425 1 a2137511z425.htm 425

 

Filed by Genzyme Corporation
(Commission File No. 000-14680)
Pursuant to Rule 425 under
the securities Act of 1933
Subject to Company: Ilex Oncology, Inc.
Commission File No. 000-22147

 

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Genzyme Stockholder’s Meeting
May 27, 2004

 

[GRAPHIC]

 

Elliott Hillback
Senior Vice President, Corporate Affairs

 


 


 

Forward-Looking Statements

 

[LOGO]

 

 

Annual Stockholder’s Meeting

 

These presentations contain forward-looking statements, including without limitation statements regarding:

                                          the potential business combination between Genzyme and ILEX, including expected timing, benefits and EPS impact;

                                          2004 financial guidance;

                                          projected plans and timing for product development and regulatory filing and action;

                                          product safety and efficacy, and the projected expansion of products to new indications;

                                          market estimates, including growth projections;

                                          product launch and marketing plans; and

                                          the expected drivers of future growth for product sales, our expected future revenues, revenue growth rates, end-user demand, and market penetration.

 

These statements are subject to risks and uncertainties, and our actual results may differ materially from those projected in the forward looking statements.  Those risks and uncertainties include:

                                          the ability to successfully complete the proposed business combination, including receipt of Hart-Scott-Rodino Act clearance and ILEX stockholder approval, and to successfully integrate ILEX’s business;

                                          actual financial results;

                                          the ability to successfully complete preclinical and clinical development of products and services, including Myozyme, DX-88, Tovelamer, and anti-TGFβ antibodies;

                                          the content and timing of submissions to and decisions made by the FDA and other regulatory agencies, including in regards to Myozyme, Thyrogen and Synvisc;

                                          the ability to obtain marketing and reimbursement approvals for, and to launch and to increase the use and sale of, products;

                                          the ability to advance product development pipelines, to leverage our current manufacturing and sales infrastructure and to expand the geographical reach of products, including Fabrazyme, Synvisc and Thymoglobulin;

                                          the ability to expand the labeled indications for products, including Thyrogen, Synvisc and Thymoglobulin;

                                          the accuracy of our estimates of the size and characteristics of the markets to be addressed by products and services, including growth projections;

                                          the accuracy of our information regarding the products and resources of our competitors;

                                          the ability to manufacture sufficient amounts of products for development and commercialization activities, and to manage product inventories;

                                          the scope of third-party reimbursement coverage for products and services;

                                          the ability to obtain, maintain and successfully enforce adequate patent and other proprietary rights protection of products and services;

                                          the scope, validity and enforceability of patents and other proprietary rights held by third parties and their impact on our ability to commercialize products and services;

                                          the success of existing sales forces and the ability to successfully expand sales and marketing teams in existing and new markets;

                                          the ability to establish and maintain strategic license, collaboration and distribution arrangements; and

                                          the risks and uncertainties described in reports filed under the Securities Exchange Act of 1934, including under the heading “Factors Affecting Future Operating Results” in Genzyme’s Registration Statement on Form S-4 filed April 5,2004.

 

Investors are urged not to place undue reliance on forward looking statements.  These statements are made as of today’s date and we undertake no obligation to update them.

 



 

On April 5, 2004, Genzyme filed with the U.S. Securities and Exchange Commission a registration statement on Form S-4 relating to the merger.  This presentation is not a substitute for the prospectus/proxy statement, a preliminary form of which is included in the registration statement.  Investors are urged to read the final version of that document, when it becomes available, because it contains important information about Genzyme, ILEX, the proposed business combination and related matters, including detailed risk factors.  The final prospectus/proxy statement and other documents filed by Genzyme and ILEX with the SEC will be available free of charge at the SEC’s website (www.sec.gov) and from Genzyme or ILEX.  Requests for copies of Genzyme’s SEC filings should be directed to 500 Kendall Street, Cambridge, Massachusetts 02142, Attention: Investor Relations. Requests for copies of ILEX’s SEC filings should be directed to Ilex Oncology, Inc., 4545 Horizon Hill Blvd., San Antonio, Texas 78229,

 

ILEX, its directors, and certain of its executive officers and employees may be deemed to be participants in the solicitation of proxies from the stockholders of ILEX in favor of the transaction. Information about the directors, executive officers and certain employees of ILEX and their direct and indirect interests is set forth in the preliminary prospectus/proxy statement and may be supplemented or modified in the final prospectus/proxy statement.

