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2016-10-20

Actelion Pharmaceuticals Ltd: Excellent operational results - supported by outstanding Uptravi launch - financial guidance upgraded

Actelion Pharmaceuticals Ltd / Excellent operational results - supported by
outstanding Uptravi launch -financial guidance upgraded . Processed and
transmitted by Nasdaq Corporate Solutions.The issuer is solely responsible
for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND -
20 October 2016
-
Actelion Ltd (SIX: ATLN) today announced its results for the first nine months
of 2016.

OPERATING HIGHLIGHTS

* Strong Opsumit®(macitentan) trajectory and quarterly net new patient gains
sustained
* Excellent US launch momentum for Uptravi®(selexipag) - enhanced by launches
in Germany and the Netherlands
* Uptravi®(selexipag) approvals in Switzerland and Japan (by Nippon Shinyaku)
in Q3
* First all-oral combination therapy with ponesimod and dimethyl fumarate
(Tecfidera®) to be evaluated for patients with relapsing multiple sclerosis

FINANCIAL HIGHLIGHTS

* Sales growing to CHF 1,785 million (+14% at CER) - New PAH products surpass
Tracleer for the first time
* Opsumit sales grow to CHF 596 million (+63% at CER)
* Uptravi sales reach CHF 160 million after just 9 months on the market
* US GAAP operating income grows to CHF 660 million (+17% at CER)
* Core operating income grows to CHF 781 million (+14% at CER)
* 2016 financial guidance upgraded: core operating income growth in the
mid-teen percentage range, at constant exchange rates and barring
unforeseen events

-------------------------------------------------------------------
| % variance |
| in CHF million 9M 2016 9M 2015 in CHF at CER(1) |
| |
|(except for per share data) |
| US GAAP results |
| Net revenue 1,791 1,525 17% 14% |
| Operating income 660 533 24% 17% |
| Net income 581 452 29% 21% |
| Diluted EPS 5.37 3.99 35% 27% |
| Core performance |
|(2) |
| Product sales 1,785 1,522 17% 14% |
| Core operating income 781 651 20% 14% |
| Core net income 691 560 23% 17% |
| Core diluted EPS 6.38 4.94 29% 23% |
-------------------------------------------------------------------

----------------------------------------------------------
| Cash flow 9M 2016 9M 2015 |
| Operating cash flow 695 533 |
| Capital expenditure (45) (17) |
| Free cash flow 6 (506) |
| Net cash position as of 30 September 411 698 |
----------------------------------------------------------
1 CER percentage changes are calculated by reconsolidating both the 9M 2015
and 9M 2016 results at constant currencies (the average monthly exchange
rates for 9M 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: "Once again, we have delivered a very strong performance across
all areas of our business. I am particularly happy with the very positive
feedback we receive from physicians prescribing Uptravi. We have also made
considerable progress advancing our innovative pipeline, highlighted by the
recent initiation of the combination study with ponesimod in relapsing
multiple sclerosis. In summary, the transformation of the company is well
under way."

Otto Schwarz, Chief Operating Officer,
commented: "We continue to be extremely pleased with the transformation of our
PAH portfolio. For the first time, in the third quarter, more than 50% of our
sales came from our new outcome-based PAH portfolio. The strong uptake of
Uptravi in the US continued during the third quarter, enhanced by a strong
early trajectory in Germany, resulting in a total of over 1,800 patients
benefiting from this novel oral therapy at the end of September 2016."

André C. Muller, Chief Financial Officer,
commented: "The excellent commercial performance has enabled us to increase
our R&D effort to advance both the late and earlier stage pipeline, whilst
continuing to deliver strong earnings growth. Our focus on the bottom line,
coupled with strong sales enables us to increase guidance. Barring unforeseen
events, we now expect 2016 core operating income growth in the mid-teen
percentage range at constant exchange rates."

SALES UPDATE

Actelion's strong performance continued during the third quarter of 2016
driven by the outstanding Uptravi launch in the US and Opsumit's ongoing
growth dynamics. For the first time, during the third quarter of 2016, sales
of the company's outcome-based PAH portfolio, Opsumit, Uptravi and Veletri,
exceeded 50% of total sales, demonstrating the extent of the transformation
of the PAH franchise.

