UNITED STATES
FORM 10-Q
(Mark One)
[X] | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |
For the quarterly period ended March 31, 2003 |
OR
[ ] | 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 [X] | No [ ] |
Indicate by check mark whether the Registrant is an accelerated filer (as defined in Rule 12B-2 of the Exchange Act).
Yes [ ] | No [X] |
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, 2003 | |||
Common Stock, $.001 par value | 3,108,100 |
SPECTRUM PHARMACEUTICALS, INC.
TABLE OF CONTENTS
Page No. | |||||
PART I. FINANCIAL INFORMATION |
|||||
ITEM 1. Financial Statements |
|||||
Statement Regarding Financial Information |
3 | ||||
Condensed Consolidated Balance Sheets as of March 31, 2003 and
December 31, 2002 (unaudited) |
4 | ||||
Condensed Consolidated Statements of Operations for the three-month periods
ended March 31, 2003 and 2002 (unaudited) |
5 | ||||
Condensed Consolidated Statements of Cash Flows for the three-month periods
ended March 31, 2003 and 2002 (unaudited) |
6 | ||||
Notes to Condensed Consolidated Financial Statements (unaudited) |
7 | ||||
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of
Operations |
13 | ||||
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk |
21 | ||||
ITEM 4. Controls and Procedures |
21 | ||||
PART II. OTHER INFORMATION |
22 | ||||
ITEM 1. Legal Proceedings |
22 | ||||
ITEM 2. Changes in Securities and Use of Proceeds |
22 | ||||
ITEM 3. Defaults Upon Senior Securities |
22 | ||||
ITEM 4. Submission of Matters to a Vote of Security Holders |
22 | ||||
ITEM 5. Other Information (not previously reported in a Form 8-K) |
22 | ||||
ITEM 6. Exhibits and Reports on Form 8-K |
23 | ||||
SIGNATURES |
23 |
SPECTRUM PHARMACEUTICALS, INC.
FORM 10-Q
For the Three-Month Period Ended March 31, 2003
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
Statement Regarding Financial Information
The condensed consolidated financial statements of Spectrum Pharmaceuticals, Inc. (the Company) 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, the Company believes that the disclosures are adequate to make the information presented not misleading. The Company recommends that you read the consolidated financial statements included herein in conjunction with the audited consolidated financial statements and notes thereto included in the Companys Amendment Number Two to the Annual Report on Form 10-K for the fiscal year ended December 31, 2002, filed with the Securities and Exchange Commission.
3
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Condensed Consolidated Balance Sheets
(Unaudited)
March 31, | December 31, | |||||||||||
2003 | 2002 | |||||||||||
Assets |
||||||||||||
Current Assets: |
||||||||||||
Cash and cash equivalents |
$ | 576,509 | $ | 1,511,942 | ||||||||
Marketable securities and short-term investments |
66,268 | 66,396 | ||||||||||
Other receivables |
87,928 | 203,558 | ||||||||||
Property and equipment, held for sale |
604,810 | 619,000 | ||||||||||
Prepaid expenses and refundable deposits |
107,554 | 170,214 | ||||||||||
Total current assets |
1,443,069 | 2,571,110 | ||||||||||
Property and Equipment, at cost: |
||||||||||||
Equipment |
1,173,137 | 1,177,828 | ||||||||||
Leasehold improvements |
509,032 | 509,032 | ||||||||||
Accumulated depreciation and amortization |
(964,082 | ) | (884,794 | ) | ||||||||
Property and equipment, net |
718,087 | 802,066 | ||||||||||
Other Assets deposits |
79,944 | 79,944 | ||||||||||
Total assets |
$ | 2,241,100 | $ | 3,453,120 | ||||||||
Liabilities and Stockholders Equity (Deficit) |
||||||||||||
Current Liabilities: |
||||||||||||
Accounts payable and accrued expenses |
$ | 2,167,153 | $ | 2,013,247 | ||||||||
Accrued payroll and related taxes |
126,497 | 201,847 | ||||||||||
Current portion of capital lease obligations |
272,454 | 306,597 | ||||||||||
Total current liabilities |
2,566,104 | 2,521,691 | ||||||||||
Capital lease obligations, net of current portion |
104,667 | 157,581 | ||||||||||
Other non-current liabilities |
121,951 | 101,496 | ||||||||||
Commitments and Contingencies (Note 4) |
||||||||||||
Stockholders Equity: |
||||||||||||
Preferred stock, par value $0.001 per share, 5,000,000 shares authorized: |
||||||||||||
None issued or outstanding at March 31, 2003 and December 31, 2002 |
| | ||||||||||
Common stock, par value $0.001 per share, 50,000,000 shares authorized: |
||||||||||||
Issued and outstanding, 2,948,241 and 2,726,019 shares at March 31, 2003
and December 31, 2002, respectively |
2,948 | 2,726 | ||||||||||
Additional paid-in capital |
144,295,691 | 143,831,315 | ||||||||||
Deferred compensation |
(47,361 | ) | (55,730 | ) | ||||||||
Accumulated other comprehensive income |
5,334 | 5,724 | ||||||||||
Accumulated deficit |
(144,808,234 | ) | (143,111,683 | ) | ||||||||
Total stockholders equity (deficit) |
(551,622 | ) | 672,352 | |||||||||
Total liabilities and stockholders equity (deficit) |
$ | 2,241,100 | $ | 3,453,120 | ||||||||
The accompanying notes are an integral part of these
condensed consolidated balance sheets.
4
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Condensed Consolidated Statements of Operations
(Unaudited)
Three-Months | Three-Months | ||||||||
Ended | Ended | ||||||||
March 31, 2003 | March 31, 2002 | ||||||||
Revenues |
$ | | $ | 20,001 | |||||
Operating expenses: |
|||||||||
Research and development |
852,784 | 4,924,123 | |||||||
General and administrative |
845,258 | 1,478,511 | |||||||
Total operating expenses |
1,698,042 | 6,402,634 | |||||||
Loss from operations |
(1,698,042 | ) | (6,382,633 | ) | |||||
Other income, net |
1,490 | 77,169 | |||||||
Net loss |
$ | (1,696,552 | ) | $ | (6,305,464 | ) | |||
Basic and diluted net loss per share |
$ | (0.58 | ) | $ | (6.50 | ) | |||
Basic and diluted weighted average common shares outstanding |
2,908,735 | 970,071 | |||||||
The accompanying notes are an integral part of these
condensed consolidated statements.
