Truscreen Presentation
October 2020
NZX:TRU
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Our screening solution is ideal for communities that can’t access
conventional laboratory-enabled screening methods. It is affordable and
easy to learn. Our purpose is to ensure that all women of screening age –
no matter who or where they are –can have access to quality screening.
Company Overview
⚫NZX listed, ASX dual listing is in process to be finalized in 2020
⚫Medical device company, specialising in the development, and commercialisation of the TruScreen cervical cancer
screening device
⚫Commercial focus on low and-middle income countries (LMICs) with a higher burden of disease, and no centralised or
organised cervical cancer screening guidelines/programs
⚫TruScreen is sold via local distribution networks in our target markets, with commercial sales in China, Russia, Mexico
and Vietnam.
⚫NMPA (China, formerly CFDA) and CE mark certified as primary cervical cancer screening tool
⚫Extensive clinical validation over a 10 year period, with recognition by the World Health Organisation (WHO)
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TruScreen is a real-time, AI supported,
objective screening device that detects the
presence of pre-cancerous and cancerous
tissue of the cervix.
►A Single Use Sensor (SUS) is used for each exam
►TruScreen uses optical and electrical
measurements to detect cellular changes of the
cervix
►AI supported algorithm analyses patient’s
measurements to determine if cervical tissue is
normal or abnormal
►Immediate result provided at point of screening
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Single Use Sensor
(SUS)
TruScreen Handheld
Device (HHD)
Intelligent Cradle
(IC)
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The World Health
Organisation (WHO)
has set a target to
eliminate cervical
cancer
by the end of the
century.
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90% coverage of HPV
Vaccination of girls
(by 15 years of age);
70% coverage of
screening* and 90%
treatment of precancerous
lesions;
Management of 90% of
invasive cancer cases
*70% of women screened with high performance tests by the ages of 35 and 45 years
►LMICs –lowest screening rates, highest incidence and
mortality rates
►Innovative service delivery models are required if
LMICs are to meet WHO screening targets
►TruScreen’s disruptive model offer:
●Not reliant on laboratory infrastructure
●Non-invasive
●Accurate, real-time screening
●Easy to train and learn
●Affordable
►TruScreen has presence in many of these markets,
and the support of Key Opinion Leaders, NGOs, and
government organisations
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TRUSCREEN
Patients
▪Real-time results
▪Painless & non-
invasive
▪Single visit required
Clinics
▪Objective results
▪Minimal training
▪Cost effective
▪Single visit
▪Portable
Technology
▪No laboratory required
▪User friendly
▪Accurate results
PAP Test
Patients
▪Requires repeat visits
▪Delay in results and
treatment
▪Scraping of the cervix
results in patient
discomfort
Clinics
▪Subject to human error
▪Labour intensive
▪Delay in results
Technology
▪Dependant on lab
▪Requires highly trained
cytologists
▪Accuracy varies greatly
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Women eligible for
screening in key markets
1bn+
In millions
TruScreen’s
current markets
Targeting
commercial roll-out
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Africa
Mexico
Vietnam
Russia
Eastern Europe
India
China
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42
17
318
402
*Screening population data based on U.S Central Intelligence Agency (CIA) World Factbook, women aged 25-64.
Disruptive technology,
high potential
►Real-time, single visit,
mobile screening
technology
►No lab infrastructure
required; nurse/clinician
administered
►Recognised by WHO,
UNITAID, and the
Clinton Health Access
Initiative (CHAI)
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Compelling commercial
model
►Targeting LMIC markets
with no organised or
centralised cervical
screening programs
►Lean distributor-based
model
►Annuity revenue stream
►SUS revenue will grow
at a higher rate
thanDevicerevenue
►SUSrevenue becomes
a sustainable, recurring
revenue stream
Clinical and commercial
validation
►Sensitivity and specificity
equal to, or greater than,
alternative screening
tools
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►Clinically validated on
over 30,000 women
across multiple countries
►Established user base
and KOL support in key
markets
Poised for Growth
►Ramping up in existing
markets to deliver sales
growth amid COVID19
impact
►New markets (Central
Europe, Vietnam)
coming on board
►Manufacturing process
enhancements to deliver
double-digit margin
improvement
The real-time, AI enabled, cervical cancer screening method
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2014 Nov
Listing on NZAX
2021-2022
ASX Listing
Strengthen the team
Recovery COVID-19
Margin improvement
Further roll-out and manufacture in China
Setting commercial roll-out in Vietnam and India
2018 Oct
523% sales
growth in H1
2019 May
Recognition by
World Health
Organization
CFDA (NMPA)
approval for second
generation device
2017 Dec
Commence large scale
pilot programs in China
with CDC and COGA
2018 Jul
Migration to NZX
2018 Dec
2019 Sep
China COGA study
1st province
screening results
exceed
expectations
Setting the fundamentals 2014 – 2020
Transformation
2021 – 2022
Rapid Growth
2023 & beyond
Rapid non-linear sales growth
Company growth to support the sales
Strategic partnerships
* Subject to covid-19 and geopolitical situation
