ALLSCHWIL, Switzerland, Oct. 19, 2005 (PRIMEZONE) -- Due to a transposition error, the Actelion 9-months 2005 press release contained two errors in terms of Tracleer sales numbers. Tracleer sales for the first 9 months of 2005 where CHF 455.1 million (not 455.7) and for Q3 2005 CHF 172.9 million (not 173.5), a QoQ change of 21%. All other numbers are unchanged. Please find hereafter the corrected version.
Actelion Ltd (SWX:ATLN) today announced its financial results for the first nine months of 2005. With total net revenues for the first nine months of 2005 of CHF 477.1 million (9 m 2004: CHF 341.5 m) and operating expenses of CHF 351.0 million (9 m 2004: 277.6 m), the company reported an operating profit of CHF 126.1 million (9 m 2004: CHF 63.9 m). The net profit for the first nine months of 2005 was CHF 103.8 million (9 m 2004: CHF 64.2 m).
Basic earnings per share (EPS) for the first nine months of 2005 improved to CHF 4.66, compared to CHF 2.92 in the first nine months of 2004. In the first nine months of 2005 Actelion generated net cash flow from operating activities of CHF 92.1 million (9 m 2004: CHF 61.9 m). Cash, cash equivalents and short-term deposits as of 30 September 2005 were CHF 344.0 million (30 June 2005: CHF 302.4 million).
Jean-Paul Clozel, MD and Chief Executive Officer, commented: "I am delighted with our overall performance for the first nine months of 2005. Actelion has been successful in growing the pulmonary arterial hypertension (PAH) market more rapidly than we expected, with physicians becoming even more aware of the benefits of diagnosis and treatment with our dual endothelin receptor antagonist Tracleer(r). Actelion has committed additional resources to further increase its educational and clinical efforts in the PAH community."
Jean-Paul Clozel added: "Actelion has also made substantial advances in implementing its long-term strategy of growing above and beyond Tracleer(r) in PAH. Our pre-clinical and clinical programs are making rapid progress. Line-extension studies for our two marketed products Tracleer(r) (bosentan) and Zavesca(r) (miglustat) will report data before year-end. Over the coming 18 months, Actelion also expects important clinical results from several pipeline projects with the potential to radically improve treatment of various diseases."
Andrew J. Oakley, Chief Financial Officer, commented: "Financial results for the first nine months of 2005 were outstanding as Tracleer(r) sales continued to grow across all markets. In mid-June 2005, commercial sales of Tracleer(r) also started in Japan. We expect this market to provide significant growth in 2006. Our cost base continued to increase in line with both our expectations and the expansion of our business activities."
Andrew J. Oakley continued: "Considering our continuing success with Tracleer(r) in PAH, we have revised our full year net revenue guidance upwards, from between 600 to 615 to between 640 and 655 million Swiss Francs -- unforeseen events excluded. With no changes to previously forecasted expenditures, Actelion could report an operating profit of between 140 and 155 million Swiss Francs for the full year 2005."
Financial result overview - Table 9 months 2005 vs. 9 months 2004
In CHF thousands Result 9 Result 9 Variance in %
months 2005 months 2004
Net Revenues 477,056 341,517 135,539 +40
Operating Expenses(a) 350,982(a) 277,628 73,354 +26
Operating Profit 126,074 63,889 62,185 +97
Net Profit 103,793 64,150 39,643 +62
Basic EPS in CHF 4.66 2.92 1.74 +60
Diluted EPS in CHF 4.49 2.78 1.71 +62
Net cash from operations 92,080 61'922 30,158 +49
(a) includes non-cash charge for employee stock options of
CHF 7.4 million
The full financial statements can be found on http://www.actelion.com.
Outstanding growth of total net revenues
In the first nine months of 2005, Actelion had total net revenues of CHF 477.1 million (9 m 2004: CHF 341.5 m). On a quarter-to-quarter basis, net revenues increased by 21% percent to CHF 180.8 million (Q2 2005: CHF 149.9 m).
Contract revenues for the first nine months of 2005 amounted to CHF 12.1 million (9 m 2004: CHF 12.0 m). On a quarter-to-quarter basis, contract revenues were CHF 3.9 million (Q2 2005: CHF 4.0 m).
For the Full Year 2005, Actelion now expects total net revenue to reach between CHF 640 and CHF 655 million, compared to between CHF 600 and CHF 615 million as previously guided with the H1 2005 results.
Stronger than expected Tracleer(r) sales
In the first nine months of 2005, Tracleer(r) sales were CHF 455.1 million (9 months 2004: CHF 325.4 m). On a quarter-to-quarter basis, Tracleer(r) revenues increased by 21 percent to CHF 172.9 million (Q2 2005: 142.5 m). This increase may partially be attributed to buying pattern variations, similar to those seen in previous quarters.
