Attached files
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EX-32 - RESPONSE GENETICS INC | v184747_ex32.htm |
EX-10.1 - RESPONSE GENETICS INC | v184747_ex10-1.htm |
EX-31.2 - RESPONSE GENETICS INC | v184747_ex31-2.htm |
EX-31.1 - RESPONSE GENETICS INC | v184747_ex31-1.htm |
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, 2010
¨
|
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 May
14, 2010, there were 18,302,532 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, 2009 and March 31, 2010
(Unaudited)
|
1
|
||||
Unaudited
Consolidated Statements of Operations— Three months ended March 31, 2009
and 2010
|
2
|
||||
Unaudited
Consolidated Statements of Cash Flow — Three months ended March 31, 2009
and 2010
|
3
|
||||
Notes
to Unaudited Consolidated Financial Statements
|
4 -
24
|
||||
Item
2.
|
Management’s
Discussion and Analysis of Financial Condition and Results of
Operation
|
25
|
|||
Item
3.
|
Qualitative
and Quantitative Disclosures About Market Risk
|
34
|
|||
Item
4T.
|
Controls
and Procedures
|
34
|
|||
Part
II.
|
Other
Information
|
||||
Item
1.
|
Legal
Proceedings
|
34
|
|||
Item
2.
|
Unregistered
Sales of Equity Securities and Use of Proceeds
|
34
|
|||
Item
3.
|
Defaults
Upon Senior Securities
|
35
|
|||
Item
4.
|
Submission
of Matters to a Vote of Security Holders
|
35
|
|||
Item
5.
|
Other
Information
|
35
|
|||
Item
6.
|
Exhibits
|
35
|
|||
Signatures
|
|||||
Exhibit
Index
|
|||||
EX-10.1
|
|||||
EX-31.1
|
|||||
EX-31.2
|
|||||
EX-32
|
ii
RESPONSE
GENETICS, INC.
CONSOLIDATED
BALANCE SHEETS
December 31,
2009
|
March 31,
2010
|
|||||||
|
(Unaudited)
|
|||||||
ASSETS
|
||||||||
Current
assets
|
||||||||
Cash
and cash equivalents
|
$
|
7,058,365
|
$
|
9,091,246
|
||||
Accounts
receivable, net
|
1,982,951
|
2,486,132
|
||||||
Prepaid
expenses and other current assets
|
418,289
|
456,662
|
||||||
Total
current assets
|
9,459,605
|
12,034,040
|
||||||
Property
and equipment, net
|
1,253,714
|
1,265,486
|
||||||
Other
assets
|
79,655
|
84,655
|
||||||
Total
assets
|
$
|
10,792,974
|
$
|
13,384,181
|
||||
LIABILITIES,
COMMON STOCK CLASSIFED OUTSIDE OF STOCKHOLDERS’ EQUITY (DEFICIT) AND
STOCKHOLDERS’ EQUITY (DEFICIT)
|
||||||||
Current
liabilities
|
||||||||
Accounts
payable
|
$
|
729,100
|
$
|
1,006,142
|
||||
Accrued
expenses
|
503,612
|
738,686
|
||||||
Accrued
royalties
|
455,995
|
578,196
|
||||||
Accrued
payroll and related liabilities
|
468,774
|
878,858
|
||||||
Deferred
revenue
|
2,596,066
|
2,547,457
|
||||||
Total
current liabilities
|
4,753,547
|
5,749,339
|
||||||
Deferred
revenue, net of current portion
|
1,414,928
|
1,118,760
|
||||||
Total
liabilities
|
6,168,475
|
6,868,099
|
||||||
Commitments
and contingencies (Note 6)
|
||||||||
Common
stock classified outside of stockholders’ equity (deficit) (Note
15)
|
3,975,279
|
7,854,682
|
||||||
Stockholders’
equity (deficit)
|
||||||||
Common
stock, $0.01 par value; 50,000,000 shares authorized; 15,297,183 and
18,302,532 shares issued and outstanding at December 31, 2009
and March 31, 2010, respectively
|
122,393
|
122,393
|
||||||
Additional
paid-in capital
|
39,858,986
|
39,978,132
|
||||||
Accumulated
deficit
|
(39,146,784
|
)
|
(41,241,329
|
)
|
||||
Accumulated
other comprehensive loss
|
(185,375
|
)
|
(197,796
|
)
|
||||
Total
stockholders’ equity (deficit)
|
649,220
|
(1,338,600)
|
||||||
Total
liabilities and stockholders’ equity (deficit)
|
$
|
10,792,974
|
$
|
13,384,181
|
RESPONSE
GENETICS, INC.
