Actelion announces 9-month financial results 2009
(Thomson Reuters ONE) - Corporate news announcement processed and transmitted by Hugin AS.The issuer is solely responsible for the content of this announcement. ------------------------------------------------------------------------------------ Total net revenues of CHF 1,302.5 million, up 22 percent compared tothe first nine months 2008 - Tracleer® sales of CHF 1,114.7 million,up 19 percent in local currencies - Cash EBIT of CHF 462.0 million,up 33 percent in local currencies - FY 2009 results expected at upperend of guidance range - Positive 2010 growth outlook - Final PhaseIII study results with bosentan and clazosentan in the months aheadALLSCHWIL/BASEL, SWITZERLAND - 20 October 2009 - Actelion Ltd (SIX:ATLN) today announced its financial results for the first nine monthsof 2009. With total net revenues for the first nine months of 2009 ofCHF 1,302.5 million (9M 2008: CHF 1,069.6 m) and operating expensesof CHF 939.3 million (9M 2008: CHF 794.4 m), the company reported anoperating profit of CHF 363.2 million (9M 2008: CHF 275.2 m).To better measure and compare operating performance over time,Actelion continues to report non-US GAAP Cash EBIT (Operating Incomeexcluding charges such as In-Process R&D, charges related to employeestock options under FAS 123R as well as non-cash depreciation andamortization charges). For the first nine months of 2009, Actelionreported a Cash EBIT of CHF 462.0 million, an increase of 30 percentcompared to the same period in 2008. In local currencies, Cash EBITincreased by 33 percent. Adjusted (non-US GAAP) diluted earnings pershare for the first nine months of 2009 were CHF 3.48, compared toCHF 2.53 during the same period last year.On a US GAAP basis, net profit for the first nine months of 2009 wasCHF 326.9 million (9M 2008: CHF 227.4 m). Fully diluted earnings pershare (EPS) on a US GAAP basis for the same period were CHF 2.66,compared to CHF 1.84 for the first nine months of 2008.Jean-Paul Clozel, M.D. and Chief Executive Officer commented:"Actelion continues to execute in-line with its strategy to createlong-term value for patients. Our franchise in pulmonary arterialhypertension will ensure profitable growth going forward. With twoadditional promising PAH compounds in advanced clinical developmentwhich include macitentan and our partnership with Nippon Shinyaku todevelop the PGI2 receptor agonist, we intend to remain on theforefront of PAH research and therapy."Andrew J. Oakley, Chief Financial Officer commented: "In the firstnine months of 2009, Actelion's base business is continuing toperform strongly, despite an adverse currency environment thatespecially impacted Q3 performance as expressed in our reportingcurrency, the Swiss Franc. In July of this year, Actelion upgradedguidance for FY 2009 of both top-line and Cash EBIT growth between 16and 19 percent in local currencies. Today, I can confirm guidance andI forecast that we will very likely be towards the upper end of theranges given."Andrew J. Oakley concluded: "Unforeseen events excluded, Actelion'soutlook for 2010 continues to be positive. I am confident thattop-line growth next year will be in the low-double digit range inlocal currencies, with commercial leverage allowing for both,continued strong cash operating margins and above average investmentin innovative growth opportunities."Financial result overview - Table 9M 2009 vs. 9M 2008In CHF thousands Result 9M 2009 Result 9M Variance % 2008Net Revenues 1,302,541 1,069,620 232,921 22Operating Expenses 939,297 794,424 144,873 18Operating Income 363,244 275,196 88,048 32Cash EBIT 462,008 355,643 106,365 30Net Income* 326,902 227,369 99,533 44Diluted EPS in CHF* 2.66 1.84 0.82 45No of shares in 122,743 123,431calculation* 2006 convertible bond reclassification according to adoption of FSPAPB 14-1 - comparative period adjusted.The full financial statements can be found onhttp://www.actelion.com.Continued growth of total net revenuesDuring the first nine months of 2009, Actelion's total net revenuesincreased by 22 percent to CHF 1,302.5 million (9M 2008: CHF 1,069.6m). In local currencies, total net revenues increased by 23 percentcompared to the first nine months of 2008.Contract revenues for the first nine months of 2009 amounted to CHF47.9 million (9M 2008: CHF 29.2 m).Product salesDuring the first nine months of 2009, Tracleer® (bosentan) sales wereCHF1,114.7 million (9M 2008: CHF 945.8 m). In local currencies, thisrepresents an increase of 19 percent compared to the same period lastyear.In early July, the European Commission approved the pediatricdispersible formulation of Tracleer® for the treatment of pulmonaryarterial hypertension (PAH) in children