TIDMAGI 
 
RNS Number : 1352K 
AGI Therapeutics plc 
14 April 2010 
 
 
                             AGI Therapeutics, plc 
 
        Preliminary financial results for the year ended 31 December 2009 
 
        AGI reports solid cash position, reduced cost base and progress 
                            on new product pipeline 
 
 
Dublin, Ireland,14th April 2010 - AGI Therapeutics plc ("AGI" or the "Company"), 
a specialty pharmaceutical company, today reports preliminary audited financial 
results for the year  ended 31 December 2009, and provides a business update to 
shareholders. 
 
Financial highlights 
 
 
·     Cash and short-term deposits at 31 December 2009 of $12.0 million, (2008: 
$23.6 million) 
·     Research and Development (R&D) spend of $8.3 million (2008:$15.9 million) 
·     Reduced net loss of $10.6 million (2008: $18.2 million) 
·     Loss per ordinary share of 15.8 cents (2008: 27.0 cents) 
 
Operational Summary 
 
In May 2009, we announced that we were discontinuing the development of our lead 
development programme, Rezular(TM), in the broad indication of 
diarrhoea-predominant irritable bowel syndrome (IBS-D) following disappointing 
results from our Phase III ARDIS-1 efficacy study. In conjunction with this 
decision we terminated the ongoing Phase III ARDIS-3 safety study. 
 
 In September 2009, we announced a new business strategy for the Company, 
focusing onthe development of specialty products for unmet medical needs, 
without being restricted to any specific therapeutic area. In particular, we 
announced our intention to pursue products in specialty niche or "orphan" 
designated markets that represent an attractive return on investment for a 
company of our size. 
 
We have commenced the implementation of this new business strategy and 
restructured the activities of the Company accordingly. 
 
New Product Pipeline 
 
·     We have conducted extensive commercial, technical and intellectual 
property (IP) due diligence on a number of external product candidates with a 
view to in-licensing in order to build a robust and enhanced product pipeline. 
While some opportunities have been rejected for various regulatory, clinical or 
commercial reasons, we continue to actively pursue discussions on selected 
promising candidates with the objective of adding one or more new programmes to 
our portfolio during 2010. These products will meet our criteria of targeting 
unmet medical needs in specialty markets and will have potential in-market sales 
 which provide an attractive return on investment for AGI. 
 
·     We have also applied the same technical, commercial and risk-return 
analysis to our internal product pipeline: 
 
o  As outlined in September of 2009, we completed a comprehensive review of the 
data from ARDIS-1, our Phase III clinical efficacy study of Rezular in IBS-D. We 
subsequently met with the US Food and Drug Administration (FDA) and key opinion 
leaders to explore future development possibilities for this product. While we 
believe, based on an analysis of the ARDIS data, that there may be potential to 
develop this product in a sub-set of severe IBS-D patients, we do not at this 
time intend to fund the development of Rezular in any IBS-related indication, 
but will determine if there is a potential to out-license this opportunity. We 
continue to evaluate the potential benefits of Rezular in a number of chronic 
diarrhoea indications that represent interesting specialty and potential orphan 
indications and proof of concept trials are currently under consideration. 
 
o  We have also commenced pre-clinical evaluation of Rezular in a new, 
non-gastrointestinal (GI) therapeutic area. The unique pharmacology and 
mechanism of action of this drug may provide  a valuable therapeutic benefit in 
this orphan indication. These studies are ongoing and we await data before 
deciding upon next steps. 
 
o  We continue to actively seek and engage with potential development partners 
for the other products in our pipeline. These include: AGI-004, transdermal 
mecamylamine for the treatment of Chemotherapy-Induced Diarrhoea (CID), AGI-010, 
a controlled-release omeprazole directed to nocturnal acid breakthrough (NAB), 
AGI-022, a targeted and controlled-release aminosalicylate for ulcerative 
colitis and AGI-006, an upper-GI prokinetic agent. 
 
We are pleased to announce significant progress in establishing an IP platform 
in relation to our aminosalicylate (ASA) delivery system. Specifically a notice 
of allowance of claims has been granted in the US for our lead patent 
application and we expect progress shortly on the European Patent Office 
equivalent. 
 
Operations review: costs reduced 
 
 
In the last quarter of 2009 and continuing into 2010, we took action to reset 
the cost base of the Company and align it more closely with the earlier stage of 
development of our product pipeline. 
 
