CAMBRIDGE, Mass., Nov. 2, 2011 /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 third quarter and nine months ended September 30, 2011. At September 30, 2011, Idenix’s cash and cash equivalents totaled $64.7 million.
Third Quarter and Nine Month 2011 Financial Results
For the third quarter ended September 30, 2011, Idenix reported total revenues of $2.6 million, compared to total revenues of $3.8 million in the third quarter of 2010. The Company reported a net loss of $11.7 million, or a loss of $0.12 per basic and diluted share, for the third quarter ended September 30, 2011, compared to a net loss of $12.9 million, or a loss of $0.18 per basic and diluted share for the third quarter ended September 30, 2010.
For the nine months ended September 30, 2011, Idenix reported total revenues of $7.7 million, compared to total revenues of $7.8 million in the nine months ended September 30, 2010. The Company reported a net loss of $33.9 million, or a loss of $0.39 per basic and diluted share, for the nine months ended September 30, 2011, compared to a net loss of $45.4 million, or a loss of $0.65 per basic and diluted share for the nine months ended September 30, 2010. The $11.5 million reduction in net loss in 2011 was due primarily to $5.5 million of lower expenses related to devoting fewer resources to our protease inhibitor and non-nucleoside polymerase inhibitor programs during 2011, $3.1 million lower salaries and personnel related costs, $2.6 million of lower costs related to the timing of clinical trials of IDX184 and $2.2 million of non-recurring restructuring expenses in 2010. Offsetting these amounts was an increase of $3.7 million in expenses related to the preclinical development of our NS5A drug candidates.
2011 Financial Guidance
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 satisfy its cash needs into at least the second quarter of 2012. This guidance assumes no additional milestone payments, license fees, reimbursement for development programs and no financing activities.
Operational Highlights
IDX184 Program
The Company’s lead program, IDX184, is a pan-genotypic oral nucleotide polymerase inhibitor that has shown potent antiviral activity in both preclinical and clinical studies. IDX184 is a proprietary liver-targeted prodrug of 2'-methyl guanosine monophosphate with a high barrier to resistance in vitro.
In July 2011, the Company initiated enrollment of 100 HCV-infected patients into a 12-week Phase IIb clinical trial of IDX184 in combination with pegylated interferon and ribavirin. The Company will report an interim analysis from this study after the first 30 patients have completed 28 days of treatment. The Company initiated dosing of the first 20 patients, and is currently enrolling the remaining ten patients. There have been no safety signals to date. Based on the current rate of enrollment, the Company expects to complete one month dosing of the first 30 patients in December 2011, and anticipates releasing interim one month safety and antiviral activity data for the first 30 patients from the Phase IIb trial early in the first quarter of 2012.
Discovery Programs
IDX719, the Company’s lead NS5A inhibitor candidate, has shown potent and broad genotypic activity. The Company expects to submit regulatory filings by year end 2011 and begin the clinical program in early 2012.
The Company’s novel nucleotide program continues to make significant progress and has generated many preclinical compounds. Given the progress of the Company’s nucleotide prodrugs, the Company is reallocating discovery and development resources from its protease inhibitor program to the nucleotide program. The Company will continue to evaluate potential partnerships and licensing agreements for its protease inhibitor drug candidates and related intellectual property.
Upcoming Meetings/Conferences
American Association for the Study of Liver Diseases Meeting (AASLD)
Idenix will present two posters at AASLD in San Francisco, California:
- McCarville, et al, “Patterns of NS5B mutations in a 3-day clinical trial of HCV non-nucleoside polymerase inhibitor IDX375" will be presented in a poster session on November 5, 2011 starting at 2:00pm PT
- McCarville, et al, “In vivo resistance profile of IDX320 after 3 days of dosing in genotype 1 HCV-infected patients” will be presented in a poster session on November 5, 2011 starting at 2:00pm PT
HEP DART Meeting
Idenix will have a presentation at HEP DART in Koloa, Hawaii:
- Mayers, D. and Standring, D., “Combination DAA Strategies to Cure HCV” will be featured as an oral presentation on December 4, 2011
Credit Suisse 2011 Healthcare Conference
Idenix management will present a corporate overview at the Credit Suisse 2011 Healthcare Conference on November 9, 2011 at 4:30 p.m. MST at the Arizona Biltmore Hotel, Phoenix.
The live and archived webcast of the company presentation can be accessed under “Calendar of Events” in the Idenix Investor Center at www.idenix.com. Please log in approximately 5-10 minutes before the event to ensure a timely connection. The archived replay will be available on the Idenix website for two weeks following the conference.
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 chronic hepatitis C infection. For further information about Idenix, please refer to www.idenix.com.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 4:30 p.m. ET. To access the call, please dial (877) 640-9809 (U.S./Canada) or (914) 495-8528 (International) and enter passcode 22292830. A slide presentation will accompany the conference call and can be accessed on the Investor section of the Idenix website at www.idenix.com. Please log on approximately 10 minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A replay of the conference call and webcast will be available until November 16, 2011, by dialing (855) 859-2056 (U.S./Canada) or (404) 537-3406 (International) and enter the passcode 22292830.
