Actelion Pharmaceuticals Ltd / Actelion delivers outstanding 2014 results . Processed and transmitted by NASDAQ OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.

ALLSCHWIL/BASEL, SWITZERLAND - 16 February 2015 - Actelion Ltd (SIX: ATLN) today announced its results for the full year 2014.


OPERATING HIGHLIGHTS

  • Opsumit - Sales of CHF 180 million reflect highly successful first year on the market
  • Selexipag (Uptravi) - positive morbidity/mortality Phase III pivotal study results
  • Selexipag (Uptravi) - Registration dossier submitted to US and European regulators
  • Tracleer - Continued strong demand in markets where Opsumit is not yet available
  • Tracleer - PIP Compliance Statement for Tracleer issued in Europe
  •  Veletri - Growing 84% (at CER) versus 2013 - becoming a global asset

FINANCIAL HIGHLIGHTS

  • Product sales of CHF 1,956 million, up 12% at CER (up 10% ex US rebate reversals)
  • Core earnings of CHF 743 million, up 25% at CER (up 20% ex US rebate reversals)
  • Core EPS of CHF 5.58, an increase of 33% at CER
  • Proposed increased dividend of CHF 1.30 on the back of strong cash generation
  • New second-line share buyback program - up to 10 million shares within 3 years, subject to approval by the relevant authorities
  • 2015 financial guidance - from 2014 base (excluding US rebate reversals) Low-single digit core earnings growth expected at CER
    % variance
in CHF millions
(except for per share data)
2014 2013  in CHF at CER(1)
Product sales 1,956 1,784 10 12
US GAAP Operating income 570 482 18 24
Core earnings (Core operating income) 743 619 20 25
US GAAP EPS (fully diluted) 5.11 3.92 30 37
Core EPS (fully diluted) 5.58 4.41 27 33

 

As of 31 December 2014, Actelion had cash and cash equivalents of CHF 1.2 billion. In addition, Actelion holds 3 million treasury shares.

(1) CER percentage changes are calculated by reconsolidating both the FY 2014 and FY 2013 results at constant currencies (the average monthly exchange rates for FY 2013)

Jean-Paul Clozel, MD, Chief Executive Officer, commented: "2014 was an outstanding year for Actelion, with successes on all fronts. We've delivered strong sales growth and saw a substantial uptake of the recently launched Opsumit. A particular highlight was the Phase III results for our novel PAH treatment selexipag (Uptravi), which we filed for regulatory review in both the US and EU at the end of 2014. We have also strengthened our innovation by advancing the pipeline and will share more details throughout 2015. Reflecting on the successes of 2014, as well as our promising pipeline, I am confident that we are well positioned for future success."

Jean-Paul Clozel added: "We have delivered on our commitment to create continued value to our shareholders with almost 1.1 billion Swiss francs being returned through a second-line share buyback program and dividend payments over the past three years. In addition, during 2014, the company purchased 5.7 million shares on the first-line of the Swiss Stock Exchange to mitigate dilution arising from employee stock compensation programs." Jean-Paul Clozel concluded: "Moving forward, and as part of our continued commitment to shareholder value creation, the Board will recommend that shareholders approve the payment of an increased dividend amounting to CHF 1.30 per registered share. In addition, the Board has authorized in principle, subject to approval by the relevant authorities, a new second-line share repurchase program of up to 10 million shares, within three years."

André C. Muller, Chief Financial Officer, commented: "The strong 2014 performance has set a high bar for 2015, a year where Tracleer, Ventavis and Zavesca will all be facing increased generic and pricing pressures. Despite the continued unfavorable foreign exchange environment, further compounded by the Swiss National Bank's decision to discontinue the 1.20 Swiss franc minimum exchange rate to the euro, we are confident that our long-term strategy coupled with tight financial oversight will result in continued shareholder value creation."

Barring unforeseen events and the benefit of US rebate reversal in 2014, Actelion forecasts 2015 core earnings growth, at constant exchange rates, to be in the low-single digit percentage range.

 

ANNUAL REPORT

Full details on the progress made in 2014 are available in Actelion's 2014 Annual Report, at www.actelion.com/annual-report:
http://www.actelion.com/annual-report.

 

NOTES TO SHAREHOLDERS:

The Annual General Meeting (AGM) of Shareholders to approve the Business Report of the year ending 31 December 2014 will be held on 8 May 2015.

At the AGM, the Board of Directors will recommend that shareholders approve a dividend of CHF 1.30 per share, an increase of 8%.

