425 1 a2030188z425.txt 425 Filed by Genzyme Corporation (Commission File No. 000-14680) pursuant to Rule 425 under the Securities Act of 1933 Subject Company: GelTex Pharmaceuticals, Inc. (Commission File No. 000-26872) This material is not a substitute for the prospectus/proxy statement Genzyme and GelTex will file with the Securities and Exchange Commission. Investors are urged to read that document because it will contain important information, including detailed risk factors. The proxy statement/prospectus and other documents filed by Genzyme and GelTex with the SEC will be available free of charge at the SEC's website (www.sec.gov) and from Genzyme or GelTex. This material contains forward-looking statements, including statements about the consummation and anticipated timing of the merger, the potential market opportunity for Renagel, the expected drivers of growth for the market opportunity, the anticipated impact of Renagel on Genzyme's future growth, the potential short and long-term revenues from Renagel, the expected benefits of the merger, the value of the merger consideration, the tax-free treatment of the receipt of Genzyme General common stock, the anticipated impact of the acquisition on Genzyme's earnings, cash-earnings-per-share, and development programs, Genzyme's plans concerning the operation of GelTex's business after the merger, estimates concerning the current and future dialysis patient population, the anticipated impact of Renagel on patient morbidity and mortality, the cost of care for patients, the anticipated benefits of the newly launched tablet formulation of Renagel, plans to announce trial data, plans to initiate clinical trials of Renagel, GT 160-246, and other product candidates, estimates concerning the C. DIFFICILE COLITIS patient population, and expectations concerning GelTex's product candidates and polymer technology platform. Actual results may materially differ due to numerous factors, including without limitation conditions in the financial markets relevant to the proposed merger, the receipt of regulatory and other approvals of the transaction, the operational integration associated with the transaction and other risks generally associated with such transactions, increasing market acceptance of Renagel, optimal dosing and patient compliance with respect to Renagel, market acceptance of Renagel tablets, the competitive environment for the dialysis market, the results of clinical trials, the efficacy and safety of products, enrollment rates for clinical trials, the content and timing of submissions to and decisions by regulatory authorities, the availability of reimbursement from third-party payers, the ability to manufacture sufficient quantities of product for development and commercialization activities, the accuracy of the companies' information about the dialysis and the C. DIFFICILE COLITIS patient populations and the market for Renagel, the accuracy of the companies' expectations about growth in the dialysis patient population, the ability of Genzyme to successfully commercialize products and the risks and uncertainties described in Genzyme and GelTex's reports filed with the Securities and Exchange Commission under the Securities Exchange Act of 1934, as Amended, including without limitation Exhibit 99.2 to Genzyme's Annual Report on Form 10-K for the year ended December 31, 1999, as Amended. GENZ stock is a series of common stock of Genzyme Corporation. Therefore, holders of GENZ stock are subject to the risks and uncertainties described in the aforementioned reports. [The following is the text of slides from a slide show being presented in meetings with analysts, potential investors and others.] [PHOTO] GENZYME GENERAL ACCELERATING MOMENTUM... FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements, including statements regarding our: - expectations concerning the proposed merger with GelTex Pharmaceuticals; - anticipated benefits of, and revenues from, Renagel-Registered Trademark- brand phosphate binders; - projected product development, regulatory, and commercialization time tables; - market estimates and sales and marketing plans; and - expected future revenues, earnings per share, growth rates, and cash flows. Actual