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| Share Name | Share Symbol | Market | Type | Share ISIN | Share Description |
|---|---|---|---|---|---|
| GW Pharm. | LSE:GWP | London | Ordinary Share | GB0030544687 | ORD 0.1P |
| Price Change | % Change | Share Price | Bid Price | Offer Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
|---|---|---|---|---|---|---|---|---|---|---|
| 0.00 | 0.00% | 735.00 | 0.00 | 01:00:00 |
| Industry Sector | Turnover | Profit | EPS - Basic | PE Ratio | Market Cap |
|---|---|---|---|---|---|
| 0 | 0 | N/A | 0 |
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RNS Number:1844G
GW Pharmaceuticals PLC
15 January 2003
Embargoed until 0700 15 January 2003
GW Pharmaceuticals plc
("GW" or "the Company")
Preliminary Results for the Year Ended 30 September 2002
GW Pharmaceuticals plc, the company licensed by the UK Home Office
to work with cannabis and a range of controlled drugs for medical
research purposes, announces its preliminary results for the year
ended 30 September 2002.
Highlights
- Regulatory dossier to be submitted to the Medicines Control
Agency in first quarter of 2003
- Target timescale for first product launch brought forward from
2004 to 2003
- Commercial discussions underway with potential marketing and
distribution partners in a number of territories
- Scale-up process for commercial production complete
- Positive results from four Phase III clinical trials in
Multiple Sclerosis and Neuropathic Pain
- Five additional Phase III clinical trials ongoing, including
pain in cancer and spinal cord injury
- Launch of Home Office-backed initiative in drug addiction
treatment to develop methadone and diamorphine products in
conjunction with GW's proprietary dispensing technology
- Net loss for year in line with expectations at #11.2 million
- Year end cash resources #20.2 million
Dr Geoffrey Guy, Executive Chairman, commented: "This has been a
year which has seen GW achieve its most important milestones to
date. In particular, the positive results from four Phase III
clinical trials take GW a major step closer to the launch of the
Group's, and the world's, first non-smoked prescription cannabis-
based medicine. Originally anticipated to take place in 2004, we
are now planning for a possible launch during 2003.
"We have a great deal to look forward to in the coming year. In the
UK, we are on track to submit the regulatory application for our
first product in the first quarter of 2003. Subject to regulatory
approval, we anticipate initial UK market launch towards the end of
the year. Discussions are now underway with a number of
pharmaceutical companies regarding the commercialisation of GW's
initial products around the world. We also look forward to the
results of more Phase III trials which are intended to expand the
market for the initial product. At the same time, we aim to report
continuing progress with the clinical trials in our anti-addiction
programme."
A presentation for analysts is taking place today at 09.30 at Weber
Shandwick Square Mile, Fox Court, 14 Gray's Inn Road, London WC1.
An audio webcast of the presentation will be available on GW's
website at www.gwpharm.com from 15.00 today.
Enquiries:
GW Pharmaceuticals plc (15/01/03) 020 7067 0700
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith/Graham Herring
GW Pharmaceuticals plc
("GW" or "the Company")
Preliminary Results for the Year Ended 30 September 2002
Managing Director's Review
The Group has made considerable progress during the course of this
year. The clinical trials programme for our cannabis-based
medicines has proceeded ahead of schedule and yielded better than
expected results. In addition, we have diversified our interests
into the area of drug addiction treatment with the establishment of
methadone and diamorphine research programmes.
The Group has carried out its extensive research and development
operations whilst at the same time gearing up production in
anticipation of the forthcoming launch of its first product. We
have scaled up production both in-house and through external
contractors and now have sufficient capacity to manufacture product
for significant numbers of patients.
As a consequence of this year's progress, we are confident that we
will be in a position to beat our original expectations of
delivering our first product to market in 2004. Our first
regulatory submission is planned for the first quarter of 2003 and
the target timescale for launch has now been moved forward to 2003.
Commercialisation
The Group has consistently stated its commercial strategy to be to
enter into third party arrangements following Phase III clinical
trial results in order to secure optimum commercial terms. Having
recently announced positive trial results, we are now progressing
discussions with a number of pharmaceutical companies in order to
establish the commercial arrangements necessary to launch our
initial product around the world. We expect to conclude our first
partnerships in the first half of 2003.
