Investor Presentation
Released
Released
Announcement PDF
emerald
Company Update – June 2020
Michael Winlo – MD & CEO
Evidence Generating Care
www.emeraldclinics.com.au
Disclaimer and notices
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 purchase securities in Emerald in any jurisdiction. This presentation contains general information only and does not consider the investment objectives,
financial situation and needs of individual investors. Investors should make their own independent assessment of the information in this presentation and obtain their own independent advice from a qualified
financial adviser having regard to their personal objectives, financial situation and needs before taking any action. No representation or warranty, express or implied, is made as to the accuracy, completeness,
reliability or adequacy of any statements, estimates, opinions or other information, or the reasonableness of any assumption or other statement, contained in this presentation. Nor is any representation or
warranty (express or implied) given as to the accuracy, completeness, likelihood of achievement or reasonableness of any forecasts, prospective statements or returns contained in this presentation. Such
forecasts, prospective statements or returns are by their nature subject to significant uncertainties and contingencies, many of which are outside the control of Emerald. To the maximum extent permitted by
law, Emerald and its related bodies corporate, directors, officers, employees, advisers and agents disclaim all liability and responsibility (including without limitation any liability arising from fault or negligence)
for any direct or indirect loss or damage which may arise or be suffered through use or reliance on anything contained in, or omitted from, this presentation. An investment in Emerald securities should be
considered speculative and is subject to investment and other known and unknown risks, some of which are beyond the control of Emerald. Emerald does not guarantee any rate of return or the absolute or
relative investment performance of Emerald securities. The distribution of this presentation including in jurisdictions outside Australia, may be restricted by law. Any person who receives this presentation must
seek advice on and observe any such restrictions.
This release may contain certain forward-looking statements with respect to matters including but not limited to the financial condition, results of operations and business of Emerald and certain of the plans
and objectives of Emerald with respect to these items. These forward-looking statements are not historical facts but rather are based on Emerald’s current expectations, estimates and projections about the
industry in which Emerald operates, and its beliefs and assumptions. Words such as "anticipates," "expects," "intends," "plans," "believes," "seeks," "estimates", "guidance" and similar expressions are intended to
identify forward looking statements and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, particularly those risks or uncertainties inherent in the process
of developing technology and in the endeavour of building a business around such products and services. These statements are not guarantees of future performance and are subject to known and unknown
risks, uncertainties and other factors, some of which are beyond the control of Emerald, are difficult to predict and could cause actual results to differ materially from those expressed or forecasted in the
forward looking statements. Emerald cautions shareholders and prospective shareholders not to place undue reliance on these forward-looking statements, which reflect the view of Emerald only as of the
date of this release. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. Emerald will not undertake any obligation to release
publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this announcement except as required by law or by
any appropriate regulatory authority.
Presentation release authorised by Michael Winlo, CEO and Managing Director
Emerald | Real-world clinical evidence
Emerald is a team of medical doctors, clinical researchers and
data scientists.
We provide data-driven patient care across our network of clinics.
We develop digital health technologies that help generate
accurate and actionable clinical evidence.
Our goal is to translate real-world patient experiences into
evidence-based healthcare and accelerate access to new
treatments in a safe, robust and ethical way.
Funding History & Focus
emd
u Listed on the ASX, 12 February 2020 (ticker: EMD)
u IPO funding $6m |
Last reported cash position (Q1, 2020): $5.018M
|
Market cap: $9.38M (24 Jun 2020)
u Milestones since listing:
u 1000 + patients to 6 months, commercialised data, completed trials, consulting, extended data platform
u Primary focus – commercialising Real World Evidence (RWE) leveraging our clinical and data expertise
Real-World Evidence (RWE) is
becoming more important in
treatment development
Investment highlights
Experienced clinical team delivering a
unique care model
How we create and capture value
Value of the Emerald data platform and
proprietary position
emd
Strong patient and referrer demand
Patient-centric, telehealth-supported
Robust, ethically captured clinical evidence
Unique treatment insights (what works?, for who?)
Capabilities to support care, trials and data insights
Proprietary platform supports development,
validation and commercialisation of new
treatments and technologies
Experienced board with medical focus
Key
Person
Dr Stewart Washer
Dr Michael Winlo
Dr Alistair Vickery
Matt Callahan
Professor Sir John
Tooke
Role
Non-Executive Chairman / Founder
Chief Executive Officer / Managing
Director
Chief Medical Officer / Executive
Director
Non-Executive Director / Founder
Independent Non-Executive Director
emd
Previous Experience
30 years of CEO and Board experience in medical and agrifood biotech companies. Chairman of Orthocell Ltd (ASX:OCC),
regenerative medicine company, Founding Chairman and current Director of Cynata Therapeutics Ltd (ASX:CYP) stem cell
therapies. Founder of AusCann Ltd (ASX:AC8), medical cannabis manufacturing, Co-founder of Zelda Therapeutics Ltd (ASX:ZLD)
medical cannabis clinical studies and research. Stewart has held a number of Board positions in the past, including Chairman
of Hatchtech that was sold in 2015 for A$279m and was a Director of iCeutica Inc. that was sold to a US Pharma. He was also a Senator
with Murdoch University and was a Director of AusBiotech Ltd
Former CEO of rapid growth clinical trial organisation, Linear Clinical Research, serving biotech start-ups through to multinational
pharmaceutical companies across the USA, Europe, Japan and China. Previously, Health Lead at Palantir (a Peter Thiel founded
company based in Silicon Valley) working on complex data integration and analysis for Fortune 50 companies; as well as the US and
UK Governments.
