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

ANNUAL GENERAL MEETING 2017 CHAIRMAN’S ADDRESS

2. THE TRUSCREEN TEAM 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

3. THE OPPORTUNITY OUR VISION THE FACTS To provide better cervical cancer screening to women around the world and by • Cervical Cancer is the number 3 cause of doing so, improve the health and wellbeing of women and help to save death by cancer in women worldwide thousands of lives • > 250,000 deaths annually GLOBAL MARKET FOR CERVICAL CANCER SCREENING Forecast to exceed US$22 billion p.a. in the next three years • 80% of deaths occur in developing countries OUR FOCUS • These countries have zero or limited screening infrastructure – laboratories, Women in developing countries with low resource health economies, which patient recall systems etc lack a laboratory infrastructure and expert diagnostic technicians, and which account for up to 80% of deaths from cervical cancer. • TruScreen needs no laboratory infrastructure • TruScreen is targeted to developing countries.

4. OUR MARKETS

5. ROAD TO COMMERCIALISATION 2017: CURRENT STAGE OF COMMERCIAL JOURNEY RESEARCH AND DISTRIBUTION AWARENESS AND ADOPTION AND INITIAL MATURE SALES DEVELOPMENT PARTNERSHP ACCEPTANCE SALES • Development of first • Identify and partner • Build awareness and • Initial sale of TruScreen • Increasing device sales and second generation with a reputable acceptance of TruScreen devices • Ongoing, repeat sale of devices and algorithm distributor, which has • Rollout of commercial • Low initial usage of an existing network and Single Use Sensors as • Clinical validation contacts in country programme Single Use Sensors per usage per device device increases • Adoption by Key • Building usage as Doctor Opinion Leaders and patient acceptance • Clinical trials and in- grows market validation • Presentation at major conferences and congresses

6. OUR COMMERCIAL PROGRESS IN PAST TWO YEARS  Re-certified TruScreen1 and sold all TruScreen1 Inventory KEY FINANCIALS FY17  Created and certified TruScreen2 – provides a significant improvement in Sales 585,388 performance, speed and capability  Establishing our global footprint: Distribution agreements in place in 24 countries, Other income 810,202 with key focus on China, Mexico, Russia, India and Europe/Middle East Revenue from Ordinary Activities 1,395,590  Establishing new manufacturing capabilities Net Loss (3,540,610)  Gaining support from Key Opinion Leaders  Completed a number of in-market clinical trials with overwhelmingly positive results Net Assets 14,324,288  Close to completion on TruScreen Algorithm Improvement Programme Cash and Cash Equivalents 3,671,571

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

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

7.2 REGULATORY APPROVAL IN SELECTED COUNTRIES  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

7.3 GOVERNMENT SCREENING PROGRAMMES 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

7.4 GLOBAL DISTRIBUTION NETWORK 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

7.5 ENHANCE SALES  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

FY18 Goals and Strategic Progress 8. OUR MARKETS

8.1 CHINA CHINA: THE FACTS  Major new sub distributor (Bio-Chem) appointed to manage government sales channels  400 million women of screening age  10 county hospitals conducting Centre for Disease Control evaluation – 30,000  Initial distribution agreement signed 2014 community healthcare centres throughout rural China  28% of FY17 TruScreen sales  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.

8.2 MEXICO • Clinical Trial showed TruScreen more than twice as sensitive as pap in identifying high MEXICO: THE FACTS grade cervical changes (CIN2+)  31 million women of screening age Working on the following activities:  Distribution agreement signed 2015 • Endorsement by National Cancer Institute – Stage 2, 400 patients, to commence in October  20% of FY17 TruScreen sales • 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)

8.3 INDIA AND RUSSIA INDIA: THE FACTS RUSSIA: THE FACTS  300 million women of screening age  44 million women of screening age  Distribution agreement signed 2017  Distribution agreement signed 2015  Sales commencing in FY18  Sales increasing in FY18   Engaged major distributor – KLAB, with 700 Prof Rogowskaya included TruScreen in draft employees screening recommendations for the All Russia Society of Obstetricians and Gynaecologists  Finalised protocols and arrangements for the  commencement of Stage 1 of the Indian Preparing submission for TruScreen to be used in Government (BIRAC) evaluation of TruScreen to Moscow non-metropolitan screening program seek endorsement for inclusion in the 2019 (potential is 500,000 women) National Ministry of Health budget  Cleared all import and other regulatory requirements to sell TruScreen in India

8.4 OTHER MARKETS MIDDLE EAST: EUROPE AND CENTRAL ASIA: THE FACTS THE FACTS  Agreements signed 2016 – Iran, Iraq Jordan,  Distribution agreements signed 2016/17 – Saudi Arabia, UAE, Turkey Turkey, Poland, Croatia, Slovenia, Bosnia- Herzegovina, Kosovo, Serbia, Montenegro,  51 million women of screening age Germany, Switzerland, Austria, Ukraine, Kazakhstan • 9% of FY17 TruScreen sales  90 million women of screening age  43% of FY17 TruScreen sales • Distribution footprint covers seven countries, including Iran (Russia included) and Iraq • Establishing KOL support and government endorsement  Distribution footprint covers 14 countries prior to commercial roll out • Seeking health insurance reimbursement approval in  Establishing KOL support and government endorsement multiple markets prior to commercial roll out