-----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, LxAmdrkHo57taoDWZozDjxxqlTkVTyxKiiuJjTz94W9+/pIIl3B2WGF68LEhBfXP plZyqcp3KMlyjWSt+cgRDQ== 0000950134-08-019474.txt : 20081105 0000950134-08-019474.hdr.sgml : 20081105 20081105161715 ACCESSION NUMBER: 0000950134-08-019474 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20081105 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081105 DATE AS OF CHANGE: 20081105 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: 081163975 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 f50385e8vk.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): November 5, 2008
GENOMIC HEALTH, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or Other Jurisdiction of
Incorporation)
  000-51541
(Commission File Number)
  77-0552594
(I.R.S. Employer
Identification No.)
     
301 Penobscot Drive
Redwood City, California

(Address of principal executive offices)
  94063
(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 November 5, 2008, Genomic Health, Inc. issued a press release announcing financial results for its third fiscal quarter ended September 30, 2008. 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 November 5, 2008.

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: November 5, 2008
         
  GENOMIC HEALTH, INC.
 
 
  By:   /s/ G. Bradley Cole    
    G. Bradley Cole   
    Executive Vice President and Chief Financial Officer   

3


 

         
GENOMIC HEALTH, INC.
EXHIBIT INDEX
     
Exhibit    
Number   Description
99.1
  Press release issued by Genomic Health, Inc. dated November 5, 2008

4

EX-99.1 2 f50385exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
     
Contacts:

Investors:
Brad Cole
Genomic Health
650-569-2281
investors@genomichealth.com
  (GENOMIC HEALTH LOGO)
 
   
Media:
Emily Faucette
Genomic Health
650-569-2824
media@genomichealth.com
   
Genomic Health Announces Third Quarter 2008 Financial Results and Business Progress
— Product Revenue Increased 78 Percent Compared with 2007—
— Net Loss Narrows —
— Quantitative HER2 Scores Now Included in All Oncotype DX Reports—
— Conference Call Today at 4:30 p.m. ET —
REDWOOD CITY, Calif., November 5, 2008 — Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results and business progress for the quarter ended September 30, 2008.
Total revenue increased to $28.1 million in the third quarter of 2008 compared with $15.9 million in the third quarter of 2007. Product revenue from the Oncotype DX® breast cancer assay was $28.1 million in the third quarter of 2008, an increase of 78 percent, compared with $15.8 million in the third quarter of 2007.
Net loss decreased to $3.0 million in the third quarter of 2008, compared with $7.3 million in the third quarter of 2007. Basic and diluted net loss per share was $0.11 in the third quarter of 2008, compared with a net loss per share of $0.26 in the third quarter of 2007.
Cash and cash equivalents and short-term investments at September 30, 2008 were $54.4 million compared with $60.6 million at June 30, 2008, and $68.4 million at December 31, 2007.
“We believe personalized medicine has the power to improve the quality of care while reducing costs, which is especially important during a time of soaring health care expenses and economic uncertainty,” said Randy Scott, Ph.D., Chairman and Chief Executive Officer of Genomic Health. “This quarter, we again increased the value of Oncotype DX by the inclusion of quantitative HER2 scores, while continuing to invest in our commercial organization here and abroad. We believe the growing use of our Oncotype

 


 

DX breast cancer assay, our narrowing net loss, and our strong balance sheet attest to the strength of our business model as we deliver the promise of genomics into the practice of medicine.”
Additional Third Quarter 2008 Financial Results
The majority of product revenue, approximately 52 percent, was recorded on an accrual basis and recognized at the time the test results were delivered during the third quarter of 2008, reflecting established payment patterns from payors with coverage policies in place.
Total operating expenses were $31.4 million in the third quarter of 2008, compared with $24.0 million for the third quarter of 2007. Included in third quarter 2008 operating expenses were non-cash charges of $3.6 million, including $2.3 million of stock-based compensation expense, compared with $1.6 million in the same period in 2007, and $1.3 million of depreciation and amortization expenses, compared with $1.0 million in the same period in 2007.
Financial Results for Nine Months Ended September 30, 2008
Total revenue for the nine months ended September 30, 2008 was $79.3 million, compared with $44.7 million for the first nine months of 2007. Product revenue for the nine months ended September 30, 2008 was $77.8 million, compared with $43.5 million for the first nine months of 2007. Contract revenue constituted the balance of revenue for the first nine months of 2008 and 2007.
Net loss for the nine months ended September 30, 2008 was $13.8 million, compared with $21.3 million for the first nine months of 2007. Basic and diluted net loss per share was $0.49 for the nine months ended September 30, 2008, compared with a net loss per share of $0.81 for the first nine months of 2007.
Total operating expenses for the nine months ended September 30, 2008 were $94.2 million, compared with $67.6 million for the comparable period in 2007. The increase in expenses includes non-cash charges of $10.5 million, including stock-based compensation expense of $6.9 million in the first nine months of 2008 compared with $4.5 million for the same period in 2007, and $3.6 million of depreciation and amortization expenses, compared with $2.9 million in the same period in 2007.
Recent Highlights and Accomplishments
     Commercial Progress
    More than 10,220 test results delivered in the third quarter of 2008, compared with more than 5,950 test results delivered in the third quarter of 2007, an increase of 72 percent year-over-year.
 
    More than 75,000 Oncotype DX test results have been delivered to patients.
 
