Genetic Technologies Limited · ASX:GTG
Genetic Technologies — J.P. Morgan Annual Healthcare Conference 2014
32 slides from Genetic Technologies's conference presentation, Jan 8, 2014
Slide 1: ASX Announcement: US investor presentation
ASX ANNOUNCEMENT 8 January 2014 US investor presentation Genetic Technologies Limited (ASX: GTG; NASDAQ: GENE) is pleased to release the attached investor presentation that will be presented by its Acting Chief Executive Officer, Tom Howitt, to brokers and fund managers attending the J.P. Morgan Ann
Slide 2: Corporate Overview January 2014
Corporate Overview January 2014
Slide 3: Forward Looking Statements
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
Slide 4: Corporate Overview
Corporate Overview Revenue-generating global diagnostics business focused on women’s health Lead product is breast cancer risk test BREVAGenTM for non-familial (sporadic) breast cancer - Launched mid-2011 and now approved and available in all 50 U.S. states - U.S. CLIA approved and CE Mark awarded H
Slide 5: Phenogen Sciences Inc.
Phenogen Sciences Inc. Established in 2010 to serve as platform for U.S. expansion within women’s health - Headquartered in Charlotte, North Carolina - Manages U.S. sales and marketing of BREVAGen BREVAGen acquired from Perlegen Sciences Inc. in 2010 as a blood-based test - Test adapted by Phenogen
Slide 6: Established Infrastructure
Established Infrastructure Sales and marketing, customer support, reimbursement management and sample accessioning to Laboratory Information Management System in Australia Genetic Technologies Limited Melbourne, Victoria, Australia Technical and corporate support with laboratory globally certified t
Slide 7: Sales Mix by Business Unit
Sales Mix by Business Unit U.S. Operations - BREVAGenTM revenue • Historically accounted for on a cash basis – to move to accruals basis in respect of FY 2014 • Claims received from private insurers • Patient Protection Program provides agreed lower limit for revenue per test Australian Operations -
Slide 8: BREVAGen
BREVAGenTM 7
Slide 9: What is BREVAGen?
What is BREVAGenTM? 8 BREVAGen is a simple swab-based test that can help determine a woman’s risk of developing breast cancer Genetic risk is combined with clinical risk from the Breast Cancer Risk Assessment Tool (BCRAT) to provide an integrated risk score Molecular panel of 7 SNPs (single nucleoti
Slide 10: Scientific Support for BREVAGen
Scientific Support for BREVAGenTM 9 Mealiffe ME, et al. (2010). J Natl Cancer Inst. 102(21): 1618-1627 Assessment of clinical validity of a breast cancer risk model combining genetic and clinical information Confirms the validity of combining SNP genotypes with the Gail model and demonstrates the ut
Slide 11: Breast Cancer Risk: Early Detection Is Key
Breast Cancer Risk: Early Detection Is Key 1 U.S. woman in 8 will develop breast cancer in her lifetime 39,500 of these women will die each year HOWEVER, with early detection, >95% of these women can survive * 10 * http://www.cancer.org/cancer/breastcancer/detailedguide/breast-cancer-key-statistics
Slide 12: BREVAGen Differentiated Integrated Risk Score
BREVAGenTM Differentiated Integrated Risk Score BREVAGenTM provides both a five-year and lifetime percentage risk of developing sporadic breast cancer Allows physicians to recommend a personalized ‘Breast Health Plan’ outlining better surveillance strategies and proactive changes, tailored to each p
Slide 13: BCRAT / Traditional GAIL Score
BCRAT / Traditional GAIL Score Traditionally, a patient’s risk of sporadic breast cancer has been identified by using clinical factors alone Historically known as the GAIL score, Breast Cancer Risk Assessment Tool (BCRAT) measures a woman’s hormonal and reproductive risk factors, including: - Pregna
Slide 14: Cumulative Impact of Common, Low Risk Alleles
Cumulative Impact of Common, Low Risk Alleles Low-risk alleles are predictive of estrogen receptor positive (ER+) tumor types and account for the majority breast cancer incidence More than 80% of breast cancer incidence is sporadic 75% of sporadic breast cancer is ER+ 14
Slide 15: BREVAGen's Clinical Difference
BREVAGenTM’s Clinical Difference Early detection of breast cancer is the key to successfully fighting it - BREVAGen enables more accurate selection of patients for MRI screening - Only 53% of women maintain regular mammographic screening * - BREVAGenTM helps solve the over/under use of the mammograp
Slide 16: Summary - The Benefits of BREVAGen
Summary - The Benefits of BREVAGen™ 16 1. Improved Health Outcomes 2. Improved Cost Effectiveness when intervention and surveillance are appropriately applied to women at higher risk
Slide 17: BREVAGen Competitive Landscape
