GWPH - GW Pharmaceuticals Stock Pops As Earnings Beat Estimates

GW Pharmaceuticals plc (Nasdaq: GWPH) stock was rising over 6% in early trading as the company delivered solid third-quarter results.  The company reported total revenue of $137.1 million for the quarter ending September 30, 2020, a big jump over the $91.0 million for the same time period in 2019. This beat the Yahoo Finance average analyst estimates of $127 million for revenue.

The market was cheered by the drop in net losses to $12.2 million versus last year’s net loss of $13.8 million for the 2019 third quarter. The net loss per share was ($0.03), which also beat the analyst estimate for a loss of ($0.83). GW Pharmaceuticals said it had cash and cash equivalents of $480.3 million.

“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. The recently 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.”

The cannabidiol epilepsy drug Epidiolex is having great results. Total third-quarter net product sales of Epidiolex were $132.6 million and U.S. Epidiolex third-quarter net product sales were $121.6 million. TSC indication launched with high prescriber awareness and near-universal payer coverage.

Additional study updates provided by the company were as follows:

• 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