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2016-02-09

Actelion Pharmaceuticals Ltd: Actelion presents outstanding 2015 results - Company transformation progressing well

Actelion Pharmaceuticals Ltd / Actelion presents outstanding 2015 results -
Company transformation progressingwell . Processed and transmitted by NASDAQ
OMX Corporate Solutions.The issuer is solely responsible for the content of
this announcement.
ALLSCHWIL/BASEL, SWITZERLAND -
09 February 2016
-
Actelion Ltd (SIX: ATLN) today announced its results for the full year 2015.

OPERATING HIGHLIGHTS

* Opsumit - Strong, sustained launch trajectory across markets
* Uptravi - Approved and launched in the US
* Uptravi - EU filing resulted in positive CHMP opinion
* Pipeline - Advancing late-stage assets
* Pipeline - Significant progress in discovery and early-stage development

FINANCIAL HIGHLIGHTS

* Product sales cross CHF 2 billion - driven by excellent Opsumit sales (CHF
516 m)
* Core earnings of CHF 814 million, up 14% at CER (up 25% ex US rebate
reversals)
* Core EPS of CHF 6.16, an increase of 15% at CER
* Almost CHF 1 billion returned to shareholders through share repurchase and
dividend
* Board to propose increased dividend of CHF 1.50
* 2016 guidance: Low single-digit percentage core operating income growth at
CER

------------------------------------------------------------------------------
| % variance |
| in CHF millions 2015 2014 in CHF at CER(1) |
| |
|(except for per share data) |
| US GAAP results |
| Net revenue 2,045 1,958 4 7 |
| Operating income 656 570 15 21 |
| Net income 552 594 -7 -3 |
| Diluted EPS 4.91 5.11 -4 1 |
| Core performance |
|(2) |
| Product sales 2,042 1,956 4 7 |
| Core earnings 814 743 9 14 |
| Core earnings ex 2014 US rebate reversals 814 677 20 25 |
| Core net income 693 648 7 11 |
| Diluted core EPS 6.16 5.58 10 15 |
------------------------------------------------------------------------------

--------------------------------------------
| Cash flow 2015 2014 |
| Operating cash flow 658 616 |
| Capital expenditure (44) (31) |
| Cash returned shareholders 927 133 |
| Free cash flow (800) 327 |
| Net cash position 405 1,205 |
--------------------------------------------
1 CER percentage changes are calculated by reconsolidating both the 2014 and
2015 results at constant currencies (the average monthly exchange rates for
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: "2015 was an
outstanding year for Actelion, with record sales and earnings. More
importantly for me, these outstanding financial results have been accompanied
by significant transformation of the company. With the impressive take-off of
Opsumit and with Uptravi now on the market, we have a great platform to build
and invest in our future. We have transformed our PAH portfolio and the
diversification of our pipeline is well underway. As a result, we now have
the opportunity to become the first European-born biopharma to make it to the
major league."

Otto Schwarz, Chief Operating Officer, commented: "The excellent launch
momentum of Opsumit, across all markets, has resulted in more than 13,600
patients on therapy at the end of 2015. Following the US approval of Uptravi
and subsequent launch in January of this year, we are now working diligently
to ensure more patients can benefit from this novel treatment targeting the
prostacyclin pathway. With Opsumit, Uptravi and Veletri, we are uniquely
positioned to build and serve the PAH community, covering the continuum of
care with outcome-based medicines."

André C. Muller, Chief Financial Officer, commented: "Actelion has delivered
an excellent performance in 2015. Our commercial operations have delivered
sales of more than 2 billion Swiss francs, despite the sudden appreciation of
the Swiss franc in January 2015. This strong performance along with tight
financial discipline demonstrated the earnings power of our business with
core earnings growing more than twice as fast as sales."

Barring unforeseen events, Actelion forecasts 2016 core operating income, at
constant exchange rates, to grow in the low single-digit percentage range.
This expectation involves a number of assumptions including Opsumit and
Uptravi launch dynamics, generic pressures mainly in the US and pricing
pressure in Europe and Japan.

