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8-K - FORM 8-K - CERUS CORPd390538d8k.htm

Exhibit 99.1

 

LOGO

Contact:

Kevin D. Green

Vice President, Finance & CAO

Cerus Corporation

(925) 288-6138

Cerus Corporation Reports Second Quarter 2012 Results

CONCORD, CA, August 2, 2012 - Cerus Corporation (NASDAQ: CERS) today announced financial results for the second quarter ended June 30, 2012.

Second quarter 2012 results:

 

   

Revenue of $9.2 million, a 37% increase from the second quarter of 2011;

 

   

Operating expenses of $8.4 million compared to $8.3 million incurred during the second quarter of 2011; and

 

   

Cash of $26.7 million at June 30, 2012 compared to $31.5 million at March 31, 2012 and $25.8 million at December 31, 2011.

First half 2012 results:

 

   

Total revenue of $18.0 million, a 35% increase from the first half of 2011;

 

   

Product revenue of $17.9 million, a 38% increase from the first half of 2011; and

 

   

Operating expenses of $16.3 million compared to $15.6 million incurred during the first half of 2011.

“Cerus continued to deliver strong growth during the second quarter, with increased demand for INTERCEPT disposable kits,” said William ‘Obi’ Greenman, president and chief executive officer of Cerus Corporation. “We reiterate our 2012 guidance for revenue of $34 million to $36 million. We continue to make encouraging progress within our red blood cell program and we expect to initiate our Phase III acute anemia trial in Europe in the third quarter, the first of two European Phase III studies planned to start this year.”

Revenue

Revenue for the second quarter of 2012 was $9.2 million, derived entirely from product sales. These revenues represent a 37% increase from the $6.8 million recognized during second quarter of 2011. The increase in revenue was driven primarily by a 37% increase in year-over-year demand for INTERCEPT disposable kits.

Total revenue for the first half of 2012 was $18.0 million, up from the $13.4 million recognized during the first half of 2011. Product revenue for the first half of 2012 was $17.9 million, and represented a 38% increase from the first half of 2011. The increase in product revenue during the first half of 2012 over 2011 was driven primarily by a 46% increase in demand for INTERCEPT disposable kits.

Government grant revenue for the first half of 2012 was $0.1 million, down from $0.4 million recognized during the first half of 2011. The availability of government grants awarded to Cerus in support of the Company’s red blood cell system has been fully exhausted. The Company does not currently expect any incremental government grant revenue during the second half of 2012.


Gross Margins

Gross margins for the second quarter of 2012 were 40%, equivalent to gross margins reported for the second quarter of 2011. Gross margins for the first half of 2012 were 38%, compared to 43% for same period in 2011. Gross margins during the first half of 2012 were affected by the mix of products sold and, during the first quarter of 2012, were negatively impacted by accounting charges associated with high scrap rates for certain components used to make INTERCEPT disposable kits.

Operating Expenses

Total operating expenses for the second quarter of 2012 were $8.4 million, compared to $8.3 million for the second quarter of 2011. Total operating expenses for the first half of 2012 were $16.3 million, compared to $15.6 million for the first half of 2011. The increase in operating expenses was related to increases in selling, general and administrative expenses in support of the growing commercial business in Europe, the Middle East, The Commonwealth of Independent States and the expansion into new markets and geographies. Operating expenses are expected to increase during the second half of 2012 and into 2013, driven by increased research and development expenses associated with the planned clinical trials and in-vitro studies to support potential regulatory approval of the INTERCEPT red blood cell system.

Operating and Net Loss

Operating losses during the second quarter of 2012 were improved from those incurred during the same period in 2011. The improvement in operating losses was attributable to the growth in revenue, stable gross margins, and relatively consistent operating expenses during the two comparative periods. Operating losses for the first half of 2012 were also improved from operating losses incurred during the first half of 2011, primarily due to the increase in product revenue.

Net loss for the second quarter of 2012 was $1.9 million, or $0.10 per diluted share, compared to a net loss of $6.4 million, or $0.13 per diluted share, for the second quarter of 2011. The change in net loss was primarily affected by a second quarter 2012 non-cash gain of $3.7 million compared to a similar charge of $0.3 million for the same period in 2011, resulting from the mark-to-market adjustments of Cerus’ outstanding warrants. Net loss for the first half of 2012 was $10.7 million, or $0.20 per diluted share, compared to a net loss of $11.5 million, or $0.24 per diluted share, for the first half of 2011.

Cash and Investments

At June 30, 2012, the Company had cash, cash equivalents and short-term investments of $26.7 million, up from $25.8 million at December 31, 2011. Cash payments to vendors for the increase in inventory during the first half of 2012 were a significant contributing factor in the amount of net cash used during the quarter.

OTHER RECENT PROGRESS:

 

   

Preliminary regulatory reviews of the clinical trial applications for the planned INTERCEPT red cell Phase III acute anemia have been completed in France and Germany; enrollment is anticipated to begin in the third quarter.

 

   

Preparations continue for future expected initiation of the planned Phase III red cell chronic anemia trial in Italy, and the planned U.S. Phase II red cell study.