    Gained coverage for an additional 7.9 million lives for reimbursement of Oncotype DX through contracts, policies and agreements, bringing the total U.S. covered lives

 


 

      to approximately 89 percent of insured lives including: Coventry Health Care (4.4 million lives), Blue Cross and Blue Shield of Massachusetts (1.3 million lives), Medica Health Plans, HMSA Blue Cross Blue Shield of Hawaii, and WPS Health Insurance in Wisconsin.
    Named a Vice President to oversee European markets.
 
    Established distribution agreements in Australia and Taiwan.
 
    Received test samples from 39 countries to date.
 
    Oncotype DX included in the updated 2008 guidelines of the Dutch Institute for Healthcare Improvement.
     Product Pipeline
    Enhanced clinical utility of Oncotype DX reports by including quantitative HER2 scores; quantitative estrogen receptor and progesterone receptor scores were added earlier this year.
 
    Completed European study using Oncotype DX in node-negative and node-positive breast cancer patients treated with aromatase inhibitors, which was accepted for oral presentation at the San Antonio Breast Cancer Symposium in December 2008.
 
    Continued to make progress toward a clinical validation study in colon cancer, with the goal of reporting results in 2009.
     Peer-Reviewed Publications and Medical Meeting Presentations
    Two abstracts were accepted for oral presentation at the San Antonio Breast Cancer Symposium in December 2008:
    “Risk of distant recurrence using Oncotype DX in postmenopausal primary breast cancer patients treated with anastrozole or tamoxifen: a TransATAC study”
 
    “GRB7-dependent pathways are potential therapeutic targets in triple-negative breast cancer”
    The American Journal of Surgery published results of a study showing Oncotype DX changed treatment recommendations in 44 percent of node-negative, estrogen receptor-positive breast cancer patients.
 
    Presented results from two studies supporting the use of Oncotype DX in assessing HER2 gene expression at the ASCO Breast Cancer Symposium in September.
 
    Independent researchers presented results from a small study of Japanese women demonstrating that the Oncotype DX Recurrence Score® result may predict response to neoadjuvant endocrine therapy including tamoxifen and anastrozole at the ASCO Breast Cancer Symposium in September.

 


 

Conference Call Details
To access the live conference call today, November 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 71000165. 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 November 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 71000165.
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®, 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 beliefs regarding the ability of personalized medicine to improve the quality of healthcare while reducing costs; the components of future growth, if any, in our business; our belief that including quantitative HER2 scores increases the value of Oncotype DX; our beliefs regarding continued investment in our commercial organization domestically and abroad; our beliefs regarding the strengths of our business model; the outcome or success of planned or ongoing clinical trials and our expectations regarding potential clinical outcomes; and the applicability of clinical study results to actual outcomes. 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 or increasing levels of reimbursement for our existing test and any future tests we may develop; our ability to continue to narrow our net loss; 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 June 30, 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   For the Nine Months
    Ended September 30,   Ended September 30,
    2008   2007   2008   2007
         
    (Unaudited)   (Unaudited)
 
                               
REVENUES:
                               
Product revenues
  $ 28,070     $ 15,781     $ 77,752     $ 43,482  
Contract revenues
    51       120       1,592       1,197  
         
Total revenues
    28,121       15,901       79,344       44,679  
         
OPERATING EXPENSES:
                               
Cost of product revenues
    7,140       4,398       19,875       12,417  
Research and development
    6,939       5,643       20,667       16,037  
Selling and marketing
    10,837       9,484       35,030       26,377  
General and administrative
    6,505       4,488       18,635       12,763  
         
Total operating expenses
    31,421       24,013       94,207       67,594  
         
 
                               
Loss from operations
    (3,300 )     (8,112 )     (14,863 )     (22,915 )
 
                               
 
                               
Other income (expense):
                               
Interest income
    369       1,021       1,438       2,149  
Interest and other expense
    (91 )     (162 )     (330 )     (535 )
         
 
                               
Net loss
    ($3,022 )     ($7,253 )     ($13,755 )     ($21,301 )
         
 
                               
Basic and diluted net loss per share
    ($0.11 )     ($0.26 )     ($0.49 )     ($0.81 )
 
                               
Shares used in computing basic and diluted net loss per share
    28,331,505       28,119,786       28,270,776       26,287,177  
         

 


 

Genomic Health, Inc.
Condensed Consolidated Balance Sheets

(in thousands)
                 
    September 30, 2008     December 31, 2007  
    (Unaudited)     (Audited)  
     
Cash and cash equivalents
  $ 9,459     $ 39,164  
Short-term investments
    44,965       29,196  
Accounts receivable, net
    9,423       5,089  
Prepaid expenses and other current assets
    6,013       3,105  
     
Total current assets
    69,860       76,554  
 
               
Property and equipment, net
    14,583       10,412  
Restricted cash
    504       500  
Other assets
    564       463  
     
Total assets
  $ 85,511     $ 87,929  
     
 
               
Accounts payable
  $ 1,448     $ 1,966  
Accrued expenses and other current liabilities
    9,947       7,616  
Deferred revenue
    4,117       1,008  
Notes payable, current
    2,163       2,687  
Notes payable, long-term
    531       2,039  
Other liabilities
    1,814       1,447  
Stockholders’ equity
    65,491       71,166  
     
Total liabilities and stockholders’ equity
  $ 85,511     $ 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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-----END PRIVACY-ENHANCED MESSAGE-----