Myriad Genetics Corporate Presentation -...

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Myriad Genetics Corporate Presentation 11/12/14

Transcript of Myriad Genetics Corporate Presentation -...

Page 1: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Myriad Genetics Corporate Presentation

11/12/14

Page 2: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Disclosure 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.

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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. 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 2015

GAAP diluted net income per share $1.75 - $1.85

Acquisition – amortization of intangible assets $0.15

Non-GAAP diluted net income per share $1.90 - $2.00

Page 3: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Well-Positioned Industry Leader

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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 major diseases

• Largest molecular diagnostic clinical laboratory in the world

• Global leader in hereditary cancer risk assessment

• Pioneer in personalized medicine and companion diagnostics

• Trailblazer in autoimmune disease management

• $778 million in FY2014 revenues (27% growth over FY2013)

Page 4: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Oncology

Preventive Care

Urology

Dermatology

Autoimmune

Neuroscience

The Myriad Vision

A TRUSTED ADVISOR ANSWERING PATIENT’S MOST PRESSING CONCERNS

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Page 5: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Multiple Growth Opportunities

Business Strategy

Transition Hereditary

Cancer Market

Diversify the

Portfolio

Expand Global

Presence

Fuel Strong Long-Term Top Line Growth 5

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Value of Identifying High Risk Patients

▪ Identifying hereditary disease saves lives

▪ Patients can take preventive measures to reduce risk of cancer

▪ Preventing cancer saves healthcare system money

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0%

50%

100%

ColorectalCancer Risk

EndometrialCancer Risk

BreastCancer Risk

OvarianCancer Risk

MelanomaRisk

5% 2%

12%

1% 2%

82% 71%

87%

44%

75%

1% 1% 5% 5% 1%

GeneralPopulation Risk

HereditaryCancer Risk

Risk WithPreventiveMeasures

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▪ 25 gene panel assesses cancer risk

▪ Over 50 million covered lives

▪ All genes are clinically actionable

▪ Identifies risks for eight cancers

▪ Finds 51% more people at risk for

breast cancer than BRCA

▪ Building database on all 25 genes

▪ Test accuracy is 99.99%

▪ $5 billion global market

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myRisk Hereditary Cancer™

Page 8: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Multiple Growth Opportunities

Business Strategy

Transition Hereditary

Cancer Market

Diversify the

Portfolio

Expand Global

Presence

Fuel Strong Long-Term Top Line Growth 8

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4in6 Pipeline Projects

Oncology

Preventive Care

Urology

Dermatology

Neuroscience

Risk? Diagnosis? Prognosis? Therapy?

Autoimmune

Currently Marketed

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1

1

1

1

1

2

1

1

1

6

1

1

# Under Development

2

Page 10: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Myriad Historic Publication Record

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0

50

100

150

Nu

mb

er

of

Pu

blic

atio

ns

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Product Pipeline

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Significant Revenue Growth Drivers

Mid Term 2-3 years

Long Term 3 years +

▪ myRisk HC ▪ Prolaris ▪ Vectra DA ▪ EndoPredict ▪ BRACAnalysis CDx ▪ Tumor BRACAnalysis

CDx

▪ myPath Melanoma ▪ myPlan Lung Cancer ▪ myChoice HRD ▪ myPlan Renal Cancer

▪ myChoice HRD (PARP) ▪ myPath BiPolar ▪ myRisk Schizophrenia ▪ Juvenile RA ▪ Psoriatic Arthritis ▪ Ankylosing Spondylitis

Near Term 1 year

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$5.0

$2.0

$1.0 $3.0

$6.0

$1.0

Global Market Size = $18 Billion

Future Global Market Opportunity

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myChoice HRD/BRACAnalysis CDx

myRisk HC Prolaris

Vectra DA myPath Melanoma

EndoPredict/myPlan Lung Cancer

Page 13: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

0%

25%

50%

75%

< 0 0-1 1-2 >2

7% 15%

30%

59%

Pro

stat

e C

ance

r D

eath

Ove

r 1

0 Y

ears

Prolaris Score

▪ 46 gene panel assesses aggressiveness of prostate cancer

▪ Most prostate cancer patients don’t require surgery

▪ 85% to 90% have treatment with side effects

▪ Validated in seven peer reviewed publications with gold standard outcomes of survival and metastases

