Actelion announces Half Year financial results 2009

Jul 21, 2009 (Hugin via COMTEX) --
ALIOF | Quote | Chart | News | PowerRating -- Corporate news announcement processed and transmitted by Hugin AS.
The issuer is solely responsible for the content of this
announcement.
----------------------------------------------------------------------
--------------
Total net revenues of CHF 855.2 million, up 27 percent compared to H1
2008 - Tracleer(R) sales of CHF 739.3 million, up 23 percent in local
currencies - Cash EBIT of CHF 304.8 million - Upgraded top and bottom
line guidance - Key Phase III results reporting starting in Q4 2009
with almorexant in RESTORA-1 - BUILD-3 with bosentan in IPF in early
2010 - clazosentan in aSAH by-mid 2010

ALLSCHWIL/BASEL, SWITZERLAND - 21 July 2009 - Actelion Ltd (SIX:
ATLN) today announced its financial results for the first half of
2009. With total net revenues for the first six months of 2009 of CHF
855.2 million (H1 2008: CHF 676.0 m) and operating expenses of CHF
612.4 million (H1 2008: CHF 538.8 m), the company reported an
operating profit of CHF 242.9 million (H1 2008: CHF 137.2 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 six months of 2009, Actelion
achieved a Cash EBIT of CHF 304.8 million, an increase of 60 percent
compared to the same period in 2008. In local currencies, Cash EBIT
increased by 61 percent. Adjusted (non-US GAAP) diluted earnings per
share for the first six months of 2009 were CHF 2.31, compared to CHF
1.42 during the same period last year.

On a US GAAP basis, net profit for the first half of 2009 was CHF
218.4 million (H1 2008: CHF 119.5 m). Starting on 1 January 2009, due
to the adoption of FSP APB 14-1, the company incurred total non-cash
charges of CHF 8.8 million related to its 2006 convertible bond. The
comparative periods have been adjusted.

Fully diluted earnings per share (EPS) on a US GAAP basis for the
first six months of 2009 were CHF 1.79, compared to CHF 0.97 for the
same period in 2008.

Jean-Paul Clozel, M.D. and Chief Executive Officer commented: "I am
very pleased with our performance in the first six months of 2009.
Today, we offer innovative products for patients. We are making
significant headway towards obtaining clinical data in the months
ahead that might turn development compounds into tomorrow's
pharmaceutical options."

Jean-Paul Clozel concluded: "I am especially pleased with the
promising results of our PGI2 receptor agonist that allows for
accelerated development as an oral agent stimulating the prostacyclin
pathway. We have also entered a novel anti-infective into clinical
development, thereby demonstrating our commitment to bringing our
platform approach in research to fruition in multiple areas of high
unmet medical demand."

Andrew J. Oakley, Chief Financial Officer commented: "Again, Actelion
is reporting strong top and bottom line growth. We grow top line
revenues as a result of the innovation inherent in our products and
the way we appropriately communicate those benefits to treating
physicians. We grow our bottom line because we make the appropriate
investments at the right time to further advance our rapidly
expanding and maturing research and development pipeline."

Andrew J. Oakley added: "Considering the operating performance in the
first half of 2009, I am confident that Actelion will exceed initial
guidance. Hence, Actelion now expects, unforeseen events excluded,
that both total net revenues and Cash EBIT - in local currencies -
will increase between 16 and 19 percent for the full year of 2009
(initial 2009 revenue guidance: 12 to 15 percent; initial Cash EBIT:
10 to 12 percent).

Financial result overview - Table H1 2009 vs. H1 2008

In CHF thousands Result H1 Result H1 Variance %
2009 2008

Net Revenues 855,239 675,982 179,257 27
Operating Expenses 612,363 538,766 73,597 14
Operating Income 242,876 137,216 105,660 77
Cash EBIT 304,847 190,791 114,056 60
Net Income 218,440 119,479 98,961 83
Diluted EPS in CHF 1.79 0.97 0.82 85
No of shares in 122,340 123,512
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 half of 2009, Actelion's total net revenues
increased by 27 percent to CHF 855.2 million (H1 2008: CHF 676.0 m).
In local currencies, total net revenues increased by 26 percent
compared to the first half of 2008.

