e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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þ |
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2006
OR
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o |
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the transition period from to
Commission file number: 0-24274
LA JOLLA PHARMACEUTICAL COMPANY
(Exact name of registrant as specified in its charter)
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Delaware
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33-0361285 |
(State or other jurisdiction of
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(I.R.S. Employer |
incorporation or organization)
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Identification No.) |
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6455 Nancy Ridge Drive |
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92121 |
San Diego, CA
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(Zip Code) |
(Address of principal executive offices)
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Registrants telephone number, including area code: (858) 452-6600
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act).
Yes o No þ
The number of shares of the registrants common stock, $0.01 par value per share, outstanding at
November 1, 2006 was 32,670,043.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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September 30, |
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December 31, |
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2006 |
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2005 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
7,086 |
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$ |
6,411 |
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Short-term investments |
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43,070 |
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66,466 |
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Other current assets |
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1,080 |
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903 |
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Total current assets |
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51,236 |
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73,780 |
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Property and equipment, net |
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2,794 |
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4,037 |
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Patent costs and other assets, net |
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3,353 |
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3,111 |
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Total assets |
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$ |
57,383 |
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$ |
80,928 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,615 |
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$ |
866 |
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Accrued clinical/regulatory expenses |
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787 |
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227 |
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Accrued expenses |
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1,433 |
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1,284 |
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Accrued payroll and related expenses |
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580 |
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778 |
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Accrued severance expenses |
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35 |
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Current portion of obligations under notes payable |
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181 |
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501 |
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Total current liabilities |
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4,631 |
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3,656 |
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Noncurrent portion of obligations under notes payable |
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11 |
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142 |
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Commitments |
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Stockholders equity: |
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Common stock |
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326 |
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325 |
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Additional paid-in capital |
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341,478 |
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337,117 |
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Accumulated deficit |
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(289,063 |
) |
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(260,312 |
) |
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Total stockholders equity |
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52,741 |
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77,130 |
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Total liabilities and stockholders equity |
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$ |
57,383 |
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$ |
80,928 |
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Note: The condensed consolidated balance sheet at December 31, 2005 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 US generally accepted accounting principles.
See accompanying notes.
1
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2006 |
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2005 |
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2006 |
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2005 |
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Expenses: |
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Research and development |
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$ |
7,687 |
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$ |
4,969 |
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$ |
23,764 |
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$ |
17,499 |
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General and administrative |
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1,546 |
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1,081 |
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7,171 |
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4,224 |
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Total expenses |
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9,233 |
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6,050 |
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30,935 |
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21,723 |
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Loss from operations |
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(9,233 |
) |
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(6,050 |
) |
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(30,935 |
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(21,723 |
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Interest income |
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701 |
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155 |
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2,211 |
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498 |
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Interest expense |
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(6 |
) |
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(32 |
) |
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(27 |
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(98 |
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Net loss |
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$ |
(8,538 |
) |
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$ |
(5,927 |
) |
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$ |
(28,751 |
) |
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$ |
(21,323 |
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Basic and diluted net loss per share |
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$ |
(0.26 |
) |
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$ |
(0.40 |
) |
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$ |
(0.88 |
) |
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$ |
(1.47 |
) |
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Shares used in computing basic and
diluted net loss per share |
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32,534 |
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14,808 |
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32,510 |
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14,493 |
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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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2006 |
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2005 |
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Operating activities: |
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Net loss |
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$ |
(28,751 |
) |
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$ |
(21,323 |
) |
Adjustments to reconcile net loss to net cash used for operating
activities: |
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Depreciation and amortization |
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1,507 |
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1,593 |
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Loss on write-off/disposal of property and equipment, patents and
other assets |
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172 |
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371 |
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Share-based compensation expense |
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4,170 |
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6 |
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Accretion of interest income, net |
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46 |
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(27 |
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Change in operating assets and liabilities: |
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Other current assets |
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(177 |
) |
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7 |
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Accounts payable and accrued expenses |
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898 |
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(1,657 |
) |
Accrued clinical/regulatory expenses |
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560 |
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(387 |
) |
Accrued payroll and related expenses |
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(198 |
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(609 |
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Accrued severance expenses |
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35 |
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Net cash used for operating activities |
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(21,738 |
) |
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(22,026 |
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Investing activities: |
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Purchases of short-term investments |
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(16,700 |
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(23,800 |
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Sales of short-term investments |
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40,050 |
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30,236 |
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Additions to property and equipment |
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(316 |
) |
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(122 |
) |
Increase in patent costs and other assets |
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(362 |
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(288 |
) |
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Net cash provided by investing activities |
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22,672 |
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6,026 |
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Financing activities: |
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Net proceeds from issuance of common stock |
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192 |
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15,789 |
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Payments on obligations under capital leases |
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(14 |
) |
Payments on obligations under notes payable |
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(451 |
) |
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(764 |
) |
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Net cash (used for) provided by financing activities |
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(259 |
) |
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15,011 |
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Net increase (decrease) in cash and cash equivalents |
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675 |
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(989 |
) |
Cash and cash equivalents at beginning of period |
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6,411 |
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2,861 |
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Cash and cash equivalents at end of period |
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$ |
7,086 |
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$ |
1,872 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
27 |
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$ |
98 |
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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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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2006
1. Basis of Presentation
The accompanying Unaudited Condensed Consolidated Financial Statements of La Jolla Pharmaceutical
Company and its wholly-owned subsidiary (the Company) have been prepared in accordance with US
generally accepted accounting principles (GAAP) for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all
of the information and disclosures required by U.S. GAAP for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring accruals, the severance
accrual see Note 3 for further details and the restructuring accrual see Note 4 for further
details) considered necessary for a fair presentation have been included. Operating results for
the three and nine months ended September 30, 2006 are not necessarily indicative of the results
that may be expected for other quarters or the year ended December 31, 2006. 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, 2005 included in the Companys Form 10-K filed with the Securities and Exchange
Commission.
2. Accounting Policies
Principles of Consolidation
The accompanying Unaudited Condensed Consolidated Financial Statements include the accounts of La
Jolla Pharmaceutical Company and its wholly owned subsidiary, La Jolla Limited, which was
incorporated in England in 2004. There have been no significant transactions related to La Jolla
Limited since its inception.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to
make estimates and assumptions that affect the amounts reported in the 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.
New Accounting Standards
In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No. 108
(SAB 108). SAB 108 addresses the process and diversity in practice of quantifying financial
statement misstatements resulting in the potential build up of improper amounts on the balance
sheet. SAB 108 is effective for interim periods of the first fiscal year ending after November 15,
2006. The Company currently does not believe that the adoption of SAB 108 will have a material
impact on its Consolidated Financial Statements.
