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Dan Welch, Chairman, Chief Executive Officer and President of InterMunesaid, "Third quarter and recent events have highlighted our significantprogress on pirfenidone and ITMN-191. On October 16, Shionogi's Japanese NDAfor pirfenidone was approved, making pirfenidone the first drug approved foridiopathic pulmonary fibrosis (IPF) in any major market in the world. Wereported exceptional patient retention in our Phase 3 CAPACITY program forpirfenidone in IPF and we set the expectation for announcement of top-lineresults from CAPACITY in January or February of 2009. With ITMN-191, weremain committed to announcing top-line results of our triple combinationstudy of ITMN-191 with Pegasys(R) (pegylated interferon alfa-2a) andCopegus(R) (ribavirin) during this quarter."
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Results for Third Quarter 2008
InterMune reported total revenue in the third quarter of 2008 of $23.3million, compared with total revenue of $11.4 million in the third quarter of2007. Total revenue in the third quarter of 2008 primarily consisted ofrevenue from the collaboration with Roche for the development of proteaseinhibitors, including ITMN-191 (R7227), which totaled $15.8 million in thethird quarter of 2008, compared with $0.8 million in the same quarter of 2007.Third quarter 2008 collaboration revenue included a $15.0 million developmentmilestone payment from Roche. Third quarter 2008 total revenue also includedActimmune(R) (interferon gamma-1b) revenue of $7.5 million, compared with$10.6 million of Actimmune revenue in the same quarter of 2007, a decrease ofapproximately 29%, reflecting lower off-label physician prescriptions ofActimmune for the treatment of idiopathic pulmonary fibrosis (IPF), whichInterMune does not promote. Third quarter 2008 Actimmune revenue increasedmodestly over that of second quarter 2008 reflecting an 18% price increasetaken in July.
Research and development (R&D) expenses in the third quarter of 2008 were$25.7 million compared with $23.4 million in the third quarter of 2007, anincrease of 10%. General and administrative (G&A) expenses were $7.9 millionin the third quarter of 2008, compared with $6.4 million in the same period ayear earlier, an increase of 23%.
As of September 30, 2008, InterMune had cash, cash equivalents andavailable-for-sale securities of approximately $185.6 million, compared with$188.3 million as of June 30, 2008.
Results for the Nine Months Ended September 30, 2008
InterMune also reported results from operations for the nine months endedSeptember 30, 2008. The net loss for the period was $65.4 million, or $1.68per share, compared with a net loss of $63.7 million, or $1.85 per share, inthe first nine months of 2007.
Total revenue in the first nine months of 2008 was $40.8 million, comparedwith total revenue of $57.1 million in the same period of 2007, a decrease of29%. Actimmune revenue totaled $23.3 million in the first nine months of2008, compared with $44.6 million of Actimmune revenue in the first ninemonths of 2007, a decrease of approximately 48%, reflecting lower off-labelsales of Actimmune for the treatment of IPF, which InterMune does not promote.Revenue from the collaboration with Roche was $17.5 million in the first ninemonths of 2008, compared with $12.5 million in the same period of 2007.Collaboration revenue in the first nine months of 2008 consisted of a $15.0million development milestone and $2.5 million in amortization of the initialupfront and manufacturing milestone payments.
R&D expenses were $78.3 million in the first nine months of 2008, a 3%decrease compared to $80.8 million in the same period of 2007. G&A expensesof $22.5 million in the first nine months of 2008 were approximately 2% lowerthan $23.0 million in the first nine months of 2007.
Guidance for 2008 Operating Expenses
InterMune today reiterated its guidance with respect to operating expensesin 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.
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EST to discussits financial results for the third quarter and first nine months of 2008, itsforward-looking financial guidance and its clinical development programs.Interested investors and others may participate in the conference call bydialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID#71184785. A replay of the webcast and teleconference will be availableapproximately three 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# 71184785. The webcast willremain available on the company's website until the next earnings call.
