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GENETIC TECHNOLOGIES LIMITED Investor Presentation 2011

Jan 9, 2011

65022_rns_2011-01-09_77ee934f-dba6-4d03-ba0d-891d1f96a236.pdf

Investor Presentation

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ASX ANNOUNCEMENT

January 10[th] , 2011


US investor presentation

Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) is pleased to release the attached investor presentation that will be presented by its Chief Executive Officer, Dr. Paul MacLeman, to a number of brokers and fund managers attending the J.P. Morgan Annual Healthcare Conference in San Francisco, California over the coming days.

About Genetic Technologies Limited

Genetic Technologies was an early pioneer in recognising important new applications for “noncoding” DNA (Deoxyribonucleic Acid). The Company has since been granted patents in 24 countries around the world, securing intellectual property rights for particular uses of non-coding DNA in genetic analysis and gene mapping across all genes in all species. Its three-pronged business strategy includes: 1) the global commercialisation of its patents through an active licensing program; 2) the expansion of its dominant commercial genetic testing business with a focus on oncology and cancer management; and, 3) the commercialisation of its various research and development projects aimed at generating further intellectual property of potentially global commercial significance. For more information, please visit www.gtglabs.com.

FOR FURTHER INFORMATION PLEASE CONTACT

Dr. Paul D.R. MacLeman Chief Executive Officer Genetic Technologies Limited Phone: +61 3 8412 7000

Genetic Technologies LimitedWebsite : www.gtglabs.com • Email : [email protected] ABN 17 009 212 328 Registered Office • 60-66 Hanover Street Fitzroy Victoria 3065 Australia • Postal Address P.O. Box 115 Fitzroy Victoria 3065 Australia Phone +61 3 8412 7000 • Fax +61 3 8412 7040

GENETIC TECHNOLOGIES LIMITED (NASDAQ: GENE, ASX:GTG)

January 2011

Forward Looking Statements

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

Genetic Technologies Ltd (NASDAQ:GENE, ASX:GTG)

  • Substantial near‐term global growth opportunities in cancer diagnostics

  • Existing annuities & growing revenues from non‐coding DNA IP out‐licensing

  • Increasing substantially through US IP assertion suit

  • Successes in Europe also

  • 9 Licenses granted 2010

  • 20 year old Aust/NZ molecular diagnostics and genetics business, with historically low share price

  • Expanding global business through acquisition,

Investment Snapshot

  • GTG to soon launch world’s first validated test for non‐ familial breast cancer globally:

  • BREVAGen™ has attractive CoGS and rapid payback

  • Purchased all key assets from Perlegen Inc. incl. BREVAGen™ for less than $1.5m during financial crisis, Perlegen total investment – $328m

  • Target market is global, characterized & large

  • US launch planned first quarter 2011

  • GTG has an established genetics business with infrastructure and reliable, largely contracted operational revenues

  • Existing annuities & growing revenues from non‐coding DNA IP out‐licensing

BREVAGen™ – Launch This Quarter

Novel, validated non‐familial breast cancer risk test:

  • Preparing for US launch Q1 2011

  • Oct10 JNCI validation study

  • High profile KOLs engaged

  • Large validation populations

  • Substantial global opportunity

BREVAGen™ – What it Means Clinically

  • Genetic breast cancer prognostic test

  • Test combines population risk factors (Gail Score) with genetic risk factors (7 SNP biomarkers) to give integrated individual breast cancer risk assessment

  • BREVAGen™ is first fully peer reviewed validated test of its kind

  • BREVAGen™ test informs personalized clinical decision support for non‐familial risk of breast cancer, allowing better

– BREVAGen™ Fits Into Existing ASCO and ACS Breast Cancer Guidelines

Gail Score

1.6m breast biopsy patients pa (USA)

Published Validation Paper

  • Published, Journal of the National Cancer Institute Oct 2010

  • First SNP panel prognostic test to secure a pivotal paper in a top tier journal

Combining validated common genetic risk factors with clinical risk factors resulted in modest improvement in classification of breast cancer risks in white non‐ Hispanic postmenopausal women. Classification performance was further improved by focusing on women at intermediate risk.”

  • “Study demonstrates that the combined

Qualified Market Opportunity

  • US market for existing breast cancer molecular diagnostics ~$690m[* ] in 2006 & grown ~18% CAGR since

  • Referenced by

  • BRACAnalysis (Myriad Inc) sales ~$260m

  • OncotypeDx (Genomics Health) ~$160m

  • Other players (Genzyme[◊] , Clarient[◊] , etc) made up the balance

  • BREVAGen™ US market target is 1m patients pa (65% of 1.6m breast biopsy patients)

  • Ref: U.S. Markets for Breast Disease Detection and Diagnostic Technologies March 2006, Report #A404.