Clinical Trials Progress
This has been a landmark year for the Group with the progress of the
clinical trials programme. During the first half of the year, we
established the largest programme of trials ever undertaken into the
medicinal effects of cannabis. By the end of the year, we announced
positive results from four Phase III trials as well as three Phase
II trials. These trials have shown our cannabis-based medicines to
have a uniquely broad profile of therapeutic activity in a range of
serious neurological conditions. The trials confirm that these
medicines have the potential to make a unique contribution towards
improving the quality of life of patients with a number of chronic
disabling diseases.
Phase III Trials
Preliminary analysis has revealed positive results from each of the
four completed Phase III clinical trials in patients suffering from
Multiple Sclerosis ("MS") and neuropathic pain. These results will
be submitted for peer-review publication during the course of 2003.
GW's four randomised, double-blind, placebo-controlled Phase III
trials included approximately 350 patients. In the trials, the
THC:CBD medicine achieved statistically significant reductions in
neuropathic pain in comparison with placebo in patients with MS and
other conditions, as well as statistically significant improvements
in other symptoms of MS, most notably spasticity and sleep
disturbance. These findings are consistent with results from Phase
II trials.
In addition to the four completed trials, GW has a further five
Phase III trials, including pain in cancer and spinal cord injury,
in progress. These trials are scheduled to report during 2003.
Phase II Trials
During the course of the year, positive results from three Phase II
clinical trials, including approximately 80 patients, were presented
at scientific conferences in the UK and US. These trials
demonstrated relief of neuropathic pain, improvement in sleep,
improvements in spasticity, bladder dysfunction and muscle spasm.
A potentially important observation from these trials is that our
CBD medicine produced statistically significant relief of pain in
comparison with placebo. This result is of particular interest as
CBD is a non-psychoactive component of cannabis that was generally
thought to have primarily anti-inflammatory rather than analgesic
properties. If this finding can be confirmed in a Phase III study,
a CBD product may hold out great promise in a much wider range of
clinical conditions than originally envisaged.
Phase I Trials
In total, GW has now carried out 11 Phase I studies, evaluating 18
cannabinoid preparations in 114 subjects. The trials have
successfully demonstrated that GW's various formulations of cannabis-
based medicine show good bioavailability and are well tolerated.
Safety Profile
All trials have confirmed that GW's cannabis-based medicines have an
excellent safety profile. Self-titration (adjustment) of their dose
enabled most patients to achieve improvement in their symptoms
without incurring a level of unwanted effects which would interfere
with day-to-day living. At the end of 2002, GW has data accruing
from over 300 accumulated patient-years of exposure to the medicine.
Advanced Dispensing System
The Advanced Dispensing System (ADS) technology has been under
development by GW for a number of years. ADS provides the ability
to monitor and, if required, control drug usage in real time. The
technology also provides a secure and tamper-proof means of
dispensing controlled drugs. ADS can be applied to a wide range of
drugs in a range of dosage forms.
As a result of this progress, we have established the first
commercial programme involving ADS, dispensing methadone and
diamorphine in the treatment of drug addiction. If this research is
successful, we will look to exploit further opportunities for ADS
over the coming few years.
Methadone/Diamorphine
GW has identified two new product opportunities exploiting the
benefits of ADS - methadone and diamorphine. These products present
the Group with the prospect of addressing substantial markets within
a short period of time.
The GW team has developed formulations of methadone and diamorphine
appropriate for use with ADS. In collaboration with the National
Addiction Centre, the methadone product is now commencing trials in
heroin addicts. If successful, these trials will be extended around
the UK. Initial commercial sales may follow shortly thereafter. The
diamorphine project is longer term.
The business model for this opportunity is attractive - by
incorporating previously approved drugs into the ADS dispensing
system, GW has the potential to develop new value-added products in
rapid timescales and with reduced development risks as compared with
conventional drug development programmes.
