TIDMNPH
RNS Number : 9248Z
Neuropharm Group PLC
30 September 2009
+-----------------------------------------------------------+-------------------+
| For immediate release | 30 September 2009 |
+-----------------------------------------------------------+-------------------+
Neuropharm Group plc
("Neuropharm" or "the Company")
Preliminary results for the year ended 30 June 2009
Neuropharm Group plc (AIM: NPH), a speciality pharmaceutical company focused on
neurodevelopmental disorders, announces its preliminary results for the year
ended 30 June 2009.
Key points
* Discussions ongoing regarding potential collaboration on further development and
commercialisation of NPL-2008 in Autistic Disorder
* Pipeline expanded with two new near-term revenue-generating opportunities
- NPL-2505, a branded pharmaceutical targeting a substantial patient population
- NPL-2510, a novel biological screen for autism
* Positive Phase IIa results from NPL-2009 and NPL-2005 have placed Neuropharm at
the forefront of Fragile X Syndrome research
* Patent filing in connection with NPL-2003 in Obsessive Compulsive Disorder,
focused on the treatment of child-onset OCD
* Cash, cash equivalents and money market investments at 30 June 2009 of GBP7.0
million (2008: GBP12.7 million)
For further information please contact:
+-------------------------------------------+-----------------------+
| Neuropharm | + 44 (0) 1372 371 171 |
+-------------------------------------------+-----------------------+
| Robert Mansfield, Chief Executive Officer | |
| Graham Yeatman, Chief Financial Officer | |
+-------------------------------------------+-----------------------+
| | |
+-------------------------------------------+-----------------------+
| Piper Jaffray Limited | + 44 (0) 203 142 8700 |
+-------------------------------------------+-----------------------+
| Neil Mackison, Rupert Winckler | |
+-------------------------------------------+-----------------------+
| | |
+-------------------------------------------+-----------------------+
| Buchanan Communications | + 44 (0) 207 466 5000 |
+-------------------------------------------+-----------------------+
| Mark Court, Catherine Breen | |
+-------------------------------------------+-----------------------+
Notes to Editors:
About Neuropharm
Neuropharm is a speciality pharmaceutical company focused on the development of
products for the treatment and management of neurodevelopmental disorders.
Please visit www.neuropharm.co.uk for further information.
JOINT STATEMENT FROM THE CHAIRMAN AND CHIEF EXECUTIVE OFFICER
We announce our preliminary results for the year ended 30 June 2009 and provide
an update on progress to date.
At the start of the 2009 financial year we were focused on the completion of the
Phase III SOFIA study of NPL-2008 in the treatment of Autistic Disorder. This
was a major study carried out in the US in collaboration with Autism Speaks, the
US patient organisation, and included more than 150 patients at specialist
centres.
We were disappointed to announce in February 2009 that the SOFIA study had not
met its primary endpoint of providing a statistically significant reduction in
repetitive behaviours in patients with Autistic Disorder. The SOFIA study showed
that repetitive behaviours were reduced both by NPL-2008 and by placebo. This
positive placebo response was unexpected, as two previous studies of the active
ingredient of NPL-2008 had shown a positive effect of treatment in the absence
of any placebo effect.
We have undertaken a detailed analysis of the SOFIA data to gain a better
understanding of the study results. We have investigated the extent to which
placebo effects can impact clinical studies in Autistic Disorder and have worked
with clinicians and regulatory experts to understand this unexpected effect.
This analysis has led us to conclude that NPL-2008 merits further study in the
treatment of Autistic Disorder and that the compound retains the potential to be
the world's first licensed therapy for this indication. Our view on the
potential of NPL-2008 is supported by clinicians, academics and other experts in
the field of Autistic Disorder whose advice we have taken.
We are well advanced in planning the design of a second Phase III study, which
would have important differences to the SOFIA study and which we estimate would
cost approximately GBP5 million to complete. The second Phase III study would
employ a specific design to mitigate the placebo effect seen in the SOFIA study
and would also include changes to the dosing regimen.
