ALLSCHWIL/BASEL, SWITZERLAND - 21 July 2009 - Actelion Ltd (SIX: ATLN) today announced its financial results for the first half of 2009. With total net revenues for the first six months of 2009 of CHF 855.2 million (H1 2008: CHF 676.0 m) and operating expenses of CHF 612.4 million (H1 2008: CHF 538.8 m), the company reported an operating profit of CHF 242.9 million (H1 2008: CHF 137.2 m).

 

To better measure and compare operating performance over time, Actelion continues to report non-US GAAP Cash EBIT (Operating Income excluding 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). For the first six months of 2009, Actelion achieved a Cash EBIT of CHF 304.8 million, an increase of 60 percent compared to the same period in 2008. In local currencies, Cash EBIT increased by 61 percent. Adjusted (non-US GAAP) diluted earnings per share for the first six months of 2009 were CHF 2.31, compared to CHF 1.42 during the same period last year.

 

On a US GAAP basis, net profit for the first half of 2009 was CHF 218.4 million (H1 2008: CHF 119.5 m). Starting on 1 January 2009, due to the adoption of FSP APB 14-1, the company incurred total non-cash charges of CHF 8.8 million related to its 2006 convertible bond. The comparative periods have been adjusted.

 

Fully diluted earnings per share (EPS) on a US GAAP basis for the first six months of 2009 were CHF 1.79, compared to CHF 0.97 for the same period in 2008. 

 

 

Jean-Paul Clozel, M.D. and Chief Executive Officer commented: "I am very pleased with our performance in the first six months of 2009. Today, we offer innovative products for patients. We are making significant headway towards obtaining clinical data in the months ahead that might turn development compounds into tomorrow's pharmaceutical options."

 

Jean-Paul Clozel concluded: "I am especially pleased with the promising results of our PGI2 receptor agonist that allows for accelerated development as an oral agent stimulating the prostacyclin pathway. We have also entered a novel anti-infective into clinical development, thereby demonstrating our commitment to bringing our platform approach in research to fruition in multiple areas of high unmet medical demand."

 

Andrew J. Oakley, Chief Financial Officer commented: "Again, Actelion is reporting strong top and bottom line growth. We grow top line revenues as a result of the innovation inherent in our products and the way we appropriately communicate those benefits to treating physicians. We grow our bottom line because we make the appropriate investments at the right time to further advance our rapidly expanding and maturing research and development pipeline."

 

Andrew J. Oakley added: "Considering the operating performance in the first half of 2009, I am confident that Actelion will exceed initial guidance. Hence, Actelion now expects, unforeseen events excluded, that both total net revenues and Cash EBIT - in local currencies - will increase between 16 and 19 percent for the full year of 2009 (initial 2009 revenue guidance: 12 to 15 percent; initial Cash EBIT: 10 to 12 percent).

 

 

In CHF thousands			Result H1 2009			Result H1 2008			Variance			%
Net Revenues			855,239			675,982			179,257			27
Operating Expenses			612,363			538,766			73,597			14
Operating Income			242,876			137,216			105,660			77
Cash EBIT			304,847			190,791			114,056			60
Net Income			218,440			119,479			98,961			83
Diluted EPS in CHF			1.79			0.97			0.82			85
No of shares in calculation			122,340			123,512

 

* 2006 convertible bond reclassification according to adoption of FSP APB 14-1 - comparative period adjusted.

 

The full financial statements can be found on http://www.actelion.com.

 

During the first half of 2009, Actelion's total net revenues increased by 27 percent to CHF 855.2 million (H1 2008: CHF 676.0 m). In local currencies, total net revenues increased by 26 percent compared to the first half of 2008.

 

Contract revenues for the first six months of 2009 amounted to CHF 32.0 million (H1 2008: CHF 13.2 m). As a result of our decision to invest more time in finalizing the design for the remaining almorexant pivotal studies, Actelion has, as of June 2009, changed the recognition of the initial CHF 150 million milestone payment received from Glaxo Smith Kline. The recognition period has been extended by 9 months until the end of 2012. Accordingly, Actelion will now recognize CHF 7.9 million per quarter going forward (previously: CHF 10.0 m in Q1 2009, CHF 9.3 m in Q2 2009).

 

 

Product sales

During the six months of 2009, Tracleer® (bosentan) sales were CHF 739.3 million (H1 2008: CHF 605.2 m). In local currencies, this represents an increase of 23 percent compared to the same period last year.

 

In early July, the European Commission approved the pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children from two years of age. This approval makes Tracleer® the only PAH therapy with an approved pediatric formulation.