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 27 March 2015. 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 27 April 2015 at the latest.

 

UPCOMING EVENTS

  • March 15, 2015: Selexipag - first scientific presentation of GRIPHON data at American College of Cardiology (ACC.15), Actelion to host an investor relations evening event by invitation only
  • 3M 2015 Financial Results reporting on 21 April 2015
  • Annual General Meeting 2015 on 08 May 2015
  • HY 2015 Financial Results reporting on 21 July 2015

 

###

NOTES TO THE EDITOR

 

CHAIRMAN'S LETTER TO SHAREHOLDERS

Dear Shareholders,

2014 was an excellent year for Actelion and for the communities we serve. Once again, the company made significant commercial and clinical progress. Not only did we successfully launch Opsumit® (macitentan) in nearly 20 countries and submit the selexipag (Uptravi®) registration dossier to European and US regulators for marketing authorization, we also advanced our pipeline with potential therapies which we expect to shape our future. Reporting strong financial results and operating performance, we delivered substantial value to our shareholders. These achievements are the fruits of more than a decade of focused investments, validating the strategic decision to be a fully integrated company that discovers, develops and commercializes our products around the world. Building on this momentum, we are entering 2015 with great confidence in our ability to execute our long-term strategy and accomplish our mission to treat more patients with groundbreaking therapies.

BUSINESS PERFORMANCE

Our performance during 2014 reflects Actelion's leadership in the PAH market, effective commercial execution and commitment to operational efficiency, as well as the dedication of our people. Product sales increased by 12% to almost CHF 2 billion, while core earnings rose 25% to CHF 743 million, both at constant exchange rates. As a result, core earnings per share amounted to CHF 5.58.

The company's excellent performance and news flow in 2014 was reflected in the share price, as the top performer of the Swiss Market Index. At the end of December, Actelion's stock traded at CHF 115.30 per share, an increase of 53% for the calendar year. It is worth noting that, over the past three years, Actelion shares have appreciated by almost 250%. This year's share price performance, together with the increased dividend of CHF 1.20 per share, paid out in May, resulted in a total shareholder return (TSR) of 55% for 2014

STRATEGY

Our success - not just during the past year, but throughout our history - has been based on a clear strategy to ensure continued value creation. I am confident that all the necessary elements are in place to deliver on the next phase of value creation. We have the right infrastructure - a global commercial presence in all key markets, a worldwide clinical development capability and our R&D center of excellence in Switzerland. We have excellent new products - Opsumit, Veletri® (epoprostenol for injection) and soon, hopefully, Uptravi - and a solid pipeline to drive accelerated growth going forward. Most importantly, we have the right leadership and highly dedicated people to execute our strategy and maximize the value of our assets.

CORPORATE GOVERNANCE

Sound corporate governance and high standards of professional behavior are essential to our continued growth and success as a company. With this in mind, the Board of Directors and its subcommittees have met on several occasions throughout the year to critically review the company's progress.

In a referendum held in 2013, Swiss voters approved the so-called Minder Initiative, granting shareholders additional oversight on matters of executive compensation, and the Ordinance against Excessive Compensation in Listed Companies came into effect on January 1, 2014.

In response - a year ahead of the deadline - the Board proposed changes to our Articles of Association, to enable the company to implement practices ensuring full compliance with the new regulations. At the Annual General Meeting of shareholders in 2014, these proposals were approved by an overwhelming majority, and we would like to thank you for your ongoing support.

Shareholder engagement is crucial to our understanding of emerging issues, trends and expectations, and it fosters increased trust and support. In addition to our existing investor relations efforts, we have established a regular dialogue on corporate governance matters with shareholders and representatives of shareholder groups. Over the past few months, I have personally reached out to many of our largest shareholders - discussing general corporate governance, as well as compensation matters - and I look forward to continuing this dialogue in the future.

DELIVERING VALUE TO SHAREHOLDERS

Actelion's approach to business development has always involved seizing opportunities whenever they fit both our strategic and financial criteria. In the current, intensely competitive environment, we have assessed several options but have not yet found an appropriate opportunity that would create significant value for the company and, ultimately, for our shareholders. These efforts will be pursued, and - as a nimble company - we are well positioned to move rapidly and proactively should the right opportunity arise.

In the meantime, while ensuring the requisite financial flexibility, we will continue to return value to our shareholders.

