Myriad Genetics Fiscal First-Quarter 2019 Earnings Call 11/06/2018

Similar documents
Myriad Genetics Fiscal First-Quarter 2017 Earnings Call 11/01/2016

Myriad Genetics Corporate Presentation 06/13/2018

Myriad Genetics Fiscal Third-Quarter 2017 Earnings Call 05/02/2017

Myriad Genetics Fiscal Second-Quarter 2017 Earnings Call 02/07/2017

Myriad Genetics Corporate Presentation 6/4/13

Media Contact: Ron Rogers Investor Contact: Scott Gleason (801) (801)

Genomic Health. Kim Popovits, Chairman, CEO and President

37 th ANNUAL JP MORGAN HEALTHCARE CONFERENCE

Uroplasty, Inc. Investor Update Canaccord Genuity Conference December 6, 2011

Diagnostics for the early detection and prevention of colon cancer. Fourth-Quarter 2014 Earnings Call February 24, 2015

Natus Medical Incorporated. Jeffries Global Healthcare CONFERENCE Tuesday June 6, 2017

J.P. Morgan. 27 th Annual Healthcare Conference. San Francisco January 14 th, 2009

Bank of America 38 th Annual Investment Conference. San Francisco, CA September 17 th, 2008

Forward Looking Statements

Corporate Presentation. August 2016

Clovis Oncology Announces Q Operating Results and Corporate Update. November 3, :05 PM ET

4 th Quarter 2017 Earnings Review & Investor Update

BALCHEM CORPORATION. Q Investor Relations Presentation

ST. JUDE MEDICAL / THORATEC TRANSACTION HIGHLIGHTS July 22, 2015

January 30, 2018 Dow Wilson President and Chief Executive Officer

Cowen Healthcare Conference March 12, 2018

Corporate Presentation Fourth Quarter 2017

36th Annual J.P. Morgan Healthcare Conference. Kevin Conroy, Chairman and CEO January 9, 2018

34 th Annual J.P. Morgan Healthcare Conference

Visionary Private Equity Group is Pleased to Announce its Investment in MEDITE Cancer Diagnostics

Myriad Genetics mychoice HRD Update 06/30/2016

Personalized Medicine Disruptive Technology? David Logan Senior Vice President, Commercial Genomic Health Inc

Walgreen Co. Reports Second Quarter 2010 Earnings Per Diluted Share of 68 Cents; Results Include 2 Cents Per Diluted Share of Restructuring Costs

Clovis Oncology Announces First Quarter 2017 Operating Results. May 3, :06 PM ET

Diagnostics for the early detection and prevention of colon cancer. Leerink Swann Global Health Care Conference February 2015

(MYGN - $34.67 NASDAQ)

Universal Biosensors, Inc.

4Q and Full Year 2017 Financial Results Call February 7, 2018

Jefferies Healthcare Conference June 6, 2018

DARA Reports Year-End 2012 Financial Results

Merrill Lynch conference. Matthew Emmens, CEO Shire plc September 20, 2007

A world leader in allergy immunotherapy

August 7, Q Financial Results

VolitionRx Announces First Quarter 2016 Financial Results and Business Update

TELECONFERENCE Q August 2015

Molecular Diagnostic Solutions for Urologic Cancer

Developing & Commercializing Targeted Small Molecule Drugs in Cancer

The MGH Journey. Shaping the Future of an Entire Region

Intercept Pharmaceuticals Reports Second Quarter 2017 Financial Results and Provides Business Update

AVEO Oncology Announces Strategic Restructuring. AVEO to Host Conference Call Wednesday, June 5 at 8:30 a.m. ET

Cepheid The MDx Growth Leader. William Blair Growth Stock Conference June 12, 2012

Monogram Announces 2008 Second Quarter Financial Results

AstraZeneca to Acquire Bristol- Myers Squibb Share of Global Diabetes Alliance. Becoming Global Leaders In Diabetes

