Actelion Pharmaceuticals Ltd : Actelion delivers strong first quarter 2013
Actelion Pharmaceuticals Ltd / Actelion delivers strong first quarter 2013
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ALLSCHWIL/BASEL, SWITZERLAND - 16 April 2013- Actelion Ltd (SIX: ATLN) today
announced financial results for the first quarter of 2013.
*Macitentan (Opsumit^®) - regulatory procedures on track
*Strong product sales performance
*Veletri (epoprostenol for injection) approved in Japan - decentralized
procedure in Europe successfully concluded with first national approval
*Phase III study with selexipag in PAH (GRIPHON) close to full enrollment -
interim analysis expected in the coming weeks
*Phase III preparation ongoing for ponesimod in psoriasis and for cadazolid
*Product sales of CHF 432.8 million, an increase of 5% in local currencies
*Core earnings of CHF 168.5 million, an increase of 44% in local
*Core EPS of CHF 1.26, an increase of 59% in local currencies
*CHF 800 million share repurchase program on track to be completed by
In CHF Million Results Results % Variance % Variance
(except for per share data) Q1 2013 Q1 2012 In CHF In LC
Product sales 432.8 415.8 4 5
US GAAP Operating income 124.0 67.1 85 86
Core earnings (excluding DDP) 168.5 117.6 43 44
US GAAP EPS (fully diluted) 0.85 0.38 125 127
Core EPS (fully diluted) 1.26 0.80 57 59
As of 31 March 2013, Actelion had cash and cash deposits of CHF 1.6 billion
(of which CHF 628 million is restricted). In addition, Actelion holds 14
million treasury shares.
Jean-Paul Clozel, MD, Chief Executive Officer, commented: "Our PAH portfolio
of products, both on the market and in development, continue to make progress.
Work on our late-stage assets in additional therapeutic areas is making
headway. This progress, together with the strong commercial performance,
clearly demonstrates that we are delivering on all three elements of our
strategy. We strengthen our PAH franchise, we move forward with opportunities
in potential new markets and we do so while optimizing profitability."
Andrew Oakley, Chief Financial Officer, added: "We have delivered a strong
start to 2013. With the preparation of two Phase III studies underway and a
product launch ahead, we will carefully look at guidance for the full year as
it is possible that some of the forecasted profit growth for 2014 could be
brought forward into this year. I am also happy to reiterate our commitment to
conclude our 800 million Swiss Franc share buy-back program within the
time-frame originally envisaged."
At Full Year 2012 reporting, unforeseen events excluded, Actelion guided for
flat local currency core earnings for 2013, single-digit core earnings growth
in 2014 and double-digit growth by 2015.
PRODUCT SALES FOR Q1 2013
In CHF million Results Results % Variance % Variance
Q1 2013 Q1 2012 In CHF In LC
Tracleer sales 375.0 363.7 3 4
Ventavis sales 27.4 27.7 (1) (1)
Veletri sales 6.7 5.3 25 24
Zavesca sales 22.9 18.6 23 23
Total Product Sales 432.8 415.8 4 5
PRODUCT SALES REVIEW
First quarter 2013 sales of Tracleer^® (bosentan) amounted to CHF 375.0
million compared to CHF363.7 million for the same period in 2012. This
represents an increase of 4% in local currencies. This performance was mainly
driven by a 7% increase in units shipped, impacted by some phasing of
wholesaler orders and positive pricing in the US.
Veletri^® (epoprostenol for injection) sales in the US in the first quarter of
2013 amounted to CHF 6.7 million, an increase of 24% compared to the same
period in 2012, which represents approximately a 50% share of epoprostenol
patients in the US. During the quarter, Veletri received regulatory approval
in Japan under the trade name Epoprostenol "ACT". In the European Union, the
decentralized procedure has reached a successful conclusion, first national
approval expected imminently.
During the first quarter 2013, Ventavis^® (iloprost) had sales in the US of
CHF 27.4 million compared to CHF 27.7 million in the first quarter 2012. In
local currencies, this represents a decrease of 1% - Ventavis continues to be
impacted by competitive pressure while benefiting from positive price
Sales of Zavesca^® (miglustat), for the first quarter of 2013, amounted to CHF
22.9 million compared to CHF 18.6 million during the same period last year.
This represents an increase of 23% in local currencies, driven predominantly
by strong ex-US patient demand in the Niemann-Pick Type C indication and
positive price movement in the US.
