-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, CAOtJPawQHcGjcG/a6E/bA8gdQySDyWtuvlL8sJEcUZ0bSbRmMaVJJJzltLplquC FHwyBtYbVzJ8NS/1JEQ6jg== 0000891618-09-000158.txt : 20090505 0000891618-09-000158.hdr.sgml : 20090505 20090505160411 ACCESSION NUMBER: 0000891618-09-000158 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090505 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090505 DATE AS OF CHANGE: 20090505 FILER: COMPANY DATA: COMPANY CONFORMED NAME: GENOMIC HEALTH INC CENTRAL INDEX KEY: 0001131324 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-MEDICAL LABORATORIES [8071] IRS NUMBER: 770552594 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51541 FILM NUMBER: 09797743 BUSINESS ADDRESS: STREET 1: 301 PENOBSCOT DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 BUSINESS PHONE: 650-556-9300 MAIL ADDRESS: STREET 1: 301 PENOBSCOT DRIVE CITY: REDWOOD CITY STATE: CA ZIP: 94063 8-K 1 f52348e8vk.htm FORM 8-K e8vk
 
 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 5, 2009
GENOMIC HEALTH, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   000-51541   77-0552594
(State or Other Jurisdiction of
Incorporation)
  (Commission File Number)   (I.R.S. Employer
Identification No.)
     
301 Penobscot Drive
Redwood City, California
   
94063
(Address of principal executive offices)   (Zip Code)
(650) 556-9300
(Registrant’s telephone number,
including area code)
N/A
(Former name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
o     Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o     Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o     Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o     Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240-13e-4(c))
 
 

 


 

Item 2.02 Results of Operations and Financial Condition.
     On May 5, 2009, Genomic Health, Inc. issued a press release announcing financial results for its first fiscal quarter ended March 31, 2009. The full text of the press release is furnished as Exhibit 99.1.
Item 9.01 Financial Statements and Exhibits.
     (d) Exhibits
     
99.1
  Press release issued by Genomic Health, Inc. dated May 5, 2009.

2


 

SIGNATURE
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
     Dated: May 5, 2009
         
  GENOMIC HEALTH, INC.
 
 
  By:   /s/ G. Bradley Cole    
    G. Bradley Cole   
    Chief Operating Officer and Chief Financial Officer   

3


 

         
GENOMIC HEALTH, INC.
EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  Press release issued by Genomic Health, Inc. dated May 5, 2009

4

EX-99.1 2 f52348exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
     
Contacts:

Investors:
Brad Cole
Genomic Health
650-569-2281
investors@genomichealth.com

Media:
Emily Faucette
Genomic Health
415-595-9407
media@genomichealth.com
  (GENOMIC HEALTH LOGO)
Genomic Health Announces First Quarter 2009 Financial Results
and Business Progress
— Product Revenue Increased 43 Percent Compared with 2008 —
— Three Abstracts Accepted for Presentation at the American Society of Clinical Oncology
(ASCO) Annual Meeting, May 29 — June 2, 2009 —
— Conference Call Today at 4:30 p.m. ET —
REDWOOD CITY, Calif. — May 5, 2009 — Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended March 31, 2009.
Total revenue increased to $33.9 million in the first quarter of 2009 compared with $23.4 million in the first quarter of 2008. Product revenue from the Oncotype DX® breast cancer test was $33.4 million in the first quarter of 2009, an increase of 43 percent, compared with $23.3 million in the first quarter of 2008.
Net loss decreased 30 percent to $4.6 million in the first quarter of 2009 from $6.6 million in the first quarter of 2008. Basic and diluted net loss per share was $0.16 in the first quarter of 2009, compared with a net loss per share of $0.24 in the first quarter of 2008.
Cash and cash equivalents and short-term investments at March 31, 2009 were $53.4 million compared with $56.7 million at December 31, 2008.
“Our strong first quarter results, as demonstrated by continued growth in revenues and a reduction in the year-over-year net loss, are a result of our business discipline and focus on making the Oncotype DX breast cancer test standard practice,” said Kim Popovits, President and Chief Executive Officer of Genomic Health. “Looking to the future, we are making significant strides toward becoming a multi-product company. We believe that the positive results from the QUASAR validation study demonstrate the potential of the Oncotype DX platform to deliver clinically important information to physicians and patients with stage II colon cancer.”

 


 

Additional First Quarter 2009 Financial Results
During the first quarter of 2009, approximately 50 percent of product revenue was recorded on an accrual basis and recognized at the time test results were delivered, reflecting established payment patterns from payors with coverage policies or contracts in place.
Total operating expenses were $38.5 million in the first quarter of 2009, compared with $30.6 million for the first quarter of 2008. Included in first quarter 2009 operating expenses were non-cash charges of $4.1 million, including $2.5 million of stock-based compensation expense, compared with $2.3 million of stock-based compensation expense in the same period in 2008, and $1.6 million of depreciation and amortization expenses, compared with $1.0 million of depreciation and amortization expense in the same period in 2008.
Recent Highlights and Accomplishments
Commercial Progress
    Delivered 11,210 test results in the first quarter of 2009, compared with more than 9,150 test results delivered in the first quarter of 2008, an increase of 23 percent year-over-year.
 
    Have now secured coverage for breast cancer patients with lymph node micro-metastases for more than 100 million U.S. insured lives through policies, agreements or contracts with Medicare, Wellpoint, Blue Cross Blue Shield Florida, Blue Cross Blue Shield Michigan and others, bringing the total number of U.S. lives covered for this patient population to over 40 percent.
 
