Annual Report
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www.gwpharm.com
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Contents
01 Strategic Report
14 Directors’ Report
15 Directors’ Remuneration Report
34 Directors’ Responsibilities Statement
35 Independent Auditor’s Report
40 Consolidated Income Statements
40 Consolidated Statements of Comprehensive Loss
41 Consolidated Statement of Changes in Equity
42 Company Statement of Changes in Equity
43 Consolidated and Company Balance Sheets
44 Consolidated and Company Cash Flow Statements
45 Notes to the Consolidated Financial Statements
78 Advisers
www.gwpharm.com
Strategic Report
The Directors present their Strategic Report for the Group covering
the 15-month financial period ended 31 December 2018.
Our Marketed Products: Epidiolex
Strategy, Objectives and Business Model
Overview
We are a biopharmaceutical company focused on discovering,
developing and commercialising novel therapeutics from our
proprietary cannabinoid product platform in a broad range of
disease areas. In our 20 years of operations, we have established a
world-leading position in the development of plant-derived
cannabinoid therapeutics through our proven drug discovery and
development processes, our intellectual property portfolio and
regulatory and manufacturing expertise. Our lead cannabinoid
product is Epidiolex® oral solution, a pharmaceutical formulation
of cannabidiol (“CBD”), for which we retain global commercial
rights. Epidiolex was approved by the Food and Drug
Administration (“FDA”) on 25 June 2018 for the treatment of
seizures associated with Lennox-Gastaut syndrome, or LGS, or
Dravet syndrome, in patients two years of age and older. LGS and
Dravet syndrome are severe childhood-onset, drug-resistant
epilepsy syndromes. On 28 September 2018, the Drug
Enforcement Agency (“DEA”) placed Epidiolex in Schedule V, the
lowest restriction classification. Epidiolex became commercially
available in the US on 1 November 2018.
In Europe, we submitted an application for Epidiolex to the
European Medicines Agency’s, or EMA’s, Committee for Medical
Products for Human Use (“CHMP”) in December 2017, and we
expect an opinion from the CHMP on the application in the
second quarter of 2019. We have received Orphan Drug
Designation from the FDA for Epidiolex for LGS, Dravet
syndrome and tuberous sclerosis complex (“TSC”). We also
received Orphan Designation from the EMA’s Committee for
Orphan Medical Products (“COMP”) for Epidiolex for Dravet
syndrome, LGS, and TSC. We continue to develop Epidiolex for
additional indications, including the treatment of seizures
associated with TSC and plan to commence a pivotal trial in the
treatment of Rett syndrome.
Previously, we developed the world’s first plant-derived
cannabinoid prescription drug, Sativex® (nabiximols), which is
approved for the treatment of spasticity due to multiple sclerosis
in numerous countries outside the US. In the US, we met with the
FDA in December 2018 to discuss the optimal regulatory
pathway for US approval of Sativex and are now in the process of
planning a pivotal Phase 3 clinical trial, which we expect to start
in the fourth quarter of 2019.
We have a deep pipeline of additional cannabinoid product
candidates focusing primarily on orphan childhood-onset
neurologic conditions and oncology. Our pipeline includes
research in autism spectrum disorder (“ASD”) and Rett syndrome
using both CBD and cannabidivarin (“CBDV”). We reported
positive Phase 2 data for our CBD:THC product in the treatment
of glioblastoma multiforme. We have also reported positive Phase
2 data in schizophrenia. In addition, we have received Orphan
Drug Designation and Fast Track Designation from the FDA for
intravenous CBD for the treatment of Neonatal Hypoxic Ischemic
Encephalopathy (“NHIE”), for which a Phase 1 trial has been
completed.
Epidiolex in the United States
We launched Epidiolex on 1 November 2018 in the US market
after FDA approval for the treatment of seizures associated with
LGS or Dravet syndrome in patients two years of age and older.
The FDA confirmed orphan drug exclusivity for Epidiolex and
granted us a rare paediatric disease voucher. Following the
approval, DEA placed Epidiolex in Schedule V.
We have reported positive results from two LGS Phase 3 pivotal
trials, both achieving the primary endpoint of a median reduction
in monthly drop seizures compared with placebo. We have also
reported positive results from two Phase 3 pivotal trials in Dravet
syndrome. Epidiolex demonstrated an acceptable safety profile in
these Phase 3 pivotal trials. The Company’s development
programme represents the only well-controlled clinical evaluation
of a cannabinoid medication for patients with LGS and Dravet
syndrome.
LGS is a type of epilepsy with multiple types of seizures,
particularly tonic (stiffening) and atonic (drop) seizures. The
estimated prevalence of LGS is between 3% and 4% of childhood
epilepsy cases. LGS affects between 14,500 to 18,500 children
under the age of 18 years in the US and over 30,000 children and
adults in the US. Eighty percent of children with LGS continue to
experience seizures, psychiatric, intellectual and behavioural
deficits in adulthood. Seizures due to LGS are hard to control and
generally require life-long treatment.
Dravet syndrome is a severe infantile-onset, genetic, drug-
resistant epilepsy syndrome with a distinctive but complex
electroclinical presentation. Onset of Dravet syndrome occurs
during the first year of life with clonic seizures (jerking) and
tonic-clonic (convulsive) seizures in previously healthy and
developmentally normal infants. Symptoms peak at about five
months of age, and the latest onset beginning by 15 months of
age. Other seizures develop between one and four years of age
such as prolonged focal dyscognitive seizures and brief absence
seizures, and duration of these seizures decreases during this
period, but their frequency increases. Prognosis is poor, with
death occurring in approximately 14% of children. Patients
develop intellectual disability and life-long ongoing seizures.
Intellectual impairment varies from severe (50% of patients), to
moderate (25% of patients), to mild (25% of patients). Patients
rarely return to normal intellect.
Our US subsidiary, Greenwich Biosciences, markets Epidiolex
through an experienced commercial organisation consisting of
sales, medical affairs, marketing, and market access/payer teams.
Our medical affairs organisation has been in place for over two
years and includes 15 Medical Science Liaisons. Our US
marketing plan includes a combination of community neurology/
epilepsy meetings, patient advocacy events, an extensive
programme for US clinicians to share their Epidiolex experiences
and a media-based awareness programme.
01
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Strategic Report continued
We manufacture Epidiolex through utilisation of in-house and
external third-party facilities for various steps in the production
process. We have expanded various parts of the production
process both in-house and with external third parties in readiness
for commercial launch. As part of the New Drug Application
(“NDA”) review, the FDA pre-approval inspections of our
manufacturing facilities did not result in any Form 483
observations. We are continuing to expand our Epidiolex
manufacturing capacity in anticipation of post-US launch and
projected demand in Europe and elsewhere.
Epidiolex in Europe
In Europe, we submitted a marketing authorisation application in
December 2017 for both the Dravet syndrome and LGS indications.
In late November 2018, during the later stages of this review, the
second successful Phase 3 pivotal study in Dravet syndrome was
completed and the Company agreed with the regulatory authority
to add this data to the application. Fully integrating this data,
along with some necessary administrative Brexit-related changes,
now results in an expected EMA/CHMP opinion in the second
quarter of 2019. GW has recently initiated an Early Access
Programme in the five largest European countries in Europe,
enabling patients with the most immediate need to gain access.
We continue to make good progress for the commercialisation of
Epidiolex in Europe and are planning initial launches in the five
major European markets in 2019. Our commercial leadership team
is fully recruited and in place. This experienced team, which
includes several epilepsy disease experts, is focused on progressing
the necessary pricing and reimbursement, medical and pre-
commercial activities required to deliver a successful European
launch. In particular, significant progress is being made on
building the local country organisations in the five major European
markets. This first wave of local recruitment is very much focused
on leadership and medical staff. Medical affairs activities are
progressing well with national advisory boards now completed in
all the major markets and significant presence and data exposure at
key European and National Congresses.
Epidiolex Follow-On Target Indication: TSC
TSC is a genetic disorder that causes non-malignant tumours to
form in many different organs, primarily in the brain, eyes, heart,
kidney, skin and lungs. According to the Tuberous Sclerosis
Alliance, TSC is estimated to affect approximately 50,000
patients in the US. The most common symptom of TSC is
epilepsy, which occurs in 75 – 90% of patients, about 70% of
whom experience seizure onset in their first year of life.
Approximately 60% of these TSC patients (or approximately
25,000 of patients in the US) have treatment-resistant seizures.
We are progressing a Phase 3 trial of Epidiolex in patients with
TSC. This 210-person trial, which is fully recruited, is a 16-week
comparison of Epidiolex versus placebo to assess the safety and
efficacy of Epidiolex as an adjunctive anti-epileptic treatment.
Data from this trial is expected in the first half of 2019. Subject to
positive results, we expect to submit a supplemental NDA for
Epidiolex in TSC in the second half of 2019.
Epidiolex Follow-On Target Indication: Rett Syndrome
Rett syndrome (“RTT”) is a rare, non-inherited, X-linked
neurodevelopmental disorder affecting approximately 1 in 10,000
to 15,000 live female births. There are no approved treatments for
RTT. The management options target specific symptoms and are
not without undesirable side effects. As such, there is currently a
high unmet medical need. Data from animal models suggests
CBD may be able to improve deficits in cognition, language,
social behaviour and motor function, as well as having the
potential to modulate the cellular mechanisms thought to be
involved in the neurobehavioural deficits present in RTT.
A Phase 3 trial of Epidiolex in patients with RTT is expected to
start in the second quarter of 2019. It is an international multi-
centre, randomised, double-blind, placebo-controlled study to
investigate safety and efficacy.
Epidiolex Formulation Life Cycle Management
In addition to the Epidiolex formulation, we continue to develop
additional formulations of CBD as part of its life cycle
management plan. We are developing a capsule to provide more
convenient administration, particularly for adults and older
children across our target indications. We are also developing an
improved oral solution.
Our Marketed Products: Sativex
Sativex is an oromucosal spray of a formulated extract of the
cannabis sativa plant. We developed Sativex to be administered
as an oromucosal spray, whereby the active ingredients are
absorbed in the lining of the mouth, either under the tongue or
inside the cheek. At this time, we have received regulatory
approval for Sativex in numerous countries outside the US.
Sativex in the US
In December 2017, we terminated our license agreement with
Otsuka Pharmaceutical Co., Ltd., in relation to Sativex in the US
and we have reacquired full ownership of the development and
commercialisation rights to the product in the US. In the US,
we met with the FDA in December 2018 to discuss the optimal
regulatory pathway for US approval of Sativex and are now in
the process of planning a pivotal Phase 3 clinical trial, which
we expect to commence in the fourth quarter of 2019.
Beyond an initial target US indication of MS spasticity, we believe
that Sativex has significant additional market potential. We have
completed over 10 placebo-controlled trials and believe there is
the potential for future development of multiple indications.
Sativex in Europe
To support the development and commercialisation of Sativex in
Europe, we have license and development agreements with the
following major pharmaceutical companies: Almirall S.A., or
Almirall, in Europe (excluding the UK) and Mexico; Bayer
HealthCare AG, or Bayer, in the UK and Canada; Ipsen Biopharm
Ltd, or Ipsen, in Latin America (excluding Mexico and the
Islands of the Caribbean); and Neopharm Group, or Neopharm,
in Israel. These agreements provide our collaborators with the
sole right to commercialise Sativex in exclusive territories for all
indications.
Sativex Intellectual Property
Our strategy is to seek and obtain patents related to Sativex
across all major pharmaceutical markets around the world. In the
US, our patents (and our pending applications if they issue)
relating to Sativex would expire on various dates between 2021
02
GW Pharmaceuticals plc | Annual Report and Accounts 2018 and 2029, excluding possible patent term extensions. We have
at least seven different patent families containing one or more
pending and/or issued patents directed to the Sativex
formulation, the extracts from which Sativex is composed, the
extraction technique used to produce the extracts and the
therapeutic use of Sativex.
Proprietary Cannabinoid Product Platform
We have established a world-leading position in cannabinoid
therapeutics through our proven proprietary cannabinoid
product platform. Our platform consists of a continually evolving
library of internally generated novel cannabis plant types that
produce selected cannabinoids, discovery of novel cannabinoid
pharmacology through our network of world-leading scientists,
a global intellectual property portfolio, in-house formulation,
processing and manufacturing capabilities, and development and
regulatory expertise. We further believe that we are in a unique
position to develop and manufacture plant-derived cannabinoid
formulations worldwide at sufficient quality, uniformity, scale
and sophistication for the purposes of pharmaceutical
development and to meet international regulatory requirements.
The cannabis plant is the unique source of more than 70
structurally related, plant-derived cannabinoids. Although one
cannabinoid, THC, is known to cause psychoactive effects
associated with the use of illicit herbal cannabis, none of the
other cannabinoids are known to share this property. In recent
decades, there have been major scientific advances that have led
to the discovery of new plant-derived cannabinoids and a
cannabinoid receptor system in the human body, or
endocannabinoid system. We are at the forefront of this new area
of science, and we believe that our proprietary cannabinoid
product platform uniquely positions us to discover and develop
cannabinoids as new therapeutics.
Our proprietary cannabinoid product platform consists of our:
> continually evolving library of internally generated novel
cannabis plant types that produce selected cannabinoids, or
chemotypes. We can reproduce the selected chemotypes
through propagation of plant cuttings, or clones, in order to
ensure that all subsequent plant material is genetically
uniform. We can also generate seeds of selected chemotypes
for large-scale production;
> in-house extraction, processing methodologies and analytical
techniques, which yield well-characterised and standardised
chemotype extracts;
> discovery of novel cannabinoid pharmacology through
conducting pharmacologic evaluation studies in validated
disease models to determine the most promising potential
therapeutic areas for each extract;
> in-house formulation and manufacturing capabilities,
supplemented by third-party contractors;
> global in-house development and regulatory expertise; and
> intellectual property portfolio, which includes issued and/or
pending claims directed to plants, plant extracts, extraction
technology, pharmaceutical formulations, drug delivery and
the therapeutic uses of cannabinoids, as well as plant variety
rights, know-how and trade secrets.
With the exception of Sativex, which is subject to licensing
agreements described above, we retain global commercial rights
to all of our product pipeline candidates.
Pipeline Summary
Epilepsy and Paediatric Neurology
Product/Product
Candidates
Epidiolex
(“CBD”)
Indication
Partner(s)
Status
Expected Next Steps
Childhood-onset epilepsy We retain global rights.
Approved by the FDA
and launched in the US.
Initial targets:
Treatment of seizures in
LGS and Dravet syndrome
in patients two years of age
and older.
Additional targets: TSC
Rett syndrome
Under review by EMA
in Europe.
CHMP opinion expected
in Q2 2019.
Phase 3 trial in TSC
fully recruited.
Data from Phase 3 TSC
trial expected in H1 2019.
Subject to positive results,
sNDA in H2 2019.
IND for pivotal trial
submitted. Trial expected
to commence H1 2019.
03
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Strategic Report continued
Product/Product
Candidates
GWP42006
(CBDV)
Indication
ASD
Rett syndrome
Epilepsy
Partner(s)
Status
Expected Next Steps
We retain global rights.
Company-sponsored
IND submitted Nov.
2018. Investigator-led
placebo-controlled trial
in autism; expanded
access IND to treat
seizures associated with
autism underway.
Investigator-led Phase 2
open label trial in Rett
syndrome.
FDA orphan designation
in Rett syndrome.
Phase 2a trial
completed.
Company-sponsored
open-label trial expected
to commence H1 2019.
Investigator-led placebo-
controlled trial expected to
commence H1 2019.
Trial expected to
commence H1 2019.
Under evaluation.
Intravenous
GWP42003
Neonatal hypoxic-ischemic
encephalopathy
We retain global rights.
Phase 1 trial in healthy
volunteers complete.
Phase 2 trial due to
commence 2019.
Other Pipeline Candidates
Product/Product
Candidates
Sativex
(nabiximols)
Indication
Partner(s)
Status
Expected Next Steps
MS spasticity (ex-US)
Almirall, Bayer, Ipsen
and Neopharm.
Approved in numerous
countries.
MS spasticity (US)
We retain rights.
Neuropathic pain/other
neurological symptoms
Combination of
CBD and THC
Glioblastoma
We retain global rights.
Pivotal Phase 3 trial
expected to commence in
Q4 2019.
Pivotal programme in
planning.
Pivotal clinical programme
under evaluation.
FDA meeting completed
in December 2018.
Multiple placebo-
controlled trials
completed.
Phase 2 trial complete
and reported in
February 2017.
Data presented at
ASCO. FDA orphan
designation.
GWP42003
Schizophrenia
We retain global rights.
Positive Phase 2 proof-
of-concept.
Phase 2b trial under
evaluation.
04
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Business Strategy
Our goal is to capitalise on our leading position in the field
of plant-derived cannabinoid therapeutics by pursuing the
following strategies:
> Commercialise our lead product candidate Epidiolex in Dravet
syndrome and LGS in the US and Europe using our own
commercial organisation, and to identify the optimal
commercial pathway in other markets around the world.
> Expand the market opportunity for Epidiolex within the field
of epilepsy and Rett syndrome.
> Seek US approval for Sativex, commercialise Sativex in the US
using our own commercial organisation, and expand the
Sativex market to new indications.
> Advance several clinical-stage proprietary cannabinoid
product candidates to late-stage development.
> Leverage our proprietary cannabinoid product platform and
world-leading position to discover, develop and commercialise
additional novel first-in-class cannabinoid products.
> Further strengthen our lead competitive position.
Review of the Business
The Group has changed its year-end to 31 December, and this is the
first set of financial statements adopting the new year-end date. We
are reporting for the 15-month period ended 31 December 2018.
The Group has also elected to convert its presentational currency
to US Dollars to be consistent with our external financial reports
to the United Securities and Exchange Commission, as required
by our listing on NASDAQ. The Group additionally reassessed
the functional currency of its Group companies and considered
that the Group’s top company, GW Pharmaceuticals plc, had a
functional currency of US Dollars with effect from 1 July 2018.
To enable prior period comparisons, we are also reporting pro
forma unaudited results for the 12-month period ended
31 December 2018 and comparatives for the 12-month period
ended 31 December 2017 (referred to here as 2018 and 2017
respectively). The unaudited results have been prepared using the
same accounting policies and procedures as the audited results.
We believe that the presentation of these unaudited results is also
representative of the performance in the 15-month period to
31 December 2018. Any deviations from this are explained below.
The below results include the implementation of IFRS 15 Revenue
from Contracts with Customers during the 15-month period and
year to 31 December 2018. The results below for the three months
and year to 31 December 2017 do not include the impact of this
implementation.
Revenue
Cost of sales
Research and development expenditure
Sales, general and administrative expenses
Net foreign exchange (loss)/gain
Operating loss
Interest expense
Interest and other income
Loss before tax
Tax benefit
Loss for the period
Revenue
Cost of sales
Research and development expenditure
Sales, general and administrative expenses
Net foreign exchange (loss)/gain
Operating loss
Interest expense
Interest and other income
Loss before tax
Tax benefit
Loss for the period
A
15 months to
31 December 2018
(audited)
$000s
B
Unadjusted 3 months
to 31 December 2017
(unaudited)
$000s
C
IFRS 15 adoption
31 December 2017
(unaudited)
$000s
B–C
Adjusted
3 months to
31 December 2017
(unaudited)
$000s
A–(B–C)
12 months to
31 December 2018
(unaudited)
$000s
12 months to
31 December 2017
(unaudited)
$000s
19,391
(7,912)
(167,142)
(187,602)
(2,666)
(345,931)
(1,573)
11,155
(336,349)
(5,090)
(341,439)
7,728
(1,190)
(40,818)
(23,445)
(3,442)
(61,167)
(320)
1,621
(59,866)
(3,433)
(63,299)
(3,716)
–
–
–
–
(3,716)
–
–
(3,716)
–
(3,716)
4,012
(1,190)
(40,818)
(23,445)
(3,442)
(64,883)
(320)
1,621
(63,582)
(3,433)
15,379
(6,722)
(126,324)
(164,157)
776
(281,048)
(1,253)
9,534
(272,767)
(1,657)
15,709
(4,828)
(152,088)
(68,438)
(24,467)
(234,112)
(1,160)
3,347
(231,925)
19,732
(67,015)
(274,424)
(212,193)
A
3 months to
31 December 2016
(unaudited)
$000s
B
12 months to
30 September 2017
(audited)
$000s
C
3 months to
31 December 2017
(unaudited)
$000s
B–A+C
12 months to
31 December 2017
(unaudited)
$000s
2,538
(883)
(30,752)
(8,250)
14,583
(22,764)
(111)
337
(22,538)
3,287
10,519
(4,521)
(142,022)
(53,243)
(6,442)
(195,709)
(951)
2,063
(194,597)
26,452
7,728
(1,190)
(40,818)
(23,445)
(3,442)
(61,167)
(320)
1,621
(59,866)
(3,433)
15,709
(4,828)
(152,088)
(68,438)
(24,467)
(234,112)
(1,160)
3,347
(231,925)
19,732
(19,251)
(168,145)
(63,299)
(212,193)
05
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Strategic Report continued
Revenue
Total revenue for the year ended 31 December 2018 was
$15.4 million, compared to $15.7 million for the year ended
31 December 2017. The decrease of $0.3 million comprises:
> An increase of $6.3 million in product sales to $14.8 million
for the year ended 31 December 2018, compared to $8.5
million for the year ended 31 December 2017. This was driven
by:
– The recording of $4.7 million in Epidiolex product sales
revenues following the product launch in the United States
in November 2018.
– A $1.6 million increase in Sativex product sales revenues to
$10.1 million due to increased shipments to partners.
In-market sales volumes sold by GW’s commercial partners
for the year ended 31 December 2018 were 16% higher than
the year ended 31 December 2017.
> A $4.9 million decrease in licence, collaboration and technical
access fees following the adoption of IFRS 15 in the period.
This has resulted in the acceleration of all previously-
unrecognised deferred fee income.
> A $1.8 million decrease in research and development fee
income to $0.4 million compared to $2.2 million for the year
ended 31 December 2017. This reflects the continued
reduction of rechargeable activity associated with our prior
collaboration with Otsuka, which ended in December 2017.
> A $0.1 million decrease in development and approval
milestones.
The explanations above are also representative of the increase of
$8.9 million to $19.4 million for the 15-month period ended
31 December 2018 compared to $10.5 million for the year ended
30 September 2017.
Cost of Sales
Cost of sales for the year ended 31 December 2018 of $6.7 million
represents an increase of $1.9 million compared to the $4.8
million recorded in the year ended 31 December 2017. This
increase reflects the launch of Epidiolex in the United States as
well as the growth in the volume of Sativex inventory shipped to
commercial partners in the current period.
Research and Development Expenditure
Total R&D expenditure for the year ended 31 December 2018 of
$126.3 million decreased by $25.8 million compared to the
$152.1 million incurred in the year ended 31 December 2017.
The most significant driver for the decrease in R&D expenditure
is the commencement of capitalisation of Epidiolex inventory
onto the balance sheet. The Group determined that the successful
acceptance by the Federal Drug Administration (FDA) for
Epidiolex in the United States in December 2017 triggered the
commencement of capitalisation of inventory; prior to this date,
all high CBD plant material and associated production costs were
expensed as R&D.
From 1 January 2018 onwards, manufacturing and associated
production costs were absorbed into inventory and capitalised
onto the balance sheet, with a full provision against this material.
This inventory was fully provided for until the point of product
approval, which occurred in June 2018. The closing Epidiolex
inventory balance as at 31 December 2018 was $44.4 million.
06
Sales, General and Administrative Expenses
Sales, general and administrative expenses for the year ended
31 December 2018 of $164.2 million increased by $95.8 million
compared to the $68.4 million incurred in the year ended
31 December 2017. This net increase is due to the launch of
Epidiolex in the United States in November 2018, which included
the hiring of an internal salesforce, finalising infrastructure and
commercialisation processes required for a company marketing
its own product in the United States for the first time.
Additionally, the Group continues to hire key business leads and
positions in Europe ahead of potential launches in 2019.
The explanations above are also representative of the increase of
$134.4 million to $187.6 million for the 15-month period ended
31 December 2018 compared to $53.2 million for the year ended
30 September 2017.
Net Foreign Exchange Gains/(Losses)
Net foreign exchange movements resulted in a $0.8 million gain for
the year ended 31 December 2018 compared to a $24.5 million loss
for the year ended 31 December 2017. This foreign exchange gain
mostly arises from unrealised gains on our US Dollar denominated
cash deposits upon retranslation at the closing balance sheet
exchange rate.
Interest Expense
Interest expense of $1.3 million for the year ended 31 December
2018 increased by $0.1 million compared to the $1.2 million
recorded for the year ended 31 December 2017. This increase
reflects an increase in interest paid on leases for manufacturing
facilities and interest on repayments of the fit-out funding
previously received.
Interest and Other Income
Interest and other income increased by $6.2 million to $9.5
million for the year ended 31 December 2018 compared to $3.3
million for the year ended 31 December 2017. This increase
reflects the recognition of the Group’s expected R&D large
company tax credit claim (“RDEC”) in respect of the statutory
15-month period ended 31 December 2018. Previously the Group
was eligible to claim R&D tax credits under the Small and
Medium Enterprise (“SME”), and these were classified within
Tax Benefit. The additional increase reflects growth in interest
income earned on the Group’s cash and cash equivalents balance
throughout the period.
Tax
Our tax benefit decreased by $21.4 million to a $1.7 million charge
for the year ended 31 December 2018 compared to $19.7 million
benefit for the year ended 31 December 2017. As noted in “Interest
and Other Income” above, this previously included the Group’s
SME R&D tax claim for which the Group is no longer eligible.
The explanation above is also representative of the decrease of
$31.6 million to a $5.1 million charge for the 15-month period
ended 31 December 2018 compared to a $26.5 million benefit for
the year ended 30 September 2017.
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Consolidated Balance Sheet
The following information is on an “as reported” basis as noted
on the Consolidated Income Statement shown on page 40, and
illustrates the movement from the end of the balance sheet
periods of 30 September 2017 to 31 December 2018.
Property, plant and equipment
Property, plant and equipment increased by $31.1 million to
$89.4 million at 31 December 2018 compared to $58.3 million
at 30 September 2017. This reflects the Group’s continuing
investment in expansion of our cannabinoid extraction and
production facilities in the United Kingdom.
Inventories
Total inventories increased by $45.3 million to $51.0 million at
31 December 2018 compared to $5.7 million at 30 September
2017. This increase is due to the commercialisation of Epidiolex.
Effective from 1 January 2018, costs associated with producing
Epidiolex commercial inventory were capitalised as an asset to
the balance sheet but fully-provided against. Upon approval from
the FDA in June 2018, this provision was reversed to the extent
that the material was supportable by sales forecasts, as the
uncertainty surrounding the recoverability of this inventory had
been removed.
Cash and cash equivalents
Total cash and cash equivalents increased by $269.3 million to
$591.5 million at 31 December 2018 compared to $322.2 million
at 30 September.
> Total net cash outflow from operating activities for the 15
months to 31 December 2018 was $301.4 million, representing
the operating expenditure of the organisation and
commercialisation scale-up activities.
> Total net cash inflow from financing activities was $620.8
million, representing the completion of two public offerings on
NASDAQ in December 2017 and October 2018, raising a
combined total of $622.5 million (net) after expenses.
> Total cash outflow from investing activities was a net
$41.4 million, predominantly driven by capital expenditure
associated with the construction of our manufacturing
facilities.
Subsequent to the period end date, the Group completed the sale
of a Rare Pediatric Disease Priority Review Voucher for $105.0
million. See Note 28 for further details.
Trade and other payables
Total current trade and other payables increased by $19.4 million
to $63.6 million at 31 December 2018 compared to $44.2 million
at 30 September 2017. This increase reflects the scale-up of the
Group’s operations following Epidiolex commercial launch in
November 2018, and additional organisation costs associated
with preparation for European commercialisation.
Deferred revenue
Total deferred revenue has decreased to $nil at 31 December 2018
compared to $8.8 million at 30 September 2017. This is following
the adoption of IFRS 15 Revenue from Contracts with Customers
which has resulted in the acceleration of previously unrecognised
deferred income. More information is presented in Note 2 to the
financial statements.
Our Key Business Trends
The following information provides a summary of the
development and performance of the Company’s business during
the 15-month period and the position of the business as at
31 December 2018.
We have elected to provide unaudited calendar year figures to
provide the maximum information to shareholders, and this
aligns with the Group’s amended accounting reference date of
31 December.
The Group considers that the primary key performance indicator
is the progress on the regulatory approval, rescheduling and sales
volumes of Epidiolex in the US and around the world. The
progress of regulatory filings and product launches are not easily
quantifiable, but best represents the Group’s progress during
2018.
Revenue
Our revenues consist of product sales revenues, R&D fees,
licence, collaboration and technical access fees and development
and approval milestone fees.
