Genomic Health Announces Second Quarter 2014 Financial Results and Business Progress

 Genomic Health Announces Second Quarter 2014 Financial Results and Business                                    Progress  17% Increase in Test Volume, 11% Increase in Total Revenue and 29% Increase in International Product Revenue Compared to Prior Year  Positive Topline Results from Additional, Large Clinical Validation Study of Oncotype DX® Prostate Cancer Test with Multiple Clinical Endpoints  Positive Results from Second, Large Ductal Carcinoma In Situ (DCIS) Clinical Validation Study Submitted for Presentation at the San Antonio Breast Cancer Symposium in December  Conference Call Today at 4:30 p.m. ET  PR Newswire  REDWOOD CITY, Calif., Aug. 7, 2014  REDWOOD CITY, Calif., Aug. 7, 2014 /PRNewswire/ -- Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended June 30, 2014.  Product revenue was $70.5 million in the second quarter of 2014, compared with $63.7 million for the second quarter of 2013, an increase of 11 percent. There was no contract revenue in either period.  International product revenue grew by 29 percent to $11.9 million compared to the same period last year and represented 17 percent of product revenue in the second quarter of 2014.  Net loss in the second quarter of 2014 was $4.6 million, compared with a net loss of $3.0 million in the second quarter of 2013. Basic and diluted net loss per share applicable to common stockholders was $0.15 for the second quarter of 2014, compared with a basic and diluted net loss per share of $0.10 for the same period in 2013.  "In the second quarter, we delivered 17 percent growth in test volume and double-digit revenue growth by increasing penetration of the U.S. invasive breast cancer market and through continued strong international adoption and reimbursement success," said Kim Popovits, Chairman of the Board, Chief Executive Officer and President of Genomic Health. "Additionally, we delivered strong prostate cancer test growth and announced positive results from an additional large clinical validation study, which we believe will drive reimbursement and further adoption of our test. We look forward to presenting complete results from this study and the landmark DCIS breast cancer study later this year."  Additional Second Quarter 2014 and Six Months Ended June 30, 2014 Financial Results  Total operating expenses for the second quarter of 2014 were $75.1 million, compared with total operating expenses for the comparable period in 2013 of $66.6 million.  Product revenue for the six months ended June 30, 2014 was $137.5 million, compared with $126.4 million for the six months ended June 30, 2013, an increase of 9 percent. Total revenue for the six months ended June 30, 2014 was $137.5 million, compared to $126.8 million for the comparable period in 2013.  Net loss was $12.1 million for the six months ended June 30, 2014, compared with a net loss of $3.9 million for the six months ended June 30, 2013.  Cash and cash equivalents and short-term investments at June 30, 2014 were $105.7 million, compared with $105.4 million at December 31, 2013.  In the second quarter, more than 24,050 Oncotype DX^® test results were delivered, an increase of 17 percent, compared with more than 20,650 test results delivered in the same period in 2013. International test results grew 32 percent during the quarter and represented approximately 20 percent of total test volume in the quarter.  "Our first half net loss reflects planned investments in the international and prostate cancer markets," said Brad Cole, Chief Operating Officer and Chief Financial Officer of Genomic Health. "We anticipate planned investments in DCIS, prostate and international markets to continue through the end of the year, resulting in second half net losses similar to the first half."  Recent Business Highlights:  Oncotype DX Commercial Progress    oIn Canada, established Oncotype DX breast cancer test coverage for an     additional 3.6 million lives in the province of Alberta, bringing the     total lives covered to more than 86 percent of the country's population.   oIn Spain, the Agency for Health Technology Assessment of Andalusia (AETSA)     published the Evaluation Report of Genomic Platforms, recommending     Oncotype DX as the only breast cancer test to support therapeutic     decision-making in patients with early-stage, hormone receptor-positive,     invasive breast cancer.   oIn Mexico, private health insurer AXA granted reimbursement for the     Oncotype DX breast cancer test, covering 1.2 million lives.   oAnnounced that the Oncotype DX breast cancer test was the first multi-gene     test for cancer management to be included in the National Institutes of     Health's genetic testing registry.   oEstablished Medicaid coverage in three additional states for the Oncotype     DX breast cancer test.  