ALLSCHWIL/BASEL, Switzerland, April 27, 2004 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) today announced its financial results for the first quarter of 2004. With net revenues of CHF 101.1 million (Q1 2003: CHF 62.7 m) and operating expenses of CHF 81.3 million (Q1 2003: 56.8 m), the company reported an operating profit of CHF 19.8 million (Q1 2003: CHF 5.9 m).
First quarter ever with net revenues exceeding CHF 100 million:
-- Increase of 61 percent to CHF 101.1 million compared to Q1 2003
-- Strong Tracleer(r) sales of CHF 97.1 million
-- Operating expenses of CHF 81.3 million reflecting ongoing
investment in both marketed products and expanding R&D
-- Operating profit of CHF 19.8 million, up 234% compared to Q1 2003
-- Net profit of CHF 27.7 million including gain from the divestment
of Hesperion
The net profit for the quarter was CHF 27.7 million (Q1 2003: CHF 4.1 m), which included a gain of CHF 9.6 million from the divestment of Hesperion. Basic earnings per share (EPS) for the first quarter of 2004 improved to CHF 1.27, compared to CHF 0.19 in Q1 2003. The gross cash position as at 31 March 2004 was CHF 283.4 million (31 December 2003: CHF 258.8 million).
Jean-Paul Clozel, MD, Chief Executive Officer commented: "Actelion's operational performance is very satisfactory. I am also pleased that this quarter again highlights that we are pursuing the right strategy. We are expanding the use of our products in the marketplace. At the same time, we expand and advance our promising portfolio of pre-clinical and clinical projects. I look forward to share with you the results of discovery and development efforts that will become available in the coming months."
Andrew J. Oakley, Chief Financial Officer commented: "Actelion is well on track to meet all of its goals for 2004, not only those related to revenues. The management team is fully committed to continue its policy to focus and prioritize the company's efforts in areas of high return, in terms of both products in the market place and clinical and pre-clinical projects."
Financial result overview -- Table Q1 2004 vs. Q1 2003
In CHF thousands Result Q1 Result Q1 Variance in%
2004 2003
Net Revenues 101'053 62'740 +38'313 +61
Operating Expenses 81'299 56'821 +24'478 +43
Operating Profit 19'754 5'919 +13'835 +234
Net Profit 27'715 4'126 +23'589 +572
Basic EPS in CHF 1.27 0.19 +1.08 +568
Diluted EPS in CHF 1.20 0.19 +1.01 +532
Cash & cash equivalents 283'409 101'714 181'695 +179
The full financial statements for the first quarter 2004 can be found on http://www.actelion.com.
In the first quarter of 2004, net revenues increased to CHF 101.1 million (Q1 2003: 62.7m), including Tracleer(r) sales of CHF 97.1 million (Q1 2003: 60.7 m), Zavesca(r) sales of CHF 0.8 million (Q1 2003: not launched) and contract revenues of CHF 3.2 million (Q1 2003: 2.0 m).
Increased operating profitability
Operating expenses increased to CHF 81.3 million (Q1 2003: 56.8 m), with research and development costs at CHF 29.1 million (Q1 2003: 18.9 m), marketing and advertising expenses at CHF 19.9 million (Q1 2003: 17.3 m), and selling, general and administration expenses at CHF 21.8 million (Q1 2003: 13.8 m). Cost of goods sold was CHF 9.9 million (Q1 2003: 6.5 m).
The operating profit in the first quarter of 2004 amounted to CHF 19.8 million (Q1 2003: CHF 5.9 m).
Non-operating items and cash
The Net Profit of CHF 27.7 million (Q1 2003: 4.1 m), includes interest income of CHF 0.2 million, interest expense of CHF 0.2 million, a non cash interest charge on the Convertible Bond of CHF 1.8 m, foreign currency gains of CHF 1.4 m, an income tax expense of CHF 1.2 m, and a gain from the divestment of Hesperion of CHF 9.6 m.
On 31 March 2004, the company held cash and cash equivalents of CHF 283.4 million (31 December 2003: CHF 258.8 million). The company generated positive free cash flow in the first quarter of 2004 of CHF 20.7 million.
Tracleer(r) marketing ensuring long-term business growth
At the end of March 2004, Tracleer(r) was marketed in 18 countries worldwide, including almost all major pharmaceutical markets. In Australia, Tracleer(r) became commercially available on 1 March 2004. In Japan and Taiwan, the regulatory reviews are ongoing, however sales on a named patient basis are underway in Taiwan. In Brazil, reimbursement discussions are ongoing.
Simon Buckingham, President Actelion North America and Asia Pacific, commented: "Actelion is currently preparing and launching broad new educational programs to further expand the use of Tracleer(r) by increasing disease awareness and -- consequently -- diagnosis and treatment of pulmonary arterial hypertension. With these efforts, we believe that Tracleer(r) can fully reach both its medical and commercial potential."
Zavesca(r) now approved in Europe, the US and Canada
Zavesca(r) was first launched in the United Kingdom and in Germany in April 2003. The drug became commercially available in the United States in early January 2004. In March 2004 Zavesca(r) was also approved in Canada and commercial launch of the drug is expected later this year.
Research and Development programs on track
Actelion provided a full update on its discovery and development programs on the 4th of March 2004. All projects are proceeding as discussed.
In June 2004, the company expects a communication from the independent Drug Safety Monitoring Board (DSMB) regarding the continuation of the VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study) program. These pivotal studies are evaluating VeletriTM 's in dyspnea as well as mortality-morbidity benefits in up to 1800 patients suffering from acute heart failure (AHF). If the futility analysis indicates that the trials have a statistical chance of achieving either endpoint, the DSMB will advise that the program should continue.
Also in Q2 2004, Actelion expects to report results from its small exploratory Phase II studies, Tracleer(r) in metastatic melanoma and VeletriTM in hepatorenal syndrome.
For documentation purposes -- table Q1 2004 vs. Q4 2003
In CHF thousands Results Q1 Results Q4 Variance in %
2004 2003
Net Revenues 101'053 93'796 + 7'257 +8
Operating Expenses 81'299 127'623 - 46'324 -36
Operating Profit/Loss 19'754 -33'827 + 53'581 n/a
Net Profit/Loss 27'715 -37'120 + 54'835 n/a
Basic EPS in CHF 1.27 -1.71 + 2.98 n/a
Cash & cash equivalents 283'409 258'770 + 24'639 +9
Note: Operating expenses of the fourth quarter of 2003 included a one-time in-process R&D charge of CHF 47 million related to the acquisition of Axovan.
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 Tuesday, 27 April 2003, 15.30 CET / 09.30 a.m. EST / 14.30 GMT Dial: +41 (0) 91 610 56 00 (Europe) +1 866 291 41 66 (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 live, simply visit the link on our homepage http://www.actelion.com/ 5-10 minutes before the conference is due to start.
Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay through our homepage. After 11 May 2004 it will be stored under Investors/Past Events.
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