Debra Borchardt
GW Pharmaceuticals (GWPH) saw its stock slip in after-hours trading after the UK-based biotech company reported its first-quarter earnings and positive news out of Europe. First, revenue for the first quarter rose 203% to $7.7 million beating estimates by $5.4 million and topping last year’s revenue for the same period.
However, losses increased to $63.3 million or 47 million pounds, higher than last years 15.6 million pounds. The earnings per share for the quarter were -$2.44 a miss of 31 cents.
“With the Epidiolex regulatory applications accepted for review in both the US and Europe and an assigned mid-year FDA decision date, 2018 is expected to be an exciting year for our Company with an anticipated first U.S. approval and launch. The commercial teams are making great progress toward launching Epidiolex with full conviction,” stated Justin Gover, GW’s Chief Executive Officer. “We also continue to see a significant flow of clinical data from the Epidiolex program through both medical meetings such as the American Epilepsy Society and in publication including our recent Lennox-Gastaut syndrome results in The Lancet. Beyond Epidiolex, we expect to progress a number of important pipeline programs during 2018 that have the potential to offer additional value.”
The company also announced that the European Medicines Agency (EMA) has decided to accept for review a marketing application seeking approval for Epidiolex (cannabidiol) for the treatment of seizures associated with the rare forms of epilepsy called Lennox-Gastaut syndrome and Dravet syndrome. GW Pharma said that a final decision by the European Commission should be announced no later than the first quarter of next year. The U.S. NDA for the treatment of seizures associated with LGS and Dravet was accepted for priority review with the planned PDUFA goal date of June 27, 2018.
Earlier today, Cator Fitzgerald reiterated its buy rating on GW PHarmaceutical and a price target of $192. The stock has slipped from its 52-week high of $143 but has still had a huge move from its 52-week low of $92.
