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LA JOLLA PHARMACEUTICAL COMPANY
REPORTS FIRST QUARTER 2004 FINANCIAL RESULTS
SAN DIEGO, May 6, 2004 -- La Jolla Pharmaceutical Company (Nasdaq:
LJPC) reported a net loss for the first quarter ended March 31,
2004 of $8.4 million, or $0.15 per share (on 54.7 million weighted
average shares), compared to a net loss of $13.5 million, or $0.32
per share (on 42.5 million weighted average shares), for the first
quarter of 2003.
Research and development expenses decreased to $6.8 million for
the three months ended March 31, 2004 from $11.9 million for the
same period in 2003 primarily due to a decrease in expenses related
to the Companys open-label follow-on clinical trial of Riquent®
which was closed in April 2003, a decrease in expenses related
to the unblinding and analysis of the data from the Companys
Phase 3 trial of Riquent in the first quarter of 2003 and a decrease
in personnel costs related to the organizational restructuring
that occurred in May 2003.
Cash, cash equivalents and short-term investments as of March
31, 2004 were $53.7 million compared to $32.1 million as of December
31, 2003. In February and March 2004, the Company sold an aggregate
of 10.0 million shares of its common stock in a public offering
for net proceeds, after expenses, of approximately $29.4 million.
The Company anticipates that its existing cash, cash investments
and interest earned thereon will be sufficient to fund the Companys
operations as currently planned into the second quarter of 2005,
assuming that the Company does not engage in any significant clinical
trial or commercialization activities and further assuming that
the Company does not enter into an agreement with a collaborative
partner or engage in any other fundraising activities.
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 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 website at 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. Although our New Drug Application ("NDA")
for Riquent® has been accepted by the United States Food and
Drug Administration (the "FDA") for review, there is
no guarantee that the FDA will approve Riquent in a timely manner,
or at all. Our 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"),
are ongoing and 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 to the secondary endpoint, time
to treatment with high-dose corticosteroids or cyclophosphamide.
Although our NDA for Riquent has been accepted for review by the
FDA, the results from our clinical trials of Riquent 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 is no guarantee, however, that we will have the necessary
resources to complete any additional trial, that we will elect
to conduct an 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 additional clinical
trials, 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: obtaining required
regulatory approvals, including delays associated with any approvals
that we may obtain; the clear need for additional financing; our
ability to pass FDA pre-approval inspections of our manufacturing
facilities and processes; 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.
Fourth
Quarter 2003 Financial Report in PDF format
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