GW revenues will be obtained through the sale of ADS cartridge
formulations of methadone and diamorphine. With an estimated
250,000 addicts in the UK alone, the market opportunity is
substantial. Further, government policy in the UK and other
countries around the world is recognising the value in funding drug
treatment programmes. Having already secured endorsement for GW's
programme from the UK Home Office and from governmental meetings
outside the UK, GW is strategically well placed to derive
substantial value from this business.
Production Scale-Up
A key area of operational focus this year has been preparing GW's
cultivation and production capabilities for market launch. All key
arrangements relating to commercial scale production are now in
place.
In the first half of the year, an additional indoor cultivation
facility was established. This facility doubled in-house growing
capacity to over 30 tonnes of plant material per year. We have also
entered into arrangements with a third party contractor to cater for
a significant further step-up of growing capacity (doubling capacity
to 60 tonnes of plant material) to cater for product launch.
GW's extraction facility has been upgraded to meet appropriate
standards of Good Manufacturing Practice (GMP) ahead of product
launch. This facility can cater for significant commercial sales of
product. We have also established commercial scale GMP final
product manufacturing facilities with a contract manufacturing
partner. This will meet production needs for significant commercial
quantities of product.
Premises & Staff
GW operates on three principal sites in the UK. Additional
laboratory and office space has been required during the course of
the year as the number of research projects has expanded and staff
numbers increased. The Group had 110 employees at the year-end as
compared with 85 at the start of the financial year. Although staff
numbers continue to rise, the rate of headcount growth has slowed
as our research and development activities mature and our production
capabilities reach commercial scale.
Intellectual Property Rights
GW continues to adopt an aggressive approach to securing
intellectual property rights to protect techniques and technologies
involved in the development programme. We are seeking protection in
the form of plant variety rights, plant patents, methods of
extraction patents, drug delivery device patents, patents on
compositions of matter for the delivery of cannabis, methods of use
patents, design copyright on devices, and trademarks.
In the last year our intellectual property portfolio has developed
considerably. The patent portfolio has more than doubled in size
and as of the year end comprised 19 patent families extending to
territories around the world. In addition, we have obtained design
protection in the UK for our ADS device and cartridge. Design
registrations have also been filed in other countries around the
world. We continue to protect our unique plant varieties and
currently have 29 plant variety rights pending. This year we have
also started to develop a trademark portfolio and this currently
comprises 17 marks.
Public Affairs
During the year, the UK government announced its intention to relax
cannabis laws with regard to the criminal penalties for possession
and use of cannabis. This change in criminal penalties has no
direct relevance to GW's research programme - GW's research is still
carried out under Home Office licence and its prescription cannabis-
based medicine will be licensed by regulatory authorities in
accordance with standard pharmaceutical practice on the basis of
proven quality, safety and efficacy. The same strict regulations and
requirements for a full pharmaceutical development programme apply
to all efforts to carry out cannabis research in the UK.
In addition, the UK Department of Health has recommended that
cannabis-based medicines be included in the list of drugs to be
reviewed by the National Institute for Clinical Excellence (NICE) in
2003. This review is scheduled to conclude in the first half of
2004. A positive recommendation from NICE would mean that GW's
product would automatically be available nationwide on the National
Health Service.
Outlook
During 2003, we will be progressing our first regulatory filing with
the UK Medicines Control Agency. At the same time, we aim to
establish the commercial arrangements necessary to launch our
initial product in the UK. In addition to preparing for the
anticipated initial UK market launch, GW plans to enter into
partnerships to cater for future international launches. We also
look forward to the results of more Phase III trials which are
intended to expand the market for the initial product. At the same
time, GW continues to progress its pipeline of other cannabinoid
products to address further commercial opportunities. The progress
of our first non-cannabinoid programmes in the area of drug
addiction treatment utilising the ADS technology also provides
strong opportunities for growth over the next few years.
Justin Gover
Managing Director
Financial Review
Following the positive Phase III clinical trial results, the Group
is set during 2003 to begin the transition from being purely a cash
consuming research and development company to one which generates
revenues from commercial relationships and product sales whilst
continuing to fund its research and development programmes.
Results of Operations
The Group loss for the year ended 30 September 2002 increased to
#11.2m (2001: #6.9m) in line with expectation. This increase in
research and development and administrative expenditure reflects
planned increases as described below.
