e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended March 31, 2007
OR
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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 000-28782
SPECTRUM PHARMACEUTICALS, INC.
(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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93-0979187
(I.R.S. Employer
Identification No.) |
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157 Technology Drive
Irvine, California
(Address of Principal Executive Offices)
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92618
(Zip Code) |
Registrants Telephone Number, Including Area Code: (949) 788-6700
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12B-2 of the
Exchange Act). Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of Common Stock as of the
latest practicable date:
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Class
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Outstanding at April 27, 2007 |
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Common Stock, $.001 par value
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25,670,721 |
SPECTRUM PHARMACEUTICALS, INC.
TABLE OF CONTENTS
SPECTRUM PHARMACEUTICALS, INC.
FORM 10-Q
For the Three-month period ended March 31, 2007
(Unaudited)
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
Statement Regarding Financial Information
The
unaudited condensed consolidated financial statements of Spectrum Pharmaceuticals, Inc. included
herein have been prepared by management pursuant to the rules and regulations of
the Securities and Exchange Commission. Certain information normally included in the consolidated
financial statements prepared in accordance with accounting principles generally accepted in the
United States has been condensed or omitted pursuant to such rules and regulations. However, we
believe that the disclosures are adequate to make the information presented not misleading.
We
recommend that you read the unaudited condensed consolidated financial statements included herein in
conjunction with the audited consolidated financial statements and notes thereto included in our
Annual Report on Form 10-K for the fiscal year ended December 31, 2006, filed with the Securities
and Exchange Commission on March 14, 2007.
3
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
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March 31, |
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December 31, |
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2007 |
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2006 |
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(In Thousands, Except Share and Per Share |
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Data) |
Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
153 |
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$ |
519 |
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Marketable securities |
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45,381 |
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50,178 |
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Accounts Receivable, net of allowance for doubtful accounts |
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124 |
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1,150 |
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Prepaid expenses and other current assets |
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485 |
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440 |
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Total current assets |
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46,143 |
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52,287 |
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Property and equipment, net |
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688 |
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625 |
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Other Assets |
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169 |
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205 |
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Total assets |
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$ |
47,000 |
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$ |
53,117 |
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Liabilities and Stockholders Equity |
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Current Liabilities: |
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Accounts
payable and other accrued liabilities |
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$ |
2,885 |
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$ |
2,100 |
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Accrued compensation |
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642 |
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1,008 |
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Accrued clinical study costs |
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2,803 |
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3,125 |
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Total current liabilities |
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6,330 |
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6,233 |
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Deferred revenue and other credits |
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1,027 |
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1,035 |
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Total liabilities |
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7,357 |
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7,268 |
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Commitments and Contingencies (Note 4) |
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Minority Interest |
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20 |
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20 |
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Stockholders Equity: |
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Preferred Stock, par value $0.001 per share, 5,000,000 shares authorized: |
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Series B Junior Participating Preferred Stock, 1,000,000 shares
authorized, no shares issued and outstanding |
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Series D 8% Cumulative Convertible Voting Preferred Stock, 600 shares
authorized, stated value $10,000 per share, $0.6 million aggregate
liquidation value, issued and outstanding 49 shares at March 31, 2007
and December 31, 2006 |
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233 |
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233 |
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Series E Convertible Voting Preferred Stock, 2,000 shares authorized,
stated value $10,000 per share, $2.0 million aggregate liquidation
value, issued and outstanding, 170 shares at March 31, 2007 and
December 31, 2006 |
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1,048 |
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1,048 |
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Common stock, par value $0.001 per share, 100,000,000 shares authorized: |
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Issued and outstanding, 25,325,286 and 25,217,793 shares at March
31, 2007 and December 31, 2006, respectively |
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25 |
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25 |
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Additional paid-in capital |
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253,465 |
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251,880 |
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Accumulated other comprehensive income |
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458 |
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357 |
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Accumulated deficit |
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(215,606 |
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(207,714 |
) |
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Total stockholders equity |
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39,623 |
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45,829 |
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Total liabilities and stockholders equity |
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$ |
47,000 |
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$ |
53,117 |
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The accompanying notes are an integral part of these
condensed consolidated balance sheets.
4
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Three-Months |
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Three-Months |
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Ended |
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Ended |
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March 31, 2007 |
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March 31, 2006 |
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(In Thousands, Except Share and Per Share |
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Data) |
Revenues |
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Licensing and milestone revenues |
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$ |
343 |
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$ |
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Total Revenues |
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$ |
343 |
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$ |
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Operating expenses: |
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Research and development |
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5,024 |
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3,723 |
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General and administrative |
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2,507 |
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1,395 |
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Stock-based charges |
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1,286 |
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1,388 |
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Total operating expenses |
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8,817 |
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6,506 |
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Loss from operations |
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(8,474 |
) |
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(6,506 |
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Other income, net |
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582 |
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631 |
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Net loss before minority interest in consolidated subsidiary |
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(7,892 |
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(5,875 |
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Minority interest in net loss of consolidated subsidiary |
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2 |
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Net loss |
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$ |
(7,892 |
) |
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$ |
(5,873 |
) |
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Basic and diluted net loss per share |
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$ |
(0.31 |
) |
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$ |
(0.25 |
) |
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Basic and diluted weighted average common shares outstanding |
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25,290,717 |
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23,626,960 |
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Supplemental Information |
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Stock-based charges Components: |
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Research and development |
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$ |
826 |
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$ |
902 |
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General and administrative |
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460 |
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486 |
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Total stock-based charges |
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$ |
1,286 |
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$ |
1,388 |
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The accompanying notes are an integral part of these
condensed consolidated balance sheets.
5
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Three-Months |
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Three-Months |
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Ended |
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Ended |
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March 31, 2007 |
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March 31, 2006 |
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(In Thousands, Except Share and Per Share Data) |
Cash Flows From Operating Activities: |
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Net loss |
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$ |
(7,892 |
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$ |
(5,873 |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation and amortization |
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53 |
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48 |
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Stock-based compensation |
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1,286 |
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1,388 |
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Minority interest in subsidiary |
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(2 |
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Changes in operating assets and liabilities: |
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Decrease in Accounts Receivable |
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1,026 |
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50 |
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Decrease in other assets |
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8 |
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70 |
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Increase in accounts payable and accrued expenses |
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432 |
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980 |
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Decrease in accrued compensation and related taxes |
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(366 |
) |
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(286 |
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Decrease in deferred revenue and other credits |
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(8 |
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(21 |
) |
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Net cash used in operating activities |
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(5,461 |
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(3,646 |
) |
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Cash Flows From Investing Activities: |
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(Purchases) Sales of marketable securities |
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4,881 |
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(19,922 |
) |
Purchases of property and equipment |
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(116 |
) |
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(102 |
) |
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Net cash provided by (used in) investing activities |
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4,765 |
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(20,024 |
) |
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Cash Flows From Financing Activities: |
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Proceeds from exercise of warrants |
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330 |
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Net cash provided by financing activities |
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330 |
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Net increase (decrease) in cash and cash equivalents |
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(366 |
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(23,670 |
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Cash and cash equivalents, beginning of period |
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519 |
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28,750 |
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Cash and cash equivalents, end of period |
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$ |
153 |
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$ |
5,080 |
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Supplemental Cash Flow Information: |
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Interest paid |
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$ |
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$ |
3 |
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Income taxes paid |
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$ |
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$ |
1 |
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Schedule of Non-Cash Investing and Financing Activities: |
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Fair value of restricted stock granted employees and directors |
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$ |
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$ |
338 |
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Fair value of warrants issued to consultants and placement agents |
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$ |
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$ |
229 |
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Fair value of stock issued to match employee 401k contributions |
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$ |
31 |
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$ |
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Preferred stock dividends paid with common stock |
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$ |
10 |
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$ |
29 |
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The accompanying notes are an integral part of these
condensed consolidated balance sheets.
