Actelion announces 9-month financial results 2009

Corporate news announcement processed and transmitted by Hugin AS.
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announcement.
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Total net revenues of CHF 1,302.5 million, up 22 percent compared to
the first nine months 2008 - Tracleer® sales of CHF 1,114.7 million,
up 19 percent in local currencies - Cash EBIT of CHF 462.0 million,
up 33 percent in local currencies - FY 2009 results expected at upper
end of guidance range - Positive 2010 growth outlook - Final Phase
III study results with bosentan and clazosentan in the months ahead

ALLSCHWIL/BASEL, SWITZERLAND - 20 October 2009 - Actelion Ltd (SIX:
ATLN) today announced its financial results for the first nine months
of 2009. With total net revenues for the first nine months of 2009 of
CHF 1,302.5 million (9M 2008: CHF 1,069.6 m) and operating expenses
of CHF 939.3 million (9M 2008: CHF 794.4 m), the company reported an
operating profit of CHF 363.2 million (9M 2008: CHF 275.2 m).

To better measure and compare operating performance over time,
Actelion continues to report non-US GAAP Cash EBIT (Operating Income
excluding charges such as In-Process R&D, charges related to employee
stock options under FAS 123R as well as non-cash depreciation and
amortization charges). For the first nine months of 2009, Actelion
reported a Cash EBIT of CHF 462.0 million, an increase of 30 percent
compared to the same period in 2008. In local currencies, Cash EBIT
increased by 33 percent. Adjusted (non-US GAAP) diluted earnings per
share for the first nine months of 2009 were CHF 3.48, compared to
CHF 2.53 during the same period last year.

On a US GAAP basis, net profit for the first nine months of 2009 was
CHF 326.9 million (9M 2008: CHF 227.4 m). Fully diluted earnings per
share (EPS) on a US GAAP basis for the same period were CHF 2.66,
compared to CHF 1.84 for the first nine months of 2008.

Jean-Paul Clozel, M.D. and Chief Executive Officer commented:
"Actelion continues to execute in-line with its strategy to create
long-term value for patients. Our franchise in pulmonary arterial
hypertension will ensure profitable growth going forward. With two
additional promising PAH compounds in advanced clinical development
which include macitentan and our partnership with Nippon Shinyaku to
develop the PGI2 receptor agonist, we intend to remain on the
forefront of PAH research and therapy."

Andrew J. Oakley, Chief Financial Officer commented: "In the first
nine months of 2009, Actelion's base business is continuing to
perform strongly, despite an adverse currency environment that
especially impacted Q3 performance as expressed in our reporting
currency, the Swiss Franc. In July of this year, Actelion upgraded
guidance for FY 2009 of both top-line and Cash EBIT growth between 16
and 19 percent in local currencies. Today, I can confirm guidance and
I forecast that we will very likely be towards the upper end of the
ranges given."

Andrew J. Oakley concluded: "Unforeseen events excluded, Actelion's
outlook for 2010 continues to be positive. I am confident that
top-line growth next year will be in the low-double digit range in
local currencies, with commercial leverage allowing for both,
continued strong cash operating margins and above average investment
in innovative growth opportunities."

Financial result overview - Table 9M 2009 vs. 9M 2008

In CHF thousands Result 9M 2009 Result 9M Variance %
2008

Net Revenues 1,302,541 1,069,620 232,921 22

Operating Expenses 939,297 794,424 144,873 18

Operating Income 363,244 275,196 88,048 32

Cash EBIT 462,008 355,643 106,365 30

Net Income* 326,902 227,369 99,533 44

Diluted EPS in CHF* 2.66 1.84 0.82 45

No of shares in 122,743 123,431
calculation

* 2006 convertible bond reclassification according to adoption of FSP
APB 14-1 - comparative period adjusted.

The full financial statements can be found on
http://www.actelion.com.

Continued growth of total net revenues
During the first nine months of 2009, Actelion's total net revenues
increased by 22 percent to CHF 1,302.5 million (9M 2008: CHF 1,069.6
m). In local currencies, total net revenues increased by 23 percent
compared to the first nine months of 2008.

Contract revenues for the first nine months of 2009 amounted to CHF
47.9 million (9M 2008: CHF 29.2 m).