As we do not currently have the financial resources to carry out a further Phase
III study we have put further project expenditure on NPL-2008 on hold whilst we
assess the funding alternatives. Discussions are ongoing regarding potential
collaboration on the further development and commercialisation of the product,
after initial exclusive negotiations on a North American deal were terminated.
Changes to the arrangements with Mount Sinai School of Medicine have been agreed
and discussions with Catalent on the arrangements for the future are at an
advanced stage.
Whilst much of our effort during the year has been directed towards NPL-2008, we
have also made significant advances on other projects in our pipeline. The
Company is now focusing on two new near-term revenue-generating opportunities,
NPL-2505 and NPL-2510, both of which are global opportunities and could be
funded over the next financial year from existing resources. NPL-2505 is a
branded pharmaceutical and NPL-2510 is a biological screen for autism.
Following the outcome of the SOFIA study, we acted promptly to implement a cost
reduction programme in the UK and the US and, as a result, at 30 June 2009 we
had cash, cash equivalents and money market investments of GBP7.0 million. The
Company is also preparing grant applications for external funding of anticipated
future projects.
NPL-2505
This programme involves a new formulation of an existing marketed compound
targeting an opportunity associated with unmet need in substantial patient
populations, identified during the recent interactions with psychiatrists,
neurologists and regulators. In contrast to NPL-2008, the technical and
commercial issues with this product are minimal. On present plans, working
closely with Catalent, the programme is set for submission of a New Drug
Application ("NDA") in the US in 2011. This low-cost programme represents an
opportunity for the Company to bring the product to market in the US using
non-sales force promotion targeting specialist physicians. The product could be
partnered in other non-US markets.
NPL-2510: Autism Screen
The Company has an exclusive option to negotiate a licence for proprietary
technology on a novel biological screen for autism in infants, children and
adults. The university group that developed the screen has already conducted
work showing the potential of the results from the screen, which identifies
specific markers for autism. Further validation work is planned in the US and
Europe to prepare the product for launch by 2012.
This screen represents an exciting near-term global opportunity with significant
market potential in a favourable regulatory environment, which the Company could
fund over the next financial year from existing resources. This low-cost
programme is a second opportunity for the Company to introduce a product
targeting specialist physicians using non-sales force promotion.
NPL-2008: Autistic Disorder
On 18 February 2009 we announced that the SOFIA study had not met its primary
endpoint of a statistical reduction in repetitive behaviours and that, compared
with the previously successful trial, the results were both unexpected and
disappointing. Unlike other SSRIs in paediatric studies in autism, NPL-2008 was
well tolerated by patients in the SOFIA study and no serious adverse events were
reported. NPL-2008 and placebo conferred benefit in the SOFIA study, with both
treatments reducing repetitive behaviours in patients, according to the response
criterion of a 25 percent reduction in CYBOCS-PDD. In the SOFIA study the
placebo effect was markedly higher than in the Mount Sinai study and,
accordingly, no statistically significant difference was observed on the primary
endpoint between the active and placebo treatment groups. The follow-on EMMA
study, offered to patients who had participated in SOFIA, was wound down with
considerable cost savings.
We undertook a detailed analysis and review of the SOFIA data, which has
convinced us that modifications to the design of the study are required to take
into account the positive placebo response, which has also been observed with
other compounds in psychiatric and neurology studies.
We are now at an advanced stage in planning a further Phase III study, which
would employ a modified design and would enrol a similar number of patients to
the SOFIA study. The design for this study has been evolved in consultation with
independent advisers and potential partners and is designed to mitigate the
placebo effect seen in SOFIA.
In addition, our analysis of the SOFIA data suggests that the placebo effect
seen impacted the dose titration executed in the study, to the extent that the
doses required to demonstrate clinical effect may not have been reached. Since a
higher dosage of NPL-2008 could be of benefit, we would propose to include
higher dosages in a second Phase III study design. These proposed dosages are
within the FDA's existing approved dose range for fluoxetine for use in children
and adolescents.
