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Fresenius Medical Care AG & Co. KGaA

Investor Presentation Sep 20, 2007

165_ip_2007-09-20_044b9964-8713-473f-9c36-93654852c50e.pdf

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Shaping the Future of the Dialysis Industry Worldwide Dr. Ben Lipps, CEO & Chairman of the Management Board

Capital Markets Day

September 20-21, 2007

1. Company Today

2. Market Potential

3. Growth Strategy: Shaping the Future of Dialysis

4. Summary

World Leader in Products & Services

\$9 billion Products Market

31%Gambro16%Baxter22%Other31%Fresenius Medical Care2006

\$45 billion Services Market

Source: Company estimates

Industry's Only Vertically Integrated Provider

* including clinics where FME has in interest of at least 10% the amount of patients treated would be 10,994 patients in 144 clinics

Company: Management Structure

Ben Lipps

Chairman & Chief Executive Officer

Chief Executive Officer Europe, L. America, Middle East & Africa

Rice Powell

Co-Chief Executive Officer North America & President Renal Therapies Group

Chief Executive OfficerAsia Pacific

Mats Wahlstrom

Co-Chief Executive Officer North America & President Fresenius Medical Services North America

Decentralized Structure

Emanuele Gatti Roberto Fusté Lawrence Rosen

Chief Financial Officer

Rainer Runte

General Counsel & Chief Compliance Officer

Proximity to patients and customers

  • Awareness of local environment and needs
  • Focused activities
  • Local production & distribution facilities
  • Combination of more than 150 years in the dialysis industry

1. Company Today

2. Market Potential

3. Growth Strategy: Shaping the Future of Dialysis

4. Summary

Sustainable Patient Growth of 5-6% p.a.

~ 2 Million Patients Worldwide by 2010

Market Opportunity

1. Company Today

2. Market Potential

3. Growth Strategy: Shaping the Future of Dialysis

4. Summary

Growth Strategy 2007

Reduction in Crude Mortality Confirms Expectations from Single Use Paper

Horizontal Expansion

Renal Drug Initiative - Combine membrane, delivery and laboratory technology with proven dialysis drugs to provide superior outcomes

Horizontal Expansion

ESRD Patient

Total Dialysis Patients: 1.55 million

Source: Company Estimates

1. Company Today

2. Market Potential

3. Growth Strategy: Shaping the Future of Dialysis

4. Summary

Summary - Growth Drivers

Renal Pharma

Expansion of Clinic Network Revenue Growth per Year

Reimbursement Based on Quality

Increased Product Market Share

Product & Service Innovation

Global Patient Growth

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2010 Revenue Target

Sustainable Earnings After Tax Growth – Low to Mid-Teens

Capital Markets Day

September 20-21, 2007

1. North American Service Business

  • 2. Market Dynamics
  • 3. Key Strategic Objectives
  • 4. The Clinic of the Future
  • 5. Summary

Fresenius Medical Care North America Services Revenue

Fresenius Medical Care North America Days Sales Outstanding

Fresenius Medical Care North America Revenue and Cost per Treatment

RevenueExpenses

Significant Improvement in the Private Payor Mix

Fresenius Medical Care North AmericaPrivate Payor Mix

Successful Integration of RCG

  • •Successful integration of Cultures and People
  • •Continued to improve productivity during the integration process
  • •RCG Clinics Successfully Converted to Single-Use
  • •All Clinics will be UltraCare Certified by the end of 2008
  • •Significantly Exceeded Performance Expectations and Financial Model
  • • All Clinics will be using the same Information Systems by the end of 2010:
  • SAP (Accounting & Purchasing) Done
  • PeopleSoft (HR and Payroll) 2008
  • QMS/Medical Manager (Billing Systems) eCube 2009
  • AMI/Proton (Clinical Systems) eCube 2010

Fresenius Medical Care Services –Organization Structure

U.S. Dialysis Care (June 30, 2007)

1. North American Service Business

2. Market Dynamics

3. Key Strategic Objectives

4. The Clinic of the Future

5. Summary

Market Share in Provider Business

Market Share in 2006

DaVitaDialysis Clinics Inc. Renal Advantage Inc. National Renal Institute (DSI)

Fresenius Medical Care

American Renal Associates

Other Facilites

Source: Company Estimates

Market Share Development

North American Service Business –External Realities

  • •Market Growth 3.0-3.5%
  • •EPO Dynamics
  • •Commercial Payor Dynamics
  • •Increasing Nursing Shortage
  • •Payment Reform for ESRD ???

Fresenius Medical Care Strengths

  • •UltraCare
  • •Managed Care Team
  • •Cost Leadership
  • •Bench Strength
  • • Local Market Position
  • Clinic Network
  • • Best Positioned Provider in a bundle Environment
  • •Vertical Integration
  • •Asia Pacific Nursing Institute

1. North American Service Business

2. Market Dynamics

3. Key Strategic Objectives

4. The Clinic of the Future

5. Summary

Building Blocks for Strategic Positioning

Physician Strategies

Well Defined Internal Processes, Policies and Procedures

Fresenius Medical Services Strategy for the Continuum of Kidney Disease

Approximately 20 MillionAmericans withsome form ofKidney Disease

Growth Objective

• Organic Revenue Growth > 6% •Selective Acquisitions

  • •Private Payor Mix
  • •Managed Care Contracting
  • •Medicare Reimbursement
  • •Value Proposition for Physicians
  • •DeNovo Development
  • •Acute Contracting
  • •Recruiting of Nurses

Protecting our Market Position: De NovoDevelopments in the U.S.

