Genetic Technologies Limited · ASX:GTG
Genetic Technologies — J.P. Morgan Annual Healthcare Conference 2014
33 slides from Genetic Technologies's conference presentation, Jan 8, 2014
Slide 1: ASX Announcement: US investor presentation
For personal use only 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
Slide 2: Breast Cancer Risk. An Emerging Market Segment. Corporate Overview
For personal use only Genetic Technologies presents: Breast Cancer Risk. Corporate Overview An Emerging Market Segment. January 2014
Slide 3: Forward Looking Statements
Forward Looking Statements For personal use only 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 ach
Slide 4: Corporate Overview
Corporate Overview For personal use only Revenue-generating global diagnostics business focused on women’s health TM Lead product is breast cancer risk test BREVAGen for non-familial (sporadic) breast cancer - Launched mid-2011 and now approved and available in all 50 U.S. states - U.S. CLIA app
Slide 5: Phenogen Sciences Inc.
Phenogen Sciences Inc. For personal use only 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 -
Slide 6: Established Infrastructure
For personal use only Established Infrastructure Genetic Technologies Limited Melbourne, Victoria, Australia Technical and corporate support with laboratory globally certified to ISO, RCPA, NATA and CLIA Phenogen Sciences Inc. Charlotte, North Carolina, U.S. Sales and marketing, customer support, re
Slide 7: Sales Mix by Business Unit
Sales Mix by Business Unit For personal use only U.S. Operations TM - BREVAGen 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 tes
Slide 8: BREVAGen
For personal use only 7 BREVAGen TM
Slide 9: What is BREVAGen?
For personal use only What is BREVAGen ? TM 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 pane
Slide 10: Scientific Support for BREVAGen
For personal use only Scientific Support for BREVAGen TM 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
Slide 11: Breast Cancer Risk: Early Detection Is Key
For personal use only 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 * Breast Cancer develops before it is detected * http://www.canc
Slide 12: Familial vs. Sporadic Breast Cancer
For personal use only Familial vs. Sporadic Breast Cancer A total of 235,000 breast cancer cases are diagnosed each year in the U.S. 80% of breast cancer is “sporadic” (meaning no strong family history) - An estimated 188,000 sporadic cases are reported each year BREVAGenTM focuses exclusively
Slide 13: BREVAGen Differentiated Integrated Risk Score
BREVAGen Differentiated Integrated Risk Score For personal use only TM 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
Slide 14: BCRAT / Traditional GAIL Score
BCRAT / Traditional GAIL Score For personal use only 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 fa
Slide 15: Cumulative Impact of Common, Low Risk Alleles
Cumulative Impact of Common, Low Risk Alleles For personal use only 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 16: BREVAGen's Clinical Difference
BREVAGen ’s Clinical Difference TM For personal use only 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/
Slide 17: Summary - The Benefits of BREVAGen
For personal use only Summary - The Benefits of BREVAGen™ 1. Improved Health Outcomes 2. Improved Cost Effectiveness when intervention and surveillance are appropriately applied to women at higher risk 16
Slide 18: BREVAGen Competitive Landscape
BREVAGen Competitive Landscape TM For personal use only 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
Slide 19: U.S. Market - Targeted Patient Profiles for BREVAGen
For personal use only U.S. Market - Targeted Patient Profiles for BREVAGen TM 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
Slide 20: BREVAGen Performance
BREVAGen Performance TM For personal use only BREVAGen Samples Received By quarter (launch to end of December 2013) 1200 1125 1000 914 800 599 600 368 403 400 200 178 142 113 78 84 0 2011/2012 - 2011/2012 - 2011/2012 - 2011/2012 - 2012/2013 - 2012/2013 - 2012/2013 - 2012/2013 - 2013/2014 - 2013/2014
Slide 21: The BREVAGen Ambassadors Program
For personal use only The BREVAGen Ambassadors Program TM 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 ad
Slide 22: BREVAGen Market Progress
For personal use only BREVAGen Market ProgressTM 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/Nebrask
Slide 23: Current Locations of U.S. Sales Force
For personal use only Current Locations of U.S. Sales Force 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
Slide 24: Sample Number Projections to June 30, 2015
Sample Number Projections to June 30, 2015 For personal use only BREVAGenTM Sample Number Projections Actual Forecast 8000 7000 6000 5000 4000 3000 2000 1000 0 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 23
Slide 25: Reimbursement Profile
For personal use only 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, bu
Slide 26: Reimbursement Improvement – Actions Being Taken
For personal use only Reimbursement Improvement – Actions Being Taken Additional studies to include: Clinical Utility Studies to drive Claim denials due to • Hispanic American MRI and/or Tamoxifen therapy “Experimental and Investigational” • African American • Expanded SNP panel Inclusion of BREVAGe
Slide 27: BREVAGen Product Development
For personal use only BREVAGen Product Development TM 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 cau
Slide 28: Corporate Summary
For personal use only 27 Corporate Summary
Slide 29: Management
For personal use only 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. i
Slide 30: Licensing Overview
Licensing Overview For personal use only 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
Slide 31: Financial Snapshot
Financial Snapshot For personal use only Financials (3 months to September 30) Share Register (AUD millions) 2013 2012 Shares outstanding 581.4 million Revenue / gains 1.1 1.4 ADRs (@30:1 ratio) 19.4 million Operations 1.0 1.0 Top 20 shareholders 69.7% Licensing 0.1 0.3 Total shareholders 2,903 Net
Slide 32: 2014 Objectives
For personal use only 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
Slide 33: Tom Howitt, Acting CEO
For personal use only Tom Howitt Acting CEO Genetic Technologies Limited Phone +61 3 8412 7000 Email info@gtglabs.com 32
Genetic Technologies — J.P. Morgan Annual Healthcare Conference 2014 on 6ix