Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2010
OR
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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
(State or other jurisdiction of
incorporation or organization)
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33-0361285
(I.R.S. Employer
Identification No.) |
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4365 Executive Drive, Suite 300
San Diego, CA
(Address of principal executive offices)
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92121
(Zip Code) |
Registrants telephone number, including area code: (858) 452-6600
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 whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See definition 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 |
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 number of shares of the registrants common stock, $0.01 par value per share, outstanding at
May 3, 2010 was 65,722,648.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
2
PART I. FINANCIAL INFORMATION
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ITEM 1. |
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CONDENSED FINANCIAL STATEMENTS UNAUDITED |
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 31, |
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2010 |
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2009 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
3,627 |
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$ |
4,254 |
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Prepaids and other current assets |
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81 |
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586 |
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Total current assets |
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3,708 |
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4,840 |
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Total assets |
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$ |
3,708 |
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$ |
4,840 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
84 |
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$ |
125 |
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Accrued expenses |
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302 |
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323 |
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Accrued payroll and related expenses |
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647 |
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173 |
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Total current liabilities |
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1,033 |
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621 |
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Commitments |
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Stockholders equity: |
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Common stock |
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657 |
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657 |
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Additional paid-in capital |
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428,106 |
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427,883 |
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Accumulated deficit |
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(426,088 |
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(424,321 |
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Total stockholders equity |
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2,675 |
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4,219 |
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Total liabilities and stockholders equity |
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$ |
3,708 |
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$ |
4,840 |
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Note: |
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The condensed consolidated balance sheet at December 31, 2009 has been derived from the
audited consolidated financial statements as of that date but does not include all of the
information and disclosures required by U.S. generally accepted accounting principles. |
See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
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Three Months Ended |
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March 31, |
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2010 |
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2009 |
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Revenue from collaboration agreement |
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$ |
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$ |
8,125 |
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Expenses: |
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Research and development |
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9,893 |
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General and administrative |
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1,767 |
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2,487 |
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Total expenses |
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1,767 |
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12,380 |
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Loss from operations |
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(1,767 |
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(4,255 |
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Interest income |
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12 |
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Interest expense |
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(9 |
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Net loss |
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$ |
(1,767 |
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$ |
(4,252 |
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Basic and diluted net loss per share |
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$ |
(0.03 |
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$ |
(0.08 |
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Shares used in computing basic and diluted net
loss per share |
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65,723 |
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56,115 |
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See accompanying notes.
4
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Three Months Ended |
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March 31, |
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2010 |
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2009 |
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Operating activities: |
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Net loss |
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$ |
(1,767 |
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$ |
(4,252 |
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Adjustments to reconcile net loss to net cash used for
operating activities: |
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Depreciation and amortization |
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74 |
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Share-based compensation expense |
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223 |
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542 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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505 |
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(776 |
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Accounts payable |
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(41 |
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5,145 |
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Accrued clinical/regulatory expenses |
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(3,048 |
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Accrued expenses |
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(21 |
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(677 |
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Accrued payroll and related expenses |
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474 |
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281 |
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Net cash used for operating activities |
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(627 |
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(2,711 |
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Investing activities: |
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Sales of short-term investments |
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10,000 |
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Additions to property and equipment |
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(18 |
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Increase in patent costs and other assets |
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(3 |
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Net cash provided by investing activities |
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9,979 |
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Financing activities: |
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Net proceeds from issuance of preferred stock |
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6,810 |
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Payments on credit facility |
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(5,933 |
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Payments on obligations under notes payable |
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(27 |
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Payments on obligations under capital leases |
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(2 |
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Net cash provided by financing activities |
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848 |
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Net (decrease) increase in cash and cash equivalents |
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(627 |
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8,116 |
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Cash and cash equivalents at beginning of period |
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4,254 |
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9,447 |
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Cash and cash equivalents at end of period |
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$ |
3,627 |
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$ |
17,563 |
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See accompanying notes.
