425 1 a2135551z425.htm 425

Filed by Genzyme Corporation

(Commission File No. 000-14680)

Pursuant to Rule 425 under the

Securities Act of 1933

Subject Company: Ilex Oncology, Inc.

Commission File No. 000-22147

 

 

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1



 

May, 2004

 

The 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.

 

[GRAPHIC]

 

genzyme

 



 

Forward-Looking Statements

genzyme

 

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-TGFß 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 FormS-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.

 



 

Why Genzyme?

 

                  Leading positions in well-defined markets

 

                  A risk-balanced approach

•     diversified, global, vertical

 

                  Strong momentum in 2003, into 2004

•     expanded marketed product portfolio

 

                  Long-term growth drivers in place

•     advancing, multi-stage pipeline

 

[GRAPHIC]

 



 

Agenda

 

                  Company Overview

 

                  Multi-Stage Growth Plan

                  ILEX merger

                  Genzyme marketed products

 

                  Strategy and Outlook

 

[GRAPHIC]

 



 

Our Focus Remains Consistent

 

We seek frontiers

 

 

 

 

 

[GRAPHIC]

 

 

 

 

 

      Serious diseases

 

 

      unmet needs

 

[GRAPHIC]

 

 

      Patient-focused

+

 

      Standard of care products

 

 

      Technologically neutral

We develop and deliver
breakthrough therapies and services

 

      Sustainably creating shareholder value

 

 

 

[GRAPHIC]

 

 

 

 

 

      Significant improvement to patients’ lives

 

 

 



 

Therapeutic Areas

 

LSDs

 

Renal

 

Orthopaedics

 

Transplant &
Immune Disease

 

Oncology/
Endocrinology

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

[GRAPHIC]

 

 

 

 

 

 

 

 

 

 

 

*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 - TGFß antibodies

 

 

 

 

 

 

 

 

 

MS- small molecule

 

 

 

 

 

 

 

 

 

THP Collaboration

 

 

 

 

*Marketed Products

 



 

WW Reported Revenues:  Q1 2004 / YE 2003

 

 

 

Q1

 

Full Year

 

In millions, unaudited

 

Q1’04

 

Q1’03

 

2003

 

2002

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Renal

 

$

83

 

$

59

 

$

282

 

$

157

 

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Therapeutics

 

255

 

189

 

865

 

675

 

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Transplant

 

36

 

 

44

 

 

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Biosurgery

 

48

 

 

119

 

 

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Diagnostics/
Genetics

 

52

 

47

 

191

 

173

 

 

 

 

 

 

 

 

 

 

 

 

[GRAPHIC]

Other

 

16

 

16

 

79

 

62

 

 

 

 

 

 

 

 

 

 

 

 

 

Total Revenues

 

$

491

 

$

314

 

$

1,574

 

$

1,080

 

 

Notes: SangStat/Transplant revenues begin on 9/11/03.  Until 7/1/03, Biosurgery revenues were recorded separately.  Therapeutics revenues exclude Aldurazyme revenues recorded by the JV of $6.7M in Q4’03 and $11.5M for total 2003.

 



 

Genzyme Corporation 2004 Guidance

(February 19, 2004 guidance does not include impact of ILEX/IMPATH acquisitions)

 

DESCRIPTION

 

Ranges

 

Low

 

High

 

 

 

 

 

 

 

 

 

Cerezyme

 

 

 

$

770

 

$

790

 

 

 

 

 

 

 

 

 

Fabrazyme

 

 

 

170

 

185

 

 

 

 

 

 

 

 

 

Thyrogen

 

 

 

48

 

52

 

 

 

 

 

 

 

 

 

Other

 

 

 

2

 

3

 

 

 

 

 

 

 

 

 

Total Therapeutics

 

 

 

990

 

1,030

 

 

 

 

 

 

 

 

 

Renal

 

 

 

325

 

345

 

 

 

 

 

 

 

 

 

Thymoglobulin

 

 

 

90

 

100

 

 

 

 

 

 

 

 

 

Other Products

 

 

 

40

 

45

 

 

 

 

 

 

 

 

 

Total Transplant

 

 

 

130

 

145

 

 

 

 

 

