EX-99.2 3 d217284dex992.htm EX-99.2 EX-99.2

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Myriad Genetics Fiscal Fourth-Quarter 2016 Earnings Call 08/09/2016 Exhibit 99.2


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Forward Looking Statements 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. In this presentation, the Company’s financial results and financial guidance are provided in accordance with accounting principles generally accepted in the United States (GAAP) and using certain non-GAAP financial measures. The Company’s financial measures under GAAP include substantial one-time charges related to its acquisitions and ongoing amortization expense related to acquired intangible assets that will be recognized over the useful lives of the assets and charges related to executive severance. Management believes that presentation of operating results that excludes these items provides useful supplemental information to investors and facilitates the analysis of the Company’s core operating results and comparison of operating results across reporting periods. Management also uses non-GAAP financial measures to establish budgets and to manage the Company’s business. A reconciliation of the GAAP to non-GAAP financial guidance is provided below. Forward Looking Statements Non-GAAP Financial Measures Fiscal Year 2017 GAAP diluted earnings per share $0.47 - $0.57 Acquisition – amortization of intangible assets $0.36 Acquisition – one time charges $0.17 Non-GAAP diluted earnings per share $1.00 - $1.10 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/


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Fiscal Year 2016 Financial Results FY16 Actual Results YoY Growth Revenue $753.8M 4% Adjusted EPS $1.63 12% GAAP EPS $1.71 58%


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Hereditary Cancer Revenue Remains Relatively Stable Hereditary Cancer Revenue ($ in mil.)


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Substantial Progress With Key Pipeline Products Test Volume YoY Volume Growth New Private Payer Lives 15,300 94% 29M 160,000 11% 3M


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Extensive Collaborations With >22 PARP Clinical Studies NSCLC (240,000) Global Market > 1.4M patients or $6.0B* Neoadjuvant BC (143,000) Ovarian (60,000) FY15 FY16 FY17 FY18 FY19 FY20 *Includes U.S., Canada and EU6 Pancreatic (102,000) Metastatic Prostate (80,000) Colon (278,000) Gastric (114,000) Head & Neck (50,000) Metastatic BC (220,000) TNBC (90,000)


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Advancing Key Tests Toward Market Adoption Total Addressable Market (TAM) $10B+ $10B+ $15B $5B Product Stage 1 DISCOVERY Stage 2 VALIDATION Stage 3 REIMBURSEMENT Stage 4 ADOPTION myRisk® Hereditary Cancer BRACAnalysis CDx™ (Tumor) EndoPredict® myChoice™ HRD myPlan® Lung Cancer myRisk® Hereditary Cancer GeneSight® Psychotropic myPath® Bipolar myPath® Endometriosis Prolaris® myPlan® Renal Vectra DA® myPath® Psoriatic Arthritis myPath® Melanoma myPath® Psoriatic Arthritis GeneSight® Psychotropic myPath® Bipolar Oncology Preventive Care Urology Auto- Immune Derm. Neuro.


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Two Acquisitions Additive To Five Year Plan Global leader in genetic testing for drug selection in mental health market Core product is GeneSight®, which provides individualized treatment recommendations on 55 antidepressant, antipsychotic, and other mental health medications Currently call primarily on psychiatrists in the United States Testing services provided from Assurex’s CLIA laboratory in Mason, Ohio European kit manufacturer of high value diagnostics Core product is EndoPredict a breast cancer prognostic test Brings to Myriad substantial kit manufacturing and development expertise Myriad is the current exclusive distributor of EndoPredict in all countries except the U.S. and China Amount To Be Paid: $225M upfront $185M in milestones Total Addressable Market = >$18B Amount Paid: €35M upfront €15M in milestones Total Addressable Market = >$600M


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Fiscal Fourth-Quarter 2016 Revenue By Product Product 4Q16 4Q15 YoY Growth Hereditary Cancer $152.8 $163.8 (7%) Vectra DA $12.7 $11.8 8% Prolaris $3.5 $0.7 400% Other $4.8 $2.5 92% Total Molecular Diagnostic Revenue $173.8 $178.8 (3%) Pharmaceutical & Clinical Services $12.7 $11.1 14% Total Revenue $186.5 $189.9 (2%) (in millions)


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Fiscal Fourth-Quarter Financial Results 4Q16 4Q15 YoY Growth Total Revenue $186.5 $189.9 (2%) Gross Profit $146.5 $152.4 (4%) Gross Margin 78.6% 80.3% NA Operating Income $35.7 $36.2 (1%) Adjusted Operating Income $39.0 $48.2 (19%) Adjusted Operating Margin 20.9% 25.4% NA Net Income $23.4 $18.7 25% Diluted EPS $0.32 $0.26 23% Adjusted EPS $0.36 $0.41 (12%) (in millions except per share data)


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1Q17 and FY17 Financial Guidance Metric Fiscal First-Quarter 2017 Fiscal Year 2017 Revenue $168 to $170 million $740 to $760 million Diluted EPS $0.14 to $0.16 $0.47 to $0.57 Adjusted EPS $0.25 to $0.27 $1.00 to $1.10 For additional information on GAAP to non-GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-non-gaap-reconciliation/


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Hereditary Cancer Has Been Stable for Last 10 Quarters Hereditary Cancer Revenue (in mil.) Impact from celebrity publicity


