Cambrex Cell Therapy Buckingham Research Conference Call April 14, 2005
Safe Harbor Statement Today s presentation and discussion will contain forward-looking statements including statements regarding future operating performance, financial or revenue growth targets, or client project pipelines. These statements may be identified by words such as expects, anticipates, intends, estimates, believes or similar expressions. These statements are based on Cambrex s current plans and expectations and involve risks and uncertainties that could cause actual outcomes and results to materially differ from those set forth in the forward-looking statements. For discussion of these and other risks and uncertainties, see the Forward-Looking Statements and Risk Factors That May Affect Future Results sections in the Annual Report Form 10-K for the period ending December 31, 2004. The Company undertakes no obligation to update forward-looking statements. For further information, please refer to Cambrex s reports and filings with the Securities and Exchange Commission.
From Life Sciences to Specialty Pharma Biopharma Contract manufacturing Well positioned in growing life sciences industry Diversified technologies & capabilities Global manufacturing and distribution 31% 11% 58% Sound financials Outstanding regulatory compliance record Proven record of successful acquisition integration Bioproducts for Research, Therapeutics and Testing Human Health Small Molecule APIs and Intermediates 2005E Gross Sales: ~ $465 - $483M
From Drug Discovery to the Patient
Providing Differentiated Drug Development & Manufacturing Solutions General Technologies Organic chemistry Chiral synthesis Biologics Mammalian cell culture Microbial fermentation Yeast, bacterial Normal Human Cells Cell handling expertise and cell culture media Hematopoietic, mesenchymal stem cell systems Specialized Capabilities Controlled substances High potency and containment Radioisotope labeling Hazardous material handling Proprietary Technologies Taste masking Cytotoxicity testing Apoptosis screening Protein kinase assays Rapid microbial detection Endotoxin detection Mycoplasma detection Total viable organism
Secure Global Supply 10 cgmp facilities, plus cgmp pilot plants and kilo labs
Regulatory Compliance Excellence 2-2004 FDA inspections No 483 s EMEA TGA - Australian health authority Health Canada Italian Ministry of Health Irish Medicines Board Swedish Health Authority Belgium Ministry of Health Experience manufacturing approved APIs Over 100 customer audits annually
Sales 000$ 900 800 700 600 Growth Target and Mix Organic Growth Acquisitions 22% Therapeutics/ Technology 500 400 300 58% Human Health 50% Human Health 39% Human Health 200 100 0 11% Biopharma 50% Biosciences 39% Biosciences 31% Bioproducts 2005 2008 2008 With Acquisitions
Leveraging Skills in New Directions: Specialty Pharmaceuticals Advance current partnerships in development e.g. Ortec International Acquire and/or develop pharmaceutical or biopharmaceutical products for niche markets Branded Mid- to late-stage clinical development Enhance products and extend product life cycle with niche technologies (e.g. taste masking)
Pharma Leadership John R. Leone President, CEO Large pharma experience in commercial operations Dan Marshak VP/CTO Industry expert and previously CTO, Osiris, a regenerative medicine company Dave Eansor President, Bioproducts Commercial experience at Cardinal Labs Dave Smith VP/Commercial Development Bioservices Large and emerging pharma sales and marketing experience
Cell Therapy
Cell Therapy Next generation therapeutics are here Potentially curative Localized delivery of therapeutic at target Cells readily available Regenerative rather than palliative Addresses problem not just symptoms Neurology stem cells for Parkinson s Cardiovascular muscle cells to replace damaged tissue (BioHeart) Addresses inherent problems with organ transplantation Limited organ availability Organ rejection Lifetime of immunosuppressive therapy
Cell Therapy Why Now? Regulatory FDA established separate division to review and approve cell therapies Technology New technologies allow for more viable products Automation for improved scaleup and manufacturing processes Release testing (rapid microbial testing, custom assays)