Research and development expenditure, which is expensed as incurred,
increased to #10.7m (2001: #6.6m) as a result of the continuing
expenditure as outlined in the Managing Director's Review. In
particular, expenditure has been targeted heavily towards the large
volume of clinical trials undertaken during the course of the year.
Management and administrative expenses increased to #2.3m (2001:
#1.1m) as a result of the increasing size of the Group's activities.
Management and administrative expenses (including amortisation of
goodwill) account for 17% (2001: 14%) of total expenditure with
research and development and production scale-up expenditure
accounting for the remaining 83% (2001: 86%).
2002 has been a year of ongoing expansion for all areas of activity
in the Group as we have continued to push towards our aim of product
approval and product commercialisation. The average headcount of
the Group for the year was 102 (2001: 48) and we ended the year with
110 employees (2001: 85).
Capital expenditure was steady at #0.7m (2001: #0.9m) as the Group
continues to improve and enlarge its research and development
capability and prepare for product launch. The Group benefited from
net interest income of #0.8m (2001: #0.5m).
Research and Development Tax credit
As a result of legislation allowing small and medium sized companies
to claim research and development tax credits on qualifying
expenditure, the Group has claimed #0.94m (2001: #0.35m) which is
shown as a credit to the profit and loss account. This is subject
to agreement with the Inland Revenue.
Share Issue
On 29 August 2002, 4,097,185 new ordinary shares were issued at
#1.09 per share. After expenses the share issue raised approximately
#4.4m. The issue resulted from the considerable amount of interest
and enthusiasm shown by the investment community following the
announcement of the ADS technology and the additional opportunities
that it presents to the Group.
Liquidity and Cash Resources
The Group's net funds comprise cash balances together with amounts
held on short term deposit. Cash and short term deposits at 30
September 2002 totalled #20.2m (2001: #25.7m). The net cash outflow
during the year (before financing and management of liquid
resources) was #9.9m (2001: #6.6m).
David Kirk
Finance Director
- Ends -
Enquiries:
GW Pharmaceuticals plc (15/01/03) 020 7067 0700
Dr Geoffrey Guy, Chairman (Thereafter) 01980 557000
Justin Gover, Managing Director
Weber Shandwick Square Mile 020 7067 0700
Kevin Smith/Graham Herring
GW Pharmaceuticals plc
Preliminary Results for the Year Ended 30 September 2002
Consolidated Profit and Loss Account
2002 2001
Notes #000's #000's
Turnover - -
Research and development costs (10,748) (6,642)
Management and administrative expenses (2,251) (1,083)
_______ ________
Operating loss (12,999) (7,725)
Interest receivable 831 514
Interest payable (1) (1)
________ ________
Loss on ordinary activities before taxation (12,169) (7,212)
Tax credit on loss on ordinary activities 2 942 347
________ ________
Loss on ordinary activities after taxation
being retained loss for the financial year (11,227) (6,865)
________ ________
Loss per share - basic and diluted 3 (11.6p) (9.0p)
All activities relate to continuing operations.
The Group has no recognised gains and losses other than the losses
above and therefore no separate statement of total recognised gains
and losses has been presented.