UNAUDITED
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months
Ended March 31,
|
||||||||
|
2009
|
2010
|
||||||
Net
Revenue
|
$
|
1,537,226
|
$
|
3,696,908
|
||||
Operating
expenses:
|
||||||||
Cost
of revenue
|
1,274,764
|
2,133,808
|
||||||
Selling
and marketing
|
730,239
|
1,415,871
|
||||||
General
and administrative
|
1,749,611
|
1,659,308
|
||||||
UK
expenses
|
503,980
|
3,405
|
||||||
Research
and development
|
554,238
|
572,184
|
||||||
Total
operating expenses
|
4,812,832
|
5,784,576
|
||||||
Operating
loss
|
(3,275,606
|
)
|
(2,087,668
|
)
|
||||
Other
income (expense):
|
||||||||
Interest
expense
|
(3,427
|
)
|
(3,866
|
)
|
||||
Interest
income
|
16,705
|
99
|
||||||
Other
|
—
|
(1,854
|
)
|
|||||
Loss
before provision for income taxes
|
(3,262,328)
|
(2,093,289)
|
||||||
Provision
for income taxes
|
—
|
1,256
|
||||||
Net
loss
|
$
|
(3,262,328
|
)
|
$
|
(2,094,545
|
)
|
||
Unrealized
loss on foreign currency translation
|
(22,126
|
)
|
(12,421
|
)
|
||||
Total
comprehensive loss
|
$
|
(3,284,454
|
)
|
$
|
(2,106,966
|
)
|
||
Net
loss per share — basic and diluted
|
$
|
(0.30
|
)
|
$
|
(0.13
|
)
|
||
Weighted-average
shares — basic and diluted
|
10,905,943
|
16,198,788
|
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,
|
||||||||
|
2009
|
2010
|
||||||
Cash
flows from operating activities:
|
||||||||
Net
loss
|
$
|
(3,262,328
|
)
|
$
|
(2,094,545
|
)
|
||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||
Depreciation
and amortization
|
75,293
|
82,527
|
||||||
Share-based
compensation
|
315,134
|
119,146
|
||||||
Bad
debt expense
|
—
|
104,414
|
||||||
Loss
on sale of property and equipment
|
—
|
1,854
|
||||||
Changes
in operating assets and liabilities:
|
||||||||
Accounts
receivable
|
1,261,024
|
(607,595)
|
||||||
Prepaid
expenses and other current assets
|
(47,356
|
)
|
(43,373
|
)
|
||||
Accounts
payable
|
404,633
|
277,042
|
||||||
Accrued
expenses
|
438,988
|
235,074
|
||||||
Accrued
royalties
|
82,567
|
122,201
|
||||||
Accrued
payroll and related liabilities
|
260,941
|
410,084
|
||||||
Deferred
revenue
|
(766,756
|
)
|
(344,777
|
)
|
||||
Net
cash used in operating activities
|
(1,237,860)
|
(1,737,948
|
)
|
|||||
Cash
flows from investing activities:
|
||||||||
Purchase
of property and equipment
|
(117,829
|
)
|
(96,153
|
)
|
||||
Net
cash used in investing activities
|
(117,829
|
)
|
(96,153
|
)
|
||||
Cash
flows from financing activities:
|
||||||||
Net
proceeds from issuance of common stock
|
2,000,000
|
3,879,403
|
||||||
Net
cash provided by financing activities
|
2,000,000
|
3,879,403
|
||||||
Effect
of foreign exchange rates on cash and cash equivalents
|
(23,921
|
)
|
(12,421
|
)
|
||||
Net
increase in cash and cash equivalents
|
620,390
|
2,032,881
|
||||||
Cash
and cash equivalents:
|
||||||||
Beginning
of period
|
9,545,000
|
7,058,365
|
||||||
End
of period
|
$
|
10,165,390
|
$
|
9,091,246
|
||||
Cash
paid during the period for:
|
||||||||
Income
taxes
|
$
|
—
|
$
|
—
|
||||
Interest
|
$
|
3,427
|
$
|
3,866
|
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. In November 2006, the Company 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
have closed our subsidiary in Edinburgh. See Note 14 “U.K.
OPERATIONS”.
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 by providing pharmacogenomic testing services to pharmaceutical
companies in the United States, Asia and Europe and from the sale of the
Company’s ResponseDX diagnostic testing products.
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.
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, 2008 and 2009 consolidated financial statements
and accompanying notes included in the Company’s Form 10-K 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.
4
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
2.
Summary of Significant Accounting Policies - (continued)
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.
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, 2009 and March 31,
2010 amounted to $1,088,511 and $1,524,376,
respectively. There were no allowances for doubtful accounts recorded
against these accounts receivable at December 31, 2009 and March 31,
2010.
ResponseDX Accounts
Receivable
ResponseDX
accounts receivable related to Medicare billings 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. NeoGenomics Laboratories, a clinical reference
laboratory authorized to offer our tests, billings are based on their
established billing rates. Management performs ongoing evaluations of account
receivable balances based on management’s evaluation of historical experience
and current industry trends. Management believes that no allowance for doubtful
accounts is currently needed. Although the Company expects to collect amounts
due, actual collections may differ materially from estimated amounts. During the
three months ended March 31, 2009 and 2010, the Company recorded bad debt
expense of $0 and 104,414, respectively.
ResponseDX
accounts receivable as of December 31, 2009 and March 31, 2010, consisted of the
following:
December
31,
2009
|
March
31,
2010
|
|||||||
(Unaudited)
|
||||||||
Gross
Medicare receivable
|
$ | 4,139,471 | $ | 3,727,382 | ||||
Less
Medicare contractual allowances
|
(3,366,572 | ) | (2,871,978 | ) | ||||
Net
Medicare accounts receivable
|
772,899 | 855,404 | ||||||
NeoGenomics
Laboratories accounts receivable
|
109,768 | 100,126 | ||||||
Other
|
11,272 | 6,226 | ||||||
Net
ResponseDX accounts receivable
|
$ | 893,939 | $ | 961,756 |
Currently,
we recognize ResponseDX revenue from third party and private payors on a cash
basis until a collection history can be determined. Until we are reasonably
assured about a pattern of collections, we will continue to record revenues from
third party payors of ResponseDX on a cash basis.
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 method 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. During the year ended December 31, 2009 and the three month
period ended March 31, 2010, the Company has capitalized costs related to
database software development (see Note 3 in the accompanying consolidated
financial statements). The Company has not yet placed this database into service
and accordingly has not depreciated these software development costs. The
Company intends to place the database software into service and amortize those
costs beginning in late 2010 or early 2011 in accordance with ASC 350-40, Internal-Use Software,
(formerly SOP 98-1) and the amortization period will be three years using the
straight line method.