In September 2006, the Financial Accounting Standards Board (FASB) issued Statement of Financial
Accounting Standard (SFAS) No. 157, Fair Value Measurements (SFAS 157). SFAS 157 establishes a
framework for measuring fair value and expands disclosures about fair value measurements. The
changes to current practice resulting from the application of SFAS 157 relate to the definition of
fair value, the methods used to measure fair value, and the expanded disclosures about fair value
measurements. SFAS 157 is effective for fiscal years beginning after November 15, 2007 and interim
periods within those fiscal years. The Company currently does not believe that the adoption of
SFAS 157 will have a material impact on its Consolidated Financial Statements.
4
In June 2006, FASB issued Interpretation No. 48, Accounting for Uncertainty in Income Taxes (FIN
48), which clarifies the accounting for uncertainty in income taxes recognized in the financial
statements in accordance with FASB Statement No. 109, Accounting for Income Taxes. FIN 48 provides
guidance on the financial statement recognition and measurement of a tax position taken or expected
to be taken in a tax return. FIN 48 also provides guidance on derecognition, classification,
interest and penalties, accounting in interim periods, disclosures, and transition. FIN 48 is
effective for fiscal years beginning after December 15, 2006. The Company is currently evaluating
the impact of this standard on its Consolidated Financial Statements.
On January 1, 2006, the Company adopted SFAS No. 154, Accounting Changes and Error Correctionsa
replacement of APB Opinion No. 20 and FASB Statement No. 3 (SFAS 154). SFAS 154 changed the
requirements for the accounting for and reporting of a change in accounting principle. SFAS 154
applies to all voluntary changes in accounting principles and changes required by an accounting
pronouncement in the unusual instance that the pronouncement does not include specific transition
methods. The adoption of SFAS 154 did not affect the Companys Condensed Consolidated Financial
Statements as of and for the three and nine months ended September 30, 2006. Its effects on future
periods will depend on the nature and significance of any future accounting changes subject to SFAS
154.
Share-Based Compensation
On January 1, 2006, the Company adopted SFAS No. 123R, Share-Based Payment (SFAS 123R), which is
a revision of SFAS No. 123, Accounting and Disclosure of Stock-Based Compensation (SFAS 123).
SFAS 123R requires the measurement and recognition of compensation expense for all share-based
payment awards made to employees and directors, including stock options, restricted stock and
purchases under the La Jolla Pharmaceutical Company 1995 Employee Stock Purchase Plan (the ESPP),
based on estimated fair values. SFAS 123R supersedes the Companys previous accounting under
Accounting Principles Board Opinion (APB) No. 25, Accounting for Stock Issued to Employees (APB
25), and SFAS 123, for periods beginning in fiscal 2006. In March 2005, the Securities and
Exchange Commission issued Staff Accounting Bulletin No. 107 (SAB 107) relating to SFAS 123R. The
Company has applied the provisions of SAB 107 in its adoption of SFAS 123R.
The Company adopted SFAS 123R using the modified prospective transition method, which requires the
application of the accounting standard as of January 1, 2006, the first day of the Companys fiscal
year 2006. The Companys Condensed Consolidated Statements of Operations as of and for the three
and nine months ended September 30, 2006 reflect the impact of SFAS 123R. In accordance with the
modified prospective transition method, the Companys Condensed Consolidated Statements of
Operations for prior periods have not been restated to reflect, and do not include, the impact of
SFAS 123R. Share-based compensation expense recognized under SFAS 123R for the three and nine
months ended September 30, 2006 was $1,142,000 and $4,168,000, respectively. As of September 30,
2006, there was $9,244,000 of total unrecognized compensation cost related to non-vested
share-based payment awards granted under all equity compensation plans. Total unrecognized
compensation cost will be adjusted for future changes in estimated forfeitures. The Company expects
to recognize that cost over a weighted-average period of 1.3 years.
Prior to January 1, 2006, the Company had adopted the disclosure-only provision of SFAS 123.
Accordingly, the Company had not previously recognized compensation expense, except for
compensation expense related to stock options granted to consultants and restricted stock granted
to certain members of management.
Options or stock awards issued to non-employees, other than non-employee directors, have been
determined in accordance with Emerging Issues Task Force 96-18, Accounting for Equity Instruments
That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services. Deferred charges for options granted to such non-employees are periodically remeasured
as the options vest. In January 2006 and January 2005, the Company granted a non-qualified stock
option to purchase 1,000 shares of common stock to a consultant at an exercise price equal to the
fair market value of the stock at the date of each grant. The Company recognized compensation
expense for these
5
stock option grants of approximately $1,000 and $3,000 for the three-month periods ended September
30, 2006 and 2005, respectively, and $3,000 and $6,000 for the nine-month periods ended September
30, 2006 and 2005, respectively.
On December 14, 2005, the Company issued 83,518 shares of restricted stock to certain members of
management in exchange for services provided over the vesting period, pursuant to certain retention
agreements dated October 6, 2005. The shares of restricted stock fully vest (i.e., the
restrictions lapse) one year from the date of grant and are subject to repurchase by the Company
until the one-year anniversary of the date of issuance. Pursuant to a separation agreement dated
March 17, 2006, the Companys repurchase right with respect to 29,120 shares of restricted stock
granted to the former Chairman and Chief Executive Officer immediately lapsed upon his resignation
on March 14, 2006. As such and in accordance with his retention agreement, the Company
accelerated the vesting of these shares of restricted stock.
On March 15, 2006, the Company issued 20,000 shares of restricted stock to the new Chairman of the
Board in exchange for services provided over the vesting period. The shares of restricted stock
vest with respect to 10,000 shares six months after the issuance date and with respect to the
remaining 10,000 shares upon the first anniversary of the issuance date. The shares of restricted
stock are subject to repurchase by the Company until the vesting provisions have been met.
In accordance with SFAS 123R, the Company recognized approximately $97,000 and $318,000 in
compensation expense for the restricted stock grants noted above for the three and nine months
ended September 30, 2006, respectively, which includes compensation expense for the acceleration of
vesting.
