ALLSCHWIL/BASEL, Switzerland, July 28, 2005 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) (Other OTC:ALIOF) today announced its financial results for the first six months of 2005. With total net revenue for H1 2005 of CHF 296.2 million (H1 2004: CHF 215.0 m) and operating expenses of CHF 217.4 million (H1 2004: 179.9 m), the company reported an operating profit of CHF 78.8 million (H1 2004: CHF 35.1 m). The net profit for H1 2005 was CHF 65.9 million (H1 2004: CHF 39.0 m).
Basic earnings per share (EPS) for the first half of 2005 improved to CHF 2.96, compared to CHF 1.78 in H1 2004. The gross cash position as of 30 June 2005 was CHF 302.4 million (31 March 2005: CHF 293.4 m).
Jean-Paul Clozel, MD and Chief Executive Officer, commented: "I am very pleased about the continuing strong operating performance of Actelion which is mainly due to the outstanding achievements of our flagship product, Tracleer(r). During recent months Actelion has further strengthened Tracleer(r)'s market leadership position as the competitive situation is now clear for doctors and patients."
Andrew J. Oakley, Chief Financial Officer commented: "Results for the first half of 2005 were excellent as the company continues to advance in all areas. Tracleer(r) sales continued to grow across all markets and we now have a further platform for growth with first revenues in Japan."
Andrew J. Oakley continued: "We have now increased confidence in terms of sales in all of our markets and as such have revised our full year net revenue guidance to between 600 -- 615 million Swiss Francs. This also takes into account the increasing value of the US Dollar."
Financial result overview -- Table H1 2005 vs. H1 2004
In CHF thousands Result H1 2005 Result H1 2004 Variance
in %
Net Revenues 296,224 214,990 81,234 +38
Operating
Expenses 217,387 179,905 37,482 +21
Operating
Profit 78,837 35,085 43,752 +125
Net Profit 65,925 39,045 26,880 +69
Basic EPS
in CHF 2.96 1.78 1.18 +66
Diluted EPS
in CHF 2.85 1.69 1.16 +69
Cash & cash
equivalents 302,361 244,831 57,530 +23
The full financial statements can be found on http://www.actelion.com.
Strong top line growth
In the first six months of 2005, Actelion had total net revenue of CHF 296.2 million (H1 2004: CHF 215.0 m). On a quarter-to-quarter basis, net revenue increased by 2% to CHF 149.9 million (Q1 2005: CHF 146.4 m).
Contract revenues in H1 2005 amounted to CHF 8.2 million (H1 2004: CHF 7.7 m). On a quarter-to-quarter basis, contract revenues remained nearly unchanged with CHF 4.0 million (Q1 2005: 4.2 m).
For the Full Year 2005, Actelion now expects total net revenue to reach between CHF 600 and CHF 615 million, compared to between CHF 580 and CHF 600 million as previously guided at the end of Q1 2005.
A platform for future growth In H1 2005, Tracleer(r) sales were CHF 282.3 million (H1 2004: CHF 205.1 m). On a quarter-to-quarter basis, Tracleer(r) revenues increased by 2% to CHF 142.5 million (Q1 2005: CHF 139.8 m). Buying pattern variations continue to affect quarterly sales trends.
At the end of June 2005, Tracleer(r) was marketed in 22 countries worldwide, including all major pharmaceutical markets. In early April, the Japanese Authorities granted formal approval for Tracleer(r) in all forms of Pulmonary Arterial Hypertension (WHO class III and IV). Tracleer(r) has been commercially available in Japan since mid-June 2005, following the successful conclusion of reimbursement discussions.
Also in June 2005, Actelion signed a distribution agreement covering Tracleer(r) in Russia with Serono. Since mid July 2005, Tracleer(r) has also been commercially available in the Czech Republic.
Regulatory and/or reimbursement reviews are ongoing in many other countries, such as the remaining nine new EU member states, Brazil, Turkey as well as in several South East Asian countries.
In May 2005, data from almost 5,000 Tracleer(r)-treated patients were presented at the American Thoracic Society (ATS) meeting in San Diego. These data (the TRAcleer(r) eXcellence Post-Marketing Surveillance -- TRAX PMS - Program) represent the completion of the largest non-interventional study to date of patients treated with bosentan for PAH in daily medical practice. The long-term data confirmed the safety profile of Tracleer(r) as seen in phase III clinical trials and provided information on the combination of bosentan treatments with agents such as sildenafil or anticoagulants.
At the Annual European Congress of Rheumatology in June 2005, abstracts were presented showing the positive impact of Tracleer(r) in treating pulmonary arterial hypertension (PAH) in patients with systemic sclerosis (scleroderma).
Christian Chavy, President Business Operations, commented: "The impressive performance of Tracleer(r) sales can be seen across all countries. Our increased investment into an expanded sales force and in continuing medical education in selected key markets, has paid off and resulted in an improved diagnosis rate of PAH. We therefore intend to continue to expand our sales force and to increase physician and patient awareness in selected growth markets."
Zavesca(r) continues to add to top line Zavesca(r) sales contributed in the first half of 2005 CHF 5.8 million to Actelion's revenue. (H1 2004: CHF 2.3 m). On a quarter-to-quarter basis, Zavesca(r) revenues increased by 42% to CHF 3.4 million (Q1 2005: CHF 2.4 m). Zavesca(r) is commercially available in the United States and in most European markets.
Operating expenses in line with expansion of the business In H1 2005 total operating expenses including cost of goods sold were CHF 217.4 million (H1 2004: CHF 179.9 m). In Q2 2005 operating expenses were CHF 114.7 million. Compared to the previous quarter, this represents an increase of 12% (Q1 2005: CHF 102.7 m).
