La Jolla Pharmaceutical Company
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, 2007
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, $0.01 par value per share, outstanding at
November 1, 2007 was 39,606,515.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
ITEM 1. CONDENSED FINANCIAL STATEMENTS UNAUDITED
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands)
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September 30, |
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December 31, |
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2007 |
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2006 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,169 |
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$ |
3,829 |
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Short-term investments |
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44,902 |
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39,080 |
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Prepaids and other current assets |
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953 |
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1,004 |
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Total current assets |
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51,024 |
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43,913 |
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Property and equipment, net |
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1,304 |
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2,333 |
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Patent costs and other assets, net |
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3,033 |
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3,279 |
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Total assets |
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$ |
55,361 |
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$ |
49,525 |
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LIABILITIES AND STOCKHOLDERS EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
1,866 |
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$ |
2,125 |
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Accrued clinical/regulatory expenses |
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3,932 |
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1,530 |
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Accrued expenses |
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1,516 |
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1,137 |
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Accrued payroll and related expenses |
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1,011 |
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1,265 |
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Current portion of obligations under notes payable |
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95 |
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183 |
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Total current liabilities |
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8,420 |
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6,240 |
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Noncurrent portion of obligations under notes payable |
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186 |
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196 |
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Commitments |
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Stockholders equity: |
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Common stock |
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396 |
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327 |
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Additional paid-in capital |
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384,775 |
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342,519 |
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Other comprehensive income |
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17 |
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Accumulated deficit |
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(338,433 |
) |
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(299,757 |
) |
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Total stockholders equity |
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46,755 |
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43,089 |
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Total liabilities and stockholders equity |
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$ |
55,361 |
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$ |
49,525 |
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Note: The condensed consolidated balance sheet at December 31, 2006 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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Nine Months Ended |
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September 30, |
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September 30, |
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2007 |
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2006 |
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2007 |
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2006 |
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Expenses: |
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Research and development |
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$ |
11,448 |
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$ |
7,687 |
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$ |
34,009 |
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$ |
23,764 |
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General and administrative |
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2,585 |
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1,546 |
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6,677 |
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7,171 |
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Total expenses |
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14,033 |
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9,233 |
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40,686 |
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30,935 |
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Loss from operations |
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(14,033 |
) |
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(9,233 |
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(40,686 |
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(30,935 |
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Interest income |
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752 |
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701 |
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2,084 |
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2,211 |
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Interest expense |
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(8 |
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(6 |
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(74 |
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(27 |
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Net loss |
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$ |
(13,289 |
) |
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$ |
(8,538 |
) |
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$ |
(38,676 |
) |
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$ |
(28,751 |
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Basic and diluted net loss per share |
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$ |
(0.34 |
) |
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$ |
(0.26 |
) |
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$ |
(1.04 |
) |
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$ |
(0.88 |
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Shares used in computing basic and
diluted net loss per share |
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39,577 |
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32,534 |
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37,215 |
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32,510 |
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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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2007 |
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2006 |
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Operating activities: |
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Net loss |
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$ |
(38,676 |
) |
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$ |
(28,751 |
) |
Adjustments to reconcile net loss to net cash used for operating
activities: |
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Depreciation and amortization |
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1,300 |
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1,507 |
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Loss on write-off/disposal of patents and property and equipment |
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691 |
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172 |
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Share-based compensation expense |
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3,715 |
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4,170 |
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Accretion of interest income, net |
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(140 |
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46 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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51 |
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(177 |
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Accounts payable |
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(259 |
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749 |
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Accrued clinical/regulatory expenses |
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2,402 |
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560 |
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Accrued expenses |
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379 |
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149 |
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Accrued payroll and related expenses |
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(254 |
) |
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(163 |
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Net cash used for operating activities |
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(30,791 |
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(21,738 |
) |
Investing activities: |
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Purchases of short-term investments |
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(47,415 |
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(16,700 |
) |
Sales of short-term investments |
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41,750 |
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40,050 |
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Additions to property and equipment |
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(117 |
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(316 |
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Increase in patent costs and other assets |
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(599 |
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(362 |
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Net cash (used for) provided by investing activities |
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(6,381 |
) |
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22,672 |
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Financing activities: |
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Net proceeds from issuance of common stock |
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38,610 |
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192 |
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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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(173 |
) |
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(451 |
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Net cash provided by (used for) financing activities |
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38,512 |
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(259 |
) |
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Net increase in cash and cash equivalents |
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1,340 |
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|
675 |
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Cash and cash equivalents at beginning of period |
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3,829 |
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6,411 |
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Cash and cash equivalents at end of period |
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$ |
5,169 |
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$ |
7,086 |
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Supplemental disclosure of cash flow information: |
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Interest paid |
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$ |
74 |
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$ |
27 |
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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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$ |
17 |
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$ |
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2007
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 severance
accrual see Note 3 for further details) considered necessary for a fair presentation have been
included. Operating results for the three and nine months ended September 30, 2007 are not
necessarily indicative of the results that may be expected for other quarters or the year ended
December 31, 2007. 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, 2006 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.
