- Sales: € 7.8 billion, + 37 % at actual rates, + 36 % in constant currency
- EBIT: € 1.1 billion, + 51 % at actual rates, + 49 % in constant currency
- Net income: 233 million, + 45 % at actual rates, + 43 % in constant currency
- Fresenius Medical Care with excellent performance
- Fresenius Kabi with new record EBIT margin in the third quarter
- Fresenius ProServe sales and earnings fully on track
- Group EBIT for the first time exceeds one billion Euro mark
Group outlook 2006: Earnings forecast raised
Based on the Company's strong financial results in the third quarter, Fresenius raises its full-year 2006 earnings outlook. Net income is now projected to grow by 40 to 45 % in constant currency. This guidance already includes an amount of approximately € 28 million (after tax) associated with expected one-time expenses as well as expenses related to the stock option accounting change. Previously, the Company had expected net income growth of approximately 40 %. Group sales are expected to increase to more than € 10.7 billion.
Sales growth across all business segments and regions
Group sales increased by 37 % to € 7,843 million (Q1-3 2005: € 5,712 million). Excellent organic growth contributed 9 %. Acquisitions, in particular Renal Care Group and HELIOS Kliniken, added 28 %. Divestitures had a -1 % effect on sales. Currency translation effects contributed 1 % to sales growth.
In North America, sales grew significantly due to the Renal Care Group consolidation and an excellent organic growth rate of 8 %. In Europe, the substantial sales increase was mainly driven by the consolidation of HELIOS Kliniken. Organic growth in Europe was 5 %. Excellent growth rates were achieved in the emerging markets with organic growth of 25 % in Asia-Pacific, 20 % in Latin America and 18 % in Africa.
Sales contribution of the three business segments:
Fresenius ProServe's increased sales contribution is the result of the consolidation of HELIOS Kliniken.
Strong earnings growth
Group EBIT increased by 51 % at actual rates and by 49 % in constant currency to € 1,060 million (Q1-3 2005: € 703 million) exceeding the one billion Euro mark for the first time. EBIT includes a gain of € 32 million from the divestitures of dialysis clinics in the USA. The sale was a condition of the US Federal Trade Commission for the approval of the Renal Care Group acquisition. EBIT also includes a total of € 20 million for one-time expenses, mainly for the integration of Renal Care Group as well as for expenses related to the stock option accounting change.
Group net interest was € -295 million, primarily as a result of the debt financing of the Renal Care Group acquisition (Q1-3 2005: € -146 million). Net interest however also includes one-time expenses of € 30 million associated with the early refinancing of Group debt.
The tax rate was 40.9 % (Q1-3 2005: 39.3 %). It was substantially influenced by the tax expense associated with the divestiture of the dialysis clinics in the USA as the goodwill attributable to the divested clinics is not considered for tax purposes. Excluding this effect the tax rate was 37.8 %.
Minority interest was € 219 million (Q1-3 2005: € 177 million). Thereof, 93 % was attributable to the minority interest in Fresenius Medical Care.
Group net income grew strongly by 45 % at actual rates and by 43 % in constant currency to € 233 million (Q1-3 2005: € 161 million). This includes a total of € 22 million for one-time expenses, primarily for the early refinancing of debt, as well as for expenses related to the stock option accounting change.
Earnings per ordinary share were € 4.56 (Q1-3 2005: € 3.92) while earnings per preference share were € 4.58 (Q1-3 2005: € 3.94). This is an increase of 16 % for both share classes (15 % in constant currency). The average number of shares grew to 50.9 million, mainly due to the share issue in December 2005.
Investments
Fresenius Group spent € 374 million for property, plant and equipment and intangible assets (Q1-3 2005: € 196 million). Acquisition spending increased to € 3,537 million (Q1-3 2005: € 264 million) mainly due to the acquisition of Renal Care Group.
Cash flow
Operating cash flow was € 588 million (Q1-3 2005: € 592 million). The strong earnings improvement was offset by net tax payments and other payments related to the divestiture of dialysis clinics and the RCG acquisition as well as by an US tax payment for the years 2000 and 2001. Cash flow before acquisitions and dividends was € 228 million (Q1-3 2005: € 412 million). The acquisition of Renal Care Group was financed through bank debt.
