e424b3
Filed Pursuant to Rule 424(b)(3)
Registration No. 333-131246
PROSPECTUS
LA JOLLA PHARMACEUTICAL COMPANY
21,999,985 Shares
Common Stock
This prospectus relates to the sale or other disposition of up
to 21,999,985 shares of common stock of La Jolla
Pharmaceutical Company, or interests therein, by the selling
stockholders named in this prospectus, and their transferees,
consisting of (i) 17,599,993 shares (post-reverse
stock split) of our common stock (the Shares)
issued to the selling stockholders pursuant to a Securities
Purchase Agreement, dated as of October 6, 2005 (the
Securities Purchase Agreement), among us and the
selling stockholders and (ii) 4,399,992 shares
(post-reverse stock split) of our common stock (the
Warrant Shares) issuable upon exercise of warrants
issued to the selling stockholders pursuant to the Securities
Purchase Agreement (the Closing Warrants). The
selling stockholders acquired the Shares and the Closing
Warrants pursuant to the Securities Purchase Agreement in a
private placement transaction not involving a public offering.
The selling stockholders may, from time to time, sell, transfer
or otherwise dispose of any or all of their shares of common
stock or interests in shares of common stock on any stock
exchange, market or trading facility on which the shares are
traded or in private transactions. These dispositions may be at
fixed prices, at prevailing market prices at the time of sale,
at prices related to the prevailing market price, at varying
prices determined at the time of sale, or at negotiated prices.
See Plan of Distribution on page 17.
We will not receive any proceeds from any sale or disposition of
the shares registered hereunder or interests therein. The
selling stockholders will receive all of the net proceeds from
the sale or disposition of such shares, or interests therein,
and pay all selling commissions, if any, applicable to any sale.
We are responsible for payment of all other expenses incurred in
connection with the registration of the shares hereunder.
Our common stock is traded on the Nasdaq National Market under
the symbol LJPC. On January 23, 2006, the last
reported sale price of our common stock was $4.30 per share.
You should read this prospectus carefully before you invest.
INVESTING IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK.
SEE RISK FACTORS BEGINNING ON PAGE 1.
Neither the Securities and Exchange Commission nor any state
securities commission has approved or disapproved these
securities or determined if this prospectus is truthful or
complete. Any representation to the contrary is a criminal
offense.
The information in this prospectus is not complete and may be
changed. These securities will not be sold until the
registration statement filed with the Securities and Exchange
Commission is effective. This prospectus is not an offer to sell
these securities and it is not soliciting an offer to buy these
securities in any state where the offer or sale is not permitted.
The date of this prospectus is February 3, 2006
LA JOLLA PHARMACEUTICAL COMPANY
La Jolla Pharmaceutical Company was incorporated in
Delaware in 1989. In October 2004, we established a subsidiary,
La Jolla Limited, which was organized in England in
connection with the potential development efforts for
Riquent®
in Europe. We are 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, are caused by abnormal B cell production of antibodies
that attack healthy tissues. Current treatments for these
autoimmune disorders 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 our drug candidates, called
Toleragens®,
have the potential to treat the underlying cause of many
antibody-mediated diseases without these severe, negative side
effects.
We are registering 21,999,985 shares of our common stock,
consisting of 17,599,993 Shares and 4,399,992 Warrant
Shares issuable upon the exercise of the Closing Warrants, for
resale or other disposition by the selling stockholders. We
previously issued the Shares and the Closing Warrants to the
selling stockholders pursuant to the Securities Purchase
Agreement in a private placement transaction. The selling
stockholders are identified in the section of this prospectus
under the heading Selling Stockholders. We will not
receive any of the proceeds from the sale or other disposition
of the shares registered hereunder, or interests therein. We
will, however, receive proceeds from the exercise of any Closing
Warrants for cash. If all of the Closing Warrants were exercised
for cash, we would receive proceeds of approximately
$21,999,960, which we currently intend to use for general
corporate purposes.
We remain 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.
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. Some of these factors have
significantly 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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RISK FACTORS RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND
THE INDUSTRY IN WHICH WE OPERATE. |
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Results from our clinical trials may not be sufficient to
obtain approval to market Riquent 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. 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 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 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 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. 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.
Because Riquent is our only drug candidate for which we have
completed a Phase 3 clinical trial, and because there is no
guarantee that we would be able to develop an alternate drug
candidate, our inability to obtain regulatory approval of
Riquent would have a severe negative effect on our business,
and, in the future, we may not have the financial resources to
continue research and development of Riquent or any other
potential drug candidates.
