- Company provides financial and key project guidance -
BRISBANE, Calif., Feb. 26 /PRNewswire-FirstCall/ -- InterMune, Inc.
(Nasdaq: ITMN) today announced results from operations for the fourth quarter
and 12 months ended December 31, 2008. InterMune reported a net loss for the
fourth quarter of 2008 of $32.3 million, or $0.83 per share, compared with a
net loss of $25.9 million, or $0.67 per share, in the fourth quarter of 2007.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune
said, "Fourth quarter and recent events have highlighted our very significant
progress on pirfenidone and ITMN-191 (R7227). We recently reported results of
our Phase 3 CAPACITY program for pirfenidone in idiopathic pulmonary fibrosis
(IPF) and are now preparing the New Drug Application (NDA) and Marketing
Authorization Application (MAA) for the United States and European Union,
respectively. We also reported very positive top-line results of our triple
combination study of ITMN-191 with Pegasys(R) (pegylated interferon alfa-2a)
and Copegus(R) (ribavirin) and launched the innovative all-oral treatment
study, INFORM-1, in patients chronically infected with the hepatitis C virus
(HCV)."
Results for Fourth Quarter 2008
InterMune reported total revenue in the fourth quarter of 2008 of
$7.4 million, compared with total revenue of $9.6 million in the fourth
quarter of 2007. Total revenue in the fourth quarter of 2008 primarily
consisted of Actimmune(R) (interferon gamma-1b) revenue of $6.6 million,
compared with $8.8 million in the fourth quarter of 2007, a decrease of 25%,
reflecting lower off-label physician prescriptions of Actimmune for the
treatment of IPF, which InterMune does not promote. Fourth quarter total
revenue also included revenue from the collaboration with Roche for the
development of protease inhibitors, including ITMN-191, which totaled
$0.8 million in the fourth quarter of 2008, unchanged from the same quarter of
2007.
Research and development (R&D) expenses in the fourth quarter of 2008 were
$26.3 million compared with $25.1 million in the fourth quarter of 2007, an
increase of 5%. General and administrative (G&A) expenses were $7.8 million
in the fourth quarter of 2008, compared with $6.6 million in the same period a
year earlier, an increase of 18%.
During the fourth quarter of 2008, InterMune recorded an
"other-than-temporary" impairment charge of approximately $3.5 million on its
auction-rate securities, reported in the statements of operations.
As of December 31, 2008, InterMune had cash, cash equivalents and
available-for-sale securities of approximately $154.7 million.
Results for the 12 Months Ended December 31, 2008
InterMune also reported results from operations for the full year ended
December 31, 2008. The net loss for the year was $97.7 million, or $2.51 per
share, compared with a net loss of $89.6 million, or $2.52 per share, in 2007.
Total revenue in 2008 was $48.2 million, compared with total revenue of
$66.7 million in 2007, a decrease of 28%. Actimmune revenue totaled
$29.9 million in 2008, compared with $53.4 million of Actimmune revenue in
2007, a decrease of approximately 44%, reflecting lower off-label sales of
Actimmune for the treatment of IPF, which InterMune does not promote.
Revenue from the collaboration with Roche was $18.3 million in 2008, compared
with $13.3 million in 2007. Collaboration revenue in 2008 consisted of a
$15.0 million development milestone and $3.3 million in amortization of the
initial upfront and manufacturing milestone payments.
R&D expenses were $104.6 million in 2008, a 1% decrease compared to
$105.9 million in 2007. G&A expenses were $30.3 million in 2008, essentially
unchanged from $29.6 million in 2007.
Recent Highlights
Pirfenidone:
-- On October 16, 2008 Shionogi & Co., Ltd of Japan, which has rights to
pirfenidone in Japan, reported approval of its j-NDA to market
pirfenidone as Pirespa(R) in IPF.
-- On February 3, 2009, InterMune reported results from its Phase 3
CAPACITY program for pirfenidone in IPF, which consisted of two,
multinational, randomized, double-blind, placebo-controlled clinical
trials named CAPACITY 1 and CAPACITY 2.
