Life Sciences Tools Industry Background
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- Jeffery Shelton
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1 Life Sciences Tools Industry Background October 2003 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of Forward-looking statements may be identified by words such as "expects", "anticipates","intends", "plans", "believes", "seeks", "estimates", "will" or words of similar meaning and include, but are not limited to, statements about the expected future business and financial performance of GE resulting from and following the Acquisition. These statements are based on management's current expectations and are inherently subject to uncertainties and changes in circumstances. Among the factors that could cause actual results to differ materially from those described in the forward-looking statements are factors relating to satisfaction of the Pre-Conditions and the Conditions, GE s ability to successfully combine the businesses of GE Medical Systems and Amersham and to realize expected operating synergies from the Acquisition, and changes in global, political, economic, business, competitive, market and regulatory forces. More detailed information about certain of these factors is contained in GE s and Amersham s filings with the SEC. Neither GE nor Amersham undertakes any obligation to update the forward-looking statements to reflect actual results, or any change in events, conditions, assumptions or other factors. The foregoing does not constitute an offer for sale of any securities or an offer or an invitation to purchase any such securities. If and when GE commences its proposed acquisition of Amersham and the acquisition is implemented by way of a scheme of arrangement, any securities to be issued pursuant to the scheme of arrangement will not be registered under the Securities Act but will be issued in reliance on the exemption provided by Section 3(a)(10) thereof, and Amersham will furnish the acquisition document to the SEC under cover of a Form 6-K. If and when GE commences its proposed acquisition of Amersham and the acquisition is implemented by way of an offer rather than a scheme of arrangement, GE will file a registration statement relating to the offer with the SEC. If GE files a registration statement with the SEC, it will contain a prospectus and other documents relating to the offer. Such prospectus and other documents will contain important information about GE, Amersham, the offer and related matters. Holders of Amersham securities who are U.S. persons or who are located in the United States are urged to read such prospectus (if any) and other documents that would form part of such registration statement if and when it becomes available before they make any decision with respect to the offer. Holders of Amersham securities should also read the related solicitation/recommendation statement on Schedule 14D-9 that will be filed with the SEC by Amersham relating to the offer. Such prospectus and any other relevant documents filed by GE and Amersham with the SEC will be available free of charge at the SEC s web site at and from GE. These documents will also be available for inspection and copying at the public reference room maintained by the SEC at 450 Fifth Street, N.W., Washington, D.C , US. For further information about the public reference room, call the SEC at The directors of GE accept responsibility for the information contained in this presentation. To the best of the knowledge and belief of the directors of GE (who have taken all reasonable care to ensure that such is the case), the information contained in this presentation for which they are responsible is in accordance with the facts and does not omit anything likely to affect the import of such information. The contents of this presentation are not intended to mean that General Electric earnings or earnings per share for any period will necessarily exceed those of any prior year. 2
2 Amersham Biosciences Overview Life Science Tools Overview Industry Dynamics and Challenges Key Segments Key Players Drug Discovery and Process Key Technologies Key Amersham Offerings 3 4