GW Pharmaceuticals plc
Preliminary Results for the Year Ended 30 September 2002
Consolidated Balance Sheet
Notes At 30 At 30
Sept Sept
2002 2001
#000's #000's
Fixed assets
Intangible assets - goodwill 6,635 6,992
Tangible assets 1,002 740
________ ________
7,637 7,732
________ ________
Current assets
Debtors 1,274 976
Cash held on deposit as short term investment 18,271 24,000
Cash at bank and in hand 1,929 1,650
________ ________
21,474 26,626
Creditors: Amounts falling due within one
year (3,258) (1,762)
________ ________
Net current assets 18,216 24,864
________ ________
Total assets less current liabilities 25,853 32,596
________ ________
Creditors: Amounts falling due after more
than one year (18) -
Provisions for liabilities and charges (38) (20)
________ ________
Net assets 25,797 32,576
________ ________
Capital and reserves
Called-up share capital 100 96
Share premium account 4 27,935 23,491
Other reserves 4 19,262 19,262
Profit and loss account 4 (21,500) (10,273)
________ ________
Equity shareholders' funds 5 25,797 32,576
________ ________
GW Pharmaceuticals plc
Preliminary Results for the Year Ended 30 September 2002
Consolidated Cash Flow Statement
Notes
2002 2001
#000's #000's
Net cash outflow from operating activities 6 (10,425) (6,317)
Returns on investments and servicing of
finance 857 470
Taxation 347 93
Capital expenditure (667) (876)
Acquisitions and disposals - 30
________ ________
Cash outflow before management of liquid
resources and financing (9,888) (6,600)
Management of liquid resources 5,729 (22,700)
Financing 4,438 30,521
________ ________
Increase in cash during the year 279 1,221
________ ________
Notes:
1 Basis of presentation
The preliminary statement covers the year ended 30 September 2002. It
has been prepared using the same accounting policies as those adopted
in preparing the statutory accounts for the year ended 30 September
2001, with the exception that during the year the Group adopted FRS 19
'Deferred Tax'. There was no effect on adopting FRS 19 to the Group.
The prior year cash balance has been restated to reflect the maturity
profile of the cash and short term investment balances.
The Board of Directors of the Company approved the statement on 14
January 2003.
The 2002 and 2001 accounts received unqualified reports from the
Auditors and did not contain any statements under S237(2) or (3) of
the Companies Act 1985. The 2002 accounts will be filed with the
Registrar of Companies following the Annual General Meeting. The 2001
accounts have been filed. The statutory accounts will be issued to
shareholders shortly, together with the notice for the Annual General
Meeting to be held on 26 February 2003 at 11am at Porton Down Science
Park, Salisbury, Wiltshire.
The following information does not constitute the Company's statutory
accounts under section 240 of the Companies Act 1985 for the year
ended 30 September 2002 but is derived from those accounts.
2 Tax credit on loss on ordinary activities
The tax credit of #942,000 (2001: #347,000) has arisen as a result of
the research and development expenditure claimed under the Finance Act
2000.
At 30 September 2002 the Group had trading losses of approximately
#18.7m (2001: #9.5m) available to carry forward against future tax
liabilities.
The tax credit and trading losses to be carried forward for the year
are subject to the agreement of the Inland Revenue.
3 Loss per share
The calculations of loss per share are based on the following
losses and numbers of shares.
Basic Diluted
_______________ _______________
2002 2001 2002 2001
#000's #000's #000's #000's
Loss for the financial year (11,227) (6,865) (11,227) (6,865)
________ ________ ________ ________
2002 2001
Number Number
of shares of shares
Weighted average number of shares: 96,386,304 75,949,639
__________ __________
Since the Group reported a net loss, diluted loss per share is equal
to basic loss per share.
4 Reserves
Share
premium Other Profit and
account reserves loss account Total
Group #000's #000's #000's #000's
At 1 October 2001 23,491 19,262 (10,273) 32,480
Equity share issue 4,462 - - 4,462
Expense of equity share issue (18) - - (18)
Retained loss for the year - - (11,227) (11,227)
________ ________ ________ ________
At 30 September 2002 27,935 19,262 (21,500) 25,697
________ ________ ________ ________
5 Reconciliation of movements in Group shareholders' funds
2002 2001
#000's #000's
Loss for the financial year (11,227) (6,865)
New ordinary shares issued net of expenses 4,448 37,686
_______ _______
Net (decrease) / addition to shareholders' funds (6,779) 30,821
Opening shareholders' funds 32,576 1,755
_______ _______
Closing shareholders' funds 25,797 32,576
_______ _______
6 Reconciliation of operating loss to net cash outflow from
operating activities
2002 2001
#000's #000's
Operating loss (12,999) (7,725)
Depreciation charge 405 259
Amortisation of goodwill 357 140
Loss on disposal of fixed assets 36 -
Decrease / (increase) in debtors 271 (483)
Increase in creditors 1,505 1,492
________ ________
Net cash outflow from operating activities (10,425) (6,317)
________ ________
This information is provided by RNS
The company news service from the London Stock Exchange
END
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