InterMune Reports First Quarter 2012 Financial Results And Business Highlights

InterMune Reports First Quarter 2012 Financial Results And Business Highlights

PR Newswire

BRISBANE, Calif., April 26, 2012

BRISBANE, Calif., April 26, 2012 /PRNewswire/ -- InterMune, Inc. (Nasdaq:
ITMN) today announced results from operations for the first quarter ended
March 31, 2012. InterMune also highlighted its recent clinical development and
business activities.

InterMune reported product revenue in the first quarter of 2012 of $8.9
million, consisting of approximately $4.9 million from sales of Esbriet®
(pirfenidone) in Europe, and Actimmune® (gamma interferon-1b) revenue of
approximately $4.1 million.  Esbriet is InterMune's product indicated in
adults for the treatment of mild-to-moderate idiopathic pulmonary fibrosis
(IPF).  InterMune's product sales in the first quarter of 2011 consisted
solely of $5.1 million of Actimmune revenue, as the initial commercial launch
of Esbriet was in Germany in September 2011. 

Dan Welch, Chairman, Chief Executive Officer and President of InterMune said,
"Our launch in Germany, the EU's largest pharmaceutical market, continues to
go well as Esbriet revenue in the first quarter of 2012 nearly doubled from
the prior quarter, revenue increased each month in succession and we continued
to see a solid number of new patient starts each month.  Our launch continues
to compare very favorably in terms of revenues and patient starts to the best
specialty product launches in Germany.  This performance is encouraging given
the ambiguity created by the preliminary assessment of Esbriet's added value
by IQWiG on December 15 which was favorably resolved on March 15, 2012 when
the G-BA granted the additional benefit of Esbriet.

"We are pleased to report that approximately 1,800 patients have initiated
Esbriet therapy in Europe to date, either on commercial drug in the countries
where Esbriet is already available or in the company's Named Patient Program
(NPP), underscoring the strong demand for the first approved IPF therapy in
the European Union."  

InterMune reported that an estimated 363 additional new patients initiated
Esbriet therapy in Germany during the first quarter of 2012, compared with the
estimated 402 patients who were prescribed Esbriet as new patients in Germany
during the fourth quarter of 2011.  InterMune reported that as of April 13,
2012, a total of 838 patients were enrolled in the company's NPP across Europe
outside of Germany, compared to a total 410 patients who were enrolled in the
NPP outside of Germany at the end of 2011.  This brings the total number of
patients enrolled in the NPP since its inception, including those recruited in
Germany before launch, to more than 1,000 patients and the total number of
patients estimated to have initiated Esbriet therapy (through NPP or through
commercial product) to more than 1,800. 

The NPP allows qualified physicians to make Esbriet available to their IPF
patients free of charge, if they meet certain pre-specified medical criteria
and conditions, before Esbriet is commercially available in a given country. 
The program was initiated in April of 2011 for a period of 12 months. 
InterMune today announced that new patients may continue to be enrolled in the
NPP through June 30, 2012.

"During the first quarter of 2012, we made very meaningful progress on Esbriet
pricing and reimbursement in Europe and Esbriet is now reimbursed in five
countries," Mr. Welch continued.  "We made an important positive step in
Germany, the largest market in Europe, when we secured a favorable ruling
regarding the additional benefit of Esbriet and we recently announced a very
important step forward in France, the EU's second-largest market, with the
news of the Transparency Commission's favorable opinion regarding the
reimbursement of Esbriet in France."

