Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 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, 2008
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, 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 þ |
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Non-accelerated filer o (Do not check if a smaller reporting company) |
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Smaller reporting company 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 November 5, 2008 |
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Common Stock, $.001 par value
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31,806,876 |
SPECTRUM PHARMACEUTICALS, INC.
TABLE OF CONTENTS
SPECTRUM PHARMACEUTICALS, INC.
FORM 10-Q
For the Three-month and nine-month periods ended September 30, 2008
(Unaudited)
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
Statement Regarding Financial Information
The unaudited condensed consolidated financial statements of Spectrum Pharmaceuticals, Inc.
included herein have been prepared by management pursuant to the rules and regulations of the
Securities and Exchange Commission (SEC). Certain information normally included in the consolidated
financial statements prepared in accordance with accounting principles generally accepted in the
United States has been condensed or omitted pursuant to such rules and regulations. However, we
believe that the disclosures are adequate to make the information presented not misleading.
We recommend that you read the unaudited condensed consolidated financial statements included
herein in conjunction with the audited consolidated financial statements and notes thereto included
in our Annual Report on Form 10-K for the fiscal year ended December 31, 2007, filed with the SEC
on March 14, 2008.
3
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
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September 30, |
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December 31, |
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2008 |
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2007 |
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(In Thousands, Except Share and Per Share Data) |
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Assets |
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Current Assets: |
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Cash and cash equivalents |
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$ |
4,679 |
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$ |
1,141 |
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Marketable securities |
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46,957 |
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54,518 |
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Accounts receivable, net of allowance for doubtful accounts |
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186 |
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191 |
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Inventory |
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1,446 |
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Prepaid expenses and other current assets |
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254 |
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762 |
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Total current assets |
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53,522 |
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56,612 |
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Property and equipment, net |
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1,633 |
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716 |
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Other assets |
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143 |
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212 |
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Total assets |
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$ |
55,298 |
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$ |
57,540 |
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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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$ |
3,217 |
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$ |
1,598 |
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Accrued compensation |
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1,145 |
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1,111 |
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Accrued drug development costs |
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3,572 |
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5,090 |
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Total current liabilities |
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7,934 |
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7,799 |
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Deferred revenue and other credits |
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1,026 |
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992 |
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Total liabilities |
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8,960 |
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8,791 |
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Commitments
and Contingencies (Note 3) |
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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 E Convertible Voting Preferred Stock, 2,000 shares authorized,
stated value $10,000 per share, $2.0 million aggregate liquidation
value, issued and outstanding, 68 and 170 shares at September 30, 2008
and December 31, 2007, respectively |
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419 |
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1,048 |
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Common stock, par value $0.001 per share, 100,000,000 shares authorized: |
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Issued and outstanding, 31,771,876 and 31,233,798 shares at
September 30, 2008 and December 31, 2007, respectively |
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32 |
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31 |
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Additional paid-in capital |
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294,051 |
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288,927 |
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Accumulated other comprehensive income |
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390 |
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493 |
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Accumulated deficit |
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(248,554 |
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(241,750 |
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Total stockholders equity |
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46,338 |
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48,749 |
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Total liabilities and stockholders equity |
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$ |
55,298 |
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$ |
57,540 |
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The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
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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Nine Months |
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Nine Months |
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Ended |
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Ended |
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Ended |
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Ended |
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September 30, 2008 |
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September 30, 2007 |
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September 30, 2008 |
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September 30, 2007 |
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(In Thousands, Except Share and Per Share Data) |
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Revenues |
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Licensing and milestone revenues |
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$ |
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$ |
3,250 |
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$ |
20,676 |
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$ |
7,625 |
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Total Revenues |
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$ |
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$ |
3,250 |
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$ |
20,676 |
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$ |
7,625 |
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Operating expenses: |
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Research and development |
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$ |
5,960 |
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$ |
8,532 |
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$ |
19,089 |
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$ |
22,025 |
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Selling, general and administrative |
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3,132 |
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3,027 |
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8,947 |
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9,411 |
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Total operating expenses |
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9,092 |
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11,559 |
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28,036 |
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31,436 |
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Loss from operations |
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(9,092 |
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(8,309 |
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(7,360 |
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(23,811 |
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Other income, net |
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276 |
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927 |
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556 |
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2,259 |
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Net loss |
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$ |
(8,816 |
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$ |
(7,382 |
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$ |
(6,804 |
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$ |
(21,532 |
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Basic and diluted net loss per share |
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$ |
(0.28 |
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$ |
(0.24 |
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(0.22 |
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$ |
(0.76 |
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Basic and diluted weighted average common
shares outstanding |
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31,538,023 |
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31,034,241 |
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31,424,358 |
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28,276,992 |
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The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
5
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Nine Months |
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Nine Months |
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Ended |
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Ended |
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September 30, 2008 |
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September 30, 2007 |
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(In Thousands, Except Share and Per Share Data) |
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Cash Flows From Operating Activities: |
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Net loss |
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$ |
(6,804 |
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$ |
(21,532 |
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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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146 |
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187 |
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Share-based compensation |
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4,207 |
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4,096 |
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Fair value of common stock issued in connection with drug license |
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305 |
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520 |
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Minority interest in subsidiary |
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(20 |
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Changes in operating assets and liabilities: |
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Decrease
<increase> in accounts receivable |
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5 |
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(194 |
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Increase in inventory |
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(1,446 |
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Decrease
<increase> in prepaids and other assets |
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686 |
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(54 |
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Increase in accounts payable and accrued expenses |
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101 |
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1,673 |
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Increase <decrease> in accrued compensation and related taxes |
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34 |
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(78 |
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Increase <decrease> in deferred revenue and other credits |
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17 |
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(30 |
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Net cash used in operating activities |
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(2,749 |
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(15,432 |
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Cash Flows From Investing Activities: |
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Sales <Purchases> of marketable securities |
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7,351 |
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(12,425 |
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Purchases of property and equipment |
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(1,064 |
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(334 |
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Net cash provided by <used in> investing activities |
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6,287 |
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(12,759 |
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Cash Flows From Financing Activities: |
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Proceeds from issuance of common stock and warrants, net of
related offering costs and expenses |
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30,041 |
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Proceeds from exercise of warrants |
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519 |
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Proceeds from exercise of stock options |
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120 |
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Net cash provided by financing activities |
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30,680 |
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Net increase in cash and cash equivalents |
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3,538 |
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2,489 |
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Cash and cash equivalents, beginning of period |
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1,141 |
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519 |
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Cash and cash equivalents, end of period |
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$ |
4,679 |
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$ |
3,008 |
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Supplemental Cash Flow Information: |
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Interest paid |
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$ |
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$ |
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Income taxes paid |
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$ |
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$ |
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Schedule of Non-Cash Investing and Financing Activities: |
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Fair value of common stock issued in connection with drug license |
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$ |
305 |
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$ |
520 |
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Fair value of restricted stock granted employees and directors |
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$ |
275 |
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$ |
1,308 |
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Fair value of stock issued to match employee 401k contributions |
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$ |
208 |
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$ |
129 |
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Fair value of warrants issued to consultants and placement agents |
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$ |
69 |
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$ |
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The accompanying Notes to Condensed Consolidated Financial Statements are an integral part of these statements.
6
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2008
(Unaudited)
1. Business and Basis of Presentation
Business
Spectrum Pharmaceuticals, Inc. (the Company, we, our, or us) is a biopharmaceutical
company with a focus on oncology, urology and other critical health challenges for which there are
few other treatment options.