It is estimated that a second Phase III study would cost approximately GBP5
million over a two year period. Assuming the successful completion of a second
Phase III study and subsequent approval by FDA, we project that NPL-2008 could
be ready for launch in the US as an orphan drug for the treatment of a core
symptom of Autistic Disorder in 2012.
The low starting dose approach with fluoxetine continues to be endorsed by Mount
Sinai School of Medicine and Great Ormond Street Hospital.
NPL-2005 & NPL-2009: Fragile X Syndrome
We reported significant progress during the period in our two programmes in
Fragile X Syndrome, a condition caused by a mutation in the X chromosome that
affects approximately 1 in every 3,800 male children and approximately 1 in
every 8,000 female children. In Fragile X Syndrome the FMR1 gene on the
affected part of the chromosome shuts down and is unable to produce a protein
needed by the brain for normal brain functioning. The condition, thought to be
the most common cause of inherited intellectual disability, is the focus of
considerable interest from medical, scientific and patient communities because
the genetics and proteomics of the condition are fully understood, suggesting
that successful treatment should be achievable.
Neuropharm has Orphan Drug Designation from FDA's Office of Orphan Product
Development for its two potentially complementary programmes in Fragile X,
NPL-2005 and NPL-2009. At the National Fragile X Foundation's 11th International
Fragile X Conference in St Louis, Missouri, in July 2008, positive results were
presented from Phase IIa studies of both compounds.
The positive results from the Phase IIa study of NPL-2009, which is based on the
existing mGluR5 antagonist fenobam, were later published in the peer-reviewed
Journal of Medical Genetics at the beginning of 2009. The results are believed
to mark the first time that the effects of a potential targeted treatment have
been reported in patients with Fragile X Syndrome. The data obtained from this
study suggested that NPL-2009 was well tolerated after an initial dose and that
a positive effect was seen on a surrogate assessment of brain function.
We have since been working on improving the formulation of the compound to
improve the levels of NPL-2009 in plasma as pharmacokinetic analysis had shown
that NPL-2009 plasma levels were dose dependent but variable.
The results of the fenobam Phase IIa study have prompted considerable interest
and placed Neuropharm in at the forefront of Fragile X Syndrome research.
The clinical investigators in the study of NPL-2005, which is based on the
existing anti-convulsant compound valproate, concluded that the compound could
be effective in the treatment of Attention Deficit Hyperactivity Disorder (ADHD)
(behavioural) like symptoms in young males with Fragile X Syndrome.
NPL-2003: Obsessive Compulsive Disorder
NPL-2003 is an existing marketed product that the Company believes could be of
benefit to children and some adults with Obsessive Compulsive Disorder (OCD).
Patients with OCD display two principal features: repeated (obsessional)
thoughts of a severely anxious nature and, in an attempt to reverse the
obsessional anxieties, repeated ineffectual (compulsive) behaviour or thoughts,
such as repeated hand-washing. Depression, social phobia and substance abuse
rates are higher in these patients than in the general population.
There are a number of different types of OCD, some of which occur for the first
time in adults and others that are characterised as having an onset in
childhood.
Two small, open-label Phase II studies of NPL-2003 have been carried out in the
US through our collaborations with Columbia University, New York, and
University Hospitals Case Medical Center at Case Western Reserve University
School of Medicine, Cleveland.
The first study was a paediatric study of six patients at Columbia University;
the second study comprised an adult population of 15 patients and was conducted
by both Columbia University and Case Western.
The combined data from the studies suggest that NPL-2003 demonstrates
therapeutic benefit in patients whose OCD started in childhood, irrespective of
their age during treatment. The data from the adult study suggest that NPL-2003
does not show benefit in patients whose OCD starts in adulthood. The results of
the two studies are close to publication. The Company has filed a patent
application.
