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OMH Osmetech

2.15
0.00 (0.00%)
10 May 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Osmetech LSE:OMH London Ordinary Share GB00B0K29R51
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 2.15 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

2009 Prelim Results

19/03/2010 7:01am

UK Regulatory



 

TIDMOMH 
 
RNS Number : 8466I 
Osmetech PLC 
19 March 2010 
 

 
 
Date: 19 March 2010 
 
Contact details: 
 
+--------------------------------------+------------------+ 
| Osmetech plc                         |                  | 
+--------------------------------------+------------------+ 
| Jon Faiz Kayyem (Chief Executive     | +1 626 463 2000  | 
| Officer)                             |                  | 
+--------------------------------------+------------------+ 
| David Sandilands                     | +44 207 849 6027 | 
+--------------------------------------+------------------+ 
|                                      |                  | 
+--------------------------------------+------------------+ 
| Canaccord Adams                      |                  | 
+--------------------------------------+------------------+ 
| Henry Fitzgerald-O'Connor / Robert   | +44 207 050 6500 | 
| Finlay                               |                  | 
+--------------------------------------+------------------+ 
 
 
 
                   Osmetech plc ('Osmetech' or the 'Company') 
 
    Osmetech plc preliminary results for the 12 months ended 31 December 2009 
 
 
 
Chairman's statement 
We have today announced a proposal to be put before Osmetech Shareholders to 
change the domicile of Osmetech to the United States, by reorganising the 
Osmetech Group such that, pursuant to a Scheme of Arrangement, Osmetech becomes 
a wholly owned subsidiary of GenMark Diagnostics, Inc., ('GenMark') a new 
company incorporated in the United States, and former Osmetech Shareholders 
become shareholders of GenMark.  It is proposed that GenMark will be traded on 
NASDAQ, that Osmetech's AIM trading facility will be cancelled and that GenMark 
will implement an equity fundraising of up to $40 million through an initial US 
public offer on NASDAQ. 
 
We believe that the proposal to move to a US listing on NASDAQ is in the best 
interests of Osmetech shareholders. This is the natural next step in the 
evolution of the Company's shareholder base which has seen a steady growth in US 
ownership since 2006, including a significant increase over the last two years 
with approximately 57 per cent. of Osmetech's ordinary shares now being 
beneficially owned by US residents. The proposal will align the place of listing 
with the business activities of the Osmetech Group, which are entirely based in 
the US, and where the Board expects the majority of the Osmetech Group's future 
growth to take place. Currently over 95 per cent. of the Osmetech Group's sales 
and net assets are in the US. The Board considers there to be a potentially 
larger pool of investors in the US than in the UK who are more familiar with the 
Osmetech Group's business model and have a better understanding of the molecular 
diagnostics industry. The Board also believes that there is a general reluctance 
on the part of US investors to invest in UK companies of the size and profile of 
Osmetech unless they have a trading facility in the US.  Furthermore, a 
significant number of emerging healthcare technology companies trade on NASDAQ 
and the Directors believe that there is a greater knowledge and understanding of 
those companies in that market. 
 
The Board believes that a NASDAQ listing would raise the profile of the Group 
amongst the investor community in the US and with potential strategic partners 
and customers.  We also believe that a trading facility on NASDAQ may also 
ultimately provide greater liquidity for Osmetech Shareholders and the Group 
would benefit from its listing being amongst a more appropriate public company 
peer group. 
 
Further details can be found in the proposals announcements and in the Circular 
to be sent to shareholders shortly. 
 
As part of the reorganization of the Group, David Sandilands is today standing 
down as Chief Financial Officer but will continue as a non-executive director of 
the Company until the date on which the Scheme becomes effective. We would like 
to thank David for his significant contribution to the development of the Group 
over many years and his considerable commitment to ensuring an effective 
transition. Steven Kemper has today been appointed Chief Financial Officer of 
the Company.  Since November 2009, Steven Kemper has served as senior vice 
president finance of Osmetech Technology Inc, a wholly owned subsidiary of the 
Company. 
 
We are very excited about the proposals to re-position Osmetech. The business 
has a proven technology capable of meeting the needs of a fast-growth market and 
an attractive business model already exhibiting the potential of providing 
repeatable, high margin revenue streams. We have restructured operations, 
reducing the cost base and strengthening the sales and marketing and management 
teams to enable us to effectively execute our commercial strategy. We now 
believe that we have an excellent opportunity to establish a strong presence in 
the US investment community and properly capitalise the business. This should 
provide a strong platform from which to deliver superior future returns for 
shareholders. 
 
Christopher Gleeson 
Chairman 
19 March 2010 
 
 
Chief Executive Officer's Review 
 
Commercial progress 
 
Our principal commercial objective is to achieve revenue growth through the sale 
of test consumables, both through increasing the installed base of XT-8 Systems 
at customers and by broadening the menu through the launch of new tests. 
 
