Hikma Pharmaceuticals is lowering revenue guidance for its generics business due to a revised launch of its version of Advair Diskus and increased price erosion, shareholders at the annual general meeting today will be told.
The company will say: "We expect full year group revenue to be in the range of $2.0 to $2.1bn in constant currency in 2017.
"This updated guidance reflects changes in the outlook for our Generics business, where we have revised our expectation for the launch timing of our generic version of Advair Diskus and where we are experiencing increased price erosion on our marketed products.
"We maintain our full year guidance for our injectables and branded businesses.
"Generics: We announced on 11 May 2017 that the FDA had issued Hikma with 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).
"We are in the process of reviewing the response and will provide an update on our application as soon as practicable once we have completed this review and discussed it with the FDA.
"We now expect Generics revenue to be around $670 million in 2017.
"This assumes we do not launch our generic version of Advair Diskus in 2017 and reflects the intensifying competitive environment in the US.
"Through our focus on portfolio optimisation and continued cost savings, we expect to achieve a slight improvement in the profitability of the Generics business in 2017 after incurring additional operational costs related to our generic version of Advair Diskus.
"Injectables: In the year to-date, revenue from our global Injectables portfolio has been in line with 2016.
"New product launches, including the former Bedford products, are enabling us to offset the impact of increased competition on certain products.
"We continue to expect global Injectables revenue to be in the range of $800 million to $825 million for the full year, with core operating margin in the high 30s, reflecting a further step-up in R&D.
"Branded: We are reiterating our expectation for Branded revenue growth in the mid-single digits in constant currency in 2017.
"As in previous years, we expect the usual seasonality of the Branded business and our pipeline of new product launches in key markets to drive stronger revenue in the second half of the year.
"On a reported basis, we continue to expect Branded revenue to grow in the low-single digits in 2017 and core operating margin to be broadly in line with 2016.
"This reflects an adverse currency impact, primarily arising from the devaluation of the Egyptian pound against the US dollar by approximately 51%."