10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For the quarterly period ended March 31, 2009
OR
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE
ACT OF 1934 |
For the transition period from to
Commission file number: 0-24274
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
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Delaware
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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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6455 Nancy Ridge Drive
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92121 |
San Diego, CA
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(Zip Code) |
(Address of principal executive offices) |
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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
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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 þ
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Non-accelerated filer o
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Smaller reporting company o |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of shares of the registrants common stock, $0.01 par value per share, outstanding at
May 4, 2009 was 65,722,648.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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March 31, |
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December 31, |
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2009 |
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2008 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
17,563 |
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$ |
9,447 |
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Short-term investments |
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10,000 |
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Prepaids and other current assets |
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1,561 |
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785 |
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Total current assets |
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19,124 |
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20,232 |
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Property and equipment, net |
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302 |
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357 |
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Patent costs and other assets, net |
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252 |
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250 |
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Total assets |
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$ |
19,678 |
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$ |
20,839 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
9,771 |
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$ |
4,626 |
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Accrued clinical/regulatory expenses |
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909 |
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3,957 |
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Accrued expenses |
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331 |
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1,008 |
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Accrued payroll and related expenses |
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782 |
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1,549 |
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Accrued severance |
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1,048 |
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Credit facility |
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5,933 |
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Current portion of obligations under notes payable |
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155 |
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152 |
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Current portion of obligations under capital leases |
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11 |
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11 |
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Total current liabilities |
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13,007 |
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17,236 |
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Non-current portion of obligations under notes payable |
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149 |
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179 |
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Non-current portion of obligations under capital leases |
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32 |
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34 |
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Commitments |
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Stockholders equity: |
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Common stock |
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657 |
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555 |
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Additional paid-in capital |
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425,772 |
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418,522 |
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Accumulated deficit |
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(419,939 |
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(415,687 |
) |
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Total stockholders equity |
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6,490 |
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3,390 |
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Total liabilities and stockholders equity |
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$ |
19,678 |
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$ |
20,839 |
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Note: The condensed consolidated balance sheet at December 31, 2008 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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March 31, |
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2009 |
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2008 |
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Revenue from collaboration agreement |
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$ |
8,125 |
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$ |
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Expenses: |
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Research and development |
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9,893 |
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11,338 |
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General and administrative |
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2,487 |
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1,906 |
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Total expenses |
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12,380 |
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13,244 |
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Loss from operations |
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(4,255 |
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(13,244 |
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Interest income |
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12 |
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360 |
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Interest expense |
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(9 |
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(16 |
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Realized loss on investments, net |
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(737 |
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Net loss |
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$ |
(4,252 |
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$ |
(13,637 |
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Basic and diluted net loss per share |
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$ |
(0.08 |
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$ |
(0.34 |
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Shares used in computing basic and diluted net loss per share |
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56,115 |
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39,631 |
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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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Three Months Ended |
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March 31, |
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2009 |
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2008 |
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Operating activities: |
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Net loss |
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$ |
(4,252 |
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$ |
(13,637 |
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Adjustments to reconcile net loss to net cash used for operating activities: |
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Depreciation and amortization |
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74 |
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284 |
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Loss on write-off/disposal of patents and property and equipment |
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23 |
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Share-based compensation expense |
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542 |
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1,117 |
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Realized loss on investments, net |
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737 |
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Amortization of investment premium |
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243 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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(776 |
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48 |
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Accounts payable |
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5,145 |
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875 |
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Accrued clinical/regulatory expenses |
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(3,048 |
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(2,175 |
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Accrued expenses |
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(677 |
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85 |
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Accrued payroll and related expenses |
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(767 |
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(498 |
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Accrued severance |
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1,048 |
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Net cash used for operating activities |
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(2,711 |
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(12,898 |
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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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24,665 |
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Additions to property and equipment |
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(18 |
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(32 |
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Increase in patent costs and other assets |
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(3 |
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(99 |
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Net cash provided by investing activities |
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9,979 |
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24,534 |
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Financing activities: |
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Net proceeds from issuance of common stock |
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71 |
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Net proceeds from issuance of preferred stock |
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6,810 |
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Payments on credit facility |
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(5,933 |
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Payments on obligations under notes payable |
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(27 |
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(42 |
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Payments on obligations under capital leases |
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(2 |
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(3 |
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Net cash provided by financing activities |
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848 |
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26 |
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Net increase in cash and cash equivalents |
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8,116 |
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11,662 |
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Cash and cash equivalents at beginning of period |
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9,447 |
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4,373 |
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Cash and cash equivalents at end of period |
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$ |
17,563 |
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$ |
16,035 |
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
March 31, 2009
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company and its wholly-owned subsidiary (the Company) have been prepared in accordance with U.S.
generally accepted accounting principles (GAAP) for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all
of the information and disclosures required by GAAP for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring accruals and the
restructuring costs see Note 6 for further details) considered necessary for a fair presentation
have been included. Operating results for the three months ended March 31, 2009 are not
necessarily indicative of the results that may be expected for other quarters or the year ended
December 31, 2009. 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, 2008 included in the Companys
Form 10-K filed with the Securities and Exchange Commission.
In February 2009, the Company announced that an Independent Monitoring Board for the Riquent® Phase
3 ASPEN study had completed their 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 subsequently initiated steps to significantly reduce its operating costs, including the termination of 75 employees which was effected in April 2009
(see Note 6), and ceased all Riquent manufacturing and regulatory activities.
The Company has a history of recurring losses from operations, and as of March 31, 2009, the
Company had an accumulated deficit of $419,939,000, available cash and cash equivalents of
$17,563,000 and working capital of $6,117,000. These factors raise substantial doubt about the
Companys ability to continue as a going concern. The accompanying consolidated financial
statements have been prepared assuming that the Company will continue as a going concern. This
basis of accounting contemplates the recovery of the Companys assets and the satisfaction of
liabilities in the normal course of business and this does not include any adjustments to reflect
the possible future effects on the recoverability and classification of assets or the amounts and
classification of liabilities that might be necessary should the Company be unable to continue as a
going concern.
