-----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, OumqU0G/AeFpB2HRr/Y/McrCAg1RDj+D6bhvSoEJnCd52s4gmZ2/TBjPzNZiW3hi ALukq6xUU5FGDrzknRr/cA== 0000950123-09-034374.txt : 20090813 0000950123-09-034374.hdr.sgml : 20090813 20090813073036 ACCESSION NUMBER: 0000950123-09-034374 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20090813 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090813 DATE AS OF CHANGE: 20090813 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: 091008455 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 c89114e8vk.htm FORM 8-K Form 8-K
 
 

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 Exchange Act of 1934

Date of Report (Date of earliest event reported): August 13, 2009

SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   000-28782   93-0979187
(State or other Jurisdiction of Incorporation)   (Commission File Number)   (IRS Employer Identification No.)
     
157 Technology Drive
Irvine, California
  92618
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (949) 788-6700
 
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))

 
 

 

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Item 2.02 Results of Operations and Financial Conditions.

On August 13, 2009, we issued a press release, which sets forth our results of operations for the quarter ended June 30, 2009. 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.

(d) Exhibits

     
 
   
Exhibits:
  Description of Document
 
   
 
   
99.1
  Press Release dated August 13, 2009.

 

 

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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.

Date: August 13, 2009

SPECTRUM PHARMACEUTICALS, INC.

By: /s/ Shyam Kumaria
Name: Shyam Kumaria
Title: V.P. Finance 

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EXHIBIT INDEX

     
 
   
Exhibits:
  Description of Document
 
   
 
   
99.1
  Press Release dated August 13, 2009.

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EX-99.1 2 c89114exv99w1.htm EXHIBIT 99.1 Exhibit 99.1
Exhibit 99.1
(LOGO)
     
COMPANY CONTACTS
   
Russell Skibsted
  Paul Arndt
Chief Business Officer
  Senior Manager, Investor Relations
949-788-6700x234
  949-788-6700x216
SPECTRUM PHARMACEUTICALS ANNOUNCES SECOND QUARTER 2009 CORPORATE UPDATE
 
Strong Cash Position to Continue to Execute on Business Plan With $106M in Cash, Equivalents, and Financing Receivable as of June 30, 2009
 
 
$8.1M in 2Q09 Revenue
 
 
2Q09 ZEVALIN® Net Sales vs. 1Q09 ZEVALIN Net Sales Up 25%
 
 
FDA Decision on sBLA for ZEVALIN in First Line non-Hodgkin’s Lymphoma Expected By September 7th
 
 
FDA Decision on sNDA for FUSILEV™ in Metastatic Colorectal Cancer Expected By October 8th
IRVINE, California — August 13, 2009 — Spectrum Pharmaceuticals, Inc. (NasdaqGM: SPPI), a commercial-stage biotechnology company with a primary focus in oncology, today reported financial results for the second quarter ended June 30, 2009.
“During the quarter, we made significant progress toward stabilizing, and ultimately growing, ZEVALIN® sales, even before its approval in the first line setting,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “We continue to expect favorable regulatory decisions on both ZEVALIN and FUSILEV’s PDUFAs in September and October, respectively.”
Second Quarter Results Ended June 30, 2009
Consolidated revenue of $8.1 million was comprised of product sales of $6.0 million — $3.3 million from ZEVALIN and $2.7 million from FUSILEV — and $2.1 million attributable to the amortization of the Allergan licensing fee. This compares to $20.7 million in one-time, non-recurring revenue in the same period of 2008. The Company recorded a net loss of $9.7 million, or ($0.28) per share, compared to net income of $10.7 million, or $0.34 per share, in the second quarter of 2008. Research and development expenses were $7.3 million, as compared to $6.7 million in the same period of 2008, a $0.6 million, or 9.0% increase, mainly due to the amortization of purchased intangibles of ZEVALIN. Selling, general and administrative expenses were $9.2 million, a $6.0 million increase, compared to the $3.2 million in the same period in 2008, attributable to the commercialization of ZEVALIN and FUSILEV.
Six-Month Results Ended June 30, 2009
Consolidated revenue of $22.3 million was comprised of product sales of $18.1 million — $5.9 million from ZEVALIN and $12.2 million from FUSILEV — and $4.2 million attributable to the amortization of the Allergan licensing fee. This compares to $20.7 million in one-time, non-recurring revenue in the same period of 2008. The Company recorded a net loss of $9.1 million, or ($0.27) per share, compared to net income of $2.0 million, or $0.06 per share, in the same period of 2008. Research and development expenses were $13.9 million, as compared to $13.1 million in the same period of 2008, a $0.8 million, or 6% increase, mainly due to the amortization of purchased intangibles of ZEVALIN. Selling, general and administrative expenses were $15.5 million, a $9.7 million increase, compared to the $5.8 million in the same period in 2008, attributable to the commercialization of ZEVALIN and FUSILEV.
Net cash provided by operations in the six month period ended June 30, 2009 was $4.3 million. The positive operating cash flows are primarily due to sales of FUSILEV, arbitration proceeds related to ZEVALIN, and the contribution to research and development expenses by Allergan, Inc.
 
