Total revenue increased 68 per cent to $121.3 million.
GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced financial results and operating progress for the second quarter ended June 30, 2020.
We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year.Justin Gover, GW's CEO
"We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond," stated Justin Gover, GW's CEO. "We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions."
- Total revenue for the quarter ended June 30, 2020 was $121.3 million compared to $72.0 million for the quarter ended June 30, 2019
- Net loss for the quarter ended June 30, 2020 was $8.8 million compared to net income of $79.7 million for the quarter ended June 30, 2019. The prior year quarter included net proceeds of $104.1 million from the sale of a Rare Pediatric Priority Review Voucher.
- Cash and cash equivalents at June 30, 2020 were $477.6 million
- Epidiolex (cannabidiol) progress:
- Total Q2 net product sales of Epidiolex of $117.7 million
- U.S. commercial update
- U.S. Epidiolex Q2 net product sales of $111.1 million
- TSC indication approved by FDA, August commercial launch planned
- TSC payer reimbursement anticipated quickly following launch
- European commercial update
- Ex-U.S. Epidyolex Q2 net product sales of $6.6 million
- Pricing & reimbursement progress in Germany, France and Italy
- TSC EMA submission under review
- Clinical progress with additional indications
- Phase 3 trial in Rett Syndrome expected to re-commence in H2 2020
- Strengthening commercial exclusivity
- Orphan exclusivity in both the U.S. and EU
- 3 new patents granted and listed in Orange Book, bringing total of 13 patents listed in Orange Book, 12 of which expire in 2035
- One recent patent listed is a non-use patent directed to the oral formulation
- Epidiolex composition patent application in process
- TSC patent applications under review
- MS Spasticity Clinical program
- Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
- Five new MS Spasticity Phase 3 trials expected to commence in H2 2020 (2) and H1 2021 (3), any one of which could enable a NDA submission
- Phase 3 muscle tone studies – placebo-controlled cross-over design
- N=52; Expected start: Q4 2020
- N=190; Expected start: Q1 2021
- N=36 (nabiximols responders); Expected start: Q1 2021
- Phase 3 spasm frequency studies – placebo-controlled parallel group
- N=450; Expected start: Q4 2020
- N=~200 (nabiximols responders); Expected start: Q2 2021
- Spinal Cord Injury (SCI) spasticity clinical program
- Three SCI trials expected to be initiated in 2020 and 2021
N=~100 (observational clinical discovery study); Expected start: Q4 2020
- N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
- N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021
- Post-Traumatic Stress Disorder (PTSD) clinical program
- Phase 2/3 study in PTSD (N=~ 325); Expected start: H1 2021
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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