5
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Condensed Consolidated Statements of Cash Flows
(Unaudited)
Three-Months | Three-Months | |||||||||||
Ended | Ended | |||||||||||
March 31, 2003 | March 31, 2002 | |||||||||||
Cash Flows From Operating Activities: |
||||||||||||
Net loss |
$ | (1,696,552 | ) | $ | (6,305,464 | ) | ||||||
Adjustments to reconcile net loss to net cash used in
operating activities: |
||||||||||||
Depreciation and amortization |
80,555 | 244,974 | ||||||||||
Amortization of employee stock option compensation |
6,975 | 191,756 | ||||||||||
Gain on sale of assets |
(14,850 | ) | | |||||||||
Changes in operating assets and liabilities: |
||||||||||||
Decrease in other receivables, prepaid
expenses and refundable deposits |
178,290 | 361,238 | ||||||||||
Increase (decrease) in accounts payable and
accrued expenses |
153,907 | (1,071,650 | ) | |||||||||
Increase (decrease) in accrued payroll and related taxes |
(75,350 | ) | 32,852 | |||||||||
Increase (decrease) in other non-current liabilities |
20,456 | (31,551 | ) | |||||||||
Net cash used in operating activities |
(1,346,569 | ) | (6,577,845 | ) | ||||||||
Cash Flows From Investing Activities: |
||||||||||||
Purchases of property and equipment |
| (45,840 | ) | |||||||||
Redemption of marketable securities and
short-term investments, net |
| 6,090,422 | ||||||||||
Increase (decrease) in other assets |
3,162 | (3,001 | ) | |||||||||
Proceeds from sale of equipment |
29,040 | | ||||||||||
Net cash provided by investing activities |
32,202 | 6,041,581 | ||||||||||
Cash Flows From Financing Activities: |
||||||||||||
Proceeds from issuance of common stock and warrants, net of
related offering costs and expenses |
466,992 | 5,826,537 | ||||||||||
Payments made on capital lease obligations |
(87,058 | ) | (407,290 | ) | ||||||||
Repurchase of common stock of a subsidiary |
(1,000 | ) | | |||||||||
Net cash provided by financing activities |
378,934 | 5,419,247 | ||||||||||
Net increase in cash and cash equivalents |
(935,433 | ) | 4,882,983 | |||||||||
Cash and cash equivalents, beginning of period |
1,511,942 | 749,213 | ||||||||||
Cash and cash equivalents, end of period |
$ | 576,509 | $ | 5,632,196 | ||||||||
Supplemental Cash Flow Information: |
||||||||||||
Interest paid |
$ | 377 | $ | 18,430 | ||||||||
Income taxes paid |
$ | 300 | $ | | ||||||||
Schedule of Non-Cash Investing and Financing Activities: |
||||||||||||
Unrealized (gain) loss on marketable securities |
$ | 390 | $ | 137,429 | ||||||||
Expiration of stock options |
$ | 1,394 | $ | | ||||||||
The accompanying notes are an integral part of these
condensed consolidated statements.
6
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
March 31,2003
(Unaudited)
1. | Organization and Business and Basis of Presentation, Liquidity and Going Concern |
Organization and Business
Organization
We incorporated Spectrum Pharmaceuticals, Inc. (Spectrum) in Colorado as Americus Funding Corporation (AFC) in December 1987. In August 1996, we changed AFCs name to NeoTherapeutics, Inc. and in June 1997, we reincorporated NeoTherapeutics, Inc. in the state of Delaware. In December 2002, NeoTherapeutics, Inc. changed its name to Spectrum Pharmaceuticals, Inc. We had three subsidiaries as of March 31, 2003: NeoTherapeutics GmbH, wholly owned, incorporated in Switzerland in April 1997 (or NeoGmbH); NeoGene Technologies, Inc., 88.4% owned, incorporated in California in October 1999 (or NeoGene); and NeoJB LLC, 80% owned by Spectrum and organized in California in April 2002. We dissolved two subsidiaries, NeoTravel, Inc., in December 2002 and NeoOncoRx, Inc. in February 2003. We merged a previously wholly owned subsidiary, Advanced ImmunoTherapeutics, Inc., into Spectrum Pharmaceuticals, Inc. in 2001. The accompanying consolidated financial statements include the operating results of Spectrum Pharmaceuticals, Inc. and its subsidiaries. Unless the context otherwise requires, all references to the Company, we, our, us and Spectrum refer to all of the companies above as a consolidated entity.
Business
We are a pharmaceutical company engaged in (1) the in-licensing of oncology drug candidates and the further development of and strategic alliances for these drug candidates, (2) the development and marketing of generic drugs in the United States and (3) the out-licensing of our neurology drug candidates to strategic partners.
Basis of Presentation, Liquidity and Going Concern
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-months ended March 31, 2003 are not necessarily indicative of the results that may be expected for the year ended December 31, 2003. The balance sheet at December 31, 2002 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, 2002.
Certain quarterly amounts have been reclassified to conform to the current period presentation. All share and per share information has been restated to affect for the 25-for-1 reverse split of our outstanding common stock approved on September 5, 2002 and executed on September 6, 2002.
7
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
(continued)
March 31,2003
(Unaudited)
Liquidity
On August 20, 2002, we announced a shift in our strategic focus from discovery and development of neurology drugs to the in-licensing of oncology drug candidates and the further development of and strategic alliances for these drug candidates and the out-licensing of our neurology drug candidates to strategic partners. As a result of these changes and the completion of a large Alzheimers disease clinical trial, our expense burn rate fell from approximately $7 million per quarter to approximately $1.7 million during the three-month period ended March 31, 2003, and we expect it to continue to fall to approximately $1.5 million, or lower, per quarter beginning in the second quarter of 2003. The recent and the prospective reduction in the burn rate is principally due to reductions in clinical, research and administrative personnel, the termination of a facility lease for office space used to administer the Alzheimers disease clinical trial, the reduction of expenses for the manufacturing of Neotrofin supplies (one of our neurology drug candidates), a reduction in our research and fellowship grant commitments, and the elimination of the research operations of our functional genomics business.
During the three-month period ended March 31, 2003, we sold 222,223 shares of our common stock for net cash proceeds of approximately $467,000 and issued warrants to purchase 55,555 shares of our common stock at an exercise price of $3.25 per share. Subsequent to March 31, 2003, we received gross cash proceeds from the issuance of shares of our convertible preferred stock of $4.4 million (for further information see Note 10 Subsequent Events).
On September 30, 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. Under the co-development and licensing agreement, Spectrum could receive up to $22 million in license fees and milestone payments. The license fee consists of a total of $4 million; $2 million received upon signing and $1 million in cash and a $1 million equity investment within 30 days after the first dosing of a patient in a registrational study. GPC Biotech has agreed to make additional payments totaling up to $18 million upon achieving agreed upon milestones. However, there can be no assurance that any milestone will be achieved. Furthermore, GPC Biotech has agreed to fully fund development and commercialization expenses for satraplatin. Upon commercial sale of satraplatin, if any, Spectrum will be entitled to receive royalty payments based upon net sales.
Our common stock was transferred from the Nasdaq National Market to the Nasdaq SmallCap Market where it began trading on October 16, 2002. To remain listed on this market, we must meet Nasdaqs continued listing requirements. Among other requirements, Nasdaq rules require that a SmallCap Market company maintain a minimum stockholders equity of $2.5 million or a minimum market value of listed securities of $35 million or a net income from continuing operations (in latest fiscal year or 2 of the last 3 fiscal years) of at least $500,000. As of March 31, 2003, we were not in compliance with this standard and have received a notice indicating that our securities are subject to delisting. The Company has requested and been granted a hearing before a Nasdaq Listing Qualifications Panel to review the delisting notice. As a result of the issuance of the convertible preferred stock, we believe we have regained compliance with this standard. There is no assurance that the Panel will grant the Companys request for continued listing and that we will be able to maintain compliance with any of the continued listing requirements. If we fail to do so, our common stock could be delisted from the Nasdaq SmallCap Market. Please see Risk Factors under Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations for alternatives should our common stock be delisted.
As shown in the accompanying condensed consolidated financial statements, we continue to incur significant losses and negative cash flow from operations. During the three-month period ended March 31, 2003, we incurred a loss of approximately $1.7 million.
2. | Joint Venture |
On April 17, 2002, we formed a joint venture with J.B. Chemicals & Pharmaceuticals Ltd. of Mumbai, India (JBCPL) and created a new entity, NeoJB LLC, a Delaware limited liability company (NeoJB). Spectrum owns 80% of NeoJB and a JBCPL subsidiary owns 20% of NeoJB. NeoJBs business operations include seeking U.S. regulatory approval of JBCPL pharmaceutical products and to subsequently market these products in the U.S. and possibly other countries. We will initially fund 100% of NeoJBs operating expenses. In conjunction with the formation of NeoJB, we granted a five-year warrant to JBCPL to purchase up to 4,000 shares of our common stock at an exercise price of $11.25 per share, equal to the market price of our common stock on the date of grant. The fair value of the warrant was estimated to be $38,000 using the Black-Scholes option pricing model with the following assumptions: dividend yield of 0%; expected volatility of 119.8%; risk free interest rate of 5.0%; and an expected life of five years.
