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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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GW Pharmaceuticals PLC
19 June 2007
GW Pharmaceuticals plc
("GW" or "the Group")
Interim Results For The Six Months Ended 31 March 2007
Porton Down, UK, 19 June 2007: GW Pharmaceuticals plc (AIM: GWP), the developer
and manufacturer of a range of new cannabinoid medicines, including Sativex(R),
announces its interim results for the six months ended 31 March 2007.
OPERATIONAL HIGHLIGHTS
* Qualifying Notice for approval of Sativex in the relief of cancer pain
received from Health Canada (announced separately today)
* Sativex US licence agreement signed with Otsuka, including $18m signature
fee, additional milestone payments up to $255m as well as a significant long
term commercial supply price and royalty
* Discussions at an advanced stage with Otsuka to enter into global
cannabinoid research collaboration in the field of CNS and cancer treatment
* Positive discussions with FDA on US development programme - first large
scale US clinical trial in cancer pain due to start during summer 2007
* European regulatory application process ongoing for Sativex in the relief
of MS Spasticity
* THCV, a potential treatment for obesity and metabolic disorders, enters
Phase I clinical trials
FINANCIAL HIGHLIGHTS
* Net loss for the period of #6.7m (2006: #6.9m), in line with expectations
* Cash and short term deposits at 31 March 2007 of #21.9m
* Net cash inflow for period of #2.0m
Dr Geoffrey Guy, GW's Chairman, said: "The first half of the year has been one
of considerable progress, notably in respect of our activities in North America.
The Sativex US licence agreement with Otsuka is a significant achievement and
serves to validate further the potential of this important new medicine. In
Canada, we are pleased to have announced today further regulatory success with
receipt of the Qualifying Notice for the approval of Sativex for the relief of
cancer pain. Today's news is important not only for Canada, but also for our
prospects in the US, where cancer pain represents the lead target indication.
"In the second half of the year, we look forward to the start of our first large
scale US clinical trial, to be fully funded by Otsuka, and the approval and
launch of the cancer pain indication in Canada. In addition, the European
regulatory submission for Sativex in MS spasticity is expected to conclude. We
also expect to sign a global cannabinoid research collaboration with Otsuka and
to see progress of early stage programmes under this arrangement, as well as
progress with the early clinical development of THCV as a potential treatment
for obesity and related metabolic disorders."
An analyst presentation of the interim results is being held today at 09.30 at
Financial Dynamics, Holborn Gate, 26 Southampton Buildings, London WC2A 1PB.
Please contact Gemma Cross Brown at Financial Dynamics on +44 20 7269 7125 for
details. An audio webcast of the presentation will be available on GW's website
at www.gwpharm.com later this afternoon.
Enquiries:
GW Pharmaceuticals plc (19/06/07) + 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Financial Dynamics + 44 20 7831 3113
David Yates / Ben Atwell
GW Pharmaceuticals plc
("GW" or "the Group")
Interim Results For The Six Months Ended 31 March 2007
During the first half of the year, GW entered into its most significant
agreement to date with the signing of a major long term strategic cannabinoid
alliance with Otsuka Pharmaceutical Co., Ltd, one of Japan's largest
pharmaceutical companies and a world leader in Central Nervous System (CNS)
research. This relationship has commenced with the licensing to Otsuka of
Sativex for development and commercialisation in the United States. We expect to
extend the collaboration further in the near future by entering into a global
cannabinoid research agreement. Having completed the US licence for Sativex, GW
now has successfully partnered this important product across Europe (Bayer in
UK, Almirall in continental Europe) and North America (Bayer in Canada, Otsuka
in the US). Taken together, the licensing terms for this product total $51m of
signature fees, $376m of milestone payments as well as substantial long-term
supply price and royalty provisions.
The clinical and regulatory programme for Sativex continues to progress as
planned. We are delighted to have announced separately today that Health Canada
has issued a Qualifying Notice for Sativex to be approved in the relief of
cancer pain. Cancer pain is an important indication for Sativex, particularly in
North America, since it also represents the lead clinical programme in the
United States. We expect Sativex to be available for prescription to patients
with cancer pain in Canada in the autumn. In Europe, the regulatory process for
approval of Sativex in MS spasticity is ongoing and expected to conclude later
this year. In addition, a Phase III trial in MS neuropathic pain is recruiting
as planned and due to report results in early 2008. We continue to publish
positive clinical study results in peer-reviewed journals, including the
journals Multiple Sclerosis and The European Journal of Neurology.
