TruScreen Annual Meeting – Shareholder Presentation

NZX and Media Release 27 September 2017
NZX Limited
WELLINGTON
TruScreen Annual Meeting
Chairman’s Presentation

TruScreen Limited (NZAX: TRU), advises that its Annual Meeting will be held at Link Market Services,
Level 11, Deloitte Centre, 80 Queen Street Auckland, 1010, at 2.00pm today.
Please find attached a copy of the Chairman’s presentation to shareholders.

For more information visit www.truscreen.com


Contact
Martin Dillon
TruScreen Chief Executive Officer
Email: martindillon@truscreen.com

-ENDS-

About TruScreen:
TruScreen’s real time cervical cancer technology
utilises a digital wand which is placed on the
surface of the cervix to measure electrical and
optical signals from the surrounding tissue. A
sophisticated proprietary algorithm framework
distinguishes between normal and abnormal
(cancerous and precancerous) tissue to identify
precancerous change, or cervical intraepithelial
neoplasia (CIN). A Single Use Sensor (SUS) is used
for each patient to protect against cross-infection.

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Shareholder
Presentation
Annual
Meeting
2018

•Strong sales growth of 2
nd
Gen TruScreento China commenced during 4
th
quarter. (50% of the year’s sales were generated in the fourth
quarter)
•Completed the testing and validation in February 2018 of its second-generation device including in market clinical trials where impressive
results were obtained.
•Expanded its global sales and distribution network into Africa, Latin America and India (covering a combined screening population of
approx. 1 billion women)
•Obtained CFDA registration in China in December 2017
•Commenced set-up of our own specialisedoptical front-end manufacturing facility
•Announced a number of large international public health initiatives, mostly in China
•Continued a program of global awareness of TruScreen’scapabilities
•Successfully completed a capital raising campaign earlier in the financial year.
•The market capitalization of $48.17M today which represents an increase of +42%over the past 12 months.
FY 18 HIGHLIGHTS
TruScreen2018 Annual Meeting Presentation2

KEY FINANCIALS
As at 31 March 2018
FY18
Sales
(up 37% on FY17)
$804,062
Other income$1,374,581
Revenue from Ordinary Activities
(up 56% on 2017)
$2,178,643
Net Loss$(4,168,792)
Net Assets$11,615,882
Cash and Cash Equivalents$1,212,454
FY 18 HIGHLIGHTS
TruScreen2018 Annual Meeting Presentation3

SALES GROWTH
Q1Q2Q3Q4Q1Q2Q3Q4Q1Q2Q3 ForecastQ4 Forecast
FY 17FY 18FY 19
QUARTERLY SALES
TruScreen2018 Annual Meeting Presentation4
CE Mark
received for
TruScreen2
April 2016
TS1 Stocks sold
out Q4 FY17
Sales Q1 FY19 > Total Sales FY18
CFDA Approves TruScreen2:4
December 2017
First Post CFDA Sales orders from
China: 20 Dec 2017
TS2 under evaluation by CFDA: Q2 FY17 though to end Q3 FY 18

CLNICAL EVALUATION OF TRUSCREEEN:
Ongoing clinical performance evaluation at the Royal Hospital for Women in Sydney and at two
regional clinics in Australia. Ongoing results indicate that TruScreenwill substantially boost screening
capabilities in developing countries.
CORE CERTIFICATIONS
•International Quality Audited confirmed
•ISO 13485
•EC Certification
•CFDA approved
REGULATORY APPROVAL AWARDED IN SELECTED COUNTRIES
TruScreenapproved for import and sale in:
REGULATORY AND CLINICAL
TruScreen2018 Annual Meeting Presentation5
✓China✓Europe
✓Mexico✓Kazakhstan
✓Urkraine✓India
✓Jordan✓Turkey
✓United Kingdom✓Australia
✓New Zealand✓Vietnam
✓South Africa✓Zimbabwe

