Slide 1: Cogstate Investor Briefing (ASX Announcement)
ASX Announcement 25 August 2021 For personal use only Cogstate Investor Briefing Cogstate (ASX.CGS) has today released an Investor Briefing that provides a summary of the financial results for the year ended 30 June 2021 and also provides a commentary in respect of business and financial outlook. Th
Slide 2: Investor Briefing August 2021
For personal use only Investor Briefing August 2021 PRESENTED BY PRESENTED BY Brad O’Connor Darren Watson CHIEF EXECUTIVE OFFICER CHIEF FINANCIAL OFFICER © 2021 Cogstate Ltd. All rights reserved.
Slide 3: Disclaimer
Disclaimer For personal use only This presentation has been prepared by Cogstate Limited (‘Cogstate’). The information in this presentation is of a general nature and does not purport to be complete, nor does it contain all the information which would be required in a prospectus prepared in accordan
Slide 4: Cogstate Digital Brain Health Strategy
Cogstate Digital Brain Health Strategy For personal use only Market Dynamics & Cogstate Positioning Offering Approval of first ever Alzheimer’s Software therapy & positive data from other • Scientific & commercial validation Alzheimer’s trials • Proprietary digital assessments Services Large and gro
Slide 5: Index
Index For personal use only 1 Business Update 2 FY21 Financial Results 3 First ever disease modifying therapy for Alzheimer’s 4 Adoption of decentralised clinical trials 5 Group Outlook and summary 6 Appendices 4
Slide 6: A milestone year with momentum continuing to build
A milestone year with momentum continuing to build For personal use only Clinical Trials Healthcare Financial Results • A record year in respect of both • Eisai Global agreement with • Record group revenue and new work secured and revenue upfront payment of $15m and demonstrated financial leverage r
Slide 7: Positive Developments Impacting Cogstate Opportunity
Positive Developments Impacting Cogstate Opportunity For personal use only Drug approval has Global licence of Adoption of remote positive impact Cogstate technology (virtual) assessment Aduhelm Approval in USA Eisai Licence Decentralised Trial Design 1. Clinical Trials business will Significant com
Slide 8: Record Start to FY22: Clinical Trials Sales Contracts
Clinical Trials Sales Contracts By Quarter Record Start to FY22 For personal use only 40 $35.4m Clinical Trials Sales 35 Contracts Executed Since 1July 21 30 Cumulative total includes one large 25 phase 3 Alzheimer’s disease trial US$ Million where: 20 • Cogstate’s digital assessments key 15 to dece
Slide 9: FY21 Financial Results
For personal use only FY21 Financial Results 8
Slide 10: FY21 Financial Highlights
FY21 Financial Highlights (All figures in US$) A return to profitability, a solid cash balance and improving outlook For personal use only Record clinical sales contracts executed Record contracted future revenue $47.3m $101.5m Alzheimer’s disease represented 65% of +15% the value of contracts execu
Slide 11: Profit & Loss
Profit & Loss Strong revenue growth driven by US$ Million 1H21 2H21 FY21 FY20* YTY% significant increase in Clinical Trial contracts For personal use only and initial contribution from Eisai Global partnership Revenue 13.9 18.8 32. 7 22. 8 43.5% Revenue and earnings in PCP restated Gross Contributio
Slide 12: Non-Recurring Items
Non-Recurring Items • 1H21 result included -$0.5m one-off Adviser fees associated with the Eisai global agreement For personal use only • 2H21 result included a +$2.4m one-off gain associated with forgiveness of the PPP loan1. All numbers presented in US$ million 1H21 2H21 FY21 EBIT PBT NPAT EBIT PB
Slide 13: Clinical Trials – our established business
Clinical Trials – our established business A record breaking year with strong momentum For personal use only US$ millions 1H21 2H21 FY21 FY20 YTY% into FY22 Revenue 12.6 16.1 28.7 21.1 36.0% • Record revenue driven by the substantial increase in Clinical Trials sales contracts Direct Costs** (6.4) (
