProServe today announced that it has signed a definitive agreement to sell its subsidiary Pharmaplan GmbH to NNE A/S (NNE). NNE is a wholly owned subsidiary of Novo Nordisk A/S, Copenhagen, a major pharmaceutical company with 22,000 employees worldwide and annual sales of € 4,531 million in 2005.
Pharmaplan provides consulting, engineering and qualification/validation services for the pharmaceutical and GMP-oriented industry worldwide. In 2005, the company had sales of about € 49 million. Pharmaplan currently has about 320 employees, including 130 in Germany. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its business with hospitals and other healthcare facilities. The company offers the full line of services from the planning and construction of hospitals to technical and operational management in its two core areas of hospital management (HELIOS Kliniken) and hospital engineering and services (VAMED). Fresenius ProServe is now well-positioned to successfully participate in the privatization of the hospital market.
NNE is a leading engineering company focused on the biotech and pharma industries. The company is a full-service provider offering conceptual design, validation and operational support. Pharmaplan and NNE's activities and markets complement each other well. The combination of both businesses offers Pharmaplan and its employees exceptional opportunities for future development.
The transaction requires antitrust approval. The Company anticipates the closing of the transaction in the first quarter of 2007. Pharmatec, a Pharmaplan subsidiary with production sites in Dresden, Germany and Ternitz, Austria will not be included in the transaction and will be divested at a later date. Pharmatec manufactures high quality pure steam, pure water and sterilization equipment for the pharmaceutical industry.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and the ambulatory medical care of patients. In 2006 group sales are expected to increase to more than € 10.7 billion. On September 30, 2006 the Fresenius Group had 104,179 employees worldwide.
This release contains forward-looking statements that are subject to certain risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to various factors, e.g., changes in the business, economic and competitive environment, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
The Fresenius Health Care Group will donate cash and goods worth more than $1.1 million to victims of the tsunami in Southeast Asia.
Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG: "We are deeply moved by the suffering caused by the disaster in Asia. To offer swift and unbureaucratic assistance, we have organized an immediate-aid package that includes cash donations, life-saving medical supplies and construction assistance for medical facilities. Our subsidiaries in the region are in close contact with local aid agencies and will handle some of the donations directly."
Fresenius Medical Care will donate $500,000 and Fresenius Kabi will give € 500,000 for aid work in the affected region. A major part will be used to provide financial support to various aid agencies in India, Indonesia, Sri Lanka and Thailand. Furthermore, Fresenius will donate vital medical supplies to hospitals in the region and life-saving products and services for patients with kidney failure.
Fresenius employees have also voluntarily collected donations in many countries including one fund-raising program in India where colleagues agreed to donate a day's pay to victims in the disaster region.
Fresenius is an internationally operating health care group with products and services for dialysis, the hospital and the ambulatory medical care of patients. For more information about the Fresenius Health Care Group, visit the Company's website at www.fresenius-ag.com.
Fresenius Biotech and the US Company Enzon Pharmaceuticals, Inc. today announced the recruitment of the first North American patient for a phase II study for approval of ATG-Fresenius S. The polyclonal antibody suppresses the immune reaction against transplanted organs to reduce the risk of rejection. It is already marketed in over 60 countries. The entry of the first patient into the clinical study is an important milestone to introduce this successful product in the North American market. The cooperation partner Enzon is responsible for the clinical development and approval in the U.S., Fresenius Biotech will manufacture and deliver ATG-Fresenius S.
Enzon and Fresenius Biotech also announced today that the US Food and Drug Administration (FDA) granted Fast Track Status in the approval process for the use of ATG-Fresenius S in lung transplantation. The Fast Track process provides a particularly close working relationship with the FDA in order to accelerate the development and approval of pharmaceuticals that are appropriate to treat critically ill patients where adequate therapeutic modalities are not available. A phase III study using ATG-Fresenius S in renal transplant patients is currently being prepared.
Fresenius Biotech signed a cooperation contract with Enzon Pharmaceuticals in 2003 for the U.S. approval of ATG-Fresenius S. This product is expected to be introduced to the U.S. market in 2007.
Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. Further information can be found on the Company's website www.enzon.com
Fresenius Biotech GmbH is a subsidiary of the health care company Fresenius. Fresenius Biotech is committed to the development and marketing of biopharmaceutics in the areas of oncology, immunology and regenerative medicine.
Fresenius is an internationally operating health care group with products and services for dialysis, the hospital and the ambulatory medical care of patients. Sales amounted in the first nine months of 2004 to 5.4 billion euros. On September 30, 2004 the Fresenius Group had 69,522 employees worldwide.
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 AG does not undertake any responsibility to update the forward-looking statements in this release.
- Sales: € 7.27 billion, + 8 % constant currency, + 3 % at actual exchange rates
- EBIT: € 845 million, + 15 % constant currency, + 8 % at actual exchange rates
- Net Income: € 168 million, + 55 % constant currency, + 46 % at actual exchange rates
- Strong sales and earnings growth at Fresenius Medical Care
- Excellent business development and significantly improved EBIT margin at Fresenius Kabi
- Fresenius ProServe within expectations
- Strong sales and earnings growth expected for 2005
Dividend increase proposed
2004 was a very successful year for Fresenius. Based on the Group's excellent financial results, the Management Board will propose to the Supervisory Board a 10 % dividend increase to € 1.35 per ordinary share (2003: € 1.23) and € 1.38 per preference share (2003: € 1.26). This will mark the 12th consecutive year of a dividend increase. The total dividend distribution will be € 55.9 million (2003: € 51.0 million).
Positive Group outlook for 2005
For 2005, Fresenius expects a constant currency sales increase of 6 to 9 %. Net income is projected to grow by 15 to 20 % in constant currency. All business segments are expected to contribute to this increase.
Fresenius is planning to invest in growth in 2005: Investments in property, plant and equipment and intangible assets are projected to increase to approximately € 400 - 450 million; acquisition spending is planned to grow to about € 400 million.
Strong organic sales growth
In 2004, Group sales increased 8 % in constant currency. Organic growth was 6 %, while acquisitions contributed 2 % to the increase in sales. Currency translation effects had an impact of -5 %. At actual exchange rates, sales were € 7,271 million, 3 % above last year's figure of € 7,064 million.
In Europe, sales increased 4 % despite cost cutting measures in the health care sector and price pressure in Germany. North America performed strongly with sales growing 9 % in constant currency. Asia-Pacific, Latin America and Africa achieved double-digit constant currency growth rates.
Excellent earnings growth
Fresenius achieved excellent earnings growth rates: EBITDA rose 11 % in constant currency and 5 % at actual exchange rates to € 1,160 million (2003: € 1,106 million). EBIT rose 15 % in constant currency and 8 % at actual exchange rates to € 845 million (2003: € 781 million). The EBIT margin improved from 11.1 % in 2003 to 11.6 % in 2004.
Net interest expense continued to improve to € -209 million, € 40 million below last year's € -249 million due to a lower debt level as well as enhanced terms. Currency translation effects also had a favorable impact of € 11 million.
In 2004, the tax rate decreased to 39.8 %. The tax rate of 41.9 % in 2003 was mainly due to one-time expenses at Fresenius ProServe.
Minority interests rose to € 215 million (2003: € 194 million). Minority shareholders in Fresenius Medical Care account for 95 % of minority interests.
Net income rose 55 % in constant currency and 46 % at actual exchange rates to € 168 million (2003: € 115 million). Operating income growth at Fresenius Medical Care and Fresenius Kabi was the key driver of this increase. In addition, lower one-time expenses at Fresenius ProServe as well as lower Group interest expenses had a positive impact. Excluding the one-time expenses at Fresenius ProServe in 2003 and 2004 Group net income increased 25 % in constant currency and 18 % at actual exchange rates.
Earnings per ordinary share were € 4.08 from € 2.79 in 2003. Earnings per preference share were € 4.11 (2003: € 2.82). This is an increase of 46 %.
Investments on target
In 2004, Fresenius invested € 421 million (2003: € 430 million). Investments for property, plant and equipment and intangible assets decreased to € 308 million (2003: € 339 million) and acquisitions increased to € 113 million (2003: € 91 million).
