OREANDA-NEWS. Actelion Ltd (SIX: ATLN) today announced its results for the first three months of 2016.

OPERATING HIGHLIGHTS

  • Excellent Opsumit® (macitentan) trajectory sustained

  • Outstanding early US launch momentum for Uptravi® (selexipag)

  • Significant recruitment drive into Phase III programs

  • 3 New compounds delivered from Drug Discovery to the clinic

FINANCIAL HIGHLIGHTS

  • Product sales of CHF 589 million (+11% at CER)

  • Opsumit sales grow to CHF 178 million

  • Uptravi sales of CHF 35 million - enhanced by launch inventory

  • Core operating income of CHF 249 million (+8% at CER)

  • 2016 financial guidance upgrade: High single-digit percentage core operating income growth, at constant exchange rates and barring unforeseen events

      % variance
in CHF millions
(except for per share data)		 3M 2016 3M 2015  in CHF at CER(1)
US GAAP results        
Net revenue 590 515 14 11
Operating income 208 190 10 3
Net income 178 159 12 5
Diluted EPS 1.64 1.38 19 11
Core performance(2)        
Product sales 589 515 14 11
Core operating income 249 218 14 8
Core net income 215 185 16 10
Core diluted EPS 1.98 1.61 23 17

Cash flow 3M 2016 3M 2015
Operating cash flow 172 94
Capital expenditure -5 -6
Free cash flow 67 -57
Net cash position as of 31 March 472 913

  1. CER percentage changes are calculated by reconsolidating both the 3M 2015 and 3M 2016 results at constant currencies (the average monthly exchange rates for 3M 2015).

  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: "Actelion has started the year very well. Opsumit continues on its exceptional launch trajectory and Uptravi is off to an excellent start - much better than anyone could have expected. Our other products are also performing well, our pipeline projects are advancing and our discovery efforts continue to deliver compounds into the clinic. With the business performing better than anticipated, even while launching new products and investing in future products, I am confident to upgrade our financial guidance."

Otto Schwarz, Chief Operating Officer, commented: "We are very pleased with the Uptravi launch in the United States. After almost three months, approximately 650 patients are on treatment with Uptravi. We assume the majority of patients are now benefitting from an all-oral triple combination therapy. The Opsumit launch momentum continues across all regions and markets. Our outcome-based PAH portfolio now accounts for 40% of our sales, with Tracleer for the first time contributing less than 50% of sales, thus demonstrating the progress in the transformation of our PAH business."

Andr? C. Muller, Chief Financial Officer, commented: "The strong start to 2016, along with some more clarity on a number of factors - including the strong Opsumit and Uptravi launch dynamics and stable pricing in Japan for Opsumit and Tracleer - enables us to increase the outlook for the full year. Barring unforeseen events, we now expect high single-digit percentage core operating income growth, at constant exchange rates."

SALES UPDATE

Actelion delivered an outstanding first quarter driven by the continued successful uptake of Opsumit, a very strong Uptravi launch, consistently strong recruitment of new PAH patients across markets, and ERA market expansion due to increased combination therapy with PDE-5 inhibitors.

In the US, sales increased by 25% at CER, driven by the strong Uptravi launch, continued Opsumit momentum and ERA market share gains. European sales were flat at CER with increased Opsumit uptake and Tracleer use in the digital ulcer indication offset by continued pricing pressure and market erosion from generics. Sales in Japan increased by 11% at CER and were driven by Opsumit (launched in June 2015), Veletri, and Zavesca (Japanese trade name Brazaves). Sales in the rest of the world decreased by 14%, at CER.

Comparing average exchange rates for the first three months of 2016 to the first three months of 2015, the Swiss franc weakened, mostly against the US dollar and the Euro, resulting in a positive currency variance of 17 million Swiss francs.

