UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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 March 31, 2005
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.
Delaware
(State or other jurisdiction
of incorporation or organization)
93-0979187
(I.R.S. Employer
Identification No.)
157 Technology Drive
Irvine, California
(Address of Principal Executive Offices)
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 an accelerated filer (as defined in Rule 12B-2 of the Exchange Act).
Yes þ | No o |
Indicate the number of shares outstanding of each of the issuers classes of Common Stock as of the latest practicable date:
Class | Outstanding at May 9, 2005 | |
Common Stock, $.001 par value | 15,352,949 |
SPECTRUM PHARMACEUTICALS, INC.
(continued)
March 31, 2005
(Unaudited)
SPECTRUM PHARMACEUTICALS, INC.
TABLE OF CONTENTS
SPECTRUM PHARMACEUTICALS, INC.
FORM 10-Q
For the Three-Month Period Ended March 31, 2005
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
Statement Regarding Financial Information
The condensed consolidated financial statements of Spectrum Pharmaceuticals, Inc. included herein have been prepared by management, without audit, pursuant to the rules and regulations of the Securities and Exchange Commission. Certain information normally included in the consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States has been condensed or omitted pursuant to such rules and regulations. However, we believe that the disclosures are adequate to make the information presented not misleading.
We recommend that you read the 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, 2004, filed with the Securities and Exchange Commission.
3
SPECTRUM PHARMACEUTICALS, INC.
March 31, | December 31, | |||||||
2005 | 2004 | |||||||
(In Thousands, Except Share and Per Share Data) | ||||||||
Assets
|
||||||||
Current Assets:
|
||||||||
Cash and cash equivalents
|
$ | 3,509 | $ | 3,241 | ||||
Marketable securities
|
34,215 | 35,965 | ||||||
Accounts Receivable
|
| 199 | ||||||
Inventory Raw materials
|
332 | 224 | ||||||
Prepaid expenses and other current assets
|
297 | 372 | ||||||
Total current assets
|
38,353 | 40,001 | ||||||
Property and equipment, net
|
641 | 687 | ||||||
Other Assets
|
169 | 70 | ||||||
Total assets
|
$ | 39,163 | $ | 40,758 | ||||
Liabilities and Stockholders Equity
|
||||||||
Current Liabilities:
|
||||||||
Accounts payable
|
$ | 933 | $ | 1,609 | ||||
Accrued compensation
|
216 | 662 | ||||||
Accrued clinical study costs
|
2,186 | 300 | ||||||
Other accrued expenses
|
493 | 95 | ||||||
Total current liabilities
|
3,828 | 2,666 | ||||||
Deferred rent and deposit
|
229 | 178 | ||||||
Total liabilities
|
4,057 | 2,844 | ||||||
Commitments and Contingencies (Note 5)
|
||||||||
Minority Interest
|
22 | 24 | ||||||
Stockholders Equity:
|
||||||||
Preferred Stock, par value $0.001 per share, 5,000,000 shares authorized:
|
||||||||
Series B Junior Participating Preferred Stock, 200,000 shares
authorized, no shares issued and outstanding
|
||||||||
|
||||||||
Series D 8% Cumulative Convertible Voting Preferred Stock, 600 shares
authorized, stated value $10,000 per share, liquidation value $1,884,
issued and outstanding 157 shares at March 31, 2005 and December 31,
2004
|
747 | 747 | ||||||
|
||||||||
Series E Convertible Voting Preferred Stock, 2,000 shares authorized,
stated value $10,000 per share, liquidation value $3,492, issued and
outstanding, 291 shares at March 31, 2005 and December 31, 2004
|
1,795 | 1,795 | ||||||
|
||||||||
Common stock, par value $0.001 per share, 50,000,000 shares authorized:
|
||||||||
Issued and outstanding, 15,352,949 and 14,825,558 shares at March
31, 2005 and December 31, 2004, respectively
|
15 | 15 | ||||||
Additional paid-in capital
|
203,660 | 201,218 | ||||||
Deferred stock-based compensation
|
(77 | ) | (97 | ) | ||||
Accumulated other comprehensive income
|
||||||||
Accumulated deficit
|
(171,056 | ) | (165,788 | ) | ||||
Total stockholders equity
|
35,084 | 37,890 | ||||||
Total liabilities and stockholders equity
|
$ | 39,163 | $ | 40,758 | ||||
The accompanying notes are an integral part of these
condensed consolidated balance sheets.
4
SPECTRUM PHARMACEUTICALS, INC.
Three-Months | Three-Months | |||||||
Ended | Ended | |||||||
March 31, 2005 | March 31, 2004 | |||||||
(In Thousands, Except Share and Per Share Data) | ||||||||
Revenues
|
$ | | $ | | ||||
|
||||||||
Operating expenses:
|
||||||||
Research and development
|
3,694 | 857 | ||||||
General and administrative
|
1,132 | 1,288 | ||||||
Stock-based charges
|
658 | 72 | ||||||
Total operating expenses
|
5,484 | 2,217 | ||||||
|
||||||||
Loss from operations
|
(5,484 | ) | (2,217 | ) | ||||
|
||||||||
Other income, net
|
214 | 49 | ||||||
Net loss before minority interest in consolidated subsidiary
|
(5,270 | ) | (2,168 | ) | ||||
Minority interest in net loss of consolidated subsidiary
|
2 | |||||||
|
||||||||
Net loss
|
$ | (5,268 | ) | $ | (2,168 | ) | ||
|
||||||||
|
||||||||
Basic and diluted net loss per share
|
$ | (0.35 | ) | $ | (0.24 | ) | ||
|
||||||||
Basic and diluted weighted average common shares outstanding
|
15,132,771 | 9,304,042 | ||||||
|
||||||||
Supplemental Information
|
||||||||
Stock-based
charges - Components:
|
||||||||
Research and development
|
$ | 638 | $ | 2 | ||||
General and administrative
|
20 | 70 | ||||||
Total stock based charges
|
$ | 658 | $ | 72 | ||||
The accompanying notes are an integral part of these
condensed consolidated statements.
5
SPECTRUM PHARMACEUTICALS, INC.
Three-Months | Three-Months | |||||||
Ended | Ended | |||||||
March 31, 2005 | March 31, 2004 | |||||||
(In Thousands, Except Share and Per Share Data) | ||||||||
Cash Flows From Operating Activities
:
|
||||||||
Net loss
|
$ | (5,268 | ) | $ | (2,168 | ) | ||
Adjustments to reconcile net loss to net cash used in
operating activities:
|
||||||||
Depreciation and amortization
|
66 | 51 | ||||||
Amortization of deferred stock-based compensation
|
64 | 72 | ||||||
Fair value of common stock issued in connection with drug license
|
594 | | ||||||
Minority interest in subsidiary
|
(2 | ) | ||||||
Changes in operating assets and liabilities:
|
||||||||
Decrease in Accounts Receiveable
|
199 | |||||||
Increase in Inventory
|
(108 | ) | ||||||
Decrease in other current assets
|
75 | 37 | ||||||
Increase (decrease) in accounts payable and accrued expenses
|
1,608 | (623 | ) | |||||
Decrease in accrued compensation and related taxes
|
(446 | ) | (851 | ) | ||||
Increase in other non-current liabilities
|
51 | | ||||||
Net cash used in operating activities
|
(3,167 | ) | (3,482 | ) | ||||
Cash Flows From Investing Activities
:
|
||||||||
Sales of marketable securities
|
1,750 | |||||||
Purchases of marketable securities
|
(99 | ) | (19,999 | ) | ||||
Purchases of property and equipment
|
(20 | ) | (11 | ) | ||||
Net cash provided by (used in) investing activities
|
1,631 | (20,010 | ) | |||||
Cash Flows From Financing Activities
:
|
||||||||
Proceeds from issuance of common stock and warrants, net of
related offering costs and expenses paid during the period
|
750 | 1,399 | ||||||
Proceeds from exercise of warrants
|
1,052 | |||||||
Proceeds from exercise of stock options
|
2 | |||||||
Payments made on capital lease obligations
|
(141 | ) | ||||||
Minority investment in subsidiary
|
20 | |||||||
Net cash provided by financing activities
|
1,804 | 1,278 | ||||||
Net increase (decrease) in cash and cash equivalents
|
268 | (22,214 | ) | |||||
Cash and cash equivalents, beginning of period
|
3,241 | 24,581 | ||||||
Cash and cash equivalents, end of period
|
$ | 3,509 | $ | 2,367 | ||||
Supplemental Cash Flow Information
:
|
||||||||
Interest paid
|
$ | | $ | 2 | ||||
Income taxes paid
|
$ | 1 | $ | 1 | ||||
Schedule of Non-Cash Investing and Financing Activities
:
|
||||||||
Fair value of common stock issued in connection with drug license
|
$ | 594 | ||||||
Preferred stock dividends paid with common stock
|
$ | 31 | $ | 54 | ||||
Fair value of warrants issued to consultants for services
|
$ | 44 | $ | 157 | ||||
The accompanying notes are an integral part of these
condensed consolidated statements.
6
SPECTRUM PHARMACEUTICALS, INC.
March 31, 2005
(Unaudited)
1. Business and Basis of Presentation
Business
Spectrum Pharmaceuticals, Inc. (the Company) is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for various indications. While we own patent rights to certain product candidates, the drug products we are currently developing, which are focused on the treatment of cancer and other unmet medical needs, are in-licensed from third parties whereby we acquired exclusive rights to develop and commercialize those compounds in territories specified in the agreements. We are also actively seeking FDA approval for marketing generic versions of branded drugs whose patent protection has either already expired, or is scheduled to expire in the foreseeable future.
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements are prepared on a consistent basis in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring accruals and consolidation and elimination entries) considered necessary for a fair presentation have been included. Operating results for the three-month period ended March 31, 2005 are not necessarily indicative of the results that may be expected for the year ending December 31, 2005. The balance sheet at December 31, 2004 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, 2004.
Certain quarterly amounts have been reclassified to conform to the current period presentation.
2. Summary of Significant Accounting Policies and Estimates
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and of our wholly owned and majority owned subsidiaries. As of March 31, 2005, we had three subsidiaries: NeoJB LLC (NeoJB), 80% owned, organized in Delaware in April 2002; Spectrum Pharmaceuticals GmbH, wholly owned, incorporated in Switzerland in April 1997; and NeoGene Technologies, Inc. (NeoGene), an inactive subsidiary, 88.4% owned, incorporated in California in October 1999. 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.
Since the adoption of our current business strategy in August 2002, we have operated in one business segment, that of acquiring, developing and commercializing prescription drug products. The business has not matured to the point that disaggregated segment information would be meaningful. Accordingly, the accompanying financial statements are reported in the aggregate including all our activities in one segment.
Certain prior year amounts have been reclassified to conform to the current year presentation.
7
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
Use of Estimates |
The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires us to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent obligations in the financial statements and accompanying notes. Our most significant assumptions are employed in estimates used in determining values of financial instruments and accrued obligations, as well as in estimates used in applying the revenue recognition policy and estimating stock-based charges. The estimation process requires assumptions to be made about future events and conditions, and as such, is inherently subjective and uncertain. Actual results could differ materially from our estimates.
Fair Value of Financial Instruments
The carrying amounts of cash and cash equivalents, marketable securities, accounts receivable, accounts payable and accrued liabilities, as reported in the balance sheets, are considered to approximate fair value given the short term maturity and/or liquidity of these financial instruments.
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities primarily consist of corporate debt and equity and municipal obligations, including market auction debt securities, but also include government agency notes, certificates of deposit, bank checking and time deposits, and institutional money market funds. 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 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, Supplier and Customer
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 by the fact that we invest only in investment grade securities. We have not incurred any significant credit risk losses related to such investments.
As of March 31, 2005, we had a bank account with a balance that exceeded the amount insured by the Federal Deposit Insurance Corporation by $492,000. We believe this concentration risk is mitigated by the financial strength of the bank at which we maintain the account.
Inventory
Inventory is stated at the lower of cost (first-in, first-out method) or market. As of March 31, 2005, inventory consisted of raw materials acquired for the purpose of manufacturing finished drug product for our drug product candidate carboplatin.
8
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
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
License fees representing non-refundable payments received upon the execution of license agreements are recognized as revenue upon execution of the license agreements where we have no significant future performance obligations and collectibility of the fees is assured. Milestone payments, which are generally based on developmental or regulatory events, are recognized as revenue when the milestones are achieved, collectibility is assured, and we have no significant future performance obligations in connection with the milestones. In those instances where we have collected fees or milestone payments but have ongoing future obligations related to the development of the drug product, revenue recognition is deferred and amortized ratably 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. 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.
Basic and Diluted Net Loss Per Share
In accordance with FASB Statement No. 128, Earnings Per Share , we calculate basic and diluted net loss per share using the weighted average number of common shares outstanding during the periods presented, and adjust the amount of net loss, used in this calculation, for preferred stock dividends declared during the period.
We incurred a net loss in each period presented, and as such, did not include the effect of potentially dilutive common stock equivalents in the diluted net loss per share calculation, as their effect would be anti-dilutive for all periods. Potentially dilutive common stock equivalents would include the common stock issuable upon the conversion of preferred stock and the exercise of warrants and stock options that have conversion or exercise prices below the market value of our common stock at the measurement date. As of March 31, 2005 and 2004, such potentially dilutive common stock equivalents amounted to approximately 11 million and 9 million shares, respectively.
9
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
The following data show the amounts used in computing basic loss per share for the three-month periods ended March 31, 2005 and 2004.
Three-Months | Three-Months | |||||||
Ended | Ended | |||||||
March 31, 2005 | March 31, 2004 | |||||||
(In Thousands, Except Share and Per Share Data) | ||||||||
Net loss
|
$ | (5,268 | ) | $ | (2,168 | ) | ||
Less:
|
||||||||
Preferred dividends paid in cash or stock
|
(31 | ) | (54 | ) | ||||
Income available to common stockholders
used in computing basic earnings per
share
|
$ | (5,299 | ) | $ | (2,222 | ) | ||
|
||||||||
|
||||||||
Weighted average shares outstanding
|
15,132,771 | 9,304,042 | ||||||
|
||||||||
|
||||||||
Basic and diluted net loss per share
|
$ | (0.35 | ) | $ | (0.24 | ) | ||
|
Accounting for Stock-Based Employee Compensation
At March 31, 2005, we had three stock-based employee compensation plans, which are described more fully in Note 9 to the Financial Statements included in our Annual Report on Form 10-K for the year ended December 31, 2004. As permitted by FASB Statement No. 123, Accounting for Stock-Based Compensation , we account for grants pursuant to those plans under the intrinsic value method described in Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees , and related Interpretations. Under the intrinsic value method, no stock-based employee compensation cost is recorded when the exercise price is equal to, or higher than, the market value of the underlying common stock on the date of grant. We recognize stock-based compensation expense for all grants to consultants and for those grants to employees where the exercise prices are below the market price of the underlying stock at the measurement date of the grant.
The following table illustrates the effect on net loss and loss per share if we had applied
the fair value recognition provisions of FASB Statement No. 123,
Accounting for Stock-Based
Compensation
, to stock-based employee compensation, using the straight-line method, for the
three-month periods ended March 31, 2005 and 2004.
Three-Months
Three-Months
Ended
Ended
March 31, 2005
March 31, 2004
(In Thousands, Except Share and Per Share Data)
$
(5,268
)
$
(2,168
)
(1,982
)
(409
)
$
(7,250
)
$
(2,577
)
$
(0.35
)
$
(0.24
)
$
(0.48
)
$
(0.28
)
10
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
Comprehensive Loss
The net loss reflected on our Consolidated Statements of Operations substantially represents the total comprehensive loss for the periods presented.
