Actelion : delivers excellent results in the first quarter 2015

Actelion Pharmaceuticals Ltd / Actelion delivers excellent results in the first quarter 2015 . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 21 April 2015 - Actelion Ltd (SIX: ATLN) today announced its results for the first quarter of 2015. 

OPERATING HIGHLIGHTS

• Opsumit (macitentan) - Q1 2015 sales of CHF 95 million
• Opsumit (macitentan) - approved in Japan in March 2015
• Selexipag (Uptravi) - GRIPHON data presented at American College of Cardiology
• Selexipag (Uptravi) - FDA, EMA regulatory procedures on track
• Specialty franchise - Immunology portfolio advances 

FINANCIAL HIGHLIGHTS

• Product sales of CHF 515 million - strong growth driven by Opsumit uptake
• Core earnings of CHF 218 million - increased operational leverage
• Core EPS of CHF 1.61 - delivering value to shareholders
• Strong performance drives 2015 financial guidance upgrade - now expecting low double-digit percentage core earnings growth at CER (ex 2014 US rebate reversals)

1. CER percentage changes are calculated by reconsolidating both the Q1 2014 and Q1 2015 results at constant currencies (the average monthly exchange rates for Q1 2014).
2. Actelion continues to measure, report and issue guidance on its core operating performance, which management believes more accurately reflects the underlying business performance. The Group believes that these non-GAAP financial measurements provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance.

Jean-Paul Clozel, MD, Chief Executive Officer, commented: "We had an excellent start to 2015 and I am particularly pleased with the continued strong demand for Opsumit. The selexipag data presentation was very well received at the American College of Cardiology congress, and the regulatory procedures are on track. As recently announced, we also made significant progress to build a robust specialty pipeline by advancing our immunology portfolio. Based on the first quarter results I am confident that we are going to surpass our full year targets and we are therefore increasing our guidance."

Otto Schwarz, Chief Operating Officer, commented: "With sales of 95 million Swiss francs during the first quarter of 2015, Opsumit's strong launch momentum continues across all markets, increasing our ERA market share. Moreover, our overall first quarter sales performance across the portfolio has been very satisfying, mainly driven by intrinsic growth, but also enhanced by buying pattern variations. We are also progressing with launch preparations for Opsumit in additional markets such as Japan and Spain."

André C. Muller, Chief Financial Officer, commented: "We are very pleased with the excellent start to the year. The strong intrinsic performance and increased visibility on business dynamics enable us to significantly increase guidance for 2015. We are now confident that, barring unforeseen events, core earnings growth for 2015 will be in the low double-digit percentage range, at constant exchange rates and excluding the benefit of 2014 US rebate reversals."

SALES UPDATE

Actelion's strong first quarter 2015 sales performance was driven by the continued strong Opsumit launch. In the US, sales increased by 36% (ex 2014 rebate reversals) driven by Opsumit, buying pattern variations and price increases across major products. European sales increased by 5% at CER, driven mostly by Opsumit, and Tracleer sales in the digital ulcer indication in a continually negative pricing environment. Sales in Japan decreased by 8% at constant exchange rates mainly due to reduced inventories compared to the first quarter of 2014. Sales in the rest of the world increased by 10% at CER, driven by strong growth in PAH-emerging markets such as China, other Asian and Latin American markets. Comparing average exchange rates for the first quarter of 2015 with the average exchange rates during the first quarter 2014, the Swiss franc appreciated against most major currencies, resulting in a negative currency variance of 9 million Swiss francs or 2%.

Sales by product - year-to-date

 Sales by region - year-to-date

Opsumit^®

Opsumit (macitentan) sales for the first quarter of 2015 amounted to 95 million Swiss francs, reflecting the continued successful launch. The strong patient enrollment trend continued during the first quarter. As per 31 March 2015, Opsumit was successfully launched in the United States, Germany, Austria, the UK, Ireland, Denmark, Sweden, the Netherlands, Australia, Italy, Belgium, Luxembourg, Canada, Finland, Mexico (marketed as Zependo^®), Norway, Iceland, Switzerland, Hungary, Kuwait, Portugal and Israel. On 26 March 2015, Opsumit was approved in Japan. Actelion Pharmaceuticals Japan will locally co-promote Opsumit with Nippon Shinyaku and the companies will ensure that Opsumit is made available to patients as soon as possible.