The following is a brief update of the most advanced products under development as of
September 30, 2008:
Fusilev (levoleucovorin) for injection (FUSILEV): On August 15, 2008, we
commercially launched our proprietary oncology drug FUSILEV, which New Drug Application (NDA) was
approved by the U.S. Food and Drug Administration (FDA) in March 2008. Shipments of FUSILEV for
the period ended September 30, 2008 were approximately $140,000. Based on our revenue recognition
policy, we have deferred the recognition of this revenue and related cost of goods sold until such
time as we have a basis to reliably determine the amount of potential returns and other credits
likely to offset the gross revenues.
FUSILEV rescue is indicated after high-dose methotrexate therapy in patients with
osteosarcoma, the most common form of bone cancer, and is also indicated to diminish the toxicity
and counteract the effects of impaired methotrexate elimination or inadvertent overdose of folic
acid antagonists. Based on the current approved indication for osteosarcoma and the size of the
market, we anticipate the uptake of FUSILEV will continue to remain slow until such time we get an
approval for the use of FUSILEV in colorectal cancer, which is a significantly larger market. We
filed a supplemental NDA for its use in colorectal cancer in 5-fluorouracil containing regimens
with the FDA at the end of October 2008. Also, in June 2008, we filed an NDA amendment for a tablet
formulation.
Apaziquone (EOquin® in bladder cancer): Pursuant to a special protocol assessment
procedure, in 2007, we initiated two Phase 3 clinical studies in the United States and Canada for
Apaziquone in non-muscle invasive bladder cancer. We have received scientific advice from the
European Medicines Agency (EMEA), the European equivalent to the FDA, whereby the EMEA agreed
that the two Phase 3 studies being conducted at this time should be sufficient for a regulatory
decision regarding European registration. We continue to enroll patients into the two trials at
sites in the United States and Canada and expect enrollment in both trials to be completed by the
end of 2009. As described in note 5, on October 28, 2008, we entered into a strategic collaboration
with Allergan, Inc. for the future development and commercialization of Apaziquone in bladder cancer.
Ozarelix (in benign prostatic hypertrophy): In April 2008, we announced the completion
of a 9-month, randomized, double-blind, placebo-controlled, Phase 2b study of the safety and
efficacy of ozarelix, the Companys drug candidate for the treatment of benign prostatic
hypertrophy (BPH). Based on the results of that study, we have designed and submitted to the FDA
the protocol for the next study of ozarelix in BPH and are currently in the process of patient
enrollment.
Sumatriptan and other generic injectibles (non-dilutive funding): During the
nine-month period ended September 30, 2008 , we entered into an agreement with Par Pharmaceutical,
Inc. (Par), our marketing partner for sumatriptan injection, pursuant to which we received a
non-refundable $20 million cash payment from Par for the sale of our share of the profits from the
commercialization of sumatriptan injection. Also, during the nine-month period ended September 30,
2008, we entered into an agreement with Sagent Pharmaceuticals, Inc. (Sagent) to sell to Sagent
rights to certain of our abbreviated new drug applications (ANDAs) for $660,000. These payments
were recorded as revenues when received, since we had no remaining future obligations related
to such transfer of rights.
For a more detailed description of these and our other drugs in development, refer to our
Annual Report on Form 10-K for the year ended December 31, 2007.
7
SPECTRUM PHARMACEUTICALS, INC.
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 and nine-
month periods ended September 30, 2008 are not necessarily indicative of the results that may
be expected for the year ending December 31, 2008. The balance sheet at December 31, 2007 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, 2007.
2. Summary of Significant Accounting Policies and Estimates
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and of its
wholly-owned and majority-owned subsidiaries. As of September 30, 2008, we had one subsidiary:
Spectrum Pharmaceuticals GmbH, a wholly-owned inactive subsidiary incorporated in Switzerland in
April 1997. In June 2008, we dissolved NeoJB, LLC, an 80% owned inactive subsidiary that
was organized in Delaware in April 2002. We have eliminated all significant intercompany accounts
and transactions.
Reclassification of Accounts
Certain reclassifications have been made to prior-year comparative financial statements to
conform to the current year presentation. These reclassifications had no effect on previously
reported results of operations or financial position.
Use of Estimates
The preparation of financial statements in conformity with GAAP 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 share-based compensation. 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.
Fair Value of Financial Instruments
Effective January 1, 2008, we adopted Statement of Financial Accounting Standards No. 157,
Fair Value Measurements, or FAS 157. In February 2008, the Financial Accounting Standards Board
(FASB) issued FASB Staff Position No. FAS 157-2, Effective Date of FASB Statement No. 157,
which provides a one year deferral of the effective date of FAS 157 for non-financial assets and
non-financial liabilities, except those that are recognized or disclosed in the financial
statements at fair value at least annually. Therefore, we adopted the provisions of FAS 157 with
respect to our financial assets and liabilities only. FAS 157 defines fair value, establishes a
framework for measuring fair value under GAAP and enhances disclosures about fair value
measurements. Fair value is defined under FAS 157 as the exchange price that would be received for
an asset or paid to transfer a liability (an exit price) in the principal or most advantageous
market for the asset or liability in an orderly transaction between market participants on the
measurement date. Valuation techniques used to measure fair value under FAS 157 must maximize the
use of observable inputs and minimize the use of unobservable inputs.
We utilize the market approach to measure fair value for our financial assets and liabilities.
The market approach uses prices and other relevant information generated by market transactions
involving identical or comparable assets or liabilities. The standard describes a fair value
hierarchy based on three levels of inputs, of which the first two are considered observable and the
last unobservable, that may be used to measure fair value which are the following:
|
Level 1: |
|
Quoted prices (unadjusted) in active markets that are accessible at the measurement
date for assets or liabilities. The fair value hierarchy gives the highest priority to
Level 1 inputs. |
|
|
Level 2: |
|
Observable prices that are based on inputs not quoted on active markets, but
corroborated by market data. |
|
|
Level 3: |
|
Unobservable inputs are used when little or no market data is available. The fair
value hierarchy gives the lowest priority to Level 3 inputs. |
8
SPECTRUM PHARMACEUTICALS, INC.
In determining fair value, we utilize valuation techniques that maximize the use of observable
inputs and minimize the use of unobservable inputs to the extent
possible, as well as considers
counterparty credit risk in its assessment of fair value.
The adoption of this statement did not have a material impact on our consolidated results of
operations and financial condition. The carrying values of our cash, cash equivalents and
marketable securities, carried at fair value as of September 30, 2008, are classified in the table
below in one of the three categories described above:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fair Value Measurements at September 30, 2008 |
|
|
|
Level 1 |
|
|
Level 2 |
|
|
Level 3 |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash & Equivalents |
|
$ |
4,679 |
|
|
|
0 |
|
|
$ |
0 |
|
|
$ |
4,679 |
|
U.S. Treasury T-Bills |
|
|
23,814 |
|
|
|
0 |
|
|
|
0 |
|
|
|
23,814 |
|
Money Market Currency Funds |
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
|
|
0 |
|
Medium Term Corporate Notes |
|
|
0 |
|
|
$ |
2,000 |
|
|
|
0 |
|
|
|
2,000 |
|
U.S. Treasury Backed Securities |
|
|
0 |
|
|
|
21,142 |
|
|
|
0 |
|
|
|
21,142 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
28,493 |
|
|
$ |
23,142 |
|
|
$ |
0 |
|
|
$ |
51,635 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 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 FASB Statement
(SFAS) No. 115, Accounting for Certain Investments in Debt and Equity Securities. Investments that
lack immediate liquidity, or which we intend to hold for more than one year are classified as
long-term investments, and included in other assets. As of September 30, 2008, substantially all of
our marketable securities were held in short-term US treasury bills or US treasury backed mutual
funds.