Product sales
During the first nine months of 2009, Tracleer® (bosentan) sales were
CHF1,114.7 million (9M 2008: CHF 945.8 m). In local currencies, this
represents an increase of 19 percent compared to the same period last
year.

In early July, the European Commission approved the pediatric
dispersible formulation of Tracleer® for the treatment of pulmonary
arterial hypertension (PAH) in children from two years of age. This
approval makes Tracleer® the only PAH therapy with an approved
pediatric formulation.

In early August, the U.S. Food and Drug Administration (FDA) approved
the company's supplemental New Drug Application (sNDA) for Tracleer®
to treat patients with mildly symptomatic WHO Functional Class II (FC
II) pulmonary arterial hypertension (PAH). The U.S. FDA has also
approved Actelion's Risk Evaluation and Mitigation Strategy (REMS)
for Tracleer®.

At the end of September 2009, Tracleer® was commercially available in
over 50 countries worldwide, including all major pharmaceutical
markets.

Ventavis® (iloprost) sales amounted to CHF 101.6 million for the
first nine months of 2009
(9M 2008: CHF 64.5 m). This represents an increase of 50 percent in
US Dollars. The ongoing strong performance of Ventavis® is most
likely to trigger a one-off performance milestone payment to Bayer
Schering Pharma in the near future. Accordingly, Actelion has in the
third quarter accrued this forthcoming USD 10 million payment under
cost of goods sold (COGS).

In early August 2009, the FDA approved a new 20 microgram per
milliliter (mcg/ml) formulation of Ventavis® as a therapy for New
York Heart Association Class III and IV PAH. This new increased 20
mcg/ml strength formulation will deliver the same dose in half the
volume which is expected to reduce inhalation time and further
support patient compliance.

The approval was based on the submission of technical data showing
that the new formulation did not alter the functional characteristics
of the delivery system or the emitted dose to the patient. A clinical
program to evaluate the use of a higher-powered disk for the delivery
device is ongoing.

Otto Schwarz, President Business Operations, commented: "Sales growth
remains strong this year driven by Tracleer®, and our outreach
efforts to further expand usage in early-stage patients based on the
broadened US product label will sustain Tracleer® growth going
forward. With the US approval of the 20 mcg/ml Ventavis® solution and
the related reduction in inhalation time, we have also strengthened
the competitive profile of Ventavis®."

Efforts are ongoing to further strengthen our PAH franchise with the
forthcoming market introduction of an improved, thermostable
formulation of epoprostenol sodium for the intravenous treatment of
PAH. This medication was acquired from privately-held GeneraMedix
Inc. in the first half of 2009.

The drug was approved in June 2008 in the United States for the
long-term intravenous treatment of primary pulmonary hypertension and
pulmonary hypertension associated with the scleroderma spectrum of
disease in NYHA Class III and Class IV patients who do not respond
adequately to conventional therapy. Outside the United States,
Actelion expects to initiate regulatory activities for this product,
designed to improve ease of use and patient convenience.

In the first nine months of 2009, Zavesca® (miglustat) sales were CHF
38.3 million (9M 2008: CHF 30.1 m). In local currencies, Zavesca®
sales increased by 33 percent. Zavesca® is commercially available in
over 35 countries including the United States and most European
markets for the treatment of adult patients with mild to moderate
type I Gaucher disease for whom enzyme replacement therapy (ERT) is
not a therapeutic option.

Actelion continues its commitment to patients suffering from type 1
Gaucher disease, not only by continuing its educational efforts in
the field but also by conducting additional clinical studies.
Actelion is following up on the potential use of Zavesca® after a
switch from enzyme replacement therapy by conducting a long-term
MAINTENANCE study. This two-year study was fully enrolled with 42
patients in June 2008. Study results are expected in H2 2010.

In early September 2009, Actelion provided updated information to
US-based Healthcare Professionals who treat type 1 Gaucher patients
regarding the potential use of Zavesca® (miglustat) to minimize the
impact of the supply shortage of imiglucerase (produced and marketed
by Genzyme Corporation under the brand name Cerezyme®).