Revenue
Recognition
Revenues
are derived from pharmacogenomic testing services provided to pharmaceutical
companies and are recognized on a contract specific basis pursuant to the terms
of the related agreements. Revenue is recognized in accordance with SEC Staff
Accounting Bulletin No. 104, 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)
collectibility 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.
The
Company recognizes a portion of product revenue from its ResponseDX tests
invoiced to Medicare and NeoGenomics Laboratories on an accrual basis and to
third-party payors, including private payors on a cash basis. 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. ResponseDX revenues
related to NeoGenomics Laboratories billings are based on their established
billing rates. The Company recognizes revenue from third party and
private payors currently on a cash basis until a collection history can be
determined. Until a pattern of collections is reasonably assured, the Company
will continue to record revenues from third party payors of ResponseDx on a cash
basis.
6
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
2.
Summary of Significant Accounting Policies - (continued)
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.
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.
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, 2009 and March 31, 2010, 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. In March 2005, the SEC issued Staff Accounting Bulletin No.
107 (“SAB 107”) regarding the SEC’s interpretation of ASC 718 and the valuation
of share-based payments for public companies. The Company has applied the
provisions of SAB No. 107 in its adoption of ASC 718.
The
Company accounts for equity instruments issued to non-employees in accordance
with ASC 505, Equity,
(formerly EITF 96-18). 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.
7
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
2.
Summary of Significant Accounting Policies - (continued)
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, 2009 and March
31, 2010, and for the three months ended March 31, 2009 and 2010.
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
17.
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, 2009
and 2010 were $74,706 and $146,301, 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.
8
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 consist of financial instruments that potentially subject the
Company to concentrations of credit risk to the extent recorded on the balance
sheets. The Company maintains cash in United States financial institutions. As
March 31, 2010, the Company had two accounts which exceeded the insurance limits
of the Federal Deposit Insurance Corporation by a total of approximately
$3,600,000. 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, 2010, the Company had $4,940,452 of cash in
money market instruments and has not incurred any losses on these cash
balances. At March 31, 2010, approximately $225,988 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,
|
||||||||||||||||
2009
|
2010
|
|||||||||||||||
(Unaudited)
|
||||||||||||||||
Revenue
|
Percent of
Total
Revenue
|
Revenue
|
Percent of
Total
Revenue
|
|||||||||||||
Taiho
Pharmaceutical
|
$
|
399,375
|
26
|
%
|
|
$
|
*
|
*
|
||||||||
GlaxoSmithKline
and GlaxoSmithKline Biologicals
|
$
|
766,756
|
50
|
%
|
$
|
1,573,434
|
43%
|
|||||||||
Medicare,
net of contractual allowances
|
$
|
*
|
*
|
$
|
906,785
|
25%
|
* Less
than 10%
Customers
that account for greater than 10 percent of accounts receivable are provided
below.
As of December 31, 2009
|
As of March 31, 2010
|
|||||||||||||||
(Unaudited)
|
||||||||||||||||
Receivable
Balance
|
Percent of
Total
Receivables
|
Receivable
Balance
|
Percent of
Total
Receivables
|
|||||||||||||
Taiho Pharmaceutical
|
$
|
263,725
|
13%
|
|
$
|
*
|
*
|
|||||||||
GlaxoSmithKline
and GlaxoSmithKline Biologicals
|
$
|
771,618
|
39%
|
$
|
1,228,657
|
49%
|
||||||||||
Medicare,
net of contractual allowances
|
$
|
772,899
|
39%
|
$
|
855,404
|
34%
|
* Less
than 10%
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 – (continued)
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 7 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 65% and 70% of
the Company’s reagent purchases for the three month periods ended March 31, 2009
and 2010, respectively.
Recent
Accounting Pronouncements
In
December 2009, the Financial Accounting Standards Board ("FASB") issued
Accounting Standards Update ("ASU") 2009-17, Consolidations (Topic 810) —
Improvements to Financial Reporting by Enterprises Involved with Variable
Interest Entities (“ASU 2009-17”). ASU 2009-17 codifies SFAS 167, Amendments to
FASB Interpretation No. 46(R), and amends the consolidation guidance related to
a variable interest entity (“VIE”). Primarily, the current quantitative analysis
used under ASC 810, Consolidations, will be eliminated and replaced with a
qualitative approach that is focused on identifying the variable interest that
has the power to direct the activities that most significantly impact the
performance of the VIE and absorb losses or receive returns that could
potentially be significant to the VIE. In addition, this new accounting standard
will require an ongoing reassessment of the primary beneficiary of the VIE,
rather than reassessing the primary beneficiary only upon the occurrence of
certain pre-defined events. ASU 2009-17 will be effective as of the beginning of
the annual reporting period that begins after November 15, 2009, and requires
the reconsideration of all VIEs for consolidation in which an entity has a
variable interest upon the effective date of these amendments. The adoption of
this guidance is not expected to have a material effect on our results of
operations or financial position.
In
January 2010, the FASB issued ASU No. 2010-06, Fair Value Measurements and
Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements
(“ASU 2010-06”). ASU 2010-06 requires new disclosures and clarifies existing
disclosure requirements about fair value measurement as set forth in
Codification Subtopic 820-10. ASU 2010-06 amends Codification Subtopic 820-10 to
now require that (1) a reporting entity must disclose separately the amounts of
significant transfers in and out of Level 1 and Level 2 fair value measurements
and describe the reasons for the transfers; (2) in the reconciliation for fair
value measurements using significant unobservable inputs, a reporting entity
should present separately information about purchases, sales, issuances, and
settlements and (3) a reporting entity should provide disclosures about the
valuation techniques and inputs used to measure fair value for both recurring
and nonrecurring fair value measurements. ASU 2010-06 is effective for interim
and annual reporting periods beginning after December 15, 2009, except for the
disclosures about purchases, sales, issuances, and settlements in the roll
forward of activity in Level 3 fair value measurements. Those disclosures are
effective for fiscal years beginning after December 15, 2010, and for interim
periods within those fiscal years. The adoption of this guidance is not expected
to have a material effect on our results of operations or financial
position.
