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Actelion Pharmaceuticals Ltd / Actelion delivers strong performance in 2012 - Getting ready for
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ALLSCHWIL/BASEL, SWITZERLAND - 14 February 2013- Actelion Ltd (SIX: ATLN) today announced
financial results for the full year 2012.
*(R)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
*(R) Solid Tracleersales in a challenging environment, up 1% in volume (down 4% in local
*(R) Regulatory approvals for improved formulation of Veletriin US, Switzerland and Canada
*Clostridium difficilePonesimod in psoriasis and cadazolid in associated diarrhea to move into
Phase III during 2013 following successful mid-stage study results
*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
*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(R)) 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 its development."
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 http://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(R) 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
No 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.
*Q1 Financial Results 2013 reporting on 16 April 2013
*Annual General Meeting of Shareholders on 18 April 2013
*HY 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(R)), 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 implementation.
SUSTAINING GLOBAL LEADERSHIP IN PAH THERAPY
Actelion is sustaining its leadership in the PAH market with its broad range of products. In 2012,
Tracleer(R) 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(R), which is
formulated for optimized inhalation time, continued to be an important source of revenue for our
Veletri(R) 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
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 with PAH.
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
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 S1P1 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 profitability.
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
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
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
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
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(R) 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 million.
Other financial expenses for the year amounted to CHF 10.6 million, compared to CHF 22.9 million
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 year.
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 repurchases.
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
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
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 Results expected
IV Bosentan Combination bosentan & sildenafil in PAH COMPASS-2 2013
IV Bosentan Pediatric pulmonary arterial hypertension FUTURE 2014
III Macitentan Pulmonary arterial hypertension SERAPHIN Complete
III Selexipag Pulmonary arterial hypertension GRIPHON 2014
III Macitentan Digital ulcers related to systemic sclerosis - 2014
II Cadazolid Clostridium difficile associated diarrhea - Complete
II Ponesimod Multiple sclerosis - Complete
II Ponesimod Plaque psoriasis - Complete
I Anti-malarial Malaria - -
I CRTH2 receptor antagonist Asthma - -
I Lucerastat Lipid storage disorders - -
I NCE Immunological disorders - -
I Macitentan Glioblastoma - -
I S1P1 modulator 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 2007.
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(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.
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 SMI(R)).
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
Financial Statement http://hugin.info/131801/R/1677848/547380.pdf
Financial Fact Sheet http://hugin.info/131801/R/1677848/547378.pdf
Press Release PDF http://hugin.info/131801/R/1677848/547373.pdf
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland