Investor Update
Investor
Presentation
March 2019
(NZX:TRU)
INVESTMENT SUMMARY
Only device of its type –CE Mark
approved for primary screening
Commercial stage cervical cancer
screening technology
Clinically-validated &
well-positioned for developing
nations
Significant opportunity in
developing nations:
NZD 166M addressable market p.a.
2
At TruScreenwe are building our device, experiencing sales momentum in key markets through a
global distribution model and growing year on year.
To provide primary screening for
cervical cancer in developing
nations via the TruScreen device
–the latest single-visit, real time
screening technology solution.
TRUSCREEN’S MISSION
3
CERVICAL CANCER AROUND THE WORLD
AFRICA
226M
INDIA
302M
MEXICO
31M
Fourth most
common cancer
worldwide
LATIN
AMERICA
120M
RUSSIA
44M
CHINA
401M
Screening age population
1BN+ women of
screening age in
developing
nations
Developing
nations:
85% of cases
90% of deaths
occur in
developing
nations
Ref: Based on U.S Central Intelligence Agency (CIA) World Factbook
MIDDLE
EAST
70M
4
CERVICAL CANCER IS A MAJOR PUBLIC HEALTH ISSUE
•Current vaccine programs only cover HPV
types that cause 70% of cervical cancer
•Some countries scaling back HPV vaccines
(e.g. Japan)
•At least 80 years away from cervical cancer
elimination
•Screening guidelines: every 2-5 years
•85% of cervical cancer cases
•Do not have HPV vaccination programs
•No or minimal screening programs
•Limited labinfrastructure
•Limited diagnostictechnicians
DEVELOPING NATIONS
DEVELOPED NATIONS
Better screening solutions for cervical cancer are needed in developing nations.
TruScreen fulfils this market need.
5
HOW IT WORKS
•Low electrical charge and light examines the cervix’s surface
•Uses algorithm to determine if cervix tissue is normal or
abnormal
TRUSCREEN VS OTHER SCREENING METHODS
Patients
Painless
Non-Invasive
Real-time results
Clinics
Objective readings
Minimal training
Cost effective
Single visit
Portable
Patients
Repeat visit
Scraping ofcervix
Clinics
Widely varying accuracy
Human error
Labour intensive
Long wait times
(days/weeks/months)
Technology
Vaccinesdon’t cover all HPV
types
Technology
User-friendly
Accurate readings
TRUSCREEN
OTHER
Charging station
TruScreen
Device
Single Use Sensor
(SUS)
6
COMMERCIAL STRATEGY
•Lack lab infrastructure
•High prevalence ofHPV &
cervical cancer
•Governments investing in
women’s health
•Market need for portable,
accurate screening
technology
Build awareness
•Key Opinion Leaders
engagement
•Medical conferences
•Clinical trials/studies
Strong sales momentum
•Sales H1 FY 19 > Total Sales
FY18
•Annuity revenue with SUS
reorders
Global distribution
•31 countries
•Pilot public healthinitiatives
in key markets
Research and Development
•Second generation device in
market
TARGETING DEVELOPING
NATIONS
MARKET ENTRY &
DEVELOPMENT
SUCCESS SO FAR
Expand footprint
•Local distributorstrategy
•Public health initiatives
•Partnerships with Non-
Government Organisations and
Government agencies
Technology transfer to key
markets
1
Based on SUS sales x screening age population
7
BUSINESS MODEL
•NZD 166M
addressable market
p.a.