Solid balance sheet structure
Total assets increased by 31 % to € 15,194 million (December 31, 2005: € 11,594 million). In constant currency total assets grew by 36 %. The substantial increase is mainly related to the consolidation of the Renal Care Group. This acquisition was closed effective March 31, 2006. Current assets increased by 15 % to € 4,076 million (December 31, 2005: € 3,531 million). Non-current assets were € 11,118 million (December 31, 2005: € 8,063 million), an increase of 38 %, primarily due to the goodwill resulting from the Renal Care Group acquisition.
Group debt increased to € 6,136 million (December 31, 2005: € 3,502 million) due to the financing of the Renal Care Group acquisition.
As of September 30, 2006, the net debt/EBITDA ratio further improved to 3.2 (March 31, 2006: 3.5; December 31, 2005: 2.3).
Shareholders' equity including minority interest grew 9 % to € 5,583 million (December 31, 2005: € 5,130 million), driven by the very good earnings development. Given the debt financing of the Renal Care Group acquisition, the equity ratio (including minority interest) decreased to 36.7 % (December 31, 2005: 44.2 %).
Employees
As of September 30, 2006, the Group had 104,179 employees worldwide (December 31, 2005: 91,971). The increase of 12,208 employees is primarily due to the acquisition of the Renal Care Group.
Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer as well as cell therapies for the treatment of the immune system. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.
Fresenius Biotech has successfully continued its clinical study program: A phase II study on breast cancer started in March 2006. A phase II study for the treatment of gastric cancer started in June 2006. A phase II study on ovarian cancer is planned to start in the first half of 2007. The results from the pivotal malignant ascites phase II/III study are expected by the end of this year.
For the full year 2006, Fresenius Biotech expects an EBIT of approximately € -45 million. Previously, an EBIT in the range of € -45 to -50 million was expected. The amount largely relates to expenses for the clinical study program. In the first nine months of 2006 EBIT at Fresenius Biotech was € -30 million.
The Business Segments
Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of products and services for patients with chronic kidney failure. As of September 30, 2006, Fresenius Medical Care was serving 161,433 patients in 2,085 dialysis clinics.
* before one-time expenses, expenses related to the stock option accounting change and the effect of the FTC-related clinic divestitures in the USA; excluding 2005 one-time expenses
- Excellent sales and earnings growth in all regions
- Integration of Renal Care Group fully on track
- Outlook for 2006 upgraded
Fresenius Medical Care achieved strong sales growth of 23 % to US$ 6,147 million (Q1-3 2005: US$ 4,999 million). This was driven by both the excellent organic growth of 10 % and the consolidation of the Renal Care Group. Sales in dialysis care increased by 28 % to US$ 4,628 million (Q1-3 2005: US$ 3,610 million). In dialysis products, Fresenius Medical Care achieved sales of US$ 1,519 million (Q1-3 2005: US$ 1,389 million), an increase of 9 % (10 % in constant currency).
In North America, Fresenius Medical Care increased sales by 29 % to US$ 4,367 million (Q1-3 2005: US$ 3,383 million). Organic growth was excellent with 9 %. Sales outside North America ("International") grew by 10 % (11 % in constant currency) to US$ 1,780 million (Q1-3 2005: US$ 1,616 million).
Net income increased by 13 % to US$ 385 million (Q1-3 2005: US$ 339 million). This result includes one-time expenses of US$ 27 million primarily for the refinancing of Fresenius Medical Care debt and the Renal Care Group integration, for expenses related to the stock option accounting change as well as for the after-tax loss on the divestiture of dialysis clinics in the USA. Excluding the above effects and adjusted by one-time expenses in the previous year, net income was up 20 % to US$ 412 million.
Based on the strong performance in the third quarter of 2006, Fresenius Medical Care upgrades its guidance for the full year 2006. After expecting to report net revenue of about US$ 8.3 billion, Fresenius Medical Care now expects net revenue for 2006 of about US$ 8.4 billion.
Fresenius Medical Care also upgrades its outlook for net income for 2006. After expecting a net income of at least US$ 542 million, the company now expects a net income of at least US$ 557 million, representing an increase of at least 18 % over the corresponding level in 2005.