▪ Prolaris changed treatment decisions for up to 65% of patients

▪ $2 billion global market

▪ Recently received draft LCD from Medicare covering the test for low risk patients

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PROLARIS®

PROLARIS® Predicts Prostate Cancer Survival

* Data presented at ASCO 2014

Patient Distribution

Page 14: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

0%

25%

50%

75%

100% 90% 91%

▪ 23 gene panel for diagnosis of melanoma

▪ Misdiagnosis is leading cause of malpractice suits

▪ Accurately differentiates between melanoma and benign skin lesions

▪ Effective for all four major melanoma subtypes

▪ myPath changed treatment decisions for 35% of patients

▪ 14% of biopsies in U.S. are indeterminate every year

▪ $1 billion global market

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myPath Melanoma™

myPath Accurately Identifies Melanoma Skin Cancer

* Data presented at ASCO 2014

Dif

fere

nti

atin

g M

elan

om

a

Fro

m B

enig

n L

esio

ns

Sensitivity Specificity

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▪ 12 protein panel measures disease activity in RA patients

▪ 1.5 million adults with rheumatoid arthritis in U.S

▪ Predicts irreversible joint damage in RA patients

▪ Guides treatment decisions

▪ 2-6 tests needed each year for rest of patient’s life

▪ myRA patient app facilitates patient monitoring

▪ $3.0 billion global market

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Vectra DA™

Clinical Features 62 years old RA for 4 years Seropositive DAS28-CRP = 1.7 (low) Current treatment Stable MTX

Clinical Features 59 years old RA for 5 years Seropositive DAS28-CRP = 1.9 (low) Current treatment Stable MTX

54 INCREASED

22 LOW

Vectra DA Score

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▪ 8 gene panel guides chemotherapy for breast cancer patients

▪ 60% of patients treated will not benefit from chemotherapy

▪ Test performed on site in cancer center

▪ No confusing intermediate results

▪ 13 clinical studies published with over 2,200 patients

▪ 250,000 breast cancer candidates in Europe each year

▪ $375 million European Market

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Met

asta

ses

Free

Su

rviv

al (

%)

* Data Published in Annals of Oncology 2012

Endopredict™

0.00

0.20

0.40

0.60

0.80

1.00

0 40 80 120

Low Risk High Risk

Months

EndoPredict Predicts Breast Cancer Survival

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0%

10%

20%

30%

40%

Low myPlanScore

High myPlanScore

18%

35%

Lun

g C

ance

r D

eath

Ove

r 5

Yea

rs (

%)

▪ 31 gene panel guides lung cancer chemotherapy

▪ Accurately predicts risk of dying from lung cancer

▪ Benefits patients with Stage 1 or Stage 2 lung cancer

▪ Stronger predictor than tumor size or stage of disease

▪ 34,000 early stage lung cancer patients in the U.S. every year

▪ $250 million global market

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myPlan Lung Cancer™

myPlan Predicts Lung Cancer Survival

* Validation of a Proliferation-based Expression Signature as Prognostic Marker in Early Stage Lung Adenocarcinoma (Bueno)

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▪ Identify cancer patients with tumors that lack the ability to repair DNA

▪ Likely to respond to DNA damaging agents (PARP or platinum drugs)

▪ 2,000,000 patients per year (U.S. & Europe) potentially eligible

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Companion Diagnostic Portfolio

• Journal of Clinical Oncology August 2010; British Journal of Cancer November, 2012

0%

10%

20%

30%

40%

50%

14% 22%

48%

Ovarian Cancer Patients Testing Positive

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CDx Development Projects Underway

PARP Inhibitors

• Current indications in Phase 3 clinical trials: TNBC, Neoadjuvant TNBC, Metastatic TNBC, adjuvant TNBC, neoadjuvant ovarian, MetBC Her 2-/ER+

• Current partners: ABBV, AZN, BMRN, Janssen (JNJ), TSRO, and other undisclosed partners

• Signed research collaboration with ABBV and TSRO

• Expect to announce Phase 3 clinical trials

• Signed research collaborations with TSRO and BMRN

• Expect to announce Phase 3 clinical trials

Platinum Therapies

• TNBC Neoadjuvant NA • TNBC Neo & Met BC

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▪ Test predicts patient response to PARP inhibitors

▪ PDUFA date for olaparib is scheduled for January 3, 2015.