In light of the Companys decision to discontinue development of the Riquent clinical program, the
Company is seeking to maximize the value of its remaining assets. The Company is currently
evaluating its strategic alternatives, which include the following:
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Sell or out-license the Companys remaining assets, including the Companys SSAO
compounds, although significant value is not expected to be received for them; |
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Pursue other potential strategic transactions, which could include mergers, license
agreements or other collaborations, with third parties; or |
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Implement an orderly wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company. |
4
In considering its strategic alternatives, the Company does not expect to realize any value from
its Riquent program and has therefore closed its New Drug Application for Riquent with the Food and
Drug Administration and has withdrawn its orphan drug designation for Riquent in Europe.
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 subsidiary, La Jolla Limited, which was
incorporated in England in October 2004. There have been no significant transactions related to La
Jolla Limited since its inception.
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 Pronouncement
In December 2007, the Financial Accounting Standards Board (FASB) ratified the consensus reached by
the Emerging Issues Task Force (EITF) on EITF Issue No. 07-1, Accounting for Collaborative
Arrangements (EITF No. 07-1). EITF No. 07-1 requires collaborators to present the results of
activities for which they act as the principal on a gross basis and report any payments received
from (made to) other collaborators based on other applicable U.S. GAAP or, in the absence of other
applicable U.S. GAAP, based on analogy to authoritative accounting literature or a reasonable,
rational, and consistently applied accounting policy election. Further, EITF No. 07-1 clarified
that the determination of whether transactions within a collaborative arrangement are part of a
vendor-customer (or analogous) relationship subject to EITF No. Issue 01-9, Accounting for
Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendors Products). On
January 1, 2009, the Company adopted the provisions of EITF No. 07-1, which did not have a material
effect on the Companys unaudited condensed consolidated financial statements for the three months
ended March 31, 2009, given that the Companys only significant collaboration was entered into
during that period.
Revenue Recognition
On January 4, 2009, the Company 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). The Development Agreement was terminated on March
27, 2009 following the failure of the ASPEN trial. See Note 4 for further details related to the
Development Agreement.
The Development Agreement contained multiple potential revenue elements, including non-refundable
upfront fees. The Company applies the revenue recognition criteria outlined in Staff Accounting
Bulletin (SAB), No. 104, Revenue Recognition, Emerging Issues Task Force Issue 00-21, Revenue
Arrangements with Multiple Deliverables (EITF 00-21), and EITF No. 07-1. In applying these
revenue recognition criteria, the Company considers a variety of factors in determining the
appropriate method of revenue recognition under these arrangements, such as whether the elements
are separable, whether there are determinable fair values and whether there is a unique earnings
process associated with each element of a contract.
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 in accordance with SFAS No. 128, Earnings per Share, and Staff
Accounting Bulletin No. 98. Basic earnings per share (EPS) is calculated by dividing the net
income or loss by the weighted-average number of common shares outstanding for the period, without
consideration for common share equivalents. Diluted EPS is computed by dividing the net income or
loss by the weighted-average number of common share equivalents outstanding for the period
determined using the treasury-stock method. For purposes of this calculation, stock options,
common stock subject to repurchase by the Company, common stock issuable upon the conversion of
Preferred stock and warrants are considered to be common stock equivalents and are only included in
the calculation of diluted EPS when their effect is dilutive.
5
Because the Company has incurred a net loss for both periods presented in the unaudited condensed
consolidated statements of operations, stock options, common stock subject to repurchase, common
stock issuable upon the conversion of Preferred stock and warrants are not included in the
computation of net loss per share because their effect is anti-dilutive. The shares used to
compute basic and diluted net loss per share represent the weighted-average common shares
outstanding, reduced by the weighted-average unvested common shares subject to repurchase, if any.
There were no unvested common shares subject to repurchase for the three-month periods ended March
31, 2009 and 2008.
Comprehensive Loss
In accordance with SFAS No. 130, Reporting Comprehensive Income (Loss), unrealized gains and losses
on available-for-sale securities are included in other comprehensive income (loss). There were no
unrealized gains or losses on available-for-sale securities for the three-month period ended March
31, 2009. The Companys comprehensive net loss was $13,651,000 for the three months ended March
31, 2008.
Impairment of Long-Lived Assets and Assets to Be Disposed Of
In accordance with SFAS No. 144, Accounting for the Impairment or Disposal 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 Phase 3 ASPEN trial, the Company discontinued the
Riquent Phase 3 ASPEN study and the development of Riquent. Based on these events, the future cash
flows from the Companys Riquent-related patents are no longer expected to exceed their carrying
values and the assets became impaired as of December 31, 2008. This rendered substantially all of
the Companys laboratory equipment, as well as a large portion of its furniture and fixtures and
computer equipment and software impaired as of December 31, 2008.
The Company recorded a non-cash charge for the impairment of long-lived assets of $2,810,000 for
the year ended December 31, 2008 to write down the value of the Companys long-lived assets to
their estimated fair values. No additional impairment was required as of March 31, 2009 for the
remaining $554,000 of impacted assets, as no additional impairment indicators exist.
3. Fair Value of Financial Instruments
Effective January 1, 2008, the Company adopted SFAS No. 157, Fair Value Measurements. SFAS 157
defines fair value, establishes a framework for measuring fair value under generally accepted
accounting principles and enhances disclosures about fair value measurements. Fair value is defined
under SFAS 157 as the exchange price that would be received for an asset or paid to transfer a
liability (an exit price) in the principal or most advantageous market for the asset or liability
in an orderly transaction between market participants on the measurement date. Valuation techniques
used to measure fair value under SFAS 157 must maximize the use of observable inputs and minimize
the use of unobservable inputs. The standard describes a fair value hierarchy based on three levels
of inputs, of which the first two are considered observable and the last unobservable, that may be
used to measure fair value which are the following:
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Level 1 Quoted prices in active markets for identical assets or liabilities. |
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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. |
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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. |
6
As of March 31, 2009, cash and cash equivalents were comprised of cash in checking accounts. The
Company held no investments as of March 31, 2009.
As of December 31, 2008, cash and cash equivalents were comprised of short-term, highly liquid
investments with maturities of 90 days or less from the date of purchase. Investments were
comprised of available-for-sale securities recorded at estimated fair value determined using level
3 inputs. Unrealized gains and losses associated with the Companys investments, if any, were
reported in stockholders equity in accordance with SFAS No. 115, Accounting for Certain
Investments in Debt and Equity Securities.
At December 31, 2008, short-term investments were comprised of $10,000,000 invested in auction rate
securities, which were sold to UBS at par value in January 2009 pursuant to an Auction Rate
Securities Agreement executed in November 2008.
