Form 10-K
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-K
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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the fiscal year ended DECEMBER 31, 2009
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-24274
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
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Delaware
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33-0361285 |
(State or other jurisdiction
of incorporation or organization)
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(I.R.S. Employer
Identification Number) |
4365 Executive Drive, Suite 300, San Diego, CA 92121
(Address of principal executive offices, including Zip Code)
Registrants telephone number, including area code: (858) 452-6600
Securities registered pursuant to Section 12(b) of the Act:
Securities registered pursuant to Section 12(g) of the Act:
Common Stock, Par Value $0.01 per share
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule
405 of the Securities Act. Yes o No þ
Indicate by check mark if the registrant is not required to file reports pursuant to Section
13 or 15(d) of the Act. Yes o No þ
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files). Yes o No o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation
S-K is not contained herein, and will not be contained, to the best of registrants knowledge, in
definitive proxy or information statements incorporated by reference in Part III of the Form 10-K
or any amendment to this Form 10-K. o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated
filer, a non-accelerated filer, or a smaller reporting company. See the definitions of large
accelerated filer, accelerated filer and smaller reporting company in Rule 12b-2 of the
Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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(Do not check if a smaller reporting company) |
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of
the Exchange Act). Yes o No þ
The aggregate market value of voting and non-voting common stock held by non-affiliates of the
registrant as of June 30, 2009 totaled approximately $12,042,000 based on the closing price of
$0.19 as reported by the Nasdaq Global Market. As of April 6, 2010, there were 65,722,648 shares of
the Companys common stock ($0.01 par value) outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
None
FORWARD-LOOKING STATEMENTS
The forward-looking statements in this report involve significant risks, assumptions and
uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to
differ materially from our current expectations. Forward-looking statements include those that
express a plan, belief, expectation, estimation, anticipation, intent, contingency, future
development or similar expression. Accordingly, you should not rely upon forward-looking
statements as predictions of future events. The outcome of the events described in these
forward-looking statements are subject to the risks, uncertainties and other factors described in
Managements Discussion and Analysis of Financial Condition and Results of Operations and in the
Risk Factors contained in this Annual Report on Form 10-K, and in other reports and registration
statements that we file with the Securities and Exchange Commission from time to time. We expressly
disclaim any intent to update forward-looking statements.
PART I
In this report, all references to we, our, us and the Company refer to La Jolla
Pharmaceutical Company, a Delaware corporation, and our wholly owned
subsidiaries La Jolla Limited (dissolved during October 2009) and
Jewel Merger Sub, Inc.
Overview
La Jolla Pharmaceutical Company was incorporated in Delaware in 1989. We are a
biopharmaceutical company that has historically focused on the development and testing of Riquent
as a treatment for Lupus nephritis. Lupus is an antibody-mediated disease caused by abnormal B cell
production of antibodies that attack healthy tissues. Current treatments for this autoimmune
disorder often address only symptoms of the disease, or nonspecifically suppress the normal
operation of the immune system, which can result in severe, negative side effects and
hospitalization. From August 2004 to February 2009, Riquent was being studied in a double-blinded
multicenter Phase 3 clinical trial, called the ASPEN trial.
On January 4, 2009, we entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited (BioMarin CF), a wholly-owned
subsidiary of BioMarin Pharmaceutical Inc. (BioMarin Pharma). Under the terms of the
Development Agreement, BioMarin CF was granted co-exclusive rights to develop and commercialize
Riquent in the United States, Europe and all other territories of the world, excluding the Asia
Pacific region, and the non-exclusive right to manufacture Riquent anywhere in the world. In
January 2009, BioMarin CF paid us a non-refundable commencement payment of $7.5 million and
BioMarin Pharma purchased $7.5 million of a newly designated series of our preferred stock. As
described below, this agreement was terminated on March 27, 2009. See Note 4 to our audited
consolidated financial statements included in Part IV.
In February 2009, we were informed by an Independent Monitoring Board for the Riquent Phase 3
ASPEN study that the monitoring board completed their review of the first interim efficacy analysis
of Riquent and determined that continuing the study was futile. We subsequently unblinded the data
and found that there was no statistical difference in the primary endpoint, delaying time to renal
flare, between the Riquent-treated group and the placebo-treated group, although there was a
significant difference in the reduction of antibodies to double-stranded DNA. There were 56 renal
flares in 587 patients treated with either 300-mg or 900-mg of Riquent, and 28 renal flares in 283
patients treated with placebo.
Based on these results, we immediately discontinued the Riquent Phase 3 ASPEN study and the
further development of Riquent. We had previously devoted substantially all of our research,
development and clinical efforts and financial resources toward the development of Riquent. In
connection with the termination of our clinical trials for Riquent, we subsequently took steps to
significantly reduce our operating costs, including a substantial reduction in personnel, which was
completed in April 2009. We also ceased the manufacture of Riquent at our former facility in San
Diego, California as well as all regulatory activities associated
with Riquent. See Note 6 to our consolidated financial statements included in Part IV.
Following the futile results of the first interim efficacy analysis of Riquent, BioMarin CF
elected to not exercise its full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties terminated on March 27, 2009 in
accordance with its terms. Pursuant to the Securities Purchase Agreement between us and BioMarin
Pharma, all of the Companys preferred shares purchased by BioMarin Pharma were converted into
common shares. Additionally, all rights to Riquent were returned
to us. See Note 4 to our
consolidated financial statements included in Part IV.
In July 2009, we announced that, in light of the alternatives available to us at that time, a
wind down of our business would be in the best interest of our stockholders. Although our Board of
Directors approved a Plan of Complete Liquidation and Dissolution (the Plan of Dissolution) in
September 2009, it was subject to approval by holders of at least a majority in voting power of our
outstanding shares. We called a special meeting of stockholders to vote on the Plan of
Dissolution; however, the majority of our stockholders failed to return their proxy cards or
otherwise indicate their votes with respect to this proposal. As a result, in November 2009,
we cancelled the special meeting of stockholders and began to evaluate other strategic
opportunities.
1
In December 2009, we signed a definitive merger agreement with Adamis Pharmaceuticals
Corporation (Adamis) and our direct wholly-owned subsidiary, Jewel Merger Sub, Inc. (Merger
Sub) wherein Merger Sub would merge with and into Adamis and Adamis would survive the merger as a
wholly-owned subsidiary of La Jolla. The merger required certain proposals to be approved by our
stockholders including the issuance of our common stock to Adamis stockholders and effecting a
significant reverse split of our common stock. We called a special meeting of stockholders to vote
on the merger-related proposals. In early March 2010, the Company and Adamis agreed to terminate
the Merger Agreement as a result of too few of our stockholders voting on the proposals related to
the Merger such that we did not have the requisite quorum to hold the stockholders meeting.
In light of our apparent inability to complete a strategic transaction that requires
stockholder approval, we are currently evaluating what options are available to us to maximize the value of our assets, which may include the following:
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Sell or out-license our Riquent program, although we may not receive any
significant value upon any such sale or license; |
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Pursue potential other strategic transactions for new technologies, which
could include mergers, license agreements or other collaborations, with third parties
where we acquire new compounds for development and seek additional capital; or |
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Implement a wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company. |
Following the negative results of the ASPEN trial, we recorded a significant charge for the
impairment of our Riquent assets, including our Riquent-related patents, and we may not realize any
significant value from these assets in the future. Additionally, there is a substantial risk that
we may not successfully implement any of these strategic alternatives, and even if we determine to
pursue one or more of these alternatives, we may be unable to do so on acceptable terms. Any such
transactions may be highly dilutive to our existing stockholders and may deplete our limited
remaining capital resources.
Patents and Proprietary Technologies
All of our issued and pending patents were written off or sold during the year ended December
31, 2009. In order to conserve cash, we have stopped paying patent maintenance and prosecution
costs on our Riquent related patents, and will need to either reinstate these patents by paying
back fees or let them lapse. At the present time, we are considering whether there continues to be
potential value in the Riquent patent estate. To the extent that there is believed to be value
with these assets, we would need to pay approximately
$0.1 million in fees to reinstate these patents
and patent applications.
Competition
The biotechnology and pharmaceutical industries are extremely competitive. Many companies have
substantially greater financial and other resources than we do. In addition, they may have
substantially more experience in effecting strategic combinations, in-licensing technology,
developing drugs, obtaining regulatory approvals, and manufacturing and marketing products. We
cannot give any assurances that we can effectively compete with these other pharmaceutical and
biotechnology companies.
Government Regulation
Governmental authorities in the U.S. and other countries extensively regulate, among other
things, the research, development, testing, manufacture, labeling, promotion, advertising,
distribution, and marketing of products produced by the biotechnology and pharmaceutical industry.
In the United States the Food and Drug Administration (the FDA) regulates drugs under the Federal
Food, Drug, and Cosmetic Act and its implementing
regulations. Outside the U.S., the requirements governing conduct of clinical trials and
marketing authorization vary widely from country to country, but involve a similar degree of
oversight and rigor as in the U.S.
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Employees
As of March 5, 2010, we employed three regular full-time employees (including one person who
has an M.D.). Other personnel resources are used from time to time as consultants on an as-needed
basis. In connection with the termination of the clinical trials for Riquent, we ceased all
manufacturing and regulatory activities related to Riquent and took steps to significantly reduce
our operating costs, including a reduction of force that resulted in the termination of the majority
of our employees, primarily in April 2009. See Note 6 to our consolidated financial statements
included in Part IV. None of our employees are covered by collective bargaining agreements and
management considers relations with our employees to be good.
Available Information
Our annual reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K,
and amendments to those reports filed with or furnished to the Securities and Exchange Commission
pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, are
available free of charge through our website at www.ljpc.com as soon as reasonably practicable
after we electronically file or furnish the reports with or to the Securities and Exchange
Commission.
I. RISK FACTORS RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND THE INDUSTRY IN WHICH WE OPERATE.
We
have only limited assets, no ongoing clinical trials and no products, and will need to raise additional capital if we are to continue as a
going concern.
As
of December 31, 2009, we had approximately $4.2 million in
working capital, no ongoing clinical trials and no products. Although we
retain the rights to the Riquent patent estate, the value of the estate is uncertain and has been
written down under United States generally accepted accounting
principles (GAAP) to nearly zero. As a result, we have only limited assets available to
operate and develop our business. If we determine that Riquent has no remaining value, then we
would either need to acquire rights to another drug candidate for development or choose to
liquidate the Company. If we determine that Riquent does have potential value such that it merits
further development efforts, we would need to find a development partner and/or raise significant
amounts of additional capital to attempt to develop the compound ourselves. Given the limited
working capital that we have available, we will need to raise significant amounts of additional
capital if we elect to not liquidate the Company, Raising this capital may not be possible or, if
possible, may be on terms that are highly unfavorable. For example, because our stock price is so
depressed, raising a significant amount of capital would result in the issuance of a very large
number of shares. This would greatly dilute the ownership of our existing stockholders and would
likely provide the new investor with a controlling interest in the Company. Additionally, we may
find it necessary to agree to unfavorable investment terms, with terms such as preemptive rights,
anti-dilution adjustments, special approval rights, and other terms that could provide new
investors with a greater degree of control over the Company. The existence of these terms could
negatively affect the value of our common stock and could diminish the rights of our existing
stockholders. We may not continue in business and may liquidate the
Company.
Although we are attempting to pursue potential strategic transactions, there is no assurance that
we will be successful.
Following the failure of Riquent in February 2009 we have been exploring strategic
alternatives to maximize stockholder value, as described above. There is a substantial risk that
we may not successfully implement any of these strategic alternatives, particularly in light of our
recent inability to obtain stockholder approval of various transactions, and even if we determine
to pursue one or more of these alternatives, we may be unable to do so on acceptable financial
terms. Any such transactions may require us to incur non-recurring or other charges and may pose
significant integration challenges and/or management and business disruptions, any of which could
materially
and adversely affect our business and financial results. Additionally, pursuing these
transactions would deplete some portion of our limited capital resources and may not result in a
transaction that is ultimately consummated.
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Stockholders should recognize that in our efforts to address our liabilities and fund the
future development of our Company, we may pursue strategic alternatives that result in the
stockholders of the Company having little or no continuing interest in the assets or equity of the
Company. We will continue to evaluate our alternatives in light of our cash position, including the
possibility that we may ultimately seek to liquidate the Company.
If we choose to liquidate the Company, it is unlikely that stockholders would receive any
significant value for their shares.
We have not generated any revenues from product sales, and have incurred losses in each year
since our inception in 1989. We expect that it will be very difficult to raise capital to continue
our operations and our independent registered public accounting firm has issued an opinion with an
explanatory paragraph to the effect that there is substantial doubt about our ability to continue
as a going concern. We do not believe that we could succeed in raising additional capital needed to
sustain our operations without some strategic transaction, such as a merger or other third-party
collaboration. If we are unable to consummate such a transaction, we expect that we would need to
cease all operations and wind down. Although we are currently evaluating our strategic alternatives
with respect to all aspects of our business, we cannot assure you that any actions that we take
would raise or generate sufficient capital to fully address the uncertainties of our financial
position. As a result, we may be unable to realize value from our assets and discharge our
liabilities in the normal course of business. If we are unable to consummate a strategic
transaction, we would likely need to liquidate the Company. The funds resulting from the
liquidation of our assets, net of amounts payable, would likely return only a small amount, if
anything, to our stockholders. See Liquidity and Capital Resources in Part II, Item 7,
Managements Discussion and Analysis of Financial Condition and Results of Operations and Note 1
to our consolidated financial statements included elsewhere in this Annual Report on Form 10-K.
II. RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK.
The recent delisting of our common stock could have a substantial effect on the price and liquidity
of our common stock.
On March 4, 2010, our common stock was delisted from the Nasdaq Capital Market and we began
trading on The Pink OTC Markets, Inc. (The Pink Sheets). As a result of trading on The Pink
Sheets, the market liquidity of our common stock may be adversely affected and the market price of
our common stock may decrease. Trading on The Pink Sheets may also adversely affect our ability to
effect a strategic transaction, such as a merger with a third party. In addition, our stockholders
ability to trade or obtain quotations on our shares may be severely limited because of lower
trading volumes and transaction delays. These factors may contribute to lower prices and larger
spreads in the bid and ask price for our common stock.
Specifically, you may not be able to resell your shares at or above the price you paid for
such shares or at all. In addition, class action litigation has often been instituted against
companies whose securities have experienced periods of volatility in market price. Any such
litigation brought against us could result in substantial costs and a diversion of managements
attention and resources, which could hurt our business, operating results and financial condition.
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The price of our common stock has been, and will be, volatile and may continue to decline.
Our stock has experienced significant price and volume volatility since February 2009 due to,
among other things, the futility determination of the Riquent clinical trial in February 2009 and
the termination of our merger agreement with Adamis in March 2010. Our stock is currently trading
below $0.10 per share and we could continue to experience further declines in our stock price. The
market price of our common stock has been and is likely to continue to be highly volatile. Market
prices for securities of biotechnology and pharmaceutical companies, including ours, have
historically been highly volatile, and the market has from time to time experienced significant
price and volume fluctuations that are unrelated to the operating performance of particular
companies. The following factors, among others, can have a significant effect on the market price
of our securities:
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limited financial resources; |
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announcements regarding mergers or other strategic transactions; |
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future sales of significant amounts of our common stock by us or our
stockholders; |
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developments in patent or other proprietary rights; |
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developments concerning potential agreements with collaborators; and |
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general market conditions and comments by securities analysts. |
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.
Anti-takeover devices may prevent changes in our board of directors and management.
We have in place several anti-takeover devices, 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.
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Item 1B. |
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Unresolved Staff Comments. |
None.
None.
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Item 3. |
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Legal Proceedings. |
We are not currently a party to any legal proceedings.
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PART II
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Item 5. |
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Market For Registrants Common Equity, Related Stockholder Matters and Issuer Purchases of
Equity Securities. |
Information About Our Common Stock
During the year ended December 31, 2009, our common stock traded on the Nasdaq Global and
Capital Markets under the symbol LJPC. As of March 4, 2010, our common stock was delisted from
the Nasdaq Capital Market and began trading on the Pink OTC Markets, under the symbol LJPC.PK.
Set forth below are the high and low sales prices for our common stock for each full quarterly
period within the two most recent fiscal years.
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Prices |
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High |
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Low |
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Year Ended December 31, 2009 |
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First Quarter |
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3.20 |
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0.04 |
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Second Quarter |
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0.64 |
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0.13 |
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Third Quarter |
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0.36 |
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0.14 |
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Fourth Quarter |
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0.32 |
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0.06 |
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Year Ended December 31, 2008 |
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First Quarter |
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$ |
4.25 |
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$ |
1.45 |
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Second Quarter |
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2.35 |
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1.59 |
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Third Quarter |
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2.50 |
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1.01 |
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Fourth Quarter |
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1.20 |
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0.43 |
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We have never paid dividends on our common stock and we do not anticipate paying dividends in
the foreseeable future. The number of record holders of our common stock as of March 5, 2010 was
approximately 289.
Information About Our Equity Compensation Plans
Information regarding our equity compensation plans is incorporated by reference in Item 12 of
Part III of this annual report on Form 10-K.
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Item 6. |
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Selected Financial Data |
We are a smaller reporting company as defined by Rule 12b-2 of the Exchange Act and are not
required to provide the information required under this item.
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Item 7. |
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Managements Discussion and Analysis of Financial Condition and Results of Operations. |
Introduction
Managements discussion and analysis of financial condition and results of operations is
provided as a supplement to the accompanying consolidated financial statements and footnotes to
help provide an understanding of our financial condition, the changes in our financial condition
and our results of operations. Our discussion is organized as follows:
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Overview and recent developments. This section provides a general description of our
business and operating history and a general description of recent events and significant
transactions that we believe are important in understanding our financial condition and
results of operations. |
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Critical accounting policies and estimates. This section contains a discussion of the
accounting policies that we believe are important to our financial condition and results of
operations and that require significant judgment and estimates on the part of management in
their application. In addition, all of our significant accounting policies, including the
critical accounting policies and estimates, are summarized in Note 1 to the accompanying
consolidated financial statements. |
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Results of operations. This section provides an analysis of our results of operations
presented in the accompanying consolidated statements of operations by comparing the
results for the year ended December 31, 2009 to the results for the year ended December 31,
2008. |
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Liquidity and capital resources. This section provides an analysis of our cash flows as
well as material subsequent changes. |
Overview and Recent Developments
Since our inception in May 1989, we have devoted substantially all of our resources to the
research and development of technology and potential drugs to treat antibody-mediated diseases. We
have never generated any revenue from product sales and have relied on public and private offerings
of securities, revenue from collaborative agreements, equipment financings and interest income on
invested cash balances for our working capital.
