TRUSCREEN GROUP LIMITED logo

Updated Investor Presentation

Insider/Shareholder Notice20 May 2020TRUIndustrials

INVESTOR PRESENTATION
May 2020(NZX: TRU)

A world without cervical cancerCervical Cancer can and should be prevented. Truscreen provides an accurate, re
al time screening solution.

Our screening solution is idea

l 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 they are – can have access to quality screening

.

2

Cervical cancer is a major public health issue
Fourth most common cancer, affecting women►

570,000 new cases each year

►

311,000 deaths p.a.

Young women in low and middle incomecountries (LMIC) are most at risk►

Most diagnoses occur at age 35-44

►

85% of cases and 87% of deaths occur in LMICs

1BN+ women of screening age

in LMICs – this is our focus

3

90%
coverage of HPV

Vaccination of girls (by 15 years of age);

WHO has set a target to eliminate cervical cancer by the end of the century

WHO GLOBAL TARGETS FOR 2030

70%

coverage of screening

(70% of women are screened with high-performance tests by the ages of 35 and 45 years) and 90% treatment of precancerous lesions;

Management of 90%

of invasive

cancer cases

4

►
LMICs – lowest screening rates, highest incidence and mortality rates

►

Innovative service delivery models are required, if LMICs are to meet screening targets

►

TruScreen’s disruptive model offers this•

No reliance on lab infrastructure

•

Accurate real time screening

•

Easy to learn

•

Affordable

►

TruScreen already has a presence in many of these markets – and the support of Key Opinion Leaders, NGOs and government organisations

The opportunity for TruScreen

5

Access to screening programs has been limited due to:
TruScreen’ssolution is ideal for LMICs

Access to ‘’no lab’’, accurate, simple to use and affordable screening essential

TRUSCREEN HAS CLOSE TO 1bln WOMEN ELIGIBLE FOR

SCREENING IN KEY MARKETS

Russia (44m)

China (401M)

Middle East (70M)

Vietnam (30M)

Zimbabwe (4M)

TruScreen’s current markets

Targeting commercial roll-out

►

Lack of laboratory infrastructure

►

No HPV vaccination programs

►

Shortage of diagnostictechnicians

Mexico (31m)

India (302M)

6

Investment highlights
The only real-time cervical screening method available in LMICs

Disruptive technology, high potential

Clinical and commercial validation

Attractive commercial model

Poised for growth

►

Real-time, single visit, mobile screening technology

►

No lab infrastructure required, nurse administered

►

Recognised by WHO, UNITAID and the Clinton Health Access Initiative

►

Sensitivity and specificity equal to, or better, than alternative screening tools

►

Clinically tested on over 40,000 women in 25 studies across 20 countries

►

Established user base / KOL support in key markets

►

Targeting large markets

►

Lean distributor-based model

►

Annuity revenue stream

►

Ramping up in existing markets to deliver sales growth amid COVID impact

►

New markets (India, Viet

nam) coming on board

►

Manufacturing process enhancements to deliver double-digit margin improvement

7

17.4%
8.8%7. 3 %5.3%

$0.071 (as at 15 May 2020)$1M (as at 31 March 2020)Consolidated NomineesBrowns Island Holdings LtdWaitara Trustees LimitedNZ Central Securities

Market cap

Share price

Cash position

NZ$16.2M (as at 15 May 2020)

Significant shareholders

Financial overview ($NZD)

8

0.0 m0.1 m0.2 m0.3 m0.4 m0.5 m0.6 m0.7 m0.8 m0.9 m1.0 m

0.040.060.08

0.1

0.120.140.160.18

0.2

Apr‐19 Jun‐19 Aug‐19 Oct‐19 Dec‐19 Feb‐20 Apr‐20

Volume (m)

Share price ($)

Volume

A capital raising closed on 15 May 2020, which raised NZ$3.743 million.

Charging station
TruScreen

Device

Single Use Sensor

(SUS)

How it works►

Low electrical charge and light examines the cervix’s surface

►

Uses algorithm to determine if cervix tissue is normal or abnormal

9

Competitive advantagePatients►
Real-time results

►

Painless

►

Non-Invasive

TRUSCREEN

Clinics►

Objective readings

►

Minimal training

►

Cost effective

►

Single visit

►

Portable

Technology►

No requirement for lab

►

User-friendly

►

Accurate readings

PAPPatients►

Repeat visit

►

Scraping of cervix

Clinics►

Widely varying accuracy

►

Human error

►

Labour intensive

►

Long wait times

(days/weeks/months)

►

Vaccines don’t cover all

►

HPV types

Technology

10

Compelling market opportunity
End customers

►

NZD $166M addressable market p.a.*

►

SUS creates annuity revenue

►

Co-investment model with distributors, lean organizational structure

TruScreen’s local distributors target:

►

Public hospitals

►

Private hospitals

►

Public health initiatives

►

Governments

►

Non-Government Organisations

TruScreen device

Single Use Sensors

(SUS)

*

Based on TruScreen achieving 5 per cent market share of developi

ng markets’ cervical cancer screening age population screened on

ce every three years

11

Sustainable ‘razor-blade’ revenue model

12
Video: Acceptance in one of our core markets (Russia)

Please click on the following link to upload the vi

deo, or copy and paste the link to your browser

https://truscreen.com/news/truscreen-market-acceptance-russia/

Listing on
NZAX

2014 Nov

2017 Dec

CFDA approval for

second generation

device

Listing on

NZAX

2018 Jul

2018 Jul

Commence large

scale pilot with China

CDC and COGA

523% sales

growth in H1

2018 Oct

2018 Dec

Migration to NZX

Recognition

by World

Health

Organization

2019 May

2019 Sep

China COGA study

first screening results

exceed expectations

•

Strengthen / growing team

•

Recovery COVID-19

•

Margin improvement

•

Further roll-out in China & Russia

•

Setting commercial roll-out in Vietnam and India

2020 - 2022

2022 & onwards

•

Rollout Gen 3 device

•

Rapid non-linear sales growth

•

Company growth to support the sales

•

Strategic partnerships

Setting the fundamentals

Transformation

Rapid growth

2014 - 2019

13

Our commercialization journey

Drive adoption in established markets and new markets►
Continue roll-out in more established markets (China, Russia, Zimbabwe)

►

Drive adoption and prepare roll-out in India and Vietnam based on successful clinical trials finalized recently

►

Seed in promising LMIC markets (Eastern Europe, Asia Pacific)

Relentless focus on product quality and innovation ►

New Quality Assurance (QA) systems implementation

►

Ongoing improvement of device in line with feedback from markets

►

Generation 3 product development and launch

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 (CEO, CTO)

►

Leverage digital solutions for QA, training & education, sales support

►

Grow the team in line with sales progress/business needs

►

Establish on-going team upskilling

14

Growth Strategy

China – Most Advanced Market & Largest Opportunity
►

Truscreen’s largest market (57% of sales)

►

World’s largest cervical cancer market

►

First distribution agreements signed in 2014

►

Pilot program of 20,000 women with Centre for Disease Control (CDC)

►

Clinical study with Chinese Obstetricians & Gynaecologists Association (COGA) of 20,000 women in public hospitals – results from Hunan province released and exceeded expectations

►

Hospital usage of SUS: Up to 1,000 per month

Market

Screening population

NGO/KOLengagement

Pilotprogram

Distribution/sales commenced

Number of devices installed

China

401M

Yes

Yes

Yes

58

Mexico

31M

Yes

Yes

Yes

10

Russia

44M

Yes

Yes

Yes

29

India

300M

Yes

Yes

No

0

Zimbabwe

30M

Yes

Yes

No

0

Vietnam

26M

Yes

Yes

No

0

Key Markets

15

Key markets

Key variances
RevenueGross ProfitResearch and DevelopmentMarketing

►

Initiated major initiative for SUS cost reduction, signing long-term contract with SUS supplier

►

Optimising total overheads via revisiting the external suppliers network and ruthless prioritization of activities

►

R&D costs reducing as product matures

►

Investment in business capability and people

►

Negatively impacted by COVID-19

►

Chinese business gradually recovering after COVID-19 outbreak, expect improvement from Q2 2020

►

R&D 2020 includes positive adjustment from 2019

Operating EBITA

►

Improved in 2020 with lower R&D spend and benefit of

positive adjustment on 2019 R&D receipt

KEY FINANCIALS NZD (m)

FY17Actual

FY18Actual

FY19Actual

FY20Estimate

% Change

FY20/FY19

Sales

0.6

0.8

1.9

1.3

- 40%

Total Revenue

1.4

2.2

3.1

2.5

- 19%

COGS

.47

.74

1.4

0.9

-

R&D

1.2

1.9

1.7

0.9

-

Marketing

.56

.39

.29

.47

-

G&a

2.1

2.7

2.5

2.8

-

EBITDA

(3.0)

(3.6)

(2.8)

(1.7)

+40%

Net Assets

14.3

11.6

11.3

9.8

Cash and CashEquivalents

3.7

1.2

1.7

1.0

-60%

Net Assets

►

Net assets subject to audit review of carrying value of intangibles given uncertainty of COVID-19

16

Financials

$0
$500,000

$1,000,000$1,500,000$2,000,000$2,500,000$3,000,000$3,500,000

2019

2020

Total revenue

$1,200,000$1,230,000$1,260,000

2019

2020

R&D Income

$0

$200,000$400,000$600,000$800,000

$1,000,000

2019

2020

Device revenue

$0

$200,000$400,000$600,000$800,000

$1,000,000$1,200,000

2019

2020

Consumables (SUS)

Full-Service Distribution Chanel•

SUS revenue will grow at a higher rate than Device revenue

•

SUS revenue will become a sustainable recurring revenue stream

•

The device has an expected lifetime of 5-7 years and the SUS is used once per test per patient

0 yrs.