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In order to complete our ongoing clinical trial of
Riquent, we will need to enroll 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. |
We expect that the ongoing clinical trial of Riquent will
involve approximately 600 patients, which is significantly
more than were involved in our Phase 3 trial. In order to
complete this trial, we will need to locate and enroll a
sufficient number of patients who meet the criteria for the
trial. 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. If we
are unable to timely enroll a sufficient number of patients, we
will not be able to complete successfully the ongoing trial. As
a result, it may be difficult or impossible for us to continue
to operate.
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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, we limited
patient enrollment in our ongoing clinical benefit trial in an
effort to reduce costs. This could have the effect of
significantly delaying the completion of the trial. 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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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 products are not effective; |
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patients experience negative side effects or other safety
concerns are raised during treatment; or |
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the trials are not conducted in accordance with applicable
clinical practices. |
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.
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We may be required to design and conduct additional
trials. |
We may be required to design and conduct additional studies to
further demonstrate the safety and efficacy of our drug
candidates, 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 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 the safety
or efficacy of our drug candidates. 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 future clinical results are positive.
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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. 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. Application of our
technology to antibody-mediated diseases other than lupus is in
earlier research stages. 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.
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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 have implemented a commercial scale manufacturing
process for Riquent but we have not yet manufactured an entire
lot of Riquent at the current scale. If we are unable to
manufacture Riquent in accordance with applicable FDA good
manufacturing practices at the current scale, our ability to
timely complete clinical trials of Riquent will be negatively
affected.
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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.
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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
will be required to enable us to manufacture Riquent, if
approved, in significant commercial quantities. We have limited
manufacturing experience, and we may be unable to successfully
transition to commercial production.
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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 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
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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. |
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.
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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.
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If we are to obtain regulatory approval of Riquent, we
must validate our manufacturing facilities and processes. |
Although a successful pre-approval inspection was conducted by
the FDA in July 2004, we have never operated a commercial
manufacturing facility and we have not yet validated our
manufacturing processes. 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.
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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. |
We have currently budgeted only a limited amount of funds for
the development of small molecules for the treatment of
autoimmune diseases and acute and chronic inflammatory
disorders. Substantial future development of these drug
candidates may depend on our ability to obtain third party
financing for this program. As a result, significant 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.
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Our operations depend on 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 Riquent 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 other key members of our senior management team to assist us
with, among other matters, manufacturing, clinical development,
regulatory and potential commercialization activities.
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Retaining our current personnel and recruiting additional
personnel will be critical to our success. |
Retaining our current key personnel to perform clinical
development, manufacturing, regulatory, research and
development, 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, research and development, business
development, 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, scientific, 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,
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, research
and development, 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.
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Our efforts to obtain approval to market Riquent in Europe
may be delayed or unsuccessful. |
In order to obtain approval to market Riquent in Europe we must
submit a Marketing Authorization Application (an
MAA) to and pass inspections of the European health
authority. Ultimately, a representative from each of the
European Member States will vote on whether to approve the MAA.
Upon receiving the MAA, the Committee for Human Medicinal
Products, a division of the European Medicines Agency
(EMEA), will review the MAA and respond to us with a
number of questions. The approval process may be delayed
because, among other matters: the answers to the questions posed
by the EMEA may require additional tests to be conducted to
obtain the answers to the questions posed; we, or one of our
contract manufacturing facilities, may be unable to successfully
pass an inspection by the European health authority; or the
European health authority ultimately may not accept the data
presented in the MAA in combination with our proposals for
post-authorization commitments as adequate for approval under
the EMEA exceptional circumstances regulation. The
exceptional circumstances regulation is a path to approval in
Europe that may be available when the comprehensive assessment
of a products efficacy or safety is not possible at the
time of filing because of the rarity of the indication, the
state of scientific knowledge, or the means by which such
information would be gathered is contrary to medical ethics. In
addition, we must manufacture three consecutive lots of Riquent
to validate our manufacturing process as part of our MAA. If we
encounter difficulties in successfully completing this component
of the MAA, our application will not be complete and approval
will not be granted. Even if we receive approval in Europe under
the exceptional circumstances regulation, we will be required to
complete several post-authorization commitments, including a
long-term clinical efficacy study, the progress of which will be
reviewed frequently by the European health authorities. If we
fail to successfully complete these activities to the
satisfaction of the European health authorities, our license to
market Riquent in Europe, if any, could be revoked.
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We may not have sufficient financial resources to complete
the ongoing clinical benefit trial of Riquent. |
We will need to successfully complete the ongoing clinical
benefit study of Riquent prior to FDA approval. We expect that
the ongoing clinical benefit trial will involve approximately
600 patients and take several years to complete. Although
we recently raised net proceeds of approximately
$62 million from the sale of common stock and warrants, the
actual costs of completing the ongoing clinical benefit trial of
Riquent may exceed our current cash resources. In that case, if
we expend all of the funds that we recently raised and do not
receive funding from a collaborative agreement with a corporate
partner or obtain other financing, we will not have the
financial resources to complete the ongoing clinical benefit
trial or to continue the research and development of Riquent,
and it will be difficult or impossible for us to continue to
operate.
