ALLSCHWIL/BASEL, SWITZERLAND – 09 February 2016 – Actelion Ltd (ATLN.VX) today appear its after-effects for the abounding year 2015.
Jean-Paul Clozel, MD, Chief Executive Officer, commented: “2015 was an outstanding year for Actelion, with almanac sales and earnings. Added chiefly for me, these outstanding banking after-effects accept been accompanied by cogent transformation of the company. With the absorbing abandonment of Opsumit and with Uptravi now on the market, we accept a abundant belvedere to body and advance in our future. We accept adapted our PAH portfolio and the about-face of our activity is able-bodied underway. As a result, we now accept the befalling to become the aboriginal European-born biopharma to accomplish it to the aloft league.”
Otto Schwarz, Chief Operating Officer, commented: “The accomplished barrage drive of Opsumit, beyond all markets, has resulted in added than 13,600 patients on analysis at the end of 2015. Following the US approval of Uptravi and consecutive barrage in January of this year, we are now alive agilely to ensure added patients can account from this atypical analysis targeting the prostacyclin pathway. With Opsumit, Uptravi and Veletri, we are abnormally positioned to body and serve the PAH community, accoutrement the continuum of affliction with outcome-based medicines.”
André C. Muller, Chief Banking Officer, commented: “Actelion has delivered an accomplished achievement in 2015. Our bartering operations accept delivered sales of added than 2 billion Swiss francs, admitting the abrupt acknowledgment of the Swiss franc in January 2015. This able achievement forth with bound banking conduct accustomed the balance ability of our business with amount balance growing added than alert as fast as sales.”
Barring abrupt events, Actelion forecasts 2016 amount operating income, at connected barter rates, to abound in the low single-digit allotment range. This apprehension involves a cardinal of assumptions including Opsumit and Uptravi barrage dynamics, all-encompassing pressures mainly in the US and appraisement burden in Europe and Japan.
PRODUCT SALESActelion`s accomplished bartering achievement during 2015 was mainly due to the connected able uptake of Opsumit, apprenticed by consistently able application of new patients beyond markets and amplification of the endothelin receptor adversary (ERA) bazaar due to added aggregate analysis with PDE-5 inhibitors. In the US, sales added by 21% at CER, excluding 2014 abatement reversals, and were apprenticed by Opsumit uptake, ERA bazaar allotment assets and ERA bazaar expansion, as able-bodied as amount increases beyond the portfolio. European sales added by 3% at CER admitting connected appraisement burden and bazaar abrasion from generics, with advance apprenticed mostly by new Opsumit markets and use of Tracleer in the calendar abscess indication. Sales in Japan added by 11% at CER in a aggressive environment. Advance was apprenticed by sales of Opsumit (launched in backward June 2015), Tracleer in the calendar abscess adumbration (launched in September 2015), Veletri and Zavesca (Japanese barter name Brazaves®).
Comparing boilerplate barter ante for 2015 with 2014, the Swiss franc accustomed adjoin best aloft currencies except the US dollar, consistent in a abrogating bill about-face of 55 actor Swiss francs.
Opsumit®Sales of Opsumit (macitentan) amounted to 516 actor Swiss francs, absorption a abiding awful acknowledged launch. Opsumit is now accessible to patients in over 35 countries and accepting ERA bazaar allotment in all geographies. Able accommodating appeal continued, with added than 13,600 patients on analysis at the end of December 2015 (almost 50% from the US). Accommodating advance was apprenticed by an accretion bazaar allotment in the ERA-naive accommodating articulation and added aggregate with PDE-5 inhibitors, as able-bodied as new bazaar launches (e.g. Japan, Israel).
Tracleer®Sales of Tracleer (bosentan) amounted to 1,212 actor Swiss francs, a abatement of 11% at CER excluding 2014 US abatement reversals. This abatement is mostly attributed to lower volumes in countries area Opsumit is available, due to acutely decreased acceptance of new patients. Sales were added impacted by connected appraisement burden in Europe and added all-encompassing bosentan competition. Basal units awash globally decreased by 6%.
Following the Pediatric Analysis Plan (PIP) acquiescence account from the European Committee for Medicinal Articles for Human Use (CHMP), applications for addendum of the Supplementary Aegis Certificate (SPC) were filed in 19 EU countries. Extensions of apparent aegis for Tracleer accept now been accustomed in Belgium, Denmark, Finland, France, Italy, Ireland, Luxembourg, the Netherlands, Spain and Sweden.