In January 2009, Zavesca® received approval in the European Union for
the treatment of progressive neurological manifestations in adult
patients and pediatric patients with Niemann-Pick type C disease
(NP-C). Zavesca® is the first treatment to be approved for patients
with Niemann-Pick type C disease, a very rare and devastating
neurodegenerative genetic disorder affecting both children and
adults. The market introduction commenced in late Q2 2009 in selected
European markets.

In the United States, following a constructive pre-NDA (New Drug
Application) meeting with the FDA in H1 2009, Actelion is currently
in the process of filing a supplemental NDA for miglustat (Zavesca®)
in NP-C.

Otto Schwarz concluded: "I am pleased to observe a favorable market
reception for Zavesca® in NPC, resulting in a strong
quarter-on-quarter 32 percent growth in local currencies."

Operating expenses
During the first nine months of 2009, operating expenses were CHF
939.3 million (9M 2008: CHF 794.4 m).

During the same period, research and development expenses increased
by 15 percent to CHF 318.9 million (9M 2008: CHF 277.6 m). Nine-month
2008 operating expenses included a milestone payment related to the
PGI2 receptor agonist in-licensed from Nippon Shinyaku. Excluding
this payment, R&D expenses increased by 29 percent year on year.

Selling, general and administrative expenses for the first nine
months of 2009 amounted to CHF 449.5 million (9M 2008: CHF 387.6 m),
an increase of 16 percent.

Research and Development
Actelion's pipeline now has 10 compounds in clinical development as
well as more than 25 active projects in drug discovery.

Jean-Paul Clozel added: "Since Actelion was founded in late 1997, we
have created a highly productive in-house research and development
organization, which results in a broad and promising preclinical and
clinical pipeline. To further advance organic value creation, we
continue to partner with industry leaders such as Glaxo-Smith Kline,
Merck and Roche. I am pleased that we are making progress in all
three collaborations, working with fully dedicated partners that
share our commitment to innovation and changing patient lives."

Jean-Paul Clozel continued: "It is exactly the same commitment that
drives our in-licensing efforts, where we continue to evaluate
multiple promising product opportunities on an ongoing basis to
further leverage our existing global infrastructure and expertise. We
have done so successfully in the past with Zavesca® and Ventavis®."

There are four compounds in Phase III development, with a fifth
expected to be initiated before year-end 2009. In brief, they are:

- Almorexant in primary insomnia: The first Phase III study,
part of the RESTORA program, is on schedule to report top-line
results before the end of 2009. RESTORA 1 is a pivotal study designed
to evaluate safety and efficacy of almorexant in patients diagnosed
with primary insomnia. The 700-patient double-blind,
placebo-controlled, two-dose, four-arm study includes a reference arm
with zolpidem, an approved treatment for insomnia.

- Bosentan (Tracleer®) in IPF: This 616 patient,
multicenter, double-blind, randomized, placebo-controlled, parallel
group, event-driven morbidity/mortality study (BUILD-3) is evaluating
the safety and efficacy of bosentan 125mg b.i.d. in patients
diagnosed with idiopathic pulmonary fibrosis. Top-line results are
expected in early 2010.

- Clazosentan in aSAH: The Phase III study CONSCIOUS-2
(Clazosentan to Overcome Neurological iSCHemia and Infarct OccUrring
after Subarachnoid hemorrhage) evaluates efficacy and safety of
Clazosentan (5mg/h intravenously for 14 days) versus placebo in 1,146
patients post aSAH treated by surgical clipping of the aneurysm. The
primary endpoint of the study is all-cause mortality and
vasospasm-related morbidity, which includes vasospasm-related
neurological deterioration, vasospasm-related new brain infarcts and
initiation of vasospasm-related rescue therapy. CONSCIOUS-2 results
are expected to become available by mid-year 2010. If successful,
Actelion will approach health authorities for filing. Enrollment is
ongoing in another Phase III study with clazosentan, CONSCIOUS-3.
This 1,500 patient study evaluates the efficacy and safety of two
doses (5 or 15 mg/h) of clazosentan versus placebo in patients
post-aSAH treated by endovascular coiling. The primary endpoint is
identical to that of CONSCIOUS 2.

- Macitentan in PAH: The 700 patient multicenter,
double-blind, randomized, placebo-controlled, parallel group,
event-driven pivotal SERAPHIN program is evaluating safety and
efficacy of this highly potent tissue-targeting endothelin receptor
antagonist through the primary endpoint of morbidity and all-cause
mortality in patients with symptomatic PAH. Study results expected
before year-end 2012.