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We will need additional funds to support our
operations. |
Our operations to date have consumed substantial capital
resources. Before we can obtain FDA approval for Riquent, our
drug candidate for lupus renal disease, we will need to
successfully complete the ongoing clinical benefit trial and
possibly additional trials. Therefore, we expect to expend
substantial amounts of capital resources for additional
research, product development, pre-clinical testing and clinical
trials of Riquent and any additional drug candidates. 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
$62 million from the Securities Purchase Agreement, we
expect that 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 research and development
programs; |
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the size and complexity of our research and 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. |
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 research and development
activities. If we ultimately 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 have
adequate resources to support continuation of our business
activities.
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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 expect that 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 delay, scale back or eliminate one or more
of our research and development programs, which may include
delaying or halting the ongoing clinical benefit trial of
Riquent, 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, your investment in us will
be diluted, and dilution can be particularly substantial when
the price of our common stock is low.
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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
research, 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 the costs of completing the
ongoing clinical benefit trial of Riquent significantly exceed
our estimates and 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 and approved, to
manufacture, market and sell them successfully.
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Our blood test to measure the binding affinity for Riquent
has not been validated by independent laboratories and is likely
to require regulatory review as part of the Riquent approval
process. |
In 1998, we developed a blood test that we believe can identify
the lupus patients who are most likely to respond to Riquent.
The blood test is designed to measure the strength of the
binding between Riquent and a patients antibodies. This
affinity assay was used to identify, prospectively in the
Phase 3 trial and retrospectively in the Phase 2/3
trial, the patients included in the efficacy analyses.
Independent laboratories have not validated the assay, and the
results of the affinity assay observed in our clinical trials of
Riquent may not be observed in the broader lupus patient
population. Although the FDA has reviewed the blood assay as
part of the approval process of Riquent, the FDAs review
of the assay will not be complete until after Riquent is
approved, if ever, and we and the FDA agree upon the label for
Riquent. In addition, foreign regulatory authorities may require
that the assay be reviewed as part of their approval process for
Riquent. Even if Riquent and the assay are approved by the FDA
or foreign regulatory authorities, we may have to conduct
additional studies on the assay post-approval. The testing
laboratory that will conduct the assay if Riquent is approved
may also require additional regulatory approval. If the FDA or
foreign regulatory authorities do not concur with the use of the
assay to identify potential patients for treatment with Riquent,
or if any of them requires additional studies on the assay or
additional regulatory approval of the testing laboratory, the
approval and possible commercialization of Riquent may be
delayed or prevented, which would have a severe negative effect
on our business.
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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
any of our 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.
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Even if we receive regulatory approval for our product
candidates, we will be subject to ongoing regulatory obligations
and review. |
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 current good manufacturing practices. 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.
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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
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 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
Riquent.
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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.
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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
8
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.
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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 that we can generate from sales of future
products, if any. 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.
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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
$254.3 million as of September 30, 2005. 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, regulatory and research 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 develop 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.
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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. As of December 2,
2005, we owned 105 issued patents and 76 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.
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 investigations to
date, we currently do not believe that these patent families are
likely to impede the advancement of our drug candidates,
including Riquent.
9
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. |
We could incur substantial costs 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.
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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 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 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.
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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. 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 the
benefits afforded by the orphan drug designation will ultimately
be determined by the FDA only after further review of our New
Drug Application.
10
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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.
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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.
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II. |
RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK. |
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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 maintain a market
in our stock. |
In 2005, we received a notice from Nasdaq that our stock price
fell below the Nasdaq 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, Nasdaq 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 you to sell the shares
that you own. This would have a negative effect on the price and
liquidity of our stock.
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The ownership of our common stock is concentrated. |
As of January 20, 2006, our three largest stockholders
beneficially owned or controlled approximately 55% of our common
stock. 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 stockholders, either directly or
indirectly, have the ability to significantly influence the
outcome of all matters submitted to a vote of our stockholders.
11
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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. Recent corporate events have
caused our stock price to be particularly 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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actions or decisions by the FDA and other comparable agencies; |
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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 us or
our 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, 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.