results could materially differ due to numerous risks and uncertainties, including: - the receipt of regulatory and other approvals of the proposed merger; - increasing market acceptance of, and optimal dosing and patient compliance with respect to, Renagel-Registered Trademark-; - our ability to successfully complete development of and commercialize products; - our ability to manufacture sufficient amounts of products for development and commercialization activities; - our ability to obtain and maintain adequate proprietary rights protection of products; - the content and timing of decisions made by regulatory authorities; - the accuracy of our market estimates and information about the competitive environment; and - the risks and uncertainties described in Genzyme's and GelTex's reports filed with the SEC, including Exhibit 99.2 to Genzyme's 1999 annual report on Form 10-K, as amended. This material is not a substitute for the prospectus/proxy statement Genzyme and GelTex will file with the SEC. Investors are urged to read that document because it will contain important information, including detailed risk factors. The proxy statement/prospectus and other documents filed by Genzyme and GelTex with the SEC will be available free of charge at the SEC's website (www.sec.gov) and from Genzyme or GelTex. genzyme general GENZYME CORPORATION - DIVISIONS ----------------------------------------------------------------------------- GENZYME GENERAL GENZYME MOLECULAR (NASDAQ:GENZ) ONCOLOGY (NASDAQ: GZMO) ----------------------------------------------------------------------------- GENZYME TISSUE GENZYME SURGICAL REPAIR PRODUCTS (NASDAQ: GZTR) (NASDAQ:GZSP) ----------------------------------------------------------------------------- OUR STRATEGIC VISION - Focus on chronic debilitating diseases with well-defined patient populations - Develop and expand robust pipeline - Extend and leverage unique worldwide infrastructure - Manage the business genzyme general GELTEX PHARMACEUTICALS - Two patent-protected, marketed products - Renagel-Registered Trademark- brand phosphate binder - WelChol-TM- brand bile acid sequestrant - Exciting product pipeline - GT160-246 for CLOSTRIDIUM DIFFICILE infections - Fat absorption inhibitors for obesity - A number of early stage programs - Unique platform technology - Productive research/development team - Facilities, cash, NOLs genzyme general GELTEX PRODUCT PIPELINE
Research & Regulatory Development Phase 1 Phase 2 Phase 3 Review Marketed --------------------------------------------------------------------------------- Renagel(R) Capsules - U.S. /Europe --------------------------------------------------------------------------------> - Japan ------------------------------------------------> Renagel(R) Tablets --------------------------------------------------------------------------------> WelChol(TM) --------------------------------------------------------------------------------> 2nd Generation WelChol(TM) ----------------------------------> C. Difficile Toxin Binder --------------------> Anti-Obesity -----> Oral Iron -----> Psoriasis -----> Mucin ----->
genzyme general MERGER WITH GELTEX - 50/50% cash/stock, tax-free - GelTex shareholders have option of: - $47.50 in cash OR - 0.7272 of share of GENZ - Targeted for completion in Q4 2000 - One-time IP R&D charge to GENZ expected in Q4 2000 - Accounted for as purchase accounting - Dilutive to GENZ near-term earnings - Accretive to earnings in 2002 (before D&A) - Requires GelTex shareholder vote genzyme general THE EVOLUTION OF PHOSPHATE BINDERS - First generation binder - Aluminum in 1980's - Second generation binder - Calcium in 1990's - Calcium binders seen as being problematic for some patients - Third generation binder - Renagel-Registered Trademark- launched in 1998 - Renagel-Registered Trademark-'s role seen initially as: - Helping hypercalcemic patients - Providing lipid benefits - Today - Calcium binders seen by thought leaders as having an unacceptable safety profile - Renagel-Registered Trademark- shows real promise in reducing cardiac morbidity and mortality genzyme general WHAT HAVE WE DONE FOR ESRD PATIENTS? [The following table was depicted as a line chart in the printed material.]
