- Several Potential Catalysts Expected in Next Six Months -
BRISBANE, Calif., July 31 /PRNewswire-FirstCall/ -- InterMune, Inc. (Nasdaq: ITMN) today announced results from operations for the second quarter and six months ended June 30, 2008. InterMune reported a net loss for the second quarter of 2008 of $26.5 million, or $0.68 per share, compared with a net loss of $19.8 million, or $0.58 per share, in the second quarter of 2007.
Dan Welch, Chairman, Chief Executive Officer and President of InterMune said, "The second quarter of 2008 was an exciting period for InterMune. We reported substantial progress on our collaboration with Roche with ITMN-191 (R7227) by reporting top-line results from our 14-day monotherapy study, reporting the successful completion of 13-week preclinical toxicology studies in two species that enable our Phase 2 studies and announcing the initiation of our 14-day study of ITMN-191 plus standard of care therapy."
Mr. Welch continued, "The next six months will be a very rich period in terms of data and milestones for InterMune. At the AASLD meeting in late October, we expect to present the results of our two completed clinical studies of ITMN-191 as well as the results of non-clinical studies of ITMN-191 in combination with direct antiviral compounds in the Roche portfolio. During the fourth quarter, we expect to announce top-line results from our on-going 14-day study of ITMN-191 plus standard of care therapy and in January of 2009, we expect to report top-line results from our Phase 3 CAPACITY program for pirfenidone in idiopathic pulmonary fibrosis, a fatal disease for which no treatments are approved."
Results for Second Quarter 2008
InterMune reported total revenue in the s:
Continuing operations $(0.68) $(0.58) $(1.36) $(1.19)
Discontinued operations - - - -
Net loss per share $(0.68) $(0.58) $(1.36) $(1.19)
Shares used in computing
basic and diluted net loss
per share 38,956 34,315 38,915 34,190
PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
June 30, December 31,
Cash, cash equivalents and
securities $188,317 $235,292
Other assets 22,038 27,153
Total assets $210,355 $262,445
Total other liabilities $27,749 $26,430
Liability under government
settlement 29,449 30,642
revenue 64,625 66,261
Convertible senior notes 170,000 170,000
Stockholders' deficit (81,468) (30,888)
Total liabilities and
stockholders' deficit $210,355 $262,445econd quarter of 2008 of $8.1 million, compared with total revenue of $25.4 million in the second quarter of 2007. Total revenue in the second quarter of 2008 primarily consisted of Actimmune(R) (interferon gamma-1b) revenue of $7.3 million, compared with $14.5 million of Actimmune revenue in the same quarter of 2007, a decrease of approximately 50%, reflecting lower off-label physician prescriptions of Actimmune for the treatment of idiopathic pulmonary fibrosis (IPF), which InterMune does not promote. Revenue from the collaboration with Roche for the development of protease inhibitors, including ITMN-191 (R7227), totaled $0.8 million in the second quarter of 2008, compared with $10.8 million in the same quarter of 2007, which included receipt of a $10.0 million development milestone payment from Roche.
Research and development (R&D) expenses in the second quarter of 2008 were $25.5 million compared with $28.0 million in the second quarter of 2007, a decrease of approximately 9%. General and administrative (G&A) expenses were $7.1 million in the second quarter of 2008, unchanged from the same period a year earlier.
As of June 30, 2008, InterMune had cash, cash equivalents and available- for-sale securities of approximately $188.3 million, compared with $211.0 million as of March 31, 2008.
Results for the Six Months Ended June 30, 2008
InterMune also reported results from operations for the six months ended June 30, 2008. The net loss for the period was $52.9 million, or $1.36 per share, compared with a net loss of $40.6 million, or $1.19 per share, in the first six months of 2007.
Total revenue in the first half of 2008 was $17.4 million, compared with total revenue of $45.7 million in the same period of 2007, a decrease of 62%. Actimmune revenue totaled $15.8 million in the first six months of 2008, compared with $34.1 million of Actimmune revenue in the first six months of 2007, a decrease of approximately 54%, reflecting lower off-label sales of Actimmune for the treatment of IPF, which InterMune does not promote. Revenue from the collaboration with Roche was $1.6 million in the first six months of 2008, compared with $11.6 million in the same period of 2007.
R&D expenses were $52.6 million in the first six months of 2008, an 8%
decrease compared to $57.4 million in the same period of 2007. This
decrease was primarily due to termination of the INSPIRE Phase 3 trial of
Actimmune in March 2007. G&A expenses of $14.6 million in the first half of
2008 were approximately 12% lower than $16.6 million in the first six
months of 2007, reflecting headcount reduction and cost-control initiatives
following termination of the INSPIRE trial.
Second Quarter Highlights
-- Shionogi & Co., Ltd of Japan, which has rights to pirfenidone in
Japan, reported results of its Phase 3 study in Japan at the
American Thoracic Society meeting in Toronto on May 20. Following
the presentation, InterMune noted the following:
-- The baseline characteristics of patients enrolled in the
Shionogi Phase 3 trial and the InterMune Phase 3 CAPACITY
program are extremely similar.
-- The Shionogi Phase 3 trial confirmed the results reported by
Shionogi from their Phase 2 trial; notably a positive effect of
pirfenidone on the rate of decline in Vital Capacity over time
and an acceptable safety profile.