The trend analysis below reflects the impact of the adoption of
IFRS 15 Revenue from Contracts with Customers and assumes
that revenue accounting under IFRS 15 had been in place since
1 October 2014. The impact of this removes any license,
collaboration and technical access fee for the years ended
31 December 2016, 2017 and 2018.
For the year ended 31 December 2018, we recorded revenues
of $15.4 million, an increase of $4.6 million or 42% from the
$10.8 million recorded for the year ended 31 December 2017.
> In the year to 31 December 2018 we saw the commercial
launch of Epidiolex, recording revenue of $4.7 million. This is
the Group’s first own commercial product, and first marketed
into the United States
> We recorded Sativex product sales revenue of $10.1 million in
the year ended 31 December 2018, an increase of $1.6 million
from the $8.5 million recorded in the year ended 31 December
2017. This is supported by strong performance in market,
particularly in Germany. In-market sales made by our
commercial partners increased by 16%
> We have seen a continued decline in our R&D fee income to
$0.4 million compared to $1.8 million for the year ended
31 December 2017. This reflects the conclusion of rechargeable
activity associated with our prior collaboration with Otsuka,
which ended in December 2017.
We see product sales as the key driver for the Group, following
the launch of Epidiolex in the United States in November 2018.
07
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Strategic Report continued
Total Group Revenue ($000s)
Year ended 31 December
60,000
50,000
40,000
30,000
20,000
10,000
0
2014
2015
2016
2017
2018
Development
and approval
milestone fees
License,
collaboration
and technical
access fees
Research and
Development
fees
Product sales
Number of Countries Sold to In-Market
The Number of Countries Sold to In-Market graph below primarily
illustrates the in-market commercial sales volumes of Sativex® by
our commercial marketing partners Bayer in the United Kingdom
and Canada, Almirall in Europe, Neopharm in Israel and Ipsen in
South America. This also includes the impact of the launch of
Epidiolex in the United States from 1 November 2018.
In total, the number of countries sold to in-market grew from 16
countries at 31 December 2017, to 20 countries at 31 December
2018. In the period, the first in-market sales were made
predominantly in South American territories, including Brazil,
Chile and Colombia via our marketing partner, Ipsen, as well as
our first launch of Epidiolex into the United States.
As at 31 December 2014, commercial sales were present in
thirteen territories. In 2015, Almirall launched Sativex in
Belgium. In 2017 we launched in New Zealand and Australia
following the return of the rights for Sativex® from Novartis.
We expect the growth of Epidiolex sales markets, subject to
approval, to be the key driver in this trend for future years.
Number of Countries Sold to In-Market
As at 31 December
Total Group Expenditure
As illustrated in the Total Group Expenditure graph below, our
R&D expenditures have shown a consistent growth trend over
the last five financial years from $71.3 million in 2014 to $152.1
million in 2017. This increase reflected the Phase 3 clinical
research with Epidiolex, progress with other pipeline product
candidates and scale up of R&D activities associated with our
growing programmes.
The decline to $126.3 million in 2018, a decrease of
$25.8 million, is due to the absorption of costs associated with
inventory previously expensed as R&D which were eligible for
capitalisation once sufficient certainty of product approval had
been received from the FDA. Inventory recognition commenced
from 1 January 2018.
Sales, general and administrative expenditure has increased from
$9.4 million in 2014, from when all of the Group’s external
commercial sales were conducted through partners, to $164.2
million in 2018. The increase of $95.8 million from $68.4 million
in 2017 to $164.2 million reflects the completion of the full
commercial organisation in place in the United States to support
the commercial launch of Epidiolex on 1 November, as well as the
significant investment in pre-launch activities in Europe.
Total Group Expenditure ($000s)
Year ended 31 December
h
s
a
C
p
u
o
G
g
n
s
o
C
r
i
l
Total R&D
Total SG&A
350,000
300,000
250,000
200,000
150,000
100,000
50,000
0
2014
2015
2016
2017
2018
25
20
15
10
5
0
2014
2015
2016
2017
2018
t
e
k
r
a
m
n
-
i
,
o
t
l
d
o
s
s
e
i
r
t
n
u
o
C
08
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Group Cash
The graph below illustrates the trend in our 31 December closing
cash position for each of the last five years.
Closing Group Cash ($000s)
As at 31 December
h
s
a
C
p
u
o
G
g
n
s
o
C
r
i
l
700,000
600,000
500,000
400,000
300,000
200,000
100,000
0
2014
2015
2016
2017
2018
Since our listing on NASDAQ in May 2013, having taken the
decision to invest in the development of Epidiolex to treat a
number of refractory forms of childhood onset epilepsy we have
consistently recorded operating cash outflows, offset by the
proceeds of a series of fundraisings, each of which have been
conducted following the achievement of key product development
milestones. Our aim has been to ensure that the Group remains
well funded with sufficient working capital to successfully
execute our Epidiolex and other pipeline product development
plans. Consequently, we have completed at least one equity
fundraising in each of 2014 through to 2018, to help execute this
strategy.
During 2018 we completed a public offering of 26,220,000
ordinary shares of the Company on the NASDAQ Global Market,
raising net proceeds after underwriting discounts and
commissions of $324.6 million.
We believe that we are suitably well-funded to execute on our US
Epidiolex launch, prepare for European commercialisation and
continue our life cycle and clinical development programmes.
Principal Risks and Uncertainties
In common with other pharmaceutical development companies,
GW faces a number of risks and uncertainties. Internal controls are
in place to help identify, manage and mitigate these risks. A Risk
Committee has been established who, based upon input from
programme directors, functional heads and subject matter experts,
prepare a risk matrix outlining the status of risks, mitigating controls
and action plans. This matrix is reviewed by the Board of the
Company as part of their annual assessment of the principal risks
and risk management controls.
Further details of risk factors considered by GW for the 15-month
period ended 31 December 2018 are included on Form 10-KT which
was filed with the US Securities and Exchange Commission on
27 February 2019. The risks have been identified as follows:
Marketing and Commercialisation
> Our prospects are highly dependent on the successful
commercialisation of Epidiolex.
> If we do not obtain regulatory approval of Epidiolex for other
indications in the US, or for any indications in foreign
jurisdictions, we will not be able to market Epidiolex for other
indications or in other jurisdictions, which will limit our
commercial revenues.
> Our FDA approval subjects us to ongoing obligations and
continued regulatory review, which may result in significant
additional expense and, if we do not meet those ongoing
obligations, we could be subject to significant penalties,
including market withdrawal and/or civil or criminal penalties.
> Epidiolex has only been studied in a limited number of
patients and in limited populations. As we continue our
commercial launch, Epidiolex will become available to a much
larger number of patients, and we do not know whether the
results of Epidiolex use in such larger number of patients will
be consistent with the results from our clinical trials.
> We have limited marketing experience, and have only recently
established our sales force, distribution and reimbursement
capabilities, and we may not be able to successfully
commercialise Epidiolex, or any of our product candidates if
they are approved in the future.
> Our product candidates, if approved, may be unable to achieve
the expected market acceptance and, consequently, limit our
ability to generate revenue from new products.
> We expect to face intense competition, often from companies
with greater resources and experience than we have.
> Product shipment delays could have a material adverse effect
on our business, results of operations and financial condition.
> If the price for Epidiolex, Sativex or any future approved
products decreases or if governmental and other third-party
payers do not provide adequate coverage and adequate
reimbursement levels, our revenue and prospects for
profitability will suffer.
> Counterfeit versions of our products could harm our business.
> Our existing collaboration arrangements and any that we may
enter into in the future may not be successful, which could
adversely affect our ability to develop and commercialise
Epidiolex, Sativex and our product candidates.
09
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Strategic Report continued
Clinical
> We are dependent on the success of our product candidates,
some of which may not receive regulatory approval or be
successfully commercialised.
> Clinical trials for our product candidates are expensive,
time-consuming, uncertain and susceptible to change, delay or
termination. The results of clinical trials are open to differing
interpretations.
> Information obtained from expanded access studies may not
reliably predict the efficacy of our product candidates in
Company-sponsored clinical trials and may lead to adverse
events that could limit approval.
> There is a high rate of failure for drug candidates proceeding
through clinical trials.
Regulatory and Legislative
> Epidiolex, Sativex and our product candidates contain
controlled substances, the use of which may generate public
controversy.
> The development of a REMS for Epidiolex or our product
candidates could cause delays in the approval process and
would add additional layers of regulatory requirements that
could impact our ability to commercialise our product
candidates in the US and reduce their market potential.
> Controlled substance legislation differs between countries and
legislation in certain countries may restrict or limit our ability
to sell Epidiolex, Sativex and our product candidates.
> Epidiolex is and the product candidates we are developing will
be subject to US controlled substance laws and regulations and
failure to comply with these laws and regulations, or the cost
of compliance with these laws and regulations, may adversely
affect the results of our business operations, both during
clinical development and post approval, and our financial
condition.
> If one of our product candidates is approved and classified as a
Schedule II controlled substance, federal law may impose
additional restrictions on importation for commercial
purposes.
> If product liability lawsuits are successfully brought against
> The legalisation and use of medical and recreational marijuana
us, we will incur substantial liabilities and may be required to
limit the commercialisation of Epidiolex, Sativex and our
product candidates.
> Our employees may engage in misconduct or other improper
activities, including noncompliance with regulatory standards
and requirements.
> If we are unable to use net operating loss carry-forwards and
certain built-in losses to reduce future tax payments, or benefit
from favourable tax legislation, our business, results of
operations and financial condition may be adversely affected.
> We are subject to the UK Bribery Act, the US Foreign Corrupt
Practices Act and other anti-corruption laws, as well as export
control laws, customs laws, sanctions laws and other laws
governing our operations. If we fail to comply with these laws,
we could be subject to civil or criminal penalties, other
remedial measures, and legal expenses, which could adversely
affect our business, results of operations and financial
condition.
> Our proprietary information, or that of our customers,
suppliers and business partners, may be lost or we may suffer
security breaches.
> Legislative or regulatory reform of the health care system in
the US and foreign jurisdictions may affect our ability to
profitably sell our products, if approved.
> We expect additional federal and state legislative proposals for
health care reform, which could limit the prices that can be
charged for the products we develop and may limit our
commercial opportunity.
> Any failure by us to comply with existing regulations could
harm our reputation and operating results.
in the US and elsewhere may impact our business.
Orphan Drug Designation and Intellectual Property
> In respect of our product candidates targeting rare indications,
orphan drug exclusivity may afford limited protection, and if
another party obtains orphan drug exclusivity for the drugs
and indications we are targeting, we may be precluded from
commercialising our product candidates in those indications
during that period of exclusivity.
> We may not be able to adequately protect Epidiolex, Sativex,
our product candidates or our proprietary technology in the
marketplace.
> If third parties claim that intellectual property used by us
infringes upon their intellectual property, our operating profits
could be adversely affected.
Manufacturing and Technology
> Problems in our manufacturing process, failure to comply with
manufacturing regulations or unexpected increases in our
manufacturing costs could harm our business, results of
operations and financial condition.
> We may fail to expand our growing and manufacturing
capability in time to meet market demand for our products
and product candidates, and the FDA may refuse to accept
our facilities or those of our contract manufacturers as being
suitable for the production of our products and product
candidates.
> Product recalls or inventory losses caused by unforeseen
events, cold chain interruption and testing difficulties may
adversely affect our operating results and financial condition.
> We are subject to federal, state and foreign healthcare laws and
> Business interruptions could delay us in the process of
regulations and implementation of or changes to such
healthcare laws and regulations could adversely affect our
business and results of operations.
> If we are found in violation of federal or state “fraud and
abuse” laws, we may be required to pay a penalty and/or be
suspended from participation in federal or state health care
programmes, which may adversely affect our business,
financial condition and results of operations.
> Our ability to research, develop and commercialise Epidiolex,
Sativex and our product candidates is dependent on our ability
to maintain licenses relating to the cultivation, possession and
supply of controlled substances.
10
developing our product candidates and could disrupt our
product sales.
> Failure of our information technology systems, including
cybersecurity attacks or other data security incidents, could
significantly disrupt the operation of our business.
> Security breaches, loss of data and other disruptions could
compromise sensitive information related to our business,
prevent us from accessing critical information or expose us to
liability, which could adversely affect our business and our
reputation.
GW Pharmaceuticals plc | Annual Report and Accounts 2018 > We depend on a limited number of suppliers for materials and
components required to manufacture Epidiolex, Sativex and
our product candidates. The loss of these suppliers, or their
failure to supply us on a timely basis, could cause delays in our
current and future capacity and adversely affect our business.
Safety
> Serious adverse events or other safety risks could require us to
abandon development and preclude, delay or limit approval of
our product candidates, limit the scope of any approved label
or market acceptance, or cause the recall or loss of marketing
approval of products that are already marketed.
Staffing
> If we are unable to effectively train and equip our sales force,
our ability to successfully commercialise Epidiolex may be
harmed.
> We have recently grown our business and will need to further
increase the size and complexity of our organisation in the
future, and we may experience difficulties in managing our
growth and executing our growth strategy.
> We depend upon our key personnel and our ability to attract
and retain employees.
Funding and Operational
> We have significant and increasing liquidity needs and may
require additional funding.
> Operating results may vary significantly in future periods.
> We may acquire other companies which could divert our
management’s attention, result in additional dilution to our
shareholders and otherwise disrupt our operations and harm
our operating results.
> A significant portion of our cash and cash equivalents are held
at a small number of banks.
> The market price of our ADSs may be volatile.
> Our largest shareholder owns a significant percentage of our
share capital and voting rights of the Company.
> Substantial future sales of our ADSs in the public market, or
the perception that these sales could occur, could cause the
price of the ADSs to decline.
> Unlike in prior years, as of 1 October 2018, we are required to
comply with the domestic reporting regime under the
Exchange Act and will incur significant legal, accounting and
other expenses, and our management will be required to
devote substantial additional time to new compliance
initiatives and corporate governance matters.
> US investors may have difficulty enforcing civil liabilities
against our Company, our Directors or members of senior
management.
> The rights of our shareholders may differ from the rights
typically offered to shareholders of a US corporation.
> We may be classified as a passive foreign investment company,
or PFIC, in any taxable year and US holders of our ordinary
shares could be subject to adverse US federal income tax
consequences.
Brexit
> The UK’s vote in favour of withdrawing from the European
Union (known as “Brexit”) could lead to increased market
volatility which could adversely impact the market price of our
ADSs and make it more difficult for us to do business in
Europe or have other adverse effects on our business.
In response to this situation, the Group established a cross-
functional Brexit Taskforce early in 2018. The Group’s position
has been to expect the most disruptive impact of Brexit, and
therefore has pre-emptively moved any EU-dependent
pharmaceutical product registrations and employment roles to be
located or duplicated within the European Union.
However, until the Brexit process is concluded by the UK and EU
parliaments and the impacts of transition to any new arrangement
between them are known with clarity, it is difficult to anticipate
the overall potential impact on the Group’s operations and hence
the final expected costs to be incurred.
Risk in Relation to the Use of Financial Instruments
The Group is exposed to a number of financial risks, including
credit risk, liquidity risk, market price risk and exchange rate
risk. It is the Group’s policy that no speculative trading in
financial instruments shall be undertaken, and as such the Group
does not enter into contracts for complicated or compound
financial instruments. Further details are provided in note 21 to
the financial statements.
Credit Risk
> The Group’s principal financial assets are cash and short-term
cash equivalents. Risk is minimised through an investment policy
restricting the investment of surplus cash to interest-bearing
deposits principally held with the major UK banking groups and
with UK subsidiaries of banking groups, and US government
interest-bearing bonds with acceptable credit ratings.
> Trade receivables are concentrated in a small number of large
customers, predominantly across the US and Europe, with
well-established relationships, where the risk and history of
default is considered to be low.
Liquidity Risk
> This risk is minimised by placing surplus funds in a range of
low-risk cash deposits and short-term liquid investments for
periods up to 90 days. This portfolio of deposits is managed to
ensure that a rolling programme of maturity dates is managed
in accordance with Group expenditure plans in order to
ensure available liquid cash funds when required.
Market Price Risk
> Market price risk primarily comprises interest rate exposure
risk, which is managed by maintaining a rolling programme of
varying deposit maturity dates, up to a maximum of 90 days,
on a breakable deposit basis. The majority of funds are
deposited for terms of less than 90 days. This allows the
Group to react to rate changes within a reasonable timeframe
and to mitigate pricing risk accordingly.
11
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Strategic Report continued
Exchange Rate Risk
> The individual financial statements of each Group Company
are prepared in the currency of the primary economic
environment in which it operates (its functional currency).
For the purpose of the consolidated financial statements, the
results and financial position of the Group are presented in
US Dollars.
Exchange rate fluctuations between local currencies and the US
Dollar create risk in several ways, including the following:
The Group maintains and operates a Code of Conduct and
Business Ethics called “i-CARE”. This sets out the Group’s
approach to ensure that our corporate values are maintained
throughout our global business through five main arms:
> Integrity
> Compliance
> Accountability
> Respect
> Ethics
> weakening of the US Dollar may increase the US Dollar cost of
overseas R&D expenses and the cost of sourced product
components outside the US;
> strengthening of the US Dollar may decrease the value of our
revenues denominated in other currencies;
> exchange rates on non-Dollar transactions and cash deposits
can distort our financial results; and
> commercial pricing and profit margins are affected by
currency fluctuations.
This Code applies to all employees of GW companies, who are
required to comply with this policy.
The Group considers that respecting human rights is a global
standard of expected conduct for all business enterprises. The
Group aims to comply with all applicable laws, especially health
and safety, to prevent abuses of human rights. Regular dialogue is
held between employees at each of the Group’s sites and senior
management to ensure that any issues are identified and resolved.
The Group believes that the move to report in US Dollar has
minimised the reporting risk, as the largest proportion of cash
and cash equivalents is held in that currency.
During the period the Group had exposure to Pounds Sterling
(“GBP”), Euros (“€”) and Canadian Dollars (“CAD”). The Group’s
policy is to maintain natural hedges, where possible, by matching
revenue and receipts with expenditure. The Group continues to
hold a large balance of GBP, to match future anticipated GBP-
denominated expenditure on continuing manufacturing, clinical
and capital expenditure activities based in the United Kingdom.
Going Concern
Having reviewed cash flow forecasts for the 12-month period
following the date of signing the financial statements, the
Directors have a reasonable expectation that the Company and
the Group have adequate resources to continue in operational
existence for the foreseeable future. Thus, they continue to adopt
the going concern basis in preparing these financial statements.
Employee Consultation and Human Rights
The Group places considerable value on the involvement of its
employees. They are regularly briefed on the Group’s activities in
Company-wide meetings and updates, and have regular
opportunities to share their views with Executive Officers. Regular
Group-wide employment surveys are conducted, with specific
focused follow-ups to ensure that employee matters are addressed.
We believe that any individual employee’s contribution is a key
element to the future success of the Group and accordingly, the
majority of employees are given the opportunity to participate in
the Company’s share capital by joining one or more of the share
option schemes operated by the Company. Details of the share
options issued under these plans are set out in note 23 to the
financial statements. Equal opportunity is given to all employees
regardless of their age, sex, colour, race, disability, religion or
ethnic origin.
Disabled Employees
Applications for employment by disabled persons are always fully
considered, bearing in mind the aptitudes of the applicant
concerned. In the event of members of staff becoming disabled,
every effort is made to ensure that their employment with the
Group continues and that appropriate training is arranged. It is
the policy of the Group that the training, career development and
promotion of disabled persons should, as far as possible, be
identical with that of other employees.
Our Employees
We aim to recruit, retain and motivate intelligent people who will
share our passion for developing medicines that meet the needs of
patients and who will strive to help us to achieve strategic aims.
We appreciate that the accumulated knowledge and experience of
our staff is one of our greatest assets and we recognise and reward
loyalty.
As at 31 December 2018, 129 (30 September 2017: 119) of our
staff have worked for the Group for more than five years. 50
(2017: 57) of these have been with us for more than 10 years. We
seek to encourage staff retention by offering participation in staff
share option schemes, bonus schemes and the GW Above &
Beyond scheme with which we reward those members of staff
who have demonstrated exceptional achievements, innovative
ideas, great teamwork and/or other praiseworthy achievements
that go beyond the day-to-day requirements of their role.
We recruit individuals who have the skills, experience and
positive attitude needed to optimally perform the roles that we
need in order to help us to drive our business forward. We recruit
without regard to sex or ethnic origin, appointing and thereafter
promoting staff based upon merit, positive attitude and success.
12
GW Pharmaceuticals plc | Annual Report and Accounts 2018 As a business whose core activity starts with the growing of
plants which are actively absorbing carbon dioxide, we have a
natural carbon capture process within our business operations.
We have not sought to quantify the extent to which this offsets
the carbon footprint of our business but we take some comfort
from the fact that this helps to mitigate the environmental impact
of our business and we expect this to increase as the scale of our
growing operations expands to meet future demand for our
plant-derived medicines.
This report was approved by the Board of Directors on 28 March
2019 and signed on its behalf by:
Adam George
Company Secretary
28 March 2019
The profile of the Group’s employees at 31 December 2018 was
as follows:
Male
31 December
2018
Female
31 December
2018
Total
31 December
2018
Number of persons who
were Directors of the Group
(including non-Executive)
Number of persons who were
Executive Officers of the Group
Number of persons who were
Senior Managers of the Group
Number of persons who were
Employees of the Group
Total Employees at
31 December 2018
6
6
23
356
391
2
–
12
396
410
8
6
35
752
801
Environmental Matters
We have reported on all of the emission sources required under
the Companies Act 2006 (Strategic Report and Directors’ Report)
Regulations 2013. Our sources of emission relate principally to
our growing and manufacturing facilities, the costs of which are
included within our consolidated financial statements. We have
responsibility for any emission sources where we bear the
associated costs in our consolidated statements.
We have used the Greenhouse Gas (“GHG”) Protocol Corporate
Accounting and Reporting Standard (revised edition) data
gathered to fulfil our requirements under the CRC Energy
Efficiency scheme, and emission factors from UK Government’s
GHG Conversion Factors for Company Reporting 2016.
We have used the most recent evidence or estimates provided by
our energy supply partners to generate our disclosure of
emissions for the 15-month period ended 31 December 2018.
These include the purchase of electricity, heat, steam or cooling.
The annual quantity of emissions for the Group for 2018 was
2,211 tonnes of carbon dioxide (2017: 2,417 tonnes), produced by
activities for which the Group is responsible. The Group
considers that the intensity ratio of tonnes of carbon dioxide per
employee is a suitable metric for its operations. This was 3.2
tonnes per head average (2017: 4.5 tonnes) for the 15 months
ended 31 December 2018.
The Group is aware of the risks of climate change and actively
looks to minimise indirect areas of emissions by encouraging
remote working and promoting online conferencing facilities to
reduce business-related travel and is actively exploring ways to
reduce the light energy used in some of its plant growing
facilities.
13
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Report
The Directors present their report and the consolidated financial
statements for the Company and for the Group for the 15 months
ended 31 December 2018. The Company has chosen to set out
some of the matters, as outlined below, otherwise required by
regulations made under section 416(4) of the Companies Act
2006 to be disclosed in the Strategic Report as the Directors
consider they are of strategic importance to the Company.
Group Research and Development (“R&D”)
Activities
The R&D undertaken by the Group amounted to $167.1 million
(year ended 30 September 2017: $142.0 million), all of which was
expensed during the 15-month period ended 31 December 2018.
This included $0.6 million (year ended 30 September 2017: $0.7
million) of R&D expenditure which was carried out under
contract for, and was fully funded by, our development partners.
Results and Dividends
The Consolidated Income Statement for the period is set out on
page 40. The Group’s loss after tax for the 15-month period to
31 December 2018 was $341.4 million (year ended 30 September
2017: $168.1 million).
The Directors do not recommend the payment of a dividend (year
ended 30 September 2017: $nil).
Share Capital
Dr Geoffrey W Guy
Justin Gover
James Noble
Thomas Lynch
Cabot Brown
(appointed 21 December 2017)
Catherine Mackey
Alicia Secor
(appointed 21 December 2017)
William Waldegrave (appointed 21 December 2017)
Details of the beneficial interests of Directors in the ordinary
shares of the Company are disclosed within the Directors’
Remuneration Report on page 21.
Details of the Directors’ share options and service contracts are
shown in the Directors’ Remuneration Report.
In accordance with the Articles of Association of the Company,
James Noble and Thomas Lynch will retire by rotation at the
forthcoming Annual General Meeting (“AGM”) and, being
eligible, offer themselves for re-election.
Annual General Meeting
The AGM will be held in London on 13 June 2019. Further
details will be provided to shareholders prior to the meeting.
Details of the resolutions to be proposed at the meeting are set
out in the Notice of AGM 2019 which will be circulated to all
shareholders.
Information relating to changes to the issued share capital during
the period is given in note 22 to the financial statements.
Auditor and Audit Information
The Group is funded principally by ordinary share capital and
has no bank debt as at 31 December 2018 (30 September 2017:
$nil). The Group had a fit-out funding liability of $10.0 million at
31 December 2018 (30 September 2017: $11.1 million) and a
finance lease liability of $6.1 million (30 September 2017: $6.6
million), reflecting funding provided by our landlords to fit out
leased properties of a number of our manufacturing premises.
Substantial Shareholdings
On 28 March 2019 the Company had been notified, in
accordance with the Companies Act 2006, of the following
interests in the ordinary share capital of the Company:
Number of
shares held
Percentage
Capital Research Global Investors (US)
Capital World Investors (US)
Scopia Capital Management L.P.
M&G Investment Management, LTD
CPP Investment Board
43,286,016
32,538,864
16,142,376
15,877,176
14,100,000
11.8
8.9
4.4
4.3
3.8
Each of the persons who is a Director at the date of approval of
this Annual Report confirms that:
(a) so far as the Director is aware, there is no relevant audit
information of which the Company’s auditor is unaware; and
(b) the Director has taken all the steps that he ought to have taken
as a Director in order to make himself aware of any relevant
audit information and to establish that the Company’s auditor
is aware of that information.
This confirmation is given and should be interpreted in
accordance with the provisions of section 418 of the Companies
Act 2006. The Audit Committee has recommended the
reappointment of the Group’s existing auditor, Deloitte LLP,
which will be proposed at the forthcoming AGM.
This report was approved by the Board of Directors on 28 March
2019 and signed on its behalf by
Directors and Their Interests
The following Directors held office during the period and up to
the date of signing the financial statements:
Adam George
Company Secretary
28 March 2019
14
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report
The information provided in this part of the Directors’
Remuneration Report is not subject to audit.
Remuneration Committee Chairman’s
Annual Statement
Dear Shareholder
On behalf of the Board I am pleased to present the Remuneration
Committee’s report for the 15-month period ended 31 December
2018.
I would like to take this opportunity to provide you with an
overview of the Remuneration Committee’s major decisions taken
during 2018, together with the context in which these decisions
were taken.
We were pleased to receive a high level of shareholder voting
support at the Annual General Meeting (“AGM”) in March 2018,
with over 83% of proxy voting in support of the resolution to
adopt the 2017 Remuneration Report, and over 81% of
shareholders supported the approval of the revised Directors’
Remuneration Policy.
Context of the Committee’s Decisions in 2018
2018 has been a year of significant progress with execution of the
Board’s strategy. The launch of Epidiolex® in the United States in
November 2018, following approval from the Food and Drug
Administration (“FDA”) in June 2018 was a pivotal event in the
history of the Company. The Board continue to work on
preparations for Epidiolex approval and launch in Europe, with
an approval decision expected in mid-2019.
Looking forward, we are clear that the primary objective for the
year ahead is to execute a successful US launch. We believe that
we can continue to create shareholder value via successful
execution of our commercial strategy whilst continuing to
advance the development of our pipeline of other cannabinoid
product candidates. It is in this context that the Committee have
made our major decisions during 2018.
The Remuneration Committee
In accordance with best practice, the GW Remuneration Committee,
consisting of independent non-executive Directors under my
Chairmanship, manages the remuneration of the Executive
Directors within the framework of the shareholder-approved
Policy and shareholder-approved LTIP option scheme rules.
Our approach to remuneration:
The Group remuneration policy for Executive Directors aims to:
> align the interests of Executive Directors with those of
shareholders;
> have regard to the individuals’ experience and the nature and
complexity of their work in order to pay a competitive salary
that attracts and retains management of the highest quality,
while avoiding remunerating those Directors more than is
necessary;
> link individual remuneration packages to the Group’s
short-term and long-term performance through the award of
incentives via participation in the Group’s cash and equity-
based incentive schemes;
> provide post-retirement benefits through defined contribution
pension schemes; and
> provide employment-related benefits including the provision of
life assurance and medical assurance.
I believe that these aims, which remain unchanged from previous
years, have been working well, continue to be relevant and
provide a firm framework within which future remuneration will
be determined. The shareholder-approved Policy provides a set of
parameters within which we work whilst still allowing the
Remuneration Committee sufficient flexibility to adapt
remuneration packages in line with the development of the
business. This should allow the Company to attract, retain and
motivate Directors and Executive Officers with the skills, talent
and motivation to deliver upon our strategy and to continue to
create value for our shareholders.
