Actelion's Opsumit growth heralds smooth switch off aging Tracleer

Actelion COO Otto Schwarz

Actelion ($ATLN) has been prepping its new pulmonary arterial hypertension (PAH) drug Opsumit to pick up the slack once the aging Tracleer goes off patent in November. And Opsumit seems poised for the job, raking in promising second-quarter numbers and prompting the company to boost its full-year guidance.

Sales for Tracleer dropped 19% in Q2 to 301 million Swiss francs from 372 Swiss francs during the same quarter last year. But sales for Opsumit, an endothelin receptor antagonist (ERA) almost tripled to 113 million Swiss francs from 38 million in Q2 2014, Actelion said in a statement. Opsumit is wooing Tracleer patients and bringing in new scripts, too, signaling big things for the PAH drug in the year to come. The company's first-half product sales rang in at 1 billion Swiss francs, a 2% jump from 993 million Swiss francs last year.

Taking the strong results into account, Actelion is upping its full year guidance and expecting earnings in the mid- to high-teen percentage range. The company previously expected full-year revenues in the low double-digit range. "We continue to be extremely pleased with the performance of Opsumit as it drives not only sales growth but also an expansion of the ERA market as a whole," Actelion's COO Otto Schwarz said in a statement.

But Actelion could face some competition for Opsumit from other PAH drugs that beat it to market, including Bayer's Adempas, which is approved to treat PAH and a second form of a rare pulmonary disorder. Gilead Sciences' ($GILD) Letairis and Pfizer's ($PFE) Revatio have also been around for years, and United Therapeutics' ($UTHR) Orenitram was approved in December 2013.

Actelion also has high hopes for its PAH candidate selexipag, touting positive results from a Phase III trial that found the drug reduced the risk of death or disease by 40% compared to placebo. Actelion has already submitted applications to the EMA and the FDA for the med, and everything is "on track" for the first marketing authorization decisions by the end of this year or in early 2016, the company said in its earnings statement.

Actelion CEO Jean-Paul Clozel

Positive Q2 results could help Actelion ward off suitors. The Swiss drugmaker is often the target of M&A speculation, with analysts citing Bayer or GlaxoSmithKline ($GSK) as potential buyers. And last month Shire ($SHPG) reportedly approached Actelion with an $18.9 billion offer, sending the company's shares to record highs.

Still, CEO Jean-Paul Clozel has long defended the company's independence, even during the tax inversion craze last summer. "Actelion--having a reasonable size, a culture of innovation and science--has the best chance to grow in a healthy way as an independent company and this benefits the shareholders," he said at the time.

But that doesn't mean the company isn't interested in making some deals of its own. Actelion CFO André Muller recently said the Swiss biotech was "actively looking" for M&A opportunities, a move that could provide extra padding once Tracleer goes off patent.

- read Actelion's earnings statement
- here's the Reuters story

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