~70-80 ~70-80~70-80

Economics of a De Novo

\$1.5-\$2.0 million per center

Double the ROIC of an acquisition

12-18 months to ramp up

1. North American Service Business

  • 2. Market Dynamics
  • 3. Key Strategic Objectives
  • 4. The Clinic of the Future

5. Summary

Clinic of The Future

eCubeTM Benefits Chart

  • •Patient-Centric Quality Improvements
  • •Significant Cost and Revenue Efficiencies
  • •Decrease in DSO
  • •Improved Physician Relationships
  • •Integrated Plan of Care/Disease Management Approach
  • • Clinical Care system closely integrated with 2008T Machine

eCubeTM Value Enhancement

PROBLEM IDENTIFICATION

PROBLEM RESOLUTION

eCubeTM Value Enhancement

Source: Company Estimates and Public Information

eCubeTM Value Enhancement

1. North American Service Business

  • 2. Market Dynamics
  • 3. Key Strategic Objectives
  • 4. The Clinic of the Future

5. Summary

Fresenius Medical Care Services -Summary

  • •Successful Integration of RCG
  • •Strong Strategic Platform
  • •Experienced Management Team
  • •Operational Bench Strength
  • •eCube will be Gold Standard in the Industry
  • •Integrated CKD Solutions
  • • Leveraging our Vertically Integrated Model by integrating Information Technology with Dialysis Technology
  • •Shifting our Focus to Acceleration of Growth

Shaping the Future of the Dialysis Products Market in North America

Rice Powell

Capital Markets Day

September 20-21, 2007

Renal Therapies Group

Agenda

  • I. Overview
  • •April 2005
  • •September 2007
  • II. Renal Therapies Group Portfolio
  • •Current Reality
  • •Future Growth Drivers
  • III. Summary

Fresenius Vision and Risk

  • • Fresenius focus on Intravenous Solutions…diversified in 1960's into innovative, high quality Dialysis Products…
  • • 1990's dialysis treatment consolidation fueled expansion into dialysis services… Vertical integration 1996
  • • Global Leadership in new millennium enhanced via conversion from re-use to single-use therapy…

Products & Hospital Group Vision: 2005

Vision:

Continue PHG Product and Lab Leadership in Renal Care, and expand to a "Blood Therapy Business"

  • • Drive and secure leadership in our core Renal business segment, i.e. dialysis products and laboratory services
  • •Expand Horizontally into Renal Pharmaceuticals
  • • Capitalize on new business opportunities in extracorporeal therapies and non-renal blood therapies which leverage PHG business competencies and diversify our commercial portfolio

Business Evolution: 2007

A refined Vision:

First Choice for Renal Therapies… enhancing the quality of lives

And Honed Strategic Imperatives:

  • Drive and secure leadership in our core Renal business segment
  • Capitalize on new business opportunities that leverage our expertise
  • Achieve Best Quality & Cost Leadership through Innovation and Best Practices
  • Build a high-performance culture that ensures individual and PHG success

Renal Therapies Group

Renal Therapies Group Portfolio

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Renal Therapies Group

Current Reality

  • •Major Market Share
  • •Knowledgeable, dedicated employees
  • •Segment approach to market opportunities

Market - Value Dialysis Products

Dialyzer North American Market Share - 2006

Canada

United States

Dialyzer North American Market Share - 2006

Single-Use Dialyzers

Strategy: Drive the independent market to single-use dialyzers

  • • Utilize single-use therapy bundle to meet clinical and economic expectations, branded as CarePak
  • Optiflux, high-flux dialyzers
  • Granuflo, dry acetate concentrate
  • CombiSet bloodlines
  • FMCNA manufactured saline

Renal Therapies Group

The Success of CarePak

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Machine North American Market Share -2006

Bloodline North American Market Share -2006

Concentrate North American Market Share - 2006

Renal Therapies Group – Production Facilities

Renal Therapies Group – Manufacturing

  • • Record production volumes
  • 34 million dialyzers (Ogden)
  • 62 million bloodlines (Reynosa)
  • 15,250 HD machines (Walnut Creek)
  • •Saline expansion & ramp on-track in Ogden

Renal Therapies Group – Operations Update

Renal Therapies Group – Product Quality approaching Six-Sigma

Renal Therapies Group – Product Quality

Renal Therapies Group – Spectra Laboratory Services

  • • Market leader in specialized lab services for renal care
  • • Largest ESRD–specific lab in the world
  • • 150,000 patients served
  • •44% of the Total market and
  • • 30% of the Independent market
  • • Phase II/ Phase III laboratory services for clinical trials

Today 2008 - 2010

  • • Key business growth drivers
  • Innovative IT solutions for all market segments
  • Measurement parameters for improved outcomes
  • • Elements of success
  • Quality
  • Reliability
  • The ability to deliver patientspecific data in a number of formats

Regulatory/ Reimbursement Environment

Foreseeable Regulatory Environment:

  • •The Bundle
  • • Vertical integration will provide the most effective integrated therapy

FDA

•More conservative requiring more infrastructure

Renal Therapies Group – Vision

Future Growth Drivers

What does success look like in 2008 – 2010?

  • Therapy Approach to Renal Disease
  • •Optimize leverage of vertical integration
  • • Ensuring individual and company success with a high-performance oriented culture

Success in 2008 – 2010: Vision

Therapy Approach to Renal Disease: Growth Drivers

Dialysis Treatment

Innovative Devices

Therapy Data Management

Electronic Data Interface solutions

Renal Drug Initiative

Portfolio Expansion

Disease Management

21 September – Robert Farrell, President & CEO Renaissance Health Care "Shaping the Future of Dialysis Payment Structure Worldwide"

Above Market Growth

Renal Drug Initiative

Capital Markets Day

September 20-21, 2007

Renal Therapies Group

PhosLo –Dispelling the Calcium Myth

12,000 FMS patients

Renal Therapies Group

PhosLo –Confirming the Phosphorus Story

12,000 FMS patients

PhosLo Positioning Strategy

The economics of PhosLo become even more significant when a bundling strategy by the Federal Government occurs. (EPO, Iron, & Vitamin D).

