-----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, VDKa6vIL4/k6ieqgoHEgI4X28gZLBABXkO2Ef2pigIAu/A7aLeJivJWwqmJBsRMR 62pVjMgil0sggh6/hS3ltw== 0001144204-10-057609.txt : 20101104 0001144204-10-057609.hdr.sgml : 20101104 20101104160613 ACCESSION NUMBER: 0001144204-10-057609 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101104 DATE AS OF CHANGE: 20101104 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 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-33509 FILM NUMBER: 101164957 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 v200985_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):          November 4, 2010
 
 
RESPONSE GENETICS, INC.
 
 
(Exact name of registrant as specified in its charter)
 
 
Delaware   000-1124608   11-3525548
(State or other   (Commission File   (IRS Employer
jurisdiction of   Number)   Identification No.)
incorporation)
       
 

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)


Not Applicable
(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 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))
 

 
Item 2.02.  Results of Operations and Financial Condition.
 
On November 4, 2010, Response Genetics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2010.  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.

(c) 
Exhibits.
 
Exhibit #
Description
 
99.1*
Copy of the Company’s press release, issued November 4, 2010, as corrected
 
*
Exhibits 99.1 is being furnished to the Securities and Exchange Commission (the “SEC”) pursuant to Item 2.02 and is not being filed with the SEC. Therefore, this exhibit is not incorporated by reference in any of the registrant’s other SEC filings.


 
SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
  RESPONSE GENETICS, INC.  
     
       
Date: November 4, 2010
By:
/s/ Denise McNairn  
    Name: Denise McNairn  
   
Title:   Vice President, General Counsel and Secretary
 
       
 

 
EX-99.1 2 v200985_ex99-1.htm Unassociated Document
 
Exhibit 99.1
 
 
FOR IMMEDIATE RELEASE


Investor Relations Contact:
Media Relations Contact:
Peter Rahmer
Barry Sudbeck
Trout Group
Fleishman-Hillard
646-378-2973
415-318-4261


CORRECTING AND REPLACING
 
Response Genetics, Inc. Reports Third Quarter 2010 Financial Results

LOS ANGELES, November 4, 2010 — Third Quarter Corporate Development Highlights, first bullet, first sentence should read: For the third quarter, total revenue for our ResponseDX™ genetic tests increased 58 percent to $3.0 million (instead For the third quarter, total revenue for our ResponseDX™ genetic tests increased 73 percent to $3.0 million).

The corrected release reads:


Response Genetics, Inc. Reports Third Quarter 2010 Financial Results

LOS ANGELES, November 4, 2010 — Response Genetics Inc. (Nasdaq: RGDX), a company focused on the development and sale of molecular diagnostic tests for cancer, today announced its consolidated financial results for the three and nine months ended September 30, 2010.

“We are successfully executing on our strategy to take market share and expand the sales of our ResponseDX™ genetic tests.  In addition, we are in a great position to take advantage of the increasing market in companion diagnostics,” said Kathleen Danenberg, Response Genetics president and CEO.

Third Quarter Corporate Development Highlights

·  
Expanded Sales and Distribution – For the third quarter, total revenue for our ResponseDX™ genetic tests increased 58 percent to $3.0 million compared to $1.9 million (after adjusting for the one-time increase of $1.5 million resulting from the conversion to the accrual basis of revenue recognition) for the second quarter of 2010.  Gross margin (Total Revenue less Cost of Revenue, as a percentage of Total Revenue) for the third quarter was 51 percent compared to 45 percent for the second quarter of 2010. Average revenue per case (previously described as test) was $1,175 for the third quarter. Total ResponseDX™ genetic tests ordered increased quarter over quarter.  However, now that the Company is on the accrual basis for all ResponseDX sales, the Company will be focusing on total ResponseDX revenue, gross margin and average revenue per case.
 
