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Genomic Health Announces Second Quarter 2008 Financial Results and Business Progress

2008-08-05 15:02:00

Genomic Health Announces Second Quarter 2008 Financial Results and Business Progress

  - Product Revenue Increased 81 Percent; Tests Delivered Grew 69 Percent

                              Year over Year -

                      - Net Loss Continued to Narrow -

                     - Company Updates 2008 Guidance -

                 - Conference Call Today at 4:30 p.m. ET -



    REDWOOD CITY, Calif., Aug. 5 /EMWNews/ -- Genomic Health,

Inc. (Nasdaq: GHDX) today reported financial results and business progress

for the quarter ended June 30, 2008.



    Total revenue increased to $27.8 million in the second quarter of 2008

compared to $14.7 million in the second quarter of 2007. Product revenue

from the Oncotype DX(R) breast cancer assay was $26.3 million in the second

quarter of 2008, an increase of 81 percent compared to $14.6 million in the

second quarter of 2007, the result of continued growth in adoption and

reimbursement. Contract revenue was $1.5 million in the second quarter of

2008, compared to $135,000 in the second quarter of 2007, reflecting

continued collaboration with pharmaceutical partners to explore the

development of tests for predicting benefit from certain targeted

therapies.



    "We believe the increasing impact of personalized medicine and our

investment in Oncotype DX are reflected not only in our strong revenue and

growth in tests delivered, but also in the narrowing of our net loss in the

second quarter," said Randy Scott, Ph.D., chairman and chief executive

officer of Genomic Health. "While we work to further reduce our net loss,

we will continue to invest in our product pipeline and expand our

commercial efforts outside of the United States, which we expect to be

important components of future growth."



    Additional Second Quarter 2008 Financial Results



    During the second quarter of 2008, approximately 51 percent of product

revenue was recorded on an accrual basis and recognized at the time the

test results were delivered, reflecting established payment patterns from

payors with coverage policies in place.



    Cost of product revenue was $6.9 million in the second quarter of 2008,

compared to $4.2 million for the second quarter of 2007. Research and

development expenses for the second quarter of 2008 were $7.3 million,

compared to $5.2 million for the same period in 2007. Selling and marketing

and general and administrative expenses for the second quarter of 2008 were

$18.1 million, compared to $12.9 million for the same period in 2007.

Included in second quarter 2008 operating expenses was $2.3 million of

stock-based compensation expense, compared to $1.5 million in the same

period in 2007.



    Net loss was $4.1 million in the second quarter of 2008, compared to

$7.2 million in the second quarter of 2007. Basic and diluted net loss per

share was $0.15 in the second quarter of 2008, compared to a net loss per

share of $0.28 in the second quarter of 2007.



    Financial Results for Six Months Ended June 30, 2008



    Total revenue for the six months ended June 30, 2008 was $51.2 million,

compared to $28.8 million for the first six months of 2007. Product revenue

for the six months ended June 30, 2008 was $49.7 million, compared to $27.7

million for the first six months of 2007. Contract revenue constituted the

balance of revenue for the first six months of 2008 and 2007.



    Cost of product revenue for the six months ended June 30, 2008 was

$12.7 million, compared to $8.0 million for the comparable period in 2007.

Research and development expenses for the first six months of 2008 were

$13.7 million, compared to $10.4 million in the first six months of 2007.

Selling and marketing and general and administrative expenses for the first

six months of 2008 were $36.3 million, compared to $25.2 million in the

first six months of 2007. The increase in expenses includes stock-based

compensation expense of $4.5 million in the first six months of 2008

compared to $2.8 million for the same period in 2007.



    Net loss for the six months ended June 30, 2008 was $10.7 million,

compared to $14.0 million for the first six months of 2007. Basic and

diluted net loss per share was $0.38 for the six months ended June 30,

2008, compared to a net loss per share of $0.55 for the first six months of

2007.



    Cash and Cash Equivalents



    Cash and cash equivalents and investments at June 30, 2008 were $60.6

million compared to $65.4 million at March 31, 2008 and $68.4 million at

December 31, 2007.



