La Jolla Pharmaceutical Company
The
information in this preliminary prospectus supplement and the
accompanying prospectuses is not complete and may be changed.
Registration statements relating to these securities have been
declared effective by the Securities and Exchange Commission.
This preliminary prospectus supplement and the accompanying
prospectuses are not an offer to sell these securities and we
are not soliciting an offer to buy these securities in any state
where the offer or sale is not permitted.
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Filed pursuant to Rule
424(b)(5)
File Nos. 333-101499
333-145009
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PRELIMINARY
PROSPECTUS SUPPLEMENT
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SUBJECT TO COMPLETION
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May 6, 2008
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(To
Prospectuses dated December 12, 2002 and August 23,
2007)
Units
Consisting
of Common Stock and Warrants
We are
offering units,
with each unit consisting of one share of common stock and a
warrant to
buy shares
of common stock. Each warrant has an exercise price of
$
per share, has a term of five years and is exercisable beginning
on the date of issue. The shares of common stock and warrants
comprising the units are immediately separable and will be
issued separately.
Our common stock is listed on the NASDAQ Global Market under the
symbol LJPC. The last reported sale price of our
common stock on May 5, 2008 was $1.95 per share. We do not
intend to list the warrants for trading on any recognized
securities exchange.
We have received indications from certain of our principal
stockholders of their intent to offer to purchase, either
directly or through one or more of their affiliated investment
funds, approximately
$ million,
or %,
of the units offered hereby.
Investing in our
securities involves a high degree of risk. Before buying any
securities, you should read the discussion of material risks of
investing in our securities in Risk factors
beginning on
page S-5
of this prospectus supplement.
Neither the
Securities and Exchange Commission nor any state securities
commission has approved or disapproved these securities or
determined if this prospectus supplement or the accompanying
prospectuses are truthful or complete. Any representation to the
contrary is a criminal offense.
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Per
unit
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Total
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Public offering price
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$
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$
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Underwriting discounts and commissions
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$
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$
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Proceeds, before expenses, to us
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$
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$
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The above summary of offering proceeds to us does not give
effect to any exercise of the warrants being issued in this
offering.
The underwriters may also purchase up to an
additional units
from us at the public offering price, less underwriting
discounts and commissions payable by us to cover
over-allotments, if any, within 30 days from the date of
this prospectus supplement. If the underwriters exercise the
option in full, the total underwriting discounts and commissions
will be $ , and the total proceeds,
before expenses, to us will be $ .
The underwriters are offering the securities as set forth under
Underwriting. Delivery of the units will be made on
or
about ,
2008.
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UBS
Investment Bank |
Canaccord Adams |
You should rely only on the information contained or
incorporated by reference in this prospectus supplement and the
accompanying prospectuses. We have not authorized anyone to
provide you with different information. We are offering to sell,
and seeking offers to buy, shares of our common stock and
warrants only in jurisdictions where offers and sales are
permitted. The information contained in this prospectus
supplement and the accompanying prospectuses, as well as the
information that we have previously filed with the Securities
and Exchange Commission and incorporated by reference, is
accurate only as of the date of the applicable document,
regardless of the time of delivery of this prospectus supplement
or of any sale of our common stock or warrants. The descriptions
set forth in this prospectus supplement replace and supplement,
where inconsistent, the description of the general terms and
provisions set forth in the accompanying prospectuses.
TABLE OF
CONTENTS
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PROSPECTUS SUPPLEMENT
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DECEMBER 12, 2002 PROSPECTUS
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AUGUST 23, 2007 PROSPECTUS
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i
About this
prospectus supplement
This prospectus supplement contains the terms of this offering.
A description of our capital stock is contained in this
prospectus supplement. This prospectus supplement, with the
documents incorporated by reference in this prospectus
supplement and the accompanying prospectuses, may add, update or
change information in the accompanying prospectuses. If
information in this prospectus supplement, or the documents
incorporated by reference in this prospectus supplement and the
accompanying prospectuses, is inconsistent with the accompanying
prospectuses, this prospectus supplement, or the documents
incorporated by reference in this prospectus supplement and the
accompanying prospectuses, will apply and will supersede the
information in the accompanying prospectuses.
On December 21, 2005, we completed a one-for-five reverse
stock split. The reverse stock split caused every five shares of
our outstanding common stock to convert automatically into one
share of common stock. All share and share related information
set forth in this prospectus supplement and the August 23,
2007 accompanying prospectus is presented on a post-reverse
stock split basis. Because we completed this reverse stock split
subsequent to the date of the December 12, 2002
accompanying prospectus, all share and share related information
set forth in the December 12, 2002 accompanying prospectus
remains presented on a pre-reverse stock split basis.
Please read and consider all information contained in this
prospectus supplement, the accompanying prospectuses and the
documents incorporated by reference in this prospectus
supplement and the accompanying prospectuses, including our
Annual Report on
Form 10-K
for the year ended December 31, 2007 filed with the
Securities and Exchange Commission on March 17, 2008,
together with the additional information described under the
section entitled Where you can find more information and
incorporation by reference in this prospectus supplement
and the section entitled Risk factors in this
prospectus supplement before you make an investment decision.
This prospectus supplement and the accompanying prospectuses do
not constitute an offer or solicitation by anyone in any
jurisdiction in which an offer or solicitation is not authorized
or in which the person making an offer or solicitation is not
qualified to do so, or to anyone to whom it is unlawful to make
an offer or solicitation.
ii
Summary
This is only a summary of the offering. It may not contain
all of the information that may be important to you. To fully
understand the investment you are contemplating, you should read
this prospectus supplement, the accompanying prospectuses and
the detailed information incorporated into them by reference
before you decide to make an investment. Unless the context
otherwise requires, the terms we, us and
our refer to La Jolla Pharmaceutical Company, a
Delaware corporation and our wholly owned subsidiary.
THE
COMPANY
We are a biopharmaceutical company dedicated to improving and
preserving human life by developing innovative pharmaceutical
products. Our leading product in development, Riquent, is
designed to treat lupus renal (kidney) disease by preventing or
delaying renal flares. Lupus renal disease is a
life-threatening, antibody-mediated disease in which
disease-causing antibodies damage the kidneys. Renal flares are
periods of extreme, acute kidney inflammation in patients
suffering from lupus renal disease. Riquent is currently in a
Phase 3 clinical trial under a Special Protocol Assessment and
has been granted Fast Track designation by the FDA.
Lupus renal disease is a chronic illness that can lead to
irreversible renal damage, renal failure and the need for
dialysis, and is a leading cause of death in lupus patients.
Lupus is an antibody-mediated disease caused by autoantibodies,
of which antibodies to double-stranded DNA (dsDNA)
are an important subgroup. Riquent is designed to prevent or
delay renal flares by lowering the levels of circulating
antibodies to dsDNA, which are believed to cause lupus renal
disease. Current treatments for this autoimmune disorder often
address only symptoms of the disease, or nonspecifically
suppress the entire immune system, which can result in severe,
negative side effects and hospitalization. We believe that
Riquent has the potential to treat lupus renal disease without
these severe, negative side effects. The Lupus Foundation
estimates that there are approximately one million lupus
patients in the United States. We believe that 40% to 45% of
these lupus patients will develop renal disease.
We have also developed novel, orally-active, small-molecule SSAO
inhibitors for the treatment of autoimmune diseases and acute
and chronic inflammatory disorders. Preclinical studies have
shown that these inhibitors reduce disease activity in animal
models of multiple sclerosis, rheumatoid arthritis, inflammatory
bowel disease, stroke, systemic inflammation and acute
inflammation.
RECENT
DEVELOPMENTS
We recently announced positive
12-month
interim antibody data from our ongoing double-blind,
placebo-controlled, randomized Phase 3 study of Riquent referred
to as the Phase 3 ASPEN study (Abetimus Sodium
in Patients with a History of Lupus Nephritis). Analyses of
12-month
interim antibody data in the first 125 patients randomized
in the study indicate that for all patients treated with
900 mg, 300 mg or 100 mg of Riquent per week
compared with placebo, there were significantly greater
reductions in antibodies to dsDNA (p < 0.0001).
The data show a dose-response curve for antibody reduction and
also show that the 300 mg and 900 mg doses appear to
be near the top of the antibody-related dose-response curve,
thus supporting the choice of doses for this study. Antibody
levels in the placebo-treated group remained around baseline
levels throughout the 12 months. The rate at which antibody
levels were maximally reduced appeared to be more rapid in the
900 mg dose group than in the 300 mg or the
100 mg dose groups. Each individual dose group was
significantly different from placebo (p < 0.0001). An area
under the curve (AUC) analysis, which reflects the
effect of the drug on antibody levels over time, showed
significantly greater antibody-lowering effects for the
300 mg and 900 mg dose groups compared with the
placebo group (decreases of 26.9% for 100 mg, 35.5% for
300 mg and 37.7% for 900 mg, compared with an increase
of 7.5% for placebo). The AUC analysis provides additional
evidence that the higher doses of Riquent suppressed antibodies
further than the 100 mg dose group. The proportion of
patients achieving a 50% or greater AUC reduction was 0.0% in
the placebo and 100 mg groups, 23% in the 300 mg
group, and 30% in the 900 mg group. The
12-month
antibody analysis assessed the impact of treatment with
S-1
Riquent or placebo on antibodies to dsDNA. Antibody levels were
measured every two weeks for the first 16 weeks of the
study and then monthly for the remaining 36 weeks. All
demographics and baseline characteristics were comparable across
dosing groups.
We also recently announced that our Phase 3 ASPEN study of
Riquent appears to be progressing well, in that more than 140
clinical trial sites are active and more than 670 patients
have been enrolled. Compliance with weekly visits has been high
and the drop-out rate remains low. The Independent Data
Monitoring Board (DMB) has completed three reviews
of the safety data and has not indicated any safety issues. The
study is an event-driven trial designed to be completed when 128
renal flares have occurred. The current overall renal flare rate
is lower than the original trial assumption. As a result, in an
effort to shorten the time to achieve the required number of
renal flares, we will continue enrollment beyond the initially
targeted 740 patients and extend the treatment period
beyond 12 months until the required number of renal flares
is achieved. We now estimate that at least 800 patients
will be enrolled in the study. Based on these changes, we expect
the trial to complete in the second half of 2009.
The Phase 3 ASPEN study includes two interim efficacy analyses,
each with target p values of p < 0.001 and a final p value
of p < 0.05 at the end of the study. We have added a
futility analysis to each interim efficacy analysis. The interim
efficacy analyses have been moved to occur later in the study
when a greater number of renal flares will have been observed.
As a result, the first interim efficacy analysis is expected to
occur around the fourth quarter of 2008, and the second interim
efficacy analysis is expected to occur about midway between the
first analysis and the expected end of the study.
These modifications to the trial have been discussed with the
FDA, and the trial continues to be conducted under the
FDAs Special Protocol Assessment.
On May 1, 2008, we announced preliminary financial results
for the three months ended March 31, 2008. We reported that
for this period we had a net loss of $13.6 million, or
$0.34 per share, and that at March 31, 2008, we
had cash, cash equivalents and
short-term
investments of $25.4 million. Until completion of a review
and issuance of financial statements for the three months
ended March 31, 2008, any amounts related to this period
are subject to change.
AMENDMENT TO
RIGHTS PLAN
We have received indications from certain of our principal
stockholders Essex Woodlands Health Ventures
Fund VI, L.P., Frazier Healthcare V, L.P. and
Alejandro Gonzalez of their intent to offer to
purchase, either directly or through one or more of their
affiliated investment funds, approximately
$ million,
or %, of the units in this
offering. If these stockholders offer to purchase these units,
we expect that the underwriters will confirm orders to them in
such an amount, and that immediately after the completion of
this offering, Essex Woodlands Health Ventures Fund VI,
L.P. (and its affiliates), Frazier Healthcare V, L.P. (and
its affiliates) and Alejandro Gonzalez (and his affiliates) will
beneficially own
approximately %, %
and %, respectively, of our
outstanding common stock, including the shares issuable to these
stockholders under the warrants to be sold in this offering.
Under the terms of our rights agreement with American Stock
Transfer & Trust Co., dated December 3,
1998, as amended, if Essex Woodlands Health Ventures
Fund VI, L.P. (and its affiliates), Frazier
Healthcare V, L.P. (and its affiliates) and Alejandro
Gonzalez (and his affiliates) purchase units in this offering in
the amounts described above, each such stockholder would become
an acquiring person under the rights agreement and
would trigger the rights issued thereunder. In order to avoid
triggering the rights issued under the rights plan in connection
with this offering, we expect to amend the rights agreement upon
the completion of this offering to allow Essex Woodlands Health
Ventures Fund VI, L.P. (and its affiliates), Frazier
Healthcare V, L.P. (and its affiliates) and Alejandro
Gonzalez (and his affiliates) to beneficially own up
to %, %
and %, respectively, of our
outstanding common stock, in each case, without becoming an
acquiring person under the agreement. See
Description of capital stock La Jolla
Pharmaceutical Company Rights Plan.
S-2
CORPORATE
INFORMATION
We were incorporated in the State of Delaware in 1989. Our
principal executive offices are located at 6455 Nancy Ridge
Drive, San Diego, California 92121 and our telephone number
is
(858) 452-6600.
Our website is located at www.ljpc.com. We have not
incorporated by reference into this prospectus supplement the
information on our website, and you should not consider our
website to be a part of this document. For more complete
information please refer to our Annual Report on
Form 10-K
for the year ended December 31, 2007, filed with the
Securities and Exchange Commission on March 17, 2008.
S-3
The offering
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Common stock we are offering |
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shares,
plus shares
of common stock underlying the warrants offered hereby |
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Common stock warrants we are offering |
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Warrants to
purchase shares
of common stock |
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Common stock to be outstanding after this offering |
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shares,
or shares
if the warrants sold in this offering are exercised in full |
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Purchases by principal stockholders |
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We have received indications from certain of our principal
stockholders of their intent to offer to purchase, either
directly or through one or more of their affiliated investment
funds, up to
$ million,
or %,
of the units offered hereby. If these stockholders offer to
purchase these units, we expect that the underwriters will
confirm orders to them in such an amount. |
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Use of proceeds after expenses |
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We estimate that our net proceeds from this offering will be
approximately
$ million
after deducting underwriting discounts and commissions and
estimated offering expenses. We intend to use the net proceeds
from this offering to fund the development of Riquent and other
general corporate purposes, as further described in this
prospectus supplement under the heading Use of
proceeds. |
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Risk factors |
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See the Risk factors section and other information
included in this prospectus supplement, the accompanying
prospectuses and incorporated by reference for a discussion of
factors you should carefully consider before deciding to invest
in our securities. |
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NASDAQ Global Market Symbol |
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LJPC |
The number of shares outstanding after the offering is based on
39,671,491 shares of common stock outstanding as of
March 31, 2008 and excludes:
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shares
of common stock that are a part of
the units that the
underwriters have a right to purchase from us to cover
over-allotments, if any.
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4,399,992 shares of common stock that may be issued on the
exercise of outstanding warrants at an exercise price of $5.00
per share.
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5,443,354 shares of common stock that may be issued on the
exercise of outstanding stock options granted under our various
stock option plans at a weighted average exercise price of $7.80
per share.
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Approximately 351,765 shares of common stock reserved for
future issuance under our equity incentive and employee stock
purchase plans.
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Unless otherwise indicated, this prospectus supplement does not
assume that any of the warrants issued hereunder will be
exercised.
S-4
Risk factors
The shares of our common stock and warrants offered by this
prospectus supplement and the accompanying prospectuses are
speculative and involve a high degree of risk of loss. Before
making an investment, you should carefully read this entire
prospectus supplement, the accompanying prospectuses and the
information incorporated by reference in them and consider the
following risks and speculative factors. Some of these factors
have affected our financial condition and operating results in
the past or are currently affecting us. All of these factors
could affect our future financial condition or operating
results. If any of the following risks actually occurs, our
business could be very significantly harmed. If that happens,
the trading price of our common stock could decline, and you may
lose all or part of your investment.
RISK FACTORS
RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND THE INDUSTRY IN
WHICH WE OPERATE
We do not have
sufficient financial resources to complete the current Phase 3
ASPEN study of Riquent and may not have sufficient resources to
continue to operate unless we are able to raise sufficient
additional capital.
We will need to successfully complete the current Phase 3 ASPEN
study prior to any FDA or any foreign regulatory approvals. The
current Phase 3 ASPEN study is an event-driven trial requiring
us to accrue a specified number of renal flares to complete the
study. We currently target enrolling at least 800 patients
to achieve the required number of renal flares and the trial
could take several years to complete. We expect that the actual
costs of completing the current Phase 3 ASPEN study will exceed
our current cash resources; we expect that the net proceeds from
this offering, together with our other cash resources, excluding
the value of our currently illiquid auction rate securities,
will enable us to continue our operations as currently planned
through December 31, 2008. If we expend all of the funds
that we have raised and do not receive funding from a
collaborative agreement with a corporate partner or obtain other
equity or debt financing, we would not have the financial
resources to complete the current Phase 3 ASPEN study or to
continue the development of Riquent, and we may not be able to
continue to operate.
We may need to
sell stock or assets, enter into collaborative agreements,
significantly reduce our operations, or merge with another
entity to continue operations.
Our business is highly cash-intensive and we will need a
significant amount of additional cash to continue our
operations. There can be no guarantee that additional financing
will be available to us on favorable terms, or at all, whether
through issuance of additional securities, entry into
collaborative arrangements, or otherwise. If adequate funds are
not available, we may halt the current Phase 3 ASPEN study,
significantly reduce the size of our workforce, sell or license
our technologies or obtain funds through other arrangements with
collaborative partners or others that require us to relinquish
rights to our technologies or potential products. We also may
merge with another entity to continue our operations. Any one of
these outcomes could have a negative impact on our ability to
develop products or achieve profitability if our products are
brought to market. If, and to the extent, we obtain additional
funding through sales of securities, any previous investment in
us will be diluted, and dilution can be particularly substantial
when the price of our common stock is low. Moreover, capital
markets have experienced a period of instability recently and
this instability may make it harder for us to raise capital
within the time periods needed or on terms we consider
acceptable, if at all. In the current economic environment, our
need for additional capital and limited capital resources may
force us to accept financing terms that could be significantly
more dilutive than if we were raising capital when the capital
markets were more stable.
S-5
Negative
conditions in the global credit markets may further impair the
liquidity of a portion of our investment portfolio.
As of March 31, 2008, our investment securities consist
primarily of money market funds and AAA rated asset-backed
student loan auction rate securities. As of December 31,
2007, our short-term investments included $28.0 million of
AAA rated asset-backed student loan auction rate securities
issued primarily by state governments. Subsequent to
December 31, 2007, we sold $18.0 million of these
asset-backed auction rate securities at par value.
The recent negative conditions in the global credit markets have
prevented some investors from liquidating their holdings,
including their holdings of student loan auction rate
securities. As of March 31, 2008, there was insufficient
demand at auction for each of our remaining four AAA rated
asset-backed student loan auction rate securities, representing
the entire $10.0 million we currently hold in asset-backed
auction rate securities. As a result of the insufficient demand,
these four securities are currently not liquid and unless a
future auction (which occurs approximately every
28 to 91 days) for these investments is
successful, we could be required to hold them until they are
redeemed by the issuer or to maturity, which ranges between
20-30 years.
Based on our current capital resources and projected needs, we
will not be able to hold these securities until maturity.
In the event we need to access the funds that are in an illiquid
state, we will not be able to do so without a loss of principal,
until a future auction on these investments is successful, the
securities are redeemed by the issuer or they mature. As of
March 31, 2008, management has determined that our student
loan auction rate securities are impaired and accordingly we
have recorded realized impairment losses of $0.8 million on
these investments. The impairment losses on these investments
were determined to be other-than-temporary as we may be required
to liquidate these auction rate securities in the short term in
order to continue our operations. If the credit ratings of the
security issuers deteriorate
and/or if
there is any further decline in market value that is determined
to be other-than-temporary, we would be required to further
adjust the carrying value of these investments through an
impairment charge.
Our independent
registered public accounting firm has issued an unqualified
opinion with an explanatory paragraph, to the effect that there
is substantial doubt about our ability to continue as a going
concern.
Our independent registered public accounting firm has issued an
unqualified opinion with an explanatory paragraph, to the effect
that there is substantial doubt about our ability to continue as
a going concern. This unqualified opinion with an explanatory
paragraph could have a material adverse effect on our business,
financial condition, results of operations and cash flows. See
Liquidity and Capital Resources,
Managements Discussion and Analysis of Financial
Condition and Results of Operations and note 1 to our
consolidated financial statements included in our Annual Report
on
Form 10-K
for the year ended December 31, 2007, which is incorporated
by reference into this prospectus supplement.
We have no committed sources of capital and do not know whether
additional financing will be available when needed on terms that
are acceptable, if at all. Our current lack of resources is
exacerbated by our inability to liquidate holdings of certain
student loan auction rate securities. The addition of this going
concern statement from our independent registered public
accounting firm may discourage some investors from purchasing
our stock or providing alternative capital financing. The
failure to satisfy our capital requirements will adversely
affect our business, financial condition, results of operations
and prospects.
