The UK-based GW Pharmaceuticals (Nasdaq: GWPH) is set to report its fourth quarter and fiscal 2018-end results for the period ending September 30, 2018, on Tuesday after the bell. After the biopharma company announced positive results on Monday from the second trial of Phase 3 study of Epidiolex, a treatment for epilepsy that is derived from cannabis, the stock was trading in green throughout the day.
The consensus estimates GW to post a loss of $2.48 per share for its just concluded quarter. In the same quarter last year, the company posted a loss of $0.18 per share on revenue of $2.86 million. For the third quarter ended June 30, the British biopharma posted a loss of $1.26 per share on revenue of $3.5 million, which beat the analysts’ views.
In June 2018, GW’s cannabinoid-based Epidiolex received USFDA approval and the company has submitted a marketing authorization application to the European Medicines Agency and expects the decision in Q1 2019. Early in November, the marijuana-based drug was made available in the US by physician prescription.
In September, the U.S. Drug Enforcement Administration (DEA) transferred Epidiolex to Schedule V, the lowest restriction classification. Justin Grover, GW’s CEO commented that this decision will help ensure that patients with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two of the most debilitating forms of epilepsy, can get this new treatment option through their physicians. With this decision, the product label for Epidiolex will be finalized.
Also, GW has commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex, which is approved for the treatment of spasticity due to multiple sclerosis outside the US. The company is now planning a US Phase 3 trial for Sativex.
With the positive results announced today, all eyes will be eagerly watching on the company’s plans to bring out its cannabis-based Epidiolex to the market.
It’s worth noting that GW’s competitor Canada-based cannabis-based drug company FSD Pharma appointed GW’s former marketing chief Rupert Haynes as its CEO on Monday to establish a foothold in the CBD market.
Shares of GWPH pared its early gains and ended Monday’s trading session at $127.70, up 2.94%. The stock didn’t deviate much in the past one year. However, it dropped 3% from the beginning of this year.