Empresas y finanzas
Response Genetics Reports Full Year 2007 and Fourth Quarter Financial Results
Response Genetics, Inc. (NASDAQ: RGDX) a company focused on the
development of molecular diagnostic tests for cancer, today announced
its consolidated financial results for the twelve months ended
December 31, 2007 and the fourth quarter of 2007.
"During the fourth quarter of 2007, Response Genetics made great
strides to get the ERCC1 test ready for its first quarter 2008
launch," said Kathleen Danenberg, President and CEO of Response
Genetics. "I´m happy to report that not only did we launch ERCC1 in
March 2008, but we also expanded our test offerings in the form of
ResponseDX: Lung(TM) and ResponseDX: Colon(TM), which includes tests
for KRAS mutation status, RRM1 gene expression, EGFR amplification,
and TS gene expression. The added tests will give both physicians and
their patients invaluable information for planning their therapies for
non-small cell lung cancer and colorectal cancer. We look forward to
expanding the use of ResponseDX tests and further developing our
diagnostic pipeline."
Financial Results for Twelve Months Ended December 31, 2007
Total revenue increased by 30% to $7.8 million in the twelve
months ended 2007, compared to $6.0 million in the twelve months of
2006. This increase was primarily generated by the Company´s existing
pharmaceutical contracts related to pharmacogenomic testing services,
and the introduction of new testing services being offered by Response
Genetics to its pharmaceutical clients.
Cost of revenue for the twelve months ended in 2007 was $4.0
million compared with $2.5 million for the twelve months of 2006.
Research and development expenses were $2.5 million for the twelve
months of 2007, compared with $1.3 million for the same period in the
prior year. General and administrative expenses were $6.8 million for
the twelve months of 2007 compared to $4.0 million for the same period
in 2006. Total operating expenses for the twelve months of 2007
increased to $13.3 million, compared with $7.7 million for the same
period last year. The increases in operating expenses were primarily
due to: (1) non-cash, stock-based compensation to employees and new
personnel to support the Company´s growth totaled approximately $2.1
million, (2) operating costs related to the start up and continuing
operation of the European laboratory totaled approximately $1.5
million, (3) costs involving the new testing services the Company is
offering and additional reagents and supplies totaled approximately
$900,000, (4) increases in maintaining the Company´s intellectual
property portfolio, costs related to the completion of the Company´s
IPO, and costs associated with being a public company, additional
depreciation on fixed asset purchases all totaled approximately $1.1
million.
Response Genetics´ net loss for the twelve months ended 2007 was
$5.5 million or $0.78 per share, compared with a net loss of $2.3
million, or $0.84 per share, for the twelve months of 2006.
Financial Results for the Fourth Quarter Ended December 31, 2007
Total revenue increased by 11% to $2.4 million in the fourth
quarter of 2007, compared to $2.2 million in the fourth quarter of
2006. Cost of revenue for the fourth quarter of 2007 was $1,129,473,
compared with $834,169 for the fourth quarter of 2006. Research and
development expenses were $566,293 for the fourth quarter of 2007,
compared with $399,184 for the same period in the prior year. General
and administrative expenses of $1.8 million for the fourth quarter of
2007 increased from $1.7 million for the fourth quarter of the prior
year. Total operating expenses for the fourth quarter of 2007
increased to $3.5 million, compared with $2.9 million for the same
period last year.
Cash and Cash Equivalents
Cash and cash equivalents at December 31, 2007 were $17.0 million
compared to $4.9 million at December 31, 2006.
Recent Clinical Development Highlights
In March 2008, Response Genetics, Inc. also expanded its test
offerings to include ResponseDX: Lung(TM) (ERCC1, RRM1, KRAS, EGFR)
and ResponseDX: Colon(TM) (ERCC1, KRAS, TS) to select medical
institutions and practice groups through its CLIA-registered
laboratory. Response Genetics, Inc. owns multiple patents for the
proprietary PCR-based analysis of ERCC1 and TS as biomarkers for
platinum-based chemotherapy.
The complete genetic tests offered for patients with NSCLC or CRC
comprise:
ERCC1 Gene Expression
Available in ResponseDX: Lung(TM) and ResponseDX: Colon(TM): This
test measures ERCC1 gene expression, a molecular marker to identify
NSCLC and CRC patients who may or may not benefit from platinum-based
therapy.
KRAS Mutation Analysis
Available in ResponseDX: Lung(TM) and ResponseDX: Colon(TM): This
test determines whether or not the K-ras gene (KRAS) contains
mutations. A mutated KRAS is a very strong predictor of non-response
and no benefit from the epidermal growth factor receptor (EGFR)
inhibitors erlotinib and gefitinib.