Unless we raise additional funds, including through the sale of
equity securities and through one or more collaborative
arrangements, we will need to halt the Phase 3 ASPEN study and
significantly reduce our workforce and our operating expenses.
If we do not take these actions, we will not have sufficient
funds to continue operations. Even if we take these actions,
they may be insufficient, particularly if our costs are higher
than projected or unforeseen expenses arise. Halting our Phase 3
S-6
ASPEN study or significantly reducing our workforce or operating
expenses will adversely affect our business and prospects.
In order to
complete our current Phase 3 ASPEN study, we will need to accrue
a sufficient number of renal flares by enrolling a sufficient
number of patients who meet the trial criteria. If we are unable
to successfully complete the trial, our business will be
adversely affected and it may be difficult or impossible for us
to continue to operate.
The current Phase 3 ASPEN study is an event-driven trial
requiring us to accrue a specified number of renal flares to
complete the study. We currently target enrolling at least
800 patients to achieve the required number of renal
flares. We may need to enroll more patients in order to reach
the required number of renal flares. We may have difficulty
enrolling patients because, among other matters, there are
specific limitations on the medications that a patient may be
taking upon entry into the trial and intense competition for
available lupus patients. If we are unable to accrue a
sufficient number of renal flares or to timely enroll a
sufficient number of patients, we will not be able to
successfully complete the current Phase 3 ASPEN study. As a
result, it may be difficult or impossible for us to continue to
operate.
Results from our
clinical trials may not be sufficient to obtain regulatory
approvals to market Riquent or our other drug candidates in the
United States or other countries on a timely basis, if at
all.
Our drug candidates are subject to extensive government
regulations related to development, clinical trials,
manufacturing and commercialization. In order to sell any
product that is under development, we must first receive
regulatory approval. To obtain regulatory approval, we must
conduct clinical trials and toxicology studies that demonstrate
that our drug candidates are safe and effective. The process of
obtaining FDA and foreign regulatory approvals is costly, time
consuming, uncertain and subject to unanticipated delays.
The FDA and foreign regulatory authorities have substantial
discretion in the approval process and may not agree that we
have demonstrated that Riquent is safe and effective. If Riquent
is ultimately not found to be safe and effective, we would be
unable to obtain regulatory approval to manufacture, market and
sell Riquent. Although we have received an approvable letter
from the FDA, 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. In
a preliminary assessment of the MAA submitted in March 2006, the
EMEA reviewers indicated that additional clinical data would be
needed prior to potential approval. Based on our review of the
EMEA assessment, we believe that the current Phase 3 ASPEN study
should provide the necessary data; however, since the data would
not be available within the timeframe that the EMEA regulations
allow for review of the Riquent application we submitted, we
withdrew the application. We plan to refile the MAA after the
completion of the current Phase 3 ASPEN study, if it is
successful. We can provide no assurances that the FDA or foreign
regulatory authorities will ultimately approve Riquent or, if
approved, what the indication for Riquent will be.
As designed, our current Phase 3 ASPEN study contains multiple
dosing levels. Even if the Phase 3 ASPEN study is successful,
the FDA or foreign regulatory authorities may require additional
studies to define dosing recommendations before we can obtain
approval to market Riquent.
Because substantially all of our resources are currently being
devoted to Riquent, our inability to obtain any regulatory
approval of Riquent as a result of the current Phase 3 ASPEN
study would have a severe negative effect on our business, and,
in the future, we may not have the financial resources to
continue the development of Riquent or any other potential drug
candidates.
S-7
We are currently
devoting nearly all of our resources to the development and
approval of Riquent. Accordingly, our efforts with respect to
other drug candidates have significantly diminished.
Future development of our small molecules for the treatment of
autoimmune diseases and acute and chronic inflammatory disorders
depends on our ability to obtain third-party financing for this
program through a joint venture, partnership or other
collaborative arrangement. As a result, progress with respect to
drug candidates other than Riquent, if any, will be
significantly delayed and our success and ability to continue to
operate depends on whether we obtain regulatory approval to
market Riquent.
Current and
future clinical trials may be delayed or halted.
Current and future clinical trials of Riquent, trials of drugs
related to Riquent, or clinical trials of other drug candidates
may be delayed or halted. For example, in 2005, for a period of
time we limited patient enrollment in our Phase 3 ASPEN trial in
an effort to reduce costs. In addition, our Phase
2/3
clinical trial of Riquent was terminated before planned patient
enrollment was completed. Current and future trials may be
delayed or halted for various reasons, including:
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we do not have sufficient financial resources;
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supplies of drug product are not sufficient to treat the
patients in the studies;
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patients do not enroll in the studies at the rate we expect;
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the observed renal flare rate is lower than we expect;
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the products are not effective;
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patients experience negative side effects or other safety
concerns are raised during treatment;
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the trials are not conducted in accordance with applicable
clinical practices; or
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there is political unrest at foreign clinical sites; or
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there are natural disasters at any of our clinical sites.
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If any current or future trials are delayed or halted, we may
incur significant additional expenses, and our potential
approval of Riquent may be delayed, which could have a severe
negative effect on our business.
We may be
required to design and conduct additional trials for
Riquent.
We may be required to design and conduct additional studies to
further demonstrate the safety and efficacy of Riquent, either
before or after a potential approval, which may result in
significant expense and delay. The FDA and foreign regulatory
authorities may require new or additional clinical trials
because of inconclusive results from current or earlier clinical
trials (including the previous Phase
2/3
and Phase 3 trials of Riquent), a possible failure to conduct
clinical trials in complete adherence to FDA good clinical
practice standards and similar standards of foreign regulatory
authorities, the identification of new clinical trial endpoints,
or the need for additional data regarding safety or efficacy. It
is possible that the FDA or foreign regulatory authorities may
not ultimately approve Riquent or our other drug candidates for
commercial sale in any jurisdiction, even if we believe future
clinical results are positive.
We may experience
shortages of Riquent for use in our clinical studies.
We may experience shortages of Riquent for use in our clinical
studies. We are implementing a commercial scale manufacturing
process for Riquent, but we have manufactured only a limited
number of lots of Riquent at this commercial scale. In addition,
the drug supply needed for our current Phase 3 ASPEN study may
require us to manufacture significant quantities of Riquent in a
compressed time frame. If we are unable to manufacture Riquent
in accordance with applicable FDA good manufacturing practices
at this commercial scale, or if we incur production delays our
ability to timely complete clinical trials of Riquent will be
negatively affected.
S-8
If we encounter
delays or difficulties in establishing or maintaining
relationships with manufacturing or distribution contractors,
our ability to timely complete necessary clinical trials and
potentially deliver commercial products may be negatively
affected.
We may enter into arrangements with contract manufacturing
companies to expand our own production capacity in order to meet
demand for our products or to attempt to improve manufacturing
efficiency. If we choose to contract for manufacturing services,
the FDA and comparable foreign regulators would have to approve
the contract manufacturers prior to our use, and these
contractors would be required to comply with strictly enforced
manufacturing standards. We may also enter into agreements with
contractors to prepare and distribute our drug candidates for
use by patients in clinical trials or commercially. If we
encounter delays or difficulties in establishing or maintaining
relationships with contractors to produce, package or distribute
our drug candidates, if they are unable to meet our needs, if
they are not approved by the regulatory authorities, or if they
fail to adhere to applicable manufacturing standards, our
ability to timely complete necessary clinical trials and to
introduce our products into the market would be negatively
affected.
Our limited
manufacturing capabilities and experience could result in
shortages of drugs for future sale, and our revenues and profit
margin could be negatively affected.
We have never operated a commercial manufacturing facility and
we will be required to manufacture Riquent pursuant to
applicable FDA good manufacturing practices. Our inexperience
could result in manufacturing delays or interruptions and higher
manufacturing costs. This could negatively affect our ability to
supply the market on a timely and competitive basis. The sales
of our products, if any, and our profit margins may also be
negatively affected. In addition, substantial capital investment
in the expansion and build-out of our manufacturing facilities
and/or the
engagement of third party contract manufacturers will be
required to enable us to manufacture Riquent, if approved, in
sufficient commercial quantities. We have limited manufacturing
experience, and we may be unable to successfully transition to
commercial production.
Our suppliers may
not be able to provide us with sufficient quantities of
materials that we need to manufacture our products.
We rely on outside suppliers to provide us with specialized
chemicals and reagents that we use to manufacture our drugs. In
order to manufacture Riquent and our other drug candidates in
sufficient quantities for our clinical trials and possible
commercialization, our suppliers will be required to provide us
with an adequate supply of chemicals and reagents. Our ability
to obtain these chemicals and reagents is subject to the
following risks:
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our suppliers may not be able to increase their own
manufacturing capabilities in order to provide us with a
sufficient amount of material for our use;
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some of our suppliers may be required to pass FDA inspections or
validations or to obtain other regulatory approvals of their
manufacturing facilities or processes, and they may be delayed
or unable to do so;
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the materials that our suppliers use to manufacture the
chemicals and reagents that they provide us may be costly or in
short supply; and
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there are a limited number of suppliers that are able to provide
us with the chemicals or reagents that we use to manufacture our
drugs.
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If we are unable to obtain sufficient quantities of chemicals or
reagents, our ability to produce products for clinical studies
and, therefore, to introduce products into the market on a
timely and competitive basis, will be impeded. The subsequent
sales of our products, if any, and our profit margins may also
be negatively affected.
S-9
An interruption
in the operation of our sole manufacturing facility could
disrupt our operations.
We have only one drug manufacturing facility. A significant
interruption in the operation of this facility, whether as a
result of a natural disaster or other causes, could
significantly impair our ability to manufacture drugs for our
clinical trials or possible commercialization.
Retaining our
current personnel and recruiting additional personnel will be
critical to our success.
We are highly dependent on the principal members of our clinical
development, manufacturing and management staff, the loss of
whose services may delay the achievement of our research and
development objectives. Retaining our current key personnel to
perform clinical development, manufacturing, regulatory, and
business development activities will be critical to our near
term success. We expect that recruiting additional qualified
personnel to conduct clinical development, manufacturing,
regulatory, and marketing and sales activities will be required
to successfully further develop Riquent and any additional drug
candidates. Because competition for experienced clinical,
manufacturing, regulatory, business development and marketing
and sales personnel among numerous pharmaceutical and
biotechnology companies and research and academic institutions
is intense, we may not be able to attract and retain these
people. If we cannot attract and retain qualified people, our
ability to conduct necessary clinical trials, manufacture drug,
comply with regulatory requirements, enter into collaborative
agreements and develop and sell potential products may be
negatively affected because, for instance, the trials may not be
conducted properly, or the manufacturing or sales of our
products may be delayed. In addition, we rely on consultants and
advisors to assist us in formulating our clinical,
manufacturing, regulatory, business development, and marketing
and sales strategies. All of our consultants and advisors have
outside employment and may have commitments or consulting or
advisory contracts with other entities that may limit their
ability to contribute to our business.
We will need
additional funds to support our operations.
Our operations to date have consumed substantial capital
resources. Before we can obtain FDA or foreign regulatory
approval for Riquent, we will need to successfully complete the
current Phase 3 ASPEN study and possibly additional trials.
Therefore, we expect to expend substantial amounts of capital
resources for additional product development and clinical trials
of Riquent. We may also devote substantial additional capital
resources to establish commercial-scale manufacturing
capabilities and to market and sell potential products. These
expenses may be incurred prior to or after any regulatory
approvals that we may receive. Even with the net proceeds of
approximately
$ million
from this offering, we will need additional funds to finance our
future operations. Our future capital requirements will depend
on many factors, including:
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the scope and results of our clinical trials;
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our ability to manufacture sufficient quantities of drug to
support clinical trials;
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our ability to obtain regulatory approval for Riquent;
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the time and costs involved in applying for regulatory approvals;
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continued scientific progress in our development programs;
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the size and complexity of our development programs;
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the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims;
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competing technological and market developments;
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our ability to establish and maintain collaborative research and
development arrangements;
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our need to establish commercial manufacturing
capabilities; and
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our ability to develop effective marketing and sales programs.
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S-10
We expect to incur substantial losses each year for at least the
next several years as we continue our planned clinical trial,
manufacturing, regulatory, and development activities. If we
receive regulatory approval for Riquent, or any of our other
drug candidates, our manufacturing, marketing and sales
activities are likely to substantially increase our expenses and
our need for additional working capital. In the future, it is
possible that we will not be able to obtain additional funds and
thus not have adequate resources to support continuation of our
business activities.
Our freedom to
operate our business or profit fully from sales of our products
may be limited if we enter into collaborative
agreements.
We may need to collaborate with other pharmaceutical companies
to gain access to their financial, research, drug development,
manufacturing, or marketing and sales resources. However, we may
not be able to negotiate arrangements with any collaborative
partners on favorable terms, if at all. Any collaborative
relationships that we enter into may include restrictions on our
freedom to operate our business or may limit our revenues from
potential products. If a collaborative arrangement is
established, the collaborative partner may discontinue funding
any particular program or may, either alone or with others,
pursue alternative technologies or develop alternative drug
candidates for the diseases we are targeting. Competing
products, developed by a collaborative partner or to which a
collaborative partner has rights, may result in the
collaborative partner withdrawing support as to all or a portion
of our technology.
Without collaborative arrangements, we must fund our own
clinical development, manufacturing, and marketing and sales
activities, which accelerates the depletion of our cash and
requires us to develop our own manufacturing and marketing and
sales capabilities. Therefore, if we are unable to establish and
maintain collaborative arrangements and if other sources of cash
are not available, we will experience a severe adverse effect on
our ability to develop products and, if developed and approved,
to manufacture, market and sell them successfully.
Any regulatory
approvals that we may obtain for our product candidates may be
limited and subsequent issues regarding safety or efficacy could
cause us to remove products from the market.
If the FDA or foreign regulatory authorities grant approval of
Riquent or any of our other drug candidates, the approval may be
limited to specific conditions or patient populations, or
limited with respect to its distribution, including to specified
facilities or physicians with special training or experience.
The imposition of any of these restrictions or other
restrictions on the marketing and use of Riquent could adversely
affect any future sales of Riquent. Furthermore, even if a drug
candidate is approved, it is possible that a subsequent issue
regarding its safety or efficacy would require us to remove the
drug from the market.
Even if we
receive regulatory approval for our product candidates, we will
be subject to ongoing regulatory obligations and review,
including validation of our manufacturing facilities and
processes.
Following any regulatory approval of our product candidates, we
will be subject to continuing regulatory obligations such as
safety reporting requirements and additional post-marketing
obligations, including regulatory oversight of the promotion and
marketing of our products. In addition, we, and any third-party
manufacturers, will be required to adhere to regulations setting
forth cGMPs. These regulations cover all aspects of the
manufacturing, testing, quality control and record keeping
relating to our product candidates. Furthermore, we, and any
third-party manufacturers, will be subject to periodic
inspection by regulatory authorities. These inspections may
result in compliance issues that would require the expenditure
of significant financial or other resources to address. If we,
or any third-party manufacturers that we may engage, fail to
comply with applicable regulatory requirements, we may be
subject to fines, suspension or withdrawal of regulatory
approvals, product recalls, seizure of products, operating
restrictions and criminal prosecution.
S-11
Although a successful pre-approval inspection was conducted by
the FDA in July 2004, we have never operated a commercial
manufacturing facility. If we are unable to maintain validated
conditions at our manufacturing facilities or fail to
successfully validate our manufacturing processes to the
satisfaction of the regulatory authorities, they will not
approve Riquent for commercial use.
The size of the
market for our potential products is uncertain.
We estimate that the number of people who suffer from lupus in
the United States and Europe is potentially more than 1,000,000
and those with renal impairment, which Riquent is designed to
treat, is approximately 300,000. However, there is limited and
differing information available regarding the actual size of
these patient populations. In addition, it is uncertain whether
the results from previous or future clinical trials of Riquent
will be observed in broader patient populations, and the number
of patients who may benefit from Riquent may be significantly
smaller than the estimated patient populations. Furthermore,
management of patients with renal disease by specialists other
than nephrologists and rheumatologists is likely to reduce our
ability to access patients who may benefit from Riquent.
Our drugs may not
achieve market acceptance.
Even if Riquent or our other drug candidates receive regulatory
approval, patients and physicians may not readily or quickly
accept our proposed methods of treatment. In order for Riquent
or our other drug candidates to be commercially successful, we
will need to increase the awareness and acceptance of our drug
candidates among physicians, patients and the medical community.
Riquent is designed to be administered weekly by intravenous
injection. It is possible that providers and patients may resist
an intravenously administered therapeutic. It is also possible
that physician treatment practices may change and that the use
of other drugs, either newly approved or currently on the market
for other conditions, may become widely utilized by clinicians
for the treatment of patients with lupus and reduce the
potential use of Riquent in this patient population. In
addition, if we are unable to manufacture drugs at an acceptable
cost, physicians may not readily prescribe drugs that we may
manufacture due to cost-benefit considerations when compared to
other methods of treatment. If we are unable to achieve market
acceptance for approved products, our revenues and potential for
profitability will be negatively affected.
We lack
experience in marketing products for commercial sale.
In order to commercialize any drug candidate approved by the FDA
or foreign regulatory authorities, we must either develop
marketing and sales programs or enter into marketing
arrangements with others. If we cannot do either of these
successfully, we will not generate meaningful sales of any
products that may be approved. If we develop our own marketing
and sales capabilities, we will be required to employ a sales
force, establish and staff a customer service department, and
create or identify distribution channels for our drugs. We will
compete with other companies that have experienced and
well-funded marketing and sales operations. In addition, if we
establish our own sales and distribution capabilities, we will
incur material expenses and may experience delays or have
difficulty in gaining market acceptance for our drug candidates.
We currently have no marketing arrangements with others. There
can be no guarantee that, if we desire to, we will be able to
enter into any marketing agreements on favorable terms, if at
all, or that any such agreements will result in payments to us.
If we enter into co-promotion or other marketing and sales
arrangements with other companies, any revenues that we may
receive will be dependent on the efforts of others. There can be
no guarantee that these efforts will be successful.
We may not earn
as much revenue as we hope due to possible changes in healthcare
reimbursement policies.
The continuing efforts of government and healthcare insurance
companies to reduce the costs of healthcare may reduce the
amount of revenue that we can generate from sales of future
products, if any.
S-12
For example, in certain foreign markets, pricing and
profitability of prescription drugs are subject to government
control. In the United States, we expect that there will
continue to be a number of federal and state proposals to
implement similar government controls. In addition, an
increasing emphasis on managed care in the United States will
continue to put pressure on drug manufacturers to reduce prices.
Price control initiatives could reduce the revenue that we
receive for any products we may develop and sell in the future.
Moreover, even if Riquent were approved we cannot predict what
the dosage requirements or degree of efficacy would be and
therefore whether or not healthcare reimbursement policies would
enable a sales price that allows us to be profitable.
We have a history
of losses and may not become profitable.
We have incurred operating losses each year since our inception
in 1989 and had an accumulated deficit of approximately
$352.8 million as of December 31, 2007. We expect to
incur substantial losses each year for at least the next several
years as we conduct clinical trials of our drug candidates, seek
regulatory approval and continue our clinical development,
manufacturing, and regulatory activities. In addition, assuming
we ultimately receive approval from the FDA or foreign
regulatory authorities for Riquent or our other drug candidates,
we will be required to establish commercial manufacturing
capabilities and marketing and sales programs, which may result
in substantial additional losses. To achieve profitability we
must, among other matters, complete the development of our
products, obtain all necessary regulatory approvals and
establish commercial manufacturing, marketing and sales
capabilities. The amount of losses and the time required by us
to reach sustained profitability are highly uncertain and we may
never achieve profitability. We do not expect to generate
revenues from the sale of Riquent, if approved, or our other
products, if any, in the near term, and we may never generate
product revenues.
Our success in
developing and marketing our drug candidates depends
significantly on our ability to obtain patent protection for
Riquent and any other developed products. In addition, we will
need to successfully preserve our trade secrets and operate
without infringing on the rights of others.
We depend on patents and other unpatented intellectual property
to prevent others from improperly benefiting from products or
technologies that we may have developed. At April 15, 2008,
we owned 136 issued patents and have 37 pending patent
applications in the United States and in foreign countries.
These patents and patent applications cover various technologies
and drug candidates, including Riquent. There can be no
assurance, however, that any additional patents will be issued,
that the scope of any patent protection will be sufficient to
protect us or our technology, or that any current or future
issued patent will be held valid if subsequently challenged. We
are currently involved in an opposition proceeding in Europe
challenging the validity of certain claims in our European
patent relating to our antibody-mediated thrombosis drug
technology. There is a substantial backlog of biotechnology
patent applications at the United States Patent and Trademark
Office that may delay the review and issuance of any patents.
The patent position of biotechnology firms like ours is highly
uncertain and involves complex legal and factual questions, and
no consistent policy has emerged regarding the breadth of claims
covered in biotechnology patents or the protection afforded by
these patents. We intend to continue to file patent applications
as believed appropriate for patents covering both our products
and processes. There can be no assurance that patents will be
issued from any of these applications, or that the scope of any
issued patents will protect our technology.