Concentrations of Credit Risk
All of our cash, cash equivalents and marketable securities are invested at major financial
institutions. These institutions are required to invest our cash in accordance with our investment
policy with the principal objectives being preservation of capital, fulfillment of liquidity needs
and above market returns commensurate with preservation of capital. Our investment policy also
requires that investments in marketable securities be in only highly rated instruments, which are
primarily US treasury bills or US treasury backed securities, with limitations on investing in
securities of any single issuer. To a limited degree these investments are insured by the Federal
Deposit Insurance Corporation 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 continued credit worthiness of the underlying issuer and
general credit market risks as have existed since late 2007. We manage such risks on our portfolio
by matching scheduled investment maturities with our cash requirements and investing in highly
rated instruments. As of September 30, 2008, substantially all of our marketable securities were
held in short-term US treasury bills or US treasury backed mutual funds.
We believe the financial institutions through which we have invested our funds are strong,
well capitalized and our instruments are held in accounts segregated from the assets of the
institutions. However, due to the current extremely volatile financial and credit markets and
liquidity crunch faced by most banking institutions, the financial viability of these institutions,
and the safety and liquidity of our funds is being constantly monitored.
9
SPECTRUM PHARMACEUTICALS, INC.
Inventory
Inventory is stated at the lower of cost (first-in, first-out method) or market. As of
September 30, 2008, inventory
consisted of finished product of FUSILEV. The lower of cost or market is determined based on
net estimated realizable value after appropriate consideration is given to obsolescence, excessive
levels, deterioration, and other factors.
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.
Upfront monies representing non-refundable fees 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 upfront 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. If revenue from
sales is not reasonably determinable due to provisions for estimates, promotional adjustments,
price adjustments, returns or any other potential adjustments, we defer the revenue and recognize
revenue when the estimates are reasonably determinable, even if the monies for the gross sales have
been received.
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 drug development 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 recorded in the period in which the facts that give rise to the revision become known.
Basic and Diluted Net Income (Loss) per Share
In accordance with FASB Statement No. 128, Earnings Per Share, we calculate basic net income
(loss) per share by using the weighted average number of common shares outstanding during the
periods presented. Diluted net income (loss) per share is calculated by using the weighted average
number of common shares outstanding during the periods presented, increased to include all
additional dilutive common shares issuable pursuant to outstanding common stock equivalents,
determined using the treasury-stock method.
10
SPECTRUM PHARMACEUTICALS, INC.
Potentially dilutive common stock equivalents include the common stock issuable upon the
conversion of preferred stock and the exercise of warrants and stock options. These are included in
the calculation of diluted net income (loss) per share only when their effect is dilutive. 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.
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.
The following table presents the data used in the calculations of basic and diluted net loss
per share for the three-month and nine-month periods ended September 30, 2008 and 2007.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Months |
|
|
Three-Months |
|
|
Nine-Months |
|
|
Nine-Months |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
September 30, 2008 |
|
|
September 30, 2007 |
|
|
September 30, 2008 |
|
|
September 30, 2007 |
|
|
|
(In Thousands, Except Share and Per Share Data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
(8,816 |
) |
|
$ |
(7,382 |
) |
|
$ |
(6,804 |
) |
|
$ |
(21,532 |
) |
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred dividends paid in cash or stock |
|
|
0 |
|
|
|
(10 |
) |
|
|
0 |
|
|
|
(12 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) attributable to common
stockholders |
|
$ |
(8,816 |
) |
|
$ |
(7,392 |
) |
|
$ |
(6,804 |
) |
|
$ |
(21,544 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
31,538,023 |
|
|
|
31,034,241 |
|
|
|
31,424,358 |
|
|
|
28,276,992 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.28 |
) |
|
$ |
(0.24 |
) |
|
$ |
(0.22 |
) |
|
$ |
(0.76 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounting for Share-Based Employee Compensation
Effective January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment. We measure
compensation cost for all share-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 share-based compensation, we use the closing 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.
We recorded share-based compensation expense during the three-month and nine-month periods
ended September 30, 2008 and 2007, as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Months |
|
|
Three-Months |
|
|
Nine-Months |
|
|
Nine-Months |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
September 30, 2008 |
|
|
September 30, 2007 |
|
|
September 30, 2008 |
|
|
September 30, 2007 |
|
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
630 |
|
|
$ |
1,215 |
|
|
$ |
2,630 |
|
|
$ |
2,532 |
|
General and administrative |
|
|
461 |
|
|
|
654 |
|
|
|
1,577 |
|
|
|
1,565 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total share based charges |
|
$ |
1,091 |
|
|
$ |
1,869 |
|
|
$ |
4,207 |
|
|
$ |
4,097 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
11
SPECTRUM PHARMACEUTICALS, INC.
Income Taxes
We recorded no tax provision for the three-month and nine-month periods ended September 30,
2008, based on an anticipated operating loss for the full calendar year.
Deferred tax assets and liabilities are recognized for the future tax consequences
attributable to differences between the financial statement carrying amounts of existing assets and
liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income in the years in which those temporary
differences are expected to be recovered or settled. The effect on the deferred tax assets and
liabilities of a change in tax rates is recognized in income in the period that includes the
enactment date. The Company has determined that the deferred tax asset does not meet the more
likely than not criteria under SFAS No. 109, Accounting for Income Taxes, and, accordingly, a
valuation allowance has been recorded to reduce the net deferred tax asset to zero.
Comprehensive Income
Comprehensive income is calculated in accordance with SFAS No. 130, Reporting Comprehensive
Income. SFAS No. 130 requires the disclosure of all components of comprehensive income, including
net income and changes in equity during a period from transactions and other events and
circumstances generated from non-owner sources. The Companys accumulated other comprehensive
income at September 30, 2008 consisted primarily of net unrealized gains on investments in
marketable securities as of that date.
Recent Accounting Pronouncements
Effective January 2008, we adopted the provisions of EITF Issue No. 07-3, Accounting for
Nonrefundable Advance Payments for Goods or Services to Be Used in Future Research and Development
Activities, or Issue 07-3, which addresses the accounting for nonrefundable advance payments. The
EITF concluded that nonrefundable advance payments for goods or services to be received in the
future for use in research and development activities should be deferred and capitalized. The
capitalized amounts should be expensed as the related goods are delivered or the services are
performed. If an entitys expectations change such that it does not expect it will need the goods
to be delivered or the services to be rendered, capitalized nonrefundable advance payments should
be charged to expense. The adoption of Issue No. 07-3 did not have a material impact on our results
of operations or financial position.
In December 2007, the FASB ratified the final consensuses in Emerging Issues Task Force, or
EITF, Issue No. 07-1, Accounting for Collaborative Arrangements, or Issue 07-1, which requires
certain income statement presentation of transactions with third parties and of payments between
parties to the collaborative arrangement, along with disclosure about the nature and purpose of the
arrangement. Issue 07-1 is effective for us beginning January 1, 2009. We do not expect the
adoption of this accounting pronouncement to have a significant impact on our financial statements.
