"In Touch – Leading & Succeeding In Renal Therapy"
Raymond M. Hakim, M.D., PhD., Chief Medical Officer Sr. Executive Vice President Clinical & Scientific Affairs FMCNA
Capital Markets Day Luton, September 1–2, 2010
Doing Well by Doing Good
Improving Anemia Management & Outcomes
Optimization of Anemia Management
- 1. RightStart® at the initiation of dialysis
- 2. RightReturn® after Hospitalization
- 3. Catheter Reduction
- 4. Clinical research to reduce inflammation:
- a. Investigate the use of anti-inflammatory agents and ultrapure dialysate to improve Epogen responsiveness
- 5. Aim for an iron saturation (Tsat) of 30-50%
- 6. Computerized anemia management algorithm
- 7. Hemoglobin goal of 10.5 12.0 gm/dl (to avoid Hemoglobin <10 g/dl)
Optimization of Anemia Management
200% 250% 300% on Dose, % 80% 100% 120% B Group Average Epo Dose, % Patients, % Epo Dose vs. Hemoglobin (Q2 2010) 0% 50% 100% 150% <9.0 9-10 10-11 11-12 12-13 13-14 Average 3-Month Average Hemoglobin (g/dL) Average Epo Administration 0% 20% 40% 60% Percent of patients in HGB
Initiation Of Dialysis In The U.S.
- 57% had albumin concentration below lower limit of normal
- 50% had no visit with dietitian (21% had one visit)
- 80% of patients with Hgb<9 gm/dl were not receiving EPO
- 82% initiated dialysis with a catheter
- 18% had a permanent access 30 days before starting dialysis
- 53% used temporary access 60 days after initiation
Co-Morbidities and Risk Factors Associated with Early Mortality
Co-Morbidity
- Age
- Nutritional Status
- Diabetes
- Cardiovascular Disease
- LVH
Risk Factors
- Unplanned start (w/o permanent access)
- Short (<4 months) prior nephrological care
- Low residual renal output
Reversible Risk Factors
- High catheter rate
- Low albumin
- Anemia
- High Phosphorus
- Volume Overload
Mortality in Year One of Dialysis
Time from dialysis initiation (weeks)
Hospitalization in Year One of Dialysis
Time from dialysis initiation (weeks)
RightStart® Program
Hospital Days Per Patient Year at Risk
Survival of RightStart® Patients
One Year Survival of RightStart® Pts vs. Case-Control matching, All Pts n=approx 8,000
Advantages of the RightStart® Program
| Number of new (incident) patients in US |
100,000 |
| Number of new (incident) patients in FMS |
33,000 |
Current 1st Year Mortality (USRDS) |
25.4% |
Number incident pts at end of 1st year without RightStart® |
24,618 |
Expected 1st Year Mortality with RightStart® (HR = 0.75) |
19.0% |
Number incident pts at end of 1st year with RightStart® |
26,730 |
| Lives Saved/Lives Extended from RightStart® |
~ 2100 pts/Yr |
RightStart® Program Summary
Patients initiating dialysis present with several co-morbidities and risk factors, and knowledge deficits that are associated with a high initial 90-day mortality rate, (generally not reflected in published data).
Several of these risk factors can be attenuated or reversed more rapidly with an intensive team effort during the initial 90 days of therapy.
The RightStart® program, consisting of focused attention on reversible risk factors and patient education, resulted in a significant reduction in mortality and hospitalization during those initial 90 days, which extended up to 1 year following initiation of dialysis.
