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

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

- Reports Full Enrollment of Phase 3 ASCEND Trial -

- Provides 2013 Revenue Guidance for Esbriet® -

PR Newswire

BRISBANE, Calif., Jan. 3, 2013

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.


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 toshow consistent growth andbecome 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:

  oEsbriet 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.
  oStrong pricing and reimbursement progress was made in the remaining six
    targeted European countries.
  oThe Esbriet launch in Germany is among the Top 5 most successful orphan
    drug launches in that country.
  oFull-year 2012 Esbriet revenues were above the high end of the Company's
    revenue guidance.
  oEsbriet is now approved and launched in Canada – the world's ninth largest
    pharmaceutical market.
  oEnrollment 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:

  oR&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.
  oSG&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.
  oTotal 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:

European Launch of Esbriet

The Company has launched Esbriet in nine of its Top 15 targeted European
countries and anticipates that in 2013, Esbriet will be marketed in all 15 of
its targeted EU markets, assuming acceptable pricing and reimbursement for
Esbriet is negotiated in each remaining country:

  oThe Company currently expects to conclude pricing and reimbursement
    discussions regarding Esbriet in Italy in Q1 2013 and Spain by mid-2013
    and to launch Esbriet in those countries as soon as possible after pricing
    and reimbursement is concluded.In both of these countries, several
    quarters are needed after national reimbursement is secured to address
    regional reimbursement procedures before complete patient access to
    Esbriet is achieved. 
  oThe review of Esbriet by the National Institute for Clinical Excellence
    (NICE) in the UK is expected to conclude in March 2013. In November of
    2012, the preliminary assessment of Esbriet completed by NICE was
    unsupportive of Esbriet reimbursement and the Company is in the process of
    addressing various outstanding issues in the NICE preliminary assessment.
    If NICE decides in March to support the reimbursement of Esbriet, the
    Company currently expects to launch the product as soon as possible with a
    target to complete the launch in the second quarter of 2013. 
  oThe Company anticipates launches of Esbriet by mid-2013 in several
    so-called mid-sized countries – Belgium, Netherlands, Finland and
    Ireland. The first of these, Belgium, began its full launch on January
  oInterMune currently has 118 employees in Europe and plans to expand its
    European commercial infrastructure to support expected launches in the
    remaining six targeted European countries.The Company currently expects
    to have between 200 and 220 employees in Europe by the end of 2013,
    assuming that all country launches of Esbriet occur as currently planned
    and the company expands its distribution beyond the Top 15 countries.

North America: ASCEND, U.S. Pre-Launch Preparations and Canadian Launch

InterMune today announced that the full-enrollment target of 500 randomized
patients for ASCEND was achieved in December 2012.ASCEND is the Company's
Phase 3 clinical trial to further evaluate pirfenidone as a treatment for
patients with idiopathic pulmonary fibrosis (IPF), and to support regulatory
approval in the United States.InterMune noted there has been strong interest
from investigators and a large number of patients entered screening in the
last two months; these patients will be allowed to continue the screening
process in ASCEND and the last patient is expected to be randomized on or
before January 9, 2013.The ASCEND trial design includes a 52-week treatment
period, followed by a five-week safety follow-up. Top-line results from ASCEND
currently are expected in the second quarter of 2014. (See "About ASCEND"
section for details of the study)

In 2013, InterMune currently plans to begin building its U.S. commercial
infrastructure and begin pre-launch preparations for Esbriet.

The Company announced today that it began the launch of Esbriet in Canada on
January 2. As communicated earlier, up to six months are needed to secure
coverage for new medicines from the major private insurance companies in
Canada and, on average, about 18 months are needed to secure reimbursement
from all ten provincial governments that reimburse the majority of medicines
in Canada. 

