Actelion reports financial figures for Q2 2001

Spending focus on US marketing and ongoing clinical development

Allschwil, Switzerland - August 7, 2001 - Actelion Ltd (SWX New Market: ATLN) reported today 2nd quarter operating revenues of CHF 14.5 million (Q1: 14.3 million, half-year: 28.8 million), the result of the ongoing recognition of milestone payments received earlier this year. The company recorded operating expenses of CHF 30.7 million (half-year: 59.6 million), slightly above the previous quarter (Q1: 28.9 million).
 
Konrad P. Wirz, Chief Financial Officer of Actelion, said: "In the past few months, Actelion has continued its focus on marketing spending in the United States. With a planned sales-force of 35 and a strong US headquarter presence in South San Francisco, we want to ensure a successful market introduction of our first product, TracleerTM in pulmonary arterial hypertension (PAH)."
 
Tracleer(TM) in PAH is currently under review by the U.S. Food and Drug Administration (FDA) and other regulatory bodies worldwide. On August 10th, a FDA advisory panel will review Actelion's application for marketing authorization. Briefing books prepared by both the FDA and Actelion for this public meeting will be made available by the FDA on their website Thursday, August 9th at 8:30 a.m. Eastern Standard Time (14:30 Central European Time).
 
Substantial cash position to fully fund all activities
 
In Q2 2001, the company recorded an operating loss of CHF 16.2 million (Q1: 14.6 million, year-to-date: 30.8 million). With financial income and tax credits at CHF 6.6 million (Q1: 6.1 million), the resulting net loss was CHF 9.7 million (Q1: 9.1 million, half-year: 18.8 million). On 30 June 2001, the company reported cash and equivalents of CHF 218.3 million (31 March 2001: 250.3 million).
 
Konrad P. Wirz commented further: "Our substantial net cash position provides us with the necessary means to fully fund our pre-launch and marketing activities as well as all our ongoing development programs and the seven preclinical drug discovery projects."  Actelion, in conjunction with Genentech, is currently also developing Tracleer(TM) in chronic heart failure (CHF) in two ongoing Phase III studies named ENABLE 1 and 2 (Endothelin Antagonist Bosentan for Lowering Cardiac Events in Heart Failure) started in June 1999. These event-driven studies were fully enrolled in August 2000 with 1613 patients. So far 555 adjudicated events were recorded out of the 600 necessary to assess mortality and morbidity benefits of Tracleer(TM) in CHF-patients in Class IIIb/IV. Top-line results of the ENABLE program are expected in Q1 2002.
 
With the intention to design new clinical trials, Actelion is also further analyzing in detail, data from the RITZ (Randomized Intravenous TeZosentan) program evaluating Veletri in acute heart failure. Results will be presented at the upcoming European Society of Cardiology (ESC) Congress by John D. Teerlink, MD, Assistant Professor of California School of Medicine, and Director of the Heart Failure Clinic, San Francisco VA Medical Center, San Francisco, California, on September 4th 2001. Actelion will announce the new clinical trial plan the same day.
 
Actelion key figures and accounting remarks
 
Actelion's key figures for the second quarter 2001 compared to second quarter 2000 and first quarter 2001 are as follows (in million of CHF):
 
 
As communicated at the beginning of this year, Actelion is applying a new accounting standard adopted industry-wide for the recognition of revenues (SAB 101) from research and development cooperation.  Reported operational revenues in Q2 2001 of CHF 14.5 million only reflect a pro-rated recognition of a milestone payment (TracleerTM agreement with Genentech) received in full in early January 2001. Total revenues for the full year 2001 are projected at approximately CHF 60 million, almost double from that in the year 2000 (CHF 31.6 million).
 
The reviewed and fully consolidated financial statements for the half-year ending June 30, 2001 are available on www.actelion.com.
 
Actelion Ltd, a biopharmaceutical company headquartered in Allschwil/Basel, Switzerland, is a leading player in creative science related to the endothelium - the single layer of cells separating every blood vessel from the blood stream.  Actelion concentrates on developing and bringing innovative drugs to patients. TracleerTM and Veletri TM are in development for several cardiovascular disorders, including chronic and acute heart failure as well as pulmonary arterial hypertension.  In addition, Actelion is conducting drug discovery programs in cardiovascular diseases, malaria, Alzheimer's disease and cancer.  Actelion is quoted on the SWX Swiss Exchange (SWX New Market: ATLN).

Press release (PDF)