The investigators in the studies believe that the data are compatible with the
hypothesis that oxidative stress could be involved in the onset of OCD in
children. Oxidative stress is caused by an over-production of free radicals
during cellular metabolism.
Outlook
Our detailed analysis of the data from the SOFIA trial indicates that NPL-2008
retains the potential to be the world's first licensed therapy for Autistic
Disorder. We are therefore well advanced in planning the design of a second
Phase III study, which would cost approximately GBP5 million to complete.
Project expenditure on NPL-2008 is on hold as we continue in partnering
discussions and assess the alternatives for funding the study.
Our two new near-term programmes in NPL-2505 and NPL-2510 could both be funded
over the next financial year from existing resources and represent attractive
opportunities for revenue generation in the US market and potential licensing
and partnering in other markets.
We reported cash, cash equivalents and money market investments of GBP7.0
million at the year end and will continue to manage resources carefully, whilst
continuing to progress our pipeline of product opportunities.
Graeme M. HartRobert G. Mansfield
Chairman Chief Executive Officer
29 September 2009
FINANCIAL REVIEW
The financial statements for the year ended 30 June 2009 are presented in
accordance with the Group's accounting policies based on International Financial
Reporting Standards ("IFRS") as adopted by the European Union.
Cash, cash equivalents and money market investments at 30 June 2009 totalled
GBP7.0 million (2008: GBP12.7 million).
Results of operations
We report a loss after tax of GBP5.9 million for the year ended 30 June 2009
(2008: GBP4.2 million), which is to be set against reserves. The Directors do
not recommend the payment of a dividend (2008: GBPnil).
Our virtual model enables us to have a low fixed cost base and keep variable
costs tightly controlled, with decisions regarding investment in our pipeline
and development of our US organisation dependent on regular review by the
Directors. We ensured that the committed costs of our US organisation and
pre-launch marketing of NPL-2008, were kept to a minimum awaiting the result of
the SOFIA study in February 2009. Following the outcome of the SOFIA study, we
acted promptly to implement a cost reduction programme. This approach has given
us increased control over our cash-burn which has enabled us to preserve our
cash balance.
Research and development expenses
Research and development expenses are primarily in respect of undertaking
clinical trials and use of consultants for regulatory advice, market research
and supply chain consultancy.
Research and development expenses were GBP3.5 million this year (2008: GBP3.0
million), of which GBP3.2 million was in respect of our lead programme NPL-2008
(2008: GBP2.4 million) and within this GBP1.9 million was attributable to SOFIA,
GBP0.6 million to EMMA, GBP0.3 million to bioequivalence studies, GBP0.3 million
to regulatory work and GBP0.1 million to other consultancy.
Selling, marketing and distribution expenses
Selling, marketing and distribution expenses were GBP0.5 million (2008: GBP0.1
million). These consist primarily of consultancy fees for market research, brand
identity and launch planning strategy invested in initial preparations for the
pre-launch marketing of NPL-2008.
Other management and administration expenses
Other management and administration expenses were GBP3.2 million (2008: GBP2.6
million). These consist primarily of remuneration for UK and US employees, rent,
travel and expenses, professional fees for legal, tax and audit services, and
fees for Non-Executive Directors.
Share option expense
A share option expense of GBP0.4 million has been charged for the year (2008:
GBP0.1 million).
Impairment charge
An impairment charge of GBP0.2 million has been charged for the year (2008:
GBPnil) as a result of the Directors decision to impair in full the value of the
intangible asset and tooling pending the outcome of partnering discussions and
assessment of alternatives for funding NPL-2008.
Investment income
The Company invests its surplus funds in bank deposits and money market
investments of up to one year, according to the terms of the Group's Treasury
Policy. In the year ended 30 June 2009 interest receivable was GBP0.4 million
(2008: GBP0.9 million), in line with the decrease in surplus funds during the
course of the year and the decline in the interest rates commercially available.
