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8-K - FORM 8-K - SPECTRUM PHARMACEUTICALS INCd310429d8k.htm

Exhibit 99.1

 

LOGO

 

COMPANY CONTACTS

 

Shiv Kapoor

  Paul Arndt

Vice President, Strategic Planning & Investor Relations

  Senior Manager, Investor Relations

702-835-6300

  702-835-6300

SPECTRUM PHARMACEUTICALS REPORTS RECORD REVENUES, PROFITS, AND CASH GENERATED FROM OPERATIONS FOR THE TWELVE-MONTH PERIOD ENDED DECEMBER 31, 2011

 

   

Financial Highlights:

 

   

First Full Year of Profitability Since Inception in 2002

 

   

Total Revenues of $193 Million in 2011, Up 160% From Previous Record Revenues of $74 Million in 2010, Comprised of Product Sales of $181 Million:

 

   

$153 Million From FUSILEV

 

   

$28 Million From ZEVALIN

 

   

Non-GAAP EPS of $1.25 Per Diluted Share in 2011, Up From a Loss of $0.87 in 2010

 

   

$222 Million in Cash, Cash Equivalents, Investments and Receivables as of December 31, 2011, Compared to $125 Million as of December 31, 2010

 

   

Stock Repurchase Program Initiated in 2011 Remains in Place

 

   

Two New Drug Applications on Track for Filing in 2012

 

   

Apaziquone Pivotal, Registrational Data Expected Soon

 

   

Belinostat Pivotal, Registrational Data Expected Later in the Year

 

   

Stage Is Set For Long-Term ZEVALIN Growth

 

   

Worldwide Commercial Strategy Being Executed

 

   

Expanded Clinical Development Program Underway

 

   

Repositioning Campaign Capitalizes on the Bioscan Removal to Augment Market Penetration

HENDERSON, Nevada – March 1, 2012 – Spectrum Pharmaceuticals, Inc. (NasdaqGS: SPPI), a biotechnology company with fully integrated commercial and drug development operations with a primary focus in hematology and oncology, today reported financial results for the three- and twelve-month periods ended December 31, 2011.

“A 160% increase in annual total revenues and a healthy year-end balance sheet made 2011 a landmark year,” said Rajesh C. Shrotriya, MD, Chairman, Chief Executive Officer, and President of Spectrum Pharmaceuticals. “Today, Spectrum Pharmaceuticals is in a strong position for solid growth over the next 5 years. We have two approved drugs with significant growth potential and two novel drugs in late-stages of development with pivotal data expected this year. We look forward to the results of our pivotal registrational program for apaziquone soon, and for belinostat later in the year. Based on our growing pipeline and product portfolio, we expect 2012 to be another transformational year for Spectrum.”

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


Twelve-Month Period Ended December 31, 2011 (All #s are Approximate)

Consolidated revenue of $193 million was comprised of product sales of $181 million and $12 million from licensing fees. This represents a 160% increase from the $74 million in consolidated revenue recorded in the twelve-month period of 2010, which was comprised of product sales of $61 million and $13 million from licensing fees.

Non-GAAP Results

The Company recorded non-GAAP net income of $72 million, or $1.36 per basic share and $1.25 per diluted share in the twelve month period ended December 31, 2011, compared to a net loss of $43 million, or ($0.87) per basic and diluted share in 2010. Non-GAAP research and development expenses were $26 million, as compared to $55 million in the same period of 2010, which included the $30 million up-front licensing fee for belinostat. Non-GAAP selling, general and administrative expenses were $52 million, as compared to $43 million in the same period in 2010.

GAAP Results

The Company recorded net income of $49 million, or $0.91 per basic and $0.84 per diluted share in the twelve month period ended December 31, 2011, compared to a net loss of $49 million, or ($0.99) per basic and diluted share in 2010. Total research and development expenses were $28 million in 2011, as compared to $57 million in 2010, which included the $30 million up-front licensing fee for belinostat. Selling, general and administrative expenses were $73 million in 2011, which included non-cash charges of $21 million, compared to $49 million in 2010, which included non-cash charges of $6 million.

