A Phase II study with the trifunctional antibody catumaxomab in the treatment of patients with gastric cancer showed the antibody was well tolerated. The primary endpoint of the study – safety and tolerability of catumaxomab administration after tumor resection – was achieved. With this study, controlled results for perioperative administration of catumaxomab are presented for the first time.
The randomized, open-label study included 55 patients with resectable gastric cancer. Tumors of all patients were removed by surgery. 28 patients were included in the catumaxomab arm and treated intraoperatively with 10µg of catumaxomab. Seven days after surgery, these patients were given 10, 20, 50 and 150µg doses of catumaxomab by intraperitoneal administration in intervals of three days. The 27 patients in the control group received no anti-tumor therapy except tumor resection within the study period.
The pattern of complications from surgery was comparable in both groups, with catumaxomab having no impact. Most of the side effects in the catumaxomab group were mild to moderate and based on the mode of action of the antibody. Side effects were mostly limited to the treatment period and were, if needed, treated symptomatically.
Secondary study endpoints were efficacy parameters, e.g. overall survival. As expected, the study showed no statistically or clinically relevant differences between the catumaxomab arm and the control group 12 months after treatment. Due to this short follow-up period and the low number of patients it was not possible to reach specific conclusions regarding the efficacy of the therapy. Other studies with similar patient populations showed a difference in overall survival just after about two years.
After finalization of the ongoing second study in patients with gastric cancer, including neoadjuvant chemotherapy prior to surgery, the safety and tolerability data of catumaxomab administration during surgery will be evaluated. Additional analyses on efficacy of the therapy are also planned.
Background information:
Gastric Cancer
Gastric cancer is the fifth most common type of cancer in men and the seventh most common type of cancer in women. In 2004, about 11,000 men and about 7,800 women had gastric cancer in Germany. In men the incidence peak is at the age of approx. 70, in women it is above 75. (Source: Robert Koch Institute)
The prognosis of patients depends heavily on the stage of the tumor. While five-year survival rates for patients in stage I are up to 80 %, they decline in advanced stages, with a survival rate of about 20 % for patients in stage IIIb and below 5 % for stage IV.
The only curative treatment option is the partial or complete resection of the stomach (gastrectomy) and the regional lymph nodes. If the general condition of the patient is good, the surgery can be preceded by a neoadjuvant chemotherapy to reduce the size of the tumor, which led to a significant improvement of five-year survival to 36 % in a first Phase III study (MAGIC). If tumor tissue remains after the surgery, an additive chemotherapy is administered which might enable a second successful resection. In case of inoperable tumors or distant metastases, a palliative chemotherapy can be administered to alleviate the symptoms and prolong life.
Second Phase II Gastric Cancer Study GC03
In the second study IP-CAT-GC-03, a single-arm trial, gastrectomy follows chemotherapy (neoadjuvant). The primary endpoint of the study is safety and tolerability of the trifunctional antibody catumaxomab. The secondary endpoints are efficacy parameters such as overall survival and disease-free survival.
Trifunctional Antibodies
Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and target tumor cells specifically. Trifunctional antibodies therefore are very effective in destroying cancer cells and show a therapeutic effect even at very low doses. They are being developed by TRION Pharma GmbH.
Mode of action of trifunctional antibody catumaxomab
The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. Catumaxomab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T-cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of intact trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T-cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Apart from removab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development.
Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2007, group sales were approx. € 11.4 billion. On September 30, 2008 the Fresenius Group had 121,288 employees worldwide.
For more information visit the Company's website at www.fresenius.com.
This release contains forward-looking statements that are subject to various risks and uncertainties. Future results could differ materially from those described in these forward-looking statements due to certain factors, e.g. changes in business, economic and competitive conditions, regulatory reforms, results of clinical trials, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.
Board of Management: Dr. Ulf M. Schneider (President and CEO), Rainer Baule, Dr. Francesco De Meo, Dr. Jürgen Götz, Dr. Ben Lipps, Stephan Sturm, Dr. Ernst Wastler
Supervisory Board: Dr. Gerd Krick (Chairman)
Registered Office: Bad Homburg, Germany/Commercial Register No. HRB 10660
With a market share of approximately 14% Excelsior is the largest dialysis service provider in Taiwan treating over 6,500 hemodialysis patients in 90 clinics. The transaction is expected to add about $84 million to the consolidated revenues and to be accretive to the Company's earnings for 2007. The purchase price for the 51% equity interest in Excelsior will be $38 million. The acquisition will be subject to the approval of the Taiwan government Investment Committee.
At the end of 2005 there were nearly 45,000 End Stage Renal Disease (ESRD) patients in Taiwan. The country has experienced approximately 6% growth in patients in recent years with a prevalence rate (patients per one million population) of over 1,900 – the second-highest worldwide.