Guidance for 2013 Revenue and Operating Expenses

The Company provided its forward-looking financial guidance for Esbriet
revenue and operating expenses in 2013:

  oEsbriet revenue: currently projected to be in a range of $40 to $70
    million.This includes projected revenue in a range of $40 to $55 million
    in countries where Esbriet is currently launched (Germany, France, Canada
    and seven mid-sized European countries), and projected revenue in a range
    of $0 to $15 million in countries where Esbriet pricing and reimbursement
    approval and launch is not yet concluded but is currently anticipated
    during 2013 (Italy, UK, Spain and three mid-sized European countries).The
    guidance also accounts for the projected time needed to address regional
    and provincial reimbursement procedures in Italy, Spain and Canada before
    meaningful Esbriet revenues can be achieved in all regions or provinces in
    these countries.
  oR&D expense: currently anticipated to be in a range of $100 to $120
  oSG&A expense: currently anticipated to be in a range of $145 to $165
  oTotal Operating Expenses (R&D and SG&A): currently anticipated to be in a
    range of $245 to $285 million.


ASCEND is a multinational, randomized, double-blind, placebo controlled Phase
3 trial designed to evaluate the safety and efficacy of Esbriet® (pirfenidone)
in IPF patients with mild to moderate impairment in lung function. Patients 
are randomly assigned 1:1 to receive oral pirfenidone (2403 mg/day) or
placebo.The primary endpoint is change in percent predicted forced vital
capacity (FVC), with the primary outcome analysis a Rank ANCOVA at Week
52.The magnitude of effect will also be presented on a categorical basis as
the proportion of patients with decrements of less than 0% or greater than 10%
at pre-specified study time points. The study was conservatively powered by
estimating the treatment effect size of pirfenidone based on the results of
the intent-to-treat analysis of the pooled results of the two CAPACITY Phase 3

Key secondary endpoints include change in six-minute walk test (6MWT) distance
and progression-free survival, which will be based on the earliest of time to
death, FVC decrement of 10% or greater, or decrement in 6MWT distance of 50
meters or more. Additional secondary endpoints in ASCEND include all-cause
mortality and on-treatment IPF-related deaths (both evaluated independently in
ASCEND as well as pooled with the previous CAPACITY data), and dyspnea. Based
on the relatively low mortality rate in this patient population, ASCEND is not
powered for the mortality endpoint, even after pooling with CAPACITY data.

Relative to InterMune's two previous studies of pirfenidone in IPF (CAPACITY),
the entry criteria for ASCEND were refined to enrich the study population for
patients who are more likely to experience decline in lung function and
disease progression during the study.This included modest changes to the
eligibility criteria for FVC, DLco, FEV1/FVC ratio, and time since
diagnosis.These changes increase the likelihood of demonstrating significant
findings on multiple endpoints in ASCEND.

About Esbriet® (pirfenidone)

Esbriet is an orally active drug that inhibits the synthesis of TGF-beta, a
chemical mediator that controls many cell functions including proliferation
and differentiation, and plays a key role in fibrosis, or scarring, of the
lung.It also inhibits the synthesis of TNF-alpha, a cytokine that is known to
have an active role in inflammation.

Pirfenidone is the first and only medicine approved anywhere in the world for
the treatment of IPF. Pirfenidone is approved in 29 European countries under
the InterMune trade name Esbriet and in Japan and South Korea where it is
marketed by Shionogi & Co. Ltd under the trade name Pirespa®. Under different
trade names, pirfenidone is also approved for the treatment of IPF in China,
India, and Argentina.

About IPF

Idiopathic pulmonary fibrosis (IPF) is a progressive, debilitating and
ultimately fatal disease characterized predominantly by fibrosis (scarring) in
the lungs, hindering the ability for gas exchange in the lungs. IPF is a
progressive disease, meaning that over time, lung scarring and symptoms
increase in severity.The median survival time from diagnosis is two to five
years, with a five-year survival rate of approximately 20-40 percent, which
makes IPF more rapidly lethal than many malignancies, including breast,
ovarian and colorectal cancers.Patients diagnosed with IPF are primarily
between the ages of 40 and 80, with a median age of 63 years.The disease
tends to affect slightly more men than women.