 

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QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview. To access the live webcast, please visit the Investor Relations page of the Cerus web site at http://www.cerus.com/Investors/Investor-Overview. Alternatively, you may access the live conference call by dialing 866-235-9006 (U.S.) or 631-291-4549 (international).

A replay will be available on the company’s web site, or by dialing 855-859-2056 (U.S.) or 404-537-3406 (international) and entering conference ID number 63119152. The replay will be available approximately three hours after the call through August 16, 2012.

ABOUT CERUS

Cerus Corporation is a biomedical products company focused on commercializing the INTERCEPT Blood System to enhance blood safety. The INTERCEPT system is designed to reduce the risk of transfusion-transmitted diseases by inactivating a broad range of pathogens such as viruses, bacteria and parasites that may be present in donated blood. The nucleic acid targeting mechanism of action enables INTERCEPT treatment to inactivate established transfusion threats, such as hepatitis B and C, HIV, West Nile virus and bacteria, and is designed to inactivate emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, the Commonwealth of Independent States, the Middle East and selected countries in other regions around the world. The INTERCEPT Blood System for red blood cells is in clinical development. See http://www.cerus.com for more information.

INTERCEPT and the INTERCEPT Blood System are trademarks of Cerus Corporation.

Forward-Looking Statements

Except for the historical statements contained herein, this press release contains forward-looking statements concerning Cerus’ products, prospects and results, including statements concerning Cerus’ expectations regarding its 2012 revenues, future operating expenses and cash used to support operations, statements relating to potential regulatory approvals and other future regulatory matters, and statements relating to planned preparation, initiation and enrollment of clinical trials and the future development of the INTERCEPT Blood System for red blood cells. Actual results could differ materially from these forward-looking statements as a result of certain factors, including, without limitation, risks associated with the commercialization and market acceptance of, and customer demand for, the INTERCEPT Blood System, the uncertain and time-consuming clinical development and regulatory process, including the risks that Cerus may be unable to initiate planned clincial trials for the INTERCEPT Blood System for red blood cells in the timeframe expressed herein or otherwise in a timely manner, or at all, adverse market and economic conditions, adverse fluctuations in foreign exchange rates, Cerus’ reliance on third parties to market, sell, distribute and maintain its products, Cerus’ ability to maintain an effective manufacturing supply chain, intellectual property protection, as well as other risks detailed in Cerus’ filings with the Securities and Exchange Commission, including Cerus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2012 filed with the SEC on May 7, 2012. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

Financial Tables Attached

 

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CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands except per share information)

 

     Three Months Ended
June 30,
    Six Months Ended
June 30,
 
     2012     2011     2012     2011  

Revenue:

        

Product revenue

   $ 9,224      $ 6,753      $ 17,915      $ 12,936   

Government grant and cooperative agreements

     —          —          91        436   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total revenue

     9,224        6,753        18,006        13,372   

Cost of product revenue

     5,574        4,074        11,088        7,603   
  

 

 

   

 

 

   

 

 

   

 

 

 

Gross profit

     3,650        2,679        6,918        5,769   

Operating expenses:

        

Research and development

     1,712        1,994        3,536        3,802   

Selling, general and administrative

     6,686        6,207        12,652        11,735   

Amortization of intangible assets

     51        51        101        101   
  

 

 

   

 

 

   

 

 

   

 

 

 

Total operating expenses

     8,449        8,252        16,289        15,638   
  

 

 

   

 

 

   

 

 

   

 

 

 

Loss from operations

     (4,799     (5,573     (9,371     (9,869

Non-operating income (expense), net

     2,892        (836     (1,370     (1,638
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss

   $ (1,907   $ (6,409   $ (10,741   $ (11,507
  

 

 

   

 

 

   

 

 

   

 

 

 

Net loss per common share:

        

Basic

   $ (0.04   $ (0.13   $ (0.20   $ (0.24

Diluted

   $ (0.10   $ (0.13   $ (0.20   $ (0.24

Weighted average common shares outstanding used for computing net loss per common share:

        

Basic

     54,418        47,620        53,753        47,530   

Diluted

     55,236        47,620        53,753        47,530   

 

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CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

 

     June 30,
2012
     December 31,
2011
 

Cash, cash equivalents, and short-term investments

   $  26,667       $  25,784   

Accounts receivable and other current assets

     4,749         7,511   

Inventories

     9,373         6,444   

Property and equipment, net

     1,866         2,032   

Goodwill and intangible assets

     2,963         3,064   

Other assets

     445         532   
  

 

 

    

 

 

 

Total assets

   $ 46,063       $ 45,367   
  

 

 

    

 

 

 

Accounts payable and accrued liabilities

   $ 10,083       $ 10,505   

Deferred revenue

     136         111   

Debt - current

     3,692         2,519   

Warrant liability

     8,749         7,979   

Debt - non-current

     3,717         4,697   

Other non-current liabilities

     1,167         1,243   
  

 

 

    

 

 

 

Total liabilities

     27,544         27,054   

Stockholders’ equity

     18,519         18,313   
  

 

 

    

 

 

 

Total liabilities and stockholders’ equity

   $ 46,063       $ 45,367   
  

 

 

    

 

 

 

 

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