Form 10-Q
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, 2011
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
(State or other jurisdiction of
incorporation or organization)
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33-0361285
(I.R.S. Employer
Identification No.) |
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4370 La Jolla Village Drive, Suite 400
San Diego, CA
(Address of principal executive offices)
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92122
(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 has submitted electronically and posted on its
corporate Web site, if any, every Interactive Data File required to be submitted and posted
pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period
that the registrant was required to submit and post such files).
Yes 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 definition of large accelerated filer,
accelerated filer and smaller reporting company in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o
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Smaller reporting company þ |
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, $0.0001 par value per share, outstanding at
November 9, 2011 was 79,141,309.
LA JOLLA PHARMACEUTICAL COMPANY
FORM 10-Q
QUARTERLY REPORT
INDEX
PART I. FINANCIAL INFORMATION
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ITEM 1. |
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CONDENSED FINANCIAL STATEMENTS UNAUDITED |
LA JOLLA PHARMACEUTICAL COMPANY
Condensed Consolidated Balance Sheets
(in thousands, except share and par value amounts)
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September 30, |
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December 31, |
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2011 |
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2010 |
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(Unaudited) |
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(See Note) |
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ASSETS |
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Current assets: |
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Cash and cash equivalents |
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$ |
5,502 |
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$ |
6,866 |
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Prepaids and other current assets |
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9 |
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67 |
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Total current assets |
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5,511 |
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6,933 |
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Total assets |
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$ |
5,511 |
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$ |
6,933 |
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LIABILITIES, REDEEMABLE CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS (DEFICIT) EQUITY |
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Current liabilities: |
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Accounts payable |
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$ |
23 |
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$ |
39 |
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Accrued expenses |
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151 |
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178 |
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Accrued payroll and related expenses |
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83 |
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85 |
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Derivative liabilities |
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2,372 |
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6,102 |
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Total current liabilities |
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2,629 |
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6,404 |
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Series C-11 redeemable convertible preferred stock, $0.0001 par value; 11,000
shares authorized, 5,140 and 5,573 shares issued and outstanding at September 30, 2011 and
December 31, 2010, respectively (redemption value and liquidation preference in the aggregate
of $5,140 at September 30, 2011 and $5,652 at December 31, 2010) (see Notes 1 and 5) |
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5,140 |
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47 |
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Commitments and contingencies |
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Stockholders (deficit) equity: |
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Common stock |
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6 |
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Additional paid-in capital |
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424,042 |
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428,563 |
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Accumulated deficit |
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(426,306 |
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(428,081 |
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Total stockholders (deficit) equity |
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(2,258 |
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482 |
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Total liabilities, redeemable convertible preferred stock and stockholders (deficit) equity |
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$ |
5,511 |
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$ |
6,933 |
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Note: The condensed consolidated balance sheet at December 31, 2010 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 Note 1).
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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2011 |
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2010 |
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2011 |
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2010 |
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Expenses: |
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Research and development |
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$ |
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$ |
4 |
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$ |
177 |
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$ |
13 |
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General and administrative |
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423 |
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698 |
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1,628 |
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3,366 |
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Total expenses |
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423 |
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702 |
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1,805 |
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3,379 |
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Loss from operations |
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(423 |
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(702 |
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(1,805 |
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(3,379 |
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Other income (expense): |
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Fair value of derivative liabilities upon issuance |
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(5,015 |
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Adjustments to fair value of derivative liabilities |
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3,993 |
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480 |
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3,346 |
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3,465 |
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Financing transaction costs |
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(163 |
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Other income (expense), net |
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234 |
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(1 |
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Net income (loss) |
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3,570 |
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(222 |
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1,775 |
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(5,093 |
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Preferred stock dividends forfeited (earned) |
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(3 |
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(247 |
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75 |
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(334 |
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Net income (loss) and comprehensive income (loss)
attributable to common stockholders |
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$ |
3,567 |
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$ |
(469 |
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$ |
1,850 |
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$ |
(5,427 |
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Net income (loss) per basic share (Note 2 and Note 9) |
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$ |
0.07 |
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$ |
(0.49 |
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$ |
0.08 |
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$ |
(6.84 |
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Net income (loss) per diluted share (Note 2 and Note 9) |
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$ |
0.00 |
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$ |
(0.49 |
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$ |
0.00 |
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$ |
(6.84 |
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Shares used in computing basic net income (loss) per
share (Note 2 and Note 9) |
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53,341 |
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947 |
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22,418 |
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793 |
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Shares used in computing diluted net income (loss) per
share (Note 2 and Note 9) |
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1,288,000 |
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947 |
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4,869,581 |
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793 |
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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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2011 |
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2010 |
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Operating activities: |
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Net income (loss) |
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$ |
1,775 |
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$ |
(5,093 |
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Adjustments to reconcile net income (loss) to net cash used for
operating activities: |
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Share-based compensation expense |
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194 |
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402 |
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Issuance of Series C-11 Preferred Stock for services |
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12 |
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Fair value of derivative liabilities upon issuance |
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5,015 |
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Gain on adjustments to fair value of derivative liabilities |
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(3,346 |
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(3,465 |
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Change in operating assets and liabilities: |
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Prepaids and other current assets |
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58 |
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423 |
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Accounts payable and accrued expenses |
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(43 |
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(202 |
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Accrued payroll and related expenses |
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(2 |
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(77 |
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Net cash used for operating activities |
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(1,364 |
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(2,985 |
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Financing activities: |
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Proceeds from issuance of derivative obligations |
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6,003 |
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Net cash provided by financing activities |
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6,003 |
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Net (decrease) increase in cash and cash equivalents |
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(1,364 |
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3,018 |
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Cash and cash equivalents at beginning of period |
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6,866 |
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4,254 |
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Cash and cash equivalents at end of period |
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$ |
5,502 |
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$ |
7,272 |
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Supplemental schedule of noncash investing and financing activities: |
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Decrease in par value of capital stock from change in par value |
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$ |
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$ |
651 |
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Issuance of common stock at par value, offset by paid-in capital
reduction |
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$ |
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$ |
3 |
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Conversion of preferred stock into common stock |
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$ |
748 |
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$ |
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Reclassification of preferred stock currently redeemable |
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$ |
5,532 |
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$ |
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Preferred stock dividends forfeited (earned) |
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$ |
75 |
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$ |
(334 |
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See accompanying notes.
3
LA JOLLA PHARMACEUTICAL COMPANY
Notes to Condensed Consolidated Financial Statements
(Unaudited)
September 30, 2011
1. Basis of Presentation
The accompanying unaudited condensed consolidated financial statements of La Jolla Pharmaceutical
Company and its formerly wholly-owned subsidiary Jewel Merger Sub, Inc. (which was sold in June
2011, as described below in Note 4) (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 8 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 valuation adjustments)
considered necessary for a fair presentation have been included. Operating results for the three
and nine months ended September 30, 2011 are not necessarily indicative of the results that may be
expected for other quarters or the year ending December 31, 2011. 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, 2010 included in the Companys Form 10-K filed with the Securities and Exchange
Commission on April 14, 2011.
The Company has a history of recurring losses from operations and, as of September 30, 2011, the
Company had no revenue sources, an accumulated deficit of $426,306,000 and available cash and cash
equivalents of $5,502,000 of which up to $5,140,000 could be required to be paid upon the exercise
of redemption rights under the Companys outstanding preferred securities. Such redemption was not
considered probable as of September 30, 2011. These factors raise substantial doubt about the
Companys ability to continue as a going concern. 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
its liabilities in the normal course of business and this does not include any adjustments to
reflect the possible future effects on the recoverability and classification of assets or the
amounts and classification of liabilities that might be necessary should the Company be unable to
continue as a going concern.
In March 2011, the Company and its formerly wholly-owned subsidiary, Jewel Merger Sub, Inc.
acquired the rights to compounds known as Regenerative Immunophilin Ligands (RILs or Compounds)
from privately held GliaMed, Inc. (GliaMed). The Compounds were acquired pursuant to an Asset
Purchase Agreement (the Asset Agreement) for a nominal amount, and if certain development and
regulatory milestones were met, the Company would have paid GliaMed additional consideration
consisting of up to 8,205 shares of newly designated Series E Convertible Preferred Stock (Series
E Preferred), which would have been convertible into approximately 20% of the Companys fully
diluted outstanding common stock on an as-converted basis. GliaMed would have also been eligible
for a potential cash payment from the Company if a Compound was approved by the Food and Drug
Administration, or FDA, or European Medicines Agency, or EMA, in two or more clinical indications
(see Note 4).
4
Also in March 2011, the Company entered into a Consent and Amendment Agreement (the Consent
Agreement), dated as of March 29, 2011, with certain holders of convertible redeemable Series C-1
preferred stock (Series C-1 Preferred), in order to amend certain terms of the Companys
Securities Purchase Agreement, dated as of May 24, 2010 (Securities Purchase Agreement) (see Note
5). The purpose of the Consent Agreement was to revise certain terms of the Companys outstanding
preferred securities in connection with the Companys acquisition of the Compounds. Additionally,
as part of the Consent Agreement, the Company designated five new series of preferred stock: its
Series C-11 Convertible Preferred Stock (Series C-11 Preferred), Series
C-21 Convertible Preferred Stock (Series C-21 Preferred), Series
D-11 Convertible Preferred Stock (Series D-11 Preferred), Series
D-21 Convertible Preferred Stock (Series D-21 Preferred and collectively
with the Series C-11 Preferred, the Series C-21 Preferred and the Series
D-11 Preferred, the New Preferred Stock) and Series E Preferred. The Company
exchanged on a one-for-one basis each share of its existing Series C-1 Preferred that was
outstanding for a new share of Series C-11 Preferred (see Note 5). Unless otherwise
indicated, references herein to Series C-11 Preferred reflect the one-for-one exchange.
Following the acquisition of the Compounds, the Company initiated a confirmatory preclinical animal
study in April 2011 studying the lead RIL compound, LJP1485. This study was completed in May 2011,
after which the Company received final data from Charles River Laboratories, the Companys clinical
research organization (the CRO), which showed that the predetermined study endpoints, as set
forth in the Asset Agreement, were not met and that the LJP1485 compound did not show statistically
significant improvement in the study endpoints as compared to vehicle (placebo).
