Slide 1: Investor Update January 2018
For personal use only Investor Update January 2018 © 2018 Cogstate Ltd. All rights reserved. 1
Slide 2: Brain health mission statement
For personal use only “ We believe that brain health is profoundly important to quality of life and should be easier to measure. That’s why we so passionately apply our expertise, access to data and flexible technology to simplify the measurement of cognition.” 2
Slide 3: Cogstate Summary
Cogstate Summary For personal use only Exchange: ASX Ticker: CGS Focused on BRAIN HEALTH AND COGNITION • Robust and growing CLINICAL TRIALS BUSINESS FOR MEASUREMENT OF COGNITION - both efficacy (e.g. Alzheimer’s) and safety (e.g. pediatric) endpoints; and • FDA-approved COMPUTER-BASED TEST, COGNIGRA
Slide 4: Leaders In Cognitive Measurement
Leaders In Cognitive Measurement For personal use only Digital brain health assessments and novel technology enhancements for traditional cognitive measures, all driven by science and operational expertise Our proven technology allow clients to We are commercialising our technology measure cognition
Slide 5: Contents
Contents For personal use only 1 Clinical Trials Business Page 6 2 - Computerised cognitive testing Page 14 3 - Scale management, Rater training & Central monitoring Page 21 4 Healthcare Business - Cognigram Page 31 5 Technology Developments Page 38 6 Financial Performance Page 42 7 Leadership & Exp
Slide 6: Clinical Trials Business
For personal use only Clinical Trials Business 6
Slide 7: Complete Solutions for More Reliable Results
Complete Solutions for More Reliable Results For personal use only Scientific Consulting Computerised Scale Assessment Management Reliable Data For Clinical Trial Decision-making Central Monitoring Rater Training Enhanced eCOA 7
Slide 8: What Sets Cogstate Apart
What Sets Cogstate Apart For personal use only Scientific expertise + operational resources to advise and manage assessments in large global programs Innovative approaches to more efficiently drive higher quality outcome measures (i.e. enhanced eCOA + unique rater-centric online training) Sensitive
Slide 9: Broad Experience Across Drug Development
Broad Experience Across Drug Development For personal use only 12 APPROVALS • Latuda (adult and pediatric) • Opdivo • Vyvanse • Vesicare • Samsca • Brintellix • Lyrica • Ketanest-s • Topamax • Repatha • Feraheme 9
Slide 10: Broad Experience Across Drug Development
Broad Experience Across Drug Development For personal use only 12 APPROVALS • Latuda (adult and pediatric) • Opdivo • Vyvanse • Vesicare • Samsca • Brintellix • Lyrica • Ketanest-s • Topamax • Repatha • Feraheme 10
Slide 11: Broad Experience Across Drug Development
Broad Experience Across Drug Development For personal use only 12 APPROVALS • Latuda (adult and pediatric) • Opdivo • Vyvanse • Vesicare • Samsca • Brintellix • Lyrica • Ketanest-s • Topamax • Repatha • Feraheme 11
Slide 12: Enhanced Solutions Delivered in FY17
Enhanced Solutions Delivered in FY17 For personal use only Computerized Cognitive Tablet-based Rater Training Assessment eSource & Monitoring Partnered with Clinical Ink to provide Created a novel eLearning solution Adapted our technology for more that drives efficiencies in the training, flexible,
Slide 13: Global Footprint and Managed Growth
Global Footprint and Managed Growth For personal use only Global Footprint Total Headcount & Active Trials 175 London, UK Boston, MA 107 New Haven, CT Headcount 80 New York, NY 75 # of Trials 63 54 57 44 2014 2015 2016 2017 Melbourne, AU • ~275 team • Managed growth, hiring ahead of demand - 175 ful
Slide 14: Clinical Trials Solution #1: Computerized Cognitive Testing
Clinical Trials Solution #1: For personal use only Computerized Cognitive Testing technology and service solution of scientifically and commercially validated Cogstate computer based assessments 14
Slide 15: Cogstate Computerized Assessment
