7:32AM InterMune sees Q4 revs above estimates; sees FY14 revs in-line with consensus (ITMN) 15.13 : Co issues upside guidance for Q4 (Dec), sees Q4 (Dec) revs of $25.6 mln vs. $22.74 mln Capital IQ Consensus Estimate. Co issues in-line guidance for FY14 (Dec), sees FY14 (Dec) revs of $115-135 mln vs. $132.36 mln Capital IQ Consensus Estimate.
2013 Highlights:
Unaudited Esbriet revenue in the fourth quarter of 2013 totaled ~$25.6 mln, compared with $8.2 mln in the fourth quarter of 2012, an increase of 212 percent. Unaudited Esbriet revenue totaled ~$70.2 mln for the full-year 2013, compared with $26.2 mln in 2012, an increase of 168 percent.
Guidance for 2013 Operating Expenses
The company refined its financial guidance for 2013 operating expenses:
R&D expense: currently anticipated to be in the range of $110-115 mln versus the previous guidance range of $100-120 mln.
SG&A expense: currently anticipated to be in the range of $145-150 mln versus the previous guidance range of $145-165 mln.
Total Operating Expenses (R&D and SG&A): currently anticipated to be in the range of $255-265 mln compared to the previous guidance range of $245-285 mln.
2014 Outlook and Milestones
Esbriet in Europe
The company expects to continue its growth of Esbriet revenue in the 13 of 15 targeted countries in which Esbriet has now been launched.
InterMune expects to have further information on the status of pricing and reimbursement of Esbriet in Spain and the Netherlands in the first half of 2014.
In late 2014, the company expects to begin commercializing Esbriet in other countries beyond its initial EU priority 15 countries.
ASCEND and U.S. Pre-Launch Preparations
InterMune currently expects to report top-line results from ASCEND early in the second quarter of 2014 and to present study results at the May 2014 International Conference of the American Thoracic Society (ATS) in San Diego.
The company plans to provide a timeline for the Esbriet NDA resubmission when it announces the top-line results of ASCEND in the second quarter of 2014.
Guidance for 2014 Revenue and Operating Expenses
Esbriet revenue: currently projected to be in a range of $115-135 mln, compared-70.2 mln in 2013. The guidance range includes the recent decrease in the mandatory industry rebate in Germany from 16% to a maximum of 7% of gross revenues effective January 1, 2014.
The revenue guidance range includes potential Esbriet revenues from Spain and the Netherlands and potential revenues in late 2014 from other countries beyond the first-priority 15 EU countries.
InterMune expects to have additional clarity on the status of Esbriet reimbursement in Spain and the Netherlands during the first half of 2014.
The revenue guidance also accounts for the projected time needed to address public reimbursement procedures in Canada before meaningful Esbriet revenues can be achieved in all provinces and territories in that country.
Total Operating Expenses (R&D and SG&A): currently anticipated to be in a range of $320-345 mln.
