-----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, Kcv8I9eNrBuqhIkkfaoX+u1E0TEgT+tXLlbDrzUEx3D9oe9iv8dk7UN+EM90NwBA N4jL9Fqb6yqTBtFTIXf31A== 0000950134-06-020310.txt : 20061102 0000950134-06-020310.hdr.sgml : 20061102 20061102161045 ACCESSION NUMBER: 0000950134-06-020310 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20061102 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061102 DATE AS OF CHANGE: 20061102 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: 061182853 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 f24758e8vk.htm FORM 8-K e8vk
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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 2, 2006
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 Number)
     
301 Penobscot Drive
Redwood City, California
  94063
     
     
(Address of principal executive offices)   (Zip Code)
(650) 556-9300
 
(Registrant’s telephone number, including area code)
     Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
  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))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition.
Item 9.01 Financial Statements and Exhibits.
SIGNATURE
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 2.02 Results of Operations and Financial Condition.
     On November 2, 2006, Genomic Health, Inc. issued a press release announcing financial results for its third fiscal quarter ended September 30, 2006. 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 2, 2006.

2


Table of Contents

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 2, 2006
         
  GENOMIC HEALTH, INC.
 
 
  By:             /s/ G. Bradley Cole    
    (signature)   
  Executive Vice President and
Chief Financial Officer
    (title)   
     
     
     
 

3


Table of Contents

EXHIBIT INDEX
     
Exhibit No.   Description
99.1
  Press release issued by Genomic Health, Inc. dated November 2, 2006.

 

EX-99.1 2 f24758exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(GENOMIC HEALTH LOGO)
Contacts:
Brad Cole
Genomic Health, Inc.
650-569-2281
investors@genomichealth.com
Media:
Emily Faucette
WeissComm Partners
415-946-1066
media@genomichealth.com
Genomic Health, Inc. Announces Third Quarter 2006 Financial Results and
Corporate Accomplishments
- Strong Continued Adoption and Reimbursement of Oncotype DX Breast Cancer Test Service -
- Positive Policy Decisions from Aetna and a Number of Regional Payors -
- Five San Antonio Breast Cancer Symposium Abstracts Accepted -
- Conference Call at 4:30 p.m. Eastern Today -
REDWOOD CITY, Calif., November 2, 2006 — Genomic Health, Inc. (Nasdaq: GHDX) today reported financial results for the third quarter and nine months ended September 30, 2006.
Total revenue was $7.1 million in the third quarter of 2006, compared to $1.6 million in the third quarter of 2005. Oncotype DX product revenue was $6.9 million in the third quarter of 2006, compared to $1.4 million in the third quarter of 2005. The remainder in both years consisted of contract revenue from collaborations.
Product revenue from non-Medicare sources was $4.1 million in the third quarter of 2006, up 37 percent compared to the second quarter of 2006. Medicare product revenue was $2.8 million in the third quarter, down, as expected, by approximately $2.0 million from the second quarter of 2006. The second quarter included $2.8 million in retroactive payments from Medicare; excluding these retroactive payments, Medicare revenue in the third quarter was up by $0.8 million, or 40 percent, from the second quarter.
During the third quarter of 2006, approximately 47 percent of product revenue was recorded on an accrual basis and recognized at the time the test service results were delivered, reflecting established payment patterns from payors with coverage policies in place. The balance of product revenue was recognized upon cash collection.

 


 