The table below reflects net loss (in thousands) and basic and diluted net loss per share for the
three and nine months ended September 30, 2005 assuming the Company determined compensation expense
in accordance with SFAS 123:
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Three Months Ended |
|
Nine Months Ended |
|
|
September 30, 2005 |
|
September 30, 2005 |
|
|
|
Net lossas reported |
|
$ |
(5,927 |
) |
|
$ |
(21,323 |
) |
Net losspro forma |
|
$ |
(6,686 |
) |
|
$ |
(24,311 |
) |
|
|
|
Basic and diluted net loss per shareas reported |
|
$ |
(0.40 |
) |
|
$ |
(1.47 |
) |
Basic and diluted net loss per sharepro forma |
|
$ |
(0.45 |
) |
|
$ |
(1.68 |
) |
|
|
|
The assumptions used to calculate share-based compensation expense for 2005 are discussed below.
SFAS 123R requires companies to estimate the fair value of share-based payment awards on the date
of grant using an option-pricing model. The value of the portion of the award that is ultimately
expected to vest is recognized as expense over the requisite service periods as share-based
compensation expense in the Companys Condensed Consolidated Statements of Operations. For the
three and nine months ended September 30, 2006, the Companys Condensed Consolidated Statements of
Operations included compensation expense for share-based payment awards granted prior to, but not
yet vested as of, December 31, 2005 based on the grant date fair value estimated in accordance with
the pro forma provisions of SFAS 123 and compensation expense for the share-based payment awards
granted subsequent to December 31, 2005 based on the grant date fair value estimated in accordance
with the provisions of SFAS 123R. Compensation expense for all share-based payment awards granted
prior to the adoption of SFAS 123R will continue to be recognized using the straight-line
single-option method of attributing the value of share-based compensation to expense. Compensation
expense for all share-based payment awards granted after December 31, 2005 is recognized using the
straight-line single-option method. As share-based compensation expense recognized in the Condensed
Consolidated Statements of Operations for the first nine months of fiscal 2006 is based on awards
ultimately expected to vest, share-based compensation expense has been reduced for estimated
forfeitures. SFAS 123R requires forfeitures to be estimated at the time of grant and revised, if
necessary, in subsequent periods if actual forfeitures differ from those estimates. In the
Companys pro forma information required under SFAS 123 for the periods prior to fiscal 2006, the
Company accounted for forfeitures as they occurred.
6
As permitted by SFAS 123R, the Company utilizes the Black-Scholes option-pricing model as its
method
of valuation for stock options and purchases under the ESPP. The Black-Scholes model was previously
utilized for the Companys pro forma information required under SFAS 123. The Companys
determination of the fair value of share-based payment awards on the date of grant using an
option-pricing model is affected by the Companys stock price as well as assumptions regarding a
number of highly complex and subjective variables. These variables include, but are not limited to,
the Companys expected stock price volatility over the term of the awards and actual and projected
employee stock option exercise behaviors. Option-pricing models were developed for use in
estimating the value of traded options that have no vesting or hedging restrictions and are fully
transferable. Because the employee and director stock options granted by the Company have
characteristics that are significantly different from traded options, and because changes in the
subjective assumptions can materially affect the estimated value, in managements opinion the
existing valuation models may not provide an accurate measure of the fair value of the employee and
director stock options granted by the Company. Although the fair value of the employee and director
stock options granted by the Company is determined in accordance with SFAS 123R using an
option-pricing model, that value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
Valuation and Expense Information Under SFAS 123R and APB 25
The following table summarizes share-based compensation expense (in thousands) related to employee
and director stock options, restricted stock and ESPP purchases under SFAS 123R for the three and
nine months ended September 30, 2006:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, 2006 |
|
|
September 30, 2006 |
|
Research and development |
|
$ |
446 |
|
|
$ |
1,590 |
|
General and administrative |
|
|
696 |
|
|
|
2,578 |
|
|
|
|
|
|
|
|
Share-based compensation
expense included in
operating expenses |
|
$ |
1,142 |
|
|
$ |
4,168 |
|
|
|
|
|
|
|
|
For the nine months ended September 30, 2006 and 2005, the Company estimated the fair value of each
option grant and ESPP purchase right on the date of grant using the Black-Scholes option-pricing
model with the following weighted-average assumptions:
Options:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.9 |
% |
|
|
3.8 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
113.9 |
% |
|
|
152.5 |
% |
Expected life (years) |
|
|
5.9 |
|
|
|
5.9 |
|
ESPP:
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
2006 |
|
2005 |
Risk-free interest rate |
|
|
4.8 |
% |
|
|
4.0 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
46.0 |
% |
|
|
132.3 |
% |
Expected life (years) |
|
3 months |
|
|
5.9 |
|
The weighted-average fair values of options granted were $3.66 and $3.95 for the three-month
periods ended September 30, 2006 and 2005, respectively, and $4.64 and $2.33 for the nine-month
periods ended September 30, 2006 and 2005, respectively. The weighted-average purchase prices of
shares purchased through the ESPP were $3.07 and $3.06 for the three-month periods and $3.07 and
$3.03 for the nine-month periods ended September 30, 2006 and 2005, respectively.
The risk-free interest rate assumption is based on observed interest rates appropriate for the term
of the Companys employee and director stock options and ESPP purchases. The dividend yield
assumption is based on the Companys history and expectation of dividend payouts.
7
The Company used historical stock price volatility as the expected volatility assumption required
in the Black-Scholes option-pricing model consistent with SFAS 123R. Prior to fiscal 2006, the
Company used its historical stock price volatility in accordance with SFAS 123 for purposes of its
pro forma information. The selection of the historical volatility approach was based on the
availability of historical stock prices for the duration of the awards expected term and the
Companys assessment that historical volatility is more representative of future stock price trends
than other available methods. The volatility for option grants made during the three and nine
months ended September 30, 2006 was 111.0% and 113.9%, respectively. The volatility for stock
purchased through the ESPP during the three and nine months ended September 30, 2006 was 30.9% and
46.0%, respectively.
The expected life of employee and director stock options represents the weighted-average period the
stock options are expected to remain outstanding. Under the SAB 107 simplified method, the
expected life calculated by the Company for option grants made during the nine months ended
September 30, 2006 was 5.8 years for the new and existing employee grants, 6.1 years for the new
officer grants, and 5.5 6.0 years for the director grants. The expected life for ESPP purchase
rights represents the length of each purchase period. Because employees purchase stock quarterly,
the expected term for ESPP purchase rights is three months for shares purchased during the
nine-month period ending September 30, 2006. Prior to the adoption of SFAS 123R on January 1, 2006
the Company utilized an estimate of expected life for ESPP that was consistent with its estimate
for options.
