On February 6, 2018 Myriad Genetics, Inc. (NASDAQ:MYGN), a global leader in molecular diagnostics and personalized medicine, reported financial results for its fiscal second-quarter 2018, provided an update on recent business highlights, raised its fiscal year 2018 financial guidance, and issued fiscal third-quarter 2018 financial guidance (Press release, Myriad Genetics, FEB 6, 2018, View Source [SID1234523763]).

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"We exceeded our financial expectations in the first half of fiscal year 2018 as a result of strong hereditary cancer volume trends, solid GeneSight revenue growth, and significant progress on our Elevate 2020 profitability program," said Mark C. Capone, president and CEO, Myriad Genetics. "Based upon this strong performance we are increasing our financial guidance for fiscal 2018. We remain highly encouraged that our strategy to build upon the solid foundation of our hereditary cancer business with diversified revenues from our industry-leading pipeline of new products will deliver significant future revenue and earnings growth."

Business Highlights

• Hereditary Cancer

Achieved the fourth consecutive quarter of year-over-year volume growth and again exceeded our three percent fiscal 2018 volume growth target.
Presented pivotal validation data for riskScore at the San Antonio Breast Cancer Symposium (SABCS) with data from over 1,617 women. The results show that riskScore is a highly statistically significant predictor of the 5-year and lifetime risk of breast cancer (p=5.2×10-39 and p=4.1×10-35, respectively).
Successful commercial launch of riskScore led to an acceleration in preventive care hereditary cancer test volumes.
• GeneSight

Announced data from 1,200 patient prospective randomized controlled trial showing GeneSight led to a highly statistically significant improvement in the gold-standard outcomes of response and remission (p<0.01 and p=0.01 respectively).
GeneSight revenue increased 46 percent year-over-year with double-digit, sequential volume growth.
Announced top-line data from 2,000 patient IMPACT study demonstrating that with GeneSight primary care physicians saw even better outcomes when compared to psychiatrists.
Announced the PRIME Care study in conjunction with the Department of Veterans Affairs, which will be a randomized controlled trial enrolling over 2,000 patients with major depressive disorder at 21 VA medical centers. The Department of Veterans Affairs has committed over $12 million to fund the study, which will evaluate how the GeneSight test influences the key endpoints of remission, response, and symptom improvement relative to patients receiving standard of care therapy.
• Vectra DA

Presented data at the American College of Rheumatology (ACR) meeting demonstrating that Vectra DA was more than three times better at predicting radiographic progression compared to conventional measures of disease activity.
Presented new clinical utility data from 60,596 patients demonstrating that physicians use Vectra DA scores to change treatment decisions appropriately. The study found that in patients who were naive to biologics, rheumatologists were 118 percent more likely to recommend a biologic for patients with a high Vectra DA score when compared to patients with a low Vectra DA score. For patients already on a biologic, rheumatologists were 158 percent more likely to change therapy for those with high Vectra DA scores compared to those with low Vectra DA scores.
Submitted a new publication on Vectra DA showing the change in Vectra DA scores required to recommend a modification in treatment. This clinical utility data will be utilized to add a medical management protocol to the Vectra DA test report.
Published clinical utility study for a new indication in the Annals of Rheumatic Diseases demonstrating that in over 70,000 Medicare patients there was a strong link between Vectra DA score and cardiovascular disease.
• Prolaris

Finalized Medicare Local Coverage Decision (LCD) for favorable intermediate prostate cancer patients.
Prolaris volumes grew in the double-digits on a year-over-year basis.
• EndoPredict

United States test volumes increased over 70 percent on a sequential basis.
Presented chemopredictive data at SABCS demonstrating the ability of EndoPredict to predict response to neoadjuvant therapy in 217 women with HR+ breast cancer. The study found that patients with a low EndoPredict score were significantly more responsive to endocrine therapy (p=0.015) and women with a high EndoPredict score were significantly more responsive to neoadjuvant chemotherapy (p=0.0001).
• Companion Diagnostics

Received FDA approval for BRACAnalysis CDx as a companion diagnostic in conjunction with AstraZeneca’s Lynparza (olaparib) for HER2- metastatic breast cancer.
Pfizer presented positive data from the phase 3 EMBRACA trial in metastatic breast cancer using talazoparib, Pfizer’s investigational PARP inhibitor and Myriad’s BRACAnalysis CDx test as a companion diagnostic. Myriad plans to submit a supplementary premarket approval application to the U.S. Food and Drug Administration under its existing PMA for BRACAnalysis CDx to include talazoparib.
Announced an expanded research agreement with AstraZeneca using the company’s myChoice HRD Plus test in an exploratory analysis to identify women with advanced ovarian cancer who may benefit from maintenance treatment with Lynparza (olaparib) and Avastin (bevacizumab).
• Impact of Tax Reform

The company estimates that the tax reform legislation will positively benefit our fiscal 2018 full year adjusted earnings per share by approximately $0.06 with $0.02 recorded in the fiscal second quarter, and the remaining $0.04 benefit anticipated across the second half of fiscal year 2018.

Conference Call and Webcast

A conference call will be held today, Tuesday, February 6, 2018, at 4:30 p.m. ET to discuss Myriad’s financial results for the fiscal second-quarter, business developments and financial guidance. The dial-in number for domestic callers is 1-800-699-0623. International callers may dial 1-303-223-4362. All callers will be asked to reference reservation number 21879835. 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.