We have now developed four diagnostic tests for use with our XT-8 System and 
expect to expand this test menu by targeting two to four new tests annually. 
Our Cystic Fibrosis Genotyping Test, which detects pre-conception risks of 
cystic fibrosis, and our Warfarin Sensitivity Test, which determines an 
individual's ability to metabolize the oral anticoagulant warfarin, have 
received FDA clearance.  Our eSensor technology has demonstrated 100% accuracy 
in our clinical trials compared to DNA sequencing for our Cystic Fibrosis 
Genotyping Test and our Warfarin Sensitivity Test.  We have also developed a 
Respiratory Viral Panel Test, which detects the presence of major respiratory 
viruses, and a Thrombosis Risk Test, which detects an individual's increased 
risk of blood clots.  Both of these tests are labeled for investigation use 
only, or IUO.  We have submitted our Thrombosis Risk Test for FDA clearance, and 
we intend to seek FDA clearance for our Respiratory Viral Panel Test.  We also 
have a pipeline of eight potential products in different stages of development 
or design, including diagnostic tests for an individual's ability to metabolize 
Plavix, a commonly prescribed anti-coagulant, and for mutations in a gene known 
as K-ras, which is predictive of an individual's response rates to certain 
prescribed anti-cancer therapies. 
 
We are also developing our next generation platform, the AD-8 System.  We are 
designing the AD-8 System to integrate DNA amplification with our eSensor 
detection technology so that technicians using the AD-8 System will be able to 
place a minimally prepared patient sample into our cartridge and obtain results 
without any additional steps.  We believe this sample-to-answer capability is 
possible as a result of the robust nature of our eSensor detection technology, 
which is able to detect target biomarkers despite sample impurities that we 
believe impair competing technologies.  We are designing our AD-8 System to 
further simplify workflow and provide powerful, cost-effective molecular 
diagnostics capability to a broad class of end users, including hospitals and 
laboratories that currently lack the technical or economic resources to perform 
such testing. 
 
Market opportunity 
 
The global market for molecular diagnostics was estimated to be $1.9 billion in 
2009 and is anticipated to reach $3.6 billion in 2014 according to L.E.K., a 
market research firm.  Molecular diagnostics generally refers to the detection 
and measurement of biomarkers to diagnose disease and to optimize the treatment 
of patients.  We believe that the following factors, among others, are 
contributing to the growth of this market: 
·      Expansion of Genetic Testing for Disease Predisposition.  Advances in the 
understanding of the relationship between an individual's genetics and disease 
have led to increased reliance on molecular diagnostic testing for inherited 
diseases such as cystic fibrosis and thrombosis.  We expect new molecular 
diagnostic tests will be required as researchers continue to discover new 
relationships between genetics and disease, new medical interventions are 
developed and as professional societies set guidelines regarding genetic disease 
and the role of genetic counseling in the interpretation of the results of these 
tests. 
·      Adoption of FDA-Cleared Molecular Diagnostic Testing Methods.  The FDA 
recommends that laboratories and hospitals use FDA-cleared molecular diagnostic 
tests when these tests are available, rather than tests known as "home-brew 
tests" or laboratory developed tests, or LDTs, that are not submitted to the FDA 
for approval.  LDTs are broadly used by reference laboratories and 
research-based hospitals to perform molecular diagnostic tests and are subject 
to strict regulatory requirements.  As a result, we believe reference 
laboratories and research-based hospitals will look to replace their existing 
LDTs and non-FDA-cleared molecular diagnostic tests with FDA-cleared tests as 
they become available. 
·      Advances in Cancer Therapy.  Tailoring treatments to an individual's 
tumor type and genetics is an important trend in cancer therapy.  The FDA has 
required or recommended that molecular diagnostic tests be performed before 
administration of certain drugs, such as Herceptin, Erbitux and Vectibix.  We 
believe many oncologists also independently request molecular diagnostic tests 
to aid in their selection of an optimal cancer therapy.  With an ever growing 
number of expensive and toxic cancer therapies, many of which have a relatively 
low probability of success depending on an individual's genetic make-up, 
molecular diagnostic testing to determine an individual's response to certain 
cancer therapies is economical and clinically beneficial. 
·      Increased Demand for Infectious Disease Diagnostic Panels.  Different 
disease pathogens can produce similar symptoms, but with vastly distinct courses 
of disease progression and required medical treatment responses.  For example, 
pneumonia caused by Mycoplasma may resolve without treatment, while pneumonia 
caused by Legionella will generally require aggressive medication and 
hospitalization.  In order to improve patient care, physicians are increasingly 
requesting infectious disease diagnostic panels to be performed.  According to 
L.E.K., the market for molecular diagnostic testing of infectious diseases in 
the United States was estimated to be $1.1 billion in 2009. 
·      Advances in Personalized Medicine.  Tailoring treatments to an 
individual's genetic profile-called personalized medicine or pharmacogenetics-is 
emerging as an important trend and will drive demand for molecular diagnostic 
testing.  Pharmaceutical companies, clinical researchers and pharmacy benefit 
managers are screening drugs for varied toxicity, dose response and efficacy 
among individuals with different genetic profiles.  Because these industry 
developments may improve clinical outcomes and reduce costs for third-party 
payors, we believe adoption of these tests will become more widespread in a 
managed care environment. 
Fund raising 
During 2009 we raised a total of GBP14,836,579, net of expenses, through the 
placing of new shares to institutional shareholders. 
 