FINANCIAL REVIEW (continued)
Taxation
The Group makes claims each year for Research and Development Tax Credits and,
as it is loss-making, elects to surrender these tax credits for a cash rebate.
The amount credited to the consolidated income statement in respect of amounts
receivable for the surrender of research and development expenditure is GBP0.6
million for the year ended 30 June 2009 (2008: GBP0.8 million).
Liquidity, cash and cash equivalents, and money market investments
The net cash used in operating activities was GBP6.8 million (2008: GBP5.7
million).
Accrued income and margin deposits at 30 June 2009 were GBP0.1 million (2008:
GBP0.5 million). The decrease is mainly due to the Company's decision to
shorten maturity dates for term deposits to less than three months. There was no
hedging of foreign currency exposure through forward foreign exchange contracts
and, therefore, no margin deposits at the year end.
Trade and other receivables at 30 June 2009 were GBP0.1 million (2008: GBP0.2
million).
Trade and other payables at 30 June 2009 were GBP0.6 million (2008: GBP1.3
million), primarily due to the retrenchment of spend following the result of the
SOFIA study and the Company's decision not to award bonuses to employees for the
year ended 30 June 2009.
Going concern
As disclosed in note 2 to the consolidated financial information, having made
relevant and appropriate enquiries, including consideration of the Group's
current cash resources and cash flow forecasts, the Board has a reasonable
expectation that, at the time of approving the financial statements, the Group
has adequate resources to continue in operational existence for at least the
next 12 months. Accordingly, the Board continues to adopt the going concern
basis in preparing the financial statements.
Graham E. Yeatman
Chief Financial Officer
29 September 2009
CONSOLIDATED INCOME STATEMENT
Year ended 30 June 2009
+----------------------------------------+------+----+----------+----------+----------+
| | Note | | | 2009 | 2008 |
| | | | | GBP'000 | GBP'000 |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Research and development | | | | (3,472) | (3,000) |
| expenses | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Selling, marketing and | | | | (454) | (132) |
| distribution expenses | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Other management and | | | | (3,167) | (2,605) |
| administration expenses | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Movement on provision for | | | | 97 | 4 |
| National Insurance on share | | | | | |
| option gains | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Share option expense | | | | (450) | (147) |
+----------------------------------------+------+----+----------+----------+----------+
| Impairment charge | | | | (189) | - |
+----------------------------------------+------+----+----------+----------+----------+
| Total management and | | | | (3,709) | (2,748) |
| administration expenses | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Operating loss | | | | (7,635) | (5,880) |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Investment income | | | | 442 | 881 |
+----------------------------------------+------+----+----------+----------+----------+
| Other gains and losses | | | | 693 | 54 |
+----------------------------------------+------+----+----------+----------+----------+
| Loss on ordinary activities | | | | (6,500) | (4,945) |
| before tax | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Taxation | | | | 616 | 754 |
+----------------------------------------+------+----+----------+----------+----------+
| Loss for the year | | | | (5,884) | (4,191) |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Loss per share | | | | | |
+----------------------------------------+------+----+----------+----------+----------+
| Basic and diluted | 3 | | | (18.7)p | (13.3)p |
+----------------------------------------+------+----+----------+----------+----------+
All results derive from continuing operations.