Contract revenues for the first six months of 2009 amounted to CHF
32.0 million (H1 2008: CHF 13.2 m). As a result of our decision to
invest more time in finalizing the design for the remaining
almorexant pivotal studies, Actelion has, as of June 2009, changed
the recognition of the initial CHF 150 million milestone payment
received from Glaxo Smith Kline. The recognition period has been
extended by 9 months until the end of 2012. Accordingly, Actelion
will now recognize CHF 7.9 million per quarter going forward
(previously: CHF 10.0 m in Q1 2009, CHF 9.3 m in Q2 2009).

Product sales
During the six months of 2009, Tracleer(R) (bosentan) sales were CHF
739.3 million (H1 2008: CHF 605.2 m). In local currencies, this
represents an increase of 23 percent compared to the same period last
year.

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

Following the US Food and Drug Administration complete response
letter regarding the Tracleer(R) supplemental New Drug Application in
early March 2009, Actelion has been working closely with the FDA to
agree on the details of the Risk Evaluation and Mitigation System
(REMS). Once the REMS has been agreed, the FDA will then be in a
position to finalize its review of the information submitted for
inclusion of less severe (so-called Functional Class II) PAH patients
to the US product label.

At the end of June 2009, Tracleer(R) was commercially available in over
50 countries worldwide, including all major pharmaceutical markets.

In this reporting period, Tracleer(R) has also seen approvals for
Functional Class II PAH in Canada and Australia. In Croatia, both FC
II and the Digital Ulcer indication have also been added to the
label. Tracleer(R) was also approved in New Zealand for use in PAH
related to congenital heart disease (Eisenmenger's syndrome).
Tracleer also received its first approval in Lebanon for use in FC II
and III as well as Digital Ulcers.

Ventavis(R) (iloprost) sales amounted to CHF 61.5 million for the first
half of 2009
(H1 2008: CHF 37.9 m). This represents an increase of 50 percent in
local currencies.

Otto Schwarz, President Business Operations, commented: "In the first
six months of 2009, sales growth remained strong. While we continue
to record double-digit growth in all major markets worldwide, I am
especially pleased with the performance we observed in Japan, where
sales growth is a direct response to the sales force increase we
undertook between late 2008 and early 2009."

Effective 11 March 2009, Actelion acquired an improved, thermostable
formulation of epoprostenol sodium for the intravenous treatment of
pulmonary arterial hypertension (PAH) from privately-held GeneraMedix
Inc. 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.

In the coming months, upon completion of all required administrative
and other preparatory tasks, Actelion expects to gradually introduce
the improved thermostable formulation of i.v. epoprostenol in the
United States. Outside the United States, Actelion expects to
initiate regulatory activities for this product that is designed to
improve ease of use and patient convenience.

In the first six months of 2009, Zavesca(R) (miglustat) sales were CHF
22.4 million (H1 2008: CHF 19.7 m). In local currencies, Zavesca(R)
sales increased by 19 percent. Zavesca(R) is commercially available in
over 35 countries including the United States and most European
markets. In this reporting period, the New Zealand Health Authorities
approved Zavesca(R) 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(R) 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 January 2009, Zavesca(R) 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(R) 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. Market introduction commenced in late Q2 2009, with the drug
now reimbursed for NP-C in six EU member states.

In the United States, following a constructive pre-NDA (New Drug
Application) meeting with the FDA, Actelion expects to file a
supplemental NDA for miglustat (Zavesca(R)) in
NP-C in H2 2009.

Otto Schwarz concluded: "With Zavesca(R), Actelion has the opportunity
to achieve significant growth in the years ahead, driven by both
increased penetration in the type 1 Gaucher market and by creating a
new market for this orally available substrate therapy in NP-C."

Operating expenses
During the first half of 2009, operating expenses were CHF 612.4
million (H1 2008: CHF 538.8 m).

During the same period, research and development expenses increased
by 4 percent to CHF 209.6 million (H1 2008: CHF 201.2 m). H1 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 23 percent year on year.

Selling, general and administrative expenses for the first six months
of 2009 amounted to CHF 299.6 million (H1 2008: CHF 255.1 m), an
increase of 17 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.

Almorexant in primary insomnia: The first Phase III study, which is
part of the RESTORA program, is on schedule to conclude in the second
half 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.