Holds multiple patents in data analysis as well as a Bachelor of Medicine and Bachelor of Surgery (MBBS) and an MBA from
Stanford University Graduate School of Business. Member of AICD and has completed director’s course.
Specialist general practitioner with >30 years’ experience in general practice. Associate Professor of Primary Health Care at the University
of Western Australia and Deputy Chair of the Postgraduate Medical Council of WA and the clinical lead of the research group CHASM
(The Collaborative for Health Care Analysis and Statistical Modelling) - providing high-level analysis and statistical modelling to inform
clinical service evaluation and planning for WA Health. Chair of Black Swan Health, one of the largest primary health care service
providers in WA and Fellow of the Australasian College of Health Service Management and AICD graduate.
Founder of Botanix Pharmaceuticals (ASX:BOT), iCeutica Inc. and Orthocell (ASX:OCC). Successfully developed 4 products through FDA
approval. More than 20 years’ legal, intellectual property and investment management experience. Former investment director for 2
venture capital firms in life sciences and was GM and general counsel with technology and licensing company Ipernica Limited, now
Nearmap Limited (ASX:NEA), where he was responsible for licensing programs that generated more than $120M in revenue.
Senior Independent Director, BUPA Chile, Chair of Collaboration for the Advancement of Sustainable Medical Innovation (CASMI), UCL.
Sir Tooke was Head of the School of Life and Medical Sciences at University College London (UCL) as Vice Provost (Health) and
Academic Director of UCL Partners. Immediate past President of the Academy of Medical Sciences in the UK where he Chaired a report
titled Enhancing the use of scientific evidence to judge the potential benefits and harms of medicine. Previous member of Google
DeepMind Health’s Independent Review Board. Leading advisor to the UK Government regarding health policy and was knighted in the
United Kingdom in the 2007 New Year Honours for Services to Medicine.
Real-world evidence (RWE):
Emerald’s model generates
valuable clinical evidence
during clinical care
Sources of clinical evidence
emd
High data quality
Emerald realworld evidence
Clinical trial data
Low external validity
High external validity
3rd party data
Clinical service data
(eg, claims data)
Low data quality
RWE can shorten treatment development times & costs
emd
Emerald’s Real World Evidence (RWE) care model
emd
u 16 GPs and Specialists
(all GCP-trained)
u Proprietary data
model and system
u In-house data
management,
u 4 locations
around Australia
integration & analysis
Emerald revenue streams
1
3
Clinical care
(patients & health insurers)
Consulting services
emd
2
Clinical trials
4
MAJOR FOCUS:
RWE insights
Development pipeline
Emerald develops digital
health tools that support
RWE generation
Overview of Emerald’s RWE engine
Data Capture
Remote
vital signs &
symptoms
on phone
Clinical
assessment
on patients
attending
Emerald
clinics
emd
Patient Management Programs
3rd party
clinical
databases
(Medical
claims etc)
Medicinal
cannabis
monitoring
COVID 19
safe “back
to work”
Chronic
disease/at
risk
populations
monitoring
Data Management & Analysis
Medrio
Clinical
Database
Patient
Dashboards
Clinical
analysis and
insights
Emerald’s RWE architecture
Data Capture
emd
Patient Management
Real-world outcome data informs
ongoing algorithm development,
research and clinical trials
Data Analysis
Emerald’s RWE programs
EMD
Clinical
Services
emd
Today:
Cannabinoid Management
In development now:
*COVID-19 Monitoring
EMD
Data
Services
*For further details, please see ASX Announcement of 22 June 2020
Potential:
Complex diseases
where evidence is lacking
Real-world evidence for
cannabinoid-based medicines
(CBMs)
Emerald’s cannabinoid medicine RWE asset
emd
CHALLENGE:
u
u
Cannabinoid-based medicines (CMBs) lack high-quality, product-specific, clinical evidence to guide prescribing, registration
and payment coverage decisions
APPROACH:
u
u
Build and deploy a RWE platform within an independent clinical service
u
Capture patient-reported and clinician data
u
Use validated, licenced assessments (the same tools used in clinical trials)
u
Use regulator-grade data standard
u
Work within patients’ usual care teams
u
All patients screened to ensure they had “failed standard of care” and were suitable for treatment
Emerald’s cannabinoid medicine RWE asset
Top indications
• Clinical-trial grade data capture
1
Chronic non-cancer pain
• Licensed and validated clinical assessments
2
Cancer Pain
• We covert all data into standardised models
3
Other Indications
4
Insomnia
5
Neurological Spasticity
6
Parkinson's Disease
7
Migraine (headache)
8
PTSD
9
Epilepsy
10
Chemotherapy induced nausea and
vomiting
11
Alzheimer's Disease
12
Anorexia and wasting due to chronic
illness
13
Dementia
14
Inflammatory Bowel Disease
Histogram of average
CBD dose/day/patient
Histogram of average THC
dose/day/patient
emd
Case Study - Bob
emd
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 with history of PTSD
u
Under care of pain specialists using oxycontin, buprenorphine, pregabalin, gabapentin,
PEA, duloxetine –with little relief and/or poorly tolerated side effects.
