InterMune Reports Third Quarter 2013 Financial Results And Business Highlights
-- Reports 8th Consecutive Quarter of Esbriet Revenue Growth --
BRISBANE, Calif., Oct. 30, 2013
BRISBANE, Calif., Oct. 30, 2013 /PRNewswire/ --InterMune, Inc. (NASDAQ: ITMN)
today announced results from operations for the third quarter and nine months
ended September 30, 2013, and recent business highlights.
InterMune reported Esbriet^® (pirfenidone) revenue in the third quarter of
2013 of $19.7 million, compared with $7.5 million of Esbriet revenue in the
third quarter of 2012, an increase of 163 percent. Sequentially, Esbriet
revenue in the third quarter of 2013 increased 37 percent from $14.4 million
in the second quarter of 2013. Esbriet is InterMune's product marketed in
Europe and Canada for the treatment of adult patients with mild to moderate
idiopathic pulmonary fibrosis (IPF).
Dan Welch, Chairman, Chief Executive Officer and President of InterMune, said,
"Notably, Esbriet revenue growth in the third quarter came from both new
country launches and growth in countries where the product has been available.
During the quarter we launched Esbriet in Italy and the UK, two of the five
largest countries in Europe, as well as in Finland and Ireland. Esbriet
revenue grew in the third quarter in countries where Esbriet had previously
been launched, with Germany, France, the mid-sized European countries and
Canada all reporting sequential double-digit growth. We are particularly
pleased to report strong growth in Germany during the third quarter, where we
see continued market penetration and improved persistence after two full years
of marketing Esbriet in that country."
"Regarding the U.S. market, we remain on track to report top-line results from
the confirmatory Phase 3 ASCEND study of Esbriet in the second quarter of
2014," Mr. Welch added.
Recent Business and Clinical Development Highlights
oIn July 2013, InterMune launched Esbriet in Italy. Up to nine months are
needed in Italy for completion of regional procedures before full
reimbursement for Esbriet is available in all regions of the country.
oIn mid-August 2013, InterMune launched Esbriet in the UK.
oThe company noted that revenue in the first few months following launch in
newly launched countries such as Italy and the UK may be affected by
certain one-time events that are not expected to recur in subsequent
oEsbriet has now been launched in 13 of InterMune's 15 original targeted
European countries in Europe, plus Canada.
oThe company continues discussions with regulatory authorities in Spain and
the Netherlands, two of InterMune's original 15 top-priority European
countries, regarding the pricing and reimbursement of Esbriet. The
company now expects that additional clarity on the status of Esbriet
reimbursement in these two countries will be available during the first
half of 2014.
oThe process of gaining reimbursement from private insurance carriers in
Canada has been largely completed with 90 percent of private plans now
reimbursing Esbriet. Approximately one third of IPF patients in Canada
are covered under private insurance. Reimbursement of a new medicine from
the public plans (provincial and territorial) typically requires
approximately 18-24 months. InterMune currently expects that meaningful
reimbursement from the public plans will begin to be secured in the second
half of 2014 and the process to be concluded in mid-2015.
oStudy conduct in the ASCEND Phase 3 study remains excellent with a level
of patient retention in the study that exceeds 90 percent. More than 90
percent of eligible patients who have completed the ASCEND study have
decided to enter the RECAP open-label extension study in which all
patients receive pirfenidone. ASCEND is InterMune's confirmatory Phase 3
study of Esbriet in 555 IPF patients to support marketing approval in the
United States. InterMune currently expects to report top-line results
from ASCEND in the second quarter of 2014 and intends to present the
results at the May 2014 International Conference of the American Thoracic
Society (ATS) in San Diego.
Third Quarter 2013 Financial Results (Unaudited)
InterMune reported total Esbriet revenue in the third quarter of 2013 of $19.7
million, compared with $7.5 million in the third quarter of 2012, an increase
of 163 percent. Sequentially, Esbriet revenue in the third quarter of 2013
increased 37 percent from $14.4 million in the second quarter of 2013.
Revenue growth in the third quarter of 2013 reflects additional Esbriet
launches in Italy, the UK, Finland and Ireland, as well as continued growth in
countries in which Esbriet had previously been launched. In addition, Esbriet
revenue from non-reimbursed countries contributed about $1.5 million to third
quarter 2013 revenue. InterMune reported total revenue for the first nine
months of 2013 of $44.6 million, compared with $18.0 million in the first nine
months of 2012, an increase of 148 percent.
Research and development (R&D) expenses in the third quarter of 2013 were
$27.3 million, compared with $26.2 million in the third quarter of 2012, an
increase of four percent. R&D expenses were $80.7 million for the nine months
ended September 30, 2013, compared with $74.6 million in the comparable period
of 2012, an increase of eight percent. Higher R&D expenses in both the three
and nine-month periods reflect increased expenses primarily due to conduct of
the ASCEND trial, for which patient enrollment was completed in January of
2013, and the associated expenses of the RECAP study, the open-label roll-over
of ASCEND patients.
Selling, general and administrative (SG&A) expenses were $35.2 million in the
third quarter of 2013, compared with $23.8 million in the same period a year
earlier, an increase of 48 percent. SG&A expenses were $102.5 million in the
first nine months of 2013, an increase of 35 percent from $75.7 million in the
same period of 2012. Increased SG&A expense for the three and nine-month
periods in 2013 compared with the same periods in 2012 is primarily attributed
to the continued development of InterMune's commercial infrastructure and
investments in the pre-launch and launches of Esbriet in Europe and Canada.
