-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, FKC1hraCZs8FvTDaNoS08wnAGg5IDHtYW4QuRo9hm9pCMiE16yoXRvcKGqTOv+pw /TQ84DpWFuyfsY8dQNn2fw== 0000912057-00-011295.txt : 20000314 0000912057-00-011295.hdr.sgml : 20000314 ACCESSION NUMBER: 0000912057-00-011295 CONFORMED SUBMISSION TYPE: 425 PUBLIC DOCUMENT COUNT: 1 FILED AS OF DATE: 20000313 SUBJECT COMPANY: COMPANY DATA: COMPANY CONFORMED NAME: BIOMATRIX INC CENTRAL INDEX KEY: 0000747952 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133058261 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 425 SEC ACT: SEC FILE NUMBER: 001-14221 FILM NUMBER: 568280 BUSINESS ADDRESS: STREET 1: 65 RAILROAD AVE CITY: RIDGEFIELD STATE: NJ ZIP: 07657 BUSINESS PHONE: 2019459550 MAIL ADDRESS: STREET 1: 65 RAILROAD AVE STREET 2: 65 RAILROAD AVE CITY: RIDGEFIELD STATE: NJ ZIP: 07657 FILED BY: COMPANY DATA: COMPANY CONFORMED NAME: GENZYME CORP CENTRAL INDEX KEY: 0000732485 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 061047163 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 425 BUSINESS ADDRESS: STREET 1: ONE KENDALL SQ CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: 6172527500 MAIL ADDRESS: STREET 1: ONE KENDALL SQUARE CITY: CAMBRIDGE STATE: MA ZIP: 02139 425 1 FORM 425 Filed by Genzyme Corporation (Commission File No. 000-14680) Pursuant to Rule 425 under the Securities Act of 1933 and deemed filed pursuant to Rule 14a-12 of the Securities Exchange Act of 1934 Subject Companies: Biomatrix, Inc. (Commission File No. 001-14221) and Genzyme Corporation's Surgical Products Division and Tissue Repair Division [The following is the text of slides from a slide show being presented in meetings with analysts, potential investors and others.] SLIDE: FORWARD-LOOKING STATEMENTS This presentation contains forward-looking statements. Actual results may differ materially. Risk factors described on Form 8-K filed on June 11, 1999 SLIDE: INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS RELATING TO THE MERGER TO BE FILED WITH THE SECURITIES AND EXCHANGE COMMISSION BECAUSE IT WILL CONTAIN IMPORTANT INFORMATION. THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER DOCUMENTS FILED BY GENZYME AND BIOMATRIX WITH THE COMMISSION MAY BE OBTAINED WHEN THEY BECOME AVAILABLE FOR FREE AT THE COMMISSION'S WEB SITE (WWW.SEC.GOV). THE JOINT PROXY STATEMENT/PROSPECTUS AND THESE OTHER DOCUMENTS MAY ALSO BE OBTAINED FOR FREE FROM GENZYME OR BIOMATRIX, AS THE CASE MAY BE. REQUESTS TO GENZYME SHOULD MAY BE DIRECTED TO GENZYME CORPORATION, ONE KENDALL SQUARE, BUILDING 1400, CAMBRIDGE, MASSACHUSETTS 02139, ATTN: CORPORATE COMMUNICATIONS (617) 252-7500, OR YOU CAN ACCESS DOCUMENTS ON ITS WEBSITE (WWW.GENZYME.COM). REQUESTS TO BIOMATRIX SHOULD BE DIRECTED TO BIOMATRIX, INC., 65 RAILROAD AVENUE, RIDGEFIELD, NEW JERSEY 07657, ATTN: INVESTOR RELATIONS (201) 945-9550 OR YOU CAN ACCESS DOCUMENTS ON ITS WEBSITE (WWW.BIOMATRIX.COM). SLIDE: PIONEERING BIOSURGERY SLIDE: PIONEERING BIOSURGERY: CONVERGENCE OF MECHANICAL AND BIOLOGICAL APPROACHES /--------------------/----------------------------/ Medical / / Pharmaceuticals / MARKETS / / Biotechnology / / Ge/nzyme / /--------------------/----------------------------/ Surgical / / / / Bi/oSurgery / / Devices / / /--------------------/----------------------------/ Mechanical Biological PRODUCTS CREATING A UNIQUE COMPANY...DEFINING A UNIQUE MARKet SLIDE: BIOSURGERY - EMERGING FROM TWO TECHNOLOGY PLATFORMS - Biomaterials - Cell therapy With opportunities to leverage conventional biotech and pharma technologies: - Gene therapy - Proteins - Small molecules -2- SLIDE: BIOSURGERY - THREE HIGH POTENTIAL GROWTH MARKETS - Orthopedic Surgery - Cardiothoracic Surgery - Neurosurgery SLIDE: CREATING A NEW ENTERPRISE: GENZYME BIOSURGERY [in box] Genzyme Surgical (NASD: GZSP) - Pioneer in BioSurgery [in box] Genzyme Tissue Repair (NASD: GZSP) - Leader in Bio-orthopedics [in box] Biomatrix (NYSE: BXM - Pioneer in viscoelastic