Cost of product revenue was $2.7 million for the third quarter of 2006, compared to $1.6 million in the third quarter of 2005. Test service volume in the third quarter of 2006 was more than double that of the third quarter of 2005. The cost per test service delivered again decreased in the quarter compared to the comparable period in 2005.
Research and development expenses for the third quarter of 2006 were $3.2 million, compared to $2.3 million in the third quarter of 2005. Selling and marketing, and general and administrative expenses for the third quarter of 2006 were $9.9 million compared to $5.1 million for the third quarter of 2005. The increase in SG&A expense was due to expansion of the sales force, infrastructure to support Oncotype DX and costs associated with being a public company.
The company recorded a net loss of $8.2 million in the third quarter of 2006, compared to a net loss of $7.4 million in the third quarter of 2005.
Basic and diluted net loss per share was $0.33 for the three months ended September 30, 2006 compared to a net loss of $0.39 per share (on a pro forma basis) for the same period in 2005.
“We continue to see solid growth in Oncotype DX adoption and reimbursement,” said Randy Scott, Ph.D., Chairman and Chief Executive Officer of Genomic Health. “The steady increase in adoption underscores the oncology community’s growing support for Oncotype DX and the value we are delivering to both physicians and patients. We are also pleased to see growing support from payors. During the third quarter, Aetna posted a positive policy decision and several regional payors established contracts for Oncotype DX. It is clear that the additional clinical data published in the second quarter, along with growing physician demand, is having a positive impact on our discussions with payors.”
Financial Results for Nine Months Ended September 30, 2006
Total revenue for the nine months ended September 30, 2006 was $20.6 million, compared to $3.3 million for the first nine months of 2005. Product revenue for the nine months ended September 30, 2006 was $18.9 million, compared to $3.0 million for the first nine months of 2005. The company recorded $1.6 million of contract revenue in the nine months ended September 30, 2006 compared to $0.3 million of contract revenue for the first nine months of 2005.
Cost of product revenue for the nine months ended September 30, 2006 was $7.2 million, compared to $4.5 million for the comparable period in 2005. Research and development expenses for the first nine months of 2006 were $8.7 million as compared to $7.0 million in the first nine months of 2005. Selling and marketing, and general and administrative expenses for the first nine months of 2006 were $26.2 million as compared to $15.3 million in the first nine months of 2005.
Net loss for the nine months ended September 30, 2006 was $19.9 million, compared to $23.1 million for the first nine months of 2005.

 


 

Basic and diluted net loss per share was $0.81 for the nine months ended September 30, 2006, compared to a net loss of $1.23 per share (on a pro forma basis) for the same period in 2005.
Cash and cash equivalents at September 30, 2006 were $48.3 million, compared to $69.5 million at December 31, 2005 and $55.1 million at June 30, 2006.
Recent Highlights and Accomplishments
Publications & Scientific Presentations
  Five abstracts (four posters and one oral presentation) regarding Oncotype DX, authored by company researchers and collaborators, have been accepted for the upcoming 29th Annual San Antonio Breast Cancer Symposium, taking place December 14-17, 2006:
  -   A comparison of estrogen receptor (ER) measurement by three methods in node negative, estrogen receptor (ER) positive breast cancer: ligand binding (LB), immunohistochemistry (IHC), and quantitative RT-PCR
(Abstract 3116)
  -   Quantitative RT-PCR analysis of ER and PR by Oncotype DX indicates distinct and different associations with prognosis and prediction of tamoxifen benefit
(Abstract 45, oral presentation)
  -   The impact on the Recurrence Score due to patient variation in the quantitative expression of individual genes or gene groups
(Abstract 6039)
  -   Subtypes of breast cancer defined by standardized quantitative RT-PCR analysis of 10,618 tumors
(Abstract 6118)
  -   Relationship between proliferation genes and expression of hormone and growth factor receptors: quantitative RT-PCR in 10,618 breast cancers
(Abstract 6111)
Physician Adoption
  More than 3,800 test services were delivered in the third quarter of 2006, up 17 percent from the second quarter of 2006, and compared to more than 1,850 test services delivered in the third quarter of 2005. Approximately 19 percent of test services delivered in the third quarter of 2006 were for Medicare patients.
  Over 4,200 physicians have ordered a cumulative total of more than 17,000 test services for their patients.
Reimbursement
  Aetna issued a positive coverage decision. In addition, a number of regional payors have agreed to reimburse for Oncotype DX test services and others have completed favorable technology assessment reviews of Oncotype DX.