Since the year end, we have secured a $4m (GBP2.5m) debt facility which 
comprises a $2m (GBP1.25m) line of credit facility linked to eligible 
receivables and $2m (GBP1.25m) to finance certain forecast capital expenditure 
that is available until 12 July 2011. 
 
The directors have prepared forecasts for a period ending 31 March 2011 which 
includes a number of assumptions regarding income, expenditure and cashflows. 
They also take into account the new debt facility referred to above. Whilst 
there are uncertainties in preparing the forecasts, the directors have concluded 
that they have a reasonable expectation that the Group will be able to operate 
within its available resources and there will be sufficient funds to meet its 
liabilities as they fall due for at least 12 months from the date of approving 
this financial information. 
 
Consistent with other companies in the sector, the Board are aware that they 
will need to secure additional funding at some point beyond the twelve month 
period referred to above to enable the Group to continue to operate in its 
current format. However, based on the success of the two fundraisings in the 
year and the proposed IPO, the Board has a reasonable expectation that it could 
secure additional funding if required. 
 
Further information is included in note 2. 
 
Financial review 
Loss 
The loss for the year decreased by 16% from GBP15,451,979 in 2008 to 
GBP13,032,359 in 2009 and the net loss per share decreased by 81% from 6.66 
pence in 2008 to 1.25 pence in 2009, significantly impacted by the 349% increase 
in the weighted average number of shares in issue in 2009.  The operating loss 
for the period decreased by 18%, primarily due to a reduction in the overall 
cost base of the business and the impact of costs incurred in 2008 in connection 
with the withdrawal of a proposed ADS issue and listing on the NASDAQ Global 
Market in the U.S., offset by the adverse impact of currency exchange rate 
differences between the two periods amounting to 11%. 
 
Revenue 
Revenue increased from GBP352,069 in 2008 to GBP638,186 in 2009.  The increase 
of GBP286,117, or 81%, was principally due to the growth in sales of our 
Warfarin Sensitivity and Cystic Fibrosis Tests, although currency exchange rate 
differences accounted for 27% of the increase.  Product sales were GBP305,163 
and GBP583,482 (an increase of 91%) and license revenues were GBP46,906 and 
GBP54,704 (an increase of 17%) in 2008 and 2009, respectively. 
 
Changes in inventories of finished goods and work in progress 
Changes in inventories of finished goods and work in progress increased from 
GBP312,106 in 2008 to GBP704,880 in 2009.  The increase of GBP392,774, or 126%, 
was principally as a result of manufacturing additional Warfarin Sensitivity and 
Cystic Fibrosis Tests in 2009, following the growth in our installed base of 
instruments. 
 
Employee benefits 
Employee benefits costs decreased from GBP6,882,569 in 2008 to GBP5,230,273. 
The decrease of GBP1,652,296, or 24%, includes an increase in the level of share 
compensation charges from a credit of GBP314,881 for 2008 to a charge of 
GBP782,636 in 2009. The increase in the share compensation charge is principally 
due to the issue of warrants in the period giving rise to a charge of 
GBP566,423. The credit in 2008 was primarily due to a revision of expectations 
for achieving performance targets for management long-term incentive plans. 
Excluding share compensation charges, other employee benefits costs were 
GBP4,447,637 in 2009 (2008 - GBP7,197,450), a reduction of GBP 2,749,813, or 
38%, reflecting the lower average number of employees in the year, which 
decreased by 42% from 110 in 2008 to 64 in 2009. 
 
Research and development costs 
Research and development costs decreased from GBP2,667,855 in 2008 to 
GBP1,815,379 in 2009, a decrease of GBP852,476, or 32%. This reduction was 
primarily due to the completion of the development of the eSensor  XT-8 System 
in 2008. 
 
