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Media Release
09 February 2016
Actelion presents outstanding 2015 results – Company
transformation progressing well
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)
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
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
(except for per share data)
US GAAP results
Net revenue
Core performance(2)
page 2 of 9
Cash flow
2015
2014
Operating cash flow
658
616
Capital expenditure
(44)
(31)
Cash returned shareholders
927
133
(800)
327
405
1,205
Free cash flow
Net cash position
(1)
(2)
CER percentage changes are calculated by reconsolidating both the 2014 and 2015 results at constant currencies
(the average monthly exchange rates for 2014).
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.
- Full Year 2015 Financial Results -
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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).
- Full Year 2015 Financial Results -
page 4 of 9
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 francs, an increase of 10% at CER. This increase was
driven by higher clinical trial expenses, as the company is advancing its specialty immunology portfolio,
macitentan life-cycle extensions and other late-stage pipeline assets, as well as continued investment in the
earlier-stage pipeline. Core R&D expenditure represented 20% of product sales, slightly higher than in 2014.
Actelion will continue to focus on carefully balancing investments so as to ensure future growth and delivery of
appropriate shareholder returns.
- Full Year 2015 Financial Results -
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CORE EARNINGS
Core operating income amounted to 814 million Swiss francs, an increase of 14% at CER. Excluding the
impact of prior-year US rebate reversals, core operating income increased by 25% at CER. The strength of
the Swiss franc against most currencies except the US dollar had a negative impact of 32 million Swiss francs
on core operating income.
CORE EPS
Diluted core earnings per share were CHF 6.16 for the full year 2015, an increase of 15% at CER compared to
the same period of 2014.
DELIVERING VALUE TO SHAREHOLDERS
Actelion has continued to make significant progress in delivering on its strategy for value creation. The year’s
highlights include the continued very successfully Opsumit launch as well as the FDA approval of Uptravi. A
strong commercial performance, combined with tight financial oversight, was reflected in Actelion’s share
price: with an increase of 21%, the company was one of the top performers on the Swiss Market Index (SMI).
Including the dividend, total shareholder return amounted to 22%. Market capitalization at the end of 2015 was
15.9 billion Swiss francs.
In 2012, Actelion made a commitment to return significant capital to shareholders. The company has delivered
on that promise, with over 2 billion Swiss francs being returned to shareholders in the form of dividends and
share repurchase programs over the past four years. The Board of Directors will also propose an increased
annual dividend payment of CHF 1.50 for approval by shareholders at the upcoming Annual General Meeting
in May.
- Full Year 2015 Financial Results -
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PIPELINE UPDATE
Actelion's promising R&D pipeline comprises novel compounds addressing a broad range of diseases,
including cardiovascular and immunological disorders as well as central nervous system disorders and
infectious diseases.
Actelion's late-stage product candidates include the novel antibiotic cadazolid, under investigation for
Clostridium difficile-associated diarrhea (CDAD) and a S1P1 receptor modulator, ponesimod, investigated in
multiple sclerosis.
Phase
Compound
Indication
Study
Status
Registration
Selexipag
PAH
GRIPHON
Regulatory
reviews ongoing
III
Cadazolid
Clostridium difficile-associated
diarrhea
IMPACT
Ongoing
III
Macitentan
Eisenmenger syndrome
MAESTRO
Ongoing
III
Ponesimod
Multiple sclerosis
OPTIMUM
Ongoing
II
Clazosentan
Reversal of vasospasm associated
with aneurysmal subarachnoid
hemorrhage
REVERSE
Initiating
II
Endothelin
Receptor
Antagonist
Specialty cardiovascular disorders
-
Initiating
II
Macitentan
Chronic thromboembolic pulmonary
hypertension
MERIT
Ongoing
II
Macitentan
Combined pre- and post-capillary
pulmonary hypertension
MELODY
Complete
II
Ponesimod
Graft-versus-host disease
-
Ongoing
II
Cenerimod
Systemic lupus erythematosus
-
Ongoing
Ib
Lucerastat
Fabry disease
-
Ongoing
I
NCE
Neurological disorders
-
Ongoing
I
NCE
Neurological disorders
-
Ongoing
I
NCE
Cardiovascular disorders
-
Ongoing
HUMAN RESOURCES
