e10vq
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
|
|
|
þ |
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended September 30, 2007
OR
|
|
|
o |
|
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)
|
|
|
Delaware
|
|
93-0979187 |
(State or other jurisdiction
|
|
(I.R.S. Employer |
of incorporation or organization)
|
|
Identification No.) |
|
|
|
157 Technology Drive |
|
|
Irvine, California
|
|
92618 |
(Address of Principal Executive Offices)
|
|
(Zip Code) |
Registrants Telephone Number, Including Area Code: (949) 788-6700
Indicate by check mark whether the Registrant (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for
such shorter period that the Registrant was required to file such reports), and (2) has been
subject to such filing requirements for the past 90 days. Yes þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer þ Non-accelerated filer o
Indicate by check mark whether the Registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act). Yes o No þ
Indicate the number of shares outstanding of each of the issuers classes of Common Stock as of the
latest practicable date:
|
|
|
Class |
|
Outstanding at October 31, 2007 |
Common Stock, $.001 par value
|
|
31,220,775 |
SPECTRUM PHARMACEUTICALS, INC.
TABLE OF CONTENTS
SPECTRUM PHARMACEUTICALS, INC.
FORM 10-Q
For the Three-month and Nine-month periods ended September 30, 2007
(Unaudited)
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
Statement Regarding Financial Information
The unaudited condensed consolidated financial statements of Spectrum Pharmaceuticals, Inc.
included herein have been prepared by management pursuant to the rules and regulations of the
Securities and Exchange Commission (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, 2006, filed with the SEC
on March 14, 2007.
3
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2007 |
|
2006 |
|
|
(In Thousands, Except Share and Per |
|
|
Share Data) |
Assets |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
3,008 |
|
|
$ |
519 |
|
Marketable securities |
|
|
62,751 |
|
|
|
50,178 |
|
Accounts Receivable, net of allowance for doubtful accounts |
|
|
1,344 |
|
|
|
1,150 |
|
Prepaid expenses and other current assets |
|
|
548 |
|
|
|
440 |
|
|
|
|
Total current assets |
|
|
67,651 |
|
|
|
52,287 |
|
Property and equipment, net |
|
|
772 |
|
|
|
625 |
|
Other Assets |
|
|
176 |
|
|
|
205 |
|
|
|
|
Total assets |
|
$ |
68,599 |
|
|
$ |
53,117 |
|
|
|
|
Liabilities and Stockholders Equity |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,522 |
|
|
$ |
2,100 |
|
Accrued compensation |
|
|
930 |
|
|
|
1,008 |
|
Accrued clinical study costs |
|
|
4,926 |
|
|
|
3,125 |
|
|
|
|
Total current liabilities |
|
|
8,378 |
|
|
|
6,233 |
|
Deferred revenue and other credits |
|
|
1,005 |
|
|
|
1,035 |
|
|
|
|
Total liabilities |
|
|
9,383 |
|
|
|
7,268 |
|
|
|
|
Commitments and Contingencies (Note 4) |
|
|
|
|
|
|
|
|
Minority Interest |
|
|
|
|
|
|
20 |
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
Preferred Stock, par value $0.001 per share, 5,000,000 shares authorized: |
|
|
|
|
|
|
|
|
Series B Junior Participating Preferred Stock, 1,000,000 shares
authorized, no shares issued and outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Series D 8% Cumulative Convertible Voting Preferred Stock, 600 shares
authorized, stated value $10,000 per share, issued and outstanding 49
shares at December 31, 2006 |
|
|
|
|
|
|
233 |
|
Series E Convertible Voting Preferred Stock, 2,000 shares authorized,
stated value $10,000 per share, $2.0 million aggregate liquidation
value, issued and outstanding, 170 shares at September 30, 2007 and
December 31, 2006 |
|
|
1,048 |
|
|
|
1,048 |
|
|
|
|
|
|
|
|
|
|
Common stock, par value $0.001 per share, 100,000,000 shares authorized: |
|
|
|
|
|
|
|
|
Issued and outstanding, 31,095,775 and 25,217,793 shares at
September 30, 2007 and December 31, 2006, respectively |
|
|
31 |
|
|
|
25 |
|
Additional paid-in capital |
|
|
286,853 |
|
|
|
251,880 |
|
Accumulated other comprehensive income |
|
|
530 |
|
|
|
357 |
|
Accumulated deficit |
|
|
(229,246 |
) |
|
|
(207,714 |
) |
|
|
|
Total stockholders equity |
|
|
59,216 |
|
|
|
45,829 |
|
|
|
|
Total liabilities and stockholders equity |
|
$ |
68,599 |
|
|
$ |
53,117 |
|
|
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
4
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Months |
|
Three-Months |
|
Nine-Months |
|
Nine-Months |
|
|
Ended |
|
Ended |
|
Ended |
|
Ended |
|
|
September 30, 2007 |
|
September 30, 2006 |
|
September 30, 2007 |
|
September 30, 2006 |
|
|
|
|
|
|
(In Thousands, Except Share and Per Share Data) |
|
|
|
|
Revenues |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Licensing and milestone revenues |
|
$ |
3,250 |
|
|
$ |
|
|
|
$ |
7,625 |
|
|
$ |
|
|
Product sales |
|
|
|
|
|
|
92 |
|
|
|
|
|
|
|
92 |
|
|
|
|
Total Revenues |
|
$ |
3,250 |
|
|
$ |
92 |
|
|
$ |
7,625 |
|
|
$ |
92 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product sold |
|
$ |
|
|
|
$ |
97 |
|
|
$ |
|
|
|
$ |
97 |
|
Research and development |
|
|
6,789 |
|
|
|
5,803 |
|
|
|
18,973 |
|
|
|
13,554 |
|
General and administrative |
|
|
2,382 |
|
|
|
1,516 |
|
|
|
7,846 |
|
|
|
4,379 |
|
Stock-based charges |
|
|
2,388 |
|
|
|
738 |
|
|
|
4,617 |
|
|
|
6,306 |
|
|
|
|
|
Total operating expenses |
|
|
11,559 |
|
|
|
8,154 |
|
|
|
31,436 |
|
|
|
24,336 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations |
|
|
(8,309 |
) |
|
|
(8,062 |
) |
|
|
(23,811 |
) |
|
|
(24,244 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income, net |
|
|
927 |
|
|
|
660 |
|
|
|
2,259 |
|
|
|
1,949 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before minority interest in consolidated
subsidiary |
|
|
(7,382 |
) |
|
|
(7,402 |
) |
|
|
(21,552 |
) |
|
|
(22,295 |
) |
Minority
interest in net loss of consolidated subsidiary |
|
|
|
|
|
|
|
|
|
|
20 |
|
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(7,382 |
) |
|
$ |
(7,402 |
) |
|
$ |
(21,532 |
) |
|
$ |
(22,293 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.24 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.76 |
) |
|
$ |
(0.93 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted weighted average common shares
outstanding |
|
|
31,034,241 |
|
|
|
24,485,369 |
|
|
|
28,276,992 |
|
|
|
23,934,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental Information |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock-based charges Components: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
1,743 |
|
|
$ |
447 |
|
|
$ |
3,052 |
|
|
$ |
5,233 |
|
General and administrative |
|
|
645 |
|
|
|
291 |
|
|
|
1,565 |
|
|
|
1,073 |
|
|
|
|
Total stock based charges |
|
$ |
2,388 |
|
|
$ |
738 |
|
|
$ |
4,617 |
|
|
$ |
6,306 |
|
|
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
5
SPECTRUM PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
Nine-Months |
|
Nine-Months |
|
|
Ended |
|
Ended |
|
|
September 30, 2007 |
|
September 30, 2006 |
|
|
(In Thousands) |
Cash Flows From Operating Activities: |
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(21,532 |
) |
|
$ |
(22,293 |
) |
Adjustments to reconcile net loss to net cash used in operating activities: |
|
|
|
|
|
|
|
|
Depreciation and amortization |
|
|
187 |
|
|
|
145 |
|
Stock-based compensation |
|
|
4,096 |
|
|
|
2,990 |
|
Fair value of common stock issued in connection with drug license |
|
|
520 |
|
|
|
3,316 |
|