PhosLo Business Initiatives

  • •CARE 2 study
  • • Advisory meeting with FDA October 16 (pre-dialysis indication)
  • •New Formulations
  • •ASN Renal Week – 2007

Success in 2008 – 2010: Vision

Therapy Innovation

  • • Liberty Cycler – PD Therapy
  • Improves competitive position
  • • Low GDP Solution
  • Enhance patient therapy
  • • "Therapy Integration Module System" – HD Therapy
  • Acute and Home HD settings
  • Addressing the Voice of the Customer

In Summary…

Our company needs to continue evolving …

  • •We can not become complacent with where we sit today
  • •Evolving into a Renal Therapy-focused company

Capital Markets Day

September 20-21, 2007

Shaping the Future of Dialysis in Europe

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

1. Europe Market Overview

2. Reimbursement in Europe

3. Market Share and Sales

4. Outlook and Strategy

Market Overview: The EMEA Dialysis Market Represents a \$16 billion opportunity

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EMEA Market Development – Services and Products: 4.3% Growth per Annum '02 to '07

Still mainly public but changing rapidly

1. Europe Market Overview

2. Reimbursement in Europe

3. Market Share and Sales

4. Outlook and Strategy

Dialysis in Europe: Not an homogeneous picture

Healthcare expenditure as percentage of GDP Dialysis prevalence (p.m.p.)

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Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Reimbursement Structures and Rates Vary Widely Across Europe

Structure

  • • Who is eligible for reimbursement for provision of dialysis service
  • • How financial resources are distributed to providers

Rates per treatment can vary by more than 100% within Europe. Rates variation is influenced mainly by:

Dialysis Services are provided in 16 languages with ~ 50 different rates by an uncounted number of payors.

Dialysis Reimbursement Structure – Source of Funding

Dialysis Reimbursement Rates – Components Included

Core disposables MachinesInfrastructurePhysician fees Nursing service Standard pharmaceuticals (e.g. heparin, analgesics)

Special pharmaceuticals (e.g. EPO, iron, phosphate binders) Diagnostics Laboratory works (Labs) Nutritional products Vascular accessTransportation Hospitalization Generally separately reimbursed

* Countries analyzed: Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Luxembourg, Poland, Portugal, Romania, Slovenia, Slovakia, Spain, Sweden, The Netherlands, Turkey and the United Kingdom

Dialysis Reimbursement Rates – Provider Type

Belgium, Denmark, Finland and Luxembourg

Dialysis Reimbursement Rates - Treatment Mode

HD

  • Standard HD
  • HF/HDF*
  • on-line HF/HDF*

*Hemofiltration/Hemodiafiltration

PDCAPDAPD

Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Hungary, Ireland, Luxembourg, Poland, Romania, Sweden, The Netherlands, Turkey

Austria, Estonia, Germany, Greece, Hungary, Ireland, Romania, Slovenia

Czech Republic, Greece, Italy, Portugal, Slovakia, Slovenia, Spain, United Kingdom

Belgium, Czech Republic, Denmark, Finland, France, Italy, Poland, Portugal, Slovakia, Spain, Sweden, The Netherlands, Turkey, United Kingdom

Dialysis Reimbursement Rates – Location of Treatment

**Limited care dialysis not allowed

Limited care and home dialysis not Source: FME internal analyses allowed

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Dialysis. Limited care not allowed. * Reimbursement not defined for Home Dialysis and/or for Limited-Care Dialysis.

1. Europe Market Overview

2. Reimbursement in Europe

3. Market Share and Sales

4. Outlook and Strategy

FME is the Leading Private Dialysis Provider in EMEA

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FMC Growth in Dialysis Care: from 5,600 to 26,100 Patients

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Number of Patients Treated Continues to Grow

1999 - 2007 FME Patients Development in Western and Eastern Europe

  • Growth above market both in Western Europe and Eastern Europe
  • Higher growth in Eastern Europe vs Western Europe will persist

Mortality risk for patients receiving hemodiafiltration versus hemodialysis: European results from the DOPPS

B Canaud, J L Bragg-Gresham, M R Marshall, S Desmeules, B W Gillespie, T Depner, P Klassen and F K Port

This prospective study involving 5 European countries investigated the influence of different dialysis treatment modalities (low- & high-flux HD, low- (exchange rate 5 – 14.9 L) & highefficiency (exchange rate 15 – 24.9 L) HDF) on the mortality risk of dialysis patients.

The participating 2165 patients were randomly assigned to one of the four above mentioned groups. The results were adjusted for age, gender, time on dialysis, comorbid conditions, weight, haemoglobin, Kt/V etc.

Europe, Middle East, Africa: Market Share

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Leading with product excellence, building credibility

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Page 98

Growing Market Share in All Dialysis Products - EMEALA

Baxter

Capital Markets Day September 20-21, 2007 Dialysis in Europe Author: Emanuele Gatti F © 2007 Fresenius Medical Care

Baxter4%

Other30%

Successful Development of Market Niches CRRT Business in Europe, Middle East, Africa: Growth far above Market

Multifiltrate:Proven Reliability

Dialysis Filters – Applied Nano Technology plasmaFlux Dry Membrane in Detail

  • • Membrane-plugging is prevented or noticeably delayed by the special morphology of the double-layer membrane
  • • Surface layer: Closure of the pores by blood cells is avoided at the surface layer.
  • • Filtration layer: Separation of lipoproteins from plasma

plasmaFlux dry membrane in detail

  • • Inner diameter 325 μ m
  • • Wall thickness 60 μ m
  • •Double layer structure
  • •New spinning nozzle

plasmaFlux dry membrane: double-layer structure in profile

Europe, Middle East, Africa: Revenue and EBIT Margin

Proven Track Record of EBIT margin in the bandwidth of 17.5% to 20%

1. Europe Market Overview

2. Reimbursement in Europe

3. Market Share and Sales

4. Outlook and Strategy

Shaping the Future of Dialysis in Europe – Critical Success Factors

  • Clinical excellence
  • –Treatment quality control and continuous improvement
  • Higher standards of care setting (ol-HDF)
  • Operation Excellence
  • Efficiency in resources utilization
  • –Uncompromised quality
  • Management and Organizational Excellence
  • –Common management platform (Nephrocare Excellence)
  • Share of best practice
  • Local management with detailed knowledge of country regulations