Depreciation, amortization and impairment losses 
Depreciation, amortization and impairment losses increased from GBP714,637 in 
2008 to GBP2,004,064 in 2009.  The increase of GBP1,289,427, or 180%, primarily 
resulted from impairment losses of GBP527,387 from a write down of eSensor  XT-8 
instruments, following a review of cashflows expected to be generated from 
future revenues and impairment losses following a review of the future economic 
benefit expected to be derived from licenses. Depreciation in respect of eSensor 
 XT-8 instruments also increased during the period, including an additional 
depreciation charge of GBP77,514 in the year due to a revision of the expected 
useful life of instruments provided to customers under reagent rental agreements 
from 5 to 3 years. 
 
Other expenses 
In total, other expenses decreased from GBP5,383,198 in 2008 to GBP3,759,308 in 
2009.  This decrease of GBP1,623,890, or 30%, principally reflects GBP1,195,536 
costs incurred in 2008 in connection with the withdrawal of a proposed ADS issue 
and listing on the NASDAQ Global Market in the U.S. 2009. 
 
Interest on bank balances and term deposits 
Interest on bank balances and term deposits decreased from GBP213,259 in 2008 to 
GBP22,420 in 2009.  The decrease of GBP190,839, or 89%, resulted both from a 
reduction in average cash balances during the year and a significant reduction 
in average interest rates. 
 
Liquidity and Capital Resources 
Cash and cash equivalents increased from GBP6,034,926 at 31 December 2008 to 
GBP10,195,347 at 31 December 2009, an increase of GBP4,160,421, or 69%.  The 
increase of cash and cash equivalents was principally due to GBP14,836,579 net 
proceeds raised through the issue of equity, offset by net cash used in 
operating activities of GBP10,275,461. 
 
Net cash used in operating activities decreased from GBP14,305,945 in 2008 to 
GBP10,275,461, a decrease of GBP4,030,484, or 28%.  The movement was primarily 
due to a decrease in the operating loss of GBP2,732,578 and an increase of 
GBP2,386,943 in non-cash items: depreciation, amortisation, impairment losses 
and share compensation charges. 
 
Net cash used in investing activities from continuing operations decreased from 
GBP760,989 in 2008 to GBP266,309 in 2009, representing a decrease of GBP494,680, 
or 65%.  The decrease is primarily explained by a reduction in purchases of 
plant and equipment. 
 
Net cash generated from financing activities increased from GBP6,662,609 in 2008 
to GBP14,836,579 in 2009, an increase of GBP8,173,970, or 123%.  The increase 
reflects the net proceeds from the issue of shares. 
 
Jon Faiz Kayyem 
Chief Executive Officer 
19 March 2010 
 
 
Consolidated income statement for the year ended 31 December 2009 
 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |    (Audited) |        (Audited) | 
|                                | Note |  |  31 December |      31 December | 
|                                |      |  |         2009 |             2008 | 
+--------------------------------+------+--+--------------+------------------+ 
| Continuing operations          |      |  |          GBP |              GBP | 
+--------------------------------+------+--+--------------+------------------+ 
| Revenue                        |      |  |      638,186 |          352,069 | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Changes in inventories of      |      |  |              |                  | 
| finished goods and work in     |      |  |    (704,880) |        (312,106) | 
| progress                       |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Employee benefits              |      |  |  (5,230,273) |      (6,882,569) | 
+--------------------------------+------+--+--------------+------------------+ 
| Research and development costs |      |  |  (1,815,379) |      (2,667,855) | 
+--------------------------------+------+--+--------------+------------------+ 
| Depreciation, amortisation and |      |  |  (2,004,064) |        (714,637) | 
| impairment losses              |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Other expenses                 |      |  |  (3,759,308) |      (5,383,198) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  | (13,513,904) |     (15,960,365) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Operating loss                 |    3 |  | (12,875,718) |     (15,608,296) | 
+--------------------------------+------+--+--------------+------------------+ 
| Interest on bank balances and  |      |  |       22,420 |          213,259 | 
| term deposits                  |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Gains on financial instruments |      |  |            - |           65,630 | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Loss before taxation           |      |  | (12,853,298) |     (15,329,407) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Taxation                       |      |  |    (179,061) |        (122,572) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Loss for the year              |      |  | (13,032,359) |     (15,451,979) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |       __________ | 
+--------------------------------+------+--+--------------+------------------+ 
| Loss per share:                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| From continuing operations     |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
| Basic and diluted (restated)   |    4 |  |      (1.25p) |          (6.66p) | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
|                                |      |  |              |                  | 
+--------------------------------+------+--+--------------+------------------+ 
 
Consolidated statement of comprehensive income for the year ended 31 December 
2009 
 
