ALLSCHWIL/BASEL, SWITZERLAND - 14 February 2013 - Actelion Ltd (SIX: ATLN) today announced financial results for the full year 2012.
- Positive results for macitentan (Opsumit®) reported in April - regulatory dossier submitted to FDA and EMA in Q4 2012
- Strategy for long-term shareholder value creation announced in May 2012
- Solid Tracleer® sales in a challenging environment, up 1% in volume (down 4% in local currencies)
- Regulatory approvals for improved formulation of Veletri® in US, Switzerland and Canada
- Ponesimod in psoriasis and cadazolid in Clostridium difficile associated diarrhea to move into Phase III during 2013 following successful mid-stage study results
- Product sales of CHF 1,722.1 million, down 2% in local currencies
- Core earnings of CHF 537.0 million, up 6% in local currencies
- Core EPS of CHF 3.69, up 16% in local currencies
- Strong earnings and cash generation enables a proposed 25% increase in dividend to CHF 1.00 per share
- CHF 800 million share repurchase program to be completed (remaining CHF 416 million) in 2013
- 2013 Guidance: Maintain local currency core earnings at 2012 level
| In CHF Million|
(except for per share data)
| Results |
| % Variance|
| % Variance|
|US GAAP Operating income||421.5||12.2||*||*|
|Core earnings (excluding DDP)||537.0||480.6||12||6|
|US GAAP EPS (fully diluted)||2.57||(1.23)||-||-|
|Core EPS (fully diluted)||3.69||3.04||22||16|
As of 31 December 2012, Actelion had cash and cash deposits of CHF 1.5 billion (of which CHF 368.7 million is restricted). In addition, Actelion holds 13.8 million treasury shares.
Jean-Paul Clozel, MD, Chief Executive Officer commented: "2012 was a landmark year for Actelion. Through the successful trial with macitentan (Opsumit®) announced in April, we have demonstrated our ability to innovate at Actelion. With organizational discipline and a strong commitment to quality, our clear objective ahead is to translate that innovation into benefits for patients and long-term value for shareholders. Actelion is now at a very exciting stage in its development."
Andrew Oakley, Chief Financial Officer added: "In 2012, we have achieved the appropriate balance between attractive shareholder returns, investment in the business and a strong capital structure. We have delivered significant returns to shareholders through the continuation of the buyback program and we are proposing a 25 percent increase in dividend. At the same time we continue with the right level of investment in R&D. Actelion therefore remains on track to deliver on the short- to mid-term core earnings guidance announced at the time of our strategic review."
For 2013, Actelion expects to maintain local currency core earnings at the 2012 level, barring unforeseen events. The company then expects to return to single-digit core earnings growth in 2014 and double-digit growth by 2015.
Full details on the progress made in 2012 are available in Actelion's 2012 Annual Report, available from www.actelion.com
PRODUCT SALES FOR FY2012
| In CHF million|| Results|
| Results |
| % Variance|
| % Variance|
|Total Product Sales||1,722.1||1,713.0||1||(2)|
2012 was a demanding year for Actelion's products on the market. It was challenging due to a number of factors beyond the company's control, including the very difficult pricing environment outside the US and the continued strength of the Swiss Franc - Actelion's reporting currency. Furthermore, in the US, the company's pulmonary arterial hypertension (PAH) product portfolio continues to face significant competition, although here the effects have been mitigated by price increases across our portfolio.
Despite the difficult market environment, total product sales of CHF 1,722.1 million were achieved. This is marginally lower (2% in local currencies) than last year's total, reflecting, in particular, the negative pricing environment in territories outside the US, where revenues declined in spite of solid mid- to high-single-digit volume growth.
In 2012, the company encountered the first launches of generic versions of bosentan in Canada. Actelion's dedication to the PAH community has been rewarded with loyalty, and hence generic erosion of sales of Tracleer® has been slower than benchmarks would suggest.
The global sales breakdown is consistent with 2011. Japan and emerging PAH markets such as Mexico, Russia and China continued to deliver very solid local-currency sales growth. Overall, 41% of sales came from US operations, 37% from Europe, 12% from Japan and 10% from the rest of the world.
