Form 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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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 June 30, 2010
OR
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o |
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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
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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4365 Executive Drive, Suite 300 |
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San Diego, CA
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92121 |
(Address of principal executive offices)
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(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, $0.01 par value per share, outstanding at
August 11, 2010 was 94,696,014.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except
share and par value amounts)
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June 30, |
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December 31, |
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2010 |
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2009 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
8,071 |
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$ |
4,254 |
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Prepaids and other current assets |
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150 |
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586 |
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Total current assets |
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8,221 |
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4,840 |
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Total assets |
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$ |
8,221 |
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$ |
4,840 |
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LIABILITIES,
REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS (DEFICIT) EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
87 |
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$ |
125 |
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Accrued expenses |
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328 |
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323 |
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Accrued payroll and related expenses |
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109 |
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173 |
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Derivative liabilities |
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8,103 |
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Total current liabilities |
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8,627 |
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621 |
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Series C-1 redeemable convertible preferred stock,
$0.01 par value; 11,000 shares authorized, 5,184 and no
shares issued and outstanding at June 30, 2010 and
December 31, 2009, respectively (redemption value and
liquidation preference in the aggregate of
$5,258 at June 30, 2010) |
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29 |
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Commitments |
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Stockholders (deficit) equity: |
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Common stock, $0.01 par value; 225,000,000 shares
authorized, 94,693,083 and 65,722,648 shares issued and
outstanding at June 30, 2010 and December 31, 2009 |
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947 |
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657 |
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Additional paid-in capital |
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427,810 |
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427,883 |
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Accumulated deficit |
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(429,192 |
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(424,321 |
) |
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Total stockholders (deficit) equity |
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(435 |
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4,219 |
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Total
liabilities, redeemable convertible preferred stock and stockholders (deficit) equity |
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$ |
8,221 |
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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.
1
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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Six Months Ended |
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June 30, |
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June 30, |
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2010 |
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2009 |
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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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$ |
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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 |
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(85 |
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9 |
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9,808 |
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General and administrative |
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901 |
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2,124 |
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2,667 |
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4,611 |
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Total expenses |
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910 |
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2,039 |
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2,676 |
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14,419 |
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Loss from operations |
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(910 |
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(2,039 |
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(2,676 |
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(6,294 |
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Other income (expense): |
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Fair value of derivative
liabilities upon issuance |
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(5,015 |
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(5,015 |
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Adjustments to fair value
of derivative liabilities |
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2,985 |
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2,985 |
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Financing transaction costs |
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(164 |
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(164 |
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Interest income and other
expense, net |
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(4 |
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(1 |
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(1 |
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Net loss |
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(3,104 |
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(2,043 |
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(4,871 |
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(6,295 |
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Preferred stock dividend |
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(87 |
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(87 |
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Net loss and comprehensive loss attributable to common stockholders |
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$ |
(3,191 |
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$ |
(2,043 |
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$ |
(4,958 |
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$ |
(6,295 |
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Basic and diluted net loss per
share |
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$ |
(0.04 |
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$ |
(0.03 |
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$ |
(0.07 |
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$ |
(0.10 |
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Shares used in computing basic
and diluted net loss per share |
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77,183 |
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65,723 |
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71,485 |
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60,945 |
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See accompanying notes.
2
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Six Months Ended |
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June 30, |
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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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$ |
(4,871 |
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$ |
(6,295 |
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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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110 |
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Gain on write-off/disposal of patents, property and equipment |
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(326 |
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Share-based compensation expense |
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304 |
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2,033 |
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Settlement of accounts payable and accrued liabilities |
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(1,880 |
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Issuance of
Series C-1 Preferred Stock for services |
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12 |
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Fair value of derivative liabilities upon issuance |
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5,015 |
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Gain on adjustments to fair value of derivative liabilities |
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(2,985 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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436 |
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(469 |
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Accounts
payable and accrued expenses |
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(33 |
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(4,045 |
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Accrued payroll and related expenses |
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(64 |
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(1,421 |
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Net cash used for operating activities |
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(2,186 |
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(12,293 |
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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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Net proceeds from sale of patents and property and equipment |
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836 |
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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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(6 |
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Net cash provided by investing activities |
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10,812 |
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Financing activities: |
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Proceeds from issuance of derivative obligations |
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6,003 |
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Net proceeds from issuance of Series B 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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(331 |
) |
Payments on obligations under capital leases |
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(3 |
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Net cash provided by financing activities |
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6,003 |
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543 |
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Net increase (decrease) in cash and cash equivalents |
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3,817 |
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(938 |
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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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$ |
8,071 |
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$ |
8,509 |
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Supplemental schedule of noncash investing and financing activities: |
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Issuance of common stock at par value, offset by paid-in capital reduction |
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290 |
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Accrued
dividends payable in Series C-1 Preferred Stock |
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87 |
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
June 30, 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 7 for
further details) considered necessary for a fair presentation have been included. Operating results
for the three and six months ended June 30, 2010 are not necessarily indicative of the results that
may be expected for other quarters within or for the year ending 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.
The Company has a history of recurring losses from operations and, as of June 30, 2010, the Company
had no revenue sources, an accumulated deficit of $429,192,000 and available cash and cash
equivalents of $8,071,000 of which up to $5,184,000, plus accrued dividends, could be required to
be paid upon the triggering of a redemption right under the Companys outstanding preferred
securities, which is not considered probable as of June 30, 2010 (see Note 5). 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.
Significant 2010 Events
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. and has since transitioned to
the OTC Bulletin Board.
In
May 2010, the Company entered into definitive agreements
principally with institutional investors and
affiliates for a private placement of common stock, redeemable convertible preferred stock and
warrants to purchase convertible preferred stock for initial proceeds of $6,003,000 (the May 2010
Financing). The Company expects to use a portion of the initial proceeds from the transaction to evaluate potential
pharmaceutical products for in-licensing or acquisition and/or to assess whether development
opportunities for Riquent exist, among other uses, with a majority of
the proceeds to be used for the consummation of a potential strategic transaction.
If the evaluation efforts do not culminate
in the consummation of a strategic transaction that is approved by at least two-thirds of the then-outstanding preferred stockholders,
such as a joint venture, partnership, development
agreement, license agreement or the further development of Riquent, with or without a third party
(a Strategic Transaction), within nine months of the
May 2010 Financing, then the Series C-1 convertible
preferred stock may be redeemed by the investors (see Note 5).
4
Pursuant to the terms of May 2010 Financing agreements, the Company sold 28,970,435 shares of the
Companys common stock, (the Common Stock), at a
contractually stated price of $0.03 per share and 5,134 shares of the
Companys Series C-1 Preferred Stock, (the Series C-1 Preferred), at a contractually stated price of $1,000 per share, which can be converted into 342 million shares of common stock, subject to certain limitations.
