Actelion announces Full Year 2010 financial results
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Actelion Pharmaceuticals Ltd /
Actelion announces Full Year 2010 financial results
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Earnings growth exceeds revenue growth - Product sales of CHF 1,826.3 million,
up 12% in local currencies - Total net revenues of CHF 1,929.0 million up 13% in
local currencies - Non-GAAP EBIT of CHF 619.3 million, up 19% in local
currencies - 2011 US GAAP EPS of CHF 3.22, up 27%
ALLSCHWIL/BASEL, SWITZERLAND - 17 February 2011 - Actelion Ltd (SIX: ATLN) today
announced financial results for the full year 2010.
In CHF Million | Results | Results | % Variance | % Variance
(except for per share data) | FY 2010 | FY 2009 | |
| | | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Total net revenues | 1,929.0 | 1,772.6 | 9 | 13
-----------------------------+---------+---------+------------+------------
Product sales | 1,826.3 | 1,698.0 | 8 | 12
-----------------------------+---------+---------+------------+------------
US GAAP EBIT | 457.3 | 339.4 | 35 | 50
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 619.3 | 567.9 | 9 | 19
-----------------------------+---------+---------+------------+------------
US GAAP EPS (fully diluted) | 3.22 | 2.53 | 27 | 42
-----------------------------+---------+---------+------------+------------
| | | |
| | | |
As of 31 December 2010, Actelion had cash and cash equivalents of CHF 1.4
billion. In addition, Actelion holds 10.5 million treasury shares.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented:
"Actelion's financial performance in 2010 is impressive, given the challenging
health care environment and the ever-strengthening Swiss Franc. For 10 years in
a row, we have been able to grow both our revenues and Non-GAAP EBIT, thus
generating significant value for our shareholders."
Jean-Paul Clozel continued: "Despite the discontinuation of two late-stage
compounds in the last twelve month, our clinical pipeline remains very
promising. In short order, we expect to obtain Phase III data for macitentan, a
landmark study evaluating for the first time in a controlled fashion the long-
term effects of an oral agent in PAH. With the addition of selexipag, we are
well positioned to further develop our PAH franchise. In addition, we are also
evaluating how these two agents could treat other forms of pulmonary
hypertension."
Jean-Paul Clozel added: "In the course of this year, we will also obtain data
from four mid-stage compounds. I am especially looking forward to the results
from our ponesimod Phase IIb study expected this summer that will help us to
select the appropriate dose for the planned Phase III program in Multiple
Sclerosis. Consistent with our strategy, we will also carefully consider
partnerships for some of our compounds, so as to maximize value while managing
risk."
Jean-Paul Clozel continued: "Actelion today is a global company with a strong
business performance and a promising, risk-balanced clinical pipeline. Based on
these assets, I believe that Actelion is well positioned for mid to long-term
above-average shareholder value creation, especially once we transfer - in the
space of three to five years - the market from Tracleer to macitentan by
leveraging our well established PAH infrastructure."
Jean-Paul Clozel concluded: "Given our confidence in the long-term performance
of Actelion, the Board of Directors has decided to ask shareholder approval for
an annual dividend payment. At the Annual General Meeting of 5 May 2011, the
Board of Directors will propose the payment of a dividend in form of repayment
of capital contribution reserves of CHF 0.80 per share."
Andrew J. Oakley, Chief Financial Officer of Actelion commented: "I am pleased
to report a solid financial performance with 619 million Swiss francs in Non-
GAAP EBIT. We benefited from higher than usual contract revenues, but also faced
increasing legal costs related to a lawsuit in the United States, that went to
trial in early February 2011. Importantly, we also made significant investments
in our global business infrastructure and in programs to increase operational
efficacy in order to drive drive further margin expansion in 2011."
Andrew J. Oakley continued: "Overall, Actelion has continued in 2010 to
successfully manage its bottom-line, with in local currency terms Non-GAAP EBIT
growing faster than total net revenues. In 2011, with lower contract revenues,
we will manage our cost base accordingly to continue this bottom-line focus. We
are also continuing to carefully evaluate our cost base to identify further
optimization potential."
Andrew Oakley added: "Unforeseen events excluded, I forecast mid-single digit
product sales growth, in local currencies. In absolute Swiss franc terms, I
expect 2011 operational expenditures to approximately remain at 2010 levels."
Andrew Oakley concluded: "In 2011, I expect Earnings-per-Share to benefit from
the ongoing, up to 800 million Swiss francs, share buyback program. This program
was initiated in November 2010 and is expected to accelerate post the
shareholder meeting in May."
The company will issue formal 2011 operating income and EPS guidance once the
accounting treatment of the remaining deferred revenue from the ongoing GSK
orexin collaboration has been determined.
Revenue performance
Product sales for the full year of 2010 were CHF 1,826.3 million (FY 2009 CHF
1,698.0 million), an increase of 12% in local currencies with, on a constant
currency basis, 45 % coming from the United States, 40 % from Europe and 15 %
from the rest of the world. Product sales growth was almost entirely driven by
patient demand.
2010 full year sales of Tracleer(®) (bosentan) increased by 13 % in local
currencies and reached CHF 1,636.1 million compared to CHF 1,508.0 million for
the same period in 2009.
During the full year of 2010, Ventavis(®) (iloprost) had sales in the United
States of CHF 118.7 million compared to CHF 136.9 million in the full year of
2009. In local currencies, this represents a decrease of 10 %. Q3 2009 was the
last quarter where Ventavis(®) was the only inhaled therapy for PAH.
Sales of Zavesca(®) (miglustat) for the full year of 2010 increased by 37 % in
local currencies to reach CHF 68.7 million compared to CHF 53.1 million during
2009.
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, is proceeding
well, in line with our expectation. Sales of this product for the full year
2010 amounted to CHF 2.8 million.
Otto Schwarz, President of Business Operations of Actelion commented: "In 2010,
next to further expanding Tracleer sales, Actelion also expanded its portfolio
of marketed products, adding Veletri. Tracleer and Zavesca grew in all markets
worldwide, highlighting the demand for innovative therapies in PAH as well as in
Niemann-Pick Type C, with Zavesca available in this indication in many markets
outside the United States."
Otto Schwarz concluded: "With a strong global infrastructure and the appropriate
human resources in place, I expect that we can grow our 2011 product sales with
the same or slightly lower cost base than in 2010. Our continuous commitment in
the PAH marketplace will also provide us with the necessary brand recognition
and customer relationships to successfully introduce new PAH medicines, starting
with Veletri outside of the United States."
In all applicable markets, Actelion is undertaking the necessary efforts to
obtain prolongation of commercial exclusivity for.Tracleer®. In the European
Union, a Pediatric Investigational Plan has been agreed with the EU Health
Authority. Similar procedures are also ongoing in the United States with the US
Health Authority FDA.
Contract revenues for the full year of 2010 were CHF 102.6 million compared to
CHF 74.6 million in the full year of 2009, an increase of 38 % as the company
recognized the remainder of the milestone payment received from the Roche S1P(1)
collaboration.
Operating expenses
Total operating expenses for the full year of 2010 were CHF 1,471.7 million
compared to CHF 1,433.2 million for 2009, an increase of 3 %. The increase was
driven by ongoing investments into both Research and Development as well as to
further expand the use of our marketed products. As a reminder, 2009 operating
expenses included a litigation settlement of CHF 93.7 million.
Research and Development (R&D) expenses in the full year of 2010 were CHF 484.3
million compared to CHF 464.1 million in the full year of 2009. Non-GAAP R&D
expenses for the full year of 2010, which excludes stock-based compensation
expense and amortization and depreciation, were CHF 428.7 million compared to
CHF 417.5 million in the full year of 2009.
Selling, General and Administrative expenses (SG&A) for the full year of 2010
were CHF 744.1 million compared to CHF 645.5 million in the full year of 2009.
Non-GAAP SG&A expenses for the full year of 2010, which excludes stock-based
compensation expense and amortization and depreciation, were CHF 680.6 million
compared to CHF 593.5 million in the full year of 2009.
Operating income
Operating income for the full year of 2010 was CHF 457.3 million compared to CHF
339.4 million for the same period in 2009, an increase of 50% in local
currencies.
In order to better compare the company's underlying performance, Actelion
continues to report Non-GAAP EBIT, which excludes employee stock options,
amortization and depreciation as well as other one-off elements that distort
comparison. Non-GAAP EBIT for the full year 2010 was CHF 619.3 million, an
increase of 19 % in local currencies compared to the same period last year.
Net income
Net income for 2010 amounted to CHF 390.6 million compared to CHF 311.3 million
during the full year of 2009, an increase of 25%.
Net income for the period includes interest income of CHF 3.2 million, interest
expense of CHF 2.7 million, amortization of debt discount of CHF 18.7 million,
other financial income of CHF 1.7 million as well as an income tax expense of
CHF 50.3 million. The tax rate for the full year 2010 was 11.4 %.
US GAAP earnings per share on a fully diluted basis in the full year of 2010
increased by 27 % to CHF 3.22 compared to the same period a year ago. Non-GAAP
earnings per share on a fully diluted basis increased by 4 % to CHF 4.54.
