Latin American Pharmacogenomic Congress
"Delivering the value of personalized medicine to Physicians, Patients and Payors“
David Logan
Executive Vice President, Genomic Health, Inc.
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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, 2009. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.
NOTE: The Genomic Health logo, Oncotype, Oncotype DX™ and Recurrence Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
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"Delivering the value of personalized medicine to Physicians, Patients and Payors"
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• US Road map to providing a more precise tool (Oncotype DX™)
for making critical treatment decisions in early stage breast
cancer…
– Clinical Development and Validation
– Regulatory and Reimbursement Approaches
– Gaining Practice Guideline Recommendations
– Changing Clinical Practice
• International Road Map for Oncotype DX™
– World wide
– Latin America
Genomic Health, Inc
• Genomic Health, a life science company founded August of 2000
• Committed to improving the quality of cancer treatment decisions
• Clinical Reference Lab located in Redwood City, California
• Developed and follow a highly specialized process that (IVD/MIA);
• adheres to CAP (College of American Pathologists) standards
• is regulated by CLIA (Clinical Laboratory Improvement Amendments)
• First Product launched (Oncotype DX™ Breast $3,460) in 2004
• Over 9,000 Physicians have used Oncotype DX
• Over 150,000 patients have been tested to date (50,000 in 2009)
• Orders from over 55 countries
• 5 Product enhancements/new indications in 5 years
• 2009 Revenue $150 Million (Year over Year Growth >40%)
• Second Product (Oncotype DX™ Colon $3,200) in Feb. 2010
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Drug Development Spending is Significantly Outpacing ResultsThe Facts…U.S. Healthcare Costs Are Soaring"One-Size-Fits-All" Medicine is Not Sustainable, Does Not Deliver Optimal ValueCurrent Allocation of Healthcare Resources is Not Balanced for a Solution
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Source: Burrill & Company 2009 Biotech Report
In Vitro Diagnostics
Administration
Personnel Cost
Drugs
Procedures
12%
35%18%
35%
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Personalized Medicine, Center of the Conversation. Products like Oncotype DX have offered a solution
“Oncotype DX is evidence that personalized medicine can help reduce health costs, saving an average of $2,000 per patient in additional costs from chemotherapy
treatment.” – Dr. Francis Collins, Director of the National Institutes of Health
Personalized Medicine
Economy in Crisis
Healthcare Spending
Soaring
Healthcare Reform
TechnologyAccelerating
“We spend far more on treating illnesses that could have been managed for far less.”– President Barack Obama
Oncotype DX™: Unmet Clinical Need for Better Markers
Biopsy
or
Resection
Optimize
chemotherapy
Optimize local
therapy and
hormonal
therapy
Robust
Markers
High risk/Large chemo benefit
Low risk/Little chemo benefit
Our 1st Product was in Breast Cancer in 2004 Why was a personalized approach needed?
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1 For node-negative breast cancer (Lancet 1996 Apr 20; 347(9008):1066-71)* estimated
• In early stage Breast Cancer, Node (-), Hormone Positive (ER+) patients have ~15% rate of distant recurrence when treated with Hormonal therapy alone
• Chemotherapy benefit is modest in this setting (~4%)1 yet it is recommended for most patients by NCCN guidelines
• We needed an assay to identify a patients risk of distant recurrence AND who benefits from chemotherapy
• One size does not fit all!
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Candidate Gene SelectionFrom ~30,000 genes
250
cancer-related
candidate genes
*Sources include:
1) Van 't Veer et al, Nature 415:530, 2002
2) Sorlie et al, Proc. Natl. Acad. Sci. 98:10869, 2001
3) Ramaswamy et al, Nature Genetics 33:4, 2003
4) Gruvberger et al, Cancer Res. 61:5979, 2001
Paik et al, SABCS
rtPCR
NSABP B-20
Study,
Pittsburgh, PA
Rush Presbyterian,
Chicago, IL
Providence St.