-- The number of patient dropouts in the Shionogi study was
consistent with that of other multi-center studies of other
compounds in IPF and the nature of the dropouts in the Shionogi
study may have underestimated the treatment effect of
-- The study conduct of CAPACITY is excellent and InterMune
expects to achieve its goal of having no more than 5% of
patients lost to follow-up at the time of the week 72
-- On April 2, InterMune reported top-line results in the four dose
cohorts of treatment-naive patients chronically infected with
hepatitis C virus (HCV) genotype 1 in its Phase 1b multiple-
ascending-dose (MAD) monotherapy trial of ITMN-191:
-- Day 14 median viral kinetic results competitive with those
published for other direct antiviral compounds when used in
monotherapy for 14 days. Specifically, InterMune reported a
median 3.8 log reduction (equal to 99.98% reduction) in HCV RNA
from baseline at Day 14;
-- Significant and rapid viral kinetic activity when dosed every
12 hours; and
-- Excellent safety and tolerability in all dosage regimens.
-- InterMune reported successful completion of 13-week toxicology
studies in rats and monkeys at exposures higher than those expected
to be evaluated in clinical studies. These preclinical studies were
required before initiating the Phase 2 program of ITMN-191 which
will involve durations of therapy longer than those studied in Phase
-- Announced on May 29 the initiation of a 14-day study of ITMN-191 in
combination with Pegasys(R) (pegylated interferon alpha-2a) and
Copegus(R) (ribavirin). The study is proceeding as planned.
-- Submitted several abstracts for possible presentation at the 59th
Annual Meeting of the American Association for the Study of Liver
Diseases (AASLD) to be held October 31 - November 4, 2008 in San
Francisco, including but not limited to data on ITMN-191.
-- On June 24, InterMune exchanged $85 million of its $170 million of
outstanding convertible notes with certain existing debt holders.
As a result, the amount of outstanding convertible notes is
unchanged, but now consists of two tranches: $85 million of 0.25%
convertible notes due 2011 and $85 million of 5.00% convertible
notes due 2015.
-- Holders of the 2011 notes may convert those notes at a conversion
price of approximately $21.63 per share. Holders of the 2015 notes
may convert their notes into shares of InterMune common stock at a
conversion price of approximately $18.88 per share, which is subject
to decrease in certain circumstances.
-- The debt restructuring effectively extended the maturity date of $85
million of InterMune's total $170 million of outstanding convertible
notes by four years with relatively modest dilution.
For additional information regarding InterMune's debt exchange, please refer to InterMune's Reports on Form 8-K filed on June 10, 2008 and June 24, 2008.
Guidance for 2008 Operating Expenses
InterMune today reiterated its guidance with respect to operating expenses in 2008.
For the year ending December 31, 2008, R&D expense is anticipated to be in a range of approximately $100 to $110 million, net of development cost reimbursements under the Roche collaboration. G&A expense is anticipated to be in a range of approximately $25 to $30 million.
Key Development Program Milestones - Next Six Months
InterMune today noted the upcoming milestones expected during the next
six months on its key development programs.
CAPACITY Program in IPF:
-- InterMune expects to announce top-line results of its Phase 3
CAPACITY program in IPF in January of 2009.
-- If Shionogi's jNDA is approved, Shionogi has announced that it would
launch pirfenidone in Japan in its current fiscal year, which ends
on March 31, 2009.
ITMN-191 Program in HCV:
-- Assuming submitted abstracts will be accepted, InterMune expects to
present several abstracts on ITMN-191 at AASLD, scheduled for
October 31 - November 4 in San Francisco. These abstracts pertain
to various clinical studies on ITMN-191 and in-vitro studies of
ITMN-191 in combination with other direct antiviral compounds.
-- InterMune expects to announce top-line results from the currently
running 14-day study of ITMN-191 in combination with Pegasys and
ribavirin in the fourth quarter of 2008.
Conference Call and Webcast Details
InterMune will host a conference call today at 4:30 p.m. EDT to discuss its financial results for the second quarter 2008, its forward-looking financial guidance and its clinical development programs. Interested investors and others may participate in the conference call by dialing 888-799-0528 (U.S.) or 706-634-0154 (international), conference ID# 57393097. 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# 57393097. The webcast will remain available on the company's website until the next earnings call.
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 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.
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 future financial results and product development. 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.
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 may differ materially from those of the Shionogi & Co., Ltd. Phase 3 trial of pirfenidone; (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 http://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
PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Six Months Ended
June 30 June 30
2008 2007 2008 2007
Actimmune $7,296 $14,533 $15,792 $34,058
Collaboration revenue 818 10,818 1,636 11,636
Total revenue, net 8,114 25,351 17,428 45,694
Costs and expenses:
Cost of goods sold 2,398 3,276 5,584 8,560
Research and development 25,461 27,956 52,642 57,395
administrative 7,119 7,090 14,586 16,586
Restructuring charges - 8,596 - 9,929
Total costs and
expenses 34,978 46,918 72,812 92,470
Loss from operations (26,864) (21,567) (55,384) (46,776)
Interest income 1,272 2,544 3,432 5,244
Interest expense (1,910) (745) (2,581) (1,459)
Other income (expense) 987 (40) 1,268 2,522
Loss from continuing
operations before income
taxes (26,515) (19,808) (53,265) (40,469)
Income tax benefit - - (325) -
Loss from continuing
operations (26,515) (19,808) (52,940) (40,469)
Income (loss) from
discontinued operations (4) 16 74 (128)
Net loss $(26,519) $(19,792) $(52,866) $(40,597)
Basic and diluted loss per
|SOURCE InterMune, Inc.|
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