In order to show the underlying performance of Fresenius Medical Care on a basis comparable with the prior year, the guidance does not take into effect any expected one-time items and the stock option accounting change in the fiscal year 2006. Fresenius Medical Care expects the after tax impact of the one-time items and the stock option accounting change to be about US$ 44 million for the full year 2006.
For further information, please see Fresenius Medical Care's Press Release.
Fresenius Kabi
Fresenius Kabi offers infusion therapies and clinical nutrition for seriously and chronically ill patients in the hospital and out-patient environments. The company is also a leading provider of transfusion technology products.
- Strong sales and earnings growth continues
- Filaxis acquisition strengthens i.v. drug portfolio
- Earnings outlook for 2006 raised
Fresenius Kabi's sales increased by 13 % to € 1,404 million (Q1-3 2005: € 1,239 million). The company achieved strong organic growth of 8 %. Acquisitions, primarily Clinico and Australian Pharmatel, contributed 4 % to sales. Currency translation effects contributed 1 % to growth.
Sales in Europe (excluding Germany) increased by 8 %, in Germany by 4 %. Fresenius Kabi continued its exceptional growth outside Europe and achieved sales growth of 44 % in Asia-Pacific, 31 % in Latin America and 21 % in the other regions. Organic growth in the regions outside Europe was again well into the double digits.
Fresenius Kabi showed an even stronger performance at the EBIT level, with an increase of 25 % to € 213 million (Q1-3 2005: € 170 million). The EBIT margin improved to 15.2 % (Q1-3 2005: 13.7 %). In the third quarter, the EBIT margin reached a new record level of 15.8 %. Net profit rose by 25 % to € 101 million (Q1-3 2005: € 81 million). This already includes one-time expenses of € 11 million for the early redemption of the 2003 Euro Bond.
In September 2006, Fresenius Kabi signed an agreement to acquire 100 % of the shares of Filaxis. This Argentinean company based in Buenos Aires specializes in the development, production and distribution of intravenously administered generic drugs for cancer treatment (cytostatics) and markets its comprehensive product portfolio primarily in Latin America. In 2005 the company achieved sales of approximately € 12 million. The Filaxis acquisition strengthens Fresenius Kabi's portfolio of intravenously administered generic drugs by adding oncology products. Once the respective registration processes are finalized, the Filaxis products will also be marketed outside Latin America through Fresenius Kabi's existing sales and distribution organization. The acquisition still has to be approved by the local antitrust authorities.
Based on its excellent performance in the third quarter, Fresenius Kabi raises its full year 2006 earnings outlook and now expects an EBIT margin in the range of 15.0 to 15.5 %. The company confirms its sales outlook and continues to expect an increase of 11 to 12 % in constant currency.
Fresenius ProServe
Fresenius ProServe is a leading German hospital operator with 56 facilities. Moreover, the company offers engineering and services for hospitals and other health care facilities as well as for the pharmaceutical industry.
- Good operating performance in the hospital operations business
- Strong order intake in the engineering and services business
- Outlook confirmed – Full-year 2006 expected to be at the top end of guidance
Fresenius ProServe's sales grew by 6 % to € 1,526 million (Q1-3 2005 incl. HELIOS Kliniken: € 1,442 million). Organic growth was 3 %. On a comparable basis, EBIT increased by 21 % to € 105 million (Q1-3 2005 incl. HELIOS Kliniken: € 87 million).
Sales in hospital operations (HELIOS Kliniken Group) increased by 5 % to € 1,204 million (Q1-3 2005 incl. HELIOS Kliniken : € 1,152 million). The growth is mainly attributable to the acquisition of HUMAINE Kliniken, which was consolidated as from July 1, 2006. Organic growth was 2 %. EBIT increased to € 94 million, the EBIT margin improved to 7.8 % (Q1-3 2005 incl. HELIOS Kliniken: € 79 million and 6.8 %).
Sales in the engineering and services business (VAMED, Pharmaplan) increased 11 % to € 322 million (Q1-3 2005: € 290 million). EBIT rose to € 14 million
(Q1-3 2005: € 9 million). Order intake and order backlog continued to develop very positively. Order intake increased by 22 % to € 291 million (Q1-3 2005: € 239 million). Order backlog rose 21 % to € 437 million as of September 30, 2006 (December 31, 2005: € 360 million).
