Actelion announces third quarter 2010 financial results
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Actelion Pharmaceuticals Ltd /
Actelion announces third quarter 2010 financial results
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Product sales of CHF 445.7 million, up 9 percent in local currencies - Total
net revenues of CHF 451.2 million in adverse currency environment - Non-GAAP
EBIT of CHF 141.3 million, up 1% in local currencies - Clazosentan CONSCIOUS-3
enrollment discontinued - Share Repurchase Program to enhance Earnings-Per-Share
ALLSCHWIL/BASEL, SWITZERLAND - 21 October 2010 - Actelion Ltd (SIX: ATLN) today
announced financial results for the third quarter 2010.
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | Q3 2010 | Q3 2009 | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Net Revenues | 451.2 | 447.3 | 1 | 6
-----------------------------+---------+---------+------------+------------
Non-GAAP OPEX | 309.9 | 290.1 | 7 | 8
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 141.3 | 157.2 | (10) | 1
-----------------------------+---------+---------+------------+------------
Diluted EPS - Non-GAAP | 1.21 | 1.17 | 3 | 14
-----------------------------+---------+---------+------------+------------
Diluted EPS - US GAAP | 0.87 | 0.88 | (1) | 12
As of 30 September 2010, Actelion had cash, cash equivalents and marketable
securities of CHF 1.4 billion. In addition, Actelion holds 10.3 million treasury
shares.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "Given
the challenging market conditions in the pharmaceutical industry, I am satisfied
with the ongoing commercial performance of our marketed products. In clinical
development the Phase III study of clazosentan in non-traumatic subarachnoid
hemorrhage disappointingly did not meet its primary endpoint and consequently we
have also taken the decision to discontinue enrollment into the second Phase III
study with clazosentan."
Jean-Paul Clozel added: "Strategically, Actelion is committed to growing and
strengthening its PAH franchise: New molecules including macitentan and
selexipag will enable us to build on the success of Tracleer. As an independent
company, we are best positioned to achieve this goal as well as to continue to
innovate in other disease areas."
Jean-Paul Clozel concluded: "Given our confidence in the performance of our
marketed products, our pipeline and our commitment to managing our cost base in
response to a challenging environment for innovative medicines, we're pleased to
commence an 800 million Swiss Franc share repurchase program that enhances
Earnings-Per-Share (EPS) for our shareholders. The size of the repurchase
program leaves the company with full strategic flexibility to pursue appropriate
product acquisitions and to engage in partnerships for several of our innovative
compounds when appropriate to maximize their value."
Andrew J. Oakley, Chief Financial Officer of Actelion commented on the third
quarter 2010: "On an operational level, I am pleased with the solid top-line
growth for our marketed products. However, both top and bottom-line have been
adversely impacted by pricing pressure as well as by an unfavorable currency
environment."
Andrew J. Oakley continued: "In addition, legal costs have increased due to a
previously announced lawsuit filed against Actelion Ltd and certain
subsidiaries in a Californian Superior Court in relation to the CoTherix
acquisition. Actelion has reviewed the accusations, disagrees with the factual
and legal assertions, and is preparing to defend itself against the claims in a
jury trial set to begin in January 2011."
Andrew Oakley added: "Unforeseen events excluded, I can confirm Actelion's
financial guidance for 2010, with top-line growth expected to be above 10
percent in local currencies and Non-GAAP EBIT to increase - again in local
currencies - between 21 and 24 percent."
Andrew Oakley concluded: "For 2011, I assume that ongoing pricing pressure will
result in product sales - in local currencies - to increase in the mid-single
digit range. Despite improvements on the operational level resulting from our
commitment to carefully control our cost base, the 2011 Non-GAAP EBIT is
expected to be below 2010 levels, especially due to the recognition of S1P1
milestone revenues during 2010 that will not be repeated."
Revenue performance
Product sales for the third quarter of 2010 were CHF 445.7 million (Q3 2009 CHF
431.4 million), an increase of 9 percent in local currencies with 45 percent
coming from the United States, 38 percent from Europe and 17 percent from the
rest of the world. Product sales growth was mostly driven by patient demand.
Sales in the third quarter of 2010 of Tracleer® (bosentan) increased by 12
percent in local currencies and reached CHF 399.8 million compared to CHF 375.5
million for the same period in 2009.
