Actelion on track to deliver double digit LC core earnings growt
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Actelion Pharmaceuticals Ltd /
Actelion on track to deliver double digit LC core earnings growt
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ALLSCHWIL/BASEL, SWITZERLAND - 17 October 2013 - Actelion Ltd (SIX: ATLN) today
announced financial results for the first nine months of 2013.
OPERATING HIGHLIGHTS
* Macitentan (Opsumit(®)) - US regulatory decision imminent
* Ceptaris acquisition finalized - US Valchlor launch in Q4 2013
* Veletri (epoprostenol for injection) launched in Japan, Canada, UK and NL
* Phase III with cadazolid in Clostridium difficile-associated diarrhea (CDAD)
initiated
FINANCIAL HIGHLIGHTS
* Product sales of CHF 1,322 million, an increase of 4% in local currencies
* Core earnings of CHF 496 million, an increase of 14% in local currencies
* Guidance confirmed - FY core earnings growth to cross into double digits in
local currencies
* Core EPS of CHF 3.60, an increase of 21% in local currencies
* CHF 800 million share repurchase program completed
| Results | Results | Variance | Variance
| 9M 2013 | 9M 2012 | in CHF | in LC
In CHF million | | | |
(except for per share data) | | | |
------------------------------+---------+---------+----------+----------
Product sales | 1,322 | 1,299 | 2% | 4%
------------------------------+---------+---------+----------+----------
Core earnings | 496 | 444 | 12% | 14%
------------------------------+---------+---------+----------+----------
Operating income | 397 | 359 | 11% | 14%
------------------------------+---------+---------+----------+----------
Core EPS (fully diluted) | 3.60 | 3.09 | 17% | 21%
| | | |
As of 30 September 2013, Actelion had cash and cash deposits of CHF 1,398
million (of which CHF 616 million is restricted). In addition, Actelion holds
9.4 million treasury shares.
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "I am very pleased
with the progress Actelion is making in pursuing its strategy for value
creation, with Core EPS local currency growth at 21 percent for the first nine
months of 2013. We are maintaining and growing our Pulmonary Arterial
Hypertension (PAH) franchise, as evidenced by increasing product sales and
macitentan (Opsumit) nearing the end of the regulatory review period in both the
United States and the European Union. The Phase III program for selexipag in PAH
also is on track to report data in mid-2014."
Jean-Paul Clozel concluded: "With the acquisition of Ceptaris, we have broadened
our product portfolio. Together with the Phase III initiation for our new
antibiotic agent cadazolid, we are advancing in creating additional product
franchises."
Otto Schwarz, Chief Operating Officer, commented: "Once regulatory approval is
obtained, Actelion's commercial organization is fully prepared to globally make
macitentan (Opsumit) available to patients and their care givers. Whilst we
prepared for the imminent macitentan launch, we have continued to manage our
existing business, with product sales of 1,322 million Swiss Francs, an increase
of four percent in local currencies compared to the same period a year ago. This
performance was achieved in what has remained a challenging environment."
André C. Muller, Chief Financial Officer, added: "The solid performance during
the first nine months of 2013 is a testimony to the commitment the company made
to shareholder value creation. We delivered good product sales and we kept our
cost base at a lower level, ahead of product launches and starting new clinical
programs. We are, therefore, well on track to meet our local currency guidance
of core earnings growth crossing into double digit territory for the full year
2013."
Guidance (in local currencies) also remains unchanged for the coming two years.
For 2014, Actelion expects core earnings to be at least at the same level for
2014 as for the current year and for 2015, earnings growth is expected to be at
least in the single-digit percentage range.
André C. Muller concluded: "Actelion continues to generate strong cashflow from
operations, giving us significant financial flexibility to further strengthen
our business, as we have done with the 226 million Swiss Franc acquisition of
Ceptaris in September 2013. Last but not least, the strong cash generation this
year also enabled us to return 530 million Swiss Francs to shareholders through
dividends and the recently concluded share buyback."
Ready for Opsumit
Over the past few months, Actelion has prepared the organization for a
successful global market introduction of macitentan (Opsumit). Actelion is fully
leveraging its existing infrastructure and experience in the field of Pulmonary
Arterial Hypertension.
Regulatory filings are ongoing in the United States and the European Union as
well as in Canada, Switzerland and other territories worldwide. In the US,
Health Authorities are expected to render a decision by the PDUFA date of 19
October 2013. In Europe, approval could occur in early 2014.
