datatrak international, inc. (data.pk)
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/197TRANSCRIPT
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
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.
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.
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.
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.
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
DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.
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
The Challenge
DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.
Two High Level Approaches
1. Information Silos & IT Integration
DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.
EDCCTMS
Safety…CodingIVR
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.
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
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
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
DATATRAK Confidential www.datatrak.netDATATRAK ONE ™Safety. Simplicity. Speed.
• 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.
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.
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
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
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.
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.
• 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