 

This presentation includes certain non-GAAP financial measures that involve adjustments to GAAP figures. Genzyme believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Genzyme’s past financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing both management and investors with a more complete understanding of underlying operational results and trends. In addition, these non-GAAP financial measures are among the primary indicators Genzyme management uses for planning and forecasting purposes. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures.

 


 


 

Genzyme Stockholder’s Meeting

 

[GRAPHIC]

 

 

Henri A. Termeer

 

 

President and CEO

 

 

 

 

 

May 27, 2004

 

 


 


 

Our Focus Remains Consistent:

 

[LOGO]

Patients and Performance

 

Annual Stockholder’s Meeting

 

 

We seek frontiers

 

 

 

 

 

 

 

 

 

[GRAPHIC]

 

 

 

[GRAPHIC]

 

 

 

 

 

•     Serious diseases

 

 

 

•     Patient-centric

•     unmet needs

 

[GRAPHIC]

 

•     Standard of care products

 

 

 

 

•     Technology neutral

We develop and deliver breakthrough therapies and services

 

 

 

•     Opportunistic

 

 

 

 

                  Naturally creates a diversified company

[GRAPHIC]

 

 

 

 

 

 

 

 

 

•     Significant improvement to patients’ lives

 

 

 

 

 



 

Areas of Focus

 

LSDs

 

Renal

 

Orthopaedics

 

Transplant &
Immune Disease

 

Oncology/
Endocrinology

 

 

 

 

 

 

 

 

 

[PHOTO]

 

[PHOTO]

 

[PHOTO]

 

[PHOTO]

 

[PHOTO]

 

 

 

 

 

 

 

 

 

Cerezyme®

 

Renagel®

 

Synvisc®

 

Thymoglobulin®/

 

Thyrogen®

Fabrazyme®

 

Sevelamer-CKD

 

Carticel®

 

Lymphoglobulin®

 

Cancer programs

Aldurazyme®

 

Renal fibrosis

 

Synvisc II

 

RDP-58

 

 

Myozyme®

 

PKD

 

 

 

DX-88

 

 

Niemann Pick

 

 

 

 

 

Anti-TGFβ antibodies

 

 

 

 

 

 

Diagnostics

 

MS-29155

 

 

 

 

 

 

 

 

THP Collaboration

 

 

 

 

 

 

Products

 

 

 

 

 

 

 

 

Services

 

 

 

 

 

Marketed Products

Products in development

 



 

Executing Multi-Stage Growth Plan

 

[CHART]

 


Notes: (1) Excludes Renagel revenues of $19.5M in 1999 and $8.0M in 2000, which were reported by the Renagel JV.

(2) GABI is included in “All Other”, not as a part of Biosurgery.

(3) Excludes Aldurazyme revenues, which were recorded by the JV with BioMarin Pharmaceutical, Inc.

 



 

Genzyme Stockholder’s Meeting
May 27, 2004

 

[GRAPHIC]

 

Mike Wyzga
Executive Vice President Finance, CFO

 

Financial Review

 



 

2003 Financial Summary

 

[LOGO]

Events & Milestones

 

Annual Stockholder’s Meeting

 

                  Shipments of Renagel produced in Ireland and UK plants

                  FDA granted marketing approval for Fabrazyme® and Aldurazyme® in the U.S.