We do not necessarily know if others, including competitors,
have patents or patent applications pending that relate to
compounds or processes that overlap or compete with our
intellectual property or which may affect our freedom to
operate. We are aware of certain families of patents and patent
applications that contain claims covering subject matter that
may affect our ability to develop, manufacture and sell our
products in the future. We have conducted investigations into
these patent families to determine what impact, if any, the
patent families could have on our continued development,
manufacture and, if approved by the FDA, sale of our drug
candidates, including Riquent. Based on our
S-13
investigations to date, we currently do not believe that these
patent families are likely to impede the advancement of our drug
candidates, including Riquent.
However, there can be no assurance that upon our further
investigation, these patent families or other patents will not
ultimately be found to impact the advancement of our drug
candidates, including Riquent. If the United States Patent and
Trademark Office or any foreign counterpart issues or has issued
patents containing competitive or conflicting claims, and if
these claims are valid, the protection provided by our existing
patents or any future patents that may be issued could be
significantly reduced, and our ability to prevent competitors
from developing products or technologies identical or similar to
ours could be negatively affected. In addition, there can be no
guarantee that we would be able to obtain licenses to these
patents on commercially reasonable terms, if at all, or that we
would be able to develop or obtain alternative technology. Our
failure to obtain a license to a technology or process that may
be required to develop or commercialize one or more of our drug
candidates may have a material adverse effect on our business.
In addition, we may have to incur significant expenses and
management time in defending or enforcing our patents.
We also rely on unpatented intellectual property such as trade
secrets and improvements, know-how, and continuing technological
innovation. While we seek to protect these rights, it is
possible that:
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others, including competitors, will develop inventions relevant
to our business;
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our confidentiality agreements will be breached, and we may not
have, or be successful in obtaining, adequate remedies for such
a breach; or
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our trade secrets will otherwise become known or be
independently discovered by competitors.
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We could incur substantial costs and devote substantial
management time in defending suits that others might bring
against us for infringement of intellectual property rights or
in prosecuting suits that we might bring against others to
protect our intellectual property rights.
The technology
underlying our products is uncertain and unproven.
All of our product development efforts are based on unproven
technologies and therapeutic approaches that have not been
widely tested or used. To date, no pharmaceutical products that
use our technology have been commercialized. The FDA has not
determined that we have proven Riquent to be safe and effective
in humans, and the technology on which it is based has been used
only in our pre-clinical tests and clinical trials. Clinical
trials of Riquent may be viewed as a test of our entire approach
to developing therapies for antibody-mediated diseases. If
Riquent does not work as intended, or if the data from our
clinical trials indicates that Riquent is not safe and
effective, the applicability of our technology for successfully
treating antibody-mediated diseases will be highly uncertain. As
a result, there is a significant risk that our therapeutic
approaches will not prove to be successful, and there can be no
guarantee that our drug discovery technologies will result in
any commercially successful products.
Because a number
of companies compete with us, many of which have greater
resources than we do, and because we face rapid changes in
technology in our industry, we cannot be certain that our
products will be accepted in the marketplace or capture market
share.
Competition from domestic and foreign biotechnology companies,
large pharmaceutical companies and other institutions is intense
and is expected to increase. A number of companies and
institutions are pursuing the development of pharmaceuticals in
our targeted areas. Many of these companies are very large, and
have financial, technical, sales and distribution and other
resources substantially greater than ours. The greater resources
of these competitors could enable them to develop competing
products more quickly than we are able to, and to market any
competing product more quickly or effectively so as to make it
extremely difficult for us to develop a share of the market for
our products. These competitors also include companies that are
conducting clinical trials and pre-clinical studies for the
treatment of lupus. Our competitors may develop or obtain
regulatory approval for products more rapidly than we do. If the
FDA were to approve a drug that is significantly similar in
structure to Riquent for the same
S-14
indication that Riquent is designed to treat, and such drug
received marketing exclusivity under the Orphan Drug Act, the
FDA may be prevented from approving Riquent. Also, the
biotechnology and pharmaceutical industries are subject to rapid
changes in technology. Our competitors may develop and market
technologies and products that are more effective or less costly
than those we are developing, or that would render our
technology and proposed products obsolete or noncompetitive.
We may not be
able to take advantage of the orphan drug designation for
Riquent.
In September 2000, the FDA granted us orphan drug designation
for Riquent for the treatment of lupus nephritis. The Orphan
Drug Act potentially enables us to obtain research funding and
tax credits for certain research expenses. In addition, the
Orphan Drug Act allows for seven years of exclusive marketing
rights to a specific drug for a specific orphan indication.
Exclusivity is conferred upon receipt of marketing approval from
the FDA to the first sponsor who obtains such approval for a
designated drug. The marketing exclusivity prevents FDA approval
during the seven-year period of the same drug, as defined in the
FDA regulations, from another company for the same orphan
indication. Whether we will be able to take advantage of some of
the benefits afforded by the orphan drug designation will
ultimately be determined by the FDA only after further review of
our NDA.
The use of
Riquent or other potential products in clinical trials, as well
as the sale of any approved products, may expose us to lawsuits
resulting from the use of these products.
The use and possible sale of Riquent or other potential products
may expose us to legal liability and negative publicity if we
are subject to claims that our products harmed people. These
claims might be made directly by patients, pharmaceutical
companies, or others. We currently maintain $10.0 million
of product liability insurance for claims arising from the use
of our products in clinical trials. However, product liability
insurance is becoming increasingly expensive. In addition, in
the event of any commercialization of any of our products, we
will likely need to obtain additional insurance, which will
increase our insurance expenses. There can be no guarantee that
we will be able to maintain insurance or that insurance can be
acquired at a reasonable cost, in sufficient amounts, or with
broad enough coverage to protect us against possible losses.
Furthermore, it is possible that our financial resources would
be insufficient to satisfy potential product liability or other
claims. A successful product liability claim or series of claims
brought against us could negatively impact our business and
financial condition.
We face
environmental liabilities related to certain hazardous materials
used in our operations.
Due to the nature of our manufacturing processes, we are subject
to stringent federal, state and local laws governing the use,
handling and disposal of certain materials and wastes. We may
have to incur significant costs to comply with environmental
regulations if and when our manufacturing increases to
commercial volumes. Current or future environmental laws may
significantly affect our operations because, for instance, our
production process may be required to be altered, thereby
increasing our production costs. In our research and
manufacturing activities, we use radioactive and other materials
that could be hazardous to human health, safety or the
environment. These materials and various wastes resulting from
their use are stored at our facility pending ultimate use and
disposal. The risk of accidental injury or contamination from
these materials cannot be eliminated. In the event of such an
accident, we could be held liable for any resulting damages, and
any such liability could exceed our resources. Although we
maintain general liability insurance, we do not specifically
insure against environmental liabilities.
We may have
experienced an ownership change that could result in
a significant reduction in our available net operating loss and
research tax credit carryforwards.
At December 31, 2007, we had federal and California income
tax net operating loss carryforwards of approximately
$316.1 million and $169.4 million, respectively. In
addition, we had federal and California research and development
tax credit carryforwards of $15.3 million and
$8.9 million,
S-15
respectively. The federal net operating loss and research tax
credit carryforwards will begin to expire in 2008 unless
previously utilized. The California net operating loss
carryforwards will begin to expire in 2009 unless previously
utilized. The California research and development credit
carryforwards will carry forward indefinitely until utilized.
Our ability to use these net operating loss and research tax
credit carryforwards to offset future taxable income will be
limited under Section 382 of the Internal Revenue Code of
1986, as amended, if it is determined that we have experienced,
or if we in the future experience, an ownership
change. We are currently analyzing whether such an
ownership change has occurred in the past. We expect this
analysis to be completed within the next twelve months. If it is
determined that we have experienced an ownership change in the
past, or if such a change occurs as a result of this offering,
we may not be able to utilize a significant portion of these net
operating loss and research tax credit carryforwards to offset
future income. Our inability to fully utilize our net operating
loss and research tax credit carryforwards could have a negative
impact on our tax assets, financial position and future results
of operations.
RISK FACTORS
RELATED SPECIFICALLY TO OUR STOCK
The ownership of
our common stock is concentrated.
As of March 31, 2008, our three largest stockholders
beneficially owned approximately 48% of our currently
outstanding shares of common stock. If these stockholders or any
of their affiliated investment funds purchase
$ million
of stock and warrants in this offering as they have indicated,
after this offering they will beneficially
own %
of our shares. Investors who purchase our common stock may be
subject to certain risks due to the concentrated ownership of
our common stock. For example, the sale by any of our large
stockholders of a significant portion of that stockholders
holdings could have a material adverse effect on the market
price of our common stock. In addition, two of these
stockholders have the ability, either alone or jointly, to
appoint four members of our board of directors. Accordingly,
these two stockholders, either directly or indirectly, have the
ability to significantly influence the outcome of all matters
submitted to a vote of our stockholders.
Our common stock
price is volatile and may decline even if our business is doing
well.
The market price of our common stock has been and is likely to
continue to be highly volatile. Market prices for securities of
biotechnology and pharmaceutical companies, including ours, have
historically been highly volatile, and the market has from time
to time experienced significant price and volume fluctuations
that are unrelated to the operating performance of particular
companies. The following factors, among others, can have a
significant effect on the market price of our securities:
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|
Ø
|
limited financial resources;
|
|
Ø
|
our clinical trial results;
|
|
Ø
|
future sales of significant amounts of our common stock by us or
our stockholders;
|
|
Ø
|
actions or decisions by the FDA and other comparable agencies;
|
|
Ø
|
announcements of technological innovations or new therapeutic
products by us or others;
|
|
Ø
|
developments in patent or other proprietary rights;
|
|
Ø
|
public concern as to the safety of drugs discovered or developed
by us or others;
|
|
Ø
|
developments concerning potential agreements with collaborators;
|
|
Ø
|
comments by securities analysts and general market
conditions; and
|
|
Ø
|
government regulation, including any legislation that may impact
the price of any commercial products that we may seek to sell.
|
The realization of any of the risks described in these
Risk factors could have a negative effect on the
market price of our common stock.
S-16
Future sales of
our stock by our stockholders could negatively affect the market
price of our stock.
Sales of our common stock in the public market, or the
perception that such sales could occur, could result in a drop
in the market price of our securities. As of March 31,
2008, there were:
|
|
Ø
|
Approximately 39,660,730 shares of common stock that have
been issued in registered offerings or were otherwise freely
tradable in the public markets.
|
|
Ø
|
Approximately 10,761 shares of common stock eligible for
resale in the public market pursuant to SEC Rule 144.
|
|
Ø
|
4,399,992 shares of common stock underlying warrants that
have been registered for resale under a Registration Statement
on
Form S-3.
|
|
Ø
|
5,443,354 shares of common stock that may be issued on the
exercise of outstanding stock options granted under our various
stock option plans at a weighted average exercise price of $7.80
per share.
|
|
Ø
|
Approximately 351,765 shares of common stock reserved for
future issuance pursuant to awards granted under our equity
incentive and employee stock purchase plans, which shares are
covered by effective registration statements under the
Securities Act of 1933, as amended (the Securities
Act).
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|
Ø
|
Pursuant to a registration statement on
Form S-3
filed on December 10, 2002, we registered an aggregate
amount of $125,000,000 of our common stock for issuance from
time to time. As of February 29, 2008, there was
$13,917,500 of our common stock available for future issuance
under this registration statement, which expires on
December 1, 2008. We expect to use the entire amount
remaining for future issuance under this registration statement
in connection with this offering.
|
|
Ø
|
Pursuant to a registration statement on
Form S-3
filed on August 20, 2007, we registered an aggregate amount
of $77,000,000 of our common stock, preferred stock and warrants
for issuance from time to time. After this offering,
approximately
$ million
of our common stock, preferred stock and warrants will be
available for sale under this registration statement, which
expires on August 23, 2010.
|
We cannot estimate the number of shares of common stock that may
actually be sold in the public market because this will depend
on the market price for our common stock, the individual
circumstances of the sellers and other factors. We also have a
number of stockholders that own significant blocks of our common
stock. If these stockholders sell significant portions of their
holdings in a relatively short time, for liquidity or other
reasons, the market price of our common stock could drop
significantly.
Our stock may be
removed from listing on the Nasdaq Global Market and may not
qualify for listing on any stock exchange, in which case it may
be difficult to maintain a market in our stock.
In 2005, we received a notice from the Nasdaq Stock Market that
our stock price fell below the required minimum bid price. We
have since regained compliance with the minimum bid price rule,
but we are required to maintain compliance in order to maintain
our listing. In addition to the minimum bid price rule, the
Nasdaq Global Market has several other continued listing
requirements. Failure to maintain compliance with any Nasdaq
listing requirement could cause our stock to be removed from
listing on Nasdaq. If this were to happen, we may not be able to
secure listing on other exchanges or quotation systems. If our
stock is no longer traded on an exchange or quotation system, it
may be difficult for our stockholders to sell the shares that
they own. This would have a negative effect on the price and
liquidity of our stock.
S-17
Failure to
achieve and maintain effective internal control over financial
reporting in accordance with Section 404 of the
Sarbanes-Oxley Act could have a material adverse effect on our
business and stock price.
Section 404 of the Sarbanes-Oxley Act requires us to
evaluate annually the effectiveness of our internal controls
over financial reporting as of the end of each fiscal year
beginning in 2004 and to include a management report assessing
the effectiveness of our internal control over financial
reporting in all future annual reports beginning with the annual
report on
Form 10-K
for the fiscal year ended December 31, 2004.
Section 404 also requires our independent registered public
accounting firm to report on our internal control over financial
reporting. We evaluated our internal control over financial
reporting as of December 31, 2007 in order to comply with
Section 404 and concluded that our disclosure controls and
procedures were effective as of such date. If we fail to
maintain the adequacy of our internal controls, as such
standards are modified, supplemented or amended from time to
time, we cannot provide any assurances that we will be able to
conclude in the future that we have effective internal control
over financial reporting in accordance with Section 404. If
we fail to achieve and maintain a system of effective internal
control over financial reporting, it could have a material
adverse effect on our business and stock price.
There is no
public market for the warrants to purchase common stock in this
offering.
There is no established public trading market for the warrants
being offered in this offering, and we do not expect a market to
develop. In addition, we do not intend to apply for listing the
warrants on any securities exchange. Without an active market,
the liquidity of the warrants will be limited.
Anti-takeover
devices may prevent changes in our board of directors and
management.
We have in place several anti-takeover devices, including a
stockholder rights plan, which may have the effect of delaying
or preventing changes in our management or deterring third
parties from seeking to acquire significant positions in our
common stock. For example, one anti-takeover device provides for
a board of directors that is separated into three classes, with
their terms in office staggered over three-year periods. This
has the effect of delaying a change in control of our board of
directors without the cooperation of the incumbent board. In
addition, our bylaws require stockholders to give us written
notice of any proposal or director nomination within a specified
period of time prior to the annual stockholder meeting,
establish certain qualifications for a person to be elected or
appointed to the board of directors during the pendency of
certain business combination transactions, and do not allow
stockholders to call a special meeting of stockholders.
We may also issue shares of preferred stock without further
stockholder approval and upon terms that our board of directors
may determine in the future. The issuance of preferred stock
could have the effect of making it more difficult for a third
party to acquire a majority of our outstanding stock, and the
holders of such preferred stock could have voting, dividend,
liquidation and other rights superior to those of holders of our
common stock.
S-18
Use of proceeds
We estimate that the net proceeds to us from the sale of our
securities offered by this prospectus supplement will be
approximately
$ million
after deducting underwriting discounts and commissions and
estimated offering expenses. We intend to use the net proceeds
we receive to fund the ongoing clinical trials of Riquent,
including the production of drug for the clinical trials, to
expand and validate our existing facilities, processes and
infrastructures, and for other general corporate purposes. The
amounts and timing of expenditures may vary significantly
depending on several factors, including the results of our
clinical trials, the progress of our research and development
efforts and the time and costs of obtaining regulatory
approvals, our future capital expenditures, our need to develop
commercial marketing and sales capabilities, and our ability to
generate revenues in the future.
We expect that the net proceeds to us from this offering,
together with our other cash resources, excluding the value of
our currently illiquid auction rate securities, will enable us
to continue our operations through December 31, 2008, based
on our current estimates of the costs of conducting the Phase 3
ASPEN study and otherwise operating our business. This is well
before we would be able to commercialize Riquent, even if the
Phase 3 ASPEN study is successful. Because we will
therefore not generate product revenue from Riquent prior to
exhausting our cash resources after this offering, we will need
to obtain additional external financing, through the sale of
equity or debt securities, through a collaboration or licensing
agreement with a third party or otherwise, to continue our
operations. We may seek to complete any such financing at any
time in 2008, depending largely on market conditions, partnering
opportunities and other factors not under our control. If we
cannot raise additional financing, we would need to either halt
operations or sell or license our assets, including our Riquent
program, to one or more third parties. See Risk
factors for more information on our cash needs.
S-19
Dilution
The net tangible book value of our common stock on
December 31, 2007 was $30.9 million, or approximately
$0.78 per share, based on 39,629,660 shares outstanding as
of December 31, 2007. Net tangible book value per share
represents the amount of our total tangible assets, less our
total liabilities, divided by the total number of shares of our
common stock outstanding. Dilution in net tangible book value
per share to new investors represents the difference between the
amount per share paid by purchasers of units in this offering
and the net tangible book value per share of our common stock
immediately afterwards. Without taking into account any other
changes in net tangible book value after December 31, 2007,
other than to give effect to the sale
of shares
of common stock being sold by us in this offering and after
deducting underwriting discounts and commissions and estimated
offering expenses payable by us, our net tangible book value
would have been
$ million,
or approximately
$
per share based
on shares
outstanding. This represents an immediate increase in net
tangible book value of
$
per share to existing stockholders and an immediate dilution in
net tangible book value of
$
per share to new investors.
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|
|
|
|
|
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|
Public offering price per unit
|
|
|
|
|
|
$
|
|
|
Net tangible book value per share as of December 31, 2007
|
|
$
|
0.78
|
|
|
|
|
|
Increase per share attributable to new investors
|
|
$
|
|
|
|
|
|
|
As adjusted net tangible book value per share after the offering
|
|
|
|
|
|
$
|
|
|
Dilution in net tangible book value per share to new investors
|
|
|
|
|
|
$
|
|
|
This table excludes 4,809,576 shares of common stock
issuable upon exercise of stock options outstanding as of
December 31, 2007 at a weighted average exercise price of
$8.56 per share (2,808,588 were exercisable as of
December 31, 2007 and the balance becomes exercisable in
the future based upon continued employment),
4,399,992 shares of common stock issuable upon exercise of
warrants outstanding as of December 31, 2007 at an exercise
price of $5.00 per share and any shares that we may issue in the
future pursuant to the registration statement of which this
prospectus supplement forms a part.
The foregoing dilution information does not give effect to the
exercise of the warrants that are being offered with the units.
S-20
Selected
consolidated financial data
The consolidated statements of operations and balance sheet data
as of and for the years ended December 31, 2005, 2006 and
2007 are derived from our audited consolidated financial
statements and related notes which are incorporated by reference
into this prospectus supplement. The historical results
presented are not necessarily indicative of results to be
expected from any future period. The following selected
financial data should be read in conjunction with, and is
qualified by reference to, Risk factors included in
this prospectus supplement and Managements
Discussion and Analysis of Financial Condition and Results of
Operations and our consolidated financial statements and
related notes which are incorporated by reference into this
prospectus supplement.
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
Year Ended
December 31,
|
|
|
|
2005
|
|
|
2006
|
|
|
2007
|
|
|
|
|
|
(in thousands,
except per share data)
|
|
|
Consolidated Statements of Operations Data:
|
|
|
|
|
Expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development
|
|
$
|
22,598
|
|
|
$
|
32,938
|
|
|
$
|
46,635
|
|
General and administrative
|
|
|
5,405
|
|
|
|
9,287
|
|
|
|
9,058
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
(28,003
|
)
|
|
|
(42,225
|
)
|
|
|
(55,693
|
)
|
Interest expense
|
|
|
(116
|
)
|
|
|
(46
|
)
|
|
|
(82
|
)
|
Interest income
|
|
|
756
|
|
|
|
2,826
|
|
|
|
2,699
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
$
|
(27,363
|
)
|
|
$
|
(39,445
|
)
|
|
$
|
(53,076
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share
|
|
$
|
(1.77
|
)
|
|
$
|
(1.21
|
)
|
|
$
|
(1.40
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share
|
|
|
15,446
|
|
|
|
32,588
|
|
|
|
37,818
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and short-term investments
|
|
$
|
72,877
|
|
|
$
|
42,909
|
|
|
$
|
39,359
|
|
Working capital
|
|
$
|
70,124
|
|
|
$
|
37,673
|
|
|
$
|
29,881
|
|
Total assets
|
|
$
|
80,928
|
|
|
$
|
49,525
|
|
|
$
|
44,405
|
|
Noncurrent portion of obligations under capital leases and notes
payable
|
|
$
|
142
|
|
|
$
|
196
|
|
|
$
|
388
|
|
Stockholders equity
|
|
$
|
77,130
|
|
|
$
|
43,089
|
|
|
$
|
33,521
|
|
S-21
Description of
capital stock
The following is a description of our capital stock. The
following summary of our amended and restated certificate of
incorporation, amended and restated bylaws, and rights plan does
not describe the certificate, the bylaws, or the rights plan
entirely. We urge you to read our certificate, bylaws, and
rights plan, which are incorporated by reference herein. See
Where you can find more information and incorporation by
reference on
page S-31.
