-----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, EpkINPYXS5EeAqDrOetdW76uAfbGxqQpbUVpbZFlHKzBxuKWDBCkugUzAQ83GJqX Ds6JirV2ZuZ+spUcQm8lXg== 0001144204-08-017565.txt : 20080326 0001144204-08-017565.hdr.sgml : 20080326 20080326165804 ACCESSION NUMBER: 0001144204-08-017565 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080326 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080326 DATE AS OF CHANGE: 20080326 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RESPONSE GENETICS INC CENTRAL INDEX KEY: 0001124608 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 000000000 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33509 FILM NUMBER: 08712632 BUSINESS ADDRESS: STREET 1: 1640 MARENGO ST., STREET 2: 6TH FLOOR CITY: LOS ANGELES, STATE: CA ZIP: 90033 BUSINESS PHONE: (323) 224-3900 MAIL ADDRESS: STREET 1: 1640 MARENGO ST., STREET 2: 6TH FLOOR CITY: LOS ANGELES, STATE: CA ZIP: 90033 8-K 1 v108202_8k.htm
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):
March 26, 2008

 
RESPONSE GENETICS, INC.
(Exact name of registrant as specified in its charter)
 
Delaware
 
000-1124608
 
11-3525548
(State or other jurisdiction of
incorporation or organization)
 
(Commission
File Number)
 
(IRS employer
identification no.)
 
1640 Marengo St., 6th Floor
Los Angeles, California 90033
(323) 224-3900
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
 
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 (see General Instruction A.2. below):
 
oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
 
oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
 
oPre-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 March 26, 2008, Response Genetics, Inc., issued a press release announcing its financial results for the fourth quarter and year ended December 31, 2007. The press release is incorporated herein by reference and a copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1.

The information in this Current Report on Form 8-K and the Exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall they be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
 
Item 9.01. Financial Statements and Exhibits.

(d) The following exhibit is furnished with this report:
 
 
Exhibit Number
Description
 
 
99.1
Press Release of Response Genetics, Inc. dated March 26, 2008


 
 

 

SIGNATURES
 
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.
 
 
RESPONSE GENETICS, INC.
 
 
 
 
 
 
Dated: March 26, 2008
By:
/s/ Kathleen Danenberg
 
 
 
Kathleen Danenberg
President & Chief Executive Officer


 
 

 
EX-99.1 2 v108202_ex99-1.htm
 
Exhibit 99.1
 
FOR IMMEDIATE RELEASE  

Investor Relations Contact:
Media Relations Contact:
Peter Rahmer
Camille Payne
Trout Group
Kaleidoscope Marketing Group
415-392-3385
212-284-7669

Response Genetics Reports Full Year 2007 and Fourth Quarter Financial Results
Conference Call Today at 5 p.m. ET

LOS ANGELES, March 26, 2008 -- Response Genetics, Inc. (NASDAQ: RGDX) a company focused on the development of molecular diagnostic tests for cancer, today announced its consolidated financial results for the twelve months ended December 31, 2007 and the fourth quarter of 2007.

“During the fourth quarter of 2007, Response Genetics made great strides to get the ERCC1 test ready for its first quarter 2008 launch,” said Kathleen Danenberg, President and CEO of Response Genetics. “I’m happy to report that not only did we launch ERCC1 in March 2008, but we also expanded our test offerings in the form of ResponseDX: Lung™ and ResponseDX: Colon™, which includes tests for KRAS mutation status, RRM1 gene expression, EGFR amplification, and TS gene expression. The added tests will give both physicians and their patients invaluable information for planning their therapies for non-small cell lung cancer and colorectal cancer. We look forward to expanding the use of ResponseDX tests and further developing our diagnostic pipeline.”

Financial Results for Twelve Months Ended December 31, 2007

Total revenue increased by 30% to $7.8 million in the twelve months ended 2007, compared to $6.0 million in the twelve months of 2006. This increase was primarily generated by the Company's existing pharmaceutical contracts related to pharmacogenomic testing services, and the introduction of new testing services being offered by Response Genetics to its pharmaceutical clients.

Cost of revenue for the twelve months ended in 2007 was $4.0 million compared with $2.5 million for the twelve months of 2006. Research and development expenses were $2.5 million for the twelve months of 2007, compared with $1.3 million for the same period in the prior year. General and administrative expenses were $6.8 million for the twelve months of 2007 compared to $4.0 million for the same period in 2006. Total operating expenses for the twelve months of 2007 increased to $13.3 million, compared with $7.7 million for the same period last year. The increases in operating expenses were primarily due to: (1) non-cash, stock-based compensation to employees and new personnel to support the Company’s growth totaled approximately $2.1 million, (2) operating costs related to the start up and continuing operation of the European laboratory totaled approximately $1.5 million, (3) costs involving the new testing services the Company is offering and additional reagents and supplies totaled approximately $900,000, (4) increases in maintaining the Company’s intellectual property portfolio, costs related to the completion of the Company’s IPO, and costs associated with being a public company, additional depreciation on fixed asset purchases all totaled approximately $1.1 million.