In the US, sales increased by 23% at CER, driven by the strong Uptravi launch,
continued Opsumit momentum and ERA market share gains. European sales were at
the same level as 2015, despite increased Opsumit uptake and Tracleer use in
the digital ulcer indication, but mitigated by 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), Tracleer in digital ulcer indication, Veletri and Zavesca
(Japanese trade name Brazaves).

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

Sales by product - 9M 2016

---------------------------------------------------------
| % variance |
| in CHF millions 9M 2016 9M 2015 in CHF at CER |
| Opsumit® 596 354 68 63 |
| Tracleer® 790 934 -15 -18 |
| Uptravi® 160 - nm* nm |
| Veletri® 71 60 18 13 |
| Ventavis® 58 81 -28 -31 |
| Valchlor® 26 19 34 30 |
| Zavesca® 78 68 15 13 |
| Others 6 5 12 14 |
| Total product sales 1,785 1,522 17 14 |
---------------------------------------------------------
*nm = not meaningful

Sales by product - Q3 2016

---------------------------------------------------------
| % variance |
| in CHF millions Q3 2016 Q3 2015 in CHF at CER |
| Opsumit® 218 147 49 45 |
| Tracleer® 244 289 -16 -18 |
| Uptravi® 70 - nm nm |
| Veletri® 23 22 7 2 |
| Ventavis® 15 24 -39 -40 |
| Valchlor® 8 7 10 8 |
| Zavesca® 26 24 11 9 |
| Others 2 2 1 -1 |
| Total product sales 606 514 18 15 |
---------------------------------------------------------
Sales by region - 9M 2016

---------------------------------------------------------
| % variance |
| in CHF millions 9M 2016 9M 2015 in CHF at CER |
| United States 964 766 26 23 |
| Europe* 485 475 2 0 |
| Japan 182 132 38 20 |
| Rest of the world 155 149 4 6 |
| Total product sales 1,785 1,522 17 14 |
---------------------------------------------------------
*Europe = EU28 and Switzerland

Sales by region - Q3 2016

---------------------------------------------------------
| % variance |
| in CHF millions Q3 2016 Q3 2015 in CHF at CER |
| United States 325 271 20 18 |
| Europe* 163 157 3 3 |
| Japan 66 45 45 20 |
| Rest of the world 52 40 30 29 |
| Total product sales 606 514 18 15 |
---------------------------------------------------------
*Europe = EU28 and Switzerland

PAH FRANCHISE

Opsumit®

Sales of Opsumit (macitentan) amounted to 596 million Swiss francs for the
first nine months of 2016, an increase of 63% at CER compared to the first
nine months of 2015. This increase continues to be driven by new patient
starts with commercial availability in over 30 countries. The continued
increase in patients benefitting from Opsumit is driven by referral of
treatment-naïve patients together with increased use in combination with
PDE-5 inhibitors, and some upgrades from Tracleer, notably in Japan.

Uptravi®

Sales of Uptravi (selexipag) amounted to 160 million Swiss francs for the
first nine months of 2016. Since the US launch at the beginning of January
2016, patient demand has continued to increase with sales of 126 million
Swiss francs (excluding initial inventory build of 30 million Swiss francs).
For the third quarter, revenues from patient demand in the US amounted to 66
million Swiss francs compared to 45 million Swiss francs in the second
quarter and 15 million Swiss francs in the first quarter of 2016. Uptravi was
successfully launched in Germany in mid-June 2016 with sales reaching 3
million Swiss francs in an underdeveloped market in terms of prostacyclin
usage. At the end of September, about 1,800 patients were using Uptravi
globally.

During the third quarter 2016, Uptravi was approved in Switzerland and Japan
(where it will be co-promoted by Nippon Shinyaku, who will record the sales)
pending pricing and reimbursement approval.

Tracleer®

Sales of Tracleer (bosentan) amounted to 790 million Swiss francs for the
first nine months of 2016, a decrease of 18% at CER compared to the first
nine months of 2015, equally dr...

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