In
February 2010, the FASB issued ASU 2010-09, Subsequent Events (Topic 855)
Amendments to Certain Recognition and Disclosure Requirements, which amends
disclosure requirements within Subtopic 855-10. An entity that is an SEC filer
is not required to disclose the date through which subsequent events have been
evaluated. This change alleviates potential conflicts between Subtopic 855-10
and the SEC's requirements. ASU 2010-09 is effective upon issuance.
The adoption of ASU 2010-09 did not have a material impact on our consolidated
financial statements.
In April 2010, the FASB
issued Accounting Standard Codification ("ASC") update 2010-12 to ASC 740-10,
“Income taxes.” On March 30, 2010, the President signed the Health Care and
Education Reconciliation Act of 2010, which is a reconciliation bill that amends
the Patient Protection and Affordable Care Act that was signed by the President
on March 23, 2010 (collectively the "Acts"). Recently, questions have
arisen about the effect, if any, that the different signing dates might have on
the accounting for these two Acts. This timing difference, related solely to the
signing dates, should not have an impact on a majority of registrants because
the Acts were both signed within a relatively short time period, which for the
vast majority of companies falls into the same reporting period. After
consultation with the FASB staff, the Office of the Chief Accountant would not
object to a view that the two Acts should be considered together for accounting
purposes. The Company is currently assessing any impact these Acts
will have on its consolidated financial statements and will treat them as one
for accounting purposes under this assessment.
10
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
3.
Property and Equipment
Property
and equipment consists of the following:
December 31,
2009
|
March 31,
2010
|
|||||||
(Unaudited)
|
||||||||
Laboratory
equipment
|
$
|
2,321,628
|
$
|
2,324,579
|
||||
Furniture
and equipment
|
549,271
|
612,188
|
||||||
Leasehold
improvements
|
188,509
|
194,899
|
||||||
Software
development
|
371,872
|
371,872
|
||||||
Total
|
3,431,280
|
3,503,538
|
||||||
Less:
Accumulated depreciation and amortization
|
(2,177,566
|
)
|
(2,238,052
|
)
|
||||
Total
property and equipment, net
|
$
|
1,253,714
|
$
|
1,265,486
|
Depreciation
expense, included in cost of revenue, general and administrative expenses, and
research and development expenses for the three month periods ended March 31,
2009 and 2010 was $75,293 and $82,527, respectively.
4.
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consists of the following:
December 31,
2009
|
March 31,
2010
(Unaudited)
|
|||||||
Prepaid
insurance
|
$
|
100,213
|
$
|
103,438
|
||||
Prepaid
maintenance contracts
|
162,695
|
213,977
|
||||||
Other
|
155,381
|
139,247
|
||||||
|
$
|
418,289
|
$
|
456,662
|
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
5.
Loss Per Share
The
Company calculates net loss per share in accordance with ASC 260, Earnings Per Share, (formerly
SFAS No. 128). 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,
|
||||||||
|
2009
|
2010
|
||||||
(Unaudited)
|
||||||||
Numerator:
|
||||||||
Net
loss
|
$
|
(3,262,328
|
)
|
$
|
(2,094,545
|
)
|
||
Numerator
for basic and diluted earnings per share
|
$
|
(3,262,328
|
)
|
$
|
(2,094,545
|
)
|
||
Denominator:
|
||||||||
Denominator
for basic and diluted earnings per share — weighted-average
common shares
|
10,905,943
|
16,198,788
|
||||||
Basic
and diluted loss per share
|
$
|
(0.30
|
)
|
$
|
(0.13
|
)
|
Outstanding
stock options and warrants to purchase 1,684,990 shares and 1,796,316 shares for
the three months ended March 31, 2009 and 2010, respectively, of which 100,000
warrants are included in these amounts for 2009 and 2010, were excluded from the
calculation of diluted loss per share as their effect would have been
antidilutive.
6.
Commitments and Contingencies
Operating
Leases
The
Company leases office and laboratory space under a noncancelable operating lease
that expires on March 31, 2011. 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. In March 2007, the Company entered into a noncancelable
operating lease, which expired in March 2009, for office and laboratory space in
Scotland. As a result of the reduction in workforce implemented by the Company
on February 9, 2009, the Company extended its lease in Scotland for one
additional month. For additional information see Note 14 U.K. Operations.
The Company also leases space at 103 South Carroll Street, Suite 2b, Fredrick,
Maryland 21701, for administrative purposes. This lease expires on August 31,
2010. Rent expense, included in cost of revenue, general and
administrative, and research and development, was $143,933 and $102,867 for the
three months ended March 31, 2009 and 2010, 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,
2010:
Year Ending December
31,
|
||||
Remainder
of 2010
|
$
|
343,575
|
||
2011
|
113,242
|
|||
Thereafter
|
—
|
|||
Total
|
$
|
456,817
|
12
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
6.
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, 2009 and March 31, 2010.
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.
13
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
7.
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 $17,574 and $96,562 for the three months ended March 31,
2009 and 2010, 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 $64,993 and $130,495 for the three months ended March 31,
2009 and 2010, 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, 2010, Roche has not been required to
pay any royalties to the Company pursuant to this agreement.
14
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
7.
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.
