e10vq
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2008
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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San Diego, CA
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92121 |
(Address of principal executive offices) |
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(Zip Code) |
Registrants telephone number, including area code: (858) 452-6600
Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days.
Yes
þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a
non-accelerated filer or a smaller reporting company. See the
definitions of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer þ
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Non-accelerated filer o
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Smaller reporting company o |
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(Do not check if a smaller reporting company) |
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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 o No þ
The number of shares of the registrants common stock, $0.01 par value per share, outstanding at
August 1, 2008 was 55,325,834.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED CONSOLIDATED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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June 30, |
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December 31, |
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2008 |
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2007 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
31,719 |
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$ |
4,373 |
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Short-term investments |
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9,021 |
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34,986 |
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Prepaids and other current assets |
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1,490 |
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1,018 |
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Total current assets |
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42,230 |
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40,377 |
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Property and equipment, net |
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1,268 |
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1,271 |
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Patent costs and other assets, net |
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2,710 |
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2,757 |
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Total assets |
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$ |
46,208 |
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$ |
44,405 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
2,184 |
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$ |
2,203 |
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Accrued clinical/regulatory expenses |
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6,108 |
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6,282 |
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Accrued expenses |
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661 |
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664 |
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Accrued payroll and related expenses |
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1,321 |
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1,199 |
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Current portion of obligations under notes payable |
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144 |
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138 |
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Current portion of obligations under capital leases |
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9 |
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10 |
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Total current liabilities |
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10,427 |
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10,496 |
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Noncurrent portion of obligations under notes payable |
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263 |
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344 |
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Noncurrent portion of obligations under capital leases |
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40 |
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44 |
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Commitments |
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Stockholders equity: |
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Common stock |
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553 |
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396 |
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Additional paid-in capital |
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416,330 |
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385,944 |
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Other comprehensive income |
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14 |
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Accumulated deficit |
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(381,405 |
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(352,833 |
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Total stockholders equity |
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35,478 |
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33,521 |
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Total liabilities and stockholders equity |
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$ |
46,208 |
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$ |
44,405 |
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Note: The condensed consolidated balance sheet at December 31, 2007 has been derived from the
audited consolidated financial statements as of that date but does not include all of the
information and disclosures required by U.S. generally accepted accounting principles.
See accompanying notes.
1
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share amounts)
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Three Months Ended |
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Six Months Ended |
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June 30, |
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June 30, |
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2008 |
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2007 |
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2008 |
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2007 |
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Expenses: |
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Research and development |
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$ |
12,732 |
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$ |
12,186 |
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$ |
24,070 |
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$ |
22,561 |
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General and administrative |
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2,069 |
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2,112 |
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3,975 |
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4,092 |
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Total expenses |
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14,801 |
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14,298 |
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28,045 |
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26,653 |
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Loss from operations |
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(14,801 |
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(14,298 |
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(28,045 |
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(26,653 |
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Interest income |
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130 |
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838 |
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490 |
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1,332 |
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Interest expense |
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(44 |
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(57 |
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(60 |
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(66 |
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Realized loss on investments, net |
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(220 |
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(957 |
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Net loss |
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$ |
(14,935 |
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$ |
(13,517 |
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$ |
(28,572 |
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$ |
(25,387 |
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Basic and diluted net loss per share |
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$ |
(0.31 |
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$ |
(0.34 |
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$ |
(0.65 |
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$ |
(0.70 |
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Shares used in computing basic and
diluted net loss per share |
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48,252 |
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39,256 |
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43,941 |
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36,015 |
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See accompanying notes.
2
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Statements of Cash Flows
(Unaudited)
(in thousands)
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Six Months Ended |
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June 30, |
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2008 |
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2007 |
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Operating activities: |
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Net loss |
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$ |
(28,572 |
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$ |
(25,387 |
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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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519 |
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885 |
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Loss on write-off/disposal of patents and property and equipment |
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138 |
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75 |
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Share-based compensation expense |
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2,297 |
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2,579 |
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Realized loss on investments, net |
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957 |
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Amortization of premium (discount) on investments |
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329 |
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(91 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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(472 |
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(165 |
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Accounts payable |
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(19 |
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(1,009 |
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Accrued clinical/regulatory expenses |
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(174 |
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2,339 |
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Accrued expenses |
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(3 |
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135 |
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Accrued payroll and related expenses |
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122 |
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(100 |
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Net cash used for operating activities |
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(24,878 |
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(20,739 |
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Investing activities: |
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Purchases of short-term investments |
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(38,415 |
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Sales of short-term investments |
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24,665 |
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20,750 |
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Additions to property and equipment |
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(446 |
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(81 |
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Increase in patent costs and other assets |
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(161 |
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(462 |
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Net cash provided by (used for) investing activities |
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24,058 |
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(18,208 |
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Financing activities: |
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Net proceeds from issuance of common stock |
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28,246 |
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38,527 |
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Proceeds from issuance of notes payable |
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75 |
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Payments on obligations under notes payable |
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(75 |
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(127 |
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Payments on obligations under capital leases |
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(5 |
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Net cash provided by financing activities |
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28,166 |
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38,475 |
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Net increase (decrease) in cash and cash equivalents |
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27,346 |
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(472 |
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Cash and cash equivalents at beginning of period |
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4,373 |
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3,829 |
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Cash and cash equivalents at end of period |
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$ |
31,719 |
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$ |
3,357 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
60 |
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$ |
66 |
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Supplemental schedule of noncash investing and financing
activities: |
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Net unrealized losses (gains) on available-for-sale investments |
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$ |
14 |
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$ |
(14 |
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
June 30, 2008
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company and its wholly-owned subsidiary (the Company) have been prepared in accordance with U.S.
generally accepted accounting principles (GAAP) for interim financial information and with the
instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all
of the information and disclosures required by GAAP for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring accruals and the realized
impairment loss on investments see Note 3 for further details) considered necessary for a fair
presentation have been included. Operating results for the three and six months ended June 30,
2008 are not necessarily indicative of the results that may be expected for other quarters or the
year ended December 31, 2008. For more complete financial information, these unaudited condensed
consolidated financial statements, and the notes thereto, should be read in conjunction with the
audited consolidated financial statements for the year ended December 31, 2007 included in the
Companys Form 10-K filed with the Securities and Exchange Commission.
