OREANDA-NEWS. Actelion Ltd (SIX: ATLN) today announced its results for the full year 2015.

OPERATING HIGHLIGHTS

  • Opsumit - Strong, sustained launch trajectory across markets  

  • Uptravi - Approved and launched in the US

  • Uptravi - EU filing resulted in positive CHMP opinion

  • Pipeline - Advancing late-stage assets

  • Pipeline - Significant progress in discovery and early-stage development

FINANCIAL HIGHLIGHTS

  • Product sales cross CHF 2 billion - driven by excellent Opsumit sales (CHF 516 m)

  • Core earnings of CHF 814 million, up 14% at CER (up 25% ex US rebate reversals)

  • Core EPS of CHF 6.16, an increase of 15% at CER

  • Almost CHF 1 billion returned to shareholders through share repurchase and dividend

  • Board to propose increased dividend of CHF 1.50

  • 2016 guidance: Low single-digit percentage core operating income growth at CER

  

      % variance
in CHF millions
(except for per share data)		 2015 2014  in CHF at CER(1)
US GAAP results        
Net revenue 2,045 1,958 4 7
Operating income 656 570 15 21
Net income 552 594 -7 -3
Diluted EPS 4.91 5.11 -4 1
Core performance(2)        
Product sales 2,042 1,956 4 7
Core earnings 814 743 9 14
Core earnings ex 2014 US rebate reversals 814 677 20 25
Core net income 693 648 7 11
Diluted core EPS 6.16 5.58 10 15

Cash flow 2015 2014
Operating cash flow 658 616
Capital expenditure (44) (31)
Cash returned shareholders 927 133
Free cash flow (800) 327
Net cash position 405 1,205

  1. CER percentage changes are calculated by reconsolidating both the 2014 and 2015 results at constant currencies (the average monthly exchange rates for 2014).

  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.

             

Jean-Paul Clozel, MD, Chief Executive Officer, commented: "2015 was an outstanding year for Actelion, with record sales and earnings. More importantly for me, these outstanding financial results have been accompanied by significant transformation of the company. With the impressive take-off of Opsumit and with Uptravi now on the market, we have a great platform to build and invest in our future. We have transformed our PAH portfolio and the diversification of our pipeline is well underway. As a result, we now have the opportunity to become the first European-born biopharma to make it to the major league."

Otto Schwarz, Chief Operating Officer, commented: "The excellent launch momentum of Opsumit, across all markets, has resulted in more than 13,600 patients on therapy at the end of 2015. Following the US approval of Uptravi and subsequent launch in January of this year, we are now working diligently to ensure more patients can benefit from this novel treatment targeting the prostacyclin pathway. With Opsumit, Uptravi and Veletri, we are uniquely positioned to build and serve the PAH community, covering the continuum of care with outcome-based medicines."

Andre C. Muller, Chief Financial Officer, commented: "Actelion has delivered an excellent performance in 2015. Our commercial operations have delivered sales of more than 2 billion Swiss francs, despite the sudden appreciation of the Swiss franc in January 2015. This strong performance along with tight financial discipline demonstrated the earnings power of our business with core earnings growing more than twice as fast as sales."

Barring unforeseen events, Actelion forecasts 2016 core operating income, at constant exchange rates, to grow in the low single-digit percentage range. This expectation involves a number of assumptions including Opsumit and Uptravi launch dynamics, generic pressures mainly in the US and pricing pressure in Europe and Japan.

KEY PERFORMANCE INDICATORS

PRODUCT SALES
Actelion's excellent commercial performance during 2015 was mainly due to the continued strong uptake of Opsumit, driven by consistently strong recruitment of new patients across markets and expansion of the endothelin receptor antagonist (ERA) market due to increased combination therapy with PDE-5 inhibitors.
In the US, sales increased by 21% at CER, excluding 2014 rebate reversals, and were driven by Opsumit uptake, ERA market share gains and ERA market expansion, as well as price increases across the portfolio. European sales increased by 3% at CER despite continued pricing pressure and market erosion from generics, with growth driven mostly by new Opsumit markets and use of Tracleer in the digital ulcer indication.
Sales in Japan increased by 11% at CER in a competitive environment. Growth was driven by sales of Opsumit (launched in late June 2015), Tracleer in the digital ulcer indication (launched in September 2015), Veletri and Zavesca (Japanese trade name Brazaves®).

Comparing average exchange rates for 2015 with 2014, the Swiss franc appreciated against most major currencies except the US dollar, resulting in a negative currency variance of 55 million Swiss francs.

PAH franchise

Opsumit®
Sales of Opsumit (macitentan) amounted to 516 million Swiss francs, reflecting a sustained highly successful launch. Opsumit is now available to patients in over 35 countries and gaining ERA market share in all geographies. Strong patient demand continued, with more than 13,600 patients on therapy at the end of December 2015 (almost 50% from the US). Patient growth was driven by an increasing market share in the ERA-naive patient segment and increased combination with PDE-5 inhibitors, as well as new market launches (e.g. Japan, Israel).

Tracleer®
Sales of Tracleer (bosentan) amounted to 1,212 million Swiss francs, a decrease of 11% at CER excluding 2014 US rebate reversals. This decrease is mostly attributed to lower volumes in countries where Opsumit is available, due to sharply decreased enrollment of new patients. Sales were further impacted by continued pricing pressure in Europe and increased generic bosentan competition. Underlying units sold globally decreased by 6%.

Following the Pediatric Investigation Plan (PIP) compliance statement from the European Committee for Medicinal Products for Human Use (CHMP), applications for extension of the Supplementary Protection Certificate (SPC) were filed in 19 EU countries. Extensions of patent protection for Tracleer have now been granted in Belgium, Denmark, Finland, France, Italy, Ireland, Luxembourg, the Netherlands, Spain and Sweden.

