-----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, SRuMvm9ETri91CwP5G8kxyeH7q4bUYh1dio5iadR7/1JpEqtCK1iyfPA2z7N0XyH KKoeMy+mDS0xrScSp7dx9Q== 0001193125-10-037574.txt : 20100223 0001193125-10-037574.hdr.sgml : 20100223 20100223160652 ACCESSION NUMBER: 0001193125-10-037574 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100223 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100223 DATE AS OF CHANGE: 20100223 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CERUS CORP CENTRAL INDEX KEY: 0001020214 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 680262011 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21937 FILM NUMBER: 10626036 BUSINESS ADDRESS: STREET 1: 2411 STANWELL DR CITY: CONCORD STATE: CA ZIP: 94520 BUSINESS PHONE: 9252886000 MAIL ADDRESS: STREET 1: 2525 STANWELL DRIVE STREET 2: STE 300 CITY: CONCORD STATE: CA ZIP: 94520 FORMER COMPANY: FORMER CONFORMED NAME: CERUS TECHNOLOGIES INC DATE OF NAME CHANGE: 19960731 8-K 1 d8k.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): February 23, 2010

 

 

CERUS CORPORATION

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   0-21937   68-0262011

(State or other jurisdiction

of incorporation)

  (Commission File No.)  

(IRS Employer

Identification No.)

2411 Stanwell Drive

Concord, California 94520

(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (925) 288-6000

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 (see General Instruction A.2. below):

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


Item 2.02. Results of Operations and Financial Condition.

On February 23, 2010, Cerus Corporation (the “Company”) announced its financial results for its fourth quarter and year ended December 31, 2009. A copy of the Company’s press release, entitled “Cerus Announces Fourth Quarter and Year-End 2009 Results,” is furnished pursuant to Item 2.02 as Exhibit 99.1 hereto.

The information in this report, including the exhibit hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of Section 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information contained herein and in the accompanying exhibit shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by the Company, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

99.1   Press Release, dated February 23, 2010, entitled “Cerus Announces Fourth Quarter and Year-End 2009 Results.”


SIGNATURE

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.

 

  CERUS CORPORATION
Dated: February 23, 2010   By:  

/s/    KEVIN D. GREEN        

    Kevin D. Green
    Vice President, Finance and Chief Accounting Officer


EXHIBIT INDEX

 

Exhibit
Number

  

Description

99.1

   Press Release, dated February 23, 2010, entitled “Cerus Announces Fourth Quarter and Year-End 2009 Results.”
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

LOGO

 

Contact:  
Kevin D. Green   Jason Spark
Vice President, Finance & CAO   Porter Novelli Life Sciences
Cerus Corporation   (619) 849-6005
(925) 288-6138  

CERUS ANNOUNCES FOURTH QUARTER AND YEAR-END 2009 RESULTS

 

   

Annual Revenues Up 9% and Quarterly Revenues Up 51% from 2008

 

   

Annual Operating Expenses Down 22%

CONCORD, Calif.—(BUSINESS WIRE)—February 23, 2010—Cerus Corporation (NASDAQ: CERS) announced today financial results for the fourth quarter and year ended December 31, 2009.

Total revenue for the year ended December 31, 2009, was $18.0 million, an increase of 9% from $16.5 million for 2008. Product revenue for the INTERCEPT Blood System increased to $16.8 million during 2009, up 8% from $15.5 million during 2008 when approximately $1.5 million in previously deferred product revenue was recognized. Growth in 2009 was driven by increased penetration in new and existing markets, primarily France, Belgium and Southern Europe. The Company also recognized $1.2 million in government grant revenue supporting the ongoing development of the red blood cell system during 2009, slightly more than the $1.0 million recognized during 2008.

Cost of product revenue was $12.6 million for the year ended December 31, 2009, up from $9.7 million for 2008. Gross margins on product sales were 25% in 2009, down from 38% in 2008. Lower manufacturing volumes added approximately 15% to the cost of product revenue for 2009. Although reduced manufacturing volumes temporarily eroded margins, the Company has been able to tighten inventory levels and conserve cash.

Total operating expenses for 2009 were $29.2 million, down 22% from $37.4 million in 2008. The decrease in our 2009 operating expenses from 2008 is due to operating under a lower cost structure as a result of implementing the


previously announced restructuring plan. Operating expenses in 2009 included non-recurring restructuring charges of $0.8 million, non-cash impairment charges of $2.3 million associated with a write-down of the Company’s investment in BioOne Corporation, gains of $0.8 million associated with the disposition of the Company’s investment in Anza Therapeutics, Inc. and gains of $1.4 million resulting from a settlement reached with Baxter regarding the 2006 transition of the commercialization rights associated with the Company’s INTERCEPT Blood System.

Net loss for 2009 was $24.1 million, or $0.69 per share, compared to $29.2 million, or $0.90 per share in 2008.

Total revenue for the three months ended December 31, 2009, was $5.5 million, up from $3.6 million during the same period in 2008. Fourth quarter 2009 product revenue was $5.2 million, up 48% from the $3.5 million recognized during the fourth quarter of 2008, driven primarily by an increase in disposable kit sales. Fourth quarter 2009 product revenue represented the most successful quarter that the Company has had since commercializing the INTERCEPT platelet and plasma systems. Government grant revenue for the fourth quarter of 2009 was $0.2 million, compared to $0.1 million recognized during the same period in 2008.