Because share-based compensation expense recognized in the Condensed Consolidated Statements of
Operations for the first nine months of fiscal 2006 is based on awards ultimately expected to vest,
it has been reduced for estimated forfeitures. SFAS 123R requires forfeitures to be estimated at
the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ
from those estimates. Forfeitures were estimated based on historical experience. In the Companys
pro forma information required under SFAS 123 for the periods prior to fiscal 2006, the Company
accounted for forfeitures as they occurred.
Reverse Stock Split
On December 12, 2005, the Companys stockholders approved a one-for-five reverse stock split. The
reverse stock split was effective as of the close of business on December 21, 2005. The effect of
the reverse stock split, for the purposes of the presentation of basic and diluted net loss per
share and shares used in computing such net loss per share, in the Condensed Consolidated
Statements of Operations and the Notes to Condensed Consolidated Financial Statements have been
applied retroactively to the three and nine months ended September 30, 2005.
Net Loss Per Share
Basic and diluted net loss per share is computed using the weighted-average number of common shares
outstanding during the periods in accordance with SFAS No. 128, Earnings per Share, and Staff
Accounting Bulletin No. 98. Basic earnings per share (EPS) is calculated by dividing the net
income or loss by the weighted-average number of common shares outstanding for the period, without
consideration for common share equivalents. Diluted EPS is computed by dividing the net income or
loss by the weighted-average number of common share equivalents outstanding for the period
determined using the treasury-stock method. For purposes of this calculation, stock options,
common stock subject to repurchase by the Company, and warrants are considered to be common stock
equivalents and are only included in the calculation of diluted EPS when their effect is dilutive.
Because the Company has incurred a net loss for all periods presented in the Condensed Consolidated
Statements of Operations, stock options, common stock subject to repurchase and warrants are not
included in the computation of net loss per share because their effect is anti-dilutive. The
shares used to compute basic and diluted net loss per share represent the weighted-average common
shares outstanding, reduced by the weighted-average unvested common shares subject to repurchase.
The number of weighted-average unvested common shares subject to repurchase for the three and nine
months ended September 30, 2006 was 64,398 and 61,724, respectively. There were no unvested common
shares subject to repurchase for the three and nine months ended September 30, 2005.
8
Comprehensive Loss
In accordance with SFAS No. 130, Reporting Comprehensive Income (Loss), unrealized gains and losses
on available-for-sale securities are included in other comprehensive income (loss). There were no
unrealized gains or losses on available-for-sale securities for the three-month and nine-month
periods ended September 30, 2006. The Companys comprehensive net loss totaled $5,927,000 for the
three-month period ended September 30, 2005 and $21,300,000 for the nine-month period ended
September 30, 2005.
3. Severance Charges
On March 17, 2006, the Company entered into a separation agreement with its former Chairman and
Chief Executive Officer following his resignation on March 14, 2006. In March 2006, the Company
recorded total severance charges of approximately $915,000 in connection with the separation
agreement, which is included in general and administrative expense. In accordance with the
separation agreement, the Company set aside approximately $874,000 in restricted cash in order to
meet the severance obligations under this agreement. As of September 30, 2006, the Company had
paid $893,000 in accordance with the separation agreement.
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 (SFAS 146),
the Company recorded total restructuring charges of approximately $1,488,000 in connection with the
termination of 60 employees (approximately $1,174,000), the impairment of certain long-term assets
(approximately $152,000), and retention payments for key executives (approximately $162,000). This
action followed an announcement by the Company in March 2005 that, based on the outcome of a
meeting with the FDA, the Companys lead drug candidate, Riquent®, was unlikely to receive
accelerated approval under the FDAs Subpart H regulation.
In fiscal 2005, approximately $991,000 of the total restructuring charges was included in research
and development expense and approximately $497,000 was included in general and administrative
expense. The restructuring plan was completed in September 2005 and actual total charges paid were
approximately $1,336,000. The non-cash charge of $152,000 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. Stockholders Equity
Stock Option Plans
In 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan (the
1994 Plan), under which, as amended, 1,640,000 shares of common stock (post-reverse stock split)
were authorized for issuance. The 1994 Plan expired in June 2004 and there remained 1,174,704
options outstanding under the 1994 Plan as of September 30, 2006.
In 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan (the
2004 Plan), under which, as amended, 4,160,000 shares of common stock (post-reverse stock split)
have been authorized for issuance. The 2004 Plan provides for the grant of incentive and
non-qualified stock options, as well as other share-based payment awards, to employees, directors,
consultants and advisors of the Company with up to a 10 year contractual life and various vesting
periods as determined by the Companys compensation committee or the board of directors, as well as
automatic fixed grants to non-employee directors of the Company. As of September 30, 2006, there
were a total of 3,178,221 options outstanding and 54,398 unvested shares of restricted stock
granted under the 2004 Plan and 876,364 shares remained available for future grant.
9
Exercise prices and weighted-average remaining contractual lives for the options outstanding
(excluding shares of restricted stock) as of September 30, 2006 were:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
Average |
|
Weighted- |
|
|
|
|
|
Exercise |
|
|
|
|
|
|
Remaining |
|
Average |
|
|
|
|
|
Price of |
Options |
|
Range of Exercise |
|
Contractual Life |
|
Exercise |
|
Options |
|
Options |
Outstanding |
|
Prices |
|
(in years) |
|
Price |
|
Exercisable |
|
Exercisable |
|
791,182 |
|
$ |
1.72 - $3.99 |
|
|
|
8.31 |
|
|
$ |
3.05 |
|
|
|
307,813 |
|
|
$ |
2.33 |
|
373,041 |
|
$ |
4.03 - $4.30 |
|
|
|
9.03 |
|
|
$ |
4.20 |
|
|
|
199,441 |
|
|
$ |
4.20 |
|
1,133,605 |
|
$ |
4.46 |
|
|
|
9.55 |
|
|
$ |
4.46 |
|
|
|
159,599 |
|
|
$ |
4.46 |
|
831,689 |
|
$ |
4.90 - $10.60 |
|
|
|
9.40 |
|
|
$ |
5.29 |
|
|
|
9,390 |
|
|
$ |
7.51 |
|
588,609 |
|
$ |
13.13 - $23.13 |
|
|
|
5.46 |
|
|
$ |
16.59 |
|
|
|
475,368 |
|
|
$ |
16.95 |
|
634,799 |
|
$ |
23.55 - $60.31 |
|
|
|
5.39 |
|
|
$ |
30.88 |
|
|
|
634,799 |
|
|
$ |
30.88 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
4,352,925 |
|
$ |
1.72 - $60.31 |
|
|
|
8.09 |
|
|
$ |
9.83 |
|
|
|
1,786,410 |
|
|
$ |
16.79 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Employee Stock Purchase Plan
In 1995, the Company adopted the ESPP, under which, as amended, 600,000 shares of common stock are
reserved for sale to eligible employees, as defined in the ESPP. Employees may purchase common
stock under the ESPP every three months (up to but not exceeding 10% of each employees base salary
or hourly compensation, and any cash bonus paid, subject to certain limitations) over the offering
period at 85% of the fair market value of the common stock at specified dates. The offering period
may not exceed 24 months. During the nine months ended September 30, 2006, 64,722 shares of common
stock were issued under the ESPP at prices ranging from $3.06 to $3.19 per share. As of September
30, 2006, 416,687 shares of common stock have been issued under the ESPP and 183,313 shares of
common stock are available for future issuance.