Europe, Middle East, Africa: Patient Care Targets

  • • In Europe, Fresenius Medical Care has assumed market leadership by continuously introducing innovative products of the highest quality
  • • Fresenius Medical Care has utilized its experience to build the strongest international network of dialysis centers, demonstrating highest standards of patient care combined with operational excellence
  • • The future of dialysis in Europe will be based on the synergy between product innovation and continuous improvement in the quality of care

Capital Markets Day

September 20-21, 2007

1. Asia-Pacific Market Overview

2. Asia-Pacific Reimbursement

3. Market Share and Sales

4. Outlook and Strategy

Fresenius Medical Care Growth Opportunities in Asia-Pacific

Revenues by Region 2006 Dialysis Patients by Region 2006

FME Group Total: \$8.5 billion Worldwide: 1.55 million

Worldwide Dialysis Patients 2006 Key Asian Markets

Country Population
in mio.
% of World
Population
Dialysis
Patients in
thds.
% of Total
Dialysis
Patients
Dialysis
Prevalence
United States 300 5% 340 22% 1,130
Japan 127 2% 271 18% 2,130
Brazil 189 3% 77 5% 140
Germany 82 1% 71 5% 870
China 1,318 20% 59 4% 45
Italy 0 1% 47 3% 820
Taiwan 23 0.4% 45 3% 1,950
Mexico 108 2% 42 3% 390
Turkey 73 1% 42 3% 580
South Korea 49 1% 38 2% 780
France 61 1% 34 2% 560
Egypt 80 1% 33 2% 420
India 1103 17% 25 2% 23
Argentina 40 1% 24 2% 600
United Kingdom 61 1% 23 1% 370
Countries 16 - 140 2,589 40% 376 24% 145
Countries 141 - 232 280 4% $\bf{0}$ 0% 0
Totals 6,400 100 1,550 100% 240

Source: FME Research

Asia-Pacific –ESRD Patients 2006

Capital Markets Day September 20-21, 2007 Dialysis in Asia Pacific Author: Roberto Fusté F © 2007 Fresenius Medical Care

Asia-Pacific –Total Market Value

Capital Markets Day September 20-21, 2007 Dialysis in Asia Pacific Author: Roberto Fusté F © 2007 Fresenius Medical Care

1. Asia-Pacific Market Overview

2. Asia-Pacific Reimbursement

3. Market Share and Sales

4. Outlook and Strategy

Reimbursement Overview

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Development in Taiwan

Strong leadership in all HD products

HD product value market share of >40% in 2007

Major expansion of services business through the acquisition of Jiate Excelsior with 90 clinics

–Integration successfully completed

HD patient market share (company owned) increased from 17% in 2006 to 72% in 2007

Revenues of \$164 mio and 1,384 mio treatments on 9,200 patients in 113 clinics (consolidated + unconsolidated centers) forecast for 2007

Several De Novos and Acquisition projects planned for 2008

China Healthcare System Overview

Medical Institutions / Hospitals

  • –Approx 67,000 medical institutions/ hospitals, categorized in classes
  • –Only Class II & III hospitals (6,500 hospitals) offer dialysis treatments

Reimbursement / Tender Process

  • Reimbursement schemes vary from city to city
  • Average reimbursement per treatment: Shanghai RMB 400, Beijing RMB 480
  • •Typical co-payment for HD patients:
  • • Urban patients:
    • Inpatient 5-15%
    • Outpatient 10-20%
  • •Rural patients: 30-60%
  • No standard product tender/bid process; each province and city has its own

China: Public Health Care Coverage Expanded to All Urban Inhabitants

Social / Medical Insurance Coverage

  • 1998: Health insurance program for the urban employee; 162 million people covered by March 2007
  • • 2003: Cooperative health care program for some rural residents; 140 million people covered by 2006
  • •Free health insurance for government employees
  • 23 July 2007: Announced the introduction of national health insurance program for ALL urban residents (including children and the unemployed)
  • Program finance by the Central Government
  • 79 cities to launch pilot by the end of September
  • Targets full urban coverage by 2010
  • An additional 200 million urban residents will be insured

21 July 2007 Chinese Premier Wen Jiabao on an early Saturday morning visited a community medical service center to see how basic medicare for urban residents works

China Healthcare System Overview (cont'd)

  • Update 6 September 2007:
  • Government will phase out the drug sales approach for sustaining health service as part of the healthcare reform
  • Drug costs currently make up for 44% of total medical expenditure in China
  • For the first time, a top health official (Minister of Health, Chen Zhu) is talking about the blueprint guiding China's Health Reform
  • The state council has set up a team from 16 ministries to work on the blueprint
  • "The government will increase funding to the healthcare sector and work out a proper pricing mechanism which better reflects the value of medical services"(Chen Zhu)
  • Rural Cooperative Medical Insurance System currently covers 83% of rural population, i.e.720 million
  • Chen Zhu forecasts universal coverage by 2009

India Reimbursement & Tender Process

Reimbursement – Current

  • •Dialysis treatment is currently not reimbursed
  • • Exception: limited number of patients that are government or ex-government employees (\$59 per treatment, including renal drugs) or employees from nationalized industries (e.g. Indian Railways)
  • • Renal patients from this segment represent less than 2% of the overall dialysis patient base

Reimbursement – Trend

  • •No change in the last five years
  • •No change expected in the near future
  • • Private health insurance is in its infancy, and dialysis treatment is not included in standard policies

