-----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, CAlMtbBUv+vXirIi+7JC7MPXNZFt/vrJA+u6T7wrcdmRDZftQWwMTgY/CvufYqoa fMAiqMInyOOXN+8Y14Dzfg== 0001193125-07-131347.txt : 20070607 0001193125-07-131347.hdr.sgml : 20070607 20070607092440 ACCESSION NUMBER: 0001193125-07-131347 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20070607 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070607 DATE AS OF CHANGE: 20070607 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIGEN CORP CENTRAL INDEX KEY: 0000730272 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 042729386 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-14656 FILM NUMBER: 07905490 BUSINESS ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 BUSINESS PHONE: 7814499560 MAIL ADDRESS: STREET 1: 41 SEYON STREET STREET 2: BUILDING 1, SUITE 100 CITY: WALTHAM STATE: MA ZIP: 02453 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): June 7, 2007

 


Repligen Corporation

(Exact name of registrant as specified in charter)

 


 

Delaware   0-14656   04-2729386

(State or Other Jurisdiction

of Incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

41 Seyon Street, Bldg. 1, Suite 100, Waltham, MA 02453

(Address of Principal Executive Offices) (Zip Code)

(781) 250-0111

(Registrant’s telephone number, including area code)

 


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 June 7, 2007, Repligen Corporation announced its financial results for the fourth quarter and fiscal year 2007, ended March 31, 2007. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K.

The information in this Form 8-K and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.  

Description

99.1   Press Release dated June 7, 2007.

 

1


SIGNATURES

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.

 

  By:   Repligen Corporation
Date: June 7, 2007   By:  

/s/ Walter C. Herlihy

    Walter C. Herlihy
    President and Chief Executive Officer


EXHIBIT INDEX

 

Exhibit No.  

Exhibit

99.1   Press Release, dated June 7, 2007
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

RepliGen

   

Repligen Corporation

41 Seyon Street

Building #1, Suite 100

Waltham, Massachusetts 02453

Telephone: 781-250-0111

Telefax: 781-250-0115

FOR IMMEDIATE RELEASE    

CONTACT:

Walter C. Herlihy, Ph.D.

President and Chief Executive Officer

(781) 419-1900

   

Laura Whitehouse

VP Market Development

(781) 419-1812

Repligen Reports Fourth Quarter and Fiscal Year 2007 Financial Results

WALTHAM, MA June 7, 2007 – Repligen Corporation (NASDAQ: RGEN) today reported results for the fourth quarter and fiscal year 2007, ended March 31, 2007. Total revenue for fiscal year 2007 was $14,074,000 compared to total revenue of $12,911,000 for the fiscal year ended March 31, 2006, an increase of $1,163,000 or 9%. Total revenue for the year consisted primarily of Protein A and SecreFlo® product revenue and research revenue. Gross profit on product revenue for fiscal year 2007 was $9,459,000 (72%) compared to $8,978,000 (72%) for fiscal year 2006.

Operating expenses for the fiscal year ended March 31, 2007 were $15,899,000 compared to $14,131,000 in fiscal year 2006. This increase in operating expenses of $1,768,000 was primarily the result of increased clinical trial expenses, increased personnel and stock-based compensation expenses, which were offset by decreased external research expenses. The Company adopted Statement of Financial Accounting Standards No. 123R as of April 1, 2006. As a result, the Company recorded compensation expense for stock options awarded to employees in its Statement of Operations in fiscal year 2007. The total stock compensation expense recorded for the year ended March 31, 2007 was $837,000.

The net loss for fiscal year 2007 was $889,000 or $.03 per share, compared to a net profit for fiscal year 2006 of $697,000 or $.02 per share. Cash and marketable securities as of March 31, 2007 were $22,627,000 compared to $23,408,000 as of March 31, 2006.

“Our results for fiscal year 2007 are consistent with our goal to build a self-sustaining, integrated biopharmaceutical company,” stated Walter C. Herlihy, President and Chief Executive Officer of Repligen Corporation. “We continue to execute on our strategy to build shareholder value through prudent business management in which the growing profits from current product sales enable us to develop our intellectual property and our pipeline of drug candidates without many of the financial risks typically associated with an emerging biotech company.”

Total revenue for the fourth quarter of fiscal year 2007 was $3,699,000 compared to $2,885,000 for the same period in fiscal year 2006, an increase of 28%. Gross profit on product revenue for the fourth quarter of fiscal year 2007 was $2,495,000 (73%) compared to $1,955,000 (69%) for the fourth quarter of fiscal year 2006. Operating expenses for the fourth quarter of fiscal year 2007 were $4,050,000 compared to $3,899,000, for the fourth quarter of fiscal year 2006. The net loss for the fourth quarter of fiscal year 2007 was $107,000 or $.00 per share, compared to a net loss of $820,000 or $.03 per share for the fourth quarter of fiscal year 2006.


Corporate Update

Secretin for Imaging of the Pancreas

In May, we reported positive results from a Phase 2 clinical trial to evaluate the use of RG1068, synthetic human secretin, as an agent to improve the assessment of pancreatic duct structures by magnetic resonance imaging (MRI). The study showed an improvement in sensitivity of detection of structural abnormalities of the pancreatic duct of approximately 20% with no loss in specificity, consistent with prior data and expectations. In addition, the study showed highly significant increases in the following three assessments: physician confidence in their ability to identify structural abnormalities, the number of pancreatic duct segments visualized and improvement in the overall quality of the MRI images. Detailed visual assessment of the pancreatic ducts and identification of structural abnormalities is important in the assessment, diagnosis and treatment of diseases such as acute and chronic pancreatitis.

