On August 6, 2020 GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, reported financial results and operating progress for the second quarter ended June 30, 2020 (Press release, GW Pharmaceuticals, AUG 6, 2020, View Source [SID1234568621]).
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"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. 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."
FINANCIAL RESULTS
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
OPERATIONAL HIGHLIGHTS
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
Nabiximols
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
Additional pipeline programs
Schizophrenia (GWP42003)
Phase 2b trial expected to commence H2 2020
CBDV in autism trials expected to recommence in H2 2020
30-patient open label study in autism
Investigator-led 100 patient placebo-controlled trial in autism
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1b safety study in patients continues to recruit
Orphan Drug and Fast Track Designations granted from FDA and EMA
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast today at 4:30 pm EDT. To participate in the conference call, please dial 833-937-1050 (toll free from the U.S. and Canada) or 845-403-8302 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at View Source A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference Replay ID: 35770.