Cogstate COMPUTERIZED ASSESSMENT For personal use only • DESIGNED FOR CLINICAL TRIALS & BORN IN EARLY PHASE (high usability, acceptability to patients, no effects of language/culture) • High SENSITIVITY TO TRUE COGNITIVE CHANGE in independent studies conducted by large pharma • Success in PHASE I-II
Slide 16: Full Service Solution for Computerised Assessment
Full Service Solution for Computerised Assessment For personal use only SCIENTIFIC CONSULTING Custom batteries with expert input based on your objectives, study design and population TRAINING AND CERTIFICATION Remote, study-specific site training and certification program ensures higher quality and
Slide 17: Validated Through Use in Over 1,500 Studies
Validated Through Use in Over 1,500 Studies Across Academic and Clinical Research For personal use only >50 >90 Countries Languages & Dialects >400 >70 Peer Reviewed Indications Publications 17
Slide 18: Landmark Public-Private Partnership Studies
Landmark Public-Private Partnership Studies For personal use only Cogstate is proud to be involved in the measurement of cognitive function for multiple landmark public-private partnership studies in the area of Alzheimer’s disease: • DIAN Observational Study • DIAN TU Study • DIAN NexGen • AIBL Stu
Slide 19: Changing Landscape of Computerized Cognitive Testing
Changing Landscape of Computerized Cognitive Testing BYOD For personal use only SELF- SUPERVISED ADMINISTERED PROVISIONED HARDWARE 19
Slide 20: Advanced Custom Reporting: Safety Monitoring & Inclusion Eligibility
Advanced Custom Reporting: Safety Monitoring & Inclusion Eligibility For personal use only • Real-time automated analysis of cognitive data • Immediate email notification (alerts are sent to site for inclusion eligibility; alerts are sent to study monitoring teams when detecting cognitive decline) •
Slide 21: Clinical Trials Solution #2: Scale Management, Rater Training, Central Monitoring
Clinical Trials Solution #2: For personal use only Scale Management Rater Training Central Monitoring technology and service solution for delivery, training and centralised review of standardised cognitive assessments 21
Slide 22: Rater Training Program Execution
Rater Training Program Execution For personal use only >65 studies >35 countries > 2,000 sites >50 Languages >4,000 Raters Certified 22
Slide 23: Scale Management Services
Scale Management Services For personal use only Scale licenses Science + Ops are obtained collaborate with from copyright translation vendor holders for methodology Translations & Production Protocol Source Permissions Cultural & Consultation Creation Adaptation Distribution Scientific review of Sou
Slide 24: Innovative Approach To Rater Training
Innovative Approach To Rater Training For personal use only Rethinking lecture-based rater training designed for the Investigator Meeting 24
Slide 25: The Rater Academy Difference
The Rater Academy Difference For personal use only TIME QUALITY SAVINGS • Immersive virtual training • Multi-modality training • Effective eLearning and accelerates site activation, available throughout the certification reduces IM and minimizes site burden study drives accurate ratings attendance (
Slide 26: Central Monitoring of Assessments
For personal use only Central Monitoring of Assessments 26
Slide 27: Scientific Expertise Throughout Study
Scientific Expertise Throughout Study For personal use only Designing of Training and Operational Execution Monitoring and Rater Monitoring Plans Collaboration Across multiple disciplines from Cogstate and external experts, test rater training to statistics, Cogstate Our network of Local Expert auth
Slide 28: Central Monitoring & Remediation – A Strategic Approach
Central Monitoring & Remediation – A Strategic Approach For personal use only Despite robust Quickly identify Identify and correct training, many these rater errors scoring errors raters will make errors in the Prevent them from Identify incorrect study detrimentally administration impacting the pro
Slide 29: Strategic approach to monitoring and remediation
