On August 13, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and precision medicine, reported financial results for its fiscal fourth-quarter and full-year 2019, reported an update on recent business highlights and provided fiscal year and first-quarter 2020 financial guidance (Press release, Myriad Genetics, AUG 13, 2019, View Source [SID1234538763]).

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"Fiscal year 2019 revenue increased 14 percent with earnings up 18 percent. Unfortunately, revenue in the fourth quarter was two percent below expectations largely due to lower reimbursement for our expanded carrier screening test," said Mark C. Capone, president and CEO, Myriad Genetics. "Looking ahead to fiscal year 2020, with stabilized pricing, growing new product volumes and recent reimbursement advances with GeneSight, we are highly optimistic about our ability to deliver an inflection in revenue and earnings as we transition through the fiscal year."

Recent Business Highlights

Hereditary Cancer

Hereditary cancer revenue returned to year-over-year growth in fiscal year 2019 representing the first time hereditary cancer revenue has grown in the last five fiscal years.

Presented data at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting from the Women’s Health Initiative study that evaluated mutation rates in 2,195 post-menopausal women with breast cancer. The study found that women with post-menopausal breast cancer had a high rate of inherited mutations in a range of cancer causing genes and this mutation rate did not diminish with age. This along with other studies have shown that

current hereditary breast cancer testing guidelines miss approximately 50 percent of mutation carriers.

GeneSight

Announced coverage decision from UnitedHealth, the largest commercial payer in the United States, covering GeneSight for patients that have a diagnosis of major depressive disorder or anxiety and have failed at least one prior medication.

Announced coverage decision for GeneSight by Kroger Prescription Plans. As part of the agreement, Kroger initiated an early access program at 500 Kroger pharmacies where GeneSight testing will be facilitated by the Kroger Health pharmacist.

Presented data at the Clinical Pharmacogenomics Implementation Consortium annual meeting showing GeneSight had more than double the predictive power for drug blood levels compared to single gene pharmacogenomics tests.

Completed a Medicare Coverage Advisory Committee meeting reviewing potential expansion of the GeneSight LCD to primary care physicians. During the meeting, Medicare’s selected subject matter experts unanimously agreed that pharmacogenomics testing should be available to primary care physicians.

Prolaris

Published data from a large study of 1,062 men with newly diagnosed localized prostate cancer to evaluate the ability of the Prolaris test to predict risk of metastases. The study found that Prolaris was the strongest independent predictor of progression to metastatic disease, and men were approximately three times more likely to develop metastatic disease with each unit increase in the Prolaris test score (HR: 2.93; p=1.8×10-11).

EndoPredict

Published data in the journal Clinical Cancer Research demonstrating that the EndoPredict test identifies women with early-stage breast cancer who can safely forgo extended endocrine therapy five years after diagnosis.

Published the results of the first comprehensive cost-effectiveness analysis of the EndoPredict test compared to other breast cancer assays. The study found that the EndoPredict test was more than twice as cost effective as Oncotype DX.

Companion Diagnostics

Announced that the BRACAnalysis CDx companion diagnostic test effectively identified patients with metastatic pancreatic cancer who benefitted from treatment with Lynparza

(olaparib) in the Phase III POLO study. Patients in the study with a germline mutation had a clinically-meaningful and statistically-significant improvement in progression-free survival (PFS) of 7.4 months when treated with Lynparza compared to 3.8 months for placebo (HR 0.53; p=0.004).

Received approval from the Japanese Ministry of Health, Labour, and Welfare for Myriad’s BRACAnalysis Diagnostic System as a companion for Lynparza in women with ovarian cancer.

Announced that BRACAnalysis CDx effectively identified patients with castrate resistant, metastatic prostate cancer who benefitted from treatment with Lynparza in the PROfound study. Results from the study showed a statistically-significant and clinically-meaningful improvement in radiographic progression-free survival in patients who received Lynparza vs. enzalutamide or abiraterone and had deleterious mutations in the BRCA1/2 genes.

myPath Melanoma

Received a positive final local coverage decision from Noridian Healthcare Solutions for myPath Melanoma.

German Clinic Sale

Announced planned sale of the Privatklinik Dr. Robert Schindlbeck GmbH & Co. KG (the "Clinic"), which is expected to occur around the middle of fiscal year 2020.

Fiscal Year 2020 and Fiscal First-Quarter 2020 Financial Guidance

Myriad’s fiscal year 2020 and first-quarter 2020 adjusted earnings per share guidance excludes the impact of stock based compensation expense, non-cash amortization associated with acquisitions and certain non-recurring expenses. These projections are forward-looking statements and are subject to the risks summarized in the safe harbor statement at the end of this press release. The company will provide further details on its business outlook during the conference call today and discuss the fiscal fourth-quarter financial results and fiscal year 2020 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, August 13, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal fourth-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-763-5615. International callers may dial 1-212-231-2936. All callers will be asked to reference reservation number 21927089. An archived replay of the call will be available for seven days by dialing (800) 633-8284 and entering the reservation number above. The conference call along with a slide presentation will also will be available through a live webcast at www.myriad.com.