FOR IMMEDIATE RELEASE Media Contact: Lainie Keller Investor Contacts: Teri Loxam (908) (908) Amy Klug (908)

Investor Presentation. Q April 26, 2018

Second Quarter and First Half 2011 Conference Call. 29 July, SORIN GROUP Presentation 1

USPSTF Draft Recommendations Investor Call. October 6, 2015

Bank of America Merrill Lynch HealthCare Conference Bayer HealthCare Dr. Jörg Reinhardt. September 14, 2011

First Albany Orthopedics Conference Marina Village, San Diego February 13, 2007 Orthofix International

ALLERGAN TO ACQUIRE ZELTIQ FOR $2.47B BEST-IN-CLASS COMPANY IN FAST GROWING BODY CONTOURING SEGMENT

Forward Looking Information

21 st Annual Needham Growth Conference

Acquisition of Novartis Influenza Vaccines Business. 27 th October 2014

Forward Looking Statements and Further Information

Jefferies Healthcare Conference. June 6, 2018

Incyte Reports 2014 Second Quarter Financial Results and Updates Shareholders on Key Clinical Programs

When the question is genetics, the answer is Invitae Invitae Corporation. All Rights Reserved. 1

FOURTH QUARTER AND FULL YEAR 2018 FINANCIAL RESULTS AND BUSINESS UPDATE. Thursday, February 7, 2019

SPHERIX ANNOUNCES FIRST QUARTER 2010 FINANCIAL RESULTS

1Q Fornebu, April 29, 2015 Luis Araujo and Svein Stoknes

Putting ALK on the right growth trajectory

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics. William Annett Chief Executive Officer

Closing of Nucletron acquisition Building a stronger position in the cancer care market. September 15, 2011

COMPANY OVERVIEW. April 26, 2018

Slide 1. International Operations update. Mike Doustdar EVP International Operations. YASMIN FIEDLER, Germany Yasmin has type 1 diabetes

LEERINK GLOBAL HEALTHCARE CONFERENCE. Marino Garcia EVP, Chief Strategy Officer February 15, 2017

MDxHealth. Strong outlook for Research Note.

Corporate Presentation. June 2017

Coloplast A/S. Investor presentation 1H 2005/06

2018 Edition The Current Landscape of Genetic Testing

Liquid Biopsies. Next Generation Cancer Molecular Diagnostics

ResMed Inc. 36 th Annual J.P. Morgan Healthcare Conference

TELECONFERENCE FY February 2015

OBALON THERAPEUTICS, INC. (OBLN) The first and only FDA-approved swallowable, gas-filled intragastric balloon for weight loss

FY2007 Consolidated Financial Overview

Investor Presentation. Q October 26, 2017

Small-Cap Research. VolitionRx Ltd (VNRX-NYSE) VNRX: More Positive Data in Colon/Lung Cancers. Anticipating Initial Launch This Year OUTLOOK

J.P. Morgan Healthcare Conference

DIEBOLD NIXDORF AG AT GERMANY EQUITY FORUM

NewLink Genetics Corporation Provides Operational Update and Reports Second Quarter 2015 Financial Results

Supernus Pharmaceuticals

Guardant Health Investor Presentation. January 2019

Investor Presentation. Q May 21, 2018

FDA Companion Diagnostic Testing and Implications for Pharmacy and Medical Directors

- Plans Commercial Launch of three dosing options for Excellagen in pre-filled syringes

(GALE-NASDAQ) OUTLOOK

Forward-Looking Statements

Bank of America Merrill Lynch Global Healthcare Conference 2012

Interim report Second quarter 2017 and subsequent events (Unaudited)

Corporate Presentation. First Quarter 2018

TELECONFERENCE Q November 2015

Lung Cancer Screening

BancAnalysts Association of Boston Conference Presentation. November 3, 2017

Medifocus, Inc. OTCQX: MDFZF TSXV: MFS

Slide 1. Investor presentation. London 5 February 2019

Transcription:

