Actelion delivers excellent results in the first quarter 2015
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion delivers excellent results in the first quarter 2015
. Processed and transmitted by NASDAQ OMX Corporate Solutions.
The issuer is solely responsible for the content of this announcement.
ALLSCHWIL/BASEL, SWITZERLAND - 21 April 2015 - Actelion Ltd (SIX: ATLN) today
announced its results for the first quarter of 2015.
OPERATING HIGHLIGHTS
* Opsumit (macitentan) - Q1 2015 sales of CHF 95 million
* Opsumit (macitentan) - approved in Japan in March 2015
* Selexipag (Uptravi) - GRIPHON data presented at American College of
Cardiology
* Selexipag (Uptravi) - FDA, EMA regulatory procedures on track
* Specialty franchise - Immunology portfolio advances
FINANCIAL HIGHLIGHTS
* Product sales of CHF 515 million - strong growth driven by Opsumit uptake
* Core earnings of CHF 218 million - increased operational leverage
* Core EPS of CHF 1.61 - delivering value to shareholders
* Strong performance drives 2015 financial guidance upgrade - now expecting
low double-digit percentage core earnings growth at CER (ex 2014 US rebate
reversals)
------------------------------------------------------------------------------
% variance
--------------------
in CHF millions Q1 2015 Q1 2014 in CHF at CER((1))
(except for per share data)
------------------------------------------------------------------------------
US GAAP results
------------------------------------------------------------------------------
Net revenue 515 469 10 12
------------------------------------------------------------------------------
Operating income 190 153 24 28
------------------------------------------------------------------------------
Net income 159 128 25 29
------------------------------------------------------------------------------
Diluted EPS 1.38 1.09 26 30
------------------------------------------------------------------------------
Core performance((2))
------------------------------------------------------------------------------
Product sales 515 469 10 12
------------------------------------------------------------------------------
Core earnings 218 189 15 18
------------------------------------------------------------------------------
Core earnings ex 2014 US rebate reversals 218 172 26 29
------------------------------------------------------------------------------
Core net income 185 170 9 11
------------------------------------------------------------------------------
Diluted core EPS 1.61 1.46 10 12
------------------------------------------------------------------------------
Cash flow
-----------------------------------------------------------
Operating cash flow 94 96
-----------------------------------------------------------
Capital expenditure (7) (6)
-----------------------------------------------------------
Free cash flow (57) 88
-----------------------------------------------------------
Net cash position 913 731
-----------------------------------------------------------
1. CER percentage changes are calculated by reconsolidating both the Q1 2014
and Q1 2015 results at constant currencies (the average monthly exchange
rates for Q1 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: "We had an excellent
start to 2015 and I am particularly pleased with the continued strong demand for
Opsumit. The selexipag data presentation was very well received at the American
College of Cardiology congress, and the regulatory procedures are on track. As
recently announced, we also made significant progress to build a robust
specialty pipeline by advancing our immunology portfolio. Based on the first
quarter results I am confident that we are going to surpass our full year
targets and we are therefore increasing our guidance."
Otto Schwarz, Chief Operating Officer, commented: "With sales of 95 million
Swiss francs during the first quarter of 2015, Opsumit's strong launch momentum
continues across all markets, increasing our ERA market share. Moreover, our
overall first quarter sales performance across the portfolio has been very
satisfying, mainly driven by intrinsic growth, but also enhanced by buying
pattern variations. We are also progressing with launch preparations for Opsumit
in additional markets such as Japan and Spain."
André C. Muller, Chief Financial Officer, commented: "We are very pleased with
the excellent start to the year. The strong intrinsic performance and increased
visibility on business dynamics enable us to significantly increase guidance for
2015. We are now confident that, barring unforeseen events, core earnings growth
for 2015 will be in the low double-digit percentage range, at constant exchange
rates and excluding the benefit of 2014 US rebate reversals."