In December 2007, the FASB issued SFAS No. 141(R), Business Combinations (SFAS No. 141(R)),
which replaces SFAS No. 141, Business
Combinations. SFAS No. 141(R), requires an acquirer to
recognize the assets acquired, the liabilities assumed, and any non-controlling interest in the
acquiree at the acquisition date, measured at their fair values as of that date, with limited
exceptions. This Statement also requires the acquirer in a business combination achieved in stages
to recognize the identifiable assets and liabilities, as well as the non-controlling interest in
the acquiree, at the full amounts of their fair values. SFAS No. 141(R) makes various other
amendments to authoritative literature intended to provide additional guidance or to confirm the
guidance in that literature to that provided in this Statement. This Statement applies
prospectively to business combinations for which the acquisition date is on or after the beginning
of the first annual reporting period beginning on or after December 15, 2008. We do not expect the
adoption of this accounting pronouncement to have a significant impact on our financial statements.
12
SPECTRUM PHARMACEUTICALS, INC.
In December 2007, the FASB issued SFAS No. 160, Noncontrolling Interests in Consolidated
Financial Statements (SFAS No. 160), which amends Accounting Research Bulletin No. 51, Consolidated
Financial Statements, to improve the relevance, comparability, and transparency of the financial
information that a reporting entity provides in its consolidated financial statements. SFAS No. 160
establishes accounting and reporting standards that require the ownership interests in subsidiaries
not held by the parent to be clearly identified, labeled and presented in the consolidated
statement of financial position within equity, but separate from the parents equity. This
statement also requires the amount of consolidated net income attributable to the parent and to the
non-controlling interest to be clearly identified and presented on the face of the consolidated
statement of income. Changes in a parents ownership interest while the parent retains its
controlling financial interest must be accounted
for consistently, and when a subsidiary is deconsolidated, any retained non-controlling equity
investment in the former subsidiary must be initially measured at fair value. The gain or loss on
the deconsolidation of the subsidiary is measured using the fair value of any non-controlling
equity investment. The Statement also requires entities to provide sufficient disclosures that
clearly identify and distinguish between the interests of the parent and the interests of the
non-controlling owners. This Statement applies prospectively to all entities that prepare
consolidated financial statements and applies prospectively for fiscal years, and interim periods
within those fiscal years, beginning on or after December 15, 2008. We do not expect the adoption
of this accounting pronouncement to have a significant impact on our financial statements.
In March 2008, the FASB issued SFAS No. 161, Disclosures about Derivative Instruments and
Hedging Activities, an amendment of FASB Statement No. 133 (SFAS No. 161). SFAS No. 161 amends and
expands the disclosure requirements of SFAS No. 133 with the intent to provide users of financial
statements with an enhanced understanding of: (i) How and why an entity uses derivative
instruments; (ii) How derivative instruments and related hedged items are accounted for under SFAS
No. 133 and its related interpretations and (iii) How derivative instruments and related hedged
items affect an entitys financial position, financial performance and cash flows. This Statement
is effective for financial statements issued for fiscal years and interim periods beginning after
November 15, 2008, with early application encouraged. We do not expect the adoption of this
accounting pronouncement to have a significant impact on our financial statements.
In May 2008, the FASB issued SFAS No. 162 The Hierarchy of Generally Accepted Accounting
Principles (SFAS 162), which is effective 90 days following the SECs approval of the Public
Company Oversight Board amendments to AU Section 411, The Meaning of Present Fairly in Conformity
With Generally Accepted Accounting Principles. SFAS 162 identifies the sources of accounting
principles and the framework for selecting the principles to be used in the preparation of
financial statements of nongovernmental entities that are presented in conformity with generally
accepted accounting principles (GAAP) in the United States (the GAAP hierarchy). We do not expect
the adoption of this accounting pronouncement to have a significant impact on our financial
statements.
In
June 2008, the FASB issued FSP EITF 03-6-1, Determining Whether Instruments Granted in
Share-Based Payment Transactions Are Participating Securities
(FSP EITF 03-6-1). FSP EITF 03-6-1 addresses whether
instruments granted in share-based payment transactions are participating securities prior to
vesting and, therefore, need to be included in computing earnings per share under the two-class
method described in SFAS No. 128, Earnings Per Share. FSP EITF 03-6-1 requires companies to treat
unvested share-based payment awards that have non-forfeitable rights to dividend or dividend
equivalents as a separate class of securities in calculating earnings per share. FSP EITF 03-6-1
will be effective for the Companys fiscal year beginning March 1, 2009, with early adoption
prohibited. We are evaluating the effect the implementation of FSP EITF 03-6-1 will have, if any,
on basic net earnings per share.
13
SPECTRUM PHARMACEUTICALS, INC.
3. Commitments and Contingencies
Facility and Equipment Leases
As of September 30, 2008, we were obligated under a facility lease and several operating
equipment leases. The facility lease will expire on June 30, 2009. While we have a 5-year renewal
option, we are evaluating whether to renew the lease for an additional 5 years or consider securing
an alternate facility. In the event we decide to secure an alternate facility, we do not expect the
relocation to adversely affect our operations.
Minimum lease requirements for each of the next five years and thereafter, under the property
and equipment operating leases, are as follows:
|
|
|
|
|
|
|
Amounts In Thousands |
|
|
|
|
|
|
2008 (Remainder of year) |
|
$ |
132 |
|
2009 |
|
|
289 |
|
2010 |
|
|
153 |
|
2011 |
|
|
0 |
|
2012 |
|
|
0 |
|
Thereafter |
|
|
0 |
|
|
|
|
|
|
|
$ |
573 |
|
|
|
|
|
Licensing Agreements
Almost all of our drug candidates are being developed pursuant to license agreements that
provide us with rights in certain territories to, among other things, develop, sublicense,
manufacture and sell the drugs. 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 license 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.
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 items are 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, if at all. Accordingly, the milestone payments
represent contingent obligations that will be recorded as expense when the milestone is achieved.
While it is difficult to predict when milestones will be achieved, we estimate that if all of our
contingent milestones were successfully achieved within our anticipated timelines, our potential
contingent cash development and regulatory milestone obligations,
aggregating approximately $64.8
million as of September 30, 2008, would be due approximately as follows: $0.3 million within 12
months; $6.6 million in 2 to 3 years; $7.2 million in
4 to 5 years; and $50.7 million after 5
years. In the event these milestones are achieved, 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.
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 contracts are varied and generally obligate us to pay in
stages, depending on the occurrence of certain events specified in the contracts, such as contract
execution, reservation of service or production capacity, actual performance of service, or the
successful accrual and dosing of patients.
At each period end, we accrue for all costs of goods and services received, with such accruals
based on factors such as estimates of work performed, patient enrollment, completion of patient
studies and other events. As of September 30, 2008, we were committed under such contracts for up
to approximately $14.9 million, for future goods and services, including approximately $6.7 million
due within one year. We are in a position to accelerate, slow-down or discontinue any or all of the
projects that we are working on at any given point in time. Should we decide to discontinue and/or
slow-down the work on any project, the associated costs for those projects would get limited to the
extent of the work completed. Generally, we are able to terminate these contracts due to the
discontinuance of the related project(s) and thus avoid paying for the services that have not yet
been rendered and our future purchase obligations would reduce accordingly.
14
SPECTRUM PHARMACEUTICALS, INC.
4. Stockholders Equity
Series E Preferred Stock
In September 2008, we issued 204,000 shares of our common stock upon the conversion of 102
shares of our Series E Convertible Voting Preferred Stock by an institutional investor, at a
conversion price of $5.00 per share.