NON-GAAP TO US GAAP RECONCILIATION FOR FY2012
|In CHF million||FY2012||FY 2011|
|Core operating expenses||(1,185.1)||(1,232.4)|
|Core earnings excluding impact of DDP||537.0||480.6|
|Movement in doubtful debt provision||22.6||(43.2)|
|Stock option expenses||(46.6)||(84.9)|
|Amortization and depreciation||(81.9)||(82.9)|
|Auxilium milestone payment||(9.1)||-|
|US GAAP Operating Income||421.5||12.2|
CORE EPS CALCULATION
|In CHF million||FY2012||FY 2011|
|Non-GAAP financial result||(21.4)||(44.4)|
|Adjusted income before tax||515.7||436.2|
|Adjusted net income||436.2||360.7|
|No of shares in calculation||118.1||118.8|
NOTES TO SHAREHOLDERS:
The Annual General Meeting of Shareholders to approve the Business Report of the year ending 31 December 2012 will be held on 18 April 2013.
Shareholders holding more than CHF 1,000,000 nominal value of shares (i.e. 2,000,000 shares at nominal value of CHF 0.50), being entitled to add items to the agenda of the general meeting of shareholders, are invited to send in proposals, if any, to Actelion Ltd, attention Corporate Secretary, Gewerbestrasse 16, CH-4123 Allschwil, to arrive no later than 8 March 2013. Any proposal received after the deadline will be disregarded.
In order to attend and vote at the Annual General Meeting of Shareholders, shareholders must be registered in the Company's shareholder register by 9 April 2013 at the latest.
- Q1 Financial Results 2013 reporting on 16 April 2013
- Annual General Meeting of Shareholders on 18 April 2013
- HY Financial Results 2013 reporting on 19 July 2013
NOTES TO EDITORS
CHAIRMAN AND CHIEF EXECUTIVE STATEMENT
CREATING VALUE THROUGH SCIENTIFIC INNOVATION
2012 was a landmark year for Actelion. In April, we announced positive results for macitentan (Opsumit®), the latest addition to our pulmonary arterial hypertension (PAH) portfolio. Macitentan - the result of a tailored, in-house drug discovery process - was evaluated in the largest morbidity/mortality study ever conducted in PAH. This long-term outcome study, SERAPHIN, which began in 2007 and lasted over four years, demonstrated that macitentan provides a significant and clinically relevant reduction in the risk of morbidity/mortality. This novel and differentiated dual endothelin receptor antagonist (ERA) is an excellent example of how value in the pharmaceutical industry is best created through innovation.
Following the announcement of the results of the SERAPHIN study, the management and Board took immediate steps to shape the future direction of your company. In May, we announced our strategy for long-term shareholder value creation, built around three key elements. We are focusing our efforts on sustaining and growing our PAH franchise in the short-term and on building a second specialty franchise as a mid-term goal. These two elements will allow us to deliver on the third element of our strategy - increasing profitability. By the end of 2012 rapid progress had already been made with its implementation.
SUSTAINING GLOBAL LEADERSHIP IN PAH THERAPY
Actelion is sustaining its leadership in the PAH market with its broad range of products. In 2012, Tracleer® continued to be the ERA of choice for prescribing physicians, even in regions with strong competition. Our strategy of treating PAH with the aim of improving symptoms to, or maintaining patients at, Functional Class II enabled Tracleer to remain the gold standard in PAH treatment, with over 44,000 PAH patients currently receiving therapy. Ventavis®, which is formulated for optimized inhalation time, continued to be an important source of revenue for our US operations.
Veletri® is an improved formulation of intravenous epoprostenol. Unlike other epoprostenol formulations approved for PAH, Veletri has greater stability. This provides unique benefits, such as a more flexible preparation of the medication and infusion of the product without the need for constant cooling with ice-packs. During 2012, Actelion received approval to market a further improved formulation of Veletri in the US, Switzerland and Canada, with regulatory reviews advancing in Japan and the EU. Access to these additional markets will bring further opportunity for growth.
This leading position in the PAH market is now set to continue thanks to our pipeline compounds. Following the positive study results, the registration dossier for macitentan was submitted to the US Food & Drug Administration (FDA), the European Medicines Agency (EMA) and other health authorities during the fourth quarter of 2012. With the combination of an effective worldwide commercial organization and this novel and differentiated ERA, Actelion will enable the medical community to reshape the treatment paradigm for patients with PAH.
In parallel, Actelion has advanced selexipag, potentially the first oral prostacyclin-based therapy for the treatment of PAH, which is currently in Phase III. At the end of 2012, we had enrolled more than 1,000 patients into the pivotal study. As with our evaluation of macitentan, this outcome study is designed to demonstrate a reduction in the risk of morbidity/mortality events.
BUILDING AN ADDITIONAL SPECIALTY FRANCHISE
The second part of our strategy for long-term value creation is to build an additional specialty franchise alongside PAH. We have focused our research and development (R&D) efforts on orphan and specialty indications, supported by ongoing business development activities; the aim is to utilize our expertise to find differentiated commercial assets that a company of our size can successfully bring to market.
