24 Nov

GTG Annual General Meeting Presentation

Annual General Meeting Chief Executive Officer Presentation November 24, 2021 Authorised by the Board of Directors of Genetic Technologies Limited ASX: GTG NASDAQ: GENE Notice: Forward looking statements The purpose of the presentation is to provide an update of the business of Genetic Technologies Limited (the Company) ACN : 009 212 328 (ASX : GTG ; NASDAQ : GENE) . These slides have been prepared as a presentation aid only and the information they contain may require further explanation and/or clarification . Accordingly, these slides and the information they contain should be read in conjunction with past and future announcements made by the Company and should not be relied upon as an independent source of information . Please refer to the Company’s website and/or the Company’s filings to the ASX and SEC for further information . The views expressed in this presentation contain information derived from publicly available sources that have not been independently verified . No representation or warranty is made as to the accuracy, completeness or reliability of the information . Any forward looking statements in this presentation have been prepared on the basis of a number of assumptions which may prove incorrect and the current intentions, plans, expectations and beliefs about future events are subject to risks, uncertainties and other factors, many of which are outside the Company’s control . Important factors that could cause actual results to differ materially from assumptions or expectations expressed or implied in this presentation include known and unknown risks . Because actual results could differ materially to assumptions made and the Company’s current intentions, plans, expectations and beliefs about the future, you are urged to view all forward looking statements contained in this presentation with caution . This presentation should not be relied on as a recommendation or forecast by the Company . Nothing in this presentation should be construed as either an offer to sell or a solicitation of an offer to buy or sell shares in any jurisdiction . Significant progress has been made in understanding the role of hereditary risk in chronic disease, however, many chronic conditions cannot be predicted by this risk alone. We’re transforming the conversation. Transitioning from a one - size - fits - all model to personalised, predictive health assessment – where each person has the information, they need to manage their health according to their own risk. Backed by over 20 years of experience, our doctors, scientist and technicians are translating genetic information into multi - tests that uniquely combine genetic and clinical risk models to predict risk of chronic diseases before onset. We’re empowering physicians to improve health outcomes for people around the world. Tracking disease to its source. Enabling a new era of personalised medicine. Unlocking personalised preventative health 01 02 03 04 05 2021 Overview Where are we now Our Vision & Brand Pillars Prioritising the market entry strategy by region Our Markets EasyDNA - Building our Direct - to - Consumer growth pathway Our Acquisition Focused on three distinct and target routes to market Our Channels & Divisions Executing through cutting edge innovation and ‘game changing’ partnerships Our Portfolio & Innovation Our Overview 4 06 Aligning our internal capability aligned to execution Our Capabilities Highlights and Results overview – Qtr. 1, 2021 89 850 Full Year FY21 Actual Q1 FY22 Actual A$'000 Receipts from Customers • Cash receipts of A$850k, a material increase on the prior quarter • Acquired, settled and integrated the acquisition of EasyDNA, the primary channel for the increase in cash from operations, for US$4 million in cash and scrip • Completed and submitted NATA validation pack for the Multi - Test; final step prior to the commercial launch of the Multi - Test • Invested in self - funded collaborative study to enable expanded Breast Cancer risk testing for populations of African descent with Professor Colditz at Washington State University • Published peer - reviewed paper titled “Ability of known colorectal cancer susceptibility SNPs to predict colorectal cancer risk: A cohort study within the UK Biobank” Gafni A, Dite GS, Spaeth Tuff E, Allman R, Hopper JL (2021) on PLoS • Strong cash balance of A$15.7 million, providing 24 months of runway post the integration and revenue contribution from EasyDNA • Net cash used for operations of A$1.9 million, due mainly to the increase in R&D and operating expenses as the Company executes on its commercialisation strategy Results as published on the ASX Monday October 4, 2021 01: Our 2021 Snapshot License and distribution agreement for COVID - 19 Risk Test with IBX Launched CIT in USA & AUS for other tests 1 Signed multi - year distribution agreement Over a decade of R&D translating to commercial launch of geneType for Breast Cancer, Colorectal Cancer & COVID - 19 African American Breast Cancer Research Collaboration with Professor Colditz at Washington State University Focused on commercialisation of R&D Acquired EasyDNA for US$4m in cash and script 2 providing global platform with US$4.63m in unaudited revenue in CY20 Acquired revenue generating platform A$15.7million cash balance following settlement of EasyDNA, providing a 24 - month runway 2 Solid balance sheet 17 patents granted and 9 patent families pending multiple peer - reviewed publications and four collaborations with prestigious academic and medical establishments Robust patent portfolio & clinical credibility New Multi - test development on track for serious disease risk including major oncological, metabolic and degenerative diseases - covering up to 70% of mortalities and morbidities On track to launch new Multi - test 1. geneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform. 2. Runway based on current cash projections and including the acquisition of EasyDNA Australia & New Zealand Certification by Australian regulators NATA , to sell into the Australian market Two products 1 currently certified and further products expected to be submitted in next 12 months Asia (Inc. SEA, China and India) H2 CY2021 to commence a scoping and Prioritising a market entry strategy into Asia EasyDNA available in multiple countries across SEA Europe & UK Commencing CE certification enabling EU launch of Novel genetic risk test in CY2021 EasyDNA available multiple EU countries and UK United States geneType® Polygenic Risk Score (PRS) tests for breast, colorectal cancer and COVID - 19 Risk Test available through CLIA Certified “High Complexity” Laboratories. Further products expected to be submitted in next 12 months 1 GeneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform. 02: Our Markets and Collaborators 02: A strategy to own the personalised, preventative health testing market Demonstrating our leadership by informing the conversation on personalised, preventative health care Thought leadership Amplifying our impact by starting and informing conversations in key consumer and clinical channels Seeded content Core set of sales and marketing tactics and assets tailored by therapeutic area, and adapted by geography Sales & marketing Motivating trial and purchase with medical education for clinicians and consumers Medical education Brand Recognition and Advocacy Commercialization and Branding Empowering clinicians to use geneType. Their clinic becomes a geneType Hub that taps into a GP referral network and reinforcing their leadership in personalised, preventative health geneType Hubs Building a group of clinicians and consumers willing to share with their colleagues and friends their experience with geneType geneType advocacy 02: A cutting - edge geneType brand set for relaunch Mobile Digital Education 02: Core set of sales material to empower clinicians and consumers to trial and use geneType tests Patient case studies Clinical Summaries At - a - glance brochure HCP Guide Book Management guide Expert interviews Patient booklet Clinic poster 03: EasyDNA – Acquisition of DTC Platform • Acquired EasyDNA in August 2021 for US$4 million • Current revenues of US$4.63 million through retail sales of its at - home DNA tests • Agreements with 12 laboratories in North America, AsiaPac and Europe • A platform to launch the geneType Multi Test and portfolio of serious disease tests across 40 countries* * Subject to local regulatory requirement 03: EasyDNA – Establishing our Lifestyle Division • Headed by Kevin Camilleri • EasyDNA currently sells paternity, oncology and health and wellbeing genomics - based tests • This acquisition provides Genetic Technologies the foundation to grow in 40 countries • Expand the health - related tests with an extensive DTC marketplace Consumer initiated testing (CIT) with medical supervision Launched US and Australia CIT platforms in 2020 with medical supervision with: InTeleLabs in the US Phenix Health in Australia Current products include: geneType for Breast Cancer geneType for Colorectal Cancer AUD$349 / US$249 per test Direct to consumer testing (DTC) with no medical supervision Recent Acquisition announced for EasyDNA Leverage for paternity, ancestry, gut microbiome testing and non - medical related genomic tests www.Easydna.com Provides Genetic Technologies the foundation to grow in 40 countries Agreements with 12 laboratories in North America, AsiaPac and Europe Medical – Business to Business (B2B) A communication and execution plan curated for Payers / Insurers* Primary Care Physicians Specialists Surgeons Allied Health Certifying reimbursable germline testing platform BRCA test LYNCH Syndrome test (More to follow)* ` ` * Corporates and Insurance market entry assessment in progress. 