Actelion delivers strong nine months results
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion delivers strong nine months results
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ALLSCHWIL/BASEL, SWITZERLAND - 20 October 2015 - Actelion Ltd (SIX: ATLN) today
announced its results for the first nine months of 2015.
OPERATING HIGHLIGHTS
* Opsumit (macitentan) - continues strong launch trajectory
* Opsumit (macitentan) - commercially available in over 30 countries including
Japan
* Selexipag (Uptravi(®)) - regulatory procedures on track
* Specialty pipeline - strengthens as several promising compounds advance
FINANCIAL HIGHLIGHTS
* Product sales of CHF 1,522 million - strong growth driven by Opsumit uptake
of
CHF 354 million
* Core earnings of CHF 651 million - increased operational leverage
* 2015 financial guidance upgrade: Crossing the 20% mark for core earnings
growth at CER (excluding 2014 US rebate reversals)
* Return to shareholders: CHF 808 million via share repurchase program and
dividend
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% variance
--------------------
in CHF millions 9M 2015 9M 2014 in CHF at CER((1))
(except for per share data)
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US GAAP results
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Net revenue 1,525 1,490 2% 5%
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Operating income 533 519 3% 7%
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Net income 452 566 -20% -17%
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Diluted EPS 3.99 4.87 -18% -14%
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Core performance((2))
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Product sales 1,522 1,488 2% 5%
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Core earnings 651 630 3% 7%
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Core earnings ex 2014 US rebate reversals 651 563 16% 20%
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Core net income 560 554 1% 5%
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Diluted core EPS 4.94 4.77 4% 7%
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Cash flow 9M 2015 9M 2014
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Operating cash flow 533 455
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Capital expenditure -17 -21
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Free cash flow -506 227
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Net cash position 463 870
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1. CER percentage changes are calculated by reconsolidating both the 9M 2014
and 9M 2015 results at constant currencies (the average monthly exchange
rates for 9M 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: "The transformation of
Actelion is now well underway. Our PAH franchise has evolved from a single
product into a portfolio of outstanding products, which address the continuity
of care in this serious disease. The PAH portfolio should soon be complemented
by selexipag, as regulatory procedures continue on track. Our pipeline outside
PAH is also undergoing a transformation with several promising compounds
advancing in the clinic. Thanks to our financial discipline we are transforming
the company while growing our profitability, allowing us to return significant
value to our shareholders."
Otto Schwarz, Chief Operating Officer, commented: "With sales of 354 million
Swiss francs in the first nine months of this year and almost 11,800 patients on
treatment, Opsumit continues its strong launch momentum, supported by new
launches such as in Japan. As a result, we have seen Actelion gaining share in
the ERA market in addition to expanding the ERA market through more combination
therapy. Based on its comprehensive outcome benefits in mono- and combination
therapy, Opsumit is uniquely positioned to become the ERA of choice across
markets globally."
André C. Muller, Chief Financial Officer, commented: "We are particularly
pleased with the strong third quarter performance as the launch momentum for
Opsumit continues unabated. These strong results give us increased confidence
that earnings will grow more than previously anticipated. Therefore, we now
expect core earnings growth - at constant exchange rates and excluding US rebate
reversals - to cross the 20% mark."
SALES UPDATE
Actelion's commercial performance in the first nine months of 2015 continues to
be strong, driven by the 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. Despite continued pricing
pressure and market erosion from generics, European sales increased by 2% at CER
with growth driven mostly by Opsumit launches and Tracleer use in the digital
ulcer indication. Sales in Japan increased by 7% at CER in a competitive
environment, driven by sales of Opsumit (launched in late June), Veletri and
Zavesca (Japanese trade name Brazaves). Sales in the rest of the world increased
by 1% at CER.
Comparing average exchange rates for the first nine months of 2015 to the first
nine months of 2014, the Swiss franc appreciated against most major currencies
except the US dollar, resulting in a negative currency variance of 40 million
Swiss francs.