The Company has a history of recurring losses from operations and has an accumulated deficit of
$381,405,000 as of June 30, 2008. As of June 30, 2008, the Company had available cash and cash
equivalents totaling $31,719,000 and working capital of $31,803,000. As of June 30, 2008, there was
insufficient demand at auction for each of the Companys remaining four AAA rated asset-backed
student loan auction rate securities, representing its short-term investments of approximately
$9,021,000 (net of a realized impairment loss of $990,000 recorded in the first six months of
2008). As a result of this insufficient demand, these four securities are currently not liquid.
The Company expects that the current cash resources, excluding the value of its currently illiquid
auction rate securities, will enable it to continue its operations as currently planned through
December 31, 2008. However, there is a substantial doubt about the Companys ability to continue as
a going concern beyond fiscal 2008. The accompanying unaudited condensed consolidated financial
statements have been prepared assuming that the Company will continue as a going concern. This
basis of accounting contemplates the recovery of the Companys assets and the satisfaction of
liabilities in the normal course of business and does not include any adjustments to reflect the
possible future effects on the recoverability and classification of assets or the amounts and
classification of liabilities that might be necessary should the Company be unable to continue as a
going concern.
The Company continues to seek additional funding, including through collaborative arrangements and
debt or equity financings, to finance its continuing development efforts and to commercialize its
technologies. The Company believes that additional funds can be obtained in the near future;
however, there is no assurance such funds will be available to the Company when needed or that such
funds would be available under favorable terms. In the event that the Company cannot obtain
additional funds in the near future, the Company has the ability and intent to cut back on certain
expenditures and/or reduce its operations, including halting its ongoing Phase 3 clinical trial of
Riquent and significantly reducing its workforce, which would have an adverse impact on completing
its development efforts in a timely manner.
2. Accounting Policies
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of La
Jolla Pharmaceutical Company and its wholly-owned subsidiary, La Jolla Limited, which was
incorporated in England in October 2004. There have been no significant transactions related to La
Jolla Limited since its inception.
4
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 unaudited condensed
consolidated financial statements. Actual results could differ materially from those estimates.
Recent Accounting Pronouncement
On January 1, 2008, the Company adopted the provisions of Financial Accounting Standards Board
(FASB) 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. See Note 3 for further details on the impact of
the adoption of SFAS 157 on the Companys unaudited condensed consolidated results of operations
and financial condition for the three and six months ended June 30, 2008.
On January 1, 2008, the Company adopted the provisions of FASB SFAS No. 159, The Fair Value Option
for Financial Assets and Financial Liabilities Including an amendment of FASB Statement No. 115
(SFAS 159). SFAS 159 permits entities to choose to measure many financial assets and financial
liabilities at fair value. Unrealized gains and losses on items for which the fair value option has
been elected are reported in earnings. At this time, the Company has not elected to account for any
of its financial assets or liabilities using the provisions of SFAS 159. As such, the adoption of
SFAS 159 did not have an impact on the Companys unaudited condensed consolidated results of
operations and financial condition for the three and six months ended June 30, 2008.
In June 2007, FASB ratified the consensus reached by the Emerging Issues Task Force (EITF) on
EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to Be Used
in Future Research and Development Activities (EITF 07-3). EITF 07-3 addresses the diversity that
exists with respect to the accounting for the non-refundable portion of a payment made by a
research and development entity for future research and development activities. Under EITF 07-3, an
entity would defer and capitalize non-refundable advance payments made for research and development
activities until the related goods are delivered or the related services are performed. EITF 07-3
is effective for fiscal years beginning after December 15, 2007. On January 1, 2008 the Company
adopted the provisions of EITF 07-3, which did not have an impact on the Companys unaudited
condensed consolidated results of operations and financial condition for the three and six months
ended June 30, 2008.
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 unaudited 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. There were no unvested common shares subject to repurchase for the three-
and six-month periods ended June 30, 2008 and 2007.
5
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 was $14,935,000 and $13,531,000 for the three-month periods ended June 30,
2008 and 2007, respectively, and $28,586,000 and $25,401,000 for the six-month periods ended June
30, 2008 and 2007, respectively.
3. Fair Value of Financial Instruments
Cash and cash equivalents are comprised of short-term, highly liquid investments with maturities of
90 days or less from the date of purchase. Investments are comprised of available-for-sale
securities recorded at estimated fair value. Unrealized gains and losses associated with the
Companys investments, if any, are reported in stockholders equity in accordance with SFAS
No. 115, Accounting for Certain Investments in Debt and Equity Securities.
As of June 30, 2008, the Companys cash, cash equivalents and short-term investments total
$40,740,000, which is primarily invested in money market funds and AAA rated asset-backed student
loan auction rate securities. Although the credit ratings of the auction rate securities have not
deteriorated, there has been insufficient demand at auction for all four of our remaining auction
rate securities during the first half of 2008. As a result, these securities are currently not
liquid. In the event the Company needs to access the funds that are in an illiquid state, it will
not be able to do so without a loss of principal until a future auction on these auction rate
securities is successful or the securities are redeemed by the issuer at par. The Company may incur
a loss of principal if the Company is required to sell or borrow against these securities in a
privately negotiated transaction. As a result, the Company has recorded a realized impairment loss
of $990,000 in 2008. This realized loss was determined in accordance with SFAS 157, which was
adopted by the Company on January 1, 2008. The Companys auction rate securities are classified as
short-term investments, and the realized impairment loss is included in the Companys unaudited
condensed consolidated statement of operations.
As a basis for considering market participant assumptions in fair value measurements, SFAS 157
establishes a fair value hierarchy that prioritizes the inputs to valuation techniques used to
measure fair value into three broad levels. The fair value hierarchy gives the highest priority to
quoted prices in active markets for identical assets or liabilities (Level 1) and the lowest
priority to unobservable inputs (Level 3). Due to the lack of actively traded market data for the
Companys student loan auction rate securities, the value of these securities and resulting
realized impairment loss was determined using Level 3 hierarchical inputs. These inputs include
managements assumptions of pricing by market participants, including assumptions about risk. In
accordance with SFAS 157, the Company used the concepts of fair value based on estimated discounted
future cash flows of interest income over a projected five-year period reflective of the length of
time the Company anticipates it will take the securities to become
liquid. Discount rates ranging from approximately 5% to 10% were utilized when preparing this model. The Company classified all of the student
loan auction rate securities as short-term available-for-sale securities as the Company will need
additional cash in the near term and may be required to liquidate these auction rate securities in
order to continue operations. Because of the Companys inability to hold these securities until
their maturity (which ranges between 20-30 years), the Company believes the impairment of these
securities is other-than-temporary. The Company continues to seek additional funding, including
through collaborative arrangements and debt or equity financings, to finance its continuing
development efforts and to commercialize its technologies. See Note 1 for further details.