5
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
March 31, 2010
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company and its wholly-owned subsidiaries La Jolla Limited (dissolved in October 2009) and Jewel
Merger Sub, Inc. (the Company) have been prepared in accordance with U.S. generally accepted
accounting principles (GAAP) for interim financial information and with the instructions to Form
10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and
disclosures required by GAAP for complete financial statements. In the opinion of management, all
adjustments (consisting of normal recurring accruals and the restructuring costs see Note 6 for
further details) considered necessary for a fair presentation have been included. Operating results
for the three months ended March 31, 2010 are not necessarily indicative of the results that may be
expected for other quarters or the year ended December 31, 2010. For more complete financial
information, these unaudited condensed consolidated financial statements, and the notes thereto,
should be read in conjunction with the audited consolidated financial statements for the year ended
December 31, 2009 included in the Companys Form 10-K filed with the Securities and Exchange
Commission.
Following
the negative results of the
Riquent®
Phase
3 ASPEN trial that were received in February 2009, the Company recorded a
significant charge for the impairment of its Riquent assets, including the Riquent-related patents,
and the Company may not realize any significant value from the Riquent program in the future.
Additionally, although the Company has recently engaged consultants
to determine whether there is any potential for the further
development of Riquent, there is a substantial risk that Riquent may
not be a candidate for further development and the Company may not successfully enter into any strategic transactions, which may
include mergers, license agreements or third party collaborations to develop new products, or
potentially Riquent. Even if the Company determines to pursue one or more of these alternatives, it
may be unable to do so on acceptable terms. Any such transactions are likely to be highly dilutive
to the Companys existing stockholders and may deplete its limited remaining capital resources.
The Company has a history of recurring losses from operations and, as of March 31, 2010, the
Company had no revenue sources, an accumulated deficit of $426,088,000, and available cash and cash
equivalents of $3,627,000. These factors raise substantial doubt about the Companys ability to
continue as a going concern. The accompanying unaudited condensed 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 its liabilities in
the normal course of business and this 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.
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 of Riquent 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 completed a reduction in force in April 2009
(see Note 6).
6
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 The NASDAQ Stock Market
(Nasdaq).
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. and has since transitioned to
the OTC Bulletin Board.
In light of the Companys apparent inability to complete a strategic transaction that requires
stockholder approval, the Companys current business operations are focused on evaluating the
options available to the Company to maximize the value of its assets, which may include the
following:
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Sell or out-license the Riquent program, although the Company 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 the Company acquires
new compounds for development and seeks additional capital; |
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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; or |
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Raise additional capital from third parties to develop existing assets and/or acquire new
assets for development. |
2. Accounting Policies
Principles of Consolidation
The accompanying unaudited condensed 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 GAAP requires management to
make estimates and assumptions that affect the amounts reported in the unaudited condensed
consolidated financial statements and disclosures made in the accompanying notes to the unaudited
condensed consolidated financial statements. Actual results could differ materially from those
estimates.
Recent Accounting Pronouncements
There were no accounting pronouncements adopted by the Company or issued during the three months
ended March 31, 2010 that had a material effect on the unaudited condensed consolidated financial
statements or that are reasonably certain to have a material impact on the unaudited condensed
consolidated financial statements in future periods.
7
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.
The Companys sole source of revenue in the unaudited condensed consolidated financial statements
related to a January 4, 2009 Development Agreement with BioMarin CF, a wholly owned subsidiary of
BioMarin Pharmaceutical Inc. (BioMarin Pharma) 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 during the three months ended March 31, 2009.
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.
As a
result of the futility determination in the Riquent Phase 3 ASPEN trial, the Company discontinued the
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 for the year ended December 31, 2008 to
write down the value of the Companys patents, property and equipment and licenses to their
estimated fair values. 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.
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 March 31, 2010.
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.
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 EPS when their effect is dilutive.
8
Because the Company has incurred a net loss for both periods presented in the unaudited
condensed 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.
The following table shows the number of stock options and warrants that were excluded from the
calculation of EPS as of March 31, 2010 and 2009 because their
effect was anti-dilutive:
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March 31, |
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2010 |
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2009 |
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Stock options |
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3,430,471 |
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5,902,079 |
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Warrants |
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8,303,700 |
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8,303,700 |
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Total anti-dilutive shares |
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11,734,171 |
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14,205,779 |
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3. Cash and Cash Equivalents
As of March 31, 2010 and 2009, cash and cash equivalents were comprised of cash in checking
accounts.