Annual mortality % 1982 1983 1984 1985 1986 1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- ---- Mortality Per Year % 34 34.5 35 34 33 32 31 29 26.4 26 26.4 26 25 25 24.6 24 23
genzyme general Cardiac Death is 30X Greater in Dialysis Patients(1) [The following table was depicted as a bar chart in the printed material.] -------------------------------------------------------------------------------- General Hemodialysis Population Patients ---------- -------- Annual Risk of CV Death 0.3% 9.2% -------------------------------------------------------------------------------- o Risk factors include: o Hypertension o Lipid abnormalities o Smoking o Glucose intolerance o Now - Calcium Load 1. Foley RN, et al. Am J Kidney Dis. 1998;32:S112-S119. genzyme general CLEAR EVIDENCE DEMONSTRATED ELEVATED PHOSPHORUS LEVELS INCREASE MORTALITY RISK(1) IDENTIFIED NEED TO MANAGE MORE AGGRESSIVELY After launch - USRDS showed elevated phosphorus increases mortality risk(1) [The following table was depicted as a bar chart in the printed material.] -------------------------------------------------------------------------------- Relative Mortality Risk (RR) 1.00 1.00 1.02 1.18* 1.39** -------------------------------------------------------------------------------- Serum Phosphorus Quintile (mg/dL) 1.1-4.5 4.6-5.5 5.6-6.5 6.6-7.8 7.9-16.9 -------------------------------------------------------------------------------- *P=0.03 **P less than 0.0001 (N = 6407) 1. Adapted from Block GA, et al. Am J Kidney Dis. 1998;31:607-617. genzyme general ----------------- ECHOCARDIOGRAPHY SHOWED HIGH LEVELS OF VALVULAR CALCIFICATION IN DIALYSIS PATIENTS(1) [The following table was depicted as a bar chart in the printed material.] -------------------------------------------------------------------------------- Mitral Annulus Aortic Annulus -------------- -------------- Percentage of Patients Dialysis 45% 52% Normal 10% 4% -------------------------------------------------------------------------------- 1. Ribeiro S, et al. Nephrol Dial Transplant. 1998;13:2037-2040. genzyme general ----------------- A NEW WAY TO SEE: ELECTRON BEAM COMPUTED TOMOGRAPHY (EBCT) [GRAPHIC OF PATIENT IN CT-SCAN TUBE AND EBCT OMITTED] genzyme general CORONARY-ARTERY CALCIFICATION IN YOUNG ADULTS WITH END-STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS NEW ENGLAND JOURNAL OF MEDICINE, MAY 18, 2000 Source: Goodman, et al - Cardiac calcification is a serious problem - 90% of young adult dialysis patients showed signs of coronary artery calcification - Calcification scores doubled over 17-23 months in 10 patients who showed signs of coronary artery disease doubled genzyme general CORONARY ARTERY CALCIFICATION IN YOUNG DIALYSIS PATIENTS USING EBCT [GRAPHIC SHOWING INCREASE, WITH AGE, IN CORONARY ARTERY CALCIFICATION IN YOUNG DIALYSIS PATIENTS OMITTED] genzyme general EXTENSIVE TRIPLE VESSEL (CORONARY ARTERIES) CALCIFICATION IN A DIALYSIS PATIENT [EBCT IMAGES SHOWING CALCIFICATION IN A DIALYSIS PATIENT OMITTED] Slide courtesy of P. Raggi genzyme general RETROSPECTIVE STUDY: SUGGESTS MORTALITY AND MORBIDITY DIFFERENCES IN MATCHED GROUPS OF RENAGEL-Registered Trademark- AND CONTROL PATIENTS - Groups matched for age, gender, race, diabetic status, hematocrit time on dialysis and hospital stay - Relative risk of hospitalization reduced by approximately 50% (by Cox regression) - Relative risk of death reduced by approximately 33% (by Cox regression) genzyme general SAVINGS TO MEDICARE: $17,000 OR 24% ANNUALLY [The following table was depicted as a bar chart in the printed material.] -------------------------------------------------------------------------------- Control Renagel ------- ------- Inpatient $23,904 $13,788 Outpatient $29,772 $29,076 Other $3,264 $1,152 Physician $13,452 $9,048 Total $70,392 $53,064 Renagel Saving/Yr $17,000 -------------------------------------------------------------------------------- Source: A. Collins, USRDS genzyme general RETROSPECTIVE STUDY: DEATH RATES BY CAUSE (PER 1,000 PATIENT YEARS)
CATEGORY CONTROL RENAGEL-Registered Trademark- All Cause 100.9 66.7 CARDIAC 27.1 14.1 Infectious 12.1 14.8 Unknown 16.2 18.1