medical products [arrows are pointing from boxes above to one box containing text: "GENZYME BIOSURGERY"] SLIDE: GENZYME BIOSURGERY - Proposed ticker (NASD:GZBX) - 35 million shares outstanding - Biomatrix shareholders -- $250M +/- cash -- 47% of GZBX (Exchange 1 for 1) - Genzyme Tissue Repair shareholders -- 27% of GZBX (Exchange 0.3352) - Genzyme Surgical Products shareholders -- 26% of GZBX (Exchange 0.6060) SLIDE: CREATING A NEW FORM OF BIOTECH COMPANY - High value products, early in their life cycles - A high value pipeline resting on well-regarded scientific platforms -3- - Expertise and infrastructure to build a global business SLIDE: HIGH GROWTH EARLY LIFE CYCLE PRODUCTS - Bio-orthopedic -- Synvisc(R) -- Carticel(R) - Cardiothoracic -- Beating heart CABG instruments -- FocalSeal(R) -L* - Adhesion prevention -- Seprafilm(TM) -- Sepramesh(TM) * -- Hylasine(R)* *Pending FDA approval SLIDE: A HIGH VALUE PIPELINE - Bio-orthopedics -- Carticel II for cartilage damage -- OA5025 for osteoarthritis -- Synvisc (other joints) - Bio-CV -- Gene therapy for serious heart disease - HIF-1(alpha) for angiogenesis - BARKct for congestive heart failure -- Cell therapy for heart muscle scarring -- Biomaterials - FocalSeal-L for CV applications - CV Sepra - Adhesion Prevention -4- SLIDE: EXPERTISE AND INFRASTRUCTURE - 1,300 employees worldwide - 6 manufacturing plants - Access to Genzyme Corporation's 450 scientists and 180 clinical and regulatory staff - Established US and European sales forces in orthopedics and cardiothoracic surgery - Product sales capabilities in GREATER THAN 70 countries SLIDE: FINANCIAL STRENGTH - Revenue of GREATER THAN $250M - Revenue growth 30% - Positive cash earnings per share - GREATER THAN $100M Cash - Substantial market capitalization SLIDE: BIO-ORTHOPEDICS We are focused on the fundamental problems of connective tissue damage in joints whether caused by disease or traumatic injury SLIDE: BIO-ORTHOPEDICS - Biologically based solutions for musculo-skeletal problems - The two defining products -- Carticel(R): cell therapy for cartilage repair -- Synvisc(R) : biomaterial for osteoarthritis -5- SLIDE: CARTILAGE DAMAGE - 1.7 million knee arthroscopies in 1999 in US - 600,000 ACL injuries - 650,000 meniscal tears - 500,000 articular cartilage defects ~95,000 clinically significant ~40,000 repeat treatments Source: Piper Jaffray Company Estimates SLIDE: CARTILAGE REPAIR TREATMENT ALTERNATIVES - Debridement and lavage - Abrasion - Microfracture - Osteochondral autografts - Carticel(R) SLIDE: CARTICEL(R) TREATMENT [Diagram illustrating a biopsy from tissue [Diagram showing an injection of with a defect.] Carticel(R)] [Picture captioned "cGMP Cell Processing"] Periosteal flap
-6- SLIDE: CONTINUED LONG-TERM IMPROVEMENT - Cartilage Repair Registry - Chronicles progress of patients treated - 85% patient improvement 3 years post-op - 4-year data to be released in March 2000 at American Academy of Orthopedic Surgeons (AAOS) meeting SLIDE: OSTEOARTHRITIS - 13.7 million diagnosed knee OA patients in US - 600,000 of which have severe OA - 6-8 million moderate - 4.5 million are beyond initial treatment (management by oral Rx, physical therapy) - 3.8 million treated by specialists familiar with HA therapy (ORS/RHU) SLIDE: OSTEOARTHRITIS TREATMENT ALTERNATIVES - Oral pain medications - Viscosupplementation - Surgical debridement and lavage - Total knee replacement -6- SLIDE: SYNVISC(R) REPLACING OSTEOARTHRITIC SYNOVIAL FLUID [Picture showing packaging of Synvisc(R) Hylan G-F 20.] - 3 intra-articular injections - Provides long term relief for osteoarthritic knee pain - Recommended for those who have failed simple analgesics and physical therapy - Marketed by 6 major pharmaceutical companies worldwide SLIDE: VISCOSUPPLEMENTATION IN CHANGING OA MARKET - Medicare total knee replacements down 5% in 1998 - Double digit Increases for the last 10 years - 10 plus increases forecasted - Opinion Leaders document delay in TKR - Leading implant companies seeking market entry in US - New data supports use in mild to moderate OA SLIDE: COMPETITORS: US MARKET
