Actelion announces Half Year financial results 2009>
Actelion announces Half Year 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 855.2 million, up 27 percent compared to H12008 - Tracleer® sales of CHF 739.3 million, up 23 percent in localcurrencies - Cash EBIT of CHF 304.8 million - Upgraded top and bottomline guidance - Key Phase III results reporting starting in Q4 2009with almorexant in RESTORA-1 - BUILD-3 with bosentan in IPF in early2010 - clazosentan in aSAH by-mid 2010ALLSCHWIL/BASEL, SWITZERLAND - 21 July 2009 - Actelion Ltd (SIX:ATLN) today announced its financial results for the first half of2009. With total net revenues for the first six months of 2009 of CHF855.2 million (H1 2008: CHF 676.0 m) and operating expenses of CHF612.4 million (H1 2008: CHF 538.8 m), the company reported anoperating 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 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 six months of 2009, Actelionachieved a Cash EBIT of CHF 304.8 million, an increase of 60 percentcompared to the same period in 2008. In local currencies, Cash EBITincreased by 61 percent. Adjusted (non-US GAAP) diluted earnings pershare for the first six months of 2009 were CHF 2.31, compared to CHF1.42 during the same period last year.On a US GAAP basis, net profit for the first half of 2009 was CHF218.4 million (H1 2008: CHF 119.5 m). Starting on 1 January 2009, dueto the adoption of FSP APB 14-1, the company incurred total non-cashcharges of CHF 8.8 million related to its 2006 convertible bond. Thecomparative periods have been adjusted.Fully diluted earnings per share (EPS) on a US GAAP basis for thefirst six months of 2009 were CHF 1.79, compared to CHF 0.97 for thesame period in 2008.Jean-Paul Clozel, M.D. and Chief Executive Officer commented: "I amvery pleased with our performance in the first six months of 2009.Today, we offer innovative products for patients. We are makingsignificant headway towards obtaining clinical data in the monthsahead that might turn development compounds into tomorrow'spharmaceutical options."Jean-Paul Clozel concluded: "I am especially pleased with thepromising results of our PGI2 receptor agonist that allows foraccelerated development as an oral agent stimulating the prostacyclinpathway. We have also entered a novel anti-infective into clinicaldevelopment, thereby demonstrating our commitment to bringing ourplatform approach in research to fruition in multiple areas of highunmet medical demand."Andrew J. Oakley, Chief Financial Officer commented: "Again, Actelionis reporting strong top and bottom line growth. We grow top linerevenues as a result of the innovation inherent in our products andthe way we appropriately communicate those benefits to treatingphysicians. We grow our bottom line because we make the appropriateinvestments at the right time to further advance our rapidlyexpanding and maturing research and development pipeline."Andrew J. Oakley added: "Considering the operating performance in thefirst half of 2009, I am confident that Actelion will exceed initialguidance. 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).Financial result overview - Table H1 2009 vs. H1 2008In CHF thousands Result H1 Result H1 Variance % 2009 2008Net Revenues 855,239 675,982 179,257 27Operating Expenses 612,363 538,766 73,597 14Operating Income 242,876 137,216 105,660 77Cash EBIT 304,847 190,791 114,056 60Net Income 218,440 119,479 98,961 83Diluted EPS in CHF 1.79 0.97 0.82 85No of shares in 122,340 123,512calculation* 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 half of 2009, Actelion's total net revenuesincreased by 27 percent to CHF 855.2 million (H1 2008: CHF 676.0 m).In local currencies, total net revenues increased by 26 percentcompared to the first half of 2008.Contract revenues for the first six months of 2009 amounted to CHF32.0 million (H1 2008: CHF 13.2 m). As a result of our decision toinvest more time in finalizing the design for the remainingalmorexant pivotal studies, Actelion has, as of June 2009, changedthe recognition of the initial CHF 150 million milestone paymentreceived from Glaxo Smith Kline. The recognition period has beenextended by 9 months until the end of 2012. Accordingly, Actelionwill 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 salesDuring the six months of 2009, Tracleer® (bosentan) sales were CHF739.3 million (H1 2008: CHF 605.2 m). In local currencies, thisrepresents an increase of 23 percent compared to the same period lastyear.In early July, the European Commission approved the pediatricdispersible formulation of Tracleer® (bosentan) for the treatment ofpulmonary arterial hypertension (PAH) in children from two years ofage. This approval makes Tracleer® the only PAH therapy with anapproved pediatric formulation.Following the US Food and Drug Administration complete responseletter regarding the Tracleer® supplemental New Drug Application inearly March 