By William Sumner, Hemp Business Journal Contributor
As the U.S. Food and Drug Administration (FDA) continues to consider how to regulate cannabidiol ( CBD), the one company with the green light to sell CBD as a pharmaceutical drug is raking in profits.
This month, the London-based pharmaceutical company GW Pharmaceuticals (NASDAQ: GWPH) released its financial results for the first quarter of 2019.
Smashing expectations and projections, GW generated $33.5 million in net sales, up considerably from the $3 million of revenue generated in Q1-2018. For greater context, the Hemp Business Journal estimated that the company would make approximately $65 million in sales for the entirety of 2019; should sales continue at current pace, GW will easily exceed those projections by the end of Q2-2019.
Since Epidiolex was launched, approximately 7,600 patients have received it, according to the company. Roughly 90% of those patients had their medications covered by health insurance, with 65% of them having prior authorization for coverage.
GW also reported positive results from a Phase 3 trial for Epidiolex in treating seizures associated with Tuberous Sclerosis Complex (TSC). In the trial, patients suffering from TSC were given either a 25-milligram- or 50-mg-per kilogram dose of Epidiolex once a day. Patients given the lower dosage experienced a seizure reduction rate of 48.6%, while patients given the higher dosage combined for a 47.5% reduction, with patients given a placebo experiencing a 26.5% reduction.
“The positive outcome in this trial of Epidiolex in patients with Tuberous Sclerosis Complex expands both our knowledge of this newly available medicine and its potential utility beyond the current indications,” said Elizabeth Thiele, M.D., Ph.D., director of the Herscot Center for Tuberous Sclerosis Complex at Massachusetts General Hospital, professor of neurology at Harvard Medical School, and lead investigator of the trial. “Based on the positive results of this trial in TSC patients, Epidiolex, if approved for this additional indication, may become an important treatment option also in this disease state with significant unmet medical need.”
By the end of Q4-2019, GW plans to submit a supplemental application to the FDA for the drug’s use in the treatment of TSC. If approved, sales of Epidiolex could climb yet. Investors reacted strongly to the news of the company’s positive financial and clinical results: Over the past quarter, shares of GW rose 21.6%, and in the last year they increased by roughly 16.49%. Meanwhile, the S&P 500 has increased by 3.54% in the previous quarter, and 7.23% through the last year.
The Hemp Business Journal estimates that by 2022 pharmaceutical-based CBD sales will reach $360 million. However, given the unexpected success of Epidiolex, and the aggressive growth of the hemp-based CBD market, those numbers may exceed the current projection. Look for the Hemp Business Journal to revisit and revise its CBD forecasts over the coming months.
William Sumner is a writer for the hemp and cannabis industry. Hailing from Panama City, Florida, William covers various topics such as hemp legislation, investment, and business. William’s writing has appeared in publications such as Green Market Report, Civilized, and MJINews. You can follow William on Twitter: @W_Sumner.