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 the
Riquent Phase 3 ASPEN study 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.
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.
9
5. Stockholders Equity
Share-Based Compensation
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 were authorized for
issuance. The 1994 Plan expired in June 2004 and there were 411,408 options outstanding under the
1994 Plan as of March 31, 2010.
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 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 March 31, 2010, there were a total of 3,019,063
options outstanding under the 2004 Plan and 3,101,718 shares remained available for future grant.
In August 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (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. As of March 31, 2010, 833,023 shares of common stock have been issued under the
ESPP and 16,977 shares of common stock are available for future issuance.
Share-based compensation expense for the three-month periods ended March 31, 2010 and 2009 was
$223,000 and $542,000, respectively. As of March 31, 2010, there was $409,000 of total
unrecognized compensation cost related to non-vested share-based payment awards granted under all
equity compensation plans. Total unrecognized compensation cost will be adjusted for future changes
in estimated forfeitures. The Company expects to recognize this compensation cost over a
weighted-average period of 1.1 years.
The following table summarizes share-based compensation expense related to employee and director
stock options by expense category (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2010 |
|
|
2009 |
|
Research and development |
|
$ |
|
|
|
$ |
66 |
|
General and administrative |
|
|
223 |
|
|
|
476 |
|
|
|
|
|
|
|
|
Share-based compensation expense included in operating expenses |
|
$ |
223 |
|
|
$ |
542 |
|
|
|
|
|
|
|
|
The Company determines the fair value of share-based payment awards on the date of grant using the
Black-Scholes option-pricing model, which is affected by the Companys stock price as well as
assumptions regarding a number of highly complex and subjective variables. 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. Although the fair value of employee and director stock
options granted by the Company is determined using an option-pricing model, that value may not be
indicative of the fair value observed in a willing-buyer/willing-seller market transaction.
10
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:
|
|
|
|
|
|
|
March 31, |
|
|
|
2009 |
|
Options: |
|
|
|
|
Risk-free interest rate |
|
|
0.6 |
% |
Dividend yield |
|
|
0.0 |
% |
Volatility |
|
|
295.0 |
% |
Expected life (years) |
|
|
5.6 |
|
The weighted-average fair value of options granted was $1.72 for the three months ended March 31,
2009. There were no option grants during the three months ended March 31, 2010. There were no
purchases under the ESPP for the three months ended March 31, 2010 and 2009.
A summary of the Companys stock option activity and related data for the three months ended March
31, 2010 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Exercise |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2009 |
|
|
3,508,568 |
|
|
$ |
6.99 |
|
Granted |
|
|
|
|
|
$ |
|
|
Forfeited / Expired |
|
|
(78,097 |
) |
|
$ |
11.62 |
|
|
|
|
|
|
|
|
|
Balance at March 31, 2010 |
|
|
3,430,471 |
|
|
$ |
6.88 |
|
|
|
|
|
|
|
|
|
Restricted Stock Units
Under the 2004 Plan, the Company granted 2,021,024 restricted stock units (RSUs) to the Companys
three 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. Due to their
cancellation, no stock-based compensation expense related to the RSUs was recognized during the
three months ended March 31, 2010.
11
A summary of the Companys RSU activity and related data follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Number of |
|
|
Fair Value |
|
|
|
Shares |
|
|
per Share |
|
Restricted stock units outstanding at December 31, 2009 |
|
|
2,021,024 |
|
|
$ |
0.17 |
|
Cancelled |
|
|
(2,021,024 |
) |
|
$ |
0.17 |
|
|
|
|
|
|
|
|
|
Restricted stock units outstanding at March 31, 2010 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
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 Chief Executive Officer and Vice
President of Finance (the Officers). The Retention Agreements supersede the severance provisions
of the employment agreements with the 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 events that triggers 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 Officers (the Retention Payments). If the Officers were
to voluntarily resign their employment prior to the earlier to occur of (a) the closing of the
Merger with Adamis 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. Neither of
the Officers resigned prior to March 31, 2010 and the Merger never closed, so each Officer is
entitled to keep the full amount of her respective Retention Payment.