 

Following the US Food and Drug Administration complete response letter regarding the Tracleer® supplemental New Drug Application in early March 2009, Actelion has been working closely with the FDA to agree on the details of the Risk Evaluation and Mitigation System (REMS). Once the REMS has been agreed, the FDA will then be in a position to finalize its review of the information submitted for inclusion of less severe (so-called Functional Class II) PAH patients to the US product label.

 

At the end of June 2009, Tracleer® was commercially available in over 50 countries worldwide, including all major pharmaceutical markets.

 

In this reporting period, Tracleer® has also seen approvals for Functional Class II PAH in Canada and Australia. In Croatia, both FC II and the Digital Ulcer indication have also been added to the label. Tracleer® was also approved in New Zealand for use in PAH related to congenital heart disease (Eisenmenger's syndrome). Tracleer also received its first approval in Lebanon for use in FC II and III as well as Digital Ulcers.

 

Ventavis® (iloprost) sales amounted to CHF 61.5 million for the first half of 2009
(H1 2008: CHF 37.9 m). This represents an increase of 50 percent in local currencies.

 

Otto Schwarz, President Business Operations, commented: "In the first six months of 2009, sales growth remained strong. While we continue to record double-digit growth in all major markets worldwide, I am especially pleased with the performance we observed in Japan, where sales growth is a direct response to the sales force increase we undertook between late 2008 and early 2009."

 

Effective 11 March 2009, Actelion acquired an improved, thermostable formulation of epoprostenol sodium for the intravenous treatment of pulmonary arterial hypertension (PAH) from privately-held GeneraMedix Inc. The drug was approved in June 2008 in the United States for the long-term intravenous treatment of primary pulmonary hypertension and pulmonary hypertension associated with the scleroderma spectrum of disease in NYHA Class III and Class IV patients who do not respond adequately to conventional therapy.

 

In the coming months, upon completion of all required administrative and other preparatory tasks, Actelion expects to gradually introduce the improved thermostable formulation of i.v. epoprostenol in the United States. Outside the United States, Actelion expects to initiate regulatory activities for this product that is designed to improve ease of use and patient convenience.

 

In the first six months of 2009, Zavesca® (miglustat) sales were CHF 22.4 million (H1 2008: CHF 19.7 m). In local currencies, Zavesca® sales increased by 19 percent. Zavesca® is commercially available in over 35 countries including the United States and most European markets. In this reporting period, the New Zealand Health Authorities approved Zavesca® for the treatment of adult patients with mild to moderate type I Gaucher disease for whom enzyme replacement therapy (ERT) is not a therapeutic option.

 

Actelion continues its commitment to patients suffering from type 1 Gaucher disease, not only by continuing its educational efforts in the field but also by conducting additional clinical studies. Actelion is following up on the potential use of Zavesca® after a switch from enzyme replacement therapy by conducting a long-term MAINTENANCE study. This two-year study was fully enrolled with 42 patients in June 2008. Study results are expected in H2 2010.

 

In January 2009, Zavesca® received approval in the European Union for the treatment of progressive neurological manifestations in adult patients and pediatric patients with Niemann-Pick type C disease (NP-C). Zavesca® is the first treatment to be approved for patients with Niemann-Pick type C disease, a very rare and devastating neurodegenerative genetic disorder affecting both children and adults. Market introduction commenced in late Q2 2009, with the drug now reimbursed for NP-C in six EU member states.

 

In the United States, following a constructive pre-NDA (New Drug Application) meeting with the FDA, Actelion expects to file a supplemental NDA for miglustat (Zavesca®) in
NP-C in H2 2009.

 

Otto Schwarz concluded: "With Zavesca®, Actelion has the opportunity to achieve significant growth in the years ahead, driven by both increased penetration in the type 1 Gaucher market and by creating a new market for this orally available substrate therapy in NP-C."

 

During the first half of 2009, operating expenses were CHF 612.4 million (H1 2008: CHF 538.8 m).

 

During the same period, research and development expenses increased by 4 percent to CHF 209.6 million (H1 2008: CHF 201.2 m). H1 2008 operating expenses included a milestone payment related to the PGI2 receptor agonist in-licensed from Nippon Shinyaku. Excluding this payment, R&D expenses increased by 23 percent year on year.   

 

Selling, general and administrative expenses for the first six months of 2009 amounted to CHF 299.6 million (H1 2008: CHF 255.1 m), an increase of 17 percent.

 

Actelion's pipeline now has 10 compounds in clinical development as well as more than 25 active projects in drug discovery.