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 or models 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 previous
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 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 SSAO inhibitor program is at a very early stage of development and involves comparable risks.
Analysis of our clinical trials could have negative or
10
inconclusive results. Any positive results observed to date in our clinical trials or animal
models may not be indicative of future results. In any event, regulatory authorities may require
clinical trials in addition to our current clinical trials, 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: obtaining required regulatory approvals, including delays associated with any approvals
that we may obtain; our ability to pass all necessary regulatory inspections; the availability of
sufficient financial resources; the increase in capacity of our manufacturing capabilities for
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 Annual Report on Form 10-K for
the year ended December 31, 2005, and in other reports and registration statements that we file
with the Securities and Exchange Commission from time to time.
Developments in 2006
On January 11, 2006, we announced that we would initiate a multi-dose clinical study of
Riquent in lupus patients to evaluate the ability of higher doses of Riquent to further reduce
antibodies to double stranded DNA. This study is part of our overall clinical development program
of Riquent, which includes the ongoing Phase 3 clinical benefit trial to evaluate the use of
Riquent in preventative and acute settings.
On January 12, 2006, we announced that we had regained compliance with the Nasdaq Stock Market
minimum bid price rule and that we were eligible to remain listed on the Nasdaq Global Market.
On March 15, 2006, we announced that Deirdre Y. Gillespie, M.D. was appointed to serve as our
new President and Chief Executive Officer following the resignation of Steven B. Engle on March 14,
2006. We also announced that our board of directors had appointed Craig R. Smith, M.D., a current
independent director, to serve as Chairman of the board.
On June 22, 2006, we announced that our Marketing Authorization Application (MAA) had been
accepted for review by the European Medicines Agency (EMEA) for potential approval to market
Riquent in the European Union (EU). The MAA was filed with the EMEA on March 31, 2006. The
EMEAs review of the MAA would follow its centralized marketing authorization procedure. If
approved, Riquent would receive marketing authorization in all 25 EU member states as well as
Norway, Iceland and Liechtenstein. Riquent has already received orphan medicinal product
designation in Europe, which will provide 10 years of market exclusivity from the date of EU
authorization.
On July 17, 2006, we announced that Michael Tansey, M.D. had joined the Company as Chief
Medical Officer on a part-time basis, whereby 65% of his time is devoted to his position with the
Company.
On August 9, 2006, we announced that we had reactivated enrollment in our Phase 3 trial of
Riquent.
On September 27, 2006, we announced that we had made considerable progress on our Phase 3
trial of Riquent. Since our August 9, 2006 announcement regarding reactivation of enrollment, we
had added 27 clinical trial sites able to screen and enroll patients for a total of 58 sites (22 in
the U.S. and 36 in Asia).
On October 12, 2006, we announced that we had requested the withdrawal of our MAA. In a
preliminary assessment of the MAA, the EMEA reviewers indicated that additional clinical data would
be needed prior to potential approval. Based on our review of the assessment, we believe that the
ongoing clinical studies of Riquent should provide the necessary data; however, the data will not
be available within the timeframe that the EMEA regulations allow for the review of the current
Riquent application. Therefore, we decided to withdraw the current application, and plan to refile
the MAA after the completion
of the ongoing clinical trials.
11
On November 6, 2006, we announced that we had
made significant progress in enrolling patients and opening sites for
our Phase 3 clinical trial of Riquent. To date, 82 patients have been
enrolled in the study, with 40 patients randonized in October. More
than 150 additional patients are currently in screening for potential
enrollment in the study. We have activated 65 clinical trial sites,
including newly added sites in Europe.
Overview
Since our inception in May 1989, we have devoted substantially all of our resources to the
research and development of technology and potential drugs to treat antibody-mediated diseases. We
have never generated any revenue from product sales and have relied on public and private offerings
of securities, revenue from collaborative agreements, equipment financings and interest income on
invested cash balances for our working capital. We expect that our research and development
expenses will increase significantly in the future. For example, we have initiated a Phase 3
clinical trial of Riquent which 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 600 patients and take several years to complete. Therefore, we expect to expend
substantial amounts of capital resources for the clinical development and manufacturing of Riquent.
We may also devote substantial additional capital resources to establish commercial-scale
manufacturing capabilities and to market and sell potential products. These expenses may be
incurred prior to or after any regulatory approvals that we may receive. 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. Even with the net
proceeds of approximately $62.3 million from the fundraising that we completed in December 2005, we
expect that we will need additional funds to finance our future operations. 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, 2006, our
accumulated deficit was approximately $289.1 million.
Our business is subject to significant risks, including, but not limited to, the risks
inherent in research and development efforts, including clinical trials, the lengthy, expensive and
uncertain process of seeking regulatory approvals, the need for additional financing or a
collaborative partner, 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.
CRITICAL ACCOUNTING POLICIES
Other than the adoption of SFAS 123R, as discussed below, there were no significant changes in
critical accounting policies or estimates from those at December 31, 2005. For additional
information on the recent accounting pronouncements impacting our business, see Note 1 of the Notes
to Condensed Consolidated Financial Statements included in Item 1.
12
Share-Based Compensation
We adopted SFAS 123R using the modified prospective transition method, which requires the
application of the accounting standard as of January 1, 2006, the first day of our 2006 fiscal
year. Our Condensed Consolidated Statements of Operations as of and for the three and nine months
ended September 30, 2006 reflect the impact of SFAS 123R. In accordance with the modified
prospective transition method, our Condensed Consolidated Statements of Operations for prior
periods have not been restated to reflect, and do not include, the impact of SFAS 123R. Share-based
compensation expense recognized under SFAS 123R for the three and nine months ended September 30,
2006 was $1.1 million and $4.2 million, respectively. As of September 30, 2006, there was $9.2
million of total unrecognized compensation cost related to non-vested share-based payment awards
granted under all equity compensation plans. Total unrecognized compensation cost will be adjusted
for future changes in estimated forfeitures. We currently expect to recognize the remaining
unrecognized compensation cost over a weighted-average period of 1.3 years. Additional share-based
compensation expense for any new share-based payment awards granted after September 30, 2006 under
all equity compensation plans cannot be predicted at this time because it will depend on, among
other matters, the amounts of share-based payment awards granted in the future.
