Total net revenues of CHF 501.7 million - Product sales of CHF 449.8 million, up 20 percent in local currencies - Non-GAAP EBIT of CHF 197.8 million - US launch of improved formulation of Epoprostenol for Injection

ALLSCHWIL/BASEL, SWITZERLAND - 22 April 2010 - Actelion Ltd (SIX: ATLN) today announced financial results for the first quarter 2010.  

As of 31 March 2010, Actelion had cash, cash equivalents and marketable securities of CHF 1.2 billion. In addition, Actelion holds 10.3 million treasury shares.

In the first quarter of 2010 Actelion continued its growth trajectory, driven yet again by strong demand for its medicines. These results support previously announced 2010 guidance of more than 10 percent net revenue growth (in local currencies) and non-GAAP EBIT growth close to 20 percent (in local currencies).

On 22 April 2010, Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, has become available for the treatment of primary pulmonary hypertension and pulmonary hypertension associated with scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. The introduction of this product demonstrates Actelion's ongoing commitment to the pulmonary arterial hypertension (PAH) community. It also expands Actelion's product portfolio to four marketed medicines.

Actelion's leading role in the treatment of PAH is further evidenced by two late-stage development candidates - macitentan, a highly potent, tissue-targeting endothelin receptor antagonist and selexipag (proposed INN), a first-in-class, orally active non-prostanoid, selective IP receptor agonist.

At the end of March 2010 Actelion had a total of 11 different molecules in clinical development. In addition to macitentan and selexipag, Actelion is also conducting Phase III programs of clazosentan in non-traumatic aneurismal subarachnoid hemorrhage (aSAH) and almorexant in sleep disorders.

Jean Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "I am very pleased with our performance this quarter, including the robust demand for our products and our strong financial performance. This ongoing strong demand for our medicines positions us well for the future, and allows us to make appropriate investments in a wide range of innovative development candidates. The introduction of new products, like the improved epoprostenol formulation, will also enable us to further leverage our global infrastructure."

Revenue performance

Product sales for the first quarter of 2010 were CHF 449.8 million (Q1 2009 CHF 389.4 million, an increase of 20 percent in local currencies) with 43 percent coming from the United States, 42 percent coming from Europe and 15 percent from the rest of the world. Product sales growth was mostly driven by patient demand.

Sales of Tracleer® (bosentan) were CHF 405.2 million for the first quarter of 2010, compared to CHF 352.2 million for the same period in 2009, representing a 19 percent increase in local currencies.

During the first quarter of 2010, Ventavis® (iloprost) had sales in the United States of CHF 27.7 million compared to CHF 27.0 million in the first quarter of 2009, representing an 11 percent increase in local currencies.

Sales of Zavesca® (miglustat) for the first quarter of 2010 were CHF 16.9 million, compared to CHF 10.3 million during the same period last year, representing a 69 percent increase in local currencies.  

Contract revenues for the first quarter 2010 were CHF 51.9 million compared to CHF 16.2 million in the first quarter of 2009. The increase was primarily driven by the accelerated recognition of Roche S1P1 milestones that will come to an end in Q2 2010.

Operating expenses

Total operating expenses for the first quarter of 2010 were CHF 338.4 million compared to CHF 284.0 million for the same period in 2009, an increase of 19 percent. The increase was driven by both, ongoing investments into R&D as well as ongoing investments to further expand the use of our marketed products.

Research and Development (R&D) expenses in the first quarter of 2010 were CHF 116.1 million compared to CHF 95.8 million in the first quarter of 2009. Non-GAAP R&D expenses for the first quarter of 2010, which excludes stock-based compensation expense and amortization and depreciation, were CHF 104.4 million compared to CHF 86.4 million in the first quarter of 2009.  