 

Almorexant in primary insomnia: The first Phase III study, which is part of the RESTORA program, is on schedule to conclude in the second half of 2009. RESTORA 1 is a pivotal study designed to evaluate safety and efficacy of almorexant in patients diagnosed with primary insomnia. The 700-patient double-blind, placebo-controlled, two-dose, four-arm study includes a reference arm with zolpidem, an approved treatment for insomnia.

 

As a result of the discussions with the FDA, more time in finalizing the design for the remaining almorexant RESTORA program is required, extending the program timelines by 9 months. The Actelion/GSK collaboration now expects to resubmit the clinical protocols to the FDA to gain a Special Protocol Assessment (SPA) before the end of the year. Accordingly, these pivotal studies are expected to be initiated no sooner than early 2010. In the mean time the non-pivotal program is ongoing.

 

Bosentan (Tracleer®) in IPF: This multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven morbidity/mortality study (BUILD-3) is evaluating the safety and efficacy of bosentan 125mg b.i.d. in patients diagnosed with idiopathic pulmonary fibrosis. BUILD-3 enrollment was completed in October 2008 with 616 patients. The second interim analysis for BUILD-3 (i.e., 75 % of the primary endpoint events) took place on the 7 May 2009, with the independent Data and Safety Monitoring Board (DSMB) recommending continuation of the study.

 

The BUILD-3 study will be closed upon reaching the target 202 confirmed events, which is expected to occur at the end of 2009. Consequently, Actelion expects top-line results to become available in early 2010.

 

Clazosentan in aSAH: The Phase III study CONSCIOUS-2 (Clazosentan to Overcome Neurological iSCHemia and Infarct OccUrring after Subarachnoid hemorrhage) evaluates efficacy and safety of Clazosentan (5mg/h intravenously for 14 days) versus placebo in patients post aSAH treated by surgical clipping of the aneurysm. The primary endpoint of the study is all-cause mortality and vasospasm-related morbidity, which includes vasospasm-related neurological deterioration, vasospasm-related new brain infarcts and initiation of vasospasm-related rescue therapy. CONSCIOUS-2 is currently enrolling at centers in over 25 countries in the EU, Canada, Asia, Australia and New Zealand. At the end of January 2009, Actelion had also initiated additional clinical centers in the United States.

 

Blinded review of the overall event rate indicated a lower than expected event rate. In agreement with the Steering Committee, Actelion has decided - in order to maintain the statistical power of the study and as foreseen in the protocol - to add 381 patients to the initially planned 765 patients. Accordingly, CONSCIOUS-2 results are now expected to become available by mid-year 2010. If successful, Actelion will approach health authorities for filing.

 

A second Phase III study, CONSCIOUS-3, has started enrollment to evaluate the efficacy and safety of two doses (5 or 15 mg/h) of clazosentan versus placebo in patients post-aSAH treated by endovascular coiling. The primary endpoint is identical to that of CONSCIOUS 2, i.e., reduction of the incidence of cerebral vasospasm-related morbidity and all-cause mortality within six weeks. CONSCIOUS-3 will enroll at approximately 150 centers from around 30 countries with a target enrollment of 1500 patients.

 

Macitentan in PAH: The multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven pivotal SERAPHIN program is evaluating safety and efficacy of this highly potent tissue-targeting endothelin receptor antagonist through the primary endpoint of morbidity and all-cause mortality in patients with symptomatic PAH. Global enrollment is ongoing, with over 400 patients already enrolled.

 

As enrollment is significantly faster than previously expected and the event rate slightly lower than initially predicted, Actelion has decided - as foreseen in the protocol - to increase enrollment to 700 patients from the 525 patients originally planned. The company continues to expect study results to become available before the end of 2012, as the target date for full enrollment remains unchanged. SERAPHIN is the largest clinical study in PAH patients and the first to include, from the beginning, a clearly defined morbidity/mortality primary endpoint.

 

Actelion's PGI2 receptor agonist in PAH: Positive data have been obtained in a Phase IIa study with this first-in-class orally active non-prostanoid PGI2 receptor agonist. In the 43-patient placebo-controlled study to assess efficacy, safety and tolerability, the primary endpoint of pulmonary vascular resistance (PVR) change from baseline was met with high statistical significance (p<0.01). The compound was well tolerated.

 

The study results support advancing this first orally active non-prostanoid PGI2 receptor into Phase III. This approach was previously discussed and agreed with the FDA while the study was ongoing. Actelion will now rapidly approach the FDA to finalize the design for a Phase III program with a morbidity/mortality endpoint. Consequently, Actelion expects to initiate this program before year-end.