Beyond Sativex, we continue to invest in early stage cannabinoid research to
select and develop our next product candidates. We have recently started a Phase
1 clinical study of THCV, a potential treatment for obesity, diabetes and other
metabolic disorders. Our early stage research activities are expected to expand
significantly as soon as we have concluded the proposed cannabinoid research
collaboration agreement with Otsuka.
OTSUKA
Sativex US Licence
In February 2007, GW granted Otsuka an exclusive licence to develop and market
Sativex, GW's lead product, in the US. GW will be responsible for the
manufacture and supply of Sativex to Otsuka.
The financial terms of this agreement include a $18m signature fee, which has
been received, further milestone payments to GW of up to $255m as well as a long
term commercial supply price and royalty. In addition, Otsuka will bear the
costs of all US development activities for Sativex in the treatment of cancer
pain, additional indications and future formulations.
Cannabinoid Research Collaboration
GW and Otsuka are currently in detailed discussions to enter into a global
cannabinoid research collaboration in the field of CNS and cancer treatment.
Under this collaboration, Otsuka would fund the evaluation of a range of
cannabinoids as drug candidates within the research field, with a view to
selecting the most promising candidates for full clinical development,
regulatory approval and global commercialisation. Products selected for
commercialisation would be the subject of a licence from GW. Under the terms of
this licence, Otsuka would fund the global development of selected products and
GW would receive commercially reasonable financial terms.
SATIVEX REGULATORY STRATEGY
The clinical and regulatory strategy for Sativex is focused on four specific
therapeutic indications, each of which represents a distinct regulatory
opportunity and each of which requires a distinct set of clinical efficacy data.
These indications are as follows:
* MS Spasticity
* MS Neuropathic Pain
* Cancer Pain
* Peripheral Neuropathic Pain
Each of these target indications is supported by existing positive Phase III
data and will continue to be supplemented by further late stage trials over the
next few years in order to supplement globally approvable regulatory packages
and provide more data to support the marketing of the product post approval.
The lead indication for Sativex differs across different regions of the world.
In the United States, Cancer Pain is the chosen initial target. In Canada, MS
Neuropathic Pain is the first approved indication, which is being followed by
Cancer Pain. In Europe, the entry point for Sativex is MS, with MS Spasticity
initially targeted, followed closely by MS Neuropathic Pain.
This clinical and regulatory programme is designed to provide multiple
opportunities over the next few years to obtain approvals for Sativex across
various indications in a number of territories.
GEOGRAPHIC REVIEW
United States
In 2006, the Food & Drug Administration (FDA) permitted Sativex to enter
directly into late stage development in the US for the treatment of pain in
patients with advanced cancer that has not been adequately relieved by opioid
medications. Since the signature of the Otsuka licence agreement, GW and Otsuka
have held positive discussions with FDA with regard to the US development plan,
including with respect to the first US pivotal efficacy clinical trial, which is
to be a Phase II/III Cancer Pain dose ranging study.
Under the terms of the Otsuka agreement, all US clinical trials are to be funded
by Otsuka. GW and Otsuka are jointly overseeing all US clinical development and
regulatory activities. For the first Cancer Pain indication, GW has retained
responsibility for carrying out such activities, at Otsuka's cost. GW will also
continue to be the holder of the IND until the filing of a New Drug Application,
which will be in Otsuka's name.
Preparations are at an advanced stage for the first US study, which is expected
to commence during summer 2007. GW has worked successfully with the Drug
Enforcement Agency (DEA) to ensure that investigative sites are appropriately
licensed and that the necessary import licences for supply of product have been
received. Institutional Review Board (IRB) approvals have also already been
obtained at a number of investigative sites.
This Phase II/III trial aims to recruit over 300 patients, principally at sites
in the US. It is expected that results from the study will be available towards
the end of 2008.
The current US development program anticipates two further Phase III trials to
be conducted during 2009, prior to a subsequent submission of a New Drug
Application to FDA. All data generated in the US will also be available to GW
for submission to regulatory authorities in Europe and elsewhere.