6
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
1. Business and Basis of Presentation
Business
Spectrum Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company engaged in the
business of acquiring and advancing a diversified portfolio of drug candidates, with a focus on
oncology, urology and other critical health challenges for which there are few other treatment
options. Our expertise lies in identifying undervalued drugs with demonstrated safety and efficacy,
and adding value through further clinical development and selection of the most viable methods of
commercialization.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements are prepared on a
consistent basis in accordance with accounting principles generally accepted in the United States
(GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of
Regulation S-X. Accordingly, they do not include all of the information and footnotes required by
GAAP for complete financial statements. In the opinion of management, all adjustments (consisting
of normal recurring accruals and consolidation and elimination entries) considered necessary for a
fair presentation have been included. Operating results for the three-month period ended March 31,
2007 are not necessarily indicative of the results that may be expected for the year ending
December 31, 2007. The balance sheet at December 31, 2006 has been derived from the audited
financial statements at that date but does not include all of the information and footnotes
required by GAAP for complete financial statements. For further information, refer to the
consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K
for the year ended December 31, 2006.
2. Summary of Significant Accounting Policies and Estimates
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and of our
wholly-owned and majority-owned subsidiaries. As of March 31, 2007, we had two subsidiaries: NeoJB
LLC (NeoJB), 80% owned, organized in Delaware in April 2002 and Spectrum Pharmaceuticals GmbH,
wholly-owned inactive subsidiary, incorporated in Switzerland in April 1997. We have eliminated all
significant intercompany accounts and transactions.
Investments by outside parties in our consolidated subsidiary are recorded as Minority
Interest in Consolidated Subsidiary in our accounts, and stated net after allocation of income and
losses in the subsidiary.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the
reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent
obligations in the financial statements and accompanying notes. Our most significant assumptions
are employed in estimates used in determining values of financial instruments and accrued
obligations, as well as in estimates used in applying the revenue recognition policy and estimating
stock-based charges. The estimation process requires assumptions to be made about future events and
conditions, and as such, is inherently subjective and uncertain. Actual results could differ
materially from our estimates.
7
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
Fair Value of Financial Instruments
The carrying amounts of cash and cash equivalents, marketable securities, accounts receivable,
accounts payable and accrued liabilities, as reported in the balance sheets, are considered to
approximate fair value given the short term maturity and/or liquidity of these financial
instruments.
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities primarily consist of bank checking deposits,
short-term treasury securities, institutional money market funds, corporate debt and equity,
municipal obligations, including market auction debt securities, government agency notes, and
certificates of deposit. We classify highly liquid short-term investments, with insignificant
interest rate risk and maturities of 90 days or less at the time of acquisition, as cash and cash
equivalents. Other investments, which do not meet the above definition of cash equivalents, are
classified as either held-to-maturity or available-for-sale marketable securities, in
accordance with the provisions of Financial Accounting Standards Board (FASB) Statement (SFAS) No.
115, Accounting for Certain Investments in Debt and Equity Securities. Investments that we intend
to hold for more than one year are classified as long-term investments.
Concentrations of Credit Risk
All of our cash, cash equivalents and marketable securities are invested at two major
financial institutions. To a limited degree these investments are insured by the Federal Deposit
Insurance Corporation (FDIC) and by third party insurance. However, these investments are not
insured against the possibility of a complete loss of earnings or principal and are inherently
subject to the credit risk related to the credit worthiness of the underlying issuer. We believe
that such risks are mitigated because we invest only in investment grade securities. We have not
incurred any significant credit risk losses related to such investments.
Patents and Licenses
We own or license all the intellectual property that forms the basis of our business model. We
expense all licensing and patent application costs as they are incurred.
Revenue Recognition
We follow the provisions as set forth by current accounting rules, which primarily include
Staff Accounting Bulletin (SAB) 104, Revenue Recognition, and Emerging Issues Task Force (EITF)
No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. Generally, revenue is
recognized when evidence of an arrangement exists, delivery has occurred or services have been
rendered, the price is fixed and determinable, and collectibility is reasonably assured.
Up-front fees representing non-refundable payments received upon the execution of licensing or
other agreements are recognized as revenue upon execution of the agreements where we have no
significant future performance obligations and collectibility of the fees is reasonably assured.
Milestone payments, which are generally based on developmental or regulatory events, are recognized
as revenue when the milestones are achieved, collectibility is reasonably assured, and we have no
significant future performance obligations in connection with the milestone. In those instances
where we have collected fees or milestone payments but have significant future performance
obligations related to the development of the drug product, we record deferred revenue and
recognize it over the period of our future obligations.
Revenue from sales of product is recognized upon shipment of product when title and risk of
loss have transferred to the customer, and provisions for estimates, including promotional
adjustments, price adjustments, returns, and other potential adjustments are reasonably
determinable. Such revenue is recorded, net of such estimated provisions, at the minimum amount of
the customers obligation to us. We state the related accounts receivable at net realizable value,
with any allowance for doubtful accounts charged to general operating expenses.
Research and Development
Research and development expenses are comprised of the following types of costs incurred in
performing research and development activities: personnel expenses, facility costs, contract
services, license fees and milestone payments, costs of clinical trials, laboratory supplies and
drug products, and allocations of corporate costs. We
8
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
expense
all research and development activity costs in the period incurred.
We review and accrue clinical study expenses based on factors such as estimates of work performed,
patient enrollment, completion of patient studies and other events. Accrued clinical study costs
are subject to revisions as trials progress to completion. Revisions are charged to expense in the
period in which the facts that give rise to the revision become known.
Basic and Diluted Net Loss Per Share
In accordance with FASB Statement No. 128, Earnings Per Share, we calculate basic and diluted
net loss per share using the weighted average number of common shares outstanding during the
periods presented, and adjust the amount of net loss, used in this calculation, for preferred stock
dividends declared during the period.
We incurred a net loss in each period presented, and as such, did not include the effect of
potentially dilutive common stock equivalents in the diluted net loss per share calculation, as
their effect would be anti-dilutive for all periods. Potentially dilutive common stock equivalents
would include the common stock issuable upon the conversion of preferred stock and the exercise of
warrants and stock options that have conversion or exercise prices below the market value of our
common stock at the measurement date. As of March 31, 2007 and 2006, all potentially dilutive
common stock equivalents amounted to approximately 16 million and 15 million shares, respectively.
The following data show the amounts used in computing basic loss per share for the three-month
periods ended March 31, 2007 and 2006.
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Three-Months |
|
Three-Months |
|
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Ended |
|
Ended |
|
|
March 31, 2007 |
|
March 31, 2006 |
|
|
(In Thousands, Except Share and Per |
|
|
Share Data) |
Net loss |
|
$ |
(7,892 |
) |
|
$ |
(5,873 |
) |
Less: |
|
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|
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|
Preferred dividends paid in cash or stock |
|
|
(10 |
) |
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|
(29 |
) |
|
|
|
Income available to common stockholders
used in computing basic earnings per
share |
|
$ |
(7,902 |
) |
|
$ |
(5,902 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
25,290,717 |
|
|
|
23,626,960 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.31 |
) |
|
$ |
(0.25 |
) |
|
|
|
Accounting for Stock-Based Employee Compensation
Effective
January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment, using the
modified prospective method and, accordingly, did not restate the consolidated statements of
operations for periods prior to January 1, 2006. This pronouncement amended SFAS No. 123,
Accounting for Stock-Based Compensation, and superseded Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees. Under SFAS No. 123(R), we measure compensation
cost for all stock-based awards at fair value on the date of grant and recognize compensation
expense in our consolidated statements of operations over the service period that the awards are
expected to vest. As permitted under SFAS No. 123(R), we have elected to recognize compensation
cost for all options with graded vesting on a straight-line basis over the vesting period of the
entire option.
