Actelion Pharmaceuticals Ltd : Actelion delivers strong performance in 2012 -
Getting ready for Opsumit launch in 2013
Actelion Pharmaceuticals Ltd / Actelion delivers strong performance in 2012 -
Getting ready for Opsumit launch in 2013 . Processed and transmitted by
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ALLSCHWIL/BASEL, SWITZERLAND - 14 February 2013- Actelion Ltd (SIX: ATLN)
today announced financial results for the full year 2012.
*Positive results for macitentan (Opsumit^®) reported in April - regulatory
dossier submitted to FDA and EMA in Q4 2012
*Strategy for long-term shareholder value creation announced in May 2012
*Solid Tracleer^® sales in a challenging environment, up 1% in volume (down
4% in local currencies)
*Regulatory approvals for improved formulation of Veletri^® in US,
Switzerland and Canada
*Ponesimod in psoriasis and cadazolid in Clostridium difficile associated
diarrhea to move into Phase III during 2013 following successful mid-stage
*Product sales of CHF 1,722.1 million, down 2% in local currencies
*Core earnings of CHF 537.0 million, up 6% in local currencies
*Core EPS of CHF 3.69, up 16% in local currencies
*Strong earnings and cash generation enables a proposed 25% increase in
dividend to CHF 1.00 per share
*CHF 800 million share repurchase program to be completed (remaining CHF
416 million) in 2013
*2013 Guidance: Maintain local currency core earnings at 2012 level
In CHF Million Results Results % Variance % Variance
(except for per share data) FY 2012 FY 2011 In CHF In LC
Product sales 1,722.1 1,713.0 1 (2)
US GAAP Operating income 421.5 12.2 * *
Core earnings (excluding DDP) 537.0 480.6 12 6
US GAAP EPS (fully diluted) 2.57 (1.23) - -
Core EPS (fully diluted) 3.69 3.04 22 16
As of 31 December 2012, Actelion had cash and cash deposits of CHF 1.5 billion
(of which CHF 368.7 million is restricted). In addition, Actelion holds 13.8
million treasury shares.
Jean-Paul Clozel, MD, Chief Executive Officer commented: "2012 was a landmark
year for Actelion. Through the successful trial with macitentan (Opsumit^®)
announced in April, we have demonstrated our ability to innovate at Actelion.
With organizational discipline and a strong commitment to quality, our clear
objective ahead is to translate that innovation into benefits for patients and
long-term value for shareholders. Actelion is now at a very exciting stage in
Andrew Oakley, Chief Financial Officer added: "In 2012, we have achieved the
appropriate balance between attractive shareholder returns, investment in the
business and a strong capital structure. We have delivered significant returns
to shareholders through the continuation of the buyback program and we are
proposing a 25 percent increase in dividend. At the same time we continue with
the right level of investment in R&D. Actelion therefore remains on track to
deliver on the short- to mid-term core earnings guidance announced at the time
of our strategic review."
For 2013, Actelion expects to maintain local currency core earnings at the
2012 level, barring unforeseen events. The company then expects to return to
single-digit core earnings growth in 2014 and double-digit growth by 2015.
Full details on the progress made in 2012 are available in Actelion's 2012
Annual Report, available from www.actelion.com
PRODUCT SALES FOR FY2012
In CHF million Results Results % Variance % Variance
FY 2012 FY 2011 In CHF In LC
Tracleer sales 1,500.2 1,522.1 (2) (4)
Ventavis sales 110.2 106.4 4 (2)
Veletri sales 24.0 14.7 63 53
Zavesca sales 84.7 68.4 24 24
Total Product Sales 1,722.1 1,713.0 1 (2)
2012 was a demanding year for Actelion's products on the market. It was
challenging due to a number of factors beyond the company's control, including
the very difficult pricing environment outside the US and the continued
strength of the Swiss Franc - Actelion's reporting currency. Furthermore, in
the US, the company's pulmonary arterial hypertension (PAH) product portfolio
continues to face significant competition, although here the effects have been
mitigated by price increases across our portfolio.