    Updated 2008 Outlook and Financial Guidance



    The company is providing the following revised guidance for the full

year ending December 31, 2008:




-- Increasing expected test results delivered to 38,000 to 40,000 test results, from previous guidance of 34,000 to 37,000 test results. -- Projecting total revenue in a range between $105 million and $110 million, compared to previous guidance of $100 million to $110 million, with an expectation that full-year revenue may be at the higher end of this guidance. -- Continuing to expect net loss of $15 million to $20 million for 2008, with the net loss narrowing in the second half of 2008 as compared to the first half of 2008. Recent Highlights and Accomplishments Physician Usage and Adoption -- More than 9,690 test results were delivered in the second quarter of 2008, compared to more than 5,750 test results delivered in the second quarter of 2007. -- More than 18,850 test results were delivered in the first half of 2008, compared to more than 11,200 test results delivered in the first half of 2007. -- More than 65,000 Oncotype DX test results have been delivered to patients. Peer-Reviewed Publications and Medical Meeting Presentations -- The Journal of Clinical Oncology published a study online showing that the Oncotype DX Recurrence Score provides additional prognostic information in patients with early-stage breast cancer beyond that derived from Adjuvant! Online, an online tool that evaluates clinical variables to help physicians and patients assess the risks and benefits of getting additional therapy after surgery. -- Two abstracts were accepted for presentation at the ASCO Breast Cancer Symposium in September of 2008. -- The Journal of Clinical Oncology published results of a study demonstrating the utility of Oncotype DX in measuring quantitative gene expression for ER and PR status, indicating that quantitative RT-PCR, as performed in the Oncotype DX breast cancer assay, is a reliable method for determining hormone receptor status in breast cancer. -- Presented results from two initial studies with collaborators that could lead to the development of new tests for predicting benefit from certain targeted therapies in cancer, at the 2008 ASCO meeting in June. Reimbursement Progress for Oncotype DX -- In June, Palmetto GBA, the company that will replace National Heritage Insurance Company (NHIC) as the Medicare administrative contractor, posted local coverage decisions for its jurisdiction that included Oncotype DX. This coverage decision follows the identical criteria previously set forth by NHIC. We expect to begin processing claims with Palmetto in September of 2008. -- Gained coverage for over 6.9 million additional lives for access to Oncotype DX. o Blue Cross Blue Shield plans of Louisiana, Mississippi and Northeastern Pennsylvania established policies covering approximately 2.3 million lives. o Group Health Incorporated and HIP Health Plan of New York established policies covering approximately 4.6 million lives. Product Pipeline Breast Cancer -- Targeting inclusion of quantitative HER2 scores in all Oncotype DX reports by the end of 2008. -- Conducting a study using Oncotype DX in breast cancer patients treated with aromatase inhibitors with the goal of reporting results this year. Colon Cancer -- Received first trial specimens for our clinical validation study, which we expect to begin in the second half of 2008. -- Received milestone payment from Bristol-Myers Squibb related to Genomic Health's program to identify genes to predict response to cetuximab (Erbitux(R)). Other Cancers -- Established collaborators and identified sources of clinical samples to further our prostate and lung cancer programs. -- Began gene identification work to develop a prognostic test for patients with renal cell carcinoma, clear cell type, under the Pfizer collaboration announced in January of 2008. International -- Initiated a study supporting Japanese investigators as they gain clinical experience with Oncotype DX for early-stage breast cancer patients. -- Processing samples from patients in Canada, Ireland and Peru enrolled in the National Cancer Institute-sponsored TAILORx study, which has expanded internationally. Conference Call Details To access the live conference call today, August 5, at 4:30 p.m. Eastern Time via phone, please dial (877) 356-8064 from the United States and Canada or (706) 758-4314 internationally. The conference ID is 56195752. Please dial in approximately ten minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through August 12 and may be accessed by dialing (800) 642-1687 from the United States and Canada or (706) 645-9291 internationally. The replay passcode is 56195752. To access the live and subsequently archived webcast of the conference call, go to the Investor Relations section of the company's Web site at http://investor.genomichealth.com. 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 a life science company focused

on the development and commercialization of genomic-based clinical

laboratory services for cancer that allow physicians and patients to make

individualized treatment decisions. In 2004, Genomic Health launched its

first test, Oncotype DX(R), which has been shown to predict the likelihood

of breast cancer recurrence and the likelihood of chemotherapy benefit in a

large portion of early-stage breast cancer patients. The company was

founded in 2000 and is located in Redwood City, California. For more

information, please visit http://www.genomichealth.com.