44 % of the total investments were made both in Europe and North America, 7 % in the Asia-Pacific region and 5 % in Latin America and Africa.
Record cash flow
Operating and free cash flow reached new records in 2004: Operating cash flow rose 10 % to € 851 million (2003: € 776 million), mainly due to Group net income growth and improved working capital management. The operating cash flow margin rose to 11.7 % of sales up from 11.0 % in 2003, an increase of 70 basis points. Free cash flow before acquisitions and dividends increased 24 % to € 565 million (2003: € 454 million). After acquisitions and dividends free cash flow rose 31 % to € 353 million (2003: € 269 million) despite increased spending on acquisitions (€ -90 million, net) and dividends (€ -122 million).
Solid balance sheet
Total assets decreased 2 % to € 8,188 million (December 31, 2003: € 8,347 million). In constant currency, assets grew by 2 %. Current assets were € 2,755 million (December 31, 2003: € 2,744 million). In constant currency, current assets rose 3 %, primarily driven by the induction of Fresenius Medical Care's receivables securitization program.
Group debt decreased € 413 million to € 2,735 million as of December 31, 2004 (€ 2,824 million in constant currency) compared to € 3,148 million as of December 31, 2003. These figures include liabilities related to the receivables securitization program.
The key ratio net debt/EBITDA improved significantly to 2.2 on December 31, 2004, as a consequence of both EBITDA growth and debt reduction on the back of the excellent cash flow development (December 31, 2003: 2.7).
Shareholders' equity including minority interests rose 4 % to € 3,347 million compared to € 3,214 million on December 31, 2003 (constant currency: +9 %). The equity ratio including minority interests improved to 40.9 % (December 31, 2003: 38.5 %).
Number of employees slightly increased
As of December 31, 2004, Fresenius had 68,494 employees worldwide, an increase of 3 % (December 31, 2003: 66,264).
Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer as well as cell therapies for the treatment of the immune system. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to suppress graft rejection following an organ transplantation.
In cancer therapy, final results are available of a phase I study to determine dosage, safety and tolerability of the antibody removab® in peritoneal carcinomatosis as well as from a phase I study for the treatment of breast cancer using the antibody rexomun®. The clinical results of the final reports will be published at the 41st ASCO (American Society of Clinical Oncology) Annual Meeting in May 2005. Based on the encouraging results Fresenius Biotech is planning a phase II study for the treatment of breast cancer and a phase II study for the treatment of gastric cancer.
Preliminary results are available for a phase I/II cell therapy study that investigated the treatment of patients with end-stage HIV infection. The results show that the therapy is well tolerated and safe. The clinical development program is planned to continue in the current year.
In 2004, Fresenius Biotech's EBIT was € -28 million (2003: € -19 million). The EBIT development was within our expectations and is a result of the increased research and development spending. For 2005, Fresenius Biotech‘s EBIT is expected to be in the range of € -35 million to € -40 million, largely due to the expanded clinical study program.
The business segments
Fresenius Medical Care
Fresenius Medical Care is the world's largest provider of products and services for patients with chronic kidney failure. As of December 31, 2004, Fresenius Medical Care treated about 124,400 patients (+4 %) in 1,610 dialysis clinics (+3 %), the number of treatments rose by 5 % to about 18.8 million.
- Strong growth in sales and earnings
- Excellent sales development in dialysis care in North America and in dialysis products and dialysis care in the international segment
- Outlook for 2005: significant growth in sales and earnings
Fresenius Medical Care achieved excellent sales growth in 2004 of 13 % to $ 6,228 million (2003: $ 5.528 million). In constant currency, sales rose 10 %. Organic sales growth was 6 %.
In North America, the company's biggest market, Fresenius Medical Care posted exceptionally good performance as sales rose 9 % to $ 4,216 million (2003: $ 3,855 million). Dialysis care sales grew 11 % to $ 3,795 million. Fresenius Medical Care performed about 12.9 million dialysis treatments in 2004, 4 % more than in the previous year. Sales of dialysis products (including sales to our own dialysis clinics) increased 1 % to $ 793 million.
