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LA JOLLA PHARMACEUTICAL COMPANY
REPORTS SECOND QUARTER 2004 FINANCIAL RESULTS
SAN DIEGO, August 5, 2004 -- La Jolla Pharmaceutical Company (Nasdaq:
LJPC) reported a net loss for the second quarter ended June 30,
2004 of $8.4 million, or $0.14 per share (on 61.2 million weighted
average shares), compared to a net loss of $9.9 million, or $0.23
per share (on 42.6 million weighted average shares), for the second
quarter of 2003. The net loss for the six months ended June 30,
2004 was $16.7 million, or $0.29 per share (on 58.0 million weighted
average shares), compared to a net loss of $23.5 million, or $0.55
per share (on 42.6 million weighted average shares), for the same
period in 2003.
Research and development expenses decreased to $6.8 million for
the three months ended June 30, 2004 from $8.4 million for the
same period in 2003 primarily due to decreases in costs incurred
for clinical studies of Riquent® including the Companys
open-label follow-on clinical trial which was closed in April
2003.
Research and development expenses decreased to $13.6 million for
the six months ended June 30, 2004 from $20.3 million for the
same period in 2003 primarily due to the decrease in expenses
noted above and a decrease in expenses related to the unblinding
and analysis of data from the Phase 3 trial of Riquent in the
first quarter of 2003.
Cash, cash equivalents and short-term investments as of June 30,
2004 were $44.2 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. Even though our New Drug Application ("NDA")
for Riquent® has been accepted by the United States Food and
Drug Administration (the "FDA") for review, and even
though we have agreed with the FDA regarding the design of a potential
Phase 4 trial and we have initiated the trial, there is no guarantee
that the FDA will approve Riquent in a timely manner, or at all.
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"),
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. 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 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 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.
2nd Quarter Financial Results
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