Josephs Hospital,
Burbank, CA
The Most Robust (21) Genes were selected to go in Clinical Validation and Confirmation Trials
PROLIFERATION
Ki-67
STK15
Survivin
Cyclin B1
MYBL2
ESTROGEN
ER
PGR
Bcl2
SCUBE2
INVASION
Stromolysin 3
Cathepsin L2
HER2
GRB7
HER2
GSTM1
REFERENCE
Beta-actin
GAPDH
RPLPO
GUS
TFRC
Best RT-PCR performance
and most robust predictors
CD68
BAG1
Paik et al, SABCS
• 13 Key Peer Review
Publications
• Over 4,000 Patients
• Consistent Results
• Oncotype DX
identifies patients
more or less likely to
have a recurrence
AND who will benefit
from chemotherapy
The Oncotype DX® Recurrence Score is a Continuous Predictor of Recurrence Risk
Dotted lines represent 95% CI
Dis
tan
t R
ecu
rren
ce a
t 10 Y
ears
LOWER RISK HIGHER RISKWhat is the 10-year probability of distant recurrence
for a patient with a Recurrence Score of 30?
Recurrence Score
RS 30 = 20% risk of
distant recurrence at
10 years
Multiple Independent Studies Confirm -Decision Impact Supports Clinical Utility
Treatment Received by Recurrence Score1
1 Liang, SABCS 2007, Abstract #2061
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Building the Breast Cancer Franchise
Investment in Clinical Studies Expands Value to Patients
2008
Quantitative Single Gene
2007
Node Positive Recurrence,
Chemotherapy Benefit
2005
Node Negative Chemotherapy
Benefit2004
Node Negative Recurrence
Publications
• California Technology Assessment Foundation
• Agency for Healthcare Research and Quality
• Blue Cross Blue Shield Technology Evaluation Center• Approval of Appropriate Governmental Regulatory Bodies
• Analytic and Clinical Validity
• Clinical Utility must Improve Net Health Outcomes
• Benefit Beyond Established Measures
• Benefit Outside of Investigational Setting
• ASCO Guidelines
• NCCN Guidelines
• US Private Payor Coverage = 98%
• Medicare Coverage = 100%
92%8%
Low Risk
High Risk
NCCN Classification
49%
29%
22%
Low Risk
Intermediate Risk
High Risk
RT-PCR Assay
Reclassification
72%
6%
22%
Low Risk
Intermediate Risk
High Risk
RT-PCR Assay
Reclassification
Comparative Effectiveness: Relationship of NCCN vs. RS Directed Classification
Source: US adjuvant chemo usage data for early stage N- patients from OncoReport ICI; Oncotype DX data from
Genomic Heath
The Treatment Paradigm Has Changed
Key Milestones
• NSABP B14 Publica-tion
• NSABP B20 Presenta-tion
• Kaiser Presenta-tion
• Medicare Coverage
• NSABP B20, Kaiser Publicat-ions
• Aetna, United, Cigna Coverage
• ASCO and NCCN Guidelines
• SWOG 8814 Presenta-tion
• HER2, ER and PR Scores
• Node + Report
• Aromatase Inhibitors
• 90% U.S. Coverage
Consistent Adoption of our Product line.> 150,000 Patients benefited from Oncotype DX
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• Inter-national expansion
• Japanese Clinical Results
• Node + Medicare Coverage
• Latin Am. Expansion
0
10,000
20,000
30,000
40,000
50,000
60,000
70,000
2004 2005 2006 2007 2008 2009 2010
500
7,000
15,000
25,500
40,000
52,000
60-65K Est.
Our Integrated Service Model
Physicians
PatientsPayors
Direct-to-Oncology Sales
Reproducible Standardization
Publications – Evidence Driven
Guidelines – Evidence Supported
CME/Medical Staff
Outstanding Lab and Path Support
World Class Customer Service
Reimbursement Support
Patient Education Programs
Patient Advocacy
Patient Support - GAP
Managed Care
Evidence-Based Appeals
Effective Utilization Outcomes
Clinical Pathways
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Redwood City Clinical Reference Lab
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SARPCRM
SARPCRM
GEMTools (LIMS)
Material Manager
Data Services
OnBase EDI Services
Online Portal
EDI Services
Online Portal
Material Manager
HARP
PAS
Result Generation
Service
Report Delivery
Electronic Claim
ORDER ENTRY INTAKE PATHOLOGY ANALYTICAL
LABORATORYREPORT
FULFILLMENTMATERIAL RETURN
Insurance Provider
Order Entry
Benefits Investigation
Patient Information
Retrieval
SpecimenRetrieval
SpecimenAccessioning
Pathology Review
HistopathologyDissection
Extraction
Quantitation
gDNA Detection
Reverse Transcription
Results Generation
Billing
Report Delivery
MaterialsReturn
Reimbursement
Online, Fax FedEx
QPCR
Online Fax
Phone
Fax Request
FedEx FedEx
Our U.S. lab has processed tests from more than 55 countries to date.