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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 January 20,
2006, there were:
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Approximately 14,920,722 shares of common stock that have
been issued in registered offerings or were otherwise freely
tradable in the public markets, excluding the
21,999,985 shares of common stock, including shares of
common stock subject to warrants, registered hereby. |
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Approximately 13,810 shares of common stock eligible for
resale in the public market pursuant to SEC Rule 144. |
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2,225,504 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
$15.47 per share. |
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Approximately 3,278,357 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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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 January 20, 2006, there was $53,937,500 of our common
stock available for future issuance. |
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 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.
12
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Failure to achieve and maintain effective internal
controls 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 controls over financial
reporting in all 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 attest to, and report on, managements assessment of our
internal controls over financial reporting. We evaluated our
internal controls over financial reporting as of
December 31, 2004 in order to comply with Section 404
and concluded that our disclosure controls and procedures were
effective as of such date. In addition, our independent
registered public accounting firm reported on our assertion with
respect to the effectiveness of our internal controls over
financial reporting as of December 31, 2004. 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 assure you that we will be able to conclude in
the future that we have effective internal controls over
financial reporting in accordance with Section 404. If we
fail to achieve and maintain a system of effective internal
controls, it could have a material adverse effect on our
business and stock price.
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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.
USE OF PROCEEDS
We will not receive any proceeds from the sale or other
disposition by the selling stockholders of the shares registered
hereunder, or interests therein. We will, however, receive
proceeds from the exercise of any Closing Warrants for cash. If
all of the Closing Warrants were exercised for cash, we would
receive proceeds of approximately $21,999,960, which we
currently intend to use for general corporate purposes.
SELLING STOCKHOLDERS
In a private placement transaction completed on
December 14, 2005, we issued a total of
88,000,000 shares (pre-reverse stock split) of our common
stock and Closing Warrants to purchase an additional
22,000,000 shares (pre-reverse stock split) of our common
stock to the selling stockholders listed below. On
December 21, 2005, we filed an amendment to our certificate
of incorporation that caused each five outstanding shares of our
common stock to be converted into one share of our common stock.
We are registering the shares of common stock sold to the
selling stockholders, and the shares of common stock issuable
upon exercise of the Closing Warrants, which, on a post-reverse
split basis, consist of the 17,599,993 Shares and the
4,399,992 Warrant Shares. The selling stockholders may from time
to time sell or dispose of pursuant to this prospectus any or
all of the 17,599,993 Shares, or interests therein, and,
upon
13
exercise of the Closing Warrants pursuant to the terms thereof,
any or all of the 4,399,992 Warrant Shares, or interests
therein. The following table describes, as of January 20,
2006, the number of Shares and Warrant Shares that each selling
stockholder beneficially owns and the number of shares
registered hereunder. The term selling stockholders
includes the holders listed below and their transferees,
pledgees, donees or other successors. We have prepared this
table based upon information furnished to us by or on behalf of
the selling stockholders.
The selling stockholders confirmed at the time they acquired the
shares constituting the Shares and, to the extent any Closing
Warrants have been exercised, the shares constituting the
Warrant Shares acquired upon such exercise, that they acquired
such shares for investment purposes only and not with a view
towards, or for resale in connection with, the public sale or
distribution thereof. This offering relates only to the sale of
the 17,599,993 Shares and the 4,399,992 Warrant Shares held
or to be held by the selling stockholders named in the following
table. Since the date on which they provided us with the
information below, the selling stockholders may have sold,
transferred or otherwise disposed of some or all of their Shares
or Warrant Shares in transactions exempt from the registration
requirements of the Securities Act.