For personal use only REVIEW DATABASE Strategic approach Cogstate’s expert clinical review of grouped, blinded to monitoring and LEADs conduct expert clinical review of scale data to identify aberrant values suggestive of rater administration, scoring, error remediation is and recording to ensure re
Slide 30: An Integrated Solution Drives Endpoint Quality Assurance
An Integrated Solution Drives Endpoint Quality Assurance For personal use only RATER DATA CENTRAL TRAINING CAPTURE MONITORING (Monitoring Informs Refresher Training) 30
Slide 31: Cognigram
For personal use only Cognigram 31
Slide 32: Current Offering
Current Offering For personal use only • 10-15 minute test for clinical care setting • Can be taken at home or in hospital/clinic • Assessment results instantly available to healthcare professionals • Class II medical device • [FDA 510(k) approved] • HIPAA compliant Sensitivity Ease of use Culturall
Slide 33: Cognigram Report for Healthcare Professionals
Cognigram Report for Healthcare Professionals For personal use only Patient & assessment order Information Interactive results and data visualisations Real-time baseline configuration and change score analysis Composite scores (shown) and detailed outcome measures 33
Slide 34: Market Segments & Size
Market Segments & Size For personal use only Application Benefits Detect cognitive decline that • early detection for disease management could be signs of Alzheimer’s or and clinical trial referral Mild Cognitive Impairment • evaluate cognitive state Monitor Drug Side Effect during/after drug therap
Slide 35: Healthcare New Product Roll-Out Status
Healthcare New Product Roll-Out Status For personal use only CognigramTM Global Market Entry Status FDA authorization received Health Canada authorization confirmed Australia TGA authorization confirmed CE Mark work-in-progress Expected in 2018 Cogstate Healthcare 1H FY18 Revenue >$170k (Double Digi
Slide 36: Growth Strategy- Concussion Market
Growth Strategy- Concussion Market Leverage New Product Launch to For personal use only Grow Revenue from Current Customers Expand Customer Base Sample Cognigram List of Existingfor Customers Concussion Evaluation Pro Sports • Planning 3 global webinars featuring prominent users who are concussion t
Slide 37: Growth Strategy- Surgery/POCD
Growth Strategy- Surgery/POCD For personal use only • Post-operative delirium and cognitive dysfunction are common clinical complications among elderly patients – Prevalence: 30-60% elderly patients suffer from post-surgery delirium – Cost: delirium causes significant economic burden to society (cos
Slide 38: Technology Developments
For personal use only Technology Developments 38
Slide 39: Tech Accomplishments (6 Months)
Tech Accomplishments (6 Months) For personal use only Accomplishment Benefit Description Release of Cognigram Market Expansion Expansion of overall Cogstate market with 510k approved application. Pre-screener Reporting Customer Satisfaction Additional reporting options for pre- screener customers. P
Slide 40: Cogstate Technical Strategy
Cogstate Technical Strategy For personal use only We are going to continue to build out our modular cognitive platform adding support for new therapeutic markets, channels and customer applications to deliver our Cogstate services to the market increasing speed, efficiency and quality. • Additional
Slide 41: Single platform for cognitive and functional assessments
Central Monitoring & Rater Engagement For personal use only Central Rating & Adjudication Data Management Electronic Cogstate Paper & Pencil Outcomes Computerized Assessments Assessment Testing (EDC) (eCOA) A single platform to deliver all cognitive and functional assessments together on a single in
Slide 42: Financial Performance
For personal use only Financial Performance 42
Slide 43: Financial Update
Financial Update For personal use only Delivering Against Plan • $21.6 million in new bookings for half year – Nicely diversified portfolio of clients: ongoing studies represent awards from 31 different customers – Important win with the Global Alzheimer’s Program (GAP): announced Jan 2018 – Continu