8
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
(continued)
March 31, 2003
(Unaudited)
3. | Co-Development and License Agreement with GPC Biotech AG |
On September 30, 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. Under the co-development and licensing agreement, Spectrum could receive up to $22 million in license fees and milestone payments. The license fee consists of a total of $4 million; $2 million received upon signing and $1 million in cash and a $1 million equity investment within 30 days after the first dosing of a patient in a registrational study. GPC Biotech has agreed to make additional payments totaling up to $18 million upon achieving agreed upon milestones. However, there can be no assurance that any milestone will be achieved. Furthermore, GPC Biotech has agreed to fully fund development and commercialization expenses for satraplatin. Upon commercial sale of satraplatin, if any, Spectrum will be entitled to receive royalty payments based upon net sales. In accordance with our revenue recognition policy the initial payment of $2 million was recognized as revenue as the Company has satisfied its commitments under the license agreement.
4. | Commitments and Contingencies |
Research and Fellowship Grants
We periodically make non-binding commitments to various universities and not-for-profit research organizations to fund scientific research and fellowship grants that may further our research programs. During 2002, we terminated all research and fellowship grants and at December 31, 2002 and March 31, 2003, we had no commitments to pay any research or fellowship grants. Grant expense for the three-month periods ended March 31, 2003 and 2002, were approximately zero and $139,000, respectively, and is included in research and development on the consolidated statement of operations.
Debt and Capital Leases
Beginning in the second quarter of 2002, we were not in compliance with one of our debt covenants under our Master Note and Security Agreement secured by certain items of our lab equipment and computer software. An event of default had occurred because we had not maintained the required minimum balance of cash or equivalents. During the three-months ended September 30, 2002, we executed a modification of the lease providing the leaseholder a security interest in the property and equipment and accounts of the Company and in return, the leaseholder waived its rights to any remedies or actions due to the default.
Other
On September 30, 2002, the Company entered into a co-development and license agreement with GPC Biotech AG for the development and commercialization of our lead drug candidate, satraplatin. Under the agreement, we became obligated to maintain certain contractual obligations related to an underlying license agreement for satraplatin.
5. | Stockholders Equity |
Common Stock and Warrant transactions
On January 16, 2003, we sold 222,223 shares of our common stock at $2.25 per share for gross cash proceeds of $500,000 under our shelf registration statement. Included in this transaction was the issuance of warrants to purchase up to 55,555 shares of our common stock at an exercise price of $3.25 per share. The fair value of the warrants were estimated to be $83,000 using the Black-Scholes option pricing model with the following assumptions: dividend yield of 0%; expected volatility of 89.9% risk free interest rate of 2.8%; and an expected life of five years. Offering costs of this transaction were approximately $35,000.
On February 3, 2003, we entered into an agreement with a strategic investor who has agreed to invest $1 million in Spectrum to support the Companys emerging generic drug business. The investment will be subject to the achievement of two milestones, both of which relate to the first Abbreviated New Drug Application (ANDA) filed by Spectrum with the U.S. Food and Drug Administration
9
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
(continued)
March 31,2003
(Unaudited)
(FDA) in January 2003. The investor will purchase $250,000 of unregistered shares of our common stock upon acceptance by the FDA of the ANDA. The investor will purchase an additional $750,000 of unregistered shares of our common stock upon approval of this ANDA by the FDA. The purchase prices in the transactions will be at the closing price of our common stock on the day prior to acceptance and approval, respectively.
Comprehensive Loss
During the three-month periods ended March 31, 2003 and 2002, comprehensive loss was $1,696,942 and $6,442,893, respectively. For the three-month periods ended March 31, 2003 and 2002, other comprehensive loss of $390 and $137,429 consisted of unrealized gains and losses on our marketable securities and short-term investments that are held as available-for-sale.
6. | Equity Compensation |
Below is a summary of Spectrum stock option activity during the three-month period ended March 31, 2003:
Weighted Average | |||||||||
Shares | Exercise Price | ||||||||
Outstanding at December 31, 2002 |
601,799 | $ | 37.27 | ||||||
Granted |
135,000 | $ | 1.99 | ||||||
Forfeited |
(18,872 | ) | $ | 9.93 | |||||
Outstanding at March 31, 2003 |
717,927 | $ | 31.35 | ||||||
Exercisable at March 31, 2003 |
202,721 | $ | 96.94 | ||||||
Included in the granted options are options to purchase an aggregate of 135,000 shares at an exercise price of $1.99 per share granted to employees on March 28, 2003. These grants were made subject to stockholder approval of an increase in the number of shares subject to our 1997 Stock Incentive Plan. The Company also granted options to purchase an aggregate of 374,000 shares of our common stock during 2002, which were made subject to stockholder approval of an increase in the number of shares of our common stock subject to our 1997 Stock Incentive Plan. Upon stockholder approval, the options will be considered granted for accounting purposes and therefore may result in the recognition of deferred compensation, which would be amortized over the vesting period of the options. An increase in the number of shares of our common stock subject to our 1997 Stock Incentive Plan will be proposed at our next stockholder meeting.
We granted 54,080 stock options to employees in 2000 with exercise prices less than the fair market value of our common stock at the measurement date. The intrinsic value of the option grants amounting to $959,850 was recorded as deferred compensation and is being amortized to expense over the vesting period, in accordance with APB Opinion No. 25. During the three-month periods ended March 31, 2003 and 2002, we recorded compensation expense of $7,000 and $42,311, respectively, as a result of such amortization.
We account for stock options under the recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations. No stock-based employee compensation cost is reflected in net loss for options granted under those plans that have an exercise price equal to the market value of the underlying common stock on the date of grant. We recognize expense related to options granted that have an exercise price that is below the market price of the underlying stock at the time of grant and for options issued to non-employees. 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, for the three-months ended March 31, 2003 and 2002.
10
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
(continued)
March 31,2003
(Unaudited)
Three-Months | Three-Months | |||||||
Ended | Ended | |||||||
March 31, 2003 | March 31, 2002 | |||||||
Net loss, as reported |
(1,696,552 | ) | (6,305,464 | ) | ||||
Deduct: Total stock-based employee compensation
expense determined under fair value based method
for all awards, net of related tax effects |
(615,212 | ) | (1,041,678 | ) | ||||
Pro forma net loss |
$ | (2,311,764 | ) | $ | (7,347,142 | ) | ||
Loss per share: |
||||||||
Basic and diluted as reported |
$ | (0.58 | ) | $ | (6.50 | ) | ||
Basic and diluted pro forma |
$ | (0.79 | ) | $ | (7.57 | ) |
7. | Loss Per Share |
Basic and diluted loss per share for the three-month period ended March 31, 2003 and 2002 are computed using the weighted average common shares outstanding during the period, respectively.
8. | Litigation |
We are not aware of any litigation matters pending or threatened as of March 31, 2003 that will materially affect our condensed consolidated financial statements. We are sometimes involved in matters of litigation that we consider ordinary routine litigation incidental to our business. Our policy is to accrue during a period, as a charge to operations, amounts related to legal matters if it is probable that a liability has been incurred and the amount of loss can be reasonably estimated, as required by SFAS No. 5, Accounting for Contingencies.