Under the Retention Agreements, each of the 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 Officers signed
the Amendment.
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.
The Retention Payments of $268,000 that were paid in December 2009 were fully earned as of March
31, 2010, of which $222,000 was charged to general and administrative expense for the quarter ended
March 31, 2010 and $46,000 was charged to general and administrative expense for the year ended
December 31, 2009. The fully-earned Severance Payments, including related employer taxes of
$550,000, were accrued as of March 31, 2010 and are expected to be paid during the second quarter
of 2010. Of the $550,000 that was accrued as of March 31, 2010, $456,000 was charged to general and
administrative expense for the quarter ended March 31, 2010 and $94,000 was charged to general and
administrative expense for the year ended December 31, 2009.
12
As an incentive to retain the Officers to pursue a strategic transaction such as a merger,
license agreement, financing, third party collaboration or wind down of the Company, the
Compensation Committee approved retention bonuses for a total of up to approximately $600,000,
depending on the type of strategic transaction completed.
7. Commitments and Contingencies
As of
March 31, 2010, there were no material operating leases, notes
payable, purchase commitments, or capital leases.
The Company renewed certain of its liability insurance policies in March 2010 covering future
periods.
In
January 2009, the amount outstanding on the credit facility of
$5,933,000 was settled in full
and the credit facility agreement was terminated.
|
|
|
ITEM 2. |
|
MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS |
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 our Annual Report on Form 10-K for the year ended December 31, 2009, and in other
reports and registration statements that we file with the Securities and Exchange Commission from
time to time and as updated in Part II, Item 1A. Risk Factors contained in this Quarterly Report
on Form 10-Q. We expressly disclaim any intent to update forward-looking statements.
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.
In light of our inability to complete a strategic transaction that requires stockholder
approval in the last year, our current business operations are focused on evaluating the options
available to us to maximize the value of our assets, which may include the following:
|
|
|
Sell or out-license our Riquent program, although we may not receive any
significant value upon such a sale or license; |
|
|
|
Pursue potential other strategic transactions, which could include
mergers, license agreements or other collaborations, with third
parties where we seek new compounds for development and seek
additional capital; |
|
|
|
Implement a wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company; or |
|
|
|
Raise additional capital from third parties to develop existing assets
and/or acquire new assets for development. |
13
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 our Riquent program in the future. Additionally, although we have
recently engaged consultants to determine whether there is any
potential for the further development of our Riquent program, there
is a substantial risk that Riquent may not be a candidate for further
development and we may not
successfully implement any of these strategic alternatives. 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
are likely to be highly dilutive to our existing stockholders and may deplete our limited remaining
capital resources.
Effective at the open of business on March 4, 2010, our common stock was suspended and
delisted from The NASDAQ Stock Market (Nasdaq) and began
trading on The Pink OTC Markets, Inc. and has since transitioned to
the OTC Bulletin Board.
The delisting was the result of Nasdaqs determination that the Company had nominal assets, other
than cash, and nominal operations.
Previously, in 2009, the following significant events had occurred:
|
|
|
In January 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) for which we received a
non-refundable commencement payment of $7.5 million pursuant to the Development
Agreement from BioMarin CF and $7.5 million from BioMarin Pharma in exchange for a
newly designated series of our preferred stock pursuant to the securities purchase
agreement. Following the futile results of the first interim efficacy analysis of
Riquent, the Development Agreement was terminated on March 27, 2009 and all of the
Companys Series B-1 preferred shares purchased by BioMarin Pharma were converted into
common shares. Additionally, all rights to Riquent were returned to us. |
|
|
|
In February 2009, an Independent Monitoring Board for the Riquent Phase 3 ASPEN
study informed us that, per its review of the first interim efficacy analysis of
Riquent, 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 and we significantly reduced our operating costs,
ceased all Riquent manufacturing and regulatory activities and completed a substantial
reduction in personnel in April 2009.
|
|
|
In October 2009, we attempted to obtain stockholder approval for a Plan of Complete
Liquidation and 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. |
|
|
|
In December 2009, 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). 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 the majority of our stockholders failed to return their proxy
cards or otherwise indicate their votes with respect to the proposals related to the
Merger. Accordingly, we were not able to obtain the requisite quorum to conduct
business at the special meeting. The solicitation of further votes was cancelled due
to the delisting of our common stock from Nasdaq. |
14
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with United States generally accepted accounting principles. The preparation of these unaudited
condensed 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.