New Accounting Pronouncements
In December 2004, the FASB issued Statement No. 123(R), Share-Based Payment. This Statement eliminates the use of the intrinsic value method described in Accounting Principles Board (APB) Opinion No. 25, Accounting for Stock Issued to Employees , and requires an entity to measure the cost of employee services received in exchange for an award of equity instruments based on the grant-date fair value of the award. That cost will be recognized over the period during which an employee is required to provide service in exchange for the award. We expect to adopt the provisions of Statement No. 123(R) when it becomes a mandatory requirement, currently expected to be January 1, 2006. The adoption of this Statement is expected to result in significantly higher reported operating expenses in our future financial statements. Had we adopted the provisions of Statement No. 123(R) as of January 1, 2005, our reported loss for the three-month period ended March 31, 2005 would have been approximately $1,982,000 higher, or $7,250,000, as disclosed above in this Note 2, Accounting for Stock-Based Employee Compensation.
3. Products and Strategic Alliances
As of March 31, 2005, we had six proprietary drug product candidates under development: satraplatin, EOquin, elsamitrucin, SPI-153; RenaZorb; and SPI-1620, and through the date of this report have filed ten ANDAs with the FDA, including that for ciprofloxacin, which was approved in September 2004. We are developing our proprietary drug product candidates for the treatment of a variety of cancers and other unmet medical needs. We are also active in filing ANDAs with the FDA seeking approval for marketing generic versions of branded prescription drugs whose patent protection has either already expired, or is scheduled to expire in the foreseeable future. In addition, we have a few neurology compounds that we may out-license to third parties for further development.
In general, we direct and pay for all aspects of the drug development process, and consequently incur the risks and rewards of drug development, which is an inherently uncertain process. To mitigate such risks we enter into alliances where we believe that our partners can provide strategic advantage in the development, manufacturing or distribution of our drugs. In such situations, the alliance partners may share in the risks and rewards of the drug development and commercialization.
Business Alliances
Our business alliances are described in detail in our Annual Report on Form 10-K for the year ended December 31, 2004. The following represents an update for current developments.
Cura Pharmaceuticals Co., Inc (CURA ): In April 2005, we entered into an exclusive agreement with Cura Pharmaceuticals Co. Inc. for the marketing and distribution of carboplatin injection in the United States, currently awaiting approval from the FDA. With this alliance now in place, we should be able to launch our product shortly after receiving final approval from the FDA, which we currently anticipate will occur in 2005.
Products under development
The following is a brief outline of the products under development as of March 31, 2005:
11
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
Satraplatin : Satraplatin is an orally-administered chemotherapeutic agent that has an initial indication of efficacy in treating hormone refractory prostate cancer. As of March 31, 2005, a Phase 3 clinical trial was proceeding in accordance with plans.
EOquin : EOquin (EO-9), a synthetic prodrug (an inactive drug compound) which is activated by certain enzymes present in higher amounts in cancer cells than in normal tissues, is currently being developed for its initial indication, refractory superficial bladder cancer. As of March 31, 2005, a Phase 2 clinical trial had been completed and results were being monitored. In addition, EO-9 is being evaluated as a radiation sensitizer.
Elsamitrucin : Elsamitrucin, an anti-tumor antibiotic that acts as a dual inhibitor of two key enzymes involved in DNA replication, topoisomerase I and II, is currently being developed for its initial indication, refractory non-Hodgkins lymphoma. As of March 31, 2005, a Phase 2 clinical trial was proceeding in accordance with plans.
SPI-153 : SPI-153, a fourth generation LHRH (Luteinizing Hormone Releasing Hormone, also known as GnRH or Gonadotropin Releasing Hormone) antagonist is under evaluation for its initial indications, hormone-dependent prostate cancer, and benign prostatic hypertrophy. As of the date of this report, Phase 2 clinical trials had been initiated in each of those indications.
RenaZorb: In January 2005, we entered into a license agreement with Altair Nanotechnologies, Inc., whereby we acquired an exclusive worldwide license to develop and commercialize, for all human therapeutic and diagnostic uses, RenaZorb. These are two second-generation lanthanum-based phosphate binding agents which utilize Altairs proprietary lanthanum nanoparticle technology and have the potential to treat hyperphosphatemia, or high phosphate levels in blood, in patients with end-stage and chronic kidney disease. We paid Altair an upfront payment of 100,000 shares of restricted Spectrum common stock and $200,000 in cash, and received 38,314 shares of Altair common stock, which we recorded as a long-term investment at $104,000, the fair value of the stock on the date the transaction was consummated. We are obligated to make future payments contingent upon the successful achievement of development and regulatory milestones specified in the agreement, and, in addition, are obligated to pay royalties and milestone payments based on net sales, if any, after marketing approval is obtained from regulatory authorities. Upon successful achievement of one of the development milestones, which is anticipated to occur in 2005, we will be obligated to issue 100,000 restricted shares of our common stock to Altair.
SPI-1620 : In February 2005, we entered into a license agreement with Chicago Labs, Inc., whereby we acquired an exclusive worldwide license to develop and commercialize SPI-1620, an endothelinB agonist, which we believe may selectively dilate tumor blood vessels and thereby selectively increase the delivery of anti-cancer drugs to cancer tissue, for the prevention and treatment of cancer. We paid Chicago Labs an upfront fee of $100,000 in cash, and are obligated to make future payments contingent upon the successful achievement of development and regulatory milestones specified in the agreement. In addition, we are obligated to pay royalties and milestone payments based on net sales, if any, after marketing approval is obtained from regulatory authorities.
4. Marketable Securities
Held-to-maturity marketable securities, $15,000 as of March 31, 2005, are carried at cost, which approximates fair value because of their short-term maturities and insignificant interest rate risk. Available-for-sale marketable securities, $34.2 million as of March 31, 2005, are carried at fair value, with any unrealized gains and losses included as a component of accumulated other comprehensive income (loss) in stockholders equity.
Realized gains and losses and declines in value judged to be other-than-temporary on available-for-sale securities, as well as interest income and dividends on investments, are included in other income and expense. Unrealized and realized gains or losses were not significant as of March 31, 2005, or for the three-month periods ended March 31, 2005 and 2004.
12
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
As of March 31, 2005, the maturities of our available for sale securities, primarily composed of 28-day auction rate notes, was in excess of 10 years. These securities are classified as current assets based on our intent and ability to use any and all of these securities as necessary to satisfy our cash needs as they arise, by redeeming them at par within a 28-day period.
5. Commitments and Contingencies
Facility and Equipment Leases
As of March 31, 2005 we were obligated under a facility lease and several operating equipment leases. We have sub-leased a portion of our facility through September 2007, with a renewal option through the remaining term of our underlying lease.
Minimum lease commitments, and minimum contractual sublease income 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
Sub-Lease Commitments
Amounts In Thousands
$
310
$
162
$
451
$
225
$
471
$
171
$
491
$
$
250
$
$
3
$
$
1,976
$
558
Licensing Agreements
Each of our proprietary drug product candidates is being developed pursuant to license agreements, which provide us with exclusive rights to certain territories to, among other things, develop, sublicense, and sell the drug product candidates. With regard to one of our drug product candidates, satraplatin, we have outlicensed our rights to GPC Biotech AG. We are required to use commercially reasonable efforts to develop the drug product candidates, are generally responsible for all development, patent filing and maintenance costs, sales, marketing and liability insurance costs, and are 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 milestone payments based on net sales, if any, after marketing approval is obtained from regulatory authorities. We have no similar milestone or other payment obligations in connection with our generic drug products.
The potential contingent milestone obligations, aggregating approximately $45 million as of March 31, 2005, 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: commencement of Phase 3 clinical trials, filing of new drug applications in the United States, Europe and Japan, and approvals from those regulatory agencies.
Given the unpredictability of the drug development process, we are unable to predict when any of the milestones will occur and, accordingly, the milestone payments represent contingent obligations, which will be recorded as expense when the milestone is achieved.
13
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
If we reach a milestone, it will likely occur prior to revenues being generated from the related compound. However, in connection with the milestone obligations related to satraplatin, each of our contingent future payment obligations is generally matched by a corresponding, greater payment milestone obligation of GPC Biotech to us.
Service Agreements
In connection with the research and development of our drug products, we have entered into contracts with numerous third-party service providers, such as clinical trial centers, clinical research organizations, data monitoring centers, and with drug formulation, development and testing laboratories. The financial terms of these agreements are varied and generally obligate us to pay in stages, depending on achievement of certain events specified in the agreements, such as contract execution, reservation of service or production capacity, actual performance of service, or the successful accrual and dosing of patients. As of each period end, we accrue for all non-cancelable installment amounts that we are likely to become obligated to pay.
Employment Agreements
We have entered into employment agreements with two of our Executive Officers, Dr. Shrotriya, Chief Executive Officer, and Dr. Lenaz, Chief Scientific Officer, expiring December 31, 2005 and July 1, 2006, respectively. The employment agreements automatically renew for a one-year term unless either party gives written notice at least 90 days prior to the commencement of the next year of such partys intent not to renew the agreement. The agreements require each executive to devote his full working time and effort to the business and affairs of the Company during the term of the agreement. The agreements provide for an annual base salary with annual increases, periodic bonuses and option grants as determined by the Compensation Committee of our Board of Directors.
Each officers employment may be terminated by us with or without cause, as defined in the agreement. The agreements provide for certain guaranteed severance payments and benefits if the officers employment is terminated without cause, if the officers employment is terminated due to a change in control or is adversely affected due to a change in control and the officer resigns or if the officer decides to terminate his employment due to a disposition of a significant amount of assets or business units. The guaranteed severance payment includes a payment equal to the officers annual base salary and other cash compensation, and any approved bonus. The officer is also entitled to two years medical, dental and other benefits for two years following termination. In addition, all options held by the officer shall immediately vest and will be exercisable for one year from the date of termination; provided, however, if the Board determines that the officers employment is being terminated for the reason that the shared expectations of the officer and the Board are not being met, in the Boards judgment, then the options currently held by the officer will vest in accordance with their terms for up to one year after the date of termination, with the right to exercise those options, when they vest, for approximately thirteen (13) months after the date of termination. The agreements also provide that, upon his retirement, all options held by the officer will become fully vested.
Litigation
On February 18, 2005, GlaxoSmithKline filed a lawsuit against us in the United States District Court for the District of Delaware, alleging infringement of the patent on Imitrex®. This lawsuit was filed as a result of an ANDA that we filed with the FDA in October 2004 for sumatriptan succinate injection 6mg/0.5mL, seeking approval to engage in the commercial manufacture, sale, and use of the sumatriptan succinate injection product in the United States. Sumatriptan succinate is marketed by GlaxoSmithKline under the brand name Imitrex® and is used for the acute treatment of migraine attacks with or without aura and the acute treatment of cluster headache episodes in adults. Our ANDA includes a Paragraph IV certification that the existing patent associated with GlaxoSmithKlines Imitrex® injection, is invalid, unenforceable and/or will not be infringed by our generic product candidate. While it is not possible to determine with any degree of certainty the ultimate outcome of these legal proceedings, we believe that we have substantial and meritorious basis with respect to our Paragraph IV challenge of the GlaxoSmithKline patent for sumatriptan succinate injection 6mg/0.5mL.
14
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
(Unaudited)
6. Stockholders Equity
Common Stock
In connection with the license agreement with Altair Nanotechnologies, Inc., on January 28, 2005, we issued 100,000 restricted shares of Spectrum common stock to Altair. The fair value of the stock, $594,000, was recorded as a stock-based charge for the three-month period ended March 31, 2005.
In connection with the FDA approval of the ciprofloxacin ANDA in September 2004, an entity affiliated with J.B. Chemical & Pharmaceuticals Ltd., our joint venture partner for ciprofloxacin, invested $750,000 in February 2005. We issued 119,617 restricted shares of common stock to that entity, based on the closing price of our common stock on the day prior to the FDA approval.
Deferred Stock-Based Compensation
During the three-month period ended March 31, 2005, we granted 957,652 stock options to employees and a consultant at exercise prices equal to or greater than the quoted price of our common stock on the grant dates. The fair value of the stock options to the consultant was estimated at approximately $110,000, using the Black-Scholes option pricing model with the following assumptions: dividend yield of 0%; expected volatility of 91.6%; risk free interest rate of 3.7%; and an expected life of five years, was recorded as deferred compensation, and is being amortized to expense over the vesting period of the option.
During the three-month periods ended March 31, 2005 and 2004, amortization of deferred
stock-based compensation amounted to $64,000 and $72,000, respectively.
Warrants Activity
We typically issue warrants to purchase shares of our common stock to investors as part of a
financing transaction, or in connection with services rendered by placement agents and outside
consultants. Our outstanding warrants expire at varying dates through April 2009. Below is a
summary of warrant activity during the three-month period ended March 31, 2005:
Common Stock
Weighted Average Exercise
Warrants
Price
6,561,789
$
9.71
$
(300,963
)
$
(3.50
)
$
(5,760
)
$
(483.33
)
6,255,066
$
9.57
5,003,061
$
9.46
15
SPECTRUM PHARMACEUTICALS, INC.
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2005
Stock Incentive Plans Activity
Below is a summary of activity, for all of our stock incentive plans, during the three-month
period ended March 31, 2005:
(Unaudited)
Weighted
Common
Average
Stock
Exercise
Options
Price
2,370,026
$
7.97
957,652
$
6.66
(2,000
)
$
1.06
0
$
0
$
3,325,678
$
7.60
1,766,325
$
8.35
As of March 31, 2005, approximately 1.2 million incentive awards were available for grant under all of our stock incentive plans.
We apply APB Opinion No. 25 and related interpretations in accounting for stock options
granted to employees and directors, and do not recognize compensation expense when the exercise
price of the options equals the fair market value of the underlying shares at the date of grant.
All of the options granted during the three-month period ended March 31, 2005 were made at fair
market values on the dates authorized by the Board of Directors or the Compensation Committee, as
applicable.
Common Stock Reserved for Future Issuance
As of March 31, 2005, approximately 11 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:
16
665,691
582,000
3,325,678
6,255,066
10,828,435
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 words, not limited to, believes, may,
will, expects, intends, estimates, anticipates, plans, seeks, or continues, that
are 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, and in reliance upon
the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. 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 Risk Factors. These factors include, but are not limited to:
You should read the following discussion of the financial condition and results of our
operations in conjunction with the condensed financial statements and the notes to those financial
statements included in Item 1 of Part 1 of this report.
Overview
Spectrum Pharmaceuticals, Inc. is a specialty pharmaceutical company engaged in the business
of acquiring, developing and commercializing prescription drug products for various indications.
While we own patent rights to certain product candidates, the drug products we are currently
developing, which are focused on the treatment of cancer and other unmet medical needs, are
in-licensed from third parties whereby we acquired exclusive rights to develop and commercialize
those compounds in territories specified in the agreements. We are also actively seeking FDA approval for marketing
generic versions of branded drugs whose patent protection has either already expired, or is
scheduled to expire in the foreseeable future. In September 2004, the FDA granted us approval to
market, in the United States, ciprofloxacin, the generic version of the anti-bacterial drug Cipro®,
which is marketed by Bayer.
New drug development is an inherently uncertain, lengthy and expensive process. We focus our
research and development efforts principally on clinical stage drug candidates, for which the
primary expenses relate to the conduct of clinical trials necessary to demonstrate to the
satisfaction of the U.S. Food and Drug Administration, or FDA, and other regulatory authorities in
the United States and other countries, that the products are both safe and effective in their
respective indications and that they can be produced by a validated consistent manufacturing
process. The number, size, scope and timing of the clinical trials necessary to bring a product
candidate to development completion and commercialization cannot readily be determined at an early
stage, nor, given the timelines of the trials extending over periods of years, can future costs be
estimated with precision. While generic drug development is also subject to approval by regulatory
authorities, the costs and timelines of development completion and commercialization can be
significantly shorter, and compared to new drug development, relatively less uncertain and less
expensive.
17
Business Outlook
Our primary business focus for 2005, and beyond, will be to continue to acquire and develop a
portfolio of marketable prescription drug products with a mix of near-term and long-term revenue
potential.
As of the date of filing this report, we had six proprietary drug product candidates under
development: satraplatin, EOquin, elsamitrucin, SPI-153; RenaZorb; and SPI-1620, and through that
date had filed ten ANDAs with the FDA, including that for ciprofloxacin, which was approved in
September 2004.