Sales by product - year-to-date
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% variance
--------------
in CHF millions 9M 2015 9M 2014 in CHF at CER
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Opsumit(®) 354 111 nm nm
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Tracleer(®) 934 1,090 -14% -10%
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Veletri(®) 60 44 37% 40%
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Ventavis(®) 81 81 1% -5%
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Valchlor(®) 19 7 nm nm
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Zavesca(®) 68 80 -14% -8%
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Others 5 4 38% 50%
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Total product sales ex US rebate reversals 1,522 1,415 8% 10%
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US rebate reversals - 74
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Total product sales 1,522 1,488 2% 5%
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Sales by product - quarterly
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% variance
--------------
in CHF millions Q3 2015 Q3 2014 in CHF at CER
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Opsumit(®) 147 58 nm nm
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Tracleer(®) 289 349 -17% -13%
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Veletri(®) 22 14 53% 58%
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Ventavis(®) 24 27 -11% -16%
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Valchlor(®) 7 3 nm nm
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Zavesca(®) 24 27 -12% -6%
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Others 2 1 18% 35%
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Total product sales ex US rebate reversals 514 480 7% 10%
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US rebate reversals 15
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Total product sales 514 496 4% 6%
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Sales by region - year-to-date
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% variance
--------------
in CHF millions 9M 2015 9M 2014 in CHF at CER
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United States 766 599 28% 21%
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Europe 492 542 -9% 2%
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Japan 132 136 -3% 7%
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Rest of the world 132 138 -4% 1%
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Total product sales ex US rebate reversals 1,522 1,415 8% 10%
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US rebate reversals 74
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Total product sales 1,522 1,488 2% 5%
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Sales by region - quarterly
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% variance
--------------
in CHF millions Q3 2015 Q3 2014 in CHF at CER
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United States 271 215 26% 19%
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Europe 163 174 -7% 4%
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Japan 45 44 4% 16%
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Rest of the world 35 47 -26% -18%
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Total product sales ex US rebate reversals 514 480 7% 10%
--------------------------------------------------------------------------
US rebate reversals 15
--------------------------------------------------------------------------
Total product sales 514 496 4% 6%
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PAH FRANCHISE
Opsumit(®)
Sales of Opsumit (macitentan) amounted to 354 million Swiss francs for the first
nine months of 2015, reflecting the continued highly successful launch, with
commercial availability in over 30 countries. The patient recruitment trend
continued with almost 11,800 patients on drug at the end of September 2015. The
strong enrollment is driven by an increased market share of ERA naïve patients
together with increased early combination with PDE5 inhibitors.
Tracleer(®)
Sales of Tracleer (bosentan) amounted to 934 million Swiss francs for the first
nine months of 2015, a decrease of 10% at CER compared to the first nine months
of 2014 excluding the impact of prior-year US rebate reversals. This decrease is
mostly a consequence of lower volumes in countries where Opsumit is available
due to lower enrollments of new patients as well as switches to Opsumit.
Underlying units sold globally decreased by 7%.Tracleer sales were further
impacted by continued pricing pressure in Europe, increased generic bosentan
competition and competitive pressures in Japan. Positively, Tracleer sales were
supported by the digital ulcer indication in Europe and continued solid demand
in markets where Opsumit is not yet available.
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
Denmark, Finland, France, Ireland, the Netherlands and Sweden.
Veletri(®)
Sales of Veletri (epoprostenol for injection) amounted to 60 million Swiss
francs for the first nine months of 2015, an increase of 40% at CER compared to
the first nine months of 2014 and excluding the impact of prior-year US rebate
reversals. The increase was mostly driven by increased market penetration,
successful launches in additional markets, notably in France - the biggest
European i.v. epoprostenol market in terms of prostacyclin patients - and
continued growth in Japan (where it is marketed as Epoprostenol "ACT"). At the
end of September 2015, Veletri was available in 15 countries globally.
Ventavis(®)
Sales of Ventavis (iloprost) amounted to 81 million Swiss francs for the first
nine months of 2015, a decrease of 5% at CER compared to the first nine months
of 2014, or 11% lower including the impact of prior-year US rebate reversals.
The underlying unit decrease of 22% is due to continued competitive pressure.
SPECIALTY PRODUCTS
Valchlor(®)
Sales of Valchlor (mechlorethamine) for the first nine months of 2015 amounted
to 19 million Swiss francs. In the US, the company is continuing its efforts to
establish Valchlor as an option in the treatment algorithm for early-stage
mycosis fungoides, a type of 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 regulatory dossier is
currently under review with the European Medicines Agency (under the trade name
Ledaga(®)).