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

During the second quarter ended June 30, 2009, the company sold 8.5 million shares of common stock for $51 million in gross proceeds. As of June 30, 2009, the Company had cash, cash equivalents, marketable securities, and financing proceeds receivable of $106 million, compared to $64 million as of March 31, 2009. As of August 7, 2009, there were 42 million shares issued and outstanding.
     
*  
All numbers above are approximates.
Value Drivers in the Next 12-18 Months:
ZEVALIN
   
September 7, 2009 PDUFA action date for 1st line NHL consolidation therapy; and,
 
   
Establish reimbursement standards in concert with Centers for Medicare and Medicaid Services (CMS) by early 2010.
FUSILEV
   
October 8, 2009 PDUFA action date for advanced metastatic colorectal cancer. Apaziquone (EOquin®)
 
   
Complete enrollment in ongoing phase 3 registrational trials by year end;
   
Enrolled more than 1,200 patients to date,
   
Initiate trials in BCG-Failure bladder cancer by year end; and,
 
   
Sign an Asian partnership by year end.
Conference Call
Thursday, August 13, 2009 @ 12:00p.m. Eastern/9:00 a.m. Pacific
             
    Domestic:   888-359-3613    
    International:   719-325-2392    
Webcast and replays: www.spectrumpharm.com.
Audio replays will be available through August 27, 2009.
             
    Domestic:   888-203-1112, passcode 1662447    
    International:   719-457-0820, passcode 1662447    
About ZEVALIN® (ibritumomab tiuxetan)
ZEVALIN® is a form of cancer therapy called radioimmunotherapy and is indicated as part of the ZEVALIN therapeutic regimen for treatment of relapsed or refractory, low-grade or follicular B-cell NHL, including patients with rituximab-refractory follicular NHL. ZEVALIN is also indicated, under accelerated approval, for the treatment of relapsed or refractory, rituximab-naïve, low-grade and follicular NHL. It was approved by the FDA in February of 2002 as the first radioimmunotherapeutic agent for the treatment of NHL.
For more information on ZEVALIN, patients and healthcare professionals can visit www.ZEVALIN.com.
About FUSILEV™ (levoleucovorin) for Injection
FUSILEV™, a novel folate analog, is available in 50-mg vials of freeze-dried powder. It is the pharmacologically active isomer of leucovorin. FUSILEV rescue is indicated after high-dose methotrexate therapy in osteosarcoma. FUSILEV is also indicated to diminish the toxicity and counteract the effects of impaired methotrexate elimination and of inadvertent overdosage of folic acid antagonists. FUSILEV (levoleucovorin or (6S)-leucovorin) is the only commercially available formulation comprised only of the pharmacologically active isomer of leucovorin.
Full prescribing information can be found at www.FUSILEV.com.
 