On the date of this prospectus supplement, our authorized
capital stock consists of 225,000,000 shares of common
stock, $0.01 par value per share, and 8,000,000 shares
of preferred stock, $0.01 par value per share.
COMMON
STOCK
Voting Rights. Holders of our common stock are entitled
to one vote per share on all matters to be voted upon by our
stockholders. The vote of the holders of a majority of the stock
represented at a meeting at which a quorum is present is
generally required to take stockholder action, unless a greater
vote is required by law or specifically required by our
certificate of incorporation or bylaws. Special stockholder
meetings may be called only by the board of directors, the
chairman of the board or the president. Our certificate of
incorporation provides that our stockholders may not act by
written consent. In addition, our bylaws include an advance
notice procedure with regard to the nomination, other than by or
at the direction of the board of directors, of candidates for
election as directors and with regard to matters to be brought
before an annual meeting or special meeting of stockholders.
Dividends and Other Rights. Holders of our common stock
are entitled to receive, as when and if declared by the board of
directors from time to time, such dividends and other
distributions in cash, stock or property from our assets or
funds legally available for such purposes subject to any
dividend preferences that may be attributable to preferred stock
that may be authorized. In the event of our liquidation,
dissolution or winding up, after all liabilities and the holders
of each series of preferred stock, if any, have been paid in
full, the holders of our common stock are entitled to share
ratably in all remaining assets available for distribution. Our
common stock has no preemptive, subscription, redemption or
conversion rights. There are no sinking fund provisions
applicable to our common stock. All outstanding shares of our
common stock are, and all shares of our common stock outstanding
on the closing of this offering will be, fully paid and
non-assessable.
Classified Board of Directors. Our certificate of
incorporation and bylaws provide for a classified board of
directors. Our board is classified into three classes, each as
nearly equal in number as possible. At each annual meeting, the
successors to the class of directors whose term expire at that
meeting are elected for a term of office to expire at the third
succeeding annual meeting after their election or until their
successors have been duly elected and qualified. Delaware law
provides that, unless the certificate of incorporation provides
otherwise, directors serving on a classified board of directors
may be removed only for cause. Our certificate of incorporation
does not provide otherwise. Therefore, our directors may only be
removed for cause. The affirmative vote of the holders of 75% or
more of the total voting power of all outstanding shares of
voting stock would be required to amend our certificate of
incorporation or bylaws to remove the classified board
provisions.
Rights Plan. Each outstanding share of our common stock
is accompanied by a right to purchase our preferred stock, our
common stock or the common stock of a successor company pursuant
to the terms of a rights agreement. Please refer to the
discussion entitled La Jolla Pharmaceutical Company
Rights Plan below.
Delaware Takeover Statute. We are subject to the
provisions of Section 203 of the Delaware General
Corporation Law. In general, the statute prohibits a publicly
held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three
years after the date of the transaction in which the person
became an interested stockholder, unless the business
combination is approved in a prescribed manner. For purposes of
Section 203, a business combination includes a merger,
asset sale or other transaction resulting in a financial benefit
to the interested stockholder. An interested stockholder is a
person who, together with affiliates and associates, owns (or
within three
S-22
years prior, did own) 15% or more of the corporations
voting stock. Delaware law, the existence of our rights
agreement, and the provisions of our certificate of
incorporation and bylaws may have the effect of deterring
hostile takeovers or delaying changes in control of our
management, which could depress the market price of our common
stock.
Transfer Agent. American Stock Transfer &
Trust Company is the Transfer Agent and Registrar for the
shares of our common stock.
PREFERRED
STOCK
Our board of directors has the authority, without further action
by stockholders, to issue up to 8,000,000 shares of
preferred stock in one or more series and to fix the powers,
designations, rights, preferences, privileges, qualifications,
and restrictions thereof, including dividend rights, conversion
rights, voting rights, rights and terms of redemption,
liquidation preferences and sinking fund terms, any or all of
which may be greater than the rights of our common stock. Our
board of directors, without further stockholder approval, can
issue preferred stock with voting, conversion, and other rights
that could adversely affect the voting power and other rights of
the holders of common stock. The issuance of preferred stock in
certain circumstances may have the effect of delaying, deferring
or preventing a change in control of La Jolla
Pharmaceutical Company, may discourage bids for our common stock
at a premium over the market price of the common stock, and may
adversely affect the market price of our common stock. As of the
date of this prospectus supplement, there are no shares of our
preferred stock outstanding.
We have filed a certificate of designation with the Secretary of
State of the State of Delaware, which designates
100,000 shares of preferred stock as Series A Junior
Participating Preferred Stock in connection with our stockholder
rights plan, as described below. We refer to our Series A
Junior Participating Preferred Stock as our Series A
Preferred Shares. Except to the extent that a right to purchase
our Series A Preferred Shares accompanies each share of our
common stock, no shares of our preferred stock are covered by
this prospectus supplement.
LA JOLLA
PHARMACEUTICAL COMPANY RIGHTS PLAN
On November 19, 1998, our board of directors authorized and
declared a dividend of one right for each share of our common
stock. On December 3, 1998, we entered into a rights
agreement with American Stock Transfer &
Trust Company, as rights agent, and filed a Certificate of
Designation with the State of Delaware regarding our
Series A Preferred Shares. The Company paid the rights
dividend to the holders of record of common stock as of the
close of business on December 18, 1998. Common stock
certificates issued after December 18, 1998, and prior to
the Distribution Date (as defined in the rights agreement),
contain a notation incorporating the rights agreement by
reference. The rights agreement was subsequently amended to
eliminate the concept of continuing directors in
response to a clarification of Delaware law and to permit
certain stockholders to acquire more than 15% of our outstanding
common stock without triggering the rights agreement by amending
the definition of an acquiring person. Currently,
there are no separate rights certificates. Each right is
attached to each share of our common stock and trades
automatically with the common stock. Rights will not be
separable from common stock or exercisable, unless specified
events described in the rights agreement occur. Upon the
occurrence of the events described in the rights agreement, the
rights will separate from the common stock and may thereafter
become exercisable to purchase additional securities.
We have received indications from certain of our principal
stockholders Essex Woodlands Health Ventures
Fund VI, L.P., Frazier Healthcare V, L.P. and
Alejandro Gonzalez of their intent to offer to
purchase, either directly or through one or more of their
affiliated investment funds, approximately
$ million,
or %, of the units in this
offering. If these stockholders offer to purchase these units,
we expect that the underwriters will confirm orders to them in
such an amount, and that immediately after the completion of
this offering, Essex Woodlands Health Ventures Fund VI,
L.P. (and its affiliates), Frazier Healthcare V, L.P. (and
its affiliates) and Alejandro Gonzalez (and his affiliates) will
beneficially own
approximately %, %
and %, respectively, of our
outstanding
S-23
common stock, including the shares issuable to these
stockholders under the warrants to be sold in this offering.
Under the terms of the rights agreement, if Essex Woodlands
Health Ventures Fund VI, L.P. (and its affiliates), Frazier
Healthcare V, L.P. (and its affiliates) and Alejandro
Gonzalez (and his affiliates) purchase units in this offering in
the amounts described above, each such stockholder would become
an acquiring person under the rights agreement and
would trigger the rights issued thereunder. In order to avoid
triggering the rights issued under the rights plan in connection
with this offering, we expect to amend the rights agreement upon
the completion of this offering to allow Essex Woodlands Health
Ventures Fund VI, L.P. (and its affiliates), Frazier
Healthcare V, L.P. (and its affiliates) and Alejandro
Gonzalez (and his affiliates) to beneficially own up
to %, %
and %, respectively, of our
outstanding common stock, in each case, without becoming an
acquiring person under the agreement.
Description of
warrants
The material terms and provisions of the warrants being offered
pursuant to this prospectus supplement and the accompanying
prospectuses are summarized below. This summary is subject to,
and qualified in its entirety by, the form of warrant, which
will be provided to each purchaser in this offering and will be
filed on a Current Report on
Form 8-K
in connection with this offering.
The warrants will be exercisable at any time and from time to
time for a period of five years from issuance. The warrants will
be exercisable, at the option of each holder, upon the surrender
of the warrants to us and at an exercise price equal to
$
per share, which, except as described below, must be paid in
cash at the time of exercise. The exercise price is subject to
appropriate adjustment in the event of stock dividends, stock
splits, reorganizations or similar events affecting our common
stock. The warrant holders must surrender payment in cash of the
exercise price of the shares being acquired upon exercise of the
warrants; provided, however, that if the Company is unable to
offer and sell the shares underlying these warrants pursuant to
this prospectus supplement due to the ineffectiveness of the
registration statements of which this prospectus supplement is a
part, then the warrants may only be exercised on a
net or cashless basis. In no event is
the warrant holder entitled to a cash settlement from the
Company upon exercise. The warrants will be freely transferable
by their holders. However, there is no established public
trading market for the warrants and we do not intend to apply
for listing of the warrants on any securities exchange.
In the event that the trading price of our common stock closes
above 200% of the exercise price of the warrant for 10 days
in any
30-day
period during the warrant term, we can then send a redemption
notice to the warrant holders. This redemption notice will
provide the warrant holders with at least 30 days to
exercise outstanding warrants, after which time we may redeem
and cancel any unexercised warrants for nominal consideration.
No warrant agent will be engaged in connection with the issuance
of the warrants. The warrants will not be issued under a
separate warrant agreement between us and any warrant agent. The
warrants will settle on or after May , 2008 by
physical delivery. The warrants may be exercised as described
above at the principal executive offices of the Company. Upon
receipt of payment and the warrant certificate properly
completed and duly executed at our principal executive offices,
we will, as soon as practicable, forward the shares of common
stock to be issued upon exercise. If less than all of the
warrants represented by the warrant certificate are exercised, a
new warrant certificate will be issued for the remaining
warrants.
S-24
Underwriting
We are offering the units described in this prospectus
supplement through the underwriters named below with each unit
consisting of one share of our common stock and one warrant to
purchase shares
of our common stock. UBS Securities LLC and Canaccord Adams Inc.
are the representatives of the underwriters and are joint
book-running managers of this offering.
We have entered into an underwriting agreement with the
underwriters. Subject to the terms and conditions of the
underwriting agreement, each of the underwriters has severally
agreed to purchase the number of units listed next to its name
in the following table:
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Number of
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Underwriters
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Units
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UBS Securities LLC
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Canaccord Adams Inc.
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Total
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The underwriting agreement provides that the underwriters must
buy all of the units if they buy any of them. However, the
underwriters are not required to take or pay for the units
covered by the underwriters over-allotment option
described below.
The units are offered subject to a number of conditions,
including:
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receipt and acceptance of the units by the underwriters, and
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the underwriters right to reject orders in whole or in
part.
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In connection with this offering, certain of the underwriters or
securities dealers may distribute prospectuses electronically.
OVER-ALLOTMENT
OPTION
We have granted the underwriters an option to buy up to an
aggregate
of additional
units. The underwriters may exercise this option solely for the
purpose of covering over-allotments, if any, made in connection
with this offering. The underwriters have 30 days from the
date of this prospectus supplement to exercise this option. If
the underwriters exercise this option, they will each purchase
additional units approximately in proportion to the amounts
specified in the table above.
The following table shows the per unit and total underwriting
discounts and commissions we will pay to the underwriters
assuming both no exercise and full exercise of the
underwriters option to purchase up to an
additional units.
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No
exercise
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Full
exercise
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Per unit
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$
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Total
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$
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In connection with this offering, we have granted to each of the
underwriters certain rights to participate in future
transactions with us. In accordance with the Conduct Rules of
Financial Industry Regulatory Authority, FINRA deems each of
these rights to represent 1% in underwriting compensation for
this offering.
We estimate that the total expenses of this offering payable by
us, not including the underwriting discounts and commissions,
will be approximately
$ .
NO SALES OF
SIMILAR SECURITIES
We, our executive officers and our directors have entered into
lock-up
agreements with the underwriters. Under these agreements,
subject to certain exceptions, including our right to issue
common stock or other equity securities in connection with a
corporate partnership for Riquent, we
S-25
may not, without the prior written approval of UBS Securities
LLC and Canaccord Adams Inc., and our executive officers and
directors may not, without the prior written approval of UBS
Securities LLC, offer, sell, contract to sell or otherwise
dispose of, directly or indirectly, or hedge our common stock or
securities convertible into or exchangeable or exercisable for
our common stock. These restrictions will be in effect for a
period of 90 days after the date of this prospectus
supplement. At any time and without public notice, UBS
Securities LLC and Canaccord Adams Inc., as applicable, may in
their sole discretion, release some or all of the securities
from these
lock-up
agreements.
INDEMNIFICATION
We have agreed to indemnify the underwriters against certain
liabilities, including certain liabilities under the Securities
Act. If we are unable to provide this indemnification, we have
agreed to contribute to payments the underwriters may be
required to make in respect of those liabilities.
NASDAQ GLOBAL
MARKET QUOTATION
Our common stock is quoted on The Nasdaq Global Market under the
trading symbol LJPC.
PRICE
STABILIZATION, SHORT POSITIONS PASSIVE MARKET MAKING
In connection with this offering, the underwriters may engage in
activities that stabilize, maintain or otherwise affect the
price of our common stock, including:
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stabilizing transactions;
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short sales;
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purchases to cover positions created by short sales;
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imposition of penalty bids;
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syndicate covering transactions; and
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passive market making.
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Stabilizing transactions consist of bids or purchases made for
the purpose of preventing or retarding a decline in the market
price of our common stock while this offering is in progress.
These transactions may also include making short sales of our
common stock, which involve the sale by the underwriters of a
greater number of units than they are required to purchase in
this offering, and purchasing shares of common stock on the open
market to cover positions created by short sales. Short sales
may be covered short sales, which are short
positions in an amount not greater than the underwriters
over-allotment option referred to above, or may be naked
short sales, which are short positions in excess of that
amount.
The underwriters may close out any covered short position by
either exercising their over-allotment option, in whole or in
part, or by purchasing securities in the open market. In making
this determination, the underwriters will consider, among other
things, the price of securities available for purchase in the
open market as compared to the price at which they may purchase
securities through the over-allotment option.
Naked short sales are in excess of the over-allotment option.
The underwriters must close out any naked short position by
purchasing securities in the open market. A naked short position
is more likely to be created if the underwriters are concerned
that there may be downward pressure on the price of our common
stock in the open market that could adversely affect investors
who purchased in this offering.
The underwriters also may impose a penalty bid. This occurs when
a particular underwriter repays to the underwriters a portion of
the underwriting discount received by it because the
representatives have repurchased securities sold by or for the
account of that underwriter in stabilizing or short covering
transactions.
S-26
As a result of these activities, the price of our securities may
be higher than the price that otherwise might exist in the open
market. If these activities are commenced, they may be
discontinued by the underwriters at any time. The underwriters
may carry out these transactions on The Nasdaq Global Market, in
the over-the-counter market or otherwise.
In addition, in connection with this offering, certain of the
underwriters (and selling group members) may engage in passive
market making transactions in our common stock on the Nasdaq
Global Market prior to the pricing and completion of this
offering. Passive market making consists of displaying bids on
the Nasdaq Global Market no higher than the bid prices of
independent market makers and making purchases at prices no
higher than these independent bids and effected in response to
order flow. Net purchases by a passive market maker on each day
are generally limited to a specified percentage of the passive
market makers average daily trading volume in the common
stock during a specified period and must be discontinued when
such limit is reached. Passive market making may cause the price
of our common stock to be higher than the price that otherwise
would exist in the open market in the absence of these
transactions. If passive market making is commenced, it may be
discontinued at any time.
AFFILIATIONS
Certain of the underwriters and their affiliates may from time
to time provide certain commercial banking, financial advisory,
investment banking and other services for us for which they were
and will be entitled to receive separate fees. The underwriters
and their affiliates may from time to time in the future engage
in transactions with us and perform services for us in the
ordinary course of their business.
S-27
Notice to investors
EUROPEAN ECONOMIC
AREA
In relation to each Member State of the European Economic Area,
or EEA, which has implemented the Prospectus Directive (each, a
Relevant Member State), with effect from and including the date
on which the Prospectus Directive is implemented in that
Relevant Member State, or the Relevant Implementation Date, our
common stock will not be offered to the public in that Relevant
Member State prior to the publication of a prospectus in
relation to our common stock that has been approved by the
competent authority in that Relevant Member State or, where
appropriate, approved in another Relevant Member State and
notified to the competent authority in that Relevant Member
State, all in accordance with the Prospectus Directive, except
that, with effect from and including the Relevant Implementation
Date, our common stock may be offered to the public in that
Relevant Member State at any time:
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to legal entities which are authorized or regulated to operate
in the financial markets or, if not so authorized or regulated,
whose corporate purpose is solely to invest in securities;
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to any legal entity which has two or more of (1) an average
of at least 250 employees during the last financial year;
(2) a total balance sheet of more than 43,000,000 and
(3) an annual net turnover of more than 50,000,000,
as shown in its last annual or consolidated accounts; or
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in any other circumstances which do not require the publication
by us of a prospectus pursuant to Article 3 of the
Prospectus Directive.
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As used above, the expression offered to the public
in relation to any of our common stock in any Relevant Member
State means the communication in any form and by any means of
sufficient information on the terms of the offer and our common
stock to be offered so as to enable an investor to decide to
purchase or subscribe for our common stock, as the same may be
varied in that Member State by any measure implementing the
Prospectus Directive in that Member State and the expression
Prospectus Directive means Directive 2003/71/ EC and
includes any relevant implementing measure in each Relevant
Member State.
The EEA selling restriction is in addition to any other selling
restrictions set out below.
UNITED
KINGDOM
Our common stock may not be offered or sold and will not be
offered or sold to any persons in the United Kingdom other than
to persons whose ordinary activities involve them in acquiring,
holding, managing or disposing of investments (as principal or
as agent) for the purposes of their businesses and in compliance
with all applicable provisions of the Financial Services and
Markets Act 2000, or the FSMA, with respect to anything done in
relation to our common stock in, from or otherwise involving the
United Kingdom. In addition, each underwriter has only
communicated or caused to be communicated and will only
communicate or cause to be communicated any invitation or
inducement to engage in investment activity (within the meaning
of Section 21 of the FSMA) received by it in connection
with the issue or sale of our common stock in circumstances in
which Section 21(1) of the FSMA does not apply to us.
Without limitation to the other restrictions referred to herein,
this prospectus is directed only at (1) persons outside the
United Kingdom, (2) persons having professional experience
in matters relating to investments who fall within the
definition of investment professionals in
Article 19(5) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005; or (3) high net
worth bodies corporate, unincorporated associations and
partnerships and trustees of high value trusts as described in
Article 49(2) of the Financial Services and Markets Act
2000 (Financial Promotion) Order 2005. Without limitation to the
other restrictions referred to herein, investment or investment
activity to which this prospectus relates is available only to,
and will be engaged in only with, such persons, and persons
within the United Kingdom who receive this communication (other
than persons who fall within (2) or (3) above) should
not rely or act upon this communication.
S-28
FRANCE
No prospectus (including any amendment, supplement or
replacement thereto) has been prepared in connection with the
offering of our common stock that has been approved by the
Autorité des marchés financiers or by the competent
authority of another State that is a contracting party to the
Agreement on the European Economic Area and notified to the
Autorité des marchés financiers; no common stock has
been offered or sold and will be offered or sold, directly or
indirectly, to the public in France except to permitted
investors, consisting of persons licensed to provide the
investment service of portfolio management for the account of
third parties, qualified investors (investisseurs
qualifiés) acting for their own account
and/or
corporate investors meeting one of the four criteria provided in
Article 1 of Decree N7
2004-1019 of
September 28, 2004 and belonging to a limited circle of
investors (cercle restreint dinvestisseurs) acting for
their own account, with qualified investors and
limited circle of investors having the meaning
ascribed to them in Article L.
411-2 of the
French Code Monétaire et Financier and applicable
regulations thereunder; none of this prospectus or any other
materials related to the offer or information contained therein
relating to our common stock has been released, issued or
distributed to the public in France except to Permitted
Investors; and the direct or indirect resale to the public in
France of any common stock acquired by any Permitted Investors
may be made only as provided by articles L.
412-1 and L.
621-8 of the
French Code Monétaire et Financier and applicable
regulations thereunder.
ITALY
The offering of shares of our common stock has not been cleared
by the Italian Securities Exchange Commission (Commissione
Nazionale per le Società e la Borsa, or the CONSOB)
pursuant to Italian securities legislation and, accordingly,
shares of our common stock may not and will not be offered, sold
or delivered, nor may or will copies of this prospectus or any
other documents relating to shares of our common stock or the
offering be distributed in Italy other than to professional
investors (operatori qualificati), as defined in
Article 31, paragraph 2 of CONSOB
Regulation No. 11522 of July 1, 1998, as amended,
or Regulation No. 11522.
