ALLSCHWIL/BASEL, SWITZERLAND – 18 October 2007 – Actelion Ltd (SWX: ATLN)
today announced its financial results for the first nine months of 2007. With total net revenues for the first nine months of 2007 of CHF 946.4 million (9 m 2006: CHF 684.3 m) and operating expenses of CHF 906.0 million (9 m 2006: 487.5 m) – including a one-time non-cash In-Process Research and Development (IPRD) charge of CHF 224.8 million incurred in the first quarter related to the acquisition of CoTherix - the company reported an operating profit of CHF 40.4 million (9 m 2006: CHF 196.8 m). The net profit for the first nine months of 2007 was CHF 36.1 million (9 m 2006 CHF 171.8 m).
To better measure and compare operating performance over time, Actelion continues to report non-GAAP Cash-EBIT (Operating Income excluding non-cash charges such as In-Process R&D, charges related to employee stock options under FAS 123R, as well as non-cash depreciation and amortization charges). In the first nine months of 2007, Actelion achieved a Cash-EBIT of CHF 349.0 million, an increase of 48 percent compared to the same period in 2006.
Fully diluted earnings per share (EPS), on a US GAAP basis, for the first nine months of 2007 were CHF 0.29, compared to CHF 1.47 in the first nine months of 2006.
Jean-Paul Clozel, MD and Chief Executive Officer, commented: “Actelion continues to grow both product revenues and pipeline. In view of the recent market introduction of an additional PAH treatment option in the United States, I am pleased to observe that PAH physicians continue to view Tracleer as the best documented and best supported endothelin receptor antagonist. I am confident that Tracleer will remain the PAH drug of choice. Together with the expected label expansion to cover the use in patients with less advanced PAH disease, I expect our PAH product revenues to continue to grow, but naturally at a lower rate than in the last five years.”
Jean-Paul Clozel concluded: “Actelion continues to expand its research and development pipeline. In addition to Phase III programs with bosentan, clazosentan, tezosentan and Actelion-1, we are accelerating our efforts in the field of sleep medicine. The recent data presentation of almorexant has raised substantial interest in the scientific community. With their support, Actelion is currently conducting numerous additional safety and efficacy studies while at the same time preparing for the Phase III program, scheduled for initiation by year-end.”
Andrew J. Oakley, Chief Financial Officer commented: "In the first nine months of 2007, Actelion has continued to perform in-line with our strategy, growing both product sales and R&D investment. With strong cash generation, Actelion is well prepared to finance the ongoing expansion of its R&D effort.”
Andrew J. Oakley added: “Despite a negative currency impact in Q3 that, together with buying pattern variations, resulted in a negative quarter-on-quarter revenue variance, I can reiterate our previous guidance. Unforeseen events excluded, I expect product revenues to reach between 1.275 and 1.315 billion Swiss Francs and a Cash EBIT of between 430 and 460 million Swiss Francs.”
Financial result overview – Table 9 months 2007 vs. 9 months 2006
In CHF thousands | Result 9 months 2007 | Result 9 months 2006 | Variance | in % |
Net Revenues | 946’449 | 684’279 | 262’170 | 38 |
Operating Expenses* | 906’020 | 487’499 | 418’521 | 86 |
Operating Income | 40’429 | 196’780 | (156’351) | (79) |
Cash EBIT | 348’983 | 236’006 | 112’977 | 48 |
Net Income | 36’133 | 171’792 | (135’659) | (79) |
Diluted EPS in CHF | 0.29 | 1.47 | (1.18) | (80) |
No of shares in calculation | 125’150 | 120’725 | na | na |
* includes IPRD charge of CHF 224.8 million incurred in the first quarter related to the acquisition of CoTherix
The full financial statements can be found on http://www.actelion.com.
Continued growth of total net revenues
In the first nine months of 2007, Actelion had total net revenues of CHF 946.4 million
(9 m 2006: CHF 684.3 m), an increase of 38 percent compared to the same period a year ago. On a quarter to quarter basis, net revenues decreased by 5 percent to CHF 320.1 million. Contract revenues for the first nine months of 2007 amounted to CHF 19.3 million (9 m 2006: CHF 14.5 m).
