-----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, APUJVTkJET7qFxjDa602WzOC6XUFOIaOtqNv4rN23d4dWHIrG9U3rvuk/HoLSckw AKTehZW48hey5AWPfVO1RA== 0001035704-07-000548.txt : 20070731 0001035704-07-000548.hdr.sgml : 20070731 20070731161045 ACCESSION NUMBER: 0001035704-07-000548 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20070731 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20070731 DATE AS OF CHANGE: 20070731 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: 071012871 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 d48554e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
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 July 31, 2007
REPLIDYNE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   000-52082   84-1568247
(State or other jurisdiction of   (Commission File Number)   (I.R.S. Employer
incorporation or organization)       Identification No.)
     
1450 Infinite Drive,    
Louisville, Colorado   80027
(Address of principal executive offices)   (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))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition
Item 9.01 Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
Press Release


Table of Contents

INFORMATION TO BE INCLUDED IN THE REPORT
Item 2.02 Results of Operations and Financial Condition.
     On July 31, 2007, Replidyne, Inc. issued a press release reporting its results of operations for the second quarter of fiscal 2007 ending June 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 July 31, 2007 reporting its results of operations for the second quarter of fiscal 2007.

 


Table of Contents

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: July 31, 2007  By:   /s/ Mark L. Smith    
    Mark L. Smith   
    Chief Financial Officer
Principal Accounting Officer 
 

 


Table of Contents

         
EXHIBIT INDEX
     
Exhibit   Description
99.1
  Press Release dated July 31, 2007 reporting its results of operations for the second quarter of fiscal 2007.

 

EX-99.1 2 d48554exv99w1.htm PRESS RELEASE exv99w1
 

EXHIBIT 99.1
(REPLIDYNE LOGO)
Replidyne contact:
Sabrina B. Oei
Dir. Investor & Public Relations
T: (303) 996-5535
Replidyne Announces Second Quarter 2007 Earnings
Louisville, CO, July 31, 2007 – Replidyne, Inc. (Nasdaq: RDYN) today announced its financial results for the second quarter and cumulative six months ended June 30, 2007.
Replidyne reported net income of $45.5 million for the second quarter ended June 30, 2007 compared to a net loss of $6.2 million for the quarter ended June 30, 2006. Net income for the second quarter of 2007 included license and contract revenue totaling $55.6 million recognized on May 7, 2007, the effective termination date of Replidyne’s collaboration and commercialization agreement with Forest Laboratories (Forest). For the six month period ended June 30, 2007, Replidyne reported net income of $36.9 million compared to a net loss of $13.9 million for the six month period ended June 30, 2006. Cash, cash equivalents and short-term investments on hand at June 30, 2007 totaled $112.1 million.
“This quarter we continued to focus on defining the approval path for faropenem,” said Kenneth J. Collins, Replidyne’s President and CEO. “We are now actively engaged in identifying a new collaboration and development partner for faropenem and, in anticipation of a partnership, we are conducting all preparations to allow us to commence further Phase III clinical trials in community-acquired pneumonia and acute bacterial sinusitis by the end of this year. In the second half of this year other milestones to expect from Replidyne include presenting highly-anticipated research on our C. difficile program at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in September and initiating Phase II clinical trials for REP8839.”
As noted above, revenue for the second quarter of 2007 was $55.6 million compared to $4.0 million for the second quarter of 2006. Since entering the agreement with Forest in February 2006, non-refundable upfront and milestone payments totaling $60 million were recognized as revenue on a straight-line basis over approximately 15 years in accordance with Replidyne’s revenue recognition policy. Upon termination, the balance of unamortized upfront and milestone payments of $55.2 million was fully recognized as revenue in the second quarter of 2007. In addition, the Company recognized $0.4 million in contract revenue for funded activity through May 7, 2007 under the agreement. Funded activities represent Forest’s majority share of certain direct costs incurred to develop faropenem during the

 


