TIDMAGI
RNS Number : 4279Z
AGI Therapeutics plc
22 September 2009
AGI Therapeutics
Interim financial results for the six months ended 30 June 2009
New business strategy announced
Dublin, Ireland, 22 September 2009 - AGI Therapeutics plc ("AGI" or "the
Company") (AIM, IEX: AGI), a speciality pharmaceutical development company,
today announces interim financial results for the six months ended 30 June 2009.
The Company also today announces that, following a comprehensive review of
the business by management, it has implemented a revised business strategy which
has been endorsed by the Board.
Financial summary
* Cash and short-term deposits at 30 June 2009 of $15.1 million (31 December 2008:
$23.6.million). Net of short-term liabilities: $12.4 million (31 December 2008:
$21.0 million)
* R&D spend $7.8 million (2008: $8.3 million)
* Loss per ordinary share $0.14 cents (2008: $0.13 cents)
Operational summary
* In May, the top line results of ARDIS1, the Phase III efficacy study of
Rezular(TM) in diarrhea-predominant irritable bowel syndrome (IBS-D), the
Company's lead development programme, were announced
* The study did not show a statistically significant difference between drug and
placebo in the primary endpoint of patient-reported adequate relief of IBS
symptoms
* Statistically significant evidence favouring Rezular treatment was achieved in a
number of secondary endpoints and in particular those relating to GI motility
and diarrhea symptoms as well as quality of life
* In March, positive results in a Phase II proof-of-concept study of AGI-004 in
the control of chemotherapy-induced diarrhea (CID) were announced. AGI-004 is a
once-daily controlled release transdermal patch containing the nicotinic
antagonist mecamylamine
* The results showed a statistically significant difference between drug and
placebo in the primary endpoint of reducing the incidence of patient-recorded
diarrhea
* The primary endpoint was supported by a statistically significant difference in
the secondary endpoint of patient-recorded severity of diarrhea
Business strategy review
Following the announcement on May 15th that AGI was discontinuing the
development of Rezular in the broad indication of IBS-D, the Company commenced a
full review of its business strategy, including a fundamental review of its
pipeline products, and an extensive post-hoc analysis of the data from the ARDIS
1 study and the ARDIS 3 safety study of Rezular. That business review has now
been completed and a new business strategy, prepared by management, has been
approved by AGI's Board of Directors.
The key elements of the new business strategy are as follows:
Business focus
* While AGI has focused to date on products for gastro-intestinal (GI)
indications, the Company's approach to development of differentiated products
based on Known Molecular Entities (KMEs) is equally applicable to other
therapeutic areas
* Under the new business plan, the Company will focus on the development of
specialty products where there is an unmet medical need. In some cases these
products will be developed for Orphan indications
* The Company will focus its primary efforts on the US market where it has the
most experience and which offers the greatest commercial potential
* By focusing on products targeting unmet medical needs in specialty indications
the Company will execute development programmes in a timely and cost effective
manner and will aim to bring products to the market either directly or through
out-licensing to or partnering with established pharmaceutical companies
* The Company's immediate focus will be to maximize the value of its existing
pipeline of products, as well as adding new product opportunities where
appropriate
Product pipeline
* Applying criteria based on the new business strategy, AGI has completed a
comprehensive review of its product pipeline and associated indications
* A comprehensive review of the data from ARDIS 1, AGI's Phase III clinical
efficacy study of Rezular in IBS-D, has been conducted. The analysis has
confirmed that Rezular offers a potential treatment for chronic diarrhea
symptoms, particularly those associated with altered gut motility. Furthermore
the analysis, based on extensive and extended drug exposure in ARDIS 1 and ARDIS
3 supports the excellent safety profile of the drug. (A separate press release
setting out in more detail the results of this analysis is issued today.)