SALES UPDATE
Actelion's strong first quarter 2015 sales performance was driven by the
continued strong Opsumit launch. In the US, sales increased by 36% (ex 2014
rebate reversals) driven by Opsumit, buying pattern variations and price
increases across major products. European sales increased by 5% at CER, driven
mostly by Opsumit, and Tracleer sales in the digital ulcer indication in a
continually negative pricing environment. Sales in Japan decreased by 8% at
constant exchange rates mainly due to reduced inventories compared to the first
quarter of 2014. Sales in the rest of the world increased by 10% at CER, driven
by strong growth in PAH-emerging markets such as China, other Asian and Latin
American markets. Comparing average exchange rates for the first quarter of
2015 with the average exchange rates during the first quarter 2014, the Swiss
franc appreciated against most major currencies, resulting in a negative
currency variance of 9 million Swiss francs or 2%.
Sales by product - year-to-date
---------------------------------------------------------------------------
% variance
--------------
in CHF millions Q1 2015 Q1 2014 in CHF at CER
---------------------------------------------------------------------------
Opsumit 95 15 nm nm
---------------------------------------------------------------------------
Tracleer 344 369 -7% -4%
---------------------------------------------------------------------------
Veletri 19 14 41% 42%
---------------------------------------------------------------------------
Ventavis 31 25 26% 18%
---------------------------------------------------------------------------
Valchlor 5 1 nm nm
---------------------------------------------------------------------------
Zavesca 20 26 -23% -18%
---------------------------------------------------------------------------
Others 2 1 nm nm
---------------------------------------------------------------------------
Total product sales ex US rebate reversals 515 450 14% 16%
---------------------------------------------------------------------------
US rebate reversals - 18
---------------------------------------------------------------------------
Total product sales 515 469 10% 12%
---------------------------------------------------------------------------
Sales by region - year-to-date
---------------------------------------------------------------------------
% variance
--------------
in CHF millions Q1 2015 Q1 2014 in CHF at CER
---------------------------------------------------------------------------
United States 252 173 45% 36%
---------------------------------------------------------------------------
Europe 169 179 -6% 5%
---------------------------------------------------------------------------
Japan 42 49 -16% -8%
---------------------------------------------------------------------------
Rest of the world 53 49 8% 10%
---------------------------------------------------------------------------
Total product sales ex US rebate reversals 515 450 14% 16%
---------------------------------------------------------------------------
US rebate reversals - 18 - -
---------------------------------------------------------------------------
Total product sales 515 469 10% 12%
---------------------------------------------------------------------------
Opsumit(®)
Opsumit (macitentan) sales for the first quarter of 2015 amounted to 95 million
Swiss francs, reflecting the continued successful launch. The strong patient
enrollment trend continued during the first quarter. As per 31 March 2015,
Opsumit was successfully launched in the United States, Germany, Austria, the
UK, Ireland, Denmark, Sweden, the Netherlands, Australia, Italy, Belgium,
Luxembourg, Canada, Finland, Mexico (marketed as Zependo(®)), Norway, Iceland,
Switzerland, Hungary, Kuwait, Portugal and Israel. On 26 March 2015, Opsumit was
approved in Japan. Actelion Pharmaceuticals Japan will locally co-promote
Opsumit with Nippon Shinyaku and the companies will ensure that Opsumit is made
available to patients as soon as possible.
Tracleer(®)
Tracleer (bosentan) sales amounted to 344 million Swiss francs for the first
quarter of 2015, a decrease of 4% at CER compared to the first quarter of 2014
or 8% including 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 a negative
inventory effect in Japan. Tracleer sales were supported by replenished
inventories returning to normalized levels and price increases in the US, the
digital ulcer indication in Europe as well as continued solid demand for
Tracleer in markets where Opsumit is not yet available. Underlying units sold
globally decreased by 5%.
