GWPH GW Pharmaceuticals Plc

125.35
-0.84  -1%
Previous Close 126.19
Open 127.5
52 Week Low 67.98
52 Week High 180.75
Market Cap $3,895,840,019
Shares 31,079,697
Float 23,851,214
Enterprise Value $2,924,232,985
Volume 271,061
Av. Daily Volume 357,510
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Upcoming Catalysts

Drug Stage Catalyst Date
Epidiolex
Tuberous Sclerosis Complex
PDUFA priority review
PDUFA priority review
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GWP42006 (CBDV)
Autism
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
GWP42003
Schizophrenia
Phase 2
Phase 2
Phase 2b trial to commence 2H 2020.
Sativex
Spasticity due multiple sclerosis
Phase 3
Phase 3
Phase 3 trial planned for 2H 2020.
Epidiolex
Rett syndrome
Phase 3
Phase 3
Phase 3 trial has commenced - May 6, 2019. Recruitment on hold due to COVID-19.
GWP42006 (CBDV)
Rett syndrome
Phase 2
Phase 2
Phase 2 open-label trial underway - noted February 25, 2020.
Epidiolex
Dravet Syndrome and Lennox-Gastaut syndrome
Approved
Approved
Approval announced June 25, 2018.
GWP42006 (CBDV)
Epilepsy
Phase 2
Phase 2
Phase 2 data released February 21, 2018 - primary endpoint not met.
GWP42004
Type 2 diabetes
Phase 2
Phase 2
Phase 2 trial did not meet endpoint

Latest News

  1.  - Potential accelerated pathway to NDA submission - 
    - Clinical program of five Phase 3 trials provides multiple options for NDA submission, as early as 2021 -
    - Webcast featuring a range of guest speakers to be held today from 10:00am-12:00pm EDT -

    CARLSBAD, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces the Company's strategy for bringing its pipeline product nabiximols to the U.S. market. This strategy includes multiple opportunities for the submission of an initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the earliest…

     - Potential accelerated pathway to NDA submission - 

    - Clinical program of five Phase 3 trials provides multiple options for NDA submission, as early as 2021 -

    - Webcast featuring a range of guest speakers to be held today from 10:00am-12:00pm EDT -

    CARLSBAD, Calif., June 30, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group))), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces the Company's strategy for bringing its pipeline product nabiximols to the U.S. market. This strategy includes multiple opportunities for the submission of an initial New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), the earliest of which could occur in 2021. GW will host a webcast today to provide insight into the U.S. Phase 3 clinical program and commercial opportunity for nabiximols.

    "We are excited to present the details of our clinical program and regulatory strategy for nabiximols, which we believe support the potential for a substantial near-term commercial opportunity in the U.S. Following constructive meetings with the FDA, we are now commencing a Phase 3 clinical program that provides multiple opportunities for an NDA submission, including as early as 2021", stated Justin Gover, GW's Chief Executive Officer. "Beyond the initial target indication of MS spasticity, our Phase 3 clinical program is designed to achieve a broad spasticity label over time. This development strategy, together with the long-term exclusivity potential of nabiximols, provides GW with confidence that this product should represent a significant value driver for GW."

    Highlights of GW's nabiximols U.S. clinical development strategy:

    MS Spasticity Clinical program

    • Three positive Phase 3 MS spasticity trials already completed outside of the U.S.
    • Five new MS Spasticity Phase 3 trials are expected to commence in H2 2020 (2) and H1 2021 (3), any one of which we believe could enable a NDA submission
      • Phase 3 muscle tone studies – placebo-controlled cross-over design
        • N=52; Expected start: Q4 2020
        • N=190; Expected start: Q1 2021
        • N=36 (nabiximols responders); Expected start: Q1 2021
      • Phase 3 spasm frequency studies – placebo-controlled parallel group
        • N=450; Expected start: Q4 2020
        • N=~200 (nabiximols responders); Expected start: Q2 2021

    Spinal Cord Injury (SCI) spasticity clinical program

    • Three SCI trials are expected to be initiated in 2020 and 2021
      • N=~100 (observational clinical discovery study); Expected start: Q4 2020
      • N=~100 (muscle tone in nabiximols responders); Placebo-controlled parallel group design. Expected start: Q2 2021
      • N=~400 (spasm frequency); Placebo-controlled parallel group design. Expected start: H2 2021

                This second spasticity indication may lead to broad anti-spasticity labeling and usage.

