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

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.

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