-----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, GfUk3x/HYGsivbQI9jC/7GQ7/ijxRUDYxz/pRquxQUsCCvG9UWHK63lgbRbvSKe3 b//udjOCrtRt/rjp5H6RSA== 0001035704-07-000727.txt : 20071030 0001035704-07-000727.hdr.sgml : 20071030 20071030161541 ACCESSION NUMBER: 0001035704-07-000727 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20071030 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071030 DATE AS OF CHANGE: 20071030 FILER: COMPANY DATA: COMPANY CONFORMED NAME: REPLIDYNE INC CENTRAL INDEX KEY: 0001180145 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 841568247 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-52082 FILM NUMBER: 071199779 BUSINESS ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 BUSINESS PHONE: 303-665-3450 MAIL ADDRESS: STREET 1: 1450 INFINITE DRIVE CITY: LOUISVILLE STATE: CO ZIP: 80027 8-K 1 d50913e8vk.htm FORM 8-K e8vk
 

 
 
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 October 30, 2007
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction of
incorporation or organization)
  000-52082
(Commission File Number)
  84-1568247
(I.R.S. Employer
Identification No.)
         
1450 Infinite Drive,
Louisville, Colorado

(Address of principal executive offices)
      80027
(Zip Code)
303-996-5500
(Registrant’s telephone number, including area code)
Not Applicable
(Former name, former address and former fiscal year, if changed since last report)
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:
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


 

INFORMATION TO BE INCLUDED IN THE REPORT
Item 2.02 Results of Operations and Financial Condition.
     On October 30, 2007, Replidyne, Inc. issued a press release reporting its results of operations for the third quarter of fiscal 2007 ending September 30, 2007. A copy of the press release is attached as Exhibit 99.1 to this current report on Form 8-K and incorporated by reference herein.
     The information in this item (including Exhibit 99.1) is being furnished pursuant to Item 2.02 and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
     
99.1
  Press Release dated October 30, 2007 reporting its results of operations for the third quarter of fiscal 2007.

 


 

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.
         
  REPLIDYNE, INC.
 
 
Dated: October 30, 2007  By:   /s/ Mark L. Smith    
    Mark L. Smith   
    Chief Financial Officer
Principal Accounting Officer 
 
 

 


 

EXHIBIT INDEX
     
Exhibit No.   Description
 
   
99.1
  Press Release dated October 30, 2007 reporting its results of operations for the third quarter of fiscal 2007.

 

EX-99.1 2 d50913exv99w1.htm PRESS RELEASE exv99w1
 

EXHIBIT 99.1
(Replidyne LOGO)
Replidyne contact:
Sabrina B. Oei
Dir. Investor & Public Relations
T: (303) 996-5535
Replidyne Announces Third Quarter 2007 Earnings
Louisville, CO, October 30, 2007 — Replidyne, Inc. (Nasdaq: RDYN) today announced its financial results for the third quarter and nine months ended September 30, 2007.
Replidyne reported a net loss of $12.3 million for the third quarter ended September 30, 2007 compared to a net loss of $5.7 million for the quarter ended September 30, 2006. For the nine months ended September 30, 2007, Replidyne reported net income of $24.6 million compared to a net loss of $19.6 million for the nine months ended September 30, 2006. Cash, cash equivalents and short-term investments on hand at September 30, 2007 totaled $101.7 million.
“Replidyne continues to pursue clear objectives in our clinical and preclinical programs,” said Kenneth J. Collins, Replidyne’s President and CEO. “We are moving forward with partnering discussions while completing preparations for the initiation of Phase III clinical trials in community-acquired pneumonia and acute bacterial sinusitis. We are also building and strengthening our research pipeline. We recently disclosed REP3123 as the lead product candidate in our C. difficile program, and anticipate filing an investigational new drug application in the second half of 2008. We are fortunate to be in a strong financial position to execute these objectives.”
Due to the conclusion of the collaboration agreement with Forest Laboratories (Forest) effective May 7, 2007, there was no revenue reported for the third quarter of 2007. Revenue for the nine months ended September 30, 2007 was $58.6 million. Upon termination of the agreement with Forest, all unamortized upfront and milestone payments as well as contract revenue for funded activities were fully recognized as revenue on May 7, 2007. Replidyne will not report any revenue under this agreement in future reporting periods.
Research and development expenses in the third quarter of 2007 were $10.7 million compared to $7.2 million in the corresponding quarter of 2006. Faropenem related expense represented approximately 64% of total research and development expense this quarter, primarily for costs to prepare for patient enrolment in three planned Phase III clinical trials of faropenem; one for treatment of acute bacterial

 


 