Minority interest in subsidiary |
|
|
(20 |
) |
|
|
(2 |
) |
Changes in operating assets and liabilities: |
|
|
|
|
|
|
|
|
Increase in Accounts Receivable |
|
|
(194 |
) |
|
|
(927 |
) |
(Increase) Decrease in other assets |
|
|
(54 |
) |
|
|
138 |
|
Increase in accounts payable and accrued expenses |
|
|
1,673 |
|
|
|
2,536 |
|
(Decrease) in accrued compensation and related taxes |
|
|
(78 |
) |
|
|
(11 |
) |
(Decrease) in deferred revenue and other credits |
|
|
(30 |
) |
|
|
825 |
|
|
|
|
Net cash used in operating activities |
|
|
(15,432 |
) |
|
|
(13,283 |
) |
|
|
|
Cash Flows From Investing Activities: |
|
|
|
|
|
|
|
|
Purchases of marketable securities |
|
|
(12,425 |
) |
|
|
(11,060 |
) |
Purchases of property and equipment |
|
|
(334 |
) |
|
|
(161 |
) |
|
|
|
Net cash provided by (used in) investing activities |
|
|
(12,759 |
) |
|
|
(11,221 |
) |
|
|
|
Cash Flows From Financing Activities: |
|
|
|
|
|
|
|
|
Proceeds from issuance of common stock and warrants, net of
related offering costs and expenses |
|
|
30,041 |
|
|
|
|
|
Proceeds from exercise of warrants |
|
|
519 |
|
|
|
17 |
|
Proceeds from exercise of stock options |
|
|
120 |
|
|
|
|
|
|
|
|
Net cash provided by financing activities |
|
|
30,680 |
|
|
|
17 |
|
|
|
|
Net increase (decrease) in cash and cash equivalents |
|
|
2,489 |
|
|
|
(24,487 |
) |
Cash and cash equivalents, beginning of period |
|
|
519 |
|
|
|
28,750 |
|
|
|
|
Cash and cash equivalents, end of period |
|
$ |
3,008 |
|
|
$ |
4,263 |
|
|
|
|
Supplemental Cash Flow Information: |
|
|
|
|
|
|
|
|
Interest paid |
|
$ |
|
|
|
$ |
3 |
|
|
|
|
Income taxes paid |
|
$ |
|
|
|
$ |
1 |
|
|
|
|
Schedule of Non-Cash Investing and Financing Activities: |
|
|
|
|
|
|
|
|
Fair value of common stock issued in connection with drug license |
|
$ |
520 |
|
|
$ |
3,316 |
|
|
|
|
Fair value of restricted stock granted to employees and directors |
|
$ |
1,308 |
|
|
$ |
338 |
|
|
|
|
Fair value of warrants issued to consultants and placement agents |
|
$ |
|
|
|
$ |
237 |
|
|
|
|
Fair value of stock issued to match employee 401k contributions |
|
$ |
129 |
|
|
$ |
75 |
|
|
|
|
Preferred stock dividends paid with common stock |
|
$ |
12 |
|
|
$ |
55 |
|
|
|
|
The accompanying notes are an integral part of these
condensed consolidated financial statements.
6
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
1. Business and Basis of Presentation
Business
Spectrum Pharmaceuticals, Inc. (the Company) is a biopharmaceutical company engaged in the
business of acquiring and advancing a diversified portfolio of drug candidates, with a focus on
oncology, urology and other critical health needs for which there are
currently few other treatment
options.
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, 2007 are not necessarily indicative of the results that may be expected for the
year ending December 31, 2007. The balance sheet at December 31, 2006 has been derived from the
audited financial statements at that date but does not include all of the information and footnotes
required by GAAP for complete financial statements. For further information, refer to the
consolidated financial statements and footnotes thereto included in our Annual Report on Form 10-K
for the year ended December 31, 2006.
2. Summary of Significant Accounting Policies and Estimates
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and of our
wholly-owned and majority-owned subsidiaries. As of September 30, 2007, we had two subsidiaries:
Spectrum Pharmaceuticals GmbH, a wholly-owned inactive subsidiary incorporated in Switzerland in
April 1997; and NeoJB, LLC (NeoJB), 80% owned, organized in Delaware in April 2002. We have
eliminated all significant intercompany accounts and transactions.
Investments by outside parties in our consolidated subsidiary are recorded as Minority
Interest in Consolidated Subsidiary in our accounts, and stated net after allocation of income and
losses in the subsidiary.
Use of Estimates
The
preparation of financial statements in conformity with 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
stock-based charges. The estimation process requires assumptions to be made about future events and
conditions, and as such, is inherently subjective and uncertain. Actual results could differ
materially from our estimates.
Fair Value of Financial Instruments
The carrying amounts of cash and cash equivalents, marketable securities, accounts receivable,
accounts payable and accrued liabilities, as reported in the balance sheets, are considered to
approximate fair value given the short term maturity and/or liquidity of these financial
instruments.
7
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities primarily consist of bank checking deposits,
short-term treasury securities, institutional money market funds, corporate debt and equity,
municipal obligations, including market auction debt securities, government agency notes, and
certificates of deposit. We classify highly liquid short-term investments, with insignificant
interest rate risk and maturities of 90 days or less at the time of acquisition, as cash and cash
equivalents. Other investments, which do not meet the above definition of cash equivalents, are
classified as either held-to-maturity or available-for-sale marketable securities, in
accordance with the provisions of Financial Accounting Standards Board (FASB) Statement (SFAS) No.
115, Accounting for Certain Investments in Debt and Equity Securities. Investments that we intend
to hold for more than one year are classified as long-term investments.
Concentrations of Credit Risk
All of our cash, cash equivalents and marketable securities are invested at two major
financial institutions. To a limited degree these investments are insured by the Federal Deposit
Insurance Corporation (FDIC) and by third party insurance. However, these investments are not
insured against the possibility of a complete loss of earnings or principal and are inherently
subject to the credit risk related to the credit worthiness of the underlying issuer. We believe
that such risks are mitigated because we invest only in investment grade securities. We have not
incurred any significant credit risk losses related to such investments.
Patents and Licenses
We own or license all the intellectual property that forms the basis of our business model. We
expense all licensing and patent application costs as they are incurred.
Revenue Recognition
We follow the provisions as set forth by current accounting rules, which primarily include
Staff Accounting Bulletin (SAB) 104, Revenue Recognition, and Emerging Issues Task Force (EITF) No.
00-21, Accounting for Revenue Arrangements with Multiple Deliverables. Generally, revenue is
recognized when evidence of an arrangement exists, delivery has occurred or services have been
rendered, the price is fixed and determinable, and collectibility is reasonably assured.
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.
8
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
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.
Basic and Diluted Net Loss Per Share
In accordance with FASB Statement No. 128, Earnings Per Share, we calculate basic and
diluted net loss per share using the weighted average number of common shares outstanding during
the periods presented, and adjust the amount of net loss used in this calculation for preferred
stock dividends declared during the period.
