InterMune Reports Preliminary Fourth Quarter 2012 Esbriet® (pirfenidone) Revenue And Other Recent Business Highlights

BRISBANE, Calif., Jan. 3, 2013 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN) today announced unaudited net sales of Esbriet® (pirfenidone) for the fourth quarter ended December 31, 2012. The Company also highlighted recent business and clinical development activities, including completion of enrollment in the Phase 3 ASCEND trial, and provided forward-looking revenue and expense guidance for 2013. 

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Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "We are very pleased with our progress in 2012. Our product Esbriet for the treatment of patients with IPF is now commercially available in nine of our targeted 15 European countries and as of yesterday, in Canada. 

"Esbriet revenues increased by 9 percent to approximately $8.2 million in the fourth quarter from $7.5 million in the third quarter of 2012," Mr. Welch continued. "As explained on our Third Quarter 2012 earnings call, third quarter Esbriet revenue of $7.5 million included approximately $0.5 million of favorable accounting adjustments. Fourth quarter revenue reflected a full quarter of the expected 11 percent price decrease in Germany. Taking into account these two factors, the underlying quarterly growth in Esbriet sales was significantly stronger than 9 percent."

Mr. Welch continued, "The forward-looking revenue guidance we are providing today indicates that we expect Esbriet to show consistent growth and become a very meaningful brand in Europe and Canada in the coming years. With today's announcement regarding the completion of patient enrollment in the ASCEND trial to support regulatory approval in the United States, we are closing in on the attractive U.S. market and are now preparing for the U.S. launch of Esbriet, subject to a favorable outcome of ASCEND and FDA approval."

2012 Highlights

InterMune noted the following achievements in 2012:

• Esbriet is now attractively priced and launched in nine of the Company's 15 targeted European countries including the two largest EU markets, Germany and France.
• Strong pricing and reimbursement progress was made in the remaining six targeted European countries.
• The Esbriet launch in Germany is among the Top 5 most successful orphan drug launches in that country.
• Full-year 2012 Esbriet revenues were above the high end of the Company's revenue guidance.
• Esbriet is now approved and launched in Canada – the world's ninth largest pharmaceutical market.
• Enrollment was completed for the Company's pivotal Phase 3 trial – "ASCEND" for the U.S. market.

Esbriet Fourth Quarter and Full Year Unaudited Net Sales 

Unaudited net sales of Esbriet during the fourth quarter of 2012 totaled approximately $8.2 million.  Unaudited net sales of Esbriet totaled approximately $26.1 million for the full-year of 2012, consistent with the Company's guidance on its Third Quarter 2012 earnings call of revenue being at or slightly above the high end of a range of $20-$25 million. Fourth quarter 2012 revenue includes the impact of a full quarter's effect of the approximate 11 percent expected price decrease of Esbriet in Germany, which became effective on September 15, 2012. 

Guidance for 2012 Operating Expenses

The Company updated its financial guidance for 2012 operating expenses:

• R&D Expense: anticipated to be in a range of approximately $100 to $105 million; previously estimated during InterMune's Third Quarter 2012 earnings call to be at the high end of the range of $90 to $105 million.
• SG&A Expense: anticipated to be in a range of approximately $105 to $110 million; previously estimated during InterMune's Third Quarter 2012 earnings call to be at the low end of the range of $110 to $130 million. 
• Total Operating Expenses (R&D and SG&A): anticipated to be in a range of approximately $205 to $215 million; compared to the previously projected range announced during InterMune's Third Quarter 2012 earnings call of $200 to $235 million.

2013 Milestones  

InterMune provided the following information with respect to anticipated milestones and events in 2013:

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