GENERAL MEETING 2017 CHAIRMANS ADDRESS 2. THE TRUSCREEN TEAM - - PowerPoint PPT Presentation

ANNUAL GENERAL MEETING 2017 CHAIRMAN’S ADDRESS

BOARD OF DIRECTORS LEADERSHIP TEAM Robert Hunter - Chairman Martin Dillon, CEO Christopher Horn – Independent Director Dr Colin Stahel, Manager Marketing and Medical Technology Sean Joyce – Independent Director Dr Jerry Tan, GM International Business Development Timothy Preston – Independent Director Paul Curran, GM Quality and Regulatory James Haindl, Biotechnologist ADVISORY BOARD Dr Graham Pulford, Senior Algorithm Engineer

• Prof. Neville Hacker AM

Dr Akila Seneviratne, Algorithm Developer

• Prof. Ronald Jones CNZM

Dr Carolina Velasquez, Clinical Research and Training Officer Assoc Prof. Michael Campion Dr John Blakemore

• 2. THE TRUSCREEN TEAM

OUR VISION To provide better cervical cancer screening to women around the world and by doing so, improve the health and wellbeing of women and help to save thousands of lives GLOBAL MARKET FOR CERVICAL CANCER SCREENING Forecast to exceed US$22 billion p.a. in the next three years OUR FOCUS Women in developing countries with low resource health economies, which lack a laboratory infrastructure and expert diagnostic technicians, and which account for up to 80% of deaths from cervical cancer. THE FACTS

• Cervical Cancer is the number 3 cause of

death by cancer in women worldwide

• > 250,000 deaths annually
• 80% of deaths occur in developing countries
• These countries have zero or limited

screening infrastructure – laboratories, patient recall systems etc

• TruScreen needs no laboratory infrastructure
• TruScreen is targeted to developing

countries.

• 3. THE OPPORTUNITY

• 4. OUR MARKETS

RESEARCH AND DEVELOPMENT DISTRIBUTION PARTNERSHP AWARENESS AND ACCEPTANCE ADOPTION AND INITIAL SALES MATURE SALES

• Development of first

and second generation devices and algorithm

• Clinical validation
• Identify and partner

with a reputable distributor, which has an existing network and contacts in country

• Build awareness and

acceptance of TruScreen

• Rollout of commercial

programme

• Adoption by Key

Opinion Leaders

• Clinical trials and in-

market validation

• Presentation at major

conferences and congresses

• Initial sale of TruScreen

devices

• Low initial usage of

Single Use Sensors per device

• Building usage as Doctor

and patient acceptance grows

• Increasing device sales
• Ongoing, repeat sale of

Single Use Sensors as usage per device increases

• 5. ROAD TO COMMERCIALISATION

2017: CURRENT STAGE OF COMMERCIAL JOURNEY

• Re-certified TruScreen1 and sold all TruScreen1 Inventory
• Created and certified TruScreen2 – provides a significant improvement in

performance, speed and capability

• Establishing our global footprint: Distribution agreements in place in 24 countries,

with key focus on China, Mexico, Russia, India and Europe/Middle East

• Establishing new manufacturing capabilities
• Gaining support from Key Opinion Leaders
• Completed a number of in-market clinical trials with overwhelmingly positive results
• Close to completion on TruScreen Algorithm Improvement Programme

KEY FINANCIALS FY17 Sales 585,388 Other income 810,202 Revenue from Ordinary Activities 1,395,590 Net Loss (3,540,610) Net Assets 14,324,288 Cash and Cash Equivalents 3,671,571

• 6. OUR COMMERCIAL PROGRESS IN PAST TWO YEARS

FY18 Goals and Strategic Progress

• 7. FY18 GOALS AND STRATEGIC

PROGRESS

7.1 Performance evaluation of TruScreen2 7.2 Regulatory approval for TruScreen2 in selected countries 7.3 Seek inclusion in Government Screening Programmes 7.4 Further establish TruScreen’s global distribution network 7.5 Enhance sales of TruScreen2

• Ongoing clinical performance evaluation at the Royal Hospital for Women in Sydney

and at two regional clinics in Australia

• Initial results have been excellent
• Shows TruScreen2 to be a substantially more accurate screening method than cytology

TRUSCREEN PERFORMANCE Interim results RHW (2017): Excellent. 96% Negative Predictive Value TruScreen2 at RHW (2017) Sensitivity to CIN2+ 90% Specificity 78% TruScreen1 at Guadalajara (2016) Sensitivity to CIN2+ 78% Specificity 64% TruScreen1 at Singer et al (2003) Sensitivity to CIN2+ 70% Specificity 80%

7.1 PERFORMANCE EVALUTION OF TRUSCREEN2

Pap and HPV in TruScreen’s Markets – Sensitivity to CIN2+ Guadalajara (2016) HPV DNA 56% PAP 36%

• TruScreen2 approved for import and sale in:

 Europe  Russia  Mexico  Kazakhstan  Ukraine  India  Jordan  Turkey  United Kingdom  Australia  New Zealand  Vietnam

• Close to receiving CFDA approval in China – expected in Q3 of FY2018

7.2 REGULATORY APPROVAL IN SELECTED COUNTRIES

CHINA

• Currently in use in three large scale screening programmes
• 41,000 women screened out of potential 390,000 women
• Pace will pick up once TruScreen2 certified
• Assessing opportunities for other programmes in China

INDIA

• Close to 300 million women of screening age
• Have commenced first stage of in-country validation to have

TruScreen2 considered for adoption for large scale Indian Government screening programmes

• Evaluation expected to be completed by calendar year-end

MEXICO

• Commenced evaluation by Ministry of Health
• Government hospital purchases expected in Q3 of FY18