We incurred a net loss in each period presented, and as such, did not include the effect of
potentially dilutive common stock equivalents in the diluted net loss per share calculation, as
their effect would be anti-dilutive for all periods. Dilutive common stock equivalents would
include the common stock issuable upon the conversion of preferred stock and the exercise of
warrants and stock options that have conversion or exercise prices below the market value of our
common stock at the measurement date. As of September 30, 2007 and 2006, all potentially dilutive
common stock equivalents amounted to approximately 16 and 15 million shares, respectively.
The following data show the amounts used in computing basic loss per share for the three-month
and nine-month periods ended September 30, 2007 and 2006.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three-Months |
|
|
Three-Months |
|
|
Nine-Months |
|
|
Nine-Months |
|
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
Ended |
|
|
|
September 30, 2007 |
|
|
September 30, 2006 |
|
|
September 30, 2007 |
|
|
September 30, 2006 |
|
|
|
|
|
|
|
(In Thousands, Except Share and Per Share Data) |
|
|
|
|
|
Net loss |
|
$ |
(7,382 |
) |
|
$ |
(7,402 |
) |
|
$ |
(21,532 |
) |
|
$ |
(22,293 |
) |
Less: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred dividends paid in cash or stock |
|
|
(10 |
) |
|
|
(26 |
) |
|
|
(12 |
) |
|
|
(81 |
) |
|
|
|
Income available to common stockholders
used in computing basic earnings per
share |
|
$ |
(7,392 |
) |
|
$ |
(7,428 |
) |
|
$ |
(21,544 |
) |
|
$ |
(22,374 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average shares outstanding |
|
|
31,034,241 |
|
|
|
24,485,369 |
|
|
|
28,276,992 |
|
|
|
23,934,749 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net loss per share |
|
$ |
(0.24 |
) |
|
$ |
(0.30 |
) |
|
$ |
(0.76 |
) |
|
$ |
(0.93 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Accounting for Stock-Based Employee Compensation
Effective January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment, using the
modified prospective transition method and, accordingly, did not restate the consolidated statements of
operations for periods prior to January 1, 2006. This pronouncement amended SFAS No. 123,
Accounting for Stock-Based Compensation, and superseded Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees. Under SFAS No. 123(R), we measure compensation
cost for all stock-based awards at fair value on the date of grant and recognize compensation
expense in our consolidated statements of operations over the service period that the awards are
expected to vest. As permitted under SFAS No. 123(R), we have elected to recognize compensation
cost for all options with graded vesting on a straight-line basis over the vesting period of the
entire option.
In estimating the fair value of stock-based compensation, we use the 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
9
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
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.
Comprehensive Loss
Comprehensive loss consists of net loss and other gains and losses affecting shareholders
equity that, under GAAP, are excluded from net loss. For the
Company, such items consist primarily of unrealized gains and losses on marketable equity
investments and foreign currency translation gains and losses.
3. Products and Strategic Alliances
Our key products under development that represent nearer term revenue and/or development
expense potential and related business alliances are described in detail in our Annual Report on
Form 10-K for the year ended December 31, 2006.
The following is a brief update of the most advanced products under development as of
September 30, 2007:
Satraplatin: During the nine-month period ended September 30, 2007, we recorded $7.2 million
in milestone revenues from GPC Biotech AG in connection with the filing and acceptance of a New Drug
Application, or NDA, by the U.S. Food and Drug Administration, or FDA, and the filing and acceptance of
a Marketing Authorization Application that was filed by a sub-licensee of GPC Biotech with
the European Medicines Agency, or EMEA. We paid Johnson Matthey an aggregate of $1 million in
milestone payments, $500,000 on the filing of the NDA and $500,000 upon the acceptance of the NDA.
On
October 30, 2007, GPC announced that the Phase 3 Satraplatin
and Prednisone Against Refractory Cancer trial evaluating
satraplatin for the treatment of hormone-refractory prostate cancer did not meet its primary
efficacy endpoint.
ISO-Vorin (LFA): During the nine-month period ended September 30, 2007, we continued
progression toward submitting a response to certain chemistry and manufacturing questions raised by
the FDA during the review of the NDA, and in July 2007, we filed with the FDA an amendment to the
NDA to address such questions. Action by the FDA is expected by early 2008. As a result of the
foregoing, during the three-month period ended September 30, 2007, we recorded $520,000 as a
stock-based research and development charge, which represents the fair market value of 125,000
shares of common stock issued in October 2007 as a milestone payment to Targent, LLC, from which we
acquired certain rights to ISO-Vorin.
EOquin®:
Under a Special Protocol Assessment procedure, we received concurrence from the FDA
for the design of the Phase 3 study protocol for EOquin in non-invasive bladder cancer. The
development plan for EOquin calls for two Phase 3 clinical studies. The first study began during
the second quarter of 2007, and the second study began during the third quarter of 2007.
Ozarelix: In January 2007, we initiated a Phase 2b study of ozarelix for the treatment of
benign prostatic hypertrophy after the FDA cleared our Investigation New Drug application, and
concurred with the study protocol. On April 30, 2007, we
completed enrollment in the trial.
Ortataxel: On July 20, 2007, we entered into a worldwide license agreement for ortataxel, a
third-generation taxane classified as a new chemical entity that has demonstrated clinical
activity against taxane-refractory tumors. We acquired these rights from Indena S.p.A., the Italian
company that discovered ortataxel, and agreed to make an upfront payment, subject to certain
conditions, plus regulatory and sales milestones, and royalties on future net sales. In October
2007, we paid Indena approximately $2.8 million in upfront license fees.
10
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
4. Commitments and Contingencies
Facility and Equipment Leases
As of September 30, 2007, we were obligated under a facility lease and several operating
equipment leases.
Minimum lease requirements for each of the next five years and thereafter, under the property
and equipment operating leases, are as follows:
|
|
|
|
|
Year ending December 31: |
|
Lease Commitments |
|
|
|
Amounts In |
|
|
|
Thousands |
|
2007 (Remainder of Year) |
|
$ |
121 |
|
2008 |
|
$ |
494 |
|
2009 |
|
$ |
253 |
|
2010 |
|
$ |
5 |
|
2011 |
|
$ |
|
|
|
|
|
|
Thereafter |
|
$ |
|
|
|
|
$ |
873 |
|
|
|
|
|
Licensing Agreements
Almost
all of our drug product candidates are being developed pursuant to license agreements
that provide us with rights to certain territories to, among other things, develop, sublicense,
and sell the drugs. We have
out-licensed development and commercialization rights to Satraplatin, one of our
drug product candidates,
to GPC Biotech in exchange for upfront and milestone payments and
royalties on sales of product. We are required to use commercially reasonable efforts to
develop the drugs, are generally responsible for all development, patent filing and maintenance
costs, sales, marketing and liability insurance costs, and are generally contingently obligated to
make milestone payments to the licensors if we successfully reach development and regulatory
milestones specified in the agreements. In addition, we are obligated to pay royalties and, in some
cases, milestone payments based on net sales, if any, after marketing approval is obtained from
regulatory authorities. Par Pharmaceutical Companies, Inc. is responsible for marketing our generic
sumatriptan injection product and we will share the profits.
The potential contingent development and regulatory milestone obligations under all our
licensing agreements are generally tied to progress through the FDA approval process, which
approval significantly depends on positive clinical trial results. The following list is typical of
milestone events: conclusion of Phase 2 or commencement of Phase 3 clinical trials; filing of new
drug applications in each of the United States, Europe and Japan; and approvals from each of the
regulatory agencies in those jurisdictions.