During the third quarter of 2010, Ventavis® (iloprost) had sales in the United
States of CHF 28.9 million compared to CHF 40.0 million in the third quarter of
2009. Q3 2009 was the last quarter of Ventavis® as the only inhaled therapy for
PAH.
The US launch of Actelion's fourth product, Veletri® (epoprostenol for
injection), a parenteral prostacyclin formulation providing the efficacy of
epoprostenol with an increased stability at room temperature without the use of
ice packs, is proceeding well in line with our expectation. Sales of this
product in the third quarter amounted to CHF 0.8 million.
Sales of Zavesca® (miglustat) for the third quarter of 2010 increased by 11
percent in local currencies to reach CHF 16.2 million compared to CHF 15.9
million during the same period last year. The multicenter, open-label, non-
comparative, prospective study MAINTENANCE with miglustat (Zavesca®) in patients
who transferred from enzyme replacement therapy to oral Zavesca® has recently
been successfully concluded. Data analysis is ongoing and the study findings
will be discussed at upcoming scientific meetings.
Otto Schwarz, President of Business Operations of Actelion commented: "Demand
has remained very satisfactory for all of our marketed products. Austerity
measures in many markets and the US healthcare reform are increasing the pricing
pressure and are also affecting, in some territories, health care utilization.
Going forward, we will continue to focus on both our top-line growth
opportunities as well as operational efficiencies."
Contract revenues for the third quarter of 2010 were CHF 5.5 million compared to
CHF 15.9 million in the third quarter of 2009. This reduction is the result of
the milestones from the selective S1P1 receptor agonist collaboration with Roche
being fully recognized as of June of 2010 and milestone recognition period
associated with the development of almorexant being lengthened.
Operating expenses
Total operating expenses for the third quarter of 2010 were CHF 350.9 million
compared to CHF 326.9 million for the same period in 2009, an increase of 7
percent. The increase was driven by ongoing investments into both R&D as well as
to further expand the use of our marketed products.
Research and Development (R&D) expenses in the third quarter of 2010 were CHF
113.7 million compared to CHF 109.3 million in the third quarter of 2009. Non-
GAAP R&D expenses for the third quarter of 2010, which excludes stock-based
compensation expense and amortization and depreciation, were CHF 99.4 million
compared to CHF 97.2 million in the third quarter of 2009.
Selling, General and Administrative expenses (SG&A) for the third quarter of
2010 were CHF 177.0 million compared to CHF 149.9 million in the third quarter
of 2009. Non-GAAP SG&A expenses for the third quarter of 2010, which excludes
stock-based compensation expense and amortization and depreciation, were CHF
161.3 million compared to CHF 136.1 million in the third quarter of 2009.
Operating income
Operating income for the third quarter of 2010 was CHF 100.3 million compared to
CHF 120.4 million for the same period in 2009, a decrease of 2 percent in local
currencies.
In order to better reflect the company's profitability, Actelion continues to
report non-GAAP EBIT, which excludes employee stock options, amortization and
depreciation as well as other one-off charges that distort comparison.
Non-GAAP EBIT for the third quarter of 2010 was CHF 141.3 million, an increase
of 1 percent in local currencies compared to the same period last year.
Net income
Net income for the third quarter of 2010 amounted to CHF 105.3 million compared
to CHF 108.5 million during the third quarter of 2009.
Net income for the period includes interest income of CHF 0.7 million, interest
expense of CHF 1.1 million, amortization of debt discount of CHF 4.7 million,
other financial income of CHF 22.8 million as well as an income tax expense of
CHF 12.7 million.
US GAAP earnings per share on a fully diluted basis in the third quarter of
2010 decreased by 1 percent to CHF 0.87 compared to the same period a year ago.
Non-GAAP earnings per share on a fully diluted basis increased by 3 percent to
CHF 1.21.
Clinical Development
On 27 September 2010, Actelion announced the initial results of CONSCIOUS-2, a
clinical study evaluating the safety and efficacy of clazosentan in reducing
vasospasm-related morbidity and all-cause mortality in clipped patients
following aneurysmal subarachnoid hemorrhage (aSAH). The primary endpoint was
not met, showing a non-significant relative risk reduction of 17 percent in
favor of clazosentan (p=0.1).
