-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, Kdvc+0BwiGw7hOFS7Tyy7qZR1ppn9Hhn1r1XtCZ78BRZaithh7SB6al7M9mfOywy i7akLoS/B3XfzTSNoH+CLg== 0000950134-05-020495.txt : 20051104 0000950134-05-020495.hdr.sgml : 20051104 20051104083036 ACCESSION NUMBER: 0000950134-05-020495 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051104 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051104 DATE AS OF CHANGE: 20051104 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRUM PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000831547 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 930979187 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28782 FILM NUMBER: 051178607 BUSINESS ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497886700 MAIL ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: NEOTHERAPEUTICS INC DATE OF NAME CHANGE: 19960819 FORMER COMPANY: FORMER CONFORMED NAME: AMERICUS FUNDING CORP DATE OF NAME CHANGE: 19920703 8-K 1 a13976e8vk.htm FORM 8-K Spectrum Pharmaceuticals, Inc.
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES AND EXCHANGE ACT OF 1934
November 4, 2005 (November 4, 2005)
Date of Report (Date of earliest event reported)
 
SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other Jurisdiction
of Incorporation)
  000-28782
(Commission File Number)
  93-0979187
(IRS Employer
Identification Number)
         
157 Technology Drive
Irvine, California

(Address of principal executive offices)
      92618
(Zip Code)
(949) 788-6700
(Registrant’s telephone number, including area code)
N/A
(Former Name or Former Address, if Changed Since Last Report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 2.02. Results of Operations and Financial Condition.
Item 9.01. Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 2.02. Results of Operations and Financial Condition.
     On November 4, 2005, we issued a press release, which sets forth our results of operations for the quarter ended September 30, 2005. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Item 9.01. Financial Statements and Exhibits.
     (c) Exhibits
     
Exhibit No.   Description
99.1
  Press Release dated November 4, 2005.

 


Table of Contents

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 hereunto duly authorized.
         
  SPECTRUM PHARMACEUTICALS, INC.
 
 
Date: November 4, 2005  By:   /s/ Rajesh C. Shrotriya    
    Name:   Rajesh C. Shrotriya, M.D.   
    Title:   Chairman, Chief Executive Officer and President   

 


Table of Contents

         
EXHIBIT INDEX
     
Exhibit No.   Description
99.1
  Press Release dated November 4, 2005.

 

EX-99.1 2 a13976exv99w1.htm EXHIBIT 99.1 Press Release
 

Exhibit 99.1
(SPECTRUM PHARMACEUTICALS, INC. LOGO)
Contact:
     Laurie Little
     Sr. Director, Investor Relations
     (949) 743-9216
Spectrum Pharmaceuticals Reports Third Quarter 2005
Financial and Operating Results
    $68.6 million in cash and marketable securities as of September 30, 2005
 
    $184,000 in revenues; $5.2 million net loss for the 3rd quarter
 
    Seven proprietary drug candidates under development, including one in Phase 3 and four in multiple Phase 2 clinical trials
 
    Nine generic drug ANDAs pending at the FDA, one with Paragraph IV certification
 
    Conference call webcast at www.spectrumpharm.com on Friday, November 4, 2005 at 10:00 a.m. ET (7:00 a.m. PT)
          IRVINE, Calif., November 4, 2005 — Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today reported a net loss for the three months ended September 30, 2005 of approximately $5.2 million, or $0.32 per share, compared to a net loss of approximately $4.1 million, or $0.29 per share for the same period in 2004. The approximately $1.2 million increase in net loss for the third quarter of 2005 reflects the continued advancement of the Company’s product portfolio, and was primarily due to increases in research and development expense and increased legal expense in connection with the lawsuit regarding our patent challenge of GlaxoSmithKline’s Imitrex® injection, offset by a decrease in stock-based charges.
          In September 2005, the Company raised $42 million at $5.25 per share from leading biotech investors. As a result, the Company had cash and marketable securities of approximately $68.6 million as of September 30, 2005, compared to approximately $33.0 million as of June 30, 2005.
          As of November 1, 2005, there were approximately 23.4 million shares of common stock outstanding.
          Revenues for the third quarter of 2005 were $184,000 from product sales and commissions under a licensing agreement. This compares to no revenues in the third quarter of 2004.
          Research and development expenses increased from approximately $2.4 million in the third quarter of 2004 to approximately $3.3 million in the third quarter of 2005,

