Genetic Technologies is a diversified molecular diagnostics company. A global leader in genomics-based tests in health, wellness and serious disease through its geneType and EasyDNA brands. GENE offers cancer predictive testing and assessment tools to help physicians to improve health outcomes for people around the world. The Company has a proprietary risk stratification platform that has been developed over the past decade and integrates clinical and genetic risk to deliver actionable outcomes to physicians and individuals. Leading the world in risk prediction in oncology, cardiovascular and metabolic diseases, Genetic Technologies continues to develop risk assessment products.
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GENE Investor Deck May 2023
1. Genetic Technologies – Investor Webinar
The Future: Unlocking personalised preventative medicine
4 May, 2023
Authorised by the Board of Directors of Genetic Technologies Limited
ASX: GTG
NASDAQ: GENE
2. 2
World leading portfolio
2
Most comprehensive guideline driven
portfolio for human and animal health.
• Patented GeneType Multi Risk Test
• Non-Invasive Prenatal Testing (NIPT)
• Carrier screen testing
• Pharmacogenomics
• Oncogenetic diseases
• Pet care
Revenues anchored by our 3 brands to seize
a multi Billion-dollar opportunity.
3. [insert revenue structure
and agreement types]
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and agreement types]
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and agreement types]
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3
Comprehensive genomics-based testings
via a multi-brand strategy
Direct to Consumer
Testing (DTC)
with no medical supervision
Consumer initiated
testing (CIT)
with medical supervision
Medical & Payer
Business to
Business (B2B)
Oncology – GTG
Cardiovascular
Prenatal NIPT
Carrier testing
Clinical & Molecular
Metabolic
Expanded Carrier testing & NIPT
Oncology – MultiTest
Cardiovascular – MultiTest
Metabolic – MultiTest
COVID Rick Test
Pharmacogenomics
Ancestry
Paternity
Health & Wellbeing
Pharmacogenetics
Animal
Drug testing
Relationship
DNA Storage
5. Snapshot and Achievements last 12 months
5
✓ 9 Tests NOW commercially available in the US
the geneType Multi-Risk test
✓ >100 medical practices on-boarded launching
the foundation of geneType Hubs in Australia
✓ Presentations by Dr Erika Spaeth at:
✓ ASCOGI Cancers Symposium Jan 2023
✓ San Antonio Breast Cancer Symposium,
✓ Precision Medicines leaders summit
✓ Precision Medicine World Conference
✓ Completed 2 Acquisitions
✓ NEW EasyDNA Website ready for launch
✓ NEW eCommerce Platform ready launch
✓ Launch Carrier Testing and Non-Invasive
Prenatal Tests (NIPT) into Europe
✓ Partnering in India with stud farms extending
paternity infrastructure into the equine industry
✓ Launch DNA storage solution in GTG NATA
approved facility
✓ Independently developed Budget Impact
Model (BIM) identifies US$1.4 billion dollars
in annual saving by ALVA 10
✓ 11 Active payer conversations
✓ Progress on US Payer meetings to enable
coverage across millions of lives
✓ Launch with A/Prof Charles Siles providing
immediate access to more than 1,000
referring primary care physicians and 15,000
patients annually in Australia
✓ Partnerships with Australian Breast Care
Centre and Dr Nicole Yap
✓ Launch of screening for breast cancer risk
with Prof Bruce Mann at Royal Women’s
Hospital in Melbourne
✓ 5 Peer reviewed publication in 6 months
✓ Published in PLOS ONE
✓ Published in Journal or Precision Medicine
✓ Published in European Journal of Cancer
prevention
✓ Published in journal Breast Cancer Research
and Treatment
✓ 25 Patents granted or pending
✓ 3 more papers under review
✓ Gained NATA and CMS-CLIA
accreditation and certification for 6
polygenic risk score tests
✓ Successful ARTG notification to TGA for
company IVDs for all tests on the multi-
risk test
GeneType commercialization EasyDNA & Affinity DNA Reimbursement activation
Partnerships Clinical Validity and IP Strategy Laboratory Capability
6. half-year ending December
31, 2021
Delivering Revenue and Growth – Q3 FY23
$1,967
$2,232
$4,626
$6,687
Q3 FY22 Q3 FY23 YTD FY22 YTD FY23
Cash Receipts (A$'000)
Strategic & Operational Highlights:
• March Quarter FY23 receipts A$4.22 million
• Cash receipts from customers A$2.2m +13% on last year;
• R&D Tax Incentive of A$1.96m was received in Q3 2023
• YTD receipts from customers A$6.69 million up 45% on prior year
• 7 consecutive qtrs. of growth on prior year
Q3 CASH RECEIPTS
A$2.2m
GROSS MARGIN
A$1.13m
March GROSS MARGIN
49% +2ppts
6
CASH BALANCE
A$10.5m*
*As at 31 March 2023
# All revenues for the period ‘21 & ‘22 are 'out of pocket' our strategy for reimbursement should become effective in 2023 FY
45%
Growth
on LY
• Launched Melanoma, Pancreatic Cancer and Atrial Fibrillation in U.S.