At the end of 2015, Actelion employed 2,547 permanent employees worldwide, an increase of 3% (or 77
permanent positions) compared to the end of 2014.
- Full Year 2015 Financial Results -
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ANNUAL REPORT
Full details on the progress made in 2015 are available in Actelion's 2015 Annual Report, at
www.actelion.com/annual-report.
NOTES TO SHAREHOLDERS:
The Annual General Meeting (AGM) of Shareholders to approve the Business Report of the year ending
31 December 2015 will be held on 4 May 2016.
At the AGM, the Board of Directors will recommend that shareholders approve a dividend of CHF 1.50 per
share, an increase of 15%.
Shareholders holding more than CHF 1,000,000 nominal value of shares (i.e. 2,000,000 shares at nominal
value of CHF 0.50), being entitled to add items to the agenda of the general meeting of shareholders, are
invited to send in proposals, if any, to Actelion Ltd, attention Corporate Secretary, Gewerbestrasse 16, CH4123 Allschwil, to arrive no later than 18 March 2016. Any proposal received after the deadline will be
disregarded.
In order to attend and vote at the Annual General Meeting of Shareholders, shareholders must be registered
in the company's shareholder register by 22 April 2016 at the latest.
RESULTS DAY CENTER
Investor community: To make your job easier, we provide links to all relevant documentation from the Results
Day Center on our corporate website: www.actelion.com/results-day-center
###
NOTES TO THE EDITOR
Sales by product – year-to-date
% variance
2015
2014
in CHF
at CER
Opsumit®
516
179
nm
nm
®
1,212
1,418
-15
-11
34
37
in CHF millions
Tracleer
Veletri®
83
62
Ventavis®
105
106
-2
-7
Valchlor®
27
11
nm
nm
Zavesca®
92
102
-9
-3
7
6
29
43
2,042
1,883
8
11
4
7
Others
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
73
2,042
1,956
- Full Year 2015 Financial Results -
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Sales by product – quarterly
% variance
Q4 2015
Q4 2014
in CHF
at CER
Opsumit®
162
68
nm
nm
Tracleer®
in CHF millions
278
328
-15
-12
Veletri®
23
18
26
29
Ventavis®
24
26
-9
-11
Valchlor®
8
4
nm
nm
Zavesca®
24
22
8
16
2
2
12
28
519
468
11
14
-
0
519
468
11
14
in CHF millions
2015
2014
in CHF
at CER
United States
1,026
806
27
21
Europe
658
717
-8
3
Japan
190
185
3
11
Rest of the world
168
175
-4
2
2,042
1,883
8
11
4
7
Others
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
Sales by region – year-to-date
% variance
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
73
2,042
1,956
Sales by region – quarterly
% variance
Q4 2015
Q4 2014
in CHF
at CER
United States
259
207
25
22
Europe
166
174
-5
5
Japan
58
49
18
22
Rest of the world
35
37
-6
5
519
468
11
14
-
0
519
468
11
14
in CHF millions
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
- Full Year 2015 Financial Results -
page 9 of 9
UPCOMING EVENTS

3M 2016 Financial Results reporting on 21 April 2016

Annual General Meeting 2016 on 04 May 2016

HY 2016 Financial Results reporting on 21 July 2016
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 also 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 Tcell lymphoma.
Founded in late 1997, with now over 2,500 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 C. 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
The above information contains certain “forward-looking statements”, relating to the company’s business, which can be
identified by the use of forward-looking terminology such as “estimates”, “believes”, “expects”, “may”, “are expected to”,
“will”, “will continue”, “should”, “would be”, “seeks”, “pending” or “anticipates” or similar expressions, or by discussions of
strategy, plans or intentions. Such statements include descriptions of the company’s investment and research and
development programs and anticipated expenditures in connection therewith, descriptions of new products expected to be
introduced by the company and anticipated customer demand for such products and products in the company’s existing
portfolio. Such statements reflect the current views of the company with respect to future events and are subject to certain
risks, uncertainties and assumptions. Many factors could cause the actual results, performance or achievements of the
company to be materially different from any future results, performances or achievements that may be expressed or implied
by such forward-looking statements. Should one or more of these risks or uncertainties materialize, or should underlying
assumptions prove incorrect, actual results may vary materially from those described herein as anticipated, believed,
estimated or expected.
- Full Year 2015 Financial Results -