Veletri(®)
Veletri (epoprostenol for injection) sales amounted to 19 million Swiss francs
for the first quarter of 2015, an increase of 42% at CER compared to Q1 2014 or
34% including the impact of prior year US rebate reversals. The increase was
mostly driven by successful launches in additional markets and continued growth
in Japan despite a 5% price cut on 1 March 2014. At the end of March 2015,
Veletri was available in the US, UK, Spain, the Netherlands, Australia, New
Zealand, Portugal, Poland, Belgium, the Czech Republic and Switzerland, in Japan
marketed as Epoprostenol "ACT", and marketed as Caripul(® )in both Canada and
Italy.
Ventavis(®)
During the first quarter of 2015, Ventavis (iloprost) had sales in the US of 31
million Swiss francs, an increase of 18% at CER or 6% including the impact of
prior year US rebate reversals. This increase was driven entirely by price, as
sales volumes eroded by 12% due to competitive pressures.
Specialty Products
Valchlor(®)
Valchlor (mechlorethamine) sales for the first quarter of 2015 amounted to 5
million Swiss francs. The company is making progress in establishing Valchlor as
an option in the treatment algorithm of early stage MF-CTCL. The nominative
Temporary Authorization for Use (ATU) in France, initiated during the second
half of 2014, is progressing well.
Zavesca(®)
Zavesca (miglustat) sales amounted to 20 million Swiss francs for the first
quarter of 2015, a decrease of 18% at CER compared to the first quarter of 2014
or 17% including the impact of prior year rebate reversals. This decrease is
mostly driven by a shift in government purchasing in a number of markets as well
as the launch of generic miglustat in Spain (approved for the Type-1 Gaucher
disease indication only). Patient demand outside the US in the Niemann-Pick type
C indication remains strong, particularly in Japan (where it is marketed as
Brazaves(®)). Underlying units sold decreased by 13%.
A full financial review is available on www.actelion.com
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
S1P(1) 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.
During the first quarter a new chemical entity entered into man for neurological
disorders. Other projects in the clinical development pipeline are progressing
according to plan.
-------------------------------------------------------------------------------
Phase Compound Indication Study Status
-------------------------------------------------------------------------------
III Cadazolid Clostridium difficile- IMPACT Ongoing
associated diarrhea
-------------------------------------------------------------------------------
III Macitentan Eisenmenger syndrome MAESTRO Ongoing
-------------------------------------------------------------------------------
III Ponesimod Multiple sclerosis OPTIMUM Ongoing
-------------------------------------------------------------------------------
III Selexipag PAH GRIPHON Submissions ongoing
-------------------------------------------------------------------------------
II Macitentan Chronic thromboembolic MERIT Ongoing
pulmonary hypertension
-------------------------------------------------------------------------------
Combined pre- and post-
II Macitentan capillary pulmonary MELODY Ongoing
hypertension
-------------------------------------------------------------------------------
II Ponesimod Graft vs. host disease - Ongoing
-------------------------------------------------------------------------------
Raynaud's phenomenon
II Selexipag secondary to systemic - Ongoing
sclerosis
-------------------------------------------------------------------------------
II S1P(1) modulator Systemic lupus - Ongoing
erythematosus
-------------------------------------------------------------------------------
Ib Lucerastat Fabry disease - Ongoing
-------------------------------------------------------------------------------
I Macitentan Glioblastoma - Ongoing
-------------------------------------------------------------------------------
I New Chemical Entity Cardiovascular disorders - Ongoing
-------------------------------------------------------------------------------
I New Chemical Entity Neurological disorders - Ongoing
-------------------------------------------------------------------------------
RECONCILIATION US GAAP TO CORE RESULTS FOR THE FIRST QUARTER 2015
---------------------------------------------------------------------------------------------------------------------
(in CHF Depreciation,
millions, amortization Doubtful Milestones Litigation
except per US GAAP and Stock-based debt or or Accretion Core