Response Genetics' net loss for the twelve months ended 2007 was $5.5 million or $0.78 per share, compared with a net loss of $2.3 million, or $0.84 per share, for the twelve months of 2006.

Financial Results for the Fourth Quarter Ended December 31, 2007

Total revenue increased by 11% to $2.4 million in the fourth quarter of 2007, compared to $2.2 million in the fourth quarter of 2006. Cost of revenue for the fourth quarter of 2007 was $1,129,473, compared with $834,169 for the fourth quarter of 2006. Research and development expenses were $566,293 for the fourth quarter of 2007, compared with $399,184 for the same period in the prior year. General and administrative expenses of $1.8 million for the fourth quarter of 2007 increased from $1.7 million for the fourth quarter of the prior year. Total operating expenses for the fourth quarter of 2007 increased to $3.5 million, compared with $2.9 million for the same period last year.

Cash and Cash Equivalents

Cash and cash equivalents at December 31, 2007 were $17.0 million compared to $4.9 million at December 31, 2006.

Recent Clinical Development Highlights

In March 2008, Response Genetics, Inc. also expanded its test offerings to include ResponseDX: Lung™ (ERCC1, RRM1, KRAS, EGFR) and ResponseDX: Colon™ (ERCC1, KRAS, TS) to select medical institutions and practice groups through its CLIA-registered laboratory. Response Genetics, Inc. owns multiple patents for the proprietary PCR-based analysis of ERCC1 and TS as biomarkers for platinum-based chemotherapy.

The complete genetic tests offered for patients with NSCLC or CRC comprise:

ERCC1 Gene Expression
Available in ResponseDX: Lung™ and ResponseDX: Colon™: This test measures ERCC1 gene expression, a molecular marker to identify NSCLC and CRC patients who may or may not benefit from platinum-based therapy.

KRAS Mutation Analysis
Available in ResponseDX: Lung™ and ResponseDX: Colon™: This test determines whether or not the K-ras gene (KRAS) contains mutations. A mutated KRAS is a very strong predictor of non-response and no benefit from the epidermal growth factor receptor (EGFR) inhibitors erlotinib and gefitinib.

EGFR Amplification
Available in ResponseDX: Lung™: This test measures the number of copies (gene amplification) of EGFR. A high number of gene copies has been shown to correlate with increased response of NSCLC to the EGFR inhibitors erlotinib and gefitinib.


-more-

RRM1 Gene Expression
Available in ResponseDX: Lung™: This test measures RRM1 gene expression, a molecular marker to identify NSCLC patients who may or may not benefit from chemotherapy regimens that include gemcitabine.

TS Gene Expression
Available in ResponseDX: Colon™: This test determines the level of gene expression of thymidylate synthase (TS) in tumor tissue. TS expression is a predictor of response to fluoropyrimidine-based chemotherapy. 

ResponseDX: Lung™ and ResponseDX: Colon™ are PCR-based tests that help guide therapeutic treatment decisions in patients with non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). All of these tests can be performed on one formalin-fixed paraffin-embedded (FFPE) tumor tissue sample, which eliminates the need for additional tumor samples. The tests are currently in their initial launch phase and are available only to pre-qualified institutions at this time.

During this initial launch, Response Genetics, Inc. is gathering additional data about the utility of these genetic tests, including ERCC1 gene expression, in the treatment of NSCLC and CRC; clinical practice activities such as sample acquisition, logistics, patient and physician communication; and the use of the test in normal clinical practice related to NSCLC and CRC.

Although the focus of Response Genetics, Inc. is currently ResponseDX: Lung™ and ResponseDX: Colon™ the Company continues to move the rest of the diagnostic pipeline along for additional tumor types. Since platinum-based therapies are standard of care for about 500,000 newly diagnosed cancer patients per year in the United States, Response Genetics, Inc. is validating the use of single gene tests in other tumor types such as gastric, ovarian, and esophageal cancers.

To access the teleconference, please follow these instructions.

Teleconference Information:
Toll Free: 1-877-407-8033
International: 1-201-689-8033
Conference ID: 279501

A webcast of this event is available at http://www.investorcalendar.com/IC/CEPage.asp?ID=127528

A replay of this teleconference is available until 4/5/2008. To access the replay, follow these instructions:
 
Toll Free: 1-877-660-6853
International: 1-201-612-7415
Passcodes: Account #: 286 and Conference ID #: 279501

-more-


About Response Genetics, Inc.
 
Response Genetics, Inc. (RGI) (the “Company”) is engaged in the research and development of pharmacogenomic cancer diagnostic tests based on its proprietary and patented technologies. RGI's technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin embedded specimens. RGI currently generates revenue primarily from the sales of its proprietary analytical pharmacogenomic testing services of clinical trial specimens to the pharmaceutical industry. The Company was founded in 1999 and its principal headquarters are located in Los Angeles, California. For more information, please visit www.responsegenetics.com.
 
Forward Looking Statement Notice
 
Except for the historical information contained herein, this press release and the statements of representatives of Response Genetics, Inc. (the "Company") related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company to analyze cancer samples, the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, the ability of the Company to make its ResponseDX: Lung and ResponseDX: Colon tests, including its ERCC-1 molecular diagnostic test available in the first quarter of 2008, or at all, and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions.
 