Specifically; 
 
·     We closed our US office, reducing our overall headcount, and have 
established a panel of regulatory and clinical consultants to provide expert 
input into our programmes. In particular we are pleased to have retained Dr. 
David Young on our Board and look forward to his advice and guidance in relation 
to FDA interactions. 
 
·     We made significant changes to our remaining cost structure.  Our 
day-to-day running costs have been reduced by more than half as a result of 
these changes. 
 
·     We terminated all ongoing clinical programmes associated with Rezular in 
IBS-D and will in future only invest in programmes designed to provide proof of 
concept data for potential new orphan and unmet need indications for this 
compound. 
 
·     We will limit ongoing spending on our IP portfolio (patents and patent 
applications) to  those products that are part of our new pipeline or where we 
believe there is good possibility of partnering in the future. 
 
As a result of these efforts, at the end of 2009 we had a cash balance of $12.0 
million which we intend to invest in our new development pipeline. It is our 
intention to progress a selected number of projects to a stage where they will 
have tangible worth that will enhance shareholder value. 
 
 
 
Commenting on the results, Dr. John Devane, CEO of AGI, said: 
 
"While 2009 proved to be a very difficult year for AGI, we have successfully 
resized our operations and are implementing a strategy to rebuild our pipeline. 
While we have yet to announce the details of our new product pipeline, we have 
already identified a number of attractive opportunities on which we are 
undertaking rigorous technical and commercial due diligence, and believe this 
will result in a valuable  pipeline of products that will re-build value in our 
business. " 
 
 
 
 
 
Contact Information: 
 
+------------------------------------+------------------------------+ 
| AGI Therapeutics plc.              | Tel: +353 1 449 3254         | 
+------------------------------------+------------------------------+ 
| David Kelly, Chief Financial       |                              | 
| Officer                            |                              | 
+------------------------------------+------------------------------+ 
|                                    |                              | 
+------------------------------------+------------------------------+ 
| Davy                               | Tel: +353 1 614 8761         | 
| John Frain                         |                              | 
+------------------------------------+------------------------------+ 
 
For further information: www.agitherapeutics.com 
 
 
Notes to Editors: 
 
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 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. 
 
 
AGI Therapeutics, plc 
 
Chairman's and Chief Executive's review: 
 
Overview 
 
The first half of 2009 was dominated by activities associated with progressing 
AGI's lead product, Rezular, for the treatment of IBS-D. We received the 
top-line results from the ARDIS-1 study in mid-May. 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, 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 analysis of these data, we 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 decided to cease development of Rezular in 
this indication. 
 
New Business Strategy 
 
Following a full review of our business and pipeline, in September 2009 we 
announced our new business strategy that is now being pursued in 2010. We are 
leveraging our strengths in product and clinical development to focus on 
developing specialty products for areas where unmet medical needs exist. This 
means that we intend to concentrate our development efforts and spend 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, we believe, meet the 
criteria for orphan drug status under the current guidelines of the FDA and 
other regulatory bodies. 
 
As part of this process, we undertook an analysis of our existing pipeline to 
identify if new development paths existed for our products, and as a result 
announced that we would consider future development efforts on alternative 
indications for Rezular. We continue to recognise that Rezular has a unique and 
novel pharmacology which may have utility in indications outside 
gastroenterology. We have consulted directly with expert clinicians in one 
non-GI therapeutic area of interest and have commenced robust pre-clinical 
studies to test the potential benefits of Rezular in this indication. We are not 
yet at liberty to disclose the therapeutic area at this time due to ongoing 
patenting activities.   We have also identified and are considering the 
potential of other development pathways for Rezular in niche GI conditions which 
have chronic diarrhoea as a primary symptom. 
 
Since closing down the Phase III Rezular programme, we have spent significant 
time and effort in evaluating potential new additions to our pipeline. For each 
identified opportunity we have applied similar assessment criteria. The product 
should be in a specialist niche market, preferably one where it will receive 
"orphan drug" status in the US and/or Europe, and be capable of being developed 
by AGI to a significant value-generating inflection point. Other important 
features assessed include market exclusivity, product differentiation, 
regulatory pathway, commercial sales potential and  IP protection. 
 
In recent months we have entered into full due diligence on a number of 
potential opportunities. Inevitably the majority of the products evaluated did 
not meet all the above criteria. Nevertheless, a selected number of 
opportunities have been advanced and we are optimistic that we will bring one or 
more new products into our pipeline during 2010. 
 
With regard to products already in our pipeline that no longer meet our criteria 
for internal investment, we will now seek to realise value through potential 
out-licensing or sale of these products and associated IP assets. 
 