·  
Publication on ERCC1 and MDR1 Expression in Bladder Cancer – Data from Company sponsored gene expression analysis published in Neoplasia associated high expression of multidrug resistance gene 1 (MDR1) and excision repair cross-complementing 1 (ERCC1) gene expression with inferior outcome after adjuvant chemotherapy in patients with locally advanced bladder cancer. The paper, “MDR1 and ERCC1 Expression Predict Outcome of Patients with Locally Advanced Bladder Cancer Receiving Adjuvant Chemotherapy” (Neoplasia (2010) 12, 628-636), was published online on or about August 5, 2010. The study used quantitative real-time RT-PCR to analyze formalin-fixed paraffin-embedded tumor samples from 108 patients with locally advanced bladder cancer. The Company plans to make available its ResponseDX: Bladder™ test in the future.
 

Third Quarter 2010 Results

Total revenue increased by 147 percent to $5.6 million for the third quarter ended September 30, 2010, compared to $2.3 million for the same period last year. Excluding the net revenue impact of $0.3 million resulting from the conversion to the accrual basis of revenue recognition for ResponseDX private payors, total revenue increased 135 percent to $5.3 million for the quarter ended September 30, 2010, compared to $2.3 million for the same period last year. The increase was primarily due to both an increase in ResponseDX revenues of $2.1 million and $1.2 million increase in pharmaceutical client revenue. Revenue from ResponseDX genetic tests increased by 226 percent to $3.0 million for the third quarter, compared to $0.9 million for the same period in 2009. Excluding the net revenue impact of $0.3 million resulting from the conversion to the accrual basis of revenue recognition for ResponseDX private payors, revenue from ResponseDX genetic tests increased by 198 percent to $2.7 million for the third quarter, compared to $0.9 million for the same period in 2009.  Pharmaceutical client revenue increased 92 percent to $2.6 million, compared to $1.4 million in the third quarter of 2009.

Cost of revenue for the third quarter ended September 30, 2010 was $2.7 million, compared with $1.2 million for the same period ended 2009. Research and development expenses were $0.3 million for the third quarter of 2010, compared with $0.7 million for the same period in the prior year. General and administrative expenses were $2.0 million for the third quarter, compared with $1.3 million for the same period in 2009. Total operating expenses for the third quarter were $6.6 million, compared with $4.2 million for the same period last year. The primary reasons for the increase in total operating expenses are costs related to the continued expansion of the sales force, legal expenses associated with the proxy activities and billing services costs.

Response Genetics’ net loss for the third quarter ended September 30, 2010 was $1.06 million or a loss of $0.06 per share, compared with a net loss of $ 1.97 million, or a loss of $0.14 per share, for the same period last year. Excluding the net revenue impact of $0.3 million resulting from the conversion to the accrual basis for revenue recognition for ResponseDX private payors, the net loss for the three months ended September 30, 2010 was $1.3 million or a loss of $0.07 per share.

 
Nine Months Ended September 30, 2010
 
Total revenue increased by 162 percent to $15 million for the nine months ended September 30, 2010, compared to $5.7 million for the same period last year. Excluding the cumulative net revenue impact of $1.8 million resulting from the conversion from the cash to the accrual basis of revenue recognition for ResponseDX private payors, total revenue increased 131 percent to $13.2 million for the nine months ended September 30, 2010, compared to $5.7 million for the same period last year.  The increase was primarily due to increases in both ResponseDX revenues of $6.6 million and $2.6 million increase in pharmaceutical client revenue. Revenue from ResponseDX genetic tests increased by 406 percent to $8.2 million for the nine months, compared to $1.6 million for the same period in 2009. Excluding the cumulative net revenue impact of $1.8 million resulting from the conversion from the cash to the accrual basis for revenue recognition for ResponseDX private payor revenue, revenue from ResponseDX genetic tests increased by 298 percent to $6.2 million for the nine months, compared to $1.6 million for the same period in 2009. The Company’s pharmaceutical client revenue increased 52 percent to $6.4 million, compared to $4.0 million in the nine months of 2009.

Page 2 of 7

 
Cost of revenue for the nine months ended September 30, 2010 was $7.4 million, compared with $3.9 million for the same period in 2009. Research and development expenses were $1.3 million for the nine months of 2010, compared with $1.7 million for the same period in the prior year. General and administrative expenses were $5.4 million for the nine months of 2010, compared with $4.5 million for the same period in 2009. Total operating expenses for the nine months of 2010 were $18.5 million, compared with $13.3 million for the same period last year. The primary reasons for the increase in total operating expenses were costs related to sales force expansion, increased legal fees associated with the proxy activities and billing services costs.

