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RESPONSE GENETICS INC 10-Q 2011

Documents found in this filing:

  1. 10-Q
  2. Ex-31.1
  3. Ex-31.2
  4. Ex-32
  5. Ex-32
Unassociated Document
 

 
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 

 
FORM 10-Q
(MARK ONE)

 
x
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended March 31, 2011

 
¨
TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE EXCHANGE ACT

For the transition period from ___________ to __________

Commission file number: 001-33509
 


RESPONSE GENETICS, INC> .
(Exact name of registrant as specified in its charter)

Delaware
11-3525548
(State or other jurisdiction of incorporation or
organization)
(I.R.S. Employer Identification No.)
 
 
1640 Marengo St., 6th Floor, Los Angeles, California
90033
(Address of principal executive offices)
(Zip Code)

(323) 224-3900
(Registrant’s telephone number, including area code)

Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the Registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. Yes x No ¨

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer or a smaller reporting company. See definition of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

Large Accelerated filer ¨
Accelerated filer ¨
Non-accelerated filer ¨
(do not check if a smaller reporting company)
Smaller reporting company x
 
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes ¨ No x

On March 31, 2011, there were 18,361,720 shares of common stock, $.01 par value per share, issued and outstanding.

 
 

 

Response Genetics, Inc.
 
Form 10-Q
Table of Contents

 
 
Page
 
 
 
Number
 
Part I.
Financial Information
 
 
 
 
 
 
 
 
Item 1.
Financial Statements
 
 
 
 
Consolidated Balance Sheets — December 31, 2010 and March 31, 2011 (Unaudited)
 
1
 
 
 
 
 
 
 
Unaudited Consolidated Statements of Operations and Comprehensive Loss — Three months ended March 31, 2010 and 2011
 
2
 
 
 
 
 
 
 
Unaudited Consolidated Statements of Cash Flows —three months ended March 31, 2010 and 2011
 
3
 
 
 
 
 
 
 
Notes to Unaudited Consolidated Financial Statements
 
4 - 19
 
 
 
 
 
 
Item 2.
Management’s Discussion and Analysis of Financial Condition and Results of Operation
 
20
 
 
 
 
 
 
Item 3.
Qualitative and Quantitative Disclosures About Market Risk
 
28
 
 
 
 
 
 
Item 4.
Controls and Procedures
 
28
 
 
 
 
 
 
Part II.
Other Information
 
 
 
 
 
 
 
 
Item 1.
Legal Proceedings
 
28
 
 
 
 
 
 
Item 2.
Unregistered Sales of Equity Securities and Use of Proceeds
 
28
 
 
 
 
 
 
Item 3.
Defaults Upon Senior Securities
 
29
 
 
 
 
 
 
Item 4.
(Removed and Reserved)
 
29
 
 
 
 
 
 
Item 5.
Other Information
 
29
 
 
 
 
 
 
Item 6.
Exhibits
 
29
 
 
 
 
 
 
Signatures
 
30
 
Exhibit Index
 
 
 
 
 
 
 
 
 
EX-31.1 (Certification required under Section 302 of the Sarbanes-Oxley Act of 2002)
 
 
 
 
EX-31.2 (Certification required under Section 302 of the Sarbanes-Oxley Act of 2002)
 
 
 
 
EX-32 (Certification required under Section 906 of the Sarbanes-Oxley Act of 2002)
 
 
 
 
 
ii

 

RESPONSE GENETICS, INC.
 
CONSOLIDATED BALANCE SHEETS

   
December 31,
2010
   
March 31,
2011
 
         
(Unaudited)
 
ASSETS
 
 
 
 
 
 
Current assets
 
 
 
 
 
 
Cash and cash equivalents
 
$
4,120,074
 
 
$
1,924,367
 
Accounts receivable
 
 
4,733,698
 
 
 
6,101,000
 
Prepaid expenses and other current assets
 
 
941,981
 
 
 
611,715
 
Total current assets
 
 
9,795,753
 
 
 
8,637,082
 
Property and equipment, net
 
 
805,817
 
 
 
879,402
 
Total assets
 
$
10,601,570
 
 
$
9,516,484
 
LIABILITIES, COMMON STOCK CLASSIFED OUTSIDE OF STOCKHOLDERS’ EQUITY (DEFICIT) AND STOCKHOLDERS’ EQUITY (DEFICIT)
 
 
 
 
 
 
 
 
Current liabilities
 
 
 
 
 
 
 
 
Accounts payable
 
$
1,247,151
 
 
$
1,026,936
 
Accrued expenses
 
 
1,075,636
 
 
 
477,287
 
Accrued royalties
 
 
809,694
 
 
 
1,066,135
 
Accrued payroll and related liabilities
 
 
1,271,037
 
 
 
1,216,409
 
Deferred revenue
 
 
1,518,696
 
 
 
1,157,008
 
Total current liabilities
 
 
5,922,214
 
 
 
4,943,775
 
 
 
 
 
 
 
 
 
 
Deferred revenue, net of current portion
 
 
100,070
 
 
 
70,487
 
Total liabilities
 
 
6,022,284
 
 
 
5,014,262
 
 
 
 
 
 
 
 
 
 
Commitments and contingencies
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Common stock classified outside of stockholders’ equity (deficit)
 
 
7,854,682
 
 
 
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, 2010 and March 31, 2011, respectively
 
 
122,942
 
 
 
122,529
 
Additional paid-in capital
 
 
40,612,785
 
 
 
40,824,815
 
Accumulated deficit
 
 
(43,817,163
)
 
 
(44,074,053
)
Accumulated other comprehensive loss
 
 
(193,960
)
 
 
(225,751
)
Total stockholders’ equity (deficit)
 
 
(3,275,396
)
 
 
(3,352,460
)
Total liabilities and stockholders’ equity (deficit)
 
$
10,601,570
 
 
$
9,516,484
 
 
The accompanying notes are an integral part of these consolidated financial statements.

 
1

 

RESPONSE GENETICS, INC.
 
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
 
   
Three Months
Ended March 31
 
 
 
2010
 
 
2011
 
Net Revenue
 
$
3,696,908
 
 
$
5,927,575
 
Operating expenses:
 
 
 
 
 
 
 
 
Cost of revenue
 
 
2,133,808
 
 
 
2,700,922
 
Selling and marketing
 
 
1,415,871
 
 
 
1,439,125
 
General and administrative
 
 
1,662,713
 
 
 
1,877,346
 
Research and development
 
 
572,184
 
 
 
164,342
 
Total operating expenses
 
 
5,784,576
 
 
 
6,181,735
 
Operating loss
 
 
(2,087,668
)
 
 
(254,160
)
Other income (expense):
 
 
 
 
 
 
 
 
Interest expense
 
 
(3,866
)
 
 
(2,783
)
Interest income
 
 
99
 
 
 
52
 
Other
 
 
(1,854
)
 
 
 
Loss before provision for income taxes
 
 
(2,093,289
)
 
 
(256,891
)
Provision for income taxes
 
 
1,256
 
 
 
 
Net loss
 
$
(2,094,545
)
 
$
(256,891
)
 
 
 
 
 
 
 
 
 
Unrealized gain (loss) on foreign currency translation
 
 
(12,421
)
 
 
(42,778
)
Total comprehensive loss
 
$
(2,106,966
 
$
(299,669
)
Net loss per share — basic and diluted
 
$
(0.13
)
 
$
(0.01
)
Weighted-average shares — basic and diluted
 
 
16,198,788
 
 
 
18,358,892
 
 
The accompanying notes are an integral part of these consolidated financial statements.

 
2

 

RESPONSE GENETICS, INC.
 
UNAUDITED CONSOLIDATED STATEMENTS OF CASH FLOWS

   
Three Months
Ended March 31,
 
 
 
2010
 
 
2011
 
Cash flows from operating activities:
 
 
 
 
 
 
Net loss
 
$
(2,094,545
)
 
$
(256,891
)
Adjustments to reconcile net loss to net cash used in operating activities:
 
 
 
 
 
 
 
 
Depreciation and amortization
 
 
82,527
 
 
 
99,000
 
Share-based compensation
 
 
119,146
 
 
 
206,206
 
Bad debt expense
 
 
104,414
 
 
 
140,218
 
Loss on sale of property and equipment
 
 
1,854
 
 
 
 
Changes in operating assets and liabilities:
 
 
 
 
 
 
 
 
Accounts receivable
 
 
(607,595
)
 
 
(1,507,520
)
Prepaid expenses and other current assets
 
 
(43,373
)
 
 
330,265
 
Accounts payable
 
 
277,042
 
 
 
(220,215
)
Accrued expenses
 
 
235,074
 
 
 
(598,349
)
Accrued royalties
 
 
122,201
 
 
 
256,441
 
Accrued payroll and related liabilities
 
 
410,084
 
 
 
(54,627
)
Deferred revenue
 
 
(344,777
)
 
 
(391,271
)
Net cash used in operating activities
 
 
(1,737,948
)
 
 
(1,996,743
)
Cash flows from investing activities:
 
 
 
 
 
 
 
 
Purchases of property and equipment
 
 
(96,153
)
 
 
(172,585
)
Cash flows from financing activities:
 
 
 
 
 
 
 
 
Net proceeds from issuance of common stock
 
 
3,879,403
 
 
 
 
Proceeds on exercise of stock options
 
 
 
 
 
5,411
 
Net cash provided by financing activities
 
 
3,879,403
 
 
 
5,411
 
Effect of foreign exchange rates on cash and cash equivalents
 
 
(12,421
)
 
 
(31,790
)
Net increase (decrease) in cash and cash equivalents
 
 
2,032,881
 
 
 
(2,195,707
)
Cash and cash equivalents:
 
 
 
 
 
 
 
 
Beginning of period
 
 
7,058,365
 
 
 
4,120,074
 
End of period
 
$
9,091,246
 
 
$
1,924,367
 
Cash paid during the period for:
 
 
 
 
 
 
 
 
Income taxes
 
$
 
 
$
 
Interest
 
$
3,866
 
 
$
2,783
 
 
The accompanying notes are an integral part of these consolidated financial statements.

 
3

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
1. Organization, Operations and Basis of Accounting
 
Response Genetics, Inc. (the “Company”) was incorporated in the state of Delaware on September 23, 1999 as Bio Type, Inc. for the purpose of providing unique molecular profiling services of tumor tissue that has been formalin-fixed and embedded in paraffin wax. In August 2000, the Company changed its name to Response Genetics, Inc.
 
The Company is a life science company engaged in the research, development, marketing and sale of pharmacogenomic tests for use in the treatment of cancer. Pharmacogenomics is the science of how an individual’s genetic makeup relates to drug response. Tests based on pharmacogenomics facilitate the prediction of a response to drug therapy or survival following surgery based on an individual’s genetic makeup. In order to generate pharmacogenomic information from patient specimens for these tests, the Company developed and patented enabling methods for maximizing the extraction and analysis of nucleic acids and, therefore, accessing the genetic information available from each patient sample. The Company’s platforms include analysis of single biomarkers using the polymerase chain reaction method as well as global gene interrogation using microarray methods from paraffin or frozen tissue specimens. The Company primarily derives its revenue from the sale of its ResponseDX™ diagnostic testing products and by providing pharmacogenomic testing services to pharmaceutical companies in the United States, Asia and Europe.
 
The Company’s goal is to provide cancer patients and their physicians with a means to make informed, individualized treatment decisions based on genetic analysis of tumor tissues. The Company’s pharmacogenomic analysis of clinical trial specimens for the pharmaceutical industry may provide data that will lead to a better understanding of the molecular basis for response to specific drugs and, therefore lead to individualized treatment.
 
