UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
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.
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For the quarterly period ended September 30, 2005
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.
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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
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(State or Other Jurisdiction of
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(I.R.S. Employer
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Incorporation or Organization)
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Identification No.)
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6455 Nancy Ridge Drive
San Diego, CA
(Address of Principal Executive Offices)
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92121
(Zip Code)
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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 is an accelerated filer (as defined in Rule 12b-2 of
the Exchange Act). Yes
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No
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes
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No
þ
The number of shares of the registrants common stock, $0.01 par value per share, outstanding at
October 26, 2005 was 74,152,686.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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September 30,
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December 31,
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2005
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2004
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(Unaudited)
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(See Note)
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ASSETS
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Current assets:
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Cash and cash equivalents
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$
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1,872
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$
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2,861
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Short-term investments
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13,818
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20,204
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Other current assets
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776
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783
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Total current assets
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16,466
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23,848
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Property and equipment, net
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4,519
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6,059
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Patent costs and other assets, net
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3,105
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3,119
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Total assets
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$
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24,090
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$
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33,026
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LIABILITIES AND STOCKHOLDERS EQUITY
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Current liabilities:
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Accounts payable
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$
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489
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$
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1,455
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Accrued clinical/regulatory expenses
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260
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647
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Accrued expenses
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1,370
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2,061
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Accrued payroll and related expenses
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601
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1,210
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Current portion of obligations under capital leases
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14
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Current portion of obligations under notes payable
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646
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922
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Total current liabilities
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3,366
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6,309
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Noncurrent portion of obligations under notes payable
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228
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716
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Commitments:
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Stockholders equity:
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Common stock
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742
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615
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Additional paid-in capital
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274,026
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258,358
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Other comprehensive loss
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(23
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Accumulated deficit
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(254,272
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)
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(232,949
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)
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Total stockholders equity
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20,496
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26,001
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Total liabilities and stockholders equity
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$
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24,090
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$
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33,026
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Note: The condensed consolidated balance sheet at December 31, 2004 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 accounting principles generally accepted in the United
States.
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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Nine Months Ended
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September 30,
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September 30,
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2005
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2004
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2005
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2004
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Expenses:
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Research and development
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$
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4,969
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$
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10,656
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$
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17,499
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$
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24,268
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General and administrative
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1,081
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2,280
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4,224
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5,452
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Total expenses
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6,050
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12,936
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21,723
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29,720
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Loss from operations
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(6,050
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(12,936
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(21,723
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(29,720
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Interest income, net
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123
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104
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400
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145
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Net loss
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$
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(5,927
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$
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(12,832
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$
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(21,323
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$
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(29,575
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Basic and diluted net loss per share
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$
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(.08
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$
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(.21
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$
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(.29
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$
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(.50
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Shares used in computing basic and
diluted net loss per share
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74,041
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61,310
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72,467
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59,135
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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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Nine Months Ended
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September 30,
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2005
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2004
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Operating activities:
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Net loss
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$
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(21,323
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$
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(29,575
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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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1,593
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1,542
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Loss on
write-off/disposal of patents, other assets and property and equipment
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371
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81
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Stock compensation expense
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6
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119
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Accretion of interest income
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(27
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22
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Change in operating assets and liabilities:
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Other current assets
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7
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(8
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Accounts payable and accrued expenses
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(1,657
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)
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3,553
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Accrued clinical/regulatory expenses
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(387
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)
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369
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Accrued payroll and related expenses
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(609
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(572
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)
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Net cash used for operating activities
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(22,026
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(24,469
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Investing activities:
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Purchases of short-term investments
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(23,800
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(35,865
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Sales of short-term investments
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30,236
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31,750
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Additions to property and equipment
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(122
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(1,483
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Increase in patent costs and other assets
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(288
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)
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(517
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Net cash provided by (used for) investing activities
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6,026
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(6,115
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)
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Financing activities:
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Net proceeds from issuance of common stock
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15,789
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29,795
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Payments on obligations under capital leases
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(14
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)
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(66
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Proceeds from issuance of notes payable
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478
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Payments on notes payable
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(764
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)
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(658
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)
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Net cash provided by financing activities
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15,011
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29,549
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Net decrease in cash and cash equivalents
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(989
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)
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(1,035
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)
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Cash and cash equivalents at beginning of period
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2,861
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4,021
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Cash and cash equivalents at end of period
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$
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1,872
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$
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2,986
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Supplemental disclosure of cash flow information:
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Interest paid
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$
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98
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$
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148
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Supplemental schedule of noncash investing and financing activities:
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Net unrealized gains on available-for-sale investments
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$
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23
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$
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16
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2005
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company (the Company) have been prepared in accordance with accounting principles generally
accepted in the United States 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
footnotes required by accounting principles generally accepted in the United States for complete
financial statements. In the opinion of management, all adjustments (consisting of normal
recurring accruals) considered necessary for a fair presentation have been included. Operating
results for the three and nine months ended September 30, 2005 are not necessarily indicative of
the results that may be expected for other quarters or the year ended December 31, 2005. For more
complete financial information, these 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, 2004 included in the Companys Form 10-K filed with the Securities and
Exchange Commission.
2. Accounting Policies
Use of Estimates
The preparation of consolidated financial statements in conformity with accounting principles
generally accepted in the United States requires management to make estimates and assumptions that
affect the amounts reported in the condensed consolidated financial statements and disclosures made
in the accompanying notes to the condensed consolidated financial statements. Actual results could
differ materially from those estimates.
Stock-Based Compensation
As allowed under Statement of Financial Accounting Standard (SFAS) No. 123,
Accounting and
Disclosure of Stock-Based Compensation
, the Company has elected to continue to account for stock
option grants in accordance with Accounting Principles Board Opinion No. 25,
Accounting for Stock
Issued to Employees,
and related interpretations (APB 25). The Company generally grants stock
options for a fixed number of shares to employees and directors with an exercise price equal to the
fair value of the shares at the date of grant and therefore, under APB 25, recognizes no
compensation expense for such stock option grants.
Pro forma information regarding net loss and net loss per share is required by SFAS No. 123. SFAS
No. 123 requires that the information be determined as if the Company has accounted for awards
granted under its employee stock plans after December 31, 1994 under the fair value method
prescribed by SFAS No. 123. The fair value of the options granted was estimated at the date of
grant using a Black-Scholes option pricing model.
The Black-Scholes option valuation model was developed for use in estimating the fair value of
traded options that have no vesting restrictions and are fully transferable. In addition, option
valuation models require the input of highly subjective assumptions including the expected stock
price volatility. Because the Companys stock options have characteristics significantly different
from those of traded options and because changes in the subjective input assumptions can materially
affect the fair value estimate, in managements opinion, the existing models do not necessarily
provide a reliable single measure of the fair value of the Companys stock options.
4
For purposes of pro forma disclosures, the estimated fair value of options is expensed over the
options vesting period. The Companys pro forma information is set forth below (in thousands,
except for net loss per share information):
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Three Months Ended
|
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Nine Months Ended
|
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September 30,
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September 30,
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2005
|
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|
2004
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|
2005
|
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|
2004
|
|
Net loss as reported
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$
|
(5,927
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)
|
|
$
|
(12,832
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)
|
|
$
|
(21,323
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)
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$
|
(29,575
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)
|
Less: Stock-based compensation expense
determined under fair value based method for
all awards
|
|
|
(759
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)
|
|
|
(1,713
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)
|
|
|
(2,988
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)
|
|
|
(5,190
|
)
|
|
|
|
Pro forma net loss
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$
|
(6,686
|
)
|
|
$
|
(14,545
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)
|
|
$
|
(24,311
|
)
|
|
$
|
(34,765
|
)
|
|
|
|
Basic and diluted net loss per share as reported
|
|
$
|
(0.08
|
)
|
|
$
|
(0.21
|
)
|
|
$
|
(0.29
|
)
|
|
$
|
(0.50
|
)
|
|
|
|
Pro forma basic and diluted net loss per share
|
|
$
|
(0.09
|
)
|
|
$
|
(0.24
|
)
|
|
$
|
(0.34
|
)
|
|
$
|
(0.59
|
)
|
|
|
|
The effects of applying SFAS No. 123 for either recognizing compensation expense or providing pro
forma disclosures may not be representative of the effects on reported net loss for future periods.
Options or stock awards issued to non-employees (other than non-employee directors) have been
determined in accordance with SFAS No. 123 and 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 non-employees (other than non-employee directors)
are periodically remeasured as the options vest.
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
. Because the
Company has incurred a net loss for all periods presented in the Condensed Consolidated Statements
of Operations, stock options are not included in the computation of net loss per share because
their effect is anti-dilutive.
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). The Companys
comprehensive net loss totaled $5,927,000 and $12,804,000 for the three-month periods and
$21,300,000 and $29,559,000 for the nine-month periods ended September 30, 2005 and 2004,
respectively.
3. Recently Issued Accounting Standards
In December 2004, the FASB issued SFAS No. 123R,
Share-Based Payment
, which is a revision of SFAS
No. 123. SFAS No. 123R supersedes APB 25 and amends SFAS No. 95,
Statement of Cash Flows
.
Generally, the approach in SFAS No. 123R is similar to the approach described in SFAS No. 123.
However, SFAS No. 123R requires all share-based payments to employees and non-employee directors,
including grants of stock options, to be recognized in the income statement based on their fair
values and requires the use of an option pricing model for estimating fair value, which is
amortized to expense over the service periods. Pro forma disclosure is no longer an alternative.
On April 14, 2005, the United States Securities and Exchange Commission adopted a new rule amending
the compliance dates for SFAS No. 123R. In accordance with the new rule, the accounting provisions
of SFAS No. 123R will be effective for the first annual period beginning after June 15, 2005. The
Company expects to adopt SFAS
5
No. 123R on January 1, 2006. The impact of adoption of SFAS No. 123R cannot be predicted at this
time because it will depend on the amounts of share-based payments granted in the future. However,
had the Company adopted SFAS No. 123R for the period ended September 30, 2005, the net loss would
have been increased by approximately $0.8 million and $3.0 million for the three-month and
nine-month periods ended September 30, 2005, respectively. SFAS No. 123R allows for either
prospective recognition of compensation expense or retrospective recognition, which may extend back
to the original issuance of SFAS No. 123 or only to interim periods in the year of adoption. The
Company is currently evaluating these transition methods.