After the closing of the acquisition, Fresenius Medical Care's share in the number of treated patients in Taiwan will increase from 4% to approximately 18%. Through the transaction, Fresenius Medical Care will become the leading dialysis provider in the Asia-Pacific region and will provide dialysis services to more than 10,000 patients.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are very pleased to further expand our strong product and services base business in Asia. We now have achieved leadership in products and services in all of our key global regions."
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About Jiate Excelsior Co. Ltd.
Jiate Excelsior Co. Ltd. ("Excelsior") was established in 1998 with the headquarters in Taipei and is wholly owned by Enfield Medical Co. Ltd. Excelsior is the largest dialysis provider in Taiwan treating more than 6,500 patients at the end of 2006 in approximately 90 dialysis centers. The company operates and manages dialysis units in hospitals as well as stand-alone clinics. Excelsior has a market share of approximately 14% in Taiwan.
About Fresenius Medical Care
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 is expanding the dialyzer production capacity at the St. Wendel (Germany) production facility by 40%. A total of € 36 million will be invested including associated investment in additional production capacity for proprietary Helixone fibers. The new production line for FX-Class dialyzers is expected to start operating in spring 2008 and will increase the annual capacity for single-use dialyzers from 25 million to 35 million.
The expansion plan at Fresenius Medical Care's major European dialyzer production facility in St. Wendel (Germany) follows recent significant expansion projects at the Company's facilities in Ogden (Utah, U.S.) and Buzen (Japan). As a result of these two expansion projects, the total annual capacity is expected to increase by about 11 million dialyzers worldwide.
Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "The continued expansion of our global production network is in response to the strong increase in global demand for Fresenius Medical Care's single-use dialyzers and other innovative products to treat patients with chronic kidney disease. Furthermore, the investment at the St. Wendel plant demonstrates our strong commitment to our home country Germany and to our more than 1,500 employees, who have built up tremendous proprietary expertise for cost-effective production of high-quality, innovative and successful dialysis products."
In hemodialysis, the dialyzer acts as an artificial kidney, providing the vital functions of the natural organ: Blood flows through as many as 20,000 nearly hair-fine tubes (capillaries) in a plastic housing. The Helixone capillaries are made from Polysulfone, a special polymer with very good filtering capabilities and excellent biocompatibility. Toxins as well as excess water are filtered from the blood through pores in the capillaries and removed with dialysis fluid (dialysate).
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Helixone and Fresenius Polysulfone are registered trade marks of Fresenius Medical Care.
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 today announced the submission of a supplemental New Drug Application (sNDA) with the U.S. Food & Drug Administration (FDA) to allow the Company's proprietary phosphate binder, PhosLo to be labeled for use by patients diagnosed with Stage 4 chronic kidney disease (CKD). The U.S. National Kidney Foundation divides kidney disease into five stages depending on the glomerular filtration rate (GFR) which ranges from more than 90 ml/min in healthy kidneys (Stage 1) to less than 15 ml/min (Stage 5) where dialysis or a kidney transplant is needed. Persons with CKD Stage 4 have advanced kidney damage with a severe decrease in the GFR to 15-29 ml/min, i.e. the filtration rate is significantly lower compared to average healthy kidneys. It is likely someone with Stage 4 CKD will need dialysis or a kidney transplant in the near future. There are approximately 400,000 patients with Stage 4 CKD in the U.S.
The submission of the sNDA is based on data from the "Effect of Calcium Acetate on Phosphorus Levels in Patients with Advanced Chronic Kidney Disease" (EPIC) study. The study, which was presented at the International Society of Nephrology meeting in Copenhagen, Denmark, October 13, 2006, was a prospective, multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of PhosLo in 110 Stage 4 CKD patients. The study achieved its primary endpoint of superior control of serum phosphorus levels (p=0.0003), the calcium-phosphorus product (p=0.001) and serum parathyroid hormone (PTH) (p=0.001) versus placebo.
Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are pleased with the outcome of the EPIC study, which has resulted in the FDA submission. When the application is granted, PhosLo will provide nephrologists another therapeutic option that will allow them to start treatment of hyperphosphatemia earlier."
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PhosLo is a registered trademark of Fresenius Medical Care.
About Hyperphosphatemia
Hyperphosphatemia is an electrolyte disturbance in which there is an abnormally elevated level of phosphate in the blood. Often, calcium levels are lowered (hypocalcemia) due to precipitation of phosphate with the calcium in tissues. It is associated with secondary hyperparathyroidism and commonly seen in chronic renal failure. High phosphate levels can be avoided with phosphate binders and dietary restriction of phosphate.