Any offer, sale or delivery of shares of our common stock or
distribution of copies of this prospectus or any other document
relating to shares of our common stock or the offering in Italy
may and will be effected in accordance with all Italian
securities, tax, exchange control and other applicable laws and
regulations, and, in particular, will be: (i) made by an
investment firm, bank or financial intermediary permitted to
conduct such activities in Italy in accordance with the
Legislative Decree No. 385 of September 1, 1993, as
amended, or the Italian Banking Law, Legislative Decree
No. 58 of February 24, 1998, as amended,
Regulation No. 11522, and any other applicable laws
and regulations; (ii) in compliance with Article 129
of the Italian Banking Law and the implementing guidelines of
the Bank of Italy; and (iii) in compliance with any other
applicable notification requirement or limitation which may be
imposed by CONSOB or the Bank of Italy.
Any investor purchasing shares of our common stock in the
offering is solely responsible for ensuring that any offer or
resale of shares of common stock it purchased in the offering
occurs in compliance with applicable laws and regulations.
This prospectus and the information contained herein are
intended only for the use of its recipient and are not to be
distributed to any third party resident or located in Italy for
any reason. No person resident or located in Italy other than
the original recipients of this document may rely on it or its
content.
In addition to the above (which shall continue to apply to the
extent not inconsistent with the implementing measures of the
Prospective Directive in Italy), after the implementation of the
Prospectus Directive in Italy, the restrictions, warranties and
representations set out under the heading European
Economic Area above shall apply to Italy.
S-29
GERMANY
Shares of our common stock may not be offered or sold or
publicly promoted or advertised by any underwriter in the
Federal Republic of Germany other than in compliance with the
provisions of the German Securities Prospectus Act
(Wertpapierprospektgestz WpPG) of June 22,
2005, as amended, or of any other laws applicable in the Federal
Republic of Germany governing the issue, offering and sale of
securities.
SPAIN
Neither the common stock nor this prospectus have been approved
or registered in the administrative registries of the Spanish
National Securities Exchange Commission (Comisión Nacional
del Mercado de Valores). Accordingly, our common stock may not
be offered in Spain except in circumstances which do not
constitute a public offer of securities in Spain within the
meaning of articles 30bis of the Spanish Securities Markets
Law of 28 July 1988 (Ley 24/1988, de 28 de Julio, del
Mercado de Valores), as amended and restated, and supplemental
rules enacted thereunder.
SWEDEN
This is not a prospectus under, and has not been prepared in
accordance with the prospectus requirements provided for in, the
Swedish Financial Instruments Trading Act [lagen (1991:980) om
handel med finasiella instrument] nor any other Swedish
enactment. Neither the Swedish Financial Supervisory Authority
nor any other Swedish public body has examined, approved, or
registered this document.
SWITZERLAND
The common stock may not and will not be publicly offered,
distributed or re-distributed on a professional basis in or from
Switzerland and neither this prospectus nor any other
solicitation for investments in our common stock may be
communicated or distributed in Switzerland in any way that could
constitute a public offering within the meaning of
Articles 1156 or 652a of the Swiss Code of Obligations or
of Article 2 of the Federal Act on Investment Funds of
March 18, 1994. This prospectus may not be copied,
reproduced, distributed or passed on to others without the
underwriters prior written consent. This prospectus is not
a prospectus within the meaning of Articles 1156 and 652a
of the Swiss Code of Obligations or a listing prospectus
according to article 32 of the Listing Rules of the Swiss
Exchange and may not comply with the information standards
required thereunder. We will not apply for a listing of our
common stock on any Swiss stock exchange or other Swiss
regulated market and this prospectus may not comply with the
information required under the relevant listing rules. The
common stock offered hereby has not and will not be registered
with the Swiss Federal Banking Commission and has not and will
not be authorized under the Federal Act on Investment Funds of
March 18, 1994. The investor protection afforded to
acquirers of investment fund certificates by the Federal Act on
Investment Funds of March 18, 1994 does not extend to
acquirers of our common stock.
S-30
Legal matters
Goodwin Procter LLP of San Diego, California will issue an
opinion with respect to the validity of the issuance of the
securities being offered hereby. Dewey & Leboeuf LLP
of New York, New York is counsel to the underwriters in
connection with this offering.
Experts
Ernst & Young LLP, independent registered public
accounting firm, has audited our consolidated financial
statements included in our Annual Report on
Form 10-K
for the year ended December 31, 2007, and the effectiveness
of our internal control over financial reporting as of
December 31, 2007, as set forth in their reports, which are
incorporated by reference in this prospectus supplement and
elsewhere in the registration statement. Our financial
statements and our managements assessment of the
effectiveness of internal control over financial reporting as of
December 31, 2007 are incorporated by reference in reliance
on Ernst & Young LLPs reports, given on their
authority as experts in accounting and auditing.
Where you can find
more information and incorporation by reference
We file annual, quarterly and special reports, proxy statements
and other information with the Securities and Exchange
Commission, or the SEC. You may read and copy any document we
file at the SECs public reference room at
100 F Street, N.E., Washington, D.C., 20549. You
may also obtain copies from the SECs public reference room
by mail at prescribed rates. Please call the SEC at
1-800-SEC-0330
for further information about the operation of the public
reference room. Our SEC filings are also available to the public
from the SECs web site at www.sec.gov. Information about
La Jolla Pharmaceutical Company is also available to the
public from our website at www.ljpc.com. No portion of our
website is incorporated by reference into this prospectus.
The SEC allows us to incorporate by reference the
information that we file with it, which means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is
considered to be part of this prospectus supplement, and
information that we file later with the SEC will automatically
update and supersede information in this prospectus supplement.
We incorporate by reference the documents listed below and any
future filings we make with the SEC pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, as amended, until this offering is
completed:
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Our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2007;
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Our Current Reports on
Form 8-K
filed with the SEC on March 4, 2008, April 23, 2008
and May 2, 2008; and
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The description of our capital stock contained in our
Registration Statements on
Form 8-A,
filed on June 2, 1994 and on December 4, 1998, and the
post-effective amendments thereto, filed on January 26,
2001, December 16, 2005 and March 1, 2006.
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Each person to whom a copy of this prospectus supplement is
delivered may request a copy of any or all of the information
incorporated by reference in this prospectus supplement,
including the exhibits to
S-31
any filings incorporated by reference herein, at no cost by
writing or telephoning us at the following address or telephone
number:
Corporate
Secretary
La Jolla Pharmaceutical Company
6455 Nancy Ridge Drive
San Diego, California 92121
(858) 452-6600
You should rely only on the information contained in this
prospectus supplement and accompanying prospectuses. We have not
authorized anyone else to provide you with different
information. We are not making an offer of these securities in
any state where the offer is not permitted. You should not
assume that the information in this prospectus supplement is
accurate as of any date other than the date on the front of this
prospectus supplement.
Forward-looking
statements
We have made forward-looking statements in this prospectus
supplement that are based on our managements beliefs and
assumptions and on information currently available to our
management. Forward-looking statements include information
concerning our possible or assumed future results of operations
and statements preceded by, followed by, or that include the
words believes, expects,
anticipates, intends, plans,
estimates or similar expressions.
Forward-looking statements involve risks, uncertainties and
assumptions. Actual results may differ materially from those
expressed in these forward-looking statements. You are cautioned
not to put undue reliance on any forward-looking statements. The
forward-looking statements made in this prospectus supplement
and the accompanying prospectuses, as well as the information
that we have previously filed with the Securities and Exchange
Commission and incorporated by reference, is accurate only as of
the date of the applicable document. We undertake no obligation
to update any forward-looking statement to reflect events or
circumstances after the date on which the statement is made or
to reflect the occurrence of unanticipated events. These
forward-looking statements appear in a number of places in this
prospectus supplement and include statements regarding our
intentions, plans, strategies, beliefs or current expectations
and those of our directors or our officers. You should
understand that a number of factors could cause our results to
differ materially from those expressed in the forward-looking
statements. The information incorporated by reference or
provided in this prospectus supplement identifies important
factors that could cause such differences. Those factors
include, among others, the high cost and uncertainty of
technology and drug development, as well as regulatory
approvals, which can result in loss of profitability and long
delays in getting products to market, and other factors
discussed in Risk factors and elsewhere in this
prospectus supplement, the accompanying prospectuses and the
documents incorporated by reference.
S-32
PROSPECTUS
$125,000,000
La Jolla
Pharmaceutical Company
Common
Stock
This prospectus is a part of a registration statement that we
filed with the Securities and Exchange Commission utilizing a
shelf registration process. Under this shelf registration
process, we may sell our common stock described in this
prospectus in one or more offerings. Each time we sell
securities, we will provide specific terms of the offering in a
supplement to this prospectus. The prospectus supplement may
also add, update or change information contained in this
prospectus. You should read this prospectus and the applicable
prospectus supplement carefully before you invest in any of our
securities. This prospectus may not be used to consummate a sale
of securities unless accompanied by the applicable prospectus
supplement.
The aggregate public offering price of all securities sold under
this prospectus will not exceed $125,000,000.
Our common stock is traded on the Nasdaq National Market under
the symbol LJPC.
Investing in our
common stock involves a high degree of risk. See Risk
Factors beginning on page 2.
Neither the
Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus. Any
representation to the contrary is a criminal offense.
The date of this prospectus is December 12, 2002
No person is authorized to give any information or to make any
representations other than those contained or incorporated by
reference in this prospectus, and, if given or made, such
information or representations must not be relied upon as having
been authorized. This prospectus does not constitute an offer to
sell or the solicitation of an offer to buy any securities other
than the securities described in this prospectus or an offer to
sell or the solicitation of an offer to buy such securities in
any circumstances in which such offer or solicitation is
unlawful. Neither the delivery of this prospectus, nor any sale
made hereunder, shall, under any circumstances, create any
implication that there has been no change in our affairs since
the date hereof or that the information contained or
incorporated by reference herein is correct as of any time
subsequent to the date of such information.
TABLE OF
CONTENTS
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About this prospectus
This prospectus is part of a registration statement we filed
with the SEC pursuant to a shelf registration
process. Under this shelf registration process, we may sell the
securities described in this prospectus up to a total dollar
amount of $125,000,000. Each time we sell securities, we will
describe in a prospectus supplement, which we will deliver with
this prospectus, specific information about the offering. In
each prospectus supplement we will include the following
information:
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the amount of common stock which we propose to sell,
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the public offering price of the common stock,
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the names of the underwriters or agents, if any, through or to
which we will sell the common stock,
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any compensation of those underwriters or agents,
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information about any securities exchanges or automated
quotation systems on which the common stock will be listed or
traded, and
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any other material information about the offering and sale of
the common stock.
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In addition, the prospectus supplement may add, update or change
the information contained in this prospectus.
The Company
La Jolla Pharmaceutical Company is a biopharmaceutical
company focused on the research and development of highly
specific therapeutic products for the treatment of certain
life-threatening antibody-mediated diseases. These diseases,
including autoimmune conditions such as lupus erythematosus
(lupus) and antibody-mediated thrombosis, are caused
by abnormal B cell production of antibodies that attack healthy
tissues. Current treatments for these autoimmune disorders
address only symptoms of the disease, or nonspecifically
suppress the normal operation of the immune system, which often
results in severe, negative side effects and hospitalization. We
believe that our drug candidates, called
Toleragens®,
will treat the underlying cause of many antibody-mediated
diseases without these severe, negative side effects.
We are incorporated in the State of Delaware. Our principal
executive offices are located at 6455 Nancy Ridge Drive,
San Diego, California 92121 and our telephone number is
(858) 452-6600.
Recent developments
We completed enrollment in our Phase III clinical trial of
LJP 394 for the treatment of lupus renal disease on
November 11, 2002. Our study physicians are currently
conducting final patient visits, which we expect to be completed
in December 2002. After the completion of the patient visits,
our Phase III trial of LJP 394 will be finished and we will
collect and audit final data from the trial sites prior to
unblinding and analysis. We currently plan to report initial
results from the Phase III trial in early 2003, which could
be as early as February.
On October 27, 2002, we announced the preliminary results
from our first clinical trial evaluating our experimental drug
candidate, LJP 1082, for the treatment of antibody-mediated
stroke, heart attack, deep-vein thrombosis and recurrent
miscarriage. The Phase I/II trial was a randomized,
placebo-controlled study that was designed to evaluate the
safety and activity of a single dose of LJP 1082. Based on an
initial assessment of the trial data, the drug was well
tolerated at all five dose levels. Following treatment with a
single 50 or 200 mg dose, antibodies to LJP 1082 were
reduced in some patients. This study is the first of several
that may be required to establish, among other matters,
appropriate dose regimes.
1
Risk factors
An investment in our common stock involves a high degree of
risk. You should carefully consider the following risk factors
related to our common stock offered by this prospectus and to
our business and operations. You should also carefully consider
the other information in this prospectus and in the documents
incorporated by reference before you decide to purchase our
securities. Some of these factors have affected our financial
condition and operating results in the past or are currently
affecting us. All of these factors could affect our future
financial condition or operating results. If any of the
following risks actually occurs, our business could be harmed.
If that happens, the trading price of our common stock could
decline, and you may lose all or part of your investment.
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I.
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RISK FACTORS
RELATING TO LA JOLLA PHARMACEUTICAL AND THE INDUSTRY IN WHICH WE
OPERATE
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Our drug
candidates may not perform well in clinical trials. Without
successful clinical trials, we will not be able to market or
sell any products.
In order to sell our products that are under development, we
must first receive regulatory approval. To obtain regulatory
approval, we must conduct clinical trials and toxicology studies
that demonstrate that our products are safe and effective.
Although we believe LJP 394 and LJP 1082 are promising, they may
not be found to be safe or effective in ongoing or future
clinical trials and studies and results from previous trials and
studies may not be observed in current or future trials and
studies.
If LJP 394 and LJP 1082 are ultimately not found to be safe and
effective, we would be unable to obtain regulatory approval to
manufacture, market and sell these drugs. Because LJP 394 is our
only drug candidate that has advanced to Phase III clinical
trials, and because there is no guarantee that we would be able
to develop an alternate drug candidate, our inability to
commercialize LJP 394 would have a severe negative effect on our
business, and we may not have the financial resources to
continue research and development of LJP 394, LJP 1082 or any
other potential drug candidates.
Results from our
clinical trials may not be sufficient to obtain clearance to
market LJP 394 or our other drug candidates in the United States
or Europe on a timely basis, or at all.
Our drug candidates are subject to extensive government
regulations related to development, clinical trials,
manufacturing and commercialization. The process of obtaining
United States Food and Drug Administration and other regulatory
approvals is costly, time consuming, uncertain and subject to
unanticipated delays. The FDA and foreign regulatory authorities
have substantial discretion in the approval process. The FDA may
refuse to approve an application for approval of a drug
candidate if it believes that applicable regulatory criteria are
not satisfied. The FDA and foreign regulatory authorities may
not agree that we have demonstrated that LJP 394 or LJP 1082 are
safe and effective after we complete our clinical trials.
Even if the results of clinical trials are positive, the FDA and
foreign regulatory authorities may require us to design and
conduct additional studies to further demonstrate the safety and
efficacy of our drugs, which may result in significant expense
and delay. The FDA and foreign regulatory authorities may
require new or additional clinical trials because of
inconclusive results from earlier clinical trials, a possible
failure to conduct clinical trials in complete adherence to FDA
good clinical practice standards and similar standards of
foreign regulatory authorities, the identification of new
clinical trial endpoints, or the need for additional data
regarding the safety or efficacy of our drug candidates.
Moreover, if the FDA or foreign regulatory authorities grant
regulatory approval of a product, the approval may be limited to
specific indications or patient populations, or limited with
respect to its distribution. It is possible that the FDA or
foreign regulatory authorities may not ultimately approve LJP
394, LJP 1082 or our other drug candidates for commercial sale
in any jurisdiction, even if clinical results are positive. In
addition, even if a drug candidate is approved, it is possible
that a subsequent issue regarding its safety or efficacy would
require us to remove the drug from the market.
2
Because LJP 394 is our only drug candidate that has advanced to
Phase III clinical trials, and because there is no
guarantee that we would be able to develop an alternate drug
candidate, our inability to obtain regulatory approval of LJP
394 would have a severe negative effect on our business, and we
may not have the financial resources to continue research and
development of LJP 394, LJP 1082 or any other potential drug
candidates.
To obtain
regulatory approval of LJP 394, the FDA must approve our
manufacturing facilities and processes.
In addition to demonstrating the safety and efficacy of LJP 394,
we must obtain FDA approval of our manufacturing facilities in
order to obtain FDA approval for the commercial use of LJP 394.
As part of the approval process, we must also validate our
manufacturing facility and processes to the satisfaction of the
FDA. Although we have initiated the process of validating and
obtaining FDA approval for our facilities and processes, we have
never operated an FDA-approved manufacturing facility. If we are
unable to obtain the necessary approvals, the FDA will not
approve LJP 394 for commercial use.
Our blood test to
measure the binding affinity for LJP 394 has not been validated
by independent laboratories and will likely require regulatory
approval as part of the LJP 394 approval process.
In 1998, we developed a blood test that we believe can identify
the lupus patients who are most likely to respond to LJP 394.
The blood test is designed to measure the strength of the
binding between LJP 394 and a patients antibodies. This
affinity assay was used to identify the patients who will be
included in the efficacy analysis of the Phase III trial of
LJP 394. The assay has not been validated by independent
laboratories, and the results of the affinity assay observed in
our clinical trials of LJP 394 may not be observed in the
broader lupus patient population. In addition, regulatory
agencies will likely require that the assay be reviewed and
approved as part of the approval process of LJP 394.
Furthermore, the testing laboratory conducting the assay may
require additional regulatory approval. If additional regulatory
approval of the testing laboratory is required, the approval and
possible commercialization of LJP 394 may be delayed.
The technology
underlying our products is uncertain and unproven.
All of our product development efforts are based on unproven
technologies and therapeutic approaches that have not been
widely tested or used. To date, no products that use our
technology have been commercialized. LJP 394 and LJP 1082 have
not been proven to be safe and effective in humans, and the
technology on which they are based has been used only in our
pre-clinical tests and clinical trials. Application of our
technology to antibody-mediated diseases other than lupus and
antibody-mediated thrombosis is in earlier research stages.
Clinical trials of LJP 394 and LJP 1082 may be viewed as a
test of our entire approach to developing therapies for
antibody-mediated diseases. If LJP 394 or LJP 1082 does not work
as intended, or if the data from our clinical trials indicates
that LJP 394 or LJP 1082 is not safe and effective, the
applicability of our technology for treating antibody-mediated
diseases will be highly uncertain. As a result, there is a
significant risk that our therapeutic approaches will not prove
to be successful, and there can be no guarantee that our drug
discovery technologies will result in any commercially
successful products.
Future clinical
trials may be delayed or halted.
Future clinical trials of LJP 394 or LJP 1082, trials of drugs
related to these drugs, or clinical trials of other drug
candidates may be delayed or halted. During the development of
LJP 394, our Phase II/III clinical study, in collaboration with
Abbott Laboratories, was terminated before planned patient
enrollment was completed. Future trials may be delayed or halted
for various reasons, including:
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the products are not effective,
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patients experience severe side effects during treatment,
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patients do not enroll in the studies at the rate we expect, or
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supplies of drug product are not sufficient to treat the
patients in the studies.
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If any future trials are delayed or halted we may incur
significant additional expenses, which could have a severe
negative effect on our business.
We have a history
of losses and may not become profitable.
We have incurred operating losses each year since our inception
in 1989 and had an accumulated deficit of approximately
$140.4 million as of September 30, 2002. Our future
losses are likely to exceed those experienced in prior years due
to our continued clinical development of drug candidates,
increased manufacturing activities, which may include the
production of LJP 394 for an open-label follow-on study and the
production of LJP 1082 for clinical and toxicology studies, and
continued research and development efforts. In addition,
assuming we receive favorable clinical results and FDA approval
for LJP 394, we will be required to develop commercial
manufacturing capabilities and sales and marketing programs. To
achieve profitability we must, among other matters, complete the
development of our products, obtain all necessary regulatory
approvals and establish commercial manufacturing, marketing and
sales capabilities. We expect to incur significant losses each
year for at least the next several years as our clinical trial,
research, development, manufacturing, marketing and sales
activities increase. The amount of losses and the time required
by us to reach sustained profitability are highly uncertain and
we may never achieve profitability. We do not expect to generate
revenues from the sale of LJP 394, if approved, until at least
2004, or our other products, if any, for several years, and we
may never generate product revenues.
We will need
additional funds to support our operations and may need to
reduce operations, sell stock or assets, enter into
collaborative agreements or merge with another entity to
continue operations.
Our operations to date have consumed substantial capital
resources, and we will continue to expend substantial and
increasing amounts of capital for research, product development,
pre-clinical testing and clinical trials of drug candidates.
