28.02.2008 12:30:00
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La Jolla Pharmaceutical Company Reports Fourth Quarter and Year-End Financial Results
La Jolla Pharmaceutical Company (Nasdaq:LJPC) reported a net loss for
the three months ended December 31, 2007 of $14.4 million, or $0.36 per
share (on 39.6 million weighted-average shares), compared to a net loss
of $10.7 million, or $0.33 per share (on 32.7 million weighted-average
shares), for the same period in 2006. The Company reported a net loss
for the twelve months ended December 31, 2007 of $53.1 million, or $1.40
per share (on 37.8 million weighted-average shares), compared to a net
loss of $39.4 million, or $1.21 per share (on 32.6 million
weighted-average shares), for the same period in 2006.
Research and development expenses increased to $12.6 million and $46.6
million, respectively, for the three and twelve months ended December
31, 2007 from $9.2 million and $32.9 million, respectively, for the same
periods in 2006. These increases were primarily attributable to
increased activity in the Phase 3 clinical trial of Riquent®.
General and administrative expenses increased to $2.4 million for the
three months ended December 31, 2007 from $2.1 million for the same
period in 2006 and decreased to $9.1 million for the twelve months ended
December 31, 2007 from $9.3 million for the same period in 2006. The
increase for the three months ended December 31, 2007 was primarily due
to an increase in consulting expenses for business development and
market research. The decrease for the twelve months ended December 31,
2007 was primarily due to a decrease in termination benefits, which for
the prior period were mainly severance and additional expense for
accelerated stock option vesting related to the former Chairman and
Chief Executive Officer’s departure in the
first quarter of 2006. This decrease was partially offset by the
write-off of selected patent applications for technologies not related
to Riquent® or the
Company’s small molecule SSAO inhibitors, as
well as an increase in share-based compensation expense.
Cash, cash equivalents and short-term investments as of December 31,
2007 were $39.4 million compared to $42.9 million as of December 31,
2006. In April 2007, the Company received net proceeds of approximately
$37.9 million from the sale of a total of 6.7 million shares of its
common stock.
About Riquent
Riquent is being developed to specifically treat lupus renal disease by
preventing or delaying renal flares, a leading cause of sickness and
death in lupus patients. It is also being studied to assess whether
Riquent treatment improves proteinuria, as was observed in previous
clinical trials. Proteinuria is an indicator of abnormal renal function.
Riquent has been well tolerated in all 14 clinical trials, with no
overall difference in the adverse event profiles for Riquent-treated
patients compared with placebo-treated patients. Riquent specifically
reduces circulating levels of anti-dsDNA antibodies. Increases in these
antibodies are associated with an increased risk of renal flare.
Although clinical benefit has not yet been proven, Riquent treatment has
significantly reduced these antibody levels in all clinical trials in
which they were measured.
About La Jolla Pharmaceutical Company
La Jolla Pharmaceutical Company is dedicated to improving and preserving
human life by developing innovative pharmaceutical products. The Company’s
leading product in development is Riquent®,
which is designed to treat lupus renal disease by preventing or delaying
renal flares. Lupus renal disease is a leading cause of sickness and
death in patients with lupus. The Company has also developed potential
small molecule drug candidates to treat various other autoimmune and
inflammatory conditions. The Company's common stock is traded on The
Nasdaq Global Market under the symbol LJPC. More information about the
Company is available on its Web site: http://www.ljpc.com.
The forward-looking statements in this press release involve
significant risks, assumptions and uncertainties, and a number of
factors, both foreseen and unforeseen, could cause actual results to
differ materially from our current expectations. Forward-looking
statements include those that express a plan, belief, expectation,
estimation, anticipation, intent, contingency, future development or
similar expression. The analyses of clinical results of Riquent®
(abetimus sodium), previously known as LJP 394, our drug candidate for
the treatment of systemic lupus erythematosus (lupus), and any other
drug candidate that we may develop, including the results of any trials
or models that are ongoing or that we may initiate in the future, could
result in a finding that these drug candidates are not effective in
large patient populations, do not provide a meaningful clinical benefit,
or may reveal a potential safety issue requiring us to develop new
candidates. The analysis of the data from our previous Phase 3
trial of Riquent showed that the trial did not reach statistical
significance with respect to its primary endpoint, time to renal flare,
or with respect to its secondary endpoint, time to treatment with
high-dose corticosteroids or cyclophosphamide. The results from
our clinical trials of Riquent, including the results of any trials that
are ongoing or that we may initiate in the future, may not ultimately be
sufficient to obtain regulatory clearance to market Riquent either in
the United States or any other country, and we may be required to
conduct additional clinical studies to demonstrate the safety and
efficacy of Riquent in order to obtain marketing approval. There
can be no assurance, however, that we will have the necessary resources
to complete any current or future trials or that any such trials will
sufficiently demonstrate the safety and efficacy of Riquent. Our
ability to develop and sell our products in the future may be adversely
affected by the intellectual property rights of third parties or the
validity or enforceability of our intellectual property rights. Additional
risk factors include the uncertainty and timing of: the availability of
sufficient financial resources; obtaining required regulatory approvals,
including delays associated with any approvals that we may obtain; the
timely supply of drug product for clinical trials; our ability to pass
all necessary regulatory inspections; the increase in capacity of our
manufacturing capabilities for possible commercialization; successfully
marketing and selling our products; our lack of manufacturing, marketing
and sales experience; our ability to make use of the orphan drug
designation for Riquent; generating future revenue from product sales or
other sources such as collaborative relationships; future profitability;
and our dependence on patents and other proprietary rights. Accordingly,
you should not rely upon forward-looking statements as predictions of
future events. The outcome of the events described in these
forward-looking statements are subject to the risks, uncertainties and
other factors described in the "Risk Factors”
contained in our Annual Report on Form 10-K for the year ended December
31, 2006, and in other reports and registration statements that we file
with the Securities and Exchange Commission from time to time. We
expressly disclaim any intent to update forward-looking statements. La Jolla Pharmaceutical Company Condensed Consolidated Financial Statements (in thousands
except per share amounts)
Summary of Operations Three Months Ended December 31, (Unaudited) Twelve Months Ended December 31,
2007
2006
2007
2006
Research and development expenses
$
12,626
$ 9,174
$
46,635
$
32,938
General and administrative expenses
2,381
2,116
9,058
9,287
Total expenses
15,007
11,290
55,693
42,225
Loss from operations
(15,007
)
(11,290
)
(55,693
)
(42,225
)
Interest income
615
615
2,699
2,826
Interest expense
(8
)
(19
)
(82
)
(46
)
Net loss
$
(14,400
)
$(10,694
)
$
(53,076
)
$
(39,445
)
Basic and diluted net loss per share
$
(0.36
)
$ (0.33
)
$
(1.40
)
$
(1.21
)
Shares used in computing basic and diluted net loss per share
39,607
32,660
37,818
32,588
Balance Sheet Information
December 31, 2007
December 31, 2006
Assets
Cash, cash equivalents, and short-term investments
$
39,359
$
42,909
Other assets
5,046
6,616
Total assets
$
44,405
$
49,525
Liabilities and Stockholders’ Equity
Liabilities
$
10,884
$
6,436
Stockholders’ equity
33,521
43,089
Total liabilities and stockholders’ equity
$
44,405
$
49,525
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