4. Restructuring Charges
In March 2005, the Company restructured its operations in order to reduce costs. In accordance
with SFAS No. 146,
Accounting for Costs Associated with Exit or Disposal
Activities, as of
September 30, 2005, the Company recorded total restructuring charges of approximately $1.5 million
in connection with the termination of 60 employees (approximately $1.2 million), the impairment of
certain long-term assets (approximately $0.1 million), and retention payments for key executives
(approximately $0.2 million). This action followed an announcement by the Company that, based on
the outcome of a meeting with the United States Food and Drug Administration (the FDA), the
Companys lead drug candidate, Riquent
â
, was unlikely to receive accelerated approval under
the FDAs Subpart H regulation.
Approximately $1.0 million of the total restructuring charges was included in research and
development expense and approximately $0.5 million was included in general and administrative
expense.
As of September 30, 2005, the Company had paid all of the $1.4 million cash restructuring charges
(consisting of approximately $1.2 million in severance and related costs and $0.2 million in
retention payments for key executives). Cash payments in the third quarter of 2005 were for
severance and related charges ($0.2 million) and retention payments for key executives ($0.2
million). The non-cash charge of $0.1 million for write-downs of impaired assets as a result of
the restructuring was included in research and development expense in the first quarter of 2005.
5. Changes in Securities
In February 2005, the Company sold 12,250,000 shares of its common stock in a public offering for
net proceeds of approximately $15.8 million.
6.
Subsequent Event
On October 6, 2005,
the Company entered into a definitive agreement for the sale
of common stock and warrants to purchase common stock to selected
institutional and other accredited investors for gross proceeds of
approximately $66 million, subject to stockholder approval and other closing conditions. The special stockholder meeting is
scheduled for December 2, 2005.
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 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 analyses of clinical results of Riquent, previously known as LJP 394, our drug
candidate for the treatment of systemic lupus erythematosus (lupus) and any other drug candidate
that we may develop, including the results of any trials that are ongoing or that we may initiate
in the future, could result in a finding that these drug candidates are not effective in large
patient populations, do not provide a meaningful clinical benefit, or may reveal a potential safety
issue requiring us to develop new candidates. The analysis of the data from our Phase 3 trial of
Riquent showed that the trial did not reach statistical significance with respect to its primary
endpoint, time to renal flare, or with respect to its secondary endpoint, time to treatment with
high-dose corticosteroids or cyclophosphamide. The results from our clinical trials of Riquent,
including the results of any trials that are ongoing or that we may initiate in the future, may not
ultimately be sufficient to obtain regulatory clearance to market Riquent either in the United
States or Europe, and we may be required to conduct additional clinical studies to demonstrate the
safety and efficacy of Riquent in order to obtain marketing approval. There can be no assurance,
however, that we will have the necessary resources to complete any current or future trials or that
any such trials will sufficiently demonstrate the
6
safety and efficacy of Riquent. Our blood test to measure the binding affinity for Riquent is
experimental, has not been validated by independent laboratories and will likely be reviewed as
part of the Riquent approval process. Our other potential drug candidates are at earlier stages of
development and involve comparable risks. Analysis of our clinical trials could have negative or
inconclusive results. Any positive results observed to date may not be indicative of future
results. In any event, regulatory authorities may require clinical trials in addition to our
current clinical trial, or may not approve our drugs. Our ability to develop and sell our products
in the future may be adversely affected by the intellectual property rights of third parties.
Additional risk factors include the uncertainty and timing of: our clear need for additional
financing or a collaborative agreement; obtaining required regulatory approvals, including delays
associated with any approvals that we may obtain; our ability to pass all necessary FDA
inspections; the further development of our manufacturing
capabilities for clinical studies and possible
commercialization; successfully marketing and selling our products; our lack of manufacturing,
marketing and sales experience; our ability to make use of the orphan drug designation for Riquent;
generating future revenue from product sales or other sources such as collaborative relationships;
future profitability; and our dependence on patents and other proprietary rights. Readers are
cautioned to not place undue reliance upon forward-looking statements, which speak only as of the
date hereof, and we undertake no obligation to update forward-looking statements to reflect events
or circumstances occurring after the date hereof. Interested parties are urged to review the risks
described in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2005, and in other
reports and registration statements that we file with the Securities and Exchange Commission from
time to time.
Developments in 2005
On February 2, 2005, we announced that we had completed a public offering of 12,250,000 shares
of our common stock. The net proceeds to us, after expenses, were approximately $15.8 million.
On March 14, 2005, we announced that, based on the outcome of a meeting with the FDA, Riquent
was unlikely to receive accelerated approval under the FDAs Subpart H regulation. We currently
plan to continue the ongoing clinical benefit trial and expect to continue discussions with the FDA
about ways to enhance the trial, including, as previously announced, the addition of a higher dose
to the study.
On March 29, 2005, we announced that we were implementing a restructuring plan to reduce our
costs. The restructuring plan included a workforce reduction of 60 employees, leaving a current
post-restructuring workforce of 86 employees. Under the plan, we are continuing our ongoing
clinical benefit trial of Riquent without any significant additional patient enrollment or site
expansion and are continuing our small molecule inflammation program. We also are continuing
activities that would allow a filing of a Marketing Authorization Application (the MAA) in
Europe. The termination benefits, primarily severance costs, were approximately $1.5 million, of
which approximately $1.3 million was recorded in the first quarter and the remainder of which was
recorded in the second quarter.
On April 28, 2005, we announced that we had received a notice from the Nasdaq Stock Market
indicating that we were not in compliance with Nasdaq Marketplace Rule 4450(a)(5) (the Minimum Bid
Price Rule) because, as of the date of the notice, the bid price of our common stock had closed
below the minimum $1.00 per share for 30 consecutive business days. In accordance with the Nasdaq
Marketplace Rules, we had 180 calendar days, or until October 24, 2005, to regain compliance with
the Minimum Bid Price Rule. On October 25, 2005, we received a letter from the Nasdaq Listing
Qualifications Department indicating that we were not in compliance with the minimum $1.00 bid
price requirement for continued listing pursuant to Nasdaq Marketplace Rule 4450(a)(5) and are
subject to delisting. We have scheduled a hearing date with the Nasdaq Listing Qualifications
Panel for December 1, 2005, which automatically stays the delisting of our common stock pending the
Panels review and determination. However, we can give no assurances that the Panel will grant our
request for continued listing.
On May 31, 2005, we announced that we had received fast track designation for Riquent for
the treatment of lupus renal disease from the FDA. The FDAs fast track program is designed to
facilitate the development and to expedite the review of new drugs that are intended to treat
serious or life threatening conditions and that demonstrate the potential to address an unmet
medical need.
7
On October 7, 2005, we announced that we had entered into a definitive agreement for the sale
of common stock and warrants to purchase common stock to selected institutional and other
accredited investors for gross proceeds of approximately $66 million, subject to stockholder
approval and other closing conditions. Pursuant to the terms of the agreement, we will issue an aggregate of 88 million shares
of newly-issued common stock and warrants to purchase an aggregate of 22 million shares of common
stock to Essex Woodlands Health Ventures Fund VI, LP, Frazier Healthcare Ventures, Mr. Alejandro
Gonzalez, Special Situations Funds, Domain Public Equity Partners, LP, and Sutter Hill Ventures.
The warrants to be issued at the closing will be immediately exercisable when issued, will have an
exercise price of $1.00 per share and will remain exercisable for five years. In addition to the
warrants issued at the closing, the investors are entitled to receive additional but conditional
warrants to purchase an amount of common stock equal to an aggregate of 5% of our outstanding
shares as of October 6, 2005. The conditional warrants will become exercisable in the event that
the Company completes a financing transaction other than the proposed transaction, the stockholders
do not approve the proposed transaction, the proposed transaction is not closed prior to December
30, 2005, or certain extraordinary transactions occur. Upon the closing of the proposed
transaction, the additional warrants, if issued, will become void and of no effect. In connection
with seeking stockholder approval of the transaction, we expect to seek stockholder approval of an
amendment to our certificate of incorporation to increase the number of authorized shares of common
stock, to amend our current equity incentive plan to, among other matters, increase the number of
shares available for grant under the plan, and to approve a reverse stock split of five for one.
The special stockholder meeting will be held on December 2, 2005.
On October 18, 2005, we announced the status of our development program for Riquent, which
included an overview of the ongoing clinical benefit trial, a regulatory update and a discussion of
our goals for the upcoming 12 months. Among other matters, we announced our goals for the next 12
months which include completing the recently announced financing in December 2005, restarting
enrollment in the United States for Riquents Phase 3 trial early in 2006 after a final review of
the revised protocol by the FDA, expanding the study to Europe and Asia, submitting the MAA for
Europe in the first half of 2006, and obtaining data on the ability of higher doses
of Riquent to reduce further the levels of antibodies to dsDNA around the end of next year. In addition, we expect to be able
to conduct an interim analysis for efficacy at a point in time when approximately 70% of the
projected number of renal flares has been observed.
Overview
In light of the outcome of a meeting with the FDA in March 2005, at which we learned that it
is unlikely that we would receive accelerated approval for Riquent under the FDAs Subpart H
regulation, we will need to successfully complete the ongoing clinical benefit study of Riquent,
which we commenced in August 2004, prior to any FDA approval decisions. We expect that the ongoing
clinical benefit trial will involve approximately 500 to 600 patients, may cost at least $60
million, and will take several years to complete. If we do not receive funding from the sale of
securities or a collaborative partner or obtain other financing in the near future, we will not
have sufficient resources to complete the ongoing clinical benefit trial. On October 6, 2005, we
entered into a Securities Purchase Agreement that provides for the sale of common stock and
warrants to purchase common stock to selected institutional and other accredited investors for
gross proceeds of approximately $66 million. Pursuant to the terms of the agreement, we will issue
an aggregate of 88 million shares of newly-issued common stock and warrants to purchase an
aggregate of 22 million shares of common stock to Essex Woodlands Health Ventures Fund VI, LP,
Frazier Healthcare Ventures, Mr. Alejandro Gonzalez, Special Situations Funds, Domain Public Equity
Partners, LP, and Sutter Hill Ventures. The sale of securities is expected to close in December
2005, and is subject to stockholder approval, remaining listed on either the Nasdaq National Market
or the Nasdaq Capital Market, and other customary closing conditions. For additional information
about our current financial resources, please refer to the discussion below under the heading
Liquidity and Capital Resources.