About PhosLo
PhosLo is an oral prescription calcium acetate phosphate binder currently indicated for the control of elevated phosphorous levels in patients with end stage renal disease (ESRD). PhosLo is administered orally, and when given with food, it 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.
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 AG today announced that the share split with capital increase from the Company's funds approved by the Extraordinary General Meeting on December 4, 2006, will become effective on February 2, 2007. On the same day, the shares will be traded "ex split" and the shareholders' deposits will be adapted to the new number of shares. Every holder of an ordinary share now holds three ordinary shares and every holder of a preference share holds three preference shares.
The Fresenius shares will continue to trade under ISIN DE0005785604 (ordinary share) and ISIN DE0005785638 (preference share).
The subscribed capital of Fresenius AG now amounts to € 154.4 million, divided into 77,176,938 ordinary shares and 77,176,938 preference shares.
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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, the world's leading renal therapy company, today announced that is has agreed with Amgen Europe (Amgen) to establish a joint research project aimed at further improving treatment outcomes for kidney patients in Europe.
In the scope of the joint research agreement, Fresenius Medical Care and Amgen will facilitate a working group of European scientific experts in the renal field. The working group will analyze practices in the treatment of chronic kidney disease (CKD) and will publish their findings for improved therapeutic options.
The working group will be led by renowned independent scientists in the field of nephrology, who will lead the analysis process. Both Amgen and Fresenius Medical Care will engage renowned consultants in the field of nephrology who will help lead the analysis process and develop additional research questions.
The focus of the first research efforts will be on anemia and bone mineral disease affecting patients with kidney failure.
Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are pleased to partner with Amgen in this European initiative. This agreement is a pure research project designed to pool both companies' expertise in the field and analyze data available. This is yet another step in our long-term growth strategy to further enhance our renal drug initiative. Our objective is to assist further improvements in patient medical outcomes with our customers and our own network of clinics."
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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.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
For more information about Amgen visit the Company's website at www.amgen.com.
Fresenius Medical Care, the world's leading renal therapy company, today announced that it has entered into a new agreement with Amgen Europe (Amgen) for Aranesp (darbepoetin alfa).
Under the agreement, Fresenius Medical Care will devote efforts to assist Amgen in disseminating scientific information regarding the treatment of anemia to nephrologists and other dialysis experts. Amgen and its representatives are and will remain solely responsible for the product. The new agreement runs for three years.
Patients with chronic kidney disease on dialysis and not on dialysis often suffer from complications such as anaemia, which occurs when failing kidneys no longer produce sufficient erythropoietin, a hormone that stimulates the production of oxygen-carrying red blood cells. Aranesp is a novel recombinant erythropoiesis stimulating protein (ESP) that stimulates erythropoiesis to produce red blood cells. Aranesp has a proven tolerability and proven efficacy, across all stages of chronic kidney disease.
Dr. Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "We are pleased to partner with Amgen on an expanded scale to further improve medical outcomes for dialysis patients in Europe. Amgen and Fresenius Medical Care are well known for their commitment to developing and establishing new therapies for the benefit of patients with endstage renal disease. Furthermore, this agreement clearly advances our renal drug initiatives and emphasizes the position of both companies as leaders in nephrology innovation."
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Aranesp is a trademark of Amgen Inc.
Aranesp Summary of Product Characteristics. European Medicines Agency.
www.emea.eu.int/humandocs/Humans/EPAR/aranesp/aranesp.htm (Accessed 28th November 2006)
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.
About Amgen
Amgen discovers, develops and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a broad and deep pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives.
For more information about Amgen visit the Company's website at www.amgen.com.
Summary Full Year 2006:
The Company exceeded its financial targets, achieved record earnings and proposes its 10th consecutive annual dividend increase.
Net revenue : $ 8,499 million, + 26%
Operating income (EBIT): $ 1,318 million, + 40%
Net income: $ 537 million, + 18%
Excluding SFAS 123(R) and one-time items
Operating income (EBIT): $ 1,329 million, + 38%
Net income: $ 584 million, + 24%
Dividend proposal
Ordinary share: € 1.41, + 15%
Preference share: € 1.47, + 14%
Fresenius Medical Care AG & Co. KGaA ("the Company"), the world's largest provider of Dialysis Products and Services, today announced its results for the fourth quarter and full year of 2006.
Please note, the result of operations of Renal Care Group (RCG) are consolidated from April 1, 2006 onward.
Fourth Quarter 2006:
Revenue
Net revenue for the fourth quarter 2006 compared to the fourth quarter 2005 increased by 33% (31% at constant currency) to $2,352 million. Organic revenue growth worldwide was 11%. Dialysis Services revenue grew by 39% to $1,749 million (38% at constant currency) in the fourth quarter of 2006. Dialysis Product revenue increased by 17% to $603 million (12% at constant currency) in the same period.