Pipeline, Presentations and Publications    oAnnounced positive preliminary results from an additional independent     clinical validation study conducted by the Center for Prostate Disease     Research (CPDR), demonstrating that the Oncotype DX Genomic Prostate Score     (GPS) predicts multiple clinical endpoints related to disease     aggressiveness in men with low- and intermediate-risk prostate cancer.     This study validated the Oncotype DX prostate cancer test as a predictor     of biochemical recurrence, a rise in prostate-specific antigen (PSA)     following surgery, which is a longer-term measure of outcomes for     aggressive disease. It also reconfirmed the test's ability to predict     adverse pathology from the biopsy, as previously demonstrated in a     published validation study performed by the University of California, San     Francisco (UCSF).   oAnnounced positive preliminary results from a large, independent clinical     validation study of Oncotype DX in patients with a pre-invasive form of     breast cancer, also known as DCIS (ductal carcinoma in situ). Complete     data has been submitted for presentation at the 2014 San Antonio Breast     Cancer Symposium.   oEuropean Urology published groundbreaking results from three studies     demonstrating that the Oncotype DX prostate cancer test predicts     aggressiveness at diagnosis and significantly increases the number of     low-risk patients who can confidently choose active surveillance.   oPresented results from nine abstracts at the American Society of Clinical     Oncology^® (ASCO^®) Annual Meeting, including data demonstrating that the     Oncotype DX breast cancer test predicts late recurrence five to 15 years     out; the unique, practice-changing impact of Oncotype DX to optimize     cancer care; and the importance of utilizing multiple biological pathways     to predict tumor behavior in prostate and renal cancers.   oPresented results of a new analysis suggesting that the Oncotype DX     prostate cancer test predicts recurrence risk after prostatectomy,     regardless of post-surgery treatment, at the American Urological     Association (AUA) Annual Meeting.   oReceived acceptance to present one study at the upcoming ASCO Breast     Cancer Symposium September 4-6.   oReceived acceptance to present two studies at the upcoming American     Society of Radiation Oncology^® (ASTRO^®) Meeting September 14-17.   oReceived acceptance to present eight studies in multiple tumor types at     the upcoming European Society of Medical Oncology^® (ESMO^®) Congress     September 26-30.  Conference Call Details To access the live conference call today, August 7 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 66377262. 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 company's 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 world's 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 datainto clinically-actionable results for treatment planning throughout the cancer patient's journey, from screening and surveillance, through diagnosis, treatment selection and monitoring. Genomic Health's 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 June 30, 2014, more than 19,000 physicians in over 70 countries had ordered more than 465,000 Oncotype DX tests. The company is based in Redwood City, California with European headquarters in Geneva, Switzerland. For more information, please visit, www.GenomicHealth.com and follow the company on Twitter: @GenomicHealth. To learn more about OncotypeDX tests, visit: www.OncotypeDX.com, www.mybreastcancertreatment.org and www.myprostatecancertreatment.org.  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 positive study results will drive further reimbursement and adoption of its prostate cancer test; the company's expectations regarding reporting study results; the company's intent to continue its investments in DCIS, prostate cancer and international markets; the company's expectations regarding second half financial results; the attributes and focus of the company's product pipeline; the applicability of clinical study results to actual outcomes; the company's beliefs regarding the benefits and attributes of its tests; the ability of any potential tests the company may develop to optimize cancer treatment; and the ability of the company to develop and commercialize additional tests in the future. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: the risks and uncertainties associated with the regulation of the company's tests; the results of clinical studies and their impact on reimbursement and adoption; the applicability of clinical study results to actual outcomes; the company's ability to develop and commercialize new tests and expand into new markets domestically and internationally; the risk that the company may not obtain or maintain sufficient levels of reimbursement, domestically or abroad, for its existing tests and any future tests it may develop; the risks of competition; unanticipated costs or delays in research and development efforts; the company's ability to obtain capital when needed and the other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2014. These forward-looking statements speak only as of the date hereof. Genomic Health disclaims any obligation to update these forward-looking statements.  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)                                   ThreeMonthsEnded    SixMonthsEnded                                   June30,              June30,                                   2014       2013       2014        2013 REVENUES: Product revenues                  $ 70,477   $ 63,691   $ 137,479   $ 126,400 Contract revenues                 -          -          -           385 Total revenues                    70,477     63,691     137,479     126,785 OPERATING EXPENSES (1)(2): Cost of product revenues          12,207     10,757     24,262      20,503 Research and development          13,295     13,800     27,976      27,463 Selling and marketing             34,571     28,135     67,303      55,574 General and administrative        15,015     13,910     29,743      27,045 Total operating expenses          75,088     66,602     149,343     130,585 Loss from operations              (4,611)    (2,911)    (11,805)    (3,800) Interest income                   47         57         97          122 Other income (expense), net       34         (85)       (192)       (91) Loss before income taxes          (4,530)    (2,939)    (11,900)    (3,769) Income tax expense                88         55         163         108 Net loss                          $ (4,618)  $ (2,994)  $ (12,063)  $ (3,877) Basic and diluted net loss per    $ (0.15)   $ (0.10)   $ (0.39)    $ (0.13) share Shares used in computing basic    31,333     30,302     31,211      30,236 and diluted net lossper share        Included in operating expenses for the three months ended June 30, 2014     were non-cash charges of $6.1 million, including $4.3 million of     stock-based compensation expense and $1.8 million of depreciation and (1) amortization expenses, compared with non-cash charges for the same period     in 2013 of $6.1 million, including $4.4 million of stock-based     compensation expense and $1.7 million of depreciation and amortization     expenses.     Included in operating expenses for the six months ended June 30, 2014 were     non-cash charges of $12.1 million, including $8.6 million of stock-based (2) compensation expense and $3.5 million of depreciation and amortization     expenses, compared with non-cash charges for the same period in 2013 of     $11.6 million, including $8.5 million of stock-based compensation expense     and $3.1 million of depreciation and amortization expenses.      GENOMIC HEALTH, INC. Condensed Consolidated Balance Sheets (In thousands)                                                 As of                                                            As of December31,                                                 June30,   2013                                                 2014                                                 (Unaudited) Cash and cash equivalents                       $ 32,494   $      33,279 Short-term marketable securities                73,209     72,071 Accounts receivable, net                        31,771     29,446 Prepaid expenses and other current assets       9,014      10,196 Total current assets                            146,488    144,992 Property and equipment, net                     17,342     18,290 Other assets                                    14,120     13,752 Total assets                                    $ 177,950  $      177,034 Accounts payable                                $ 5,560    $      5,160 Accrued expenses and other current liabilities  26,581     24,086 Deferred revenues                               273        586 Other liabilities                               2,083      2,221 Stockholders' equity                            143,453    144,981 Total liabilities and stockholders' equity      $ 177,950  $      177,034  The condensed consolidated balance sheet at December 31, 2013 has been derived from the audited consolidated financial statements at that date included in the Company's Form 10-K for the year ended December 31, 2013.    Genomic Health, Inc. logo.  Logo - http://photos.prnewswire.com/prnh/20130425/SF01493LOGO  SOURCE Genomic Health, Inc.  Website: http://www.GenomicHealth.com Contact: Investors: Emily Faucette, Genomic Health, 650-569-2824, nvestors@genomichealth.com, or Media: Victoria Steiner, Genomic Health, 650-569-2499, media@genomichealth.com  
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