Jack Smith
GW Pharmaceuticals (NASDAQ: GWPH) reported mixed second-quarter results on Tuesday after the market close, as revenue came in ahead of consensus but earnings expectations missed the mark by a wide margin.
U.K.-based GW Pharmaceuticals said it lost $3.12 a share on $3.35 million in sales, though the company mentioned the positive outcome of the Epidioled FDA Advisory Committee meeting during the quarter as one of the highlights.
GW’s CEO Justin Gover said that the company’s clinical data demonstrate a bright future for the company.
“The strength and consistency of the clinical data, together with the public presentations that featured very moving personal stories of the challenges associated with managing these difficult forms of epilepsy, led to a unanimous vote in support of approval,” Gover said in a statement. “With our late June FDA decision date nearing, our commercial team is busy preparing to launch Epidiolex in the second half of this year.”
Analysts compiled by Seeking Alpha expected the company to lose $2.48 a share on $3.03 million in revenue during the quarter.
Shares were falling 0.9 percent in after-hours trading to $143.25.
Epidiolex is the company’s pending drug for a number of health issues, including Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS).
Gover noted that if Epidiolex is approved, it would be a huge boon for the company’s cannabinoid platform.
“Should Epidiolex be approved, we believe that this will signal a major vote of confidence in GW’s cannabinoid platform to discover and develop prescription medicines that meet exacting regulatory standards and will serve us to accelerate a number of important pipeline programs that have the potential to offer additional value,” he added.
GW, with a market cap approaching $4 billion, is one of the largest pure-play publicly traded cannabis companies. The company said it ended the quarter with $487.2 million in cash.
The company describes itself as “a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform.”
In addition to the financial results, GW said it had submitted Eipidiolex to the European Medicines Agency during the quarter and expects a decision in the first quarter of 2019.
It also received pre-approval from the DA for its cGMP inspection and did not receive any 483 citations. GW also submitted the second Phase 3 LGS trial for publication, with a paper expected to be released “shortly.” The phase 3 trial for the Tuberous Sclerosis Complex is expected to have data in the first half of 2019.
Shares of GW have bucked the broader downturn in cannabis-related equities in recent months. The Green Market Report Cannabis Company Index fell 21.9 percent in the first quarter, as regulatory concerns, especially in the U.S., weighed on investors’ minds.
GW shares have gained roughly 8 percent since the start of the year and more than 35 percent over the past year, outpacing the gain seen in the broader NASDAQ and S&P 500.
