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2016-07-21

Actelion Pharmaceuticals Ltd: Very strong performance in the first half of 2016 ­- enhanced by successful Uptravi US launch

Actelion Pharmaceuticals Ltd / Very strong performance in the first half of
2016 - enhanced by successfulUptravi US launch . Processed and transmitted by
NASDAQ OMX Corporate Solutions.The issuer is solely responsible for the
content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND -
21 July 2016
-
Actelion Ltd (SIX: ATLN) today announced its results for the first six months
of 2016.

OPERATING HIGHLIGHTS

* Excellent Opsumit®(macitentan) trajectory and new patient referrals
sustained
* Continued outstanding US launch momentum for Uptravi®(selexipag), Q2
launches in Germany, Canada (private market) and France (cohort ATU)
* Initiation of Phase III study to evaluate the efficacy and safety of
long-term use of macitentan (Opsumit) for the treatment of children with
PAH
* Initiation of Phase II program with new dual orexin receptor antagonist for
the treatment of insomnia

FINANCIAL HIGHLIGHTS

* Sales of CHF 1,179 million (+13% at CER) - portfolio transformation well
underway
* Opsumit sales grow to CHF 378 million
* Uptravi sales of CHF 90 million
* US GAAP operating income of CHF 412 million (+12% at CER)
* Core operating income of CHF 499 million (+11% at CER)
* 2016 financial guidance upgrade: core operating income growth in the
low-teen percentage range, at constant exchange rates and barring
unforeseen events

-------------------------------------------------------------------
| % variance |
| in CHF million H1 2016 H1 2015 in CHF at CER(1) |
| |
|(except for per share data) |
| US GAAP results |
| Net revenue 1,180 1,011 17 13 |
| Operating income 412 344 20 12 |
| Net income 361 287 25 17 |
| Diluted EPS 3.32 2.50 33 23 |
| Core performance |
|(2) |
| Product sales 1,179 1,008 17 13 |
| Core operating income 499 423 18 11 |
| Core net income 440 357 23 16 |
| Core diluted EPS 4.05 3.11 30 23 |
-------------------------------------------------------------------

-----------------------------------------------------
| Cash flow H1 2016 H1 2015 |
| Operating cash flow 420 278 |
| Capital expenditure -31 -11 |
| Free cash flow 14 -540 |
| Net cash position as of 30 June 418 430 |
-----------------------------------------------------
1 CER percentage changes are calculated by reconsolidating both the H1 2015
and H1 2016 results at constant currencies (the average monthly exchange
rates for H1 2015).
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 have had an excellent first half year, mainly driven by the
strong performance of both Opsumit and Uptravi. We have also made significant
progress with our development pipeline by initiating a Phase III long-term
study with macitentan for the treatment of children with PAH and a Phase II
program with our new dual orexin receptor antagonist. All in all, the
transformation of the company is well underway and I am very pleased with our
achievements. What's more, I am confident that we can sustain this momentum
moving forward."

Otto Schwarz, Chief Operating Officer,
commented: "The strong uptake of Uptravi is the result of the robust clinical
data generated with this innovative drug, combined with our strong commercial
capabilities to launch specialty therapies. Sales reached 90 million Swiss
francs for the first six months of the year with about 1,150 patients
benefiting from Uptravi at the end of June. Along with the continued strong
Opsumit launch momentum and the Veletri growth, the transformation of our PAH
portfolio is progressing well, with almost half of the second quarter 2016
sales stemming from our new outcome-based therapies."

André C. Muller, Chief Financial Officer,
commented: "The balance of sales growth with disciplined R&D investment in the
company's future has resulted in double-digit US GAAP and core operating
income growth. Based on this excellent first half year, along with more
clarity on a number of factors, including the strong Opsumit and Uptravi
launch dynamics, stable pricing in Japan for Opsumit and Tracleer, and the
unlikely entry of generic competition for Tracleer in the US in 2016, the
company has increased the outlook for the full year. Barring unforeseen
events, we now expect 2016 core operating income growth in the low-teen
percentage range at constant exchange rates."