As a result of the discussions with the FDA, more time in finalizing
the design for the remaining almorexant RESTORA program is required,
extending the program timelines by 9 months. The Actelion/GSK
collaboration now expects to resubmit the clinical protocols to the
FDA to gain a Special Protocol Assessment (SPA) before the end of the
year. Accordingly, these pivotal studies are expected to be initiated
no sooner than early 2010. In the mean time the non-pivotal program
is ongoing.

Bosentan (Tracleer(R)) in IPF: This 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. BUILD-3 enrollment was completed in
October 2008 with 616 patients. The second interim analysis for
BUILD-3 (i.e., 75 % of the primary endpoint events) took place on the
7 May 2009, with the independent Data and Safety Monitoring Board
(DSMB) recommending continuation of the study.

The BUILD-3 study will be closed upon reaching the target 202
confirmed events, which is expected to occur at the end of 2009.
Consequently, Actelion expects top-line results to become available
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 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 is currently enrolling
at centers in over 25 countries in the EU, Canada, Asia, Australia
and New Zealand. At the end of January 2009, Actelion had also
initiated additional clinical centers in the United States.

Blinded review of the overall event rate indicated a lower than
expected event rate. In agreement with the Steering Committee,
Actelion has decided - in order to maintain the statistical power of
the study and as foreseen in the protocol - to add 381 patients to
the initially planned 765 patients. Accordingly, CONSCIOUS-2 results
are now expected to become available by mid-year 2010. If successful,
Actelion will approach health authorities for filing.

A second Phase III study, CONSCIOUS-3, has started enrollment to
evaluate 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, i.e., reduction of the incidence of cerebral
vasospasm-related morbidity and all-cause mortality within six weeks.
CONSCIOUS-3 will enroll at approximately 150 centers from around 30
countries with a target enrollment of 1500 patients.

Macitentan in PAH: The 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. Global enrollment is ongoing, with over 400 patients
already enrolled.

As enrollment is significantly faster than previously expected and
the event rate slightly lower than initially predicted, Actelion has
decided - as foreseen in the protocol - to increase enrollment to 700
patients from the 525 patients originally planned. The company
continues to expect study results to become available before the end
of 2012, as the target date for full enrollment remains unchanged.
SERAPHIN is the largest clinical study in PAH patients and the first
to include, from the beginning, a clearly defined morbidity/mortality
primary endpoint.

Actelion's PGI2 receptor agonist in PAH: Positive data have been
obtained in a Phase IIa study with this first-in-class orally active
non-prostanoid PGI2 receptor agonist. In the 43-patient
placebo-controlled study to assess efficacy, safety and tolerability,
the primary endpoint of pulmonary vascular resistance (PVR) change
from baseline was met with high statistical significance (p<0.01).
The compound was well tolerated.

The study results support advancing this first orally active
non-prostanoid PGI2 receptor into Phase III. This approach was
previously discussed and agreed with the FDA while the study was
ongoing. Actelion will now rapidly approach the FDA to finalize the
design for a Phase III program with a morbidity/mortality endpoint.
Consequently, Actelion expects to initiate this program before
year-end.

Isaac Kobrin, M.D. and Chief Medical Officer commented: "I am pleased
that Actelion has a multitude of innovative agents in various stages
of clinical development. We are making significant progress in
advancing these compounds, always evaluating on how to best provide
physicians with evidence-based medicine. With this in mind, we have
carefully adapted the study size for both clazosentan and macitentan
to further that goal. In the case of almorexant, we are taking the
necessary time to finalize a development approach that satisfies the
development requirements of an innovative compound that might enter
the GP area."

CRTH2 receptor antagonist in asthma: Plans for initiating a Phase II
dose-finding study in asthma are progressing on schedule, following
the positive proof-of-mechanism data obtained in early 2009 and a
pre-IND meeting with the FDA. In the proof-of-mechanism, double-blind
placebo-controlled study, the primary endpoint (FEV1) was met and the
compound was well tolerated. In addition, preclinical studies showed
this compound to inhibit the migration and activation of cell types
centrally involved in allergic inflammation.