Given
the uncertainty of the drug development process, we are unable to predict with any
certainty when any of the milestones will occur, if at all. Accordingly, the milestone payments represent
contingent obligations that will be recorded as expense when the milestone is achieved. Our
potential contingent cash development and regulatory milestone obligations aggregate approximately
$72 million as of September 30, 2007, assuming such milestones are achieved. We may achieve certain
milestones over the next twelve months, thereby obligating us to issue up to 250,000 shares of our
common stock and to pay up to approximately $6 million in cash, including the approximately $2.8
million paid to Indena in October 2007.
Service Agreements
In connection with the research and development of our drug products, we have entered into
contracts with numerous third party service providers, such as clinical trial centers, clinical
research organizations, data monitoring centers, and with drug formulation, development and testing
laboratories. The financial terms of these agreements are varied and generally obligate us to pay
in stages, depending on achievement of certain events specified in the agreements, such as contract
execution, reservation of service or production capacity, actual performance of service,
11
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
or the successful accrual and dosing of patients. As of each period end, we accrue for all
non-cancelable installment amounts that we are likely to become obligated to pay.
Employment Agreements
We have entered into employment agreements with two of our named executive officers, Dr.
Shrotriya, President and Chief Executive Officer, and Dr. Lenaz, Chief Scientific Officer, expiring
December 31, 2008 and July 1, 2008, respectively. The employment agreements automatically renew for
a one-year term unless either party gives written notice of such partys intent not to renew the
agreement at least 90 days prior to the commencement of the next year. The employment agreements
require each officer to devote his full working time and effort to the business and affairs of the
Company during the term of the agreement. The employment agreements provide for a minimum annual
base salary with annual increases, periodic bonuses and option grants as determined by the
Compensation Committee of the Board of Directors. They also provide for severance payments and
accelerated vesting of options, upon termination of employment under certain circumstances.
Litigation
At September 30, 2007, we were in dispute with GPC Biotech. In December 2006, we filed a
demand for arbitration to address our exclusion from participating in
nearly $70 million in sublicense income received by
GPC Biotech AG, and to address other non-monetary material violations of our license agreement with
GPC, and GPC answered and counterclaimed and demanded a royalty-free
license among other requests. The arbitration hearing was conducted in
Boston, Massachusetts, between July 6 and July 13, 2007, and final arguments were presented on August
21.
On November 5, the arbitration panel issued a ruling whereby it dismissed all claims of each party
against the other. The panels ruling is binding according to the terms of the license
agreement between us and GPC.
We are party to various other legal proceedings arising from the ordinary course of business.
Although the ultimate resolution of these various proceedings cannot be determined at this time, we
do not believe that such proceedings, individually or in the aggregate, will have a material
adverse effect on our future consolidated results of operations, cash flows or financial condition.
5. Stockholders Equity
Common Stock
On May 11, 2007, we sold 5,134,100 shares of our common stock at a purchase price of $6.25 per
share for net cash proceeds of approximately $30 million, after placement agent fees and other
offering costs of approximately $2,100,000. No warrants were issued in connection with this
offering.
Common Stock Reserved for Future Issuance
As of September 30, 2007, approximately 16 million shares of common stock were issuable upon
conversion or exercise of rights granted under prior financing arrangements and stock options and
warrants, as follows:
|
|
|
|
|
Conversion of Series E preferred shares |
|
|
340,000 |
|
Exercise of stock options |
|
|
5,922,760 |
|
Exercise of warrants |
|
|
9,703,831 |
|
|
|
|
|
|
|
|
|
|
|
Total shares of common stock reserved for future issuances |
|
|
15,966,591 |
|
|
|
|
|
|
In the event that all the foregoing options and warrants were exercised, we would receive up
to approximately $98 million from the issuance of shares of our common stock.
12
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
Stock-Based Compensation
As of September 30, 2007, approximately 2.5 million incentive award shares were available for
grant under our stock-based incentive award plan. Stock-based awards generally vest over periods of
up to four years and have a ten-year life.
Presented below is a summary of activity, for all of our stock-based incentive award plans,
during the nine-month period ended September 30, 2007:
Stock Options:
During the nine-month period ended September 30, 2007, 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, 2007 was estimated at approximately $3.74, 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 68.1%; risk free interest
rate of 4.74%; and an expected life of five years.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
Weighted |
|
Aggregate |
|
|
Common |
|
Average |
|
Average |
|
Intrinsic |
|
|
Stock |
|
Exercise |
|
Remaining Term |
|
Value |
|
|
Options |
|
Price |
|
(In Years) |
|
(In Thousands) |
Outstanding at beginning of year |
|
|
4,640,252 |
|
|
$ |
5.86 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Granted |
|
|
1,378,200 |
|
|
$ |
6.18 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expired |
|
|
(2,454 |
) |
|
$ |
23.77 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forfeited |
|
|
(11,800 |
) |
|
$ |
5.38 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercised |
|
|
(81,438 |
) |
|
$ |
1.48 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Outstanding, at the end of period |
|
|
5,922,760 |
|
|
$ |
5.99 |
|
|
|
7.58 |
|
|
$ |
1,275 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vested and expected to vest, at
end of period |
|
|
5,693,930 |
|
|
$ |
5.99 |
|
|
|
7.54 |
|
|
$ |
1,272 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exercisable, at the end of period |
|
|
3,634,460 |
|
|
$ |
6.00 |
|
|
|
6.86 |
|
|
$ |
1,249 |
|
|
|
|
The aggregate intrinsic value in the table above represents the total difference between the
Companys closing common stock price of $4.22 on September 30, 2007 and the exercise price,
multiplied by the number of all in-the-money options, that would have been received by the option
holders had all option holders exercised their options on September 30, 2007. This amount changes
based on the fair market value of the Companys common stock.
During the nine-month period ended September 30, 2007, the stock-based charge in connection
with the expensing of stock options was $3.2 million. As of September 30, 2007, there was $8.5
million of unrecognized stock-based compensation cost related to stock options which is expected to
be recognized over a weighted average period of 2.37 years.
13
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
September 30, 2007
(Unaudited)
Restricted Stock:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
Restricted |
|
Average |
|
|
Stock |
|
Grant date |
|
|
Awards |
|
Fair Value |
|
|
|
Nonvested at beginning of period |
|
|
146,250 |
|
|
$ |
4.25 |
|
|
Granted |
|
|
265,000 |
|
|
$ |
5.56 |
|
|
|
|
|
|
|
|
|
|
Vested |
|
|
(133,750 |
) |
|
$ |
5.22 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Nonvested at the end of period |
|
|
277,500 |
|
|
$ |
5.03 |
|
|
|
|
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, 2007, the stock-based charge in connection
with the expensing of restricted stock awards was $708,000. As of September 30, 2007, there was
$257,000 of unrecognized stock-based compensation cost related to nonvested restricted stock
awards, which is expected to be recognized over a weighted average period of 1.26 years.
401(k) Plan Matching Contribution:
During the nine-month period ended September 30, 2007, we issued 31,095 shares of common stock
as the Companys match of approximately $175,000 on the 401(k) contributions of its employees
during the fourth quarter of 2006, and the nine-month period ended September 30, 2007.
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, 2007:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted |
|
|
|
Common Stock |
|
|
Average Exercise |
|
|
|
Warrants |
|
|
Price |
|
Outstanding at beginning of period |
|
|
9,917,077 |
|
|
$ |
6.71 |
|
Granted |
|
|
|
|
|
|
|
|
Repurchased |
|
|
|
|
|
|
|
|
Exercised |
|
|
(161,145 |
) |
|
$ |
3.22 |
|
Forfeited |
|
|
|
|
|
|
|
|
Expired |
|
|
(52,102 |
) |
|
$ |
57.85 |
|
|
|
|
Outstanding, at the end of period |
|
|
9,703,831 |
|
|
$ |
6.49 |
|
|
|
|
Exercisable, at the end of period |
|
|
9,583,831 |
|
|
$ |
6.51 |
|
|
|
|
14
SPECTRUM PHARMACEUTICALS, INC.
