InterMune Reports Preliminary Fourth Quarter 2013 Esbriet® (pirfenidone) Revenue and Recent Business Highlights

   InterMune Reports Preliminary Fourth Quarter 2013 Esbriet® (pirfenidone)
                    Revenue and Recent Business Highlights

- Q4'13 revenue of $25.6 million represents ninth consecutive quarter of
Esbriet growth -

- Last patient to complete treatment this month in Phase 3 ASCEND trial -

- Strong progress on antifibrotic R&D pipeline -

PR Newswire

BRISBANE, Calif., Jan. 9, 2014

BRISBANE, Calif., Jan. 9, 2014 /PRNewswire/ --InterMune, Inc. (NASDAQ: ITMN)
today announced unaudited revenue for the fourth quarter and year ended
December 31, 2013. The company also provided updated 2013 expense guidance,
highlighted recent progress in its commercial and other business activities
and provided forward-looking guidance for 2014 revenue and expenses. 

(Logo: http://photos.prnewswire.com/prnh/20120827/SF62570LOGO)

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said,
"2013 was a year of strong execution and growing momentum in every part of our
business. Revenue from our Esbriet product, marketed in certain European
countries and Canada for the treatment of patients with idiopathic pulmonary
fibrosis, or IPF, grew by 168 percent in 2013 to approximately $70.2 million,
and we expect Esbriet revenue growth to continue in 2014 by 65-90 percent to
$115-$135 million. We are proud to have reported four consecutive quarters of
revenue growth during 2013 and nine consecutive quarters of growth since
Esbriet was first launched. Our European operations are performing well and
we expect cash flows from our European sales to fully support our European
operations sometime in the latter half of 2014.

"Today, we announced that we expect to communicate top-line results from the
ASCEND study early in the second quarter of 2014, and to present the study
results at the American Thoracic Society (ATS) conference in May 2014," Mr.
Welch added. "As we closed out 2013, we announced our progress and planned
investments in our growing R&D pipeline that build on our commercial momentum
with Esbriet, leverage our expertise in IPF and fibrosis and move us toward
realizing our strategic vision of becoming a leader in specialty fibrotic
diseases."

2013 Highlights
InterMune noted the following achievements in 2013:

  oUnaudited Esbriet revenue in the fourth quarter of 2013 totaled
    approximately $25.6 million, compared with $8.2 million in the fourth
    quarter of 2012, an increase of 212 percent. Unaudited Esbriet revenue
    totaled approximately $70.2 million for the full-year 2013, compared with
    $26.2 million in 2012, an increase of 168 percent.
  oEsbriet is now reimbursed, attractively priced and launched in countries
    that comprise approximately 85 percent of the population in the company's
    15 priority countries in Europe.
  oIn January 2013, InterMune launched Esbriet in Canada, the world's ninth
    largest pharmaceutical market. Esbriet is now reimbursed by approximately
    90 percent of the private insurers in Canada, which cover approximately
    one third of all IPF patients in that country. InterMune currently
    expects that meaningful reimbursement from the public plans will begin to
    be secured in the second half of 2014 and the process to be concluded in
    mid-2015.
  oThe last patients will complete treatment later this month in ASCEND, the
    company's pivotal Phase 3 trial of pirfenidone to support marketing
    approval in the United States. A safety follow-up period on the last
    patients must be completed and typical industry procedures conducted to
    ensure data integrity for all 555 patients at 127 sites prior to reporting
    top-line results. Top-line results are expected to be reported early in
    the second quarter of 2014.
  oStudy conduct in ASCEND remains excellent with a level of patient
    retention in the study that exceeds 90 percent. More than 95 percent of
    eligible patients (those patients who remain on blinded pirfenidone or
    placebo therapy) who have completed the ASCEND study have decided to enter
    the open-label RECAP extension study. RECAP is a study in which all
    patients receive pirfenidone. RECAP also includes patients rolled over
    from the company's prior CAPACITY program which completed in late 2008 and
    enrolled 779 patients in two Phase 3 studies. RECAP provides valuable
    long-term safety data that further expands the already large safety
    database for pirfenidone in patients with IPF.
  oIn November of 2013, InterMune announced its new strategic growth plan
    that will guide the company's investments and business focus to achieve
    its vision of becoming a leader in specialty fibrotic diseases. The
    strategic growth plan calls for targeted investments that will enable the
    company to:

       oSuccessfully commercialize Esbriet for IPF in its focus countries;
       oExpand the knowledge and use of Esbriet by introducing new
         formulations, conducting additional clinical studies, exploring
         possible new indications and implementing patient registries; and
       oGrow beyond Esbriet and beyond IPF, by developing compounds from
         internal R&D efforts and external business development that treat
         specific fibrotic indications with significant unmet medical need.