InterMune reported a net loss for the third quarter of 2013 of $49.9 million,
or $0.61 per share, compared with a net loss of $40.9 million, or $0.63 per
share, in the third quarter of 2012. Net loss for the first nine months of
2013 was $162.7 million, or $2.03 per share, compared with a net loss of $96.8
million, or $1.49 per share, in the comparable nine months of 2012. The net
loss in the third quarter of 2013 reflects income from discontinued operations
of $0.3 million, or $0.01 per share, net of taxes, related to the divestiture
of the company's rights to Actimmune^® (interferon gamma-1b), which was
completed on June 19, 2012.
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
As of September 30, 2013, InterMune had cash, cash equivalents and
available-for-sale securities of approximately $337.2 million.
Guidance for 2013 Revenue and Operating Expenses
InterMune today updated its forward-looking financial guidance for Esbriet
revenue and reiterated its forward-looking financial guidance for operating
expenses in 2013:
oEsbriet full year 2013 revenue: currently projected to be in a range of
$60 to $70 million (previously projected at $55 to $70 million). With
regard to its 2013 revenue guidance, InterMune also noted the following:
oUp to nine months are needed in Italy for completion of all regional
procedures before full reimbursement for Esbriet is available in all
regions of the country;
oRevenue in the third quarter 2013 in newly launched countries such as
Italy and the UK was affected by certain one-time events in the first
few months of launch that are not expected to recur;
oAdditional information on the status of Esbriet reimbursement in
Spain and the Netherlands is currently expected in the first half of
2014. Therefore, InterMune does not expect to receive reimbursement
of Esbriet in these countries in 2013;
oEsbriet is reimbursed in Canada for approximately 90 percent of the
one-third of IPF patients who are covered under private insurance.
No meaningful public reimbursement of Esbriet is expected until the
second half of 2014;
oThe company anticipates that sequential quarterly revenue growth of
Esbriet will continue. The company also anticipates that the very
high rate of sequential quarterly growth seen in recent quarters will
naturally moderate in subsequent quarters as the one-time effects
typical of new country launches are not repeated and the Esbriet
revenue base increases in absolute terms.
oR&D expense: currently anticipated to be toward the middle of the previous
guidance range of $100 to $120 million.
oSG&A expense: currently anticipated to be toward the lower end of the
previous guidance range of $145 to $165 million.
oTotal Operating Expenses (R&D and SG&A): currently anticipated to be
toward the lower end of the previous guidance range of $245 to $285
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 third quarter and
first nine months of 2013. Interested investors and others may participate in
the conference call by dialing 800-709-0218 (U.S.) or +1 212-231-2901
(international), conference ID# 21682163. A replay of the webcast and
teleconference will be available approximately three hours after the call, and
will remain available on the company's website until the next earnings 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# 21682163.
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, irreversible,
unpredictable and ultimately 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.
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, including Italy, the Netherlands and Spain; InterMune's
expectations regarding the timing of the reimbursement process in Canada;
InterMune's expectation regarding the results of the ASCEND study, including
the timing of availability of such results, and the prospects of success
thereof and meeting the goal of bringing Esbriet to IPF patients in the United
States; InterMune's expectations regarding the moderation in the rate of
sequential revenue growth; 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 March 1, 2013 (the "Form 10-K")
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 and
InterMune's other periodic reports filed with the SEC, including, when
available, its Quarterly Report on Form 10-Q for the three and nine months
ended September 30, 2013, all of which are available via InterMune's web site
Esbriet^® is a registered trademark of InterMune, Inc.
Financial tables follow:
PRELIMINARY CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(unaudited, in thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2013 2012 2013 2012
Esbriet $ 19,718 $ 7,534 $ 44,648 $ 17,952
Costs and expenses:
Cost of goods sold 2,759 2,017 7,078 6,200
Research and development 27,316 26,175 80,723 74,553
Selling, general and 35,219 23,754 102,468 75,680
Total costs and expenses 65,294 51,946 190,269 156,433
Loss from operations (45,576) (44,412) (145,621) (138,481)
Interest income 93 148 345 452
Interest expense (3,667) (2,031) (10,784) (6,473)
Embedded conversion - - 2,422 -
Loss on extinguishment of - - (7,900) -
Other income (expense) (851) 975 (945) (149)
Loss from continuing
operations before income (50,001) (45,320) (162,483) (144,651)
Income tax expense (benefit) 241 (4,319) 1,121 (13,708)
Loss from continuing (50,242) (41,001) (163,604) (130,943)
operations, net of taxes
Income from discontinued 320 84 937 34,139
operations, net of taxes
Net loss $ (49,922) $ (40,917) $ (162,667) $ (96,804)
Basic net income (loss) per
Continuing operations (0.62) (0.63) (2.04) (2.02)
Discontinued operations 0.01 - 0.01 0.53
$ (0.61) $ (0.63) $ (2.03) $ (1.49)
Shares used in computing
basic net income (loss) per 81,397 65,183 80,021 64,966
Shares used in computing
diluted net income (loss) per 81,397 65,183 80,021 64,966
PRELIMINARY CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, in thousands)
September 30, December 31,
Cash, cash equivalents and available-for-sale $ 337,244 $ 307,986
Acquired product rights, net 17,500 18,250
Other assets 53,162 37,230
Total assets $ 407,906 $ 363,466
Total other liabilities $ 49,227 $ 56,899
Convertible notes 263,611 240,250
Stockholders' equity 95,068 66,317
Total liabilities and stockholders' equity $ 407,906 $ 363,466
SOURCE InterMune, Inc.
Contact: Jim Goff, InterMune, Inc., +1-415-466-2228, firstname.lastname@example.org
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