Forward Looking Statements

Transcription

1 June 2015

2 Forward Looking Statements This presentation may contain forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933 and Section 21E of the U.S. Securities Exchange Act of 1934 with respect to the financial condition, results and business achievements/performance of Genetic Technologies Limited and certain of the plans and objectives of its management. These statements are statements that are not historical facts. Words such as should, expects, anticipates, estimates, believes or similar expressions, as they relate to Genetic Technologies Limited, are intended to identify forward-looking statements. By their nature, forward-looking statements involve risk and uncertainty because they reflect Genetic Technologies current expectations and assumptions as to future events and circumstances that may not prove accurate. There is no guarantee that the expected events, trends or results will actually occur. Any changes in such assumptions or expectations could cause actual results to differ materially from current expectations. 2

3 Company Overview Commercial-stage molecular diagnostics company focused on women s health and risk assessment BREVAGenplus and BREVAGen TM breast cancer risk tests for nonfamilial (sporadic) breast cancer is commercially available Approved and available in all 50 U.S. States U.S. CLIA approved and CE Marked BREVAGenplus, launched in Oct. 2014, expands application to Hispanic and African-American women Allows physicians to recommend personalised Breast Health Plan 8.6 MM women in U.S. comprise potential target market 235,000 breast cancer cases are diagnosed each year in the U.S. 85% of breast cancer cases, are sporadic (meaning no strong family history) Dual-listed on NASDAQ (GENE) and ASX (GTG) 3

4 Key Senior Management Eutillio Buccilli, Executive Director & Chief Executive Officer Joined in Jun. 2014, as CFO, appointed CEO in Feb and Executive Director in Jun years of senior management experience with GE, CSC, Coles Myer and Challenger Limited Extensive financial and commercial experience in Australia and U.S. Brian Manuel, Chief Financial Officer Joined in Jun. 2015, as CFO, Mr. Manuel is a Fellow Chartered Accountant and a Fellow of the Governance Institute of Australia 25+ years of experience, with more than a decade at CFO level for companies listed on the ASX including, Biotech Company, Cellestis Ltd. Has broad business acumen, in addition to his strong foundation in finance, IT and corporate governance Richard Allman, PhD, Scientific Director 20+ years of scientific and research experience in the UK and Australia Most recently responsible for providing scientific and technical guidance for the launch of the BREVAGen and release of the BREVAGenplus risk assessment test in the U.S. and managing associated research programs Academic career encompassed oncology research, drug development and assay design, with a particular interest in the linkage between onco-genetic profile and treatment response Mark J. Ostrowski, President, Phenogen Sciences Inc. (U.S. subsidiary of Genetic Technologies) Joined in Sept. 2012, as Senior VP Sales/Marketing, appointed President Sales/Marketing in Dec years of sales and marketing experience in molecular diagnostics (including Director of Sales Operations at Myriad Genetics and Director of Managed Care Services at DIANON Systems Academic tenure in the specialized molecular diagnostics space and led successful commercialization and clinical adoption and reimbursement of now standard-of-care clinical molecular diagnostic assays used in the diagnosis and management of cancer 4

5 BREVAGenplus

6 TV Segment 6

7 What is BREVAGenplus? Simple swab-based test that helps determine a woman s risk of developing breast cancer Genetic risk is combined with clinical risk from the NCI s Breast Cancer Risk Assessment Tool ( BCRAT ) to provide an integrated risk score Molecular panel of over 70 SNPs (single nucleotide polymorphisms) identified from the Human Genome Project Found in 25-50% of women, these SNPs are high frequency/low penetrance alleles First test of its kind to be clinically validated to assess both 5-year and lifetime risk for sporadic breast cancer: both hormone-dependent and triple negative subtypes Validated and CLIA-approved for use in Caucasian women of European descent, Hispanic and African women aged 35 BREVAGenplus Our flagship first-in-class risk assessment test for non- hereditary breast cancer 7

8 Early Detection Is Key 1 in 8 U.S. women will develop breast cancer in her lifetime 39,500 of these women will die each year HOWEVER, with early detection, >95% of these women can survive* Breast Cancer Develops Before It is Detected 8 *

