CAMBRIDGE, Mass., July 29 /PRNewswire-FirstCall/ -- 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 log(10) 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 log(10) 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 http://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.
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 http://www.idenix.com.
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
Idenix Pharmaceuticals' Contact:
Amy Sullivan (617) 995-9838
IDENIX PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(IN THOUSANDS, EXCEPT PER SHARE DATA)
Three Months Ended Six Months Ended
June 30, June 30,
2008 2007 2008 2007
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
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 ------
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
June 30, December 31,
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
|SOURCE Idenix Pharmaceuticals, Inc.|
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