Slide 14: Record New Clinical Trials Sales Contracts Executed
Record New Clinical Trials Sales Contracts Executed • New contracts executed in FY21 totalled $47.3m, up 15% on FY20.* • For the first time, contracts executed in 2H exceeded 1H. For personal use only • 2H21 included the first contract awarded via our partnership with ERT (the global leader in clini
Slide 15: Healthcare – our next frontier
Healthcare – our next frontier Landmark 10-year license agreement US$ millions 1H21 2H21 FY21 FY20* YTY% For personal use only • Revenue benefitted from Revenue 1.2 2.6 3.8 1.4 161.8% commencement of the Global licence agreement with Eisai. Approx. $2.9m of revenue recognised in relation to Eisai Di
Slide 16: Record Contracted Revenue Backlog
Record Contracted Revenue Backlog • As at 30 June 2021 contracted revenue backlog was $101.5m, up 151% on pcp ($28.7m to be recognised in FY22).* • Clinical Trials backlog $58.4m ($24.5m to be realised in FY22) For personal use only • Healthcare backlog $43.0M ($4.2m to be realized in FY22). Healthc
Slide 17: Cash Flow
Cash Flow Operating cash flow included: US$ Million FY21 FY20 YTY% • Upfront royalty payment of $13.8m ($15m net of $1.2m costs) from Eisai for Global For personal use only licence in 2Q21. EBITDA 5. 7 (0.9) n/a • Payments of -$0.7m associated with pass-through charges to Clinical Trial Working capi
Slide 18: First ever disease modifying therapy for Alzheimer's
For personal use only First ever disease modifying therapy for Alzheimer’s 17
Slide 19: FDA Approval of Aduhelm
FDA Approval of Aduhelm For personal use only First ever disease modifying treatment of Alzheimer’s to be jointly marketed by Biogen and Eisai • Approved by FDA on 7 June 2021 • Also submitted applications to regulators in: • Europe (Announced Oct 2020) • Japan (Announced Dec 2020) Other late stage
Slide 20: Millions suffer from cognitive impairment such as Alzheimer's
Millions of people around the world suffer from mild to severe cognitive impairment as a result of long-term disease progression such as Alzheimer’s For personal use only • Alzheimer’s accounts for 60-70% of total dementia and is the 6th leading cause of death in the US • Dementia is one of the majo
Slide 21: Alzheimer's therapy approval likely to drive increased R&D investment
Alzheimer’s therapy approval likely to drive increased investment in R&D/Clinical Trials in related therapies For personal use only “ History has shown us that approvals of the first drug in a new category invigorates the field, increases investments in new treatments and encourages greater innovati
Slide 22: Expanded Eisai partnership takes Cogstate closer to its vision
Expanded Eisai partnership takes Cogstate a step closer to realizing its vision For personal use only Global leaders in development and commercialization of a total dementia care ecosystem, from identification to intervention Increasing awareness of Enablers using Cogstate Identifying patients who n
Slide 23: Alzheimer's Opportunity in Healthcare
Alzheimer’s Opportunity in Healthcare For personal use only The FDA approved therapy will require early detection of cognitive decline in order to intervene and slow progression – creating a significant global market for scalable and sensitive dementia screening, particularly for the at-risk age bra
Slide 24: Adoption of decentralised clinical trials
For personal use only Adoption of decentralised clinical trials 23
Slide 25: Decentralised Clinical Trials
Decentralised Clinical Trials For personal use only 1 2 3 4 Dramatic Increase Permanent Change Ripe for disruption Patient centered Since the beginning of There will always be a Conventional clinical trials Not only are decentralised the pandemic, the whole place for trial sites, but the (catering t
Slide 26: Group Outlook and Summary
For personal use only Group Outlook and Summary 25
Slide 27: FY 2022 Outlook
