Nov. 5, 2009 (PR Newswire) -- BRISBANE, Calif., Nov. 5 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from operations for the third quarter and nine months ended September 30, 2009. InterMune reported a net loss for the third quarter of 2009 of $8.8 million, or $0.19 per share, compared with a net loss of $14.0 million, or $0.36 per share, in the third quarter of 2008.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "The third quarter and recent weeks have been a period of exceptional progress and accomplishment for InterMune. As announced yesterday, we submitted our New Drug Application (NDA) for pirfenidone, the first NDA ever submitted for a medicine for patients who suffer from idiopathic pulmonary fibrosis (IPF). We also made excellent progress on our hepatitis C virus (HCV) protease inhibitor ITMN-191 (RG7227) including the initiation of our Phase 2b clinical study and the presentation of the promising results of our novel clinical study of two direct antiviral agents, INFORM-1, at the AASLD meeting earlier this week." Mr. Welch continued, "Our efforts are now focused on the submission of the MAA for pirfenidone, the support of the NDA and the work to be prepared to bring pirfenidone to patients, should our NDA and/or MAA be granted approval by the regulatory authorities in the United States and Europe, respectively."
Results for the Three Months Ended September 30, 2009
InterMune reported total revenue in the third quarter of 2009 of $27.3 million, compared with total revenue of $23.3 million in the third quarter of 2008. Total revenue in the third quarter of 2009 primarily consisted of revenue from the collaboration with Roche for the development of protease inhibitors, including ITMN-191, which totaled $20.8 million in the third quarter of 2009, compared with $15.8 million in the third quarter of 2008. Third quarter 2009 collaboration revenue included a $20.0 million milestone payment from Roche associated with initiation of the Phase 2b clinical trial of ITMN-191 in patients chronically infected with HCV. Collaboration revenue in the third quarter a year earlier included a $15.0 million development milestone payment from Roche.
InterMune reported Actimmune® (interferon gamma-1b) revenue in the third quarter of 2009 of $6.5 million, compared with $7.5 million in the same quarter of 2008, a decrease of approximately 15 percent, reflecting lower off-label physician prescriptions of Actimmune for the treatment of IPF, which InterMune does not promote.
Research and development (R&D) expenses in the third quarter of 2009 were $20.6 million compared with $25.6 million in the third quarter of 2008, a decrease of approximately 20 percent, reflecting completion of the CAPACITY clinical trials in early 2009, partially offset by expenses associated with the RECAP extension study and the preparation of the NDA and MAA for pirfenidone. General and administrative (G&A) expenses were $9.9 million in the third quarter of 2009, compared with $8.2 million in the same period a year earlier, an increase of approximately 20 percent, primarily attributed to costs related to preparation for the potential commercialization of pirfenidone, which is subject to regulatory approvals.
InterMune recorded a non-cash loss on extinguishment of debt of $0.7 million in the third quarter of 2009 in connection with the September 2009 exchange of approximately $3.8 million of its 0.25% Convertible Senior Notes due 2011 held by certain of its debt holders for shares of the company's common stock. A total of approximately 250,000 shares of common stock were issued in connection with the transaction.
As of September 30, 2009, InterMune had cash, cash equivalents and available-for-sale securities of approximately $139.7 million, compared with $154.7 million as of December 31, 2008.
Results for the Nine Months Ended September 30, 2009
InterMune also reported results from operations for the nine months ended September 30, 2009. The net loss for the period was $87.4 million, or $2.00 per share, compared with a net loss of $72.7 million, or $1.87 per share, in the first nine months of 2008.
Total revenue in the first nine months of 2009 was $42.1 million, compared with total revenue of $40.8 million in the same period of 2008, an increase of 3 percent. Actimmune revenue totaled $19.6 million in the first nine months of 2009, compared with $23.3 million of Actimmune revenue in the first nine months of 2008, a decrease of approximately 16 percent, reflecting lower off-label sales of Actimmune for the treatment of IPF, which InterMune does not promote. Revenue from the collaboration with Roche was $22.5 million in the first nine months of 2009, compared with $17.5 million in the same period of 2008. Collaboration revenue in the first nine months of 2009 included a $20.0 million milestone payment from Roche in connection with the start of the Phase 2b clinical trial program of ITMN-191, which was initiated in August. Collaboration revenue in the first nine months of 2008 included a $15.0 million development milestone payment received in the third quarter of 2008.
R&D expenses were $68.0 million in the first nine months of 2009, a 13 percent decrease compared to $78.0 million in the same period of 2008. This decrease in R&D expenses was primarily due to the completion of the Phase 3 CAPACITY program in early 2009, partially offset by increased expenses associated with: the RECAP pirfenidone study, the INFORM-1 and Phase 2b studies with ITMN-191 and the preparation of the NDA and MAA for pirfenidone. G&A expenses of $26.9 million in the first nine months of 2009 were approximately 19 percent higher than $22.7 million in the first nine months of 2008, primarily reflecting costs related to preparation for the potential commercialization of pirfenidone, which is subject to regulatory approvals. Expenses in the first nine months of 2009 included a milestone payment of $13.5 million for pirfenidone made to Marnac/KDL in accordance with the pirfenidone purchase agreement and InterMune's decision to submit NDA and MAA filings for pirfenidone.
On January 1, 2009, the company adopted guidance in the Debt Topic of the Financial Accounting Standards Board ("FASB") Accounting Standards Codification ("ASC"), formerly FASB Staff Position APB 14-1, "Accounting for Convertible Debt Instruments That May Be Settled In Cash Upon Conversion (Including Partial Cash Settlement)," and recorded additional interest expense for the third quarter of 2009 of $1.0 million and $3.7 million for the first nine months of 2009. This guidance requires retrospective application upon adoption; therefore, net losses attributable to InterMune for the third quarter and first nine months of 2008 have been adjusted from those which were previously reported to reflect additional interest expense of $1.5 million and $6.0 million, respectively.
Clinical Development Highlights - Third Quarter and Recent Events
Pirfenidone:
-- On November 4, InterMune announced that it had submitted an electronic
NDA with the U.S. Food and Drug Administration (FDA) seeking approval to
market pirfenidone for the treatment of patients with IPF. Pirfenidone
has been granted both "Fast Track" and Orphan Drug designations by the
FDA.
-- An oral presentation focused on the safety profile of pirfenidone was
presented at the European Respiratory Society (ERS) Annual Congress in
Vienna, Austria on September 14. Safety data from four clinical studies
-- CAPACITY 1, CAPACITY 2, RECAP and a long-term open-label study --
showed that treatment with pirfenidone was safe and generally well
tolerated.
ITMN-191 (RG7227)
-- On November 3, results of INFORM-1 were presented at the meeting of the
American Association for the Study of the Liver (AASLD).