SOURCE: A. COLLINS, USRDS genzyme general RENAGEL-Registered Trademark- CLINICAL PROGRAM: CURRENT TREAT TO GOAL STUDY - Vascular calcification is common and progressive in the ESRD population - We are employing a method new to the renal community to detect cardiac and aortic calcification - EBCT - Demonstrate Renagel-Registered Trademark- has expected impact - Prospective randomized study - Renagel-Registered Trademark- vs calcium binders - Multicenter, 225 patients - Timeline - 3 years, 12 month data H1 2001 genzyme general RENAGEL-Registered Trademark- CLINICAL PROGRAM: NEW MORBIDITY & MORTALITY STUDY - Prospective randomized study - 2000 patients - Reduction in hospitalization - 18 months (2003) - Reduction in cardiac mortality - 2.5 years (2004) - Start H1 2001 genzyme general Renagel(R) Total Prescriptions (Quarterly) Q1 99 Q2 99 Q3 99 Q4 99 Q1 00 Q2 00 Q3 00 Renagel 10632 14819 16504 19194 20516 24448 32184 genzyme general Renagel(R) New Prescriptions (Quarterly) Slide 24 Q1 99 Q2 99 Q3 99 Q4 99 Q1 00 Q2 00 Q3 00 Renagel 14813 28076 37282 44627 48308 57007 71376 KEY DRIVERS OF REVENUE GROWTH - Dialysis patient population growing 6 - 8% annually - 1 million now to 1.7 million in 10 years - US population 280,000, Europe 170,000 - Increasing revenue/patient/year - Approximately $1,000 increasing to $2,000 as a result of optimizing dosage levels and compliance improvements - Expanding market share - Strong clinical benefits - Reduction in hospitalization costs genzyme general RENAGEL-Registered Trademark- REVENUES [The following table was depicted as a bar chart in the printed material.] -------------------------- In millions Q4'98 $0.3 1H 1999 $7.6 2H 1999 $11.9 1H 2000 $18.2 2H 2000E $30 -------------------------- genzyme general GENZYME GENERAL UPDATE - Financial update - Marketed products - Pipeline - Infrastructure genzyme general GENZ TOTAL REVENUES [The following table was depicted as a bar chart in the printed material.] --------------------------------- In millions 1990 $ 61 1991 $120 1992 $216 1993 $268 1994 $311 1995 $379 1996 $461 1997 $496 1998 $570 1999 $635 $655* YTD 9/30/00 $549 $549 10-year CAGR: 30.2% --------------------------------- * Includes $20M in Renagel(R) revenues ** Beginning Q2-00 forward, total revenues include Renagel(R) revenues genzyme general GENZ FREE CASH FLOW [The following table was depicted as a bar chart in the printed material.] --------------------------------- (in millions) 1996 ($33.2) 1997 $79.2 1998 $109.9 1999 $131.3 YTD 9/30/00 $132.0 --------------------------------- Free Cash Flow = net income plus depreciation less net cash used for capital expenditures and dividend payments genzyme general THERAPEUTICS PIPELINE EXPANSION [The following table was depicted as a line chart in the printed material.]
----------------------------------------------------------------------------------------------------------------- Number of Products Products in Market New Products Expected in Market ------------------ ------------------ --------------------------------------- 1997 1 Cerezyme(R) ----------------------------------------------------------------------------------------------------------------- 1998 3 ----------------------------------------------------------------------------------------------------------------- 1999 3 Cerezyme(R) Renagel(R) Thyrogen(R) ----------------------------------------------------------------------------------------------------------------- 2000 4 Fabrazyme(TM) ----------------------------------------------------------------------------------------------------------------- 2001 6-7 ATIII AVONEX(R)/Japan 2002 8-10 Aldurazyme(TM) alpha-glucosidase (Pompe disease) DX88 (HAE) Niemann-Pick B ----------------------------------------------------------------------------------------------------------------- Beyond 16+ Lumarel(TM) NeuroCell-PD(TM) PV LSD-GT MS Scleroderma -----------------------------------------------------------------------------------------------------------------
