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ODX Omega Diagnostics Group Plc

2.20
0.00 (0.00%)
24 Apr 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type Share ISIN Share Description
Omega Diagnostics Group Plc LSE:ODX London Ordinary Share GB00B1VCP282 ORD 4P
  Price Change % Change Share Price Bid Price Offer Price High Price Low Price Open Price Shares Traded Last Trade
  0.00 0.00% 2.20 2.00 2.40 0.00 01:00:00
Industry Sector Turnover Profit EPS - Basic PE Ratio Market Cap
0 0 N/A 0

Omega Diagnostics Group PLC Final Results (6666J)

30/06/2017 7:01am

UK Regulatory


Omega Diagnostics (LSE:ODX)
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TIDMODX

RNS Number : 6666J

Omega Diagnostics Group PLC

30 June 2017

30 June 2017

OMEGA DIAGNOSTICS GROUP PLC

("Omega" or the "Company" or the "Group")

FINAL RESULTS

FOR THE YEARED 31 MARCH 2017

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces its audited results for the year ended 31 March 2017.

Omega is one of the UK's leading companies in the fast growing area of food intolerance, operating in markets supplying tests for allergies and autoimmune diseases as well as specific infectious diseases. The Company is able to do this through a strong distribution network in over 100 countries, a direct presence in Germany and India, and with a growing network of global partnerships.

Financial Highlights:

   --      Turnover up 12% to GBP14.2m (2016: GBP12.7m) 
   --      Food intolerance revenue up 13% to GBP8.00m (2016: GBP7.06m) 
   --      Allergy and autoimmune revenue up 14% to GBP3.59m (2016: GBP3.16m) 
   --      Infectious disease/other revenue up 5% to GBP2.66m (2016: GBP2.52m) 
   --      Gross profit up 13% to GBP9.2m (2016: GBP8.1m) 
   --      Adjusted profit before tax* of GBP1.13m (2016: GBP1.35m) 
   --      Adjusted EPS 1.1p (2016: 1.2p) 
   --      Cash at the period end of GBP0.74m (2016: GBP1.30m) 

* Adjusted for amortisation of intangible assets, share based payment charges and IFRS-related discount charges

Operational Highlights:

-- Scottish Enterprise grant funding of GBP1.8 million secured towards planned expansion of Allersys menu

   --      CE-mark achieved for 41 allergens to run on IDS-iSYS platform 
   --      CE-mark achieved for VISITECT(R) malaria tests to be manufactured at our facility in Pune 
   --      Four new Allergodip(R) panels now optimised 
   --      Formal design freeze attained with our VISITECT(R) CD4 test 
   --      Recruitment of skilled project managers and leaders into scientific teams 

Commenting, David Evans, Chairman, said:

"We are encouraged that trading in the first quarter of the new financial year is in line with our expectations.

"CD4 testing remains a practical and necessary marker for assessment of the baseline status of HIV infection. We are confident that we will meet the remaining challenges within the validation programme that will determine our ability to manufacture a product at scale which meets the market's need.

"As separately notified today, we have announced a placing and open offer to secure funding to ensure that a number of organic growth opportunities can be exploited across all three of our segments in terms of market expansion, manufacturing expansion and product line extensions. We believe this will provide us with a solid foundation for future growth in shareholder value."

 
 Omega Diagnostics Group                                    Tel: 01259 763 030 
  PLC 
 Andrew Shepherd, Chief Executive 
 Kieron Harbinson, Group                              www.omegadiagnostics.com 
  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 
 

Chairman's Statement

Strategy

Point-of-care (POC) testing

VISITECT(R) CD4

We achieved a significant milestone in attaining formal design freeze with our VISITECT(R) CD4 test for monitoring the immune status of people living with HIV following the successful manufacture of three pilot batches. Devices from these batches were tested at three UK hospital sites, on sufficient numbers of patient samples to demonstrate that we now have a method for manufacturing devices which consistently meets our design goal specifications regarding sensitivity and specificity.

We have now moved into the validation and verification phase of the programme which can be summarised across the following activities:

   --      manufacturing of validation batches to confirm manufacturing robustness/reproducibility; 
   --      utilising validation batches to verify performance; 
   --      external performance evaluation trials; and 
   --      CE mark. 