Canada
Sativex is approved and marketed in Canada as adjunctive treatment for the
symptomatic relief of neuropathic pain in Multiple Sclerosis ("MS") in adults.
The product is exclusively marketed in Canada by Bayer.
In October 2006, GW filed an application with Health Canada to extend the
Canadian approval to include the use of Sativex in the relief of Cancer Pain. GW
has announced separately today that Health Canada, the Canadian regulatory
agency, has issued a Qualifying Notice for this approval. Following agreement of
required documentation in the next few months, we expect to receive this
regulatory approval in the late summer.
The approved Cancer Pain indication will be "adjunctive analgesic treatment in
adult patients with advanced cancer who experience moderate to severe pain
during the highest tolerated dose of strong opioid therapy for persistent
background pain."
Europe
In September 2006, GW announced it had filed a regulatory submission in four
selected European countries for Sativex for the symptomatic relief of spasticity
in people with MS. The filing has been made under the "decentralised procedure"
in the UK, Spain, Denmark and the Netherlands. Under this procedure, the UK is
acting as Reference Member State and consults with the three other countries.
If successful, this procedure would lead to the simultaneous approval of Sativex
in these countries for the MS Spasticity indication. The regulatory process is
ongoing and expected to conclude in the second half of 2007.
Sativex is licensed exclusively to Almirall, Spain's largest pharmaceutical
company, in Europe (ex-UK). In the UK, Sativex is exclusively licensed to Bayer
HealthCare.
The first opportunity to expand the approval in Europe into other indications is
expected to be for MS Neuropathic Pain.
Spain
Since January 2006, Sativex has been supplied to selected patients in Catalonia
in Spain under an agreement with the Health Department of The Regional
Government of Catalonia. At present, a few hundred patients are participating
and new patients continue to be enrolled. The Catalan Health Department have
stated publicly that they are very pleased with the response to this programme
by opinion leaders and patients.
UK
Sativex is being supplied as an unlicensed medicine to patients in the UK who
are in receipt of a prescription. This includes patients who have previously
been on clinical trials, as well as other patients who have been recommended to
take Sativex by their physician. Licences issued by the Home Office mean that
Sativex may be supplied directly from the UK manufacturing site and dispensed by
local pharmacies. GW charges for provision of the medicine under these
circumstances.
To date, Sativex has been prescribed in the UK to over 1,000 patients. The
majority of prescriptions are being funded by the National Health Service.
SATIVEX CLINICAL TRIALS PROGRAMME
MS Spasticity
The body of clinical evidence supporting the efficacy of Sativex in MS
Spasticity includes two pivotal Phase III trials, a pooled analysis, as well as
supportive data. This evidence has formed the basis of the current regulatory
submission in selected European countries.
In February, a leading neurology journal, The European Journal of Neurology,
published results of one of GW Phase III trials, which forms part of the current
regulatory submission, showing that Sativex significantly reduces intractable
spasticity (spasms and stiffness) in people with MS (1).
GW's strategy across all target indications is to continue to supplement its
data with further late stage trials over the next few years. For this reason, GW
plans to continue to generate data in this indication by commencing a further MS
Spasticity trial later this year.
MS Neuropathic Pain
GW has obtained approval for Sativex in Canada in the indication of Neuropathic
Pain in MS. This approval was obtained under the Canadian NOC/c policy on the
basis of a single positive Phase III trial which was published in the journal,
Neurology (2).
GW is currently conducting a second Phase III study in this indication, which is
expected to complete in early 2008. This 300 patient study is recruiting
patients in Canada, UK, Spain, France and the Czech Republic.
Following completion of this second Phase III trial, GW expects to have
sufficient data for a regulatory submission in Europe in this indication.
Cancer Pain
GW's Cancer Pain programme is being initiated in the US with a view to obtaining
approval from the FDA. These US trials will also form the basis of a European
regulatory application in this indication.