                  Tracking stock structure eliminated

                  Aldurazyme® approved for marketing in the European Union

                  Acquired SangStat Medical Corporation

                  Paid down our $300M revolving line of credit

                  Sale of $690M convertible senior notes at 1.25%

 



 

                  Revenue grew 29%

                  Gross profit grew 30%

                  Gross margin increased to 72%

                  GENZ GAAP EPS of $.42

                  One time items and amortization of $353M

                  GENZ EPS of $1.39, excluding one time items and amortization

 



 

2003 Financial Summary

Revenue

 

Revenue increased to $1,714M

 

                  29% over 2002

                  Cerezyme increased 19% to $739M

                  Renagel increased 80% to $282M

                  Synvisc increased 23% to $110M

                  Fabrazyme doubled to $81M

                  Sepra increased 22% to $48M

                  Thyrogen increased 54% to $43M

                  Thymoglobulin increased to $28M

 

[CHART]

 



 

2003 Financial Summary

Gross Profit

 

Gross profit increased 30% to $1,219M in FY’03

 

                  Impact of Haverhill and Waterford coming online

                  Volume-related efficiencies

 

[CHART]

 



 

2003 Financial Summary

R&D Expense

 

R&D expense increased to $335M in 2003 from $308M in 2002

 

                  R&D expense as a percentage of revenue was 20%

                  Fabrazyme post marketing studies

                  Pompe clinical trials

                  Niemann-Pick B clinical spending

                  TGF β/CAT program

                  Renagel (DCOR study)

                  Acquisition of SangStat

 

[CHART]

 



 

2003 Financial Summary

Consolidated GAAP PBT

 

Consolidated GAAP profit before tax was $5M in FY’03

 

GAAP profit before tax lower in 2003 due to:

 

                  SangStat acquisition-related expenses

                  Loss on sale of CV Devices

                  Ortho goodwill impairment

 

[CHART]

 



 

2003 Financial Summary

Consolidated PBT (ex-amortization, FIN 46 and 1x events)

 

Consolidated profit before tax increased 75% to $421M in FY’03

 

[CHART]

 

One-time events include the following:

(1)       $353M in 2003 related to goodwill impairment (FAS142), purchase accounting (IPR&D), and loss on CV disposal

(2)       $164M in 2002 related to goodwill impairment (FAS142), business restructuring, and investment losses

(3)       $226M in 2001 related to purchase accounting (IPR&D, deferred comp, inventory step-up, etc.)

(4)       $177M in 2000 related to purchase accounting (IPR&D and investment gains)

 



 

2003 Financial Summary

Genzyme Corporation Cash and Investments

 

Cash increased to $1,227M from $1,195M in 2002

 

                  Significant sources of cash were:

                  $673M Convertible Notes

                  $388M in cash from operations

                  $116M in additional paid-in capital

 

                  Significant uses of cash were:

                  $537M for SangStat (net)

                  $260M in capital expenditures

                  $300M pay down of revolving debt

 

[CHART]

 



 

2003 Financial Summary

Capital Expenditures

 

Capital Expenditures Were $260M in 2003

 

                  Major projects were:

                  Waterford – Phase II Fill/Finish

                  Geel – MAB Phase I

                  Cambridge – Genzyme Center

                  Allston – 2nd Bioreactor Suite

 

[CHART]

 



 

2004 Guidance

 

•     Revenue

 

$1.9B - $2.0B

 

•     Gross margin

 

76% - 77%

 

•     R&D

 

$385M - $395M

 

 

 

(19% - 20% revenues)

 

•     Diluted EPS

 

$1.37 - $1.47

 

•     Amortization

 

$0.28 - $0.28

 

•     EPS excl. amortization

 

$1.65 - $1.75

 

 



 

Our Business Strategy

 

Expand franchise products

                        LSDs

                        Renagel®

 

Broaden use of commercial products

                        Thyrogen® – ablation, goiter

                        Synvisc® – hip, shoulder, ankle

                        Thymoglobulin® – induction, BMT

 

Advance our pipeline

                        Myozyme®, anti-TGFβ antibodies, DX-88, Tolevamer, MS-small molecule

 

Building oncology franchise

                        Acquiring Ilex Oncology

                        Acquired Impath cancer testing unit

 

Leverage infrastructure

                        Manufacturing efficiencies yield margin improvements

                        Existing Japanese infrastructure assists in new product launches

                        New revenue contribution from geographical expansion of Thymoglobulin®, Synvisc®

 



 

First Half, 2004

Events & Milestones

 

                  FTC closed review of Novazyme acquisition

                  Announced intent to establish a research facility in Europe

                  Received approval to market Fabrazyme® in Japan

                  Acquired Alfigen, Inc.