Tracleer^®

Tracleer (bosentan) sales amounted to 344 million Swiss francs for the first quarter of 2015, a decrease of 4% at CER compared to the first quarter of 2014 or 8% including the impact of prior year US rebate reversals. This decrease is mainly due to erosion in markets where Opsumit is available as well as pricing pressure in Europe, increased generic bosentan competition and a negative inventory effect in Japan. Tracleer sales were supported by replenished inventories returning to normalized levels and price increases in the US, the digital ulcer indication in Europe as well as continued solid demand for Tracleer in markets where Opsumit is not yet available. Underlying units sold globally decreased by 5%.

Veletri^®

Veletri (epoprostenol for injection) sales amounted to 19 million Swiss francs for the first quarter of 2015, an increase of 42% at CER compared to Q1 2014 or 34% including the impact of prior year US rebate reversals. The increase was mostly driven by successful launches in additional markets and continued growth in Japan despite a 5% price cut on 1 March 2014. At the end of March 2015, Veletri was available in the US, UK, Spain, the Netherlands, Australia, New Zealand, Portugal, Poland, Belgium, the Czech Republic and Switzerland, in Japan marketed as Epoprostenol "ACT", and marketed as Caripul^® in both Canada and Italy.

Ventavis^®

During the first quarter of 2015, Ventavis (iloprost) had sales in the US of 31 million Swiss francs, an increase of 18% at CER or 6% including the impact of prior year US rebate reversals. This increase was driven entirely by price, as sales volumes eroded by 12% due to competitive pressures.

Specialty Products

Valchlor^®

Valchlor (mechlorethamine) sales for the first quarter of 2015 amounted to 5 million Swiss francs. The company is making progress in establishing Valchlor as an option in the treatment algorithm of early stage MF-CTCL. The nominative Temporary Authorization for Use (ATU) in France, initiated during the second half of 2014, is progressing well.

Zavesca^®

Zavesca (miglustat) sales amounted to 20 million Swiss francs for the first quarter of 2015, a decrease of 18% at CER compared to the first quarter of 2014 or 17% including the impact of prior year rebate reversals. This decrease is mostly driven by a shift in government purchasing in a number of markets as well as the launch of generic miglustat in Spain (approved for the Type-1 Gaucher disease indication only). Patient demand outside the US in the Niemann-Pick type C indication remains strong, particularly in Japan (where it is marketed as Brazaves^®). Underlying units sold decreased by 13%.

A full financial review is available on www.actelion.com:
http://www.actelion.com/

CLINICAL UPDATE

As announced on 16 April 2015, the company is accelerating its clinical development efforts in the field of immunological disorders, following a broad scientific, medical and commercial evaluation of a series of its selective S1P₁ receptor modulators, discovered in-house.

Actelion has initiated Phase III development with ponesimod, its lead compound, in patients suffering from relapsing multiple sclerosis, with patient enrollment expected imminently.

In parallel, Actelion will also initiate a Phase II study with ponesimod in patients suffering from chronic graft versus host disease. In addition, a second selective S1P₁ receptor modulator will advance into Phase II clinical development in patients with systemic lupus erythematosus.

During the first quarter a new chemical entity entered into man for neurological disorders. Other projects in the clinical development pipeline are progressing according to plan.

RECONCILIATION US GAAP TO CORE RESULTS FOR THE FIRST QUARTER 2015

¹ Rounding differences may occur

NOTE TO SHAREHOLDERS:

The Annual General Meeting (AGM) of Shareholders to approve the Business Report of the year ending
31 December 2014 will be held on 8 May 2015. In order to attend and vote at the Annual General Meeting of Shareholders, shareholders must be registered in the Company's shareholder register by 27 April 2015 at the latest.

UPCOMING EVENTS

• Annual General Meeting 2015 on 08 May 2015
•  HY 2015 Financial Results reporting on 21 July 2015
•  9M 2015 Financial Results reporting on 20 October 2015

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NOTES TO THE EDITOR

ABOUT ACTELION LTD.

Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs.

Actelion is a leader in the field 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 available in all countries, Actelion has treatments approved by health authorities for a number of specialist diseases including Type 1 Gaucher disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.

Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including Europe, the US, Japan, China, Russia and Mexico, Actelion has its corporate headquarters in Allschwil / Basel, Switzerland.

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®). All trademarks are legally protected.

For further information please contact:

Andrew Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com:
http://www.actelion.com/

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;