 


 

Regulatory
  Genomic Health continues its ongoing dialogue with FDA regarding the Oncotype DX breast cancer assay service. On September 5, 2006 FDA issued draft guidance on “In Vitro Diagnostic Multivariate Index Assays,” which was distributed for public comment purposes only. The company is evaluating the draft guidance and intends to submit comments.
Corporate Development
  A licensing agreement with Pfizer Inc. and Wistar Institute regarding one of the genes in the Oncotype DX 21-gene panel, which is subject to a patent exclusively licensed by a subsidiary of Pfizer, was recently signed, bringing to conclusion a discussion begun in late 2004.
Conference Call Details
To access the live conference call today, November 2 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 9608822. 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 8 and may be accessed by dialing (800) 642-1687 from the United States and Canada or (706) 645-9291internationally. The replay passcode is 9608822.
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. 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. 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 service, Oncotype DX™, which has been shown to predict the likelihood of breast cancer recurrence and the likelihood of chemotherapy benefit in early-stage breast cancer patients. The company was founded in 2000 and is located in Redwood City, California. For more information, please visit 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 continued growth in adoption of and reimbursement for our test service; our belief that the increase in adoption underscores the oncology community’s growing support for our test service and the value it provides to patients and physicians; our belief as to the results published clinical data and growing physician demand is having on our discussions with payors; and our intention to submit comments on FDA’s draft guidance. 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 services; the risk that we may not obtain or maintain sufficient levels of reimbursement for our existing test service and any future services we may develop; the risks and uncertainties associated with the regulation of our test services by FDA; our ability to compete against third parties; our ability to develop and commercialize new test services; 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, 2006. 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 Nine Months  
    Ended September 30,     Ended September 30,  
    2006     2005     2006     2005  
    (Unaudited)     (Unaudited)  
REVENUES:
                               
Product revenues
  $ 6,928     $ 1,375     $ 18,932     $ 2,960  
Contract revenues
    191       216       1,626       316  
         
Total revenues
    7,119       1,591       20,558       3,276  
     
 
                               
OPERATING EXPENSES:
                               
Cost of product revenues
    2,674       1,647       7,201       4,520  
Research and development
    3,229       2,341       8,678       6,971  
Selling and marketing
    6,429       3,390       17,331       10,804  
General and administrative
    3,464       1,724       8,904       4,511  
     
Total operating expenses
    15,796       9,102       42,114       26,806  
         
 
                               
Operating loss
    (8,677 )     (7,511 )     (21,556 )     (23,530 )
         
 
                               
Other income (expense):
                               
Interest income
    594       156       1,932       549  
Interest expense
    (105 )     (91 )     (312 )     (162 )
Other income
    8       0       11       1  
         
 
                               
Net loss
    ($8,180 )     ($7,446 )     ($19,925 )     ($23,142 )
         
 
                               
Basic and diluted net loss per share
    ($0.33 )     ($3.55 )     ($0.81 )     ($11.79 )
 
                               
Shares used to compute basic and diluted net loss per share
    24,516,761       2,095,858       24,499,316       1,963,384  
         
 
                               
Pro forma basic and diluted net loss per share
            ($0.39 )             ($1.23 )
 
                               
Shares used to compute pro forma basic and diluted net loss per share
            18,990,089               18,855,192  
         

 


 

Genomic Health, Inc.
Condensed Consolidated Balance Sheets

(in thousands)
                 
    September 30, 2006     December 31, 2005  
    (Unaudited)     (Audited)  
     
Cash and cash equivalents
  $ 26,565     $ 18,839  
Short term investments
    21,778       50,688  
Accounts receivable
    1,907       314  
Prepaid expenses and other current assets
    2,128       1,621  
     
Total current assets
    52,378       71,462  
 
               
Property and equipment, net
    8,230       3,597  
Restricted cash
    500       500  
Other assets
    151       240  
     
Total assets
  $ 61,259     $ 75,799  
     
 
               
Accounts payable
  $ 1,724     $ 1,393  
Other current liabilities
    4,886       2,978  
Deferred revenue
    1,161       238  
Capital leases, short-term
    1,384       1,052  
Capital leases, long-term
    2,308       2,621  
Stockholder’s equity
    49,796       67,517  
     
Total liabilities and stockholders’ equity
  $ 61,259     $ 75,799  
     
The condensed consolidated balance sheet at December 31, 2005 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, 2005.

 

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