                  Initiated ankle trials for Synvisc in EU

                  Announced agreement to acquire ILEX

                  Acquired IMPATH cancer testing unit

 



 

Genzyme Stockholder’s Meeting
May 27, 2004

 

[GRAPHIC]

 

Georges Gemayel
Executive Vice President

 

Transplant

 



 

Sangstat Brand Portfolio

 

[LOGO]

 

 

Annual Stockholder’s Meeting

 

                  Thymoglobulin

                  Global brand

                  Acute immunosuppressant

                  SOT, BMT/Hematology, other

 

                  Lymphoglobulin

                  Multi-national brand

                  Acute immunosuppressant

                  BMT/Hematology, SOT

 

                  Cyclosporine

                  Gengraf U.S. branded generic, PSI Caps Europe

                  Chronic immunosuppressant

                  SOT, other

 

                  Celsior

                  Multi-national brand

                  Organ storage solution

                  SOT

 

                  RDP58

                  Phase 2 Clinical Development in Ulcerative Colitis

 



 

Genzyme Transplant Product Priorities

 

                  Invest

                  Thymoglobulin

                  Maximize penetration

                  Continuous Clinical Investigation (SOT, BMT)

                  Initiate Proof of Concept Clinical Studies

                  Markets Expansion

 

                  Maintain

                  Lymphoglobulin

                  Celsior

                  Gengraf (cyclosporine - US)

 

                  Partnering Opportunities

                  Outlicensing

                  PSI (cyclosporine - EU)

                  RDP58

                  In-Licensing

 



 

Integration Update

 

                  SangStat Offices

                  Fremont

                  Lyon

 

                  Sales

                  US

                  EU/International

 

                  Marketing and Medical Personnel

 

                  Operations

 

                  Legal Integration and Name Change

 

                  Finance/Sales Ops

                  US

                  EU/International

 

                  Distribution Agreements

 

                  Out-licensing of RDP58

 



 

[GRAPHIC]

 

Focus on Thymoglobulin

 



 

Thymoglobulin (TG)

 

[LOGO]

 

 

Annual Stockholder’s Meeting

 

Polyclonal Rabbit anti-thymocyte antibody

 

                  Produced by immunization of rabbits with human thymocytes

 

                  GMP manufacturing approved by US and European agencies

 

                  Registrations and labels

                  Registered in over 50 countries

                  Europe and ROW : Induction and treatment of rejection in SOT, severe aplastic anemia (SAA) and GvHD in most countries

                  US: Treatment of acute renal allograft rejection

 

                  Sales of Lymphoglobulin and Thymoglobulin are expected to reach between $90 to $100 million in 2004.

 



 

Regional Revenue Mix

 

[CHART]

 

Source: Genzyme Data

 



 

Thymoglobulin Regional Growth Rates Q1-03 to Q1-04

 

                  United States 19%

 

                  Europe 19%

 

                  Asia 23%

 

                  Americas 58%

 



 

Kidney Transplants Account for Approximately 70% of Total SOT

 

[CHART]

 

Worldwide Market:  71,989 SOT Procedures

Source: UNOS

 



 

Thymoglobulin Has Similar Potential in Europe and the U.S.

 

[CHART]

 

Total Market:  71,989 SOT Procedures

 

Source: UNOS, national registries and Genzyme surveys

 



 

The US Immunosuppresive Antibody Market is More Developed

 

[CHART]

 

Total:  $188 Million

 

Source: UNOS, National Registries and Genzyme Surveys

 



 

Thymoglobulin is the US Market Leader

 

[CHART]

 

Source: IMS Data

 



 

In the US Ab Induction Utilization is High, But it Differs by Organ

 

[CHART]

 

Source: UNOS

 



 

In Europe Ab Induction Utilization is Less Common Practice

 

[CHART]

 



 

[GRAPHIC]

 

Focus on RDP58

 



 

RDP58

 

[LOGO]

 

 

Annual Stockholder’s Meeting

 

                  Exclusive license to P&GP for GI and other diseases

                  P&GP is leader in treating GI disorders

                  Extensive Development and Commercialization expertise

 

                  Genzyme keeps rights for Pulmonary disorders and co-promotion rights in Oncology related disorders

