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8-K - FORM 8-K - DENDREON CORPd347374d8k.htm

Exhibit 99.1

 

LOGO

Dendreon Reports Net PROVENGE Product Revenues of $82 Million, Achieved 6.5%

Quarter-Over-Quarter Growth

— Conference Call to be Hosted May 7, 2012 at 4:30 p.m. ET/1:30 p.m. PT –

SEATTLE, May 7, 2012 — Dendreon Corporation (Nasdaq: DNDN) today reported results for the quarter ended March 31, 2012. Net product revenue for the quarter was $82.0 million compared to $27.0 million for the quarter ended March 31, 2011.

Net loss in the first quarter of 2012 was $103.9 million or $0.70 per share, compared to a net loss of $112.8 million, or $0.78 per share, for the same period in 2011. The current period results include approximately $17 million in cash and non-cash severance expenses. Excluding these expenses, the company had a net loss of $87.1 million or $0.59 per share.

As of March 31, 2012, Dendreon had approximately $559.1 million in cash, cash equivalents, and short-term and long-term investments compared to $617.7 million as of December 31, 2011.

Recent Highlights:

 

   

Increased demand for PROVENGE® (sipuleucel-T):

 

   

Added 128 new infusion sites in the first quarter, totaling 723 infusion sites since launch

 

   

Increased use of PROVENGE in large community oncology practices and community urology practices

 

   

Reimbursement landscape remains stable for physicians:

 

   

Reported average time to payment remains less than 30 days for physicians

 

   

Q-Code will remain in effect according to recent CMS preliminary decision

 

   

Launched urology key account managers

 

   

Announced executive appointments:

 

   

Joe DePinto, Executive Vice President, Global Commercial Operations

 

   

Christine Mikail, Executive Vice President, Corporate Development, General Counsel and Secretary

 

   

Robert S. Poulton, Executive Vice President, Technical Operations

“Dendreon continues to make significant progress in establishing PROVENGE as the foundation of care for men with advanced prostate cancer,” said John H. Johnson, president and chief executive officer. “We are pleased to have exceeded our guidance of low single digit quarter-over-quarter growth and the progress we have made in strengthening our commercial organization.”

Conference Call Information

Dendreon will host a conference call on Monday, May 7, 2012 at 4:30 p.m. ET. To access the live call, dial 1-877-548-9590 (domestic) or +1-720-545-0037 (international); the conference ID number is 70198839. The call will also be audio webcast and will be available from the Company’s website at http://www.dendreon.com under the “Investor/Webcasts and Presentations” section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-800-585-8367 or +1-404-537-3406 for international callers; the conference ID number is 70198839. The replay will be available from 7:30 p.m. EDT on Monday, May 7, until 11:59 p.m. EDT on Monday, May 14. In addition, the webcast will be archived for on-demand listening for 90 days at www.dendreon.com .


About Dendreon

Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development, commercialization and manufacturing of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy (ACI) product candidates designed to stimulate an immune response in a variety of tumor types. Dendreon’s first product, PROVENGE® (sipuleucel-T), was approved by the U.S. Food and Drug Administration (FDA) in April 2010. Dendreon is exploring the application of additional ACI product candidates and small molecules for the potential treatment of a variety of cancers. The Company is headquartered in Seattle, Washington and is traded on the NASDAQ Global Market under the symbol DNDN. For more information about the Company and its programs, visit http://www.dendreon.com/.

This news release contains forward-looking statements that are subject to risks and uncertainties. Factors that could affect these forward-looking statements include, but are not limited to, developments affecting Dendreon’s business and prospects and potential revenue and earnings from product sales, and progress generally on commercialization efforts for PROVENGE. Information on the factors and risks that could affect Dendreon’s business, financial condition and results of operations are contained in Dendreon’s public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. Dendreon cautions investors not to place undue reliance on the forward-looking statements contained in this press release. All forward-looking statements are based on information currently available to Dendreon on the date hereof, and Dendreon undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law.

Contact:

Dendreon Corporation

Nicole Soley

Investor Relations

206-455-2220

InvestorRelations@dendreon.com


DENDREON CORPORATION

CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except per share amounts)

 

     Three Months Ended
March 31,
 
     2012     2011  
     (unaudited)  

Product revenue, net

   $ 81,972      $ 27,001   

Royalty and other revenue

     102        21   
  

 

 

   

 

 

 

Total revenue

     82,074        27,022   

Operating expenses:

    

Cost of product revenue

     60,041        18,338   

Research and development

     17,343        17,609   

Selling, general and administrative

     95,315        95,289   

Restructuring

     (124     —     
  

 

 

   

 

 

 

Total operating expenses

     172,575        131,236   
  

 

 

   

 

 

 

Loss from operations

     (90,501     (104,214

Interest income

     383        400   

Interest expense

     (13,812     (8,993

Other income

     16        —     
  

 

 

   

 

 

 

Net loss

   $ (103,914   $ (112,807
  

 

 

   

 

 

 

Basic and diluted net loss per share

   $ (0.70   $ (0.78
  

 

 

   

 

 

 

Shares used in computation of basic and diluted net loss per share

     147,599        145,494   
  

 

 

   

 

 

 
     March 31,
2012
    December 31,
2011
 

Balance Sheet Data:

    

Cash and cash equivalents

   $ 337,661      $ 427,100   

Short-term investments

     159,879        111,525   

Long-term investments

     61,554        79,071   

Trade accounts receivable

     41,657        35,541   

Prepaid antigen costs

     4,417        7,490   

Inventory

     73,968        69,502   

Total assets

     941,958        1,001,491   

Convertible senior notes due 2016

     514,316        508,418   

Convertible senior subordinated notes due 2014

     27,685        27,685   

Total stockholders’ equity

     279,526        352,637   


DENDREON CORPORATION

RECONCILIATION OF GAAP TO NON-GAAP NET LOSS

(in thousands, except per share amounts)

 

     Three Months Ended
March 31,
 
     2012     2011  
     (unaudited)  

GAAP net loss

   $ (103,914   $ (112,807

Non-GAAP adjustments:

    

Depreciation and amortization expense

     10,864        7,311   

Imputed interest related to the convertible senior notes due 2016

     5,898        4,300   

Restructuring

     (124     —     

Management severance and other termination benefits:

    

Severance expense

     5,173        —     

Non-cash stock-based compensation expense

     11,678        —     

Other stock-based compensation expense

     19,475        14,676   
  

 

 

   

 

 

 

Non-GAAP net loss

   $ (50,950   $ (86,520
  

 

 

   

 

 

 

Non-GAAP net loss per share- basic and diluted

   $ (0.35   $ (0.59
  

 

 

   

 

 

 

Shares used in computation of basic and diluted net loss per share

     147,599        145,494   
  

 

 

   

 

 

 

The above table provides certain non-GAAP financial measures that include adjustments to GAAP figures. Dendreon believes that these non-GAAP financial measures, when considered together with the GAAP figures, can enhance an overall understanding of Dendreon’s financial performance and its prospects for the future. The non-GAAP financial measures are included with the intent of providing investors with a more complete understanding of operational results and trends. We believe excluding these non-cash items provides important insight into our operational results, important for a company at our stage in development. In addition, these non-GAAP financial measures are among the indicators Dendreon management uses for planning and forecasting purposes and measuring the Company’s performance. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP figures.