On January 4, 2009, we entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited (BioMarin CF), a wholly-owned
subsidiary of BioMarin Pharmaceutical Inc. (BioMarin Pharma). Under the terms of the
Development Agreement, BioMarin CF was granted co-exclusive rights to develop and commercialize
Riquent in the United States, Europe and all other territories of the world, excluding the Asia
Pacific region, and the non-exclusive right to manufacture Riquent anywhere in the world. In
January 2009, BioMarin CF paid us a non-refundable commencement payment of $7.5 million and
BioMarin Pharma paid $7.5 million for a newly designated series of our preferred stock. As
described below, this agreement was terminated on March 27,
2009. See Note 4 to our consolidated financial statements included in Part IV.
Following the futile results of the first interim efficacy analysis of Riquent, BioMarin CF
elected to not exercise its full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties terminated on March 27, 2009 in
accordance with its terms. Pursuant to the Securities Purchase Agreement between us and BioMarin
Pharma, all of the Companys preferred shares purchased by BioMarin Pharma were converted into
common shares upon the termination of the Development Agreement. Additionally, all rights to
Riquent were returned to us. See Note 4 to our consolidated financial statements
included in Part IV.
In February 2009, we were informed by an Independent Monitoring Board for the Riquent Phase 3
ASPEN study that the monitoring board completed its review of the first interim efficacy analysis
of Riquent and determined that continuing the study was futile. We subsequently unblinded the data
and found that there was no statistical difference in the primary endpoint, delaying time to renal
flare, between the Riquent-treated group and the placebo-treated group, although there was a
significant difference in the reduction of antibodies to double-stranded DNA.
There were 56 renal flares in 587 patients treated with either 300-mg or 900-mg of Riquent,
and 28 renal flares in 283 patients treated with placebo.
7
Based on these results, we immediately discontinued the Riquent Phase 3 ASPEN study and the
further development of Riquent. We had previously devoted substantially all of our research,
development and clinical efforts and financial resources toward the development of Riquent. In
connection with the termination of our clinical trials for Riquent, we subsequently took steps to
significantly reduce our operating costs, including a substantial reduction in personnel, which was
completed in April 2009. We also ceased the manufacture of Riquent at our former facility in
San Diego, California. See Note 6 to our consolidated financial statements included in Part
IV.
In July 2009, we announced that, in light of the alternatives available to us at the time, a
wind down of our business would be in the best interests of the Company and its stockholders.
Although the Board of Directors (the Board) approved a Plan of Complete Liquidation and
Dissolution (the Plan of Dissolution) in September 2009, it was subject to approval by holders of
at least a majority in voting power of our outstanding shares. We called a special meeting of
stockholders to vote on the Plan of Dissolution, but the majority of our stockholders failed to
return their proxy cards or otherwise indicate their votes with respect to this proposal.
Accordingly, we were not able to obtain the requisite quorum to conduct business at the special
meeting and were therefore unable to proceed with dissolution.
Because we were unable to obtain sufficient stockholder votes to proceed with dissolution, we
entered into an Agreement and Plan of Reorganization (the Merger Agreement) by and among the
Company, Jewel Merger Sub, Inc. (Merger Sub) and Adamis Pharmaceuticals Corporation (Adamis) on
December 4, 2009. The transaction contemplated by the Merger Agreement was structured as a reverse
triangular merger, in which Merger Sub, a wholly-owned subsidiary of the Company, would merge with
and into Adamis, with Adamis surviving (the Merger). On March 3, 2010, the Company and Adamis
agreed to terminate the Merger Agreement as a result of too few of our stockholders voting on the
proposals related to the Merger such that we did not have the requisite quorum to hold the
stockholders meeting to approve the proposals related to the Merger. The solicitation of further
votes was cancelled due to the delisting from Nasdaq.
Effective at the open of business on March 4, 2010, the Companys common stock was suspended
and delisted from The NASDAQ Stock Market (Nasdaq) and began trading on The Pink OTC Markets,
Inc. The delisting was the result of Nasdaqs determination that the Company had nominal assets,
other than cash, and nominal operations.
In light of our inability to complete a strategic transaction that requires stockholder
approval, we are currently evaluating what options are available to us, which may include the
following:
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Sell or out-license our Riquent program, although we may not receive any
significant value upon such a sale or license; |
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Pursue potential other strategic transactions, which could include mergers,
license agreements or other collaborations, with third parties; or |
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Implement a wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company. |
Following the negative results of the ASPEN trial, we recorded a significant charge for the
impairment of our Riquent assets, including our Riquent-related patents, and we may not realize any
significant value from these assets in the future. Additionally, there is a substantial risk that
we may not successfully implement any of these strategic alternatives, and even if we determine to
pursue one or more of these alternatives, we may be unable to do so on acceptable terms. Any such
transactions may be highly dilutive to our existing stockholders and may deplete our limited
remaining capital resources.
In January 2009, we sold $10 million of face-value auction rate securities to our
broker-dealer, UBS A.G. (UBS). As of December 31, 2008, we had recognized a total
impairment charge of $2.3 million as a result of the illiquidity of these securities, which was
fully offset by a $2.3 million realized gain from UBSs repurchase
agreement that provides for a put option on these securities. Following the sale of these
investments, we no longer hold any auction-rate securities.
8
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on
our consolidated financial statements, which have been prepared in
accordance with GAAP. The preparation of these consolidated financial
statements requires us to make estimates and judgments that affect the reported amounts of assets,
liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. We
evaluate our estimates on an ongoing basis. We base our estimates on historical experience and on
other assumptions that we believe to be reasonable under the circumstances, the results of which
form the basis for making judgments about the carrying values of assets and liabilities that are
not readily apparent from other sources. Actual results may differ materially from these estimates
under different assumptions or conditions.
We believe the following critical accounting policies involve significant judgments and
estimates used in the preparation of our consolidated financial statements (see also Note 1 to our
consolidated financial statements included in Part IV).
Revenue recognition
We apply the revenue recognition criteria outlined in the ASC Topic of Revenue Recognition. Upfront product and
technology license fees under multiple-element arrangements are deferred and recognized over the period of such
services or performance if such arrangements require on-going services or performance. Non-refundable amounts received
for substantive milestones are recognized upon achievement of the milestone. Any amounts received prior to satisfying
our revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance sheets.
Our sole
source of revenue in the accompanying consolidated financial
statements related to a January 4, 2009 Development Agreement with BioMarin CF which contained
multiple potential revenue elements, including non-refundable upfront fees. The Development Agreement was terminated on
March 27, 2009 following the failure of the Phase 3 ASPEN trial at which time we had no remaining on-going services or
performance. We recognized $8.1 million as collaboration revenue upon termination of the Development Agreement.
Impairment of long-lived assets
If indicators of impairment exist, we assess the recoverability of the affected long-lived
assets by determining whether the carrying value of such assets can be recovered through the
undiscounted future operating cash flows.
As a result of the futility determination in the Phase 3 ASPEN trial, we discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. Based on these events, the future cash
flows from our Riquent-related patents were no longer expected to exceed their carrying values and
the assets became impaired as of December 31, 2008. Accordingly, we recorded a non-cash charge for
the impairment of long-lived assets of $2.8 million for the year ended December 31, 2008 to write
down the value of our long-lived assets to their estimated fair values. Although no impairment
charges were recorded during 2009, we sold, disposed of, or wrote off all of our remaining
long-lived assets during the year ended December 31, 2009 for a gain of $0.3 million.
Accrued clinical/regulatory expenses
As a result of the discontinuation of the Riquent Phase 3 ASPEN study and the development of
Riquent, all clinical and regulatory activities were ceased and no related accruals were required
as of December 31, 2009.
We reviewed and accrued clinical trial and regulatory-related expenses based on work
performed, which relied on estimates of total costs incurred based on patient enrollment,
completion of studies and other events. We followed this method since reasonably dependable
estimates of the costs applicable to various stages of a clinical trial could be made.
9
Share-based compensation
Share-based compensation expense for the years ended December 31, 2009 and 2008 was
approximately $2.7 million and $4.4 million, respectively. As of December 31, 2009, there was
approximately $1.0 million of total unrecognized compensation cost related to non-vested
share-based payment awards granted under all equity compensation plans. As share-based compensation
expense recognized for fiscal years 2009 and 2008 is based on awards ultimately expected to vest,
share-based compensation expense has been reduced for estimated forfeitures. Forfeitures are
estimated at the time of grant and revised, if necessary, in subsequent periods if actual
forfeitures differ from those estimates. Total unrecognized compensation cost will be adjusted for
future changes in estimated forfeitures. We expect to recognize that cost over a weighted-average
period of 0.8 years. Additional share-based compensation expense for any new share-based payment
awards granted after December 31, 2009 under all equity compensation plans cannot be predicted at
this time because it will depend on, among other matters, the amounts of share-based payment awards
granted in the future.
Option-pricing models were developed for use in estimating the value of traded options that
have no vesting or hedging restrictions and are fully transferable. Because the employee and
director stock options granted by us have characteristics that are significantly different from
traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in our opinion the existing valuation models may not provide an accurate measure
of the fair value of the employee and director stock options granted by us. Although the fair value
of the employee and director stock options granted by us using an option-pricing model, that value
may not be indicative of the fair value observed in a willing-buyer/willing-seller market
transaction.
New Accounting Pronouncements
In June 2009, the Financial Accounting Standards Board (FASB) approved the FASB Accounting
Standards Codification (the Codification) when it issued Statement of Financial Accounting
Standards No. 168, The FASB Accounting Standards Codification and the Hierarchy of Generally
Accepted Accounting Principles, which is included in The Accounting Standards Codification (ASC)
Topic of Generally Accepted Accounting Principles (the Topic). All existing accounting standard
documents, such as FASB, American Institute of Certified Public Accountants, Emerging Issues Task
Force and other related literature, excluding guidance from the Securities and Exchange Commission
(SEC), have been superseded by the Codification. All other non-grandfathered, non-SEC accounting
literature not included in the Codification has become non-authoritative. The Codification did not
change GAAP, but instead introduced a new structure that combines all authoritative standards into
a comprehensive, topically-organized online database. The Topic is effective for financial
statements issued for interim and annual periods ending after September 15, 2009. The Topic impacts
our financial statement disclosures as all future references to authoritative accounting literature
will be referenced in accordance with the Codification. As a result of the implementation of the
Codification during the quarter ended September 30, 2009, previous references to accounting
standards and literature are no longer applicable.
Results of Operations
Years Ended December 31, 2009 and 2008
Revenue. For the year ended December 31, 2009, revenue increased to $8.1 million as a result
of the Development Agreement entered into with BioMarin CF in January 2009. The Development
Agreement was terminated in March 2009 following the negative results from our Riquent Phase 3
ASPEN study. There were no revenues for the year ended December 31, 2008.
10
Expenses. During the year ended December 31, 2009, we negotiated settlements related to
accounts payable obligations and accrued liabilities with a majority of our vendors to preserve our
remaining cash and other
assets. These negotiations resulted in a reduction of approximately $2.7 million to accounts
payable obligations and accrued liabilities from amounts originally invoiced and accrued, which
were recorded upon the execution of the settlement agreements. As a result of these settlements,
during the year ended December 31, 2009, there were decreases of $2.6 million and $0.1 million to
research and development and general and administrative expenses, respectively.
Research and Development Expense. For the year ended December 31, 2009, research and
development expenses decreased to $9.6 million from $51.0 million for the year ended December 31,
2008 as a result of the discontinuation of the Riquent Phase 3 ASPEN study, salary and benefits
decreases due to the termination of all research personnel and the settlement of accounts payable
obligations and accrued liabilities noted above. This decrease was partially offset by an increase
in termination expense, mainly relating to severance, of approximately $0.7 million recorded as of
March 31, 2009, as a result of the termination of 64 research and development personnel in April
2009. We expect minimal research and development expenditures going forward.
General and Administrative Expense. For the year ended December 31, 2009, general and
administrative expenses decreased to $7.2 million from $9.7 million for the year ended December 31,
2008. The decrease in general and administrative expenses is primarily the result of decreases in
consulting and legal expense related to the BioMarin partnership for the year ended December 31,
2009 of $1.8 million. In addition, during April 2009, 10 general and administrative personnel were
terminated, resulting in salary and benefits decreases for the year ended December 31, 2009 of $0.8
million. The decrease in general and administrative expense for year ended December 31, 2009 was
partially offset by an increase in termination expense recorded as of March 31, 2009 relating to
severance of approximately $0.3 million as a result of the termination of personnel in April 2009
and retention payments recorded as of December 31, 2009 of $0.1 million related to our remaining
officers as of December 31, 2009. We expect decreased general and administrative expenditures going
forward.
Asset Impairments. We recorded a $2.8 million impairment charge in 2008 (none in 2009) because
we no longer believed that the estimated undiscounted future cash flows expected to result from the
disposition of certain of the Companys long-lived assets were sufficient to recover the carrying
value of these assets. This impairment charge was due to the negative results from the Riquent
Phase 3 ASPEN study announced in February 2009, which was an indicator of impairment.
Interest Expense, Interest and Other Income. Interest expense decreased for the year ended
December 31, 2009 compared to the prior year due to the repayment of our notes payable and capital
leases during the quarter ended June 30, 2009. Interest and other income decreased to less than
$0.1 million for the year ended December 31, 2009, from $0.8 million for the year ended December
31, 2008. This decrease is primarily due to moving all short-term investments to non-interest
bearing cash accounts during the quarter ended March 31, 2009.
Net Operating Loss and Research Tax Credit Carryforwards. At December 31, 2008, we had federal
and California income tax net operating loss carryforwards that are subject to Internal Revenue
Code, or IRC, Section 382/383 limitations of net operating loss and research and development credit
carryforwards. In February 2009, we experienced a change in ownership at a time when our
enterprise value was minimal. As a result of this ownership change and the low enterprise value,
our federal and California net operating loss carryforwards and federal research and development
credit carryforwards as of December 31, 2009 will be subject to limitation under IRC Section
382/383 and more likely than not will expire unused.
Liquidity and Capital Resources
From inception through December 31, 2009, we have incurred a cumulative net loss of
approximately $424.3 million and have financed our operations through public and private offerings
of securities, revenues from collaborative agreements, equipment financings and interest income on
invested cash balances. From inception through December 31, 2009, we had raised approximately
$410.8 million in net proceeds from sales of equity securities.
11
As of December 31, 2009, we had $4.3 million in cash, compared to $19.4 million in cash, cash
equivalents and short-term investments as of December 31, 2008. Our working capital as of December
31, 2009 was $4.2 million, as compared to $3.0 million as of December 31, 2008. The decrease in
cash, cash equivalents and short-term investments resulted from the use of our financial resources to fund our clinical trial
and manufacturing activities during early 2009 and for other general corporate purposes. This
decrease was partially offset by the non-refundable commencement payment of $7.5 million received
from BioMarin CF under the Development Agreement and the proceeds of $7.5 million from the sale of
339,104 shares of our preferred stock to BioMarin Pharma under the
concurrently executed Securities Purchase Agreement in
January 2009.
In January 2009, all of our auction rate securities were sold to UBS at par value of $10.0
million in accordance with the terms of the November 2008 redemption offer from UBS (see Note 2 to
our consolidated financial statements included in Part IV).
In January 2009, the amount outstanding on the credit facility with UBS of $5.9 million was
settled in full and the Credit Facility agreement with UBS was terminated.
On March 27, 2009 and as a result of the termination of the Development Agreement with
BioMarin CF, the Series B Preferred Stock issued to BioMarin Pharma converted into 10,173,120
shares of Common Stock.
On July 31, 2009, our two building leases expired. Pursuant to the lease for one of these
buildings, we were responsible for completing modifications to the leased building prior to lease
expiration. In July 2009, approximately $0.3 million was paid in accordance with the lease provisions.
We exited the buildings upon the expiration of the leases in July 2009.
During the year ended December 31, 2009, we paid off all remaining notes payable and capital
lease obligations. In addition, we early terminated our operating leases during the quarter ended
June 30, 2009. No notes payable, purchase commitments, capital leases or material operating leases
existed as of December 31, 2009.
We intend to use our financial resources to fund our current obligations and to pursue other
strategic alternatives that may become available to us. In the future, it is possible that we will
not have adequate resources to support continued operations and we will need to cease operations.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
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our ability to sell, out-license or otherwise dispose of our Riquent program; |
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our ability to consummate a strategic transaction such as a merger, license agreement
or other collaboration with a third party; or |
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our implementation of a wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company; |
There can be no assurance that we will be able to enter into any strategic transactions on
acceptable terms, if any, and our negotiating position may worsen as we continue to utilize our
existing resources.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current
or future effect on our consolidated financial condition, changes in our consolidated financial
condition, expenses, consolidated results of operations, liquidity, capital expenditures or capital
resources.
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Item 8. |
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Financial Statements and Supplementary Data. |
The financial
statements and supplementary data required by this item are set forth
under the caption Selected Quarterly Financial Data on page
F-21 and at the end of this report
beginning on page F-2 and is incorporated herein by reference.
12
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Item 9. |
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Changes in and Disagreements with Accountants on Accounting and Financial Disclosure. |
None.
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Item 9A(T). |
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Controls and Procedures. |
(a) Disclosure Controls and Procedures; Changes in Internal Control Over Financial Reporting
Our management, with the participation of our principal executive and principal financial
officers, has evaluated the effectiveness of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the Exchange
Act)) as of December 31, 2009. Based on this evaluation, our principal executive and principal
financial officers concluded that our disclosure controls and procedures were effective as of
December 31, 2009.
There was no change in our internal control over financial reporting during the quarter ended
December 31, 2009 that has materially affected, or is reasonably likely to materially affect, our
internal control over financial reporting.
(b) Management Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over
financial reporting. Internal control over financial reporting is defined in Rule 13a-15(f) and
Rule 15d-15(f) promulgated under the Exchange Act as a process designed by, or under the
supervision of, our principal executive and principal financial officers and effected by our board
of directors, management and other personnel, to provide reasonable assurance regarding the
reliability of financial reporting and the preparation of financial statements for external
purposes in accordance with generally accepted accounting principles and includes those policies
and procedures that:
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Pertain to the maintenance of records that in reasonable detail accurately and
fairly reflect the transactions and dispositions of our assets; |
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Provide reasonable assurance that transactions are recorded as necessary to permit
preparation of financial statements in accordance with generally accepted accounting
principles, and that receipts and expenditures are being made only in accordance with
authorizations of our management and directors; and |
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Provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have a material
effect on our financial statements. |
Because of its inherent limitations, internal control over financial reporting may not prevent
or detect misstatements. Projections of any evaluation of effectiveness to future periods are
subject to the risk that controls may become inadequate because of changes in conditions, or that
the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as
of December 31, 2009. In making this assessment, our management used the criteria set forth by the
Committee of Sponsoring Organizations of the Treadway Commission in Internal Control-Integrated
Framework.
