Biotech Values

[DewDiligence]

IDIX Reports 4Q09 Results

[No news in this PR because IDIX pre-announced its 4Q09 cash balance of $48.1M at the JPM conference in January (#msg-45350536). The table in #msg-45351175 lays out IDIX’s liquidity and cash usage.]

http://finance.yahoo.com/news/Idenix-Pharmaceuticals-prnews-3771334699.html?x=0&.v=1

›Thursday February 25, 2010, 4:05 pm

CAMBRIDGE, Mass., Feb. 25 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today reported unaudited financial results for the fourth quarter and year ended December 31, 2009. At December 31, 2009, Idenix's cash, cash equivalents and marketable securities totaled $48.1 million.

Business Highlights

• In the fourth quarter of 2009, Idenix initiated a 14-day dose-ranging phase IIa study evaluating IDX184, a once-daily liver-targeted HCV nucleotide prodrug, in combination with pegylated interferon and ribavirin (PegIFN/RBV) in treatment-naïve HCV genotype 1 infected patients. All patients in the 50 mg cohort, the lowest dose in this study, have completed treatment. The mean viral load reduction +/- standard deviation at 14 days for the 50 mg cohort receiving IDX184 in combination with PegIFN/RBV (n=16) was -2.7 +/- 1.3 log10 IU/ml compared to -1.9 +/- 1.1 log10 IU/ml for the group receiving placebo plus PegIFN/RBV (n=4). Two IDX184-treated patients achieved undetectable virus levels (< 15 IU/mL) at Day 14 as well as a third IDX184-treated patient by Day 21 compared to none in the placebo plus PegIFN/RBV group. The safety profile of IDX184 combined with PegIFN/RBV remains consistent with the laboratory and side effect profile of PegIFN/RBV. The study is progressing with enrollment of the 100 mg cohort.

• In January 2010, the company announced data from the first five cohorts (25 mg QD, 50 mg QD, 100 mg QD, 200 mg QD and 200 mg BID) in an ongoing double-blind, placebo-controlled phase I study for IDX375, an HCV non-nucleoside polymerase inhibitor. Data suggest a favorable pharmacokinetic and safety profile in healthy volunteers. This clinical trial was conducted under a European clinical trial application (CTA) using the choline salt form of IDX375. In the first quarter of 2010, Idenix submitted a CTA for a free acid form of IDX375. The active pharmaceutical ingredient as a free acid allows improved manufacturing processes and long-term stability of the drug product, providing diverse formulation options. Idenix plans to continue the phase I program with higher single and multiple doses of the free acid form of IDX375 in healthy volunteers.

• In December 2009, Idenix submitted a CTA for IDX320, an HCV protease inhibitor exhibiting nanomolar potency, broad genotypic coverage and favorable pharmacokinetics in preclinical studies. A double-blind, placebo-controlled phase I clinical trial evaluating single and multiple ascending doses of IDX320 in healthy volunteers is ongoing.

• In 2009, GSK2248761/IDX899, a non-nucleoside reverse transcriptase inhibitor for the treatment of HIV-1, progressed through long-term chronic toxicology studies and drug-drug interaction studies in healthy volunteers with a favorable safety and drug-drug interaction profile. A broad phase IIb clinical development program is anticipated to begin in 2010.

"We are pleased with the progress our partner, GlaxoSmithKline, has achieved with GSK2248761 and with our accomplishment of advancing three clinical candidates from major HCV drug classes to human testing. We look forward to GSK's initiation of phase IIb studies with GSK2248761 and multiple data readouts from our HCV programs throughout the year," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "In 2010, as the profiles of our HCV drug candidates continue to emerge, we will seek to build a combination drug development strategy, both internally and with partners, to advance the future HCV treatment paradigm."

Fourth Quarter and Full Year 2009 Financial Results

For the fourth quarter ended December 31, 2009, Idenix reported total revenues of $3.0 million, compared to total revenues of $4.3 million in the fourth quarter of 2008. The company reported a net loss of $12.3 million, or a loss of $0.19 per basic and diluted share, for the fourth quarter ended December 31, 2009, compared to a net loss of $13.9 million, or a loss of $0.25 per basic and diluted share for the fourth quarter ended December 31, 2008.

For the twelve months ended December 31, 2009, Idenix reported total revenues of $12.6 million, compared to total revenues of $10.0 million for the twelve months ended December 31, 2008. The majority of the increase was due to additional license fee revenue and royalty revenue recognized, related to our collaborations with GlaxoSmithKline and Novartis Pharma AG, as compared to the same period in 2008. The company reported a net loss of $53.2 million, or a loss of $0.87 per basic and diluted share for the twelve months ended December 31, 2009, compared to $70.2 million, or a loss of $1.24 per basic and diluted share for the twelve months ended December 31, 2008. The change in net loss was primarily a result of lower operating expenses in 2009 as compared to 2008.

2010 Financial Guidance

The company expects that its current cash, cash equivalents and marketable securities can fund operations through at least the next twelve months. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.

Conference Call and Webcast Information

Idenix will hold a conference call today at 4:30 p.m. ET. To access the call please dial [phone] U.S./Canada or [phone] International and enter passcode 54113451. 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. A replay of the conference call and webcast will be available until March 11, 2010. To access the replay, please dial [phone] U.S./Canada or [phone] International and enter the passcode 54113451.

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 diseases. Idenix's current focus is on the treatment of infections caused by the hepatitis C virus. For further information about Idenix, please refer to www.idenix.com.‹