9. | Income Taxes |
We did not provide any current or deferred federal or state income tax provision or benefit for the period presented because we have experienced operating losses since our inception. A valuation allowance has been recognized to fully offset the net deferred tax assets as of March 31, 2003 and December 31, 2002 as realization of such assets is uncertain.
10. | Subsequent Events |
On April 8, 2003, Spectrum announced that Nasdaq has notified the Company that it is not in compliance with Nasdaqs minimum stockholders equity requirement set forth in Marketplace Rule 4310(c)(2)(B), and that its securities are, therefore, subject to delisting from the Nasdaq SmallCap Market. The Company has requested a hearing before a Nasdaq Listing Qualifications Panel to review the Staff Determination. There can be no assurance the Panel will grant the Companys request for continued listing. However, the hearing request will stay the delisting of the Companys securities pending the Panels decision.
On April 14, 2003, the Company received notification from the FDA that it had accepted the ANDA for Ciprofloxican. As a result of this notification and in accordance with the agreement entered into on February 3, 2003, a strategic investor has agreed to purchase 125,628 shares of unregistered Spectrum common stock at $1.99 per share for total proceeds of $250,000 upon approval of the currency transfer by the Reserve Bank of India.
11
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Notes to Condensed Consolidated Financial Statements
(continued)
March 31,2003
(Unaudited)
On May 7, 2003, we sold 444 shares of our Series D 8% Cumulative Convertible Voting Preferred Stock and Series D Warrants to purchase shares of our common stock for gross cash proceeds of $4,440,000. The preferred stock is convertible into 1,889,361 shares of Spectrum common stock at a price of $2.35 per share. Dividends on the preferred stock are payable quarterly at an annual rate of 8 percent either in cash or shares of our common stock at the discretion of the Company. In addition, purchasers of the preferred stock received five-year warrants to purchase up to a total of 944,681 shares of our common stock at an exercise price of $3.00 per share and five-year warrants to purchase up to a total of 944,681 shares of our common stock at an exercise price of $3.50 per share. Under a preexisting agreement with a placement agent, we issued to a placement agent, in addition to cash fees, a five-year warrant to purchase up to a total of 188,936 shares of our common stock at an exercise price of $3.00 per share. Offering costs, including cash commissions paid to placement agents of this transaction, are estimated to be $545,000. The accompanying balance sheet reflects a pro-forma adjustment to effect for the issuance of the Series D Preferred Stock and receipt of the net proceeds of the offering.
SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
(formerly NeoTherapeutics, Inc.)
Pro-forma Condensed Consolidated Balance Sheets
March 31, | Pro-Forma | ||||||||||||
2003 | Adjustment | Adjusted | |||||||||||
Cash and cash equivalents |
$ | 576,509 | $ | 3,895,000 | $ | 4,471,509 | |||||||
Other current assets |
866,560 | 866,560 | |||||||||||
Property and equipment, net |
718,087 | 718,087 | |||||||||||
Other assets |
79,944 | 79,944 | |||||||||||
Total assets |
$ | 2,241,100 | $ | 3,895,000 | $ | 6,136,100 | |||||||
Current liabilities |
$ | 2,566,104 | $ | 2,566,104 | |||||||||
Capital lease obligations, net of current portion |
104,667 | 104,667 | |||||||||||
Other non-current liabilities |
121,951 | 121,951 | |||||||||||
Stockholders equity |
(551,622 | ) | $ | 3,895,000 | 3,343,378 | ||||||||
Total liabilities and stockholders equity |
$ | 2,241,100 | $ | 3,895,000 | $ | 6,136,100 | |||||||
12
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations
Note Regarding Forward-Looking Statements
This Quarterly Report on Form 10-Q contains certain 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 and Section 21E of the Securities Exchange Act of 1934. 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. Our actual results may differ materially from the results projected in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed below under Subsequent Events Affecting Future Results, Financial Market Risks, and Risk Factors.
You should read the following discussion of the financial condition and results of our operations in conjunction with the financial statements and the notes to those statements included elsewhere in this report.
Critical Accounting Polices and Estimates
Our discussion and analysis of our financial condition and results of operations are based upon our condensed consolidated financial statements, which have been 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. The preparation of these condensed consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis, we evaluate our estimates, including cash requirements resulting from estimating: planned research and development activities and general and administrative requirements, the retention of key personnel, certain clinical trial results, maintained market need for our product candidates and other major business assumptions.
We believe that our most significant accounting policies that affect our more significant judgments and estimates used in the preparation of our condensed consolidated financial statements are as follows:
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-months ended March 31, 2003 are not necessarily indicative of the results that may be expected for the year ended December 31, 2003. The balance sheet at December 31, 2002 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, 2002.
Certain quarterly amounts have been reclassified to conform to the current period presentation. All share and per share information has been restated to affect for the 25-for-1 reverse split of our outstanding common stock that was approved on September 5, 2002 and was effective on September 6, 2002.
Liquidity
On August 20, 2002, we announced a shift in our strategic focus from discovery and development of neurology drugs to the in-licensing of oncology drug candidates and the further development of and strategic alliances for these drug candidates and the out-licensing of our neurology drug candidates to strategic partners. As a result of these changes and the completion of a large Alzheimers disease clinical trial, our expense burn rate fell from approximately $7 million per quarter to approximately $1.7 million during the three-month period ended March 31, 2003, and we expect it to continue to fall to approximately $1.5 million, or lower, per quarter beginning in the second quarter of 2003. The recent and the prospective reduction in the burn rate is principally due to
13
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
reductions in clinical, research and administrative personnel, the termination of a facility lease for office space used to administer the Alzheimers disease clinical trial, the reduction of expenses for the manufacturing of Neotrofin supplies, a reduction in our research and fellowship grant commitments, and the elimination of the research operations of our functional genomics business.
During the three-month period ended March 31, 2003, we sold 222,223 shares of our common stock for net cash proceeds of approximately $467,000 and issued warrants to purchase 55,555 shares of our common stock at an exercise price of $3.25 per share. Subsequent to March 31, 2003, we received gross cash proceeds from the issuance of shares of our convertible preferred stock of $4.4 million (for further information see Note 10 Subsequent Events).
On September 30, 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. Under the co-development and licensing agreement, Spectrum could receive up to $22 million in license fees and milestone payments. The license fee consists of a total of $4 million; $2 million received upon signing and $1 million in cash and a $1 million equity investment within 30 days after the first dosing of a patient in a registrational study. GPC Biotech has agreed to make additional payments totaling up to $18 million upon achieving agreed upon milestones. However, there can be no assurance that any milestone will be achieved. Furthermore, GPC Biotech has agreed to fully fund development and commercialization expenses for satraplatin. Upon commercial sale of satraplatin, if any, Spectrum will be entitled to receive royalty payments based upon net sales.
Our common stock was transferred from the Nasdaq National Market to the Nasdaq SmallCap Market where it began trading on October 16, 2002. To remain listed on this market, we must meet Nasdaqs continued listing requirements. Among other requirements, Nasdaq rules require that a SmallCap Market company maintain a minimum stockholders equity of $2.5 million or a minimum market value of listed securities of $35 million or a net income from continuing operations (in latest fiscal year or 2 of the last 3 fiscal years) of at least $500,000. As of March 31, 2003, we were not in compliance with this standard and as a result we received a notice indicating that our securities are subject to delisting. The Company has requested and been granted a hearing before a Nasdaq Listing Qualifications Panel to review the delisting notice. As a result of the issuance of the convertible preferred stock, we believe we have regained compliance with this standard. There is no assurance that the Panel will grant the Companys request for continued listing and that we will be able to maintain compliance with any of the continued listing requirements. If we fail to do so, our common stock could be delisted from the Nasdaq SmallCap Market. Please see Risk Factors below for alternatives should our common stock be delisted.
