Actelion has posted its full-year results which show that revenues fell 7% and the Swiss biotech is predicting a tough 2012.
Net loss was 146.3 million Swiss francs, about $160 million, compared with income of 390.6 million francs for the previous year. The figures were hit by a provision to cover damages in connection with its legal tussle in the USA with Japan's Asahi Kasei Pharma Corp over the heart disease drug fasudil.
Revenues came in 1.80 billion francs, impacted by the strength of the Swiss currency and increasing competition to its pulmonary arterial hypertension blockbuster Tracleer (bosentan).
Sales for the latter fell 7% to 1.52 billion francs. The problem for Actelion is that a rival PAH product, Gilead Sciences' Letairis (ambrisentan) is selling well in the USA, boosted last year by the US Food and Drug Administration's decision to approve a change to the label that removed a warning about potential liver injury. Indeed, 2011 Letairis sales rose 22% to $293 million.
As for the Allschwil-based group’s other products, sales of Ventavis (iloprost), an inhaled therapy for the treatment of PAH, were down 10.4% to 106.4 million francs. Turnover of Zavesca (miglustat), for patients with Gaucher disease for whom enzyme replacement therapy is not a therapeutic option, slipped 0.5% to 68.7 million francs.
Chief executive Jean-Paul Clozel said that "following 10 years of strong sales growth, a very difficult pricing environment and a maturing product portfolio will result in a transition period in which we are preparing for new products to reach the market". He added that Actelion's focus now is on its Phase III trial of macitentan, its successor to Tracleer, the top-line results for which are due in the second quarter.
Dr Clozel concluded by saying that later this year, the company expects to initiate the Phase III program for ponesimod in multiple sclerosis and " finalise the evaluation of potential strategic partnerships" for the latter and for setipiprant in allergic rhinitis.
Andrew Oakley, Actelion's chief financial officer, noted that the results have been adversely affected by the ongoing economic crisis, claiming that "prices for medications are under pressure and the worsening sovereign debt crisis required additional provisions". For 2012, product sales - in local currencies - are expected to decrease in the low-to-mid single digit range, due to increased pricing pressure globally and rising competition in the USA.