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Tuesday, February 26, 2019

-=GW Pharma (GWPH) reported earnings on Tue 26 Feb 19 (a/h)

GW Pharma beats by $0.04, beats on revs
  • Reports Q1 (Dec) loss of $0.20 per share, excluding non-recurring items, $0.04 better than the S&P Capital IQ Consensus of ($0.24); revenues rose 67.5% year/year to $6.7 mln vs the $5.35 mln S&P Capital IQ Consensus.
Pipeline progress
  • Sativex (nabiximols)
    • FDA meeting in December resulted in regulatory pathway in the U.S. 
      • Initial U.S. target indication: Multiple Sclerosis spasticity 
      • Single Phase 3 pivotal study expect to commence in Q4 2019
    • U.S. development and commercialization rights wholly owned by GW
    • Over 10 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
  • CBDV
    • Initial data from 5 patient expanded access program in patients with seizures and autism presented at American Epilepsy Society Annual Meeting suggest that CBDV is well tolerated and has potential as an AED/behavioral/cognitive medicine in the autism/epilepsy population 
    • Company sponsored IND open for 30-patient open label study in autism -
    • Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder to commence in H1 2019
    • Open label study in Rett syndrome and seizures due to commence H1 2019

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