4. Development and Stock Purchase Agreements
On January 4, 2009, the Company entered into the Development Agreement with BioMarin CF, a
wholly-owned subsidiary of BioMarin Pharma, granting BioMarin CF co-exclusive rights to develop and
commercialize Riquent (and certain potential follow-on products) (collectively, Riquent) in the
Territory, and the non-exclusive right to manufacture Riquent anywhere in the world. The
Territory includes all countries of the world except the Asia-Pacific Territory (i.e., all
countries of East Asia, Southeast Asia, South Asia, Australia, New Zealand, and other countries of
Oceania).
Under the terms of the Development Agreement, BioMarin CF paid the Company a non-refundable
commencement payment of $7,500,000 and purchased, through BioMarin Pharma, $7,500,000 of a newly
designated series of preferred stock (the Series B-1 Preferred Stock), pursuant to a related
securities purchase agreement described more fully below.
Following the futile results of the first interim efficacy analysis of Riquent received in February
2009, BioMarin CF elected not to exercise its full license rights to the Riquent program under the
Development Agreement. Thus, the Development Agreement between the parties terminated on March 27,
2009 in accordance with its terms. All rights to Riquent have been returned to the Company.
Accordingly, the $7,500,000 non-refundable commencement payment received in connection with this
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 to BioMarin Pharma at a
price per share of $22.1171 and received $7,500,000. 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 total sales
price included a premium over the fair value of the stock issued of $625,000, which was recorded as
revenue in the quarter ended March 31, 2009.
5. Stockholders Equity
Share-Based Compensation
In June 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(the 1994 Plan), under which, as amended, 1,640,000 shares of common stock were authorized for
issuance. The 1994 Plan expired in June 2004 and there were 657,865 options outstanding under the
1994 Plan as of March 31, 2009.
7
In May 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the 2004 Plan), under which, as amended, 6,400,000 shares of common stock have been authorized
for issuance. The 2004 Plan provides for the grant of incentive and non-qualified stock options, as
well as other share-based payment awards, to employees, directors, consultants and advisors of the
Company with up to a 10-year contractual life and various vesting periods as determined by the
Companys Compensation Committee or the Board of Directors, as well as automatic fixed grants to
non-employee directors of the Company. As of March 31, 2009, there were a total of 5,244,214
options outstanding under the 2004 Plan and 876,567 shares remained available for future grant.
In August 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (the ESPP), under which, as amended, 850,000 shares of common stock are reserved
for sale to eligible employees, as defined in the ESPP. Employees may purchase common stock under
the ESPP every three months (up to but not exceeding 10% of each employees base salary or hourly
compensation, and any cash bonus paid, subject to certain limitations) over the offering period at
85% of the fair market value of the common stock at specified dates. The offering period may not
exceed 24 months. As of March 31, 2009, 833,023 shares of common stock have been issued under the
ESPP and 16,977 shares of common stock are available for future issuance.
Expenses allocable to options or stock awards issued to non-employees, other than non-employee
directors, have been determined in accordance with Emerging Issues Task Force 96-18, Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. Options granted to such non-employees are periodically remeasured as
the options vest.
Share-based compensation expense recognized under SFAS 123R for the three-month periods ended March
31, 2009 and 2008 was $542,000 and $1,117,000, respectively. As of March 31, 2009, there was
$4,914,000 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 1.4 years.
The following table summarizes share-based compensation expense related to employee and director
stock options, restricted stock and ESPP purchases under SFAS 123R by expense category (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Research and development |
|
$ |
66 |
|
|
$ |
465 |
|
General and administrative |
|
|
476 |
|
|
|
652 |
|
|
|
|
|
|
|
|
Share-based compensation expense included in operating expenses |
|
$ |
542 |
|
|
$ |
1,117 |
|
|
|
|
|
|
|
|
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 the employee and director stock
options granted by the Company is determined in accordance with SFAS 123R using an option-pricing
model, that value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
8
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:
|
|
|
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2009 |
|
|
2008 |
|
Options: |
|
|
|
|
|
|
|
|
|
Risk-free interest rate |
|
|
0.6 |
% |
|
|
3.0 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
295.0 |
% |
|
|
108.9 |
% |
Expected life (years) |
|
|
1.0 |
|
|
|
5.6 |
|
|
|
|
|
|
|
|
March 31, |
|
|
|
2008 |
|
ESPP: |
|
|
|
|
|
Risk-free interest rate |
|
|
2.1 |
% |
Dividend yield |
|
|
0.0 |
% |
Volatility |
|
|
90.9 |
% |
Expected life (months) |
|
|
3 |
|
There were no purchases under the ESPP for the three months ended March 31, 2009.
The weighted-average fair values of options granted were $1.72 and $1.98 for the three months ended
March 31, 2009 and 2008, respectively. For the ESPP, the weighted-average purchase price was $1.67
for the three months ended March 31, 2008.
A summary of the Companys stock option activity and related data for the three months ended March
31, 2009 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
Number of |
|
|
Exercise |
|
|
|
Shares |
|
|
Price |
|
Balance at December 31, 2008 |
|
|
5,626,960 |
|
|
$ |
6.80 |
|
Granted |
|
|
691,875 |
|
|
$ |
1.73 |
|
Exercised |
|
|
|
|
|
$ |
|
|
Forfeited or expired |
|
|
(416,756 |
) |
|
$ |
9.47 |
|
|
|
|
|
|
|
|
|
Balance at March 31, 2009 |
|
|
5,902,079 |
|
|
$ |
6.01 |
|
|
|
|
|
|
|
|
|
6. Restructuring Costs
In connection with the termination of the clinical trials for Riquent, the Company ceased all
manufacturing and regulatory activities related to Riquent and initiated steps to significantly
reduce its operating costs, including the termination of 75
employees who received notification in February 2009 and were terminated in April 2009. Pursuant
to SFAS No. 112, Employers Accounting for Postemployment Benefits and SFAS No. 146, Accounting for
Costs Associated with Exit or Disposal Activities, 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. This
amount is expected to be paid out by the end of the second quarter of 2009.
7.
Commitments and Contingencies
The Company leases two adjacent buildings in San Diego, California covering a total of
approximately 54,000 square feet. Both building leases expire in July 2009. Pursuant to one of the
leases, the Company is responsible for completing modifications to the leased building prior to
lease expiration. Management has accrued a reasonable estimate for the cost of these modifications
as of March 31, 2009, however, an additional accrual may be
required as further information becomes available related to these
building modification costs.