Our goal is to continue to acquire or license additional promising drug product candidates for
clinical stage development, and to pursue additional ANDA filings, including several injectable
products, and to have several generic drugs FDA approved and marketed in the U.S. over the next 5
years. In this regard we are evaluating several general drug candidates for feasibility. The
evaluation of feasibility includes many factors, including, but not limited to, evaluation of
market potential, competition, potential patent extensions, and availability of active
pharmaceutical ingredients and manufacturing capacity.
Financial Condition
Liquidity and Capital Resources
Our current business operations do not generate sufficient operating cash to finance the
clinical development of our drug product candidates. Our cumulative losses, since inception in
1987, through March 31, 2005, have exceeded $170 million. We expect to continue to incur
significant additional losses as we implement our growth strategy of developing marketable drug
products for at least the next several years unless they are offset, if at all, by licensing
revenues under our out-license agreement with GPC Biotech AG and any profits from the sale of
generic products.
We believe that the approximately $38 million in cash, cash equivalents and marketable
securities that we had on hand as of March 31, 2005, will allow us to fund our current planned
operations for at least the next twelve months. While anticipated profits from the sale of generic
drugs, if we are successful in generating revenues from generics, may help defray some of the
expenses of operating our business, we believe that in order to prepare the company for future drug
product acquisition and development, and to capitalize on growth opportunities, we will, for the
foreseeable future, need to continue to raise funds through public or private financings. Our
operations have historically been financed by the issuance of capital stock because it is generally
difficult to fund pharmaceutical research and development via borrowings due to the significant
expenses involved, lack of revenues sufficient to service debt and the significant inherent
uncertainty as to results of research and the timing of those results.
As described elsewhere in this report, including the Risk Factors section, our drug
development efforts are subject to the considerable uncertainty inherent in any new drug
development. Due to the uncertainties involved in progressing through clinical trials, and the time
and cost involved in obtaining regulatory approval and in establishing collaborative arrangements,
among other factors, we cannot reasonably estimate the timing and ultimate aggregate cost of
developing each of our drug product candidates, and are similarly unable to reasonably estimate
when, if ever, we will realize material net cash inflows from our proprietary drug product
candidates. Accordingly,
18
the following discussion of our current assessment of the need for cash to fund our operations
for at least the next twelve months may prove too optimistic and our assessment of expenditures may
prove inadequate.
Over the past two years, since the inception of our current business strategy in August 2002,
our expenditures for research and development and general and administrative expenses, excluding
license acquisition costs, have been largely incurred on non-product-specific, or indirect, costs
such as personnel, occupancy and other fixed costs representing approximately 80% of total
expenditures. We anticipate that over the next twelve months, such indirect costs will range
between approximately $8 million and $9 million. In addition, we incur product-specific development
costs such as upfront license fees, milestone payments, active pharmaceutical ingredient (API),
clinical trials, patent search legal costs, and product liability insurance, among others. The
following describes our current assessment of product specific development costs for each
significant proprietary product, and generics as a group, currently under development. As we
mentioned above, these costs are subject to uncertainties inherent in new drug development. In
addition, the expenses are not necessarily cumulative. We may reduce the amount we spend on one
product to shift our cash resources to another product. Therefore, what we actually spend to
develop a particular product may not fall within the estimated range and the estimated ranges may
change from quarter to quarter based upon changes in priorities or strategy and/or the results of
the development. While we do not receive any funding from third parties for research and
development we conduct, our estimated costs could be mitigated should we enter into co- development
agreements for any of our drug product candidates.
19
Marketing of ciprofloxacin tablets, our first generic drug, commenced in the fourth quarter of
2004. Fifteen other companies have received FDA approval to market generic versions of
ciprofloxacin tablets, and we have observed a significant reduction in the market price for
ciprofloxacin tablets since June 2004, when the pediatric exclusivity for ciprofloxacin expired. We
expect to receive approval by the FDA of our ANDAs for carboplatin injection and fluconazole
tablets in 2005. The marketing exclusivity for Bristol Myers Squibbs branded form of carboplatin
injection expired in October 2004, and the FDA has granted ANDA approval to five generic companies,
including Pharmachemie, APP, Bedford, Mayne and Pliva. TEVA Pharmaceuticals, through an agreement
with Bristol Myers Squibb, is currently selling carboplatin injection produced by Bristol Myers
Squibb as a generic drug. The marketing exclusivity for Pfizers branded form of fluconazole
tablets expired in July 2004, and the FDA has approved generic versions from several companies,
including Taro Pharmaceutical Industries, Mylan, Sandoz, Ranbaxy, IVAX, Genpharm, Gedeon Richter,
TEVA, Torpharm, Roxane and Pliva. We have observed significant price declines in the marketplace
for each of the foregoing products. Accordingly, given the competition faced by these products and
the fact that we are still seeking alliances with third parties to assist us in the marketing and
sale of flucanazole tablets and carboplatin injection, we are unable at this time to reasonably
estimate potential revenues or profits from these generic products in the foreseeable future.
Net Cash used in Operating activities
During the three month period ended March 31, 2005, the net cash used in operations,
approximately $3.2 million, was less than the approximately $4.8 million expenditures for research
and development and general and administrative expenses incurred during the quarter, because
accrued expenses increased by approximately $1.6 million during the three-month period ended March
31, 2005.
Based
on our current plans, our anticipated use of cash for operations for the remainder of 2005, excluding the cost of
in-licensing any additional drug products, is expected to average approximately $5 million per
quarter, reflecting the increase in the scope of our activities.
Net Cash used for Investing Activities
In order to maximize the interest yield on our investments, we invest our cash in a variety of
investments pending its use in our business. During the three-month period ended March 31, 2005,
we used $1.75 million of invested funds for operating cash needs. We also paid Altair $200,000 in
cash in connection with the in-licensing of Renazorb. The fair value of Altair stock received,
approximately $104,000, was recorded as a long term investment and the remaining amount of $96,000
was charged as research and development expense for the three-month period ended March 31, 2005.
Net Cash provided by and used for Financing Activities
Net cash provided by financing activities, approximately $1.8 million, for the three-month
period ended March 31, 2005, was comprised of $1.1 million from the exercise of outstanding
warrants for 300,963 shares of our common, from the exercise of stock options for 2,000 shares of
our common stock, and $750,000 received as an equity investment for the issuance of 119,617
restricted shares of our common stock.
20
Results of Operations
Results of Operations for the three-month period ended March 31, 2005 Compared to the three-month
period ended March 31, 2004
For the three-months ended March 31, 2005, we incurred a net loss of approximately $5.3
million compared to a net loss of approximately $2.2 million in the three-months ended March 31,
2004. The increase of $3.1 million in the net loss was primarily due to an increase of
approximately $2.8 million in research and development expense, and an increase of approximately
$586,000 in stock-based charges related to the acquisition of RenaZorb.
We had no revenues during the three-month periods ended March 31, 2005 and 2004.
Research and development expenses increased by approximately $2.8 million, from $0.9 million
in the three months ended March 31, 2004 to $3.7 million in the three months ended March 31, 2005,
primarily due to an increase of approximately $2.3 million resulting from an expansion in the
number and scope of our clinical trials activity, and an increase of approximately $0.3 million in
research and development personnel costs. During the three-month period ended March 31, 2004, the
principal clinical trials costs related to a Phase 2 trial on
EOquin. In the three-month period
ended March 31, 2005, we incurred costs related to Phase 2 clinical trials on EOquin, elsamitrucin
and SPI-153, as described elsewhere in this report.
General and administrative expenses decreased by approximately $0.2 million, from $1.3 million
in the three months ended March 31, 2004 to $1.1 million in the three months ended March 31, 2005,
primarily due to a reduction of approximately $0.2 million in legal fees.
Stock-based charges increased by approximately $586,000, from $72,000 in the three months
ended March 31, 2004 to $658,000 in the three months ended March 31, 2005, resulting from recording
the estimated fair value of 100,000 shares of common stock issued to Altair Nanotechnologies, Inc.
in connection with the in-licensing of RenaZorb.
Other income consisted of net interest income of $214,000 for the three-month period ended
March 31, 2005 and $49,000 for the three-month period ended March 31, 2004. The increase of
$165,000 is attributable to significantly higher average interest rates and balances of investable
funds in 2005.
Off-Balance Sheet Arrangements
None.
Contractual and Commercial Obligations
The following table summarizes our contractual and other commitments, including obligations
under facility and equipment leases, as of March 31, 2005:
Payment Due by Period
21
Licensing Agreements
Each of our proprietary drug product candidates is being developed pursuant to license
agreements, which provide us with exclusive rights to certain territories to, among other things,
develop, sublicense, and sell the drug product candidates. With regard to one of our drug product
candidates, satraplatin, we have outlicensed our rights to GPC Biotech AG. We are required to use
commercially reasonable efforts to develop the drug product candidates, are generally responsible
for all development, patent filing and maintenance costs, sales, marketing and liability insurance
costs, and are 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 milestone payments based on net sales, if any, after
marketing approval is obtained from regulatory authorities. We have no similar milestone or other
payment obligations in connection with our generic drug products.
The potential contingent milestone obligations, aggregating approximately $45 million as of
March 31, 2005, 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: commencement of Phase 3 clinical trials, filing of
new drug applications in the United States, Europe and Japan, and approvals from those regulatory
agencies.
Given the unpredictability of the drug development process, we are unable to predict when any
of the milestones will occur and, accordingly, the milestone payments represent contingent
obligations, which will be recorded as expense when the milestone is achieved.
If we reach a milestone, it will likely occur prior to revenues being generated from the
related compound. However, in connection with the milestone obligations related to satraplatin,
each of our contingent future payment obligations is generally matched by a corresponding, greater
payment milestone obligation of GPC Biotech to us.
Service Agreements
In connection with the research and development of our drug products, we have entered into
contracts with numerous third-party service providers, such as clinical trial centers, clinical
research organizations, data monitoring centers, and with drug formulation, development and testing
laboratories. The financial terms of these agreements are varied and generally obligate us to pay
in stages, depending on achievement of certain events specified in the agreements, such as contract
execution, reservation of service or production capacity, actual performance of service, or the
successful accrual and dosing of patients. As of each period end, we accrue for all non-cancelable
installment amounts that we are likely to become obligated to pay, and charge such accruals to
research and development costs.
22
Employment Agreements
We have entered into employment agreements with two of our Executive Officers, Dr. Shrotriya,
Chief Executive Officer, and Dr. Lenaz, Chief Scientific Officer, expiring December 31, 2005 and
July 1, 2006, respectively. The employment agreements automatically renew for a one-year term
unless either party gives written notice at least 90 days prior to the commencement of the next
year of such partys intent not to renew the agreement. The agreements require each executive to
devote his full working time and effort to the business and affairs of the Company during the term
of the agreement. The agreements provide for an annual base salary with annual increases, periodic
bonuses and option grants as determined by the Compensation Committee of our Board of Directors.
Each officers employment may be terminated by us with or without cause, as defined in the
agreement. The agreements provide for certain guaranteed severance payments and benefits if the
officers employment is terminated without cause, if the officers employment is terminated due to
a change in control or is adversely affected due to a change in control and the officer resigns or
if the officer decides to terminate his employment due to a disposition of a significant amount of
assets or business units. The guaranteed severance payment includes a payment equal to the
officers annual base salary and other cash compensation, and any approved bonus. The officer is
also entitled to two years medical, dental and other benefits for two years following termination.
In addition, all options held by the officer shall immediately vest and will be exercisable for one
year from the date of termination; provided, however, if the Board determines that the officers
employment is being terminated for the reason that the shared expectations of the officer and the
Board are not being met, in the Boards judgment, then the options currently held by the officer
will vest in accordance with their terms for up to one year after the date of termination, with the
right to exercise those options, when they vest, for approximately thirteen (13) months after the
date of termination. The agreements also provide that, upon his retirement, all options held by the
officer will become fully vested.
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. On
an on-going basis, we evaluate our estimates, including cash requirements, from 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.
Use of Estimates
The preparation of financial statements in conformity with accounting principles generally
accepted in the United States requires us to make estimates and assumptions that affect the
reported amounts of assets, liabilities, revenues and expenses and disclosure of contingent
obligations in the financial statements and accompanying notes. Our most significant assumptions
are employed in estimates used in estimating stock-based charges, determining values of financial
instruments and accrued obligations, as well as in estimates used in applying the revenue
recognition policy. 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.
In estimating the fair value of stock-based compensation, we use the Black Scholes Option
Pricing Model. We estimate future volatility based on past volatility of our common stock; and we
estimate the expected length of the option on several criteria, including the vesting period of the
grant, and the expected volatility. In estimating the fair value of restricted common stock we
issue in connection with licensing transactions, we apply a discount for the marketability
restrictions, that is calculated after considering past volatility of our common stock as well as
the term of restriction and the cost of risk free capital for a period that is comparable with the term
of the restriction on the shares.
23
Cash, Cash Equivalents and Marketable Securities
Cash, cash equivalents and marketable securities primarily consist of corporate debt and
equity and municipal obligations, including market auction debt securities, but also include
government agency notes, certificates of deposit, bank checking and time deposits, and
institutional money market funds. 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 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
License fees representing non-refundable payments received upon the execution of license
agreements are recognized as revenue upon execution of the license agreements where we have no
significant future performance obligations and collectibility of the fees is assured. Milestone
payments, which are generally based on developmental or regulatory events, are recognized as
revenue when the milestones are achieved, collectibility is assured, and we have no significant
future performance obligations in connection with the milestones. In those instances where we have
collected fees or milestone payments but have ongoing future obligations related to the development
of the drug product, revenue recognition is deferred and amortized ratably 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. 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.
Accounting for Stock-Based Employee Compensation
At March 31, 2005, we had three stock-based employee compensation plans, which are described
more fully in Note 9 to the Financial Statements included in our Annual Report on Form 10-K for the
year ended December 31, 2004. As permitted by FASB Statement No. 123,
Accounting for Stock-Based
Compensation
, we account for grants pursuant to those plans under the intrinsic value method
described in Accounting Principles Board (APB) Opinion No. 25,
Accounting for Stock Issued to
Employees
, and related Interpretations. Under the intrinsic value method, no stock-based employee
compensation cost is recorded when the exercise price is equal to, or higher than, the market value
of the underlying common stock on the date of grant. We recognize stock-based compensation expense
for all grants to consultants, and for those grants to employees where the exercise prices are
below the market price of the underlying stock at the measurement date of the grant.
24
New Accounting Pronouncements
In
December 2004, the FASB issued Statement No. 123(R),
Share-Based Payment
. This Statement
eliminates the use of the intrinsic value method described in Accounting Principles Board (APB)
Opinion No. 25,
Accounting for Stock Issued to Employees
, and requires a public entity to measure
the cost of employee services received in exchange for an award of equity instruments based on the
grant-date fair value of the award. That cost will be recognized over the period during which an
employee is required to provide service in exchange for the award. We expect to adopt the
provisions of Statement No. 123(R) when it becomes a mandatory requirement, currently expected to be
January 1, 2006. The adoption of this statement is expected to result in significantly higher
reported operating expenses in our future financial statements. Had we adopted the provisions of
Statement No. 123(R) as of January 1, 2005, our reported loss for the three-month period-ended March
31, 2005 would have been $1,982,000 higher, or $7,250,000.
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. Failure to satisfactorily achieve
any of our objectives or avoid any of the risks described below or other risks listed in our Annual
Report on Form 10-K would likely have a material adverse effect on our business and results of
operations.
Risks Related to Our Business
Our losses will continue to increase as we expand our development efforts, and our efforts may
never result in profitability.