During the twelve-month period ended December 31, 2011, net cash provided by operations was approximately $43 million. Cash, equivalents, investments and receivables as of December 31, 2011 aggregated $222 million, as compared to $125 million as of December 31, 2010.

On June 15th, the Board of Directors of the Company authorized the repurchase up to $25 million of our common stock through the end of December 2012. Under the program the Company has repurchased approximately 363,000 shares of common stock.

There were approximately 59 million shares of common stock issued and outstanding as of December 31, 2011.

Conference Call

 

   Thursday, March 1, 2012 @ 10:30 a.m. Eastern/7:30 a.m. Pacific
   Domestic:   

(877) 837-3910, Conference ID# 50311145

  

International:

   (973) 796-5077, Conference ID# 50311145

On the conference call, management will review the financial results, provide an update on the Company’s business and discuss expectations for the future.

Key Catalysts For 2012

FUSILEV®

 

   

Continue to gain market share and grow revenue; and,

 

   

Initiate additional clinical studies to expand indications.

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


ZEVALIN®

 

   

Execute worldwide commercial strategy;

 

   

Initiate enrollment in the “ZEST” clinical study in Diffuse Large B-Cell Lymphoma; and,

 

   

Expand the “ZAR” head-to-head study vs. rituximab maintenance in follicular non-Hodgkin lymphoma.

Apaziquone

 

   

Results of pivotal registrational clinical trial, and

 

   

File NDA.

Belinostat

 

   

Results of pivotal registrational clinical trial, and

 

   

File NDA.

Robust Pipeline

 

   

Initiate a Phase 2 study for SPI-1620

 

   

Initiate a Phase 2 study for SPI-2012

 

   

Initiate a Phase I study for SPI-014 (f/k/a Renazorb)

About Spectrum Pharmaceuticals, Inc.

Spectrum Pharmaceuticals, a biotechnology company with a primary focus in oncology and hematology, currently markets two oncology drugs, FUSILEV® (levoleucovorin) for Injection and ZEVALIN® (ibritumomab tiuxetan) Injection for intravenous use. In addition, Spectrum has two drugs, apaziquone and belinostat, in late stage development with a goal of filing New Drug Applications (NDAs) with the U.S. Food & Drug Administration in 2012. The Company also has a diversified pipeline of novel drug candidates. The Company’s strategy is comprised of acquiring, developing and commercializing a broad and diverse pipeline of late-stage clinical and commercial drug products. The Company has aggressive business development and commercial operation teams that support a robust drug development program encompassing clinical development, medical research, regulatory affairs, biostatistics and data management. The Company also leverages the expertise of its worldwide partners to assist in the execution of its strategy. For more information, please visit the Company’s website at www.sppirx.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 are based on management’s current beliefs and expectations. These statements include but are not limited to statements that relate to our business and its future, including certain company milestones, Spectrum’s ability to identify, acquire, develop and commercialize a broad and diverse pipeline of late-stage clinical and commercial products, leveraging the expertise of partners and employees, around the world to assist us in the execution of our strategy, 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 applications to the FDA may not receive approval, 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 sustained revenue history, 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.®, ZEVALIN®, and FUSILEV® are registered trademarks of Spectrum Pharmaceuticals, Inc. REDEFINING CANCER CARE™ and the Spectrum Pharmaceutical logos are trademarks owned by Spectrum Pharmaceuticals, Inc.

© 2012 Spectrum Pharmaceuticals, Inc. All Rights Reserved.

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


Non-GAAP Financial Measures

The non-GAAP financial measures contained herein are a supplement to the corresponding financial measures prepared in accordance with generally accepted accounting principles (GAAP). The non-GAAP financial measures presented exclude the items summarized in the below table. Management believes that adjustments for these items assist investors in making comparisons of period-to-period operating results and that these items are not indicative of the Company’s on-going core operating performance.