The
Company renewed certain of its liability insurance policies in March
2009 covering future periods.
9
|
|
|
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. The analysis of the data from our Phase 3 ASPEN trial of Riquent
showed that the trial did not reach statistical significance with respect to its primary endpoint,
delaying time to renal flare or for either secondary endpoint, improvement in proteinuria or time
to major SLE flare and we decided to stop the study. Additional risk factors include the
uncertainty and timing of initiating a strategic transaction to maximize the value of our remaining
assets and continuing as a going concern. 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, 2008,
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 1.A. 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.
On January 4, 2009, we entered into a development and commercialization agreement (the
Development Agreement) with BioMarin CF Limited (BioMarin CF), a wholly-owned subsidiary of
BioMarin Pharmaceutical Inc. (BioMarin Pharma). Under the terms of the Development Agreement,
BioMarin CF was granted co-exclusive rights to develop and commercialize Riquent in the United
States, Europe and all other territories of the world, excluding the Asia Pacific region, and the
non-exclusive right to manufacture Riquent anywhere in the world. In connection with the
Development Agreement, we also entered into a securities purchase agreement with BioMarin Pharma.
In January 2009, BioMarin CF paid us a non-refundable commencement payment of $7.5 million pursuant
to the Development Agreement and BioMarin Pharma paid us $7.5 million in exchange for a newly
designated series of our preferred stock pursuant to the securities purchase agreement. As
described below, the Development Agreement was terminated on March 27, 2009.
In February 2009, we were informed by an Independent Monitoring Board for the Riquent Phase 3
ASPEN study that the monitoring board completed its review of the first interim efficacy analysis
of Riquent and determined that continuing the study was futile. We subsequently unblinded the data
and found that there was no statistical difference in the primary endpoint, delaying time to renal
flare, between the Riquent-treated group and the placebo-treated group, although there was a
significant difference in the reduction of antibodies to double-stranded DNA. There were 56 renal
flares in 587 patients treated with either 300-mg or 900-mg of Riquent, and 28 renal flares in 283
patients treated with placebo.
Based on these results, we immediately discontinued the Riquent Phase 3 ASPEN study and the
further development of Riquent. We had previously devoted substantially all of our research,
development and clinical efforts and financial resources toward the development of Riquent. In
connection with the termination of our clinical trials for Riquent, we subsequently initiated steps
to significantly reduce our operating costs, including the
termination of 75 employees, which was effected in April 2009. We also ceased the manufacture of
Riquent at our facility in San Diego, California, as well as all regulatory activities associated
with Riquent. Pursuant to SFAS No. 112, Employers Accounting for Postemployment Benefits and
SFAS No. 146, Accounting for Costs Associated with Exit or Disposal Activities, we recorded a
charge of approximately $1.1 million in the quarter ended March 31, 2009, of which $0.7 million was
included in research and development and $0.4 million was included in general and administrative
expense. This amount is expected to be paid out by the end of the second quarter of
2009.
10
Following the futile results of the first interim efficacy analysis of Riquent, BioMarin CF
has elected to not exercise its full license rights to the Riquent program under the Development
Agreement. Thus, the Development Agreement between the parties terminated on March 27, 2009 in
accordance with its terms. Pursuant to the securities purchase agreement between us and BioMarin
Pharma, the Companys Series B-1 preferred shares purchased by BioMarin Pharma were converted into
10,173,120 shares of common stock. Additionally, all rights to Riquent have been returned to us.
In light of our decision to discontinue development of our Riquent clinical program, we are
seeking to maximize the value of our remaining assets. We are currently evaluating our strategic
alternatives, which include the following:
|
|
|
Sell or out-license our remaining assets, including our SSAO compounds, although we
do not expect to receive any significant value for them; |
|
|
|
Pursue other potential strategic transactions, which could include mergers, license
agreements or other collaborations, with third parties; or |
|
|
|
Implement an orderly wind down of the Company if other alternatives are not deemed
viable and in the best interests of the Company. |
In considering our strategic alternatives, we do not expect to realize any value from our
Riquent program and we have therefore closed our New Drug Application (NDA) for Riquent with the
Food and Drug Administration (FDA) and have withdrawn our orphan drug designation for Riquent in
Europe.
Following the negative results of the ASPEN trial, we recorded a significant charge for the
impairment of our Riquent assets in 2008, including our Riquent-related patents, and it is unlikely
that we will realize any substantive value from these assets in the future. Additionally, there is
a substantial risk that we may not successfully implement any of these strategic alternatives, and
even if we determine to pursue one or more of these alternatives, we may be unable to do so on
acceptable terms. Any such transactions may be highly dilutive to our existing stockholders and may
deplete our limited remaining capital resources.
In January 2009, we sold all of our auction rate securities to our broker-dealer, UBS A.G.
(UBS) at par value of $10.0 million. As of December 31, 2008, we had previously recognized a
total impairment charge of $2.3 million as a result of the illiquidity of these securities, which
was fully offset by a realized gain of $2.3 million from UBSs repurchase agreement that provides
for a put option on these securities. Following the sale of these investments, we no longer hold
any auction-rate securities.
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 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, including those related to patent
costs, clinical/regulatory expenses and the fair value of our financial instruments. We base our
estimates on historical experience and on other assumptions that we believe to be reasonable under
the circumstances, the results of which form the basis for making judgments about the carrying
values of assets and liabilities that are not readily apparent from other sources. Actual results
may differ materially from these estimates under different assumptions or conditions.
We believe the following critical accounting policies involve significant judgments and
estimates used in the preparation of our condensed consolidated financial statements (see also Note
1 to our unaudited condensed consolidated financial statements included in Part I).
11
Revenue
recognition
The Development Agreement contained multiple potential revenue elements, including
non-refundable upfront fees. We apply the revenue recognition criteria outlined in Staff
Accounting Bulletin (SAB), No. 104, Revenue Recognition, Emerging Issues Task Force (EITF)
Issue 00-21, Revenue Arrangements with Multiple Deliverables (EITF 00-21), and EITF Issue
No. 07-1, Accounting for Collaborative Arrangements (EITF No. 07-1). In applying these revenue
recognition criteria, we consider a variety of factors in determining the appropriate method of
revenue recognition under these arrangements, such as whether the elements are separable, whether
there are determinable fair values and whether there is a unique earnings process associated with
each element of a contract.