We have selected two sites in the UK and one site in India to undertake evaluation studies. This is an important phase in the project and we will give ourselves sufficient time to demonstrate that we can transfer the product from development to routine manufacturing.

We continually assess the market landscape for this product and it seems clear that there is an increasing emphasis on the continued need for monitoring CD4 levels in people living with HIV, particularly those patients with low CD4 counts who are at significant risk of contracting opportunistic infections. The Company has built up relationships with a number of key opinion leaders over the years and so we have a voice that enables us to input into key stakeholder meetings. We have been invited to attend the ninth International AIDS Society Conference on HIV Science (IAS 2017) to be held in Paris in late July where VISITECT(R) CD4 will be showcased.

Pune manufacturing facility

We made a significant amount of progress during the year with our manufacturing facility in Pune, India.

In January, we announced that we received certificates of accreditation from BSI confirming our Quality Management System is compliant with ISO 9001:2008 and ISO 13485:2003. In March, we confirmed the facility underwent an annual inspection from the Indian FDA, confirming that the facility is compliant with GMP processes for manufacturing, testing, storage and QA, and that we were issued with a manufacturing licence which is valid until January 2021.

We also announced that we were successful in CE-marking and launching our VISITECT(R) range of malaria tests comprising:

   --      VISITECT(R) Malaria Pf (detection of HRP2 antigen in P. falciparum); 

-- VISITECT(R) Malaria Pf/Pan (detection of P. falciparum, non-P. falciparum or mixed infections); and

   --      VISITECT(R) Malaria Pf/Pv (detection and differentiation of P. falciparum and P. vivax). 

These products are currently available for general sale through business-to-business channels in those countries which do not require individual product registration and we are in the process of being evaluated for additional regulatory approvals to enable the Company to participate in higher volume tender business.

We are also in the process of evaluating additional rapid tests for dengue, syphilis, leptospirosis, brucella and S. typhi.

Allergy automation

In October last year, we reported that we CE-marked our initial Allersys(R) launch panel comprising 41 allergens. Since October, we have optimised a further 11 allergens and these are currently undergoing their claim support work, which should enable us to add them to the menu of tests available for sale. Two initiatives will help support the ongoing work to extend the menu beyond the initial launch panel, ensuring we enhance our product offering on a continuous basis. Firstly, in August last year, 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. Secondly, we have invested in creating our own in-house protein purification capability which will help in the optimisation programme of certain allergens that require a higher degree of characterisation to match the performance of the market leader.

Our commercialisation objectives are closely aligned with our partner company, Immunodiagnostic Systems Holdings plc ('IDS'), which is the manufacturer of the automated instrument over which we have exclusive rights to develop and sell our allergy tests. We have explored a number of routes in the last year on how best to take the partnership forward. Whilst IDS previously expressed an interest in acquiring the allergy business, we both subsequently concluded that our mutual objectives were better served with an enlarged distribution model. I believe we have now agreed the main outline terms which should enable the formal contract negotiations to proceed and we thank shareholders for their patience during this process.

Core business

Our core business is divided into our three main areas of operation comprising:

   --      Food intolerance; 
   --      Allergy and autoimmune; and 
   --      Infectious disease. 

Our strategic aims are to ensure that we can drive good growth across all three sectors in a way that achieves a balance such that we are not over-reliant on any single sector. I have already outlined initiatives that support growth in Allergy and autoimmune and Infectious disease.

We believe there are further significant opportunities for growth in Food intolerance and have made progress in North America, where customers are evaluating our products. In China, we are in advanced discussions with a partner company which could provide access to a large market which is increasingly aware of Food intolerance testing products and services.

In relation to our Food Detective(R) product, the Company has been in discussions this year with our notified body, Lloyds Register Quality Assurance ("LRQA") regarding use of the self-test version of the kit. The Company has agreed a timescale to complete some corrective actions to LRQA's satisfaction. In the event that we are unable to achieve this, the CE-mark for the self-test kit will be suspended for a period of time which would have a modest impact on revenues and profits.