Sales outside North America (the "International" segment) rose 20 % (constant currency: 11 %) to $ 2,012 million (2003: $ 1,673 million). Sales of dialysis products (including sales to our own dialysis clinics) increased 16 % to $ 1,450 million. Dialysis care sales grew 28 % to $ 706 million. In the international segment, Fresenius Medical Care operates 480 dialysis clinics. The Company performed 5.9 million dialysis treatments (+8 %).
Fresenius Medical Care significantly improved earnings in 2004. EBIT increased 13 % to $ 852 million (2003: $ 757 million), the operating margin was 13.7 %. On a comparable basis (excl. the new accounting regulation FIN 46R) the operating margin would have been 13.8 % (2003: 13.7 %). Net income increased 21 % to $ 402 million.
For the year 2005, Fresenius Medical Care expects currency-adjusted sales growth between 6 and 9 % and net income growth in the low double-digit range.
For further information please see Fresenius Medical Care's Investor News at www.fmc-ag.com
Fresenius Kabi
Fresenius Kabi offers infusion therapies and clinical nutrition for seriously and chronically ill patients in the hospital and out-patient environment. The company is also a leading provider of transfusion technology products.
- Profitability significantly increased; EBIT margin of 11.8 % achieved in 2004
- Good organic growth of 5 %; continued double-digit growth in developing markets
- Outlook for 2005: significant growth in earnings expected
Sales at Fresenius Kabi rose 2 % to € 1,491 million in 2004 (2003: € 1,463 million). The company achieved a good organic sales increase of 5 %. Currency translation reduced sales by 1 %, divestments by 2 %. Sales in Europe were impacted by a 6 % decrease in Germany due to cost cuts and price pressure in the health care sector. Outside of Germany, Fresenius Kabi showed an excellent performance in Europe with organic growth of 6 %. Outstanding sales growth was achieved in the Asia-Pacific and Latin America regions posting organic increases of 22 % and 11 %, respectively.
In 2004, Fresenius Kabi reached new records in earnings. EBIT rose 20 % to € 176 million (2003: € 147 million). Besides the good progress made in international markets, cost optimization and efficiency increases, especially in production, had a positive effect. The EBIT margin was 11.8 %, an increase of 180 basis points over 10.0 % of the previous year.
Fresenius Kabi foresees continued momentum for 2005. Sales are expected to increase by about 10 % in constant currency including the Labesfal acquisition. The Asia-Pacific and Latin America regions are projected to continue their growth pattern. In parallel, Fresenius Kabi expects further optimize its cost base. As a consequence of both developments, the company is confident to post yet another significant earnings growth in 2005. The EBIT margin including the Labesfal acquisition is projected to increase to ≥ 13 %.
Fresenius ProServe
Fresenius ProServe offers services for international health care systems, including hospital management, the planning and construction of hospitals and pharmaceutical and medical-technical production plants.
- Earnings within expectations
- Organic sales growth of 10 % achieved
- Strategic reorientation and clear focus on core activities
- Outlook for 2005: continued improvement in earnings
Fresenius ProServe simplified its organizational structure in 2004 and focused on three core activities: hospital management in Germany (Wittgensteiner Kliniken), hospital engineering and services (VAMED) and engineering and services for the pharmaceutical industry (Pharmaplan). The Company divested its nursing home activities and closed its international hospital management activities. Efforts to improve earnings at Wittgensteiner Kliniken were continued according to plan.
Fresenius ProServe increased sales in 2004 to € 813 million (2003: € 742 million). The increase in sales was solely achieved through organic growth and resulted from the positive development of the hospital engineering and services business.
EBIT at Fresenius ProServe was € 9 million (2003: € -19 million), including one-time expenses of € 8 million before taxes (2003: € 34 million). Excluding one-time expenses, Fresenius ProServe achieved an EBIT of € 17 million (2003: € 15 million).
Order intake at the project businesses of VAMED and Pharmaplan was € 244 million in 2004 (2003: € 278 million). This decrease is mainly due to delayed closing of contracts as well as a continued investment caution in the pharmaceutical industry.