Recent Accounting Pronouncement
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 does not currently believe that the adoption of
SFAS 157 will have a material impact on its consolidated results of operations and financial
condition.
In February 2007, FASB issued 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. SFAS 159 is effective for fiscal years beginning after November 15, 2007. The
Company is currently assessing the impact of SFAS 159 on its consolidated results of operations and
financial condition.
4
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.
There were no unvested common shares subject to repurchase for the three and nine months ended
September 30, 2007. The number of weighted-average unvested common shares subject to repurchase
for the three and nine months ended September 30, 2006 were 64,398 and 61,724, respectively.
Comprehensive Loss
In accordance with SFAS No. 130, Reporting Comprehensive Income (Loss), unrealized gains and losses
on available-for-sale securities are included in other comprehensive income (loss). The Companys
comprehensive net loss totaled $13,272,000 and $8,538,000 for the three-month periods ended
September 30, 2007 and 2006, respectively, and $38,659,000 and $28,751,000 for the nine-month
periods ended September 30, 2007 and 2006, respectively.
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 was included in general and administrative expense. In accordance with the
separation agreement, the Company had paid $907,000 as of September 30, 2007.
4. Stockholders Equity
Share-Based Compensation
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 were authorized for
issuance. The 1994 Plan expired in June 2004 and there remained 956,535 options outstanding under
the 1994 Plan as of September 30, 2007.
In 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan (the
2004 Plan), under which, as amended, 5,000,000 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 September 30, 2007, there were a total of 3,837,038
options outstanding under the 2004 Plan and 884,796 shares remained available for future grant.
In 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock Purchase Plan
(the ESPP), under which, as amended, 700,000 shares of common stock are reserved for sale to
eligible employees, as defined in the ESPP. Employees may purchase common stock under the ESPP
5
every three months (up to but not exceeding 10% of each employees base salary or hourly
compensation, and any cash bonus paid) 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 September
30, 2007, 505,941 shares of common stock have been issued under the ESPP and 194,059 shares of
common stock are available for future issuance.
On January 1, 2006, the Company adopted SFAS No. 123 (revised 2004), Share-Based Payment (SFAS
123R). Under SFAS 123R, the estimated fair value of share-based compensation, including stock
options and restricted stock granted under the 2004 Plan and discounted purchases of common stock
by employees under the ESPP, is recognized as compensation expense. The estimated fair value of
stock options and restricted stock is expensed on a straight-line basis over the vesting term.
Compensation expense for purchases under the ESPP is recognized based on the estimated fair value
of the common stock for each quarterly purchase during the two-year offering period and the
purchase discount.
Expenses allocable to options or stock awards issued to non-employees, other than non-employee
directors, have been determined in accordance with Emerging Issues Task Force 96-18, Accounting for
Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with
Selling, Goods or Services. Deferred charges for options granted to such non-employees are
periodically remeasured as the options vest.
Share-based compensation expense recognized under SFAS 123R for the three-month periods ended
September 30, 2007 and 2006 was $1,134,000 and $1,142,000, respectively, and $3,713,000 and
$4,168,000, for the nine-month periods ended September 30, 2007 and 2006, respectively. As of
September 30, 2007 and 2006, there was $7,971,000 and $9,244,000, respectively, 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 1.2 years.
The following table summarizes share-based compensation expense related to employee and director
stock options, restricted stock and ESPP purchases under SFAS 123R by expense category (in
thousands):
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|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
Research and development |
|
$ |
378 |
|
|
$ |
446 |
|
|
$ |
1,560 |
|
|
$ |
1,590 |
|
General and administrative |
|
|
756 |
|
|
|
696 |
|
|
|
2,153 |
|
|
|
2,578 |
|
|
|
|
|
|
|
|
|
|
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|
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Share-based compensation
expense included in
operating expenses |
|
$ |
1,134 |
|
|
$ |
1,142 |
|
|
$ |
3,713 |
|
|
$ |
4,168 |
|
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|
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|
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|
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. Because 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 fair value of the 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.