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Beneficial Ownership | |
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Beneficial Ownership | |
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Prior to Offering | |
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After Offering | |
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Number of Shares | |
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Percent of | |
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Shares to | |
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Number of | |
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Percent of Class | |
Name of Beneficial Owner |
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and Warrant Shares | |
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Class (%)(1) | |
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be Sold(2) | |
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Shares(2) | |
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(%)(1)(2) | |
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Essex Woodlands Health Ventures Fund VI, L.P.(3)
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8,333,332 |
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24.4 |
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8,333,332 |
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Frazier Healthcare V, LP(4)
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5,000,000 |
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14.9 |
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5,000,000 |
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Alejandro Gonzalez Cimadevilla(5)
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5,138,256 |
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15.5 |
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3,666,666 |
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1,471,590 |
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4.5 |
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Domain Public Equity Partners, L.P.(6)
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1,500,000 |
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4.6 |
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1,500,000 |
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Special Situations Fund III, L.P.(7)(8)
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109,835 |
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* |
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96,038 |
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13,797 |
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* |
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Special Situations Fund III QP, L.P.(7)(9)
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1,253,025 |
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3.8 |
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1,095,628 |
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157,397 |
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* |
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Special Situations Cayman Fund, L.P.(7)(10)
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369,723 |
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1.1 |
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320,832 |
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48,891 |
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* |
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Special Situations Private Equity Fund, L.P.(7)(11)
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338,032 |
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1.0 |
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320,832 |
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17,200 |
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* |
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Special Situations Life Sciences Fund, L.P.(7)(12)
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222,906 |
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* |
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166,666 |
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56,240 |
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* |
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Sutter Hill Ventures, a California limited partnership(13)
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1,118,733 |
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3.4 |
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1,118,733 |
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Anvest, L.P.(14)
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8,332 |
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* |
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8,332 |
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G. Leonard Baker, Jr. and Mary Anne Baker, Co-Trustees of
the Baker Revocable Trust U/ A/ D 2/3/03(15)
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34,009 |
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* |
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34,009 |
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Saunders Holdings, L.P.(16)
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34,009 |
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* |
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34,009 |
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William H. Younger, Jr. and Lauren L. Younger, Co-Trustees
of the Younger Living Trust U/ A/ D 1/20/95(17)
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39,006 |
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* |
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39,006 |
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Tench Coxe and Simone Otus Coxe, Co- Trustees of the Coxe
Revocable Trust U/ A/ D 4/23/98(18)
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67,151 |
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* |
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67,151 |
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James C. Gaither(19)
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15,811 |
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* |
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15,811 |
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14
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Beneficial Ownership | |
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Beneficial Ownership | |
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Prior to Offering | |
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After Offering | |
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Number of Shares | |
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Percent of | |
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Shares to | |
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Number of | |
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Percent of Class | |
Name of Beneficial Owner |
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and Warrant Shares | |
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Class (%)(1) | |
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be Sold(2) | |
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Shares(2) | |
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(%)(1)(2) | |
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| |
|
| |
|
| |
|
| |
|
| |
Jeffrey W. Bird and Christina R. Bird as Trustees of Jeffrey W.
and Christina R. Bird Trust Agreement Dated 10/31/00(20)
|
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26,103 |
|
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|
* |
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26,103 |
|
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|
|
|
|
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Robert Yin and Lily Yin as Trustees of Yin Family
Trust Dated March 1, 1997(21)
|
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1,410 |
|
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* |
|
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1,410 |
|
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|
|
|
|
|
|
|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO
Sherryl W. Hossack(22)
|
|
|
1,875 |
|
|
|
* |
|
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|
1,875 |
|
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|
|
|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO David L.
Anderson(23)
|
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41,636 |
|
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* |
|
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41,636 |
|
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|
|
|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO
William H. Younger, Jr.(24)
|
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39,006 |
|
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|
* |
|
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|
39,006 |
|
|
|
|
|
|
|
|
|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO Tench
Coxe(25)
|
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59,785 |
|
|
|
* |
|
|
|
59,785 |
|
|
|
|
|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO David E.
Sweet(26)
|
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1,325 |
|
|
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* |
|
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|
1,325 |
|
|
|
|
|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO David E.
Sweet (Rollover)(27)
|
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6,730 |
|
|
|
* |
|
|
|
6,730 |
|
|
|
|
|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO
Lynne M. Brown(28)
|
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2,250 |
|
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* |
|
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2,250 |
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|
|
|
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|
Wells Fargo Bank, N.A. FBO SHV Profit Sharing Plan FBO Patricia
Tom (Post)(29)
|
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2,820 |
|
|
|
* |
|
|
|
2,820 |
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
This table includes the number of shares underlying warrants
that are exercisable within 60 days from January 20,
2006. All information with respect to beneficial ownership is
based on filings made by the respective beneficial owners with
the SEC or information provided to us by such beneficial owners.
Except as indicated in the footnotes to this table, the persons
named in the table have sole voting and investment power with
respect to all shares of common stock shown as beneficially
owned by them, subject to community property laws. On
January 20, 2006, there were 32,534,525 shares of
common stock outstanding. Shares not outstanding that are
subject to warrants exercisable by the holder thereof within
60 days of January 20, 2006 are deemed outstanding for
the purposes of calculating the number and percentage owned by
such stockholder, but not deemed outstanding for the purpose of
calculating the percentage owned by each other stockholder
listed. |
|
|
(2) |
Assumes all the shares of common stock that may be offered
hereunder are sold. |
|
|
(3) |
Includes 1,666,666 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. Essex
Woodlands Health Ventures VI, L.P. (the GP
Partnership) is the general partner of Essex Woodlands
Health Ventures Fund VI, L.P. (the
Partnership). Essex Woodlands Health Ventures VI,
L.L.C. (the General Partner) is the general partner
of the GP Partnership. James L. Currie, Martin P. Sutter,
Immanuel Thangaraj, Jeff Himawan, Ph.D., Mark Pacala and
Petri Vainio, |
15
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|
|
|
|
MD, Ph.D. (the Managers) are managers of the
General Partner. Mr. Sutter is also one of our directors.