Pursuant to the Consent Agreement, the Companys existing holders of Series C-11
Preferred (the Preferred Stockholders) were not required to exercise their cash warrants (the
Cash Warrants) due to the failure of the LJP1485 study. The Preferred Stockholders elected to
not exercise the Cash Warrants, which then provided GliaMed with the right to reacquire the
Compounds through the purchase of the outstanding capital stock of Jewel Merger Sub, Inc. (which
held title to the Compounds) for the same nominal consideration that GliaMed received at the
closing of the Companys acquisition of the Compounds.
The cost for this preclinical study, including the Companys operating costs, of approximately
$712,000 was funded through cash on hand, which was made available for this expense due to the
forfeiture of dividends on the Companys outstanding Series C-11 Preferred and Series
C-21 Preferred (together the Series C1 Preferred) for the period from
November 26, 2010 to May 31, 2011 (the Forfeited Dividend), the receipt of cash from certain
current investors pursuant to the Consent Agreement, and a temporary reduction in the salaries of
the Companys current officers. The stockholders no longer have any rights to receive stock for
their Forfeited Dividend or any consideration for the cash payment made pursuant to the Consent
Agreement.
On June 30, 2011, the Company entered into an Amendment Agreement with certain holders of Series
C-11 Preferred (the Holders) in order to provide the Company with additional working
capital to allow the Company to more fully evaluate additional product acquisition or in-licensing
opportunities. The Holders agreed to waive the dividends on their shares of Series C-11
Preferred for the period from June 1, 2011 to August 31, 2011 and agreed to provide the Company
with additional working capital by July 29, 2011, in an amount to be determined. In addition, the
Companys two executive officers agreed to a temporary reduction in their salaries and work hours
from July 1, 2011 to August 31, 2011. As of August 24, 2011, no additional working capital had been
contributed to the Company.
On August 24, 2011, the Company entered into a Second Amendment Agreement with the Holders in order
to provide the Company with additional working capital to allow the Company to continue to evaluate
additional product acquisition or in-licensing opportunities that are currently being investigated.
The Holders agreed to extend the waived dividends and the two executive officers agreed to extend
the temporary reduction in their salaries and work hours through October 31, 2011. The Holders
also agreed to provide the Company with additional working
capital, in an amount to be determined, by September 2, 2011 and then again by September 26, 2011,
if as of such dates, the Company was continuing to pursue a Strategic Transaction. In September
2011, in accordance with the Consent Agreement, certain of the Holders agreed to waive the
preferred stock conversion limits and converted 25 shares of Series C1 Preferred into
common stock. The conversion reduced the redemption value of the Series C-11 Preferred
by $25,000 and therefore increased working capital by the same amount. The dividends waived from
June 1, 2011 through October 31, 2011 are referred to as the Waived Dividend. As of September
30, 2011, the Preferred Stockholders have the right to require the Company to redeem all
outstanding shares of Series C-11 Preferred for an aggregate sum of approximately
$5,140,000. If the Preferred Stockholders exercise this redemption right, the Company would have
insufficient cash to sustain its operations and the Company would likely need to wind down all
activities.
5
2. Accounting Policies
Principles of Consolidation
The accompanying unaudited condensed consolidated financial statements include the accounts of La
Jolla Pharmaceutical Company and its formerly wholly-owned subsidiary, Jewel Merger Sub, Inc.
(Jewel Merger Sub), which was incorporated in Delaware in December 2009. In March 2011, the
Company and Jewel Merger Sub acquired assets related to certain Compounds from GliaMed. In June
2011, GliaMed repurchased the Compounds by acquiring all of the outstanding capital stock of Jewel
Merger Sub for the same nominal amount that it received from the Company for the Compounds.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with GAAP requires
management to make estimates and assumptions that affect the amounts reported in the unaudited
condensed consolidated financial statements and disclosures made in the accompanying notes to the
unaudited condensed consolidated financial statements. These include the assumptions discussed
below relating to the calculation of our derivative liabilities. Actual results could differ
materially from those estimates.
Recent Accounting Pronouncements
In May 2011, the FASB issued authoritative guidance regarding common fair value measurements and
disclosure requirements in U.S. GAAP and IFRS. This newly issued accounting standard clarifies the
application of certain existing fair value measurement guidance and expands the disclosures for
fair value measurements that are estimated using significant unobservable inputs. This guidance is
effective on a prospective basis for annual and interim reporting periods beginning after December
15, 2011. The Company does not expect that adoption of this standard will have a material impact
on its financial position or results of operations.
In June 2011, the FASB issued authoritative guidance regarding comprehensive income. This newly
issued accounting standard (1) eliminates the option to present the components of other
comprehensive income as part of the statement of changes in stockholders equity; (2) requires the
consecutive presentation of the statement of net income and other comprehensive income; and (3)
requires an entity to present reclassification adjustments on the face of the financial statements
from other comprehensive income to net income. The amendments do not change the items that must be
reported in other comprehensive income or when an item of other comprehensive income must be
reclassified to net income nor do the amendments affect how earnings per share is calculated or
presented. This guidance is required to be applied retrospectively and is effective for fiscal
years and interim periods beginning after December 15, 2011. As this accounting standard only
requires enhanced disclosure, the adoption of this standard will not impact the Companys financial
position or results of operations.
6
Impairment of Long-Lived Assets
If indicators of impairment exist, the Company assesses the recoverability of the affected
long-lived assets by determining whether the carrying value of such assets can be recovered through
the undiscounted future operating cash flows.
As a result of the negative results in the confirmatory preclinical study of LJP1485 in May 2011,
the Company discontinued the development of LJP1485 in May 2011 and in June 2011 the Company sold
the Compounds back to GliaMed for the same nominal amount that it had paid for them. Based on these
events, the future cash flows from the patents related to the Compounds were no longer expected to
exceed their carrying values and the assets became impaired as of May 31, 2011. Accordingly, during
the quarter ended June 30, 2011, the Company recorded a non-cash charge of $243,000 to general and
administrative expense for the impairment of long-lived assets to write down the value of the
Companys patents to their estimated fair values.
Reverse Stock Split
The Board of Directors approved the reverse stock split (the Reverse Stock Split) of the
Companys common stock, which became effective on April 14, 2011, with an exchange ratio of
1-for-100. As a result of the Reverse Stock Split, each 100 shares of the Companys issued and
outstanding common stock were automatically reclassified as and changed into one share of the
Companys common stock. No fractional shares were issued in connection with the Reverse Stock
Split. Stockholders who were entitled to fractional shares instead became entitled to receive a
cash payment in lieu of receiving fractional shares (after taking into account and aggregating all
shares of the Companys common stock then held by such stockholder) equal to the fractional share
interest. The Reverse Stock Split affected all of the holders of the Companys common stock
uniformly. Shares of the Companys common stock underlying outstanding options and warrants were
proportionately reduced and the exercise prices of outstanding options and warrants were
proportionately increased in accordance with the terms of the agreements governing such securities.
Shares of the Companys common stock underlying outstanding convertible preferred stock and
warrants were proportionately reduced and the conversion rates were proportionately decreased in
accordance with the terms of the agreements governing such securities. All common stock share and
per share information in the unaudited condensed consolidated financial statements and notes
thereto included in this report have been restated to reflect retrospective application of the
Reverse Stock Split for all periods presented, except for par value per share and the number of
authorized shares, which were not affected by the Reverse Stock Split. The Board of Directors
continues to have the authority from the Companys stockholders to implement an additional reverse
stock split at a ratio of up to 1-for-100.
Net Income (Loss) Per Share
Basic and diluted net income (loss) per share is computed using the weighted-average number of
common shares outstanding during the periods. 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 stock equivalents. Diluted EPS is computed by dividing
the net income or loss by the weighted-average number of common shares and common stock equivalents
outstanding for the period issuable upon the conversion of preferred stock and exercise of stock
options and warrants. These common stock equivalents are included in the calculation of diluted
EPS only if their effect is dilutive (see Note 9). There is no difference between basic and diluted
net loss per share for the three and nine months ended September 30, 2010 as potentially dilutive
securities have been excluded from the calculation of diluted net loss per common share because the
inclusion of such securities would be antidilutive.
7
Derivative Liabilities
In May 2010, the Company entered into definitive agreements with institutional investors and
affiliates for a private placement of common stock, redeemable convertible preferred stock and
warrants to purchase convertible preferred stock for initial proceeds of $6,003,000 (the May 2010
Financing). In conjunction with the May 2010 Financing, the Company issued redeemable convertible
preferred stock that contained certain embedded derivative features, as well as warrants that are
accounted for as derivative liabilities (see Notes 3 and 5). These derivative liabilities were
determined to be ineligible for equity classification due to certain provisions of the underlying
preferred stock, which is also ineligible for equity classification, whereby redemption is outside
the sole control of the Company and due to provisions that may result in an adjustment to their
exercise or conversion price.
The Companys derivative liabilities were initially recorded at their estimated fair value on the
date of issuance and are subsequently adjusted to reflect the estimated fair value at each period
end, with any decrease or increase in the estimated fair value being recorded as other income or
expense, accordingly. The fair value of these liabilities is estimated using option pricing models
that are based on the individual characteristics of the common stock and preferred stock, the
derivative liability on the valuation date, probabilities related to the Companys operations and
clinical development (based on industry data), as well as assumptions for volatility, remaining
expected life, risk-free interest rate and, in some cases, credit spread. The option pricing
models are particularly sensitive to changes in the aforementioned probabilities and the closing
price per share of the Companys common stock.
3. Fair Value of Financial Instruments
Financial assets and liabilities are measured at fair value, which is defined 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 must
maximize the use of observable inputs and minimize the use of unobservable inputs. The following is
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:
|
|
|
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. |
As of September 30, 2011 and 2010, cash and cash equivalents were comprised of cash in checking
accounts.
In conjunction with the May 2010 Financing, the Company issued redeemable convertible preferred
stock with certain embedded derivative features, as well as warrants to purchase various types of
convertible preferred stock and units. These instruments are accounted for as derivative
liabilities (see Note 5).
The Company used Level 3 inputs for its valuation methodology for the embedded derivative
liabilities and warrant derivative liabilities. The estimated fair values were determined using a
binomial option pricing model based on various assumptions (see Note 5). The Companys derivative
liabilities are adjusted to reflect their estimated fair value at each period end, with any
decrease or increase in the estimated fair value being recorded in other income or expense
accordingly, as adjustments to fair value of derivative liabilities.