Following recent consultations with the Steering Committee of CONSCIOUS-3, a
clinical study similar to CONSCIOUS-2, Actelion has now taken the decision to
discontinue enrollment in this study. Actelion will now collect and analyze all
data from CONSCIOUS-3 and other clazosentan studies.
All other clinical development programs are proceeding as outlined in the
company's Half-Year report issued on 20 July 2010.
Upcoming events
* Actelion to report FY 2010 financial results on 17 February 2011
* Actelion will hold its Annual General Meeting on 05 May 2011
###
For Documentation Purposes
Full Financial Statement:
The full financial statement for the third quarter of 2010 can be found as a PDF
attached to the media release. It is also available onwww.actelion.com in the
Investor section
(http://www.actelion.com/en/investors/financial-information/finance-
archive/index.page?)
Non-GAAP to US GAAP reconciliation for Q3 2010
In CHF Million | Q3'10 | Q3'09
--------------------------------+-------+-------
Non-GAAP EBIT | 141.3 | 157.2
--------------------------------+-------+-------
Stock option expenses | 21.0 | 18.9
--------------------------------+-------+-------
Amortization and depreciation | 19.9 | 17.9
--------------------------------+-------+-------
Operating income | 100.3 | 120.4
Key Financial Figures for 9M 2010
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | 9M 2010 | 9M 2009 | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Net Revenues | 1,476.1 | 1,302.5 | 13 | 17
-----------------------------+---------+---------+------------+------------
Non-GAAP OPEX | 929.6 | 840.5 | 11 | 12
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 546.4 | 462.0 | 18 | 26
-----------------------------+---------+---------+------------+------------
Diluted EPS - Non-GAAP | 3.95 | 3.48 | 13 | 21
-----------------------------+---------+---------+------------+------------
Diluted EPS - US GAAP | 2.96 | 2.66 | 11 | 19
Non-GAAP to US GAAP reconciliation for 9months 2010
In CHF Million | 9M 2010 | 9M 2009
-------------------------------+---------+---------
Non-GAAP EBIT | 546.4 | 462.0
-------------------------------+---------+---------
Stock option expenses | 62.2 | 53.4
-------------------------------+---------+---------
Amortization and depreciation | 57.3 | 45.3
-------------------------------+---------+---------
Operating income | 426.9 | 363.2
Notes to the editor:
Actelion Ltd.
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland. Actelion, founded in late 1997, is a leading player in innovative
science related to the endothelium - the single layer of cells separating every
blood vessel from the blood stream. Actelion's over 2,400 employees focus on
the discovery, development and marketing of innovative drugs for significant
unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange
(ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market
Index SMI®).
For further information please contact:
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com
Conference Call Information
An investor conference call & webcast will be held at 14.00 hrs, CEST to discuss
the results as well as to provide an update on the development pipeline.
Date/Time:
21 October 2010 14.00 hrs - 15.00 hrs Basel (CET)
13.00 hrs - 14.00 hrs UK (GMT)
08.00 a.m. - 09.00 a.m. US (EST)
Conference Call Connect #:
Dial-in participants should start calling the number below 10-15 minutes before
the conference is due to start.
Dial: Europe: +41 44 580 64 03
UK: +44 203 147 47 53
US: +1 866 931 15 72
Participant's mode:
Listen-Only with possibility to open individual lines during Q&A session.
Participants will be asked for their Name and Company.
Webcast Access:
Webcast participants should visit the Actelion websitehttp://www.actelion.com/
10-15 minutes before the conference is due to start. If you experience any
access problems go directly to the
http://gaia.world-television.com/actelion/20101021/trunc
Participant's mode:
Listen-Only with possibility to ask individual questions by clicking on the Q&A
button.
Participants will be asked to provide their Name and Company.
Webcast Replay:
The archived Investor Webcast will be available for replay
throughhttp://www.actelion.com/
approximately 60 minutes after the call has ended.
[HUG#1453551]
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Financial Statement:
http://hugin.info/131801/R/1453551/394064.pdf
Webcast:
http://gaia.world-television.com/actelion/20101021/trunc
Financial Fact Sheet:
http://hugin.info/131801/R/1453551/394063.pdf
Press Release PDF:
http://hugin.info/131801/R/1453551/394055.pdf
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Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
Unternehmensinformation / Kurzprofil:
Datum: 21.10.2010 - 07:00 Uhr
Sprache: Deutsch
News-ID 45970
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contact information:
Town:
Allschwil
Kategorie:
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