Despite the difficult market environment, total product sales of CHF 1,722.1
million were achieved. This is marginally lower (2% in local currencies) than
last year's total, reflecting, in particular, the negative pricing environment
in territories outside the US, where revenues declined in spite of solid mid-
to high-single-digit volume growth.
In 2012, the company encountered the first launches of generic versions of
bosentan in Canada. Actelion's dedication to the PAH community has been
rewarded with loyalty, and hence generic erosion of sales of Tracleer® has
been slower than benchmarks would suggest.
The global sales breakdown is consistent with 2011. Japan and emerging PAH
markets such as Mexico, Russia and China continued to deliver very solid
local-currency sales growth. Overall, 41% of sales came from US operations,
37% from Europe, 12% from Japan and 10% from the rest of the world.
NON-GAAP TO US GAAP RECONCILIATION FOR FY2012
In CHF million FY2012 FY 2011
Product sales 1,722.1 1,713.0
Core operating expenses (1,185.1) (1,232.4)
Core earnings excluding impact of DDP 537.0 480.6
Movement in doubtful debt provision 22.6 (43.2)
Contract revenues 6.3 83.1
Stock option expenses (46.6) (84.9)
Amortization and depreciation (81.9) (82.9)
Litigation provision - (340.6)
Auxilium milestone payment (9.1) -
Restructuring charge (6.9) -
US GAAP Operating Income 421.5 12.2
CORE EPS CALCULATION
In CHF million FY2012 FY 2011
Core earnings 537.0 480.6
Non-GAAP financial result (21.4) (44.4)
Adjusted income before tax 515.7 436.2
Tax (79.5) (75.5)
Adjusted net income 436.2 360.7
N^o of shares in calculation 118.1 118.8
Core EPS 3.69 3.04
NOTES TO SHAREHOLDERS:
The Annual General Meeting of Shareholders to approve the Business Report of
the year ending 31 December 2012 will be held on 18 April 2013.
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, to Actelion Ltd, attention Corporate Secretary,
Gewerbestrasse 16, CH-4123 Allschwil, to arrive no later than 8 March 2013.
Any proposal received after the 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 shareholder register by 9
April 2013 at the latest.
oQ1 Financial Results 2013 reporting on 16 April 2013
oAnnual General Meeting of Shareholders on 18 April 2013
oHY Financial Results 2013 reporting on 19 July 2013
NOTES TO EDITORS
CHAIRMAN AND CHIEF EXECUTIVE STATEMENT
CREATING VALUE THROUGH SCIENTIFIC INNOVATION
2012 was a landmark year for Actelion. In April, we announced positive results
for macitentan (Opsumit®), the latest addition to our pulmonary arterial
hypertension (PAH) portfolio. Macitentan - the result of a tailored, in-house
drug discovery process - was evaluated in the largest morbidity/mortality
study ever conducted in PAH. This long-term outcome study, SERAPHIN, which
began in 2007 and lasted over four years, demonstrated that macitentan
provides a significant and clinically relevant reduction in the risk of
morbidity/mortality. This novel and differentiated dual endothelin receptor
antagonist (ERA) is an excellent example of how value in the pharmaceutical
industry is best created through innovation.
Following the announcement of the results of the SERAPHIN study, the
management and Board took immediate steps to shape the future direction of
your company. In May, we announced our strategy for long-term shareholder
value creation, built around three key elements. We are focusing our efforts
on sustaining and growing our PAH franchise in the short-term and on building
a second specialty franchise as a mid-term goal. These two elements will allow
us to deliver on the third element of our strategy - increasing profitability.
By the end of 2012 rapid progress had already been made with its
SUSTAINING GLOBAL LEADERSHIP IN PAH THERAPY
Actelion is sustaining its leadership in the PAH market with its broad range
of products. In 2012, Tracleer^® continued to be the ERA of choice for
prescribing physicians, even in regions with strong competition. Our strategy
of treating PAH with the aim of improving symptoms to, or maintaining patients
at, Functional Class II enabled Tracleer to remain the gold standard in PAH
treatment, with over 44,000 PAH patients currently receiving therapy.