CONSOLIDATED STATEMENT OF CHANGES IN EQUITY
Year ended 30 June 2009
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| | Called | Share | | Foreign | Share-based | Retained | Total |
| | up share | premium | Other | currency | compensation | loss | GBP000 |
| | capital | account | reserve | translation | GBP000 | GBP000 | |
| | GBP000 | GBP000 | GBP000 | reserve | | | |
| | | | | GBP000 | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Balance as at 30 June | 3,154 | 17,313 | (651) | - | 485 | (3,599) | 16,702 |
| 2007 | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Share option expense | - | - | - | - | 147 | - | 147 |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Reserve transfer | - | (44) | 44 | - | - | - | - |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Loss for the year | - | - | - | - | - | (4,191) | (4,191) |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Balance as at 30 June | 3,154 | 17,269 | (607) | - | 632 | (7,790) | 12,658 |
| 2008 | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Share option expense | - | - | - | - | 450 | - | 450 |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Foreign exchange | - | - | - | 33 | - | - | 33 |
| adjustments on | | | | | | | |
| consolidation | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Loss for the year | - | - | - | - | - | (5,884) | (5,884) |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
| Balance as at 30 June | 3,154 | 17,269 | (607) | 33 | 1,082 | (13,674) | 7,257 |
| 2009 | | | | | | | |
+---------------------------+----------+-----------+-----------+-------------+------------------+-----------+-----------+
CONSOLIDATED BALANCE SHEET
30 June 2009
+--------------------------------------+------+-------+----------+----------+----------+
| | Note | | | 2009 | 2008 |
| | | | | GBP'000 | GBP'000 |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Non-current assets | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Intangible assets | | | | - | 42 |
+--------------------------------------+------+-------+----------+----------+----------+
| Property, plant and equipment | | | | 16 | 181 |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | 16 | 223 |
+--------------------------------------+------+-------+----------+----------+----------+
| Current assets | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Accrued income and margin | | | | 63 | 472 |
| deposits | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Trade and other receivables | | | | 95 | 232 |
+--------------------------------------+------+-------+----------+----------+----------+
| Research and development tax | | | | 600 | 500 |
| credit receivable | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Derivative financial | | | | - | 2 |
| instruments | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Money market investments | | | | 1,000 | 9,510 |
+--------------------------------------+------+-------+----------+----------+----------+
| Cash and cash equivalents | | | | 6,037 | 3,148 |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | 7,795 | 13,864 |
+--------------------------------------+------+-------+----------+----------+----------+
| Current liabilities | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Trade and other payables | | | | (554) | (1,332) |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Net current assets | | | | 7,241 | 12,532 |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Total assets less current | | | | 7,257 | 12,755 |
| liabilities | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Non-current liabilities | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Long-term provisions | | | | - | (97) |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Net assets | | | | 7,257 | 12,658 |
+--------------------------------------+------+-------+----------+----------+----------+
| | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Equity | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Share capital | 4 | | | 3,154 | 3,154 |
+--------------------------------------+------+-------+----------+----------+----------+
| Share premium account | | | | 17,269 | 17,269 |
+--------------------------------------+------+-------+----------+----------+----------+
| Other reserve | | | | (607) | (607) |
+--------------------------------------+------+-------+----------+----------+----------+
| Foreign currency translation | | | | 33 | - |
| reserve | | | | | |
+--------------------------------------+------+-------+----------+----------+----------+
| Retained loss | | | | (13,674) | (7,790) |
+--------------------------------------+------+-------+----------+----------+----------+
| Share-based compensation | | | | 1,082 | 632 |
+--------------------------------------+------+-------+----------+----------+----------+
| Total equity | | | | 7,257 | 12,658 |
+--------------------------------------+------+-------+----------+----------+----------+
CONSOLIDATED CASH FLOW STATEMENT
Year ended 30 June 2009
+---------------------------------------------+------+----------+----------+----------+
| | Note | | 2009 | 2008 |
| | | | GBP'000 | GBP'000 |
+---------------------------------------------+------+----------+----------+----------+
| | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Net cash used in operating | 5 | | (6,777) | (5,743) |
| activities | | | | |
