ALLSCHWIL, Switzerland, Oct. 26, 2004 (PRIMEZONE) -- Actelion Ltd. (SWX:ATLN) today announced its financial result for the first nine months of 2004. With total net revenues for the first nine months of 2004 of CHF 341.5 million (9 m 2003: CHF 209.1 m) and operating expenses of CHF 277.6 million (9 m 2003: 181.1 m), the company reported an operating profit of CHF 63.9 million (9 m 2003: CHF 28.0 m). The net profit for the first nine months of 2004 was CHF 64.2 million (9 m 2003: CHF 23.1 m).
Total net revenues up 63% reaching CHF 341.5 million for the first
nine months of 2004
-- Strong organic Tracleer(r) growth in Pulmonary Arterial
Hypertension results in sales of CHF 325.4 m
-- Operating expenses of CHF 277.6 million reflecting continuous
business expansion
-- All clinical programs on or ahead of schedule
-- Operating profit of CHF 63.9 million
-- Upgraded guidance for Full Year 2004
Basic earnings per share (EPS) for the first nine months of 2004 improved to CHF 2.92, compared to CHF 1.07 in the first nine months of 2003. The gross cash position as of 30 September 2004 was CHF 273.7 million (30 June 2004: CHF 244.8 million).
Andrew J. Oakley, Chief Financial Officer commented: "I am very pleased with the financial result for the first nine months of 2004. Tracleer(r) sales growth has been higher than expected, most likely due to our ongoing educational activities. Our costs continued to increase in-line with both our expectations and the expansion of our business activities."
Andrew J. Oakley concluded: "Unforeseen events excluded, I now expect our total net revenues for 2004 to reach between CHF 455 to 470 million. Our overall cost structure should continue to develop in-line with our plans to further invest in both marketing and sales as well as research and development. Accordingly, I believe that Actelion should report a substantially higher than expected operating profit for the year."
Jean-Paul Clozel, MD and Chief Executive Officer, commented: "I am delighted with our overall performance for the first nine months of 2004. In addition to an outstanding financial result, our clinical programs have advanced further. Three clinical studies with Tracleer(r) -- in Digital Ulcerations and two forms of Pulmonary Fibrosis -- have achieved full enrollment. Also, the clinical study evaluating tezosentan in acute heart failure has now enrolled more than 75 percent of the foreseen 1'760 patients. This will allow the independent Drug Safety Monitoring Board to perform the second futility analysis sometime in early November."
Jean-Paul Clozel concluded: "With many advanced clinical trials reporting results in the next 15 months, a thriving early-stage clinical pipeline and a highly productive research effort, Actelion is well prepared for the future. For the months ahead, we are adding to the current sales momentum through the ongoing sales force optimization. Actelion is in the process of hiring around 50 territory managers in addition to the 150 already in the field. We believe this is the most efficient way to further capitalize on the strong trend of early diagnosis and treatment of PAH with Tracleer(r), a proven dual endothelin receptor antagonist directly addressing the endothelin dysfunction in this rapidly progressing disease."
Financial result overview -- Table 9 months 2004 vs. 9 months 2003
In CHF thousands Result 9 Result 9
months 2004 months 2003 Variance in %
Net Revenues 341'517 209'148 132'369 +63
Operating Expenses 277'628 181'122 96'506 +53
Operating Profit 63'889 28'026 35'863 +128
Net Profit 64'150 23'067 41'083 +178
Basic EPS in CHF 2.92 1.07 1.85 +173
Diluted EPS in CHF 2.78 1.03 1.75 +170
Cash & cash equivalents 273'727 136'639 137'088 +100
The full financial statements can be found on
http://www.actelion.com.
For the three months period ended September 30, 2003, product sales equivalent to CHF 4.6 million (less respective cost of sales of CHF 0.463 million), have been reclassified to the three months period ended December 31, 2003 with no impact on full year 2003 product sales and cost of sales. The reason for the reclassification was the result of product dispatched before the end of September 2003, but was delayed en route and arrived only on the first day of October 2003 at the customer. The reclassification has had no impact on the audited 2003 full year financial statements.
Consistent quarter-on-quarter growth in Tracleer(r) sales
In the first nine months of 2004, Actelion had total net revenues of CHF 341.5 million (9 m 2003: CHF 209.1 m). On a quarter-to-quarter basis, net revenues increased by 11% percent to CHF 126.5 million (Q2 2004: 113.9 m).