Zavesca(®)
Sales of Zavesca (miglustat) amounted to 68 million Swiss francs for the first
nine months of 2015, a decrease of 8% at CER compared to the first nine months
of 2014 excluding the impact of prior-year rebate reversals. Underlying units
sold decreased by 3%. 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 Niemann-Pick type C indication,
particularly in Japan (where it is marketed as Brazaves(®)). Sales were 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.
A full financial review is available on www.actelion.com
CLINICAL 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 disease.
Actelion's late-stage product candidates include the novel antibiotic cadazolid,
under investigation for Clostridium difficile-associated diarrhea (CDAD). The
results from the Phase II study of cadazolid in CDAD were recently published in
two articles covering clinical and microbiological results respectively: T.
Louie et al., A Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating
the Novel Antibiotic, Cadazolid, in Patients with Clostridium difficile
Infection (Antimicrob. Agents Chemother. 2015;59(10):6266-73), and D.N. Gerding
et al., Susceptibility of Clostridium difficile Isolates from a Phase 2 Clinical
Trial of Cadazolid and Vancomycin in C. difficile infection (J. Antimicrob.
Chemother., available online doi:10.1093/jac/dkv300).
Actelion provided a clinical pipeline update in the Half-Year Report, published
on 21 July 2015. All programs are on track with the following updates:
Actelion has initiated a Phase IIIb study, TRITON, to compare the efficacy and
safety of an initial triple oral treatment regimen (macitentan, tadalafil,
selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil,
placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial
hypertension.
Following interactions with regulatory authorities, Actelion has decided to
initiate a limited Phase II study with clazosentan, an intravenous selective
endothelin A receptor antagonist. The study will evaluate whether clazosentan
has an early effect in reversing established cerebral vasospasm in patients with
aneurysmal subarachnoid hemorrhage. The study will be initiated in the coming
months.
Actelion's Phase I cardiovascular compound, a new endothelin receptor
antagonist, is expected to advance into Phase II clinical development in
patients with essential hypertension to establish a dose-effect relationship.
The results from this study will form the basis for development decisions in
specialty cardiovascular disorders.
Finally, a New Chemical Entity has entered into Phase I development for
neurological disorders, adding to our central nervous system pipeline.
DEVELOPMENT PIPELINE
Phase Compound Indication Study Status
-------------------------------------------------------------------------------
Registration Selexipag PAH GRIPHON Regulatory
reviews ongoing
-------------------------------------------------------------------------------
Clostridium
III Cadazolid difficile-associated IMPACT Ongoing
diarrhea
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III Macitentan Eisenmenger syndrome MAESTRO Ongoing
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III Ponesimod Multiple sclerosis OPTIMUM Ongoing
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Reversal of vasospasm
associated with
II Clazosentan aneurysmal - Initiating
subarachnoid
hemorrhage
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Endothelin Specialty
II Receptor cardiovascular - Initiating
Antagonist disorders
-------------------------------------------------------------------------------
Chronic
II Macitentan thromboembolic MERIT Ongoing
pulmonary
hypertension
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Combined pre- and
II Macitentan post-capillary MELODY Ongoing
pulmonary
hypertension
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II Ponesimod Graft-versus-host - Ongoing
disease
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II S1P(1) modulator Systemic lupus - Ongoing
erythematosus
-------------------------------------------------------------------------------
Ib Lucerastat Fabry disease - Ongoing
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I Macitentan Glioblastoma - Ongoing
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I NCE Neurological - Ongoing
disorders
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I NCE Neurological - Initiating
disorders
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UPCOMING EVENTS
* FY2015 Financial Results reporting on 9 February 2016
* Q12016 Financial Results reporting on 21 April 2016
* Annual General Meeting 2016 on 04 May 2016
* HY 2016 Financial Results reporting on 21 July 2016
###
NOTES TO THE EDITOR
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 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 T-cell 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 Communictions
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com
Financial Statements:
http://hugin.info/131801/R/1959773/714309.pdf
Financial Fact sheet:
http://hugin.info/131801/R/1959773/714304.pdf
Press Release PDF:
http://hugin.info/131801/R/1959773/714303.pdf
Webcast:
http://view-w.tv/p/120-121-16405/en
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[HUG#1959773]
Unternehmensinformation / Kurzprofil:
Datum: 20.10.2015 - 07:00 Uhr
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News-ID 427944
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contact information:
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