About InterMune
InterMune is a biotechnology company focused on the research, developmentand 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 portfolioincludes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as apossible therapeutic candidate for the treatment of patients with IPF and aresearch program focused on small molecules for pulmonary disease. Thehepatology portfolio includes the HCV protease inhibitor compound ITMN-191(referred to as R7227 at Roche) in Phase 1b, a second-generation HCV proteaseinhibitor research program, and a research program evaluating a new target inhepatology. 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 meaningof section 21E of the Securities Exchange Act of 1934, as amended, thatreflect InterMune's judgment and involve risks and uncertainties as of thedate of this release, including without limitation the statements related toanticipated future financial results and product development. All forward-looking statements and other information included in this press release arebased on information available to InterMune as of the date hereof, andInterMune assumes no obligation to update any such forward-looking statementsor information. InterMune's actual results could differ materially from thosedescribed in InterMune's forward-looking statements.
Factors that could cause or contribute to such differences include, butare 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 onMarch 14, 2008 (the "Form 10-K") and other periodic reports filed with theSEC, including the following: (i) the fact that physician prescriptions ofActimmune for the treatment of IPF, an indication for which Actimmune has notbeen approved by the FDA, have declined significantly following the March 2007termination of the Phase 3 INSPIRE trial of Actimmune in IPF and the risk thatInterMune's revenue will continue to decline as expected; (ii) risks relatedto regulation by the FDA and other agencies with respect to InterMune'scommunications with physicians concerning Actimmune for the treatment of IPF;(iii) reimbursement risks associated with third-party payors; (iv) risksrelated to whether InterMune is able to obtain, maintain and enforce patentsand 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, includinghaving no unexpected safety, toxicology, clinical or other issues; (vii) risksrelated to achieving positive clinical trial results; (viii) risks related totimely patient enrollment and retention in clinical trials; (ix) the resultsof the InterMune CAPACITY trials of pirfenidone may differ materially fromthose of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone and there canbe no assurance that the U.S. or European regulatory authorities will approvethe use of pirfenidone for the treatment of IPF; (x) the results as reportedby Shionogi concerning their Phase 3 trial may differ from those published orpresented in a peer-reviewed forum; and (xi) risks related to the company'smanufacturing strategy, which relies on third-party manufacturers and whichexposes InterMune to additional risks where it may lose potential revenue.The risks and other factors discussed above should be considered only inconnection with the fully discussed risks and other factors discussed indetail in the Form 10-K and InterMune's other periodic reports filed with theSEC, all of which are available via InterMune's web site at www.intermune.com.
Actimmune(R) is a registered trademark of InterMune, Inc. Pegasys(R) andCopegus(R) are registered trademarks of Roche.Third Quarter and Recent Highlights Pirfenidone: -- On October 16, Shionogi & Co., Ltd of Japan, which has rights to pirfenidone in Japan, reported approval of its j-NDA to market pirfenidone as Pirespa(R) in idiopathic pulmonary fibrosis (IPF). -- InterMune confirmed excellent study conduct in its Phase 3 CAPACITY program for pirfenidone in IPF, with 97% of surviving, transplant-free patients having completed their Week 72 Study Visit. -- InterMune today announced that all patients have now completed their final study visit scheduled for 30 days after treatment completion. Based on this timing, the company continues to expect to report top- line results from its Phase 3 CAPACITY program in January or in February of 2009. ITMN-191 (R7227): -- Announced in early September that InterMune had earned a $15 million development milestone under its development collaboration with Roche for ITMN-191. Under the terms of their 2006 collaboration agreement, the responsibility for the clinical program for ITMN-191 is now in the process of being transitioned to Roche which, starting in Phase 2, will have primary responsibility for completing the global development and registration program. -- At the meeting of the American Association for the Study of Liver Diseases (AASLD), InterMune presented eight posters on its hepatology programs, including its lead protease inhibitor for the treatment of patients chronically infected with the hepatitis C virus (HCV), ITMN-191. Among the highlights, InterMune reported: - Median viral kinetic results for ITMN-191 competitive with those published for other direct antiviral compounds when used in monotherapy for 14 days in treatment-naive patients chronically infected with hepatitis C virus (HCV) genotype 1. - Excellent safety and tolerability for ITMN-191 in all dosage regimens. - The in-vitro combination of ITMN-191 with the active moiety of polymerase inhibitor R7128 (Roche/Pharmasset) in a 14-day replicon clearance assay and in a 3-week colony formation assay resulted in clearance of the HCV replicon and reduced or suppressed the emergence of drug-resistant viral variants. These results suggest that the combination would likely result in significantly greater antiviral activity than has been observed with either of these agents in previous monotherapy trials.
SOURCE InterMune, Inc.