Choosing to concentrate our efforts on orphan and specialty indications will lead to more targeted R&D spending. Following a portfolio review, those projects not aligned with this strategy have been discontinued or are being prepared for partnership or out-licensing.
At the end of 2012, excellent progress was reported for two of Actelion's mid-stage clinical studies. First we announced positive results with ponesimod, an S1P1 modulator, in psoriasis, a chronic and relapsing skin disease affecting up to 3% of the population worldwide. The findings were particularly encouraging since this is the first time that this mode of action has been effective for psoriasis patients. This news was shortly followed by the positive results for our novel antibiotic, cadazolid, in Clostridium difficile associated diarrhea (CDAD). The bacterium Clostridium difficile is the leading cause of hospital acquired diarrhea and CDAD can be severe, even life-threatening. This is the first time cadazolid has been used to treat patients and has delivered very encouraging clinical data. Based on the excellent progress, Actelion has decided to proceed with the development of both compounds in Phase III, providing the foundation for our mid-term goal of building an additional specialty franchise.
MAINTAINING AND GROWING PROFITABILITY
In 2012, Actelion delivered core earnings of CHF 537.0 million, an increase of 12% in Swiss Francs or 6% in local currencies (excluding the impact of provisions for doubtful debts). This result - achieved in spite of a challenging economic environment - is a direct consequence of our cost-saving initiative and underscores our commitment to optimize the company's profitability.
The cost-saving initiative implemented in the second half of 2012 addressed several ongoing external challenges, including the continued strength of the Swiss Franc, increased competition in the US, and the difficult pricing environment in Europe. In parallel, we adapted the size of our R&D organization to match our new focus on specialty medicines. Importantly, this initiative left our commercial capabilities unchanged and will ensure the availability of sufficient investment capacity to leverage the opportunities we have created in the field of PAH.
We strongly believe that, thanks to the measures implemented in 2012, your company is well positioned for sustainable core earnings growth and enhanced shareholder returns. For 2013, we expect to maintain local currency core earnings at the 2012 level, barring unforeseen events. We then expect single-digit core earnings growth in 2014 and double-digit growth by 2015.
Our commitment goes beyond performance forecasts: Actelion's balance sheet, strong cash generation and the exceptional pipeline newsflow in 2012 gives us confidence in our future. Therefore the Board will propose a 25% increase in the dividend payment for your approval at the 2013 Annual General Meeting. In addition, we will manage capital allocation so as to continue to return value to our shareholders through timely completion of the CHF 800 million share repurchase program by the end of 2013.
COMMITMENT TO GROWTH
Since the company was established some fifteen years ago, Actelion has been committed to discovering innovative drugs that change the lives of patients. We have demonstrated the benefits of those drugs through innovative clinical development, laying the foundations for evidence-based medicine. We have also made our drugs for specialty indications available worldwide.
We are confident in our ability to innovate, and we believe that, through organizational discipline and a commitment to quality, innovation can be translated into benefits for patients and long-term value creation for shareholders. This is an exciting time for the company, and we hope you will share our enthusiasm as you read about what we have achieved in 2012 and our plans for the future.
Jean-Pierre Garnier Jean-Paul Clozel
Chairman of the Board of Directors Chief Executive Officer
The European debt crisis and slower global economic growth continued to impact the business landscape in 2012. Pressure on government budgets weighed heavily on healthcare markets around the globe. Additionally, the competitive environment continued to adversely affect sales in the United States. Amid these challenges Actelion posted a solid top line performance with benefits from cost reductions seeing core earnings growing by 6% in local currencies, thereby delivering significant operational leverage.
Actelion's commercial organization delivered a strong sales performance in 2012, despite intensified price pressure and continued competition. Total product sales for the full year were CHF 1,722.1 million. This represents an increase of 1% in Swiss Francs and a decrease of 2% in local currencies.
Contract revenues for 2012 amounted to CHF 6.3 million. In 2011, contract revenues included the remaining deferred revenue from the terminated orexin collaboration with GlaxoSmithKline.
Actelion is focusing its resources on commercial efforts and pipeline programs that have the greatest potential to deliver meaningful benefits for patients. For 2012, total operating expenses were CHF 1,306.9 million compared to CHF 1,783.9 million during 2011. The main driver of the decrease is the impact in 2011 of the Asahi Kasei litigation award of CHF 340.6 million as well as a reduction in provisions made for doubtful debts in southern Europe, mainly as a result of improved cash collection. Expenses in 2012 also included a restructuring charge of CHF 6.9 million related to the cost saving initiative executed during the second half of the year.