from two years of age. Thisapproval makes Tracleer® the only PAH therapy with an approvedpediatric formulation.In early August, the U.S. Food and Drug Administration (FDA) approvedthe company's supplemental New Drug Application (sNDA) for Tracleer®to treat patients with mildly symptomatic WHO Functional Class II (FCII) pulmonary arterial hypertension (PAH). The U.S. FDA has alsoapproved Actelion's Risk Evaluation and Mitigation Strategy (REMS)for Tracleer®.At the end of September 2009, Tracleer® was commercially available inover 50 countries worldwide, including all major pharmaceuticalmarkets.Ventavis® (iloprost) sales amounted to CHF 101.6 million for thefirst nine months of 2009(9M 2008: CHF 64.5 m). This represents an increase of 50 percent inUS Dollars. The ongoing strong performance of Ventavis® is mostlikely to trigger a one-off performance milestone payment to BayerSchering Pharma in the near future. Accordingly, Actelion has in thethird quarter accrued this forthcoming USD 10 million payment undercost of goods sold (COGS).In early August 2009, the FDA approved a new 20 microgram permilliliter (mcg/ml) formulation of Ventavis® as a therapy for NewYork Heart Association Class III and IV PAH. This new increased 20mcg/ml strength formulation will deliver the same dose in half thevolume which is expected to reduce inhalation time and furthersupport patient compliance.The approval was based on the submission of technical data showingthat the new formulation did not alter the functional characteristicsof the delivery system or the emitted dose to the patient. A clinicalprogram to evaluate the use of a higher-powered disk for the deliverydevice is ongoing.Otto Schwarz, President Business Operations, commented: "Sales growthremains strong this year driven by Tracleer®, and our outreachefforts to further expand usage in early-stage patients based on thebroadened US product label will sustain Tracleer® growth goingforward. With the US approval of the 20 mcg/ml Ventavis® solution andthe related reduction in inhalation time, we have also strengthenedthe competitive profile of Ventavis®."Efforts are ongoing to further strengthen our PAH franchise with theforthcoming market introduction of an improved, thermostableformulation of epoprostenol sodium for the intravenous treatment ofPAH. This medication was acquired from privately-held GeneraMedixInc. in the first half of 2009.The drug was approved in June 2008 in the United States for thelong-term intravenous treatment of primary pulmonary hypertension andpulmonary hypertension associated with the scleroderma spectrum ofdisease in NYHA Class III and Class IV patients who do not respondadequately to conventional therapy. Outside the United States,Actelion expects to initiate regulatory activities for this product,designed to improve ease of use and patient convenience.In the first nine months of 2009, Zavesca® (miglustat) sales were CHF38.3 million (9M 2008: CHF 30.1 m). In local currencies, Zavesca®sales increased by 33 percent. Zavesca® is commercially available inover 35 countries including the United States and most Europeanmarkets for the treatment of adult patients with mild to moderatetype I Gaucher disease for whom enzyme replacement therapy (ERT) isnot a therapeutic option.Actelion continues its commitment to patients suffering from type 1Gaucher disease, not only by continuing its educational efforts inthe field but also by conducting additional clinical studies.Actelion is following up on the potential use of Zavesca® after aswitch from enzyme replacement therapy by conducting a long-termMAINTENANCE study. This two-year study was fully enrolled with 42patients in June 2008. Study results are expected in H2 2010.In early September 2009, Actelion provided updated information toUS-based Healthcare Professionals who treat type 1 Gaucher patientsregarding the potential use of Zavesca® (miglustat) to minimize theimpact of the supply shortage of imiglucerase (produced and marketedby Genzyme Corporation under the brand name Cerezyme®).In January 2009, Zavesca® received approval in the European Union forthe treatment of progressive neurological manifestations in adultpatients and pediatric patients with Niemann-Pick type C disease(NP-C). Zavesca® is the first treatment to be approved for patientswith Niemann-Pick type C disease, a very rare and devastatingneurodegenerative genetic disorder affecting both children andadults. The market introduction commenced in late Q2 2009 in selectedEuropean markets.In the United States, following a constructive pre-NDA (New DrugApplication) meeting with the FDA in H1 2009, Actelion is currentlyin the process of filing a supplemental NDA for miglustat (Zavesca®)in NP-C.Otto