At the end of August 2013, the long-term outcome data - upon which these
regulatory filings are based - were published in the New England Journal of
Medicine (Pulido T et al. Macitentan and Morbidity and Mortality in Pulmonary
Arterial Hypertension. N Engl J Med 2013;369:809-18.).
Additional data presentations have been made at numerous medical conferences,
such as in September at the European Society of Cardiology (ESC) and European
Respiratory Society (ERS). Both publications and presentations were met with
strong interest by the medical community.
Acquisition of Ceptaris Therapeutics, Inc.
In mid-September 2013, Actelion concluded the acquisition of Ceptaris
Therapeutics, Inc. following approval by the US Food and Drug Administration
(FDA) of Valchlor(®) (mechlorethamine) gel 0.016% for topical treatment of stage
IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in patients
who have received prior skin-directed therapy.
Valchlor (mechlorethamine) gel 0.016% is indicated for the topical treatment of
stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (CTCL) in
patients who have received prior skin-directed therapy. Valchlor gel is applied
topically once-a-day and dries on the skin. The availability of Valchlor allows
US physicians to treat mycosis fungoides type CTCL with an FDA-approved
formulation of topical mechlorethamine. In addition to consistent, controlled
manufacturing processes, Valchlor will be provided with labeling that includes
data and instructions for correct use, to help achieve the best possible
clinical results.
Actelion will make Valchlor(®) available in the US during the fourth quarter of
2013, using a dedicated sales force and will evaluate the opportunity outside
the US, before filing for registration in other regions.
Preliminary purchase price allocation resulted in an increase in intangible
assets of USD 378 million, goodwill of USD 109 million, a deferred tax liability
of USD 151 million and a contingent consideration of USD 87 million.
PRODUCT SALES FOR 9M 2013
In CHF million | Results | Results | Variance | Variance
| 9M 2013 | 9M 2012 | in CHF | in LC
----------------------+---------+---------+----------+-----------
Tracleer | 1,138 | 1,131 | 1% | 3%
----------------------+---------+---------+----------+-----------
Ventavis | 83 | 85 | -2% | -2%
----------------------+---------+---------+----------+-----------
Veletri | 25 | 18 | 42% | 47%
----------------------+---------+---------+----------+-----------
Zavesca | 73 | 62 | 17% | 17%
----------------------+---------+---------+----------+-----------
Others | 3 | 2 | 21% | 25%
----------------------+---------+---------+----------+-----------
Total product sales | 1,322 | 1,299 | 2% | 4%
| | | |
PRODUCT SALES REVIEW
Tracleer(®) (bosentan) sales amounted to CHF 1,138 million for the first nine
months of 2013, an increase of 3% in local currencies compared to the same
period in 2012. This performance was mainly driven by a 5% increase in units
shipped, impacted by some phasing of wholesaler orders and positive pricing in
the US.
Ventavis(®) (iloprost) had sales in the US of CHF 83 million for the first nine
months of 2013, a decrease of 2% in local currencies compared to the same period
in 2012. Ventavis continues to be impacted by competitive pressure while
benefiting from positive price movement.
Veletri(®) (epoprostenol for injection) sales amounted to CHF 25 million for the
first nine months of 2013, an increase of 47% in local currencies compared to
the same period in 2012. In the United States, Veletri continues to gain share
in the epoprostenol market. In Japan, Veletri has performed strongly since its
market introduction in late June 2013.
Zavesca(®) (miglustat) sales amounted to CHF 73 million for the first nine
months of 2013, an increase of 17% in local currencies compared to the same
period in 2012. This performance was driven predominantly by strong ex-US
patient demand in the Niemann-Pick Type C indication and positive price movement
in the US.
CORE OPERATING EXPENSES AND CORE EARNINGS
In CHF million | Results | Results | Variance | Variance
(except per share data) | 9M 2013 | 9M 2012 | In CHF | In LC
---------------------------+---------+---------+----------+----------
Product Sales | 1,322 | 1,299 | 2% | 4%
---------------------------+---------+---------+----------+----------
Core operating expenses | 827 | 855 | -3% | -1%
---------------------------+---------+---------+----------+----------
Core Earnings | 496 | 444 | 12% | 14%
---------------------------+---------+---------+----------+----------
Core EPS (fully diluted) | 3.60 | 3.09 | 17% | 21%
---------------------------+---------+---------+----------+----------
Cost of sales for the first nine months of 2013 amounted to CHF 154 million, an
increase of 5 % in local currencies compared to the same period in 2012.