Based on our assessment, management concluded that, as of December 31, 2009, our internal
control over financial reporting was effective based on those criteria.
This annual report does not include an attestation report of the Companys registered public
accounting firm regarding internal control over financial reporting. Managements report was not
subject to attestation by the Companys registered public accounting firm pursuant to temporary
rules of the Securities and Exchange Commission that permit the Company to provide only
managements report in this annual report.
13
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Item 9B. |
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Other Information. |
We called a special meeting of stockholders in October 2009 to vote on the Plan of
Dissolution. However, the majority of our stockholders failed to return their proxy cards or
otherwise indicate their votes with respect to this proposal. As a result, we were unable to
obtain the requisite quorum to conduct business at the special meeting and thus we cancelled the
special meeting in November 2009.
We called a special meeting of stockholders in February 2010 to vote on the Merger with
Adamis. However, the majority of our stockholders failed to return their proxy cards or otherwise
indicate their votes with respect to this proposal. As a result, we were unable to obtain the
requisite quorum to conduct business at the special meeting and thus we cancelled the special
meeting in March 2010.
14
PART III
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Item 10. |
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Directors, Executive Officers and Corporate Governance. |
Our directors and executive officers and their ages as of March 5, 2010 are set forth below.
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Name |
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Age |
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Position(s) |
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Craig R. Smith, M.D. |
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64 |
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Director, Chairman of the Board |
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Deirdre Y. Gillespie, M.D. |
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53 |
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President, Chief Executive Officer and Assistant Secretary |
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Gail A. Sloan, CPA |
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47 |
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Vice President of Finance and Secretary |
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Robert A. Fildes, Ph.D. |
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71 |
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Director |
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Stephen M. Martin |
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63 |
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Director |
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Frank E. Young, M.D., Ph.D. |
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78 |
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Director |
The biographies of our directors and executive officers appear below.
Craig R. Smith, M.D. has been a director since 2004 and Chairman of the Board since 2006. Dr.
Smith is currently Executive Vice President, Chief Operating Officer and director of Algenol
Biofuels Inc., a privately held industrial biotechnology company, and the President of Williston
Consulting, LLC, a consulting firm providing advisory services to pharmaceutical and biotechnology
companies. From 1993 to 2004, Dr. Smith served as Chairman, President and Chief Executive Officer
of Guilford Pharmaceuticals, Inc., a publicly held pharmaceutical company. From 1988 to 1992, Dr.
Smith was Vice President of Clinical Research and from 1992 to 1993, Senior Vice President of
Business and Market Development at Centocor, Inc., a publicly held biotechnology company, which is
now a wholly-owned subsidiary of Johnson & Johnson. From 1975 to 1988, he served on the faculty of
the Department of Medicine at the Johns Hopkins University School of Medicine. Dr. Smith is a
member of the Johns Hopkins Alliance for Science and a member of the board of directors of Adams
Express Company, a publicly held closed-end equity investment company, Petroleum & Resources
Corporation, a publicly held equity investment company specializing in energy and natural
resources, and Depomed, Inc., a publicly held specialty pharmaceutical company. Dr. Smith holds an
M.D. from the State University of New York at Buffalo and trained in Internal Medicine at the Johns
Hopkins Hospital from 1972 to 1975. Based on Dr. Smiths executive experience and service on other
boards of directors in the biotechnology and pharmaceutical industries, as well as his
experience in medicine and academia, the Board believes Dr. Smith has the appropriate set of skills
to serve as a member of our Board.
Deirdre Y. Gillespie, M.D., President, Chief Executive Officer and Assistant Secretary, joined
us in March 2006 as a director, and as President and Chief Executive Officer. She was appointed
Assistant Secretary in February 2007. Dr. Gillespie previously served as the President and Chief
Executive Officer of Oxxon Therapeutics, Inc., a privately held pharmaceutical company, from 2001
to 2005. Prior to that, she served as Chief Operating Officer of Vical, Inc., from 2000 to 2001,
and Executive Vice President & Chief Business Officer, from 1998 to 2000. Dr. Gillespie also held a
number of positions at DuPont Merck Pharmaceutical Company, including Vice President of Marketing,
from 1991 to 1996. Dr. Gillespie received her M.B.A. from the London Business School and her M.D.
and B.Sc. from London University.
Gail A. Sloan, CPA, Vice President of Finance and Secretary, joined us in 1996 as Assistant
Controller, was promoted to Controller in 1997, to Senior Director of Finance in 2002 and to Vice
President of Finance in 2004. She was appointed Secretary in 1999. Prior to joining us, from 1993
to 1996, Ms. Sloan served as Assistant Controller at Affymax Research Institute, a publicly held
drug-discovery research company and formerly a part of the Glaxo Wellcome Group. From 1985 to 1993,
she progressed to the position of Audit Manager with Ernst &
Young LLP. Ms. Sloan holds a B.S. in Business Administration from California Polytechnic State
University, San Luis Obispo and is a Certified Public Accountant.
15
Robert A. Fildes, Ph.D. has been a director since 1991. Since January 1998, Dr. Fildes has
served as President of SB2, Inc., a privately held company that licenses antibody technology. From
June to December 1998, Dr. Fildes served as Chief Executive Officer of Atlantic Pharmaceuticals, a
publicly held company in the field of biotechnology. From 1993 to 1997, Dr. Fildes was the
Chairman and Chief Executive Officer of Scotgen Biopharmaceuticals, Inc., a privately held company
in the field of human monoclonal antibody technology. From 1990 to 1993, Dr. Fildes was an
independent consultant in the biopharmaceutical industry. He was the president and Chief Executive
Officer of Cetus Corporation, a publicly held biotechnology company, from 1982 to 1990. From 1980
to 1982, Dr. Fildes was the President of Biogen, Inc., which merged with IDEC Pharmaceuticals
Corporation in 2003 to form Biogen Idec, a publicly held biopharmaceutical company, and from 1975
to 1980, he was the Vice President of Operations for the Industrial Division of Bristol-Myers
Squibb Company . From April 2002 to April 2003, Dr. Fildes was a director of Polymerat Pty. Ltd.,
a privately held company (now Anteo Diagnostics Ltd., a publicly held company) that develops
surfaces for carrying out biological reactions. Dr. Fildes is currently a director of Inimex
Pharmaceuticals, Inc., a privately held Canadian biotechnology company. Dr. Fildes holds a D.C.C.
degree in Microbial Biochemistry and a Ph.D. in Biochemical Genetics from the University of
London. Based on Dr. Fildes executive experience, specifically his experience as Chief
Executive Officer at numerous companies in the biotechnology industry, as well as his service on
other boards of directors in the biotechnology industries, the Board believes Dr. Fildes has the
appropriate set of skills to serve as a member of our Board.
Stephen M. Martin has been a director since April 2000. Mr. Martin is currently CEO Partner of Hi
Tech Partners, LLC, a privately held consulting firm for executive management of early stage
technology businesses. In April 2009, he joined QSpex Technologies, Inc., an early-stage private
Ophthalmic (Spectacle) Lens manufacturing company as Chief Business Officer and was promoted to
Chief Executive Officer in June 2009. In June 2001, Mr. Martin retired from CIBA Vision
Corporation, a Novartis Company engaged in the research, manufacture and sale of contact lenses,
lens care products and ophthalmic pharmaceuticals. Mr. Martin founded CIBA Vision in 1980. Mr.
Martin was President of CIBA Vision Corporation, USA from 1995 to 1998 and President of Ciba Vision
Ophthalmics, USA, the companys ophthalmic pharmaceutical division, which he founded, from 1990
until 1998. He served as CIBA Visions Vice President of Venture Opportunities from 1998 until his
retirement in 2001. Mr. Martin currently serves as a director of QSpex Technologies, Inc., a
privately held spectacle manufacturing company, OcuCure Therapeutics, Inc., a privately held
ophthalmic pharmaceutical development company and NeoVista, Inc., a privately held medical device
company. From 2003 to 2005, Mr. Martin served as a director of Alimera Sciences, Inc., a privately
held ophthalmic pharmaceutical company. Mr. Martin is the inventor on six issued U.S. patents and a
number of European patents. Mr. Martin holds a B.A. degree from Wake Forest University and attended
the Woodrow Wilson College of Law. Based on Mr. Martins executive experience, including
his experience in senior management positions in business development, as well as his service on
other boards of directors, the Board believes Mr. Martin has the appropriate set of skills to serve
as a member of our Board.
Frank E. Young, M.D., Ph.D. has been a director since 2005. Dr. Young is a former Commissioner of
the United States Food and Drug Administration (FDA) and has had over a 40-year career in
medicine, academia and government. After numerous academic appointments, Dr. Young served as
Chairman of the Department of Microbiology and Professor of Microbiology, of Pathology, and of
Radiation Biology and Biophysics at the University of Rochester, New York. Subsequently, he became
Dean of the School of Medicine and Dentistry, Director of the Medical Center and Vice President for
Health Affairs at the University of Rochester. Dr. Young joined the Department of Health and Human
Services as Commissioner of the FDA and Assistant Surgeon General (Rear Admiral, USPHS) in 1984.
Under Presidents Ronald Reagan, George H.W. Bush, and William J. Clinton, Dr. Young served as
Commissioner of the FDA, Deputy Assistant Secretary and Director of the Office of Emergency
Preparedness, Director of the National Disaster Medical System and as a member of the Executive
Board of the World Health Organization (presidential appointee). Dr. Young currently serves as the
Chief Executive Officer of Cosmos Alliance and is a partner of Essex Woodlands Health Ventures. In
addition, Dr. Young is Vice Chairman of the board of Agennix AG,
a publicly traded company, and serves on the boards of the following
private companies: Elusys Therapeutics, Inc. and Light Sciences
Oncology. Dr. Young attended Union College and holds an M.D. degree from the
University of the State of New York, Upstate Medical Center, where he graduated cum laude, and a
Ph.D. degree from Case Western Reserve University. Based on Dr. Youngs experience as a
Commissioner of the FDA, his experience in medicine and academia, and his service on other boards
of directors in the biotechnology industry, the Board believes Dr. Young has the appropriate set of
skills to serve as a member of our Board.
16
Director Independence
Our Board has previously determined that each of Doctors Fildes, Smith and Young, and Mr.
Martin are independent within the meaning of Nasdaq Marketplace Rules 5605(b) and 5605(a)(2) as
adopted by the Nasdaq Stock Market, Inc. (Nasdaq). Dr. Gillespie was not deemed to be
independent because she is our President and Chief Executive Officer.
Committees of the Board of Directors
Our Board has three standing committees: an audit committee; a compensation committee; and a
corporate governance and nominating committee. As discussed above, all committee members have been
previously determined by our Board to be independent. The committees operate under written
charters that are available for viewing on our website at
www.ljpc.com, then Investor Relations.
Audit Committee. It is the responsibility of the audit committee to oversee our accounting and
financial reporting processes and the audits of our financial statements. In addition, the audit
committee assists the Board in its oversight of our compliance with legal and regulatory
requirements. The specific duties of the audit committee include: monitoring the integrity of our
financial process and systems of internal controls regarding finance, accounting and legal
compliance; selecting our independent auditor; monitoring the independence and performance of our
independent auditor; and providing an avenue of communication among the independent auditor, our
management and our Board. The audit committee has the authority to conduct any investigation
appropriate to fulfill its responsibilities, and it has direct access to all of our employees and
to the independent auditor. The audit committee also has the ability to retain, at our expense and
without further approval of the Board, special legal, accounting or other consultants or experts
that it deems necessary in the performance of its duties.
The audit committee met five times during 2009, and otherwise accomplished its business
without formal meetings. The members of the audit committee are Mr. Martin and Doctors Fildes and
Smith. Mr. Martin currently serves as the chairman of the audit committee. Our Board has previously
determined that each of Doctors Fildes and Smith and Mr. Martin is independent within the meaning
of the enhanced independence standards contained in Nasdaq Marketplace Rule 5605(c)(2)(A) and Rule
10A-3 under the Exchange Act that relate specifically to members of audit committees.
Our Board has also previously determined that Dr. Smith has sufficient relevant attributes to
be deemed the audit committees audit committee financial expert as defined in Item 407 of
Regulation S-K.
Compensation Committee. It is the responsibility of the compensation committee to assist the
Board in discharging the Board of Directors responsibilities regarding the compensation of our
employees and directors. The specific duties of the compensation committee include: making
recommendations to the Board regarding the corporate goals and objectives relevant to executive
compensation; evaluating our executive officers performance in light of such goals and objectives;
recommending compensation levels to the Board based upon such evaluations; administering our
incentive compensation plans, including our equity-based incentive plans; making recommendations to
the Board regarding our overall compensation structure, policies and programs; and reviewing the
Companys compensation disclosures. Additional information regarding the processes and procedures
of the compensation committee is provided in Item 11 Executive Compensation.
The compensation committee met three times during 2009, and otherwise accomplished its
business without formal meetings. The members of the compensation committee through September 3,
2009 were Doctors Fildes, Adams and Topper, and Mr. Martin. After the resignations of Doctors Adams
and Topper on September 3, 2009, the compensation committee was comprised of Dr. Fildes and Mr.
Martin. Dr. Fildes currently serves as the chairman of the compensation committee.
17
Corporate Governance and Nominating Committee. It is the responsibility of the corporate
governance and nominating committee to assist the Board: to identify qualified individuals to
become Board members; to determine the composition of the Board and its committees; and to monitor
and assess the effectiveness of the Board and its committees. The specific duties of the corporate
governance and nominating committee include: identifying, screening and recommending to the Board
candidates for election to the Board; reviewing director candidates recommended by our
stockholders; assisting in attracting qualified director candidates to serve on the Board;
monitoring the independence of current directors and nominees; and monitoring and assessing the
relationship between the Board and our management with respect to the Boards ability to function
independently of management.
The corporate governance and nominating committee did not meet during 2009, but accomplished
its business without formal meetings. The members of the corporate governance and nominating
committee through September 3, 2009 were Doctors Young and Topper and Mr. Sutter. After the
resignations of Dr. Topper and Mr. Sutter on September 3, 2009, the corporate governance and
nominating committee was comprised of Dr. Young,
Meetings of Non-Management Directors. The non-management members of the Board regularly meet
without any members of management present during regularly scheduled executive sessions of meetings
of the Board.
Section 16(a) Beneficial Ownership Reporting Compliance
Under the securities laws of the United States, our directors and officers and persons who own
more than 10% of our equity securities are required to report their initial ownership of our equity
securities and any subsequent changes in that ownership to the Securities and Exchange Commission
and the Nasdaq Capital Market. Specific due dates for these reports have been established, and we
are required to disclose any late filings during the fiscal year ended December 31, 2009. To our
knowledge, based solely upon our review of the copies of such reports required to be furnished to
us during the fiscal year ended December 31, 2009, all of these reports were timely filed, except
one report filed in March 2009 by former named executive officer Josefina Elchico reporting the
sale of common stock that occurred during February 2009.
Code of Conduct
We have adopted a code of conduct that describes the ethical and legal responsibilities of all
of our employees and, to the extent applicable, members of our Board. This code includes (but is
not limited to) the requirements of the Sarbanes-Oxley Act of 2002 pertaining to codes of ethics
for chief executives and senior financial and accounting officers. Our Board has reviewed and
approved this code. Our employees agree in writing to comply with the code at commencement of
employment and periodically thereafter. Our employees are encouraged to report suspected violations
of the code. Our code of conduct is available for viewing on our website at www.ljpc.com, then
Investor Relations. If we make substantive
amendments to the code or grant any waiver, including any implicit waiver, to our principal
executive, financial or accounting officer, or persons performing similar functions, we will
disclose the nature of such amendment or waiver on our website and/or in a report on Form 8-K in
accordance with applicable rules and regulations.
|
|
|
Item 11. |
|
Executive Compensation. |
Equity Compensation. Under the 2004 Equity Incentive Plan, the Compensation Committee may
grant stock options, restricted stock, stock appreciation rights and performance awards. In
granting these awards, the Committee may establish any conditions or restrictions it deems
appropriate. The grant of options is unrelated to any anticipated major announcements made by the
Company and is thus not influenced by any material, non-public information that may exist at the
time of grant.
The exercise price of stock options is set at the fair market value on the grant date using
the closing market price on the date of grant. New hire stock option awards granted in 2009 vest
with respect to 25% of the underlying shares on the one-year anniversary from the date of grant and
with respect to the remaining 75% of the underlying
shares on a monthly pro rata basis over the next three years. Stock option awards granted in
2009 as a part of the annual performance review process vest monthly on a pro rata basis over 4
years.
18
The annual stock option awards for executive performance in fiscal 2008 were made on January
22, 2009. No annual stock option awards for executive performance in fiscal 2009 were made.
On
December 31, 2009, we granted 2,021,024 restricted stock units (RSUs) to our
three remaining employees where each RSU represents a contingent right to receive one
share of the Companys common stock. The RSUs vest upon the closing of the Merger, subject to the
continued employment of the recipient through the closing date of the
Merger. The RSUs were valued
at the fair market value of the Companys common stock on the grant date. The value of the RSUs on
December 31, 2009 was $344,000 and no compensation expense for these RSUs was recognized during
2009. The RSUs were cancelled in March 2010 as a result of the termination of the Merger in March
2010.
Benefits. Our 1995 Employee Stock Purchase Plan (the 1995 Plan) provides
employees with an opportunity to acquire increased equity ownership in the Company over time
through periodic purchases of shares. Our 1995 Plan allows employees, including the Named
Executive Officers, to purchase common stock every three months (in an amount not exceeding 10% of
each employees base salary, or hourly compensation, and any cash bonus paid, subject to certain
limitations) over the offering period at 85% of the fair market value of the common stock at
specified dates. The offering period may not exceed 24 months. No purchases under the 1995 Plan
occurred during 2009.
Our retirement savings plan (401(k) Plan) was terminated in March 2009. Prior to
its termination, our retirement savings plan was a tax-qualified
retirement savings plan, pursuant to which all employees, including the Named Executive Officers,
were able to contribute the lesser of 50% of their annual compensation or the limit prescribed by
the Internal Revenue Service to the 401(k) Plan on a before-tax basis. We did not match
employee contributions or otherwise contribute to the 401(k) Plan.