Clinical Trials • Revenue under contract at 1 July of $24.5m For personal use only • Sales contracts executed to date of $35.4m adding approx. $6m to FY22 revenue, taking revenue under contract for FY22 to $30.5m • Historical guide: 2Q’21-4Q’21 saw $39m of new contracts executed, adding approx. $12m
Slide 28: Cogstate Investment Case
Cogstate Investment Case Record revenue backlog with For personal use only Significant leverage to an earnings leverage Alzheimer’s treatment • Momentum in Clinical Trials continues to build • Aduhelm approval crystallises the opportunity (record $58.4m revenue backlog) and record quarterly contract
Slide 29: Appendices
For personal use only Appendices 28
Slide 30: Cogstate Solutions
For personal use only Cogstate Solutions 29
Slide 31: Cogstate Solutions
Cogstate Solutions For personal use only Software Services - Proprietary digital assessment tools - Scientific & operational expertise - Scientific & commercial validation Cogstate technologies provide rapid, reliable and highly sensitive computerized tests to measure cognition, capture data in real
Slide 32: Validated, Proprietary and Scalable Technology
Validated, Proprietary and Scalable Technology Cogstate’s technology platform is clinically validated, accepted by regulators and is For personal use only based on 20+ years of investment and a proprietary data base of cognitive indicators Validated approach Valuable databases Built for growth • Tec
Slide 33: Eisai Background
For personal use only Eisai Background 32
Slide 34: Who is Eisai?
Who is Eisai? For personal use only • Listed on Tokyo Exchange • Market Cap approx. ¥2.61Tn (A$31bn) • Revenue (year to 31 Mar 2020) ¥646bn (A$7.7bn) • Profit before tax: ¥52bn (A$621m) License Agreements • Focusing on dementia as global pioneer since Aricept launch in 1997 • Partnered with Biogen t
Slide 35: Global License
For personal use only • The parties began discussions in 2018 • Japan agreement executed 28 August 2019 - 10-year license from execution - NouKnow (nouknow.jp) product launch occurred 31-Mar-20 initially targeting (i) municipalities Global License providing health services to local residents and (ii
Slide 36: Eisai Commercial Terms
Eisai Commercial Terms For personal use only License Commercials Japan: $1m upfront (received 1Q20) and 50/50 profit split • 2 x 10-year licenses (Japan & Rest-of-World) Rest-of-World (ROW): • No longer has right to terminate ROW after year 5 • US$15m upfront – received in 2Q21 • Includes all Cogsta
Slide 37: Eisai: Revenue vs Cash
Eisai : Revenue vs Cash For personal use only 1 Japan 2 Rest of World Revenue Revenue $1m treated as deferred revenue to be recognised on a $45m treated as deferred revenue to be recognised on a straight- straight-line basis over 10yrs. line basis over 11yrs (10yr term + 12mths to commence) 50/50 pr
Slide 38: FY21 Financial Appendices
For personal use only FY21 Financial Appendices 37
Slide 39: Reconciliation of new contract signings
Reconciliation of new contract signings • In 2020, Cogstate restated the contracted future revenue backlog to exclude third-party services to better reflect For personal use only future net revenue that Cogstate is expected to derive under existing contracts. During 2021, the reported new contract s
Slide 40: Restatement of prior period revenue
Restatement of prior period revenue • Due to the significance of the Eisai global licensing agreement, the group announced in its 1H21 results that it had reviewed the For personal use only application of its accounting policy in respect of revenue relating to the grant of licences, provision of sup
Slide 41: Contracted Future Revenue
Contracted Future Revenue All figures in US$ 31-Jun-21 US$ 31-Mar-21 US$ VARIANCE FAV/(UNFAV) US$ % Contracted Future Contracted Clinical Trials Revenue 58,424,721 55,673,915 2,750,806 4.9 Revenue > $100M as at Eisai License – Global (commercial years 1-10)* 42,211,299 23,191,465 19,019,834 82.0 30
Slide 42: Cogstate
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