Transcript DNA Diagnostic Tests

Greg Hines President & CEO
Sept 2002
Forward Looking Statements
To the extent any statements made in this presentation
deal with information that is not historical, these are
necessarily forward-looking. As such, they are subject to
the occurrence of many events outside of the control of
Tm Bioscience and are subject to various risk factors
that could cause results from Tm Bioscience to differ
materially from those expressed in any forward-looking
statement. The risk factors include, without limitation,
the inherent risk of competition in the marketplace,
outcomes in product development programs, regulatory
risks related to proprietary rights and market
acceptance. Important factors known to Tm Bioscience
that could cause such material differences are identified
and discussed from time to time in filings by Tm
Bioscience.
A DNA-based diagnostics
company
Tm Bioscience
Dual Strategy
1. DNA testing platform
 State-of-the Art Platform
 License platform to Luminex, MetriGenix
 Near-term revenue with high margins
2. DNA tests for potential $16B market
 Four tests in development
 First test to be launched Q1-2003
Why DNA-based Diagnostics?
DNA Diagnostics
Strong Business Case
• Thousands of Genetic Markers
• Better Prediction of Disease
• Strong IP
• High Margins
• Positive Reimbursement Trends
‘”Genomic Bridge between Old and New medicine’’
(David Lewis, Thomas Weisel, 2001)
Genetic Testing Reality
A Rare Commodity:
• Very few tests performed.
• Not yet mainstream healthcare.
• Un-tapped Market
Why is DNA-based Diagnostics an
Un-tapped Market?
Why --- Untapped Market
Technology Gap:
1. Not Accurate
2. Not Affordable
3. Not Fast Enough
DNA-based Diagnostics
Technology Gap
1. DNA Sequencing:
• expensive
• Slow
2. Single gene tests:
• slow
• Can be expensive
3. Microarrays / Biochips:
• Inaccurate
Technology Solution
‘Tm100’ DNA test platform
–Accuracy > 99.9%
–Fast: 9600 DNA tests / hr.
–Economical: pennies / DNA analysis
Tm100 Universal Microarray
Universal Tag “Operating System”
Computers
Microarrays
Toxicology
Coagulation
Cancer
Universal Tags
Tm100 Universal Array
Benefits:
Arthritis
Cardiovascular
Coagulation
P450
Universal
Array
Cancer
Diabetes
CF
Infectious
Disease
• Less
development
time
• High Accuracy
• Lower cost
ONE Array for ALL applications
“ OPEN SYSTEM ”
Tm Bioscience Business
Model
Building Value: A Dual Strategy
Operating System
Out-Licensing
Tm100
Universal Array
Revenue Generating
Near Term
Sustainable
DNA Diagnostic Tests
High Growth
Rapid Development Times
Low Technology Risk
Operating System
Strategy
Industry Standard O. S.
1.
Luminex xMAP™ 100
• >1000 systems placed
• (GSK, Lilly, Mayo,
Abbott, Celera, Lab.
Corp of America, Quest)
2. MetriGenix
• GeneLogic
• Extensive Database
3. Other Platforms
Operating System Revenue
•
•
•
•
Royalty & Milestone
Products
Tm100
Tm1000
Tm100 4D
Tm1000 4D
90,000,000
80,000,000
70,000,000
35 M
60,000,000
50,000,000
40,000,000
30,000,000
20,000,000
1M
10,000,000
0
2002
Yr. 1
2003
2004
Analyst Consensus Estimates
2005
Yr. 5
2006
Diagnostic Test
Strategy
Genetic Testing Market
Research Market 20% CAGR
1B
2001
Research
2B
3B
Affymetrix
2005
2010
Genetic Testing Market
Diagnostic Market 38% CAGR
8B
5B
Affymetrix
2001
Research
Orchid
2005
Diagnostics
2010
Genetic Testing Market
16+ B
Theranostic Market
Affymetrix
2001
Research
2005
Diagnostics
2010
Theranostics
Luminex – An Ideal Partnership
Tm Access to:Luminex Instruments,
Beads, our Universal Array
Opportunity:
Resale Instruments
Design and Market Tests
Broad Based “Fields of Use”
Reduced Cost of Goods
Low Royalty
Tm Competitive Advantage
Low Cost of Goods
• Cross Licensing Leverage (Tm100)
• Tm1000
Time to Market
• Early Access to the Technology
• Broad based Fields of Use
Expertise
• Know-How on the Platform
• Test Development
Low Hanging Fruit
1.
2.
3.
4.
5.
6.