6
We measure the following financial assets at fair value on a recurring basis. The fair value of
these financial assets at June 30, 2008 (in thousands) are as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at Reporting Date Using |
|
|
|
|
|
|
Quoted prices in |
|
|
|
|
|
|
|
|
|
|
active markets |
|
Significant other |
|
Significant |
|
|
Balance at |
|
for identical |
|
observable |
|
unobservable |
|
|
June 30, |
|
assets |
|
inputs |
|
inputs |
Description |
|
2008 |
|
(Level 1) |
|
(Level 2) |
|
(Level 3) |
Cash and cash equivalents |
|
|
$ |
31,719 |
|
|
$ |
31,719 |
|
|
$ |
|
|
|
$ |
|
|
Short-term investments |
|
|
|
9,021 |
|
|
|
|
|
|
|
|
|
|
|
9,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
|
$ |
40,740 |
|
|
$ |
31,719 |
|
|
$ |
|
|
|
$ |
9,021 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table sets forth the change in estimated fair value for the Companys AAA rated
asset-backed student loan auction rate securities (in thousands).
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurement Using |
|
|
Significant Unobservable Inputs |
|
|
(Level 3) |
|
|
Three Months |
|
Six Months |
|
|
Ended |
|
Ended |
|
|
June 30, 2008 |
|
June 30, 2008 |
Beginning balance |
|
|
$ |
9,327 |
|
|
$ |
|
|
Transfers in to Level 3 |
|
|
|
|
|
|
|
10,000 |
|
Changes in interest receivable balance |
|
|
|
(86 |
) |
|
|
11 |
|
Total realized/unrealized losses |
|
|
|
|
|
|
|
|
Included in net loss |
|
|
|
(220 |
) |
|
|
(990 |
) |
Included in comprehensive loss |
|
|
|
|
|
|
|
|
|
Purchases, issuances and settlements |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ending balance |
|
|
$ |
9,021 |
|
|
$ |
9,021 |
|
|
|
|
|
|
|
|
|
4. 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 was included in general and administrative expense. The terms of the separation
agreement were completed in March 2008 and the actual amounts paid under the separation agreement
were approximately $915,000.
5. Stockholders Equity
Common Stock
On May 12, 2008, the Company sold 15,614,834 Units (the Units, where each Unit
consists of one share of common stock, $0.01 par value per share (the Common Stock) and a warrant
to purchase 0.25 shares of Common Stock) in an underwritten public offering at a price per Unit of
$1.92125, for net proceeds totalling approximately $28,107,000. The warrants, which represent the
right to acquire a total of 3,903,708 shares of common stock, will be exercisable at a
price of $2.15 per share and have a five-year term. Certain of the
Companys principal stockholders, including affiliates of
certain of the Companys directors, purchased an aggregate of
approximately $24,300,000, or approximately 81%, of the Units
sold.
Share-Based Compensation
In June 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(the 1994 Plan), under which, as amended, 1,640,000 shares of common stock were authorized for
issuance. The 1994 Plan expired in June 2004 and there were 861,261 options outstanding under the
1994 Plan as of June 30, 2008.
7
In May 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the 2004 Plan), under which, as amended, 6,400,000 shares of common stock have been authorized
for issuance. The 2004 Plan provides for the grant of incentive and non-qualified stock options, as
well as other share-based payment awards, to employees, directors, consultants and advisors of the
Company with up to a 10-year contractual life and various vesting periods as determined by the
Companys Compensation Committee or the Board of Directors, as well as automatic fixed grants to
non-employee directors of the Company. As of June 30, 2008, there were a total of 4,803,533
options outstanding under the 2004 Plan and 1,317,248 shares remained available for future grant.
In August 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (the ESPP), under which, as amended, 850,000 shares of common stock are reserved
for sale to eligible employees, as defined in the ESPP. Employees may purchase common stock under
the ESPP every three months (up to but not exceeding 10% of each employees base salary or hourly
compensation, and any cash bonus paid, subject to certain limitations) over the offering period at
85% of the fair market value of the common stock at specified dates. The offering period may not
exceed 24 months. As of June 30, 2008, 609,329 shares of common stock have been issued under the
ESPP and 240,671 shares of common stock are available for future issuance.
Share-based compensation expense recognized under SFAS 123R for the three-month periods ended June
30, 2008 and 2007 was $1,172,000 and $1,463,000, respectively, and $2,289,000 and $2,579,000 for the
six-month periods ended June 30, 2008 and 2007, respectively. As of June 30, 2008, there was $6,854,000 of total
unrecognized compensation cost related to non-vested share-based payment awards granted under all
equity compensation plans. Total unrecognized compensation cost will be adjusted for future changes
in estimated forfeitures. The Company expects to recognize this compensation cost over a
weighted-average period of 1.4 years.