04: Our Pathways Emerging divisions Existing divisions 04: Our Divisions Lifestyle Ancestry and Microbiome Oncology BC, CRC, PC, Melanoma Metabolic d iseases Diabetes Pharmoco - Genetics & Companion diagnostics Germline t esting BRCA, Lynch Syndrome and Somatic testing Mental Health by Taliaz CVD (Heart Disease) IHD, AF COVID - 19 Serious disease risk (SDR) BC = Breast Cancer; CRC = Colorectal Cancer; PC = Prostate Cancer; CVD = Cardiovascular Disease; IHD = Ischemic Heart Diseas e; Atrial Fibrillation NEW Universal sample collection kit with TGA, FDA and EU regulatory approval 1 NEW – Universal collection test kit to support Multi Test Launch 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek Breast Cancer (BC) 1 Colorectal Cancer (CRC) 2 Chronic Heart Disease (CHD) 3 Low polygenic risk score High polygenic risk score geneType detects patients at an actionable risk of serious disease 10 – 15 years earlier than currently possible Potentially significantly improving patient outcomes and health economics 1 Mavaddat et al. (2015) JNCI. 2 Jenkins et al. (2019) Familial Cancer. 3 Abraham et al. (2016) Eur Heart J. 05: Our Innovation geneType integrates genetic risk and clinical risk to better stratify individual risk. Patients with potentially high risk m ay exceed actionable clinical guidelines 10 – 15 years earlier than those with low risk 1,2,3 05: Our Portfolio - Driving Growth 16 December 2020 April 2021 July 2021 H2 2021 Market Release to include up to 70% of morbidity : • Breast Cancer • Colorectal Cancer • Cardiovascular Disease • Type 2 Diabetes • Ovarian Cancer • Prostate Cancer Multi Test to provide risk assessment for >70% of all morbidities to launch Commercially 1 Available Q4 CY 2021 ` ` Moderate Revenue Expectations Q2 CY 2021 100% Germline + PRS test for Breast Cancer and CRC to launch in AU & USA BRCA Panel Lynch Syndrome Commercially 1 Available Q4 CY 2021 Expanding into reimbursable space IBX COVID Risk Test released for sale May 31, 2021 Revenue Commenced Q2 CY 2021 CIT Platform in AUS and USA selling BRC and CRC 1. Subject to regulatory approval 05: Significant market opportunity 17 281,550 5 Diagnosis of breast cancer annually in United States 1 st degree relatives To provide predictive, pre - symptomatic testing to inform lifestyle choices and healthcare discussions Guideline driven, reimbursable for inherited and non inherited disease 149,500 6 Diagnosis of colorectal cancer annually in United States 1 st degree relatives Global Predictive Genetic Testing Market anticipated to exceed $28bn by 2026 1 1. Genetic Testing Market Size By Test Type (Predictive Testing, Carrier Testing, Prenatal and New - born Testing, Diagnostic Testing , Pharmacogenomic Testing, Nutrigenomic Testing), By Application (Cancer, Genetic Disease, Cardiovascular Disease), Industry Ana lysis Report, Regional Outlook, Application Potential, Competitive Market Share & Forecast, 2020 – 2026; Published Date: Feb 2020; Authors: Sumant Ugalmugle, Rupali Swain 2. PRS = Polygenic Risk Score 3. https://www.canceraustralia.gov.au/affected - cancer/cancer - types/breast - cancer/breast - cancer - australia - statistics 4. https://www.canceraustralia.gov.au/affected - cancer/cancer - types/bowel - cancer/bowel - cancer - colorectal - cancer - australia - statistics 5. https://www.cancer.org/cancer/breast - cancer/about/how - common - is - breast - cancer.html 6. https://www.cancer.net/cancer - types/colorectal - cancer/statistics BRCA Panel + Breast Cancer PRS Testing providing up to 100% genetic risk cover screening Near Term Addressable Market LYNCH Syndrome Panel + Colorectal Cancer PRS Testing providing up to 100% genetic risk cover screening GTG Target Market for GTG Target Market for (15,494 cases diagnosed annually in Australia 4 ) (19,974 cases diagnosed annually in Australia 3 ) 05: Our Innovation - Multi Test A companion diagnostic PRS to help identify risk of serious disease for up to 70% of Mortalities and Morbidities Committed to continually invest in developing multi population testing solutions 1 2 3 4 Oncology Breast Cancer Colorectal Cancer Prostate Cancer Melanoma Pancreatic Cancer Ovarian Cancer Cardiovascular Atrial Fibrillation Coronary Artery Disease Metabolic Type 2 Diabetes Mental Health Taliaz NEW Universal sample collection kit with TGA, FDA and EU regulatory approval 1 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek 2. Commercial availability expected Q4 CY2021 3. Commercial availability expected Q1 CY2022 Phase 1 Launch 2 Phase 2 Launch 3 GeneType