BREVAGen™ SNP Panel

Large Discovery & Validation Data Sets

SNP Discovery

Stage 1: Genotyped 266,722 SNPs in 440 “High‐Risk” Breast Cancer Cases and 400 Controls

Stage 2: Genotyped top 12,711 SNPs in 3990 Invasive Breast Cancer Cases and 3916 Controls

Stage 3: Top 30 SNPs tested in 22,635 Cases (incl. 967 carcinoma in situ) and 20,973 Controls

• 6 SNPs with association <10[‐7]

• 5 novel breast cancer risk loci

Prospective Independent Validation

Cohort/
Sponsor
# Pts SNPs Studied Association
WHI/
Perlegen
3,328 FGFR2, TNRC9, MAP3K1,
LSP1, 8q24, FGF10
BCa risk
Icelandic/
deCODE
13,163 FGFR2 BCa risk
Icelandic/
deCODE
39,161 TNRC9 BCa risk
POSH/
U Southampton
899 FGFR2, TNRC9, MAP3K1,
LSP, 8q24
ER+ BCa risk and
prognosis
SBCS/ Shanghai 3,027 FGFR2, TNRC9 BCa risk;
Asian
Cambridge 2498 FGFR2 BCa risk; African-
American

To Date: 20+ published studies in over 50,000 women

DISCOVERY: Easton DF et al.; Genome‐wide association study identifies novel breast

Compelling Pharmacoeconomics

Presented as a poster ASCO 2010 (Chicago), Archimedes Group + GTG

Intervention Woman’s Age Cost per Life Year Cost per Quality
Adjusted Life Year
BREVAGenTM
vs. Gail Alone*
40‐49 $14,300 $3,900**
BREVAGenTM
vs. Gail Alone*
50‐59 $17,600 $3,800
BREVAGenTM
vs. Gail Alone*
60‐69 $72,100 $7,500
Standard of Care
Annual Mammography only
vs. no screening
40‐79 $42,553
Annual Mammography & CBE vs.
no screening
40‐79 $56,561

Genetics of Breast Cancer Risk

  • Genes can either be detected as

  • Mutations (BRCA1 & BRCA2) or

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Single nucleotide polymorphisms, indicating a higher
with cancer risk
Non‐familial
� 80%
To date; BRCA testing has Hereditary
5%
been well utilized yet
BRCA 1
12%
the vast majority of
breast cancer occurs without an BRCA 2
7%
Familial
indication of family history history
15%
� GWAS have identified novel SNPs which Unknown
81%
are related to non‐familial risk
12
CP1336569‐12
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Target Patient Groups

� Three target markets have been identified:

1. BRCA negative patients

  • 80‐90% of BRCA results are negative

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

ADH/
ALH/
LCIS
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2. Breast Biopsy patients

  • Patients undergoing are known to have increased breast cancer risk

3. Women over 35 who have a family history of cancer

  • One or more relatives but not classified as ‘high risk’

Stages of Sales Channel Growth

  • Initial target market Year 1‐3

  • MD’s with high numbers of BRCA patient tests

  • 80‐90% of BRCA results are negative

  • 1,521 High Value MD/OBGYN’s identified

  • Second target market Year 2‐4

  • MD’s in Breast Biopsy procedures

  • 1m indeterminate biopsy patients per annum

  • 82,000 relevant MD population

Sales and Marketing Deployment

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Sales
Sales
Training
Training Class II
RM Offers Class I
Extended
Q4 ‘10 Q1 ‘11 Q2 ‘11 Q3 ‘11 Q4 ‘11
Oct Nov Dec Jan FebFeb MarMar AprApr MayMay JunJun JulJul AugAug SepSep OctOct NovNov DecDec
Date
Month # -3 -2 -1 0 1 1 2 2 3 3 4 4 55 6 6 7 7 8 8 9 9 1010 11
Marketing
Director Region 1 ManagersRegion7 Region4 ReimbursementDirector, DirectorField
Manager Managers
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Business Overview – Licensing

  • Non‐coding DNA patent estate is one of GTG’s core assets

  • $60m+ licensing revenue received to date

  • Ongoing annuity stream of $9.2m to end of ‘762 patent in 2015

  • Foundational patent families protecting the use of non‐coding DNA

  • � 179, “Intron Sequence Analysis”*

  • ‘762, “Genomic Mapping”

  • ‘063, “Methods For Genetic Analysis”

  • ‘589, “Methods of Genomic Analysis”

Acquired 2010, extant to 2022

  • ‘205, “Genetic Analysis Systems and Methods”

  • Assertion strategy US

  • Single party negotiations EU & RoW

Licensees

50+ licensees across range of industries

‐ Many have delivered synergistic business opportunities

Agriculture Medical Instruments Research

Patent Assertion Program

Parties joined suit #1:

� Partnership with Sheridan Ross PC, a full service intellectual property law firm based in Colorado

� IP assertion program activated & first suit filed in US District Court, Western District of Wisconsin Feb 2010