The following table summarizes share-based compensation expense related to employee and director
stock options, restricted stock and ESPP purchases under SFAS 123R by expense category:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
|
June 30, |
|
|
June 30, |
|
(in thousands) |
|
2008 |
|
|
2007 |
|
|
2008 |
|
|
2007 |
|
Research and development |
|
$ |
536 |
|
|
$ |
755 |
|
|
$ |
1,001 |
|
|
$ |
1,182 |
|
General and administrative |
|
|
636 |
|
|
|
708 |
|
|
|
1,288 |
|
|
|
1,397 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
expense included in
operating expenses |
|
$ |
1,172 |
|
|
$ |
1,463 |
|
|
$ |
2,289 |
|
|
$ |
2,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company determines the fair value of share-based payment awards on the date of grant using the
Black-Scholes option-pricing model, which is affected by the Companys stock price as well as
assumptions regarding a number of highly complex and subjective variables. Option-pricing models
were developed for use in estimating the value of traded options that have no vesting or hedging
restrictions and are fully transferable. Although the fair value of the employee and director stock
options granted by the Company is determined in accordance with SFAS 123R using an option-pricing
model, that value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
8
The Company estimated the fair value of each option grant and ESPP purchase right on the date of
grant using the Black-Scholes option-pricing model with the following weighted-average assumptions:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
Options: |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Risk-free interest rate |
|
|
3.3 |
% |
|
|
4.8 |
% |
|
|
3.1 |
% |
|
|
4.7 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
126.2 |
% |
|
|
109.4 |
% |
|
|
116.8 |
% |
|
|
119.6 |
% |
Expected life (years) |
|
|
5.6 |
|
|
|
5.9 |
|
|
|
5.6 |
|
|
|
6.0 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
Six Months Ended |
|
|
June 30, |
|
June 30, |
ESPP: |
|
2008 |
|
2007 |
|
2008 |
|
2007 |
Risk-free interest rate |
|
|
1.7 |
% |
|
|
4.9 |
% |
|
|
1.9 |
% |
|
|
5.0 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
67.5 |
% |
|
|
67.9 |
% |
|
|
79.4 |
% |
|
|
87.6 |
% |
Expected life (months) |
|
|
3.0 |
|
|
|
3.0 |
|
|
|
3.0 |
|
|
|
3.0 |
|
The weighted-average fair values of options granted were $1.60 and $4.76 for the three months ended
June 30, 2008 and 2007, respectively, and $1.80 and $3.73 for the six months ended June 30, 2008
and 2007, respectively. For the ESPP, the weighted-average purchase prices were $1.70 and $2.74
for the three months ended June 30, 2008 and 2007, respectively, and $1.69 and $2.66 for the six
months ended June 30, 2008 and 2007, respectively.
Expenses
allocable to options or stock awards issued to non-employees, other
than non-employee directors, have been determined in accordance with
EITF Issue No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or
in Conjunction with Selling, Goods or Services. Options granted
to such non-employees are periodically remeasured as options vest.
A summary of the Companys stock option activity and related data for the six months ended June 30,
2008 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
Number of |
|
Exercise |
|
|
Shares |
|
Price |
Balance at December 31, 2007 |
|
|
4,809,575 |
|
|
$ |
8.56 |
|
Granted |
|
|
1,231,900 |
|
|
$ |
2.15 |
|
Exercised |
|
|
(1,097 |
) |
|
$ |
2.51 |
|
Forfeited or expired |
|
|
(375,584 |
) |
|
$ |
9.09 |
|
|
|
|
|
|
Balance at June 30, 2008 |
|
|
5,664,794 |
|
|
$ |
7.13 |
|
|
|
|
|
|
6. Income Taxes
On July 13, 2006, the 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
prescribes a recognition threshold and measurement attributes for financial statement disclosure of
tax positions taken or expected to be taken in a tax return. Under FIN 48, the impact of an
uncertain income tax position on the income tax return must be recognized at the largest amount
that is more-likely-than-not to be sustained upon audit by the relevant taxing authority. An
uncertain income tax position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides guidance on derecognition, classification, interest and
penalties, accounting in interim periods, disclosure and transition. FIN 48 is effective for fiscal
years beginning after December 15, 2006. The Company adopted the provisions of FIN 48 on January 1,
2007. There were no unrecognized tax benefits as of the date of adoption and there are no
unrecognized tax benefits included in the condensed consolidated balance sheet at June 30, 2008,
that would, if recognized, affect the effective tax rate.
9
The Companys practice is to recognize interest and/or penalties related to income tax matters in
income
tax expense. The Company had no accrual for interest or penalties on the Companys condensed
consolidated balance sheets at June 30, 2008 and at December 31, 2007, and has not recognized
interest and/or penalties in the unaudited condensed consolidated statement of operations for the
three and six months ended June 30, 2008 and 2007.
The Company is subject to taxation in the United States and various state jurisdictions. The
Companys tax years for 1993 and forward are subject to examination by the United States and
California tax authorities due to the carry forward of unutilized net operating losses and research
and development credits.
The Company is currently undergoing an analysis under Section 382/383 of the Internal Revenue Code,
regarding the limitation of net operating loss and research and development credit carryforwards.
When this analysis is finalized, the Company plans to update its unrecognized tax benefits under
FIN No. 48. The Company expects the Section 382 analysis to be completed within the next twelve
months. Due to the existence of the valuation allowance, future changes in the Companys
unrecognized tax benefits will not impact the Companys effective tax rate.
ITEM 2. MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Forward-Looking Statements
The forward-looking statements in this report involve significant risks, assumptions and
uncertainties, and a number of factors, both foreseen and unforeseen, could cause actual results to
differ materially from our current expectations. Forward-looking statements include those that
express a plan, belief, expectation, estimation, anticipation, intent, contingency, future
development or similar expression. The analyses of clinical results of Riquent®
(abetimus sodium), 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 any other country, 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 ability to develop and sell our products in the future may be adversely affected by the
intellectual property rights of third parties or the validity or enforceability of our intellectual
property rights. Additional risk factors include the uncertainty and timing of: our ability to
raise additional capital; our ability to liquidate our auction rate securities; obtaining required
regulatory approvals, including delays associated with any approvals that we may obtain; the timely
supply of drug product for clinical trials; our ability to pass all necessary regulatory
inspections; 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. Accordingly, you
should not rely upon forward-looking statements as predictions of future events. The outcome of
the events described in these forward-looking statements are subject to the risks, uncertainties
and other factors described in the Risk Factors contained in our Annual Report on Form 10-K for
the year ended December 31, 2007, Quarterly Report on Form 10-Q for the period ended March 31, 2008
and in other reports and registration statements that we file with the Securities and Exchange
Commission from time to time. We expressly disclaim any intent to update forward-looking
statements.
10
Developments in 2008
On February 11, 2008, we announced that we had made significant progress in our current
double-blind, placebo-controlled randomized Phase 3 clinical study of Riquent, referred to as the
Phase 3 ASPEN study (Abetimus Sodium in Patients with a History of Lupus Nephritis) in that we
had enrolled 607 patients and 130 clinical trial sites were open to enroll patients in 23
countries.
