CAMBRIDGE, Mass., Feb. 23, 2012 /PRNewswire/ -- 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, 2011 as well as the advancement of its hepatitis C virus (HCV) development pipeline.
Operational Highlights
IDX184 Program
The Company’s lead program, IDX184, is a pan-genotypic oral nucleotide polymerase inhibitor for the treatment of HCV. In July 2011, Idenix initiated enrollment of treatment-naive HCV-infected patients into a 12-week phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin. In January 2012, the Company reported an interim analysis from this study of the first 31 patients who completed 28 days of treatment demonstrating favorable safety and antiviral activity. At 12 weeks, the Complete Early Virologic Response (cEVR < 25 IU/mL) was 93% for the 100 mg IDX184 arm (n=15) and 81% for the 50 mg IDX184 arm (n=16) of the study (intent-to-treat analysis). The side effect profile of the combined therapy has remained consistent with the known safety profile for pegylated interferon and ribavirin.
In February 2012, the U.S. Food and Drug Administration removed the partial clinical hold on IDX184 after review of the interim phase IIb data and the independent Data Safety Monitoring Board’s recommendation to continue the study. The Company has now begun enrollment of an additional 30 patients under expanded enrollment criteria in the ongoing phase IIb clinical trial. Additionally, the Company anticipates implementing a broad phase IIb program with IDX184, focusing on the evaluation of interferon-free direct-acting antiviral (DAA) combination regimens, in the coming months.
IDX719 Program
In January 2012, the Company initiated a phase I clinical study of IDX719, its NS5A inhibitor candidate. The first part of the study is evaluating the safety, pharmacokinetics and food effect of IDX719 in 48 healthy volunteers at single doses ranging from 5 to 100 mg. Dosing up to 50 mg has been completed in healthy volunteers and to date IDX719 has been well tolerated. A cohort of eight HCV genotype 1-infected patients received single doses of IDX719 of either 1, 5, 10 or 25 mg (2 patients per dose). Mean maximal viral load reductions were 1.9 log(10), 2.6 log(10), 3.3 log(10) and 3.7 log(10), respectively. A 3-day proof-of-concept segment of the study in treatment-naive genotype 1 HCV-infected patients is expected to begin in the second quarter of 2012 with additional cohorts of genotype 2, 3, or 4 HCV-infected patients to be added during the study.
Nucleotide Discovery Program
In January 2012, Idenix selected two nucleotide inhibitors, IDX19368 and IDX19370, as potential clinical candidates from its novel nucleotide prodrug discovery program. IDX19368 has demonstrated strong potency in preclinical studies and as a result the Company has chosen IDX19368 as its lead candidate and expects to submit an investigational new drug application (IND) for IDX19368 in mid-2012. The Company continues to identify new promising compounds and evaluate multiple candidates for further development from this discovery program.
“Our focus for 2012 will be to build on the progress we made last year through the continued advancement of our pipeline of novel HCV drug candidates,” said Ron Renaud, Idenix’s President and Chief Executive Officer. “Now that the partial clinical hold has been removed for IDX184, we will be able to explore the full potential of this promising nucleotide polymerase inhibitor in combination with other DAAs in a broad phase IIb program. The early results are promising for IDX719, our NS5A inhibitor, in HCV patients and we look forward to completing the phase I clinical trial, as well as initiating a phase I study for our next-generation nucleotide inhibitor, IDX19368. We believe that the potent and pan-genotypic profiles of our drug candidates support their potential role in future HCV combination regimens.”
Fourth Quarter and Year End 2011 Financial Results
For the fourth quarter ended December 31, 2011, Idenix reported total revenues of ($0.7) million, compared to total revenues of $2.4 million in the fourth quarter of 2010. In the fourth quarter of 2011, the Company recorded a charge against revenue related to the impact of the stock subscription rights of Novartis Pharma AG (Novartis), which is described in more detail below. The Company reported a net loss of $18.1 million, or a loss of $0.18 per basic and diluted share, for the fourth quarter ended December 31, 2011, compared to a net loss of $16.2 million, or a loss of $0.22 per basic and diluted share for the fourth quarter ended December 31, 2010.
Under the stock purchase agreement that Idenix entered into with Novartis in 2003, Novartis has the right to maintain its percentage ownership in Idenix by purchasing shares of Idenix’s common stock when stock options are exercised under certain stock plans. As of December 31, 2011, the fair market value of Idenix’s common stock that would be issuable to Novartis under this stock subscription right, less the exercise price that would be paid by Novartis impacted the consolidated statements of operations as a reduction of the revenue associated with the Novartis collaboration. For the fourth quarter ended December 31, 2011, the Company recorded $2.0 million of revenue related to the Novartis collaboration and a charge against revenue of $3.4 million due to this stock subscription right resulting in net contra-revenue related to Novartis of $1.4 million as shown in the consolidated statements of operations.
For the year ended December 31, 2011, Idenix reported total revenues of $7.0 million, compared to total revenues of $10.2 million in the year ended December 31, 2010. The Company reported a net loss of $52.0 million, or a loss of $0.57 per basic and diluted share, for the year ended December 31, 2011, compared to a net loss of $61.6 million, or a loss of $0.87 per basic and diluted share for the year ended December 31, 2010. The $9.6 million reduction in net loss in 2011 was due primarily to $7.2 million of non-recurring severance and restructuring expenses in 2010.
2012 Financial Guidance
At December 31, 2011, Idenix’s cash and cash equivalents totaled $118.3 million. The Company expects that its current cash, cash equivalents and the anticipated royalty payments associated with product sales of Tyzeka®/Sebivo® (telbivudine) will be sufficient to sustain its operations through at least the next twelve months from December 31, 2011. This guidance assumes no milestone payments, license fees, reimbursement for development programs and no financing activities.
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 patients with hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