* Following the review, AGI has identified a number of potential
diarrhea-associated indications for Rezular that could be appropriate for
further development. Some of these indications may qualify for Orphan drug
status and approval. For competitive and intellectual property protection
reasons, AGI does not intend to reveal these indications until priority has been
established. AGI estimates that if Rezular was ultimately successfully
developed, approved and launched in all these indications, peak sales could be
in excess of $1.0 billion
* In addition, based on the unique pharmacology of Rezular, AGI has identified a
new indication that is not diarrhea-related and is not in the GI therapeutic
area, but which is an established Orphan indication where Rezular may have
particular and unique benefit. If successfully developed in this indication AGI
estimates potential peak global sales of $0.5 billion
* The management team has also determined that AGI-004, transdermal mecamylamine
for the treatment of Chemotherapy Induced Diarrhoea (CID), meets the criteria of
AGI's new business strategy and will be considered for further development
* A detailed operational plan is now being developed around these core products,
Rezular and AGI-004, that prioritises the programmes for further direct
investment by AGI. Co-funding or funding through strategic industry alliances
may be considered for certain programmes
* AGI has three other products in development, AGI-010, AGI-022 and AGI-006. The
Company recently announced that it has reached mutual agreement with Axcan
Pharma Inc. to terminate the joint-development of AGI-010, controlled-release
omeprazole, without any further financial obligations on either party. AGI has
now regained full rights to this product and intends to seek pharmaceutical
partners to fund the further development of AGI-010. A similar approach will be
taken with AGI-022, a targeted and controlled-release aminosalicylate and
AGI-006, an upper-GI prokinetic agent
New products
* In addition to building value based on its core products, Rezular and AGI-004,
the business review has made provision for adding new products to add to the
pipeline, including through partnerships and/or alliances with other companies.
These new opportunities will be evaluated against the same criteria as those
being pursued in-house, i.e. targetting unmet medical needs, in specialist
indications and potential Orphan indications
Cost structure and cash
In the June 11 AGM statement, AGI announced that it expected to have cash
resources of approximately $12.0 million at the end of Q2 2009. Cash on hand at
30 June 2009 was $15.1 million, before current liabilities of $2.7 million, most
of which related to close out costs on the ARDIS programme and restructuring
costs. These liabilities are due to be discharged in the third quarter of 2009,
leaving pro-forma cash reserves of $12.4 million available as of the end of June
for the execution of the new business strategy. The Company has moved to reduce
its cost base which will allow for future clinical programmes to be funded to
ensure it can rebuild value in its pipeline. The Company envisages that it will
have sufficient cash resources for at least two years.
Commenting on the announcement today, John Devane, CEO of AGI stated; "We are
pleased to have completed a rigorous business strategy and portfolio review,
which provides a realistic route for rebuilding value in our pipeline, using the
assets and resources available to us. In recent months we have spent
considerable time identifying assets that will benefit best from further
internal development and those better monetised by out-licensing. Over the next
year we will concentrate our efforts on building value based on clinical and
other scientific evidence in those indications where we see the greatest value
for AGI."
- Ends -
Conference Call:
Please note that AGI will hold a conference call to discuss these results today,
beginning at 11:00 BST.
To participate, please call +353 1 486 0922 (Ireland) or +44 (0) 20 7806
1951(UK) quoting the confirmation code 8869040. A slide presentation
accompanying this call will be available in the Investors/Publications section
of the AGI website 15 minutes before the call commences, or by following this
link:
http://phx.corporate-ir.net/phoenix.zhtml?c=196905&p=irol-reports
Contact Information:
+------------------------------------------+------------------------------------+
| AGI Therapeutics plc. | Tel: +353 1 449 3254 |
+------------------------------------------+------------------------------------+
| David Kelly, Chief Financial Officer | |
+------------------------------------------+------------------------------------+
| | |
+------------------------------------------+------------------------------------+
| Financial Dynamics - UK | Tel: +44 (0) 20 7269 7182 |
+------------------------------------------+------------------------------------+
| Jonathan Birt/John Dineen | |
+------------------------------------------+------------------------------------+
| | |
+------------------------------------------+------------------------------------+
| Financial Dynamics - Ireland | Tel: +353 1 663 3607 |
+------------------------------------------+------------------------------------+
| Niamh Lyons | |
+------------------------------------------+------------------------------------+
| | |
+------------------------------------------+------------------------------------+
| Piper Jaffray Limited | Tel: +44 (0) 20 3142 8700 |
| Neil Mackison | |
| Will Carnwath | |
+------------------------------------------+------------------------------------+
| | |
+------------------------------------------+------------------------------------+
| Davy | Tel: +353 1 614 8761 |
| John Frain | |
+------------------------------------------+------------------------------------+
Notes to Editors:
About Rezular(TM) (AGI-003)
RezularTM (AGI-003) is an orally administered multiple action intestinal
regulator. Rezular contains arverapamil, a single enantiomer moiety of the
racemic drug verapamil.