Since its inception, the Company has devoted substantial effort in developing its product and has incurred losses and negative cash flows from operations, and March 31, 2011 has an accumulated deficit of $44,074,053. The Company is forecasting continued losses and negative cash flows as it funds its selling and marketing activities and research and development programs.
 
Based on the Company’s current operating plan which includes various assumptions concerning the level and timing of cash receipts from product sales and cash outlays for operating expenses and capital expenditures, management believes that existing cash and cash equivalents will be sufficient to meet the Company’s working capital requirements through the next twelve months. The Company’s ability to successfully carry out its business plan is primarily dependent upon its ability to (1) obtain sufficient additional capital at acceptable costs, (2) attract and retain knowledgeable workers, and (3) generate significant revenues. The Company plans to seek additional financing and/or strategic investments; however, there can be no assurance that any additional financing or strategic investments will be available on acceptable terms, if at all.
 
However, if events or circumstances occur such that the Company does not meet its operating plan as expected, in addition to seeking the additional capital as described above, the Company will most likely be required to reduce certain discretionary spending, which could have a material adverse effect on the Company’s ability to achieve its intended business objectives. No adjustments have been made to the accompanying financial statements to reflect any of the matters discussed above. The consolidated financial statements have been prepared on the basis that the Company will continue as a going concern.
 
The accompanying unaudited consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information and with the instructions for Form 10-Q promulgated by the Securities and Exchange Commission (the “SEC”). Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. The results of operations for interim periods are not necessarily indicative of the results that may be expected for the fiscal year. The financial statements should be read in conjunction with the Company’s audited December 31, 2009 and 2010 consolidated financial statements and accompanying notes included in the Company’s Form 10-K and 10-KA previously filed with the SEC.
 
2. Summary of Significant Accounting Policies>
 
Basis of Consolidation
 
The consolidated financial statements include the accounts of Response Genetics, Inc. and its wholly owned subsidiary, Response Genetics, Ltd., a Scottish corporation, which was incorporated in November 2006. All significant intercompany transactions and balances have been eliminated in consolidation.

Cash and Cash Equivalents
 
The Company considers all highly liquid investments with a maturity at date of purchase of three months or less to be cash equivalents. The carrying value of cash equivalents approximates fair value due to the short-term nature and liquidity of these instruments. The Company’s cash equivalents are comprised of cash on hand, deposits in banks and money market investments.

 
4

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
2. Summary of Significant Accounting Policies - (continued)
 
Accounts Receivable>
 
Clinical Accounts Receivable
 
The Company invoices its clients as specimens are processed and any other contractual obligations are met. The Company’s contracts with clients typically require payment within 45 days of the date of invoice. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its clients to make required payments. The Company specifically analyzes accounts receivable and historical bad debts, client credit, current economic trends and changes in client payment trends when evaluating the adequacy of the allowance for doubtful accounts. Account balances are charged-off against the allowance when it is probable the receivable will not be recovered. To date, the Company’s clients have primarily been large pharmaceutical companies. As a result, bad debts to date have been minimal. Pharmaceutical company accounts receivable as of December 31, 2010 and March 31, 2011 were $1,694,130 and $3,017,360, respectively. There were no allowances for doubtful accounts recorded against these accounts receivable at December 31, 2010 and March 31, 2011.
 
ResponseDX Accounts Receivable
 
Response DX accounts receivable are recorded from three primary payors: Medicare, third party and private payors (Private Payors), based upon their respective applicable billing rates. ResponseDX accounts receivable related to Medicare are recorded at established billing rates less an estimated billing adjustment, based on reporting models utilizing historical cash collection percentages and updated for current effective reimbursement factors. Beginning with the second quarter of 2010, as discussed in our Revenue Recognition accounting policy, ResponseDX accounts receivable related to Private Payors are recorded at established billing rates less an estimated billing adjustment reflecting historical collections patterns. Prior to the quarter ended June 30, 2010, the Company did not record accounts receivable related to Private Payors as the related revenue was recorded on a cash basis. Management performs ongoing valuations of accounts receivable balances based on management’s evaluation of historical collection experience and industry trends. Based on the historical experience for our Medicare accounts, management has determined that billings over one year are unlikely to be collected. The Company has not recorded an allowance for doubtful accounts of March 31, 2011. During the three months ended March 31, 2010 and March 31, 2011, the Company recorded bad debt expense of $104,414 and $140,218.
 
ResponseDX accounts receivable as of December 31, 2010 and March 30, 2011, consisted of the following:

   
December
31,
2010
   
March 31,
2011
 
 
 
 
 
 
(Unaudited)
 
Net Medicare receivable
 
$
1,092,386
 
 
$
856,596
 
Net Private Payor receivable for ResponseDX revenues from April 1, 2010 to March 31, 2011
 
 
1,726,154
 
 
 
2,221,756
 
Net Private Payor receivable for ResponseDX revenues through March 31, 2010
 
 
334,866
 
 
 
 
Other
 
 
 
 
 
5,288
 
 
 
 
3,153,406
 
 
 
3,083,640
 
Allowance for doubtful accounts - Medicare
 
 
(113,838
)
 
 
 
Net ResponseDX accounts receivable
 
$
3,039,568
 
 
$
3,083,640
 
 
The receivable for Medicare is net of contractual allowances. The receivables for Private Payors are net of an allowance to reflect the estimated collection percentage established from historical collection data.

 
5

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
2. Summary of Significant Accounting Policies - (continued)
 
Property and Equipment>
 
Property and equipment are carried at cost less accumulated depreciation and amortization. Depreciation and amortization are calculated using the double declining balance and straight-line methods over the estimated useful lives of the assets. The Company has determined the estimated useful lives of its property and equipment, as follows:
 
Laboratory equipment
 
5 to 7 years
Furniture and Equipment
 
5 to 7 years
Leasehold Improvements
 
Shorter of the useful life or the lease term (5 to 7 years)
 
Maintenance and repairs are charged to expense as incurred. The cost and accumulated depreciation of assets sold or otherwise disposed of are removed from the related accounts and the resulting gain or loss is reflected in the statements of operations. As of December 31, 2010 and March 31, 2011, the Company has capitalized costs related to database software development (see Note 3). The Company has not yet placed this database into service and accordingly has not depreciated this software development cost. The Company intends to place this database software cost into service in 2011 and begin amortizing those costs in accordance with ASC 350-40, Internal-Use Software , (formerly SOP 98-1). The amortization period will be three years using the straight line method.

Revenue Recognition
 
Pharmacogenomic Revenue
 
Revenues that are derived from pharmacogenomic testing services provided to pharmaceutical companies are recognized on a contract specific basis pursuant to the terms of the related agreements. Revenue is recognized in accordance with ASC 605, Revenue Recognition, which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence of an arrangement exists; (2) delivery has occurred and title and the risks and rewards of ownership have been transferred to the client or services have been rendered; (3) the price is fixed or determinable; and (4) collectability is reasonably assured.
 
Revenues are recorded on an accrual basis as the contractual obligations are completed and as a set of assays is processed through the Company’s laboratory under a specified contractual protocol and are recorded on the date the tests are resulted. Certain contracts have minimum assay requirements that, if not met, result in payments that are due upon the completion of the designated period. In these cases, revenues are recognized when the end of the specified contract period is reached.
 
On occasion, the Company may enter into a contract that requires the client to provide an advance payment for specimens that will be processed at a later date. In these cases, the Company records this advance as deferred revenue and recognizes the revenue as the specimens are processed or at the end of the contract period, as appropriate.
 
ResponseDX Revenue
 
Effective April 1, 2010, the Company recognizes all product revenue from its ResponseDX tests on an accrual basis. Through March 31, 2010, the Company recognized revenue from Private Payors on a cash basis as the Company had not, until then, established a collection history. As of April 1, 2010, a pattern of collections had beenestablished and the Company began to record revenues from Private Payors of ResponseDX on an accrual basis.

 
6

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

2. Summary of Significant Accounting Policies - (continued)

Revenue Recognition – (continued)
 
For accounting purposes, the change from the cash basis to the accrual basis of recording revenue for ResponseDX tests paid by Private Payors, is considered a change in accounting estimate leading to a change in accounting principle. The change in accounting estimate was derived from the establishment of a reasonable basis to estimate the amount to be collected from certain Private Payors. This change in estimate resulted in the change in accounting principle from the cash basis to the accrual basis of revenue recognition for ResponseDX tests paid by Private Payors. Accordingly, the Company has recorded in the second quarter of 2010 a one-time adjustment to increase revenue by $1,507,187, which represents the amount of ResponseDX tests completed in prior periods for which cash payment under the former revenue recognition method had not been received as of April 1, 2010. Since all sales of Response DX tests are on the accrual basis from April 1, 2010, the Company does not expect any such future one-time adjustments to revenue. The revenue recorded from ResponseDX sales to Private Payors for the three months ended March 31, 2010 and March 31, 2011 was $1,720,250 and $3,100,273, respectively. As a result of the conversion from the cash basis to the accrual basis of recording revenue for ResponseDX tests paid by Private Payors, the Company recognized a total of $164,833 more in revenue during the three months ended March 31, 2011, respectively, than it would have recognized had the Company continued to recognize such amounts on the cash basis during this same period.
 
The Company has received its Medicare provider number which allows it to invoice and collect from Medicare. Invoicing to Medicare is primarily based on amounts allowed by Medicare for the service provided as defined by Common Procedural Terminology (CPT) codes. ResponseDX revenues related to Medicare billings are recorded at established billing rates net of an estimated billing adjustment, based on reporting models utilizing historical cash collection percentages and updated for current effective reimbursement factors. Response DX revenue related to Private Payors are recorded at established billing rates less an allowance to reflect the revenue at the amounts expected based on historical collections patterns.
 
The following details ResponseDX revenue for the three months ended March 31, 2010 and 2011:

   
Three Months
 
   
Ended March 31,
 
   
(Unaudited)
 
 
 
2010
 
 
2011
 
 
 
 
 
 
 
 
Net Medicare revenue
 
$
906,785
 
 
$
1,148,963
 
 
 
 
 
 
 
 
 
 
Private Payor revenue through March 31, 2011
 
 
 
 
 
1,951,310
 
 
 
 
 
 
 
 
 
 
Revenue recorded on the cash basis prior to April 1, 2010
 
 
717,284
 
 
 
 
 
 
 
 
 
 
 
 
 
NeoGenomics Laboratories revenue
 
 
90,685
 
 
 
 
 
 
 
 
 
 
 
 
 
Other
 
 
5,496
 
 
 
 
 
 
 
 
 
 
 
 
 
Net ResponseDX revenue
 
$
1,720,250
 
 
$
3,100,273
 
 
 
7

 

2. Summary of Significant Accounting Policies - (continued)
 
Revenue Recognition – (continued)
 
The following table provides details of ResponseDX revenue for the three months ended March 31, 2010 and 2011 based upon the former cash basis revenue recognition policy relating to Private Payors. This table is presented to provide the amount of revenue recognized if the change to the accrual basis of revenue recognition for Private Payors had not occurred effective April 1, 2010:

   
Three Months
 
   
Ended March 31,
 
   
(Unaudited)
 
 
 
2010
 
 
2011
 
 
 
 
 
 
 
 
Net Medicare revenue
 
$
906,785
 
 
$
1,305,883
 
 
 
 
 
 
 
 
 
 
Neogenomics Laboratories revenue
 
 
90,685
 
 
 
 
 
 
 
 
 
 
 
 
 
Revenue recognized on the cash basis
 
 
717,284
 
 
 
1,629,557
 
 
 
 
 
 
 
 
 
 
Other
 
 
5,496
 
 
 
 
 
 
 
 
 
 
 
 
 
Net ResponseDX revenue
 
$
1,720,250
 
 
$
2,935,440
 
 
Cost-Containment Measures
 
Both government and private pay sources have instituted cost-containment measures designed to limit payments made to providers of health care services, and there can be no assurance that future measures designed to limit payments made to providers will not adversely affect the Company.
 