Tracleer® sales
In the first nine months of 2007, Tracleer® (bosentan) sales were CHF 846.5 million (9 months 2006: CHF 651.9 m), an increase of 30 percent compared to the same period last year. On a quarter-to-quarter basis, Tracleer® revenues decreased by 4 percent to CHF 286.6 million (Q2 2007: 299.5 m). This decrease can be attributed to buying pattern variations, similar to those seen in previous quarters. In addition, Tracleer sales were negatively affected by a weakening US Dollar.
At the end of September 2007, Tracleer® was commercially available in over 35 countries worldwide, including all major pharmaceutical markets. In the third quarter of 2007, Tracleer® became commercially available in Chile, Columbia and Venezuela. Further market introductions in Latin America are forthcoming in the coming quarters.
Early in Q3 2007, Actelion submitted to healthcare authorities worldwide the necessary documentation to apply for an indication extension with the EARLY study, in which Tracleer® achieved a significant decrease in the rate of clinical worsening at six months in PAH patients diagnosed with mild symptoms (WHO Class II). This data was also presented at the European Society of Cardiology and the European Society of Rheumatology.
Christian Chavy, President Business Operations, commented: “I am very pleased with the current trends in the PAH marketplace. While another PAH therapeutic option is now available in the United States, I believe that Tracleer has unique advantages, such as a proven long-term efficacy and safety profile and the support provided to prescribing physicians by a highly committed and experienced staff. All these features will ensure that our dual endothelin receptor antagonist rem a i ns the drug of choice when initiating therapy in PAH.”
Christian Chavy concluded: “The EARLY data has been very favorably received by the medical community. With further data presentations ahead at both CHEST and AHA and data review now initiated with regulatory authorities worldwide, I expect both a further strengthening of our competitive profile as well as an increased interest in early diagnosis and treatment for this severe cardiopulmonary disease.”
In the first nine months of 2007, Ventavis® (iloprost) sales were CHF 62.3 million (pro-forma), of which 54.8 million are actually recorded in Actelion’s profit and loss statement, the remainder having occurred before the acquisition of CoTherix on 9 January 2007. In the same period of last year, CoTherix achieved Ventavis (pro-forma) net sales of USD 45.8 million.
In early Q4 2007, Actelion has launched – next to its existing strong educational outreach to physicians - additional patient support programs and convenience improvements for the current Ventavis device. Accordingly, the company expects Ventavis growth to accelerate over time.
Zavesca® (miglustat) sales - approved for the treatment of type 1 Gaucher disease - contributed in the first nine months of 2007 CHF 25.8 million (9 months 2006: CHF 18.0 m). On a quarter-to-quarter basis, Zavesca® revenues decreased slightly to CHF 9.0 million (Q2 2007: 9.4 m). Zavesca® is commercially available in the United States and in most European markets.
In late Q3 2007, Actelion initiated a Phase IIa proof-of-concept clinical study with miglustat in Cystic Fibrosis (CF). The proof-of-concept clinical study has been designed as a single center, double-blind, randomized, placebo-controlled, crossover study in 25 patients affected by a specific CF mutation (delF508). Results are expected late in 2008.
Operating expenses
In the first nine months of 2007 operating expenses were CHF 906.0 million, including an In-Process Research and Development (IPRD) charge related to the acquisition of CoTherix of CHF 224.8 million incurred in the first quarter (9 m 2006: CHF 487.5 m).
In the first nine months of 2007, research and development expenses were CHF 210.0 million (9 m 2006: CHF 155.1 m). The increase is a result of ongoing investments into a rapidly expanding pipeline, with five different molecules expected to be in Phase III by year-end, 10 compounds in Clinical development and a rapidly expanding portfolio of pre-clinical projects.
In the first nine months of 2007, marketing and advertising expenses were CHF 164.6 million (9 m 2006: 129.4 m). The increase is the result of ongoing investments to strengthening product sales in all territories worldwide, focusing especially in the PAH area on both education and the generation of additional clinical data sets, such as combination data.
