• No results found

Life Sciences Tools Industry Background

N/A
N/A
Protected

Academic year: 2021

Share "Life Sciences Tools Industry Background"

Copied!
13
0
0

Loading.... (view fulltext now)

Full text

(1)

October 2003

Life Sciences Tools Industry

Background

This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. 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.

2

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 www.sec.gov 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. 20549, US. For further information about the public reference room, call the SEC at +1 800 732 0330.

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)

3

9

Amersham Biosciences Overview

9

Life Science Tools Overview

9

Industry Dynamics and Challenges

9

Key Segments

9

Key Players

9

Drug Discovery and Development Process

9

Key Technologies

9

Key Amersham Offerings

(3)

5

Customers

– Research Labs, Biotechs,

Pharmaceuticals, Government

Competitors

– Waters, Applied Bio, Agilent,

Perkin Elmer, Invitrogen, Millipore, and others

Financial Summary

Industry Size: ~$15B

Industry Growth: 5 -10%

2000

2003E

Sal

es ($B)

Discovery Systems Protein Separation

$0.9

$1.1

8%

CAGR

OP%

10%

11%

Excellent Product Offering

9

Protein Separations

9

Discovery Systems

High Value-add Delivers High Margins in

Protein Separations

9

30+% OP

Instruments and Flow Business

9

26,000 Unit Installed Base

(Lab +

Production)

Instruments and Reagents for Drug

Discovery and Manufacturing

Enabling Molecular Medicine

14% CAGR

(LTM 1H FY 2003)

Exciting New Platform … Great Business Today & Strategic Homerun

6

Drug Development Process

Discovery

Systems

Development

& Clinicals

Manufacturing

Commercial &

~$25B Global Pharma

Spend … +11% CAGR

400+ New Investigational

Drug Filings Annually

30 New Drugs Approved

Annually

Protein Manufacturing

Capacity Growing 50%

per Year

~$40B Spend on

Development & Clinical

Trials … +12% CAGR

2,300 Total Clinical Trials …

300+ Protein-Based Trials

Discovery &

Research

Protein

Separations

$0.6B

Discovery &

Research &

Development &

Clinical Trials

Commercial &

Manufacturing

$0.5B

+

+

+++

35% Systems

+

+++

--2003E

Revenue

65% Reagents

Amersham Sales to Pharmaceutical Customer Base…

Amersham Participates in All Phases of Process

… New Channel Opportunity for GE Imaging Equipment

($B)

(4)

7 Drug Development Process 300 350 400 450 500 550 No v -9 9 May -00 No v -0 0 May -01 No v -0 1 May -02 No v -0 2

Bio-pharmaceuticals

in Development

# in De ve lopm ent 199 2 199 3 199 4 199 5 199 6 199 7 199 8 199 9 200 0 200 1 200 2 20 0 3 e 20 0 4 e 20 0 5 e 20 0 6 e 0 40 80 120 160 200 Bioprocess sales (£m) No of approved biopharmaceuticals

Demand for Amersham Offerings Driven by

Rapid Growth of Life Sciences & Bio-Pharma

Researchers and Bio-pharma

Companies

Need Large Quantities of

Pure Proteins

for Drug R&D… and

More

for Production

Genomics & Proteomics

DNA Analysis-Understand Basis of Disease… Why ? •Protein Analysis

-Understand Disease Function…How?

Bio-Assays

ScreenPotential Drugs for Impact on Living Cells. • Analyze Drug Candidates for

Toxicology, i.e. Safety

Production Separations

Scale-Up& Large-Scale Biopharma Manufacturing Development & Clinicals Commercial & Manuf’g Discovery & Research

Key Amersham Technologies

Protein

Separations

Lab and Production

Discovery Systems

Sequencing, Genotyping, Expression

Analysis, Protein Analysis, Screening

Well-Positioned with Lots of Ways To Grow

8

(5)

9

Instruments and Reagents for Analytical Studies

$15B

$11B

Life Science Tools

Industrial Tools

• Industrial Applications • Petrochemical • Environmental Testing • Agricultural / Food • Biological Studies • Pharmaceuticals/ Biotech • Drug Discovery &

Development

$26B Industry

Provide Enabling

Technologies for Drug

Development a nd

Molecular Medicine

Source: SDI and GE estimates

Life Sciences Tools: … Enabling Molecular and Personalized Medicine

10

Life Science Tools Industry Dynamics

• Genomics, Sequencing efforts

• NIH Funding

Historic

Drivers:

• Proteomics Sequencing /

Protein Drug Development

• Homeland Defense Funding

Current

Drivers:

$5.5 $6.2 $6.8 $7.3 $7.8 $8.3 $3.6 $4.2 $4.9 $5.7 $6.4 $7.1 1998 1999 2000 2001 2002 2003E $15B $9B ’98 – ’03E 9% CAGR Reagents Instruments

Industry Growth Rates

Growth Shifted from Genomics-Based to Proteomics-Based Tools

Instruments 54% Reagents46%

Segments

Pharmaceutical 40% Government / Academia 40% Biotechnology 20%

Customers

Instruments and Reagents for Use in

the Drug Discovery, Development &

Manufacturing Process

(6)

11

Historical Bottlenecks

9Focused in the Target Discovery Phase 9Historically the Global

Pharmaceutical Industry was built on few targets

Instruments and Reagents Help Biotech and Pharma Overcome New Challenges

New Challenges

9With the advent of the post-human genome era, number of targets discovered has exploded 9Current 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

Key Challenges in Drug Discovery and Development

Discovery & Research

Development

Manufacturing

12

Major Life Sciences Players

Selected Players by Segment …

9

Genomics

Affymetrix , Agilent,

Amersham

, Applied Bio,

Invitrogen, Orchid, Perkin Elmer, Qiagen, Sequenom

9

Proteomics

Agilent,

Amersham

, Applied Bio, Becton Dickinson,

Bio-Rad, Bruker, Invitrogen, Qiagen, Thermo, Waters

9

Bioassays

Amersham

, Becton Dickinson, Beckman Coulter,

Perkin Elmer, Tecan

9

Protein Separations

Amersham

, Bio-Rad, Millipore, Waters, others

9

Molecular Spectroscopy

Bruker, Perkin Elmer, Shimadzu, Thermo, Varian

9

General Lab Equipment

Agilent, Beckman Coulter, Mettler Toledo, Shimadzu,

Thermo, Waters

9

Reagents

Applied Bio,

Amersham

, Becton Dickinson, Bio-Rad,

Invitrogen, Perbio, Qiagen, Sigma Aldrich, Techne

Top Life Science Companies by

2002 Revenue ($B) *

Source: Annual Reports, Analyst Research * Revenues from Life Sciences Only

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

(7)

13

Life Science Customers

Pharmaceutical 40% Government / Academia 40% Biotechnology 20% Top Pharmaceutical Companies by R&D Spending Top Biotech Companies by R&D Spending

Life Science Customer Segments …

8 2002 R&D Spending ($B) 0 2 4 6 Pfize r GSK AstraZ enec a Aven tis Roch e Novar tis Merc k

BMSEli LillyWyeth Source: SEC Reports

Driven by NIH Funding

0 0.5 1 Amge n Gene ntec h Mille nium Biog en Chiro n Genz yme

Source: SEC Reports 2002 R&D Spending ($B)

Source: Deutsche Bank

0 5 10 15 20 25 30 1996 1997 1998 1999 2000 2001 2002 2003 2004E NIH Funding ($B) J&J 14

Instrumentation

Life Sciences Reagents

• High End Equipment for Advanced Scientific Discovery: - Mass Spectrometry - DNA Microarrays - Protein Microarrays - DNA Sequencers - High Throughput Screening -• Productivity Instruments Used for Routine Analysis:

- High Performance Liquid Chromatography

Instruments

$8B Segment

CAGR: 4-8%

Reagents

$7B Segment

CAGR: 7-13%

Instruments

54%

Reagents

46%

Revenue by Segment

2003E

• Consumables Utilized in R&D And Drug Manufacturing • Molecular Biology:

- Cloning and DNA/RNA Manipulation

- Proteins & Immunoassays - Electhrophores Reagents to

Separate, Analyze & Isolate DNA, RNA and Proteins

-• Cell Cultures: - Tissue Culture Media - Animal Sera

- Growth/Attachment Factors • Protein Reagents:

- Protein Expression and Functional Protein Studies

Reagents and Consumables

Two Categories of Life Sciences Tools … Instrumentation And Reagents

(8)

15 9Target Discovery 9Target Validation 9Lead optimization 9Pre-Clinical and Clinical Studies

The Process to Create New Drugs

9Biopharmaceutical Manufacturing

Discovery & Research

Development

Manufacturing

Genomics

Size $3.0B AAGR 9-12%

Proteomics

Size $2.5B AAGR 10-15%

Bioassays

Size $2.0B AAGR 9-12% • Sequencing • Gene Expression • SNP Analysis • Protein Analysis

and Identification • Drug Screening • Toxicology

Amersham Offerings

Protein Separations

Size $1.5B AAGR 10-15% • Protein Purification • Biopharmaceutical manufacturing 9Lead Discovery

Molecular Spectroscopy

Size $1.0B AAGR 3-5%

General Laboratory Equipment

Size $3.0B AAGR 3-5%

The Process...