Fresenius ProServe confirms its outlook but now expects the full-year 2006 to be at the top end of guidance. Guidance calls for revenues to increase by 1 to 3 % before acquisitions (based on 2005 revenues including HELIOS Kliniken of € 2,009 million) and EBIT to rise to € 140 to 150 million (2005 incl. HELIOS Kliniken: € 125 million).
Video Webcast
As part of the publication of our results for the first nine months of 2006, a press conference will be held at the Fresenius headquarters in Bad Homburg on October 31, 2006 at 10.00 am CET. All journalists are cordially invited to follow the conference in a live broadcast on the Internet. Following the meeting, a recording of the conference will be available as video-on-demand.
Summary Third Quarter 2006:
- Net revenue: $ 2,234 million; + 30%
- Operating income (EBIT): $ 349 million; + 47%
- Net income: $ 139 million; + 20%
Excluding SFAS 123(R) and one-time items
- Operating income (EBIT): $ 358 million; + 47%
- Net income: $ 145 million; + 21%
Fresenius Medical Care AG & Co. KGaA ("the Company"), the world's largest provider of Dialysis Products and Services, today announced the results for the third quarter and nine months of 2006.
Please note, the result of operations of Renal Care Group (RCG) are consolidated from April 1, 2006 onwards.
Third Quarter 2006:
Revenue
Net revenue for the third quarter 2006 compared to the third quarter 2005 increased by 30% (29% at constant currency) to $2,234 million. Total organic revenue growth worldwide was 10%. Dialysis Services revenue grew by 37% to $1,704 million (36% at constant currency) in the third quarter of 2006. Dialysis Product revenue increased by 13% to $530 million (11% at constant currency) in the same period.
North America revenue increased by 38% to $1,613 million. Dialysis Services revenue increased by 42% to $1,472 million. Average revenue per treatment for the U.S. clinics increased by 9% to $324 in the third quarter 2006 as compared to $299 for the same quarter in 2005. Dialysis Product revenue increased by 7% to $141 million led by strong sales of our 2008K hemodialysis machines and single-use dialyzer sales (CarepakTM). Excluding RCG and the related divestitures, the dialysis product revenue increased by 14% compared to last year.
International revenue was $621 million, an increase of 13% (11% at constant currency) as compared to the third quarter of 2005. Dialysis Services revenue reached $232 million, an increase of 10% (9% at constant currency). Dialysis Product revenue increased by 15% to $389 million (12% at constant currency), led by strong machine (both the 4008 and 5008 series) and dialyzer sales.
Earnings
Operating income (EBIT) increased by 47% to $349 million. Operating income for the third quarter 2006 includes $9 million of costs related to the change of accounting principles for stock options (SFAS 123R), and the acquisition of RCG.
Excluding these costs, operating income for the third quarter 2006 increased by 47% to $358 million resulting in an operating margin of 16.0%. For the third quarter 2005 the operating margin was 14.2%.
Compared with the third quarter 2005, the operating margin in North America increased by 200 basis points to 16.3% due to the consolidation of RCG, an increase in the revenue per treatment and strong demand for dialysis products. In the International segment, the operating margin increased by 230 basis points to 18.2%. The high operational performance in the International segment was driven by strong product sales in all regions and positively impacted by improvements in key countries in Europe and Latin America.
Net interest expense for the third quarter 2006 was $100 million compared to $42 million in the same quarter of 2005. This increase is entirely attributable to the debt financing for the RCG acquisition.
Income tax expense was $105 million in the third quarter of 2006 as compared to $79 million in the third quarter 2005, reflecting effective tax rates of 42.3% and 40.3%, respectively. The tax rate in the third quarter has been impacted by a tax audit in Germany. Excluding this impact, the tax rate was at approximately 39%.
Net income for the third quarter 2006 was $139 million, an increase of 20%. Excluding one-time costs and SFAS 123(R), the net income increased on a comparable basis by 21% to $145 million.
