Myriad Genetics Corporate Presentation 6/4/13

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Transcription:

Myriad Genetics Corporate Presentation 6/4/13

Forward Looking Statement Some of the information presented here today may contain projections or other forward-looking statements regarding future events or the future financial performance of the Company. These statements are based on management s current expectations and the actual events or results may differ materially and adversely from these expectations. We refer you to the documents the Company files from time to time with the Securities and Exchange Commission, specifically, the Company s annual reports on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in the Company s projections or forward-looking statements.

Well-Positioned Industry Leader Myriad Genetics is dedicated to saving lives and improving the quality of life of patients through the discovery and commercialization of novel, transformative diagnostic tests across all major diseases Myriad is focused on every aspect of the disease process across the continuum of complete patient care Assessing risk of disease Ensuring rapid & accurate diagnosis Predicting progression Guiding treatment decisions

Multiple Growth Opportunities Business Strategy Growing Existing Markets Expanding Global Presence Launching New Products Fuel Strong Long-Term Top Line Growth

Broadening Disease Focus Current Markets Future Markets Preventive Care Urology Oncology Oncology Preventive Care Urology Dermatology Autoimmune Neuroscience Developing Tests Across Multiple Diseases

Myriad International Network Myriad products are now represented in > 80 countries by 40 distributors MYGN Direct Distribution MYGN Distributor Country

The Myriad Vision A TRUSTED ADVISOR ANSWERING PATIENT S MOST PRESSING CONCERNS RISK ASSESSMENT GUIDE THERAPY DIAGNOSIS COMPLETE PATIENT CARE PROGRESSION

First Patient Concern; What s My Risk? Identifying hereditary disease saves lives Future of genetic testing is pan-disease panels Myriad s myrisk Hereditary Cancer test will be first comprehensive pan-cancer panel 100% 75% 82% 71% 87% 75% General Population Risk 50% 44% Hereditary Cancer Risk 25% 0% 5% Colorectal Cancer Risk 1% 2% 1% Endometrial Cancer Risk 12% 5% 5% 1% 2% 1% Breast Cancer Risk Ovarian Cancer Risk Melanoma Risk Risk With Preventive Measures

Solution: myrisk Hereditary Cancer Product Profile: 25 gene panel (sequencing + large rearrangements) Clinically actionable genes (current genes + others) Initial focus on breast, colon, ovarian, endometrial, pancreatic, and melanoma Future expansion to lung, prostate, all cancers Turn around time 14 days or less List price between $4,000 and $4,500 Projected gross margin of 87%

myrisk Hereditary Cancer Market Expansion Eligible Patients Cancer Indications Health Economics Increased sensitivity expands criteria New genes expand cancer indications Comprehensive cancer risk report Improves health economics

Expansion Phase: New Indications ONCOLOGY CURRENT: 300,000 per year BREAST 30% COLON 25% OVARIAN 100% FY16: 600,000 per year BREAST 60% COLON 60% OVARIAN 60% ENDO 60% Pancreas 60% Melanoma 60% CANCER SCREEN = 1.6 MILLION PATIENTS

Differentiation Phase: Trusted Advisor Competitors Miss 60% of Positives Health Economics MUST KNOW True Positives prevent cancer True Negatives avoid unecessary screening and surgery FOUND MISSED (myrisk) MISSED (BART) MISSED (Database)

Solution: myrisk Hereditary Cancer Strategic Objectives: Launch in Fall of 2013 Convert entire hereditary cancer market by summer 2015 and discontinue BRACAnalysis, COLARIS, COLARIS AP, Melaris, and Panexia Proprietary Genes: Current: BRCA1, BRCA2, BART, RAD51C, PALB2, PTEN, MYH, P16 Future: MITF, ELAC2, others

Second Patient Concern; Do I Have Disease? Cancer diagnosis today involves considerable judgment Future of cancer diagnosis will use molecular diagnostics for more accurate detection 14% of All Skin Biopsies Are Indeterminate 14% Quicker and more accurate diagnosis like MelaPath saves lives and improves patient healthcare 86%

Third Patient Concern; How Aggressive is My Disease? Physicians have difficulty accurately predicting whether or not patient s disease will progress 100% PROLARIS Predicts Prostate Cancer Survival 90% Physicians don t know how aggressively to treat patients and frequently over-treat patients Molecular diagnostic tests like PROLARIS will save lives, improve quality of life, and reduce healthcare costs Prostate Cancer Survival Over 10 Years (%) 75% 50% 25% 0% Low PROLARIS Score 22% High PROLARIS Score