2009, Actelion has been working closely with the FDA toagree on the details of the Risk Evaluation and Mitigation System(REMS). Once the REMS has been agreed, the FDA will then be in aposition to finalize its review of the information submitted forinclusion of less severe (so-called Functional Class II) PAH patientsto the US product label.At the end of June 2009, Tracleer® was commercially available in over50 countries worldwide, including all major pharmaceutical markets.In this reporting period, Tracleer® has also seen approvals forFunctional Class II PAH in Canada and Australia. In Croatia, both FCII and the Digital Ulcer indication have also been added to thelabel. Tracleer® was also approved in New Zealand for use in PAHrelated to congenital heart disease (Eisenmenger's syndrome).Tracleer also received its first approval in Lebanon for use in FC IIand III as well as Digital Ulcers.Ventavis® (iloprost) sales amounted to CHF 61.5 million for the firsthalf of 2009(H1 2008: CHF 37.9 m). This represents an increase of 50 percent inlocal currencies.Otto Schwarz, President Business Operations, commented: "In the firstsix months of 2009, sales growth remained strong. While we continueto record double-digit growth in all major markets worldwide, I amespecially pleased with the performance we observed in Japan, wheresales growth is a direct response to the sales force increase weundertook between late 2008 and early 2009."Effective 11 March 2009, Actelion acquired an improved, thermostableformulation of epoprostenol sodium for the intravenous treatment ofpulmonary arterial hypertension (PAH) from privately-held GeneraMedixInc. 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.In the coming months, upon completion of all required administrativeand other preparatory tasks, Actelion expects to gradually introducethe improved thermostable formulation of i.v. epoprostenol in theUnited States. Outside the United States, Actelion expects toinitiate regulatory activities for this product that is designed toimprove ease of use and patient convenience.In the first six months of 2009, Zavesca® (miglustat) sales were CHF22.4 million (H1 2008: CHF 19.7 m). In local currencies, Zavesca®sales increased by 19 percent. Zavesca® is commercially available inover 35 countries including the United States and most Europeanmarkets. In this reporting period, the New Zealand Health Authoritiesapproved Zavesca® for the treatment of adult patients with mild tomoderate type I Gaucher disease for whom enzyme replacement therapy(ERT) is not 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 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. Market introduction commenced in late Q2 2009, with the drugnow reimbursed for NP-C in six EU member states.In the United States, following a constructive pre-NDA (New DrugApplication) meeting with the FDA, Actelion expects to file asupplemental NDA for miglustat (Zavesca®) inNP-C in H2 2009.Otto Schwarz concluded: "With Zavesca®, Actelion has the opportunityto achieve significant growth in the years ahead, driven by bothincreased penetration in the type 1 Gaucher market and by creating anew market for this orally available substrate therapy in NP-C."Operating expensesDuring the first half of 2009, operating expenses were CHF 612.4million (H1 2008: CHF 538.8 m).During the same period, research and development expenses increasedby 4 percent to CHF 209.6 million (H1 2008: CHF 201.2 m). H1 2008operating expenses included a milestone payment related to the PGI2receptor agonist in-licensed from Nippon Shinyaku. Excluding thispayment, R&D expenses increased by 23 percent year on year.Selling, general and administrative expenses for the first six monthsof 2009 amounted to CHF 299.6 million (H1 2008: CHF 255.1 m), anincrease of 17 percent.Research and DevelopmentActelion's pipeline now has 10 compounds in clinical development aswell as more than 25 active projects in drug discovery.Almorexant in primary insomnia: The first Phase III study, which ispart of the RESTORA program, is on schedule to conclude in the secondhalf of 2009. RESTORA 1 is a pivotal study designed to evaluatesafety and efficacy of almorexant in patients diagnosed with primaryinsomnia. The 700-patient double-blind, placebo-controlled, two-dose,four-arm study includes a reference arm with zolpidem, an approvedtreatment for insomnia.As a result of the discussions with the FDA, more time in finalizingthe design for the remaining almorexant RESTORA program is required,extending the program timelines by 9 months. The Actelion/GSKcollaboration now expects to resubmit the clinical protocols to theFDA to gain a Special Protocol Assessment (SPA) before the end of theyear. Accordingly, these pivotal studies are expected to be initiatedno sooner than early 2010. In the mean time the non-pivotal programis ongoing.Bosentan (Tracleer®) in IPF: This multicenter, double-blind,randomized, placebo-controlled, parallel