On April 23, 2008, we announced the following information related to our current Phase 3 ASPEN
study:
|
|
|
Positive 12-month interim antibody data analyses of 12-month interim antibody data
in the first 125 patients randomized in the study indicate that for all patients
treated with 900 mg, 300 mg, or 100 mg of Riquent per week compared with placebo, there
were significantly greater reductions in antibodies to double-stranded DNA (p <
0.0001); |
|
|
|
|
Interim efficacy analyses two interim efficacy analyses are planned, each with
target p values of p < 0.001 and a final p value of p < 0.05 at the end of the
study. A futility analysis has been added to each interim efficacy analysis. The
first analysis is expected to occur around the fourth quarter of 2008 and the second is
expected to occur about midway between the first analysis and the expected end of the
study; |
|
|
|
|
Progression of the trial more than 140 sites are active and more than 670 patients
have been enrolled; |
|
|
|
|
Extension of treatment period the treatment period has been extended beyond 12
months until the required number of renal flares is achieved, which is 128 renal
flares. |
|
|
|
|
Increase in patient enrollment we now estimate that at least 800 patients will be
enrolled in the study and that the trial should be completed in the second half of
2009; and |
|
|
|
|
Independent Data Monitoring Board (DMB) review
the DMB has completed three
reviews of the safety data and has not indicated any safety issues. |
On May 12, 2008, we sold 15.6 million Units (the Units, where each Unit consists of one
share of common stock, $0.01 par value per share and a warrant to purchase 0.25 shares of Common
Stock) in an underwritten public offering at a price per Unit of $1.92125, for net proceeds
totalling approximately $28.1 million. The warrants, which represent the right to acquire a total
of 3.9 million shares of common stock, will be exercisable at a price of $2.15 per share and have a
five-year term. Certain of our principal stockholders, including
affiliates of certain of our directors, purchased an aggregate of
approximately $24.3 million, or approximately 81%, of the Units
sold.
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 are conducting and expanding 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 an event-driven trial
requiring us to accrue a specified number of renal flares to complete the study. We currently
target enrolling at least 800 patients to achieve the required number of renal flares and the trial
could 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 other drug candidates. We will need additional funds to finance our future
11
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 that we may
establish, if any. Some of these fluctuations may be significant. As of June 30, 2008, our
accumulated deficit was approximately $381.4 million.
Our business is subject to significant risks, including, but not limited to, the need for
additional financing or a collaborative partner to continue our clinical activities and continue to
operate, 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.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with United States generally accepted accounting principles (GAAP). The preparation of these
consolidated financial statements requires us to make estimates and judgments that affect the
reported amounts of assets, liabilities, revenues and expenses, and related disclosure of
contingent assets and liabilities. We evaluate our estimates on an ongoing basis, including those
related to patent costs, clinical/regulatory expenses and, effective January 1, 2008, the fair
value of our financial instruments. We base our estimates on historical experience and on other
assumptions that we believe to be reasonable under the circumstances, the results of which form the
basis for making judgments about the carrying values of assets and liabilities that are not readily
apparent from other sources. Actual results may differ materially from these estimates under
different assumptions or conditions.
We believe the following critical accounting policies involve significant judgments and
estimates used in the preparation of our condensed consolidated financial statements (see also Note
1 to our unaudited condensed consolidated financial statements included in Part I).
Impairment and useful lives of long-lived assets
We regularly review our long-lived assets for impairment. Our long-lived assets include costs
incurred to file our patent applications. We evaluate the recoverability of long-lived assets by
measuring the carrying amount of the assets against the estimated undiscounted future cash flows
associated with them. At the time such evaluations indicate that the future undiscounted cash flows
of certain long-lived assets are not sufficient to recover the carrying value of such assets, the
assets are adjusted to their fair values. The estimation of the undiscounted future cash flows
associated with long-lived assets requires judgment and assumptions that could differ materially
from the actual results. While we believe our current and historical operating and cash flow losses
are indicators of impairment, we believe the future cash flows to be received from the long-lived
assets will exceed the assets carrying value. There were no impairment losses recognized on our
long-lived assets for the six-month periods ended June 30, 2008 and 2007.
Costs related to successful patent applications are amortized using the straight-line method
over the lesser of the remaining useful life of the related technology or the remaining patent
life, commencing on the date the patent is issued. Legal costs and expenses incurred in connection
with pending patent applications have been capitalized. We expense all costs related to abandoned
patent applications. If we
12
elect to abandon any of our currently issued or unissued patents, the
related expense could be material to our results of operations for the period of abandonment. The
estimation of useful lives for long-lived
assets requires judgment and assumptions that could differ materially from the actual results.
In addition, our results of operations could be materially impacted if we begin amortizing the
costs related to unissued patents.
Accrued clinical/regulatory expenses
We review and accrue clinical trial and regulatory-related expenses based on work performed,
which relies on estimates of total costs incurred based on patient enrollment, sites activated and
other events. We follow this method because reasonably dependable estimates of the costs applicable
to various stages of a clinical trial can be made. Accrued clinical/regulatory costs are subject to
revisions as trials progress to completion. Revisions are charged to expense in the period in which
the facts that give rise to the revision become known. Historically, revisions have not resulted in
material changes to research and development costs; however a modification in the protocol of a
clinical trial or cancellation of a trial could result in a charge to our results of operations.
Share-Based Compensation
We adopted Statement of Financial Accounting Standard (SFAS) No. 123R, Share-Based Payments
(SFAS 123R) using the modified prospective transition method, which requires the application of
the accounting standard as of January 1, 2006. Share-based compensation expense recognized under
SFAS 123R was approximately $2.3 million and $2.6 million for the six-month periods ended June 30,
2008 and 2007, respectively. As of June 30, 2008, there was approximately $6.9 million of total
unrecognized compensation cost related to non-vested share-based payment awards granted under all
equity compensation plans. Total unrecognized compensation cost will be adjusted for future changes
in estimated forfeitures. We currently expect to recognize the remaining unrecognized compensation
cost over a weighted-average period of 1.4 years. Additional share-based compensation expense for
any new share-based payment awards granted after June 30, 2008 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.
