On May 9, 2017 Genomic Health, Inc. (Nasdaq: GHDX) reported financial results and business progress for the quarter ended March 31, 2017 (Filing, Q1, Genomic Health, 2017, MAY 9, 2017, View Source [SID1234518947]).

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Total revenue was $84.0 million in the first quarter of 2017, compared with $80.9 million in the first quarter of 2016, an increase of 4 percent.

U.S. product revenue was $70.6 million in the first quarter of 2017, compared with $70.5 million in the first quarter of 2016. U.S. invasive breast revenue was $64.8 million in the first quarter of 2017, compared with $64.1 million in the first quarter of 2016. U.S. prostate revenue was $3.3 million in the first quarter of 2017, compared with $2.6 million in the first quarter of 2016.

International product revenue was $13.4 million in the first quarter of 2017, compared with $10.4 million in the first quarter of 2016, an increase of 29 percent, and an increase of 33 percent on a constant currency basis.i

"Strong demand for our Oncotype tests in the first quarter of 2017 was due, in part, to growth across our U.S. prostate and global invasive breast business, including four percent sequential growth in U.S. invasive breast cancer. Importantly, for the seventh consecutive quarter, we delivered operating leverage and improved operating income by $6 million in the first quarter," said Kim Popovits, chairman of the board, chief executive officer and president of Genomic Health. "Additionally, last week Palmetto GBA issued a draft local coverage determination that recommends Medicare coverage expansion for the Oncotype DX Genomic Prostate Score to include intermediate-risk patients. Reimbursement progress remains a critical growth driver as we aim to deliver double-digit revenue growth in the second half of the year with continued profitability improvement."

Operating loss for the first quarter of 2017 improved to $2.8 million, compared with $8.8 million for the first quarter of 2016. Net loss was $0.8 million, or 2 cents per share, for the first quarter of 2017, compared with a net loss of $6.4 million, or 19 cents per share, for the first quarter of 2016. Basic and diluted net loss per share was $0.02 for the first quarter of 2017, compared with a basic and diluted net loss per share of $0.19 for the first quarter of 2016.

More than 31,580 Oncotype test results were delivered in the first quarter of 2017, an increase of 7 percent, compared with more than 29,510 test results delivered in the same period in 2016. Oncotype DX Breast Recurrence Score tests delivered in the U.S. grew 1 percent and Oncotype DX Genomic Prostate Score tests delivered in the U.S. grew 40 percent compared with the prior year. International tests delivered grew 17 percent compared with the prior year and represented approximately 25 percent of total test volume in the first quarter of 2017.

Cash and cash equivalents and short-term marketable securities at March 31, 2017 were $94.4 million, compared with $87.7 million at December 31, 2016 excluding the fair value of the company’s investment in a marketable security of $9.3 million.

Recent Business Highlights

· Palmetto GBA, a Medicare Administrative Contractor (MAC) that assesses molecular diagnostic technologies, issued a draft local coverage determination (LCD) for the Oncotype DX Genomic Prostate Score (GPS) expanding Medicare coverage to include qualified patients with favorable intermediate-risk prostate cancer throughout the United States.

· Presented results from four studies evaluating the clinical validation and utility of the GPS in the management of early-stage prostate cancer at the 2017 Genitourinary (GU) Cancers Symposium. Collectively, these new data highlight the test’s ability to predict disease aggressiveness and refine risk stratification across National Comprehensive Cancer Network (NCCN) clinical risk groups.

· Presented results from a large multi-center clinical validation study that used a longitudinal patient database from Kaiser Permanente’s Northern California region demonstrating that the GPS predicts 10-year risk of developing metastatic prostate cancer. Designated one of the ‘Best Posters’ at the 32nd Annual European Association of Urology (EAU) Congress, results highlight the expanded value of the test in assessing risk and long-term outcomes in newly diagnosed prostate cancer patients.

· Later this week, additional results from the Kaiser validation study, which also analyzed the GPS performance in predicting prostate cancer-specific death, will be presented at the American Urological Association (AUA) 2017 Annual Meeting.

· Three additional Oncotype DX GPS studies demonstrating prospective and additional clinical utility, including persistence on active surveillance, will also be presented at AUA.

· The German Association of Gynecological Oncology’s (AGO’s) updated treatment guidelines reconfirm Oncotype DX with the highest 1A level of evidence and recognize it as the only multi-gene



breast cancer test available to predict chemotherapy benefit for women with early-stage, hormone-receptor positive, HER2-negative invasive breast cancer.

· Established an agreement with an additional German public health insurance fund, covering 2.5 million lives, to begin offering Oncotype DX to early-stage breast cancer patients.

· Presented results at the 15th St. Gallen International Breast Cancer Conference from 15 Oncotype DX Breast Recurrence Score studies conducted in 12 countries that provide real-world evidence of the test’s ability to change treatment decisions for breast cancer patients.

· The journal Breast Cancer Research and Treatment published results from the National Cancer Institute’s (NCI) Surveillance, Epidemiology, and End Results (SEER) Registry, which demonstrated that many node-positive breast cancer patients can avoid chemotherapy based on their Oncotype DX Breast Recurrence Score.

· The Journal of Surgical Oncology published results from a multicenter trial, which demonstrated that the Oncotype DX Breast Recurrence Score can guide neoadjuvant therapy to help facilitate breast-conserving surgery for hormone receptor-positive breast cancer patients.

· Received acceptance to present eight Oncotype DX studies at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June.

Conference Call Details

To access the live conference call today, May 9 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 10366777. 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 View Source Please connect to the web site at least 15 minutes prior to the call to allow for any software download that may be necessary.