EGFR Amplification
Available in ResponseDX: Lung(TM): This test measures the number
of copies (gene amplification) of EGFR. A high number of gene copies
has been shown to correlate with increased response of NSCLC to the
EGFR inhibitors erlotinib and gefitinib.
RRM1 Gene Expression
Available in ResponseDX: Lung(TM): This test measures RRM1 gene
expression, a molecular marker to identify NSCLC patients who may or
may not benefit from chemotherapy regimens that include gemcitabine.
TS Gene Expression
Available in ResponseDX: Colon(TM): This test determines the level
of gene expression of thymidylate synthase (TS) in tumor tissue. TS
expression is a predictor of response to fluoropyrimidine-based
chemotherapy.
ResponseDX: Lung(TM) and ResponseDX: Colon(TM) are PCR-based tests
that help guide therapeutic treatment decisions in patients with
non-small cell lung cancer (NSCLC) and colorectal cancer (CRC). All of
these tests can be performed on one formalin-fixed paraffin-embedded
(FFPE) tumor tissue sample, which eliminates the need for additional
tumor samples. The tests are currently in their initial launch phase
and are available only to pre-qualified institutions at this time.
During this initial launch, Response Genetics, Inc. is gathering
additional data about the utility of these genetic tests, including
ERCC1 gene expression, in the treatment of NSCLC and CRC; clinical
practice activities such as sample acquisition, logistics, patient and
physician communication; and the use of the test in normal clinical
practice related to NSCLC and CRC.
Although the focus of Response Genetics, Inc. is currently
ResponseDX: Lung(TM) and ResponseDX: Colon(TM) the Company continues
to move the rest of the diagnostic pipeline along for additional tumor
types. Since platinum-based therapies are standard of care for about
500,000 newly diagnosed cancer patients per year in the United States,
Response Genetics, Inc. is validating the use of single gene tests in
other tumor types such as gastric, ovarian, and esophageal cancers.
To access the teleconference, please follow these instructions.
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Teleconference Information:
Toll Free: 1-877-407-8033
International: 1-201-689-8033
Conference ID: 279501
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A webcast of this event is available at
http://www.investorcalendar.com/IC/CEPage.asp?ID=127528
A replay of this teleconference is available until 4/5/2008. To
access the replay, follow these instructions:
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Toll Free: 1-877-660-6853
International: 1-201-612-7415
Passcodes: Account #: 286 and Conference ID #: 279501
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About Response Genetics, Inc.
Response Genetics, Inc. (RGI) (the "Company") is engaged in the
research and development of pharmacogenomic cancer diagnostic tests
based on its proprietary and patented technologies. RGI´s technologies
enable extraction and analysis of genetic information from genes
derived from tumor samples stored as formalin-fixed and paraffin
embedded specimens. RGI currently generates revenue primarily from the
sales of its proprietary analytical pharmacogenomic testing services
of clinical trial specimens to the pharmaceutical industry. The
Company was founded in 1999 and its principal headquarters are located
in Los Angeles, California. For more information, please visit
www.responsegenetics.com.
Forward Looking Statement Notice
Except for the historical information contained herein, this press
release and the statements of representatives of Response Genetics,
Inc. (the "Company") related thereto contain or may contain, among
other things, certain forward-looking statements, within the meaning
of the Private Securities Litigation Reform Act of 1995. Such
forward-looking statements involve significant risks and
uncertainties. Such statements may include, without limitation,
statements with respect to the Company´s plans, objectives,
projections, expectations and intentions, such as the ability of the
Company to analyze cancer samples, the potential for using the results
of this research to develop diagnostic tests for cancer, the
usefulness of genetic information to tailor treatment to patients, the
ability of the Company to make its ResponseDX: Lung and ResponseDX:
Colon tests, including its ERCC-1 molecular diagnostic test available
in the first quarter of 2008, or at all, and other statements
identified by words such as "projects," "may," "could," "would,"
"should," "believes," "expects," "anticipates," "estimates,"
"intends," "plans" or similar expressions.
These statements are based upon the current beliefs and
expectations of the Company´s management and are subject to
significant risks and uncertainties, including those detailed in the
Company´s filings with the Securities and Exchange Commission. Actual
results, including, without limitation, actual sales results, if any,
or the application of funds, may differ from those set forth in the
forward-looking statements. These forward-looking statements involve
certain risks and uncertainties that are subject to change based on
various factors (many of which are beyond the Company´s control). The
Company undertakes no obligation to publicly update forward-looking
statements, whether because of new information, future events or
otherwise, except as required by law.
