[Nothing newsworthy here. Total revenue in 1Q07 was $24.8M, but the amount from Tyzeka sales is not disclosed. Guidance for the cash balance at the end of 2007 remains the same: $100-100M (excluding the milestone that might be received for getting NM283 into phase-3).]
CAMBRIDGE, Mass., April 26 /PRNewswire-FirstCall/ -- Idenix Pharmaceuticals, Inc. (Nasdaq: IDIX ), a biopharmaceutical company engaged in the discovery, development and commercialization of drugs for the treatment of human viral and other infectious diseases, today reported unaudited financial results for the first quarter ended March 31, 2007. At March 31, 2007, Idenix's cash, cash equivalents and marketable securities totaled $161.9 million.
For the first quarter ended March 31, 2007, Idenix reported total revenues of $24.8 million, compared with total revenues of $13.1 million in the first quarter of 2006. Total revenues for the first quarter of 2007 consist of reimbursement by Novartis Pharma AG of expenses incurred by Idenix in connection with the development of Idenix's product and product candidates, TYZEKA® (telbivudine) and valtorcitabine for the treatment of hepatitis B and valopicitabine (NM283) for the treatment of hepatitis C; the amortization of the up-front fees received by Idenix in connection with Novartis' license of telbivudine, valtorcitabine and valopicitabine; a regulatory milestone payment from Novartis; and product sales. Idenix reported 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, compared to a net loss of $17.2 million, or a loss of $0.31 per basic and diluted share, for the first quarter ended March 31, 2006. The increase in total revenue and decrease in net loss for the period ended March 31, 2007 compared to the same period in 2006 are primarily related to the recognition of a milestone payment for TYZEKA/SEBIVO® (telbivudine) from Novartis. Business Highlights
Accomplishments realized to date in 2007 include:
* Telbivudine, which is marketed as TYZEKA in the United States and SEBIVO in the rest of the world, has now received regulatory approval in more than 15 countries around the world. In the first quarter of 2007, SEBIVO was approved in China, one of the largest hepatitis B markets, triggering a regulatory milestone payment from Novartis. In February, the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of SEBIVO in Europe; a final decision from the European Commission is pending. Regulatory decisions are also pending in additional regions around the world.
* In April, data was presented from two phase IIb studies of valopicitabine in combination with pegylated interferon in treatment- naive and treatment-refractory hepatitis C patients at the annual meeting of the European Association for the Study of the Liver (EASL). The company is now investigating the triple combination regimen of valopicitabine, pegylated interferon and ribavirin compared to standard of care (pegylated interferon and ribavirin) in a 12-week study. This study is fully enrolled with 117 patients dosed and, to date, there have been only three discontinuations.
* In April, an electronic investigational new drug (eIND) application for IDX899, a non-nucleoside reverse transcriptase inhibitor (NNRTI) drug candidate for the treatment of HIV, was filed to support a phase I study in healthy volunteers.
"We are pleased with the speed at which regulatory approvals are being received for TYZEKA/SEBIVO around the world," said Jean-Pierre Sommadossi, Ph.D., chairman and chief executive officer of Idenix. "As we work with our partner Novartis to successfully commercialize TYZEKA in the United States and prepare for the potential launch of SEBIVO in the European Union, we are also focused on defining a clear development path for valopicitabine and building our pipeline with novel hepatitis C and HIV drug candidates. We believe the filing of an eIND for IDX899 is yet another example of the strength of our comprehensive discovery program in producing next-generation antiviral therapeutics."
2007 Financial Guidance
The company continues to expect to end 2007 with between $100 million and $110 million of cash, cash equivalents and marketable securities. Included within this guidance are $20 million in regulatory approval milestone payments from Novartis Pharma AG related to TYZEKA/SEBIVO (telbivudine 600mg tablets), $10 million of which was received in April 2007. The remaining milestone payment is related to regulatory approval of telbivudine in the European Union, which the company anticipates receiving in the second quarter of this year.
Conference Call Information
Idenix will hold a conference call today at 4:30 p.m. ET. To access the call please dial 800-774-5358 U.S./Canada or 706-758-9475 International and enter passcode 6302807 or to listen to a live webcast of the call, go to "Calendar of Events" in the Idenix Investor Center at http://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 from 6:00 p.m. ET on April 26, 2007 until 11:30 p.m. ET on May 10, 2007. To access the replay, please dial 800-642-1687 U.S./Canada or 706-645-9291 International and enter the passcode 6302807.
About Idenix
Idenix Pharmaceuticals, Inc., headquartered in Cambridge, Massachusetts, is a biopharmaceutical company engaged in the discovery, development and commercialization 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 B virus, hepatitis C virus and HIV. For further information about Idenix, please refer to http://www.idenix.com. <<
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