Key Remuneration Committee Activities in 2018:
During 2018 the Remuneration Committee’s key activities have
been as follows:
> At the start of the 2018 financial year, we engaged Willis
Towers Watson as independent advisers to benchmark the
remuneration of the Directors against the selected peer group
and to provide recommendations for basic salaries, Long Term
Incentive Plan (“LTIP”) awards and the structure of bonus
incentive awards for the year. As the Company continues to
grow in size and complexity, the Remuneration Committee
requested that Willis Towers Watson reviewed the peer group
of comparable US-listed biotech/pharmaceutical development
companies. The current peer group consists of ACADIA
Pharmaceuticals Inc., Agios Pharmaceuticals Inc., Alder
Biopharmaceuticals Inc., Alnylam Pharmaceuticals Inc.,
bluebird bio Inc., Clovis Oncology, Inc., Intercept
Pharmaceuticals Inc., Juno Therapeutics Inc., Neurocrine
Biosciences Inc., Pacira Pharmaceuticals Inc., Portola
Pharmaceuticals Inc., Puma Biotechnology Inc., Radius Health
Inc., Sage Therapeutics Inc., Sarepta Therapeutics Inc.,
Spark Therapeutics, Inc., Tesaro Inc. and Ultragenyx
Pharmaceuticals Inc. Willis Towers Watson received $31,805
in compensation for their work relating to Directors’
remuneration advice.
> In February 2018, the Remuneration Committee met to
consider the basic salary increases to be awarded to Executive
Officers. Inflationary increases had been given to the majority
of our staff and the Executive Directors were given an
inflationary basic salary increase of 3% effective from
1 January 2018. External benchmarking analysis for the Chief
Executive Officer and Chief Financial Officer were below the
median of peer group data. The Remuneration Committee
approved an increase in the Chief Executive Officer’s basic
salary to $600,000 and the Chief Financial Officer’s basic
salary to $400,000 effective from 1 March 2018.
> At the same time, the Remuneration Committee met to
consider the extent of achievement of 2017 calendar year
objectives by the Executive Team, and to determine the level of
short-term bonus incentive award to be paid in respect of the
2017 calendar year. The consensus was that 2017 had been a
year of substantial progress with all material objectives having
been achieved, well positioning the Company for FDA
approval. The consensus reached by the Remuneration
Committee was that each member of the Executive Team who
had been present throughout all of 2017 should receive a
15
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
short-term incentive bonus award, in respect of achievements
in the 2017 calendar year equivalent to 60% of their 2017 basic
salary. Those members of the Executive Team who joined
during early 2017, being the Chief Medical Officer, Chief
Financial Officer and Chief Legal Officer, were awarded a
short-term incentive bonus award based upon 50% of their
pro-rata basic salary.
> At the same time, the Remuneration Committee approved the
bonus objectives to be achieved by the Executive Directors
during 2018. The approved objectives are primarily linked to
FDA approval and execution of the Epidiolex US market
launch. These were considered by the Remuneration
Committee to be the key value drivers for the business and
therefore represent the optimum objectives for Executive Team
incentive schemes to be based upon in 2018.
> The Remuneration Committee also met and agreed the terms of
the 2018 grant of LTIP awards to the Directors and Executive
Officers. These were segmented so that:
– 50% of the value of the award is linked to specific
performance conditions, which must be achieved in the
three-year vesting period, with vesting dependent upon US
approval of Epidiolex by the FDA and commercial launch in
the US;
– 25% of the value of the award is in the form of market-
priced share options with a three-year vesting period; and
– 25% of the value of the award took the form of restricted
stock options which vest at the rate of 25% per annum over
a four-year vesting period.
The selected performance conditions are required to be achieved
in order to trigger vesting of 50% of this award are again
considered to be directly linked to key business value drivers
creating alignment with shareholders’ interests. The restricted
stock option element of the award is considered to encourage
long-term retention, considered to be a key factor critical to
future success, and the market priced options are intended to
align the interests of the Executive Directors with shareholders’
interests.
At the grant date in February 2018 these awards had expected
values at grant equivalent to 575% of basic salary for the Chief
Executive Officer, 450% of basic salary for the Executive
Chairman, 400% of basic salary for President, North America
and Chief Financial Officer, 350% of basic salary for Chief Legal
Officer and Chief Operating Officer and 300% for the Chief
Medical Officer, and Managing Director, UK.
> In November 2018, the Remuneration Committee met to
consider the state of achievement of 2018 bonus objectives, to
consider and approve the re-appointment of Willis Towers
Watson as independent remuneration advisers to the
committee for 2019 and to initiate a benchmarking/peer group
refresh exercise. Finally, the Committee considered the
potential impact of the equity incentive award limit contained
within the shareholder approved remuneration policy and the
potential impact upon the committee’s ability to provide
market-competitive remuneration packages to the CEO and
potential new senior executive officer hires in 2019.
16
Proposed change to the Remuneration Policy – for
approval by shareholders at the Annual General Meeting
in June 2019
As a UK registered public company, we are required by the
Companies Act to maintain a shareholder approved remuneration
policy containing a set of limits within which the Remuneration
Committee has discretion to manage Directors’ remuneration.
The policy was last approved by shareholders at the 2018 Annual
General Meeting and has been in use throughout 2018. However,
at the end of 2018 Peer group refresh and benchmarking exercise
conducted on behalf of the committee by our independent
adviser, Willis Towers Watson, together with the recruitment
activity that we have in progress seeking to appoint a new lead US
Commercial Officer, to fill the role that will be vacated by Julian
Gangolli upon his retirement in early 2019, have highlighted the
fact that the current fixed equity incentive award annual limit,
limiting the value of equity incentive awards to a fixed 600% of
annual salary, has the potential to frustrate the Committee’s
ability to maintain a market competitive remuneration package
for the Chief Executive Officer and, potentially, the Committee’s
ability to be able to offer market-competitive remuneration
packages that will enable recruitment and retention of the best
candidates for senior officer roles. With this in mind, the
Committee has consulted with independent advisers and has
concluded that it is necessary to seek shareholder approval for a
single amendment to the remuneration policy at the 2019 AGM,
whereby we propose to replace the existing fixed equity incentive
limit with a limit that is based on peer group benchmarking data,
whereby the value of GW’s annual equity incentive awards to
Directors and senior officers will not exceed the 75th percentile of
peer group data. This is in-line with the approach that is currently
taken with the policy limit for basic salary and should give the
committee the flexibility needed to maintain market-competitive
remuneration incentives structured similarly to those in use by
peer group companies.
With the exception of this single change to the equity incentive
limit outlined above we are confident that the Remuneration
Policy remains appropriate for the business and we intend to seek
approval for the amended policy at the forthcoming AGM in June
2019. On the pages that follow we set out the Remuneration
Policy that, if approved, will be effective until 2022 unless any
changes are required before then. We believe that the Policy set
out on the following pages continue to give the Remuneration
Committee transparent powers to implement appropriate
incentive rewards, in line with US market practice, enabling us to
continue to maintain appropriate remuneration for the existing
Executive and non-executive Directors as they work to continue
the success of the Company.
Thomas Lynch
Remuneration Committee Chairman
28 March 2019
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Annual Report on Remuneration
The information provided in this part of the Directors’ Remuneration Report is subject to audit.
Single Total Figure of Remuneration for Each Director
The Directors received the following remuneration for the 15 months ended 31 December 2018:
Name of Director
Executive
Dr Geoffrey W Guy
Justin Gover
Non-executive
James Noble
Cabot Brown
Thomas Lynch1
Catherine Mackey
Alicia Secor
William Waldegrave3
Salary and
fees
£
Taxable
benefits
£
Short-term
incentives
£
Long-term
incentive
plans2
£
Pension
contributions
£
2018 total
£
521,535
486,511
4,602
19,029
1,852,124
271,010
236,018 2,041,377
– 2,649,271
7,784 2,790,719
86,460
84,587
–
53,956
52,029
48,840
–
–
–
–
–
–
–
–
–
–
–
–
257,471
257,471
257,471
–
–
–
–
–
–
–
–
–
343,931
342,058
257,471
53,956
52,029
48,840
Aggregate emoluments
1,333,918
23,631
507,028
4,665,914
7,784 6,538,275
1
Since his appointment as a non-executive Director in July 2010, Thomas Lynch has waived his right to receive fees, taxable benefits, short-term incentives and pension
contributions for this role.
2 LTIP gains represent the unrealised gains on LTIPs that vested during the 15 months ended 31 December 2018, calculated according to the share price at the date of vesting.
These gains have not been realised by 31 December 2018 as the Directors have not exercised or sold these LTIPs.
3 Not included within William Waldegrave’s salary and fees received is £13,800 relating to amounts paid for services provided prior to appointment as a Director of the Company.
The Directors received the following remuneration for the year ended 30 September 2017:
Name of Director
Executive
Dr Geoffrey W Guy
Justin Gover
Adam George3
Dr Stephen Wright3
Chris Tovey3
Julian Gangolli3
Non-executive
James Noble
Cabot Brown
Thomas Lynch1
Salary and
fees
£
Taxable
benefits
£
Short-term
incentives
£
Long-term
incentive
plans2
£
Pension
contributions
£
11,878
38,393
5,951
6,874
6,008
1,350
355,603
362,329
198,248
243,564
215,234
324,830
837,415
787,350
411,546
506,492
446,804
316,955
18,228
15,492
10,162
12,485
11,033
11,395
2017 total
£
1,644,151
1,610,329
705,864
864,369
763,064
790,095
–
–
–
–
–
–
–
–
–
–
–
–
69,600
68,181
–
421,027
406,765
79,957
94,954
83,985
135,565
69,600
68,181
–
Aggregate emoluments
1,360,034
70,454 1,699,808 3,306,562
78,795
6,515,653
1
Since his appointment as a non-executive Director in July 2010, Thomas Lynch has waived his right to receive fees, taxable benefits, short-term incentives and pension
contributions for this role.
2 LTIP gains represent the unrealised gains on LTIPs that vested during the year ended 30 September 2017, calculated according to the share price at the date of vesting. These gains
have not been realised by 30 September 2017 as the Directors have not exercised or sold these LTIPs.
3 The indicated Directors resigned their Statutory Directorships on 13 February 2017. All remained in employment with the Company until 30 September 2017, but no longer
constitute voting Board members. In respect of their post-Directorship periods, not included in the table above, Adam George received a total of £172,425, Dr Stephen Wright
received £131,066, Chris Tovey received £172,523 and Julian Gangolli received £196,311.
17
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Long-Term Incentive Awards Vesting During the Financial Year
On 6 January 2018, the vesting period for first tranche of Restricted Stock Options awarded to Justin Gover during 2017 ended. The
vesting of this award was linked to continuing employment with the Company throughout the vesting period. The intrinsic value of
these vested options has been included in the 2018 remuneration table above based on the share price at the vesting date of £8.09 per
ordinary share.
On 15 February 2018, the vesting period for second tranche of Restricted Stock Options awarded to the Executive Directors during
2016 ended. The vesting of this second award was linked to continuing employment with the Company throughout the two-year
vesting period. The intrinsic value of these vested options has been included in the 2018 remuneration table above based on the share
price at the vesting date of £7.77 per ordinary share.
On 24 June 2018, vesting periods for three tranches of options, awarded to the Executive Directors, completed:
i) Market-priced Options: The vesting of this award was linked to continuing employment with the Company throughout the
three-year vesting period.
ii) Restricted Stock Options: The vesting period for the third and final tranche awarded during 2015 ended. The vesting of this third
award was linked to continuing employment with the Company throughout the three-year vesting period.
iii) Performance Stock Options: The vesting of this award was linked to two performance conditions:
– Vesting of half of the performance stock options will occur upon receipt from FDA of their confirmation of acceptance of an
Epidiolex NDA filing.
– Vesting of half of the performance stock options will occur upon FDA grant of Epidiolex regulatory approval.
Both conditions were met, and therefore all options vested.
In all instances, the intrinsic value of these vested options has been included in the 2018 remuneration table above based on the share
price at the vesting date of £9.11 per ordinary share.
On 10 August 2018, the vesting period for first tranche of Restricted Stock Options awarded to Geoffrey Guy during 2017 ended. The
vesting of this award was linked to continuing employment with the Company throughout the vesting period. The intrinsic value of
these vested options has been included in the 2018 remuneration table above based on the share price at the vesting date of £8.79 per
ordinary share.
On 29 December 2018, vesting periods for two tranches of options, awarded to the Non-Executive Directors, completed:
i) Restricted Stock Options: The vesting period for the tranche awarded during 2015 ended. The vesting of this award was linked to
continuing service to the Company throughout the three-year vesting period.
ii) Market-Priced Options: The vesting of this award was linked to continuing service with the Company throughout the three-year
vesting period.
In both instances above, the intrinsic value of these vested options has been included in the 2018 remuneration table above based on
the share price at the vesting date of £6.39 per ordinary share.
Long-Term Incentive Awards Granted to the Directors and Executive Officers in 2018
Directors and Executive Officers are awarded LTIPs at the discretion of the Remuneration Committee. Awards are typically calculated
with reference to the closing mid-market ordinary share price of the Company’s ordinary shares on the day prior to grant. During
periods of volatility, the price used to determine award size is determined by reference to the average closing mid-market ordinary
share price of the previous five trading days.
Following the completion of the review of the Group’s remuneration strategy, the Directors and Executive Officers were awarded
options to subscribe for the Company’s ordinary shares split into three different types of options:
> market-priced options, whereby the options have an exercise price equivalent to the market price at market close on the day prior to
grant;
> performance stock options, whereby the options will vest upon the third anniversary of the date of grant subject to certain
corporate performance conditions having been achieved; and
> restricted stock options, whereby the options are subject to a four-year service condition and vesting period. 25% of the options
will vest on each anniversary of the date of grant over the four-year period.
18
GW Pharmaceuticals plc | Annual Report and Accounts 2018 In general, the awards may be exercised at any time between the vesting date and the 10th anniversary of the date of grant. Our
US-based Directors and Executive Officers will be required to exercise their performance stock and restricted stock options before
15 March of the year following the year of vesting. The exercise price of the performance stock options and restricted stock options is
0.1p per ordinary share, being the par value of the shares. Awards which do not vest at the end of the vesting period will lapse
permanently. The Company’s share options are traded on NASDAQ as American Depositary Shares (“ADSs”), for which 12 ordinary
shares equate to one ADS.
The table below sets out the LTIPs awarded in the 15-month period to 31 December 2018 to Executive Directors:
Granted
Value at date
of grant (£)
Valuation
method
Exercise
price
Performance
period end
Date of expiry
% of award
vesting for
minimum
performance
Name of Director
Justin Gover
Market-priced options
Performance stock options
Restricted stock units year 1 – 25%
Restricted stock units year 2 – 25%
Restricted stock units year 3 – 25%
Restricted stock units year 4 – 25%
Dr Geoffrey W Guy
Market-priced options
147,624
636,232
Fair value
299,196
22,440
22,440
22,440
22,440
2,103,326
157,752
157,752
157,752
157,752
Fair value
Fair value
Fair value
Fair value
Fair value
107,352
462,667
Fair value
Performance restricted stock units
Restricted stock options year 1 – 25%
Restricted stock options year 2 – 25%
Restricted stock options year 3 – 25%
Restricted stock options year 4 – 25%
217,572
16,317
16,317
16,317
16,317
1,529,515
114,707
114,707
114,707
114,707
Fair value
Fair value
Fair value
Fair value
Fair value
The vesting of the above awards is subject to the following performance conditions.
685.1p
($115.31
per ADS)
0.1p
0.1p
0.1p
0.1p
0.1p
685.1p
($115.31
per ADS)
0.1p
0.1p
0.1p
0.1p
0.1p
26/02/2021
26/02/2028
100%
26/02/2021
26/02/2019
26/02/2020
26/02/2021
26/02/2022
26/02/2021
26/02/2019
26/02/2020
26/02/2021
26/02/2022
0%
100%
100%
100%
100%
26/02/2021
26/02/2028
100%
26/02/2021
26/02/2019
26/02/2020
26/02/2021
26/02/2022
26/02/2028
26/02/2028
26/02/2028
26/02/2028
26/02/2028
0%
100%
100%
100%
100%
Grant Relating to Executive Directors
25% of the awards are in the form of market-priced options, whereby the options have an exercise price equivalent to the market price
at market close on the day prior to grant ($115.31 per ADS, equivalent to 685.1p per ordinary share). These options become exercisable
on the third anniversary of the date of grant. Future gains upon exercise of these options will be linked to the extent of share price
growth over the vesting period. The Committee consider that this element of the awards will help to ensure continuing alignment
between Executive and shareholders’ interests. The Black-Scholes option pricing model was used to derive the fair values.
50% of the awards are in the form of performance stock options, whereby the options will vest upon the third anniversary of the date
of grant subject to certain corporate performance conditions having been achieved.
(i) half of the share options vested upon US approval of Epidiolex by the FDA; and
(ii) half vest upon commercial launch in the US.
The Remuneration Committee considers these particular milestones to be important elements of our agreed strategy and the key value
drivers for the business at this time.
25% of the awards are in the form of restricted stock options for UK-based Directors, or restricted stock units for US-based Directors,
whereby these options are subject to a four-year service condition and vesting period. 25% of the options will vest on each anniversary
of the date of grant over the next four years. US-based Directors’ restricted stock units are automatically exercised immediately on
successful vesting. The committee consider that this element of the awards should help to ensure retention of our team of Executive
Directors, a key factor for GW’s future success.
19
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Long-Term Incentive Awards Granted to the Non-Executive Directors in the 15-month period to 31 December 2018
During January 2018, the executive members of the Board met to discuss and approve the latest such award.
The table below sets out the LTIPs awarded in the 15-month period to 31 December 2018 to non-executive Directors:
Granted
Value at date
of grant
Valuation
method
Exercise price
Performance
period end
Date of expiry
% of award
vesting for
minimum
performance
Name of Director
James Noble
Market-priced options
17,676
88,571
Fair value
Restricted stock options – year 1 (1/3rd)
Restricted stock options – year 2 (1/3rd)
Restricted stock options – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
Cabot Brown
Market-priced options
17,676
88,571
Fair value
Restricted stock units – year 1 (1/3rd)
Restricted stock units – year 2 (1/3rd)
Restricted stock units – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
Thomas Lynch
Market-priced options
17,676
88,571
Fair value
Restricted stock options – year 1 (1/3rd)
Restricted stock options – year 2 (1/3rd)
Restricted stock options – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
Catherine Mackey
Market-priced options
35,340
177,083
Fair value
Restricted stock units – year 1 (1/3rd)
Restricted stock units – year 2 (1/3rd)
Restricted stock units – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
Alicia Secor
Market-priced options
35,340
177,083
Fair value
Restricted stock units – year 1 (1/3rd)
Restricted stock units – year 2 (1/3rd)
Restricted stock units – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
William Waldegrave
Market-priced options
35,340
177,083
Fair value
Restricted stock options – year 1 (1/3rd)
Restricted stock options – year 2 (1/3rd)
Restricted stock options – year 3 (1/3rd)
3,580
3,580
3,580
29,487
29,487
29,487
Fair value
Fair value
Fair value
20
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
821.4p
($134.09
per ADS)
0.1p
0.1p
0.1p
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2028
03/01/2028
03/01/2028
100%
100%
100%
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2019
03/01/2020
03/01/2010
100%
100%
100%
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2028
03/01/2028
03/01/2028
100%
100%
100%
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2019
03/01/2020
03/01/2010
100%
100%
100%
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2019
03/01/2020
03/01/2010
100%
100%
100%
03/01/2021
03/01/2028
100%
03/01/2019
03/01/2020
03/01/2010
03/01/2028
03/01/2028
03/01/2028
100%
100%
100%
GW Pharmaceuticals plc | Annual Report and Accounts 2018 50% of the awards are in the form of market-priced options, whereby the options have an exercise price equivalent to the market price
at market close on the day prior to grant ($134.09 per ADS, equivalent to 821.8p per ordinary share). These options become
exercisable on the third anniversary of the date of grant. Future gains upon exercise of these options will be linked to the extent of
share price growth over the vesting period. The Committee consider that this element of the awards will help to ensure continuing
alignment between Executive and shareholders’ interests. The Black-Scholes option pricing model was used to derive the fair values.
50% of the awards are in the form of restricted stock options for UK-based Non-Executive Directors, or restricted stock units for
US-based Non-Executive Directors, whereby these options are subject to a three-year service condition and vesting period. 33% of the
options will vest on each anniversary of the date of grant over the next three years. US-based Directors’ restricted stock units are
automatically exercised immediately on successful vesting. The committee consider that this element of the awards should help to
ensure retention of our team of non-executive Directors, a key factor for GW’s future success.
Awards for Catherine Mackey, Alicia Secor and William Waldegrave included an additional joining tranche of market-priced options
to reflect the commencement of their appointment to the Board.
In structuring these grants, the Directors were mindful of best practice advice received from Willis Towers Watson whereby the award
of options with vesting linked to performance is considered to have the potential to impair the independence of the non-executive
members of the Board. It is for this reason that the vesting of awards is not linked to specific future performance conditions.
Statement of Directors’ Shareholding and Share Interests
The table below shows, for each Director, the total number of ordinary shares owned, the total number of share options with and
without performance conditions, those vested but unexercised and those exercised during the period.
Name of Director
Executive
Dr Geoffrey W Guy
Justin Gover
Non-executive
James Noble
Cabot Brown
Thomas Lynch
Catherine Mackey
Alicia Secor
William Waldegrave
Nominal-cost options:
Unvested
with
performance
measures
Unvested
without
performance
measures2
Shares
owned1
Vested
not yet
exercised
Exercised
during the
Period
9,470,446
2,558,999
767,641
937,219
601,039
716,871
15,343
123,725
362,771
262,009
27,500
7,200
–
–
–
–
–
–
–
–
–
–
56,220
56,220
56,220
46,080
46,080
46,080
82,601
82,601
82,601
–
–
–
–
–
–
–
–
–
1 This comprises the Directors’ holding of ordinary shares as at 31 December 2018. Further details are given in the table on the following page.
2 Unvested awards in this column are solely subject to a service performance requirement.
Note: Each NASDAQ listed ADS represents 12 0.1 pence ordinary shares.
21
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
The table below shows the total number of Directors’ interests in the ordinary shares of GW Pharmaceuticals plc:
Name of Director
Executive
Dr Geoffrey W Guy1
Justin Gover2
Non-executive
James Noble
Cabot Brown
Thomas Lynch
Catherine Mackey
Alicia Secor
William Waldegrave
Ordinary shares of
0.1p
31 December
2018
Ordinary
shares of 0.1p
30 September
2017
9,470,446
2,558,999
10,647,856
2,513,759
27,500
7,200
–
–
–
–
27,500
7,200
–
–
–
–
1 Dr Geoffrey Guy’s holding includes 403,925 ordinary shares held by his personal pension plan and 25,000 held by his wife.
2
Note: Each NASDAQ listed ADS represents 12 ordinary 0.1 pence shares.
Justin Gover’s holding includes 2,143,308 ordinary shares held by The Gover Family Investment LLP, of which Justin owns 99% and the remaining 1% is held by his wife.
The interests of the Directors in share options over the ordinary shares of the Company as at 31 December 2018 were:
Name of Director
Geoffrey Guy
At 1 Oct
2017
11
9
82,639
69,202
9,740
9,740
9,740
129,869
9,740
182,171
25,914
25,914
25,914
345,517
25,914
138,672
15,336
15,336
15,336
15,336
204,552
–
–
–
–
–
–
Granted
Exercised
Lapsed
At 31 Dec
2018
Nominal
value
Exercise
price
Date of
vesting
Date of
expiry
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
107,352
16,317
16,317
16,317
16,317
217,572
(11)
(9)
(82,639)
(69,202)
(9,740)
(9,740)
(9,740)
(129,869)
–
–
(25,914)
(25,907)
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
9,740
182,171
–
7
25,914
345,517
25,914
138,672
15,336
15,336
15,336
15,336
204,552
107,372
16,317
16,317
16,317
16,317
217,572
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
671.0p
0.1p
0.1p
0.1p
0.1p
0.1p
257.0p
0.1p
0.1p
0.1p
0.1p
0.1p
645.6p
0.1p
0.1p
0.1p
0.1p
0.1p
685.1p
0.1p
0.1p
0.1p
0.1p
0.1p
06/06/2015
24/09/2016
12/08/2017
24/06/2018
24/06/2016
24/06/2017
24/06/2018
24/06/2018
24/06/2019
15/02/2019
15/02/2017
15/02/2018
15/02/2019
15/02/2019
15/02/2020
10/08/2020
10/08/2018
10/08/2019
10/08/2020
10/08/2021
10/08/2020
26/02/2021
26/02/2019
26/02/2020
26/02/2021
26/02/2022
26/02/2021
06/06/2022
24/09/2023
12/08/2024
24/06/2025
24/06/2025
24/06/2025
24/06/2025
24/06/2025
24/06/2025
15/02/2026
15/02/2026
15/02/2026
15/02/2026
15/02/2026
15/02/2026
10/08/2027
10/08/2027
10/08/2027
10/08/2027
10/08/2027
10/08/2027
26/02/2028
26/02/2028
26/02/2028
26/02/2028
26/02/2028
26/02/2028
Total
1,356,602
390,192
(362,771)
– 1,384,023
22
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Granted
Exercised
Lapsed
At 31 Dec
2018
Nominal
value
Exercise
price
Date of
vesting
Date of
expiry
Name of Director
Justin Gover
Total
James Noble
Total
Cabot Brown
Total
Thomas Lynch
At 1 Oct
2017
67,955
75,874
10,679
10,679
142,391
10,679
213,245
30,334
30,334
30,334
404,455
30,334
142,344
17,517
17,517
17,517
17,517
233,568
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
147,624
22,440
22,440
22,440
22,440
299,196
(67,955)
–
(10,668)
(10,679)
(142,382)
–
–
(30,325)
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
(11)
–
(9)
–
–
(9)
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
75,874
–
–
–
10,679
213,245
–
30,334
30,334
404,455
30,334
142,344
17,517
17,517
17,517
17,517
233,568
147,624
22,440
22,440
22,440
22,440
299,196
1,503,273
536,580
(262,009)
(29) 1,777,815
68,122
14,479
18,636
9,168
–
–
–
–
–
–
–
–
17,676
3,580
3,580
3,580
110,405
28,416
68,122
14,479
18,636
9,168
–
–
–
–
–
–
–
–
17,676
3,580
3,580
3,580
110,405
28,416
68,122
14,479
18,636
9,168
–
–
–
–
–
–
–
–
17,676
3,580
3,580
3,580
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
68,122
14,479
18,636
9,168
17,676
3,580
3,580
3,580
138,821
68,122
14,479
18,636
9,168
17,676
3,580
3,580
3,580
138,821
68,122
14,479
18,636
9,168
17,676
3,580
3,580
3,580
138,821
Total
110,405
28,416
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
671.0p
0.1p
0.1p
0.1p
0.1p
257.0p
0.1p
0.1p
0.1p
0.1p
0.1p
792.4p
0.1p
0.1p
0.1p
0.1p
0.1p
685.1p
0.1p
0.1p
0.1p
0.1p
0.1p
383.0p
0.1p
792.4p
0.1p
821.8p
0.1p
0.1p
0.1p
383.0p
0.1p
792.4p
0.1p
821.8p
0.1p
0.1p
0.1p
383.0p
0.1p
792.4p
0.1p
821.8p
0.1p
0.1p
0.1p
12/08/2017
24/06/2018
24/06/2017
24/06/2018
24/06/2018
24/06/2019
15/02/2019
15/02/2017
15/02/2018
15/02/2019
15/02/2019
15/02/2020
06/01/2020
06/01/2018
06/01/2019
06/01/2020
06/01/2021
06/01/2020
26/02/2021
26/02/2019
26/02/2020
26/02/2021
26/02/2022
26/02/2021
29/12/2018
29/12/2018
06/01/2020
06/01/2020
03/01/2021
03/01/2019
03/01/2020
03/01/2021
29/12/2018
29/12/2018
06/01/2020
06/01/2020
03/01/2021
03/01/2019
03/01/2020
03/01/2021
29/12/2018
29/12/2018
06/01/2020
06/01/2020
03/01/2021
03/01/2019
03/01/2020
03/01/2021
12/08/2024
24/06/2025
24/12/2017
24/12/2018
24/12/2018
24/12/2019
15/02/2026
15/08/2017
15/08/2018
15/08/2019
15/08/2019
15/08/2020
06/01/2027
15/03/2019
15/03/2020
15/03/2021
15/03/2022
15/03/2021
26/02/2028
26/02/2019
26/02/2020
26/02/2021
26/02/2022
26/02/2021
29/12/2025
29/12/2025
06/01/2027
06/01/2027
03/01/2028
03/01/2028
03/01/2028
03/01/2028
29/06/2019
29/06/2019
06/01/2027
15/03/2021
03/01/2028
03/01/2019
03/01/2020
03/01/2021
29/12/2025
29/12/2025
06/01/2027
06/01/2027
03/01/2028
03/01/2028
03/01/2028
03/01/2028
23
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Name of Director
Catherine Mackey
Total
Alicia Secor
Total
William Waldegrave
Total
At 1 Oct
2017
Granted
Exercised
Lapsed
At 31 Dec
2018
Nominal
value
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
35,340
3,580
3,580
3,580
46,080
35,340
3,580
3,580
3,580
46,080
35,340
3,580
3,580
3,580
46,080
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
–
35,340
3,580
3,580
3,580
46,080
35,340
3,580
3,580
3,580
46,080
35,340
3,580
3,580
3,580
46,080
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
0.1p
Exercise
price
821.8p
0.1p
0.1p
0.1p
821.8p
0.1p
0.1p
0.1p
821.8p
0.1p
0.1p
0.1p
Date of
vesting
Date of
expiry
03/01/2021
03/01/2019
03/01/2020
03/01/2021
03/01/2021
03/01/2019
03/01/2020
03/01/2021
03/01/2021
03/01/2019
03/01/2020
03/01/2021
03/01/2028
03/01/2019
03/01/2020
03/01/2021
03/01/2028
03/01/2019
03/01/2020
03/01/2021
03/01/2028
03/01/2028
03/01/2028
03/01/2028
During the 15-month period 624,780 options (year to 30 September 2017: 1,697,437) over ordinary shares were exercised. The average
exercise price for the 15-month period ended 31 December 2018 was £0.744 (year to 30 September 2017: £0.001) and the average
market price per US-listed ADR, each equivalent to 12 ordinary shares and denominated in US Dollars, at date of exercise was $126.97
(year to 30 September 2017: $114.11).