RightReturn® Program
Re-Hospitalization After Discharge from Hospital
| Medicare Fee-For-Service |
| (N=3 million) |
| Medical Discharges |
% Cumulative Re-Hospitalizations |
| 0-30 days |
21.1% |
| 30-60 days |
30.3% |
| 61-90 days |
36.6% |
| 91-180 days |
47.9% |
| 181-365 days |
59.4% |
Predictors of Re-Hospitalization
|
|
Relative Risk |
| Age |
<55 yr 55-69 yr 70-79 |
1.0 (ref) 0.99 1.07 |
| ESRD |
|
1.42 |
| No. of Re-Hospitalizations |
0 1 2 3 |
1.0 1.37 1.75 2.5 |
Pre- To Post-Hospitalization Outcomes
Medical Goals that are Synergistic with the "Bundle"
- 1. Reduce hospitalization and mortality in first 120 days
- 2. Optimize iron, Epogen management
- 3. Increase prevalence of home therapies
- 4. Reduce catheter rates, the main cause of BSI and Epogen "resistance"
Treatment Options Program (TOPs) Overview
- Initiated to educate patients with Stage 3 or 4 CKD prior to ESRD
- Consists of a two-hour education program provided at least every month in each FME "area"
- Patients are referred by their nephrologists or PCPs
- Non-biased presentation of available treatment modalities
- In center
- Home Therapy
- Transplant
- No therapy
- Patients are encouraged to attend with family members
- Advantages of Permanent Access are emphasized
Treatment Options September 2006 thru May 2010
- 35,521 pre-ESRD TOPS educations performed so far
- 132,930 patients admitted to FMS
- 11,579 of this group had TOPS education
- 121,351 starts did not have TOPS education
- Only 8.7% of total starts were TOPS educated
Follow up
• Goals
- Improve home therapy awareness
- Increased use of fistulas
- Decrease catheter utilization
- Early removal of catheters if necessary
- Follow up at 30, 90 and 180 days after TOPs education
- Remind patient to go back to referring physician
- Invite them and their families to return for another round of TOPs (prn)
Fistula/Grafts Start (Feb-May 2010)
23
HD Catheter Starts (Feb-May 2010)
Home Therapy Starts (Feb-May 2010)
Treatment Options Program (TOPs) Outcomes
Participation in TOPS leads to:
- Increased knowledge about Home Therapies and rate of home therapy selection
- Decrease use of hemodialysis catheters
- Greater use of AVF at start of dialysis
- Improved survival rate at 90 days after initiation of dialysis
Catheter Reduction Initiative
Catheter Maintenance Costs Per Patient
"Out of pocket" catheter related costs in the Bundle environment ~ \$ 10,000 per patient per year
Hydration Management
- Hydration management is essential to:
- Reduce hospitalization, ER visits, and "missed treatments.
- Increasing evidence that cardiovascular mortality (~50% of all deaths) is not "atherosclerotic" heart disease, but left ventricle failure.
Background and Medical Need
- The state of hydration depends on:
- Salt and water intake by patient (dietary counseling)
- Sodium "loading" during dialysis
- Sodium loading during dialysis is a major contributor to fluid overload
- increased thirst
- increased fluid intake
- Sources of sodium loading during HD:
- influx from dialysate (dialysate sodium higher than serum sodium)
- priming and rinsing of blood lines with saline
- treatment of hypotensive episodes and cramps with saline infusions
Na+ Distribution – 2008 Data
Na+ Gradient
70% of patients dialyze with dialysate sodium levels in excess of their serum Na+ levels
Projected Sodium Transfer from Dialysate to Serum
A constant Dialysate Na+ 5 mEq/L greater than Serum Na+ will result in very marked positive Na balance during dialysis
Hospital Admissions
Dialysate Sodium - Serum Sodium (mmol/L)
Economic Impact of Fluid Overload
Recent publication (CJASN, 2010) corroborated these estimates
Hospitalizations (-5 days) due to fluid overload in prevalent HD patients did cost Medicare / Medicaid a total of \$266 million (\$6,372 per episode) over a 2-year follow-up period in recent study
Blood Volume Monitor
- BVM tracks change of relative blood volume (RBV)
- If fluid removal exceeds plasma refilling RBV will drop 1
- A rapid drop of RBV may lead to systematic hypotension
- A biofeedback control prevents RBV to drop below individual threshold 2
Thank You!