Peripheral Neuropathic Pain
GW has generated a body of clinical data to support the efficacy of Sativex in
peripheral Neuropathic Pain. In early 2007, two further Phase III studies
reported preliminary results. One of the studies, in 246 patients with
Neuropathic Pain characterised by allodynia (3), showed a positive result for
the responder analysis of the primary endpoint (the proportion of patients
obtaining a clinically meaningful improvement in pain relief), as well as two of
the key pain-related secondary efficacy endpoints. The results of the study in
297 patients with painful diabetic neuropathy were more difficult to interpret
due to an abnormally large placebo response.
These data contribute to a future regulatory filing in the use of Sativex as a
treatment for Neuropathic Pain and GW intends to continue to add to this
evidence base by conducting additional confirmatory trials in due course.
THCV CLINICAL PROGRAMME
In June 2007, GW commenced the clinical development programme of its novel
cannabinoid product, delta-9-tetrahydrocannabivarin (THCV). THCV has shown
promise in pre-clinical studies as a potential treatment for obesity, diabetes
and related metabolic disorders.
The first Phase I study, which is ongoing, is a randomised, double blind,
placebo controlled, dose escalation, safety and tolerability study of single
doses of THCV in twelve healthy volunteer subjects. The formulation is an
extract from a unique cannabis plant variety bred by GW scientists which
exhibits THCV as the principal cannabinoid component. The product is being
administered as an oral solution.
If this Phase I trial is successful, GW intends to progress the programme by
embarking on studies in obese subjects.
EARLY STAGE CANNABINOID RESEARCH
GW works closely with a network of world leading cannabinoid scientists in
exploring the potential of a range of cannabinoid molecules. This programme will
be expanded further upon signature of the anticipated research collaboration
with Otsuka with a view to generating a number of new product candidates for
development and commercialisation over the next few years.
FINANCIAL REVIEW
Turnover of #823,000 includes #423,000 relating to commercial sales of Sativex
in Canada and the UK. The remaining #400,000 relates to revenue recognised from
the #12m Almirall licence agreement signature fee, which is being recognised
over a 15 year period.
In February, the Sativex US licence agreement was signed with Otsuka, which
resulted in the receipt of a $18m (#9.2m) signature fee at the end of March. The
signature fee will be recognised as revenue over the life of the agreement with
effect from 1 April 2007, hence no revenue arising from this transaction has
been recognised in the current period.
Research and development expenditure decreased, in line with budget, to #6.2m
(2006: H1 #6.5m; H2 #6.6m).
Management and administrative expenses (including amortisation of goodwill)
increased to #2.0m (2006: H1 #1.7m; H2 #1.8m).
The adoption of FRS 20 (share-based payments) has resulted in a charge of
#666,000 in the six month period, compared to a prior period restatement of
#713,000 in the comparative period last year and #1,338,000 for the full year to
30 September 2006. All share options have been valued using the Black-Scholes
option-pricing model.
Operating losses of #8.1m (2006: #8.2m) were offset by interest income of #0.39m
and an R&D tax credit of #1.01m, resulting in a net loss after tax of #6.7m
compared to a restated #6.9m in the same period last year.
Net cash inflow, before management of liquid resources and financing, was #2.0m
compared to #4.2m in the comparable period last year.
As at 31 March 2007 GW had cash and short-term deposits totalling #21.9m.
Debtors at 31 March were #4.9m, which includes R&D tax credits receivable of
#3.0m (of which #2.0m was received in May 2007) and #1.2m of Spanish withholding
tax.
Total deferred income of #20.1m represents the unrecognised balances of the
non-refundable #12m Almirall and $18m (#9.2m) Otsuka signature fees. These will
be recognised as revenue in future periods.
The headcount as at 31 March 2007 was 123 compared to 120 as at 30 September
2006.
As indicated at the beginning of the year we expect overall R&D expenditure for
the year to be in line with that incurred in 2006.
Following a review by the Board, GW will be adopting International Financial
Reporting Standards ('IFRS') for the year ended 30 September 2008. Having
adopted FRS20 (share-based payments) in the current year, preliminary analysis
indicates that the overall impact of IFRS adoption will be minimal.
Board of Directors
GW previously announced that the Board has been carrying out a corporate
governance review process with regard to the proportion of independent
non-executive directors. During the first few months of 2007, this process was
completed with the appointment of two new independent non-executive directors,
James Noble and Richard Forrest, in place of David Mace and David Morrison, both
of whom have stood down from the Board. James Noble has also been appointed to
the newly created position of Deputy Chairman and is the nominated senior
independent director.
