Revenue was
U.S. revenue was
More than 27,820 Oncotype DX® test results were delivered in the third quarter of 2015, compared with more than 23,700 test results delivered in the same period in 2014, an increase of 17 percent. International test results delivered grew 30 percent compared with the prior year and represented approximately 22 percent of total test volume in the third quarter of 2015.
'In the third quarter, we delivered the highest level of test growth in two years and nearly double-digit revenue growth in the U.S.,' said
Operating loss for the third quarter narrowed to
Nine Months Ended
Revenue for the nine months ended
Operating loss was
Net loss was
Cash and cash equivalents and short-term marketable securities at
'
Recent Business Highlights
Oncotype DX Commercial Progress
Palmetto GBA , a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, initiated reimbursement coverage of the Oncotype DX prostate cancer test for qualifiedMedicare patients throughoutthe United States effectiveOctober 13, 2015 .-
Expanded coverage of the Oncotype DX breast cancer test for patients with 1-3 positive nodes to include 5 million additional lives through a new policy with
Highmark Blue Cross and Blue Shield . -
The
National Institutes of Health's (NIH) Genetic Testing Registry, a free online resource to provide physicians, researchers and patients with detailed and accurate information about genetic and genomic tests, now includes information on the Oncotype DX DCIS Score™, Genomic Prostate Score and colon cancer Recurrence Score®.
Pipeline, Presentations and Publications
- The
New England Journal of Medicine published the first prospective outcomes results from the Trial Assigning IndividuaLized Options for Treatment (Rx), or TAILORx, a large multi-center trial sponsored by theNational Cancer Institute (NCI), part of theNational Institutes of Health , and led by theECOG-ACRIN Cancer Research Group , demonstrating that trial participants with low Oncotype DX Recurrence Scores of 10 or less who received hormonal therapy alone without chemotherapy had excellent outcomes, with less than a one percent chance of distant recurrence at five years. The results were also presented in a Presidential Session at the 2015European Cancer Congress (ECC2015) inVienna . - Two large international Oncotype DX clinical outcomes studies presented at ECC2015 provided additional prospective data reinforcing the ability of Oncotype DX to accurately predict clinical outcomes in early-stage breast cancer patients.
The Japan Breast Cancer Society updated its Breast Cancer Management Guidelines, recommending Oncotype DX as the only test for use in determining chemotherapy treatment in hormone receptor-positive, early-stage breast cancer.-
Presented additional positive results from the second large, independent clinical validation study of the Oncotype DX DCIS Score at the
American Society for Therapeutic Radiology and Oncology annual meeting. Results reconfirm that the test is a strong independent predictor of local recurrence, which could be either invasive breast cancer or DCIS, in patients with DCIS. - Received acceptance to present eight studies at the 2015 CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), including a poster presentation on outcomes in patients using the Oncotype DX invasive breast cancer test through a collaboration with The Surveillance, Epidemiology, and End Results (SEER) registry.
Conference Call Details
To access the live conference call today,
About Oncotype DX®
The Oncotype DX® portfolio of breast, colon and prostate cancer tests applies advanced genomic science to reveal the unique biology of a tumor in order to optimize cancer treatment decisions. With over half a million patients tested in more than 90 countries, the Oncotype DX tests have redefined personalized medicine by making genomics a critical part of cancer diagnosis and treatment. To learn more about Oncotype DX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.
About
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's belief that it is well-positioned to deliver double-digit revenue growth by the end of the year; the company's expectations regarding the timing of
NOTE: The Genomic Health logo, Oncotype, Oncotype DX, Recurrence Score, and DCIS Score are trademarks or registered trademarks of Genomic Health, Inc. All other trademarks and service marks are the property of their respective owners.
GENOMIC HEALTH, INC. Condensed Consolidated Statements of Operations (In thousands, except per share amounts) (Unaudited) | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
2015 | 2014 | 2015 | 2014 | ||||||||||
REVENUES: | |||||||||||||
Product revenues - | $ | 63,051 | $ | 57,777 | $ | 181,459 | $ | 171,863 | |||||
Product revenues - Outside of | 10,503 | 11,324 | 30,866 | 34,717 | |||||||||
Total product revenues | 73,554 | 69,101 | 212,325 | 206,580 | |||||||||
OPERATING EXPENSES (1)(2): | |||||||||||||
Cost of product revenues | 13,718 | 11,979 | 39,513 | 36,241 | |||||||||
Research and development | 13,480 | 13,891 | 47,193 | 40,527 | |||||||||
Selling and marketing | 35,369 | 34,059 | 107,964 | 102,702 | |||||||||
General and administrative | 16,425 | 15,007 | 48,594 | 44,750 | |||||||||
Total operating expenses | 78,992 | 74,936 | 243,264 | 224,220 | |||||||||
Loss from operations | (5,438) | (5,835) | (30,939) | (17,640) | |||||||||
Interest income | 54 | 47 | 163 | 144 | |||||||||
Other income (expense), net | (158) | (345) | (207) | (537) | |||||||||
Loss before income taxes | (5,542) | (6,133) | (30,983) | (18,033) | |||||||||
Income tax (benefit) expense | 6,301 | 129 | (410) | 292 | |||||||||
Net loss | $ | (11,843) | $ | (6,262) | $ | (30,573) | $ | (18,325) | |||||
Basic and diluted net loss per share | $ | (0.36) | $ | (0.20) | $ | (0.95) | $ | (0.58) | |||||
Shares used in computing basic and diluted net loss per share | 32,498 | 31,590 | 32,294 | 31,339 | |||||||||
(1) | Included in operating expenses for the three months ended |
(2) | Included in operating expenses for the nine months ended |
GENOMIC HEALTH, INC. Condensed Consolidated Balance Sheets (In thousands) | ||||||
As of
|
As of | |||||
(Unaudited) | ||||||
Cash and cash equivalents | $ | 28,010 | $ | 29,726 | ||
Short-term marketable securities (1) | 70,003 | 73,934 | ||||
Accounts receivable, net | 33,754 | 34,916 | ||||
Prepaid expenses and other current assets | 10,238 | 9,944 | ||||
Total current assets | 142,005 | 148,520 | ||||
Property and equipment, net | 34,682 | 21,860 | ||||
Other assets | 1,656 | 15,541 | ||||
Total assets | $ | 178,343 | $ | 185,921 | ||
Accounts payable | $ | 5,595 | $ | 6,987 | ||
Accrued expenses and other current liabilities | 37,674 | 31,016 | ||||
Deferred revenues | 251 | 335 | ||||
Other liabilities | 2,294 | 2,070 | ||||
Stockholders' equity | 132,529 | 145,513 | ||||
Total liabilities and stockholders' equity | $ | 178,343 | $ | 185,921 |
The condensed consolidated balance sheet at | |
(1) | Included in short-term marketable securities as of |
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