– Total revenue of $120.6 million –
– Total Epidiolex® net product sales of $116.1 million –
– Conference call today at 4:30 p.m. EDT –LONDON and CARLSBAD, Calif., May 11, 2020 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq: GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces financial results for the first quarter ended March 31, 2020.“In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August,” stated Justin Gover, GW’s CEO. “In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science.”FINANCIAL RESULTSTotal revenue for the quarter ended March 31, 2020 was $120.6 million compared to $39.2 million for the quarter ended March 31, 2019Net loss for the quarter ended March 31, 2020 was $8.0 million compared to a net loss of $50.1 million for the quarter ended March 31, 2019Cash and cash equivalents at March 31, 2020 were $500.9 million compared to $536.9 million as of December 31, 2019OPERATIONAL HIGHLIGHTSEpidiolex (cannabidiol) progress:Total Q1 net product sales of Epidiolex of $116.1 millionU.S. commercial updateU.S. Epidiolex Q1 net product sales of $106.1 millionAugust commercial launch planned for TSC indication; July 31 PDUFA dateEpidiolex descheduled by the DEAPayer discussions focused on pending TSC approval and expanding coverageEuropean commercial updateSuccessful commercial launches in Germany and UKImportant pricing & reimbursement progress in Germany & Italy. Commercial launches in France, Spain and Italy on track for later this yearTSC EMA submission accepted for reviewClinical progress with additional indications to broaden addressable marketPhase 3 trial in Rett Syndrome (recruitment temporarily on hold)Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution and capsuleStrengthening commercial exclusivityOrphan exclusivity in both the U.S. and EU10 granted patents listed in Orange Book with expiry dates to 2035, including 1 patent recently granted broadly covering use in LGS and Dravet syndromeEpidiolex composition patent application in process1 new allowed patent covering seizure sub-type use in Dravet syndrome expected to grant in Q2 2020TSC patent applications under review with initial grant expected in 2020Pipeline progressStart of new clinical programs delayed until H2 2020 due to current COVID restrictionsNabiximols (Sativex® outside of the US)Multiple Sclerosis spasticityUS pivotal clinical program expected to commence in H2 2020 to augment existing data package3 positive Phase 3 trials completed in EuropeSpinal cord injury spasticity – clinical program expected to commence in H2 2020PTSD – clinical program expected to commence in H2 2020Schizophrenia (GWP42003)Phase 2b trial expected to commence H2 2020CBDV in autism30-patient open label study in autismInvestigator-led 100 patient placebo-controlled trial in autismOpen label study in Rett syndrome and seizuresNeonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commencedPhase 1b safety study in patients continues to recruit due to emergency care environmentOrphan Drug and Fast Track Designations granted from FDA and EMAConference Call and Webcast InformationGW Pharmaceuticals will host a conference call and webcast 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: 34479.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) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. 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, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 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, 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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