Summary and Prospects
The first half of the year has been one of considerable progress, notably in
respect of our activities in North America. The Sativex US licence agreement
with Otsuka is a significant achievement and serves to validate further the
potential of this important new medicine. In Canada, we are pleased to have
achieved further regulatory success through obtaining the Qualifying Notice for
approval of the cancer pain indication.
In the second half of the year, we look forward to the start of our first large
scale US clinical trial, to be fully funded by Otsuka, and the approval and
launch of the cancer pain indication in Canada. In addition, the European
regulatory submission for Sativex in MS spasticity is expected to conclude. We
also expect to sign the global cannabinoid research collaboration with Otsuka
and to see progress of early stage programmes under this arrangement, as well as
progress with the early clinical development of THCV as a potential treatment
for obesity and related metabolic disorders.
Enquiries:
GW Pharmaceuticals plc (19/06/07) + 44 20 7831 3113
Dr Geoffrey Guy, Executive Chairman (Thereafter) + 44 1980 557000
Justin Gover, Managing Director
Financial Dynamics + 44 20 7831 3113
David Yates / Ben Atwell
This news release may contain forward-looking statements that reflect the
Group's current expectations regarding future events, including the clinical
development and regulatory clearance of the Group's products. 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 the Group's research strategies, the
applicability of the discoveries made therein, the successful and timely
completion of clinical studies, including with respect to Sativex and the
Group's other products, the uncertainties related to the regulatory process, and
the acceptance of Sativex and other products by consumers and medical
professionals
Footnotes:
(1) Collin C, Davies P, Mutiboko IK, Ratcliffe S, for the Sativex Spasticity in
MS Study Group. Randomised controlled trial of cannabis based medicine in
spasticity caused by Multiple Sclerosis. European Journal of Neurology
(2007) 14 (3), 290-296
(2) D.J.Rog, T.J.Nurmikko, T.Friede, and C.A Young. Randomized, controlled
trial of cannabis-based medicine in central pain in multiple sclerosis.
Neurology 2005;65:812
(3) Allodynia is the occurrence of pain in response to a normally non-painful
stimulus (e.g. clothes touching against the skin). It is often intense and
can occur in patients suffering from a range of conditions that damage the
peripheral nerves (e.g. nerve lesions, post-herpetic neuralgia).
GW Pharmaceuticals plc
Consolidated profit and loss account
For the six months ended 31 March 2007 - Unaudited
Six months ended Six months ended Year ended
31 March 31 March 30 September
Notes 2007 2006 2006
Restated Restated
Unaudited Unaudited Audited
#000's #000's #000's
Turnover 2 823 733 1,981
Cost of sales (85) (92) (277)
__________ __________ __________
Gross Profit 738 641 1,704
Research and development costs (6,246) (6,461) (13,102)
Management and administrative expenses (1,962) (1,703) (3,468)
Share-based payment (666) (713) (1,338)
__________ __________ __________
Operating loss (8,136) (8,236) (16,204)
Interest receivable 393 426 929
__________ __________ __________
Loss on ordinary activities before taxation (7,743) (7,810) (15,275)
Tax credit on loss on ordinary activities 3 1,012 901 2,022
__________ __________ __________
Loss on ordinary activities after taxation
being retained loss for the period (6,731) (6,909) (13,253)
__________ __________ __________
Loss per share - basic and diluted 4 (5.6p) (5.9p) (11.2p)
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.
Results for the periods ended 31 March 2006 and 30 September 2006 have been
restated to reflect the impact of the adoption of FRS 20. See note 9 for
details.