 

                  Satisfactory financial terms

                  $10 Million in early payments

                  Additional milestone payments and royalties on product sales

 



 

Genzyme’s Transplant Business Summary

 

                  Integration of Sangstat has been completed

 

                  Efforts are focused on maximizing the potential of Thymoglobulin

 

                  On the outlook for opportunities to participate more broadly in the Transplant market

 



 

Genzyme Stockholder’s Meeting

 

[GRAPHIC]

 

Genzyme Genetics
Mara G. Aspinall

 

May 27, 2004

 



 

Genzyme Genetics

 

[LOGO]

Bringing our Mission to Life

 

Annual Stockholder’s Meeting

 

                  Genzyme Genetics leads the value-added diagnostic services market, providing our customers with:

                  Unequaled Quality

                  Superior Customer Service

                  Education and Interpretation

                  Meaningful Results for Physicians and their Patients

 

                  Genzyme Genetics current market areas:

                  Prenatal and Reproductive

                  Oncology and Pathology

 



 

Genzyme Genetics’ strategy

Build on Strengths for Continued Growth

 

Prenatal Esoteric Testing

 

[GRAPHIC]

 

DNA Testing

 

 

 

 

 

Leader in prenatal cytogenetics

 

 

 

Leader in Cystic Fibrosis and other carrier testing

 



 

Prenatal and Reproductive

Overview

 

Leading provider of genetic testing services

 

                  Over 500,000 tests annually

 

                  Leader in prenatal chromosome studies

 

 

 

Highest quality results, service and reporting

 

                  Largest national network of Board-certified Genetic Counselors

 

                  Proprietary online reporting system – Genzyme GOLD

 

                  24 hour, 7 day access to genetic experts

 

 

 

Active R&D program

 

                  Over 75 scientific publications and presentations per year

 

                  Focus on new markers and improving quality and cost effectiveness

 



 

Prenatal and Reproductive

Service Menu

 

                  Diagnostic Cytogenetic Analysis

                  Amniocentesis

                  Chorionic Villi Sampling (CVS)

                  Products of Conception

                  Adult Blood Samples

 

                  Fluorescence In-Situ Hybridization (FISH)

                  Insight® – Rapid Prenatal Diagnosis

                  Preimplantation Genetic Diagnosis (PGD)

 

                  Biochemical Risk Assessment

                  FirstScreen™ - Early risk assessment

                  Afp4® – Second trimester screen

                  IntegratedScreen™ – Highest detection rate

 

                  Carrier Screening via Molecular Diagnostics

                  Cystic Fibrosis

                  Diseases prevalent in Ashkenazi Jewish population

                  Fragile X

 



 

Prenatal and Reproductive

Leading Cystic Fibrosis Test

 

[CHART]

 

                  Innovator in CF Testing

                  Increased detection for a pan-ethnic population

 

[GRAPHIC]

 

Carrier Risks and Detection Rates by Ethnic Background

 

Ethnicity

 

Genzyme
Published
Detection
Rates

 

ACMG 25
Mutation
Detection
Rates

 

Caucasian

 

92.6

%

90

%

Ashkenazi
Jewish

 

97

%

97

%

African
American

 

81

%

69

%

Hispanic

 

72

%

57

%

 

                  Expanded mutation panel provides higher detection rates than the ACMG 25 panel

 



 

Oncology:

Next Step in Genzyme Genetics’ strategy

 

Prenatal Esoteric Testing

 

[GRAPHIC]

 

DNA Testing

 

[GRAPHIC]

 

Oncology

 

 

 

 

 

 

 

 

 

Leader in prenatal cytogenetics

 

 

 

Leader in Cystic Fibrosis and other carrier testing

 

 

 

Leader in cancer testing

 



 

Oncology

Value Added Testing Market Growth Factors

 

                  Targeted Therapeutics

                  Patient Specific Information Necessary

                  New Therapeutics require Companion Diagnostics

 

                  Advances in Diagnostic Science

                  Discovery of new diagnostics markers

                  Focus on early diagnosis

 

                  Shift towards Outpatient Diagnosis and Treatment

                  Need to monitor more closely

                  Greater use of reference labs

 

                  Demographics

                  Aging Population

                  Increased Incidence of Cancer

                  Increased Years of Survival

 



 

Oncology Acquisition

Why IMPATH?