Multi - test to include >70% of mortality & morbidity 05: Our Innovation - Multi Test Phase 1 Launch Test reports – NATA Validation pack submitted 1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek 2. Commercial availability expected Q4 CY2021 3. Commercial availability expected Q1 CY2022 Phase 1 Launch 2 Phase 2 Launch 3 Enhanced Sales and Distribution Capitalise on Licensing, JV and M&A opportunities Partner with leading commercial labs in regions Dedicated Innovation Hub Developing and capturing the next generation of innovation in genomics Enhanced IT infrastructure Futureproofing our platform Commercial Finance Innovation underpinned by controlled operating expenditure Education and Advisory Leveraging partnerships with institutions Oversight and advise to guide ethics and inform innovation Internal Structure Resourced to deliver with significant medical and business acumen inhouse to continue to drive value Marketing and Positioning Creating a consumer and patient led infrastructure for a direct to consumer e - commerce and B2B sales platform Ge n etic based preventative health platform 06: Our Capability 01 02 03 04 05 Our Vision & Brand Pillars Our Markets Our Acquisition Our Channels & Divisions Our Portfolio & Innovation 21 06 Our Capabilities Targeted and deliberate Focused and distinct Cutting edge innovation Positioned for growth Aligned to execute Thank you Investor Relations and Media (US) Dave Gentry Red Chip Cell: +1 407 491 4498 1 800 RED CHIP (733 2447) dave@redchip.com Investor Relations - AUS Stephanie Ottens Market Eye +61 434 405 400 stephanie.ottens@marketeye.com.au Appendices 7 Patents granted in the US • Patent 11,031,098, Computer systems and methods for genomic analysis • Patent 10,683,549, Methods for assessing risk of developing breast cancer • Patent Nos. 9,051,617; 9,068,229 and 9,702,011 covering three of the core genetic markers included in the BREVAGenplus® risk assessment test • Patent No. 7,127,355 offering broad protection re: methods of genetic analysis (the concept of combining clinical risk assessment with genetic risk factors to improve predictability over clinical risk assessment alone) • Patent No. 6,969,589 covering the identification of informative SNPs 5 Patents granted in China • Patent Nos. 200680051710.0; 201310524782.4; 201310524916.2 and 201310524765.0 “Markers for Breast Cancer” • Patent No. 201080033130.5 Methods for Breast Cancer Risk Assessment 5 Patents granted in Hong Kong • Patent Nos. 09101235.4; 12112875.1; 12112368.5 and 12112874.2 “Markers for Breast Cancer” • Patent No. 12109000.5 Methods for Breast Cancer Risk Assessment 9 Patent families pending • Methods for breast cancer risk assessment • Methods for assessing risk of developing breast cancer • Improved methods for assessing risk of developing breast cancer • Markers for breast cancer • Methods for genetic analysis • Methods for genomic analysis • Methods for assessing risk of developing colorectal cancer • Methods of assessing risk developing a disease • Methods for assessing risk of developing a severe response to coronavirus infection Our Intellectual Property Dr. Lindsay Wakefield MBBS Non – Executive Director Mr. Peter Rubinstein BEc, LLB Chairman - Non – Executive Director Dr. Jerzy “George” Muchnicki MBBS Executive Director & Chief Medical Officer Mr Nick Burrows B.Com, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director Simon Morriss GAICD Chief Executive Officer Richard Allman BSc, PhD Chief Scientific Officer Mike Tonroe BSc, FCA, MAICD Chief Financial Officer Carl Stubbings Chief Commercial Officer Erika Spaeth PhD Director of Clinical Affairs & Medical Education Board and Management: Sales and Scientific expertise leading GTG Professor Jon Emery MBBCh MA DPhil FRACGP MRCGP Research & Education Lead, Primary Care Integration, Victorian Comprehensive Cancer Centre Herman Chair of Primary Care Cancer Research, University of Melbourne Professor Finlay Macrae AO MBBS, MD, FRACP, FRCP, AGAF MWGO is Principal Fellow and Professor, Department of Medicine, University of Melbourne, and Head of Colorectal Medicine and Genetics, The Royal Melbourne Hospital Ora K. Gordon, M.D. MD, MS, FACMG Regional Medical Director, Center for Clinical Genetics & Genomics. Clinical Director, PSJH Population Health Genomics Program. Chair, Integrated Network Cancer Program, Professor of Genetics, St John Cancer Institute Strong Scientific Leadership: Advisory Board Financial Overview • Cash burn of A$1.94 million a decrease on prior quarter (Q4 FY’21: A$2.12 million) as a result of product sales, mainly from the EasyDNA brand • Cash reserves of A$15.7 million after EasyDNA acquisition costs of A$3.5 million give 24 month runway to: • Support the introduction and distribution of new geneType