By Denise Roland 

LONDON-- GlaxoSmithKline PLC braced investors for the likely launch of a cheap copycat of its blockbuster respiratory drug Advair in the U.S., saying such competition would scuttle any profit growth in 2017.

Core earnings per share would be flat or decline slightly in 2017 if a cheap competitor to Advair entered the U.S. market in the middle of the year, the U.K.-based drugmaker said Wednesday.

Glaxo shares were down 0.3% at GBP15.58 ($19.47) on Wednesday afternoon, after falling by as much as 2.9%.

Advair lost patent protection in 2010, but the complexities of mimicking the action of an inhaled drug has delayed the arrival of generic versions. Mylan NV and Hikma Pharmaceuticals PLC are likely to launch competing products this year.

Sales of Advair are already suffering from competition but the introduction of a direct substitute would sharply accelerate that decline. Glaxo said the arrival of a generic competitor would slash U.S. Advair revenue to around GBP1 billion in 2017, compared with GBP1.8 billion in 2016.

Glaxo said that should those products fail to win approval from U.S. regulators, or be delayed, core earnings per share would increase 5%-7% at constant exchange rates.

"Clearly, this year we face some uncertainty as to the level of our earnings performance given the possibility of substitutable generic competition to Advair in the U.S.," said Chief Executive Andrew Witty.

Those alternative outlooks came as the company posted soaring profit and sales for the three months to Dec. 31, thanks to increased revenue from newer drugs and a boost from the weakness of the pound.

The company said core operating profit, a measure that strips out one-time items, climbed 52% to GBP2.1 billion, while revenue rose 21% to GBP7.6 billion. Net profit was GBP257 million, compared with a GBP354 million loss in the same period a year earlier, when restructuring costs related to Glaxo's $20 billion asset-swap deal with Novartis AG ate into earnings.

Glaxo, which reports in sterling but makes most of its revenue in other currencies, is benefiting from the weakness of the pound as politicians lay the groundwork for exiting the European Union. Stripping out the currency effect, core operating profit rose 16% and revenue increased 3%.

The company's solid performance was largely thanks to a rise in sales from its newer drugs. Glaxo said revenue from a string of medicines launched in the last few years, such as Tivicay for HIV and Advair-successor Breo, grew 71% at constant exchange rates to GBP1.4 billion of sales in the fourth quarter.

Write to Denise Roland at Denise.Roland@wsj.com

 

(END) Dow Jones Newswires

February 08, 2017 11:04 ET (16:04 GMT)

Copyright (c) 2017 Dow Jones & Company, Inc.
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