PROLARIS Competitive Advantages PROLARIS Indications Biopsy, Prostatectomy Outcome Predicted Patients Studied Gold standard outcomes: Risk of PrCa-specific mortality, metastasis, biochemical recurrence Over 3,000 Published Studies Add l Studies Presented Heterogeneity Sample Requirements 4 + 1 accepted 4 Genes show little regional variability Smallest in the industry (20 microns)

Queen Mary University of London Study Published in the British Journal of Cancer 100% Study Details N=349 patients Sample type: Biopsy Outcome: Survival Published in the BJC 10-Year Survival 75% 50% 25% 80% 25% 0% Low-Risk PROLARIS Score High-Risk PROLARIS Score

PROLARIS Progress To Date Received over 3,000 orders in the last 12 months Significantly better than any other cancer prognostic launch Approximately 90% of current samples are biopsy tissue Received samples from over 350 urologists 24 person sales force PROCEDE data to Medicare by summer 2013 Medicare reimbursement expected in CY14

Fourth Patient Concern; What Therapy is Best? Many medicines today are prescribed on a trial and error basis Only about 30% of cancer patients will benefit from any particular chemotherapy Future of drug development is using companion diagnostics to identify responders and non-responders Technology is progressing beyond single-gene biomarkers to focus on disease pathways like Myriad s HRD test Percent of Patients Responding 100% 75% 50% 25% 0% Carboplatin Based Therapy 70% 12% HRD Score > 10 HRD Score < 10

Inability to Repair DNA Prevalent in Major Cancers Ovarian tumors (n=747) Esophagus tumors (n=51) Lung tumors (n=226) Brain cell lines (n=19) Prostate tumors (n=23) Colon cell lines (n=42) 490,000 Candidate Patients Per Year = $1B to $2B U.S. Market Opportunity 0% 5% 10% 15% 20% 25% 30% 35% 40% 45% 50% % of Samples With HRD Score > 10

Multiple Companion Diagnostic Partnerships Multiple Billion Dollar Markets 8 3 3 Pre-IND Phase 1 Phase 2 Phase 3 Post- Marketing Stage Projects Areas Phase II 8 Oncology, Neuropsychiatry Phase III 3 Neuropsychiatry Post-Marketing 3 Neuropsychiatry, Kidney Damage

AstraZeneca PARP (Olaparib) Launch: 2015 Olaparib in ovarian cancer: EMA filing in 2013, launch in 2015 EU opportunity for BRCA testing ~30,000 tests/year or $120 million/year Requires BRCA testing with high accuracy & fast turnaround time (< 14days and < 3% VUS rate) Other Solid Tumors Lung Cancer Ovarian Cancer HRD Impaired Cancer Gastric Cancer Advanced Breast Cancer Early TN Breast Cancer Opportunities beyond ovarian cancer Myriad is only Company that can achieve turnaround times and accuracy needed for a companion launch

Projected Change in Market Opportunity 2013 Global Market Size = $4.2 Billion 2018 Global Market Size = $12.1 Billion $0.4 $1.8 $0.7 $1.2 $2.0 $0.8 $1.4 $3.0 $5.0 BRACAnalysis COLARIS myrisk Cancer PROLARIS Other HRD MelaPath

Historical Financial Performance $600 Revenue Growth $200 Operating Income $500 $400 $300 $200 22% CAGR $150 $100 $50 31% CAGR $100 FY08 FY09 FY10 FY11 FY12 $0 FY08 FY09 FY10 FY11 FY12 PF EPS Quarterly ROIC $1.50 $1.25 $1.00 27% CAGR 26.0% 24.0% 22.0% 21.1% 24.0% 23.2% 23.5% $0.75 20.0% $0.50 18.0% $0.25 FY08 FY09 FY10 FY11 FY12 16.0% 4Q12 1Q13 2Q13 3Q13

Fiscal Year 2013 Guidance Range Growth MDx Revenue: $560M - $572M 19-21% CDx Revenue: $25M - $28M 19-27% Total Revenue: $595M - $600M 20-21% Diluted EPS: $1.65 - $1.67 27-28%

Myriad Core Competencies Content Driven Company: Leader in disease profiling Pioneer in understanding cancer risk: Launch myrisk Hereditary Cancer test this fall First comprehensive pan-cancer panel Innovator in companion diagnostics: Launch HRD test in CY2015 for platinum therapies Will revolutionize cancer treatment Trailblazer in guiding threapy: Over 3,000 PROLARIS test orders year-to-date Expect broad reimbursement coverage within 12 months Most Comprehensive Capabilities: Multiple biomarker tools (DNA, RNA, and protein)