Option-pricing models were developed for use in estimating the value of traded options that
have no vesting or hedging restrictions and are fully transferable. Because the employee and
director stock options granted by us have characteristics that are significantly different from
traded options, and because changes in the subjective assumptions can materially affect the
estimated value, in our opinion the existing valuation models may not provide an accurate measure
of the fair value of the employee and director stock options granted by us. Although the fair value
of the employee and director stock options granted by us is determined in accordance with SFAS 123R
using an option-pricing model, that value may not be indicative of the fair value observed in a
willing-buyer/willing-seller market transaction.
Fair Value of Financial Instruments
Effective January 1, 2008, we adopted SFAS No. 157, Fair Value Measurements. In February 2008,
the Financial Accounting Standards Board (FASB) issued FASB Staff Position (FSP) No. SFAS
157-2, Effective Date of FASB Statement No. 157, which provides a one year deferral of the
effective date of SFAS No. 157 for non-financial assets and non-financial liabilities, except those
that are recognized or disclosed in the financial statements at fair value at least annually.
Therefore, we have adopted the provisions of SFAS 157 with respect to financial assets and
liabilities only.
SFAS 157 defines fair value, establishes a framework for measuring fair value under GAAP and
enhances disclosures about fair value measurements. Fair value is defined under SFAS 157 as the
exchange price that would be received for an asset or paid to transfer a liability (an exit price)
in the principal or most advantageous market for the asset or liability in an orderly transaction
between market participants on the measurement date. Valuation techniques used to measure fair
value under SFAS 157 must maximize the use of observable inputs and minimize the use of
unobservable inputs. The standard describes a fair value hierarchy based on three levels of inputs,
of which the first two are considered observable and the last unobservable, that may be used to
measure fair value which are the following:
13
|
|
Level 1 Quoted prices in active markets for identical assets or liabilities. |
|
|
|
Level 2 Inputs other than Level 1 that are observable, either directly or
indirectly, such as quoted prices for similar assets or liabilities; quoted
prices in markets that are not active; or other inputs that are observable or
can be corroborated by observable market data for substantially the full term
of the assets or liabilities. |
|
|
|
Level 3 Unobservable inputs that are supported by little or no market
activity and that are significant to the fair value of the assets or
liabilities. |
The adoption of this statement impacted our calculation of fair value associated with our
investments, specifically our auction rate securities, which became illiquid during the first
quarter of 2008. In accordance with SFAS 157, we valued these securities using Level 3
hierarchical inputs due to the lack of actively traded market data. These inputs include
managements assumptions of pricing by market participants, including assumptions about risk. We
based our fair value determination on estimated discounted future cash flows of interest income
over a projected period reflective of the length of time the Company anticipates it will take the
securities to become liquid. We considered any impairment on these investments to be
other-than-temporary, thus any changes in fair value were recorded to the unaudited condensed
consolidated statement of operations for the three and six months ended June 30, 2008. Because we
were required to value those securities using only Level 3 inputs, our valuation determinations are
somewhat subjective and the actual fair values as determined at a later date or by a third party
may be different than the fair values we have determined.
Recent Accounting Pronouncements
On January 1, 2008, we adopted the provisions of 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.
See Note 3 for further details on the impact of the adoption of SFAS 157 on our unaudited condensed
consolidated results of operations and financial condition for the three and six months ended June
30, 2008.
On January 1, 2008, we adopted the provisions of FASB SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities Including an amendment of FASB Statement No. 115
(SFAS 159). SFAS 159 permits entities to choose to measure many financial assets and financial
liabilities at fair value. Unrealized gains and losses on items for which the fair value option has
been elected are reported in earnings. At this time, we have not elected to account for any of our
financial assets or liabilities using the provisions of SFAS 159. As such, the adoption of SFAS
159 did not have an impact on our unaudited condensed consolidated results of operations and
financial condition for the three and six months ended June 30, 2008.
In June 2007, FASB ratified the consensus reached by the Emerging Issues Task Force (EITF)
on EITF Issue No. 07-3, Accounting for Nonrefundable Advance Payments for Goods or Services to Be
Used in Future Research and Development Activities (EITF 07-3). EITF 07-3 addresses the diversity
that exists with respect to the accounting for the non-refundable portion of a payment made by a
research and development entity for future research and development activities. Under EITF 07-3, an
entity would defer and capitalize non-refundable advance payments made for research and development
activities until the related goods are delivered or the related services are performed. EITF 07-3
is effective for fiscal years beginning after December 15, 2007. On January 1, 2008 we adopted the
provisions of EITF 07-3, which did not have an impact on our unaudited condensed consolidated
results of operations and financial condition for the three and six months ended June 30, 2008.
14
Results of Operations
For the three and six months ended June 30, 2008, research and development expenses increased
to $12.7 million and $24.1 million, respectively, from $12.2 million and $22.6 million,
respectively, for the same periods in 2007. Due to expansion of the Phase 3 clinical trial of
Riquent®, shipping costs for drug and lab specimens and fees for clinical research
organizations, investigators and labs increased by approximately $5.0 million for the six months
ended June 30, 2008 as compared to the same period in 2007. This increase in expenses was offset
against a reduction of approximately $3.3 million for expenses associated with the manufacture of
Riquent® for the six months ended June 30, 2008 as compared to the same period in 2007.
Adequate supplies of Riquent® were on hand for the first six months of 2008, thereby
reducing manufacturing expenses incurred for this period.
We expect that our research and development expense will increase significantly in the future
as our Phase 3 trial continues to expand. For example, our 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, is expected to involve at least 800 patients and take several years
to complete. As patient 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.
General and administrative expense for the three months ended June 30, 2008 and 2007 remained
constant at $2.1 million. For the six months ended June 30, 2008 and 2007, general and
administrative expense slightly decreased to $4.0 million from $4.1 million. 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 of interest expense, decreased to $0.1 million for the three months ended
June 30, 2008 from $0.8 million for the same period in 2007 and decreased to $0.4 million for the
six months ended June 30, 2008 from $1.3 million for the same period in 2007. The decreases for
the three and six months ended June 30, 2008 were due primarily to lower average balances of cash,
cash equivalents and short-term investments and lower average interest rates as compared to the
same periods in 2007.
Realized loss on investments, net, of $0.2 million and $1.0 million for the three and six
months ended June 30, 2008, respectively, consisted of the other-than-temporary impairment loss on
our auction rate securities recorded in 2008, in connection with the adoption of SFAS 157. See
Note 3 to our unaudited condensed consolidated financial statements for further details.