Solving Today's Medical Needs In Renal Replacement Therapy: Bone Mineral Metabolism
Jose A Diaz-Buxo, MD, FACP Chief Medical and Regulatory Officer SVP Renal Products Group
Overview
- Bone and mineral metabolism (BMM) complications remain a major source of complications among patients with chronic kidney failure
- Despite significant advances in understanding the pathophysiology and treatment of these conditions achieved during the past 40 years, many problems remain to be solved
- The challenge we face in preventing and treating disorders of BMM is best appreciated by taking into account the many factors involved in its development
Chronic Kidney Disease - Factors Influencing Mineral and Bone Disorders
KDOQI Targets for BMM are not Achieved in Most HD Patients1,2
- 51-52 % of patients achieve the calcium target
- 47-49 % the phosphate
- 68-78 % the calcium-phosphate product
- 24-31% the PTH
- Only 2.4-6.9% of patients meet all 4 targets
- Clinical trials show that adjustment of dialysis prescription has great potential to achieve better control of the bone mineral metabolism. For example, dialysate calcium concentration, duration of the dialysis session and hemodiafiltration all have an impact on calcium, phosphate and PTH.
FMC Approach to Bone and Mineral Metabolism
- Use our extensive database to identify signals, trends, drugs and clinical practice effects on BMM
- Integrate clinical practices, dialysis prescription, nutrition and drugs into our therapeutic approach
- Construct theoretical models, test concept in pilot studies and validate them (Phosphorus Kinetic Modeling - PKM)
- Support development of drugs and devices to correct BMM abnormalities
Relative Risk of Mortality versus Phosphorus
o of death Data adjusted for case mix: age, gender, race, diabetes, body surface area, vintage and laboratory: albumin, hemoglobin, equilibrated urea Kt/V, phosphorus, WBC 1.5 2.0 Ref * * * * * * * * * Three-Month average phosphorus Hazard ratio o 0.0 0.5 1.0 *
Data source: Fresenius Data Warehouse Baseline period: Q4 2005; Follow-up period: 2006
Need for Improved Treatment Algorithm to Achieve Phosphate and Calcium Targets
Distribution of phosphate and calcium among patients receiving PhosLo® (n=31,712)
Data source: Fresenius Data Warehouse
Latest lab results between 3/1/2007 and 5/31/2007 among patients with open order for PhosLo® at that time 43
Introduction to Phosphorus Kinetic Modeling (PKM)
- Hyperphosphatemia in dialysis patients is a major cause of:
- Morbidity (Calcification, cardiovascular disease, bone disease)
- Mortality
- Calcium acetate effectively binds phosphorus in the gut to prevent absorption, but may increase calcium load
- Most dialysis patients are in positive calcium balance, regardless of phosphate binder
- Patient compliance with therapy is a strong determinant of phosphate and calcium balance
The Phosphorus Kinetic Model (PKM)
- Definition:
- A kinetic model identifying the interacting effects of vitamin D analogues, phosphate binders and dialysate Ca on P and Ca mass balance in hemodialysis
- Goal of PKM model:
- To help control a hemodialysis patient's serum P level through the use of Calcium Acetate and achieve K/DOQI guidelines for P and Ca without the need for additional blood draws and lab tests
- Optimize phosphate binder therapy and patient compliance
- Match Ca removal during dialysis to Ca accumulation between dialyses to prevent Ca overload or depletion
- Seamless integration between central lab (Spectra), clinic and PKM report
- FMC has completed a pilot study and is conducting a second clinical trial to validate the model
Serum Phosphorus and Calcium
Error bars represent 95% confidence interval, * p < 0.05, compared to month 0 # p < 0.01, compared to month 0
Calcium Phosphorus Product
# p < 0.01, compared to month 0
Physician Report
48
Patient Report
PKM 2 Study Rationale
- Validation of positive results from the pilot study
- The primary endpoint is the change in serum phosphorus between a baseline period and the latest value of the intervention period.
