GW Pharmaceuticals Pre-Announces Preliminary Unaudited Fourth Quarter and Full-Year 2019 Net Product Sales
January 12 2020 - 6:00PM
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,” said Justin Gover, GW’s
Chief Executive Officer. “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
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. GW’s lead product,
EPIDIOLEX® (cannabidiol) oral solution CV, is commercialized in the
US 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 expects to expand the indication of
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 statementsThis
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 CV and Sativex® (nabiximols), and the safety
profile and commercial potential of both medicines. 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 (U.S.) |
917 280 2424 / 401 500 6570 |
U.S. Media
Enquiries:Sam Brown Inc. Healthcare
Communications |
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Christy CurranMike Beyer |
615 414 8668312 961 2502 |
|
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UK, EU and ex-U.S. media enquiries |
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Ben Atwell, FTI Consulting |
+44 (0)203 727 1000 |
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