 


 

primarily reflecting the expansion in the number and scope of our clinical trials and other development activity.
          General and administrative expenses increased by approximately $1.0 million from approximately $1.2 million in the third quarter of 2004 to approximately $2.2 million in the third quarter of 2005, primarily due to an increase in legal expense in connection with the lawsuit regarding our patent challenge of GlaxoSmithKline’s Imitrexâ Injection.
          “Spectrum has continued to make significant advancements in its corporate objectives” stated Rajesh C. Shrotriya, Chairman, Chief Executive Officer and President. “Our clinical programs advanced during the quarter in accordance with our plans. In addition, a European trial evaluating ozarelix in prostate cancer has completed patient enrollment four months ahead of schedule; the FDA approved our ANDA for fluconazole; and an important clinical study with EOquin was initiated in Europe. The recent financing enables the Company to continue executing its business plan for the benefit of shareholders. Further, as the Company gets closer to generating revenues the need for additional financings in the future is likely to be reduced.”
Development Highlights and Future Objectives
Satraplatin (Phase 3 pivotal SPARC trial being conducted by our partner GPC Biotech)
    Patient enrollment in the trial is proceeding as planned, 840 patients were enrolled as of October 26, 2005, with a goal of completing full enrollment of approximately 912 patients by December 2005.
 
    A Rolling NDA for accelerated approval is expected to commence by the end of this year.
 
    Completion of a full NDA filing is expected during the second half of next year.
 
    Interim analysis by the Independent Data Safety Monitoring Board is expected to be available at the end of the first quarter 2006.
 
    A Phase 2 trial evaluating satraplatin in breast cancer was recently opened for accrual.
EOquinä (EO-9)
    EOquin™ Phase 2 report is currently being finalized and plans to present that data at a scientific conference are proceeding.
 
    Plans are underway to schedule a meeting with the FDA by the end of the year to discuss our plans for initiating a Phase 3 trial in 2006, in the United States, to evaluate EOquin™ in superficial bladder cancer.
 
    Plans to initiate a Phase 3 study in Europe in 2006 are also in preparation.
 
    An Abstract on radiation sensitization by EO-9 will presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics to be held in November 2005.
Elsamitrucin
    A multicenter, Phase 2 clinical trial in refractory non-Hodgkin’s lymphoma, especially in Rituxanâ failures, is running at approximately 30 centers in the US.
 
    Completion of enrollment is expected by the end of 2005.
 
    Plans are underway to initiate a Phase 2 study in head and neck cancer and other pilot combination studies.

 


 

Ozarelix
    In April, we initiated two Phase 2 multicenter clinical trials in Europe for ozarelix, one in hormone-dependent prostate cancer (HDPC) and one for benign prostate hypertrophy. Enrollment is now completed in the HDPC trial, four months ahead of the planned completion date.
 
    An Investigational New Drug Application (IND) was submitted earlier this year and subsequently received concurrence from the U.S. Food and Drug Administration (FDA) to conduct a Phase 1/2 clinical trial in patients with HDPC in the United States, which has been initiated.
Lucanthone
    Plans are being developed to expand the Phase 2 clinical trial.
RenaZorb™
    RenaZorb™ is in pre-clinical development and we are planning to begin clinical trials in humans next year upon FDA approval.
SPI — 1620
    SPI-1620 is in pre-clinical development and we are planning to begin clinical trials in humans next year upon FDA approval.
 
    An abstract on SPI-1620 as a novel adjuvant to enhance the delivery and efficacy of paclitaxel will be presented at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics to be held in November 2005.
Generics
    On September 28, 2005, we received FDA approval of our fluconazole tablets Abbreviated New Drug Application (ANDA).
 
    We recently filed one ANDA with the FDA, bringing the total number of ANDAs filed in 2005 to five, exceeding our original goal.
 
    We currently have nine ANDAs under review at the FDA and we expect several approvals over the next 6-12 months.
          As previously announced, the Company will hold a conference call on Friday, November 4, 2005 at 10:00 a.m. (Eastern Time) to review the results of the third quarter of 2005 and discuss the outlook for the rest of the year and beyond. Investors, analysts and the public are invited to listen to the conference call over the internet by visiting our website at http://www.spectrumpharm.com. To listen to this call live on the Internet, visit the investor relation’s section of Spectrum’s Web site at least 20 minutes early (to download and install any necessary audio software).
About Spectrum Pharmaceuticals
          Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.