Common Stock
In March 2008, we issued to Targent, LLC 125,000 shares of the Companys common stock for
payment of a milestone pursuant to the asset purchase agreement with Targent in connection with the
approval of FUSILEV by the FDA. The fair value of the stock, $305,000, was recorded as a
stock-based research and development charge for the nine-month period ended September 30, 2008.
Common Stock Reserved for Future Issuance
As of September 30, 2008, approximately 13.5 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 E preferred shares |
|
|
136,000 |
|
Exercise of stock options |
|
|
7,780,208 |
|
Exercise of warrants |
|
|
5,602,005 |
|
|
|
|
|
|
|
|
|
|
Total shares of common stock reserved for future issuances |
|
|
13,518,213 |
|
|
|
|
|
Share-Based Compensation
As of September 30, 2008, approximately 750,000 incentive award shares were available for
grant under our share-based incentive award plan. Share-based awards generally vest over periods of
up to four years and have a ten-year life.
15
SPECTRUM PHARMACEUTICALS, INC.
Presented below is a summary of activity, for our entire share-based incentive award plans,
during the nine-month period ended September 30, 2008:
Stock Options:
During the nine-month ended September 30, 2008, the Compensation Committee granted stock options
at exercise prices equal to or greater than the quoted price of our common stock as of the grant
dates. The weighted average grant date fair value of stock options granted during the nine-month
period ended September 30, 2008 was estimated at approximately $1.36, using the Black-Scholes
option pricing model with the following assumptions: dividend yield of 0%; expected volatility
(based on the historical volatility of our common stock) of 65.9%; risk free interest rate of 2.8%;
and an expected life of 5 years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
|
|
|
|
|
|
Common |
|
|
Average |
|
|
Weighted |
|
|
Aggregate |
|
|
|
Stock |
|
|
Exercise |
|
|
Average |
|
|
Intrinsic |
|
|
|
Options |
|
|
Price |
|
|
Remaining Term |
|
|
Value |
|
|
|
|
|
|
|
|
|
(In Years) |
|
|
(In Thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding at beginning of year |
|
|
6,482,260 |
|
|
$ |
5.91 |
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,623,000 |
|
|
$ |
2.38 |
|
|
|
|
|
|
|
|
|
Expired |
|
|
(105,510 |
) |
|
$ |
5.53 |
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(219,542 |
) |
|
$ |
3.94 |
|
|
|
|
|
|
|
|
|
Exercised |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, at the end of period |
|
|
7,780,208 |
|
|
$ |
5.24 |
|
|
|
7.23 |
|
|
$ |
57 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, at
end of period |
|
|
7,565,383 |
|
|
$ |
5.26 |
|
|
|
6.94 |
|
|
$ |
56 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, at the end of period |
|
|
5,631,958 |
|
|
$ |
5.51 |
|
|
|
6.59 |
|
|
$ |
53 |
|
|
|
|
|
The aggregate intrinsic value in the table above represents the total difference between the
Companys closing common stock price of $1.41 on September 30, 2008 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 September 30, 2008. This amount changes
based on the fair market value of the Companys common stock.
During the nine-month period ended September 30, 2008, the share-based charge in connection
with the expensing of stock options was approximately $3.3 million. As of September 30, 2008, there
was approximately $5.4 million of unrecognized stock-based compensation cost related to stock
options which is expected to be recognized over a weighted average period of 1.5 years.
Restricted Stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Restricted |
|
|
Average |
|
|
|
Stock |
|
|
Grant Date |
|
|
|
Awards |
|
|
Fair Value |
|
Nonvested at beginning of period |
|
|
277,500 |
|
|
$ |
5.03 |
|
Granted |
|
|
97,500 |
|
|
|
2.46 |
|
Vested |
|
|
(199,750 |
) |
|
|
3.79 |
|
Forfeited |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at the end of period |
|
|
175,250 |
|
|
$ |
5.01 |
|
|
|
|
|
|
|
|
The fair value of restricted stock awards is the grant date closing 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 nine-month period ended September 30, 2008, the share-based charge in connection
with the expensing of restricted stock awards was approximately $0.6 million. As of September 30,
2008, there was approximately $0.5 million of unrecognized share-based compensation cost related to
nonvested restricted stock awards, which is expected to be recognized over a weighted average
period of 1.2 years.
16
SPECTRUM PHARMACEUTICALS, INC.
401(k) Plan Matching Contribution:
During the nine-month period ended September 30, 2008, we issued 128,816 shares of common
stock as the Companys match of approximately $208,000 on the 401(k) contributions of our
employees.
Warrants Activity
We have issued warrants to purchase shares of our common stock to investors as part of
financing transactions, 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 nine-month period ended September 30, 2008:
|
|
|
|
|
|
|
|
|
|
|
Common Stock |
|
|
Weighted Average |
|
|
|
Warrants |
|
|
Exercise Price |
|
Outstanding at beginning of period |
|
|
9,652,051 |
|
|
$ |
6.51 |
|
Granted |
|
|
50,000 |
|
|
|
1.79 |
|
Expired |
|
|
(4,100,046 |
) |
|
|
5.43 |
|
|
|
|
|
|
|
|
Outstanding, at the end of period |
|
|
5,602,005 |
|
|
$ |
7.26 |
|
|
|
|
|
|
|
|
Exercisable, at the end of period |
|
|
5,580,130 |
|
|
$ |
7.28 |
|
|
|
|
|
|
|
|
5. Subsequent Events
On October 28, 2008, we entered into a License, Development, Supply and Distribution Agreement
(the License Agreement) with Allergan Sales, LLC, Allergan USA, LLC and Allergan, Inc.
(collectively, Allergan), pursuant to which both parties have agreed to a collaboration for the
development and commercialization of a formulation of Apaziquone (EOquin®) suitable for use in
treating cancer or precancerous conditions via instillation.
The License Agreement provides that Allergan has the exclusive right to make, develop and
commercialize Apaziquone for the treatment of bladder cancer, or pre-bladder cancer conditions
worldwide except for Asia. Also on October 28, 2008, both parties also entered into a Co-Promotion
Agreement (the Co-Promotion Agreement) providing for the joint commercialization of Apaziquone in
the United States whereby both parties will share equally all profits and commercialization
expenses.
In consideration for the rights granted under the License Agreement, Allergan has paid us an
upfront fee of $41.5 million in accordance with the License Agreement. In addition, Allergan will
pay us up to $304 million based on the achievement of certain development, regulatory and sales
milestones and also tiered royalties starting in the mid-teens based on a percentage of net sales
of Apaziquone outside of the United States.
Further, we will continue to conduct the current Phase 3 clinical trials as well as certain
future planned clinical trials pursuant to a joint development plan, with Allergan bearing
sixty-five percent (65%) of the development costs and us responsible for thirty-five percent (35%)
of the development costs of Apaziquone.
We also have the right, in our sole discretion, to opt out of the co-promotion agreement
before January 1, 2012. If we do so, our share of any future development costs shall be
significantly reduced. Part of the aggregate development costs and marketing expenses incurred by
us since January 1, 2009 shall be reimbursed by Allergan in the form of a one-time payment. The
co-promotion agreement will terminate and instead of a sharing of profit and expenses, Allergan
will pay us royalties on a percentage of net sales of Apaziquone in the United States that are
slightly greater than the royalties paid on net sales outside the United States. In addition,
Allergan will pay us up to $245 million in additional milestones based upon the achievement of
certain sales milestones in the United States.