Financial performance

Group revenue grew by 12% to GBP14.2 million (2016: GBP12.7 million) with growth in revenue across all three business sectors. As a predominantly export business, we benefited from a weaker sterling throughout the year, which added GBP1.1 million to reported revenues (2016: GBP0.2 million). On a constant currency basis, revenue would have been ahead of last year by 3%. Gross profit increased to GBP9.2 million (2016: GBP8.1 million), with an increase in gross profit margin to 64.7% (2016: 63.8%). Adjusted profit before tax (statutory profit before tax of GBP0.7 million with add backs for amortisation of intangible assets, share-based payment charges and IFRS-related discount charges) was GBP1.1 million (2016: GBP1.3 million) and adjusted earnings per share were 1.1 pence (2016: 1.2 pence), the small reduction reflecting an increase in overhead expenditure compared to the previous year. Statutory earnings per share were 0.7 pence (2016: 0.5 pence).

The Group's cash position at the year end was GBP0.7 million (2016: GBP1.3 million), which represented a neutral cash flow in the second half of the financial year. We continue to monitor our working capital management in the conversion of adjusted operating profit (operating profit excluding share-based payments and amortisation of intangible assets) into operating cash and the conversion factor for the year was 171% (2016: 108%).

Corporate governance

The size and structure of the Board and its Committees are kept under review to ensure an appropriate level of governance operates throughout the year. The Board is comprised of two Non-Executive Directors and four Executive Directors who meet frequently during the year to discuss strategy and to review progress and outcomes against objectives. Board reports containing KPIs, which report on business issues by exception, are circulated in advance of each Board meeting, which contribute to a more efficient Board process allowing sufficient time to consider business-critical issues. The Group is not required to comply with the full requirements of the UK Corporate Governance Code (as an AIM-quoted company) but we believe the Board has the skills and the necessary experience to deliver on its plans and objectives in a way that enables Non-Executive members of the Board to challenge and advise the Executive team as appropriate.

The Audit Committee and the Remuneration Committee are comprised of the two Non-Executive Directors and the Board believes the current make-up and the number of Committees remain appropriate for a group of our size.

Board and employees

There has been no change to the composition of the Board throughout the year. Employees remain a key part of our Group's success and we have introduced new training programmes for our managers and supervisors to enable them to develop themselves to the best of their ability. Wherever possible, we seek to fill new roles in the organisation with internal candidates and we have been able to promote a number of people in the year.

The Group now has 180 employees around the world and I thank them for their hard work and efforts which have achieved much progress on a number of fronts this year.

Outlook

We are encouraged that trading in the first quarter of the new financial year is in line with our expectations. We have made a significant amount of progress with a number of key assets that will underpin future growth:

   --      Allersys(R) reagents are now CE-marked with the menu continuing to grow; 
   --      VISITECT(R) CD4 has achieved design freeze; 
   --      manufacturing facility in Pune, India, is now fully validated; and 
   --      VISITECT(R) Malaria has now been CE-marked. 

Since December last year, the Company has been seeking to agree global distribution terms with its Allersys licensor, IDS. The Company believes that it has made good progress and the directors believe that once we get beyond the contractual process, the sales and marketing teams of both organisations will be capable of making a success of the Company's allergy products.

CD4 testing remains a practical and necessary marker for assessment of the baseline status of HIV infection. We are confident that we will meet the remaining challenges within the validation programme that will determine our ability to manufacture a product at scale which meets the market's need.

As separately notified today, we have announced a placing and open offer to secure funding to ensure that a number of organic growth opportunities can be exploited across all three of our segments in terms of market expansion, manufacturing expansion and product line extensions. We believe this will provide us with a solid foundation for future growth in shareholder value.

David Evans

Non-Executive Chairman

Chief Executive's Review

Dear fellow shareholder

During the year we have made great progress on our three-year vision and are now well positioned to deliver the key aim of accelerated growth in all three business divisions.

Food intolerance

-- Expansion of Foodprint(R) in key market segments is going to plan with new accounts expected to start delivering significant revenue streams over the next few years. Our R&D team in Ely are also making great strides in terms of implementing process improvements to allow us to handle the increasing demand and deliver key improvements to our customers.

-- Partners in China have been identified and work on the lengthy registration process will commence in this financial year.

