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GW Pharmaceuticals plc Reports Financial Results and Operational Progress for the First Quarter Ended March 31, 2019

https://finance.yahoo.com/news/gw-pharmaceuticals-plc-reports-financial-200100422.html

GlobeNewswire•May 6, 2019
- Epidiolex U.S. Q1 net sales of $33.5m -
- Positive Phase 3 pivotal results in Tuberous Sclerosis Complex, sNDA submission expected in Q4 2019 -
- Conference call today at 4:30 p.m. EDT -

CARLSBAD, Calif., May 06, 2019 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ: GWPH, GW, the Company or the Group), the world leader in the science, development and commercialization of cannabinoid prescription medicines, announces financial results for the first quarter ended March 31, 2019.

“We are pleased to report a strong launch of Epidiolex in the US and continue to be encouraged by the level of support for this medicine from patients, caregivers and healthcare professionals. As the first and only plant-derived CBD medicine approved by the FDA, Epidiolex offers a novel treatment option for patients with Lennox-Gastaut Syndrome and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy”, stated Justin Gover, GW’s Chief Executive Officer. “In addition, we are delighted to report today positive results from a Phase 3 trial in patients with seizures associated with Tuberous Sclerosis Complex, and are excited at the prospect of expanding the use of Epidiolex to these high need patients in the future.”

OPERATIONAL HIGHLIGHTS

Darren Cline appointed U.S. Chief Commercial Officer
Epidiolex® (cannabidiol)
U.S. commercial update
Q1 Net sales of $33.5m
Over 7,600 patients have received Epidiolex prescriptions since launch
Over 1,900 physicians have generated dispensed prescriptions since launch
Pharmacy distribution network now includes over 145 distribution points
Approximately 75 percent of 900 patients in expanded access program and open label extension now transitioned to commercial product. Remaining patients expected to transition by end of Q2.
Rapid and encouraging payor coverage decisions
Over 90 percent of all U.S. lives now covered – 65 percent of which have either Prior Authorization (PA) to indication or less restrictive
New commercial coverage determination recently announced by United HealthCare, OptumRx and Prime Therapeutics
99 percent of State Fee-for-Service Medicaid lives now have a coverage determination with 67 percent of covered lives having either PA to indication or less restrictive
7 States covering Epidiolex without restrictions
Approximately 90 percent of Managed Medicaid lives have a coverage determination with 40 percent having a PA to indication or less restrictive
Target physician coverage
The sales organization has to date interacted with about 70 percent of the over 5,000 target healthcare professionals including all Level 3 and 4 epilepsy centers
European regulatory and pre-launch progress
CHMP opinion expected mid-2019
Launches expected in major five European markets by end of 2019
Manufacturing
Commercial manufacturing and supply chain running smoothly
Production capacity sufficient to meet expected demand in both U.S. and Europe
Clinical trials
Positive results in Phase 3 trial in Tuberous Sclerosis Complex
Primary efficacy measure achieved with both Epidiolex doses compared to placebo
sNDA submission expected in Q4 2019
IND open for pivotal Phase 3 trial in Rett Syndrome with expected start in Q2 2019
Life-cycle management
Several new formulations of CBD in development including modified oral solution, capsule and intravenous formulation
PK data expected in 2019
Exclusivity
7 years of orphan exclusivity confirmed by FDA, plus 6-month pediatric extension expected. 10 years of orphan exclusivity in Europe plus 2 year pediatric extension
Key favorable patent grants by USPTO related to the use of CBD in epilepsy
Patents align directly with new Epidiolex FDA label and listed in “Orange Book”
Patent expiry dates to 2035
Additional patent applications under review, including patents related to the use of Epidiolex in TSC
Pipeline progress
Sativex® (nabiximols)
FDA meeting in December 2018 resulted in regulatory pathway in the U.S.
Initial U.S. target indication: Multiple Sclerosis spasticity
Single Phase 3 pivotal study expect to commence in Q4 2019
Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
CBDV
Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population
Company sponsored IND open for 30-patient open label study in autism
Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder has commenced recruitment
Open label study in Rett syndrome and seizures has commenced
FINANCIAL HIGHLIGHTS

Cash and cash equivalents at March 31, 2019 were $521.7 million compared to $591.5 million as of December 31, 2018
Revenue for the quarter ended March 31, 2019 was $39.2 million compared to $3.0 million for the quarter ended March 31, 2018
Net loss for the quarter ended March 31, 2019 was $50.1 million compared to $69.5 million for the quarter ended March 31, 2018
Closed transaction to sell Rare Pediatric Disease Priority Review Voucher for $105 million on April 5, 2019. The sale will be reflected in our Q2 2019 results
Conference Call and Webcast Information
GW Pharmaceuticals will host a conference call and webcast to discuss the quarter ending March 31, 2019 financial results today at 4:30 pm EDT. 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 http://www.gwpharm.com. 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: 47716.