In estimating the fair value of stock-based compensation, we use the quoted market price of
our common stock for stock awards, and the Black-Scholes Option Pricing Model for stock options and
warrants. We estimate future volatility based on past volatility of our common stock, and we
estimate the expected length of options based on several criteria, including the vesting period of
the grant and the expected volatility.
9
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
Comprehensive Loss
The net loss reflected on our Consolidated Statements of Operations substantially represents
the total comprehensive loss for the periods presented.
3. Products and Strategic Alliances
Our key products under development that represent nearer term revenue and/or development
expense potential and related business alliances are described in detail in our Annual Report on
Form 10-K for the year ended December 31, 2006.
The following is a brief update of the most advanced products under development as of March
31, 2007:
Satraplatin: In February 2007, submission of a New Drug Application, or NDA, with the FDA was
completed; and on April 16, 2007, we announced that it was accepted by the FDA for priority review.
A Prescription Drug User Fee Act (PDUFA) date of August 15, 2007 has been established by the
FDA for a decision regarding the approval of the satraplatin application. The FDAs acceptance of
the NDA triggered a $4 million milestone payable to Spectrum and
$500,000 payable by us to Johnson Matthey.
Levofolinic acid (LFA): During the three-month period ended March 31, 2007, we continued
progression toward submitting a response, in 2007, to certain chemistry and manufacturing
questions raised by the FDA during the review of the NDA for LFA for osteogenic sarcoma.
EOquin®: In February 2007, we completed patient accrual in a pilot
safety study that was requested by the FDA. In this study, EOquin was found to be well tolerated
when administered to patients immediately following surgery for non-invasive bladder cancer in
clinical results to date. EOquin received
approval by the FDA of a Special Protocol Assessment which enables us
to initiate a Phase 3 study. The Special Protocol Assessment process
allows for an agreement between us and the FDA on the design of the study and is intended to
provide assurance that if pre-specified trial results are achieved, they may serve as the primary
basis for an efficacy claim in support of a NDA by us for EOquin.
Ozarelix: In January 2007, we initiated a Phase 2b study of ozarelix for the treatment of
benign prostatic hypertrophy, or BPH, after the FDA accepted our IND and approved the study
protocol.
4. Commitments and Contingencies
Facility and Equipment Leases
As of March 31, 2007, we were obligated under a facility lease and several operating equipment
leases.
Minimum lease requirements for each of the next five years and thereafter, under the property
and equipment operating leases, are as follows:
|
|
|
|
|
Year ending December 31: |
|
Lease Commitments |
|
|
|
Amounts In |
|
|
|
Thousands |
|
2007 (Remainder of Year) |
|
$ |
357 |
|
2008 |
|
|
494 |
|
2009 |
|
|
253 |
|
2010 |
|
|
5 |
|
2011 |
|
|
|
|
Thereafter |
|
|
|
|
|
|
|
|
|
|
$ |
1,109 |
|
|
|
|
|
10
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
Licensing Agreements
Almost all of our proprietary drug product candidates are being developed pursuant to license
agreements, which provide us with rights to certain territories to, among other things, develop,
sublicense, and sell the drugs. With regard to one of our proprietary drug product candidates,
satraplatin, we have out-licensed our rights to GPC Biotech. We are required to use commercially
reasonable efforts to develop the drugs, are generally responsible for all development, patent
filing and maintenance costs, sales, marketing and liability insurance costs, and are generally
contingently obligated to make milestone payments to the licensors if we successfully reach
development and regulatory milestones specified in the agreements. In addition, we are obligated to
pay royalties and, in some cases, milestone payments based on net sales, if any, after marketing
approval is obtained from regulatory authorities. We have no similar milestone or other payment
obligations in connection with our generic drug products, however,
Par Pharmaceutical Companies, Inc. is responsible for marketing
our generic sumatriptan injection product and we will share the profits.
The potential contingent development and regulatory milestone obligations under all our
licensing agreements are generally tied to progress through the FDA approval process, which
approval significantly depends on positive clinical trial results. The following list is typical of
milestone events: conclusion of Phase 2 or commencement of Phase 3 clinical trials, filing of new
drug applications in each of the United States, Europe and Japan, and approvals from each of the
regulatory agencies in those jurisdictions.
Given the uncertainty of the drug development process, we are unable to predict with any
certainty when any of the milestones will occur. Accordingly, the milestone payments represent
contingent obligations that will be recorded as expense when the milestone is achieved. In
connection with the development of in-licensed drug products, we anticipate certain milestones will
be achieved over the next twelve months. If the anticipated milestones are achieved, we will likely
become obligated to issue up to 330,000 shares of our common stock and pay up to approximately $4
million in cash during the twelve-month period and will simultaneously have the right to receive
approximately $10 million from the same milestones. If all of our contingent milestones were
achieved, our potential contingent cash development and regulatory milestone obligations,
aggregating approximately $48 million as of March 31, 2007, would be due approximately as follows:
$4 million in less than 1 year; $3 million between 1 and 3 years; $20 million between 3 and 5
years; and $21 million after 5 years.
Service Agreements
In connection with the research and development of our drug products, we have entered into
contracts with numerous third party service providers, such as clinical trial centers, clinical
research organizations, data monitoring centers, and with drug formulation, development and testing
laboratories. The financial terms of these agreements are varied and generally obligate us to pay
in stages, depending on achievement of certain events specified in the agreements, such as contract
execution, reservation of service or production capacity, actual performance of service, or the
successful accrual and dosing of patients. As of each period end, we accrue for all non-cancelable
installment amounts that we are likely to become obligated to pay.
Employment Agreements
We have entered into employment agreements with two of our named executive officers, Dr.
Shrotriya, President and Chief Executive Officer, and Dr. Lenaz, Chief Scientific Officer, expiring
December 31, 2007 and July 1, 2008, respectively. The employment agreements automatically renew for
a one-year term unless either party gives written notice of such partys intent not to renew the
agreement at least 90 days prior to the commencement of the next year. The employment agreements
require each officer to devote his full working time and effort to the business and affairs of the
Company during the term of the agreement. The employment agreements provide for a minimum annual
base salary with annual increases, periodic bonuses and option grants as determined by the
Compensation Committee of the Board of Directors and provide for
severance payments, and accelerated vesting of options, upon
termination of employment under certain circumstances.
11
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
Litigation
At March 31, 2007, we were in dispute with GPC Biotech. In December 2006, we filed a demand
for arbitration to address our exclusion from participating in
sublicense income received by GPC Biotech, and to other
non-monetary violations of our license agreement with GPC Biotech, and GPC Biotech answered and counterclaimed. The three arbitration panel members have been selected
and have met. We are currently in fact discovery. The arbitration hearing has been set for July 6
to July 13, 2007 and will take place in Boston, Massachusetts.
It is not possible to determine with any degree of
certainty the ultimate outcome of the arbitration. Since an adverse outcome is considered to be
remote, no loss contingency has been recorded in the accompanying financial statements. Conversely, no gain contingency has been
recorded in the event we are successful in our demands.
12
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
We are party to various other legal proceedings arising from the ordinary course of business.
Although the ultimate resolution of these various proceedings cannot be determined at this time, we
do not believe that such proceedings, individually or in the aggregate, will have a material
adverse effect on our future consolidated results of operations, cash flows or financial condition.
5. Stockholders Equity
Common Stock Reserved for Future Issuance
As of March 31, 2007, approximately 16 million shares of common stock were issuable upon
conversion or exercise of rights granted under prior financing arrangements and stock options and
warrants, as follows:
|
|
|
|
|
Conversion of Series D preferred shares |
|
|
204,891 |
|
Conversion of Series E preferred shares |
|
|
340,000 |
|
Exercise of stock options |
|
|
5,302,352 |
|
Exercise of warrants |
|
|
9,782,747 |
|
|
|
|
|
|
|
|
|
|
Total shares of common stock reserved for future issuances |
|
|
15,629,990 |
|
|
|
|
|
Stock-Based Compensation
As of March 31, 2007, approximately 1.9 million incentive awards were available for grant
under our stock-based incentive award plans. Stock-based awards generally vest over periods up to
four years and have a ten-year life.