Tracleer sales were absolutely accurate by the calendar abscess (DU) adumbration in Europe and Japan (launched in September 2015), a amount access in the US and connected solid appeal in markets area Opsumit is not yet available. Overall, added than 46,000 patients were accepting the biologic globally at the end of 2015 (a abatement of 9% adjoin above-mentioned year).
Veletri®Sales of Veletri (epoprostenol for injection) amounted to 83 actor Swiss francs, an access of 37% at CER, excluding 2014 US abatement reversals, with over 1,900 patients accepting the biologic at the end of 2015. The access was mostly apprenticed by added bazaar penetration, acknowledged launches in added markets – conspicuously in France, Europe`s better i.v. epoprostenol bazaar – and connected advance in Japan. At the end of December 2015, Veletri was accessible in 15 countries worldwide.
Ventavis®Sales of Ventavis (iloprost) amounted to 105 actor Swiss francs, a abatement of 7% at CER, excluding the appulse of above-mentioned year US abatement reversals. The basal 20% assemblage abatement due to connected aggressive burden was mitigated by amount increases.
Valchlor®Sales of Valchlor (mechlorethamine) amounted to 27 actor Swiss francs. In the US, the aggregation is continuing its efforts to authorize Valchlor as a first-line advantage in the analysis algorithm for early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).
In France, patients benefited from the biologic beneath a acting allotment for use (“ATU”) affairs accomplished during the additional bisected of 2014. The abstracts for Valchlor (under the barter name Ledaga®) was accustomed by the European Medicines Agency during the additional division of 2015 and is currently beneath review.
Zavesca®Sales of Zavesca (miglustat) amounted to 92 actor Swiss francs, a abatement of 3% at CER, excluding the appulse of above-mentioned year US abatement reversals. Basal assemblage sales were collapsed compared to the above-mentioned year.
Sales in the US beneath mainly as a aftereffect of aggressive burden from another agitator backup analysis (ERT) options for the blazon 1 Gaucher ache (GD1) indication. In Europe, a abatement in the GD1 business due to all-encompassing antagonism in called markets was mitigated by added accommodating appeal in the Niemann-Pick blazon C indication, apprenticed by Japan (where it is marketed as Brazaves®), Italy, France and Russia. At the end of 2015, all-encompassing miglustat (approved for GD1 only) was commercially accessible in Spain, Sweden, Germany and the Czech Republic.
CORE R&D EXPENDITURECore R&D costs amounted to 404 actor Swiss francs, an access of 10% at CER. This access was apprenticed by college analytic balloon expenses, as the aggregation is advancing its specialty immunology portfolio, macitentan life-cycle extensions and added late-stage activity assets, as able-bodied as connected advance in the earlier-stage pipeline. Amount R&D amount represented 20% of artefact sales, hardly college than in 2014. Actelion will abide to focus on anxiously acclimation investments so as to ensure approaching advance and charge of adapted actor returns.
CORE EARNINGSCore operating assets amounted to 814 actor Swiss francs, an access of 14% at CER. Excluding the appulse of prior-year US abatement reversals, amount operating assets added by 25% at CER. The backbone of the Swiss franc adjoin best currencies except the US dollar had a abrogating appulse of 32 actor Swiss francs on amount operating income.
CORE EPSDiluted amount balance per allotment were CHF 6.16 for the abounding year 2015, an access of 15% at CER compared to the aforementioned aeon of 2014.
DELIVERING VALUE TO SHAREHOLDERSActelion has connected to accomplish cogent advance in carrying on its action for amount creation. The year`s highlights accommodate the connected absolute auspiciously Opsumit barrage as able-bodied as the FDA approval of Uptravi. A able bartering performance, accumulated with bound banking oversight, was reflected in Actelion`s allotment price: with an access of 21%, the aggregation was one of the top performers on the Swiss Bazaar Basis (SMI). Including the dividend, absolute actor acknowledgment amounted to 22%. Bazaar assets at the end of 2015 was 15.9 billion Swiss francs.
In 2012, Actelion fabricated a charge to acknowledgment cogent basic to shareholders. The aggregation has delivered on that promise, with over 2 billion Swiss francs actuality alternate to shareholders in the anatomy of assets and allotment repurchase programs over the accomplished four years. The Board of Directors will additionally adduce an added anniversary allotment acquittal of CHF 1.50 for approval by shareholders at the accessible Anniversary Accepted Affair in May.
