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GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing & Personalized Medicine

GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing & Personalized Medicine

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GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing & Personalized Medicine. Forward-Looking Statements. - PowerPoint PPT Presentation

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Page 1: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

GenMark DiagnosticsSuperior Solutions for Multiplex Molecular Testing & Personalized Medicine

Page 2: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Forward-Looking Statements This presentation contains forward-looking statements about GenMark Diagnostics, Inc. These statements involve known and unknown risks that relate to the Company’s future events or future financial performance and the actual results could differ materially from those discussed in this presentation, including Factors that may cause the Company's actual results to differ materially from those discussed in the presentation, include:•failure to obtain sufficient funding for the continued development and commercialization of the Company's products;•failure to expand the Company's menu of diagnostic tests, including the failure to obtain licenses to additional biomarkers on commercially reasonable terms;•increases in the Company's projected expenditures on sales and marketing, research and development and administrative activities;•less than anticipated growth in the market for diagnostic testing generally and for the tests the Company is developing or may develop in the future;•failure of the Company's products to gain market acceptance domestically or internationally;•inability to obtain regulatory clearance or approval for any of the Company's products;•changes in the regulatory environment which may adversely impact the commercialization of the Company's new products and result in significant additional capital expenditures;•failure to enter into or maintain successful strategic alliances, which may delay the development or commercialization of the Company's products or may result in significant additional expenditures;•inability to attract or retain skilled personnel for the Company's product development and commercialization efforts;•inability to protect the Company's intellectual property and operate the Company's business without infringing upon the intellectual rights of others, which could result in litigation and significant expenditures;•refusal of third-party payors to reimburse the Company's customers for use of diagnostic systems and tests; and•failure to develop the Company's next-generation AD-8 System with the capabilities the Company intends to offer.

Additional risks and uncertainties relating to the Company and its business can be found in the "Risk Factors" section of GenMark's Registration Statement on Form S-1. The forward-looking statements contained in this presentation represent the Company’s estimates and assumptions only as of the date of this presentation and the Company undertakes no duty or obligation to update or revise publicly any forward-looking statements contained in this presentation as a result of new information, future events or changes in the Company’s expectations.

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Page 3: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Business Evolution

3

Life Sciences

Original Technology invented by Jon Faiz Kayyem, PhD

Caltech Innovation

Osmetech plc acquires Clinical Micro Sensors

AIM Listed

XT8 Platform Developed

Clinical Micro Sensors acquired by Motorola

1st Generation eSensor Platform Developed

1995 2000 2005 2010

Consolidate all Ops in San Diego

New Board and Management

New Commercial Team

New menu-driven strategy

Nasdaq Listing

$100M+ invested in tech/product development and IP

Page 4: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Large Growing MarketMultiplex Molecular Diagnostics growing ~14% CAGR

4

Source: Kalorama, Frost and Sullivan, L.E.K. 2009

Main Growth Drivers Genomics discoveries Conversion from “LDT” to IVD Decentralization

Areas of high growth (est. CAGR) Personalized medicine (38%) Infectious disease panels (>14%) Oncology (16%)

U.S. MDx Supplier Revenues$ Billions

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

$3.4B

*Estimated

*Forecast

*Forecast

$1.9B

$1.3BInfectiousDisease

14%

Mycobac,RVP, other

Specific Tests

Blood Screening 4%

Genetic Disease7%

Oncology 16%

PGx 38%

Other* 17%

Percentages represent segment specific CAGR

Page 5: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Fragmented Competition

5

Companies listed are representativePositioning reflects management’s current opinion and is subject to change

Low-plex

Multiplex

Centralized Decentralized

Increasing Emphasis on Multiplex IVD MDx

Page 6: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

~1000 Labs with Limited Menu

500 Full Service MDx Labs

35,000+ Physician office and other

Laboratories

~4500 Labs not currently running MDx

XT-8 SystemPost-PCR – 1000 Labs

Target Customers: US only

GenMark Target Customers

6

Page 7: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

GenMark: Simplified, Standardized, Scalable

7

Amplified Patient Sample

Add Proprietary

LabelLoad mixture onto cartridge

Patient Results Reported

Insert cartridge into XT-8

Page 8: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

The GenMark eSensor Technology

8

Capture Probe

Signal Probe

Ferrocene Label

Target DNA

Hybridization Produces Electrochemical Signal

Electronic DNA detection

Highly specific and sensitive

No washing or purification steps

Extremely stable chemistry

Heavily protected Intellectual Property

Fully Developed and Commercialized

Page 9: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

9

Sources: Package Inserts, LEK Market Research, Scientific Conference Posters

GenMark’s Competitive Advantage

Reliable No operator interpretation No calibration required Virtually maintenance free Ease of Test Development

Convenient Workflow Minimal sample handling Easy-to-use software interface Easily Integrated & Scalable platform

Superior Quality Fast processing – 30 minutes 100% accuracy in multiple IVD products Minimal DNA input required

Page 10: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

The Business ModelPlacements + Menu = Reagent Annuity

0

120

60

30

90

Rev

enu

e ($

M)

0 500100 200 300 400Instruments

2 tests/system

4 tests/system

6 tests/system

8 tests/system

For illustration only. Model assumes an average annual revenue per test per instrument of $30K.