For the Full Year 2005, Actelion expects total operating expenses (including costs of goods sold) to reach between CHF 470 million and CHF 500 million, taking into account CHF 15 million "fair value accounting" of employee stock options according to FAS 123(R) as from 1 July 2005 onwards. Actelion does not benefit from the SEC granted delay of six months, as the FASB has ruled that this is only applicable for companies listed on a US stock exchange.
In H1 2005 research and development expenses were CHF 73.2 million (H1 2004: CHF 61.6 m). In Q2 2005 research and development expenses were CHF 41.2 m, this represents an increase of 29% (Q1 2005: CHF 32.0 m). Development expenses were driven by enrollment of patients into the CONSIOUS-I phase IIb/III study, evaluating clazosentan in vasospasm as consequence of subarachnoid hemorrhage, as well as other multiple clinical trial programs. Together with increasing pre-clinical research, R&D costs are expected to reach between CHF 170 million -- 180 million for the full year, in-line with previous guidance other than for provisions made due to FAS 123(R).
In H1 2005, marketing and advertising costs were CHF 56.7 million (H1 2004: CHF 47.4 m). In Q2 2005 marketing and advertising expenses were CHF 29.8 million. Compared to the previous quarter (Q1 2005: CHF 26.9 m), this represents an increase of 11%, which is in-line with our participation at multiple major medical congresses, as well as our ongoing increased educational effort in PAH.
In H1 2005 selling, general and administrative expenses amounted to CHF 57.9 million (H1 2004: CHF 44.1 m). In Q2 2005 selling, general and administrative expenses were CHF 29.0 m and remained virtually flat compared to the previous quarter (Q1 2005: CHF 28.9 m).
In the coming months, Actelion will selectively increase its Tracleer(r) sales force in key markets worldwide. Accordingly, in the second half of 2005, sales, general and administrative expenses together with marketing and advertising costs are expected to reach between CHF 240 -- 260 m for the full year, again in-line with previous guidance other than for provisions made due to FAS 123(R).
Strong operating profit as a result of strong top-line growth In H1 2005, a strong increase in sales revenues resulted in an operating profit of CHF 78.8 million (H1 2004: CHF 35.1 m). As a result of buying pattern variations affecting quarter-to quarter top-line revenues, R&D spending picking up from an artificial low and seasonally strong marketing spending, Q2 2005 operating profit of CHF 35.2 million was 19% lower than the previous quarter (Q1 2005: CHF 43.7 m).
For the Full Year 2005, Actelion now expects -- despite an additional non cash charge of CHF 15 million for FAS 123(r) -- that operating profit will reach between CHF 125 and 135 million, compared to previous guidance of CHF 120 and CHF 130 million that did not include any charges for "fair value accounting" of employee stock options.
Non-operating items and cash In H1 2005, the net profit of CHF 65.9 million (H1 2004: CHF 39.0 m) includes interest income of CHF 1.3 million, interest expense of CHF 0.02 million, a non-cash charge on the Convertible Bond of CHF 3.9 million, foreign currency losses of CHF 6.5 million and an income tax expense of CHF 3.8 million. In Q2 2005, the net profit was CHF 23.8 million compared to CHF 42.1 million in the previous quarter. On 30 June 2005, the company held cash and cash equivalents of CHF 302.4 million (31 March 2005: CHF 293.4 m).
Research and Development programs on track Actelion's Research and Development projects evaluating Tracleer(r), Zavesca(r), clazosentan, the undisclosed agent Actelion-1, the orexin receptor antagonist and other compounds in different indications are proceeding according to our expectations.
In May 2005, Actelion announced that preliminary efficacy data generated in the proof-of-concept program, testing its urotensin-II receptor antagonist, palosuran, in the indication diabetic nephropathy did not support the initiation of a full-fledged clinical development program at this point in time. There were no safety findings that would preclude further development in other indications. Actelion is currently analyzing the full data and will discuss the detailed findings with key medical experts in the field.
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). A total of 54 patients with WHO functional class III PAH participated. The results show that patients with bosentan treatment demonstrate a decrease in pulmonary vascular resistance and an improvement in exercise capacity without a worsening in oxygen saturation. Overall the bosentan safety and tolerability profile was comparable to that observed in previous placebo-controlled clinical trials in PAH with Tracleer(r). Actelion is currently analyzing the data in detail in view of discussing the information with regulatory authorities worldwide, and will make the full data set available through publication in a peer-reviewed journal and presentation at upcoming scientific meetings.
In July 2005 a Phase IIa/III study published in the July edition of the Journal of Neurosurgery suggested that clazosentan could reduce the number and severity of cases of vasospasm following aneurysmal subarachnoid haemorrhage (SAH).
Actelion will give a full update on its current R&D projects at its forthcoming R&D Day on 8th of September 2005 in Allschwil (Switzerland) and on 9th of September 2005 in New York (USA).
For documentation purposes -- table Q1 2005 vs. Q2 2005
In CHF thousands Results Q2 2005 Results Q1 2005 Variance
in %
Net Revenues 149'871 146'353 3'518 +2
Operating
Expenses 114'700 102'687 12'013 +12
Operating
Profit 35'171 43'666 -8'495 -19
Net Profit 23'815 42'110 -18295 -43
Basic EPS
in CHF 1.07 1.90 -0.83 -44
Cash &
cash
equivalents 302'361 293'367 8'994 +3
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, 28 July 2005, 15.30 CET / 09.30 a.m. EST / 14.30 BST.
Dial: +41 (0) 91 610 56 00 (Europe)
+1 (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 August 2005 it will be stored under Investors/Past Events.