TIDMODX
RNS Number : 6304M
Omega Diagnostics Group PLC
17 October 2016
Omega Diagnostics Group PLC
("Omega" or "the Company")
Trading Update and Notice of Interim Results
Omega (AIM: ODX), the medical diagnostics company focused on
allergy, food intolerance and infectious disease, announces the
following trading update for the six months to 30 September 2016,
in advance of releasing its interim results on Monday, 21 November
2016.
Financial update
Turnover is expected to be GBP6.83m, 3% ahead of last year's
first half in constant currency terms and 11% ahead of last year's
result (30 September 2015: GBP6.15m) on an actual basis, reflecting
the weakening of sterling against the US dollar and euro throughout
the period. Profit before tax (before share based payments,
IFRS-related discount unwinds and amortisation of intangible
assets) is in line with management's expectation at the half-year
stage.
Segmental revenues are expected to be as follows:
Revenue to Revenue to % increase
30 September 30 September
2016 2015
Food Intolerance GBP3.84m GBP3.34m + 15%
Allergy/Autoimmune GBP1.76m GBP1.59m + 11%
Infectious Disease/Other GBP1.23m GBP1.22m + 1%
TOTAL GBP6.83m GBP6.15m + 11%
Core business update
Food Intolerance
We continue to see real growth in revenue on a constant currency
basis, supplemented by currency related gains. We have seen
particularly strong growth in North America with our
microarray-based Foodprint(R) test which includes significant
organic growth with one key customer and another new customer win
which offers large potential.
Allergy/Autoimmune
Revenue in the first half of the current financial year was
stable on a constant currency basis in our German domestic
business, compared to the previous period. After recent years of
decline in revenue due to reimbursement pressures, it is
encouraging that this trend has been arrested in the current
period. The weakening of sterling against the euro has led to an
increase in revenue reported above.
Infectious Disease
This segment continues to be the most price-competitive in which
we operate with gains in some regions being offset by regional
reductions elsewhere. A small percentage reduction in revenue in
actual terms has been positively impacted by the weaker position of
sterling, as noted above.
Allergy development - IDS-iSYS automation update
At the end of last week, we held the pre-launch design meeting
to review the technical files, labelling, external evaluation
results and all the product claims for the launch panel of 41
allergens. It is particularly pleasing to report that the outcome
from this meeting is that we have now CE-Marked all 41 allergens
and a full inventory of these allergen tests are now available for
sale. We have received a first purchase order for product from one
end-user customer and we aim to fulfil this once we conclude a
long-term supply contract with them in the very near future. We are
also continuing to advance discussions with IDS over the longer
term supply of allergy tests on a wider basis.
As previously reported in August, we secured a Scottish
Enterprise research and development grant of GBP1.8 million and
this has enabled us to accelerate recruitment of skilled project
managers and leaders into the scientific team that is responsible
for delivering menu expansion, beyond the initial launch panel.
This will ensure that we enhance our product offering on a
continuous basis.
Infectious Disease
CD4 update
At the time of the last update on 27 June 2016, we had selected
a test design which showed no ambient temperature effect ("ATE"),
over the range 20-35degC, when tested on in-house samples. Since
then, we have tested the design at varying temperatures on over 100
HIV-positive samples at a UK hospital and we have confirmed no
evidence of ATE over several weeks of testing, which mirrors our
in-house testing reported previously.
In addition, over 400 HIV-positive samples have been tested by
non-Omega staff at two further UK sites and the data from all three
sites is within expectation and has demonstrated a similar
relationship between the Visitect(R) test result and the recognised
gold standard test of flow cytometry. The test results from these
500+ patients also indicate that our design goal parameters for
sensitivity and specificity can be met on a visual interpretation
of the Visitect(R) test result.
Accordingly, the product has reached a key milestone whereby we
have now entered formal design control. To support this process, we
have recently recruited an experienced project manager who is now
leading this selected test design through optimisation to ensure we
can achieve manufacturing robustness and scalability. Thereafter,
we plan to manufacture batches of devices for external field trials
and to complete the claim support work required for CE-Marking.
Rapid test manufacturing
In September 2016, the manufacturing facility in Pune, India
underwent a final factory inspection, the outcome of which was a
recommendation that we be issued with a final factory licence from
the Maharashtra State Government which allows the facility to
operate as a commercial production unit. We have also undergone a
Stage-1 BSI Quality Management System review of all our
manufacturing documentation for ISO 9001:2008 and ISO 13485:2012.
This will be followed by an implementation review Stage-2
assessment, followed by a final external audit assessment by BSI
over the next few weeks. We remain on course to bring this facility
on line with CE-Marked malaria and pregnancy tests available for
sale in the final quarter of the current financial year.
As a result of this encouraging progress we will pre-launch the
malaria product range at the forthcoming meeting of the American
Society of Tropical Medicine and Hygiene in Atlanta in November,
which is the largest international scientific organisation of
experts dedicated to reducing the worldwide burden of tropical
infectious diseases and improving global health.
We believe our increased investment in infrastructure to support
our core business and development opportunities provides a stronger
foundation for the future.
Outlook
First half trading performance is in line with management's
expectation, with revenue ahead of last year on a like-for-like
basis, supplemented by a gain of GBP0.5m in the period due a weaker
sterling exchange rate compared to the prior period.
We have made significant progress with our chosen Visitect(R)
CD4 test design and we now have a stronger team with a clearer
roadmap to complete the technical work needed to achieve launch and
we remain confident of delivering a product that meets a large
unmet need in the global health community.
We continue to see opportunities for our Food Intolerance
division in the North American market and are actively pursuing a
number of exciting prospects in what is an attractive
consumer-driven market.
We have CE-Marked our launch panel of Allersys(R) reagents and
we are now completing our first commercial contract and pursuing a
growth strategy for longer term competitiveness in this field.
Finally, we have made significant progress in bringing our Pune
facility to a state of readiness so that it may begin to generate a
commercial return by the end of the current financial year.
Andrew Shepherd, Chief Executive Officer of the Company
commented: "We are pleased with the positive progress that has been
made in our key business areas and are looking to the future with
increased confidence regarding commercialisation of CD4, the
Allersys programme and the Malaria product range."
The information communicated in this announcement is inside
information for the purposes of Article 7 of EU Regulation
596/2014.
Contacts:
Omega Diagnostics Group PLC Tel: 01259 763 030
Andrew Shepherd, Chief Executive www.omegadiagnostics.com
Kieron Harbinson, Group Finance
Director
Jag Grewal, Group Sales and Marketing
Director
finnCap Ltd Tel: 020 7220 0500
Geoff Nash/James Thompson (Corporate
Finance)
Mia Gardner (Corporate Broking)
Walbrook PR Limited Tel: 020 7933 8780 or omega@walbrookpr.com
Paul McManus Mob: 07980 541 893
Lianne Cawthorne Mob: 07584 391 303
This information is provided by RNS
The company news service from the London Stock Exchange
END
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