GW Pharmaceuticals PLC- ADR(NASDAQ: GWPH) stock enhanced over 6.6% on December 7th, 2017 after facing pressure in the last three days on the back of its lower than expected performance.
Their revenue for the quarter rose only $0.7 million to $2.9 million in the fourth quarter of 2017 as compared to $2.2 million in the fourth quarter of 2016. For the full year, revenue reached $11 million from $13.8 million in pcp, lower than forecasts. These expectations fall is hurt by falling R&D fee recharges following the end of apartment funded Sativex cancer pain studies during the 2016 financial year.
The group finished its Epidiolex NDA submission to the FDA and expecting their decision by the end of the month regarding. The group forecasts to get confirmation of an expedited review of the NDA and this would lead to an expected PDUFA date in mid-2018.
The group is scaling up in the manufacture, making major progress in preparations for the potential U.S. launch of Epidiolex and started building a European commercial presence.
Going forward, their forecast 2018 to be a transformational year wherein they are planning for the potential approval and launch of Epidiolex in the United States.
Apart from U.S., they are making plans for centralized European regulatory submission, which is expected to by this year-end. Phase 3 trials included European sites and this application heavily draws on the content of the NDAs submitted to the FDA. The European regulatory process is would to take more than one year leading to an expected first quarter 2019 decision point. The group is adding relationships with the major epilepsy centers in the United States.
The group’s Net cash outflow from operating activities for the ended September 30, 2017, reached $147.3 million from $113 million in pcp due to rises in R&D expenditure and pre-launch costs. GWPH has a cash equivalent to $322.2 million.
The group forecasts spending to continue at a similar rate for the first six months of the fiscal year 2018 and accordingly expects total cash outflows for the first half of the year in the range of 75 million to 95 million pound sterling or $100 million to $120 million based on today’s prevailing currency exchange rates. If Epidiolex is approved, they see cash outflows to rise in preparation for product launch.