PIPELINE UPDATEActelion`s able R&D activity comprises atypical compounds acclamation a ample ambit of diseases, including cardiovascular and immunological disorders as able-bodied as axial afraid arrangement disorders and communicable diseases.
Actelion`s late-stage artefact candidates accommodate the atypical antibacterial cadazolid, beneath analysis for Clostridium difficile-associated diarrhea (CDAD) and a S1P1 receptor modulator, ponesimod, advised in assorted sclerosis.
HUMAN RESOURCESAt the end of 2015, Actelion active 2,547 abiding advisers worldwide, an access of 3% (or 77 abiding positions) compared to the end of 2014.
ANNUAL REPORTFull capacity on the advance fabricated in 2015 are accessible in Actelion`s 2015 Anniversary Report, at www.actelion.com/annual-report.
NOTES TO SHAREHOLDERS:The Anniversary Accepted Affair (AGM) of Shareholders to accept the Business Report of the year catastrophe 31 December 2015 will be captivated on 4 May 2016.
At the AGM, the Board of Directors will acclaim that shareholders accept a allotment of CHF 1.50 per share, an access of 15%.
Shareholders captivation added than CHF 1,000,000 nominal amount of shares (i.e. 2,000,000 shares at nominal amount of CHF 0.50), actuality advantaged to add items to the calendar of the accepted affair of shareholders, are access to accelerate in proposals, if any, to Actelion Ltd, absorption Accumulated Secretary, Gewerbestrasse 16, CH-4123 Allschwil, to access no afterwards than 18 March 2016. Any angle accustomed afterwards the borderline will be disregarded.
In adjustment to appear and vote at the Anniversary Accepted Affair of Shareholders, shareholders charge be registered in the company`s actor annals by 22 April 2016 at the latest.
RESULTS DAY CENTERInvestor community: To accomplish your job easier, we accommodate links to all accordant affidavit from the After-effects Day Center on our accumulated website: www.actelion.com/results-day-center
NOTES TO THE EDITOR
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ABOUT ACTELION LTD.Actelion Ltd. is a arch biopharmaceutical aggregation focused on the discovery, development and commercialization of avant-garde drugs for diseases with cogent unmet medical needs.
Actelion is a baton in the acreage of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Although not accessible in all countries, Actelion additionally has treatments accustomed by bloom authorities for a cardinal of specialist diseases including Blazon 1 Gaucher disease, Niemann-Pick blazon C disease, Calendar Ulcers in patients adversity from systemic sclerosis, and mycosis fungoides blazon cutaneous T-cell lymphoma.
Founded in backward 1997, with now over 2,500 committed professionals accoutrement all key markets about the apple including Europe, the US, Japan, China, Russia and Mexico, Actelion has its accumulated address in Allschwil / Basel, Switzerland.
Actelion shares are traded on the SIX Swiss Barter (ticker sym: ATLN) as allotment of the Swiss baddest basis SMI (Swiss Bazaar Basis SMI®). All trademarks are accurately protected.
For added advice amuse contact:Andrew C. WeissSenior Vice President, Head of Investor Relations & Accumulated CommunicationsActelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil 41 61 565 62 62www.actelion.com
The aloft advice contains assertive “forward-looking statements”, apropos to the company`s business, which can be articular by the use of advanced analogue such as “estimates”, “believes”, “expects”, “may”, “are accepted to”, “will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or agnate expressions, or by discussions of strategy, affairs or intentions. Such statements accommodate descriptions of the company`s advance and analysis and development programs and advancing expenditures in affiliation therewith, descriptions of new articles accepted to be alien by the aggregation and advancing chump appeal for such articles and articles in the company`s absolute portfolio. Such statements reflect the accepted angle of the aggregation with account to approaching contest and are accountable to assertive risks, uncertainties and assumptions. Many factors could account the absolute results, achievement or achievements of the aggregation to be materially altered from any approaching results, performances or achievements that may be bidding or adumbrated by such advanced statements. Should one or added of these risks or uncertainties materialize, or should basal assumptions prove incorrect, absolute after-effects may alter materially from those declared herein as anticipated, believed, estimated or expected.
Financial actuality sheetFinancial statementsActelion After-effects Day CenterWebcastActelion Anniversary ReportPress absolution PDF
This advertisement is broadcast by NASDAQ OMX Accumulated Solutions on account of NASDAQ OMX Accumulated Solutions clients.
The issuer of this advertisement warrants that they are alone amenable for the content, accurateness and dness of the advice independent therein.Source: Actelion Pharmaceuticals Ltd via GlobeNewswireHUG#1984563
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