In fiscal 2018, GW Pharmaceuticals (GWPH) reported net income and EPS of -$295.2 million and -$0.88, respectively, compared to -$170.5 million and -$0.56 in the prior year. In the fourth quarter of 2018, GW Pharmaceuticals reported net income and EPS of -$79.9 million and -$0.23, respectively, compared to -$53.9 million and -$0.18 in the same period the prior year.
In fiscal 2018, GW Pharmaceuticals (GWPH) reported cost of product sales of $6.0 million compared to $4.5 million in fiscal 2017. In fiscal 2018, the company’s R&D (research and development) and SG&A (selling, general, and administrative) expenses amounted to $153.7 million and $141.8 million, respectively, compared to $112.2 million and $58.0 million in fiscal 2017.
GW Pharmaceuticals’ Epidiolex demonstrated a positive result and achieved the primary endpoint in a phase 3 clinical trial that evaluated the efficacy parameters of the drug for the treatment of Dravet syndrome. In the clinical trial, both the doses of Epidiolex (10 mg/kg/day and 20 mg/kg/day) demonstrated statistically significant improvements in the secondary endpoint parameters compared to a placebo therapy.
GW Pharmaceuticals also completed patient recruitment for its phase 3 trial of Epidiolex for the evaluation of its safety and efficacy parameters for the treatment of individuals with Tuberous Sclerosis Complex. The company anticipates data from the clinical trial in the first half of 2019 and expects submission of a supplemental new drug application (or sNDA) to the FDA (Food and Drug Administration) in the second half of 2019.
The label expansion of Epidiolex could significantly boost the sales growth of the drug.