ALLSCHWIL and BASEL, Switzerland, Jan. 23, 2003 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN) (Other OTC:ALIOF) today reported operating revenues for the year 2002 of CHF 140.3 million (2001: 64.1 million). Sales were CHF 129.6 million (2001: 8.3 million). Of this later amount, CHF 121.8 million represented the rapidly growing sales of Tracleer(R) (2001: 3.4 million). In the fourth quarter of 2002, Tracleer(R) sales grew to CHF 47.5 million (Q3 02: 35.7 million).
When reporting its financial result for the year 2002 on February 18, 2003, the company expects to report a net loss at the lower end of the previously forecasted range of between CHF 45 and 50 million (net loss in 2001: 54.6 million).
Jean-Paul Clozel, M.D. and Chief Executive Officer commented: "I am very pleased with the strong starting performance of our first product, Tracleer(R), making this one of the most successful market introductions in the history of the biopharmaceutical industry. Despite a weakening U.S. Dollar, revenues have exceeded our expectations from a year ago. We are also encouraged by the uniform and immediate acceptance of Tracleer(R) and its novel mode of action, endothelin receptor antagonism, as the cornerstone in the treatment of pulmonary arterial hypertension (PAH)."
Andrew J. Oakley, Chief Financial Officer, commented:" For the year 2003, Actelion foresees strong growth from product sales, both in established markets and in markets still forthcoming. We expect sales to reach between CHF 270 and CHF 310 million, including revenues from Zavesca(TM), a novel treatment for Gaucher's type 1 disease to be launched throughout Europe starting in the first quarter of 2003. Especially in view of the strong uncertainty regarding currency fluctuations, Actelion will continue to closely manage its expenses so as to achieve -- unforeseen events excluded -- its forecasted 2003 single-digit net loss."
Tracleer(R) in the marketplace
Actelion is now marketing Tracleer(R), a dual endothelin receptor antagonist and the first orally available drug to treat pulmonary arterial hypertension, in key markets worldwide. In the United States, the market introduction occurred in mid-December '01. In Canada, the drug became available in mid-January 2002. In Europe, the launch started with Switzerland (April '02), followed by Germany and U.K. (June '02), France and Ireland (September '02), Austria and Italy (October '02) and in Greece and Sweden (November '02). At the end of December 2002, the company estimates that there were approximately 5,000 patients enrolled in the various paying distribution systems worldwide.
Further market introductions during 2003
At the beginning of January 2003, the product also became available in Spain. In the coming months, also patients in Finland, Holland, Denmark, Norway, Iceland as well as Belgium and Finland are expected to gain access to Tracleer(R).
Outside of Europe, Actelion is also planning for the commercial launch of Tracleer in Australia, where reimbursement discussions are ongoing following the recent approval of the product. In Japan, the second of two bridging studies was fully enrolled in late November, with a New Drug Application to be filed in spring of 2003. The company is currently also taking the necessary steps to launch the product in other parts of the world, for example in Brazil and in some South East Asian countries.
NOTE TO THE EDITOR:
The company will report its finance result on February 18, 2003.
The Analyst & Media day will take place on March 4, 2003.
Actelion Ltd.
Actelion Ltd. is a biopharmaceutical company, with its corporate headquarter 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 as well as Canada 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 focuses on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SWX Swiss Exchange (ticker symbol: ATLN).
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on
Thursday, January 23, 2003, 15:30 CET/09:30 AM EST:
Dial: +41 (0) 91 610 41 11 (Europe)
+1 412 858-4600 (U.S.)
Webcast -- Live and replay on demand Actelion webcasts its Investor Conference Call. On the Web, you may either follow the call live or have the call replayed later on demand. To access the webcast, simply visit the link on our homepage http://www.actelion.com for further information.