Our cumulative losses since our inception in 1987 through March 31, 2005 were in excess of
$170 million. We lost approximately $12 million in 2004, $10 million in 2003, $18 million in 2002
and approximately $5 million in the three-month period ended March 31, 2005. We expect to continue
to incur losses in the future, particularly as we continue to invest in the development of our drug
product candidates, acquire additional drug candidates and expand the scope of our operations. We
recently received approval to market our first generic drug product, ciprofloxacin, in the United
States and recorded modest revenue in 2004 and no revenue in the first quarter of 2005. We
currently do not sell any other products or services and we may never achieve significant revenues
from sales of products or become profitable. Even if we eventually generate significant revenues
from sales, we will likely continue to incur losses over the next several years.
Our business does not generate the cash needed to finance our ongoing operations and therefore, we
will need to raise additional capital.
Our current business operations do not generate sufficient operating cash to finance the
clinical development of our drug product candidates. We have historically relied primarily on
raising capital through the sale of our securities and out-licensing our drug candidates and
technology to meet our financial needs. While anticipated profits from the sale of generic drugs,
if we are successful in generating significant revenues from generics, may help defray some of the
expenses of operating our business, we believe that in order to prepare the company for continued
future drug product development and acquisition, and to capitalize on growth opportunities, we
will, for the foreseeable future, need to continue to raise funds through public or private
financings.
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 research and
drug development activities. An inability to raise additional capital would also impact our ability
to expand operations.
25
Clinical trials may fail to demonstrate the safety and efficacy of our proprietary drug
candidates, which could prevent or significantly delay obtaining regulatory approval.
Prior to receiving approval to commercialize any of our proprietary drug candidates, we must
demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction
of the FDA and other regulatory authorities in the United States and other countries, that each of
the products is both safe and effective. For each product candidate, we will need to demonstrate
its efficacy and monitor its safety throughout the process. If such development is unsuccessful,
our business and reputation would be harmed and our stock price would be adversely affected.
All of our product candidates are prone to the risks of failure inherent in drug development.
The results of pre-clinical studies and early-stage clinical trials of our product candidates do
not necessarily predict the results of later-stage clinical trials. Later-stage clinical trials may
fail to demonstrate that a product candidate is safe and effective despite having progressed
through initial clinical testing. Even if we believe the data collected from clinical trials of our
drug candidates are promising, such data may not be sufficient to support approval by the FDA or
any other United States or foreign regulatory approval. Pre-clinical and clinical data can be
interpreted in different ways. Accordingly, FDA officials could interpret such data in different
ways than we or our partners do, which could delay, limit or prevent regulatory approval. The FDA,
other regulatory authorities, our institutional review boards, our contract research organization,
or we may suspend or terminate our clinical trials for our drug candidates. Any failure or
significant delay in completing clinical trials for our product candidates, or in receiving
regulatory approval for the sale of any drugs resulting from our drug candidates, may severely harm
our business and reputation. Even if we receive FDA and other regulatory approvals, our product
candidates may later exhibit adverse effects that may limit or prevent their widespread use, may
cause the FDA to revoke, suspend or limit their approval, or may force us to withdraw products
derived from those candidates from the market.
Our proprietary drug candidates, their target indications, and status of development are
summarized in the following table:
The development of our drug candidate, satraplatin, depends on the efforts of a third party and,
therefore, its eventual success or commercial viability is largely beyond our control.
In 2002, we entered into a co-development and license agreement with GPC Biotech AG for the
development and commercialization of our lead drug candidate, satraplatin. GPC Biotech has agreed
to fully fund development and commercialization expenses for satraplatin. We do not have control
over the drug development process and therefore the success of our lead drug candidate depends upon
the efforts of GPC Biotech. GPC Biotech may not be successful in the clinical development of the
drug, the achievement of any additional milestones such as the acceptance of a New Drug
Application, or NDA, filing by the FDA, or the eventual commercialization of satraplatin.
The development of our drug candidate, SPI-153, may be adversely affected by the development
efforts of Zentaris GmbH who retained certain rights to the product.
Zentaris GmbH licensed the rights to us to develop and market SPI-153 in the United States,
Canada, Mexico and India. Zentaris may conduct their own clinical trials on SPI-153 for regulatory
approval in other parts of the
26
world. We will not have control over Zentaris efforts in this area and our own development
efforts for SPI-153 may be adversely impacted if their efforts are not successful.
From time to time we may need to license proprietary technologies from third parties, which may be
difficult or expensive to obtain.
We may need to obtain licenses to patents and other proprietary rights held by third parties
to successfully develop, manufacture and market our drug products. As an example, it may be
necessary to use a third partys proprietary technology to reformulate one of our drug products in
order to improve upon the capabilities of the drug product. If we are unable to timely obtain these
licenses on reasonable terms, our ability to commercially exploit our drug products may be
inhibited or prevented.
Our limited experience at managing and conducting clinical trials ourselves may delay the trials
and increase our costs.
We may manage and conduct some future clinical trials ourselves rather than hiring outside
clinical trial contractors. While some of our management has had experience at conducting clinical
trials, we have limited experience in doing so as a company. If we move forward with self-conducted
clinical trials, our limited experience may delay the completion of our clinical trials and
increase our costs.
The inability to retain and attract key personnel could significantly hinder our growth strategy
and might cause our business to fail.
Our success depends upon the contributions of our key management and scientific personnel,
especially Dr. Rajesh C. Shrotriya, our Chairman, President and Chief Executive Officer and Dr.
Luigi Lenaz, our Chief Scientific Officer. Dr. Shrotriya has been President since 2000 and Chief
Executive Officer since 2002, and has spearheaded the major changes in our business strategy and
coordinated our structural reorganization. Dr. Lenaz has been President of our Oncology Division
from November 2000 to February 2005 and Chief Scientific Officer since 2005, and has played a key
role in the identification and development of our proprietary drug candidates. The loss of the
services of Dr. Shrotriya, Dr. Lenaz or any other key personnel could delay or preclude us from
achieving our business objectives. Dr. Shrotriya has an employment agreement with us that will
expire on December 31, 2005, with automatic one-year renewals thereafter unless we, or Dr.
Shrotriya, give notice of intent not to renew at least 90 days in advance of the renewal date. Dr.
Lenaz has an employment agreement with us that will expire on July 1, 2006, with automatic one year
renewals thereafter unless we or Dr. Lenaz give notice of intent not to renew at least 90 days in
advance of the renewal date.
We also may need substantial additional expertise in marketing and other areas in order to
achieve our business objectives. Competition for qualified personnel among pharmaceutical companies
is intense, and the loss of key personnel, or the delay or inability to attract and retain the
additional skilled personnel required for the expansion of our business, could significantly damage
our business.
We are dependent on third parties for clinical testing, manufacturing and marketing our proposed
proprietary products. If we are not able to secure favorable arrangements with such third parties,
our business and financial condition could be harmed.
We may not conduct clinical trials ourselves, and we will not manufacture any of our proposed
proprietary products for commercial sale nor do we have the resources necessary to do so. In
addition, we currently do not have the capability to market our drug products ourselves. We intend
to contract with larger pharmaceutical companies or contract research organizations to conduct such
activities. In connection with our efforts to secure corporate partners, we may seek to retain
certain co-promotional or co-marketing rights to certain of our proprietary drug candidates, so
that we may promote our products to selected medical specialists while our corporate partner
promotes these products to the medical market generally. We may not be able to enter into any
partnering arrangements on this or any other basis. If we are not able to secure adequate
partnering arrangements, our business and financial condition could be harmed. In addition, we will
have to hire additional employees or consultants, since our current employees have limited
experience in these areas. Sufficient employees with relevant skills may not be
27
available to us. Any increase in the number of our employees would increase our expense level,
and could have an adverse effect on our financial position.
In addition, we, or our potential corporate partners, may not successfully introduce our
proposed proprietary products or our proposed proprietary products may not achieve acceptance by
patients, health care providers and insurance companies. Further, it is possible that we may not be
able to secure arrangements to manufacture and market our proposed proprietary products at prices
that would permit us to make a profit. To the extent that clinical trials are conducted by
corporate partners, we may not be able to control the design and conduct of these clinical trials.
Our efforts to acquire or in-license and develop additional proprietary drug candidates may fail,
which would limit our ability to grow our proprietary business.
The long-term success of our strategy depends in part on obtaining drug candidates in addition
to our existing portfolio. We are actively seeking to acquire, or in-license, additional
proprietary drug candidates that demonstrate the potential to be both medically and commercially
viable. We have certain criteria that we are looking for in any drug candidate acquisition and we
may not be successful in locating and acquiring, or in-licensing, additional desirable drug
candidates on acceptable terms.
We are a small company relative to our principal competitors and our limited financial resources
may limit our ability to develop and market our drug products.
Many companies, both public and private, including well-known pharmaceutical companies and
smaller niche-focused companies, are developing products to treat all of the diseases we are
pursuing, or distributing generic drug products directly competitive to the generic drugs we intend
to market and distribute. Many of these companies have substantially greater financial, research
and development, manufacturing, marketing and sales experience and resources than us. As a result,
our competitors may be more successful than us in developing their products, obtaining regulatory
approvals and marketing their products to consumers.
Competition for branded proprietary drugs is less driven by price and is more focused on
innovation in treatment of disease, advanced drug delivery and specific clinical benefits over
competitive drug therapies. We have six proprietary drug candidates currently under development. We
may not be successful in any or all of these studies; or if successful, and if one or more of our
proprietary drug candidates is approved by the FDA, we may encounter direct competition from other
companies who may be developing products for similar or the same indications as our drug
candidates. Companies active in the areas of oncology which is our focus include Astra Zeneca,
Amgen, Inc., Bayer AG, Eli Lilly and Co., Genentech, Inc., Novartis Pharmaceuticals Corporation,
Bristol-Myers Squibb Company, GlaxoSmithKline, Biogen-IDEC Pharmaceuticals, Inc., Guilford
Pharmaceuticals, Inc., Cephalon, Inc., Sanofi-Aventis Inc., Pfizer, Inc., Chiron Corp., Genta Inc.,
Imclone Systems Incorporated, MGI Pharma, Inc., SuperGen, Inc., Roche Pharmaceuticals and others
who are more established and are currently marketing products for the treatment of various forms of
cancer including the forms our oncology drug candidates target. Many of our competitors are large
and well capitalized companies focusing on a wide range of diseases and drug indications, and have
substantially greater financial, research and development, human and other resources than we do.
Furthermore, large pharmaceutical companies have significantly more experience than we do in
pre-clinical testing, human clinical trials and regulatory approval procedures, among other things
Any proprietary product for which we obtain FDA approval must compete for market acceptance
and market share. For example, cisplatin injection and carboplatin injection are the most prevalent
platinum-based derivatives used in chemotherapy and are the primary treatment for many of the
cancer types we are pursuing. Our drug candidate, satraplatin, if the FDA approves it for sale,
would likely compete against these drugs directly. Unless satraplatin is shown to have better
efficacy and is as cost effective, if not more cost effective, than cisplatin and carboplatin, it
may not gain acceptance by the medical field and therefore may never be successful commercially.
With regard to our drug product candidate, RenaZorb, under the new National Kidney
Foundation K/DOQI guidelines for treating hyperphosphatemia, non-calcium, non-aluminum binders are
the recommended first-line long-term therapy for managing high phosphate levels. Genzyme
corporationss Renagel® and Shire Pharmaceuticals Fosrenol® are the only two FDA approved
non-calcium, non-aluminum, branded pharmaceuticals
28
specifically for the treatment of hyperphosphatemia in end stage renal disease. We expect to
compete with these products and potentially others based upon phosphate binding capacity, patient
compliance, side effects and cost. While we believe RenaZorb has the potential to perform better
than these competitors, if RenaZorb is successfully developed and receives FDA approval, it will
be a number of years after Renagel® and Fosrenol® have been FDA approved and marketed. In addition,
Genzyme and Shire may seek to modify their products or create new therapies that could reduce or
eliminate any perceived benefit we believe RenaZorb may have over these products.
Our success in the marketing of our generic drug products will depend significantly upon our
ability to forecast market conditions that may prevail after we obtain ANDA approval and identify
generic drugs that our strategic partners and associated suppliers can produce for us
cost-effectively. In addition, we must be able to expand our marketing, selling and distribution
relationships in the United States since we currently do not have any internal distribution
capabilities and an alliance with a single product distributor. Furthermore, as a new generic
competitor entering the marketplace, which is made up of many well-established companies, with
established customers as well as established sales, marketing and distribution organizations we may
not be able to successfully compete.
Because price is the primary basis for competition among generic versions of a given drug, any
ability by our competitors to reduce production costs can provide them with a significant
competitive advantage, and our ability to compete will be largely dependent on our ability to
obtain supplies of our generic drug product from manufacturers at favorable prices. As a new
generic competitor, we will be competing against established generic companies such as Teva
Pharmaceuticals, Sandoz, Barr Laboratories, Mylan Laboratories Inc., Watson Pharmaceuticals, Inc.,
Genpharm, Dr. Reddys, Ranbaxy, American Pharmaceutical Partners, Bedford Laboratories and others.
These companies may have greater economies of scale in the production of their products and, in
certain cases, may produce their own product supplies, such as active pharmaceutical ingredients,
or can procure product supplies on more favorable terms which may provide significant cost and
supply advantages to customers in the retail prescription market. We expect that the generic
market will be competitive and will be largely dominated by the competitors listed above who will
target many, if not all, of the same products for development as us.
We currently have nine generic drug candidates under review at the FDA. For ciprofloxacin
tablets, our first generic product candidate filed with FDA, and for which we obtained approval in
September 2004, there are currently fifteen generic manufacturers approved to sell versions of
ciprofloxacin tablets, which include Apotex, Barr, Cobalt, Taro, Teva, West Ward, Eon Labs,
Carlsbad Technology, IVAX, Sandoz, Genpharm, Ranbaxy, Dr. Reddys, Martec and Mylan Laboratories,
Inc. The pediatric exclusivity for Diflucan, the branded form of fluconazole, our second generic
product filed with the FDA, expired on July 29, 2004. The market is very competitive with versions
from generic drug manufacturers such as Taro Pharmaceutical Industries, Mylan Laboratories, Inc,
Sandoz, Ranbaxy, IVAX, Genpharm, Gedeon Richter, TEVA, Torpharm, Roxane and Pliva approved by the
FDA for sale in the U.S. We have not yet obtained approval from the FDA for fluconazole tablets and
can give no assurance for when approval is likely to come, if at all. Carboplatin injection, our
third generic drug ANDA filed with FDA, is the generic equivalent of Bristol Meyers Squibbs brand
Paraplatin, for which the patent expired in April 2004. The FDA granted approval, following the
expiration of pediatric exclusivity in October 2004, for carboplatin injection to five generic
companies, including Pharmachemie, APP, Bedford, Mayne and Pliva. TEVA Pharmaceuticals, through an
agreement with Bristol Myers Squibb, is currently selling carboplatin injection produced by Bristol
Myers Squibb as a generic drug. We have not yet obtained approval from the FDA for carboplatin
injection and can give no assurance for when approval is likely to come, if at all. The patent for
Imitrex® injection, the brand name for sumatriptan succinate injection, for which we filed an ANDA
with paragraph IV certification, has not yet expired. However, we have initiated a challenge of the
patent and are currently in litigation with GlaxoSmithKline, the patent holder for Imitrex®
injection. Based on the guidelines available to us, and our experience with the FDA approval
process, we do not anticipate receiving approval for our six other ANDAs, filed in 2004 and in
2005, before the first quarter of 2006, if at all, and all approvals will come after patents and/or
exclusivities expire and after some of our competitors have already obtained approval and begun
marketing.
29
Our proprietary drug candidates may not be more effective, safer or more cost efficient than
competing drugs and otherwise may not have any competitive advantage, which could hinder our
ability to successfully commercialize our drug candidates.
Drugs produced by other companies are currently on the market for each disease type we are
pursuing. Even if one or more of our drug candidates ultimately received FDA approval, our drug
candidates may not have better efficacy in treating the target indication than a competing drug,
may not have a more favorable side-effect profile than a competing drug, may not be more cost
efficient to manufacture or apply, or otherwise may not demonstrate a competitive advantage over
competing therapies. Accordingly, even if FDA approval is obtained for one or more of our drug
candidates, they may not gain acceptance by the medical field or become commercially successful.