Traditional Basic Technologies Cell Therapy Technologies Minimally Manipulated Technologies Moderately Manipulated Technologies Complex Manipulation Technologies Blood Transfusion Autologous Bone Marrow Transplant Autologous: Critical Organ CNS Therapeutic Bone Matrix Autologous Blood Stem Cell Transplant Allogeneic: Homologous Cells Allogeneic: Non Homologous Cells Scaffold + Growth Factors Autologous: Topical or Peripheral Allogeneic: Blood Stem Cells Immunotherapy Cancer Vaccines Organ Transplants Devices with Living Cells Cell-Based Gene Therapy Regulatory Scrutiny/Time/Risk
Therapy Based on Cells Involved in Disease Neurological disorders: Parkinson s disease, spinal cord injury Cardiovascular disorders, myocardial infarction, congestive heart failure Insulin dependent diabetes mellitus Osteoarthritis Immune and hematological disorders Burns and wounds Disorders of the liver Macular degeneration Osteoporosis Muscular dystrophy Neurons Cardiomyocytes (heart muscle cells) Islet cells of the pancreas Cartilage cells Blood cells Skin cells Hepatocytes (liver cells) Retinal cells Bone cells Skeletal muscle cells
Worldwide Estimated Market Size of Cell Therapy and Related Technologies 90 80 70 60 50 40 30 20 10 0 $81.3B $35.7B $20.2B 2002 2007 2012 Other Cell-based Cancer Vaccines Cell-based Gene Therapy Supporting Technologies Stem cell transplant Tissue Engineering Blood Transfusion Products Source: Jain PharmaBiotech Report 2004
Cambrex Cell Therapy Services
Clinical Cell-Based Services cgmp production facilities US 6 suites EU 4 suites Process development & media optimization units Cell culture media production Tissue acquisition infrastructure Support all types of therapies: Autologous, Allogeneic, Stem cells Integrated quality systems & regulatory services Assay development services Logistics support Raw material & release testing Sales, marketing and distribution services Validation services
Cell Therapy Manufacturing Pipeline Wound Healing (C3) Wound Healing Wound Healing (OrCel) Wound Healing Wound Healing Parkinson s Cardiovascular (BioHeart) Cancer Cardiovascular Renal Disease Cardiovascular Cardiovascular Spinal Cord PI PII PIII Registration Commercial
Some of Our Clients Ortec International Inc. Clinical Cell Culture Ltd.
Wound Care Market
Diabetic Foot Ulcers (DFU) Acute Wound Care Pressure Sores Venous Leg Ulcers (VLU) Treatment of Burns Advanced Wound Management Market Moist Antimicrobial Active Advanced Technologies Hydrogels Silver Biomaterials Tissue Engineering Alginate Growth Factors Scar Prevention Foam Stem Cell Transparent Film Skin Substitutes
Wound Care Market Market $ 1490.9 million in 2004, CAGR 11% through 2011 Hard-To-Heal VLU : 350,000 patients Hard-To-Heal DFU: 500,000 patients No. of Companies More than 20 Tiers of Competition Tier 1: Smith & Nephew (21.5%), J&J (16.5%), Tier 2: ConvaTec, 3M, Kinetic Concepts Tier 3: Novartis, Organogenesis, Fidia, Genzyme Biosurgery, Integra, Medline, Tyco, Urgo End Users Acute care hospitals, wound care clinics, long term facilities, home health facilities Competitive Factors Reimbursement, pricing, product innovation, treatment time, training
Accelerated Skin Regeneration and Wound Healing Keratinocytes and Growth Factors OrCel Epidermis Dermis Bi-layered -optimal growth factor mix Open collagen scaffold -deposited biomatrix -cell migration -re-vascularization Immature cells -highly productive -proliferative -induce rapid regeneration Cryopreserved -extended shelf life -ease of distribution Collagen Fibers, Fibroblasts and Growth Factors OrCel is a registered trademark of Ortec International.
OrCel Facts Improved Efficacy Accelerated wound closure Reduced healing time and pain No induced immune reactions Improved handling properties & delivery system Cryopreserved On-site availability Longer shelf-life Better manufacturing process Reimbursement code available Awaiting PMA Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices.
Cell Therapy Next generation therapeutics Regenerative rather than just palliative Avoids problems with organ transplant Regulatory pathway New technologies support commercially viable products
Cambrex Investment Highlights Well positioned in life sciences and transitioning to specialty pharma Above average growth potential Innovative products and services Diversified products and services base Leading positions in key segments Building on existing technologies and capabilities Moving towards higher growth opportunities Favorable demographics and regulatory environment for therapeutics New technologies for drug discovery and healthcare offer growth opportunities Proprietary products and technologies Development & manufacturing expertise Experience making licensed therapeutics Sales and marketing services Multiple routes to success Strong financial position