Myriad Genetics Reports Full-Year and Fiscal Fourth-Quarter 2013 Financial Results
"Myriad had an exceptional fourth quarter and delivered strong financial results in fiscal 2013 by successfully growing our existing businesses, and I am proud of the entire Myriad team," said
Fiscal Fourth Quarter 2013 Results
Molecular diagnostic testing revenue in the fiscal fourth quarter equaled
$166.1 million, an increase of 30 percent compared to the fourth quarter of 2012. Revenue from the Oncology segment equaled $100.2 million, an increase of 19 percent over the same period in 2012. Women's Healthrevenue totaled $65.8 million, an increase of 51 percent over the same period in the prior year.
- Revenue from the BRACAnalysis® test, which represented 74 percent of total revenue in the fourth quarter, was
$129.6 million, a 19 percent increase compared to fiscal year 2012.
- Revenue from the BART™ test was
$18.8 million, a 310 percent increase over the same period of the prior year, and represented 11 percent of total revenue.
- Revenue from the COLARIS® and COLARIS AP® tests were
$14.5 million, an increase of 26 percent compared to the fiscal fourth quarter of 2012, and represented 8 percent of total revenue.
- Revenue from Myriad's other molecular diagnostic tests were
$3.1 million, an increase of 16 percent compared to the prior year, and represented approximately 2 percent of total revenue.
Companion diagnostic service revenue in the fiscal fourth quarter equaled
$8.0 million, a 47 percent increase over the same period in 2012. Companion diagnostic revenue represented 5 percent of total revenue.
- Operating margins were 37.9 percent compared to 35.6 percent in the prior year period. The improvement in operating margins primarily was due to operating leverage realized from efficiencies in selling, general, administrative, and research expenses.
Net income for the fiscal fourth quarter was
$44.1 million, an increase of 51 percent compared to the same period of the prior year.
During the quarter the Company repurchased approximately 826,000 shares or
$21.6 millionof common stock under its previously announced stock repurchase program. Fiscal fourth quarter diluted weighted average shares outstanding were 82.6 million as compared to 86.3 million in the same period of 2012.
The Company ended the quarter with
$531.1 millionin cash, cash equivalents and marketable investment securities as compared to $454.2 millionat June 30, 2012, representing a 17 percent increase year-over-year.
Fiscal Year 2013 Results
Total revenue for fiscal year 2013 was
$613.2 million, an increase of 24 percent over the $496.0 millionreported for fiscal year 2012.
Operating income for fiscal year 2013 was
$228.0 million, an increase of 26 percent over the $180.3 millionreported for fiscal year 2012.
Net income for fiscal year 2013 totaled
$147.1 million, an increase of 31 percent over the $112.2 millionreported in the prior year.
Diluted earnings per share for fiscal year 2013 was
$1.77, an increase of 36 percent over the $1.30reported for fiscal year 2012.
During fiscal year 2013, Myriad repurchased 5.6 million shares of common stock for
$146.3 millionat an average weighted share price of $25.97.
Myriad submitted its Investigational Device Exemption to the
U.S. Food and Drug Administrationfor the use of BRACAnalysis and it has been accepted for uses as a companion diagnostic test for AstraZeneca's poly-ADP ribose (PARP) inhibitor, olaparib. AstraZeneca is planning on conducting multiple Phase III studies in collaboration with Myriad for a variety of cancers including breast, ovarian, lung and gastric cancer.
Myriad announced a new commercial agreement with Tesaro for their PARP inhibitor, niraparib. Myriad will assess BRCA status in patients to be enrolled in two separate Phase III clinical studies. This agreement marks Myriad's sixth PARP collaboration to develop a companion diagnostic for an investigational PARP inhibitor.
DaVita Labsand Myriad RBMannounced a strategic partnership where the two companies will collaborate on a research program designed to discover novel protein biomarkers to predict vascular access closure in dialysis patients. Vascular access closure causes 30 percent of the hospitalizations in dialysis patients and costs the healthcare system more than $1 billionannually. Approximately 375,000 dialysis patients in the United Statescould benefit from a potential diagnostic test in this area.
