InterMune Reports Fourth Quarter And Full Year 2012 Financial Results And Business Highlights

  InterMune Reports Fourth Quarter And Full Year 2012 Financial Results And
                             Business Highlights

PR Newswire

BRISBANE, Calif., Feb. 21, 2013

BRISBANE, Calif., Feb. 21, 2013 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN)
today announced results from operations for the fourth quarter and full year
ended December 31, 2012.

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

InterMune reported Esbriet^® (pirfenidone) net revenue in the fourth quarter
of 2012 of $8.2million, compared with $2.7 million in the fourth quarter of
2011. Esbriet is InterMune's product marketed in Europe for adults with
mild-to-moderate idiopathic pulmonary fibrosis (IPF), a chronic and ultimately
fatal disease of the lungs.

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said,
"We are very pleased with our solid progress in 2012, including five
consecutive quarters of Esbriet sales growth since its first European launch
in September of 2011. At year-end 2012, Esbriet was priced and launched in
nine of our 15 targeted European countries including the two largest EU
markets, Germany and France.

"In 2013, we expect continued progress in completing pricing and reimbursement
processes and additional Esbriet launches in Europe," Mr. Welch continued.
"We also expect to begin building our Esbriet franchise in North America after
launching Esbriet in Canada in January of 2013. Having completed in January
the full enrollment of the ASCEND Phase 3 study of pirfenidone intended to
support U.S. marketing approval, we are much closer to our goal of bringing
Esbriet to IPF patients in the United States, who currently have no approved
treatment options."

Fourth Quarter and Recent Highlights

  oOn October 1, 2012, Esbriet was approved in Canada for the treatment of
    mild to moderate IPF in adult patients and became commercially available
    on January 2, 2013. IPF affects approximately 5,000 to 8,000 Canadians.
    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 for all 10 provincial
    governments that reimburse the majority of medicines in Canada. 
  oAt the end of 2012, InterMune had concluded successful pricing and
    reimbursement discussions in nine European countries: Austria, Belgium,
    Denmark, France, Germany, Iceland, Luxembourg, Norway and Sweden.
  oInterMune today reiterated its current expectations regarding the on-going
    pricing and reimbursement processes for Esbriet in other European
    countries, processes over which InterMune has no control:

       oThe UK – The appraisal by the National Institute for Health and
         Clinical Excellence (NICE) is expected to be completed in March of
         2013. If NICE provides a positive appraisal for Esbriet and the
         pricing and reimbursement conditions are acceptable, the company
         expects to launch Esbriet as soon as possible thereafter.
       oItaly – The company continues to expect to conclude the pricing and
         reimbursement process in the first quarter of 2013 and to launch
         Esbriet in Italy as soon as possible after the process is
         successfully concluded, assuming that acceptable pricing and
         reimbursement conditions are negotiated. In Italy, up to three
         quarters are needed after national pricing and reimbursement is
         secured to address all regional reimbursement procedures before
         complete patient access to Esbriet is achieved. 
       oSpain – InterMune currently expects to conclude pricing and
         reimbursement of Esbriet in Spain by mid-2013 and to launch as soon
         as possible after pricing and reimbursement is concluded, assuming
         that acceptable pricing and reimbursement conditions are negotiated.
         In Spain, up to four quarters are needed after national
         reimbursement is secured to address all regional reimbursement
         procedures before complete patient access to Esbriet is achieved.
       oMid-Sized Countries (MSC) – In addition to the seven MSC for which
         Esbriet pricing has been secured, the company anticipates launches in
         the remaining three MSC of Netherlands, Finland and Ireland by
         mid-2013, assuming that acceptable pricing and reimbursement
         conditions are negotiated in these countries.