  • 9 assertion targets selected for first assertion phase

  • � 6 year ‘claim‐back’ in US after patent expiry

  • Off balance sheet financing

  • Delivering results ( see table at R ); 6 settlements to date, more outside of this in Europe and non‐ assertion US

� Beckman Coulter

� Gen‐Probe

  • Interleukin Genetics

� Molecular Pathology Laboratory Network

� Monsanto

  • �Pioneer Hi‐Bred

  • Orchid Cellmark

�PIC USA

  • Sunrise Medical

  • Laboratories

Regulatory & Reimbursement

  • CLIA dossiers submitted – first Australian facilities to service US market

  • Test validation complete with new substrate platform

  • Premier Source (San Mateo, CA) engaged to provide payer management services & reimbursement strategy support : commencing with stacked procedural codes

  • Regulatory & clinical strategy to move to file 5.10(k) &/or comply with anticipated upgraded CMS

Prominent KOLs Involved

Kevin S Hughes, M.D., FACS

Surgical Director, Breast Screening Co‐Director, Avon Comprehensive Breast Evaluation Center Massachusetts

Allison W. Kurian, M.D., M.Sc.

Assistant Professor of Medicine (Oncology) Stanford University School of Medicine

Richard Frieder, MD

Associate Clinical Professor

Department of Obstetrics and Gynecology David Geffen School of Medicine at UCLA

Scott Hayworth, MD

President

Mount Kisco Medical Group

Melanie Bone, MD

550 South Quadrille Blvd Ste 201 West Palm Beach, FL 33401

Jonathan Herman, MD

2500 Marcus Ave Ste 105 New Hyde Park, NY 11042

Frederica Lofquist, MD

3838 California Street Ste 316 San Francisco, CA 94118

Elliott Cazes, MD

14424 Bruce B Downs Boulevard Tampa, FL 33613

� Key Opinion Leaders (KOLs) crucial to

success

� High profile Clinical Advisory Board (CAB) members are assembled to support

product sales

� Key CAB board members and KOLs are being retained

90 S Bedford Rd Mount Kisco, NY 10549

Infrastructure

Genetic Technologies Ltd Fitzroy VIC Australia

Technical & corporate support , and globally accredited efficient sample processing. CLIA Cert pending.

Phenogen Sciences Inc Charlotte NC USA

Competitors

� DeCode (Iceland)

  • Launched in October 2008 by deCODE Genetics, no validation

  • deCODE Breast Cancer test assesses a woman’s risk based on 7 common SNPs, ordered only via MDs. Price = $1,650

  • Emerged from Chapter 11 in April 2010 as a private company (Saga Investments)

  • InterGenetics (Oklahoma City)

  • Breast cancer test is based on 22 SNPs, no validation

  • Limited sales and marketing presence

  • Self generated regulatory difficulties

In contrast, all the SNPs in the BREVAGen panel have Other, largely DTC -7

Oncology Focus

  • New technologies driving targeted interventions & extending lives

  • Molecular diagnosis of cancer is most attractive segment of the Dx industry

  • Focused market & efficient sales process

  • Strong accelerating growth forecast next 4 years

  • Historical PacRim focus

  • US & EU market exposure via BREVAGen™ and follow‐on

Cancer Management Strategy

2005 launch Nov ’09 launch Planned Q1 2011 launch Feb ’10 launch May ’10 launch

Pacific Rim Business

  • Contracted provider to NSW Police Force for volume crime forensic testing

  • 50+% market share Aust/NZ paternity testing

  • Exclusive provider genetic testing most PacRim canine breed clubs

Underwrites revenues in the short to medium term

  • Leading contracted provider of paternity tests to lawyers, Dept of Immigration, Legal Aid

Financial Trends (by quarter)

� Rising revenues

  • Better cost control

  • Trend to positive cash flows

Financial Snapshot Dec 2010

Financials (year to Dec31) Share Register (AUD millions) 2010 2009Shares outstanding 404.6m Operations revenue 5.23 5.38 Top 20 shareholders 76% Licensing revenue 13.62 6.01 Total shareholders 2,850 Net income / (loss) (2.32) (7.85)Options outstanding (*) 14.3m EPS (USD per ADR) (0.17) (0.56) () Employee options only Cash 8.40 5.56Market cap (31[st] Dec)* USD13.9m

Summary

  • GTG to soon launch first validated test for non‐familial breast cancer globally

  • BREVAGen™ has attractive CoGS, ROI & rapid payback

  • Target market is global, characterized and large

  • Launch in US first quarter 2011

  • GTG has a sound established business with reliable, growing operational & licensing revenue streams

  • GTG is publicly traded & driving growth to profitability

  • With current low share price, new investors in GTG gain

Contact Details

Dr Paul D R MacLeman CEO Genetic Technologies Limited Direct Phone +61 3 8412 7025 Cell +61 419 401 445 (Aust.) (980) 253 4340 (US) Email [email protected]