Liquidity and Capital Resources
From inception through June 30, 2008, we have incurred a cumulative net loss of approximately
$381.4 million and have financed our operations through public and private offerings of securities,
revenues from collaborative agreements, equipment financings and interest income on invested cash
balances. From inception through June 30, 2008, we have raised approximately $403.9 million in net
proceeds from sales of equity securities.
On May 12, 2008, we sold 15.6 million Units (the Units, where each Unit consists of one
share of common stock, $0.01 par value per share and a warrant to purchase 0.25 shares of Common
Stock) in an underwritten public offering at a price per Unit of $1.92125, for net proceeds
totalling approximately $28.1 million. The warrants, which represent the right to acquire a total
of 3.9 million shares of common stock, will be exercisable at a price of $2.15 per share and have a
five-year term. Certain of our principal stockholders, including
affiliates of certain of our directors, purchased an aggregate of
approximately $24.3 million, or approximately 81%, of the Units
sold.
At June 30, 2008, we had $40.7 million in cash, cash equivalents and short-term investments,
as compared to $39.4 million at December 31, 2007. Our working capital at June 30, 2008 was $31.8
million, as compared to $29.9 million at December 31, 2007. The increase in cash, cash equivalents
and
15
short-term investments resulted from the net proceeds of $28.1 million from the sale of 15.6
million Units, offest by our use of financial resources to fund our clinical trial and
manufacturing activities and for other general corporate purposes as well as the $1.0 million
realized impairment loss on our auction rate securities recorded in 2008. We invest our cash in
money market funds and AAA rated asset-backed student loan auction rate securities. As of June 30,
2008, we classified all of our student loan auction rate securities as short-term
available-for-sale securities as we will need additional cash in the near term and may be required
to liquidate these auction rate securities in order to continue our operations. In the event we
need to access the funds that are in an illiquid state, we will not be able to do so without a loss
of principal until a future auction on these auction rate securities is successful or the
securities are redeemed by the issuer at par. As a result, we have recorded a realized impairment
loss on investments in 2008 of approximately $1.0 million. As of June 30, 2008, all of our
short-term available-for-sale securities have stated maturity dates of more than one year, however,
their interest rates are reset periodically within time periods not exceeding 92 days.
As of June 30, 2008, approximately $0.7 million of equipment ($0.4 million net of
depreciation) is financed under notes payable and capital lease obligations. We lease our office
and laboratory facilities and certain equipment under operating leases. We have also entered into
non-cancelable purchase commitments for an aggregate of $1.3 million with third-party manufacturers
of materials to be used in the production of Riquent, approximately $0.5 million of which is
included in the unaudited condensed consolidated balance sheet as of June 30, 2008. 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 June 30, 2008 (in thousands).
Long-term debt and capital lease obligations include interest.
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|
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|
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|
Payment due by period |
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
More than |
|
|
Total |
|
1 Year |
|
1-3 Years |
|
3-5 Years |
|
5 Years |
Long-Term Debt Obligations |
|
$ |
470 |
|
|
$ |
177 |
|
|
$ |
293 |
|
|
$ |
|
|
|
$ |
|
|
Capital Lease Obligations |
|
|
61 |
|
|
|
14 |
|
|
|
42 |
|
|
|
5 |
|
|
|
|
|
Operating Lease Obligations |
|
|
1,036 |
|
|
|
846 |
|
|
|
180 |
|
|
|
10 |
|
|
|
|
|
Purchase Obligations |
|
|
1,258 |
|
|
|
1,258 |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,825 |
|
|
$ |
2,295 |
|
|
$ |
515 |
|
|
$ |
15 |
|
|
$ |
|
|
|
|
|
|
|
|
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|
We intend to use our financial resources to fund the current clinical studies 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 results from current
and future clinical trials, the continued analysis of the clinical trial data of Riquent, the
outcome of our meetings with regulatory authorities, the timing of any regulatory applications and
approvals, 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 liquid cash resources, consisting of cash and cash
equivalents, and the interest earned thereon, will be sufficient to fund our operations as
currently planned through December 31, 2008. This projection is based on the assumption that we do
not raise any additional funds, including through the sale of additional securities, obtaining debt
financing or establishing a collaborative agreement with a corporate partner, we cannot liquidate
our auction rate securities, and that we do not engage in any significant commercialization
activities or significant activities in our other research programs.
We will continue to seek capital through any number of means, including by issuing our equity
securities, obtaining debt finacing 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 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.
16
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.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current
or future effect on our consolidated financial condition, changes in our consolidated financial
condition, expenses, consolidated results of operations, liquidity, capital expenditures or capital
resources.
ITEM 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. We currently do not invest in any securities that are
materially and directly affected by foreign currency exchange rates or commodity prices.
All of our investment securities are classified as available-for-sale and are therefore
reported on the balance sheet at market value. Our investment securities consist of money market
funds and asset-backed student loan auction rate securities. As of June 30, 2008, our short-term
investments consisted of $9.0 million (net of a realized impairment loss of $1.0 million) of AAA
rated student loan auction rate securities. Our auction rate securities are debt instruments with
long-term maturities and interest rates that reset in short intervals through auctions.
The recent conditions in the global credit markets have prevented some investors from
liquidating their holdings of auction rate securities because the amount of securities submitted
for sale has exceeded the amount of purchase orders for such securities. If there is insufficient
demand for the securities at the time of an auction, the auction may not be completed and the
interest rates may be reset to the securitys predetermined rate. When auctions for these
securities fail, the investments may not be readily convertible to cash until a future auction of
these investments is successful or they are redeemed or mature, which could be many years. If the
credit ratings of the security issuers deteriorate and any decline in market value is determined to
be other-than-temporary, the carrying value of the investment would be required to be adjusted
through an impairment charge.
As of June 30, 2008, there was insufficient demand at auctions for all four of our AAA rated
asset-backed student loan auction rate securities. As a result of this insufficient demand, these
four securities are currently not liquid and the interest rates have been reset to the securitys
predetermined interest rate. To date, we have recognized a realized impairment loss of $1.0 million
on these securities. See Note 3 to our unaudited condensed consolidated financial statements for
further information.