9 Familial vs. Sporadic Breast Cancer 235,000 breast cancer cases are diagnosed each year in the U.S. 85% of breast cancer is sporadic (meaning no strong family history) - An estimated 188,000 sporadic cases are reported each year BREVAGenplus focuses exclusively on risk for sporadic breast cancer Women who are BRCA negative, with no/limited family history, who may have an elevated clinical risk 9

10 BCRAT/Traditional GAIL Score Traditionally, a patient s risk of sporadic breast cancer has been identified by using clinical factors alone Historically known as the GAIL score, the Breast Cancer Risk Assessment Tool ("BCRAT"), developed by the NCI, measures a woman s hormonal and reproductive risk factors, including: Pregnancy history Current age Age at menarche Age at menopause Race/ethnicity 10

11 Differentiated Integrated Risk Score BREVAGenplus provides both a 5-year and lifetime percentage risk of developing sporadic breast cancer Allows physicians to recommend a personalised Breast Health Plan outlining better surveillance strategies and proactive changes, tailored to each patient s lifestyle and health status Provides medical management options based on independent guidelines from the American Cancer Society and ASCO (last updated 2009) 11

12 BREVAGenplus Clinical Difference 12 Early detection of breast cancer is the key to successfully fighting it - BREVAGenplus enables more accurate selection of patients for MRI screening - Less than 50% of women maintain regular mammographic screening * - BREVAGenplus helps solve the over/under use of the mammography debate by tailoring the right schedule for the right risk profile USPSTF (April 2013) recommends the use of tamoxifen/raloxifene in high risk women - BREVAGenplus can provide the information required to justify tamoxifen use Recent legislation requires MDs to notify patient of dense breast tissue following mammography - BREVAGenplus is an appropriate test for patients identified as having dense breast tissue * Gierisch JM, et al. (2010). Cancer Epidemiol Biomarkers Prev. 19:

13 Scientific Support for BREVAGenplus Mealiffe ME, et al. (2010). J Natl Cancer Inst. 102(21): Assessment of clinical validity of a breast cancer risk model combining genetic and clinical information Confirms the validity of combining SNP genotypes with the Gail model and demonstrates the utility of reclassification analysis for predictive risk tests. Comen E, et al. (2011). Breast Cancer Res Treat. 127: Discriminatory accuracy and potential clinical utility of genomic profiling for breast cancer risk in BRCA-negative women Provides independent confirmation of the validity of combining SNP genotypes with the Gail model. Demonstrates the clinical utility of improved risk assessment for guiding MRI screening and Tamoxifen chemoprevention. Dite GS, et al. (2013). Breast Cancer Res Treat. 139(3): Using SNP genotypes to improve the discrimination of a simple breast cancer risk prediction model Extends reclassification of breast cancer risk using SNP genotypes to a wider population age group. Folse H, et al. (2013). Cancer Prev Res. 6(12): Cost-effectiveness of a genetic test for breast cancer risk Simulated clinical trial demonstrates that use of BREVAGenplus to recommend MRI screening is most cost-effective for women with a lifetime risk between 16% and 28%. Importantly, this strategy is predicted to reduce breast cancer deaths by 2.66% (relative to Gail alone). Green, et al. (2014). Applied Health Econ Health Policy. 12(2): Economic Evaluation of Using a Genetic Test to Direct Breast Cancer Chemoprevention in White Women with a Previous Breast Biopsy. Simulated clinical trial demonstrates BREVAGenplus is most cost-effective for women with a pre-test breast cancer 5-year risk of %. Results demonstrated combining genetic susceptibility data with current breast cancer risk models used to guide chemoprevention recommendations improves clinical outcomes and is cost effective. 13

14 Reimbursement & Business Model Claims submitted to insurers via a miscellaneous CPT code Contracts exist with 8 PPOs (including MultiPlan) which facilitate claim processing and payment Do not claim from Medicare/Medicaid an international lab; not the target demographic Negotiations to contract with Insurers directly, will commence once supporting clinical utility studies published mid to end calendar 2015 Recoverability at 65% - with average revenue per test recovered, approximately USD470 cents) Gross Margin is >95% on list price; and >75% on average payment received 14