At the end of September 2005, Tracleer(r) was approved in 34 countries worldwide, including all major pharmaceutical markets. Since mid-July 2005, Tracleer(r) has also been commercially available in the Czech Republic. In July 2005, Actelion Pharmaceuticals Korea signed a distribution agreement for Tracleer(r) in Korea with Handok Pharmaceuticals, a Korean public company.
Regulatory and/or reimbursement reviews are ongoing in many other countries, such as the remaining nine new EU member states as well as in some South East Asian countries.
Further data demonstrates unique clinical features of Tracleer(r) (bosentan)
In mid-July 2005, Actelion reported top-line results of BREATHE-5, the first ever placebo-controlled study conducted in patients with Eisenmenger's syndrome, a severe form of Congenital Heart Disease (CHD). The results showed that bosentan treatment decreased pulmonary vascular resistance and improved exercise capacity without a worsening in oxygen saturation. Discussions with regulatory authorities on appropriately labeling these findings are forthcoming. A first scientific presentation will be at CHEST in Montreal at the beginning of November 2005.
In mid-August 2005, the Journal of the American College of Cardiology (JACC) published a new study that investigated the long-term outcome of children with pulmonary arterial hypertension (PAH) treated with the bosentan with or without concomitant prostanoid therapy. The authors concluded that bosentan, with or without concomitant prostanoid therapy, in this study was shown to be efficacious for the treatment of PAH in children. In addition, this study also indicated that the safety profile appears similar to that in adult PAH patients.
In early September 2005, Actelion presented two abstracts at the European Society of Cardiology (ESC) conference, which confirmed the long-term safety profile of bosentan in treating PAH. The abstracts included data focusing on PAH associated with chronic thromboembolic pulmonary hypertension (CTEPH) as well as data outlining the safety profile of bosentan in PAH related to congenital heart disease (CHD).
In early August 2005, Actelion announced the preliminary result of a double-blind, placebo-controlled, randomized, multi-center, 190-patient Phase III study, RAPIDS-2, with bosentan in systemic sclerosis patients suffering from digital ulceration. Preliminary analyses indicated that the co-primary endpoint of reduction in the occurrence of new digital ulcers during the 6-month treatment period was statistically significant. This result confirmed the positive findings from an earlier trial, RAPIDS-1. Actelion is currently analyzing data for presentation to regulatory authorities. A first scientific presentation will be at ACR in San Diego in mid-November 2005.
Zavesca(r) sales continue momentum
Zavesca(r) sales in the approved indication type 1 Gaucher disease contributed in the first nine months of 2005 CHF 9.8 million (9 months 2004: CHF 4.1 m). On a quarter-to-quarter basis, Zavesca(r) revenues increased by 19 percent to CHF 4.1 million (Q2 2005: 3.4 m). Zavesca(r) is commercially available in the United States and in most European markets.
Operating expenses reflect substantial efforts in both marketing and R&D
In the first nine months of 2005 operating expenses were CHF 351.0 million (9 m 2004: CHF 277.6 m). In Q3 2005, operating expenses were CHF 133.6 million. Compared to the previous quarter, this represents an increase of 17% (Q2 2005: CHF 114.7 m). This increase is partially the result of a non-cash charge of CHF 6.8 million for stock-based compensation in Q3 2005.
For the Full Year 2005, Actelion expects total operating expenses to reach between CHF 485 million and CHF 500 million, including a total non-cash charge of approximately CHF 15 million for stock-based compensation.
In the first nine months of 2005, research and development expenses were CHF 121.2 million (9 m 2004: CHF 98.1 m).
In Q3 2005 research and development expenses were CHF 48.0 million. This represents an increase of 17% (Q2 2005: CHF 41.2 m) and includes a CHF 2.3 million charge for stock-based compensation.
Increased development expenses were mainly driven by faster than expected enrollment of patients into the CONSCIOUS-1 phase IIb/III study, evaluating clazosentan in vasospasm as consequence of subarachnoid hemorrhage. Enrollment is expected to be completed before year-end.
Interest in clazosentan was supported by Phase IIa study publication in the July 2005 edition of the Journal of Neurosurgery suggesting that clazosentan could reduce the number and severity of cases of vasospasm following aneurysmal subarachnoid haemorrhage (SAH).
In the first nine months of 2005, marketing and advertising expenses were CHF 88.6 million (9 m 2004: 69.9 m).
In Q3 2005 marketing and advertising expenses were CHF 31.9 million, an increase of 7% compared to the previous quarter (Q2 2005: CHF 29.8 m), which also includes a CHF 1.8 million charge for stock-based compensation.
In the first nine months of 2005 selling, general and administrative expenses amounted to CHF 92.7 million (9 m 2004: CHF 70.1 m).