  oAlso in November of 2013, InterMune announced significant progress in
    advancing the company's strategic growth plan including:

       oInitiation in the third quarter of the PANORAMA clinical trial to
         evaluate the safety and tolerability of N-acetylcysteine (NAC) when
         added to Esbriet in IPF patients;
       oInitiation in October of the LOTUSS clinical trial to evaluate the
         safety and tolerability of Esbriet in patients with systemic
         sclerosis-related interstitial lung disease (SSc-ILD). SSc-ILD is an
         orphan disease with a prevalence approximately as large as that of
         IPF and with no approved therapies. In November, pirfenidone was
         granted orphan drug status for the treatment of SSc-ILD in the United
         States;
       oDevelopment of an improved Esbriet formulation intended to enhance
         patient convenience and potentially lead to greater compliance and
         persistence;
       oAdvancement to IND preparation stage of a second-generation
         pirfenidone compound (pirfenidone analog) which has demonstrated, in
         animals, greater potency, improved pharmacokinetics and improved
         dosing schedule and for which an IND filing is currently planned in
         approximately one year;
       oAdvancement of an LPA-1 receptor program. LPA-1 is a bioactive lipid
         receptor that is implicated in fibrosis in numerous organ systems;
       oProgress in the company's research efforts aimed at the discovery and
         evaluation of new compounds representing various antifibrotic
         mechanisms that have been shown to address important aspects of
         fibrotic pathophysiology;
       oMore than a dozen scientific abstracts covering the company's growing
         antifibrotic research and development pipeline have been submitted
         for presentation at the American Thoracic Society (ATS) meeting in
         May 2014.

Esbriet Fourth Quarter and Full-Year 2013 Unaudited Net Sales
Unaudited Esbriet revenue for the fourth quarter of 2013 totaled approximately
$25.6 million, compared with $8.2 million in the fourth quarter of 2012, an
increase of 212 percent. Unaudited Esbriet revenue totaled approximately
$70.2 million for the full-year 2013, compared with $26.2 million in 2012, an
increase of 168 percent. Higher revenues in both the three and 12-month
periods of 2013 were driven by both increased penetration in countries in
which Esbriet was launched in late 2011 or 2012 as well as additional launches
of Esbriet in European countries and Canada during 2013.

Guidance for 2013 Operating Expenses
The company refined its financial guidance for 2013 operating expenses:

  oR&D expense: currently anticipated to be in the range of $110 to $115
    million versus the previous guidance range of $100 to $120 million.
  oSG&A expense: currently anticipated to be in the range of $145 to $150
    million versus the previous guidance range of $145 to $165 million.
  oTotal Operating Expenses (R&D and SG&A): currently anticipated to be in
    the range of $255 to $265 million compared to the previous guidance range
    of $245 to $285 million.

2014 Outlook and Milestones

  oEsbriet in Europe

       oThe company expects to continue its growth of Esbriet revenue in the
         13 of 15 targeted countries in which Esbriet has now been launched.
       oInterMune 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.
       oIn late 2014, the company expects to begin commercializing Esbriet in
         other countries beyond its initial EU priority 15 countries.
       oInterMune currently has 170 employees in Europe and expects to expand
         its European commercial infrastructure to between 190 and 220
         employees by the end of 2014 depending upon the need to support
         potential launches in Spain, the Netherlands and additional European
         countries beyond the initial first-priority 15 countries.

  oASCEND and U.S. Pre-Launch Preparations 

       oInterMune 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.
       oThe 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.
       oInterMune currently plans to expand its current U.S. commercial
         infrastructure in 2014 and to invest during the year in various
         pre-launch preparations for Esbriet. The majority of headcount
         additions are expected to occur in the second half of 2014 and are
         premised on certain key events such as the results of the ASCEND
         study, filing of the U.S. NDA resubmission and progress on regulatory
         milestones.