Price and other competitive pressures may make the marketing and sale of our generic drugs not
commercially feasible and not profitable.
The generic drug market in the United States is extremely competitive, characterized by many
participants and constant downward price pressure on generic drug products. Consequently, margins
are continually reduced and it is necessary to continually introduce new products to achieve and
maintain profitability. We have only obtained regulatory approval for one of our generic drug
candidates. While we have entered into agreements with third parties to manufacture the drug
products for us, given the price volatility of the generic market, we believe it is imprudent to
enter into definitive agreements on transfer prices with the manufacturers of our generic drug
product candidates prior to FDA approval, and we do not expect to do so until we receive FDA
approval and are ready to begin selling the generic drug products. Our ability to compete
effectively in the generic drug market depends largely on our ability to obtain transfer price
agreements that ensure a supply of our generic drug products at favorable prices. Even if we obtain
regulatory approval to market one or more generic drug candidates in the United States, we may not
be able to complete a transfer price arrangement with the manufacturers of the drug candidates that
will allow us to market any generic drug products in the United States on terms favorable to us, or
at all.
Also, if we fail to obtain approval of our ANDAs from the FDA in a timely manner, preferably
before the patent and any additional exclusivity granted by the FDA to the branded drug product
expire, our profitability will be significantly affected due to the significant price erosion
caused by the typically large number of the generic companies entering the market. The U.S. patent
and pediatric exclusivity for Cipro®, the branded form of our generic drug product ciprofloxacin,
had both expired by June 2004. We received approval from the FDA of our ANDA for ciprofloxacin
tablets in September 2004, however, fifteen other companies have received FDA approval to market
generic versions of ciprofloxacin tablets, and we have observed a significant reduction in the
market price for ciprofloxacin since June 2004. The patents and all exclusivities for our four
ophthalmic products and our two undisclosed product have previously expired, and a number of other
companies are currently selling their own generic versions of the products. In addition, we did not
obtain approval of our ANDAs for fluconazole tablets and carboplatin injection prior to the
expirations in July and October 2004, respectively, of the patents and exclusivities granted by the
FDA to the corresponding branded products. Consequently, our ability to achieve a profit may be
significantly harmed as we have observed significant reductions in the market prices for these
products as well. The patents for sumatriptan succinate injection, the generic version of Imitrex®,
marketed by GlaxoSmithKline, for which we filed an ANDA with paragraph IV certification in October
2004, have not yet expired.
In addition to competitive pressures related to price, we may face opposition from the
producers of the branded versions of the generic drugs for which we obtain approval. Branded
pharmaceutical companies have aggressively sought to prevent generic competition, including the
extensive use of litigation. On February 18, 2005, GlaxoSmithKline filed suit in U.S. federal court
to prevent us from proceeding with the commercialization of our generic version of Imitrex® which action
formally initiates our challenge of the patent listed by GlaxoSmithKline in connection with
Imitrex® injection. For information regarding the risks of this litigation, please see the
risk factor below.
In addition, many branded pharmaceutical companies increasingly have used state and federal
legislative and regulatory means to delay generic competition. These efforts have included:
30
We may not be successful in expanding our generic drug distribution capabilities in the United
States, our only target market for generic drugs, which would limit our ability to grow our
generic drug business.
Many of our competitors have substantial, established direct and indirect distribution
channels. We have not yet undertaken the marketing and distribution of a generic drug product
ourselves and we currently have no direct sales and marketing organization and our limited sales
and marketing resources are devoted to establishing and enhancing our third party distribution
relationships.
We
have established relationships with distributors for the distribution
of ciprofloxacin tablets and
carboplatin injection; and commenced distribution of ciprofloxacin tablets during the fourth
quarter of 2004. The long-term success in the marketing of our generic drugs will depend in part on
our drug distribution capabilities in the U.S., our only target market for generic drugs. We may
not be successful in expanding our existing distribution channel, establishing new, additional
distribution channels or establishing a direct generic drug marketing capability sufficient to
effectively and successfully compete in the generic drug market
We may not be successful in establishing additional generic drug supply relationships, which would
limit our ability to grow our generic drug business.
Long-term success in the marketing of generic drugs depends in part on our ability to expand
and enhance our existing relationships and establish new relationships for supplying generic drug
products. We do not presently intend to focus our research and development efforts on developing
active pharmaceutical ingredients or the dosage form for generic drugs. In addition, we currently
have no capacity to manufacture generic drug products and do not intend to spend our capital
resources to develop the capacity to do so. Therefore, we must rely on relationships with other
companies to supply our generic drug products. We may not be successful in expanding or enhancing
our existing relationships or in securing new relationships. If we fail to expand our existing
relationships or secure new relationships, our ability to expand our generic drug business will be
harmed.
Our supply of drug products will be dependent upon the production capabilities of our supply
sources, which may limit our ability to meet demand for our products and ensure regulatory
compliance.
We have no internal manufacturing capacity for our drug product candidates, and therefore, we
have entered into agreements with third-party manufacturers to supply us with our drug products,
subject to further agreement on pricing for particular drug products. Consequently, we will be
dependent on our manufacturing partners for our supply of drug products. Some of these
manufacturing facilities are located outside the United States. The manufacture of drug products,
including the acquisition of compounds used in the manufacture of the finished drug product, may
require considerable lead times. Further, with regard to our generic drug products, sales of a new
generic drug product may be difficult to forecast. We will have little or no control over the
production process. Accordingly, while we do not currently anticipate shortages of supply, there
could arise circumstances in which market demand for a particular generic product could outstrip
the ability of our supply source to timely manufacture and deliver the product, thereby causing us
to lose sales.
Reliance on a third-party manufacturers entails risks to which we would not be subject if we
manufactured products ourselves, including reliance on the third party for regulatory compliance
and adhering to FDAs current Good Manufacturing Practices, or cGMP, requirements, the possible
breach of the manufacturing agreement by the third party because of factors beyond our control and
the possibility of termination or non-renewal of the agreement by the third party, based on its own
business priorities, at a time that is costly or inconvenient for us. Before we can obtain
marketing approval for our product candidates, our suppliers manufacturing facilities must pass an
FDA pre-approval inspection. In order to obtain approval, all of the facilitys manufacturing
methods, equipment and processes must comply with cGMP requirements. The cGMP requirements govern
all areas of record keeping, production processes and controls, personnel and quality control. Any
failure of our third-party manufacturers or us
31
to comply with applicable regulations, including an FDA pre-approval inspection and cGMP
requirements, could result in sanctions being imposed on us, including fines, injunctions, civil
penalties, failure of regulatory authorities to grant marketing approval of our products, delay,
suspension or withdrawal of approvals, license revocation, seizures or recalls of product,
operation restrictions and criminal prosecutions, any of which could significantly and adversely
affect our business.
GlaxoSmithKline filed suit in U.S. federal court asserting that Spectrum has infringed their
patent for Imitrex® injection by filing our ANDA for sumatriptan injection, the generic form of
Imitrex® injection. This challenge may prevent us from commercializing sumatriptan until after the
patent has expired and may require us to incur substantial expense and the significant effort of
technical and management personnel.
On February 18, 2005, GlaxoSmithKline filed suit in U.S. federal court to prevent us from
proceeding with the commercialization of our generic form of sumatriptan injection. Since patent
litigation has been initiated, the FDA will not approve our ANDA until the earlier of 30 months
from when GlaxoSmithKlines filed suit in federal court alleging
patent infringement of their Orange Book-listed patent (the 30-month stay) or the
issuance of a final non-appealed, or non-appealable court decision finding the Imitrex® patent
invalid, unenforceable or not infringed. If the patent is found to be infringed by the filing of
our ANDA, GlaxoSmithKline could seek an injunction to block the launch of our generic product until
the patent expires. This would prohibit us from obtaining the 180-day marketing exclusivity
afforded by the FDA to companies who are the first to file an ANDA with a paragraph IV
certification for a generic equivalent to a brand name product. We believe we are the first to file
an ANDA with a paragraph IV certification for sumatriptan injection.
Our defense against the charge of infringement by GlaxoSmithKline could require us to incur
substantial legal expense and to divert significant effort of our technical and management
personnel away from their regular activities in our business, which could substantially hinder our
ability to conduct, advance and grow our business.
Risks Related to Our Industry
Rapid technological advancement may render our drug candidates obsolete before we recover expenses
incurred in connection with their development. As a result, our drug products may never become
profitable.
The pharmaceutical industry is characterized by rapidly evolving technology. Technologies
under development by other pharmaceutical companies could result in treatments for diseases and
disorders for which we are developing our own treatments. Several other companies are engaged in
research and development of compounds that are similar to our research. A competitor could develop
a new technology, product or therapy that has better efficacy, a more favorable side-effect profile
or is more cost effective than one or more of our drug candidates and thereby cause our drug
candidate to become commercially obsolete. Some drug candidates may become obsolete before we
recover the expenses incurred in their development. As a result, such products may never become
profitable.
Competition for patients in conducting clinical trials may prevent or delay product development
and strain our limited financial resources.
Many pharmaceutical companies are conducting clinical trials in patients with the disease
indications that our drug candidates target. As a result, we must compete with them for clinical
sites, physicians and the limited number of patients who fulfill the stringent requirements for
participation in clinical trials. Also, due to the confidential nature of clinical trials, we do
not know how many of the eligible patients may be enrolled in competing studies and consequently
not available to us. Our clinical trials may be delayed or terminated due to the inability to
enroll enough patients to complete our clinical trials. Patient enrollment depends on many factors,
including the size of the patient population, the nature of the trial protocol, the proximity of
patients to clinical sites and the eligibility criteria for the study. The delay or inability to
meet planned patient enrollment may result in increased costs and delays or termination of the
trial, which could have a harmful effect on our ability to develop products.
32
We may not be successful in obtaining regulatory approval to market and sell our proprietary or
generic drug candidates.
Before our proprietary drug candidates can be marketed and sold, regulatory approval must be
obtained from the FDA and comparable foreign regulatory agencies. We must demonstrate to the FDA
and other regulatory authorities in the United States and abroad that our product candidates
satisfy rigorous standards of safety and efficacy. We will need to conduct significant additional
research, pre-clinical testing and clinical testing, before we can file applications with the FDA
for approval of our product candidates. The process of obtaining FDA and other regulatory approvals
is time consuming, expensive, and difficult to design and implement. The review and approval, or
denial, process for an application can take years. The FDA, or comparable foreign regulatory
agencies, may not timely, or ever, approve an application. Among the many possibilities, the FDA
may require substantial additional testing or clinical trials or find our drug candidate is not
sufficiently safe or effective in treating the targeted disease. This could result in the denial or
delay of product approval. Our product development costs will increase if we experience delays in
testing or approvals. Further, a competitor may develop a competing drug or therapy that impairs or
eliminates the commercial feasibility of our drug candidates.
In order to obtain approval for our generic drug candidates, we will need to scientifically
demonstrate that our drug product is safe and bioequivalent to the innovator drug. Bioequivalency
may be demonstrated by comparing the generic drug candidate to the innovator drug product in dosage
form, strength, route of administration, quality, performance characteristics and intended use. We
plan to use our managements experience with the regulatory approval process in the United States
to prepare, file and prosecute appropriate Abbreviated New Drug Applications, or ANDAs, for our
current and future generic drug candidates. Since 2003 we have filed ten ANDAs with the FDA. In
September 2004, we received approval from the FDA to market ciprofloxacin tablets in the United
States. We intend to file additional ANDAs in the foreseeable future. The FDA may not agree that
our safety and bioequivalency studies provide sufficient support for approval. This could result in
denial or delay of FDA approval of our generic products. Generic drugs generally have a relatively
short window in which they can be profitable before other manufacturers introduce competing
products that impose downward pressure on prices and reduce market share for other versions of the
generic drug. Consequently, delays in obtaining FDA approval may also significantly impair our
ability to compete.
Our failure to comply with extensive governmental regulation to which we are subject may delay or
prevent approval of our product candidates and may subject us to penalties.
The FDA and comparable agencies in foreign countries impose many requirements on the
introduction of new drugs through lengthy and detailed clinical testing and data collection
procedures, and other costly and time consuming compliance procedures. These requirements apply to
every stage of the clinical trial process and make it difficult to estimate when any of our drug
candidates will be available commercially, if at all. While we believe that we are currently in
compliance with applicable FDA regulations, if we, our partners, or contract research organizations
fail to comply with the regulations applicable to our clinical testing, the FDA may delay, suspend
or cancel our clinical trials, or the FDA might not accept the test results. The FDA, an
institutional review board at our clinical trial sites, our third-party investigators, any
comparable regulatory agency in another country, or we, may suspend clinical trials at any time if
the trials expose subjects participating in such trials to unacceptable health risks. Further,
human clinical testing may not show any current or future product candidate to be safe and
effective to the satisfaction of the FDA or comparable regulatory agencies or the data derived from
the clinical tests may be unsuitable for submission to the FDA or other regulatory agencies.
Once we submit a drug candidate for commercial sale approval, the FDA or other regulatory
agencies may not issue their approvals on a timely basis, if at all. If we are delayed or fail to
obtain these approvals, our business and prospects may be significantly damaged. Even if we obtain
regulatory approval for our product candidates, we, our partners, our manufacturers, and other
contract entities will continue to be subject to extensive requirements by a number of national,
foreign, state and local agencies. These regulations will impact many aspects of our operations,
including testing, research and development, manufacturing, safety, effectiveness, labeling,
storage, quality control, adverse event reporting, record keeping, approval, advertising and
promotion of our future products. Failure to comply with applicable regulatory requirements could,
among other things, result in:
33
The later discovery of previously unknown problems with our products may result in
restrictions of the product candidate, including withdrawal from manufacture. In addition, the FDA
may revisit and change its prior determinations with regard to the safety and efficacy of our
future products. If the FDAs position changes, we may be required to change our labeling or to
cease manufacture and marketing of the challenged products. Even prior to any formal regulatory
action, we could voluntarily decide to cease the distribution and sale or recall any of our future
products if concerns about their safety or effectiveness develop.
In their regulation of advertising, the FDA and the Federal Trade Commission from time to time
issue correspondence alleging that some advertising or promotional practices are false, misleading
or deceptive. The FDA has the power to impose a wide array of sanctions on companies for such
advertising practices, and the receipt of correspondence from the FDA alleging these practices
could result in any of the following:
If we were to become subject to any of the above requirements, it could be damaging to our
reputation, and our business condition could be adversely affected.
Physicians may prescribe pharmaceutical products for uses that are not described in a
products labeling or differ from those tested by us and approved by the FDA. While such
off-label uses are common and the FDA does not regulate physicians choice of treatments, the FDA
does restrict a manufacturers communications on the subject of off-label use. Companies cannot
actively promote FDA-approved pharmaceutical products for off-label uses, but they may disseminate
to physicians articles published in peer-reviewed journals. If our promotional activities fail to
comply with the FDAs regulations or guidelines, we may be subject to warnings from, or enforcement
action by, the FDA.
Legislative or regulatory reform of the healthcare system and pharmaceutical industry may hurt our
ability to sell our products profitably or at all.
In both the United States and certain foreign jurisdictions, there have been and may continue
to be a number of legislative and regulatory proposals to change the healthcare system and
pharmaceutical industry in ways that could impact upon our ability to sell our products profitably.
For example, sales of our products will depend in part on the availability of reimbursement from
third-party payers such as government health administration authorities, private health insurers,
health maintenance organizations including pharmacy benefit managers and other health care-related
organizations. Both the federal and state governments in the United States and foreign governments
continue to propose and pass new legislation, rules and regulations designed to contain or reduce
the cost of health care. As an example, the Medicare Prescription Drug, Improvement and
Modernization Act of 2003, or the Medicare Modernization Act, was recently enacted. This legislation
provides a new Medicare prescription drug benefit
34
beginning in 2006 and mandates other reforms. Also, the passage of the Medicare Modernization
Act reduces reimbursement for certain drugs used in the treatment of cancer. Although we cannot
predict the full effects on our business of the implementation of this new legislation, it is
possible that the new benefit, which will be managed by private health insurers, pharmacy benefit
managers and other managed care organizations, will result in decreased reimbursement for
prescription drugs, which may further exacerbate industry-wide pressure to reduce the prices
charged for prescription drugs. This could harm our ability to market our products and generate
revenues.