By virtue of the relationships among the Partnership, the GP
Partnership, the General Partner and the Managers (collectively,
the Essex Persons), each may be deemed to share
voting power and investment power over the shares reported as
owned by the Partnership in the above table. Each of the Essex
Persons expressly disclaim beneficial ownership of any shares of
common stock, except for such securities for which such Essex
Person is the holder of record and except to the extent of the
Essex Persons proportionate pecuniary interests therein.
The shares reported in the above table do not include any shares
held by any Manager in his individual capacity. |
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(4) |
Includes 1,000,000 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days.
FHM V, LP is the general partner of Frazier
Healthcare V, LP. FHM V, LLC is the general partner of
FHM V, LP. Nader J. Naini is a managing member of FHM V LLC
and serves as one of our directors. James N. Topper is a member
of the investment committee of FHM V LLC and serves as one of
our directors. By virtue of the relationships among Frazier
Healthcare V, LP, FHM V, LP, FHM V, LLC,
Mr. Naini and Mr. Topper (collectively, the
Frazier Persons), each may be deemed to share voting
power and investment power over the shares reported as owned by
Frazier Healthcare V, LP in the above table. Each of the
Frazier Persons expressly disclaim beneficial ownership of any
shares of common stock, except for such securities for which
such Frazier Person is the holder of record and except to the
extent of the Frazier Persons proportionate pecuniary
interests therein. |
|
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(5) |
Includes 733,333 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
|
(6) |
Includes 300,000 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
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(7) |
MGP Advisors Limited (MGP) is the general partner of
Special Situations Fund III, L.P. and Special Situations
Fund III QP, L.P. AWM Investment Company, Inc.
(AWM) is the general partner of MGP and the general
partner of and investment adviser to the Special Situations
Cayman Fund, L.P. MG Advisers, L.L.C. (MG) is the
general partner of and investment adviser to the Special
Situations Private Equity Fund, L.P. LS Advisers, LLC
(LS) is the general partner and investment adviser
to the Special Situations Life Sciences Fund, L.P. Austin W.
Marxe and David M. Greenhouse are the principal owners of MGP,
AWM, MG and LS. Through their control of MGP, AWM, MG and LS,
Mr. Marxe and Mr. Greenhouse share voting and
investment control over the portfolio securities of each of the
funds listed above. |
|
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(8) |
Includes 19,207 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
|
(9) |
Includes 219,126 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
|
(10) |
Includes 64,166 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(11) |
Includes 64,166 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(12) |
Includes 33,333 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(13) |
Includes 223,746 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(14) |
Includes 1,666 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(15) |
Includes 6,802 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(16) |
Includes 6,802 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
16
|
|
(17) |
Includes 7,801 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(18) |
Includes 13,429 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(19) |
Includes 3,162 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(20) |
Includes 5,220 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(21) |
Includes 282 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(22) |
Includes 375 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(23) |
Includes 8,327 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(24) |
Includes 7,801 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(25) |
Includes 11,957 shares issuable upon the exercise of
Closing Warrants that are exercisable within 60 days. |
|
(26) |
Includes 265 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(27) |
Includes 1,346 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(28) |
Includes 450 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
|
(29) |
Includes 564 shares issuable upon the exercise of Closing
Warrants that are exercisable within 60 days. |
The information regarding the selling stockholders may change
from time to time. If required, we will describe these changes
in one or more prospectus supplements.
PLAN OF DISTRIBUTION
The selling stockholders, which as used herein includes donees,
pledgees, transferees or other
successors-in-interest
selling shares of common stock or interests in shares of common
stock received after the date of this prospectus from a selling
stockholder as a gift, pledge, partnership distribution or other
transfer, may, from time to time, sell, transfer or otherwise
dispose of any or all of their shares of common stock or
interests in shares of common stock on any stock exchange,
market or trading facility on which the shares are traded or in
private transactions. These dispositions may be at fixed prices,
at prevailing market prices at the time of sale, at prices
related to the prevailing market price, at varying prices
determined at the time of sale, or at negotiated prices.