The purchasers also received warrants (the Series D-1 Warrants) to purchase 5,134 shares of the
Companys Series D-1 Preferred Stock, (the Series D-1 Preferred), at an exercise price of $1,000
per share, which warrants may be exercised on a net or
cashless basis. Additionally, the purchasers received warrants (the Series C-2 Warrants) to purchase 10,268 units, at an exercise price of
$1,000 per unit, which warrants are exercisable only in cash, with each unit consisting of one share
of the Companys Series C-2 Preferred Stock, (the Series C-2 Preferred), and an additional
warrant (the Series D-2 Warrant) to purchase one share of the Companys Series D-2 Preferred
Stock, (the Series D-2 Preferred), at an exercise
price of $1,000 per share. The Series D-1
Warrants, Series C-2 Warrants and Series D-2 Warrants are collectively referred to as the
Warrants. The Series C-1 Preferred, Series C-2 Preferred, Series D-1 Preferred and Series D-2
Preferred are convertible and the Series C-1 Preferred and Series C-2 Preferred are redeemable, if and when issued, and are collectively referred to as the Preferred Stock.
The Common Stock, Preferred Stock and Warrants are referred to collectively as the Securities.
In a separate transaction on May 26, 2010, the Company issued approximately 50 shares of Series C-1 Preferred to one of the
purchasers in the May 2010 Financing in exchange for a first right of negotiation for a product
candidate.
Significant 2009 Events
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 to potentially develop
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.
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 7).
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. and Adamis Pharmaceuticals Corporation
(Adamis). The transaction contemplated by the Merger Agreement was structured as a reverse
merger, in which Jewel Merger Sub, Inc., 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
submit their 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 on March 4, 2010.
5
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 Standards Updates adopted by the Company or issued during the six months
ended June 30, 2010 that had a material effect on the unaudited condensed consolidated financial
statements.
Revenue Recognition
The Company applies the revenue recognition criteria outlined in the ASC Topic on 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
for the six months ended June 30, 2009 is 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 quarter 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 in February 2009, 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 the majority of its remaining long-lived assets during
the six months ended June 30, 2009.
6
Accrued Clinical/Regulatory Expenses
As a result of the discontinuation of the Riquent Phase 3 ASPEN study and the development of
Riquent in February 2009, all clinical and regulatory activities were ceased and no related accruals were required
as of June 30, 2009 and no further clinical or regulatory activities
have occurred subsequently and through June 30, 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 stock equivalents. Diluted EPS is computed by dividing the net
income or loss by the weighted-average
number of common stock equivalents outstanding for the period
determined using the treasury-stock method. For purposes of this calculation, common stock issuable upon the conversion of preferred stock and exercise
of 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.
The shares used to compute basic and diluted net loss per share represent the weighted-average common shares outstanding.
Because
the Company has incurred a net loss for all periods presented in the unaudited condensed
consolidated statements of operations, common stock issuable upon the conversion of preferred stock
and the exercise of stock options and warrants are not included in the computation of net loss per
share because their effect is anti-dilutive. At June 30, 2010 and 2009, the potentially dilutive
securities include 2.1 billion and 13.0 million shares, respectively, reserved for the conversion
of convertible preferred stock, including accrued dividends, and the exercise of outstanding
stock options and warrants. Of the potentially dilutive convertible
preferred stock, 342 million potentially dilutive common shares
relate to presently issued and outstanding shares of preferred stock.
Derivative Liabilities
In
conjunction with the May 2010 Financing, the Company issued
redeemable convertible preferred stock that contain certained certain embedded derivative features, as well
as warrants that are accounted for as derivative liabilities (see Note 5). These derivative
liabilities were determined to be ineligible for equity classification due to provisions of the
underlying preferred stock, which is also ineligible for equity classification, whereby redemption
is outside the sole control of the Company and provisions exist that may result in an adjustment to
their exercise or conversion price.
The Companys derivative liabilities are recorded at their estimated fair value on the date of
issuance and will be adjusted to reflect the estimated fair value at each period end, with any increase or
decrease in the estimated fair value being recorded as other income or expense. The fair value of
these liabilities is estimated using option pricing models that are based on the individual
characteristics of the common stock and preferred stock, the derivative liability on the valuation date, as well as
assumptions for expected volatility, expected life and risk-free interest rate.
7
3. Fair Value of Financial Instruments
Financial assets and liabilities are measured at fair value, which is defined 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 must
maximize the use of observable inputs and minimize the use of unobservable inputs. The following is
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:
|
|
|
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. |
In
conjunction with the May 2010 Financing, the Company issued
redeemable convertible preferred stock with certain embedded derivative features, as well as
warrants to purchase various types of convertible preferred stock and units. These instruments are
accounted for as derivative liabilities (see Note 5).
The
Company used Level 3 inputs for its valuation methodology for the
embedded derivative liabilities and warrant derivative liabilities. The estimated fair values were determined
using a binomial option pricing model based on various assumptions (see Note 5). The Companys
derivative liabilities are adjusted to reflect estimated fair value at each period end, with any
increase or decrease in the estimated fair value being recorded in results of operations as adjustments to
fair value of derivative liabilities.
At
June 30, 2010, the estimated fair values of the liabilities measured on a recurring basis are as follows
(in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at June 30, 2010 |
|
|
|
Balance at |
|
|
Quoted Prices in |
|
|
Significant Other |
|
|
Significant |
|
|
|
June 30, |
|
|
Active Markets |
|
|
Observable Inputs |
|
|
Unobservable Inputs |
|
|
|
2010 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Embedded derivative
liabilities |
|
$ |
4,895 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
4,895 |
|
Warrant derivative liabilities |
|
|
3,208 |
|
|
|
|
|
|
|
|
|
|
|
3,208 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
8,103 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
8,103 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
8
The
following table presents the activity for liabilities measured at
estimated fair value using unobservable
inputs for the six months ended June 30, 2010 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Embedded Derivative |
|
|
Warrant Derivative |
|
|
|
|
|
|
Liabilities |
|
|
Liabilities |
|
|
Total |
|
Beginning balance at December 31, 2009 |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
Issuances |
|
|
5,524 |
|
|
|
5,494 |
|
|
|
11,018 |
|
Adjustments to estimated fair value |
|
|
(699 |
) |
|
|
(2,286 |
) |
|
|
(2,985 |
) |
Accrued
dividends payable in Series C-1 Preferred |
|
|
70 |
|
|
|
|
|
|
|
70 |
|
Transfers into Level 3 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance at June 30, 2010 |
|
$ |
4,895 |
|
|
$ |
3,208 |
|
|
$ |
8,103 |
|
|
|
|
|
|
|
|
|
|
|
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
certain countries, and the non-exclusive right to manufacture Riquent anywhere in the world. This
agreement was terminated in March 2009.
