-----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, W1K2HewUqAsYiU3okarZpik1A9i8zZK8Vi1pHMNbgwInjzqOekrjrAiIbt2NML4L l7myJypZNwtPA2I9FiXI3w== 0000950135-08-005177.txt : 20080729 0000950135-08-005177.hdr.sgml : 20080729 20080729072310 ACCESSION NUMBER: 0000950135-08-005177 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20080729 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080729 DATE AS OF CHANGE: 20080729 FILER: COMPANY DATA: COMPANY CONFORMED NAME: IDENIX PHARMACEUTICALS INC CENTRAL INDEX KEY: 0001093649 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 450478605 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-49839 FILM NUMBER: 08974196 BUSINESS ADDRESS: STREET 1: 60 HAMPSHIRE STREET STREET 2: . CITY: CAMBRIDGE STATE: MA ZIP: 02139 BUSINESS PHONE: (617) 250-3100 MAIL ADDRESS: STREET 1: 60 HAMPSHIRE STREET CITY: CAMBRIDGE STATE: MA ZIP: 02139 FORMER COMPANY: FORMER CONFORMED NAME: NOVIRIO PHARMACEUTICALS LTD DATE OF NAME CHANGE: 19990820 8-K 1 b71426ipe8vk.htm IDENIX PHARMACEUTICALS, INC. e8vk
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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): July 29, 2008
Idenix Pharmaceuticals, Inc.
 
(Exact Name of Registrant as Specified in Charter)
         
Delaware   000-49839   45-0478605
 
(State or Other Juris-
diction of Incorporation
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
60 Hampshire Street
Cambridge, MA
  02139
 
(Address of Principal Executive Offices)   (Zip Code)
Registrant’s telephone number, including area code: 617-995-9800
 
(Former Name or Former Address, 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 (see General Instruction A.2. below):
          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))
 
 

 


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Item 2.02. Results of Operations and Financial Condition
Item 9.01. Financial Statements and Exhibits
SIGNATURE
EXHIBIT INDEX
Ex-99.1 Press Release dated July 29, 2008


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Item 2.02. Results of Operations and Financial Condition
          On July 29, 2008, Idenix Pharmaceuticals, Inc. announced its financial results for the quarter ended June 30, 2008. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.
          The information in this Form 8-K (including Exhibit 99.1) 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
 
   
 
  The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed:
 
   
 
  99.1      Press Release dated July 29, 2008.

 


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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.
         
  Idenix Pharmaceuticals, Inc.
 
 
Date: July 29, 2008  By:   /s/ Ronald C. Renaud, Jr.    
    Ronald C. Renaud, Jr.   
    Chief Financial Officer   
 

 


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EXHIBIT INDEX
     
Exhibit No.
  Description
 
   
99.1
  Press release dated July 29, 2008

 

EX-99.1 2 b71426ipexv99w1.htm EX-99.1 PRESS RELEASE DATED JULY 29, 2008 exv99w1
Exhibit 99.1
[IDENIX LETTERHEAD]
Idenix Pharmaceuticals’ Contact:
Amy Sullivan (617) 995-9838
IDENIX PHARMACEUTICALS REPORTS SECOND QUARTER AND SIX MONTH FINANCIAL RESULTS
Cambridge, MA, July 29, 2008 — Idenix Pharmaceuticals, Inc. (NASDAQ: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the second quarter ended June 30, 2008. At June 30, 2008, Idenix’s cash, cash equivalents and marketable securities totaled $80.6 million.
2008 Year-to-Date Business Highlights
    Idenix has reported positive data from an ongoing phase I/II study of IDX899, a non-nucleoside reverse transcriptase inhibitor (NNRTI) being developed for the treatment of HIV-1. Patients receiving once-daily IDX899 achieved a mean plasma viral load reduction of approximately 1.8 log10 after seven days of treatment in each of the 800 mg, 400 mg and 200 mg dosing cohorts. Patients receiving placebo had a 0.05 log10 viral load increase over the same treatment period. No treatment-related serious adverse events were reported for any of the patients receiving IDX899 and no patients discontinued the study. Based on the potent antiviral activity of IDX899 observed to date, the study was recently amended to also evaluate a 100 mg/day dose.
 