Earnings per share (EPS) for the third quarter of 2006 rose by 19% to $1.42 per ordinary share ($0.47 per American Depositary Share (ADS), as compared to $1.19 ($0.40 per ADS) for the third quarter of 2005. The weighted average number of shares outstanding for the third quarter of 2006 was approximately 98.2 million shares, as compared to 96.8 million shares for the third quarter 2005. The increase in shares outstanding results from stock option exercises in 2005 and in the first nine months of 2006.
Cash Flow
In the third quarter of 2006, the Company generated $153 million in cash from operations, compared to $202 million last year. Cash from operations in the third quarter includes an U.S. tax payment of $99 million for the years 2000 and 2001. In addition, $9 million payments related to RCG restructuring and integration were made in the third quarter 2006. Excluding these payments, the underlying cash from operations in the third quarter of 2006 was $261 million, or 11.7% of revenue – at the high end of our target. The strong cash flow generation was supported by increased earnings.
A total of $113 million was spent for capital expenditures, net of disposals. Free Cash Flow before acquisitions was $40 million compared to $137 million in the third quarter of 2005. Excluding the tax payment and the payments related to the RCG acquisition, the underlying Free Cash Flow before acquisitions in the third quarter 2006 was $148 million. A total of $10 million in cash was used for acquisitions.
Nine Months ended September 30, 2006:
Earnings and Revenue
For the nine months ended September 30, 2006, net income was $385 million, up 13% from the same period in 2005. Excluding costs related to the change of accounting principles for stock options (SFAS 123R) and one-time items net income increased by 20% to $412 million.
Net revenue for the nine months 2006 was $6,147 million, up 23% from the same period in 2005. Adjusted for currency, net revenue also rose by 23%. Excluding Renal Care Group and the divested clinics revenue for the nine months 2006 grew by 10%.
Operating income (EBIT) increased by 39% to $964 million. Operating income for the nine months ended September 30, 2006 includes a gain of $18 million as a result of the gain from the clinic divestitures, net of costs mainly related to the RCG restructuring and the change of accounting principles for stock options.
Excluding these items, operating income for the nine months 2006 increased by 35% to $946 million. This performance resulted in an operating margin of 15.4% as compared to 14.1% in the same period in 2005.
Net interest expense for the nine months ended September 30, 2006 was $255 million as a result of the write-off of deferred financing costs related to the 2003 senior credit facility of $15 million and two quarters worth of additional interest expense, both in conjunction with the financing of the RCG acquisition.
Income tax expense was $314 million for the nine months compared to $227 million in the same period in 2005, reflecting effective tax rates of 44.3% and 40.0%, respectively. The tax rate has been impacted by tax payments in the U.S. Excluding these impacts, the tax rate was at 40.3%, increased due to tax audit adjustments in Germany.
For the nine months ended September 30, 2006, earnings per ordinary share rose by 12% to $3.93 ($1.31 per ADS). The weighted average number of shares outstanding during the nine months 2006 was approximately 98.0 million.
Cash Flow
Cash from operations for nine months of 2006 was $465 million as compared to $470 million in the same period of 2005. Cash from operations for nine months of 2006 includes $75 million net tax payments and $24 million other payments related to the divestiture of clinics and the RCG acquisition. Also included is an U.S. tax payment of $99 million for the years 2000 and 2001. Excluding these payments the underlying cash from operations was $663 million for nine months of 2006. The increase compared to prior year was mainly due to a favorable development of accounts receivables and improvements in earnings.
A total of $273 million was used for capital expenditures, net of disposals. Free Cash Flow before acquisitions for the nine months of 2006 was $192 million as compared to $308 million in the same period of 2005. Excluding the tax payments and payments related to the RCG acquisition, the underlying Free Cash Flow before acquisitions for nine months of 2006 was $390 million. A total of $44 million in cash was used for acquisitions other than the RCG acquisition in the nine months ended September 30, 2006.
For a complete overview of the third quarter and nine months of 2006 and a reconciliation on non-GAAP financial measures included in this release to the most comparable GAAP financial measures, please refer to the appendix.
Patients - Clinics - Treatments
As of September 30, 2006, Fresenius Medical Care treated 161,433 patients worldwide, which represents a 24% increase in patients compared to the third quarter of last year. North America provided dialysis treatments for 116,868 patients (up 32%) and the International segment served 44,565 patients (up 7%).
