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GENETIC TECHNOLOGIES LIMITED — Investor Presentation 2021
Mar 8, 2021
65022_rns_2021-03-08_fba98801-12c0-43c1-9d2e-ba6cdcb446e0.pdf
Investor Presentation
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ASX Market Announcement
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GTG presenting at HC Wainwright Conference
Melbourne, Australia, 9 March 2021: Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE, “Company”, “GTG”), a diversified Genomics and AI driven preventative health business advises that Chief Executive Officer, Simon Morriss will be presenting at HC Wainwright’s Global Life Sciences Conference at 9am EST/ 11pm AEDT, Tuesday 9 March 2021.
Additionally, management will be hosting a ‘Meet the CEO’ event for Australian based investors to have the opportunity to hear from Chief Executive Officer, Simon Morriss on the strategy for the Company and the recently announced Infinity BiologiX agreement.
Date: Thursday 11[th] March 2021
Time: 1:00pm AEDT
Registration: https://us02web.zoom.us/webinar/register/WN_6K30zFxQSKug6DAgg6hqQg
Attached is the associated presentation.
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Authorised by the Board of Genetic Technologies
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
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Investor Relations (AUS)
Stephanie Ottens Market Eye M: +61 434 405 400 E: [email protected]
Investor Relations and Media (US)
Dave Gentry 1 800 RED CHIP (733 2447) Cell: 407 491 4498 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
Genetic based preventative health platform
Genetic Technologies Investor Presentation March 2021
Authorised by the Board of Genetic Technologies
Notice: Forward looking statements
The purpose of the presentation is to provide an update of the business of Genetic Technologies Limited 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 Genetic Technologies 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 Genetic Technologies’ 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 Genetic Technologies’ 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 Genetic Technologies. 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.
*Defined terms are outlined in the Appendices to this presentation
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Genetic Technologies Empowering a healthier life!
A diversified genomics and AI driven preventative healthcare company, partnering to provide individualised risk assessment of serious disease.
Genetic Technologies - Leader in Genomics
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Publications and academic
Strong focus on R&D Robust patent portfolio collaborations
Over a decade of R&D on the 15 patents granted and 7 patent Multiple peer-reviewed publications and
development of polygenic risk scores families pending four collaborations with prestigious
academic and medical establishments
Multi-year
70%
distribution agreement
$24 million Up to 70%
US License and distribution agreement for Strong cash balance with 18-24 Coverage for all mortalities from tests in
COVID-19 Risk Test with IBX for minimum of month runway [1] development for serious disease risk
US$2.9 million over 3 years including major oncological, metabolic
and degenerative diseases
Launched CIT in USA & Aus for other tests
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We aim to offer the most comprehensive suite of genetic risk assessment tests on the market
- Pro forma cash position following capital raise on 25 January 2021
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Product overview – innovation Pipeline
Released 2019/2020
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Colorectal Cancer Breast Cancer
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TGA Approved
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Depression
(PREDICTIX by Taliaz) Type 2 Diabetes
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Distribution partnership confirmed
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COVID-19
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PRS Products Under Development
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Melanoma
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Prostate Cancer
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Germline Products Under Development
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BRCA Panel Lynch Syndrome
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Cardiovascular Multitest
Disease
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Overview of product timeline
Remain on track to deliver products
1H1HCY21CY20
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COVID-19 SDR Test
Increased data set is currently undergoing integration into our risk test. Product completion expected to be end of Q1 CY21
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Germline Testing BRCA/Lynch Syndrome
In December 2020 created an aligned reimbursable strategy with Breast Cancer and Colorectal Cancer PRS tests
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Mental Health
PREDICTIX by Taliaz
Introduced in December 2020 and marks the first foray into Pharmacogenomics and first product established through license and distribution arrangement
2H CY21 and beyond
High Density/Multitest
Following the completion of the 1H CY21 tests GTG will progress with the completion of the Multitest products with the intention of releasing a High Density/Multitest following the completion of the included tests.