About AGI Therapeutics plc
AGI is a specialty pharmaceutical company which is focused on the development
and commercialisation of differentiated specialty drug products to treat unmet
medical needs, including conditions which qualify for Orphan drug status.
The Company has a portfolio of product candidates derived from its Known
Molecular Entity (KME(TM)) approach to drug re-profiling and development and
aims to bring its products to the market either directly or through
out-licensing or other partnering arrangements.
AGI's common shares are listed on the Alternative Investment Market of the
London Stock Exchange (AIM) and on the Irish Enterprise Exchange of the Irish
Stock Market (IEX) as AGI.
For further information please see www.agitherapeutics.com.
Statements contained within this press release may contain forward-looking
comments which involve risks and uncertainties that may cause actual results to
vary from those contained in the forward-looking statements. In some cases, you
can identify such forward-looking statements by terminology such as 'may',
'will', 'could', 'forecasts', 'expects', 'plans', 'anticipates', 'believes',
'estimates', 'predicts', 'potential', or 'continue'. Predictions and
forward-looking references in this press release are subject to the satisfactory
progress of research which is, by nature, unpredictable. Forward projections
reflect management's best estimates based on information available at the time
of issue.
Chairman's and Chief Executive's review
The first half of 2009 was dominated by activities associated with progressing
AGI's lead product, Rezular, for the treatment of diarrhoea-predominant
irritable bowel syndrome, (IBS-D). Two Phase III studies, ARDIS 1 and ARDIS 3
were underway during the first half of 2009. ARDIS 1 was a randomised,
double-blind, placebo-controlled, parallel-group, Phase III study in IBS-D
patients (both men and women). There were four treatment arms (placebo and three
dose levels of Rezular) and patients were treated for 12 weeks of double-blind
therapy. A total of 711 patients were randomised in 123 clinical centres in the
United States, Europe and South America. Of the total patients randomised, 63%
were in the United States. ARDIS 3 was an extended safety study, designed to
track at least 100 patients exiting ARDIS 1 for a total exposure of one year on
active drug.
The Company received the top-line results from ARDIS 1 in mid-May. In summary;
* The study did not show statistically significant differences between drug and
placebo in the primary endpoint of patient-reported adequate relief of IBS
symptoms
* Statistically significant evidence favouring Rezular treatment was achieved in a
number of secondary endpoints, particularly those relating to aspects of
diarrhoea e.g. stool form (as assessed by the Bristol Stool Scale), stool
frequency and in the majority of sub-categories of quality-of-life (IBS-QOL)
scores and in the overall IBS-QOL score
* There were no statistically significant differences between treatments in
adequate relief of pain/discomfort or change in severity of pain
* Based on this preliminary data analysis, AGI did not believe that the results of
ARDIS-1 would meet the current regulatory requirements for an effective therapy
for the broad IBS-D population and therefore ceased development of Rezular in
this indication
This was a disappointing result for the Company, shareholders and IBS-D patients
for whom no effective therapy to address all their symptoms exists. Having made
the decision to discontinue the ARDIS programme, AGI commenced a review of its
business strategy, including a fundamental review of its pipeline products and a
post-hoc analysis of the data from the ARDIS 1 & 3 studies of Rezular. The
Company moved quickly to limit the close out costs of the ARDIS Phase III
programme as well as other project commitments in order to maximise the cash
available to the business pending completion of the strategy review. The results
of that review are made public today and form the basis of AGI's plans to
re-build value in the Company.
