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2015-04-21

Actelion Pharmaceuticals Ltd: 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)

----------------------------------------------------------------------------------
| % variance |
| in CHF millions Q1 2015 Q1 2014 in CHF at CER(1) |
| |
|(except for per share data) |
| US GAAP results |
| Net revenue 515 469 10 12 |
| Operating income 190 153 24 28 |
| Net income 159 128 25 29 |
| Diluted EPS 1.38 1.09 26 30 |
| Core performance |
|(2) |
| Product sales 515 469 10 12 |
| Core earnings 218 189 15 18 |
| Core earnings ex 2014 US rebate reversals 218 172 26 29 |
| Core net income 185 170 9 11 |
| Diluted core EPS 1.61 1.46 10 12 |
| |
| Cash flow |
| Operating cash flow 94 96 |
| Capital expenditure (7) (6) |
| Free cash flow (57) 88 |
| Net cash position 913 731 |
----------------------------------------------------------------------------------

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

--------------------------------------------------------------------------------
| % variance |
| in CHF millions Q1 2015 Q1 2014 in CHF at CER |
| Opsumit 95 15 nm nm |
| Tracleer 344 369 -7% -4% |
| Veletri 19 14 41% 42% |
| Ventavis 31 25 26% 18% |
| Valchlor 5 1 nm nm |
| Zavesca 20 26 -23% -18% |
| Others 2 1 nm nm |
| Total product sales ex US rebate reversals 515 450 14% 16% |
| US rebate reversals - 18 |
| Total product sales 515 469 10% 12% |
--------------------------------------------------------------------------------

Sales by region - year-to-date

--------------------------------------------------------------------------------
| % variance |
| in CHF millions Q1 2015 Q1 2014 in CHF at CER |
| United States 252 173 45% 36% |
| Europe 169 179 -6% 5% |
| Japan 42 49 -16% -8% |
| Rest of the world 53 49 8% 10% |
| Total product sales ex US rebate reversals 515 450 14% 16% |
| US rebate reversals - 18 - - |
| Total product sales 515 469 10% 12% |
--------------------------------------------------------------------------------

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 amounte...

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