North America revenue increased by 39% to $1,658 million. Dialysis Services revenue increased by 44% to $1,505 million. Average revenue per treatment for the U.S. clinics increased by 9% to $328 in the fourth quarter 2006 compared to $302 for the same quarter in 2005. Dialysis Product revenue increased by 5% to $153 million led by strong sales of our 2008K hemodialysis machines. Excluding the effects of the RCG acquisition and related divestitures, the Dialysis Product revenue increased by 13% compared to last year.
International revenue was $694 million, an increase of 20% (14% at constant currency) compared to the fourth quarter of 2005. Dialysis Services revenue reached $244 million, an increase of 17% (13% at constant currency). Dialysis Product revenue increased by 22% to $450 million (15% at constant currency), led by strong sales of machines (both the 4008 and 5008 series), dialyzers and peritoneal dialysis products.
Earnings
Operating income (EBIT) increased by 45% to $354 million. Operating income for the fourth quarter 2006 includes $29 million of costs related to the change of accounting principles for stock options (SFAS 123R), restructuring costs and in-process R&D.
Excluding these costs, operating income for the fourth quarter 2006 increased by 48% to $383 million resulting in an operating margin of 16.3%. For the fourth quarter 2005 the operating margin was 14.6%.
Compared with the fourth quarter 2005, the operating margin excluding one-time items in North America increased by 260 basis points to 17.1% 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 from an already high level by 30 basis points to 17.7%. The continued strong operational performance in the International segment was driven by increased product sales in all regions and positively impacted by production efficiencies and reimbursement increases in key countries in Europe and Latin America.
Net interest expense for the fourth quarter 2006 was $96 million compared to $46 million in the same quarter of 2005. This increase is entirely attributable to the debt financing for the RCG acquisition.
Income tax expense was $99 million for the fourth quarter of 2006 compared to $82 million in the fourth quarter of 2005, reflecting effective tax rates of 38.5% and 41.3%, respectively.
Net income for the fourth quarter 2006 was $152 million, an increase of 32%. Excluding one-time costs and SFAS 123(R), the net income increased on a comparable basis by 35% to $172 million.
Earnings per share (EPS) for the fourth quarter of 2006 rose by 31% to $1.55 per ordinary share ($0.52 per American Depositary Share (ADS)) compared to $1.18 ($0.39 per ADS) for the fourth quarter of 2005. The weighted average number of shares outstanding for the fourth quarter of 2006 was approximately 98.3 million shares compared to 97.6 million shares for the fourth quarter of 2005. The increase in shares outstanding results from stock option exercises in 2006.
Cash Flow
In the fourth quarter of 2006, the Company generated $443 million in cash from operations, representing 19% of revenue – clearly above our target. The strong cash flow generation was supported by increased earnings.
A total of $177 million was spent for capital expenditures, net of disposals. Free Cash Flow before acquisitions was $266 million compared to $65 million in the fourth quarter of 2005. A total of $118 million in cash was used for acquisitions.
Full Year 2006:
Earnings and Revenue
For the full year 2006, net income was $537 million, up 18% from 2005. Excluding costs related to the change of accounting principles for stock options (SFAS 123R) of $10 million and one-time items of $37 million, net income increased by 24% to $584 million. In the future, costs related to SFAS 123(R) will not be adjusted when comparing with 2007 figures.
Net revenue for 2006 was $8,499 million, up 26% from 2005. Adjusted for currency, net revenue rose by 25%. Organic growth was 10%.
Operating income (EBIT) increased by 40% to $1,318 million. Operating income for the full year 2006 includes expenses of $11 million as a result of restructuring and in-process R&D, transformation of legal form and the change of accounting principles for stock options, net of the gain from the clinic divestitures.
Excluding these items and the one-time costs for the transformation of the legal form in the prior year, operating income for 2006 increased by 38% to $1,329 million. This performance resulted in an operating margin of 15.6% compared to 14.2% for the year 2005.
Net interest expense for the full year 2006 was $351 million. The increase was the result of three quarters worth of additional interest expense and the write-off of deferred financing costs related to the 2003 senior credit facility of $15 million, both in conjunction with the financing of the RCG acquisition.
Income tax expense was $413 million for the full year compared to $309 million in 2005, reflecting tax rates of 42.8% and 40.3%, respectively. The tax rate was impacted by tax payments in connection with the gain on divestiture of dialysis clinics in the U.S. and by a tax audit in Germany. Excluding these impacts, the effective tax rate was 38.5%.
For the full year 2006, earnings per ordinary share rose by 17% to $5.47 ($1.82 per ADS). The weighted average number of shares outstanding during 2006 was approximately 98.1 million.