Our health and welfare programs were terminated in April 2009.
We have not historically provided special benefits or perquisites to our executives
and did not do so in 2009.
Retention and Separation Agreements.
On December 4, 2009, we entered into Retention and Separation Agreements and General Release
of All Claims (the Retention Agreements) with our current Named Executive Officers. Our current
Named Executive Officers are our Chief Executive Officer and our Vice President of Finance. The
Retention Agreements supersede the severance provisions of the employment agreements with the
current Named Executive Officers that were effective prior to the signing of the Retention
Agreements (the Prior Employment Agreements), but otherwise the terms of the Prior Employment
Agreements remain in full force and effect. The Retention Agreements do not alter the amount of
severance that was to be awarded under the Prior Employment Agreements, but rather change the
events that trigger such payments.
Pursuant to the Retention Agreements, on December 18, 2009 we made retention payments to the
current Named Executive Officers (the Retention Payments) in the amounts of $202,800 to our Chief
Executive Officer and $66,184 to our Vice President of Finance. If the current Named Executive
Officers voluntarily resigned their employment prior to the earlier to occur of (a) the closing of
the Merger or (b) March 31, 2010, they were to immediately repay the Retention Payments to us. The
date under (a) and (b) shall be referred to as the Separation Date.
Under the Retention Agreements, each of the current Named Executive Officers agreed to execute
an amendment to the Retention Agreements (the Amendment) on or about the Separation Date to
extend and reaffirm the promises and covenants made by them in the Retention Agreements through the
Separation Date. The Retention Agreements also provided for severance
payments to the Named Executive Officers (Severance Payments) payable in a lump sum on the eighth day after the current Named Executive Officers signed the
Amendment.
19
In
April 2010, the Compensation Committee confirmed that pursuant
to the terms of the Retention Agreements, the Retention Payments and
Severance Payments were earned as of March 31, 2010 and agreed
that the existing employment terms would remain in
effect beyond March 31, 2010. As
an incentive to retain the current Named Executive Officers to pursue a strategic transaction such
as a merger, license agreement, third party collaboration or wind
down of the Company, the Compensation Committee also
approved a retention bonus for a total of up to approximately $600,000, depending on the type of strategic
transaction completed.
In addition to the provisions of the Retention Agreements described above, effective
information regarding applicable payments under the Prior Employment Agreements for the current
Named Executive Officers is provided below.
Deirdre Y. Gillespie, M.D. Dr. Gillespie is entitled to (i) an annual base salary of $375,000
(which amount has increased since her commencement of employment with us such that her current
annual base salary is $405,600); (ii) a discretionary annual bonus with a target amount equal to
40% of her annual base salary (this target percentage has been increased to 50% as of December 31,
2008, although the exact amount will be determined each year based on Dr. Gillespies and the
Companys performance with respect to performance objectives established by the compensation
committee); and (iii) a grant of an option to purchase 800,000 shares of common stock of the
Company, with the option vesting with respect to 200,000 of the underlying shares on the first
anniversary of the date of the agreement and 1/36th of the remaining option to purchase 600,000
shares vesting each month thereafter. The agreements contain non-competition and non-interference
provisions; and all post-employment benefits are in exchange for a release agreement. If (i) the
Company terminates Dr. Gillespie for cause, all options held by her, whether or not vested, will
immediately terminate and become unexercisable (ii) Dr. Gillespie voluntarily resigns, all unvested
options held by her will immediately terminate and become unexercisable and all vested options will
remain exercisable until three months after the date of termination in the case of incentive stock
options or six months in the case of non-qualified stock options, (iii) Dr. Gillespies employment
ceases as a result of her death or disability, then all unvested options held by her will
immediately terminate and become unexercisable and all vested options will remain exercisable until
the one year anniversary of the date of cessation of service; (iv) the Company terminates her
employment without cause or if she terminates her employment due to a constructive termination,
then: (a) one-half of all of her then unvested options will immediately vest and become
exercisable; (b) the other one-half of her then unvested options will immediately terminate and
become unexercisable; and (c) all vested options (including those which vested pursuant to clause
(a) shall expire on the two-year anniversary of the termination date; (v) Dr. Gillespies position
is reduced such that she no longer serves as CEO of the company on or within 360 days after the
consummation of a change in control, then all of her unvested options shall immediately vest and
become exercisable; and (vi) notwithstanding the foregoing, in no event shall any option be
exercisable after the date of expiration set forth in the Plan.
Gail A. Sloan Ms. Sloan is entitled to an annual base salary of $198,551 and a discretionary
annual bonus in a target amount equal to 30% of her base salary. Ms. Sloan is also eligible to
receive periodic equity awards under the Companys equity compensation plans. Ms. Sloans
employment will be deemed to be terminated in connection with a change in control if, within 180
days of the date of the change in control: (i) her employment is terminated; (ii) her position is
eliminated as a result of a reduction in force made to reduce over-capacity or unnecessary
duplication of personnel and she is not offered a replacement position with the Company or its
successor as a vice president with compensation and functional duties substantially similar to the
compensation and duties in effect immediately before the change in control; or (iii) she resigns
because she is required to be employed more than 50 miles from our current headquarters. Also, all
employee stock options granted to Ms. Sloan prior to her termination date will automatically vest
and become fully exercisable as of her termination date if her termination of employment is without
cause or is in connection with a change in control, and will remain exercisable for a period of one
year from her termination date or such longer period as provided by the applicable plan or grant
pursuant to which the options were granted.
20
Summary Compensation Table
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
Option |
|
|
Incentive Plan |
|
|
All Other |
|
|
|
|
Name and |
|
|
|
|
|
Salary |
|
|
|
|
|
|
Awards |
|
|
Awards |
|
|
Compensation |
|
|
Compensation |
|
|
Total |
|
Principal Position |
|
Year |
|
|
($) |
|
|
Bonus ($) (1) |
|
|
($) |
|
|
($) (2) |
|
|
($) (3) |
|
|
($) |
|
|
($) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Officers
Deirdre Y. Gillespie, M.D.
|
|
|
2009 |
|
|
$ |
421,200 |
|
|
$ |
202,800 |
|
|
$ |
|
|
|
$ |
1,167,161 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
1,791,161 |
|
President,
Chief Executive Officer and Assistant Secretary |
|
|
2008 |
|
|
|
402,600 |
|
|
|
|
|
|
|
|
|
|
|
1,093,763 |
|
|
|
200,772 |
|
|
|
|
|
|
|
1,697,135 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gail A. Sloan
|
|
|
2009 |
|
|
|
206,187 |
|
|
|
66,184 |
|
|
|
|
|
|
|
71,785 |
|
|
|
|
|
|
|
|
|
|
|
344,156 |
|
Vice President
of Finance and Secretary |
|
|
2008 |
|
|
|
196,906 |
|
|
|
|
|
|
|
|
|
|
|
307,483 |
|
|
|
53,609 |
|
|
|
|
|
|
|
557,998 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Former Officers*
Niv E. Caviar
|
|
|
2009 |
|
|
|
124,734 |
|
|
|
211,612 |
|
|
|
|
|
|
|
635,453 |
|
|
|
|
|
|
|
|
|
|
|
971,799 |
|
Executive Vice
President, Chief Business and Financial Officer |
|
|
2008 |
|
|
|
280,775 |
|
|
|
|
|
|
|
|
|
|
|
226,995 |
|
|
|
111,097 |
|
|
|
25,000 |
(4) |
|
|
643,867 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Michael Tansey, M.D., Ph.D.
|
|
|
2009 |
|
|
|
113,402 |
|
|
|
251,063 |
|
|
|
|
|
|
|
572,250 |
|
|
|
|
|
|
|
|
|
|
|
936,715 |
|
Executive Vice
President and Chief Medical Officer |
|
|
2008 |
|
|
|
332,875 |
|
|
|
|
|
|
|
|
|
|
|
387,029 |
|
|
|
90,383 |
|
|
|
|
|
|
|
810,287 |
|
|
|
|
* |
|
These former officers were terminated on April 20, 2009 as part of the Companys
restructuring activities, as described above. |
|
(1) |
|
The amounts for Dr. Gillespie and Ms. Sloan are retention payments made on December 18, 2009
in accordance with the Retention Agreements dated December 4, 2009. See Note 6 to our audited
consolidated financial statements. The amount for Mr. Caviar is severance equal to nine months
of Mr. Caviars annual base salary at December 31, 2008 pursuant to his employment agreement
dated May 10, 2007. The amount for Dr. Tansey is severance equal to nine months of Dr.
Tanseys annual base salary at December 31, 2008 pursuant to his employment agreement dated
December 4, 2006. These severance payments were made to Mr. Caviar and Dr. Tansey following
their respective terminations on April 20, 2009. |
|
(2) |
|
The amounts in this column reflect the dollar amount recognized for financial statement
reporting purposes for the fiscal years ended December 31, 2009 and December 31, 2008, for
awards and thus may include amounts from awards granted in and prior to 2008. Assumptions used
in the calculation of these amounts are included in Note 1 to our audited consolidated
financial statements. |
|
(3) |
|
These amounts represent the 2008 performance-based bonus awards which were paid in fiscal
year 2009. |
|
(4) |
|
This amount represents a signing bonus paid to Mr. Caviar in January 2008 in accordance with
his employment agreement. |
21
Outstanding Equity Awards at 2009 Fiscal Year End
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Market or |
|
|
|
Number of |
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payout Value of |
|
|
|
Securities |
|
|
Securities |
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
Unearned |
|
|
|
Underlying |
|
|
Underlying |
|
|
|
|
|
|
|
|
|
|
Unearned Shares, |
|
|
Shares, Units or |
|
|
|
Unexercised |
|
|
Unexercised |
|
|
Option |
|
|
|
|
|
|
Units or Other |
|
|
Other Rights |
|
|
|
Options |
|
|
Options |
|
|
Exercise |
|
|
Option |
|
|
Rights that have not |
|
|
that have not |
|
|
|
(#) |
|
|
(#) |
|
|
Price |
|
|
Expiration |
|
|
Vested |
|
|
Vested |
|
Name |
|
Exercisable |
|
|
Unexercisable |
|
|
($) |
|
|
Date(1) |
|
|
(#) |
|
|
($) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current Officers
Deirdre Y. Gillespie |
|
|
766,666 |
|
|
|
33,333 |
(2) |
|
$ |
5.26 |
|
|
|
03/15/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
106,250 |
|
|
|
43,750 |
(2) |
|
|
3.08 |
|
|
|
02/05/2017 |
|
|
|
|
|
|
|
|
|
|
|
|
68,750 |
|
|
|
81,250 |
(2) |
|
|
2.42 |
|
|
|
02/21/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
34,375 |
|
|
|
115,625 |
(2) |
|
|
1.42 |
|
|
|
01/22/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
1,411,898 |
(3) |
|
$ |
240,023 |
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gail A. Sloan |
|
|
972 |
|
|
|
|
|
|
|
18.44 |
|
|
|
01/28/2010 |
|
|
|
|
|
|
|
|
|
|
|
|
3,800 |
|
|
|
|
|
|
|
35.00 |
|
|
|
11/20/2010 |
|
|
|
|
|
|
|
|
|
|
|
|
3,000 |
|
|
|
|
|
|
|
38.25 |
|
|
|
07/19/2011 |
|
|
|
|
|
|
|
|
|
|
|
|
2,999 |
|
|
|
|
|
|
|
35.50 |
|
|
|
12/14/2011 |
|
|
|
|
|
|
|
|
|
|
|
|
5,999 |
|
|
|
|
|
|
|
25.45 |
|
|
|
07/18/2012 |
|
|
|
|
|
|
|
|
|
|
|
|
5,999 |
|
|
|
|
|
|
|
29.50 |
|
|
|
11/21/2012 |
|
|
|
|
|
|
|
|
|
|
|
|
5,999 |
|
|
|
|
|
|
|
14.85 |
|
|
|
05/12/2013 |
|
|
|
|
|
|
|
|
|
|
|
|
6,000 |
|
|
|
|
|
|
|
23.55 |
|
|
|
09/18/2013 |
|
|
|
|
|
|
|
|
|
|
|
|
14,000 |
|
|
|
|
|
|
|
14.80 |
|
|
|
05/21/2014 |
|
|
|
|
|
|
|
|
|
|
|
|
10,583 |
|
|
|
|
|
|
|
2.40 |
|
|
|
04/25/2015 |
|
|
|
|
|
|
|
|
|
|
|
|
5,415 |
|
|
|
|
|
|
|
2.15 |
|
|
|
05/19/2015 |
|
|
|
|
|
|
|
|
|
|
|
|
21,199 |
|
|
|
|
|
|
|
4.20 |
|
|
|
10/10/2015 |
|
|
|
|
|
|
|
|
|
|
|
|
184,548 |
|
|
|
|
|
|
|
4.46 |
|
|
|
04/17/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
17,708 |
|
|
|
7,291 |
(2) |
|
|
3.08 |
|
|
|
02/05/2017 |
|
|
|
|
|
|
|
|
|
|
|
|
11,458 |
|
|
|
13,541 |
(2) |
|
|
2.42 |
|
|
|
02/21/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
5,729 |
|
|
|
19,270 |
(2) |
|
|
1.42 |
|
|
|
01/22/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
483,810 |
(3) |
|
$ |
82,248 |
(4) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Former Officer*
Michael J.B. Tansey |
|
|
113,000 |
(5) |
|
|
|
|
|
|
3.61 |
|
|
|
07/17/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
87,000 |
(5) |
|
|
|
|
|
|
3.23 |
|
|
|
12/04/2016 |
|
|
|
|
|
|
|
|
|
|
|
|
50,000 |
(5) |
|
|
|
|
|
|
5.47 |
|
|
|
05/23/2017 |
|
|
|
|
|
|
|
|
|
|
|
|
40,000 |
(5) |
|
|
|
|
|
|
2.42 |
|
|
|
02/21/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
200,000 |
(5) |
|
|
|
|
|
|
1.82 |
|
|
|
05/22/2018 |
|
|
|
|
|
|
|
|
|
|
|
|
45,000 |
(5) |
|
|
|
|
|
|
1.42 |
|
|
|
01/22/2019 |
|
|
|
|
|
|
|
|
|
|
|
|
* |
|
This former officer was terminated on April 20, 2009. |
|
(1) |
|
All stock options expire ten years from the date of grant. |
|
(2) |
|
The stock options vest and become exercisable ratably on a monthly basis over four years from
the date of grant. |
|
(3) |
|
These are restricted stock units (RSUs) granted on December 31, 2009 where each RSU
represents a contingent right to receive one share of our common stock. The RSUs were to vest
upon the closing of the Merger, subject to the continued employment of the recipient through
the closing date of the Merger; however, the Merger was terminated in March 2010 and
accordingly, the RSUs were accordingly cancelled. |
|
(4) |
|
The value of each RSU is the closing price of our common stock on the date of grant, which
was $0.17. |
|
(5) |
|
Pursuant to Dr. Tanseys employment agreement dated December 4, 2006, all of Dr. Tanseys
unvested options automatically vested upon his termination date of April 20, 2009 and remain
exercisable for one year following the termination date. If not exercised by April 20, 2010,
all of Dr. Tanseys stock options will be cancelled on April 20, 2010. |
Option Exercises and Stock Vested in Fiscal Year 2009
No named executive officers exercised any options or had any restricted stock vest in fiscal
year 2009.
22
Director Compensation Table 2009
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fees Earned or |
|
|
|
|
|
|
|
|
|
|
|
|
Paid in Cash |
|
|
Stock Awards |
|
|
Option Awards |
|
|
Total |
|
Name |
|
($) |
|
|
($) |
|
|
($) (1) |
|
|
($) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thomas H. Adams (2) |
|
$ |
24,500 |
|
|
$ |
|
|
|
$ |
19,139 |
|
|
$ |
43,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Robert A. Fildes |
|
|
37,500 |
|
|
|
|
|
|
|
19,139 |
|
|
|
56,639 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stephen M. Martin |
|
|
51,000 |
|
|
|
|
|
|
|
19,139 |
|
|
|
70,139 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Craig R. Smith |
|
|
62,750 |
|
|
|
|
|
|
|
18,619 |
|
|
|
81,369 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Martin P. Sutter (2) |
|
|
|
|
|
|
|
|
|
|
6,206 |
|
|
|
6,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
James N. Topper (2) |
|
|
|
|
|
|
|
|
|
|
6,206 |
|
|
|
6,206 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Frank E. Young |
|
|
29,500 |
|
|
|
|
|
|
|
6,206 |
|
|
|
35,706 |
|
|
|
|
(1) |
|
The amounts in this column reflect the dollar amount recognized for financial statement
reporting purposes for the fiscal year ended December 31, 2009, and thus may include amounts
from awards granted in and prior to
2009. Assumptions used in the calculation of these amounts are included in Note 1 to our consolidated financial statements. |
|
(2) |
|
Doctors Adams and Topper and Mr. Sutter resigned as directors effective September 3, 2009. |
Director Compensation
Retainers and Fees. Directors who are also our employees receive no extra compensation for
their service on the Board. In 2009, non-employee directors received $1,500 per Board meeting
attended in person and $750 per Board meeting attended telephonically. Non-employee directors also
receive $750 per committee meeting attended in person and $500 per committee meeting attended
telephonically. Directors are reimbursed for reasonable costs associated with attendance at
meetings of the Board and its committees. Non-employee directors receive an annual retainer of
$20,000, which is paid quarterly. The Chairman of the Board, Dr. Smith, receives an additional
annual retainer of $25,000, which is paid quarterly. In 2009, the chairman of the audit committee
received an annual fee of $10,000. In 2009, the chairman of the compensation committee received an
annual fee of $5,000. All chairman fees are paid quarterly. All other members of the audit,
compensation and corporate governance and nominating committees receive an annual retainer of
$2,000, which is paid quarterly.