- Addressing the changing clinical/ business paradigm
- PKM algorithm is patient-centric
- Revised PKM algorithm helps manage multi-faceted BMM therapy
- -Efficient and effective calcium acetate binder therapy
- -Dialysate calcium concentration
- -Efficient Vitamin D use
- -Optimal use of Cinacalcet
- -PKM 2 support quality of care metrics/ initiatives (Bundle)
PKM Clinical Application
- Prescribe patient-specific parameters:
- Recommended dietary phosphorus intake
- Vitamin D dose
- Dialysate
- Phosphate binder dose
- Cinecalcet dose
- Assess patient compliance
- PKM will assist nephrologists in adjusting both phosphate binder dose, dialysis prescription and patient compliance to achieve desired phosphate and calcium values in support of BMM
PKM Conclusions
- Useful tool for helping chronically hyperphosphatemic patients meet phosphorus target without increasing serum calcium.
- PKM report provides valuable bone and mineral metabolism information to physicians and patients that can be used as formal prescription
- PKM provides cost effective optimization of BMM therapy
Thank You!
Dry Weight and Bone Mineral Metabolism Management in EMEALA
Wolfgang Wehmeyer Senior Vice President International Marketing & Medicine
Fresenius Medical Care Experience
OnlineHDF and Body Composition Monitor (BCM) and Bone Mineral Metabolism Management (BMM) are as important as eating and drinking.
An Affordable and User Friendly Product with Impressive Impact
Fluid Overload is as Serious as Diabetes
Fluid Overload is as Serious as Diabetes
The mortality risk of overhydration in haemodialysis patients. Wizemann V, Wabel P, Chamney P, Zaluska W, Moissl U, Rode C, Malecka-Masalska T, Marcelli D. Nephrol Dial Transplant. 2009 May;24(5):1574-9.
BCM
An Affordable and User Friendly Product with Impressive Impact
Fluid Overload is as Serious as Diabetes
50 - 60% of All PD Patients are "Out of Range" (30-40% in HD)
50-60% of All PD Patients are "Out of Range"
Overhydration [L]
Assessment of Fluid Status and Nutritional Status in European Peritoneal Dialysis Patients. Objective Measurement through Body Composition Monitoring
1 Van Biesen W, 2Covic A, 3Fan S, 4Claes K, 5Lichodziejewska-Niemierko M, 6Verger C,
7Steiger J, 8Wabel P, 8Gauly A, 8Schoder V, 8Himmele R
BCM
An Affordable and User Friendly Product with Impressive Impact
Fluid Overload is as Serious as Diabetes
50 - 60% of All PD Patients are "Out of Range" (30-40% in HD)
We Can Do Something About It
We Can Do Something About It
Guided optimization of fluid status in haemodialysis patients. Machek P, Jirka T, Moissl U, Chamney P, Wabel P. Nephrol Dial Transplant. 2010 Feb;25(2):538-44.
BCM Outstanding Clinical Documentation
More than 50 publications in the past 3 years
Achieving Benefits for Patients Requires a Change in Clinical Procedures
- Guiding Rules for NephroCare Centers
- Prescription Strategy of PD Solutions
- Scientific Marketing
Bone Mineral Metabolism FME Online HDF and Osvaren®
A Superior Treatment Proposition
Fresenius Medical Care HDF / Online HDF
Improved Phosphate Control over HF Dialysis
Penne et al. 2010 (CONTRAST study)
- Decreased pre-dialysis phosphate levels after 6 months of treatment with online HDF
- Phosphate treatment targets were satisfied more often, whereas the use of phosphatebinding agents was reduced.