China COGA 2
nd
province study
results exceed
expectations
2020 Sep
Drive adoption in
established markets and
new markets
►Continue roll-out in more
established markets
(China, Russia,
Zimbabwe)
►Drive adoption in
Vietnam and resume roll-
out in India subject to
covid-19 restrictions
►Seed in promising LMIC
markets (Eastern
Europe)
Relentless focus on
product quality and
innovation
►Upgrade Quality
Assurance (QA) systems
►Ongoing improvement of
device in line with
feedback from markets
►Innovative approaches to
communication with
customers and doctors,
re-branding
Expanding clinical
support
►New clinical publications
under MAC supervision
►Continue local trials to
ensure local KOL support
►Launch online education
module with certification
to prepare the company
for rapid expansion
Enhance team
capabilities
►Hiring of high profile
executives with expertise
in medical devices/LMIC
markets
►Leverage digital solutions
for QA, training &
education, sales support
►Grow the team in line
with sales progress &
business needs
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TruScreen’s biggest market with a growing sales
trend, and huge potential
The Opportunity:
●404mwomen of screening age
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●No centralised screening programs or guidelines
●TruScreen’s most established market, initial distribution
agreement signed 2014
2020 Market Progress:
●FY20 SUS sales volume increased 38%, despite COVID-19
lockdown since Jan 2020
●Expanded distribution network covering all major areas
●Continued with a large clinical study with COGA
Pipeline*:
●COGA consensus of TruScreen in cervical cancer screening
●Over 100 public tier 1 & 2 hospitals in sales pipeline
●Local device assembly
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* Subject to cvoid-19 conditions and geopolitical situation.
Early commercialisation stage, focus on clinical
education and KOL engagement
The Opportunity:
●42m women of screening age
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●No centralised screening program or guidelines
2020 Market Progress:
●New distributor established in early 2019
●TruScreen conducted a clinical & technical training
programs with distributor and KOL
●Established a local service centre
●Sales in line with agreement
●KOL endorsement
Pipeline*:
●Major clinical validation study
●Targeting inclusion at the primary screening tool in national
guidelines
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* Subject to cvoid-19 conditions and geopolitical situation.
Early stage commercialisation, focus on public
hospital rollout
The Opportunity:
●24m women of screening age
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●No centralised screening programs
2020 Market Progress:
●Extensive clinical training for KOL
●Completed MOH clinical validation project in Hanoi Obstetrics
and Gynaecology Hospital (HOGH)
●Granted MOH approval for use as a primary screening tool
●First commercial installations and usage to commence in
HOGH hospital;
Pipeline*:
●Further MOH supported rollouts in public and private
hospitals as primary screening tool
●Doctor & KOL education project in key hospitals
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* Subject to cvoid-19 conditions and geopolitical situation.
Key Variances
⚫Sales down 31% to NZ$1.3m, from Chinese
procurement delays and initial COVID-19
⚫Total revenue down 18% to NZ$2.55m
⚫EBITDA improvement of 23% YOY with reduction
in overhead costs
⚫China remains primary focus, recent entry into
Vietnam
⚫Improvement in operating cash outflow
⚫Successful capital raise of NZ$5.243m early in the
new year
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KEY FINANCIALS
NZD (m)
FY 18
Actual
FY 19
Actual
FY 20
Actual
% Change
FY20/FY19
Sales0.81.91.3-31%
Total Revenue2.23.12.5-18%
COGS.741.40.8
R&D1.91.71.1
EBITDA(3.6)(2.8)(2.1)+23%
Net Assets*11.611.37.2
Cash1.21.71.0
*Net assets in 2020 reflects a $2.4m write down of intangible assets.
►Progressed in commercial roll-out with key clinical trials finalised in China, India and Vietnam
►Main market continues to be China accounting for over 60% of sales
►Initial results from COGA trial in China in 2 provinces surpassed expectations (better or equal to LBC and
hrHPVin the same study)
►Service centres established in China, Russia, Vietnam and Mexico
►TruScreen cervical cancer screening device acknowledged in Unitaid/WHO report in May 2019 on
screening and treatment technologies and advantages of use in low and middle-income countries
►New CEO appointed as of 2nd March
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FY2021 Year to Date (YTD) Highlights
►Sales YTD +69% vs. last year, NZD (April-Aug’19 to April-Aug’20, unaudited)
►Sales of SUS +79% YTD vs last year, units (April-Aug’19 to April-Aug’20, unaudited)
►Milestone of 100 installed devices achieved (devices that are used for screening in key countries)
►Approval from Vietnamese Ministry of Health and commercial roll-out in major Hanoi hospital
►Further progress with COGA with 2
nd
province initial trial results exceeding expectations
►Further progress with clinical educational program in Russia
►Appointment of a specialized medical device distributor for Eastern Europe (Aspironix) to cover 3
countries: Czech, Slovak and Poland (17m screening population)
►Updated branding and visual identity rolled out
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March’19
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March’20
June’20
May’20
July’20
March’21
81
88
90
100
160
* Excluding Mexico. Subject to covid-19 conditions and geopolitical situation.