In the first nine months of 2007, selling, general and administrative expenses amounted to CHF 192.4 million (9 m 2006: CHF 133.2 m). Actelion continues to increase its investment into a global infrastructure to support long-term growth for its existing products as well as ensuring that future products can be launched efficiently, either by Actelion alone, or with its partners.
Operating profit
In the first nine months of 2007, Actelion’s operating profit was CHF 40.4 million (9 m 2006: CHF 196.8 m). Cash EBIT for the same period amounted to CHF 349.0 million (9 m 2006: CHF 236.0 m), an increase of 48 percent. Compared to Q2 2007, cash EBIT decreased by 9 percent, again influenced by buying patterns affecting the top line.
Net Profit
In the first nine months of 2007, the net profit of CHF 36.1million (9 m 2006: CHF 171.8 m) includes interest income of CHF 13.9 million, interest expense of CHF 0.09 million, a non-cash charge on the Convertible Bond of CHF 3.7 m illion, foreign currency gains of CHF 11.4 million and an income tax expense of CHF 25.8 million.
Cash and cash flow
In the first nine months of 2007, Actelion generated net cash flow from operations of
CHF 252.6 million (9 m 2006: CHF 268.7 m).
For documentation purposes – table Q3 2007 vs. Q2 2007
In CHF thousands | Results Q3 2007 | Results Q2 2007 | Variance | in % |
Net Revenues | 320’098 | 335’912 | (15’814) | (5) |
Operating Expenses | 228’873 | 235’235 | (6’362) | (3) |
- Research and Development | 74’817 | 69’453 | 5’364 | 8 |
- Marketing and Advertising | 52’320 | 59’702 | (7’382) | (12) |
- Selling, General and Admin. | 61’716 | 66’183 | (4’467) | (7) |
Operating Income | 91’225 | 100’677 | (9’452) | (9) |
Cash EBIT | 117’998 | 129’697 | (11’699) | (9) |
Net Income | 89’086 | 97’045 | (7’959) | (8) |
Diluted EPS in CHF | 0.70 | 0.77 | (0.07) | (9) |
No of shares in calculation | 126’428 | 125’717 | na | na |
Actelion News flow until Q1 2008
- Actelion-1: Initiation of Phase III before year-end 2007
- Almorexant: Initiation of Phase III at the end of 2007
- Bosentan in Metastatic Melanoma: Top-Line results of proof-of-concept study before year-end 2007
- Clazosentan in a SAH: Initiation of Phase III before year-end 2007
- Renin Inhibitor (with Merck): Go/no-go of Phase II before year-end 2007
- S1P1 agonist (with Roche): Go/no-go of Phase II Q 4 2007 / Q1 2008
- FY 2007 results including pipeline update 21 February 2008
Actelion Ltd
Actelion Ltd is a biopharmaceutical company with its corporate headqua rters in All s ch w i l/Bas el, Switzerland. Actelion's first drug Tracleer®, an orally available dual endothelin receptor antagonist, has been approved as a therapy for pulmonary arterial hypertension. Actelion markets Tracleer® through its own subsidiaries in key markets worldwide, including the United States (based in South San Francisco), the European Union, Japan, 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).
For further information please contact:
Actelion Ltd, Gewerbestrasse 16, CH-4123 Allschwil
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Investor Contact | Roland Haefeli | +41 61 565 62 62 |
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Conference Call
Actelion will host an Investor Conference Call and Webcast on Thursday, 18 October 2007,
15.30 Basel (CEST) / 14.30 U.K. (BST) / 09.30 a.m. U.S. (EDT)
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Dial: | Attention - new numbers: |
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| Europe | +41 44 580 64 03 |
| U.K. | +44 207 108 62 06 |
| U.S. | +1 8 66 89 58 561 |
Webcast – Live and replay on demand
Actelion webcasts it’s 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 10-15 minutes before the conference is due to start. If you experience any access problems go directly to the URL: http://gaia.world-television.com/actelion/20071018/trunc
Approximately 60 minutes after the call has ended, the archived investor webcast will be available for replay through our homepage. After 2 weeks, it will be stored under Investors/Past Events.