The selling stockholders may use any one or more of the
following methods when disposing of shares or interests therein:
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ordinary brokerage transactions and transactions in which the
broker-dealer solicits purchasers; |
|
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|
block trades in which the broker-dealer will attempt to sell the
shares as agent, but may position and resell a portion of the
block as principal to facilitate the transaction; |
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purchases by a broker-dealer as principal and resale by the
broker-dealer for its account; |
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an exchange distribution in accordance with the rules of the
applicable exchange; |
|
|
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privately negotiated transactions; |
|
|
|
short sales effected after the effective date of the
registration statement of which this prospectus is a part; |
17
|
|
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|
through the writing or settlement of options or other hedging
transactions, whether through an options exchange or otherwise; |
|
|
|
agreements with broker-dealers to sell a specified number of
such shares at a stipulated price per share; and |
|
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|
a combination of any such methods of sale. |
The selling stockholders may, from time to time, pledge or grant
a security interest in some or all of the shares of common stock
owned by them and, if they default in the performance of their
secured obligations, the pledgees or secured parties may offer
and sell the shares of common stock, from time to time, under
this prospectus, or under an amendment to this prospectus under
Rule 424(b)(3) or other applicable provision of the
Securities Act amending the list of selling stockholders to
include the pledgee, transferee or other successors in interest
as selling stockholders under this prospectus. The selling
stockholders also may transfer the shares of common stock in
other circumstances, in which case the transferees, pledgees or
other successors in interest will be the selling beneficial
owners for purposes of this prospectus.
In connection with the sale of our common stock or interests
therein, the selling stockholders may enter into hedging
transactions with broker-dealers or other financial
institutions, which may in turn engage in short sales of the
common stock in the course of hedging the positions they assume.
The selling stockholders may also sell shares of our common
stock short and deliver these securities to close out their
short positions, or loan or pledge the common stock to
broker-dealers that in turn may sell these securities. The
selling stockholders may also enter into option or other
transactions with broker-dealers or other financial institutions
or the creation of one or more derivative securities which
require the delivery to such broker-dealer or other financial
institution of shares offered by this prospectus, which shares
such broker-dealer or other financial institution may resell
pursuant to this prospectus (as supplemented or amended to
reflect such transaction).
The aggregate proceeds to the selling stockholders from the sale
of the common stock offered by them will be the purchase price
of the common stock less discounts or commissions, if any. Each
of the selling stockholders reserves the right to accept and,
together with their agents from time to time, to reject, in
whole or in part, any proposed purchase of common stock to be
made directly or through agents. We will not receive any of the
proceeds from this offering. Upon any exercise of the warrants
by payment of cash, however, we will receive the exercise price
of the warrants.
The selling stockholders also may resell all or a portion of the
shares in open market transactions in reliance upon
Rule 144 under the Securities Act, provided that they meet
the criteria and conform to the requirements of that rule.
The selling stockholders and any underwriters, broker-dealers or
agents that participate in the sale of the common stock or
interests therein may be underwriters within the
meaning of Section 2(11) of the Securities Act. Any
discounts, commissions, concessions or profit they earn on any
resale of the shares may be underwriting discounts and
commissions under the Securities Act. Selling stockholders who
are underwriters within the meaning of
Section 2(11) of the Securities Act will be subject to the
prospectus delivery requirements of the Securities Act.
To the extent required, the shares of our common stock to be
sold, the names of the selling stockholders, the respective
purchase prices and public offering prices, the names of any
agents, dealer or underwriter, and any applicable commissions or
discounts with respect to a particular offer will be set forth
in an accompanying prospectus supplement or, if appropriate, a
post-effective amendment to the registration statement that
includes this prospectus.
In order to comply with the securities laws of some states, if
applicable, the common stock may be sold in these jurisdictions
only through registered or licensed brokers or dealers. In
addition, in some states the common stock may not be sold unless
it has been registered or qualified for sale or an exemption
from registration or qualification requirements is available and
is complied with.
We have advised the selling stockholders that the
anti-manipulation rules of Regulation M under the Exchange
Act may apply to sales of shares in the market and to the
activities of the selling stockholders and
18
their affiliates. In addition, we will make copies of this
prospectus (as it may be supplemented or amended from time to
time) available to the selling stockholders for the purpose of
satisfying the prospectus delivery requirements of the
Securities Act. The selling stockholders may indemnify any
broker-dealer that participates in transactions involving the
sale of the shares against certain liabilities, including
liabilities arising under the Securities Act.
We have agreed to indemnify the selling stockholders against
liabilities, including liabilities under the Securities Act and
state securities laws, relating to the registration of the
shares offered by this prospectus.
We have agreed with the selling stockholders to keep the
registration statement of which this prospectus constitutes a
part effective until the earlier of (1) such time as all of
the shares covered by this prospectus have been disposed of
pursuant to and in accordance with the registration statement or
(2) the date on which the shares may be sold pursuant to
Rule 144(k) of the Securities Act.