Ventavis^®, which is formulated for optimized inhalation time, continued to be
an important source of revenue for our US operations.
Veletri® is an improved formulation of intravenous epoprostenol. Unlike other
epoprostenol formulations approved for PAH, Veletri has greater stability.
This provides unique benefits, such as a more flexible preparation of the
medication and infusion of the product without the need for constant cooling
with ice-packs. During 2012, Actelion received approval to market a further
improved formulation of Veletri in the US, Switzerland and Canada, with
regulatory reviews advancing in Japan and the EU. Access to these additional
markets will bring further opportunity for growth.
This leading position in the PAH market is now set to continue thanks to our
pipeline compounds. Following the positive study results, the registration
dossier for macitentan was submitted to the US Food & Drug Administration
(FDA), the European Medicines Agency (EMA) and other health authorities during
the fourth quarter of 2012. With the combination of an effective worldwide
commercial organization and this novel and differentiated ERA, Actelion will
enable the medical community to reshape the treatment paradigm for patients
In parallel, Actelion has advanced selexipag, potentially the first oral
prostacyclin-based therapy for the treatment of PAH, which is currently in
Phase III. At the end of 2012, we had enrolled more than 1,000 patients into
the pivotal study. As with our evaluation of macitentan, this outcome study is
designed to demonstrate a reduction in the risk of morbidity/mortality events.
BUILDING AN ADDITIONAL SPECIALTY FRANCHISE
The second part of our strategy for long-term value creation is to build an
additional specialty franchise alongside PAH. We have focused our research and
development (R&D) efforts on orphan and specialty indications, supported by
ongoing business development activities; the aim is to utilize our expertise
to find differentiated commercial assets that a company of our size can
successfully bring to market.
Choosing to concentrate our efforts on orphan and specialty indications will
lead to more targeted R&D spending. Following a portfolio review, those
projects not aligned with this strategy have been discontinued or are being
prepared for partnership or out-licensing.
At the end of 2012, excellent progress was reported for two of Actelion's
mid-stage clinical studies. First we announced positive results with
ponesimod, an S1P modulator, in psoriasis, a chronic and relapsing skin
disease affecting up to 3% of the population worldwide. The findings were
particularly encouraging since this is the first time that this mode of action
has been effective for psoriasis patients. This news was shortly followed by
the positive results for our novel antibiotic, cadazolid, in Clostridium
difficile associated diarrhea (CDAD). The bacterium Clostridium difficile is
the leading cause of hospital acquired diarrhea and CDAD can be severe, even
life-threatening. This is the first time cadazolid has been used to treat
patients and has delivered very encouraging clinical data. Based on the
excellent progress, Actelion has decided to proceed with the development of
both compounds in Phase III, providing the foundation for our mid-term goal of
building an additional specialty franchise.
MAINTAINING AND GROWING PROFITABILITY
In 2012, Actelion delivered core earnings of CHF 537.0 million, an increase of
12% in Swiss Francs or 6% in local currencies (excluding the impact of
provisions for doubtful debts). This result - achieved in spite of a
challenging economic environment - is a direct consequence of our cost-saving
initiative and underscores our commitment to optimize the company's
The cost-saving initiative implemented in the second half of 2012 addressed
several ongoing external challenges, including the continued strength of the
Swiss Franc, increased competition in the US, and the difficult pricing
environment in Europe. In parallel, we adapted the size of our R&D
organization to match our new focus on specialty medicines. Importantly, this
initiative left our commercial capabilities unchanged and will ensure the
availability of sufficient investment capacity to leverage the opportunities
we have created in the field of PAH.
We strongly believe that, thanks to the measures implemented in 2012, your
company is well positioned for sustainable core earnings growth and enhanced
shareholder returns. For 2013, we expect to maintain local currency core
earnings at the 2012 level, barring unforeseen events. We then expect
single-digit core earnings growth in 2014 and double-digit growth by 2015.
