GW Pharma Generates $109 Million Revenue in 4th Quarter and $311.3 million for the full year

GW Pharmaceuticals plc, a world leader in the science, development, and commercialization of cannabinoid prescription medicines, recently announced financial results for the fourth quarter and full-year ended December 31, 2019.

Last year, was an exceptional and transformative year for GW, led by the successful launch of Epidiolex in the US and approval in Europe. The positive impact this medicine has had on thousands of patients and their families provides a compelling foundation for continued growth in 2020 per Justin Gover, GW’s Chief Executive Officer

We also expect 2020 to be an important year for our growing and developing product pipeline beyond Epidiolex as we build on our world leadership in cannabinoid science. We are focused on advancing nabiximols in the US in several indications and clinical programs with other potential products whilst continuing to bring Epidiolex to more patients in the US and Europe.

OPERATIONAL HIGHLIGHTS

  • Significant progress with Epidiolex (cannabidiol)
    • Total net product sales of Epidiolex of $104.5 million for the fourth quarter and $296.4 million for the full year
    • U.S. commercial update
      • 2020 focus on broadening prescriber base, expanding payer coverage, entering long term care segment, and expected launch of TSC indication
    • European launch underway
      • German commercial launch in Q4 2019
      • Secured positive NICE recommendation in the UK with commercial launch in Q1 2020
      • Commercial launches in France, Spain and Italy expected later this year, following pricing and reimbursement
    • Clinical progress with further indications – broadening addressable market
      • Tuberous Sclerosis Complex (TSC) sNDA filed with FDA earlier this month and MAA submission to EMA expected in Q1 2020
      • Phase 3 trial in Rett Syndrome recruiting
      • Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution, and capsule
    • Improved intellectual property rights and exclusivity
      • In addition to orphan exclusivity, 9 granted patents listed in “Orange Book” and align directly with Epidiolex FDA label with expiry dates to 2035
      • Epidiolex composition patent application recently published
      • 2 new allowed patents broadly covering use in LGS and Dravet syndrome
      • Additional patent applications under review, including patents related to the use of Epidiolex in TSC and other indications
  • Pipeline progress
    • Nabiximols (Sativex® outside of the US)
      • Multiple Sclerosis spasticity -3 positive Phase 3 trials completed in Europe
        • US pivotal clinical program expected to commence in Q2 2020 to augment existing data package
      • Spinal cord injury spasticity – clinical program expected to commence in H2 2020
      • PTSD – clinical program expected to commence in H2 2020
    • Schizophrenia (GWP42003)
      • Positive Phase 2a trial published and Phase 2b trial expected to commence H1 2020
    • CBDV in autism
      • 30-patient open label study in autism underway. Initial data expected in 2020.
      • Investigator-led 100 patient placebo-controlled trial in autism underway
      • Open label study in Rett syndrome and seizures underway
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
      • Phase 1b safety study in patients underway
      • Orphan Drug and Fast Track Designations granted from FDA and EMA

FINANCIAL HIGHLIGHTS

  • Total revenue for the quarter ended December 31, 2019 was $109.1 million compared to $6.7 million for the quarter ended December 31, 2018
  • Net loss for the quarter ended December 31, 2019 was $24.9 million compared to a net loss of $71.9 million for the quarter ended December 31, 2018
  • Cash and cash equivalents at December 31, 2019 were $536.9 million compared to $591.5 million as of December 31, 2018