Assuming that we receive favorable clinical results and
regulatory approval for our drug candidates, we may also devote
substantial capital resources to establish commercial-scale
manufacturing capabilities and to market and sell potential
products. We will need to raise additional funds to finance our
future operations. Our future capital requirements will depend
on many factors, including:
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continued scientific progress in our research and development
programs,
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the size and complexity of our research and development programs,
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the scope and results of pre-clinical testing and clinical
trials,
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the time and costs involved in applying for regulatory approvals,
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the costs involved in preparing, filing, prosecuting,
maintaining and enforcing patent claims,
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competing technological and market developments,
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our ability to establish and maintain collaborative research and
development arrangements,
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our need to establish commercial manufacturing capabilities, and
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our ability to develop marketing and sales programs.
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We expect to incur substantial and increasing losses each year
for at least the next several years as our clinical trial,
research, development and manufacturing activities increase. If
we receive regulatory approval for LJP 394, LJP 1082 or our
other drug candidates, our manufacturing, marketing and sales
activities are likely to substantially increase our expenses and
our need for working capital. We anticipate that our existing
cash, investments and interest earned thereon will be sufficient
to fund our operations as currently planned into the fourth
quarter of 2003, assuming that we do not undertake significant
commercialization activities for LJP 394 such as building
inventory for launch or hiring a
4
sales force. However, the amounts expended by us may vary
significantly, and it is possible that our cash requirements
will exceed current projections and that we will therefore need
additional financing sooner than currently expected. In the
future, it is possible that we will not have adequate resources
to support our business activities.
We actively seek additional funding, including through public
and private financings and collaborative arrangements. Our
choice of financing alternatives may vary from time to time
depending on various factors, including the market price of our
securities, conditions in the financial markets and the interest
of other entities in strategic transactions with us. There can
be no guarantee that additional financing will be available on
favorable terms, if at all, whether through issuance of
securities, collaborative arrangement, or otherwise. If adequate
funds are not available, we may be required to delay, scale back
or eliminate one or more of our research and development
programs or obtain funds through arrangements with collaborative
partners or others that require us to relinquish rights to
certain technologies or potential products. We also may be
required to merge with another entity to continue our
operations. Any one of these outcomes could have a negative
impact on our ability to develop products or achieve
profitability if our products are brought to market. If, and to
the extent, we obtain additional funding through sales of
securities, your investment in us will be diluted.
The size of the
market for our potential products is uncertain.
We estimate that the number of people who suffer from lupus in
the United States and Europe is approximately 1,000,000 and that
those with renal impairment, which LJP 394 is designed to treat,
is approximately 300,000. With respect to antibody-mediated
thrombosis, which LJP 1082 is designed to treat, we estimate
that there are approximately 1,000,000 to
2,000,000 patients in the United States and Europe.
However, there is limited information available regarding the
actual size of these patient populations. In addition, it is
uncertain whether the results from previous or current clinical
trials of our drug candidates will be observed in broader
patient populations, and the number of patients who may benefit
from our drug candidates may be significantly smaller than the
estimated patient populations. Furthermore, management of
patients with renal disease by specialists other than
nephrologists and immunologists is likely to reduce our ability
to access patients who may benefit from LJP 394.
Our drugs may not
achieve market acceptance.
Even if our drug treatment for lupus, LJP 394, or our other
drugs candidates receive regulatory approval, patients and
physicians may not readily accept our proposed methods of
treatment. In order for LJP 394 or our other drug candidates to
be commercially successful, we will need to increase the
awareness and acceptance of our drugs among physicians, patients
and the medical community. LJP 394 is designed to be
administered intravenously. It is possible that providers and
patients may resist an intravenously administered therapeutic.
In addition, if we are unable to manufacture drugs at an
acceptable cost, physicians may not readily prescribe our drugs
due to cost-benefit considerations when compared to other
methods of treatment. If we are unable to achieve market
acceptance for our approved products, our revenues and
profitability will be negatively affected.
We lack
experience in marketing products for commercial sale.
In order to commercialize any drug candidate approved by the
FDA, we must either develop marketing and sales programs or
enter into marketing arrangements with others. If we cannot do
either of these successfully, we will not generate meaningful
sales of our products. If we develop our own marketing and sales
capabilities, we will be required to employ a sales force,
establish and staff a customer service department, and create or
identify distribution channels for our drugs. We will compete
with other companies that have experienced and well-funded
marketing and sales operations. In addition, if we establish our
own sales and distribution capabilities, we may experience
delays and expenditures and have difficulty in gaining market
acceptance for our drug candidates. We currently have no
marketing arrangements with others. There can be no guarantee
that, if we desire to, we will be able to enter into
5
any marketing agreements on favorable terms, if at all, or that
any such agreements will result in payments to us. If we enter
into co-promotion or other marketing and sales arrangements with
other companies, any revenues that we may receive will be
dependent on the efforts of others. There can be no guarantee
that these efforts will be successful.
Our limited
manufacturing capabilities and experience could result in
shortages of products for testing and future sale, and our
revenues and profit margin could be negatively
affected.
Substantial capital investment in the expansion and build-out of
our manufacturing facilities will be required to enable us to
manufacture LJP 394 in significant commercial quantities. We
have limited manufacturing experience, and we may be unable to
successfully transition to commercial production. In addition,
we have never operated an FDA-approved manufacturing facility,
and we will be required to manufacture LJP 394 pursuant to
applicable FDA good manufacturing practices. Our inexperience
could result in manufacturing delays or interruptions and higher
manufacturing costs. This could negatively affect our ability to
introduce products into the market on a timely and competitive
basis. In addition, the subsequent sales of our products and our
profit margins may be negatively affected.
We may enter into arrangements with contract manufacturing
companies to expand our own production capacity in order to meet
demand for our products, or to attempt to improve manufacturing
efficiency. If we choose to contract for manufacturing services
and encounter delays or difficulties in establishing
relationships with manufacturers to produce, package or
distribute our finished products, or the contract manufacturers
are unable to meet our needs, the introduction of our products
into the market and the subsequent sales of these products would
be negatively affected, and our profit margins and our ability
to develop and deliver products on a timely and competitive
basis may be negatively affected.
Our suppliers may
not be able to provide us with sufficient quantities of
materials that we may need to manufacture our
products.
We rely on outside suppliers to provide us with specialized
chemicals and reagents that we use to manufacture our drugs. In
order to manufacture LJP 394, LJP 1082 and our other drug
candidates in sufficient quantities for our clinical trials and
possible commercialization, our suppliers will be required to
provide us with an adequate supply of chemicals and reagents.
Our ability to obtain these chemicals and reagents is subject to
the following risks:
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our suppliers may not be able to increase their own
manufacturing capabilities in order to provide us with a
sufficient amount of material for our use,
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some of our suppliers may be required to obtain FDA or other
regulatory approvals of their manufacturing facilities or
processes, and they may be delayed or unable to do so,
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the materials that our suppliers use to manufacture the
chemicals and reagents which they provide us may be costly or in
short supply, and
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there may be a limited number of suppliers which are able to
provide us with the chemicals or reagents that we use to
manufacture our drugs.
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If we are unable to obtain sufficient quantities of chemicals or
reagents, the introduction of our products into the market and
the subsequent sales of these products would be negatively
affected, and our profit margins and our ability to develop and
deliver products on a timely and competitive basis may be
negatively affected.
We may not earn
as much income as we hope due to possible changes in healthcare
reimbursement policies.
The continuing efforts of government and healthcare insurance
companies to reduce the costs of healthcare may reduce the
amount of income we can generate from our products. For example,
in certain foreign markets, pricing and profitability of
prescription drugs are subject to government
6
control. In the United States, we expect that there will
continue to be a number of federal and state proposals to
implement similar government controls. In addition, increasing
emphasis on managed care in the United States will continue to
put pressure on drug manufacturers to reduce prices. Cost
control initiatives could reduce the revenue that we receive for
any products we may develop and sell in the future.
Our success in
developing and marketing our products depends significantly on
our ability to obtain patent protection for LJP 394, LJP 1082
and any other developed products. In addition, we will need to
successfully preserve our trade secrets and operate without
infringing on the rights of others.
We depend on patents and other unpatented intellectual property
to prevent others from improperly benefiting from products or
technologies that we may have developed. As of December 31,
2001, we owned 96 issued patents and 82 pending patent
applications covering various technologies and drug candidates
including LJP 394 and LJP 1082. However, there can be no
assurance that any additional patents will be issued, that the
scope of any patent protection will be sufficient, or that any
current or future issued patent will be held valid if
subsequently challenged. There is a substantial backlog of
biotechnology patent applications at the United States Patent
and Trademark Office that may delay the review and issuance of
any patents. The patent position of biotechnology firms like
ours is highly uncertain and involves complex legal and factual
questions, and no consistent policy has emerged regarding the
breadth of claims covered in biotechnology patents or the
protection afforded by these patents. Currently, we have a
number of patent applications pending in the United States
relating to our technology, as well as foreign counterparts to
some of our United States patent applications. We intend to
continue to file applications as believed appropriate for
patents covering both our products and processes. There can be
no assurance that patents will be issued from any of these
applications, or that the scope of any issued patents will
protect our technology.
We do not necessarily know if others, including competitors,
have patents or patent applications pending that relate to
compounds or processes that overlap or compete with our
intellectual property. We are aware of one United States patent
grant that contains claims covering subject matter that may
conflict with some of our key patents and patent applications,
and that may affect our ability to manufacture and sell our
products. If the United States Patent and Trademark Office or
any foreign counterpart issues or has issued patents containing
competitive or conflicting claims, and if these claims are
valid, the protection provided by our existing patents or any
future patents that may be issued could be significantly
reduced, and our ability to prevent competitors from developing
products or technologies identical or similar to ours could be
negatively affected. In addition, there can be no guarantee that
we would be able to obtain licenses to these patents on
commercially reasonable terms, if at all, or that we would be
able to develop or obtain alternative technology. Our failure to
obtain a license to a technology or process that may be required
to develop or commercialize one or more of our product
candidates may have a material adverse effect on our business.
In addition, we may have to incur significant expenses in
defending or enforcing our patents.
We also rely on unpatented intellectual property such as trade
secrets and improvements, know-how, and continuing technological
innovation. While we seek to protect these rights, it is
possible that:
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inventions relevant to our business will be developed by others,
including competitors,
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our binding confidentiality agreements will be breached, and we
will not have adequate remedies for such a breach, or
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our trade secrets will otherwise become known or be
independently discovered by competitors.
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We could incur substantial costs in defending suits brought
against us by others for infringement of intellectual property
rights or in prosecuting suits that we might bring against
others to protect our intellectual property rights.
7
Our research and
development and operations depend in part on certain key
employees. Losing these employees would have a negative effect
on our product development and operations.
We are highly dependent on the principal members of our
scientific and management staff, the loss of whose services
would delay the achievement of our research and development
objectives. This is because our key personnel, including Steven
Engle, Dr. Matthew Linnik, Dr. Paul Jenn and
Dr. Andrew Wiseman, have been involved in the development
of LJP 394, LJP 1082 and other drug candidates for several years
and have unique knowledge of our drug candidates and of the
technology on which they are based. In addition, we will be
required to rely on key members of our senior management team,
including Bruce Bennett, William Welch, Karen Church, and
Dr. Kenneth Heilbrunn, to assist us with our anticipated
growth and expansion into areas requiring additional expertise,
such as clinical trials, regulatory approvals, manufacturing,
marketing and sales. We expect that we will continue to require
additional management personnel, and that our existing
management personnel will be required to develop additional
expertise.
Retaining our
current personnel and recruiting additional personnel will be
critical to our success.
Retaining our current key personnel and recruiting additional
qualified personnel to perform research and development,
clinical development, manufacturing, marketing and sales will be
critical to our success. Because competition for experienced
scientific, clinical, sales, manufacturing, marketing and sales
personnel among numerous pharmaceutical and biotechnology
companies and research and academic institutions is intense, we
may not be able to attract and retain these people. If we cannot
attract and retain qualified people, our ability to conduct
necessary clinical trials and to develop and sell our products
may be negatively affected because, for instance, the trials may
not be conducted properly, or the manufacturing or sales of our
products may be delayed. In addition, we rely upon consultants
and advisors to assist us in formulating our research and
development, clinical, regulatory, manufacturing, marketing and
sales strategies. All of our consultants and advisors have
outside employment and may have commitments or consulting or
advisory contracts with other entities that may affect their
ability to contribute to our business.
Our freedom to
operate our business or profit fully from sales of our products
may be limited if we enter into collaborative
agreements.
We may seek to collaborate with pharmaceutical companies to gain
access to their research, drug development, manufacturing,
marketing, sales and financial resources. However, we may not be
able to negotiate arrangements with any collaborative partners
on favorable terms, if at all. Any collaborative relationships
that we enter into may include restrictions on our freedom to
operate our business or may limit the sales of our products. If
a collaborative arrangement is established, the collaborative
partner may discontinue funding any particular program or may,
either alone or with others, pursue alternative technologies or
develop alternative drug candidates for the diseases we are
targeting. Competing products, developed by a collaborative
partner or to which a collaborative partner has rights, may
result in the collaborative partner withdrawing support as to
all or a portion of our technology.
Without collaborative arrangements, we must fund our own
research, development, manufacturing, marketing and sales
activities which would accelerate the depletion of our cash and
require us to develop our own manufacturing, marketing and sales
capabilities. Therefore, if we are unable to establish and
maintain collaborative arrangements and if other sources of cash
are not available, we could experience a material adverse effect
on our ability to develop products and, if developed, to
manufacture, market and sell them successfully.
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Because a number
of companies compete with us, many of which have greater
resources than we do, and because we face rapid changes in
technology in our industry, we cannot be certain that our
products will be accepted in the marketplace or capture market
share.
Competition from domestic and foreign biotechnology companies,
large pharmaceutical companies and other institutions is intense
and is expected to increase. A number of companies and
institutions are pursuing the development of pharmaceuticals in
our targeted areas, many of which are very large, and have
financial, technical, sales and distribution and other resources
substantially greater than ours. The greater resources of these
competitors could enable them to develop competing products more
quickly than we are able to, and to market any competing product
more quickly or effectively so as to make it extremely difficult
for us to develop a share of the market for our products. These
competitors also include companies that are conducting clinical
trials and pre-clinical studies for the treatment of lupus and
thrombosis. Our competitors may develop or obtain regulatory
approval for products more rapidly than we do. Also, the
biotechnology and pharmaceutical industries are subject to rapid
changes in technology. Our competitors may develop and market
technologies and products that are more effective or less costly
than those being developed by us, or that would render our
technology and proposed products obsolete or noncompetitive.
An interruption
in the operation of our sole manufacturing facility could
disrupt our operations.
We have only one drug manufacturing facility. A significant
interruption in the operation of this facility, whether as a
result of a natural disaster or other causes, could
significantly impair our ability to manufacture drugs for our
clinical trials or possible commercialization.
The use of LJP
394, LJP 1082 and other potential products in clinical trials,
as well as the sale of any approved products, may expose us to
lawsuits resulting from the use of these products.
The use and possible sale of LJP 394, LJP 1082 and other
potential products may expose us to legal liability and generate
negative publicity if we are subject to claims that people were
harmed by our products. These claims might be made directly by
patients, pharmaceutical companies, or others. We currently
maintain $10.0 million of product liability insurance for
claims arising from the use of our products in clinical trials.
However, coverage is becoming increasingly expensive, and there
can be no guarantee that we will be able to maintain insurance
or that insurance can be acquired at a reasonable cost or in
sufficient amounts to protect us against possible losses.
Furthermore, it is possible that our financial resources would
be insufficient to satisfy potential product liability claims. A
successful product liability claim or series of claims brought
against us could negatively impact our business and financial
condition.
We face
environmental liabilities related to certain hazardous materials
used in our operations.
Due to the nature of our manufacturing processes, we are subject
to stringent federal, state and local laws governing the use,
handling and disposal of certain materials and wastes. We may
have to incur significant costs to comply with environmental
regulations if and when our manufacturing increases to
commercial volumes. Our operations may be significantly affected
by current or future environmental laws because, for instance,
our production process may be required to be altered, thereby
increasing our production costs. In our research activities, we
use radioactive and other materials that could be hazardous to
human health, safety or the environment. These materials and
various wastes resulting from their use are stored at our
facility pending ultimate use and disposal. The risk of
accidental injury or contamination from these materials cannot
be eliminated. In the event of such an accident, we could be
held liable for any resulting damages, and any such liability
could exceed our resources. Although we maintain general
liability insurance, we do not specifically insure against
environmental liabilities.
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RISK FACTORS
RELATED SPECIFICALLY TO OUR STOCK
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Our common stock
price is volatile and may decline even if our business is doing
well.
The market price of our common stock has been and is likely to
continue to be highly volatile. Market prices for securities of
biotechnology and pharmaceutical companies, including ours, have
historically been highly volatile, and the market has from time
to time experienced significant price and volume fluctuations
that are unrelated to the operating performance of particular
companies. The following factors, among others, can have a
significant effect on the market price of our securities:
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our clinical trial results,
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announcements of technological innovations or new therapeutic
products by us or others,
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developments in patent or other proprietary rights,
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public concern as to the safety of drugs discovered or developed
by us or others,
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future sales of significant amounts of our common stock by
existing stockholders,
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developments concerning potential agreements with collaborators,
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comments by securities analysts and general market conditions,
and
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government regulation.
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The realization of any of the risks described in these
Risk Factors could have a negative effect on the
market price of our common stock.
In the future,
our stock may be removed from listing on the Nasdaq quotation
system and may not qualify for listing on any stock exchange, in
which case it may be difficult to find a market in our
stock.
If our stock is no longer traded on a national trading market,
it may be more difficult for you to sell shares that you own,
and the price of the stock may be negatively affected.
Currently, our securities are traded on the Nasdaq National
Market. Nasdaq has several continued listing requirements,
including a minimum trading price. Previously, we have received
notice from Nasdaq that our stock price fell below this minimum
trading price. Although we have since come back into compliance
with this Nasdaq requirement, it is possible that we will fall
out of compliance with this
and/or other
Nasdaq continued listing criteria at some point in the future.
Failure to comply with any one of several Nasdaq requirements
may cause our stock to be removed from listing on Nasdaq. Should
this happen, we may not be able to secure listing on other
exchanges or quotation systems. This would have a negative
effect on the price and liquidity of our stock.
Future sales of
our stock by existing stockholders could negatively affect the
market price of our stock and make it more difficult for us to
sell stock in the future.
Sales of our common stock in the public market, or the
perception that such sales could occur, could result in a drop
in the market price of our securities and make it more difficult
for us to complete future equity financings on acceptable terms,
if at all. We have outstanding the following shares of common
stock:
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Approximately 42,354,328 shares of common stock that have
been issued in registered offerings or are otherwise freely
tradable in the public markets.
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Approximately 72,473 shares of common stock currently
eligible for resale in the public market pursuant to SEC
Rule 144.
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As of November 20, 2002, there are an aggregate of
5,673,355 shares of common stock that may be issued on the
exercise of outstanding stock options granted under our various
stock option plans at a weighted average exercise price of $4.82
per share.
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We have in effect registration statements under the Securities
Act registering approximately 8,100,000 shares of common
stock reserved under our incentive stock option and employee
stock
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purchase plans. Approximately 147,600 shares of common
stock that may be issued on the exercise of outstanding stock
options will be available for public resale under SEC
Rule 144 pursuant to Rule 701 under the Securities Act.
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Pursuant to the registration statement of which this prospectus
forms a part, we may issue up to $125,000,000 aggregate amount
of common stock.
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We cannot estimate the number of shares of common stock that may
actually be resold in the public market because this will depend
on the market price for our common stock, the individual
circumstances of the sellers and other factors. We also have a
number of institutional stockholders that own significant blocks
of our common stock. If these stockholders sell significant
portions of their holdings in a relatively short time, for
liquidity or other reasons, the market price of our common stock
could drop significantly.
Anti-takeover
devices may prevent changes in our management.
We have in place several anti-takeover devices, including a
stockholder rights plan, that may have the effect of delaying or
preventing changes in our management. For example, one
anti-takeover device provides for a board of directors that is
separated into three classes, with their terms in office
staggered over three year periods. This has the effect of
delaying a change in control of our board of directors without
the cooperation of the incumbent board. In addition, our bylaws
require stockholders to give us written notice of any proposal
or director nomination within a specified period of time prior
to the annual stockholder meeting, establish certain
qualifications for a person to be elected or appointed to the
board of directors during the pendency of certain business
combination transactions, and do not allow stockholders to call
a special meeting of stockholders.
We may also issue shares of preferred stock without further
stockholder approval and upon terms that our board of directors
may determine in the future. The issuance of preferred stock
could have the effect of making it more difficult for a third
party to acquire a majority of our outstanding stock, and the
holders of such preferred stock could have voting, dividend,
liquidation and other rights superior to those of holders of our
common stock.
We do not pay
dividends and this may negatively affect the price of our
stock.
We have not paid any cash dividends since our inception and do
not anticipate paying any cash dividends in the foreseeable
future. The future price of our common stock may be depressed by
the fact that we have not paid dividends.