Product Tender Process

  • • Majority tenders are decentralized
  • Individual hospitals are free to tender for their own requirements/ Funding by State Government
  • • Exceptions: strategic and nationalized departments handled by the Central Government (e.g. Defense, Railways)
  • •Two-part bid: Technical Bid (product description) and Commercial Bid

Japan: Acquisition Opportunities Might Open Up Following Policy Change

Dialysis Services

  • •Only physicians can legally own, manage and operate a clinic
  • • Government is reviewing its policy that might result in an opening up of the provision of medical services by companies in the foreseeable future
  • •FME currently provides consulting services to dialysis centers

Reimbursement

  • •Scheme reviewed every 2 years, bi-annual healthcare cuts
  • •Operating on a 'component system' depending on treatment modes
  • • Reimbursement cut April 2006:
  • Dialyzers: 5-40%, depending on dialyzer class
  • FME dialyzers: 16-19%
  • PD Bags: 5%
  • Clinics: 2-7.5% per treatment
  • •Next review: April 2008

1. Asia-Pacific Market Overview

2. Asia-Pacific Reimbursement

3. Market Share and Sales

4. Outlook and Strategy

Asia Pacific Ten Year Growth –Revenue

Asia Pacific Ten Year Growth –Dialysis Care

FME Product Market Share – 2007 vs 2001

In %

HD Machines (quantity) Concentrates* (value)

AP Dialysis Care Landscape 2007

1. Asia-Pacific Market Overview

2. Asia-Pacific Reimbursement

3. Market Share and Sales

4. Outlook and Strategy

Different Segments Needing Different Growth Strategies

Top 8 Growth Countries for (Potential) Services Business

Key Strategic Activities – Dialysis Care

  • • Integration of Jiate Excelsior in Taiwan (6,500 patients)
  • • Establish NephroCare Business Services in China
  • •Expand South Korea clinics base
  • • Establish premium clinics in top 8 cities in India
  • •Continue growing dialysis care in Australia

Key Strategic Activities – Dialysis Products

  • • Continue expanding HD leadership throughout the whole region
  • • Continue strong growth in Home Therapies in key countries

Home Therapies in Asia Pacific Strategic View

  • • PD is slowing down in developed markets (e.g. Japan, South Korea)
  • • PD is growing in developing markets with low reimbursement (e.g. China, India)
  • •HHD is fully established in Australia and New Zealand
  • •Key HHD projects in Korea and Hong Kong
  • • Home Therapies is under represented in Asia-Pacific and will continue growing throughout the region

HHD = Home Hemodialysis

Key Strategic Activities – Production

Key Strategic Activities – New Business

Summary Financial Targets 2008 - 2010

Key Strategic Activities

Dialysis Care

  • • Integration of Jiate Excelsior
  • • Consolidation of Service Business Taiwan
  • • Community Centers in China
  • • Expand South Korea and Japan
  • •Start pilot in India

  • • Expand HD Leadership

  • Launch PD China
  • • Alliance / Partnership in Japan

  • Expand Bloodlines & Concentrates
  • Activities
  • • Leverage Vertical Integration
  • •Expand Home HD

New Business

  • •RDI
  • •FIDN Roll Out
  • • Expand Acute Dialysis Business

Production

  • • Start up China Plant
  • •FX Line Japan

  • Other Manufacturing Opportunities
  • Indonesia
  • India
  • Malaysia

Conclusion

  • • The strong economic development and high population in Asia Pacific makes this region an attractive high potential for dialysis business
  • • Economic development allows higher government funding on healthcare in general, and dialysis care in particular
  • • FME in Asia Pacific is strategically positioned as the leading renal care company in products and services, capitalizing on the region's high growth potential and opportunities

Raymond M. Hakim, MD, PhD. Shaping the Clinical Future of Dialysis Worldwide

Capital Markets Day

September 20-21, 2007

Agenda

  • •Worldwide ESRD Incidence and Prevalence
  • •Mortality Trends in US and Worldwide
  • •Treatment Guidelines
  • • Opportunities to Improve Dialysis Treatment and Patient Outcomes
    1. Dialysis Membrane
    1. Dialysis Technology
    1. Mineral Metabolism
    1. Anemia Management
    1. Nutrition
    1. Vascular Access
  • •Impacting Growth in FME Clinics

Growth in Number of Dialysis Patients Worldwide

  • Renal failure persists as a chronic worldwide epidemic
  • Dialysis is the primary treatment modality for renal failure on a global scale
  • Exponential growth trend continues on a global scale as incidence (new cases) and patient survival improve.

Number of Dialysis Patients in Different Countries

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Source: FME Market and Competitor Survey, 2006

Prevalence of ESRD (per million population), 2004

Data presented only for those countries from which relevant information was available. All rates are unadjusted. Incident data from Israel, Jalisco, Japan, Luxembourg, Pakistan, the Philippines, & Taiwan are dialysis only.

2006 ADR - USRDS

Incidence of ESRD (per million population), 2004

Data presented only for those countries from which relevant information was available. All rates are unadjusted. Incident data from Israel, Jalisco, Japan, Luxembourg, Pakistan, the Philippines, & Taiwan are dialysis only.

