GW Pharmaceuticals plc Reports Fiscal Second Quarter 2018 Financial Results and Operational Progress

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May 08, 2018

- Positive unanimous vote at Epidiolex® (cannabidiol) FDA Advisory Committee meeting –

- NDA PDUFA goal date scheduled for June 27, 2018 -

- Conference call today at 4:30 p.m. EST -

London, UK, Carlsbad, CA, 8 May 2018: GW Pharmaceuticals plc (NASDAQ: GWPH, 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 second quarter ended 31 March 2018.                                    

“The positive outcome of the Epidiolex FDA Advisory Committee meeting was a momentous event for GW. The strength and consistency of the clinical data, together with the public presentations that featured very moving personal stories of the challenges associated with managing these difficult forms of epilepsy, led to a unanimous vote in support of approval,” stated Justin Gover, GW’s Chief Executive Officer. “With our late June FDA decision date nearing, our commercial team is busy preparing to launch Epidiolex in the second half of this year.  Should Epidiolex be approved, we believe that this will signal a major vote of confidence in GW’s cannabinoid platform to discover and develop prescription medicines that meet exacting regulatory standards and will serve us to accelerate a number of important pipeline programs that have the potential to offer additional value.”

OPERATIONAL HIGHLIGHTS

  • Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)

    • Regulatory:

      • NDA for the adjunctive treatment of seizures associated with LGS and Dravet PDUFA goal date of June 27, 2018
      • Positive, unanimous vote in support of approval by FDA Advisory Committee
      • Conditional grant of rare pediatric disease designation by FDA
      • European submission accepted for review by the EMA.  Expected decision in Q1 2019
    • Manufacturing
      • FDA pre-approval cGMP inspections successfully completed with no 483 citations
    • Clinical data:
      • Second Phase 3 LGS trial accepted for publication. Paper expected to be released shortly
      • New data presented at the American Academy of Neurology (AAN) Annual Meeting
        • Long-term safety and efficacy data in patients LGS and Dravet syndrome presented
        • buse liability data
    • Clinical trials
      • Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019
      • Second Phase 3 trial in Dravet syndrome enrollment complete with data expected H2 2018
      • Part A of two-part Phase 2/3 trial in Infantile Spasms nearing completion; based on currently available data unlikely to proceed into Part B
    • Expanded access program and open label extension:
      • Over 2,000 patients now have been exposed to Epidiolex treatment
    • Commercial:
      • U.S. Sales leadership team in place and preparing for launch
      • Active engagement with U.S. payors is ongoing
      • Commercial footprint established in top 5 EU markets
    • Life-cycle management
      • Several new formulations of CBD in development including modified liquid formulations, a solid dose form and an intravenous formulation
    • Intellectual property
      • 7 key favorable patent application decisions by USPTO related to the use of CBD in epilepsy

        • 5 patent grants following March 2018 Notices of Allowance
        • 2 new Notices of Allowance issued by USPTO
        • Additional patent applications under review and being filed as new data is generated
  • Pipeline progress
    • Sativex® (nabiximols) for Multiple Sclerosis spasticity

      • US development and commercialization rights wholly owned by GW
      • Three positive Phase 3 trials completed in Europe
      • Plans to engage with FDA in H2 18 with a view to commencing a single U.S. pivotal trial
    • CBDV in Autism Spectrum Disorders
      • 10-patient investigator-initiated expanded access program for seizures associated with autism underway. Data expected Q4 18.
      • Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q3 2018
      • Open label study in Rett syndrome due to commence Q3 and Phase 2 placebo-controlled trial in Rett syndrome due to commence in Q4 2018 
        • Orphan Drug Designation from FDA and EMA for CBDV for the treatment of Rett syndrome
    • CBD:THC in Glioblastoma
      • Phase 2 study showed significant increase in one year survival compared to placebo
      • Pivotal clinical development program plans under development
      • Orphan Drug Designation from both FDA and EMA for CBD:THC to treat glioblastoma
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
      • Phase 1 trial complete
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
      • Phase 2 trial in planning

FINANCIAL HIGHLIGHTS

  • Cash and cash equivalents at 31 March 2018 of £346.8 million ($487.2 million) compared to £241.2 million as at 30 September 2017
  • Revenue for the six months ended 31 March 2018 of £8.1 million ($11.4 million) compared to £3.7 million for the six months ended 31 March 2017
  • Loss for the six months ended 31 March 2018 of £109.6 million ($154.0 million) compared to £50.0 million for the six months ended 31 March 2017

Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 31 March 2018 of $1.40495 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the second quarter 2018 financial results today at 4:30 pm EST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) 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 90 days. Replay Numbers: (toll free):1-877-481-4010 or 919-882-2331 (international). For both dial-in numbers please use conference ID # 13679685 and PIN: 29077.

About GW Pharmaceuticals plc and Greenwich Biosciences

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, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted regulatory applications in the U.S. and Europe for the adjunctive treatment of Lennox-Gastaut syndrome and Dravet syndrome. The Company continues to evaluate Epidiolex in additional rare epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the company is now planning a US Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, 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 timing and outcomes of regulatory or intellectual property decisions, 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 the Company’s regulatory processes, and the level of 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 including the most recent Form 20-F filed on 4 December 2017. 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.

Enquiries:

GW Pharmaceuticals plc

 

Stephen Schultz, VP Investor Relations (U.S.)

917 280 2424 / 401 500 6570

U.S. Media Enquiries:

Sam Brown Inc. Healthcare Communications

 

Christy Curran

Mike Beyer

615 414 8668

312 961 2502

EU Media Enquiries:

FTI Consulting

 

Ben Atwell

Simon Conway

+44 (0) 3727 1000

 

 

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