DATATRAK International, Inc. (DATA.PK)

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Worldwide Headquarters Mayfield Heights, Ohio 888.677.DATA (3282) Toll Free Bryan, Texas DATATRAK International, Inc. June 30, 2010 OneMedForum-New York Laurence P. Birch Chairman of the Board and CEO

description

DATATRAK delivers end-to-end clinical trial solutions, powerful data management features and a seamless operational experience - all through the delivery method, DATATRAK ONE. Learn more at: http://www.onemedplace.com/database/list/cid/197

Transcript of DATATRAK International, Inc. (DATA.PK)

Page 1: DATATRAK International, Inc. (DATA.PK)

Worldwide HeadquartersMayfield Heights, Ohio 888.677.DATA (3282) Toll Free

Bryan, Texas 979.393.9020www.datatrak.net

DATATRAK International, Inc.June 30, 2010

OneMedForum-New YorkLaurence P. Birch

Chairman of the Board and CEO

Page 2: DATATRAK International, Inc. (DATA.PK)

Forward Looking StatementsThis presentation contains "forward-looking statements" within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of the Company to differ materially from the results expressed or implied by such statements, including the limited operating history on which the Company’s performance can be evaluated; the ability of the Company to continue to enhance its software products to meet customer and market needs, and other factors. Accordingly, there can be no assurance that such expectations will prove to be correct. The Company has no obligation to update or revise any forward-looking information contained in this presentation.

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 3: DATATRAK International, Inc. (DATA.PK)

Corporate Overview

•DATATRAK is a global provider of enterprise clinical trial software and services to life science companies and the research organizations who support them.

Overview•DATATRA

K ONE™•First

eclinical platform on the market

•The only true Unified system

•Leader in clinical data management solutions

Solutions

•Founded 1993 - Operating internet based cloud solutions since 2005

•Acquisition of new technology platform (Citrix Web)

•Continuous investment in robust development

•Managed over 400 studies across 8300 sites with 120,000 patients in 59 countries

History

•Technology pioneer with long history in marketplace

•Increasing backlog with no debt

•Not subject to third-party patents

Financial Record

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 4: DATATRAK International, Inc. (DATA.PK)

About our leadership…• Laurence Birch, CEO and Chairman

– Executive experience in multiple companies including CEO, President and CFO and maintains a CPA certification

– MBA Kellogg School of Business at Northwestern University– Significant turnaround experience – Baxter Healthcare; EDS; Aksys, Ltd; NeoPharm, Inc. and DATATRAK

International– Scaled both Healthcare and IT businesses – eg. Baxter Arthroscopy; EDS Y2K Practice

• Chris Wilke, CTO– 14 years industry experience– Co-developed business plan for eClinical market in 1995

• Implemented early Internet-based registry, 20,000+ patients• Founding member of EMSw; acquired by ClickFind

– Original product architect for eClinical• Bill Coates, VP Sales

– 30+ years business experience, 10+ years industry experience– Experience with eleven acquisitions, four as lead executive– Executive member of management team responsible for growing AMS from 45 to over 700 employees

(sold for $345 million to Fiserv)• Jennifer Fox, CFO

– CPA, M.S. Accounting– 15+ years business experience; 10+ years industry experience– Big 4 public accounting experience – KPMG– Founding principal & CFO of ClickFind – eClinical development team

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 5: DATATRAK International, Inc. (DATA.PK)

DATATRAK International, Inc., A Sound Investment. And Let me Tell you Exactly Why…

• DATATRAK is ready for regulatory challenges• DATATRAK has strong financial fundamentals• Superior product

– Lowers technology AND trial costs• Superior customer service• Dedication and investment in our technology

– Investment is customer and regulatory driven

Growing clinical trial complexity continues to challenge the ability of pharmaceutical and biotechnology companies to contain the ever-rising cost of developing new drugs.

