InterMune Inc. (ITMN) filed Quarterly Report for the period ended 2009-09-30.
InterMune Pharmaceuticals Inc. develops and commercializes innovative products for the treatment of serious pulmonary and infectious diseases and congenital disorders. The company markets ACTIMMUNE for chronic granulomatous disease and osteopetrosis. The company has active development programs underway for the other disease areas several of which are in mid-or advanced-stage human testing known as clinical trials. Intermune Inc. has a market cap of $632.7 million; its shares were traded at around $13.72 with and P/S ratio of 13.2.
Highlight of Business Operations:
Total revenue was $27.3 million and $23.3 million for the three-month periods ended September 30, 2009 and 2008, respectively, representing an increase of 17%. This increase was attributable to the recognition of a $20.0 million milestone payment from Roche in the third quarter of 2009 associated with the initiation of the Phase 2b clinical trial of ITMN 191 as compared to recognition of a $15.0 million milestone receipt in the third quarter of 2008 under the same collaboration agreement with Roche. Total revenue was $42.1 million and $40.8 million for the nine-month periods ended September 30, 2009 and 2008, respectively, representing an increase of 3%. This increase was attributable to recognition of the larger milestone receipt noted above in 2009, partially offset by a decrease in sales of Actimmune of approximately $3.7 million, or 16%. In early March 2007, we announced that our Phase III INSPIRE program for Actimmune in IPF had been discontinued and that future Actimmune revenue was expected to decline. For the three- and nine-month periods ended September 30, 2009 and 2008, sales of Actimmune accounted for all of our net product revenue. A majority of this revenue was derived from physicians’ prescriptions for the off-label use of Actimmune in the treatment of IPF.
Cost of goods sold included product manufacturing costs, royalties and distribution costs. Cost of goods sold were $1.0 million and $1.4 million for the three-month periods ended September 30, 2009 and 2008, respectively. The gross margin percentage for our products was 84% and 81% for these periods in 2009 and 2008, respectively. For the nine months ended September 30, 2009, cost of goods sold were $5.7 million compared with $7.3 million for the same period last year. The gross margin percentage for our products was 70% and 69% for these periods in 2009 and 2008, respectively. During the second quarter of 2008, we recorded a $0.7 million charge for excess inventory to reflect our decision during the latter part of that quarter to ship only current dated product that had recently been received from Boehringer Ingelheim (“BI”) under the new supply agreement. The decline in dollar value of cost of goods sold for the three- and nine-months ended September 30, 2009 compared to the same periods last year reflects the declining Actimmune revenue.
Research and development expenses were $20.6 million and $25.6 million for the three-month periods ended September 30, 2009 and 2008, respectively, representing a decrease of $5.0 million, or 20%. Research and development expenses were $68.0 million and $78.0 million for the nine-month periods ended September 30, 2009 and 2008, respectively, representing a decrease of $10.1 million or 13%. The decreases in spending for the three- and nine-month periods ended September 30, 2009 compared with the same periods in 2008 primarily reflect the completion of the CAPACITY clinical trials late in 2008 and the amendment to the Roche collaboration agreement entered into in November 2008 whereby Roche funds certain of our research activities.
General and administrative expenses were $9.9 million for the three-month period ended September 30, 2009 compared with $8.2 million for the three-month period ended September 30, 2008. For the nine-month periods ended September 30, 2009 and 2008, general and administrative expenses were $26.9 million and $22.7 million, respectively, representing an increase of $4.2 million, or 18%. The increased spending for the three- and nine-month periods ended September 30, 2009 compared with the same periods in 2008 is primarily attributed to costs related to preparation for the potential commercialization of pirfenidone. In 2009, including stock-based compensation, we expect general and administrative expenses to be in a range of $35.0 million to $40.0 million, which includes an estimate of approximately $5.0 million for the above mentioned expenses.
Interest expense decreased to $2.7 million in the third quarter of 2009 compared with $3.0 million for the third quarter of 2008 and decreased to $7.9 million for the nine-months ended September 30, 2009 compared with $10.1 million for the comparable period in 2008. Each period reflects interest expense recorded in connection with our liability under the government settlement reached in October 2006. Interest expense for the nine-months ended September 30, 2008 also includes interest on our $170.0 million 0.25% convertible notes due in March 2011 (the “2011 Notes”), including the amortization of related debt issuance costs. On June 24, 2008, we issued $85.0 million in aggregate principal amount of 5.00% Convertible Senior Notes due 2015 (the “2015 Notes”) to certain holders of our existing 2011 Notes in exchange for $85.0 million in aggregate principal amount of their 2011 Notes.
Cash used in operating activities was $87.3 million during the nine-month period ended September 30, 2009, comprised primarily of a net loss of $87.4 million. Significant changes in working capital consisted of a decrease in other accrued liabilities of approximately $10.0 million, primarily consisting of a $4.4 million accelerated payment we made to the Department of Justice in March 2009 and $19.1 million in aggregate payments we made to Roche under our collaboration agreement with them, partially offset by a decline in accrued clinical trial costs of approximately $6.7 million. Other working capital changes included increases to accounts receivable and inventories of approximately $2.0 million and $1.5 million, respectively. Details concerning the loss from operations can be found above in this Report under the heading “Results of Operations.”
Rate This Article: |
  |