About InterMune

InterMune is a biotechnology company focused on the research, development and
commercialization of innovative therapies in pulmonology and orphan fibrotic
diseases. In pulmonology, the Company is focused on therapies for the
treatment of idiopathic pulmonary fibrosis (IPF), a progressive and fatal lung
disease. Pirfenidone, the only medicine approved for IPF anywhere in the
world, is approved for marketing by InterMune in the EU and Canada as Esbriet®
and is currently in a Phase 3 clinical trial to support regulatory approval in
the United States. InterMune's research programs are focused on the discovery
of targeted, small-molecule therapeutics and biomarkers to treat and monitor
serious pulmonary and fibrotic diseases.For additional information about
InterMune, please visit

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of
section 21E of the Securities Exchange Act of 1934, as amended, that reflect
InterMune's judgment and involve risks and uncertainties as of the date of
this release, including without limitation the statements regarding
InterMune's expectations that Esbriet will show consistent growth and become a
very meaningful brand in Europe and Canada in the coming years; its
anticipated full-year 2012 operating expenses; its anticipated timing of
concluding pricing and reimbursement discussions and/or initiating commercial
launches for Esbriet in various European countries; its expectations regarding
the size of its European commercial infrastructure; InterMune's expectations
regarding the timing of building its U.S. commercial infrastructure and
preparations for a pre-launch of Esbriet in the U.S.; InterMune's projected
revenue from sales of Esbriet and operating expenses for 2013; and its
expectation regarding the timing and nature of enrollment in, and results of,
the ASCEND study and the prospects of success thereof. All forward-looking
statements and other information included in this press release are based on
information available to InterMune as of the date hereof, and InterMune
assumes no obligation to update any such forward-looking statements or
information. InterMune's actual results could differ materially from those
described in InterMune's forward-looking statements.

Other factors that could cause or contribute to such differences include, but
are not limited to, those discussed in detail under the heading "Risk Factors"
in InterMune's most recent annual report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on February 29, 2012 (the "Form
10-K"), most recent quarterly report on Form 10-Q filed with the SEC on
November 9, 2012 (the "Form 10-Q") and other periodic reports filed with the
SEC, including but not limited to the following: (i) the risks related to the
uncertain, lengthy and expensive clinical development process for the
Company's product candidates, including having no unexpected safety,
toxicology, clinical or other issues and having no unexpected clinical trial
results such as unexpected new clinical data and unexpected additional
analysis of existing clinical data; (ii) risks related to the regulatory
process for the Company's product candidates, including the possibility that
the results of the 52-week Phase 3 clinical trial (ASCEND) having an FVC
endpoint may not be satisfactory to the FDA for InterMune to receive
regulatory approval for pirfenidone in the United States; (iii) risks related
to unexpected regulatory actions or delays or government regulation generally;
(iv) risks related to the Company's manufacturing strategy, which relies on
third-party manufacturers and which exposes InterMune to additional risks
where it may lose potential revenue; (v) government, industry and general
public pricing pressures; (vi) risks related to our ability to successfully
launch and commercialize Esbriet in the EU and Canada, including successfully
establishing a commercial operation in the EU and Canada and receiving
favorable governmental pricing and reimbursement approvals in each EU country
and securing coverage from private insurance plans and reimbursement from
public (provincial) drug reimbursement plans in Canada; and (vii) InterMune's
ability to obtain or maintain patent or other proprietary intellectual
property protections. The risks and other factors discussed above should be
considered only in connection with the fully discussed risks and other factors
discussed in detail in the Form 10-K, Form 10-Q and InterMune's other periodic
reports filed with the SEC, all of which are available via InterMune's web
site at 

SOURCE InterMune, Inc.

Contact: Jim Goff, InterMune, Inc., +1-415-466-2228,
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