17
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, without limitation,
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 regulatory success of our products, the timing and likelihood of achieving regulatory
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 in our periodic reports filed with the Securities and Exchange Commission including our
Annual Report on Form 10-K for the fiscal year ended December 31, 2007 and our Quarterly Reports on
Form 10-Q for the periods ended March 31, 2008 and June 30, 2008. 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; |
|
|
|
efforts of our development partners; |
|
|
|
the ability of our manufacturing partners to meet our timelines; |
|
|
|
our ability to identify new product candidates; |
|
|
|
the timing and/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 fast changing economic and financial 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 I of Part 1 of this report.
18
SPECTRUM PHARMACEUTICALS, INC.
Business Outlook
We are a biopharmaceutical company with a focus primarily on oncology and urology. Our primary
business focus for the remainder of 2008, and beyond, will be to continue to acquire, develop and
commercialize a portfolio of 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:
|
|
|
Fusilev (levoleucovorin) for injection (FUSILEV): On August 15, 2008, we
commercially launched our proprietary oncology drug FUSILEV, which
New Drug Application (NDA)
was approved by the U.S. Food and Drug Administration (FDA) in March 2008. Shipments of
FUSILEV for the period ended September 30, 2008 were approximately $140,000. Based on our
revenue recognition policy, we have deferred the recognition of this revenue and related
cost of goods sold until such time as we have a basis to reliably determine the amount of
potential returns and other credits likely to offset the gross revenues. |
FUSILEV rescue is indicated after high-dose methotrexate therapy in patients with
osteosarcoma, the most common form of bone cancer, and is also indicated to diminish the
toxicity and counteract the effects of impaired methotrexate elimination or inadvertent
overdose of folic acid antagonists. Based on the current approved indication for osteosarcoma
and the size of the market, we anticipate the uptake of FUSILEV will continue to remain slow
until such time we get an approval for the use of FUSILEV in colorectal cancer, which is a
significantly larger market. We filed a supplemental NDA for its use in colorectal cancer in
5-fluorouracil containing regimens with the FDA at the end of October 2008. Also, in June
2008, we filed an NDA amendment for a tablet formulation.
|
|
|
Apaziquone (EOQuin® in
bladder cancer): Pursuant to a special protocol
assessment procedure, in 2007, we initiated two Phase 3 clinical studies in the United
States and Canada for Apaziquone in non-muscle invasive bladder cancer. We have received
scientific advice from the European Medicines Agency
(EMEA), the European equivalent to
the FDA, whereby the EMEA agreed that the two Phase 3 studies being conducted at this time
should be sufficient for a regulatory decision regarding European registration. We continue
to enroll patients into the two trials at sites in the United States and Canada and expect
enrollment in both trials to be completed by the end of 2009. As
described in note 5 of our unaudited financial statements included in
this Quarterly Report, on October 28, 2008, we entered into a
strategic collaboration with Allergan, Inc. for the
future development and commercialization of Apaziquone in bladder cancer. |
|
|
|
Ozarelix (in benign prostatic hypertrophy): In April 2008, we announced the
completion of a 9-month, randomized, double-blind, placebo-controlled, Phase 2b study of
the safety and efficacy of ozarelix, the Companys drug candidate for the treatment of
benign prostatic hypertrophy (BPH). Based on the results of that study, we have designed
and submitted to the FDA the protocol for the next study of ozarelix in BPH and are
currently in the process of patient enrollment. |
|
|
|
SPI-1620 (adjunct to chemotherapy): We are continuing to enroll patients in a
Phase 1, open label, dose-escalation study assessing the safety, tolerability,
pharmacokinetics and pharmacodynamics of SPI-1620 in patients with recurrent or progressive
carcinoma. |
|
|
|
We plan to continue to fund the development of our other products. |
|
|
|
We expect to continue to evaluate additional promising drug product candidates, as well
as marketed products, for opportunistic acquisition or license. |
19
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 September 30, 2008, are approximately $250 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 the out-license or product sales of any of our drugs.
We believe that the approximately $52 million in cash, cash equivalents and marketable
securities that we had on hand as of September 30, 2008, together with the $41.5 million we
received from Allergan on November 5, 2008 will allow
us to fund our current planned operations for at least the next eighteen to twenty-four months. We
also believe the financial institutions through which we have invested our funds are strong, well
capitalized and our instruments are held in accounts segregated from the assets of the
institutions. However, due to the current extremely volatile financial and credit markets and
liquidity crunch faced by most banking institutions, the financial viability of these institutions,
and the safety and liquidity of our funds is being constantly monitored.
Our long-term strategy, however, is to generate profits from the sale and licensing of our
drug products. Accordingly, in the next several years, we expect to supplement our cash position
with sales of FUSILEV and licensing revenues from out-licensing our other drug products.
Nevertheless, while we do not currently plan to obtain additional capital through the sale of
debt or equity securities, we may do so if necessary, especially in conjunction with opportunistic acquisitions or license of drugs.
In this regard, in April 2008, we filed a
shelf registration statement with the SEC to give us the ability, from time to time, to offer any
combination of our securities described in the registration statement in one or more offerings for
up to $150 million. There can be no assurance that we will be able to obtain such additional
capital when needed, or, if available, that it will be on terms favorable to us or to our
stockholders. If additional funds are raised by issuing equity securities, the percentage ownership
of our stockholders will be reduced, stockholders may experience additional dilution or such equity
securities may provide for rights, preferences or privileges senior to those of the holders of our
common stock.
As described elsewhere in this report, as well as the risk factors in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2007 and our Quarterly Report on Form 10-Q for the
period ended March 31, 2008, 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, completion dates, and ultimate aggregate cost of developing each of our drug
product candidates. In addition, while we expect revenues in 2008 from sales of FUSILEV, we are
unable to reasonably estimate when, if ever, we will realize material net profit from sales of
FUSILEV or of our other drug products, if they are approved by the FDA. 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,
including, but not limited to, upfront license fees, milestone payments, active pharmaceutical
ingredients, clinical trials, and patent related costs, and non-product specific, or indirect,
costs. During the nine-month period ended September 30, 2008, our total research and development
expenditure, excluding stock-based charges of $3.0 million, was approximately $16.1 million, of
which approximately $8.1 million was in direct costs. The principal components of such direct
expenses for that period were direct costs related to the development of Apaziquone approximately $3.6 million; ozarelix approximately $2.1 million; and
FUSILEV oral and liquid finished product development, including for the colorectal cancer
supplemental NDA filing approximately $1.2 million.
While we are currently focused on advancing our key product development programs, we
anticipate that we will make regular determinations as to which other 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.
20
SPECTRUM PHARMACEUTICALS, INC.
Our anticipated net use of cash for operations in the last quarter of 2008, excluding the cost
of in-licensing additional drugs, if any, is expected to range between approximately $7 million and
$9 million. Our primary focuses for the rest of 2008 and for 2009, and the programs that are
expected to represent a significant part of our expenditures, are the on-going clinical studies of
Apaziquone and the commercial launch of FUSILEV. Key factors that we will monitor as we
determine the funding of other development projects are:
|
|
|
the success of the commercial launch of FUSILEV; |
|
|
|
continued patient enrollment in our Apaziquone clinical trials at anticipated
rates; and |
|
|
|
continued positive results from our preclinical studies and clinical trials. |
Further, while we do not receive any funding from third parties for research and development
that we conduct, co-development and out-licensing agreements with other companies for any of our
drug products may reduce our expenses. In this regard, we entered into a collaboration agreement
with Allergan whereby, commencing January 1, 2009, Allergan will bear 65% of the future
development costs of Apaziquone.