In 2012, we made a commitment to return surplus capital to shareholders. We have delivered on that promise, with almost CHF 1.1 billion being returned through a second-line buyback program and dividend payments over the past three years.

In addition, during 2014, the company purchased 5.7 million shares on the first line of the Swiss Exchange to mitigate dilution arising from employee stock compensation programs.

Moving forward, and as part of our continued commitment to shareholder value creation, the Board will recommend that shareholders approve the payment of an increased dividend amounting to CHF 1.30 per registered share. In addition, the Board has authorized in principle, subject to approval by the relevant authorities, a new second-line share repurchase program of up to 10 million shares, within three years. The Board will then propose the cancelation of these repurchased shares at subsequent General Meetings of Shareholders.

OUTLOOK

In January 2015, the decision by the Swiss National Bank to discontinue the minimum exchange rate of CHF 1.20 per euro resulted in a sharp fall in Actelion's share price as part of a broad decline in the Swiss stock market. While only time will tell where exchange rates will settle, we must be mindful that - as most Swiss exporters - a strong Swiss franc will have a negative impact on Actelion's Swiss franc earnings.

Despite these increased currency headwinds, I am confident that, with our sound strategy and a culture rooted in science and innovation, we will continue to deliver for all our stakeholders - patients and physicians, employees and shareholders alike.

 

Yours sincerely,

Jean-Pierre Garnier,

Chairman of the Board of Directors



CEO'S LETTER TO SHAREHOLDERS

 

Dear Shareholders,

The highly successful launch of Opsumit® (macitentan) was one of the many highlights of 2014 - an impressive year of progress for Actelion. This unique drug for the treatment of pulmonary arterial hypertension (PAH) is now available in nearly 20 countries around the world, demonstrating both our commitment to the PAH community and our determination to maximize the value of our innovation. Having announced the positive results of the Phase III PAH outcome trial with selexipag (Uptravi®) in June, we submitted applications for marketing authorization to the European Medicines Agency (EMA) and to the US Food and Drug Administration (FDA) before the end of the year. Veletri® (epoprostenol for injection) continued to advance in the US, Japan, Canada, Australia and various EU markets, approaching an 80% share of new i.v. epoprostenol patients. Meanwhile, Tracleer® (bosentan) continued to perform strongly in markets where Opsumit is not yet available, and where it has been effectively defended against generic competition. These achievements are reflected in a strong commercial performance which, combined with rigorous financial discipline, allowed us once again to excel.

Sales reached CHF 1,956 million, up 12% at constant exchange rates (10% excluding US rebate reversals), and core earnings rose to CHF 743 million, up 25% at CER (20% excluding US rebate reversals), making 2014 a truly remarkable year for Actelion.

As a scientist, I know that our company's success is founded on innovation. I'm particularly proud of our achievements in the area of PAH, where our innovative products have provided benefits for patients around the world.

Our strategy for long-term value creation, set out in 2012, is being delivered around three key objectives - sustaining and growing our PAH franchise, building additional specialty franchises, and optimizing profitability. I am pleased to report that once again we have made significant progress on all three fronts.

SUSTAINING AND GROWING THE PAH FRANCHISE

Our success in the PAH arena began with Tracleer - the first and most successful ERA on the market to date. Despite the competitive landscape, which now includes generic bosentan in some countries, Tracleer is still holding its own in markets where Opsumit has not yet been launched. In addition, I am very proud that last year, Tracleer became the first PAH therapy to obtain a Pediatric Investigation Plan (PIP) compliance statement from the European Committee for Medicinal Products for Human Use (CHMP), with the European Commission Decision received in January of this year. With our pediatric formulation of Tracleer already available in Europe, the additional studies undertaken as part of the PIP have increased the information available for physicians treating children with PAH, underscoring our commitment to these patients. In addition, we can now apply for a 6-month patent extension in most European markets.

Our leading position in PAH has been reinforced by the launch of Opsumit in 2014 - a very strong market introduction in multiple geographies and healthcare systems. Opsumit is rapidly gaining new patient share in the ERA market, and early uptake momentum has been supported by patients switching therapy from Tracleer to Opsumit. The product's clinical utility has been enhanced - and physician acceptance strengthened - by a large and diverse set of data published over the past 18 months. As a result, more than 6,300 patients (about two-thirds in the US) were treated with Opsumit by the end of 2014. Our task now is to maintain the successful launch momentum in 2015, with further market introductions anticipated.