                 

    Post Traumatic Stress Disorder (PTSD) clinical program

    • We are also exploring the potential of nabiximols to reduce sleep disturbance symptoms, as well as anxiety and irritability, in patients with PTSD
    • A Phase 2/3 study in PTSD will have approximately 325 subjects and is anticipated to be initiated in H1 2021

    GW will host a webcast today, June 30th, 2020 from 10:00am-12:00pm EDT.  Justin Gover, GW's Chief Executive Officer, will host this event. The presentation will feature external medical and research experts as well as GW executives.  A replay will be available for soon after the live presentation. Both the live webcast link and the archive will be available on GW's corporate website at www.gwpharm.com on the Investor section homepage.

    About Nabiximols

    Nabiximols is expected to enter pivotal Phase 3 development in the United States in the second half of 2020. The U.S. commercial rights are owned by GW. GW anticipates developing multiple indications for nabiximols with an initial focus on spasticity. The initial target indication will be for the treatment of MS spasticity, to be followed by Spinal Cord Injury spasticity and Post Traumatic Stress Disorder, or PTSD.

    Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as a mouth spray.

    Nabiximols is known as Sativex® outside of the United States and is commercially available for the treatment of MS spasticity in numerous countries. These approvals were based on multiple pivotal trials conducted in Europe1.

    1: Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Forward-looking statement



    This press release contains forward-looking statements that reflect GW's current expectations regarding future events, including statements regarding the timing of clinical trials, the timing of regulatory filings and approvals, the timing and outcomes of regulatory or intellectual property decisions, and the clinical benefits and commercial potential of nabiximols (marketed as Sativex® outside the US). Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the risks and uncertainties which 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.

    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
      
      
      

     

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  2. GW's cannabis-based medicine rescheduled following approval by the European Medicines Agency (EMA) and an independent assessment by the Advisory Council on the Misuse of Drugs (ACMD)

    Burden on patients, their families and healthcare professionals eased due to the reduction in controlled drug requirements  

    LONDON, June 24, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) ("GW", "the Company" or "the Group"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the UK Home Office has reclassified EPIDYOLEX (cannabidiol) as a Schedule 5 drug. This change will take effect immediately in all four of the constituent nations of the UK – with Northern Ireland enacting…

    GW's cannabis-based medicine rescheduled following approval by the European Medicines Agency (EMA) and an independent assessment by the Advisory Council on the Misuse of Drugs (ACMD)

    Burden on patients, their families and healthcare professionals eased due to the reduction in controlled drug requirements  

    LONDON, June 24, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH) ("GW", "the Company" or "the Group"), a world leader in discovering, developing and delivering regulatory approved cannabis-based medicines, today announces that the UK Home Office has reclassified EPIDYOLEX (cannabidiol) as a Schedule 5 drug. This change will take effect immediately in all four of the constituent nations of the UK – with Northern Ireland enacting separate legislation1 – and sees the medicine move from Schedule 2 to Schedule 5 under the Misuse of Drugs Regulations 2001.

    "The decision to move EPIDYOLEX to a low level of control is an important one for patients, their families, healthcare professionals, pharmacists and the NHS as a whole – reducing costs and ensuring the medicine can be dispensed more easily," said Chris Tovey, GW's Chief Operating Officer. "The extensive pre-clinical and clinical data that GW developed to support the medicine's approval by regulatory authorities was pivotal to this important schedule change, and we would like to thank the MHRA, ACMD and Home Office for scrutinising this data and making this change in such a short timeframe. We remain committed to expanding the high-quality evidence base for cannabis-based medicines and securing further regulatory approvals because doing so is in the interests of patients and healthcare professionals and can support further rescheduling."

    The ACMD and its Technical Committee recommended the schedule change to Kit Malthouse MP, Minister of State for Crime and Policing, on 29 January 2020. This followed the submission of a written dossier and oral presentation from the MHRA, which drew on the substantial data package developed by GW as part of the medicine's review and subsequent approval by the regulatory authorities in September 2019. The medicine is approved in the EU for adjunctive therapy of seizures associated with Lennox Gastaut syndrome or Dravet syndrome, in conjunction with clobazam, for patients from 2 years of age and older.