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/or common stock and our research and
development expenditures would likely increase.
Net Cash used in Operating Activities
During the nine-month period ended September 30, 2008, net cash used in operations was
approximately $2.8 million compared to net cash used in operations of approximately $15.4 million
in the comparative period of 2007. The decrease of approximately $12.6 million is primarily due to an
increase in revenues of approximately $13.0 million during the nine-month period ended September
30, 2008 compared to 2007, partially offset by an increase in inventory of approximately $1.5
million at September 30, 2008.
Net Cash provided by Investing Activities
Net cash provided by investing activities of approximately $6.3 million was primarily
due to the conversion of our marketable securities into cash, mainly for our operations and capital
expenditures related to our research and development activities.
Results of Operations
Results of Operations for the three-month period ended September 30, 2008 compared to the
three-month period ended September 30, 2007
For
the three-month period ended September 30, 2008, we recorded a net loss of approximately
$8.8 million, compared to a net loss of approximately $7.4 million for the three-month period ended
September 30, 2007. The principal components of the year-to-year changes in line items are
discussed below.
During the three-month period ended September 30, 2007, we recognized approximately $3.3
million in licensing milestone and related revenues, pursuant to our
agreement with GPC Biotech (GPC).
The milestones were related to the filing and acceptance of a Marketing Authorization Application
by Pharmion with the EMEA. We did not earn similar revenues from GPC during the three-month period
ended September 30, 2008, and we do not anticipate any similar significant revenues from GPC at
this time.
We
commercially launched our proprietary oncology drug FUSILEV, which was approved by the FDA
in March 2008. Shipments of FUSILEV for the period ended September 30, 2008 were approximately
$140,000. Based on our revenue recognition policy, we have deferred the recognition of this revenue
and related cost of goods sold until such time that we have a basis to reliably determine the
amount of potential returns and other credits likely to offset the gross revenues. Based on the
current approved indication for osteosarcoma and the size of the market, we anticipate the uptake
of FUSILEV will continue to remain slow till such time we obtain approval for the use of FUSILEV in
colorectal cancer, which is a significantly larger market.
Research and development expenses decreased by approximately $2.5 million, from approximately
$8.5 million in the three-month period ended September 30, 2007 to approximately $6.0 million in
the three-month period ended September 30, 2008, primarily due to the following: during the
comparative period in 2007, we made a milestone
payment of approximately $0.5 million upon the acceptance of the NDA for satraplatin and because of the timing of the next Ozarelix study. We expect cash research and development
expense in the fourth quarter to continue at a pace similar to the quarter ended September 30,
2008.
21
SPECTRUM PHARMACEUTICALS, INC.
Selling, general and administrative expenses increased by approximately $0.1 million, from
approximately $3.0 million in the three-month period ended September 30, 2007 to approximately $3.1
million in the three-month period ended September 30, 2008, primarily due to increased sales and marketing expenses of approximately $1.4 million incurred in connection with
the commercial launch activities associated with FUSILEV; offset by a reduction in legal
expenses incurred in 2007 in connection with the GPC arbitration. We expect cash selling, general and
administrative expenses in the fourth quarter to continue at a pace similar to the quarter ended
September 30, 2008.
Other income consisted of net interest income of approximately $276,000 and $927,000
for the three-month periods ended September 30, 2008 and September 30, 2007. The decrease in
interest income was primarily due to lower investment yields in 2008 due to the shift in our
investment strategy in light of the current volatile credit markets to investments primarily in US
Treasury bills and US treasury backed securities. We expect similar yields going forward till such
time as the credit markets stabilize.
Results of Operations for the nine-month period ended September 30, 2008 compared to the
nine-month period ended September 30, 2007
For
the nine-month period ended September 30, 2008, we recorded net loss of $6.8 million,
compared to a net loss of approximately $21.5 million for the nine-month period ended September 30,
2007. The principal components of the year-to-year changes in line items are discussed below.
During the nine-month period ended September 30, 2008, we entered into an asset purchase
agreement with Par, our marketing partner for sumatriptan injection, pursuant to which we received
a non-refundable $20 million cash payment from Par for the transfer of our share of the profits
from the commercialization of sumatriptan injection. During this period, we also recorded revenue
from the transfer of rights to certain of our ANDAs to Sagent for $660,000. We did not have similar
income from Par or Sagent during the period ended September 30, 2007. During the nine-month period
ended September 30, 2007, we recognized approximately $7.6 million in licensing milestone and
related revenues, pursuant to our agreement with GPC. The milestones were related to the
filing and acceptance of a Marketing Authorization Application by Pharmion with the EMEA. We did
not earn similar revenues from GPC during the nine-month period ended September 30, 2008, and we do
not anticipate any similar significant revenues from GPC at this time.
We
commercially launched our proprietary oncology drug FUSILEV, which was approved by the FDA
in March 2008. Shipments of FUSILEV for the period ended September 30, 2008 were approximately
$140,000. Based on our revenue recognition policy, we have deferred the recognition of this revenue
and related cost of goods sold until such time that we have a basis to reliably determine the
amount of potential returns and other credits likely to offset the gross revenues.
Research and development expenses decreased approximately $2.9 million, from approximately
$22.0 million in the nine-month period ended September 30, 2007 to approximately $19.1 million in
the nine-month period ended September 30, 2008, primarily due to the following: during the
comparative period in 2007, we made a milestone payment of approximately $1.0 million upon the
filing and acceptance of the NDA for satraplatin and because of the timeline of the next
Ozarelix study.
Selling, general and administrative expenses decreased by approximately $0.5 million, from
approximately $9.4 million in the nine-month period ended September 30, 2007 to approximately $8.9
million in the nine-month period ended September 30, 2008, primarily due to a reduction in legal
expenses from that which were incurred in 2007 in connection with the
GPC arbitration; partially offset by
increased sales and marketing expenses of approximately $3.3 million incurred in connection with
the commercial launch activities associated with FUSILEV.
Other income consisted of net interest income of approximately $556,000 and $2.3 million for
the nine-month periods ended September 30, 2008 and September 30, 2007, offset in 2008 by
approximately $250,000 realized
investment loss. The decrease in interest income was primarily due to lower investment yields
in 2008 due to the shift in our investment strategy. We expect similar yields going forward until
such time the credit markets improve.
22
SPECTRUM PHARMACEUTICALS, INC.
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 September 30, 2008 (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) |
|
$ |
574 |
|
|
$ |
132 |
|
|
$ |
289 |
|
|
$ |
153 |
|
|
|
|
|
Purchase Obligations (4) |
|
|
14,944 |
|
|
|
6,704 |
|
|
|
6,698 |
|
|
|
1,542 |
|
|
|
|
|
Contingent Milestone Obligations (5) |
|
|
64,788 |
|
|
|
275 |
|
|
|
6,580 |
|
|
|
7,225 |
|
|
$ |
50,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
80,306 |
|
|
$ |
7,111 |
|
|
$ |
13,567 |
|
|
$ |
8,920 |
|
|
$ |
50,708 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(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, such as obligations pursuant to employment agreements. |
|
(2) |
|
As of September 30, 2008, we had no capital lease obligations. |
|
(3) |
|
The operating lease obligations are primarily for 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
September 30, 2008. Over 90% of the purchase obligations consist of expenses associated with
clinical trials and related costs for Apaziquone and ozarelix for each of
the periods presented. Please see Service Agreements below for further information. |
|
(5) |
|
Milestone obligations are payable contingent upon successfully reaching certain development
and regulatory milestones as further described below under Licensing Agreements. While the
amounts included in the table above represent all of our potential cash development and
regulatory milestone obligations as of September 30, 2008, 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. |
Licensing Agreements
Almost all of our drug candidates are being developed pursuant to license agreements that
provide us with rights to certain territories to, among other things, develop, sublicense,
manufacture and sell the drugs. 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 license 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.