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
8
cash balances for our working capital. Based on the results of the FDAs prior review of our
New Drug Application (NDA) for Riquent, and depending on the outcome of our further discussions
with the FDA and other regulatory agencies and our continuing analysis of the data from our
clinical trials of Riquent, our research and development expenses may increase significantly in the
future should we obtain additional funding. For example, we have initiated a clinical trial of
Riquent that the FDA has indicated appears to satisfy the requirement that we conduct an additional
randomized, double-blind study. This study is expected to involve approximately 500 to 600
patients, may cost at least $60 million, and is expected to take several years to complete. In
addition, our research and development expenses may increase if we initiate any additional clinical
studies of Riquent or if we increase our activities related to any additional drug candidates. Our
activities to date are not as broad in depth or scope as the activities we may undertake in the
future, and our historical operations and the financial information included in this report are not
necessarily indicative of our future operating results or financial condition.
We expect our net loss to fluctuate from quarter to quarter as a result of the timing of
expenses incurred and the revenues earned from any potential collaborative arrangements we may
establish. Some of these fluctuations may be significant. As of September 30, 2005, our
accumulated deficit was approximately $254.3 million.
Our business is subject to significant risks, including, but not limited to, our clear need
for additional financing or a collaborative partner, the risks inherent in research and development
efforts, including clinical trials, the lengthy, expensive and uncertain process of seeking
regulatory approvals, uncertainties associated with both obtaining and enforcing patents, the
potential enforcement of the patent rights of others against us, uncertainties regarding government
reforms regarding product pricing and reimbursement levels, technological change, competition,
manufacturing uncertainties, our lack of marketing experience, the uncertainty of receiving future
revenue from product sales or other sources such as collaborative relationships, and the
uncertainty of future profitability. Even if our product candidates appear promising at an early
stage of development, they may not reach the market for numerous reasons, including the
possibilities that the products will be ineffective or unsafe during clinical trials, will fail to
receive necessary regulatory approvals, will be difficult to manufacture on a large scale, will be
uneconomical to market or will be precluded from commercialization by the proprietary rights of
third parties or competing products.
Results of Operations
For the three months ended September 30, 2005, research and development expenses decreased to
$5.0 million from $10.7 million for the same period in 2004. The decrease was primarily due to a
decrease in expenses related to the purchase of raw materials for the production of Riquent. In
addition, there were cost savings related to the termination of 44 research and development
personnel in connection with the March 2005 restructuring. For the nine months ended September 30,
2005, research and development expenses decreased to $17.5 million from $24.3 million for the same
period in 2004 primarily due to a decrease in expenses related to the purchase of raw materials as
noted above. There was also a decrease in consulting and professional outside services resulting
from the decrease in activity.
Research and development expense of $5.0 million for the three months ended September 30, 2005
consisted of $3.9 million for lupus research and development related expense and $1.1 million for
other research and development related expense. There were no expenses related to thrombosis
research and development in the third quarter. Research and development expense of $17.5 million
for the nine months ended September 30, 2005 consisted of $14.4 million for lupus research and
development related expense, $0.5 million for thrombosis research and development related expense,
and $2.6 million for other research and development related expense. For the three and nine months
ended September 30, 2005, total lupus research and development expense consisted primarily of
salaries, severance and other costs related to research, manufacturing and clinical personnel,
costs related to the clinical studies of Riquent, and consulting and professional outside services.
Total thrombosis related research and development expense consisted primarily of salaries and
severance for research and development personnel. Total other research and development expense
consisted primarily of salaries, severance and other costs related to research and development
personnel, research supplies, rent and lease expense, and consulting and professional outside
services.
9
Our research and development expense may increase significantly in the future if we obtain
additional funding. For example, we have initiated a clinical trial of Riquent that the FDA has
indicated appears to satisfy the requirement that we conduct an additional randomized, double-blind
study. This study is expected to involve approximately 500 to 600 patients, may cost at least $60
million, and is expected to take several years to complete. Additionally, our research and
development expenses may increase significantly if we initiate any additional clinical studies of
Riquent or if we increase our activities related to the development of additional drug candidates.
For the three months ended September 30, 2005, general and administrative expense decreased to
$1.1 million from $2.3 million for the same period in 2004. The decrease was primarily due to a
decrease in consulting fees for pre-marketing and other general corporate activities. In addition,
there were cost savings related to the termination of 16 general and administrative personnel in
connection with the March 2005 restructuring. General and administrative expenses decreased to
$4.2 million for the nine months ended September 30, 2005 from $5.5 million for the same period in
2004. This decrease was primarily due to the decrease in consulting fees noted above, partially
offset by the cost of termination benefits, mainly severance, of approximately $0.5 million, in
connection with the termination of 16 general and administrative personnel. If we obtain
additional funding, general and administrative expense may increase in the future to support
clinical trials and possible increases in manufacturing and research and development activities.
Interest income, net was $0.1 million for the three months ended September 30, 2005 and
September 30, 2004. Interest income, net increased to $0.4 million for the nine months ended
September 30, 2005 from $0.1 million for the same period in 2004 due to higher average interest
rates in 2005 compared to 2004 and realized losses on the sale of investments recognized in the
first quarter of 2004.
Liquidity and Capital Resources
From inception through September 30, 2005, we have incurred a cumulative net loss of
approximately $254.3 million and have financed our operations through private and public offerings
of securities, revenues from collaborative agreements, equipment financings and interest income on
invested cash balances. From inception through September 30, 2005, we have raised approximately
$273.9 million in net proceeds from sales of equity securities.
At September 30, 2005, we had $15.7 million in cash, cash equivalents and short-term
investments, as compared to $23.1 million at December 31, 2004. Our working capital at September
30, 2005 was $13.1 million, as compared to $17.5 million at December 31, 2004. The decrease in
cash, cash equivalents and short-term investments resulted from the use of our financial resources
to fund our clinical and manufacturing activities, research and development efforts and for other
general corporate purposes, partially offset by the net proceeds of $15.8 million we received from
the sale of 12,250,000 shares of our common stock in February 2005. We invest our cash in United
States government-backed securities, money market funds and debt instruments of financial
institutions and corporations with strong credit ratings. As of September 30, 2005, we classified
all of our investments as available-for-sale securities because we expect to sell them in order to
support our current operations regardless of their maturity dates. As of September 30, 2005,
available-for-sale securities and cash equivalents of $1.6 million have stated maturity dates of
one year or less and $13.0 million have maturity dates after one year. See Quantitative and
Qualitative Disclosures About Market Risk, below.
As of September 30, 2005, we had acquired an aggregate of $15.0 million in property and
equipment, of which approximately $3.5 million of equipment is financed under notes payable
obligations. In addition, we lease our office and laboratory facilities and certain equipment
under operating leases. In 2003, we entered into a $1.4 million purchase commitment with a
potential third party manufacturer of materials for Riquent. The purpose of the agreement was to
qualify the manufacturer as a manufacturer that we could use in the commercial production of
Riquent if we obtained regulatory approval. As a result of our announcement that, based on the
outcome of a meeting with the FDA, Riquent is unlikely to receive accelerated approval under the
FDAs Subpart H regulation, we believe that we have adequate capacity to meet our near term
manufacturing requirements and that the third party manufacturing
10
capacity is not currently required. Accordingly, the table below only includes the purchase
commitment cancellation fee of $0.4 million. We have also entered into non-cancelable purchase
commitments for an aggregate of $0.1 million with third-party manufacturers of materials to be used
in the production of Riquent for our ongoing clinical benefit trial and for other purposes. We
intend to use our current financial resources to fund our obligations under these purchase
commitments. In the future, we may increase our investments in property and equipment if we obtain
additional funding and expand our research and development and manufacturing facilities and
capabilities.
The following table summarizes our contractual obligations at September 30, 2005. Long-term
debt obligations include interest.
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|
|
|
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|
|
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|
|
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|
|
|
|
|
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Payment due by period (in thousands)
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|
|
|
|
|
Less than
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|
|
|
|
|
|
|
|
|
More than
|
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|
|
Total
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|
|
1 Year
|
|
|
1-3 Years
|
|
|
3-5 Years
|
|
|
5 Years
|
|
Long-Term Debt Obligations
|
|
$
|
927
|
|
|
$
|
690
|
|
|
$
|
237
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|
|
$
|
|
|
|
$
|
|
|
Operating Lease Obligations
|
|
|
3,146
|
|
|
|
786
|
|
|
|
2,360
|
|
|
|
|
|
|
|
|
|
Purchase Obligations
|
|
|
539
|
|
|
|
539
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|
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
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Total
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|
$
|
4,612
|
|
|
$
|
2,015
|
|
|
$
|
2,597
|
|
|
$
|
|
|
|
$
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We intend to use our current limited financial resources to fund our current clinical
trial of Riquent at its current enrollment level, limited manufacturing and research and
development activities, and for working capital and other general corporate purposes. If we
successfully complete the recently announced financing, we expect to expand our Riquent development
activities, including restarting patient enrollment in the United States early in 2006 after a
final review of the revised protocol by the FDA, expanding the study to Europe and Asia, submitting
the MAA for Europe in the first half of 2006, and obtaining data on the ability of higher doses
of Riquent to reduce further the levels of antibodies to dsDNA around
the end of next year. We may also expend
resources on possible future clinical trials. The amounts that we actually spend for each purpose
may vary significantly depending on numerous factors, including the timing of any regulatory
applications and approvals, the outcome of our meetings with regulatory authorities, the continued
analysis of the clinical trial data of Riquent, results from current and future clinical trials,
and technological developments. Expenditures also will depend on any establishment of
collaborative arrangements and contract research as well as the availability of other funding or
financings. If our cash requirements exceed our current projections, we may need additional
financing sooner than currently expected. There can be no assurance that future funds will be
available to us on acceptable terms, if at all. In the future, it is possible that we will not have
adequate resources to support continuation of our business activities.
