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Dan Welch, President and Chief Executive Officer of InterMune, said, "Thefirst several months of 2008 have been an exciting period for InterMune.Results from four dose cohorts in the important Phase 1bmultiple-ascending-dose(MAD) study of ITMN-191 suggest a very competitiveproduct profile for ITMN-191. In early April, we reported substantial overallprogress on the ITMN-191 program and look forward to our next importantdevelopment step in this quarter -- the initiation of a 14-day triplecombination study of ITMN-191 with Pegasys(R) and ribavirin. The balance ofthis year and early 2009 will be a pivotal period during which we expect tocomplete our MAD study of ITMN-191, gain new experience with the compound intriple combination therapy and report results from the Phase 3 CAPACITYprogram for pirfenidone."
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InterMune reported total revenue in the first quarter of 2008 of$9.3 million, compared with total revenue of $20.3 million in thefirst quarter of 2007. Total revenue in the first quarter of 2008 primarilyconsisted of Actimmune(R) (interferon gamma-1b) revenue of $8.5 million,compared with $19.5 million in the same quarter of 2007, a decrease ofapproximately 56%, reflecting lower off-label physician prescriptions ofActimmune for the treatment of idiopathic pulmonary fibrosis (IPF), whichInterMune does not promote.
Research and development (R&D) expenses in the first quarter of 2008 were$27.2 million compared with $29.4 million in the first quarter of 2007, adecrease of approximately 7%. General and administrative (G&A) expenses were$7.5 million in the first quarter of 2008, compared with $9.5 million in thesame period a year earlier, a decrease of approximately 21%.
As of March 31, 2008, InterMune had cash, cash equivalents andavailable-for-sale securities of approximately $211.0 million, compared with$235.3 million at December 31, 2007.
Guidance for 2008 Operating Expenses
InterMune today reiterated its forward-looking guidance with respect tooperating expenses in 2008.
For the year ending December 31, 2008, R&D expense is anticipated to be ina range of approximately $100 to $110 million, net of development costreimbursements under the Roche collaboration. G&A expense is anticipated tobe in a range of approximately $25 to $30 million.
Key Development Program Milestones
InterMune today noted the upcoming milestones with respect to its keydevelopment programs.
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EDT to discussits financial results for the first quarter 2008, its forward-lookingfinancial guidance and its clinical development programs. Interestedinvestors and others may participate in the conference call by dialing888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 44837583.A replay of the webcast and teleconference will be available approximatelythree hours after the call.
To access the webcast, please log on to the company's website athttp://www.intermune.com at least 15 minutes prior to the start of the call toensure adequate time for any software downloads that may be required.
The teleconference replay will be available for 10 business days followingthe call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291(international), and entering the conference ID# 44837583. The webcast willremain available on the company's website until the next earnings call.
About InterMune
InterMune is a biotechnology company focused on the res