Recent Business and Clinical Development Highlights

Esbriet^® (pirfenidone): 

  o Subject to EU country reimbursement timelines, InterMune currently plans
    to conclude pricing and reimbursement discussions related to Esbriet in
    France, Spain and Italy during the fourth quarter of 2012 and in the
    United Kingdom in the first quarter of 2013 (previously Q4 2012), and to
    launch Esbriet in those countries as soon as possible and practical after
    successfully concluding discussions. 
  o In addition, the company expects to begin full-scale launches of Esbriet
    in Denmark, Norway and Luxembourg in the first half of 2012, and in
    Austria, Belgium, the Netherlands, Finland, Ireland and Sweden in the
    second half of the year, assuming favorable pricing and reimbursement.
     Esbriet revenues in these latter countries are anticipated to be modest
    in 2012 and to become more meaningful in 2013. 
  o On March 15, 2012, the G-BA, the highest decision-making authority in
    Germany's self-governing health care system, issued a binding decision
    granting an additional benefit to Esbriet.  InterMune is now engaged in
    negotiating the price of Esbriet in Germany with the umbrella organization
    of the sick funds, the public insurers who reimburse the cost of medicines
    in that country.  Negotiations are expected to be concluded by September
    15, 2012. 
  o On April 5, 2012, InterMune reported that the Transparency Commission (CT)
    of the French National Health Authority (HAS) had issued a favorable
    opinion for the reimbursement of Esbriet by French National Health
    Insurance.  The CT noted that no other treatment provided evidence of a
    clinical benefit in IPF and considering all available information, Esbriet
    was granted an Amelioration du Service Medical Rendu (ASMR) rating of
    level IV.  ASMR is a rating of added clinical value in comparison with
    existing therapies.  The CT focused also on the risk/benefit ratio for
    assessing the actual medical benefit (Service Medical Rendu – SMR), and
    rated it as "Low."
  o InterMune on April 5, 2012, reported that the Phase 3 pirfenidone study,
    ASCEND, in the United States and certain additional territories is
    currently expected to be fully enrolled around the end of 2012.  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 will enroll approximately 500 IPF patients with
    mild-to-moderate impairment in lung function.  InterMune expects that
    results from the study will be available in the first half of 2014.

First Quarter 2012 Financial Results (Unaudited)

InterMune reported total revenue in the first quarter of 2012 of $8.9 million,
compared with $6.4 million in the first quarter of 2011.  Total revenue in the
first quarter of 2012 included $4.9 million of revenue from sales of Esbriet
in Europe.  There were no sales of Esbriet in the first quarter of 2011, as
Esbriet's initial commercial launch was in Germany in September 2011. 
Actimmune® (gamma interferon-1b) revenue was approximately $4.1 million in the
first quarter of 2012 compared with $5.1 million in the first quarter of 2011.
 InterMune reported no collaboration revenue in the first quarter of 2012
following completion of its research collaboration with Roche in June
2011.     

Research and development (R&D) expenses in the first quarter of 2012 were
$23.2 million compared with $16.8 million in the first quarter of 2011, an
increase of 38 percent.  Higher R&D expenses reflect increased expenses due to
conduct of the ASCEND trial, which was initiated in July 2011, partially
offset by decreased expenses associated with a discontinuation of investment
in the HCV portfolio following the divestiture of danoprevir in October of
2010 and completion of InterMune's research agreement with Roche in June
2011. 

Selling, general and administrative (SG&A) expenses were $27.3 million in the
first quarter of 2012, compared with $17.6 million in the same period a year
earlier, an increase of 55 percent.  The increased spending for the
three-month period in 2012 compared with the same period in 2011 is attributed
to the creation of InterMune's European infrastructure and investments in the
pre-launch and launch of Esbriet in Europe, including but not limited to
additional headcount.   

InterMune reported a net loss for the first quarter of 2012 of $47.6 million,
or $0.74 per share, compared with a net loss of $32.1 million, or $0.57 per
share, in the first quarter of 2011.

As of March 31, 2012, InterMune had cash, cash equivalents and
available-for-sale securities of approximately $377.2 million.   

