Emyria Ltd · ASX:EMD
Emyria — Emerald Clinics — Investor Presentation (March 2020)
23 slides from Emyria's investor presentation, Mar 5, 2020
Slide 1: Evidence Generating Care
For personal use only Evidence Generating Care www.emeraldclinics.com.au Investor Presentation – March 2020 Michael Winlo – MD & CEO Adam James – COO
Slide 2: Disclaimer and notices
Disclaimer and notices For personal use only This presentation has been prepared by Emerald Clinics Limited ACN 625 085 734 (Company or Emerald). This presentation is not a financial product or investment advice or recommendation, offer or invitation by any person or to any person to sell or purchas
Slide 3: There is a massive evidence gap for cannabinoid products
There is a massive evidence gap for cannabinoid products For personal use only Evidence gap creates a chasm to mainstream adoption Forces constrained access through special access schemes Restricts patient access and clinical studies Evidence Gap Constrains the commercial potential of the industry L
Slide 4: This gap creates significant challenges for stakeholder adoption
This gap creates significant challenges for stakeholder adoption For personal use only 4
Slide 5: Regulators are now taking action on unsubstantiated claims
Regulators are now taking action on unsubstantiated claims (i.e. evidence gaps) For personal use only https://www.fda.gov/news-events/press-announcements/fda-warns-15-companies-illegally-selling-various-products-containing- cannabidiol-agency-details Emily Miles, Chief Executive of the Food Standard
Slide 6: CBMs supported by evidence are entering mainstream
CBM’s supported by evidence are entering mainstream For personal use only FIRST INDICATION https://www.cnbc.com/2020/01/16/cbd-epilepsy-drug-does-incredible-296-million-in-sales-gw-pharma-ceo.html SECOND INDICATION https://www.americanpharmaceuticalreview.com/1315-News/560474-GW-Greenwich-Bioscience
Slide 7: Real-World Evidence (RWE) accelerates evidence generation
Real-World Evidence (RWE) accelerates evidence generation For personal use only Traditional Model: Market Indication Authorisation Expansion Preclinical Studies Phase 1, 2, 3 Clinical Trials Traditional Post Market Monitoring Real-World Evidence Model: Approval • Primary Approvals RWE - Faster initi
Slide 8: Real-World Evidence (RWE) is already critical for pharma
Real-World Evidence (RWE) is already critical for pharma For personal use only Regulators increasing Big pharma RWE companies acceptance of RWE investing in RWE achieving valuable Major regulators across US, Europe and Canada all exits developing guidance on Real World Evidence to support faster dru
Slide 9: Emerald's evidence generating care model
Emerald’s evidence generating care model For personal use only Emerald’s CLINICAL SERVICE: • Trained multidisciplinary team provides care across Australia (Perth, Sydney, Melbourne and Northern Rivers region of NSW) • Harmonised clinical service ensures consistent care and high quality data • Indepe
Slide 10: Emerald's clinical service boosts RWE quality and value
Emerald’s clinical service boosts RWE quality and value For personal use only High data quality RCT Data EMD RWE • Limited population, controlled environment • Represents “real world” patients with unmet needs – generalisable • Demonstrates safety and efficacy for a specific population • Real world
Slide 11: Careful monitoring of adverse events is critical
Careful monitoring of adverse events is critical For personal use only Insight into when Adverse events are occurring informs prescribing and Emerald’s CLINICAL SERVICE monitoring guidelines • Monitors and manages adverse events Demographics defines at risk populations as part of routine care • Dete
Slide 12: Case Study - Bob
Case Study - Bob For personal use only u Vietnam Veteran injured by large tree fall in 1969 causing multiple fractures u Long-standing chronic back pain, developed peripheral neuropathy thought to be due to exposure to Agent Orange. u Under care of pain specialists using oxycontin, buprenorphine, pr
Slide 13: Emerald's RWE derived from our own clinical service
Emerald’s RWE derived from our own clinical service For personal use only Therapy area Cancer Eye disease + neurology Diverse Initially pain and sleep Delivers clinical service? NO NO NO YES Able to control clinical NO NO NO YES routines Direct input from patient Electronic Medical Records Patient R
Slide 14: Emerald potential revenue streams
Emerald potential revenue streams For personal use only Sponsors pay for Emerald’s Patients Pay for Emerald’s RWE to support: Evidence Generating Care: • Product registrations (unique medical claims) • Clinics approaching cost-neutral • Coverage decisions treatment expense • Drug development EMERALD
Slide 15: Emerald's clinical service
Emerald’s clinical service For personal use only Australian Roll-Out • 4 clinical services operating across Australia • Several new sites under consideration for 2020 London Clinic • Emerald investigating options for a London clinic • LOI with UK partner Data Platform Northern Rivers • Validated ass
Slide 16: Emerald's data service revenue model
Emerald’s data service revenue model For personal use only (2) Data subscription model: Initial • Sponsors subscribe to continuous data on own products and / or specific Approval (1) Initial clinical indications which informs drug development and future trial Engagement: designs • Sponsors purchase
Slide 17: Experienced board with medical focus
Experienced board with medical focus For personal use only Key Person Role Previous Experience >25 years of CEO and Board experience in medical and agrifood biotech companies. Founder of AusCann Ltd (ASX:AC8), medical cannabis manufacturing, Co-founder of Zelda Therapeutics Ltd (ASX:ZLD) medical can
Slide 18: Corporate Snapshot
Corporate Snapshot For personal use only Key Corporate and Financial Data Major Shareholders ASX Code EMD 31% Shares on issue 183.9 M Founders and Management Unlisted Options 18.4M 52% Remaing top 20 Current share price $0.095 Other shareholders 17% Market Capitalisation $17.5M Share price range $0.
Slide 19: Evidence Generating Care
For personal use only Evidence Generating Care www.emeraldclinics.com.au Investor Presentation – March 2020 Michael Winlo – MD & CEO Adam James – COO
Slide 20: Appendix
For personal use only Appendix
Slide 21: The value of RWE case study: Ibrance
The value of RWE case study: Ibrance For personal use only In April 2018, Roche acquired Flatiron for US$1.9B3 Primary 2nd Indication Indication 31/03/18 04/04/19 Clinical Trials (13 years) RWE (1 year) Approval journey for “Ibrance” By using Real-World April-July 2019 sales of (palbociclib) for bre
Slide 22: Recent examples of RWE-driven approvals at FDA
Recent examples of RWE-driven approvals at FDA For personal use only 13 recent FDA efficacy approvals where: Omegaven addresses a highly specialized niche market and has long been available under an expanded FDA used RWE to make a decision on efficacy where: access protocol, making conventional clin
Slide 23: Chronic pain patients in Australia – market size
Chronic pain patients in Australia – market size For personal use only 70% of Emerald’s patients The total cost of chronic pain in present for management of Australia in 2018 was estimated to chronic non-cancer pain be $73.2 billion Pain Australia estimated that The report estimated that chronic pai