Our commitment goes beyond performance forecasts: Actelion's balance sheet,
strong cash generation and the exceptional pipeline newsflow in 2012 gives us
confidence in our future. Therefore the Board will propose a 25% increase in
the dividend payment for your approval at the 2013 Annual General Meeting. In
addition, we will manage capital allocation so as to continue to return value
to our shareholders through timely completion of the CHF 800 million share
repurchase program by the end of 2013.
COMMITMENT TO GROWTH
Since the company was established some fifteen years ago, Actelion has been
committed to discovering innovative drugs that change the lives of patients.
We have demonstrated the benefits of those drugs through innovative clinical
development, laying the foundations for evidence-based medicine. We have also
made our drugs for specialty indications available worldwide.
We are confident in our ability to innovate, and we believe that, through
organizational discipline and a commitment to quality, innovation can be
translated into benefits for patients and long-term value creation for
shareholders. This is an exciting time for the company, and we hope you will
share our enthusiasm as you read about what we have achieved in 2012 and our
plans for the future.
Chairman of the Board of Directors
Chief Executive Officer
The European debt crisis and slower global economic growth continued to impact
the business landscape in 2012. Pressure on government budgets weighed heavily
on healthcare markets around the globe. Additionally, the competitive
environment continued to adversely affect sales in the United States. Amid
these challenges Actelion posted a solid top line performance with benefits
from cost reductions seeing core earnings growing by 6% in local currencies,
thereby delivering significant operational leverage.
Actelion's commercial organization delivered a strong sales performance in
2012, despite intensified price pressure and continued competition. Total
product sales for the full year were CHF 1,722.1 million. This represents an
increase of 1% in Swiss Francs and a decrease of 2% in local currencies.
Contract revenues for 2012 amounted to CHF 6.3 million. In 2011, contract
revenues included the remaining deferred revenue from the terminated orexin
collaboration with GlaxoSmithKline.
Actelion is focusing its resources on commercial efforts and pipeline programs
that have the greatest potential to deliver meaningful benefits for patients.
For 2012, total operating expenses were CHF 1,306.9 million compared to CHF
1,783.9 million during 2011. The main driver of the decrease is the impact in
2011 of the Asahi Kasei litigation award of CHF 340.6 million as well as a
reduction in provisions made for doubtful debts in southern Europe, mainly as
a result of improved cash collection. Expenses in 2012 also included a
restructuring charge of CHF 6.9 million related to the cost saving initiative
executed during the second half of the year.
Cost of sales amounted to CHF 196.3 million, or 11% of sales, unchanged from
the previous reporting period.
Research and development (R&D) expenses increased by 1%, to CHF 460.5 million,
compared to CHF 457.7 million in 2011. These expenses include the USD 10
million milestone payment to Auxilium Pharmaceuticals, Inc. in relation to our
collaboration on XIAFLEX^® in certain territories. The lower R&D expenditure
net of the Auxilium payment is the result of the refocusing of Actelion's
pipeline, announced as part of the company's strategic review in May 2012,
which is expected to continue to reduce R&D expenditure in the coming year.
Selling, general and administration (SG&A) expenses for 2012 amounted to CHF
610.9 million, a decrease of 19% in Swiss Francs and 20% in local currencies.
Part of this decrease can be attributed to the reduction in the allowance for
doubtful debt on receivables in southern Europe.
Core operating expenses (includes cost of sales) for the full year were CHF
1,185. 1 million, a decrease of 5% in local currencies compared to the
previous year. Core operating expenses exclude all charges related to employee
stock options; depreciation and amortization; and one-off items that distort
comparative analysis, such as the legal provision of CHF 340.6 million or the
restructuring charge of CHF 6.9 million and provisions for doubtful debts.
Core R&D expenses amounted to CHF 398.5 million, down 1% compared to the
previous year in local currencies while core SG&A expenses decreased by 9% to
CHF 590.2 million, also in local currencies.
