BRISBANE, Calif., May 1 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from operations for the first quarter ended March 31, 2008. InterMune reported a net loss for the first quarter of 2008 of $26.3 million, or $0.68 per share, compared with a net loss of $20.8 million, or $0.61 per share, in the first quarter of 2007.
Dan Welch, President and Chief Executive Officer of InterMune, said, "The first several months of 2008 have been an exciting period for InterMune. Results from four dose cohorts in the important Phase 1b multiple-ascending-dose(MAD) study of ITMN-191 suggest a very competitive product profile for ITMN-191. In early April, we reported substantial overall progress on the ITMN-191 program and look forward to our next important development step in this quarter -- the initiation of a 14-day triple combination study of ITMN-191 with Pegasys(R) and ribavirin. The balance of this year and early 2009 will be a pivotal period during which we expect to complete our MAD study of ITMN-191, gain new experience with the compound in triple combination therapy and report results from the Phase 3 CAPACITY program for pirfenidone."
InterMune reported total revenue in the first quarter of 2008 of $9.3 million, compared with total revenue of $20.3 million in the first quarter of 2007. Total revenue in the first quarter of 2008 primarily consisted of Actimmune(R) (interferon gamma-1b) revenue of $8.5 million, compared with $19.5 million in the same quarter of 2007, a decrease of approximately 56%, reflecting lower off-label physician prescriptions of Actimmune for the treatment of idiopathic pulmonary fibrosis (IPF), which InterMune 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, a decrease 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 the same period a year earlier, a decrease of approximately 21%.
As of March 31, 2008, InterMune had cash, cash equivalents and available-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 to operating expenses in 2008.
For the year ending December 31, 2008, R&D expense is anticipated to be in a range of approximately $100 to $110 million, net of development cost reimbursements under the Roche collaboration. G&A expense is anticipated to be in a range of approximately $25 to $30 million.
Key Development Program Milestones
InterMune today noted the upcoming milestones with respect to its key development programs.
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EDT to discuss its financial results for the first quarter 2008, its forward-looking financial guidance and its clinical development programs. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 44837583. A replay of the webcast and teleconference will be available approximately three hours after the call.
To access the webcast, please log on to the company's website at http://www.intermune.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required.
The teleconference replay will be available for 10 business days following the 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 will remain available on the company's website until the next earnings call.
About InterMune
InterMune is a biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and hepatology. InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis (IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a possible therapeutic candidate for the treatment of patients with IPF and a research program focused on small molecules for pulmonary disease. The hepatology portfolio includes the HCV protease inhibitor compound ITMN-191 (referred to as R7227 within the Roche research and development programs) in Phase 1b, a second-generation HCV protease inhibitor research program, and a research program evaluating a new target in hepatology. For additional information about InterMune and its R&D pipeline, please visit http://www.intermune.com.
Forward-Looking Statements
This news release contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended, that reflect InterMune's judgment and involve risks and uncertainties as of the date of this release, including without limitation the statements related to anticipated future financial results and product development. All forward-looking statements and other information included in this press release are based on information available to InterMune as of the date hereof, and InterMune assumes no obligation to update any such forward-looking statements or information. InterMune's actual results could differ materially from those described in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, but are not limited to, those discussed in detail under the heading "Risk Factors" in InterMune's most recent annual report on Form 10-K filed with the SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with the SEC, including the following: (i) the risk that physician prescriptions of Actimmune for the treatment of IPF, an indication for which Actimmune has not been approved by the FDA, have declined following the March 2007 termination of the Phase 3 INSPIRE trial of Actimmune in IPF and InterMune's revenue is expected to continue to decline; (ii) risks related to regulation by the FDA and other agencies with respect to InterMune's communications with physicians concerning Actimmune for the treatment of IPF; (iii) reimbursement risks associated with third-party payors; (iv) risks related to whether InterMune is able to obtain, maintain and enforce patents and other intellectual property; (v) risks related to significant regulatory, supply and competitive barriers to entry; (vi) risks related to the uncertain, lengthy and expensive clinical development and regulatory process, including having no unexpected safety, toxicology, clinical or other issues; (vii) risks related to achieving positive clinical trial results; (viii) risks related to timely patient enrollment and retention in clinical trials; (ix) the results of the InterMune CAPACITY trials of pirfenidone may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone; (x) the results as reported by Shionogi concerning their Phase 3 trial may differ from those published or presented in a peer-reviewed forum; and (xi) risks related to the company's manufacturing strategy, which relies on third-party manufacturers and which exposes InterMune to additional risks where it may lose potential revenue. The risks and other factors discussed above should be considered only in connection with the fully discussed risks and other factors discussed in detail in the Form 10-K and InterMune's other periodic reports filed with the SEC, all of which are available via InterMune's web site at http://www.intermune.com.
Actimmune(R) is a registered trademark of InterMune, Inc. Pegasys(R) and Copegus(R) are registered trademarks of Roche.
SOURCE InterMune, Inc.
