InterMune Reports Third Quarter 2012 Financial Results And Business Highlights

InterMune Reports Third Quarter 2012 Financial Results And Business Highlights

PR Newswire

BRISBANE, Calif., Nov. 7, 2012

BRISBANE, Calif., Nov. 7, 2012 /PRNewswire/ -- InterMune, Inc. (NASDAQ: ITMN)
today announced results from operations for the third quarter and nine months
ended September 30, 2012. 

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

InterMune reported Esbriet^® (pirfenidone) net revenue in the third quarter of
2012 of $7.5 million, approximately 91 percent of which was from Germany,
which was the first country in which Esbriet was launched in September 2011.
Esbriet revenue was $0.1 million in the third quarter of 2011 which reflected
less than one month's revenue of Esbriet from Germany. 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 arepleased to report this quarter many important accomplishments by our
European and Canadian businesses and continued sequential quarterly growth in
Esbriet sales since its first launch in Europe in September of 2011." 

Mr. Welch continued, "With continued successful completion of the pricing and
reimbursement processes and Esbriet launches throughout Europe over the coming
months, along with the planned launch of Esbriet in Canada on January 1, 2013,
we have begun a period of sustained annual sales growth. We also expect that
our ASCEND Phase 3 study, which is nearing full enrollment, will lead to
positive top-line data in the first half of 2014 and the launch of Esbriet in
the U.S., providing further acceleration of our sales growth."

Esbriet^® (pirfenidone) Third Quarter Accomplishments and Recent Highlights

  oOn September 11, 2012, InterMune announced that the final procedural step
    for French pricing and reimbursement of Esbriet had been completed. The
    company expects the commercial launch of Esbriet in France in the second
    half of November 2012.
  oOn October 2, 2012, InterMune announced that Health Canada had approved
    Esbriet for the treatment of mild to moderate IPF in adult patients. IPF
    affects approximately 5,000 to 8,000 Canadians. InterMune expects to make
    Esbriet available in Canada starting January 1, 2013 with a commercial
    organization of approximately 18 to 20 in Canada at the time of launch,
    including a field force of 10. Approximately one-third of IPF patients in
    Canada are covered by private insurance and InterMune expects to secure
    coverage from substantially all of the private insurance plans in the
    first half of 2013. Public (provincial) drug reimbursement plans cover
    approximately two-thirds of IPF patients and reimbursement from these
    plans is typically secured within 12 to 18 months of marketing approval.
    
  oInterMune today announced that the company secured Esbriet pricing and
    reimbursement in Belgium effective December 1, 2012 and plans to launch
    Esbriet there in early 2013. The Belgian annualized price of Esbriet is
    €30,240, or $36,533 at current exchange rates.
  oInterMune has now concluded successful pricing and reimbursement
    discussions in nine European countries: Austria, Belgium, Denmark, France,
    Germany, Iceland, Luxembourg, Norway and Sweden.
  oInterMune today provided an update on the on-going pricing and
    reimbursement processes for Esbriet in the various European countries:

       oItaly – The company announced today that Esbriet successfully passed
         the Italian Technical-Scientific Commission review in October. The
         company expects to conclude the pricing and reimbursement process in
         December of 2012 and plans to launch Esbriet in Italy as soon as
         possible after the process is successfully concluded and various
         authorizations are secured. 
       oSpain – Considering a Royal Decree introduced in 2012 affecting
         health care expenditures and pharmaceuticals, and the continuing
         economic challenges of the country, forecasting of the timing of
         pricing and reimbursement decisions has become more challenging for
         all manufacturers. As a result, InterMune currently believes that it
         is more likely that a decision regarding pricing and reimbursement of
         Esbriet in Spain will occur in the first half of 2013 than in the
         fourth quarter of this year. 
       oThe UK – InterMune today confirmed its previous guidance that 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, the company expects
         to launch Esbriet as soon as possible thereafter.
       oMid-Sized Countries (MSC) – In addition to the seven MSC for which
         Esbriet pricing has been secured, the company expects to conclude
         pricing and reimbursement processes in the remaining three MSC of
         Netherlands, Finland and Ireland in the first half of 2013 and launch
         as soon as possible thereafter, assuming that acceptable pricing and
         reimbursement conditions are negotiated in these countries.

  oInterMune confirmed its earlier guidance that it expects to have launched
    Esbriet in all top 5 markets and 10 mid-sized markets in Europe,
    comprising 75 percent of the EU population and 80-85 percent of the
    European pharmaceutical market, in the second quarter of 2013, assuming
    acceptable pricing and reimbursement is secured.
  oEnrollment of InterMune's Phase 3 pirfenidone study, ASCEND, in the United
    States and certain additional territories continues to proceed according
    to plans. The company expects the study to be fully enrolled around the
    end of 2012, and that results from the study will be available in the
    first half of 2014. 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 is planned to
    enroll approximately 500 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.

Third Quarter and First Nine Months 2012 Financial Results (Unaudited)
InterMune reported total revenue in the third quarter of 2012 of $7.5 million,
compared with $0.1 million in the third quarter of 2011. Third quarter 2012
revenue included $0.5 million of favorable adjustments to revenue primarily
related to favorable foreign exchange fluctuations. InterMune reported total
revenue for the first nine months of 2012 of $18.0 million, compared with $2.7
million in the first nine months of 2011. Revenue was almost entirely from
sales of Esbriet in Germany, as active promotion in the largest of the
mid-sized countries for which pricing and reimbursement is approved began in
September of 2012. Included in the third quarter 2012 results was the effect
of the approximate 11 percent German price decrease of Esbriet, which became
effective on September 15, 2012 as previously announced. Total revenue in the
first nine months of 2011 included $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 third quarter of 2012 were
$26.2 million, compared with $17.0 million in the third quarter of 2011, an
increase of 54 percent. R&D expenses were $74.6 million for the nine months
ended September 30, 2012, compared with $54.0 million in the same period of
2011, an increase of 38 percent. Higher R&D expenses in both the three- and
nine-month periods of 2012, compared with the same periods in 2011, reflect
expenses related to conduct of the ASCEND trial, which was initiated in July
2011. 