Business Strategy
The Company intends to leverage its strength in product development by focusing
on specialty products in areas where unmet medical needs exist. This means that
AGI intends to concentrate its efforts on market segments where the clinical and
regulatory route to approval may be less costly and where commercialisation can
be successfully undertaken by a smaller and more focused specialty company. Some
of these indications will, the Company believes, meet the criteria for Orphan
drug status under regulations of the US Food and Drug administration (FDA).
While the therapeutic focus of the Company up until now has been on GI diseases,
AGI's approach to development and experience is applicable to numerous
therapeutic areas. AGI now intends to pursue products that fit with the
Company's revised business strategy rather than being limited to a single
therapeutic area.
Of the current pipeline products, AGI intends to concentrate its future
development efforts on alternative applications for Rezular and on AGI-004,
AGI's transdermal patch containing mecamylamine where we believe significant
additional value can be created for our business and shareholders.
AGI has identified a number of potential new indications for Rezular and intends
to prioritise, design and execute value-creating clinical trials in these
indications. Where appropriate, study design and endpoints will be reviewed with
the FDA. Rezular is discussed in more detail below. AGI-004 has already
established clinical proof-of-concept in Chemotherapy Induced Diarrhoea (CID)
and AGI is exploring the optimal study design for the next stage of this
product's development.
While it is AGI's intention to advance these programmes using its own resources,
the Company may consider co-development partnerships or strategic alliances with
other pharmaceutical companies.
Non-core products will be monetised and developed through out-licensing or other
partnership arrangements. Based on its current financial resources, AGI believes
that the most productive way to advance AGI-010 controlled-release omeprazole,
AGI-022, a targeted and controlled-release aminosalycilate, and AGI-006, an
upper-GI pro kinetic agent, will be through partnering. This will allow these
products to be financed externally, providing cash and/or future value to AGI.
The Company will pursue the establishment of such partnerships over the next
year. The Company has already started the process of identifying and meeting
with potential partners.
It is the Company's intention to allocate some of its cash resources to the
development of new products if suitable candidates are identified. These should
meet the criteria of being directed to specialty markets where unmet medical
needs exist.
Rezular(TM)
Based on the comprehensive analysis of the ARDIS data including a variety of
post-hoc analyses, the Company reached the following key conclusions in relation
to the efficacy of Rezular in IBS-D:
* The analysis has confirmed the preliminary findings that Rezular at the medium
(112.5mg per day) and high dose (225mg per day) showed a clear effect to
normalise the loose/watery stool pattern of the IBS-D patients (measured by
improvements in stool form using the BSS scale)
*
* Rezular improved stool frequency and quality of life (QOL) and also showed trends to improve urgencyCertain post-hoc analyses did suggest an improvement in pain severity under certain circumstances
Overall, the analysis has confirmed the view of AGI that Rezular may offer an
effective treatment for chronic diarrhea in a variety of conditions,
particularly those associated with altered gut motility.
The immediate focus for AGI is to develop and implement a detailed operational
plan that is consistant with the new business strategy approved by the Board.
Ultimately we are confident that this new strategy will create increased value
in the business.
+-----------------------------------------+-----------------------------------------+
| Dr. Ronan Lambe | Dr. John Devane |
| Chairman | Chief Executive Officer |
| Dublin, 22 September 2009 | |
+-----------------------------------------+-----------------------------------------+
Financial review
Basis of preparation and International Financial Reporting Standards (IFRS)
The financial information for the six months ended 30 June 2009 has been
prepared in accordance with IFRS as adopted by the European Union.
Functional Currency
Commencing on January 1st 2008, AGI has adopted the US Dollar as the functional
currency for the Company. This decision is based on the fact that the Company's
primary market for its products under development are in the US, the majority of
the Company's costs are denominated in US dollars, and it is likely that most
future revenues, whether in the form of license fees, development fees,
royalties or product sales, are likely to be earned in dollars. Previously the
Company's functional currency was the euro as most of its costs were
euro-denominated and its funding was raised in euro.
Operating performance
Revenue
AGI received an initial milestone payment of $1.5 million from Axcan Pharma Inc.
in 2006 related to a co-development agreement for AGI-010, Chronab omeprazole.