Core R&D expenses, which exclude stock-based compensation expense and
amortization and depreciation, were CHF 251 million for the first nine months of
2013, a decrease of 12% in local currencies compared to the same period of 2012
as a result of the cost savings initiative.
Core SG&A expenses, which exclude stock-based compensation expense,
amortization, depreciation and the impact of doubtful debt provisions, were CHF
421 million compared to CHF 417 million in the first nine months of 2012, an
increase of 4% in local currencies.
Core earnings amounted to CHF 496 million for the first nine months of 2013
compared to CHF 444 million during same period in 2012, an increase of 14% in
local currencies driven by solid underlying operational performance.
Fully diluted core earnings per share were CHF 3.60 for the first nine months of
2013, an increase of 21% in local currencies compared to the same period of
2012.
Starting in Q4 2013, Actelion expects a moderate increase in R&D expenses with
the start of new clinical programs, such as new indications for macitentan and
the Phase III program for the novel oral antibiotic agent cadazolid in patients
with Clostridium difficile-associated diarrhea (CDAD). Additional spending for
the global launch of macitentan will be limited, as the company is fully
leveraging its existing infrastructure and knowhow in the field of Pulmonary
Arterial Hypertension.
OPERATING EXPENSES AND OPERATING INCOME
In CHF million | Results | Results | Variance | Variance
| 9M 2013 | 9M 2012 | in CHF | in LC
---------------------+---------+---------+----------+----------
Total Net Revenue | 1,324 | 1,303 | 2% | 4%
---------------------+---------+---------+----------+----------
Operating expenses | 927 | 944 | -2% | 0%
---------------------+---------+---------+----------+----------
Operating Income | 397 | 359 | 11% | 14%
| | | |
Total operating expenses were CHF 927 million for the first nine months of 2013
compared to CHF 944 million during the same period in 2012, a decrease of 2%.
Research and Development (R&D) expenses were CHF 287 million in the first nine
months of 2013, a decrease of 14% compared to the same period of 2012 (CHF 334
million).
Selling, General and Administrative expenses (SG&A) were CHF 442 million for the
first nine months of 2013, an increase of 2% compared to CHF 432 million during
the same period in 2012, as the company prepared for the imminent launch of
Opsumit(®).
Operating income for the first nine months of 2013 was CHF 397 million compared
to CHF 359 million for the same period in 2012, an increase of 11%. In local
currencies operating income increased by 14%.
NET INCOME
In CHF million | Results | Results | Variance | Variance
(except per share data) | 9M 2013 | 9M 2012 | in CHF | in LC
--------------------------+---------+---------+----------+----------
Operating Income | 397 | 359 | 11% | 14%
--------------------------+---------+---------+----------+----------
Financial expense | 40 | 41 | -3% | na
--------------------------+---------+---------+----------+----------
Tax expense | 52 | 49 | na | na
--------------------------+---------+---------+----------+----------
Net Income | 304 | 268 | 13% | 17%
--------------------------+---------+---------+----------+----------
Fully diluted EPS | 2.65 | 2.26 | 17% | 21%
--------------------------+---------+---------+----------+----------
Financial expense amounted to CHF 40 million during the first nine months of
2013, compared to CHF 41 million for the same period of 2012. This expense is
mainly related to the interest on the litigation provision (CHF 30 million) and
the interest expense on the CHF 235 million bond (CHF 9 million).
Tax expense amounted to CHF 52 million, which translates into a tax rate for the
first nine months of 2013 of 14.7%.
Net income amounted to CHF 304 million for the first nine months of 2013 (9M
2012: CHF 268 million). This represents an increase of 13% in Swiss Franc terms
or 17% in local currencies.
US GAAP earnings per share on a fully diluted basis in the first nine months of
2013 increased to CHF 2.65 from CHF 2.26 in the same period last year.
Completion of share buyback program
In August 2013, the company finished the CHF 800 million share buyback program
announced in October 2010.
In 2013, the company bought back shares for a total of CHF 417 million. In
total, Actelion repurchased 17.1 million of its own shares via a second trading
line on the SIX Swiss Exchange for an average purchase price per share of CHF
46.85.
This buyback represented 13.3% of the issued shares at the time of the start of
the share repurchase in October 2010.
The Ordinary General Meeting 2014 will decide upon a capital reduction through
cancellation of the remaining 6.1 million repurchased shares, which have not yet
been cancelled.