Response Genetics’ net loss for the nine months ended September 30, 2010 was $3.6 million or a loss of $0.20 per share, compared with a net loss of $7.6 million, or a loss of $0.60 per share, for the same period last year. Excluding the cumulative net revenue impact of $1.8 million resulting from the conversion to the accrual basis of revenue recognition for Response DX private payors, the net loss for the nine months ended September 30, 2010 was $5.3 million or a loss of $0.30 per share.

Cash and Cash Equivalents

Cash and cash equivalents at September 30, 2010, were $5.4 million, compared to $7.1 million at December 31, 2009.


About Response Genetics, Inc.

Response Genetics, Inc. (“RGI”) (the “Company”) (Nasdaq: RGDX) is focused on the development and sale of molecular diagnostic tests for cancer. RGI’s technologies enable extraction and analysis of genetic information from genes derived from tumor samples stored as formalin-fixed and paraffin-embedded specimens. In addition to diagnostic testing services, RGI generates revenue 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 RGI 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 continue to expand its sales of its genetic tests and increase its market share, the potential for using the results of this research to develop diagnostic tests for cancer, the ability of the Company to expand its ResponseDX™ tests , and other statements identified by words such as “projects,” “may,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans” or similar expressions.

Page 3 of 7

 
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.

Page 4 of 7

 
RESPONSE GENETICS, INC.

CONSOLIDATED BALANCE SHEETS

   
December 31,
2009
   
September 30,
2010
 
  
       
(Unaudited)
 
ASSETS
           
Current assets
           
Cash and cash equivalents
 
$
7,058,365
   
$
5,439,211
 
Accounts receivable, net of allowance for doubtful accounts of $21,046 at September 30, 2010
   
1,982,951
     
4,749,177
 
Prepaid expenses and other current assets
   
418,289
     
388,625
 
Total current assets
   
9,459,605
     
10,577,013
 
Property and equipment, net
   
1,253,714
     
1,302,462
 
Other assets
   
79,655
     
 
Total assets
 
$
10,792,974
   
$
11,879,475
 
LIABILITIES, COMMON STOCK CLASSIFED OUTSIDE OF STOCKHOLDERS’ EQUITY (DEFICIT) AND STOCKHOLDERS’ EQUITY (DEFICIT)
               
Current liabilities
               
Accounts payable
 
$
729,100
   
$
1,357,175
 
Accrued expenses
   
503,612
     
640,389
 
Accrued royalties
   
455,995
     
914,477
 
Accrued payroll and related liabilities
   
468,774
     
819,556
 
Deferred revenue
   
2,596,066
     
2,332,725
 
Total current liabilities
   
4,753,547
     
6,064,322
 
                 
Deferred revenue, net of current portion
   
1,414,928
     
354,467
 
Total liabilities
   
6,168,475
     
6,418,789
 
                 
Commitments and contingencies
               
                 
Common stock classified outside of stockholders’ equity (deficit)
   
3,975,279
     
7,854,682
 
                 
Stockholders’ equity (deficit)
               
Common stock, $0.01 par value; 50,000,000 shares authorized; 15,297,183 and 18,316,156  shares issued and outstanding at December 31, 2009 and September 30, 2010, respectively
   
122,393
     
122,529
 
Additional paid-in capital
   
39,858,986
     
40,401,532
 
Accumulated deficit
   
(39,146,784
)
   
(42,728,285)
 
Accumulated other comprehensive loss
   
(185,375
)
   
(189,772)
 
Total stockholders’ equity (deficit)
   
649,220
     
(2,393,996)
 
Total liabilities and stockholders’ equity (deficit)
 
$
10,792,974
   
$
11,879,475
 


Page 5 of 7

 
 

UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
 
   
Three Months
Ended September 30,
   
Nine Months
Ended September 30,
 
  
 
2009
   
2010
   
2009
   
2010
 
Net Revenue
 
$
2,259,523
   
$
5,574,649
   
$
5,694,988
   
$
14,914,212
 
Operating expenses:
                               
