Intro & History:
GWPH, GW Pharmaceuticals (NASDAQ: GWPH) is a British biopharmaceutical company known for its multiple sclerosis treatment product Sativex, and Epidiolex (cannabidiol) which is their lead development drug nearing market introduction to treat a rare form of childhood-onset epilepsy which currently has few, if any, real treatment options. Sativex was the first natural cannabis plant derivative to gain market approval in any country. Founded in 1998 and based in Salisbury, UK GWPH is headed by Geoffrey W. Guy and Brian Whittle. GWPH calls themselves the “global leader in developing cannabinoid-based medicines.” We think that the epilepsy market is a sweet spot for cannabinoids because of relaxing medical marijuana regulations and the increasing prevalence of various types of epilepsy, all over the world.
Recent News & Developments:
On May 24th of this year, GWPH through its subsidiary Greenwich Biosciences published a “groundbreaking” study of Epidiolex in the prestigious New England Journal of Medicine. This corresponded with a slight surge in stock price, but came nowhere near historical highs. In any case, the current Phase III study has received ample positive attention not only in the NEJoM but from physicians specializing in conditions it is designed to treat at the American Academy of Neurology annual meeting on April 25 of this year.
This is starting to sound repetitive, but we have to say again that with relaxation of regulations at the state level, the federal government will eventually have to follow suit. So far that has remained elusive, especially with notorious drug warrior Jeff Sessions, the current U.S. Attorney General pressing Congress for the repeal of the Rohrabacher-Farr Amendment which prevents the federal government from prosecuting (or persecuting) marijuana based businesses that are in compliance with their state and local laws.
In some good news to counter the bad, Cory Booker, a liberal Democrat from New Jersey; Kirsten Gillibrand, a more moderate Democrat from New York; and Rand Paul, a libertarian leaning Republican from Kentucky introduced the CARERS Act which directly benefits firms like GW Pharmaceuticals by officially codifying Obama era policies whereby the feds largely ignored medical marijuana based businesses, and expanding opportunities for medical and scientific research into therapeutic uses for cannabinoids through a combination of banking, veterans access, and perhaps most importantly rescheduling marijuana away from the Schedule I designation which it shares with Heroin and LSD, making it very cumbersome to perform research. Finally, this act would completely remove cannabidiol (CBD), GWPH’s bread and butter so to speak, from federal drug schedules.
GWPH’s pipeline includes CBDV (GWP42006) for epilepsy and autism spectrum disorders and a host of other similarly cannabis-derived compounds for conditions including a form of neonatal encephalopathy, glioma, schizophrenia and complications stemming from multiple sclerosis. There are numerous clinical trial actions underway, viewable at the Clinicaltrials.gov website here.
Market Data & Performance:
Currently at $103.49 with a Market Cap of $2.61B. This is down from their all-time high of $132.73 in September of 2016 that coincided with the end of that fiscal quarter, the impending filing for FDA approval of Epidiolex (which still has yet to occur), and a resulting sharp spike of $50 in share price from August 1 to September 1, 2016. Since that time performance has been mostly negative, but could be looking up for Q3 2017.
Various positive indicators came out of the Q2 2017 call in early May. These included improving assets to liabilities and assets to inventory ratios. They’ve budgeted a significant $130M-$150M to spend for the next 12 month period, largely on operations, research and market penetration. They also discussed high profile Phase III research and development news regarding Epidiolex – which may finally be nearing FDA approval, several management changes including the hire of Scott Giacobello as their new CFO and plans to become a U.S. domestic NASDAQ registrant reporting under U.S. GAAP (and in U.S. dollars) in the near future, among other items.
Conclusion & Looking Ahead:
Based on current and historical performance, as well as positioning of current and future drug releases, GWPH is probably a bit undervalued. Sales of legal cannabis and marijuana in both the recreational and medical sectors are expected to rise by ~30% in 2017, ~45% in 2018, and reach $17 billion (or more) in 2021, per the “Marijuana Business Factbook 2017”. Numerous cannabis related stocks have already surpassed 2X or 3X on their value at introduction/IPO and GW is sitting at a pretty low point right now.
We think you are capable of doing the math here. While I cannot make any specific recommendations on this stock, you will be well served to short list a group of marijuana based stocks and follow them closely in the coming months and years. This should be one of them – keep an eye on upcoming clinical trials because the FDA and EMA processes to bring new drugs to market is long and fraught with peril and the floor can drop out at any time as a result. You should also be wary of a “green rush” bubble propping up marijuana based stocks but also understand that the inherent safety of cannabinoid products and derivatives, along with the aforementioned relaxed federal medical cannabis regulatory environment, do provide some insulation from sudden stock crashes resulting from suits or government “imminent public safety” action.
Finally, the status quo in Washington D.C. could be good for firms with existing research capabilities and market penetration like GW. Namely, recreational use is facing a steep climb toward federal legality, but numerous pieces of legislation currently making their way through Congress with the aim of easing restrictions on all aspects of the medical marijuana business.