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GWPH Announce 2014 Q4 Results

GW Pharmaceuticals plc (GWPH) (GWP.L) (GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the fourth quarter and year ended 30 September 2014.

“GW’s business has transformed over the last year principally as a result of the rapid advance of our Epidiolex program to treat orphan syndromes in the field of childhood epilepsy. During 2014, we have raised significant capital from U.S. investors, commenced treatment of approximately 200 children, obtained encouraging clinical data, and commenced formal clinical development in the U.S.,” stated Justin Gover, GW’s Chief Executive Officer. “In 2015, we expect to complete much of the Epidiolex development program as well as start to build a U.S. commercial presence in anticipation of future launch. Beyond Epidiolex, we expect to report Phase 3 data from the Sativex cancer pain trials in early 2015 which, if positive, would enable the filing of NDA in the U.S. during next year. We also look forward to progressing multiple clinical trials for our cannabinoid product pipeline.”

2014 HIGHLIGHTS:

  • Epidiolex(R) (cannabidiol or CBD) childhood epilepsy program
    • Company sponsored development programs in Dravet syndrome and Lennox-Gastaut syndrome (LGS)
      • Phase 2/3 Dravet syndrome trial commenced in October 2014. Part A on track to complete recruitment in December, with Part B expected to commence in Q1 2015
      • Additional Phase 3 Dravet syndrome trial and two LGS Phase 3 trials on track to commence in Q1 2015
      • Orphan Drug Designation granted by the U.S. Food and Drug Administration (FDA) for both Dravet syndrome and LGS, Fast Track Designation for Dravet syndrome
      • Orphan Drug Designation granted by the European Medicines Agency for Dravet syndrome
    • FDA authorized physician-led expanded access program
      • Clinical effect data on 58 treatment-resistant children and young adults released in October 2014 showing promising signals of efficacy and safety
      • Approximately 410 children and young adults now authorized for treatment with Epidiolex by FDA under 20 expanded access Investigational New Drug Applications (INDs)
      • Approximately 200 children now receiving Epidiolex treatment under expanded access INDs at 11 clinical sites in the U.S.
      • 6 patients being treated with Epidiolex under emergency INDs
    • State programs
      • State-based collaborations for Epidiolex clinical trials in epilepsy with the States of Georgia and New York
  • Sativex(R):
    • First Phase 3 cancer pain trial recruitment complete and last patient due to exit study in December. Initial top-line data available in early 2015. Second Phase 3 trial recruitment due to complete Q1 2015 with data expected in Q2. Data intended to lead to a New Drug Application (NDA) filing with the FDA in H2 2015
    • Fast Track designation awarded by FDA for treatment of cancer pain
    • Special Protocol Assessment (SPA) ongoing with FDA for proposed Sativex Phase 3 trial in the treatment of spasticity due to Multiple Sclerosis
    • Agreement signed with Ipsen as exclusive distributor for Sativex in Latin America (excluding Mexico)
    • Sativex approved in 27 countries and available for use in 15 countries. In-market sales volumes sold by GW’s commercial partners for the 2014 fiscal year increased by 50% over 2013
  • Cannabinoid pipeline product candidates
    • Additional epilepsy pipeline candidate GWP42006 (Cannabidivarin or CBDV), Phase 1 trial completed. Phase 2a trial due to commence H1 2015
    • Phase 1b/2a trial of GWP42002:GWP42003 in the treatment of glioma advancing to second phase. Safety data on initial cohort from first phase assessed by independent safety monitoring board with agreement to proceed into placebo-controlled phase; recent publication by St. Georges University London researchers suggesting a synergistic effect when combining cannabinoids with radiotherapy
    • Top line data from Phase 2a trial of GWP42003 extract for the treatment of ulcerative colitis show promising signals of efficacy in patients who completed course of treatment
    • Phase 2a trial of GWP42003 for the treatment of schizophrenia commenced in March 2014 with expected completion in H2 2015
    • Phase 2b trial of GWP42004 in type-2 diabetes commenced in March 2014 with expected completion in 2016

Financial Highlights

  • Total revenue for the year ended 30 September 2014 of [Pounds]30.0m ($48.7m) compared to [Pounds]27.3m ($44.3m) for the year ended 30 September 2013.
  • Net loss after tax for 2014 of [Pounds]14.7m ($23.8m) compared to [Pounds]4.5m ($7.4m) in 2013, which primarily reflects the impact of increased investment in R&D in 2014.
  • Two follow-on offerings of American Depositary Shares (“ADSs”) on the NASDAQ Global Market raising total net proceeds after expenses of approximately $212 million ([Pounds]126.3 million)
  • Cash and cash equivalents at 30 September 2014 of [Pounds]164.5m ($266.8m) compared to [Pounds]38.1m ($61.7m) as at 30 September 2013.

Conference Call and Webcast Information

The Company will host a conference call and webcast to discuss the 2014 fourth quarter and year-end financial results today at 8:00 a.m. ET / 1:00 p.m. GMT. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) 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 30 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13595968.