Cost of sales amounted to CHF 196.3 million, or 11% of sales, unchanged from the previous reporting period.
Research and development (R&D) expenses increased by 1%, to CHF 460.5 million, compared to CHF 457.7 million in 2011. These expenses include the USD 10 million milestone payment to Auxilium Pharmaceuticals, Inc. in relation to our collaboration on XIAFLEX® in certain territories. The lower R&D expenditure net of the Auxilium payment is the result of the refocusing of Actelion's pipeline, announced as part of the company's strategic review in May 2012, which is expected to continue to reduce R&D expenditure in the coming year.
Selling, general and administration (SG&A) expenses for 2012 amounted to CHF 610.9 million, a decrease of 19% in Swiss Francs and 20% in local currencies. Part of this decrease can be attributed to the reduction in the allowance for doubtful debt on receivables in southern Europe.
Core operating expenses (includes cost of sales) for the full year were CHF 1,185. 1 million, a decrease of 5% in local currencies compared to the previous year. Core operating expenses exclude all charges related to employee stock options; depreciation and amortization; and one-off items that distort comparative analysis, such as the legal provision of CHF 340.6 million or the restructuring charge of CHF 6.9 million and provisions for doubtful debts. Core R&D expenses amounted to CHF 398.5 million, down 1% compared to the previous year in local currencies while core SG&A expenses decreased by 9% to CHF 590.2 million, also in local currencies.
The result of all of the above is a reported operating income of CHF 421.5 million for 2012, compared with CHF 12.2 million in 2011.
Better reflecting the actual operating performance of the business is the core earnings measure amounting to CHF 537.0 million, an increase of 6% in local currency terms which represents an 8% improvement in operating margin. Core earnings exclude movements in doubtful debt provisions and other one-time items such as the Asahi litigation provision in 2011.
NON-OPERATING RESULTS AND TAXES
Interest income for 2012 amounted to CHF 2.1 million compared to CHF 6.2 million in 2011.
The interest provision on the Asahi litigation award, which accrues at an annual rate of 10% and is payable only if the appeal is not successful, amounted to CHF 41.6 million for 2012, compared to CHF 19.7 million during 2011. Interest expense (including issuance costs) on the CHF 235 million bond was CHF 12.0 million, impairment on financial assets amounted to CHF 0.3 million and other interest expense, relating mostly to deferred consideration in connection with the acquisition of a new formulation of epoprostenol sodium with improved thermal stability from GeneraMedix, amounted to CHF 0.5 million.
Other financial expenses for the year amounted to CHF 10.6 million, compared to CHF 22.9 million in 2011.
Income tax expense for the period under review amounted to CHF 55.2 million, compared with CHF 77.0 million in 2011. The tax rate for the year is 15.4% compared to a litigation provision adjusted tax rate of 17.3% for the previous year.
NET INCOME AND EARNINGS PER SHARE
Net income for the full year of 2012 amounted to CHF 303.2 million compared to a loss of CHF 146.3 million in 2011.
This translates into fully diluted earnings per share of CHF 2.57. Core earnings per share were CHF 3.69, an increase of 22%.
BALANCE SHEET AND CASH FLOW
Our cash generation remains strong, enabling us to invest for future growth and value by funding investment in R&D, while also providing CHF 357.9 million in net cash distributions to shareholders by way of dividends and share repurchases.
Cash from operations for the period under review amounted to CHF 572.4 million, compared with CHF 404.9 million in 2011. The company's gross cash position at 31 December 2012 amounted to CHF 1.5 billion, of which CHF 368.7 million is restricted due to the ongoing Asahi litigation in the California courts.
Despite continuing difficult economic conditions in southern Europe, trade and other receivables decreased from CHF 536.5 million at the end of December 2011 to CHF 412.9 million at the end of the year. Days sales outstanding (DSO) decreased from 103 days to 78 days.
During the first quarter of 2012, Actelion Spain enrolled in the Montorro plan, which is designed to inject cash into the Spanish economy through settlement of local authorities' commercial debt. Through this arrangement, late in the second quarter, we collected over CHF 100 million from government customers in Spain resulting in a partial reversal of doubtful debt provisions. For the full year 2012, the total reduction in doubtful debt provisions was CHF 22.6 million, compared to an increase in the provision of CHF 43.2 million in 2011.
Investment in property, plant and equipment decreased to CHF 33.7 million in 2012, compared with CHF 89.4 million in 2011. The majority of this investment relates to the construction of a research and development building. Total property, plant and equipment at year-end was CHF 402.6 million, compared to CHF 424.7 million at the end of 2011.