- The primary endpoint of change in percent predicted Forced Vital
Capacity (FVC) at Week 72 was met with statistical significance in
CAPACITY 2 (p=0.001), as were the secondary endpoints of categorical
change in FVC (p=0.001) and Progression-Free Survival (p=0.023).
- The primary endpoint was not met in CAPACITY 1 (p=0.501), but
supportive evidence of a pirfenidone treatment effect was observed
on a number of measures and at various time points. In CAPACITY 1,
there was evidence of a pirfenidone treatment effect on the
pre-specified secondary endpoint of Six-Minute Walk Test distance
(p = 0.001) when compared to placebo.
- Pirfenidone was safe and generally well tolerated in both CAPACITY
studies. There was no difference between pirfenidone and placebo in
the percentage of patients that experienced a serious adverse event
(SAE) and the pattern of adverse events (AEs) was, in general,
comparable to that observed in previous clinical studies of
pirfenidone.
- InterMune is preparing an NDA for submission to the FDA, to be
followed by an MAA submission to the European Medicines Agency
(EMEA).
-- InterMune reported that 603 patients from CAPACITY have been enrolled
in RECAP, the on-going open-label roll-over study from CAPACITY to
evaluate the long-term safety of pirfenidone in patients with IPF.
ITMN-191 (R7227):
-- In November 2008, Roche, InterMune and Pharmasset, Inc. initiated the
first all-oral combination study of direct anti-virals in the absence
of interferon or ribavirin, known as the INFORM-1 study. That study
has completed the first dose cohort.
-- On January 12, 2009, InterMune announced top-line results from a
14-day, Phase 1b study of ITMN-191 in combination with Pegasys(R)
(peginterferon alfa-2a) and Copegus(R) (ribavirin).
- After 14 days of triple combination therapy, the median change in HCV
RNA from baseline exceeded 5 log10 in five of the six dosage cohorts
in the study, and was -5.4 log10 and -5.7 log10 in the best
performing q12h and q8h cohorts, respectively.
- Reductions in HCV RNA occurred rapidly and there was no evidence of
viral rebound during ITMN-191 treatment in any cohort.
- ITMN-191 was generally safe and well tolerated in the study. There
were no serious adverse events or Grade 4 adverse events (AEs) during
treatment with ITMN-191. AEs reported during study treatment
(ITMN-191 or placebo) were predominantly mild to moderate in
severity, typically consistent with the AE profile of standard of
care (SOC), and none led to treatment discontinuation.
Financial:
-- On February 19, 2009, InterMune completed a follow-on public offering
of 4,025,000 shares of common stock, including the underwriters'
over-allotment, at an offer price of $16.35 per share. Net proceeds to
InterMune were approximately $63.5 million after deduction of
underwriting fees and other related expenses.
-- The Medicines Company announced on February 25, 2009, that it had
completed its tender offer for all of the outstanding shares of
Targanta Therapeutics Corporation. Based on InterMune's ownership of
approximately 3 million Targanta shares, InterMune expects to receive
approximately $6.0 million in the current quarter as a result of the
transaction.
2009 Key Project Guidance
The company provided guidance on its key development projects, pirfenidone
and ITMN-191.
Pirfenidone
The company plans to submit an NDA to the FDA and an MAA to the EMEA on
pirfenidone in the summer of 2009 and around the end of 2009, respectively.
2009 ITMN-191 Clinical Development Plans and Timeline
InterMune provided an update on the development plan and key milestones
for its protease inhibitor ITMN-191, being developed in collaboration with
Roche as follows:
ITMN-191 MILESTONES AND KEY EVENTS EXPECTED DATE
-- Scientific presentation of Phase 1b triple
combination study Q2, 2009 (EASL)
-- Top-line results of INFORM-1 STAT-C study at EASL Q2, 2009 *
-- Phase 2b initiation by Roche
($20 million payment to InterMune) Summer 2009
-- Presentation of all cohorts of INFORM-1 at AASLD Q4, 2009 *
-- Rapid Viral Response (RVR) data from Phase 2b
(12-week regimen) Q4 '09 or Q1 '10
* Subject to acceptance of scientific abstract
Guidance for 2009 Revenue and Expenses
Revenue
Revenue for 2009, including Actimmune(R) and anticipated milestone
payments from Roche, is expected to be in a range of approximately $40 to $50
million. Actimmune revenue represents approximately 50% of this revenue range.