Prior to January 1, 2006, we had adopted the disclosure-only provision of SFAS 123.
Accordingly, we had not previously recognized compensation expense, except for compensation expense
related to stock options granted to consultants and restricted stock granted to certain members of
management. Had we recognized compensation expense in accordance with SFAS 123 for the three and
nine months ended September 30, 2005, our net loss would have increased by $0.8 million and $3.0
million or $0.05 and $0.21 per basic and diluted share, respectively.
Results of Operations
For the three months ended September 30, 2006, research and development expenses increased to
$7.7 million from $5.0 million for the same period in 2005. This increase was primarily due to an
increase in Riquent-related drug production and clinical trial expenses of approximately $1.6
million, share-based compensation expense of approximately $0.4 million recorded in connection with
the January 1, 2006 adoption of SFAS 123R and an increase of approximately $0.2 million in
Riquent-related consulting expenses.
For the nine months ended September 30, 2006, research and development expenses increased to
$23.8 million from $17.5 million for the same period in 2005. This increase was primarily due to
an increase in Riquent-related drug production and clinical trial expenses of approximately $4.7
million. In addition, this increase was due to share-based compensation expense of approximately
$1.6 million recorded in connection with the adoption of SFAS 123R and an increase of approximately
$0.6 million in Riquent-related consulting expenses. These increases were partially offset by a
decrease in termination benefits, mainly relating to severance, of approximately $1.0 million that
was recorded in 2005 in connection with the termination of 44 research and development personnel
and the savings in salaries and related expenses as a result of this reduction in personnel.
Research and development expense of $7.7 million for the three months ended September 30, 2006
consisted of $7.0 million for lupus research and development related expense and $0.7 million for
SSAO research and development related expense. Research and development expense of $23.8 million
for the nine months ended September 30, 2006 consisted of $20.6 million for lupus research and
development related expense and $3.2 million for SSAO research and development related expense.
For the three and nine months ended September 30, 2006, total lupus research and development
expense consisted primarily of salaries, production and clinical trial costs related to Riquent,
share-based compensation expense and other costs related to research, manufacturing and clinical
personnel and consulting and professional outside services. For the three and nine months ended
September 30, 2006, total SSAO related research and development expense consisted primarily of
salaries, share-based compensation expense and other costs for research and development personnel,
research supplies and rent and lease expense.
We expect that our research and development expense will increase significantly in the future.
For example, we have initiated a Phase 3 clinical trial of Riquent which 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 600 patients and take several years to complete.
As patient
13
enrollment expands, we will be required to manufacture more Riquent and our manufacturing
expenses will increase. 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 our SSAO program, future
development depends on our ability to obtain third party financing
for this program including through a joint venture, partnership or
other collaborative arrangement.
For the three months ended September 30, 2006, general and administrative expense increased to
$1.5 million from $1.1 million for the same period in 2005. This increase was primarily due to
share-based compensation expense of approximately $0.7 million recorded in connection with the
adoption of SFAS 123R. This increase was partially offset by selected patent and license
write-offs of approximately $0.2 million recorded in 2005.
For the nine months ended September 30, 2006, general and administrative expense increased to
$7.2 million from $4.2 million for the same period in 2005. This increase was primarily due to
share-based compensation expense of approximately $2.6 million recorded in connection with the
adoption of SFAS 123R. This increase was also due to the expense of approximately $0.9 million
recorded in the first quarter of 2006 for severance to our former Chairman and Chief Executive
Officer and an increase of approximately $0.5 million in general corporate consulting and
professional outside services. These increases were partially offset by a decrease in termination
benefits, mainly related to severance, of approximately $0.5 million that was recorded in 2005 in
connection with the termination of 16 general and administrative personnel and the savings in
salaries and related expenses as a result of this reduction in personnel.
We expect that our general and administrative expense will increase in the future to support
our ongoing clinical trials as patient enrollment and the manufacturing of Riquent increases.
Additionally, general and administrative expense may increase in the future if there is an increase
in research and development or commercialization activities.
Interest income, net increased to $0.7 million for the three months ended September 30, 2006
from $0.1 million for the same period in 2005. Interest income, net increased to $2.2 million for
the nine months ended September 30, 2006 from $0.4 million for the same period in 2005. These
increases were primarily due to higher average balances of cash, cash equivalents and short-term
investments and higher average interest rates as compared to the same period in 2005.
Liquidity and Capital Resources
From inception through September 30, 2006, we have incurred a cumulative net loss of
approximately $289.1 million and have financed our operations through public and private offerings
of securities, revenues from collaborative agreements, equipment financings and interest income on
invested cash balances. From inception through September 30, 2006, we have raised approximately
$336.8 million in net proceeds from sales of equity securities.
At September 30, 2006, we had $50.2 million in cash, cash equivalents and short-term
investments, as compared to $72.9 million at December 31, 2005. Our working capital at September
30, 2006 was $46.6 million, as compared to $70.1 million at December 31, 2005. 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. We invest our cash in United States government-backed securities and
debt instruments of corporations with strong credit ratings. As of September 30, 2006,
available-for-sale securities and cash equivalents of $17.9 million have stated maturity dates of
one year or less and $31.0 million have maturity dates after one year. Securities that have a
maturity date greater than one year have their interest rate reset periodically within time periods
not exceeding 92 days.
As
of September 30, 2006, approximately $1.7 million of
equipment ($0.6 million net of depreciation) 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 obtain
14
regulatory approval. The agreement includes a cancellation fee of $0.4 million. We have also
entered into non-cancelable purchase commitments for an aggregate of $0.6 million with third-party
manufacturers of materials to be used in the production of Riquent. 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 expand our research and development
and manufacturing facilities and capabilities.