KEY PERFORMANCE INDICATORS

PRODUCT SALES

Actelion's excellent commercial performance during 2015 was mainly due to the
continued strong uptake of Opsumit, driven by consistently strong recruitment
of new patients across markets and expansion of the endothelin receptor
antagonist (ERA) market due to increased combination therapy with PDE-5
inhibitors.
In the US, sales increased by 21% at CER, excluding 2014 rebate reversals, and
were driven by Opsumit uptake, ERA market share gains and ERA market
expansion, as well as price increases across the portfolio. European sales
increased by 3% at CER despite continued pricing pressure and market erosion
from generics, with growth driven mostly by new Opsumit markets and use of
Tracleer in the digital ulcer indication.
Sales in Japan increased by 11% at CER in a competitive environment. Growth
was driven by sales of Opsumit (launched in late June 2015), Tracleer in the
digital ulcer indication (launched in September 2015), Veletri and Zavesca
(Japanese trade name Brazaves®).

Comparing average exchange rates for 2015 with 2014, the Swiss franc
appreciated against most major currencies except the US dollar, resulting in
a negative currency variance of 55 million Swiss francs.

PAH franchise

Opsumit®

Sales of Opsumit (macitentan) amounted to 516 million Swiss francs, reflecting
a sustained highly successful launch. Opsumit is now available to patients in
over 35 countries and gaining ERA market share in all geographies. Strong
patient demand continued, with more than 13,600 patients on therapy at the
end of December 2015 (almost 50% from the US). Patient growth was driven by
an increasing market share in the ERA-naive patient segment and increased
combination with PDE-5 inhibitors, as well as new market launches (e.g.
Japan, Israel).

Tracleer®

Sales of Tracleer (bosentan) amounted to 1,212 million Swiss francs, a
decrease of 11% at CER excluding 2014 US rebate reversals. This decrease is
mostly attributed to lower volumes in countries where Opsumit is available,
due to sharply decreased enrollment of new patients. Sales were further
impacted by continued pricing pressure in Europe and increased generic
bosentan competition. Underlying units sold globally decreased by 6%.

Following the Pediatric Investigation Plan (PIP) compliance statement from the
European Committee for Medicinal Products for Human Use (CHMP), applications
for extension of the Supplementary Protection Certificate (SPC) were filed in
19 EU countries. Extensions of patent protection for Tracleer have now been
granted in Belgium, Denmark, Finland, France, Italy, Ireland, Luxembourg, the
Netherlands, Spain and Sweden.

Tracleer sales were positively supported by the digital ulcer (DU) indication
in Europe and Japan (launched in September 2015), a price increase in the US
and continued solid demand in markets where Opsumit is not yet available.
Overall, more than 46,000 patients were receiving the drug globally at the
end of 2015 (a decrease of 9% versus prior year).

Veletri®

Sales of Veletri (epoprostenol for injection) amounted to 83 million Swiss
francs, an increase of 37% at CER, excluding 2014 US rebate reversals, with
over 1,900 patients receiving the drug at the end of 2015. The increase was
mostly driven by increased market penetration, successful launches in
additional markets - notably in France, Europe's biggest i.v. epoprostenol
market - and continued growth in Japan. At the end of December 2015, Veletri
was available in 15 countries worldwide.

Ventavis®

Sales of Ventavis (iloprost) amounted to 105 million Swiss francs, a decrease
of 7% at CER, excluding the impact of prior year US rebate reversals. The
underlying 20% unit decrease due to continued competitive pressure was
mitigated by price increases.

Specialty Products

Valchlor®

Sales of Valchlor (mechlorethamine) amounted to 27 million Swiss francs. In
the US, the company is continuing its efforts to establish Valchlor as a
first-line option in the treatment algorithm for early-stage mycosis
fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

In France, patients benefited from the drug under a temporary authorization
for use ("ATU") program initiated during the second half of 2014. The dossier
for Valchlor (under the trade name Ledaga®) was accepted by the European
Medicines Agency during the second quarter of 2015 and is currently under
review.

Zavesca®

Sales of Zavesca (miglustat) amounted to 92 million Swiss francs, a decrease
of 3% at CER, excluding the impact of prior year US rebate reversals.
Underlying unit sales were flat compared to the prior year.

Sales in the US declined mainly as a result of competitive pressure from
alternative enzyme replacement therapy (ERT) options for the type 1 Gaucher
disease (GD1) indication. In Europe, a decline in the GD1 business due to
generic competition in selected markets was mitigated by increased patient
demand in the Niemann-Pick type C indication, driven by Japan (where it is
marketed as Brazaves®), Italy, France and Russia. At the end of 2015, generic
miglustat (approved for GD1 only) was commercially available in Spain,
Sweden, Germany and the Czech Republic.

CORE R&D EXPENDITURE

Core R&D expenses amounted to 404 million Swiss franc...

Författare WKR

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