genzyme general Cerezyme(R) Revenues [The following table was depicted as a bar chart in the printed material.] --------------------------- In millions Year US/International 1991 $0/40 1992 $0/93 1993 $31/93 1994 $59/113 1995 $88/127 1996 $119/146 1997 $157/176 1998 $207/204 1999 $239/238 YTD 2000 $200/200 NEAR-TERM PIPELINE: FABRAZYME-TM- FOR FABRY DISEASE - Alpha-galactosidase enzyme deficiency - Kidney failure, cardiac disease, pain/numbness - 2,000-4,000 patients worldwide - Pivotal trial completed ON TIME - Positive Phase 3 results announced at ASHG Oct. 2000 - Target filing - BLA accepted (U.S.); MAA validated (Europe) - No December FDA panel needed; expect FDA action by mid-January genzyme general FABRAZYME-TM- PHASE 3 RESULTS - Adverse events included transient mild to moderate infusion reactions - Easily managed - No significant safety concern for continued therapy - lgG antibodies detected in 24/29 treated patients - Expected since 80% Fabry patients are missing enzyme - Antibody formation did not effect efficacy genzyme general ------------------------------------------------------------------------------- CAPILLARY ENDOTHELIUM SCORE - KIDNEY ------------------------------------------------------------------------------- SCORE AT WEEK 20 POPULATION AS TREATED ------------------------------------------------------------------------------- 0 (NONE) >0 ODDS RATIO P-VALUE ------------------------------------------------------------------------------- Placebo 0 29 (n=29) (0%) (100%) 0.008 LESS THAN 0.0001 r-h (alpha)GAL 20 9 (n=29) (69%) (31%) genzyme general ------------------------------------------------------------------------------- PHASE III EXTENSION - EFFICACY RESULTS ------------------------------------------------------------------------------- KIDNEY -------------------------------------------------------------------------------
ORIGINAL NO. OF NO. OF MONTHS ON %ZERO TREATMENT PATIENTS ZEROS r-h (alpha)GAL PLACEBO 22 22 6 100% r-h (alpha)GAL 21 20 12 95% TOTAL 43 42 98%
genzyme general ------------------------------------------------------------------------------- CONCLUSIONS - Highly statistically significant results in primary endpoint - Safe and well-tolerated - Infusion rates declined in 12-month extension - Placebo crossover in extension study strongly confirms double-blind results - Long-term efficacy maintained genzyme general NEAR-TERM PIPELINE: ALDURAZYME-TM- FOR MPS-I DISEASE - Alpha-L-iduronidase enzyme deficiency - 2,000 - 3,000 patients worldwide [PHOTO] - Joint venture with BioMarin - Begin confirmatory trial: H2 2000 genzyme general MEDIUM-TERM PIPELINE: ALPHA-GLUCOSIDASE FOR POMPE DISEASE - Worldwide license from Synpac/collaboration with Pharming - Estimated 5,000 patients worldwide - Pivotal trial to begin: H2 2000 NIEMANN-PICK B DISEASE - Collaboration with Mt. Sinai School of Medicine - Estimated 1,000 patients worldwide - File IND: H1 2001 AVONEX-Registered Trademark- IN JAPAN - Collaboration with Biogen - Genzyme Japan to manage clinical/regulatory/reimbursement marketing & sales - Target launch: H2 2001 genzyme general MEDIUM-TERM PIPELINE LUMAREL-TM- FOR CYSTIC FIBROSIS - Collaboration with Beth Israel, CF Foundation - Compound corrects lipid imbalance - Estimated 30,000 U.S. patients - File IND by early 2001 DX-88 FOR HEREDITARY ANGIOEDEMA - Collaboration with Dyax - Repeated attacks of swelling, often fatal with no effective therapy - Estimated 5-10,000 patients worldwide - Initiate phase II clinical trial: H2 2000 genzyme general NEW LONGER-TERM CANDIDATES MULTIPLE SCLEROSIS - GENZ-29155 SMALL MOLECULE CANDIDATE - PROGRESSIVE LOSS OF MOBILITY, VISION, AND NEUROLOGIC FUNCTIONS - APPROXIMATELY 350,000 U.S. PATIENTS - LATE PRECLINICAL STAGE SYSTEMIC SCLERODERMA - TGF-BETA ANTAGONIST CANDIDATE - FIBROTIC TISSUE HARDENING OF MAJOR INTERNAL ORGANS, OFTEN FATAL - APPROXIMATELY 70,000 U.S. PATIENTS - LATE PRECLINICAL STAGE genzyme general OUR EMPLOYEES ARE CREATING VALUE WORLDWIDE [The following table was depicted as a graphic in the printed material.]
----------------------------------------------------------------------------------------- Represents percentage of Number of employees outside United States employees ------------------------------- ------------------ Research & Development 5% GREATER THAN 500 Manufacturing/Operations 20% GREATER THAN 1200 Medical/Clinical/Regulatory 35% GREATER THAN 250 Marketing/Sales/Reimbursement 50% GREATER THAN 500 -----------------------------------------------------------------------------------------
genzyme general [PHOTO] GENZYME GENERAL ACCELERATING MOMENTUM...