products in the United States and Europe • Develop the direct - to - consumer sales channel through EasyDNA • Reimbursement studies for the polygenic risk tests; • Introduction of germline testing division; • General product research and development; and • For general working capital and potential acquisitions. $A’000 30 June 2021 30 Sep 2021 Change Net operating cashflow (2,116) (1,939) 8% Receipts from customers 850 68 92% Research and Development and Staff costs 1,215 1,321 (9%) Cash 20,903 15,742 (25%) BNY Mellon , 74% Board & Management , 6% Other , 20% Top 50 share registry breakdown Financial Information Share price (AUD) as at 23 November 2021 0.6c ADR price (USD) as at 23 November 2021 $ 2.44 Ord Shares on Issue (M) 9,233 ASX 52 - week trading (AUD low/high) 0.6/1.4c Nasdaq 52 - week trading (USD low/high) 2.26/8.18 Market Cap (A$M/US$M) 55.36/39.62 Cash at 30 June 2021 A$20.9m Cash at 30 September 2021 A$15.7m Debt (30 June and 30 September 2021) nil Dual Listed on the ASX and Nasdaq Corporate Overview Defined Terms Common Complex Diseases (CCP) – A complex disease is caused by the interaction of multiple genes and environmental factors. Complex diseases are also called m ultifactorial. Examples of common complex diseases include cancer and heart disease. Polygenic risk score - a number associated with one’s disease risk based on the aggregated effects of individual risk variants through a multiplicat i ve algorithm. Variant - Single Nucleotide polymorphism (SNP), an alteration in DNA that may be a common or rare event. Genomic - pertaining to function of genetics from structure to relationship between genetic events. Genetic - pertaining to a gene. GWAS - genome - wide association studies are large population level studies which enable scientists to identify genes and genetic markers involved in human disease. This method searches the genome for SNPs that occur more frequently in people with a particular di se ase than in people without the disease. Each study can look at hundreds or many thousands of SNPs at the same time. Researchers use data fro m this type of study to pinpoint genetic variations that may contribute to a person’s risk of developing a certain disease. SNP - Single nucleotide polymorphisms, frequently called SNPs (pronounced “snips”), are the most common type of genetic variation a mon g people. Each SNP represents a difference in a single DNA building block, called a nucleotide. For example, a SNP may replac e t he nucleotide cytosine (C) with the nucleotide thymine (T) in a certain stretch of DNA. Serious Disease Risk (SDR) - Risk associated with acquiring COVID - 19 and requiring hospitalisation withs its associated morbidities and mortalities. Germline Testing – Germline testing is done on cells that do not have cancer. It is done to see if a person has a gene mutation that is known to increase the risk of developing cancers and other health problems. This test uses cells (such as blood or skin cells) that do no t have any cancer cells. Germline mutations can sometimes be passed down from parents. Clinical Laboratory Improvement Amendments (CLIA) - Regulates laboratory testing and require clinical laboratories to be certified by the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing National Association of Testing Authorities (NATA) - the authority responsible for the accreditation of laboratories, inspection bodies, calibration services, producers of certified reference materials and proficiency testing scheme providers throughout Australia. It is also Australia's compliance monitoring authority for the OECD Principles of GLP. NATA provides independent assurance of technical competence t hro ugh a proven network of best practice industry experts for customers who require confidence in the delivery of their products an d services. Next Generation Sequencing ( NGS) – Next - generation sequencing (NGS), also known as high - throughput sequencing, is the catch - all term used to describe a number of different modern sequencing technologies. These technologies allow for sequencing of DNA and RNA much more quickly and cheaply than the previously used Sanger sequencing, and as such revolutionised the study of genomics and molecula r b iology. Laboratory Developed Tests (LDT) – A type of in vitro diagnostic test that is designed, manufactured and used within a single laboratory. Consumer Initiated Tests (CIT) - laboratory testing that is initiated by the consumer without a physician order but reviewed and communicated back to the consumer via a physician. Direct to Consumer (DTC) – laboratory testing that is initiated by the consumer without a physician order. The results are reported back directly t o the consumer.
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