GW Pharmaceuticals PLC- ADR (NASDAQ: GWPH) stock fell 4.68% on November 27^th, 2018 and declined over 3.3% in the November 28^th, 2018 pre market session (Source: Google finance) after the company reported a net loss, while its top line missed the expectations for the fourth quarter of FY 18. With the recent launch of Epidiolex on November 1st, GW has opened a new chapter as a commercial stage company. This launch reinforces the company’s leadership in cannabinoid science and validates the importance of cannabinoid pharmaceutical medicines that have undergone the rigor of controlled clinical trials and regulatory review. Most importantly, this launch offers patients and their families the first and only FDA-approved CBD medicine to treat too severe childhood onset epilepsy. Beyond the US, GWPH is moving into the final stages of the European regulatory review of Epidiolex, with a decision expected in Q1 2019. In parallel with this regulatory review, the company is advancing commercial launch preparations. Further, GWPH announced positive results in the second Epidiolex phase III trial in Dravet syndrome. The Epidiolex program has been transformative for GW and is going to be launched in a month. Turning now to the European regulatory process for Epidiolex, the review is progressing as anticipated and the company expect to CHMP to reach a decision on the application in the first quarter of 2019.

GWPH in the fourth quarter of FY 18 has reported the adjusted loss per share of 23 cents, beating the analysts’ estimates for the adjusted loss per share of $2.46. The company had reported the adjusted revenue of $2.42 million in the fourth quarter of FY 18, beating the analysts’ estimates for revenue of $2.45 million. Net loss for the year ended September 30, 2018 was $295.2 million compared to $170.5 million for the year ended September 30, 2017. October equity financing resulted in net proceeds of $324.2 million.

Regarding formulation enhancements, the company has developed a capsule formulation and an improved oral solution and phase I work on both these formulations is on track and taking place in 2019.

Beyond Epidiolex, Sativex represents an exciting late stage pipeline opportunity for GW. The nearest term opportunities to obtain FDA approval for Sativex is in the MS spasticity indication. Sativex is currently approved in over 25 countries outside the United States and is providing patients with relief for the symptoms and the spasticity due to multiple sclerosis, for which the company has already three positive phase III trials that are completed.