In March 2005, we implemented a restructuring plan that included a reduction in our workforce
of 60 employees and the cessation of enrollment and site expansion for our ongoing clinical benefit
trial of Riquent. We anticipate that our existing cash, cash investments, and interest earned
thereon, will be sufficient to fund our operations as currently planned into the first quarter of
2006. This projection is based on the assumption that we do not raise any additional funds, either
through the sale of additional securities or a collaborative agreement with a corporate partner,
that we do not engage in any significant commercialization activities, and that we entirely exhaust
our cash resources. If we do not secure additional funds in the near future, we may sell or license
our assets, merge with another entity, elect to take one or more significant cost reducing
measures, including significantly reducing our workforce, halting the ongoing clinical benefit
trial of Riquent, reducing the expenses associated with our small molecule development program, or
seek protection under relevant bankruptcy laws.
On October 6, 2005, we entered into a Securities Purchase Agreement that provides for the sale
of 88 million shares of common stock and warrants to purchase 22 million shares of common stock to
selected institutional and other accredited investors for gross proceeds of approximately $66
million. The sale of securities is expected to close in December 2005, and is subject to
stockholder approval, remaining listed on either the Nasdaq National Market or the Nasdaq Capital
Market, and other customary closing conditions.
We have no current means of generating cash flow from operations. Our lead drug candidate,
Riquent, will not generate revenues, if at all, until it has received regulatory approval and has
been successfully manufactured, marketed and sold. This process, if completed, could take a
significant
11
amount of time. Our other drug candidates are much less developed than Riquent. There can be no
assurance that our product development efforts with respect to Riquent or any other drug candidate
will be successfully completed, that required regulatory approvals will be obtained or that any
product, if introduced, will be successfully marketed or achieve commercial acceptance.
Accordingly, we must continue to rely on outside sources of financing to meet our capital needs for
the foreseeable future.
We will continue to seek capital through any number of means, including by issuing our equity
securities and by establishing one or more collaborative arrangements. However, there can be no
assurance that additional financing will be available to us on acceptable terms, if at all, and our
negotiating position in capital-raising efforts will likely worsen as we continue to use existing
resources or if the development of Riquent is further delayed or terminated. If we obtain
additional funding through sales of securities, your investment in us will be diluted, and dilution
can be particularly substantial when the price of our common stock is low. There is also no
assurance that we will be able to enter into a collaborative agreement.
ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We invest our excess cash in interest-bearing investment-grade securities which we sell from
time to time to support our current operations. We do not utilize derivative financial
instruments, derivative commodity instruments or other market risk sensitive instruments, positions
or transactions in any material fashion. Although the investment-grade securities that we hold are
subject to changes in the financial standing of the issuer of such securities, we do not believe
that we are subject to any material risks arising from the maturity dates of the debt instruments
or changes in interest rates because the interest rates of the securities in which we invest that
have a maturity date greater than one year are reset periodically within time periods not exceeding
49 days. We currently do not invest in any securities that are materially and directly affected by
foreign currency exchange rates or commodity prices.
ITEM 4. CONTROLS AND PROCEDURES
Our management, with the participation of our principal executive and principal financial
officers, has evaluated the effectiveness of our disclosure controls and procedures as of September
30, 2005. Based on this evaluation, our principal executive and principal financial officers
concluded that our disclosure controls and procedures were effective as of September 30, 2005.
There was no change in our internal control over financial reporting that occurred during the
quarter ended September 30, 2005 that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
12
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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Amended and Restated Certificate of Incorporation of the Company (1)
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3.2
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Certificate of Amendment to Certificate of Incorporation of the Company (28)
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3.3
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Amended and Restated Bylaws of the Company (2)
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4.1
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Rights Agreement dated as of December 3, 1998 between the Company and
American Stock Transfer & Trust Company (3)
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4.2
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Certificate of Designation, Preferences and Rights of Series A Junior
Participating Preferred Stock of the Company (4)
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4.3
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Amendment to Rights Agreement, effective as of July 21, 2000, between the
Company and American Stock Transfer & Trust Company (5)
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|
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4.4
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Registration Rights Agreement by and among, among others, the Company,
Essex Woodlands Health Ventures Fund VI, LP, Frazier Healthcare Ventures,
Alejandro Gonzalez, Special Situations Funds, Domain Public Equity
Partners, LP, and Sutter Hill Ventures, dated October 6, 2005 (29)
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4.5
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Form of Contingent Warrants issued on October 6, 2005 (29)
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10.1
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Steven B. Engle Employment Agreement (6)*
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10.2
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Amendment No. 1 to Steven B. Engle Employment Agreement (7)*
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10.3
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Amendment No. 2 to Steven B. Engle Employment Agreement (12)*
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10.4
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Amendment No. 3 to Steven B. Engle Employment Agreement (17)*
|
|
|
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10.5
|
|
Form of Directors and Officers Indemnification Agreement*
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10.6
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Industrial Real Estate Lease effective July 27, 1992, by and between the
Company and BRE Properties, Inc. (6)
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10.7
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|
First Amendment to Lease dated March 15, 1993 by and between the Company
and BRE Properties, Inc. (6)
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|
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10.8
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|
La Jolla Pharmaceutical Company 1994 Stock Incentive Plan (Amended and
Restated as of May 16, 2003) (17)*
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|
|
|
10.9
|
|
La Jolla Pharmaceutical Company 1995 Employee Stock Purchase Plan (Amended
and Restated as of May 19, 2005) (28)*
|
|
|
|
10.10
|
|
Second Amendment to Lease, dated July 18, 1994, by and between the Company
and BRE Properties, Inc. (9)
|
|
|
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10.11
|
|
Third Amendment to Lease, dated January 26, 1995, by and between the
Company and BRE Properties, Inc. (10)
|
|
|
|
10.12
|
|
Building Lease Agreement, effective November 1, 1996, by and between the
Company and WCB II-S BRD Limited Partnership (11)
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|
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10.13
|
|
Supplement to employment offer letter for Matthew Linnik, Ph.D. (12)*
|
|
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10.14
|
|
Supplement to employment offer letter for Theodora Reilly (13)*
|
|
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|
10.15
|
|
Supplement to employment offer letter for Paul Jenn, Ph.D. (13)*
|
|
|
|
10.16
|
|
Supplement to employment offer letter for Bruce K. Bennett, Jr. (14)*
|
|
|
|
10.17
|
|
Supplement to employment offer letter for Kenneth R. Heilbrunn (8)*
|
|
|
|
10.18
|
|
Supplement to employment offer letter for Josefina Elchico (25)*
|
|
|
|
10.19
|
|
Master Security Agreement, effective September 6, 2002, between the Company
and General Electric Capital Corporation (15)
|
|
|
|
10.20
|
|
Promissory Note, dated as of September 26, 2002, between the Company and
General Electric Capital Corporation (15)
|
13
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
10.21
|
|
Amendment to Promissory Note, effective as of September 27, 2002, between
the Company and General Electric Capital Corporation (15)
|
|
|
|
10.22
|
|
Promissory Note, dated as of December 30, 2002, between the Company and
General Electric Capital Corporation (16)
|
|
|
|
10.23
|
|
Promissory Note, dated as of April 23, 2003, between the Company and
General Electric Capital Corporation (16)
|
|
|
|
10.24
|
|
Promissory Note, dated as of June 27, 2003, between the Company and General
Electric Capital Corporation (17)
|
|
|
|
10.25
|
|
Promissory Note, dated as of September 26, 2003, between the Company and
General Electric Capital Corporation (18)
|
|
|
|
10.26
|
|
Promissory Note, dated as of December 18, 2003, between the Company and
General Electric Capital Corporation (22)
|
|
|
|
10.27
|
|
Underwriting Agreement, dated as of August 7, 2003, between the Company and
Pacific Growth Equities, LLC (19)
|
|
|
|
10.28
|
|
Underwriting Agreement, dated as of February 19, 2004, between the Company
and Pacific Growth Equities, LLC (21)
|
|
|
|
10.29
|
|
Form of Registration Rights Agreement, dated January 2002, between the
Company and the initial purchasers (20)
|
|
|
|
10.30
|
|
Form of Stock Purchase Agreement, dated January 2002, between the Company
and the initial purchasers (20)
|
|
|
|
10.31
|
|
Form of Registration Rights Agreement, dated February 5, 2001, between the
Company and the initial purchasers (18)
|
|
|
|
10.32
|
|
Form of Stock Purchase Agreement, dated February 5, 2001, between the
Company and the initial purchasers (18)
|
|
|
|
10.33
|
|
Form of Registration Rights Agreement, dated July 19, 2000, between the
Company and the initial purchasers (18)
|
|
|
|
10.34
|
|
Form of Stock Purchase Agreement, dated July 19, 2000, between the Company
and the initial purchasers (18)
|
|
|
|
10.35
|
|
Form of Registration Rights Agreement, dated February 10, 2000, between the
Company and the initial purchasers (18)
|
|
|
|
10.36
|
|
Form of Stock Purchase Agreement, dated February 10, 2000, between the
Company and the initial purchasers (18)
|
|
|
|
10.37
|
|
Supplement to employment offer letter for Gail A. Sloan (23)*
|
|
|
|
10.38
|
|
Promissory Note, dated as March 31, 2004, between the Company and General
Electric Capital Corporation (23)
|
|
|
|
10.39
|
|
Promissory Note, dated as June 25, 2004, between the Company and General
Electric Capital Corporation (24)
|
|
|
|
10.40
|
|
Fourth Amendment to Lease, dated July 8, 2004, by and between the Company
and EOP-Industrial Portfolio, LLC (24)
|
|
|
|
10.41
|
|
First Amendment to Lease, dated May 4, 2001, by and between the Company and
Spieker Properties, L.P. (24)
|
|
|
|
10.42
|
|
Second Amendment to Lease, dated July 8, 2004, by and between the Company
and EOP-Industrial Portfolio, LLC (24)
|
|
|
|
10.43
|
|
La Jolla Pharmaceutical Company 2004 Equity Incentive Plan (Amended and
Restated as of May 19, 2005) (28)*
|
|
|
|
10.44
|
|
Form of option grant under the La Jolla Pharmaceutical Company 2004 Equity
Incentive Plan (27)*
|
|
|
|
10.45
|
|
Promissory Note, dated as of September 28, 2004, by and between the Company
and General Electric Capital Corporation (25)
|
14
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
10.46
|
|
Underwriting Agreement, dated January 28, 2005, by and between the Company
and Pacific Growth Equities, LLC (26)
|
|
|
|
10.47
|
|
Securities Purchase Agreement by and among, among others, the Company,
Essex Woodlands Health Ventures Fund VI, LP, Frazier Healthcare Ventures,
Alejandro Gonzalez, Special Situations Funds, Domain Public Equity
Partners, LP, and Sutter Hill Ventures, dated October 6, 2005 (29)
|
|
|
|
10.48
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Steven B. Engle, dated October 6, 2005 (29)*
|
|
|
|
10.49
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Matthew D. Linnik, Ph.D., dated October 6, 2005 (29)*
|
|
|
|
10.50
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Bruce K. Bennett, dated October 6, 2005 (29)*
|
|
|
|
10.51
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Josefina T. Elchico, dated October 6, 2005 (29)*
|
|
|
|
10.52
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Paul C. Jenn, Ph.D., dated October 6, 2005 (29)*
|
|
|
|
10.53
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Theodora Reilly, dated October 6, 2005 (29)*
|
|
|
|
10.54
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Gail A. Sloan, dated October 6, 2005 (29)*
|
|
|
|
10.55
|
|
Retention Agreement, by and between La Jolla Pharmaceutical Company and
Andrew Wiseman, Ph.D., dated October 6, 2005 (29)*
|
|
|
|
31.1
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
31.2
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.1
|
|
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
*
|
|
This exhibit is a management contract or compensatory plan or arrangement.