Guidance for 2014 Revenue and Operating Expenses
The company provided its forward-looking financial guidance for Esbriet
revenue and operating expenses in 2014. The revenue projections underscore
the strong momentum in Esbriet revenue growth. The operating expense guidance
reflects the investment the company is making to simultaneously fund the
continued growth of Esbriet revenue in the EU and Canada, build its U.S.
commercial infrastructure to prepare for the expected U.S. launch of Esbriet
and advance its growing antifibrotic R&D pipeline:

  oEsbriet revenue: currently projected to be in a range of $115 to $135
    million, compared to $70.2 million 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.
  oResearch and Development (R&D) expense: currently anticipated to be in a
    range of $110 to $120 million. The anticipated increase of approximately
    0-5 percent in R&D expense in 2014 when compared to 2013 is accounted for
    by a reduction in expense from the completion of the ASCEND trial in the
    second quarter of 2014 which is more than offset by several factors:
    increased expenses in 2014 related to the full-year effect on expenses of
    the RECAP study (during 2013, an increasing number of patients in the
    ASCEND study were enrolledinto the open-label RECAP study); expenses
    related to the expected preparation, submission and prosecution of the
    Esbriet NDA resubmission; and new investments in the company's advancing
    research, pre-clinical and clinical development programs focused on
    antifibrotic therapies as mentioned above.
  oSelling, General and Administrative (SG&A) expense: currently anticipated
    to be in a range of $210 to $225 million. The approximate 45-50 percent
    growth in SG&A expense in 2014 when compared to 2013 is anticipated to
    come from three areas in descending order of magnitude: infrastructure
    building and commercial pre-launch preparations for the expected launch of
    Esbriet in the United States in 2015; the full-year effect on 2014
    expenses of commercial organizations that were established in the summer
    of 2013 in Italy and the UK and additional infrastructure to support the
    marketing of Esbriet in European countries beyond the company's 15 initial
    targeted EU markets. Investments in the U.S. will be tied to certain key
    events such as the results of the ASCEND study, filing of the U.S. NDA
    resubmission and progress on regulatory milestones.
  oTotal Operating Expenses (R&D and SG&A): currently anticipated to be in a
    range of $320 to $345 million.

About ASCEND
ASCEND is a multinational, randomized, double-blind, placebo controlled Phase
3 trial of 555 patients designed to evaluate the safety and efficacy of
Esbriet^® (pirfenidone) in IPF patients with mild to moderate impairment in
lung function. Patients were 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 be presented
as a categorical measure of the proportion of patients with decrements of less
than 0% or greater than 10% at Week 52. 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
studies at Week 52.

The two key secondary endpoints are 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. The median baseline percent predicted FVC of
patients enrolled in ASCEND is 68% compared with 73% in CAPACITY.

About IPF
Idiopathic pulmonary fibrosis (IPF) is an irreversible, unpredictable and
ultimately fatal disease characterized by scarring (fibrosis) in the lungs,
hindering the ability to process oxygen. IPF inevitably leads to worsening
lung function and exercise tolerance, and shortness of breath. Every IPF
patient follows a different and unpredictable course and it is not possible to
predict if a patient will progress slowly or rapidly, or when the rate of
decline may change. Periods of transient clinical stability in IPF, should
they occur, inevitably give way to continued disease progression. 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. IPF
typically occurs in patients over the age of 45, and 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, irreversible,
unpredictable and ultimately 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. Esbriet^® is not approved for sale in the
United States but is currently in a Phase 3 clinical trial to support
regulatory registration 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 and its R&D pipeline, please visit
www.intermune.com.

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 InterMune's expectations regarding
continued growth of Esbriet revenue in 2014 and that cash flow from sales of
Esbriet in Europe will fully support its European operations sometime in the
latter half of 2014; InterMune's expectation regarding the results of the
ASCEND study, including the time of availability and announcement of top-line
data from the study, and the prospects for success thereof; its anticipated
timing of concluding pricing and reimbursement discussions and/or initiating
commercial launches for Esbriet in various European countries, including the
Netherlands and Spain, and expectations regarding the potential for sales in
these countries to contribute to InterMune revenue; InterMune's expectations
regarding the timing of the reimbursement process in Canada; InterMune's
expectations regarding the advancement and timing of submission of an IND for
a second-generation pirfenidone compound; InterMune's expectations and belief
of growing beyond Esbriet and IPF; its expectations regarding the growth 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.; its projected operating expense for 2013;
and InterMune's projected revenue from sales of Esbriet and operating expenses
for 2014. 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 March 1, 2013 (the "Form 10-K"),
most recent quarterly report on Form 10-Q filed with the SEC on November 1,
2013 (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 new 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 Europe and Canada, including successfully
establishing a commercial operation in Europe and Canada and receiving
favorable governmental pricing and reimbursement approvals in the various
European countries 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 and Form 10-Q and
InterMune's other periodic reports filed with the SEC, all of which are
available via InterMune's web site at www.intermune.com.

Esbriet^® is a registered trademark of InterMune, Inc.

SOURCE InterMune, Inc.

Website: http://www.intermune.com
Contact: Jim Goff, InterMune, Inc., 415-466-2228, jgoff@intermune.com
 
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