3 Enabling Molecular Medicine Instruments and for Drug Discovery and Excellent Product Offering Discovery Systems High Value-add Delivers High Margins in 30+% OP Instruments and Flow Business 26,000 Unit Installed Base (Lab + Production) Customers Research Labs, Biotechs, Pharmaceuticals, Government Competitors Waters, Applied Bio, Agilent, Perkin Elmer, Invitrogen, Millipore, and others Sales ($B) Financial Summary Industry Size: ~$15B Industry Growth: 5-10% 8% CAGR $0.9 $ E OP% 10% 11% (LTM 1H FY 2003) 14% CAGR Separation Discovery Systems Exciting 5 New Platform Great Business Today & Strategic Homerun Amersham Participates in All Phases of Process Discovery & Research & ~$25B Global Pharma Spend +11% CAGR 400+ New Investigational Drug Filings Annually Drug Process & Clinical Trials ~$40B Spend on & Clinical Trials +12% CAGR 2,300 Total Clinical Trials Based Trials Commercial & 30 New Drugs Approved Annually Capacity Growing 50% per Year Amersham Sales to Pharmaceutical Customer Base 35% Systems 65% ($B) Discovery Systems 2003E Revenue $0.6B Discovery & Research & Clinicals Commercial & $0.5B New Channel Opportunity for GE Imaging Equipment 6 Entry Into Largest Segment In Healthcare Drug
4 Demand for Amersham Offerings Driven by Rapid Growth of Life Sciences & Bio-Pharma # in Bio-pharmaceuticals in Nov-99 May-00 Nov-00 May-01 Nov-01 May-02 Nov-02 Drug Process Discovery & Research & Clinicals Key Amersham Technologies & DNA Analysis - Understand Basis of Disease Why? Analysis - Understand Disease Function How? Bio-Assays Screen Potential Drugs for Impact on Living Cells. Analyze Drug Candidates for Toxicology, i.e. Safety Discovery Systems Sequencing, Genotyping, Expression Analysis, Analysis, Screening Bioprocess sales ( m) No of approved biopharmaceuticals Commercial &Manuf g Production Scale-Up & Large-Scale Biopharma Lab and Production e 2004e 2005e 2006e 40 0 Researchers and Bio-pharma Companies Need Large Quantities of Pure s for Drug R&D and More for Production 7 Well-Positioned with Lots of Ways To Grow Life Science Tools Overview 8
5 Instruments and for Analytical Studies $26B Industry Industrial Tools Life Science Tools Industrial Applications Petrochemical Environmental Testing Agricultural / Food $11B $15B Biological Studies Pharmaceuticals/ Biotech Drug Discovery & Source: SDI and GE estimates Provide Enabling Technologies for Drug a nd Molecular Medicine 9 Life Sciences Tools: Enabling Molecular and Personalized Medicine Life Science Tools Industry Dynamics Instruments and for Use in the Drug Discovery, & Process Industry Growth Rates 98 03E 9% CAGR $15B Instruments 54% Segments 46% Instruments $7.1 $6.4 $9B $5.7 $4.9 $4.2 $3.6 $5.5 $6.2 $6.8 $7.3 $7.8 $8.3 Customers E Source: Deutsche Bank, SDI and GE estimates Government / Academia 40% Biotechnology 20% Pharmaceutical 40% Historic Drivers: Current Drivers:, Sequencing efforts NIH Funding Sequencing / Drug Homeland Defense Funding Growth Shifted from -Based to -Based Tools 10
6 Key Challenges in Drug Discovery and New Challenges Historical Bottlenecks Focused in the Target Discovery Phase Historically the Global Pharmaceutical Industry was built on few targets With the advent of the post-human genome era, number of targets discovered has exploded Current challenges for pharmaceutical companies include: Validating new targets Reducing the drug development time Faster prediction of drug failure Rescue of drugs with utility for patients with certain genetic makeup Instruments and Help Biotech and Pharma Overcome New Challenges 11 Major Life Sciences Players Top Life Science Companies by 2002 Revenue ($B) * Applied Bio $1.7 Thermo Electron $1.2 Amersham $1.0 Shimadzu $1.0 Perkin Elmer $1.0 Waters $0.9 Millipore $0.7 Invitrogen $0.6 Becton Dickinson $0.6 Mettler Toledo $0.6 Beckman Coulter $0.6 Agilent $0.5 Varian $0.5 Bio-Rad $0.4 Affymetrix $0.3 Sigma Aldrich $0.3 Qiagen $0.3 Source: Annual Reports, Analyst Research * Revenues from Life Sciences Only 12 Selected Players by Segment Affymetrix, Agilent, Amersham, Applied Bio, Invitrogen, Orchid, Perkin Elmer, Qiagen, Sequenom Agilent, Amersham, Applied Bio, Becton Dickinson, Bio-Rad, Bruker, Invitrogen, Qiagen, Thermo, Waters Amersham, Becton Dickinson, Beckman Coulter, Perkin Elmer, Tecan Amersham, Bio-Rad, Millipore, Waters, others Molecular Spectroscopy Bruker, Perkin Elmer, Shimadzu, Thermo, Varian General Lab Equipment Agilent, Beckman Coulter, Mettler Toledo, Shimadzu, Thermo, Waters Applied Bio, Amersham, Becton Dickinson, Bio-Rad, Invitrogen, Perbio, Qiagen, Sigma Aldrich, Techne