Regulatory Matters
 
Laws and regulations governing Medicare programs are complex and subject to interpretation. Compliance with such laws and regulations can be subject to future governmental review and interpretation, as well as significant regulatory action including fines, penalties and exclusions from certain governmental programs. The Company believes that it is in compliance with all applicable laws and regulations and is not aware of any pending or threatened investigations involving allegations of potential wrongdoing.
 
A portion of the Company’s revenues are derived from Medicare for which reimbursement rates are subject to regulatory changes and government funding restrictions. Although the Company is not aware of any significant future rate changes, significant changes to the reimbursement rates could have a material effect on the Company’s operations.
 
Cost of Revenue
 
Cost of revenue represents the cost of materials, direct labor, costs associated with processing tissue specimens including pathological review, staining, microdissection, paraffin extraction, reverse transcription polymerase chain reaction, or (“RT-PCR”) and quality control analyses, license fees and delivery charges necessary to render an individualized test result. Costs associated with performing tests are recorded as the tests are processed. Costs of revenue associated with the Private Payor revenue recognized as of April 1, 2010, were incurred and expensed in prior periods.
 
License Fees
 
The Company has licensed technology for the extraction of mRNA from formalin-fixed, paraffin-embedded tumor specimens from the University of Southern California (“USC”). Under the terms of the license agreement, the Company is required to pay royalties to USC based on the revenue generated by use of this technology. The Company maintains a non-exclusive license to use the polymerase chain reaction (“PCR”), homogenous PCR, and reverse transcription PCR processes of Roche Molecular Systems, Inc. (“Roche”). The Company pays Roche Molecular Systems a royalty fee based on revenue that the Company generates through use of this technology. The Company accrues for such royalties at the time revenue is recognized. Such royalties are included in cost of revenues in the accompanying statements of operations.

 
8

 

2. Summary of Significant Accounting Policies - (continued)
 
Research and Development
 
The Company expenses costs associated with research and development activities as incurred. Research and development costs are allocated on a pro rata basis using the number of research-only specimens that are processed by the Company versus specimens that are processed and paid for by various third parties via contract. Research and development costs include employee costs (salaries, payroll taxes, benefits, and travel), equipment depreciation and warranties and maintenance, laboratory supplies, primers and probes, reagents, patent costs and occupancy costs.
 
Income Taxes
 
Deferred tax assets and liabilities are determined based on differences between the financial reporting and tax basis of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. Valuation allowances are established when necessary to reduce deferred tax assets to the amount expected to be realized.
 
ASC 740, Income Taxes, clarifies the accounting for uncertainty in income taxes recognized in financial statements and requires the impact of a tax position to be recognized in the financial statements if that position is more likely than not of being sustained by the taxing authority. As of December 31, 2010 and March 31, 2011, the Company does not have a liability for unrecognized tax benefits. The Company recognizes interest and penalties associated with tax matters as part of the income tax provision and includes accrued interest and penalties with the related tax liability in the balance sheet.
 
Stock-Based Compensation
 
The Company accounts for stock-based compensation in accordance with ASC 718, Stock Compensation (formerly SFAS 123(R), Share-Based Payment). Stock-based compensation expense for all stock-based compensation awards granted is based on the grant-date fair value estimated in accordance with the provisions of ASC 718. The Company recognizes these compensation costs on a straight-line basis over the requisite service period of the award, which is generally the option vesting term of three to four years
 
The Company accounts for equity instruments issued to non-employees in accordance with ASC 505, Equity, (formerly EITF 96-18 – Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services). Under ASC 505, stock option awards issued to non-employees are measured at fair value using the Black-Scholes option-pricing model and recognized pursuant to a performance model.
 
Management Estimates
 
The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ materially from those estimates.
 
Long-lived Assets
 
Long-lived assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates potential impairment by comparing the carrying amount of the asset with the estimated undiscounted future cash flows associated with the use of the asset and its eventual disposition. Should the review indicate that the asset is not recoverable, the Company’s carrying value of the asset would be reduced to its estimated fair value, which is measured by future discounted cash flows.
 
Foreign Currency Translation
 
The financial position and results of operations of the Company’s foreign operations are determined using local currency as the functional currency. Assets and liabilities of these operations are translated at the exchange rate in effect at each period-end. Statement of operations amounts are translated at the average rate of exchange prevailing during the period. Translation adjustments arising from the use of differing exchange rates from period to period are included in accumulated other comprehensive loss in stockholders’ equity (deficit). The Company accounts for deferred revenue related to a specific contract as a nonmonetary obligation using historical exchange rates.
 
Comprehensive Loss
 
Comprehensive loss encompasses the change in equity from transactions and other events and circumstances from non-owner sources and the Company’s net loss. The components of comprehensive loss and accumulated other comprehensive loss comprise net loss and foreign currency translation adjustments as of December 31, 2010 and March 31, 2011, and for the three months ended March 31, 2010 and 2011.
 
Fair Value of Financial Instruments
 
Cash and cash equivalents are stated at cost, which approximates fair market value. Cash equivalents consist of money market accounts, with fair values estimated based on quoted market prices. For additional information see Note 14.
 
Selling and Marketing Costs>
 
The Company markets its services through its advertising activities in trade publications and on line. Advertising costs are included in selling and marketing expenses on the statements of operations and are expensed as incurred. Advertising costs for the three months ended March 31, 2010 and 2011 were $146,301 and $49,882, respectively.
 
Reclassifications>
 
Prior year amounts in the consolidated financial statements have been reclassified to conform with the current year presentation. Reclassified amounts had no impact on the company’s net losses.

 
9

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
2. Summary of Significant Accounting Policies - (continued)
 
Concentration of Credit Risk and Clients and Limited Suppliers>
 
Cash and cash equivalents are maintained at financial institutions and, at times, balances may exceed federally insured limits. We have never experienced any losses related to these balances. All of our non-interest bearing cash balances were fully insured at March 31, 2011 due to a temporary federal program in effect from December 31, 2010 through December 31, 2012. Under the program, there is no limit to the amount of insurance for eligible accounts. Beginning 2013, insurance coverage will revert to $250,000 per depositor at each financial institution, and our non-interest bearing cash balances may again exceed federally insured limits. In addition, the Company has invested its excess cash in money market instruments which are not insured under the Federal Deposit Insurance Corporation but are insured under the Securities Industry Protection Corporation. At March 31, 2011, the Company had $1,600,885 of cash in money market instruments and has not incurred any losses on these cash balances. At March 31, 2011, $184,102 of cash was held outside of the United States and is uninsured.
 
Revenue sources that account for greater than 10 percent of total revenue are provided below.
 
   
Three Months 
Ended March 31,
 
   
2010
   
2011
 
   
(Unaudited)
 
   
Revenue
   
Percent
of Total
Revenue
   
Revenue
   
Percent
of Total
Revenue
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GlaxoSmithKline and GlaxoSmithKline Biologicals
 
$
1,573,434
 
 
 
43
%
 
$
2,500,689
 
 
 
42
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medicare, net of contractual allowances
 
$
906,785
 
 
 
14
%
 
$
1,148,963
 
 
 
19
%
 
Customers that account for greater than 10 percent of accounts receivable are provided below.

   
As of December 31, 2010
   
As of March 31, 2011
 
         
(Unaudited)
 
   
Receivable
Balance
   
Percent of
Total
Receivables
   
Receivable
Balance
   
Percent of
Total
Receivables
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
GlaxoSmithKline and GlaxoSmithKline Biologicals
 
$
1,305,829
 
 
 
28
%
 
$
2,926,630
 
 
 
48
%
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Medicare, net of contractual allowances
 
$
1,092,386
 
 
 
23
%
 
$
856,597
 
 
 
14
%
 
Many of the supplies and reagents used in the Company’s testing process are procured by a limited number of suppliers. Any supply interruption or an increase in demand beyond the suppliers’ capabilities could have an adverse impact on the Company’s business. Management believes it can identify alternative sources, if necessary, but it is possible such sources may not be identified in sufficient time to avoid an adverse impact on its business. Refer also to Note 6 for further discussion regarding these supply agreements. The Company purchases certain laboratory supplies and reagents primarily from two suppliers. Purchases from the top two of those companies accounted for approximately 57% and 82% of the Company’s reagent purchases for the three months ended March 31, 2010 and 2011, respectively.

 
10

 
 
RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

2. Summary of Significant Accounting Policies - (continued)

Recent Accounting Pronouncements

In January 2010, the FASB issued ASU 2010-06, Improving Disclosures about Fair Value Measurements, amends FASB ASC 820-10, Fair Value Measurements and Disclosures, and requires new disclosures about transfers into and out of Level 1 and 2 of the fair value hierarchy and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurements.  It is effective for interim and annual reporting periods beginning after December 15, 2009, except for the Level 3 measurement disclosures, which are effective for fiscal years beginning after December 15, 2010, and for interim periods within those fiscal years.  Early adoption is permitted. The adoption of this guidance did not have a material effect on our results of operations or financial position.

In April 2010, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2010-17, “Revenue Recognition — Milestone Method (Topic 605): Milestone Method of Revenue Recognition”. This ASU provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition. Consideration that is contingent on achievement of a milestone in its entirety may be recognized as revenue in the period in which the milestone is achieved only if the milestone is judged to meet certain criteria to be considered substantive. The updated guidance is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Entities may elect to adopt the amendments in the ASU retrospectively for all prior periods. The Company does not expect the adoption of these provisions to have a material effect on its consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, Revenue Recognition (Topic 605)—Multiple-Deliverable Revenue Arrangements: a consensus of the FASB Emerging Issues Task Force (ASU 2009-13). ASU 2009-13 establishes a selling-price hierarchy for determining the selling price of each element within a multiple-deliverable arrangement. Specifically, the selling price assigned to each deliverable is to be based on vendor-specific objective evidence (VSOE) if available, third-party evidence, if VSOE is unavailable, and estimated selling prices if neither VSOE or third-party evidence is available. In addition, ASU 2009-13 eliminates the residual method of allocating arrangement consideration and instead requires allocation using the relative selling price method. ASU 2009-13 will be effective prospectively for multiple-deliverable revenue arrangements entered into, or materially modified, in fiscal years beginning on or after June 15, 2010. The adoption of this guidance did not have a material effect on our results of operation or financial position.

3. Property and Equipment
 
Property and equipment consists of the following:
 
   
December 31,
2010
   
March 31,
2011
 
         
(Unaudited)
 
Laboratory equipment
  $ 2,389,339     $ 2,513,824  
Furniture and equipment
    735,731       745,578  
Leasehold improvements
    194,899       194,899  
Software development
    107,062       145,315  
Total
    3,427,031       3,599,616  
Less: Accumulated depreciation and amortization
    (2,621,214 )     (2,720,214
Total property and equipment, net
  $ 805,817     $ 879,402  
 
Depreciation expense, included in cost of revenue, general and administrative expenses, and research and development expenses, for the three months ended March 31, 2010 and 2011 was $82,527 and $99,000, respectively.

 
11

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS

4. Loss Per Share
 
The Company calculates net loss per share in accordance with ASC 260, Earnings Per Share,. Under the provisions of ASC 260, basic net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock and dilutive common stock equivalents then outstanding. Common stock equivalents consist of shares of common stock issuable upon the exercise of stock options and warrants.