There have been no material changes to the critical accounting policies as previously
disclosed in our Annual Report on Form 10-K for the year ended December 31, 2009.
Recent Accounting Pronouncements
There were no accounting pronouncements adopted by us or issued during the three months ended
March 31, 2010 that had a material effect on our unaudited condensed consolidated financial
statements or that are reasonably certain to have a material impact on the unaudited condensed
consolidated financial statements in future periods.
Results of Operations
For the three months ended March 31, 2010, revenue was zero compared to $8.1 million for the
same period in 2009. Revenue for the three months ended March 31, 2009 was 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 which
led to the recognition of previously deferred income on the nonrefundable payments received.
For the three months ended March 31, 2010, research and development expense decreased to zero
from $9.9 million for the same period in 2009 as a result of the discontinuation of the Riquent
Phase 3 ASPEN study.
For the three months ended March 31, 2010, general and administrative expense decreased to
$1.8 million from $2.5 million for the same period in 2009. This decrease is primarily the result
of decreases in consulting and legal expense of $0.6 million due to the BioMarin partnership that
occurred during the three months ended March 31, 2009. In addition, during April 2009, 10 general
and administrative personnel were terminated, resulting in decreases in salary and benefits and
stock-based compensation for the three months ended March 31, 2010 of $0.6 million. The decrease in
general and administrative expense for the three months ended March 31, 2010 was partially offset
by a $0.6 million increase in bonus expense recorded as of March 31, 2010 relating to retention
payments for our officers recorded as of March 31, 2010.
15
Interest expense and interest income, net, decreased to zero for the three months ended March
31, 2010, from less than $0.1 million for the same period in 2009. The decrease is due to the repayment of
our notes payable and capital leases during the quarter ended June 30, 2009 and moving all
short-term investments to non-interest bearing cash accounts during the quarter ended March 31,
2009.
Liquidity and Capital Resources
From inception through March 31, 2010, we have incurred a cumulative net loss of approximately
$426.1 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 March 31, 2010, we have raised approximately $410.8 million in
net proceeds from sales of equity securities.
At March 31, 2010, we had $3.6 million in cash as compared to $4.3 million of cash at December
31, 2009. Our working capital at March 31, 2010 was $2.7 million, as compared to $4.2 million at
December 31, 2009. The decrease in cash resulted from the use of our financial resources to fund
our general corporate operations.
Our
history of recurring losses from operations, our cumulative net loss
as of March 31, 2010 and the absence of any current revenue
sources raise substantial doubt about our ability to continue as a
going concern.
In 2009, we exited our former buildings upon the expiration of the leases, paid off all
remaining notes payable and capital lease obligations and early terminated our material operating
leases. As a result, no notes payable, purchase commitments, capital leases or material operating
leases existed as of March 31, 2010.
Our current business operations are focused on using our financial resources to fund our
current obligations and to assess the possible further development of Riquent as well as to pursue
strategic alternatives, as described above. 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:
|
|
|
our ability to sell, out-license or otherwise develop our Riquent
program; |
|
|
|
our ability to consummate a strategic transaction such as a merger,
license agreement or other collaboration with a third party; |
|
|
|
our implementation of a wind down of the Company if other alternatives
are not deemed viable and in the best interests of the Company; or |
|
|
|
our ability to raise capital from third parties to fund operations. |
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.
If we are successful in raising additional capital, any such offering is likely to be highly
dilutive to our existing investors and may transfer significant control to the new investors. See
Risk Factors below for additional information relating to the risks associated with any such
transaction.
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.