BREVAGenTM Competitive Landscape There is limited, if any, real competition to BREVAGen, which includes: deCODE (Iceland) - Launched in October 2008 by deCODE Genetics, but with no validation - deCODE Breast Cancer test assesses risk based on 16 common SNPs, ordered only via MDs - Emerged from Chapt
Slide 18: U.S. Market - Targeted Patient Profiles
U.S. Market - Targeted Patient Profiles for BREVAGenTM 18 Women meeting the criteria below may be appropriate candidates for BREVAGen: - Age>35 years - Caucasian (based on current test) - Gail-model appropriate - Other clinical risk factors BREVAGen is appropriate for women who return a negative bre
Slide 19: BREVAGen Performance
BREVAGenTM Performance 78 84 113 142 178 368 403 599 914 1125 0 200 400 600 800 1000 1200 2011/2012 - Q1 2011/2012 - Q2 2011/2012 - Q3 2011/2012 - Q4 2012/2013 - Q1 2012/2013 - Q2 2012/2013 - Q3 2012/2013 - Q4 2013/2014 - Q1 2013/2014 - Q2 BREVAGen Samples Received By quarter (launch to end of Decem
Slide 20: The BREVAGen Ambassadors Program
The BREVAGenTM Ambassadors Program 20 Program now expanded to 23 Key Opinion Leaders (KOLs) with the objective to: - Highlight the utility and value of BREVAGen in the clinical setting - Provide templates for clinic adoption, patient selection and logistics - Drive increased adoption of the BREVAGen
Slide 21: BREVAGen Market Progress
BREVAGenTM Market Progress BREVAGen now available in all 50 U.S. states - Sales force expansion: • Current number of sales reps: 15 • Plan to add a further 3 sales reps in the first half of calendar 2014 (one in New York City, one in Colorado/Utah and one in Minnesota/Nebraska) • Plan to add a furth
Slide 22: Current Locations of U.S. Sales Force
Current Locations of U.S. Sales Force 22 Western Region (7 reps) Seattle Dallas Houston Chicago Southern California Missouri/Kansas Northern California / Nevada Eastern Region (8 reps) New England Northeast Ohio / Michigan DC / MD / VA Florida New Jersey New York City KY / TN / IN
Slide 23: Sample Number Projections to June 30, 2015
Sample Number Projections to June 30, 2015 23 0 1000 2000 3000 4000 5000 6000 7000 8000 Qtr 2 2013 Qtr 3 2013 Qtr 4 2013 Qtr 1 2014 Qtr 2 2014 Qtr 3 2014 Qtr 4 2014 Qtr1 2015 Qtr 2 2015 BREVAGenTM Sample Number Projections Actual Forecast
Slide 24: Reimbursement Profile
Reimbursement Profile In January 2013, there were material changes to the reimbursement process: - Coding changes impacted all genetic / MDx testing in the U.S. - Transition from “code stack” to “miscellaneous” CPT code - Denials and follow-on appeals have since increased, but with strong PPO contra
Slide 25: Reimbursement Improvement – Actions Being Taken
Additional studies to include: • Hispanic American • African American • Expanded SNP panel Clinical Utility Studies to drive MRI and/or Tamoxifen therapy Improved BREVAGen Reimbursement Contract directly with large Self-Insured Employer Groups Contract directly with Insurers Contracting with PPOs In
Slide 26: BREVAGen Product Development
BREVAGenTM Product Development BREVAGen 1.0: 7-SNP assay, available to caucasians only Caucasian population in the U.S. is 62% Recent advances in genetics need to be included Plan to develop and launch BREVAGen 2.0 by third quarter of calendar 2014 Expanded panel for caucasian women Risk assessment
Slide 27: Corporate Summary
Corporate Summary 27
Slide 28: Management
Management Alison J. Mew, Chief Executive Officer (currently on Personal Leave) - Appointed CEO in December 2012 - Background in operations management in the biopharmaceutical industry in Australia and overseas, covering animal and human health - Over 13 years with CSL Ltd. in senior positions Thoma
Slide 29: Licensing Overview
Licensing Overview Seven new licenses granted during the 2013 financial year, totalling 77 to date More than $73 million in gross revenues generated from licensing to date U.S. assertion program continues in earnest, with 10 cases of infringement underway, including three against Big Pharma (Pfizer,
Slide 30: Financial Snapshot
Financial Snapshot Share Register Financials (3 months to September 30) Shares outstanding 581.4 million ADRs (@30:1 ratio) 19.4 million Top 20 shareholders 69.7% Total shareholders 2,903 Options outstanding 10.8 million (employees only) Market cap (@ $0.06) AUD 35 million (AUD millions) 2013 2012 R
Slide 31: 2014 Objectives
2014 Objectives Maintain focus on expansion of U.S. operations Increase U.S. sales force to cover all major U.S. sales territories Complete and launch “second generation” BREVAGenTM test to improve performance and increase market acceptance in the U.S. Broaden available ethnicities to expand availab
Slide 32: Tom Howitt, Acting CEO
Tom Howitt Acting CEO Genetic Technologies Limited Phone +61 3 8412 7000 Email info@gtglabs.com 32
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