The Key Segments...

Source: Deutsche Bank, SDI and GE estimates

Bioinformatics /Laboratory Information Management Systems

Size $2.0B AAGR 6-9%

16

Key Technologies Enabling Drug Discovery and Development

Genomics

Definition

• Study of Genes

• Sequencing of organisms to understand gene function • Analysis of genetic variation • DNA Sequencing • DNA Microarrays • Reagents • Study of Proteins • Need to understand gene function in terms of protein activity • Protein-protein interactions • Gel Electrophoresis • Mass Spectroscopy • Reagents

9

9

Key

Technologies

Amersham Offerings

9

9

9

9

Business

Drivers

• Experiments to identify potential drugs suitable to enter human clinical trials • Pharmaceutical companies need to increase productivity in drug discovery to meet revenue growth targets • High Throughput Screening • Reagents

9

Discovery & Research

Development

Manufacturing

Bioassays

Proteomics

Protein

Separations

• Process used for the manufacturing of Biopharmaceuticals • Growing number of approved Biopharmaceuticals and Biopharmaceuticals in Clinical Trials • Liquid Chromatography • Reagents

9

9

9

9

(9)

17

Key Amersham Offerings

18 9Target Discovery 9Target Validation 9Lead optimization 9Pre-Clinical and Clinical Studies

Discovery & Research

Development

Manufacturing

Genomics

Proteomics

Bioassays

• Sequencing MegaBACEtm TempliPhitm Genephortm • Gene Expression CodeLinktm Lucideatm CyeDyetm • SNP Analysis CodeLinktm • Protein Analysis and Identification ETTANtm 2D DIGE Typhoontm • Drug Screening LEADseekertm Cytostar-Ttm Biotraktm • Toxicology IN Cell Analyzertm Custom Labels

Laboratory Information Management System:

Scierratm

Protein Separations

• Protein Purification & Scale-up AKTAtm • Biopharmaceutical manufacturing SepharoseTM Chromaflowtm Sourcetm 9Lead Discovery

Key Amersham Offerings

9Biopharmaceutical

Manufacturing

(10)

19

9

DNA Sequencers are used in first step

of drug discovery to determine the

sequence of nucleotides in a given

sample of DNA

9

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

9

After, the completion of the Human

Genome Project has has shifted to

studies of “companion” genomes.

DNA Sequencers Demand Has Shifted from Human Genome Project

DNA Sequencing

Amersham Offers MegaBACE

TM

,

a Fluorescence-based DNA

Analysis System

MegaBACE

TM

Key Technologies Enabling Drug Discovery and Development

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

Manufacturing

20

9

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

9

Used primarily in Gene Expression

and Genotyping studies for Target

Identification and Target Validation

9

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

Amersham Offers

CodeLink

TM

, DNA Microarrays

for Gene Expression and SNP

Analysis

CodeLink

TM

Key Technologies Enabling Drug Discovery and Development

DNA Microarrays

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

(11)

21

9

Gel Electrophoresis is Technology used

to performed Protein Expression

analysis.

9

Proteins 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

9

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

Core Technology to Perform Protein Expression Analysis

Amersham Offers Ettan

TM

and

2D DIGE

TM,

Integrated Systems

for Protein Expression Analysis

Ettan

TM

Key Technologies Enabling Drug Discovery and Development

Gel Electrophoresis

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

Manufacturing

22

Amersham Offers Ettan

TM

MALDI-TOF, an Integrated Platform for

Protein Analysis and Identification

… Amersham Also Has a Strategic

Alliance With Thermo in This

Segment

9

Mass Spectrometers are used to

identify and quantify analytes through

measuring the molecule mass to

charge ratio

9

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

9

Useful technology for quantification of

compounds and for determining

chemical and structural information

9

Premier methodology for Protein

characterization

Mass Spectrometry Is Leading Technology for Protein Studies

Ettan

TM

MALDI-TOF

Key Technologies Enabling Drug Discovery and Development

Mass Spectrometry

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

(12)

23

Amersham Offers LEADseeker

TM

,

a Multi-Modality System for

Screening Assays Using

Fluorescent, Chemiluminescent

and Radioactive Chemistries

9

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.