 

agreement term. Based on termination of this agreement, Replidyne will not report any revenue under the agreement in future reporting periods.
Research and development expenses in the second quarter of 2007 were $8.4 million compared to $9.1 million in the corresponding quarter of 2006 and were substantially faropenem-related. Faropenem related research and development expense this quarter included costs to replace the contract research organization conducting the acute exacerbation of chronic bronchitis study. The new contract research organization is expected to oversee all planned faropenem Phase III registration studies. Additionally, research and development expense included costs to prepare for REP8839 Phase II clinical trials and preclinical activities targeted to Replidyne’s discovery research programs, primarily C. difficile and inhibition of DNA replication. Research and development expense in the second quarter of 2006 included $1.5 million paid to GlaxoSmithKline as final payment for the acquisition of REP8839 and its related technology.
Sales, general and administrative expenses for the second quarter of 2007 were $3.3 million compared to $2.9 million in the second quarter of 2006. Replidyne reported net income attributable to common stockholders for the second quarter of 2007 of $45.5 million or, $1.71 per basic common share. On a diluted basis, earnings per share were $1.65 per common share for the second quarter of 2007. This result compared to a net loss attributable to common stockholders of $8.9 million, or a net loss of $5.79 per basic and diluted common share in the second quarter of 2006.
Conference Call Information
Replidyne will host a conference call and webcast today, July 31, 2007, at 4:45 P.M. ET to discuss 2007 second quarter financial results and recent corporate developments. Callers may participate in the conference call by dialing 888-680-0890 (U.S. participants) or 617-213-4857 (international participants) and providing the passcode 27796470. 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, August 14, 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 31540010. 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 is also pursuing the development of other novel anti-infective products 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, except for share and per share amounts)
(Unaudited)
                 
    June 30,     December 31,  
    2007     2006  
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 56,841     $ 24,091  
Short-term investments
    55,257       101,476  
Receivable from Forest Laboratories
          4,634  
Prepaid expenses and other current assets
    1,981       2,079  
 
           
Total current assets
    114,079       132,280  
Property and equipment, net
    2,503       3,170  
Other assets
    121       111  
 
           
Total assets
  $ 116,703     $ 135,561  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
 
               
Current liabilities:
               
Accounts payable and accrued expenses
  $ 6,643     $ 7,957  
Current portion of deferred revenue
          56,176  
 
           
Total current liabilities
    6,643       64,133  
Other long-term liabilities
    44       56  
 
           
Total liabilities
    6,687       64,189  
 
           
 
               
Commitments and contingencies
               
 
               
Total stockholders’ equity
    110,016       71,372  
 
           
Total liabilities and stockholders’ equity
  $ 116,703     $ 135,561  
 
           

 


 

REPLIDYNE, INC.
CONDENSED STATEMENTS OF OPERATIONS
(In thousands, except share and per share amounts)
(Unaudited)
                                 
    Three Months Ended June 30,     Six Months Ended June 30,  
    2007     2006     2007     2006  
Revenue
  $ 55,647     $ 4,045     $ 58,571     $ 6,922  
 
                       
 
                               
Costs and expenses:
                               
 
                               
Research and development
    8,364       9,141       17,811       18,110  
 
                               
Sales, general and administrative
    3,280       2,859       6,815       4,812  
 
                       
 
                               
Total costs and expenses
    11,644       12,000       24,626       22,922  
 
                       
 
                               
Income (loss) from operations
    44,003       (7,955 )     33,945       (16,000 )
 
                               
Investment income and other, net
    1,487       1,747       2,993       2,090  
 
                       
 
                               
Net income (loss)
    45,490       (6,208 )     36,938       (13,910 )
 
                               
Preferred stock dividends and accretion
          (2,654 )           (5,306 )
 
                       
 
                               
Net income (loss) attributable to common stockholders
  $ 45,490     $ (8,862 )   $ 36,938     $ (19,216 )
 
                       
 
                               
Net income (loss) attributable to common stockholders per share - basic
  $ 1.71     $ (5.79 )   $ 1.39     $ (12.98 )
 
                       
 
                               
Net income (loss) attributable to common stockholders per share - diluted
  $ 1.65     $ (5.79 )   $ 1.34     $ (12.98 )
 
                       
 
                               
Weighted average common shares outstanding - basic
    26,676,886       1,530,965       26,649,042       1,480,407  
 
                       
 
                               
Weighted average common shares outstanding - diluted
    27,650,814       1,530,965       27,611,733       1,480,407  
 
                       
- ENDS -

 

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