) posted second-quarter loss per share of 78 cents, wider than the
year-ago loss of 70 cents and the Zacks Consensus Estimate of a
loss of 17 cents. Higher costs exacerbated the loss in the reported
InterMune reported revenues of $5.5 million in the second
quarter, up from year-ago revenues of $1.3 million. Notably,
revenues in the year-ago quarter only consisted of collaboration
revenues from the company's research agreement with
Roche Holdings Ltd.
), which completed in June 2011. Revenues, however, were well below
the Zacks Consensus Estimate of $40.0 million.
We remind investors that in June 2012 InterMune divested
Actimmune, which is approved for the treatment of chronic
granulomatous disease (CGD) and severe, malignant osteoporosis.
InterMune sold its rights to Actimmune to Vidara Therapeutics
International Limited for $55 million plus royalty payments over a
two-year period. InterMune expects royalty payments to be around
$2-$4 million over the period.
Esbriet (pirfenidone), which was launched in Germany in
September 2011, was the sole contributor to InterMune's total
revenues in the second 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 25.3% to $25.2 million. The increase in R&D
was due to the expenses associated with the ASCEND trial. The
ASCEND trial is supporting pirfenidone for the treatment IPF in the
United States. The company expects to complete enrollment in the US
and some other regions for the phase III study by this year. The
result of the ASCEND trial is expected in the first half of
Selling general and administrative (SG&A) expenses shot up
18.5% to $25.6 million. The increase was attributable to the costs
associated with the launch of Esbriet in Europe.
Apart from releasing the second quarter earnings results,
InterMune also provided guidance for Esbriet and operating expenses
The company expects Esbriet sales in 2012 in the range of
$20-$25 million. Management stated that while the lower end of the
guidance reflects no Esbriet launch in France, Spain and Italy this
year, the upper end of the projected range assumes Esbriet launch
in all these countries by the year end.
InterMune reaffirmed its operating expense guidance range for
2012 provided last month. The company continues to expect operating
expenses in the range of $200-$235 million for 2012. While R&D
expenses are expected in the range of $90-$105 million, SG&A
expenses are forecast in the range of $110-$130 million.
In March 2012, Germany's Federal Joint Committee (G-BA)
recognized the additional benefit of Esbriet. The company has
already negotiated the prices with the Statutory Health Insurance
which was expected to be done by September 15, 2012. The new price
represents a discount of 10% from the current price. The new price
will be effective from September 15, 2012.
During the second quarter of 2012, approximately 400 new
patients were prescribed Esbriet across Germany, compared with 300
new patients in the first quarter of 2012. InterMune believes that
around 750-800 patients are treated with Esbriet in Germany.
We currently have a Neutral recommendation on InterMune. The
stock carries a Zacks #3 Rank (short-term 'Hold' rating).
We believe Esbriet has significant commercial potential as it
targets IPF which is an orphan indication. Currently, there is no
FDA approved therapy for the treatment of IPF in the US. With the
EU approval of Esbriet, InterMune became the first company to offer
an IPF medicine in Europe. Though the sell of rights of Actimmune
will enable the company to pay more focus on Esbriet, pricing for
the latter remains a concern.
INTERMUNE INC (ITMN): Free Stock Analysis
(RHHBY): ETF Research Reports
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