Cash Flow
Cash from operations during the full year 2006 was $908 million compared to $670 million for 2005 on a reported basis. On an adjusted basis, cash from operations was $1,106 million in 2006 compared to $805 million in 2005. The increase compared to prior the year was mainly due to increased earnings and further improvements in working capital efficiency.
A total of $450 million was used for capital expenditures, net of disposals. Free Cash Flow before acquisitions for 2006 was $458 million compared to $373 million in 2005. The underlying Free Cash Flow before acquisitions and one-time effects for 2006 was $656 million. A total of $159 million in cash was used for acquisitions other than the RCG acquisition in 2006.
For a complete overview on the fourth quarter and the full year of 2006 and the reconciliation of non-GAAP financial measures included in this release to the most comparable GAAP financial measures, please refer to the attachments.
Patients – Clinics – Treatments
As of December 31, 2006, Fresenius Medical Care treated 163,517 patients worldwide, which represents a 24% increase in patients compared to last year. North America provided dialysis treatments for 117,855 patients (up 32%). Including 33 managed clinics, the number of patients in North America was 119,883. The International segment served 45,662 patients (up 8%).
As of December 31, 2006, the Company operated a total of 2,108 clinics worldwide. This is comprised of 1,560 clinics in North America, an increase of 35%, and 548 clinics in the International segment, an increase of 5%.
Fresenius Medical Care delivered approximately 23.74 million dialysis treatments worldwide, which represents an increase of 20% year over year. North America accounted for 16.88 million treatments, an increase of 25%, and the International segment delivered 6.86 million treatments, an increase of 10% over last year.
Employees
As of December 31, 2006, Fresenius Medical Care employed 56,803 people (full-time equivalents) worldwide compared to 47,521 at the end of 2005. The increase of 9,282 employees is primarily due to the acquisition of Renal Care Group.
Dividends
The Company will continue to follow an earnings-driven dividend policy. For the tenth consecutive year, shareholders can expect to receive an increased annual dividend for the fiscal year 2006. At the Annual General Meeting to be held on May 15, 2007, shareholders will be asked to approve a dividend of €1.41 per ordinary share, an increase of 15% from 2005 (€1.23) and €1.47 per preference share, an increase of 14% from 2005 (€1.29).
Acquisition in Taiwan
On January 9, 2007, the Company announced the acquisition of a 51% equity interest in Jiate Excelsior Co. Ltd. ("Excelsior") in Taiwan. The purchase price for the 51% equity interest in Excelsior was $38 million. The transaction is expected to add about $80 million to the consolidated revenues and to be accretive to the Company's earnings for 2007. Through the transaction, Fresenius Medical Care will become the leading dialysis provider in the Asia-Pacific region.
Outlook for 2007
For the full year 2007, the Company expects to achieve revenue of approximately $9.4 billion, an increase of 11%.
The net income is expected to be between $675 million and $695 million in 2007. This represents an increase of between 18% and 21% on an adjusted basis to 2006. On a reported basis, the net income would increase by 26% to 29%.
The Company expects spending on capital expenditures and acquisitions to be at approximately $650 million. The debt/EBITDA ratio is expected to fall below 3.0 by the end of 2007.
Ben Lipps, Chief Executive Officer of Fresenius Medical Care, commented: "Our excellent financial performance for the year reflects the strong demand for our products and services worldwide. We are pleased to have again delivered on our commitments in 2006 and are proposing to deliver our tenth consecutive dividend increase to our shareholders. With the successful integration of the Renal Care Group acquisition, expansion opportunities for patient care in Europe and Asia and the progress on our growth initiatives, we are confident as we look ahead."
Video Webcast
Fresenius Medical Care will hold a press conference at its headquarters in Bad Homburg, Germany, to discuss the results of the fourth quarter and the full year of 2006 on February 22, 2007, at 10:00 am CET. The Company cordially invites journalists to view the live video webcast of the meeting at this website. A replay will be available shortly after the meeting.
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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 about 1,500,000 individuals worldwide. Through its network of 2,108 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 163,517 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
- Sales € 10.8 billion, + 37 % at actual rates, + 37 % in constant currency
- EBIT € 1,444 million, + 49 % at actual rates, + 50 % in constant currency
- Net income € 330 million, + 49 % at actual rates, + 49 % in constant currency
- Sales exceeding the € 10 billion mark and EBIT exceeding the € 1 billion mark for the first time
- Excellent sales and earnings growth in all business segments
- Further margin improvements in all business segments achieved
- 15 % increase in dividend per share proposed
- Strong cash flow supports rapid de-levering
14th consecutive dividend increase proposed
2006 was the most successful year in the Company's history. Based on the Group's excellent financial results, the Management Board will propose to the Supervisory Board a dividend increase of 15 % to € 0.57 per ordinary share (2005, adjusted for the share split: € 0.49) and to € 0.58 per preference share (2005, adjusted for the share split: € 0.50). The total dividend distribution is expected to be € 88.8 million (2005: € 75.8 million).