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. Securities Purchase Agreement
On May 24, 2010, the Company entered into a Securities Purchase Agreement (the Purchase
Agreement) by and among the Company and the purchasers named
therein (the Purchasers). The Purchasers included
institutional investors as well as the Companys Chief Executive
Officer, Chief Financial Officer and an additional employee. The
total investment by these Company employees represented less than 3%
of the proceeds received by the Company in the May 2010
Financing. Pursuant
to the Purchase Agreement, on May 26, 2010 (the Closing
Date or Closing), for total consideration of $6,003,000, the
Purchasers purchased (i) an aggregate of 28,970,435 shares of the Companys Common Stock, par value
$0.01 per share, at a contractually stated price of $0.03 per share, and (ii) 5,134 shares of the Companys Series C-1
Preferred, par value $0.01 per share, at a contractually stated price of $1,000 per share. The Purchasers also received
(i) Series D-1 Warrants to purchase 5,134 shares of the
Companys Series D-1 Preferred, par value $0.01 per share, at an exercise price of $1,000 per
share, which warrants may be exercised on a cashless basis, and (ii) Series C-2 Warrants to
purchase 10,268 units, at an exercise price of $1,000 per unit, which
warrants are exercisable only in
cash, with each unit consisting of one share of the Companys Series C-2 Preferred, par value $0.01
per share, and an additional Series D-2 Warrant to purchase one share of the Companys Series D-2
Preferred, par value $0.01 per share, at an exercise price of $1,000
per share which warrants may be exercised on a cashless basis. All shares of preferred stock are convertible into common
stock as described later herein.
At the Annual Meeting of Stockholders held on August 12, 2010, the Companys stockholders approved
a decrease to the par value of the Companys capital stock from $0.01 to $0.0001, with no
accounting consequences as of June 30, 2010.
Allocation of Proceeds
At the
Closing Date, the estimated fair value of the Series C-2
Warrants for units, Series D-1 Warrants, and
the embedded derivatives included within the Series C-1 Preferred exceeded the proceeds from the
May 2010 Financing of $6,003,000 (see the valuations of these derivative liabilities under the heading, Derivative Liabilities, below). As a
result, all of the proceeds were allocated to these derivative liabilities and no proceeds remained
for allocation to the Common Stock and Series C-1 Preferred issued in the financing.
Common Stock
The Purchasers are restricted from selling the Common Stock until six months after the Closing Date
and, as of June 30, 2010, the Common Stock is unregistered.
Accounting Treatment
At the Closing Date, the Company issued 28,970,435 shares of Common Stock and recorded the par
value of the shares issued of $290,000 with a corresponding reduction to paid-in capital, given
that there was no allocated value from the proceeds to the Common Stock.
Redeemable Preferred Stock
As of June 30, 2010, 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, of which 11,000 are designated for Series C-1 Preferred. As of June 30, 2010,
5,184 shares of Series C-1 Preferred Stock are issued and outstanding.
Voting Rights
The holders of Preferred Stock do not have voting rights other than for general protective rights
required by the Delaware General Corporation Law or as set forth below.
Dividends
Cumulative dividends are payable on the Series C-1 Preferred and Series C-2 Preferred, (if and when
issued) (together referred to herein as the Series C Preferred) at an annual rate of 15% from the
date of issuance through the date of conversion or redemption, payable semi-annually in shares of
Series C-1 Preferred and Series C-2 Preferred, respectively. There is no limit to the number of
shares of Series C Preferred that may be issued as dividends. Neither the Series D-1 Preferred nor
the Series D-2 Preferred (if and when issued) is entitled to dividends.
10
Conversion Rights
The Preferred Stock is convertible into common stock, initially at a rate of 66,667 shares of
common stock for each share of Preferred Stock, subject to certain limitations discussed below, at
the election of the holders of Preferred Stock. The conversion rate will be adjusted for certain
events, such as stock splits, stock dividends, reclassifications and recapitalizations, and is
subject to full-ratchet anti-dilution protection such that if the Company issues or grants any
warrants, rights, options to subscribe or purchase Common Stock or Common Stock Equivalents (the
Options) and the price per share for which the Common Stock issuable upon the exercise of such
Options is below the effective conversion price of the Preferred Stock at the time of such
issuance, then the conversion rate of the Preferred Stock automatically adjusts to increase the number of common shares into which it can convert. There are also limits on the amount of Preferred Stock that can be converted and the timing
of such conversions. The Series C-1 Preferred and Series D-1 Preferred (if and when issued from the
exercise of the related Series D-1 Warrants) may not be converted until at least six months and one
week following Closing. Thereafter, the Series C-1 Preferred and Series D-1 Preferred become
convertible at the rate of 2.5% of the face amount of such shares per week (with such amounts being
cumulative to the extent not exercised) over the following forty weeks. The Series C-2 Preferred
and Series D-2 Preferred may not be converted by any Purchaser until at least six months following
the first exercise of a Series C-2 Warrant by such Purchaser. Thereafter, the Series C-2 Preferred
and Series D-2 Preferred become convertible by such Purchaser at the rate of 2.5% of the face
amount of such shares per week (with such amounts being cumulative to the extent not exercised)
over the following forty weeks. Moreover, holders of Preferred Stock may not convert if such
conversion would result in the holder or any of its affiliates beneficially owning more than 9.999%
of the Companys then issued and outstanding shares of common stock. As of June 30, 2010, stockholders holding approximately 97% of the Series C-1 Preferred
represent three groups who are each at or very near this limit.
Upon certain redemption events, such as the Companys breach of covenants or material
representations or warranties under the Purchase Agreement, the conversion price of the Preferred
Stock decreases to 10% of the conversion price in effect immediately
before such redemption event thereby increasing the number of common
shares that would be issued for each share of Preferred Stock by a
factor of ten times.
Liquidation Preference
Upon a Liquidation Event (as defined in the certificate of designations for the Preferred Stock
(the Certificate of Designations)), no other class or series of capital stock can receive any
payment unless the Preferred Stock has first received a payment in an amount equal to $1,000 per
share, plus all accrued and unpaid dividends, if applicable.
Redemption Rights
In the event that certain actions occur without the waiver or prior written consent of the holders
of two-thirds of the then outstanding shares of Preferred Stock (the Requisite Holders), such as
the Companys material breach of any material representation or warranty under the Purchase
Agreement, a suspension of the trading of the Companys common stock, the failure to timely deliver
shares on conversion of the Preferred Stock, bankruptcy reorganization or the consummation of a
Change of Control (as defined in the Certificate of Designations) among others, then the holders of
the Series C Preferred shall have the right, upon the delivery of a notice to the Company by the
Requisite Holders, to have such shares redeemed by the Company for an amount equal to the greater
of $1,000 per share, plus accrued and unpaid dividends, or the fair market value of the underlying
common stock issuable upon conversion of the Series C Preferred.