WHERE YOU CAN FIND MORE INFORMATION
We file periodic reports, proxy statements and other information
with the Securities and Exchange Commission. You may inspect and
copy these reports and other information at the SECs
public reference room in Washington, D.C., located at 100 F
Street, N.E., Washington, D.C. 20549. You can also obtain
copies of these materials from the SECs public reference
room at prescribed rates. Please call the SEC at
1-800-SEC-0330 for
further information about its public reference room. The SEC
also maintains a site on the World Wide Web at
http://www.sec.gov. This site contains reports, proxy and
information statements and other information about registrants
that file electronically with the SEC.
The SEC permits us to incorporate by reference the
information and reports we file with it. This means that we can
disclose important information to you by referring to another
document. The information that we incorporate by reference is
considered to be part of this prospectus, and later information
that we file with the SEC automatically updates and supersedes
this information. Specifically, we incorporate by reference:
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1. Our Annual Report on
Form 10-K for the
fiscal year ended December 31, 2004; |
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2. Our Quarterly Reports on
Form 10-Q for the
quarters ended March 31, 2005, June 30, 2005 and
September 30, 2005; |
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|
3. Our Current Reports on
Form 8-K filed on
January 28, 2005, February 2, 2005, February 17,
2005, March 14, 2005, March 28, 2005, March 30,
2005, March 30, 2005, April 22, 2005, April 29,
2005, May 20, 2005, May 31, 2005, June 3, 2005,
October 7, 2005, October 26, 2005, November 15,
2005, December 2, 2005, December 14, 2005,
December 16, 2005, December 21, 2005, January 11,
2006 and January 12, 2006; |
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4. The description of our common stock contained in our
Registration Statements on
Form 8-A, filed on
June 2, 1994 and December 4, 1998, and on
Form 8-A/ A, filed
on January 26, 2001 and December 16, 2005; and |
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5. 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. |
We have also filed a registration statement on
Form S-3 with the
SEC. 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 our
common stock.
19
We will provide a copy of these filings to each person,
including any beneficial owner, receiving this prospectus, upon
written or oral request. You may request a copy of these filings
at no cost by writing or telephoning us at the following address
and 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 authorized no one 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.
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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our clinical development, regulatory and manufacturing plans; |
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|
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the results of our clinical trials; |
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our financial prospects; |
|
|
|
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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|
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conditions or trends in or factors affecting the biotech
industry. |
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 these differences. Those factors
include, among others, the high cost and uncertainty of
technology and drug development, which can result in significant
losses and long delays in getting products to market.
20
LEGAL MATTERS
The validity of the shares of common stock covered by this
prospectus was passed upon by Gibson, Dunn & Crutcher
LLP, Orange County, California.
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, 2004, and our managements assessment of
the effectiveness of our internal control over financial
reporting as of December 31, 2004, as set forth in their
reports, which are incorporated by reference in this prospectus
and elsewhere in the registration statement. Our financial
statements and managements assessment are incorporated by
reference in reliance on Ernst & Young LLPs reports,
given on their authority as experts in accounting and auditing.
21
NO
PERSON HAS BEEN AUTHORIZED IN CONNECTION WITH ANY OFFERING MADE
UNDER THIS PROSPECTUS TO GIVE ANY INFORMATION OR TO MAKE ANY
REPRESENTATIONS OTHER THAN THOSE CONTAINED IN THIS PROSPECTUS.
IF GIVEN OR MADE, SUCH INFORMATION OR REPRESENTATIONS MUST NOT
BE RELIED UPON AS HAVING BEEN AUTHORIZED BY US OR THE SELLING
STOCKHOLDERS. NEITHER THE DELIVERY OF THIS PROSPECTUS NOR ANY
SALE MADE UNDER THIS PROSPECTUS WILL, UNDER ANY CIRCUMSTANCES,
IMPLY THAT THERE HAS BEEN NO CHANGE IN OUR AFFAIRS OR THAT THE
INFORMATION IN THIS PROSPECTUS IS CORRECT AS OF ANY TIME
SUBSEQUENT TO THE DATE AS OF WHICH THE INFORMATION IS GIVEN.
THIS PROSPECTUS DOES NOT CONSTITUTE AN OFFER TO SELL OR THE
SOLICITATION OF ANY OFFER TO BUY ANY OF THE SECURITIES OFFERED
UNDER THIS PROSPECTUS TO ANYONE IN ANY JURISDICTION IN WHICH THE
OFFER OR SOLICITATION IS NOT AUTHORIZED OR IN WHICH THE PERSON
MAKING THE OFFER OR SOLICITATION IS NOT QUALIFIED TO DO SO OR TO
ANYONE TO WHOM IT IS UNLAWFUL TO MAKE THE OFFER OR SOLICITATION.
TABLE OF CONTENTS
LA JOLLA PHARMACEUTICAL COMPANY
21,999,985 Shares
Common Stock
PROSPECTUS
February 3, 2006