6
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, |
|
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.7 |
% |
|
|
4.9 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
118.5 |
% |
|
|
113.9 |
% |
Expected life (years) |
|
|
5.5 - 6.1 |
|
|
|
5.5 - 6.1 |
|
|
|
|
|
|
|
|
|
|
ESPP: |
|
September 30, |
|
|
2007 |
|
2006 |
Risk-free interest rate |
|
|
4.8 |
% |
|
|
4.8 |
% |
Dividend yield |
|
|
0.0 |
% |
|
|
0.0 |
% |
Volatility |
|
|
72.1 |
% |
|
|
46.0 |
% |
Expected life |
|
3 months |
|
3 months |
The weighted-average fair values of options granted were $3.68 and $3.08 for the three months ended
September 30, 2007 and 2006, respectively, and $3.73 and $3.97 for the nine months ended September
30, 2007 and 2006, respectively. For the ESPP, the weighted-average purchase prices were $2.74 and
$3.07 for the three months ended September 30, 2007 and 2006, respectively, and $2.69 and $3.07 for
the nine months ended September 30, 2007 and 2006, respectively.
A summary of the Companys stock option activity and related data for the nine months ended
September 30, 2007 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
Average |
|
|
Number of |
|
Exercise |
|
|
Shares |
|
Price |
Balance at December 31, 2006 |
|
|
4,302,379 |
|
|
$ |
9.83 |
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
971,973 |
|
|
$ |
4.32 |
|
Exercised |
|
|
(165,922 |
) |
|
$ |
3.01 |
|
Forfeited or expired |
|
|
(314,857 |
) |
|
$ |
15.20 |
|
|
|
|
|
|
|
|
|
|
Balance at September 30, 2007 |
|
|
4,793,573 |
|
|
$ |
8.59 |
|
|
|
|
|
|
|
|
|
|
In March 2007, the Company awarded 3,600 shares of common stock to the Chairman of the Board in
accordance with the Chairman Compensation Policy approved by the Board of Directors on March 14,
2006 regarding the tax liability associated with the restricted stock issued on March 15, 2006 and
vested on March 15, 2007. The newly awarded shares immediately vested on the date of issuance, and
the Company recorded compensation expense of approximately $25,000 for the fair value of the award.
5. Income Taxes
On January 1, 2007, the Company adopted FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes An Interpretation of FASB Statement No. 109 (FIN 48), which clarifies the
accounting for uncertainty in income taxes recognized in an entitys financial statements in
accordance with SFAS 109. 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, disclosures and transition.
7
At January 1, 2007, the Company had net deferred tax assets of $131,496,000. The deferred tax
assets are primarily composed of federal and state tax net operating loss (NOL) carryforwards and
federal and state research and development (R&D) credit carryforwards. Due to uncertainties
surrounding the Companys ability to generate future taxable income to realize these assets, a full
valuation allowance has been established to offset the Companys net deferred tax assets.
Additionally, the future utilization of the Companys NOL and R&D credit carryforwards to offset
future taxable income may be subject to a substantial annual limitation under Section 382 of the
Internal Revenue Code due to ownership changes that have occurred previously or that could occur in
the future. The Company has not yet determined whether such an ownership change has occurred,
however, the Company plans to complete a Section 382 analysis regarding the limitation of the
carryforwards for NOL and R&D credits. When this project is completed, the Company plans to update
the unrecognized tax benefits under FIN 48. Therefore, the Company expects that the unrecognized
tax benefits may change within 12 months of this reporting date. At this time, the Company cannot
estimate how much the unrecognized tax benefits may change. Any carryforwards that will expire
prior to their utilization as a result of such limitations will be removed from deferred tax assets
with a corresponding reduction of the valuation allowance. Due to the existence of the valuation
allowance, future changes in the Companys unrecognized tax benefits will not impact the Companys
effective tax rate.
The Companys practice is to recognize interest and/or penalties related to income tax matters in
income tax expense. Upon adoption of FIN 48 on January 1, 2007, the Company did not record any
interest or penalties related to income tax matters.
The Company is subject to taxation in the U.S. and various state jurisdictions. The Companys tax
years are subject to examination for 1991 and forward by the U.S. tax authorities and for 1989 and
forward by the California tax authorities due to the carryforward of unutilized NOL and R&D
credits.
