GW Pharmaceuticals plc: GW Pharmaceuticals plc Reports 2014 Q4 and Full Year Financial Results

Tickers: GWPH
December 2, 2014

-Conference Call Today at 8:00 a.m. ET, 1:00 p.m. GMT-

LONDON, Dec. 2, 2014 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (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."

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2014 HIGHLIGHTS:

  • Epidiolex® (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®:
    • 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 £30.0m ($48.7m) compared to £27.3m ($44.3m) for the year ended 30 September 2013.
  • Net loss after tax for 2014 of £14.7m ($23.8m) compared to £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 (£126.3 million)
  • Cash and cash equivalents at 30 September 2014 of £164.5m ($266.8m) compared to £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.

About GW Pharmaceuticals plc

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. GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW is also advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex®, which is in Phase 2/3 clinical development for the treatment of Dravet syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Lennox-Gastaut syndrome. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type 2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding financial performance, the timing of clinical trials, the relevance of GW products commercially available and in development, the clinical benefits of Sativex® and Epidiolex® and the safety profile and commercial potential of Sativex and Epidiolex. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of GW's research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex and other products by consumer and medical professionals. A further list and description of risks and uncertainties associated with an investment in GW can be found in GW's filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Note Regarding Expanded Access Studies

Expanded access studies are uncontrolled, carried out by individual investigators, and not typically conducted in strict compliance with Good Clinical Practices, all of which can lead to a treatment effect which may differ from that in placebo-controlled trials. Data from these studies provide only anecdotal evidence of efficacy for regulatory review, contain no control or comparator group for reference and are not designed to be aggregated or reported as study results. Moreover, data from such small numbers of patients may be highly variable. Such information may not reliably predict data collected via systematic evaluation of the efficacy in company-sponsored clinical trials. Reliance on such information may lead to Phase 2 and 3 clinical trials that are not adequately designed to demonstrate efficacy and could delay or prevent GW's ability to seek approval of Epidiolex. Expanded access programs may provide supportive safety information for regulatory review. Physicians conducting these studies may use Epidiolex in a manner inconsistent with the protocol, including in children with conditions different from those being studied in GW-sponsored trials. Any adverse events or reactions experienced by subjects in the expanded access program may be attributed to Epidiolex and may limit GW's ability to obtain regulatory approval with labeling that GW considers desirable, or at all.

Enquiries:

GW Pharmaceuticals plc (Today) +44 20 3727 1000
Justin Gover, Chief Executive Officer (Thereafter) + 44 1980 557000
Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen (UK) + 44 20 3727 1000
Robert Stanislaro (U.S.) 212 850 5657
Trout Group, LLC (U.S. investor relations)
Todd James / Chad Rubin 646 378 2900
GW Pharmaceuticals plc 
("GW" or "the Company" or "the Group")

Preliminary Results for the Fourth Quarter and Year Ended 30 September 2014

OPERATIONAL OVERVIEW

GW Overview

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. In 16 years of operations, GW has established a world leading position in the development of plant-derived cannabinoid therapeutics through its proven drug discovery and development platform, a robust intellectual property portfolio and its regulatory and manufacturing expertise.

GW commercialized the world's first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis (MS) in 27 countries outside the United States (U.S.). GW is also evaluating Sativex in a Phase 3 program for the treatment of cancer pain intended to support the submission of a New Drug Application (NDA) for Sativex in cancer pain with the U.S. Food and Drug Administration (FDA) and in other markets around the world.

Beyond Sativex, GW is advancing an orphan drug program in the field of childhood epilepsy with a particular focus on Epidiolex®, a liquid formulation of pure plant-derived cannabidiol (CBD). Epidiolex has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of both Dravet syndrome and Lennox-Gastaut syndrome (LGS), each of which are severe infantile-onset, genetic, drug-resistant epilepsy syndromes. GW has commenced a Phase 2/3 placebo-controlled clinical trial in patients with Dravet syndrome and expects to commence an additional Phase 3 trial in Dravet syndrome and two Phase 3 trials in LGS in the first quarter of 2015.

In addition, GW's cannabinoid platform offers a deep pipeline of additional product candidates including distinct clinical-stage candidates targeting epilepsy (CBDV), glioma, ulcerative colitis, schizophrenia and type-2 diabetes.

U.S. Follow-on Offerings

In 2014, GW successfully completed two follow-on offerings on the NASDAQ Global Market. In January, GW issued a total of 2,807,275 American Depositary Shares ("ADSs") at a price of $36.00 per ADS. In June, the Company issued a total of 1,455,000 ADSs at a price of $86.83 per ADS. Total net proceeds for these two offerings after expenses were approximately $212 million (£126.3 million). The funds raised in these offerings are primarily intended to advance the clinical development of Epidiolex, to support pre-launch commercial activities for Epidiolex in the U.S., the expansion of Epidiolex growing and manufacturing capability and build-up of inventory in preparation for launch of Epidiolex, if approved. GW also expects to use the funds toward the advancement of other early stage pipeline opportunities, with a particular focus on orphan diseases.

Epilepsy Drug Development Programs

GW is currently focused on two epilepsy development programs that represent important product candidates within GW's epilepsy franchise and have the potential to yield a