Uridine for Bipolar Depression

We are currently conducting a Phase 2 clinical trial of RG2417, an oral formulation of uridine, in bipolar depression. This is a multi-center study in which approximately 80 patients will receive an oral formulation of uridine or a placebo for 6 weeks. We have completed enrollment in this study and we expect to have results in the fall.

Transcription Activators for Friedreich’s Ataxia

In April, we entered into an exclusive commercial license with The Scripps Research Institute for intellectual property covering compounds, which may have utility in treating Friedreich’s ataxia. Friedreich’s ataxia is an inherited neurodegenerative disease in which low levels of the protein frataxin result in progressive damage to the nervous system and loss of muscle function. Research in tissues derived from patients as well as in mice indicates that the licensed compounds increase production of the protein frataxin, which suggests potential utility of these compounds in slowing or stopping progression of the disease. There is currently no treatment for Friedreich’s ataxia.

Commercial Products

In June, we announced that we have expanded our longstanding relationship with Applied Biosystems by entering into a four-year supply agreement for recombinant Protein A. Repligen is the world’s leading supplier of recombinant Protein A, a consumable used in the manufacture of monoclonal antibodies, the largest and fastest growing class of drug in the biopharmaceutical industry.

Quarterly Conference Call

Walter C. Herlihy, Ph.D., will host a conference call and webcast on Thursday, June 7th at 11:00 a.m. EDT, to review fourth quarter and fiscal year 2007 financial results and to provide a quarterly update of the Company. This call can be accessed via Repligen’s website at www.repligen.com or you may listen to the live broadcast by calling (866) 831-6234 for domestic calls and (617) 213-8854 for international calls. Participants must provide the following passcode: 86421181.

About Repligen Corporation

Repligen Corporation is a biopharmaceutical company focused on the development of novel therapeutics for diseases that affect the central nervous system. In addition, we are the world’s leading supplier of recombinant Protein A, the sales of which partially fund the advancement of our development pipeline while supporting our financial stability. Repligen’s corporate headquarters are located at 41 Seyon Street, Building #1, Suite 100, Waltham, MA 02453. Additional information may be requested from www.repligen.com.

 

-more-


SELECTED FINANCIAL DATA

 

Operating Statement Data:

  
    

Three months ended

March 31,

   

Years ended

March 31,

 
     2007     2006     2007     2006  

Revenue:

        

Product revenue

   $ 3,397,000     $ 2,843,000     $ 13,074,000     $ 12,529,000  

Other revenue

     302,000       42,000       1,000,000       382,000  
                                

Total revenue

     3,699,000       2,885,000       14,074,000       12,911,000  

Operating expenses:

        

Cost of product revenue

     902,000       888,000       3,615,000       3,551,000  

Research and development

     1,452,000       1,413,000       5,924,000       5,163,000  

Selling, general and administrative

     1,696,000       1,598,000       6,360,000       5,417,000  
                                

Total operating expenses

     4,050,000       3,899,000       15,899,000       14,131,000  

Loss from operations

     (351,000 )     (1,014,000 )     (1,825,000 )     (1,220,000 )
                                

Interest expense

     (3,000 )     (3,000 )     (11,000 )     (3,000 )

Investment income

     247,000       197,000       947,000       750,000  

Other income

     —         —         —         1,170,000  
                                

Net income (loss)

   $ (107,000 )   $ (820,000 )   $ (889,000 )   $ 697,000  
                                

Earnings Per Share:

        

Basic and diluted

   $ —       $ (0.03 )   $ (0.03 )   $ 0.02  
                                

Weighted average shares outstanding:

        

Basic

     30,420,000       30,202,000       30,379,000       30,125,000  
                                

Diluted

     30,420,000       30,202,000       30,379,000       30,691,000  
                                

 

    

As of March 31,

(In thousands)

 
     2007     2006  

Balance Sheet Data:

    

Cash and marketable securities*

   $ 22,627     $ 23,408  

Working capital

     22,394       18,575  

Total assets

     29,076       28,599  

Long-term obligations

     200       231  

Accumulated deficit

     (157,683 )     (156,794 )

Stockholders’ equity

     25,538       25,433  

* does not include restricted cash

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical statements, including, without limitation, statements regarding current or future financial performance and position, management’s strategy, plans and objectives for future operations, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, litigation, intellectual property, product development, manufacturing plans and performance such as the anticipated growth in the monoclonal antibody market and our other target markets and projected growth in product sales, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including, without limitation, risks associated with: the success of current and future collaborative relationships, the market acceptance of our products, our ability to compete with larger, better financed pharmaceutical and biotechnology companies, new approaches to the treatment of our targeted diseases, our expectation of incurring continued losses, our uncertainty of product revenues and profits, our ability to generate future revenues, our ability to raise additional capital to continue our drug development programs, the success of our clinical trials, our ability to develop and commercialize products, our ability to obtain required regulatory approvals, our compliance with all Food and Drug Administration regulations, our ability to obtain, maintain and protect intellectual property rights for our products, the risk of litigation regarding our intellectual property rights, our limited sales and manufacturing capabilities, our dependence on third-party manufacturers and value added resellers, our ability to hire and retain skilled personnel, our volatile stock price, and other risks detailed in Repligen’s filings with the Securities and Exchange Commission. Repligen assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.

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