5 yrs.

Device

SUS

Device and SUS Revenue

Revenue, $NZ

18
►

“Return to normal” in China – supporting business as China recovers from COVID-19

►

Implementation of improved electronic quality assurance system

►

Hire Chief Technology Officer

►

Overhead reduction program via review of all external suppliers and revisit priority activities

►

SUS cost reduction program initiated > new contract terms with SUS supplier, long-term agreement

►

Continue to prepare for dual ASX listing

Milestones: Near-term

Business transformation underway

19
►

Targeting double-digit percentage revenue growth despite COVID-19 impact

►

Further roll-out in China to reach installed devices base of min 70 hospitals (+43% vs 2020)

►

Continue with the roll-out in Russia and initiate the roll-out in Vietnam and India

►

Implementation of a comprehensive device traceability QA system

►

Achieve double digit percentage reduction of SUS cost to boost GP

►

Commence local device assembly in China

►

Generation 3 development > improved product design in line with customers’ feedback

Milestones: Next 12 months

Focus on rapid non-linear sales growth once COVID-19 restrictions are lifted

CEOVictoria Potarina
►

More than 20 years commercial experience

►

Previously worked at Johnson and Johnson across UK and Europe

►

Held positions at multiple multinational companies in the FMCG, over-the-counter, medical devices and healthcare sectors

CFOGuy Robertson

►

Chartered accountant with 30 years financial management and leadership experience

►

CFO & Company Secretary for TruScreen

GM International BDDr Jerry Tan

►

Qualified gynaecologist

►

Extensive experience in China, and East Asia

►

Oversees distributors, market evaluation and clinical trials

Chief Technology Officer

►

Expert in Healthcare Compliance including medical device licensing and quality assurance

►

Responsible for manufacturing, research and development, registrations and quality assurance

GM Quality & Regulatory Compliance

Paul Curran

►

Key role to be hired

20

Invigorated and experienced executive team

ChairmanTony Ho►
Non-executive chairman of Greenland Minerals (ASX: GGG) and Bioxyne(ASX:BXN)

►

Chairmen of CannasouthLimited (NZX: CBD)

►

Past NED of Hastings Technology Metals (ASX:HAS) and Brazin (ASX:BRZ)

Non Executive Director Christopher Horn

►

Chair of Audit, Finance and Risk Committee

►

20 years as a partner of KPMG and its predecessor firms.

Non Executive DirectorChris Lawrence

►

Experienced life science and biotech investor

►

Strong experience in high growth companies, particularly in biotech sector

►

Member of Audit, Finance and Risk Committee

►

Senior healthcare executive with 30+ years experience in international and medical device businesses

Non Executive DirectorCon Hickey

21

Board of directors with extensive experience

Contacts Tony Ho, ChairmanVictoria Potarina, CEOGuy Robertson, CFO
www.truscreen.comE: victoriapotarina@truscreen.com

22

APPENDIX
23

Market entry and development
Build awareness•

Key opinion leader (KOL) engagement and endorsement

•

Medical conferences


•

Clinical trials/studies

Expand global footprint•

Local distributor strategy

•

Public health initiatives

•

Partnerships with Non-Government Organisations and Government agencies

Technology transfer to key markets

SS1

Doctor acceptance
(1)

•

152 women surveyed at the Whittington Hospital, London82% preferred TruScreen

•

2% preferred the Pap smear

•

Main factors cited for TruScreen preference were immediate results, less pain or discomfort

•

> 60% of doctors rated TruScreen at 4 – 5 out of 5

•

The two main advantages cited were TruScreen’sreal time results and the absence of a need for laboratory facilities and personnel

Patient acceptance

(2)

201612

840

a.. Real-time results-

Patients are not lost to

follow-up

b. No laboratory

facilities or trained

cytologists needed

c. Objective, self-

checking procedures

ensure consistent and

reproducible results

d. High accuracy

and earlier

detection of

precancerous

lesions

e. Non-

invasive, less

discomfort to

women

25

Acceptance of TruScreen

TruScreen1 at Guadalajara (2016)
Sens

itivity to CIN2+ 78%

Specificity 64%

TruScreen1 at Li Xia et al in China (2011)

Se

nsitivity to CIN2+ 81.7%

Specificity 79.6%

TruScreen1 at Guangdong China (2010)