Legal update
In 2008, a lawsuit was filed by Asahi Kasei 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 defending itself in ongoing litigation.
In September 2010, the company reported that that its fully owned US subsidiary
Actelion Pharmaceuticals US, Inc. has received a subpoena from the United States
Attorney's Office for the Northern District of California, requesting documents
relating, among others, to marketing and sales practices of Tracleer® in the
United States. The corresponding investigation is ongoing.
In Canada, Actelion is responding to a Notice of Allegation in connection with
an attempt by a third party to come to market with a generic ahead of expiry of
Canadian patent(s) for Tracleer® in June 2012. Actelion is also fully prepared
to defend its intellectual property in all markets worldwide. Bosentan is
patent-protected in the United States until November 2015 and until early 2017
in Europe.
Clinical Development
Actelion's pipeline currently has ten compounds in clinical development as well
as around 30 projects across the spectrum of the drug discovery process.
Actelion is currently pursuing three ongoing Phase III programs:
Macitentan in pulmonary arterial hypertension
Macitentan is investigated in a Phase III study, SERAPHIN, designed to evaluate
the efficacy and safety of this highly potent, tissue-targeting, endothelin
receptor antagonist. The primary endpoint is morbidity and all-cause mortality
in patients with symptomatic PAH.
Global enrollment was completed in December 2009 with more than 700 patients
included in the trial. The study is event-driven and, based on the progress
observed, results are expected to become available late 2011 or early in 2012.
Selexipag in pulmonary arterial hypertension
Selexipag is investigated in a Phase III study, GRIPHON, designed to evaluate
the efficacy and safety of this first-in-class, orally available, selective IP
receptor agonist in patients with pulmonary arterial hypertension.
Global enrollment is ongoing and early estimates of results' availability
indicate 2013, but as an event-driven study timelines are subject to change.
Olesoxime in amyotrophic lateral sclerosis
In July 2010, Actelion and Trophos entered into a binding agreement whereby
Actelion obtained an exclusive option to acquire privately-held Trophos SA, a
clinical-stage pharmaceutical company. The decision on whether Actelion will
exercise the option to acquire Trophos will be made upon completion of the
ongoing pivotal Phase III study with olesoxime, expected by the end of 2011.
Olesoxime is investigated in a Phase III study designed to evaluate the efficacy
and safety of this mitochondrial pore modulator in patients with amyotrophic
lateral sclerosis (ALS, often referred to as Lou Gehrig's disease) who are
receiving standard of care.
Enrollment was completed in the first quarter of 2010 with a total of 512
patients. The primary endpoint of the study is the overall 18-month survival
rate, therefore study results are expected to become available at the end of
2011.
The mid-stage clinical development programs include:
Ponesimod in multiple sclerosis and psoriasis
Actelion's selective S1P(1) receptor agonist, International Nonproprietary Name
ponesimod, is currently in development as an immunomodulator with the potential
for once-a-day oral dosing for multiple autoimmune disorders.
Ponesimod is investigated in a dose-response study in patients with relapsing-
remitting multiple sclerosis. The study is designed to evaluate the efficacy,
safety, and tolerability of three doses administered for 24 weeks. Enrollment
has concluded with a total of 464 patients and results are expected in the
second half of 2011.
Ponesimod is also investigated in a dose-finding study in patients with moderate
to severe chronic plaque psoriasis. The study is designed to evaluate the
efficacy, safety, and tolerability of two doses of this compound administered
for up to 28 weeks. Enrollment commenced in the fourth quarter of 2010 and the
study is estimated to enroll 320 patients.
Actelion's CRTH2 receptor antagonist in asthma and allergic rhinitis
Actelion's CRTH2 receptor antagonist blocks the effects of prostaglandin D2
(PGD(2)) in inflammation and, as a consequence, the amplification and
maintenance of allergic reactions.
Phase II dose-ranging studies in both asthma and allergic rhinitis were
initiated in the fourth quarter of 2010. The clinical study in allergic rhinitis
has targeted the cedar pollen season in the US and completed enrollment, with
study results expected in Q2 2011.
Actelion's novel antibiotic in Clostridium difficile infection
Actelion's first potent, novel antibiotic is investigated in a Phase II study in
patients with Clostridium difficile infection (CDI). The study is designed to
investigate the efficacy, safety and tolerability profile of three doses of drug
in an estimated 92 patients. Global enrollment commenced in the fourth quarter
of 2010 and study results are expected in H2 2011.
Macitentan in idiopathic pulmonary fibrosis (IPF)
Actelion is conducting an exploratory Phase II study, MUSIC, with macitentan in
patients with IPF, which completed enrollment at the end of June 2010, with 178
patients. Patients are followed for 1 year and therefore study results are
expected in the second half of 2011.