Description of
capital stock
The following description of our capital stock sets forth
general terms and provisions of our common stock to which a
prospectus supplement may relate. The following summary of our
amended and restated certificate of incorporation and amended
and restated bylaws does not describe the certificate and bylaws
entirely. We urge you to read our certificate and bylaws which
are incorporated by reference as exhibits to the registration
statement of which this prospectus is a part. See Where
You Can Find More Information on page 18. On the date
of this prospectus, our authorized capital stock consists of
100,000,000 shares of common stock, $0.01 par value
per share, and 8,000,000 shares of preferred stock,
$0.01 par value per share.
COMMON
STOCK
Voting Rights. Holders of our common stock are
entitled to one vote per share on all matters to be voted upon
by our stockholders. The vote of the holders of a majority of
the stock represented at a meeting at which a quorum is present
is generally required to take stockholder action, unless a
greater vote is required by law or specifically required by our
certificate of incorporation or bylaws. Special stockholder
meetings may be called only by the board of directors, the
chairman of the board or the
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president. Our certificate provides that our stockholders may
not act by written consent. In addition, our bylaws include an
advance notice procedure with regard to the nomination, other
than by or at the direction of the board of directors, of
candidates for election as directors and with regard to matters
to be brought before an annual meeting or special meeting of
stockholders.
Dividends and Other Rights. Holders of our common
stock are entitled to receive, as when and if declared by the
board of directors from time to time, such dividends and other
distributions in cash, stock or property from our assets or
funds legally available for such purposes subject to any
dividend preferences that may be attributable to preferred stock
that may be authorized. In the event of our liquidation,
dissolution or winding up, after all liabilities and the holders
of each series of preferred stock, if any, have been paid in
full, the holders of our common stock are entitled to share
ratably in all remaining assets available for distribution. Our
common stock has no preemptive, subscription, redemption or
conversion rights. There are no sinking fund provisions
applicable to our common stock.
Classified Board of Directors. Our certificate of
incorporation and bylaws provide for a classified board of
directors. Our board is classified into three classes, each as
nearly equal in number as possible. At each annual meeting, the
successors to the class of directors whose term expire at that
meeting are elected for a term of office to expire at the third
succeeding annual meeting after their election or until their
successors have been duly elected and qualified. Delaware law
provides that, unless the certificate of incorporation provides
otherwise, directors serving on a classified board of directors
may be removed only for cause. Our certificate of incorporation
does not provide otherwise. Therefore, our directors may only be
removed for cause. The affirmative vote of the holders of 75% or
more of the total voting power of all outstanding shares of
voting stock would be required to amend our certificate or
bylaws to remove the classified board provisions.
Rights Plan. Each outstanding share of our common
stock is accompanied by a right to purchase our preferred stock,
our common stock or the common stock of a successor company
pursuant to the terms of a rights agreement. Please refer to the
discussion entitled La Jolla Pharmaceutical Company
Rights Plan below.
Delaware Takeover Statute. We are subject to the
provisions of Section 203 of the Delaware General
Corporation Law. In general, the statute prohibits a publicly
held Delaware corporation from engaging in a business
combination with an interested stockholder for a period of three
years after the date of the transaction in which the person
became an interested stockholder, unless the business
combination is approved in a prescribed manner. For purposes of
Section 203, a business combination includes a merger,
asset sale or other transaction resulting in a financial benefit
to the interested stockholder. An interested stockholder is a
person who, together with affiliates and associates, owns (or
within three years prior, did own) 15% or more of the
corporations voting stock. Delaware law, the existence of
our Rights Agreement, and the provisions of our certificate and
bylaws may have the effect of deterring hostile takeovers or
delaying changes in control of our management, which could
depress the market price of our common stock.
Transfer Agent. American Stock Transfer &
Trust Company is the Transfer Agent and Registrar for the
shares of our common stock.
PREFERRED
STOCK
Our board of directors has the authority, without further action
by stockholders, to issue up to 8,000,000 shares of
preferred stock in one or more series and to fix the powers,
designations, rights, preferences, privileges, qualifications,
and restrictions thereof, including dividend rights, conversion
rights, voting rights, rights and terms of redemption,
liquidation preferences and sinking fund terms, any or all of
which may be greater than the rights of our common stock. Our
board of directors, without further stockholder approval, can
issue preferred stock with voting, conversion, and other rights
that could adversely affect the voting power and other rights of
the holders of common stock. The issuance of preferred stock in
certain circumstances may have the effect of delaying, deferring
or preventing a change in control of La Jolla
Pharmaceutical, may discourage bids for our common stock
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at a premium over the market price of the common stock, and may
adversely affect the market price of our common stock. As of the
date of this prospectus, there are no shares of our preferred
stock outstanding.
We have filed a certificate of designation with the Secretary of
State of the State of Delaware which designates
100,000 shares of preferred stock as Series A Junior
Participating Preferred Stock in connection with our stockholder
rights plan, as described below. We refer to our Series A
Junior Participating Preferred Stock as our Series A
Preferred Shares. Except to the extent that a right to purchase
our Series A Preferred Shares accompanies each share of our
common stock, no shares of our preferred stock are covered by
this prospectus.
LA JOLLA
PHARMACEUTICAL COMPANY RIGHTS PLAN
On November 19, 1998, our board of directors authorized and
declared a dividend of one right for each share of our common
stock. On December 3, 1998, we entered into a Rights
Agreement with American Stock Transfer &
Trust Company, as Rights Agent, and filed a Certificate of
Designation with the State of Delaware regarding our
Series A Preferred Shares. The Company paid the rights
dividend to the holders of record of common stock as of the
close of business on December 18, 1998. Common stock
certificates issued after December 18, 1998, and prior to
the Distribution Date (as defined in the Rights Agreement),
contain a notation incorporating the Rights Agreement by
reference. Currently, there are no separate rights certificates.
Each right is attached to each share of our common stock and
trades automatically with the common stock. Rights will not be
separable from common stock or exercisable, unless specified
events described in the Rights Agreement occur. Upon the
occurrence of the events described in the Rights Agreement, the
rights will separate from the common stock and may thereafter
become exercisable to purchase additional securities. The Rights
Agreement, as amended, can be found in the documents that are
incorporated by reference as exhibits to the registration
statement of which this prospectus is a part. See Where
You Can Find More Information on page 13.
Use of proceeds
We intend to use the net proceeds we receive from the sale of
the securities offered by this prospectus to fund the continued
research and development of our potential products, including
the funding of our current and future trials of LJP 394 and LJP
1082 and any related regulatory submissions, to expand and
validate our existing facilities, processes and infrastructures,
for other general corporate purposes, or for any other purposes
that may be described in an accompanying prospectus supplement.
We will retain broad discretion over the use of the net proceeds
from any sale of our common stock offered hereby. The amounts
and timing of expenditures may vary significantly depending on
several factors, including the progress of our research and
development efforts, the results of our clinical trials, the
time and costs of obtaining regulatory approvals, our future
capital expenditures, our need to develop commercial marketing
and sales capabilities, and our ability to generate revenues in
the future.
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Plan of distribution
The securities that may be offered pursuant to this prospectus
and any prospectus supplement may be offered by us to one or
more underwriters for public offering and sale by them, to
investors directly (through a specific bidding or auction
process, or otherwise) or through agents. Any such underwriter
or agent involved in the offer and sale of such securities will
be named in the applicable prospectus supplement. Sales of such
securities may be effected from time to time in one or more
types of transactions, which may include block transactions, on
the Nasdaq National Market or other securities exchange, in the
over-the-counter market, in negotiated transactions, through put
or call options transactions relating to the securities, through
short sales of the securities, or a combination of such methods
of sale. Such transactions may or may not involve brokers or
dealers.
Underwriters may offer and sell the securities at a fixed price
or prices, which may be changed, at market prices prevailing at
the time of sale, at prices related to such prevailing market
prices or at negotiated prices. The consideration may be cash or
another form negotiated by the parties.
In connection with the sale of the securities, underwriters may
receive compensation from us in the form of underwriting
discounts, concessions or commissions and may also receive
commissions from purchasers of the securities for whom they may
act as agent. Underwriters may sell the securities to or through
dealers who may receive compensation from the underwriters in
the form of discounts, concessions or commissions or commissions
from the purchasers for whom they may act as agents.
Direct sales of securities may be made on a national securities
exchange or otherwise.
Dealers and agents participating in the distribution of the
securities may be deemed to be underwriters, and any discounts
and commissions received by them and any profit realized by them
on resale of the securities may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933, as
amended. Underwriters, dealers, agents and remarketing firms
described below may be entitled, under agreements entered into
with us, to indemnification against and contribution toward
certain civil liabilities, including liabilities under the
Securities Act of 1933, as amended.
Certain of the underwriters, dealers, agents and remarketing
firms and their associates may engage in transactions with, and
perform services for, us in the ordinary course of business.
We may directly solicit offers to purchase the securities and we
may make sales of securities directly to institutional investors
or others. These persons may be deemed to be underwriters within
the meaning of the Securities Act of 1933, as amended, with
respect to any resales of the securities. To the extent
required, the prospectus supplement will describe the terms of
any such sales, include the terms of any bidding or auction
process, if used.
Under the securities laws of some states, the securities offered
by the prospectus may be sold in those states only through
registered or licensed brokers or dealers.
It is possible that one or more underwriters may make a market
in our common stock, but the underwriters will not be obligated
to do so and may discontinue any market making at any time
without notice. We cannot give any assurance as to the liquidity
of the trading market for our common stock.
Offered securities may also be offered and sold, if so indicated
in the applicable prospectus supplement, in connection with a
remarketing upon their purchase, in accordance with a redemption
or repayment pursuant to their terms, or otherwise, by one or
more remarketing firms acting as principals for their own
accounts or as agents for us. Any remarketing firm will be
identified and the terms of its agreements, if any, with us and
its compensation will be described in the applicable prospectus
supplement. Remarketing firms may be deemed to be underwriters,
as that term is defined in the Securities Act of 1933, as
amended, in connection with the securities marketed by them.
If we so indicate in the prospectus supplement, we may authorize
agents, underwriters or dealers to solicit offers from certain
purchasers to purchase securities from us at the public offering
price set forth in the applicable prospectus supplement pursuant
to delayed delivery contracts providing for payment
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and delivery on a specified date in the future. The contracts
would be subject only to those conditions described in the
applicable prospectus supplement. The applicable prospectus
supplement will describe the commission payable for solicitation
of those contracts.
Certain persons participating in the offering may engage in
over-allotment, stabilizing transactions, short-covering
transactions and penalty bids in accordance with
Regulation M under the Securities Exchange Act of 1934, as
amended. Over-allotment involves sales in excess of the offering
size, which create a short position. Stabilizing transactions
permit bids to purchase the underlying security so long as the
stabilizing bids do not exceed a specified maximum.
Short-covering transactions involve purchases of the securities
in the open market after the distribution is completed to cover
short positions. Penalty bids permit the underwriters to reclaim
a selling concession from a dealer when the securities
originally sold by the dealer are purchased in a covering
transaction to cover short positions. Those activities may cause
the price of the securities to be higher than it would otherwise
be. The persons engaging in these activities may discontinue any
of these activities at any time.
Legal
matters
Gibson, Dunn & Crutcher LLP has rendered an opinion
with respect to the validity of the securities being offered by
this prospectus. If counsel for any underwriters passes on legal
matters in connection with an offering of the securities
described in this prospectus, we will name that counsel in the
prospectus supplement relating to that offering.
Experts
Ernst & Young LLP, independent auditors, have audited
our financial statements included in our Annual Report on
Form 10-K
for the year ended December 31, 2001, as set forth in their
report, which is incorporated by reference in this prospectus
and elsewhere in the registration statement. Our financial
statements are incorporated by reference in reliance on
Ernst & Young LLPs report, given on their
authority as experts in accounting and auditing.
Forward-looking
statements
We have made forward-looking statements in this prospectus that
are based on our managements beliefs and assumptions and
on information currently available to our management.
Forward-looking statements include information concerning our
possible or assumed future results of operations and statements
preceded by, followed by, or that include the words
believes, expects,
anticipates, intends, plans,
estimates or similar expressions.
Forward-looking statements involve risks, uncertainties and
assumptions. Actual results may differ materially from those
expressed in these forward-looking statements. You are cautioned
not to put undue reliance on any forward-looking statements.
Except as may be required by law, we do not have any intention
or obligation to update forward-looking statements after we
distribute this prospectus. These statements appear in a number
of places in this prospectus and include statements regarding
our intentions, plans, strategies, beliefs or current
expectations and those of our directors or our officers with
respect to, among other matters:
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the results of our clinical trials;
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our financial prospects;
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our financing plans;
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trends affecting our financial condition or operating results;
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our strategies for growth, operations, and product development
and commercialization; and
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conditions or trends in or factors affecting the biotech
industry.
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You should understand that a number of factors could cause our
results to differ materially from those expressed in the
forward-looking statements. The information incorporated by
reference or provided in
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this prospectus identifies important factors that could cause
such differences. Those factors include, among others, the high
cost and uncertainty of technology and drug development, which
can result in loss of profitability and long delays in getting
products to market.
Where you can find
more information
We file annual, quarterly and special reports, proxy statements
and other information with the Securities and Exchange
Commission (the SEC). You may read and copy any
document we file at the SECs public reference room at
450 Fifth Street, N.W., Washington, D.C. 20549. You
may also obtain copies from the SECs public reference room by
mail at prescribed rates. Please call the SEC at
1-800-SEC-0330
for further information about the operation of the public
reference room. Our SEC filings are also available to the public
from the SECs web site at
http://www.sec.gov.
Information about La Jolla Pharmaceutical Company is also
available to the public from our website at
http://www.ljpc.com.
We have filed a registration statement on
Form S-3
with the SEC under the Securities Act of 1933, as amended. This
prospectus does not contain all of the information set forth in
the registration statement. You should read the registration
statement for further information about us and the securities.
You may inspect the registration statement and its exhibits
without charge at the office of the SEC at 450 Fifth
Street, N.W., Washington, D.C. 20549, and you may obtain
copies from the SEC at prescribed rates.
The SEC allows us to incorporate by reference the
information that we file with it, which means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is
considered to be part of this prospectus, except for any
information that is superseded by information that is included
directly in this prospectus. The information we file with the
SEC in the future will update and supersede this information. We
incorporate by reference the documents listed below and any
future filings we make with the SEC pursuant to
Section 13(a), 13(c), 14 or 15(d) of the Securities
Exchange Act of 1934, as amended, until we sell all of the
securities offered by this prospectus:
1. Our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2001;
2. Our Proxy Statement filed on April 11, 2002
for our 2002 Annual Meeting of Stockholders;
3. Our Quarterly Reports on
Form 10-Q
for the quarters ended March 31, 2002, June 30, 2002
and September 30, 2002;
4. Our Current Report on
Form 8-K,
filed on November 26, 2002;
5. The description of our common stock contained in
our Registration Statements on
Form 8-A,
filed on June 2, 1994, December 4, 1998 and
January 26, 2001; and
6. All documents we file with the SEC pursuant to
Sections 13(a), 13(c), 14 and 15(d) of the Exchange Act
after the date of this prospectus and prior to the termination
of the offering of the shares offered by this prospectus.
You may request a copy of any or all of the information
incorporated by reference in this prospectus at no cost by
writing or telephoning us at the following address or telephone
number:
Corporate Secretary
La Jolla Pharmaceutical Company
6455 Nancy Ridge Drive
San Diego, California 92121
(858) 452-6600
You should rely only on the information contained in this
prospectus. We have not authorized anyone else to provide you
with different information. We are not making an offer of these
securities in any state where the offer is not permitted. You
should not assume that the information in this prospectus is
accurate as of any date other than the date on the front of this
prospectus.
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$125,000,000
La Jolla
Pharmaceutical Company
Common
Stock
PROSPECTUS
December 12,
2002
PROSPECTUS
$77,000,000
Common
Stock
Preferred
Stock
Warrants
This prospectus relates to common stock, preferred stock and
warrants that we may sell from time to time in one or more
offerings up to a total public offering price of $77,000,000 (or
its equivalent in foreign or composite currencies) on terms to
be determined at the time of sale. We will provide specific
terms of these securities in supplements to this prospectus. You
should read this prospectus and any supplement carefully before
you invest. This prospectus may not be used to offer and sell
securities unless accompanied by a prospectus supplement for
those securities.
Our common stock is traded on The NASDAQ Global Market under the
symbol LJPC. On August 17, 2007, the closing
price for our common stock, as reported on The NASDAQ Global
Market, was $4.37 per share. Each prospectus supplement to this
prospectus will contain information, where applicable, as to any
other listing on any national securities exchange or The NASDAQ
Global Market of the securities covered by such prospectus
supplement.
These securities may be sold directly by us, through dealers or
agents designated from time to time, to or through underwriters
or through a combination of these methods. See Plan of
Distribution in this prospectus. We may also describe the
plan of distribution for any particular offering of these
securities in any applicable prospectus supplement. If any
agents, underwriters or dealers are involved in the sale of any
securities in respect of which this prospectus is being
delivered, we will disclose their names and the nature of our
arrangements with them in a prospectus supplement. The net
proceeds we expect to receive from any such sale will also be
included in a prospectus supplement.
Investing in our
securities involves a high degree of risk. See Risk
Factors on page 23 of this prospectus. We may include
updated or additional risk factors in an applicable prospectus
supplement under the heading Risk Factors. You
should review that section of the prospectus supplement for a
discussion of matters that investors in our securities should
consider.
Neither the
Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or
passed upon the adequacy or accuracy of this prospectus or any
accompanying prospectus supplement. Any representation to the
contrary is a criminal offense.
The date of this prospectus is August 23, 2007.
TABLE OF
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YOU SHOULD RELY
ONLY ON THE INFORMATION CONTAINED IN THIS PROSPECTUS, ANY
PROSPECTUS SUPPLEMENT OR ANY DOCUMENT TO WHICH WE HAVE REFERRED
YOU. WE HAVE NOT AUTHORIZED ANYONE ELSE TO PROVIDE YOU WITH
INFORMATION THAT IS DIFFERENT. THIS PROSPECTUS AND ANY
PROSPECTUS SUPPLEMENT MAY BE USED ONLY WHERE IT IS LEGAL TO SELL
THESE SECURITIES. THE INFORMATION IN THIS PROSPECTUS OR ANY
PROSPECTUS SUPPLEMENT IS CURRENT ONLY AS OF THE DATE ON THE
FRONT OF THESE DOCUMENTS.
About this prospectus
This prospectus is part of a Registration Statement that we
filed with the Securities and Exchange Commission, or the SEC,
using a shelf registration process. Under this shelf
process, we may sell any combination of the securities described
in this prospectus in one or more offerings up to a total public
offering price of $77,000,000 (or its equivalent in foreign or
composite currencies). This prospectus provides you with a
general description of the securities we may offer. Each time we
sell securities, we will provide a prospectus supplement that
will contain specific information about the securities being
offered and the terms of that offering. The prospectus
supplement may also add to, update or change information
contained in this prospectus. You should read both this
prospectus and any prospectus supplement together with the
additional information described under the heading Where
You Can Find More Information carefully before making an
investment decision.
Unless the context otherwise requires, in this prospectus,
LJPC, the Company, we,
us, our and similar names refer to
La Jolla Pharmaceutical Company and its subsidiary.
About La Jolla
Pharmaceutical Company
We are a biopharmaceutical company focused on developing
innovative pharmaceutical products to improve human health by
addressing unmet medical needs. Our lead product candidate,
Riquent, is designed to treat lupus renal disease by preventing
or delaying renal flares. Riquent is currently in a Phase 3
clinical trial under a Special Protocol Assessment and has been
granted Fast Track designation by the FDA.
Lupus renal disease is a chronic illness that can lead to
irreversible renal damage, renal failure and the need for
dialysis, and is a leading cause of death in lupus patients.
Lupus is an antibody-mediated disease caused by autoantibodies,
of which antibodies to double-stranded DNA, or dsDNA, are an
important subgroup. Riquent is designed to prevent or delay
renal flares by lowering the levels of circulating antibodies to
dsDNA, which are believed to cause lupus renal disease. Current
treatments for this autoimmune disorder often address only
symptoms of the disease, or nonspecifically suppress the normal
operation of the immune system, which can result in severe,
negative side effects and hospitalization. We believe that
Riquent has the potential to treat lupus renal disease without
these severe, negative side effects. The Lupus Foundation
estimates that there are approximately one million lupus
patients in the United States. We believe that 30% to 50% of
these lupus patients have renal disease.
We have also developed novel, orally-active, small-molecule SSAO
inhibitors for the treatment of autoimmune diseases and acute
and chronic inflammatory disorders. Preclinical studies have
shown that these inhibitors reduce disease activity in animal
models of multiple sclerosis, rheumatoid arthritis, inflammatory
bowel disease, stroke, systemic inflammation and acute
inflammation.
Corporate information
We were incorporated in the State of Delaware in 1989. Our
principal executive offices are located at 6455 Nancy Ridge
Drive, San Diego, California 92121 and our telephone number
is
(858) 452-6600.