Operating Expenses
R&D expense is anticipated to be in a range of approximately $90 to $100
million, net of development cost reimbursements under the Roche collaboration.
Of this amount, approximately 60% is attributed to pirfenidone which includes
expenses for CAPACITY, RECAP, the preparation and support of NDA and MAA
submissions and manufacturing.
Approximately 35% of the R&D expense is attributed to the company's
one-third share of all development expenses incurred by the collaboration with
Roche on ITMN-191. InterMune also is working to name a second-generation
protease inhibitor under the Roche/InterMune collaboration. Roche is
responsible for 100% of all R&D costs related to a second-generation protease
inhibitor compound through Phase 1. After Phase 1, Roche pays two-thirds of
all development costs related to the compound. The balance of 2009 R&D
expense is related to the advancement of a named pirfenidone analog compound,
ITMN-520, toward an expected IND filing in mid-2010.
G&A expense is anticipated to be in a range of approximately $35 to $40
million. The G&A guidance range includes approximately $5.0 million of various
pirfenidone pre-marketing costs and a similar amount in legal fees associated
with a Department of Justice (DOJ) action against a former InterMune executive
covered by an indemnification agreement.
Other Expenses
InterMune will incur approximately $1 million in expenses recorded as
Restructuring Charges related to a reduction in force in February 2009.
InterMune will pay a milestone of $13.5 million, which will be expensed as
Acquired R&D and Milestone Expense in 2009, to Marnac and KDL in accordance
with the pirfenidone purchase agreement and the company's decision to submit
NDA and MAA filings on pirfenidone.
Other Uses of Cash in 2009
The company provided information to further guide investors on uses of
cash in 2009.
According to the structure of the company's collaboration agreement with
Roche, approximately $11.4 million of 2008 expenses on ITMN-191 were accrued
and payment to Roche was deferred. This $11.4 million payment will be made to
Roche in 2009.
InterMune will make a scheduled Department of Justice (DOJ) payment of
approximately $7.0 million in 2009. Additionally, the company anticipates that
it may be required to make an accelerated payment to the DOJ of approximately
$4.4 million related to the company's recent financing event. If both of these
DOJ payments are made, the balance of the Liability Under Government
Settlement would be approximately $13.2 million as of December 31, 2009.
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EST to discuss
its financial results for the fourth quarter and full year 2008, and its
forward-looking financial guidance. Interested investors and others may
participate in the conference call by dialing 888-799-0528 (U.S.) or
973-200-3372 (international), conference ID# 86755415. 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
http://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.
The teleconference replay will be available for 10 business days following
the call and can be accessed by dialing 800-642-1687 (U.S.) or 706-645-9291
(international), and entering the conference ID# 86755415. 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 hepatology.
InterMune has a pipeline portfolio addressing idiopathic pulmonary fibrosis
(IPF) and hepatitis C virus (HCV) infections. The pulmonology portfolio
includes the Phase 3 program, CAPACITY, which is evaluating pirfenidone as a
possible therapeutic candidate for the treatment of patients with IPF, RECAP,
an open-label extension study from CAPACITY, and a research program focused on
small molecules for pulmonary disease. The hepatology portfolio includes the
HCV protease inhibitor compound ITMN-191 (referred to as R7227 at Roche) in
Phase 1b, a second-generation HCV protease inhibitor research program, and a
research program evaluating a new target in hepatology. For additional
information about InterMune and its R&D pipeline, please visit
http://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
anticipated product development timelines and the likelihood of regulatory
success. 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. The top-line
efficacy, safety and tolerability data reported in this press release are from
analyses of the highest areas of interest to the company based on the prior
clinical experience with pirfenidone in IPF patients. Pirfenidone failed to
achieve statistical significance on the primary endpoint in one of its two
pivotal clinical trials and there can be no assurance that the regulatory
authorities in either the United States or Europe will grant regulatory
approval based upon this data, in combination with the other efficacy and
safety results the company currently intends to submit in support of its NDA
and MAA filings. Further analyses of the CAPACITY results will be conducted in
the future and additional observations may be made which may lead to material
change in the company's current regulatory strategy for pirfenidone, including
a decision by the company not to proceed with either or both of its regulatory
submissions in the United States and Europe. These analyses and observations
will be included in a presentation of the CAPACITY data that the company
expects to make at the American Thoracic Society (ATS) in the second quarter
of 2009, and/or in a scientific publication.