The result of all of the above is a reported operating income of CHF 421.5
million for 2012, compared with CHF 12.2 million in 2011.
Better reflecting the actual operating performance of the business is the core
earnings measure amounting to CHF 537.0 million, an increase of 6% in local
currency terms which represents an 8% improvement in operating margin. Core
earnings exclude movements in doubtful debt provisions and other one-time
items such as the Asahi litigation provision in 2011.
NON-OPERATING RESULTS AND TAXES
Interest income for 2012 amounted to CHF 2.1 million compared to CHF 6.2
million in 2011.
The interest provision on the Asahi litigation award, which accrues at an
annual rate of 10% and is payable only if the appeal is not successful,
amounted to CHF 41.6 million for 2012, compared to CHF 19.7 million during
2011. Interest expense (including issuance costs) on the CHF 235 million bond
was CHF 12.0 million, impairment on financial assets amounted to CHF 0.3
million and other interest expense, relating mostly to deferred consideration
in connection with the acquisition of a new formulation of epoprostenol sodium
with improved thermal stability from GeneraMedix, amounted to CHF 0.5
Other financial expenses for the year amounted to CHF 10.6 million, compared
to CHF 22.9 million in 2011.
Income tax expense for the period under review amounted to CHF 55.2 million,
compared with CHF 77.0 million in 2011. The tax rate for the year is 15.4%
compared to a litigation provision adjusted tax rate of 17.3% for the previous
NET INCOME AND EARNINGS PER SHARE
Net income for the full year of 2012 amounted to CHF 303.2 million compared to
a loss of CHF 146.3 million in 2011.
This translates into fully diluted earnings per share of CHF 2.57. Core
earnings per share were CHF 3.69, an increase of 22%.
BALANCE SHEET AND CASH FLOW
Our cash generation remains strong, enabling us to invest for future growth
and value by funding investment in R&D, while also providing CHF 357.9 million
in net cash distributions to shareholders by way of dividends and share
Cash from operations for the period under review amounted to CHF 572.4
million, compared with CHF 404.9 million in 2011. The company's gross cash
position at 31 December 2012 amounted to CHF 1.5 billion, of which CHF 368.7
million is restricted due to the ongoing Asahi litigation in the California
Despite continuing difficult economic conditions in southern Europe, trade and
other receivables decreased from CHF 536.5 million at the end of December 2011
to CHF 412.9 million at the end of the year. Days sales outstanding (DSO)
decreased from 103 days to 78 days.
During the first quarter of 2012, Actelion Spain enrolled in the Montorro
plan, which is designed to inject cash into the Spanish economy through
settlement of local authorities' commercial debt. Through this arrangement,
late in the second quarter, we collected over CHF 100 million from government
customers in Spain resulting in a partial reversal of doubtful debt
provisions. For the full year 2012, the total reduction in doubtful debt
provisions was CHF 22.6 million, compared to an increase in the provision of
CHF 43.2 million in 2011.
Investment in property, plant and equipment decreased to CHF 33.7 million in
2012, compared with CHF 89.4 million in 2011. The majority of this investment
relates to the construction of a research and development building. Total
property, plant and equipment at year-end was CHF 402.6 million, compared to
CHF 424.7 million at the end of 2011.
Total shareholders' funds amounted to CHF 1,518.6 million at the end of 2012
compared to CHF 1,510.5 million at the end of 2011.
Retaining an appropriate balance between attractive shareholder returns,
investment in the business and a strong capital structure will remain a
priority in the future. Actelion's Board proposes to increase the dividend
payment to CHF 1.00 from CHF 0.80 per share and will ask for shareholder
approval to do so at the upcoming Annual General Meeting on 18 April 2013.
During 2012, the company bought back 6.4 million shares at a total cost of CHF
264.2 million on the second trading line as part of the CHF 800 million share
repurchase program announced in October 2010. This brings the number of
treasury shares held to 13.8 million, or 11% of the total issued share
capital. The Board is committed to completing the current repurchase program
by the fourth quarter of 2013.