  oEnrollment of InterMune's Phase 3 pirfenidone study, ASCEND, in the United
    States and certain additional territories was completed in January 2013.
    ASCEND is a double-blind, placebo-controlled trial of 52 weeks duration
    with a primary endpoint of change in forced vital capacity (FVC) between
    baseline and Week 52. The trial enrolled IPF patients with
    mild-to-moderate impairment in lung function and certain characteristics
    that the company believes enhance the probability of a successful study
    outcome. Top-line results are expected in Q2 of 2014.
  oOn January 22, 2013, InterMune completed a public offering of 15,525,000
    shares of its common stock, including the underwriters' over-allotment,
    with net proceeds to the company of $145.7 million (after payment of
    underwriting discounts and commissions, and expenses). InterMune also
    completed a concurrent public offering of $120.75 million aggregate
    principal amount of the company's 2.50% convertible Senior Notes due 2017,
    including the Note underwriters' over-allotment, with net proceeds to the
    company of $116.7 million (after payment of the underwriting discounts and
    commissions, and expenses). The company has used proceeds from the
    convertible notes offering to repurchase and cancel $66.6 million of its
    outstanding $85.0 million aggregate principal amount 2015 Notes, and
    intends to repurchase the remaining $18.4 million of the outstanding 2015
    Notes over time. 
  oOn February 14, 2013 InterMune announced that Sean P. Nolan has joined the
    company as Executive Vice President and Chief Business Officer. Mr. Nolan
    will lead the creation and establishment of InterMune's U.S. Commercial,
    Business Development and Global Marketing groups. He will also oversee
    InterMune's Canadian business and the company's manufacturing and supply
    chain operations.
  oOn February 19, InterMune reported that the company and Shionogi & Co.,
    Ltd had reached an agreement regarding the material terms of a settlement
    of the complaint filed by Shionogi against InterMune. Effective January
    1, 2013, InterMune agrees to pay Shionogi a royalty of 4.25% on net sales
    of Esbriet in the European Union through the remaining period of Orphan
    Drug exclusivity ending in February 2021. Shionogi waives any claim
    against InterMune to royalties on European sales of Esbriet prior to
    January 1, 2013 and any claim to royalties on Esbriet sales in Canada or
    in the United States. The previous agreement provided for a royalty
    structure on net sales of pirfenidone equal to 6% of net sales for the
    first and second calendar year following commercialization, 8% of net
    sales for the third and fourth calendar year following commercialization
    and 10% of net sales for each subsequent calendar year thereafter.

Fourth Quarter and Full Year 2012 Financial Results (Unaudited)
InterMune reported total revenue in the fourth quarter of 2012 of $8.2
million, compared with $2.7 million in the fourth quarter of 2011, an increase
of 204 percent. Fourth quarter 2012 results included the effect of the
approximate 11 percent German price decrease of Esbriet, which became
effective on September 15, 2012. InterMune reported total revenue for the
full year 2012 of $26.2 million, compared with $5.4 million in 2011, an
increase of 385 percent. Total revenue in 2011 consisted of $2.8 million of
Esbriet revenue and $2.6 million of revenue from the company's research
collaboration with Roche, which was completed in June 2011.

Research and development (R&D) expenses in the fourth quarter of 2012 were
$32.0 million, compared with $21.0 million in the fourth quarter of 2011, an
increase of 52 percent. R&D expenses were $106.6 million for the full year
2012, compared with $75.0 million in 2011, an increase of 42 percent. Higher
R&D expenses in both the three- and 12-month periods of 2012, compared with
the same periods in 2011, primarily reflect expenses related to conduct of the
ASCEND trial, which was initiated in July 2011. 

Selling, general and administrative (SG&A) expenses were $29.6 million in the
fourth quarter of 2012, compared with $26.8 million in the same quarter of
2011, an increase of 10 percent. SG&A expenses were $105.3 million in the
full year 2012, an increase of 18 percent from $89.5 million in 2011. The
increased spending for the 12 months of 2012, compared with 2011, is primarily
attributable to the creation of InterMune's European infrastructure and
investments in the launch and pre-launches of Esbriet in nine European
countries and Canada.

Net loss for the fourth quarter of 2012 was $58.6 million, or $0.90 per share,
compared with a net loss of $44.5 million, or $0.69 per share, in the same
quarter of 2011. Per share amounts in the fourth quarter included gains from
the role of Actimmune^® (interferon gamma-1b) in discontinued operations of
$0.01 per share and $0.04 per share in 2012 and 2011, respectively.

Net loss for the full year 2012 was $150.1 million, or $2.30 per share,
compared with a net loss of $154.8 million, or $2.58 per share, in 2011. Per
share amounts for the full year included gains from the role of Actimmune in
discontinued operations of $0.52 per share and $0.12 per share in 2012 and
2011, respectively.

As a result of the June 19, 2012 divestiture of Actimmune, historical
Actimmune revenue, cost of goods sold, operating costs, and tax impact are
reported in discontinued operations in this and future financial statements
and therefore do not appear in the comparisons above regarding on-going
operations.

As of December 31, 2012, InterMune had cash, cash equivalents and
available-for-sale securities of approximately $308.0 million. The year-end
2012 cash balances do not include net proceeds from InterMune's concurrent
offerings of common stock and convertible notes, which were completed in
January 2013.