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended, in reliance upon the safe harbor provisions of the Private
Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding
our future product development activities and costs, the revenue potential (licensing, royalty and
sales) of our product candidates, the safety and efficacy of our drug products, the 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 below, including under Risk
Factors as well as those discussed in our periodic reports filed with the Securities and Exchange
Commission including our Annual Report on Form 10-K. These factors include, but are not limited to:
|
|
|
our ability to successfully develop, obtain regulatory approvals for and market our
products; |
|
|
|
|
our ability to generate and maintain sufficient cash resources to fund our business; |
|
|
|
|
our ability to enter into strategic alliances with partners for manufacturing,
development and commercialization; |
|
|
|
|
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 changing economic conditions. |
We do not plan to update any such forward-looking statements and expressly disclaim any duty
to update the information contained in this report except as required by law.
You should read the following discussion of the financial condition and results of our
operations in conjunction with the condensed consolidated financial statements and the notes to
those financial statements included in Item I of Part 1 of this report.
15
Overview
We are a biopharmaceutical company that acquires and advances a diversified portfolio of drug
candidates, with a focus on oncology, urology and other unmet medical
needs for which there
are currently few other treatment options.
16
SPECTRUM PHARMACEUTICALS, INC.
In general, we direct and pay for all aspects of the drug development process, and
consequently incur the risks and rewards of drug development, which is an inherently uncertain
process. To mitigate such risks, we enter into alliances where we believe that our partners can
provide strategic advantage in the development, manufacturing or distribution of our drugs. In such
situations, the alliance partners may share in the risks and rewards of the drug development and
commercialization.
Business Outlook
Our primary business focus continues to be to acquire, develop and commercialize a portfolio
of marketable prescription drug products with a mix of near-term and long-term revenue potential.
The following is an update for some of our projects:
|
|
|
Satraplatin: On October 30, 2007, our licensee, GPC Biotech AG, announced that the
Phase 3 SPARC trial evaluating satraplatin for the treatment of hormone-refractory prostate
cancer did not meet its primary efficacy endpoint. GPC has stated publicly that it is
evaluating its future development plans for satraplatin. |
|
|
|
|
Pharmion Corporation, GPCs sublicense for Europe and certain other countries, has publicly
stated that it plans to review the data from the trial and work closely with the European
Medicines Agency, or EMEA, to determine the next steps for the Marketing Authorization
Application that was submitted to the EMEA in June 2007. |
|
|
|
|
ISO-Vorin (LFA): In July 2007, we filed with the FDA an amendment to the NDA
to address certain chemistry and manufacturing questions raised by the FDA during the
review of the NDA. The FDA target date for action is in January 2008. We also plan to file
an NDA amendment for the oral formulation. If we receive approval
from the FDA for the use after the administration of high-dose
methotrexate in treating osteogenic sarcoma, we plan to file a supplemental application
for the treatment of advanced metastatic colorectal cancer in combination with 5-fluorouracil. |
|
|
|
|
EOquin®:
In 2007, we
have initiated two Phase 3 clinical studies in the United States for EOquin in non-invasive
bladder cancer, and have been, and will continue to enroll patients
in these trials. We have enrolled more than 170 patients into the two
trials. In
early 2008, we anticipate expanding one of the clinical studies to sites in Canada. |
|
|
|
|
Ozarelix: In January 2007, we initiated a Phase 2b study of ozarelix for the
treatment of benign prostatic hypertrophy, or BPH, following a European study in 144
patients in BPH. This current study is being undertaken to help design the protocol for
the registrational study in the U.S. On April 30, 2007, we completed enrollment of
the trial. While we wait for the data, we are concurrently working on the design of the
protocol for the registrational study which is expected to initiate
in early 2008. |
|
|
|
|
Ortataxel: In July 2007, we entered into a worldwide license agreement for
ortataxel, a third-generation taxane classified as a new chemical entity that has
demonstrated clinical activity against taxane-refractory tumors. We acquired these rights
from Indena S.p.A., the Italian company that discovered ortataxel,
and have made an
upfront payment, and are obligated to pay regulatory and sales milestones, and
royalties on future net sales. Ortataxel belongs to a new generation of taxanes with the
potential to be active against tumors resistant to Bristol-Myers Squibbs Taxol®
(paclitaxel) and Sanofi-Aventis Taxotere® (docetaxel).
We plan to initiate
a phase 2 study in non-small cell lung cancer in 2008 and to
also develop and test our own oral formulation for better bioavailability. |
|
|
|
|
SPI-1620: In July 2007, we filed an IND application with the FDA for the use of
SPI-1620 in patients with recurrent or progressive carcinoma. SPI-1620 is being developed
as an adjunct to chemotherapy. In August 2007, the FDA cleared our IND paving the way to
begin a Phase 1 open label, dose-escalating study assessing the safety, tolerability,
pharmacokinetics and pharmocodynamic in patients with recurrent or progressive carcinoma.
We anticipate initiating this study before the end of the year. |
|
|
|
|
Sumatriptan injection: In November 2006, we reached an agreement with GSK to
settle the patent litigation relating to sumatriptan injection. The terms of the agreement
provide that we may exclusively distribute authorized generic versions of certain
sumatriptan injection products in the United States with an expected launch during GSKs
sumatriptan pediatric exclusivity period, which begins on August 6, 2008, but with the |
17
SPECTRUM PHARMACEUTICALS, INC.
|
|
|
launch occurring not later than November 6, 2008. Par
Pharmaceutical Companies, our partner for
the sale and distribution of sumatriptan injection, will market the drug on our behalf. |
|
|
|
|
We expect to continue to evaluate additional promising drug product candidates for
acquisition or license. |
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, 2007, have exceeded $220 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 $66 million in cash, cash equivalents and marketable
securities that we had on hand as of September 30, 2007 will allow us to fund our current planned
operations for at least the next twelve months. Our long-term strategy is to generate profits from
the sale and licensing of our drug products. In the next several years, we expect to supplement our
cash position with: sales of ISO-Vorin, if approved by FDA; licensing revenues from out-licensing
our other drug products; and profits from the sale by Par of the authorized generic versions of
certain sumatriptan injection products.
However, if we are unable to generate the revenues necessary to finance our operations
long-term, we may have to seek additional capital through the sale of our equity, which we may
issue at any time, as appropriate. Our operations have historically been financed by the issuance
of capital stock. In May 2007, we received net proceeds of approximately $30 million from the sale
of 5,134,100 common shares in an offering pursuant to a shelf registration statement. In addition,
we could receive a significant amount of cash from the exercise of outstanding warrants and
options, if the price of our common stock appreciates. It is generally difficult to fund
pharmaceutical research and development via borrowings due to the significant expenses involved,
lack of revenues sufficient to service debt and the significant inherent uncertainty as to results
of research and the timing of those results.
As described elsewhere in this report, as well as the risk factors in our 2006 Annual Report
on Form 10-K, our drug development efforts are subject to the considerable uncertainty inherent in
any new drug development. Due to the uncertainties involved in progressing through clinical trials,
and the time and cost involved in obtaining regulatory approval and in establishing collaborative
arrangements, among other factors, we cannot reasonably estimate the timing and ultimate aggregate
cost of developing each of our drug product candidates. We are similarly unable to reasonably
estimate when, if ever, we will realize material net cash inflows from sales of our drug products.