Our website is located at www.ljpc.com. We make available on our
website, free of charge, a link to our Annual Report on
Form 10-K,
Quarterly Reports on
Form 10-Q,
Current Reports on
Form 8-K
and amendments to those reports as soon as practicable after we
electronically file such material with the Securities and
Exchange Commission, or SEC. The information contained on our
website is not part of this prospectus.
Risk factors
Investing in our securities involves risk. The prospectus
supplement applicable to each type or series of securities we
offer will contain a discussion of the risks applicable to an
investment in La Jolla
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Pharmaceutical Company and to the particular types of securities
that we are offering under that prospectus supplement. Prior to
making a decision about investing in our securities, you should
carefully consider the specific factors discussed under the
heading Risk Factors in the applicable prospectus
supplement, together with all of the other information contained
or incorporated by reference in the prospectus supplement or
appearing or incorporated by reference in this prospectus. You
should also consider the risks, uncertainties and assumptions
discussed under the heading Risk Factors included in
our most recent annual report on
Form 10-K,
as revised or supplemented by our most recent quarterly report
on
Form 10-Q,
each of which are on file with the SEC and are incorporated
herein by reference, and which may be amended, supplemented or
superseded from time to time by other reports we file with the
SEC in the future.
Description of
capital stock
On the date of this prospectus, our authorized capital stock
consists of 225,000,000 shares of common stock,
$0.01 par value per share, and 8,000,000 shares of
preferred stock, $0.01 par value per share. The following
is a description of our capital stock. The following summary of
our amended and restated certificate of incorporation, amended
and restated bylaws, and rights plan does not describe the
certificate, the bylaws, or the rights plan entirely. We urge
you to read our certificate, bylaws, and rights plan which are
incorporated by reference as exhibits to the registration
statement of which this prospectus is a part. See Where
You Can Find More Information and Incorporation by
Reference on page 28.
COMMON
STOCK
As further described in our other filings with the SEC and our
certificate, bylaws, and rights plan, the holders of our common
stock are entitled to one vote per share on all matters to be
voted upon by our stockholders. Holders of our common stock are
entitled to receive, when and if declared by the board of
directors from time to time, such dividends and other
distributions in cash, stock or property from our assets or
funds legally available for such purposes subject to any
dividend preferences that may be attributable to preferred stock
that may be authorized. In the event of our liquidation,
dissolution or winding up, after all liabilities and the holders
of each series of preferred stock, if any, have been paid in
full, the holders of our common stock are entitled to share
ratably in all remaining assets available for distribution.
American Stock Transfer & Trust Company is the
Transfer Agent and Registrar for the shares of our common stock.
Each outstanding share of our common stock is accompanied by a
right to purchase our preferred stock, our common stock or the
common stock of a successor company pursuant to the terms of a
rights agreement. Please refer to the discussion entitled
La Jolla Pharmaceutical Company Rights Plan
below.
PREFERRED
STOCK
Our board of directors has the authority, without further action
by stockholders, to issue up to 8,000,000 shares of
preferred stock in one or more series and to fix the powers,
designations, rights, preferences, privileges, qualifications,
and restrictions thereof, including dividend rights, conversion
rights, voting rights, rights and terms of redemption,
liquidation preferences and sinking fund terms, any or all of
which may be greater than the rights of our common stock. Our
board of directors, without further stockholder approval, can
issue preferred stock with voting, conversion, and other rights
that could adversely affect the voting power and other rights of
the holders of common stock. The issuance of preferred stock in
certain circumstances may have the effect of delaying, deferring
or preventing a change in control of La Jolla
Pharmaceutical Company, may discourage bids for our common stock
at a premium over the market price of the common stock, and may
adversely affect the market price of our common stock. As of the
date of this prospectus, there are no shares of our preferred
stock outstanding. If we offer any shares of preferred stock
under this prospectus, the specific
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rights, preferences and privileges of that series of preferred
stock will be described in the prospectus supplement for that
offering.
We have filed a certificate of designation with the Secretary of
State of the State of Delaware, which designates
100,000 shares of preferred stock as Series A Junior
Participating Preferred Stock in connection with our stockholder
rights plan, as described below. We refer to our Series A
Junior Participating Preferred Stock as our Series A
Preferred Shares. Except to the extent that a right to purchase
our Series A Preferred Shares accompanies each share of our
common stock, no shares of our Series A Junior
Participating Preferred Stock are covered by this prospectus.
LA JOLLA
PHARMACEUTICAL COMPANY RIGHTS PLAN
On November 19, 1998, our board of directors authorized and
declared a dividend of one right for each share of our common
stock. On December 3, 1998, we entered into a rights
agreement with American Stock Transfer &
Trust Company, as rights agent, and filed a Certificate of
Designation with the State of Delaware regarding our
Series A Preferred Shares. The Company paid the rights
dividend to the holders of record of common stock as of the
close of business on December 18, 1998. Common stock
certificates issued after December 18, 1998, and prior to
the Distribution Date (as defined in the rights agreement),
contain a notation incorporating the rights agreement by
reference. The rights agreement was subsequently amended to
eliminate the concept of continuing directors in
response to a clarification of Delaware law and to permit
certain stockholders to acquire more than 15% of our outstanding
common stock without triggering the rights agreement by amending
the definition of an acquiring person. Currently,
there are no separate rights certificates. Each right is
attached to each share of our common stock and trades
automatically with the common stock. Rights will not be
separable from common stock or exercisable, unless specified
events described in the rights agreement occur. Upon the
occurrence of the events described in the rights agreement, the
rights will separate from the common stock and may thereafter
become exercisable to purchase additional securities.
Description of
warrants
We may issue securities warrants for the purchase of preferred
stock or common stock. Securities warrants may be issued
independently or together with preferred stock or common stock
and may be attached to or separate from any offered securities.
Each series of securities warrants will be issued under a
separate warrant agreement to be entered into between us and a
warrant agent. The securities warrant agent will act solely as
our agent in connection with the securities warrants and will
not assume any obligation or relationship of agency or trust for
or with any registered holders of securities warrants or
beneficial owners of securities warrants. This summary of some
provisions of the securities warrants is not complete. You
should refer to the applicable prospectus supplement and the
securities warrant agreement, including the forms of securities
warrant certificate representing the securities warrants,
relating to the specific securities warrants being offered for
the complete terms of the securities warrant agreement and the
securities warrants. That securities warrant agreement, together
with the terms of securities warrant certificate and securities
warrants, will be filed with the SEC in connection with the
offering of the specific securities warrants.
The particular terms of any issue of securities warrants will be
described in the prospectus supplement relating to the issue.
Those terms may include:
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the title of such warrants;
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the aggregate number of such warrants;
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the price or prices at which such warrants will be issued;
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the currency or currencies (including composite currencies) in
which the price of such warrants may be payable;
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the terms of the securities purchasable upon exercise of such
warrants and the procedures and conditions relating to the
exercise of such warrants;
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the price at which the securities purchasable upon exercise of
such warrants may be purchased;
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the date on which the right to exercise such warrants will
commence and the date on which such right shall expire;
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any provisions for adjustment of the number or amount of
securities receivable upon exercise of the warrants or the
exercise price of the warrants;
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if applicable, the minimum or maximum amount of such warrants
that may be exercised at any one time;
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if applicable, the designation and terms of the securities with
which such warrants are issued and the number of such warrants
issued with each such security;
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if applicable, the date on and after which such warrants and the
related securities will be separately transferable;
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information with respect to book-entry procedures, if any; and
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any other terms of such warrants, including terms, procedures
and limitations relating to the exchange or exercise of such
warrants.
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The prospectus supplement relating to any warrants to purchase
equity securities may also include, if applicable, a discussion
of certain U.S. federal income tax and ERISA considerations.
Securities warrants for the purchase of preferred stock and
common stock will be offered and exercisable for
U.S. dollars only. Securities warrants will be issued in
registered form only.
Each securities warrant will entitle its holder to purchase the
number of shares of preferred stock or common stock at the
exercise price set forth in, or calculable as set forth in, the
applicable prospectus supplement.
After the close of business on the expiration date, unexercised
securities warrants will become void. We will specify the place
or places where, and the manner in which, securities warrants
may be exercised in the applicable prospectus supplement.
Upon receipt of payment and the warrant certificate properly
completed and duly executed at the corporate trust office of the
warrant agent or any other office indicated in the applicable
prospectus supplement, we will, as soon as practicable, forward
the purchased securities. If less than all of the warrants
represented by the warrant certificate are exercised, a new
warrant certificate will be issued for the remaining warrants.
Prior to the exercise of any securities warrants to purchase
preferred stock or common stock, holders of the securities
warrants will not have any of the rights of holders of preferred
stock or common stock purchasable upon exercise, including the
right to vote or to receive any payments of dividends on the
preferred stock or common stock purchasable upon exercise.
Use of proceeds
Unless we tell you otherwise in a prospectus supplement, we will
use the net proceeds from the sale of these securities for
general corporate purposes, which may include funding clinical
trials, research and development, regulatory activities and
product marketing, including acquisitions of companies,
products, intellectual property or other technology, repayment
or refinancing of existing indebtedness, investments, capital
expenditures, repurchase of our capital stock and for any other
purposes that we may specify in any prospectus supplement. We
may also invest the net proceeds temporarily in short-term or
marketable securities until we use them for their stated purpose.
Plan of distribution
The securities that may be offered pursuant to this prospectus
and any prospectus supplement may be offered by us to one or
more underwriters for public offering and sale by them, to
investors directly
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(through a specific bidding or auction process, or otherwise) or
through agents. Any such underwriter or agent involved in the
offer and sale of such securities will be named in the
applicable prospectus supplement. Sales of such securities may
be effected from time to time in one or more types of
transactions, which may include block transactions, on the
NASDAQ Global Market or other securities exchange, in the
over-the-counter market, in negotiated transactions, through put
or call options transactions relating to the securities, through
short sales of the securities, or a combination of such methods
of sale. Such transactions may or may not involve brokers or
dealers. The prospectus supplement with respect to the
securities being offered will set forth the terms of the
offering of those securities, including the names of the
underwriters, dealers or agents, if any, the purchase price, the
net proceeds to us, any underwriting discounts and other items
constituting underwriters compensation, the public
offering price, any discounts or concessions allowed or
reallowed or paid to dealers and any securities exchanges on
which such securities may be listed.
Underwriters may offer and sell the securities at a fixed price
or prices, which may be changed, at market prices prevailing at
the time of sale, at prices related to such prevailing market
prices or at negotiated prices. The consideration may be cash or
another form negotiated by the parties. If underwriters are used
in an offering, we will execute an underwriting agreement with
such underwriters and will specify the name of each underwriter
and the terms of the transaction (including any underwriting
discounts and other terms constituting compensation of the
underwriters and any dealers) in a prospectus supplement. The
securities may be offered to the public either through
underwriting syndicates represented by managing underwriters or
directly by one or more investment banking firms or others, as
designated. If an underwriting syndicate is used, the managing
underwriter(s) will be specified on the cover of the prospectus
supplement. If underwriters are used in the sale, the offered
securities will be acquired by the underwriters for their own
accounts and may be resold from time to time in one or more
transactions, including negotiated transactions, at a fixed
public offering price or at varying prices determined at the
time of sale. Any public offering price and any discounts or
concessions allowed or reallowed or paid to dealers may be
changed from time to time. Unless otherwise set forth in the
prospectus supplement, the obligations of the underwriters to
purchase the offered securities will be subject to conditions
precedent and the underwriters will be obligated to purchase all
of the offered securities if any are purchased.
In connection with the sale of the securities, we may grant to
the underwriters options to purchase additional securities to
cover over-allotments, if any, at the public offering price,
with additional underwriting commissions or discounts, as may be
set forth in a related prospectus supplement. The terms of any
over-allotment option will be set forth in the prospectus
supplement for those securities. Underwriters may also receive
compensation from us in the form of underwriting discounts,
concessions or commissions and may also receive commissions from
purchasers of the securities for whom they may act as agent.
Underwriters may sell the securities to or through dealers who
may receive compensation from the underwriters in the form of
discounts, concessions or commissions or commissions from the
purchasers for whom they may act as agents.
If any underwriters are involved in the offer and sale, they
will be permitted to engage in transactions that maintain or
otherwise affect the price of the securities. These transactions
may include over-allotment transactions, purchases to cover
short positions created by the underwriter in connection with
the offering and the imposition of penalty bids. If an
underwriter creates a short position in the securities in
connection with the offering, i.e., if it sells more securities
than set forth on the cover page of the applicable prospectus
supplement, the underwriter may reduce that short position by
purchasing the securities in the open market. In general,
purchases of a security to reduce a short position could cause
the price of the security to be higher than it might be in the
absence of such purchases. As noted above, underwriters may also
choose to impose penalty bids on other underwriters
and/or
selling group members. This means that if underwriters purchase
securities on the open market to reduce their short position or
to stabilize the price of the securities, they may reclaim the
amount of the selling concession from those underwriters
and/or
selling group members who sold such securities as part of the
offering.
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Neither we nor any underwriter make any representation or
prediction as to the direction or magnitude of any effect that
the transactions described above may have on the price of such
securities. In addition, neither we nor any underwriter make any
representation that such underwriter will engage in such
transactions or that such transactions, once commenced, will be
discontinued without notice.
Direct sales of securities may be made on a national securities
exchange or otherwise.
Dealers and agents participating in the distribution of the
securities may be deemed to be underwriters, and any discounts
and commissions received by them and any profit realized by them
on resale of the securities may be deemed to be underwriting
discounts and commissions under the Securities Act of 1933, as
amended. Underwriters, dealers, agents and remarketing firms
described below may be entitled, under agreements entered into
with us, to indemnification against and contribution toward
certain civil liabilities, including liabilities under the
Securities Act of 1933, as amended. The terms of any
indemnification provisions will be set forth in a prospectus
supplement.
Certain of the underwriters, dealers, agents and remarketing
firms and their associates may engage in transactions with, and
perform services for, us in the ordinary course of business.
We may directly solicit offers to purchase the securities and we
may make sales of securities directly to institutional investors
or others. These persons may be deemed to be underwriters within
the meaning of the Securities Act of 1933, as amended, with
respect to any resales of the securities. To the extent
required, the prospectus supplement will describe the terms of
any such sales, including the terms of any bidding or auction
process, if used.
Under the securities laws of some states, the securities offered
by the prospectus may be sold in those states only through
registered or licensed brokers or dealers.
It is possible that one or more underwriters may make a market
in our common stock, but the underwriters will not be obligated
to do so and may discontinue any market making at any time
without notice. We cannot give any assurance as to the liquidity
of the trading market for our common stock.
If dealers are used in an offering, we will sell the securities
to the dealers as principals. The dealers then may resell the
securities to the public at varying prices, which they determine
at the time of resale. The names of the dealers and the terms of
the transaction will be specified in a prospectus supplement.
The securities may be sold directly by us or through agents we
designate from time to time at a fixed price or prices, which
may be changed, or at varying prices determined at the time of
sale. If agents are used in an offering, the names of the agents
and the terms of the agency will be specified in a prospectus
supplement. Unless otherwise indicated in a prospectus
supplement, the agents will act on a best-efforts basis for the
period of their appointment.
Offered securities may also be offered and sold, if so indicated
in the applicable prospectus supplement, in connection with a
remarketing upon their purchase, in accordance with a redemption
or repayment pursuant to their terms, or otherwise, by one or
more remarketing firms acting as principals for their own
accounts or as agents for us. Any remarketing firm will be
identified and the terms of its agreements, if any, with us, and
its compensation will be described in the applicable prospectus
supplement. Remarketing firms may be deemed to be underwriters,
as that term is defined in the Securities Act of 1933, as
amended, in connection with the securities marketed by them.
If we so indicate in the prospectus supplement, we may authorize
agents, underwriters or dealers to solicit offers from certain
purchasers to purchase securities from us at the public offering
price set forth in the applicable prospectus supplement pursuant
to delivery contracts providing for payment and delivery on a
future date.
Each series of securities will be a new issue of securities and
will have no established trading market (other than our common
stock). Any common stock sold pursuant to a prospectus
supplement will be listed on NASDAQ, subject to official notice
of issuance. Any underwriters to whom securities are sold by us
for public offering and sale may make a market in the
securities, but such underwriters will not
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be obligated to do so and may discontinue any market making at
any time without notice. The securities, other than the common
stock, may or may not be listed on a national securities
exchange or eligible for quotation on any other trading or
quotation system.
Legal matters
The validity of the securities offered hereby will be passed
upon for us by Goodwin Procter LLP, San Diego, California.
If counsel for any underwriters passes on legal matters in
connection with an offering of the securities described in this
prospectus, we will name that counsel in the prospectus
supplement relating to that offering.
Experts
Ernst & Young LLP, independent registered public
accounting firm, has audited our consolidated financial
statements included in our Annual Report on
Form 10-K
for the year ended December 31, 2006, as set forth in their
report, which is incorporated by reference in this prospectus
and elsewhere in the registration statement. Our financial
statements are incorporated by reference in reliance on
Ernst & Young LLPs report, given on their
authority as experts in accounting and auditing.
Where you can find
more information and incorporation by reference
We file annual, quarterly and special reports, proxy statements
and other information with the Securities and Exchange
Commission, or the SEC. You may read and copy any document we
file at the SECs public reference room at
100 F Street, N.E., Washington, D.C., 20549. You
may also obtain copies from the SECs public reference room
by mail at prescribed rates. Please call the SEC at
1-800-SEC-0330
for further information about the operation of the public
reference room. Our SEC filings are also available to the public
from the SECs web site at
http://www.sec.gov.
Information about La Jolla Pharmaceutical Company is also
available to the public from our website at
http://www.ljpc.com.
The SEC allows us to incorporate by reference the
information that we file with it, which means that we can
disclose important information to you by referring you to those
documents. The information incorporated by reference is
considered to be part of this prospectus, and information that
we file later with the SEC will automatically update and
supersede information in this prospectus. We incorporate by
reference the documents listed below and any future filings we
make with the SEC pursuant to Section 13(a), 13(c), 14 or
15(d) of the Securities Exchange Act of 1934, as amended, until
this offering is completed:
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Our Annual Report on
Form 10-K
for the fiscal year ended December 31, 2006.
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Our Quarterly Report on
Form 10-Q
for the quarter ended March 31, 2007.
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Our Quarterly Report on
Form 10-Q
for the quarter ended June 30, 2007.
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Our Current Reports on
Form 8-K
filed with the SEC on February 1, 2007, February 9,
2007, March 8, 2007, March 20, 2007, March 30,
2007, April 27, 2007 (excluding the matters in
Item 7.01 and Exhibit 99.1, therein, which are not
incorporated by reference into this Registration Statement),
May 10, 2007 (excluding the matters in Item 7.01 and
Exhibit 99.1, therein, which are not incorporated by
reference into this Registration Statement) and August 1,
2007.
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The description of our capital stock contained in our
Registration Statements on
Form 8-A,
filed on June 2, 1994 and on December 4, 1998, and the
post-effective amendments thereto, filed on January 26,
2001, December 12, 2005 and March 1, 2006.
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Each person to whom a copy of this prospectus is delivered may
request a copy of any or all of the information incorporated by
reference in this prospectus, including the exhibits to any
filings
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incorporated by reference herein, at no cost by writing or
telephoning us at the following address or telephone number:
Corporate Secretary
La Jolla Pharmaceutical Company
6455 Nancy Ridge Drive
San Diego, California 92121
(858) 452-6600
You should rely only on the information contained in this
prospectus. We have not authorized anyone else to provide you
with different information. We are not making an offer of these
securities in any state where the offer is not permitted. You
should not assume that the information in this prospectus is
accurate as of any date other than the date on the front of this
prospectus.
Forward-looking
statements
We have made forward-looking statements in this prospectus that
are based on our managements beliefs and assumptions and
on information currently available to our management.
Forward-looking statements include information concerning our
possible or assumed future results of operations and statements
preceded by, followed by, or that include the words
believes, expects,
anticipates, intends, plans,
estimates or similar expressions.
Forward-looking statements involve risks, uncertainties and
assumptions. Actual results may differ materially from those
expressed in these forward-looking statements. You are cautioned
not to put undue reliance on any forward-looking statements. The
forward-looking statements made in this prospectus, as well as
the information that we have previously filed with the
Securities and Exchange Commission and incorporated by
reference, is accurate only as of the date of the applicable
document. We undertake no obligation to update any
forward-looking statement to reflect events or circumstances
after the date on which the statement is made or to reflect the
occurrence of unanticipated events. These forward-looking
statements appear in a number of places in this prospectus and
include statements regarding our intentions, plans, strategies,
beliefs or current expectations and those of our directors or
our officers. You should understand that a number of factors
could cause our results to differ materially from those
expressed in the forward-looking statements. The information
incorporated by reference or provided in this prospectus
identifies important factors that could cause such differences.
Those factors include, among others, the high cost and
uncertainty of technology and drug development, as well as
regulatory approvals, which can result in loss of profitability
and long delays in getting products to market, and other factors
discussed in Risk Factors and elsewhere in this
prospectus and the documents incorporated by reference.
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