    In its recommendation to the Minister, the ACMD cited the "low risk of abuse potential, low risk of dependency and low risk of diversion" as reasons for the reclassification from a schedule 2 controlled drug to a schedule 5 controlled drug.2 The ACMD also cautioned that GW's medicine is "distinct from other commercially available CBD containing supplements that have not sought marketing authorisation as a medicine" and that the schedule change therefore applies exclusively to EPIDYOLEX.

    The recommendation was accepted by the Minister on 22 April 2020 and secondary legislation was tabled to enact the change on 3 June 2020.3 GW's medicine is now exempt from virtually all controlled drug requirements.4 Patients and their families will now have greater flexibility on the quantity of medicine they can receive and be able to benefit from repeat prescriptions, thereby potentially reducing travel to hospital pharmacies, whilst healthcare professionals and pharmacists will benefit from reduced controls around the storage and reporting requirements that exist for medicines under Schedule 2.

    1. HM Government, The Misuse of Drugs (Amendment No.2) Regulations (Northern Ireland) 2020, Statutory Rules of Northern Ireland, 2020 No.104, http://www.legislation.gov.uk/nisr/2020/104/introduction/made
    2. Advisory Council on the Misuse of Drugs, Advice on Epidyolex (2020), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/861607/ACMD_advice_Epidyolex.pdf
    3. Kit Malthouse, Letter responding to the ACMD on Epidyolex scheduling and definition under the Misuse of Drugs Regulations 2001 (2020), https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/882901/Epidyolex_scheduling_and_definition_under_the_Misuse_of_Drugs_Regulations_2001.pdf
    4. National Institute for Health and Care Excellence, British National Formulary. Controlled drugs and dependence, Regulations and classification (2020), https://bnf.nice.org.uk/guidance/controlled-drugs-and-drug-dependence.html

    ADDITIONAL INFORMATION

    About GW Pharmaceuticals plc

    GW Pharmaceuticals (GW), and U.S. subsidiary Greenwich Biosciences, is a UK-based global biopharmaceutical company that has established a world-leading position in cannabinoid science and medicines. Founded over two decades ago in response to significant unmet patient need, patients remain our key focus and improving their quality of life, our motivation. GW's pioneering work has led to the regulatory approval of world first, potentially life changing, cannabis-based medicines. Our continued dedication has resulted in the treatment of thousands of patients with our medicines in the UK and around the world. For further information, please visit www.gwpharm.co.uk

    About EPIDIOLEX®/EPIDYOLEX® (cannabidiol)

    EPIDIOLEX®/EPIDYOLEX® (cannabidiol), the first prescription, plant-derived cannabis-based medicine approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and the European Medicines Agency's (EMA) for use in Europe, is an oral solution which contains highly purified cannabidiol (CBD). The medicine received approval in Europe in September 2019 for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older in conjunction with clobazam. GW's cannabidiol has received Orphan Drug Designation from the FDA and the EMA for the treatment of seizures associated with Dravet syndrome and LGS, both of which are severe childhood-onset, drug-resistant syndromes.

    Enquiries
    All investor and media enquiries


    UK, EU and ex-U.S. media enquiries
     
    Michael Trace / Ben Atwell, FTI Consulting+44 (0)203 727 1000


    Investor Relations
     
    Stephen Schultz, VP Investor Relations, GW+1 917 280 2424 / +1 401 500 6570


    U.S. media enquiries
     
    Sam Brown Inc Healthcare Communications 
    Christy Curran+1 615 414 8668
    Mike Beyer+1 312 961 2502

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  3. LONDON and CARLSBAD, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW or the Company)), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will host a virtual event for investors to provide a review of the U.S. development program and market opportunity for its late stage pipeline product, nabiximols. The program will be webcast live on June 30, 2020 from 10:00 am-12:00 pm EDT, and a replay will be available soon after the live presentation. Both the live webcast link and the archive will be available on GW's corporate website at www.gwpharm.com in the Investor section under Events and Presentations.

    Justin Gover, GW's Chief…

    LONDON and CARLSBAD, Calif., June 04, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW or the Company)), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that the Company will host a virtual event for investors to provide a review of the U.S. development program and market opportunity for its late stage pipeline product, nabiximols. The program will be webcast live on June 30, 2020 from 10:00 am-12:00 pm EDT, and a replay will be available soon after the live presentation. Both the live webcast link and the archive will be available on GW's corporate website at www.gwpharm.com in the Investor section under Events and Presentations.

    Justin Gover, GW's Chief Executive Officer, will host this event. The presentation will feature external medical and research experts as well as GW executives. 