Contract revenues for the first nine months of 2004 amounted to CHF 12.0 million (9 m 2003: 5.2 m). On a quarter-to-quarter basis, contract revenues were CHF 4.4 million (Q2 2004: 4.5 m).
Expanding market opportunities for Tracleer(r)
In the first nine months of 2004, Tracleer(r) sales were CHF 325.4 million (9 months 2003: CHF 203.7 m). On a quarter-to-quarter basis, Tracleer(r) revenues increased by 11 percent to CHF 120.4 million (Q2 2004: 108.0 m).
At the end of September 2004, Tracleer(r) was marketed in 18 countries worldwide, including almost all major pharmaceutical markets. In Japan, the Tracleer(r) registration dossier is still under review. The company expects the review process to conclude in 2004, with first revenues expected in 2005.
Actelion is also further pursuing market introduction of Tracleer(r) in the 10 new EU member states as well as in South-East Asia. In the period under review, Actelion has concluded for the latter a distribution agreement with PharmaLink, the marketing division of Zuellig Pharma Ltd.
Zavesca(r) sales continue momentum
Zavesca(r) sales in the approved indication type 1 Gaucher disease contributed in the first nine months of 2004 CHF 4.1 million to Actelion's revenue. (9 months 2003: CHF 0.3 m). On a quarter-to-quarter basis, Zavesca(r) revenues increased by 20 percent to CHF 1.8 million (Q2 2004: 1.5 m). Zavesca(r) is now available in 13 countries.
Additional clinical studies are under way to evaluate the potential use of Zavesca(r) in other lipid-storage diseases such as Late Onset Tay-Sachs disease, Type 3 Gaucher disease and Niemann-Pick Type C disease, for which currently no therapy exists.
Operating expenses reflect substantial efforts in both marketing and R&D
In the first nine months of 2004 operating expenses were CHF 277.6 million (9 m 2003: CHF 181.1 m). In Q3 2004, operating expenses were CHF 97.7 million (Q2 2004: CHF 98.6 m). This represents a slight decrease of 1% mainly due to seasonally reduced investment in marketing and advertising.
In the first nine months of 2004, marketing and advertising costs were CHF 69.9 million (9 m 2003: 57.1 m). In Q3 2004 marketing and advertising expenses were CHF 22.5 million. Compared to the previous quarter (Q2 2004: CHF 27.4 m), this represents a decrease of 18% due to the quiet congress season in the summer months.
In the first nine months of 2004 selling, general and administrative expenses amounted to CHF 70.1 million (9 m 2003: CHF 43.9 m). In Q3 2004 selling, general and administrative expenses were CHF 26.0 m, an increase of 17% compared to the previous quarter (Q2 2004: CHF 22.3 m) in line with the ongoing sales force optimization.
Research and Development cost increases reflect rapidly advancing pipeline
In the first nine months of 2004, research and development expenses were CHF 103.1 million (9 m 2003: CHF 56.9 m) including a CHF 5.0 million in-process R&D charge in Q2 2004.
In Q3 2004 research and development expenses were CHF 36.5 m, this represents an increase of 13% (Q2 2004: CHF 32.4 m) fully in line with our ongoing late stage clinical trial program.
In Q3 2004, Actelion achieved numerous clinical milestones, especially in relation to Tracleer(r) and tezosentan (Veletri(tm)).
In mid-September 2004, RAPIDS-2 (RAndomized, double-blind, Placebo-controlled, multi-center study to assess the effect of bosentan on healing and prevention of Ischemic Digital ulcers in patients with systemic Sclerosis) has been closed for enrollment. The study enrolled a total of 190 patients (enrollment target: 180 patients). These patients are now followed for up to 11 months, with final study results therefore expected in late 2005 or early 2006.
In late September 2004, the clinical program evaluating the safety and efficacy of bosentan (Tracleer(r)) in Idiopathic Pulmonary Fibrosis (BUILD-1: Bosentan Use in Interstitial Lung Disease) and the scleroderma-related form of Pulmonary Fibrosis (BUILD-2) have been closed for enrollment. BUILD-1 has enrolled 158 patients (enrollment target: 132) and BUILD-2 has enrolled 162 patients (enrollment target: 132). These patients are now followed for another 12 months, with final study results therefore expected in late 2005 or early 2006.