Miglustat in Cystic Fibrosis: The recently concluded Phase IIa
proof-of-concept study does not support further clinical development
at this time. However, there is a strong scientific rationale
described in the published literature (Norez C, Antigny F, Noel S,
Vandebrouck C and Becq F. A CF respiratory epithelial cell
chronically treated by miglustat acquires a non-CF like phenotype. Am
J Respir Cell Mol Biol 2009 Jan 2009 (print forthcoming)). Actelion,
therefore, has decided to conduct further preclinical evaluation of
miglustat in CF before making final decisions on the future of the
compound in this indication.

Macitentan in IPF: A pilot clinical development study with this
highly potent tissue-targeting endothelin receptor antagonist in
idiopathic pulmonary fibrosis has commenced enrollment in H1 2009.
The double-blind, randomized, multicenter study will evaluate the
efficacy and safety of macitentan in patients with IPF.

Selective S1P1 receptor agonist in multiple sclerosis: Following a
successful Phase I program, Actelion's first-in-class selective S1P1
receptor agonist partnered with Roche is expected to dose its first
patient in a Phase IIb study in the coming months.

Selective S1P1 receptor agonist in psoriasis: The proof-of-concept
study with 66 patients in psoriasis has completed enrollment in June
2009. Results are expected to become available in the coming months.

Novel anti-infective: In mid-July 2009, Actelion initiated Phase I
with the first novel anti-infective resulting from its platform
approach in research. Anti-Infectives are an important therapeutic
area with high unmet medical demand, given the growing resistance
observed in daily practice with existing classes of compounds.

Martine Clozel, MD and Chief Scientific Officer at Actelion
commented: "Actelion has developed platforms of expertise in families
of molecular targets which allow high productivity in the generation
of innovative compounds potentially addressing a wide range of high
unmet medical needs. I am very pleased to be able to announce today
that our efforts focused on developing potent, novel classes of
antibiotics covering multi-resistant pathogens, with a low propensity
for resistance have resulted in our first anti-infective entering
clinical studies."

Operating profit
Actelion's operating profit for the first half of 2009 was CHF 242.9
million (H1 2008: CHF 137.2 m). Cash EBIT for the same period
amounted to CHF 304.8 million (H1 2008: CHF 190.8 m).

Net Profit
In the first half of 2009, the net profit of CHF 218.4 million (H1
2008: CHF 119.5 m) includes interest income of CHF 2.5 million,
interest expense of CHF 2.5 million, non-cash interest and
amortization charges on the Convertible Bond of CHF 8.8 million,
foreign currency gains of CHF 7.5 million and an income tax expense
of CHF 23.1 million.

Cash and cash flow
During the first half of 2009, Actelion generated net cash flow from
operations of CHF 127.2 million (H1 2008: CHF 141.4 m). As of 30 June
2009, total liquid funds (excluding 7.8 million treasury shares)
amounted to CHF 1.2 billion.

For documentation purposes - table Q2 2009 vs. Q1 2009

In CHF thousands Result Result Variance %
Q2 2009 Q1 2009

Net revenues 449,626 405,613 44,013 11
Operating Expenses 328,381 283,982 44,399 16
- Research and 113,737 95,848 17,889 19
Development
- Selling, General and 160,758 138,831 21,927 16
Admin.
Operating Income 121,245 121,631 (386) 0
Cash EBIT 158,308 146,539 11,769 8
Net Income 116,221 102,143 14,078 14
Diluted EPS in CHF 0.95 0.83 0.12 14
No of shares in 122,033 122,647
calculation

###

Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate
headquarters in Allschwil/Basel, Switzerland. Actelion's first drug
Tracleer(R), an orally available dual endothelin receptor antagonist,
has been approved as a therapy for pulmonary arterial hypertension.
Actelion markets Tracleer(R) 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 2000 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(R) )

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:

21 July 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 52
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/20090721/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.

Upcoming Corporate Events

Tuesday, 20 October, 2009 - Q3 Results 2009
Thursday, 18 February, 2010 - Full Year Results 2009
Thursday, 22 April, 2010 - Q1 Results 2010
Tuesday, 4 May, 2010 - AGM 2010
Thursday, 22 July, 2010 - Half Year Results 2010
Thursday, 21 October, 2010 - Q3 Results 2010

--- End of Message ---

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;

SOURCE: Actelion Pharmaceuticals Ltd

For full details on (ALIOF) ALIOF. (ALIOF) has Short Term PowerRatings at TradingMarkets. Details on (ALIOF) Short Term PowerRatings is available at This Link.