Taiho is
obligated to purchase a minimum amount of testing services from the Company each
calendar quarter. Revenue recognized under this agreement was $399,375 and
$307,925 for the three months ended March 31, 2009 and 2010,
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 $14,400 and $50,217 for the three months ended March 31,
2009, and 2010, respectively.
In
December 2008, the Company amended and restated our 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 for this agreement at March 31, 2010 is
$1,350,717, of which $1,028,248 related to 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 in April 2010
a non-refundable technology access fee in consideration for the transfer of the
Company’s technology to GSK. The Company recorded the access fee as revenue
during the three months ended March 31, 2010. The agreement also contains
milestone payments that require GSK to pay the Company additional amounts upon
certain actions performed by GSK.
15
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
7.
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 specifies that GSK Bio will
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 may now extend the term of the agreement for an additional one-year period
through December 31, 2011. In the event GSK Bio extends the term
through 2011, the then remaining balance of the existing credit shall be divided
into six equal quarterly amounts and apply to all services rendered to GSK Bio
in each of the last two quarters of 2010 and the four calendar quarters of
2011. If GSK Bio does not extend the term through 2011, the then
remaining balance of the existing credit will instead be divided into two equal
quarterly amounts and apply to all services rendered to GSK Bio in each of the
last two quarters of 2010. 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, 2009 and March 31, 2010 is $2,588,896 and $2,294,336,
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 $766,756 and $1,023,217 relating to the GSK Bio agreement
for the three months ended March 31, 2009, and 2010,
respectively, of which only $294,560 was recorded against the
deferred revenue balance during the three months ended March 31,
2010.
16
RESPONSE GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
7.
License and Collaborative Agreements - (continued)
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. For the three months ended March 31, 2009 and 2010, no
testing services were performed.
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, as provided in the agreement, collected from the Company's clients in
the Territory, for its testing services performed which totaled $328,868 and
$302,644 for the three months ended March 31, 2009 and 2010,
respectively.
17
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
8.
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, 2010. 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 shares in 2008, 2009, and 2010 resulting in the total number of shares
that may be issued as of January 1, 2010 to be 2,760,000. As of March 31, 2010,
there were 1,169,684 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 1,796,316 options outstanding at a weighted
average exercise price of $5.17 at March 31, 2010. There were 761,483 non-vested
stock options with a weighted average grant date fair value of $1.66 outstanding
at March 31, 2010.
The
following table summarizes the stock option activity for the three months ended
March 31, 2010:
Number of
Shares
|
Weighted
Average
Exercise
Price
|
Remaining
Contractual
Life (Years)
|
Aggregate
Intrinsic
Value
|
|||||||||||||
Outstanding,
December 31, 2009
|
1,956,490
|
$
|
5.12
|
7.52
|
—
|
|||||||||||
Granted
(Unaudited)
|
—
|
$
|
—
|
|||||||||||||
Exercised
(Unaudited)
|
—
|
$
|
—
|
|||||||||||||
Forfeited
(Unaudited)
|
(160,174)
|
$
|
4.57
|
|||||||||||||
Outstanding,
March 31, 2010 (Unaudited)
|
1,796,316
|
$
|
5.17
|
7.18
|
$
|
30,966
|
||||||||||
Exercisable,
March 31, 2010 (Unaudited)
|
1,034,833
|
$
|
6.45
|
6.28
|
$
|
7,722
|
18
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
8.
Stock Option Plan - (continued)
There
were no options granted or exercised during the three months ended March 31,
2009 and 2010.
As of
March 31, 2010, there was $1,265,360 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 1.94 years.
Information
about stock-based compensation included in the results of operations for the
three months ended March 31, 2009 and 2010 are as follows:
Three Months Ended
March 31,
|
||||||||
(Unaudited)
|
||||||||
|
2009
|
2010
|
||||||
Cost
of revenue
|
$
|
64,570
|
$
|
33,578
|
||||
Research
and development
|
21,523
|
6,228
|
||||||
General
and administrative
|
229,041
|
79,340
|
||||||
Totals
|
$
|
315,134
|
$
|
119,146
|
9. 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. The
warrants expire in June 2012.
There
were no warrants granted during the three months ended March 31, 2009
and 2010. As of March 31, 2010, all of the warrants were outstanding
and exercisable and had a remaining contractual life of 2.25 years.
19
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
10.
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 2010.
11.
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. There were no amounts paid
to Mrs. Danenberg for the three months ended March 31, 2009. For the
three months ended March 31, 2010, Mrs. Danenberg was paid $14,593.
20
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
12.
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:
|
2009
|
2010
|
||||||
(Unaudited)
|
||||||||
United
States
|
$
|
371,095
|
$
|
2,365,766
|
||||
Europe
|
766,756
|
1,023,217
|
||||||
Japan
|
399,375
|
307,925
|
||||||
|
$
|
1,537,226
|
$
|
3,696,908
|
Long-lived
assets:
|
December
31,
2009
|
March
31,
2010
(Unaudited)
|
||||||
United
States
|
$
|
1,253,714
|
$
|
1,265,486
|
13. Net
ResponseDX Revenue
Net
ResponseDX revenue for the three months ended March 31, 2009 and 2010 were
comprised of the following:
Three
Months Ended March 31,
|
||||||||
2009
|
2010
|
|||||||
(Unaudited)
|
||||||||
Gross
Medicare revenue
|
$
|
313,305
|
$
|
2,870,356
|
||||
Medicare
contractual allowances
|
(208,869
|
)
|
(1,963,571)
|
|||||
Net
Medicare revenue
|
104,436
|
906,785
|
||||||
NeoGenomics
Laboratories revenue
|
73,947
|
90,685
|
||||||
Revenue
recognized on a cash basis
|
84,471
|
717,284
|
||||||
Other
|
—
|
5,496
|
||||||
Net
ResponseDX revenue
|
$
|
262,854
|
$
|
1,720,250
|
We
recognize a portion of product revenue from our ResponseDX tests invoiced to
Medicare and NeoGenomics Laboratories on an accrual basis and
to third-party payors, including private payors, on a cash
basis. 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. We recognize revenue from third
party and private payors currently on a cash basis until a collection history
can be determined. Until we are reasonably assured about a pattern of
collections we will continue to record revenues from third party payors of
ResponseDX on a cash basis. The Company began recording revenues for
ResponseDX during the quarter ended September 30, 2008.