 

 

 

 

Synvisc

 

 

 

110

 

115

 

 

 

 

 

 

 

 

 

Sepra

 

 

 

58

 

62

 

 

 

 

 

 

 

 

 

Other Biosurgery

 

 

 

45

 

48

 

 

 

 

 

 

 

 

 

Total Biosurgery

 

 

 

215

 

225

 

 

 

 

 

 

 

 

 

Diagnostic Products

 

 

 

90

 

95

 

 

 

 

 

 

 

 

 

Genetic Testing

 

 

 

110

 

120

 

 

 

 

 

 

 

 

 

Total Diag/Genetics

 

 

 

200

 

215

 

 

 

 

 

 

 

 

 

Total Other

 

 

 

65

 

70

 

 

 

 

 

 

 

 

 

TOTAL REVENUE (1)

 

 

 

$

1,930

 

$

2,030

 

 

 

 

 

 

 

 

 

GROSS MARGIN

 

 

 

76

%

77

%

 

 

 

 

 

 

 

 

SG&A

 

 

 

(565

)

(575

)

 

 

 

 

 

 

 

 

R&D

 

 

 

(385

)

(395

)

 

 

 

 

 

 

 

 

AMORTIZATION

 

 

 

(103

)

(103

)

 

 

 

 

 

 

 

 

NET INTEREST

 

 

 

(1

)

1

 

 

 

 

 

 

 

 

 

NET OTHER

 

 

 

(14

)

(15

)

 

 

 

 

 

 

 

 

TAX RATE

 

 

 

29

%

31

%

 

 

 

 

 

 

 

 

2004 GAAP EPS

 

 

 

$

1.37

 

$

1.47

 

 

 

 

 

 

 

 

 

2004 AMORTIZATION

 

 

 

$

0.28

 

$

0.28

 

 

 

 

 

 

 

 

 

2004 NON-GAAP EPS (2)

 

 

 

$

1.65

 

$

1.75

 

 

 

 

 

 

 

 

 

WTD AVG SHARES O/S

 

 

 

230

 

230

 

 

 

 

 

 

 

 

 

CAPITAL EXPENDITURES

 

 

 

$

180

 

$

200

 

 

Notes:

 


(1) Total revenues do not include estimated 2004 Aldurazyme revenues of $40 - $44M.

(2) Estimated 2004 non-GAAP EPS is calculated by adding back $0.28 of amortization to 2004 estimated GAAP EPS

 



 

Agenda

 

                  Company Overview

 

                  Multi-Stage Growth Plan

                  ILEX merger

                  Genzyme marketed products

 

                  Strategy and Outlook

 

[GRAPHIC]

 



 

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) Excludes Aldurazyme revenues of $11.5M in 2003, which were recorded by the Aldurazyme JV.

 



 

ILEX Oncology Profile

 

                  Focus on development of oncology drugs

                  Strong franchise with growing product (CAMPATH®)

                  Promising pipeline with two late-stage products

                  First class clinical development organization

                  Strong scientific resources

 

                  Locations in Texas, Massachusetts, Switzerland, England

 

                  2003 GAAP revenues of approximately $35M

 

                  2003 YE cash and equivalents of approximately $198M

 

                  2003 YE debt of approximately $40M

 



 

Transaction Overview

 

                  Stock for stock transaction

                  $26.00/share, collar of $59.88 (0.4342) to $46.58 (0.5582)

                  ILEX approximately 39M shares outstanding

                  Exchange ratio fixed at time of closing

 

                  Expected EPS impact to Genzyme

                  Excluding amortization, modestly dilutive in near-term

                  Accretive by 2006

 

                  Subject to Hart-Scott-Rodino Act and ILEX shareholder approval

 

                  Expected to close mid-2004

 



 

ILEX Pipeline

 

[CHART]

 



 

Genzyme Oncology

Combined with ILEX

 

Discovery

 

Preclinical Research

 

Early Development

 

Mid-Stage Development

 

 

 

 

 

 

 

                  TAPs

 

                  TEM Ab

 

                  Fusion Vaccine

 

                  ILX651

                  PRL3

 

                  Polyamines

 

                  DENSPM

 

 