The earlier-stage clinical development programs include:
Miglustat in cystic fibrosis
Actelion is in the process of initiating a Phase II clinical study with
miglustat in cystic fibrosis. This exploratory study will investigate the effect
of miglustat on the nasal potential difference.
Cardiovascular compound
Towards the end of 2010, Actelion initiated a proof-of-concept study with its
novel cardiovascular compound in essential hypertension.
S1P(1) receptor agonist follow-up
Actelion is currently evaluating a second selective S1P(1) receptor agonist in
Phase I.
Talent growth
At the end of 2010, Actelion employed 2,441 employees worldwide, an increase of
seven percent (or 170 positions) to the end of 2009. Of those more than 1,000
are located at the corporate headquarters in Switzerland.
Annual Report
Full details on the progress made in 2010 are available in Actelion's 2010
Annual Report, available from www.actelion.com - "Our company"-"Annual Report"
NOTE TO THE SHAREHOLDERS:
The Annual General Meeting of Shareholders approving the Business Report of the
year ending 31 December 2010 will be held on 5 May 2011.
Shareholders holding more than CHF 1,000,000 nominal value of shares (i.e.
2,000,000 shares at nominal value of CHF 0.50), being entitled to add items to
the agenda of the general meeting of shareholders, are invited to send in
proposals, if any, for the Annual General Meeting of Shareholders on 5 May 2011
to Actelion Ltd, attention Corporate Secretary, Gewerbestrasse 16, CH-4123
Allschwil, to arrive no later than 17 March 2011. Any proposal received after
the given deadline will be disregarded.
In order to attend and vote at the Annual General Meeting of Shareholders,
shareholders must be registered in the Company's shareholders register by 28
April 2011 at the latest.
Upcoming events
* Q1 2011 reporting on 19 April 2011
* Actelion will hold its Annual General Meeting on 05 May 2011
###
For Documentation Purposes
Full Financial Statement:
The full financial statement for the full year of 2010 can be found as a PDF
attached to the media release. It is also available on www.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 FY2010
In CHF Million | |
| FY'10 | FY'09
| |
--------------------------------+--------+--------
Non-GAAP EBIT | 619.3 | 567.9
--------------------------------+--------+--------
Stock option expenses | (83.2) | (70.8)
--------------------------------+--------+--------
Amortization and depreciation | (78.8) | (64.0)
--------------------------------+--------+--------
Litigation settlement | - | (93.7)
--------------------------------+--------+--------
US GAAP EBIT | 457.3 | 339.4
| |
Key Financial Figures for FY 2010
In CHF Million | Results | Results | % Variance | % Variance
| FY 2010 | FY 2009 | |
(except for per share data) | | | In CHF | In LC
-----------------------------+---------+---------+------------+------------
Net Revenues | 1,929.0 | 1,772.6 | 9 | 13
-----------------------------+---------+---------+------------+------------
Non-GAAP OPEX | 1,309.6 | 1,204.7 | 9 | 10
-----------------------------+---------+---------+------------+------------
Non-GAAP EBIT | 619.3 | 567.9 | 9 | 19
-----------------------------+---------+---------+------------+------------
US GAAP EBIT | 457.3 | 339.4 | 35 | 50
-----------------------------+---------+---------+------------+------------
Diluted EPS - US GAAP | 3.22 | 2.53 | 27 | 42
| | | |
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 12.30 hrs, CEST to discuss
the results as well as to provide an update on the development pipeline.
Date/Time:
17 February 2011 12.30 hrs - 14.30 hrs Basel (CET)
11.30 hrs - 13.30 hrs UK (GMT)
06.30 a.m. - 08.30 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 (0)44 580 00 74
UK: +44 (0)203 367 94 58
US: +1 866 907 59 24
Participant's mode:
Listen only
Webcast Access:
Webcast participants should visit the Actelion website http://www.actelion.com/
10-15 minutes before the conference is due to start.
If you experience any access problems go directly to the URL:
http://gaia.world-television.com/actelion/20110217/trunc
Participant's mode:
Listen and watch only
Webcast Replay:
The archived Investor Webcast will be available for replay through
http://www.actelion.com/ approximately 60 minutes after the call has ended.
--- End of Message ---
Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
ISIN: CH0010532478;
Press Release PDF:
http://hugin.info/131801/R/1489892/425464.pdf
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originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE
[HUG#1489892]
Unternehmensinformation / Kurzprofil:
Datum: 17.02.2011 - 07:01 Uhr
Sprache: Deutsch
News-ID 51600
Anzahl Zeichen: 27394
contact information:
Town:
Allschwil
Kategorie:
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