 
+------------------------------------------+--------------+--------------+ 
|                                          |    (Audited) |    (Audited) | 
|                                          |  31 December |  31 December | 
|                                          |         2009 |         2008 | 
+------------------------------------------+--------------+--------------+ 
|                                          |          GBP |          GBP | 
+------------------------------------------+--------------+--------------+ 
|                                          |              |              | 
+------------------------------------------+--------------+--------------+ 
| Loss for the year                        | (13,032,359) | (15,451,979) | 
+------------------------------------------+--------------+--------------+ 
| Exchange differences on translation of   |    (355,346) |    1,039,827 | 
| foreign operations                       |              |              | 
+------------------------------------------+--------------+--------------+ 
|                                          |              |              | 
+------------------------------------------+--------------+--------------+ 
| Total comprehensive loss for the year    | (13,387,705) | (14,412,152) | 
+------------------------------------------+--------------+--------------+ 
|                                          |              |              | 
+------------------------------------------+--------------+--------------+ 
| Attributable to:                         |              |              | 
+------------------------------------------+--------------+--------------+ 
|   Owners of the Company                  | (13,387,705) | (14,412,152) | 
+------------------------------------------+--------------+--------------+ 
|                                          |              |              | 
+------------------------------------------+--------------+--------------+ 
|                                          |              |              | 
+------------------------------------------+--------------+--------------+ 
 
 
Consolidated balance sheet at 31 December 2009 
 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |         (Audited)          |         (Audited)          | 
|                          |            2009            |            2008            | 
+--------------------------+----------------------------+----------------------------+ 
|                          |         GBP |          GBP |         GBP |          GBP | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Assets                   |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Non current assets       |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Other intangible         |     668,629 |              |   1,379,009 |              | 
| assets                   |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Property, plant and      |     854,591 |              |   1,603,602 |              | 
| equipment                |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Current assets           |             |    1,523,220 |             |    2,982,611 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Inventories           |      84,720 |              |   1,109,008 |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Trade and other          |     592,831 |              |     812,261 |              | 
| receivables              |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Current tax assets    |           - |              |     153,793 |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Cash and cash            |  10,195,347 |              |   6,034,926 |              | 
| equivalents              |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |   10,872,898 |             |    8,109,988 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Total assets             |             |   12,396,118 |             |   11,092,599 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Liabilities              |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Current liabilities      |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Trade and other          | (1,980,315) |              | (3,047,844) |              | 
| payables                 |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Current tax              |   (168,125) |              |     (8,937) |              | 
| liabilities              |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |  (2,148,440) |             |  (3,056,781) | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Non-current liabilities  |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Provisions            |             |    (205,563) |             |    (225,212) | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Total liabilities        |             |  (2,354,003) |             |  (3,281,993) | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Net assets               |             |   10,042,115 |             |    7,810,606 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Equity                   |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Called up share          |             |    8,459,279 |             |    7,717,443 | 
| capital                  |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Share premium account |             |   71,825,053 |             |   57,730,310 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Other reserves        |             |    2,606,560 |             |    1,823,925 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Cumulative exchange      |             |      111,564 |             |      466,910 | 
| reserve                  |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|    Accumulated deficit   |             | (72,960,341) |             | (59,927,982) | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
| Total equity             |             |   10,042,115 |             |    7,810,606 | 
+--------------------------+-------------+--------------+-------------+--------------+ 
|                          |             |              |             |              | 
+--------------------------+-------------+--------------+-------------+--------------+ 
 
 
 
 
 
 
 
 
 
Consolidated statement of changes in equity 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |                 Equity attributable to equity holders of the                  | 
|                              |                                    Company                                    | 
+------------------------------+-------------------------------------------------------------------------------+ 
|                              |           |            |           |            |              |              | 
|                              |           |      Share |           | Cumulative |              |              | 
|                              |     Share |    Premium |     Other |            |     Retained |        Total | 
|                              |   Capital |    Account |   Reserve |   Exchange |     Earnings |       Equity | 
|                              |       GBP |        GBP |           |    Reserve |          GBP |          GBP | 
|                              |           |            |       GBP |        GBP |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Balance at 1 January 2008    |           |            |           |            |              |              | 
|                              | 7,028,892 | 51,756,252 | 2,138,806 |  (572,917) | (44,476,003) |   15,875,030 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Loss for the year            |         - |          - |         - |          - | (15,451,979) | (15,451,979) | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Other comprehensive income   |           |            |           |            |              |              | 
| for the year                 |         - |          - |         - |  1,039,827 |            - |    1,039,827 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Total comprehensive          |           |            |           |            |              |              | 
| income/(loss) for the period |         - |          - |         - |  1,039,827 | (15,451,979) | (14,412,152) | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Issue of share capital       |   688,551 |  5,974,058 |           |            |              |    6,662,609 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Debit to equity for          |           |            |           |            |              |              | 
| equity-settled share based   |         - |          - | (314,881) |          - |            - |    (314,881) | 
| payments                     |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Balance at 31 December 2008  |           |            |           |            |              |              | 
|                              | 7,717,443 | 57,730,310 | 1,823,925 |    466,910 | (59,927,982) |    7,810,606 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Loss for the year            |         - |          - |         - |          - | (13,032,359) | (13,032,359) | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Other comprehensive loss for |           |            |           |            |              |              | 
| the year                     |         - |          - |         - |  (355,346) |            - |    (355,346) | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Total comprehensive loss for |           |            |           |            |              |              | 
| the year                     |         - |          - |         - |  (355,346) | (13,032,359) | (13,387,705) | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Issue of share capital       |   741,836 | 14,094,743 |         - |          - |            - |   14,836,579 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Credit to equity for         |           |            |           |            |              |              | 
| equity-settled share based   |         - |          - |   782,635 |          - |            - |      782,635 | 
| payments                     |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
| Balance at 31 December 2009  |           |            |           |            |              |              | 
|                              | 8,459,279 | 71,825,053 | 2,606,560 |    111,564 | (72,960,341) |   10,042,115 | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
|                              |           |            |           |            |              |              | 
+------------------------------+-----------+------------+-----------+------------+--------------+--------------+ 
 