Tufts Center for the Study of Drug Development – May 5, 2010

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 6: DATATRAK International, Inc. (DATA.PK)

eClinical Market

EDC Market Size [EDC and CDM] [William Blair, 03/18/2009]

– 2007 market opportunity was roughly $330 million– Expect it to increase to roughly $745 million in 2012– Growth rate is 15% per year through 2012

IRT Market Size [Randomization and Inventory Management]– Market valued at $250 million in 2008 [William Blair, 03/18/2009]

– Growth around 15% a year [Outsourcing-Pharma.com, 09/09/2008]

Safety Market Size [Coding and PMS] [William Blair, 03/18/2009]

– Market opportunity is approximately $20 million as of 2008 – Expected to grow to roughly $70 million by 2012

CTMS Market Size [CTMS] [Frost and Sullivan; Outsourcing-Pharma.com, 7/15/2008 ]

– Generated revenues of $237.6 million in 2007 – Expected to grow at a rate of 14.5% per year until 2014

Core Lab Market Size [ECGs and Images]– Market valued at $100 million in 2008 [COResearch, 2008]

436.4

287.532.5

311.4

115

EDC IRT Safety CTMS Core Lab

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Page 7: DATATRAK International, Inc. (DATA.PK)

Growth Expectations

DATATRAK Confidential DATATRAK ONE™ Safety – Simplicity – Speed www.datatrak.net

Market 2008

Market 2012

0 200 400 600 800 100012001400160018002000

330

745

250

500

237

450

20

70

100

100

eClinical Market Growth Expectations

EDCIRTCTMSSafetyCore Lab

Dollars in Millions

Year

2012 = $1,865M

2008 = $937M

Page 8: DATATRAK International, Inc. (DATA.PK)

The Challenge

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 9: DATATRAK International, Inc. (DATA.PK)

Two High Level Approaches

1. Information Silos & IT Integration

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

EDCCTMS

Safety…CodingIVR

Page 10: DATATRAK International, Inc. (DATA.PK)

Information Silos & IT Integration Approach:

System Mappings

Contracts

• Integration to create a solution may provide short term gratification – upgrades are difficult and rare.

• Integration often leads to management of multiple vendor contracts.

• Integration typically leads to manual management of data, systems and user accounts.

• Validation of multiple vendors and systems will be required.

Difficult to doProcess Reengineering

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

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Two High Level Approaches

1. Information Silos & IT Integration

2. Unified Platform & Organization

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

EDCCTMS

Safety…CodingIVR

DATATRAK ONE™• One Database• One Process• One Platform• One Unified Suite• One Common Interface• Import / Export Tools

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Unified Platform, Process & Organization Approach

One Process – One Database

System Mappings

Contract

• Unified solutions provide improved usability via one database and one interface.

• Unified solutions reduce the number of vendor contracts.• Unified solutions can enable process improvements.• Validation of single vendor is typically required.

Process Reengineering Easier

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Study Concept

Study Team Assignments

Initial Protocol Development

Regulatory Filings

Regulatory Filings

Protocol Review

Regulatory Review

Protocol Finalization

CRF Development

Site Selection, Contracting,And Training...

IRB Approval

Enrollment, Data Collection, Data Cleaning...

Periodic Safety Review

Protocol AmendmentRegulatory

Authorization

IRB Approval

Periodic Safety Review

First Patient In

Last Patient Out

Database Lock

Data Analysis

Clinical Study Report Creation

Adverse Event Tracking / Management...

Site Payment...

Lab Data Management...

Study Drug Manufacturing, Distribution and Management...

Regulatory Authorization

Efficacy Review...

Budget Development

Automatic ECG Analysis

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Why Unified is BetterIntegrated - Heterogeneous Unified - Homogeneous

Silos of Automation One System

Silos Never Intended / Designed to Talk Seamless Module Communication

Silos Built Independently Common Vendor, Common Technology

Silos need Bridges to Communicate One Underlying Framework

Bridges Limit Data Traffic Optimized Data Flow

Susceptible to Crashes and Bugs Fewer Moving Parts = Fewer Problems

Promise of Real-time Data Visibility Often Not Delivered

Data Always Visible

Increased Maintenance Costs Lower Maintenance Costs

Process Reengineering Hard Process Reengineering Easy

Higher trial budget costs Lower trial budget costs

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Page 14: DATATRAK International, Inc. (DATA.PK)

• Exceed Interoperability Needs– Implement Products in any Combination– Interoperate with Other Vendors of Choice– Leverage Standards

• Construct a Scalable Platform– Provide Superior Performance– Deliver Solutions Online

• Provide Best-of-breed Functionality– Create Trial Initiation-to-Submission Efficiencies– Ensure Ease of Use– Provide Configurable Role-Based Permissions

• Create Single Vendor Efficiencies– Reduce the Number of Contracts– Simplify Design and Validation Efforts– Maintain Flexibility