It is also possible that other proposals will be adopted. As a result of the new Medicare
prescription drug benefit, or any other proposals, we may determine to change our current manner of
operation, which could harm our ability to operate our business efficiently. Existing regulations
that affect the price of pharmaceutical and other medical products may also change before any of
our products are approved for marketing. Cost control initiatives could decrease the price that we
receive for any of our products we are developing. In addition, third-party payers are increasingly
challenging the price and cost-effectiveness of medical products and services. Significant
uncertainty exists as to the reimbursement status of newly approved pharmaceutical products. Our
products may not be considered cost effective, or adequate third-party reimbursement may not be
available to enable us to maintain price levels sufficient to realize a return on our investments.
In addition, new court decisions, FDA interpretations, and legislative changes have modified
the rules governing eligibility for and the timing of 180-day market exclusivity periods, a period
of marketing exclusivity that the FDA may grant to an ANDA applicant who is the first to file a
legal challenge to patents of branded drugs. We believe we were the first to file an ANDA for
sumatriptan succinate injection, the generic form of GlaxoSmithKlines Imitrex® injection, and are
currently in litigation with GlaxoSmithKline regarding the patent that covers this product.
However, it is difficult to predict the effects such changes may have on our business or our
current case. Any changes in FDA regulations, procedures, or interpretations may make ANDA
approvals of generic drugs more difficult or otherwise limit the benefits available to us through
the granting of 180-day marketing exclusivity. If we are not able to exploit the 180-day
exclusivity period for our sumatriptan succinate injection ANDA or one of our generic product
candidates that we were first to file, for any reason, our product may not gain market share, which
could materially adversely affect our results of operations.
As part of the Medicare Modernization Act, companies are now required to file with the Federal
Trade Commission and the Department of Justice certain types of agreements entered into between
branded and generic pharmaceutical companies related to the manufacture, marketing and sale of
generic versions of branded drugs. This new requirement could affect the manner in which generic
drug manufacturers resolve intellectual property litigation and other disputes with branded
pharmaceutical companies, and could result generally in an increase in private-party litigation
against pharmaceutical companies. The impact of this new requirement, and the potential
private-party lawsuits associated with arrangements between brand name and generic drug
manufacturers, is uncertain and could adversely affect our business.
Additional government regulations, legislation, or policies may be enacted which could prevent
or delay regulatory approval of our product candidates. We cannot predict the likelihood, nature or
extent of adverse government action that may arise from future legislation or administrative
action, either in the United States or abroad. If we are not able to maintain regulatory
compliance, we might not be permitted to market our products and our business could suffer.
If we
are unable to adequately protect our technology or enforce our
patent rights, our business could
suffer.
Our success with proprietary products that we develop will depend, in part, on our ability to
obtain and maintain patent protection for these products. We currently have a number of U.S. and
foreign patents issued and pending, however, we primarily rely on
patent rights licensed from others. These patents generally give us
the right and/or obligation to maintain and enforce the subject
patents. We cannot be sure that we will receive patents for any of our
pending patent applications or any patent applications we may file in the future. If our pending
and future patent applications are not approved or, if approved, if
such patents and the patents we have licensed are not upheld in
a court of law, it may reduce our ability to competitively exploit
our proprietary products would be substantially harmed. Also,
such patents may or may not provide competitive advantages for their respective products or they
may be challenged or circumvented by our competitors, in which case our ability to commercially
exploit these products may be diminished.
35
We also rely on trade secret protection and contractual protections for our unpatented,
confidential and proprietary technology. Trade secrets are difficult to protect. While we enter
into proprietary information agreements with our employees, consultants and others, these
agreements may not successfully protect our trade secrets or other confidential and proprietary
information. It is possible that these agreements will be breached, or that they will not be
enforceable in every instance, and that we will not have adequate remedies for any such breach. It
is also possible that our trade secrets will become known or independently developed by our
competitors.
If we are unable to adequately protect our technology, trade secrets or proprietary know-how,
or enforce our patents, our business, financial condition and prospects could suffer.
Intellectual property rights are complex and uncertain and therefore may subject us to
infringement claims.
The patent positions related to our proprietary and generic drug candidates are inherently
uncertain and involve complex legal and factual issues. Although we are not aware of any
infringement by any of our drug candidates on the rights of any third party, there may be third
party patents or other intellectual property rights relevant to our drug candidates of which we are
not aware. Third parties may assert patent or other intellectual property infringement claims
against us with respect to our proprietary drug candidates or our generic drug products. This could
draw us into costly litigation as well as result in the loss of our use of the intellectual
property that is critical to our business strategy.
Intellectual property litigation is increasingly common and increasingly expensive and may result
in restrictions on our business and substantial costs, even if we prevail.
Patent and other intellectual property litigation is becoming more common in the
pharmaceutical industry. Litigation is sometimes necessary to defend against or assert claims of
infringement, to enforce our patent rights including those we have licensed from others, including those we have licensed from others, to
protect trade secrets or to determine the scope and validity of proprietary rights of third
parties. Other than the lawsuit filed against us by GlaxoSmithKline related to our ANDA for
sumatriptan injection, currently no third party has asserted that we are infringing upon their
patent rights or other intellectual property, nor are we aware or believe that we are infringing
upon any third partys patent rights or other intellectual property. We may, however, be infringing
upon a third partys patent rights or other intellectual property, and litigation asserting such
claims might be initiated in which we would not prevail or we would not be able to obtain the
necessary licenses on reasonable terms, if at all. All such litigation, whether meritorious or not,
as well as litigation initiated by us against third parties, is time consuming and very expensive
to defend or prosecute and to resolve. In addition, if we infringe the intellectual property rights
of others, we could lose our right to develop, manufacture or sell our products or could be
required to pay monetary damages or royalties to license proprietary rights from third parties. An
adverse determination in a judicial or administrative proceeding or a failure to obtain necessary
licenses could prevent us from manufacturing or selling our products, which could harm our
business, financial condition and prospects.
If our competitors prepare and file patent applications in the United States that claim
technology we also claim, we may have to participate in interference proceedings required by the
Patent and Trademark Office to determine priority of invention, which could result in substantial
costs, even if we ultimately prevail. Results of interference proceedings are highly unpredictable
and may result in us having to try to obtain licenses in order to continue to develop or market
certain of our drug candidates.
We may be subject to product liability claims, and may not have sufficient product liability
insurance to cover any such claims, which may expose us to substantial liabilities.
We may be exposed to product liability claims from patients who participate in our clinical
trials or from consumers of our products. Although we currently carry product liability insurance
in the amount of at least $3 million in the aggregate, it is possible that this coverage will be
insufficient to protect us from future claims.
Further, we may not be able to maintain our existing insurance or obtain or maintain
additional insurance on acceptable terms for our clinical and commercial activities or that such
additional insurance would be sufficient to cover any potential product liability claim or recall.
Failure to maintain sufficient insurance coverage could have a material adverse effect on our business, prospects and results of operations if claims are
made that exceed our coverage.
36
The use of hazardous materials in our research and development efforts imposes certain compliance
costs on us and may subject us to liability for claims arising from the use or misuse of these
materials.
Our research and development efforts involved and currently involve the use of hazardous materials. We are subject to federal,
state and local laws and regulations governing the storage, use and disposal of these materials and
some waste products. We believe that our safety procedures for the storage, use and disposal of
these materials comply with the standards prescribed by federal, state and local regulations.
However, we cannot completely eliminate the risk of accidental contamination or injury from these
materials. If there were to be an accident, we could be held liable for any damages that result,
which could exceed our financial resources. We currently maintain insurance coverage for injuries
resulting from the hazardous materials we use, and for pollution clean up and removal; however,
future claims may exceed the amount of our coverage. Currently the costs of complying with federal,
state and local regulations are not significant, and consist primarily of waste disposal expenses.
Risks Related to Our Stock
There are a substantial number of shares of our common stock eligible for future sale in the
public market. The sale of these shares could cause the market price of our common stock to fall.
Any future equity issuances by us may have dilutive and other effects on our existing
stockholders.
As of March 31, 2005, there were approximately 15.3 million shares of our common stock
outstanding, and in addition, security holders held options, warrants and preferred stock which, if
exercised or converted, would obligate us to issue up to approximately 11 million additional shares
of common stock. A substantial number of those shares, when we issue them upon conversion or
exercise, will be available for immediate resale in the public market. In addition, we have filed a
shelf registration statement that allows us to sell up to $100 million of our securities, some or
all of which may be shares of our common stock or securities convertible into or exercisable for
shares of our common stock, and all of which would be available for immediate resale in the market.
We may issue and sell all of these securities within two years after January 24, 2005, the date of
the effectiveness of the registration statement. If we were to sell the full $100 million available
under the registration statement as common stock at a price equal to the current market price of
our common stock as of the date of the effectiveness of the registration statement, we would issue
approximately 16.0 million new shares of our common stock. The market price of our common stock
could fall as a result of resales of any of these shares of common stock due to the increased
number of shares available for sale in the market.
We have financed our operations, and for the foreseeable future we expect to continue to
finance a substantial portion of our operating cash requirements, primarily by issuing and selling
our common stock or securities convertible into or exercisable for shares of our common stock. Any
issuances by us of equity securities may be at or below the prevailing market price of our common
stock and may have a dilutive impact on our other stockholders. These issuances would also cause
our net income, if any, per share to decrease or our loss per share to decrease in future periods. As a
result, the market price of our common stock could drop.
The market price and volume of our common stock fluctuate significantly and could result in
substantial losses for individual investors.
The stock market from time to time experiences significant price and volume fluctuations that
are unrelated to the operating performance of particular companies. These broad market fluctuations
may cause the market price and volume of our common stock to decrease. In addition, the market
price and volume of our common stock is highly volatile. Factors that may cause the market price
and volume of our common stock to decrease include fluctuations in our results of operations,
timing and announcements of our technological innovations or new products or those of our
competitors, FDA and foreign regulatory actions, developments with respect to patents and
proprietary rights, public concern as to the safety of products developed by us or others, changes
in health care policy in the United States and in foreign countries, changes in stock market
analyst recommendations regarding our common stock, the pharmaceutical industry generally and
general market conditions. In addition, the market price and volume of our
37
common stock may decrease if our results of operations fail to meet the expectations of stock
market analysts and investors. While a decrease in market price could result in direct economic
loss for an individual investor, low trading volume could limit an individual investors ability to
sell our common stock, which could result in substantial economic loss as well. During 2004, the
price of our common stock ranged between $3.92 and $10.13, and the daily trading volume was as high
as 1,391,800 shares and as low as 9,900 shares. During 2005 through April 29, 2005, the price of
our common stock has ranged between $5.24 and $7.50, and the daily trading volume has been as high
as 360,200 shares and as low as 18,400 shares.
Provisions of our charter, bylaws and stockholder rights plan may make it more difficult for
someone to acquire control of us or replace current management even if doing so would benefit our
stockholders, which may lower the price an acquirer or investor would pay for our stock.
Provisions of our certificate of incorporation, as amended, and bylaws may make it more
difficult for someone to acquire control of us or replace our current management. These provisions
include:
These provisions may make it more difficult for stockholders to take certain corporate actions
and could delay, discourage or prevent someone from acquiring our business or replacing our current
management, even if doing so would benefit our stockholders. These provisions could limit the price
that certain investors might be willing to pay for shares of our common stock.
In December 2000, we adopted a stockholder rights plan pursuant to which we distributed rights
to purchase units of our Series B junior participating preferred stock. The rights become
exercisable upon the earlier of ten days after a person or group of affiliated or associated
persons has acquired 20% or more of the outstanding shares of our common stock or ten business days
after a tender offer has commenced that would result in a person or group beneficially owning 20%
or more of our outstanding common stock. These rights could delay or discourage someone from
acquiring our business, even if doing so would benefit our stockholders. We currently have no
stockholders who own 20% or more of the outstanding shares of our common stock.
We do not anticipate declaring any cash dividends on our common stock.
We have never declared or paid cash dividends on our common stock and do not plan to pay any
cash dividends in the near future. Our current policy is to retain all funds and any earnings for
use in the operation and expansion of our business.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
We are exposed to certain market risks associated with interest rate fluctuations and credit
risk on our cash equivalents and marketable securities, which investments are entered into for
purposes other than trading. The primary objective of our investment activities is to preserve
principal, while at the same time maximizing yields without significantly increasing risk. We do
not utilize hedging contracts or similar instruments.
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.
38
Our investments as of March 31, 2005 are primarily in 28 day auction rate notes. Because of
our ability to redeem these investments at par within a 28-day period, changes in interest rates
would have an immaterial effect on the fair value of these investments. If a 10% change in interest
rates were to have occurred on March 31, 2005, 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 have purchased. If these companies were to
experience a significant detrimental change in their credit ratings, the fair market value of such
corporate bonds may significantly decrease. If these companies were to default on these corporate
bonds, we may lose part or all of our principal. We believe that we effectively manage this market
risk by diversifying our investments, and selecting securities that generally have third party
insurance coverage in the event of default by the issuer.
ITEM 4. Controls and Procedures
We have established disclosure controls and procedures (as such terms are defined in Rules
13(a)-15(e) and 15(d)-15(e)) under the Securities Exchange Act of 1934), as amended (the Exchange
Act) that are designed to ensure that information required to be disclosed in our Exchange Act
reports is recorded, processed, summarized and reported within the time periods specified in the
SECs rules and forms, and that such information is accumulated and communicated to our management,
including our Chief Executive Officer (our principal executive officer) and Vice President Finance
(our principal financial officer), as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and procedures, our management is
required to apply its judgment in evaluating the cost-benefit relationship of possible controls and
procedures. Our disclosure controls and procedures are designed to provide a reasonable level of
assurance of reaching our desired disclosure control objectives.
As required by SEC Rule 13a-15(b), we carried out an evaluation, under the supervision and
with the participation of our management, including our Chief Executive Officer and our Vice
President Finance, of the effectiveness of the design and operation of our disclosure controls and
procedures as of March 31, 2005, the end of the period covered by this report (Evaluation Date).
Based on the foregoing, our Chief Executive Officer and Vice President Finance concluded that our
disclosure controls and procedures were effective and were operating at the reasonable assurance
level.
There has been no change in our internal controls over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to materially affect,
our internal controls over financial reporting.
39
PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
Sumatriptan succinate injection Paragraph IV Litigation
In October 2004, we filed with the FDA an ANDA for sumatriptan succinate injection 6mg/0.5mL,
seeking approval to engage in the commercial manufacture, sale, and use of the sumatriptan
succinate injection product in the United States. Sumatriptan succinate is marketed by
GlaxoSmithKline under the brand name Imitrex® and is used for the acute treatment of migraine
attacks with or without aura and the acute treatment of cluster headache episodes in adults.
GlaxoSmithKline has two patents for sumatriptan succinate injection listed in the FDAs Orange
Book, which is the FDAs listing of approved drug products. The exclusivity afforded the patents
listed in the Orange Book for Imitrex® injection expire on June 28, 2007 and February 6, 2009, in
each case including extensions for pediatric exclusivity. Our ANDA includes a Paragraph IV
certification that the later to expire patent associated with GlaxoSmithKlines Imitrex® injection,
is invalid, unenforceable and/or will not be infringed by our generic product candidate.