The market price of the Company’s US-listed ADRs as at 31 December 2018 was $97.39 (30 September 2017: $101.49) and the range
during the 15-month period to 31 December was $94.36 to $174.50 (year to 30 September 2017: $94.14 to $134.02).
Illustration of Total Shareholder Return
The information provided in this part of the Directors’ Remuneration Report is not subject to audit.
The graph below shows the Company’s performance, measured by total shareholder return, for the ADSs listed on NASDAQ as
compared to the NASDAQ Biotech Index (“NASDAQ BTI”). GW’s ADSs are a constituent of the NASDAQ BTI, so this is considered
to be the most suitable comparator index.
Total ADR Shareholder Return (£000s)
)
£
(
e
u
a
V
l
1,750
1,500
1,250
1,000
750
500
250
0
31 Mar 14
30 Sep 14
31 Mar 15
30 Sep 15
31 Mar 16
30 Sep 16
31 Mar 17
30 Sep 17
31 Mar 18
30 Sep 18
GW Pharmaceuticals plc ADR
Nasdaq Biotech Index
This graph shows the daily movements to 31 December 2018 of $100 invested in GW Pharmaceuticals plc ADRs on 1 May 2013
compared with the value of $100 invested in the Nasdaq Biotech Index.
24
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Chief Executive Officer Total Remuneration History
The table below sets out total remuneration details for the Chief Executive Officer in British Pounds Sterling.
Year
2018
2017
2016
2015
2014
2013
2012
2011
2010
2009
CEO Single
Figure of Total
Remuneration1
2,790,719
1,610,329
3,129,535
1,295,928
1,390,235
482,084
586,171
541,294
535,325
354,871
Short-Term
Incentive
Pay-out Against
Maximum
Long-Term
Incentive Vesting
Rates Against
Maximum
Opportunity
100%
100%
48%
50%
100%
35%
50%
30%
70%
23%
100%
100%
100%
50%
100%
50%
100%
100%
100%
100%
1 This total includes unrealised gains on share options vesting in each of the financial years shown above.
The table below shows the percentage change in remuneration of the Chief Executive Officer and the Company’s employees as a whole
between 2017 and 2018.
Basic salary
Taxable benefits
Short-term incentives
Percentage increase in
remuneration in 2018
compared with
remuneration in 2017
CEO
%
All employees
%
9
(48)
(29)
3
33
7
The employee comparator group comprises employees in the UK and the US. We consider this to be an appropriate comparator group
because it is representative of the Group and the employee populations are well balanced in terms of seniority and demographics. To
provide a meaningful comparison of salary increases, a consistent employee comparator group is used by which the same individuals
appear in the 2017 and 2018 group.
Relative Importance of Spend on Pay
The Committee has determined that total expenditure is the most relevant comparator for staff costs of the Group. Dividend
distribution and share buy-back comparators have not been included as the Group has no history of such transactions.
The graph below shows the Group actual staff costs as compared to total expenditure for the last two financial years and illustrates the
year-on-year growth in both. Staff costs continue to grow faster than total spend as, in addition to headcount growth we have been
expanding our manufacturing and commercialisation team headcount in preparation for future commercialisation of Epidiolex.
Relative Importance of Spend on Pay (£000s)
400,000
350,000
300,000
250,000
200,000
150,000
100,000
50,000
0
+82%
12 months to
September 2017
15 months to
December 2018
+108%
Total expenditure
Staff costs
25
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Proposed Application of the Remuneration Policy for the Year Ended 31 December 2019
Executive Directors’ remuneration packages are considered annually and comprise a number of elements, as follows:
i) Fixed Elements of Remuneration
Fixed elements of remuneration including basic salary, pension contributions and other benefits will be set and paid in accordance
with our Remuneration Policy. Any changes to salary will be considered in the context of a number of factors including the annual
peer group based benchmarking exercise carried out for the Remuneration Committee by Willis Towers Watson, home-market
location, any changes to executive responsibilities since the last review and broader employee increases.
ii) Short-Term Incentive
The Remuneration Committee met in February 2019 to assess Director and Executive Officer performance for the calendar year ended
31 December 2018. Based upon this assessment and in accordance with the Remuneration Policy Report below, the Remuneration
Committee awarded a cash bonus payment to each Executive Director. Further details will be provided in the 2019 Annual Report.
iii) Long-Term Incentive Plan
The February 2016 LTIP award was scheduled to vest on 15 February 2019. This award was divided at grant into a number of tranches:
> 25% of the awards are in the form of market-priced options, whereby the options have an exercise price equivalent to the market
price at market close on the day prior to grant ($44.64 per ADS). These options become exercisable on the third anniversary of the
date of grant.
> 50% of the awards are in the form of performance stock options, whereby the options will vest upon the third anniversary of the
date of grant subject to certain corporate performance conditions having been achieved.
– Vesting of half of the performance stock options will occur upon receipt from FDA of their confirmation of acceptance of an
Epidiolex NDA filing.
– Vesting of half of the performance stock options will occur upon FDA grant of Epidiolex regulatory approval.
> 25% of the awards are in the form of restricted stock options whereby these options are subject to a four-year service condition and
vesting period. 25% of the options will vest on each anniversary of the date of grant over the next four years.
100% of the LTIP award vested on 15 February 2019.
iv) Non-Executive Director Fees and Equity-Based Incentives
We do not expect the level of cash-based fees to change during 2019 but we do expect there to be a further grant of equity-based
incentives. This grant will be subject to approval by the executive members of the Board and is likely to be linked to a combination of
share price performance and service-based conditions.
26
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Remuneration Committee Approach to Remuneration Matters
The Remuneration Committee comprises Cabot Brown and Catherine Mackey under the chairmanship of Thomas Lynch.
During the year the Committee received advice from Adam George in his capacity as Company Secretary. The Committee also retains
Willis Towers Watson to provide ongoing peer group remuneration benchmarking, option valuations and remuneration policy related
advice. The Committee is satisfied that Willis Towers Watson, signatories of the Remuneration Consultants’ Code of Conduct,
provides independent and objective advice.
The terms of reference of the Remuneration Committee can be found on the GW website at www.gwpharm.com.
Statement of Voting at Annual General Meeting
The Group is committed to ongoing shareholder dialogue and the Remuneration Committee takes an active interest in voting outcomes.
Voting at our shareholder meetings is generally conducted by a show of hands by shareholders who are in attendance at the meeting.
Such votes have resulted in unanimous approval of the Directors’ Remuneration Report at each of the last three AGMs. No votes were
withheld.
On 14 March 2018 the Group put the Remuneration Policy to shareholders for approval and at the AGM held on that date, 83.36% of
shareholders’ proxy votes approved the September 2017 Directors’ Remuneration Report.
In the event that we experience significant levels of shareholder votes against any remuneration-related resolutions we will seek to
investigate the reasons for such votes and in the event that the Remuneration Committee consider that changes to the Remuneration
Policy are appropriate, we will disclose details of proposed changes in a timely manner.
Remuneration Policy Report
The information provided in this part of the Directors’ Remuneration Report is not subject to audit.
The Remuneration Policy has been designed to ensure that Executive Directors are appropriately incentivised and rewarded for their
performance, responsibility and experience. The Remuneration Committee aims to ensure that the policy aligns the interests of
Directors with those of shareholders.
The Remuneration Policy that follows will be presented to shareholders at the AGM in June 2019 for a binding vote. Following
shareholder approval this policy then became effective from the date of the AGM and will remain in use for three years, or until a
revised policy is approved by shareholders. There will continue to be an advisory vote on the Directors’ Remuneration Report
presented to shareholders at the AGM on an annual basis.
For the avoidance of doubt, in approving this Directors’ Remuneration Policy, authority is given to the Company to honour any
commitments entered into with current or former Directors (such as the payment of a pension or the vesting/exercise of past share
awards). Details of any payments to former Directors will be set out in the Annual Report on Remuneration as they arise.
Future Policy Table
The policy table on the following page describes GW’s shareholder-approved Remuneration Policy for Directors and seeks to explain
how each element of the Directors’ remuneration packages operates.
27
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Summary Remuneration Policy – Directors
Element of
remuneration
Purpose and link to
strategy
Operation
Salary
Rewards skills
and experience
and provides
the basis for
a competitive
remuneration
package.
Retirement
savings
Enables
Executive
Directors to
build long-term
retirement
savings.
Benefits
Protects against
risks and
provides other
benefits in line
with market
practice.
28
Salaries will be reviewed annually
by reference to market practice
and market data, on which the
Committee receives independent
advice, rates of inflation, broader
employee increases, the individual’s
experience and scope of the role.
Salaries will be benchmarked
against comparable roles in a
selected peer group of other
US-listed pharmaceutical
development companies with
similar market capitalisations
and/or scale of operational
complexity. We typically
expect to align salaries with
the 50th percentile of peer
group comparator data but
may vary from this general rule
where we consider that special
circumstances apply or where
recruitment or retention of a
particular role is required.
The Committee may also decide
to approve future increases
following changes to job
responsibilities or to reflect
experience within the role.
Company contribution to a
personal pension/401(k) scheme
or salary supplement. Levels will
be reviewed annually and the
Committee may decide to increase
future contribution levels should
the review indicate such a change
is appropriate. Statutory limits to
employer contributions will be
applied.
Benefits currently include
death-in-service life insurance,
family private medical cover,
ill-health income protection and
a taxed cash car allowance. The
Committee will review benefits
offered from time to time and
retains the discretion to add or
substitute benefits to ensure they
remain market competitive.
In the event that the Group
requires a Director or Executive
Officer to relocate, we would
offer appropriate relocation
assistance and would be likely to
update the package of benefits to
align with local market practice,
e.g. increased health insurance
benefits if relocating to US.
Changes to be
proposed
None
Maximum
Performance targets
Not applicable.
Salaries will not
exceed the 75th
percentile of peer
group comparator
data for the
relevant role.
The Committee
will reference
alternative
comparator data
for roles not
widely represented
in the core peer
group.
None
Up to 5% of basic
salary.
Not applicable
performance conditions.
Not applicable.
None
The disclosed
taxable value
of benefits and
allowances is
not expected to
exceed 15% of
salary per annum.
The Committee
may exceed this
in the event of
relocation, both
on a one-off and
ongoing basis to
align with local
market norms.
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Maximum
Performance targets
Up to 150%
of salary.
Changes to be
proposed
None
Element of
remuneration
Purpose and link to
strategy
Operation
Short-term
incentive
awards
Incentivises
and rewards
achievement
of the near-
term business
objectives,
reflecting
individual
and team
performance of
the Directors
and Executive
Officers.
Objectives are set at the start of
each calendar year.
The choice of annual performance
objectives will reflect the
Committee’s assessment of the
key milestones/metrics required
to be achieved within the calendar
year in order to make progress
towards achieving GW’s strategic
plan.
Payable in cash.
Clawback provisions will apply
(see details below).
Long-term
incentive
awards
Rewards
execution of
GW’s strategic
plan and
growth in
shareholder
value over
a multi-
year period.
Encourages
achievement of
strategy over
the medium to
long term and
aligns Executive
Directors’
interests
with those of
shareholders.
Conditional awards of nominal-
cost options, share options,
performance shares and/or
restricted shares.
Awards normally vest over
periods of three or more years.
The Committee is
able to grant awards which permit
phased vesting over the period.
Clawback provisions will apply
(see details below).
Individual
awards in any
one year will
not exceed
the 75th
percentile of
peer group
data
Individual awards
in any one year
will not exceed
the 75th percentile
of peer group
data.
Expected values
are calculated in
accordance with
generally accepted
methodologies
based on
Black-Scholes
or binomial
stochastic models.
The Committee retains the
ability to set performance
objectives annually.
These objectives can
be Group-based and/or
individual, financial and/
or non-financial, and are
likely to include various
milestones linked to:
> successful execution of
key elements of the
Epidiolex development
programme and
worldwide
commercialisation;
> identification and
execution of other new
orphan drug
developments;
> key regulatory steps
(IND grants, NDA
filings, regulatory
approvals);
> successful
commercialisation of
approved products,
either by our own
commercial
organisation or by our
partners;
> the Group’s financial
position and results;
and
> equity liquidity and
valuation.
Performance conditions
are set at the discretion
of the Remuneration
Committee and will
generally consist of a
mixture of:
> service requirements;
> milestone-based events,
linked to the successful
execution of GW’s
strategic plan, likely to
include items such as
positive trial results, or
regulatory approvals;
and
> market-based measures
such as absolute or
relative share price
performance.
Major shareholders may
be consulted as part of
the process of setting
performance conditions.
29
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Notes to the Policy Table
Clawback of incentives: The clawback policy provides that certain incentive compensation is recoverable from a Director if the
Company is required to restate financial statements due to the misconduct of that particular Director, and that misconduct has
significantly contributed to the need for the restatement. Generally, eligible incentive grants shall include cash short-term incentive
awards and equity-based long-term incentive awards that have been awarded and/or vested based upon achievement of specific
financial or operational goals which were deemed to have been achieved but which, following restatement, are considered to no longer
have been achieved. To be effective, intention to claw back awards which have already vested and been exercised must be notified to
the Director within 24 months of the award having vested. The Committee may effect a clawback either through a cash or equity
repayment by the individual, or via an adjustment to an outstanding award that is yet to vest or that has vested but is not yet exercised.
Equity retention policy: To encourage executives to retain a meaningful amount of equity in the Company, a retention policy is in
effect for Directors and Executive Officers. The purpose of this policy is to encourage ownership of the Company’s shares, promote
alignment of the long-term interests of the Directors and Executive Officers with those of our shareholders, and promote our
commitment to sound corporate governance. The policy is applicable to our Directors and Executive Officers, and certain other
members of our leadership team, as nominated by our Chief Executive Officer. Under the policy, covered Directors and officers must
retain an agreed proportion of each new equity grant issued to them after 1 January 2015, subject to the payment of any applicable
taxes, for a period of five years from vesting until an overall level of share ownership is achieved. The target level of ownership equates
to four times basic salary for the Chief Executive Officer and two times basic salary for the other Directors and Officers. The target
deadline for achieving the ownership requirement is intended to be five years from implementation of the policy. Existing
shareholdings or direct purchases of equity by executives shall contribute towards attainment of the targeted shareholding cap. The
Committee retains the power to consider an individual ineligible for future equity incentive grants if the required target has not been
achieved in a timely manner, subject to the consideration of individual circumstances.
General discretions relating to the operation of incentive plans: The committee will operate all incentive plans in accordance with Plan
Rules and will retain full discretion over a number of areas relating to the operation and administration of these plans. This includes,
but is not limited to, determining eligibility, setting performance conditions, determining the extent to which performance conditions
are achieved, leaver terms and the vehicle of delivery.
Summary Remuneration Policy – Non-Executive Directors
Performance
targets
Not applicable.
Maximum
The value of
individuals’
aggregate fees will
not exceed the 75th
percentile of peer
group comparator
data.
Element of
remuneration
Non-
executive
fees
Purpose and
link to strategy
Operation
Reflects time
commitments and
responsibilities of
each role.
Reflects fees paid
by similarly sized
companies.
The remuneration of the non-executive
Directors will be determined by the Board
as a whole by reference to market practice
and market data, on which the Committee
receives independent advice, and reflects
the individual’s experience, scope of the
role, time commitment and changes to the
job responsibilities.
Fees typically consist of a basic fee for
non-executive Director responsibilities
plus incremental fees for additional roles/
responsibilities such as chairmanship
of Board sub-committees, senior non-
executive Director and US representative
Director roles.
Fees can be paid in the form of cash or
shares to be held until the individual
retires from the Board. Any element of
fees paid in the form of shares will not be
subject to performance conditions.
The non-executive Directors do
not receive any pension from the
Company, nor do they participate in any
performance-related incentive plans.
All-Employee Comparison
The following differences exist between the Company’s policy for the remuneration of Directors and Executive Officers as set out
above and its approach to the payment of employees generally:
30
GW Pharmaceuticals plc | Annual Report and Accounts 2018 > Benefits offered to other employees are consistent with those offered to the Directors and Executive Officers.
> All US-based employees are entitled to a contribution from the Company towards a 401(k) scheme. This is generally at the same
level as contributions paid to the personal pension/401(k) schemes of the US-based Executive Director. UK-based employees are
entitled to a personal pension scheme contribution equating to 6.67% of basic salary. UK-based Directors do not currently receive
an employer’s pension contribution.
> All employees are able to participate in the LTIP schemes although the size of LTIP awards tends to increase with seniority as there
is a greater emphasis on performance-related pay for senior members of staff.
> A lower level of maximum annual bonus/short-term incentive opportunity typically applies to other employees.
Approach to Recruitment Remuneration
The remuneration package for a new Director or Executive Officer, to include basic salary, benefits, pension, annual bonus/short-term
incentive and long-term incentive awards, will be set in accordance with the terms of the Company’s prevailing approved
Remuneration Policy at the time of appointment. The Committee will consider the role, responsibility and experience of the candidate
and will seek independent advice and market data to help derive an appropriate level of remuneration in order to secure the right
candidate with the required skills and experience for the role.
To facilitate recruitment, the Committee may offer additional cash and/or share-based remuneration to take account of, and
compensate for, remuneration that the Director or Executive Officer is required to relinquish when leaving a former employer, or to
ensure that a fully market-competitive package is offered to the candidate. Any such offer would take into account the nature, time
horizon and performance conditions attached to any waived remuneration.
For an internal Director and Executive Officer appointment, any variable pay element awarded in respect of the prior role will be
allowed to pay out according to its terms. In addition, any other contractual remuneration obligations existing prior to appointment
may continue.
For external and internal appointments, the Committee may agree that the Group will provide reasonable relocation support. In all
cases, the Committee will ensure that decisions made are in the best interests of the Group.
The remuneration for any non-executive appointments will be set in accordance with the prevailing Remuneration Policy. Typically,
the first grant of equity-based incentive awards made after appointment of a new non-executive to the Board will be increased by 50%.
No additional cash payments will usually be made.
Service Contracts
It is Group policy that Executive Directors should have contracts with an indefinite term providing for a maximum of 12 months’
notice. New appointees to the Board are typically given a six-month notice period which can then be increased to 12 months’ notice, at
the discretion of the Remuneration Committee, once the new appointee is considered to be established within their role.
Executive Directors’ service contracts, which include details of remuneration, have been filed with the US Securities and Exchange
Commission and so are publicly available.
Details of Directors’ service contracts are as follows:
Director
Executive
Dr Geoffrey W Guy
Justin Gover
Non-executive
James Noble
Thomas Lynch
Cabot Brown
Catherine Mackey
Alicia Secor
William Waldegrave
Date of contract
Notice period
March 2013
12 months
February 2013 12 months
February 2016
February 2013
January 2016
December 2017
December 2017
December 2017
3 months
3 months
3 months
3 months
3 months
3 months
The non-executive Directors have service agreements which are subject to a three-month notice period. Their remuneration is reviewed
by the Board annually. In accordance with the Company’s Articles of Association, non-executive Directors are included in the
requirement that one-third of Directors are subject to retirement by rotation at each AGM. James Noble and Thomas Lynch will be
retiring by rotation at the next AGM and, being eligible, they will seek re-election.
31
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Remuneration Report continued
Illustrations of the Application of the Remuneration Policy – Performance and
Remuneration Scenarios
The following table and graphical illustrations provide an illustration of the potential remuneration for the year ended 31 December
2019 for each of the Directors, computed in accordance with the Remuneration Policy outlined above for each of three performance
scenarios, as follows:
The following table and graphs provide an illustration of the potential remuneration. In interpreting these scenarios it is very
important to note that it is likely that a significant proportion of future long-term equity incentive grants to the Executive Directors are
likely to consist partly of share options which will only have value to the Executive Directors if they are successful in generating share
price growth during the vesting period. The Remuneration Committee believes that this approach will align the interests of Executive
Directors with those of our shareholders. The face value of equity incentive awards shown in the graphical illustrations below is not
therefore indicative of the amount that the Directors will earn from these awards in future, as it is principally the future growth in
value of these awards that will generate a financial return for each Director:
This scenario assumes that the current basic salary for each Director is as per the Remuneration Committee
determination in February 2019 (see page 26).
The value of benefits receivable for the year ended 31 December 2019 assumed to be equal to the value of benefits
received in the year ended 31 December 2018 as set out in the single total figure of remuneration table on page 17.
The pension or 401K contribution receivable by each Director for the year ended 31 December 2018 is assumed to
be in line with the current level of contributions.
No short-term incentive payment is assumed for any Director. No vesting of long-term equity-based incentives is
assumed.
This scenario is illustrative only and is not expected to be predictive of 2019 remuneration for either of the
Executive Directors.
Fixed elements of remuneration, as set out above, plus:
On-target level of short-term incentive payment, for the Chief Executive Officer, is taken to be 60% of basic salary,
being the on-target amount for 2019.
The Chairman is no longer entitled to an annual bonus.
This scenario assumes the grant of equity-based incentives with a Black-Scholes valuation at grant equivalent
to 600% of basic salary to the CEO and 400% for the Chairman. It is then assumed that 50% of these awards
will vest. We are required to illustrate the face value of these awards, i.e. where awards consist of market-priced
option awards, the face value is derived by multiplying the number of options granted by the exercise price. For
the purposes of the illustrations below, we have assumed that the face value of options will equate to 160% of the
Black-Scholes value. This has been derived by reference to the most recent equity incentive award to the Directors
in 2018.
No account is taken of share price growth over the vesting period.
This scenario is illustrative only and is not expected to be predictive of 2019 remuneration for either of the
Executive Directors.
Fixed elements of remuneration, as set out above, plus:
On-target level of short-term incentive payment, for the Chief Executive Officer, is taken to be 150% of basic
salary, being the maximum percentage that can be awarded by the Remuneration Committee.
This scenario assumes the grant to the Chief Executive Officer, of the maximum possible number of equity-based
incentives per the above policy, being awards with a Black-Scholes valuation at grant equivalent to 600% of basic
salary under the current Remuneration Policy. For the Chairman this equivalent is set at 600% of basic salary.
We are required to illustrate the face value of these awards, i.e. where awards consist of market priced option
awards, the face value is derived by multiplying the number of options granted by the exercise price. For the
purposes of the illustrations below, we have assumed that the face value of options will equate to 160% of the
Black-Scholes value. This has been derived by reference to the most recent equity incentive award to the Directors
in 2018. For illustrative purposes, it is then assumed that 100% of these awards will vest. No account is taken of
share price growth over the vesting period.
Operation of the equity retention policy, outlined above, will also mean that Executive Directors may only be able
to realise a proportion of the illustrated incentive gains in 2019 as they are likely to be required to retain equity
shares acquired under such schemes for an extended period.
Minimum
– fixed
elements of
remuneration
Performance
in line with
expectations
Maximum
remuneration
receivable
32
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Chief Executive Officer (£000s)
Chairman (£000s)
7,000
6,000
5,000
4,000
3,000
2,000
1,000
0
£512
100%
Minimum
£6,217
78%
13%
9%
£2,550
65%
14%
21%
Future – in line
with expectations
Maximum
5,000
4,000
3,000
2,000
1,000
£417
100%
Minimum
0
£4,372
£1,405
70%
30%
Future – in line
with expectations
90%
10%
Maximum
Policy for Payments for Loss of Office
The Committee’s approach to payments in the event of termination is to take account of the individual circumstances including the
reason for termination, individual performance, contractual obligations and the terms of the LTIPs in which the Director participates.
On notice from the Company, the Company will normally continue to pay salary, pension and other benefits during the balance of the
notice period while the individual remains an employee. Although the Director employment contracts do not provide for payment in
lieu of notice, the Remuneration Committee may offer payment in lieu of notice if they consider that it is in the best interests of the
Company, subject to such payment not exceeding the contractual notice entitlement. The Committee may also approve other limited
payments in connection with a departure, which may include legal fees connected to the departure, untaken holiday/accrued vacation,
out-placement and repatriation.
There is no automatic contractual entitlement to bonus on termination although this may be considered.
Unvested LTIP awards normally lapse although the Committee retains the power to determine, in accordance with the good
leaver provisions of the LTIP scheme rules, what proportion of unvested awards will be retained and what proportion will lapse.
In determining this, the Committee will give consideration to the reason for leaving, the extent of achievement of performance
conditions at the date of leaving and may decide to time pro-rate awards.
Statement of Consideration of Employment Conditions Elsewhere in the Company
During the annual review of remuneration, the Committee considers the remuneration and terms and conditions for the broader
employee population when determining the extent of basic salary increases for the Directors. Employees have not been consulted in
respect of the design of the Company’s senior executive remuneration policy to date although the Committee will keep this under review.
Statement of Shareholder Views
The Remuneration Committee considers shareholder feedback received in relation to the Annual General Meeting (“AGM”) each year
at a meeting immediately following the AGM. This feedback, plus any additional feedback received from shareholders in respect of
remuneration matters during the financial year, is then considered as part of the Company’s annual review of remuneration policy.
Approval
This report was approved by the Board of Directors and signed on its behalf by:
Adam George
Company Secretary
28 March 2019
33
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Directors’ Responsibilities Statement
The Directors are responsible for preparing the Annual Report
and the financial statements in accordance with applicable law
and regulations.
Company law requires the Directors to prepare financial
statements for each financial year. Under that law the Directors
are required to prepare the Group financial statements in
accordance with International Financial Reporting Standards
(“IFRSs”) as adopted by the European Union, as issued by the
International Accounting Standards Board (“IASB”) and have
also chosen to prepare the Parent Company financial statements
under IFRSs as adopted by the European Union. Under Company
law the Directors must not approve the financial statements
unless they are satisfied that they give a true and fair view of the
state of affairs of the Company and of the profit or loss of the
Company for that period. In preparing these financial statements,
International Accounting Standard 1 requires that Directors:
> properly select and apply accounting policies;
> present information, including accounting policies, in a
manner that provides relevant, reliable, comparable and
understandable information;
> provide additional disclosures when compliance with the
specific requirements in IFRSs are insufficient to enable users
to understand the impact of particular transactions, other
events and conditions on the entity’s financial position and
financial performance; and
> make an assessment of the Company’s ability to continue as a
going concern.
The Directors are responsible for keeping adequate accounting
records that are sufficient to show and explain the Company’s
transactions and disclose with reasonable accuracy at any time
the financial position of the Company and enable them to ensure
that the financial statements comply with the Companies Act
2006. They are also responsible for safeguarding the assets of
the Company and hence for taking reasonable steps for the
prevention and detection of fraud and other irregularities.
The Directors are responsible for the maintenance and integrity
of the corporate and financial information included on the
Company’s website. Legislation in the UK governing the
preparation and dissemination of financial statements may differ
from legislation in other jurisdictions.
We confirm that to the best of our knowledge:
> the financial statements, prepared in accordance with the
relevant financial reporting framework, give a true and fair
view of the assets, liabilities, financial position and profit or
loss of the Company and the undertakings included in the
consolidation taken as a whole;
> the strategic report includes a fair review of the development
and performance of the business and the position of the
Company and the undertakings included in the consolidation
taken as a whole, together with a description of the principal
risks and uncertainties that they face; and
> the Annual Report and financial statements, taken as a whole,
are fair, balanced and understandable and provide the
information necessary for shareholders to assess the
Company’s position and performance, business model and
strategy.
