ALLSCHWIL/BASEL, Switzerland, Nov. 5, 2002 (PRIMEZONE) -- Actelion Ltd. (Other OTC:ALIOF) (SWX:ATLN) today reported results for the 3rd quarter 2002. Total operating revenues for Q3 2002 were CHF 39.4 million (Q2: 28.4 million; nine-month: 90.4 million). Compared with the preceding quarter, the operating loss decreased by 28.6 percent to CHF 10.7 million (Q2: 15.0 million, nine-month: 40.4 million). The net loss decreased by 42.4 percent to CHF 10.7 million (Q2: 18.6 million, nine-month: 40.2 million).
Sales Revenues Increased by 41 percent
Sales revenue increased to CHF 38.0 million (Q2: 26.9 million; nine-month: 79.8 million). Of this amount, CHF 35.7 million represented the rapidly growing sales of Tracleer(TM) (Q2: 25.2 million, nine-month: 74.3 million). Compared with the preceding quarter, Tracleer(TM) sales increased by 41.6 percent.
Andre J. Mueller, Chief Financial Officer, commented: "Nine months after first being introduced to the market, Tracleer(TM) sales continue to grow strongly in the United States and also in Europe. Unforeseen events excluded, Actelion now expects Tracleer(TM) sales to reach between CHF 115 and 120 million by year-end, up 15 percent from our previous forecast."
Actelion is now marketing Tracleer(TM), a dual endothelin receptor antagonist and the first orally available drug to treat pulmonary arterial hypertension, in the United States, Canada, the European Union (Austria, France, Germany, Italy, Sweden, United Kingdom) and Switzerland. At the end of September 2002, there were more than 3'800 revenue-generating patients on the drug worldwide (end of June 2002: 2'600). By the end of the year, the company expects that more than 5'000 revenue-generating PAH patients will benefit from therapy with Tracleer(TM).
Operating Result Continues to Improve
Total operating expenses in Q3 were CHF 44.9 million (Q2: 39.5 million, nine-month: 119.0 million). Compared with the preceding quarter, operating expenses increased by 13.6 percent.
Actelion continued to appropriately support Tracleer(TM) marketing activities and to build up the necessary infrastructure in key markets worldwide. Accordingly, Marketing and Sales expenses were at CHF 22.3 million (Q2: 19.6 million, nine-month: 57.1 million), Management and General at CHF 7.4 million (Q2: 5.5 million; nine-month: 17.7 million).
With R&D expenses almost unchanged at CHF 15.2 million (Q2: 14.4 million; nine-month: 44.2 million), the company recorded a substantially improved operating performance, with a Q3 operating loss of CHF 10.7 million. (Q2: 15.0 million, nine-month: 40.4 million).
Neutral Finance Result after Limiting Exposure to Currency and Securities Market
As a result of the company's decision during Q2 to substantially reduce its holdings in securities holdings and its deposits in USD, the finance result improved considerably in comparison to the previous quarter, to CHF 0.1 (Q2: CHF 4.9, nine-month 4.6 million).
With income tax benefits and minority interest at CHF 0.1 million (Q2: 1.3 million, nine-month: 4.8 million), the company's net loss was also substantially reduced to CHF 10.7 million (Q2: 18.6 million, nine-month: 40.2 million). Compared with the preceding quarter, the net loss decreased by 42.5 percent. Loss per share amounted to CHF 0.50 for the quarter and CHF 1.89 for the nine-months.
On September 30, the company has cash and investments totaling CHF 93.9 million (30 June: 101.1 million).
Andre J. Mueller, Chief Financial Officer, commented: "With strong Tracleer(TM) sales momentum, Actelion is in a very good growth position. The resulting working capital requirements are covered by available bank facilities. Our continuously strengthening performance allows us to appropriately invest in marketing and R&D without compromising profitability, with the first profitable quarter still expected during 2003."
Q3 2001 Q3 2002 Q2 2002 Variance Q3 2002 / Q2
2002
Sales 2.2 38.0 26.9 41.2%
Cost of Sales 1.5 5.1 3.8 34.2%
Gross Profit 0.7 32.9 23.0 43.0%
Other Operating Income 17.3 1.4 1.5 6.6%
Operating Expenses 30.2 44.9 39.5 13.6%
Operating Income (12.1) (10.7) (15.0) 28.6%
(Loss)
Net Income (Loss) (17.3) (10.7) (18.6) 42.4%
Cash and Cash Equiv. 181.0 93.9 101.1
The consolidated financial statements for the first nine months ending September 30, 2002 are available on www.actelion.com.
