GW Pharmaceuticals plc (Nasdaq: GWPH) stock was down about 4% in the extended hours of trading after the company missed analyst estimates for the fourth quarter.
Sales for the biopharma firm came in at $2.42 million, which dipped modestly by 1% over last year. The dip in revenues was due to flat product sales compared to the prior year period. Fourth quarter revenues failed to beat street consensus.
The company’s loss increased 28% to $0.23 per share compared to $0.18 loss per share reported in the prior year period. The double-digit jump in the loss was due to increased selling, general and administrative (SG&A) expenses. GW reported $52.7 million as SG&A expenses in the fourth quarter, which has more than doubled from $19.4 million reported last year.
On November 26, GW’s frontline cannabinoid drug Epidiolex reported 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 the childhood. On November 1st, the drug was available in the US by physician prescription. It is estimated that there are 2.2 million people in the US who suffer from epilepsy and nearly 470,000 are children.
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It’s worth noting that Epidiolex was approved by the US FDA in June 2018 to treat patients who are suffering from seizures relating to Dravet syndrome or Lennox-Gastaut syndrome (LGS). The company filed a marketing authorization application with 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 the 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.
GW’s share is marginally down about 3% in 2018, while the biopharma stock has lost more than 7% in the last 12 months.