Myriad Genetics Fiscal First-Quarter 2019 Earnings Call 11/06/2018 Copyright 2017 2018 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 1

Forward Looking Statements 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 forwardlooking statements. Non-GAAP Financial Measures Financial Guidance Fiscal Year 2019 GAAP diluted earnings per share $0.40 - $0.45 Acquisition amortization of intangible assets $0.80 Stock based compensation expense $0.30 Adjustments to GAAP financial measures $0.20 Non-GAAP diluted earnings per share $1.70 - $1.75 For additional information on GAAP to non- GAAP reconciliation see: https://www.myriad.com/investors/gaap-to-nongaap-reconciliation/ 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 link to reconciliation of the GAAP to non-gaap financial guidance is provided above. Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 2

FY 2019 First-Quarter Financial Results 1Q19 Actual Results 1Q18 Actual Results YoY Change Revenue (in mil.) $202.3 $178.8 13% GAAP EPS ($0.01) $1.12 NM Adjusted EPS $0.43 $0.29 48% Organic Adjusted EPS* $0.52 $0.29 79% *Excludes $0.09 of dilution from the Counsyl acquisition in the fiscal first quarter Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 3

Critical Success Factors to Achieving Strategic Goals STRATEGIC GOALS >10% Revenue Growth >30% Operating Margin 7 Products >$50M >10% International Revenue CRITICAL SUCCESS FACTORS Build upon a solid hereditary cancer foundation Grow new product volume Expand reimbursement coverage for new products Increase RNA kit revenue internationally Improve profitability with Elevate 2020 Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 4

Hereditary Cancer Revenue Solid Hereditary Cancer Foundation Seven Quarters of YoY Volume Growth With Stable Pricing $150 $100 $50 $0 1Q18 2Q18 3Q18 4Q18 1Q19 7 sequential quarters with YoY volume growth 4 sequential quarters with stable pricing Double-digit volume growth from patients with less severe family histories due to riskscore Filed supplementary PMA for BRACAnalsysis CDx in first-line maintenance for ovarian cancer 2 nd FDA approval for BRACAnalysis CDx in met BC with Pfizer s drug TALZENNA New research collaboration with Pfizer in neo-adjuvant TNBC 5

GeneSight Volume Ordering Doctors Record GeneSight Ordering Physicians Continued Strong Volume Trends With 28% Year-Over-Year Growth 100,000 GeneSight Volume 20,000 Ordering Physicians 28% Growth 35% Growth Over 15,500 ordering doctors in 4Q18 0 1Q17 1Q18 1Q19 0 1Q17 1Q18 1Q19 6

Prenatal Test Volume Continued Strong Prenatal Volume Trends Significant Opportunity for Sales Synergies in 2H FY19 100,000 Prenatal Test Volume 16% YoY Volume Growth 0 1Q17 1Q18 1Q19 7

Advances in Reimbursement Coverage For New Products New Product Reimbursement 1.6B in Potential Revenue Current U.S. Coverage RAM EndoPredict Prolaris Vectra GeneSight mypath Melanoma $240M $330M $720M $300M $4M GeneSight GUIDED study acceptance expected in Q2 FY19 GeneSight IMPACT and Optum Health studies published Blue Shield of California covers Prolaris increasing total commercial lives to 24 million Received draft LCD from Medicare for mypath Melanoma Received positive Bendcare guidelines for Vectra 0% 25% 50% 75% 100% Reimbursed Addressable Market (RAM) 8

Continued Expansion in Prolaris Reimbursement 9 Commercial Payers Now Cover the Test Totaling 24 Million Lives U.S. Prolaris Insurance Coverage (56%) 225 Medicare Low & Favorable Sales Reps Intermediate 80 Sales Reps Commercial Insurers 24 million commercial lives under coverage Medicare Private Covered Private Non-Covered Medicare Non-Covered 9

