) fourth-quarter loss per share of 91 cents was wider than the
Zacks Consensus Estimate of a loss of 86 cents and the year-ago
loss of 73 cents per share. The wider loss during the quarter was
primarily due to higher operating expenses.
InterMune reported a loss of $2.82 per share for full year
2012, wider than the year-ago loss of $2.70 per share. Loss for
the year was also wider than the Zacks Consensus Estimate of a
loss of $2.35 per share. For the full year 2012, the company
recorded total revenues of $26.2 million compared with the
year-ago figure of $5.4 million. Revenues however, fell short of
the Zacks Consensus Estimate of $29 million.
InterMune reported revenues of $8.2 million in the fourth
quarter of 2012, compared with the year-ago revenues of $2.7
million. The sharp increase in total revenues was primarily due
to a boost in Esbriet (pirfenidone) sales. The drug was launched
in Germany in Sep 2011. Revenues were just above the Zacks
Consensus Estimate of $8 million.
Esbriet was the sole contributor to InterMune's total revenues
in the fourth quarter of 2012. Esbriet is approved for the
treatment of idiopathic pulmonary fibrosis (IPF), a fatal lung
During the reported quarter, research and development
(R&D) expenses increased 52.4% to $32.0 million. The increase
in R&D was due to the expenses associated with the ASCEND
The ASCEND trial is supporting pirfenidone for the treatment
of IPF in the US. In Jan 2013, the company completed enrollment
for the phase III study in the US and some additional
territories. Result from the ASCEND trial are expected in the
second quarter of 2014.
Selling general and administrative (SG&A) expenses were up
10% to $29.6 million during the reported quarter. The increase in
SG&A expenses during the reported quarter was primarily due
to expenses related to the launch and pre-launch of Esbriet in
Apart from announcing its results, the company also maintained
its previously announced guidance for the year 2013. InterMune
expects Esbriet sales of $40-$70 million in 2013. The guidance
includes $40-$55 million from countries where the product is
currently launched and the rest from the countries where the drug
is yet to be launched. Total revenues for 2013 as per the Zacks
Consensus Estimate are $61 million.
InterMune's total operating expense guidance for 2013 is in
the range of $245-$285 million including R&D expense guidance
of $100-$120 million and SG&A expense guidance of $145-$165
In Oct 2012, Esbriet was approved in Canada for the treatment
of adults suffering from IPF. Canada is the ninth largest
pharmaceutical market in the world.
As of 2012, Esbriet is successfully priced and launched in
nine European countries, namely Austria, Belgium, Denmark,
France, Germany, Iceland, Luxembourg, Norway and Sweden.
InterMune is working on the pricing and reimbursement process
in the remaining EU countries. The company expects to complete
pricing and reimbursement in the UK, Italy, Spain and other
mid-sized countries by mid-2013. The company expects to launch
Esbriet in six more EU countries by mid-year.
We remind investors that in Feb 2013, InterMune entered into
an agreement with Shionogi & Co., Ltd regarding the terms of
a settlement of the complaint filed by Shionogi against
InterMune. As per the terms of the agreement, InterMune will pay
a royalty of 4.25% on net sales of Esbriet in the EU effective
from Jan 1, 2013. The royalty will be paid throughout the drugs
orphan drug exclusivity in the EU which expires in 2021.
Though Esbriet is the only approved medicine for IPF,
) are developing candidates for IPF. We remain concerned about
the fact that InterMune is dependent on a single product for
growth. Meanwhile, we expect investor focus to remain on the
pricing and reimbursement in the remaining EU countries.
InterMune carries a Zacks Rank #3 (Hold). Meanwhile, other
biotech stocks such as
) carry a Zacks Rank #2 (Buy).
AGENUS INC (AGEN): Free Stock Analysis Report
INTERMUNE INC (ITMN): Free Stock Analysis
NOVARTIS AG-ADR (NVS): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
To read this article on Zacks.com click here.