Cogstate Ltd · ASX:CGS
Cogstate — FY2019 Earnings Presentation
39 slides from Cogstate's earnings presentation, Sep 2, 2019
Slide 1: Investor Presentation
Investor Presentation 2 September 2019 © 2019 Cogstate Ltd. All rights reserved.
Slide 2: Agenda
Agenda Eisai Partnership Capital Raising Financial Results - Cognigram opportunity in Japan, - Placement to Eisai - FY19 financial statements with upfront revenue - Plans for Entitlement Offer - FY20 business outlook FIRST SIGNIFICANT WORKING CAPITAL IMPROVED OUTLOOK IN CLINICAL COMMERCIAL OPPORTUNI
Slide 3: Joining Us Today
Joining Us Today Kazumasa Nagayama Corporate Officer, Chief Strategy Officer, Eisai Co., Ltd. In charge of global corporate strategy, corporate venture investment as well as mid-term planning. 3
Slide 4: Founding Vision
Founding Vision To develop an assessment of brain health that could be used anywhere for any purpose 4
Slide 5: Proprietary computerised tests that deliver heightened sensitivity
Proprietary Automated administration by a non-psychologist, eliminates errors related to scoring and data entry computerised • Paper and pencil tests require that raters compute total scores or analyse performance, increasing the potential for error or variance tests that deliver heightened Assessme
Slide 6: Cogstate combines science, technology and operational expertise
Cogstate combines core capabilities of science, technology and operational expertise to better quantify cognitive change in: Clinical Trials Clinical Practice Academic Research Services and solutions to accelerate Regulatory cleared medical Solutions for researchers studying drug development decisio
Slide 7: Joint Venture
Exclusive in Japan Exclusive license of Cogstate technology in Japan - Cognigram and associated offering, excludes clinical trials - 10 year term with performance criteria at years 5 & 8 Joint Venture Upfront royalty payment US$1m royalty payment made by Eisai to Cogstate Eisai will fund region spec
Slide 8: Capital Raising - Placement
Eisai: US$1.9m (A$2.86m) in two tranches Capital Raising - Initial Placement Issue of 6.7m fully paid ordinary shares at an issue price of $0.20308 Placement per share to Eisai for a total consideration of approx. US$0.9m (A$1.36m). Secondary Placement – subject to shareholder approval Additional ap
Slide 9: Eisai - Corporate Information
Eisai - Corporate Information Date established： December 6, 1941 Capital： 44,986 million yen Other business Neurology Revenue： 642.8 billion yen (FY2018) Consumer 791 area healthcare Stock exchange listings： Tokyo Stock Exchange business 1,774 Employees (consolidated): 10,683 (March 2019) 243 Our Co
Slide 10: Biomarker
Wider Scope of Dementia Prevention Early Activate Regenerative treatment functions medicine Max. Biomarker *1 TSPO PET Amyloid PET *2 CSF tau BAN2401* Hypometabolism MRI Atrophy Cognitive impairment Elenbecestat* Min. High risk Preclinical AD MCI Mild AD Moderate AD Severe AD Cogstate Technology * U
Slide 11: Eisai Neurology Pipeline
Eisai Neurology Pipeline Elenbecestat*1 Early Alzheimer’s disease Phase III ongoing BACE inhibitor BAN2401*1, 2 Early Alzheimer’s disease Phase III ongoing Anti-Aβ protofibrils antibody E2027 Dementia with Lewy bodies Phase II/III ongoing PDE9 inhibitor E2814 Early Alzheimer’s disease Under preparat
Slide 12: Eisai - Medico Societal Innovator
Eisai Dementia Total Inclusive Ecosystem Eisai - Medico Societal Innovator Eisai is aiming to transform from a traditional value chain model to a platform model. Eisai’s goal is to build a dementia ecosystem to address the unmet needs of dementia patients and families, through solutions provided by
Slide 13: Eisai - Medico Societal Innovator
Eisai Dementia Total Inclusive Ecosystem Eisai - Medico Societal Innovator Eisai is aiming to transform from a traditional value chain model to a platform model. e.g. Cogstate Eisai’s goal is to build a dementia ecosystem to address the unmet needs of dementia patients and families, through solution
Slide 14: Dementia in Japan
Dementia in Japan An emerging challenge in an aging society Projected Number of Elderly with Dementia Why do the elderly need long-term care? 14 35 % 33.3% Unknown 2.0% Number of the elderly with dementia Dementia 12 30 % 18.0% 27.0% 11.54 Other 20.1% 24.6% 10 25 % 22.5% 10.16 9.53 20.0% Million peo
Slide 15: Health assessment in Japan
Regular health check: • Includes physical measurement, doctor’s consultation, blood pressure, vision and hearing test, urine test, chest Health assessment x-ray, ECG and blood test • Provided by employer to all employees (no cost to in Japan employee) Specialised medical exam - Ningen Dock Opportuni
Slide 16: Diagnostic Pathway
Diagnostic Pathway: Interaction of cognitive assessment and disease modifying therapy (DMT) 16
Slide 17: Why Eisai has partnered with Cogstate
Why Eisai has partnered with Cogstate Scientifically validated: – Cogstate technology has high sensitivity (80%) and specificity (85%) in MCI – Supported over 1,500 studies across academic and clinical research, including Eisai’s clinical studies for elenbecestat in participants with MCI and early A
Slide 18: Use of Funds
Use of Funds Initial Placement to Eisai (US$0.9m) • Provide scientific, operational and technical support for launch of Cogstate technology in Japan • Other working capital requirements Secondary Placement to Eisai (US$1.0m) • Continue to advance Cogstate technology, including development and valida
Slide 19: Potential Entitlement Offer