8
At September 30, 2011, the estimated fair values of the liabilities measured on a recurring basis
are as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at September 30, 2011 |
|
|
|
Balance at |
|
|
Quoted Prices in |
|
|
Significant Other |
|
|
Significant |
|
|
|
September 30, |
|
|
Active Markets |
|
|
Observable Inputs |
|
|
Unobservable Inputs |
|
|
|
2011 |
|
|
(Level 1) |
|
|
(Level 2) |
|
|
(Level 3) |
|
Embedded derivative
liabilities |
|
$ |
3,166 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
3,166 |
|
Warrant derivative liabilities |
|
|
(794 |
) |
|
|
|
|
|
|
|
|
|
|
(794 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
2,372 |
|
|
$ |
|
|
|
$ |
|
|
|
$ |
2,372 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The following table presents the activity for liabilities measured at estimated fair value
using unobservable inputs for the nine months ended September 30, 2011 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements Using Significant |
|
|
|
Unobservable Inputs (Level 3) |
|
|
|
Embedded Derivative |
|
|
Warrant Derivative |
|
|
|
|
|
|
Liabilities |
|
|
Liabilities |
|
|
Total |
|
Beginning balance at December 31, 2010 |
|
$ |
5,170 |
|
|
$ |
932 |
|
|
$ |
6,102 |
|
Adjustments to estimated fair value |
|
|
(1,620 |
) |
|
|
(1,726 |
) |
|
|
(3,346 |
) |
Decrease of the embedded derivative
liabilities for preferred shares
converted into common stock |
|
|
(315 |
) |
|
|
|
|
|
|
(315 |
) |
Forfeited accrued dividends payable
in Series C-11 Preferred |
|
|
(72 |
) |
|
|
|
|
|
|
(72 |
) |
Accrued dividends payable in Series
C-11 Preferred |
|
|
3 |
|
|
|
|
|
|
|
3 |
|
|
|
|
|
|
|
|
|
|
|
Ending balance at September 30, 2011 |
|
$ |
3,166 |
|
|
$ |
(794 |
) |
|
$ |
2,372 |
|
|
|
|
|
|
|
|
|
|
|
During the three and nine months ended September 30, 2011, the net decrease in the estimated fair value of derivative
liabilities of $3,993,000 and $3,346,000, respectively, was recorded as non-cash other income in the
Statement of Operations.
4. GliaMed Asset Purchase
In March 2011, the Company and Jewel Merger Sub acquired assets related to certain RIL compounds
from GliaMed. The Compounds were acquired pursuant to the Asset Agreement for a nominal amount,
and if certain milestones noted below were met, the Company would have paid GliaMed additional
consideration of up to 8,205 shares of newly designated convertible Series E Preferred, which would
have been convertible into approximately 20% of the Companys fully diluted outstanding common
stock on an as-converted basis. The issuance of the shares was tied to the achievement of certain
development and regulatory milestones. GliaMed was also eligible to receive a cash payment from the
Company of $5,000,000 if a Compound was approved by the FDA or EMA in two or more clinical
indications.
In late May, 2011, the Company received final data from the Companys CRO, which showed that the
predetermined study endpoints, as set forth in the Asset Agreement, were not met and that the
LJP1485 compound did not show statistically significant improvement in the study endpoints as
compared to vehicle (placebo).
9
The purchase was originally recorded as a long-term other asset for the intangible rights received
related to the Compounds equal to the nominal amount paid to GliaMed plus the asset acquisition
costs incurred for legal services and due diligence related to the investigation of the underlying
technology. As a result of the negative results in the confirmatory preclinical study in May 2011,
the Company discontinued the development of LJP1485 in May 2011 and in June 2011 the Company sold
the Compounds back to GliaMed by selling all of the outstanding capital stock of Jewel Merger Sub
to GliaMed for the same nominal amount that it had paid for the Compounds.
Jewel Merger Sub had no other assets or liabilities other than those relating to the Compounds and
related assets and contract rights.
5. Securities Purchase Agreement
On May 24, 2010, the Company entered into a Securities Purchase Agreement by and among the Company
and the purchasers named therein (the Purchasers). The Purchasers included institutional
investors as well as the Companys Chief Executive Officer, Chief Financial Officer and an
additional Company employee. The total investment by these Company employees represented less than
3% of the proceeds received by the Company in the May 2010 Financing. Pursuant to the Securities
Purchase Agreement, on May 26, 2010 (the Closing Date or Closing), for total consideration of
$6,003,000, the Purchasers purchased (i) an aggregate of 289,704 shares of the Companys Common
Stock, par value $0.0001 per share, at a contractually stated price of $3.00 per share, and (ii)
5,134 shares of the Companys Series C-11 Preferred, par value $0.0001 per share, at a
contractually stated price of $1,000 per share. The Purchasers also received (i) Series
D-11 Warrants to purchase 5,134 shares of the Companys Series D-11
Preferred, par value $0.0001 per share, at an exercise price of $1,000 per share, which warrants
may be exercised on a cashless basis, and (ii) Series C-21 Warrants to purchase 10,268
units, at an exercise price of $1,000 per unit, which warrants are exercisable only in cash, with
each unit consisting of one share of the Companys Series C-21 Preferred, par value
$0.0001 per share, and an additional Series D-21 Warrant to purchase one share of the
Companys Series D-21 Preferred, par value $0.0001 per share, at an exercise price of
$1,000 per share.
In March 2011, the Company entered into the Consent Agreement which amended the terms of the
Securities Purchase Agreement. Under the Consent Agreement, the holders agreed to the following,
among other changes: (i) a temporary suspension of dividends on Series C-11 Preferred
and Series C-21 Preferred (ii) to provide an additional cash payment of approximately
$236,000 in exchange for the right to receive Series C-21 Preferred upon the achievement
of certain pre-specified results in the preclinical study of one of the Compounds (the Preclinical
Milestone), (iii) to increase the warrants that must be exercised for cash from 10,268 to 10,646
units, (iv) the mandatory exercise of $7,452,000 of such warrants upon the achievement of the
Preclinical Milestone, (v) the mandatory exercise of the remaining $3,194,000 of warrants upon the
achievement of a future clinical milestone and (vi) an automatic one time downward conversion price
adjustment following the Reverse Stock Split.
In June 2011, the Company entered into the Amendment Agreement which amended the terms of the
Securities Purchase Agreement and the Consent Agreement. Under the Amendment Agreement, the Holders
agreed to the following, among other changes: (i) a temporary waiver of dividends on Series
C1 Preferred (ii) to provide additional working capital by July 29, 2011, in an amount
to be determined, if the Requisite Holders (as defined in the Amendment Agreement) determined by
July 22, 2011 that, as of such date, the Company was continuing to pursue a Strategic Transaction
(as defined in the Amendment Agreement) (iii) to purchase up to all of the outstanding Series
C1 Preferred and certain warrants held by current and former Company employees,
including the executive officers, who will have the right to require the Holder to purchase these
securities for a limited period of time following the employees termination of service with the
Company.
10
In August 2011, the Company entered into a Second Amendment Agreement which extended the terms
of the Amendment Agreement through October 31, 2011. Under the Second Amendment Agreement, the
Holders agreed to the following, among other changes: (i) to continue a temporary waiver of
dividends on Series C1 Preferred (ii) to provide additional working capital, in an
amount to be determined, if the Requisite Holders (as defined in the Second Amendment Agreement)
determine by September 2, 2011, and then again by September 26, 2011, that, as of such date, the
Company was continuing to pursue a Strategic Transaction (as defined in the Second Amendment
Agreement) (iii) to purchase up to all of the outstanding Series C1 Preferred and
certain warrants held by current and former Company employees, including the executive officers,
who will have the right to require the Holder to purchase these securities for a limited period of
time following the employees termination of service with the Company. As of
November 9, 2011, the Company is continuing its efforts to pursue a Strategic
Transaction and is in the process of negotiating a third amendment to extend the terms of the Amendment Agreement.
Allocation of Proceeds
At the Closing Date, the estimated fair value of the Series C-21 Warrants for units,
Series D-11 Warrants, and the embedded derivatives included within the Series
C-11 Preferred exceeded the proceeds from the May 2010 Financing of $6,003,000 (see the
valuations of these derivative liabilities under the heading, Derivative Liabilities below). As a
result, all of the proceeds were allocated to these derivative liabilities and no proceeds remained
for allocation to the Common Stock and Series C-11 Preferred issued in the financing.
Common Stock
Pursuant to Rule 144 under the Securities Act of 1933 the Purchasers were restricted from selling
the Common Stock until November 2010, which was six months after the Closing Date.
Redeemable Preferred Stock
As of September 30, 2011, the Companys Board of Directors is authorized to issue 8,000,000 shares
of preferred stock, with a par value of $0.0001 per share, in one or more series, of which 11,000
are designated for Series C-11 Preferred, 22,000 are designated Series C-21
Preferred, 5,134 are designated Series D-11 Preferred, 10,868 are designated Series
D-21 Preferred, and 12,000 are designated Series E Preferred. As of September 30, 2011,
5,140 shares of Series C-11 Preferred Stock are issued and outstanding. There were no
shares of any other series of preferred stock issued and outstanding as of September 30, 2011.
Voting Rights
The holders of New Preferred Stock do not have voting rights other than for general protective
rights required by the Delaware General Corporation Law or as set forth below.
Dividends
Cumulative dividends are payable on the Series C1 Preferred at an annual rate of 15%
from the date of issuance through the date of conversion or redemption, payable semi-annually each
November 25th and May 25th in shares of Series C1 Preferred. There
is no limit to the number of shares of Series C1 Preferred that may be issued as
dividends. Neither the Series D-11 Preferred nor the Series D-21 Preferred
(if and when issued) is entitled to dividends.
As discussed in Note 1, the Company funded its confirmatory preclinical study of the RIL compounds
in part through the Forfeited Dividend and is funding its current operations in part through the
Waived Dividend. From June 1 through August 31, 2011, there was an accrual of five shares Series
C1 Preferred payable to current and former Company employees who are holders of Series
C1 Preferred. These holders waived their dividends as part of the Second Amendment
Agreement effective after August 31, 2011.
