ANNUAL GENERAL MEETING 2017 CHAIRMAN S ADDRESS

Transcription

1 ANNUAL GENERAL MEETING 2017 CHAIRMAN S ADDRESS

2 2. THE TRUSCREEN TEAM BOARD OF DIRECTORS Robert Hunter - Chairman Christopher Horn Independent Director Sean Joyce Independent Director Timothy Preston Independent Director LEADERSHIP TEAM Martin Dillon, CEO Dr Colin Stahel, Manager Marketing and Medical Technology Dr Jerry Tan, GM International Business Development Paul Curran, GM Quality and Regulatory James Haindl, Biotechnologist ADVISORY BOARD Prof. Neville Hacker AM Prof. Ronald Jones CNZM Dr Graham Pulford, Senior Algorithm Engineer Dr Akila Seneviratne, Algorithm Developer Dr Carolina Velasquez, Clinical Research and Training Officer Assoc Prof. Michael Campion Dr John Blakemore

3 3. THE OPPORTUNITY 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.

4 4. OUR MARKETS

5 5. ROAD TO COMMERCIALISATION 2017: CURRENT STAGE OF COMMERCIAL JOURNEY 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 inmarket validation 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 Presentation at major conferences and congresses

6 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 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 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

7 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

8 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%

9 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

10 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

11 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

12 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

13 FY18 Goals and Strategic Progress 8. OUR MARKETS

14 8.1 CHINA 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 CHINA: THE FACTS 400 million women of screening age Initial distribution agreement signed % of FY17 TruScreen sales 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.

15 8.2 MEXICO 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 MEXICO: THE FACTS 31 million women of screening age Distribution agreement signed % of FY17 TruScreen sales 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)

16 8.3 INDIA AND RUSSIA INDIA: THE FACTS 300 million women of screening age Distribution agreement signed 2017 Sales commencing in FY18 RUSSIA: THE FACTS 44 million women of screening age Distribution agreement signed 2015 Sales increasing in FY18 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 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) Cleared all import and other regulatory requirements to sell TruScreen in India

17 8.4 OTHER MARKETS 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) Distribution footprint covers 14 countries Establishing KOL support and government endorsement prior to commercial roll out 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 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

18 FY18 Goals and Strategic Progress 9. LOOKING FORWARD

19 9.1 FY18 PRIORITIES 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

20 FY18 Goals and Strategic Progress 10. BUSINESS OF THE MEETING SHAREHOLDER DISCUSSION

21 11. RESOLUTIONS 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.

22 FY18 Goals and Strategic Progress OTHER BUSINESS CLOSE OF THE MEETING Contact us for more information Martin Dillon Chief Executive Officer TruScreen Ltd T: E: martindillon@truscreen.com

23 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 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 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.