|
|
(1)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 1999 and incorporated by reference herein.
|
|
(2)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 2000 and incorporated by reference herein.
|
|
(3)
|
|
Previously filed with the Companys Registration Statement on Form 8-A (No. 000-24274)
as filed with the Securities and Exchange Commission on December 4, 1998.
|
|
(4)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 1999 and incorporated by reference herein.
|
|
(5)
|
|
Previously filed with the Companys report on Form 8-K filed on January 26, 2001 and
incorporated by reference herein. The changes effected by the Amendment are also reflected
in the Amendment to Application for Registration on Form 8-A/A filed on January 26, 2001.
|
|
(6)
|
|
Previously filed with the Companys Registration Statement on Form S-1 (No. 33-76480)
as declared effective by the Securities and Exchange Commission on June 3, 1994.
|
|
(7)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 1997 and incorporated by reference herein.
|
|
(8)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 2002 and incorporated by reference herein.
|
|
(9)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 1994 and incorporated by reference herein.
|
|
(10)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
March 31, 1995 and incorporated by reference herein.
|
|
(11)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 1996 and incorporated by reference herein.
|
15
|
|
|
(12)
|
|
Previously filed with the Companys annual report on Form 10-K for the fiscal year
ended December 31, 1999 and incorporated by reference herein.
|
|
(13)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 2001 and incorporated by reference herein.
|
|
(14)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
March 31, 2002 and incorporated by reference herein.
|
|
(15)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 2002 and incorporated by reference herein.
|
|
(16)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
March 31, 2003 and incorporated by reference herein.
|
|
(17)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 2003 and incorporated by reference herein.
|
|
(18)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 2003 and incorporated by reference herein.
|
|
(19)
|
|
Previously filed with the Companys Current Report on Form 8-K filed August 12, 2003
and incorporated by reference herein.
|
|
(20)
|
|
Previously filed with the Companys Current Report on Form 8-K filed January 16, 2002
and incorporated by reference herein.
|
|
(21)
|
|
Previously filed with the Companys Current Report on Form 8-K filed February 20, 2004
and incorporated by reference herein.
|
|
(22)
|
|
Previously filed with the Companys annual report on Form 10-K for the fiscal year
ended December 31, 2003 and incorporated by reference herein.
|
|
(23)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
March 31, 2004 and incorporated by reference herein.
|
|
(24)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
June 30, 2004 and incorporated by reference herein.
|
|
(25)
|
|
Previously filed with the Companys quarterly report on Form 10-Q for the quarter ended
September 30, 2004 and incorporated by reference herein.
|
|
(26)
|
|
Previously filed with the Companys Current Report on Form 8-K filed January 28, 2005
and incorporated by reference herein.
|
|
(27)
|
|
Previously filed with the Companys annual report on Form 10-K for the year ended
December 31, 2004 and incorporated by reference herein.
|
|
(28)
|
|
Previously filed with the Companys Current Report on Form 8-K filed May 20, 2005 and
incorporated by reference herein.
|
|
(29)
|
|
Previously filed with the Companys Current Report on Form 8-K filed October 7, 2005
and incorporated by reference herein.
|
16
SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
La Jolla Pharmaceutical Company
|
|
|
|
Date: November 4, 2005
|
|
/s/ Steven B. Engle
|
|
|
|
|
|
Steven B. Engle
|
|
|
Chairman and Chief Executive Officer
|
|
|
(On behalf of the Registrant)
|
|
|
|
|
|
/s/ Gail A. Sloan
|
|
|
|
|
|
Gail A. Sloan
|
|
|
Vice President of Finance and Secretary
|
|
|
(As Principal Financial and Accounting Officer)
|
17
LA JOLLA PHARMACEUTICAL COMPANY
INDEX TO EXHIBITS
|
|
|
Exhibit
|
|
|
Number
|
|
Description
|
10.5
|
|
Form of Directors and Officers Indemnification Agreement*
|
|
|
|
31.1
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
31.2
|
|
Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.1
|
|
Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
Exhibit 10.5
INDEMNIFICATION AGREEMENT
This Indemnification Agreement (this
Agreement
) is made as of this
day of
, 2005 by
and between La Jolla Pharmaceutical Company (the
Company
) and
(
Indemnitee
).
RECITALS
WHEREAS, the Board of Directors has determined that in order to attract and retain qualified
persons as directors and officers of the Company, it is in the best interests of the Company and
its stockholders to indemnify such persons for claims and actions against them arising out of their
service to and activities on behalf of the Company;
WHEREAS, the bylaws of the Company provide for indemnification of its officers and directors
to the fullest extent permitted by applicable law, and the Company wishes to clarify and enhance
the rights and obligations of the Company and Indemnitee with respect to indemnification;
WHEREAS, the Company has elected to follow the corporate governance practices and procedures
of the Delaware General Corporation Law (the
DGCL
), as the same may be amended from time to time;
WHEREAS, in order to induce and encourage experienced and capable persons such as Indemnitee
to serve and continue to serve as directors and officers of the Company and in any other capacity
with respect to the Company, and to otherwise promote the desirable end that such persons will
resist what they consider unjustified lawsuits and claims made against them in connection with the
good faith performance of their duties to the Company, with the knowledge that certain costs,
judgments, penalties, fines, liabilities and expenses incurred by them in their defense of such
litigation will be borne by the Company and that they will receive the maximum protection against
such risks and liabilities as may be afforded by applicable law, the Board of Directors of the
Company has determined that this Agreement is reasonable, prudent and necessary to promote and
ensure the best interests of the Company and its stockholders; and
WHEREAS, the Company desires to have Indemnitee continue to serve as a director or officer of
the Company free from undue concern for unpredictable, inappropriate or unreasonable legal risks
and personal liabilities by reason of Indemnitee acting in good faith in the performance of
Indemnitees duties to the Company; and Indemnitee desires to continue to serve the Company.
NOW, THEREFORE, in consideration of Indemnitees continued service as a director or officer of
the Company, the parties hereto agree as follows:
AGREEMENT
1.
Indemnity of Indemnitee
. The Company hereby agrees to hold harmless and indemnify
Indemnitee to the fullest extent permitted by the DGCL and the bylaws of the Company, as each may
be amended from time to time. In furtherance of the foregoing indemnification, and without
limiting the generality thereof:
(a)
Third party proceedings
. Indemnitee shall be entitled to the rights of indemnification
provided in this
Section 1(a)
if, by reason of his Corporate Status (
as defined in
Section 15
), he is, or is threatened to be made, a party to or participant in any
Proceeding (
as defined in
Section
15
) other than a Proceeding by or in the right of the Company. Pursuant to this
Section 1(a)
, and to the
extent allowed by applicable law, Indemnitee shall be indemnified
against all Expenses (
as defined in
Section 15
), judgments, penalties, fines and amounts
paid in settlement actually and reasonably incurred by him or on his behalf in connection with such
Proceeding or any claim, issue or matter therein, if he acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the Company and, with respect
to any criminal Proceeding, had no reasonable cause to believe his conduct was unlawful.
(b)
Proceedings by or in the right of the Company
. Indemnitee shall be entitled to the rights
of indemnification provided in this
Section 1(b)
if, by reason of his Corporate Status, he
is, or is threatened to be made, a party to or participant in any Proceeding brought by or in the
right of the Company to procure a judgment in its favor. Pursuant to this
Section 1(b)
,
Indemnitee shall be indemnified against all Expenses actually and reasonably incurred by him or on
his behalf in connection with such Proceeding if he acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the Company;
provided,
however,
that, if applicable law so provides, no indemnification against such Expenses shall be
made in respect of any claim, issue or matter in such Proceeding as to which Indemnitee shall have
been adjudged to be liable to the Company unless, and only to the extent, that the Court of
Chancery of the State of Delaware or the court in which such Proceeding shall have been brought or
is pending, shall determine upon application that, despite the adjudication of liability but in
view of all the circumstances of the case, Indemnitee is fairly and reasonably entitled to
indemnification for such costs, judgments, penalties, fines, liabilities and Expenses as such court
shall deem proper.