PRODUCT PARTNER MKT. STATUS Hyalgan Sanofi/Orthologic LESS THAN 20% US share Orthovisc Zimmer 2nd US trial begun Artz Smith & Nephew Unknown Fermathrom Biomet Unknown
-8- SLIDE: PHYSICAL DIFFERENCES CAN BE VISIBLE [Pictures showing consistency of Synvisc(R) and Hyalgan] Synvisc(R) Hyalgan SLIDE: BIO-ORTHOPEDIC PRODUCT PIPELINE
RESEARCH PRECLINICAL CLINICAL DEVELOPMENT DEVELOPMENT Concept [right arrow] Market [up arrow] [up arrow] Synvisc Hylagel Nuro Carticel [up arrow] [up arrow] Quicktack Orthevac OA5025 Carticel II Tissue Welding Tevdek Sepra ORS Synvisc: other joints TGF (beta) Synvisc Plus Bondek ORS
SLIDE: BIO-ORTHOPEDIC STRENGTHS - GREATER THAN $100M in revenue growing GREATER THAN 30% - Two direct sales forces plus six pharma distribution partners worldwide - Expanding high value pipeline SLIDE: BIO-CARDIO We are focused on serious heart and lung disease including serious ischemia and advanced congestive heart failure [Picture of surgeons operating.] -9- SLIDE: SERIES CARDIOTHORACIC ILLNESS - More than 1 million mechanical procedures/year in the US -- Over 7 million people suffer from angina - Advanced congestive heart failure -- 1.6 million with class III or IV -- 400,000 more patients each year - 200,000 thoracic procedures SLIDE: ATTACKING SERIOUS HEART DISEASE THROUGH... Biotherapeutics [right arrow] Biomaterials [right arrow] Devices SLIDE: ATTACKING SERIOUS HEART DISEASE THROUGH... Biotherapeutics [right arrow] Biomaterials [right arrow] Devices - Gene Therapy - Cell Therapy - Protein Therapy - Drug Discovery SLIDE: BIOTHERAPEUTICS - Gene Therapy - Therapeutic Angiogenesis [Picture of a heart.] - Restenosis - Congestive Heart Failure - Cell Therapy - heart muscle repair -10- SLIDE: GENE THERAPY CLINICAL STATUS - Lead gene therapy product HIF-1 (alpha) (Hypoxia Inducible Factor) - 3Q 1999 Phase I Peripheral Vascular Disease - 1H 2000 Phase I clinical Ischemic Heart Disease SLIDE: INDUCTION OF GENE EXPRESSION BY HYPOXIA Sensor Heme - 0(2) Sensor Heme [arrow pointing down] 0(2) [up arrow] 0(2) [up arrow] HIF - 1(alpha) [arrows pointing to each below] Anaerobic Metabolism Angiogenesis Vasodiliation Erythropoiesis Other Glycolytic Enzymes Nitric Oxide EPO Genes VEGF Synthase VEGF-R SLIDE: HIF-1(alpha) VEGF 165 A [picture demonstrating method of inducing angiogenesis for the treatment of ischemic heart disease] Angiography HIF - 1 (alpha) B [picture demonstrating method of inducing angiogenesis for the treatment of ischemic heart disease] (beta)-gal C [picture demonstrating method of inducing angiogenesis for the treatment of ischemic heart disease]
SLIDE: CELL THERAPY RESEARCH -11- - Cell therapy for damaged heart muscle - Post-MI scarring is initial target - Collaborations with academic researchers - Early preclinical studies show promise - Considerable Genzyme expertise SLIDE: ATTACKING SERIOUS HEART DISEASE THROUGH... Biotherapeutics [right arrow] Biomaterials [right arrow] Devices - Gene Therapy - Sepra(R) Products - Cell Therapy - FocalSeal(R)- L - Other SLIDE: SEPRA(R) IN CARDIOTHORACIC SURGERY - 1999 CV-Seprafilm(R) approved in Europe for use in Coronary Artery Bypass Grafting surgery - 3Q 1999 initiated pivotal trial in U.S. for cardiac surgery adhesion prevention - 1H 2000 begin clinical trial preventing adhesion following left-ventricular assist device implantation SLIDE: FOCAL PARTNERSHIP ADDS BIOMATERIALS DEPTH - GZBX to sell Focal's surgical sealant in North America - First labeled indication: air leaks in lung surgery - $70M North America market opportunity - Complement product portfolio - Expect FDA approval and launch in 2000 -12- SLIDE: ATTACKING SERIOUS HEART DISEASE THROUGH... Biotherapeutics [right arrow] Biomaterials [right arrow] Devices - Gene Therapy - Sepra(R) Products - Chest Drains - Cell Therapy - FocalSeal(R)- L - Instruments - Other - Sutures - Minimally - Invasive - Instruments SLIDE: OPCAB ELITE(TM) WITH COHN CARDIAC STABILIZer(TM) [Pictures of OPCAB Elite(TM) and Cohn Cardiac Stabilizer(TM)] -13- SLIDE: GENZYME CARDIOTHORACIC PRODUCT PIPELINE