The following table sets forth the computation for basic and diluted loss per share:

   
Three Months
Ended March 31,
 
  
 
2010
   
2011
 
   
(Unaudited)
 
             
Numerator:
           
Net loss
  $ (2,094,545 )   $ (256,891 )
Numerator for basic and diluted earnings per share
  $ (2,094,545 )   $ (256,891 )
Denominator:
               
Denominator for basic and diluted earnings per share — weighted-average shares
    16,198,788       18,358,892  
Basic and diluted loss per share
  $ (0.13 )   $ (0.01 )

Outstanding stock options and warrants to purchase 1,796,316 shares and 1,861,556 shares for the periods ended March 31, 2010 and 2011, respectively, of which 100,000 warrants are included in these amounts for 2010 and 2011, were excluded from the calculation of diluted loss per share as their effect would have been antidilutive.

5. Commitments and Contingencies
 
Operating Leases

The Company leases office and laboratory space under a noncancelable operating lease that expires on March 31, 2012. The lease contains two two-year options to extend the term of the lease and contains annual scheduled rate increases tied to the Consumer Price Index for the Los Angeles/Long Beach California metropolitan area. The Company also leases space at 103 South Carroll Street, Suite 2b, Fredrick, Maryland 21701, for administrative purposes. This lease has been extended through December 31, 2011 at a rate of $1,500 per month.   Rent expense, included in cost of revenue, general and administrative, and research and development was $102,867 and $131,221 for the three months ended March 31, 2010 and 2011, respectively.
  
Future minimum lease payments by year and in the aggregate, under the Company’s noncancelable operating leases, consist of the following at March 31, 2011:
 
Period Ending March 31, 2011,
     
Remainder of 2011
  $ 358,790  
2012
    162,778  
Thereafter
     
Total
  $ 521,568  
 
 
12

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
5. Commitments and Contingencies – (continued)
 
Guarantees

The Company enters into indemnification provisions under its agreements with other counterparties in its ordinary course of business, typically with business partners, clients and landlords. Under these provisions, the Company generally indemnifies and holds harmless the indemnified party for losses suffered or incurred by the indemnified party as a result of the Company's activities. These indemnification provisions generally survive termination of the underlying agreement. The Company reviews its exposure under these agreements no less than annually, or more frequently when events indicate. The Company believes the estimated fair value of these agreements is minimal as historically, no payments have been made by the Company under these indemnification obligations. Accordingly, the Company has no liabilities recorded for these agreements as of December 31, 2010 and March 31, 2011.

Legal Matters

The Company is, from time to time, involved in legal proceedings, regulatory actions, claims and litigation arising in the ordinary course of business. These matters are not expected to have a material adverse effect upon the Company’s financial statements.

Employment Agreements
 
The Company has employment contracts with several individuals, which provide for annual base salaries and potential bonuses. These contracts contain certain change of control, termination and severance clauses that require the Company to make payments to certain of these employees if certain events occur as defined in their respective contracts.
 
6. License and Collaborative Agreements
 
License Agreement with the University of Southern California (“USC”)
 
In April 2000, as amended in June 2002 and April 2005, the Company entered into a license agreement with USC. Under this agreement, USC granted the Company a worldwide, exclusive license with the right to sublicense, the patents for RGI-1 and related technology, for use in human and veterinary diagnostic laboratory services, the sale of clinical diagnostic products, and the sale of research products to the research community. USC retains the right under the agreement to use the technology for research and educational purposes.

In consideration for this license, the Company agreed to pay to USC royalties based on a percentage of the revenues generated by the use of RGI-1 and related technology. Royalty expense included in cost of revenue relating to this agreement amounted to $96,562 and $125,898 for the three months ended March 31, 2010 and 2011, respectively.

License Agreement with Roche Molecular Systems (“Roche”)
 
In July 2001, the Company entered into a diagnostic services agreement with Roche to provide the Company with access to Roche’s patented PCR technology. In November 2004, this agreement was replaced by a non-exclusive license to use Roche’s PCR, homogenous PCR, and reverse transcription PCR processes. In consideration for these rights, the Company is obligated to pay royalties to Roche, based on a percentage of net sales of products or services that make use of the PCR technology. Royalty expense included in cost of revenue relating to this agreement amounted to $130,495 and $130,544 for the three months ended March 31, 2010 and 2011, respectively.
 
In November 2004, the Company entered into an agreement with Roche, pursuant to which the Company is collaborating with Roche to produce commercially viable assays used in the validation of genetic markers for pharmaceutical companies. Specifically, the Company has licensed the rights to Roche to use the pre-diagnostic assays the Company develops in the course of using its RNA-extraction technologies to provide testing services to pharmaceutical companies and to produce diagnostic kits that then can be sold commercially to those pharmaceutical companies. Roche is required to pay the Company royalties of a certain percentage of net sales of such diagnostic kits sold to pharmaceutical companies. Through March 31, 2011, Roche has not been required to pay any royalties to the Company pursuant to this agreement.

 
13

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
6. License and Collaborative Agreements - (continued)

Services Agreement with Taiho Pharmaceutical Co., Ltd. (“Taiho”)
 
In July of 2001, the Company entered into an agreement with Taiho pursuant to which it will provide Taiho with RGI-1 generated molecular-based tumor analyses for use in guiding chemotherapy treatment for cancer patients and for use in its business developing and marketing pharmaceutical and diagnostic products for use against cancer. Pursuant to the agreement, the Company appointed Taiho as the exclusive purchaser in Japan of tests and testing services based upon the RGI-1 using gene expression for (i) any one or the combination of specified molecular markers, (ii) the therapeutic use of specified compounds, or (iii) the diagnosis or therapeutic treatment of specified precancerous and cancerous diseases. The Company also granted Taiho the right to be a non-exclusive purchaser in Japan of tests and testing services based upon the RGI-1 using gene expression, other than those for which Taiho has exclusivity, for, (i) any one or combination of molecular markers, (ii) the therapeutic use of any compound or biological product against cancer, or (iii) the diagnosis or therapeutic treatment of precancerous and cancerous diseases.

In consideration for the testing services provided, Taiho paid an upfront payment at the commencement of the agreement and is obligated to pay regular testing fees, covering the specific services performed on a monthly basis.  In January 2010, the Company amended its agreement with Taiho and the agreement was renewed for an additional three years. According to the terms of the renewal, Taiho’s appointment as an exclusive purchaser in Japan of certain tests and testing services and its minimum purchasing obligations were extended through 2010.

Revenue recognized from Taiho was $307,925 and $298,825 for the three months ended March 31, 2010 and 2011, respectively.

Services Agreement with SmithKline Beecham Corporation (d.b.a. GlaxoSmithKline or “GSK”)
 
In January 2006, the Company entered into an agreement with GSK, a leading pharmaceutical manufacturer, pursuant to which the Company provides services in connection with profiling the expression of various genes from a range of human cancers. Under the agreement, the Company will provide GSK with testing services as described in individual protocols and GSK will pay the Company for such services based on the pricing schedule established for each particular protocol. GSK is obligated to make minimum annual payments to the Company under the agreement and also was obligated to make a non-refundable upfront payment to the Company, to be credited against work undertaken pursuant to the agreement. In January 2006, the Company received an upfront payment of $2,000,000 which was initially recorded as deferred revenue. The timing of the recognition of these amounts is dependent upon when GSK submits the specimens for testing. The Company recognized $50,217 and $1,014,983 for the three months ended March 31, 2010 and 2011, respectively.

In December 2008, the Company amended and restated its master service agreement with GSK. Pursuant to the amendment, the term of the GSK Agreement has been extended for a two-year period, with the option for the parties to extend the GSK Agreement for additional one-year periods, upon their mutual written agreement. In addition, we will become a preferred provider to GSK and its affiliates of genetic testing services on a fee-for-service basis and, in anticipation of the services to be provided, GSK agreed to make a non-refundable upfront payment of approximately $1,300,000 which was received on January 5, 2009. 

The amount of deferred revenue recognized for this agreement for the period ending March 31, 2011 is $30,582. There is no amount of deferred revenue remaining for the Amended and Restated Master Service Agreement signed in December 2008.

Non-Exclusive License Agreement with GSK

In March 2010, the Company entered into a non-exclusive license agreement with GSK.  Under the agreement, the Company granted GSK a non-exclusive, sublicenseable license to its proprietary PCR analysis technology and diagnostic expertise to assess BRAF gene mutations in human tumor samples.  As part of the agreement, the Company received a non-refundable technology access fee in consideration for the transfer of the Company’s technology to GSK. The agreement also contains milestone provisions which would allow the Company to earn further payments from GSK.  The Company had not earned any milestone payments from GSK as of March 31, 2011.

 
14

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
6. License and Collaborative Agreements - (continued)

Master Laboratory Test Services Agreement with GlaxoSmithKline Biologicals (“GSK Bio”)
 
In December 2006, the Company entered into an agreement with GSK Bio, the vaccine division of GSK (see above), pursuant to which it will provide testing services, principally in relation to profiling the expression of various genes from a range of human cancers. The Company will conduct the testing services on tissue specimens provided by GSK Bio. The agreement required that GSK Bio make an upfront payment of €2,000,000 (approximately $2,620,000), which was received by the Company in December 2006. The agreement further specified that GSK Bio  pay annual minimum payments in 2007, 2008 and 2009 and that the upfront payment made in December 2006 will be credited against the annual minimum payments in 2007 and 2008. The agreement also provided that any differences between the annual minimum payments made in 2007, 2008 or 2009 and the amounts due to the Company for testing services performed on specimens submitted by GSK Bio during the three years ended December 31, 2009 be credited towards services performed during the year ending December 31, 2010, the final year of the agreement. If the Company ceases to provide services under the agreement or any reason, the Company shall remit to GSK Bio payment of the then remaining balance of the existing credit within sixty days of the date on which the Company ceased to provide services to GSK Bio.

In December 2007, the Company amended its agreement with GSK Bio whereby GSK Bio would make the remaining minimum payments under the agreement in one lump sum. This payment of approximately $2,722,000 was received in January 2008.

On September 7, 2009, the Company amended and restated its master service agreement with GSK Bio (the “Amended and Restated Agreement”).  Pursuant to the Amended and Restated Agreement, the parties agreed that GSK Bio has accrued an aggregate credit under the terms, representing the balance of deferred revenue relating to this agreement at that date of the original agreement, which amount shall be allocated towards services rendered to GSK Bio during the remaining term of the agreement as described below.

For each calendar quarter of 2009 and the first two quarters of 2010, €200,000 of the existing credit shall apply to all services rendered to GSK Bio during such calendar quarter.  Pursuant to the Amended and Restated Agreement, GSK Bio has extended the term of the agreement for an additional one-year period through December 31, 2011.  As provided in the Amended and Restated Agreement, the remaining balance of the existing credit of approximately €1,357,800 was divided into six equal quarterly amounts and will be applied to all services rendered to GSK Bio in each of the last two quarters of 2010 and the four calendar quarters of 2011.  In the first quarter of 2011, the amount of the credit to be applied to all services rendered to GSK Bio is €226,300. In all cases, GSK Bio shall remit payment to the Company for all services rendered to GSK Bio in any such calendar quarter that is in excess of the applicable credit amount.  In the event the amount of services rendered to GSK Bio in a calendar quarter does not exceed the applicable credit amount, the existing credit for the following calendar quarter shall be increased by such unused amount. 

The Amended and Restated Agreement further provides that the Company shall provide additional services on a fee-for-service basis, upon GSK Bio’s written request, relating to the bridging of assays/diagnostic tests to third parties that develop, manufacture and sell the commercial diagnostic tests to be used with certain of GSK Bio’s products. The amount of deferred revenue for this agreement at December 31, 2010 and March 31, 2011 is $1,333,186 and $999,888, respectively.  The timing of the recognition of these amounts is dependent upon when GSK Bio submits the specimens for testing. The Company recognized revenue of $1,023,217 and $1,485,706 relating to the GSK Bio agreement for the three months ended March 31, 2010, and 2011, respectively, but only $333,296 was recorded against the deferred revenue balance. 
 