10

Page 11: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Business Strategy

11

Commercial Execution

High Value IVD Menu

Development

NexGen Sample to

Answer Platform

Page 12: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Business Strategy

12

Commercial Execution

High Value IVD Menu

Development

NexGen Sample to

Answer Platform

Page 13: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

FDA Cleared IVD Tests

13

Source: LEK, AEI-Brookings Joint Center, Management estimates

Warfarin Sensitivity 2 Million new patients/year in US alone Genetic testing recommended by FDA and PBMs NIH clinical outcomes study underway

Cystic Fibrosis Genotyping For couples, expecting couples, newborn

screening/confirmation Addresses an estimated $70M US market ACOG/ACMG recommended Panel

Thrombophilia Risk Test (TRT) Factor V Leiden, Factor II Prothrombin & MTHFR Thrombophilia disorders affect 1 in 1000 individuals Only cleared test for MTHFR 1298

Page 14: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

In Development for FDA submission

14

Respiratory Viral Panel (RVP) Approx. 20 upper respiratory viruses including H1N1 Immuno-compromised and high risk patients 200,000+ people hospitalized w/ respiratory infections annually

Plavix Metabolism (2C19) Over 1.6 million new US prescriptions annually Tests for gene variations on Plavix label Indicates reduced effectiveness in 2-14% of patients

Source: Frost and Sullivan, FDA statement, L.E.K. 2009

K-ras Mutation Tests for mutations related to colorectal cancer treatments Over 200,000 US patients with related forms of cancer Rules out anti-EGFR therapy if mutation is present

Page 15: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Future Menu Development

Test Name Market Opportunity

Lower Respiratory Tract Infections Community Acquired Pneumonia

Central Nervous System Infections Meningitis and Encephalitis

Hepatitis C Virus Genotyping Type and Subtype

2D6 Tamoxifen Metabolism Breast Cancer

EGFR Pathway Colorectal and Other Cancers

Human Papillomavirus Genotyping High Risk Typing/Cervical Cancer

15

Page 16: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Business Strategy

16

Commercial Execution

High Value IVD Menu

Development

NexGen Sample to

Answer Platform

Page 17: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Commercial Execution

Target 1,000 top molecular laboratories

Flexible placement strategies to accelerate market uptake

–System sales, leases and reagent rental agreements

Ten Field Sales/Support representatives expanding to twenty +

Recruiting and training highly productive “A” players

Marketing support with key opinion leaders, physician tools, publications and trade shows

Establishing International distributor network

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Page 18: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

The Road to Operational Excellence

• Best in Class Quality System• Conversion to Lean Manufacturing Operations• Upgraded ERP system• Highly Efficient Customer Service & Support Interface

Page 19: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Business Strategy

19

Commercial Execution

High Value IVD Menu

Development

NexGen Sample to

Answer Platform

Page 20: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Next Gen Feasibility Completed

Sample to Answer Capability

Based on XT-8 system and cartridge

Integrates Extraction and PCR

Engineering/Systems Integration Partner

Selection Process Underway

PCR tube Exochamber

Hybuffer

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Sample to Answer Multiplexed Molecular IVD Testing

Page 21: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

~1000 Labs with Limited Menu

500 Full Service MDx Labs

35,000+ Physician office and other

Laboratories

~4500 Labs not currently running MDx

AD-8 SystemSample-To-Answer

5000+ Labs

Target Customers: US only

Target Customers

21

Page 22: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

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Summary Statement of Operationsunaudited($ in thousands) 2008 2009 Q1 2010 Q2 2010 Q3 2010 YTD 2010

Revenue $647 $998 $399 $651 $667 $1,717

Gross Loss -2,591 -3,334 -168 -212 -554 -934

             

Sales & Marketing 3,394 3,182 1,058 1,204 1,109 3,371

R&D 13,424 5,634 1,454 1,724 1,669 4,847

G&A 9,633 8,289 2,167 2,002 1,592 5,761

Operating Loss -29,041 -20,438 -4,847 -5,142 -4,924 -14,913

             

Net Loss -28,363 -19,963 -4,849 -5,137 -4,917 -14,903

Operating cash use ($26,169) ($15,444) ($4,982) ($4,127) ($4,481) ($13,590)

Page 23: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

23

Summary Balance Sheetunaudited

($ in thousands) September 30, 2010

Cash $24,144

AR & Inventory 1,273

Other assets 491

PPE, Intangibles, other 2,461

Total Assets 28,369

AP & Accrued Comp 2,481

Other liabilities 1,768

Stockholders Equity 24,120

Liabilities & Equity 28,369

Page 24: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Installed Base Steadily Growing

Page 25: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Reagent Revenue Increasing

62%

82%

62%

82%

164%

Page 26: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Accelerating Annuity per System

Page 27: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

Investment Highlights

27

Expanding $2+ billion Market, High Growth Multiplex Segment

Management Team and Board with proven record

Attractive Reagent Annuity Business Model Driven by High Value,

Clinically Relevant, IVD Molecular Tests

Fully Developed, Simple to Use FDA-cleared Platform

Deep pipeline of products in development for FDA submission

Extensive IP portfolio with 94 patents approved in the US

Page 28: GenMark Diagnostics Superior Solutions for Multiplex Molecular Testing  & Personalized Medicine

GenMark DiagnosticsSuperior Solutions for Multiplex Molecular Testing & Personalized Medicine