    Idenix has submitted an investigational new drug (IND) application for IDX184, a once-daily, oral nucleotide prodrug candidate for the treatment of chronic hepatitis C, to the United States Food and Drug Administration (FDA) and has initiated a phase I single dose escalation study in healthy volunteers. IDX184 has demonstrated HCV antiviral activity in both in vitro and in vivo preclinical models.
 
    Idenix has continued to make progress in its preclinical HCV discovery effort. Clinical candidates from both its HCV protease inhibitor and non-nucleoside polymerase inhibitor programs are entering IND-enabling preclinical studies.
“This year, we have continued to advance our HCV and HIV discovery and development programs,” said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. “We now have a pipeline that includes a promising HIV drug candidate and HCV drug candidates from each of the major HCV drug classes, nucleoside/tide polymerase inhibitors, non-nucleoside polymerase inhibitors and protease inhibitors.”
For the second quarter ended June 30, 2008, Idenix reported total revenues of $1.6 million, compared with total revenues of $19.7 million in the second quarter of 2007. The decrease is primarily due to a decline of $11.5 million in reimbursements of research and development costs from Novartis and a decrease of $6.7 million in license fee revenue. Idenix reported a net loss of $18.9 million, or a loss of $0.34 per basic and diluted share, for the second quarter ended June 30, 2008, compared to a net loss of $22.9 million, or a loss of $0.41 per basic and diluted share, for the second quarter ended June 30, 2007.
For the six months ended June 30, 2008, Idenix reported total revenues of $3.6 million, compared with total revenues of $44.5 million for the six months ended June 30, 2007. The decrease was due to a decline of $23.0 million in reimbursements of research and development costs from Novartis, a decrease of $8.2 million in license fee revenue and the lack of milestone payments during the first half of 2008 as compared to the first half of 2007. The company reported a net loss of $39.4 million, or a loss of $0.70

 


 

per basic and diluted share, for the six months ended June 30, 2008, compared with a net loss of $34.5 million, or a loss of $0.61 per basic and diluted share, for the six months ended June 30, 2007.
2008 Financial Guidance
The company continues to expect to end 2008 with approximately $50.0 million of cash, cash equivalents and marketable securities, assuming no milestone payments, license fees, reimbursement for development programs, and no financing activities during 2008.
Conference Call Information
Idenix will hold a conference call and webcast today at 8:30 a.m. ET. To access the call please dial 800-471-3635 U.S./Canada or 706-758-9475 International and enter passcode 56201724 or to listen to and view the live webcast of the call, go to “Calendar of Events” in the Idenix Investor Center at www.idenix.com. A replay of the call will also be available from 11:30 a.m. ET on July 29, 2008 until 11:59 p.m. ET on August 12, 2008. To access the replay, please dial 800-642-1687 U.S./Canada or 706-645-9291 International and enter passcode 56201724. An archived webcast will also be available for two weeks after the call on the Idenix website.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral and other infectious diseases. Idenix’s current focus is on the treatment of infections caused by hepatitis C virus and HIV. For further information about Idenix, please refer to www.idenix.com.
Forward-looking Statements
This press release contains “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements can be identified by the use of forward-looking terminology such as “expect,” “plans,” “anticipates,” “will,” or similar expressions, or by express or implied statements with respect to the company’s clinical development programs or commercialization activities in HIV or hepatitis C, or any potential pipeline candidates and expectations with respect to additional milestone payments, future royalty payments and cash balances at the end of 2008. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. There can be no guarantees that historical sales of Tyzeka/Sebivo will in any way suggest future royalty payments or royalty rates owed to the company, or that the company will advance any clinical product candidate or other component of its potential pipeline to the clinic, to the regulatory process or to commercialization. In particular, management’s expectations could be affected by unexpected regulatory actions or delays; uncertainties relating to, or unsuccessful results of, clinical trials, including additional data relating to the ongoing clinical trials evaluating its product candidates; the company’s ability to obtain additional funding required to conduct its research, development and commercialization activities; the company’s dependence on its collaboration with Novartis Pharma AG; changes in the company’s business plan or objectives; the ability of the company to attract and retain qualified personnel; competition in general; and the company’s ability to obtain, maintain and enforce patent and other intellectual property protection for its product candidates and its discoveries. These and other risks which may impact management’s expectations are described in greater detail under the caption “Risk Factors” in the company’s quarterly report on Form 10-Q for the quarter ended March 31, 2008 as filed with the Securities and Exchange Commission (SEC) and other filings that the company makes with the SEC.
All forward-looking statements reflect the company’s expectations only as of the date of this release and should not be relied upon as reflecting the company’s views, expectations or beliefs at any date subsequent to the date of this release. Idenix anticipates that subsequent events and developments may cause these views, expectations and beliefs to change. However, while Idenix may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so.

