Product sales of CHF 415.8 million, down 4% in local currencies - 2012 Product sales guidance upgraded to low single digit decrease - Core Earnings of CHF 107.6 million, down 9 % in local currencies - 2012 Flat Core Earnings Guidance reiterated - Macitentan results in morbidity/mortality PAH study expected in the next few weeks
ALLSCHWIL/BASEL, SWITZERLAND - 19 April 2012 - Actelion Ltd (SIX: ATLN) today announced its financial results for the first quarter 2012.
| In CHF Million|
(except for per share data)
| Results |
| % Variance|
| % Variance|
|Total net revenues||417.5||528.2||(21%)||(18%)|
|US GAAP EBIT||67.1||164.7||(59%)||(54%)|
|US GAAP EPS (fully diluted)||0.38||1.20||(68%)||(63%)|
As of 31 March 2012, Actelion had cash and cash equivalents of CHF 1.3 billion (includes restricted cash of CHF 365 million). In addition, Actelion holds 13.9 million treasury shares.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "As expected, the market place remains very challenging, mostly due to changes in the competitive landscape in the United States and strong pricing pressures in certain markets. In that context, our product sales performance is acceptable.
Jean-Paul Clozel continued: "In this difficult environment, Actelion maintained its strong global leadership in the endothelin receptor antagonist market. We hope to build on this position of strength with SERAPHIN, a morbidity/mortality study evaluating our second-generation endothelin receptor antagonist, macitentan. I expect study results to become available in the next few weeks."
Andrew J. Oakley, Chief Financial Officer of Actelion commented: "In the first quarter of 2012, Actelion's overall performance reflects the dynamics of the market place, including the continued strength of the Swiss Franc."
Initially, Actelion expected 2012 product sales (in local currencies) to decrease in the low-to mid-single digit range. In the first quarter 2012, while overall pricing pressure has remained very high, the US pricing environment improved slightly during the first quarter. Moving forward, Tracleer® pricing in Japan was left unchanged by the Japanese authorities.
Andrew Oakley continued: "Unforeseen events excluded, Actelion can now provide an improved product sales forecast. The decrease in local currencies is now expected to be in the low-single digit range. Actelion remains on track to meet its previously issued guidance of flat 2012 core earnings."
Product sales for the first quarter of 2012 were CHF 415.8 million (Q1 2011 CHF 450.1 million), a decrease of 4 % in local currencies with 37 % of sales coming from the United States, 41 % from Europe, 11 % from Japan and 11 % from the rest of the world.
First quarter 2012 sales of Tracleer (bosentan) amounted to CHF 363.7 million compared to CHF 402.8 million for the same period in 2011. This represents a decrease of 6 % in local currencies and a decrease of 1% in units shipped.
During the first quarter 2012, Ventavis® (iloprost) had sales in the United States of CHF 27.7 million compared to CHF 28.0 million in the first quarter 2011. In local currencies, this represents an increase of 1 %, with unit decline compensated by price.
Sales of Zavesca® (miglustat), for the first quarter of 2012 amounted to CHF 18.6 million compared to CHF 16.5 million during the same period last year. This represents an increase of 19 % in local currencies driven predominantly by strong patient demand in Niemann Pick Type-C indication (outside the US) as well as a positive US pricing impact.
Actelion's fourth product in the US is Veletri® (epoprostenol for injection), a parenteral prostacyclin formulation providing the efficacy of epoprostenol with an increased stability at room temperature. Sales of this product for the first quarter of 2012 amounted to CHF 5.3 million. Registration in Japan and Europe with the second generation formulation is ongoing.
Contract revenues for the first quarter of 2012 amounted to CHF 1.6 million. Contract revenues for the first quarter of 2011 amounted to CHF 78.1 million, with the majority of this amount (CHF 76.5 million) stemming from the final recognition of the remaining deferred revenue from the ongoing orexin collaboration with GlaxoSmithKline.
Total operating expenses for the first quarter 2012 were CHF 350.3 million compared to CHF 363.6 million for the first quarter of 2011, a decrease of 4 %.
Research and Development (R&D) expenses in the first quarter of 2012 were up 8 % to CHF 129.9 million (Q1 2011: CHF 120.7 million). This increase was entirely driven by a USD 10 million milestone payment to Auxilium Pharmaceuticals, related to the collaboration the two companies announced in February 2012 for XIAFLEX in Canada, Australia, Brazil and Mexico.
Non-GAAP R&D expenses for the same period, which excludes stock-based compensation expense, amortization and depreciation as well as the payment to Auxilium, were basically flat at CHF 105.4 million compared to CHF 105.8 million in the first quarter 2011.