 


 

Forward-looking statements
          This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, the continued advancement of the Company’s product portfolio, making significant advancements in the Company’s corporate objectives, the recent financing’s ability to enable the Company to continue executing its business plan for the benefit of shareholders, generating revenues, the likelihood of the need for additional financings in the future, completing full enrollment of satraplatin of approximately 912 patients by December 2005, filing a Rolling NDA for accelerated approval for satraplatin by the end of this year, completion of a full NDA filing for satraplatin during the second half of next year, interim analysis of the satraplatin data by the Independent Data Safety Monitoring Board at the end of the first quarter 2006, finalization of the EOquin™ Phase 2 report, plans to present that data at a scientific conference, a meeting with the FDA about EOquin by the end of the year to discuss our plans for initiating a Phase 3 trial in 2006, in the United States, to evaluate EOquin™ in superficial bladder cancer, plans to initiate a Phase 3 study of EOquin in Europe in 2006, the presentation of an Abstract on radiation sensitization by EO-9 at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics to be held in November 2005, completion of enrollment of the elsamitrucin clinical trial by the end of 2005, plans to initiate a Phase 2 study of elsamitrucin in head and neck cancer and other pilot combination studies, plans to expand the lucanthone Phase 2 clinical trial, beginning clinical trials in humans with RenaZorb™ next year, beginning clinical trials in humans with SPI-1620 next year, the presentation of an abstract on SPI-1620 as a novel adjuvant to enhance the delivery and efficacy of paclitaxel at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics to be held in November 2005, several approvals of our ANDAs over the next 6-12 months , and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that past results may not be indicative of future results, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the possibility that our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of significant revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission.
###

 


 

SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
(In thousands, except Share and per share data)
Summary Condensed Consolidated Statement of Operations (Unaudited)
                                 
    Quarter Ended September 30,     Nine Months Ended September 30,  
    2005     2004     2005     2004  
 
                               
Revenues
  $ 184     $     $ 424     $ 73  
     
 
                               
Operating expenses:
                               
Cost of product sold
    103             324        
Research and development
    3,252       2,372       10,319       4,546  
General and administrative
    2,152       1,168       4,721       3,785  
Stock-based charges
    169       707       863       865  
     
Total operating expenses
    5,676       4,247       16,227       9,196  
     
Loss from operations
    (5,492 )     (4,247 )     (15,803 )     (9,123 )
Other income, net
    264       178       754       314  
     
Net loss before minority interest in consolidated subsidiary
    (5,228 )     (4,069 )     (15,049 )     (8,809 )
Minority interest in net loss of consolidated subsidiary
                  4          
     
Net loss
  $ (5,228 )   $ (4,069 )   $ (15,045 )   $ (8,809 )
     
Basic and diluted net loss per share
  $ (0.32 )   $ (0.29 )   $ (0.96 )   $ (0.74 )
     
 
                               
Basic and diluted weighted average common shares outstanding
    16,666,960       14,063,355       15,723,509       12,052,017  
     
 
                               
Supplemental Information
                               
Stock-based charges — Components:
                               
Research and development
  $ 147     $ 635     $ 801     $ 640  
General and administrative
  $ 22     $ 72     $ 62     $ 225  
     
Total stock based charges
  $ 169     $ 707     $ 863     $ 865  
     
Summary Condensed Consolidated Balance Sheets (Unaudited)
                 
    September 30,     December 31,  
    2005     2004  
 
               
Cash, cash equivalents and marketable securities
  $ 68,622     $ 39,206  
Accounts Receivable
    354       199  
Inventory
    143       224  
Other current assets
    138       372  
     
Total current assets
    69,257       40,001  
Property and equipment, net and other assets
    807       757  
     
Total assets
  $ 70,064     $ 40,758  
     
 
               
Total liabilities
  $ 5,582     $ 2,844  
Minority Interest
    20       24  
Stockholders’ equity
    64,462       37,890  
     
Total liabilities and stockholders’ equity
  $ 70,064     $ 40,758  
     

 

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