Impairment and useful lives of long-lived assets
We regularly review our long-lived assets for impairment. Our long-lived assets include costs
incurred to file our patent applications. We evaluate the recoverability of long-lived assets by
measuring the carrying amount of the assets against the estimated undiscounted future cash flows
associated with them. At the time such evaluations indicate that the future undiscounted cash flows
of certain long-lived assets are not sufficient to recover the carrying value of such assets, the
assets are adjusted to their fair values. The estimation of the undiscounted future cash flows
associated with long-lived assets requires judgment and assumptions that could differ materially
from the actual results.
Costs
related to issued patents are amortized using the straight-line method
over the lesser of the remaining useful life of the related technology or the remaining patent
life, commencing on the date the patent is issued. Legal costs and expenses incurred in connection
with pending patent applications have been capitalized. We expense all costs related to abandoned
patent applications. If we elect to abandon any of our currently issued or unissued patents, the
related expense could be material to our results of operations for the period of abandonment. The
estimation of useful lives for long-lived assets requires judgment and assumptions that could
differ materially from the actual results. In addition, our results of operations could be
materially impacted if we begin amortizing the costs related to unissued patents.
For the year ended December 31, 2008, as a result of the futility determination in the ASPEN
trial, we recorded a non-cash charge for the impairment of long-lived assets of $2.8 million to
write down the value of our long-lived assets to their estimated fair values. No additional
impairment losses have been recorded on our long-lived assets for the three months ended March 31,
2009.
Accrued clinical/regulatory expenses
We review and accrue clinical trial and regulatory-related expenses based on work performed,
which relies on estimates of total costs incurred based on patient enrollment, sites activated and
other events. We follow this method because reasonably dependable estimates of the costs applicable
to various stages of a clinical trial can be made. Accrued clinical/regulatory costs are subject to
revisions as trials progress to completion. Revisions are charged to expense in the period in which
the facts that give rise to the revision become known. Historically, revisions have not resulted in
material changes to research and development costs.
Share-based compensation
We adopted Statement of Financial Accounting Standard (SFAS) No. 123R, Share-Based Payment
(SFAS 123R) using the modified prospective transition method, which requires the application of
the accounting standard as of January 1, 2006. Share-based compensation expense recognized under
SFAS 123R was approximately $0.5 million and $1.1 million for the three-month periods ended March
31, 2009 and 2008, respectively. As of March 31, 2009, there was approximately $4.9 million 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. We currently expect to recognize the remaining unrecognized
compensation cost over a weighted-average period of 1.4 years. Additional share-based compensation
expense for any new share-based payment awards granted after March 31, 2009 under all equity
compensation plans cannot be predicted at this time because it will depend on, among other matters,
the amounts of share-based payment awards granted in the future.
12
Option-pricing models were developed for use in estimating the value of traded options that
have no vesting or hedging restrictions and are fully transferable. Because the employee and
director stock options granted by us have characteristics that are significantly different from
traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in our opinion the existing valuation models may not provide an accurate measure
of the fair value of the employee and director stock options granted by us. Although the fair value
of the employee and director stock options granted by us is determined in accordance with SFAS 123R
using an option-pricing model, that value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
Recent Accounting Pronouncements
In December 2007, the Financial Accounting Standards Board (FASB) ratified the consensus
reached by the EITF on EITF No. 07-1. EITF No. 07-1 requires collaborators to present the results
of activities for which they act as the principal on a gross basis and report any payments received
from (made to) other collaborators based on other applicable U.S. GAAP or, in the absence of other
applicable U.S. GAAP, based on analogy to authoritative accounting literature or a reasonable,
rational, and consistently applied accounting policy election. Further, EITF No. 07-1 clarified
that the determination of whether transactions within a collaborative arrangement are part of a
vendor-customer (or analogous) relationship subject to EITF No. Issue 01-9, Accounting for
Consideration Given by a Vendor to a Customer (Including a Reseller of the Vendors Products). On
January 1, 2009, we adopted the provisions of EITF No. 07-1 which did not have a material effect on
our unaudited condensed consolidated financial statements for the three months ended March 31,
2009.
Results of Operations
For the three months ended March 31, 2009, revenue increased to $8.1 million as a result of
the Development Agreement entered into with BioMarin CF in January 2009. The Development Agreement
was terminated in March 2009 following the negative results from our Riquent Phase 3 ASPEN study.
For the three months ended March 31, 2009, research and development expense decreased to $9.9
million from $11.3 million for the same period in 2008 as a result of the discontinuation of the
Riquent Phase 3 ASPEN study. This decrease was partially offset by an increase in termination
expense, mainly relating to severance, of approximately
$0.7 million related to the termination of research and
development personnel. During April 2009, 65 research and development
personnel were terminated.
For the three months ended March 31, 2009, general and administrative expense increased to
$2.5 million from $1.9 million for the same period in 2008. This increase is primarily the result
of an increase in termination expense, mainly relating to severance, of approximately $0.4 million
related to the termination of general and administrative personnel as well as an increase in
consulting and professional services. During April 2009, 10 general
and administrative personnel were terminated.
Interest income, net, decreased to $0.03 million for the three months ended March 31, 2009,
from $0.3 million for the same period in 2008. The decrease was primarily due to lower average
balances of cash, cash equivalents and short-term investments and lower average interest rates as
compared to 2008.
Realized loss on investments, net, of $0.7 million for the three months ended March 31, 2008
primarily consisted of the other-than-temporary impairment loss on our auction rate securities
recorded in the first quarter of 2008, in connection with the adoption of SFAS 157. These
securities were sold to UBS at par value in January 2009.
Liquidity and Capital Resources
From inception through March 31, 2009, we have incurred a cumulative net loss of approximately
$419.9 million and have financed our operations through public and private offerings of securities,
revenues from collaborative agreements, equipment financings and interest income on invested cash
balances. From inception through March 31, 2009, we have raised approximately $410.8 million in
net proceeds from sales of equity securities.
13
At March 31, 2009, we had $17.6 million in cash and cash equivalents as compared to $19.4
million of cash, cash equivalents and short-term investments at December 31, 2008. Our working
capital at March 31, 2009 was $6.1 million, as compared to $3.0 million at December 31, 2008. The
decrease in cash, cash equivalents and short-term investments resulted from the use of our
financial resources to fund our clinical trial and manufacturing activities and for other general
corporate purposes. This decrease was partially offset by the non-refundable commencement payment
of $7.5 million received from BioMarin CF under the Development Agreement and the proceeds of $7.5
million from the sale of 339,104 shares of our preferred stock to BioMarin Pharma under the
securities purchase agreement in January 2009.