Selling, General and Administrative expenses (SG&A) for the first quarter of 2012 were CHF 161.9 million (Q1 2011: CHF 181.4 million), representing a decrease of 11 %.
Non-GAAP SG&A expenses for the first quarter of 2012, which excludes stock-based compensation expense, amortization and depreciation, were CHF 154.1 million compared to CHF 165.1 million in the first quarter 2011, a decrease of 4 % on a local currency basis or 12 % excluding the effect of doubtful debt provisions in both comparative periods.
Operating income for the first quarter 2012 was CHF 67.1 million compared to CHF 164.7 million for the same period in 2011, a decrease of 59%. In local currencies operating income decreased by 54 %.
In order to better compare the company's underlying performance, Actelion reports core earnings as product sales minus cash operating expenses, as well as other items that may distort comparison.
For the first quarter of 2012, core earnings amounted to CHF 107.6 million compared to CHF 127.9 million during the first quarter of 2011. This represents a decrease of 9 % in local currencies.
Net income for the first quarter 2012 amounted to CHF 45.1 million (Q1 2011: CHF 146.3 million). This represents a decrease of 69 % in Swiss Franc terms or 64 % in local currencies.
Net income for the period includes interest income of CHF 0.5 million, interest expense of CHF 0.4 million, interest expense on the litigation provision of CHF 9.4 million, interest expense on the Swiss Franc bond of CHF 3.0 million, impairment of financial assets of CHF 0.3 million related to Greek bonds, and other financial expense of CHF 0.9 million related to hedging and valuation gains and losses.
Income tax expense for the first quarter amounts to CHF 8.6 million which translates into a tax rate of 16 %.
US GAAP earnings per share on a fully diluted basis in the first quarter 2012 decreased by 68 % compared to the same period a year ago to CHF 0.38 whilst Core earnings per share decreased by 31 % to CHF 0.66.
Clinical Development update
Actelion provided a full clinical pipeline update in the Annual Report, published 14 February 2012. Since then, the company has made the following changes:
Actelion is re-directing its development efforts in the anti-inflammatory area, focusing on a potent follow-up CRTH2 antagonist currently in Phase I clinical development. Two recently concluded studies with the first orally-active CRTH2 antagonist, setipiprant, in asthma (Phase IIb) and seasonal allergic rhinitis (Phase III profiling) did not confirm efficacy findings made in earlier studies. Accordingly, clinical development with this well-tolerated agent in these indications is being discontinued.
In Q1 2012, Actelion also concluded the evaluation of a cardiovascular compound in a proof-of-concept study in essential hypertension. The desired target profile was not achieved. Development of this compound in such cardiovascular indications as essential hypertension or stable angina will not be further pursued.
NOTE TO THE SHAREHOLDERS:
The Annual General Meeting of Shareholders to approve the Business Report of the year ending 31 December 2011 will be held on 4 May 2012.
In order to attend and vote at the Annual General Meeting of Shareholders, shareholders must be registered in the Company's shareholders register by 25 April 2012 at the latest. For information on how to register shares, please visit the company's website at http://www.actelion.com/en/investors/first-time-investor/how-to-register-shares.page?
- Actelion Annual General Meeting - 4 May 2012
- H1 2012 financial results - 19 July 2012
- 9M 2012 financial results - 18 October 2012
For Documentation Purposes
Full Financial Statement:
The full financial statement for the first quarter of 2012 can be found as a PDF attached to the media release. It is also available on www.actelion.com in the Investor section
Non-GAAP to US GAAP reconciliation for Q1 2011
|In CHF Million||Q1 2012||Q1 2011|
|Stock option expenses||(12.6)||(20.4)|
|Amortization and depreciation||(20.4)||(20.9)|
|Auxilium milestone payment||(9.1)||-|
|US GAAP EBIT||67.1||164.7|
Notes to the editor:
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. Actelion, founded in late 1997, 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 2,500 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:
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 2012 financial results on Thursday, 19 April 2012, at 07.00 hrs CEST / 06.00 hrs BST / 01.00 a.m. EST. An investor conference call & webcast will be held at 14.00 hrs, CEST to discuss the results.
|19 April 2012||14.00 hrs||Basel (CEST)|
|13.00 hrs||UK (BST)|
|08.00 a.m||US (EST)|
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 53
US: +1 866 907 59 23
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.
The archived Investor Webcast will be available for replay through http://www.actelion.com
approximately 60 minutes after the call has ended.