Below is a summary of activity, for all of our stock-based incentive award plans, during the
three-month period ended March 31, 2007:
Stock Options:
During the three-month period ended March 31, 2007, the Compensation Committee granted stock
options at exercise prices equal to or greater than the quoted price of our common stock on the
grant dates. The weighted average grant date fair value of stock options granted during the quarter
ended March 31, 2007 was estimated at approximately $3.46, using the Black-Scholes option pricing
model with the following assumptions: dividend yield of 0%; expected volatility of 67.9%; risk free
interest rate of 4.7%; and an expected life of five years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
Common |
|
Average |
|
Weighted |
|
Aggregate |
|
|
Stock |
|
Exercise |
|
Average |
|
Intrinsic |
|
|
Options |
|
Price |
|
Remaining Term |
|
Value |
|
|
|
|
|
|
|
|
|
|
(In Years) |
|
(In Thousands) |
Outstanding at beginning of year |
|
|
4,640,252 |
|
|
$ |
5.86 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
662,200 |
|
|
$ |
5.73 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(100 |
) |
|
$ |
112.50 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, at the end of period |
|
|
5,302,352 |
|
|
$ |
5.84 |
|
|
|
7.74 |
|
|
$ |
5,921 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, at end
of period |
|
|
5,116,008 |
|
|
$ |
5.85 |
|
|
|
7.70 |
|
|
$ |
5,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, at the end of period |
|
|
3,438,915 |
|
|
$ |
5.91 |
|
|
|
7.14 |
|
|
$ |
4,199 |
|
|
|
|
13
SPECTRUM PHARMACEUTICALS, INC.
Notes
to Condensed Consolidated Financial Statements
March 31, 2007
(Unaudited)
The aggregate intrinsic value in the table above represents the total difference between
the Companys closing common stock price on March 31, 2007 and the exercise price, multiplied by
the number of all in-the-money options, that would have been received by the option holders had all
option holders exercised their options on March 31, 2007. This amount changes based on the fair
market value of the Companys common stock.
During the three-month period ended March 31, 2007, the stock-based charge in connection with
the expensing of stock options was $1.2 million. As of March 31, 2007, there was $6.8 million of
unrecognized stock-based compensation cost related to stock options which is expected to be
recognized over a weighted average period of 2.56 years.
Restricted Stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Restricted |
|
Average |
|
|
Stock |
|
Grant date |
|
|
Awards |
|
Fair Value |
|
|
|
Nonvested at beginning of period |
|
|
146,250 |
|
|
$ |
4.25 |
|
Granted |
|
|
|
|
|
|
|
|
Vested |
|
|
(48,750 |
) |
|
$ |
4.25 |
|
|
|
|
Nonvested at the end of period |
|
|
97,500 |
|
|
$ |
4.25 |
|
|
|
|
The fair value of restricted stock awards is the grant date quoted market price of our
stock, and is charged to expense over the period of vesting. These awards are subject to forfeiture
to the extent that the recipients service is terminated prior to the shares becoming vested.
During the three-month period ended March 31, 2007, the stock-based charge in connection with
the expensing of restricted stock awards was $50,000. As of March 31, 2007, there was $359,000 of
unrecognized stock-based compensation cost related to nonvested restricted stock awards, which is
expected to be recognized over a weighted average period of 1.76 years.
401(k) Plan Matching Contribution:
In January 2007, we issued 5,628 shares of common stock as the Companys match of
approximately $31,000 on the 401(k) contributions of its employees accrued in the fourth quarter of
2006. As of March 31, 2007, we accrued approximately $54,000 in connection with the Companys
match for 2007 through that date; and in April 2007, we issued 8,686 shares of common stock as the
Companys match.
Warrants Activity
We typically issue warrants to purchase shares of our common stock to investors as part of a
financing transaction, or in connection with services rendered by placement agents and consultants.
Our outstanding warrants expire on varying dates through September 2013. Below is a summary of
warrant activity during the three-month period ended March 31, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Common Stock |
|
Average Exercise |
|
|
Warrants |
|
Price |
|
|
|
Outstanding at beginning of period |
|
|
9,917,077 |
|
|
$ |
6.71 |
|
Granted |
|
|
|
|
|
|
|
|
Repurchased |
|
|
|
|
|
|
|
|
Exercised |
|
|
(102,263 |
) |
|
$ |
3.26 |
|
Forfeited |
|
|
|
|
|
|
|
|
Expired |
|
|
(32,068 |
) |
|
$ |
68.59 |
|
|
|
|
Outstanding, at the end of period |
|
|
9,782,747 |
|
|
$ |
6.54 |
|
|
|
|
Exercisable, at the end of period |
|
|
9,647,747 |
|
|
$ |
6.56 |
|
|
|
|
14
SPECTRUM PHARMACEUTICALS, INC.
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, in reliance upon the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding
our future product development activities and costs, the revenue potential (licensing, royalty and
sales) of our product candidates, the safety and efficacy of our drug products, the timing and
likelihood of achieving development milestones and product revenues, the sufficiency of our capital
resources, and other statements containing forward-looking words, such as, believes, may,
could, will, expects, intends, estimates, anticipates, plans, seeks, or
continues. Such forward-looking statements are based on the beliefs of the Companys management
as well as assumptions made by and information currently available to the Companys management.
Readers should not put undue reliance on these forward-looking statements. Forward-looking
statements are inherently subject to risks and uncertainties, some of which cannot be predicted or
quantified; therefore, our actual results may differ materially from those described in any
forward-looking statements. Factors that might cause such a difference include, but are not limited
to, those discussed below, including under Risk Factors as well as those discussed in our
periodic reports filed with the Securities and Exchange Commission including our Annual Report on
Form 10-K. These factors include, but are not limited to:
|
|
|
our ability to successfully develop, obtain regulatory approvals for and market our products; |
|
|
|
|
our ability to generate and maintain sufficient cash resources to fund our business; |
|
|
|
|
our ability to enter into strategic alliances with partners for manufacturing,
development and commercialization; |
|
|
|
|
our ability to identify new product candidates; |
|
|
|
|
the timing or results of pending or future clinical trials; |
|
|
|
|
competition in the marketplace for our generic drugs; |
|
|
|
|
actions by the FDA and other regulatory agencies; |
|
|
|
|
demand and market acceptance for our approved products; and |
|
|
|
|
the effect of changing economic conditions. |
We do not plan to update any such forward-looking statements and expressly disclaim any duty
to update the information contained in this report except as required by law.
You should read the following discussion of the financial condition and results of our
operations in conjunction with the condensed consolidated financial statements and the notes to those financial
statements included in Item 1 of Part 1 of this report.
Overview
We are a biopharmaceutical company that acquires and advances a diversified portfolio of drug
candidates, with a focus on oncology, urology and other critical health challenges for which there
are few other treatment options. Our expertise lies in identifying undervalued drugs with
demonstrated safety and efficacy, and adding value through further clinical development and
selection of the most viable methods of commercialization. We currently have ten drugs in
development, including five in late stage clinical development.
In general, we direct and pay for all aspects of the drug development process, and
consequently incur the risks and rewards of drug development, which is an inherently uncertain
process. To mitigate such risks we enter into alliances where we believe that our partners can
provide strategic advantage in the development, manufacturing or distribution of our drugs. In such
situations, the alliance partners may share in the risks and rewards of the drug development and
commercialization.
15
SPECTRUM PHARMACEUTICALS, INC.
