) third-quarter adjusted loss per share of 62 cents was a penny
narrower than the year-ago loss. The third-quarter loss was also
narrower than the Zacks Consensus Estimate of a loss of 71 cents.
The narrower loss was due to higher revenues, partially mitigated
by higher expenses.
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InterMune reported revenues of $19.7 million in the third quarter
of 2013, compared with year-ago revenues of $7.5 million.
Revenues also increased 37% on a sequential basis.
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 also above the Zacks Consensus
Estimate of $16 million. The company expects fourth quarter 2013
revenues to surpass the third quarter figure.
Esbriet was the sole contributor to InterMune's revenues in the
third quarter of 2013. Esbriet is approved for the treatment of
idiopathic pulmonary fibrosis (IPF), a fatal lung disease.
During the quarter, research and development (R&D) expenses
increased 4.4% to $27.3 million. The increase in R&D was due
to expenses associated with the ASCEND trial and also the RECAP
open-label extension study.
The ASCEND trial will support the filing of Esbriet for the
treatment of IPF in the U.S. In Jan 2013, the company completed
enrollment for the phase III study in the U.S. InterMune
confirmed in its press release that top-line results from the
ASCEND trial are expected in the second quarter of 2014.
Selling general and administrative (SG&A) expenses were up
48.3% to $35.2 million during the reported quarter. The increase
in SG&A expenses during the reported quarter was primarily
attributable to expenses related to pre-launch and subsequently
launch of Esbriet in the EU and Canada.
Apart from announcing its results, the company updated its
previously announced guidance for the year 2013. InterMune now
expects Esbriet sales in the range of $60−$70 million (previous:
$55−$70 million) in 2013. The Zacks Consensus Estimate for 2013
total revenues of $62 million is on the lower end of the guidance
The company expects 2013 operating expenses towards the lower end
of its previous guidance range of $245-$285 million. InterMune
expects 2013 R&D expenses in the middle of its previous
guidance range of $100-$120 million. Meanwhile, 2013 SG&A
expenses are expected towards the lower end of the company's
previous guidance range of $145-$165 million.
To date, Esbriet has been successfully launched in 13 European
countries, namely, Austria, Belgium, Denmark, France, Germany,
Iceland, Luxembourg, Norway, Sweden, Finland, Italy, England and
Ireland. The company expects to provide an update on pricing and
reimbursement discussions in Spain and the Netherlands by the
first half of next year.
Though Esbriet is the only approved medicine for IPF, companies
) are developing therapies to treat IPF. We remain concerned
about the fact that InterMune is dependent on a single product
for growth. We expect investor focus to remain on the pricing and
reimbursement in the remaining EU countries.
InterMune presently carries a Zacks Rank #2 (Buy). Stocks such as
) currently look more attractive with a Zacks Rank #1 (Strong