ALLSCHWIL, Switzerland, Oct. 19, 2006 (PRIMEZONE) -- Actelion Ltd (SWX:ATLN) today announced its financial results for the first nine months of 2006. With total net revenues for the first nine months of 2006 of CHF 684.3 million (9 m 2005: CHF 477.1 m) and operating expenses of CHF 487.5 million (9 m 2005: 351.0 m), the company reported an operating profit of CHF 196.8 million (9 m 2005: CHF 126.1 m). The net profit for the first nine months of 2006 was CHF 171.8 million (9 m 2005 CHF 101.3 m).
Basic earnings per share (EPS) for the first nine months of 2006 improved to CHF 7.60, compared to CHF 4.55 in the first nine months of 2005. In the first nine months of 2006 Actelion generated net cash flow from operating activities of CHF 271.6 million (9 m 2005: CHF 90.2 m). Cash, cash equivalents and short-term deposits and marketable securities as of September 30, 2006 were CHF 636.3 million (June 30, 2006: CHF 448.1 m).
Jean-Paul Clozel, MD and Chief Executive Officer, commented: "In the first nine months of 2006, Actelion has been able to focus on operational performance in the market place as well as expanding our efforts in research and development."
He continued: "In the market place, we have been very successful in increasing awareness about PAH and the unprecedented treatment option provided by Tracleer(r), our dual endothelin receptor antagonist first introduced in the United States at the end of 2001. Actelion is committed to further advance and lead the PAH field, with numerous clinical and other programs already ongoing or soon to start."
Jean-Paul Clozel added: "Our nine years of continuing and expanding investment in other potential medical breakthroughs could result in five different compounds in the final stage of clinical development in 2007, next to an already large lifecycle management program."
Andrew J. Oakley, Chief Financial Officer commented: "Our financial results continue to be outstanding as Tracleer(r) sales continued to grow across all markets. I am especially pleased that we have been able to increase net profit by no less than 70 percent compared to the same period last year. With October launches in South Korea and China, we are continuing to expand our revenue base."
Andrew J. Oakley continued: "The strong performance of Actelion year to date allows us to revise our full year net revenue guidance upwards, from between 880 to 910 to between 930 and 940 million Swiss Francs -- unforeseen events excluded. With expenditures as forecasted, Actelion is also revising its operating profit guidance upwards, from between 215 to 230 million to between 240 and 260 million Swiss Francs for the full year 2006."
Financial result overview -- Table 9 months 2006 vs. 9 months 2005
Result Result
In CHF thousands 9 months 9 months Variance in %
2006 2005
Net Revenues 684,279 477,056 207,223 +43
Operating Expenses(a) 487,499(b) 350,982(a) 136,517 +39
Operating Profit 196,780 126,074 70,706 +56
Net Profit 171,792 101,253 70,539 +70
Basic EPS in CHF 7.60 4.55 3.05 +67
Diluted EPS in CHF 7.37 4.48 2.89 +65
Net cash from operations 271,630 90,220 181,410 +201
(a) includes non-cash charge for employee stock options of CHF 7.4
million
(b) includes non-cash charge for employee stock options of CHF
24.9 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 2006, Actelion had total net revenues of CHF 684.3 million (9 m 2005: CHF 477.1 m). On a quarter-to-quarter basis, net revenues increased by 9 percent to CHF 247.2 million (Q2 2006: CHF 226.5 m).
Contract revenues for the first nine months of 2006 amounted to CHF 14.5 million (9 m 2005: CHF 12.1 m). On a quarter-to-quarter basis, contract revenues increased to CHF 6.8 million (Q2 2006: CHF 3.8 m).
For the Full Year 2006, Actelion now expects total net revenue to reach between CHF 930 and CHF 940 million, compared to between CHF 880 and CHF 910 million as previously guided with the H1 2006 results.
Tracleer(r) sales growth continuing
In the first nine months of 2006, Tracleer(r) sales were CHF 651.9 million (9 months 2005: CHF 455.1 m). On a quarter-to-quarter basis, Tracleer(r) revenues increased by 8 percent to CHF 234.0 million (Q2 2006: 216.5 m). This increase may partially be attributed to buying pattern variations, similar to those seen in previous quarters.
At the end of September 2006, Tracleer(r) was commercially available in 35 countries worldwide, including all major pharmaceutical markets. In October 2006, Tracleer(r) is being introduced in China and, together with Handok, in South Korea. Regulatory and/or reimbursement reviews are ongoing in many other countries, such as some new EU member states as well as in some South East Asian countries.
In many territories, regulatory review is ongoing regarding the inclusion of data from BREATHE-4 and BREATHE-5 studies that included patients with PAH associated with HIV and PAH associated with congenital heart disease (CHD) respectively. In late September, the European regulatory body (EMEA) issued a positive opinion on the application, expected to result in the inclusion of the findings in the EU prescribing information by year-end.