If the Company fails to consummate a Strategic Transaction (as defined in the Certificate of
Designations) within nine months of the May 26, 2010 Closing, then the Series C Preferred may
thereafter be redeemed upon the demand of the Requisite Holders. The redemption price would be
equal to $1,000 per share, plus accrued and unpaid dividends. This redemption feature terminates
upon the consummation of a Strategic Transaction, which must be first approved by the Requisite
Holders. The Requisite Holders may also waive this redemption feature in the event
the Company does not consummate a Strategic Transaction within nine months of Closing. Moreover, if
the Requisite Holders fail to demand redemption of the Series C Preferred within two years from the
date of a Redemption Event (as defined in the Certificate of Designations), then the redemption
rights with respect to such Redemption Event shall be irrevocably waived by the preferred
stockholders.
11
Restrictions
So long as at least 1,000 shares of Preferred Stock remain outstanding (or at least 3,000 shares of
Preferred Stock remain outstanding if the Series C-2 Warrants have been exercised), the Company may
not take a variety of actions (such as altering the rights, powers, preferences or privileges of
the Preferred Stock so as to effect the Preferred Stock adversely, amending any provision of the
Companys certificate of incorporation, entering into an agreement for a Strategic Transaction or
Change of Control, consummating any financing or filing a registration statement with the
Securities and Exchange Commission, or SEC) without the prior approval of the Requisite Holders.
In addition, for so long as at least 1,000 shares of Preferred Stock remain outstanding and no
Strategic Transaction has been consummated, the Company has agreed to certain limitations on its spending
per month based on predetermined budgeted amounts.
Accounting Treatment
At the Closing Date, the Company issued 5,134 shares of Series C-1 Preferred and recorded the par
value of $0.01 per share with a corresponding reduction to paid-in capital, given that there was no
allocated value from the proceeds to the Series C-1 Preferred. As of June 30, 2010, the outstanding
Series C-1 Preferred issued at the Closing is convertible into 342 million shares of common stock.
As of June 30, 2010, the Company did not have a sufficient number of shares of common stock
authorized to satisfy its obligations upon conversion of the Series C-1 Preferred. Accordingly,
the Company sought stockholder approval to increase the number of shares of common stock authorized
to be issued under its certificate of incorporation. At the Annual Meeting of Stockholders held on
August 12, 2010, the Companys stockholders approved an increase in the number of shares of common
stock authorized for issuance from 225 million shares to 6 billion shares.
Under accounting guidance covering accounting for redeemable equity instruments, preferred
securities that are redeemable for cash or other assets are to be classified outside of permanent
equity (within the mezzanine section between liabilities and equity on the condensed consolidated
balance sheets) if they are redeemable at the option of the holder or upon the occurrence of an
event that is not solely within the control of the issuer. As there are redemption-triggering
events related to the Series C Preferred that are not solely within the control of the Company, the
Series C-1 Preferred was classified outside of permanent equity.
The
Company may be required to redeem the Series C-1 Preferred if a
redemption event occurs, such as the failure to consummate a
Strategic Transaction within nine months of Closing. Should
a redemption event become probable, the Company
will accrete the redemption value (plus accrued but unpaid dividends)
over the period remaining until the expected redemption date using
the effective interest method. The Company is not presently required to adjust the carrying value of the Series C-1 Preferred to
the redemption value of such shares as of June 30, 2010.
Series C-1 Preferred dividends are accrued to paid-in-capital in the period incurred at an annual
rate of 15%. The Company recorded accrued dividends on the Series C-1 Preferred of $18,000 as of
June 30, 2010, which consist of 74 shares of Series C-1 Preferred, or approximately 0.01 dividend
shares per Series C-1 Preferred share outstanding, convertible into 4.9 million shares of common
stock.
In a separate transaction, in exchange for a first right of negotiation for a product candidate,
the Company issued approximately 50 shares of Series C-1 Preferred convertible into 3.3 million
shares of the Companys common stock to a Purchaser on May 26, 2010. Using the present value of the
face amount of the Series C-1 Preferred, these shares were
valued at $12,000 and were fully charged to general and administrative expense during the three
months ended June 30, 2010.
12
Derivative Liabilities
The
Series C-1 Preferred and the underlying securities of the Series C-2 Warrants for units and the
Series D-1 Warrants (Series C Preferred and Series D Preferred) contain conversion features. In addition, the Series C-1
Preferred and the underlying securities of the Series C-2
Warrants for units (Series C Preferred) are subject
to redemption provisions that are
outside of the control of the Company.
The Series C-2 Warrants and Series D-1 Warrants are exercisable starting on the issuance date and
expire in three years from the date of issuance. The Series C-2 Warrants must be exercised in cash
upon the consummation of a Strategic Transaction and, if the Series C-2 Warrants are not timely
exercised as required, penalties and interest will accrue on the sums due to the Company under such
Series C-2 Warrants. The Series D-1 Warrants may be exercised on a cashless basis.
Accounting Treatment
The Company accounted for the conversion and
redemption features embedded in the Series C-1 Preferred (the Embedded Derivatives) in accordance
with accounting guidance covering derivatives. Companies may be required to bifurcate
conversion and redemption features embedded in redeemable convertible preferred stock from their
host instruments and account for these embedded derivatives as free standing derivative financial
instruments. If the underlying security of the embedded derivative requires net cash
settlement in the event of circumstances that are not solely within the Companys control, the
embedded derivative should be classified as a liability, measured at fair value at
issuance and marked to market at each period. As there are redemption triggering events for
Series C Preferred that are not solely within the Companys control, the Embedded
Derivatives are classified as liabilities and will
be accounted for using mark to market accounting at each reporting date.
The
Company accounted for the Series C-2 Warrants for units and Series D-1 Warrants
in accordance with accounting guidance covering derivatives. If the
underlying security of the warrant a) requires net cash settlement in
the event of circumstances that are not solely within the
Companys control or if not, if they are b) not indexed to our own stock, the warrants should be classified as
liabilities, measured at fair value at issuance and marked to market
at each period. As there are redemption triggering events for Series
C Preferred that are not solely within the
Companys control and the Series D Preferred are not indexed to our own stock, the Series C-2 Warrants and Series D-1
Warrants are classified as liabilities and will be accounted for
using mark-to-market accounting at each reporting date. The Embedded
Derivatives, Series C-2 Warrants and Series D-1 Warrants are
collectively referred to as the Derivative Liabilities.