Business Outlook
Our primary business focus for 2007, and beyond, will be to continue to acquire, develop and
commercialize a portfolio of marketable prescription drug products with a mix of near-term and
long-term revenue potential. Key developments anticipated in the next 12 to 18 months are:
|
|
|
Satraplatin: In February 2007, submission of an NDA with the FDA was
completed. In April 2007, the FDA accepted the NDA with priority review. This
triggered a milestone payable by our partner GPC Biotech to us of $4 million. We paid
Johnson Matthey $500,000 upon submission of the completed NDA filing and are obligated to
pay an additional $500,000 upon acceptance of the NDA by the FDA. A European marketing
application is expected to be filed in the first half of 2007. GPC Biotech has initiated
additional studies in other indications. |
|
|
|
|
Levofolinic acid, or LFA: During the three-month period ended March 31,
2007, we continued progression toward submitting a response, in 2007, to certain
chemistry and manufacturing questions raised by the FDA during the review of the NDA for
LFA for osteogenic sarcoma. |
|
|
|
|
EOquin®: In February 2007, we completed patient
accrual in a pilot safety study that was requested by the FDA. In this study, EOquin was
found to be well tolerated when administered to patients immediately following surgery
for noninvasive bladder cancer in clinical results to date. In March 2007, we received
approval by the FDA of a Special Protocol Assessment, or SPA. The EOquin SPA calls for
two double-blind, placebo-controlled, randomized Phase 3 clinical studies, each with
562-patients with Ta G1 G2 non-invasive bladder cancer. Patients will
be randomized in a one-to-one ratio to EOquin or placebo. The primary endpoint will be a
statistically significant difference (p < 0.05) in the rate of tumor recurrence
between the two treatment groups by year two. |
|
|
|
|
Ozarelix: In January 2007, the FDA accepted our IND application for
ozarelix in BPH and also approved the protocol for a Phase 2b study of ozarelix for the
treatment of BPH. The Phase 2b study is a randomized, placebo-controlled trial of
ozarelix involving approximately 75 men suffering from BPH. In this trial, the men will
be dosed with 15 mg of ozarelix or placebo on day 1 and day 15 and will be followed for
efficacy for a minimum of twelve weeks. The study will evaluate safety and assess the
clinical efficacy of ozarelix as a treatment for BPH. The primary endpoint of the study
will be the improvement of BPH symptoms as measured by the IPSS, the standard method of
assessing BPH symptoms. The study will also measure urine flow, residual urine volume
and quality of life. On May 1, we announced completion of patient enrollment in this
study. Data from this trial is expected to be available in the second half of 2007.
Safety and efficacy data from this trial will be used to support an NDA for ozarelix. We
anticipate commencing a Phase 3 clinical trial in BPH in 2007, or soon thereafter. |
|
|
|
|
Sumatriptan injection: In November 2006, we reached an agreement with GSK to
settle the patent litigation relating to sumatriptan injection. The terms of the
agreement provide that we may exclusively distribute authorized generic versions of
certain sumatriptan injection products in the United States with an expected launch
during GSKs sumatriptan pediatric exclusivity period, which begins on August 6, 2008,
but with the launch occurring not later than November 6, 2008. We will launch
sumatriptan injection through Par Pharmaceuticals Co., our partner for the sale and
distribution of the drug. |
|
|
|
|
We plan to continue to fund the development, including preclinical testing and clinical
trials, of lucanthone, elsamitrucin, RenaZorb®, SPI-1620 and SPI-205. |
|
|
|
|
We expect to continue to evaluate additional promising drug product candidates for
acquisition or license. |
16
SPECTRUM PHARMACEUTICALS, INC.
Financial Condition
Liquidity and Capital Resources
Our current business operations do not generate sufficient operating cash to finance the
clinical development of our drug product candidates. Our cumulative losses, since inception in 1987
through March 31, 2007, have exceeded $200 million. We expect to continue to incur significant
additional losses as we implement our growth strategy of developing marketable drug products for at
least the next several years unless they are offset, if at all, by licensing revenues under our
license agreement with GPC Biotech or from the out-license or product sales of any of our other
products.
We believe that the approximately $45 million in cash, cash equivalents and marketable
securities that we had on hand as of March 31, 2007, will allow us to fund our current planned
operations for at least the next twelve months. In the near-term we are likely to seek additional
capital in order to develop our portfolio of drugs. Our long-term strategy is to generate profits
from the sale and licensing of our propriety drug products. In the next several years, we
anticipate supplementing our cash position with licensing and royalties revenues under our license
agreement with GPC Biotech, licensing revenues from out-licensing our other proprietary products
and profits from the sale by Par of the authorized generic versions of certain sumatriptan
injection products.
However, if we are unable to generate the revenues necessary to finance our operations
long-term, we may have to seek additional capital through the sale of
our equity, which we may issue at any time, as appropriate. Our operations
have historically been financed by the issuance of capital stock. To this effect, we have on file a
shelf registration statement with approximately $31 million available for the sale of our
securities. In addition, we could receive a significant amount of cash from the exercise of
outstanding warrants and options, if the price of our common stock appreciates. It is generally
difficult to fund pharmaceutical research and development via borrowings due to the significant
expenses involved, lack of revenues sufficient to service debt and the significant inherent
uncertainty as to results of research and the timing of those results.
As described elsewhere in this report, including in Item 1A Risk Factors, as well as the
risk factors in our 2006 Annual Report on Form 10-K, our drug development efforts are subject to
the considerable uncertainty inherent in any new drug development. Due to the uncertainties
involved in progressing through clinical trials, and the time and cost involved in obtaining
regulatory approval and in establishing collaborative arrangements, among other factors, we cannot
reasonably estimate the timing and ultimate aggregate cost of developing each of our drug product
candidates, and are similarly unable to reasonably estimate when, if ever, we will realize material
net cash inflows from our proprietary drug product candidates. Accordingly, the following
discussion of our current assessment of the need for cash to fund our operations may prove too
optimistic and our assessment of expenditures may prove inadequate.
Our expenditures for research and development consist of direct product specific costs (such
as upfront license fees, milestone payments, active pharmaceutical ingredients, clinical trials,
patent related legal costs, and product liability insurance, among others) and non-product
specific, or indirect, costs. During the three-month period ended March 31, 2007, our total
research and development expenditure, excluding stock-based charges of approximately $826,000, was
approximately $5 million, consisting of approximately $3 million in direct costs. The principal
components of such direct expenses were direct costs related to ozarelix approximately $900,000,
EOquin approximately $800,000, a satraplatin milestone $500,000, and LFA approximately
$400,000.
While we are currently focused on advancing each of our product development programs, we
anticipate that we will make determinations as to which programs, if any, to pursue and how much
funding to direct to each program on an ongoing basis in response to the scientific and clinical
success of each product candidate, as well as an ongoing assessment as to the product candidates
commercial potential.
In addition to our present portfolio of drug product candidates, we continually evaluate
proprietary products for acquisition. If we are successful in acquiring rights to additional
products, we may pay up-front licensing fees in cash and our research and development expenditures
would likely increase.
Under our various existing licensing agreements, we are contingently obligated to make
milestone payments. In connection with the development of certain in-licensed drug products, we
anticipate the occurrence of certain of these milestones over the next twelve months. Upon
successful achievement of these milestones, we will likely become obligated to pay up to
approximately $4 million in cash and issue up to 330,000 shares of our common stock during the next
twelve months and will simultaneously have the right to receive approximately $10 million from the
same milestones.
17
SPECTRUM PHARMACEUTICALS, INC.
Net Cash used in Operating Activities
During the three-month period ended March 31, 2007, the net cash used in operations was
approximately $5.5 million, net of interest income of approximately $0.6 million.
