Mylan Trims Forecast Due to FDA Approval Delays

12.08.2014 -

US generic drugmaker Mylan has shaved the top end of its full-year revenue and earnings forecasts slightly, citing delays in approval from the US Food and Drug Administration for key generic drugs that it plans to launch this year.

Despite the delays, however, Mylan said it planned to launch a generic version of Teva's multiple sclerosis treatment, Copaxone, in the fourth quarter of this year.

Also in the fourth quarter, the company plans to launch a generic version of Pfizer's blockbuster Celebrex, an anti-inflammatory treatment for arthritis.

Given the anticipated launches of key products, the fourth quarter is expected to be the strongest quarter of the year, Mylan said in a statement.

However, it said "ongoing delays in approvals of key products" had burdened its earnings in the second quarter.

Mylan's newest forecast calls for full-year 2014 revenue in a range of $7.8 billion to $8 billion and earnings of $3.25-$3.45 per share, including the fourth-quarter launch of generic Copaxone and Celebrex.

It had earlier forecast full-year revenue of $7.8 billion to $8.2 billion and earnings of $3.25-$3.60 per share.

Analysts on average expect full-year 2014 earnings of $3.37 per share on sales of $7.7 billion.

Mylan said its acquisition of Abbott Laboratories' branded specialty and generics business in developed markets outside the US could help it reach its 2018 earnings target ahead of schedule.

The $5.3 billion deal, announced in July, will bolster the company's product line and cut its tax bill.