ZURICH (Reuters) - Actelion, Europe’s largest biotech company, confirmed its full-year outlook on Thursday ahead of a widely anticipated approval of its big drug hope Opsumit by U.S. health regulators later this week.
Nine month sales of its main product Tracleer, a treatment for pulmonary arterial hypertension (PAH), rose 3 percent to 1.138 billion Swiss francs ($1.24 billion). Net profit was 105 million francs in the third quarter, beating analysts’ forecasts of 88.5 million.
The U.S. Food and Drug Administration (FDA) is due to decide on October 19 whether to approve Actelion’s Opsumit, a follow-on product to Tracleer, which has faced growing competition from Gilead’s Letairis.
Stellar data for Opsumit - which also treats PAH - has restored investors’ confidence in Actelion’s ability to secure future sales and profits even when Tracleer goes off patent from 2015.
The company is the best performer on the Swiss blue-chip index so far this year and the shares have shot up almost 8 percent in the last week alone, as investors grow increasingly confident of a green light from the FDA.
But some analysts have warned of the possibility that the FDA will slap a black box warning on Opsumit requiring mandatory liver testing, which could suppress sales in the short run.
An earlier upgrade to its full-year profit forecast and a late-stage study into another promising lung drug, selexipag, have further brightened the mood around the company.
Actelion on Thursday confirmed its forecast for core earnings to rise by more than 10 percent in 2013.
Due to growth being brought forward into this year and increased spending on marketing following Opsumit’s anticipated approval, Actelion expects at least stable core earnings in 2014. It has forecast growth in at least the single-digit range in 2015.
Shares in Actelion trade at 15.1 times forward earnings, at a premium to the European sector medium at 14.4 times. ($1 = 0.9160 Swiss francs)
Reporting by Alice Baghdjian and Caroline Copley; Editing by David Cowell