Option Grants Under the 2004 Plan. Under the La Jolla Pharmaceutical Company 2004 Equity
Incentive Plan, each of our non-employee directors automatically receives, upon becoming a
non-employee director, a one-time grant of a non-qualified stock option to purchase up to 40,000
shares of our common stock at an exercise price equal to the fair market value of a share of the
common stock on the date of grant. These non-employee director options have a term of 10 years and
vest with respect to 25% of the underlying shares on the grant date and with respect to an
additional 25% of the underlying shares on the date of each of the first three anniversaries of
such grant, but only if the director remains a non-employee director for the entire period from the
date of grant to such date. Upon re-election to our Board or upon continuing as a director after an
annual meeting without being re-elected due to the classification of the Board, each non-employee
director automatically receives a grant of an additional non-qualified stock option to purchase up
to 10,000 shares of our common stock. Due to the futility of the Riquent trial, the annual grants
for 2009 were not made. These additional non-employee director options have a term of 10 years and
vest and become exercisable upon the earlier to occur of the first anniversary of the grant date or
immediately prior to the annual meeting of stockholders next following the grant date; provided
that the director remains a director for the entire period from the grant date to such earlier
date. The exercise price for these additional non-employee director options is the fair market
value of our common stock on the date of their grant. All outstanding non-employee director options
vest in full immediately prior to any change in control. Each non-employee director is also
eligible to receive additional options under the 2004 Plan in the discretion of the compensation
committee of the Board. These options vest and become exercisable pursuant to the 2004 Plan and the
terms of the option grant. The Chairman of the Board receives an additional annual grant of
non-qualified stock options to purchase 20,000 shares of our common stock. Due to the futility of
the Riquent trial, this Chairman of the Board annual grant for 2009 was not made. These
non-employee director options have a term of 10 years and vest and become exercisable upon the
first anniversary of the grant date.
23
|
|
|
Item 12. |
|
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder
Matters. |
Equity Compensation Plan Information
The following table provides information as of December 31, 2009 with respect to shares of our
common stock that may be issued under our equity compensation plans.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Number of |
|
|
|
|
|
|
|
|
|
|
|
Securities |
|
|
|
|
|
|
|
|
|
|
|
Remaining |
|
|
|
|
|
|
|
|
|
|
|
Available for |
|
|
|
Number of |
|
|
|
|
|
|
Future Issuance |
|
|
|
Securities to be |
|
|
Weighted- |
|
|
Under Equity |
|
|
|
Issued upon |
|
|
Average Exercise |
|
|
Compensation |
|
|
|
Exercise of |
|
|
Price of |
|
|
Plans (Excluding |
|
|
|
Outstanding |
|
|
Outstanding |
|
|
Securities |
|
|
|
Options, Warrants |
|
|
Options, Warrants |
|
|
Reflected in |
|
|
|
and Rights |
|
|
and Rights |
|
|
Column (a)) |
|
Plan Category |
|
|
|
|
|
|
|
|
|
|
|
|
Equity Compensation plans approved by security holders |
|
|
5,529,591 |
(1) |
|
$ |
6.99 |
|
|
|
1,082,671 |
(2) |
Equity Compensation plans not approved by security holders |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(1) |
|
Outstanding options to purchase shares of our common stock under the La Jolla
Pharmaceutical Company 1994 Stock Incentive Plan and the 2004 Plan. |
|
(2) |
|
Includes 1,065,694 shares subject to the 2004 Plan and 16,977 shares subject to the
1995 Plan (each stated as of December 31, 2009). |
Security Ownership of Certain Beneficial Owners and Management
The following table sets forth information regarding beneficial ownership of our common stock
as of March 5, 2010 based on information available to us and filings with the SEC by:
|
|
|
each of our directors; |
|
|
|
|
each of our named executive officers as defined by SEC rules; |
|
|
|
|
all of our current directors and executive officers as a group; and |
|
|
|
|
each person or group of affiliated persons known by us to be the
beneficial owner of more than 5% of our common stock. |
24
Beneficial ownership and percentage ownership are determined in accordance with the rules
of the SEC and include voting or investment power with respect to shares of stock. This information
does not necessarily indicate beneficial ownership for any other purpose. Under these rules, shares
of our common stock issuable under stock options that are exercisable within 60 days of March 5,
2010 are deemed outstanding for the purpose of computing the percentage ownership of the person
holding the options, but are not deemed outstanding for the purpose of computing the percentage
ownership of any other person.
Unless otherwise indicated and subject to applicable community property laws, to our
knowledge, each stockholder named in the following table possesses sole voting and investment power
over their shares of our common stock, except for those jointly owned with that persons spouse.
Percentage of beneficial ownership of our common stock is based on 65,722,648 shares of common
stock outstanding as of March 5, 2010. Unless otherwise noted below, the address of each person
listed on the table is c/o La Jolla Pharmaceutical Company, 4365 Executive Drive, Suite 300, San
Diego, California 92121.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
|
|
|
|
|
|
|
|
Shares of |
|
|
with Right to |
|
|
|
|
|
|
|
|
|
Common |
|
|
Acquire |
|
|
Total |
|
|
Percentage |
|
|
|
Stock |
|
|
within 60 |
|
|
Beneficial |
|
|
of Common |
|
Name and Address |
|
Owned |
|
|
Days |
|
|
Ownership |
|
|
Stock |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Essex Woodlands Health Ventures Fund VI, L.P. and affiliates |
|
|
|
|
|
|
4,139,014 |
|
|
|
4,139,014 |
|
|
|
5.9 |
% |
Craig R. Smith, M.D.(1) |
|
|
|
|
|
|
123,400 |
|
|
|
123,400 |
|
|
|
* |
% |
Robert A. Fildes, Ph.D.(1) |
|
|
|
|
|
|
97,759 |
|
|
|
97,759 |
|
|
|
* |
% |
Stephen M. Martin(1) |
|
|
40 |
|
|
|
105,400 |
|
|
|
105,440 |
|
|
|
* |
% |
Frank E. Young, M.D., Ph.D.(1) |
|
|
5,600 |
|
|
|
38,000 |
|
|
|
43,600 |
|
|
|
* |
% |
Deirdre Y. Gillespie, M.D.(1)(2) |
|
|
|
|
|
|
1,046,875 |
|
|
|
1,046,875 |
|
|
|
1.6 |
% |
Gail A. Sloan(2) |
|
|
|
|
|
|
310,686 |
|
|
|
310,686 |
|
|
|
* |
% |
Michael J.B. Tansey, M.D.(3) |
|
|
|
|
|
|
535,000 |
|
|
|
535,000 |
|
|
|
* |
% |
All current executive officers and directors as a group
(6 persons)(4) |
|
|
5,640 |
|
|
|
1,722,120 |
|
|
|
1,727,760 |
|
|
|
2.6 |
% |
|
|
|
* |
|
Less than one percent. |
|
(1) |
|
Current director as of March 5, 2010. |
|
(2) |
|
Current executive officer as of March 5, 2010. |
|
(3) |
|
Former executive officer terminated April 20, 2009. |
|
(4) |
|
The six current executive officers and directors are comprised of
Dr. Smith, Dr. Fildes, Mr. Martin, Dr. Young, Dr. Gillespie and
Ms. Sloan (each of whom is included within the table above). |
|
|
|
Item 14. |
|
Principal Accountant Fees and Services. |
The following table presents the aggregate fees agreed to by the Company for the annual and
statutory audits for fiscal years ended December 31, 2008 and 2009, and all other fees paid by us
during 2008 and 2009 to Ernst & Young LLP:
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
2009 |
|
Audit Fees |
|
$ |
298,861 |
|
|
$ |
141,210 |
|
Audit Related Fees |
|
|
|
|
|
|
|
|
Tax Fees |
|
|
87,000 |
|
|
|
17,000 |
|
All Other Fees |
|
|
45,000 |
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
430,861 |
|
|
$ |
158,210 |
|
|
|
|
|
|
|
|
25
Audit Fees. The fees identified under this caption were for professional services rendered by
Ernst & Young LLP for the audit of our annual financial statements and internal control over
financial reporting and for the review of the financial statements included in our quarterly
reports on Form 10-Q. The amounts also include fees for services that are normally provided by the
auditor in connection with regulatory filings and engagements for the years identified. Audit fees
in 2008 include an aggregate of $65,025 in fees paid in connection with our filing of registration
statements on Form S-8 and Form S-3. Audit fees in 2009 include an aggregate of $26,210 in fees
paid in connection with our filing of registration statements on Form S-3 and S-4.
Tax Fees. Tax fees consist principally of assistance related to tax compliance and reporting.
All Other Fees. These fees consist primarily of accounting consultation fees related to
potential collaborative agreements.
Pre-approval Policy. Our audit committee approves in advance all services provided by our
independent registered public accounting firm. All engagements of our independent registered public
accounting firm in 2008 and 2009 were pre-approved by the audit committee.
26
PART IV
Item 15. Exhibits, Financial Statement Schedules.
(a) Documents filed as part of this report.
1. |
|
The following consolidated financial statements of La Jolla Pharmaceutical Company are filed
as part of this report under Item 8 Financial Statements and Supplementary Data: |
2. Financial Statement Schedules.
These schedules are omitted because they are not required, or are not applicable, or the
required information is shown in the consolidated financial statements or notes thereto.
3. Exhibits.
The exhibit index attached to this report is incorporated by reference herein.
27
SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934,
the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized.
|
|
|
|
|
|
LA JOLLA PHARMACEUTICAL COMPANY
|
|
|
By: |
/s/ Deirdre Y. Gillespie
|
|
April 15, 2010 |
|
Deirdre Y. Gillespie, M.D. |
|
|
|
President, Chief Executive Officer and
Assistant Secretary |
|
|
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been
signed below by the following persons on behalf of the registrant and in the capacities and on the
dates indicated.
|
|
|
|
|
Signature |
|
Title |
|
Date |
|
|
|
|
|
/s/ Deirdre Y. Gillespie
Deirdre Y. Gillespie, M.D
|
|
President, Chief Executive Officer and Assistant Secretary
(Principal Executive Officer)
|
|
April 15, 2010 |
|
|
|
|
|
/s/ Gail A. Sloan
Gail A. Sloan
|
|
Vice President of Finance and Secretary (Principal Financial
and Accounting Officer)
|
|
April 15, 2010 |
|
|
|
|
|
/s/ Robert A. Fildes
Robert A. Fildes, Ph.D.
|
|
Director
|
|
April 15, 2010 |
|
|
|
|
|
/s/ Stephen M. Martin
Stephen M. Martin
|
|
Director
|
|
April 15, 2010 |
|
|
|
|
|
/s/ Craig R. Smith
Craig R. Smith, M.D.
|
|
Director
|
|
April 15, 2010 |
|
|
|
|
|
/s/ Frank E. Young
Frank E. Young, M.D., Ph.D.
|
|
Director
|
|
April 15, 2010 |
28
Report of Independent Registered Public Accounting Firm
The Board of Directors and Stockholders of La Jolla Pharmaceutical Company
We have audited the accompanying consolidated balance sheets of La Jolla Pharmaceutical Company as
of December 31, 2009 and 2008, and the related consolidated statements of operations, stockholders
equity, and cash flows for each of the two years in the period ended December 31, 2009. These
financial statements are the responsibility of the Companys management. Our responsibility is to
express an opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight
Board (United States). Those standards require that we plan and perform the audit to obtain
reasonable assurance about whether the financial statements are free of material misstatement. We
were not engaged to perform an audit of the Companys internal control over financial reporting.
Our audits included consideration of internal control over financial reporting as a basis for
designing audit procedures that are appropriate in the circumstances, but not for the purpose of
expressing an opinion on the effectiveness of the Companys internal control over financial
reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test
basis, evidence supporting the amounts and disclosures in the financial statements, assessing the
accounting principles used and significant estimates made by management, and evaluating the overall
financial statement presentation. We believe that our audits provide a reasonable basis for our
opinion.
In our opinion, the financial statements referred to above present fairly, in all material
respects, the consolidated financial position of La Jolla Pharmaceutical Company at December 31,
2009 and 2008, and the consolidated results of its operations and its cash flows for each of the
two years in the period ended December 31, 2009, in conformity with U.S. generally accepted
accounting principles.
The accompanying financial statements have been prepared assuming that La Jolla Pharmaceutical
Company will continue as a going concern. As more fully described in Note 1, La Jolla
Pharmaceutical Company has incurred recurring operating losses, an accumulated deficit of $424.3
million as of December 31, 2009 and has no current source of revenues or financing. These
conditions, among others, as discussed in Note 1 to the consolidated financial statements, raise
substantial doubt about La Jolla Pharmaceutical Companys ability to continue as a going concern.
Managements plans in regard to these matters also are described in Note 1. The 2009 consolidated
financial statements do not include any adjustments to reflect the possible future effects on the
recoverability and classification of assets or the amounts and classifications of liabilities that
may result from the outcome of this uncertainty.
/s/ Ernst & Young LLP
San Diego, California
April 15, 2010
F-1
La Jolla Pharmaceutical Company
Consolidated Balance Sheets
(In thousands, except share and par value amounts)
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
4,254 |
|
|
$ |
9,447 |
|
Short-term investments, available-for-sale |
|
|
|
|
|
|
10,000 |
|
Prepaids and other current assets |
|
|
586 |
|
|
|
785 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
4,840 |
|
|
|
20,232 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
|
|
|
|
357 |
|
Patent costs and other assets, net |
|
|
|
|
|
|
250 |
|
|
|
|
|
|
|
|
|
|
$ |
4,840 |
|
|
$ |
20,839 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
125 |
|
|
$ |
4,626 |
|
Accrued clinical/regulatory expenses |
|
|
|
|
|
|
3,957 |
|
Accrued expenses |
|
|
323 |
|
|
|
1,008 |
|
Accrued payroll and related expenses |
|
|
173 |
|
|
|
1,549 |
|
Credit facility |
|
|
|
|
|
|
5,933 |
|
Current portion of obligations under notes payable |
|
|
|
|
|
|
152 |
|
Current portion of obligations under capital leases |
|
|
|
|
|
|
11 |
|
|
|
|
|
|
|
|
Total current liabilities |
|
|
621 |
|
|
|
17,236 |
|
|
|
|
|
|
|
|
|
|
Non-current portion of obligations under notes payable |
|
|
|
|
|
|
179 |
|
Non-current portion of obligations under capital leases |
|
|
|
|
|
|
34 |
|
|
|
|
|
|
|
|
|
|
Commitments |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders equity: |
|
|
|
|
|
|
|
|
Preferred stock, $0.01 par value; 8,000,000 shares
authorized, no shares issued or outstanding |
|
|
|
|
|
|
|
|
Common stock, $0.01 par value; 225,000,000 shares
authorized, 65,722,648 and 55,549,528 shares issued
and outstanding at December 31, 2009 and 2008,
respectively |
|
|
657 |
|
|
|
555 |
|
Additional paid-in capital |
|
|
427,883 |
|
|
|
418,522 |
|
Accumulated deficit |
|
|
(424,321 |
) |
|
|
(415,687 |
) |
|
|
|
|
|
|
|
Total stockholders equity |
|
|
4,219 |
|
|
|
3,390 |
|
|
|
|
|
|
|
|
|
|
$ |
4,840 |
|
|
$ |
20,839 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-2
La Jolla Pharmaceutical Company
Consolidated Statements of Operations
(In thousands, except per share amounts)
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
Revenue from collaboration agreement |
|
$ |
8,125 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
9,576 |
|
|
|
51,025 |
|
General and administrative |
|
|
7,193 |
|
|
|
9,702 |
|
Asset impairments |
|
|
|
|
|
|
2,810 |
|
|
|
|
|
|
|
|
Total expenses |
|
|
16,769 |
|
|
|
63,537 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(8,644 |
) |
|
|
(63,537 |
) |
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
(13 |
) |
|
|
(96 |
) |
Interest and other income |
|
|
23 |
|
|
|
779 |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,634 |
) |
|
$ |
(62,854 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.14 |
) |
|
$ |
(1.26 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share |
|
|
63,326 |
|
|
|
49,689 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-3
La Jolla Pharmaceutical Company
Consolidated Statements of Stockholders Equity
For the Years Ended December 31, 2008 and 2009
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
Other |
|
|
|
|
|
Total |
|
|
|
Preferred stock |
|
|
Common stock |
|
|
paid-in |
|
|
comprehensive |
|
|
Accumulated |
|
|
stockholders |
|
|
|
Shares |
|
|
Amount |
|
|
Shares |
|
|
Amount |
|
|
capital |
|
|
income (loss) |
|
|
deficit |
|
|
equity |
|
Balance at December 31, 2007 |
|
|
|
|
|
$ |
|
|
|
|
39,630 |
|
|
$ |
396 |
|
|
$ |
385,944 |
|
|
$ |
14 |
|
|
$ |
(352,833 |
) |
|
$ |
33,521 |
|
Issuance of common stock,
net |
|
|
|
|
|
|
|
|
|
|
15,615 |
|
|
|
156 |
|
|
|
27,877 |
|
|
|
|
|
|
|
|
|
|
|
28,033 |
|
Issuance of common stock
under Employee Stock
Purchase Plan |
|
|
|
|
|
|
|
|
|
|
304 |
|
|
|
3 |
|
|
|
287 |
|
|
|
|
|
|
|
|
|
|
|
290 |
|
Exercise of stock options |
|
|
|
|
|
|
|
|
|
|
1 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
3 |
|
Share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,411 |
|
|
|
|
|
|
|
|
|
|
|
4,411 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,854 |
) |
|
|
(62,854 |
) |
Net unrealized losses on
available-for-sale
securities |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(14 |
) |
|
|
|
|
|
|
(14 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Comprehensive loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(62,868 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
55,550 |
|
|
|
555 |
|
|
|
418,522 |
|
|
|
|
|
|
|
(415,687 |
) |
|
|
3,390 |
|
Issuance of preferred stock |
|
|
339 |
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
6,807 |
|
|
|
|
|
|
|
|
|
|
|
6,810 |
|
Conversion of preferred
stock, net |
|
|
(339 |
) |
|
|
(3 |
) |
|
|
10,173 |
|
|
|
102 |
|
|
|
(99 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,653 |
|
|
|
|
|
|
|
|
|
|
|
2,653 |
|
Net loss |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(8,634 |
) |
|
|
(8,634 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
|
|
|
$ |
|
|
|
|
65,723 |
|
|
$ |
657 |
|
|
$ |
427,883 |
|
|
$ |
|
|
|
$ |
(424,321 |
) |
|
$ |
4,219 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes.