The excellent news announced in June 2014 was that selexipag, a selective oral prostacyclin receptor agonist (originally discovered by Nippon Shinyaku), demonstrated long-term outcome benefits in a trial involving over 1,100 patients: selexipag reduced the risk of a morbidity/mortality event by 39% versus placebo. At baseline, 80% of the patients in the study also received background therapy - an ERA, a phosphodiesterase-5 inhibitor, or a combination of the two - which makes the findings even more impressive. A vast amount of data on selexipag was generated in this study, and we have been gratified by the consistent efficacy observed across key subgroups. We are now eager to share the results with regulators and the PAH community. Submissions have already been filed with the major health authorities, and I look forward to the first presentations at the 2015 American College of Cardiology congress in March. I am convinced that selexipag has the potential to open the prostacyclin pathway to more patients, and once again Actelion is leading the way in PAH.

If approved, selexipag - together with Opsumit and Veletri - will provide us with a portfolio of products based on long-term outcome data. Our PAH franchise will have been transformed from a single product approaching patent expiry to a diversified, global franchise covering the continuum of care with outcome-based medicines.

BUILDING ADDITIONAL SPECIALTY FRANCHISES

Our specialty products outside of PAH also performed well in 2014. Zavesca® (miglustat) passed the CHF 100 million revenue threshold for the first time. This was mainly attributable to the Niemann-Pick type C disease indication, which - as a result of expanding diagnostic tools and heightened awareness - saw double-digit growth in the number of patients treated outside the US.

After just over a year on the market in the US, Valchlor® (mechlorethamine) gel is making progress in establishing itself in the cutaneous T-cell lymphoma (CTCL) market. 2014 has been a year of extensive learning for us in this new market, which has taken more time than initially anticipated. Our newly created sales force is now working with dermatologists in the CTCL centers of excellence and beyond, to shape the space for Valchlor within the treatment algorithm of the disease.

While we have built up an unrivaled PAH franchise over the past decade, we are also focusing our R&D efforts on other diseases with high unmet medical need.

We aim to expand the clinical utility of macitentan by conducting additional studies - both in specific PAH populations, such as pediatric patients and those with Eisenmenger's syndrome (PAH associated with a congenital heart defect), and in the broader pulmonary hypertension (PH) setting, including chronic thromboembolic pulmonary hypertension (CTEPH) and combined pre- and post-capillary pulmonary hypertension (CpcPH) due to left ventricular dysfunction. Finally, we are investigating the use of macitentan in other disorders where elevated endothelin levels appear to play a role, such as glioblastoma.

Progress is also being made with other highly promising compounds arising from our drug discovery efforts in other specialty areas. Cadazolid, a novel antibiotic for Clostridium difficile infections, is in Phase III development. Innovative approaches are being considered - and discussed with health authorities - for the further development of our S1P1 receptor modulator ponesimod in several indications. The ongoing extension study in multiple sclerosis is providing a substantial amount of long-term efficacy and safety data for this novel compound. However, I would reiterate that any pathway forward will carefully balance clinical risk and investment, medical need and commercial opportunity.

OPTIMIZING PROFITABILITY

When we announced our strategy in 2012, we committed to deliver profitable growth, and year after year we have exceeded expectations. While we aim to advance our pipeline over the coming years, you may rest assured that this investment in our future will not be at the expense of our profitability, which we will endeavor to maintain and even enhance in the medium term.

That said, our performance in 2014, even excluding the US rebate reversals, was truly outstanding, indeed making it more challenging to deliver continued growth in 2015. We are anticipating generic pressures for Ventavis® (iloprost) in the US and for Zavesca in the Type 1 Gaucher disease market, while continuing to roll out Opsumit and to prepare for the launch of Uptravi. Our commercial organization will therefore once again have to focus on excellence in execution, while the rest of the company keeps a tight control on costs and prioritizes the most important projects.

With all this in mind, barring unforeseen events and the benefit of US rebate reversal in 2014, we are forecasting 2015 core earnings growth, at constant exchange rates, to be in the low-single digit percentage range.

OUTLOOK

With the continued strong performance of Tracleer, the successful launch of Opsumit and the outstanding results obtained with selexipag, we have made considerable progress with our objective to transform our PAH business. Actelion is uniquely positioned to serve the PAH market, covering the continuum of care with outcome-based medicines. By offering the ERA and, potentially, the prostacyclin receptor agonist of choice, we could expand our market share in each segment.