Sensit

ivity to CIN2+ 78.8%

Specificity 74.4%

TruScreen1 in Shandong China (2010)

Se

nsitivity to CIN2+ 75%

Specificity 85%

TruScreen’s performance

Interim results RHW (2017): Excellent. 93% Negative Predictive ValueInterim results Hunan China (2019): Se

nsitivity: 89.29%; Specificity: 87.17%

PAP and HPV in TruScreen’s markets – Sensitivity to CIN2+

Guadalajara (2016)

HPV DNA 56%

PAP 36%

TruScreen in Hunan China (2019)

HPV DNA 92.86%

PAP 67.87%

TruScreen1 at Guangdong China (2010)

PAP 42.2%

TruScreen1 in Shandong China (2010)

PAP 43%

26

Clinical Data

Professor Neville Hacker AM
•

Professor Neville Hacker is conjoint Professor of GynaecologicalOncology 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.

•

He is a past President of the Society of Pelvic Surgeons. He is a pastPresident of the International Gynae

cological Cancer Society, former

Chairman of the Oncology Committee of the RANZCOG, and a formerChairman of Examiners for Gynaecologic Oncology, RANZCOG.

Clinical Advisory - Professor of GynaecologicalOncology

Colonel (Dr.) Michael J. Campion –Chairman

•

Colonel (Dr.) Michael J. Campion is a Senior Staff Specialist and Head ofthe Pre Invasive Clinic at the Gynaecological Cancer Centre of the RoyalHospital for Women in Sydney and is a Conjoint Associate Professor,School of Women’s and Children’s Health, at the University of New SouthWales.

He has over 30 years’ experience as a qualified medical

practitioner and over 20 years of experience as an expert colposcopist.

•

In addition, Dr. Campion is the Director, Health Services Army Reserve –

Eastern Region for the Royal Australian Army Medical Corps and is both

a Board member and National Hospitaller, St John Ambulance,Australia. Dr. Campion has written numerous peer reviewed papers andchapters on cervical cancer, including papers on TruScreen.

RAAMC, CStJ, KM, KCHS, KLJ

27

Experienced medical advisory board

Intellectual property
•

TruScreen uses trade secrets to

ensure protection against IP

infringement

•

Enumerated in the appendices to the Marrakesh Agreement which established the World Trade Organisation

•

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 Recogn

ition Using Multiple Measurement

(ZL201210439914.9)

•

Trademarks for “TruScreen” and “SUS” (English and Chinese equivalent)

IP coverage:

28

DisclaimersThis presentation has been prepared by TruScreen Limited (the “
Company”) and is dated 18 May 2020.

 This presentation contains s

ummary information about the Co

mpany and its activities which i

s current as at the date of this presentation. 

The information in this presenta

tion is of a general nature and

 does not purport to be complete nor does it contain all the in

formation which a prospective investor may require in evaluatin

g a possible investment in the Company. This 

presentation should be read in conjunction with the Company’s a

nnual report, market releases and other periodic and continuous

 disclosure announcements, which are available at 

www.nzx.com

. This presentation does not constitute an 

offer, advertisement or invitation in any place in which, or to

 any person to whom, it would not be lawful to make such an off

er, advertisement or invitation. 

Not financial product adviceThis presentation is for information purposes only and is not f

inancial or investment advice or a recommendation to acquire th

e Company’s securities, and has been prepared without taking in

to account the objectives, financial situation or 

needs of prospective investors. 

Before making an investment dec

ision, prospective investors should consider the appropriatenes

s of the information having regard to their own objectives, fin

ancial situation and needs and consult a financial 

adviser, solicitor, accountant or other professional adviser if

 necessary.

Past performanceAny past performance information given in this presentation is 

given for illustrative purposes 

only and should not be relied u

pon as (and is not) an indication of future performance. No rep

resentations or warranties are made as to the 

accuracy or completeness of such information.Future performanceThis presentation includes certain “forward‐looking statements”

 about the Company and the environment in which the Company ope

rates. Forward‐looking information is inherently uncertain and 

subject to contingencies, known and 

unknown risks and uncertainties and other factors, many of whic

h are outside of the Company’s control, and may involve signifi

cant elements of subjective judgement and assumptions as to fut

ure events which may or may not be correct. A 

number of important factors could cause actual results or perfo

rmance to differ materially from any forward‐looking statements

. No assurance can be given that actual outcomes or performance

 will not materially differ from the forward‐

looking statements. The forward‐

looking statements are based on

 information available to the Company as at the date of this pr

esentation. Except as required by law or regulation (including 

the Listing Rules), the Company undertakes no 

obligation to provide any additional or updated information whe

ther as a result of new information, future events or results o

r otherwise.

29

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