As of March 31, 2009, approximately $3.8 million of equipment ($0.2 million net of
depreciation and 2008 impairment charges) secured our notes payable and capital lease obligations.
We lease certain equipment under operating leases.
We also lease two adjacent buildings in San Diego, California covering a total of
approximately 54,000 square feet. Both building leases expire on
July 31, 2009. Pursuant to one of the leases, we are responsible
for completing modifications to the leased building prior to lease
expiration. Management has accrued a reasonable estimate for the cost
of these modifications as of March 31, 2009, however, should the
landlord take a more aggressive position on the interpretation of the
lease expiration obligations and prevail, the additional costs
could be significant.
The following table summarizes our contractual obligations at March 31, 2009 (in thousands).
Long-term debt obligations include interest.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment due by period |
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
|
More than |
|
|
|
Total |
|
|
1 Year |
|
|
1-3 Years |
|
|
3-5 Years |
|
|
5 Years |
|
Long-Term Debt Obligations |
|
$ |
341 |
|
|
$ |
180 |
|
|
$ |
161 |
|
|
$ |
|
|
|
$ |
|
|
Capital Lease Obligations |
|
|
51 |
|
|
|
15 |
|
|
|
36 |
|
|
|
|
|
|
|
|
|
Operating Lease Obligations |
|
|
429 |
|
|
|
278 |
|
|
|
140 |
|
|
|
11 |
|
|
|
|
|
Purchase Obligations |
|
|
50 |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
871 |
|
|
$ |
523 |
|
|
$ |
337 |
|
|
$ |
11 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We intend to use our financial resources to fund our current obligations and to pursue other
strategic alternatives that may become available to us. In the future, it is possible that we will
not have adequate resources to support continued operations and we will need to cease operations.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
|
|
|
our ability to sell, out-license or otherwise dispose of our assets, including our
SSAO compounds, although we do not expect to receive any significant value for them; |
|
|
|
our ability to consummate a merger with another company; or |
|
|
|
our ability to negotiate favorable settlement terms with our creditors, as well as
any actions that may be taken by our creditors, which could force us to wind down the
Company. |
There can be no assurance that we will be able to enter into any strategic transactions on
acceptable terms, if any, and our negotiating position may worsen as we continue to utilize our
existing resources.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current
or future effect on our consolidated financial condition, changes in our consolidated financial
condition, expenses, consolidated results of operations, liquidity, capital expenditures or capital
resources.
14
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We do not utilize derivative financial instruments, derivative commodity instruments or other
market risk sensitive instruments, positions or transactions in any material fashion. We currently
do not invest in any securities that are materially and directly affected by foreign currency
exchange rates or commodity prices.
At March 31, 2009, all of our cash and cash equivalents consisted of cash. At December 31,
2008, all of our investment securities, which consisted of money market funds, U.S. Treasury bills
and asset-backed student loan auction rate securities, were classified as available-for-sale and
were therefore reported on the balance sheet at market value.
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
March 31, 2009. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and
15d-15(e) under the Securities Exchange Act of 1934, as amended (Exchange Act), means controls
and other procedures of a company that are designed to ensure that information required to be
disclosed by a company in the reports that it files or submits under the Exchange Act is recorded,
processed, summarized and reported, within the time periods specified in the Securities and
Exchange Commissions rules and forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that information required to be disclosed by
a company in the reports that it files or submits under the Exchange Act is accumulated and
communicated to the companys management, including its principal executive and principal financial
officers, as appropriate to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide
only reasonable assurance of achieving their objectives and management necessarily applies its
judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on
the evaluation of our disclosure controls and procedures as of March 31, 2009, our principal
executive officer and principal financial officer concluded that, as of such date, the Companys
disclosure controls and procedures were effective at the reasonable assurance level.
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) occurred during the quarter ended March 31, 2009 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
15
PART II. OTHER INFORMATION
ITEM 1.A. Risk Factors
I. RISK FACTORS RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND THE INDUSTRY IN WHICH WE OPERATE.
We are updating and restating the risk factors included in our Annual Report on Form 10-K for
our fiscal year ended December 31, 2008 as follows:
In light of our decision to discontinue development of our Riquent clinical program, we are seeking
to maximize the value of our remaining assets, address our liabilities and attempt to pursue
mergers or similar strategic transactions. We may be unable to satisfy our liabilities and can
provide no assurances that we can be successful in pursuing a strategic transaction.
In February 2009, we were informed by an Independent Monitoring Board for the Riquent
Phase 3 ASPEN study that the monitoring board completed its review of the first interim efficacy
analysis and determined that continuing the study was futile. Based on these results, we
immediately discontinued the Riquent Phase 3 ASPEN study and the development of Riquent. We had
previously devoted substantially all of our research, development and clinical efforts and
financial resources toward the development of Riquent and, in light of the failure of the trial, we
subsequently incurred a significant impairment charge as we wrote down the value of our Riquent
assets to near zero. In connection with the termination of our clinical trials for Riquent, we
initiated steps to significantly reduce our operating costs including the termination of 75 employees, which was effected in April 2009. We also ceased the
manufacture of Riquent at our facility in San Diego, California, as well as all regulatory
activities associated with Riquent and have begun exploring strategic alternatives to maximize
stockholder value, including the possible sale or licensing out of our remaining assets, a
potential merger with another company or the winding down of operations. In considering our
strategic alternatives, we do not expect to realize any value from the Riquent program and have
therefore closed our NDA for Riquent with the FDA and have withdrawn our orphan drug designation
for Riquent in Europe.
There is a substantial risk that we may not successfully implement any of these strategic
alternatives, and even if we determine to pursue one or more of these alternatives, we may be
unable to do so on acceptable 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. We
may be unable to discharge our liabilities or negotiate favorable settlement terms with our
creditors.
Stockholders should recognize that in our efforts to address our liabilities and fund the
future development of our Company, we may pursue strategic alternatives that result in the
stockholders of the Company having little or no continuing interest in the assets or equity of the
Company. We will continue to evaluate our alternatives in light of our cash position, including the
possibility that we may need to seek protection under the provisions of the U.S. Bankruptcy Code.