This responsibility statement was approved by the Board of
Directors on 28 March 2019 and is signed on its behalf by:
Adam George
Company Secretary
28 March 2019
34
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Independent Auditor’s Report
For the 15-month period ended 31 December 2018
Report on the audit of the financial statements
Opinion
In our opinion:
> the financial statements of GW Pharmaceuticals plc (the ‘parent Company’) and its subsidiaries (the ‘Group’) give a true and fair
view of the state of the Group’s and of the parent Company’s affairs as at 31 December 2018 and of the Group’s loss for the
15-month period then ended;
> the Group financial statements have been properly prepared in accordance with International Financial Reporting Standards
(“IFRSs”) as adopted by the European Union and IFRSs as issued by the International Accounting Standards Board (“IASB”);
> the parent Company financial statements have been properly prepared in accordance with IFRSs as adopted by the European
Union and as applied in accordance with the provisions of the Companies Act 2006; and
> the financial statements have been prepared in accordance with the requirements of the Companies Act 2006.
We have audited the financial statements which comprise:
> the Consolidated Income Statement;
> the Consolidated Statement of Comprehensive Loss;
> the Consolidated and Parent Company Balance Sheets;
> the Consolidated and Parent Company Statements of Changes in Equity;
> the Consolidated and Parent Company Cash Flow Statements; and
> the related notes 1 to 28.
The financial reporting framework that has been applied in their preparation is applicable law and IFRSs as adopted by the European
Union and, as regards the parent Company financial statements, as applied in accordance with the provisions of the Companies Act 2006.
Basis for Opinion
We conducted our audit in accordance with International Standards on Auditing (UK) (“ISAs (UK)”) and applicable law. Our
responsibilities under those standards are further described in the auditor’s responsibilities for the audit of the financial statements
section of our report.
We are independent of the Group and the parent Company in accordance with the ethical requirements that are relevant to our audit
of the financial statements in the UK, including the Financial Reporting Council’s (the “FRC’s”) Ethical Standard as applied to listed
entities, and we have fulfilled our other ethical responsibilities in accordance with these requirements. We believe that the audit
evidence we have obtained is sufficient and appropriate to provide a basis for our opinion.
Summary of our audit approach
Key audit matter
Materiality
Scoping
The key audit matter that we identified in the current year was related to the date at which Epidiolex inventory
could start to be capitalised and the appropriateness of the methodology to determine the inventory cost
associated with each stage of production. Epidiolex inventory was not included in the comparative balance sheet
at 30 September 2017, but has been capitalised for the first time during this 15-month reporting period to
31 December 2018.
The materiality that we used for the Group financial statements in the current year was $10,200,000 which was
determined based on a blended measure including net cash flows from operations and total operating expenses
benchmarks.
The audit of the parent company was performed by the UK Group audit team. The other significant components
of the Group were subject to full scope audits, with work performed by both the UK Group audit team and
component auditors in the USA. This distribution of work was a change from the prior period. The four
components detailed further below account for 99% of the Group’s loss before tax, 99% of the Group’s net
assets and 100% of the Group’s revenue.
Significant changes
in our approach
The key audit matter identified in the current period is different to prior year, as discussed in further detail
below. We have involved a component auditor in performing our audit procedures to support the opinion for the
15-month period ended 31 December 2018.
35
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Independent Auditor’s Report continued
Conclusions Relating to Going Concern
We are required by ISAs (UK) to report in respect of the following matters where:
> the Directors’ use of the going concern basis of accounting in preparation of the financial
statements is not appropriate; or
> the Directors have not disclosed in the financial statements any identified material uncertainties
that may cast significant doubt about the Group’s or the parent company’s ability to continue to
adopt the going concern basis of accounting for a period of at least 12 months from the date
when the financial statements are authorised for issue.
We confirm that we have
nothing material to report,
add or draw attention to in
respect of these matters.
Key Audit Matters
A key audit matter is a matter that, based on professional judgement, was of most significance in our audit of the financial statements
for the current period and includes the most significant assessed risk of material misstatement (whether or not due to fraud) that we
identified. Key audit matters included those which had the greatest effect on: the overall audit strategy, the allocation of resources in
the audit; and directing the efforts of the engagement team.
The matter set out below was addressed in the context of our audit of the financial statements as a whole, and in forming our opinion
thereon, and we do not provide a separate opinion on this matter.
The key audit matter in the current period is related to Epidiolex inventory which is a new balance in the period. The prior year key
audit matter on Research and Development (R&D) activity related to HMRC’s small or medium-sized enterprises (“SME”) scheme is
not applicable as at 31 December 2018 as the Company no longer qualifies for the scheme.
Epidiolex inventory
Key audit matter
description
How the scope of our
audit responded to the
key audit matter
Management determined that Epidiolex inventory costs should be capitalised from the date the US
Food and Drug Administration (FDA) accepted the Epidiolex New Drug Application (NDA) on
27 December 2017. This is a material judgement that impacts the value of Epidiolex inventory at
31 December 2018. The Epidiolex balance at 31 December 2018 is $44.4 million (2017: $nil).
The key audit matter is in relation to the date at which Epidiolex inventory could start to be capitalised
and the methodology to determine the inventory cost associated with each stage of production.
Management determined the actual cost of producing Epidiolex for the period from 27 December
2017 to 31 December 2018. The method includes detailed analysis of the actual costs incurred in
production and, in particular, the basis for absorbing the costs based on the number of batches,
inventory stage and buildings.
Management then determined the actual cost of the Epidiolex inventory balance at 31 December
2018 by applying the valuation principles in accordance with IAS 2 to the inventory produced after
27 December 2017.
In responding to this key audit matter associated with Epidiolex inventory the following procedures
were undertaken to challenge management’s position and outcome:
> Assessment of the Epidiolex capitalisation date in line with IAS 2 Inventories;
> Assessment of the methodology applied by management in determining the cost of each bottle of
Epidiolex;
> A detailed test on the batches of Epidiolex at different production stages to determine that only
batches produced after 27 December 2017 were included in the inventory value at 31 December
2018;
> Testing that the capitalised costs were appropriate and valid by tracing a sample of costs to
supporting evidence;
> Testing that the capitalised costs were appropriately capitalised in accordance with the
requirements of IAS 2;
> Key controls implemented by management to address the risk of material misstatements were
identified. The design and implementation were assessed, and operating effectiveness of the
controls was tested.
Key observations
Based on the procedures performed, we concluded that the capitalisation date and the methodology
applied to calculate the cost of Epidiolex inventory are appropriate.
36
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Our Application of Materiality
We define materiality as the magnitude of misstatement in the financial statements that makes it probable that the economic decisions
of a reasonably knowledgeable person would be changed or influenced. We use materiality both in planning the scope of our audit
work and in evaluating the results of our work.
Based on our professional judgement, we determined materiality for the financial statements as a whole as follows:
Materiality
$10,200,000 (2017: $6,300,000)
$10,100,000 (2017: $5,700,000)
Group financial statements
Parent company financial statements
The large movement in comparison to prior year
is primarily due to the current period materiality
being calculated based on 15-month period totals.
The large movement in comparison to prior year
is primarily due to the current period materiality
being calculated based on increased total assets
in the 15-month period.
Basis for determining
materiality
We determined materiality based on a
combination of benchmarks including net cash
flows from operations and total operating
expenses. Our materiality of $10,200,000
represents 3.4% of total operating expenditure
and 4.4% of net cash flows from operations.
We determined materiality based on 2% of
total assets.
Rationale for the benchmark
applied
We believe that a combination of total operating
expenditure and net cash flows from operations
is reflective of the relevant benchmarks for
stakeholders in assessing the performance of
the Group.
Total assets has been used as this is a non-
trading holding company and we consider this
to be the most appropriate basis. We have
capped this at 99% of Group materiality.
The value of the Group is derived from
successful research and development, with a
significant proportion of the value derived from
the commercialisation of Epidiolex.
We have agreed with the Audit Committee that we would report to the Committee all audit differences in excess of $514,000, as well
as differences below that threshold that, in our view, warranted reporting on qualitative grounds. We also report to the Audit
Committee on disclosure matters that we identified when assessing the overall presentation of the financial statements.
An Overview of the Scope of Our Audit
Our Group audit was scoped by obtaining an understanding of the Group and its environment, including Group-wide controls, and
assessing the risks of material misstatement at the Group level sufficient to give reasonable assurance that the financial statements are
free from material misstatement.
We performed full scope audits on four significant components of the Group, located in the UK and the USA, using component
materialities that are lower than Group materiality:
> The parent company – GW Pharmaceuticals plc (component materiality: $10,100,000)
> GW Pharma Limited (“GWP”) – responsible for Epidiolex manufacturing activities (component materiality: $6,200,000)
> GW Research Limited (“GWR”) – responsible for research and development activities (component materiality: $8,200,000)
> Greenwich Biosciences, Inc (“GBI”) – which is expanding significantly to facilitate commercialisation of Epidiolex (component
materiality: $8,200,000).
These four significant components cover 100% of the Group’s revenue, 99% of the Group’s loss before tax and 99% of the Group’s net assets.
At the parent entity level, we also tested the consolidation process and carried out analytical procedures to confirm our conclusion
that there were no significant risks of material misstatements of the aggregated financial information of the remaining components not
subject to audit.
In audits for previous periods all work was performed by the UK group engagement team. In the current year, the UK group team
engaged component auditors in the US in regard to GBI, GWP and GWR.
37
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Independent Auditor’s Report continued
The group team prepared the overall audit strategy, materiality, risk assessment and provided detailed instructions to the component
auditor including which aspects of each component’s audit work were to be performed by which team.
The group team visited the component auditor in the US to perform a detailed workpaper review and to discuss significant audit
matters. Telephone conference meetings were also held with the component auditor throughout the audit.
Other Information
The Directors are responsible for the other information. The other information comprises the
information included in the Annual Report, other than the financial statements and our auditor’s
report thereon.
We have nothing to report in
respect of these matters.
Our opinion on the financial statements does not cover the other information and, except to the
extent otherwise explicitly stated in our report, we do not express any form of assurance
conclusion thereon.
In connection with our audit of the financial statements, our responsibility is to read the other
information and, in doing so, consider whether the other information is materially inconsistent
with the financial statements or our knowledge obtained in the audit or otherwise appears to be
materially misstated.
If we identify such material inconsistencies or apparent material misstatements, we are required to
determine whether there is a material misstatement in the financial statements or a material
misstatement of the other information. If, based on the work we have performed, we conclude that
there is a material misstatement of this other information, we are required to report that fact.
Responsibilities of Directors
As explained more fully in the Directors’ responsibilities statement, the Directors are responsible for the preparation of the financial
statements and for being satisfied that they give a true and fair view, and for such internal control as the Directors determine is
necessary to enable the preparation of financial statements that are free from material misstatement, whether due to fraud or error.
In preparing the financial statements, the Directors are responsible for assessing the Group’s and the parent Company’s ability to
continue as a going concern, disclosing as applicable, matters related to going concern and using the going concern basis of accounting
unless the Directors either intend to liquidate the Group or the parent Company or to cease operations, or have no realistic alternative
but to do so.
Auditor’s Responsibilities for the Audit of the Financial Statements
Our objectives are to obtain reasonable assurance about whether the financial statements as a whole are free from material misstatement,
whether due to fraud or error, and to issue an auditor’s report that includes our opinion. Reasonable assurance is a high level of assurance,
but is not a guarantee that an audit conducted in accordance with ISAs (UK) will always detect a material misstatement when it exists.
Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be
expected to influence the economic decisions of users taken on the basis of these financial statements.
A further description of our responsibilities for the audit of the financial statements is located on the FRC’s website at: www.frc.org.uk/
auditorsresponsibilities. This description forms part of our auditor’s report.
38
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Report on other legal and regulatory requirements
Opinions on other matters prescribed by the Companies Act 2006.
In our opinion the part of the Directors’ Remuneration Report to be audited has been properly prepared in accordance with the
Companies Act 2006.
In our opinion, based on the work undertaken in the course of the audit:
> the information given in the Strategic Report and the Directors’ Report for the financial year for which the financial statements are
prepared is consistent with the financial statements; and
> the Strategic Report and the Directors’ Report have been prepared in accordance with applicable legal requirements.
In the light of the knowledge and understanding of the Group and the parent Company and their environment obtained in the course
of the audit, we have not identified any material misstatements in the Strategic Report or the Directors’ Report.
Matters on which we are required to report by exception
Adequacy of explanations received and accounting records
Under the Companies Act 2006 we are required to report to you if, in our opinion:
> we have not received all the information and explanations we require for our audit; or
> adequate accounting records have not been kept by the parent Company, or returns adequate
for our audit have not been received from branches not visited by us; or
> the parent Company financial statements are not in agreement with the accounting records
and returns.
We have nothing to report in
respect of these matters.
Directors’ remuneration
Under the Companies Act 2006 we are also required to report if in our opinion certain
disclosures of Directors’ remuneration have not been made or the part of the Directors’
Remuneration Report to be audited is not in agreement with the accounting records and returns.
We have nothing to report in
respect of this matter.
Use of our report
This report is made solely to the Company’s members, as a body, in accordance with Chapter 3 of Part 16 of the Companies Act 2006.
Our audit work has been undertaken so that we might state to the Company’s members those matters we are required to state to them
in an auditor’s report and for no other purpose. To the fullest extent permitted by law, we do not accept or assume responsibility to
anyone other than the Company and the Company’s members as a body, for our audit work, for this report, or for the opinions we
have formed.
David Hedditch
(Senior statutory auditor)
For and on behalf of Deloitte LLP
Statutory Auditor
London, United Kingdom
28 March 2019
39
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Consolidated Income Statements
For the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
Revenue
Cost of sales
Research and development expenditure
Sales, general and administrative expenses
Net foreign exchange loss
Operating loss
Interest expense
Interest and other income
Loss before tax
Tax (charge)/benefit
Loss for the period
Loss per share – basic
Loss per share – diluted
15 months to
31 December
2018
$000s
Restated
12 months to
30 September
2017
$000s
19,391
(7,912)
10,519
(4,521)
(167,142) (142,022)
(187,602)
(53,243)
(2,666)
(6,442)
(345,931)
(1,573)
11,155
(195,709)
(951)
2,063
Notes
3
4
9
9
5 (336,349) (194,597)
26,452
10
(5,090)
(341,439)
(100.3)c
(168,145)
(55.4)c
(100.3)c
(55.4)c
11
11
The accompanying notes are an integral part of these Consolidated Income Statements.
All activities relate to continuing operations.
Consolidated Statements of Comprehensive Loss
For the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
Loss for the period
Items that may be reclassified subsequently to profit or loss
Exchange differences on translation of foreign operations
Other comprehensive (loss)/gain for the period
Total comprehensive loss for the period
The accompanying notes are an integral part of these Consolidated Statements of Comprehensive Loss.
No tax arises relating to components of other comprehensive (loss)/gain.
15 months to
31 December
2018
$000s
Restated
12 months to
30 September
2017
$000s
(341,439)
(168,145)
(9,210)
(9,210)
9,728
9,728
(350,649)
(158,417)
40
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Consolidated Statement of Changes in Equity
For the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
Group
Balance at 1 October 2016 (restated)
Loss for the year
Other comprehensive gain
Total comprehensive loss for the year
Exercise of share options (note 22)
Share-based payment transactions
Deferred tax attributable to unrealised share option gains
Balance at 30 September 2017 (restated)
Loss for the period
Other comprehensive loss
Total comprehensive loss for the period
Impact of adoption of IFRS 15 on opening accumulated deficit
Issue of share capital (note 22)
Expenses of new equity issue
Exercise of share options (note 22)
Share-based payment transactions
Deferred tax attributable to unrealised share option gains
Share
Capital
$000s
480
–
–
Share
Premium
Account
$000s
837,374
–
–
Merger
Reserve
$000s
31,119
–
–
Foreign
Exchange
Reserve
$000s
Accumulated
Deficit
$000s
Total
Equity
$000s
(81,134) (273,278) 514,561
(168,145)
(168,145)
9,728
–
–
9,728
–
3
–
–
483
–
–
–
–
79
–
2
–
–
–
119
–
–
837,493
–
–
–
–
624,968
(2,475)
616
–
–
–
–
–
–
9,728 (168,145) (158,417)
122
15,143
171
–
15,143
171
–
–
–
31,119
–
–
(71,406) (426,109) 371,580
(341,439)
(341,439)
(9,210)
–
–
(9,210)
–
–
–
–
–
–
–
(9,210) (341,439) (350,649)
7,433
7,433
625,047
–
(2,475)
–
618
–
40,520
40,520
(123)
(123)
–
–
–
–
–
–
Balance at 31 December 2018
564 1,460,602
31,119
(80,616) (719,718) 691,951
41
GW Pharmaceuticals plc | Annual Report and Accounts 2018
Company Statement of Changes in Equity
or the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
Company
Balance at 1 October 2016 (restated)
Profit for the year
Other comprehensive gain
Total comprehensive gain for the year
Exercise of share options (note 22)
Share-based payment transactions
Balance at 30 September 2017 (restated)
Profit for the period
Other comprehensive loss
Total comprehensive loss for the period
Issue of share capital (note 22)
Expenses of new equity issue
Exercise of share options (note 22)
Share-based payment transactions
Balance at 31 December 2018
Share
Capital
$000s
480
–
–
–
3
–
483
–
–
–
79
–
2
–
Share
Premium
Account
$000s
Foreign
Exchange
Reserve
$000s
Accumulated
Profit
$000s
Total
Equity
$000s
837,374 (142,294) 150,813
9,910
–
–
30,323
–
–
–
119
–
30,323
–
–
9,910
–
15,143
837,493 (111,971) 175,866
17,772
–
–
(22,399)
–
–
–
624,968
(2,475)
616
–
(22,399)
–
–
–
–
17,772
–
–
–
40,520
846,373
9,910
30,323
40,233
122
15,143
901,871
17,772
(22,399)
(4,627)
625,047
(2,475)
618
40,520
564 1,460,602 (134,370) 234,158 1,560,954
The accompanying notes are an integral part of these consolidated and Company Statements of Changes in Equity.
42
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Consolidated and Company Balance Sheets
As at 31 December 2018 and 30 September 2017
Non-current assets
Intangible assets – goodwill
Other intangible assets
Investments
Property, plant and equipment
Deferred tax asset
Current assets
Inventories
Taxation recoverable
Trade receivables and other current assets
Cash and cash equivalents
Total assets
Current liabilities
Trade and other payables
Current tax liabilities
Obligations under finance leases
Deferred revenue
Non-current liabilities
Trade and other payables
Obligations under finance leases
Deferred revenue
Total liabilities
Net assets
Equity
Share capital
Share premium account
Merger reserve
Foreign exchange reserve
Accumulated (deficit)/profit
Total equity
12
13
27
14
10
15
10
16
21
17
10
19
20
17
19
20
31 December
2018
$000s
Notes
Group
Restated
30 September
2017
$000s
6,959
2,417
–
89,430
8,380
107,186
6,959
1,401
–
58,328
8,391
75,079
Restated
1 October
2016
$000s
6,728
812
–
50,291
5,001
Company
Restated
30 September
2017
$000s
Restated
1 October
2016
$000s
31 December
2018
$000s
–
–
837,447
–
–
–
–
584,283
–
–
–
–
393,875
–
–
62,832
837,447
584,283
393,875
51,007
4,833
19,424
591,497
5,669
26,812
14,983
322,154
5,485
27,533
5,883
483,445
–
–
183,876
544,196
–
–
61,202
257,538
–
–
30,127
423,122
666,761
369,618
522,346
728,072
318,740
453,249
773,947
444,697
585,178 1,565,519 903,023
847,124
(63,586)
(2,391)
(400)
–
(44,236)
(1,119)
(274)
(3,082)
(40,251)
(1,140)
(272)
(3,468)
(4,565)
–
–
–
(66,377)
(48,711)
(45,131)
(4,565)
(1,152)
–
–
–
(1,152)
(9,929)
(5,690)
–
(12,364)
(6,352)
(5,690)
(12,168)
(6,403)
(6,915)
–
–
–
–
–
–
(751)
–
–
–
(751)
–
–
–
(81,996)
(73,117)
(70,617)
(4,565)
(1,152)
(751)
691,951
371,580
514,561 1,560,954 901,871
846,373
22
24
24
564
1,460,602
31,119
(80,616)
(719,718)
483
837,493
31,119
(71,406)
(426,109)
480
564
837,374 1,460,602
–
31,119
(81,134) (134,370)
(273,278) 234,158
483
837,493
–
(111,971)
175,866
480
837,374
–
(142,294)
150,813
691,951
371,580
514,561 1,560,954 901,871
846,373
The financial statements of GW Pharmaceuticals plc, registered number 04160917, on pages 40 to 77 were authorised by the Board
and approved for issue on 28 March 2019.
No income statement or statement of comprehensive income is presented for GW Pharmaceuticals plc as permitted by Section 408 of
the Companies Act 2006. The Company’s profit for the 15-month period ended 31 December 2018 was $17,772,000 (year ended
30 September 2017: $9,910,000).
The accompanying notes are an integral part of these Consolidated and Company Balance Sheets.
By order of the Board.
Adam George
Company Secretary
28 March 2019
43
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Consolidated and Company Cash Flow Statements
For the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
(Loss)/profit for the period/year
Adjustments for:
Interest expense
Interest and other income
Tax charge/(benefit)
Depreciation of property, plant and equipment
Impairment of property, plant and equipment
Reversal of impairment of property, plant and equipment
Amortisation of intangible assets
Net foreign exchange losses
Increase in provision for inventories
Decrease in deferred signature fees
Share-based payment charge
Loss on disposal of property, plant and equipment
Increase in inventories
Increase in trade receivables and other current assets
Increase in trade and other payables and deferred revenue
Cash used in operations
Income taxes paid
Research and development tax credits received
Net cash outflow from operating activities
Investing activities
Interest received
Increase in loan to subsidiary
Purchase of property, plant and equipment
Purchase of intangible assets
Proceeds from sale of property, plant and equipment
Net cash outflow from investing activities
Financing activities
Proceeds on exercise of share options
Proceeds of new equity issue
Expenses of new equity issue
Interest paid
Repayments of fit out funding
Repayments of obligations under finance leases
Net cash inflow/(outflow) from financing activities
Effect of foreign exchange rate changes
Net increase/(decrease) in cash and cash equivalents
Cash and cash equivalents at the beginning of the period/year
Cash and cash equivalents at end of the period/year
Group
Company
15 months to
31 December
2018
$000s
Restated
12 months to
30 September
2017
$000s
15 months to
31 December
2018
$000s
Restated
12 months to
30 September
2017
$000s
(341,439)
(168,145)
17,772
9,910
1,573
(11,155)
5,090
10,626
–
–
1,118
2,666
1,405
(1,178)
40,520
361
951
(2,063)
(26,452)
6,739
809
(276)
313
6,442
133
(1,750)
15,143
801
–
(5,932)
–
–
–
–
–
3,188
–
–
778
–
–
(2,002)
–
–
–
–
–
6,253
–
–
–
–
(290,413)
(47,025)
(9,254)
21,808
(167,355)
(128)
15,806
–
(3,877) (125,715)
3,168
5,755
14,161
–
(30,037)
546
(324,884) (165,605)
(106,741)
(15,330)
(3,703)
27,168
(2,906)
27,746
–
–
–
–
(301,419) (140,765)
(106,741)
(15,330)
5,190
–
(44,934)
(2,194)
517
1,830
5,153
2,002
– (224,420) (153,894)
–
–
–
–
–
–
(20,941)
(826)
–
(41,421)
(19,937) (219,267) (151,892)
618
625,047
(2,475)
(1,533)
(651)
(216)
620,790
(8,607)
122
–
(171)
(1,232)
(1,074)
(267)
618
625,047
(2,475)
–
–
–
122
–
(171)
–
–
–
(2,622) 623,190
(10,524)
2,033
(49)
1,687
269,343
322,154
(161,291) 286,658 (165,584)
257,538
423,122
483,445
591,497
322,154
544,196
257,538
The accompanying notes are an integral part of these Consolidated and Company Cash Flow Statements.
44
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Notes to the Consolidated Financial Statements
For the 15 months ended 31 December 2018 and 12 months ended 30 September 2017
1. General Information
GW Pharmaceuticals plc (the “Company”) and its subsidiaries (the “Group”) are primarily involved in the development of cannabinoid
prescription medicines using botanical extracts derived from the Cannabis plant. The Group is developing a portfolio of cannabinoid
medicines, of which the lead product is Epidiolex®, an oral medicine for the treatment of refractory childhood epilepsies.
The Company is a public limited company, which has had American Depository Receipts (“ADRs”) registered with the US Securities
and Exchange Commission (“SEC”) and has been listed on NASDAQ since 1 May 2013. The Company is incorporated and domiciled
in the United Kingdom. The address of the Company’s registered office and principal place of business is Sovereign House, Vision
Park, Histon, Cambridgeshire, CB24 9BZ, United Kingdom.
The Company has elected to modify its financial year end to 31 December from 30 September and presents 15-month results to
31 December 2018. This is to align with the Group’s external financial reporting calendar. Consequently, the amounts presented in
these financial statements may not be entirely comparable.
2. Significant Accounting Policies
The principal Group accounting policies are summarised below.
Basis of Accounting
The financial statements have been prepared in accordance with International Financial Reporting Standards (“IFRS”) as endorsed by
the European Union and as issued by the International Accounting Standards Board (“IASB”). The Group financial statements also
comply with Article 4 of the European Union IAS regulation.
The financial statements have been prepared under the historical cost convention. Historical cost is generally based on the fair value of
the consideration given in exchange for the assets and received for the liabilities. The principal accounting policies are set out below.
Going Concern
At 31 December 2018 the Group had cash and cash equivalents of $591.5 million (30 September 2017: $322.2 million). The Directors
have considered the financial position of the Group, its cash position and forecast cash flows for the 12-month period from the date of
this report when considering going concern. They have also considered the Group’s key risks and uncertainties affecting the likely
development of the business. In the light of this review, the Directors have a reasonable expectation that the Company and the Group
have adequate resources to continue in operational existence for at least a 12-month period from the date of this Report. Accordingly,
they continue to adopt the going concern basis in preparing these financial statements.
Basis of Consolidation
The consolidated financial statements incorporate the financial statements of the Company and entities controlled by the Company
(its subsidiaries) made up to 31 December. Subsidiaries are all entities over which the Group has the power to govern the financial and
operating policies of the entity concerned, generally accompanying a shareholding of more than one half of the voting rights.
The results of subsidiaries acquired or disposed of during the period are included in the consolidated income statement from the
effective date of acquisition or up to the effective date of disposal, as appropriate. Where necessary, adjustments are made to the
financial statements of subsidiaries to bring the accounting policies used into line with those used by the Group. All intra-Group
transactions, balances, income and expenses are eliminated on consolidation. Acquisitions are accounted for under the acquisition
method.
In future business combinations, if a non-controlling interest in a subsidiary arises, such non-controlling interest will be identified
separately from the Group’s equity therein. The interests of non-controlling shareholders that are present ownership interests entitling
their holders to a proportionate share of net assets upon liquidation may initially be measured at fair value or at the non-controlling
interests’ proportionate share of the fair value of the acquiree’s identifiable net assets. The choice of measurement is made on an
acquisition-by-acquisition basis. Other non-controlling interests are initially measured at fair value. Subsequent to acquisition, the
carrying amount of non-controlling interests is the amount of those interests at initial recognition plus the non-controlling interests’
share of subsequent changes in equity. Total comprehensive income is attributed to non-controlling interests even if this results in the
non-controlling interests having a deficit balance.
45
GW Pharmaceuticals plc | Annual Report and Accounts 2018 2. Significant Accounting Policies continued
Changes in the Group’s interests in subsidiaries that do not result in a loss of control are accounted for as equity transactions. The
carrying amount of the Group’s interests and the non-controlling interests are adjusted to reflect the changes in their relative interests
in the subsidiaries. Any difference between the amount by which the non-controlling interests are adjusted and the fair value of the
consideration paid or received is recognised directly in equity and attributed to the owners of the Company.
When the Group loses control of a subsidiary, the profit or loss on disposal is calculated as the difference between (i) the aggregate of
the fair value of the consideration received and the fair value of any retained interest and (ii) the previous carrying amount of the assets
(including goodwill), less liabilities of the subsidiary and any non-controlling interests. Amounts previously recognised in other
comprehensive income in relation to the subsidiary are accounted for (i.e. reclassified to profit or loss or transferred directly to
accumulated deficit) in the same manner as would be required if the relevant assets or liabilities are disposed of. The fair value of any
investment retained in the former subsidiary at the date when control is lost is regarded as the fair value on initial recognition for
subsequent accounting under IAS 39 Financial Instruments: Recognition and Measurement or, when applicable, the costs on initial
recognition of an investment in an associate or jointly controlled entity.