As of September 30, 2006, the Company operated a total of 2,085 clinics worldwide, comprised of 1,542 clinics, an increase of 34% in North America, and 543 clinics, an increase of 6%, in the International segment.
Fresenius Medical Care delivered approximately 17.43 million dialysis treatments worldwide, which represents an increase of 19% year over year. North America accounted for 12.34 million treatments, an increase of 23%, and the International segment delivered 5.10 million treatments, an increase of 10% over last year.
Employees
As of September 30, 2006, Fresenius Medical Care employed 56,154 people (full-time equivalents) worldwide compared to 47,521 at the end of 2005. The increase of 8,633 employees is primarily due to the acquisition of Renal Care Group.
PhosLo Acquisition
On October 12, 2006, the Company announced the acquisition of worldwide phosphate binder business (PhosLo) from Nabi Biopharmaceuticals Inc. PhosLo is a calcium acetate phosphate binder for oral application in end-stage renal disease patients. The Company anticipates closing this transaction in 2006. The total consideration paid in the transaction will be $65 million cash at closing, royalties on a new potential product formulation plus milestone payments. The milestone payments consist of $10 million expected to be paid in 2007 and $10 million to be paid over the next two to three years, contingent upon the achievement of certain performance milestones.
New Sourcing and Supply Agreement with Amgen
On October 19, 2006, the Company announced that its subsidiary, Fresenius Medical Care Holdings Inc. (FMC-NA) has entered into a new sourcing and supply agreement with Amgen USA, Inc. (Amgen) under which Amgen will supply FMC-NA's commercial requirements in the United States and Puerto Rico for erythropoiesis stimulating proteins for dialysis patients. The new sourcing and supply agreement runs from October 1, 2006 to December 31, 2011.
Outlook for 2006 – Upgraded
Based on the strong performance in the third quarter of 2006, the Company upgrades its guidance for the full year 2006.
After expecting to report net revenue of about $8.3 billion, the Company now expects net revenue for 2006 of about $8.4 billion.
The Company also upgrades its outlook for net income for 2006. After expecting a net income of at least $542 million, the Company now expects a net income of at least $557 million, representing an increase of at least 18% over the corresponding level in 2005.
In order to show the underlying performance of the Company on a basis comparable with the prior year, the guidance does not take into effect any expected one-time items and the change of accounting principle for stock options - SFAS 123(R) in the fiscal year 2006. The Company expects the after tax impact of the one-time items and SFAS 123(R) to be about $44 million for the full year 2006.
In addition, the Company confirms its guidance on capital expenditures and acquisition spending to be approximately $550 million in 2006.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "Our third quarter and nine months financial results were excellent and exceeded expectations. We continue to see strong growth in both our renal products and services business segments worldwide. In addition, we have taken the next step in our integrated therapy approach acquiring the phosphate binder business (PhosLo) from Nabi Biopharmaceuticals Inc. This acquisition will allow us to further our patient quality outcome initiatives and expand our renal products and therapy business worldwide. Based on our continued successful integration of RCG and the strong financial performance of our underlying business worldwide, we have raised our revenue and net income guidance for 2006."
Video Webcast
Fresenius Medical Care will hold a press conference at its headquarters in Bad Homburg, Germany, to discuss the results of the third quarter and the first nine months of 2006 on October 31, 2006, at 10:00 am CET. The Company cordially invites journalists to view the live video webcast of the meeting at the Company's website www.fmc-ag.com. A replay will be available shortly after the meeting.
# # #
Fresenius Medical Care 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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS-p).
For more information about Fresenius Medical Care visit the Company's website at www.fmc-ag.com.
Fresenius Medical Care
Statement of Earnings see PDF-file
The ninth Fresenius Inventors' Fair will give 20 hand-picked researchers, developers and inventors the opportunity to present their ideas to a broad audience during the MEDICA medical trade show in Dusseldorf from November 15 to 18, 2006. The top three entries will be selected by the Health Care Group Fresenius for the € 10,000 Inventors' Prize. The winning entries are picked on the first day of the MEDICA trade show by a jury of medical and business specialists. Entrants this year include doctors, scientists, engineers, technicians, business people, students and care personnel. Their inventions cover a wide medical spectrum from communication aids for handicapped people to a test for activities of steroid hormones. Innovations at this year's fair even include new methods for finding vascular access in newborns, new injection pumps and updated walkers.