Allergy and autoimmune

-- Allersys(R) - 41 allergens CE-marked and we are making substantial progress with the next phase of development with a further eleven allergens optimised. We believe we have now agreed the main outline terms which should enable the formal contract negotiations with IDS to proceed.

-- Allergodip(R) - four new panels have now been optimised and ongoing work continues with the development of a mobile phone app ahead of the initial launch of panels later this year.

Infectious disease

-- VISITECT(R) CD4 - Achieved our key milestone of design freeze by the end of March 2017 and it has now entered the validation and verification phase which is currently progressing to plan.

-- Pune facility has CE-marked three malaria rapid tests and first commercial sales in both India and export have been achieved. This is a great example of everyone involved in the project - from India, South Africa and the UK - all working together to achieve the project goals.

Core business

Segmental revenue performance

Food intolerance

The Food intolerance division has again performed well, producing double-digit growth. For this year, total Food intolerance sales increased by 13% to GBP8.00 million (2016: GBP7.06 million).

Sales of Food Detective(R) reduced by 10% in the year to GBP2.06 million (2016: GBP2.29 million). As noted in the half-year results, we took a conscious decision to reduce pipeline stocking in two of our key markets.

Sales of Genarrayt(R) /Foodprint(R) reagents grew by 34% to GBP4.67 million (2016: GBP3.47 million), with strong performances in Europe, North America and the Middle East. The Group sold a further eight instruments in the year, taking the cumulative number of installations to 176 instruments in 40 countries, and revenue per instrument (excluding Spain) increased by 29% to GBP23,442 (2016: GBP18,175). The higher percentage growth rate of reagent sales (as compared to the overall growth in revenue per instrument) reflects the investment that was made into newer North American and Southeast Asian markets in the previous year and these markets are seen as an increasingly important area for long-term growth.

Our CNS laboratory service showed an increase of 7% in sales to GBP0.62 million (2016: GBP0.58 million). Sales were still dominated by the markets in the UK and Ireland and we produced and sold 7,167 patient reports in the year (2016: 7,008), maintaining an average price of GBP86.44 per report (2016: GBP82.73).

Food intolerance will continue to be a key growth driver and contributor to the bottom line. This has been reflected in the increase in operational and marketing resource to provide high level scientific and technical support for the CNS product range. The growth trajectory is expected to continue, with this core business supported by increasing the range of products and services in the health and well-being market, which now extends to 80 countries.

Allergy and autoimmune

Sales for the Allergy and autoimmune division are comprised of Allergy sales of GBP3.03 million (2016: GBP2.57 million) and sales of Autoimmune products of GBP0.56 million (2016: GBP0.59 million), an overall increase of 14%. The Allergy sales continue to be derived almost exclusively from our Omega Diagnostics GmbH business in Germany, where our domestic sales increase of 3% in euro terms is a positive contrast to a recent history of decline due to reimbursement pressures. In reported sterling terms, the increase was 15% due to the weakening of sterling against the euro throughout the period.

Allergy development

Following the CE-marking of 41 allergens in October 2016 we have continued to develop further tests to increase the available menu. A further 11 allergens have been optimised, so we are on target to deliver another 20 allergens this year.

In addition to the Allersys(R) programme, the Allergodip(R) development pipeline has now been extended with the addition of four new panels. The introduction of a mobile phone app that allows quantification of the test result will assist in the marketing of the test to resource-poor countries with limited laboratory facilities.

Infectious disease

Infectious disease sales increased by 5% to GBP2.65 million (2016: GBP2.52 million) with the increase due to the weakening of sterling against the euro and dollar throughout the period.

We were pleased to announce the launch of the VISITECT(R) Malaria range of rapid diagnostic tests:

   --      VISITECT(R) Malaria Pf (detection of HRP2 antigen in P. falciparum); 

-- VISITECT(R) Malaria Pf/Pan (detection of P. falciparum, non-P. falciparum or mixed infections); and

   --      VISITECT(R) Malaria Pf/Pv (detection and differentiation of P. falciparum and P. vivax). 

In the development of the VISITECT(R) Malaria range we have a defined strategy to provide affordable but high quality tests that are designed with the user in mind. The devices are easy to use and come equipped with all the necessary components to run the tests effectively at the point-of-care. The range is generating good interest via business-to-business channels and at the same time we continue to work on in-country product registrations and successfully achieving global regulatory standards that will enable us to include the range in high volume public sector tender exercises.