Our anticipated use of cash for operations in fiscal 2007, excluding the cost of in-licensing
additional drugs, if any, is expected to approximate $25 million. This estimate is subject to
considerable uncertainty, and is dependent on the following key factors: approval of satraplatin by
FDA, and subsequent successful launch by GPC Biotech, continued positive results from our
preclinical studies, the final results from current phase 2 study data, the outcome of discussions
with the FDA regarding our planned phase 3 clinical trials and the initiation of clinical trials as
anticipated. Further, while we do not receive any funding from third parties for research and
development that we conduct, our estimated costs could be mitigated should we enter into
co-development agreements for any of our drug product candidates.
Net Cash provided by Investing Activities
While cash preservation is our primary investment goal, in order to maximize the interest
yield on our investments, we invest our cash in a variety of investments pending its use in our
business. During the three-month period ended March 31, 2007, we utilized Lehman Brothers as our
primary cash manager. Net cash provided by investing activities was approximately $4.8 million
during the three-month period ended March 31, 2007, and resulted primarily from conversion of
marketable securities to cash for use in operations.
Net Cash provided by and used for Financing Activities
During the three-month period ended March 31, 2007, we received approximately $333,000 from
the exercise of warrants for 102,263 shares of our common stock.
Results of Operations
Results of Operations for the three-month period ended March 31, 2007 Compared to the
three-month period ended March 31, 2006
For the three-month period ended March 31, 2007, we incurred a net loss of approximately $7.9
million compared to a net loss of approximately $5.9 million in the three-month period ended March
31, 2006. The increase of $2.0 million in the net loss was primarily due to increases in research
and development expenses, and increased legal expenses.
We had no revenues during the three-month period ended March 31, 2006. During the three-month
period ended March 31, 2007, we had $343,000 of revenues representing amounts received from the GPC
Biotech under our license agreement for commissions on drug products used by GPC Biotech in
clinical trials and for commercial launch. The timing and amount of future commissions is neither predictable nor assured.
Research and development expenses increased approximately $1.3 million, from approximately
$3.7 million in the three-month period ended March 31, 2006 to approximately $5.0 million in the
three-month period ended March 31, 2007, due to the expanded scope of our research and development
activities, including an increase in the number of personnel in preparation for the commencement of
a phase 3 trial for EOquin, which is expected to initiate shortly. Approximately $500,000 of the
increase is attributable to the payment of a milestone payable upon the filing of the NDA for
satraplatin.
General and administrative expenses increased by approximately $1.1 million, from
approximately $1.4 million in the three-month period ended March 31, 2006 to approximately $2.5
million in the three-month period ended March 31, 2007, primarily due to increased legal expenses
resulting from the dispute with GPC Biotech, described elsewhere in this report.
18
SPECTRUM PHARMACEUTICALS, INC.
Stock-based
charges changed minimally decreasing from approximately $1.4 million in the
three-month period ended March 31, 2006 to approximately $1.3 million in the three-month period
ended March 31, 2007, and represent the non-cash charges resulting from our adoption of SFAS
123(R), effective January 1, 2006.
Other income consisted of net interest income of approximately $0.6 million for each of the
three-month periods ended March 31, 2007 and March 31, 2006.
Off-Balance Sheet Arrangements
None.
Contractual and Commercial Obligations
The following table summarizes our contractual and other commitments, including obligations
under facility and equipment leases, as of March 31, 2007 (in
thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
After |
|
|
Total |
|
1 Year |
|
1-3 Years |
|
3-5 Years |
|
5 Years |
Contractual Obligations (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital Lease Obligations (2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Lease Obligations (3) |
|
$ |
1,109 |
|
|
$ |
478 |
|
|
$ |
631 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase Obligations (4) |
|
|
7,878 |
|
|
|
7,146 |
|
|
|
717 |
|
|
|
15 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Milestone Obligations (5) |
|
|
47,859 |
|
|
|
3,972 |
|
|
|
3,062 |
|
|
|
19,725 |
|
|
|
21,100 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
56,846 |
|
|
$ |
11,596 |
|
|
$ |
4,410 |
|
|
$ |
19,740 |
|
|
$ |
21,100 |
|
|
|
|
|
|
|
(1) |
|
The table of contractual and commercial obligations excludes contingent payments that we may
become obligated to pay upon the occurrence of future events whose outcome is not readily
predictable. |
|
(2) |
|
As of March 31, 2007, we had no capital lease obligations. |
|
(3) |
|
The operating lease obligations are primarily the facility lease for our corporate office,
which extends through June 2009. |
|
(4) |
|
Purchase Obligations represent the amount of open purchase orders and contractual commitments
to vendors, for products and services that have not been delivered, or rendered, as of March
31, 2007. |
|
(5) |
|
Milestone Obligations are payable contingent upon successfully reaching certain development
and regulatory milestones. While the
amounts included in the table above represent all of our potential cash development and
regulatory milestone obligations as of March 31, 2007, given the unpredictability of the drug
development process, and the impossibility of predicting the success of current and future
clinical trials, the timelines estimated above do not represent a forecast of when payment
milestones will actually be reached, if at all. Rather, they assume that all development and
regulatory milestones under all of our license agreements are successfully met, and represent
our best estimates of the timelines. In the event that the milestones are met, we believe it
is likely that the increase in the potential value of the related drug product will
significantly exceed the amount of the milestone obligation. |
19
SPECTRUM PHARMACEUTICALS, INC.
Critical Accounting Policies and Estimates
Our discussion and analysis of our financial condition and results of operations are based
upon our consolidated financial statements, which have been prepared in accordance with accounting
principles generally accepted in the United States. The preparation of these 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.
The estimation process requires assumptions to be made about future events and conditions, and as
such, is inherently subjective and uncertain. Actual results could
differ materially from our estimates. On an on-going basis, we evaluate our estimates, including cash requirements, by
assessing: planned research and development activities and general and administrative requirements,
required clinical trial activity, market need for our drug candidates and other major business
assumptions.
The SEC defines critical accounting policies as those that are, in managements view, most
important to the portrayal of our financial condition and results of operations and most demanding
of our judgment. We consider the following policies to be critical to an understanding of our
consolidated financial statements and the uncertainties
associated with the complex judgments made by us that could impact our results of operations,
financial position and cash flows.
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities primarily consist of bank checking deposits,
short-term treasury securities, and institutional money market funds, corporate debt and equity,
municipal obligations, including market auction debt securities, government agency notes, and
certificates of deposit. We classify highly liquid short-term investments, with insignificant
interest rate risk and maturities of 90 days or less at the time of acquisition, as cash and cash
equivalents. Other investments, which do not meet the above definition of cash equivalents, are
classified as either held-to-maturity or available-for-sale marketable securities, in
accordance with the provisions of Financial Accounting Standards Board, or FASB, Statement, or
SFAS, No. 115, Accounting for Certain Investments in Debt and Equity Securities. Investments that
we intend to hold for more than one year are classified as long-term investments.
Patents and Licenses
We own or license all the intellectual property that forms the basis of our business model. We
expense all licensing and patent application costs as they are incurred.
Revenue Recognition
We follow the provisions as set forth by current accounting rules, which primarily include
Staff Accounting Bulletin (SAB) 104, Revenue Recognition, and Emerging Issues Task Force (EITF)
No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. Generally, revenue is
recognized when evidence of an arrangement exists, delivery has occurred or services have been
rendered, the price is fixed and determinable, and collectibility is reasonably assured.
Up-front fees representing non-refundable payments received upon the execution of licensing or
other agreements are recognized as revenue upon execution of the agreements where we have no
significant future performance obligations and collectibility of the fees is reasonably assured.
Milestone payments, which are generally based on developmental or regulatory events, are recognized
as revenue when the milestones are achieved, collectibility is reasonably assured, and we have no
significant future performance obligations in connection with the milestone. In those instances
where we have collected fees or milestone payments but have significant future performance
obligations related to the development of the drug product, we record deferred revenue and
recognize it over the period of our future obligations.