Market Release to include the following:
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Breast Cancer
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Colorectal Cancer
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Cardiovascular Disease
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Type 2 Diabetes
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Melanoma
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Prostate Cancer
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COVID-19
Covering more than 70% of all mortalities
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Responding to unique opportunities and challenges
Genetype for COVID-19 SDR Test - World first serious disease risk (sdr) test that predicts your risk of hospitalisation & life threatening complications
Highlights
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Rapid response and creation of the test
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Expected to be market ready Q1 CY21[1]
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Allows individual to know their risk of series consequences from contracting COVID-19
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Currently undergoing technical certification[2]
Product Overview
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Simple oral swab test
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Allows for remote screening
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Accurate and low cost[3]
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Designed to identify who:
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may be at risk of serious life-threatening complications
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should isolate as a precaution
Distribution and license Agreement with Infinity BiologiX
- **Initial three-year co-exclusive license agreement for**
- **sale and distribution of GTG’s COVID-19 Risk Test in the US**
- **Minimum payments US$2.9 million over three years**
- **IBX currently has the capacity to process over 100,000 COVID-19 Risk Tests per day across its two major labs**
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should be prioritised for vaccination • GTG to receive US$10 per test with no additional COGs
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Combines genetic risk with clinical risk
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Could provide the ability to prioritise medical intervention for high-risk individuals
- Also can leverage an existing network of SARS-CoV-2 testing partners and associated medical practitioners across the US
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Over 100% better at identifying risk than age and gender alone[3]
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Increased data set is currently undergoing integration into our risk test. Product launch expected to be end of Q1 CY21
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GTG anticipates the registration of an LDT COVID-19 severity test should take less than 45 days after completion of validation and technical certification (based on estimates received) 3. “An integrated clinical and genetic model for predicting risk of severe COVID-19” available at: https://www.medrxiv.org/content/10.1101/2020.09.30.20204453v1.full.pdf
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Significant market opportunity
GTG aims to provide up to 100% predictive, pre-symptomatic testing - Germline (5%-10%) and Non Familial (90%) Key insights to inform lifestyle choices and healthcare discussions
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Near Term Addressable Market GTG Target Market for
BRCA Panel + Breast Cancer PRS Testing
275,000 providing up to 100% genetic
1 [st] degree risk cover screening
Diagnosis of breast cancer
annually in United States relatives
(19,974 cases diagnosed annually in Australia)
GTG Target Market for
LYNCH Syndrome Panel + Colorectal
148,000
1 [st] degree
Diagnosis of colorectal cancer Cancer PRS Testing
annually in United States relatives providing up to 100% genetic
(15,494 cases diagnosed annually in Australia) risk cover screening
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Global Predictive Genetic Testing Market anticipated to exceed $28bn by 2026[1]
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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
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PRS = Polygenic Risk Score
Partnership to provide expanded product offering
Genetype for Depression - Powered by Taliaz’s PREDICTIX platform
Highlights
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Key opportunity with strong product alignment to integrate into our platform in line with our mandate to expand our product offering
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Provides entry into mental health and pharmacogenomics segments
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Regulatory status:
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CE Marked
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TGA approved, expected to be market ready by the end of 1H CY21
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Anticipated for market release in 2H CY21
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Distribution Agreement
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Minimum distribution of 8,000 tests over the initial
- three-year term
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Pricing not yet determined but expected to be in line with current test pricing of ~A$350 per test
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Product Overview
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Utilising a combination of:
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Genetic, metabolic, clinical and demographic background data; in conjunction with
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Artificial Intelligence and Machine Learning
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Creates diagnostic and pharmacogenetic solutions that are
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47% better than current best in class practices.
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Better individual outcomes due to superior
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therapeutic drug selection
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1 in 8 47% 1 in 10
Australian prescribed antidepressants Improvement on accuracy of prescribing Americans prescribed antidepressants
annually [1] antidepressant [2] annually [3]
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Source: Psychwatchaustralia
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Based on a retrospective analysis of STARD study medications versus current clinician treatment selection prescribing accuracy (Chekroud et al., 2016). STARD is one of the world’s largest prospective studies for optimal antidepressant administration.
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Source: https://www.health.harvard.edu/blog/astounding-increase-in-antidepressant-use-by-americans-201110203624
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Strategy
GTG have established a clear product pipeline and direction:
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Transitioned from one product two years ago to 10 products in development
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Ability to accelerate the development of new products and tests
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Expanding into reimbursable space
Focused on:
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Establishing leadership through peer reviewed publications, providing reimbursable products and leveraging key opinion leaders
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Forming relationships with large US based labs to provide a clear avenue for increased scale and product distribution through licensing agreements
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Providing individuals with management and lifestyle insights that can be implemented 15-20 years before onset of disease to extend quality of life through:
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Products that are designed to improve medical and lifestyle outcomes - mediated through environmental changes, supplements and medications where appropriate
Controlled operational costs
- Only ~10% increase associated with expanded product base to date
Continually evaluating further opportunities
- Continue to focus on research and development alongside product innovation
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Genetic based
preventative
health platform
