Skip to main content

AI assistant

Sign in to chat with this filing

The assistant answers questions, extracts KPIs, and summarises risk factors directly from the filing text.

GENETIC TECHNOLOGIES LIMITED Investor Presentation 2021

Jul 27, 2021

65022_rns_2021-07-27_91669e0a-24d2-4c47-987b-9c7f0303acfb.pdf

Investor Presentation

Open in viewer

Opens in your device viewer

==> picture [110 x 70] intentionally omitted <==

Investor Presentation and Webinar

Melbourne, Australia, 28 July 2021: Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”), a diversified Genomics and AI driven preventative health business provides the attached presentation and advises that the Company will be providing the following webinar for investors in Australia.

Thursday 29 July 2021 at 9:30am AEST/Wednesday 28 July at 7:30pm EST

To register please click on the link below. https://us02web.zoom.us/webinar/register/WN_ntdVwrJPQkeM0XszdzUvXQ

-END-

Genetic Technologies Limited 60-66 Hanover Street www.gtglabs.com Fitzroy Victoria 3065 [email protected] Australia ABN 17 009 212 328 +61 3 8412 7000

==> picture [78 x 49] intentionally omitted <==

Investor Relations (AUS) Investor Relations and Media (US) Stephanie Ottens Dave Gentry Market Eye 1 800 RED CHIP (733 2447) M: +61 434 405 400 Cell: 407 491 4498 E: [email protected] E: [email protected]

About Genetic Technologies Limited

Genetic Technologies Limited (ASX: GTG; Nasdaq: GENE) is a diversified molecular diagnostics company. GTG offers cancer predictive testing and assessment tools to help physicians proactively manage patient health. The Company’s lead products GeneType for Breast Cancer for non-hereditary breast cancer and GeneType for Colorectal Cancer are clinically validated risk assessment tests and are first in class. Genetic Technologies is developing a pipeline of risk assessment products.

For more information, please visit www.gtglabs.com

Genetic Technologies Limited 60-66 Hanover Street www.gtglabs.com Fitzroy Victoria 3065 [email protected] Australia ABN 17 009 212 328 +61 3 8412 7000

==> picture [267 x 540] intentionally omitted <==

==> picture [247 x 156] intentionally omitted <==

Investor Update July 2021

Authorised by the Board of Directors of Genetic Technologies Limited

==> picture [60 x 32] intentionally omitted <==

ASX: GTG NASDAQ: GENE

==> picture [60 x 32] intentionally omitted <==

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.

==> picture [60 x 32] intentionally omitted <==

Our Overview

03 01 02 04 05 06 Our Vision & Our Markets Our Channels & Our Portfolio & Our Acquisition Our Capabilities Values Divisions Innovation 2021 Overview Prioritising the Focused on three Executing through cutting EasyDNA - Building our Building our internal Where are market entry distinct and target edge innovation and ‘game Direct to Consumer capability aligned to we now strategy by region routes to market changing’ partnerships Growth pathway execution

3

==> picture [60 x 32] intentionally omitted <==

Our Vision & Values

To be the world’s leader in personalised predictive genetics

Collaborative

Cooperative, Receptive, Informative, Transparent

Unity and diversity drives us to make a positive impact on the community

Professional

Trustworthy, Respectful, Punctual, Accountable

Leveraging our collective skills and knowledge to create global partnerships

==> picture [365 x 379] intentionally omitted <==

Dynamic

Proactive, Striving, Responsive, Motivated.

Cutting edge Innovation that creates an aspirational place to work

Passionate

Enthusiastic, Inspiring, Dedicated, Energetic

A place where you can apply your skills and realise your career goals

==> picture [60 x 32] intentionally omitted <==

Our 2021 Snapshot

Multi-year distribution agreement

License and distribution agreement for COVID-19 Risk Test with IBX for minimum of US$2.9 million over 3 years to maintain exclusivity

A$21 million

Strong cash balance with 24 month runway[2]

Launched CIT in USA & AUS for other tests[1]

Strong focus on Commercialisation of R&D

Over a decade of R&D translating to commercial launch of geneType for Breast Cancer & Colorectal Cancer & COVID-19 Dedicated in-house scientific team