Positive outlook for 2007
For 2007, Fresenius Group projects further improvements in sales and earnings. Group sales are expected to grow by 8 to 10 % in constant currency. Net income is expected to increase by 20 to 25 % in constant currency. We anticipate further margin improvements of all business segments to contribute to this growth.
Investments in property, plant and equipment and in intangible assets are planned to increase from € 600 million in 2006 to € 600 to 700 million.
Strong sales growth across all business segments and regions
Group sales increased by 37 % to € 10,777 million in 2006 (2005: € 7,889 million). Organic growth was 9 %. Acquisitions, in particular Renal Care Group and HELIOS Kliniken, contributed 29 %. Divestitures had a -1 % effect on sales. Currency translation effects had no impact.
Strong sales growth was achieved in the core markets of North America and Europe. In North America, sales grew significantly due to the Renal Care Group consolidation and an excellent organic growth rate of 9 %. 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 19 % in Asia-Pacific, 22 % 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.
Excellent earnings growth
Group operating income (EBIT) increased by 49 % at actual rates and by 50 % in constant currency to € 1,444 million (2005: € 969 million). The Group EBIT margin improved to 13.4 % (2005: 12.3 %). Operating income for the full year 2006 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. Operating income for the full year 2006 also includes a total of € 44 million for one-time expenses, e.g. for the integration of Renal Care Group, as well as for expenses related to the stock option accounting change.
Group net interest was € -395 million (2005: € -203 million). The increase was primarily driven by the debt financing of the Renal Care Group acquisition. Net interest also includes one-time expenses of € 30 million associated with the early refinancing of Group debt.
The tax rate was 39.5 % (2005: 38.9 %). 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 37.2 %, well within our guidance of 36 to 38 %.
Minority interest was € 305 million (2005: € 246 million), of which 93 % was attributable to the minority interest in Fresenius Medical Care.
Group net income grew strongly by 49 % at actual rates as well as in constant currency to € 330 million (2005: € 222 million). Net income includes a total of € 29 million for one-time expenses, primarily for the early refinancing of debt, for the integration of Renal Care Group, and for expenses related to the stock option accounting change.
Earnings per ordinary share were € 2.15 (2005, adjusted for the share split: € 1.76) and earnings per preference share* were € 2.16 (2005, adjusted for the share split: € 1.77). This is an increase of 22 % for both share classes. The average number of shares grew to 153,006,012 in 2006.
* In accordance with SFAS 128 („Earnings per Share") the calculation of basic and diluted earnings per share for the fiscal years 2006 and 2005 have been adjusted retrospectively by the increased weighted average number of shares outstanding.
Capital expenditure at high level
Fresenius Group spent € 600 million for property, plant and equipment and intangible assets (2005: € 353 million). Acquisition spending increased to € 3,714 million mainly due to the Renal Care Group acquisition (2005: € 1,894 million).
Strong cash flow
Operating cash flow increased by 35 % to € 1,052 million (2005: € 780 million). Key drivers were the strong increase in earnings and further improvements in working capital management. Cash flow before acquisitions and dividends was € 481 million (2005: € 449 million). The acquisition of Renal Care Group was entirely debt-financed.
Solid balance sheet structure
Total assets increased by 30 % to € 15,024 million (December 31, 2005: € 11,594 million). In constant currency, total assets grew by 38 %. The substantial increase is mainly related to the consolidation of the Renal Care Group. Current assets increased by 16 % to € 4,106 million (December 31, 2005: € 3,531 million). Non-current assets were € 10,918 million (December 31, 2005: € 8,063 million), an increase of 35 %.
Shareholders' equity including minority interest grew by 12 % to € 5,728 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 38.1 % (December 31, 2005: 44.2 %).
Group debt increased to € 5,872 million (December 31, 2005: € 3,502 million) due to the financing of the Renal Care Group acquisition.
As of March 31, 2006, following the closing of the Renal Care Group acquisition, the net debt/EBITDA ratio was at 3.5. Given the excellent earnings growth and a strong cash flow the net debt/EBITDA ratio improved significantly to 3.0 as of December 31, 2006 (December 31, 2005: 2.3).
Employees
As of December 31, 2006, the Group had 104,872 employees (December 31, 2005: 91,971). The increase of 12,901 employees is primarily due to the acquisitions of Renal Care Group and HUMAINE Kliniken.