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RESPONSE GENETICS, INC.
CONSOLIDATED BALANCE SHEETS
As of December 31,
---------------------------
2006 2007
------------- -------------
ASSETS
Current assets
Cash and cash equivalents $ 4,930,123 $ 17,024,209
Accounts receivable 1,288,255 4,206,765
Prepaid expenses and other current assets 837,238 562,403
----------------------------------------------------------------------
Total current assets 7,055,616 21,793,377
Property and equipment, net 1,184,963 2,593,303
Other assets 19,102 27,353
----------------------------------------------------------------------
Total assets $ 8,259,681 $ 24,414,033
======================================================================
LIABILITIES AND STOCKHOLDERS´ EQUITY
(DEFICIT)
Current liabilities
Accounts payable $ 404,008 $ 234,705
Accrued expenses 547,119 305,517
Accrued royalties 123,852 264,551
Accrued payroll, bonus and related
liabilities 595,276 521,123
Deferred revenue 1,628,325 7,191,514
----------------------------------------------------------------------
Total current liabilities 3,298,580 8,517,410
Notes payable to stockholders 716,854 --
Accrued interest on notes payable to
stockholders 329,036 --
Accrued dividends 6,097,579 --
Deferred revenue, net of current portion 3,320,000 790,848
----------------------------------------------------------------------
Total liabilities 13,762,049 9,308,258
----------------------------------------------------------------------
Commitments and contingencies
Stockholders´ (deficit) equity
Series B Convertible Preferred Stock,
$0.01 par value; 1,038,048 and 0 issued
and outstanding (liquidation preference
of $9 per share, or $9,342,432 plus
accrued but unpaid dividends) at
December 31, 2006 and December 31, 2007,
respectively 10,380 --
Series A Junior Convertible Preferred
Stock, $0.01 par value; 500,000 and 0
issued and outstanding (liquidation
preference of $5 per share, or
$2,500,000) at December 31, 2006 and
December 31, 2007, respectively 5,000 --
Common stock, $0.01 par value; 20,000,000
and 50,000,000 shares authorized;
2,726,320 and 10,239,276 shares issued
and
outstanding at December 31, 2006 and
December 31, 2007,
respectively 27,263 102,393
Additional paid-in capital 9,722,273 35,356,569
Accumulated deficit (15,267,284) (20,320,191)
Accumulated other comprehensive loss -- (32,996)
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Total stockholders´ (deficit) equity (5,502,368) 15,105,775
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Total liabilities and stockholders´
(deficit) equity $ 8,259,681 $ 24,414,033
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RESPONSE GENETICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Years Ended
Ended December 31, December 31,
--------------------------- -------------------------
2006 2007 2006 2007
------------- ------------- ------------ ------------
(Unaudited) (Unaudited)
----------------------------------------------------------------------
Revenue $ 2,199,100 $ 2,434,758 $ 6,017,025 $ 7,789,789
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Operating
expenses:
Cost of revenue 834,169 1,129,473 2,456,071 4,045,715
General and
administrative 1,699,218 1,821,392 3,933,660 6,786,890
Research and
development 399,184 566,293 1,261,981 2,455,044
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Total operating
expenses 2,932,571 3,517,158 7,651,712 13,287,649
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Operating loss (733,471) (1,082,400) (1,634,687) (5,497,860)
Other income
(expense):
Interest expense (13,590) (1,815) (57,537) (28,669)
Interest income 26,284 192,381 138,598 517,645
Other 17,783 -- 196,783 --
----------------------------------------------------------------------
Loss before
income taxes (702,994) (891,834) (1,356,843) (5,008,884)
Provision for
income taxes -- 19,722 800 44,023
----------------------------------------------------------------------
Net loss (702,994) (911,556) (1,357,643) (5,052,907)
Preferred stock
dividends (233,560) -- (934,244) (412,625)
-----------------============--============--===========--===========-
Net loss
attributable to
common
stockholders $ (936,554) $ (911,556) $(2,291,887) $(5,465,532)
======================================================================
Net loss per
share -- basic $ (0.34) $ (0.09) $ (0.84) $ (0.78)
============================== =======================================
Net loss per
share --
diluted $ (0.34) $ (0.09) $ (0.84) $ (0.78)
============================== =======================================
Weighted-average
shares -- basic 2,726,320 10,239,276 2,726,320 6,987,092
======================================================================
Weighted-average
shares --
diluted 2,726,320 10,239,276 2,726,320 6,987,092
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