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 upfront license fees, milestone payments, active pharmaceutical ingredients, clinical trials,
patent related legal costs, and product liability insurance) and non-product
specific, or indirect, costs. During the nine-month period ended September 30, 2007, our total
research and development expenditure, excluding stock-based charges of approximately $3.1 million,
was approximately $19 million, including approximately $13 million in direct costs. The
principal components of such direct expenses were direct costs related to ozarelix approximately
$4.4 million, EOquin approximately $4.9 million, and satraplatin milestones $1 million.
While we are currently focused on advancing each of our product development programs, we
anticipate that we will make determinations as to which programs, if any, to pursue and how much
funding to direct to each program on an ongoing basis in response to the scientific and clinical
success of each product candidate, as well as an ongoing assessment as to the product candidates
commercial potential.
In addition to our present portfolio of drug product candidates, we continually evaluate
proprietary products for acquisition. If we are successful in acquiring rights to additional
products, we may pay up-front licensing fees in cash, and our research and development expenditures
would likely increase.
Under our various existing licensing agreements, we are contingently obligated to make
milestone payments. In connection with the development of certain in-licensed drug products, we may
achieve certain of these milestones over the next twelve months. Upon successful achievement of
these milestones, we will become obligated to issue
18
SPECTRUM PHARMACEUTICALS, INC.
up to 250,000 shares of our common stock and pay up to approximately $6 million in cash,
including the approximately $2.8 million paid to Indena in October 2007.
Net Cash used in Operating Activities
During the nine-month period ended September 30, 2007, net cash used in operations was
approximately $15.4 million. Our anticipated net use of cash for operations in the fiscal year
ending December 31, 2007, excluding the cost of in-licensing additional drugs, if any, is expected
to range between approximately $25 and $30 million. This estimate is subject to considerable
uncertainty and depends on the following key factors: continued positive results from our
preclinical and clinical studies; the outcome of discussions with the FDA regarding our planned
clinical trials; and the initiation of clinical trials and patient enrollment as anticipated.
Further, while we do not receive any funding from third parties for research and development that
we conduct, co-development
agreements with other companies for any of our drug product candidates may reduce our
expenses.
Net Cash Used for Investing Activities
While cash preservation is our primary investment goal, in order to maximize the interest
yield on our investments, we place our cash in a variety of investments pending its use in our
business. Net cash used for investing activities was approximately $12.8 million during the
nine-month period ended September 30, 2007, and resulted from
investment in marketable securities,
of the approximately $30 million net proceeds from the May 2007 financing, offset by the conversion
of marketable securities to cash for use in operations, and capital expenditures of $334,000 to
support operations.
Net Cash provided by and used for Financing Activities
Net
cash provided by financing activities totaled approximately $30.7 million for the nine-month
period ended September 30, 2007. Approximately $30 million
derived from the sale of
5,134,100 shares of common stock, and approximately $639,000 derived from the exercise of outstanding
warrants for 161,145 shares of our common stock, and the exercise of stock options for 81,438
shares of our common stock.
Results of Operations
Results of Operations for the three-month period ended September 30, 2007 compared to the
three-month period ended September 30, 2006
For each of the three-month periods ended September 30, 2007 and 2006, we incurred a net loss
of approximately $7.4 million. 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.
The milestones were related to the filing and acceptance of a Marketing Authorization Application
by Pharmion with the EMEA. During the three-month period ended September 30, 2006 we had
approximately $92,000 of product sales.
Research and development expenses increased approximately $1.0 million, from approximately
$5.8 million in the three-month period ended September 30, 2006 to approximately $6.8 million in
the three-month period ended September 30, 2007, due to the expanded scope of our clinical
development activities, including an increase in the number of
personnel, related to the two Phase
3 trials for EOquin®, which initiated during 2007.
General and administrative expenses increased by approximately $0.9 million, from
approximately $1.5 million in the three-month period ended September 30, 2006 to approximately $2.4
million in the three-month period ended September 30, 2007, primarily due to increased legal
expenses resulting from the arbitration we initiated against GPC Biotech, described elsewhere in
this report.
Stock-based
charges increased by approximately $1.7 million, from approximately $0.7 million
in the three-month period ended September 30, 2006 to approximately $2.4 million in the three-month
period ended September
19
SPECTRUM PHARMACEUTICALS, INC.
30, 2007. $520,000 of the increase represents the fair market value of the 125,000 shares
payable to Targent, LLC, pursuant to achievement of a milestone in the three-month period ended
September 30, 2007. The balance of the increase, $1.2 million, represents an increase in the
expensing of equity grants in accordance with SFAS 123(R).
Other income primarily consisted of net interest income of approximately $0.7 million for each
of the three-month periods ended September 30, 2007 and September 30, 2006.
Results of Operations for the nine-month period ended September 30, 2007 compared to the
nine-month period ended September 30, 2006
For the nine-month period ended September 30, 2007, we incurred a net loss of approximately
$21.5 million compared to a net loss of approximately $22.2 million in the nine-month period ended
September 30, 2006. The principal components of the year to year changes in line items are
discussed below.
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 Biotech.
The $7.2 million in milestone payments related to the acceptance by the FDA of an NDA filing by GPC
Biotech, and the filing and acceptance of a Marketing Authorization Application with the EMEA.
Approximately $0.4 million of the recorded revenues represent amounts received from GPC Biotech
under our agreement for commissions on drug products used by GPC Biotech in clinical trials and for
commercial launch. During the nine-month period ended September 30, 2006, we had $92,000 of product sales.
Research and development expenses increased approximately $5.4 million from approximately
$13.6 million in the nine-month period ended September 30, 2006 to approximately $19 million in the
nine-month period ended September 30, 2007, due primarily to the expanded scope of our clinical
development activities, including an increase in the number of
personnel related to the two Phase 3
trials for
EOquin®,
which initiated during 2007. Approximately $1.0 million of the
increase is attributable to the payment of milestones upon the filing and acceptance of the NDA for
satraplatin.
General and administrative expenses increased by approximately $3.4 million, from
approximately $4.4 million in the nine-month period ended September 30, 2006 to approximately $7.8
million in the nine-month period ended September 30, 2007, primarily due to increased legal
expenses resulting from the arbitration we initiated against GPC Biotech, described elsewhere in
this report.
Stock-based
charges decreased by approximately $1.7 million, from approximately $6.3 million
in the nine-month period ended September 30, 2006 to approximately $4.6 million in the nine-month
period ended September 30, 2007, primarily due to the charge in 2006 of approximately $3.3 million
relating to the issuance of common stock to Targent, LLC. in connection with the acquisition of its oncology
assets and the issuance of common stock to Altair Nanotechnologies, Inc. in connection with the
payment of a milestone under our license agreement for RenaZorb and for transfer of technology
related to formulation improvements to RenaZorb developed by
Altair, offset by a charge in 2007 of
$520,000 representing the fair market value of the 125,000 shares payable to Targent pursuant to
achievement of a milestone in the nine-month period ended September 30, 2007 and an increase of
approximately $1.2 million in the expensing of equity grants in
accordance with SFAS 123(R).
Other income primarily consisted of net interest income of approximately $2.0 million for each
of the nine-month periods ended September 30, 2007 and September 30, 2006.