- Increased phosphate removal using HDF potentially may improve clinical outcomes
Vaslaki et al. 2006
- Convective solute transport in oHDF improved the elimination of phosphate
- A constant lowering of serum phosphate levels was possible, which has been not described before to our knowledge
OsvaRen®
• A new combination drug for Hyper-phosphatemia
- Strong data from prospective, randomized trial (CALMAG)
- Effective Phosphate control, faster to target than Sevelamer
- Full Calcium Control through reduction of Ca++ component
- Addition of anti-calcification potential through benefit of Mg++
- Premium Priced over Calcium based binders
- Economically attractive through excellent value compared to Ca-free binders
Convincing Data
Serum Phosphorous Pills per patient per day Ionized Serum Calcium
Time course of serum phosphorus: Fast decline with Osvaren
Area under the curve (AUC, [=total exposure]) for serum phosphorus significantly lower with Osvaren
Study medication intake/day significantly lower at week 25 with Osvaren
No significant difference in ionised serum calcium between groups
Sufficient Serum Magnesium: Benefits
Serum Magnesium Is A Significant Predictor For Survival In Dialysis Patients
Lower serum magnesium levels are an independent factor of vascular calcification in patients with CKD
Study of 515 dialysis patients: Elevated magnesium levels are associated with improved survival
Ishimura 2007 Ishimura 2007 Lacsson 2009
27,544 dialysis patients (FMCNA): Elevated magnesium levels are associated with lower risk of mortality
Summary
Low
Thank You!
Hydration Management North American Strategies for Commercialization
Mark Costanzo, President Renal Therapies Group of FMCNA
Fluid Management Components Under Study At Fresenius Medical Care
Sodium (salt) management Alignment of serum and dialysate sodium
Determination of the target weight/dry weight Application of bioimpedance and plasma-refilling rate
Method to Correct Simplified Na+ Alignment Algorithm
- Calculate mean of patient-specific serum Na+ for the past four months (sNat:t-4)
- Calculate Na+ gradient (gNa) =
dialysate Na (dNa) - sNat:t-4
Hydration Management Flow Diagram
Dry Weight: A Problematic Measure, in Practice
- Dry Weight the weight below which patients develop intradialytic hypotension (IDH) on HD
- Hypotension may occur in overhydrated patients when ultra filtration exceeds plasma refilling rate
- Physicians prescribe a target weight (TW) based on clinical assessment of the patient
- Currently, there are no routine methods available to objectively assess DW
Current Dry Weight Methodologies Technology for Volume Management
Blood Volume Monitoring
Volume management with biofeedback biofeedback technology
Blood Temperature Monitoring Bioimpedance
Achieving target dry weight while maintaining maintaining cardiovascular stability
Determining target dry weight
* not 510k cleared
Global Strategy – Renal Pharma/Therapy – Hydration Management
2008T with CDX Access to Data is Essential for Hydration Management
- Fresenius Clinical Data Exchange™ (CDX) - provides access to clinic MIS system and dialysis treatment data on the 2008T platform
- Lab data and other key MIS content displayed on 2008T for comprehensive prescription decision making
- Online data from blood volume monitor/ bioimpedence measurements used for feedback control
- 2008T allows chair side documentation for adjustment of prescription
Anemia Management
Anemia Management
- Improving Anemia Management and Outcomes
- Impact of Bundle
- Narrowing the Distribution to 10 -12 g/dl
- Improving IV Iron Management
- Reduced Inflammation
Narrowing the Distribution to 10–12 g/dL with Recommended Epogen Dose (RED) Algorithms
- Spectra Lab Results:
- Weekly HGB values (up to 4 mo data)
- Monthly TSAT values (up to 4 mo data)
- Possibly latest ferritin value in past 4 mo (max value for IV iron)
- Optional other lab values relevant to hyporesponse, such as albumin, CRP, aluminum, etc.
- Clinical Data:
- Current Epogen prescription (dose and frequency)
- Current IV iron prescription (dose, frequency)
- Total IV iron administered in past 3 months prior to first run of algorithm. (Later, the HD machine or computer running the algorithm can accumulate this information.) 81
Diagram of HGB Extrapolation
Time (Weeks)
Fresenius Medical Care Implementation of Anemia Management Algorithm
83
Venofer - Iron Sucrose For Effective Iron Management
PharmaTech Venofer Pump Features/Benefits
- Ease of use Set dose and rate
- Accurate delivery Precise dose and rate delivery
- Reduces set-up time – eliminates syringe fill and labeling
- Cost effective delivery
PharmaTech Anemia Management Module Concept
Features/Benefits:
- Ability to tailor ESA and iron dosing to actual doses administered and optimized with the FMC algorithm.
