GW Pharma is expected to post a quarterly loss of $2.97 per share, indicating a 22% slide from same time a year ago, on revenue of $7.10 million. However, this could see a change given that the company is shifting its earnings reporting to a new fiscal year-ending Dec. 31, 2018.
LOOKING BACK
In the previously reported fourth quarter of the last fiscal cycle, GW Pharma stock slipped 4% in after-hours trading after the company missed analyst estimates for the period. Sales for the biopharma firm dipped 1% to $2.42 million on flat product sales, and revenues failed to beat street consensus.
The company’s loss widened 28% to $0.23 per share, on increased selling, general and administrative (SG&A) expenses.
On Nov. 26, GW’s frontline cannabinoid drug Epidiolex posted positive results in the second Phase-3 trial for treating patients diagnosed with the Dravet syndrome, a rare form of epilepsy which causes seizures right from childhood. It is estimated that there are 2.2 million people in the US who suffer from epilepsy and nearly 470,000 are children.
Epidiolex was approved by the US FDA in June 2018 to treat patients suffering from seizures relating to Dravet syndrome or Lennox-Gastaut syndrome (LGS). The company filed a marketing authorization application with the European Medicines Agency (EMA) and expects to receive approval from the regulator by the first quarter of 2019.
Epidiolex competes with Fintepla from Zogenix (ZGNX). Fintepla is a low-dose fenfluramine formulation drug to treat patients with Dravet syndrome. Zogenix has kickstarted the rolling submission of new drug application filing to FDA for treating patients with the Dravet syndrome. The low-dose fenfluramine drug has also shown positive results in LGS with Zogenix is currently enrolling patients for phase 3 clinical trial of Fintepla for patients diagnosed with LGS.