 
Consolidated cash flow statements for the year ended 31 December 2009 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |    (Audited) |    (Audited) | 
|                                   |      |         2009 |         2008 | 
|                                   | Note |          GBP |          GBP | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Net cash used in operating        |  (a) | (10,275,461) | (14,305,945) | 
| activities                        |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Net cash used in investing        |  (c) |    (266,309) |    (760,989) | 
| activities                        |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Net cash generated from financing |  (c) |   14,836,579 |    6,662,609 | 
| activities                        |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Net increase / (decrease) in cash |      |    4,294,809 |  (8,404,325) | 
| and cash equivalents              |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Cash and cash equivalents at      |      |    6,034,926 |   13,910,710 | 
| beginning of year                 |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Effect of foreign exchange rate   |      |    (134,388) |      528,541 | 
| changes                           |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
| Cash and cash equivalents at end  |      |   10,195,347 |    6,034,926 | 
| of year                           |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
|                                   |      |              |              | 
+-----------------------------------+------+--------------+--------------+ 
Notes to the Cash Flow Statements 
(a) Reconciliation of loss for the year to net cash outflow from operating 
activities 
 
+-----------------------------------------+--------------+--------------+ 
|                                         | Consolidated | Consolidated | 
|                                         |         2009 |         2008 | 
|                                         |          GBP |          GBP | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Loss for the year                       | (13,032,359) | (15,451,979) | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Adjustments for:                        |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Depreciation of property, plant and     |      896,194 |      584,795 | 
| equipment                               |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Amortisation of other intangible assets |      190,299 |      129,842 | 
+-----------------------------------------+--------------+--------------+ 
| Loss on disposal of property, plant and |        4,210 |       20,591 | 
| equipment                               |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Impairment losses                       |      917,571 |            - | 
+-----------------------------------------+--------------+--------------+ 
| Share compensation charge / (credit)    |      782,635 |    (314,881) | 
+-----------------------------------------+--------------+--------------+ 
| Interest on bank balances and term      |     (22,420) |    (213,259) | 
| deposits                                |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Income tax                              |      179,061 |      122,572 | 
+-----------------------------------------+--------------+--------------+ 
| (Decrease) / increase in provisions     |     (19,649) |       54,117 | 
+-----------------------------------------+--------------+--------------+ 
| Movement in fair value of financial     |            - |     (65,630) | 
| instruments                             |              |              | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Operating cash outflow before movements | (10,104,458) | (15,133,832) | 
| in working capital                      |              |              | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Decrease / (increase) in inventories    |      658,712 |    (503,530) | 
+-----------------------------------------+--------------+--------------+ 
| Decrease / (increase) in receivables    |    (109,007) |    (235,783) | 
+-----------------------------------------+--------------+--------------+ 
| (Decrease) / increase  in payables      |    (848,098) |    1,355,149 | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Cash used in operations                 | (10,402,851) | (14,517,996) | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Income taxes received                   |      127,390 |      212,051 | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
| Net cash used in operating activities   | (10,275,461) | (14,305,945) | 
+-----------------------------------------+--------------+--------------+ 
|                                         |              |              | 
+-----------------------------------------+--------------+--------------+ 
 