Collaboration Agreement with Shanghai BioChip Company, Ltd. (“SBC”)
 
On March 5, 2007, the Company entered into a collaboration agreement with SBC pursuant to which SBC will provide exclusive pharmacogenomic testing services to the Company’s clients in China.
 
Pursuant to the agreement, the Company has granted SBC an exclusive license in China to provide services in China using the Company’s proprietary RNA extraction technologies. Subject to consent from USC, the Company will grant SBC an exclusive sublicense to patents licensed from USC for distribution of testing services in China. In turn, SBC will perform RNA extraction from FFPE tissue specimens exclusively for the Company during the term of the agreement.
 
This agreement has an initial term of five years, with an automatic renewal for an additional three-year term unless either party gives 90 days notice in advance of the renewal date of its intent not to renew. Pursuant to the agreement, SBC will receive a percentage of the gross margin, as defined in the agreement, collected from the Company’s clients in China as compensation for its testing services performed. No testing services performed for the three months ended March 31, 2010. For the three months ended March 31, 2011, the amount of gross  margin due to SBC for testing services performed totaled to $74,853, respectively.
 
Commission Agreement with Hitachi Chemical Co., Ltd.
 
On July 26, 2007, the Company entered into a collaboration agreement with Hitachi Chemical Co., Ltd. (“Hitachi”), a leading diagnostics manufacturer in Japan (the “Hitachi Agreement”). Under the terms of this agreement, Hitachi will begin using the Company's proprietary and patented techniques to extract genetic information from formalin-fixed paraffin-embedded (“FFPE”) tissue samples collected in Southeast Asia, Australia and New Zealand. As part of this collaboration agreement, the Company will provide Hitachi with the technical information and assistance necessary to perform the testing services. Hitachi also plans to introduce the Company to potential new testing services customers in the region to expand the testing of FFPE clinical samples in Asia. The Southeast Asian countries covered under this agreement include Japan, North Korea, South Korea, Taiwan, Mongolia, Pakistan, Bangladesh, Sri Lanka, Nepal, Singapore, Malaysia, Indonesia, Brunei, Thailand, Myanmar, Laos, Cambodia, Vietnam and the Philippines (the “Territory”).
 
This Agreement has an initial term expiring on March 31, 2010, with an automatic renewal for one year at the end of the original period under the same terms and conditions. Pursuant to the agreement, Hitachi will receive a percentage of the revenue collected from the Company's clients in the Territory for its testing services performed which totaled $302,644 and $240,971 for the three months ended March 31, 2010 and 2011, respectively.

 
15

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
7. Stock Option Plan
 
In March 2000, the Company adopted a Stock Option Plan (the “2000 Plan”) as approved by its board of directors. Under the 2000 Plan, the Company may grant options to acquire up to 1,600,000 shares of common stock. In connection with the adoption of the 2006 Employee, Director and Consultant Stock Plan, as further discussed below, the Company will grant no additional options under its 2000 Plan under which options to purchase 190,000 shares remained outstanding as of March 31, 2011. Although no more options may be granted under the 2000 Plan, the terms of the 2000 Plan continue to apply to all outstanding options. The Company also granted options to purchase 16,000 shares of common stock to two consultants which were granted under separate agreements outside of the 2000 Plan.
 
On October 26, 2006, the Board of Directors of the Company approved, and on May 1, 2007, reapproved the adoption of the 2006 Employee, Director and Consultant Stock Plan (the “2006 Stock Plan”). The stockholders approved the 2006 Stock Plan on June 1, 2007. The initial number of shares which may be issued from time to time pursuant to this Plan is 2,160,000 shares of common stock.  In addition, on the first day of each fiscal year of the Company during the period beginning in fiscal year 2008, and ending on the second day of fiscal year 2017, the number of shares that may be issued from time to time pursuant to the Plan shall be increased by 200,000 shares.  The initial number of shares available for issuance of 2,160,000 increased by 200,000 in 2008, 2009 and 2010, resulting in the total number of shares that may be issued as of January 1, 2011 to be 2,760,000.  As of March 31, 2011, there were 898,444 options available to grant under the 2006 Stock Plan.
 
Employee options vest according to the terms of the specific grant and expire 10 years from the date of grant. Non-employee option grants to date vest typically over a 2 to 3 year period. The Company had 1,861,555 options outstanding at a weighted average exercise price of $3.92 at March 31, 2011. There were 891,778 non-vested stock options with a weighted average grant date fair value of $1.26 outstanding at March 31, 2011.  As of March 31, 2011, there was $1,122,736 of total unrecognized compensation cost related to non-vested share-based compensation arrangements granted under the Plan.  That cost is expected to be recognized over a weighted-average period of 2.51 years.

The Company estimated share-based compensation expense for the three months ended March 31, 2011 using the Black-Scholes model with the following weighted average assumptions:
 
   
2011
 
Risk free interest rate
    3.01%  
Expected dividend yield
     
Expected volatility
    121%  
Expected term (in years)
    6.25  
Forfeiture rate
    7.5%  

 * The Company did not issue any grants for the three months ended March 31, 2010

The following table summarizes the stock option activity for the three months ended March 31, 2011:

   
Number of
Shares
   
Weighted
Average
Exercise
Price
   
Remaining
Contractual
Life (Years)
   
Aggregate
Intrinsic
Value
 
Outstanding, December 31, 2010
    1,995,280     $ 4.18       7.62     $ 446,501  
Granted (Unaudited)
    100,721     $ 2.29                  
Exercised (Unaudited)
    (4,314   $ 1.35                  
Forfeited (Unaudited)
    (230,131   $ 5.49                  
Outstanding, March 31, 2011 (Unaudited)
    1,861,556     $ 3.92       7.72     $ 342,391  
Exercisable, March 31, 2011 (Unaudited)
    970,378     $ 5.05       6.90     $ 140,214  

Information about stock-based compensation included in the results of operations for the three months ended March 31, 2010 and 2011 are as follows:

   
Three Months Ended
March 31,
 
   
(Unaudited)
 
  
 
2010
   
2011
 
Cost of revenue
  $ 33,578     $ 74,236  
Research and development
    6,228       5,110  
Sales and marketing
          8,258  
General and administrative
    79,340       117,438  
Totals
  $ 119,146     $ 205,042  
 
8 . Common Stock Warrants>
 
The Company issues warrants to purchase common shares of the Company either as compensation for services or as additional incentive for investors who may purchase common stock. The value of warrants issued for compensation is accounted for as a non-cash expense to the Company at the fair value of the warrants issued.

In June 2007, in conjunction with the initial public offering, the Company issued 100,000 warrants to purchase 100,000 shares of its common stock at an exercise price of $7.70 to the underwriters as part of the initial public offering.

There were no warrants granted during the three months ended and March 31, 2010 and 2011.  As of March 31, 2011, all of the warrants were outstanding and exercisable and had a remaining contractual life of 1.25 years.
 
 
16

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
9. Income Taxes
 
Deferred income taxes result from temporary differences between income tax and financial reporting computed at the effective income tax rate. The Company has established a valuation allowance against its net deferred tax asset due to the uncertainty surrounding the realization of such asset. Management periodically evaluates the recoverability of the deferred tax assets. At such time it is determined that it is more likely than not that deferred tax assets are realizable, the valuation allowance will be reduced.
 
We file U.S. federal, U.S. state, and foreign tax returns. Our major tax jurisdictions are U.S. federal and the State of California and are subject to tax examinations for the open years from 2001 through March 31, 2011.
 
10. Related Party Transactions
 
While employed at USC, Kathleen Danenberg, president, chief executive officer and director, developed and patented (United States Patent 6,248,535; Danenberg , et al., Method For Isolation of RNA From Formalin-Fixed Paraffin-Embedded Tissue Specimens) an extraction method that allowed reliable and consistent isolation of RNA from FFPE suitable for RT-PCR. USC retains ownership of this patent but has exclusively licensed this technology to the Company. In consideration for this license, the Company is obligated to pay royalties to USC, as a percentage of net sales of products or services using the technology, and to meet a certain minimum in royalty payments. Pursuant to USC policy, the inventors of technology owned by the University and then licensed for commercialization are paid a portion of royalties received by the University from the licensed technology. USC therefore pays a portion of royalties received from the Company to Mrs. Danenberg in recognition of her invention.  Mrs. Danenberg was paid $14,593 for the three months ended March 31, 2010.  For the three months ended March 31, 2011, Mrs. Danenberg received no compensation under this agreement. 
 
11. Segment Information
 
The Company operates in a single reporting segment, with an operating facility in the United States.
 
The following enterprise wide disclosure was prepared on a basis consistent with the preparation of the consolidated financial statements. The following tables contain certain financial information by geographic area:
 
   
Three Months 
Ended March 31,
 
Net Revenue:
 
2010
   
2011
 
   
(Unaudited)
 
United States
  $ 2,365,766     $ 4,140,372  
Europe
    1,023,217       1,488,378  
Japan
    307,925       298,825  
  
  $ 3,696,908     $ 5,927,575  
 
Long-lived assets:
 
December 31,
2010
   
March 31,
2011
(Unaudited)
 
United States
  $ 805,817     $ 879,402  
 
17

 

RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
 
There are no current operations in the U.K. subsidiary. The operating costs related to the U.K. subsidiary were $3,405 and $3,658 for the three months ended March 31, 2010 and 2011, respectively, included in the general and administrative expenses in the accompanying statements of operations.

13. Private Placements
 
On February 27, 2009, the Company entered into a Purchase Agreement with certain affiliates of Special Situations Funds for the private placement of 2,000,000 newly-issued shares of the Company's common stock at a per share price of $1.00. The closing of the sale of the Shares occurred on March 2, 2009.  The aggregate offering price of the shares was $2 million and the Company received the funds on March 2, 2009.

In connection with the Special Situations Funds Private Placement, we also entered into a Registration Rights Agreement, dated February 27, 2009, with the Purchasers (the "Registration Rights Agreement") pursuant to which the Company filed a registration statement with the Securities and Exchange Commission ("SEC") to register the 2,000,000 shares for resale, which registration statement became effective on June 30, 2009.

Common stock classified outside of stockholders’ equity (deficit)

On July 22, 2009, the Company entered into a Purchase Agreement with certain funds managed by Lansdowne Partners Limited Partnership for the private placement of 3,057,907 newly-issued shares of the Company's common stock at a per share price of $1.30. The closing of the sale of the shares occurred on July 22, 2009.  The aggregate offering price of the shares was approximately $4 million and the Company received the funds on July 23, 2009.  In connection with the acquisition of the shares, the Purchasers were granted certain preemptive rights permitting them to maintain their percentage ownership interests in connection with future issuances of the Company’s capital stock, subject to various exceptions and limitations.

Pursuant to the Lansdowne Registration Rights Agreement which is dated July 22, 2009, the Company filed a registration statement with the SEC to register the 3,057,907 shares sold to Lansdowne for resale, which became effective on November 3, 2009 and which registration statement is currently effective.

Under the Lansdowne Registration Rights Agreement, the Company was required to have the registration statement declared effective within 120 days after the private placement closed.  In addition, the Company is obligated to use commercially reasonable efforts (i) to cause the registration statement described above to remain continuously effective and (ii) to maintain the listing of the Company’s common stock on Nasdaq or other exchanges, as defined, for a period that will terminate on the earlier of July 22, 2012 or the date on which Lansdowne has sold all of its shares of common stock.  The Company is also required to file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act. In the event the Company fails to satisfy its obligations under the Lansdowne Registration Rights Agreement, the Company would be in breach of said agreement, in which event Lansdowne would be entitled to pursue all rights and remedies at law or equity including an injunction or other equitable relief.  The Lansdowne Registration Rights Agreement does not provide an explicitly stated or defined penalty due upon a breach.  Because (i) the potential penalty for any breach of the Lansdowne Registration Rights Agreement is not explicitly stated or defined, which prohibits the Company from applying the guidance of ASC 825-20-15, Registration Payment Arrangements and (ii) complying will all filing requirements under the 1934 Act as described above is not solely within the Company’s control, the Company is required to present Lansdowne’s investment of $3,975,279 in the Company’s common stock as common stock outside of stockholders’ equity in the accompanying consolidated balance sheet under ASC 480-10-S99-3, Classification and Measurement of Redeemable Securities.
 