share amounts) results impairment compensation movements contract arbitration expense results
---------------------------------------------------------------------------------------------------------------------
Net revenue
---------------------------------------------------------------------------------------------------------------------
Product sales 515 - - - - - - 515
---------------- --------- --------------- -------------- ----------- ------------ ------------- ----------- --------
Contract
revenue 1 - - - (1) - - -
---------------------------------------------------------------------------------------------------------------------
Total net
revenue 515 - - - (1) - - 515
---------------------------------------------------------------------------------------------------------------------
Operating
(expenses)
---------------------------------------------------------------------------------------------------------------------
Cost of sales (43) - - - - - (8) (51)
---------------- --------- --------------- -------------- ----------- ------------ ------------- ----------- --------
Research and
development (109) 6 6 - - - - (97)
---------------- --------- --------------- -------------- ----------- ------------ ------------- ----------- --------
Selling,
general and
administration (158) 3 7 0 - - - (149)
---------------- --------- --------------- -------------- ----------- ------------ ------------- ----------- --------
Amortization
of acquired
intangible
assets (15) 15 - - - - - -
---------------------------------------------------------------------------------------------------------------------
Total
operating
(expenses) (326) 24 12 0 - - (8) (297)
---------------------------------------------------------------------------------------------------------------------
Operating
results 190 24 12 0 (1) - (8) 218
---------------------------------------------------------------------------------------------------------------------
Total
financial
results (7) - - - - - - (7)
---------------------------------------------------------------------------------------------------------------------
Income before
income tax
benefit
(expense) 183 24 12 0 (1) - (8) 211
---------------------------------------------------------------------------------------------------------------------
Income tax
benefit
(expense) (24) (3) 0 0 0 - - (26)
---------------------------------------------------------------------------------------------------------------------
Net results 159 21 13 0 (0) - (8) 185
---------------------------------------------------------------------------------------------------------------------
Diluted net
income (loss)
per share 1.38 0.18 0.11 0.00 (0.00) - (0.07) 1.61
---------------- --------- --------------- -------------- ----------- ------------ ------------- ----------- --------
Weighted-
average number
of common
shares (in
thousands) 115.350 - - - - - - 115.350
---------------------------------------------------------------------------------------------------------------------
(1 )Rounding differences may occur
NOTE TO SHAREHOLDERS:
The Annual General Meeting (AGM) of Shareholders to approve the Business Report
of the year ending
31 December 2014 will be held on 8 May 2015. In order to attend and vote at the
Annual General Meeting of Shareholders, shareholders must be registered in the
Company's shareholder register by 27 April 2015 at the latest.
UPCOMING EVENTS
* Annual General Meeting 2015 on 08 May 2015
* HY 2015 Financial Results reporting on 21 July 2015
* 9M 2015 Financial Results reporting on 20 October 2015
###
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 Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com
Press Release PDF:
http://hugin.info/131801/R/1912588/682676.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/1912588/682678.pdf
Webcast:
http://view-w.tv/p/120-121-15626/en
Financial Report incl. US GAAP 1st Quarter:
http://hugin.info/131801/R/1912588/682679.pdf
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via GlobeNewswire
[HUG#1912588]
Unternehmensinformation / Kurzprofil:
Datum: 21.04.2015 - 07:00 Uhr
Sprache: Deutsch
News-ID 387103
Anzahl Zeichen: 27972
contact information:
Town:
Allschwil
Kategorie:
Business News
Diese Pressemitteilung wurde bisher 162 mal aufgerufen.
Die Pressemitteilung mit dem Titel:
"Actelion delivers excellent results in the first quarter 2015"
steht unter der journalistisch-redaktionellen Verantwortung von
Actelion Pharmaceuticals Ltd (Nachricht senden)
Beachten Sie bitte die weiteren Informationen zum Haftungsauschluß (gemäß TMG - TeleMedianGesetz) und dem Datenschutz (gemäß der DSGVO).