This upfront fee has been recognised on a straight line basis over three years,
an estimate of the likely term of the underlying development programme. For the
six months to June 30 2009 a total of $0.3 million was recognised as revenue
(2008: $0.3 million). As of 30 June 2009 the full amount of $1.5 million has
been recognised. In August 2009 AGI announced that, by mutual consent, AGI and
Axcan have terminated this co-development and all associated intellectual
property and ownership of the asset has reverted to AGI. There are no further
financial obligations on either party associated with this termination.
Research and Development expenses
Total Research and Development expenses for the six months to June 30 2009 were
$7.8 million (2008: $8.3 million). R&D costs in both 2008 and 2009 were
dominated by the ARDIS Phase III clinical programmes associated with Rezular. As
a result of the Company's decision to discontinue ARDIS in May 2009, all
significant remaining costs associated with ARDIS were accrued in June 2009 and
therefore R&D costs will be substantially lower in the second half of 2009.
General and Administrative expenses
General and Administrative expenses in the first six months of 2009 were $1.5
million (2008: $2.0 million). This decrease is attributable to the elimination
of salary bonus payments in 2009, a reduced share-based compensation charge as
well as other cost containment measures. As a result of continuing measures to
contain costs AGI expects G&A costs to decline further in the second half of
2009.
Interest Income and other income
The Company earned interest on its cash balances amounting to $0.1 million in
the first six months of 2009 (2008: $0.7 million). Interest income has fallen as
cash balances have reduced and interest rates for cash deposits declined in 2009
compared to 2008. This category also includes an unrealised loss of $21K in 2009
(2008: $469K unrealised gain) arising from the translation, of those cash
balances AGI still holds in euro into dollars at the period end.
Reorganisation expense
A charge of $0.4 million has been recognised in the first half of 2009 to
account for costs associated with making certain positions redundant and the
costs of writing down certain intellectual property. There was no comparable
charge in 2008.
Taxation
The Company has had a loss to date and continues to incur losses. Because of
these losses no charge for tax arose in the first six months of 2009, although
there was a small charge of $0.1 million for the comparable period of 2008.
Share based compensation expense
The Company issues share options to certain employees on an annual basis.
While the options were issued at a strike price equal to the market price of the
Company's shares on the date of grant, a calculation is required of the
potential expense to the Company of issuing those options which is determined
using the Black-Scholes option-pricing formula. A total amount of $0.6 million
was expensed during the first half of 2009 (2008: $0.8 million) for these share
based compensation charges, divided between Research and Development and General
and Administration expenses.
Operating cash flow
Net cash outflow from operating activities in the period was $8.5 million (2008:
$12.5 million), which consisted principally of the loss from operations and
changes in working capital balances. At June 30, 2009, AGI had cash and
short-term deposits of $15.1 million, (2008 $32.8 million). The Company also had
short tem liabilities consisting of trade payables and accruals in the amount of
$2.7 million at 30 June 2009 a large portion of which related to Rezular. These
liabilities are due to be fully discharged in the third quarter of 2009. The
Directors have considered the Company's cash position and are satisfied that it
is sufficient to meet the Company's financial obligations for at least the
coming twelve months.