 


 

IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
(UNAUDITED)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2008     2007     2008     2007  
 
                               
Revenues:
                               
Collaboration revenue — related party
  $ 1,433     $ 18,674     $ 3,478     $ 43,025  
Other revenue
     159       1,058        157       1,513  
 
                       
Total revenues
    1,592       19,732       3,635       44,538  
 
                               
Operating expenses (1):
                               
Cost of sales
    415       167       810       237  
Research and development
    14,136       24,570       29,004       47,124  
Selling, general and administrative
    6,651       19,837       14,972       35,677  
Restructuring charges
    37              297        
 
                       
Total operating expenses
    21,239       44,574       45,083       83,038  
 
                       
Loss from operations
    (19,647 )     (24,842 )     (41,448 )     (38,500 )
Investment income and other income, net
    485       1,802       1,425       3,780  
 
                       
Loss before income taxes
    (19,162 )     (23,040 )     (40,023 )     (34,720 )
Income tax benefit
    256       138        657        249  
 
                       
Net loss
  $ (18,906 )   $ (22,902 )   $ (39,366 )   $ (34,471 )
 
                       
 
                               
Basic and diluted net loss per share:
    ($0.34 )     ($0.41 )     ($0.70 )     ($0.61 )
 
                       
 
                               
Shares used in calculation of basic and diluted net loss per share:
    56,359       56,170       56,316       56,148  
 
                       
 
                               
(1) Stock-based compensation expenses included in operating expenses amounted to approximately:  
 
                               
Research and development
  $ 467     $ 723     $ 1,127     $ 1,891  
 
                               
Selling, general and administrative
    876       1,296       1,755       2,533  

 


 

IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(IN THOUSANDS)
(UNAUDITED)
                 
    June 30,     December 31,  
    2008     2007  
 
               
ASSETS
               
Cash and cash equivalents
  $ 54,062     $ 48,260  
Marketable securities
    16,270       39,862  
Receivables from related party
    1,727       11,196  
Other current assets
    3,221       4,401  
 
           
Total current assets
    75,280       103,719  
Intangible asset, net
    12,968       13,548  
Property and equipment, net
    14,873       15,460  
Marketable securities, non-current
    10,308       23,882  
Other assets
    3,852       3,931  
 
           
Total assets
  $ 117,281     $ 160,540  
 
           
 
               
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Accounts payable and accrued expenses
  $ 15,953     $ 21,809  
Deferred revenue, related party
    7,766       8,372  
Other current liabilities
     645        553  
 
           
Total current liabilities
    24,364       30,734  
Long-term obligations
    18,237       19,107  
Deferred revenue, related party, net of current portion
    34,948       41,861  
 
           
Total liabilities
    77,549       91,702  
Stockholders’ equity
    39,732       68,838  
 
           
Total liabilities and stockholders’ equity.
  $ 117,281     $ 160,540  
 
           

 

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