Selling, general and administrative (SG&A) expenses were $23.8 million in the
third quarter of 2012, relatively unchanged from $23.7 million in the same
quarter of 2011. SG&A expenses were $75.7 million in the first nine months of
2012, an increase of 21 percent from $62.7 million in the comparable
nine-month period of 2011. The increased spending for the nine-month period
in 2012, compared with the same period in 2011, is primarily attributable to
the creation of InterMune's European infrastructure and investments in the
launch and pre-launches of Esbriet in Germany and other European countries.

Net loss for the third quarter of 2012 was $45.4 million, or $0.70 per share,
compared with a net loss of $38.2 million, or $0.63 per share, in the same
quarter of 2011. Net loss for the first nine months of 2012 was $91.5
million, or $1.41 per share, compared with a net loss of $110.2 million, or
$1.88 per share, in the first nine months of 2011. Per share amounts in the
first nine months included gains from the role of Actimmune^® (interferon
gamma-1b) in discontinued operations of $0.82 per share and $0.14 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 and operating costs 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 September 30, 2012, InterMune had cash, cash equivalents and
available-for-sale securities of approximately $351.4 million.

Guidance for 2012 Revenue and Expenses
Considering the proximity to year-end 2012, the company today provided greater
precision regarding its forward-looking guidance for Esbriet revenue and
operating expense guidance for 2012:

  oEsbriet revenue: currently anticipated to be in a range of $20 to $25
    million. The company anticipates that full-year revenue will be at or
    slightly above the high end of the range.
  oR&D expense: currently anticipated to be in a range of $90 to $105
    million. The company anticipates that full-year R&D expenses will be at
    the high end of the range.
  oSG&A expense: currently anticipated to be in a range of $110 to $130
    million. The company anticipates that full-year SG&A expenses will be at
    the low end of the range. 
  oTotal Operating Expenses (R&D and SG&A): currently anticipated to be in a
    range of $200 to $235 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 thethird quarter and
first nine months of 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# 21610043. 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# 21610043. 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 our expectation regarding continued
growth of Esbriet revenues in Germany, other EU countries and Canada, our
anticipated timing of concluding pricing and reimbursement discussions and/or
initiating commercial launches for Esbriet in Canada, France, Italy, Spain,
the United Kingdom and other EU countries, the estimated size of the patient
population in Canada suffering from IPF and our expectations with respect to
Canada of securing coverage from private insurance plans and reimbursement
from public (provincial) drug reimbursement plans including the timing
thereof, our expectations regarding headcount in our Canadian commercial
organization and the functions of such personnel, and our expectation
regarding the timing and nature of full 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 August
8, 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 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 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     Nine Months Ended
                                 September 30,          September 30,
                                 2012        2011       2012         2011
Revenue, net
 Esbriet                      $ 7,534     $ 118      $ 17,952     $ 118
 Collaboration revenue          -           0          -            2,629
 Total revenue, net            7,534       118        17,952       2,747
Costs and expenses:
 Cost of goods sold             2,017       385        6,200        385
 Research and development       26,175      17,045     74,553       53,967
 Selling, general and           23,754      23,652     75,680       62,661
administrative
 Total costs and expenses     51,946      41,082     156,433      117,013
Loss from operations             (44,412)    (40,964)   (138,481)    (114,266)
Interest income                  148         131        452          390
Interest expense                 (2,031)     (1,281)    (6,473)      (4,154)
Other income (expense)           975         (227)      (149)        (322)
Loss from operations before      (45,320)    (42,341)   (144,651)    (118,352)
income taxes
Income tax expense               192         -          326          -
Loss from continuing             (45,512)    (42,341)   (144,977)    (118,352)
operations
Discontinued operations:
Income from discontinued         132         4,097      2,125        8,111
operations
Gain on sale of discontinued     -           -          51,335       -
operations
Income from discontinued         132         4,097      53,460       8,111
operations
Net loss                       $ (45,380)  $ (38,244) $ (91,517)   $ (110,241)
Basic and diluted net income
(loss) per common share:
 Continuing operations         (0.70)      (0.70)     (2.23)       (2.02)
 Discontinued operations       0.00        0.07       0.82         0.14
                               $ (0.70)    $ (0.63)   $ (1.41)     $ (1.88)
Shares used in computing basic   65,183      60,467     64,966       58,599
and diluted net loss per share



InterMune, Inc.
PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
                                                 September 30,    December 31,
                                                 2012             2011
Cash, cash equivalents and available-for-sale  $ 351,404        $ 425,110
securities
Acquired product rights, net                     18,500           19,250
Other assets                                     32,090           28,263
 Total assets                                 $ 401,994        $ 472,623
Total other liabilities                        $ 41,238         $ 34,205
Convertible notes                                240,250          240,250
Stockholders' equity                             120,506          198,168
 Total liabilities and stockholders' equity   $ 401,994        $ 472,623



SOURCE InterMune, Inc.

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