Q3 financial results – Operational Highlights
GW Pharmaceuticals (GWPH) released third quarter financial results for the period that ended on June 30th.
- FDA approval for the treatment of seizures associated with LGS or Dravet syndrome
- Epidiolex rescheduling expected within 90 days of FDA approval
- European submission under review by the EMA with decision expected in Q1 2019
- Commercial product being manufactured and prepared for shipping to the U.S.
- Continued investment in expanded facilities to meet anticipated long-term demand
- U.S. sales organisation fully recruited comprising two national directors, eight regional managers plus 66 Neurology Account Managers
- Active engagement with U.S. payors ongoing with clinical presentations to plans that cover over 80% of covered lives in the U.S.
- U.S. supply chain platform in place which will employ a closed model distribution network of five SpecialtyPharmacy Providers (SPP’s)
- Commercial footprint in place in 5 major European markets in readiness for 2019 European launches
Epilepsy Clinical trials
- Three Phase 3 clinical trials published – two in The New England Journal of Medicine and one in The Lancet
- Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019
- Decision to expand target indications for Epidiolex beyond epilepsy to autism. IND expected to be submitted for pivotal Rett Syndrome study in Q4 18.
- Expanded access program and open-label extension: * Over 2,000 patients now have been exposed to Epidiolex treatment
- 7-year orphan exclusivity confirmed by FDA, 6-month paediatric extension expected
- Key favourable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam * Patents align directly with new Epidiolex FDA label and to be listed in Orange Book
- Patent expiry dates to 2035
- Additional patent applications under review and being filed as new data is generated
- Pipeline progress
- U.S. development and commercialisation rights wholly owned by GW
- Initial U.S. target indication: Multiple Sclerosis spasticity. Three positive Phase 3 trials completed in Europe
- Plans to meet with FDA in H2 18 to determine MS spasticity regulatory pathway in the U.S.
- Over 20 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
- As of June 30th, GW had $440.2 million of cash and cash equivalents
- During the nine months that ended on June 30th, GW recorded a $180.2 million net loss on $14.2 million in revenue
So GW Pharmaceuticals becomes the first company to develop a cannabis-based drug that is approved by the FDA. A real milestone for the company, the industry and the global revolution that is medicinal marijuana. However, their stock price has been in a decline since. So the question begs – why is this?
The simple answer. There isn’t one. There is no logical reason for this. It could simply be – once again – a case of investors buying the rumours and selling the news. There is no other reason for the significant decline seems since the announcement (~20% down from the $165 high) but there is still the (impending) DEA approval of the drug (given it is still a Schedule One drug) and this could turbo boost the stock price again. We continue to hold GW Pharmaceutical and are very bullish for its future. It could be an acquisition target for a larger pharmaceutical player looking to gain entry to the market, and of course, with a significant pipeline of IP and commercial products, the future remains very bright for the undisputed market leader in the medicinal cannabis industry.