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- Leveraging in market products to enhance product offering (ie. Taliaz)
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Expanding divisions and product offerings
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ONCOLOGY Lifestyle
Ancestry
BC, CRC, PC, /Microbiome
Melanoma
GENETIC
TECHNOLOGIES
CVD Pharmoco-
(Heart Disease) genetics
IHD, AF
Mental
Metabolic
Health
Diseases (by Taliaz)
Diabetes
COVID-19 Germline
serious Testing
disease risk (BRCA, Lynch
(sdr) Syndrome)
Emerging divisions
Existing divisions
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Medical/Pharmacogenetics pathway
Third Party Licensing
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Provides enhanced distribution and product offering via:
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Licensing of own products for enhanced distribution opportunities (ie. Infinity BiologiX COVID-19 Risk Test)
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Licensing of novel products for enhanced product offering (ie. PREDICTIX by Taliaz)
Business to business sales via the medical profession
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Adversely impacted by COVID-19 restrictions but remains a key avenue for education and sales
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Combined with an educational program to target mediated healthcare professional industry education content providers
Certifying reimbursible Germline testing platform anticipated to be completed by end of 1H CY2021
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BRCA test: Medicare Benefits Schedule:
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Item 73296 - Fee: $1,200.00 Benefit: 75% = $900.00 85% = $1,115.30[1]
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Item 73297 - Fee: $400.00 Benefit: 75% = $300.00 85% = $340.00[2]
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LYNCH Syndrome test: Medicare Benefits Schedule
- Item 73354 - Fee: $1,200.00 Benefit: 75% = $900.00 85% = $1,115.30[3]
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http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73296&qt=ItemID
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http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73297&qt=ItemID
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http://www9.health.gov.au/mbs/fullDisplay.cfm?type=item&q=73354&qt=item&criteria=lynch%20syndrome
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Pathways to market
Consumer initiated testing (CIT) with medical supervision
Medical – Business to Business (B2B)
Third Party Certifying Launched US and Current products Licensing reimbursable Australia CIT include: Germline testing platforms in 2020 Business to platform with medical GeneType for business sales via supervision with: Breast Cancer the medical BRCA test profession InTeleLabs in the GeneType for LYNCH Syndrome US Colorectal Cancer test Phenix Health in priced at AUD$349 (More to follow) Australia per test
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Direct to consumer testing (DTC) with no medical supervision
Will be leveraged Scheduled for for ancestry and development gut microbiome following the testing establishment of the regulated disease and reimbursable segments
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Regional Distribution
United States
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Certification required by US regulators CLIA to sell into the USA
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One product[1] currently certified with further products expected to be submitted in next 12 months
Australia
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Certification required by Australian regulators NATA , to sell into the Australian market
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Two products[2] currently certified and further products expected to be submitted in next 12 months
Europe
- Looking to commence CE certification with the view of entering the European market with our novel genetic risk tests in CY2021
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Colorectal launching March 2021
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GeneType for Breast Cancer certified for sale via online sales platform
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GeneType for Breast Cancer and Colorectal Cancer certified for sale via online sales platform
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Genetic Technologies Empowering a healthier life!
Thank You
Appendices
Corporate Overview
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Top 50 share registry breakdown
Dual Listed on the ASX and Nasdaq
21% Financial Information
Share price (AUD) as at 5 March 2021 0.9c
Bank of Melon (Custodian for US ADRs)
ADR price (USD) as at 4 March 2021 $4.16
7% Board and Management Ord Share on Issue (M) [1] 9,012
ASX 52-week trading (low/high) 0.3/1.4c
Other Nasdaq 52-week trading (low/high) $1.41/10.30
72% Market Cap (A$M/$USM) 85.63/62.50
Cash (31 December 2020) $16.4m
Debt (31 December 2020) nil
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- American Depository Receipts (ADRs) are interchangeable via custodian Bank of Mellon with 70%of stock held in the USA
2.600 shares on the ASX equate to 1 ADR (American Depository Receipts) in the USA which are interchangeable via custodian Bank of Mellon
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Financial Overview
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Strong proforma cash position of A$24 million to provide runway for commercialisation and further product development
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Cash burn of $1.48 million a decrease on prior quarter (Q1 FY21: $1.88 million) as a result of a reduction in administrative costs despite increased products in development and focus on product distribution and marketing
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Strong interest from US based institutional investors as evidenced by completion of post quarter end US$6.56 million capital raise on the 25th January used to:
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Support the introduction and distribution of its new products in the United States and Europe
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Reimbursement studies for the polygenic risk tests;
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Implementation of its consumer-initiated testing platforms;
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Preparation for its COVID-19 PRS Test;
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Introduction of germline testing division;
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General product research and development; and
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For general working capital and potential acquisitions.
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$A ‘000s 30 Sept 2020 31 Dec 2020 Change
Net operating cashflow (1,875) (1,481) (21%)
Payments for
438 358 (18%)
Research and Development
Cash 18,095 16,435 (9%)
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Our board and management
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Mr. Peter Rubinstein BSc, BEc, LLB Chairman - Non – Executive Director
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Mr Nick Burrows B.Com, FAICD, FCA, FGIA, FTIA, F Fin Non – Executive Director
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Simon Morriss GAICD Chief Executive Officer
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Dr. Lindsay Wakefield MBBS Non – Executive Director
Dr. Jerzy “George” Muchnicki MBBS Executive Director & Chief Medical Officer
Richard Allman BSc, PhD, Microbiology Chief Scientific Officer
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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 (PRS) - A polygenic risk score tells you how a person's risk compares to others with a different genetic constitution. However, polygenic scores do not provide a baseline or timeframe for the progression of a disease. For example, consider two people with high polygenic risk scores for having coronary heart disease.
- 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.
Genome Wide Association Studies (GWAS) - an approach used in genetics research to associate specific genetic variations with particular diseases. The method involves scanning the genomes from many different people and looking for genetic markers that can be used to predict the presence of a disease. Once such genetic markers are identified, they can be used to understand how genes contribute to the disease and develop better prevention and treatment strategies.
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