+---------------------------------------------+------+----------+----------+----------+
| | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Investing activities | | | | |
+---------------------------------------------+------+----------+----------+----------+
| | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Interest received | | | 442 | 881 |
+---------------------------------------------+------+----------+----------+----------+
| Sales of money market investments | | | 8,510 | 2,495 |
+---------------------------------------------+------+----------+----------+----------+
| Purchases of property, plant and | | | (12) | (185) |
| equipment | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Net cash from investing activities | | | 8,940 | 3,191 |
+---------------------------------------------+------+----------+----------+----------+
| | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Net increase / (decrease) in cash | | | 2,163 | (2,552) |
| and cash equivalents | | | | |
+---------------------------------------------+------+----------+----------+----------+
| | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Cash and cash equivalents at | | | 3,148 | 5,646 |
| beginning of year | | | | |
+---------------------------------------------+------+----------+----------+----------+
| Effect of foreign exchange rate | | | 726 | 54 |
| changes | | | | |
+---------------------------------------------+------+----------+----------+----------+
| | | |
+---------------------------------------------+------+----------+
| Cash and cash equivalents at end of | | | 6,037 | 3,148 |
| year | | | | |
+---------------------------------------------+------+----------+----------+----------+
NOTES TO THE CONSOLIDATED FINANCIAL INFORMATION
Year ended 30 June 2009
1. GENERAL INFORMATION
The financial information in this preliminary statement does not constitute
statutory accounts as defined in section 435 of the Companies Act 2006. The
information has been extracted from the consolidated financial statements for
the years ended 30 June 2009 and 30 June 2008. The statutory accounts of
Neuropharm Group plc for the year ended 30 June 2008 have been delivered to the
Registrar of Companies and those for the year ended 30 June 2009 will be
delivered following the Company's Annual General Meeting. The Auditors have
reported on those financial statements and their reports were (i) unqualified,
(ii) did not draw attention to any matters by way of emphasis, and (iii) did not
contain any statements under section 237 (2) or (3) of the Companies Act 1985 in
respect of the financial statements for 2008 nor a statement under section 498
(2) or (3) of the Companies Act 2006 in respect of the financial statements for
2009.
Whilst the financial information included in this preliminary statement has been
prepared in accordance with International Financial Reporting Standards (IFRSs)
as endorsed by the European Union, this statement does not itself contain
sufficient information to comply with IFRSs.
The Group's principal accounting policies are unchanged compared to the year
ended 30 June 2008 and there have been no new accounting standards during the
year that have significantly impacted the results of the Group.
2. SIGNIFICANT ACCOUNTING POLICIES
Going concern
In determining the appropriate basis of preparation of the financial statements,
the Directors are required to consider whether the Group can continue in
operational existence for the foreseeable future, being a period of not less
than twelve months from the date of the approval of the financial statements.
During the year ended 30 June 2009, there was a continuing focus on the
management of costs within the Group. As at 30 June 2009, the Group had cash,
cash equivalents and money market investments of GBP7.0 million, and the Group
had net assets of GBP7.3 million. Management prepares detailed cash flow
forecasts which are reviewed by the Board on a regular basis. The forecasts
include assumptions regarding future income and expenditure together with
various scenarios which reflect opportunities, risks and appropriate mitigating
actions.
Whilst there are inherent uncertainties regarding the cash flows associated with
product development and future commercialisation, together with the partnering
discussions and alternatives for funding discussed in the Joint Statement from
the Chairman and Chief Executive Officer, the Directors are satisfied that there
is sufficient discretion and control as to the timing and quantum of cash
outflows to ensure that the Group is able to meet its liabilities as they fall
due for at least the next 12 months. Therefore, having made relevant and
appropriate enquiries, including consideration of the Group's current cash
resources and the cash flow forecasts, the Board has a reasonable expectation
that, at the time of approving the financial statements, the Group has adequate
resources to continue in operational existence for at least the next 12 months.
Accordingly, the Board continues to adopt the going concern basis in preparing
the financial statements.
This preliminary statement was approved by the Board on 29 September 2009.
NOTES TO THE CONSOLIDATED FINANCIAL INFORMATION (continued)
Year ended 30 June 2009
3. LOSS PER SHARE
As at the year end there were outstanding options over 4,784,948 ordinary shares
(2008: 5,432,011 ordinary shares) in the Company.