Myriad announced in May that it plans to launch myRisk Hereditary Cancer, a 25-gene panel covering six major cancers (breast, colon, ovarian, pancreatic, uterine cancer, and melanoma) offering patients the most comprehensive hereditary cancer testing available. Myriad is ahead of schedule and plans to initiate the early-access commercial launch of myRisk Hereditary Cancer in
Myriad expanded its patient financial assistance program to include underinsured patients as well as uninsured patients. Under this program, patients in need will receive free testing or pay no more than
$375for cancer predisposition testing.
Myriad presented two posters at the
American Urological Associationannual meeting further demonstrating that the PROLARIS® signature is the dominant variable in predicting prostate cancer progression. Results from these studies showed that the PROLARIS test was highly statistically significant in predicting biochemical recurrence and survival in patients following external beam radiation therapy.
Myriad completed the training set for myPath Melanoma and the data was accepted for publication at the
American Society of Dermatopathologyin October. The Company also initiated the validation study for myPlan Lung Cancerand plans to present the data this fall at a major medical meeting. Both tests are scheduled to be launched in fiscal year 2014.
Myriad Genetics GmbH, Myriad's international subsidiary, established new sales offices in Canada, Portugal, and the United Kingdomas the Company continues to aggressively expand its international presence.
Fiscal Year 2014 Financial Targets
The Company expects fiscal year 2014 total revenue of
Conference Call and Webcast
A conference call will be held on
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, Melaris, myPath Melanoma™, myPlan Lung Cancer™, myRisk Hereditary Cancer™, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company investing for future growth and launching three new tests in fiscal 2014, including myRisk Hereditary Cancer™, myPath Melanoma™, and myPlan Lung Cancer™; the Company engaging in several external collaborations, particularly in the area of companion diagnostics and personalized medicine, that have the potential to deliver long-term value to the Company's shareholders; AstraZeneca conducting multiple Phase III studies of olaparib in collaboration with the Company for a variety of cancers including breast, ovarian, lung and gastric cancer; the Company assessing BRCA status in patients to be enrolled in two separate Phase III clinical studies of Tesaro's PARP inhibitor, niraparib; the Company
|CONDENSED CONSOLIDATED INCOME STATEMENTS (Unaudited)|
|(in thousands, except per share amounts)||Three Months Ended||Twelve Months Ended|
|Molecular diagnostic testing||$ 166,089||$ 127,499||$ 582,392||$ 472,390|
|Companion diagnostic services||8,027||5,466||30,773||23,615|
|Costs and expenses:|
|Cost of molecular diagnostic testing||18,416||13,872||64,376||51,452|
|Cost of companion diagnostic services||3,657||3,081||15,242||13,207|
|Research and development expense||14,581||12,144||53,706||42,645|
|Selling, general, and administrative expense||71,546||56,583||251,839||208,383|
|Total costs and expenses||108,200||85,680||385,163||315,687|
|Other income (expense):|
|Total other income||1,312||1,186||5,274||4,222|
|Income before income taxes||67,228||48,471||233,276||184,540|
|Income tax provision (benefit)||23,153||19,330||86,137||72,389|
|Net income||$ 44,075||$ 29,141||$ 147,139||$ 112,151|
|Earnings per share:|
|Basic||$ 0.55||$ 0.35||$ 1.82||$ 1.33|
|Diluted||$ 0.53||$ 0.34||$ 1.77||$ 1.30|
|Weighted average shares outstanding|
|Condensed Consolidated Balance Sheets (Unaudited)|
|Cash, cash equivalents, and marketable investment securities||$ 531,064||$ 454,224|
|Trade receivables, net||94,333||60,441|
|Equipment and leasehold improvements, net||27,602||24,231|
|Deferred tax assets||36,639||36,220|
|Total assets||$ 803,821||$ 690,635|
|Accounts payable and accrued liabilities||$ 62,466||$ 42,913|
|Uncertain tax benefits||10,718||10,008|
|Total liabilities and stockholders' equity||$ 803,821||$ 690,635|
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