On October 20, 2015 Actelion Ltd (SIX: ATLN) reported its results for the first nine months of 2015 (Press release, Actelion, OCT 19, 2015, View Source [SID:1234507904]).

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OPERATING HIGHLIGHTS

Opsumit (macitentan) – continues strong launch trajectory
Opsumit (macitentan) – commercially available in over 30 countries including Japan
Selexipag (Uptravi) – regulatory procedures on track
Specialty pipeline – strengthens as several promising compounds advance

FINANCIAL HIGHLIGHTS

Product sales of CHF 1,522 million – strong growth driven by Opsumit uptake of
CHF 354 million
Core earnings of CHF 651 million – increased operational leverage
2015 financial guidance upgrade: Crossing the 20% mark for core earnings growth at CER (excluding 2014 US rebate reversals)
Return to shareholders: CHF 808 million via share repurchase program and dividend

CER percentage changes are calculated by reconsolidating both the 9M 2014 and 9M 2015 results at constant currencies (the average monthly exchange rates for 9M 2014).

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: "The transformation of Actelion is now well underway. Our PAH franchise has evolved from a single product into a portfolio of outstanding products, which address the continuity of care in this serious disease. The PAH portfolio should soon be complemented by selexipag, as regulatory procedures continue on track. Our pipeline outside PAH is also undergoing a transformation with several promising compounds advancing in the clinic. Thanks to our financial discipline we are transforming the company while growing our profitability, allowing us to return significant value to our shareholders."

Otto Schwarz, Chief Operating Officer, commented: "With sales of 354 million Swiss francs in the first nine months of this year and almost 11,800 patients on treatment, Opsumit continues its strong launch momentum, supported by new launches such as in Japan. As a result, we have seen Actelion gaining share in the ERA market in addition to expanding the ERA market through more combination therapy. Based on its comprehensive outcome benefits in mono- and combination therapy, Opsumit is uniquely positioned to become the ERA of choice across markets globally."

André C. Muller, Chief Financial Officer, commented: "We are particularly pleased with the strong third quarter performance as the launch momentum for Opsumit continues unabated. These strong results give us increased confidence that earnings will grow more than previously anticipated. Therefore, we now expect core earnings growth – at constant exchange rates and excluding US rebate reversals – to cross the 20% mark."

SALES UPDATE

Actelion’s commercial performance in the first nine months of 2015 continues to be strong, driven by the successful uptake of Opsumit, consistently strong recruitment of new patients across markets, and ERA market expansion due to increased combination therapy with PDE5 inhibitors.

In the US, sales increased by 21% at CER (excluding 2014 rebate reversals), driven by Opsumit momentum and ERA market share gains. Despite continued pricing pressure and market erosion from generics, European sales increased by 2% at CER with growth driven mostly by Opsumit launches and Tracleer use in the digital ulcer indication. Sales in Japan increased by 7% at CER in a competitive environment, driven by sales of Opsumit (launched in late June), Veletri and Zavesca (Japanese trade name Brazaves). Sales in the rest of the world increased by 1% at CER.

Comparing average exchange rates for the first nine months of 2015 to the first nine months of 2014, the Swiss franc appreciated against most major currencies except the US dollar, resulting in a negative currency variance of 40 million Swiss francs.

PAH FRANCHISE

Opsumit

Sales of Opsumit (macitentan) amounted to 354 million Swiss francs for the first nine months of 2015, reflecting the continued highly successful launch, with commercial availability in over 30 countries. The patient recruitment trend continued with almost 11,800 patients on drug at the end of September 2015. The strong enrollment is driven by an increased market share of ERA naïve patients together with increased early combination with PDE5 inhibitors.

Tracleer

Sales of Tracleer (bosentan) amounted to 934 million Swiss francs for the first nine months of 2015, a decrease of 10% at CER compared to the first nine months of 2014 excluding the impact of prior-year US rebate reversals. This decrease is mostly a consequence of lower volumes in countries where Opsumit is available due to lower enrollments of new patients as well as switches to Opsumit. Underlying units sold globally decreased by 7%.Tracleer sales were further impacted by continued pricing pressure in Europe, increased generic bosentan competition and competitive pressures in Japan. Positively, Tracleer sales were supported by the digital ulcer indication in Europe and continued solid demand in markets where Opsumit is not yet available.

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 Denmark, Finland, France, Ireland, the Netherlands and Sweden.

Veletri

Sales of Veletri (epoprostenol for injection) amounted to 60 million Swiss francs for the first nine months of 2015, an increase of 40% at CER compared to the first nine months of 2014 and excluding the impact of prior-year US rebate reversals. 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"). At the end of September 2015, Veletri was available in 15 countries globally.

Ventavis

Sales of Ventavis (iloprost) amounted to 81 million Swiss francs for the first nine months of 2015, a decrease of 5% at CER compared to the first nine months of 2014, or 11% lower including the impact of prior-year US rebate reversals. The underlying unit decrease of 22% is due to continued competitive pressure.

SPECIALTY PRODUCTS

Valchlor

Sales of Valchlor (mechlorethamine) for the first nine months of 2015 amounted to 19 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 68 million Swiss francs for the first nine months of 2015, a decrease of 8% at CER compared to the first nine months of 2014 excluding the impact of prior-year rebate reversals. Underlying units sold decreased by 3%. Sales in the US were lower, mainly due to competitive pressure in type 1 Gaucher disease. Outside the US, Zavesca sales were almost stable, with increased patient demand in the Niemann-Pick type C indication, particularly in Japan (where it is marketed as Brazaves). Sales were offset by the 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.

A full financial review is available on www.actelion.com

CLINICAL 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). The results from the Phase II study of cadazolid in CDAD were recently published in two articles covering clinical and microbiological results respectively: T. Louie et al., A Multicenter, Double-Blind, Randomized, Phase 2 Study Evaluating the Novel Antibiotic, Cadazolid, in Patients with Clostridium difficile Infection (Antimicrob. Agents Chemother. 2015;59(10):6266-73), and D.N. Gerding et al., Susceptibility of Clostridium difficile Isolates from a Phase 2 Clinical Trial of Cadazolid and Vancomycin in C. difficile infection (J. Antimicrob. Chemother., available online doi:10.1093/jac/dkv300).

Actelion provided a clinical pipeline update in the Half-Year Report, published on 21 July 2015. All programs are on track with the following updates:

Actelion has initiated a Phase IIIb study, TRITON, to compare the efficacy and safety of an initial triple oral treatment regimen (macitentan, tadalafil, selexipag) versus an initial dual oral treatment regimen (macitentan, tadalafil, placebo) in newly diagnosed, treatment-naïve patients with pulmonary arterial hypertension.

Following interactions with regulatory authorities, Actelion has decided to initiate a limited Phase II study with clazosentan, an intravenous selective endothelin A receptor antagonist. The study will evaluate whether clazosentan has an early effect in reversing established cerebral vasospasm in patients with aneurysmal subarachnoid hemorrhage. The study will be initiated in the coming months.

Actelion’s Phase I cardiovascular compound, a new endothelin receptor antagonist, is expected to advance into Phase II clinical development in patients with essential hypertension to establish a dose-effect relationship. The results from this study will form the basis for development decisions in specialty cardiovascular disorders.

Finally, a New Chemical Entity has entered into Phase I development for neurological disorders, adding to our central nervous system pipeline.