7 Life Science Customers Life Science Customer Segments Pharmaceutical 40% Government / Academia 40% Top Pharmaceutical Companies by R&D Spending Driven by NIH Funding 2002 R&D Spending ($B) Pfizer GSK AstraZeneca Aventis Roche NIH Funding ($B) J&J Novartis Merck BMS Eli Lilly Wyeth Source: SEC Reports E Source: Deutsche Bank Biotechnology 20% Top Biotech Companies by R&D Spending 2002 R&D Spending ($B) Amgen Genentech Millenium Biogen Chiron Genzyme Source: SEC Reports 13 Life Sciences Tools Two Categories of Life Sciences Tools Instrumentation And Instrumentation High End Equipment for Advanced Scientific Discovery: - Mass Spectrometry - DNA Microarrays - Microarrays - DNA Sequencers - High Throughput Screening - Productivity Instruments Used for Routine Analysis: - High Performance Liquid Chromatography Instruments 54% Revenue by Segment 2003E 46% Life Sciences and Consumables Consumables Utilized in R&D And Drug Molecular Biology: - Cloning and DNA/RNA Manipulation - s & Immunoassays - Electhrophores to Separate, Analyze & Isolate DNA, RNA and s - Cell Cultures: - Tissue Culture Media - Animal Sera - Growth/Attachment Factors : - Expression and Functional Studies Instruments $8B Segment CAGR: 4-8% $7B Segment CAGR: 7-13% 14
8 The Process... The Process to Create New Drugs Target Discovery Target Validation Lead Discovery Lead optimization Pre-Clinical and Clinical Studies Biopharmaceutical The Key Segments... Size $3.0B AAGR 9-12% Sequencing Gene Expression SNP Analysis Size $2.5B AAGR 10-15% Analysis and Identification Size $2.0B AAGR 9-12% Drug Screening Toxicology Size $1.5B AAGR 10-15% Purification Biopharmaceutical manufacturing Bioinformatics /Laboratory Information Management Systems Size $2.0B AAGR 6-9% Molecular Spectroscopy Size $1.0B AAGR 3-5% General Laboratory Equipment Size $3.0B AAGR 3-5% Source: Deutsche Bank, SDI and GE estimates Amersham Offerings 15 Key Technologies Enabling Drug Discovery and Definition Study of Genes Study of s Experiments to identify potential drugs suitable to enter human clinical trials Process used for the manufacturing of Biopharmaceuticals Business Drivers Sequencing of organisms to understand gene function Analysis of genetic variation Need to understand gene function in terms of protein activity -protein interactions Pharmaceutical companies need to increase productivity in drug discovery to meet revenue growth targets Growing number of approved Biopharmaceuticals and Biopharmaceuticals in Clinical Trials DNA Sequencing Gel Electrophoresis High Throughput Liquid Screening Key Chromatography DNA Microarrays Mass Spectroscopy Technologies 16 Amersham Offerings
9 Key Amersham Offerings 17 Key Amersham Offerings Target Discovery Target Validation Lead Discovery Lead optimization Pre-Clinical and Clinical Studies Biopharmaceutical Sequencing MegaBACE tm TempliPhi tm Genephor tm Gene Expression CodeLink tm Lucidea tm CyeDye tm SNP Analysis CodeLink tm Analysis and Identification ETTAN tm 2D DIGE Typhoon tm Drug Screening LEADseeker tm Cytostar-T tm Biotrak tm Toxicology IN Cell Analyzer tm Custom Labels Purification & Scale-up AKTA tm Biopharmaceutical manufacturing Sepharose TM Chromaflow tm Source tm Laboratory Information Management System: Scierra tm Source: Amersham 18
10 Key Technologies Enabling Drug Discovery and DNA Sequencing DNA Sequencers are used in first step of drug discovery to determine the sequence of nucleotides in a given sample of DNA Systems that break apart a sample of DNA, tag each of its nucleotides with a different color and uses a laser beam to cause the tagged nucleotides to fluoresce. The colors are optically scanned and a sequence of nucleotides is established After, the completion of the Human Genome Project has has shifted to studies of companion genomes. Amersham Offers MegaBACE TM, a Fluorescence-based DNA Analysis System MegaBACE TM 19 DNA Sequencers Demand Has Shifted from Human Genome Project Key Technologies Enabling Drug Discovery and DNA Microarrays DNA Microarrays are Glass wafers coded with complementary sequences of Genes. DNA Probes bind to their complements in a given biological sample through a technique known as hybridization Amersham Offers CodeLink TM, DNA Microarrays for Gene Expression and SNP Analysis Used primarily in Gene Expression and Genotyping studies for Target Identification and Target Validation Can be also used for Toxicology Studies, during clinical trials to stratify patient groups, and for diagnosis and Prognosis Have the potential to be used for Pharmacogenomics CodeLink TM 20