11
Conversion Rights
The New Preferred Stock was convertible into common stock, initially at a rate of 667 shares of
common stock for each share of New Preferred Stock, subject to certain limitations discussed below,
at the election of the holders of New Preferred Stock. The conversion rate will be adjusted for
certain events, such as stock splits, stock dividends, reclassifications and recapitalizations, and
the New Preferred Stock is subject to full-ratchet anti-dilution protection such that if the
Company issues or grants any warrants, rights, options to subscribe or purchase common stock or
common stock equivalents (the Options) and the price per share for which the common stock
issuable upon the exercise of such Options is below the effective conversion price of the New
Preferred Stock at the time of such issuance, then the conversion rate of the New Preferred
Stock automatically adjusts to increase the number of common shares into which it can
convert. There are also limits on the amount of New Preferred Stock that can be converted and the
timing of such conversions. In accordance with the Consent Agreement, after the Reverse Stock
Split, the conversion ratio for the New Preferred Stock was adjusted based on the trading price of
the Companys common stock over a period of time after the Reverse Stock Split was implemented.
Accordingly, effective May 7, 2011, each share of New Preferred Stock is now convertible into
approximately 166,667 shares of common stock.
Effective with the Consent Agreement, in any week, each holder of New Preferred Stock may convert its amount of
the outstanding New Preferred Stock held by the stockholder multiplied by the Conversion Cap (as
defined in the Certificate of Designations for the Series C-11, C-21,
D-11 and D-21 Preferred (the Series C1/D1
Certificate) for such week. Depending on the Closing Sales Prices (as defined in the Series
C1/D1 Certificate), the Conversion Cap can range from 0% to 7.2%. Moreover,
holders of New Preferred Stock may not convert if such conversion would result in the holder or any
of its affiliates beneficially owning more than 9.999% of the Companys then issued and outstanding
shares of common stock. As of September 30, 2011, 433 shares of Series C-11 Preferred
had been converted into common stock.
Upon certain redemption events, as set forth in the Securities Purchase Agreement, and as
subsequently amended in the Consent Agreement, the conversion price of the New Preferred Stock
decreases to 10% of the conversion price in effect immediately before such redemption event thereby
increasing the number of common shares that would be issued for each share of New Preferred Stock
by a factor of ten times.
Liquidation Preference
Upon a Liquidation Event (as defined in the Series C1/D1 Certificate), no
other class or series of capital stock can receive any payment unless the Preferred Stock has first
received a payment in an amount equal to $1,000 per share, plus all accrued and unpaid dividends,
if applicable.
Redemption Rights
In the event that certain actions occur without the waiver or prior written consent of the holders
of two-thirds of the then outstanding shares of New Preferred Stock (the Requisite Holders), such
as the Companys material breach of any material representation or warranty under the Securities
Purchase Agreement, a suspension of the trading of the Companys common stock, the failure to
timely deliver shares on conversion of the New Preferred Stock, bankruptcy reorganization or the
consummation of a Change of Control (as defined in the Series C1/D1
Certificate) among others, then the holders of the Series C1 Preferred shall have the
right, upon the delivery of a notice to the Company by the Requisite Holders, to have such shares
redeemed by the Company for an amount equal to the greater of $1,000 per share, plus accrued and
unpaid dividends, or the fair market value of the underlying common stock issuable upon conversion
of the Series C1 Preferred, which could include a greater number of shares pursuant to
the conversion reset described above under the caption Conversion Rights. As of September 30,
2011 and through the date of this filing, none of these redemption actions have occurred to the
Companys knowledge.
12
Since the Company failed to consummate a Strategic Transaction (as defined in the Series
C1/D1 Certificate) by February 26, 2011 (nine months from the May 26, 2010
Closing), the Series C1 Preferred may be redeemed upon the demand of the Requisite
Holders. The redemption price
would be equal to $1,000 per share, plus accrued and unpaid dividends. As of September 30, 2011,
the redemption value was $5,140,000. This redemption feature terminates upon the consummation of a
Strategic Transaction, which must be first approved by the Requisite Holders. The Requisite Holders
may also waive this redemption feature. If the Requisite Holders fail to demand redemption of the
Series C1 Preferred within two years from the date of a Redemption Event (as defined in
the Series C1/D1 Certificate), then the redemption rights with respect to
such Redemption Event shall be irrevocably waived by the preferred stockholders. The Requisite
Holders have not elected to redeem through the date of the filing of this Report, nor have they
waived this right.
Restrictions
So long as at least 1,000 shares of New Preferred Stock remain outstanding (or at least 3,000
shares of New Preferred Stock remain outstanding if the Series C-21 Warrants have been
exercised), the Company may not take a variety of actions (such as altering the rights, powers,
preferences or privileges of the New Preferred Stock so as to affect the New Preferred Stock
adversely, amending any provision of the Companys certificate of incorporation, entering into an
agreement for a Strategic Transaction or Change of Control, consummating any financing or filing a
registration statement with the Securities and Exchange Commission, or SEC) without the prior
approval of the Requisite Holders. From May 2010 through April 2011, the Company had also agreed to
certain limitations on its spending per month based on predetermined budgeted amounts.
Accounting Treatment
At the Closing Date, the Company issued 5,134 shares of Series C-11 Preferred and
recorded the par value of $0.0001 per share with a corresponding reduction to paid-in capital,
given that there was no allocated value from the proceeds to the Series C-11 Preferred.
In a separate transaction, in exchange for a first right of negotiation for a product candidate,
the Company issued approximately 50 shares of Series C-11 Preferred convertible into
approximately 8,333,000 shares of the Companys common stock to a Purchaser on May 26, 2010. Using
the present value of the face amount of the Series C-11 Preferred at Closing, these
shares were valued at $12,000 and were fully charged to general and administrative expense during
the three months ended June 30, 2010.
Under accounting guidance covering accounting for redeemable equity instruments, preferred
securities that are redeemable for cash or other assets are to be classified outside of permanent
equity (within the mezzanine section between liabilities and equity on the condensed consolidated
balance sheets) if they are redeemable at the option of the holder or upon the occurrence of an
event that is not solely within the control of the issuer. As there are redemption-triggering
events related to the Series C1 Preferred that are not solely within the control of the
Company, the Series C-11 Preferred was classified outside of permanent equity.
As of September 30, 2011, the outstanding Series C-11 Preferred is convertible into
approximately 856,676,000 shares of common stock. The Company may be required to redeem the Series
C-11 Preferred if a redemption event occurs, such as the failure to consummate a
Strategic Transaction. Since the Company did not consummate a Strategic Transaction by February
26, 2011, the Series C-11 Preferred is currently redeemable and therefore the Company
has adjusted the carrying value of the Series C-11 Preferred to the redemption value of
such shares which, as of September 30, 2011, was $5,140,000.
13
As of December 31, 2010, accrued dividends on the Series C-11 Preferred were $6,000,
which consisted of 79 shares of Series C-11 Preferred, or approximately 0.014 dividend
shares per Series C-11 Preferred share outstanding, convertible into approximately
13,167,000 shares of common stock. Due to the forfeiture of dividends on the Companys outstanding
Series C1 Preferred for the period from November 26, 2010 to May 31, 2011 as discussed
in Note 1, the accrued dividends of $6,000 as of December 31, 2010 were reversed.
As of September 30, 2011 accrued dividends on the Series C-11 Preferred were $501, which
consisted of 5 shares of Series C-11 Preferred, payable to the current and former
Company employees for the period June 1, 2011 to August 31, 2011. The accrued dividends are
convertible into approximately 902,000 shares of common stock. Due to the waiver of dividends as
discussed in Note 1, the dividends for current and former Company employees were waived from August
31, 2011 to October 31, 2011 and the dividends for the key investors were waived from June 1, 2011
to October 31, 2011.
Derivative Liabilities
The Series C-11 Preferred and the underlying securities of the Series C-21
Warrants for units and Series D-11 Warrants (Series C1 Preferred and Series
D1 Preferred) contain conversion features. In addition, the Series C-11
Preferred and the underlying securities of the Series C-21 Warrants for units (Series
C1 Preferred) are subject to redemption provisions that are outside of the control of
the Company.
The Series C-21 Warrants and Series D-11 Warrants are exercisable starting on
the issuance date and expire in three years from the date of issuance. The Series C-21
Warrants must be exercised in cash and beginning in June 2011, they are no longer subject to
mandatory exercise terms. The Series D-11 Warrants may be exercised on a cashless basis
and are not subject to mandatory exercise terms.
Accounting Treatment
The Company accounted for the conversion and redemption features embedded in the Series
C-11 Preferred (the Embedded Derivatives) in accordance with accounting guidance
covering derivatives. Under this accounting guidance, companies may be required to bifurcate
conversion and redemption features embedded in redeemable convertible preferred stock from their
host instruments and account for these embedded derivatives as free standing derivative financial
instruments. If the underlying security of the embedded derivative requires net cash settlement in
the event of circumstances that are not solely within the Companys control, the embedded
derivative should be classified as a liability, measured at fair value at issuance and adjusted to
their current fair value at each period. As there are redemption triggering events for net cash
settlement for Series C1 Preferred that are not solely within the Companys control, and
the conversion feature is a derivative, the Embedded Derivatives are classified as liabilities and
are accounted for using fair value accounting at each reporting date (also see Note 3).
The Company accounted for the Series C-21 Warrants for units and Series D-11
Warrants in accordance with accounting guidance covering derivatives. If the underlying security of
the warrant, a.) requires net cash settlement in the event of circumstances that are not solely
within the Companys control or if not, if they are b.) not indexed to the Companys own stock, the
warrants should be classified as liabilities, measured at fair value at issuance and adjusted to
their current fair value at each period. As there are redemption triggering events for Series
C1 Preferred that are not solely within the Companys control, and the Series
D1 Preferred are not indexed to the Companys own stock, the Series C-21
Warrants for units and Series D-11 Warrants are classified as liabilities and are
accounted for using fair value accounting at each reporting date. The Embedded Derivatives, Series
C-21 Warrants for units and Series D-11 Warrants are collectively referred to
as the Derivative Liabilities.