(c)
Indemnification for expenses of a party who is wholly or partly successful
.
Notwithstanding any other provision of this Agreement, to the extent that Indemnitee is, by reason
of his Corporate Status, a party to a Proceeding and is successful, on the merits or otherwise, in
any such Proceeding, he shall be indemnified to the maximum extent permitted by applicable law
against all Expenses actually and reasonably incurred by him or on his behalf in connection
therewith. If Indemnitee is not wholly successful in such proceeding but is successful, on the
merits or otherwise, as to one or more but less than all claims, issues or matters in such
Proceeding, the Company shall indemnify Indemnitee against all Expenses actually and reasonably
incurred by him or on his behalf in connection with each successfully resolved claim, issue or
matter. For purposes of this Section and without limitation, the termination of any claim, issue
or matter in such a Proceeding by dismissal with or without prejudice, shall be deemed to be a
successful result as to such claim, issue or matter.
(d)
Additional Indemnity
. Notwithstanding any limitation in
Section 1(a), (b) or (c)
,
the Company shall indemnify Indemnitee to the fullest extent permitted by law if Indemnitee is a
party to or threatened to be made a party to any Proceeding (including a Proceeding by or on behalf
of the Company to procure a judgment in its favor) against all Expenses, judgments, fines and
amounts paid in settlement actually and reasonably incurred by Indemnitee in connection with the
Proceeding;
provided that
, indemnification of Indemnitee shall be made by the Company only as
authorized in the specific case upon a determination that the indemnification of Indemnitee is
proper under the circumstances because Indemnitee met the applicable standard of conduct. For
purposes of this
Section 1(d)
, the meaning of the phrase to the fullest extent permitted
by law shall include, but not be limited to:
(i) to the fullest extent permitted by the provisions of the DGCL that authorize or
contemplate additional indemnification by agreement (or the corresponding provision of any
amendment to or successor or substitute provision of the DGCL); and
(ii) to the fullest extent authorized or permitted by any amendment to the DGCL or by any
successor or substitute rule, law or provision adopted after the date of this Agreement that
increase the extent to which a corporation may indemnify it officers and directors.
2
2.
Exclusions
. Notwithstanding any provision of
Section 1
to the contrary, no
indemnity shall be paid by the Company:
(a) with respect to remuneration paid to Indemnitee if it shall be determined by a final
judgment or other final adjudication that such remuneration was in violation of law;
(b) on account of any suit in which judgment is rendered against Indemnitee for an accounting
of profits made from the purchase or sale by Indemnitee of securities of the Company pursuant to
the provisions of Section 16(b) of the Securities Exchange Act of 1934, as amended, or similar
provisions of any federal, state or local statutory law;
(c) on account of Indemnitees conduct which is finally adjudged to have been knowingly
fraudulent or deliberately dishonest, or to constitute willful misconduct; or
(d) if a final decision by a court having jurisdiction in the matter shall determine that such
indemnification is not lawful.
3.
Contribution
. If the indemnification provided in
Section 1
is unavailable
and may not be paid to Indemnitee for any reason (other than those set forth in Section
2(a),
(b) and (c)
), then with respect to any Proceeding in which the Company is jointly liable with
Indemnitee (or would be if joined in such Proceeding), the Company shall contribute to the amount
of Expenses, judgments, fines and amounts paid in settlement actually and reasonably incurred and
paid or payable by Indemnitee to the extent allowed by applicable law, in such proportion as is
appropriate to reflect (i) the relative benefits received by the Company on the one hand and by the
Indemnitee on the other hand from the transaction from which such Proceeding arose and (ii) the
relative fault of the Company on the one hand and of the Indemnitee on the other hand in connection
with the events which resulted in such Expenses, judgments, fines or settlement amounts, as well as
any other relevant equitable considerations. The relative fault of the Company on the one hand and
of the Indemnitee on the other hand shall be determined by reference to, among other things, the
parties relative intent, knowledge, access to information and opportunity to correct or prevent
the circumstances resulting in such Expenses, judgments, fines or settlement amounts. The Company
agrees that it would not be just and equitable if contribution pursuant to this
Section 3
were determined by pro rata allocation or any other method of allocation which does not take
account of the foregoing equitable considerations.
4.
Indemnification for Expenses of a Witness
. Notwithstanding any other provision of
this Agreement, to the extent that Indemnitee is, by reason of his Corporate Status, a witness in
any Proceeding to which Indemnitee is not a party, he shall be indemnified against all Expenses
actually and reasonably incurred by him or on his behalf in connection therewith.
5.
Advancement of Expenses
. Notwithstanding any other provision of this Agreement, to
the extent allowed by applicable law, the Company shall advance all reasonable Expenses incurred by
or on behalf of Indemnitee in connection with any Proceeding by reason of Indemnitees Corporate
Status within twenty (20) days after the receipt by the Company of a statement or statements from
Indemnitee requesting such advance or advances from time to time, whether prior to or after final
disposition of such Proceeding. Such statement or statements (i) shall reasonably evidence the
Expenses incurred by Indemnitee, (ii) shall include or be accompanied by such documentation and
information as is reasonably requested by the Company to determine the nature of the Proceeding and
whether Indemnitee is entitled to the advancement of Expenses, and (iii) shall include or be
preceded by an undertaking by or on behalf of Indemnitee to repay any Expenses advanced if it shall
ultimately be determined that Indemnitee is not entitled to be indemnified against such Expenses.
Any advances and undertakings to repay pursuant to this
Section 5
shall be unsecured and
interest free. Notwithstanding the foregoing, the obligation of the Company to advance Expenses
pursuant to this
Section 5
shall be subject to the condition that, if, when
3
and to the extent that the Company determines that Indemnitee would not be permitted to be
indemnified under applicable law, the Company shall be entitled to be reimbursed, within sixty (60)
days of such determination, by Indemnitee (who hereby agrees to reimburse the Company) for all such
amounts theretofore paid;
provided, however
, that if Indemnitee has commenced or thereafter
commences legal proceedings in a court of competent jurisdiction to secure a determination that
Indemnitee should be indemnified under applicable law, any determination made by the Company that
Indemnitee would not be permitted to be indemnified under applicable law shall not be binding and
Indemnitee shall not be required to reimburse the Company for any advance of Expenses until a final
judicial determination is made with respect thereto (as to which all rights of appeal therefrom
have been exhausted or lapsed).
6.
Procedure for Determination of Entitlement to Indemnification
.
(a) To obtain indemnification under this Agreement, Indemnitee shall submit to the Company a
written request, including therein or therewith such documentation and information as is reasonably
available to Indemnitee and is reasonably necessary to determine whether and to what extent
Indemnitee is entitled to indemnification. The Chief Executive Officer of the Company shall,
promptly upon receipt of such a request for indemnification, advise the Board of Directors in
writing that Indemnitee has requested indemnification;
provided that
, if the Chief Executive
Officer is making such request, then the notice to the Board of Directors shall be given by the
Secretary of the Company.
(b) Upon written request by Indemnitee for indemnification, a determination with respect to
Indemnitees entitlement thereto shall be made by the following person or persons who shall be
empowered to make such determination: (i) the Board of Directors by a majority vote of a quorum of
Disinterested Directors (
as defined in
Section 15
); (ii) by Independent Counsel (
as defined
in
Section 15
) in a written opinion to the Board of Directors (a copy of which shall be
delivered to Indemnitee) if a quorum of the Board of Directors consisting of Disinterested
Directors is not obtainable or, even if obtainable, said Disinterested Directors so direct; or
(iii) if so directed by said Disinterested Directors, by the stockholders of the Company. If it is
determined that Indemnitee is entitled to indemnification, payment to Indemnitee shall be made
within fifteen (15) days after such determination. Indemnitee shall cooperate with the person,
persons or entity making such determination with respect to Indemnitees entitlement to
indemnification, including providing to such person, persons or entity upon reasonable advance
request any documentation or information which is not privileged or otherwise protected from
disclosure and which is reasonably available to Indemnitee and reasonably necessary to such
determination. Any Independent Counsel, member of the Board of Directors, or stockholder of the
Company shall act reasonably and in good faith in making a determination under this Agreement of
the Indemnitees entitlement to indemnification. Any Expenses incurred by Indemnitee in so
cooperating with the person, persons or entity making such determination shall be borne by the
Company to the extent allowed by applicable law (irrespective of the determination as to
Indemnitees entitlement to indemnification) and the Company hereby indemnifies and agrees to hold
Indemnitee harmless therefrom.
(c) If the determination of entitlement to indemnification is to be made by Independent
Counsel pursuant to
Section 6(b)
hereof, the Independent Counsel shall be selected as
provided in this
Section 6(c)
. The Independent Counsel shall be selected by the Board of
Directors (subject to this
Section 6(c)
), and the Company shall give written notice to
Indemnitee advising him of the identity of the Independent Counsel so selected. Indemnitee may,
within seven (7) days after receipt of such written notice of selection, deliver to the Company a
written objection to such selection;
provided, however,
such objection may be asserted only on the
ground that the Independent Counsel so selected does not meet the requirements of Independent
Counsel, as defined in
Section 15
of this Agreement, and the objection shall set forth
with particularity the factual basis of such assertion. Absent a proper and timely objection, the
person so selected shall act as Independent Counsel. If a written objection is made and
substantiated, the Independent Counsel selected may not serve as Independent Counsel unless and
until such objection is withdrawn or a court has determined that such objection is without merit.