- Doses entire deliverable volume of ESA from vial
- Documentation displayed for the dose administered
- Simplifies RN's task of measuring out exact ESA doses into the syringes
Water Purity: Does it Make a Difference in Reducing Inflammation?
- Bacteria, endotoxin and DNA fragments in the dialysate may pass into the blood with highly permeable dialysis membranes.
- Monocytes activated by bacteria-derived substances secrete a variety of pro-inflammatory cytokines (IL-1, IL-6 and TNF)
- This inflammatory state is associated with malnutrition, accelerated atherosclerosis and a reduced erythropoietin responsiveness
- Ultrapure dialysis fluid is associated with:
- improved nutritional status
- an increased responsiveness to administration of iron and erythropoietin
Ultrapure Dialysate
Corrective Measures
- Controlled ultrafiltration by placing Diasafe® Plus filters in the fluid path of standard HD machines
- Improve Water Quality
- Reduce bioburden
- Reduce dead space in centralized RO system
Diasafe® Plus Exceeding Proposed AAMI Standards
Dialysate Endotoxin Levels Using Diasafe Filters and Conventional Facility Water Treatment
Sands J. Stano M., Li Z., Bryant R., Ofsthun N., Updyke D., Lazarus J. (2004). Diasafe® decreases endotoxin Levels 16 fold below new AAMI standard. (Abstract submitted for ASN)
AAMI = Association for the Advancement of Medical Instrumentation
Global Strategy – Renal Pharma/Therapy – Anemia Management
2008T with CDX Access to Data is Essential for Anemia Management
- Fresenius Clinical Data Exchange™(CDX) provides access to clinic MIS system and dialysis treatment data on the 2008T platform
- Lab data and other key MIS content displayed on 2008T for comprehensive prescription decision making
- Online data from Venofer® or AMM module used for feedback control
- 2008T allows chair side documentation for adjustment of prescription
Bone Mineral Metabolism
Bone Mineral Metabolism
- Compelling Need
- Phosphate and Bone Mineral Management PharmaTech
- Pharmaceutical Delivery System FMCRx
Compelling Need to Improve Phosphate & Bone Mineral Management
Overall strong quality performance
|
North America |
|
|
|
EMEA |
| % of patients |
(USA) Q2 2009 |
Q2 2010 |
|
Q2 2009 |
Q2 2010 |
| Kt/V 1.2 |
96% |
96% |
|
95% |
95% |
| Hemoglobin = 10-12 g/dl |
64% |
68% |
|
54% |
54% |
| Albumin 3.5 g/dl |
82% |
81% |
|
88% |
86% |
| Phosphate 3.5-5.5 mg/dl |
52% |
55% |
|
61% |
61% |
| Hospitalization days |
10.1 |
* 9.9 |
|
8.5 |
9.2 |
* The hospitalization rates for the US reflects adoption of CMS policy
PharmaTech - Implementation of Phosphorus Kinetic Modeling
Phosphate Binder Portfolio
- PhosLo (calcium acetate gelcap)
- PhosLo authorized generic
- Phoslyra (liquid calcium acetate formulation)
- Clinical trials have proven safety and efficacy. Waiting for FDA to complete upstream reviews
- Aim is to enhance patient adherence and thus serum P management by reducing pill burden, reduce fluid ingestion and providing an alternative for patients with swallowing difficulties
- Interest in licensing of branded or non-calcium based P binder: PA-21
FMCRx
FMCRx is a renal - focused specialty pharmacy with pharmacists who are trained on the special needs and medications of CKD and ESRD patients
Benefits to FMCNA include:
- Medication management improves compliance to drug regimen
- Improved adherence leads to improved quality of life for patients
- Convenience, shipped to the patient's home
- Medication summary report of all drugs prescribed and filled sent to clinics each month
- Control costs under the bundle
Global Strategy – Renal Pharma/Therapy – Bone Mineral Management
Thank you!