International Developments Kit-Based Strategy With Restructuring to Global LDT Laboratory Revised NICE draft guidance document on breast cancer prognostics recommends EndoPredict as one of three diagnostic tests final guidelines anticipated by end of CY18 All laboratory developed tests expected to be transitioned to SLC by end of CY18 resulting in closing of Munich laboratory Late-stage discussion with German clinic buyer Filing for regulatory approval in Japan for HBOC with BRACAnalysis would be only approved test in 3.3M patient market 10

Organic Total Expenses ($M) Organic Adjusted Operating Margin Improve Profitability With Elevate 2020 Adjusted OM Improves 550 BP Since Start of Elevate 2020 $160 $155 Organic Expenses Organic Adj. OM FY18 Targeted 24.0% Savings = $17M 26% 24% 22% $150 $145 18.5% 20% 18% $140 $135 16% 14% 12% $130 4Q17A 1Q18A 2Q18A 3Q18A 4Q18A 1Q19 10% 11

FY 2019 First-Quarter Revenue By Product (in millions) Product 1Q19 1Q18 YoY Growth Hereditary Cancer $116.3 $117.0 (1%) GeneSight $29.3 $28.8 2% Prenatal Testing $18.1 $0.0 NM Vectra $13.0 $14.0 (7%) Prolaris $6.2 $3.9 59% EndoPredict $2.4 $1.8 33% Other $3.7 $1.9 95% Total Molecular Diagnostic Revenue $189.0 $167.4 13% Pharmaceutical & Clinical Services $13.3 $11.4 17% Total Revenue $202.3 $178.8 13% Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 12

Fiscal First-Quarter Financial Results Adjusted Earnings Per Share Increase 48% Over Q1 FY2018 GAAP Results Adjusted Results 1Q19 1Q18 YoY Growth 1Q19 1Q18 YoY Growth Total Revenue $202.3 $178.8 13% $202.3 $178.8 13% Gross Profit $152.6 $135.8 12% $155.9 $136.1 15% Gross Margin 75.4% 76.0% -160 bps 77.1% 76.1% +100 bps Operating Income $1.2 $84.0 (99%) $37.1 $27.7 34% Operating Margin 0.6% 47.0% -4640 bps 18.3% 15.5% +280 bps Net Income ($0.7) $78.8 NM $32.8 $20.5 60% EPS ($0.01) $1.12 NM $0.43 $0.29 48% Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 13

FY19 and 2Q19 Financial Guidance Metric Fiscal Year 2019 2Q19 Revenue $855 to $865 million $216 to $218 million GAAP Diluted EPS $0.40 to $0.45 $0.06 to $0.08 Adjusted EPS $1.70 to $1.75 $0.36 to $0.38 Copyright 2017 Myriad Genetics, Inc., all rights reserved. www.myriad.com. 14

Potential Upside Drivers to Guidance Reimbursement and Counsyl Revenue Synergies Material Opportunity GeneSight commercial payer coverage decisions and expanded Medicare LCD Revenue synergies from the Counsyl acquisition in the second half of fiscal year 2019 Return to in-network status with UNH for prenatal tests Higher than anticipated hereditary cancer revenue due to Pfizer met BC launch, FDA approval for BRACAnalysis CDx in first-line maintenance for ovarian cancer, and Japanese HBOC/CDx testing Average risk coverage for NIPS; improved reimbursement for expanded carrier screening Incremental reimbursement for mypath Melanoma, Prolaris, Vectra and EndoPredict 15

Almost ¼ of Women in OBGYN Practices Meet Guidelines Previous Market Estimates Likely Understate True Market Size 2,905 906 23.8% of women met NCCN criteria for hereditary cancer testing Met NCCN Criteria Did Not Meet NCCN Criteria Source: DeFrancesco et al. Hereditary Cancer Risk Assessment and Genetic Testing in Community Setting, Obstetrics & Gynecology 2018 16