. 
(b) Major non-cash transactions 
 
There were no major non cash transactions in the years ended 31 December 2008 
and 31 December 2009. 
(c)  Analysis of cash flows - Gross cash flows 
+--------------------------------------------+------------+-------------+ 
|                                            |       2009 |        2008 | 
|                                            |        GBP |         GBP | 
+--------------------------------------------+------------+-------------+ 
| Investing activities                       |            |             | 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
| Interest received                          |     22,420 |     218,505 | 
+--------------------------------------------+------------+-------------+ 
| Purchases of property, plant and equipment |  (295,938) | (1,089,784) | 
+--------------------------------------------+------------+-------------+ 
| Receipts from the sale of intangible fixed |          - |     102,606 | 
| assets                                     |            |             | 
+--------------------------------------------+------------+-------------+ 
| Receipts from the sale of tangible fixed   |      7,209 |       7,684 | 
| assets                                     |            |             | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
| Net cash used in investing activities      |  (266,309) |   (760,989) | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
| Financing activities                       |            |             | 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
| Proceeds on issues of shares (net)         | 14,836,579 |   6,662,609 | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
| Net cash generated from financing          | 14,836,579 |   6,662,609 | 
| activities                                 |            |             | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
|                                            |            |             | 
+--------------------------------------------+------------+-------------+ 
1.       Results 
 
The financial information set out in the announcement does not contribute the 
company's statutory accounts for the year ended 31 December 2008 or 2009. 
 
The financial information for the year ended 31 December 2008 is derived from 
the statutory accounts for that year which have been delivered to the Registrar 
of Companies. The auditors have reported on those accounts; their report was 
modified by the inclusion of an emphasis of matter paragraph which highlighted 
the existence of a material uncertainty that cast significant doubt on the 
Company's and Group's ability to continue as a going concern; their report was 
unqualified and did not contain a statement under s498(2) or (3) Companies Act 
2006 or equivalent preceding legislation. 
 
The statutory accounts for the year ended 31 December 2009 will be delivered 
following the company's annual general meeting. The auditors have reported on 
those accounts; their report was unqualified, did not draw attention to any 
matters by way of emphasis and did not contain statements under s498(2) or (3) 
Companies Act 2006. 
 
The financial statements of the Group have been prepared in accordance with 
International Financial Reporting Standards (IFRS) as adopted for use in the 
European Union. Whilst the financial information included in this preliminary 
announcement has been computed in accordance with IFRS, this announcement does 
not itself contain sufficient information to comply with IFRS. The Company 
expects to publish full financial statements that comply with IFRS in June 2010. 
 
2.       Going concern 
 
As disclosed in the Chairman's statement, it is proposed that pursuant to a 
Scheme of arrangement Osmetech will become a wholly owned subsidiary of GenMark 
Diagnostics, Inc. ("GenMark").  GenMark plans to make an initial public offering 
(IPO) and it is proposed that up to $40.3 million will be raised through the 
IPO. However, as the Scheme of arrangement and the fundraising are not certain, 
these potential new funds have not been taken into consideration in making the 
assessment of whether it is appropriate to prepare the financial statements on a 
going concern basis. 
 
The Group's Directors have prepared a detailed cash flow forecast for the period 
ending 31 March 2011 ("the forecast") which includes a number of assumptions 
regarding income, expenditure, cash flows and the availability of future finance 
for the Group. The forecasts also take into consideration the $4m (GBP2.5m) debt 
facility which comprises a $2m (GBP1.25m) line of credit facility linked to 
eligible receivables and $2m (GBP1.25m) to finance certain forecast capital 
expenditure that is available until 12 July 2011. 
 
Given the nature of the Group's business and the industry, it is inherently 
difficult to accurately forecast the timing of these events and the associated 
subsequent cash flows. The Directors have therefore performed a sensitivity 
analysis in order to consider the impact upon cash flows if revenues are lower 
than forecast or 'non-controllable' costs exceed forecast. If such circumstances 
prevail, the Directors have identified further cost savings and efficiencies 
that they can implement to further reduce the cost base and cash outflows if 
they consider it necessary to do so and in the best interests of the business. 
As a result, the Directors believe that they have sufficient discretion and 
control over the quantum and timing of cash-outflows, for example by 
implementing further, identified, cost saving programs to ensure that the Group 
is able to meet its liabilities as they fall due for at least twelve months from 
the date of these financial statements. 
 
Consistent with other companies of a similar size in this sector, the Board are 
aware that they will need to secure additional funding to enable it to continue 
to execute its business strategy beyond the next twelve months. If additional 
funds are not raised, the Board will have to take significant actions to reduce 
its cash burn which will reduce its ability to develop or sustain its 
operations. However, based on the success of the two fundraisings in the year, 
previous fundraisings, and the IPO plans noted above, the Board have a 
reasonable expectation that it could secure additional funding if required and 
that these actions will not have to be taken. 
 
In conclusion, taking into account all the factors mentioned above, the 
Directors believe that they have a reasonable expectation that the Group will be 
able to operate within its available resources and there will be sufficient 
funds to enable the Group to continue as a going concern for the foreseeable 
future. 
 
3.       Operating loss 
 
The following items are charged/(credited) in arriving at the Group's operating 
loss from continuing operations. 
 