F-4
La Jolla Pharmaceutical Company
Consolidated Statements of Cash Flows
(In thousands)
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
Operating activities |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(8,634 |
) |
|
$ |
(62,854 |
) |
Adjustments to reconcile net loss to net cash used for operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
117 |
|
|
|
990 |
|
(Gain) loss on write-off/disposal of patents, property and equipment |
|
|
(347 |
) |
|
|
199 |
|
Loss on impairment of patents, property and equipment and licenses |
|
|
|
|
|
|
2,810 |
|
Share-based compensation expense |
|
|
2,653 |
|
|
|
4,411 |
|
Expense reduction from settlement of vendor obligations |
|
|
(2,743 |
) |
|
|
|
|
Amortization of investment premium/discount |
|
|
|
|
|
|
240 |
|
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Prepaids and other current assets |
|
|
199 |
|
|
|
233 |
|
Accounts payable and accrued liabilities |
|
|
(6,400 |
) |
|
|
442 |
|
Accrued payroll and related expenses |
|
|
(1,376 |
) |
|
|
350 |
|
|
|
|
|
|
|
|
Net cash used for operating activities |
|
|
(16,531 |
) |
|
|
(53,179 |
) |
|
|
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
|
|
Sales of short-term investments |
|
|
10,000 |
|
|
|
24,665 |
|
Net proceeds from sale of patents and property and equipment |
|
|
861 |
|
|
|
44 |
|
Additions to property and equipment |
|
|
(18 |
) |
|
|
(506 |
) |
Increase in patent costs and other assets |
|
|
(6 |
) |
|
|
(116 |
) |
|
|
|
|
|
|
|
Net cash provided by investing activities |
|
|
10,837 |
|
|
|
24,087 |
|
|
|
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
|
|
Net proceeds from issuance of common stock |
|
|
|
|
|
|
28,326 |
|
Net proceeds from issuance of preferred stock |
|
|
6,810 |
|
|
|
|
|
Proceeds from credit facility |
|
|
|
|
|
|
6,000 |
|
Payments on credit facility |
|
|
(5,933 |
) |
|
|
|
|
Payments on obligations under notes payable |
|
|
(331 |
) |
|
|
(151 |
) |
Payments on obligations under capital leases |
|
|
(45 |
) |
|
|
(9 |
) |
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
501 |
|
|
|
34,166 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(Decrease) increase in cash and cash equivalents |
|
|
(5,193 |
) |
|
|
5,074 |
|
Cash and cash equivalents at beginning of period |
|
|
9,447 |
|
|
|
4,373 |
|
|
|
|
|
|
|
|
Cash and cash equivalents at end of period |
|
$ |
4,254 |
|
|
$ |
9,447 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
13 |
|
|
$ |
96 |
|
|
|
|
|
|
|
|
See accompanying notes.
F-5
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
1. Organization and Summary of Significant Accounting Policies
Organization and Business Activity
La Jolla Pharmaceutical Company (the Company) is a biopharmaceutical company formed to improve
and preserve human life by developing innovative pharmaceutical products.
Basis of Presentation
The accompanying consolidated financial statements have been prepared assuming that the
Company will continue as a going concern. This basis of accounting contemplates the recovery of the
Companys assets and the satisfaction of liabilities in the normal course of business and does
not include any adjustments to reflect the possible future effects on the recoverability and
classification of assets or the amounts and classification of liabilities that might be necessary
should the Company be unable to continue as a going concern. While the basis of presentation
remains that of a going concern, the Company has a history of
recurring losses from operations, had an accumulated deficit
of $424,321,000 as of December 31, 2009, and currently has
no source of revenues or financing. The Company is currently evaluating strategic alternatives
which may include mergers, license agreements, third party collaborations to develop new products
or a wind down of the Company. The Companys current inability
to generate future cash flows and recent inability to consummate a
strategic transaction raise substantial doubt about the Companys ability to continue
as a going concern.
On January 4, 2009, the Company entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF, a wholly-owned subsidiary of BioMarin Pharmaceutical
Inc. (BioMarin Pharma), granting BioMarin CF co-exclusive rights to develop and commercialize
Riquent (and certain potential follow-on products) (collectively, Riquent) in the Territory,
and the non-exclusive right to manufacture Riquent anywhere in the world. The Territory includes
all countries of the world except the Asia-Pacific Territory (i.e., all countries of East Asia,
Southeast Asia, South Asia, Australia, New Zealand, and other countries of Oceania). Under the
terms of the Development Agreement, BioMarin CF paid the Company a non-refundable commencement
payment of $7,500,000 and through BioMarin Pharma, paid $7,500,000 for a newly designated series of
preferred stock (the Series B-1 Preferred Stock), pursuant to a related securities purchase
agreement described more fully at Note 4, below.
In February 2009, the Company announced that an Independent Monitoring Board for the Riquent® Phase
3 ASPEN study had completed its review of the first interim efficacy analysis and determined that
continuing the study was futile. Based on these results, the Company immediately discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. The Company had previously devoted
substantially all of its research, development and clinical efforts and financial resources toward
the development of Riquent. In connection with the termination of the clinical trials for Riquent,
the Company significantly reduced its operating costs, ceased all Riquent manufacturing and
regulatory activities and effected a reduction in force in April 2009 (see Note 6).
Following the futile results of the first interim efficacy analysis of Riquent received in February
2009, BioMarin CF elected not to exercise its full license rights to the Riquent program under the
Development Agreement. Thus, the Development Agreement between the parties terminated on March 27,
2009 in accordance with its terms. Pursuant to the Securities
Purchase Agreement between the Company and
BioMarin Pharma, all of the Companys preferred shares purchased by BioMarin Pharma were converted
into common shares. All rights to Riquent were returned to the Company.
In July 2009, the Company announced that, in light of the alternatives available to the Company at
the time, a wind down of the Companys business would be in the best interests of the Company and
its stockholders. Although the Board of Directors (the Board) approved a Plan of Complete
Liquidation and Dissolution (the Plan of Dissolution) in September 2009, it was subject to
approval by holders of at least a majority in voting power of the Companys outstanding shares. The
Company called a special meeting of stockholders to vote on the Plan of Dissolution, but the
majority of the Companys stockholders failed to return their proxy cards or otherwise indicate
their votes with respect to this proposal. As a result, the Company was not able to obtain the
requisite quorum to conduct business at the special meeting and the special meeting was therefore
cancelled.
F-6
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
On December 4, 2009, the Company entered into an Agreement and Plan of Reorganization (the Merger
Agreement) by and among the Company, Jewel Merger Sub, Inc. (Merger Sub) and Adamis
Pharmaceuticals Corporation (Adamis). The transaction contemplated by the Merger Agreement was
structured as a reverse triangular merger, in which Merger Sub, a wholly-owned subsidiary of the
Company, would merge with and into Adamis, with Adamis surviving (the Merger). On March 3, 2010,
the Company and Adamis agreed to terminate the Merger Agreement as a result of the failure of the
Companys stockholders to vote in sufficient quantities for there to be a quorum to hold the
stockholders meeting to approve the proposals related to the Merger. The solicitation of further
votes was cancelled due to the delisting of the Companys common stock from Nasdaq.
Effective at the open of business on March 4, 2010, the Companys common stock was suspended and
delisted from The NASDAQ Stock Market (Nasdaq) and began trading on The Pink OTC Markets, Inc.
The delisting was the result of Nasdaqs determination that the Company had nominal assets, other
than cash, and had nominal operations.
Principles of Consolidation
The accompanying consolidated financial statements include the accounts of La Jolla
Pharmaceutical Company and its wholly-owned subsidiaries, La Jolla Limited, which was incorporated
in England in October 2004, and Jewel Merger Sub, Inc., which was incorporated in Delaware in
December 2009. There have been no significant transactions related to either subsidiary since their
inception. La Jolla Limited was formally dissolved during October 2009 with no resulting accounting
consequences.
Use of Estimates
The preparation of consolidated financial statements in conformity with United States generally
accepted accounting principles (GAAP) requires management to make estimates and
assumptions that affect the amounts reported in the consolidated financial statements and
disclosures made in the accompanying notes to the consolidated financial statements. Actual results
could differ materially from those estimates.
Cash, Cash Equivalents and
Short-Term Investments
The Company considers all highly liquid
investments with a maturity of three months or less when purchased to be cash
equivalents. Short-term investments are classified as available-for-sale in
accordance with The ASC Topic of Investments. Available-for-sale
securities are carried at fair value, with the unrealized gains and losses
reported in other comprehensive income (loss). The amortized cost of debt
securities in this category is adjusted for amortization of premiums and
accretion of discounts to maturity. Such amortization is included in interest
income. Realized gains and losses and declines in value judged to be
other-than-temporary, if any, on available-for-sale securities are included in
interest income. The cost of securities sold is based on the specific
identification method. Interest and dividends on securities classified as
available-for-sale are included in interest income.
Revenue Recognition
The Company applies the revenue recognition criteria outlined in the ASC Topic of Revenue Recognition. Upfront product
and technology license fees under multiple-element arrangements are deferred and recognized over the period of such
services or performance if such arrangements require on-going services or performance. Non-refundable amounts received
for substantive milestones are recognized upon achievement of the milestone. Any amounts received prior to satisfying
the Companys revenue recognition criteria are recorded as deferred revenue in the accompanying consolidated balance
sheets.
The Companys sole
source of revenue in the consolidated financial statements related to a January 4, 2009 Development Agreement with BioMarin CF which
contained multiple potential revenue elements, including non-refundable upfront fees. The Development Agreement was
terminated on March 27, 2009 following the failure of the Phase 3 ASPEN trial at which time the Company had no
remaining on-going services or performance. The Company recognized $8,125,000 as collaboration revenue upon termination
of the Development Agreement.
Impairment of Long-Lived Assets
If indicators of impairment exist, the Company assesses the recoverability of the affected
long-lived assets by determining whether the carrying value of such assets can be recovered through
the undiscounted future operating cash flows.
F-7
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
As a result of the futility determination in the Phase 3 ASPEN trial, the Company discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. Based on these events, the future cash
flows from the Companys
Riquent-related patents were no longer expected to exceed their carrying values and the assets
became impaired as of December 31, 2008. Accordingly, the Company recorded a non-cash charge for
the impairment of long-lived assets of $2,810,000 for the year ended December 31, 2008 to write
down the value of the Companys long-lived assets to their estimated fair values. Impairment
charges included $2,061,000 for patents, $724,000 for property and equipment, and $25,000 for
licenses. Although no impairment charges were recorded during 2009, the Company sold, disposed of,
or wrote off all of its remaining long-lived assets during the year ended December 31, 2009 for a
gain of $347,000.
Property and Equipment
Property and equipment is stated at cost and has been depreciated using the straight-line method
over the estimated useful lives of the assets (primarily five years). Leasehold improvements and
equipment under capital leases are stated at cost and have been depreciated on a straight-line
basis over the shorter of the estimated useful life or the lease term.
Property and equipment is comprised of the following (in thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Laboratory equipment |
|
$ |
|
|
|
$ |
6,171 |
|
Computer equipment and software |
|
|
2,186 |
|
|
|
4,654 |
|
Furniture and fixtures |
|
|
|
|
|
|
477 |
|
Leasehold improvements |
|
|
|
|
|
|
3,275 |
|
|
|
|
|
|
|
|
|
|
|
2,186 |
|
|
|
14,577 |
|
Less: Accumulated depreciation |
|
|
(2,186 |
) |
|
|
(14,220 |
) |
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
357 |
|
|
|
|
|
|
|
|
Depreciation expense for the years ended December 31, 2009 and 2008 was $115,000 and $737,000,
respectively. Impairment charges of $724,000 during 2008 were reflected as a reduction to the
above noted 2008 costs.
Patents
During 2009, all remaining patents were sold, disposed of, or written off.
Prior to 2009, the Company had filed numerous patent applications with the United States Patent and
Trademark Office and in foreign countries. Legal costs and expenses incurred in connection with
pending patent applications were capitalized. Costs related to issued patents were amortized using
the straight-line method over the lesser of the remaining useful life of the related technology or
the remaining patent life, commencing on the date the patent was issued.
As a result of the sale, disposal, or write-off of all remaining patents as of December 31, 2009,
total issued and pending patent application costs and accumulated amortization were $0 as of
December 31, 2009. As of December 31, 2008, total issued patent application costs (net of 2008
impairment charges) and accumulated amortization were $1,159,000 and $1,116,000, respectively.
Total pending patent application costs (less 2008 impairment charges) were $207,000 at December 31,
2008. Capitalized costs related to patent applications were charged to operations at the time a
determination is made not to pursue such applications or they become impaired. Amortization expense
for the years ended December 31, 2009 and 2008 was $2,000 and $245,000, respectively.
Accrued Clinical/Regulatory Expenses
As a result of the Company discontinuing the Riquent Phase 3 ASPEN study and the development of
Riquent, all clinical and regulatory activities were ceased and no related accruals were required
as of December 31, 2009.
F-8
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
The Company reviewed and accrued clinical trial and regulatory-related expenses based on work
performed, which relied on estimates of total costs incurred based on patient enrollment,
completion of studies and other events. The Company followed this method since reasonably
dependable estimates of the costs applicable to various stages of a clinical trial could be made.
Share-Based Compensation
Share-based compensation expense for the years ended December 31, 2009 and 2008 was approximately
$2,653,000 and $4,422,000, respectively. As of December 31, 2009, there was approximately $976,000
of total unrecognized compensation cost related to non-vested share-based payment awards granted
under all equity compensation plans. As share-based compensation expense recognized for fiscal
years 2009 and 2008 is based on awards ultimately expected to vest, share-based compensation
expense has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant
and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates.
Total unrecognized compensation cost will be adjusted for future changes in estimated forfeitures.
The Company expects to recognize that cost over a weighted-average period of 0.8 years.
Deferred charges for options granted to non-employees, other than non-employee directors, are
periodically remeasured as the options vest. In December 2008, the Company granted non-qualified
stock options to purchase a total of 15,000 shares of common stock to a consultant at an exercise
price equal to the fair market value of the stock at the date of the grant. The Company recognized
compensation expense for these stock option grants of approximately ($1,000) and $1,000 for the
years ended December 31, 2009 and 2008, respectively. In September and October 2007, the Company
granted non-qualified stock options to purchase a total of 12,000 shares of common stock to
consultants at an exercise price equal to the fair market value of the stock at the date of each
grant. For the year ended December 31, 2008, the Company recognized compensation (credit) expense
for these stock option grants of approximately ($11,000). No compensation for these stock option
grants was recognized during the year ended December 31, 2009.
The Company utilizes the Black-Scholes option-pricing model as its method of valuation for stock
options and purchases under the ESPP. The Companys determination of the fair value of share-based
payment awards on the date of grant using an option-pricing model is affected by the Companys
stock price as well as assumptions regarding a number of highly complex and subjective variables.
These variables include, but are not limited to, the Companys expected stock price volatility over
the term of the awards and actual and projected employee stock option exercise behaviors.
Share-Based Award Valuation and Expense Information
The following table summarizes share-based compensation expense (in thousands) related to employee
and director stock options and restricted stock for the years ended December 31, 2009 and 2008, as
well as share-based compensation expense related to ESPP purchases for the year ended December 31,
2008:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Research and development |
|
$ |
632 |
|
|
$ |
1,961 |
|
General and administrative |
|
|
2,021 |
|
|
|
2,461 |
|
|
|
|
|
|
|
|
Share-based compensation expense included in operating expenses |
|
$ |
2,653 |
|
|
$ |
4,422 |
|
|
|
|
|
|
|
|
For the years ended December 31, 2009 and 2008, the Company estimated the fair value of each option
grant on the date of grant using the Black-Scholes option-pricing model with the following
weighted-average assumptions:
F-9
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
Options:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Risk-free interest rate |
|
|
0.6 |
% |
|
|
3.2 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
295.0 |
% |
|
|
115.1 |
% |
Expected life (years) |
|
|
5.6 |
|
|
|
5.6 |
|
For the year ended December 31, 2008, the Company estimated the fair value of ESPP purchase rights
on the date of grant using the Black-Scholes option-pricing model with the following
weighted-average assumptions:
ESPP:
|
|
|
|
|
|
|
December 31, |
|
|
|
2008 |
|
Risk-free interest rate |
|
|
1.1 |
% |
Dividend yield |
|
|
0.0 |
% |
Volatility |
|
|
99.6 |
% |
Expected life |
|
3 months |
|
The weighted-average fair values of options granted were $1.72 and $1.70 for the years ended
December 31, 2009 and 2008, respectively. The weighted-average purchase price of shares purchased
through the ESPP was $0.95 for the year ended December 31, 2008. No ESPP purchases were made during
2009.
The risk-free interest rate assumption is based on observed interest rates appropriate for the term
of the Companys employee and director stock options and ESPP purchases. The dividend yield
assumption is based on the Companys history and expectation of dividend payouts. The Company has
never paid dividends on its common stock and the Company does not anticipate paying dividends in
the foreseeable future.
The Company used historical stock price volatility as the expected volatility assumption required
in the Black-Scholes option-pricing model. The selection of the historical volatility approach was
based on the availability of historical stock prices for the duration of the awards expected term
and the Companys assessment that historical volatility is more representative of future stock
price trends than other available methods.
The expected life of employee and director stock options represents the weighted-average period the
stock options are expected to remain outstanding. Using historical option
exercise data, the expected life for option grants made during the
years ended December 31, 2009 and 2008 was
5.6 years for the new and existing employee grants and the director grants. The expected life for ESPP purchase rights
represents the length of each purchase period. Because employees purchase stock quarterly, the
expected term for ESPP purchase rights is three months for shares purchased during the year ended
December 31, 2008. No ESPP purchases were made during 2009.
Because share-based compensation expense recognized in the Consolidated Statement of Operations for
fiscal years 2009 and 2008 is based on awards ultimately expected to vest, it has been reduced for
estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in
subsequent periods if actual forfeitures differ from those estimates. Forfeitures were estimated
based on historical experience for compensation expense recognized for fiscal year 2008. During
2009, forfeitures were estimated based on actual events; primarily the reduction in force that
occurred during April 2009 (see Note 6).
Restricted Stock
There was no restricted stock issued during the years ended December 31, 2009 and 2008. In
addition, no compensation expense related to restricted stock was recognized during the years ended
December 31, 2009 and 2008.
F-10
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
Restricted Stock Units
On December 31, 2009, the Company granted 2,021,024 restricted stock units (RSUs) to the
Companys three remaining employees where each RSU represented a contingent right to receive one
share of the Companys common stock. The RSUs were to vest upon the closing of the Merger, subject to the
continued employment of the recipient through the closing date of the Merger. The RSUs were valued
at the fair market value of the Companys common stock on the grant date. The value of the RSUs on
December 31, 2009 was $344,000 and no compensation expense for these RSUs was recognized during
2009. As a result of the termination of the Merger in March 2010, the RSUs were cancelled.
Net Loss Per Share
Basic and diluted net loss per share is computed using the weighted-average number of common shares
outstanding during the periods. Earnings per share (EPS) is calculated by dividing the
net income or loss by the weighted-average number of common shares outstanding for the period,
without consideration for common share equivalents. Diluted EPS is computed by dividing the net
income or loss by the weighted-average number of common share equivalents outstanding for the
period determined using the treasury-stock method. For purposes of this calculation, stock options
and warrants are considered to be common stock equivalents and are only included in the calculation
of diluted earnings per share when their effect is dilutive.
