On November 3, 2015 Myriad Genetics, Inc. (NASDAQ:MYGN) reported financial results for its fiscal first-quarter 2016, provided an update on recent business highlights, maintained its fiscal year 2016 financial guidance and provided fiscal second-quarter 2016 financial guidance (Press release, Myriad Genetics, NOV 3, 2015, View Source [SID:1234507930]).
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"We were very pleased with our results in the first quarter and reiterate our fiscal 2016 guidance," said Mark C. Capone, president and chief executive officer of Myriad. "More importantly, we continued the excellent progress on our five-year plan to transform Myriad into a diversified global pioneer in personalized medicine. We are now beginning to see the benefits of the substantial investments the Company has made in our industry-leading pipeline and international expansion, which we believe will drive significant shareholder value over the next five years."
Financial Highlights
The Company exited the quarter with approximately 80 percent of incoming hereditary cancer tests being ordered as myRisk, representing 100 percent conversion of our targeted physician base.
The increase in adjusted operating income and net income on a year-over-year basis was driven by higher revenue, improved operational efficiencies in our myRisk Hereditary Cancer laboratory, lower research and development expense and leverage in sales, general and administrative expenses.
During the quarter, the Company repurchased approximately 1.1 million shares, or $38 million, of common stock under our share repurchase program and ended the quarter with approximately $117 million remaining on our current share repurchase authorization. Fiscal first-quarter diluted weighted average shares outstanding were 72.1 million compared to 76.1 million in the same period last year.
Business Highlights
At the upcoming American College of Rheumatology annual meeting Myriad will present several studies showing the potential for Vectra DA to predict treatment response in patients with rheumatoid arthritis. The studies demonstrated that the Vectra DA score was predictive of response to either triple therapy or anti-TNF therapy, predicted flare in patients discontinuing anti-TNF therapy and could predict relapse in patients undergoing tapering for disease modifying anti-rheumatic drugs.
In August, Myriad received a favorable final local coverage determination for its Prolaris test from Noridian, the Medicare Administrative Contractor for the Company. The coverage determination, which became effective October 15, 2015, covers Prolaris for patients defined as low or very-low risk by the National Comprehensive Cancer Network guidelines.
Tufts Health Plan and Myriad signed a three-year contract that will cover Prolaris for all members diagnosed with localized prostate cancer across all risk categories.
Myriad presented data at the recent American Society for Dermatopathology Annual Meeting that demonstrated the ability of myPath Melanoma to accurately predict cancer outcomes by evaluating 127 patients with melanocytic lesions. Of the 65 lesions that were classified as melanomas by pathologists, myPath Melanoma results agreed with 61 of these classifications representing a sensitivity of 97 percent. Importantly, myPath Melanoma identified 100 percent of the 14 lesions which went on to become metastatic melanoma.
At the International Association for the Study of Lung Cancer, Myriad presented data that compared the myPlan Lung Cancer score to standard pathological risk factors. Of the 183 patients that were designated as high-risk by the myPlan Lung Cancer test, less than 50 percent had three or more high-risk features and would have been designated as low-risk utilizing standard pathology.
At the European Society for Clinical Oncology Meeting, Myriad presented new data on its myChoice HRD test from the NOVA study currently being conducted by TESARO, one of Myriad’s pharmaceutical collaborators. The data showed that 100 percent of patients with a BRCA mutation and 55 percent of patients without a BRCA mutation were HRD positive and would have been missed with tumor sequencing alone. Additionally, the myChoice HRD algorithm which utilizes three proprietary technologies (LOH, TAI, and LST) better defined the HRD positive population than LOH alone.