Revenue from sales of product is recognized upon shipment of product when title and risk of
loss have transferred to the customer, and provisions for estimates, including promotional
adjustments, price adjustments, returns, and other potential adjustments are reasonably
determinable. Such revenue is recorded, net of such estimated provisions, at the minimum amount of
the customers obligation to us. We state the related accounts receivable at net realizable value,
with any allowance for doubtful accounts charged to general operating expenses.
Research and Development
Research and development expenses are comprised of the following types of costs incurred in
performing research and development activities: personnel expenses, facility costs, contract
services, license fees and milestone payments, costs of clinical trials, laboratory supplies and
drug products, and allocations of corporate costs. We expense all research and development activity
costs in the period incurred. We review and accrue clinical study expenses based on factors such as
estimates of work performed, patient enrollment, completion of patient studies
20
SPECTRUM PHARMACEUTICALS, INC.
and other events.
Accrued clinical study costs are subject to revisions as trials progress to completion. Revisions
are charged to expense in the period in which the facts that give rise to the revision become
known.
Accounting for Stock-Based Employee Compensation
Effective
January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment, using the
modified prospective method, and, accordingly, we did not restate the consolidated statements of
operations for periods prior to January 1, 2006. This pronouncement amended SFAS No. 123,
Accounting for Stock-Based Compensation, and superseded Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees.
Under SFAS No. 123(R), we measure compensation cost for all stock-based awards at fair value
on the date of grant and recognize compensation expense in our consolidated statements of
operations over the service period that the awards are expected to vest. As permitted under SFAS
No. 123(R), we have elected to recognize compensation cost for all options with graded vesting on a
straight-line basis over the vesting period of the entire option.
In estimating the fair value of stock-based compensation, we use the quoted market price of
our common stock for stock awards, and the Black-Scholes Option Pricing Model for stock options and
warrants. We estimate future volatility based on past volatility of our common stock, and we
estimate the expected length of options based on several criteria, including the vesting period of
the grant and the expected volatility.
New Accounting Pronouncements
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in Income
Taxes, an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the accounting for
uncertainty in income taxes by prescribing the recognition threshold a tax position is required to
meet before being recognized in the financial statements. It also provides guidance on
derecognition, classification, interest and penalties, accounting in interim periods, disclosure,
and transition. FIN 48 is effective for fiscal years beginning after December 15, 2006 and is
required to be adopted in 2007. We do not expect the adoption of FIN 48 to have a material impact
on our financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). SFAS 157
provides guidance for using fair value to measure assets and liabilities. It also responds to
investors requests for expanded information about the extent to which companies measure assets and
liabilities at fair value, the information used to measure fair value, and the effect of fair value
measurements on earnings. SFAS 157 applies whenever other standards required (or permit) assets or
liabilities to be measured at fair value, and does not expand the use of fair value in any new
circumstances. SFAS 157 is effective for financial statements issued for fiscal years beginning
after November 15, 2007. We are currently evaluating the effect that the adoption of SFAS 157 will
have on our consolidated results of operations and financial condition and are not yet in a
position to determine such effects.
In September 2006, the Securities and Exchange Commission issued Staff Accounting Bulletin No.
108 (SAB 108), Considering the Effects of Prior Year Misstatements when Quantifying Misstatements
in Current Year Financial Statements. SAB 108 provides guidance on the consideration of the effects
of prior year misstatements in quantifying current year misstatements for the purpose of a
materiality assessment. SAB 108 establishes an approach that requires quantification of financial
statement errors based on the effects on the Companys balance sheet and statement of operations
and the related financial statement disclosures. SAB 108 is effective for 2007. We do not expect
the adoption of SAB 108 to have a material impact on our financial statements.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to certain market risks associated with interest rate fluctuations and credit
risk on our cash equivalents and marketable securities, which investments are entered into for
purposes other than trading. The primary objective of our investment activities is to preserve
principal, while at the same time maximizing yields without significantly increasing risk. We do
not utilize hedging contracts or similar instruments.
21
SPECTRUM PHARMACEUTICALS, INC.
Our primary exposures relate to (1) interest rate risk on our investment portfolio, and (2)
credit risk of the companies bonds in which we invest. We manage interest rate risk on our
investment portfolio by matching scheduled investment maturities with our cash requirements.
Our investments as of March 31, 2007 are primarily in floating rate securities, short-term
government securities and money market accounts. Because of our ability to redeem these investments
at par with short notice, changes in interest rates would have an immaterial effect on the fair
value of these investments. If a 10% change in interest rates were to have occurred on March 31,
2007, any decline in the fair value of our investments would not be material. In addition, we are
exposed to certain market risks associated with credit ratings of corporations whose corporate
bonds we may purchase from time to time. If these companies were to experience a significant
detrimental
change in their credit ratings, the fair market value of such corporate bonds may
significantly decrease. If these companies were to default on these corporate bonds, we may lose
part or all of our principal. We believe that we effectively manage this market risk by
diversifying our investments, and selecting securities that generally have third party insurance
coverage in the event of default by the issuer.
In addition, we are exposed to foreign currency exchange rate fluctuations relating to
payments we make to vendors, suppliers and license partners using foreign currencies. In
particular, we have foreign expenses associated with our ongoing clinical studies in Europe, where
some of our obligations are incurred in Euros. We mitigate such risk by maintaining a limited
portion of our cash in Euros. Although fluctuations in exchange rates have an effect on our payment
obligations, such fluctuations have not had a material impact on our financial condition or results
of operations as of or for the three-month period ended March 31, 2007.
ITEM 4. Controls and Procedures
We have established disclosure controls and procedures (as such terms are defined in Rules
13(a)-15(e) and 15(d)-15(e)) under the Securities Exchange Act of 1934, as amended, or the Exchange
Act), that are designed to ensure that information required to be disclosed in our Exchange Act
reports is recorded, processed, summarized and reported within the time periods specified in the
SECs rules and forms, and that such information is accumulated and communicated to our management,
including our Chief Executive Officer (our principal executive officer) and Vice President Finance
(our principal financial officer), as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, our management is
required to apply its judgment in evaluating the cost-benefit relationship of possible controls and
procedures. Our disclosure controls and procedures are designed to provide a reasonable level of
assurance of reaching our desired disclosure control objectives.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Principal
Executive Officer and our Principal Financial Officer, of the effectiveness of the design and operation of our disclosure controls and
procedures as of March 31, 2007, the end of the period covered by this report, or the Evaluation
Date. Based on the foregoing, our Principal Executive Officer and
Principal Financial Officer concluded that
our disclosure controls and procedures were effective and were operating at the reasonable
assurance level as of the Evaluation Date.
There has been no change in our internal control over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
22
PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
Arbitration with GPC Biotech
On
December 12, 2006, we filed a Demand for Arbitration with the
American Arbitration Association against GPC Biotech AG (GPC
Biotech) to address our exclusion from participating in sublicense
fee income received by GPC Biotech, and to other non-monetary
violations of our Co-Development and License Agreement, dated
September 30, 2002, for satraplatin (the License Agreement).
In our
March 29, 2007 Consolidated and Amended Demand for Arbitration
and Answer to GPC Biotechs Statement of Counterclaim (the Amended Demand),
we allege that GPC Biotechs material defaults of the License Agreement
include (a) refusing, since December 2005, to pay us our share of
$59.3 million in sublicense fee payments to be received by GPC Biotech
from its European sublicensee, Pharmion GmbH; (b) refusing to negotiate in
good faith over a co-promotion arrangement for the sale and marketing of
satraplatin in the U.S.; (c) failing to acknowledge our license in
GPC Biotechs
publicity materials, investor communications, and other literature; (d) failing
on numerous occasions to provide notice to and to seek our advance input
regarding proposed satraplatin-related public communications; (e) failing to
use commercially reasonable endeavors to obtain regulatory approvals in
Japan; (f) failing to timely provide us with copies of all FDA submissions and correspondence;
and (g) other actions taken in disregard of GPC Biotechs obligations.