▪Major new sub distributor (Bio-Chem) appointed to manage government sales
channels
▪16 County hospitals conducting Centre for Disease Control evaluation & 3,000
community healthcare centres throughout rural China
▪Hospitals average 150 SUS per month, but some users now using 1,000 per
month
▪Major key opinion leader support from COGA
▪190 Hospital program in Xinjiang province
▪Selected by a private clinic group as the preferred cervical cancer primary
screening system for their new chain of state of the art clinics
▪Future: Proposed to assemble TruScreen Devices in China to increase rate of
government adoption.
CHINA
CHINA: THE FACTS
▪400 million women of screening age
▪Initial distribution agreement signed 2014
▪71% of FY18 of TruScreensales ($531k)
▪FY19 Budgeted sales $2.1mil
TruScreen2018 Annual Meeting Presentation6

▪Engaged major distributor in Mar 2017 –KLAB, with
700 employees
▪In Dec 2017 commenced Stage 1 (due to conclude
Oct 2018) of AIIMS evaluation of TruScreen to seek
endorsement for inclusion in the 2019 National
Ministry of Health budget
▪Cleared all import and other regulatory
requirements to sell TruScreen in India
INDIA AND MEXICO
INDIA: THE FACTS
▪300 million women of screening age
▪Distribution agreement signed 2017
▪Sales commencing in FY19
▪FY19 Budgeted sales $1.6mil
MEXICO: THE FACTS
▪31 million women of screening age
▪Distribution agreement signed 2015
▪12% of FY18 TruScreensales ($100k)
▪FY19 Budgeted sales $1.2mil
TruScreen2018 Annual Meeting Presentation7
•Clinical Trial showed TruScreen more than twice as sensitive as pap in
identifying high grade cervical changes (CIN2+)
•Endorsement by National Cancer Institute –Stage 2, 400 patients
commenced in Oct 2017
•Submitted revised application in July 2018 for inclusion in Cuadro
Basico–the government hospital purchasing catalogue
•Under evaluation by the main National Health Insurer, ISSSTE, (who
conduct 500,000 pap tests per year) and the govt oil monopoly Pemex
(who conduct 60,000 pap tests per year)

AFRICA & ZIMBABWE -Potentially a Significant Market
TruScreen2018 Annual Meeting Presentation8
AFRICA: THE FACTS
▪227 million women of screening age
▪13.1 million women in Africa suffer from HIV
▪17.8 million women globally suffer from HIV
▪HIV affected women are 6 times more likely
to develop Cervical Cancer
▪All HIV affected women should be screened
for Cervical Cancer annually
▪FY19 Budgeted sales $610k (FY18 $33k)
▪Zimbabwe Ministry of Health support for major funding application (up to
$30m over 4 years) to use TruScreen for a national screening program
▪First order received for approx. $450k by National Aids Council for cervical
cancer screening of HIV affected women
▪Zimbabwe is a Key Opinion Leader in Eastern Africa and it is anticipated that
the successful implementation of this innovative programme will lead to
other countries embracing TruScreen as a solution to their own cervical
cancer screening needs

SUBSEQUENT ACTIVITIES
The company has made significant progress since the end of the 2018 financial year. The key matters include the following:
•Sales to 30 September 2018 expected to be $1.578m (previous year $NZD 226K) and for the 12 months to 31 March 2018 budget $6.86m
(previous year $0.804m).
•Significant growth in sales to China ($508K in the first two quarters)
•Announced initiatives in Africa and Zimbabwe where TruScreenhas been selected by the Zimbabwe Ministry of Health as a preferred
screening tool for HIV affected women. An initial order of $450,000 has been received from the National AIDS Council and joint application
for $30m funding over four years has been lodged.
•Initiated a pilot study for the use of TruScreenin regional and remote locations by the Papua New Guinea government.
•Entered into a new distribution agreement in respect of the Middle East
•Successfully launched a new optical electrical front-end manufacturing facility in Sydney with increased capacity and profit margins
•Concluded clinical trials at the Royal Hospital for Women in Sydney into the performance of TruScreen2 with results to be published at the
World HPV symposium in October 2018.
•Completed a capital raising of $1.5 million.
TruScreen2018 Annual Meeting Presentation

•Expand sales by + 500%
•Achieve monthly profitability by year’s end
•Consider dual listing and / or migration to a larger exchange
•Consumateand expand government screening opportunities
•Achieve inclusion in Chinese, Indian and Mexican government programs
•Initiate discussions with global pharma distribution organisations
•Pursue major international health funding programs
•Continue to seek operational and manufacturing efficiencies
FY19 GOALS AND OBJECTIVES
TruScreen2018 Annual Meeting Presentation10