Tracleer sales were positively supported by the digital ulcer (DU) indication in Europe and Japan (launched in September 2015), a price increase in the US and continued solid demand in markets where Opsumit is not yet available. Overall, more than 46,000 patients were receiving the drug globally at the end of 2015 (a decrease of 9% versus prior year).

Veletri®
Sales of Veletri (epoprostenol for injection) amounted to 83 million Swiss francs, an increase of 37% at CER, excluding 2014 US rebate reversals, with over 1,900 patients receiving the drug at the end of 2015. The increase was mostly driven by increased market penetration, successful launches in additional markets - notably in France, Europe's biggest i.v. epoprostenol market - and continued growth in Japan. At the end of December 2015, Veletri was available in 15 countries worldwide.

Ventavis®
Sales of Ventavis (iloprost) amounted to 105 million Swiss francs, a decrease of 7% at CER, excluding the impact of prior year US rebate reversals. The underlying 20% unit decrease due to continued competitive pressure was mitigated by price increases.

Specialty Products

Valchlor®
Sales of Valchlor (mechlorethamine) amounted to 27 million Swiss francs. In the US, the company is continuing its efforts to establish Valchlor as a first-line option in the treatment algorithm for early-stage mycosis fungoides-type cutaneous T-cell lymphoma (MF-CTCL).

In France, patients benefited from the drug under a temporary authorization for use ("ATU") program initiated during the second half of 2014. The dossier for Valchlor (under the trade name Ledaga®) was accepted by the European Medicines Agency during the second quarter of 2015 and is currently under review.

Zavesca®
Sales of Zavesca (miglustat) amounted to 92 million Swiss francs, a decrease of 3% at CER, excluding the impact of prior year US rebate reversals. Underlying unit sales were flat compared to the prior year.

Sales in the US declined mainly as a result of competitive pressure from alternative enzyme replacement therapy (ERT) options for the type 1 Gaucher disease (GD1) indication. In Europe, a decline in the GD1 business due to generic competition in selected markets was mitigated by increased patient demand in the Niemann-Pick type C indication, driven by Japan (where it is marketed as Brazaves®), Italy, France and Russia. At the end of 2015, generic miglustat (approved for GD1 only) was commercially available in Spain, Sweden, Germany and the Czech Republic.

CORE R&D EXPENDITURE
Core R&D expenses amounted to 404 million Swiss francs, an increase of 10% at CER. This increase was driven by higher clinical trial expenses, as the company is advancing its specialty immunology portfolio, macitentan life-cycle extensions and other late-stage pipeline assets, as well as continued investment in the earlier-stage pipeline. Core R&D expenditure represented 20% of product sales, slightly higher than in 2014. Actelion will continue to focus on carefully balancing investments so as to ensure future growth and delivery of appropriate shareholder returns.

CORE EARNINGS
Core operating income amounted to 814 million Swiss francs, an increase of 14% at CER. Excluding the impact of prior-year US rebate reversals, core operating income increased by 25% at CER. The strength of the Swiss franc against most currencies except the US dollar had a negative impact of 32 million Swiss francs on core operating income.

CORE EPS
Diluted core earnings per share were CHF 6.16 for the full year 2015, an increase of 15% at CER compared to the same period of 2014.

DELIVERING VALUE TO SHAREHOLDERS
Actelion has continued to make significant progress in delivering on its strategy for value creation. The year's highlights include the continued very successfully Opsumit launch as well as the FDA approval of Uptravi. A strong commercial performance, combined with tight financial oversight, was reflected in Actelion's share price: with an increase of 21%, the company was one of the top performers on the Swiss Market Index (SMI). Including the dividend, total shareholder return amounted to 22%. Market capitalization at the end of 2015 was 15.9 billion Swiss francs.

In 2012, Actelion made a commitment to return significant capital to shareholders. The company has delivered on that promise, with over 2 billion Swiss francs being returned to shareholders in the form of dividends and share repurchase programs over the past four years. The Board of Directors will also propose an increased annual dividend payment of CHF 1.50 for approval by shareholders at the upcoming Annual General Meeting in May.
  

PIPELINE 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 diseases.

Actelion's late-stage product candidates include the novel antibiotic cadazolid, under investigation for Clostridium difficile-associated diarrhea (CDAD) and a S1P1 receptor modulator, ponesimod, investigated in multiple sclerosis.

Phase Compound Indication Study Status
Registration Selexipag PAH GRIPHON Regulatory reviews ongoing
III Cadazolid Clostridium difficile-associated diarrhea IMPACT Ongoing
III Macitentan Eisenmenger syndrome MAESTRO Ongoing
III Ponesimod Multiple sclerosis OPTIMUM Ongoing
II Clazosentan Reversal of vasospasm associated with aneurysmal subarachnoid hemorrhage REVERSE Initiating
II Endothelin Receptor Antagonist Specialty cardiovascular disorders - Initiating
II Macitentan Chronic thromboembolic pulmonary hypertension MERIT Ongoing
II Macitentan Combined pre- and post-capillary pulmonary hypertension MELODY Complete
II Ponesimod Graft-versus-host disease - Ongoing
II Cenerimod Systemic lupus erythematosus - Ongoing
Ib Lucerastat Fabry disease - Ongoing
I NCE Neurological disorders - Ongoing
I NCE Neurological disorders - Ongoing
I NCE Cardiovascular disorders - Ongoing

HUMAN RESOURCES
At the end of 2015, Actelion employed 2,547 permanent employees worldwide, an increase of 3% (or 77 permanent positions) compared to the end of 2014.      
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 also 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 2,500 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.