The estimated fair values of the Derivative Liabilities as of the Closing Date and June 30, 2010 is
summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at |
|
|
|
May 26, 2010 |
|
|
June 30, 2010 |
|
Embedded Derivatives of Series C-1 Preferred |
|
$ |
5,524 |
|
|
$ |
4,825 |
|
Embedded
Derivatives of accrued dividends payable in Series C-1
Preferred |
|
|
|
|
|
|
70 |
|
Series D-1 Warrants |
|
|
815 |
|
|
|
497 |
|
Series C-2 Warrants for: |
|
|
|
|
|
|
|
|
Series C-2 Preferred |
|
|
3,049 |
|
|
|
1,717 |
|
Series D-2 Warrants |
|
|
1,630 |
|
|
|
994 |
|
|
|
|
|
|
|
|
|
|
$ |
11,018 |
|
|
$ |
8,103 |
|
|
|
|
|
|
|
|
Given that the fair value of the Derivative Liabilities exceeded the total proceeds at Closing, no
net amounts were allocated to the Series C-1 Preferred or the Common Stock. The amount by which the
recorded liabilities exceeded the proceeds has been charged to other expense at the Closing Date.
13
The
Derivative Liabilities were valued using binomial option pricing
models with various assumptions, detailed below. Due
principally to the six month trading restriction on the unregistered
shares of common stock issued or issuable from the conversion of Preferred Stock, the 2.5% per week conversion limitation on
Preferred Stock for 40 weeks, and the 9.999% common stock ownership
limitation imposed by the Purchase Agreement, as well as the uncertainty of
the Companys ability to continue as a going concern, the price per share of the Companys common stock used in the binomial
option pricing models for the Derivative Liabilities was discounted from the closing market prices
of $0.061 and $0.046 on the Closing Date and June 30, 2010,
respectively. The expected lives that were used to value each of the
Derivative Liabilities were based on the individual characteristics of
the underlying Preferred Stock, which impact the expected timing of
conversion into common stock.
On the Closing Date, the Embedded Derivatives were recorded at an estimated fair value of
$5,524,000, primarily related to the conversion feature of the Series C-1 Preferred. This value
includes the estimated fair value of $53,000 for the Embedded Derivatives of 50 shares of Series
C-1 Preferred issued in exchange for a first right of negotiation for
a product candidate on May 26, 2010. On June 30, 2010, the
Embedded Derivatives, including the estimated fair value of Embedded
Derivatives related to the accrued dividends payable in Series C-1 Preferred of $70,000, were revalued at $4,895,000,
resulting in other income on the decrease in the estimated fair value of the Embedded Derivatives
of $699,000.
The
Embedded Derivatives were valued at the Closing Date and at June 30, 2010 using a binomial
option pricing model, based on the value of the Series C-1 Preferred
shares with and without embedded derivative features, with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
May 26, 2010 |
|
|
June 30, 2010 |
|
Closing
price per share of common stock |
|
$ |
0.061 |
|
|
$ |
0.046 |
|
Estimated fair value per
share of common stock
(after related discounts) |
|
$ |
0.010 |
|
|
$ |
0.007 |
|
Conversion price per share |
|
$ |
0.015 |
|
|
$ |
0.015 |
|
Volatility |
|
|
109.2 |
% |
|
|
109.2 |
% |
Risk-free interest rate |
|
|
2.68 |
% |
|
|
2.42 |
% |
Credit spread |
|
|
17.3 |
% |
|
|
17.6 |
% |
Remaining
expected lives of underlying securities (years) |
|
|
6.9 |
|
|
|
6.8 |
|
On the
Closing Date, the Series D-1 Warrants were recorded at estimated fair value of
$815,000. On June 30, 2010, the Series D-1 Warrants were revalued at $497,000, resulting in other
income on the decrease in the estimated fair value of the Series D-1 Warrants of $318,000.
The Series D-1 Warrants were valued at the Closing Date and at June 30, 2010 using a binomial
option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
May 26, 2010 |
|
|
June 30, 2010 |
|
Closing
price per share of common stock |
|
$ |
0.061 |
|
|
$ |
0.046 |
|
Estimated fair value per
share of common stock
(after related discounts) |
|
$ |
0.010 |
|
|
$ |
0.007 |
|
Conversion price per share |
|
$ |
0.015 |
|
|
$ |
0.015 |
|
Volatility |
|
|
84.4 |
% |
|
|
84.4 |
% |
Risk-free interest rate |
|
|
1.28 |
% |
|
|
1.00 |
% |
Remaining
expected lives of underlying securities (years) |
|
|
3.3 |
|
|
|
3.3 |
|
On the
Closing Date, the Series C-2 Warrants (which consist of rights to
purchase Series C-2 Preferred and Series D-2 Warrants) were
recorded at an estimated fair value of $4,679,000. On June 30,
2010, the Series C-2 Warrants were revalued at
$2,711,000, resulting in other income on the decrease in the estimated fair value of Series C-2 Warrants of
$1,968,000.
14
The
portion of the Series C-2 Warrants that represent the rights to purchase
Series C-2 Preferred were valued using a binomial option pricing model, discounted for the lack of dividends
until the Series C-2 Warrants are exercised, with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
May 26, 2010 |
|
|
June 30, 2010 |
|
Closing
price per share of common stock |
|
$ |
0.061 |
|
|
$ |
0.046 |
|
Estimated fair value per
share of common stock
(after related discounts) |
|
$ |
0.010 |
|
|
$ |
0.007 |
|
Conversion price per share |
|
$ |
0.015 |
|
|
$ |
0.015 |
|
Volatility |
|
|
109.2 |
% |
|
|
109.2 |
% |
Risk-free interest rate |
|
|
2.68 |
% |
|
|
2.42 |
% |
Credit spread |
|
|
17.3 |
% |
|
|
17.6 |
% |
Remaining
expected lives of underlying securities (years) |
|
|
6.9 |
|
|
|
6.8 |
|
The Series D-2 Warrants were valued at the Closing Date and at June 30, 2010 using a binomial
option pricing model with the same assumptions used in the valuation of the Series D-1 Warrants.
6. 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 390,049 options outstanding under the
1994 Plan as of June 30, 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 June 30, 2010, there were a total of 3,143,304
options outstanding under the 2004 Plan and 2,977,477 shares remained available for future grant.
During the three months ended June 30, 2010, the Company granted options to purchase a total of
5,800,000 shares of common stock to two employees. These grants were
made outside of the Companys existing
stockholder-approved equity compensation plans but were otherwise
legally binding awards and did not require stockholder approval. These stock options are treated in all respects as
if granted under the Companys 2010 Equity Incentive Plan (the 2010 Plan). The 2010 Plan was
approved by the Companys stockholders at the Annual Meeting of Stockholders held on August 12,
2010. The 2010 Plan is similar to the 2004 Plan, other than with regard to the number of shares
authorized for issuance thereunder. The 2010 Plan provides for automatic increases to the number
of authorized shares available for grant under the 2010 Plan.