Guidance for 2013 Revenue and Operating Expenses
The company reiterated 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 three to six quarters needed from the
    date of conclusion of an agreement on pricing and reimbursement to comply
    with 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
    million.
  oSG&A expense: currently anticipated to be in a range of $145 to $165
    million.
  oTotal Operating Expenses (R&D and SG&A): currently anticipated to be in a
    range of $245 to $285 million.

Conference Call and Webcast Details
InterMune will host a live webcast of a conference call today at 4:30 p.m. EST
to discuss business highlights and financial results for the fourth quarter
and full year 2012. Interested investors and others may participate in the
conference call by dialing 800-891-8257 (U.S.) or +1-212-271-4651
(international), conference ID# 21648922. A replay of the webcast and
teleconference will be available approximately three hours after the call.

To access the webcast, please log on to the company's website at
www.intermune.com at least 15 minutes prior to the start of the call to ensure
adequate time for any software downloads that may be required.

A telephonic replay will be available for 10 business days following the call
and can be accessed by dialing 800-633-8284 (U.S.) or +1 402-977-9140
(international), and entering conference ID# 21648922. The webcast will
remain available on the company's website until the next earnings call.

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
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 expectation regarding
its anticipated timing of concluding pricing and reimbursement discussions
and/or initiating commercial launches for Esbriet in various European
countries; the estimated size of the patient population in Canada suffering
from IPF and InterMune's expectations with respect to Canada of securing
coverage from private insurance plans and reimbursement from public
(provincial) drug reimbursement plans including the timing thereof;
InterMune's expectation regarding the results of the ASCEND study and the
prospects of success thereof and meeting the goal of bringing Esbriet to IPF
patients in the United States; InterMune's expectation in building its
Esbriet franchise in North America; InterMune's intent to repurchase the
remaining $18.4 million of the outstanding 2015 notes; and InterMune's
projected revenue from sales of Esbriet and operating expenses for 2013. 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 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, 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.

Financial tables follow:





InterMune, Inc.
PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
                                Three Months Ended      Twelve Months Ended
                                December                December
                                2012        2011        2012         2011
Revenue, net
 Esbriet                     $ 8,222     $ 2,660     $ 26,174     $ 2,778
 Collaboration revenue         -           0           -            2,629
 Total revenue, net           8,222       2,660       26,174       5,407
Costs and expenses:
 Cost of goods sold            2,716       1,021       8,916        1,406
 Research and development      32,018      21,006      106,571      74,973
 Selling, general and          29,615      26,802      105,295      89,463
administrative
 Total costs and expenses    64,349      48,829      220,782      165,842
Loss from operations            (56,127)    (46,169)    (194,608)    (160,435)
Interest income                 134         166         586          556
Interest expense                (2,454)     (2,254)     (8,927)      (6,408)
Other income (expense)          (224)       (336)       (373)        (658)
Loss from operations before     (58,671)    (48,593)    (203,322)    (166,945)
income taxes
Income tax expense (benefit)    626         (1,579)     (19,230)     (4,760)
Loss from continuing            (59,297)    (47,014)    (184,092)    (162,185)
operations
Income (loss) from
discontinued operations, net    733         2,481       34,011       7,411
of taxes
Net loss                      $ (58,564)  $ (44,533)  $ (150,081)  $ (154,774)
Basic and diluted net income
(loss) per common share:
 Continuing operations        (0.91)      (0.73)      (2.82)       (2.70)
 Discontinued operations      0.01        0.04        0.52         0.12
                              $ (0.90)    $ (0.69)    $ (2.30)     $ (2.58)
Shares used in computing
basic and diluted net loss      65,404      64,572      65,184       60,100
per share





InterMune, Inc.
PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
                                                      December    December 31,
                                                      2012        2011
Cash, cash equivalents and available-for-sale       $ 307,986   $ 425,110
securities
Acquired product rights, net                          18,250      19,250
Other assets                                          37,230      28,263
 Total assets                                      $ 363,466   $ 472,623
Total other liabilities                             $ 56,899    $ 34,205
Convertible notes                                     240,250     240,250
Stockholders' equity                                  66,317      198,168
 Total liabilities and stockholders' equity        $ 363,466   $ 472,623

SOURCE InterMune, Inc.

Website: http://www.intermune.com
Contact: Jim Goff, InterMune, Inc., +1-415-466-2228, jgoff@intermune.com