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LA JOLLA PHARMACEUTICAL COMPANY
REPORTS THIRD QUARTER 2004 FINANCIAL RESULTS
SAN DIEGO, November 4, 2004 -- La Jolla Pharmaceutical Company
(Nasdaq: LJPC) reported a net loss for the third quarter ended
September 30, 2004 of $12.8 million, or $0.21 per share (on 61.3
million weighted average shares), compared to a net loss of $6.9
million, or $0.15 per share (on 47.1 million weighted average
shares), for the third quarter of 2003. The net loss for the nine
months ended September 30, 2004 was $29.6 million, or $0.50 per
share (on 59.1 million weighted average shares), compared to a
net loss of $30.4 million, or $0.69 per share (on 44.1 million
weighted average shares), for the same period in 2003.
Research and development expenses increased to $10.7 million for
the three months ended September 30, 2004 from $5.6 million for
the same period in 2003 primarily due to the purchase of a large
amount of raw materials, which the Company expects to use in the
production of validation lots of Riquent® in 2004. The Company
expects to use the validation lots in connection with the submission
of the Marketing Authorization Application in Europe, and for
other purposes, including the Companys ongoing clinical
trial.
Research and development expenses decreased to $24.3 million for
the nine months ended September 30, 2004 from $26.0 million for
the same period in 2003 primarily due to decreases in costs incurred
for clinical studies of Riquent, including the open-label follow-on
clinical trial which was closed in April 2003 and the unblinding
and analysis of the data from the Phase 3 trial of Riquent in
the first quarter of 2003. These decreases were partially offset
by the increase in expenses noted above during the third quarter.
Cash, cash equivalents and short-term investments as of September
30, 2004 were $35.2 million compared to $32.1 million as of December
31, 2003.
La Jolla Pharmaceutical Company is a biotechnology company developing
therapeutics for antibody-mediated autoimmune diseases and inflammation
afflicting several million people in the United States and Europe.
The Company is developing Riquent for the treatment of lupus kidney
disease, a leading cause of sickness and death in patients with
lupus. The Company is also developing LJP 1082 for the treatment
of antibody-mediated thrombosis, a condition in which patients
suffer from recurrent stroke, deep-vein thrombosis, miscarriage
and other thrombotic events, and is in the early stage of developing
small molecules to treat various other autoimmune and inflammatory
conditions. The Company's common stock is traded on The Nasdaq
Stock Market under the symbol LJPC. For more information about
the Company, visit its Web site: http://www.ljpc.com.
The forward-looking statements in this press release involve
significant risks 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, previously
known as LJP 394, our drug candidate for the treatment of systemic
lupus erythematosus ("lupus"), and LJP 1082, our drug
candidate for the treatment of antibody-mediated thrombosis ("thrombosis"),
including the results of any trials 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 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 the 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 Europe, 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 additional trial or that any additional trial will sufficiently
demonstrate the safety and efficacy of Riquent. Our blood test
to measure the binding affinity for Riquent is experimental, has
not been validated by independent laboratories and will likely
be reviewed as part of the Riquent approval process. Our other
potential drug candidates are at earlier stages of development
and involve comparable risks. Analysis of our clinical trials
could have negative or inconclusive results. Any positive results
observed to date may not be indicative of future results. In any
event, regulatory authorities may require clinical trials in addition
to our current clinical trial, or may not approve our drugs. Our
ability to develop and sell our products in the future may be
adversely affected by the intellectual property rights of third
parties. Additional risk factors include the uncertainty and timing
of: our clear need for additional financing; obtaining required
regulatory approvals, including delays associated with any approvals
that we may obtain; our ability to pass all necessary FDA 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. Readers
are cautioned to not place undue reliance upon forward-looking
statements, which speak only as of the date hereof, and we undertake
no obligation to update forward-looking statements to reflect
events or circumstances occurring after the date hereof. Interested
parties are urged to review the risks described in our Annual
Report on Form 10-K for the year ended December 31, 2003, and
in other reports and registration statements that we file with
the Securities and Exchange Commission from time to time.
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