On March 5, 2010, the Company entered into a Purchase Agreement with certain affiliates of and funds managed by Lansdowne Partners Limited Partnership, Greenway Capital Partners and Paragon Associates for the private placement of 3,005,349 newly-issued shares of our common stock at a per share price of $1.31.  The closing of the sale of the shares occurred on Friday, March 5, 2010.  In connection with the acquisition of the shares, the Purchasers were granted certain preemptive rights permitting them to maintain their percentage ownership interests in connection with future issuances of the Company ’ s capital stock, subject to various exceptions and limitations.  Lansdowne participated in the Private Placement by electing to exercise the preemptive rights granted to it pursuant to the Purchase Agreement by and between the Company and Lansdowne, dated July 22, 2009.  Net proceeds received from this financing were approximately $3,879,403.
 
In connection with the Private Placement, the Company also entered into a Registration Rights Agreement, dated March 5, 2010, with the Purchasers (the “Registration Rights Agreement”) pursuant to which it has agreed to file, within 45 days of the closing of the Private Placement, a registration statement with the SEC to register the shares for resale, which registration statement is required to become effective within 120 days following the closing.  The Company also granted certain "piggyback" registration rights to the Purchasers which are triggered if the Company proposes to file a registration statement for its own account or the account of one or more shareholders until the earlier of the sale of all of the shares or the shares become eligible for sale under Rule 144(b)(1) without restriction.

 
18

 
RESPONSE GENETICS, INC.
 
NOTES TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
 
13. Private Placements – (continued)

Under the Registration Rights Agreements with the Purchasers, the Company is obligated to use commercially reasonable efforts to (i) cause the registration statements described above to remain continuously effective and (ii) to maintain the listing of Company’s common stock on Nasdaq or other exchanges, as defined, for a period that will terminate on the earlier of March 5, 2013 or the date on which the Purchasers have sold all shares of common stock.  The Company is also required to file with the SEC in a timely manner all reports and other documents required of the Company required of the Company under the 1934 Act.  In the event the Company fails to satisfy its obligations under the registration rights agreements, the Company would be in breach of said agreements, in which event, the Purchases would be entitled to pursue all rights and remedies at law or equity including an injunction or other equitable relief. These registration rights agreements do not provide an explicitly stated or defined penalty due upon a breach.  Because (i) the potential penalty for any breach of these Registration Rights Agreement is not explicitly stated or defined, which prohibits the Company from applying the guidance of ASC 825-20-15, Registration Payment Arrangements and (ii) complying with all filing requirements under the 1934 Act as described above is not solely within the Company’s control, the Company  is required to present the investment of approximately $3,879,403 in the Company’s common stock as common stock outside of stockholders’ equity in the accompanying consolidated balance sheet under ASC 480-10-S99-3, Classification and Measurement of Redeemable Securities .

As of December 31, 2010 and March 31, 2011, a total of $7,854,682 of common stock was classified outside of stockholders’ equity (deficit).

14. Fair Value Measurements

On January 1, 2009, the Company adopted ASC 820 (formerly SFAS No. 157) which defines fair value, establishes a framework for measuring fair value in generally accepted accounting principles, and expands disclosures about fair value measurements. ASC 820 does not require any new fair value measurements, but provides guidance on how to measure fair value by providing a fair value hierarchy used to classify the source of the information.  ASC 820 establishes a three-level valuation hierarchy of valuation techniques that is based on observable and unobservable inputs. Classification within the hierarchy is determined based on the lowest level of input that is significant to the fair value measurement. The first two inputs are considered observable and the last unobservable, that may be used to measure fair value and include the following:

Level 1 - Quoted prices in active markets for identical assets or liabilities.
 
Level 2 - Inputs other than Level 1 that are observable, either directly or indirectly, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities.
 
Level 3 - Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

As of March 31, 2011, the Company held certain assets and liabilities that are required to be measured at fair value on a recurring basis, including its cash and cash equivalents. The fair value of these assets and liabilities was determined using the following inputs in accordance with ASC 820 at March 31, 2011:
 
   
Fair Value Measurement as of March 31, 2011
 
  
 
Total
   
Level 1
   
Level 2
   
Level 3
 
Description
 
$
   
$
   
$
   
$
 
Money market accounts (1)
    1,600,885       1,600,885       -       -  
 
(1)
Included in cash and cash equivalents on the accompanying consolidated balance sheet.
 
15. Subsequent Events
 
           On May 6, 2011, the Company issued 1,175,512 shares of its common stock at a price of $1.99 per share in a registered direct public offering to certain institutional investors and expects to receive net proceeds of approximately $2.2 million from the sales, after deducting its estimated offering expenses. The securities issued with this financing will be registered under the Securities and Exchange Act of 1933, as amended, The shares are being issued pursuant to a prospectus supplement dated May 4, 2011 and an accompanying prospectus dated January 6, 2011, pursuant to the Company’s existing effective shelf registration statement on Form S-3 (File No. 333-171266), which was filed with the Securities and Exchange Commission on December 17, 2010 and declared effective by the SEC on January 6, 2011. 

 
19

 

Item 2: Managements Discussions and Analysis
 
Special Note Regarding Forward Looking Statements
 
Certain statements in this report constitute “forward-looking statements.” These forward-looking statements involve known or unknown risks, uncertainties and other factors that may cause the actual results, performance, or achievements of Response Genetics, Inc. to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Specifically, the actions of competitors and customers and our ability to execute our business plan, and our ability to increase revenues is dependent upon our ability to continue to expand our current business and to expand into new markets, general economic conditions, and other factors. You can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “intends,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues,” or the negative of these terms or other comparable terminology. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. We undertake no obligations to publicly update or review any forward-looking statements, whether as a result of new information, future developments or otherwise.

The following discussion of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes to the financial statements included elsewhere in this Quarterly Report on Form 10-Q as of March 31, 2011 and our audited financial statements for the year ended December 31, 2010 included in our Annual Report on Form 10-K previously filed with the SEC. This discussion contains forward-looking statements that relate to future events or our future financial performance. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward looking statements.
 
Overview
 
Response Genetics, Inc. (the “Company”) was incorporated in the state of Delaware on September 23, 1999 as Bio Type, Inc. for the purpose of providing unique molecular profiling services of tumor tissue that has been formalin-fixed and embedded in paraffin wax. In August 2000, we changed our name to Response Genetics, Inc. In November 2006, we established Response Genetics Ltd., a wholly owned subsidiary in Edinburgh, Scotland. On February 9, 2009 we implemented a reduction of workforce pursuant to which we closed our subsidiary in Edinburgh. See "liquidity and capital resources" for additional information.

Clinical studies have shown that not all cancer chemotherapy works effectively in every patient, and that a number of patients receive therapy that has no benefit to them and may potentially even be harmful. Our goal is to provide cancer patients and their physicians with a means to make informed, individualized treatment decisions based on genetic analysis of tumor tissues. Our pharmacogenomic analysis of clinical trial specimens for the pharmaceutical industry may provide data that will lead to a better understanding of the molecular basis for response to specific drugs and, therefore lead to individualized treatment. We are focusing our efforts in the following areas:
 
 
Continued commercialization of our ResponseDX ™ tests;

 
•  
Developing additional diagnostic tests for assessing the risk of cancer recurrence, prediction of chemotherapy response and tumor classification in cancer patients; and

 
•  
Expanding our pharmacogenomic testing services business into and creating a standardized and integrated testing platform in the major markets of the healthcare industry, including outside of the United States.
 
Our patented technologies enable us to reliably and consistently extract the nucleic acids RNA and DNA from tumor specimens that are stored as formalin-fixed and paraffin-embedded, specimens and thereby to analyze genetic information contained in these tissues. This is significant because the majority of patients diagnosed with cancer have a tumor biopsy sample stored in paraffin, while only a small percentage of patients’ tumor specimens are frozen. Our technologies also enable us to use the FFPE patient biopsies for the development of diagnostic tests. To our knowledge, we were the first company to generate clinically relevant information regarding the risks of recurrence of cancer or chemotherapy response using approximately 30,000 genes available from microarray profiling of FFPE specimens.

 
20

 
ResponseDX™
 
The outcome of cancer chemotherapy is highly variable due to genetic differences among patients. Some patients respond well with tumor shrinkage and increase in life span. Other patients do not obtain benefit from the same therapy but may still experience toxic side effects as well as delay in effective treatment and psychological trauma.

At present, most chemotherapy regimens are administered without any pre-selection of patients on the basis of their particular genetics. However, recent development of very sensitive molecular technologies has enabled researchers to identify and measure genetic and biochemical factors in patients’ tissues that may predict the probability of success or failure of many currently used anti-cancer agents. In order to increase the chances of a better chemotherapy outcome for cancer patients, we are developing genetic tests that will measure predictive factors for tumor response in tumor tissue samples. We have begun offering tests for non-small cell lung cancer (NSCLC) (ResponseDX: Lung ™ ),  colorectal cancer (CRC) (ResponseDX: Colon™) and gastric and gastroesophageal (GE) cancer  (ResponseDX: Gastric™) patients’ tumor tissue through our laboratory located in Los Angeles, California, which is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), and we anticipate offering additional tests for ovarian and pancreatic cancer in the future. These tests are proprietary based tests which serve to help oncologists make optional therapeutic decisions for cancer patients. The results from our tests may help oncologists choose among chemotherapy regimens to treat their cancer patients. Currently, our recently formed sales team has been expanded to 16 sales people located in the West Coast, Midwest, and East Coast areas of the United States.

Diagnostic Tests for Other Cancers
 
In addition to ResponseDX:Lung, ResponseDX:Colon, and ResponseDX: Gastric, we are developing and intend to commercialize tests for other types of cancer that identify genetic profiles of tumors that are more aggressive and recur rapidly after surgery. We also are identifying genetic profiles of tumors that are more or less responsive to a particular chemotherapy. Following the development of tests to predict the risk of recurrence after surgery, we intend to develop tests to determine the most active chemotherapy regimen for the individual patient at risk. Once developed and after obtaining any necessary regulatory approvals, we intend to leverage our relationships in the healthcare industry to market, sell or license these tests as a means for physicians to determine the courses of cancer treatment.

Expansion of our pharmacogenomic testing services business
 
We have started the expansion of our pharmacogenomic testing services business into major markets of the healthcare industry outside of the United States. We have a service laboratory in Japan and in China, through collaboration with some of our current clients in the pharmaceutical industry. The pharmaceutical industry is in need of standardized integrated worldwide analysis of clinical trial specimens. It is important to the pharmaceutical industry and the regulatory agencies that the same analytical methods are used for each clinical trial sample around the world so that the data can be easily compared and used for global drug development. Also, export of clinical trial specimens to the United States is restricted from some areas of the world, such as China. Our goal is to offer an analysis of patient specimens and generate consistent data based on integrated common platforms and technology into the major markets of the healthcare industry including outside of the United States.

There are no assurances that we will be able to continue making our current ResponseDX tests available, or make additional ResponseDX tests available; will be able to develop and commercialize tests of other types of cancer; or will be able to expand our pharmacogenomic testing service business.

We anticipate that over the next 12 months, a substantial portion of our capital resources and efforts will be focused on research and development to expand our series of diagnostic tests for cancer patients, sales and marketing activities related to our ResponseDX diagnostic tests, and for other general corporate purposes.