⚫Continue to focus on commercial roll-out in key markets
⚫Achieve >160 commercially installed devices across key markets (+100% YoY)
⚫Obtain COGA consensus in China on TruScreen as primary cervical cancer screening tool
⚫Continue with HCP education program in Russia, increase commercial coverage
⚫Commercial roll-out in Vietnam and Zimbabwe
⚫Start planning commercial roll-out in India once covid-19 restrictions are lifted
⚫Expand market our presence in Eastern Europe
⚫Enhance team capabilities in Technology and Medical Affairs
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* Subject to covid-19 conditions and geopolitical situation.
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Victoria Potarina
Chief Executive Officer
M –+61 450 455 221
E –victoriapotarina@truscreen.com
TruScreen
36 Bradfield Road, CSIRO
Lindfield West NSW 2070
Australia
www.truscreen.com
Guy Robertson
Chief Financial Officer
M –+61 407 983 270
E –guyrobertson@truscreen.com
TruScreen
36 Bradfield Road, CSIRO
Lindfield West NSW 2070
Australia
www.truscreen.com
Appendix
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With over 100 years combined medical device experience
CEO
Victoria Potarina
►Over 20 years commercial experience
►Previously worked at Johnson &
Johnson across UK and Europe
►Held positions at multiple multinational
companies in FMCG, over-the-counter,
medical devices, and healthcare sectors
CFO
Guy Robertson
►Chartered accountant with 30
year financial management &
leadership experience
►Company Secretary for
TruScreen Group Ltd
CTO
Edmond Capcelea
►Over 20 years experience in
medical device design &
development
►Leads the technical department,
and steers TruScreen’s Research &
Development
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With over 100 years combined medical device experience
Medical Affairs
Beata Edling
►MD, PhD, MBA qualified
►Proven track record in medical
affairs, market access and product
launch in both start-ups and
multinational corporations
GM -Commercial
Dr. Jerry Tan
►Qualified gynaecologist
►Extensive experience in
China, and East Asia
►Oversees distributors, market
evaluation, and clinical trials
GM –Quality & Reg Affairs
Paul Curran
►Expert in healthcare compliance
including medical device
licensing and quality assurance
►Responsible for product
registrations, and quality
assurance
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Chairman
Tony Ho
►Non-executive chairman of
Greenland Minerals
(ASX:GGG), and Bioxyne
(ASX:BXN)
►Chairman of Cannasouth
Limited (NZX:CBD)
►Past NED of Hastings
Technology Metals (ASX:HAS),
and Brazin (ASX:BRZ)
Non-Executive Director
Chris Horn
►Chair of Audit, Finance, and
Risk Committee
►20 years as partner of
KPMG and it’s predecessor
firms.
Non-Executive Director
Chris Lawrence
►Experiences life science
and biotech investor
►Strong experience in high
growth companies,
particularly in biotech sector
Non-Executive Director
Juliet Hull
►20 years experience in
healthcare sales, marketing,
and leadership
►NZ GM/Country director for
Johnson & Johnson Medical
►Director of the ANZ J&J
Medical Executive Board, and
Medical Technology
Association of NZ (MTANZ)
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Colonel (Dr.) Michael J. Campion
•Colonel (Dr.) Michael J. Campion isa Senior Staff
Specialist and Headof the Pre-Invasive Clinic at
the Gynaecological Cancer Centre of the Royal
Hospital for Women in Sydney and is a Conjoint
Associate Professor, School of Women’s and
Children’s Health, at the University of New South
Wales.He has over 30 years’ experience as a
qualified medical practitioner and over 20 years of
experience as an expert colposcopist.
•Director, Health Services Army Reserve –Eastern
Regionfor the Royal Australian Army Medical
Corps andis both a Board member andNational
Hospitaller, St John Ambulance, Australia.Dr.
Campion has written numerous peer
reviewedpapers and chapters on cervical cancer,
including papers on TruScreen.
Chairman -RAAMC, CStJ, KM, KCHS, KLJ
Professor Neville Hacker AM
•Professor Neville Hacker is conjoint Professor
of Gynaecological Oncology at the University
of New South Wales and recently retired from
clinical practice after 32 years as the director
of the Gynaecological Cancer Centre, Royal
Hospital for Women in Sydney, where he
continues to serve as an Emeritus Consultant.
•Past President of the Society of Pelvic
Surgeons. He is a past President of the
International Gynaecological Cancer Society,
former Chairman of the Oncology Committee
of the RANZCOG, and a former Chairman of
Examiners for Gynaecologic Oncology,
RANZCOG.
Clinical Advisory -Professor of Gynaecological
Oncology
NZX:TRU Share Price History
6 Month Data, as at 23 October 2020
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Significant Shareholders
Consolidated Nominees11.9%
NZ Depository Nominee8.2%
Browns Island Holdings Ltd6.7%
Waitara Trustees Limited5.6%
NZ Central Securities7.05%
Market CapNZ $30.25M (as at 23 Oct 2020)
Share PriceNZ $0.091 (as at 23 Oct 2020)
Cash PositionNZ $3.5M (as at 20 Oct 2020)
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