11 Gel Electrophoresis is Technology used to performed Expression analysis. Key Technologies Enabling Drug Discovery and Gel Electrophoresis s are separated on a gel by their charge and size, and appear as spots on the gel. The gel is then digested with an enzyme and the proteins are isolated for further analysis using an instruments such as a Mass Spectrometers Gel Electrophoresis systems can offer one- and two-dimensional separation, with the latter providing more detailed analysis as proteins are separated horizontally and vertically across the gel Amersham Offers Ettan TM and 2D DIGE TM, Integrated Systems for Expression Analysis Ettan TM 21 Core Technology to Perform Expression Analysis Key Technologies Enabling Drug Discovery and Mass Spectrometers are used to identify and quantify analytes through measuring the molecule mass to charge ratio A sample is converted into positively or negatively charged particles that then proceeds into a mass analyzer, where using a magnetic field the particles are separated based on mass Useful technology for quantification of compounds and for determining chemical and structural information Premier methodology for characterization Mass Spectrometry Amersham Offers Ettan TM MALDI- TOF, an Integrated Platform for Analysis and Identification Amersham Also Has a Strategic Alliance With Thermo in This Segment Ettan TM MALDI-TOF 22 Mass Spectrometry Is Leading Technology for Studies
12 Key Technologies Enabling Drug Discovery and High Throughput Screening High Throughput Screening technology includes the use of liquid handling and sample preparation products and detection systems to screen hundreds of thousands of compounds for biological activity against a test assay, to identify potential drug candidates. Demand is driven by the products of the Human Genome Project, which has yielded a multitude of targets against which to screen compounds. Amersham Offers LEADseeker TM, a Multi-Modality System for Screening Assays Using Fluorescent, Chemiluminescent and Radioactive Chemistries LEADseeker TM High Throughput Screening Driven by Products of the Human Genome Project 23 Key Technologies Enabling Drug Discovery and Liquid Chromatography Liquid Chromatography systems are used to separate bio-molecules according to their hydrophobic/ hydrophilic properties A solution containing the biomolecule to be isolated together with a number of other contaminants is poured down a column packed with resins. The target bio-molecules and some contaminants bind to these resins and are detached in turn when buffers are passed down the column Amersham Offers AKTA TM, a Chromatography Platform for Product Purification and Separation AKTA TM 24 Liquid Chromatography Is A Key Technology for BioPharma
13 Key Technologies Enabling Drug Discovery and are biological and chemical materials consumed by scientists performing experiments to uncover the sequence and function on genes Three Types of : Molecular Biology: Used for the studies of genes and proteins Cell Culture: Used in both Research and Bioproduction Chromatography Consumables: Used for separation, identification and characterization of s 65% of Amersham Biosciences Revenue Derived from and Consumables Amersham Systems Based : MegaBACE TM : DNA Sequencing / Genotyping Ettan TM 2D DIGE: Expression Analysis Amersham Stand-Alone : ECL Advance: Analysis TempliPhi TM : DNA sample preparation CyDye: Fluorescent Labelling 25 Represent Majority of Amersham s BioSciences Business Spotlight on Key Technology for Manufacture Biopharmaceuticals Biopharmaceuticals, or protein-based drugs, represent the most attractive classes of therapeutic compounds in the market generating over $24B in revenue in 2002, an increase of 34% over 2001 with more than 400 drugs in development 26 Fermenter Cell Harvesting Capture Virus Clearance Ultrafiltration Removal Polishing Source: UBS Warburg Purification Process Instruments & Centrifugation and/or filtration Chromatography: Capture target protein, wash away majority of contaminants Chemical/heat/filtration Removing any particles by filtration Adsorption of contaminants by chromatography Final chromatography step to remove contaminants very similar to the product Isolation and Purification of s on Small Scale (Laboratory) and Large Scale (Bioprocess) Most Commonly Used Techniques Are Chromatography & Cross-Flow Filtration Needed for Production Active Drug Substances in a Highly Pure Form and in High Yields Very Strict FDA Regulation for the of Biopharmaceuticals FDA Focus on Identity, Purity and Potency FDA Requires Bio-Equivalence to be Demonstrated Between Clinical Trial Process and Commercialized Products Critical for Suppliers To Get Into Drug Process Early Enables Production of Pure -Based Drugs at High Yields
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