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Media Release
21 July 2015
Actelion delivers excellent first half 2015 results
ALLSCHWIL/BASEL, SWITZERLAND – 21 July 2015 – Actelion Ltd (SIX: ATLN) today
announced its results for the first six months of 2015.
OPERATING HIGHLIGHTS
 Opsumit® – Sales of CHF 208 million, increased patient recruitment momentum
 Opsumit – Launched in Japan and Spain in June 2015
 Selexipag (Uptravi®) – FDA, EMA regulatory procedures on track
 Specialty franchise – Immunology portfolio advances
 Creation of vaccine start-up Vaxxilon – Innovating together with Max Planck Society
FINANCIAL HIGHLIGHTS
 Product sales of CHF 1,008 million – Strong growth driven by Opsumit uptake
 Core earnings of CHF 423 million – Driven by commercial performance
 2015 financial guidance upgrade: Mid- to high-teen percentage core earnings growth
at CER (ex 2014 US rebate reversals)
 Return to shareholders: CHF 680 million via share repurchase program and dividend
% variance
in CHF millions
H1 2015
H1 2014
in CHF
at CER(1)
1,011
993
2
4
Operating income
344
347
-1
4
Net income
287
420
-32
-28
Diluted EPS
2.50
3.62
-31
-27
Product sales
1,008
993
2
4
Core earnings
423
421
0
4
Core earnings ex 2014 US rebate reversals
423
368
15
19
Core net income
357
378
-5
0
Diluted core EPS
3.11
3.25
-4
1
(except for per share data)
US GAAP results
Net revenue
Core performance(2)
page 2 of 10
H1 2015
H1 2014
Operating cash flow
278
259
Capital expenditure
(11)
(12)
(540)
63
430
970
in CHF millions
Cash flow
Free cash flow (3)
Net cash position
(1)
(2)
(3)
CER percentage changes are calculated by reconsolidating both the H1 2014 and H1 2015 results at constant
currencies (the average monthly exchange rates for H1 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.
Free cash flow is reconciled with the change in net cash position and consequently includes share purchases of
CHF 715 million during the first half of 2015 (H1 2014: CHF 392 million).
Jean-Paul Clozel, MD, Chief Executive Officer, commented: “We have had an excellent
first half of the year with continued strong demand for our PAH products, boosted by
Opsumit. Our effort to establish additional specialty franchises from our R&D pipeline, in
particular in the field of immunology, is progressing well. We have also been actively
pursuing our share repurchase program in order to ensure continued value creation for
shareholders. All in all, we have delivered on all key elements of our strategy.”
Otto Schwarz, Chief Operating Officer, commented: “We continue to be extremely pleased
with the performance of Opsumit as it drives not only sales growth but also an expansion
of the ERA market as a whole. Patient recruitment remains strong in all markets where
available and at end of June more than 9,800 patients were already profiting from the
long-term outcome benefits of Opsumit.”
André C. Muller, Chief Financial Officer, commented: “Excellent execution across the
commercial organization along with disciplined management of the business resulted in
very good half year results. On the back of this strong performance, we are very happy to
once again upgrade guidance for the full year. We now expect that, unforeseen events
excluded, core earnings will increase in the mid- to high-teen percentage range, at CER
and excluding prior year US rebate reversals.”
HALF YEAR REPORT
Full details on the progress made during the first six months of 2015 are available in
Actelion's 2015 Half Year Report, available from www.actelion.com.
UPCOMING EVENTS


9M 2015 Financial Results reporting on 20 October 2015
FY 2015 Financial Results reporting on 9 February 2016
###
- First Half 2015 Financial Results -
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NOTES TO THE EDITOR
BUSINESS REVIEW
Dear Shareholders,
Once again, I am pleased to present an excellent progress report for Actelion. The first half of 2015 has seen
continued strong demand for our pulmonary arterial hypertension (PAH) products. Growth has been driven by
the strong uptake of Opsumit® (macitentan): the launch momentum has been sustained as the roll-out is
extended to additional countries. Excitement is building as the registration process advances for our next big
opportunity – selexipag (Uptravi®), the first selective oral IP prostacyclin receptor agonist. The first scientific
presentations of results from the pivotal Phase III outcome study, GRIPHON, were met with great enthusiasm,
which bodes well for the future growth of our PAH business.