15 Intellectual Property Patents submitted in U.S. cover: Granted US Patent Nos. 9,051,617 and 9,068,229 covering three of the core genetic markers included in the BREVAGenplus risk assessment test Broad protection for the concept of combining clinical risk assessment with genetic risk factors to improve predictability over clinical risk assessment alone First generation BREVAGen test, comprising up to 10 SNPs plus clinical model (Gail) Second generation BREVAGenplus test, comprising a minimum of 77 SNPs plus a clinical model (GAIL or Tyrer-Cuzik or BOADACEA) 15

16 Market Opportunity and Commercial Status

17 Market Opportunity Total number of women in target age range for BREVAGenplus: 54.3 million Potential market size reduced by: Ethnicities not covered by BREVAGenplus ~10% Women on Medicaid ~20% Of which ~33% Women of intermediate risk, based on GAIL score Total target population ~12.9 million BUT: CDC shows only 67% compliance for mammography in eligible age groups Thus potential market size ~8.6 million women 17

18 Targeted Patient Profile With a focus on OB/GYN clinics and Breast Health Centers, appropriate candidates for BREVAGenplus, include: Caucasian women of European descent (based on current test, BREVAGen) expanded to include Hispanic and African American women with the release of BREVAGenplus Age 35 years Gail-model appropriate Other clinical risk factors (high breast density, BMI 30) Women who return a negative breast biopsy result Women with above average clinical lifetime risk 18

19 Status of Commercialisation Roll-Out Commercial infrastructure for the U.S. Market is well established through wholly-owned U.S. Subsidiary, Phenogen Sciences: 19

20 Market Progress BREVAGenplus now available in all 50 U.S. states Samples received from 18 high population density territories 8,558 Samples received since launch of BREVAGen, in June 2011, BREVAGenplus released in October Key Opinion Leaders (KOLs) act as BREVAGenplus Ambassadors to: Highlight the utility and value of BREVAGenplus in the clinical setting Provide templates for clinic adoption, patient selection and logistics Drive increased adoption of the BREVAGenplus test High prescribing users and KOLs on U.S. regional TV aim to: Introduce BREVAGenplus to the general public Integrate PR with new speakers in the various sales markets 20

21 Performance - June fiscal year end 21 8,558 samples received since BREVAGen was launched in June 2011; BREVAGenplus launched in October 2014

22 Geographical Cluster of Samples Cumulative U.S. Samples cluster - July 2011 to June U.S. sales team focus on territories with high volume, demonstrating strong growth potential

23 Key Drivers for Market Adoption Scientific validation and clinical utility studies 23 Further scientific validation results/publications expected by end Q1 FY16 Evidence from clinical utility studies will secure wider payer coverage, increase current reimbursement levels and speed product uptake first of three trials to begin Q2 FY16, completion expected end FY16 Market awareness KOL speaker program Integrated web/social media Targeted regional media features Key accounts Focus on breast/imaging centers Find, establish, grow Reimbursement Commence discussions with insurer groups once clinical utility studies provide evidence that demonstrate test impact on treatment decisionmaking that is aligned with payer evidence requirements

24 Competitive Landscape The limited, if any, competition to BREVAGenplus, includes: decode (Iceland) Launched in October 2008 by decode Genetics, but with no validation decode Breast Cancer test assesses risk based on 16 common SNPs, ordered only via MDs Emerged from Chapter 11 in April 2010 as a private company purchased by Amgen in December 2012 (US$415 million), primarily for companion diagnostics assets Other (largely direct to consumer) Navigenics (FDA warning letter received and test subsequently withdrawn from the market) Acquired by Life Technologies (ThermoFisher) July 2012, part of expansion into oncology diagnostics 23&Me (FDA warning letter received and test subsequently withdrawn from the market) Knome (supply Genomic Interpretation Algorithms) Halo Nipple Aspirate Test (Halo Healthcare) 1. discomfort to patients 2. little supporting evidence MASCAT (Atossa Genetics) 1. FDA Class 1 recall in September

25 Financial Snapshot

26 Financial Snapshot Fiscal Year Ended June 30 Financials Revenue (AUD millions) BREVAGen/ BREVAGenplus Shares as at 30 June 2015 Shares outstanding 1,714 MM ADRs ratio) 11.4 MM Top 20 shareholders 86.4% Total shareholders 3,165 Unlisted Options 24.2MM outstanding Market cap AUD48.0 MM 26

27 Contact Details Eutillio Buccilli Executive Director & Chief Executive Officer Phone Web: 27