7.3 GOVERNMENT SCREENING PROGRAMMES

Focus is on creating depth in largest markets – China, India, Russia and Mexico Via:

• Endorsement from Key

Opinion Leaders

• Government adoption
• Use in major screening

programmes

7.4 GLOBAL DISTRIBUTION NETWORK

• Sales dependent on regulatory approvals in each

country/region

• Expect to see sales increase as early adopters

transition to commercial users

• Anticipated increase in both the number of

devices sold and the number of Single Use Sensors used per device

• Building up inventory stocks to meet anticipated

future demand

7.5 ENHANCE SALES

FY18 Goals and Strategic Progress

• 8. OUR MARKETS

• Major new sub distributor (Bio-Chem) appointed to manage government sales

channels

• 10 county hospitals conducting Centre for Disease Control evaluation – 30,000

community healthcare centres throughout rural China

• Two new provinces (Heilongjiang and Jilin) added to commercial footprint
• PLA General Hospital increased monthly usage from 200 tests (September

2016) to 1000 tests (June 2017)

• Gained pre-CFDA approval to import and install TruScreen2 for clinical

evaluation in selected hospitals

• Following CFDA approval expect to immediately commence supplying

TruScreen2 for commercial use.

8.1 CHINA

CHINA: THE FACTS

• 400 million women of screening age
• Initial distribution agreement signed 2014
• 28% of FY17 TruScreen sales

• Clinical Trial showed TruScreen more than twice as sensitive as pap in identifying high

grade cervical changes (CIN2+) Working on the following activities:

• Endorsement by National Cancer Institute – Stage 2, 400 patients, to commence in

October

• Submitted application for inclusion in Cuadro Basico – the government hospital

approved purchasing catalogue

• Submission prepared for major Health Secretariat tender – awaiting Cuadro Basico
• Currently under evaluation by three state government health secretariats and

negotiating with a further six state governments for inclusion in their programmes

• Under evaluation by the main National Health Insurer, ISSSTE, in four of their hospitals,

for inclusion in their programs (ISSSTE conduct 500,000 pap tests per year)

• Under evaluation by the national oil monopoly, PEMEX, in two of their hospitals, for

inclusion in their programmes (PEMEX-owned hospitals conduct 60,000 pap tests per year)

MEXICO: THE FACTS

• 31 million women of screening age
• Distribution agreement signed 2015
• 20% of FY17 TruScreen sales

8.2 MEXICO

• Engaged major distributor – KLAB, with 700

employees

• Finalised protocols and arrangements for the

commencement of Stage 1 of the Indian Government (BIRAC) 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

8.3 INDIA AND RUSSIA

INDIA: THE FACTS

• 300 million women of screening age
• Distribution agreement signed 2017
• Sales commencing in FY18
• Prof Rogowskaya included TruScreen in draft

screening recommendations for the All Russia Society of Obstetricians and Gynaecologists

• Preparing submission for TruScreen to be used in

Moscow non-metropolitan screening program (potential is 500,000 women)

RUSSIA: THE FACTS

• 44 million women of screening age
• Distribution agreement signed 2015
• Sales increasing in FY18

• Distribution footprint covers 14 countries
• Establishing KOL support and government endorsement

prior to commercial roll out

EUROPE AND CENTRAL ASIA: THE FACTS

• Distribution agreements signed 2016/17 –

Turkey, Poland, Croatia, Slovenia, Bosnia- Herzegovina, Kosovo, Serbia, Montenegro, Germany, Switzerland, Austria, Ukraine, Kazakhstan

• 90 million women of screening age
• 43% of FY17 TruScreen sales

(Russia included)

8.4 OTHER MARKETS

• Distribution footprint covers seven countries, including Iran

and Iraq

• Establishing KOL support and government endorsement

prior to commercial roll out

• Seeking health insurance reimbursement approval in

multiple markets

MIDDLE EAST: THE FACTS

• Agreements signed 2016 – Iran, Iraq Jordan,

Saudi Arabia, UAE, Turkey

• 51 million women of screening age
• 9% of FY17 TruScreen sales

FY18 Goals and Strategic Progress

• 9. LOOKING FORWARD

• Finalise the performance evaluation of the TruScreen2 device and the TruScreen2

Algorithm

• Continue development of the TruScreen algorithm and submit it for clinical evaluation
• Obtain regulatory approval for TruScreen2 in China
• Submit TruScreen2 for adoption in selected international government screening

programmes

• Further establish our global distribution networks
• Focus on deeper penetration of TruScreen into our key markets
• Expand TruScreen2 manufacturing capability

9.1 FY18 PRIORITIES

FY18 Goals and Strategic Progress

• 10. BUSINESS OF THE MEETING

SHAREHOLDER DISCUSSION

RESOLUTION 1: Re-election of Tim Preston as a director RESOLUTION 2: Record the appointment of BDO Auckland as auditors of the Company and authorise the directors to fix the auditors’ remuneration.

• 11. RESOLUTIONS

FY18 Goals and Strategic Progress

OTHER BUSINESS CLOSE OF THE MEETING

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

Disclaimers

This presentation should be viewed in conjunction with TruScreen’s Financial Statements for the 12 months to 31 March 2017 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 assurance that actual outcomes will not materially differ from the forward looking statements presented. A number of important factors could cause actual results or performance to differ materially from the forward-looking statements. The forward-looking statements are based on information available to TruScreen as at the date of this presentation. Except as requiredby law (including the NZAX Listing Rules), TruScreen undertakes no

• bligation 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 bodies corporate, directors, officers, partners, employees and agents make no representation or warranty, express or implied, as to the currency, accuracy, reliability or completeness of information in this presentation.