21
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
13.
Net ResponseDX Revenue - (continued)
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.
14. U.K. Operations
In
December, 2008, the Company made the decision to increase the
operational efficiency of the Company by consolidating its U.K. operations
with its US operations. On February 9, 2009, the
Company implemented a reduction of workforce as part of a strategic plan to
increase operational efficiency in conjunction with the consolidation
of its services at its CLIA-certified laboratory facilities in Los
Angeles, which did not affect our genetic testing services or current
partnership agreements. As such, management concluded that the closure of
the U.K. operations did not constitute a discontinued operation. As a
result of the reduction of workforce, management performed a
recoverability test of the long-lived assets located at the United Kingdom
testing facility.
The lease
for the UK testing facility expired on April 1, 2009. and was
extended, pursuant to its terms, for an additional month, in order to facilitate
the winding down of the operations in the UK. The reduction of
workforce was substantially completed on March 31, 2009. The operating costs
related to the U.K. laboratory were $307,481 for the three months ended March
31, 2009. In addition, the Company incurred redundancy costs of
$196,499 in connection with the reduction of workforce. The operating
costs related to the U.K. laboratory were $3,405 for the three months ended
March 31, 2010.
15.
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 SEC to register the 2,000,000 shares for
resale, which registration statement became effective on June 30,
2009.
22
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
15. Private Placements –
(continued)
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 ("Lansdowne") 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
$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.
23
RESPONSE
GENETICS, INC.
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
15.
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
$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, 2009 and March 31, 2010, a total of $3,975,279 and $7,854,682 of
common stock was classified outside of stockholders’ equity
(deficit).
16.
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, 2010, 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, 2010:
Fair
Value Measurement as of March 31, 2010
|
||||||||||||||
Total
|
Level
1
|
Level
2
|
Level
3
|
|||||||||||
Description
|
$
|
$
|
$
|
$
|
||||||||||
Money
market accounts (1)
|
4,940,452
|
4,940,452
|
-
|
-
|
(1)
|
Included
in cash and cash equivalents on the accompanying consolidated balance
sheet.
|
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, 2010 and our audited financial statements for
the year ended December 31, 2009 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.
25
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.
On September 29, 2008, we announced an exclusive agreement with NeoGenomics
Laboratories (OTCBB: NGNM) whereby NeoGenomics will offer our proprietary
ResponseDx:Colon and ResponseDx: Lung tests nationwide. Under the terms of the
agreement NeoGenomics will be the national exclusive clinical reference
laboratory authorized to offer our proprietary tests through NeoGenomics
national sales force and our sales team. Currently, our recently formed sales
team has been expanded to 13 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 11.5% and 9.9% of our total operating
expenses for the three months ended March 31, 2009 and 2010, respectively. Major
components of the $572,184 in research and development expenses for the three
months ended March 31, 2010 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.
26
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.
We
recognize a portion of product revenue from our ResponseDX tests invoiced to
Medicare on an accrual basis and to third-party payors, including private
payors, on a cash 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 recognize revenue from
third party and private payors currently on a cash basis until a collection
history can be determined. Until we are reasonably assured about a pattern of
collections we will continue to record revenues from third party payors of
ResponseDX on a cash basis.
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 $17,574 and
$96,562 for the three months ended March 31, 2009 and 2010, 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
$64,993 and $130,495 for the three months ended March 31, 2009 and 2010,
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.
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
at either December 31, 2009 or March 31, 2010.
We bill
Medicare and third-party 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 third-party payors. As we continue to generate
revenues from ResponseDX, we will monitor the collection history from third
party payors. Until we are reasonably assured about a pattern of collections, we
will continue to record revenues from third party payors of ResponseDX on a cash
basis.
While we
have not had material credit losses prior to 2010, during the three months
ended March 31, 2010, we recorded bad debt expense of $104,414. 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, 2010 and March 31, 2009
Revenues:
Revenues were $3,696,908 for the quarter ended March 31, 2010, as
compared to $1,537,226 for the quarter ended March 31, 2009, an increase of
$2,159,862, or 140.5%. The increase was primarily due to increases in ResponseDX
revenues of $1,457,396, pharmaceutical revenues of $188,182 and the technology
access fee (see note 7 in the accompanying consolidated financial
statements). For the quarter ended March 31, 2010, ResponseDX revenue
accounted for 46.5% of total revenues as compared to 17.1% for the quarter ended
March 31, 2009. ResponseDX revenues for the quarter ended March 31,
2010, as compared to the quarter ended March 31, 2009, increased
554%. For the quarter ended March 31, 2010, our two most significant
pharmaceutical customers accounted for approximately 43% of our revenue, as
compared to approximately 76% of our revenue for the quarter ended March 31,
2009.
Cost of Revenues:
Cost of revenues for the quarter ended March 31, 2010 were
$2,133,808 as compared to $1,274,764 for the quarter ended March 31, 2009, an
increase of $859,044 or 67.4%. This increase resulted primarily from
increases in personnel and temporary help costs of $336,611, lab supplies and
reagent costs of $110,258, royalty costs of $144,490, consultation costs of
$51,530, recruiting costs of $112,202 and shipping costs of
$57,897. Cost of revenues as a percentage of revenues was 57.7% for
the quarter ended March 31, 2010, as compared to 82.9% for the quarter ended
March 31, 2009, a decrease of 25.2%. This decrease was primarily due to the
technology access fee, which had no costs associated with it.