Management uses non-GAAP net income (loss) in its evaluation of the Company’s core after-tax results of operations and trends between fiscal periods and believes that these measures are important components of its internal performance measurement process. Management believes that providing these non-GAAP financial measures allows investors to view the Company’s financial results in the way that management views the financial results.

The non-GAAP financial measures presented herein have certain limitations in that they do not reflect all of the costs associated with the operations of the Company’s business as determined in accordance with GAAP. Therefore, investors should consider non-GAAP financial measures in addition to, and not as a substitute for, or as superior to, measures of financial performance prepared in accordance with GAAP. The non-GAAP financial measures presented by the Company may be different from the non-GAAP financial measures used by other companies.

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments

(In thousands, except share and per share data)

(Unaudited)

 

September 30, September 30, September 30, September 30, September 30, September 30,
       Three Months Ended
December 31, 2011
     Three Months Ended
December 31, 2010
 
       GAAP      Non-GAAP
Adjustments
    Non-GAAP      GAAP      Non-GAAP
Adjustments
    Non-GAAP  

Revenues:

                 

Product sales, net

     $ 49,904       $ —        $ 49,904       $ 30,871       $ —        $ 30,871   

License and contract revenue

       3,075         —          3,075         3,075         —          3,075   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total revenues

     $ 52,979       $ —        $ 52,979       $ 33,946       $ —        $ 33,946   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Operating costs and expenses:

                 

Cost of product sales (excludes amortization of purchased intangible assets)

       10,283           10,283         6,813         —          6,813   

Selling, general and administrative

       25,292         (6,572 )(1)      18,720         12,475         (1,645 )(1)      10,830   

Research and development

       6,816         (449 )(1)      6,367         6,986         (373 )(1)      6,613   

Amortization of purchased intangibles

       930         —          930         930         —          930   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total operating costs and expenses

       43,321         (7,021     36,300         27,204         (2,018     25,186   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Income (loss) from operations

       9,658         7,021        16,679         6,742         2,018        8,760   

Change in fair value of common stock warrant liability

       —           —          —           (3,300      3,300 (2)      —     

Other income, net

       27         —          27         1,034         —          1,034   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Income (loss) before provision for income taxes

       9,685         7,021        16,706         4,476         5,318        9,794   

(Provision) benefit for income taxes

       (1,404      —          (1,404      (36      —          (36
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Net income (loss)

     $ 8,281       $ 7,021      $ 15,302       $ 4,440       $ 5,318      $ 9,758   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Net income (loss) per share:

                 

Basic

     $ 0.15         $ 0.27       $ 0.09         $ 0.19   
    

 

 

      

 

 

    

 

 

      

 

 

 

Diluted

     $ 0.13         $ 0.24       $ 0.08         $ 0.19   
    

 

 

      

 

 

    

 

 

      

 

 

 

Weighted average shares outstanding:

                 

Basic

       56,916,064           56,916,064         50,344,177           50,344,177   
    

 

 

      

 

 

    

 

 

      

 

 

 

Diluted

       63,313,226           63,313,226         52,268,739           52,268,739   
    

 

 

      

 

 

    

 

 

      

 

 

 

 

(1) Adjustment for stock-based compensation expense recognized in the period

 

(2) Add back the change in fair value of common stock warrant liability

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

Consolidated Statements of Operations and Reconciliation of Non-GAAP Adjustments

(In thousands, except share and per share data)

(Unaudited)

 

September 30, September 30, September 30, September 30, September 30, September 30,
       Twelve Months Ended
December 31, 2011
     Twelve Months Ended
December 31, 2010
 
       GAAP      Non-GAAP
Adjustments
    Non-GAAP      GAAP      Non-GAAP
Adjustments
    Non-GAAP  

Revenues:

                 