On February 18, 2005, GlaxoSmithKline filed a lawsuit against us in the United States District
Court for the District of Delaware, alleging infringement of the patent on Imitrex®. Pursuant to
the Hatch-Waxman Act, the FDA is stayed from approving our ANDA until the earlier of a final,
non-appealed or non-appealable court decision finding the patent invalid, unenforceable or not
infringed or the expiration of the 30 months. The 30 month stay began running when GlaxoSmithKline
filed suit in federal court alleging patent infringement of their Orange Book-listed patent. Often
more than one company will file an ANDA that includes a Paragraph IV certification. However, the
Hatch-Waxman Act provides that such subsequent ANDA applications will not be approved until 180
days after the earlier of (1) the date of the first commercial marketing of the first-filed ANDA
applicants generic drug or (2) the date of a decision of a court in an action holding the relevant
patent invalid, unenforceable, or not infringed. Thus, the Hatch-Waxman Act effectively grants the
first-filed ANDA holder 180 days of marketing exclusivity for the generic product. We believe that
our ANDA was the first filed ANDA containing a Paragraph IV certification in connection with
sumatriptan succinate injection 6mg/0.5mL. If the patent is found to be infringed by the filing of
our ANDA, GlaxoSmithKline could seek an injunction to block the launch of our generic product until
the patent expires.
While it is not possible to determine with any degree of certainty the ultimate outcome of the
foregoing legal proceedings, we believe that we have substantial and meritorious basis with respect
to our Paragraph IV challenge of GlaxoSmithKline patent for sumatriptan succinate injection
6mg/0.5mL.
Other
We are sometimes involved in matters of litigation that we consider ordinary routine
litigation incidental to our business. We are not aware of any pending litigation matters that will
materially affect our financial statements.
ITEM 2. Unregistered Sales
of Equity Securities and Use of Proceeds
None
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Submission of Matters to a Vote of Security Holders
None
40
ITEM 5. Other Information (not previously reported in a Form 8-K)
None.
ITEM 6. Exhibits
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.
41
EXHIBIT INDEX
our ability to successfully develop, obtain regulatory approvals for and market our products;
our ability to generate and maintain sufficient cash resources to increase investment in our business;
our ability to identify new product candidates;
the timing or results of pending or future clinical trials;
actions by the FDA and other regulatory agencies;
demand and market acceptance for our approved products; and
the effect of changing economic conditions.
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Funding for satraplatin clinical trials is being borne entirely by our co-development
partner GPC Biotech. We are funding the Phase 2 clinical trials of EOquin, elsamitrucin and
SPI-153; and plan to fund the development, including clinical trials, of RenaZorband
SPI-1620.
We have nine drug products for which we have ANDAs pending with the FDA: fluconazole
tablets, injectable carboplatin and sumatriptan succinate, and six other drug products.
We expect to receive approval by the FDA of our ANDAs for carboplatin and fluconazole
in 2005.
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Satraplatin
:
The costs of conducting clinical trials are being borne entirely
by our co-development partner GPC Biotech. While we have licensed the development of
satraplatin to GPC Biotech, we are not obligated to reimburse GPC Biotech for development
costs they incur or to refund any license or milestone payments we receive.
EOquin
:
Excluding indirect costs
described earlier, we spent approximately $400,000 on the development
of EOquin in the quarter ended March 31, 2005. Estimated expenditures for the next
twelve months are subject to considerable uncertainty, and are largely dependent on the
analysis of Phase 2 clinical trial data that is expected to be available in the first half
of 2005. We anticipate that over the next twelve months we may incur development costs
ranging between approximately $1.5 million and $3 million.
Elsamitrucin
:
Excluding indirect costs
described earlier, we spent approximately $200,000 on the development
of Elsamitrucin in the quarter ended March 31, 2005. Estimated expenditures for the next
twelve months are subject to considerable uncertainty, and are largely dependent on the
completion of enrollment in the Phase 2 clinical trial and positive results. We anticipate
that over the next twelve months we may incur development costs ranging between
approximately $1.5 million and $3 million.
SPI-153
:
Excluding indirect costs
described earlier, we spent approximately $1.1 million on the development of SPI-153 in the quarter ended
March 31, 2005. Estimated
expenditures for the next twelve months are subject to considerable uncertainty. Depending
on the indications we develop the product for, we may incur development costs ranging
between approximately $2 million and $5 million over the next twelve months.
RenaZorb
: We paid Altair Nanotechnologies, Inc. an upfront payment of 100,000
restricted shares of Spectrum common stock and made an equity investment of $200,000 for
38,314 shares of Altair common stock for an exclusive worldwide license to develop and
commercialize, for all human therapeutic and diagnostic uses, RenaZorb, two
second-generation lanthanum-based phosphate binding agents. As of the date of this report
we are unable to reliably estimate the development costs for RenaZorb because we only
recently acquired the rights to the compound and we are still in the early stages of
planning for future development. However, upon successful achievement of one of the
development milestones, which is anticipated to occur in 2005, we will be obligated to
issue 100,000 restricted shares of our common stock to Altair.
SPI-1620
:
We paid Chicago Labs an upfront fee of $100,000 for an exclusive
worldwide license to develop and commercialize SPI-1620, an endothelinB agonist, which we
believe may selectively dilate tumor blood
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vessels and thereby selectively increase the delivery of anti-cancer drugs to cancer tissue,
for the prevention and treatment of cancer. As of the date of this report we are unable to
reliably estimate the development costs for SPI-1620 because we only recently acquired the
rights to the compound and we are still in the early stages of planning for future
development.
In addition to the foregoing drug product candidates, we continually evaluate
proprietary products for acquisition. If we are successful in licensing additional
products, our research and development expenditures would increase.
While we are contingently obligated to make cash milestone payments aggregating
approximately $45 million as of March 31, 2005, under our licensing agreements, given the
unpredictability of the results to be derived from those trials, we believe that it is
unlikely that any material cash milestone payment obligation will be triggered in the next
12 months. If we reach a milestone, it will likely occur prior to revenues being generated
from the related compound. However, in connection with the milestone obligations related to
one of our drug product candidates, satraplatin, each of our contingent future cash payment
obligations is generally matched by a corresponding, greater cash payment milestone
obligation of GPC Biotech to us.
Generic drugs
:
During the three months
ended March 31, 2005, we have spent approximately $500,000 on the development of generic drugs, including costs for products that we
anticipate filing ANDAs for in the future. Over the next twelve months we expect to incur
development costs ranging between $2 million and $3 million. We do not receive any funding
from third parties for research and development we conduct for generic products, nor do we
pay our generic alliance partners for any research and development they incur in the
development of ANDAs for regulatory approval.
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Less than
After
Total
1 Year
1-3 Years
3-5 Years
5 Years
$
$
$
$
$
$
1,976
$
421
$
931
$
624
$
$
7,101
$
6,211
$
890
$
$
$
44,900
$
$
6,650
$
5,250
$
33,000
$
53,977
$
6,632
$
8,471
$
5,874
$
33,000
(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 significant contingent obligations are described below under Employment
Agreements.
(2)
As of March 31, 2005, we had no capital lease obligations.
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(3)
The operating lease obligations are substantially related to the facility lease for our
corporate office, which extends through June 2009.
(4)
Purchase Obligations represent the amount of open purchase orders and contractual commitments
to vendors, for products and services that have not been delivered, or rendered, as of March
31, 2005.
(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 milestone obligations
as of March 31, 2005, 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 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.
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Drug Candidate
Target Indication
Development Status
Hormone Refractory Prostate Cancer
Late Phase 3 clinical trial
Refractory Superficial Bladder Cancer
Late Phase 2 clinical trial
Refractory non-Hodgkins Lymphoma
Phase 2 clinical trial
Hormone Dependent Prostate Cancer
Phase 2 clinical trial
Benign Prostatic Hypertrophy
Phase 2 clinical trial
Non-small cell lung cancer
Phase 1/2 clinical trial
Radiation Sensitizer
Pre-clinical
End-stage Renal Disease, Chronic Kidney Disease
Pre-clinical
Adjunct to Chemotherapy
Pre-clinical
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pursuing new patents for existing products which may be granted just before the
expiration of one patent, which could extend patent protection for a number of years or
otherwise delay the launch of generics;
using the citizen petition process, a process by which any person can submit a petition
to the Commissioner of the FDA to issue, amend or revoke a regulation or order or take or
refrain from taking any other administrative action, to request amendments to FDA
standards;
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seeking changes to the United States Pharmacopoeia, an organization which publishes
industry recognized compendia of drug standards; and
attaching patent extension amendments to non-related federal legislation.
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fines;
changes in advertising;
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revocation or suspension of regulatory approvals of products;
product recalls or seizures;
delays, interruption, or suspension of product distribution, marketing and sale;
civil or criminal sanctions; and
refusals to approve new products.
incurring substantial expenses, including fines, penalties, legal fees and costs to
comply with the FDAs requirements;
changes in the methods of marketing and selling products;
taking FDA-mandated corrective action, which may include placing advertisements or
sending letters to physicians, rescinding previous advertisements or promotions; and
disruption in the distribution of products and loss of sales until compliance with the
FDAs position is obtained.
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the ability of our board of directors to amend our bylaws without stockholder approval;
the inability of stockholders to call special meetings;
the ability of members of the board of directors to fill vacancies on the board of directors;
the inability of stockholders to act by written consent, unless such consent is unanimous;
the establishment of advance notice requirements for nomination for election to our
board of directors or for proposing matters that can be acted on by stockholders at
stockholder meetings.
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Exhibit No.
Description
License Agreement by and between the Registrant, Altair Nanomaterials, Inc.
and Nanotechnologies, Inc. dated as of January 28, 2005. (Filed as Exhibit
10.1 to Form 8-K, as filed with the Securities and Exchange Commission on
February 3, 2005, and incorporated herein by reference.)
License Agreement by and between the Registrant and Chicago Labs, Inc. dated
February 18, 2005. (Filed as Exhibit 10.1 to Form 8-K with the Securities
and Exchange Commission on February 25, 2005, and incorporated herein by
reference.)
Summary of Director Compensation. (Filed as Exhibit 10.42 to Form 10-K, as filed with
the Securities and Exchange Commission on March 15, 2005, and incorporated herein by
reference.)
Distribution and Supply Agreement by and between the Registrant and Cura
Pharmaceutical Co. Inc. dated as of April 13, 2005. (Filed as Exhibit 10.1
to Form 8-K, as filed with the Securities and Exchange Commission on April
19, 2005, and incorporated herein by reference.)
Form of Non-Employee Director Stock Option Agreement under the 2003 Amended
and Restated Incentive Award Plan.
Certification of Chief Executive Officer, pursuant to Rule 13a-14 promulgated
under the Exchange Act, as created by Section 302 of the Sarbanes-Oxley Act
of 2002.
Certification of Vice President Finance, pursuant to Rule 13a-14 promulgated
under
the Exchange Act, as created by Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350,
as created by Section 906 of the Sarbanes-Oxley Act of 2002.
Certification of Vice President Finance, 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.
SPECTRUM PHARMACEUTICALS, INC.
Date: May 10, 2005
By:
/s/ Shyam K. Kumaria
Shyam K. Kumaria, Vice President, Finance
(Authorized Signatory and Principal Financial Officer)
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Exhibit No.
Description
License Agreement by and between the Registrant, Altair Nanomaterials, Inc. and
Nanotechnologies, Inc. dated as of January 28, 2005. (Filed as Exhibit 10.1 to Form 8-K,
as filed with the Securities and Exchange Commission on February 3, 2005, and incorporated
herein by reference.)
License Agreement by and between the Registrant and Chicago Labs, Inc. dated February 18,
2005. (Filed as Exhibit 10.1 to Form 8-K with the Securities and Exchange Commission on
February 25, 2005, and incorporated herein by reference.)
Summary of Director Compensation. (Filed as Exhibit 10.42 to Form 10-K, as filed with
the Securities and Exchange Commission on March 15, 2005, and incorporated herein by
reference.)
Distribution and Supply Agreement by and between the Registrant and Cura Pharmaceutical
Co. Inc. dated as of April 13, 2005. (Filed as Exhibit 10.1 to Form 8-K, as filed with
the Securities and Exchange Commission on April 19, 2005, and incorporated herein by
reference.)
Form of Non-Employee Director Stock Option Agreement under the 2003 Amended and Restated
Incentive Award Plan.
Certification of Chief Executive Officer, pursuant to Rule 13a-14 promulgated under the
Exchange Act, as created by Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Vice President Finance, pursuant to Rule 13a-14 promulgated under the
Exchange Act, as created by Section 302 of the Sarbanes-Oxley Act of 2002.
Certification of Chief Executive Officer, pursuant to 18 U.S.C. Section 1350, as created by
Section 906 of the Sarbanes-Oxley Act of 2002.
Certification of Vice President Finance, 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.
EXHIBIT 10.5
SPECTRUM PHARMACEUTICALS, INC.
NON-EMPLOYEE DIRECTOR
STOCK OPTION AGREEMENT
(THE "AGREEMENT")
TO: ___________________ (THE "OPTIONEE")
WE ARE PLEASED TO INFORM YOU THAT YOU HAVE BEEN SELECTED BY THE BOARD OF DIRECTORS OF SPECTRUM PHARMACEUTICALS, INC., A DELAWARE CORPORATION, (THE "COMPANY") TO RECEIVE A STOCK OPTION (THE "OPTION") FOR THE PURCHASE OF __________ SHARES (THE "SHARES") OF THE COMPANY'S COMMON STOCK, $.001 PAR VALUE PER SHARE (THE "COMMON STOCK"), AT A PURCHASE PRICE OF $ ___________ PER SHARE (THE "EXERCISE PRICE").
The Option is intended to be an incentive stock option as described in
Section 422 of the Internal Revenue Code of 1986, as amended (the "Code"), but
the Company does not represent or warrant that the Option qualifies as such. If
this Option fails in whole or in part to qualify as an incentive stock option,
then this Option shall to that extent constitute a nonqualified stock option.
The terms of the Option are set forth in this Agreement and the Company's 2003 Amended and Restated Incentive Award Plan (the "Plan"), a copy of which is attached. This Agreement is limited by and subject to the express terms and provisions of the Plan. Unless otherwise provided in this Agreement, defined terms will have the meaning given to such terms in the Plan.
1. DATE OF GRANT. The Option is granted effective as of ___________,
(the "Grant Date")
2. VESTING OF OPTION. The right to exercise this option shall vest in increments as follows: ____________________________________________________.
Notwithstanding the foregoing, this Option shall become immediately vested and exercisable in full immediately prior to the consummation of a Change in Control.
Except as otherwise may be provided by the Committee, no portion of the Option that is not vested and exercisable at date of termination of Optionee's Continuous Service shall thereafter become vested and exercisable.
3. TERM OF OPTION. Optionee's right to exercise the vested portion of this Option shall terminate upon the first to occur of the following:
(a) the expiration of ten (10) years from the date of this Agreement;
(b) the expiration of five years from the date of termination of Optionee's Continuous Service if such termination occurs for any reason other than (i) removal from office by action of the Board of Directors or the stockholders of the Company, or (ii) a failure to be elected as a director by the stockholders at any meeting of the stockholders at which the Optionee was a candidate for election to the Board of Directors, or (iii) the Optionee resigning from the Board of Directors prior to the expiration of their term of office; or
(c) the expiration of three months from the date of termination of Optionee's Continuous Service if such termination is due to (i) removal from office by action of the Board of Directors or the stockholders of the Company, or (ii) a failure to be elected as a director by the stockholders at any meeting of the stockholders at which the Optionee was a candidate for election to the Board of Directors, or (iii) the Optionee resigning from the Board of Directors prior to the expiration of their term of office.