We may need to liquidate the Company in a voluntary dissolution under Delaware law or seek
protection under the provisions of the U.S. Bankruptcy Code, and, in either event, it is unlikely
that stockholders would receive any value for their shares.
We have not generated any revenues from product sales, and have incurred losses in each
year since our inception in 1989. We expect that it will be very difficult to raise capital to
continue our operations and our independent registered public accounting firm has issued an opinion
with an explanatory paragraph to the effect that there is substantial doubt about our ability to
continue as a going concern. We do not believe that we could succeed in raising additional capital
needed to sustain our operations without some strategic transaction, such as a merger. If we are
unable to consummate such a transaction, we expect that we would need to cease all operations and
wind down. Although we are currently evaluating our strategic alternatives with respect to all
aspects of our business, we
16
cannot assure you that any actions
that we take would raise or generate sufficient capital to fully address the uncertainties of our
financial position. As a result, we may be unable to realize value from our assets and discharge
our liabilities in the normal course of business. If we are unable to settle our obligations to our
creditors or if we are unable to consummate a strategic transaction, we would likely need to
liquidate the Company in a voluntary dissolution under Delaware law or seek protection under the
provisions of the U.S. Bankruptcy Code. In that event, we, or a trustee appointed by the court, may
be required to liquidate our assets. In either of these events, we might realize significantly less
from our assets than the values at which they are carried on our financial statements. The funds
resulting from the liquidation of our assets would be used first to satisfy obligations to
creditors before any funds would be available to pay our stockholders, and any shortfall in the
proceeds would directly reduce the amounts available for distribution, if any, to our creditors and
to our stockholders. In the event we are required to liquidate under Delaware law or the federal
bankruptcy laws, it is highly unlikely that stockholders would receive any value for their shares.
We recorded an impairment loss for the year ended December 31, 2008 and may need to record
additional charges in the future.
In light of our decisions to discontinue the development of Riquent, reduce our
workforce, evaluate the possible sale of our equipment and other personal property assets, and
consider our strategic alternatives with respect to all aspects of our business, management
concluded that, under Statement of Financial Accounting Standards (SFAS) No. 144, Accounting for
the Impairment or Disposal of Long-Lived Assets, as of December 31, 2008, the carrying amount of
the asset group was not fully recoverable and that a material impairment did exist. Accordingly, we
recorded a non-cash charge of $2.8 million for impairment of assets during the fourth quarter of
2008. As we continue to evaluate our business and our assets under SFAS 144, we may need to
reflect additional impairment charges in the future, which would negatively impact our financial
results and our overall value of the Company.
We face environmental liabilities related to certain hazardous materials used in our operations.
Due to the nature of our manufacturing processes, we are subject to stringent federal,
state and local laws governing the use, handling and disposal of certain materials and wastes.
Historically, in our research and manufacturing activities we have used radioactive and other
materials that could be hazardous to human health, safety or the environment. These materials and
various wastes resulting from their use are stored at our facility pending ultimate use and
disposal. The risk of accidental injury or contamination from these materials cannot be eliminated.
In the event of such an accident, we could be held liable for any resulting damages, and any such
liability could exceed our resources. Although we maintain general liability insurance, we do not
specifically insure against environmental liabilities.
II. RISK FACTORS RELATED SPECIFICALLY TO OUR STOCK.
The price of our common stock has been volatile and has declined significantly and we may face
delisting from Nasdaq.
Due to the futility determination of the Riquent clinical trial, our stock has
experienced significant price and volume volatility since February 2009. Our stock is currently
trading below $0.40 per share and we could continue to experience further declines in our stock
price. Our stock is currently trading below the $1.00 minimum bid price required under Nasdaqs
continued listing requirements. Although Nasdaq has suspended the enforcement of rules requiring a
minimum $1.00 closing bid price and the rules requiring a minimum market value of publicly held
shares, this suspension is currently only in effect through July 19, 2009. We will likely be
non-compliant with Nasdaqs continued listing requirements when this suspension is lifted. If our
stock continues to trade below $1.00 when the temporary suspension is lifted, Nasdaq may commence
delisting procedures against us.
In addition to the minimum bid price rule, the Nasdaq Global Market has several other
continued listing requirements and we currently are not in compliance with the continued listing
standard regarding minimum stockholders equity. We have presented a plan to regain compliance with
the minimum equity requirement, but we cannot be assured that Nasdaq will accept our plan or that
we will be able to successfully execute our plan. Either Nasdaqs refusal to accept our plan or our
inability to successfully execute our plan could result in our delisting from The Nasdaq Global
Market.
17
If we were delisted, the market liquidity of our common stock could be adversely affected
and the market price of our common stock could decline further. Such a delisting could also
adversely affect our ability to effect a strategic transaction, such as a merger with a third
party. In addition, our stockholders ability to trade or obtain quotations on our shares could be
severely limited because of lower trading volumes and transaction delays. These factors could
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.
Our common stock price is volatile and may continue to decline.
The market price of our common stock has been and is likely to continue to be highly
volatile. Market prices for securities of biotechnology and pharmaceutical companies, including
ours, have historically been highly volatile, and the market has from time to time experienced
significant price and volume fluctuations that are unrelated to the operating performance of
particular companies. The following factors, among others, can have a significant effect on the
market price of our securities:
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limited financial resources; |
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announcements regarding mergers or other strategic transactions, as well as rumors and
speculation around the potential events; |
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future sales of significant amounts of our common stock by us or our stockholders; |
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actions or decisions by our creditors; |
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actions or decisions by The Nasdaq Stock Market with respect to the listing of our common stock; |
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developments concerning potential and existing 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.
Failure to achieve and maintain effective internal control over financial reporting in accordance
with Section 404 of the Sarbanes-Oxley Act could have a material adverse effect on our business and
stock price.
Section 404 of the Sarbanes-Oxley Act requires us to evaluate annually the effectiveness
of our internal controls over financial reporting as of the end of each fiscal year and to include
a management report assessing the effectiveness of our internal control over financial reporting in
all annual reports. Section 404 also requires our independent registered public accounting firm to
report on our internal control over financial reporting in our annual reports. We evaluated our
internal control over financial reporting as of December 31, 2008 in order to comply with Section
404 and concluded that our disclosure controls and procedures were effective as of such date. If we
fail to maintain the adequacy of our internal controls, as such standards are modified,
supplemented or amended from time to time, we cannot provide any assurances that we will be able to
conclude in the future that we have effective internal control over financial reporting in
accordance with Section 404. If we fail to achieve and maintain a system of effective internal
control over financial reporting, it could have a material adverse effect on our business and stock
price.