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

About Spectrum Pharmaceuticals
We are a commercial-stage biotechnology company with a focus in oncology. Our strategy is comprised of acquiring and developing a broad and diverse pipeline of late-stage clinical and commercial products; establishing a commercial organization for our approved drugs; continuing to build a team with people who have demonstrated skills, passion, commitment and have a track record of success in our areas of focus; and, leveraging the expertise of partners around the world to assist us in the execution of our strategy. For more information, please visit our website at www.spectrumpharm.com.
Forward-looking statement — 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, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, establishing a commercial organization for our approved drugs, continuing to build our team, leveraging the expertise of partners around the world to assist us in the execution of our strategy, the safety and efficacy of FUSILEV and ZEVALIN, that we continue to expect favorable regulatory decisions on both ZEVALIN and FUSILEV’s PDUFAs in September and October, respectively, establishing reimbursement standards in concert with Center for Medical Services (CMS) for ZEVALIN in early 2010, completing enrollment for apaziquone in the two ongoing registrational Phase 3 clinical trials for non-muscle-invasive bladder cancer by year end, initiating trials for apaziquone in BCG-Failure bladder cancer by year end, that we will sign an Asian partnership for apaziquone by year end 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 our efforts to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited marketing experience, 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. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law.
SPECTRUM PHARMACEUTICALS, INC. ™, TURNING INSIGHTS INTO HOPE™, FUSILEV™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc. ZEVALIN® is a registered trademark of RIT Oncology LLC, a subsidiary of Spectrum Pharmaceuticals, Inc. EOquin is a registered trademark of Allergan, Inc.
© 2009 Spectrum Pharmaceuticals, Inc. All Rights Reserved.
 
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 


 

SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES
(In thousands, except Share and per share data)
Summary Condensed Consolidated Statement of Operations (Unaudited)
                                 
    Quarter Ended June 30,     Six Months Ended June 30,  
    2009     2008     2009     2008  
 
                               
Revenues
  $ 8,141     $ 20,676     $ 22,305     $ 20,676  
 
                       
 
                               
Operating expenses:
                               
Cost of product sold
    1,439             3,273        
Research and development
    7,341       6,747       13,945       13,129  
Selling, general and administrative
    9,192       3,230       15,543       5,815  
 
                       
 
                               
Total operating expenses
    17,972       9,977       32,761       18,944  
 
                       
 
                               
Income / (Loss) from operations
    (9,831 )     10,699       (10,456 )     1,732  
 
                               
Other income, net
    125       (21 )     229       280  
 
                       
 
                               
Loss before minority interest in consolidated entities
    (9,706 )     10,678       (10,227 )     2,012  
Minority interest in net loss of consolidated subsidiary
                1,146        
 
                       
Net income (loss)
  $ (9,706 )   $ 10,678     $ (9,082 )   $ 2,012  
 
                       
 
                               
Basic and diluted net loss per share
  $ (0.28 )   $ 0.34     $ (0.27 )   $ 0.06  
 
                       
Diluted
  $ (0.28 )   $ 0.34     $ (0.27 )   $ 0.06  
 
                       
 
                               
Basic and diluted weighted average common shares outstanding
    34,582,640       31,462,522       33,517,002       31,366,902  
 
                       
Diluted
    34,582,640       31,869,079       33,517,002       31,822,132  
 
                       
Summary Condensed Consolidated Balance Sheets (Unaudited)
                 
    June 30,     December 31,  
    2009     2008  
Cash, cash equivalents, marketable securities and financing funds receivable
  $ 106,055     $ 78,086  
 
               
Accounts Receivable, net
    1,531       5,002  
Inventory
    2,355       1,841  
Other current assets
    661       693  
 
           
Total current assets
    110,602       85,622  
Intangible Assets, net
    35,143       37,042  
Property and equipment, net and other assets
    1,944       2,071  
 
           
Total assets
  $ 147,689     $ 124,735  
 
           
 
               
Total liabilities
  $ 65,171     $ 70,854  
Commitments & Contingencies
           
Minority Interest
          14,262  
Stockholders’ equity
    82,518       39,619  
 
           
Total liabilities and stockholders’ equity
  $ 147,689     $ 124,735  
 
           
 
157 Technology Dr Irvine, California 92618 Tel: 949-788-6700 Fax: 949-788-6706 www.spectrumpharm.com NASDAQ: SPPI

 

 

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