InterMune Reports Third Quarter 2009 Financial Results and Business ...(- Pirfenidone ----------- Submi...),Health

Date:11/5/2009

- Pirfenidone ----------- Submission of pirfenidone MAA to EMEA Q1 2010 ------------------------------------- ------- ITMN-191 (RG7227) ---------------- Rapid Virologic Response (RVR) data from Phase 2b (12-week regimens) Q1 2010 ------------------------------------------------- ------- Initiate INFORM-2 program Q1 2010 ------------------------- ------- Initiate longer duration INFORM studies to evaluate SVR H1 2010 --------------------------------------------------- -------

Guidance for 2009 Revenue and Expenses

The company updated its 2009 financial guidance for revenue and operating expenses from the guidance initially provided on February 26, 2009.

Revenue: 2009 revenue, including Actimmune® and milestone payments from Roche, is expected to be in a range of approximately $45 to $50 million. Actimmune revenue represents approximately 50 percent of this revenue range.

Operating Expenses

    -- R&D expense:  anticipated to be in a range of approximately $90 to $100
       million, net of development cost reimbursements under the Roche
       collaboration.  Of this amount, approximately 60 percent is attributed
       to pirfenidone which includes expenses for CAPACITY, RECAP, the
       preparation and support of NDA and MAA submissions and manufacturing.

       Approximately 35 percent of the R&D expense is attributed to the
       company's one-third share of all development expenses incurred by the
       collaboration with Roche on ITMN-191.  The balance of 2009 R&D expense
       is related to the advancement of a named pirfenidone analog compound,
       ITMN-520, 
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SOURCE  InterMune, Inc.
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