A Personalized Medicine Approach Driving a New Standard of Care
•In Summary……
Product Pipeline - Positioned for Growth
Colon
Prostate
Breast
Renal
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Puerto Rico
• We placed a Representative in Puerto Rico 2009• > 60 MD’s have placed order• > 400 Patients have utilized Oncotype DX• Medicare patients and 100% Coverage• Triple S - Has a policy, working on a contract• Humana - Discussion ongoing (US Policy/Contract)• MSC – Has policy, working on contract
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International Expansion (2nd Year)
Countries that have submitted samples
Distribution partners
Sales/Consultants
Geneva Switzerland EU Office
1 Globocan 2002/ACS Cancer Facts & Figures 2007
Global incidence of breast cancer ~ 1.3 million patients1
Geneva Switzerland Office
Building the infrastructure. Establishing clinical experience and usage while advancing reimbursement submissions in targeted countries
Highlights:
• 56 Countries have ordered at least 1 assay• >8,200 Assays Launch to date• >1,100 Physicians • >50% YOY grow• 8 Ongoing studies (Utilization, Patient Selection)• Public and/or Private Coverage
• Germany (Public)• UK (Private)• Greece (Public)• Canada (Public, Province of Ontario)• Israel: (Public/Private)
• Patient (Cash) or Hospital payment is still the primary reimbursement
Latin American Presence & Progress: 2 Years of Effort – General Comments
• Awareness of Personalized Medicine: Hot Topic – The Promise of the future!
• Awareness of Oncotype DX: Growing with ~800 assays requested and by over >160 physicians and >50% YOY
• Treatment patterns and therapeutic options
– Less Early Stage patient presentation
– Adjuvant Treatment less aggressive (availability)
• Pathways to regulatory approval for IVD/MIA type products not always clear (FDA vs. CLIA)
• Public Reimbursement (~90%)- No Coverage to Date: Reason: Priorities, Access to Care, Pharmacoeconomics differ, Incentives favor treatment, patients pathway to coverage is difficult (legal petition)
• Private Coverage (10%) – encouraging: Private Insurers, Key Hospital and patient pay represent the early supporters of Oncotype DX
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Latin America Progress
Mexico
Seeking Partner /Study
Private Coverage: Hospital
Public Coverage: Pending
Promising: Mexican Social
Security Institute (IMSS) are
evaluating and Draft guidance
and Consenso Mexicano
(Secretaria de Salud) plan to
include Oncotype DX
Venezuela
Distributor: Fundacion BADAN
Private Coverage: Seguros
Caracas, Seguros Mercantil,
Sanitas de Venezuela,
Multinacional de Seguros
Public - IVSS (Social
Security) has paid first claim
Brazil / Study
Distributor: Diagnostika
Private market is
currently only viable
option for market entry.
Public: Not a current
option
Peru / Study
TAILORx study at the Instituto
Nacional de Enfermedades
Neoplasicas – Hospital Coverage
Colombia (+ Costa Rica and
Panama)
Distributor: Amarey Nova
Private Coverage: MCO’s -
Colsanitas and Saludcoop Argentina
Seeking Partner:
Will target Obras
Sociales (Unions) and
PAMI (Argentina
Medicare)
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Personalized Medicine is at the Center of the Conversation… Products like Oncotype DX offer a solution
“Oncotype DX is evidence that personalized medicine can help reduce health costs, saving an average of $2,000 per patient in additional costs from chemotherapy
treatment.” – Dr. Francis Collins, Director of the National Institutes of Health
Personalized Medicine
Economy in Crisis
Healthcare Spending
Soaring
Healthcare Reform
TechnologyAccelerating
“We spend far more on treating illnesses that could have been managed for far less.”– President Barack Obama
As the IVD/MIA Space Moves Foreward
• Regulatory Pathway• Standards in Tec Assessment – Levels of Evidence• Value Proposition and Pricing (CPT System)• Alignment of Incentives• Education• Access
Latin American Pharmacogenomic Congress
Thank You!