BRISBANE, Calif., Aug. 6 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from operations for the second quarter and six months ended June 30, 2009. InterMune reported a net loss for the second quarter of 2009 of $36.7 million, or $0.81 per share, compared with a net loss of $29.6 million, or $0.76 per share, in the second quarter of 2008.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said, "The last several months have been exceptionally productive for InterMune and the coming months promise to be even more so. Regarding pirfenidone, we have made excellent progress on the preparation of our New Drug Application (NDA) for pirfenidone which we now expect to submit in the fourth quarter. It has taken more time than we anticipated to integrate the advice of a host of external expert advisors and to take every possible step to develop the strongest possible file that positions us for potential approval in the first review cycle. Our Marketing Authorization Application (MAA) is also progressing very well; we had a successful pre-submission meeting with the EMEA in July and we expect to submit the MAA for pirfenidone in the first quarter of 2010."
Mr. Welch continued, "Regarding ITMN-191 (R7227), we announced exciting news today on several important aspects of the program, specifically: the successful completion of six-month and nine-month chronic toxicology studies in rats and monkeys, respectively which clear the way for our Phase 2 and Phase 3 clinical programs; our expectation that our partner Roche will enroll the first patient in our Phase 2b study of ITMN-191 in combination with standard of care in August; our plans to start a Phase 1b MAD study of ITMN-191 in combination with low dose ritonavir in HCV patients in the third quarter; and finally, our plans to present the results of all seven cohorts of the INFORM-1 study at the AASLD meeting on November 3."
Results for the Three Months Ended June 30, 2009
InterMune reported total revenue in the second quarter of 2009 of $7.9 million, compared with total revenue of $8.1 million in the second quarter of 2008. Total revenue in the second quarter of 2009 primarily consisted of Actimmune(R) (interferon gamma-1b) revenue of $7.1 million, compared with $7.3 million in the same quarter of 2008, a decrease of approximately 2 percent, 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 second quarter of 2009 were $22.9 million compared with $25.4 million in the second quarter of 2008, a decrease of approximately 10 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 $8.5 million in the second quarter of 2009, compared with $7.1 million in the same period a year earlier, an increase of approximately 20 percent, primarily attributed to costs related to preparation for the anticipated commercialization of pirfenidone.
InterMune recorded a loss on extinguishment of debt of $9.5 million, of which $8.9 million was non-cash, in the second quarter of 2009 in connection with the April 2009 exchange of approximately $32.3 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 2.1 million shares of common stock were issued in connection with the transaction.
As of June 30, 2009, InterMune had cash, cash equivalents and available-for-sale securities of approximately $145.5 million, compared with $154.7 million as of December 31, 2008.
Results for the Six Months Ended June 30, 2009
InterMune also reported results from operations for the six months ended June 30, 2009. The net loss for the period was $78.7 million, or $1.83 per share, compared with a net loss of $58.7 million, or $1.51 per share, in the first six months of 2008.
Total revenue in the first half of 2009 was $14.8 million, compared with total revenue of $17.4 million in the same period of 2008, a decrease of 15 percent. Actimmune revenue totaled $13.1 million in the first six months of 2009, compared with $15.8 million of Actimmune revenue in the first six months of 2008, a decrease of approximately 17 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 $1.6 million in the first six months of 2009, unchanged from the same period of 2008.
R&D expenses were $47.4 million in the first six months of 2009, a 10 percent decrease compared to $52.4 million in the same period of 2008. This decrease was primarily due to the completion of the Phase 3 CAPACITY program in early 2009, partially offset by expenses associated with the RECAP pirfenidone study and expenses associated with the preparation of the NDA and MAA for pirfenidone. G&A expenses of $17.0 million in the first half of 2009 were approximately 17 percent higher than $14.5 million in the first six months of 2008, primarily reflecting costs related to preparation for the anticipated commercialization of pirfenidone. First half 2009 expenses 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 Financial Accounting Standards Board Staff Position APB 14-1, "Accounting for Convertible Debt Instruments That May Be Settled In Cash Upon Conversion (Including Partial Cash Settlement)" (FSP APB 14-1) and recorded additional interest expense for the second quarter of 2009 of $1.1 million and $2.7 million for the first half of 2009. FSP APB 14-1 requires retrospective application upon adoption; therefore, net losses attributable to InterMune for the second quarter and first half of 2008 have been adjusted from those which were previously reported to reflect additional interest expense of $2.9 million and $5.6 million, respectively.
Clinical Development Highlights
Pirfenidone:
- InterMune today reported that an abstract on the CAPACITY data, focused on the safety profile of pirfenidone, has been accepted for an oral presentation at the 2009 European Respiratory Society (ERS) Annual Congress in Vienna, Austria. The presentation will be on September 14 at 3:30 p.m. CEST in the Stolz Room of the Vienna Conference Center (Messe Wien).
- Previously announced results from the Phase 3 CAPACITY program for pirfenidone in IPF were presented in an oral late-breaker session on May 19 at the International Conference of the American Thoracic Society (ATS) in San Diego:
- CAPACITY 2 demonstrated a statistically significant effect on both the primary endpoint of change in percent predicted FVC at Week 72 and secondary endpoints of progression-free survival and categorical change in percent predicted FVC.
- While CAPACITY 1 did not achieve statistical significance on the primary endpoint at Week 72, the results were generally consistent with and supportive of CAPACITY 2.
- Treatment effect in the CAPACITY studies was also generally consistent with the Phase 3 study of pirfenidone in IPF patients conducted by Shionogi & Co. Ltd. in Japan.
- Pirfenidone was safe and generally well tolerated in both CAPACITY studies. There was no difference in SAEs and fewer deaths were observed with pirfenidone compared to placebo. Adverse events were comparable to previous clinical studies of pirfenidone.
- New, pre-specified exploratory efficacy data from CAPACITY pertaining to dose-effect relationships, mean change in FVC volume and Six-Minute Walk Test distance that was presented provided valuable insight into the estimate of treatment effect in the combined populations.
ITMN-191:
- InterMune announced today the successful completion of chronic toxicology studies in two specific species: a six-month chronic toxicology study in rats and a nine-month chronic toxicology study in monkeys. There were no significant drug-related findings in either study. These results provide the necessary preclinical data to conduct the intended Phase 2 and Phase 3 clinical programs for ITMN-191.
- InterMune expects that the first patient will be enrolled in August in the Phase 2b study of ITMN-191 in combination with standard of care. The Phase 2b trial will study both twice-daily (600mg and 900mg q12h) and three-times-daily regimens (300mg q8h) and both 12-week and 24-week treatment durations.