    About Nabiximols
    Nabiximols is expected to enter pivotal Phase 3 development in the United States in the second half of 2020. The U.S. commercial rights are owned by GW. GW anticipates developing multiple indications for nabiximols with an initial focus on spasticity. The initial target indication in the U.S. will be for the treatment of MS spasticity, potentially to be followed by Spinal Cord Injury spasticity and Post Traumatic Stress Disorder, or PTSD.

    Nabiximols is a complex botanical medicine formulated from extracts of the cannabis plant that contains the principal cannabinoids THC and CBD and also contains minor constituents, including other cannabinoid and non-cannabinoid plant components, such as terpenes, sterols, and triglycerides. The product is administered as a mouth spray.

    Nabiximols is known as Sativex® outside of the United States and is licensed and commercially available for the treatment of MS spasticity in numerous countries. The efficacy of Sativex for MS spasticity has been demonstrated in multiple positive pivotal trials conducted in Europe1.

    1: Markova et al, International Journal of Neuroscience 2019; Novotna et al, European Journal of Neurology 2011; Collin et al, European Journal of Neurology 2007

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Enquiries:

    GW Pharmaceuticals plc  
    Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
       
       

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  4. LONDON and CARLSBAD, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group)), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that Justin Gover, GW's Chief Executive Officer, will present a business update at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10th, 2020 at 1:20pm EDT, which is being held virtually.

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

    About GW Pharmaceuticals plc and Greenwich Biosciences,

    LONDON and CARLSBAD, Calif., June 02, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH, GW, the Company or the Group)), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announced that Justin Gover, GW's Chief Executive Officer, will present a business update at the Goldman Sachs 41st Annual Global Healthcare Conference on Wednesday, June 10th, 2020 at 1:20pm EDT, which is being held virtually.

    A live audio webcast of the presentation will be available through GW's corporate website at www.gwpharm.com in the Investors section under Events & Presentations. A replay will be available soon after the live presentation.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.
    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism and schizophrenia. For further information, please visit www.gwpharm.com.

    Enquiries:

    GW Pharmaceuticals plc  
    Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570

     

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  5. - Total revenue of $120.6 million - 
    - Total Epidiolex® net product sales of $116.1 million - 
    - Conference call today at 4:30 p.m. EDT –

    LONDON and CARLSBAD, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces financial results for the first quarter ended March 31, 2020.

    "In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing…

    - Total revenue of $120.6 million - 
    - Total Epidiolex® net product sales of $116.1 million - 
    - Conference call today at 4:30 p.m. EDT –

    LONDON and CARLSBAD, Calif., May 11, 2020 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (NASDAQ:GWPH), a world leader in the science, development, and commercialization of cannabinoid prescription medicines, today announces financial results for the first quarter ended March 31, 2020.

    "In the first quarter of 2020, we have seen continued strength of the Epidiolex brand in both the U.S. and Europe and remain confident about prospects for growth in the remainder of the year. Having been granted priority review by the FDA for our proposed label expansion to include TSC, our US commercial team is actively preparing for the launch of this indication in August," stated Justin Gover, GW's CEO. "In this current environment caused by COVID-19, we have been able to support the epilepsy community remotely and maintain production of Epidiolex, while taking necessary steps to maintain the wellbeing of our employees. Looking ahead, GW is well placed to emerge strongly from the COVID-19 crisis with significant growth prospects for Epidiolex in the US and Europe, important pipeline clinical trials ready to execute, a strong balance sheet, and an unparalleled leading position in cannabinoid science."

    FINANCIAL RESULTS

    • Total revenue for the quarter ended March 31, 2020 was $120.6 million compared to $39.2 million for the quarter ended March 31, 2019
    • Net loss for the quarter ended March 31, 2020 was $8.0 million compared to a net loss of $50.1 million for the quarter ended March 31, 2019
    • Cash and cash equivalents at March 31, 2020 were $500.9 million compared to $536.9 million as of December 31, 2019