UNAUDITED CONDENSED CONSOLIDATED INTERIM INCOME STATEMENTS
For the six months ended 30 June 2009
+--------------------------------+--------+-------------+--------------+
| | Notes | Period | Period ended |
| | | ended | 30 June |
| | | 30 June | 2008 |
| | | 2009 | $'000 |
| | | $'000 | |
+--------------------------------+--------+-------------+--------------+
| Revenue | | 288 | 288 |
+--------------------------------+--------+-------------+--------------+
| | | | |
+--------------------------------+--------+-------------+--------------+
| Research and development | | 7,824 | 8,340 |
| expenses | | | |
| (share based payment charge | | | |
| of $322 (2008: $439)) | | | |
+--------------------------------+--------+-------------+--------------+
| General and | | 1,467 | 2,016 |
| administrative | | | |
| expenses | | | |
| (share based | | | |
| payment charge of | | | |
| $242 | | | |
| (2008: $400)) | | | |
+--------------------------------+--------+-------------+--------------+
| Reorganisation expense | | 380 | - |
+--------------------------------+--------+-------------+--------------+
| Total operating | | (9,671) | 10,356 |
| expenses | | | |
+--------------------------------+--------+-------------+--------------+
| Operating loss | | (9,383) | (10,068) |
+--------------------------------+--------+-------------+--------------+
| | | | |
+--------------------------------+--------+-------------+--------------+
| Interest income and | | 100 | 1,121 |
| other income | | | |
+--------------------------------+--------+-------------+--------------+
| | | | |
+--------------------------------+--------+-------------+--------------+
| Loss before tax | | (9,283) | (8,947) |
+--------------------------------+--------+-------------+--------------+
| Income tax | | - | (59) |
+--------------------------------+--------+-------------+--------------+
| Loss for the period | | (9,283) | (9,006) |
+--------------------------------+--------+-------------+--------------+
| | | | |
+--------------------------------+--------+-------------+--------------+
| Basic loss per | | | |
| ordinary share: | | | |
+--------------------------------+--------+-------------+--------------+
| Basic loss per share | 3 | (13.8) | (13.3) |
| ($ cents) | | | |
+--------------------------------+--------+-------------+--------------+
UNAUDITED CONDENSED CONSOLIDATED INTERIM BALANCE SHEETS
+-----------------------------------+------------+--------------+
| | 30 June | 31 December |
| | 2009 | 2008 |
| | $'000 | $'000 |
+-----------------------------------+------------+--------------+
| Non-Current Assets | | |
+-----------------------------------+------------+--------------+
| Property, plant and | 21 | 34 |
| equipment | | |
+-----------------------------------+------------+--------------+
| Intangible assets | 1,618 | 1,793 |
+-----------------------------------+------------+--------------+
| Total Non-Current | 1,639 | 1,827 |
| Assets | | |
+-----------------------------------+------------+--------------+
| | | |
+-----------------------------------+------------+--------------+
| Current Assets | | |
+-----------------------------------+------------+--------------+
| Other current assets | 189 | 163 |
+-----------------------------------+------------+--------------+
| Cash and cash | 15,073 | 23,577 |
| equivalents | | |
+-----------------------------------+------------+--------------+
| Total Current Assets | 15,262 | 23,740 |
+-----------------------------------+------------+--------------+
| Total Assets | 16,901 | 25,567 |
+-----------------------------------+------------+--------------+
| | | |
+-----------------------------------+------------+--------------+
| Current Liabilities | | |
+-----------------------------------+------------+--------------+
| Trade and other | 2,675 | 2,622 |
| payables | | |
+-----------------------------------+------------+--------------+
| | | |
+-----------------------------------+------------+--------------+
| Total Current | 2,675 | 2,622 |
| Liabilities | | |
+-----------------------------------+------------+--------------+
| Total Liabilities | 2,675 | 2,622 |
+-----------------------------------+------------+--------------+
| | | |
+-----------------------------------+------------+--------------+
| Shareholders' Equity | | |
+-----------------------------------+------------+--------------+
| Share capital | 992 | 992 |
+-----------------------------------+------------+--------------+
| Share premium | 75,194 | 75,194 |
+-----------------------------------+------------+--------------+
| Other reserves | 4,751 | 4,187 |
+-----------------------------------+------------+--------------+
| Retained loss | (66,711) | (57,428) |
+-----------------------------------+------------+--------------+
| Total Shareholders' | 14,226 | 22,945 |
| Equity | | |
+-----------------------------------+------------+--------------+
| Total Shareholders' | 16,901 | 25,567 |
| Equity and Liabilities | | |
+-----------------------------------+------------+--------------+
| | | |
+-----------------------------------+------------+--------------+
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CASH FLOWS
+----------------------------------------------+-------------+------------+
| | 30 June | 30 June |
| | 2009 | 2008 |
| | $'000 | $'000 |
