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GW Pharmaceuticals plc Reports Third Quarter 2020 Financial Results and Operational Progress

Written by Customer Service on . Posted in Earnings Releases And Operating Results.

– Total revenue increased 51 percent to $137.1 million – 
– Epidiolex for seizures associated with TSC launched in the U.S. –
– Nabiximols Phase 3 program in MS spasticity now recruiting –
– Conference call today at 8:30 a.m. EST –LONDON and CARLSBAD, Calif., Nov. 03, 2020 (GLOBE NEWSWIRE) — 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 third quarter ended September 30, 2020.“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 RESULTSTotal revenue for the quarter ended September 30, 2020 was $137.1 million compared to $91.0 million for the quarter ended September 30, 2019Total revenue for the first nine months of 2020 of $378.6 million compared to $202.3 million in the prior year periodNet 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, 2019Cash and cash equivalents at September 30, 2020 were $480.3 millionOPERATIONAL HIGHLIGHTSEpidiolex (cannabidiol) progress:Total Q3 net product sales of Epidiolex of $132.6 millionU.S. commercial updateU.S. Epidiolex Q3 net product sales of $121.6 millionTSC indication launched with high prescriber awareness and near universal payer coverageExpanded payer coverage85 million lives with no/broad prior authorization (+47% year-to-date)Ex-U.S. commercial updateEx-U.S. Epidyolex Q3 net product sales of $11.0 millionUK pricing and reimbursement in place. Progress in Germany, France, Italy and SpainTSC EMA submission under reviewEpidyolex approved in AustraliaStrengthening commercial exclusivityOrphan exclusivity in both the U.S. and EU13 patents listed in Orange Book, 12 of which expire in 2035Patents include formulation and method of useEpidiolex composition patent application in processTwo further Orange Book listable patents to be allowed or granted by Q1 2021Nabiximols development program:First Phase 3 MS Spasticity trial underwayPhase 3 placebo-controlled spasm frequency study (N=450)MS Spasticity trials due to commencePhase 3 placebo-controlled muscle tone studies:N=52; Expected start Q4 2020 (subject to COVID)N=190; Expected start: Q1 2021N=36 (nabiximols responders); Expected start: Q1 2021Additional Phase 3 placebo-controlled spasm frequency study (N=200) in nabiximols responders expected start Q2 2021Spinal Cord Injury (SCI) spasticity clinical program N=~100 (observational clinical discovery study); Expected start: Q1 2021N=~160 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: 2021N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: 2021Additional pipeline programs:Schizophrenia (GWP42003) Phase 2b trial now actively recruitingAutism: CBD formulation Phase 2 study expected to commence in Q1 2021CBDV investigator-led 100 patient placebo-controlled trial in autism – recruitment now resumedNew botanical cannabinoid pipeline product (GW541) Phase 1 trial underwayPotential targets within field of neuropsychiatryNeonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program Phase 1b safety study in patients continues to recruitOrphan Drug and Fast Track Designations granted from FDA and EMAConference Call and Webcast InformationGW 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 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: 38272.About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. The Company’s lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), Dravet syndrome, or tuberous sclerosis complex (TSC) in patients one year of age and older. This product has received approval in the European Union under the tradename EPIDYOLEX® for the adjunctive treatment of seizures associated with LGS or Dravet syndrome in conjunction with clobazam in patients two years and older and is under EMA review for the treatment of TSC. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury. The Company has additional cannabinoid product candidates in clinical trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.Forward-looking statements
This news release contains forward-looking statements that reflect GW’s current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the timing and outcomes of regulatory or intellectual property decisions, the relevance of GW products commercially available and in development, the clinical benefits of EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.Enquiries:
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