group, event-drivenmorbidity/mortality study (BUILD-3) is evaluating the safety andefficacy of bosentan 125mg b.i.d. in patients diagnosed withidiopathic pulmonary fibrosis. BUILD-3 enrollment was completed inOctober 2008 with 616 patients. The second interim analysis forBUILD-3 (i.e., 75 % of the primary endpoint events) took place on the7 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 202confirmed events, which is expected to occur at the end of 2009.Consequently, Actelion expects top-line results to become availablein early 2010.Clazosentan in aSAH: The Phase III study CONSCIOUS-2 (Clazosentan toOvercome Neurological iSCHemia and Infarct OccUrring afterSubarachnoid hemorrhage) evaluates efficacy and safety of Clazosentan(5mg/h intravenously for 14 days) versus placebo in patients postaSAH treated by surgical clipping of the aneurysm. The primaryendpoint of the study is all-cause mortality and vasospasm-relatedmorbidity, which includes vasospasm-related neurologicaldeterioration, vasospasm-related new brain infarcts and initiation ofvasospasm-related rescue therapy. CONSCIOUS-2 is currently enrollingat centers in over 25 countries in the EU, Canada, Asia, Australiaand New Zealand. At the end of January 2009, Actelion had alsoinitiated additional clinical centers in the United States.Blinded review of the overall event rate indicated a lower thanexpected event rate. In agreement with the Steering Committee,Actelion has decided - in order to maintain the statistical power ofthe study and as foreseen in the protocol - to add 381 patients tothe initially planned 765 patients. Accordingly, CONSCIOUS-2 resultsare 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 toevaluate the efficacy and safety of two doses (5 or 15 mg/h) ofclazosentan versus placebo in patients post-aSAH treated byendovascular coiling. The primary endpoint is identical to that ofCONSCIOUS 2, i.e., reduction of the incidence of cerebralvasospasm-related morbidity and all-cause mortality within six weeks.CONSCIOUS-3 will enroll at approximately 150 centers from around 30countries with a target enrollment of 1500 patients.Macitentan in PAH: The multicenter, double-blind, randomized,placebo-controlled, parallel group, event-driven pivotal SERAPHINprogram is evaluating safety and efficacy of this highly potenttissue-targeting endothelin receptor antagonist through the primaryendpoint of morbidity and all-cause mortality in patients withsymptomatic PAH. Global enrollment is ongoing, with over 400 patientsalready enrolled.As enrollment is significantly faster than previously expected andthe event rate slightly lower than initially predicted, Actelion hasdecided - as foreseen in the protocol - to increase enrollment to 700patients from the 525 patients originally planned. The companycontinues to expect study results to become available before the endof 2012, as the target date for full enrollment remains unchanged.SERAPHIN is the largest clinical study in PAH patients and the firstto include, from the beginning, a clearly defined morbidity/mortalityprimary endpoint.Actelion's PGI2 receptor agonist in PAH: Positive data have beenobtained in a Phase IIa study with this first-in-class orally activenon-prostanoid PGI2 receptor agonist. In the 43-patientplacebo-controlled study to assess efficacy, safety and tolerability,the primary endpoint of pulmonary vascular resistance (PVR) changefrom baseline was met with high statistical significance (p<0.01).The compound was well tolerated.The study results support advancing this first orally activenon-prostanoid PGI2 receptor into Phase III. This approach waspreviously discussed and agreed with the FDA while the study wasongoing. Actelion will now rapidly approach the FDA to finalize thedesign for a Phase III program with a morbidity/mortality endpoint.Consequently, Actelion expects to initiate this program beforeyear-end.Isaac Kobrin, M.D. and Chief Medical Officer commented: "I am pleasedthat Actelion has a multitude of innovative agents in various stagesof clinical development. We are making significant progress inadvancing these compounds, always evaluating on how to best providephysicians with evidence-based medicine. With this in mind, we havecarefully adapted the study size for both clazosentan and macitentanto further that goal. In the case of almorexant, we are taking thenecessary time to finalize a development approach that satisfies thedevelopment requirements of an innovative compound that might enterthe GP area."CRTH2 receptor antagonist in asthma: Plans for initiating a Phase IIdose-finding study in asthma are progressing on schedule, followingthe positive proof-of-mechanism data obtained in early 2009 and apre-IND meeting with the FDA. In the proof-of-mechanism, double-blindplacebo-controlled study, the primary endpoint (FEV1) was met and thecompound was well tolerated. In addition, preclinical studies