Epidiolex Growth Fuels GW Pharma Revenue Above Expectations to $120.6 Million

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GW Pharmaceuticals plc Reports First Quarter 2020 Financial Results and Operational Progress

– 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.

Justin Gover, GW’s CEO

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.

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: 615 414 8668
Mike Beyer: 312 961 2502

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

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