u
Now: Stable dose of 15mg 1:1 THC/CBD oil, ceased all opiates, pregabalin and PEA
Scores
BPI Pain severity score
BPI Pain interference score
Visual analogue scale
Insomnia severity score
DASS 42 Depression
DASS 42 Anxiety
DASS 42 Stress
Initial assessment
5.0
5.29
5.0
12.0
14
16
16
Visit 5
1.75
0.86
1.0
1.0
4
2
12
Clinical growth during COVID-19
emd
700
~700
Monthly Appointments
525
470
350
460
341
175
COVID-19 >
0
526
Dec-19
Jan-20
EMD >
Feb 21:
WA
confirms
first case
Feb-20
Feb 12:
EMD IPO
Mar 24:
Nonessential
businesses
close
Mar 10:
Australia
confirms
100th
case
Mar-20
Mar 18: 100%
telehealth
654
(forecast)
May-20
Jun-20
528
Apr 5: WA
closes
borders
Apr-20
Apr 3: EMD offers
COVID monitoring
May 11: EMD
selected to lead
national COVID data
research project*
*For further details, please see ASX Announcement of 11 May 2020, at present, EMD has not yet commenced monitoring vaccine participants
Jun 17: EMD
selected to monitor
150 COVID vaccine
trial participants*
Fighting COVID-19
with Real-World
Evidence
Why do we need better COVID-19 monitoring?
emd
u COVID-19 is here to stay as a global pandemic
u Social distancing may be necessary into 2022 in the US 1
u Development of a vaccine is by no means certain
u 100+ vaccine candidates entering trials 2 however, no coronavirus vaccines have been
developed before and the upper respiratory tract is a difficult target
u Testing & tracing is problematic
u Sensitivity and specificity can vary greatly leading to false positives and false negatives 3
u Viral genome may be detected up to 28 days from symptom resolution further complicating
testing and quarantine practices due to positive test results 4
u Development of a treatment is by no means certain
u Drug repurposing studies underway focused on reducing severity of disease 5,6
u Unknown long-term health impacts of infection
u Early data suggests post recovery negative impact on lungs, heart, stroke risk, neurological
dysfunction, inflammatory responses. 7,8
https://www.nytimes.com/interactive/2020/us/
coronavirus-us-cases.html (June 24th, 2020)
u An unqualified perception of risk is the biggest threat to businesses and educational
establishments and hence economic recovery 9,10
1. Projecting the transmission dynamics of SARS-CoV-2 through the postpandemic period by Stephen M. Kissler et al.
Published online in Science : 14 APR 2020 Link
2. World Health Organisation Draft landscape of COVID 19 candidate vaccines Link
3.Correlation of Chest CT and RT-PCR Testing in Coronavirus Disease 2019 (COVID-19) in China: A Report of 1014 Cases Link
4. Humoral immune response and prolonged PCR positivity in a cohort of 1343
SARS-CoV 2 patients in the New York City region Link
5. World Health Organisation International Clinical Trials Registry Platform Link
6.
US listed Clinical Trials Link
7.Potential Effects of Coronaviruses on the Cardiovascular System A Review Link
8.Neurologic Features in Severe SARS-CoV-2 Infection Link
9.How Employees Feel About Coronavirus Now: A PandemicEX Survey Update Link
10.Qantas workers fear virus safety: survey Link
The Emerald approach
• A clinician-led monitoring service:
• Our extended RWE platform can now help
monitor symptoms and vital signs using just a
smartphone
• Intelligent alerts help identify patients requiring
further clinical review by our clinical team
• Our team of trained GPs and specialists provide
clinical evaluation and review, as required
< Representative data only >
NOTE: EMD has commenced vital signs monitoring
generally, but has not commenced vital signs monitoring
for the sole purpose of COVID-19 monitoring, nor has it
received revenues in respect of vital signs monitoring for
the purposes of identifying COVID-19.
What’s ahead
emd
u Cannabinoid medicine RWE:
u Ongoing commercialisation of RWE
u Clinical trials
u Expansion into UK
u COVID-19 Opportunities:
u Clinical monitoring - COVID-19 Vaccine trial (150 participants, 2 years)
u A tool to assist organisations to get “back to business” with a clinician-guided COVID-19 monitoring service
emerald
Company Contacts
Media Enquires - media@emeraldclinics.com.au
Investor Enquires - investors@emeraldclinics.com.au
Partnership Enquiries - evidencepartners@emeraldclinics.com.au
Patient Enquiries - patients@emeraldclinics.com.au
Evidence Generating Care
www.emeraldclinics.com.au
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