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Thursday 17 February, 2011

Actelion Pharmaceuticals Ltd

Actelion announces Full Year 2010 financial res...




Actelion Pharmaceuticals Ltd /
Actelion announces Full Year 2010 financial results
Processed and transmitted by Thomson Reuters.
The issuer is solely responsible for the content of this announcement. 

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




This announcement is distributed by Thomson Reuters on behalf of 
Thomson Reuters clients. The owner of this announcement warrants that: 
(i) the releases contained herein are protected by copyright and 
    other applicable laws; and 
(ii) they are solely responsible for the content, accuracy and 
     originality of the information contained therein. 
    
Source: Actelion Pharmaceuticals Ltd via Thomson Reuters ONE

[HUG#1489892] 
  



                 

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