On September 30, 2002, Actelion counted more than 520 employees worldwide (June 30, 2002: 478).
Further Tracleer(TM) Launches in the EU Progress in Australia
In the European Union, Actelion expects Tracleer(TM) to be available in almost all EU markets by the end of 2002.
In Australia, another milestone in making Tracleer(TM) available to patients has been reached. The drug has been recommended for the treatment of PAH in both adults and children, with final approval expected by the regulatory authority TGA later this year.
The recommendation for use in children follows submission of clinical trial data from BREATHE-3. This study demonstrated that Tracleer(TM), given in doses adapted to body weight, resulted in statistically significant improvements in hemodynamic parameters in children suffering from Primary Pulmonary Arterial Hypertension (PPH) and PAH associated with congenital heart disease.
In Japan, Actelion's bridging study necessary to file for marketing approval is close to full enrollment. The filing of a new drug application (NDA) is now foreseen for spring 2003.
Evaluation of Endothelin Receptor Antagonism in Other Indications
Actelion is evaluating the potential of endothelin receptor antagonism in other diseases where endothelin plays an important role as a pathogenic mediator.
During the second quarter, the company reported important data from RAPIDS-1, evaluating the safety and efficacy of Tracleer(TM) in sclerodermarelated digital ulceration. In this study, the use of Tracleer(TM) significantly reduced the occurrence of new digital ulcerations. The company expects to initiate a second study during 2003 to further establish the benefits of Tracleer(TM) in this endothelinrelated complication of scleroderma.
Several other Actelion clinical teams are currently working with experts worldwide to finalize the details of clinical programs evaluating bosentan in both pulmonary fibrosis due to scleroderma as well as idiopathic pulmonary fibrosis. The company expects that these trials will be initiated during the first quarter 2003. In the same quarter, Actelion also expects to initiate first trials with Tracleer(TM) in malignant melanoma.
By year-end, Actelion will initiate its Phase III program with Veletri(TM), an intravenous dual endothelin receptor antagonist under evaluation for the treatment of acute heart failure (AHF). This follows the successful conclusion of a dose-optimization study during Q3 2002. The study shows that lower than previously evaluated doses of Veletri(TM) resulted in statistically significant improvements in hemodynamic parameters. At these doses, Veletri(TM) was well tolerated and no clinically relevant differences in side effects were observed between Veletri(TM) and placebo.
Actelion and OGS Working Closely to Register and Launch Zavesca(TM) in Europe
Actelion is currently proceeding with registration and launch efforts for Zavesca(TM), a small molecule developed by Oxford Glycoscience plc (OGS) for the treatment of type 1 Gaucher disease. In July 2002, Actelion and OGS had announced the signing of a binding letter of intent for a European marketing and distribution partnership. Approval is expected by year-end, with first launches in the EU possible during Q1 2003.
Update on Preclinical Projects
Actelion continues to focus its research efforts on four of its most advanced preclinical projects. By early 2003, the company expects to initiate human trials for an orally available urotensin II receptor antagonist. The company believes that this is the first time that a compound of this class will be entered into clinical development. Other ongoing projects involve orexin receptor antagonists, renin inhibitors and beta-secretase inhibitors.
Actelion and Johnson&Johnson are currently engaged in discussions about new terms regarding their research collaboration that expired in July 2002. In the meantime and upon demand, Actelion is providing preclinical services to Johnson&Johnson.
Actelion Ltd.
Actelion Ltd. is a biopharmaceutical company, with its corporate headquarter in Allschwil/Basel, Switzerland. Actelion's first drug Tracleer(TM), an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer(TM) 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 Swiss Stock Exchange (SWX ATLN).
Contact at Actelion Ltd., Gewerbestrasse 16, CH4123 Allschwil: Media/Investor Contacts Roland Haefeli 41 61 487 34 58 1 650 6246936 http:// www.actelion.com
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A onTuesday, November 5, 2002, 15:30 CET/09:30 AM EST.
Dial:41 (0) 91 610 41 11 (Europe)1 412 8584600 (U.S.)
Webcast Live and replay on demand Actelion now 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.
To view the financial tables for this release, please click the link: http://reports.huginonline.com/880143/109889.pdf