                  TEM Sm

 

 

 

                  TGF-β Ab

 

 

 

 

 

 

 

 

 

Pivotal Development

 

Regulatory/ Reimbursement

 

Manufacturing

 

Sales and Marketing

                  Clofarabine

 

                  2 NDAs

 

                  Campath in 2007

 

                  12 MSLs

 

 

 

 

 

 

 

Existing Genzyme programs

 

ILEX programs/products

 



 

Genzyme Acquisition of IMPATH

Cancer Testing Business

 

                  $215 million cash purchase of Physician Services and Analytical Services business unit

 

                  Acquisition complete May, 2004

 

                  IMPATH

                  Leader in oncology testing area

                  Sites in Los Angeles (270 employees), Phoenix (95 employees) and New York (425 employees)

 

                  IMPATH Physician Services business unit

 

                  Combined with Genzyme Genetics enhances presence in oncology testing

                  Provides patient-specific cancer information to approx. 8,300 physicians in over 2,000 hospitals and oncology practices

 



 

Agenda

 

                  Company Overview

 

                  Multi-Stage Growth Plan

                  ILEX merger

                  Genzyme marketed products

 

                  Strategy and Outlook

 

[GRAPHIC]

 



 

Cerezyme® (imiglucerase) for Gaucher Disease

Our Flagship Product

 

[GRAPHIC]

 

                  Maintaining strong market position

                  Ongoing product enhancements

                  EU label expanded

                  Enhancing patient services

                  Committed to worldwide availability

 

WW Revenues ($M)

 

[CHART]

 



 

Fabrazyme® (agalsidase beta) for Fabry Disease

An Important Growth Driver

 

[GRAPHIC]

 

                  Developing global market

 

                  Strong international performance

                  Rapid growth continues

                  31 countries

                  Japan launch H1’04

 

                  U.S. launch progressing well

                  Broad label, co-selling with Renal team

 

                  Clinical database growing

                  Phase 4 data H2’04 (E)

 

WW Revenues ($M)

 

[CHART]

 



 

Aldurazyme® (laronidase) for MPS 1

Addressing an Urgent Need

 

[GRAPHIC]

 

                  Approved in U.S. and EU in April and June, 2003

      broad label indication

•     solid start to both launches

                  ~220 patients on therapy WW
(~65% are commercial)

 

                  Clinical base developing

                  global market development

                  children <5 yrs - data YE’04 (E)

                  care protocols evolving
(severity, combo BMT potential)

 

WW Revenues ($M)

 

[CHART]

 

JV revenues are reported in the “equity in unconsolidated affiliates” line

 



 

Thyrogen® (thyrotropin alfa for injection)

Expanding Indications

 

[GRAPHIC]

 

                  Marketed in U.S. since 1997

      new standard of care for thyroid cancer testing

      consistent growth

 

                  Future growth

      expanded indications include goiter and ablation

      clinical trials ongoing in both indications

      trial data available in 2004

 

WW Revenues ($M)

 

[CHART]

 



 

Renagel® (sevelamer hydrochloride)

A Long-term Growth Driver

 

[GRAPHIC]

 

More than just a phosphate binder

 

                  Solid global revenue growth

 

                  Increasing medical recognition

•     key part of ESRD treatment

•     unique lipid lowering effect

 

                  National Kidney Foundation new guidelines (K/DOQI)

•     first-line therapy

•     limit use of calcium, benefiting non-calcium based binders

•     positive Medicare impact expected

 

WW Revenues ($M)

 

[CHART]

 

Note:  Includes Chugai bulk supply/royalties.  1999 and 2000 include revenues recorded by Renagel JV of $19.5M and $8.0M, respectively.