18
Anti-takeover devices may prevent changes in our board of directors and management.
We have in place several anti-takeover devices, including a stockholder rights plan,
which may have the effect of delaying or preventing changes in our management or deterring third
parties from seeking to acquire significant positions in our common stock. For example, one
anti-takeover device provides for a board of directors that is separated into three classes, with
their terms in office staggered over three-year periods. This has the effect of delaying a change
in control of our board of directors without the cooperation of the incumbent board. In addition,
our bylaws require stockholders to give us written notice of any proposal or director nomination
within a specified period of time prior to the annual stockholder meeting, establish certain
qualifications for a person to be elected or appointed to the board of directors during the
pendency of certain business combination transactions, and do not allow stockholders to call a
special meeting of stockholders.
We may also issue shares of preferred stock without further stockholder approval and upon
terms that our board of directors may determine in the future. The issuance of preferred stock
could have the effect of making it more difficult for a third party to acquire a majority of our
outstanding stock, and the holders of such preferred stock could have voting, dividend, liquidation
and other rights superior to those of holders of our common stock.
Future sales of our stock by our stockholders could negatively affect the market price of our
stock.
Sales of our common stock in the public market, or the perception that such sales could
occur, could result in a drop in the market price of our securities. As of May 4, 2009, 65,722,648
shares of our common stock were issued and outstanding.
We cannot estimate the number of shares of common stock that may actually be resold in
the public market because this will depend on the market price for our common stock, the actions of
the selling stockholder and other factors. During February 2009, of our three stockholders who
owned 10% or more of our outstanding common stock as of December 31, 2008, two of them sold all of
their stock ownership positions and one sold a substantial portion of its common stock ownership
position to below 5%.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
On January 20, 2009, we sold 339,104 shares of Series B-1 Preferred Stock to BioMarin Pharma
pursuant to the securities purchase agreement executed on January 4, 2009. Each share was sold for
$22.1171, for an aggregate offering price of $7,500,000. This sale was exempt from registration
with the Securities and Exchange Commission pursuant to Rule 506 of Regulation D promulgated under
the Securities Act of 1933, as amended. The Series B-1 Preferred Stock is convertible into common
stock on a 30:1 basis and automatically converted into 10,173,120 shares of common stock upon
termination of the Development Agreement on March 27, 2009.
19
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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Restated Certificate of Incorporation (1) |
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3.2 |
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Amended and Restated Bylaws (2) |
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3.3 |
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Certificate of Designations of Series A Junior Participating Preferred Stock (3) |
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4.1 |
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Form of Common Stock Certificate (4) |
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4.2 |
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Rights Agreement, dated as of December 3, 1998, between the Company and
American Stock Transfer & Trust Company (5) |
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4.3 |
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Amended and Restated Rights Agreement, dated as of December 2, 2008, between
the Company and American Stock Transfer & Trust Company (3) |
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4.4 |
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Amendment No. 1 to Amended and Restated Rights Agreement, dated as of January
20, 2009, between the Company and American Stock Transfer & Trust Company (7) |
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10.1 |
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Development and Commercialization Agreement, dated as of January 4, 2009, by
and between the Company and BioMarin CF Limited* |
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10.2 |
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Securities Purchase Agreement, dated as of January 4, 2009, by and between the
Company and BioMarin Pharmaceutical Inc.* |
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10.3 |
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Amendment No. 1 to Development and Commercialization Agreement, dated as of
January 4, 2009, by and between the Company and BioMarin CF Limited* |
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10.4 |
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Amendment No. 1 to Securities Purchase Agreement, dated as of January 4, 2009,
by and between the Company and BioMarin Pharmaceutical Inc.* |
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31.1 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Filed herewith. |
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Confidential treatment requested. |
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(1) |
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Previously filed with the Companys Current Report on Form 8-K filed March 1, 2006 and
incorporated by reference herein. |
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(2) |
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Previously filed with the Companys Quarterly Report on Form 10-Q for the quarter ended
September 30, 2000 and incorporated by reference herein. |
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(3) |
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Previously filed with the Companys Registration Statement on Form 8-A/A filed December 4,
2008 and incorporated by reference herein. |
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(4) |
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Previously filed with the Companys Registration Statement on Form S-3 (Registration No.
333-131246) filed January 24, 2006 and incorporated by reference herein. |
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(5) |
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Previously filed with the Companys Registration Statement on Form 8-A (Registration No.
000-24274) filed December 4, 1998 and incorporated by reference herein. |
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(6) |
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Previously filed with the Companys Current Report on Form 8-K filed December 4, 2008 and
incorporated by reference herein. |
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(7) |
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Previously filed with the Companys Registration Statement on Form 8-A/A (Registration No.
000-24274) filed January 26, 2009 and incorporated by reference herein. |
20
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
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La Jolla Pharmaceutical Company
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Date: May 15, 2009 |
/s/ Deirdre Y. Gillespie
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Deirdre Y. Gillespie, M.D. |
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President and Chief Executive Officer
(On behalf of the Registrant) |
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/s/ Gail A. Sloan
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Gail A. Sloan |
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Vice President of Finance and Secretary
(As Principal Financial and Accounting Officer) |
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21
LA JOLLA PHARMACEUTICAL COMPANY
INDEX TO EXHIBITS
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Exhibit |
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Number |
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Description |
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10.1 |
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Development and Commercialization Agreement, dated as of January 4, 2009, by
and between the Company and BioMarin CF Limited* |
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10.2 |
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Securities Purchase Agreement, dated as of January 4, 2009, by and between the
Company and BioMarin Pharmaceutical Inc.* |
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10.3 |
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Amendment No. 1 to Development and Commercialization Agreement, dated as of
January 4, 2009, by and between the Company and BioMarin CF Limited* |
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10.4 |
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Amendment No. 1 to Securities Purchase Agreement, dated as of January 4, 2009,
by and between the Company and BioMarin Pharmaceutical Inc.* |
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31.1 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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31.2 |
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Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 |
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32.1 |
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Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
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* |
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Filed herewith. |
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Confidential treatment requested. |
22