Change of presentation currency
On 1 October 2017, the Group changed its presentation currency from Sterling to US dollars. This change has been made
retrospectively and the 2017 full year financial statements have been restated using the following procedures:
> Assets and liabilities were translated into US dollars at closing rates of exchange;
> Income and expenses were translated into US dollars at average rates of exchange;
> Differences resulting from the retranslation were taken to reserves;
> Share capital, share premium, other reserves were translated at historic rates prevailing at the dates of transactions.
In accordance with the requirements of IAS 1 Presentation of Financial Statements, a transition balance sheet as of 1 October 2016 has
been included within the primary financial statements.
Change of functional currency
IAS 21 The effects of changes in foreign exchange rates describes functional currency as ‘the currency of the primary economic
environment in which an entity operates.’ Determining when the functional currency of an entity has changed is a matter of judgement
as the determining factors may move gradually over time. The Board has concluded that the functional currency of the Company,
under IFRS reporting standards, changed from Sterling to US dollars with effect from 1 July 2018.
The main reasons for the change were:
> Approval of Epidiolex by the US Federal Drug Administration and the start of Epidiolex commercial sales during the period
indicate that the majority of the Group’s commercial activity will be driven by the US pharmaceutical market. This approval was
received in June 2018;
> A change in the Board structure during the period resulted in the Group no longer meeting the requirements for Foreign Private
Issuer (FPI) status with the US Securities and Exchange Commission per the assessment as of 31 March 2018. The majority of the
Group’s Board are now located in the United States; and
> All of the Group’s equity fundraising activity since 2013 has been denominated in US dollars and driven by the Company’s US
Nasdaq listing. The Company is solely listed on the US Nasdaq market, and so any potential future equity fundraising would most
likely be denominated in US dollars.
In accordance with IAS 21, the change in functional currency has been applied prospectively from 1 July 2018.
Intangible Assets – Other
Other intangible assets are stated at cost less provisions for amortisation and impairments. Licences, patents, know-how, software and
marketing rights separately acquired or acquired as part of a business combination are amortised over their estimated useful lives
using the straight-line basis from the time they are available for use. The estimated useful lives for determining the amortisation take
into account patent lives and related product application, but do not exceed their lifetime. Asset lives are reviewed annually and
adjusted where necessary. Contingent milestone payments are recognised at the point that the contingent event becomes certain. Any
subsequent development costs incurred by the Group and associated with acquired licences, patents, know-how or marketing rights
are written off to the income statement when incurred, unless the criteria for recognition of an internally generated intangible asset are
met, usually when a regulatory filing has been made in a major market and approval is considered highly probable.
Amortisation is provided so as to write off the cost of assets, less their estimated residual values, over their useful lives using the
straight-line method, as follows:
Software
Licences
3 years
3 years or term of licence if longer
46
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 Revenue
The Company has adopted IFRS 15: Revenue from Contracts with Customers (“IFRS 15”), and all the related amendments to all
contracts using the modified approach. As required by the modified implementation method, revenue for the current period is
accounted for under the new guidance. The comparative revenue is not restated for the impact of adopting IFRS 15; instead the current
period opening balances are adjusted for the cumulative impact of adopting IFRS 15. Certain practical expedients prescribed in IFRS
15 were utilised in the adoption of IFRS 15, including using historical experience to calculate transaction price for the Group’s revenue
contracts. Under IFRS 15, an entity recognises revenue when its customer obtains control of promised goods or services, in an amount
that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue
recognition for arrangements that an entity determines are within the scope of IFRS 15, the entity performs the following five steps: (i)
identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price;
(iv) allocate the transaction price to the performance obligations in the contract; and (v) recognise revenue when (or as) the entity
satisfies a performance obligation. The Group only applies the five-step model to contracts when it is probable that the entity will
collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once
the contract is determined to be within the scope of IFRS 15, the Group assesses the goods or services promised within each contract
and determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Group
then recognises as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as)
the performance obligation is satisfied.
Product Sales
The Group’s product sales consist of sales of Epidiolex, which was FDA approved for sale in the United States during the current
accounting period for use in treating Dravet syndrome and Lennox-Gastaut syndrome, two severe paediatric forms of Epilepsy.
Product sales revenue relating to Epidiolex shipments is recognised when shipped.
Product sales also consist of sales of Sativex®, which is currently being commercialised for spasticity due to multiple sclerosis (“MS”)
outside the United States. The Company has entered into license agreements for the commercialisation of Sativex with Almirall S.A.
(“Almirall”), in Europe (excluding the United Kingdom) and Mexico; Bayer HealthCare AG (“Bayer”) in the United Kingdom and
Canada; Ipsen Biopharm Ltd (“Ipsen”), in Latin America (excluding Mexico and the Islands of the Caribbean); and Neopharm Group
(“Neopharm”) in Israel. Under these license agreements, the Group sells fully labelled Sativex vials to its commercial partners for a
contractually agreed price, which is generally based on percentages of the commercial partners’ in-market net selling price charged to
end customers. Product sales revenue related to Sativex shipments to commercial license partners is recognised when shipped, at
which point the customer obtains control of the product. The Group commercialises Sativex in Australia and New Zealand through a
consignment relationship with a local distributor. Product sales revenue related to Sativex sales in Australia and New Zealand are
recognised when the product is sold through to the end customer.
Revenue for the Group’s product sales has not been adjusted for the effects of a financing component as the Group expects, at contract
inception, that the period between when the Group transfers control of the product and when the Group receives payment will be one
year or less. Product shipping and handling costs are included in cost of product sales.
For sales of Epidiolex, consistent with industry practice, limited product return rights for damages, shipment errors, and expiring
product; provided that the return is within a specified period around the product expiration date as set forth in the applicable individual
distribution agreement. We do not allow product returns for a product that has been dispensed to a patient. We are able to make a
reasonable estimate of future potential product returns based on on-hand channel inventory data and sell-through data. In arriving at our
estimate, we also consider historical product returns, the underlying product demand, and industry data specific to the speciality
pharmaceutical distribution industry.
The Group maintains a rebate provision for expected reimbursements to our commercial partners in circumstances in which actual net
revenue per vial differs from expected net revenue per vial as a consequence of, as an example, ongoing pricing negotiations with local
health authorities. The amount of our rebate provision is based on, amongst other things, monthly unit sales and in-market sales data
received from commercial partners and represents management’s best estimate of the rebate expected to be required to settle the present
obligation at the end of the reporting period. Provisions for rebates are established in the same period that the related sales are recorded.
Other Revenue
The Group’s other revenue primarily consists of research and development fee revenue for research and development services provided
under a Sativex development agreement with Otsuka Pharmaceutical Co. Ltd (“Otsuka”) that was terminated in December 2017 and
variable consideration milestone payments related to the Sativex license agreements.
The research and development fee revenue is recognised at the time the underlying services are performed.
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GW Pharmaceuticals plc | Annual Report and Accounts 2018 2. Significant Accounting Policies continued
The Sativex license agreements contain provisions for the Group to earn variable consideration in the form of regulatory milestone
payments, sales-based milestone payments, and royalty payments. The Group has no further performance obligations related to the
regulatory milestone payments and these amounts are recognised in accordance with IFRS 15 when receipt of these payments becomes
probable and there is no significant risk of revenue reversal. Revenue related to the sales-based milestone payments and product royalty
payments are subject to the sales-based royalty exception under IFRS 15 and will be recognised when the underlying sales are made.
Research and Development
Expenditure on research and development activities is recognised as an expense in the period in which it is incurred prior to achieving
regulatory approval.
An internally generated intangible asset arising from the Group’s development activities is recognised only if the following conditions
can be demonstrated:
> the technical feasibility of completing the intangible asset so that it will be available for use or sale;
> the intention to complete the intangible asset and use or sell it;
> the ability to use or sell the intangible asset;
> how the intangible asset will generate probable future economic benefits;
> the availability of adequate technical, financial and other resources to complete the development and to use or sell the intangible
asset; and
> the ability to measure reliably the expenditure attributable to the intangible asset during its development.
The Group has determined that regulatory approval is the earliest point at which the probable threshold can be achieved. All research
and development expenditure incurred prior to achieving regulatory approval is therefore expensed as incurred.
Borrowing Costs
Borrowing costs directly attributable to the acquisition, construction or production of qualifying assets, which are assets that
necessarily take a substantial period of time to get ready for their intended use or sale, are added to the cost of those assets, until such
time as the assets are substantially ready for their intended use or sale. All other borrowing costs are recognised in the income
statement using the effective interest method.
Property, Plant and Equipment
Property, plant and equipment are stated at cost, net of accumulated depreciation and any recognised impairment loss. Depreciation is
provided so as to write off the cost of assets, less their estimated residual values, over their useful lives using the straight-line method,
as follows:
Leasehold buildings
Plant, machinery and lab equipment
Office and IT equipment
Leasehold improvements
20 years or term of lease if shorter
3 to 20 years
3 to 5 years
4 to 20 years or term of the lease if shorter
Assets under finance leases are depreciated over their expected useful lives on the same basis as owned assets or, where shorter, over
the term of the relevant lease.
No depreciation is provided on assets under the course of construction. Cost includes professional fees and, for qualifying assets,
borrowing costs capitalised in accordance with the Group’s accounting policy. Depreciation on these assets commences when the
assets are available for use.
The gain or loss arising on disposal or scrappage of an asset is determined as the difference between the sales proceeds and the
carrying amount of the asset and is recognised in operating profit/loss.
Property, plant and equipment assets are classified as assets held-for-sale when their carrying amount is to be recovered principally
through a sale transaction and a sale is considered highly probable in its current condition. They are stated at the lower of carrying
amount and fair value less costs to sell. Depreciation is not recorded on assets classified as held-for-sale.
Investments in Subsidiary Companies
Investments are shown at cost less any provision for impairment. Investments in subsidiary companies which are accounted for under
merger accounting principles are shown at the nominal value of shares issued in accordance with the provisions of Section 131 of the
Companies Act 2006.
The carrying value of investments in subsidiary companies in the Company balance sheet is increased annually by the value of the
capital contribution deemed to have been made by the Company in its subsidiary by the grant of equity-settled share-based payments
to the employees of the subsidiary company. The value attributable to these equity-settled share-based payments is calculated in
accordance with IFRS 2 Share-based Payments.
48
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018
Inventories
Inventories are stated at the lower of cost and net realisable value. Cost is calculated using the weighted average cost method. Cost
includes materials, direct labour, depreciation of manufacturing assets and an attributable proportion of manufacturing overheads
based on normal levels of activity. Net realisable value is the estimated selling price, less all estimated costs of completion and costs to
be incurred in marketing, selling and distribution.
If net realisable value is lower than the carrying amount, a write-down provision is recognised for the amount by which the carrying
amount exceeds its net realisable value.
Inventories manufactured prior to regulatory approval are capitalised as an asset but provided for until there is a high probability of
regulatory approval of the product. At the point when a high probability of regulatory approval is obtained, which can vary by territory
and product but typically will be on acceptance of application by the relevant regulatory authority, the provision is adjusted
appropriately to increase the carrying value to expected net realisable value, which may not exceed original cost.
Adjustments to the provision for inventories manufactured prior to regulatory approval are recorded as a component of research and
development expenditure. Adjustments to the provision against commercial product related inventories manufactured following
achievement of regulatory approval are recorded as a component of cost of goods.
Taxation
The tax expense represents the sum of the tax currently payable or recoverable and deferred tax. Current and deferred taxes are
recognised in profit or loss, except when they relate to items that are recognised in other comprehensive income or directly in equity, in
which case, the current and deferred tax are also recognised in other comprehensive income or directly in equity, respectively. Where
current or deferred tax arises from the initial accounting for a business combination, the tax effect is included in the accounting for the
business combination.
The tax payable or recoverable is based on taxable profit for the year. Taxable profit differs from profit before tax as reported in the
Consolidated Income Statement because it excludes items of income or expense that are taxable or deductible in other years and it
further excludes items that are never taxable or deductible. The Group’s liability for current tax is calculated using tax rates and laws
that have been enacted or substantively enacted by the balance sheet date.
Deferred tax is the tax expected to be payable or recoverable on differences between carrying amounts of assets and liabilities in the
financial statements and the corresponding tax bases used in the computation of taxable profit, and is accounted for using the balance
sheet liability method. Deferred tax liabilities are generally recognised for all taxable temporary differences and deferred tax assets are
recognised only to the extent that it is probable that taxable profits will be available against which deductible temporary differences
can be utilised. Such assets and liabilities are not recognised if the temporary difference arises from the initial recognition of goodwill
or from the initial recognition (other than in a business combination) of assets and liabilities in a transaction that affects neither the
taxable profit nor the accounting profit.
Deferred tax liabilities are recognised for taxable temporary differences arising on investments in subsidiaries and associates, and
interests in joint ventures, except where the Group is able to control the reversal of the temporary difference and it is probable that the
temporary difference will not reverse in the foreseeable future.
The carrying amount of deferred tax assets is reviewed at each balance sheet date and reduced to the extent that it is no longer
probable that sufficient future taxable profits will be available to allow all or part of the asset to be recovered.
Deferred tax is calculated at the tax rates that are expected to apply in the period when the liability is settled or the asset is realised
based on tax laws and rates that have been enacted or substantively enacted at the balance sheet date. Deferred tax is charged or
credited in the Consolidated Income Statement, except when it relates to items charged or credited in other comprehensive income, in
which case the deferred tax is also dealt with in other comprehensive income.
Deferred tax assets and liabilities are offset when there is a legally enforceable right to set off current tax assets against current tax
liabilities and when they relate to income taxes levied by the same taxation authority and the Group intends to settle its current tax
assets and liabilities on a net basis.
(Loss)/Earnings per Share
Basic earnings or loss per share is calculated by dividing the net profit or loss by the weighted average number of ordinary shares
outstanding for the period, without consideration for ordinary share equivalents. Diluted profit or loss per share is computed by dividing
the net profit or loss by the weighted average number of ordinary shares and ordinary share equivalents outstanding for the period.
For the purposes of this calculation, market-priced share options are considered to be ordinary share equivalents but are not included
in the calculations of diluted net loss per share for the periods presented as their effect would be antidilutive. Nominal exercise-price
options are considered ordinary share equivalents and are included in the calculation of basic weighted average shares outstanding
once they have become vested.
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GW Pharmaceuticals plc | Annual Report and Accounts 2018 2. Significant Accounting Policies continued
The Company incurred net losses for both periods presented and there were no reconciling items for potentially dilutive shares. More
specifically, at 31 December 2018 and 30 September 2017, options totalling approximately 13.0 million ordinary shares and 7.5 million
ordinary shares respectively were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive.
Retirement Benefit Costs
The Group does not operate any pension plans, but makes contributions to personal pension arrangements of its Executive Directors
and employees. The amounts charged to the Consolidated Income Statement in respect of pension costs are the contributions payable
in the year. Differences between contributions payable in the year and contributions paid are shown as either accruals or prepayments
in the Consolidated Balance Sheet.
Foreign Currency
The individual financial statements of each Group company are prepared in the currency of the primary economic environment in
which it operates (its functional currency). For the purpose of the consolidated financial statements, the results and financial position
of the Group is presented in United States Dollars (US$).
The Group additionally reassessed its functional currency and considered that the Group’s parent company, GW Pharmaceuticals plc,
had a functional currency of US Dollars with effect from 1 July 2018.
The functional currencies of some of the Company’s subsidiaries differ from the consolidated group US dollar presentation currency.
As a result, the assets and liabilities of these subsidiaries are translated on consolidation at the rates of exchange prevailing at the
balance sheet date. Revenue and expenses are translated at the average rate of exchange for the period. The unrealised gain or loss
resulting from this translation is recognised in accumulated other comprehensive income.
In preparing the financial statements of the individual companies, transactions in currencies other than the entity’s functional currency
(foreign currencies) are recorded at the rate of exchange at the date of the transaction. Monetary assets and liabilities denominated in
foreign currencies at the balance sheet date are retranslated at the rates of exchange prevailing at that date. Non-monetary items
carried at fair value that are denominated in foreign currencies are translated at the rates prevailing at the date when the fair value was
determined. Non-monetary items that are measured in terms of historical cost in a foreign currency are not retranslated.
For the purpose of presenting consolidated financial statements, the assets and liabilities of the Group’s foreign operations are
translated at exchange rates prevailing on the balance sheet date. Income and expense items are translated at the average exchange rate
for the period, unless exchange rates fluctuate significantly during the period, in which case the exchange rates at the date of
transactions are used. Exchange differences arising, if any, are recognised in other comprehensive income and accumulated in equity.
Share-Based Payments
The Group operates a number of equity-settled share-based compensation plans under which the Company receives services from
employees as consideration for equity instruments (options) of the Company. The fair value of the employee services received in exchange
for the grant of the awards is recognised as an expense. The total amount to be expensed is determined by reference to the fair value of the
options granted (excluding the effect of any non-market-based performance and service vesting conditions) at the date of grant.
The fair value determined at the grant date of the equity-settled share-based payments is expensed on a straight-line basis over the
vesting period, based on the Group’s estimate of shares that will eventually vest. At each balance sheet date, the Group revises its
estimate of the number of equity instruments expected to vest as a result of the effect of non-market-based performance and service
vesting conditions. The impact of the revision of the original estimates, if any, is recognised in profit or loss such that the cumulative
expense reflects the revised estimate, with a corresponding adjustment to equity reserves.
Equity-settled share-based payment transactions with parties other than employees are measured at the fair value of the goods or
services received, except where that fair value cannot be estimated reliably, in which case they are measured at the fair value of the
equity instruments granted, measured at the date of grant.
Leases
Leases are classified as finance leases whenever the terms of the lease transfer substantially all the risks and rewards of ownership to
the lessee. All other leases are classified as operating leases.
Rentals under operating leases are charged on a straight-line basis over the term of the relevant lease except where another more
systematic basis is more representative of the time pattern in which economic benefits from the lease are consumed. Contingent rentals
arising under operating leases are recognised as an expense in the period in which they are incurred.
In the event that lease incentives are received to enter into operating leases, such incentives are recognised as a liability. The aggregate
benefit of incentives is recognised as a reduction of rental expense on a straight-line basis, except where another systematic basis is
more representative of the time pattern in which economic benefits from the leased asset are consumed.
50
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 Assets held under finance leases are recognised as assets of the Group at their fair value or, if lower, the present value of the minimum
lease payments, each determined at the inception of the lease. The corresponding liability to the lessor is included in the balance sheet
as a finance lease obligation. Lease payments are apportioned between finance charges and reduction of the finance lease obligation so
as to achieve a constant rate of interest on the remaining balance of the liability. Finance expenses are recognised immediately in profit
or loss, unless they are directly attributable to qualifying assets, in which case they are capitalised in accordance with the Group’s
general policy on borrowing costs. Contingent rentals are recognised as an expense in the periods in which they are incurred.
Financial Instruments
Financial assets and liabilities are recognised in the Group’s balance sheet when the Group becomes party to the contractual
provisions of the instrument.
All financial assets are recognised and derecognised on a trade date where the purchase or sale of a financial asset is under a contract
whose terms require delivery of the financial asset within the timeframe established by the market concerned, and are initially
measured at fair value, plus transaction costs, except for those financial assets classified as at fair value through profit or loss, which
are initially measured at fair value.
Financial assets are classified into the following specified categories: financial assets “at fair value through profit or loss”, “held-to-
maturity” investments, “available-for-sale” financial assets and “loans and receivables”. The classification depends on the nature and
purpose of the financial assets and is determined at the time of initial recognition.
For each reporting period covered herein, the Group’s financial assets were restricted to “loans and receivables”.
Loans and Receivables
Trade receivables that have fixed or determinable payments that are not quoted in an active market are classified as “loans and
receivables”. Loans and receivables are measured at amortised cost, less any impairment. Interest income is recognised by applying the
effective interest rate, except for short-term receivables when the recognition of interest would be immaterial.
Trade receivables are assessed for indicators of impairment at each balance sheet date. Trade receivables are impaired where there is
objective evidence that, as a result of one or more events that occurred after initial recognition, the estimated future cash flows of the
receivables have been affected. Appropriate allowances for estimated irrecoverable amounts are recognised in the Consolidated Income
Statement. The allowance recognised is measured as the difference between the asset’s carrying amount and the present value of
estimated future cash flows discounted at the effective interest rate computed at initial recognition.
Cash and Cash Equivalents
Cash and cash equivalents comprise cash in hand and on-call deposits held with banks and other short-term highly liquid investments
with a maturity of three months or less.
Financial Liabilities
Financial liabilities are classified as either financial liabilities “at fair value through profit and loss” or “other financial liabilities”. For
each reporting period covered herein, the Group’s financial liabilities were restricted to “other financial liabilities”.
Other Financial Liabilities
Trade payables are initially recognised at fair value and then held at amortised cost which equates to nominal value. Long-term
payables are discounted where the effect is material.
All borrowings are initially recorded at the amount of proceeds received, net of transaction costs. Borrowings are subsequently carried
at amortised cost, using the effective interest method. The difference between the proceeds, net of transaction costs, and the amount
due on redemption is recognised as a charge to the income statement over the period of the relevant borrowing.
The effective interest method is a method of calculating the amortised cost of a financial liability and of allocating interest expense
over the relevant period. The effective interest rate is the rate that exactly discounts estimated future cash payments through the
expected life of the financial liability or, where appropriate, a shorter period, to the net carrying amount on initial recognition.
Critical Judgements in Applying the Group’s Accounting Policies
In the application of the Group’s accounting policies, which are described above, the Board of Directors are required to make
judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other
sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be
relevant. Actual results may differ from these estimates.
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GW Pharmaceuticals plc | Annual Report and Accounts 2018 2. Significant Accounting Policies continued
The estimates and assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognised in the period in
which the estimate is revised if the revision affects only that period, or in the period of the revisions and future periods if the revision
affects both current and future periods.
The following are the critical judgements, apart from those involving estimations (which are dealt with separately below), that the
Directors have made in the process of applying the Group’s accounting policies and that have the most significant effect on the
amounts recognised in the financial statements.
Inventories
Inventories manufactured prior to regulatory approval are capitalised as an asset but provided for until there is a high probability of
regulatory approval of the product.
During the period to 31 December 2018, the Group commenced capitalisation of Epidiolex inventory material and associated
production costs at the point of acceptance of the Group’s NDA filing with FDA in December 2017. At the point of FDA approval in
June 2018, the Group concluded that the remaining doubt of regulatory approval had been removed and the provision was adjusted to
increase the carrying value to expected net realisable value. This adjustment to the provision was recorded as a component of research
and development expenditure.
Any subsequent adjustments to the provision against commercial product related inventories manufactured following achievement of
regulatory approval have been recorded as a component of cost of goods.
Key Sources of Estimation Uncertainty
The key assumptions concerning the future, and other key sources of estimation uncertainty at the balance sheet date, that have a
significant risk of causing a material adjustment to the carrying amounts of assets and liabilities within the next financial year, are
discussed below.
Deferred Taxation
At the balance sheet date, the Group has accumulated tax losses of $515.0 million (30 September 2017: $272.6 million) and other
temporary differences of $21.5 million (30 September 2017: $23.8 million) available to offset against future profits. If the value of these
losses and other temporary differences were recognised within the Group’s balance sheet at the balance sheet date, the Group would
be carrying an additional deferred tax asset of $91.2 million (30 September 2017: $50.4 million). However, as explained in the tax
accounting policy note, the Group’s policy is to recognise deferred tax assets only to the extent that it is probable that future taxable
profits, feasible tax-planning strategies, and deferred tax liabilities will be available against which the brought-forward trading losses
can be utilised. Estimation of the level of future taxable profits is therefore required in order to determine the appropriate carrying
value of the deferred tax asset at each balance sheet date. As such, a deferred tax asset of $8.4 million has been recognised at
31 December 2018 (30 September 2017: $8.2 million) in respect of temporary timings differences relating to the Group’s US subsidiary
that are expected to be fully recoverable.
Impairment of Investments in Subsidiaries and Inter-Company Receivables
The Company considers the recoverability of investments in subsidiaries and inter-Company receivables on an ongoing basis,
whenever indicators of impairment are present. If facts and circumstances indicate that investment in subsidiaries may be impaired,
the estimated future cash flows associated with these subsidiaries would be compared to their carrying amounts to determine if a
write-down to fair value is necessary.
Adoption of New and Revised Standards
In the current period the following revised standards have been adopted in these financial statements. With the exception of the
adoption of IFRS 15, adoption has not had a significant impact on the amounts reported in these financial statements but may impact
the accounting for future transactions.
IFRS 9 Financial Instruments (July 2014)
IFRS 15 Revenue from Contracts with Customers
Amendments to IAS 7: Disclosure Initiative (January 2016)
Amendments to IAS 12: Recognition of Deferred Tax Assets for Unrealised Losses (January 2016)
Amendments to IFRS 10 and IAS 28: Sale or Contribution of Assets between an Investor and its Associate or Joint Venture (September 2014)
52
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 At the date of authorisation of these financial statements, the following Standards and Interpretations which have not been applied in
these financial statements were issued by the IASB but not yet effective:
IFRS 11 Joint Arrangements Annual Improvements to IFRSs 2015–2017 Cycle
IFRS 16 Leases (January 2016)
IFRS 17 Insurance Contracts (May 2017)
Amendments to IFRS 1: Annual Improvements to IFRS Standards 2014–16 (December 2016)
Amendments to IFRS 2: Classification and Measurement of Share-Based Payment Transactions (June 2016)
Amendments to IFRS 3: Annual Improvements to IFRSs 2015–2017 Cycle
Amendments to IFRS 4: Applying IFRS 9 Financial Instruments with IFRS 4 Insurance Contracts (September 2016)
Amendments to IAS 23: Annual Improvements to IFRSs 2015–2017 Cycle
Amendments to IAS 40: Transfer of Investment Property (December 2016)
Amendments to IFRS 9: Prepayment Features with Negative Compensation (October 2017)
Amendments to IAS 28: Annual Improvements to IFRSs 2014–2016 Cycle
Amendments to IAS 28: Long-Term Interests in Associates and Joint Ventures (October 2017)
IFRS 15 Revenue from Contracts with Customers: IFRS 15 establishes a comprehensive framework for determining whether, how
much and when revenue is recognised. It replaced IAS 18 Revenue and its related interpretations. Under IFRS 15, revenue is recognised
when a customer obtains control of the goods or services. Determining the timing of the transfer of control – at a point in time or over
time – requires judgement.
The Group has early-adopted IFRS 15 with practical expedients, with the effect of initially applying this standard recognised at the
date of initial application (i.e. 1 October 2017). Accordingly, the comparative information presented for 2017 has not been restated –
i.e. it is presented, as previously reported, under IAS 18 and related interpretations. Additionally, the disclosure requirements in IFRS
15 have not generally been applied to comparative information.
The following table summarises the impact of transition to IFRS 15 on retained earnings at 1 October 2017.
Retained earnings
Acceleration of deferred signature fee income
Impact at 1 October 2017
Impact of
adopting
IFRS 15 at 1
October
2017
$000s
7,433
7,433
The following tables summarise the impact of adopting IFRS 15 on the Group’s Consolidated Statement of Financial Position as at
31 December 2018 and its Consolidated Income Statement for the period then ended for each of the line items affected. There was no
material impact on the Group’s statement of cash flows for the 15-month period ended 31 December 2018.
Impact on the Consolidated Balance Sheet
Assets
Total Assets
Equity
Accumulated deficit brought forwards
Total Equity
Liabilities
Deferred revenue
Total Liabilities
As reported
$000s
Adjustments
$000s
–
–
–
–
Amounts
without
adoption of
IFRS 15
$000s
–
–
(426,109)
(426,109)
7,433
(433,542)
7,433 (433,542)
–
–
5,613
5,613
5,613
5,613
53
GW Pharmaceuticals plc | Annual Report and Accounts 2018 2. Significant Accounting Policies continued
Impact on the Consolidated Income Statement
Revenue
Product sales
Research and development fees
License, collaboration and technical access fees
Development and approval milestones
Total Revenue
Cost of sales
Research and development expenditure
Sales, general and administrative expenses
Net foreign exchange loss
Operating loss
Interest expense
Interest and other income
Loss before tax
Tax charge
Loss for the period
As reported
$000s
Adjustments
$000s
Amounts
without
adoption of
IFRS 15
$000s
17,085
2,153
–
153
19,391
(7,912)
(167,142)
(187,602)
(2,666)
(345,931)
(1,573)
11,155
–
–
(1,820)
–
(1,820)
–
–
–
–
17,085
2,153
1,820
153
21,211
(7,912)
(167,142)
(187,602)
(2,666)
(1,820) (344,111)
(1,573)
11,155
–
–
(336,349)
(5,090)
(1,820) (334,529)
(5,090)
–
(341,439)
(1,820)
(339,619)
License, collaboration and technical access fees: Under IAS 18, revenue relating to deferred signature fees was recognised in a linear fashion
over the expected timeline of the underlying research and collaboration agreement, based on an estimate formed at inception of the agreement.