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 June 30, 2010, 849,999 shares of
common stock have been purchased under the
ESPP and 1 share of common stock is available for future issuance. At the Annual Meeting of
Stockholders held on August 12, 2010, the stockholders approved an amendment to the ESPP to extend
the term thereof from 2015 to 2025 and to increase the shares of common stock authorized for
issuance thereunder from 850,000 to 4,850,000.
15
Share-based compensation expense for the three-month periods ended June 30, 2010 and 2009 was
$81,000 and $1,491,000, respectively and $304,000 and $2,034,000 for the six months ended June 30,
2010 and 2009, respectively. As of June 30, 2010, there was $633,000 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 1.5 years.
The following table summarizes share-based compensation expense related to employee and director
stock options and ESPP purchases by expense category (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
|
|
|
$ |
566 |
|
|
$ |
|
|
|
$ |
632 |
|
General and administrative |
|
|
81 |
|
|
|
925 |
|
|
|
304 |
|
|
|
1,402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
expense included in
operating expenses |
|
$ |
81 |
|
|
$ |
1,491 |
|
|
$ |
304 |
|
|
$ |
2,034 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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.
The Company estimated the fair value of each option grant and ESPP purchase right on the date of
grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
Options: |
|
2010 |
|
|
2009 |
|
|
2010 |
|
|
2009 |
|
Risk-free interest rate |
|
|
2.6 |
% |
|
|
|
|
|
|
2.6 |
% |
|
|
0.6 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
|
|
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
106.5 |
% |
|
|
|
|
|
|
106.5 |
% |
|
|
295.0 |
% |
Expected life (years) |
|
|
5.8 |
|
|
|
|
|
|
|
5.8 |
|
|
|
5.6 |
|
|
|
|
|
|
|
|
|
|
|
|
Three and Six Months |
|
|
|
Ended |
|
|
|
June 30, |
|
ESPP: |
|
2010 |
|
|
2009 |
|
Risk-free interest rate |
|
|
0.2 |
% |
|
|
|
|
Dividend yield |
|
|
0.0 |
% |
|
|
|
|
Volatility |
|
|
90.5 |
% |
|
|
|
|
Expected life (months) |
|
|
3 |
|
|
|
|
|
The weighted-average fair value of options granted was $0.05 for the three and six months ended
June 30, 2010 and the weighted-average fair value of options granted for the six months ended
June 30, 2009 was $1.72. There were no options granted in the three months ended June 30, 2009.
For the ESPP, the weighted-average purchase price was $0.02 for both the three and six months ended
June 30, 2010. There were no purchases under the ESPP for the three and six months ended June 30,
2009.
16
A summary of the Companys stock option activity and related data for the six months ended June 30,
2010 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Exercise |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2009 |
|
|
3,508,568 |
|
|
$ |
6.99 |
|
Granted |
|
|
6,700,000 |
|
|
$ |
0.06 |
|
Forfeited / Expired |
|
|
(875,215 |
) |
|
$ |
4.41 |
|
|
|
|
|
|
|
|
|
Balance at June 30, 2010 |
|
|
9,333,353 |
|
|
$ |
2.25 |
|
|
|
|
|
|
|
|
|
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 with
Adamis, subject to the continued employment of the recipient through the closing date of the
Merger. As a result of the termination of the Merger with Adamis 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 and six months ended June 30, 2010.
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 June 30, 2010 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
7. Restructuring Costs
In connection with the termination of the clinical trials for Riquent in 2009, 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.
17
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 superseded 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 remained in full force and effect. The Retention Agreements did not
alter the amount of severance that was to be awarded under the Prior Employment Agreements, but
rather changed the events that triggered 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 was
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 $269,000 that were paid in December 2009 were fully earned as of March
31, 2010, of which $222,000 and $47,000 were charged to general and administrative expense for the
quarter ended March 31, 2010 and the year ended December 31, 2009, respectively. The fully-earned
Severance Payments, including related employer taxes, of $550,000, were paid during the quarter
ended June 30, 2010. Of the $550,000 that was paid as of June 30, 2010, $456,000 and $94,000 were
charged to general and administrative expense for the quarter ended March 31, 2010 and the year
ended December 31, 2009, respectively.
As an incentive to retain the Officers and an additional employee to pursue a strategic transaction
such as a financing, merger, license agreement, third party collaboration or wind down of the
Company, in April 2010, the Compensation Committee approved retention bonuses for a total of up to
approximately $600,000, depending on the type of strategic transaction completed (Strategic
Transaction Bonus). Upon the closing of the financing in May 2010, the officers and an additional
employee were paid a Strategic Transaction Bonus totaling $296,000.
8. Commitments and Contingencies
As of June 30, 2010, there were no material operating leases, notes payable, purchase commitments
or capital leases.
The Company extended certain of its liability insurance policies in June 2010 covering future
periods.
18
|
|
|
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 May 2010, we sold approximately 29.0 million shares of common stock and 5,134 shares of
redeemable convertible preferred stock, for aggregate gross proceeds of approximately $6.0 million in a
private placement. The investors also received a three-year warrant to purchase, for cash, an
additional 10,268 shares of convertible preferred stock for an aggregate exercise price of
approximately $10.3 million. The investors will be required to exercise the warrants and purchase
the additional shares of convertible preferred stock in the event that the Company consummates a
Strategic Transaction (as defined in the Certificate of Designations) approved by the investors.
The investors also received an additional three-year warrant to purchase, for cash or on a
cashless basis, an additional 5,134 shares of convertible preferred stock for an aggregate exercise
price of approximately $5.1 million, if exercised on a cash basis; the Company will receive no cash
proceeds and issue fewer shares if the warrants are exercised on a cashless basis. In addition, if
the investors purchase the additional 10,268 shares of preferred stock that must be purchased for
cash, they will receive an additional three-year warrant to purchase, for cash or on a cashless
basis, an additional 10,268 shares of preferred stock on the same terms as provided in the cashless
warrants issued at the initial close.
Each share of convertible preferred stock will be initially convertible into shares of our
common stock at a conversion rate of 66,667 shares of common stock per share of preferred stock
that is converted; this conversion rate may be increased under certain circumstances. Certain of
the convertible preferred stock will bear a dividend of 15% per annum, payable semi-annually in
additional shares of convertible preferred stock. Certain of the convertible preferred stock are
subject to redemption if we do not consummate a Strategic Transaction within nine months of the
initial closing. The Company is required to obtain the vote of the holders of the convertible
preferred stock prior to taking certain corporate actions and has also agreed to certain
limitations on its spending until a Strategic Transaction is consummated.
19
Based
upon funds received in the May 2010 financing and parameters established by those financing
documents, 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:
|
|
|
Develop, sell or out-license our Riquent program, although we may not receive any
significant value upon such a sale or license; and |
|
|
|
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. |
Following
the negative results of the Phase 3 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 dilutive to our existing stockholders and may deplete
our 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.