20
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, 2007 (in thousands):
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Less than |
|
|
|
|
|
|
|
|
|
After |
|
|
Total |
|
1 Year |
|
1-3 Years |
|
4-5 Years |
|
5 Years |
Contractual Obligations (1) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Capital Lease Obligations (2) |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Lease Obligations (3) |
|
|
873 |
|
|
|
489 |
|
|
|
384 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purchase Obligations (4) |
|
|
11,943 |
|
|
|
8,437 |
|
|
|
3,506 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contingent Milestone Obligations (5) |
|
|
72,488 |
|
|
|
6,738 |
|
|
|
5,545 |
|
|
|
26,415 |
|
|
|
33,790 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total |
|
$ |
85,304 |
|
|
$ |
15,664 |
|
|
$ |
9,435 |
|
|
$ |
26,415 |
|
|
$ |
33,790 |
|
|
|
|
|
|
|
(1) |
|
The table of contractual and commercial obligations excludes contingent payments that we may
become obligated to pay upon the occurrence of future events whose outcome is not readily
predictable. |
|
(2) |
|
As of September 30, 2007, we had no capital lease obligations. |
|
(3) |
|
The operating lease obligations are primarily the facility lease for our corporate office,
which extends through June 2009. |
|
(4) |
|
Purchase Obligations represent the amount of open purchase orders and contractual commitments
to vendors, for products and services that have not been delivered, or rendered, as of
September 30, 2007. |
|
(5) |
|
Milestone Obligations are payable contingent upon successfully reaching certain development
and regulatory milestones. While the amounts included in the table above represent all of our
potential cash development and regulatory milestone obligations as of September 30, 2007,
given the unpredictability of the drug development process, and the impossibility of
predicting the success of current and future clinical trials, the timelines estimated above do
not represent a forecast of when payment milestones will actually be reached, if at all.
Rather, they assume that all development and regulatory milestones under all of our license
agreements are successfully met and represent our best estimates of the timelines. If
the milestones are met, we believe the increase in the potential
value of the related drug product will likely significantly exceed the amount of the milestone
obligation. |
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.
21
SPECTRUM PHARMACEUTICALS, INC.
The SEC defines critical accounting policies as those that are, in managements view, most
important to the portrayal of our financial condition and results of operations and most demanding
of our judgment. We consider the following policies to be critical to an understanding of our
consolidated financial statements and the uncertainties associated with the complex judgments made
by us that could impact our results of operations, financial position and cash flows.
Cash, Cash Equivalents and Marketable Securities
Cash,
cash equivalents and marketable securities primarily consist of bank checking deposits,
short-term treasury securities, 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. Investments that do not meet the above definition of cash equivalents are
classified as either held-to-maturity or available-for-sale marketable securities, in
accordance with the provisions of Financial Accounting Standards Board, or FASB, Statement, or
SFAS, No. 115, Accounting for Certain Investments in Debt and Equity Securities. Investments that
we intend to hold for more than one year are classified as long-term investments.
Patents and Licenses
We own or license all the intellectual property that forms the basis of our business model. We
expense all licensing and patent application costs as they are incurred.
Revenue Recognition
We follow the provisions as set forth by current accounting rules, which primarily include
Staff Accounting Bulletin (SAB) 104, Revenue Recognition, and Emerging Issues Task Force (EITF)
No. 00-21, Accounting for Revenue Arrangements with Multiple Deliverables. Generally, revenue is
recognized when evidence of an arrangement exists, delivery has occurred or services have been
rendered, the price is fixed and determinable, and collectibility is reasonably assured.
Up-front fees representing non-refundable payments received upon the execution of licensing or
other agreements are recognized as revenue upon execution of the agreements where we have no
significant future performance obligations and collectibility of the fees is reasonably assured.
Milestone payments, which are generally based on developmental or regulatory events, are recognized
as revenue when the milestones are achieved, collectibility is reasonably assured, and we have no
significant future performance obligations in connection with the milestone. If
we have collected fees or milestone payments but have significant future performance
obligations related to the development of the drug product, we record deferred revenue and
recognize it over the period of our future obligations.
Revenue
from sales of product is recognized upon shipment of product when title and risk of
loss have transferred to the customer and provisions for estimates, including promotional
adjustments, price adjustments, returns, and other potential adjustments are reasonably
determinable. Such revenue is recorded, net of such estimated provisions, at the minimum amount of
the customers obligation to us. We state the related accounts receivable at net realizable value,
with any allowance for doubtful accounts charged to general operating expenses.
Research and Development
Research and development expenses are comprised of the following types of costs incurred in
performing research and development activities: personnel expenses; facility costs; contract
services; license fees and milestone payments; costs of clinical trials; laboratory supplies and
drug products; and allocations of corporate costs. We expense all research and development activity
costs in the period incurred. We review and accrue clinical study expenses based on factors such as
estimates of work performed, patient enrollment, completion of patient studies 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.
22
SPECTRUM PHARMACEUTICALS, INC.
Accounting for Stock-Based Employee Compensation
Effective January 1, 2006, we adopted SFAS No. 123(R), Share-Based Payment, using the
modified prospective transition method, and, accordingly, we did not restate the consolidated statements of
operations for periods prior to January 1, 2006. This pronouncement amended SFAS No. 123,
Accounting for Stock-Based Compensation, and superseded Accounting Principles Board (APB) Opinion
No. 25, Accounting for Stock Issued to Employees. Under SFAS No. 123(R), we measure compensation
cost for all stock-based awards at fair value on the date of grant and recognize compensation
expense in our consolidated statements of operations over the service period that the awards are
expected to vest. As permitted under SFAS No. 123(R), we have elected to recognize compensation
cost for all options with graded vesting on a straight-line basis over the vesting period of the
entire option.
In estimating the fair value of stock-based compensation, we use the quoted market price of
our common stock for stock awards and the Black-Scholes Option Pricing Model for stock options and
warrants. We estimate future volatility based on past volatility of our common stock, and we
estimate the expected length of options based on several criteria, including the vesting period of
the grant and the expected volatility.
New Accounting Pronouncements
In July 2006, the FASB issued FASB Interpretation No. 48, Accounting for Uncertainty in
Income Taxes, an interpretation of FASB Statement No. 109 (FIN 48). FIN 48 clarifies the
accounting for uncertainty in income taxes by prescribing the recognition threshold a tax position
is required to meet before being recognized in the financial statements. It also provides guidance
on derecognition, classification, interest and penalties, accounting in interim periods,
disclosure, and transition. FIN 48 was effective for fiscal years beginning after December 15,
2006. The adoption of FIN 48 did not have a material impact on our financial statements.
In September 2006, FASB Statement No. 157 Fair Value Measurement, or SFAS 157, was issued.
This Statement defines fair value, establishes a framework for measuring fair value in generally
accepted accounting principles, or GAAP, and expands disclosures about fair value measurements. The
Statement is effective January 1, 2008 for the company. We do not expect the implementation of
SFAS 157 to have a material impact on our financial statements.
In February 2007, FASB Statement No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, including an amendment of FASB Statement No. 115, or SFAS 159, was issued.
This Statement permits us to choose to measure many financial instruments and certain other items
at fair value. It also establishes presentation and disclosure requirements. This Statement is
effective January 1, 2008 for the company. We are currently evaluating the impact, if any, this
standard will have on our financial statements.
In June 2007, EITF 07-3 Accounting for Nonrefundable Advance Payments for Goods or Services
Received for Use in Future Research and Development Activities, or EITF 07-3, was issued. EITF 07-3
provides that nonrefundable advance payments made for goods or services to be used in future
research and development activities should be deferred and capitalized until the
related goods or services are delivered or are performed, when the amounts would be
recognized as an expense. This standard is effective for new contracts entered into after
January 1, 2008. We are currently evaluating the potential impact, if any, this standard will have
on our financial statements.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to certain market risks associated with interest rate fluctuations and credit
risk on our cash equivalents and marketable securities, which investments are entered into for
purposes other than trading. While the primary objective of our investment activities is to
preserve principal, we seek to maximize yields without significantly increasing risk. We do not
utilize hedging contracts or similar instruments.