GW Pharmaceuticals plc
Consolidated balance sheet
As at 31 March 2007 - Unaudited
31 March 31 March 30 September
Notes 2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
Fixed assets
Intangible assets - goodwill 5,031 5,388 5,210
Tangible assets 1,044 681 952
__________ __________ __________
6,075 6,069 6,162
__________ __________ __________
Current assets
Stock 665 617 695
Debtors: amounts falling due within one year 5 3,928 3,549 4,335
Debtors: amounts due after more than one year 5 1,012 901 -
Cash held on deposit as short term investment 8,101 18,092 14,437
Cash at bank and in hand 13,813 7,271 5,438
__________ __________ __________
27,519 30,430 24,905
Creditors: Amounts falling due within one year 6 (6,286) (4,872) (5,403)
__________ __________ __________
Net current assets 21,233 25,558 19,502
__________ __________ __________
Total assets less current liabilities 27,308 31,627 25,664
Creditors: Amounts falling due after one year 6 (18,249) (10,967) (10,567)
Provisions for liabilities and charges (54) (32) (40)
__________ __________ __________
Net assets 9,005 20,628 15,057
__________ __________ __________
Capital and reserves
Called-up share capital 8 120 120 120
Share premium account 8 58,223 58,209 58,210
Other reserves 8 19,262 19,262 19,262
Profit and loss account 8 (68,600) (56,963) (62,535)
__________ __________ __________
Equity shareholders' funds 8 9,005 20,628 15,057
__________ __________ __________
GW Pharmaceuticals plc
Consolidated cash flow statement
For the six months ended 31 March 2007 - Unaudited
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
Net cash flow from operating activities 1,950 4,037 (3,275)
Returns on investment and servicing of finance 357 306 919
Taxation - - 1,678
Capital expenditure (281) (125) (593)
__________ __________ __________
Cash flow before management of liquid resources and 2,026 4,218 (1,271)
financing
Management of liquid resources 6,336 (7,972) (4,317)
Financing 13 8,112 8,113
__________ __________ __________
Increase in cash during the period 8,375 4,358 2,525
__________ __________ __________
Reconciliation of operating loss to net cash flow from operating activities
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Restated Restated
Unaudited Unaudited Audited
#000's #000's #000's
Operating loss (8,136) (8,236) (16,204)
Depreciation charge 189 167 364
Amortisation of goodwill 178 178 356
Decrease / (increase) in stocks 30 39 (39)
Decrease / (increase) in debtors 444 (1,294) (1,846)
Increase in creditors 8,579 12,470 12,609
All employee share scheme charge - - 147
Share-based payment charge 666 713 1,338
__________ __________ __________
Net cash flow from operating activities 1,950 4,037 (3,275)
__________ __________ __________
GW Pharmaceuticals plc
Notes
1 Basis of preparation
These interim statements have been prepared on a consistent basis with the
financial statements for the year ended 30 September 2006 except for the
adoption of FRS 20 (Share-based payment). The Group has applied the
requirements of FRS 20 (Share-based payment), in accordance with the
transitional provisions to all equity instruments granted after 7 November
2002 and unvested at 1 October 2006 (see note 9).
These interim statements do not constitute statutory financial statements
within the meaning of Section 240 of the Companies Act 1985. Results for
the six month periods ended 31 March 2007 and 31 March 2006 have not been
audited. The results for the year ended 30 September 2006 have been
extracted from the statutory financial statements that have been filed
with the Registrar of Companies subject to the prior year adjustment
described in note 9. The auditors' report on those financial statements was
unqualified.
2 Segmental Information
Turnover:
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
Product sales 423 501 1,348
Licensing fees 400 232 633
__________ __________ __________
823 733 1,981
__________ __________ __________
Geographical analysis of turnover:
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000s
UK 268 112 338
Europe (excluding UK) 400 544 1,426
North America 155 77 217
__________ __________ __________
823 733 1,981
__________ __________ __________
3 Tax credit on loss on ordinary activities
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
UK Corporation tax - R&D tax credit:
Current period (1,012) (901) (2,022)
__________ __________ __________
The UK Corporation tax credits relate to research and development expenditure
claimed under the Finance Act 2000.
The amounts are subject to the agreement of HM Revenue and Customs.
4 Loss per share
The calculations of loss per share are based on the following losses and
numbers of shares.
Six months ended Six months ended Year ended
31 March 31 March 30 September
2007 2006 2006
Restated Restated
Unaudited Unaudited Audited
#000's #000's #000's
Loss for the financial period (6,731) (6,909) (13,253)
___________ ___________ ___________
Number of shares Number of shares Number of shares
Weighted average number of shares 120,085,006 116,802,886 118,443,944
___________ ___________ ___________
Since the Group reported a net loss, diluted loss per share is equal to basic
loss per share.