Fresenius Biotech
Fresenius Biotech develops innovative therapies with trifunctional antibodies for the treatment of cancer as well as cell therapies for the treatment of the immune system. In the field of polyclonal antibodies, Fresenius Biotech has successfully marketed ATG-Fresenius S for many years. ATG-Fresenius S is an immunosuppressive agent used to prevent and treat graft rejection following organ transplantation.
In December 2006, first results of a phase II/III pivotal study on malignant ascites in patients with ovarian cancer were published, including treatment data of 129 patients. The results showed a clear advantage of the therapy with the trifunctional antibody removab® over a therapy with puncture alone. The results of 128 patients with tumor diseases other than ovarian cancer (e.g. gastric cancer) are expected for the first quarter of 2007. Data on overall survival of all patients of the study are expected in the second quarter of 2007. The application dossier for marketing authorization for removab® in malignant ascites is planned to be submitted to the European Medicines Agency (EMEA) in the second half of 2007.
In June 2006, Fresenius Biotech published the results of a phase Ila study in the treatment of ovarian cancer patients assessing tolerability, dose regimen and efficacy. Based on the encouraging results, the company plans to start a phase II study in this indication in Europe in the first half of 2007.
The phase II study with the antibody rexomun® to treat breast cancer, which started in March 2006, and the phase II study with the antibody removab® to treat gastric cancer, which started in June 2006, are ongoing.
Fresenius Biotech's operating income (EBIT) was € -45 million in 2006 (2005: € -41 million). For 2007, Fresenius Biotech expects an EBIT of approximately € -50 million.
The Business Segments
Fresenius Medical Care
Fresenius Medical Care is the world's leading provider of products and services for patients with chronic kidney failure. As of December 31, 2006, Fresenius Medical Care was serving 163,517 patients in 2,108 dialysis clinics.
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* 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 successfully completed
- Outlook 2007: double-digit sales and earnings growth expected
Fresenius Medical Care achieved strong sales growth of 26 % to US$ 8,499 million (2005: US$ 6,772 million). This was mainly driven by the excellent organic growth of 10 % and the consolidation of the Renal Care Group. Sales in dialysis care increased by 31 % to US$ 6,377 million (2005: US$ 4,867 million). In dialysis products Fresenius Medical Care achieved sales of US$ 2,122 million (2005: US$ 1,905 million), an increase of 11 %.
In North America Fresenius Medical Care's sales increased by 32 % to US$ 6,025 million (2005: US$ 4,577 million). Organic growth of 9 % in this region was excellent. Sales outside North America ("International") grew by 13 % (12 % in constant currency) to US$ 2,474 million (2005: US$ 2,195 million).
Net income increased by 18 % to US$ 537 million (2005: US$ 455 million). This result includes one-time expenses of US$ 47 million primarily for the early refinancing of debt, for the integration of Renal Care Group, and 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 increased by 24 % to US$ 584 million.
For the full year 2007, Fresenius Medical Care expects revenue to be about US$ 9.4 billion. The net income is expected to be between US$ 675 million and US$ 695 million in 2007.
For further information, please see Fresenius Medical Care's Investor News at www.fmc-ag.com.
Fresenius Kabi
Fresenius Kabi offers infusion therapies and clinical nutrition for seriously and chronically ill patients in the hospital and out-patient environments. The company is also a leading provider of transfusion technology products.
- Strong organic sales growth of 8 %
- EBIT margin at new record levels in the fourth quarter and for the full year 2006
- Outlook 2007: strong margin growth and increase in earnings expected
In 2006, Fresenius Kabi's sales increased by 13 % to € 1,893 million (2005: € 1,681 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 7 %, in Germany by 5 %. Fresenius Kabi continued its exceptional growth outside Europe and achieved sales growth of 41 % in Asia-Pacific, 27 % in Latin America and 17 % in the other regions. Organic growth in the regions outside Europe was again well into the double digits.
Earnings at Fresenius Kabi reached new record levels: EBIT increased by 24 % to € 291 million (2005: € 234 million). The EBIT margin improved to 15.4 % in the full year 2006 (2005: 13.9 %). The original mid-term EBIT margin target of about 15.5 % by 2007 was therefore reached ahead of time. In the fourth quarter, the EBIT margin reached a new record level of 16.0 %. Net profit rose by 29 % to € 143 million (2005: € 111 million). This already includes one-time expenses of € 11 million for the early refinancing of the 2003 Euro Bond.
In 2007, Fresenius Kabi expects a positive sales and earnings performance. Organic sales growth is projected to be 6 to 8 %. Strong sales growth is anticipated again from the regions outside Europe. Based on the positive sales projection and further manufacturing and logistics improvements Fresenius Kabi expects an EBIT margin of 16.0 to 16.5 % in 2007.