At the World Congress of Cardiology in Barcelona in early September, Actelion launched the first-ever global PAH awareness campaign to further increase disease awareness amongst healthcare professionals and increase the number of patients appropriately diagnosed and treated. At the same time, the educational website www.pah-info.com was launched to provide the medical community with up-to-date information on the disease and its diagnosis.
Steady growth for Zavesca(r) sales
Zavesca(r) sales in the approved indication type 1 Gaucher disease contributed in the first nine months of 2006 CHF 18.0 million (9 months 2005: CHF 9.8 m). On a quarter-to-quarter basis, Zavesca(r) revenues increased by approximately 3 percent to CHF 6.4 million (Q2 2006: 6.2 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 2006 operating expenses were CHF 487.5 million (9 m 2005: CHF 351.0 m). In Q3 2006, operating expenses were CHF 170.7 million. Compared to the previous quarter, this represents an increase of 2 percent (Q2 2006: CHF 167.3 m).
For the Full Year 2006, Actelion expects total operating expenses to reach between CHF 675 million and CHF 750 million, including a total non-cash charge of approximately CHF 30 million for stock-based compensation.
In the first nine months of 2006, research and development expenses were CHF 155.1 million (9 m 2005: CHF 121.2 m). In Q3 2006 research and development expenses were CHF 54.1 million, this represents an increase of 1 percent (Q2 2006: CHF 53.3 m).
In the first nine months of 2006, marketing and advertising expenses were CHF 129.4 million (9 m 2005: 88.6 m). In Q3 2006 marketing and advertising expenses were CHF 43.5 million, a decrease of 3 percent compared to the previous quarter (Q2 2006: CHF 44.8 m).
In the first nine months of 2006, selling, general and administrative expenses amounted to CHF 133.2 million (9 m 2005: CHF 92.7 m). In Q3 2006, selling, general and administrative expenses were CHF 48.6 million, an increase of 7 percent compared to the previous quarter (Q2 2006: CHF 45.3 m).
Strong operating profit
In the first nine months of 2006, a strong increase in sales revenues resulted in an operating profit of CHF 196.8 million (9 m 2005: CHF 126.1 m).
Q3 2006 operating profit of CHF 76.5 million was 29 percent higher than the previous quarter (Q2 2006: CHF 59.3 m).
For the Full Year 2006, Actelion now expects that operating profit will reach between CHF 240 and 260 million, compared to previous guidance of CHF 215 and CHF 230 million.
Non-operating items and cash
In the first nine months of 2006, the net profit of CHF 171.8 million (9 m 2005: CHF 101.3 m) includes interest income of CHF 4.6 million, interest expense of CHF 0.05 million, a non-cash charge on the Convertible Bond of CHF 6.1 million, foreign currency gains of CHF 6.6 million and an income tax expense of CHF 30.0 million.
In Q3 2006, the net profit was CHF 66.8 million compared to CHF 51.3 million in the previous quarter.
In the first nine months of 2006, Actelion generated net cash flow from operations of CHF 271.6 million (9 m 2005: CHF 90.2 m). Cash and cash equivalents, short-term deposits and marketable securities as of September 30, 2006 were CHF 636.3 million (June 30, 2006: CHF 448.1 m).
Research and Development programs on track
Actelion provided a full update on its current R&D projects in July. All research and development programs are on track.
In early October 2006, Actelion presented the full data analysis of dose-finding study CONSCIOUS-1 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage). The study reported significant reduction of cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage in a dose-dependent fashion. Post-hoc blinded central assessment showed a dose-dependent trend towards improved morbidity/mortality. Discussions with regulatory authorities on the appropriate pivotal trial design are forthcoming.
Actelion will provide a full and complete update and all its projects at the upcoming Research and Development day, to be held at the Actelion premises on February 22, 2007. At the same occasion, Actelion will also report its Full Year result 2006.
By the 22nd of February 2007, Actelion expects to provide individual updates on
-- Actelion-1, an undisclosed cardiovascular agent in Phase IIa
-- EARLY, a Phase III study evaluating safety and efficacy of bosentan
(Tracleer(r)) in WHO class 2 PAH patients
For documentation purposes -- table Q3 2006 vs. Q2 2006
In CHF thousands Results Q3 Results Q2 Variance in %
2006 2006
Net Revenues 247,180 226,545 20,635 +9
Operating Expenses 170,679 167,274 3,405 +2
Operating Profit 76,501 59,271 17,230 +29
Net Profit 66,804 51,322 15,482 +30
Basic EPS in CHF 2.95 2.27 0.68 +30
Net cash from operations 194,049 43,203 150,846 +349
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, October 19, 2006, 15.30 CEST / 14.30 BST / 9.30 a.m. EDT.
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 20 November 2005 it will be stored under Investors/Past Events.
Actelion's financial calendar 2007
Date: Event: February 22, 2007 Full year 2006 results, R&D day April 19, 2007 3-month 2007 financial results July 19, 2007 6-month 2007 financial results October 18, 2007 9-month 2007 financial results