IAS 33 "Earnings per Share" requires presentation of diluted earnings per share
when a company could be called upon to issue shares that would decrease net
profit or increase net loss per share. Only options that are 'in the money' are
treated as dilutive and net loss per share would not be increased by the
exercise of these options. Therefore no adjustment has been made to dilute loss
per share for any outstanding share options.
The calculation of the basic and diluted loss per share is based on the
following data:
+----------------------------------------------+----------+------------+------------+
| | | 2009 | 2008 |
| | | GBP'000 | GBP'000 |
+----------------------------------------------+----------+------------+------------+
| Loss | | | |
+----------------------------------------------+----------+------------+------------+
| Loss for the purposes of basic and diluted loss per | 5,884 | 4,191 |
| share being net loss attributable to equity holders of | | |
| the parent | | |
+---------------------------------------------------------+------------+------------+
| | | | |
+----------------------------------------------+----------+------------+------------+
| | | Number | Number |
+----------------------------------------------+----------+------------+------------+
| Number of shares | | | |
+----------------------------------------------+----------+------------+------------+
| Weighted average number of ordinary shares for the | 31,536,697 | 31,536,697 |
| purposes of the basic and diluted loss per share | | |
+----------------------------------------------+----------+------------+------------+
4. SHARE CAPITAL
The Company has one class of ordinary share which carries no right to fixed
income.
+----------------------------------------------+----------+----------+----------+
| | | 2009 | 2008 |
| | | GBP'000 | GBP'000 |
+----------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------+----------+----------+----------+
| Authorised | | | |
+----------------------------------------------+----------+----------+----------+
| 50,000,000 ordinary shares of GBP0.10 | | 5,000 | 5,000 |
| each | | | |
+----------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------+----------+----------+----------+
| Called up, allotted and fully paid | | | |
+----------------------------------------------+----------+----------+----------+
| 31,536,697 ordinary shares of GBP0.10 | | 3,154 | 3,154 |
| each | | | |
+----------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------+----------+----------+----------+
NOTES TO THE CONSOLIDATED FINANCIAL INFORMATION (continued)
Year ended 30 June 2009
5. NOTES TO THE CASH FLOW STATEMENT
+----------------------------------------------------------------+----------+----------+----------+
| | | 2009 | 2008 |
| | | GBP'000 | GBP'000 |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Operating loss | | (7,635) | (5,880) |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Adjustments | | | |
| for: | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Amortisation | | 2 | 5 |
| of | | | |
| intangible | | | |
| assets | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Impairment | | 40 | - |
| of | | | |
| intangible | | | |
| assets | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Depreciation | | 28 | 16 |
| of property, | | | |
| plant and | | | |
| equipment | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Impairment | | 149 | - |
| of | | | |
| property, | | | |
| plant and | | | |
| equipment | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Share | | 450 | 147 |
| option | | | |
| expense | | | |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Operating cash | | (6,966) | (5,712) |
| flows before | | | |
| movements in | | | |
| working | | | |
| capital | | | |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Decrease | | 446 | (246) |
| / | | | |
| (increase) | | | |
| in | | | |
| receivables | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Decrease | | (875) | (21) |
| in | | | |
| payables | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Decrease | | 2 | (24) |
| / | | | |
| (increase) | | | |
| in | | | |
| derivative | | | |
| financial | | | |
| investments | | | |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Net cash used | | (7,393) | (6,003) |
| in operations | | | |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Research and | | 616 | 260 |
| development | | | |
| tax credit | | | |
| received | | | |
+----------------------------------------------------------------+----------+----------+----------+
| | | | |
+----------------------------------------------------------------+----------+----------+----------+
| Net cash used | | (6,777) | (5,743) |
| in operating | | | |
| activities | | | |
+----------------------------------------------------------------+----------+----------+----------+
Cash and cash equivalents (which are presented as a single class of assets on
the face of the balance sheet) comprise cash at bank and other short-term highly
liquid investments with a maturity of three months or less.
This information is provided by RNS
The company news service from the London Stock Exchange
END
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