Looking ahead, given the strength of our people and culture, of our marketed products and exciting pipeline, I am convinced that we can continue to create significant value for all our stakeholders. I would like to thank you, our shareholders, for your continued confidence in Actelion. Stay tuned as we move on to the next chapter of growth!

 

Yours sincerely,

Jean-Paul Clozel,

Chief Executive Officer

 

 

FINANCIAL UPDATE

 

CORE PERFORMANCE

Actelion continues to measure, report and issue guidance on its core operating results, which more accurately reflect the underlying business performance.

Core results exclude contract revenues, as well as costs related to employee stock-based compensation programs, depreciation, amortization, impairments, certain income tax effects and other items that management deems exceptional.

A full reconciliation between US GAAP and core results can be found on www.actelion.com:
http://www.actelion.com/.


Key highlights - year-to-date

      % variance
in CHF millions 2014  2013 in CHF at CER(1)
Product sales 1,956 1,784 10 12
Core R&D expenditure 369 356 4 4
Core earnings(2) 743 619 20 25
Core net income 648 509 27 34
Diluted core EPS (CHF) 5.58 4.41 27 33

 

Key highlights - quarterly

      % variance
in CHF millions Q4 2014 Q4 2013 in CHF at CER(1)
Product sales 468 462 1 0
Core R&D expenditure 115 105 9 9
Core earnings(2) 113 124 (9) (11)
Core net income 94 102 (7) (9)
Diluted core EPS (CHF) 0.81 0.87 (7) (9)

         

  1. CER percentage changes are calculated by reconsolidating both the FY 2014 and FY 2013 results at constant exchange rates (the average monthly exchange rates FY 2013).
  2. Actelion continues to measure, report and issue guidance on its core operating performance, which management believes more accurately reflects the underlying business performance. The Group believes that these non-GAAP financial measurements provide useful supplementary information to investors. These non-GAAP measures are reported in addition to, not as a substitute for, US GAAP financial performance.

         

PRODUCT SALES

Actelion's commercial performance during 2014 was strong across all regions with excellent underlying demand for key assets. In the US, despite unmitigated competitive pressures, sales increased by 16% driven by price increases and a net impact of CHF 42 million (at CER) reversals of rebate accruals relating to patient support programs (CHF 73 million in 2014 versus CHF 35 million in 2013). European sales increased by 10% at CER in a continually negative pricing environment. European sales growth was driven by the performance in Germany - the first EU market to launch Opsumit, and the digital ulcer indication, while Japan continued its strong performance, increasing by 9%. Sales in the rest of the world increased by 8% at CER, driven by strong growth in PAH-emerging markets such as China, Taiwan, Russia and Mexico. Comparing average exchange rates in 2014 with average exchange rates during 2013, the Swiss franc was stronger against many major currencies, in particular the Japanese yen and the US dollar. The overall impact resulted in a negative currency variance of CHF 51 million.


Sales by product - year-to-date

      % variance
in CHF millions  2014  2013 in CHF at CER
Opsumit 180 5 nm* nm
Tracleer 1,481 1,532 (3) (1)
Veletri 64 37 76 84
Ventavis 112 110 2 3
Valchlor 11 - nm nm
Zavesca 103 96 8 11
Others 5 4 nm nm
Total product sales 1,956 1,784 10 12

*nm = not meaningful

Sales by product - quarterly

      % variance
in CHF millions Q4 2014 Q4 2013 in CHF at CER
Opsumit 68 5 nm nm
Tracleer 328 393 (17) (17)
Veletri 18 11 63 62
Ventavis 26 27 (5) (11)
Valchlor 4 0 nm nm
Zavesca 22 23 (5) (5)
Others 2 1 nm nm
Total product sales 468 462 1 0

 

Sales by region - year-to-date

      % variance
in CHF millions 2014  2013 in CHF at CER
United States 879 768 14 16
Europe 717 660 9 10
Japan 185 188 (1) 9
Rest of the world 175 169 4 8
Total product sales 1,956 1,784 10 12

 

Sales by region - quarterly

      % variance
in CHF millions Q4 2014 Q4 2013 in CHF at CER
United States 207 208 0 (7)
Europe 174 164 6 8
Japan 49 51 (3) 3
Rest of the world 37 39 (5) (4)
Total product sales 468 462 1 0

 

PAH franchise

Opsumit®

Opsumit (macitentan) sales for 2014 amounted to CHF 180 million, reflecting a highly successful launch in several geographic regions. The robust long-term outcome data of Opsumit are perceived as clinically very relevant and differentiated from other ERAs on the market. Opsumit is rapidly gaining new patient ERA market share. At the end of 2014, over 6,300 patients were benefiting from the product. Additional important clinical data, further documenting the clinical utility of Opsumit, has been presented at various medical congresses throughout the year.