- Actelion's PGI2 receptor agonist in PAH: Following a
successful Phase IIa study with this first-in-class orally active
non-prostanoid PGI2 receptor agonist, Actelion is currently
finalizing the design for a Phase III program with a
morbidity/mortality endpoint. Program initiation is expected before
year-end.

A comprehensive update on these and all other clinical programs can
be found in the H1 2009 media release, issued on 21 July 2009.

In early October 2009, progress was made with Actelion's selective
S1P1 (Sphingosine-1-phosphate) receptor agonist as the compound
entered into a Phase IIb dose-finding study in patients suffering
from multiple sclerosis. This triggered a milestone payment of USD 20
million from the S1P1-alliance partner Roche to Actelion.

Currently, Actelion and Roche have started to review the data of the
recently concluded Phase IIa proof-of-concept study with this
selective S1P1 agonist in psoriasis. Once data analysis has
concluded, the two companies will make further development decisions
for this agent targeting multiple autoimmune disorders.

Jean-Paul Clozel concluded: "In the months to come, I am looking
forward to reporting clinical data from three Phase III programs:
almorexant in primary insomnia, bosentan in idiopathic pulmonary
fibrosis and clazosentan in non-traumatic subarachnoid hemorrhage."

Operating profit
Actelion's operating profit for the first nine months of 2009 was CHF
363.2 million (9M 2008: CHF 275.2 m). Cash EBIT for the same period
amounted to CHF 462.0 million (9M 2008: CHF 355.6 m).

Net Profit
In the first nine months of 2009, the net profit of CHF 326.9 million
(9M 2008: CHF 227.4 m) includes interest income of CHF 3.6 million,
interest expense of CHF 4.8 million, non-cash interest and
amortization charges on the Convertible Bond of CHF 13.3 million,
foreign currency gains of CHF 15.3 million and an income tax expense
of CHF 37.1 million.

Cash and cash flow
During the first nine months of 2009, Actelion generated net cash
flow from operations of CHF 300.9 million (9M 2008: CHF 410.7 m). As
of 30 September 2009, total liquid funds (excluding 8.6 million
treasury shares) amounted to CHF 1.3 billion.

For documentation purposes - table Q3 2009 vs. Q2 2009

In CHF thousands Result Result Variance %
Q3 2009 Q2 2009

Net revenues 447,302 449,626 (2,324) (1)

Operating Expenses 326,934 328,381 (1,447) 0

- Research and Development 109,318 113,737 (4,419) (4)

- Selling, General and Admin. 149,914 160,758 (10,844) (7)

Operating Income 120,368 121,245 (877) (1)

Cash EBIT 157,161 158,308 (1,147) (1)

Net Income 108,462 116,221 (7,759) (7)

Diluted EPS in CHF 0.88 0.95 (0.07) (7)

No of shares in calculation 123,547 122,033

Upcoming Corporate Events

Before Year-End 2009 - RESTORA-1 in primary insomnia
Q1 2010 - BUILD-3 in IPF
Thursday, 18 February, 2010 - Full Year Results 2009
Thursday, 22 April, 2010 - Q1 Results 2010
Tuesday, 4 May, 2010 - AGM 2010
Mid-2010 - CONSCIOUS-2 in clipped aSAH
Thursday, 22 July, 2010 - Half Year Results 2010
Thursday, 21 October, 2010 - Q3 Results 2010

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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 2'200 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
http://www.actelion.com

Conference Call
Actelion will host an Investor Conference Call / Webcast as follows:
Date/Time:

20 October 2009 15.30 hrs - 16.30 hrs Basel (CEST)
14.30 hrs - 15.30 hrs U.K. (BST)
09.30 a.m. - 10.30 a.m. U.S. (EDT)

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
U.K.: +44 203 147 47 53
U.S.: +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 website for further
details 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/20091020/trunc

Webcast Replay:
The archived Investor Webcast will be available for replay through
http://www.actelion.com/ approximately 60 minutes after the call has
ended.

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil
Switzerland

WKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP,
SMIM, SPI, SPIEX;
Listed: Main Market in SIX Swiss Exchange;
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