6. Changes in Securities
In April 2007, the Company sold an aggregate of 6,670,000 shares of common stock in a public
offering for net proceeds to the Company of approximately $37,911,000.
|
|
|
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, including the ability of the recently issued European composition of matter patent
to survive any opposition proceedings. Additional risk factors include the uncertainty and timing
of: obtaining required
8
regulatory approvals, including delays associated with any approvals that we may obtain; the
availability of sufficient financial resources; 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. 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.
Accordingly, you should not rely upon forward-looking statements as predictions of future events.
The outcome of the events described in these forward-looking statements are subject to the risks,
uncertainties and other factors described in Managements Discussion and Analysis of Financial
Condition and Results of Operations and elsewhere in this Quarterly Report on Form 10-Q, in the
Risk Factors contained in our Annual Report on Form 10-K for the year ended December 31, 2006,
and in other reports and registration statements that we file with the Securities and Exchange
Commission from time to time.
Developments in 2007
On February 1, 2007, we announced that we had made continued progress in enrolling patients in
our Phase 3 clinical trial of Riquent in that we had enrolled 202 patients in the study and 74
clinical trial sites were open to enroll patients, including newly added sites in Europe and
Mexico. In addition, we also announced that following recent discussions with the Food and Drug
Administration (FDA), we implemented several enhancements to further strengthen the current Phase 3
study, which remains under Special Protocol Assessment. These
enhancements include focus on higher doses and increase in sample
size.
On March 8 and March 20, 2007, we announced positive interim antibody results from our ongoing
double-blind, placebo-controlled randomized Phase 3 trial of Riquent. Analyses of interim antibody
data indicate that patients treated with 900 mg or 300 mg per week doses of Riquent had greater
reductions in antibodies to double-stranded DNA (dsDNA) than patients treated with 100 mg per
week or placebo. The results showed a significant dose response when comparing all Riquent-treated
patients to placebo-treated patients (p = 0.0001), and each Riquent dose group to the placebo dose
group (p < 0.0032 for 100 mg, p < 0.0001 for 300 mg and 900 mg).
On March 29, 2007, we announced the pricing of an underwritten public offering of 5,800,000
shares of our common stock at $6.00 per share. In connection with this offering, we granted the
underwriters an option to purchase up to an additional 870,000 shares to cover over-allotments. On
April 10, 2007, we announced that we had completed the public offering for total net proceeds of
approximately $37.9 million, including the proceeds from the over-allotment shares.
On April 26, 2007, we announced that composition of matter patents covering Riquent have
issued in both Europe and in the Peoples Republic of China. If the full five years of patent term
extension under a Supplemental Protection Certificate are granted, the term of the European patent
would extend to December 2, 2018. The Chinese patent will be in effect until September 8, 2014.
On May 10, 2007, we announced that Niv E. Caviar had joined the Company as Executive Vice
President, Chief Business Officer and Chief Financial Officer.
9
On May 24, 2007, we announced that we had presented three papers related to Riquent at the
8th International Congress on SLE. The first presentation reviewed recently announced safety
and interim antibody data from the current Phase 3 study which
highlighted the statistically
significant dose response observed between the 100 mg, 300 mg and 900 mg doses of Riquent compared
with placebo (p=0.0001). The second presentation reviewed the safety and drug levels of Riquent at
doses up to 2,400 mg in healthy volunteers and the third, cardiovascular safety in healthy
volunteers.
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 700 patients and take several years to complete. 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 $37.9 million from the fundraising that we completed in April 2007, we expect that we
will need additional funds to complete the Phase 3 trial and to continue the development of
Riquent. 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, 2007, our
accumulated deficit was approximately $338.4 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 and Estimates
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.
10
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 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. We have
expensed approximately $0.7 million for the nine months ended September 30, 2007 primarily for
the write-off of selected pending patent applications for technologies not related to Riquent or
our small molecule SSAO inhibitors that are no longer being pursued. There were no significant
patent write-offs recognized for the nine months ended September 30, 2006.
Recent Accounting Pronouncements
For information on the recent accounting pronouncements impacting our business, see Note 2 of
the notes to condensed consolidated financial statements included in Item 1.
Results of Operations
For the three and nine months ended September 30, 2007, research and development expenses
increased to $11.4 million and $34.0 million, respectively, from $7.7 million and $23.8 million,
respectively, for the same periods in 2006. These increases were primarily attributable to
increased activity in the Phase 3 clinical trial of Riquent.
