- Total Revenues of $177.5 Million
- Adjusted EPS of $0.23 and Diluted EPS of ($0.02)
- Company Maintains Fiscal Year 2017 Financial Guidance and Issues Fiscal Second-Quarter 2017 Financial Guidance
- Below are tables summarizing the financial results and revenue by product class for our fiscal first-quarter 2017:
|($ in millions)||2017||2016||% Change|
|Molecular diagnostic testing revenue|
|Hereditary cancer testing revenue||$||139.3||$||156.7||(11||%)|
|GeneSight testing revenue||7.2*||0.0||NM|
|Vectra DA testing revenue||11.6||11.4||2||%|
|Prolaris testing revenue||2.9||0.7||314||%|
|EndoPredict testing revenue||1.7||0.8||113||%|
|Other testing revenue||2.4||2.3||4||%|
|Total molecular diagnostic testing revenue||165.1||171.9||(4||%)|
|Pharmaceutical and clinical service revenue||12.4||11.6||7||%|
|($ in millions)||2017||2016||% Change|
|Adjusted Operating Income||21.6||46.5||(54||%)|
|Adjusted Operating Margin||12.2||%||25.3||%|
|* represents revenue for the month of September only|
- myRisk ® Hereditary Cancer
- Signed preferred provider agreements with major physician networks in oncology representing approximately 70 percent of community oncologists in the country, or approximately 4,000 physicians.
- Launched a customizable myRisk panel for genetics experts who are interested in tailoring their gene selections.
- Ended the quarter with 65 percent of revenue under long-term contract and 95 percent of insurance plans in network.
- GeneSight ®
- Volumes were up 70 percent year-over-year to approximately 51,000 tests performed in the full fiscal first-quarter 2017.
- Reached 90 percent enrollment in a landmark 1,200 patient clinical utility study evaluating GeneSight in patients with depression or anxiety treated by preventive care physicians or psychiatrists.
- Vectra ® DA
- Volumes were up four percent year-over-year in the fiscal first-quarter with approximately 39,000 tests performed.
- Announced the presentation of four abstracts at the American College of Rheumatology conference in November, showing the ability of Vectra DA to predict which patients will experience flare or sustained remission, and the ability of the Vectra DA score to provide added predictive value to traditional measures of disease activity.
- Prolaris ®
- Volumes increased 56 percent year-over-year with approximately 4,400 tests ordered.
- Companion Diagnostics
- Announced data from the first prospective validation of myChoice HRD from the NOVA study, evaluating the PARP inhibitor, niraparib. In the study, which evaluated platinum-sensitive ovarian cancer patients, myChoice HRD positive patients demonstrated a 9.1 month median progression free survival benefit versus a 3.1 progression free survival benefit in myChoice HRD negative patients. Myriad has submitted the first module of its premarket approval application for myChoice HRD to the FDA.
- Announced data from the AstraZeneca SOLO2 study, which compared maintenance olaparib against placebo in patients with platinum-sensitive relapsed ovarian cancer met its primary endpoint. These results further validate that BRCA status as determined by BRACAnalysis CDx can identify patients likely to benefit from PARP inhibition therapy.
- Myriad signed an agreement with AstraZeneca to use its newest companion diagnostic, myChoice HRD Plus, to help prospectively identify patients for enrollment in an upcoming exploratory study involving olaparib. myChoice HRD Plus combines Myriad's proprietary myChoice HRD assay with 102 additional genes involved in DNA repair.
- Revenues were up 43 percent year-over-year in the first quarter and accounted for approximately five percent of total product revenue.
- EndoPredict revenues grew 113 percent year-over-year to $1.7 million in the first quarter of fiscal year 2017.
- Completed enrollment in an EndoPredict study evaluating the ability of the test to predict response to neoadjuvant chemotherapy. Results of the study are expected to be presented in calendar year 2017.
- In August, the German public reimbursement system (GBA) issued new ambulatory specialty care (ASV) reimbursement covering gene expression testing for breast cancer when conducted in authorized major centers throughout Germany.
- Share Repurchase
- During the quarter, the Company repurchased approximately 1.0 million shares, or $21 million, of common stock under our share repurchase program and ended the quarter with approximately $171 million remaining on our current share repurchase authorization.
|Revenue||Adjusted Earnings Per Share||GAAP Diluted Earnings Per Share|
|Fiscal Year 2017||$740-$760 million||$1.00-$1.10||$0.34-$0.44|
|Fiscal Second-Quarter 2017||$188-$190 million||$0.23-$0.25||$0.06-$0.08|