2006 ADR - USRDS

Capital Markets Day September 20-21, 2007 Shaping the Clinical Future of Dialysis Author: Raymond M. Hakim, MD PhD F © 2007 F Page 143 resenius Medical Care

Diabetes as Cause of ESRD

Capital Markets Day September 20-21, 2007 Shaping the Clinical Future of Dialysis Author: Raymond M. Hakim, MD PhD F © 2007 F Page 144 resenius Medical Care

Average Age Increase of US Dialysis Patients

Average Age of Incident US Patients

Every 2 years the age of incident patients increases by 1 year

Source: USRDS 2006 Annual Report

Capital Markets Day September 20-21, 2007 Shaping the Clinical Future of Dialysis Author: Raymond M. Hakim, MD PhD F © 2007 F Page 145 resenius Medical Care

Mortality Rates by Modality for Different Dialysis Vintage

2007 ADR - USRDS

Mortality Trends in the US

  • • Despite increase in age and diabetes of incident patients in the US, mortality for dialysis patients is decreasing, starting in 1984 – 1985
  • • Exception is mortality for incident patients in the first year (This 1st year mortality does not take into account mortality in the first 90 days of dialysis)
  • • Pilot program of "RightStart" has shown significant improvement in outcomes in initial 90 day mortality, that extends up to one year after start
  • • "RightStart" program expanding within Fresenius Medical Care North America

Mortality Difference between U. S. and Europe

  • • No central mandatory registry in Europe, like USRDS, so comparisons of outcomes are difficult
  • • After adjusting for age, race, gender, and diagnosis, there are still mortality differences between the US and Europe (lower in Europe). Such differences may be due to:
    1. Prevalence of catheter rates (much lower in Europe).
    1. Generally a higher degree of compliance with treatment.
    1. Availability of nutritional supplements and meals in Europe.
    1. A higher proportion of professional (RN's) staff in Europe.
    1. A less heavy regulatory burden in Europe.
    1. Less patient selection in the US.
    1. A higher CVD burden in the US general population.
    1. Mortality higher in Diabetics, compared to non-diabetics (30% higher). Therefore, prevalence of diabetic ESRD patients influences mortality rates in each country. Prevalence of diabetics in the US is higher than Europe (obesity prevalence).

Difference of Clinical Protocols betweenEurope and U.S.

  • • In the U.S. KDOQI guidelines are almost universally accepted as "consensus" recommendations; in Europe, the equivalent is "European Best Practices Guidelines"
  • • Differences in guidelines and targets are small and may be reduced by efforts to establish Global Best Practices (KDIGO) – Kidney Disease Improving Global Outcomes).
  • •Differences also reflect reimbursement and economics issues

Areas to Improve Dialysis Outcomes

We will discuss each briefly

Capital Markets Day

September 20-21, 2007

Trends in Dialyzer Membrane

Technology – Four Decades of Development

HEMO-Study: Cardiac Death and Flux

1 A. Studies Showing Less Mortality with High-Flux Membranes:

Krane V, et al.

Dialyser membrane characteristics and outcome of patients with type 2 diabetes on maintenance haemodialysis.. Am J Kidney Dis. 2005;45(3):565-571.

Dialyzer Membrane Permeability and Survival in Hemodialysis Patients

Capital Markets Day

September 20-21, 2007

Uraemic Solutes Retained in Renal Failure "Uraemic 'Toxins"

Low-MW molecules (< 500 D) From: Vanholder et al, EUTox Work Group, Kid Int, Vol 63; 1934-1943 (2003)

  • - Water-soluble (non-protein-bound): e.g. urea (60 D), creatinine (113 D),
  • - Protein-bound:

Middle- Molecules

guanidines, oxalate, uric acid,

e.g. p-cresol (108 D), indoxyl sulfate (251 D),

phenol, indoles, hippuric acid, homocysteine

(500 - 12 000 D) e.g. parathyroid hormone (9 223 D), peptidelinked AGEs, ß 2-microglobulin (11 800 D)

High-MW solutes (> 12 000 D) e.g. leptin (16 kD), complement factor D (24 kD)

Current Dialysis Therapies

In Clinic:

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KPI #2: Convective Treatment in FME Clinics (EuClid Database)

Capital Markets Day

September 20-21, 2007

Mineral Metabolism

  • IT'S THE PHOSPHORUS
  • •Phosphorus control to KDOQI target remains poor.
  • •Phos-Lo most effective therapy for Phosphorus and PTH.
  • •Therapy with Phos-Lo impacts serum calcium level minimally
  • • Increasing use of Cinacalcet to control PTH favors the use of Phos-Lo, because of hypo-calcaemic effects of Cinacalcet (from reduced calcium absorption).
  • • Total calcium intake can be adjusted best with changes in dialysate calcium levels.

Relative Risk of Mortality: Phosphorus

Calcium and Phosphorus Control and KDOQI Target

Plasma Calcium Level and Phos-Lo Intake

Relative Risk of Mortality: Albumin-Corrected Calcium

Impact of Dialysate Calcium on Plasma Calcium

Capital Markets Day

September 20-21, 2007

The Effects of Higher Hemoglobin levels on Mortality and Hospitalization in Hemodialysis Patients

Anemia Management: Data on Number of Hospitalizations

Variability of monthly hemoglobin

Figure 5.41

FDA Update on Anemia Target

  • • Data from FMC-NA and other (Amgen, DaVita, RPA) presented at FDA-Advisory Panel on September 11, 2007.
  • • Data instrumental in vote of panel to:
  • Oppose lowering upper range of hemoglobin target below 12.0 g/dl.
  • Oppose FDA's recommended upper target of 11.0 g/dl.
  • • FDA not required to follow advisory panel recommendation (but it typically does).
  • •FDA will finalize changes to package insert in "weeks, not months".

Capital Markets Day

September 20-21, 2007

Relative Risk of Mortality: Albumin

Contribution of Variables to Predictive Power of the Final Cox Model for Mortality Risk in 2004

Capital Markets Day

September 20-21, 2007

Relative Risk of Mortality: Vascular Access

Capital Markets Day

September 20-21, 2007

Improving Haemodialysis' Patient Survival and Patient Growth

  • A. Near Term
    1. High flux Biocompatible dialysis and on-line haemodiafiltration
    1. Improved Phosphorus Control
    1. Improving nutritional parameters
    1. Reduction of catheters and increasing fistulae rate
  • B. Long Term
    1. Wearable artificial kidney
    1. Anti-oxidant therapy to lower cardiovascular risk

Increase preference by nephrologists to have their patients treated in FMS dialysis units by:

    1. Developing partnership with physicians
    1. UltraCare as a standard of care in FMC-NA facilities
    1. Active engagement with academic training center
    1. Treatment Options Education
    1. Advisory Boards (Medical, Nursing, and Dietitians)
    1. RightStart Program
    1. Clinical Research Initiatives

