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Personalized Medicine Disruptive Technology? David Logan Senior Vice President, Commercial Genomic Health Inc
Safe Harbor Statement This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements related to future periods, can be identified by words such as believes, anticipates, plans, expects, will, intends and similar expressions, and may include our future plans and prospects and our product pipeline. Forward-looking statements are subject to risks and uncertainties which may cause actual results to differ materially. For a discussion of the factors that may cause our results to differ, please refer to our filings with the Securities and Exchange Commission, including our [Annual Report on Form 10-K for the year ended December 31, 2008] [Quarterly Report on Form 10-Q for the quarter ended March 31, 2009]. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements. 3 3
What is Personalized Medicine? Personalized medicine is when disease happens to you!
Focused on Fundamentals Proving the Value of Personalized Medicine Improve the quality of treatment decisions for patients with cancer Leader in genomic analysis of tumor biopsies Turning Value into Profit 5 5
Personalized Medicine Moves to Center of Global Healthcare Solution We spend far more on treating illnesses that could have been managed for far less. President Barack Obama Economy in Crisis Technology Accelerating Personalized Medicine Healthcare Reform Healthcare Spending Soaring 6 6
Sequencing the Genome was Just the Beginning of an Information Wave Information The Genetic Code DNA RNA Protein Pathways Complexity 7
Genomics today is tracking like the computer industry in the 1970s -- at the beginning of a consumer revolution... 22 24 26 28 30 32 34 36 38 40 192 191 189 190 188 186 187 185 183 184 182 180 181 179 177 178 176 174 175 173 171 172 170 168 169 167 165 166 164 162 163 161 159 160 158 156 157 155 153 154 152 150 151 149 147 148 146 144 145 143 141 142 140 138 139 137 135 136 134 132 133 131 129 130 128 126 127 125 123 124 122 120 121 119 117 118 116 114 115 113 111 112 110 108 109 107 105 106 104 102 103 101 99 100 98 96 97 95 93 94 92 90 91 89 87 88 86 84 85 83 81 82 80 78 79 77 75 76 74 72 73 71 69 70 68 66 67 65 63 64 62 60 61 59 57 58 56 54 55 53 51 52 50 48 49 47 45 46 44 42 43 41 39 40 38 36 37 35 33 34 32 30 31 29 27 28 26 24 25 23 21 22 20 18 19 17 15 16 14 12 13 11 9 10 8 6 7 5 3 4 2 1 22 24 26 28 30 32 34 36 38 40 Cycle Threshold (CT) Moore s Law + Metcalfe s Law + Finite Biology Technology is miniaturizing -- cost per gene analyzed is down and increasing information is available The utility of genomic information is accelerating as researchers, patients and physicians begin to network Number of genes involved in disease are finite and the time required to fit the pieces into a finite puzzle is decreasing rapidly = Personalized Medicine 8
The Oncotype DX Breast Cancer Assay Addresses Critical Clinical Question for Non-Metastatic Patients Chemotherapy benefit is modest in the adjuvant setting (~4%)* Oncotype DX - predicts the likelihood of breast cancer recurrence in women with newly diagnosed, early stage invasive breast cancer - assesses the likely benefit from both hormonal therapy and chemotherapy Independent studies verify that Oncotype DX use impacts treatment decisions 9 *Lancet 1996 Apr 20;347(9008):1066-71 Genomic information is shifting the treatment paradigm for breast cancer 9
The Oncotype DX Recurrence Score is a Continuous Predictor of Recurrence Risk What is the 10-year probability of distant recurrence for a patient with a Recurrence Score of 30? Distant Recurrence at 10 Years RS 30 = 20% risk of distant recurrence at 10 years Dotted lines represent 95% CI Recurrence Score 10
Oncotype DX Breast Cancer Assay Oncotype DX provides valuable information on: Clinical prognosis Predicted chemo benefit Quantitative data on ER / PR / HER2 Node positive patients 11
Rapidly Growing Adoption Annual Oncotype DX Worldwide Test Results Delivered 40,000 35,000 39,600 30,000 25,000 20,000 24,500 15,000 10,000 14,500 5,000 0 500 7,000 2004 2005 2006 2007 2008 Key Milestones NSABP B14 Publication NSABP B20 Presentation Kaiser Presentation Medicare Coverage NSABP B20, Kaiser Publications Aetna, United, Cigna Coverage ASCO and NCCN Guidelines SWOG 8814 Presentation HER2, ER and PR Scores Node + Report Aromatase Inhibitors 95% U.S. Coverage 12 12
Investment in Delivering World Class Service ORDER ENTRY INTAKE PATHOLOGY ANALYTICAL LABORATORY REPORTS FULFILLMENT MATERIAL RETURN Online Fax Insurance Provider Phone Fax Request FedEx FedEx Benefits Investigation Specimen Retrieval Pathology Review Extraction Quantitation Results Generation Report Delivery Materials Return Order Entry Patient Information Retrieval Specimen Accessioning Histopathology gdna Detection Reverse Transcription QPCR Billing Reimbursement Online, Fax FedEx SARP CRM GEMTools (LIMS) SARP CRM OnBase EDI Services Material Manager Result Generation Service EDI Services Material Manager Online Portal Data Services Report Delivery Online Portal Electronic Claim PAS HARP 13 13
