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Hikma Pharmaceuticals cuts 2020 guidance after delay in GSK knock-off approval

The firms received a minor complete response letter from the FDA and now has to address a “small number of questions”

Hikma Pharmaceuticals PLC - Hikma Pharmaceuticals cuts 2020 guidance after delay in GSK knock-off approval

Hikma Pharmaceuticals PLC (LON:HIK) has cut its full-year revenue guidance after delays in the approval of an asthma drug candidate developed with Vectura Group PLC (LON:VEC).

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.

READ: Hikma hiked by Goldman Sachs on 'underappreciated' generic drugs arm

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.

Quick facts: Hikma Pharmaceuticals PLC

Price: 2181.255 GBX

AIM:HIK
Market: AIM
Market Cap: £5.03 billion
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