Genomic Health Announces First Quarter 2014 Financial Results And Business Progress
The following excerpt is from the company's SEC filing
REDWOOD CITY, Calif., [May 6, 2014] Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended March 31, 2014.
Product revenue was $67.0 million in the first quarter of 2014, compared with $62.7 million for the first quarter of 2013, an increase of 7 percent. Total revenue for the first quarter of 2014 was $67.0 million, compared with $63.1 million in the first quarter of 2013.
International product revenue grew by 35 percent to $11.5 million compared to the same period last year and represented 17 percent of product revenue in the first quarter of 2014.
Net loss in the first quarter of 2014 was $7.4 million, compared with net loss of $0.9 million in the first quarter of 2013. Basic and diluted net loss per share applicable to common stockholders was $0.24 for the first quarter of 2014, compared with a basic and diluted net loss per share of $0.03 for the same period in 2013.
In the first quarter, we again expanded our U.S. breast cancer penetration, achieved strong international growth and drove adoption of our prostate cancer test, said Kim Popovits, Chairman of the Board, Chief Executive Officer and President of Genomic Health. We are executing on our planned investments to maximize significant international and prostate opportunities, and are on track to report topline results from additional pivotal studies in DCIS breast and prostate cancer mid-year.
Additional First Quarter 2014 Financial Results
Total operating expenses for the first quarter of 2014 were $74.2 million, compared with total operating expenses for the comparable period in 2013 of $64.0 million.
Cash and cash equivalents and short-term and long-term investments at March 31, 2014 were $102.1 million, compared with $105.4 million at December 31, 2013.
In the first quarter, more than 23,080 Oncotype DX® test results were delivered, an increase of 13 percent, compared with 20,350 test results delivered in the same period in 2013. International test results grew 43 percent during the quarter and now represent 20 percent of total test volume.
Recent Business Highlights:
Oncotype DX Commercial Progress
· The American Medical Association (AMA) granted a test-specific Current Procedural Terminology (CPT) code for the Oncotype DX breast cancer test, making it the first and only test to meet Category 1 utilization and evidence requirements for risk of recurrence and chemotherapy prediction.
· Palmetto GBA, the designated national contractor for molecular diagnostic tests including the Oncotype DX colon cancer test, expanded its coverage policy for all qualified Medicare patients beyond stage II disease to now include select stage III A/B patients.
· In Canada, established coverage for an additional 5 million lives with the BC Cancer Agency in British Columbia, bringing the total lives covered to more than 80 percent of the countrys population.
· The AGO (Gynecologic Oncology Working Group) in Germany updated guidelines to recommend Oncotype DX as the only breast cancer gene expression test to predict chemotherapy benefit in early-stage, hormone receptor-positive invasive breast cancer.
· Established first policy with a private insurer in Switzerland.
· Established node-positive and ductal carcinoma in situ (DCIS) breast cancer coverage for an additional 5 million lives in the United States through contracts with large Blue Cross Blue Shield state plans.
Pipeline, Presentations and Publications
· Presented results from multiple Oncotype DX breast cancer studies at the 9th European Breast Cancer Conference (EBCC-9) in March that further support the increasing adoption of the test in Europe.
· Presented four studies at the United States & Canadian Academy of Pathologys (USCAP) annual meeting in March including results from one of the largest male breast cancer genomic studies ever reported.
· The Oncologist published positive results from an Oncotype DX colon cancer decision impact study demonstrating that Recurrence Score® results changed treatment recommendations in 45 percent of stage II colon cancer patients.
· Received acceptance to present nine abstracts at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting May 30 - June 3, including studies in breast, colon, prostate, and renal cancers.
· Scheduled to present new information about the Oncotype DX prostate cancer test at the upcoming American Urological Association (AUA) Annual Meeting May 16 - 21, including a physician-led symposium about the integration of the test into clinical practice.
Conference Call Details
To access the live conference call today, May 6 at 4:30 p.m. Eastern Time via phone, please dial (877) 303-7208 from the United States and Canada or +1(224) 357-2389 internationally. The conference ID is 24955534. Please dial in approximately ten minutes prior to the start of the call. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the companys website at http://investor.genomichealth.com/events.cfm. Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.
About Genomic Health
Genomic Health, Inc. (NASDAQ: GHDX) is the worlds leading provider of genomic-based diagnostic tests that address both the overtreatment and optimal treatment of early stage cancer, one of the greatest issues in healthcare today. The company is applying its world-class scientific and commercial expertise and infrastructure to lead the translation of massive amounts of genomic data into clinically-actionable results for treatment planning throughout the cancer patients journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Healths lead product, the Oncotype DX® breast cancer test, has been shown to predict the likelihood of chemotherapy benefit as well as recurrence in invasive breast cancer and has been shown to predict the likelihood of recurrence in ductal carcinoma in situ (DCIS). In addition to this widely adopted test, Genomic Health provides the Oncotype DX colon cancer test, the first multi-gene expression test developed for the assessment of risk of recurrence in patients with stage II and stage III disease, and the Oncotype DX prostate cancer test, which predicts disease aggressiveness in men with low risk disease. As of March 31, 2014, more than 19,000 physicians in over 70 countries had ordered approximately 440,000 Oncotype
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)
Three Months Ended March 31,
OPERATING EXPENSES (1):
Cost of product revenues
Research and development
Selling and marketing
General and administrative
Total operating expenses
Income (loss) from operations
Other income (expense), net
Income (loss) before income taxes
Income tax expense
Net income (loss)
Basic net income (loss) per share
Diluted net income (loss) per share
Shares used in computing basic net income (loss) per share
Shares used in computing diluted net income (loss) per share
(1) Included in operating expenses for the first quarter of 2014 were non-cash charges of $6.1 million, including $4.4 million of stock-based compensation expense and $1.7 million of depreciation and amortization expenses, compared with non-cash charges for the same period in 2013 of $5.9 million, including $4.4 million of stock-based compensation expense and $1.5 million of depreciation and amortization expenses.
GENOMIC HEALTH, INC.
Condensed Consolidated Balance Sheets
As of March 31, 2014
As of December 31, 2013
Cash and cash equivalents
Short-term marketable securities
Accounts receivable, net
Prepaid expenses and other current assets
Total current assets
Property and equipment, net
Accrued expenses and other current liabilities
Total liabilities and stockholders equity
The condensed consolidated balance sheet at December 31, 2013 has been derived from the audited consolidated financial statements at that date included in the Companys Form 10-K for the fiscal year ended December 31, 2013
The above information was disclosed in a filing to the SEC. To see this filing in its entirety, click here. Genomic Health next reports earnings on May 06, 2014.
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