    OPERATIONAL HIGHLIGHTS

    • Epidiolex (cannabidiol) progress:
      • Total Q1 net product sales of Epidiolex of $116.1 million
      • U.S. commercial update
        • U.S. Epidiolex Q1 net product sales of $106.1 million
        • August commercial launch planned for TSC indication; July 31 PDUFA date
        • Epidiolex descheduled by the DEA
        • Payer discussions focused on pending TSC approval and expanding coverage
      • European commercial update
        • Successful commercial launches in Germany and UK
        • Important pricing & reimbursement progress in Germany & Italy. Commercial launches in France, Spain and Italy on track for later this year
        • TSC EMA submission accepted for review
      • Clinical progress with additional indications to broaden addressable market
        • Phase 3 trial in Rett Syndrome (recruitment temporarily on hold)
        • Several new formulations of CBD advancing into additional Phase 1 studies in 2020, including modified oral solution and capsule
      • Strengthening commercial exclusivity
        • Orphan exclusivity in both the U.S. and EU
        • 10 granted patents listed in Orange Book with expiry dates to 2035, including 1 patent recently granted broadly covering use in LGS and Dravet syndrome
        • Epidiolex composition patent application in process
        • 1 new allowed patent covering seizure sub-type use in Dravet syndrome expected to grant in Q2 2020
        • TSC patent applications under review with initial grant expected in 2020
    • Pipeline progress
      • Start of new clinical programs delayed until H2 2020 due to current COVID restrictions
      • Nabiximols (Sativex® outside of the US)
        • Multiple Sclerosis spasticity
          • US pivotal clinical program expected to commence in H2 2020 to augment existing data package
          • 3 positive Phase 3 trials completed in Europe
        • Spinal cord injury spasticity - clinical program expected to commence in H2 2020
        • PTSD – clinical program expected to commence in H2 2020
      • Schizophrenia (GWP42003)
        • Phase 2b trial expected to commence H2 2020
      • CBDV in autism
        • 30-patient open label study in autism
        • Investigator-led 100 patient placebo-controlled trial in autism
        • Open label study in Rett syndrome and seizures
      • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program commenced
        • Phase 1b safety study in patients continues to recruit due to emergency care environment
        • Orphan Drug and Fast Track Designations granted from FDA and EMA

    Conference Call and Webcast Information

    GW Pharmaceuticals will host a conference call and webcast today at 4:30 pm EDT. 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 Replay ID: 34479.

    About GW Pharmaceuticals plc and Greenwich Biosciences, Inc.

    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. The Company's lead product, EPIDIOLEX® (cannabidiol) oral solution, is commercialized in the U.S. by its U.S. subsidiary Greenwich Biosciences for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) or Dravet syndrome in patients two years of age or older. This product has received approval in the European Union under the tradename EPIDYOLEX®. The Company has submitted applications in both the U.S. and Europe to expand the indication for Epidiolex to include seizures associated with Tuberous Sclerosis Complex (TSC), for which it has reported positive Phase 3 data, and is carrying out a Phase 3 trial in Rett syndrome. The Company has a deep pipeline of additional cannabinoid product candidates, in particular nabiximols, for which the Company is advancing multiple late-stage clinical programs in order to seek FDA approval in the treatment of spasticity associated with multiple sclerosis and spinal cord injury, as well as for the treatment of PTSD. The Company has additional cannabinoid product candidates in Phase 2 trials for autism 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 EPIDIOLEX®/EPIDYOLEX® (cannabidiol) oral solution and Sativex® (nabiximols), and the safety profile and commercial potential of both medicines, and those associated with the COVID-19 pandemic, and those associated with the COVID-19 pandemic. 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 and uncertainties related to the regulatory process, and the acceptance of EPIDIOLEX®/EPIDYOLEX®, Sativex® 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.

    Enquiries:

    GW Pharmaceuticals plc  
    Stephen Schultz, VP Investor Relations 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
     

    Ex-U.S. media enquiries
     
    Ben Atwell, FTI Consulting +44 (0)203 727 1000


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    CONDENSED CONSOLIDATED BALANCE SHEETS
    (in thousands, except share data)
    (unaudited)