This year, we have made significant progress with our efforts to develop additional specialty franchises from
our R&D pipeline, focusing on opportunities in the field of immunology and antibiotics. We have also been
actively pursuing our share repurchase program so as to ensure continued value creation for shareholders.
EXCELLENT FIRST HALF OF 2015
Our key financial performance indicators all demonstrate the strength of our business, with product sales
rising to just over 1 billion Swiss francs (+11% at CER, excluding prior-year US rebate reversals). Core
earnings increased to 423 million Swiss francs (+19% at CER, excluding prior-year US rebate reversals),
resulting in core earnings per share (EPS) of 3.11 Swiss francs.
As product sales continue to exceed our forecasts, we are upgrading our financial guidance for the full year
2015.
SUSTAINING AND GROWING THE PAH FRANCHISE
With further launches of Opsumit – notably in Japan and Spain – our PAH portfolio continues to go from
strength to strength. Just over 18 months after the first launch, at the end of June more than 9,800 patients
were already profiting from the long-term outcome benefits of Opsumit, which generated sales of 208 million
Swiss francs in the first half of 2015. This is a very strong performance in a competitive environment.
At launch, one target group has been newly diagnosed (treatment-naive) patients, and in many countries
Opsumit has achieved a leading share in this segment within the first 12 months on the market. A second
target group has been patients already receiving PDE5 inhibitor monotherapy. Clearly, physicians are
increasingly recognizing the outcome evidence from SERAPHIN and moving to combination therapy –
Opsumit plus a PDE5 inhibitor. As a result, combination therapy is growing in many markets where Opsumit is
available, with the US, Germany and the UK leading the way – driving overall growth of our endothelin
receptor antagonist (ERA) business.
Demand for Tracleer remains strong in markets where Opsumit is not yet available and also in Europe, thanks
to the digital ulcer indication and the pediatric formulation. Sales for the first half of 2015 amounted to 645
million Swiss francs. Following the Pediatric Investigation Plan (PIP) compliance statement from the European
- First Half 2015 Financial Results -
page 4 of 10
Committee for Medicinal Products for Human Use (CHMP), applications for extension of the Supplementary
Protection Certificate (SPC) were filed in 19 EU countries, and the first extensions of patent protection for
Tracleer have already been granted.
The last month of the first half of 2015 also saw the successful launch of Veletri in France – a very important
market for i.v. epoprostenol. Overall, Veletri continues to grow strongly, increasing its share of the i.v.
epoprostenol market in all countries where it is available.
As announced last year, selexipag – discovered by our partners at Nippon Shinyaku – was shown to be
effective in a large Phase III outcome study with PAH patients: the risk of a morbidity/mortality event was
reduced by 40% (p<0.0001) versus placebo. The result is particularly impressive considering 80% of patients
were already receiving an oral PAH treatment – with one third receiving an ERA combined with a PDE5
inhibitor. The tolerability of selexipag was consistent with therapies targeting the prostacyclin pathway.
In March 2015, data on selexipag from the GRIPHON study were presented at the American College of
Cardiology congress, where they were enthusiastically received. Since then, scientific presentations have also
been given at the International Society for Heart & Lung Transplantation meeting in Europe and at the
American Thoracic Society conference. Feedback from clinicians on the data has been very encouraging.
Regulatory dossiers for selexipag were filed with the EMA and the FDA at the end of 2014, and further filings
have taken place this year. The regulatory procedures are on track for first marketing authorization decisions
by the end of this year or early in 2016; all the necessary resources are being made available to support the
regulatory process.