Genomic Health Accomplishments are Contributing to a New Standard of Care in Cancer Diagnosis and Treatment Planning Rapid growth in Oncotype DX Breast adoption and revenue >100,000 tests delivered >8,000 Physicians have used Oncotype DX Recommended in ASCO and NCCN clinical guidelines >95% of U.S. insured lives covered by payors (BCBS Tec Approved) Expanded utility of Oncotype DX Node positive patients ER, PR and HER2 single scores Aromatase inhibitor-treated patients Over 4,000 patients in 13 clinical trials with validation studies conducted in the US, EU, and Japan. Breast Cancer tissues samples received from 40 countries 14 14
Long Road to Standard of Care We believe well designed clinical trials resulting in published (Peer Reviewed) meeting the needs of the patient, providers and payors will lead to Standard of Care 15 Standard of Care Guidelines Reimbursement Physician Adoption KOL S / Advocates Publications Clinical Validation
Bringing Personalized Medicine to the Forefront for Breast Cancer Patients. Obstacles? Adoption driven by the Peer Review publications and accelerated with ASCO and NCCN guidelines Reimbursement acceptance ( 95% coverage for Node Negative, ER+ Breast Cancer) driven by Payor Tec Assessments. Analytical Validity Clinical Validity: Prospective vs. Prospective End Points Clinical Utility and Actionability Comparative Utility Pathway to the Market for IVD/MIA tests CLIA vs. the FDA Billing and Coding CPT codes vs. MISC and S Codes Pharmacoeconomics - Value Pricing Cost Effective or even Cost Savings? 16
Disruptive? Changing established Medical Oncology treatment patterns Managing the impact of Provider revenue disruptions Pathologists understanding of how Oncotype DX fits into their space? Competing or Complementing? Kits vs. Centralized Lab? Tissue access, selection, ownership, and control Turn Around Time for results and Time to Block return Medicare Date of Service Rule for Archival Specimens, who is responsible for billing? Lab and Hospital Services facilitate send outs without compensation 17
CAP 2008: Call to Action transformation of the specialty of pathology Understand that your value is beyond diagnosis & also should center on influencing prevention, prognosis & treatment - Dr. Jared Schwartz, President of CAP Oncotype DX is a important piece of the puzzle that will assist providers and patients in making treatment decisions. It is not the whole puzzle. Pathologists play a critical role in completing the puzzle. Continue to embrace personalize medicine Be a source of expert on available clinically valid tests Serve as interpreter & consolidator of results Help guide & educate multidisciplinary breast oncology teams Work with reference labs to streamline process Insure appropriate payment for your services 18
Collaboration To facilitate a collaborative effort, Genomic Health provides: Knowledge to assist in the patient treatment decision: We have 15 Physicians (11 Pathologist) interfacing on a regular basis with Pathologist, Surgeons and Medical Oncologist Our Pathologist use the Aperio digital pathology system Supporting the process and the patient: Customer Service (65) Reimbursement Support Services (90) Field Genomic Liaisons (80) Hospital contracting group (14) Peer to Peer CME education support for Pathologist /Lab staff 19
Collaboration In the Future we are looking at: Continuing to add value to Oncotype DX Stronger collaboration with Pathologist and Labs Miniaturization and/or Kits? Streamlining: Treatment Pathways and EMR Partnerships, research and commercial - Publications More efficient ways to reimburse you for your services Ways to implement the Aperio system with our customers to improve the quality of our assay and result Continued work on billing and coding for value Working with Hospitals, Societies, Advocates, CMS and Washington to address the DOS or 14 day rule Continued work with Pathologists, Lab associations and Trade groups to provide input to the FDA and CLIA on the commercial pathways for IVD/MIA s 20
Future Directions in Breast Cancer Oncotype DX N-, ER+ Breast Cancer Recurrence Node-Positive Breast Cancer Taxane Response DCIS CMF Chemotherapy Benefit Anthracycline Chemotherapy Benefit TAILORx Trial Results Tamoxifen Benefit Aromatase Inhibitors (ongoing) Other Targeted Therapies Quantitative Single Gene Reporting ER-Negative Breast Cancer 21
Growing Product Pipeline 2009-2010 1 MattsonJack DaVinci 2004, 2007; 2 Globocan 2002/ACS Cancer Facts & Figures, 2008. 22
Vilma M. Oncotype DX Patient Thank You! 23
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