Research and development expenses represented 9.9% and 2.7% of our total operating expenses for the three months ended March 31, 2010 and 2011, respectively. Major components of the $572,184 and $164,342 in research and development expenses for the three months ended March 31, 2010 and 2011, included supplies and reagents for our research activities, personnel costs, occupancy costs, equipment warranties and service, patent fees, insurance, business consulting and sample procurement costs.
 
 
21

 
 
Critical Accounting Policies and Significant Judgments and Estimates
 
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires management to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as revenues and expenses during the reporting periods. We evaluate our estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results could therefore differ materially from those estimates under different assumptions or conditions. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements.

Revenue Recognition
 
Revenues are derived from services provided to pharmaceutical companies and from revenues generated from our ResponseDX tests. Revenue is recognized in accordance with ASC 605-10-S99 Revenue Recognition, which requires that four basic criteria must be met before revenue can be recognized: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred and title and the risks and rewards of ownership have been transferred to the client or services have been rendered.  We record revenues when our tests have confirmed results which is evidence that the services have been performed; (3) the price is fixed or determinable; and (4) collectability is reasonably assured

Revenues from pharmaceutical company contracts are recorded on an accrual basis as the contractual obligations are completed and as a set of assays is processed through our laboratory under a specified contractual protocol. Certain contracts have minimum assay requirements that, if not met, result in payments that are due upon the completion of the designated period. In these cases, revenues are recognized when the end of the specified contract period is reached.
 
On occasion, we may enter into a contract that requires the client to provide an advance payment for specimens that will be processed at a later date. In these cases, we record this advance as deferred revenue and recognize the revenue as the specimens are processed or at the end of the contract period, as appropriate.
 
Effective April 1, 2010, we recognize all product from ResponseDX tests on an accrual basis.  Through March 31, 2010, we recognized revenue from Private Payors on a cash basis as we had not, until then, established a collection history.  As of April 1, 2010, a pattern of collections was reasonably established and we began to record revenues from Private Payors of ResponseDX on an accrual basis. We have received our Medicare provider number which allows us to invoice and collect from Medicare. Our invoicing to Medicare is primarily based on amounts allowed by Medicare for the service provided as defined by Common Procedural Terminology (CPT) codes.

We are subject to potentially significant variations in the timing of revenue recognized from period to period due to a variety of factors including: (1) the timing of when specimens are submitted to us for testing; and (2) the specific terms, such as minimum assay requirements in any given period, advance payment requirements, and terms of agreements, as set forth in each contract we have with significant clients.
 
License Fees
 
We have licensed technology for the extraction of RNA and DNA from FFPE tumor specimens from USC in exchange for royalty fees on revenue generated by use of this technology. These royalties are calculated as a fixed percentage of revenue that we generate from use of the technology licensed from USC. Total license fees expensed in cost of revenue under the royalty agreement to USC were $96,562 and $125,898 for the three months ended March 31, 2010 and 2011, respectively. We also maintain a non-exclusive license to use Roche’s polymerase chain reaction (PCR), homogenous PCR, and reverse transcription PCR processes. We pay Roche a fixed percentage royalty fee for revenue that we generate through use of this technology. Royalties expensed in cost of revenue under this agreement totaled $130,495 and $130,544 for the three months ended March 31, 2010 and 2011, respectively.

We are subject to potentially significant variations in royalties recorded in any period. While the amount paid is based on a fixed percentage from revenues of specific tests pursuant to terms set forth in the agreements with USC and Roche, the amount due is calculated based on the revenue we recognize using the respective licensed technology. As discussed above, this revenue can vary from period to period as it is dependent on the timing of the specimens submitted by our clients for testing.

 
22

 
 
Accounts Receivable
 
We invoice our pharmaceutical clients as specimens are processed and any other contractual obligations are met. Our contracts with pharmaceutical clients typically require payment within 45 days of the date of invoice. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our clients to make required payments. We specifically analyze accounts receivable and historical bad debts, client credit, current economic trends and changes in client payment trends when evaluating the adequacy of the allowance for doubtful accounts. Account balances are charged-off against the allowance when it is probable the receivable will not be recovered. To date, our clients have primarily been large pharmaceutical companies. As a result, bad debts to date have been minimal and there is no allowance for doubtful accounts for our pharmaceutical revenue at either December 31, 2010 or March 31, 2011.
 
We bill Medicare and Private  Payors for ResponseDX upon completion of the required testing services. As such, we take assignment of benefits and the risk of collection with Medicare and Private Payors. We continue to monitor the collection history for Medicare and Private Payors.  Based on the historical experience for our Medicare accounts, we have determined that billings over one year old are unlikely to be collected.  Therefore, we have recognized bad debt expense and reduced our receivables by $140,218 as of March 31, 2011.

We cannot guarantee that we will continue to experience the same credit loss rates that we have in the past. Measurement of such losses requires consideration of historical loss experience, including the need to adjust for current conditions, and judgments about the probable effects of relevant observable data, including present economic conditions such as delinquency rates and financial health of specific customers. We consider all available information in our assessments of the adequacy of the reserves for uncollectible accounts. 

Income Taxes
 
We estimate our tax liability through calculations we perform for the determination of our current tax liability, together with assessing temporary differences resulting from the different treatment of items for tax and accounting purposes. These differences result in deferred tax assets and liabilities, which are recorded in our balance sheets. Our management then assesses the likelihood that deferred tax assets will be recovered in future periods through future operating results. To the extent that we cannot conclude that it is more likely than not that the benefit of such assets will be realized, we establish a valuation allowance to adjust the net carrying value of such assets. The carrying value of our net deferred tax assets assumes that we will be able to generate sufficient future taxable income, based on management’s estimates and assumptions. These estimates and assumptions take into consideration future taxable income and ongoing feasible tax strategies in determining recoverability of such assets. Our valuation allowance is subject to significant change based on management’s estimates of future profitability and the ultimate realization of the deferred tax assets. The Company has established a full valuation allowance against its net deferred tax assets due to the uncertainty surrounding the realization of such assets.

Results of Operations
 
Quarters Ended March 31, 2011 and March 31, 2010
 
Revenues:  Revenues were $5,927,575 for the quarter ended March 31, 2011, as compared to $3,696,908 for the quarter ended March 31, 2010, an increase of $2,230,667, or 60.3%.   Revenues, excluding the net revenue impact of $164,833 resulting from the conversion to the accrual basis of revenue recognition for Private Payors, were $5,762,742 for the quarter ended March 31, 2011, as compared to $3,696,908 for the quarter ended March 31, 2010, an increase of $2,065,834, or 55.9%.  The increase was primarily due to increases in ResponseDX revenue of $1,380,023 and pharmaceutical revenues of $1,445,094.  Excluding the net revenue impact of $164,832 for the quarter ended March 31, 2011, ResponseDX revenue accounted for 52.3% of total revenue compared to 46.5% for the quarter ended March 31, 2010.  Excluding the net revenue impact of $164,833, ResponseDX revenues for the quarter ended March 31, 2011, as compared to the quarter ended March 31, 2010, increased 80.2%.  For the quarter ended March 31, 2011, our two most significant pharmaceutical customers accounted for approximately 42.2% of our revenue, as compared to approximately 43% of our revenue for the quarter ended March 31, 2010.
 
Cost of Revenues:   Cost of revenues for the quarter ended March 31, 2011 were $2,700,922 as compared to $2,133,808 for the quarter ended March 31, 2010, an increase of $567,114 or 26.6%.  This increase resulted primarily from increases in personnel costs of $301,039, lab supplies and reagent costs of $218,779, health insurance costs of $60,401, royalties of $60,881 and shipping costs of $45,415, offset in part by a decrease in legal services of $50,574 and temporary help of $36,436.  Cost of revenues as a percentage of revenues was 45.6% for the quarter ended March 31, 2011, as compared to 57.7% for the quarter ended March 31, 2010, a decrease of 12.1%. Excluding the net revenue impact of $164,832 resulting from the conversion to accrual for Private Payors, cost of revenues as a percentage of revenue was 46.3% as compared to 57.7% for the quarter ended March 31, 2010, a decrease of 11.4%.  
 
Research and Development Expenses:   Research and development expenses were $164,342 for the quarter ended March 31, 2011, as compared to $572,184 for the quarter ended March 31, 2010, a decrease of $407,842 or 71.3%.  This decrease resulted primarily from decreases in consulting costs of $8,630, temporary help of $15,746, postage of $8,188, personnel costs of $124,300, foreign currency losses of $16,490, legal costs of $28,476 and reagent and lab supply costs of $141,809. Even though research and development expenses decreased during this quarter, we expect research and development expenses to increase as we continue work to develop additional aspects of our technology and to study diagnostic indicators for various forms of cancer.
 
General and Administrative Expenses:  General and administrative expenses were $1,877,346 for the quarter ended March 31, 2011, as compared to $1,659,308 for the quarter ended March 31, 2010, an increase of $218,038 or 12.9%.  This increase resulted primarily from increases in personnel costs of $81,720, business taxes of $16,712, consulting costs of $30,043, equipment maintenance of $22,437, bad debt expense of $35,804 and billing service costs of $48,326, offset in part by a reduction in expense of legal fees of $55,892.  

Sales and Marketing Expenses:   Sales and marketing expenses were $1,439,125 for the quarter ended March 31, 2011, as compared to $1,415,871 for the quarter ended March 31, 2010, an increase of $23,254 or 1.6%.  The increase primarily resulted from increased sales and marketing activities for ResponseDX, which included increases in personnel costs of $282,104. These increases were offset by decreases of expense for speaker fees of $73,450, advertising of $60,586, business consulting of $21,000 and legal services of $28,604.  We expect that sales and marketing costs will continue to increase as we expand our sales and marketing activities in order to gain clinical acceptance of our ResponseDX assays.
 
United Kingdom (U.K.) Expenses: 

The operating costs related to our UK subsidiary were $3,658 for the quarter ended March 31, 2011 compared to $3,405 for the same comparable period in 2010. For presentation purposes the amount of expense for the U.K. subsidiary is included in general and administrative expenses in the accompanying statement of operations. 
 
 
23

 
 
Interest Income:   Interest income was $52 for the quarter ended March 31, 2011, compared with $99 for the same period in 2010. This $47 decrease was due to lower rates of return during the period ending March 31, 2010.
 
Income Taxes:   As of March 31, 2011 and 2010, a full valuation allowance has been recorded for the deferred tax assets since we do not believe the recoverability of the deferred income tax assets in the near future is more likely than not.

Liquidity and Capital Resources
 
We incurred net losses of $2,094,545 and $256,891 during the quarters ended March 31, 2010 and 2011, respectively. Since our inception in September 1999, we have incurred cumulative losses and as of March 31, 2011, we had an accumulated deficit of $44,074,053. We have not yet achieved profitability and anticipate that we will likely incur additional losses.  We cannot provide assurance as to when will achieve profitability. We expect that our cash and cash equivalents will be used to fund our selling and marketing activities primarily related to our ResponseDX tests, research and development, and general corporate purposes. As a result, we will need to generate significant revenues to achieve profitability.  Management expects that cash on the balance sheet plus cash generated from operations will be sufficient to meet current obligations through the first quarter of 2012. Nevertheless, until we can generate and maintain sufficient revenues to finance our cash requirements, which we may never do, we expect to finance additional cash needs primarily through public or private equity offerings, strategic collaborations, and other financing opportunities as they may arise.  We do not know whether additional funding will be available on acceptable terms, if at all.  If we are not able to secure additional funding when needed, we may have to delay, reduce the scope of or eliminate selling and marketing activities or research and development programs.