Contact us for more information
www.TruScreen.com
Martin Dillon
Chief Executive Officer
TruScreenLtd
T: +61 2 9091 7475
E: martindillon@truscreen.com
TruScreen2018 Annual Meeting Presentation11

Disclaimers
This presentation should be viewed in conjunction with TruScreen’s Financial Statements for the 12 monthsto 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 assurancethatactual outcomes will notmaterially differ from the forward looking statements presented.
A number of important factors could cause actual results or performanceto differ materiallyfromtheforward-looking statements.Theforward-looking statements are
based on information available toTruScreen as at thedateof this presentation. Except as requiredby law (including the NZAX ListingRules), TruScreen undertakes no
obligation to provide any additional orupdatedinformation whether asa 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.
TruScreen2018 Annual Meeting Presentation12

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TruScreen Annual Meeting
September 2018
Shareholders Address

FY18 ANNUAL MEETING
SHAREHOLDERS ADDRESS
27 SEPTEMBER 2018

INTRODUCTION
Welcome to the 2018 AGM.

FY18 HIGHLIGHTS
2018 was a year of significance as the company entered full commercialisation
late in the financial year.
Some of the key operational highlights include:

• Strong sales growth of 2
nd
Gen TruScreen to China commenced during 4
th

quarter. (50% of the year’s sales were generated in the fourth quarter)


• Completed the testing and validation in February 2018 of its second-generation
device including in market clinical trials where impressive results were obtained.


• Expanded its global sales and distribution network into Africa, Latin America and
India (covering a combined screening population of approx. 1 billion women)


• Obtained CFDA registration in China in December 2017

• Commenced set-up of our own specialised optical front-end manufacturing
facility


• Announced a number of large international public health initiatives, mostly in
China


• Continued a program of global awareness of TruScreen’s capabilities


• Successfully completed a capital raising campaign earlier in the financial year.

FY18 FINANCIAL RESULTS


• A review of the year’s financial results indicates that total revenue of $2.178 M
which was up +56% on that of the prior year.


• The company incurred a net loss of $4.168 M for the FY18 year. This loss was
slightly greater than expected due to the delay obtaining CFDA approval in China.


• The company was successful in raising additional $4.9M of capital at 16c (a +31 %
increase as of today).


• A healthy financial position at the end of the financial year with net assets of
$11.615 M, cash and cash equivalents of $1.212 M and a normal operational cash
burn of $200k per month.

• The market capitalization of $48.17M today which represents an increase of
+42% over the past 12 months.


• Zero debtor financial risk (i.e. all debtors paid in full)

REGULATORY and CLINICAL MATTERS

• Chinese CFDA approval in December 2017


• Regulatory approval in other jurisdictions including Mexico, Ukraine, Jordan, UK,
South Africa, India, Turkey, Vietnam, Europe, Kazakhstan and Zimbabwe.


• The Royal Hospital for Women in Sydney completed an important trial to
determine the clinical capability of TruScreen.


• The company successfully completed its International Quality audit, and its ISO
13485 Quality Certification, and EC Certification in Europe were maintained.


• Trials at the National Institute of Cancer in Mexico were conducted and they
have supported our application for government purchasing approval.


• Commenced clinical trial in India at the All India Institute of Medical Science
(AIIMS)

MARKET UPDATE
Generation of sales during the financial year were initially slow due to delays in
obtaining regulatory approval in our key market, China. However, sales escalated
significantly in the fourth quarter as the company commenced supplying a
backlog of sales orders to China.
A brief summary of our individual markets during the year is as follows:

a) China

Facts:
▪ 400 million women of screening age
▪ Initial distribution agreement signed 2014
▪ 71% of FY18 of TruScreen sales ($531k)
▪ FY19 Budgeted sales $2.1mil

• Regulatory approval (CFDA) for the 2
nd
generation device obtained in December
2017. (A significant portion of the year’s sales were supplied to China in the
fourth quarter)


• Appointed a new sub- distributor (Biochem) in China who will have the major
focus of managing government sale channels


• Selected as the preferred primary screening solution for a chain of high-tech
female health clinics to be established in 50 municipal hospitals throughout
China.