As shown in the accompanying condensed consolidated financial statements, we continue to incur significant losses and negative cash flow from operations. During the three-month period ended March 31, 2003, we incurred a loss of approximately $1.7 million.
Principles of Consolidation
Our consolidated financial statements include our accounts including those of our wholly owned and majority owned subsidiaries. We eliminated all significant intercompany accounts and transactions.
Cash and Cash Equivalents
Cash and cash equivalents consist of cash and highly liquid investments of commercial paper and demand notes with original maturities of 90 days or less.
Marketable Securities and Short-Term Investments
We classify investments in debt securities among three categories: held-to-maturity, trading, and available-for-sale. As of March 31, 2003, all of our debt securities holdings were categorized as available-for-sale. We carry available-for-sale securities at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) in stockholders equity. We use quoted market prices to determine the fair value of these investments. If we believe that it is probable that we will be unable to collect all amounts due to us according to the contractual terms of an investment, we consider the impairment as other than temporary and would record an impairment loss.
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SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Prepaid Expenses and Refundable Deposits
Prepaid expenses are deferred and later recorded as an expense during the period benefited. Deposits are expected to become refundable at a later date.
Property and Equipment Purchased or Leased
We carry property and equipment at historical cost, less accumulated depreciation and amortization. When property and equipment are disposed of, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is reflected in income. Depreciation and amortization are computed using the straight-line method over the following estimated useful lives:
Equipment | 5 to 7 years | |
Leasehold Improvements | The shorter of the estimated useful life or lease term |
We review long-lived assets, including property and equipment, for impairment whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. We assess the recoverability of the affected long-lived assets by determining whether the carrying value of such assets can be recovered through undiscounted future operating cash flows. If impairment is indicated, we reduce the carrying value of the asset to fair value.
Research and Development
We expense all research and development activity costs in the period incurred.
Stock-Based Compensation
We account for those plans under the recognition and measurement principles of APB Opinion No. 25, Accounting for Stock Issued to Employees, and related Interpretations. No stock-based employee compensation cost is reflected in net loss for options granted under those plans that have an exercise price equal to the market value of the underlying common stock on the date of grant. We recognize expense related to options granted that have an exercise price that is below the market price of the underlying stock at the time of grant and for options issued to non-employees.
Basic and Diluted Net Loss Per Share
We calculate basic and diluted net loss per share using: the weighted average number of common shares outstanding and the net loss, less preferred stock dividends, during each year, respectively. We exclude all antidilutive common stock equivalents from the basic and diluted net loss per share calculation.
All share and per share information has been restated to reflect for the 25-for-1 reverse split of our outstanding common stock that was approved by our stockholders on September 5, 2002 and was effective on September 6, 2002.
Use of Estimates
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 resulting from estimating: planned research & development activities and general and administrative requirements, the retention of key personnel, certain clinical trial results, maintained market need for our product candidates and other major business assumptions. Actual results could differ from our estimates.
We have estimated that our current working capital plus funds raised or funds we are seeking to raise subsequent to the three-month period ended March 31, 2003 will be sufficient for us to continue as a going concern and therefore have prepared the financial statements on that basis. That basis includes estimating future cash requirements of planned research and development activities and general and administrative requirements, the retention of key personnel, certain clinical trial results, maintained market need for our product candidates, and other major business assumptions. If these estimates prove to be wrong, we may not be able to continue as a going concern.
15
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Revenue Recognition
We have adopted a strategy of co-developing or licensing our drug candidates. Accordingly, we have entered into collaborative research and development agreements and have received funding for pre-clinical research and clinical trials. Payments under these agreements, which are non-refundable, are recorded as revenue as the related research expenditures are incurred pursuant to the terms of the agreement and provided collectibility is reasonably assured. If no further commitments are required of us, the revenue is recognized when the license fee is payable or when all future commitments are satisfied.
License fees comprise initial fees and milestone payments derived from collaborative licensing arrangements. Non-refundable milestone payments continue to be recognized upon the achievement of specified milestones when we have earned the milestone payment, the milestone payment is substantive in nature and the achievement of the milestone was not reasonably assured at the inception of the agreement. We defer payments for milestone events which are reasonably assured and recognize them ratably over the minimum remaining period of our performance obligations. Payments for milestones which are not reasonably assured are treated as the culmination of a separate earnings process and are recognized as revenue when the milestones are achieved.
Income Taxes
We recognize deferred tax assets and liabilities for the future tax consequences attributable to differences between the financial statement bases and tax bases of existing assets and liabilities. We recorded a valuation allowance equal to our net deferred tax asset.
Results of Operations
For the three-months ended March 31, 2003, we incurred a net loss of approximately $1.7 million. We expect that our operating expenses will decrease in the immediate future as compared to the same period last year due to the shift in our strategic focus and the reduction of the operations during 2002. However, we expect to incur significant additional operating losses for at least the next several years unless such operating losses are offset, if at all, by licensing revenues under our agreement with GPC Biotech AG, strategic alliances with larger pharmaceutical companies that we are currently seeking or revenues from generic drug sales. The following is unaudited financial information for the three-months ended March 31, 2003 and 2002:
Three-Months Ended March 31, | ||||||||
2003 | 2002 | |||||||
Licensing revenue |
| 20,001 | ||||||
Research and development expenses |
852,784 | 4,924,123 | ||||||
General and administrative expenses |
845,258 | 1,478,511 | ||||||
Other income (expense) |
1,490 | 77,169 |
We had no revenues during the three-months ended March 31, 2003. Revenue for the three-months ended March 31, 2002 resulted from amortization of the licensing fee from the technology out-licensing agreements with Pfizer Inc. entered into during the second and fourth quarter of 2001. During the fourth quarter of 2002, we terminated our relationship with UCI and in February 2003 we executed a settlement agreement with UCI transferring all future rights to any milestone payments under these agreements to UCI for the satisfaction of certain accounts payable due to the Regents of the University of California and certain future obligations. As a result of the satisfaction of all future obligations by the Company to Pfizer during 2002, we recognized the remaining deferred revenue balance during fiscal 2002.
Research and development expenses for the three-months ended March 31, 2003 compared to the same period in 2002 decreased due primarily to the termination of our development efforts for Neotrofin, the elimination of our functional genomics subsidiary and the termination of pre-clinical research activities. During the three-months ended March 31, 2002, clinical trails for Neotrofin in the treatment of patients with Alzheimers disease, Parkinsons disease, spinal cord injury and neuropathy were underway. All of these trials were completed during 2002. Our decision to terminate the development of Neotrofin during 2002 resulted in a decrease in outside clinical research site costs, product manufacturing costs and salary and related benefit costs due to a reduction in research and development personnel. In addition, as part of the restructuring in 2002, we eliminated all activities at our functional genomics activities and only incurred costs in the amount of $67,000 during the three-months ended March 31, 2003 related to two lease agreements entered into in 2001. During the three-months ended March 31, 2002, our functional genomics subsidiary incurred
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SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
$815,000 in expenses. We also terminated our pre-clinical research activities during the fourth quarter of 2002 resulting in a further decrease in salary and related benefit costs due to a decrease in research personnel and research supplies.
General and administrative expenses for the three-month period ended March 31, 2003 compared to the same period in 2002 decreased due primarily to a lower level of personnel in 2003 when compared to the same period in 2002, a decrease in business activities in our functional genomics business and a decrease in general business expenses as a result of the restructuring and cost-cutting activities undertaken in 2002.