Also for the mid-term, Fresenius Kabi expects to continue its positive financial performance: The company targets organic sales growth of 6 to 8 %. Further, Fresenius Kabi foresees its EBIT margin in the 16 to 18 % range.
Fresenius ProServe
Fresenius ProServe is a leading German hospital operator with 55 facilities. Moreover, the company offers engineering and services for hospitals and other health care facilities.
- Very good revenue and earnings development in the hospital operations business
- Strong order intake in engineering and services business
- Outlook 2007: Continued sales and earnings improvements expected
Fresenius ProServe's sales grew by 7 % to € 2,155 million in 2006 (2005 including HELIOS Kliniken: € 2,009 million). Organic growth was 3 %. EBIT increased by 23 % to € 154 million (2005 including HELIOS Kliniken: € 125 million).
Sales in hospital operations (HELIOS Kliniken Group) increased by 8 % to € 1,673 million (2005 including HELIOS Kliniken : € 1,550 million). The sales growth is mainly attributable to the acquisition of HUMAINE Kliniken, which was consolidated as of July 1, 2006. However, HELIOS also achieved strong organic growth of 3 %. EBIT increased to € 133 million, the EBIT margin improved to 7.9 % (2005 including HELIOS Kliniken: € 107 million and 6.9 %).
HELIOS continued its growth strategy in the German hospital market. In January 2007, the company has agreed to acquire two hospitals in North-Rhine Westphalia with a total of 333 beds and sales of about € 32 million in 2006. The acquisition still requires approval by the antitrust authorities.
Sales in the engineering and services business (VAMED, Pharmaplan) increased by 5 % to € 482 million (2005: € 459 million). EBIT rose by 14 % to € 25 million (2005: € 22 million). Order intake and order backlog continued to develop very positively: Order intake increased by 19 % to € 407 million (2005: € 341 million). Order backlog also grew by 19 % to € 428 million as of December 31, 2006 (December 31, 2005: € 360 million).
In December 2006, Fresenius ProServe 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. The approval by the antitrust authorities is expected in the first quarter of 2007. The sale of Pharmaplan is a further step by Fresenius ProServe to focus on its business with hospitals and other healthcare facilities.
Fresenius ProServe projects further improvements in sales and earnings. Future growth potential is mainly expected from hospital privatizations in Germany. For 2007, Fresenius ProServe forecasts organic sales growth of 2 to 3 %. EBIT is expected to increase to € 160 to 170 million.
Video Webcast
As part of the publication of our results for the fiscal year 2006, an analyst conference will be held at the Fresenius headquarters in Bad Homburg on February 22, 2007 at 1:30 p.m. CET (7.30 a.m. EST). All investors are cordially invited to follow the conference in a live broadcast over the Internet at www.fresenius-ag.com / Investor Relations / Presentations. Following the meeting, a recording of the conference will be available as video-on-demand.
Fresenius Group in Figures and Consolidated Statement of Income (US GAAP) see pdf file
Fresenius Medical Care AG & Co. KGaA today announced that it will propose a share split for both classes of shares (ordinary and preferred) in the ratio of 1:3 to the next General Shareholder Meeting on May 15, 2007.
The strong performance of the company in recent years has led to a sharp increase in the share price. The price per ordinary share is currently one of the highest in Germany's DAX index. A share split would significantly lower the price of the individual Fresenius Medical Care share. The proposed share split is intended to promote more trading activity in Fresenius Medical Care shares and to increase the shares' attractiveness for a broader group of investors.
Through a conversion of capital reserves, the subscribed capital of Fresenius Medical Care AG & Co. KGaA is first increased to €295.2 million. The subscribed capital is then divided into 291,449,373 ordinary shares and 3,711,435 preference shares. The new amount of the subscribed capital will then be €1.00 per share. After the share split, every holder of an ordinary share will hold three ordinary shares and every holder of a preference share will hold three preference shares. As a result of the share split, the price level will be reduced arithmetically without affecting the overall value for shareholders.
For American Depositary Share (ADS) Investors:
Fresenius Medical Care shares are traded on the New York Stock Exchange (NYSE) in (NYSE) in the form of ADSs. Currently, the ratio between the ordinary and preference ADS and the underlying ordinary and preference shares is 3:1, meaning that three Fresenius Medical Care ordinary or preference ADSs are the equivalent of one Fresenius Medical Care ordinary or preference share. Upon approval of the proposed share split and the registration with the commercial register, each Fresenius Medical Care ordinary or preference ADS will represent one Fresenius Medical Care ordinary or preference share.
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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 about 1,500,000 individuals worldwide. Through its network of 2,108 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to 163,517 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.