Fresenius ProServe expects continued earnings improvement in 2005. Projected EBIT will be between € 20 million and € 25 million. Organic sales growth is expected to be in the range of 5 to 8 % resulting mainly from the hospital engineering and services business.
Video webcast
As part of the publication of our 2004 results, a press conference will be held on February 24, 2005 at 10 a.m. CET. We cordially invite you to follow the live video broadcast of the conference over the Internet at www.fresenius-ag.com. Following the conference, a recording of the conference will be available as video-on-demand.
Annual report
The 2004 Annual Report will be available at the end of March 2005 on the Internet at www.fresenius-ag.com / Investor Relations / Publications
Fresenius Group in figures
Consolidated statement of income: see pdf file
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG does not undertake any responsibility to update the forward-looking statements in this release.
Fresenius AG today announced that Rainer Hohmann, Member of the Management Board of Fresenius AG, will leave the company by mutual agreement effective March 31, 2005. Rainer Hohmann is responsible for the Fresenius ProServe business segment.
The Supervisory Board of Fresenius AG has unanimously appointed Andreas Gaddum (49) as new member of the Management Board responsible for the Fresenius ProServe business segment. He will join Fresenius on or before August 1, 2005. Until then Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG, will oversee the Fresenius ProServe business segment on an interim basis.
Andreas Gaddum began his career at the Haniel Group where he served in a number of senior executive positions. In 2001, he joined the management of Eurest Deutschland GmbH where he is currently responsible for the segment Sales/New Business.
"We thank Rainer Hohmann for his contributions to the company, especially during the restructuring phase of Fresenius ProServe, and wish him all the best for the future. We very much welcome Andreas Gaddum as a new colleague on the Board. In Andreas Gaddum we have found an experienced manager to take the business to the next level," commented Dr. Ulf M. Schneider, Chairman of the Management Board of Fresenius AG.
Fresenius is an internationally operating health care group with products and services for dialysis, the hospital and the ambulatory medical care of patients. Sales amounted in 2004 to 7.27 billion euros. On December 2004 the Fresenius Group had 68,494 employees worldwide.
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 AG does not undertake any responsibility to update the forward-looking statements in this release.
Bad Homburg, Germany -- April 6, 2005 — Fresenius Medical Care AG ("the Company") (Frankfurt Stock Exchange: FME, FME3) (NYSE: FMS, FMS-p), the world's largest provider of dialysis products and services, today announced that its wholly-owned subsidiary, Fresenius Medical Care Holdings, Inc., received on April 1, 2005 a subpoena from the U.S. Department of Justice, Eastern District of Missouri in St. Louis. The subpoena requires production of a broad range of documents relating to the Company's operations, including documents related to, among other things, clinical quality programs, business development activities, medical director compensation and physician relations, joint ventures and our anemia management program. The subpoena covers the period from December 1, 1996 through the present.
The subpoena was issued in connection with a joint civil and criminal investigation of allegations against the Company. The Company intends to cooperate with the government's investigation. To the knowledge of the Company, the government has not initiated legal proceedings against the Company at this time, and it is not possible to predict whether proceedings might be initiated or when the investigation may be concluded. Counsel for the Company had an initial conversation with the United States Attorney's Office, Eastern District of Missouri, on Tuesday April 5, 2005 to begin discussions related to this investigation. The Company intends to meet with representatives of the government to review the government's priorities and the production of responsive documents.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We understand and respect that the government has the right and responsibility to investigate allegations or concerns. We have commented many times before on our pride in our global team's commitment to quality and compliance. In light of our system of internal controls and the procedures we follow under our corporate compliance program and the Corporate Integrity Agreement, I am confident of our position on these issues and other regulatory compliance matters. We look forward to reviewing these extensive compliance processes which we have adopted."
Fresenius Medical Care AG is the world's largest, integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,300,000 individuals worldwide. Through its network of approximately 1,610 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides Dialysis Treatment to approximately 124,400 patients around the globe. Fresenius Medical Care is also the world's leading provider of Dialysis Products such as hemodialysis machines, dialyzers and related disposable products. For more information about Fresenius Medical Care, visit the Company's website at www.fmc-ag.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care AG's reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care AG does not undertake any responsibility to update the forward-looking statements in this release.