In addition to the malaria rapid tests we are also evaluating additional rapid tests for dengue fever, syphilis, leptospira, brucella and S. typhi.

Global health update

The past year has seen significant progress in the development of VISITECT(R) CD4, the world's first semi-quantitative, instrument-free rapid test for assessing CD4 baseline status in people living with HIV. Having achieved design freeze we have moved the test into validation and verification to ensure we can manufacture the device in a robust and satisfactory manner. This work will be supported by external evaluation testing at HIV laboratories in Glasgow and London that, if successful, will allow us to commercialise the product.

The landscape for CD4 testing has changed over the past six months; amongst key opinion leaders and policy makers there has been a shift in the strategy for utilising CD4 testing in the care of people living with HIV. This has resulted in a series of regional workshops being held across the African continent that Omega Diagnostics has been invited to attend and participate in. The resulting output from these activities will see an increasing emphasis being placed on CD4 testing to help those people who present for care in the advanced stages of the disease with very low CD4 cell counts. This group of patients represents more than 30% of the overall HIV epidemic. In the advanced stages of HIV, patients are increasingly at risk of developing opportunistic infections that can dramatically reduce life expectancy. We are evaluating opportunities to bring other rapid tests to the market that will complement VISITECT(R) CD4 in helping public health practitioners combat HIV in low and middle-income countries.

In our efforts to make Omega Diagnostics a key supplier in the global health arena, we have worked hard over the past year to redefine our marketing materials with this audience in mind. In addition, we continue to develop simple but effective training tools that will benefit our customers who use our products in remote settings.

Outlook

Food intolerance continues to keep up its good performance and we expect to see this continuing in the year ahead with the strategic marketing initiatives being planned and executed as part of our accelerated growth strategy.

With renewed effort with regards to our ongoing relationship with IDS we are looking forward to the eventual launch of the initial range of CE-marked Allersys(R) tests. Expanding the test menu as currently envisaged will only help to increase sales of these products in the new financial year and beyond.

We are looking forward to reporting good sales progress over the coming year, together with our continuing goal of delivering VISITECT(R) CD4 to the market by the end of this calendar year.

I would like to thank all the Group employees who have made great efforts throughout the year in delivering progress in our core areas of activity. We are all looking forward to a year of growth and further progress.

Andrew Shepherd

Chief Executive

Financial review

Financial performance

Our core business recorded headline growth in revenue across all three divisions. Total revenue increased by 11.8% to GBP14.2 million (2016: GBP12.7 million), with both the Food intolerance division and the Allergy and autoimmune division recording double-digit revenue growth of 13.3% and 13.6% respectively. Food intolerance was supported by a strong growth in Foodprint(R) sales to GBP4.7 million (2016: GBP3.5 million), more than offsetting a reduction in sales of Food Detective(R) to GBP2.1 million (2016: GBP2.3 million) as some customers reduced stock levels. The Allergy and autoimmune division benefited from a growth in allergy sales in Germany to EUR3.6 million (2016: EUR3.4 million), offsetting a small reduction in autoimmune sales to GBP0.56 million (2016: GBP0.59 million). The Infectious disease division also recorded growth of 5.6% in revenue to GBP2.7 million (2016: GBP2.5 million). Revenue across all three divisions benefited by a combined GBP1.1 million (2016: GBP0.2 million) due to weaker sterling exchange rates following the country's decision in the EU referendum.

Gross profit increased by 13.3% to GBP9.2 million (2016: GBP8.1 million), helped by an increase in gross margin percentage to 64.7% (2016: 63.8%). Overheads increased by GBP0.8 million to GBP8.5 million (2016: GBP7.7 million). Administration costs have increased by GBP0.5 million, principally due to higher costs in the UK relating to undertaking a salary benchmarking exercise and implementing a more formal management training programme. Selling and marketing costs have increased by GBP0.3 million with a modest increase in costs in India and with the higher proportion occurring in Germany, where there has been a need to upskill in sales management. Other operating income reduced by GBP0.3 million on the prior year because that year included the final amortisation of a grant received from Unitaid in 2014.

