Early Success Of CBD Drug Looms Large For The Industry's Future
New Frontier Data,Benzinga 7 hours ago :
By William Sumner, Hemp Business Journal Contributor
Last week, GW Pharmaceuticals (NASDAQ: GWPH) released its financial results for the second quarter, and the results surprised analysts and investors alike. Year-over-year, the company's revenue for the quarter rose from $3.3 million to $72 million, an increase of 20.8x.
Most of that revenue came from sales of the company's flagship drug, cannabidiol (CBD)-derived Epidiolex, which reached $68.4 million for the quarter and $101.9 million for the first half of the year, destroying even the most bullish of industry predictions. In context, the Hemp Business Journal's estimate last year called for 2019 Epidiolex sales to top out at $65 million (which GW Pharmaceuticals subsequently surpassed in a single quarter).
Given those results, short-term expectations are being heightened across the industry regarding consumer appetites for CBD verticals across the space.
Since Epidiolex's launch, approximately 12,000 patients have received prescriptions for the drug, and that number is expected to increase throughout the next few years. GW Pharmaceuticals is currently conducting clinical trials of Epidiolex in the treatment of tuberous sclerosis complex (TSC) in both adult and juvenile patients.
With positive results from Phase 3 trials, the company is expected to submit a supplemental new drug application (sNDA) by the end of the year. If approved, approximately 50,000 new U.S. patients could receive Epidiolex prescriptions.
The company may also add sales channels in the European market. Having last month received a positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) GW Pharmaceuticals expects full EMA approval in October, clearing the way for Epidyolex (the European trademark) to hit European shelves in Q4-2019. With positive results for the second quarter, GW Pharmaceuticals has seen a small surge in its stock price. In the immediate aftermath of releasing its financial results, the company's stock rose approximately 11.2%, to $169.50 per share on August 8. Since then things have leveled off somewhat, with the stock's price falling back down to around $159.38, representing an overall gain of 4.5%.
The success of Epidiolex and GW Pharmaceuticals will undoubtedly help ratchet up the pressure on the U.S. Food and Drug Administration (FDA) to issue on a ruling on CBD.
With hundreds of CBD-based products already on the market, there is clear consumer demand for CBD, and with one company already making hundreds of millions from a CBD-based drug, there is a strong financial incentive to provide clarity on the issue. More FDA guidance is expected this fall.