Other income for the three-month period ended March 31, 2003 compared to the same period in 2002 decreased due primarily to a decrease in interest income resulting from lower average marketable securities balances and lower interest rates.
Subsequent Events Affecting Future Results
On April 8, 2003, Spectrum announced that Nasdaq has notified the Company that it is not in compliance with Nasdaqs minimum stockholders equity requirement set forth in Marketplace Rule 4310(c)(2)(B), and that its securities are, therefore, subject to delisting from the Nasdaq SmallCap Market. The Company has requested a hearing before a Nasdaq Listing Qualifications Panel to review the Staff Determination. There can be no assurance the Panel will grant the Companys request for continued listing. However, the hearing request will stay the delisting of the Companys securities pending the Panels decision.
On April 14, 2003, the Company received notification from the FDA that it had accepted the ANDA for Ciprofloxican. As a result of this notification and in accordance with the agreement entered into on February 3, 2003, a strategic investor has agreed to purchase 125,628 shares of unregistered Spectrum common stock at $1.99 per share for total proceeds of $250,000 upon approval of the currency transfer by the Reserve Bank of India.
On May 7, 2003, we sold 444 shares of our Series D 8% Cumulative Convertible Voting Preferred Stock and Series D Warrants to purchase shares of our common stock for gross cash proceeds of $4,440,000. The preferred stock is convertible into 1,889,361 shares of Spectrum common stock at a price of $2.35 per share. Dividends on the preferred stock are payable quarterly at an annual rate of 8 percent either in cash or shares of our common stock at the discretion of the Company. In addition, purchasers of the preferred stock received five-year warrants to purchase up to a total of 944,681 shares of our common stock at an exercise price of $3.00 per share and five-year warrants to purchase up to a total of 944,681 shares of our common stock at an exercise price of $3.50 per share. Under a preexisting agreement with a placement agent, we issued to a placement agent, in addition to cash fees, a five-year warrant to purchase up to a total of 188,936 shares of our common stock at an exercise price of $3.00 per share. Offering costs, including cash commissions paid to placement agents of this transaction, are estimated to be $545,000.
Financial Condition
From inception through March 31, 2003, we financed our operations primarily through sales of securities, borrowings, grants, deferred payment of salaries and other expenses from related parties and payments received from technology out-license agreements.
At March 31, 2003, we had a net working capital deficit of approximately $1.1 million. Our working capital included cash and cash equivalents of approximately $577,000 and marketable securities and short-term investments of approximately $66,000. In comparison, at December 31, 2002, we had positive net working capital of approximately $50,000, which included cash and cash equivalents of approximately $1.5 million and short-term investments of approximately $66,000. The $1.2 million decrease in net working capital during the three-month period ended March 31, 2003 is attributable primarily to the loss of approximately $1.7 million, less non-cash expenses. Additionally, we used $87,000 to pay capital lease obligations. These uses of working capital were offset by net cash proceeds of approximately $467,000 from the sale of shares of our common stock.
We devote substantially all of our efforts to research and development. We incurred net losses of approximately $1.7 million during the three month period ended March 31, 2003, and expect to incur substantial losses over the next several years. We have historically funded our operations with funds from public offerings and private placement equity offerings. We will require substantial funds by June 2004, or sooner, in order to continue and complete the research and development activities currently contemplated and to commercialize our proposed products. Our future capital requirements and availability of capital will depend upon many factors, including continued scientific progress in research and development programs, the scope and results of pre-clinical studies and clinical trials, the time and costs involved in obtaining regulatory approvals, the cost involved in filing, prosecuting and enforcing patent
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SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
claims, the effect of competing technological developments, the cost of manufacturing scale-up, the cost of commercialization activities, and other factors which may not be within our control.
We believe over the long-term, profits from our generic business will help to reduce or possibly eliminate our reliance on the need to raise funds through the sale of our securities.
Contractual and Commercial Obligations
Debt and Capital Leases
Future installments of debt principal on capital lease obligations are as follows:
Year Ending | ||||
December 31: | Amount | |||
2003 |
$ | 272,000 | ||
2004 |
105,000 | |||
$ | 377,000 | |||
Facility, Property and Equipment Operating Leases
Minimum lease requirements for the remainder of the year ending December 31, 2003 and for the years ending December 31, 2004 through 2007 under the property and equipment leases are as follows:
Year Ending | ||||
December 31: | Amount | |||
2003 |
$ | 542,300 | ||
2004 |
424,700 | |||
2005 |
210,700 | |||
2006 |
84,900 | |||
2007 |
| |||
$ | 1,262,600 | |||
Research and Fellowship Grants
We periodically make non-binding commitments to various universities and not-for-profit research organizations to fund scientific research and fellowship grants that may further our research programs. During 2002, we terminated all research and fellowship grants and at December 31, 2002 and March 31, 2003, we had no commitments to pay any research or fellowship grants. Grant expense for the three-month periods ended March 31, 2003 and 2002, were approximately zero and $139,000, respectively, and is included in Research and Development on the Consolidated Statement of Operations.
Joint Ventures
On April 17, 2002, we formed a joint venture with J.B. Chemicals & Pharmaceuticals Ltd. of Mumbai, India (JBCPL) and created a new entity, NeoJB LLC, a Delaware limited liability company (NeoJB). Spectrum owns 80% of NeoJB and a JBCPL subsidiary owns 20% of NeoJB. NeoJBs business operations include seeking U.S. regulatory approval of JBCPL pharmaceutical products and to subsequently market these products in the U.S. and possibly other countries. We will initially fund 100% of NeoJBs operating expenses.
We are also reviewing other possible joint ventures to promote our strategic focus.
Financial Market Risks
We are exposed to certain market risks associated with interest rate fluctuations and credit risk on our marketable securities and borrowing arrangements. All investments in marketable securities and borrowing arrangements are entered into for purposes other
18
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
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 investments during the three-month period ended March 31, 2003 and as of March 31, 2003 are fixed rate, short-term corporate and government notes and bonds, which are available for sale. Because the interest rates are fixed, changes in interest rates affect the fair market value of these investments but do not affect the interest earnings. Because these financial instruments are considered available for sale, we record all changes in fair market value in stockholders equity as Accumulated other comprehensive income until the investment is either sold or matures, at which time the gain or loss, if any, is recognized as a realized gain or loss in the statement of operations. If a 10% change in interest rates were to have occurred on March 31, 2003, any decline in the fair value of our investments would not be material. In addition, we are exposed to certain market risks associated with the credit ratings of corporations whose bonds we have purchased. If these companies were to experience a significant detrimental change in their credit ratings, the fair market value of these corporate bonds may significantly decrease. If these companies were to default on their corporate bonds, we may lose part or all of the principal amount of our investment. We believe that we effectively manage this market risk by diversifying our corporate bond investments by purchasing a few bonds of many large, well-known, companies in a variety of industries.
As of March 31, 2003, we had one investment of approximately $61,000 in WorldCom, Inc. corporate bonds that matures on May 15, 2003. The fair market value of these corporate bonds at March 31, 2003 was approximately $16,000, based on a market quotation. In July 2002, WorldCom, Inc. and its subsidiaries filed a voluntary jointly administered petition under the U.S. Bankruptcy Code in the United States Bankruptcy Court for the Southern District of New York. We believe that it is probable that we will be unable to collect all amounts due to us according to the contractual terms of the corporate bonds, therefore, we consider the impairment as other than temporary and have recorded a loss for approximately $51,000 in other expense during the three-month period ended June 30, 2002.