The following table summarizes our contractual obligations at September 30, 2006 (in
thousands). Long-term debt obligations include interest.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment due by period |
|
|
|
|
|
|
Less than |
|
|
|
|
|
3-5 |
|
More than |
|
|
Total |
|
1 Year |
|
1-3 Years |
|
Years |
|
5 Years |
Long-Term Debt Obligations |
|
$ |
200 |
|
|
$ |
189 |
|
|
$ |
11 |
|
|
$ |
|
|
|
$ |
|
|
Operating Lease Obligations |
|
|
2,560 |
|
|
|
847 |
|
|
|
1,687 |
|
|
|
26 |
|
|
|
|
|
Purchase Obligations |
|
|
1,017 |
|
|
|
1,017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,777 |
|
|
$ |
2,053 |
|
|
$ |
1,698 |
|
|
$ |
26 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
We intend to use our financial resources to fund the current clinical trials of Riquent,
possible future clinical trials, manufacturing activities, research and development efforts and for
working capital and other general corporate purposes. The amounts that we actually spend for each
purpose may vary significantly depending on a number of factors, including the timing of any
regulatory applications and approvals, the outcome of our meetings with regulatory authorities,
results from current and future clinical trials, the continued analysis of the clinical trial data
of Riquent, 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.
We anticipate that our existing cash, cash investments, including the net proceeds of $62.3
million that we received from the sale of common stock and warrants in December 2005, and the
interest earned thereon, will be sufficient to fund our operations as currently planned into the
first quarter of 2008. 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 and that we do not engage in any significant commercialization activities
or significant activities in our other research programs. We will continually evaluate our planned
activities. Any significant change in our planned activities or in the assumptions underlying our
cash projection referred to above could result in a change to such cash projection.
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, will take a
significant 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. If our cash requirements
exceed our current projections, we may need additional financing sooner than currently expected.
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 may worsen as we continue
to use existing resources or if the development of Riquent is delayed or terminated. There is also
no assurance that we will be able to enter into further collaborative relationships. In the
future, it is possible that we will not have adequate resources to support continuation of our
business activities.
15
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 which 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 92 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 defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended), as of
September 30, 2006. Based on this evaluation, our principal executive and principal financial
officers concluded that our disclosure controls and procedures were effective as of September 30,
2006. There was no change in our internal control over financial reporting during the quarter
ended September 30, 2006 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
PART II. OTHER INFORMATION
ITEM 1A. RISK FACTORS
An amended and restated description of certain risk factors associated with our business is
set forth below. The following discussion includes material changes to and supersedes the risk
factors that we previously disclosed in our Annual Report on Form 10-K for the fiscal year ended
December 31, 2005 and the updated discussion that we disclosed in our Quarterly Report on Form 10-Q
for the period ended June 30, 2006.
Results
from our clinical trials may not be sufficient to obtain regulatory
approvals to market Riquent or our
other drug candidates in the United States or Europe on a timely
basis, if at all.
Our drug candidates are subject to extensive government regulations related to development,
clinical trials, manufacturing and commercialization. In order to sell any product that is under
development, we must first receive regulatory approval. To obtain regulatory approval, we must
conduct clinical trials and toxicology studies that demonstrate that our drug candidates are safe
and effective. The process of obtaining FDA and foreign regulatory approvals is costly, time
consuming, uncertain and subject to unanticipated delays.
The FDA and foreign regulatory authorities have substantial discretion in the approval process
and may not agree that we have demonstrated that Riquent is safe and effective. If Riquent is
ultimately not found to be safe and effective, we would be unable to obtain regulatory approval to
manufacture, market and sell Riquent. Although we have received an approvable letter from the FDA,
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. In a preliminary assessment of
the MAA, the EMEA reviewers indicated that additional
clinical data would be needed prior to potential approval. Based on
our reviews of the
assessment, we believe that the ongoing clinical studies of Riquent should provide the
necessary data; however, the data will not be available within the timeframe that the
EMEA regulations allow for the review of the current Riquent application. Therefore,
we decided to withdraw the current application, and plan to refile the MAA after the
completion of the ongoing clinical trials. We
can provide no assurances that the FDA or foreign regulatory authorities will ultimately approve
Riquent or, if approved, what the indication for Riquent will be.
As currently designed, our ongoing Phase 3 trial contains multiple dosing levels. Even if the
Phase 3 clinical trial is successful, the FDA or foreign regulatory authorities may require
additional studies to define dosing recommendations before we can obtain approval to market
Riquent.
16
Because Riquent is our only drug candidate for which we have completed a Phase 3 clinical
trial, and because there is no guarantee that we would be able to develop an alternate drug
candidate, our
inability to obtain any regulatory approval of Riquent would have a severe negative effect on our
business, and, in the future, we may not have the financial resources to continue research and
development of Riquent or any other potential drug candidates.
We may not have sufficient financial resources to complete the ongoing Phase 3 clinical benefit
trial of Riquent.
We will need to successfully complete the ongoing Phase 3 clinical benefit study of Riquent
prior to any FDA or any foreign regulatory approvals. We expect that the ongoing Phase 3 clinical
benefit trial will involve approximately 600 patients and take several years to complete. Although
we raised net proceeds of approximately $62.3 million from the sale of common stock and warrants in
December 2005, we expect that the actual costs of completing the ongoing Phase 3 clinical benefit
trial of Riquent will exceed our current cash resources. If we expend all of the funds that we have
raised and do not receive funding from a collaborative agreement with a corporate partner or obtain
other financing, we would not have the financial resources to complete the ongoing Phase 3 clinical
benefit trial or to continue the research and development of Riquent, and it would be difficult or
impossible for us to continue to operate.
We will need additional funds to support our operations.
Our operations to date have consumed substantial capital resources. Before we can obtain FDA
or foreign regulatory approval for Riquent, we will need to successfully complete the ongoing Phase 3 clinical
benefit trial and possibly additional trials. Therefore, we expect to expend substantial amounts of
capital resources for additional research, product development, pre-clinical testing and clinical
trials of Riquent. We may also devote substantial additional capital resources to establish
commercial-scale manufacturing capabilities and to market and sell potential products. These
expenses may be incurred prior to or after any regulatory approvals that we may receive. Even with
the net proceeds of approximately $62.3 million from our stock and warrant offering in December
2005, we expect that we would need additional funds to finance our future operations. Our future
capital requirements would depend on many factors, including:
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|
the scope and results of our clinical trials; |
|
|
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|
our ability to manufacture sufficient quantities of drug to support clinical trials; |
|
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|
our ability to obtain regulatory approval for Riquent; |
|
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|
the time and costs involved in applying for regulatory approvals; |
|
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|
continued scientific progress in our research and development programs; |
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|
the size and complexity of our research and development programs; |
|
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|
|
the costs involved in preparing, filing, prosecuting, maintaining and
enforcing patent claims; |
|
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|
competing technological and market developments; |
|
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|
our ability to establish and maintain collaborative research and
development arrangements; |
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|
our need to establish commercial manufacturing capabilities; and |
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|
|
our ability to develop effective marketing and sales programs. |
We expect to incur substantial losses each year for at least the next several years as we
continue our planned clinical trial, manufacturing, regulatory, and research and development
activities. If we receive regulatory approval for Riquent, or any of our other drug candidates, our
manufacturing, marketing and sales activities are likely to substantially increase our expenses and
our need for additional working capital. In the future, it is possible that we will not be able to
obtain additional funds and thus not
have adequate resources to support continuation of our business activities.