Product sales, net

     $ 180,663       $ —        $ 180,663       $ 60,921       $ —        $ 60,921   

License and contract revenue

       12,300         —          12,300         13,192         —          13,192   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total revenues

     $ 192,963       $ —        $ 192,963       $ 74,113       $ —        $ 74,113   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Operating costs and expenses:

                 

Cost of product sales (excludes amortization of purchased intangible assets)

       33,838         —          33,838         17,439         —          17,439   

Selling, general and administrative

       72,553         (20,609 )(1)      51,944         48,550         (5,801 )(1)      42,749   

Research and development

       27,720         (1,628 )(1)      26,092         57,301         (2,484 )(1)      54,817   

Amortization of purchased intangibles

       3,720         —          3,720         3,720         —          3,720   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Total operating costs and expenses

       137,831         (22,237     115,594         127,010         (8,285     118,725   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Income (loss) from operations

       55,132         22,237        77,369         (52,897      8,285        (44,612

Change in fair value of common stock warrant liability

       (3,488      3,488 (2)      —           2,731         (2,731 )(2)      —     

Other income, net

       577         —          577         1,279         —          1,279   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Income (loss) before provision for income taxes

       52,221         25,725        77,946         (48,887      5,554        (43,333

(Provision) benefit for income taxes

       (3,704      (1,896     (5,600      43         —          43   
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Net income (loss)

     $ 48,517       $ 23,829      $ 72,346       $ (48,844    $ 5,554      $ (43,290
    

 

 

    

 

 

   

 

 

    

 

 

    

 

 

   

 

 

 

Net income (loss) per share:

                 

Basic

     $ 0.91         $ 1.36       $ (0.99      $ (0.87
    

 

 

      

 

 

    

 

 

      

 

 

 

Diluted

     $ 0.84         $ 1.25       $ (0.99      $ (0.87
    

 

 

      

 

 

    

 

 

      

 

 

 

Weighted average shares outstanding:

                 

Basic

       53,272,767           53,272,767         49,502,854           49,502,854   
    

 

 

      

 

 

    

 

 

      

 

 

 

Diluted

       57,959,714           57,959,714         49,502,854           49,502,854   
    

 

 

      

 

 

    

 

 

      

 

 

 

 

(1) Adjustment for stock-based compensation expense recognized in the period

 

(2) Add back the change in fair value of common stock warrant liability

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI


SPECTRUM PHARMACEUTICALS, INC. AND SUBSIDIARIES

SUMMARY CONSOLIDATED BALANCE SHEETS

(In thousands)

(Unaudited)

 

September 30, September 30,
       December 31,
2011
       December 31,
2010
 

Cash and equivalents

       121,202           53,557   

Marketable securities

       40,060           42,117   

Accounts receivable, net

       51,703           21,051   

Inventories, net

       10,762           4,234   

Prepaid expenses and other current assets

       2,074           906   
    

 

 

      

 

 

 

Total current assets

       225,801           121,865   

Investments

       9,283           8,569   

Property and equipment, net

       2,681           3,158   

Intangible assets, net

       41,654           29,605   

Other assets

       1,361           434   
    

 

 

      

 

 

 

Total Assets

     $ 280,780         $ 163,631   
    

 

 

      

 

 

 

Current liabilities

     $ 78,537         $ 63,322   

Deferred revenue and other credits – less current portion

       14,029           25,495   

Other long-term liabilities

       307           338   
    

 

 

      

 

 

 

Total liabilities

       92,873           89,155   

Total stockholders’ equity

       187,907           74,476   
    

 

 

      

 

 

 

Total liabilities and stockholders’ equity

     $ 280,780         $ 163,631   
    

 

 

      

 

 

 

 

11500 S. Eastern Ave., Ste. 240 Ÿ Henderson, Nevada 89052 Ÿ Tel: 702-835-6300 Ÿ Fax: 702-260-7405

Ÿ www.sppirx.com Ÿ NASDAQ: SPPI