NON-GAAP TO US GAAP RECONCILIATION FOR 9M 2013
In CHF million | 9M 2013 | 9M 2012
----------------------------------------+---------+---------
Product sales | 1,322 | 1,299
----------------------------------------+---------+---------
Core operating expenses | -827 | -855
----------------------------------------+---------+---------
Core earnings excluding impact of DDP | 496 | 444
----------------------------------------+---------+---------
Movement in doubtful debt provision | 10 | 22
----------------------------------------+---------+---------
Contract revenues | 1 | 5
----------------------------------------+---------+---------
Stock option expenses | -37 | -36
----------------------------------------+---------+---------
Amortization and depreciation | -58 | -62
----------------------------------------+---------+---------
Arbitration settlement | -13 |
----------------------------------------+---------+---------
Auxilium milestone payment | | -9
----------------------------------------+---------+---------
Restructuring costs | -1 | -5
----------------------------------------+---------+---------
US GAAP Operating Income | 397 | 359
| |
CORE EPS CALCULATION
In CHF million | 9M 2013 | 9M 2012
----------------------------------+---------+---------
Core earnings | 496 | 444
----------------------------------+---------+---------
Non-GAAP financial result | -10 | -10
----------------------------------+---------+---------
Adjusted income before tax | 485 | 433
----------------------------------+---------+---------
Tax | -71 | -67
----------------------------------+---------+---------
Adjusted net income | 414 | 366
----------------------------------+---------+---------
Number of shares in calculation | 115 | 119
----------------------------------+---------+---------
Core EPS (in CHF) | 3.60 | 3.09
| |
UPCOMING EVENTS
* Macitentan regulatory decisions
* Global Macitentan launch
* Valchlor launch in the US
* FY Financial Results 2013 reporting - 11 February 2014
* Annual General Meeting - 8 May 2014
* Selexipag Phase III results - Mid-2014
###
NOTES TO EDITORS
ABOUT ACTELION LTD.
Actelion Ltd is a biopharmaceutical company with its corporate headquarters in
Allschwil/Basel, Switzerland. Actelion's first drug Tracleer®, an orally
available dual endothelin receptor antagonist, has been approved as a therapy
for pulmonary arterial hypertension. Actelion markets Tracleer® through its own
subsidiaries in key markets worldwide, including the United States (based in
South San Francisco), the European Union, Japan, Canada, Australia and
Switzerland.
Founded in late 1997 Actelion is a leading player in innovative science related
to the endothelium - the single layer of cells separating every blood vessel
from the blood stream. Actelion's over 2,300 employees focus on the discovery,
development and marketing of innovative drugs for significant unmet medical
needs. 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®).
For further information please contact:
Roland Haefeli
Senior Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
www.actelion.com
Conference Call Information
Actelion Ltd will announce the Nine months 2013 financial results on Thursday,
17 October 2013, at 07.00 hrs CEST / 06.00 hrs BST / 01.00 a.m. EDT. An investor
conference call & webcast will be held at 14.00 hrs, CEST to discuss the
results.
Date/Time:
17 October 2013 14.00 hrs Basel (CEST)
13.00 hrs UK (BST)
08.00 a.m US (EDT)
Conference Call Connect #:
Dial-in participants should start calling the number below 10-15 minutes before
the conference is due to start.
Dial: Europe: +41 (0)44 580 00 74
UK: +44 (0)203 367 94 54
US: +1 866 9075 924
Participant's mode: Listen-Only with possibility to open individual lines during
Q&A session.
Participants will be asked for their Name and Company.
Webcast Access:
Webcast participants should visit the Actelion website http://www.actelion.com
10-15 minutes before the conference is due to start.
Participant's mode: Listen-Only
Webcast Replay:
The archived Investor Webcast will be available for replay through
http://www.actelion.com approximately 60 minutes after the call has ended.
Press Release PDF:
http://hugin.info/131801/R/1736135/581772.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/1736135/581774.pdf
Financial Statement:
http://hugin.info/131801/R/1736135/581777.pdf
Webcast:
http://view-w.tv/p/120-121-13508/en
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters 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 Thomson Reuters ONE
[HUG#1736135]
Unternehmensinformation / Kurzprofil:
Datum: 17.10.2013 - 07:00 Uhr
Sprache: Deutsch
News-ID 306595
Anzahl Zeichen: 25130
contact information:
Town:
Allschwil
Kategorie:
Business News
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