In addition, we expect to use our capital to fund research and development and to make capital expenditures to keep pace with the expansion of our research and development programs and to scale up our commercial operations. The amount and timing of actual expenditures may vary significantly depending upon a number of factors, such as the progress of our product development, regulatory requirements, commercialization efforts, and the amount of cash used by operations. We expect that we will continue to generate revenue through our pharmacogenomic testing services and through ResponseDX testing services business provided to pharmaceutical clients and to the users of our ResponseDX testing services which partially include oncologists, hospitals, and cancer care centers.  These revenues are not guaranteed and are not expected to substantially offset the costs associated with our expansion efforts.
 
Following is a summary of recent events and the expected impact these events may or have had on our liquidity and future realization of revenues.
 
 
24

 
 
Recent contract amendments
 
In January 2010, we amended our agreement with Taiho and the agreement was renewed for an additional three years. According to the terms of the renewal, Taiho’s appointment as an exclusive purchaser in Japan of tests and testing services and its minimum purchasing obligations were extended through 2010.

Private placements
 
Under the Company’s Articles of Incorporation, the Company has one class of common stock and its holders have no preemptive, subscription, redemption or conversion rights.  For the periods ending December 31, 2010 and March 31, 2011 the Company did not sell any shares of its common stock.
 
Common stock classified outside of stockholders’ equity (deficit)

On July 22, 2009, we entered into a Purchase Agreement with certain funds of Lansdowne Partners Limited for the private placement of 3,057,907 newly-issued shares of the Company's common stock at a per share price of $1.30. The closing of the sale of the Shares occurred on July 23, 2009. The aggregate offering price of the shares was approximately $4 million.  In connection with the acquisition of the Shares, the Purchasers were granted certain preemptive rights permitting them to maintain their percentage ownership interests in connection with future issuances of the Company’s capital stock, subject to various exceptions and limitations. We received the funds on July 23, 2009.
 
Pursuant to the Lansdowne Registration Rights Agreement which is dated July 22, 2009, the Company filed a registration statement with the SEC to register the 3,057,907 shares sold to Lansdowne for resale, which became effective on November 3, 2009 and which registration statement is currently effective.
 
Under the Lansdowne Registration Rights Agreement, the Company was required to have the registration statement declared effective within 120 days after the private placement closed.  In addition, the Company is obligated to use commercially reasonable efforts (i) to cause the registration statement described above to remain continuously effective and (ii) to maintain the listing of the Company’s common stock on Nasdaq or other exchanges, as defined, for a period that that will terminate on the earlier of July 22, 2012 or the date on which Lansdowne has sold all of its shares of common stock.  The Company is also required to file with the SEC in a timely manner all reports and other documents required of the Company under the 1934 Act. In the event the Company fails to satisfy its obligations under the Lansdowne Registration Rights Agreement, the Company would be in breach of said agreement, in which event Lansdowne would be entitled to pursue all rights and remedies at law or equity including an injunction or other equitable relief.  The Lansdowne Registration Rights Agreement does not provide an explicitly stated or defined penalty due upon a breach.  Because (i) the potential penalty for any breach of the Lansdowne Registration Rights Agreement is not explicitly stated or defined, which prohibits the Company from applying the guidance of ASC 825-20-15, Registration Payment Arrangements and (ii) complying will all filing requirements under the 1934 Act as described above is not solely within the Company’s control, the Company is required to present Lansdowne’s investment of $3,975,279 in the Company’s common stock as common stock outside of stockholders’ equity in the accompanying consolidated balance sheet under ASC 480-10-S99-3, Classification and Measurement of Redeemable Securities.
 
On March 5, 2010, we entered into a Purchase Agreement with certain affiliates of and funds managed by Lansdowne Partners Limited Partnership, Greenway Capital Partners and Paragon Associates for the private placement of 3,005,349 newly-issued shares of our common stock at a per share price of $1.31.  The closing of the sale of the shares occurred on Friday, March 5, 2010.  In connection with the acquisition of the shares, the Purchasers were granted certain preemptive rights permitting them to maintain their percentage ownership interests in connection with future issuances of our capital stock, subject to various exceptions and limitations.  Lansdowne participated in the Private Placement by electing to exercise the preemptive rights granted to it pursuant to the Purchase Agreement by and between the Company and Lansdowne, dated July 22, 2009. Net proceeds received from this financing were approximately $3,879,403.
 
 
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In connection with the Private Placement, we also entered into a Registration Rights Agreement, dated March 5, 2010, with the Purchasers (the “Registration Rights Agreement”) pursuant to which it has agreed to file, within 45 days of the closing of the Private Placement, a registration statement with the SEC to register the shares for resale, which registration statement is required to become effective within 120 days following the closing.  We also granted certain "piggyback" registration rights to the Purchasers which are triggered if we propose to file a registration statement for its own account or the account of one or more shareholders until the earlier of the sale of all of the shares or the shares become eligible for sale under Rule 144(b)(1) without restriction.
 
Under the Registration Rights Agreements with the Purchasers, the Company is obligated to use commercially reasonable efforts to (i) cause the registration statements described above to remain continuously effective and (ii) to maintain the listing of Company’s common stock on Nasdaq or other exchanges, as defined, for a period that will terminate on the earlier of March 5, 2013 or the date on which the Purchases have sold all shares of common stock.  The Company is also required to file with the SEC in a timely manner all reports and other documents required of the Company required of the Company under the 1934 Act.  In the event the Company fails to satisfy its obligations under the registration rights agreements, the Company would be in breach of said agreements, in which event, the Purchases would be entitled to pursue all rights and remedies at law or equity including an injunction or other equitable relief. These registration rights agreements do not provide an explicitly stated or defined penalty due upon a breach.  Because (i) the potential penalty for any breach of these Registration Rights Agreement is not explicitly stated or defined, which prohibits the Company from applying the guidance of ASC 825-20-15, Registration Payment Arrangements and (ii) complying with all filing requirements under the 1934 Act as described above is not solely within the Company’s control, the Company  is required to present the investment of $3,879,403 in the Company’s common stock as common stock outside of stockholders’ equity in the accompanying consolidated balance sheet under ASC 480-10-S99-3, Classification and Measurement of Redeemable Securities.

Comparison of Cash Flows for the Three Months Ended March 31, 2011 and 2010
 
As of March 31, 2011, we had $1,924,367 in cash and cash equivalents, working capital of $3,693,307 and an accumulated deficit of $44,074,053.
 
Cash flows provided by operating activities
 
During the three months ended March 31, 2011, the Company used cash flows in operating activities of $1,996,743 compared to $1,737,948 used in the three months ended March 31, 2010.  The reasons for the increase in cash used in operating activities of $258,795 was due mainly to the decrease in accrued expenses and accounts payable.
 
The increase in accounts receivable of $1,507,520 related in part to an increase in revenue for the quarter from the Company’s pharmaceutical clients. In addition, our collections of aged accounts receivables from our established pharmaceutical clients were significantly less than in previous quarters. These receivables are expected to be collected in the second quarter of 2011.
 
The decrease in deferred revenue related to a decrease in advance billings to our customers, along with recognition of deferred revenue totaling $428,574.
 
Cash flows used in investing activities
 
Net cash used in investing activities was $172,585 for the three months ended March 31, 2011 and $96,153 for the three months ended March 31, 2010.  This increase was attributable to the additional need for property and equipment purchases in our laboratory and facility.
 
Cash flows used in financing activities
 
Cash flows from financing activities for the three months ended March 31, 2011 provided net cash of $5,411 relating to the sale of common stock and the exercise of stock options.  Cash flows from financing activities for the three months ended March 31, 2010 provided net cash of $3,879,403 relating to the sale of common stock and a capital contribution.  
 
Off-Balance Sheet Arrangements
 
We do not have any off-balance sheet arrangements.
 
 
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Recent Accounting Pronouncements
 
In January 2010, the FASB issued ASU 2010-06, Improving Disclosures about Fair Value Measurements, amends FASB ASC 820-10, Fair Value Measurements and Disclosures, and requires new disclosures about transfers into and out of Level 1 and 2 of the fair value hierarchy and separate disclosures about purchases, sales, issuances, and settlements relating to Level 3 measurements.  It is effective for interim and annual reporting periods beginning after December 15, 2009, except for the Level 3 measurement disclosures, which are effective for fiscal years beginning after December 15, 2010, and for interim periods within those fiscal years.  Early adoption is permitted. The adoption of this guidance did not have a material effect on our results of operations or financial position.

In April 2010, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2010-17, “Revenue Recognition — Milestone Method (Topic 605): Milestone Method of Revenue Recognition”. This ASU provides guidance on defining a milestone and determining when it may be appropriate to apply the milestone method of revenue recognition. Consideration that is contingent on achievement of a milestone in its entirety may be recognized as revenue in the period in which the milestone is achieved only if the milestone is judged to meet certain criteria to be considered substantive. The updated guidance is effective on a prospective basis for milestones achieved in fiscal years, and interim periods within those years, beginning on or after June 15, 2010. Entities may elect to adopt the amendments in the ASU retrospectively for all prior periods. The Company does not expect the adoption of these provisions to have a material effect on its consolidated financial statements.

In October 2009, the FASB issued ASU No. 2009-13, Revenue Recognition (Topic 605)—Multiple-Deliverable Revenue Arrangements: a consensus of the FASB Emerging Issues Task Force (ASU 2009-13). ASU 2009-13 establishes a selling-price hierarchy for determining the selling price of each element within a multiple-deliverable arrangement. Specifically, the selling price assigned to each deliverable is to be based on vendor-specific objective evidence (VSOE) if available, third-party evidence, if VSOE is unavailable, and estimated selling prices if neither VSOE or third-party evidence is available. In addition, ASU 2009-13 eliminates the residual method of allocating arrangement consideration and instead requires allocation using the relative selling price method. ASU 2009-13 will be effective prospectively for multiple-deliverable revenue arrangements entered into, or materially modified, in fiscal years beginning on or after June 15, 2010. The adoption of this guidance did not have a material effect on our results of operation or financial position.
 
 
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ITEM 3. Qualitative and Quantitative Disclosures about Market Risk.
 
Not applicable as we are a smaller reporting company.
 
ITEM 4. Controls and Procedures.
 
Our principal executive officer and principal financial officer, after evaluating the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this Quarterly Report on Form 10-Q, have concluded that, based on such evaluation, our disclosure controls and procedures were adequate and effective. In designing and evaluating our disclosure controls and procedures, our management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
 
There were no changes in our internal control over financial reporting during the quarter ended March 31, 2011 that have materially affected, or are reasonably likely to materially affect, our internal controls over financial reporting.
 
PART II. OTHER INFORMATION
 
ITEM 1. Legal Proceedings.
 
The Company is, from time to time, involved in legal proceedings, regulatory actions, claims and litigation arising in the ordinary course of business. These matters are not expected to have a material adverse effect upon the Company’s financial statements.
 
ITEM 1A. Risk Factors
 
Not applicable as we are a smaller reporting company.
 
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds.
 
None.
 
 
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ITEM 3. Defaults Upon Senior Securities.
 
None.
 
ITEM 4. (Removed and Reserved)
 
ITEM 5. Other Information.
 
None.
31.1
Certification of Principal Executive Officer Pursuant to Section 302.
   
31.2
Certification of Principal Financial Officer Pursuant to Section 302.
   
32
Section 906 certification of periodic financial report by Chief Executive Officer and Chief Financial Officer.
 
 
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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 thereunto duly authorized.
 
 
RESPONSE GENETICS, INC.
     
DATE: May 12, 2011
By:  
/s/ Kathleen Danenberg
 
Kathleen Danenberg
 
Chief Executive Officer (Principal Executive Officer)
     
DATE: May 12, 2011
By:  
/s/ David O’Toole
 
David O’Toole
 
Chief Financial Officer (Principal Financial Officer)
 
 
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