Actelion Pharmaceuticals Ltd : Actelion delivers strong first quarter 2013 results

  Actelion Pharmaceuticals Ltd : Actelion delivers strong first quarter 2013
                                   results

Actelion Pharmaceuticals Ltd / Actelion delivers strong first quarter 2013
results . Processed and transmitted by Thomson Reuters ONE. The issuer is
solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 16 April  2013- Actelion Ltd (SIX: ATLN)  today 
announced financial results for the first quarter of 2013.



OPERATING HIGHLIGHTS

  *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
    expected imminently
    
  *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
    in CDAD



FINANCIAL HIGHLIGHTS

  *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
    currencies
    
  *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
    year-end

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 
movement.

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 
12%.

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 
Pharmaceuticals, Inc.).

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



UPCOMING EVENTS

  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 
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 2,400  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 
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 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
the results.



Date/Time:

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 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
Financial Statement
Financial Fact Sheet
Webcast

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Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;
 
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