Hikma expects revenue in the generics business to be US$710-730mln with core operating margin of 18-19% compared to US$720-760mln with 21% core operating margin that was announced in August.
The FTSE 100 drug manufacturer expected the generic version of Advair Diskus, GlaxoSmithKline PLC’s (LON:GSK) top-selling asthma treatment, to be approved by the US Food and Drug Administration (FDA) in the second half of this year but it is now postponed to early 2021.
Hikma has received a minor complete response letter from the FDA and now has to address a “small number of questions” as part of the approval process.
Once answered, the FDA should respond in 90 days.
Shares in Hikma dropped 4% to 2,475p while partner Vectura was up 1% to 116.6p on Tuesday at the opening bell.