        March 31,     December 31,  
        2020     2019  
    Assets                
    Cash and cash equivalents   $ 500,935     $ 536,933  
    Accounts receivable, net     62,209       48,883  
    Inventory     89,056       85,528  
    Prepaid expenses and other current assets     20,546       28,292  
    Total current assets     672,746       699,636  
    Property, plant, and equipment, net     122,882       127,765  
    Operating lease assets     23,199       24,916  
    Intangible assets     5,951        
    Goodwill     6,959       6,959  
    Deferred tax assets     18,123       18,123  
    Other assets     4,517       4,850  
    Total assets   $ 854,377     $ 882,249  
    Liabilities and stockholders' equity                
    Accounts payable   $ 18,345     $ 9,990  
    Accrued liabilities     77,479       99,374  
    Current tax liabilities     998       437  
    Other current liabilities     6,650       7,760  
    Total current liabilities     103,472       117,561  
    Long-term liabilities:                
    Finance lease liabilities     5,157       5,573  
    Operating lease liabilities     20,028       21,650  
    Other liabilities     10,715       11,431  
    Total long-term liabilities     35,900       38,654  
    Total liabilities     139,372       156,215  
    Commitments and contingencies                
    Stockholders' equity:                
    Common stock - Ordinary shares par value £0.001;
      372,562,088 shares outstanding as of March 31, 2020;
      371,068,436 shares outstanding as of December 31, 2019
        573       570  
    Additional paid-in capital     1,643,407       1,632,046  
    Accumulated deficit     (845,924 )     (837,959 )
    Accumulated other comprehensive loss     (83,051 )     (68,623 )
    Total stockholders' equity     715,005       726,034  
    Total liabilities and stockholders' equity   $ 854,377     $ 882,249  


    GW PHARMACEUTICALS PLC
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (in thousands, except per share amounts)
    (unaudited)

        Three Months Ended
    March 31,
     
        2020     2019  
    Revenues                
    Product net sales   $ 120,532     $ 38,974  
    Other revenue     101       273  
    Total revenues     120,633       39,247  
    Operating expenses                
    Cost of product sales     10,769       5,131  
    Research and development     45,874       30,375  
    Selling, general and administrative     71,183       55,078  
    Total operating expenses     127,826       90,584  
    Loss from operations     (7,193 )     (51,337 )
    Interest income     1,269       2,087  
    Interest expense     (284 )     (265 )
    Foreign exchange loss     (20 )     (1,114 )
    Loss before income taxes     (6,228 )     (50,629 )
    Income tax expense (benefit)     1,737       (565 )
    Net loss   $ (7,965 )   $ (50,064 )
                     
    Net loss per share:                
    Basic   $ (0.02 )   $ (0.14 )
    Diluted   $ (0.02 )   $ (0.14 )
                     
    Weighted average shares outstanding:                
    Basic     373,831       369,823  
    Diluted     373,831       369,823  


    GW PHARMACEUTICALS PLC
    CONSOLIDATED STATEMENTS OF CASH FLOWS
    (in thousands)
    (unaudited)

        Three Months Ended March 31,  
        2020     2019  
    Cash flows from operating activities                
    Net loss   $ (7,965 )   $ (50,064 )
    Adjustments to reconcile net income (loss) to net cash used in
      operating activities:
                   
    Foreign exchange loss     60       797  
    Share-based compensation     11,361       11,142  
    Depreciation and amortization     2,656       2,417  
    Other     27        
    Changes in operating assets and liabilities:                
    Accounts receivable, net     (13,630 )     (14,998 )
    Inventory     (8,928 )     (14,295 )
    Prepaid expenses and other current assets     5,377       (874 )
    Other assets     885       659  
    Accounts payable     8,585       1,998  
    Current tax liabilities     1,726       (654 )
    Accrued liabilities     (16,953 )     6,328  
    Other liabilities     (1,799 )     (838 )
    Net cash used in operating activities     (18,598 )     (58,382 )
    Cash flows from investing activities                
    Additions to property, plant and equipment     (6,361 )     (12,087 )
    Additions to capitalized software     (535 )     (199 )
    Additions to intangible assets     (6,404 )      
    Net cash used in investing activities     (13,300 )     (12,286 )
    Cash flows from financing activities                
    Proceeds from exercise of stock options     3       773  
    Payments on finance leases     (73 )     (179 )
    Payments on landlord financing obligation     (143 )     (138 )
    Net cash (used in) provided by financing activities     (213 )     456  
    Effect of exchange rate changes on cash     (3,887 )     384  
    Net decrease in cash and cash equivalents     (35,998 )     (69,828 )
    Cash and cash equivalents at beginning of period     536,933       591,497  
    Cash and cash equivalents at end of period   $ 500,935     $ 521,669  
    Supplemental disclosure of cash flow information:                
    Income taxes paid     10       88  
    Interest paid     285       265  
    Supplemental disclosure of noncash information:                
    Property and equipment purchases in accounts payable and accrued liabilities     1,661       714  
    Right-of-use asset obtained in exchange for operating liabilities     275        

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