• Back to Back peer reviewed publications demonstrating Genetype for
Breast cancer identifies MORE at risk patients then the current
standards
• Presentations at ASCO Gi Cancers Symposium in San Francisco
7. Commercialisation of the geneType suite of multi-risk tests
Our FOCUS
Core ‘4’
Commercialisation of the geneType suite of multi-risk tests
Demonstrate clinical validity & clinical utility of geneType tests
Innovation: Next Generation of capability – Starting with Epigenetics
EasyDNA & Affinity DNA Revenue Growth: Tests, Channels. & Markets
Execute the B2B commercialisation of the geneType multi-risk test
7
8. NEW Comprehensive Breast and Ovarian Cancer test
Evaluates a woman’s risk of developing Breast and/or Ovarian Cancer in women 30 years+
• The test evaluates a women’s risk of developing Breast and/or Ovarian Cancer either from a hereditary genetic
mutation or from the far more common familial or sporadic cancer. (Announced Feb 3, 2023)
• GTG’s unique approach “appends” the detection of the 13 major “actionable” Breast and Ovarian cancer
susceptibility genes to the GeneType test platform.
• Advances the goal of providing population-based genetic screening where up to 85% of cancers diagnosed do
not have hereditary or family history
• Showcase at BRCA 2023 in Montreal
1 https://www.breastcancer.org/facts-statistics
Announcement - Globe Newswire
5% - Hereditary Cancer
with known pathogenic
variant BRCA1/2
85% - GeneType Patented
integrated Breast and
Ovarian Risk test
10% - Familial cancer with
no known pathogenic
variant
9. [insert revenue structure and agreement
types]
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NEW – 9 Diseases now available in the US
GeneType can identify patients ’at risk’ before onset and aid in the early detection and treatment.
GeneType Risk assessment test for breast cancer has demonstrated improved early stage detection by
18% and saving approx. US$1.4B per annum4 for the US payer
9
Phase 1 Launch 2
GeneType Multi-
test covers
>70% of mortality
& morbidity
Phase 2 Launched – US March 20233
1. TGA, FDA and EU regulatory approval granted to the sponsor, DNA Genotek
2. Commercial availability in Australia and the US since Q1 CY2022
3. Commercial availability in the US and waiting on NATA Approval for Australia
4. Budget Impact Model prepared by Alva10
Breast Cancer
Colorectal Cancer
Prostate Cancer
Melanoma
Pancreatic Cancer
Ovarian Cancer
Oncology Cardiovascular
Atrial Fibrillation
Coronary Artery
Disease
Metabolic
Type 2 Diabetes
Diseases Areas
One report. Two risk scores.
Actionable results
10. Cancer Prevention Research
Validation of an abridged breast cancer risk prediction model
for the general population1. Spaeth EL, Dite GS, Hopper JL, Allman R.
European Journal of Cancer Prevention
A combined clinical and genetic model for predicting risk of
ovarian cancer2 Dite GS, Spaeth E, Murphy NM, Allman R.