14
The estimated fair values of the Derivative Liabilities as of December 31, 2010 and September 30,
2011 are summarized as follows (in thousands):
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at |
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2011 |
|
Embedded Derivatives of Series C-11 Preferred (including dividends paid
in Series C-11 Preferred in November 2010) |
|
$ |
5,098 |
|
|
$ |
3,163 |
|
Embedded Derivatives of accrued dividends payable in Series C-11 Preferred |
|
|
72 |
|
|
|
3 |
|
Series D-11 Warrants |
|
|
702 |
|
|
|
167 |
|
Series C-21 Warrants for: |
|
|
|
|
|
|
|
|
Series C-21 Preferred |
|
|
(1,175 |
) |
|
|
(1,307 |
) |
Series D-21 Warrants |
|
|
1,405 |
|
|
|
346 |
|
|
|
|
|
|
|
|
|
|
$ |
6,102 |
|
|
$ |
2,372 |
|
|
|
|
|
|
|
|
The Derivative Liabilities were valued using binomial option pricing models with various
assumptions detailed below. Due to the six month trading restriction on the unregistered shares of
common stock issued or issuable from the conversion of Preferred Stock and the weekly conversion
limitation on Preferred Stock as well as the uncertainty of the Companys ability to continue as a
going concern, the price per share of the Companys common stock used in the binomial option
pricing models for the Derivative Liabilities was discounted from the closing market prices of
$2.60 and $0.003 on December 31, 2010 and September 30, 2011, respectively. The expected lives that
were used to value each of the Derivative Liabilities were based on the individual characteristics
of the underlying Preferred Stock, which impact the expected timing of conversion into common
stock. In addition, the probabilities associated with the consummation of a Strategic Transaction
and the clinical development of a drug candidate based on industry data were used in each of the
binomial option pricing models. The models used to value the Series C-21 Warrants and
Series D-11 Warrants are particularly sensitive to such probabilities, as well as to the
closing price per share of the Companys common stock. In addition, as noted above, the model
included the effect of the automatic one-time downward conversion price adjustment following the
Reverse Stock Split. To better estimate the fair value of the Derivative Liabilities at each
reporting period, the binomial option pricing models and their inputs were refined based on
information available to the Company. Such changes did not have a significant impact on amounts
recorded in previous interim reporting periods.
At December 31, 2010, the total value of the Embedded Derivatives, including the estimated fair
value of Embedded Derivatives related to the accrued dividends payable in Series C-11
Preferred of $72,000 was $5,170,000. At September 30, 2011, the total value of the Embedded
Derivatives was $3,166,000, resulting in non-cash other income on the decrease in the estimated
fair value of the Embedded Derivatives for the nine months ended September 30, 2011 of $1,620,000
(exclusive of the decrease in the liability of $315,000 due to the conversion of 433 shares of
Series C-11 Preferred into common stock and the reversal of $72,000 for the December 31,
2010 accrued dividends that were forfeited and the accrued dividends of $3,000 as of September 30,
2011 for current and former Company employee holders of Series C-11 Preferred). Such
decrease in value was primarily due to the significant decrease in the Companys common stock
price, and the updates to the assumptions used in the option pricing models.
15
The Embedded Derivatives were valued at December 31, 2010 and at September 30, 2011 using a
binomial option pricing model, based on the value of the Series C-11 Preferred shares
with and without embedded derivative features, with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2011 |
|
Closing price per share of common stock |
|
$ |
2.60 |
|
|
$ |
0.003 |
|
Conversion price per share |
|
$ |
1.50 |
|
|
$ |
0.006 |
|
Volatility |
|
|
84.6 |
% |
|
|
80.7 |
% |
Risk-free interest rate |
|
|
2.19 |
% |
|
|
0.96 |
% |
Credit spread |
|
|
14.2 |
% |
|
|
20.1 |
% |
Remaining expected lives of underlying
securities (years) |
|
|
6.3 |
|
|
|
5.0 |
|
On December 31, 2010, the Series D-11 Warrants were recorded at estimated fair value of
$702,000. On September 30, 2011, the Series D-11 Warrants were revalued at $167,000
resulting in non-cash other income on the decrease in the estimated fair value of the Series
D-11 Warrants for the nine months ended September 30, 2011 of $535,000. Such decrease
in value was primarily due to the significant decrease in the Companys common stock price and the
updates to the assumptions used in the option pricing models.
The Series D-11 Warrants were valued at December 31, 2010 and at September 30, 2011
using a binomial option pricing model with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2011 |
|
Closing price per share of common stock |
|
$ |
2.60 |
|
|
$ |
0.003 |
|
Conversion price per share |
|
$ |
1.50 |
|
|
$ |
0.006 |
|
Volatility |
|
|
98.9 |
% |
|
|
83.6 |
% |
Risk-free interest rate |
|
|
1.02 |
% |
|
|
0.38 |
% |
Remaining expected lives of underlying securities (years) |
|
|
2.8 |
|
|
|
2.8 |
|
On December 31, 2010, the Series C-21 Warrants (which consist of rights to purchase
Series C-21 Preferred and Series D-21 Warrants) were recorded at an estimated
fair value of $230,000. On September 30, 2011, the Series C-21 Warrants were revalued at
a negative $961,000, resulting in non-cash other income on the decrease in the estimated fair value
of the Series C-21 Warrants for the nine months ended September 30, 2011 of $1,191,000.
Such decrease in value was primarily due to the significant decrease in the Companys common stock
price and the updates to the assumptions used in the option pricing models, offset by the increase
in the Series C-21 Warrants by 378 units. The fair value of the rights to purchase
Series C-21 Preferred was negative as of December 31, 2010 as the Series C-21
Warrants were mandatorily exercisable at a price that was greater than the fair value of the
underlying instruments. The fair value of the rights to purchase Series C-21 Preferred
was negative as of September 30, 2011 as it is assumed that upon a Strategic Transaction, Series
C-21 Warrants will be exercised at a price that is greater than the fair value of the
underlying instruments.
16
The portion of the Series C-21 Warrants that represent the rights to purchase Series
C-21 Preferred were valued at December 31, 2010 and September 30, 2011 using a binomial
option
pricing model, discounted for the lack of dividends until the Series C-21 Warrants are
exercised, with the following assumptions:
|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
|
September 30, |
|
|
|
2010 |
|
|
2011 |
|
Closing price per share of common stock |
|
$ |
2.60 |
|
|
$ |
0.003 |
|
Conversion price per share |
|
$ |
1.50 |
|
|
$ |
0.006 |
|
Volatility |
|
|
84.6 |
% |
|
|
80.7 |
% |
Risk-free interest rate |
|
|
2.19 |
% |
|
|
0.96 |
% |
Credit spread |
|
|
14.2 |
% |
|
|
20.1 |
% |
Remaining expected lives of underlying securities (years) |
|
|
6.3 |
|
|
|
5.0 |
|
The Series D-21 Warrants were valued at December 31, 2010 and at September 30, 2011
using a binomial option pricing model with the same assumptions used in the valuation of the Series
D-11 Warrants. The decrease in the value of the Series D-21 Warrants was
primarily due to the significant decrease in the Companys common stock price and the updates to
the assumptions used in the option pricing models, offset by the increase in the Series
D-21 Warrants by 378 units.
6. Stockholders Equity
Share-Based Compensation
In June 1994, the Company adopted the La Jolla Pharmaceutical Company 1994 Stock Incentive Plan
(the 1994 Plan), under which, as amended, 16,400 shares of common stock were authorized for
issuance. The 1994 Plan expired in June 2004 and there were 2,438 options outstanding under the
1994 Plan as of September 30, 2011.
In May 2004, the Company adopted the La Jolla Pharmaceutical Company 2004 Equity Incentive Plan
(the 2004 Plan), under which, as amended, 64,000 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, 2011, there were a total of 26,144
options outstanding under the 2004 Plan and 35,117 shares remained available for future grant.
In May 2010, the Company granted options to purchase a total of 58,000 shares of common stock to
two employees. These grants were made outside of the Companys existing stockholder-approved equity
compensation plans but were otherwise legally binding awards and did not require stockholder
approval. These stock options are treated in all respects as if granted under the Companys 2010
Equity Incentive Plan (the 2010 Plan).
In August 2010, the Company adopted the 2010 Plan under which 1,700,000 shares of common stock have
been authorized for issuance. The 2010 Plan is similar to the 2004 Plan, other than with regard to
the number of shares authorized for issuance thereunder. The 2010 Plan provides for automatic
increases to the number of authorized shares available for grant under the 2010 Plan and as such,
in May and September 2011, the number of authorized shares were increased by 3,300 and 1,600,700
shares of common stock, respectively. As of September 30, 2011, there were a total of 3,000 options
outstanding and 1,697,000 shares remained available for future grant under the 2010 Plan.
17
In August 1995, the Company adopted the La Jolla Pharmaceutical Company 1995 Employee Stock
Purchase Plan (the ESPP), under which, as amended, 48,499 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 September 30, 2011, 7,155 shares of common stock have been issued under
the ESPP and 41,344 shares of common stock are available for future issuance.
Share-based compensation expense for the three-month periods ended September 30, 2011 and 2010 was
$63,000 and $97,000, respectively and $194,000 and $402,000 for the nine months ended September 30,
2011 and 2010, respectively. As of September 30, 2011, there was $218,000 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 approximately 11 months.
The following table summarizes share-based compensation expense related to employee and director
stock options and ESPP purchases by expense category (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
General and administrative |
|
|
63 |
|
|
|
97 |
|
|
|
194 |
|
|
|
402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share-based compensation
expense included in
operating expenses |
|
$ |
63 |
|
|
$ |
97 |
|
|
$ |
194 |
|
|
$ |
402 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 employee and director stock
options granted by the Company is determined using an option-pricing model, that value may not be
indicative of the fair value observed in a willing-buyer/willing-seller market transaction.
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 and Nine Months |
|
|
|
Ended |
|
|
|
September 30, |
|
Options: |
|
2011 |
|
|
2010 |
|
Risk-free interest rate |
|
|
|
|
|
|
2.6 |
% |
Dividend yield |
|
|
|
|
|
|
0.0 |
% |
Volatility |
|
|
|
|
|
|
106.5 |
% |
Expected life (years) |
|
|
|
|
|
|
5.8 |
|
18
|
|
|
|
|
|
|
|
|
|
|
Three and Nine Months |
|
|
|
Ended |
|
|
|
September 30, |
|
ESPP: |
|
2011 |
|
|
2010 |
|
Risk-free interest rate |
|
|
|
|
|
|
0.2 |
% |
Dividend yield |
|
|
|
|
|
|
0.0 |
% |
Volatility |
|
|
|
|
|
|
90.5 |
% |
Expected life (months) |
|
|
|
|
|
|
3 |
|
There were no option grants during the three and nine months ended September 30, 2011 or during the
three months ended September 30, 2010. The weighted-average fair value of options granted for the
nine months ended September 30, 2010 was $4.48. For the ESPP, there were no purchases under the
ESPP for the three and nine months ended September 30, 2011 or for the three monts ended September
30, 2010. The weighted-average fair value for purchases under the ESPP for the nine months ended
September 30, 2010 was $2.21.