In the event we need to access the funds that are in an illiquid state, we will not be able to
do so without the possible loss of principal, until a future auction for these investments is
successful or they are redeemed by the issuer at par. At this time the market for these investments
is presently uncertain. If we are unable to sell these securities in the market or they are not
redeemed, this could potentially impact our current business plan as we will need the ability to
access these funds in the near future.
17
ITEM 4. CONTROLS AND PROCEDURES
Our management, with the participation of our principal executive officer and principal
financial
officer, evaluated the effectiveness of our disclosure controls and procedures as of June 30,
2008. The term disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e)
under the Securities Exchange Act of 1934, as amended (Exchange Act), means controls and other
procedures of a company that are designed to ensure that information required to be disclosed by a
company in the reports that it files or submits under the Exchange Act is recorded, processed,
summarized and reported, within the time periods specified in the Securities and Exchange
Commissions rules and forms. Disclosure controls and procedures include, without limitation,
controls and procedures designed to ensure that information required to be disclosed by a company
in the reports that it files or submits under the Exchange Act is accumulated and communicated to
the companys management, including its principal executive and principal financial officers, as
appropriate to allow timely decisions regarding required disclosure. Management recognizes that any
controls and procedures, no matter how well designed and operated, can provide only reasonable
assurance of achieving their objectives and management necessarily applies its judgment in
evaluating the cost-benefit relationship of possible controls and procedures. Based on the
evaluation of our disclosure controls and procedures as of June 30, 2008, our principal executive
officer and principal financial officer concluded that, as of such date, the Companys disclosure
controls and procedures were effective at the reasonable assurance level.
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and
15d-15(f) under the Exchange Act) occurred during the quarter ended June 30, 2008 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
ITEM 1. RISK FACTORS
No material changes to risk factors as previously disclosed in our Annual Report on Form 10-K
for the year ended December 31, 2007 have occurred, other than those set forth in our Quarterly
Report on Form 10-Q for the quarter ended March 31, 2008.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Our Annual Meeting of Stockholders was held on May 22, 2008. All of the directors nominated
for election by our board of directors, as set forth in our proxy statement, were elected as
follows:
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|
|
Director Nominee |
|
Term |
|
Votes in Favor |
|
Votes Withheld |
Robert A. Fildes |
|
Three years |
|
|
36,241,495 |
|
|
|
606,530 |
|
Martin P. Sutter |
|
Three years |
|
|
36,250,215 |
|
|
|
597,810 |
|
James N. Topper |
|
Three years |
|
|
36,269,271 |
|
|
|
578,754 |
|
In addition, Thomas H. Adams, Deirdre Y. Gillespie, Craig R. Smith, Stephen M. Martin, and
Frank E. Young continued to serve on our board of directors after the Annual Meeting. All of our
proposals, as set forth in our proxy statement, were approved as follows:
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|
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|
|
Broker |
Proposal Description |
|
Votes in Favor |
|
Votes Against |
|
Abstaining |
|
Non-Votes |
Amendment to the La
Jolla
Pharmaceutical
Company 2004 Equity
Incentive Plan to
increase the number
of shares of common
stock available
under the plan by
1,400,000 shares |
|
26,915,247 |
|
|
463,791 |
|
|
|
29,410 |
|
|
|
9,439,578 |
|
18
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|
|
|
|
|
|
|
|
|
|
|
|
Broker |
Proposal Description |
|
Votes in Favor |
|
Votes Against |
|
Abstaining |
|
Non-Votes |
Amendment to the La
Jolla
Pharmaceutical
Company 1995
Employee Stock
Purchase Plan to
increase the number
of shares of common
stock available
under the plan by 150,000 |
|
27,042,821 |
|
|
342,792 |
|
|
|
22,835 |
|
|
|
9,439,578 |
|
Ratification of the
appointment of
Ernst & Young LLP
as our independent
registered public
accounting firm for
the fiscal year
ending December 31,
2008 |
|
36,677,499 |
|
|
140,565 |
|
|
|
29,961 |
|
|
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|
ITEM 6. EXHIBITS
|
|
|
Exhibit |
|
|
Number |
|
Description |
|
|
|
3.1
|
|
Restated Certificate of Incorporation (1) |
|
|
|
3.2
|
|
Amended and Restated Bylaws (2) |
|
|
|
4.1
|
|
Rights Agreement, dated as of December 3, 1998, between the Company
and American Stock Transfer & Trust Company (3) |
|
|
|
4.2
|
|
Amendment No. 1 to the Rights Agreement, dated as of July 21, 2000,
between the Company and American Stock Transfer & Trust Company (4) |
|
|
|
4.3
|
|
Amendment No. 2 to the Rights Agreement, dated as of December 14,
2005, between the Company and American Stock Transfer & Trust Company
(5) |
|
|
|
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) |
|
|
|
4.5
|
|
Amendment No. 4, effective May 12, 2008, to Rights Agreement dated
December 3, 1998, as amended, by and between La Jolla Pharmaceutical
Company and American Stock Transfer & Trust Company, including the
Summary of Rights to be distributed to stockholders (6) |
|
|
|
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 |
|
|
|
(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 8-A (Registration No.
000-24274) filed December 4, 1998 and incorporated by reference herein. |
|
(4) |
|
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. |
|
(5) |
|
Previously filed with the Companys Current Report on Form 8-K filed December 16, 2005 and
incorporated by reference herein. |
|
(6) |
|
Previously filed with the Companys Current Report on Form 8-K filed May 12, 2008 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: August 8, 2008 |
/s/ Deirdre Y. Gillespie
|
|
|
Deirdre Y. Gillespie, M.D. |
|
|
President and Chief Executive Officer
(On behalf of the Registrant) |
|
|
|
|
|
|
|
|
/s/ Niv E. Caviar
|
|
|
Niv E. Caviar |
|
|
Executive Vice President, Chief
Business Officer
and Chief Financial Officer
(As Principal Financial Officer) |
|
|
|
|
|
|
|
|
/s/ Gail A. Sloan
|
|
|
Gail A. Sloan |
|
|
Vice President of Finance and
Secretary
(As Principal Accounting Officer) |
|
|
20
LA JOLLA PHARMACEUTICAL COMPANY
INDEX TO EXHIBITS
|
|
|
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 |