Professor Jürgen Kempf from the technical college of Regensburg is among the 20 entries selected for the fair. Professor Kempf has installed sensors in a pen to record the movements of the hand. The pen can aid in research on diseases such as Parkinson's, schizophrenia and apnea as well as on drug use or side-effects from anti-psychotic medications or antidepressants. Orthopedic doctor Michael Arnhold from Eisenburg developed two orthopedic surgical instruments that allow easier removal of worn prostheses. The Dusseldorf scientist Dr. Christoph Viktor Suschek will present a process for manufacturing nitrogen monoxide with a high degree of purity more easily, economically and efficiently. Nitrate monoxide is used in the treatment of severe lung failure.
The Fresenius Inventors' Fair offers exhibitors the chance to present their innovations to industry representatives and doctors. Fresenius hopes to help link inventors with companies that will further develop or market their innovations – ground-breaking ideas all too often land in archives rather than lending a hand in the treatment of the ill. Past fairs have proven to be useful platforms for inventors to network with industry companies. MEDICA has had more than 137,000 local and foreign visitors in past years.
The Fresenius Inventors' Fair can be found during MEDICA in Hall 7, Level 1 (stand numbers D50 to E60). The awards ceremony will be held on Wednesday, November 15 at 3:00 p.m. 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.
# # #
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.
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 Medical Care AG & Co. KGaA today announced that it has completed the acquisition of the worldwide phosphate binder business (PhosLo) from Nabi Biopharmaceuticals Inc.
With the acquisition, Fresenius Medical Care further expands its market position in the field of dialysis-related drugs. PhosLo is a calcium acetate phosphate binder for oral application in end-stage renal disease patients.
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Fresenius Medical Care 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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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). Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS-p).
For more information about Fresenius Medical Care visit the website: www.fmc-ag.com.
Fresenius Medical Care AG & Co. KGaA today announced positive results from the PhosLo (calcium acetate) CARE-2 (Calcium Acetate Renagel Evaluation) study. The study demonstrated that when lipid levels are kept constant in both treatment groups, there is no difference in cardiovascular calcification between patients treated with PhosLo and those treated with Renagel (sevelamer hydrochloride). The data refute the hypothesis that the calcium in PhosLo contributes to cardiovascular calcification. The findings were presented by Dr. Wajeh Qunibi, of the University of Texas Health Science Center, San Antonio at the American Society of Nephrology's Renal Week 2006 Conference in San Diego, California.
The CARE-2 study was a randomized, controlled head-to-head comparison between PhosLo and Renagel with the addition of Lipitor (atorvastatin calcium), as appropriate, in both treatment groups to control LDL (Low Density Cholesterol) levels. The study found no statistically significant difference in the progression in cardiovascular calcification (CAC) between the two treatment groups after 12 months of treatment. Patients treated with PhosLo and Renagel achieved comparable reductions in Serum-Phosphorus and Calcium-Phosphorus product and even more importantly K/DOQI target levels were reached significantly faster with PhosLo.
PhosLo, Renagel and Lipitor are registered trademarks.
About PhosLo
PhosLo is administered orally, and when given with food, combines with dietary phosphate to form insoluble calcium phosphate complexes that are eliminated from the body, thereby reducing phosphorus absorption, helping to prevent excess blood phosphorus levels. Patients should have serum calcium levels closely monitored and their dose of PhosLo adjusted or terminated to bring levels to normal. PhosLo is contraindicated in patients with hypercalcemia. No other calcium supplements should be given concurrently with PhosLo. PhosLo is well tolerated and has an excellent safety profile. Nausea, hypercalcemia, and pruritus (itching) have occasionally been reported during PhosLo therapy.
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Fresenius Medical Care 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 1,400,000 individuals worldwide. Through its network of 2,085 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 161,433 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). Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS-p).
For more information about Fresenius Medical Care visit the website: www.fmc-ag.com.
For more information about the CARE-2 study visit the website: www.advancedrenaleducation.com.
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.