A summary of the Companys stock option activity and related data for the nine months ended
September 30, 2011 follows:
|
|
|
|
|
|
|
|
|
|
|
Outstanding Options |
|
|
|
|
|
|
|
Weighted- |
|
|
|
Number |
|
|
Average |
|
|
|
of Shares |
|
|
Exercise Price |
|
Balance at December 31, 2010 |
|
|
98,015 |
|
|
$ |
203.70 |
|
Granted |
|
|
|
|
|
$ |
|
|
Forfeited / Expired |
|
|
(8,433 |
) |
|
$ |
443.38 |
|
|
|
|
|
|
|
|
|
Balance at September 30, 2011 |
|
|
89,582 |
|
|
$ |
181.14 |
|
|
|
|
|
|
|
|
|
Restricted Stock Units
Under the 2004 Plan, the Company granted 20,209 restricted stock units (RSUs) to the Companys
three employees on December 31, 2009, where each RSU represents a contingent right to receive one
share of the Companys common stock. The RSUs were to vest upon the closing of a proposed merger
with a third party (the Merger), subject to the continued employment of the recipient through the
closing date of the Merger. As a result of the termination of the Merger in March 2010, the RSUs
were cancelled.
Stock-based compensation cost of RSUs is measured by the market value of the Companys common stock
on the date of grant. The grant date intrinsic value of awards granted is amortized on a
straight-line basis over the requisite service periods of the awards, which are the vesting
periods. The weighted average grant date intrinsic value was $17.00 per RSU. Due to their
cancellation, no stock-based compensation expense related to the RSUs was recognized during the
three and nine months ended September 30, 2010.
A summary of the Companys RSU activity and related data follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted- |
|
|
|
|
|
|
|
Average |
|
|
|
|
|
|
|
Grant Date |
|
|
|
Number of |
|
|
Fair Value |
|
|
|
Shares |
|
|
per Share |
|
Restricted stock units outstanding at December 31, 2009 |
|
|
20,209 |
|
|
$ |
17.00 |
|
Cancelled |
|
|
(20,209 |
) |
|
$ |
17.00 |
|
|
|
|
|
|
|
|
|
Restricted stock units outstanding at September 30, 2010 |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
19
7. Retention Payments
On December 4, 2009, the Company entered into Retention and Separation Agreements and General
Release of All Claims (the Retention Agreements) with its Chief Executive Officer and Vice
President of Finance who has since been appointed as the Companys Chief Financial Officer (the
Officers). The Retention Agreements superseded the severance provisions of the employment
agreements with the Officers that were effective prior to the signing of the Retention Agreements
(the Prior Employment Agreements), but otherwise the terms of the Prior Employment Agreements
remained in full force and effect. The Retention Agreements did not alter the amount of severance
that was to be awarded under the Prior Employment Agreements, but rather changed the events that
triggered such payments.
Pursuant to the Retention Agreements, on December 18, 2009 the Company paid a total of $269,000,
less applicable withholding taxes, to the Officers (the Retention Payments). If the Officers were
to voluntarily resign their employment prior to the earlier to occur of (a) the closing of the
proposed Merger and (b) March 31, 2010, they were to immediately repay the Retention Payments to
the Company. The date under (a) and (b) is referred to as the Separation Date. Neither of the
Officers resigned prior to March 31, 2010 and the Merger never closed, so each Officer was entitled
to keep the full amount of her respective Retention Payment.
Under the Retention Agreements, each of the Officers agreed to execute an amendment to the
Retention Agreements (the Amendment) on or about the Separation Date to extend and reaffirm the
promises and covenants made by them in the Retention Agreements through the Separation Date. The
Retention Agreements provided for severance payments totaling $538,000, less applicable withholding
taxes (the Severance Payments), payable in a lump sum on the eighth day after the Officers signed
the Amendment.
In April 2010, the Compensation Committee of the Board confirmed that, pursuant to the terms of the
Retention Agreements, the Retention Payments and Severance Payments were earned as of March 31,
2010 and agreed that the existing employment terms would remain in effect beyond March 31, 2010.
The Retention Payments of $269,000 that were paid in December 2009 were fully earned as of March
31, 2010, of which $222,000 was charged to general and administrative expense for the quarter ended
March 31, 2010. The fully-earned Severance Payments, including related employer taxes, of $550,000,
were paid during the quarter ended June 30, 2010. Of the $550,000 that was paid as of June 30,
2010, $456,000 was charged to general and administrative expense for the quarter ended March 31,
2010.
As an incentive to retain the Officers and an additional employee to pursue a strategic transaction
such as a financing, merger, license agreement, third party collaboration or wind down of the
Company, in April 2010, the Compensation Committee approved retention bonuses for a total of up to
approximately $600,000, depending on the type of strategic transaction completed (Strategic
Transaction Bonus). Upon the closing of the financing in May 2010, the officers and an additional
employee were paid a Strategic Transaction Bonus totaling $296,000 which was charged to general and
administrative expense for the quarter ended June 30, 2010.
8. 401(k) Plan
In September 2010, the Company adopted the La Jolla Pharmaceutical Company Retirement Savings Plan
(the 401(k) Plan), which qualifies under Section 401(k) of the Internal Revenue Code of 1986, as
amended (the Code). The 401(k) Plan is a defined contribution plan established to provide
retirement benefits for employees and is employee funded up to an elective annual deferral. The
401(k) Plan is available for all employees who have completed one year of service with the Company.
Following guidance in IRS Notice 98-52 related to the safe harbor 401(k) plan method, non-highly
compensated employees will receive a contribution from the Company equal to 3% of their annual
salaries, as defined in the Code. Such contributions vest immediately and are paid annually
following each year end. These safe harbor contributions by the Company were less than $1,500 for
the nine months ended September 30, 2011.
20
9. Net Income (Loss) per Share
The following table sets forth the computation of basic and diluted EPS (in thousands, except per
share amounts):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2011 |
|
|
2010 |
|
|
2011 |
|
|
2010 |
|
Numerator |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
3,570 |
|
|
$ |
(222 |
) |
|
$ |
1,775 |
|
|
$ |
(5,093 |
) |
Preferred stock dividends
forfeited (earned) |
|
|
(3 |
) |
|
|
(247 |
) |
|
|
75 |
|
|
|
(334 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for basic EPS net
income (loss) attributable to
common stockholders |
|
|
3,567 |
|
|
|
(469 |
) |
|
|
1,850 |
|
|
|
(5,427 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Effect of dilutive securities: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock dividends |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Numerator for diluted EPS net
income (loss) attributable to
common stockholders |
|
$ |
3,567 |
|
|
$ |
(469 |
) |
|
$ |
1,850 |
|
|
$ |
(5,427 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic EPS |
|
|
53,341 |
|
|
|
947 |
|
|
|
22,418 |
|
|
|
793 |
|
Effect of dilutive convertible
preferred stock and warrants |
|
|
1,234,659 |
|
|
|
|
|
|
|
4,847,163 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Denominator for diluted EPS |
|
|
1,288,000 |
|
|
|
947 |
|
|
|
4,869,581 |
|
|
|
793 |
|
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic EPS |
|
$ |
0.07 |
|
|
$ |
(0.49 |
) |
|
$ |
0.08 |
|
|
$ |
(6.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted EPS |
|
$ |
0.00 |
|
|
$ |
(0.49 |
) |
|
$ |
0.00 |
|
|
$ |
(6.84 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
At September 30, 2011, potentially dilutive securities of approximately 129,000 shares reserved for
the exercise of outstanding stock options and warrants for common stock were excluded from the
diluted EPS computation because their effect was anti-dilutive.
Because the Company had incurred a net loss for the three and nine months ended September 30, 2010,
common stock issuable upon the conversion of preferred stock and the exercise of stock options and
warrants were not included in the computation of net loss per share because their effect was
anti-dilutive. At September 30, 2010, potentially dilutive securities were approximately 5.2
billion shares reserved for the conversion of convertible preferred stock, including accrued
dividends, and the exercise of outstanding stock options and warrants.
The Series C-11 Preferred was convertible into 857 million and 909 million shares of
common stock at September 30, 2011 and 2010, respectively.
10. Commitments and Contingencies
As of September 30, 2011, there were no material operating leases, notes payable, purchase
commitments or capital leases.
The Company maintains its operations in a temporary space under a short-term arrangement and
expects that it will transition to permanent space under a long-term lease if and when a Strategic
Transaction is consummated.
21
|
|
|
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. Accordingly, you should not rely upon forward-looking statements
as predictions of future events. The outcome of the events described in these forward-looking
statements are subject to the risks, uncertainties and other factors described in Managements
Discussion and Analysis of Financial Condition and Results of Operations and in the Risk Factors
contained in our Annual Report on Form 10-K for the year ended December 31, 2010, and in other
reports and registration statements that we file with the Securities and Exchange Commission from
time to time and as updated in Part II, Item 1A. Risk Factors contained in this Quarterly Report
on Form 10-Q. We expressly disclaim any intent to update forward-looking statements.
Overview and Recent Developments
Since our inception in May 1989, we have devoted substantially all of our resources to the
research and development of technology and potential drugs to treat antibody-mediated diseases. We
have never generated any revenue from product sales and have relied on public and private offerings
of securities, revenue from collaborative agreements, equipment financings and interest income on
invested cash balances for our working capital.
In March 2011, we acquired the rights to RIL compounds (the Compounds) from privately held
GliaMed, Inc. (GliaMed). The RIL technology was acquired pursuant to an asset purchase agreement
(Asset Agreement) for a nominal amount, and if certain milestones noted below were met, GliaMed
would have been eligible to receive additional consideration consisting of up to 8,205 shares of
newly designated Series E Convertible Preferred Stock (Series E Preferred), which would have been
convertible into approximately 20% of the Companys fully diluted outstanding common stock on an
as-converted basis. The issuance of the shares was tied to the achievement of certain development
and regulatory milestones. GliaMed would have also been eligible for a potential cash payment if a
Compound was approved by the FDA or EMA in two or more clinical indications.