One Database

DATATRAK ONE™

• One Database• One User Interface• One eClinical Suite

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 15: DATATRAK International, Inc. (DATA.PK)

Safety: Enhanced Visibility Real-Time Reporting & Exporting Process Efficiency

Simplicity: Develop Cross-Study Standards through “eClinical Library” Predictable Cost Structure Unified User Experience

Speed: Faster Trial Start-up Faster Trial Close Data Availability in Real-Time

Benefits of DATATRAK ONE™

Return on Investment

Lower technology costs

Lower overall trial budgets

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 16: DATATRAK International, Inc. (DATA.PK)

First Quarter Results2010 vs. 2009

Unaudited

2009

2010

Revenue $2,086,176 $1,677,650

Direct costs 473,862 302,708

Gross profit 1,612,314 1,374,942

Gross margin 77% 82%

SG&A 2,277,202 1,309,202

Income (loss) from operations (786,864) 10,546

Net income (loss)$ (787,869) $

9,377

DATATRAK Confidential DATATRAK ONE™ Safety – Simplicity – Speed www.datatrak.net

Q3 2009 Q4 2009 Q1 2010

Backlog $8.9M $9.5M $10.7M

Industry Leading Margins

3rd Qtr-Over-Qtr Increase

Q1 New Sales$2,375,000

225% Increase

Profitability

Page 17: DATATRAK International, Inc. (DATA.PK)

2010 UpdatesQ1 2010 Profitability

FIRST TIME FOR DATATRAK TO SHOW PROFIT IN ALMOST 5 YEARS No debt, with exception of trade payables Gross Profit Margin = 82% (2010 Q1)

Improved Backlog Q4 2009 backlog increased 7% over Q3 (2nd consecutive quarter-over-quarter increase) Q1 2010 backlog of $10.673 million (3rd consecutive quarter-over-quarter increase) Current Backlog covers 73% of 2010 projected Expenses

Strengthened Sales Pipeline Q1 2010 New Sales of $2.375 million – 225% increase over 2009

Rationalized Business Model Ability to deliver services is enhanced and strengthened Costs aligned with revenue stream No debt

Removal of Going Concern Qualification by Independent Auditors 12/31/2009 Financial Statements do not include a Going Concern Qualification

Continued Improvement of DATATRAK ONE eclinical Platform Restructured pricing and contracting practices to provide ‘flexibility’ in our models Enhanced import/export tools including CDISC SDTM, and Safety tools Enhanced data entry and cleaning tools Improved learning and knowledge delivery tools Added Advanced character management for Japanese market

DATATRAK Confidential DATATRAK ONE™ Safety – Simplicity – Speed www.datatrak.net

Page 18: DATATRAK International, Inc. (DATA.PK)

Competitive Environment• Acquisition of Phase Forward by Oracle highlights:

– Emphasizes strategic importance of industry– Confirms growth potential of clinical trial space– Legitimizes the market demand for end-to-end solutions like DATATRAK

ONE™

• Market favoring Companies with end-to-end eClinical solutions– DATATRAK has provided this technology longer than any other market

participant– Others are spending heavily in R&D to go where we already are– DATATRAK is the only unified solution available in the market

• As a pioneer of the space, DATATRAK is well positioned for continued growth due to our innovative approach to solving the market’s complexity, financial stability and comprehensive, mature platform.

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 19: DATATRAK International, Inc. (DATA.PK)

Numerous Growth Opportunities

• DATATRAK ONE is the best solution for upcoming changes in the clinical trials industry due to regulatory changes

• DATATRAK ONE is the most developed eclinical platform available

• Increased current eClinical customer relationships• Expanding eClinical Customer Base• Accelerate sales through CRO Channel• Cross-sell DATATRAK ONE products and services

DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.

Page 20: DATATRAK International, Inc. (DATA.PK)

• Increasing Patient Safety• Increasing Process Efficiency

in Clinical and Safety• Data Availability in real time• Cost Reduction in

maintenance, validation, administration and training

• Unified User Experience the eClinical platform, anywhere in the world

• LOWER TRIAL COSTS

DATATRAK WorldwideMayfield Heights, Ohio440-443-0082

Bryan, Texas979.393.9020

EuropeBonn, Germany+49-2226-169-540

www.datatrak.net

DATATRAK ONE™Safety. Simplicity. Speed

DATATRAK ONE™ Difference:

DATATRAK Confidential www.datatrak.net