As a result, in the Amended Demand, we seek, inter alia, an award (1) declaring
that we may terminate the License Agreement; (2) ordering GPC Biotech to pay us
damages in an amount no less than $11.86 million, plus interest; (3) ordering
GPC Biotech to provide us with a full accounting of all supply purchases and
other transactions giving rise to obligations to make payments to us; and
(4) damages, interest, double or treble damages, and attorneys fees
and costs.
GPC Biotech filed an Answer
to our Amended Demand, denying the allegations therein. Additionally, as part of its
initial Answer to our original Demand, GPC Biotech filed a Statement of Counterclaim.
In its Statement of Counterclaim, GPC Biotech alleges that it did not materially breach
the License Agreement and that our notice of default, attempted termination,
and filing of the Arbitration were made in bad faith and constitute a material
breach of the License Agreement. Accordingly, GPC Biotech seeks, inter alia,
(1) a declaration that it has not defaulted and is not in default of any material
obligation under the License Agreement; (2) a declaration that our alleged
bad-faith misconduct discharges GPC Biotech of any duty to further negotiate
a co-promotion agreement for satraplatin in the United States; (3) a perpetual,
paid-up, royalty-free worldwide license to satraplatin; (4) damages, double or
treble damages, and attorneys fees and costs. In our initial and amended Answer to
GPC Biotechs Statement of Counterclaim, we denied the material allegations of the
Counterclaim and have alleged that the Counterclaim is baseless and should be
denied in its entirety.
A three
member arbitration panel has been selected and has met. We are currently in fact
discovery. The arbitration hearing has been set for July 6 to July 13, 2007, in Boston,
Massachusetts.
No
assurance can be given as to whether we will prevail with respect to this arbitration.
Other
We
are involved in various other legal proceedings arising from the ordinary course of business.
ITEM IA. Risk Factors
RISK FACTORS
An investment in our common stock involves a high degree of risk. Our business, financial
condition, operating results and prospects can be impacted by a number of factors, any one of which
could cause our actual results to differ materially from recent results or from our anticipated
future results. As a result, the trading price of our common stock could decline, and you could
lose a part or all of your investment. You should carefully consider the risks described below with
all of the other information included in this Quarterly Report. For discussion of some of our
potential risks or uncertainties, refer to Part I, Item 1A., Risk Factors, included in our Form
10-K for the fiscal year ended December 31, 2006 as filed with the SEC. The following risk factors
are the only material changes to the risk factors described in the Form 10-K.
Risks
Related to Our Business
An adverse outcome in the arbitration
proceedings with GPC Biotech may hurt our financial and strategic prospects.
We are currently in arbitration with
GPC Biotech as described in Part II, Item 1 Legal Proceedings. The arbitration panel
may rule against us on our demand and/or may rule in favor of GPC Biotech on its
counterclaim, which could cause us significant financial and strategic harm, including if
GPC Biotech does not have to negotiate in good faith with us for a co-promotion
agreement and/or GPC Biotech does not have to pay us milestone payments and
royalties. In addition, GPC Biotech has taken the position that the fact we are
currently in arbitration with them makes negotiation over a co-promotion agreement
no longer tenable, and that further negotiations would neither be appropriate nor productive.
The size of the market for our potential products is uncertain.
We often
provide estimates of the number of people who suffer from the diseases that are
drugs are targeting. However, there is limited information available regarding the
actual size of these patient populations. In addition, it is uncertain whether the
results from previous or future clinical trials of drug candidates will be observed
in broader patient populations, and the number of patients who may benefit from our
drug candidates may be significantly smaller than the estimated patient populations.
23
SPECTRUM PHARMACEUTICALS, INC.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
On
January 30, 2007, a warrant was exercised by an institutional
investor for the purchase
of 45,802 shares of our common stock for cash consideration of $137,406. We believe the sale of the
shares was exempt from registration under the Securities Act of 1933,
as amended (the Securities Act),
pursuant to Section 4(2) of the Securities Act. We made no solicitation in connection with the exercise of the
warrant; we obtained representations from the holder regarding its status as an accredited
investor; and the holder had access to adequate information about us in order to make an informed
investment decision. No underwriting discounts or commissions were paid in conjunction with the
issuance.
On April 16, 2007, we issued 207,957 shares of our common stock upon the conversion of 48
shares of our Series D 8% Cumulative Convertible Voting
Preferred Stock by an institutional investor, at a conversion price of
$2.35 per share. The shares of our common stock were issued without registration under the Act, in
reliance upon the exemption from registration provided under Section 3(a)(9) of the Act. We
received no additional consideration for this conversion.
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Submission of Matters to a Vote of Security Holders
None
ITEM 5. Other Information (not previously reported in a Form 8-K)
None
24
SPECTRUM PHARMACEUTICALS, INC.
ITEM 6. Exhibits
|
|
|
|
|
Exhibit No. |
|
Description |
|
4.1
|
|
|
Amendment No. 2 dated as of March 26, 2007, to Warrant issued by the
Registrant to a consultant, dated as of September 17, 2003. (Filed as
Exhibit 4.1 to Form 10-K/A, as filed with the Securities and Exchange
Commission on April 30, 2007, and incorporated herein by reference.) |
|
|
|
|
|
|
10.1
|
|
|
Second Amendment to the License Agreement by and between Registrant and
Johnson Matthey PLC dated February 23, 2007. (Filed as Exhibit 10.1 to
Form 8-K, as filed with the Securities and Exchange Commission on March
2, 2007, and incorporated herein by reference.) |
|
|
|
|
|
|
31.1+
|
|
|
Certification of Principal Executive Officer, pursuant to Rule 13a-14
promulgated under the Exchange Act, as created by Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
31.2+
|
|
|
Certification of Principal
Financial Officer, pursuant to Rule 13a-14
promulgated under the Exchange Act, as created by Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.1+
|
|
|
Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section
1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.2+
|
|
|
Certification of Principal
Financial Officer, pursuant to 18 U.S.C. Section
1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002. |
25
SPECTRUM PHARMACEUTICALS, INC.
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.
|
|
|
|
|
|
|
SPECTRUM PHARMACEUTICALS, INC. |
|
|
|
|
|
Date: May 2, 2007
|
|
By:
|
|
/s/ Shyam K. Kumaria |
|
|
|
|
|
|
|
|
|
Shyam K. Kumaria, Vice President, Finance
(Authorized Signatory and Principal Financial
Officer)
|
26
EXHIBIT INDEX
|
|
|
|
|
Exhibit No. |
|
Description |
|
4.1
|
|
|
Amendment No. 2 dated as of March 26, 2007, to Warrant issued by the
Registrant to a consultant, dated as of September 17, 2003. (Filed as
Exhibit 4.1 to Form 10-K/A, as filed with the Securities and Exchange
Commission on April 30, 2007, and incorporated herein by reference.) |
|
|
|
|
|
|
10.1
|
|
|
Second Amendment to the License Agreement by and between Registrant and
Johnson Matthey PLC dated February 23, 2007. (Filed as Exhibit 10.1 to
Form 8-K, as filed with the Securities and Exchange Commission on March
2, 2007, and incorporated herein by reference.) |
|
|
|
|
|
|
31.1+
|
|
|
Certification of Principal Executive Officer, pursuant to Rule 13a-14
promulgated under the Exchange Act, as created by Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
31.2+
|
|
|
Certification of Principal
Financial Officer, pursuant to Rule 13a-14
promulgated under the Exchange Act, as created by Section 302 of the
Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.1+
|
|
|
Certification of Principal Executive Officer, pursuant to 18 U.S.C. Section
1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002. |
|
|
|
|
|
|
32.2+
|
|
|
Certification of Principal
Financial Officer, pursuant to 18 U.S.C. Section
1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002. |