9

Demand is driven by the products of

the Human Genome Project , which

has yielded a multitude of targets

against which to screen compounds.

High Throughput Screening Driven by Products of the Human Genome Project

LEADseeker

TM

Key Technologies Enabling Drug Discovery and Development

High Throughput Screening

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

Manufacturing

24

9

Liquid Chromatography systems are

used to separate bio-molecules

according to their hydrophobic/

hydrophilic properties

9

A solution containing the

bio-molecule 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

Liquid Chromatography Is A Key Technology for BioPharma Manufacturing

Amersham Offers AKTA

TM

, a

Chromatography Platform for

Product Purification and

Separation

AKTA

TM

Key Technologies Enabling Drug Discovery and Development

Liquid Chromatography

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

(13)

25

9

Reagents are biological and chemical

materials consumed by scientists

performing experiments to uncover

the sequence and function on genes

9

Three Types of Reagents:

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 Proteins

Reagents Represent Majority of Amersham’s BioSciences Business

65% of Amersham Biosciences

Revenue Derived from Reagents and

Consumables

Amersham Systems Based Reagents

:

MegaBACE

TM

: DNA Sequencing /

Genotyping

Ettan

TM

2D DIGE: Protein Expression

Analysis

Amersham Stand-Alone Reagents:

ECL Advance: Protein Analysis

TempliPhi

TM

: DNA sample preparation

CyDye: Fluorescent Labelling

Genomics

Discovery & Research

Development

Bioassays

Proteomics

Protein

Separations

Manufacturing

Reagents

Key Technologies Enabling Drug Discovery and Development

Reagents

Reagents

Reagents

26

9

Isolation and Purification of Proteins on

Small Scale (Laboratory) and Large

Scale (Bioprocess)

9

Most Commonly Used Techniques Are

Chromatography & Cross-Flow

Filtration

9

Needed for Production Active Drug

Substances in a Highly Pure Form and

in High Yields

9

Very Strict FDA Regulation for the

Manufacturing of Biopharmaceuticals

… FDA Focus on Identity, Purity and

Potency

9

FDA Requires Bio-Equivalence to be

Demonstrated Between Clinical Trial

Process and Commercialized Products

9

Critical for Protein Separations

Suppliers To Get Into Drug

Development Process Early

Protein Separations Enables Production of Pure Protein-Based Drugs at High Yields

Fermenter Removal Ultrafiltration Virus Clearance Capture Cell Harvesting Polishing

Centrifugation and/or filtration Chromatography: Capture target protein, wash away majority of contaminants Chemical/heat/filtration

Removing any particles by filtration

Final chromatography step to remove contaminants very similar to the product Adsorption of contaminants by chromatography

Spotlight on Protein Separations

Protein Separations … Key Technology for Manufacture Biopharmaceuticals

Protein Purification Process … Instruments & Reagents

“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 Protein drugs in development “

References

Related documents

Probation Services currently has an Intensive Supervision Program with electronic monitoring capability and desires to review and understand the advancements in technology and

Greenwood, Democracy and Delaware: The Puzzle of Corporate Law (draft of June 14, 2002). 13 One might say that Delaware cares a great deal about regulating the behavior at

◮ C/T mismatches are not only introduced by the conversion (sequencing errors, SNPs).. What are DNA modifications How to sequence DNA modifications Others. 5mC sequencing

Abstract -- In this study, we have tried to find the numerical solutions of Advection diffusion equation (ADE) by Galerkin method (GM), Adomian decomposition

Arrays of probes covering a genomic region at high Arrays of probes covering a genomic region at high density; no standard definition of probe type ( density; no standard

In comparison to related works, we analysed some important issues for the dynamic reconfiguration support at the ar- chitectural level: foreseen and unforeseen changes; instance

The survey respondents’ perceptions of corruption and anti-corruption strategies will be reflected upon, considering, for instance, whether they felt wages were sufficient to

Figure 3 shows the activation of six units that were chosen as to show the different types of units we identified, and how unit be- havior varies across network layers.. Figure 3(a)