Selling, General and Administrative expenses (SG&A) for the first quarter of 2010 were CHF 163.8 million compared to CHF 138.8 million in the first quarter of 2009. Non-GAAP SG&A expenses for the first quarter of 2010, which excludes stock-based compensation expense and amortization and depreciation, were CHF 151.7 million compared to CHF 129.7 million in the first quarter of 2009

Andrew J. Oakley, Chief Financial Officer of Actelion commented: "This is yet another set of solid results demonstrating that Actelion is continuing to operate from a strong base. I am confident that we will meet our guidance for 2010. Our strong balance sheet also enables us to continue the evaluation of external growth opportunities."  

Corporate updates

• On March 1, 2010 Actelion announced initial results of BUILD-3, a clinical study evaluating the safety and efficacy of bosentan in patients suffering from idiopathic pulmonary fibrosis (IPF). Whilst there was a consistent trend in favor of bosentan, the primary endpoint, reduction in morbidity/mortality, was not met (p=0.21). Following completion of full data analysis, BUILD-3 findings will be presented at the upcoming American Thoracic Society (ATS) Annual Meeting and in peer-reviewed publications. 

• On March 9, 2010 Actelion announced that the company had received a complete response letter from the U.S. Food and Drug Administration (FDA) for its supplemental New Drug Application for Zavesca® for the treatment of progressive neurological manifestations in adult and pediatric patients with Niemann-Pick type C (NP-C) disease, a rare, neurodegenerative genetic disorder. The FDA has requested additional preclinical and clinical information and Actelion will work diligently with the FDA to explore the best ways to address the points raised by the agency. 

• On 22 April 2010, Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, has become available in the US. This formulation is indicated for the treatment of primary pulmonary hypertension and pulmonary hypertension associated with scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy. Simultaneously, Actelion has launched the PROSPECT registry, a multicenter, observational, US-based registry that will provide additional clinical experience on patients being treated with Epoprostenol for Injection.
   

• In the first quarter, Actelion initiated the EPITOME clinical program that will generate additional clinical experience data with Epoprostenol for Injection. In early 2010, Actelion also commenced the process to obtain regulatory approval in markets outside the U.S., beginning with a filing in France. 

Upcoming events

• Annual General Meeting of shareholders on 4 May 2010 in Basel (Congress Centre 14.00). 

• Efficacy, safety and tolerability results from the Phase IIa study of selexipag in PAH will be presented by Prof. G. Simonneau MD, PhD, Clamart, France at the American Thoracic Society (ATS) congress in New Orleans in the morning of Monday 17 May 2010, Central Time (US). 

• Actelion to host a PAH product and franchise overview during a company-sponsored investor reception in New Orleans on Monday, 17 May 2010, 6pm Central Time (US). 

• Actelion to report H1 financial results on 20 July 2010, at which point in time the company will provide a comprehensive clinical pipeline update and issue its 2010  half year report. 

• Actelion to report, in October 2010, the results from CONSCIOUS-2, a Phase III study evaluating the clinical benefits of clazosentan on vasospasm-related morbidity and all-cause mortality post aneurysmal subarachnoid hemorrhage. This study is expected to complete enrollment, with close to 1,150 patients, at the end of April 2010. 

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Notes to the editor:

Actelion Ltd.

Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, Switzerland.  Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension.  Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland. Actelion, founded in late 1997, is a leading player in innovative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream.  Actelion's over 2,300 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).

Conference Call Information

An investor conference call & webcast will be held at 14.00 hrs, CEST to discuss the results. Please note this is a new time as a response to your feedback.

Date/Time:

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Dial-in participants should start calling the number below 10-15 minutes before the conference is due to start.

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 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/20100422/trunc

Participant's mode:

Listen-Only with possibility to ask individual questions by clicking on the Q&A button.
Participants will be asked to provide their Name and Company.

Webcast Replay:

The archived Investor Webcast will be available for replay through http://www.actelion.com/

approximately 60 minutes after the call has ended.  

For further information please contact:

Roland Haefeli

Vice President, Head of Investor Relations & Public Affairs

Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil

+41 61 565 62 62

+1 650 624 69 36

www.actelion.com

Full Financial Statement:

The full financial statement for the first quarter of 2010 can be found as a PDF attached to the media release.