Breast Cancer Research and Treatment
Validation of a breast cancer risk prediction model based on the
key risk factors: family history, mammographic density and
polygenic risk3 Allman R, Mu Y, Dite GS, Spaeth E, Hopper JL, Rosner BA.
NEW – 3 Peer Review Publications Released
Our Scientific team continues to achieve scientific publication milestones, with 3 publications
accepted in three peer-reviewed journals during the quarter
10
1. https://pubmed.ncbi.nlm.nih.gov/36862830/
2. https://pubmed.ncbi.nlm.nih.gov/36503897
3. https://pubmed.ncbi.nlm.nih.gov/36749458/
Guideline driven, Actionable results
3 NEW Peer
reviewed
Publications in
the latest Qtr
11. NEW Strategic Alliance with Qiagen
The alliance will establish and develop a ‘Centre of Excellence’ facility in Australia
QIAGEN will support the enhancement of GTG capabilities
through software, hardware, consumable and technical
solutions, including:
• Reagents and QIAGEN’s proprietary QCII software to
complete Next Generation Sequencing (NGS) validation
in house.
• The rollout will include QIAGEN’s QIAseq targeted DNA
Pro Sample to Insight solutions for NGS Oncology and
customized inhouse data analysis tools to provide
sample to result service for GTG customers
Announcement – Globe Newswire Feb 1 2023
12. [insert revenue
structure and
agreement types]
Product list
Medical & Payer
Business to
Business (B2B)
GeneType Priority Pathway to Market
Health Economic modeling completed by
ALVA10*
Certifying reimbursable testing platform:
BRCA test & LYNCH Syndrome test
A plan curated for: Payers / Insurers*
Primary Care Physicians, Specialists,
Surgeons, Concierge Medicine Groups
geneType Multi-test
NGS platforms with Germline, Carrier
Screening and NIPT
BRCA test & LYNCH Syndrome test
Revenue
Drivers
Partners
Products
* Corporates and Insurance market entry assessment in progress and Health Economic Model being completed by ALVA10. 12
Payer coverage is the key driver of revenues for geneType
Coverage from payers in the US will accelerate adoption of
geneType Risk Assessment Tests more widely
Budget Impact Model (BIM) demonstrates significant health &
economic benefits of implementing the geneType Breast
Cancer Risk Assessment Test
11 Active conversations with payer groups in the US
US Payers include:
• Humana – 17 million lives covered
• Aetna – 22.1 million live covered
• Independence Blue Cross – 3 million lives covered
Smaller payers such as employer groups have potential to
move quickly
BIM validates the benefits of implementing geneType
13. Economic Modeling in the US Payer System1
The economic benefit to the payers in the US is US$1.4B per annum
$73
US Payor system
will save per
patient per year
69% - 74%
overall increase in
women getting
screened
6.8%-9.2%
Supplemental
screening frequency
14.8% - 8.8%
Interval Cancers
drop
57% - 67%
Early-stage cancer
detection
1 Corporates and Insurance market entry assessment - Health Economic Model completed by ALVA10 May 2022.
3.6% in annual savings to a payer system in the screening and treatment of
breast cancer.
13
14. [insert revenue structure and
agreement types]
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[insert revenue structure and
agreement types]
Product list
PHASE 1
Brand Re-Ignition
DTC - Growth strategy for EasyDNA
Brand Refresh
Multi-brand Portfolio
EasyDNA Brand Refresh
Test Rationalization
Website Refresh
Website Development
First-party data collection
Targeted Messaging
Improve User experience and
engagement
PHASE 2
Revenue and Growth Focus
Improved Lead Gen
Google Ads
Facebook Ads
Content & Email Marketing
Influencer Marketing &
Testimonials
New Sales Channels
Amazon store front
Target B2B customer
segments
New Markets
14
18. Dr. Lindsay Wakefield
MBBS
Non – Executive Director
Mr. Peter Rubinstein
BEc, LLB
Chairman
Non – Executive Director
Dr. Jerzy “George”
Muchnicki
MBBS
Non-Executive Director
Mr Nick Burrows
B.Comm, FAICD, FCA,
FGIA, FTIA, F Fin
Non – Executive Director
Simon Morriss
GAICD
Chief Executive Officer
Richard Allman
BSc, PhD
Scientific Advisor
Tony Di Pietro
B. Comm, CA, AGIA, MAICD
CFO & Company Secretary
Carl Stubbings
Chief Commercial
Officer
Erika Spaeth
PhD
Director of Clinical &
Scientific Affairs
Board and Management:
Sales and Scientific expertise leading GTG
18
19. 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
A.Prof Ron Dick
MBBS, FRACP, FCSANZ,
Chairman of Cardiovascular
Institute at Epworth Healthcare,
an Honorary Cardiologist at the
Alfred Hospital and Bendigo
Healthcare Group.