At the end of 2014, Opsumit was successfully launched in the United States, Germany, Austria, the UK, Ireland, Denmark, Sweden, the Netherlands, Australia, Italy, Belgium, Luxembourg, Canada, Finland, Mexico (marketed as Zependo®, private market), Norway, Iceland and Switzerland. Further launches will take place during 2015 and beyond, pending final price negotiations, which in some countries are proving to be more challenging than previously anticipated.

In Japan where the registration dossier was filed in June 2014, the regulatory process is proceeding well. The company also filed Opsumit in Russia, Turkey, China, Brazil and other Asian and Latin America markets.

Tracleer®

Tracleer (bosentan) sales amounted to CHF 1,481 million for 2014, a decrease of 1% at CER compared to the full year 2013 due to erosion in markets where Opsumit is available as well as in market price pressures and increased generic bosentan competition. Tracleer sales were supported by the digital ulcer indication in Europe as well as continued strong demand for Tracleer in markets where Opsumit is not yet available. US rebate reversals related to patient assistance programs and US price increases mitigated the decline to a certain extent. Underlying units sold globally decreased by 2%.

Amidst increased generic competition, Actelion is successfully defending Tracleer in markets like Canada, Turkey and Mexico. In addition, Actelion has introduced a generic bosentan in Brazil in 2012 and launched in Poland and Czech Republic branded generic bosentan under the name of Stayveer® to compete with generics. In the US, the compound patent for bosentan is expected to expire in November 2015.

Veletri®

Veletri (epoprostenol for injection) sales reached CHF 64 million for the full year 2014, an increase of 84% at CER compared to 2013 driven by successful launches in additional markets (i.e. Australia, the Netherlands, Spain). Japan continues to do very well, despite a price cut on 1 March 2014 of 5%. Veletri is well adopted approaching an 80% share of new of global i.v. epoprostenol patients. At the end of 2014, Veletri was available in the US, Japan (marketed as Epoprostenol "ACT"), UK, Spain, the Netherlands, Australia, New Zealand, Portugal, Poland, Belgium, the Czech Republic and Switzerland, Canada and Italy (marketed as Caripul®).

Ventavis®

During 2014, Ventavis (iloprost) had sales in the US of CHF 112 million, an increase of 3% at CER. This increase was driven entirely by price increases, and rebate reversals, as sales volumes eroded by 17% due to competitive pressures. These pressures are expected to intensify during 2015 as a consequence of potential generic entry.

Specialty Products

Valchlor®

Valchlor (mechlorethamine) sales for the full year 2014 amounted to CHF 11 million. Valchlor was launched in the US in November 2013 for Stage IA and IB mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL) in patients who have received prior skin-directed therapy. In March 2014, the expansion of the sales team was completed, and the company is now working with dermatologists beyond the CTCL Centers of Excellence. We are making progress in establishing Valchlor as an option in the treatment algorithm of early stage MF-CTCL.

Zavesca®

Zavesca (miglustat) sales amounted to CHF 103 million for the full year 2014, an increase of 11% at CER compared to the full year 2013. This performance was mainly driven by continued strong patient demand outside the US in the Niemann-Pick type C indication. In the type 1 Gaucher disease market, the performance of Zavesca remained strong, with relatively stable demand and positive price movement in the US. Underlying units sold increased by 14%. The company is anticipating competitive pressures in early 2015 as generic miglustat has been approved for the type 1 Gaucher indication in select European markets.

 

CORE OPERATING EXPENSES

 

      % variance
in CHF millions 2014  2013 in CHF at CER
Core cost of sales 212 208 2 4
Core R&D expenses 369 356 4 4
Core SG&A expenses 631 601 5 7
Core operating expenses 1,213 1,165 4 6

 

Core cost of sales

Core cost of sales for 2014 amounted to CHF 212 million, an increase of 4% at CER compared to the same period in 2013. Core cost of sales excludes an accretion expense of CHF 3 million related to Valchlor.