 

                  IMPATH is the leader in oncology laboratory testing

                  Comprehensive test menu

                  Expert Staff Pathologists

                  Seasoned Laboratory Team

                  National oncology focused salesforce

 

                  Complementary strengths for continued growth

                  Focus on timely value-added results for physicians and their patients

                  IMPATH - The Cancer Information Company

                  Genzyme - “More than just a Test Result”

                  IMPATH brings full service oncology capabilities

                  Brand recognition

                  Extensive experience – more than 1 million cases

                  Genzyme brings strong and established infrastructure

                  Reimbursement – Billing and Collections

                  Operations

                  Research and Development

 



 

Genzyme and IMPATH

Alignment with Genzyme Corporation

 

                  Aligns Genetics with Genzyme’s overall corporate strategy

                  Focus on oncology

                  Area of unmet medical need

                  Leverages Corporate Science Research and Discovery

                  Full spectrum of oncology care from diagnostics to therapeutics

 

                  Building strategic links with Genzyme’s other therapeutic areas

                  Genetics is a critical resource and partner for LSD therapeutics

                  Leverage scientific and operational expertise for LSD diagnostics

                  Relationships with common key opinion leaders

                  Develop pharmacogenomics initiatives

                  Improve efficiency of clinical trials

                  Enhance medical impact for targeted patient population

 



 

Genzyme and IMPATH

Together

 

                  Leading Market Position

                  Leader in prenatal and reproductive testing

                  Leader in oncology/pathology testing

 

                  Comprehensive Testing Menus

                  15 complex technology platforms

 

                  Experienced Team of Employees

                  More than 1500 employees – with 75+ MDs, PhDs

                  Largest national network of genetic counselors

 

                  Broad Client Base

                  More than 17,000 physicians, 3,000 hospitals and 600,000 patients

                  Over 500 managed care contracts nationwide

 

                        Unmatched Infrastructure

                        Nationwide network of state-of-the-art facilities

                        Operational expertise

 



 

Genzyme and IMPATH

National Laboratory Network

 

Labs strategically placed throughout the country to:

 

                  Meet the needs of our regional customers

                  Take advantage of critical mass of expertise

                  Decrease turnaround times

                  Maximize efficiency

 

[GRAPHIC]

 



 

Worldwide Reach

 

[GRAPHIC]

 

Asia

 

                  Japan

                  Market leader in prenatal testing

                  Samples processed in US

                  Turn around time better than competition

                  Unique prenatal screening test in market

                  Lab reports in Japanese

 

[GRAPHIC]

 

Europe

 

                  Germany

                  Minority shareholder in genetics lab

                  Cytogenetics, FISH and molecular testing

                  Leveraging technology between US and EU

 

                  Active program to assess European testing market

                  Prenatal

                  Oncology

 



 

At the Core for the Future

Research and Development

 

                  Staying at the leading edge of technology

                  Reliability, accuracy, robustness

                  Cost-effectiveness

                  Increased information content

                  Multi technology approach

 

                  Increasing use of automation – inside and outside lab

                  Higher throughput

                  Increased accuracy

                  Lower cost

 

                  Continuing new test development

                  Better patient care

                  Increased clinical utility – evidence based medicine

                  Link to new therapeutics

 



 

Complex Value Added testing

has applications in all stages of life

 

Preconception

 

Prenatal

 

Neonatal

 

Pediatric

 

Adult

 

 

 

 

 

 

 

 

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

Screening ... Diagnosis ... Prognosis ... Therapeutic Selection ... Monitoring Prevention ... Predisposition

 



 

Genzyme Genetics

Continuing our Success

 

                  20 years of innovation and thought leadership

                  Industry-leading technologies and services

                  National access to standardized testing, education and genetic counseling services

                  Proprietary technologies, information and reporting systems

                  Evidence-based information and decision-support tools

                  Quality reporting to Payors and Providers

 

A commitment to empowering
physicians and their patients to achieve
a new standard of care.