4. EXERCISE OF OPTION. On or after the vesting of any portion of this Option in accordance with Section 2 above, and until termination of this Option in accordance with Section 3 above, the portion of this Option which has vested may be exercised in whole or in part by the Optionee (or, after his or her death, by the Optionee's Successor, as provided in Section 5 below) upon delivery of the following to the Company at its principal executive offices:
(a) a written notice of exercise which identifies this Agreement and states the number of Shares then being purchased. In the event the Option or portion shall be exercised by any person or persons other than the Optionee, as permitted pursuant to the terms of this Agreement and the Plan, appropriate proof of the right of such person or persons to exercise the Option must be submitted;
(b) payment of the Exercise Price by (i) cash, (ii) check, (iii) through the delivery of a notice that the Optionee has placed a market sell order with a broker with respect to the shares of Common Stock then issuable upon exercise of the Option, and the broker pays a sufficient portion of the net proceeds of the sale to the Company in satisfaction of the Option exercise price upon settlement of such sale, or (iv) such other form of lawful consideration as the Committee may approve from time to time consistent with the terms of the Plan; and
(c) payment in satisfaction of the Company's withholding obligations under federal, state or other applicable tax laws with respect to the taxable income, if any, recognized by the Optionee in connection with the exercise of this Option (such payment may be in the form of cash, check, the broker exercise procedures described in (b)(iii) above, deductions or withholding from Optionee's wages, bonus or other compensation payable to Optionee, or, with the consent of the Committee, by the withholding of Shares issuable upon exercise of this Option or the delivery of Shares owned by the Optionee in accordance with the Plan, provided such arrangements satisfy the requirements of applicable tax laws; provided, however, that if such payment is in the form of shares of Common Stock withheld from exercise or delivered by the Optionee, the Fair Market Value of such shares shall not exceed the sums necessary to pay the tax withholding based on the minimum statutory withholding rates for federal and state tax purposes, including payroll taxes, that are applicable to such supplemental taxable income.
Each partial exercise shall be for not less than one hundred (100) shares (or the minimum installment set forth in Section 2, if a smaller number of shares) and shall be for whole shares only.
The Committee may, in its absolute discretion, require such representations, documents and agreements from Optionee and take whatever additional actions it deems appropriate to insure compliance with the
Securities Act of 1933, as amended (the "Securities Act") and any other federal or state securities laws or regulations.
5. NO ASSIGNMENT OR TRANSFER. Except as permitted by the Committee consistent with the terms of the Plan, the rights of the Optionee under this Agreement may not be assigned, transferred or otherwise disposed of by an Optionee other than by will or by the laws of descent and distribution, and the Option may be exercised during the lifetime of the Optionee only by such Optionee. Any attempt to sell, pledge, assign, encumber, hypothecate, transfer or dispose of this Option in contravention of this Agreement or the Plan shall be void and shall have no effect. In the event of the Optionee's death, and provided Optionee's rights hereunder shall have vested pursuant to Section 2 hereof, Optionee's legal representative, his or her legatee, or the person who acquired the right to exercise this Option by reason of the death of the Optionee (individually, a "Successor") shall succeed to the Optionee's rights and obligations under this Agreement. After the death of the Optionee, only a Successor may exercise this Option.
6. REPRESENTATIONS AND WARRANTIES OF OPTIONEE.
(a) Optionee acknowledges that the Company may issue Shares upon the exercise of the Option without registering such Shares under the Securities Act, on the basis of certain exemptions from such registration requirement. Accordingly, Optionee agrees that his or her exercise of the Option may be expressly conditioned upon his or her delivery to the Company of an investment certificate including such representations and undertakings as the Company may reasonably require in order to assure the availability of such exemptions, including a representation that Optionee is acquiring the Shares for investment and not with a present intention of selling or otherwise disposing thereof and an agreement by Optionee that the certificates evidencing the Shares may bear a legend indicating such non-registration under the Securities Act and the resulting restrictions on transfer. Optionee acknowledges that, because Shares received upon exercise of an Option may be unregistered, Optionee may be required to hold the Shares indefinitely unless they are subsequently registered for resale under the Securities Act or an exemption from such registration is available.
(b) Optionee acknowledges receipt of a copy of the Plan and understands that all rights and obligations connected with this Option are set forth in the Agreement and in the Plan.
(c) Optionee hereby acknowledges that federal securities laws and the securities laws of the state in which he or she resides may require the placement of certain restrictive legends upon the Shares issued upon exercise of this Option, and Optionee hereby consents to the placing of any such legends upon certificates evidencing the Shares as the Company may deem necessary or advisable.
7. NOTICE OF DISPOSITION OF CERTAIN SHARES. Optionee agrees to give the Company prompt notice of any disposition or sale of any Shares acquired upon exercise of an incentive stock option, if such disposition occurs within (i) two(2) years following the Grant Date or (ii) one(1) year following the transfer of such Shares to Optionee.
8. ADJUSTMENTS UPON CHANGES IN CAPITAL STRUCTURE.
(a) In the event of any stock dividend, stock split, combination or exchange of shares, merger, consolidation, spin-off, recapitalization or other distribution (other than normal cash dividends) of Company assets to stockholders, or any other change affecting the share of stock or the share price of the stock of the Company, the Committee shall make such proportionate adjustments, if any, as the Committee in its discretion may deem appropriate to reflect such change with respect to (i) the terms and conditions of this Option and (ii) the grant or exercise price per share for this Option.
(b) In the event of any transaction or event described in Section
8(a), the Committee, in its sole discretion, and on such terms and conditions as
it deems appropriate, may take one or more of the following actions: (i) provide
for the purchase or exchange of this Option for an amount of cash equal to the
amount that could have been obtained upon the exercise of this Option or
realization of the Optionee's rights had such Option been currently exercisable
or payable or fully vested, or the replacement of such Option with other rights
or property selected by the Committee in its sole discretion; (ii) provide that
this Option shall be exercisable as to all shares covered hereby,
notwithstanding anything to the contrary in the Plan or the provisions of this
Agreement, (iii) provide that this Option be assumed by the successor or
survivor corporation or entity, or a parent or subsidiary thereof, or be
substituted for by similar options, rights or awards covering the stock of the
successor or survivor corporation or entity, or a parent or subsidiary thereof,
with appropriate adjustments as to the number and kind of shares and prices;
(iv) provide for adjustments in the number and kind of shares or other
securities or property subject to the Option and/or adjustments in the terms and
conditions of the Option (including the Exercise Prices); (v) provide that
immediately upon the consummation of such event, this Option shall not be
exercisable and shall terminate, provided, that for a specified period of time
prior to such event, such Option shall be exercisable as to all shares of stock
covered hereby, notwithstanding anything to the contrary in the Plan or the
provisions of this Agreement.
9. CONSIDERATION; EMPLOYMENT AT WILL. In consideration of the granting of this Option by the Company, the Optionee (i) agrees to render faithful and efficient services to the Company or Subsidiary, with such duties and responsibilities as the Company or Subsidiary shall from time to time prescribe, for a period of at least one (1) year from the Grant Date, (ii) agrees not disclose or use, directly or indirectly, any proprietary or confidential information concerning the Company or any Subsidiary so long as such information is proprietary and/or confidential, except any disclosure or use that is for the benefit of the Company or such Subsidiary and incidental to the Optionee's employment or service with the Company, and (iii) agrees to abide by all of the terms and conditions of this Agreement and the Plan. Neither the granting of this Option nor the exercise hereof shall be construed as granting to the Optionee any right with respect to continuance of employment by the Company or any Subsidiary. The right of the Company or any Subsidiary to terminate at will the Optionee's employment or service at any time (whether by dismissal, discharge or otherwise), with or without cause, is specifically reserved.
10. RIGHTS AS A SHAREHOLDER. The Optionee (or Successor) shall have no rights as a shareholder with respect to any Shares covered by this Option until the date of the issuance of a stock certificate or certificates for such Shares (or other delivery of the Shares) to him or her, notwithstanding the exercise of this Option. The Company shall not be required to issue or deliver any certificate or certificates for Shares purchased upon the exercise of the Option or portion thereof prior to fulfillment of all of the following conditions:
(a) The admission of such Shares to listing on all stock exchanges on which such class of stock is then listed;
(b) The completion of any registration or other qualification of such Shares under any state or federal law or under rulings or regulations of the Securities and Exchange Commission or of any other governmental regulatory body, which the Committee shall, in its absolute discretion, deem necessary or advisable;
(c) The obtaining of any approval or other clearance from any state or federal governmental agency which the Committee shall, in its absolute discretion, determine to be necessary or advisable;
(d) The receipt by the Company (or Subsidiary employer) of full payment for such Shares, including payment of all amounts which, under federal, state or local tax law, it is required to withhold upon exercise of the Option; and
(e) The lapse of such reasonable period of time following the exercise of the Option as the Committee may from time to time establish for reasons of administrative convenience.
11. SPECIAL TAX CONSEQUENCES. The Optionee acknowledges that, to the extent that the aggregate fair market value of stock with respect to which "incentive stock options" (within the meaning of Section 422 of the Code, but without regard to Section 422(d) of the Code) granted hereby and all other incentive stock options granted by the Company or any Subsidiary to Optionee that are exercisable for the first time by the Optionee during any calendar year exceeds $100,000, such options shall be treated for all purposes as not qualifying under Section 422 of the Code and therefore shall be subject to taxation as non-qualified options. The Optionee further acknowledges that the rules set forth in the preceding sentence shall be applied by taking options into account in the order in which they were granted. For purposes of these rules, the fair market value of stock shall be determined as of the time the option with respect to such option is granted.
12. "MARKET STAND-OFF" AGREEMENT. Optionee agrees that, if requested by the Company of the managing underwriter of any proposed public offering of the Company's securities, Optionee will not sell or otherwise transfer or dispose of any shares held by Optionee without the prior written consent of the Company or such underwriter, as the case may be, during such period of time, not to exceed 180 days following the effective date of the registration statement filed by the Company with respect to such offering, as the Company or the underwriter may specify.
13. INTERPRETATION. This Option is granted pursuant to the terms of the Plan, and shall in all respects be interpreted in accordance therewith. The Committee shall have the power to interpret the Plan and this Agreement and to adopt such rules for the administration, interpretation and application of the Plan as are consistent therewith and to interpret or revoke any such rules. Any action, decision, interpretation or determination by the Committee shall be final, binding and conclusive on the Company and the Optionee. No member of the Committee shall be personally liable for any action, determination or interpretation made in good faith with respect to the Plan or the Option.
14. NOTICES. Any notice, demand or request required or permitted to be given under this Agreement shall be in writing and shall be deemed given when delivered personally or three days after being deposited in the United States mail, as certified or registered mail, with postage prepaid, and addressed, if to the Company, at its principal place of business, Attention: General Counsel and Chief Financial Officer, and if to the Optionee, at his or her most recent address as shown in the employment or stock records of the Company.
15. GOVERNING LAW. The validity, construction, interpretation, and effect of this Option shall be governed by and determined in accordance with the laws of the State of Delaware.
16. SEVERABILITY. Should any provision or portions of this Agreement be held to be unenforceable or invalid for any reason, the remaining provisions and portions of this Agreement shall be unaffected by such holding.
17. COUNTERPARTS. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall be deemed one instrument.
18. CONFORMITY TO APPLICABLE LAWS. The Optionee acknowledges that the Plan and this Agreement are intended to conform to the extent necessary with all provisions of the Securities Act and the Securities Exchange Act of 1934, as amended, and any and all regulations and rules promulgated by the Securities and Exchange Commission thereunder, including without limitation Rule 16b-3, and to all applicable state securities laws. Notwithstanding anything herein to the contrary, the Plan shall be administered, and the Option is granted and may be exercised, only in such a manner as to conform to such laws, rules and regulations. To the extent permitted by applicable law, the Plan and this Agreement shall be deemed amended to the extent necessary to conform to such laws, rules and regulations.
SIGNATURE PAGE FOLLOWS
IN WITNESS WHEREOF, the Company has caused this option to be executed by its duly authorized officer.
SPECTRUM PHARMACEUTIALS, INC.
PARTICIPANT'S ACCEPTANCE
The undersigned hereby accepts the foregoing option and agrees to the terms and conditions thereof. The undersigned hereby acknowledges receipt of a copy of the Company's 2003 Amended and Restated Incentive Award Plan.
PARTICIPANT DATED: ------------------------------- ------------------------------------- SIGNATURE |
By his or her signature below, the spouse of the Optionee, if Optionee is legally married as of the date of his or her execution of this Agreement, acknowledges that he or she has read this Agreement and the Plan and is familiar with the terms and provisions thereof, and agrees to be bound by all the terms and conditions of this Agreement and the Plan.
DATED: ------------------------------- ------------------------------------- SPOUSE'S SIGNATURE ------------------------------------- PRINTED NAME |
OR
By his or her signature below, the Optionee represents that he or she is not legally married as of the date of execution of this Agreement.
PARTICIPANT DATED: ------------------------------- ------------------------------------- SIGNATURE |
EXHIBIT 31.1
Certification of Chief Executive Officer
I, Rajesh C. Shrotriya, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Spectrum Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(F) and
15d-15(f)), for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) designed such internal controls over financial reporting, or caused such internal controls
financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external
purposes in accordances with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth
fiscal quarter in the case of an annual report) that has materially affected, or is reasonably
likely to materially affect, the registrants internal control over financial reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the registrants
ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Date: May 10, 2005
/s/ RAJESH C. SHROTRIYA
Rajesh C. Shrotriya
Chairman, Chief Executive Officer and President
EXHIBIT 31.2
Certification of Vice President, Finance
I, Shyam K. Kumaria, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Spectrum Pharmaceuticals, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or
omit to state a material fact necessary to make the statements made, in light of the circumstances
under which such statements were made, not misleading with respect to the period covered by this
report;
3. Based on my knowledge, the financial statements, and other financial information included in
this report, fairly present in all material respects the financial condition, results of operations
and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrants other certifying officer and I are responsible for establishing and maintaining
disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and
internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(F) and
15d-15(f)), for the registrant and have:
(a) designed such disclosure controls and procedures, or caused such disclosure controls and
procedures to be designed under our supervision, to ensure that material information relating to
the registrant, including its consolidated subsidiaries, is made known to us by others within those
entities, particularly during the period in which this report is being prepared;
(b) designed such internal controls over financial reporting, or caused such internal controls
financial reporting to be designed under our supervision, to provide reasonable assurance regarding
the reliability of financial reporting and the preparation of financial statements for external
purposes in accordances with generally accepted accounting principles;
(c) evaluated the effectiveness of the registrants disclosure controls and procedures and
presented in this report our conclusions about the effectiveness of the disclosure controls and
procedures, as of the end of the period covered by this report based on such evaluation; and
(d) disclosed in this report any change in the registrants internal control over financial
reporting that occurred during the registrants most recent fiscal quarter (the registrants
fourth fiscal quarter in the case of an annual report) that has materially affected, or is
reasonably likely to materially affect, the registrants internal control over financial
reporting; and
5. The registrants other certifying officer and I have disclosed, based on our most recent
evaluation of internal control over financial reporting, to the registrants auditors and the audit
committee of the registrants board of directors (or persons performing the equivalent functions):
a) all significant deficiencies and material weaknesses in the design or operation of internal
control over financial reporting which are reasonably likely to adversely affect the
registrants ability to record, process, summarize and report financial information; and
b) any fraud, whether or not material, that involves management or other employees who have a
significant role in the registrants internal control over financial reporting.
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
Date: May 10, 2005
/s/ SHYAM K. KUMARIA
Shyam K. Kumaria
Vice President, Finance
EXHIBIT 32.1
Certification of Chief Executive Officer
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Spectrum Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period
ended March 31, 2005 (the Report) fully complies with the requirements of Section 13(a) or
Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Dated: May 10, 2005
/s/ RAJESH C. SHROTRIYA
Rajesh C. Shrotriya
Chairman, Chief Executive Officer and President
EXHIBIT 32.2
Certification of Vice President, Finance
Pursuant to 18 U.S.C. § 1350, as created by Section 906 of the Sarbanes-Oxley Act of 2002, the
undersigned officer of Spectrum Pharmaceuticals, Inc. (the Company) hereby certifies, to such
officers knowledge, that:
(i) the accompanying Quarterly Report on Form 10-Q of the Company for the quarterly period
ended March 31, 2005 (the Report) fully complies with the requirements of Section 13(a) or
Section 15(d), as applicable, of the Securities Exchange Act of 1934, as amended; and
(ii) the information contained in the Report fairly presents, in all material respects, the
financial condition and results of operations of the Company.
Dated: May 10, 2005
/s/ SHYAM K. KUMARIA
Shyam K. Kumaria
Vice President, Finance