+----------------------------------------------+-------------+------------+
| Loss for the period | (9,283) | (9,006)) |
+----------------------------------------------+-------------+------------+
| Adjustments to reconcile loss to | | |
| net cash used in operating | | |
| activities: | | |
+----------------------------------------------+-------------+------------+
| Depreciation of property, plant | 13 | 18 |
| and equipment | | |
+----------------------------------------------+-------------+------------+
| Amortisation and writedown of | 175 | 70 |
| intangibles | | |
+----------------------------------------------+-------------+------------+
| Interest income | (100) | (652) |
+----------------------------------------------+-------------+------------+
| Income tax | - | 59 |
+----------------------------------------------+-------------+------------+
| Share-based compensation | 564 | 839 |
+----------------------------------------------+-------------+------------+
| Operating cash outflow before | (8,631) | (8,672) |
| changes in working capital | | |
+----------------------------------------------+-------------+------------+
| Increase in other current assets | (36) | (84) |
+----------------------------------------------+-------------+------------+
| Increase/(decrease) in trade and | 51 | (4,544) |
| other payables | | |
+----------------------------------------------+-------------+------------+
| Cash used by operations | (8,616) | (13,300) |
+----------------------------------------------+-------------+------------+
| Interest received | 110 | 826 |
+----------------------------------------------+-------------+------------+
| Tax refunded/(paid) | 2 | (25) |
+----------------------------------------------+-------------+------------+
| Net cash outflow from operating | (8,504) | (12,499) |
| activities | | |
+----------------------------------------------+-------------+------------+
| Investing activities | | |
+----------------------------------------------+-------------+------------+
| Acquisition of intellectual property and | - | (221) |
| other investments | | |
+----------------------------------------------+-------------+------------+
| Net cash used by investing | - | (221) |
| activities | | |
+----------------------------------------------+-------------+------------+
| Net (decrease) in cash and cash | (8,504) | (12,720) |
| equivalents | | |
+----------------------------------------------+-------------+------------+
| Cash and cash equivalents at the | 23,577 | 45,503 |
| beginning of period | | |
| | | |
+----------------------------------------------+-------------+------------+
| Cash and cash equivalents at the | 15,073 | 32,783 |
| end of the period | | |
+----------------------------------------------+-------------+------------+
| | | |
+----------------------------------------------+-------------+------------+
| | | |
+----------------------------------------------+-------------+------------+
UNAUDITED CONDENSED CONSOLIDATED INTERIM STATEMENTS OF CHANGES IN SHAREHOLDERS'
EQUITY
+-------------------+------------+----------+---------+----------+----------+----------+
| | Number | Ordinary | Share | Other | Retained | Total |
| | of | share | Premium | Reserves | deficit | Amount |
| | Shares | Capital | $'000 | $'000 | $'000 | $'000 |
| | | $'000 | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Balance | 67,412,783 | 992 | 75,194 | 2,649 | (39,225) | 39,610 |
| at 31 | | | | | | |
| December | | | | | | |
| 2007 | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Loss | - | - | - | - | (9,006) | (9,006) |
| for | | | | | | |
| the | | | | | | |
| period | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Share-based | - | - | - | 839 | - | 839 |
| compensation | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Balance | 67,412,783 | 992 | 75,194 | 3,488 | (48,231) | 31,443 |
| at 30 | | | | | | |
| June | | | | | | |
| 2008 | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Loss | - | - | - | - | (9,197) | (9,197) |
| for | | | | | | |
| the | | | | | | |
| period | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Share-based | - | - | - | 699 | - | 699 |
| compensation | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Balance | 67,412,783 | 992 | 75,194 | 4,187 | (57,428) | 22,945 |
| at 31 | | | | | | |
| December | | | | | | |
| 20087 | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Loss | - | - | - | - | (9,283) | (9,283) |
| for | | | | | | |
| the | | | | | | |
| period | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Share-based | - | - | - | 564 | - | 564 |
| compensation | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| Balance | 67,412,783 | 992 | 75,194 | 4,751 | (66,711) | 14,226 |
| at 30 | | | | | | |
| June | | | | | | |
| 2009 | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
| | | | | | | |
+-------------------+------------+----------+---------+----------+----------+----------+
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM
FINANCIAL STATEMENTS
1 BASIS OF PREPARATION
These unaudited condensed consolidated interim financial statements (the interim
financial statements) have been prepared in accordance with IFRS that are
adopted by the European Union (EU) and effective at 30 June 2009.The interim
financial statements do not include all of the information required for full
annual financial statements.