We also aim to extend the clinical utility of both macitentan and selexipag beyond PAH into the broader
pulmonary hypertension setting, as well as in other promising indications. The results from the Phase II study
in combined pre- and post-capillary pulmonary hypertension due to left ventricular dysfunction (CpcPH-LVD)
with macitentan are expected before the end of the year. While we were disappointed with the results of our
exploratory study of selexipag in Raynaud’s phenomenon secondary to systemic sclerosis (the efficacy data
do not support further pursuit of this indication), our search for other potential indications will continue. In the
meantime, of course, we are focusing on the registration process for selexipag in PAH.
BUILDING ADDITIONAL SPECIALTY FRANCHISES
Our ongoing success in PAH has enabled us to make significant progress with the second element of our
strategy. In particular, we have taken action to build an additional specialty franchise in immunology. Our
thorough understanding of the clinical potential of selective S1P 1 receptor modulation, together with advances
in the field of immunology, has given us the confidence to advance two of our compounds into multiple
therapeutic areas.
Following a broad scientific, medical and commercial evaluation, we have initiated Phase III development of
our lead compound ponesimod in patients with relapsing multiple sclerosis. In parallel, we have initiated a
Phase II study with ponesimod in patients suffering from chronic graft-versus-host disease. In addition, a
- First Half 2015 Financial Results -
page 5 of 10
second selective S1P1 receptor modulator will advance into Phase II clinical development in patients with
systemic lupus erythematosus.
In the Phase III development program to assess the efficacy and safety of our novel antibiotic cadazolid in
Clostridium difficile-associated diarrhea, patient recruitment has now surpassed a third of the planned total.
With almost 200 sites on board around the world, the recruitment rate is increasing, which should make it
possible to complete enrollment by the end of 2016.
The promising innovations resulting from our R&D efforts make us confident that we can realize our ambition
to build additional specialty franchises. Apart from organic growth opportunities, Actelion has clearly indicated
its interest in acquisitions that would create further value for our shareholders. Should an opportunity be
identified in the marketplace through our ongoing evaluation activities, the Actelion Board of Directors will not
hesitate to act swiftly and decisively.
Other approaches to value creation for shareholders are also being pursued. One example is the recent
creation, together with the Max Planck Society, of a new company in the field of synthetic carbohydrate
vaccines – an exciting opportunity with great potential, which could become a commercial reality within the
next decade. This investment represents an innovative way of finding synergies between the worlds of
academia and industry.
Our specialty products on the market continue to contribute to overall growth, with total specialty product sales
amounting to 60 million Swiss francs.
OPTIMIZING PROFITABILITY – UPGRADED GUIDANCE
One result of our commitment to maintain and increase profitability is the substantial returns achieved for
shareholders. At this year’s Annual General Meeting, you approved an increased dividend of CHF 1.30 per
registered share, which was paid out in May. In addition to the ongoing first-line share purchase program
designed to service employee stock ownership plans, we have been pursuing a new second-line share
repurchase program (up to 10 million shares within three years); here, over 4 million shares have already
been purchased.
With a strong first-half sales performance, mainly driven by intrinsic growth, we expect to deliver higher
profitability in 2015 than originally forecast; as a result, we are raising our full year guidance. Barring
unforeseen events, we now expect 2015 core earnings growth to be in the mid- to high-teen percentage range
(at CER, excluding the impact of 2014 US rebate reversals).
VALUE CREATION
In recent years, we have created significant value as an independent company, but I believe we are only
beginning to realize Actelion’s full potential. Our leading PAH portfolio, our financial discipline, and the
progress we have made in building additional specialty franchises all combine to paint a bright future for
Actelion – for our patients and their physicians, for our employees, and for our shareholders. Thank you for
joining us on this exciting journey, which is making a difference to so many people’s lives.