Total shareholders' funds amounted to CHF 1,518.6 million at the end of 2012 compared to CHF 1,510.5 million at the end of 2011.
Retaining an appropriate balance between attractive shareholder returns, investment in the business and a strong capital structure will remain a priority in the future. Actelion's Board proposes to increase the dividend payment to CHF 1.00 from CHF 0.80 per share and will ask for shareholder approval to do so at the upcoming Annual General Meeting on 18 April 2013.
During 2012, the company bought back 6.4 million shares at a total cost of CHF 264.2 million on the second trading line as part of the CHF 800 million share repurchase program announced in October 2010. This brings the number of treasury shares held to 13.8 million, or 11% of the total issued share capital. The Board is committed to completing the current repurchase program by the fourth quarter of 2013.
INTERNAL CONTROL OVER FINANCIAL REPORTING
Actelion is committed to maintaining strict oversight of its financial reporting. In keeping with that commitment, for the seventh consecutive year, the internal controls over financial reporting were certified as meeting the requirements of SOX 404 (Sarbanes-Oxley Act 2002, section 404) at 31 December 2012.
CLINICAL DEVELOPMENT UPDATE
Actelion currently has 10 compounds in clinical development studied in several therapeutic areas. The company is currently pursuing Phase III programs with two different compounds with an additional two compounds in preparation for Phase III investigation.
Actelion's clinical development pipeline:
|Phase||Product/ Compound||Indication||Study||Results expected|
|IV||Bosentan||Combination bosentan & sildenafil in PAH||COMPASS-2||2013|
|IV||Bosentan||Pediatric pulmonary arterial hypertension||FUTURE||2014|
|III||Macitentan||Pulmonary arterial hypertension||SERAPHIN||Complete|
|III||Selexipag||Pulmonary arterial hypertension||GRIPHON||2014|
|III||Macitentan||Digital ulcers related to systemic sclerosis||-||2014|
|II||Cadazolid||Clostridium difficile associated diarrhea||-||Complete|
|I||CRTH2 receptor antagonist||Asthma||-||-|
|I||Lucerastat||Lipid storage disorders||-||-|
|I||S1P1 modulator||Immunological disorders||-||-|
For more information visit the corporate website:
At the end of 2012, Actelion employed 2,433 professionals worldwide, a decrease of 5% (or 137 positions) compared to the end of 2011.
ASAHI KASEI PHARMA CORPORATION AGAINST ACTELION LTD
In 2008, a lawsuit was filed by Asahi Kasei Pharma Corporation against Actelion Ltd, certain subsidiaries and three individual officers in a Californian Superior Court. The action arises from a dispute involving the license and development agreement between Asahi and CoTherix for the drug compound fasudil that has been terminated upon the acquisition of CoTherix in 2007.
During 2011, the case was heard in trial court and resulted in a jury award of compensatory and punitive damages. Following post-trial motions the trial court entered a final judgment of USD 407.3 million and additional prejudgment interest and costs of USD 8.3 million, in November 2011. The company and its external advisors believe that the jury verdict and trial court judgment are neither supported by the facts nor correct as a matter of law. The company strongly believes that there are significant grounds for a successful appeal, notice of which was filed with the California Courts of Appeal in December 2011. The appeal is proceeding as expected.
UNITED STATES ATTORNEY'S OFFICE FOR THE NORTHERN DISTRICT OF CALIFORNIA
In 2010, the company reported that its wholly owned US subsidiary Actelion Pharmaceuticals US, Inc. had received a subpoena from the United States Attorney's Office for the Northern District of California, requesting documents relating, among others, to marketing and sales practices of Tracleer in the US. The corresponding investigation is ongoing.
DEVELOPMENT OF COMPETING GENERIC PRODUCTS
During 2011 and 2012, three generic companies, Apotex Inc., Roxane Laboratories, Inc. and Actavis Elizabeth, LLC demanded that Actelion provided them samples of Tracleer and Zavesca for the purpose of developing competing generic products. On September 14, 2012, Actelion filed a lawsuit against the generic companies in the United States District Court for the District of New Jersey seeking a declaratory judgment that Actelion has no legal duty or obligation to sell any quantity of the drugs to generic competitors. In response, the generic companies are alleging that Actelion violated federal and state antitrust laws. Actelion has filed a motion requesting the Court find in the company's favor based on the pleadings.
The Group is involved in commercial disputes in certain jurisdictions. The possible losses which might arise as a result of the corresponding arbitration proceedings range from CHF 0 million to CHF 18 million. At this time the company cannot reasonably estimate the final outcome. The company expects a resolution of these proceedings during 2013.
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:
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