Under IFRS 15, recognition of the deferred signature fees is instead linked to the specific R&D performance obligations under the
agreement. Per the requirements of IFRS 15, the completion of these performance obligations occurred at an earlier stage, and so leads
to recognition of the deferred signature fee balances faster than previously accounted for under IAS 18. All performance obligations
with the affected agreements were completed in a prior accounting period according to IFRS 15, and therefore there are no significant
ongoing effects of the adoption of IFRS 15.
IFRS 15 did not have a significant impact on the Group’s accounting policies with respect to other revenue streams, and so no
adjustment was required.
IFRS 16 Leases: The Group is required to adopt IFRS 16 Leases from 1 January 2019. The Group has assessed the estimated impact
that initial application of IFRS 16 will have on its consolidated financial statements, as described below. The actual impacts of
adopting the standard on 1 January 2019 may change because the new accounting policies are subject to change until the Group
presents its first financial statements that include the date of initial application.
IFRS 16 introduces a single, on-balance sheet lease accounting model for lessees. A lessee recognises a right-of-use asset representing
its right to use the underlying asset and a lease liability representing its obligation to make lease payments. There are recognition
exemptions for short-term leases and leases of low-value items. Lessor accounting remains similar to the current standard – i.e. lessors
continue to classify leases as finance or operating leases.
IFRS 16 replaces existing leases guidance, including IAS 17 Leases, IFRIC 4 Determining whether an Arrangement contains a Lease,
SIC-15 Operating Leases – Incentives and SIC-27 Evaluating the Substance of Transactions Involving the Legal Form of a Lease.
The Group will recognise new assets and liabilities for its operating leases of office space, warehouse and production facilities. The
nature of expenses related to those leases will now change because the Group will recognise a depreciation charge for right-of-use
assets and interest expense on lease liabilities.
Previously, the Group recognised operating lease expense on a straight-line basis over the term of the lease, and recognised assets and
liabilities only to the extent that there was a timing difference between actual lease payments and the expense recognised. In addition,
the Group will no longer recognise provisions for operating leases that it assesses to be onerous. Instead, the Group will include the
payments due under the lease in its lease liability. No significant impact is expected for the Group’s finance leases.
54
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 While the Group is still finalising the adoption procedures, the Group estimates that the adoption of this standard will result in
recognition of additional lease assets and lease liabilities on its consolidated balance sheet as of 1 January 2019 of approximately $13.0
million to $17.0 million. The Group does not believe the adoption of IFRS 16 will materially affect its consolidated net loss or liquidity.
The Group plans to apply IFRS 16 initially using the modified retrospective approach. Therefore, the cumulative effect of adopting
IFRS 16 will be recognised as an adjustment to the opening balance of retained earnings at 1 January 2019, with no restatement of
comparative information.
The Group plans to apply the practical expedient to grandfather the definition of a lease on transition. This means that it will apply
IFRS 16 to all contracts entered into before 1 January 2019 and identified as leases in accordance with IAS 17 and IFRIC 4.
The Directors do not expect that the adoption of the remaining Standards and Interpretations in future periods will have a material
impact on the financial statements of the Group.
3. Segmental Information
In accordance with IFRS 8 Operating Segments, the chief operating decision maker (“CODM”), who is responsible for allocating
resources and assessing performance of the Group, has been identified as a sub-group of the Executive Leadership Team (“ELT”),
consisting of those members charged with executive management of the Group’s business activities.
In December 2017, the Group’s research and development agreement with Otsuka was terminated by mutual agreement. As part of
this process, the rights to develop and commercialise Sativex in the United States were returned to the Group. As a result of this, the
recognition of certain advance payments and deferred signature fee income balances in the Income Statement was accelerated on the
basis that no further obligations remain to be fulfilled by the Group. The Group’s CODM considered that, following this termination,
the nature of the Group’s operations has changed such that a review of operating segments was performed. The results of this
identified that reporting a single operating segment has become appropriate, and reflects the Group’s strategy of discovering,
developing and commercialising novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease
areas. The subsequent FDA approval and successful commercial release of another pipeline candidate, Epidiolex, during the last
quarter of the current financial period further confirms this strategic orientation. Accordingly, the information required under IFRS 8
“Operating Segments”, including the respective comparative information, has been presented for the single operating segment below.
The Group has licensing agreements for the commercialisation of Sativex with Almirall S.A. in Europe (excluding the United
Kingdom) and Mexico, Bayer HealthCare AG in the United Kingdom and Canada, Neopharm Group in Israel, Emerge Health Pty. Ltd.
in Australasia and Malaysia and Ipsen Biopharm Ltd. in Latin America (excluding Mexico and the Islands of the Caribbean). Revenues
include product sales, royalties, license, collaboration and technical access fees, and development and approval milestone fees.
Revenues arising from the Group’s activities during the period were as follows:
Revenue
Product sales – Sativex
Product sales – Epidiolex
Product sales – Total
Research and development fees
Licence, collaboration and technical access fees
Development and approval milestones
Segment Results
Revenues from the Group’s largest customers are included within revenue as follows:
Customer A
Customer B
Customer C
Customer D
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
12,416
4,669
17,085
2,153
–
153
19,391
7,957
–
7,957
672
1,750
140
10,519
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
7,937
4,849
3,137
2,065
5,405
–
1,991
669
55
GW Pharmaceuticals plc | Annual Report and Accounts 2018 3. Segmental Information continued
Geographical Analysis of Revenue by Location of Customer:
United Kingdom
Europe (excluding UK)
United States
Canada
Asia/Other
Allocation to geographies is made in reference to the location of each individual customer.
4. Research and Development Expenditure
GW-funded research and development
Development partner-funded research and development
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
1,981
8,012
6,230
1,378
1,790
1,918
6,821
479
743
558
19,391
10,519
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
166,538
604
141,353
669
167,142
142,022
GW-funded research and development expenditure consists of costs associated with the Group’s research activities. These costs
include costs of conducting pre-clinical studies or clinical trials, payroll costs associated with employing a team of research and
development staff, share-based payment expenses, property costs associated with leasing laboratory and office space to accommodate
research teams, costs of growing botanical raw material, costs of consumables used in the conduct of in-house research programmes,
payments for research work conducted by sub-contractors by a network of academic collaborative research scientists, costs associated
with safety studies and costs associated with the development of Epidiolex, Sativex or other pipeline product data.
Development partner-funded research and development expenditures include the costs of maintaining and defending patents. These
expenditures are charged to the Group’s commercial partners, principally Otsuka.
5. Loss Before Tax
Loss before tax is stated after charging/(crediting):
Cost of inventories recognised as an expense
Operating lease rentals – land and buildings
Operating lease rentals – equipment
Depreciation of property, plant and equipment
Impairment of property, plant and equipment
Reversal of impairment of property, plant and equipment
Amortisation of intangible assets
(Increase)/decrease in provision for inventories
Foreign exchange loss
Staff costs (see note 7)
56
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
7,002
6,913
359
10,626
–
–
1,118
893
2,666
147,065
4,521
4,599
32
6,739
809
(276)
313
133
6,442
70,645
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 6. Auditor’s Remuneration
The auditor for the periods ended 31 December 2018 and 30 September 2017 was Deloitte LLP
Audit fees:
– Audit of the Group’s annual accounts1
– Audit of the Company and subsidiaries pursuant to legislation
Total audit fees
Other services
– Audit-related assurance2
– Other assurance services3
– All other services
Total non-audit fees
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
1,908
82
1,990
170
253
68
491
606
74
680
130
26
–
156
1 For the periods ended 31 December 2018 and 30 September 2017, audit fees include amounts for the audit of the consolidated financial statements in accordance with the
International Standards of Auditing, standards of the Public Company Accounting Oversight Board (United States) and include amounts for the audit of the Group’s internal
controls over financial reporting.
2 Audit-related assurance fees relate to fees for the performance of interim reviews, and other procedures on interim results.
3 Other assurance services represents assurance reporting on historical financial information included in the Company’s shelf and follow-on US registration statements.
An additional $79,000 was billed in respect of the 2016 audit during the year ended 30 September 2017.
The Audit Committee’s policy is to pre-approve all audit, audit-related and other services performed by the auditor. All such services were
pre-approved during the period ended 31 December 2018 and year ended 30 September 2017 under the Audit Committee’s policy.
7. Staff Costs
The monthly average number of Group employees for the period was:
Production
Research and development
Sales, general and administration
15 months to
31 December
2018
Number
(Restated)
12 months to
30 September
2017
Number
(Restated)
156
293
234
683
114
319
100
533
During the 15-month period ended 31 December 2018, the Group received FDA approval for Epidiolex in the United States. As a
result, commercial production of Epidiolex commenced during the period. Those employees associated with production activities have
been disclosed separately in the note above for the current period. To aid comparability with the year ended 30 September 2017, those
carrying out comparable activities in the prior year have been reclassified from research and development activities to production.
Employees involved in production activities may produce material used in commercial or research and development activities.
57
GW Pharmaceuticals plc | Annual Report and Accounts 2018 7. Staff Costs continued
The average number of Company employees for the 15-month period was six (year ended 30 September 2017: four), and all in the
current and comparative period are Executive or non-Executive Directors on service agreements.
Group aggregate remuneration comprised:
Wages and salaries
Social security costs
Other pension costs
Share-based payment
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
96,901
6,266
3,378
40,520
47,903
5,492
2,107
15,143
147,065
70,645
The Company incurred $1.4 million of staff costs during the 15-month period ended 31 December 2018 (year ended
30 September 2017: $0.5 million).
8. Directors’ Remuneration
Directors’ remuneration and other benefits for the period ended 31 December 2018 and year ended 30 September 2017 were as follows:
Emoluments
Money purchase contributions to Directors’ pension arrangements
Gain on exercise of share options
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
2,520
10
5,992
8,522
3,997
101
16,570
20,668
During 2018, one Director was a member of a defined contribution pension scheme (year ended 30 September 2017: six).
Further details concerning the Directors’ remuneration, shareholdings and share options which form part of these financial statements
are set out in the Directors’ Remuneration Report on pages 15 to 33.
9. Other income and expense
Interest expense – finance lease interest
Interest expense – fit out funding interest
Total interest expense
Interest income – bank interest
Other income
Total interest and other income
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
(596)
(977)
(1,573)
6,094
5,061
11,155
(461)
(490)
(951)
2,063
–
2,063
Other income relates to an “above the line” credit associated with the UK large company R&D tax scheme. This represents an amount
which was claimable from UK tax authorities in relation to qualifying expenditure incurred in the same period.
58
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018
10. Tax
a) Analysis of Tax Charge/(Benefit) for the Period
Current year research and development tax credit
Current period tax charge
Adjustment in respect of prior year tax credit
Deferred tax credit
Movements on deferred tax assets
Tax charge/(benefit)
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
–
5,134
(55)
–
11
(25,409)
2,738
(598)
(3,349)
166
5,090
(26,452)
Tax credits relate to UK research and development tax credits claimed under the Corporation Tax Act 2009. In the period to
31 December 2018, the Group was no longer eligible to claim research and development tax credits under the SME scheme. Tax
credits are now claimed under the large company RDEC scheme and are recorded as other income in the profit and loss account.
The Group recognises in full the estimated benefit for qualifying current period UK research and development expenditures and
resulting tax credits. Any difference in the credit ultimately received is recorded as an adjustment in respect of prior year.
The Group recognises the likely recoverable estimated benefit for qualifying current year US research and development expenditures
and resulting tax credits. Any difference in the credit ultimately received is recorded as an adjustment in respect of prior year.
At 31 December 2018 the Group had tax losses available for carry forward of approximately $515.0 million (30 September 2017:
$272.6 million). These losses were generated in the UK. Of such carried-forward losses, which are not subject to expiry, the Group has
recognised a deferred tax asset of $1.7 million (30 September 2017: $2.2 million) up to the level of deferred tax liabilities arising in the
same jurisdiction and additionally an asset supportable by taxable income projections of $nil (30 September 2017: $nil). The Group
has also recognised a deferred tax asset of $8.4 million (30 September 2017: $8.4 million) in respect of taxable temporary timing
differences relating to timing differences in another jurisdiction supportable by taxable income projections. In addition, the Group has
not recognised deferred tax assets relating to other temporary differences of $21.5 million (30 September 2017: $23.8 million). These
deferred tax assets have not been recognised as the Group’s management considers that there is insufficient future taxable income,
taxable temporary differences and feasible tax-planning strategies to utilise all of the cumulative losses and therefore it is probable that
the deferred tax assets will not be realised in full. If future income differs from current projections, this could significantly impact the
tax charge or benefit in future periods.
In addition to the amount charged to the income statement and other comprehensive income, the following amounts relating to tax
have been recognised directly in equity:
Change in estimate of excess tax deductions related to share-based payments
Total income tax recognised directly in equity
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
(123)
(123)
171
171
59
GW Pharmaceuticals plc | Annual Report and Accounts 2018 10. Tax continued
b) Factors Affecting the Tax Benefit for the Year
The tax benefit for the period can be reconciled to the tax benefit on the Group’s loss for the period at the standard UK corporation
tax rate as follows:
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
Loss before tax
Tax credit on Group loss before tax at the standard UK corporation tax rate of 19.0%
(Year ended 30 September 2017: 19.5%)
Effects of:
Expenses not deductible in determining taxable profit
Impact of employee share acquisition relief
Current year UK research and development tax credit
Current year US tax credits
R&D enhanced tax relief and surrender of losses
Effect of unrecognised losses and temporary differences
Overseas profits taxed at different rates
Adjustment in respect of prior year tax credit
Tax
(336,349) (194,597)
(63,906)
(37,946)
1,676
(3,093)
–
(2,940)
–
67,412
5,996
(55)
967
(3,565)
(25,409)
(2,574)
14,855
27,234
582
(596)
5,090
(26,452)
The following are the major deferred tax liabilities and assets recognised by the Group and movements thereon during the current and
prior reporting periods:
At 1 October 2016
Credited to profit or loss
Charged to equity
Exchange differences
At 1 October 2017
Credited/(charged) to profit or loss
Credited to equity
Exchange differences
At 31 December 2018
Accelerated
Tax
Depreciation
$000s
(2,477)
137
–
(79)
(2,419)
1,533
–
46
Tax Losses
$000s
2,371
281
–
94
2,746
(1,657)
–
(53)
(840)
1,036
Share-Based
Payment
and Other
Compensation
$000s
5,107
2,931
(171)
197
8,064
113
123
(116)
8,184
Total
$000s
5,001
3,349
(171)
212
8,391
(11)
123
(123)
8,380
Deferred tax assets and liabilities have been offset where the Group has a legally enforceable right to do so, and intends to settle on a
net basis. The taxing authority permits the Group to make or receive a single net payment for all UK subsidiaries. The Group’s US
subsidiary operates in a different jurisdiction with no legally enforceable right to offset against UK tax charges or credits.
On 15 September 2016, the reduction in the main rate of corporation tax from 19% to 17% was enacted, with effect from 1 April 2020.
This reduction to 17% received Royal Assent in February 2019. The enacted UK tax rate until 31 March 2017 was 20%.
60
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 11. Loss Per Share
The calculations of loss per share are based on the following data:
Loss for the period – basic and diluted
Weighted average number of ordinary shares
Less ESOP trust ordinary shares1
Weighted average number of ordinary shares for purposes of basic earnings per share
Effect of potentially dilutive shares arising from share options2
Weighted average number of ordinary shares for purposes of diluted earnings per share
Loss per share – basic
Loss per share – diluted
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
(341,439)
(168,145)
Number of shares
15 months to
31 December
2018
million
12 months to
30 September
2017
million
340.4
–
340.4
–
340.4
303.6
–
303.6
–
303.6
(100.3)c
(100.3)c
(55.4)c
(55.4)c
1 As at 31 December 2018 33,054 ordinary shares were held in the ESOP trust (30 September 2017: 33,054). The effect is less than 0.1 million shares, and consequently these have
not been presented above.
2 The Group incurred a loss in each of the financial periods above. As a result, the inclusion of potentially dilutive share options in the diluted loss per share calculation would have
an anti-dilutive effect on the loss per share for the period. The impact of 13.0 million share options have therefore been excluded from the diluted loss per share calculation for the
period ended 31 December 2018 (year ended 30 September 2017: 7.5 million).
12. Intangible Assets – Goodwill
Group
Cost – as at 1 October
Net book value – as at period end
31 December
2018
$000s
30 September
2017
$000s
6,959
6,959
6,959
6,959
Goodwill arose upon the acquisition of GW Research Limited (formerly G-Pharm Limited) in 2001. For impairment testing purposes,
all goodwill has been allocated to the single reportable segment, as described in Note 3, as a separate cash-generating unit. Goodwill
has an indefinite useful life and is tested annually for impairment or more frequently if there are indications of impairment.
The Group has determined the recoverable amount of the Commercial segment based on a value-in-use calculation. This calculation
uses pre-tax cash flow projections based on financial budgets approved by management covering a two-year period. Cash flows beyond
the two-year period are based upon detailed internal and external third-party analysis of the Group’s product opportunity, of which
Epidiolex is a significant contributor, or are extrapolated using the estimated growth rates stated below. The projections include
assumptions about the timing and likelihood of product launches and pricing policy.
Management has determined the following assumptions to be the key assumptions in the calculation of value-in-use for the
Commercial segment:
Growth rate – sales volume in each period is the main driver for revenue and costs. The same growth rates have been used in financial
budgets and are consistent with in-market run rates and internal commercial forecasts based on a 10-year period.
Long-term growth rate – A 0% growth rate has been applied after 10 years (30 September 2017: 0% after 10 years). This approach has
been adopted by management as it is representative of the long development and product lifecycle in the pharmaceutical sector. In
future periods, depending on the performance of the Commercial segment, it may be necessary to revise the terminal growth rate.
Discount rate – a 13.4% (30 September 2017: 15.7%) pre-tax rate has been used. This is considered appropriate for the purpose of
impairment reviews as it reflects the current market assessment of the time value of money and the risks specific to the cash-generating unit.
Any reasonably possible change in the key assumptions on which value-in-use is based would not cause the carrying amount to exceed
the recoverable amount of the Commercial segment.
61
GW Pharmaceuticals plc | Annual Report and Accounts 2018 13. Other Intangible Assets
Group
Cost
At 1 October 2016
Additions
Reclassifications
Transfers of completed assets
Disposals
Exchange differences
At 1 October 2017
Additions
Transfers of completed assets
Disposals
Exchange differences
At 31 December 2018
Accumulated amortisation
At 1 October 2016
Charge for the year
Exchange differences
At 1 October 2017
Charge for the period
Disposals
Exchange differences
At 31 December 2018
Net book value
At 31 December 2018
At 30 September 2017
Software
$000s
Licences
$000s
Total
$000s
Intangible
Assets Under
the Course of
Construction
$000s
535
323
52
(697)
(52)
10
171
2,398
(2,508)
–
8
69
–
–
–
–
–
–
–
–
379
459
–
697
–
66
1,601
–
2,508
(165)
(181)
3,763
197
297
22
516
1,078
(4)
(76)
1,514
69
171
2,249
1,085
107
61
–
–
–
6
174
–
–
–
(9)
165
12
16
1
29
40
–
(3)
66
99
145
1,021
843
52
–
(52)
82
1,946
2,398
–
(165)
(182)
3,997
209
313
23
545
1,118
(4)
(79)
1,580
2,417
1,401
Included in additions are $nil of other intangible assets which are unpaid at the balance sheet date and are included in trade and other
payables (30 September 2017: $nil).
62
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 14. Property, Plant and Equipment
Group
Cost
At 1 October 2016
Additions
Reclassifications
Transfers of completed assets
Transfers to assets held for sale in year
Disposals
Exchange differences
At 1 October 2017
Additions
Transfers of completed assets
Disposals
Exchange differences
At 31 December 2018
Accumulated depreciation and impairment
At 1 October 2016
Charge for the year
Transfers to assets held for sale in year
Impairment of assets
Reversal of impairment of assets
Disposals
Exchange differences
At 1 October 2017
Charge for the period
Disposals
Exchange differences
At 31 December 2018
Net book value
At 31 December 2018
At 30 September 2017
Assets Under
the Course of
Construction
$000s
Leasehold
Buildings
$000s
27,578
13,990
(52)
(33,921)
–
(498)
183
7,280
45,743
(7,991)
–
(2,133)
4,652
–
–
–
–
–
160
4,812
–
–
–
(239)
Plant,
Machinery
and Lab
Equipment
$000s
16,566
599
–
12,697
(1,595)
(984)
1,067
28,350
163
6,002
(228)
(1,676)
Office and IT
Equipment
$000s
Leasehold
Improvements
$000s
1,831
92
–
168
–
(42)
65
2,114
232
569
(283)
(111)
13,304
535
–
21,056
–
(287)
1,435
36,043
314
1,420
–
(1,824)
Total
$000s
63,931
15,216
(52)
–
(1,595)
(1,811)
2,910
78,599
46,452
–
(511)
(5,983)
42,899
4,573
32,611
2,521
35,953
118,557
783
–
–
–
(276)
(498)
(9)
–
–
–
–
–
81
230
–
–
–
–
13
324
299
–
(30)
593
7,132
2,765
(435)
809
–
(215)
381
10,437
4,351
(78)
(712)
869
423
–
–
–
(41)
46
1,297
578
(233)
(73)
4,775
3,321
–
–
–
(191)
308
8,213
5,398
–
(644)
13,640
6,739
(435)
809
(276)
(945)
739
20,271
10,626
(311)
(1,459)
13,998
1,569
12,967
29,127
42,899
7,280
3,980
4,488
18,613
17,913
952
817
22,986
89,430
27,830
58,328
The Company does not own any property, plant and equipment.
The net book value of property, plant and equipment at 31 December 2018 includes $5.1 million in respect of assets held under finance
leases (30 September 2017: $6.1 million). Included in additions is $0.1 million of property, plant and equipment which is unpaid and is
included in trade and other payables (30 September 2017: $2.7 million).
During the prior financial year, the Group’s purpose-built manufacturing and processing facility was completed and occupied. Upon
completion the associated capitalised costs previously held in Assets Under the Course of Construction were reclassified to the
relevant asset class for each component asset. Depreciation commenced at this date and will continue over the relevant assets’ useful
economic lives.
63
GW Pharmaceuticals plc | Annual Report and Accounts 2018 15. Inventories
Group
Raw materials
Work in progress
Finished goods
Total inventories, net of provision
31 December
2018
$000s
30 September
2017
$000s
724
41,918
8,365
51,007
266
4,513
890
5,669
Inventories with a carrying value of $35.3 million are considered to be recoverable after more than one year from the balance sheet
date, but within the Group’s normal operating cycle (30 September 2017: $2.8 million).
The provision for inventories relates to inventories expected to be utilised in the Group’s R&D activities. The movement in the
provision for inventories is as follows:
Opening balance
Write-down of inventories
Write off of inventories included in the provision
Reversal of write-down of inventories
Foreign exchange
Closing balance
31 December
2018
$000s
30 September
2017
$000s
55
24,359
(467)
(22,954)
(45)
948
152
203
(226)
(75)
1
55
The reversal of write-down is as a result of the Group achieving a successful Federal Drug Administration (FDA) approval for
Epidiolex in the United States in June 2018. This reduced the uncertainty surrounding the recoverability of existing commercial
inventory, and therefore resulted in the reversal of the provision on Epidiolex-related inventory accumulated prior to that date.
Write off of inventories previously provided for and reversal of write-down of inventory does not impact cash flow.
The Company did not own any inventory in the current or prior years.
64
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 16. Trade and Other Receivables
Amounts falling due within one year
Trade receivables
Prepayments and accrued income
Other receivables
Amounts due from group undertakings
Group
Company
31 December
2018
$000s
30 September
2017
$000s
31 December
2018
$000s
30 September
2017
$000s
4,192
10,967
4,265
–
19,424
1,366
9,993
3,624
–
–
1,768
2
182,106
14,983
183,876
–
377
71
60,754
61,202
Trade receivables disclosed above are classified as loans and receivables and are therefore measured at amortised cost.
Trade receivables at 31 December 2018 represent 105 days of sales (30 September 2017: 45 days). The average trade receivable days during the
period ended 31 December 2018 was 45 days (year ended 30 September 2017: 47 days). The credit period extended to customers is 30 to 60 days.
The trade receivables balance at 31 December 2018 consisted of balances due from six customers (30 September 2017: five customers) with
the largest single customer representing 87% (30 September 2017: 53%) of the total amount due. The Group’s customers consist of a small
number of large pharmaceutical companies, where the risk attributable to each customer is considered to be low. The Group seeks to mitigate
credit risk by seeking payments in advance from pharmaceutical partners for significant expenditure to be incurred on their behalf.
No interest is charged on trade receivables. No impairment losses were recognised during the period ended 31 December 2018 (year ended
30 September 2017: $nil).
Prepayments and accrued income include $1.6 million (30 September 2017: $5.1 million) of deposits paid in advance on tangible and
intangible fixed assets. The goods and services associated with these deposits are expected to be received by the Group within one year.
The Directors consider that the carrying value of trade receivables approximates to their fair value due to the short maturity thereof.
17. Trade and Other Payables
Amounts falling due within one year
Other creditors and accruals
Clinical trial and associated accruals
Trade payables
Other taxation and social security
Fit out funding (see note 18)
Onerous lease provision
Amounts owed to group undertakings
Amounts falling due after one year
Fit out funding (see note 18)
Other creditors and accruals
Onerous lease provision
Group
Company
31 December
2018
$000s
30 September
2017
$000s
31 December
2018
$000s
30 September
2017
$000s
41,824
10,059
9,788
1,372
539
4
–
25,824
7,373
7,757
2,714
520
48
–
63,586
44,236
9,434
495
–
9,929
73,515
10,629
1,720
15
12,364
56,600
2,586
–
–
19
–
–
1,960
4,565
–
–
–
–
583
–
285
13
–
–
271
1,152
–
–
–
–
4,565
1,152
65
GW Pharmaceuticals plc | Annual Report and Accounts 2018 17. Trade and Other Payables continued
Trade payables principally comprise amounts outstanding for trade purchases and ongoing costs. Trade payables at 31 December 2018
represent the equivalent of 17 days’ purchases (30 September 2017: 19 days).
The average credit period taken for trade purchases during the period ended 31 December 2018 was 19 days (year ended 30 September
2017: 15 days).
For most suppliers, no interest is charged on invoices that are paid within a pre-agreed trade credit period. The Group has procedures
in place to ensure that invoices are paid within agreed credit terms so as to ensure that interest charges by suppliers are minimised.
The Directors consider that the carrying value of trade payables approximates to their fair value due to the short maturity thereof.
The onerous lease provision relates to an operating lease held on a property which was vacated in order to occupy larger premises.
18. Fit Out Funding
On 19 November 2013 the Group entered into an agreement with its landlord to receive fit out funding of $13.1 million to fund the
expansion and upgrades to manufacturing facilities. The funds were received in tranches, with the final amount received on 1 July
2014. The repayment of the borrowing takes the form of quarterly rental payments over a period of 15 years which commenced on
27 May 2016 when the Group entered into the associated lease of the building. As at 31 December 2018 associated interest of $3.7
million has been incurred (30 September 2017: $3.0 million). The total liability at 31 December 2018 is $10.0 million (30 September
2017: $11.1 million). The Group has estimated that $0.5 million of the total liability will be due within one year and the remaining
$9.4 million is due after one year.
The liability in respect of the funding was initially recognised at the amount of proceeds received, net of transaction costs, and has
been subsequently carried at amortised cost using the effective interest method and a rate of 7.0% (30 September 2017: 7.0%).
The following table details the Group’s remaining contractual maturity for its borrowings and the related interest payments. The tables
are based on the undiscounted cash flows of financial liabilities based on the earliest date on which the Group could be required to
pay. The table includes cash flows for both interest, based on the rate applicable as at 31 December 2018, and principal amounts:
Forward projection of cash flows as at 31 December 2018
Principal
Interest
Total
Forward projection of cash flows as at 30 September 2017
Principal
Interest
Total
<1 year
$000s
1–2 years
$000s
2–3 years
$000s
3–4 years
$000s
4–5 years
$000s
539
686
576
649
619
606
664
561
712
513
1,225
1,225
1,225
1,225
1,225
<1 year
$000s
1–2 years
$000s
2–3 years
$000s
3–4 years
$000s
4–5 years
$000s
520
769
557
732
596
693
641
648
687
602
5+ years
$000s
6,863
1,924
8,787
5+ years
$000s
8,148
2,709
1,289
1,289
1,289
1,289
1,289
10,857
Total
$000s
9,973
4,939
14,912
Total
$000s
11,149
6,153
17,302
66
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 19. Obligations Under Finance Leases
Group
Amounts payable under finance leases:
Within one year
In the second to fifth years inclusive
After five years
Less: future finance charges
Present value of lease obligations
Amounts payable under finance leases:
Amounts due for settlement within 12 months
Amounts due for settlement after 12 months
Minimum Lease Payments
31 December
2018
$000s
30 September
2017
$000s
826
2,804
6,696
743
2,965
7,960
10,326
11,668
(4,236)
(5,042)
6,090
6,626
Present Value of
Lease Payments
31 December
2018
$000s
30 September
2017
$000s
400
5,690
6,090
274
6,352
6,626
It is the Group’s policy to lease certain of its property, plant and equipment under finance leases. The weighted average lease term
remaining is 15.2 years (30 September 2017: 16.1 years). For the period ended 31 December 2018, the average effective borrowing rate
was 7.7% (30 September 2017: 7.6%). Interest rates are fixed at the contract date. All leases to date have been on a fixed repayment
basis and no arrangements have been entered into for contingent rental payments.