Capital Markets Day

September 20-21, 2007

Shaping the Future of the Dialysis Industry Payment Structure

Implications for Integrated Disease Management and Bundled Payment Approach Robert Farrell

Capital Markets Day

September 20-21, 2007

1. Cost of Care for ESRD Patients

2. Statistics

3. Renal Disease Management: Demo Project US

4. Renal Disease Management: Demo Project UK

5. Conclusion

Cost of Care for ESRD Patients

ESRD Demo Project – Member Total Annual Cost \$72,000 (2006 Financial Data)

  • Dialysis (38.5%)
  • Hospital (31.3%)
  • Hospital OutPatient (5.8%)
  • Nephrology (3.8%)
  • Surgery (4.3%)
  • Specialty (4.5%)
  • Lab/Path/Rad (3.5%)

Home Health/DME/Ambulance/Other (8.2%)

1. Cost of Care for ESRD Patients

2. Statistics

3. Renal Disease Management: Demo Project US

4. Renal Disease Management: Demo Project UK

5. Conclusion

Statistics: Adjusted Hazard Ratio of Death, Cardiovascular Event and Hospitalization among 1,120,295 Kaiser Permanente members according to estimated GFR*

Risk of Mortality and Hospitalization Increasing with Reduced Kidney Function

*Adjusted for age, sex, income, education, dialysis, prior CHD, CHF, stroke, TIA, PVD, DM, HT, dyslipidaemia, cancer, albumin <35, dementia, chronic liver disease, chronic lung disease, proteinuria, prior hospitalisations, published in New England Journal, 2004

Statistics: Estimated Prevalence of Complications Related to CKD

According to the Estimated GFR in the General Population

Stevens et al. N Engl J Med 2006

Statistics: Chronic Kidney Disease (CKD)

  • The majority of patients with CKD 3-4 will die of cardiovascular disease before they get to dialysis
  • About 10% of patients with CKD progress to ESRD
  • 30-50% of patients start dialysis with < 3 months nephrology care. They have:
  • Higher morbidity and mortality
  • Higher hospitalization rates

Statistics: Summary

  • High co-morbidity in ESRD population
  • Cardiovascular disease
  • Diabetes
  • Vascular access complications
  • Inflammation / Infection
  • Malnutrition
  • Case management approach needed, but fragmented reimbursement system at odds

1. Cost of Care for ESRD Patients

2. Statistics

3. Renal Disease Management: Demo Project US

4. Renal Disease Management: Demo Project UK

5. Conclusion

CMS ESRD Demo Project

  • •Four year project (2006 through 2009)
  • •Operated as a Medicare Advantage Health Plan
  • • Objective is to improve ESRD patient outcomes and reduce total patient care costs to Medicare
  • •Risk adjusted payment system (per co-morbidities)
  • • Fresenius Medical Care Health Plan (FMCHP) utilized a hybrid private fee for service Medicare Advanced Plan Model
  • • Plan did not include Part D Benefit (Patients enrolled in stand-alone Prescription Drug Plan [Part D])

CMS ESRD Demo Project: FMCHP Patient Benefits

Additional to Medicare Fee for Service

  • •Care manager and Disease Management
  • •Modest dental and vision benefits
  • •No co-payment on diabetic testing supplies
  • •Nutritional supplements
  • •Transportation benefit for Vascular Access procedure

CMS ESRD Demo Project: Results to Date

  • • Enrollment reached 550 patients by year end 2006 and 900 patients by midyear 2007 (10 markets)
  • •Medical loss ratio of approximately 89% achieved
  • • Quality indicators surpassed national averages and generally met improvement targets
  • •Approximately 50% of patients qualified and received nutritional support
  • • Hospital admissions below USRDS historical levels and averaged 1.5 admission per patient per year (PPPY) for first eighteen months of the demo project

CMS ESRD Demo Project: Patient Hospital Admissions

USRDS = United States Renal Data System

CMS ESRD Demo Project: Quality Targets Achieved

Q
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Indicator
AV Fistula
Calcium (ALB)
Catheter
HGB
Phosphorus
spKt/V
Achieved National Target
Yes
Yes
Yes
Yes
Yes
Yes
Achieved National Target
Yes
Yes
Yes
Yes
Yes
Yes

QIP: Quality Improvement Payment

1. Cost of Care for ESRD Patients

2. Statistics

3. Renal Disease Management: Demo Project US

4. Renal Disease Management: Demo Project UK

5. Conclusion

UK CKD Demo Project

Overview / Objectives

  • •Project duration from 2005 through mid 2006
  • •Demo Site West Lincolnshire Primary Care Trust
  • •Identify patients with CKD (in Primary Care Practices)
  • •Implement a nurse led, Primary Care based Disease Management program
  • •Risk assess all CKD Stage 4 and 5 patients
  • •Reduce unplanned hospitalization
  • •Improve Vascular Access at dialysis commencement
  • •Improve vaccination uptake

UK CKD Demo Project

Results

  • •Reduced Emergency Room attendances by 54%
  • •Reduced outpatient visits by 60%
  • •Reduced unplanned admissions by 64%
  • •Reduced days in hospital by 57%
  • •89% of patients with falling Glomerular Filtrition Rate (GFR) improved

UK CKD Demo Project

Results continued: Demo project was successful in terms of quality and economics:

  • •Increased patient identification – 15 fold
  • •Reduced mortality from 21% to 10%
  • •Reduced crash landing from 38% to 25%
  • •Improved blood pressure control
  • •Improved cholesterol control
  • •Leading to 30% reduction in cardiovascular risk

1. Cost of Care for ESRD Patients

2. Statistics

3. Renal Disease Management: Demo Project US

4. Renal Disease Management: Demo Project UK

5. Conclusion

Conclusion:Current Situation / Opportunity

CKD patients are still largely inadequately managed

  • • Disease Management opportunity to:
  • Identify CKD patients earlier in the disease path
  • Improve outcomes, increase survival and provide better preparation for dialysis