Schwarz concluded: "I am pleased to observe a favorable marketreception for Zavesca® in NPC, resulting in a strongquarter-on-quarter 32 percent growth in local currencies."Operating expensesDuring the first nine months of 2009, operating expenses were CHF939.3 million (9M 2008: CHF 794.4 m).During the same period, research and development expenses increasedby 15 percent to CHF 318.9 million (9M 2008: CHF 277.6 m). Nine-month2008 operating expenses included a milestone payment related to thePGI2 receptor agonist in-licensed from Nippon Shinyaku. Excludingthis payment, R&D expenses increased by 29 percent year on year.Selling, general and administrative expenses for the first ninemonths of 2009 amounted to CHF 449.5 million (9M 2008: CHF 387.6 m),an increase of 16 percent.Research and DevelopmentActelion's pipeline now has 10 compounds in clinical development aswell as more than 25 active projects in drug discovery.Jean-Paul Clozel added: "Since Actelion was founded in late 1997, wehave created a highly productive in-house research and developmentorganization, which results in a broad and promising preclinical andclinical pipeline. To further advance organic value creation, wecontinue to partner with industry leaders such as Glaxo-Smith Kline,Merck and Roche. I am pleased that we are making progress in allthree collaborations, working with fully dedicated partners thatshare our commitment to innovation and changing patient lives."Jean-Paul Clozel continued: "It is exactly the same commitment thatdrives our in-licensing efforts, where we continue to evaluatemultiple promising product opportunities on an ongoing basis tofurther leverage our existing global infrastructure and expertise. Wehave done so successfully in the past with Zavesca® and Ventavis®."There are four compounds in Phase III development, with a fifthexpected to be initiated before year-end 2009. In brief, they are:- Almorexant in primary insomnia: The first Phase III study,part of the RESTORA program, is on schedule to report top-lineresults before the end of 2009. RESTORA 1 is a pivotal study designedto evaluate safety and efficacy of almorexant in patients diagnosedwith primary insomnia. The 700-patient double-blind,placebo-controlled, two-dose, four-arm study includes a reference armwith zolpidem, an approved treatment for insomnia.- Bosentan (Tracleer®) in IPF: This 616 patient,multicenter, double-blind, randomized, placebo-controlled, parallelgroup, event-driven morbidity/mortality study (BUILD-3) is evaluatingthe safety and efficacy of bosentan 125mg b.i.d. in patientsdiagnosed with idiopathic pulmonary fibrosis. Top-line results areexpected in early 2010.- Clazosentan in aSAH: The Phase III study CONSCIOUS-2(Clazosentan to Overcome Neurological iSCHemia and Infarct OccUrringafter Subarachnoid hemorrhage) evaluates efficacy and safety ofClazosentan (5mg/h intravenously for 14 days) versus placebo in 1,146patients post aSAH treated by surgical clipping of the aneurysm. Theprimary endpoint of the study is all-cause mortality andvasospasm-related morbidity, which includes vasospasm-relatedneurological deterioration, vasospasm-related new brain infarcts andinitiation of vasospasm-related rescue therapy. CONSCIOUS-2 resultsare expected to become available by mid-year 2010. If successful,Actelion will approach health authorities for filing. Enrollment isongoing in another Phase III study with clazosentan, CONSCIOUS-3.This 1,500 patient study evaluates the efficacy and safety of twodoses (5 or 15 mg/h) of clazosentan versus placebo in patientspost-aSAH treated by endovascular coiling. The primary endpoint isidentical to that of CONSCIOUS 2.- Macitentan in PAH: The 700 patient multicenter,double-blind, randomized, placebo-controlled, parallel group,event-driven pivotal SERAPHIN program is evaluating safety andefficacy of this highly potent tissue-targeting endothelin receptorantagonist through the primary endpoint of morbidity and all-causemortality in patients with symptomatic PAH. Study results expectedbefore year-end 2012.