These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.
 
-more-

RESPONSE GENETICS, INC.
 
CONSOLIDATED BALANCE SHEETS


   
As of December 31, 
 
  
 
  2006
 
2007
 
ASSETS
 
   
 
   
 
Current assets
 
   
 
   
 
Cash and cash equivalents
 
$
4,930,123
 
$
17,024,209
 
Accounts receivable
   
1,288,255
   
4,206,765
 
Prepaid expenses and other current assets
   
837,238
   
562,403
 
Total current assets
   
7,055,616
   
21,793,377
 
Property and equipment, net
   
1,184,963
   
2,593,303
 
Other assets
   
19,102
   
27,353
 
Total assets
 
$
8,259,681
 
$
24,414,033
 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
         
Current liabilities
         
Accounts payable
 
$
404,008
 
$
234,705
 
Accrued expenses
   
547,119
   
305,517
 
Accrued royalties
   
123,852
   
264,551
 
Accrued payroll, bonus and related liabilities
   
595,276
   
521,123
 
Deferred revenue
   
1,628,325
   
7,191,514
 
Total current liabilities
   
3,298,580
   
8,517,410
 
Notes payable to stockholders
   
716,854
   
 
Accrued interest on notes payable to stockholders
   
329,036
   
 
Accrued dividends
   
6,097,579
   
 
Deferred revenue, net of current portion
   
3,320,000
   
790,848
 
Total liabilities
   
13,762,049
   
9,308,258
 
Commitments and contingencies
         
Stockholders’ (deficit) equity
         
Series B Convertible Preferred Stock, $0.01 par value; 1,038,048 and 0 issued and outstanding (liquidation preference of $9 per share, or $9,342,432 plus accrued but unpaid dividends) at December 31, 2006 and December 31, 2007, respectively
   
10,380
   
 
Series A Junior Convertible Preferred Stock, $0.01 par value; 500,000 and 0 issued and outstanding (liquidation preference of $5 per share, or $2,500,000) at December 31, 2006 and December 31, 2007, respectively
   
5,000
   
 
Common stock, $0.01 par value; 20,000,000 and 50,000,000 shares authorized; 2,726,320 and 10,239,276 shares issued and outstanding at December 31, 2006 and December 31, 2007, respectively
   
27,263
   
102,393
 
Additional paid-in capital
   
9,722,273
   
35,356,569
 
Accumulated deficit
   
(15,267,284
)
 
(20,320,191
)
Accumulated other comprehensive loss
   
   
(32,996
)
Total stockholders’ (deficit) equity
   
(5,502,368
)
 
15,105,775
 
Total liabilities and stockholders’ (deficit) equity
 
$
8,259,681
 
$
24,414,033
 
 
-more-

RESPONSE GENETICS, INC.
 
CONSOLIDATED STATEMENTS OF OPERATIONS
 
 
 
 
Three Months
Ended December 31,
 
Years Ended
December 31,
  
 
2006
 
2007
 
2006
 
2007
 
 
 
(Unaudited)
 
 
 
(Unaudited)
 
 
 
 
 
 
 
 
 
Revenue
 
$
2,199,100
 
$
2,434,758
 
$
6,017,025
 
$
7,789,789
 
Operating expenses:
                 
Cost of revenue
   
834,169
   
1,129,473
   
2,456,071
   
4,045,715
 
General and administrative
   
1,699,218
   
1,821,392
   
3,933,660
   
6,786,890
 
Research and development
   
399,184
   
566,293
   
1,261,981
   
2,455,044
 
Total operating expenses
   
2,932,571
   
3,517,158
   
7,651,712
   
13,287,649
 
Operating loss
   
(733,471
)
 
(1,082,400
)
 
(1,634,687
)
 
(5,497,860
)
Other income (expense):
                 
Interest expense
   
(13,590
)
 
(1,815
)
 
(57,537
)
 
(28,669
)
Interest income
   
26,284
   
192,381
   
138,598
   
517,645
 
Other
   
17,783
   
   
196,783
   
 
Loss before income taxes
   
(702,994
)
 
(891,834
)
 
(1,356,843
)
 
(5,008,884
)
Provision for income taxes
   
   
19,722
   
800
   
44,023
 
Net loss
   
(702,994
)
 
(911,556
)
 
(1,357,643
)
 
(5,052,907
)
Preferred stock dividends
   
(233,560
)
 
   
(934,244
)
 
(412,625
)
Net loss attributable to common stockholders
 
$
(936,554
)
$
(911,556
)
$
(2,291,887
)
$
(5,465,532
)
Net loss per share — basic
 
$
(0.34
)
$
(0.09
)
$
(0.84
)
$
(0.78
)
Net loss per share — diluted
 
$
(0.34
)
$
(0.09
)
$
(0.84
)
$
(0.78
)
Weighted-average shares — basic
   
2,726,320
   
10,239,276
   
2,726,320
   
6,987,092
 
Weighted-average shares — diluted
   
2,726,320
   
10,239,276
   
2,726,320
   
6,987,092
 
 
 
###

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