Coagulation
Cystic Fibrosis
Drug Metabolism (P450)
Melanoma
Apo E for Alzheimer’s
Hemoglobinopathies
• Sickle Cell Anemia
• Beta-thalassemias
7. Ashkenazi Jewish panel
8. Hereditary Hearing Loss
9. Congenital Adrenal Hyperplasia
Diagnostic Test
Portfolio
Product Pipeline
P450
2003
Cystic Fibrosis
2003
Coagulation
2003
Design – Develop – Manufacture - Launch
Melanoma
Dr. Hogg U of T
2004
Cystic Fibrosis
• 1 in 29 North Americans is an unknowing
symptom-free carrier of a defective gene
• Current test $400 CDN., 7-10 days
• 600,000 tests conducted / yr
• Fastest (100% CAGR) Growing Genetic test.
• Demand for a new test platform.
“Ob-Gyns will need to incorporate CF
screening into their practice” ACOG
P450
• Drug Metabolism
– Toxicity profile
– Dosing adjustments
• Impacts key pharmaceuticals
(eg. Prozac, Tylenol, Erythromycin, and
>80 other drugs)
• Significant cost driver in healthcare
– Hospital admissions
– Repeat physician visits
• Currently >100,000 tests/yr in USA
Melanoma
• An example of the flexibility of the Universal
Array
• A collaboration between Dr. Hogg (U of T)
and Tm Bioscience
–Dr. Hogg develop the test
–Tm retains commercialization rights
• Will detect genetic mutations which
predispose patients to Melanoma, the most
serious type of skin cancer
• The most common cancer for women aged 25
to 29
Coagulation
‘High Risk Patients’
•
•
17% of population carry blood clotting
mutations
High Risk group are likely to develop
blood clots
1. Major Surgery.
2. Birth Control Meds.
3. Hormone Replacement
4. Pregnancy
“Potential $700 million test market”
Coagulation Product
Tm test will screen for 6 DNA variations
Factor XIII
MTHFR 677
Assay Specs:
Total Time: 4 hours
Factor II
Universal
Array
TFPI
Array Time: < 1 hour
Array Cost: ~ $6.00
Factor V
MTHFR 1298
per test
Coagulation Product
Alpha Testing
•
•
•
Tested 132 DNA Samples
Assayed using Tm 6-plex assay
Compared to DNA sequencing (ABI)
Tm Assay
DNA
Sequencing
Correct Calls
180
171
Ambiguous
calls
0
9
TOTAL
180
180
Coagulation Product
Milestones:
1. Research Prototype
Completed
2.
Validation
Completed
3. Product Launch
Q1 - 2003
Corporate Overview
Management
Greg Hines - President and CEO
(Founding President of Leo Pharma Inc.- Chairman, Rx&D)
Jim Pelot - CFO
(Infospace, VP - NortelNetworks)
Richard Janeczko, Ph.D - Executive VP
(CEO - General Synthesis and Diagnostics)
Roman Zastawny, Ph.D. - VP Product Development
(Allelix Biopharmaceutical, Eli-Lilly)
Jeremy Bridge-Cook, Ph.D. - VP Business Development
(MDS Capital Corp.)
Alan Coley - VP IR and Regulatory
(Eli-Lilly, Leo Pharma)
(+Product Dev & Manufacturing Management)
Board of Directors
Richard Lockie – Chairman
(MDS Capital Corp.)
Neil Reid
(MDS-Sciex, MDS Proteomics)
John Frederick
(Galaen Holdings Ltd.)
Geoffrey Beattie
(The Woodbridge Company Ltd.)
Paul Lucas
(GlaxoSmithKline)
Curtis Cusinato – Secretary
(Stikeman Elliott)
Gregory Hines – President & CEO
Financial Position
Shares Outstanding
Fully Diluted
Recent Price
Market Cap
113.7 M
116.4 M
$0.22
$25 M
Cash reserves
12 month revenue (projected)
Quarterly burn
$7.5 M
$1.5 M
$1.3 M
TSX-VEN: TMC
Key Milestones
 Tm100 Luminex
 Tm 1000 Out license
 2-D platform Partnership
• MetriGenix Launch
Q1-2002
Q2-2002
Q2-2002
Q4-2002
•
•
•
•
2003
2003
2003
2004
Coagulation test
Drug Metabolism test
Cystic Fibrosis test
Melanoma test
Tm Bioscience
Dual Strategy
1. DNA testing platform
 State-of-the Art Platform
 License platform to Luminex, MetriGenix
 Near-term revenue with high margins
2. DNA tests for potential $16B market
 Four tests in development
 First test to be launched Q1-2003
.
www.tmbioscience.com
TSX Venture:TMC