Guidance for 2012 Expenses

The company reported that it is actively reviewing its forward-looking
financial guidance for operating expenses in 2012, and that it expects to
provide updated expense guidance for 2012 when the review is completed within
the next several weeks.  The review is intended to align the level of Selling,
General and Administrative expenses anticipated in 2012 with recently revised
timelines for the completion of pricing and reimbursement discussions for
Esbriet in Europe and to assess the company's 2012 R&D investment plans
including, but not limited to, the anticipated enrollment schedule in the
ASCEND Phase 3 trial. 

Conference Call and Webcast Details

InterMune will host a live webcast of a conference call today at 4:30 p.m. EDT
to discuss business highlights and financial results for the first quarter
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# 21589296.  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 the conference ID# 21589296.  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, we are 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 as Esbriet® and is currently in
a Phase 3 clinical trial in the United States.  Pirfenidone is also approved
for the treatment of IPF in Japan, where it is marketed by Shionogi & Co. Ltd.
under the trade name Pirespa®.  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 the statements related to our
expectations for Esbriet as an important therapy in the treatment of patients
with IPF, our anticipated timing of commercial launches for Esbriet®
(pirfenidone) in France, Italy, Spain, the United Kingdom and other EU
countries, our expectations regarding headcount in our EU commercial
organization, and our expectation regarding the timing of full enrollment in
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"), and other periodic reports filed with the SEC, including but not
limited to the following: (i) the fact that physician prescriptions of
Actimmune for the treatment of IPF, an indication for which Actimmune has not
been approved by the FDA, have declined significantly following the March 2007
termination of the Phase 3 INSPIRE trial of Actimmune in IPF and the risk that
InterMune's revenue will continue to decline as expected; (ii) risks related
to significant regulatory, supply and competitive barriers to entry with
respect to Actimmune; (iii) 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;
(iv) 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; (v) risks related to unexpected regulatory actions or delays or
government regulation generally; (vi) 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;
(vii) government, industry and general public pricing pressures; (viii) risks
related to our ability to successfully launch and commercialize Esbriet in the
EU, including successfully establishing a commercial operation in the EU and
receiving favorable governmental pricing and reimbursement approvals in each
EU country; and (ix) 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
InterMune's other periodic reports filed with the SEC, all of which are
available via InterMune's web site at www.intermune.com.     

Actimmune® and Esbriet® are registered trademarks of InterMune, Inc.  

Financial tables follow: 

 InterMune, Inc.
 PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 (unaudited, in thousands, except per share amounts)
                                                     Three Months Ended
                                                     March 31
                                                     2012        2011
 Revenue, net
   Actimmune                                       $ 4,056     $ 5,052
   Esbriet                                           4,880       -
   Collaboration revenue                             -           1,300
    Total revenue, net                               8,936       6,352
 Costs and expenses:
   Cost of goods sold                                2,886       2,286
   Research and development                          23,212      16,838
   Selling, general and administrative               27,306      17,576
     Total costs and expenses                        53,404      36,700
 Loss from operations                                (44,468)    (30,348)
 Interest income                                     145         138
 Interest expense                                    (2,205)     (1,787)
 Other expense                                       (1,016)     (106)
 Loss from operations before income taxes            (47,544)    (32,103)
 Income tax expense                                  65          -
 Net loss                                          $ (47,609)  $ (32,103)
 Basic and diluted loss per share:
 Net loss per share                                $ (0.74)    $ (0.57)
 Shares used in computing basic and diluted net      64,658      56,377
 loss per share

 InterMune, Inc.
 PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
 (unaudited, in thousands)
                                             March 31    December 31,
                                             2012        2011
 Cash, cash equivalents and                $ 377,236   $ 425,110
 available-for-sale securities
 Acquired product rights, net                19,000      19,250
 Other assets                                38,749      28,263
   Total assets                            $ 434,985   $ 472,623
 Total other liabilities                   $ 37,921    $ 34,205
 Convertible senior notes                    240,250     240,250
 Stockholders' equity                        156,814     198,168
   Total liabilities and stockholders'     $ 434,985   $ 472,623
 equity

 

SOURCE InterMune, Inc.