28
Research and Development
Expenses: Research and development expenses were $572,184 for
the quarter ended March 31, 2010, as compared to $554,238 for the quarter ended
March 31, 2009, an increase of $17,946 or 3.2%. This increase
resulted primarily from increases in post doctorate personnel costs of $37,000,
research costs relating to the development of diagnostic kits of $37,000, and
recruiting costs of $21,038, offset by a decrease in patent legal costs of
$81,775. 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 totaled $1,659,308
for the quarter ended March 31, 2010, as compared to $1,749,611 for the quarter
ended March 31, 2009, a decrease of $90,303 or 5.2%. This decrease
resulted primarily from decreases in accounting service costs of $63,214, travel
costs of $103,557 and stock-based compensation expense of $149,701. These
decreases were offset by increases in personnel costs of $172,821 and bad
debt expenses of $104,414.
Sales and Marketing
Expenses: Sales and marketing expenses totaled $1,415,871 for
the quarter ended March 31, 2010, as compared to $730,239 for the quarter ended
March 31, 2009, an increase of $685,632 or 93.9%. The increase primarily
resulted from increased sales and marketing activities for ResponseDX, which
included increases in personnel costs of $346,088, marketing costs of $219,111,
travel and meeting costs of $60,064 and billing service costs of
$44,649. 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: In December,
2008, we made the decision to increase the operational efficiency of the Company
by consolidating our U.K. operations with our US operations. We
implemented a reduction of workforce as part of a strategic plan to increase
operational efficiency in conjunction with the consolidation of our
services at our Los Angeles facilities and such reduction did not
affect our genetic testing services or current partnership
agreements. As such, management concluded that the closure of the U.K.
operations did not constitute a discontinued operation. As a result of
the reduction of workforce, management performed a recoverability
test of the long-lived assets located at the United Kingdom testing
facility.
On
February 9, 2009, management implemented the reduction of workforce
pursuant to which the Company closed its UK testing facility to consolidate
services at its CLIA-certified laboratory facilities in Los Angeles. Our
lease for our UK testing facility expired on April 1, 2009. We
extended the lease, pursuant to its terms, for an additional month, in order to
facilitate the winding down of our operations in the UK. The
reduction of workforce was substantially completed on March 31,
2009. The operating costs related to our UK lab, which were
previously included in general and administrative expenses, were $3,405 for
the quarter ended March 31, 2010 compared to $307,481 for the same comparable
period in 2009. Additionally, in connection with the reduction of
workforce, we incurred expenses related to redundancy costs of
$196,499. These costs were recorded in the quarter ended March 31,
2009.
Interest
Income: Interest income was $99 for the quarter ended March
31, 2010, compared with $16,705 for the same period in 2009. This $16,606
decrease was due to lower rates of return during the period ending March 31,
2010.
Income Taxes: As of
March 31, 2010 and 2009, 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 $3,262,328 during the quarters ended March
31, 2010 and 2009, respectively. Since our inception in September 1999, we have
incurred cumulative losses and as of March 31, 2010, we had an accumulated
deficit of $41,241,329. 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 plans to
effectively manage cash flows in 2010 and expects that cash on the balance sheet
will be sufficient to meet current obligations. 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.
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.
30
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. As more fully described in Note 15 of the accompanying
consolidated financial statements, the Company sold shares of its common stock
during 2009 and 2010 in three private placements, as described
below. In connection with these private placements, the Company
entered into registration rights agreements with the purchasers of the common
shares.
On
February 27, 2009, we 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 Monday, March 2, 2009 and we received net
proceeds of $2,000,000 on the same date.
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 SEC to register the 2,000,000 shares for
resale, which registration statement became effective on June 30,
2009.
The
Special Situations Registration Rights Agreement provides an explicitly stated
or defined penalty due upon a breach, which allows the Company to apply the
guidance of ASC 825-20-15, Registration Payment
Arrangements and compliance with all filing requirements under the 1934
Act as described above was solely within the Company’s control. As
such, it allowed the Company to include the $2,000,000 as stockholders’ equity
in the accompanying balance sheet under ASC 480-10-S99-3, Classification and Measurement of
Redeemable Securities.
Common stock classified
outside of stockholders’ equity (deficit)
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.
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
$3,879,403.
31
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 Quarters Ended March 31, 2010 and 2009
As of
March 31, 2010, we had $9,091,246 in cash and cash equivalents, working capital
of $6,284,701 and an accumulated deficit of $41,241,329.
Cash
flows provided by operating activities
During
the quarter ended March 31, 2010, the Company used cash flows in operating
activities of $1,737,948 compared to $1,237,860 used in the quarter ended
March 31, 2009. The reasons for the increase in cash used in
operating activities of $500,088 was due mainly to the increase in accounts
receivable and decrease in deferred revenue, offset by the increases in accounts
payable and accrued expenses, accrued royalties and accrued payroll and the
decrease in net loss.
The increase
in accounts receivable of $607,595 related mainly to an increase in
Pharmaceutical accounts receivable, with a slight increase in ResponseDX
accounts receivable.
The
decrease in deferred revenue partially related to a decrease in advance
billings to our customers, along with recognition of deferred revenue
totaling $344,777.
The
increase in accounts payable and accrued expenses primarily resulted from
increased sales and marketing and business development activities related to the
launch of Response DX.
The
increase in accrued payroll and related liabilities is primarily due to accrued
bonuses at March 31, 2010.