"In Touch – Leading & Succeeding In Renal Therapy Worldwide"
Michael Brosnan, Chief Financial Officer
Capital Markets Day Luton, September 1–2, 2010
Agenda
} 1 HISTORICAL HIGHLIGHTS 1. Historical Highlights
} 2 FINANCIAL TARGETS 2. 2010 Financial Guidance
KEY NON-OPERATING INITIATIVES 3. Goal 13 – Strategic Financial Objectives
SUMMARY 4. Goal 13 – Strategic Financial Objectives - Capital Structure
5. Summary
Historical Highlights Topline Growth Drivers
Topline Growth Drivers Revenue
- Geographic Expansion
- Market Share Gains
- Revenue Per Treatment Increases
- Geographical Mix Management
- Successful Execution of Acquisitions and Integration Strategy
Historical Highlights Earnings Growth Drivers
Earnings Growth Drivers Net Income \$891 • Scale Effects • Revenue Per Treatment Increases attributable to FMC AG & Co. KGaA \$455 2005 2009 CAGR 18.3% • Manufacturing Performance • Product Mix • Clinic Cost Control • Favorable Financing Conditions • Slightly Lower Tax Rate
Historical Highlights - Balance Sheet And Cash Flow Growth Drivers
2005 2009
Historical Highlights - Our Credibility With The Capital Markets
|
Meeting Guidance and Investor Expectations |
|
|
|
|
|
2005 |
2006 |
2007 |
2008 |
2009 |
| Revenue |
|
|
|
|
|
Net Income attributable to FMC AG & Co. KGaA |
|
|
|
|
|
| Leverage |
|
|
|
|
|
| Investments |
|
|
|
|
|
| Operating Cash Flow |
|
|
|
|
|
Agenda
} 1 HISTORICAL HIGHLIGHTS 1. Historical Highlights
} 2 FINANCIAL TARGETS 2. 2010 Financial Guidance
KEY NON-OPERATING INITIATIVES 3. Goal 13 – Strategic Financial Objectives
SUMMARY 4. Goal 13 – Strategic Financial Objectives - Capital Structure
5. Summary
Financial Guidance Outlook 2010
Fully on Track for 2010 Targets
| US\$ millions |
Guidance |
| Net revenue |
> \$12,000 |
Net income attributable to FMC AG & Co. KGaA |
\$950 - 980 |
| Leverage ratio (Debt/EBITDA) |
< 2.5 |
Capital expenditures Acquisitions Updated |
~ \$550 - 650 up to \$500 |
Financial Guidance Goal 10 - Achievements
|
Goal 10 |
2010 - Guidance |
| Revenues |
> \$ 11.5 bn |
> \$12.0 bn |
thereof: Pharma Sales incl. internal sales |
\$ 400 million |
~ \$ 400 million |
| EBIT Margin |
~ 20 bps (incremental increases p.a.) |
~ 15.6 % |
| Interest Expense |
< 6.5% |
< 5.5% |
| Tax Rate |
< 38 % |
34.5% - 35.5 % |
Net Income / EPS attributable to FMC AG & Co. KGaA |
Low to mid-teen (growth p.a.) |
\$ 950 - \$ 980 million |
| Operating Cash Flow |
Maintain to slightly improve current level of 10% of Revenue |
> 10 % of Revenue |
| CapEx & Acquisitions |
~7 % of Revenue |
~9 % of Revenue |
Agenda
1. Historical Highlights
2. 2010 Financial Guidance
3. Goal 13 – Strategic Financial Objectives
4. Goal 13 – Strategic Financial Objectives - Capital Structure
5. Summary
Goal 2013 Strategic Financial Objectives Revenue Growth
(Average Annual, Constant Currency)
|
Global Growth |
Price/Mix Increase |
Market Share & Acquisitions |
Total |
| Services |
5 – 6% |
up to 2% |
1 – 2% |
6 – 9% |
| Products |
4 – 5% |
up to 1% |
1 – 2% |
5 – 7% |
Total Objective |
|
|
|
6 – 8% |
|
|
|
|
|
Goal 2013 Strategic Financial Objectives EBIT Margin
- Scale effects
- Cost control
- Strategic investment / placement
- US: Bundle / De novos / Payor mix
- International: Leveraging the existing organizational structure through expansions
- Manufacturing capacity / demand management and efficiencies