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 received in February 2009, 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. |
20
|
|
|
In December 2009, we entered into an Agreement and Plan of Reorganization (the
Merger Agreement) by and among the Company, Jewel Merger Sub, Inc. and Adamis
Pharmaceuticals Corporation (Adamis). The transaction contemplated by the Merger
Agreement was structured as a reverse merger, in which Jewel Merger Sub,
Inc., 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 on March 4, 2010. |
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.
In addition to those critical accounting policies previously disclosed in our Annual Report on
Form 10-K for the year ended December 31, 2009, the following are critical accounting policies that
have been added during the six months ended June 30, 2010:
Derivative Liabilities
In conjunction with the financing transaction that took place in May 2010, we issued
redeemable convertible preferred stock with certain embedded derivative features, as well as
warrants that are accounted for as derivative liabilities (see Note 5
to the condensed consolidated financial statements). These derivative
liabilities were determined to be ineligible for equity classification due to provisions of the
underlying preferred stock whereby redemption is outside of our sole control and due to provisions
that may result in an adjustment to their exercise or conversion price.
Our
derivative liabilities are recorded at estimated fair value on the date of issuance and are
adjusted to reflect estimated fair value at each period end, with any
increase or decrease in estimated fair value
being recorded as other income or expense. The fair value of these liabilities is estimated using
option pricing models that are based on the individual
characteristics of the common stock and preferred stock, the derivative liability
on the valuation date, as well as assumptions for expected volatility, expected life and risk-free
interest rate. If any of these assumptions are materially incorrect, the resulting accounting
treatment could change significantly.
Alternative models could have been
selected to calculate these fair values, which may have produced significantly
different results. If we adopt a different valuation model in the future, this
may result in a lack of consistency between periods and materially affect our
fair value estimates. It may also result in a lack of comparability with other
companies that use different models, methods and assumptions. Additionally,
because the estimated fair values are affected by our stock price, fluctuations
in our stock price, which can be volatile, may significantly affect our
financial results.
Recent Accounting Pronouncements
There were no Accounting Standards Updates adopted by us or issued during the six months ended
June 30, 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.
21
Results of Operations
There were no revenues for the three months ended June 30, 2010 and 2009 and the six months
ended June 30, 2010. For the six months ended June 30, 2009, revenue was $8.1 million. Revenue
for the six months ended June 30, 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 of $8.1 million.
For the three months ended June 30, 2010, we incurred virtually no research and development expense compared to a credit of $0.1 million for the same period in 2009.
For the six months ended June 30, 2010, research and development expense was similarly insignificant compared to $9.8 million for the same period in 2009,
as a result of the discontinuation of the Riquent Phase 3 ASPEN study which had been actively in process during part of that period.
For the three and six months ended June 30, 2010, general and administrative expense decreased
to $0.9 million and $2.7 million, respectively, from $2.1 million and $4.6 million for the same
periods in 2009. The decreases for the three and six months ended June 30, 2010 are primarily the
result of decreases of $0.8 million and $1.2 million, respectively, due to the termination of a
majority of our workforce in April 2009, with the remainder due to decreases in consulting and
legal services related to our restructuring activities in the first two quarters of 2009.
Non-operating
expense as a result of the estimated the fair value of derivative liabilities upon
issuance for the three and six months ended June 30, 2010 was $5.0 million. The charge was a result of the expense recorded for
the estimated fair value of warrants and instruments with certain embedded derivative features that
we issued in the May 2010 financing. These derivative liabilities are required to be recorded at
their estimated fair value upon issuance and remeasured at estimated fair value at each subsequent
reporting period.
Non-operating income as a result of adjustments to the estimated fair value of derivative
liabilities for the three and six months ended June 30, 2010 was $3.0 million. The derivative liabilities issued in the May 2010
financing were remeasured at their estimated fair value as of June 30, 2010 resulting in a decrease
in value from their issuance based upon changes in the inputs to the valuation models used to estimate the liabilities. This resulted in $3.0 million of non-operating income for
the three and six months ended June 30, 2010.
Financing transaction costs for the three and six months ended June 30,
2010 were $0.2 million. The costs directly related to completing the May 2010 financing, and were primarily comprised of
legal expenses.
Interest
income and other expense, net, was less than $0.1 million for the
three and six months ended June 30, 2010 and 2009. Our notes payable and capital leases were repaid
during the quarter ended June 30, 2009 and we moved all short-term investments to non-interest
bearing cash accounts during the quarter ended March 31, 2009.
Liquidity and Capital Resources
From inception through June 30, 2010, we have incurred a cumulative net loss of approximately
$429.2 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 June 30, 2010, we have raised approximately $417.0 million in net
proceeds from sales of equity securities.
At June 30, 2010, we had $8.1 million in cash, of which up to $5.2 million, plus accrued
dividends, could be required to be paid upon the triggering of a redemption right under our
outstanding preferred securities, as compared to $4.3 million of cash at December 31, 2009. Our
working capital at June 30, 2010 was a deficit of $0.4 million, as compared to $4.2 million at December 31,
2009 and is largely driven by our derivative liability obligations which will likely change in value and the change in value can be significant, either up or down, based on changes
in the inputs to the valuation models used to derive them. The increase in cash resulted from the net proceeds of $6.0 million received in the May 2010
financing offset by the use of our financial resources to fund our general corporate operations.
22
Our history of recurring losses from operations, our cumulative net loss as of June 30, 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 June 30, 2010.
Our current business operations are focused on using our financial resources to fund our
current obligations while we seek to either acquire new assets for development or pursue the
possible further development of Riquent, 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:
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our ability to sell, out-license or otherwise develop our Riquent program; and |
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our ability to consummate a strategic transaction such as a merger, license
agreement or other collaboration with a third party where we seek new compounds for
development and seek additional capital. |
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.
ITEM 4. 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 June
30, 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 June
30, 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.
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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 June 30, 2010 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
ITEM 1A. Risk Factors
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) and in our Quarterly Report
on Form 10-Q for the quarter ended March 31, 2010. The following factors, along with those in the
documents noted above, 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.
As of
June 30, 2010, we had a deficit of approximately $0.4 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. Even with the money
raised in the May 2010 financing, we have only
limited assets available to operate and develop our business. We are utilizing the funds received
in the May 2010 financing to evaluate whether or not Riquent may be developed further. 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 use the funds received from
the May 2010 financing to attempt
to develop the compound ourselves. If we determine that Riquent has no remaining value, then we
would need to acquire rights to another drug candidate for development.
Given the limited working capital that we have available, we will likely need to raise significant
amounts of additional capital if we elect to develop Riquent on our own or develop a drug candidate
acquired from another party. Raising this capital may not be possible or, if possible, may be on
terms that are highly unfavorable. If we are not able to develop Riquent or acquire rights to
another drug candidate for development, we may be forced to liquidate the Company. In that event,
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.