Potential Entitlement Offer In consideration of the dilutive nature of the placements to Eisai, as well as the ongoing capital needs of the business, considering undertaking a potential entitlement offer to raise up to US$2 million (A$3m): • the quantum, terms and timing of any such entitlement offe
Slide 20: Working Capital
Working Capital All figures stated in US$ $3.2m cash at 30 June 2019 supplemented by Private Placements and possible Entitlement Offer • $2.8m raised via Placement July 2019 • $1.9m to be raised via Placement to Eisai in two tranches: – $0.9m – $1.0m to be approved by shareholders at Cogstate AGM •
Slide 21: FY19 Results
FY19 Results 21
Slide 22: Financial Analysis
Full Year Ended 30-Jun-18 30-Jun-19 Financial Analysis Revenue from operations Clinical Trials 28,956,884 21,834,374 All results presented in US$ Revenue 28,080,187 21,353,341 Cost of sales (excluding dep'n) (8,548,455) (8,371,688) Gross Margin 19,531,732 12,981,653 Selling, General & Admin costs (3
Slide 23: Analysis of financial results
Analysis of financial results • ↓ Revenue Book | The failure of a series of AD trials dramatically reduced Cogstate’s contracted future revenue, thereby reducing FY19 revenue from already contracted studies by approx. $7m • ↓ Sales Contracts | Uncertainty in respect of AD science resulted in reducti
Slide 24: Cogstate New Business Awards (18 Mos to Date)
Cogstate New Business Awards (18 Mos to Date) Oncology 4% Other 5% AD 15% Depression 8% SZ 13% Rare 22% PD 24% Healthy Vol 9% AD down from ~ 50% in previous 18 months 24
Slide 25: Top CNS Indications Based on Planned Trial Initiations
Top 10 CNS Indications Based on the Number of Planned Trial Initiations in the Next 18 Months Therapeutic Indication Planned Trials Parkinson's Disease 59 Alzheimer's Disease 50 Depression/Stress/Anxiety/Bipolar/MDD 39 Multiple Sclerosis 38 Epilepsy 37 Amyotrophic Lateral Sclerosis (Lou Gehrigs) 24
Slide 26: Clinical Trials Revenue Generation
Clinical Trials Revenue Generation Clinical Trials revenue recognised during the year is a function of: 1. Revenue recognised from the revenue book (contracts on hand at the beginning of the year); and 2. Revenue recognised from sales contracts executed during the year. Clinical trial contract terms
Slide 27: Business & Financial Outlook
Business & Financial Outlook • ↓ Revenue Book | $20.3m contracted future revenue at beginning of FY20 (compared to $28.4m at beginning of FY19) • ↑ Sales Contracts | FY20 Budgeting for more than 50% growth in clinical trial sales contracts (compared to FY19) • ↑ Clinical Trials Revenue | Increased c
Slide 28: What sets Cogstate apart
Proven ability to commercialize highly sensitive What sets computerised cognitive assessments backed by science and carefully designed for the rigor of clinical research Cogstate apart Inclusion of our computerized endpoint in major longitudinal and natural history studies, establishing expected tra
Slide 29: Cogstate
© Cogstate
Slide 30: Appendices
Appendices 30
Slide 31: Commercial Opportunities In Clinical Trials
Commercial Opportunities In Clinical Trials 31
Slide 32: Unmatched experience in Alzheimer's disease
Unmatched • 90 active / completed AD studies experience in • In over 40 countries Alzheimer’s • In over 100 languages / dialects disease across • In all phases of development screening, • Across all stages of disease inclusion, safety, • Pharma, public-private-partnership and and efficacy investigat
Slide 33: Key Growth Areas Beyond AD
Key Growth Areas Beyond AD • Led by KOL, Dr. Pam Ventola, holds co- appointment at Yale Child Study Center; strong capability for creating and adapting novel, disease- specific endpoints Paediatric & Rare Disease • Comprised nearly a quarter of all new business last 18 mos. Parkinson’s Disease • Mul
Slide 34: Key Growth Areas Beyond AD
Key Growth Areas • Rapidly growing area of CNS research (59 trial Beyond AD initiations planned over the next 18 mos*) • Leveraging strong relationships with many AD Paediatric & Rare Disease customers who are now focusing on PD • Ability to support the many other assessments and Parkinson’s Disease
Slide 35: Key Growth Areas Beyond AD
Key Growth Areas • Another active area of CNS research (39 trial initiations Beyond AD planned over the next 18 mos*) • Cogstate computerised tests utilised as part of the overall evaluation of Esketamine, which was granted FDA approval Paediatric & Rare Disease for treatment resistant depression o
Slide 36: Cognigram
Cognigram nT \
Slide 37: Why is the diagnosis of cognitive impairment important?
Why is the diagnosis of cognitive impairment important? 88% $7.9 Treat or reverse causes of Improve health outcomes and TRILLION cognitive decline unrelated to decrease costs of care related Alzheimer’s disease to acute health needs A diagnosis rate of 88% during the Mild Cognitive Impairment stage
Slide 38: Barriers to Cognitive Assessment in Primary Care
Barriers to Cognitive Assessment in Primary Care: Can we harness technology to improve outcomes? 1 2 3 4 Skill Gap Time Gap Standards Gap Reimbursement Gap Not all primary care Cognitive assessment Lack of consensus on Lack of support by global physicians are trained is time intensive the appropriat
Slide 39: Digital Cognitive Assessment System
Digital Cognitive Assessment System Provides simple Can be 10-15 minute assessment of administered at computerised cognitive home or in-clinic cognitive testing impairment or Does not require tool changes over time physician supervision Leverages the Regulatory scientifically clearance: validated Co