Goal 2013 Strategic Financial Objectives Net Interest Expense
- Amend & extend the existing Senior Credit Agreement by two years (Term Loan A and Revolving Facility)
- Issuance of Senior Bond early 2011 to refinance subordinated Trust Preferred Securities
- Issuance of Senior Bond to refinance Term Loan B of the Credit Agreement in mid 2012
Goal 2013 Strategic Financial Objectives Effective Tax rate
• Continue on a sustainable basis
Goal 2013 Strategic Financial Objectives Net Income / EPS
| Objective |
Current |
2013 Annual Growth |
Net Income attributable to FMC AG & Co. KGaA |
\$950 – 980 million |
High single to low double digits |
| EPS |
|
High single to low double digits |
Goal 2013 Strategic Financial Objectives Cash from Operations
- Improve profitability
- Continue with effective working capital management
- Strong collection process
- Maintain effective inventory management
Goal 2013 Financial Objectives – Capital Expenditures and Acquisitions
| Current |
2010 |
| Capex & Acquisitions |
Capex & Acquisitions |
| ~9% of Revenue |
~7% of Revenue |
- Take advantage of existing growth opportunities
- Prudent investment to avoid dilution of return on invested capital
Goal 2013 Strategic Financial Objectives
|
2010 - Guidance |
Goal 13 |
| Revenues |
> \$12bn |
6-8% Growth* |
| EBIT Margins |
~ 15.6% |
10 - 20 bps (incremental increases p.a.) |
| Interest Expense |
< 5.5% |
6.0 to 6.5% |
| Tax Rate |
34.5 – 35.5% |
35 – 36% |
Net Income attributable to FMC AG & Co. KGaA |
\$950 - 980 |
High single to low double digits |
| Operating Cash Flow |
> 10% of Revenue |
> 10% of Revenue |
| CapEx + Acquisitions |
~9% of Revenue |
~7% of Revenue |
Agenda
} 1 HISTORICAL HIGHLIGHTS 1. Historical Highlights
} 2 2. 2010 Financial Guidance
} 3
} 4 1183. Goal 13 – Strategic Financial Objectives 4. Goal 13 – Strategic Financial Objectives - Capital Structure
5. Summary
Goal 13 – Strategic Financial Objectives Capital Structure
- FME has current guidance Debt/EBITDA ratio of < 2.5x
- Strategically our franchise can operate effectively with ~ 2.5x leverage
- Equivalent to a credit rating of BB to BBB-
- Industry well suited to "reasonable" leverage
- Non-cyclical
- Predictable cash flow
- Attractive profitability
- Foreseeable investment needs
- This provides the flexibility to seek further investment opportunities and finance them with debt
Goal 13 – Strategic Financial Objectives Capital Structure
Debt Portfolio
- Amend & extend Senior Credit Agreement
- Transition to single tier
- Lengthen average maturity
- Target committed and unutilized facilities at \$300 500 million
Agenda
1. Historical Highlights
2. 2010 Financial Guidance
3. Goal 13 – Strategic Financial Objectives
4. Goal 13 – Strategic Financial Objectives - Capital Structure
5. Summary
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 |
• Benefit from product innovations • Take opportunity of international growth potential • Introduce new therapy offerings • Continue horizontal expansion of service and product range |
| Financial |
Control cost and spending • • Seek attractive investment opportunities • Continue profitable growth momentum • Revenue to grow 6-8% per annum, constant currency • Earnings After Tax – high single to low double digits |
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