SALES UPDATE

Actelion delivered an outstanding first half 2016, driven by a very strong
Uptravi launch in the US and the continued successful uptake of Opsumit. The
excellent performance of the company's outcome-based PAH portfolio is the
result of consistently strong referrals of new PAH patients across markets,
as well as an increase in the number of patients benefitting from double and
triple combination PAH therapy.

In the US, sales increased by 25% at CER, driven by the strong Uptravi launch,
continued Opsumit momentum and ERA market share gains. European sales were 1%
lower at CER, despite increased Opsumit uptake and Tracleer use in the
digital ulcer indication, due to continued pricing pressure and market
erosion from generics, particularly in Spain. Sales in Japan increased by 20%
at CER, mostly driven by very strong sales of Opsumit (launched in June
2015), Veletri and Zavesca (Japanese trade name Brazaves).

Comparing average exchange rates for the first six months of 2016 to the first
six months of 2015, the Swiss franc weakened, mostly against the US dollar,
euro and Japanese yen, resulting in a positive currency variance of 39
million Swiss francs.

Sales by product - H1 2016

---------------------------------------------------------
| % variance |
| in CHF millions H1 2016 H1 2015 in CHF at CER |
| Opsumit® 378 208 82 76 |
| Tracleer® 546 645 -15 -18 |
| Uptravi® 90 - nm nm |
| Veletri® 48 38 24 19 |
| Ventavis® 43 57 -24 -27 |
| Valchlor® 18 12 49 43 |
| Zavesca® 52 44 17 15 |
| Others 4 3 17 22 |
| Total product sales 1 ,179 1,008 17 13 |
---------------------------------------------------------
Sales by product - Q2 2016

---------------------------------------------------------
| % variance |
| in CHF millions Q2 2016 Q2 2015 in CHF at CER |
| Opsumit® 200 113 77 71 |
| Tracleer® 256 301 -15 -19 |
| Uptravi® 56 - nm nm |
| Veletri® 24 19 24 18 |
| Ventavis® 17 26 -35 -37 |
| Valchlor® 9 7 24 20 |
| Zavesca® 27 25 8 6 |
| Others 2 2 13 15 |
| Total product sales 590 493 20 15 |
---------------------------------------------------------
Sales by region - H1 2016

-------------------------------------------------------
| % variance |
| in CHF millions H1 2016 H1 in CHF at CER |
| 2015 |
| United States 639 495 29 25 |
| Europe* 322 318 1 -1 |
| Japan 116 86 34 20 |
| Rest of the world 102 109 -6 -3 |
| Total product sales 1,179 1,008 17 13 |
-------------------------------------------------------
*Europe = EU28 and Switzerland

Sales by region - Q2 2016

---------------------------------------------------------
| % variance |
| in CHF millions Q2 2016 Q2 2015 in CHF at CER |
| United States 313 243 29 25 |
| Europe* 158 155 1 -3 |
| Japan 66 45 48 29 |
| Rest of the world 54 50 8 10 |
| Total product sales 590 493 20 15 |
---------------------------------------------------------
*Europe = EU28 and Switzerland

PAH FRANCHISE
Opsumit®

Sales of Opsumit (macitentan) amounted to 378 million Swiss francs for the
first six months of 2016, an increase of 76% at CER compared to the first six
months of 2015. This increase continues to be driven by the uptake trajectory
with commercial availability in over 30 countries. The strong increase in
patients benefitting from Opsumit is driven by referral of treatment-naïve
patients together with increased early combination with PDE-5 inhibitors, and
some switching from Tracleer, notably in Japan.

Uptravi®

Sales of Uptravi (selexipag) amounted to 90 million Swiss francs for the first
six months of 2016. Of this total amount, approximately 30 million Swiss
francs can be attributed to the build-up of the US launch inventory as 10
different presentations of the drug across the various doses were made
available. Uptravi has been fully launched in the US since 4 January 2016 and
in Germany since 15 June 2016.

During the second quarter 2016, Uptravi also became available in France under
a cohort ATU and in Canada for the private market segment. At the end of
June, about 1,150 patients were using this outcome-based, oral selective IP
receptor agonist.

Tracleer®

Sales of Tracleer (bosentan) amounted to 546 million Swiss francs for the
first six months of 2016, a decrease of 18% at CER compared to the first six
months of 2015. This d...

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