While the failure of the ARDIS Phase III programme has been a significant 
challenge, we believe that our actions in the latter months of 2009 to 
restructure the Company, establish a new viable and attractive business 
strategy, and conserve cash resources were prudent actions taken in the best 
interests of our shareholders. 
 
We believe that current trends in the pharmaceutical industry auger well for 
companies such as ours. Large pharmaceutical companies around the globe are 
cutting back on internal development activities and will rely more on 
in-licensing products with established clinical benefit, and with an increasing 
focus on specialty rather than primary care-driven markets. We believe that a 
sustainable business can be created through targeted investment and building a 
portfolio of specialty products which will ultimately be out-licensed to other 
companies. The key challenge is to select those opportunities that are both 
attractive from a risk-reward perspective and can be progressed by AGI to a 
stage where value can be realised, for instance, through a transaction with a 
third party.  We believe that successful execution of our strategy and playing 
to the strengths of our management team will drive the future growth of our 
Company and create significant value for you, our shareholders. 
 
 
 
 
Dr. Ronan Lambe                                                       Dr. John 
Devane 
Chairman 
Chief Executive Officer 
Dublin, 14 April 2010 
 
 
 
AGI Therapeutics, plc 
 
Financial review 
for the year ended 31 December 2009 
 
Revenue 
 
AGI recorded its first revenues as a result of a license agreement signed in 
September 2006, with Axcan Pharma Inc, a Canadian headquartered specialty 
pharmaceutical company with a focus on GI diseases.  An initial milestone 
payment of $1.5 million has been recognised on a straight line basis over 
approximately three years, in conjunction with the term of the underlying 
development programme.  For the year to 31 December 2009, a total of $289,000 
was recognised as revenue in respect of this licence agreement (2008: $577,000). 
This license agreement has now been recognised in full. In August 2009, Axcan 
and AGI terminated this agreement and all product rights have reverted to AGI. 
 
Research and development expenses 
 
R&D expenses for the year ended 31 December 2009 were $8.3 million (2008: $15.9 
million).  During 2009 and 2008, the Company was conducting a Phase III pivotal 
clinical programme of Rezular(TM) for the treatment of IBS-D (ARDIS).  This 
programme accounted for over 95% of direct R&D expenses in 2009 and 2008.  In 
May 2009, the Phase III programme was terminated when headline data from the 
ARDIS study showed that Rezular had not met its primary efficacy endpoint. 
 
General and administrative expenses 
 
General and administrative (G&A) expenses in 2009 were $2.6 million (2008: $3.5 
million).  The reduction in G&A expenses is due to the Company's efforts to 
reduce its cost base following the termination of the ARDIS programme. 
 
Restructuring and impairment charges 
 
For the year ended 31 December 2009, the Company incurred $321,000 (2008: Nil), 
relating to the termination of certain positions, as well as the impairment of 
certain acquired patents and computer and office equipment, in conjunction with 
the closure of our US office. 
 
Interest income and expense 
 
The Company earned interest on its cash balances, primarily the proceeds of the 
IPO during 2006.  This amounted to $140,000 (2008: $1.0 million).  The decline 
in interest income reflects both the declining interest rates available for 
deposits as well as the declining cash balances available for deposit. 
 
Other income/(expenses) comprise foreign exchange gains/(losses) of $53,000 
(2008: ($362,000)). 
 
Taxation 
 
The Company has incurred losses to date, and no tax charge arises for 2009 or 
2008. 
 
Share based compensation expense 
 
 During 2009, the Company issued 3,830,000 (2008: 1,410,000) share options 
to certain employees.  The Company accounts for the fair value of option grants 
as a charge in the income statement, using the Black-Scholes option-pricing 
model.  A charge of $0.8 million (2008: $1.5 million) was recognised in 2009 in 
respect of share based compensation expense, disclosed within research and 
development and general and administration expenses. 
 
