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IDIX Reports 1Q08 Results

[This PR has no new info other than the financials. IDIX had $99M of cash as of 3/31/08. Guidance for 2008 cash burn is unchanged ($62M for the year and $49M during the remaining three quarters), leaving $50M at year-end. Please see actual PR for financial tables.]

http://biz.yahoo.com/prnews/080429/netu022.html?.v=49

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Tuesday April 29, 8:00 am ET

CAMBRIDGE, Mass., April 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 first quarter ended March 31, 2008. At March 31, 2008, Idenix's cash, cash equivalents and marketable securities totaled approximately $99.0 million.

2008 Year-to-Date Business Highlights

-- Idenix 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. In the first dosing cohort of this study, eight HIV-1 infected treatment-naive patients receiving 800 mg of IDX899 once-daily achieved a median reduction in plasma virus levels of approximately 2.0 log10, or 99 percent, after seven days of treatment. The 400 mg cohort of this study is now complete and dosing has been initiated in the 200 mg cohort. To date, no serious adverse events have been reported and no patients have discontinued from the study. Data from this clinical trial have been submitted for presentation at scientific meetings this summer.

-- The company continued to make progress with its hepatitis C discovery and development programs, having presented data from preclinical studies of its lead nucleotide prodrug candidate, IDX184, and potential clinical candidates from its protease inhibitor program at the annual meeting of the European Association for the Study of the Liver (EASL) last week. (Please see Idenix press release dated April 23, 2008 for more information regarding the EASL presentations.)

-- The lead clinical candidate from the nucleotide prodrug program, IDX184, is on track for an investigational new drug (IND) application submission in the first half of 2008. Based on the preclinical pharmacology and toxicology profile of IDX184 demonstrated to date, the company anticipates that the first-in- man clinical trial should be initiated in the second half of 2008.

-- Idenix also reported positive preclinical data from its HCV protease inhibitor program, with internally discovered compounds exhibiting potency in the HCV replicon system and good pharmacokinetic profiles in several animal species.

"We have made significant progress in the last six months in the discovery and development of our HCV and HIV programs," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "We are very pleased with the initial antiviral activity and safety data generated in the IDX899 clinical development program. Based on the profile of IDX899 exhibited to date, we believe that IDX899 could play an important role in the treatment of patients with HIV."

Sommadossi continued, "Our expertise and focus on antiviral discovery and development enables us to rapidly advance our programs through IND-enabling preclinical studies, proof-of-concept testing and into phase II clinical studies. With a comprehensive HCV discovery program in each of the major classes of direct-acting HCV antivirals, we are uniquely positioned to be one of the first companies to develop our own specifically targeted antiviral therapy for HCV (STAT-C)."

For the first quarter ended March 31, 2008, Idenix reported total revenues of $2.0 million, compared with total revenues of $24.8 million in the first quarter of 2007. The reduction in total revenues for the first quarter of 2008 as compared to the first quarter of 2007 was due to a decline of approximately $12.0 million in reimbursements of research and development costs from Novartis and the lack of receipt of milestone payments during the first quarter of 2008. Total revenues for the first quarter of 2008 consisted primarily of the amortization of upfront fees associated with development programs licensed by Novartis and royalties associated with worldwide sales of Tyzeka®/Sebivo® (telbivudine). Idenix reported a net loss of $20.5 million, or a loss of $0.36 per basic and diluted share, for the first quarter ended March 31, 2008, compared to a net loss of $11.6 million, or a loss of $0.21 per basic and diluted share, for the first quarter ended March 31, 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 today at 8:30 a.m. ET. To access the call please dial 800-471-3635 U.S./Canada 706-758-9475 International and enter conference identification number 43988689 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at www.idenix.com. Please log in approximately 10 minutes before the call to ensure a timely connection. An archived webcast will be available on the Idenix website for two weeks after the call. A replay of the call will also be available. To access the replay, please dial 800-642-1687 U.S./Canada or 706-645-9291 International and enter the passcode 43988689.
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