ALLSCHWIL, Switzerland, April 29, 2003 (PRIMEZONE) -- Actelion Ltd (SWX: ATLN) today announced its financial results for the first quarter 2003.
- Q1 2003 with operating profit of CHF 3.7 million and net profit of CHF 4.8 million
- Tracleer(R) momentum unchanged
- Major clinical programs underway
With operating revenues of CHF 63.7 million (Q1 2002: CHF 22.7m) and operating expenses of CHF 51.3 million (Q1 2002: 34.5m), the company reported an operating profit of CHF 3.7 million (Q1 2002 loss: -14.7m).
The net profit for Q1 2003 was CHF 4.8 million (Q1 2002 loss: CHF -10.9m). Accordingly the earnings per share (EPS) for Q1 2003 improved to CHF 0.22, compared to Q1 2002 with a loss per share of CHF (0.51).
Andrew J. Oakley, Chief Financial Officer commented: "I am very pleased that Actelion has achieved profitability after only five years of operations. This represents a major and almost unique achievement for a company in the area of biopharmaceuticals. On the back of strong Tracleer(R) sales, the company has now entered a phase of, unforeseen events excluded, sustained quarterly and annual profitability."
Jean-Paul Clozel, MD and Chief Executive Officer commented: "As the first approved oral therapy, Tracleer(R) has rapidly become the cornerstone of therapy for pulmonary arterial hypertension (PAH). I expect that patients and physicians alike will become even more interested in the long-term benefits of treating PAH with Tracleer(R) following the presentation of positive survival data at the upcoming American Thoracic Society." (1)
Significant increases in revenues
mio CHF Q1 2003 Q1 2002 Variance Total operating revenue 63.7 22.7 +40.9 +180.6% Cost of Sales 8.7 2.8 +5.9 +210.7% Operating Expenses 51.3 34.5 +16.8 +48.7% Operating Income 3.7 -14.7 +18.4 Net Income 4.8 -10.9 +15.7 EPS 0.22 -0.51 Cash & cash equivalent and Marketable securities 117.1 123.2 -6.1 -4.9% Number of employees 579 437 +142 +32.5%
The full financial statements can be found on http://www.actelion.com.
In the first quarter of 2003, Actelion had operating revenues of CHF 63.7 million (Q1 2002: CHF 22.7 m). Compared to the previous quarter (Q4 2002: CHF 49.9 m), this represented an increase of 27.7%.
In Q1 2003, Tracleer(R) sales were CHF 60.7 million (Q1 2002: 13.4 m). Compared to the previous quarter (Q4 2002: CHF 47.5 m), this represented an increase of 27.8%.
In Q1 2003, Tracleer(R) was launched in The Netherlands, Spain, Portugal and Finland and is now commercially available in the United States, Canada, Switzerland and in all EU markets with the exception of Denmark, Belgium and Luxembourg. Reimbursement discussions are ongoing in Australia. In Japan, Actelion filed for marketing authorization in early April 2003. Also in April 2003, regulatory review for Tracleer(R) started in Brazil.
In Q1 2003, Actelion also commenced the introduction of Zavesca(R), the first oral treatment option for type 1 Gaucher's disease, in the European Union (United Kingdom). During March 2003, the first patients started the screening process necessary to commence treatment. In early May, Zavesca(R) will be introduced in Germany.
In Q1 2003, Actelion's majority-owned subsidiary, Hesperion, contributed CHF 2.5 million (Q1 2002: CHF 1.5 m) with sales of clinical development services. Compared to the previous quarter (Q4 2002: CHF 2.4 m), this represented an increase of 4.2%.
Operating Expenses grow in line with corporate expansion
In Q1 2003 operating expenses were CHF 51.3 million (Q1 2002: CHF 34.5 m). Compared to the previous quarter (Q4 2002: CHF 45.1 m), this represents an increase of 13.8% and is in line with the expansion of the business.
In Q1 2003 marketing and selling expenses were CHF 23.9 million (Q1 2002: CHF 15.2 million). Compared to the previous quarter (Q4 2002: CHF 21.8 m), this represents an increase of 9.6%. Marketing and selling expenses are expected to grow in the quarters ahead, due to increased pre-marketing efforts for Tracleer(R) in Japan. In addition, Actelion will be present at many major scientific congresses taking place in the coming nine months.
In Q1 2003 research and development expenses were CHF 19.4 million (Q1 2002: CHF 14.5 m). Compared to the previous quarter (Q4 2002: CHF 15.6 m), this represents an increase of 24.4%. This reflects the numerous clinical programs with Tracleer(R) and tezosentan (Veletri(R)) which were initiated in Q1 2003.
In Q1 2003 management and general expenses amounted to CHF 7.9 million (Q1 2002: CHF 4.8 m). Compared to the previous quarter (Q4 2002: CHF 7.7 m), this represents an increase of 2.6%.
In Q1 2003, strong sales revenue and tight cost control led to an operating profit of CHF 3.7 million (Q1 2002 loss: CHF -14.7 m). Operating loss in Q4 2002 was CHF -2.7 m.
In Q1 2003, Actelion generated a net profit of CHF 4.8 million (Q1 2002 loss: CHF -10.9 m). Net loss in Q4 2002 was CHF -0.6 m.
Ongoing discovery and development efforts at Actelion
In late 2002 and early 2003, clinical programs involving Tracleer(R) have been initiated in idiopathic pulmonary fibrosis and pulmonary fibrosis related to scleroderma (BUILD Program, Phase II/III) and Tracleer(R) in metastatic melanoma (proof-of-concept study). In late March, the metastatic melanoma study started to enroll patients.
Also in Q1 2003, the European regulatory body EMEA has granted Tracleer(R) orphan drug status in Systemic Sclerosis (Scleroderma).
In April 2003, enrollment also started in the VERITAS program, evaluating mortality/morbidity benefits with Actelion's intravenous dual endothelin receptor antagonist tezosentan (Veletri(R)), in patients suffering from acute heart failure.
In Q1 2003, Actelion also initiated Phase II studies with tezosentan to evaluate its use in hepatorenal syndrome (HRS). One trial site in Toronto is currently not enrolling patients, as the hospital in question has been closed following an outbreak of SARS. Therefore, the decision on initiating a Phase III might not take place until Q4 2003.
In addition to Tracleer(R) and tezosentan, several clinical trials are also ongoing involving Zavesca(R), evaluating the drug in lipid storage diseases other than type 1 Gaucher disease.
At the beginning of Q1 2003, Actelion started a clinical program with its urotensin II receptor antagonist - the first ever brought into the clinic. The company expects this phase I trial to conclude later this year.
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).
For further information please contact:
Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil
Media Contact Peter Engel +41 61 487 36 28
Investor Contact Roland Haefeli +41 61 487 34 58 +1 650 624-6936
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Tuesday, 29 April 2003, 15.30 CET / 09.30 AM EST / 14.30 GMT Dial: +41 (0) 91 610 56 00 (Europe) +1 412 858-4600 (U.S.) +44 207 107 06 11 (U.K.)
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.
(1) At the upcoming American Thoracic Society (ATS), Vallerie McLaughlin, MD, St Luke Section of Cardiology, Rush Presbyterian Medical Center, Chicago, will present an independent analysis of long-term follow-up data involving 169 patients previously enrolled into the Tracleer(R) pivotal registration studies. The abstract covering Dr. McLaughlin's presentation is available on the ATS website. (www.thoracic.org) and directly at http://www.abstracts2view.com/ats)