Completed his MBBS in 1979 and
became a Fellow of the
Australian College of Physicians
in 1986. His interventional
cardiology fellowship was from
the University of Michigan
Medical Centre USA.
19
20. • Net cash outflow of A$7.2 million for the nine months to 31 March 2023.
We continue to grow EasyDNA and Affinity DNA brand sales and
develop and commercialise our geneType tests
• Cash reserves will be directed to:
• to support the commercialisation of the GeneType Multi Risk
test through the B2B channels with payers, insurers and
employers in the United States and expand into Europe;
• to drive new market opportunities in reimbursable categories
by leveraging our strategic relationship with QIAGEN;
• for funding product research and development;
• to increase our sales and marketing presences and drive of its
tests via the consumer-initiated testing platforms;
• to execute the go to market, sales and marketing to launch the
Comprehensive Hereditary Breast and Ovarian Cancer Risk
Test as part of our germline genetic testing division; and
• for other working capital and general corporate purposes.
A$’000 31-March-23 31-March-22 Change
Net operating cashflow (7,249) (6,152) -18%
Receipts from customers 6,687 4,626 45%
Cash 10,481 11,350 -8%
1 Based on cashflow projections
20
Financial Overview
21. BNY Mellon, 71%
Board &
Management ,
5%,
Other, 24%
BNY Mellon Board & Management Other
Top 50 share registry breakdown
Financial Information
Share price (AUD) as at 25 April 2023 0.3c
ADR price (USD) as at 25 February 2023 $1.06
Ord Shares on Issue (M) 11,542
ASX 52-week trading (AUD low/high) 0.2/1.3c
Nasdaq 52-week trading (USD low/high) 0.86/1.82
Market Cap (A$M/US$M) 34.6/19.0
Cash at 31 March 2023 A$10.5m
Cash at 30 June 2022 A$11.7m
Debt (30 June 2022 and 31 March 2023) nil
Dual Listed on the ASX and Nasdaq
Corporate Overview
21
22. 4 Patents granted in the US
• Patent No: US 11,257,569, Methods of
assessing risk of developing a severe
response to Coronavirus infection
• Patent No: US 11,072,830, Methods for breast
cancer risk assessment
• Patent No: US 10,683,549, Methods for
assessing risk of developing breast cancer
• Patent No: US 10,920,279, Methods for
assessing risk of developing breast cancer
2 Patents granted in PRC (China & HK)
• Patent No. 201080033130.5 Methods for Breast
Cancer Risk Assessment
• Patent No. 201580063966.2 Methods for
assessing risk of developing breast cancer
9 Patent families pending
• Breast cancer risk assessment
• Methods for assessing risk of developing prostate cancer
• Methods for assessing risk of developing ovarian cancer
• Methods of assessing risk of developing a severe response to
Coronavirus infection
• Methods of assessing risk of developing a disease
• Methods for assessing risk of developing breast cancer
• Improved methods for assessing risk of developing breast
cancer
• Methods of assessing risk of developing breast cancer
• Methods for assessing risk of developing colorectal cancer
Our Intellectual Property
22
* Patents granted are specific to the GeneType portfolio of products
23. 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.
Health Care Professionals (HCP) – physician, GP, or specialist authorized to receive the patient results
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