Our primary market risk exposures relate to (1) interest rate risk on borrowings, (2) our ability to pay or refinance our borrowings at maturity at market rates, (3) interest rate risk on our investment portfolio, and (4) 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. We manage interest rate risk on our outstanding borrowings by using fixed rate debt. While we cannot predict or manage our ability to refinance existing borrowings and our interest rate risk on our investment portfolio, we evaluate our financial position on an ongoing basis.
Our borrowings bear interest at fixed rates. Changes in interest rates affect the fair value of our borrowings, but do not have an impact on interest expense. Because of the relatively short-term nature of our borrowings, fluctuations in fair value are not deemed to be material.
Risk Factors
The risk factors described below are not intended to be complete. A more comprehensive list of factors that could affect our future operating results can be found in our Annual Report on Form 10-K for the fiscal year ended December 31, 2002, in Item 1. Description of Business under the subheading Risk Factors. Failure to satisfactorily achieve any of our objectives or avoid any of the 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.
As shown in the accompanying condensed consolidated financial statements, we continue to incur significant losses and negative cash flow from operations. During the three-month period ended March 31, 2003, we incurred a loss of approximately $1.7 million. We anticipate that our expense rate will be reduced to approximately $1.5 million, or lower, per quarter starting with the second quarter. At March 31, 2003, we had cash, cash equivalents, marketable securities and short-term investments of approximately $643,000. Subsequent to March 31, 2003, we received gross cash proceeds from the issuance of shares of our convertible preferred stock of $4.4 million. Therefore, we will need to raise additional funds by June 2004, or sooner, through public or private financings, including equity financings or through other arrangements, to continue operating our businesses, including out-licensing our technology, to meet our short-term and long-term cash needs. We continue to seek additional sources of financing at the most favorable terms available to us, however, we do not know whether we will be able to secure sufficient new funds to continue our businesses. If we are not able to obtain sufficient funding within the time frame estimated by us, we will have to take other actions that we otherwise would not take, such as selling some or all of our intellectual property rights or further restructuring our operations, or a
19
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
combination of these activities, including the possibility of a restructuring or liquidation provided for by one of the sections of the United States Bankruptcy Code.
Our need for additional funding is substantial and will be determined by the progress and cost of the development and commercialization of our products and other activities. We will require substantial additional funds in order to continue the research and development activities currently contemplated and to commercialize our proposed products. The source, availability, and terms of such funds have not been determined and there is no assurance that we will be able to obtain any funding on acceptable terms or at all.
We have incurred losses in every year of our existence and expect to continue to incur significant operating losses for the next several years. We have never generated revenues from product sales and there is no assurance that revenue from product sales will ever be achieved. There is no assurance that any of our proposed products will ever be successfully developed, receive and maintain required governmental regulatory approvals, become commercially viable or achieve market acceptance.
Our business strategy requires that we establish and maintain good strategic alliances. Currently we are seeking strategic alliances but have limited experience in obtaining such alliances. We cannot give any assurance that we will be successful in establishing additional alliances or that we will be able to maintain existing and new alliances in a manner that is beneficial to us.
We have no experience in manufacturing, procuring products in commercial quantities or marketing, and only limited experience in negotiating, setting up or maintaining strategic relationships and conducting clinical trials or other late stage phases of the regulatory approval process, and there is no assurance that we will successfully engage in any of these activities.
We shifted our strategic focus from discovery and development of neurology drugs to the in-licensing of oncology drug candidates and the further development of and strategic alliances for these drug candidates and the out-licensing of our neurology drug candidates to strategic partners. As a result of these changes we made reductions in clinical, administrative and research personnel. We believe that we retained the correct, and a level of, personnel that are key to our success in executing our strategic focus. We may be wrong and later require additional personnel or personnel with skills different than those that we retained.
On September 30, 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 will not have complete control over the drug development process and therefore, the success of our lead drug candidate will depend upon the efforts of a third party. There is no assurance that GPC Biotech will be successful in the clinical development of the drug, the achievement of any milestones such as the acceptance of the NDA (New Drug Application) filing by the U.S. Food and Drug Administration or the eventual commercialization of satraplatin.
There were 2,948,241 shares of our common stock outstanding as of March 31, 2003. In addition, security holders held options, warrants and other rights as of March 31, 2003 which, if exercised, would obligate us to issue up to an additional 1,263,542 shares of common stock at a weighted average exercise price of $43.51 per share, of which 736,776 shares are subject to options or warrants which are currently exercisable at a weighted average exercise price of $63.50 per share. In addition, on May 7, 2003, we completed a financing resulting in the issuance of 444 shares of our Series D 8% Cumulative Convertible Voting Preferred Stock, which are convertible into a total of 1,889,361 shares of our common stock at a conversion price of $2.35 per share. In addition, the investors received 944,681 warrants to purchase our common stock at an exercise price of $3.00 per share and 944,681 warrants to purchase our common stock at an exercise price of $3.50 per share. A substantial number of those shares, when we issue them upon exercise, will be available for immediate resale in the public market. The market price of our common stock could fall as a result of such resales due to the increased number of shares available for sale in the market.
We have financed our operations, and we expect to continue to finance our operations, 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 earnings (loss) per share to decrease in future periods. As a result, the market price of our common stock could drop.
Certain provisions of the Preferred Stock and Warrant Purchase Agreement and Certificate of Designation, Rights and Preferences of the Series D 8% Cumulative Convertible Voting Preferred Stock (Preferred Stock) may require us to obtain the approval of the preferred stockholders to (i) amend, alter or repeal any provision of the Charter or Bylaws which may be deemed to adversely affect the terms of the Preferred Stock (ii) offer, sell or designate a security senior to or equal with the Preferred Stock, (iii) sell or issue common stock or securities convertible into or excersiable for shares of our common stock below $2.35 per share, (iv) incur any bank or non-
20
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
trade indebtedness, (v) grant or make any mortgage or pledge of our property, (vi) merge or consolidate with another entity or sell or dispose of substantially of all our assets or businesses or (vii) take certain other actions which may be deemed to adversely affect the terms of the Preferred Stock. These provisions may make it more difficult for management, the board of directors or stockholders of the Company to take certain corporate actions and could delay, discourage or prevent future financings. These provisions could also limit the price that certain investors might be willing to pay for shares of our common stock.
Our common stock was transferred from the Nasdaq National Market to the Nasdaq SmallCap Market where it began trading on October 16, 2002. To remain listed on this market, we must meet Nasdaqs continued listing requirements. Among other requirements, Nasdaq rules require that a SmallCap Market company maintain a minimum stockholders equity of $2.5 million or a minimum market value of listed securities of $35 million or a net income from continuing operations (in latest fiscal year or 2 of the last 3 fiscal years) of at least $500,000. As of March 31, 2003, we were not in compliance with this standard and have received a notice indicating that our securities are subject to delisting. The Company has requested and been granted a hearing before a Nasdaq Listing Qualifications Panel to review the delisting notice. As a result of the issuance of the shares of our convertible preferred stock, we believe we have regained compliance with this standard. However, there is no assurance that the Panel will grant the Companys request for continued listing or that we will be able to maintain compliance with any of the continued listing requirements. If we fail to do so, our common stock could be delisted from the Nasdaq SmallCap Market.
If our stock is delisted from the Nasdaq SmallCap Market, we would likely seek quotation on the American Stock Exchange or a regional stock exchange, if available. However, quotation on such a market or exchange could reduce the market liquidity for our common stock. If our common stock is not quoted on another market or exchange, trading of our common stock could be conducted in the over-the-counter market on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. As a result, an investor would find it more difficult to dispose of, or obtain accurate quotations for the price of, our common stock.