16
|
|
|
ITEM 4T. |
|
CONTROLS AND PROCEDURES |
Our management, with the participation of our principal executive officer and principal
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of
March 31, 2010. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, as amended (Exchange Act), means controls
and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the Securities and
Exchange Commissions rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by
a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the companys management, including its principal executive and principal financial
officers, as appropriate to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its
judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on
the evaluation of our disclosure controls and procedures as of March 31, 2010, our principal
executive officer and principal financial officer concluded that, as of such date, the Companys
disclosure controls and procedures were effective at the reasonable assurance level.
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) occurred during the quarter ended March 31, 2010 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
I. RISK FACTORS RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND THE INDUSTRY IN WHICH WE OPERATE.
The risk factors presented below update the risk factors previously disclosed in our Annual Report
on Form 10-K for the year ended December 31, 2009 (the Annual Report). The following factors,
along with those in the Annual Report and those described above under
Managements Discussion and
Analysis of Financial Condition and Results of Operations should be reviewed carefully, in
conjunction with the other information contained in this Report and our financial statements. These
factors, among others, could cause actual results to differ materially from those currently
anticipated and contained in forward-looking statements made in this Form 10-Q and presented
elsewhere by our management from time to time. See Part I, Item 2Forward-Looking Statements.
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, and if we are successful in raising
capital, it would likely be highly dilutive and result in the issuance of securities with special
rights, preferences and privileges.
As of
March 31, 2010, we had approximately $2.7 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.
17
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, redemption rights, liquidation preferences, anti-dilution adjustments, special
approval rights, and other terms that could provide new investors with superior economic rights
vis-à-vis the common stock as well as 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.
Although we are attempting to pursue potential strategic transactions, there is no assurance that
we will be successful and, even if we are successful, our stockholders may suffer dilution or other
reductions in value as part of our acquisition of new assets.
Following
the futility determination of the Riquent ASPEN study 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.
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. Given
our limited cash resources, we may choose to issue capital stock or debt securities to acquire
drugs or drug candidates for development or to fund development of existing assets. These
issuances may be highly dilutive to our existing stockholders. If we issue preferred stock as
consideration for any such acquisition or funding, these preferred shares will likely have special
rights, preferences and privileges that are superior to our common stock, which would further
reduce the value of our common stock.
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.
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. and have since moved to The OTC Bulletin Board (the OTC BB). As a
result of trading on the OTC BB, the market liquidity of our common stock may be adversely affected
as certain investors may not trade in securities that are quoted on the OTC BB due to
considerations including low price, illiquidity, and the absence of qualitative and quantitative
listing standards. For example, since being delisted from Nasdaq, we are no longer subject to the
Nasdaq listing standards, which included, among other things, that we seek stockholder approval for
certain extraordinary transactions, such as the issuance of more than 20% of our common stock at a
price that is below market. Accordingly, we are no longer required to obtain stockholder approval
for such transactions and may, under Delaware corporate law, effect transactions such as this
without prior notice and without stockholder approval.
18
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.
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 at
approximately $0.05 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:
|
|
limited financial resources; |
|
|
|
announcements regarding financings, mergers or other strategic transactions; |
|
|
|
future sales of significant amounts of our capital stock by us or our stockholders; |
|
|
|
developments in patent or other proprietary rights; |
|
|
|
developments concerning potential agreements with collaborators; and |
|
|
|
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.
19
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Exhibit |
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Number |
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Description |
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10.1 |
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Termination of Merger Agreement, dated as of March 3, 2010, by and
between the Company and Adamis Pharmaceuticals Corporation (1) |
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31.1 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
31.2 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
|
32.1 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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(1) |
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Filed as Exhibit 10.1 to the Companys Current Report on Form 8-K, filed with the
Securities and Exchange Commission on March 5, 2010 and incorporated herein by reference. |
20
SIGNATURES
Pursuant to the requirements 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.
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La Jolla Pharmaceutical Company
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Date: May 21, 2010 |
/s/ Deirdre Y. Gillespie
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Deirdre Y. Gillespie, M.D. |
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President and Chief Executive Officer
(On behalf of the Registrant) |
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/s/ Gail A. Sloan
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Gail A. Sloan |
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Vice President of Finance and Secretary
(As Principal Financial and Accounting Officer) |
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21