 

Isaac Kobrin, M.D. and Chief Medical Officer commented: "I am pleased that Actelion has a multitude of innovative agents in various stages of clinical development. We are making significant progress in advancing these compounds, always evaluating on how to best provide physicians with evidence-based medicine. With this in mind, we have carefully adapted the study size for both clazosentan and macitentan to further that goal. In the case of almorexant, we are taking the necessary time to finalize a development approach that satisfies the development requirements of an innovative compound that might enter the GP area."

 

CRTH2 receptor antagonist in asthma: Plans for initiating a Phase II dose-finding study in asthma are progressing on schedule, following the positive proof-of-mechanism data obtained in early 2009 and a pre-IND meeting with the FDA. In the proof-of-mechanism, double-blind placebo-controlled study, the primary endpoint (FEV1) was met and the compound was well tolerated. In addition, preclinical studies showed this compound to inhibit the migration and activation of cell types centrally involved in allergic inflammation.

 

Miglustat in Cystic Fibrosis: The recently concluded Phase IIa proof-of-concept study does not support further clinical development at this time. However, there is a strong scientific rationale described in the published literature (Norez C, Antigny F, Noel S, Vandebrouck C and Becq F. A CF respiratory epithelial cell chronically treated by miglustat acquires a non-CF like phenotype. Am J Respir Cell Mol Biol 2009 Jan 2009 (print forthcoming)). Actelion, therefore, has decided to conduct further preclinical evaluation of miglustat in CF before making final decisions on the future of the compound in this indication.

 

Macitentan in IPF: A pilot clinical development study with this highly potent tissue-targeting endothelin receptor antagonist in idiopathic pulmonary fibrosis has commenced enrollment in H1 2009. The double-blind, randomized, multicenter study will evaluate the efficacy and safety of macitentan in patients with IPF.

 

Selective S1P1 receptor agonist in multiple sclerosis: Following a successful Phase I program, Actelion's first-in-class selective S1P1 receptor agonist partnered with Roche is expected to dose its first patient in a Phase IIb study in the coming months.

 

Selective S1P1 receptor agonist in psoriasis: The proof-of-concept study with 66 patients in psoriasis has completed enrollment in June 2009. Results are expected to become available in the coming months.

 

Novel anti-infective: In mid-July 2009, Actelion initiated Phase I with the first novel anti-infective resulting from its platform approach in research. Anti-Infectives are an important therapeutic area with high unmet medical demand, given the growing resistance observed in daily practice with existing classes of compounds.

 

Martine Clozel, MD and Chief Scientific Officer at Actelion commented: "Actelion has developed platforms of expertise in families of molecular targets which allow high productivity in the generation of innovative compounds potentially addressing a wide range of high unmet medical needs. I am very pleased to be able to announce today that our efforts focused on developing potent, novel classes of antibiotics covering multi-resistant pathogens, with a low propensity for resistance have resulted in our first anti-infective entering clinical studies."

 

Actelion's operating profit for the first half of 2009 was CHF 242.9 million (H1 2008: CHF 137.2 m). Cash EBIT for the same period amounted to CHF 304.8 million (H1 2008: CHF 190.8 m).

 

In the first half of 2009, the net profit of CHF 218.4 million (H1 2008: CHF 119.5 m) includes interest income of CHF 2.5 million, interest expense of CHF 2.5 million, non-cash interest and amortization charges on the Convertible Bond of CHF 8.8 million, foreign currency gains of CHF 7.5 million and an income tax expense of CHF 23.1 million. 

 

During the first half of 2009, Actelion generated net cash flow from operations of CHF 127.2 million (H1 2008: CHF 141.4 m). As of 30 June 2009, total liquid funds (excluding 7.8 million treasury shares) amounted to CHF 1.2 billion.

 

  

 

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Actelion Ltd is a biopharmaceutical company with its corporate headquarters in Allschwil/Basel, 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's over 2000 employees focus on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as part of the Swiss blue-chip index SMI (Swiss Market Index SMI® )

 

Roland Haefeli

Vice President, Head of Investor Relations & Public Affairs

Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil

+41 61 565 62 62

+1 650 624 69 36

 

Actelion will host an Investor Conference Call / Webcast as follows:

 

 

21 July 2009		15.30 hrs - 16.30 hrs		Basel (CEST)
		14.30 hrs - 15.30 hrs		U.K. (BST)
		09.30 a.m. - 10.30 a.m.		U.S. (EDT)

                              

Dial-in participants should start calling the number below 10-15 minutes before the Conference is due to start.

 

Listen-Only with possibility to open individual lines during Q&A session. Participants will be asked for their Name and Company.

 

Webcast participants should visit the Actelion website for further details 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/20090721/trunc

 

The archived Investor Webcast will be available for replay through http://www.actelion.com/ approximately 60 minutes after the call has ended.