OPERATING EXPENSES REVIEW
Total operating expenses for the first quarter 2013 were CHF 309.2 million
compared to CHF 350.3 million for the first quarter of 2012, a decrease of
In Q1 2013, the company incurred a CHF 12.9 million charge from a concluded
arbitration proceeding. Other minor disputes are still pending. Given the
non-recurrent character of this charge, it has not been included in the
calculation of core earnings.
Research and Development (R&D) expenses in the first quarter of 2013 were down
29% to CHF 92.4 million (Q1 2012: CHF 129.9 million). R&D expenses are
expected to increase later in the year, in line with the initiation of two
Phase III programs.
Non-GAAP R&D expenses for the same period, which exclude stock-based
compensation expense and amortization and depreciation, were down 24% in local
currencies at CHF80.4 million compared to CHF 106.7 million in the first
quarter 2012 (Q1 2012 also excludes a payment made to Auxilium
Selling, General and Administrative expenses (SG&A) for the first quarter of
2013 were CHF 145.6 million (Q1 2012: CHF 161.9 million), representing a
decrease of 10%. SG&A expenses are expected to increase later in the year, in
line with the market introduction of macitentan (Opsumit), currently under
regulatory review in the United States, the European Union as well as in
Canada and Switzerland.
Non-GAAP SG&A expenses for the first quarter of 2013, which excludes
stock-based compensation expense, amortization and depreciation and impact of
doubtful debt provisions, were CHF 134.8 million compared to CHF 142.7 million
in the first quarter 2012, a decrease of 4% on a local currency basis.
OPERATING INCOME, CORE EARNINGS AND NET INCOME
Operating income for the first quarter 2013 was CHF 124.0 million compared to
CHF 67.1 million for the same period in 2012, an increase of 85%. In local
currencies operating income increased by 86%.
Financial expense amounted to CHF 9.0 million compared to CHF 13.5 million in
the first quarter of 2012. Main expense contributors were the interest on the
litigation provision (CHF 9.8 million) and the interest expense on the bond
(CHF 3.0 million).
Tax expense amounted to CHF 17.0 million, which translates into a tax rate for
the quarter of 14.8%.
Core earnings for the first quarter of 2013 amounted to CHF 168.5 million
compared to CHF 117.6 million during same period in 2012. This represents an
increase of 44% in local currencies.
Net income for the first quarter 2013 amounted to CHF 97.9 million (Q1 2012:
CHF45.1million). This represents an increase of 117% in Swiss Franc terms or
119% in local currencies.
US GAAP earnings per share on a fully diluted basis in the first quarter 2013
increased to CHF 0.85 from CHF 0.38 in the same period last year, whilst core
earnings per share increased by 57% to CHF 1.26.
During the first quarter of 2013, the company sold 1.9 million treasury shares
to a major US-based healthcare investor, resulting in a cash inflow of
approximately CHF 97 million. The company remains fully committed to share
dilution management and aims to finish the current share buy-back during the
fourth quarter of 2013.
NON-GAAP TO US GAAP RECONCILIATION FOR Q1 2013
In CHF million Q1 2013 Q1 2012
Product sales 432.8 415.8
Core operating expenses 264.3 298.2
Core earnings excluding impact of DDP 168.5 117.6
Movement in doubtful debt provision 0.1 -10.1
Contract revenues 0.4 1.6
Stock option expenses -13.6 -12.6
Amortization and depreciation -18.6 -20.4
Arbitration settlement -12.9 -
Auxilium milestone payment - -9.1
US GAAP Operating Income 124.0 67.1
CORE EPS CALCULATION
In CHF million Q1 2013 Q1 2012
Core earnings 168.5 117.6
Non-GAAP financial result 0.8 -4.1
Adjusted income before tax 169.3 113.5
Tax -25.1 -18.2
Adjusted net income 144.2 95.4
N^o of shares in calculation 114.9 118.9
Core EPS 1.26 0.80
oAnnual General meeting - 18 April 2013
oHY Financial Results 2013 reporting - 18 July 2013
o9M Financial Results 2013 reporting - 17 October 2013
oFY Financial Results 2013 reporting - 13 February 2014
oMacitentan regulatory decisions
oSelexipag complete enrollment
oSelexipag interim analysis for efficacy & futility
oInitiation of psoriasis Phase III
oInitiation of cadazolid Phase III
oCompletion of the current CHF 800 million share repurchase
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
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 2,400 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
For further information please contact:
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
Conference Call Information
Actelion Ltd will announce the first quarter 2013 financial results on
Tuesday, 16 April 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
16 April 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 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
The archived Investor Webcast will be available for replay through
http://www.actelion.com approximately 60 minutes after the call has ended.
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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland
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