INTERNAL CONTROL OVER FINANCIAL REPORTING
Actelion is committed to maintaining strict oversight of its financial
reporting. In keeping with that commitment, for the seventh consecutive year,
the internal controls over financial reporting were certified as meeting the
requirements of SOX 404 (Sarbanes-Oxley Act 2002, section 404) at 31 December
CLINICAL DEVELOPMENT UPDATE
Actelion currently has 10 compounds in clinical development studied in several
therapeutic areas. The company is currently pursuing Phase III programs with
two different compounds with an additional two compounds in preparation for
Phase III investigation.
Actelion's clinical development pipeline:
Phase Product/ Compound Indication Study Resultsexpected
IV Bosentan Combination bosentan & COMPASS-2 2013
sildenafil in PAH
IV Bosentan Pediatric pulmonary FUTURE 2014
III Macitentan Pulmonary arterial SERAPHIN Complete
III Selexipag Pulmonary arterial GRIPHON 2014
III Macitentan Digital ulcers related to - 2014
II Cadazolid Clostridium difficile - Complete
II Ponesimod Multiple sclerosis - Complete
II Ponesimod Plaque psoriasis - Complete
I Anti-malarial Malaria - -
I CRTH2 receptor Asthma - -
I Lucerastat Lipid storage disorders - -
I NCE Immunological disorders - -
I Macitentan Glioblastoma - -
I S1Pmodulator Immunological disorders - -
For more information visit the corporate website:
At the end of 2012, Actelion employed 2,433 professionals worldwide, a
decrease of 5% (or 137 positions) compared to the end of 2011.
ASAHI KASEI PHARMA CORPORATION AGAINST ACTELION LTD
In 2008, a lawsuit was filed by Asahi Kasei Pharma Corporation against
Actelion Ltd, certain subsidiaries and three individual officers in a
Californian Superior Court. The action arises from a dispute involving the
license and development agreement between Asahi and CoTherix for the drug
compound fasudil that has been terminated upon the acquisition of CoTherix in
During 2011, the case was heard in trial court and resulted in a jury award of
compensatory and punitive damages. Following post-trial motions the trial
court entered a final judgment of USD 407.3 million and additional prejudgment
interest and costs of USD 8.3 million, in November 2011. The company and its
external advisors believe that the jury verdict and trial court judgment are
neither supported by the facts nor correct as a matter of law. The company
strongly believes that there are significant grounds for a successful appeal,
notice of which was filed with the California Courts of Appeal in December
2011. The appeal is proceeding as expected.
UNITED STATES ATTORNEY'S OFFICE FOR THE NORTHERN DISTRICT OF CALIFORNIA
In 2010, the company reported that its wholly owned US subsidiary Actelion
Pharmaceuticals US, Inc. had 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 US. The corresponding investigation is ongoing.
DEVELOPMENT OF COMPETING GENERIC PRODUCTS
During 2011 and 2012, three generic companies, Apotex Inc., Roxane
Laboratories, Inc. and Actavis Elizabeth, LLC demanded that Actelion provided
them samples of Tracleer and Zavesca for the purpose of developing competing
generic products. On September 14, 2012, Actelion filed a lawsuit against the
generic companies in the United States District Court for the District of New
Jersey seeking a declaratory judgment that Actelion has no legal duty or
obligation to sell any quantity of the drugs to generic competitors. In
response, the generic companies are alleging that Actelion violated federal
and state antitrust laws. Actelion has filed a motion requesting the Court
find in the company's favor based on the pleadings.
The Group is involved in commercial disputes in certain jurisdictions. The
possible losses which might arise as a result of the corresponding arbitration
proceedings range from CHF 0 million to CHF 18 million. At this time the
company cannot reasonably estimate the final outcome. The company expects a
resolution of these proceedings during 2013.
ABOUT 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
Founded in late 1997 Actelion 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
For further information please contact:
Senior 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
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