GW Pharma Releases Unaudited 2019 Results

GW Pharmaceuticals has provided preliminary, unaudited results for the fourth quarter of 2019 and the year as a whole.

GW Pharmaceuticals plc (Nasdaq: GWPH), the world leader in the science, development, and commercialization of cannabinoid prescription medicines, today reported preliminary, unaudited net product sales for the fourth quarter and full-year 2019 and key priorities for 2020. Justin Gover, GW's Chief Executive Officer expects to discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Tuesday, Jan. 14th at 11:00 a.m. PT (2:00 p.m. ET).

Our fourth quarter and full-year results for 2019 reflect an exceptional launch year for Epidiolex. We are proud of the positive impact this medicine has already had on thousands of patients and believe that this past year provides a compelling foundation for continued success in 2020. Justin Gover, GW's Chief Executive Officer.

Gover went on to say that "our goal in 2020 is not only to continue to drive Epidiolex growth but also to leverage our world leadership in cannabinoid science to advance our pipeline. In particular, we see significant market opportunity for nabiximols in several indications in the US and will be progressing multiple late stage clinical programs in 2020."

Preliminary Unaudited Fourth Quarter and Full-Year 2019 Net Product Sales

Based on preliminary unaudited financial information, the company expects total net product sales to be approximately $108 million for the fourth quarter and approximately $309 million for the year ended December 31, 2019. Total net product sales of Epidiolex are expected to be approximately $104 million for the fourth quarter and approximately $296 million for the full year. Cash and cash equivalents at December 31, 2019 were approximately $536 million. Fourth quarter and full-year 2019 financial results are expected to be reported on February 25th, 2020.

Key Priorities for 2020

EPIDIOLEX commercialization:

  • Continue to drive revenue growth:
    • Build on positive experiences from existing physicians to increase prescribing to appropriate patients
    • Accelerate adoption across a broader prescriber base
    • Work with U.S. commercial and government payors to ensure that appropriate patients have access to Epidiolex with as few restrictions as possible
    • Enter long-term care segment
    • Submit and obtain approval of the Tuberous Sclerosis Complex indication in both the U.S. and Europe, thereby significantly expanding the target population
    • Successful pricing and reimbursement, and launch execution, in the major five European countries (Germany, France, UK, Spain and Italy)
  • Supplement existing 9 Orange Book listed patents (expiry 2035) with additional use patents, and obtain grant of the Epidiolex "composition" patent
  • Advance the medical literature regarding Epidiolex through publications in top-tier medical journals and at major scientific and medical meetings, notably the American Academy of Neurology and American Epilepsy Society meetings

Nabiximols (known as "Sativex" outside US) in the US:

  • Commence pivotal clinical program in initial target indication of spasticity associated with Multiple Sclerosis
  • Commence clinical program to expand future label to include spasticity associated with Spinal Cord Injury
  • Commence clinical program in PTSD

Additional pipeline:

  • Commence Phase 2b study of a cannabidiol formulation for the treatment of schizophrenia
  • Continue to explore CBDV in autism through a combination of open-label and investigator-led placebo controlled clinical trials with data from one or more of these programs in 2020
  • Execute NHIE clinical program utilizing an intravenous formulation of cannabidiol

Note: Total Epidiolex sales include global sales of Epidiolex / Epidyolex

To learn more about GW Pharma, visit their company HQ here.

Disclaimer: Past performance is not an indicator of future performance.

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Louis O'Neill
Louis O'Neill

Louis is a writer based in Sydney with a focus on social and political issues. Having interviewed local politicians and entrepreneurs, Louis now focuses on cannabis culture, legislation & reform.

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