Our primary exposures relate to (1) interest rate risk on our investment portfolio, and (2)
credit risk of the companies bonds in which we invest. We manage interest rate risk on our
investment portfolio by matching scheduled investment maturities with our cash requirements.
23
SPECTRUM PHARMACEUTICALS, INC.
Our investments as of September 30, 2007 are primarily in floating rate securities, short-term
government securities and money market accounts. Because of our ability to redeem these investments
at par with short notice, changes in interest rates would have an immaterial effect on the fair
value of these investments. If a 10% change in interest rates were to have occurred on September
30, 2007, any decline in the fair value of our investments would not be material. In addition, we
are exposed to certain market risks associated with credit ratings of corporations whose corporate
bonds we may purchase from time to time. If these companies were to experience a significant
detrimental change in their credit ratings, the fair market value of such corporate bonds may
significantly decrease. If these companies were to default on these corporate bonds, we may lose
part or our entire principal. We believe that we effectively manage this market risk by
diversifying our investments and selecting securities that generally have third party insurance
coverage in the event of default by the issuer.
In addition, we are exposed to foreign currency exchange rate fluctuations relating to
payments we make to vendors, suppliers and license partners using foreign currencies. In
particular, we have foreign expenses associated with our ongoing clinical studies in Europe, where
some of our obligations are incurred in Euros. We mitigate such risk by maintaining a limited
portion of our cash in Euros. Although fluctuations in exchange rates affect on our payment
obligations, they have not materially affected on our financial condition or results
of operations as of or for the nine-month period ended September 30, 2007.
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 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, 2007, the end of the period covered by this report, or
the Evaluation Date. Based on the foregoing, our Principal Executive Officer and Principal
Financial Officer concluded that our disclosure controls and procedures were effective as of the
Evaluation Date.
There has been no change in our internal control over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal control over financial reporting.
24
SPECTRUM PHARMACEUTICALS, INC.
PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
Arbitration with GPC Biotech
In December 2006, we filed a demand for arbitration to address our exclusion from
participating in nearly $70 million in sublicense income received by GPC Biotech AG, and to address other non-monetary
material violations of our license agreement with GPC, and GPC answered and
counterclaimed and demanded a royalty-free license among other requests. The arbitration hearing was conducted in Boston, Massachusetts, between July 6 and
July 13, 2007, and final arguments were presented on August 21. On November 5, the arbitration panel issued a ruling whereby it dismissed all claims of each party
against the other. The panels ruling is binding according to the terms of the license agreement between us and GPC.
Additional information regarding
this arbitration can be found in our Annual Report on Form
10-K filed with the Securities and Exchange Commission on March 14, 2007, and
our Quarterly Reports
on Form 10-Q filed on May 2, 2007 and August 9, 2007.
Other
We are involved in various other legal proceedings arising from the ordinary course of
business.
ITEM IA. Risk Factors
There have been no material changes in our assessment of risk factors affecting our business
since those presented in our Annual Report on Form 10-K, Item 1A, for the fiscal year December 31,
2006, and in our Quarterly Report on Form 10-Q, Item 1A, for the quarter
ended March 31, 2007, as filed with the SEC.
ITEM 2. Unregistered Sales of Equity Securities and Use of Proceeds
On October 15, 2007, as required by an asset purchase agreement with Targent, Inc. (Targent), we
issued 125,000 shares of our common stock as directed by Targent. We acquired the oncology assets
of Targent in March 2006, and our asset purchase agreement with Targent requires us to issue shares
as directed by Targent upon the achievement of certain milestones. The first such milestone was
achieved this quarter. We received no cash proceeds in connection with this issuance. We believe
the issuance of the shares was exempt from registration under the Securities Act of 1933, as
amended (the Securities Act), pursuant to Section 4(2) of the Securities Act. We made no
solicitation in connection with the issuance of the shares; we obtained representations from
Targent regarding its status as an accredited investor; and Targent had access to adequate
information about us in order to make an informed investment decision. No underwriting discounts or
commissions were paid in conjunction with the issuance.
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Submission of Matters to a Vote of Security Holders
Information regarding our Annual Meeting of Stockholders on July 20, 2007, was provided in Part II,
Item 4, of our quarterly report on Form 10-Q filed with the Securities and Exchange Commission on
August 9, 2007.
ITEM 5. Other Information (not previously reported in a Form 8-K)
None
ITEM 6. Exhibits
|
|
|
Exhibit No. |
|
Description |
10.1
|
|
2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.3 to Form 10-Q, as
filed with the Securities and Exchange Commission on August 9, 2007, and incorporated herein
by reference.) |
|
|
|
10.2 *
|
|
Summary of Director Compensation. (Filed as Exhibit 10.4 to Form 10-Q, as filed with the
Securities and Exchange Commission on August 9, 2007, and incorporated herein by reference.) |
25
SPECTRUM PHARMACEUTICALS, INC.
|
|
|
Exhibit
No.
|
|
Description |
10.3 + #
|
|
First Amendment to License Agreement Dated
August 28, 2001 between Johnson Matthey PLC and
Registrant dated September 30, 2002. (Filed as Exhibit 10.8 to Form 10-Q, as filed with the
Securities and Exchange Commission on November 13, 2002.)
|
|
|
|
10.4 + #
|
|
License Agreement by and between the Registrant and Indena, S.p.A. dated as of July 17, 2007. |
|
|
|
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. |
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
+ |
|
Filed herewith |
|
# |
|
Confidential portions omitted and filed separately with the U.S. Securities and Exchange
Commission
pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of 1934, as amended. |
26
SPECTRUM PHARMACEUTICALS, INC.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned thereunto duly authorized.
|
|
|
|
|
|
SPECTRUM PHARMACEUTICALS, INC.
|
|
Date: November 9, 2007 |
By: |
/s/ Shyam K. Kumaria
|
|
|
|
Shyam K. Kumaria, Vice President, Finance |
|
|
|
(Authorized Signatory and Principal Financial
and Accounting Officer) |
|
|
27
EXHIBIT INDEX
|
|
|
Exhibit No. |
|
Description |
10.1
|
|
2003 Amended and Restated Incentive Award Plan. (Filed as Exhibit 10.3 to Form 10-Q, as
filed with the Securities and Exchange Commission on August 9, 2007, and incorporated herein
by reference.) |
|
|
|
10.2 *
|
|
Summary of Director Compensation. (Filed as Exhibit 10.4 to Form 10-Q, as filed with the
Securities and Exchange Commission on August 9, 2007, and incorporated herein by reference.) |
|
|
|
10.3 + #
|
|
First Amendment to License Agreement Dated
August 28, 2001 between Johnson Matthey PLC and
Registrant dated September 30, 2002. (Filed as Exhibit 10.8 to Form 10-Q, as filed with the
Securities and Exchange Commission on November 13, 2002.) |
|
|
|
10.4 + #
|
|
License Agreement by and between the Registrant and Indena, S.p.A. dated as of July 17, 2007. |
|
|
|
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. |
|
|
|
* |
|
Indicates a management contract or compensatory plan or arrangement. |
|
+ |
|
Filed herewith |
|
# |
|
Confidential portions omitted and filed separately with the U.S. Securities and
Exchange Commission pursuant to Rule 24b-2 promulgated under the Securities Exchange Act of
1934, as amended. |