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

• Total revenue increased 68 percent to $121.3 million
• Epidiolex approved in the U.S. for seizures associated with TSC, launch expected this month
• Conference call today at 4:30 p.m. EDT

LONDON and CARLSBAD, Calif., Aug. 06, 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 second quarter ended June 30, 2020.

We were pleased with the strength of U.S. Epidiolex sales in the second quarter in spite of the COVID-19 pandemic. Further, the recent approval and imminent launch of Epidiolex for the treatment of seizures associated with TSC provides a meaningful new opportunity to accelerate momentum through the second half of 2020 and beyond.

Justin Gover, GW’s CEO

We also continue to be excited about the potential of our product pipeline, in particular nabiximols, for which we recently outlined our accelerated US development strategy in the treatment of spasticity in patients with MS and other conditions. We look forward to commencing the nabiximols Phase 3 program as well as multiple other pipeline clinical trials in the second half of the year.

FINANCIAL RESULTS

• Total revenue for the quarter ended June 30, 2020 was $121.3 million compared to $72.0 million for the quarter ended June 30, 2019
• Net loss for the quarter ended June 30, 2020 was $8.8 million compared to net income of $79.7 million for the quarter ended June 30, 2019. The prior year quarter included net proceeds of $104.1 million from the sale of a Rare Pediatric Priority Review Voucher.
• Cash and cash equivalents at June 30, 2020 were $477.6 million

OPERATIONAL HIGHLIGHTS

• Epidiolex (cannabidiol) progress:
  • Total Q2 net product sales of Epidiolex of $117.7 million
  • U.S. commercial update
    • U.S. Epidiolex Q2 net product sales of $111.1 million
    • TSC indication approved by FDA, August commercial launch planned
    • TSC payer reimbursement anticipated quickly following launch
• European commercial update
  • Ex-U.S. Epidyolex Q2 net product sales of $6.6 million
  • Pricing & reimbursement progress in Germany, France and Italy
  • TSC EMA submission under review
• Clinical progress with additional indications
  • Phase 3 trial in Rett Syndrome expected to re-commence in H2 2020
• Strengthening commercial exclusivity
  • Orphan exclusivity in both the U.S. and EU
  • 3 new patents granted and listed in Orange Book, bringing total of 13 patents listed in Orange Book, 12 of which expire in 2035
    • One recent patent listed is a non-use patent directed to the oral formulation
  • Epidiolex composition patent application in process
  • TSC patent applications under review
• Nabiximols
  • MS Spasticity Clinical program
    • Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
    • Five new MS Spasticity Phase 3 trials expected to commence in H2 2020 (2) and H1 2021 (3), any one of which could enable a NDA submission
      • Phase 3 muscle tone studies – placebo-controlled cross-over design
        • N=52; Expected start: Q4 2020
        • N=190; Expected start: Q1 2021
        • N=36 (nabiximols responders); Expected start: Q1 2021
      • Phase 3 spasm frequency studies – placebo-controlled parallel group
        • N=450; Expected start: Q4 2020
        • N=~200 (nabiximols responders); Expected start: Q2 2021
• Spinal Cord Injury (SCI) spasticity clinical program
  • Three SCI trials expected to be initiated in 2020 and 2021
  • N=~100 (observational clinical discovery study); Expected start: Q4 2020
  • N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
  • N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021
• Post-Traumatic Stress Disorder (PTSD) clinical program
  • Phase 2/3 study in PTSD (N=~ 325); Expected start: H1 2021
• Additional pipeline programs
  • Schizophrenia (GWP42003)
    • Phase 2b trial expected to commence H2 2020
  • CBDV in autism trials expected to recommence in H2 2020
    • 30-patient open label study in autism
    • Investigator-led 100 patient placebo-controlled trial in autism
  • 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 4:30 pm EDT. To participate in the conference call, please dial 833-937-1050 (toll free from the U.S. and Canada) or 845-403-8302 (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: 35770.

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. GW is currently 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.

Enquiries:

GW Pharmaceuticals plc
Stephen Schultz, VP Investor Relations 917 280 2424 / 401 500 6570

U.S. Media Enquiries:
Sam Brown Inc. Healthcare Communications
Christy Curran 615 414 8668
Mike Beyer 312 961 2502

Ex-U.S. media enquiries
Ben Atwell, FTI Consulting +44 (0)203 727 1000

Original press release

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