▪ All four PMA modules submitted; FDA facility inspection complete.

▪ In nine Phase 3 clinical studies

▪ Studying PARP inhibitor benefit in ovarian, breast, lung, prostate, gastric, and pancreatic cancers

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BRACAnalysis CDx™

0.0

5.0

10.0

15.0

Olaparib Placebo

11.2

4.3

Pro

gres

sio

n F

ree

Su

rviv

al (

mo

nth

s)

BRCA Positive Patients Benefit from Olaparib

* Data presented at ASCO, 2013

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▪ Test predicts patient response to PARP inhibitors

▪ EMA CHMP label recommendation supports tumor testing; test launched in Europe

▪ Tumor testing finds up to 50% more responders than conventional germ line testing.

▪ Recently announced collaborations with Tesaro and AbbVie on Tumor BRACAnalysis CDx

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Tumor BRACAnalysis CDx™

0.0%

10.0%

20.0%

30.0%

Germ LineTesting

TumorBRACAnalysis

CDx

15.0%

22.0%

% o

f O

vari

an C

ance

r Pa

tien

ts

Wit

h a

Del

eter

iou

s M

uta

tio

n

Finds Up to 50% More Patients Who Will Respond

* Data presented at the European Society of Medical Oncology Meeting 2014

Page 22: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

▪ Test uses three technologies to predict patient response to:

Platinum Drugs

PARP inhibitor Drugs

▪ Current cancers being studied in clinical trials represent a 900,000 patient U.S. opportunity annually

▪ Only 30% of patients benefit from platinum drugs; high HRD patients have a 70% repsonse rate

▪ Launch scheduled for 2H FY2015

▪ $6 billion global market

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myChoice HRD™

0%

50%

100%

HRD Score> 10

HRD Score< 10

70%

12%

Pati

ents

Res

po

nd

ing

to C

isp

lati

n (

%)

myChoice HRD Predicts Chemotherapy Response

* Data presented at SABCS, 2012

Page 23: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Multiple Growth Opportunities

Business Strategy

Transition Hereditary

Cancer Market

Diversify the

Portfolio

Expand Global

Presence

Fuel Strong Long-Term Top Line Growth 23

Page 24: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

▪ 45 person European sales team

▪ Distributors in 80 countries

▪ Revenue up 109% in FY 2014

▪ Strong revenue growth from myRisk, Endopredict, BRACAnalysis, and Prolaris

▪ Launch of Vectra DA in 1H FY15

▪ Major opportunity with PARP inhibitors in European market

▪ $8 billion European market

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International Operations

Headquarters

Regional Offices

Laboratory

Spain

Italy

France

Germany

SW

UK

Page 25: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Delivering Strong Growth

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FY11 FY12 FY13 FY14

$402

$496

$613

$778

Revenue

FY11 FY12 FY13 FY14

$1.11

$1.30

$1.77

$2.43

Adjusted EPS

25% CAGR

30% CAGR

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Total Revenue 800 - 820

Adjusted Diluted EPS 1.90 - 2.00

Fiscal Year 2015 Guidance

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Revenue Guidance (Millions of Dollars)

Earnings Guidance (Dollars)

Page 27: Myriad Genetics Corporate Presentation - shareholderfiles.shareholder.com/downloads/MYGN/167011450x0x793726...GAAP diluted net income per share $1.75 - $1.85 Acquisition – amortization

Myriad Core Competencies

▪ Pioneer in Molecular Diagnostics:

▪ 13 proprietary molecular diagnostic products on market

▪ Commercial products in oncology, urology, rheumatology,

dermatology, and women’s healthcare

▪ Expert in all three biomarker technologies (DNA, RNA, and protein)

▪ Industry leading pipeline of 10 molecular diagnostic products

▪ Trailblazer in Personalized Medicine:

▪ First test to assess prostate cancer survival

▪ First test to assess rheumatoid arthritis disease activity

▪ First FDA approved complex companion diagnostic

▪ First companion diagnostic test to assess HRD

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