SALT LAKE CITY, UT USA (Press Release) - October 17, 2014 -
Company Pre-Releases First Quarter Revenue and EPS; Confirms FY15 Guidance
Myriad Genetics, Inc. today announced that Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, has issued a draft local coverage determination (LCD) for Prolaris, Myriad’s revolutionary prostate cancer test.
The LCD is posted to the Medicare Coverage Database on the Centers for Medicare & Medicaid Services (CMS) website and establishes the coverage policy for Medicare beneficiaries. The current language in the draft LCD provides reimbursement coverage for the approximately 50% of prostate cancer patients defined as low and very low risk. Under Medicare rules, the draft LCD is subject to a minimum 45-day public comment period. After comments are considered, a final LCD is issued, which goes into effect after a minimum 45-day notification period.
"We are very excited by this draft coverage determination as a first step in ensuring that all Medicare prostate cancer patients will have access to Prolaris testing which we believe provides the highest quality and most accurate assessment of their cancer’s aggressiveness," said Pete Meldrum, president and CEO of Myriad. "Prolaris is the only test that can use the initial biopsy to accurately predict cancer-specific death in men with prostate cancer. In multiple clinical validation studies, Prolaris has been shown to be a much stronger indicator of clinical outcomes than adverse pathology for patients across all risk categories."
National Launch of Myriad myRisk™ Hereditary Cancer Test; Impact on Fiscal First Quarter Financial Results
Myriad also announced today that the Company has initiated a national launch for its myRisk Hereditary Cancer test and sample volumes have rapidly increased, exceeding Company expectations. myRisk sample volumes now represent more than 50 percent of all hereditary cancer samples received by Myriad. With a more rapid transition to myRisk and higher than anticipated physician demand, the Company experienced an increase in costs to perform the test and an increase in turnaround time during the first fiscal quarter ended September 30, 2014. This increased turnaround time translated into increased work-in-progress, or WIP, and a corresponding decrease in revenue that was not anticipated when Myriad issued its fiscal year 2015 financial guidance in August 2014. The Company now estimates first quarter revenue to be approximately $168 million and adjusted earnings per share to be approximately $0.25 (GAAP earnings per share of $0.21). These estimates are based upon the Company’s current projections and are subject to change.
The Company is responding to address its customers’ needs and is hiring additional staff, as well as purchasing more equipment to meet this increased demand for myRisk testing. Myriad believes capacity will increase throughout the second fiscal quarter, and that it will be able to reduce turnaround times beginning in the second half of fiscal year 2015.
While first quarter revenue was negatively impacted by turnaround times, given the underlying strength of the business, the Company is reaffirming its financial guidance for the 2015 fiscal year of total revenues of $800 to $820 million and adjusted, fully diluted earnings per share of $1.90 to $2.00 (GAAP earnings per share of $1.75 to $1.85).
“We are very pleased with the high level of physician interest in myRisk, and we are working hard to meet this demand,” said Meldrum. “We believe that our rapid conversion of the hereditary cancer market to gene panel testing, and the investments we have made in our new product pipeline, position Myriad exceptionally well for the future.”
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly measures tumor cell growth characteristics for stratifying the risk of disease progression in prostate cancer patients. Prolaris provides a quantitative measure of the RNA expression levels of genes involved in the progression of tumor growth. Low gene expression is associated with a low risk of disease progression in men who may be candidates for active surveillance and high gene expression is associated with a higher risk of disease progression in patients who may benefit from additional therapy. Prolaris has been proven to predict prostate cancer-specific disease progression in 11 clinical trials with more than 6,000 patients. For more information visit: www.prolaris.com.
About Myriad myRisk™ Hereditary Cancer Testing
The Myriad myRisk Hereditary Cancer test uses next-generation sequencing technology to evaluate 25 clinically significant genes associated with eight hereditary cancer sites including: breast, colon, ovarian, endometrial, pancreatic, prostate and gastric cancers and melanoma. For more information visit: www.myriad.com/products-services/hereditary-cancers/myrisk-hereditary-cancer/.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: www.myriad.com.
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