Research and development expenses of $11.4 million and $34.0 million for the three and nine
months ended September 30, 2007, respectively, consisted primarily of costs related to the Phase 3
clinical trial of Riquent, including fees for clinical research organizations, labs, investigators,
drug production costs and salaries for manufacturing, clinical and research personnel, as well as
share-based compensation expense of approximately $0.4 million and $1.6 million, respectively.
We expect that our research and development expense will increase significantly in the future.
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 approximately 700 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.
For the three months ended September 30, 2007, general and administrative expense increased to
$2.6 million from $1.5 million for the same period in 2006 and decreased to $6.7 million for the
nine months ended September 30, 2007, from $7.2 million for the same period in 2006. The increase
for the three months ended September 30, 2007 was primarily due to the write-off of selected
pending patent applications for technologies not related to Riquent or our small molecule SSAO
inhibitors that are no longer being pursued and an increase in consulting expenses for market
research. The decrease for the nine months ended September 30, 2007 was primarily due to a
decrease in termination benefits, mainly severance of approximately $0.9 million and additional
expense of approximately $0.8 million for accelerated stock option vesting related to the former
Chairman and Chief Executive Officers departure in the first quarter of 2006. This decrease was
partially offset by the write-off of selected pending patent applications noted above.
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.
11
Interest income, net remained consistent at $0.7 million for the three months ended September
30, 2007 and for the same period in 2006 and decreased to $2.0 million for the nine months ended
September 30, 2007 from $2.2 million for the same period in 2006. The decrease for the nine months
ended September 30, 2007 was due primarily to lower average balances of cash, cash equivalents and
short-term investments as compared to 2006.
Liquidity and Capital Resources
From inception through September 30, 2007, we have incurred a cumulative net loss of
approximately $338.4 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 September 30, 2007, we have raised approximately
$375.6 million in net proceeds from sales of equity securities.
At September 30, 2007, we had $50.1 million in cash, cash equivalents and short-term
investments, as compared to $42.9 million at December 31, 2006. Our working capital at September
30, 2007 was $42.6 million, as compared to $37.7 million at December 31, 2006. The increase in
cash, cash equivalents and short-term investments resulted from the net proceeds of $37.9 million
from the sale of 6.7 million shares of our common stock in April 2007 offset by the use of our
financial resources to fund our clinical trial and manufacturing activities, research and
development efforts and for other general corporate purposes. We invest our cash in United States
government-backed securities, debt instruments of entities with strong credit ratings and money
market funds. As of September 30, 2007, we classified all of our investments as available-for-sale
securities because we expect to sell them in order to support our current operations regardless of
their maturity dates. As of September 30, 2007, available-for-sale securities and cash equivalents
of $9.8 million have stated maturity dates of one year or less and $38.0 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, 2007, approximately $0.7 million of equipment ($0.3 million net of
depreciation) is financed under notes payable obligations. In December 2006, we entered into a
credit facility to fund equipment purchases of up to $1.8 million until the end of the second
quarter of 2008. In addition, 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 $1.2 million of which is included in the consolidated balance sheet as of
September 30, 2007. 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, 2007 (in
thousands). Long-term debt obligations include interest.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Payment due by period |
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
More than |
|
|
Total |
|
1 Year |
|
1-3 Years |
|
3-5 Years |
|
5 Years |
Long-Term Debt Obligations |
|
$ |
323 |
|
|
$ |
118 |
|
|
$ |
205 |
|
|
$ |
|
|
|
$ |
|
|
Operating Lease Obligations |
|
|
1,645 |
|
|
|
822 |
|
|
|
823 |
|
|
|
|
|
|
|
|
|
Purchase Obligations |
|
|
1,303 |
|
|
|
1,303 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
3,271 |
|
|
$ |
2,243 |
|
|
$ |
1,028 |
|
|
$ |
|
|
|
$ |
|
|
|
|
|
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 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.
12
We anticipate
that our existing cash, cash investments, including the net proceeds of
approximately $37.9 million that we received from the sale of common stock in April 2007, and the
interest earned thereon, will be sufficient to fund our operations as
currently planned into the third 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 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 will 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 establishing one or
more collaborative arrangements and by issuing our securities. 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.
|
|
|
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 officer and principal
financial officer, evaluated the effectiveness of our disclosure controls and procedures as of
September 30, 2007. 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
13
September 30, 2007, 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 September 30, 2007 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
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) |
|
|
|
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. |
14
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 8, 2007 |
/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) |
|
|
15
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 |