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
SEC on March 14, 2008 (the "Form 10-K") and other periodic reports filed with
the SEC, including 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 regulation by the FDA and other agencies with respect to InterMune's
communications with physicians concerning Actimmune for the treatment of IPF;
(iii) reimbursement risks associated with third-party payors; (iv) risks
related to whether InterMune is able to obtain, maintain and enforce patents
and other intellectual property; (v) risks related to significant regulatory,
supply and competitive barriers to entry; (vi) risks related to the uncertain,
lengthy and expensive clinical development and regulatory process, including
having no unexpected safety, toxicology, clinical or other issues; (vii) risks
related to achieving positive clinical trial results; (viii) risks related to
timely patient enrollment and retention in clinical trials; (ix) the results
of the InterMune CAPACITY trials of pirfenidone differ in some respects from
those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone and there can
be no assurance that the U.S. or European regulatory authorities will approve
the use of pirfenidone for the treatment of IPF; (x) the results as reported
by Shionogi concerning their Phase 3 trial may differ from those published or
presented in a peer-reviewed forum; and (xi) 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.
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(R) is a registered trademark of InterMune, Inc. Pegasys(R) and
Copegus(R) are registered trademarks of Roche.
Financial tables follow
InterMune, Inc.
PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Year Ended
Dec 31 Dec 31
2008 2007 2008 2007
Revenue, net
Actimmune $6,583 $8,809 $29,880 $53,420
Collaboration revenue 818 818 18,272 13,272
Total revenue, net 7,401 9,627 48,152 66,692
Costs and expenses:
Cost of goods sold 1,713 2,058 8,989 14,109
Research and development 26,274 25,106 104,581 105,939
General and
administrative 7,795 6,611 30,260 29,577
Acquired research and
development milestone - 6,225 - 13,725
Restructuring charges - - - 10,246
Total costs and
expenses 35,782 40,000 143,830 173,596
Loss from operations (28,381) (30,373) (95,678) (106,904)
Interest income 972 2,945 5,616 10,699
Interest expense (1,534) (696) (5,635) (2,881)
Other income (expense) (3,431) (111) (2,145) 2,215
Loss from continuing
operations before income
taxes (32,374) (28,235) (97,842) (96,871)
Income tax
expense/(benefit) - (2,275) - (2,275)
Loss from continuing
operations (32,374) (25,960) (97,842) (94,596)
Discontinued operations:
Income (loss) from
discontinued operations 32 79 103 4,994
Net loss $(32,342) $(25,881) $(97,739) $(89,602)
Basic and diluted loss per
share:
Continuing operations $(0.83) $(0.67) $(2.51) $(2.67)
Discontinued operations - - - 0.15
Net loss per share $(0.83) $(0.67) $(2.51) $(2.52)
Shares used in computing
basic and diluted net loss
per share 39,062 38,753 38,982 35,493
InterMune, Inc.
PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
December 31, December 31,
2008 2007
Cash, cash equivalents and
available-for-sale
securities $154,713 $235,292
Other assets 17,511 27,153
Total assets $172,224 $262,445
Total other liabilities $40,442 $26,430
Liability under government
settlement 23,665 30,642
Deferred collaboration
revenue 62,989 66,261
Convertible senior notes 170,000 170,000
Stockholders' deficit (124,872) (30,888)
Total liabilities and
stockholders' deficit $172,224 $262,445
SOURCE InterMune, Inc.
-0- 02/26/2009
CONTACT:
Jim Goff of InterMune, Inc., +1-415-466-2228,
jgoff@intermune.com
Web site: http://www.intermune.com
