(Image Credit - Nick Youngson)
After the close of trading on Monday, August 7th, GW Pharmaceuticals Plc (NASDAQ:GWPH) reported the company's financial results for their fiscal third quarter and hosted a conference call to discuss the results. Here are 8 things (not in any particular order) that current and prospective investors in GW Pharmaceuticals should take away from the company's recent earnings release:
At the end of the third quarter (June 30th) of 2017, GW Pharmaceuticals had £284.1 million ($369.5 million) in cash and cash equivalents.
GW Pharmaceuticals brought in £6.1 million ($7.9 million) of revenue in the nine months ended June 30, 2017. This marked a 29% decrease in revenues compared to the comparable period of 2016.
The company reported a net loss of £90.3 million ($117.5 million) in the nine months ended June 30, 2017 compared to a loss of £46.7 million for the nine months ended June 30, 2016. Unfavorable changes in exchange rates were a contributing factor to the company's higher net loss.
GW Pharmaceuticals is underway with a rolling New Drug Application (NDA) for Epidolex (a naturally-derived CBD treatment that GWPH is seeking FDA approval for the treatment of two orphan epilepsy conditions). They expect the final sections of the submission to be completed in October.
The company is scaling up their manufacturing in preparation for commercialization and preparations are on track for an FDA GMP (good manufacturing practices) inspection. The inspection is anticipated to take place in early 2018.
GW is planning to submit an application for the approval of Epidolex to the European Medicines Agency (EMA) in the fourth quarter of 2017. The company has already held pre-submission meetings with the EMA.
GW is also underway with phase 3 trials of Epidolex for the treatment of two additional orphan epilepsy conditions; infantile spasms and tuberous sclerosis.
In terms of their cannabinoid pipeline beyond Epidolex, GWPH has presented positive survival data from their phase two study of CBD:THC in Glioblastoma, is conducting multiple studies of cannabidivarin (CBDV) in the areas of both epilepsy and autism spectrum disorders and has completed a phase one clinical trial of intravenous CBD for the treatment of Neonatal Hypoxic-Ischemic Encephalopathy (they have received both an Orphan Drug Designation and a FDA Fast Track Designation for this project).
In after-hours trading on August 7th, shares of GW Pharmaceuticals are falling roughly 2.5% after recovering some of their initial losses during the conference call. Year to date, shares of GWPH are roughly flat.
Be sure to check out GW Pharma's marijuana stock profile to learn more and view a custom stock chart.
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