If,
4
within twenty (20) days after submission by Indemnitee of a written request for
indemnification pursuant to
Section 6(a)
hereof, (i) an Independent Counsel has not been
selected or (ii) an Independent Counsel has been selected, but there is an outstanding written
objection regarding the independence of the Independent Counsel selected by the Company, either the
Indemnitee or the Company may petition a court of competent jurisdiction for resolution of any
objection which shall have been made by Indemnitee to the Companys selection of Independent
Counsel and/or for the appointment as Independent Counsel of a person selected by the court or by
such other person as the court shall designate, and the person with respect to whom all objections
are so resolved or the person so appointed shall act as Independent Counsel under
Section
6(b)
hereof. The Company shall pay any and all reasonable fees and expenses of Independent
Counsel incurred by such Independent Counsel in connection with acting pursuant to
Section
6(b)
hereof, and the Company shall pay all reasonable fees and expenses incident to the
procedures of this
Section 6(c)
, regardless of the manner in which such Independent Counsel
was selected or appointed. Upon the due commencement of any judicial proceeding or arbitration
pursuant to
Section 8(a)
of this Agreement, Independent Counsel shall be discharged and
relieved of any further responsibility in such capacity (subject to the applicable standards of
professional conduct then prevailing).
7.
Presumptions and Effect of Certain Proceedings.
(a) In making a determination with respect to entitlement to indemnification hereunder, the
person or persons or entity making such determination shall presume that Indemnitee is entitled to
indemnification under this Agreement if Indemnitee has submitted a request for indemnification in
accordance with
Section 6(a)
of this Agreement and the Company shall have the burden of
proof to overcome that presumption in connection with the making by any person, persons or entity
of any determination contrary to that presumption.
(b) If the person, persons or entity empowered or selected under
Section 6
of this
Agreement to determine whether Indemnitee is entitled to indemnification shall not have made a
determination within sixty (60) days after receipt by the Company of the request therefor, the
requisite determination of entitlement to indemnification shall be deemed to have been made and
Indemnitee shall be entitled to such indemnification (i) absent actual and material fraud in the
request for indemnification or (ii) a prohibition of such indemnification under applicable law;
provided, however
, that such 60-day period may be extended for a reasonable time, not to exceed an
additional thirty (30) days, if the person, persons or entity making the determination with respect
to entitlement to indemnification in good faith requires such additional time for the obtaining or
evaluating documentation and/or information relating thereto; and
provided, further
, that the
foregoing provisions of this
Section 7(b)
shall not apply (i)(A) if the determination of
entitlement to indemnification is to be made by the stockholders pursuant to
Section 6(b)
of this Agreement and (B)(1) if, within fifteen (15) days after receipt by the Company of the
request for such determination, the Board of Directors or the Disinterested Directors, if
appropriate, resolve to submit such determination to the stockholders for their consideration at an
annual meeting thereof to be held within seventy five (75) days after such receipt and such
determination is made thereat or (2) a special meeting of stockholders is called within thirty (30)
days after such receipt for the purpose of making such determination, such meeting is held for such
purpose within sixty (60) days after having been so called and such determination is made thereat
or (ii) if the determination of entitlement to indemnification is to be made by Independent Counsel
pursuant to
Section 6(b)
of this Agreement.
(c) The termination of any Proceeding or of any claim, issue or matter therein, by judgment,
order, settlement (with or without court approval), conviction, or upon a plea of
no lo contendere
or its equivalent, shall not (except as otherwise expressly provided in this Agreement) of itself
adversely affect the right of Indemnitee to indemnification or create a presumption that Indemnitee
did not act in good faith and in a manner which he reasonably believed to be in or not opposed to
the best interests of the Company or, with respect to any criminal Proceeding, that Indemnitee had
reasonable cause to believe that his conduct was unlawful.
5
(d) For purposes of any determination of good faith, Indemnitee shall be deemed to have acted
in good faith if Indemnitees action is based on the records or books of account of the Enterprise
(
as defined in
Section 15
), including financial statements, or on information supplied to
Indemnitee by the directors, officers or key employees of the Enterprise in the course of their
duties, or on the advice of legal counsel for the Enterprise or on information or records given or
reports made to the Enterprise by an independent certified public accountant or by an appraiser or
other expert selected with reasonable care by the Enterprise. In addition, the knowledge and/or
actions, or failure to act, of any director, officer, agent or employee of the Enterprise shall not
be imputed to Indemnitee for purposes of determining the right to indemnification under this
Agreement. The provisions of this
Section 7(d)
shall not be deemed to be exclusive or to
limit in any way the other circumstances in which the Indemnitee may be deemed to have met the
applicable standard of conduct set forth in this Agreement.
8.
Remedies of Indemnitee
.
(a) In the event that (i) payment of contribution or indemnification is not made pursuant to
Section 3
or
Section
4 of this Agreement, respectively, within fifteen (15) days
after receipt by the Company of a written request therefor, (ii) advancement of Expenses is not
timely made pursuant to
Section 5
of this Agreement, (iii) a determination of entitlement
to indemnification shall not have been made pursuant to
Section 6(b)
of this Agreement
within the time frames described in
Section 7(b)
, (iv) a determination is made pursuant to
Section 6
of this Agreement that Indemnitee is not entitled to indemnification under this
Agreement, or (v) payment of indemnification is not made within fifteen (15) days after a
determination has been made that Indemnitee is entitled to indemnification or such determination is
deemed to have been made pursuant to
Section 6
or
Section 7
of this Agreement,
respectively, Indemnitee shall be entitled to an adjudication in an appropriate court of the State
of Delaware, or in any other court of competent jurisdiction, of his entitlement to such
indemnification. Alternatively, Indemnitee, at his option, may seek an award in arbitration to be
conducted by a single arbitrator pursuant to the Commercial Arbitration Rules of the American
Arbitration Association. Indemnitee shall commence such proceeding seeking an adjudication or an
award in arbitration within 180 days following the date on which Indemnitee first has the right to
commence such proceeding pursuant to this
Section 8(a)
. The Company shall not oppose
Indemnitees right to seek any such adjudication or award in arbitration.
(b) In the event that a determination shall have been made pursuant to
Section 6(b)
of
this Agreement that Indemnitee is not entitled to indemnification, any judicial proceeding or
arbitration commenced pursuant to this
Section 8
shall be conducted in all respects as a
de
novo
trial, or arbitration, on the merits and Indemnitee shall not be prejudiced by reason of that
adverse determination.
(c) If a determination shall have been made pursuant to
Section 6(b)
of this Agreement
that Indemnitee is entitled to indemnification, the Company shall be bound by such determination in
any judicial proceeding or arbitration commenced pursuant to this
Section 8
, absent (i) a
misstatement by Indemnitee of a material fact, or an omission of a material fact necessary to make
Indemnitees statement not materially misleading, in connection with the request for
indemnification, or (ii) a prohibition of such indemnification under applicable law.
(d) In the event that Indemnitee, pursuant to this
Section 8
, seeks a judicial
adjudication of or an award in arbitration to enforce his rights under, or to recover damages for
breach of, this Agreement, Indemnitee shall be entitled to recover from the Company, and shall be
indemnified by the Company against, any and all Expenses actually and reasonably incurred by him in
such judicial adjudication or arbitration, but only if he prevails therein. If it shall be
determined in said judicial adjudication or arbitration that Indemnitee is entitled to receive part
but not all of the indemnification sought, the expenses incurred by Indemnitee in connection with
such judicial adjudication or arbitration shall be appropriately prorated. The Company shall
indemnify Indemnitee against any and all expenses
6
and, if requested by Indemnitee, shall (within ten (10) days after receipt by the Company of a
written request therefor) advance such expenses to Indemnitee, which are incurred by Indemnitee in
connection with any action brought by Indemnitee to recover under any directors and officers
liability insurance policies maintained by the Company, regardless of whether Indemnitee ultimately
is determined to be entitled to such indemnification, advancement of expenses or insurance
recovery, as the case may be.
(e) The Company shall be precluded from asserting in any judicial proceeding or arbitration
commenced pursuant to this
Section 8
that the procedures and presumptions of this Agreement
are not valid, binding and enforceable and shall stipulate in any such court or before any such
arbitrator that the Company is bound by all the provisions of this Agreement.
9.
Non-Exclusivity; Survival of Rights; Insurance; Subrogation
.
(a) The rights of indemnification as provided by this Agreement shall not be deemed exclusive
of any other rights to which Indemnitee may at any time be entitled under applicable law, the
bylaws or certificate of incorporation of the Company, any agreement, a vote of stockholders or a
resolution of directors, or otherwise. No amendment, alteration or repeal of this Agreement or of
any provision hereof shall limit or restrict any right of Indemnitee under this Agreement in
respect of any action taken or omitted by such Indemnitee in his Corporate Status prior to such
amendment, alteration or repeal. To the extent that a change in applicable law, whether by statute
or judicial decision, permits greater indemnification than would be afforded currently under the
Companys bylaws and this Agreement, it is the intent of the parties hereto that Indemnitee shall
enjoy by this Agreement the greater benefits so afforded by such change. No right or remedy herein
conferred is intended to be exclusive of any other right or remedy, and every other right and
remedy shall be cumulative and in addition to every other right and remedy given hereunder or now
or hereafter existing at law or in equity or otherwise. The assertion or employment of any right
or remedy hereunder, or otherwise, shall not prevent the concurrent assertion or employment of any
other right or remedy.
(b) To the extent that the Company maintains an insurance policy or policies providing
liability insurance for directors, officers, employees, or agents or fiduciaries of the Company or
of any other corporation, partnership, joint venture, trust, employee benefit plan or other
enterprise which such person serves at the request of the Company, Indemnitee shall be covered by
such policy or policies in accordance with its or their terms to the maximum extent of the coverage
available for any such director, officer, employee or agent under such policy or policies.
(c) In the event of any payment under this Agreement, the Company shall be subrogated to the
extent of such payment to all of the rights of recovery of Indemnitee, who shall execute all papers
required and take all action necessary to secure such rights, including execution of such documents
as are necessary to enable the Company to bring suit to enforce such rights.
(d) The Company shall not be liable under this Agreement to make any payment of amounts
otherwise indemnifiable hereunder if and to the extent that Indemnitee has otherwise actually
received such payment under any insurance policy, contract, agreement or otherwise.
10.
Exception to Right of Indemnification
. Notwithstanding any other provision of
this Agreement, Indemnitee shall not be entitled to indemnification under this Agreement with
respect to any Proceeding or claim therein brought voluntarily by Indemnitee and not by way of
defense, unless (a) the bringing of such Proceeding or making of such claim shall have been
approved by the Board of Directors or (b) such Proceeding is being brought by the Indemnitee to
assert his rights under this Agreement.