Because
the Company has incurred a net loss for both of the two years presented in the Consolidated
Statements of Operations, stock options and warrants are not included in the computation of net
loss per share because their effect is anti-dilutive. The shares used to compute basic and diluted
net loss per share represent the weighted-average common shares outstanding.
Comprehensive Loss
Unrealized gains and losses on available-for-sale securities are included in other comprehensive
income (loss).
Recently Issued Accounting Standards
In June 2009, the Financial Accounting Standards Board (FASB) approved the FASB Accounting
Standards Codification (the Codification) when it issued Statement of Financial Accounting
Standards No. 168, The FASB Accounting Standards Codification and the Hierarchy of Generally
Accepted Accounting Principles, which is included in The Accounting Standards Codification (ASC)
Topic of Generally Accepted Accounting Principles (the Topic). All existing accounting standard
documents, such as FASB, American Institute of Certified Public Accountants, Emerging Issues Task
Force and other related literature, excluding guidance from the Securities and Exchange Commission
(SEC), have been superseded by the Codification. All other non-grandfathered, non-SEC accounting
literature not included in the Codification has become non-authoritative. The Codification did not
change GAAP, but instead introduced a new structure that combines all authoritative standards into
a comprehensive, topically-organized online database. The Topic is effective for financial
statements issued for interim and annual periods ending after September 15, 2009. The Topic impacts
the Companys financial statement disclosures as all future references to authoritative accounting
literature will be referenced in accordance with the Codification. As a result of the
implementation of the Codification during the quarter ended September 30, 2009, previous references
to accounting standards and literature are no longer applicable.
F-11
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
2. Cash Equivalents and Short-term Investments
As of December 31, 2009, the Company held cash of $4,254,000 and held no available-for-sale
securities or short-term investments.
The following is a summary of the Companys available-for-sale securities as of December 31, 2008
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross |
|
|
Gross |
|
|
|
|
|
|
|
|
|
|
|
|
Amortized |
|
|
Unrealized |
|
|
Unrealized |
|
|
Realized |
|
|
Realized |
|
|
Estimated Fair |
|
|
|
Cost |
|
|
Gains |
|
|
Losses |
|
|
Gains |
|
|
Losses |
|
|
Value |
|
December 31, 2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Money market accounts |
|
$ |
2,686 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,686 |
|
Asset-backed auction rate securities |
|
|
10,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(2,270 |
) |
|
|
7,730 |
|
Auction rate security rights |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,270 |
|
|
|
|
|
|
|
2,270 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
12,686 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,270 |
|
|
$ |
(2,270 |
) |
|
$ |
12,686 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The amortized cost of debt securities held as of December 31, 2008 was adjusted for amortization of
premiums and accretion of discounts to maturity. Included in cash and cash equivalents at December
31, 2008 were $2,686,000 of securities classified as available-for-sale which were sold during 2009
to support current operations. As of December 31, 2008, available-for-sale securities and cash
equivalents of $2,686,000 had a maturity date of one year or less and $10,000,000 were due after
one year.
As of December 31, 2008, the Companys investment securities consisted of money market funds
invested in U.S. Treasury bills and student loan auction rate securities. During 2008, there was
insufficient demand at auction for all four of the Companys auction rate securities. As a result,
these securities were not liquid. The Company recorded a realized impairment loss on
these securities of $2,270,000 in 2008. The Companys auction rate securities were classified as
short-term investments, and the realized impairment loss was included in the Companys statement of
operations for the year ended December 31, 2008.
During the fourth quarter of 2008, the Companys broker-dealer, UBS, extended an offer of Auction
Rate Securities Rights (ARS Rights) to holders of illiquid auction rate securities that
were maintained by UBS as of February 13, 2008. The ARS Rights provided the holder with the ability
to sell the auction rate securities, along with the ARS Rights, to UBS at the par value of the
auction rate securities, during an applicable exercise period. The ARS Rights were not
transferable, not tradeable, and were not quoted or listed on any securities exchange or other
trading network.
During November 2008, the Company executed a written agreement with UBS to participate in the ARS
Rights program for all $10,000,000 of its outstanding auction rate securities, all of which were
maintained by UBS. ARS Rights represent an asset akin to a put option, whereby the Company has the
right to put the auction rate securities back to the broker-dealer during the exercise period for
a payment equal to the par value of the auction rate securities. As of December 31, 2008, the fair
value of the ARS Rights were recorded as a realized gain of $2,270,000 and a corresponding
short-term investment. The realized gain from recording the ARS Rights fully offset the realized
impairment loss on auction rate securities that was recorded during 2008. During January 2009, all
of the Companys auction rate securities were sold to UBS at par value of $10,000,000 pursuant to
the ARS Rights agreement.
F-12
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
3. Fair Value of Financial Instruments
Fair value is defined under The ASC Topic of Fair Value Measurements and Disclosures as the
exchange price that would be received for an asset or paid to transfer a liability (an exit price)
in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair
value under The ASC Topic of Fair Value Measurements and Disclosures must maximize the use of
observable inputs and minimize the use of unobservable inputs. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the
last unobservable, that may be used to measure fair value which are the following:
|
|
|
Level 1 Quoted prices in active markets for identical assets or liabilities. |
|
|
|
|
Level 2 Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable or
can be corroborated by observable market data for substantially the full term
of the assets or liabilities. |
|
|
|
|
Level 3 Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets or
liabilities. |
As of December 31, 2009, cash and cash equivalents were comprised of cash in checking accounts. The
Company held no investments as of December 31, 2009.
As of December 31, 2008, cash and cash equivalents were comprised of short-term, highly liquid
investments with maturities of 90 days or less from the date of purchase. Investments were
comprised of available-for-sale securities recorded at estimated fair value determined using level
3 inputs. Unrealized gains and losses associated with the Companys investments, if any, were
reported in stockholders equity.
At December 31, 2008, short-term investments were comprised of $10,000,000 invested in auction rate
securities, which were sold to UBS at par value in January 2009 pursuant to an Auction Rate
Securities Agreement executed in November 2008.
4. Development and Stock Purchase Agreements
On January 4, 2009, the Company entered into the Development Agreement with BioMarin CF, a
wholly-owned subsidiary of BioMarin Pharma, granting BioMarin CF co-exclusive rights to develop and
commercialize Riquent (and certain potential follow-on products) (collectively, Riquent) in the
Territory, and the non-exclusive right to manufacture Riquent anywhere in the world. The
Territory includes all countries of the world except the Asia-Pacific Territory (i.e., all
countries of East Asia, Southeast Asia, South Asia, Australia, New Zealand, and other countries of
Oceania).
Under the terms of the Development Agreement, BioMarin CF paid the Company a non-refundable
commencement payment of $7,500,000 and, through BioMarin Pharma, paid $7,500,000 for a newly
designated series of preferred stock (the Series B-1 Preferred Stock), pursuant to a related
securities purchase agreement described more fully below. The stated amount paid for the preferred
stock was $625,000 in excess of its fair value, such amount was accounted for as additional
consideration paid for the development arrangement.
Following the futile results of the first interim efficacy analysis of Riquent received in February
2009, BioMarin CF elected not to exercise its full license rights to the Riquent program under the
Development Agreement. Thus, the Development Agreement between the parties terminated on March 27,
2009 in accordance with its terms. All rights to Riquent were returned to the Company. Accordingly,
the $8,125,000 related to the Development Agreement was recorded as revenue in the quarter ended
March 2009.
F-13
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
In connection with the Development Agreement, the Company also entered into a securities purchase
agreement, dated as of January 4, 2009 with BioMarin Pharma. In accordance with the terms of the
agreement, on January 20, 2009, the Company sold 339,104 shares of Series B-1 Preferred Stock at a
price per share of $22.1171 and received
$7,500,000 which was in excess of the fair value of the preferred stock. On March 27, 2009, in
connection with the termination of the Development Agreement, the Series B-1 Preferred Stock
converted into 10,173,120 shares of Common Stock pursuant to the terms of the securities purchase
agreement. The premium over the fair value of the stock issued of $625,000 was added to the value
of the Development Agreement.
5. Commitments
The Company leased two adjacent buildings in San Diego, California covering a total of
approximately 54,000 square feet. Both building leases expired in July 2009. Pursuant to one of the
leases, the Company was responsible for completing modifications to the leased building prior to
lease expiration. In July 2009, approximately $315,000 was paid in accordance with the lease
provisions upon lease expiration and exit of the buildings.
In addition, the Company early terminated its operating leases during the quarter ended June 30,
2009, and as a result paid a termination fee of $100,000 in
September 2009. There were no material operating
leases remaining as of December 31, 2009.
Rent expense under all operating leases totaled $590,000 and $900,000 for the years ended December
31, 2009 and 2008, respectively. The Company held no equipment acquired under capital leases as of
December 31, 2009. Equipment acquired under capital leases included in property and equipment as of
December 31, 2008 totaled $43,000 (net of accumulated amortization of $12,000) and amortization
expense associated with this equipment was included in depreciation and amortization expense.
The Company renewed certain of its liability insurance policies in March 2009 covering future
periods.
6. Restructuring Costs
In connection with the termination of the clinical trials for Riquent, the Company ceased all
manufacturing and regulatory activities related to Riquent and initiated steps to significantly
reduce its operating costs, including a reduction of force, resulting in the termination of 74
employees who received notification in February 2009 and were terminated in April 2009. The
Company recorded a charge of approximately $1,048,000 in the quarter ended March 31, 2009, of which
$668,000 was included in research and development and $380,000 was included in general and
administrative expense. The $1,048,000 was paid in May 2009.
On December 4, 2009, the Company entered into Retention and Separation Agreements and General
Release of All Claims (the Retention Agreements) with its two remaining officers (the Remaining
Officers). The Retention Agreements supersede the severance provisions of the employment
agreements with the Remaining Officers that were effective prior to the signing of the Retention
Agreements (the Prior Employment Agreements), but otherwise the terms of the Prior Employment
Agreements remain in full force and effect. The Retention Agreements do not alter the amount of
severance that was to be awarded under the Prior Employment Agreements, but rather changes the
event that trigger such payments.
Pursuant to the Retention Agreements, on December 18, 2009 the Company paid a total of $269,000,
less applicable withholding taxes, to the Remaining Officers (the Retention Payments). If the
Remaining Officers voluntarily resigned their employment prior to the earlier to occur of (a) the
closing of the Merger and (b) March 31, 2010, they were to immediately repay the Retention Payments to
the Company. The date under (a) and (b) shall be referred to as the Separation Date. The
unearned portion of the paid Retention Payments, including related employer taxes, of $222,000 was
deferred as of December 31, 2009.
Under the Retention Agreements, each of the Remaining Officers agreed to execute an amendment to
the Retention Agreements (the Amendment) on or about the Separation Date to extend and reaffirm
the promises and covenants made by them in the Retention Agreements
through the Separation Date. The Retention Agreements provided for
severance payments totaling $538,000, less applicable withholding
taxes (the Severance Payments) payable in a lump sum on the
eighth day after the Remaining Officers signed the
Amendment.
F-14
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
The earned portion of the Severance Payments, including related employer taxes, of $94,000 was
accrued as of December 31, 2009.
In
April 2010, the Compensation Committee of the Board confirmed
that pursuant to the terms of the Retention
Agreements, the Retention Payments and Severance Payments were earned as of March 31, 2010
and agreed that the existing employment terms would remain in effect beyond March 31,
2010. As an incentive to retain the current Named Executive Officers to pursue a strategic
transaction such as a merger, license agreement, third party collaboration or wind down of the
Company, the Compensation Committee also approved a retention bonus
for a total of up to approximately $600,000, depending on the type of strategic transaction completed.
7. Settlement of Liabilities
During the year ended December 31, 2009, the Company negotiated settlements related to accounts
payable obligations and accrued liabilities with a majority of its vendors. These negotiations
resulted in reductions to accounts payable obligations and accrued liabilities from those amounts
originally invoiced and accrued of approximately $2,743,000 for the year ended December 31, 2009,
which were recorded as expense reductions upon the execution of the settlement agreements. As a
result of these settlements, during the year ended December 31, 2009 there were decreases of
$2,597,000 and $146,000 to research and development and general and administrative expenses,
respectively.
In April 2009, the Company settled its notes payable obligations at face value. No notes payable
obligations exist as of December 31, 2009.
8. Stockholders Equity
Preferred Stock
As of December 31, 2009, the Companys Board of Directors is authorized to issue 8,000,000 shares
of preferred stock with a par value of $0.01 per share, in one or more series.
The
Companys Certificate of Designation filed with the Secretary of State of the State of Delaware designated 500,000 shares of preferred stock as nonredeemable Series A Junior
Participating Preferred Stock. These shares were potentially issuable
under the Companys Stockholder Rights Plan, which was terminated in September 2009.
Warrants
In connection with the December 2005 private placement, the Company issued warrants to purchase
4,399,992 shares of the Companys common stock. The warrants were immediately exercisable upon
grant, have an exercise price of $5.00 per share and remain exercisable for five years.
In connection with the May 2008 public offering, the Company issued warrants to purchase 3,903,708
shares of the Companys common stock. The warrants were immediately exercisable upon grant, have an
exercise price of $2.15 per share and remain exercisable for five years.
As of December 31, 2009, all of the warrants were outstanding and 8,303,700 shares of common stock
are reserved for issuance upon exercise of the warrants.
F-15
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
Stock Option Plans
In June 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(the 1994 Plan) under which, as amended, 1,640,000 shares of common stock (post-reverse
stock split) were authorized for issuance. The 1994 Plan expired in June 2004 and there were
474,504 options outstanding under the 1994 Plan as of December 31, 2009.
In May 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the 2004 Plan) under which, as amended, 6,400,000 shares of common stock (post-reverse
stock split) have been authorized for issuance. The 2004 Plan provides for the grant of incentive
and non-qualified stock options, as well as other share-based payment awards, to employees,
directors, consultants and advisors of the Company with up to a 10-year contractual life and
various vesting periods as determined by the Companys compensation committee or the board of
directors, as well as automatic fixed grants to non-employee directors of the Company. As of
December 31, 2009, there were a total of 3,034,063 options outstanding and 2,021,024 RSUs
outstanding. As of December 31, 2009, 1,065,694 shares remained available for future grant under
the 2004 Plan.
A summary of the Companys stock option activity and related data follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
Number of |
|
|
Average |
|
|
|
Shares |
|
|
Exercise Price |
|
Balance at December 31, 2007 |
|
|
4,809,576 |
|
|
$ |
8.56 |
|
Granted |
|
|
1,481,900 |
|
|
$ |
2.02 |
|
Exercised |
|
|
(1,097 |
) |
|
$ |
2.51 |
|
Forfeited /
Expired |
|
|
(663,418 |
) |
|
$ |
8.91 |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2008 |
|
|
5,626,961 |
|
|
$ |
6.80 |
|
Granted |
|
|
691,875 |
|
|
$ |
1.73 |
|
Forfeited /
Expired |
|
|
(2,810,268 |
) |
|
$ |
5.31 |
|
|
|
|
|
|
|
|
|
Balance at December 31, 2009 |
|
|
3,508,568 |
|
|
$ |
6.99 |
|
|
|
|
|
|
|
|
|
As of December 31, 2009, options exercisable have a weighted-average remaining contractual term of
6.0 years. No stock option exercises occurred during the year ended December 31, 2009. The total
intrinsic value of stock option exercises, which is the difference between the exercise price and
closing price of the Companys common stock on the date of exercise, during the year ended December
31, 2008 was $2,000. As of December 31, 2009 and 2008, the total intrinsic value, which is the
difference between the exercise price and closing price of the Companys common stock of options
outstanding and exercisable, was $0.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Years Ended December 31, |
|
|
|
2009 |
|
|
2008 |
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Exercise |
|
|
|
|
|
|
Exercise |
|
|
|
Options |
|
|
Price |
|
|
Options |
|
|
Price |
|
Exercisable at end of year |
|
|
3,175,233 |
|
|
$ |
7.47 |
|
|
|
3,522,747 |
|
|
$ |
9.08 |
|
Weighted-average fair
value of options granted
during the year |
|
$ |
1.72 |
|
|
|
|
|
|
$ |
1.70 |
|
|
|
|
|
F-16
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
Exercise prices and weighted-average remaining contractual lives for the options outstanding
(excluding shares of restricted stock) as of December 31, 2009 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Remaining |
|
|
Weighted- |
|
|
|
|
|
|
Exercise |
|
|
|
|
|
|
|
Contractual |
|
|
Average |
|
|
|
|
|
|
Price of |
|
Options |
|
|
Range of |
|
Life |
|
|
Exercise |
|
|
Options |
|
|
Options |
|
Outstanding |
|
|
Exercise Prices |
|
(in years) |
|
|
Price |
|
|
Exercisable |
|
|
Exercisable |
|
|
560,000 |
|
|
$0.64 $1.82 |
|
|
8.71 |
|
|
$ |
1.61 |
|
|
|
425,104 |
|
|
$ |
1.67 |
|
|
539,498 |
|
|
$1.87 $3.08 |
|
|
7.40 |
|
|
$ |
2.60 |
|
|
|
374,393 |
|
|
$ |
2.62 |
|
|
422,000 |
|
|
$3.23 $3.99 |
|
|
6.52 |
|
|
$ |
3.67 |
|
|
|
422,000 |
|
|
$ |
3.67 |
|
|
475,105 |
|
|
$4.20 $4.46 |
|
|
6.10 |
|
|
$ |
4.36 |
|
|
|
475,105 |
|
|
$ |
4.36 |
|
|
810,000 |
|
|
$5.26 |
|
|
6.20 |
|
|
$ |
5.26 |
|
|
|
776,666 |
|
|
$ |
5.26 |
|
|
356,094 |
|
|
$5.47 $18.75 |
|
|
4.67 |
|
|
$ |
11.11 |
|
|
|
356,094 |
|
|
$ |
11.11 |
|
|
262,872 |
|
|
$19.00 $35.25 |
|
|
2.24 |
|
|
$ |
27.56 |
|
|
|
262,872 |
|
|
$ |
27.56 |
|
|
15,999 |
|
|
$35.50 |
|
|
1.95 |
|
|
$ |
35.50 |
|
|
|
15,999 |
|
|
$ |
35.50 |
|
|
8,000 |
|
|
$36.75 |
|
|
1.13 |
|
|
$ |
36.75 |
|
|
|
8,000 |
|
|
$ |
36.75 |
|
|
58,999 |
|
|
$38.25 |
|
|
1.55 |
|
|
$ |
38.25 |
|
|
|
58,999 |
|
|
$ |
38.25 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
3,508,567 |
|
|
$0.64 $38.25 |
|
|
6.25 |
|
|
$ |
6.99 |
|
|
|
3,175,232 |
|
|
$ |
7.47 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
At December 31, 2009, the Company has reserved 4,574,261 shares of common stock for future issuance
upon exercise of options granted or to be granted under the 1994 and 2004 Plans.