In early October 2004, Actelion also enrolled the first Class II PAH patient in the EARLY (Endothelin Antagonist tRial in miLdly sYmptomatic PAH patients) study. This clinical trial with Tracleer(r) is foreseen to recruit 170 patients. With patients being followed for at least six months, study results may become available in mid-2006. If successful, the data of this study would be submitted for regulatory review to potentially expand the existing labeling in the indication Pulmonary Arterial Hypertension.
In mid-October 2004, Actelion submitted raw data from more than 1'300 patients enrolled in the VERITAS (Value of Endothelin Receptor Inhibition with Tezosentan in Acute heart failure Study) program to the independent Drug Safety Monitoring Board (DSMB). The second futility analysis is expected to take place in early November 2004.
Actelion also strengthened its early-stage clinical pipeline in the previous months. In early September, the company commenced a Phase I clinical program with a small molecule (labeled Actelion-1).
In mid-October 2004, Actelion concluded enrollment for its Phase IIa program with palosuran, an orally available urotensin-II receptor antagonist. Palosuran, a first-in-class agent, is evaluated as a potential treatment option for kidney failure associated with diabetes (diabetic nephropathy). First study results are expected in mid-2005.
In addition, further preparations were made to initiate towards year-end a Phase IIb/III program with clazosentan, an i.v. endothelin receptor antagonist to be evaluated in vasospasm prevention following subarachnoid hemorrhage. Actelion is still in discussion with regulatory authorities on this matter.
Strong operating profit as a result of strong top-line growth
In the first nine months of 2004, a strong increase in sales revenues resulted in an operating profit of CHF 63.9 million (9 m 2003: CHF 28.0 m). Despite pronounced increase in R&D spending, Q3 2004 operating profit of CHF 28.8 million was 88 percent higher than the previous quarter (Q2 2004: CHF 15.3 m).
Non-operating items and cash
In the first nine months of 2004, the net profit of CHF 64.2 million (9 m 2003: 23.1 m) includes interest income of CHF 0.5 million, interest expense of CHF 0.4 million, a non-cash charge on the Convertible Bond of CHF 5.5 m, foreign currency gains of CHF 0.8 m and an income tax expense of CHF 4.8 m.
In Q3 2004, the net profit was CHF 25.1 m compared to CHF 11.3 m in the previous quarter.
On 30 September 2004, the company held cash and cash equivalents of CHF 273.7 million (30 June 2004: CHF 244.8 million).
For documentation purposes -- table Q3 2004 vs. Q2 2004
In CHF thousands Results Q3 Results Q2
2004 2004 Variance in %
Net Revenues 126'527 113'937 12'590 +11
Operating Expenses 97'723 98'606 -883 -1
Operating Profit/Loss 28'804 15'331 13'473 +88
Net Profit/Loss 25'105 11'330 13'775 +122
Basic EPS in CHF 1.14 0.52 0.62 +119
Cash & cash equivalents 273'727 244'831 28'896 +12
Actelion Member of the Board announces retirement
Fred Meyer has informed the company that he plans to resign his board membership functions by year-end 2004 upon reaching age 74. Rob Cawthorn, Chairman of the Board of Actelion, commented: "On behalf of all Actelion shareholders and employees, we would like to thank Fred for his distinguished service. His wide strategic and financial background has helped tremendously to steer the company towards becoming one of the leading global biopharmaceutical companies in only seven years of operations.
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 Australia, 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
Investor Contact Roland Haefeli +41 61 487 34 58
+1 650 624 6936
Media Contact Peter Engel +41 61 487 36 28
+1 650 624 6996
http://www.actelion.com
Conference Call
Actelion will host an Investor Conference Call and discussion/Q&A on Tuesday, 26 October 2004, 16.15 CET / 10.15 a.m. EST / 15.15 GMT
Dial: +41 (0)91 610 56 00 (Europe)
+1 866 291-4166 (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 on our website "Investors/Past Events".
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Actelion's financial calendar 2005 Date: Event: 24 February 2005 Q4 and FY 2004 financial results 14 April 2005 Annual General Meeting 28 April 2005 Q1 2005 financial results 28 July 2005 H1 2005 financial results 27 October 2005 9-month 2005 financial results