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Cerus Corporation Reports Third Quarter 2012 Results

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 revenue guidance, future operating expenses and cash used to support operations, statements relating to the planned submission of a modular PMA to the FDA for the INTERCEPT Blood System for plasma, including the timing thereof, the sufficiency of existing clinical data to enable a modular PMA submission and the possibility of obtaining an early resolution of PMA deficiencies if identified by the FDA, prospects for regulatory approvals of the Company’s products and other future regulatory matters, and statements relating to planned preparation and initiation of clinical trials and the timing thereof, 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 planned clinical trials for the INTERCEPT Blood System for red blood cells may not occur on the timeframe discussed herein or otherwise in a timely manner, or at all, that Cerus may be unable to reach agreement with the FDA on the planned modular PMA submission for the INTERCEPT Blood System for plasma or may be required to conduct additional clinical development of the plasma system, and that if additional clinical development of the plasma system is required it may be impractical to perform or require funding that Cerus does not currently have, 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 June 30, 2012 filed with the SEC on August 8, 2012. Cerus disclaims any obligation or undertaking to update or revise any forward-looking statements contained in this press release.

CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATIONS

(in thousands except per share information)

 
Three Months Ended

September 30,

Nine Months Ended

September 30,

  2012       2011     2012       2011  
Revenue:
Product revenue $ 8,252 $ 7,770 $ 26,167 $ 20,706
Government grant and cooperative agreements   --     1,479     91     1,915  
Total revenue 8,252 9,249 26,258 22,621
 
Cost of product revenue   4,411     4,726     15,499     12,329  
Gross profit 3,841 4,523 10,759 10,292
 
Operating expenses:
Research and development 1,903 1,814 5,439 5,616
Selling, general and administrative 6,219 5,380 18,871 17,115
Amortization of intangible assets   50     51     151     152  
Total operating expenses   8,172     7,245     24,461     22,883  
Loss from operations (4,331 ) (2,722 ) (13,702 ) (12,591 )
Non-operating income (expense), net   871     4,982     (499 )   3,344  
 
Net income (loss) $ (3,460 ) $ 2,260   $ (14,201 ) $ (9,247 )
 
Net income (loss) per common share:
Basic $ (0.06 ) $ 0.05 $ (0.26 ) $ (0.19 )
Diluted $ (0.08 ) $ 0.05 $ (0.26 ) $ (0.19 )
 

Weighted average common shares outstanding used for

 

 

 

 

computing net income (loss) per common share:

Basic 54,875 47,710 54,130 47,600
Diluted 55,377 48,820 54,130 47,600

CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED BALANCE SHEETS

(in thousands)

     

 

September 30,

2012

December 31,

2011

 
Cash, cash equivalents, and short-term investments

$

26,661

$

25,784

Accounts receivable and other current assets 7,193 7,511
Inventories 9,682 6,444
Property and equipment, net 1,801 2,032
Goodwill and intangible assets 2,913 3,064
Other assets   403   532
Total assets $ 48,653 $ 45,367
 
Accounts payable and accrued liabilities $ 13,787 $ 10,505
Deferred revenue 716 111
Debt - current 4,919 2,519
Warrant liability 7,876 7,979
Debt - non-current 3,307 4,697
Other non-current liabilities   1,132   1,243
Total liabilities 31,737 27,054
Stockholders’ equity   16,916   18,313
Total liabilities and stockholders’ equity $ 48,653 $ 45,367




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