Also in March 2011, we entered into a Consent and Amendment Agreement (the Consent
Agreement), with certain holders of our convertible redeemable Series C-1 preferred stock (Series
C-1 Preferred), in order to amend certain terms of the Companys Securities Purchase
Agreement, dated as of May 24, 2010 (Securities Purchase Agreement). The purpose of the Consent
Agreement was to revise certain terms of the Companys outstanding preferred securities in
connection with the Companys acquisition of the Compounds. Additionally, as part of the Consent
Agreement, the Company designated five new series of preferred stock: its Series C-11
Convertible Preferred Stock (Series C-11 Preferred), Series C-21
Convertible Preferred Stock (Series C-21 Preferred), Series D-11
Convertible Preferred Stock (Series D-11 Preferred), Series D-21
Convertible Preferred Stock (Series D-21 Preferred and collectively with the Series
C-11 Preferred, the Series C-21 Preferred and the Series D-11
Preferred, the New Preferred Stock) and Series E Preferred. The Company exchanged on a
one-for-one basis each share of its existing Series C-1 Preferred that was outstanding for a new
share of Series C-11 Preferred (see Note 5). Unless otherwise indicated, references
herein to
22
Series C-11 Preferred reflect the one-for-one exchange. Under the Consent
Agreement, the holders agreed to the following, among other changes: (i) a temporary suspension of dividends on
Series C-11 Preferred and Series C-21 Preferred (together with the Series
C-11 Preferred, the Series C1 Preferred), (ii) to provide an additional
cash payment of $0.2 million in exchange for the right to receive Series C-21 Preferred
upon the achievement of certain pre-specified results in the preclinical study of one of the
Compounds (the Preclinical Milestone), (iii) to increase the warrants that must be exercised for
cash from 10,268 to 10,646 units, (iv) the mandatory exercise of $7.4 million of such warrants upon
the achievement of the Preclinical Milestone, (v) the mandatory exercise of the remaining $3.2
million of warrants upon the achievement of a future clinical milestone and (vi) an automatic
one-time downward conversion price adjustment following the reverse stock split.
Following the acquisition of the Compounds, we initiated a confirmatory preclinical animal
study in April 2011 studying the lead RIL compound, LJP1485. This study was completed in May 2011,
after which we received final data from Charles River Laboratories, our clinical research
organization (the CRO), which showed that the predetermined study endpoints, as set forth on the
Asset Agreement, were not met and that the LJP1485 compound did not show statistically significant
improvement in the study endpoints as compared to vehicle (placebo).
Pursuant to the Consent Agreement, our existing holders of Series C-11 Preferred
(the Preferred Stockholders) were not required to exercise their cash warrants (the Cash
Warrants) due to the failure of the LJP1485 study. The Preferred Stockholders elected to not
exercise the Cash Warrants, which then provided GliaMed with the right to reacquire the Compounds
through the purchase of the outstanding capital stock of Jewel Merger Sub, Inc. (which held title
to the Compounds) for the same nominal consideration that GliaMed received at the closing of our
acquisition of the Compounds.
On June 30, 2011, we entered into an Amendment Agreement with certain holders of our Series
C-11 Preferred (the Holders) in order to provide us with additional working capital to
allow us to more fully evaluate additional product acquisition or in-licensing opportunities. The
Holders agreed to waive the dividends on their shares of Series C-11 Preferred for the
period from June 1, 2011 to August 31, 2011 and agreed to provide us with additional working
capital by July 29, 2011, in an amount to be determined. In addition, our two executive officers
agreed to a temporary reduction in their salaries and work hours from July 1, 2011 to August 31,
2011. As of August 24, 2011, no additional working capital had been contributed to us.
On August 24, 2011, we entered into a Second Amendment Agreement with the Holders in order to
provide us with additional working capital to allow us to continue to evaluate additional product
acquisition or in-licensing opportunities that are currently being investigated. The Holders agreed
to extend the waived dividends and the two executive officers agreed to extend the temporary
reduction in their salaries and work hours through October 31, 2011. The Company is in the process of negotiating a third amendment to extend the terms of the Amendment Agreement. The Holders also agreed to
provide us with additional working capital, in an amount to be determined, by September 2, 2011 and
then again by September 26, 2011, if as of such dates, we were continuing to pursue a Strategic
Transaction. In September 2011, in accordance with the Consent Agreement, certain of the Holders
agreed to waive the preferred stock conversion limits and converted 25 shares of Series
C1 Preferred into common stock. The conversion reduced the redemption value of the
Series C-11 Preferred by $25,000 and therefore increased working capital by the same
amount. The dividends waived from June 1, 2011 through October 31, 2011 are referred to as the
Waived Dividend.
Since we did not consummate a strategic transaction (as defined in the Securities Purchase
Agreement) by the February 26, 2011 deadline under the Securities Purchase Agreement (a Strategic
Transaction), as of September 30, 2011, the outstanding preferred stockholders have the right to
demand redemption of approximately $5.1 million of Series C-11 Preferred, although such
redemption is not currently considered probable because our search for a drug candidate to develop
is ongoing.
23
Our current business operations are focused on maximizing the value of our assets and
utilizing the expertise of our management team and Board of Directors to identify other suitable
assets for development. Strategic alternatives that we are considering may include the following:
|
|
|
Pursue potential other strategic transactions, which could include
mergers, license agreements or other collaborations, with third parties where we seek
new compounds for development and seek additional capital; and/or |
|
|
|
Develop, sell or out-license our Riquent program, although we may not
receive any significant value upon such a sale or license. |
Our stockholders previously approved a proposal that authorized our Board of Directors, in its
discretion, to effect up to two reverse splits of our outstanding common stock, par value $0.0001
per share subject to certain parameters. Pursuant to this authority, our Board of Directors
approved and implemented one such reverse stock split, which became effective as of 5:00 p.m.
(Eastern Time) on April 14, 2011, with such reverse stock split having an exchange ratio of
1-for-100 (the Reverse Stock Split). No fractional shares were issued and, instead, stockholders
received the cash value of any fractional shares that would have been issued. All common stock
shares and per share information in this report have been retroactively restated to reflect the
Reverse Stock Split.
Previously, in May 2010, we sold approximately 290,000 shares of common stock and 5,134 shares
of Series C-11 Preferred, for aggregate gross proceeds of approximately $6.0 million in
a private placement. The investors also received a three-year warrant to purchase, for cash, an
additional 10,268 shares of Series C-21 Preferred for an aggregate exercise price of
approximately $10.3 million. Until June 2011, the investors were required to exercise the warrants
and purchase the additional shares of Series C-21 Preferred under the Strategic
Transaction described above. These warrants are no longer subject to a mandatory exercise term.
The investors also received an additional three-year warrant to purchase, for cash or on a
cashless basis, an additional 5,134 shares of Series D-11 Preferred for an aggregate
exercise price of approximately $5.1 million, if exercised on a cash basis; the Company will
receive no cash proceeds and will issue fewer shares if the warrants are exercised on a cashless
basis. In addition, if the investors purchase the additional 10,268 shares of Series
C-21 Preferred that must be purchased for cash, they will receive an additional
three-year warrant to purchase, for cash or on a cashless basis, 10,268 shares of Series
D-21 Preferred on the same terms as provided in the cashless warrants issued at the
initial close. The Series D-11 Preferred and Series D-21 Preferred are
collectively referred to as Series D1 Preferred.
In March 2011, the Company and the investors mutually agreed to increase both the warrants for
Series C-21 Preferred that must be purchased for cash and the additional three-year
warrants for Series D-21 Preferred from 10,268 to 10,646 shares each of preferred stock
for an additional $0.4 million in exercise proceeds.
Each share of New Preferred Stock was initially convertible into shares of our common stock at
a conversion rate of 667 shares of common stock per share of preferred stock that is converted;
effective May 7, 2011, this conversion rate increased to 166,667 shares pursuant to a one-time
adjustment that was made following the Reverse Stock Split. The Series C1 Preferred will
bear a dividend of 15% per annum, payable semi-annually in additional shares of convertible
preferred stock. The holders of Series C-11 Preferred can demand redemption. The Company
is required to obtain the vote of the holders of the New Preferred Stock prior to taking certain
corporate actions and, until April 2011, had also agreed to certain limitations on spending.
24
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations are based on
our unaudited condensed consolidated financial statements, which have been prepared in accordance
with United States generally accepted accounting principles. The preparation of these unaudited
condensed 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. 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.
The fair value of our derivative liabilities is estimated using option pricing models that are
based on the individual characteristics of the common stock and preferred stock, the derivative
liability on the valuation date, probabilities related to our operations and potential clinical
development (based on industry data), as well as assumptions for volatility, remaining expected
life, risk-free interest rate and, in some cases, credit spread. The option pricing models of our
derivative liabilities are estimates and are sensitive to changes to certain inputs used in the
options pricing models. To better estimate the fair value of our derivative liabilities at each
reporting period, the binomial option pricing models and their inputs were refined based on
information available to the Company. Such changes did not have a significant impact on amounts
recorded in previous interim reporting periods.
There have been no material changes to the critical accounting policies as previously
disclosed in our Annual Report on Form 10-K for the year ended December 31, 2010 filed on April 14,
2011.
Recent Accounting Pronouncements
In May 2011, the FASB issued authoritative guidance regarding common fair value measurements
and disclosure requirements in U.S. GAAP and IFRS. This newly issued accounting standard clarifies
the application of certain existing fair value measurement guidance and expands the disclosures for
fair value measurements that are estimated using significant unobservable inputs. This guidance is
effective on a prospective basis for annual and interim reporting periods beginning after December
15, 2011. We do not expect that adoption of this standard will have a material impact on our
financial position or results of operations.
In June 2011, the FASB issued authoritative guidance regarding comprehensive income. This
newly issued accounting standard (1) eliminates the option to present the components of other
comprehensive income as part of the statement of changes in stockholders equity; (2) requires the
consecutive presentation of the statement of net income and other comprehensive income; and (3)
requires an entity to present reclassification adjustments on the face of the financial statements
from other comprehensive income to net income. The amendments do not change the items that must be
reported in other comprehensive income or when an item of other comprehensive income must be
reclassified to net income nor do the amendments affect how earnings per share is calculated or
presented. This guidance is required to be applied retrospectively and is effective for fiscal
years and interim periods beginning after December 15, 2011. As this accounting standard only
requires enhanced disclosure, the adoption of this standard will not impact our financial position
or results of operations.
