On August 11, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal fourth-quarter and fiscal full year ended June 30, 2015, provided an update on recent business highlights and provided fiscal year 2016 and fiscal first-quarter 2016 financial guidance (Press release, Myriad Genetics, AUG 11, 2015, View Source [SID:1234507203]).
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"We delivered sequential growth in the fourth quarter and made significant progress towards completing the conversion of our targeted physician base to myRisk Hereditary Cancer testing," said Mark C. Capone, president and chief executive officer of Myriad. "As we look forward to fiscal year 2016, we are confident that we are poised to generate top- and bottom-line growth beginning a trend that reflects increased investments in our product pipeline and international expansion. Over the next several years, we expect that these investments will drive revenue growth and operating leverage as we look to transform Myriad into a worldwide personalized medicine company."
Financial Highlights
myRisk Hereditary Cancer testing revenue increased to $100.9 million in the fourth quarter of fiscal 2015 from $27.3 million in the fourth quarter of the prior year, and the Company exited the quarter with 72 percent of incoming hereditary cancer samples ordered as myRisk.
The decline in both adjusted operating and net income in the fiscal fourth quarter 2015 relative to the prior year is attributable to lower gross margins associated with the transition costs of myRisk Hereditary Cancer testing and incremental product launch expenses for Prolaris, myPath Melanoma and myPlan Lung Cancer tests.
During the quarter, the Company repurchased approximately 1.3 million shares, or $45 million, of common stock under its share repurchase program and ended the quarter with approximately $155 million remaining on its current share repurchase authorization. Fiscal fourth-quarter diluted weighted average shares outstanding were 72.4 million compared to 77.7 million in the same period last year.
Business Highlights
Myriad presented data on 19 abstracts at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) including:
Results from the Geparsixto study that showed the ability of the myChoice HRD test to predict response to carboplatin containing chemotherapy in 193 patients with triple negative breast cancer. The highest response rate of 64 percent was seen in patients with a positive HRD score who received both carboplatin and standard of care chemotherapy, compared to 30 percent in patients with a negative HRD score.
Data demonstrating the ability of myChoice HRD to identify responders to Tesaro’s novel therapeutic drug candidate niraparib. In a study of 106 patients with advanced ovarian cancer, myChoice HRD identified 100 percent of responders to the investigational drug.
A study of almost 77,000 patients tested with myRisk Hereditary Cancer demonstrated that the detection rate for mutations increased 130 percent relative to BRCA1/BRCA2 testing alone. We also presented a study on endometrial cancer demonstrating that over 9 percent of patients carried a deleterious mutation in one of the myRisk genes, which we believe justifies broad testing for this population consistent with recent National Comprehensive Cancer Network (NCCN) recommendations.
Vectra DA volumes increased to a new record in the fiscal fourth quarter, growing 12 percent sequentially to just under 40,000 tests ordered with revenue up 12 percent sequentially to $11.8 million.
Presented data at the America Urological Association (AUA) meeting including:
Key data defining an active surveillance threshold for our Prolaris test. The active surveillance threshold sets a defined cutoff for patients and has been clinically validated to show patients with scores below the cutoff have a 10-year prostate cancer specific mortality of less than 3 percent.
The final results of the PROCEDE 1,000 clinical utility study that evaluated the impact of the Prolaris score on treatment recommendations for 1,206 prostate cancer patients. The final data showed that physicians had a 48 percent change in treatment recommendations in which 35 percent of patients saw a reduction in therapy and 13 percent saw an increase in therapy.
Fiscal First-Quarter and Fiscal Full Year 2016 Financial Guidance
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 it is holding today to discuss its fiscal fourth quarter and full year 2015 financial results and fiscal year 2016 financial guidance.