• Truscreen has reached agreement for TruScreen to be installed in 190 public
hospitals in the Xinjiang province


• Reached agreement with the Women and Childrens division of the Centre for
Disease Control (CDC) for a program involving 12,000 women in China


• Commenced a major product evaluation involving 10,000 patients by the Chinese
Obstetrics and Gynaecological Association (COGA)

b) Mexico
Facts:
▪ 31 million women of screening age
▪ Distribution agreement signed 2015
▪ 12% of FY18 TruScreen sales ($100k)
▪ FY19 Budgeted sales $1.2mil

• The Ministry of health in Mexico commenced a valuation of Truscreen for
inclusion in the Mexican government’s catalogue of preferred medical devices
for use in public hospitals. This evaluation is currently overdue and expected
shortly

• Clinical Trial results showed TruScreen + 200% more sensitive than pap in
identifying high grade cervical changes (CIN2+)

• Regulatory:
• Endorsed by National Cancer Institute – Stage 2, 400 patients commenced
in Oct 2017
• Submitted revised application in July 2018 for inclusion in Cuadro Basico
(the government hospital purchasing catalogue)
• Evaluation commenced by the main National Health Insurer, ISSSTE(who
conduct 500,000 pap tests per year)

c) India
Facts:
▪ 300 million women of screening age
▪ Distribution agreement signed 2017
▪ Sales commencing in FY19
▪ FY19 Budgeted sales $1.6mil

• Appointed major distributor in Mar 2017 – KLAB

• Commenced clinical trial in India at the All India Institute of Medical Science
(AIIMS)

• Cleared all import and other regulatory requirements to sell TruScreen in India

b) Africa/Zimbabwe
Facts:
▪ 227 million women of screening age
▪ 13.1 million women in Africa suffer from HIV
▪ 17.8 million women globally suffer from HIV
▪ HIV affected women are 6 times more likely to develop Cervical Cancer
▪ All HIV affected women should be screened for Cervical Cancer annually
▪ FY19 Budgeted sales $610k (FY18 $33k)

• Zimbabwe Ministry of Health support for major aid application (up to $30M over
4 years) to use TruScreen for a national screening program.

• First order received for approx. $450k by National Aids Council for cervical cancer
screening of HIV affected women.

• Zimbabwe is a Key Opinion Leader in Eastern Africa and it is anticipated that the
successful implementation of this innovative programme will lead to other
countries embracing TruScreen as a solution to their own cervical cancer
screening needs.

Subsequent Activities

The company has made significant progress since the end of the 2018 financial
year. The key matters include the following:

• Sales to 30 September 2018 expected to be $1.578m (previous year $NZD
226K) and for the 12 months to 31 March 2018 budget $6.86m (previous year
$0.804m).

• Significant growth in sales to China ($508K in the first two quarters)

• Announced initiatives in Africa and Zimbabwe where TruScreen has been
selected by the Zimbabwe Ministry of Health as a preferred screening tool for
HIV affected women. An initial order of $450,000 has been received from the
National AIDS Council and joint application for $30m funding over four years
has been lodged.

• Initiated a pilot study for the use of TruScreen in regional and remote locations
by the Papua New Guinea government.

• Entered into a new distribution agreement in respect of the Middle East

• Successfully launched a new optical electrical front-end manufacturing facility
in Sydney with increased capacity and profit margins

• Concluded clinical trials at the Royal Hospital for Women in Sydney into the
performance of TruScreen2 with results to be published at the World HPV
symposium in October 2018.

• Completed a capital raising of $1.5 million.

2019 Goals and Objectives
▪ Expand sales by + 500%

▪ Achieve monthly profitability by year’s end

▪ Consider dual listing and / or migration to a larger exchange

▪ Consumate and expand government screening opportunities

▪ Achieve inclusion in Chinese, Indian and Mexican government programs

▪ Initiate discussions with global pharma distribution organisations

▪ Pursue major international health funding programs

▪ Continue to seek operational and manufacturing efficiencies

Closure

As founder, largest shareholder and Chairman for the past four years I advised
the Board several months ago that I propose to step down as Chairman effective
at the close of this meeting. A new Chairman will be appointed by the board and
I take this opportunity to thank all shareholders for their past support.