AGI Therapeutics, plc 
 
Condensed Consolidated Income Statement 
for the year ended 31 December 2009 
 
Note2009                         2008 
                  $'000                        $'000 
 
Revenue - continuing operations                     320 
 577 
               ______                     ______ 
 
Operating expenses 
 
Research and development expenses 
(share based payment charge of $330,000 
(2008:  $853,000)) 
      (8,271)                    (15,937) 
General and administrative expenses 
  (share based payment charge of $477,000 
(2008: $685,000)) 
      (2,559)                      (3,473) 
Restructuring and impairment charges                    3 
(321)                               - 
               ______                     ______ 
 
Loss from operating activities - continuing 
  operations 
   (10,831)                    (18,833) 
               ______                     ______ 
 
Finance income/finance expense 
 
Interest income 
              140                           992 
Other income/(expense) 
         53                          (362) 
               ______                     ______ 
 
Net finance income 
        193                           630 
               ______                     ______ 
 
Loss before income tax                                  (10,638) 
   (18,203) 
Income tax 
                     -                                - 
               ______                     ______ 
 
Net loss for the year - attributable to equity 
  holders of the Company 
(10,638)                    (18,203) 
Loss per ordinary share 
Basic and diluted loss per ordinary share                4(15.8) 
       (27.0) 
 
 
AGI Therapeutics, plc 
 
Condensed Consolidated Statement of Comprehensive Income/(Loss) 
For  the year ended 31 December 2009 
 
2009                         2008 
                  $'000                        $'000 
 
Net loss for the year                 (10,638)                    (18,203) 
 
               ______                     ______ 
 
Total comprehensive income/(loss) for the year(10,638) 
(18,203) 
 
AGI Therapeutics, plc 
 
Condensed Consolidated Balance Sheet 
at 31 December 2009 
 
Note                   2009                         2008 
                  $'000                        $'000 
Non-current assets 
Property, plant and equipment                            3 
        2                             34 
Intangible assets                                                 3 
          1,549                        1,793 
                     ______                     ______ 
 
Total non-current assets                        1,551 
1,827 
                     ______                     ______ 
Current assets 
Other current assets 
            75                           163 
Cash and cash equivalents 
11,972                      23,577 
 
                  ______                     ______ 
Total current assets                      12,047                      23,740 
 
                     ______                     ______ 
Total assets                      13,598                      25,567 
Shareholders' equity 
Share capital 
                992                           992 
Share premium 
       75,194                      75,194 
Share based compensation reserve                         4,994 
     4,187 
Retained deficit 
         (68,066)                    (57,428) 
 
                  ______                     ______ 
Total shareholders' equity 
13,114                      22,945 
 
                  ______                     ______ 
Current liabilities 
Trade and other payables 
       484                        2,622 
 
                  ______                     ______ 
Total current liabilities 
         484                        2,622 
 
                  ______                     ______ 
Total liabilities 
               484                        2,622 
 
                  ______                     ______ 
 
Total shareholders' equity and liabilities                              13,598 
                   25,567 
 
 
AGI Therapeutics, plc 
 
Condensed Consolidated Statement of Cash Flows 
for  the year ended 31 December 2009 
 
                   2009                         2008 
 
                     $'000                        $'000 
 
Loss for the year 
        (10,638)                    (18,203) 
 
Adjustments to reconcile loss to net cash used in 
 operating activities: 
Depreciation of property, plant and equipment 
22                             37 
Amortisation of intangible assets 
     143                           143 
Interest income 
             (140)                         (992) 
Foreign currency (gain)/(loss) 
       (53)                          362 
Impairment of intangible assets and property, plant 
  and equipment 
             111                                - 
Share based payment expense 
 807                        1,538 
               ______                     ______ 
Operating cash outflow before changes 
  in working capital                                            (9,748) 
          (17,115) 
 
Decrease/(increase) in other current assets 
89                           291 
(Decrease)/increase in trade and other payables                       (2,138) 
                  (5,484) 
               ______                     ______ 
 
Cash absorbed by operations               (11,797)                    (22,308) 
 
Interest received 
              139                        1,227 
Tax paid 
                       -                          (263) 
 
                  ______                     ______ 
Net cash outflow from 
operating activities 
    (11,658)                    (21,344) 
 
                  ______                     ______ 
Cash flows from investing activities 
Acquisition of intangible assets 
           -                          (221) 
               ______                     ______ 
Net cash used in investing activities -                          (221) 
               ______                     ______ 
 
Net decrease in cash and cash equivalents                             (11,658) 
                 (21,565) 
Cash and cash equivalents at the beginning 
  of the year 
             23,577                      45,504 
Effect of foreign exchange rate changes 
 53                          (362) 
               ______                     ______ 
Cash and cash equivalents at the 
  end of the year                11,972                      23,577 
 
 
 
AGI Therapeutics, plc 
 
Condensed Consolidated statement of changes in shareholders' equity 
for the year  ended 31 December 2009 
 