Sales by product - year-to-date

      % variance
in CHF millions  3M 2016  3M 2015 in CHF at CER
Opsumit® 178 95 88 82
Tracleer® 290 344 -16 -18
Uptravi® 35 - - -
Veletri® 24 19 24 20
Ventavis® 27 31 -15 -18
Valchlor® 9 5 88 80
Zavesca® 25 20 27 26
Others 2 2 23 30
Total product sales 589 515 14 11

Sales by region - year-to-date

      % variance
in CHF millions  3M 2016  3M 2015 in CHF at CER
United States 327 252 30 25
Europe* 164 162 1 0
Japan 50 42 20 11
Rest of the world 49 59 -18 -14
Total product sales 589 515 14 11

*Europe = EU28 and Switzerland

PAH FRANCHISE
Opsumit®
Sales of Opsumit (macitentan) amounted to 178 million Swiss francs for the first three months of 2016, an increase of 82% at CER compared to the first three months of 2015. This increase is driven by the continued uptake trajectory with commercial availability in over 30 countries. The strong enrollment continues to be driven by treatment-na?ve patients together with increased early combination with PDE-5 inhibitors.

Uptravi®
Sales of Uptravi (selexipag) amounted to 35 million Swiss francs since the product was launched in the United States on 4 January 2016. Of this total amount, approximately 20 million Swiss francs can be attributed to the launch inventory as Uptravi is available in 10 different presentations across the various doses. At the end of March, approximately 650 patients were using this outcome-based, oral selective IP receptor agonist, originally discovered by Nippon Shinyaku.

Market authorization has so far been received from the US FDA (21 December 2015) and Health Canada (20 January 2016), New Zealand's Medsafe (17 March 2016) and Australia's TGA (18 March 2016). In Europe, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Uptravi for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with WHO functional class (FC) II-III, either as combination therapy in patients insufficiently controlled with an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 (PDE-5) inhibitor, or as monotherapy in patients who are not candidates for these therapies. A CHMP positive opinion is one of the final steps before marketing authorization is granted by the European Commission. The European Commission is expected to issue a final decision in the coming months.

Submission of the registration dossier to other health authorities is ongoing, with regulatory reviews underway in Japan, South Korea, Switzerland, Taiwan and Turkey.

Tracleer®
Sales of Tracleer (bosentan) amounted to 290 million Swiss francs for the first three months of 2016, a decrease of 18% at CER compared to the first three months of 2015. This decrease is mostly a consequence of lower volumes in countries where Opsumit is availabledue to lower enrollments of new patients as well as switches to Opsumit. Underlying units sold globally decreased by 14%. Tracleer sales were further impacted by continued pricing pressure in Europe and increased generic bosentan competition, notably in Spain. Positively, Tracleer sales were supported by the digital ulcer indication in Europe, the DU launch in Japan and continued solid demand in markets where Opsumit is not yet available. In March 2016, Actelion Japan was notified that the biannual Japanese pricing review would lead to no change.

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 and have been granted in 15 of those.

Veletri®
Sales of Veletri (epoprostenol for injection) amounted to 24 million Swiss francs for the first three months of 2016, an increase of 20% at CER compared to the first three months of 2015. The increase was mostly driven by increased market penetration, successful launches in additional markets, notably in France - the biggest European i.v. epoprostenol market in terms of prostacyclin patients - and continued growth in Japan (where it is marketed as Epoprostenol "ACT"). In March 2016, Actelion Japan was notified of an average 12% price cut for Veletri, effective 1 March 2016. At the end of March 2016, Veletri was available in 15 countries globally.

Ventavis®
Sales of Ventavis (iloprost) amounted to 27 million Swiss francs for the three months of 2016, a decrease of 18% at CER compared to the first three months of 2015. The underlying unit decrease of 24% is due to continued competitive pressure.

SPECIALTY PRODUCTS
Valchlor®
Sales of Valchlor (mechlorethamine) for the first three months of 2016 amounted to 9 million Swiss francs. In the US, the company is continuing its efforts to establish Valchlor as an option in the treatment algorithm for early-stage mycosis fungoides, a type of 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 regulatory dossier is currently under review with the European Medicines Agency (under the trade name Ledaga®).

Zavesca®
Sales of Zavesca (miglustat) amounted to 25 million Swiss francs for the first three months of 2016, an increase of 26% at CER compared to the first three months of 2015. Underlying units sold increased by 15%. Sales in the US were strong due to a very low prior year base as a consequence of last year's inventory adjustment. In Europe, sales were lower by 5% mainly due to launch of generic miglustat, which has become commercially available (approved for the type 1 Gaucher disease indication only) in Spain, Sweden and the Czech Republic. Sales in Japan (where it is marketed as Brazaves®) were 13% higher driven by increased patient demand in the Niemann-Pick type C indication.

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 2,500 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.