Core R&D expenses

Core R&D expenditure for 2014 increased by 4% compared to the prior year as investment in the earlier-stage pipeline and clinical trial expenses increased. Core R&D expenditure represented 19% of product sales in 2014. This level may increase going forward as several exciting opportunities are advancing through the pipeline. However, Actelion will continue to focus on carefully balancing investment in the right programs to ensure future growth with delivery of appropriate shareholder return.

Core SG&A expenses

Core SG&A increased by 7% at CER to CHF 631 million in 2014. This increase was driven entirely by costs related to the launches of Opsumit and Veletri in various markets around the globe as well as the set-up of a dedicated sales force for Valchlor. The G&A portion remains flat, as Actelion continues to carefully manage operating expenses.

CORE EARNINGS

 

      % variance
in CHF millions 2014 2013 in CHF at CER
Product sales 1,956 1,784 10 12
Core operating expenses (1,213) (1,165) 4 6
Core earnings 743 619 20 25

 

Core earnings amounted to CHF 743 million for the full year of 2014, compared to CHF 619 million during the same period of 2013, an increase of 25% at CER. Excluding the net core earnings impact (at CER) of CHF 38 million US rebate reversals (2014: CHF 66 million; 2013: CHF 32 million), core earnings rose by 20%, driven by a solid underlying operational performance and a continued focus on cost management.

 

CORE NET RESULTS

      % variance
in CHF millions  2014 2013 in CHF at CER
Core earnings 743 619 20 25
Core financial result (18) (13) - -
Core income tax (77) (97) - -
Core net income 648 509 27 34
Diluted core EPS (CHF) 5.58 4.41 27 33

A full reconciliation between US GAAP and core results is available from www.actelion.com.

The core financial expense of CHF 18 million relates mostly to interest paid on the CHF 235 million bond (maturing on 7 December 2015) and expenses related to the company's hedging programs.

The core tax expense of CHF 77 million translates into a core tax rate of 11%. This tax rate is a result of a mix of profit in the main countries in which the company operates.

Diluted core earnings per share were CHF 5.58 for the full year 2014, an increase of 33% at CER compared to the same period of 2013.

 

US GAAP RESULTS

      % variance
in CHF millions 2014 2013 in CHF at CER
Net revenue 1,958 1,786 10 12
Operating income 570 482 18 24
Financial result (33) (53) - -
Income tax 57 23 - -
Net income 594 453 31 38
Basic earnings per share (CHF) 5.34 4.06 32 39
Diluted earnings per share (CHF) 5.11 3.92 30 37

 

US GAAP operating income includes the following items excluded from core earnings (core operating income):

  • Milestone payment upon NDA filing of selexipag of USD 20 million (CHF 19 million)
  • Amortization of intangible assets of CHF 63 million (CHF 45 million in 2013), with the increase driven mostly by the amortization of Valchlor
  • Other depreciation and amortization of CHF 38 million (2013: CHF 39 million)
  • Stock-based compensation expenses of CHF 53 million (2013: CHF 50 million)

 

US GAAP net income includes the following items excluded from core net income:

  • Interest of CHF 10 million on a concluded litigation
  • Tax benefit of CHF 115 million mainly related to the release of a valuation allowance on US deferred tax assets
  • Tax effect of CHF 19 million on non-core operating expenses

 

CASH FLOW RECONCILED WITH NET CASH POSITION*

*Unrestricted net cash position includes unrestricted cash and cash equivalents plus short-term deposits minus long-term financial debt.

 

in CHF millions Twelve months ended 31 December 2014 Twelve months ended 31 December 2013
Operating cash flow (excluding litigation settlement) 616 592
Acquisition of tangible, intangible and other assets (31) (27)
Acquisition of a business (1) (231)
Operating free cash flow (excluding litigation settlement) 584 334
Litigation settlement (458) -
Cash released (restricted) for litigation 609 (250)
Dividend (133) (113)
Second-line share repurchase program - (417)
First-line share purchase (546) (58)
Proceeds from exercises of stock options 249 269
Other items 22 (10)
Free cash flow 327 (245)

Rounding differences may occur.

 

  • Operating cash flow, driven by the strong underlying business performance, was strong at CHF 616 million during the full year of 2014 (excluding the litigation settlement).
  • The company paid a litigation settlement of CHF 458 million in March 2014, out of restricted cash of CHF 609 million. The remainder (CHF 151 million) has been released.
  • The company continues to be pleased with cash collection particularly in southern Europe with days of sales outstanding (DSO) at a record low of 63 days.
  • On 15 May 2014, Actelion paid a dividend of CHF 1.20 per share amounting to a total of
    CHF 133 million to its shareholders.
  • During 2014, the company purchased 5.7 million shares (CHF 546 million) on the first-line of the Swiss Exchange to mitigate dilution arising from employee stock compensation programs. During the full year of 2014, Actelion employees exercised 4.8 million stock options resulting in proceeds of CHF 249 million.
  • Free cash flow for 2014 amounted to CHF 327 million (FY 2013: CHF (245) million), resulting in a gross cash position at year-end of CHF 1.2 billion.

