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

• 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 3^rd 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.

Justin Gover, GW’s Chief Executive Officer

The recent expanded indication for the treatment of seizures associated with TSC has been very well received by patients, clinicians and payers.

Gover added, “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 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.

Original Press Release

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