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Guidance Assumptions for FY17 Potential Downsides Hereditary cancer out of network decisions Base Case Hereditary cancer decrease consistent with Q4 FY16 YoY decline No incremental payer coverage for Vectra DA, GeneSight, Prolaris or EndoPredict No revenue from myPath, myPlan Lung Cancer or myChoice HRD No U.S. EndoPredict revenue FY17 pharma & clinical services revenue < FY16 Three quarters of Assurex Health revenue Potential Upsides Hereditary cancer oncology share stabilizes New hereditary cancer indications provide growth Additional private payer or Medicare coverage for Vectra DA, Prolaris or GeneSight Primary care indication for GeneSight Revenue from myPath Melanoma, myPlan Lung Cancer or myChoice HRD UK, Canadian or German reimbursement for EndoPredict


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Market Expansion Opportunity in Hereditary Cancer Exceeds $1B Annually Indication Added Market Potential Guidelines Contracting Colon Cancer @ 5% Mutation Risk +$100M 53% All Endometrial Cancer +$150M 53% Breast Cancer <60 years +$150M FY17 FY18 All Pancreatic Cancer +$125M Partial FY17 Prostate Cancer +$120M Partial FY17 Colon Cancer Asymptomatic Market + $18B (6M patients) 53%


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Two Improvements to myRisk Hereditary Cancer Test Gene additions added to NCCN Guidelines in June 2016 GREMM1 POLE POLD1 25 Current myRisk genes NBN 1. Updating gene content to provide better care 2. Offering customizable format for customers


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PROMPT Study Show Discordance Between Hereditary Cancer Laboratories n=603 n=155 26% n=98 64% n=57 36% Conflicting interpretation between laboratories Non-clinically significant Altered surveillance recommendation Source: PROMPT Study presented at ASCO 2016 Annual Meeting ≈ 1 in 10 patients would have incorrect treatment recommendations


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New Product Pipeline Market Opportunity Currently Reimbursed Market Opportunity Total Market Opportunity (in billions) > $1B Reimbursed TAM


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Three New Commercial Contracts for Vectra DA and Prolaris Medicare Commercial Insurers 1.5 million RA patients 200,000 localized prostate cancer patients Commercial Insurers Medicare Favorable Int.


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EndoPredict Most Often Correct When Test Result Disagrees With Oncotype Dx *Data presented at San Antonio Breast Cancer Symposium in 2015 from the TransATAC cohort Oncotype Dx is a registered trademark of Genomic Health Inc. Non-Low 10.2% 29.9% Low 4.6% 26.9% Low High Rate of 10-year Distant Metastases Oncotype DX®


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GeneSight Is One of the Fastest Growing New Diagnostic Tests in History Less than 5% market penetration to date GeneSight (MYGN) Oncotype Dx is a registered trademark of Genomic Health Inc., FoundationOne is a trademark of Foundation Medicine Inc., Afirma is a trademark of Veracyte Inc.


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Most Major Depressive Disorder Patients are Seen in Primary Care Treating Physician for Patients With MDD Significant shortage of psychiatrists in U.S. and getting worse Most MDD patients are seen by primary care consisting of general practice, internal medicine, and OBGYNs Top 16,000 primary care physicians and OBGYN channel order almost half of the prescriptions for MDD ≈half of prescriptions ordered by 30,000 psychiatrists and primary care doctors


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Niraparib Highly Efficacious in Both myChoice HRD+ Patients and Germline BRCA+ Patients p<0.0001 ? 21.0 Progression Free Survival (Months) p<0.0001


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Extensive Collaborations With >22 PARP Clinical Studies NSCLC (240,000) Global Market > 1.4M patients or $6.0B* Neoadjuvant BC (143,000) Ovarian (60,000) FY15 FY16 FY17 FY18 FY19 FY20 *Includes U.S., Canada and EU6 Pancreatic (102,000) Metastatic Prostate (80,000) Colon (278,000) Gastric (114,000) Head & Neck (50,000) Metastatic BC (220,000) TNBC (90,000)


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Completing myPath Melanoma Reimbursement Dossier myPath Melanoma Diagnostic Accuracy myPath Melanoma Diagnostic Accuracy myPath Melanoma Clinical Utility n=437 patients n=736 patients n=218 patients Favorable outcomes study to be presented


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Building Towards >$600M Global Market for EndoPredict $31M $9M $52M $54M $50M $66M $305M FY20 Market Penetration Revenue 5% $33M 10% $66M 25% $165M Currently at about 10% market penetration in Germany and Switzerland $100M


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Incremental Revenue With Broad Reimbursement Revenue (in millions) Fully reimbursed at FY16 volume levels, Prolaris, Vectra DA, and GeneSight would drive > $300M in incremental revenue and > $2.00 per share in incremental earnings power


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Advancing Key Tests Toward Market Adoption Total Addressable Market (TAM) $10B+ $10B+ $15B $5B Product Stage 1 DISCOVERY Stage 2 VALIDATION Stage 3 REIMBURSEMENT Stage 4 ADOPTION myRisk® Hereditary Cancer BRACAnalysis CDx™ (Tumor) EndoPredict® myChoice™ HRD myPlan® Lung Cancer myRisk® Hereditary Cancer GeneSight® Psychotropic myPath® Bipolar myPath® Endometriosis Prolaris® myPlan® Renal Vectra DA® myPath® Psoriatic Arthritis myPath® Melanoma myPath® Psoriatic Arthritis GeneSight® Psychotropic myPath® Bipolar Oncology Preventive Care Urology Auto- Immune Derm. Neuro.