25
Results of Operations
There were no revenues for the three and nine months ended September 30, 2011 and 2010.
For the nine months ended September 30, 2011, we incurred $0.2 million in research and
development expense primarily related to costs associated with the preclinical study compared to
only nominal expenses for the same period in 2010.
For the three and nine months ended September 30, 2011, general and administrative expense
decreased to $0.4 million and $1.6 million, respectively, from $0.7 million and $3.4 million for
the same periods in 2010. The decrease of $0.3 million for the three months ended September 30,
2011 as compared to the same period in 2010 is primarily the result of decreased salaries and wages
in 2011 due to the temporary reduction in salary for the CEO and CFO, as well as lower general and
patent legal fees, consulting and accounting fees, insurance premiums and board of director fees.
The decrease of $1.8 million for the nine months ended September 30, 2011 as compared to the same
period in 2010 is due to lower salaries and wages as a result of bonus incentives paid for the May
2010 financing and for retention bonuses paid in the first quarter of 2010 to the remaining
officers totalling $1.0 million and the temporary reduction in salary for the CEO and CFO combined
with a lower headcount in 2011 for a savings of $0.1 million, a decrease in consulting and
professional services of $0.5 million and a decrease in stock compensation expense of $0.2 million,
,partially offset by the $0.2 million impairment charge for the GliaMed assets.
For the three and nine months ended September 30, 2011, non-operating income as a result of
adjustments to the estimated fair value of derivative liabilities was $4.0 million and $3.3
million, respectively. The derivative liabilities issued in the May 2010 financing were remeasured
at their estimated fair value as of September 30, 2011, resulting in a net decrease in value of
$4.0 million for the three months ended September 30, 2011 primarily due to the decrease in the
price per share of our common stock, the conversion of 185 shares of Series C-11
Preferred into common stock and changes in other inputs to the valuation models used to estimate
the liabilities. This decrease in value was recorded as non-operating income. The net decrease in
the estimated fair value of derivative liabilities of $3.3 million for the nine months ended
September 30, 2011 was primarily due to the decrease in the price per share of our common stock,
the conversion of 433 shares of Series C-11 Preferred into common stock, and changes in
other inputs to the valuation models used to estimate the liabilities, offset by a downward
adjustment to the conversion price after the Reverse Stock Split in April 2011 and the increase in
the number of outstanding Series C-21 Warrants by a total of 378 units. This decrease
in value was recorded as non-operating income.
The estimated fair value of derivative liabilities upon issuance for the nine months ended
September 30, 2010 was $5.0 million. Non-operating income as a result of adjustments to the
estimated fair value of derivative liabilities for the three and nine months ended September 30,
2010 was $0.5 million and $3.5 million, respectively. The derivative liabilities issued in the May
2010 financing were remeasured at their estimated fair value as of September 30, 2010 resulting in
a decrease in value from their issuance based upon changes in the inputs to the valuation models
used to estimate the liabilities. This resulted in $0.5 million and $3.5 million of non-operating
income for the three and nine months ended September 30, 2010, respectively.
The non-operating income as a result of adjustments to the estimated fair value of derivative
liabilities is non-cash income. Accounting rules require that our derivative instruments be
adjusted to their fair values at each reporting date, which may cause us to report significant
non-cash gains or losses as our stock price moves down or up. Prior results may not be indicative
of future results.
Financing transaction costs for the nine months ended September 30, 2010 were $0.2 million.
The costs directly related to completing the May 2010 financing and were primarily comprised of
legal expenses. There were no such costs for the same period in 2011.
Other income and other expense, net, increased to $0.2 million of income for the nine months
ended September 30, 2011 from less than $0.1 million of expense for the same period in 2010. The
increase was due to reclassification of the $0.2 million received from the Preferred Stockholders
in April 2011 to miscellaneous income as a result of the failure of the preclinical study in May
2011, pursuant to the Consent Agreement.
26
Liquidity and Capital Resources
From inception through September 30, 2011, we have incurred a cumulative net loss of
approximately $426.3 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, 2011, we have raised approximately
$417.0 million in net proceeds from sales of equity securities.
At September 30, 2011, we had $5.5 million in cash as compared to $6.9 million of cash at
December 31, 2010. Of our available cash at September 30, 2011, we could be required to pay up to
$5.1 million upon the redemption of our outstanding Series C-11 Preferred. Such
redemption was not considered probable as of September 30, 2011. Our working capital was $2.9
million at September 30, 2011, as compared to $0.5 million at December 31, 2010 and is largely
driven by our derivative liability obligations which will likely change in value in the future.
The decrease in cash resulted from the use of our financial resources to fund our general corporate
operations.
In March 2011, we received funding of approximately $0.2 million from certain of our investors
to defray the costs of the confirmatory preclinical study of LJP1485. In addition, we are
preserving cash through the temporary forfeiture/waiver of dividends on our outstanding Series
C1 Preferred for the period from November 26, 2010 to October 31, 2011 (which reduces
the number of shares of Series C1 Preferred potentially subject to redemption), as well
as through temporary reductions in the salaries of our current officers.
Our history of recurring losses from operations, our cumulative net loss as of September 30,
2011, and the absence of any current revenue sources raise substantial doubt about our ability to
continue as a going concern.
In June 2011, we entered into a short-term lease for office space. No notes payable, purchase
commitments, capital leases or other material operating leases existed as of September 30, 2011.
Our current business operations are focused on using our financial resources to fund our
current obligations while we seek to continue to assess new assets for development and consider the
feasibility of the potential further development of Riquent, as described above. In the future, it
is possible that we will not have adequate resources to support continued operations and we will
need to cease operations.
Our future capital uses and requirements depend on numerous forward-looking factors. These
factors include but are not limited to the following:
|
|
|
our ability to consummate a strategic transaction such as a merger,
license agreement or other collaboration with a third party where we seek new
compounds for development and seek additional capital; and |
|
|
|
our ability to sell, out-license or otherwise develop our Riquent
program; |
There can be no assurance that we will be able to enter into any strategic transactions on
acceptable terms, if any, and our negotiating position may worsen as we continue to utilize our
existing resources.
Off-Balance Sheet Arrangements
We have no off-balance sheet arrangements that have or are reasonably likely to have a current
or future effect on our consolidated financial condition, changes in our consolidated financial
condition, expenses, consolidated results of operations, liquidity, capital expenditures or capital
resources.
27
|
|
|
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, 2011. 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 September 30, 2011, 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, 2011 that has
materially affected, or is reasonably likely to materially affect, our internal control over
financial reporting.
PART II. OTHER INFORMATION
I. RISK FACTORS RELATING TO LA JOLLA PHARMACEUTICAL COMPANY AND THE INDUSTRY IN WHICH WE OPERATE.
The risk factors presented below update the risk factors previously disclosed in our Annual Report
on Form 10-K for the year ended December 31, 2010 (the Annual Report) and in our Quarterly Report
on Form 10-Q for the quarter ended June 30, 2011. The following factors, along with those in the
documents noted above, should be reviewed carefully, in conjunction with the other information
contained in this Report and our financial statements. These factors, among others, could cause
actual results to differ materially from those currently anticipated and contained in
forward-looking statements made in this Form 10-Q and presented elsewhere by our management from
time to time. See Part I, Item 2Forward-Looking Statements.
We have only limited assets, no ongoing clinical trials and no products.
As of September 30, 2011, we had no revenue sources, an accumulated deficit of approximately $426.3
million and available cash and cash equivalents of $5.5 million, of which, at that time, up to $5.1
million could be required to be paid upon the triggering of a redemption right under our
outstanding Series C-11 Preferred including accrued dividends. We also have
no ongoing clinical trials and no approved products. Although we retain the rights to the Riquent
patent estate, the value of the estate is uncertain and has been written down under United States
generally accepted accounting principles (GAAP) to zero. Even with the money raised in the May
2010 financing and the additional funding of $0.2 million received in March 2011, we have only
limited assets available to operate and develop our business. We are utilizing the funds received
in March 2011, and a portion of the funds received in the May 2010 financing, to continue to
evaluate certain product acquisition or in-licensing opportunities that are currently being
investigated.
28
If we are not able to acquire rights to another drug candidate for development and the investors
redeem their shares of C-11 Preferred, we would have only limited cash and
would likely be forced to liquidate the Company. In that event, the funds resulting from the
liquidation of our
assets, net of amounts payable, would likely return only a small amount, if anything, to our
stockholders.
Our financial reporting is complicated and may confuse investors.
The securities we issued in the May 2010 financing have certain features that result in fair value
accounting under FASB Topic of Derivatives and Hedging. These accounting rules require that our
derivative instruments be adjusted to their fair values at each reporting date. The fair values
are based on option pricing models and require various inputs, including our stock price, which may
change from period to period. Changes in these inputs, such as increases or decreases in our stock
price, will change the value of the derivative instruments, which means that we will likely report
significant non-cash gains or losses in future periods. These non-cash gains and losses can be
very substantial each period and may result in significant period-over-period swings in our GAAP
operating results. For example, for the three and nine months ended September 30, 2011, we
recorded non-cash net gains on the fair value of our derivative instruments of approximately $4.0
million and $3.3 million, respectively. As a result, investors are cautioned to carefully read our
financial statements, the notes thereto and Managements Discussion & Analysis of Financial
Condition and Results of Operations for a more complete understanding of our operating results.
Prior results may not be indicative of future results and periods reflecting significant non-cash
income under these accounting rules would not correspond to significant positive cash flows that
investors may normally expect.
29
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Exhibit |
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Number |
|
Description |
|
10.1 |
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|
Second Amendment Agreement by and among La Jolla Pharmaceutical
Company and the undersigned parties thereto, dated as of August 24,
2011 (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 August 25, 2011 and
incorporated by reference herein. |
30
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
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La Jolla Pharmaceutical Company
|
|
Date: November 10, 2011 |
/s/ Deirdre Y. Gillespie
|
|
|
Deirdre Y. Gillespie, M.D. |
|
|
President and Chief Executive Officer
(On behalf of the Registrant) |
|
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|
|
|
/s/ Gail A. Sloan
|
|
|
Gail A. Sloan |
|
|
Chief Financial Officer and Secretary
(As Principal Financial and Accounting Officer) |
|
31