1
•Sale of SUS =
sustainable annuity
revenue
Truscreen’slocal
distributors target:
•Public hospitals
•Private hospitals
•Public health
initiatives
•Governments
•Non-Government
Organisations
TruScreen device
Single Use Sensors (SUS)
TRUSCREEN
END CUSTOMERS
1
Based on TruScreenachieving 5 per cent market share of developing markets’ cervical cancer screening age population screened once every three years
8
COMMERCIALISATION JOURNEY AND MILESTONES
2018 -Dec
Migration to NZX
2018 -Jul
Commence
large scale pilot
with China CDC
and COGA
2018 -Oct
523%sales
growth in H1
2018 -Aug
HIV African
Initiative
2018 -Jul
New Australian
production facility
fully operational
2017 -Dec
CFDA approval for
second generation
device
2017 -Mar
Gained Indian
market
2015 -Sep
Approval for
Mexico market
2019 –Feb
New distribution
agreement in
Russia
2014 -Nov
Listing on NZAX
2016 -Apr
CE Mark for second
generation device
9
World’s biggest
cervical cancer market
(Screening age population: 400M)
71%
of TruScreensales
Initial distribution agreement
signed 2014
KEY MARKET: CHINA
Screening programs
•Various programs run by Central, State and Municipal governments, plus charities and major
state owned enterprises (e.g. Sinopec)
Market presence
•CDC (Centre for Disease Control) –20,000 women in pilot program –report due 2019
•COGA (Chinese Obstetricians & Gynaecologists Association) –screen 20,000 women in
public hospitals. Commenced Nov 2018, completion in 2020
•Xinjiang province -Western China (190 hospitals)
•Hospital usage of SUS: 150/m, with some using 1,000/m
Pipeline
•KOL support from COGA
•CDC program: Adoption in 3,000 women and children’s hospitals
•COGA program: Open up 200 public hospitals in 2019
•Xinjiang: 100 devices in 2019 and 190 in 2020 for government screening program -up to 2M
women every two years
•Installation in 50 ‘Breast and Cervical Cancer Centres’ in rural areas in 2019
•‘Medical Checkup’ centres -target at least 50 in 2019, and then expand
FACTS
10
KEY MARKET: MEXICO
Screening programs
•Split between Central Govt and State Health Secretariats, public Insurance agencies (ISSTE and
IMES), armed forces and state owned monopolies –e.g. Pemex
•New central government is conducting an overhaul of the National Health administration and
TruScreen will adjust its plans to suit
Market presence
•Installed in National Cancer Institute
•Installed in ‘Health Train’, ISSTE, Pemex and state-owned hospitals
Pipeline
•Central and State Government Health Secretariats
•National health insurer, ISSSTE -500,000 pap tests p.a. (installed in 4 ISSTE hospitals)
•National oil monopoly, PEMEX -60,000 pap tests p.a. (installed in 2 Pemex hospitals)
•Private lab and clinic chains
31M
women of screening age
12%
of TruScreensales
Initial distribution agreement
signed 2015
FACTS
11
KEY MARKET: AFRICA
Screening programs
•Step 1: National Aids Council of Zimbabwe
•Step 2: Use this for both government and NGO support for other projects in East Africa –
Malawi and Mozambique submission being prepared
•Collaborating with DYSIS Medical and WISAP Medical Technology GmbH
Market presence
•TruScreen selected Zimbabwe NAC program for AIDS affected women
•Ministry of Health supported aid application to use TruScreen for a national screening
program
Pipeline
•Evaluated by National Aids Council of Zimbabwe
•Target East and Southern African countries with high HIV prevalence
FACTS
227M
women of screening age
13.1M
women suffer from HIV
HIV+ women up to
x5
increased
risk of developing cervical cancer
12
KEY MARKET: RUSSIA
Screening programs
•No central government screening programs
•State and municipal governments conduct ad hoc programs
Market presence
•Distribution agreement with IMSystemswith initial orders in Feb 2019
•Advanced payment of USD $250k
Pipeline
•Evaluated by ROSZDRAVNADZOR (Russia FDA)
•Major target is State Government Health Systems, starting with St Petersburg
•Private clinics and hospitals
44M
women of screening age
Initial agreement in 2015
New agreement distribution
agreement signed in Feb 2019
FACTS
13
KEY MARKET: INDIA
Screening
•Split between Central Govt and State Health agencies and govt institutions –Armed Forces,
State Rail et al.
