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
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