Adding HOXB13 Gene to MyRisk Hereditary Cancer Panel Important Gene For Determining Hereditary Prostate Cancer Risk HOXB13 Clinical Implications: Men with a deleterious variant have up to a 52% lifetime risk of prostate cancer Clinical Recommendations: More frequent screening for prostate cancer HOXB13 17

Study Highlights Importance of Variant Reclassification Program Key Competitive Differentiator for Myriad s myrisk Hereditary Cancer Test 1.45 Million Patients Tested Over 10 Years 25% of VUS reclassified leading to 59,995 amended reports 9% Deleterious Variants Pheno MuCo 3D Structural Analysis LitVIEW insite Source: Mersch et al. Prevalence of Variant Reclassification Following Hereditary Cancer Genetic Testing, JAMA 2018 18

Optum Study Strengthens GeneSight Health Economic Data First Year Savings >$6,000 in Patients With Major Depressive Disorder GeneSight TAU Savings 13% All Psychiatry Patients $17,627 $23,132 $5,505 (p=0.0004) 37% Patients With MDD $18,741 $24,971 $6,050 (p=0.009) 50% Savings do not include productivity improvements Pharmacy Inpatient Services Outpatient Services & Professional Services 19

Robust Clinical Evidence Supporting GeneSight GUIDED Study Provides Level One Evidence Supporting Clinical Utility Outcome Measures at Week 8 Remission (HAMD-17) p=0.007 50% improvement in remission Response (HAMD-17) p=0.013 30% improvement in response Symptom Improvement (HAMD-17) p=0.107 14% improvement in symptoms 0 5 10 15 20 25 30 Percentage GeneSight TAU n=560 n=607 20

Patients Switching From Red Medications Highly Statistically Significant Improvement in All Endpoints Remission Response Symptom Improvement Baseline Week 8 Baseline Week 8 Switch No Switch Switch No Switch Switch No Switch Compares 57% of patients that switched vs. 43% of patients that did not 21

Significant Opportunity for Revenue Synergies Combined Sales Teams Will Triple Physician Reach in Women s Health 37,000 OBGYNs in Clinical Practice 9,000 Unique Ordering Physicians 23,000 OBGYNs Not Targeted 16,000 Women s Health Call 1,500 Overlap Physicians Points 3,500 Unique Ordering Physicians Myriad Oderers Overlap Counsyl Orderers Not Targeted 22

Reimbursement Catalysts for Foresight and Prelude New Coverage Decisions and Medical Policy Changes Could Increase ASP Medicare announces preliminary pricing for CPT code 81412 at $2,448 New clinical utility study published in Genetics in Medicine will help with guideline changes Evidence Street announces positive recommendation on average risk testing Two BCBS plans update medical policies to cover average risk Anticipate ACOG guidelines for average risk women 23

Vectra Study on Minimally Important Difference Important for Establishing Medical Management Tool on Test Report 24

Medicare Issues Favorable Draft LCD for mypath Melanoma Creates Opportunity for mypath Melanoma Revenue in FY20 U.S. mypath Melanoma Insurance Coverage (31%)* 300,000 indeterminate skin biopsies in the U.S. every year = $450M market 225 80 Sales Reps Sales Reps Commercial Insurers Medicare 7 commercial insurers cover the test Medicare Private Covered Private Non-Covered *Assumes favorable coverage decision from Medicare in FY19 25

AAD Issues Positive Guidelines for mypath Melanoma Important Step to Establish Broad Reimbursement Coverage mypath Melanoma is the only gene expression profiling test cited in the guidelines *Swetter et al Journal of the American Academy of Dermatology, October 2018 26

Worldwide Leader in Personalized Medicine We are entering the golden age for personalized medicine Molecular diagnostics are the keystone for improving patient outcomes while eliminating waste in healthcare spending Myriad is the pioneer of research-based and education-centric business model for molecular diagnostics We are the best positioned company to lead this revolution in healthcare Copyright 2017 2018 Myriad Myriad Genetics, Inc., Inc., all all rights rights reserved. 27 www.myriad.com.