GW Pharma Exceeds Expectations with $108 Million Preliminary Unaudited Revenue in 4th Quarter

0
37
GW
Pharmaceuticals
Pre-Announces
Preliminary
Unaudited
Fourth
Quarter
and
Full-Year
2019
Net
Product
Sales

  • Total
    preliminary
    net
    product
    sales
    of
    approximately
    $108
    million
    for
    the
    fourth
    quarter
    and
    approximately
    $309
    million
    for
    the
    full
    year 

  • Total
    Epidiolex®
    preliminary
    net
    product
    sales
    of
    approximately
    $104
    million
    for
    the
    fourth
    quarter
    and
    approximately
    $296
    million
    for
    the
    first
    full
    year
    of
    sales

LONDON
and
CARLSBAD,
Calif.,
Jan.
12,
2020
(GLOBE
NEWSWIRE)


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

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
.


Original
press
release


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