RESEARCH PRECLINICAL CLINICAL DEVELOPMENT DEVELOPMENT CONCEPT [right arrow] MARKET [arrow up] [arrow up] FocalSeal(R) - L MISCV Sepra Film(R) [arrow up] Seprafilm(TM) II - Adhesions [arrow up] Gene Therapy - Angiogenesis [arrow up] Sepra Coat(R) - Atrial Fibrillation [arrow up] Cell Therapy - Ventricular Restoration [arrow up] Cell Therapy (Ventricular Aneurysm) Drug Delivery [arrow up] - Atrial Fibrillation Surface Modification - Local, Sustained Anesthetic Gene Therapy - CHF - Restenosis
SLIDE: BIO-CARDIO STRENGTHS - GREATER THAN $90 million in revenue growing 20% - Well established brands - Well respected direct sales force augmented by strong distribution worldwide - High value pipeline -14- SLIDE: ADHESION DISEASE IS A MAJOR PROBLEM [Picture of small bowel adhesion] - Additional opportunities exist - abdominal and colorectal - gynecology - cardiac - sinus - neuro - orthopedics - Market potential exceeds $500 million SLIDE: GZBX IS A LEADER IN ADHESION PREVENTION Step 1: Establish Sepra Film(R) as standard of care in colorectal surgery Step 2: Expand Sepra(R) family New Formulations New Anti-Adhesion Applications - Sepra Film(R) - Hernia Repair - Sepragel(R) - Cardiovascular surgery - Sepramesh(TM) - Sinus Surgery - Sepra Coat(R) - Laparoscopic surgery - Hylasine(R) - Orthopedics - Hylagel(R) Nuro SLIDE: CREATING A NEW FORM OF BIOTECH COMPANY - High value products, early in their life cycles - A high value pipeline resting on well-regarded scientific platforms - Expertise and infrastructure to build a global business - Critical mass in emerging markets -15- * * * * * * * * * * * This filing contains forward-looking statements, including statements regarding the consummation of the transactions, the creation of a newly publicly traded stock, the impact of the transactions on Genzyme Corp.'s, Genzyme Tissue Repair's, Genzyme Surgical Products' and Biomatrix's respective earnings and financial positions, the future growth and success of Genzyme Biosurgery, Genzyme Biosurgery's impact on Genzyme Corp.'s involvement in the bio-orthopedic and cardiothoracic markets, the potential market introduction of new orthopedic and cardiothoracic surgery products, surgical devices and biomaterials, expected revenues based on new products, the sufficiency of the cash and other resources of Genzyme Biosurgery, the tax-free nature of the transaction and the expected allocation of Genzyme Biosurgery common stock. Actual results may differ materially from those indicated depending on many factors including conditions in the financial markets relevant to the proposed transaction, the likelihood of regulatory and other approvals of the transactions, the operational integration associated with the transaction and other risks generally associated with such transactions, the accuracy of information about the biosurgery market, the competitive environment for the biosurgery market, market acceptance of Genzyme Biosurgery's products and services, delays in the production or development of Genzyme Biosurgery's products, the enrollment rate for clinical trials, the ability of Genzyme Biosurgery and/or its partners to manufacture sufficient quantities of products for clinical trials, the ability to successfully complete preclinical and clinical development of products, the actual safety and efficacy of products, the timing and content of submissions to and decisions by the FDA and other regulatory authorities, the continued funding of collaborations and programs by Genzyme Corp., Genzyme Biosurgery and/or their partners and the ability of Genzyme Biosurgery and/or its partners to successfully commercialize products. -16- -----END PRIVACY-ENHANCED MESSAGE-----