showedthis compound to inhibit the migration and activation of cell typescentrally involved in allergic inflammation.Miglustat in Cystic Fibrosis: The recently concluded Phase IIaproof-of-concept study does not support further clinical developmentat this time. However, there is a strong scientific rationaledescribed in the published literature (Norez C, Antigny F, Noel S,Vandebrouck C and Becq F. A CF respiratory epithelial cellchronically treated by miglustat acquires a non-CF like phenotype. AmJ Respir Cell Mol Biol 2009 Jan 2009 (print forthcoming)). Actelion,therefore, has decided to conduct further preclinical evaluation ofmiglustat in CF before making final decisions on the future of thecompound in this indication.Macitentan in IPF: A pilot clinical development study with thishighly potent tissue-targeting endothelin receptor antagonist inidiopathic pulmonary fibrosis has commenced enrollment in H1 2009.The double-blind, randomized, multicenter study will evaluate theefficacy and safety of macitentan in patients with IPF.Selective S1P1 receptor agonist in multiple sclerosis: Following asuccessful Phase I program, Actelion's first-in-class selective S1P1receptor agonist partnered with Roche is expected to dose its firstpatient in a Phase IIb study in the coming months.Selective S1P1 receptor agonist in psoriasis: The proof-of-conceptstudy with 66 patients in psoriasis has completed enrollment in June2009. Results are expected to become available in the coming months.Novel anti-infective: In mid-July 2009, Actelion initiated Phase Iwith the first novel anti-infective resulting from its platformapproach in research. Anti-Infectives are an important therapeuticarea with high unmet medical demand, given the growing resistanceobserved in daily practice with existing classes of compounds.Martine Clozel, MD and Chief Scientific Officer at Actelioncommented: "Actelion has developed platforms of expertise in familiesof molecular targets which allow high productivity in the generationof innovative compounds potentially addressing a wide range of highunmet medical needs. I am very pleased to be able to announce todaythat our efforts focused on developing potent, novel classes ofantibiotics covering multi-resistant pathogens, with a low propensityfor resistance have resulted in our first anti-infective enteringclinical studies."Operating profitActelion's operating profit for the first half of 2009 was CHF 242.9million (H1 2008: CHF 137.2 m). Cash EBIT for the same periodamounted to CHF 304.8 million (H1 2008: CHF 190.8 m).Net ProfitIn the first half of 2009, the net profit of CHF 218.4 million (H12008: CHF 119.5 m) includes interest income of CHF 2.5 million,interest expense of CHF 2.5 million, non-cash interest andamortization charges on the Convertible Bond of CHF 8.8 million,foreign currency gains of CHF 7.5 million and an income tax expenseof CHF 23.1 million.Cash and cash flowDuring the first half of 2009, Actelion generated net cash flow fromoperations of CHF 127.2 million (H1 2008: CHF 141.4 m). As of 30 June2009, total liquid funds (excluding 7.8 million treasury shares)amounted to CHF 1.2 billion.For documentation purposes - table Q2 2009 vs. Q1 2009In CHF thousands Result Result Variance % Q2 2009 Q1 2009Net revenues 449,626 405,613 44,013 11Operating Expenses 328,381 283,982 44,399 16- Research and 113,737 95,848 17,889 19Development- Selling, General and 160,758 138,831 21,927 16Admin.Operating Income 121,245 121,631 (386) 0Cash EBIT 158,308 146,539 11,769 8Net Income 116,221 102,143 14,078 14Diluted EPS in CHF 0.95 0.83 0.12 14No of shares in 122,033 122,647calculation ###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 2000 employees focus on the discovery, development and marketingof innovative drugs for significant unmet medical needs. Actelionshares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) aspart of the Swiss blue-chip index SMI (Swiss Market Index SMI® )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: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)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 52 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/20090721/truncWebcast Replay:The archived Investor Webcast will be available for replay throughhttp://www.actelion.com/ approximately 60 minutes after the call hasended.Upcoming Corporate EventsTuesday, 20 October, 2009 - Q3 Results 2009Thursday, 18 February, 2010 - Full Year Results 2009Thursday, 22 April, 2010 - Q1 Results 2010Tuesday, 4 May, 2010 - AGM 2010Thursday, 22 July, 2010 - Half Year Results 2010Thursday, 21 October, 2010 - Q3 Results 2010http://hugin.info/131801/R/1329884/314122.pdfhttp://www.actelion.com/en/investors/events/quarterly-reporting.page?http://hugin.info/131801/R/1329884/314125.pdfhttp://hugin.info/131801/R/1329884/314126.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;
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