+-------------------------------------------------+-----------+-----------+ 
|                                                 |      2009 |      2008 | 
+-------------------------------------------------+-----------+-----------+ 
|                                                 |       GBP |       GBP | 
+-------------------------------------------------+-----------+-----------+ 
| Amortisation of intangible assets               |   190,299 |   129,842 | 
+-------------------------------------------------+-----------+-----------+ 
| Depreciation                                    |   896,194 |   584,795 | 
+-------------------------------------------------+-----------+-----------+ 
| Impairment of intangible assets                 |   390,184 |         - | 
+-------------------------------------------------+-----------+-----------+ 
| Impairment of tangible assets                   |   527,387 |         - | 
+-------------------------------------------------+-----------+-----------+ 
| Fees payable to the Company's auditors for the  |           |           | 
| audit of the:                                   |           |           | 
+-------------------------------------------------+-----------+-----------+ 
| -                                               |    51,500 |    40,921 | 
| Company's annual accounts                       |           |           | 
+-------------------------------------------------+-----------+-----------+ 
| -                                               |    49,985 |    24,575 | 
| Company's subsidiaries pursuant to legislation  |           |           | 
+-------------------------------------------------+-----------+-----------+ 
| Fees payable to the Company's auditors for      |           |           | 
| other services to the Group:                    |           |           | 
+-------------------------------------------------+-----------+-----------+ 
| - Tax                                           |    91,863 |    58,570 | 
| services                                        |           |           | 
+-------------------------------------------------+-----------+-----------+ 
|          - Other services                       |    66,250 |   273,000 | 
+-------------------------------------------------+-----------+-----------+ 
| Operating lease rentals - plant and machinery   |    15,979 |    13,587 | 
+-------------------------------------------------+-----------+-----------+ 
| Research and development                        | 1,815,379 | 2,667,855 | 
+-------------------------------------------------+-----------+-----------+ 
| Loss on disposal of property, plant and         |     4,210 |    20,591 | 
| equipment                                       |           |           | 
+-------------------------------------------------+-----------+-----------+ 
| Staff costs                                     | 5,230,273 | 6,882,569 | 
+-------------------------------------------------+-----------+-----------+ 
| Net foreign exchange gains                      | (202,003) | (228,023) | 
+-------------------------------------------------+-----------+-----------+ 
| Cost of inventories recognised as expense       |   704,880 |   880,206 | 
+-------------------------------------------------+-----------+-----------+ 
|                                                 |           |           | 
+-------------------------------------------------+-----------+-----------+ 
 
Included within the other operating costs are costs of GBP936,885 in respect of 
professional fees (2008 - GBP2,463,155). This includes GBPnil (2008 - 
GBP1,195,536) incurred in connection with the withdrawal of a proposed issue and 
listing of American Depositary Shares on the NASDAQ Global Market in the USA. 
 
Fees payable to the company's auditors for other services to the Group represent 
accounting advice in connection with proposed listings on NASDAQ. 
 
 
4.       Loss per share 
+------------------------------------------------+--------------+--------------+ 
|                                                |         Year |         Year | 
|                                                |        ended |        ended | 
|                                                |           31 |           31 | 
|                                                |     December |     December | 
|                                                |         2009 |         2008 | 
|                                                |          GBP |          GBP | 
+------------------------------------------------+--------------+--------------+ 
|                                                |              |              | 
| Loss for the year attributable to equity       | (13,032,359) | (15,451,979) | 
| holders of the Company                         |              |              | 
+------------------------------------------------+--------------+--------------+ 
|                                                |              |              | 
+------------------------------------------------+--------------+--------------+ 
|                                                |         2009 |         2008 | 
+------------------------------------------------+--------------+--------------+ 
|                                                |        Pence |        pence | 
+------------------------------------------------+--------------+--------------+ 
|                                                |              |   (restated) | 
+------------------------------------------------+--------------+--------------+ 
| Loss per share                                 |              |              | 
+------------------------------------------------+--------------+--------------+ 
| Basic and diluted                              |       (1.25) |       (6.66) | 
+------------------------------------------------+--------------+--------------+ 
|                                                |              |              | 
+------------------------------------------------+--------------+--------------+ 
 
Basic loss per share is calculated by dividing the loss for the financial year 
attributable to equity holders by 1,041,154,350 (2008 - 231,928,699), being the 
weighted average number of shares in issue during the year. The weighted average 
number of shares in issue in 2008 originally reported was 222,889,207 and has 
now been adjusted for a calculation error. As a result of this, the loss per 
share in 2008 has been adjusted from 6.93 pence to 6.66 pence. 
 
As the Group reported a loss for the year, all potential shares relating to 
share options and warrants are viewed as antidilutive.  The number of potential 
dilutive ordinary shares as at 31 December 2009 was 279,221,327 (2008 - 
24,975,790). 
 
 
 
This information is provided by RNS 
            The company news service from the London Stock Exchange 
   END 
 
 FR UKONRRWAOARR 
 

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