Tag: Hikma

August 17, 2017 Off

Hikma reduces net debt for $64M in 1H, revenue 1% up

By Dino Mustafić

During H1 2017, the Generics business launched 7 products, including all dosage forms and strengths, and received 14 product approvals.

We announced on 11 May 2017 that the US Food and Drug Administration (FDA) had issued a complete response letter (CRL) in relation to our abbreviated new drug application (ANDA) for our generic version of GlaxoSmithKline’s Advair Diskus® (fluticasone propionate and salmeterol inhalation powder). Since then we, supported by our partner Vectura, have had constructive discussions with the FDA and we have been able to clarify and resolve a number of the questions raised. The discussions with the FDA have confirmed our initial assessment that there are no material issues regarding the substitutability of the proposed device. We are in ongoing discussions with the FDA to address the remaining questions and will provide a more detailed update to the market as soon as we are able to do so.

We now expect Generics revenue to be around $620 million for the full year, reflecting the impact of increased competition on prices and volumes. Through our focus on portfolio optimisation and continued cost savings, we expect the Generics business to achieve core operating profit of around $30 million in 2017.