Restricted Stock Units
Under the 2004 Plan, the Company granted 2,021,024 RSUs to the Companys three remaining employees
on December 31, 2009, where each RSU represents a contingent right to receive one share of the
Companys common stock. The RSUs were to vest upon the closing of the Merger, subject to the continued
employment of the recipient through the closing date of the Merger. As a result of the termination
of the Merger in March 2010, the RSUs were cancelled.
Stock-based compensation cost of RSUs is measured by the market value of the Companys common stock
on the date of grant. The grant date intrinsic value of awards granted is amortized on a
straight-line basis over the requisite service periods of the awards, which are the vesting
periods. The weighted average grant date intrinsic value was $0.17 per RSU. No stock-based
compensation expense related to these RSUs was recognized during 2009.
A summary of the Companys RSU activity and related data follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
|
|
|
|
Fair Value |
|
|
|
Shares |
|
|
per Share |
|
Restricted stock units outstanding at December 31, 2008 |
|
|
|
|
|
$ |
|
|
Granted |
|
|
2,021,024 |
|
|
$ |
0.17 |
|
|
|
|
|
|
|
|
Restricted stock units outstanding at December 31, 2009 |
|
|
2,021,024 |
|
|
$ |
0.17 |
|
As of December 31, 2009, 2,021,024 shares of common stock are reserved for issuance upon vesting of
the RSUs.
F-17
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
Employee Stock Purchase Plan
Effective August 1, 1995, the Company adopted the ESPP under which, as amended, 850,000 shares of
common stock are reserved for sale to eligible employees, as defined in the ESPP. Employees may
purchase common stock under the ESPP every three months (up to but not exceeding 10% of each
employees base salary, or hourly compensation, and any cash bonus paid, subject to certain
limitations) over the offering period at 85% of the fair market value of the common stock at
specified dates. The offering period may not exceed 24 months. No shares of common stock were
issued under the ESPP during the year ended December 31, 2009 and 303,937 shares of common stock
were issued under the ESPP during the year ended December 31, 2008. As of December 31, 2009,
833,023 shares of common stock have been issued under the ESPP and 16,977 shares of common stock
are available for future issuance.
|
|
|
|
|
|
|
Year Ended |
|
|
|
December 31, |
|
|
|
2008 |
|
Weighted-average fair value of Employee Stock Purchase Plan purchases |
|
$ |
0.71 |
|
Stockholder Rights Plan
The Company had adopted a Stockholder Rights Plan (the Rights Plan), which was amended
and restated in December 2008, subsequently amended in January 2009 and terminated in September
2009. Among other provisions, the Rights Plan provided for a dividend of one right (a
Right) to purchase fractions of shares of the Companys Series A Preferred Stock for each
share of the Companys common stock.
9. 401(k) Plan
The Company had a 401(k) defined contribution retirement plan (the 401(k) Plan), which
was terminated in March 2009. The Company did not match employee contributions or otherwise
contribute to the 401(k) Plan.
10. Income Taxes
The ASC Topic of Income Taxes prescribes a recognition threshold and measurement attribute criteria
for the financial statement recognition and measurement of tax positions taken or expected to be
taken in a tax return. For those benefits to be recognized, a tax position must be
more-likely-than-not to be sustained upon examination by taxing authorities. An uncertain income
tax position will not be recognized if it has less than a 50% likelihood of being sustained. There
were no unrecognized tax benefits as of the date of adoption. As of December 31, 2009 and 2008, the
total liability for unrecognized tax benefits was $45,000 and $0, respectively, and is included in
current liabilities.
A reconciliation of the beginning and ending amounts of unrecognized tax benefits is as follows (in
thousands):
|
|
|
|
|
|
|
Amount |
|
Unrecognized tax benefits balance at December 31, 2008 |
|
$ |
|
|
Increases related to current and prior year tax positions |
|
|
45 |
|
Settlements and lapses in statutes of limitations |
|
|
|
|
|
|
|
|
Unrecognized tax benefits balance at December 31, 2009 |
|
$ |
45 |
|
|
|
|
|
Included in the balance of unrecognized tax benefits at December 31, 2009 are $45,000 of tax
benefits that, if recognized, would affect the effective tax rate.
F-18
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
The Company is subject to taxation in the United States and various state jurisdictions. The
Companys tax years for 1995 and forward are subject to examination by the United States and
California tax authorities due to the carry forward of unutilized net operating losses and research
and development credits.
The Company has not completed its Section 382/383 analysis regarding the limitation of net
operating loss and research and development credit carryforwards. The Company does not presently
plan to complete its Section 382/383 analysis and unless and until this analysis has been
completed, the Company has removed the deferred tax assets for net operating losses and research
and development credits generated through 2009 from its deferred tax asset schedule and has
recorded a corresponding decrease to its valuation allowance.
At December 31, 2009, the Company had federal and California income tax net operating loss
carryforwards of approximately $360,563,000 and $223,465,000, respectively. The difference between
the federal and California tax loss carryforwards is primarily attributable to the capitalization
of research and development expenses for California income tax purposes. In addition, the Company
has federal and California research and development tax credit carryforwards of $16,372,000 and
$10,050,000, respectively. The federal net operating loss, research tax credit carryforwards and
California net operating loss carryforwards will begin to expire in 2010 unless previously
utilized. The California research and development credit carryforwards will carry forward
indefinitely until utilized. In February 2009, the Company experienced a change in ownership at a
time when its enterprise value was minimal. As a result of this ownership change and the low
enterprise value, the Companys federal and California net operating loss carryforwards and federal
research and development credit carryforwards as of December 31, 2009 will be subject to limitation
under IRC Section 382/383 and more likely than not will expire unused.
Significant components of the Companys deferred tax assets as of December 31, 2009 and 2008 are
listed below. A valuation allowance of $12,881,000 and $14,330,000 at December 31, 2009 and 2008,
respectively, has been recognized to offset the net deferred tax assets as realization of such
assets is uncertain. Amounts are shown in thousands as of December 31 of the respective years (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
Deferred tax assets: |
|
|
|
|
|
|
|
|
Net operating loss carryforwards |
|
$ |
|
|
|
$ |
|
|
Research and development credits |
|
|
|
|
|
|
|
|
Capitalized research and development and other |
|
|
12,881 |
|
|
|
14,330 |
|
|
|
|
|
|
|
|
Total deferred tax assets |
|
|
12,881 |
|
|
|
14,330 |
|
|
|
|
|
|
|
|
Net deferred tax assets |
|
|
12,881 |
|
|
|
14,330 |
|
Valuation allowance for deferred tax assets |
|
|
(12,881 |
) |
|
|
(14,330 |
) |
|
|
|
|
|
|
|
Net deferred taxes |
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
Income taxes computed by applying the U.S. Federal Statutory rates to income from continuing
operations before income taxes are reconciled to the provision for income taxes set forth in the
statement of operations as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
2009 |
|
|
2008 |
|
Tax benefit at statutory federal rate |
|
$ |
(3,022 |
) |
|
$ |
(21,999 |
) |
State tax benefit, net of federal |
|
|
(496 |
) |
|
|
(3,612 |
) |
Generation of research and development credits |
|
|
(347 |
) |
|
|
(1,461 |
) |
Expired tax attributes |
|
|
4,347 |
|
|
|
3,069 |
|
Removal of net operating losses and research
and development credits |
|
|
767 |
|
|
|
19,696 |
|
Stock compensation expense |
|
|
281 |
|
|
|
733 |
|
Other |
|
|
(81 |
) |
|
|
166 |
|
Change in valuation allowance |
|
|
(1,449 |
) |
|
|
3,408 |
|
|
|
|
|
|
|
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
F-19
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
11. Subsequent Events
On March 3, 2010, the Company and Adamis agreed to terminate the Merger Agreement as a result of
the failure of the Companys stockholders to vote in sufficient quantities for there to be a quorum
to hold the stockholders meeting to approve the proposals related to the Merger. The solicitation
of further votes was cancelled due to the Companys delisting from Nasdaq.
As a result of the termination of the Merger with Adamis, the RSUs granted in December 2009 were
cancelled in March 2010.
Effective at the open of business on March 4, 2010, the Companys common stock was suspended and
delisted from Nasdaq and began trading on The Pink OTC Markets, Inc. The delisting was the result
of Nasdaqs determination that the Company had nominal assets, other than cash, and had nominal
operations.
F-20
La Jolla Pharmaceutical Company
Notes to Consolidated Financial Statements
12. Selected Quarterly Financial Data (unaudited)
The following is a summary of the unaudited quarterly results of operations for the years ended
December 31, 2009 and 2008 (in thousands except per share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Quarters Ended |
|
|
|
Mar. 31, |
|
|
Jun. 30, |
|
|
Sept. 30, |
|
|
Dec. 31, |
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue from collaborative agreement: |
|
$ |
8,125 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
9,893 |
|
|
|
(85 |
) |
|
|
(240 |
) |
|
|
8 |
|
General and administrative |
|
|
2,487 |
|
|
|
2,124 |
|
|
|
992 |
|
|
|
1,590 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total expenses |
|
|
12,380 |
|
|
|
2,039 |
|
|
|
752 |
|
|
|
1,598 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(4,255 |
) |
|
|
(2,039 |
) |
|
|
(752 |
) |
|
|
(1,598 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income (expense), net |
|
|
3 |
|
|
|
(4 |
) |
|
|
54 |
|
|
|
(43 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(4,252 |
) |
|
$ |
(2,043 |
) |
|
$ |
(698 |
) |
|
$ |
(1,641 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.08 |
) |
|
$ |
(0.03 |
) |
|
$ |
(0.01 |
) |
|
$ |
(0.02 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share |
|
|
56,115 |
|
|
|
65,723 |
|
|
|
65,723 |
|
|
|
65,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2008 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
11,338 |
|
|
$ |
12,732 |
|
|
$ |
14,099 |
|
|
$ |
12,856 |
|
General and administrative |
|
|
1,906 |
|
|
|
2,069 |
|
|
|
2,791 |
|
|
|
2,936 |
|
Asset impairment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
2,810 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(13,244 |
) |
|
|
(14,801 |
) |
|
|
(16,890 |
) |
|
|
(18,602 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income (expense), net |
|
|
(393 |
) |
|
|
(134 |
) |
|
|
(244 |
) |
|
|
1,454 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(13,637 |
) |
|
$ |
(14,935 |
) |
|
$ |
(17,134 |
) |
|
$ |
(17,148 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.34 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.31 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing basic and diluted net loss per share |
|
|
39,631 |
|
|
|
48,252 |
|
|
|
55,327 |
|
|
|
55,423 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
F-21
EXHIBIT INDEX
|
|
|
|
|
Exhibit Number |
|
Description |
|
2.1 |
|
|
Agreement and Plan of Reorganization, by and among La Jolla
Pharmaceutical Company, Adamis Pharmaceuticals Corporation and Jewel
Merger Sub, Inc., dated as of December 4, 2009 (16) |
|
|
|
|
|
|
3.1 |
|
|
Restated Certificate of Incorporation (1) |
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3.2 |
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Amended and Restated Bylaws (2) |
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4.1 |
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Form of Common Stock Certificate (3) |
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10.1 |
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Form of Indemnification Agreement (4)* |
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10.2 |
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La Jolla Pharmaceutical Company 1994 Stock Incentive Plan (Amended and
Restated as of May 16, 2003) (5)* |
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10.3 |
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La Jolla Pharmaceutical Company 1995 Employee Stock Purchase Plan
(Amended and Restated as of June 20, 2008) (6)* |
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10.4 |
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La Jolla Pharmaceutical Company 2004 Equity Incentive Plan (Amended and
Restated as of June 20, 2008) (6)* |
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10.5 |
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Form of Option Grant under the La Jolla Pharmaceutical Company 2004
Equity Incentive Plan (6)* |
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10.6 |
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Amended and Restated Employment Agreement, dated February 23, 2006, by
and between the Company and Josefina Elchico (1)* |
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10.7 |
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Amended and Restated Employment Agreement, dated February 23, 2006, by
and between the Company and Gail Sloan (1)* |
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10.8 |
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Chief Executive Officer Employment Agreement, dated March 15, 2006, by
and between the Company and Deirdre Y. Gillespie, M.D. (7)* |
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10.9 |
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Employment Offer Letter, dated July 10, 2006 and executed July 14, 2006,
by and between the Company and Michael Tansey, M.D. (8)* |
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10.10 |
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Employment Agreement, dated December 4, 2006, by and between the Company
and Michael Tansey, M.D. (9)* |
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10.11 |
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Executive Employment Agreement, dated May 10, 2007, by and between the
Company and Niv Caviar (10)* |
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10.12 |
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First Amendment to Chief Executive Officer Employment Agreement, dated
July 31, 2007, by and between the Company and Deirdre Y. Gillespie (11)* |
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10.13 |
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Employment Offer Letter, dated March 4, 2008, by and between the Company
and Luke Seikkula (12)* |
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10.14 |
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Underwriting Agreement, dated as of May 6, 2008, between the Company and
UBS Securities, LLC and Canaccord Adams, Inc. (13) |
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10.15 |
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Form of Warrant Agreement (13) |
F-22
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Exhibit Number |
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Description |
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10.16 |
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Employment Offer Letter, dated March 4, 2008, by and between the Company
and Lisa Koch-Hulle (14)* |
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10.17 |
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First Amendment to Executive Employment Agreement, dated December 24,
2008, by and between the Company and Gail Sloan.(14)* |
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10.18 |
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First Amendment to Executive Officer Employment Agreement, dated December
24, 2008, by and between the Company and Niv Caviar.(14)* |
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10.19 |
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First Amendment to Employment Offer Letter, dated December 26, 2008, by
and between the Company and Vicki Motte.(14)* |
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10.20 |
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First Amendment to Employment Offer Letter, dated December 26, 2008, by
and between the Company and Luke Seikkula.(14)* |
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10.21 |
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First Amendment to Executive Employment Agreement, dated December 29,
2008, by and between the Company and Josefina Elchico.(14)* |
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10.22 |
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First Amendment to Employment Offer Letter, dated December 29, 2008, by
and between the Company and Lisa Koch-Hulle.(14)* |
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10.23 |
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First Amendment to Executive Employment Agreement, dated December 30,
2008, by and between the Company and Michael Tansey.(14)* |
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10.24 |
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Second Amendment to Chief Executive Officer Employment Agreement, dated
December 31, 2008, by and between the Company and Deirdre Gillespie.(14)* |
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10.25 |
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Development and Commercialization Agreement, dated as of January 4, 2009,
by and between the Company and BioMarin CF Limited (15) |
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10.26 |
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Securities Purchase Agreement, dated as of January 4, 2009, by and
between the Company and BioMarin Pharmaceutical Inc.(15) |
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10.27 |
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Amendment No. 1 to Development and Commercialization Agreement, dated as
of January 4, 2009, by and between the Company and BioMarin CF Limited
(15) |
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10.28 |
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Amendment No. 1 to Securities Purchase Agreement, dated as of January 4,
2009, by and between the Company and BioMarin Pharmaceutical Inc.(15) |
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10.29 |
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Retention and Separation Agreement and General Release of All Claims,
dated December 4, 2009, by and between the Company and Deirdre Y.
Gillespie, M.D. (16)* |
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10.30 |
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Retention and Separation Agreement and General Release of All Claims,
dated December 4, 2009, by and between the Company and Gail A. Sloan
(16)* |
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10.31 |
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Form of Voting Agreement (16) |
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21.1 |
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Subsidiaries of La Jolla Pharmaceutical Company ** |
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23.1 |
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Consent of Independent Registered Public Accounting Firm ** |
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31.1 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 ** |
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31.2 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 ** |
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32.1 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 ** |
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* |
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This exhibit is a management contract or compensatory plan or arrangement. |
F-23
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** |
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Filed herewith. |
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Confidential treatment for certain provisions of this exhibit. |
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(1) |
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Previously filed with the Companys Current Report on Form 8-K filed March 1, 2006 and
incorporated by reference herein. |
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(2) |
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Previously filed with the Companys Quarterly Report on Form 10-Q for the quarter ended
September 30, 2000 and incorporated by reference herein. |
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(3) |
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Previously filed with the Companys Registration Statement on Form S-3 (Registration No.
333-131246) filed January 24, 2006 and incorporated by reference herein. |
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(4) |
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Previously filed with the Companys Quarterly Report on Form 10-Q for the quarter ended
September 30, 2005 and incorporated by reference herein. |
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(5) |
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Previously filed with the Companys Quarterly Report on Form 10-Q for the quarter ended June
30, 2003 and incorporated by reference herein. |
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(6) |
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Previously filed with the Companys Registration Statement on Form S-8 (Registration No.
333-151825) filed June 20, 2008 and incorporated by reference herein. |
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(7) |
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Previously filed with the Companys Current Report on Form 8-K filed March 20, 2006 and
incorporated by reference herein. |
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(8) |
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Previously filed with the Companys Current Report on Form 8-K filed July 18, 2006 and
incorporated by reference herein. |
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(9) |
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Previously filed with the Companys Annual Report on Form 10-K for the fiscal year ended
December 31, 2006 and incorporated by reference herein. |
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(10) |
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Previously filed with the Companys Current Report on Form 8-K filed May 10, 2007 and
incorporated by reference herein. |
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(11) |
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Previously filed with the Companys Registration Statement on Form S-1 (Registration No.
33-76480) filed June 3, 1994 and incorporated by reference herein. |
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(12) |
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Previously filed with the Companys Current Report on Form 8-K filed March 4, 2008 and
incorporated by reference herein. |
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(13) |
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Previously filed with the Companys Current Report on Form 8-K filed May 7, 2008 and
incorporated by reference herein. |
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(14) |
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Previously filed with the Companys Annual Report on Form 10-K for the year ended December
31, 2008 and incorporated by reference herein. |
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(15) |
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Previously file with the Companys Quarterly Report on Form 10-Q for the quarter ended March
31, 2009 and incorporated by reference herein. |
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(16) |
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Previously filed with the Companys Current Report on Form 8-K filed on December 7, 2009 and
incorporated by reference herein. |
F-23