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 financing transaction in May 2010, we have been evaluating potential pharmaceutical
products for in-licensing or acquisition and have engaged consultants to determine whether there is
any potential for the further development of Riquent in light of recent renewed interest in
pharmaceutical products being developed by other companies for the treatment of Systemic Lupus
Erythematosus (SLE), among other uses. There is a substantial risk that we may not be successful in
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 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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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.
Our ability to raise additional capital and enter into strategic transactions requires the approval
of certain investors from the May 2010 financing.
The terms of the Certificate of Designations impose many restrictions on the Company and our
ability to engage in certain actions. For example, the Certificate of Designations provides that
the Company may not: issue capital stock; enter into a definitive agreement that, if consummated,
would effect a change of control; amend its certificate of incorporation; or take corporate action
that, if consummated, would represent a Strategic Transaction. Accordingly, even if we identify an
opportunity to further develop Riquent or another drug candidate, our ability to enter into an
appropriate arrangement to continue our operations may be more difficult than in the absence of
these restrictions. We may be prohibited from developing a partnership to further develop Riquent
or entering into an agreement to acquire rights to another drug candidate for development if we do
not receive approval from the requisite investors. If we cannot develop a product, our resources
will continue to be depleted and our ability to continue operations will be adversely affected.
Moreover, the Company faces negative consequences if it is not able to consummate a Strategic
Transaction on or before February 26, 2011. If the Company is not able to consummate a Strategic
Transaction, the holders of Series C Preferred may require the Company to redeem their shares for
an amount equal to the sum of $1,000 per share of Series C Preferred (subject to adjustment in
certain circumstances) and all accrued and unpaid dividends on such share of Series C Preferred.
Such payment would further deplete the Companys resources and, as such, may result in the Company
having to liquidate its business.
The May 2010 financing has already caused, and will continue to cause, our existing stockholders to
suffer substantial dilution.
Upon the closing of the May 2010 financing, the Company issued the investors approximately 29
million shares of common stock and approximately 5,000 shares of Series C-1 Preferred. The issuance
of such a large number of shares of common stock diluted the ownership of our existing stockholders
and provided the new investors with a sizeable interest in the Company. Moreover, the shares of
Preferred Stock issued to the investors are initially convertible into common stock at a rate of
66,667 shares of common stock for each share Preferred Stock held. Thus, when the investors convert
their shares of Preferred Stock, there will be a significant increase
in the number of shares of common stock outstanding. Existing stockholders will accordingly suffer further
dilution. At the closing of the financing, investors also received warrants to purchase shares of
Preferred Stock, which are also initially convertible into common stock at a rate of 66,667 shares
of common stock for every share of Preferred Stock held. Further dilution to existing stockholders
will occur upon conversion of the shares of Preferred Stock issuable upon exercise of the warrants.
Moreover, certain shares of Preferred Stock are entitled to dividends that are payable in
additional shares of Preferred Stock, which are again initially convertible into
shares of common stock at a rate of 66,667 shares of common stock for each share of Preferred Stock
held. The initial conversion rate of 66,667 shares of common stock for each share of Preferred
Stock may be adjusted upon certain events, resulting in an increase in the number of shares of
common stock that will be issued upon conversion of one share of Preferred Stock, which will serve
to further dilute the ownership of existing stockholders.
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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.
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.
Although the trading price of our common stock has not been as volatile in recent months, our stock
has generally experienced significant price and volume volatility since February 2009 due to, among
other things, the futility determination of the Riquent Phase 3 clinical trial in February 2009, our
efforts to dissolve the Company in October 2009 and the termination of our Merger Agreement with
Adamis in March 2010. Our stock is currently trading at approximately $0.04 per share and we could
continue to experience further declines in our stock price. The market price of our common stock
could continue to be 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 financings, mergers or other strategic transactions; |
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future sales of significant amounts of our capital 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.
26
Our financial reporting is complicated and may confuse investors.
The
securities we issued in the May 2010 financing have certain
features that result in mark to market accounting under
ASC Topic 815, Derivatives and Hedging . These accounting rules require that our
derivative instruments be adjusted to their fair market values at each reporting date, which means
that we will likely report significant non-cash gains or losses in future periods as our stock
price moves down or up, thereby changing the deemed value of the derivative instruments. These
gains and losses can be vary substantial each period and may result in significant
period-over-period swings in our GAAP operating results. For example, for the quarter ended June
30, 2010, we recorded a non-cash net loss on the fair value of our derivative instruments of
approximately $2.0 million. As a result, investors are cautioned to carefully read our financial
statements, the notes thereto and the Managements Discussion & Analysis of Financial Condition and
Results of Operations for a more complete understanding of our operating results. Prior results
may not be indicative of future results and periods reflecting significant non-cash income under
these accounting rules would not correspond to significant positive
cash flows that investors may
normally expect.
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ITEM 6. EXHIBITS
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Exhibit |
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Number |
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Description |
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3.1 |
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Certificate of Designations, Preferences and Rights of Series C-1
Convertible Preferred Stock, Series C-2 Convertible Preferred Stock,
Series D-1 Convertible Preferred Stock and Series D-2 Convertible
Preferred Stock (previously filed with the Companys Current Report on
Form 8-K filed May 28, 2010 and incorporated by reference herein) |
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10.1 |
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Securities Purchase Agreement, dated as of May 24, 2010 by and among
the Company and the Purchasers named therein (previously filed with
the Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.2 |
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Form of Series C-2 Preferred Stock Purchase Warrant (previously filed
with the Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.3 |
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Form of Series D-1 Preferred Stock Purchase Warrant (previously filed
with the Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.4 |
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Form of Series D-2 Preferred Stock Purchase Warrant (previously filed
with the Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.5 |
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Chief Executive Officer Employment Agreement, dated as of May 24,
2010, by and between the Company and Deirdre Y. Gillespie, M.D.
(previously filed with the Companys Current Report on Form 8-K filed
May 28, 2010 and incorporated by reference herein) |
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10.6 |
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Confidential Retention Agreement, dated as of May 24, 2010, by and
between the Company and Deirdre Y. Gillespie, M.D. (previously filed
with the Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.7 |
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Executive Employment Agreement, dated as of May 24, 2010, by and
between the Company and Gail A. Sloan (previously filed with the
Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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10.8 |
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Confidential Retention Agreement, dated as of May 24, 2010, by and
between the Company and Gail A. Sloan (previously filed with the
Companys Current Report on Form 8-K filed May 28, 2010 and
incorporated by reference herein) |
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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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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: August 20, 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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Chief Financial Officer and Secretary
(As Principal Financial and Accounting Officer) |
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