    This press release contains forward-looking statements within the

meaning of the Private Securities Litigation Reform Act of 1995, including

statements relating to our ability to further reduce our net loss; our

ability to expand our efforts outside of the United States; our expectation

that we will continue to invest in our product pipeline; the expected

components of any future growth in our business; our plans to broaden the

clinical utility of Oncotype DX to include reporting of quantitative HER2

scores; the results of a study regarding patients treated with aromatase

inhibitors and our goals with respect to reporting results of that study;

the timing of a validation study for a potential assay for colon cancer;

the outcome of our study in Japan; our ability to develop a test for

patients with renal cell carcinoma, clear cell type and the success of our

collaboration with Pfizer; the outcome or success of planned or ongoing

clinical trials and our expectations regarding potential clinical outcomes;

the applicability of clinical study results to actual outcomes; the impact

of the inclusion of Oncotype DX in treatment guidelines, additional

clinical studies and our commercial efforts on continuing growth in

adoption, reimbursement and revenue growth; our expectations regarding

coverage for our test by Palmetto, the new Medicare administrative

contractor for our test; and our revised 2008 financial guidance regarding

expected range of test results delivered, our range of expected total

revenue and our range of expected net loss. 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: our ability to increase usage of our test; the risk

that we may not obtain or maintain sufficient levels of reimbursement for

our existing test and any future tests we may develop; the risks and

uncertainties associated with the regulation of our tests by FDA; our

ability to compete against third parties; our ability to develop and

commercialize new tests; the results of clinical trials; unanticipated

costs or delays in research and development efforts; our ability to obtain

capital when needed; our history of operating losses; the results of

clinical studies and the other risks set forth in our filings with the

Securities and Exchange Commission, including the risks set forth in our

Quarterly Report on Form 10-Q for the quarter ended March 31, 2008. 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 and Recurrence

Score are trademarks or registered trademarks of Genomic Health, Inc. All

other trademarks and service marks are the property of their respective

owners.




(Financial statements below) Genomic Health, Inc. Condensed Consolidated Statements of Operations (in thousands, except share and per share data) For the Three Months For the Six Months Ended Ended June 30, June 30, 2008 2007 2008 2007 (Unaudited) (Unaudited) REVENUES: Product revenues $26,327 $14,555 $49,682 $27,701 Contract revenues 1,456 135 1,541 1,077 Total revenues 27,783 14,690 51,223 28,778 OPERATING EXPENSES: Cost of product revenues 6,850 4,172 12,734 8,019 Research and development 7,322 5,224 13,728 10,394 Selling and marketing 11,827 8,740 24,194 16,893 General and administrative 6,225 4,186 12,130 8,275 Total operating expenses 32,224 22,322 62,786 43,581 Loss from operations (4,441) (7,632) (11,563) (14,803) Other income (expense): Interest income 448 612 1,069 1,128 Interest and other expense (106) (178) (239) (373) Net loss $(4,099) $(7,198) $(10,733) $(14,048) Basic and diluted net loss per share $(0.15) $(0.28) $(0.38) $(0.55) Shares used to compute basic and diluted net loss per share 28,262,407 26,141,476 28,239,908 25,355,685 Genomic Health, Inc. Condensed Consolidated Balance Sheets (in thousands) As of As of 30-Jun-08 31-Dec-07 (Unaudited) (Audited) Cash and cash equivalents $17,222 $39,164 Short-term investments 43,405 29,196 Accounts receivable, net 7,360 5,089 Prepaid expenses and other current assets 4,649 3,105 Total current assets 72,636 76,554 Property and equipment, net 13,041 10,412 Restricted cash 500 500 Other assets 411 463 Total assets $86,588 $87,929 Accounts payable $1,913 $1,966 Accrued expenses and other current liabilities 9,975 7,616 Deferred revenue 4,168 1,008 Notes payable, current 2,405 2,687 Notes payable, long-term 940 2,039 Other liabilities 1,695 1,447 Stockholders' equity 65,492 71,166 Total liabilities and stockholders' equity $86,588 $87,929 The condensed consolidated balance sheet at December 31, 2007 has been derived from the audited consolidated financial statements at that date included in the Company's Form 10-K for the fiscal year ended December 31, 2007.

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Blake Masterson

Freelance Writer, Journalist and Father of 5

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