    Established distribution agreements in Brazil and Venezuela.
Product Pipeline
    Announced positive preliminary results of the QUASAR validation study showing that the Oncotype DX colon cancer test met its primary endpoint to predict the likelihood of recurrence for stage II colon cancer patients following surgery and that the colon cancer Recurrence Score® provided additional independent clinical value beyond standard measures of risk. Based on these results, Genomic Health is proceeding with commercialization plans to make the Oncotype DX colon cancer test available to physicians and patients in early 2010.
 
    The QUASAR colon cancer validation study has been accepted for oral presentation at the ASCO annual meeting and full results will be highlighted as a noteworthy abstract in ASCO’s advance presscast on May 14.
    “A quantitative multi-gene RT-PCR assay for prediction of recurrence in stage II colon cancer: Selection of the genes in 4 large studies and results of the independent, prospectively-designed QUASAR validation study.” Oral presentation on Saturday, May 30 (3:00 p.m. ET)
Clinical Progress
    Two breast cancer abstracts were accepted for presentation at the ASCO annual meeting:
    “Genotypic characterization of phenotypically defined triple-negative breast cancer.” Oral presentation on Sunday, May 31 (4:30 p.m. ET)
 
    “Molecular characterization of male breast cancer by standardized quantitative RT-PCR analysis: First large genomic study of 347 male breast cancers compared to 82,434 female breast cancers.” Poster presentation on Monday, June 1 (1-5:00 p.m. ET)

 


 

    Independent researchers presented results of a multi-center Japanese study validating the Oncotype DX Recurrence Score’s ability to predict the likelihood of disease recurrence in Japanese women with estrogen receptor-positive early-stage breast cancer at the 2009 Kyoto Breast Cancer Consensus Conference International Convention in Japan. This was the first study to analyze the utility of the Oncotype DX breast cancer test in a specific ethnic population.
Conference Call Details
To access the live conference call today, May 5, at 4:30 p.m. Eastern Time via phone, please dial (877) 361-8830 from the United States and Canada or +1(706) 679-8297 internationally. The conference ID is 97330922. 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 May 12, and may be accessed by dialing (800) 642-1687 from the United States and Canada or +1(706) 645-9291 internationally. The replay passcode is 97330922.
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, the Oncotype DX® breast cancer test, which has been shown to predict the likelihood of chemotherapy benefit as well as the likelihood of disease recurrence 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 the drivers of the company’s first quarter results; the company’s belief that it is making significant strides toward becoming a multi-product company; the company’s beliefs regarding its Oncotype DX platform; the outcome, success or results of clinical trials; the applicability of clinical study results to actual outcomes; and the company’s intent to commercialize a test for colon cancer and the proposed timing of commercialization. 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 tests; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing tests 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; 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; the applicability of clinical study results to actual outcomes; 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 Annual Report on Form 10-K for the year ended December 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.

 


 

Genomic Health, Inc.
Condensed Consolidated Statements of Operations

(in thousands, except share and per share data)
                 
    For the Three Months Ended
    March 31,
    2009   2008
    (Unaudited)
REVENUES:
               
Product revenues
  $ 33,427     $ 23,356  
Contract revenues
    469       84  
     
Total revenues
    33,896       23,440  
     
 
               
OPERATING EXPENSES:
               
Cost of product revenues
    7,827       5,884  
Research and development
    8,645       6,405  
Selling and marketing
    14,697       12,367  
General and administrative
    7,339       5,906  
     
Total operating expenses
    38,508       30,562  
     
 
               
Loss from operations
    (4,612 )     (7,122 )
     
 
               
Other income (expense):
               
Interest income
    249       621  
Interest and other expense
    (51 )     (133 )
     
Loss before income tax expense
    (4,414 )     (6,634 )
     
 
               
Income tax expense
    (211 )      
     
 
               
Net loss
  $ (4,625 )   $ (6,634 )
     
 
               
Basic and diluted net loss per share
  $ (0.16 )   $ (0.24 )
 
               
Shares used to compute basic and diluted net loss per share
    28,495,955       28,217,160  
     

 


 

Genomic Health, Inc.
Condensed Consolidated Balance Sheets

(in thousands)
                 
    As of     As of  
    31-Mar-09     31-Dec-08  
    (Unaudited)     (Audited)  
Cash and cash equivalents
  $ 10,198     $ 11,171  
Short-term investments
    43,218       45,499  
Accounts receivable, net
    9,115       8,807  
Prepaid expenses and other current assets
    5,842       4,781  
     
Total current assets
    68,373       70,258  
Property and equipment, net
    14,313       15,562  
Restricted cash
    500       500  
Other assets
    364       369  
     
Total assets
  $ 83,550     $ 86,689  
     
 
               
Accounts payable
  $ 2,081     $ 1,898  
Accrued expenses and other current liabilities
    10,695       11,108  
Deferred revenues
    3,329       3,798  
Notes payable, short-term
    1,214       1,814  
Notes payable, long-term
    166       225  
Other liabilities
    1,588       1,671  
Stockholders’ equity
    64,477       66,175  
     
Total liabilities and stockholders’ equity
  $ 83,550     $ 86,689  
     
The condensed consolidated balance sheet at December 31, 2008 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, 2008.
###

 

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-----END PRIVACY-ENHANCED MESSAGE-----