La Jolla Pharmaceutical Company (Nasdaq: LJPC) reported a net loss for
the three months ended March 31, 2008 of $13.6 million, or $0.34 per
share (on 39.6 million weighted-average shares), compared to a net loss
of $11.9 million, or $0.36 per share (on 32.7 million weighted-average
shares), for the same period in 2007.
Research and development expense increased to $11.3 million for the
three months ended March 31, 2008 from $10.4 million for the same period
in 2007. This increase was primarily attributable to increased activity
in the Phase 3 clinical trial of Riquent®.
General and administrative expense of $1.9 million for the three months
ended March 31, 2008 was comparable to $2.0 million for the three months
ended March 31, 2007.
Cash, cash equivalents and short-term investments as of March 31, 2008
were $25.4 million compared to $39.4 million as of December 31, 2007.
Short-term investments consist of AAA rated student loan auction rate
securities net of realized impairment losses of $0.8 million recorded in
the first quarter of 2008.
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 and is also designed
to specifically suppress the B cells that make these antibodies.
Decreases in these antibodies are believed to be associated with a
decreased 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: our ability to raise
additional capital; 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, 2007, 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 March 31, (Unaudited) 2008
2007
Research and development expenses
$
11,338
$
10,375
General and administrative expenses
1,906
1,980
Total expenses
13,244
12,355
Loss from operations
(13,244
)
(12,355
)
Interest income, net
344
485
Net realized loss on investments
(737
)
--
Net loss
$
(13,637
)
$
(11,870
)
Basic and diluted net loss per share
$
(0.34
)
$
(0.36
)
Shares used in computing basic and diluted net loss per share
39,631
32,737
Balance Sheet Information March 31, 2008 December 31, 2007 (Unaudited) Assets
Cash, cash equivalents, and short-term investments
$
25,362
$
39,359
Other assets
4,822
5,046
Total assets
$
30,184
$
44,405
Liabilities and Stockholders’ Equity
Liabilities
$
9,126
$
10,884
Stockholders’ equity
21,058
33,521
Total liabilities and stockholders’ equity
$
30,184
$
44,405