Up to 70% coverage

New Multi Test development on track for serious disease risk including major oncological, metabolic and degenerative diseases

Robust patent portfolio

17 patents granted and 9 patent families pending

Scientific & Clinical Credibility

Multiple peer-reviewed publications and four collaborations with prestigious academic and medical establishments

  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

==> picture [60 x 32] intentionally omitted <==

Our Markets and Collaborators

United States

Europe & UK

Asia

Australia & New Zealand

(Inc. SEA, China and India)

geneType® Polygenic Risk Commencing CE certification Score (PRS) tests for breast, enabling EU launch of Novel colorectal cancer and COVIDgenetic risk test in CY2021 19 available through CLIA Certified “High Complexity” Laboratories.

H2 CY2021 to commenced a scoping and Prioritising a market entry strategy into Asia

==> picture [90 x 110] intentionally omitted <==

==> picture [53 x 46] intentionally omitted <==

Further products expected to be submitted in next 12 months

==> picture [113 x 64] intentionally omitted <==

==> picture [54 x 37] intentionally omitted <==

==> picture [104 x 32] intentionally omitted <==

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

==> picture [84 x 29] intentionally omitted <==

1 GeneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform.

==> picture [60 x 32] intentionally omitted <==

Our Pathways

Medical – Business to Business Consumer initiated testing (CIT) Direct to consumer testing (DTC) (B2B) with medical supervision with no medical supervision A communication Certifying Launched US and Current products Recent Acquisition Provides Genetic and execution plan reimbursable Australia CIT include: announced for Technologies the curated for germline testing platforms in 2020 EasyDNA foundation to grow platform with medical geneType for Breast in 40 countries Payers / Insurers supervision with: Cancer BRCA test Primary Care InTeleLabs in the geneType for Leverage for Agreements with 12 Physicians LYNCH Syndrome US Colorectal Cancer Paternity, ancestry, laboratories in test gut microbiome North America, Specialists Phenix Health in AUD$349 / US$249 testing and non- AsiaPac and Europe (More to follow)* Australia per test medical related Surgeons genomic tests Allied Health www.Easydna.com

==> picture [39 x 34] intentionally omitted <==

==> picture [33 x 34] intentionally omitted <==

  • Corporates and Insurance market entry assessment in progress.

==> picture [60 x 32] intentionally omitted <==

Our Channels – B2B

Third Party Licensing

Provides enhanced distribution and product offering via:

  • Out licensing of own products for enhanced distribution opportunities (ie. Infinity BiologiX COVID-19 Risk Test)

  • In licensing of novel products for enhanced product offering (ie. PREDICTIX by Taliaz)

==> picture [197 x 159] intentionally omitted <==

Business to business sales via the medical profession

  • Adversely impacted by COVID-19 restrictions but remains a key avenue for education and sales

  • Combined with an educational program to target health professionals mediated by VR professional industry education content providers

Certifying reimbursable Germline testing platform anticipated to be completed by end of Q4 CY2021

==> picture [63 x 66] intentionally omitted <==

BRCA test: Medicare Benefits Schedule:

  - Item 73296 - Fee: $1,200.00 Benefit: 75% = $900.00 85% = $1,115.30[1]
  • Item 73297 - Fee: $400.00 Benefit: 75% = $300.00 85% = $340.00[2]

  • LYNCH Syndrome test: Medicare Benefits Schedule

    • Item 73354 - Fee: $1,200.00 Benefit: 75% = $900.00 85% = $1,115.30[3]
  • 1 http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73296&qt=ItemID

  • 2 http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73297&qt=ItemID

  • 3 http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73354&qt=item&criteria=lynch%20syndrome

==> picture [60 x 32] intentionally omitted <==

Our Divisions

Emerging divisions Existing divisions

==> picture [115 x 111] intentionally omitted <==

----- Start of picture text -----

Germline t esting
BRCA, Lynch
Syndrome and
Somatic testing
----- End of picture text -----

