Debra Borchardt
British biotech firm GW Pharmaceuticals pls (NASDAQ: GWPH) second-quarter net sales of $68.4 million of the company’s cannabis-related drug Epidiolex, which is prescribed for children with rare epilepsy diseases. For the first half of 2019, GW Pharmaceuticals has sold $109 million of the drug. The good news sent the stock higher by over 10% in aftermarket trading to lately trade near $170.
“We are pleased to report a strong second quarter of sales of Epidiolex in the US, reflecting high demand by US patients, increased prescribing by healthcare providers, and ongoing progress in payor coverage determinations. With the recent positive Phase 3 trial in Tuberous Sclerosis Complex, we expect to submit an sNDA by the end of 2019 with the goal of expanding the Epidiolex label and market opportunity to include both children and adult patients with TSC, a highly treatment-resistant condition,” stated Justin Gover, GW’s Chief Executive Officer. “In Europe, we are pleased to have recently received the positive opinion from the CHMP which clears the way for an expected approval in October. Our European commercial organization is in place and will be ready to launch in the first European markets upon approval, making this important new treatment option available to deserving European patients.”
The company delivered $72.0 million in revenue for the quarter ending June 30, 2019 versus $3.3 million for last year’s quarter for the same time period. Net income for the quarter was $79.7 million versus a net loss of $84.0 million for last year’s quarter. The cash and cash equivalents on June 30, 2019, were $583.7 million.
GW Pharma also reported that over 12,000 patients have received Epidiolex prescriptions since launch and over 2,500 physicians have generated dispensed prescriptions. It is taking approximately two weeks for pharmacies to fill the prescription for a first time user. The company also said that the vast majority of patients who have received Epdiolex remain on therapy and that 900 patients had transitioned in expanded access programs. 93% of the patients had insurance coverage.
The company said that they expect fourth-quarter launches in France, Germany, and the UK for Epidiolex. Spain and Italy launches will follow in 2020. The Early Access Program in Europe for Dravet syndrome and LGS patients now includes over 800 patients registered across 5 major EU countries.