Cash
flows used in investing activities
Net cash
used in investing activities was $96,153 for the quarter ended March 31, 2010
and $117,829 for the quarter ended March 31, 2009. This decrease was
attributable to reduced need for capital equipment purchases in our
laboratories.
Cash
flows used in financing activities
Cash
flows from financing activities for the quarter ended March 31, 2010
provided net cash of $3,879,403 relating to the sale of common
stock. Cash flows from financing activities for the quarter
ended March 31, 2009 provided net cash of $2,000,000 relating to the sale of
common stock.
32
Off-Balance
Sheet Arrangements
We do not
have any off-balance sheet arrangements.
Recent
Accounting Pronouncements
In
December 2009, the Financial Accounting Standards Board ("FASB") issued
Accounting Standards Update ("ASU") 2009-17, Consolidations (Topic 810) —
Improvements to Financial Reporting by Enterprises Involved with Variable
Interest Entities (“ASU 2009-17”). ASU 2009-17 codifies SFAS 167, Amendments to
FASB Interpretation No. 46(R), and amends the consolidation guidance related to
a variable interest entity (“VIE”). Primarily, the current quantitative analysis
used under ASC 810, Consolidations, will be eliminated and replaced with a
qualitative approach that is focused on identifying the variable interest that
has the power to direct the activities that most significantly impact the
performance of the VIE and absorb losses or receive returns that could
potentially be significant to the VIE. In addition, this new accounting standard
will require an ongoing reassessment of the primary beneficiary of the VIE,
rather than reassessing the primary beneficiary only upon the occurrence of
certain pre-defined events. ASU 2009-17 will be effective as of the beginning of
the annual reporting period that begins after November 15, 2009, and requires
the reconsideration of all VIEs for consolidation in which an entity has a
variable interest upon the effective date of these amendments. The adoption of
this guidance is not expected to have a material effect on our results of
operations or financial position.
In
January 2010, the FASB issued ASU No. 2010-06, Fair Value Measurements and
Disclosures (Topic 820): Improving Disclosures about Fair Value Measurements
(“ASU 2010-06”). ASU 2010-06 requires new disclosures and clarifies existing
disclosure requirements about fair value measurement as set forth in
Codification Subtopic 820-10. ASU 2010-06 amends Codification Subtopic 820-10 to
now require that (1) a reporting entity must disclose separately the amounts of
significant transfers in and out of Level 1 and Level 2 fair value measurements
and describe the reasons for the transfers; (2) in the reconciliation for fair
value measurements using significant unobservable inputs, a reporting entity
should present separately information about purchases, sales, issuances, and
settlements and (3) a reporting entity should provide disclosures about the
valuation techniques and inputs used to measure fair value for both recurring
and nonrecurring fair value measurements. ASU 2010-06 is effective for interim
and annual reporting periods beginning after December 15, 2009, except for the
disclosures about purchases, sales, issuances, and settlements in the roll
forward of activity in Level 3 fair value measurements. Those disclosures are
effective for fiscal years beginning after December 15, 2010, and for interim
periods within those fiscal years. The adoption of this guidance is not expected
to have a material effect on our results of operations or financial
position.
In
February 2010, the FASB issued ASU 2010-09, Subsequent Events (Topic 855)
Amendments to Certain Recognition and Disclosure Requirements, which amends
disclosure requirements within Subtopic 855-10. An entity that is an SEC filer
is not required to disclose the date through which subsequent events have been
evaluated. This change alleviates potential conflicts between Subtopic 855-10
and the SEC's requirements. ASU 2010-09 is effective upon issuance. The
adoption of ASU 2010-09 did not have a material impact on our consolidated
financial statements.
In April 2010, the FASB
issued Accounting Standard Codification ("ASC") update 2010-12 to ASC 740-10,
“Income taxes.” On March 30, 2010, the President signed the Health Care and
Education Reconciliation Act of 2010, which is a reconciliation bill that amends
the Patient Protection and Affordable Care Act that was signed by the President
on March 23, 2010 (collectively the "Acts"). Recently, questions have
arisen about the effect, if any, that the different signing dates might have on
the accounting for these two Acts. This timing difference, related solely to the
signing dates, should not have an impact on a majority of registrants because
the Acts were both signed within a relatively short time period, which for the
vast majority of companies falls into the same reporting period. After
consultation with the FASB staff, the Office of the Chief Accountant would not
object to a view that the two Acts should be considered together for accounting
purposes. The Company is currently assessing any impact these Acts
will have on its consolidated financial statements and will treat them as one
for accounting purposes under this assessment.
33
ITEM
3. Qualitative and Quantitative Disclosures about Market Risk.
Not
applicable as we are a smaller reporting company.
ITEM
4T. 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, 2010 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.
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.
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 will be required to present the investment of approximately
$3,879,403 in the Company’s common stock as common stock outside of
stockholders’ equity in its future filings.
34
ITEM
3. Defaults Upon Senior Securities.
None.
ITEM
4. Submission of Matters to a Vote of Security Holders.
None.
ITEM
5. Other Information.
None.
ITEM 6. Exhibits.
10.1
|
Non-exclusive
License Agreement between GlaxoSmithKline LLC and Response Genetics, Inc.
dated March 5, 2010*
|
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.
*
Portions of Exhibit 10.1 have been redacted, and the redacted portions
have been separately filed with the Securities and Exchange
Commission.
|
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 14, 2010
|
By:
|
/s/
Kathleen Danenberg
|
Kathleen
Danenberg
|
||
President
and Chief Executive Officer (Principal Executive
Officer)
|
||
DATE:
May 14, 2010
|
By:
|
/s/
David O’Toole
|
David
O’Toole
|
||
Chief
Financial Officer (Principal Financial
Officer)
|
35