Cost of product sales was $3.7 million in the fourth quarter of 2009, compared to $3.0 million during the same period in 2008. Gross margins from product sales were 29% during the fourth quarter of 2009, compared to 16% during the same period in 2008.

Total operating expenses for the fourth quarter of 2009 were $6.7 million, down 15% from $7.8 million during the fourth quarter of 2008. In addition to the non-recurring charges, fourth quarter 2009 operating expenses included research and development expenses of $1.5 million and selling, general and administrative expenses of $5.0 million, compared to research and development expenses of $2.3 million and selling, general and administrative expenses of $5.6 million in the fourth quarter of 2008. The decrease in R&D and SG&A operating expenses is due to the effects of the Company’s 2009 restructuring plan.

 

2


Net loss for the fourth quarter of 2009 was $4.9 million, compared to a net loss of $6.5 million for the fourth quarter of 2008. Net loss per share was $0.13 for the fourth quarter of 2009, compared to a loss of $0.20 per share for the same period of 2008.

At December 31, 2009, the Company had cash and marketable securities of $19.9 million. Net cash used during the fourth quarter of 2009 was $2.7 million, consistent with net cash used during the second and third quarters of 2009. Net cash used during 2009 was $2.6 million, compared to $34.3 million in 2008.

“We closed the year strong with our best quarter of INTERCEPT revenue ever, achieving our fourth consecutive year of sales growth,” said Claes Glassell, president and chief executive officer of Cerus Corporation.

Recent Developments:

 

 

Positive outcome from the TESSI study demonstrating that INTERCEPT-treated platelets remain therapeutically effective at seven days of storage, confirming the logistical advantages of INTERCEPT-treated platelets over conventional platelets;

 

 

Successful completion of the Phase I clinical trial of the red blood cell system, which met its primary endpoint; and

 

 

Collaboration agreement for the development of the INTERCEPT red blood cell system with the French National Blood Service, the Etablissement Francais du Sang.

 

3


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://investor.cerus.com. Alternatively, you may access the live conference call by dialing 877-407-0782 (U.S.) or 201-689-8567 (international).

A replay will be available on the Cerus web site, or by dialing 877-660-6853 (U.S.) or 201-612-7415 (international) and entering account number 286 and conference ID number 300292. The replay will be available approximately two hours after the call through March 9, 2010.

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 allows INTERCEPT treatment to inactivate both established transfusion threats, such as hepatitis, HIV, West Nile virus and bacteria, as well as emerging pathogens such as influenza, malaria and dengue. Cerus currently markets and sells the INTERCEPT Blood System for both platelets and plasma in Europe, Russia, the Middle East and selected countries in other regions around the world. The INTERCEPT red blood cell system is in clinical development. See http://www.cerus.com for more information.

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

 

4


LOGO

CERUS CORPORATION

CONDENSED CONSOLIDATED UNAUDITED STATEMENTS OF OPERATION

(In thousands except per share information)

 

     Three Months Ended
December 31,
    Twelve Months Ended
December 31,
 
     2009     2008     2009     2008  

Revenue

        

Product revenue

   $ 5,228      $ 3,541      $ 16,751      $ 15,518   

Government grant and cooperative agreements

     246        85        1,231        989   
                                

Total Revenue

     5,474        3,626        17,982        16,507   
                                

Cost of product revenue

     3,724        2,964        12,580        9,668   
                                

Gross profit

     1,750        662        5,402        6,839   

Operating expenses

        

Research and development

     1,505        2,268        6,372        10,205   

Selling, general and administrative

     5,017        5,557        21,867        27,164   

Restructuring

     (15     —          841        —     

Loss of long-term investments, net

     1,536        —          1,536        —     

Gain on settlement

     (1,381     —          (1,381     —     
                                

Total operating expenses

     6,662        7,825        29,235        37,369   
                                

Loss from operations

     (4,912     (7,163     (23,833     (30,530

Interest and other income (expense), net

     23        649        (302     1,349   
                                

Net loss

   $ (4,889   $ (6,514   $ (24,135   $ (29,181
                                

Net loss per share – basic and diluted

   $ (0.13   $ (0.20   $ (0.69   $ (0.90

Weighted average common shares outstanding used for basic and diluted loss per share

        

Basic

     38,680        32,540        34,750        32,430   

Diluted

     38,680        32,540        34,750        32,430   

 

5


LOGO

Cerus Corporation

Condensed Consolidated Unaudited Balance Sheets

(In thousands)

 

     December 31,
2009
   December 31,
2008

Cash, cash equivalents, and short-term investments

   $ 19,931    $ 22,578

Accounts receivable and other current assets

     4,721      8,356

Inventories

     7,707      11,109

Property and equipment, net

     1,217      1,844

Other assets

     915      3,452
             

Total Assets

   $ 34,491    $ 47,339
             

Accounts payable and accrued liabilities

   $ 9,709    $ 12,453

Deferred revenue

     345      445

Warrant liability

     2,737      —  

Accrued restructuring

     113      —  

Other current liabilities

     9      —  

Other long-term liabilities

     130      163
             

Total liabilities

     13,043      13,061
             

Stockholders’ equity

     21,448      34,278
             

Total liabilities and stockholders’ equity

   $ 34,491    $ 47,339
             

 

6

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