On May 7, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in personalized medicine, reported financial results for its fiscal third-quarter 2019, provided an update on recent business highlights, updated its fiscal year 2019 financial guidance, and provided fiscal fourth-quarter 2019 financial guidance (Press release, Myriad Genetics, MAY 7, 2019, View Source [SID1234535889]).

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"During the fiscal third-quarter we once again saw meaningful year-over-year growth in our hereditary cancer business, continued strong volume trends with our prenatal and GeneSight tests and posted one of the most profitable quarters in the history of the company," said Mark C. Capone, president and CEO, Myriad Genetics. "We continue to advance our diversification efforts with new products representing more than 76 percent of overall volume. With ongoing volume growth and expanding reimbursement, we remain highly optimistic about our future growth prospects."

Business Highlights

Hereditary Cancer

Year-over-year revenue growth reached four percent, the highest in the last five fiscal years.

Achieved ninth consecutive quarter of year-over-year hereditary cancer testing volume growth and sixth consecutive quarter with stable hereditary cancer pricing.

The American Society of Breast Surgeons expanded hereditary cancer testing guidelines to all breast cancer patients.

Data presented at the American College of Obstetrics and Gynecology meeting from a

large clinical study showed that 23 percent of women met National Comprehensive Cancer Network Guidelines for hereditary cancer screening, substantially higher than previously estimated.

GeneSight

Test volume increased 19 percent year over year.

Signed agreement with Kroger Prescription Plans to cover GeneSight as a medical benefit for Kroger Prescription Plans employer group clients and to launch a pharmacy medical management intervention in Kroger stores.

Prenatal Testing

Test volume grew seven percent sequentially following the integration of the Counsyl and Myriad women’s health sales teams.

Announced in-network agreement with UnitedHealthcare effective April 1, 2019.

Launched expanded aneuploidy screening for Prequel non-invasive prenatal screening test for all 23 chromosome pairs increasing sensitivity by 30 percent.

Presented data at the American College of Medical Genetics meeting from a 58,000 patient study demonstrating that the Prequel test was highly accurate below a four percent fetal fraction cutoff and that the inclusion of a cutoff did not improve test accuracy.

Published an expanded carrier screening study in Genetics in Medicine, demonstrating that 38 genes in the Foresight test met all panel inclusion criteria commonly recommended in medical guidelines.

Prolaris

Fiscal third-quarter revenue increased eight percent year-over-year to $6.9 million.

Received positive medical policy decisions from Blue Cross Blue Shield of Kansas, SmartHealth, Blue Cross Blue Shield of Northeastern New York, and Blue Cross Blue Shield of Western New York, thereby increasing coverage to 27 million commercial lives in the United States.

EndoPredict

Fiscal third-quarter revenue increased 22 percent year-over-year to $2.8 million.

New publication in Breast Cancer Research and Treatment found that the EndoPredict test accurately predicts the magnitude of chemotherapy benefit in women with ER-positive, HER2-negative breast cancer.

Companion Diagnostics

Submitted the first module of premarket approval application (PMA) for myChoice HRD CDx as a companion diagnostic for GlaxoSmithKline’s PARP inhibitor, niraparib, in ovarian cancer patients.

Announced new data showing BRACAnalysis CDx successfully identified patients with pancreatic cancer who benefitted from olaparib in AstraZeneca’s POLO study. Myriad intends to file a supplementary PMA to the U.S. Food and Drug Administration for BRACAnalysis CDx as a companion diagnostic for olaparib in patients with pancreatic cancer.

Expanded research collaboration with Merck and AstraZeneca to provide BRACAnalysis CDx testing for patients with metastatic castrate resistant prostate cancer.

Received approval from the Japanese Ministry of Health Labour and Welfare for BRACAnalysis CDx as a companion diagnostic for olaparib in first-line ovarian cancer patients.

myPath Melanoma

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

Fiscal Year 2019 and Fiscal Fourth-Quarter 2019 Financial Guidance

Below is a table summarizing Myriad’s fiscal year 2019 and fiscal fourth-quarter 2019 financial guidance:

Myriad’s fiscal year 2019 and fourth-quarter 2019 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 second-quarter financial results and fiscal year 2019 financial guidance.

Conference Call and Webcast

A conference call will be held today, Tuesday, May 7, 2019, at 4:30 p.m. EDT to discuss

Myriad’s financial results for the fiscal third-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-908-1487. International callers may dial 1-303-223-0120. All callers will be asked to reference reservation number 21920022. 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.