Adjusted profit before tax (statutory profit before tax of GBP0.7 million with add backs for amortisation of intangibles, share-based payment charges and IFRS-related discount charges) was GBP1.1 million compared to GBP1.3 million the year before as the size of the add backs referred to above were lower by GBP0.2 million than in the previous year. Segmental performance as presented in the notes to the financial statements still shows that the Food intolerance division is the only profitable segment right now, but our plans to address the shortfall remain the same, with opportunities for Allersys(R) and VISITECT(R) CD4 as outlined throughout this Strategic Report.

Taxation

Our UK companies continue to benefit from government policies on tax that encourage investment in research and development activities. In the year, adjusted tax losses of GBP0.6 million for the year to 31 March 2016 were surrendered for cash at a rate of 14.5%, generating a cash rebate of GBP0.1 million. We still have cumulative tax losses of GBP2.9 million for years ended up to 31 March 2014 that are carried forward for future offset. The current-year tax credit of GBP0.1 million (2016: GBP0.1 million tax charge) reflects a lower level of losses surrendered in the year versus the prior year.

Earnings per share

Adjusted earnings per share were 1.1 pence versus 1.2 pence in the prior year. The difference is due mainly to the small reduction in adjusted profit before tax, as described above, leading to adjusted profit after tax of GBP1.19 million versus GBP1.26 million in the prior year, calculated on a fully diluted 109.8 million (2016: 109.5 million) shares in issue.

Research and development

As key development programmes continued to make progress, we increased investment in research and development to a total of GBP2.37 million (2016: GBP1.74 million), representing 16.6% of Group turnover. Expenditure on our Allersys(R) project increased to just under GBP1.1 million (2016: GBP0.95 million) as we completed the claim support work and compiled the technical file leading to CE-marking 41 allergens in October. Expenditure on VISITECT(R) CD4 also increased to GBP0.62 million (2016: GBP0.49 million) as we achieved design freeze of the product following the successful manufacture of three pilot batches.

We also incurred GBP0.3 million (2016: GBP0.1 million) on further developing our POC allergy dipstick test, Allergodip(R) , for use in doctors' offices. Other minor areas of expenditure included smaller projects covering food extract optimisation and completion of the malaria technology transfer into Pune, India. Of the total expenditure, GBP2.2 million (2016: GBP1.5 million) has been capitalised on the balance sheet in accordance with IAS 38 - Development Costs whilst earlier stage R&D expenditure of GBP0.2 million (2016: GBP0.26 million) has been expensed through the income statement.

Intangible assets

Intangible assets have increased to a total of GBP15.6 million (2016: GBP13.5 million), comprising goodwill of GBP4.7 million, separately identifiable intangible assets from previous acquisitions totalling GBP3.0 million and capitalised development costs of GBP7.9 million.

Goodwill

There has been no impairment of goodwill on any of the acquisitions to date. Goodwill of GBP4.7 million (2016: GBP4.6 million) has increased by GBP0.1 million relating to the retranslation of goodwill to GBP1.3 million (2016: GBP1.2 million) in acquiring the Allergy IVD business in Germany in 2010. GBP0.4 million arose on acquiring Co-Tek in 2009 and GBP3.0 million arose on acquiring Genesis/CNS in 2007.

Intangible assets

Separately identifiable intangible assets have been recognised in connection with past acquisitions: GBP2.0 million on Genesis/CNS, of which GBP1.0 million has been amortised to date; GBP0.1 million on Co-Tek, which has been fully amortised; and GBP1.7 million on Omega Diagnostics GmbH, of which GBP1.3 million has been amortised to date. A purchased licence of GBP1.5 million relates to the exclusive global access rights to the IDS-iSYS platform for allergy testing, which, to date, has not been amortised. Minor capitalised software costs amount to GBP0.1 million.