•Central government has mandated that all women over 25 be screened for breast and cervical
cancer
Market presence
•Engaged major distributor (KLAB) –700 employees
•Commenced marketing in four states –Delhi NCR, Madhya Pradesh, Haryana and Maharashtra
Pipeline
•All India Institute of Medical Science (AIIMS)
•Central and state governments (aim for inclusion in the 2019 National Ministry of Health
Budget)
•Armed Forces Hospitals and Armed Forces Medical Research Centre
•Major Private Hospital Groups (e.gFortis, Apollo)
300M
women of screening age
Initial distribution agreement
signed 2017
Sales commenced in FY18
FACTS
14
Current Capacity
•Established EOA (Electrical Optical Assembly)
manufacturing facility at CSIRO
•Current capacity: 100 units/month
•Can be doubled in short time
•R&D tax offset
Future capacity
•Up to 200 units/month
•~50% improvement in gross profit per device
•Cost reduction initiatives:
•Bring high tech processes in-house
•Technology transfer to key markets –‘local device’ for
domestic registration
MANUFACTURING
15
CORPORATE AND FINANCIAL OVERVIEW
Sales growth
175%
Snapshot
(YOY growth -against March 2019 estimate)
TruScreen distributor
network
31
countries
SUS sold
150,000
TruScreendevices
sold
268
TRUSCREEN OVERVIEW (NZD)
Market cap$34.M
Share price$0.16(28 February 2019)
Cash position$1.3M(as at 28 February 2019)
Significant
shareholders
Directors and management hold 28.9%
Consolidated Nominees 13.62%
Browns Island Holdings Ltd 9.22%
WaitaraTrustees Limited 7.67%
16
KEY FINANCIALS
NZD (millions)
FY19
Forecast
FY18
Actual
FY17
Actual
FY16
Actual
% Change
FY19/FY18
Revenue3.02.21.41.8+36%
Sales2.20.80.60.5+175%
EBITDA(3.1)(3.6)(3.0)(1.3)+14%
Net Assets11.011.614.314.1-
Cash and Cash
Equivalents
1.21.23.72.3-
FINANCIAL DATA
17
EXPERIENCED EXECUTIVE TEAM
•Founding CEO of TruScreen since initial
commercialisation
•12 years in sales and marketing of
women’s health products
•Chartered accountant with 30 years
financial management and leadership
experience
•Company Secretary for TruScreen
•Qualified gynaecologist
•Extensive experience in China, and
East Asia
•Oversees distributors, market
evaluation and clinical trials
MARTIN DILLON
CEO
GUY ROBERTSON
CFO
DR JERRY TAN
GM INTERNATIONAL
BUSINESS
DEVELOPMENT
Executive team supported by a
team of 7 key personnel with
significant scientific and
engineering experience.
Medical Advisory Board
Experts in gynaecologyand
vulvovaginal disease
Board of Directors with
extensive commercial
experience
18
Market development
Deepen market penetration via:
Endorsement from Key Opinion Leaders
Government adoption
Major screening programmes
Build funding organisation support for TruScreen
programmes
Enhance distribution networks
Manufacturing
Expand capability
SUS manufacturing technology transfer
Build annuity revenues
Transition early adopters to commercial users
Further regulatory approvals and clinical trials
UPCOMING MILESTONES
19
FY18 Goals and Strategic Progress
Tony HoMartin DillonGuy Robertson
ChairmanChief Executive OfficerChief Financial Officer
Investor relations enquiries: truscreen@we-buchan.com
CONTACT
www.TruScreen.com
20
FY18 Goals and Strategic Progress
APPENDIX
21
BOARD OF DIRECTORS WITH EXTENSIVE EXPERIENCE
Robert Hunter –NED
•35 years commercial experience
•Past Director and/or Chairman of public and
private companies, including in biotechnology
and funds management sector
Christopher Horn –NED
•Chair of Audit, Finance and Risk
Committee
•20 years as a partner of KPMG and its
predecessor firms.
Prof Ronald William Jones CNZM –NED
•Member of Medical Advisory Board
•Experienced obstetrician and gynaecologist
•International authority of lower genital tract
pre-cancer and cancer
Chris Lawrence –NED
•Experienced life science and biotech investor
•Strong experience in high growth companies,
particularly in biotech sector
Con Hickey –NED
•Member of Audit, Finance and Risk
Committee
•Senior healthcare executive with 30+ years
experience in international and medical
device businesses
Tony Ho –Chairman
•Non-executive chairman of Greenland Minerals
(ASX: GGG) and Bioxyne(ASX:BXN)
•NED and Chairman of the audit committee of
Credit Intelligence (ASX:CI1)
•Past NED of Hastings Technology Metals (ASX:HAS)
and Brazin(ASX:BRZ)
22
EXPERIENCED MEDICAL ADVISORY BOARD
Professor Neville Hacker AM –Chairman
Clinical Advisory -Professor of
Gynaecology
Professor Hacker is the director of the
Gynaecological Cancer Centre, Royal
Hospital for Women in Sydney and
Professor of Gynaecological Oncology at
theUniversityofNewSouthWales.
He is a past President of the Society of
PelvicSurgeons.HeisapastPresidentof
the International Gynaecological Cancer
Society, former Chairman of the
Oncology Committee of the RANZCOG,
and a former Chairman of Examiners for
GynaecologicOncology,RANZCOG.