  

ABBREVIATED BALANCE SHEET

in CHF millions Twelve months ended 31 December 2014 Twelve months ended 31 December 2013 Variance in CHF
Gross cash position* - Unrestricted 1,205 878 327
Gross cash position - Restricted - 613 (613)
Trade and other receivables, net 400 406 (6)
Other current assets 121 123 (2)
Tangible assets 368 381 (13)
Intangible assets 441 465 (24)
Goodwill 134 126 8
Other non-current assets 78 38 41
Total assets 2,748 3,030 (282)
Litigation provision - 456 (456)
Other current liabilities 429 516 (86)
Financial debt 235 235 0
Other non-current liabilities 163 114 49
Total liabilities 827 1,321 (493)
Share capital and accumulated reserves 2,208 2,252 (43)
Treasury shares (288) (543) 255
Total shareholders' equity 1,920 1,709 211
Total liabilities and shareholders' equity 2,748 3,030 (282)

 *Gross cash position includes cash, cash equivalents and short-term deposits.

Rounding differences may occur.

 

CLINICAL DEVELOPMENT UPDATE

Actelion's promising R&D pipeline comprises novel compounds addressing a broad range of diseases, including cardiovascular and immunological disorders as well as central nervous system disorders and infectious disease.


Actelion's late-stage product candidates include the novel antibiotic cadazolid under investigation for Clostridium difficile-associated diarrhea (CDAD).

 

Phase Compound Indication Study Status
III Cadazolid Clostridium difficile-associated diarrhea IMPACT Ongoing
III Macitentan Eisenmenger syndrome MAESTRO Ongoing
III Selexipag PAH GRIPHON Submissions ongoing
II Ponesimod Multiple sclerosis Extension study Ongoing
II Macitentan Chronic thromboembolic pulmonary hypertension MERIT Ongoing
II Macitentan Combined pre- and post-capillary pulmonary hypertension MELODY Ongoing
II Selexipag Raynaud's phenomenon secondary to systemic sclerosis - Ongoing
I Ponesimod Immunological Disorders - Phase II in preparation
I Lucerastat Lipid storage disorders - Phase II in preparation
I S1P1 modulator Immunological disorders - Phase II in preparation
I Macitentan Glioblastoma - Ongoing
I New Chemical Entity Cardiovascular Disorders - Ongoing

 

HUMAN RESOURCES

At the end of 2014, Actelion employed 2,470 permanent employees worldwide, an increase of 3% (or 74 permanent positions) compared to the end of 2013. 

ABOUT ACTELION LTD.

Actelion Ltd. is a leading biopharmaceutical company focused on the discovery, development and commercialization of innovative drugs for diseases with significant unmet medical needs.

Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our portfolio of PAH treatments covers the spectrum of disease, from WHO Functional Class (FC) II through to FC IV, with oral, inhaled and intravenous medications. Although not available in all countries, Actelion has treatments approved by health authorities for a number of specialist diseases including Type 1 Gaucher disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.

Founded in late 1997, with now over 2,400 dedicated professionals covering all key markets around the world including Europe, the US, Japan, China, Russia and Mexico, Actelion has its corporate headquarters in Allschwil / Basel, Switzerland.

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®). All trademarks are legally protected.

 

For further information please contact:

Andrew Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com:
http://www.actelion.com/

 


Webcast:
http://view-w.tv/p/120-121-15379/en
Financial Statement:
http://hugin.info/131801/R/1894511/671641.pdf
Financial Fact Sheet:
http://hugin.info/131801/R/1894511/671640.pdf
Press Release PDF:
http://hugin.info/131801/R/1894511/671638.pdf



This announcement is distributed by NASDAQ OMX Corporate Solutions on behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Actelion Pharmaceuticals Ltd via Globenewswire

HUG#1894511

--- End of Message ---

Actelion Pharmaceuticals Ltd
Gewerbestrasse 16 Allschwil Switzerland

ISIN: CH0010532478;