Cost of revenue
   
1,161,329
     
2,738,693
     
3,918,311
     
7,392,756
 
Selling and marketing
   
942,795
     
1,554,430
     
2,458,906
     
4,395,400
 
General and administrative
   
1,311,684
     
2,010,855
     
4,501,635
     
5,399,445
 
UK expenses
   
87,785
     
10,799
     
734,284
     
18,190
 
Research and development
   
726,696
     
319,271
     
1,734,223
     
1,279,501
 
Total operating expenses
   
4,230,289
     
6,634,048
     
13,327,177
     
18,485,292
 
Operating loss
   
(1,970,766)
     
(1,059,399)
     
(7,632,189)
     
(3,571,080)
 
Other income (expense):
                               
  Interest expense
   
(2,360)
     
(2,702)
     
(8,199)
     
(7,759)
 
  Interest income
   
256
     
185
     
22,157
     
448
 
  Other
   
     
     
     
(1,854)
 
Loss before provision for income taxes
   
(1,972,870)
     
(1,061,916)
     
(7,618,231)
     
(3,580,245)
 
Provision for income taxes
   
     
     
     
1,256
 
Net loss
 
$
(1,972,870)
   
$
(1,061,916)
   
$
(7,618,231)
   
$
(3,581,501)
 
                                 
Unrealized gain (loss) on foreign currency translation
   
18,467
     
9,045
     
35,708
     
(4,397)
 
Total comprehensive loss
 
$
(1,954,403)
   
$
(1,052,871)
   
 $
(7,582,523)
   
$
(3,585,898)
 
Net loss per share — basic and diluted
 
$
(0.14)
   
$
(0.06)
   
$
(0.60)
   
$
(0.20)
 
Weighted-average shares — basic and diluted
   
14,599,182
     
18,314,379
     
12,594,995
     
17,612,982
 


 
 
 

Page 6 of 7

 
 
 

 
RESPONSE GENETICS, INC.
 
RECONCILING TABLES FOR CASH TO ACCRUAL
 


TABLE ONE

The following details ResponseDX™ revenue for the three and nine months ended September 30, 2009 and 2010:

    Three     Nine  
   
Months ended September 30,
   
Months ended September 30,
 
   
2009
   
2010
   
2009
   
2010
 
Net Medicare revenue
  $ 481,302     $ 1,269,681     $ 819,266     $ 3,159,882  
                                 
Private Payor Revenue through March 31, 2010
          -             1,507,187  
                                 
Private Payor Revenue subsequent to March 31, 2010
          1,690,761             2,638,553  
                                 
Revenue recorded on the cash basis prior to April 1, 2010
    334,926             554,128       717,284  
NeoGenomics Laboratories revenue
    98,421       14,953       250,343       166,464  
                                 
Other
          7,228             24,197  
                                 
Net ResponseDX revenue
  $ 914,649     $ 2,982,623     $ 1,623,737     $ 8,213,567  

TABLE TWO

The following table provides details of ResponseDX™ revenue for the three and nine months ended September 30, 2009 and 2010 based upon the former cash basis revenue recognition policy relating to ResponseDX™ private payors.  This table is presented to provide the amount of revenue recognized if the change to the accrual basis of revenue recognition for ResponseDX™ private payors had not occurred effective April 1, 2010:

    Three     Nine  
   
Months ended September 30,
   
Months ended September 30,
 
   
2009
   
2010
   
2009
   
2010
 
Net Medicare revenue
  $ 481,302     $ 1,269,681     $ 819,266     $ 3,159,882  
                                 
NeoGenomics Laboratories revenue
    98,421       14,953       250,343       166,464  
                                 
Revenue recognized on the former cash basis
    334,926       1,436,406       554,128       3,109,014  
                                 
Other
          7,228             24,197  
                                 
Net ResponseDX revenue
  $ 914,649     $ 2,728,268     $ 1,623,737     $ 6,459,557  


The increase in revenue due to the conversion from cash basis to accrual basis in the three and nine month period ended September 30, 2010 of $254,355 and $1,754,010, respectively, is the difference between the Net ResponseDX™ revenue in Table One and the Net ResponseDX™ revenue in Table Two.


###


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