- First Half 2015 Financial Results -
page 6 of 10
Yours sincerely,
Jean-Paul Clozel, Chief Executive Officer
SALES UPDATE
Actelion’s commercial performance in the first six months of 2015 was strong, driven by the continued
successful uptake of Opsumit, consistently strong recruitment of new patients across markets, and ERA
market expansion due to increased combination therapy with PDE5 inhibitors. In the US, sales increased by
21% at CER (excluding 2014 rebate reversals), driven by Opsumit momentum and ERA market share gains,
as well as price increases across major products. European sales increased by 1% at CER, driven mostly by
Opsumit launches and Tracleer growth in the digital ulcer indication, and impacted by some price erosion.
Sales in Japan increased by 3% at CER, driven by sales of Veletri and Zavesca (Japanese trade name
Brazaves®). Sales in the rest of the world increased by 12% at CER, driven by strong growth in emerging PAH
markets such as the Middle East, China and Taiwan and the successful launch of Opsumit in Australia.
Comparing average exchange rates for the first half of 2015 with those for the first half of 2014, the Swiss
franc appreciated against most major currencies, resulting in a negative currency variance of 26 million Swiss
francs.
Sales by product – year-to-date
% variance
H1 2015
H1 2014
in CHF
at CER
Opsumit®
208
53
nm
nm
Tracleer®
in CHF millions
645
741
-13
-9
Veletri®
38
30
29
32
Ventavis®
57
54
6
0
Valchlor®
12
3
nm
nm
Zavesca®
44
52
-15
-9
3
2
50
59
1,008
934
8
11
-
58
1,008
993
2
4
Others
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
Sales by product – quarterly
% variance
in CHF millions
Q2 2015
Q2 2014
in CHF
at CER
Opsumit®
113
38
nm
nm
Tracleer®
301
372
-19
-14
Veletri®
19
16
19
23
Ventavis®
26
29
-11
-16
Valchlor®
7
2
nm
nm
Zavesca®
25
27
-8
0
2
1
67
79
493
484
2
6
-
40
Others
Total product sales ex US
rebate reversals
US rebate reversals
- First Half 2015 Financial Results -
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Total product sales
493
524
-6
-3
Sales by region – year-to-date
% variance
H1 2015
H1 2014
in CHF
at CER
United States
495
383
29
21
Europe
329
368
-11
1
Japan
86
92
-6
3
Rest of the world
97
91
8
12
1,008
934
8
11
-
58
1,008
993
2
4
Q2 2015
Q2 2014
in CHF
at CER
United States
243
210
16
9
Europe
161
189
-15
-2
Japan
45
43
4
16
Rest of the world
45
42
7
13
493
484
2
6
-
40
493
524
-6
-3
in CHF millions
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
Sales by region – quarterly
% variance
in CHF millions
Total product sales ex US
rebate reversals
US rebate reversals
Total product sales
Opsumit®
Sales of Opsumit (macitentan) amounted to 208 million Swiss francs for the first half of 2015, reflecting the
continued highly successful launch. The strong patient recruitment trend continued during the first half of 2015
with just over 9,800 patients on drug at the end of June with the contribution from Tracleer patient switches in
early launch markets decreasing. The strong enrollment is driven by a significant market share of ERA naïve
patients combined with early combination with PDE5 inhibitors. In June 2015, Opsumit was launched in Japan
(where it is co-promoted with Nippon Shinyaku) and Spain. As per June 30, 2015, Opsumit was available to
patients in 30 countries around the globe.
Tracleer®
Sales of Tracleer (bosentan) amounted to 645 million Swiss francs for the first half of 2015, a decrease of 9%
at CER compared to the first half of 2014 excluding 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 growing competitive pressures in Japan. Tracleer sales
were supported by price increases in the US, the digital ulcer indication in Europe and continued solid demand
in markets where Opsumit is not yet available. Underlying units sold globally decreased by 7%.
- First Half 2015 Financial Results -
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Veletri®
Sales of Veletri (epoprostenol for injection) amounted to 38 million Swiss francs for the first half of 2015, an
increase of 32% at CER compared to the first half of 2014 excluding the impact of prior-year US rebate
reversals. The increase was mostly driven by increased market penetration, successful launches in additional
markets and continued growth in Japan despite a price cut of 5% on March 1, 2014. In June 2015, Veletri
became available to patients in France, the biggest European i.v. epoprostenol market in terms of prostacyclin
patients. At the end of June 2015, Veletri was available in 15 countries around the globe.