All lease obligations are denominated in Pounds Sterling.
The carrying value of the Group’s lease obligations as at 31 December 2018 approximates to their fair value.
The Group’s obligations under finance leases are generally secured by the lessors’ rights over the leased assets.
67
GW Pharmaceuticals plc | Annual Report and Accounts 2018 20. Deferred Revenue
Group
Amounts falling due within one year
Deferred licence, collaboration and technical access fee income
Advance research and development fees
Amounts falling due after one year
Deferred licence, collaboration and technical access fee income
31 December
2018
$000s
30 September
2017
$000s
–
–
–
–
1,558
1,524
3,082
5,690
In the 15-month period to 31 December 2018, the Group adopted IFRS 15 Revenue from Contracts with Customers. More information is
provided in Note 2.
21. Financial Instruments
The capital structure of the Group consists of cash and cash equivalents and total equity attributable to the owners of the parent. The
Group manages its capital to ensure that entities in the Group will be able to continue operating as a going concern while maximising
shareholder returns. The Group’s overall strategy remains unchanged.
Group senior management are responsible for monitoring and managing the financial risks relating to the operations of the Group,
which include credit risk, market risks arising from interest rate risk and currency risk, and liquidity risk. The Board of Directors and
the Audit Committee review and approve the internal policies for managing each of these risks, as summarised below. The Group is
not subject to any externally imposed capital requirements.
The Group’s financial instruments are summarised below:
Categories of Financial Instruments
Financial assets – loans and receivables
Cash at bank and in hand
Cash equivalents – Money market liquidity fund
Cash and cash equivalents
Trade receivables – at amortised cost
Other receivables
Amounts due from group undertakings
Total financial assets
Financial liabilities – amortised cost
Other creditors and accruals
Clinical trial accruals
Trade payables
Fit out funding
Obligations under finance leases
Amounts owed to group undertakings
Total financial liabilities
Group
Company
31 December
2018
$000s
30 September
2017
$000s
31 December
2018
$000s
30 September
2017
$000s
489,869
101,628
591,497
4,192
2,917
–
322,154
–
322,154
1,366
2,269
–
442,568
101,628
544,196
–
950
182,106
257,538
–
257,538
–
187
60,754
598,606
325,789
727,252
318,479
41,212
10,059
9,788
9,973
6,090
–
77,122
22,102
7,373
7,757
11,149
6,626
–
55,007
2,586
–
–
–
–
1,960
4,546
583
–
285
–
–
271
1,139
All Group and Company financial assets are current in nature. All Group financial liabilities, other than the non-current element of
$5.7 million in respect of the obligations under finance leases (30 September 2017: $6.4 million), $0.5 million (30 September 2017: $1.7
million) of other creditors and accruals and $9.4 million (30 September 2017: $10.6 million) of fit out funding received from the
Group’s landlord, are current in nature. All Company financial liabilities were current in nature. In all instances, the Directors
consider that the carrying value of financial assets and financial liabilities approximates to their fair value.
The money market liquidity fund portfolios, accounted for as cash equivalents, are managed by external third-party fund managers to
maintain a AAA rating. The Group’s investments represent no more than 10% of each overall fund value.
68
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 It is, and has been throughout the period ended 31 December 2018 and year ended 30 September 2017, the Group’s policy that no
speculative trading in financial instruments shall be undertaken.
Credit Risk
Credit risk refers to the risk that a counterparty will default on its contractual obligations resulting in financial loss to the Group. The Group
has a policy of only dealing with creditworthy counterparties, principally involving the major UK clearing banks and their wholly owned
subsidiaries, when placing cash on deposit. In addition the Group operates a treasury policy that dictates the maximum cash balance that
may be placed on deposit with any single institution or group. This policy is reviewed and approved by the Board of Directors.
Trade receivables represent amounts due from customers for the sale of commercial product and research funding from development
partners, consisting primarily of a small number of major pharmaceutical companies where the credit risk is considered to be low.
At the balance sheet date, the maximum credit risk attributable to any individual counterparty was $173.4 million (30 September
2017: $114.2 million).
The carrying amount of the financial assets recorded in the financial statements represents the Group’s maximum exposure to credit
risk as no collateral or other credit enhancements are held.
Market Risk
The Group’s activities expose it primarily to financial risks of changes in interest rates and foreign currency exchange rates. These
risks are managed by maintaining an appropriate mix of cash deposits in various currencies, placed with a variety of financial
institutions for varying periods according to the Group’s expected liquidity requirements. There has been no material change to the
Group’s exposure to market risks or the manner in which it manages and measures risk.
i) Interest Rate Risk
The Group is exposed to interest rate risk as it places surplus cash funds on deposit to earn interest income. The Group seeks to ensure
that it secures the best commercially available interest rates from those banks that meet the Group’s stringent counterparty credit
rating criteria. In doing so, the Group manages the term of cash deposits, up to a maximum of 90 days, in order to maximise interest
earnings while also ensuring that it maintains sufficient readily available cash in order to meet short-term liquidity needs.
Interest income of $6.1 million (year ended 30 September 2017: $2.1 million) during the period ended 31 December 2018 was earned
from deposits with a weighted average interest rate of 1.59% (year ended 30 September 2017: 0.89%). Therefore a 100 basis point
increase in interest rates, a reasonable approximation of possible changes in the current economic environment, would have increased
interest income, and reduced the loss for the period, by $3.9 million (year ended 30 September 2017: reduced loss by $2.4 million).
The Group does not have any balance sheet exposure to assets or liabilities which would increase or decrease in fair value with
changes to interest rates.
ii) Currency Risk
The functional currency of the Company, and its subsidiary Greenwich Biosciences, Inc., is US Dollars (“US$”). The functional
currency of each its subsidiaries apart from Greenwich Biosciences, Inc., is Pounds Sterling (“GBP”). The Group receives revenues and
incurs expenditures in foreign currencies and is exposed to the risks of foreign exchange rate movements, with the impact recognised
in the consolidated income statement. The Group seeks to minimise this exposure by passively maintaining foreign currency cash
balances at levels appropriate to meet foreseeable foreign currency expenditures, converting surplus foreign currency balances into
Pounds as soon as they arise. The Group does not use derivative contracts to manage exchange rate exposure.
69
GW Pharmaceuticals plc | Annual Report and Accounts 2018 21. Financial Instruments continued
The table below shows analysis of the US dollar equivalent of period-end cash and cash equivalent balances by currency:
Cash at bank and in hand:
Pounds Sterling
Euro
US Dollar
Australian Dollar
Canadian Dollar
Total
Short-term deposits and cash equivalents (less than 30 days):
US Dollar
Total cash and cash equivalents
Group
Company
31 December
2018
$000s
30 September
2017
$000s
31 December
2018
$000s
30 September
2017
$000s
43,698
4,791
116,839
44
2,493
76,468
2,469
34,304
–
1,338
34,979
–
85,585
–
–
167,865
114,579
120,564
44,556
–
5,406
–
–
49,962
423,632
207,575
423,632
207,576
591,497
322,154
544,196
257,538
The table below shows those transactional exposures that give rise to net currency gains and losses recognised in the consolidated
income statement. Such exposures comprise the net monetary assets and monetary liabilities of the Group that are not denominated in
the functional currency of the relevant Group entity. As at period end these exposures were as follows:
Net Foreign Currency Assets/(Liabilities)
Pounds Sterling
Euro
Canadian Dollar
Other
Group
Company
31 December
2018
$000s
30 September
2017
$000s
31 December
2018
$000s
30 September
2017
$000s
20,386
1,889
2,493
(705)
57,442
561
1,338
(369)
214,292
–
–
–
104,774
–
–
–
24,063
58,972
214,292
104,774
Foreign Currency Sensitivity Analysis
The most significant currencies in which the Group transacts, other than Pounds Sterling, are the US Dollar, the Euro and the
Canadian Dollar. The Group also trades in other currencies in small amounts as necessary.
The following table details the Group’s sensitivity to a 10% change in the period-end rate, which the Group feels is the maximum
likely change in rate based upon recent currency movements, in the key foreign currency exchange rates against Pounds Sterling:
Fifteen-month period ended 31 December 2018
Loss before tax
Equity
Year ended 30 September 2017
Loss before tax
Equity
Pounds
Sterling
$000s
2,039
2,039
Pounds
Sterling
$000s
5,744
5,744
Euro
$000s
189
189
Euro
$000s
56
56
Canadian
Dollar
$000s
249
249
Canadian
Dollar
$000s
134
134
Other
$000s
(70)
(70)
Other
$000s
(37)
(37)
In management’s opinion, the sensitivity analysis is unrepresentative of the inherent foreign exchange risk as the period-end exposure
does not reflect the exposure during the period.
70
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 Liquidity Risk
Responsibility for liquidity risk management rests with the Board of Directors, which has built a liquidity risk management framework
to enable the monitoring and management of short, medium and long-term cash requirements of the business.
The Board of Directors actively monitors Group cash flows and regularly reviews projections of future cash requirements to ensure
that appropriate levels of liquidity are maintained. The Group manages its short-term liquidity primarily by planning the maturity
dates of cash deposits in order to time the availability of funds as liabilities fall due for payment. The Group does not maintain any
borrowing facilities.
Cash deposits, classified as cash and cash equivalents on the balance sheet, comprise deposits placed on money markets for periods of up
to three months and on call. The weighted average time for which the rate was fixed was 32 days (year ended 30 September 2017: 32 days).
All of the Group’s financial liabilities at each balance sheet date have maturity dates of less than 12 months from the balance sheet
date, other than the $5.7 million in respect of the obligations under finance leases (30 September 2017: $6.4 million) and $9.4 million
(30 September 2017: $10.6 million) of fit out funding received from the Group’s landlord. The obligations under finance leases will be
repaid over a weighted average 15.2 year term (30 September 2017: 16.1 year term) and the fit out funding received is being repaid over
a 15-year finance term of which repayments commenced during the year ended 30 September 2016. There have been no material
changes to the Group’s exposure to liquidity risks or the manner in which it manages and measures liquidity risk.
22. Share Capital
As at 31 December 2018 the share capital of the Company’s allotted, called-up and fully paid amounts were as follows:
Allotted, called-up and fully paid
Changes to the number of ordinary shares in issue have been as follows:
As at 1 October 2016
Exercise of share options
As at 1 October 2017
Issue of new shares (net of issuance costs)
Exercise of share options
As at 31 December 2018
31 December
2018
$000s
30 September
2017
$000s
564
483
Number
of
Shares
Total
Nominal
Value
$000s
302,093,139
2,346,601
304,439,740
59,340,000
2,836,948
480
3
483
79
2
Total Share
Premium
$000s
Total
Consideration
$000s
837,374
119
837,493
622,493
616
837,854
122
837,976
622,572
618
366,616,688
564 1,460,602 1,461,166
In December 2017, the Group completed the first equity financing held during the period, issuing 33,120,000 ordinary shares in the
form of American Depositary Shares (“ADSs”) listed on the NASDAQ Global market, raising net proceeds after expenses of US$297.9
million. This took the form of 2,760,000 ADSs at a price to the public of US$115.00 per ADS. Each ADS represents 12 ordinary shares
of 0.1p each in the capital of the Company.
Subsequently, in October 2018 the Group completed its second equity financing during the period, issuing 26,220,000 ordinary shares
in the form of ADSs listed on the NASDAQ Global market, raising net proceeds after expenses of US$324.6 million. This took the
form of 2,185,000 ADSs at a price to the public of US$158.00 per ADS. Each ADS represents 12 ordinary shares of 0.1p each in the
capital of the Company.
The Company has one class of ordinary shares which carry no right to fixed income.
71
GW Pharmaceuticals plc | Annual Report and Accounts 2018 23. Share-Based Payments
Share Option Schemes
In March 2008, the Group adopted the GW Pharmaceuticals plc Long-Term Incentive Plan (“the 2008 LTIP Plan”). Share-based awards
granted by the Group from March 2008 to March 2017 were granted under the 2008 LTIP Plan. On 14 March 2017, the Group adopted
the GW Pharmaceuticals plc 2017 Long-Term Incentive Plan (“the 2017 LTIP Plan”). The 2017 LTIP plan authorises the Group to issue up
to an aggregate of 15,000,000 ordinary shares, or 1,250,000 ADSs, related to share-based awards to employees, non-employee Directors
and consultants. No grants under the 2017 LTIP Plan may be made after 13 March 2022. As of 31 December 2018, 6,706,971 ordinary
shares have been or may be issued pursuant to share-based awards that have been granted under the 2017 LTIP Plan.
The Group issues new ordinary shares and the commensurate number of ADSs when share-based awards are exercised.
Provisions of Share-Based Awards
The Group issues nominal exercise price share options, which have an exercise price equal to the £0.001 par value per ordinary share
of the Company’s ordinary shares, to executive officers, employees and consultants. The Group also issues market-priced options to
executive officers and non-employee Directors. Nominal exercise priced options granted to US residents prior to April 2017 contain
short-term expiration provisions so the awards are compliant with provisions of IRS Code 409(a). Nominal exercise price options
granted to US residents beginning in April 2017 are awarded in the form of RSU-style options.
Substantially all of the share-based awards issued by the Group have service-based vesting conditions. Many awards also have
non-market-based performance conditions, which must be achieved within the service-based vesting period for the awards to vest.
These performance conditions are generally linked to operational, regulatory or strategic milestones and are designed to incentivise
individual employees and advance the Group’s progress towards its strategic objectives. Share-based awards that do not automatically
exercise at vest date expire ten years from the date of grant.
Share-Based Award Activity
The following tables summarise the Group’s share option activity. The number of options, the weighted average grant date fair value
per share option, and the weighted average exercise price are all on a per ordinary share basis. The Group’s ADSs that are listed on the
Nasdaq Global Market each represent 12 ordinary shares.
The following table summarises the Group’s nominal exercise price share option activity:
15 months to
31 December 2018
Nominal
Exercise
Price
Options
Number
Weighted
Average
Grant Date
Fair Value
$
Year ended
30 September 2017
Nominal
Exercise
Price
Options
Number
Weighted
Average
Grant Date
Fair Value
$
9,752,126
4,431,675
(2,767,274)
(234,273)
11,182,254
1,053,777
7.90
9.35
7.22
9.07
8.44
3.65
9,182,071
3,097,105
(2,239,063)
(287,987)
9,752,126
1,986,029
5.16
9.66
3.21
6.69
7.90
4.52
Outstanding, beginning of period
Granted during the period
Exercised during the period
Lapsed during the period
Outstanding, end of period
Exercisable, end of period
72
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 The following table summarises the Group’s market-priced share option activity:
Outstanding, beginning of period
Granted during the period
Exercised during the period
Lapsed during the period
Outstanding, end of period
Exercisable, end of period
15 months to
31 December 2018
12 months to
30 September 2017
Nominal
Exercise
Price
Options
Number
Weighted Average
Grant Date
Fair Value
$
Nominal Exercise
Price
Options
Number
Weighted
Average
Grant Date
Fair Value
$
2,173,822
784,721
(69,673)
–
2,888,870
461,317
8.28
9.65
9.03
–
8.49
6.90
1,451,101
830,263
(107,538)
(4)
2,173,822
–
5.80
9.62
1.15
0.69
8.28
–
The weighted average per share fair value of market-priced options granted during the 15-month period ended 31 December 2018 was
$5.98 (year ended 30 September 2017: $6.00).
The aggregate intrinsic value of the share options exercised in the 15 months ended 31 December 2018 was $32.3 million. The
aggregate intrinsic value of share options exercised in the year ended 30 September 2017 was $22.9 million. As of 31 December 2018,
the weighted average remaining contractual life of options outstanding and options exercisable are 5.1 years and 5.4 years,
respectively. Based on the Group’s closing year-end share price of $97.39 per ADS (or $8.12 per ordinary share) at 31 December 2018,
the aggregate intrinsic value of options outstanding and options exercisable are $97.8 million and $9.8 million, respectively.
Valuation and Expense Recognition of Share-Based Awards
The fair value of share option awards that do not contain a market condition is estimated using the Black-Scholes option-pricing model.
The estimated fair value of each share option is then expensed over the requisite service period, which is generally the vesting period. The
determination of fair value using the Black-Scholes model is affected by the Company’s ADS price as well as assumptions regarding a
number of complex and subjective variables, including expected ADS price volatility, risk-free interest rate, expected dividends and
projected employee share option exercise behaviours. Share options granted during the period ended 31 December 2018 and the year
ended 30 September 2017 were valued using the Black-Scholes option-pricing model with the following weighted-average assumptions:
15 months to
31 December
2018
12 months to
30 September
2017
Weighted average share price
Weighted average exercise price
Expected volatility
Expected life
Risk-free rate
Expected dividend yield
$10.15
$1.58
62%
$9.36
$1.93
67%
3.7 years 3.3 years
1.25%
Nil
2.35%
Nil
The Group estimates its share price volatility based using a combination of historical share price volatility and the average implied
volatility of options traded in the open market. The risk-free interest rate assumption is based on observed interest rates for the
appropriate term of the Group’s share options. The Group has never declared or paid dividends and has no plans to do so in the
foreseeable future. The expected option life assumption is estimated based on the mid-point between vest date and expiration date
since the Group does not have sufficient exercise history to estimate expected option life of historical grants.
Compensation expense for share-based awards based on a service condition is recognised only for those awards that are ultimately
expected to vest. An estimated forfeiture rate has been applied to unvested awards for the purpose of calculating compensation cost.
Forfeitures were estimated based on historical experience. These estimates are revised, if necessary, in future periods if actual
forfeitures differ from the estimates. Changes in forfeiture estimates impact compensation cost in the period in which the change in
estimate occurs. Compensation expense for share-based awards with graded, service-based vesting conditions is recognised over the
requisite service period using the accelerated attribution method.
73
GW Pharmaceuticals plc | Annual Report and Accounts 2018 23. Share-Based Payments continued
The table below summarises the total share-based compensation expense included in the Group’s Consolidated Income Statement for
the periods presented (in thousands):
Cost of sales
Research and development expenditure
Sales, general and administrative expenses
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
413
11,434
28,673
40,520
–
5,164
9,979
15,143
As of 31 December 2018, total compensation cost related to non-vested share options not yet recognised was approximately $39.7 million,
which is expected to be recognised over the next 38 months (11 months on a weighted average basis).
24. Other Reserves
The merger reserve credit of $31.1 million (30 September 2017: credit $31.1 million) was created as a result of the acquisition by the
Company of the entire issued share capital of GW Pharma Limited in 2001. This acquisition was effected by a share-for-share exchange
which was merger accounted under UK Generally Accepted Accounting Practice (“UK GAAP”), in accordance with the merger relief
provisions of Section 131 of the Companies Act 1985 (as amended) relating to the accounting for business combinations involving the
issue of shares at a premium. In preparing consolidated financial statements, the amount by which the fair value of the shares issued
exceeded their nominal value was recorded in a merger reserve on consolidation, rather than in a share premium account. The merger
reserve was retained upon transition to IFRSs, as allowed under UK law. This reserve is not considered to be distributable.
The foreign exchange reserve debit of $80.6 million (30 September 2017: $71.4 million) is due to accumulated foreign exchange
translation differences arising on translation of the group’s operations into a US Dollar presentational currency. This reserve is not
considered to be distributable.
ESOP Reserve
The Group’s “ESOP” is an Inland Revenue-approved all-employee share scheme constituted under a trust deed. The trust holds shares
in the Company for the benefit of and as an incentive for the employees of the Group. The trustee of the ESOP is GWP Trustee
Company Limited, a wholly owned subsidiary of the Company. Costs incurred by the trust are expensed in the Group’s financial
statements as incurred. Distributions from the trust are made in accordance with the scheme rules and on the recommendation of the
Board of Directors of the Company.
Shares held in trust represent issued and fully paid up 0.1p ordinary shares and remain eligible to receive dividends. The shares held by
the ESOP were originally acquired in 2000 for nil consideration by way of a gift from a shareholder and hence the balance on the ESOP
reserve is nil (30 September 2017: nil).
As at the balance sheet date, the ESOP held the following shares:
Unconditionally vested in employees
Shares available for future distribution to employees
Total
31 December
2018
Number
30 September
2017
Number
47,118
33,054
69,119
33,054
80,172
102,173
The valuation methodology used to compute the share-based payment charge related to the ESOP is based on fair value at the grant
date, which is determined by the application of a Black-Scholes share option pricing model. The assumptions underlying the Black-
Scholes model for the ESOP shares are as detailed in note 23 relating to the LTIP awards. The exercise price for shares granted under
the ESOP is nil, and the vesting conditions include employment by the Group over a three-year vesting period from the date of grant.
The share-based payment charge for shares granted under the ESOP plan amounted to $nil in the period ended 31 December 2018
(year ended 30 September 2017: $nil).
As at 31 December 2018 the number and market value of shares held by the trust which have not yet unconditionally vested in
employees is 33,054 (30 September 2017: 33,054) and $0.3 million (30 September 2017: $0.2 million) respectively.
74
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 25. Financial Commitments
The Group had capital commitments for property, plant and equipment contracted but not provided for at 31 December 2018 of
$38.2 million (30 September 2017: $10.2 million).
At the balance sheet date the Group had outstanding commitments for future minimum lease payments under non-cancellable
operating leases, which fall due as follows:
Within one year
Between two and five years
After five years
Group
31 December
2018
$000s
30 September
2017
$000s
6,164
18,673
11,012
35,849
4,846
11,681
2,587
19,114
The minimum lease payments payable under operating leases recognised as an expense in the period were $7.3 million (2017: $4.6 million).
Operating lease payments represent rentals payable by the Group for certain of its leased properties. Manufacturing and laboratory
facilities are subject to 5 to 20-year leases, some of which have a lease break three years prior to the conclusion of the lease at the
Group’s option. Office properties are subject to 1 to 10-year leases.
During the year ended 30 September 2016, the Group signed a commercial growing agreement with an external supplier to produce
plant material for use in the Epidiolex development programmes and commercial release. This agreement commenced on 1 January
2017 and includes multiple fee elements designed to incentivise cost-efficient, reliable production volumes of raw materials for use in
research, development and commercial activities.
As part of the accounting treatment for this agreement a component operating lease was identified under the requirements of IFRIC 4
Determining Whether an Arrangement Contains a Lease. Rental payments commenced on 1 January 2017 and continue over a five-year
non-cancellable period. Future minimum lease payments associated with this operating lease are included in the table shown above.
Other gross payments associated with this agreement, excluding operating lease rentals and capital commitments outlined above, fall
due as follows:
Within one year
Between two and five years
The Company has no commitments for future minimum lease payments under non-cancellable operating leases.
Group
31 December
2018
$000s
30 September
2017
$000s
12,284
24,295
36,579
11,986
39,996
51,982
75
GW Pharmaceuticals plc | Annual Report and Accounts 2018 26. Related Party Transactions
Remuneration of Key Management Personnel
The remuneration of the Directors, who are the key management personnel of the Group, is set out below in aggregate for each of the
categories specified in IAS 24 Related Party Disclosures.
Short-term employee benefits
Post-employment benefits
Share-based payments
15 months to
31 December
2018
$000s
12 months to
30 September
2017
$000s
6,875
58
19,417
5,291
107
9,240
26,350
14,638
Key management personnel are defined for the purpose of disclosure under IAS 24 as the members of the Board and Executive Officers.
Other Related Party Transactions
Group
The Group had no material related party transactions which might reasonably be expected to influence decisions made by the users of
these Financial Statements.
Company
During 2018, the Company advanced funds to GW Research Limited, in order to fund Group pipeline research and development
activities. This took the form of a long-term loan, bearing interest at 5% per annum. The balance due to the Company at 31 December
2018 was $662.0 million (30 September 2017: $446.9 million). As a long-term loan, this has been disclosed within the Company
balance sheet as an investment – see Note 27.
At 31 December 2018, the amount due from GW Pharma Limited to the Company was $182.1 million (30 September 2017: $60.1 million).
At 31 December 2018, the amount due from the Company to Greenwich Biosciences, Inc. was $0.3 million (30 September 2017: $0.3 million).
27. Investments
Group Investments
Company
At 1 October 2016
Add capital contribution in respect of share-based payment charge
Additional funds advanced during year
Foreign exchange
At 1 October 2017
Add capital contribution in respect of share-based payment charge
Additional funds advanced during period
Foreign exchange
At 31 December 2018
Loans to
Group
undertakings
$000s
276,384
–
153,894
16,624
Investments
$000s
117,491
15,143
–
4,747
137,381
39,742
–
(1,836)
446,902
–
224,420
(9,162)
Total
$000s
393,875
15,143
153,894
21,371
584,283
39,742
224,420
(10,998)
175,287
662,160
837,447
76
Notes to the Consolidated Financial Statements continuedFor the 15 months ended 31 December 2018 and 12 months ended 30 September 2017GW Pharmaceuticals plc | Annual Report and Accounts 2018 The Company has investments in the following subsidiary undertakings:
Name of Undertaking
United Kingdom
GW Pharma Limited
GW Research Limited
GWP Trustee Company Limited
Cannabinoid Research Institute Limited
G-Pharm Limited
Sovereign House, Vision Park, Histon, Cambridgeshire, CB24 9BZ
United States
Greenwich Biosciences, Inc.
5750 Fleet Street, Carlsbad, California, United States
Australia
GW Pharmaceuticals Australia Pty Limited
Suite 2, Level 10, 45 Williams Street, Melbourne, Australia
Germany
GW Pharma (Germany) GmbH
Landsberger Strasse 155, 80687 Munich, Germany
Italy
GW Pharma (Italy) S.R.L.
Viale Abruzzi, 94 Cap 20131, Milan, Italy
Netherlands
GW Pharma International BV
Prins Bernhardplein 200, 1097JB Amsterdam
Type of
ownership
Activity
Direct
Direct
Indirect
Indirect
Indirect
Production and development
Research and development
Employee share ownership
Dormant
Dormant
% Holding
100
100
100
100
100
Direct
Commercialisation and research services 100
Direct
Dormant
Direct
Dormant
Direct
Dormant
Indirect
Commercial
100
100
100
100
All the subsidiary undertakings are included in the consolidated accounts, and all holdings are of ordinary voting shares.
During the period ended 31 December 2018, Guernsey Pharmaceuticals Limited, a dormant subsidiary company under 100% indirect
ownership of GW Pharmaceuticals Plc, was dissolved.
28. Subsequent Events
In June 2018, the Group received a Rare Pediatric Disease Priority Review Voucher (“PRV”) from the US FDA on their approval of
Epidiolex in the United States. This PRV entitles the Group to request a priority review of a subsequent US drug application that would
otherwise not qualify for a priority review. At 31 December 2018 the PRV is held on the balance sheet at a carrying value of $nil, which
equates to its historic cost.
On 15 March 2019 subsequent to the period end, the Group completed the sale of its Rare Pediatric Disease Priority Review Voucher
(“PRV)” for $105 million. The Company had received the PRV from the FDA in connection with the approval of Epidiolex.
77
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Advisers
Registered Office
GW Pharmaceuticals plc
Sovereign House
Vision Park
Histon
Cambridgeshire CB24 9BZ
United Kingdom
T: +44 (0)1223 266800
F: +44 (0)1223 235667
E: info@gwpharm.com
Registered Number
04160917 England and Wales
Solicitors to the Company
Mayer Brown LLP
201 Bishopsgate
London EC2M 3AF
Auditor
Deloitte LLP
2 New Street Square
London EC4A 3BZ
Principal Bankers
HSBC Bank plc
70 Pall Mall
London SW1Y 5EZ
Public Relations Advisers
FTI Consulting
Holborn Gate
Southampton Buildings
London WC2A 1PB
Registrars
Link Asset Services
6th Floor
65 Gresham Street
London EC2V 7NQ
ADR depositary
Citibank
National City Nominees
Citigroup Centre
33 Canada Square
Canary Wharf
London E14 5LB
dcc.adr@citi.com
Cautionary statement:
This Annual Report 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 (cannabidiol) oral solution and Sativex
(nabiximols) and the safety profile and commercial potential of
EPIDIOLEX and Sativex. 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 Sativex, EPIDIOLEX 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 US
Securities and Exchange Commission, including the most recent
Form 10-KT filed on 28 February 2019. 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.
78
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Notes
79
GW Pharmaceuticals plc | Annual Report and Accounts 2018 Notes
80
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Sovereign House
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Histon
Cambridgeshire
CB24 9BZ
United Kingdom
T: +44 (0)1223 266800
F: +44 (0)1223 235667
www.gwpharm.com
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