7
11.
Notification and Defense of Claim
. Indemnitee agrees promptly to notify the
Company in writing upon being served with any summons, citation, subpoena, complaints, indictment,
information or other document relating to any Proceeding or matter which may be subject to indemnification
covered hereunder. The failure to so notify the Company shall not relieve the Company of any
obligation which it may have to the Indemnitee under this Agreement or otherwise. Notwithstanding
any other provision of this Agreement, with respect to any such Proceeding of which Indemnitee
notifies the Company:
(a) The Company will be entitled to participate therein at its own expense;
(b) Except as otherwise provided in this
Section 11(b)
, to the extent that it may
wish, the Company, together with any other indemnifying party similarly notified, shall be entitled
to assume the defense thereof, with counsel reasonably satisfactory to Indemnitee. After notice
from the Company to Indemnitee of its election so to assume the defense thereof, the Company shall
not be liable to Indemnitee under this Agreement for any Expenses subsequently incurred by
Indemnitee in connection with the defense thereof except as otherwise provided below. Indemnitee
shall have the right to employ Indemnitees own counsel in such Proceeding, but the fees and
expenses of such counsel incurred after notice from the Company of its assumption of the defense
thereof shall be at the expense of Indemnitee unless (i) the employment of counsel by Indemnitee
has been authorized by the Company, (ii) Indemnitee shall have reasonably concluded that there may
be a conflict of interest between the Company and Indemnitee in the conduct of the defense of such
action or (iii) the Company shall not in fact have employed counsel to assume the defense of the
action, in each of which cases the fees and expenses of Indemnitees counsel shall be at the
expense of the Company. The Company shall not be entitled to assume the defense of any Proceeding
brought by or on behalf of the Company or as to which Indemnitee shall have made the conclusion
provided for in (ii) above; and
(c) The Company shall not be liable to indemnify Indemnitee under this Agreement for any
amounts paid in settlement of any Proceeding effected without the Companys written consent. The
Company shall not settle any Proceeding in any manner that would impose any penalty or limitation
on or disclosure obligation with respect to Indemnitee without Indemnitees written consent.
Neither the Company nor Indemnitee will unreasonably withhold its consent to any proposed
settlement.
12.
Duration of Agreement
. All agreements and obligations of the Company contained
herein shall continue during the period Indemnitee is an officer or director of the Company (or is
or was serving at the request of the Company as a director, officer, employee or agent of another
corporation, partnership, joint venture, trust or other enterprise) and shall continue thereafter
so long as Indemnitee shall be subject to any Proceeding (or any proceeding commenced under
Section 8
hereof) by reason of his Corporate Status, whether or not he is acting or serving
in any such capacity at the time any liability or expense is incurred for which indemnification can
be provided under this Agreement. This Agreement shall be binding upon and inure to the benefit of
and be enforceable by the parties hereto and their respective successors (including any direct or
indirect successor by purchase, merger, consolidation or otherwise to all or substantially all of
the business or assets of the Company), assigns, spouses, heirs, executors and personal and legal
representatives. This Agreement shall continue in effect regardless of whether Indemnitee
continues to serve as an officer or director of the Company or any other Enterprise at the
Companys request.
13.
Security
. To the extent requested by the Indemnitee and approved by the Board of
Directors, the Company may at any time and from time to time provide security to the Indemnitee for
the Companys obligations hereunder through an irrevocable blank line of credit, funded trust or
other collateral. Any such security, once provided to the Indemnitee, may not be revoked or
released without the prior written consent of the Indemnitee.
8
14.
Enforcement
.
(a) The Company expressly confirms and agrees that it has entered into this Agreement and
assumed the obligations imposed on it hereby in order to induce Indemnitee to serve as an officer
or director of the Company, and the Company acknowledges that Indemnitee is relying upon this
Agreement in serving as an officer or director of the Company.
(b) This Agreement constitutes the entire agreement between the parties hereto with respect to
the subject matter hereof and supersedes all prior agreements and understandings, oral written and
implied, between the parties hereto with respect to the subject matter hereof.
15.
Definitions
. For purposes of this Agreement:
(a)
Corporate Status
describes the status of a person who is or was a director, officer,
employee or agent or fiduciary of the Company or of any other corporation, partnership joint
venture, trust, employee benefit plan or other Enterprise which such person is or was serving at
the express written request of the Company.
(b)
Disinterested Director
means a director of the Company who is not and was not a party to
the Proceeding with respect to which indemnification is sought by Indemnitee.
(c)
Enterprise
shall mean the Company and any other corporation, partnership, joint venture,
trust, employee benefit plan or other enterprise of which Indemnitee is or was serving at the
express written request of the Company as a director, officer, employee, agent or fiduciary.
(d)
Expenses
shall include all reasonable attorneys fees, retainers, court costs,
transcript costs, fees of experts, witness fees, travel expenses, duplicating costs, printing and
binding costs, telephone charges, postage, delivery service fees, and all other disbursements or
expenses of the types customarily incurred in connection with prosecuting, defending, preparing to
prosecute or defend, investigating, participating, or being or preparing to be a witness in, or
otherwise participating in a Proceeding.
(e)
Independent Counsel
means a law firm, or a member of a law firm, that is experienced in
matters of corporation law and neither presently is, nor in the past five years has been, retained
to represent: (i) the Company or Indemnitee in any matter material to either such party (other
than with respect to matters concerning the Indemnitee under this Agreement, or of other
indemnitees under similar indemnification agreements) or (ii) any other party to the Proceeding
giving rise to a claim for indemnification hereunder. The term Independent Counsel shall not
include any person who, under the applicable standards of professional conduct then prevailing,
would have a conflict of interest in representing either the Company or Indemnitee in an action to
determine Indemnitees rights under this Agreement.
(f)
Proceeding
includes any threatened, pending or completed action, suit, arbitration,
alternate dispute resolution mechanism, investigation, inquiry, administrative hearing or any other
actual, threatened or completed proceeding, whether brought by or in the right of the Company or
otherwise and whether civil, criminal, administrative or investigative, in which Indemnitee was, is
or will be involved as a party or otherwise, by reason of the fact that Indemnitee is or was a
director, officer employee or agent of the Company, by reason of any action taken by him or of any
inaction on his part while acting as a director, officer employee or agent of the Company, or by
reason of the fact that he is or was serving at the request of the Company as a director, officer,
employee or agent of another corporation, partnership, joint venture, trust or other enterprise; in
each case whether or not he is acting or serving in any such capacity at the time any liability or
expense is incurred for which indemnification can be provided under this Agreement; including one
pending on or before the date of this Agreement; and excluding one initiated by an Indemnitee pursuant to
Section 8
of this Agreement to
enforce his rights under this Agreement.
9
16.
Severability
. If any provision or provisions of this Agreement shall be held by a
court of competent jurisdiction to be invalid, void, illegal or otherwise unenforceable for any
reason whatsoever: (a) the validity, legality and enforceability of the remaining provisions of
this Agreement (including without limitation, each portion of any section of this Agreement
containing any such provision held to be invalid, illegal or unenforceable, that is not itself
invalid, illegal or unenforceable) shall not in any way be affected or impaired thereby and shall
remain enforceable to the fullest extent permitted by law; and (b) to the fullest extent possible,
the provisions of this Agreement (including, without limitation, each portion of any section of
this Agreement containing any such provision held to be invalid, illegal or unenforceable, that is
not itself invalid, illegal or unenforceable) shall be construed so as to give effect to the intent
manifested thereby.
17.
Modification and Waiver
. No supplement, modification, termination or amendment of
this Agreement shall be binding unless executed in writing by both of the parties hereto. No
waiver of any of the provisions of this Agreement shall be deemed or shall constitute a waiver of
any other provisions hereof (whether or not similar) nor shall such waiver constitute a continuing
waiver.
18.
Notices
. All notices, requests, demands and other communications hereunder shall
be in writing and shall be deemed to have been duly given if (i) delivered by hand and receipted
for by the party to whom said notice or other communication shall have been directed, or (ii)
mailed by certified or registered mail with postage prepaid, on the third business day after the
date postmarked. Addresses for notice to either party are as provided below, or as subsequently
modified by written notice
(a) If to Indemnitee, to:
(b) If to the Company, to:
La Jolla Pharmaceutical Corporation
Attention: Corporate Secretary
6455 Nancy Ridge Drive
San Diego, California 92121
(c) With a copy to:
Mark W. Shurtleff, Esq.
Gibson, Dunn & Crutcher LLP
4 Park Plaza, Suite 1700
Irvine, California 92614
19.
Counterparts
. This Agreement may be executed in one or more counterparts, each of
which shall for all purposes be deemed to be an original but all of which together shall constitute
one and the same Agreement. Signatures transmitted electronically or by facsimile will be deemed
original signatures.
20.
Headings; References; Pronouns
. The headings of the paragraphs of this Agreement
are inserted for convenience only and shall not be deemed to constitute part of this Agreement or
to affect the construction thereof. References herein to section numbers are to sections of this
Agreement. All pronouns and any variations thereof shall be deemed to refer to the masculine, feminine,
neuter, singular or plural as appropriate.
21.
Consent to Jurisdiction
. The Company and Indemnitee each hereby irrevocably
consent to the jurisdiction of the courts of the State of Delaware for all purposes in connection
with any action or proceeding which arises out of or relates to this Agreement and agree that any
action instituted under this Agreement shall be brought only in the state courts of the State of
Delaware.
22.
Governing Law
. The parties agree that this Agreement shall be governed by, and
construed and enforced in accordance with, the laws of the State of Delaware without application of
the conflict of laws principles thereof.
10
IN WITNESS WHEREOF, the parties hereto have executed this Agreement on and as of the day and
year first above written.
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LA JOLLA PHARMACEUTICAL COMPANY
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By:
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Steven B. Engle
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Chairman and Chief Executive Officer
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INDEMNITEE
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Signature:
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Print Name:
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