5 Debtors
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
Amounts falling due within one year
Trade debtors 67 67 579
Taxation recoverable - UK Corporation tax 2,022 1,678 2,022
Taxation recoverable - foreign withholding tax 1,200 1,200 1,200
Other debtors 449 351 285
Prepayments an accrued income 190 253 249
__________ __________ __________
3,928 3,549 4,335
__________ __________ __________
Amounts falling due after one year
Taxation recoverable - UK Corporation tax 1,012 901 -
__________ __________ __________
Foreign Withholding tax relates to a 10% Spanish withholding tax on the #12m
Almirall signature fee.
6 Creditors
31 March 31 March 30 September
2007 2006 2006
Unaudited Unaudited Audited
#000's #000's #000's
Amounts falling due within one year
Trade creditors 2,225 1,967 2,527
Other taxation and social security 169 151 155
Accruals 1,930 1,894 1,834
Deferred income 1,900 800 800
Defined contribution pension scheme accruals 62 60 37
Other creditors - - 50
__________ __________ __________
6,286 4,872 5,403
__________ __________ __________
Amounts falling due after one year
Deferred income 18,249 10,967 10,567
__________ __________ __________
Deferred income represents the balance of the non-refundable signature fees
received from Almirall and Otsuka. These amounts will be recognised as revenue
in future periods.
For Almirall the #12m signature fee is being recognised at the rate of #0.8m per
year over 15 years from December 2005. In the case of Otsuka, where the Group's
obligations under the agreement are weighted towards the earlier years, the $18m
(#9.2m) signature fee will be recognised from 1 April 2007 to 30 September 2011
at the rate of #1.1m per year and at #0.28m per year for the following 15 years.
7 Analysis of changes in net funds
As at As at
30 September 2006 Cashflow 31 March 2007
Audited Unaudited Unaudited
#000's #000's #000's
Cash held on deposit as short term investment 14,437 (6,336) 8,101
Cash at bank and in hand 5,438 8,375 13,813
__________ __________ __________
19,875 2,039 21,914
__________ __________ __________
8 Movement in Share Capital & Reserves
Called-up Called-up Share
share share premium
capital capital account
Unaudited Unaudited Unaudited
Group No. of shares #000's #000's
At 1 October 2006 120,076,035 120 58,210
Exercise of share options 20,300 - 13
Share-based payment - - -
Retained loss for the period - - -
___________ __________ __________
At 31 March 2007 120,096,335 120 58,223
___________ _________ __________
Movement in Share Capital & Reserves (continued from table above)
Other Profit and
reserves loss account Total
Unaudited Unaudited Unaudited
Group #000's #000's #000's
At 1 October 2006 19,262 (62,535) 15,057
Exercise of share options - - 13
Share-based payment - 666 666
Retained loss for the period - (6,731) (6,731)
_________ __________ _________
At 31 March 2007 19,262 (68,600) 9,005
_________ __________ _________
9 FRS 20 (Share-based payment)
The Group adopted FRS 20 (Share-based payment) in the period.
The Group provides benefits to employees (including Directors) in the form
of share-based payment transactions, whereby employees render services in
exchange for rights over shares ('equity-settled transactions'). The fair
value of the employee services rendered is determined by reference to the
fair value of the options granted.
All share options are valued using an option-pricing model (Black-Scholes).
This fair value is charged to the profit and loss account over the vesting
period of the share-based payment scheme. The value of the charge is
adjusted in the profit and loss account over the remainder of the vesting
period to reflect expected and actual levels of options vesting.
The adoption of FRS 20 has resulted in a change in accounting policy for
share-based payments. A prior year adjustment has been made to the
financial information set out for the period to 31 March 2006 and
30 September 2006 to apply charges to the profit and loss account for share
options granted.
The Group has recognised a total expense of #666,000 relating to equity
settled share option scheme transactions in the six month period to
31 March 2007 (#713,000 in the six month period to 31 March 2006;
#1,338,000 in the year to 30 September 2006).
10 Availability of Information
A copy of this statement is available from the registered office of the
Company.
This information is provided by RNS
The company news service from the London Stock Exchange
END
IR SFEFMASWSEEM
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