If our common stock is delisted from the Nasdaq SmallCap Market, we fail to obtain quotation on another market or exchange, and the trading price remains below $5.00 per share, trading in our common stock might also become subject to the requirements of certain rules promulgated under the Securities Exchange Act of 1934, which require additional disclosure by broker-dealers in connection with any trades involving a stock defined as a penny stock (generally, any equity security not listed on a national securities exchange or quoted on Nasdaq that has a market price of less than $5.00 per share, subject to certain exceptions). Many brokerage firms are reluctant to recommend low-priced stocks to their clients. Moreover, various regulations and policies restrict the ability of stockholders to borrow against or margin low-priced stocks and declines in the stock price below certain levels may trigger unexpected margin calls. Additionally, because brokers commissions on low-priced stocks generally represent a higher percentage of the stock price than commissions on higher priced stocks, the current share price of the common stock can result in an individual stockholder paying transaction costs that represent a higher percentage of total share value than would be the case if our share price were higher. This factor may also limit the willingness of institutions to purchase our common stock. Finally, the additional burdens imposed upon broker-dealers by these requirements could discourage broker-dealers from facilitating trades in our common stock, which could severely limit the market liquidity of the stock and the ability of investors to trade our common stock.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
See ITEM 2. Managements Discussion and Analysis of Financial Condition and Results of Operations, subheading Financial Market Risks, above.
ITEM 4. Controls and Procedures
(a) We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports under the Securities Exchange Act of 1934, as amended, 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 and our Vice President Finance and Strategic Planning (our senior financial officer), as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating the disclosure controls and procedures, management recognized that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives, and management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible controls and procedures.
Within 90 days prior to the date of this report, 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 and Strategic Planning, of the effectiveness
21
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
of the design and operation of our disclosure controls and procedures. Based on the foregoing, our Chief Executive Officer and our Vice President Finance and Strategic Planning concluded that our disclosure controls and procedures were effective.
(b) There have been no significant changes in the Companys internal controls or in other factors that could significantly affect the internal controls subsequent to the date the Company completed its evaluation.
PART II OTHER INFORMATION
ITEM 1. Legal Proceedings
None
ITEM 2. Changes in Securities and Use of Proceeds
On May 7, 2003, we issued 444 shares of Series D 8% Cumulative Convertible Voting Preferred Stock that have certain liquidation and dividend preferences over our common stock and Series B Junior Participating Preferred Stock holders. For more information, please see the Form 8-K filed with the Securities and Exchange Commission on May 14, 2003.
ITEM 3. Defaults Upon Senior Securities
None
ITEM 4. Submission of Matters to a Vote of Security Holders
None
ITEM 5. Other Information (not previously reported in a Form 8-K)
None
22
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
ITEM 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit No. | Description | ||
4.1 | Form of Warrant issued by the Registrant to three purchasers, dated as of January 16, 2003, to purchase up to an aggregate of 55,555 shares of our common stock. (Filed as Exhibit 4.1 to Form 8-K, as filed with the Securities and Exchange Commission on January 17, 2003 and incorporated herein by reference.) | ||
10.1 + | Limited Liability Agreement of NeoJB LLC, a Delaware limited liability company effective as of April 17, 2002 | ||
10.2 + | Supply Agreement dated April 16, 2002 by and between J.B. Chemicals & Pharmaceuticals Ltd. and NeoJB LLC | ||
10.3 + | Management Agreement dated April 16, 2002 by and between NeoTherapeutics, Inc., NeoJB LLC | ||
10.4 | Form of Securities Purchase Agreement by and between the Registrant and three investors, dated as of January 16, 2003, for the purchase of an aggregate of 222,223 shares of our common stock. (Filed as Exhibit 10.1 to Form 8-K, as filed with the Securities and Exchange Commission on January 17, 2003 and incorporated herein by reference.) | ||
99.1 + | Section 906 Certification of Chief Executive Officer | ||
99.2 + | Section 906 Certification of Vice President Finance and Strategic Planning |
+ Filed herewith
(b) Reports on Form 8-K
1. | We filed a Report on Form 8-K on January 2, 2003 with financial statements and accompanying notes thereto for the two-month and eleven-month period ended November 30, 2002, in order to show compliance with The Nasdaq Stock Market, Inc. requirements that we maintain a minimum stockholders equity of $2.5 million for continued listing on the Nasdaq SmallCap Market. | ||
2. | We filed a Report on Form 8-K on January 17, 2003 to report the completion of our January 16, 2003 offering of 222,223 shares of our common stock at a negotiated purchase price per share of $2.25 and warrants to purchase up to 55,555 shares of our common stock at an exercise price per share of $3.25 to three institutional investors for aggregate consideration of $500,001.75. The shares and warrants were issued pursuant to an effective shelf registration statement on Form S-3, file number 333-53108. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
SPECTRUM PHARMACEUTICALS, INC. | ||||
Date: May 14, 2003 | By: | /s/ John L. McManus | ||
John L. McManus, Vice President Finance and | ||||
Strategic Planning | ||||
(Authorized Signatory and Principal Financial Officer) |
23
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
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 quarterly 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 quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures 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 quarterly report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: May 14, 2003
/s/ Rajesh C. Shrotriya Rajesh C. Shrotriya, M.D. Chairman, Chief Executive Officer and President |
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
CERTIFICATION OF VICE PRESIDENT FINANCE AND STRATEGIC PLANNING
I, John McManus, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Spectrum Pharmaceuticals, Inc.;
2. Based on my knowledge, this quarterly 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 quarterly report;
3. Based on my knowledge, the financial statements, and other financial information included in this quarterly 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 quarterly report;
4. The registrants other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures 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 quarterly report is being prepared;
b) evaluated the effectiveness of the registrants disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the Evaluation Date); and
c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date;
5. The registrants other certifying officers and I have disclosed, based on our most recent evaluation, to the registrants auditors and the audit committee of registrants board of directors (or persons performing the equivalent function):
a) all significant deficiencies in the design or operation of internal controls which could adversely affect the registrants ability to record, process, summarize and report financial data and have identified for the registrants auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other employees who have a significant role in the registrants internal controls; and
6. The registrants other certifying officers and I have indicated in this quarterly report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses.
Date: May 14, 2003
/s/ John L. McManus John L. McManus Vice President Finance and Strategic Planning |
SPECTRUM PHARMACEUTICALS, INC.
(formerly NeoTherapeutics, Inc.)
Exhibit Index:
Exhibit No. | Description | ||
4.1 | Form of Warrant issued by the Registrant to three purchasers, dated as of January 16, 2003, to purchase up to an aggregate of 55,555 shares of our common stock. (Filed as Exhibit 4.1 to Form 8-K, as filed with the Securities and Exchange Commission on January 17, 2003 and incorporated herein by reference.) | ||
10.1 + | Limited Liability Agreement of NeoJB LLC, a Delaware limited liability company effective as of April 17, 2002 | ||
10.2 + | Supply Agreement dated April 16, 2002 by and between J.B. Chemicals & Pharmaceuticals Ltd. and NeoJB LLC | ||
10.3 + | Management Agreement dated April 16, 2002 by and between NeoTherapeutics, Inc., NeoJB LLC | ||
10.4 | Form of Securities Purchase Agreement by and between the Registrant and three investors, dated as of January 16, 2003, for the purchase of an aggregate of 222,223 shares of our common stock. (Filed as Exhibit 10.1 to Form 8-K, as filed with the Securities and Exchange Commission on January 17, 2003 and incorporated herein by reference.) | ||
99.1 + | Section 906 Certification of Chief Executive Officer | ||
99.2 + | Section 906 Certification of Vice President Finance and Strategic Planning |
+ Filed herewith