In Q3 2005 selling, general and administrative expenses were CHF 34.8 million, an increase of 20% compared to the previous quarter (Q2 2005: CHF 29.0 m), including a CHF 2.7 million charge for stock-based compensation. The increase is in line with the increase of sales force headcount and related sales-based remuneration.
Strong operating profit
In the first nine months of 2005, a strong increase in sales revenues resulted in an operating profit of CHF 126.1 million (9 m 2004: CHF 63.9 m). Despite a CHF 6.8 million charge for stock-based compensation, Q3 2005 operating profit of CHF 47.2 million was 34 percent higher than the previous quarter (Q2 2005: CHF 35.2 m).
For the Full Year 2005, Actelion now expects that operating profit will reach between CHF 140 and 155 million, compared to previous guidance of CHF 125 and CHF 135 million.
Non-operating items and cash
In the first nine months of 2005, the net profit of CHF 103.8 million (9 m 2004: CHF 64.2 m) includes interest income of CHF 1.9 million, interest expense of CHF 0.04 million, a non-cash charge on the Convertible Bond of CHF 5.8 million, foreign currency losses of CHF 7.6 million and an income tax expense of CHF 10.7 million.
In Q3 2005, the net profit was CHF 37.9 million compared to CHF 23.8 million in the previous quarter.
In the first nine months of 2005 Actelion generated net cash flow from operations of CHF 92.1 million (9 m 2004: CHF 61.9 m). Cash and cash equivalents and short-term deposits as of 30 September 2005 were CHF 344.0 million (30 June 2005: CHF 302.4 million).
Research and Development programs on track
Actelion provided a full update on its current R&D projects at its recent R&D Day on 8th of September 2005. All research and development programs are on track:
-- Before the end of the year 2005, the company expects the results
from the BUILD program evaluating the safety and efficacy of
bosentan in two forms of Pulmonary Fibrosis, idiopathic pulmonary
fibrosis (BUILD-1) and pulmonary fibrosis related to systemic
sclerosis (BUILD-2).
-- Before the end of the year 2005, the company also expects the
results from three clinical studies evaluating the safety and
efficacy of miglustat in rare lysosomal storage disorders
characterized by neurological deficiencies (type 3 Gaucher
disease, Nieman-Pick disease and late-onset Tay Sachs).
-- The company announced that it is finalizing preparations to
commence the evaluation of safety and efficacy of bosentan in PAH
patients in combination with sildenafil. The large-scale COMPASS
program will evaluate both hemodynamic benefits as well as
effects on mortality/morbidity of the combination.
-- The company provided detailed background on the CONSCIOUS
program, evaluating the safety and efficacy of clazosentan, an
intravenous endothelin receptor antagonist in development for the
prevention of vasospasm following sub-arachnoid hemorrhage (SAH).
-- The company described the early clinical development of
Actelion's Orexin Receptor antagonist. Preliminary analysis of
the ongoing Phase I program indicated that the compound has the
pharmacokinetic profile necessary for a drug to be evaluated as a
sleep quality improver.
-- Actelion announced that it has commenced full pre-clinical
development of a novel, orally available immunomodulator. The
Actelion S1P1 agonist was well tolerated and efficacious in pre-
clinical models of autoimmune diseases, and demonstrated
appropriate modulation of the immune system.
-- The company provided background on the progress made in the
ongoing Global Actelion Merck Renin Inhibitor Alliance that had
selected a first highly bioavailable renin inhibitor for full
pre-clinical development in the spring of 2005.
-- Actelion disclosed that it has a broad research program in the
field of antibacterials focusing on fighting resistant bacterial
pathogens through novel mechanisms of action.
For documentation purposes - table Q3 2005 vs. Q2 2005
In CHF thousands Results Q3 Results Q2 Variance in %
2005 2005
Net Revenues 180,832 149,871 30,961 +21
Operating Expenses 133,595(a) 114,700 18,895 +17
Operating Profit 47,237 35,171 12,066 +34
Net Profit 37,868 23,815 14,053 +59
Basic EPS in CHF 1.70 1.07 0.63 +59
Net cash from operations 43,036 21,744 21,292 +98
(a) Includes stock based compensation as follows:
In CHF thousands Occurred in Q3 2005
Research and development 2,261
Marketing and advertising 1,831
Selling, general and administrative 2,723
Total 6,815
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, Japan as well as Canada, Australia 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 Thursday, 20 October 2005, 16.30 CET / 15.30 BST / 10.30 a.m. EST
Dial: +41 (0) 91 610 56 00 (Europe)
+1 (1) 866 291 41 66 (U.S.)
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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 20 November 2005 it will be stored under Investors/Past Events.
Actelion's financial calendar 2006 Date: Event: 23 February 2006 Q4 and FY 2005 financial results 10 April 2006 Annual General Meeting 20 April 2006 Q1 2006 financial results 20 July 2006 H1 2006 financial results 19 October 2006 9-month 2006 financial results