- Actelion's PGI2 receptor agonist in PAH: Following asuccessful Phase IIa study with this first-in-class orally activenon-prostanoid PGI2 receptor agonist, Actelion is currentlyfinalizing the design for a Phase III program with amorbidity/mortality endpoint. Program initiation is expected beforeyear-end.A comprehensive update on these and all other clinical programs canbe found in the H1 2009 media release, issued on 21 July 2009.In early October 2009, progress was made with Actelion's selectiveS1P1 (Sphingosine-1-phosphate) receptor agonist as the compoundentered into a Phase IIb dose-finding study in patients sufferingfrom multiple sclerosis. This triggered a milestone payment of USD 20million from the S1P1-alliance partner Roche to Actelion.Currently, Actelion and Roche have started to review the data of therecently concluded Phase IIa proof-of-concept study with thisselective S1P1 agonist in psoriasis. Once data analysis hasconcluded, the two companies will make further development decisionsfor this agent targeting multiple autoimmune disorders.Jean-Paul Clozel concluded: "In the months to come, I am lookingforward to reporting clinical data from three Phase III programs:almorexant in primary insomnia, bosentan in idiopathic pulmonaryfibrosis and clazosentan in non-traumatic subarachnoid hemorrhage."Operating profitActelion's operating profit for the first nine months of 2009 was CHF363.2 million (9M 2008: CHF 275.2 m). Cash EBIT for the same periodamounted to CHF 462.0 million (9M 2008: CHF 355.6 m).Net ProfitIn the first nine months of 2009, the net profit of CHF 326.9 million(9M 2008: CHF 227.4 m) includes interest income of CHF 3.6 million,interest expense of CHF 4.8 million, non-cash interest andamortization charges on the Convertible Bond of CHF 13.3 million,foreign currency gains of CHF 15.3 million and an income tax expenseof CHF 37.1 million.Cash and cash flowDuring the first nine months of 2009, Actelion generated net cashflow from operations of CHF 300.9 million (9M 2008: CHF 410.7 m). Asof 30 September 2009, total liquid funds (excluding 8.6 milliontreasury shares) amounted to CHF 1.3 billion.For documentation purposes - table Q3 2009 vs. Q2 2009In CHF thousands Result Result Variance % Q3 2009 Q2 2009Net revenues 447,302 449,626 (2,324) (1)Operating Expenses 326,934 328,381 (1,447) 0- Research and Development 109,318 113,737 (4,419) (4)- Selling, General and Admin. 149,914 160,758 (10,844) (7)Operating Income 120,368 121,245 (877) (1)Cash EBIT 157,161 158,308 (1,147) (1)Net Income 108,462 116,221 (7,759) (7)Diluted EPS in CHF 0.88 0.95 (0.07) (7)No of shares in calculation 123,547 122,033Upcoming Corporate EventsBefore Year-End 2009 - RESTORA-1 in primary insomniaQ1 2010 - BUILD-3 in IPFThursday, 18 February, 2010 - Full Year Results 2009Thursday, 22 April, 2010 - Q1 Results 2010Tuesday, 4 May, 2010 - AGM 2010Mid-2010 - CONSCIOUS-2 in clipped aSAHThursday, 22 July, 2010 - Half Year Results 2010Thursday, 21 October, 2010 - Q3 Results 2010 ###Actelion LtdActelion Ltd is a biopharmaceutical company with its corporateheadquarters in Allschwil/Basel, Switzerland. Actelion's first drugTracleer®, 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 keymarkets worldwide, including the United States (based in South SanFrancisco), the European Union, Japan, Canada, Australia andSwitzerland. Actelion, founded in late 1997, is a leading player ininnovative science related to the endothelium - the single layer ofcells separating every blood vessel from the blood stream. Actelion'sover 2'200 employees focus on the discovery, development andmarketing 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 IndexSMI® )For further information please contact:Roland HaefeliVice President, Head of Investor Relations & Public AffairsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil+41 61 565 62 62+1 650 624 69 36http://www.actelion.comConference CallActelion will host an Investor Conference Call / Webcast as follows:Date/Time:20 October 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)Conference Call Connect #:Dial-in participants should start calling the number below 10-15minutes before the Conference is due to start.Dial: Europe: +41 44 580 64 03 U.K.: +44 203 147 47 53 U.S.: +1 866 931 15 72Participant's mode:Listen-Only with possibility to open individual lines during Q&Asession. Participants will be asked for their Name and Company.Webcast Access:Webcast participants should visit the Actelion website for furtherdetails http://www.actelion.com/10-15 minutes before the conference is due to start. If youexperience any access problems go directly to the URL:http://gaia.world-television.com/actelion/20091020/truncWebcast Replay:The archived Investor Webcast will be available for replay throughhttp://www.actelion.com/ approximately 60 minutes after the call hasended.http://hugin.info/131801/R/1348272/324519.pdfhttp://www.actelion.com/sites/en/external.page?target=http://gaia.world-television.com/actelion/20091020/trunchttp://hugin.info/131801/R/1348272/324483.pdfhttp://hugin.info/131801/R/1348272/324505.pdf --- End of Message ---Actelion Pharmaceuticals LtdGewerbestrasse 16 Allschwil SwitzerlandWKN: 936767; ISIN: CH0010532478; Index: SBIOM, SLIFE, SMCI, SMIEXP, SMIM, SPI, SPIEX;Listed: Main Market in SIX Swiss Exchange;
Datum: 20.10.2009 - 07:00 Uhr
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