17
We are currently devoting nearly all of our resources to the development and approval of Riquent.
Accordingly, our efforts with respect to other drug candidates have significantly diminished.
We have currently budgeted only a limited amount of funds for the development of small
molecules for the treatment of autoimmune diseases and acute and chronic inflammatory disorders.
Future development of these drug candidates depends on our ability to obtain third party financing
for this program including through a joint venture, partnership or
other collaborative arrangement. As a result, significant progress with respect to drug
candidates other than Riquent, if any, will be significantly delayed and our success and ability to
continue to operate depends on whether we obtain regulatory approval to market Riquent.
Our efforts to obtain approval to market Riquent in Europe may be delayed or unsuccessful.
In order to obtain approval to market Riquent in Europe, we must submit an MAA to and pass
inspections of the European health authority. The MAA was submitted with the EMEA on March 31,
2006. In October 2006, we requested the withdrawal of our MAA based on a preliminary assessment of
the MAA whereby the EMEA reviewers indicated that additional clinical data would be needed prior to
potential approval. Based on our review of the assessment, we believe that the ongoing clinical
studies of Riquent should provide the necessary data; however, the data will not be available
within the timeframe that the EMEA regulations allow for the review of the current Riquent
application. Therefore, we decided to withdraw the current application, and plan to refile the MAA
after the completion of the ongoing clinical trials. If and when we refile the MAA, the approval
process may be delayed again because, among other matters: the EMEA may require additional tests to
be conducted; we, or one of our contract manufacturing facilities, may be unable to successfully
pass an inspection by the European health authority; or the European health authority ultimately
may not accept the data presented in the MAA in combination with our proposals for
post-authorization commitments as adequate for approval. In addition, we must manufacture three
consecutive lots of Riquent to validate our manufacturing process as part of the MAA approval
process. If we receive approval in Europe, post-authorization commitments, including additional
clinical studies, may be required. If we fail to successfully complete these post-authorization
commitments to the satisfaction of the European health authorities, our license to market Riquent
in Europe, if any, could be revoked.
Our blood test to measure the binding affinity for Riquent has not been validated by independent
laboratories, is likely to require regulatory review as part of the Riquent approval process and
results to date may not be reproduced in current or future clinical trials.
In 1998, we developed a blood test intended to identify the lupus patients who are most likely
to respond to Riquent. The blood test was designed to measure the strength of the binding between
Riquent and a patients antibodies. This affinity assay was used to identify, prospectively in the
Phase 3 trial and retrospectively in the Phase 2/3 trial, the patients included in the efficacy
analyses. Independent laboratories have not validated the assay, and the results of the affinity
assay observed in our previous clinical trials of Riquent may not be reproducible in current or
future clinical trials or may not be observed in the broader lupus patient population. Although the
FDA has reviewed the assay as part of the NDA review process of Riquent, the FDAs review of the
assay will not be complete until after Riquent is approved, if ever, and we and the FDA agree upon
the label for Riquent. In addition, foreign regulatory authorities may require that the assay be
reviewed as part of their approval process for Riquent. Even if Riquent and the assay are approved
by the FDA or foreign regulatory authorities, we may be required to conduct additional studies on the
assay post-approval. Additional regulatory approval may be required
for the testing laboratory that conducts the assay if Riquent is approved. If the FDA or foreign regulatory authorities do not
concur with the use of the assay to identify potential patients for treatment with Riquent, or if
any of them requires additional studies on the assay or additional regulatory approval of the
testing laboratory, the approval and possible commercialization of Riquent may be delayed or
prevented, which would have a severe negative effect on our business.
18
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
3.1
|
|
Restated Certificate of Incorporation (1) |
|
|
|
3.2
|
|
Amended and Restated Bylaws (2) |
|
|
|
3.3
|
|
Form of Common Stock Certificate (3) |
|
|
|
4.1
|
|
Rights Agreement, dated as of December 3, 1998, between the Company
and American Stock Transfer & Trust Company (4) |
|
|
|
4.2
|
|
Amendment No. 1 to the Rights Agreement, dated as of July 21, 2000,
between the Company and American Stock Transfer & Trust Company (5) |
|
|
|
4.3
|
|
Amendment No. 2 to the Rights Agreement, dated as of December 14,
2005, between the Company and American Stock Transfer & Trust Company
(6) |
|
|
|
4.4
|
|
Amendment No. 3 to the Rights Agreement, dated as of March 1, 2006,
between the Company and American Stock Transfer & Trust Company (1) |
|
|
|
10.1
|
|
Employment Offer Letter, dated July 10, 2006 and executed July 14,
2006, by and between the Company and Michael Tansey, M.D. (7)* |
|
|
|
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 Current Report on Form 8-K filed March 1, 2006 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 S-3 (Registration
No. 333-131246) filed January 24, 2006 and incorporated by reference herein. |
|
(4) |
|
Previously filed with the Companys Registration Statement on Form 8-A (Registration
No. 000-24274) filed December 4, 1998 and incorporated by reference herein. |
|
(5) |
|
Previously filed with the Companys Current Report on Form 8-K filed 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 Current Report on Form 8-K filed December 16, 2005
and incorporated by reference herein. |
|
(7) |
|
Previously filed with the Companys Current Report on Form 8-K filed July 18, 2006 and
incorporated by reference herein. |
19
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
La Jolla Pharmaceutical Company
|
|
Date: November 7, 2006 |
/s/ Deirdre Y. Gillespie
|
|
|
Deirdre Y. Gillespie, M.D. |
|
|
President and Chief Executive Officer
(On behalf of the Registrant) |
|
|
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|
|
|
/s/ Gail A. Sloan
|
|
|
Gail A. Sloan |
|
|
Vice President of Finance and Secretary
(As Principal Financial and Accounting Officer) |
|
|
20
LA JOLLA PHARMACEUTICAL COMPANY
INDEX TO EXHIBITS
(Exhibits Physically Filed Herewith)
|
|
|
Exhibit |
|
|
Number |
|
Description |
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 |