Ventavis®
Sales of Ventavis (iloprost) amounted to 57 million Swiss francs for the first half of 2015, unchanged at CER
compared to the first half of 2014, or 8% lower including the impact of prior-year US rebate reversals. The
underlying unit decrease of 20%, due to continued competitive pressure, was offset by price increases.
Specialty Products
Valchlor®
Sales of Valchlor (mechlorethamine) for the first half of 2015 amounted to 12 million Swiss francs. The
company is continuing its efforts to establish Valchlor as an option in the treatment algorithm for early-stage
MF-CTCL. In France almost 200 patients benefitted from the drug under temporary authorization for use
(“ATU”) program initiated during the second half of 2014.
In addition, in the second quarter of 2015, the company filed the dossier for Valchlor (under the trade name
Ledaga®) with the EMA. The dossier has been accepted and is under review.
Zavesca®
Sales of Zavesca (miglustat) amounted to 44 million Swiss francs for the first half of 2015, a decrease of 9% at
CER compared to the first half of 2014 excluding the impact of prior-year rebate reversals. Underlying units
sold decreased by 4%. Sales in the US were lower mainly due to competitive pressure in type 1 Gaucher
disease. Outside the US, Zavesca sales were almost stable with increased patient demand in the NiemannPick type C indication (particularly in Japan where it is marketed as Brazaves ®), offset by the launch of generic
miglustat, which has become commercially available (approved for the type 1 Gaucher disease indication
only) in Spain, Sweden and the Czech Republic.
CLINICAL UPDATE
As announced on 16 April 2015, the company is accelerating its clinical development efforts in the field of
immunological disorders, following a broad scientific, medical and commercial evaluation of a series of its
selective S1P1 receptor modulators, discovered in-house.
Actelion has initiated Phase III development with ponesimod, its lead compound, in patients suffering from
relapsing multiple sclerosis, with patient enrollment expected imminently.
In parallel, Actelion will also initiate a Phase II study with ponesimod in patients suffering from chronic graft
versus host disease. In addition, a second selective S1P 1 receptor modulator will advance into Phase II
clinical development in patients with systemic lupus erythematosus.
- First Half 2015 Financial Results -
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During the first half of 2015, a new chemical entity entered into man for neurological disorders. Other projects
in the clinical development pipeline are progressing according to plan.
Clinical Development Pipeline
Phase
Compound
Indication
Study
Status
Registration
Selexipag
PAH
GRIPHON
Submissions
ongoing
III
Cadazolid
Clostridium difficile-associated
diarrhea
IMPACT
Ongoing
III
Macitentan
Eisenmenger syndrome
MAESTRO
Ongoing
III
Ponesimod
Multiple sclerosis
OPTIMUM
Ongoing
II
Macitentan
Chronic thromboembolic pulmonary
hypertension
MERIT
Ongoing
II
Macitentan
Combined pre- and post-capillary
pulmonary hypertension
MELODY
Ongoing
II
Ponesimod
Graft-versus-host disease
-
Ongoing
II
S1P1 modulator
Systemic lupus erythematosus
-
Ongoing
Ib
Lucerastat
Fabry disease
-
Ongoing
I
Macitentan
Glioblastoma
-
Ongoing
I
NCE
Cardiovascular disorders
-
Ongoing
I
NCE
Neurological disorders
-
Ongoing
RECONCILIATION US GAAP TO CORE RESULTS FOR THE FIRST HALF OF 2015
To access the reconciliation table for the first half of 2015 click here
RECONCILIATION US GAAP TO CORE RESULTS FOR THE SECOND QUARTER OF 2015
To access the reconciliation table for the second quarter of 2015 click here
- First Half 2015 Financial Results -
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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 has treatments approved by health
authorities for a number of specialty 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 2,400 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 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
- First Half 2015 Financial Results -