23
SPECTRUM PHARMACEUTICALS, INC.
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 items are 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, if at all. Accordingly, the milestone payments
represent contingent obligations that will be recorded as expense when the milestone is achieved.
While it is difficult to predict when milestones will be achieved, we estimate that if all of our
contingent milestones were successfully achieved within our anticipated timelines, our potential
contingent cash development and regulatory milestone obligations,
aggregating approximately $64.8 million as of September 30, 2008, would be due approximately as follows: $0.3 million within 12
months; $6.6 million in 2 to 3 years; $7.2 million in
4 to 5 years; and $50.7 million after 5
years. In the event these milestones are achieved, 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.
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 contracts are varied and generally obligate us to pay in
stages, depending on the occurrence of certain events specified in the contracts, such as contract
execution, reservation of service or production capacity, actual performance of service, or the
successful accrual and dosing of patients.
At each period end, we accrue for all costs of goods and services received, with such accruals
based on factors such as estimates of work performed, patient enrollment, completion of patient
studies and other events. As of September 30, 2008, we were committed under such contracts for up
to approximately $14.9 million, for future goods and services, including approximately $6.7 million
due within one year. We are in a position to accelerate, slow-down or discontinue any or all of the
projects that we are working on at any given point in time. Should we decide to discontinue and/or
slow-down the work on any project, the associated costs for those projects would get limited to the
extent of the work completed. Generally, we are able to terminate these contracts due to the
discontinuance of the related project(s) and thus avoid paying for the services that have not yet
been rendered and our future purchase obligations would reduce accordingly.
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 is
consequently 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.
24
SPECTRUM PHARMACEUTICALS, INC.
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.
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.
Upfront 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. If revenue from
sales is not reasonably determinable due to provisions for estimates, promotional adjustments,
price adjustments, returns or any other potential adjustments, we defer the revenue and recognize
revenue when the estimates are reasonably determinable, even if the monies for the gross sales have
been received.
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 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 Share-Based Employee Compensation
In estimating the fair value of share-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.
Recent Accounting Pronouncements
See Note 2: Recent Accounting Pronouncements of our accompanying consolidated financial
statements for a description of recent accounting pronouncements that have a potentially
significant impact on our financial reporting and our expectations of their impact on our results
of operations and financial condition.
25
SPECTRUM PHARMACEUTICALS, INC.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
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.
We are exposed to certain market risks. Our primary exposures relate to (1) interest rate risk
on our investment portfolio, (2) credit risk of the companies bonds in which we invest, and (3)
general credit market risks as have existed since late 2007 and have become more prominent during
2008. We manage such risks on our investment portfolio by matching scheduled investment maturities
with our cash requirements and investing in highly rated instruments.
In response to the dislocation in the credit markets since the latter part of 2007, in early
2008 we converted substantially all of our investments, including all of our market auction debt
securities, into highly liquid and safe instruments. Our investments, as of September 30, 2008,
were primarily in money market accounts, short-term corporate bonds, U.S. Treasury bills and U.S.
Treasury-backed securities. We believe the financial institutions through which we have invested
our funds are strong, well capitalized and our instruments are held in accounts segregated from the
assets of the institutions. However, due to the current extremely volatile financial and credit
markets and liquidity crunch faced by most banking institutions, the financial viability of these
institutions, and the safety and liquidity of our funds is being constantly monitored.
Because of our ability to generally redeem these investments at par at 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 September 30, 2008, any decline in the fair value
of our investments would not be material in the context of our financial statements. 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 investing in highly rated securities.
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, some of our obligations are incurred in Euros. We mitigate such risk by maintaining a limited portion of our cash in Euros and other currencies.
ITEM 4. Controls and Procedures
We have established disclosure controls and procedures (as such terms are defined in Rules
13a-15(e) and 15d-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 of 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 Rule 13a-15(b) under the Exchange Act, 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 our disclosure controls and procedures
as of September 30, 2008, the end of the period covered by this report. Based on the foregoing, our
principal executive officer and principal financial officer concluded that our disclosure controls
and procedures were effective as of September 30, 2008.
26
SPECTRUM PHARMACEUTICALS, INC.
There has been no change in our internal control over financial reporting during the quarter
ended September 30, 2008 that has materially affected, or is reasonably likely to materially
affect, our internal control over financial reporting.
PART II OTHER INFORMATION
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 the Risk Factors, included in our Form 10-K for the
fiscal year ended December 31, 2007, and in our Form 10-Q for the quarter ended March 31, 2008, as
filed with the SEC. The following risk factor is a material update to the risk factors described
in the Form 10-K.
Due to the current condition of the financial markets, our financial assets could be compromised,
and we may be unable to raise additional capital in a timely manner
We believe the financial institutions through which we have invested our funds are strong,
well capitalized and our instruments are held in accounts segregated from the assets of the
institutions. However, due to the current extremely volatile financial and credit markets and
liquidity crunch faced by most banking institutions, the financial viability of these institutions,
and the safety and liquidity of our funds is being constantly monitored. Should these financial
institutions fail to provide us with required liquidity at the time of need, we may be adversely
affected and may not be able to carry out our business plans as anticipated.
However, in light of the current volatile and tight financial and credit markets, we may not
be able to raise additional capital on favorable terms, if at all. Accordingly, we may be forced to
significantly change our business plans and restructure our operations to conserve cash, which
would likely involve out-licensing or selling some or all of our intellectual, technological and
tangible property not presently contemplated and at terms that we believe would not be favorable to
us, and/or reducing the scope and nature of our currently planned drug development activities. An
inability to raise additional capital could also impact our ability to expand operations.
27
SPECTRUM PHARMACEUTICALS, INC.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
On October 15th, 2008, we issued 25,000 shares of our common stock to the University of
Bradford, in payment for certain intellectual property rights. These securities have been issued
without registration under the Securities Act of 1933 in reliance upon the exemptions from
registration provided under Section 4(2) of the Securities Act
of 1933, as amended (the Securities Act). The
foregoing transactions did not involve any public offering; we made no solicitation in
connection with the issuances; we obtained representations from the party regarding its
investment intent, experience and sophistication; the party either received or had access to
adequate information about us in order to make an informed investment decision; and we reasonably
believed that the party was sophisticated within the meaning of Section 4(2) of the Securities
Act. No underwriting discounts or commissions were paid in conjunction with the issuances.
ITEM 6. Exhibits
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
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. |
28
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.
|
|
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|
|
SPECTRUM PHARMACEUTICALS, INC.
|
|
Date: November 7, 2008 |
By: |
/s/ Shyam K. Kumaria
|
|
|
|
Shyam K. Kumaria, |
|
|
|
Vice President, Finance
(Authorized Signatory and Principal Financial
and Accounting Officer) |
|
29
EXHIBIT INDEX
|
|
|
|
Exhibit No. |
|
Description |
|
|
|
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. |