==> picture [159 x 86] intentionally omitted <==

==> picture [114 x 111] intentionally omitted <==

----- Start of picture text -----

Mental Health
by Taliaz
----- End of picture text -----

==> picture [115 x 110] intentionally omitted <==

----- Start of picture text -----

Metabolic
diseases
Diabetes
----- End of picture text -----

NEW – Universal collection test Kit To support Multi Test Launch

==> picture [299 x 231] intentionally omitted <==

BC = Breast Cancer; CRC = Colorectal Cancer; PC = Prostate Cancer; CVD = Cardiovascular Disease; IHD = Ischemic Heart Disease; Atrial Fibrillation

==> picture [60 x 32] intentionally omitted <==

Our Innovation

geneType integrates genetic risk and clinical risk to better stratify individual risk. Patients with potentially high risk may exceed actionable clinical guidelines 10 – 15 years earlier than those with low risk[1,2,3]

Breast Cancer (BC)[1]

Colorectal Cancer (CRC)[2]

==> picture [311 x 168] intentionally omitted <==

Chronic Heart Disease (CHD)[3]

==> picture [229 x 167] intentionally omitted <==

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.

Our Portfolio − Driving Growth

CIT Platform in AUS and USA selling BRC and CRC

IBX COVID Risk Test released for sale May 31, 2021

==> picture [54 x 66] intentionally omitted <==

==> picture [60 x 41] intentionally omitted <==

Moderate Revenue Expectations Q2 CY 2021

Revenue Commenced Q2 CY 2021

100% Germline + PRS test for Breast Cancer and CRC to launch in AU & USA

Expanding into reimbursable space Revenue Expectations Q4 CY 2021 BRCA Lynch Panel Syndrome

Multi Test to provide Risk assessment for >70% of all morbidities to launch

Market Release to include up to 70% of Morbidity :

==> picture [92 x 73] intentionally omitted <==

  • Breast Cancer

  • • Colorectal Cancer Revenue • Cardiovascular Disease Expectations • Type 2 Diabetes • Melanoma Q4 CY 2021 • Prostate Cancer

December 2020

April 2021

July 2021

H2 2021

11

==> picture [60 x 32] intentionally omitted <==

Significant market opportunity

To provide predictive, pre-symptomatic testing to inform lifestyle choices and healthcare discussions

Near Term Addressable Market

281,550[5] Diagnosis of breast cancer annually in United States (19,974 cases diagnosed annually in Australia[3] )

1[st] degree relatives

==> picture [170 x 87] intentionally omitted <==

----- Start of picture text -----

1 [st] degree
relatives
----- End of picture text -----

149,500[6] Diagnosis of colorectal cancer annually in United States (15,494 cases diagnosed annually in Australia[4] )

GTG Target Market for

==> picture [341 x 266] intentionally omitted <==

----- Start of picture text -----

BRCA Panel + Breast Cancer PRS
Testing
providing up to 100% genetic
risk cover screening
GTG Target Market for
LYNCH Syndrome Panel + Colorectal
Cancer PRS Testing
providing up to 100% genetic
risk cover screening
----- End of picture text -----

==> picture [804 x 49] intentionally omitted <==

----- Start of picture text -----

Global Predictive Genetic Testing Market anticipated to exceed $28bn by 2026 [1]
----- End of picture text -----

  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 Analysis 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

Our Innovation - Multi Test

One test 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

==> picture [297 x 313] intentionally omitted <==

GeneType Multi-test to include Oncology >70% of mortality & morbidity Breast Cancer 1 Colorectal Cancer Prostate Cancer Melanoma Pancreatic Cancer Ovarian Cancer Cardiovascular 2 Atrial Fibrillation Coronary Artery Disease Metabolic Type 2 Diabetes 3 Mental Health Taliaz 4 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

==> picture [60 x 32] intentionally omitted <==

EasyDNA – Acquisition of DTC Platform

  • This acquisition provides Genetic Technologies the foundation to grow in 40 countries with an extensive DTC market channel

  • Agreements with 12 laboratories in North America, AsiaPac and Europe

  • EasyDNA currently sells paternity, oncology and health and wellbeing genomics-based tests

  • A platform to launch the geneType Multi Test and portfolio of serious disease tests across the globe

  • Offices in Malta with a subsidiary in Australia, CEO is based in Malta

  • Current revenues of US$4.63 million through retail sales of its at-home DNA tests

==> picture [307 x 135] intentionally omitted <==

Our Capability

Dedicated Innovation Hub

Developing and capturing the next generation of innovation in genomics

==> picture [279 x 270] intentionally omitted <==

----- Start of picture text -----

Genetic based
preventative
healthplatform
----- End of picture text -----

==> picture [140 x 12] intentionally omitted <==

----- Start of picture text -----

Marketing and Positioning
----- End of picture text -----

Enhanced Sales and Distribution

Creating a consumer and patient led infrastructure for a direct to consumer e-commerce and B2B sales platform

Capitalise on Licensing, JV and M&A opportunities Partner with leading commercial labs in regions

==> picture [107 x 10] intentionally omitted <==

----- Start of picture text -----

Commercial Finance
----- End of picture text -----

Education and Advisory

Innovation underpinned by controlled operating expenditure

Leveraging partnerships with institutions Oversight and advise to guide ethics and inform innovation

==> picture [143 x 27] intentionally omitted <==

----- Start of picture text -----

Enhanced IT infrastructure
Futureproofing our platform
----- End of picture text -----

==> picture [94 x 10] intentionally omitted <==

----- Start of picture text -----

Internal Structure
----- End of picture text -----

Resourced to deliver with significant medical and business acumen inhouse to continue to drive value

==> picture [60 x 32] intentionally omitted <==

Our Summary

==> picture [869 x 363] intentionally omitted <==

----- Start of picture text -----

03
01 02 04 05 06
Our Vision and Our Markets Our Channels & Our Portfolio & Our Acquisition Our Capabilities
Values Divisions Innovation
Targeted and Focused and Cutting edge Positioned for Aligned to
deliberate distinct innovation growth execute
----- End of picture text -----

16

==> picture [60 x 32] intentionally omitted <==

Thank you

==> picture [60 x 32] intentionally omitted <==

Appendices

==> picture [297 x 372] intentionally omitted <==

==> picture [60 x 32] intentionally omitted <==

Our Intellectual Property

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

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

  • 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

==> picture [60 x 32] intentionally omitted <==

Board and Management: Sales and Scientific expertise leading GTG

Mr. Peter Rubinstein

BEc, LLB Chairman - Non – Executive Director

==> picture [77 x 79] intentionally omitted <==

Dr. Lindsay Wakefield MBBS Non – Executive Director

==> picture [73 x 78] intentionally omitted <==

Mr Nick Burrows B.Com, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director

Simon Morriss GAICD Chief Executive Officer

==> picture [78 x 78] intentionally omitted <==

Dr. Jerzy “George” Muchnicki MBBS Executive Director & Chief Medical Officer

==> picture [78 x 79] intentionally omitted <==

Erika Spaeth PhD Director of Clinical Affairs & Medical Education

Richard Allman BSc, PhD Chief Scientific Officer

==> picture [76 x 78] intentionally omitted <==

Mike Tonroe BSc, FCA, MAICD Chief Financial Officer

==> picture [77 x 78] intentionally omitted <==

Carl Stubbings Chief Commercial Officer (Joining September 2021)

==> picture [60 x 32] intentionally omitted <==

Strong Scientific Leadership: Advisory Board

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

==> picture [78 x 78] intentionally omitted <==

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

==> picture [70 x 70] intentionally omitted <==

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

==> picture [60 x 32] intentionally omitted <==

Corporate Overview

Top 50 share registry breakdown

==> picture [224 x 221] intentionally omitted <==

----- Start of picture text -----

Other, 21%
Board and
Management ,
7%
BNY Mellon,
72%
----- End of picture text -----

==> picture [60 x 32] intentionally omitted <==

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 multifactorial. 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 multiplicative 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 disease than in people without the disease. Each study can look at hundreds or many thousands of SNPs at the same time. Researchers use data from 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 among people. Each SNP represents a difference in a single DNA building block, called a nucleotide. For example, a SNP may replace the 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 not 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 through a proven network of best practice industry experts for customers who require confidence in the delivery of their products and 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 molecular biology.

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 to the consumer.