ESRD patient population has high co-morbidity

  • • Disease Management opportunity to:
  • Improve patients outcomes by managing co-morbid conditions (case management approach)
  • Reduce ESRD mortality

Renal Disease Management can improve the organic dialysis patient growth rate

Conclusion: Potential Integrated Care Business Models

Conversion of Demo Project Experience to a Special Needs Plan (SNP)

  • • SNP - Medicare Advantage
  • Requires reauthorization of chronic SNP authority by Congress
  • Current SNP Authority sunsets as of Dec 31, 2008
  • Will target dual patients (Medicare primary/ Medicaid secondary)
  • Decision point for Fresenius Medical Care North America will be mid-late 2008 for implementation post demo project (2010)

Provide DM Services to Medicare Fee for Service

  • DM fees at risk against total cost savings to Medicare
  • Share of cost savings between Fresenius Medical Care and Medicare

Market size at 89% Medical Loss Ratio (MLR) on 300,000 Medicare ESRD Patients is approximately \$2.5 billion

Similar Models can be applied outside of US

Capital Markets Day

September 20-21, 2007

1. Historical Highlights

2. Financial Targets

3. Key Non-Operating Initiatives

4. Summary

Historical Highlights

Topline Growth Drivers: Revenue

  • •Market Share Gains
  • •Revenue Per Treatment Increases
  • •Geographical Mix Management
  • • Successful Execution of Acquisition and Integration Strategy

Historical Highlights

18 Quarters of Meeting or Exceeding Market Expectations

Earnings Growth Drivers: Net Income

  • •Scale Effects
  • •Revenue Per Treatment Increases
  • •Manufacturing Performance
  • •Product Mix
  • •Clinic Cost Control
  • •Favorable Financing Conditions
  • •Slightly Lower Tax Rate

Historical Highlights

Balance Sheet and Cash FlowGrowth Drivers:

Operating Cash Flow

  • • Excellent Working Capital Management
  • • Strong Operating and Free Cash Flow
  • •Increasing Net Income Levels
  • • Cash Inflow from Share Conversion and Divestitures

1. Historical Highlights

2. Financial Targets

3. Key Non-Operating Initiatives

4. Summary

2010 Objectives – Revenue Average Annual Growth

2010 Objectives – EBIT margin

  • •Scale effects
  • •RDI effect
  • •Strict cost control
  • •Strategic investment / placement

US: De novos Payor mix International: More profitable countries

•Manufacturing capacity / demand management and efficiencies

  • •Eliminate high cost subordinated tier
  • • Continue de-leveraging to reduce overall interest and credit margins
  • • Opportunistically increase variable rate exposure following de-leveraging and efficiencies

  • •Review potential for a captive insurance subsidiary

  • •Intellectual property ownership
  • • Close open tax items and reduce interest effects included in tax note

2010 Objectives – Net Income / EPS

2010 Objectives – Cash from Operations

  • •Improve profitability
  • • Continue with effective working capital management
  • •Strong collection process
  • •Further optimize inventory management

  • •Take advantage of the existing growth opportunities

  • •Prudent investment to avoid dilution of return on invested capital

1. Historical Highlights

2. Financial Targets

3. Key Non-Operating Initiatives

4. Summary

Capital Structure

  • •FME should target a Debt/EBITDA ratio of 2.5 – 3.0x
  • • Roughly equivalent to a credit rating of BBB- to BB:
  • Industry well suited to "reasonable" leverage
    • •Non-cyclical
    • •Predictable cash flow
    • •Attractive profitability
    • •Foreseeable investment needs
  • WACC minimized at 2.5 3x

Capital Structure continued

  • • FME may reach lower end of target leverage range in next 12 – 18 months
  • • At that point, alternatives that could be considered are:
  • –Further reduce leverage
  • Seek further investment opportunities
  • (i.e. above 7% of revenue)
  • Increased return of cash to shareholders

Interest Rate Risk Management

  • • Continue conservative mix of about 75% fixed and 25% variable exposure for next 2 – 3 years
  • •More toward 60/40 fixed/variable exposure over following 5 years
  • •Match currencies with underlying cash flow generation

Debt Portfolio

  • •Transition to single tier
  • •Reduce reliance on banks
  • • Increase flexibility by reducing covenants and other documentation constraints
  • •Lengthen average maturity
  • •Transition from secured to unsecured debt
  • •Target committed and unutilized facilities at 10 – 15% of debt portfolio

1. Historical Highlights

2. Financial Targets

3. Key Non-Operating Initiatives

4. Summary

Summary

  • • Strategic and financial position significantly and sustainably strengthened in last years
  • •Significant growth opportunities exist medium to long-term
  • • Our strategy has positioned us to benefit the most from industry growth
  • • We will continue to build on our very solid financial position and provide significant additional value to shareholders in the foreseeable future
  • • Target: average annual growth of revenues of 7-9% and low to midteen annual growth of net income

Summary

Leadership • Maintain our global leadership position
• Continue to shape the future of the dialysis
industry
Quality • Maintain superior quality in products and
services
Growth • Accelerate de novo developments
• Focus on organic revenue and per treatment
growth
• Expand renal drug therapy initiative
Financial • Control cost and spending
• Continue to de-leverage
• Continue profitable growth momentum
• Revenue to $> $11.5$ bn by 2010
• Earnings After Tax $-$ low to mid-teens

Safe Harbor Statement

This presentation includes certain forward-looking statements. Actual results could differ materially from those included in the forward-looking statements due to various risk factors and uncertainties, including changes in business, economic competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings and the availability of financing. These and other risks and uncertainties are detailed in the Company's reports filed with the Securities and Exchange Commission and the German Exchange Commission "Deutsche Börse".

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