On November 3, 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 third quarter ended September 30, 2020 (Press release, GW Pharmaceuticals, NOV 3, 2020, View Source [SID1234569763]).
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"We are pleased to report strong revenue growth in the 3rd quarter despite the challenges presented by COVID-19. Epidiolex meets a serious unmet need within the field of epilepsy and we expect the product to demonstrate continued strong growth in the months and years ahead. The recent expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers," stated Justin Gover, GW’s Chief Executive Officer. "We have also now commenced the pivotal Phase 3 program for nabiximols in the treatment of multiple sclerosis spasticity, which provides multiple opportunities for an NDA submission, including as early as next year. Beyond nabiximols, we are advancing several clinical-stage pipeline candidates, including the recent start of a Phase 2 trial in schizophrenia."
FINANCIAL RESULTS
Total revenue for the quarter ended September 30, 2020 was $137.1 million compared to $91.0 million for the quarter ended September 30, 2019
Total revenue for the first nine months of 2020 of $378.6 million compared to $202.3 million in the prior year period
Net loss for the quarter ended September 30, 2020 was $12.2 million compared to net loss of $13.8 million for the quarter ended September 30, 2019
Cash and cash equivalents at September 30, 2020 were $480.3 million
OPERATIONAL HIGHLIGHTS
Epidiolex (cannabidiol) progress:
Total Q3 net product sales of Epidiolex of $132.6 million
U.S. commercial update
U.S. Epidiolex Q3 net product sales of $121.6 million
TSC indication launched with high prescriber awareness and near universal payer coverage
Expanded payer coverage
85 million lives with no/broad prior authorization (+47% year-to-date)
Ex-U.S. commercial update
Ex-U.S. Epidyolex Q3 net product sales of $11.0 million
UK pricing and reimbursement in place. Progress in Germany, France, Italy and Spain
TSC EMA submission under review
Epidyolex approved in Australia
Strengthening commercial exclusivity
Orphan exclusivity in both the U.S. and EU
13 patents listed in Orange Book, 12 of which expire in 2035
Patents include formulation and method of use
Epidiolex composition patent application in process
Two further Orange Book listable patents to be allowed or granted by Q1 2021
Nabiximols development program:
First Phase 3 MS Spasticity trial underway
Phase 3 placebo-controlled spasm frequency study (N=450)
MS Spasticity trials due to commence
Phase 3 placebo-controlled muscle tone studies:
N=52; Expected start Q4 2020 (subject to COVID)
N=190; Expected start: Q1 2021
N=36 (nabiximols responders); Expected start: Q1 2021
Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021
Spinal Cord Injury (SCI) spasticity clinical program
N=~100 (observational clinical discovery study); Expected start: Q1 2021
N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021
N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021
Additional pipeline programs:
Schizophrenia (GWP42003)
Phase 2b trial now actively recruiting
Autism:
CBD formulation Phase 2 study expected to commence in Q1 2021
CBDV investigator-led 100 patient placebo-controlled trial in autism – recruitment now resumed
New botanical cannabinoid pipeline product (GW541)
Phase 1 trial underway
Potential targets within field of neuropsychiatry
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 8:30 am EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (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: 38272.