        Ordinary                                     Share Based 
 
 
                                                         Number 
     Share                  Share     Compensation      Retained 
 
Total 
                                                      of Shares 
   Capital             Premium               Reserve           Deficit 
                                               Amount 
                        $'000                    $'000 
$'000             $'000 
    $'000 
 
Balance at 1 January 2008          67,412,783                           992 
            75,194                      2,649         (39,225) 
                                         39,610 
 
Comprehensive income/(loss): 
Net loss for the year                                     - 
          -                           -                             - 
(18,203)                                                           (18,203) 
Other comprehensive income                      - 
-                           -                             - 
-                                                                      - 
 
Total comprehensive income/(loss)             -                                - 
                          -                             -                     - 
                                                         (18,203) 
 
Share-based compensation                         - 
 -                           -                      1,538                     - 
                                                            1,538 
 
 
Balance at 31 December 2008    67,412,783                           992 
        75,194                      4,187         (57,428) 
                                     22,945 
 
Comprehensive income/(loss): 
Net loss for the year                                     - 
          -                           -                             - 
(10,638)                                                           (10,638) 
Other comprehensive income                      - 
-                           -                             - 
-                                                                      - 
 
Total comprehensive income/(loss)             -                                - 
                          -                             -                     - 
                                                         (10,638) 
 
Share-based compensation                         - 
 -                           -                         807                     - 
                                                                807 
 
Balance at 31 December 2009 67,412,783                           992 
     75,194                      4,994         (68,066) 
                                  13,114 
 
 
 
 
 
AGI Therapeutics, plc 
 
Notes to the condensed consolidated preliminary financial information 
for  the year ended 31 December 2009 
 
1    Basis of preparation 
 
      The condensed consolidated preliminary financial information included in 
the preliminary financial results announcement, which should be read in 
conjunction with the 2008 Annual Report, has been prepared in accordance with 
the measurement principles of International Financial Reporting Standards 
("IFRS") as adopted by the European Union ("EU"), and as effective at 31 
December 2009.  The consolidated financial statements of the Company for the 
prior year are available on the Company's website 
http://www.agitherapeutics.com. 
 
      The condensed consolidated preliminary financial information presented 
herein does not constitute the Company's statutory financial statements for the 
years ended 31 December 2009 and 2008, within the meaning of the Companies Acts, 
1963 to 2009 but is derived from those financial statements.  The statutory 
financial statements for the year ended 31 December 2009 will be finalised on 
the basis of the financial information presented by the directors in this 
preliminary results announcement, and together with the independent auditor's 
report thereon, will be filed with the Irish Registrar of Companies following 
the Company's Annual General Meeting and will also be available on the Company's 
website.   Statutory financial statements for the year ended 31 December 2008 
have been filed with the Irish Registrar of Companies.  The auditor's report on 
those financial statements was unqualified. 
 
The financial information is presented in US dollars rounded to the nearest 
thousand, being the functional currency of the parent company and its 
subsidiaries.  It has been prepared on the historical cost basis of accounting, 
except for share based payments, which are based on fair value determined at the 
grant date of the relevant share option. 
 
The condensed consolidated preliminary financial information includes the 
results and financial position of the Company and all of its subsidiary 
undertakings.  All significant intercompany account balances, transactions, and 
any unrealised gains and losses or income and expenses arising from intercompany 
transactions have been eliminated in preparing the financial information. 
 
The preparation of the condensed consolidated preliminary financial information 
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 this financial information, the significant judgements 
made by management in applying the Company's accounting policies and the key 
sources of estimation uncertainty are the same as those that applied to the 
consolidated financial statements as at and for the year ended 31 December 2008. 
 
The accounting policies applied in the condensed consolidated preliminary 
financial information are the same as those applied in the consolidated 
financial statements as at and for the year ended 31 December 2008, as set out 
on pages 32 to 36 of the 2008 Annual Report, except for the application of new 
standards as explained below. 
 
The following new standards and amendments to standards are mandatory for the 
first time for the financial year beginning 1 January 2009. 
AGI Therapeutics, plc 
 
Notes(continued) 
 
1    Basis of preparation (continued) 
 
·    IFRS 8 - Operating Segments.  We adopted IFRS 8 which replaces IAS 14 - 
Segmental Reporting ("IAS 14"), for the year ended 31 December 2009.  IFRS 8 
requires a "management approach" under which segment information is presented on 
the same basis as that used for internal reporting purposes.  IAS 14 required 
identification of two sets of segments - one based on business units and the 
other on geographical areas.  IFRS 8 requires additional disclosures around 
identifying segments and their products and services.  Our operations are 
organised into one business unit, the development of drug products.  There has 
been no change to the operating segment as a result of the adoption of IFRS 8 
and the reportable segment is consistent with that previously reported under the 
primary business segment format of the segment reporting under IAS 14. 
 