 



 

Renagel®

Global Growth Opportunity

 

WW Kidney Dialysis Patients:  ~1.2 M

 

United States

 

Europe

 

Rest of World

~ 320,000 patients

 

~ 250,000 patients

 

~ 630,000 patients

 

 

 

 

 

[CHART]

 

[CHART]

 

[CHART]

 

 

 

 

 

~$181

 

~$76

 

~$24

 

 

2003 Revenue ($M)

 

 

 

Note:  Includes Chugai bulk supply and royalties

 

Source:  Fresenius Annual Report and Genzyme estimates

 



 

Synvisc® (hylan G-F 20)

Growing the Franchise

 

[GRAPHIC]

 

                  Vertically integrated technology platform (HA)

 

                  Early stage US/EU markets

 

                  Expanding indications

 

                  Next generation under development

 

WW Revenues ($M) from Synvisc®

 

[CHART]

 



 

Thymoglobulin® (Anti-thymocyte Globulin (Rabbit))

A Product Leader in Transplant

 

[GRAPHIC]

 

                  Standard of care in acute renal transplant rejection

•     investigating use in induction, BMT

 

                  Future growth

•     increased marketing efforts ex-U.S.

•     exploit broad E.U. label

•     expand U.S. use for induction, BMT

 

WW Revenues ($M)*

 

[CHART]

 


*Thymoglobulin/Lymphoglobulin; Genzyme recorded revenues beginning  9/11/03.  Prior to this, revenues were recorded by SangStat.

 



 

Next Wave of Growth Drivers

 

                  82 clinical studies currently ongoing

      25 in Phase 1 or 1 / 2

      17 in Phase 2 or 2 / 3

      7 in Phase 3

      25 in Phase 4 (postmarketing)

      8 in Registry/Survey Protocol

 

[CHART]

 

Advancing pipeline

 

      Myozyme®

      Anti-TGFß antibodies

      Tolevamer

      DX-88

      Thyrogen® – goiter

      Thyrogen® - ablation

      RDP-58

      Niemann-Pick

      MS – small molecule

      Oral iron chelator

      Cardiac cell and gene Tx

      LSD - small molecule

      Renagel®-CKD

      Mucositis

      TGF- β - other

      Cerezyme® II

      LSD-gene therapy

      Cancer programs

      DENSPM

 

2005 and Beyond

 



 

In the Clinic

 

The Unmet Need:  Pompe Disease

 

      Severe muscle degeneration

•     5,000 to 10,000 estimated patients worldwide

•     no available treatment

 

Status

 

      Largest R&D initiative

 

      Fast-track regulatory strategy

 

      Past trials yielded encouraging results

 

      Two new studies initiated in 2003

 

      Primary end point – survival

 

      Goal: regulatory filings in EU H2’04, U.S. H1’05

 

Myozyme®

(Alglucosidase alfa)

 

[GRAPHIC]

 



 

The Unmet Need:  Hereditary Angioedema

 

      Hereditary condition causing severe swelling, primarily of hands, feet, face, abdomen and larynx

•     13,000 to 66,000 estimated in U.S./EU alone

•     current U.S. treatment is anabolic steroids

 

Status

 

      JV with Dyax Corporation

 

      Early trials yield encouraging results

 

      Phase 2 (EDEMA1) study ongoing

•     EDEMA1 data due H1 2004

•     follow-on (EDEMA2) repeat dosing

•     may be used as pivotal trials

 

DX-88

 

[GRAPHIC]

 



 

Agenda

 

      Company Overview

 

      Multi-Stage Growth Plan

      ILEX merger

      Genzyme marketed products

 

      Strategy and Outlook

 

[GRAPHIC]

 



 

2004 – Continuing to Execute

 

      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-TGFß antibodies, DX-88, Tolevamer, MS-small molecule

 

      Leverage infrastructure

•     manufacturing efficiencies yield margin improvements

      existing Japanese infrastructure assists in new product launches

•     new revenue contribution from geographical expansion of Thymoglobulin®, Synvisc®

 

[GRAPHIC]

 



 

Why Genzyme?

 

      Leading positions in well-defined markets

 

      A risk-balanced approach

•     diversified, global, vertical

 

      Long-term growth drivers in place

      pipeline advancing to plan

 

      Strong momentum into 2004

      building on 2003 achievements

      2/16/04 ‘04 revenue guidance:

                        $1.9B – $2.0B

      2/16/04 ‘04 (E) EPS guidance:

                        GAAP $1.37 - $1.47

                        NON-GAAP $1.65-$1.75 (ex. amort. $0.28)

 

[GRAPHIC]

 



 

May, 2004

 

[GRAPHIC]

 

genzyme