GW Pharmaceuticals Says 2018 ‘A Pivotal Year’

London-based biotech company GW Pharmaceuticals (GWPH) reported its fourth quarter and fiscal year-end results with revenues dipping and losses rising as the company gets closer to launching its Epidiolex drug in the U.S.

GW Pharmaceuticals delivered revenue of $11 million or 8.2 million in sterling pounds for the year ending September 30. This was lower than last year’s $13.9 million or 10.3 million in pounds. The loss for the year was reported at $175 million or 131 million pounds, much higher than last year’s $85 million or 63 million in pounds. The loss per share was 58 cents or 0.43 in pounds, also higher than last year’s loss of 32 cents or 0.24 in pounds. The exchange is based on today’s approximate rate equivalent. The company’s success hinges on its ability to commercialize Sativex and Epidiolex if approved by the FDA.

“With the Epidiolex NDA for Dravet syndrome and Lennox-Gastaut syndrome submitted, we have entered a very exciting period for GW and look forward to working with the FDA to support its review process. With a decision on the NDA anticipated in mid-2018, we believe we are making excellent progress with preparations to ensure a highly successful US launch if Epidiolex is approved,” stated Justin Gover, GW’s Chief Executive Officer. “We also expect to submit a European regulatory application for Epidiolex for these indications in late 2017 and are now building a European commercial presence to prepare for a potential future launch. During 2017, a substantial body of positive clinical data on Epidiolex was published and presented, including a landmark publication in The New England Journal of Medicine, as well as a wide range of important data presentations and posters at the American Academy of Neurology and American Epilepsy Society annual meetings.”

GW Pharmaceuticals Risks

The company is dependent upon receiving FDA approval for its drugs in the U.S. and then the adoption by physicians and patients and reimbursement by insurance companies. The company said in its filing, “Even if completed Phase 3 clinical trials and/or ongoing or future Phase 3 clinical trials conducted for regulatory approval show positive results, there can be no assurance that the FDA, EMA or any other regulatory authority will approve Epidiolex or any other product candidate for any indication for several potential reasons.”

GW Pharmaceuticals also mentioned that competition is heating up in the space and noted that Insys Therapeutics and Zogenix had both announced plans to develop similar drugs.

Company Addresses Spending Levels

2018 will be a make it or break it year for the company. The company admitted it has consumed a lot of cash since inception and noted that 2018 will be a pivotal year. In the company’s filing it stated, “We expect spending to continue at current levels and anticipate total cash outflows for the first half of the year ended September 30, 2018, in the range of $100 million to $120 million (£75 million to £90 million), which includes capital expenditure of $10 million to $20 million related to manufacturing expansion. Thereafter, following NDA approval, we expect cash outflows to increase in preparation for product launch.”

GW Pharmaceutical Pipeline

• The company has a deep pipeline including cannabidivarin, or CBDV, which is in Phase 2 development in the field of epilepsy and is also being researched within the field of autism spectrum disorders, or ASD. I
• Received Orphan Drug Designation and Fast Track Designation from the FDA for intravenous CBD for the treatment of Neonatal Hypoxic-Ischemic Encepholapthy, or NHIE, for which a Phase 1 safety study has now been completed.
• Sativex for MS spasticity – approved in numerous countries.
• CBD and THC combination for Glioblastoma – Phase 2 trial complete with an open IND for clinical program
• GWP42003 for schizophrenia had a positive Phase 2 proff0of-concept and next steps are under consideration.

Stock Price

The stock is up over 3% on the earnings report and was lately trading at $128, down from the company’s 52-week high of $136. The stock has recovered from its summer slide where it dipped into the mid $90’s.