sinusitis and two for treatment of community acquired pneumonia. These preparations position the faropenem program to commence patient enrolment in clinical trials this Northern Hemisphere respiratory infections season. Costs were also incurred for the faropenem program to support the ongoing Phase III clinical trial of faropenem for treatment of acute exacerbations of chronic bronchitis. Additionally, research and development expense also included costs for preclinical activities targeted to Replidyne’s discovery research programs, primarily C. difficile and inhibition of DNA replication, and to prepare for future clinical trials of REP8839, including an upcoming Phase II clinical trial among pediatric patients with impetigo.
Sales, general and administrative expenses for the third quarter of 2007 were $3.0 million compared to $3.9 million in the third quarter of 2006 reflecting lower compensation related and marketing study expenses in the 2007 quarter. Replidyne reported a net loss attributable to common stockholders for the third quarter of 2007 of $12.3 million or, $0.46 per basic and diluted common share. This result compared to a net loss attributable to common stockholders of $5.8 million, or a net loss of $0.23 per basic and diluted common share in the third quarter of 2006.
Conference Call Information
Replidyne will host a conference call and webcast today, October 30, 2007, at 4:45 P.M. EDT to discuss third quarter 2007 financial results and recent corporate developments. Callers may participate in the conference call by dialing 800-435-1261 (domestic) or 617-614-4076 (international), and providing the passcode 57078639. To access the live webcast, log on to the Company’s website at www.Replidyne.com and go to the Investor Relations section.
A replay of the conference call will be available approximately one hour after the completion of the call through Tuesday, November 13, 2007 at midnight. Callers may access the replay by dialing 888-286-8010 (U.S. participants) or 617-801-6888 (international participants). The audio replay passcode is 69926595. To access a replay of the webcast, visit the Investor Relations section of the Company’s website at www.Replidyne.com.
About Replidyne, Inc.
Replidyne is a biopharmaceutical company focused on discovering, developing, in-licensing and commercializing innovative anti-infective products. Replidyne’s lead product, faropenem medoxomil, is a novel oral community antibiotic, expected to be appropriate for use as a first-line antibiotic for treatment of respiratory and skin infections in adult and pediatric patients. Replidyne’s second drug candidate, REP8839, is a topical anti-infective product candidate in development for the treatment of skin and wound infections, including methicillin-resistant S. aureus (MRSA) infections. Replidyne’s investigational antibacterial agent REP3123 targets Gram-positive C. difficile bacteria and C. difficile-associated disease (CDAD). Replidyne is pursuing the development of other novel anti-infective programs based on its in-house discovery research.

 


 

Safe Harbor
This press release contains plans, intentions, objectives, estimates and expectations that constitute forward-looking statements about Replidyne, Inc. that involve significant risks and uncertainties. Actual results could differ materially from those discussed due to a number of factors including, the success and timing of pre-clinical studies and clinical trials; the Company’s ability to obtain a new partner for faropenem on acceptable terms; the Company’s ability to obtain and maintain regulatory approval of product candidates and the labeling under any approval that may be obtained; plans to develop and commercialize product candidates; the loss of key scientific or management personnel; the size and growth of the potential markets for the Company’s product candidates and the Company’s ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of Company estimates regarding expenses, future revenues and capital requirements; the Company’s ability to obtain and maintain intellectual property protection for our product candidates; the successful development of the Company’s sales and marketing capabilities; the success of competing drugs that are or become available; and the performance of third party manufacturers. These and additional risks and uncertainties are described more fully in the Company’s most recent Form 10-Q filed with the SEC under the Securities Exchange Act of 1934. Copies of filings made with the SEC are available through the SEC’s electronic data gather analysis and retrieval system (EDGAR) at www.sec.gov. All forward-looking statements made in the press release are made as of the date hereof and the Company assumes no obligation to update the forward-looking statements in the document.

 


 

REPLIDYNE, INC.
CONDENSED BALANCE SHEETS
(in thousands)
(unaudited)
                 
    September 30,     December 31,  
    2007     2006  
ASSETS
 
               
Current assets:
               
Cash and cash equivalents
  $ 39,875     $ 24,091  
Short-term investments
    61,856       101,476  
Receivable from Forest Laboratories
          4,634  
Prepaid expenses and other current assets
    2,921       2,079  
 
           
Total current assets
    104,652       132,280  
 
               
Property and equipment, net
    2,131       3,170  
Other assets
    113       111  
 
           
Total assets
  $ 106,896     $ 135,561  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
 
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 8,313     $ 7,957  
Current portion of deferred revenue
          56,176  
 
           
Total current liabilities
    8,313       64,133  
 
               
Other long-term liabilities
    37       56  
 
           
Total liabilities
    8,350       64,189  
 
           
 
               
Commitments and contingencies
               
 
               
Stockholders’ equity
    98,546       71,372  
 
           
Total liabilities and stockholders’ equity
  $ 106,896     $ 135,561  
 
           

 


 

REPLIDYNE, INC.
CONDENSED STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
(unaudited)
                                 
    Three Months Ended September 30,     Nine Months Ended September 30,  
    2007     2006     2007     2006  
Revenue
  $     $ 3,679     $ 58,571     $ 10,601  
 
                       
 
                               
Costs and expenses:
                               
 
                               
Research and development
    10,651       7,177       28,462       25,287  
Sales, general and administrative
    2,988       3,864       9,803       8,676  
 
                       
Total costs and expenses
    13,639       11,041       38,265       33,963  
 
                       
 
                               
(Loss) income from operations
    (13,639 )     (7,362 )     20,306       (23,362 )
 
                               
Investment income and other, net
    1,336       1,640       4,329       3,730  
 
                       
Net (loss) income
    (12,303 )     (5,722 )     24,635       (19,632 )
 
                               
Preferred stock dividends and accretion.
          (85 )           (5,391 )
 
                       
 
                               
Net (loss) income attributable to common stockholders
  $ (12,303 )   $ (5,807 )   $ 24,635     $ (25,023 )
 
                       
 
                               
Net (loss) income attributable to common stockholders per share — basic
  $ (0.46 )   $ (0.23 )   $ 0.92     $ (2.59 )
 
                       
 
                               
Net (loss) income attributable to common stockholders per share — diluted.
  $ (0.46 )   $ (0.23 )   $ 0.89     $ (2.59 )
 
                       
 
                               
Weighted average common shares outstanding — basic
    26,780       25,748       26,696       9,659  
 
                       
 
                               
Weighted average common shares outstanding — diluted
    26,780       25,748       27,666       9,659  
 
                       
- ENDS -

 

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