On February 5, 2019 Myriad Genetics, Inc. (NASDAQ: MYGN, "Myriad" or the "Company"), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal second-quarter 2019, provided an update on recent business highlights, maintained its fiscal year 2019 financial guidance and provided fiscal third-quarter 2019 financial guidance (Press release, Myriad Genetics, FEB 5, 2019, View Source [SID1234533067]).

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"This quarter we saw a return to revenue growth for our hereditary cancer business, an acceleration in our prenatal testing and continued profitability improvements driven by the Elevate 2020 program," said Mark C. Capone, president and CEO, Myriad Genetics. "Importantly, in the last month, we announced two pivotal events with the publication of the GeneSight GUIDED study and the launch of our expanded Women’s Health sales team, which have the potential to drive transformational growth and long-term shareholder value."

Business Highlights

Hereditary Cancer

Revenue returned to growth for the first time since fiscal year 2014.

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

Presented validation study on riskScore for women of Hispanic descent at the 2018 San Antonio Breast Cancer Symposium, consisting of almost 9,000 women analyzed with a proprietary test that was highly predictive of breast cancer risk (p= 7.1 x 10-19).

Submitted our application to the Japanese Ministry of Health, Labour, and Welfare, for BRACAnalysis in hereditary cancer patients. There are approximately 3 million women in Japan who will be candidates for this test if approved.

GeneSight

GeneSight test volume increased 22 percent year over year.

GeneSight revenue was negatively impacted by changes in Medicare documentation requirements and the impact on cash collections from recently implemented industry-wide laboratory benefit manager programs.

A record 16,000 physicians ordered a GeneSight test in the fiscal second quarter.

Published the landmark GUIDED study in the Journal of Psychiatric Research, which is the largest prospective pharmacogenomics study ever conducted in depression. The key finding of the study was that patients were 50 percent more likely to achieve remission and 30 percent more likely to respond to treatment when their medication selection was guided by the GeneSight test.

Prenatal Testing

Prenatal testing volume increased at a double-digit rate year-over-year with total revenue increasing 12 percent sequentially.

Completed sales force expansion in early January, tripling the number of sales representatives selling prenatal tests.

Launched Myriad Complete application which includes patient education, cost estimators, test results, electronic reporting, and counseling tools for physician and patient customers, covering all Myriad Women’s Health products including myRisk Hereditary Cancer.

Published a large clinical utility study for ForeSight in Genetics in Medicine. The study found that the ForeSight test led to significant changes in pregnancy management with 77 percent of at-risk couples taking steps to avoid having an affected offspring such as prenatal

diagnostic testing and in-vitro fertilization.

Vectra

Fiscal second-quarter revenue increased six percent year over year to $11.8 million.

Published study in Rheumatology demonstrating that Vectra was five times more predictive of radiographic progression compared to historical measures of disease activity.

Prolaris

Fiscal second-quarter revenue increased 45 percent year-over-year to $6.1 million.

EndoPredict

Fiscal second-quarter revenue increased 10 percent year-over-year to $2.2 million.

Received favorable National Comprehensive Cancer Network Guidelines.

Received a favorable recommendation from NICE in the United Kingdom providing reimbursement coverage for the test.

Presented data at the San Antonio Breast Cancer Symposium (SABCS) from a retrospective study with 3,746 women that evaluated the benefit of chemotherapy on 10-year distant recurrence in women with estrogen receptor positive, HER2 negative breast cancer. The study found that women with a high EndoPredict score who received chemotherapy saw a statistically significant benefit with lower rates of 10-year distant recurrence compared to high risk women who did not receive chemotherapy.

A second study presented at SABCS evaluated the distant recurrence rates in 1,702 women who received five years of endocrine therapy alone and were followed for 15 years. This study showed a four-fold risk of recurrence in the 5 to 15 year timeframe for women with a high EndoPredict score and demonstrates EndoPredict can identify women who will benefit from extended endocrine therapy.

A third, 373 patient study was presented at SABCS that is positioned to corroborate the ability of EndoPredict to predict chemotherapy benefit. This is the first prospective study to ever evaluate chemoprediction in a high-risk cohort for any breast cancer recurrence test. In a 3-year interim evaluation of the data, high-risk patients who received chemotherapy had a disease free recurrence rate of 96.3 percent compared to 91.5 percent in the high-risk patients who did not receive chemotherapy (p=0.06).

Companion Diagnostics

Received U.S. Food and Drug Administration approval for BRACAnalysis CDx for use in conjunction with olaparib for maintenance in first-line ovarian cancer.

Completed our submission in Japan for BRACAnalysis CDx as a companion diagnostic in first line ovarian cancer with olaparib.

Fiscal Year 2019 and Fiscal Third-Quarter 2019 Financial Guidance

Myriad’s fiscal year 2019 and third-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, February 5, 2019, at 4:30 p.m. EDT to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-888-222-6159. International callers may dial 1-303-223-4369. All callers will be asked to reference reservation number 21914704. 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.