Slide 44: Clinical Trial Sales Contracts
Clinical Trial Sales Contracts 35,000,000 For personal use only 30,000,000 25,000,000 20,000,000 15,000,000 10,000,000 5,000,000 - FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY17 FY18 (YTD) Notes: Financial Year runs 1 July – 30 June FY18 (YTD) represents the 6 months to 31 December 2017 44
Slide 45: Contracted Revenue Backlog
Contracted Revenue Backlog For personal use only Contracted future revenue ($US) 40,000,000 35,000,000 30,000,000 25,000,000 20,000,000 15,000,000 10,000,000 5,000,000 - 30-06-2015 31-12-2015 30-06-2016 31-12-2016 30-06-2017 31-12-2017 45
Slide 46: Clinical Trials: Book-to-Bill Analysis
Clinical Trials: Book-to-Bill Analysis For personal use only 4.50 (where > 1.0 indicates growth) 4.00 3.50 Book-to-Bill 3.00 2.50 2.00 1.50 1.00 0.50 - Book to Bill Qtr Benchmark 46
Slide 47: FY17 Summary Financial Performance
FY17 Summary Financial Performance For personal use only * *Other operating expenditure, includes employment expenses of A$4.9m (FY16 A$4.6m) inclusive of Board, CEO, COO, Finance team, Legal team, administrative and temporary staff. Those employment expenses are expected to remain consistent from F
Slide 48: Leadership & Expertise
For personal use only Leadership & Expertise 48
Slide 49: Management
Management For personal use only Brad O’Connor CEO ▪ Managing Director and CEO of Cogstate since 2005 ▪ Previously CFO of Cogstate; chartered accountant who holds a Bachelor of Business degree George Hunnewell COO & President of Clinical Trials ▪ 25 years experience growing healthcare technology bus
Slide 50: Board of Directors
Board of Directors For personal use only Audit, Risk Remuneration & Compliance & Nomination Committee Committee Martyn Myer Non-Exec Chairman Yes Chair Founding Director and substantial shareholder Brad O’Connor Chief Executive Officer N/A N/A CEO since December 2005 David Dolby Non-Exec Director No
Slide 51: For personal use only
B Cogstate Ajuo esn feuosied JOS
Slide 52: Appendices
For personal use only Appendices: 52
Slide 53: Clinical Superiority in Detecting POCD: Feature Publication #1
Cogstate’s Clinical Superiority in Detecting Post Operative Cognitive Dysfunction (POCD) Feature Publication #1 Detection of Cognitive Decline After Coronary Surgery: A Comparison of Computerized and Conventional Tests British Journal of Anaesthesia 92 (6): 814±20 (2004) For personal use only Silber
Slide 54: Clinical Superiority in Detecting POCD: Feature Publication #1 (Continued)
Cogstate’s Clinical Superiority in Detecting Post Operative Cognitive Dysfunction (POCD) Feature Publication #1 (Continued) Detection of Cognitive Decline After Coronary Surgery: A Comparison of Computerized and Conventional Tests For personal use only British Journal of Anaesthesia 92 (6): 814±20 (
Slide 55: Clinical Superiority in Detecting POCD: Feature Publication #2
Cogstate’s Clinical Superiority in Detecting Post Operative Cognitive Dysfunction (POCD) Feature Publication #2 Assessment of Cognitive Function Before and After Surgery for Posterior Cranial Fossa Lesions Using Computerized and Conventional Tests For personal use only Neurol Med Chir (Tokyo) 50, 44
Slide 56: Clinical Superiority in Detecting POCD: Feature Publication #2 (Continued)
Cogstate’s Clinical Superiority in Detecting Post Operative Cognitive Dysfunction (POCD) Feature Publication #2 (Continued) Assessment of Cognitive Function Before and After Surgery for Posterior Cranial Fossa Lesions Using Computerized and Conventional Tests For personal use only Neurol Med Chir (T
Slide 57: Clinical Superiority in Detecting POCD: Feature Publication #3
Cogstate’s Clinical Superiority in Detecting Post Operative Cognitive Dysfunction (POCD) Feature Publication #3 Indication of Cognitive Change and Associated Risk Factor after Thoracic Surgery in the Elderly: A Pilot Study For personal use only Frontiers in Aging Neuroscience (December 2017, Volume