These interim financial statements are presented in US Dollar rounded to the
nearest thousand, being the functional currency of the parent company and the
group companies. They are prepared on the historical cost basis, except for
share based payments, which are stated at fair value.
The accounting policies applied by AGI in these interim financial statements are
the same as those applied by AGI in its consolidated financial statements as at
and for the year ended 31 December 2008.
The preparation of interim financial statements requires management to make
judgements, estimates and assumptions that affect the application of policies
and reported amounts of assets and liabilities, income and expenses. Actual
results could differ materially from these estimates. In preparing these interim
financial statements, the significant judgements made by management in applying
our accounting policies and the key sources of estimation uncertainty were the
same as those that applied to the consolidated financial statements as at and
for the year ended 31 December 2008.
These interim financial statements do not constitute Statutory Financial
Statements of the Group within the meaning of Regulation 40 of the European
Communities (Companies: Group Accounts) Regulations, 1992. Statutory Financial
Statements for the year ended 31 December 2008 have been filed with the
Companies Office. The auditor's report on those financial statements was
unqualified.
2 FUNCTIONAL CURRENCY
On 1 January 2008, the functional currency of the Company changed from Euro to
US Dollars as the Company's cost structure became primarily US Dollar based. The
Company's principal clinical trials are carried out in the United States and
billed in dollars. In addition the Company earns only US Dollar revenue. The US
Dollar is the currency of the primary economic environment in which the Company
operates. At 1 January 2008 the Company translated its financial statements at
31 December 2007 to US Dollars at the exchange rate prevailing at that date.
Transactions in currencies other than the functional currency of the entities
are recorded at the rate of exchange prevailing on the date of the transactions.
Monetary assets and liabilities denominated in foreign currencies at the balance
sheet date are retranslated into the respective functional currencies of Group
entities at the rate of exchange prevailing at the balance sheet date.
3 LOSS PER SHARE
Basic loss per share is computed by dividing the loss for the period available
to ordinary shareholders by the weighted average number of ordinary shares
outstanding during the period. Diluted loss per share is computed by dividing
the loss for the period, by the weighted average number of ordinary shares
outstanding and, when dilutive, adjusted for the effect of all potentially
dilutive shares, including stock options, warrants, and convertible debt
securities on an as-if-converted basis.
The following table sets forth the computation for basic and diluted loss per
share for the six months ended 30 June 2009 and 2008:
+---------------------------------------------+--------------+--------------+------------+
| | 30 June 2009 | 30 June |
| | $000 | 2008 |
| | | $000 |
+------------------------------------------------------------+--------------+------------+
| Numerator: | | |
+------------------------------------------------------------+--------------+------------+
| Loss attributable to ordinary shareholders | (9,283) | (9,006) |
+------------------------------------------------------------+--------------+------------+
| | | |
+------------------------------------------------------------+--------------+------------+
| Denominator: | | |
+------------------------------------------------------------+--------------+------------+
| Denominator for basic-weighted average number of shares | 67,412,783 | 67,412,783 |
+------------------------------------------------------------+--------------+------------+
| | | |
+---------------------------------------------+--------------+--------------+
| Basic loss per share: | | |
+------------------------------------------------------------+--------------+------------+
| Basic loss per share (US$ cents) | (13.8) | (13.3) |
+------------------------------------------------------------+--------------+------------+
| | | |
+---------------------------------------------+--------------+--------------+------------+
Potentially dilutive instruments, such as share options have not been treated as
dilutive as the Group made a loss in both periods.
4 RELATED PARTY TRANSACTIONS
(a) Transactions with founding members and shareholders
Frank Kenny, John O'Sullivan and Peter Sandys are Directors of the Company and
are board nominees of Delta Partners, ACT Venture Capital and Seroba Bioventures
respectively. Fees of $25,000 annually are paid by the Company to each of Delta,
ACT and Seroba in respect of their nominees' appointment.
5 APPROVAL
The unaudited condensed consolidated interim financial statements were approved
by the directors on 17 September, 2009
This information is provided by RNS
The company news service from the London Stock Exchange
END
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