Professor Ronald William Jones CNZM
MB ChB, MD (Otago), FRCS(Ed), FRCOG,
FRANZCOG, FAOFOG(Hon)
ProfessorRonJonesisaNewZealandmedical
graduate. Following 6 years postgraduate
training in England he returned to the
NationalWomen’sHospitalinAuckland,New
Zealand where he was a Visiting Consultant
Obstetrician&Gynaecologistfor38yearsand
latterly a Clinical Professor at the University
ofAuckland.
He has published extensively in the field of
lower genital tract pre-malignancy and
has lectured in over 30 countries. Professor
Jones is a past President of the International
Societyforthe StudyofVulvovaginal Disease
and a past Chairman of the Scientific
CommitteeoftheInternationalFederationof
CervicalPathologyandColposcopy.
Colonel (Dr.) Michael J. Campion
RAAMC, CStJ, KM, KCHS, KLJ
Colonel (Dr.) Michael J. Campion is a Senior
Staff Specialist and Head of the Pre Invasive
Clinic at the Gynaecological Cancer Centre of
theRoyalHospitalforWomeninSydneyandis
a Conjoint Associate Professor, School of
Women’s and Children’s Health, at the
UniversityofNewSouthWales. Hehasover30
years’ experience as a qualified medical
practitionerandover20yearsofexperienceas
anexpertcolposcopist.
Inaddition,Dr.CampionistheDirector,Health
ServicesArmyReserve–EasternRegionforthe
Royal Australian Army Medical Corps and is
bothaBoardmemberandNationalHospitaller,
StJohnAmbulance,Australia. Dr.Campionhas
written numerous peer reviewed papers and
chapters on cervical cancer, including papers
onTruScreen.
23
TRUSCREEN PERFORMANCE
Interim results RHW (2017): Excellent. 93% Negative Predictive Value
Interimresults 6 teaching hospitals in China (2018): T1 Sensitivity: 90.4%; Specificity: 75.3%
TruScreen1 at Guadalajara (2016) Sensitivity to CIN2+ 78%Specificity 64%
TruScreen1 at Singer et al (2003) Sensitivity to CIN2+ 70%Specificity 80%
TruScreen1 atLi Xia et al in China
(2011)
Sensitivity to CIN2+ 81.7%Specificity 79.6%
TruScreen1at Guangdong China
(2010)
Sensitivity to CIN2+ 78.8%Specificity 74.4%
TruScreen1 in Shandong China
(2010)
Sensitivity to CIN2+ 75%Specificity 85%
CLINIC DATA
PAP and HPV in TruScreen’smarkets –Sensitivity to CIN2+
Guadalajara (2016)HPV DNA 56%PAP 36%
TruScreen1in Hainan China (2011)PAP 71.3%
TruScreen1at Guangdong China
(2010)
PAP 42.2%
TruScreen1 in Shandong China
(2010)
PAP 43%
24
INTELLECTUAL PROPERTY
•TruScreenuses trade secrets to ensure protection against IP
infringement
•Enumerated in the appendices to the Marrakesh Agreement which
established the World Trade Organisation
IP coverage:
•Electro Optical Assembly
•Firmware
•Circuit Design and Printed Wire Assemblies (electronics)
•Single Use Sensor
•Algorithm
•Trademarks
•All testing protocol and manufacturing specifications
•China:
•Patent -Apparatus for Tissue Recognition Using Multiple
Measurement (ZL201210439914.9)
•Trademarks for “TruScreen” and “SUS” (English and Chinese
equivalent)
25
Disclaimers
This presentation should be viewed in conjunction with TruScreen’sFinancial Statements for the 12 months to 31 March 2018 and the accompanying NZX release.
The information presented is a snapshot and does not contain supporting information necessary to make an investment decision. It is not intended to act as a
recommendation to acquire TruScreen shares. There can be no assurancethat actual outcomes will notmaterially differ from the forward looking statements presented.
A number of important factors could cause actual results or performance to differ materially fromthe forward-looking statements. The forward-looking statements are
based on information available to TruScreen as at thedateof this presentation. Except as requiredby law (including the NZAX Listing Rules), TruScreen undertakes no
obligation to provide any additional or updated information whether as a result of new information, future events or results or otherwise. TruScreen, its advisers,
affiliates, related bodiescorporate, directors, officers,partners, employees and agents make no representation or warranty, express or implied, as to thecurrency, accuracy,
reliabilityor completeness ofinformation in this presentation.
26
Data sourced from publicly available filings. Our datasets may not be complete. Automated analysis can produce errors. If you believe any data on this page is incorrect, please contact us at hello@nzxplorer.co.nz. For informational purposes only. Not investment advice.