·    IAS 1 (revised) - Presentation of Financial Statements.  The presentation 
of our primary financial statements has been updated to reflect the requirements 
of IAS 1 (revised), effective from 1 January 2009.  Accordingly, we now present 
two performance statements: an income statement and a statement of comprehensive 
income/(loss). Also, the revised standard includes the statement of changes in 
shareholders' equity as a primary statement, rather than as a note to the 
financial statements. 
 
The Board of Directors, approved the condensed consolidated preliminary 
financial information for the year ended 31 December 2009 on 13 April 2010. 
 
2    Going concern 
 
The directors are satisfied that the Company has sufficient cash resources to 
support its research programmes for a period of twelve months from the date of 
approval of this financial information and therefore the Company can continue to 
trade during this period.  Consequently, the directors have adopted the going 
concern basis in the preparation of the financial information. 
 
 
3    Restructuring and impairment charges 
 
For the year ended 31 December 2009, the Company incurred $321,000 (2008: Nil), 
relating to the termination of certain positions, as well as the impairment of 
certain acquired patents and computer and office equipment, in conjunction with 
the closure of our US office. 
 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |       2009 |          |       2008 | 
|                                               | |       $000 |          |       $000 | 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |        210 |          |          - | 
| Severance and other expenses                  | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Impairment of intangible assets               | |        101 |          |          - | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Impairment of property, plant and equipment   | |         10 |          |          - | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Total restructuring and impairment charges    | |        321 |          |          - | 
|                                               | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
AGI Therapeutics, plc 
 
Notes(continued) 
 
4    Loss per ordinary 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, on an as-if-converted basis. 
The following table sets forth the computation for basic and diluted loss per 
share for the year ended 31 December 2009 and 2008: 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |       2009 |          |       2008 | 
|                                               | |       $000 |          |       $000 | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Numerator:                                    | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Loss attributable to ordinary shareholders    | |   (10,638) |          |   (18,203) | 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Denominator:                                  | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Denominator for basic-weighted average number | | 67,412,783 |          | 67,412,783 | 
| of shares                                     | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Basic and diluted loss per share:             | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
| Basic and diluted loss per share (US$ cents)  | |     (15.8) |          |     (27.0) | 
|                                               | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
|                                               | |            |          |            | 
+-----------------------------------------------+-+------------+----------+------------+ 
 
For the years ended 31 December 2009 and 2008, there was no difference in the 
weighted average number of ordinary shares used for the basic and diluted net 
loss per ordinary share computation, as the effect of all potentially dilutive 
shares are anti-dilutive due to the existence of net losses of the Company.  At 
31 December 2009, there were share options outstanding of 6,576,948 (2008: 
6,207,000) which could potentially have a dilutive impact in the future, but 
which were anti-dilutive in 2009 and 2008. 
 
5     Related party transactions 
 
In January 2008 the Company acquired intellectual property from J. Dev, a 
company owned and controlled by John Devane, a director of the Company, for 
consideration of $221,000. 
 
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 $24,820 annually are paid by the company to each of 
Delta, ACT and Seroba in respect of their nominees' appointment. 
 
Remuneration of key management personnel, defined as the executive directors of 
the Company, totaled $1,816,000 (2008: $2,668,000) during the year as follows: 
AGI Therapeutics, plc 
 
Notes (continued) 
 
5Related party transactions 
                 2009                    2008 
$'000                    $'000 
 
      Wages, salaries and bonuses 
         1,066                   1,361 
      Post employment benefits - contributions to defined 
 
        contribution pension plan 
                  122                      156 
      Share-based compensation expense 
      628                   1,151 
 
                              _____                  _____ 
 
Total remuneration of key management personnel                  1,816 
       2,668 
 
                 2009                    2008 
NumberNumber 
Number of share options granted 
        during the period 
              3,410,000            1,130,000 
 
 
      Number of share options outstanding 
        at the year-end 
              6,576,948            5,055,342 
 
      No loans, quasi-loans or other guarantees have been given to any of the 
directors during the year (2008: nil) and no such transactions existed at the 
year end. 
 
 
6     Subsequent events 
There were no events subsequent to the balance sheet date, requiring adjustment 
to, or disclosure in, the condensed consolidated financial information. 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 FR EAKLDFESEEFF 
 

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