GW Pharmaceuticals shows operational progress as the company reports financial results.
GW Pharmaceuticals plc (NYSE: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces financial results for the first quarter ended March 31, 2020.
In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year.Justin Gover, GW's CEO
"Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August," stated Justin Gover, GW's CEO. "In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science."
- Total revenue for the quarter ended March 31, 2020, was $120.6 million compared to $39.2 million for the quarter ended March 31, 2019
- Net loss for the quarter ended March 31, 2020, was $8.0 million compared to a net loss of $50.1 million for the quarter ended March 31, 2019
- Cash and cash equivalents at March 31, 2020, were $500.9 million compared to $536.9 million as of December 31, 2019
Epidiolex (cannabidiol) progress:
- Total Q1 net product sales of Epidiolex of $116.1 million
- U.S. commercial update
- U.S. Epidiolex Q1 net product sales of $106.1 million
- August commercial launch planned for TSC indication; July 31 PDUFA date
- Epidiolex descheduled by the DEA
- Payer discussions focused on pending TSC approval and expanding coverage
- European commercial update
- Successful commercial launches in Germany and the UK
- Important pricing & reimbursement progress in Germany & Italy. Commercial launches in France, Spain and Italy on track for later this year
- TSC EMA submission accepted for review
- Clinical progress with additional indications to broaden the addressable market
- Phase 3 trial in Rett Syndrome (recruitment temporarily on hold)
- Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution and capsule
- Strengthening commercial exclusivity
- Orphan exclusivity in both the U.S. and EU
- 10 granted patents listed in Orange Book with expiry dates to 2035, including 1 patent recently granted broadly covering use in LGS and Dravet syndrome
- Epidiolex composition patent application in process
- 1 new allowed patent covering seizure sub-type use in Dravet syndrome expected to grant in Q2 2020
- TSC patent applications under review with initial grant expected in 2020.
- Start of new clinical programs delayed until H2 2020 due to current COVID restrictions
- Nabiximols (Sativex® outside of the US)
- Multiple Sclerosis spasticity
- US pivotal clinical program expected to commence in H2 2020 to augment existing data package
- 3 positive Phase 3 trials completed in Europe
- Spinal cord injury spasticity – clinical program expected to commence in H2 2020
- PTSD – clinical program expected to commence in H2 2020
- Schizophrenia (GWP42003)
- Phase 2b trial expected to commence H2 2020
- CBDV in autism
- 30-patient open-label study in autism
- Investigator-led 100 patient placebo-controlled trial in autism
- Open-label study in Rett syndrome and seizures
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commenced
- Phase 1b safety study in patients continues to recruit due to the emergency care environment
- Orphan Drug and Fast Track Designations granted from FDA and EMA
To learn more about GW Pharmaceuticals, visit the company HQ here.
Disclaimer: Past performance is not an indicator of future performance.
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