Consort Medical PLC (LON:CSRT) has warned it will take a £3mln hit this year from delays with Mylan’s (NASDAQ:MYL) Wixela inhaler, the generic version of GlaxoSmithKline PLC’s (LON:GSK) Advair chronic lung disease treatment.
US regulators shot down Wixela for a second time in June, after which Mylan bosses said they hoped to gain approval for the device by mid-October. A week into December, and the green light is still yet to be seen.
Consort is making the inhaler itself, while its Mylan’s job to devise the formula for the drug.
“Due to the delay with Mylan in their Wixela (generic Advair) programme, the board expects profit before tax for the current financial year to be adversely impacted by approximately £3mln as compared to their previous forecast,” said chief executive Jonathan Glenn.
“Whilst the delay in approval of this programme and near-term anticipated negative impact on our business is disappointing, our view of the peak sales opportunity for the product remains unchanged.”
That message didn’t quite chime with what analysts had previously said, with Wells Fargo claiming back in October that the delays meant the opportunity was “rapidly diminishing”.
The news came alongside Consort’s interim results, which showed a slight drop in revenue to £152.5mln in the soc months ended October 31 (H1 17: £153.7mln).
Adjusted pre-tax profits rose 6% though to £19.0mln (H1 17: £17.9mln), reflecting a lower pension charge and tax rate. The company nudged its interim dividend up 2.2% to 7.60p.
Shares fell 20.5% to 780p on Tuesday.