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Myriad Genetics Reports Financial Results For Second Quarter Of Fiscal Year 2014

SALT LAKE CITY, Feb. 4, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced financial results for its fiscal second quarter and six months ended December 31, 2013. Revenue for the second quarter was $204.1 million, a 37 percent increase over the same period in the prior year. Second quarter earnings per diluted share (EPS) were $0.66, an increase of 57 percent compared to the second quarter of 2013.

"I am extremely proud of the Myriad team as this quarter represents the tenth consecutive quarter where our revenue growth has exceeded 20 percent," said Peter D. Meldrum, president and CEO of Myriad. "Looking ahead, we plan to continue to execute upon our strategic plan of transitioning our hereditary cancer market, expanding our business internationally, and diversifying our revenue base with new product launches."

Fiscal Second Quarter 2014 Results

  • Molecular diagnostic testing revenue in the second quarter rose to $196.2 million, an increase of 39 percent compared to the second quarter of 2013. We believe that our increased sales, marketing, and education efforts resulted in wider acceptance of our molecular diagnostic tests by the medical community and increased patient testing volumes. Revenue from the Oncology segment was $101.6 million, an increase of 12 percent compared to the second quarter of 2013. Women's Health revenue totaled $94.6 million, an increase of 90 percent from the same period in the prior year.
  • Revenue from the BRAC Analysis ® test was $141.2 million, a 28 percent increase over the prior year period, and represented 69 percent of total revenue in the second quarter.
  • Revenue from the BART™ test was $24.7 million, a 57 percent increase over the same period a year ago, and represented 12 percent of total revenue.
  • Revenue from the COLARIS ® and COLARIS AP ® tests was $15.6 million, an increase of 29 percent compared to the second quarter of 2013, and represented 8 percent of total revenue.
  • Revenue from the Myriad myRisk TM Hereditary Cancer test, which launched on September 3, 2013, was $11.5 million in the second quarter, representing 6 percent of total revenue. 
  • Revenue from Myriad's other molecular diagnostic tests was $3.2 million, an increase of 25 percent compared to the previous year, and represented approximately 1 percent of total revenue.
  • Companion diagnostic service revenue in the fiscal second quarter was $7.9 million, a 7 percent decrease over the same period in 2013. Companion diagnostic revenue represented 4 percent of total revenue.
  • Operating income in the second fiscal quarter improved to $83.0 million, an increase of 49 percent compared to the second quarter of 2013. Operating margins in the fiscal second quarter were 40.7 percent compared to 37.3 percent in the prior year period. The improvement in operating margins was driven primarily by operational leverage in SG&A and R&D expenses.
  • Net income for the fiscal second quarter was $50.4 million, an increase of 44 percent compared to the same period in 2013.  
  • During the quarter, the Company repurchased 3.2 million shares or $77.8 million of common stock under its stock repurchase program. Fiscal second quarter diluted weighted average shares outstanding were 76.8 million compared to 84.2 million in the same period last year. 
  • The Company ended the quarter with $488.8 million in cash, cash equivalents and marketable investment securities compared to $468.3 million at December 31, 2012, representing a 4 percent increase year-over-year.

Year-to-Date Performance

  • Total revenue for the first half of fiscal 2014 was $406.5 million, an increase of 44 percent over the $282.6 million reported for the first half of fiscal 2013.
  • Operating income for the first half of fiscal 2014 was $165.9 million, an increase of 59 percent over the $104.2 million reported for the same period of the prior year.
  • Net income for the first half of fiscal 2014 was $105.8 million, an increase of 62 percent over the $65.2 million in the first half of the prior year.
  • In the first half of fiscal 2014, diluted earnings per share increased 72 percent to $1.33 compared to $0.78 for the same period in the prior year.

Business Highlights

  • Myriad launched the Myriad myPlan™ Lung Cancer test in October 2013 to assist physicians in determining a newly diagnosed patient's risk of dying from lung cancer within five years. We believe that this information can assist a physician decide whether an early stage patient should receive surgery alone or surgery plus adjuvant chemotherapy or radiation therapy.
  • In November 2013, Myriad launched the Myriad myPath™ Melanoma test to leading dermatopathologists throughout the United States. The test was validated in a 464 patient clinical study where it demonstrated over 90 percent accuracy in differentiating malignant melanoma from benign skin lesions. Myriad myPath Melanoma is the only test on the market that can accurately diagnose all four major melanoma subtypes.
  • Myriad presented data at the San Antonio Breast Cancer Symposium demonstrating that the Myriad myRisk Hereditary Cancer test detected 52 percent more patients with a high risk for hereditary breast and ovarian cancer than was found by testing for the BRCA1 and BRCA2 genes alone. Additionally, Myriad presented data demonstrating that the Myriad myRisk test detected 60 percent more patients with a high predisposition risk of hereditary colon and endometrial cancer than was found by testing the major colon cancer genes alone. The Myriad myRisk Hereditary Cancer test has unparalleled accuracy of 99.98 percent.
  • Myriad's Investigational Device Exemption (IDE) for BRACAnalysis testing was accepted by the U.S. Food and Drug Administration (FDA) for use in AstraZeneca's Phase 3 clinical trials for olaparib and for use in BioMarin's Phase 3 clinical trial for BMN-673.
  • Myriad announced a new research collaboration with Janssen to use Myriad's BRACAnalysis test in Janssen's Phase 3 clinical trial with Yondelis (tabectedin) in the treatment of advanced-relapsed epithelial ovarian, primary peritoneal, or fallopian tube cancers.
  • Myriad signed a research collaboration with BioMarin in the fiscal second quarter to use Myriad's HRD test to identify tumor types that may be sensitive to BioMarin's investigational new drug, BMN-673. This represents Myriad's second publicly announced research collaboration with the Company's HRD test.
  • Myriad presented data at the San Antonio Breast Cancer Symposium showing that its HRD test was highly predictive of cisplatin response in patients with triple-negative breast cancer. This is the second study validating the HRD test in successfully predicting platinum response in triple-negative breast cancer patients.
  • Myriad presented data at the Annual Meeting of the Society for Urologic Oncology (SUO) from four clinical studies with Prolaris testing demonstrating its ability to accurately predict the aggressiveness of a man's prostate cancer. Prolaris testing has now been studied in 11 clinical trials involving over 5,000 patients.
  • Myriad presented interim data from its PROCEDE 500 study at the ASCO GU Cancer Symposium showing that physicians changed their intended therapy and selected a different treatment based on the Prolaris test score in 65 percent of their cases. In 40 percent of patients, physicians reduced the therapeutic burden on the patients and opted for active surveillance in lieu of surgery or radiation therapy. In 25 percent of patients, physicians opted for more aggressive therapies.

Increased Fiscal Year 2014 Outlook

Based on the growth in its core markets and the acquisition of Crescendo Bioscience announced today, Myriad is raising its revenue expectations for fiscal year ending June 30, 2014. The Company is now forecasting revenues of $740 to $750 million, compared to previous guidance of $700 to $715 million. This new guidance represents 21 to 22 percent revenue growth when compared to the prior fiscal year and incorporates the Company's projection for approximately $10 million in revenue from the Crescendo acquisition, the completion of which is subject to regulatory clearance and satisfaction of customary closing conditions. 

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