Capitalised development costs

Capitalised development costs of GBP2.2 million have been incurred in the year and, as described above, bring the cumulative spend to date on all projects to GBP7.9 million. A breakdown of the project expenditure is as follows:

 
                             2017        2016 
                              GBP         GBP 
---------------------  ----------  ---------- 
 Allersys(R)            5,069,499   3,995,021 
 VISITECT(R) CD4        2,221,480   1,597,367 
 Allergodip(R)            339,650      74,908 
 VISITECT(R) Malaria      109,431           - 
 Other                    132,191           - 
---------------------  ----------  ---------- 
 Total                  7,872,251   5,667,296 
---------------------  ----------  ---------- 
 

There has been no amortisation of these capitalised development costs in the years up to 31 March 2017 but the amortisation of these costs, along with the purchased licence referred to above, will only start after commercialisation of these assets. As stated on previous occasions, this particular subset of amortisation charges will not be added back in the computation of the Group's routinely reported adjusted profit before tax.

Property, plant and equipment

The Group maintained its expenditure on fixed assets at a similar level to last year at GBP0.6 million (2016: GBP0.6 million). The largest element included GBP0.3 million (2016: GBP0.1 million) invested in Alva to ensure continued compliance with overseas country regulatory audits and to equip the laboratory with the means to undertake protein purification and separation techniques in support of the Allersys(R) development programme. GBP0.2 million (2016: GBP0.2 million) was spent on Genesis/CNS to alleviate certain space constraints with the facility and GBP0.1 million (2016: GBPNil) was spent in Germany on laboratory equipment and instruments supplied on loan to the customer base.

Financing

The Group has a long-standing relationship with Bank of Scotland as principal bankers to the Group and, in May of this year, we agreed an overdraft renewal for an increased facility of GBP2.0 million (2016: GBP1.7 million) which is expected to revert to GBP1.7 million at the end of the first half of the new financial year. In addition to the overdraft, the bank provided an asset finance facility in the year of up to GBP1.0 million to fund the purchase of new plant and machinery. GBP0.2 million of this facility was drawn down in the year, repayable over five years, and the Company expects to roll over the balance for another year from the end of July 2017.

Operating cash flow

The Group monitors its cash requirement carefully and it is a key priority to manage working capital efficiently and to be effective in converting operating income into cash. Cash inflow from operating activities during the year was GBP2.01 million (2016: GBP1.45 million). The Group has achieved a conversion rate of adjusted operating profit (operating profit plus amortisation of intangible assets plus share-based payments) to operating cash of 171% (2016: 108%). We ended the year with cash reserves of GBP0.7 million (2016: GBP1.30 million) which means we were cash neutral in the second half of the financial year.

Foreign exchange

The Group has investments in overseas operations and conducts trading transactions in currencies other than sterling. The principal currencies used and the average foreign exchange rates in the year were as follows:

 
                        2017    2016 
                         GBP     GBP 
--------------------  ------  ------ 
 Sterling/US dollar     1.30    1.50 
 Sterling/euro         1.189   1.368 
 Sterling/Indian 
  rupee                87.18   98.22 
--------------------  ------  ------ 
 

Profit and loss account

The Group has foreign-denominated bank accounts to allow for the receipt and settlement of amounts in connection with its normal trading operations. These transactions are subject to timing differences between when they are transacted and when they are settled, which can give rise to foreign exchange differences. Foreign-denominated receivables, payables and bank balances are restated into sterling at closing balance sheet dates, which also gives rise to foreign exchange differences. During the year, the Group benefited from an exchange gain of GBP64,000 (2016: GBP6,000) on these transactions which has been credited through the income statement. The increase in the gain reflects the weakening of sterling generally following the EU referendum result as noted above.

Other comprehensive income

The Group has net assets in Germany and India, held in fully owned subsidiaries. The original investments in these subsidiaries are held at historic exchange rates. The difference between these historic balances and their restated amounts at the most recent closing balance sheet rates gives rise to movements which are recorded through other comprehensive income and carried as a balance sheet reserve. During the year, there has been a gain of GBP423,000 (2016: GBP261,000) on the retranslation of foreign operations of GBP315,000 in Germany and GBP108,000 in India.

Kieron Harbinson

Group Finance Director

Consolidated Statement of Comprehensive Income

for the year ended 31 March 2017

 
                                                     2017          2016 
                                                       GBP           GBP 
   Continuing operations 
   Revenue                                      14,246,930    12,743,896 
   Cost of sales                               (5,025,376)   (4,608,383) 
                                              ------------  ------------ 
 
   Gross profit                                  9,221,554     8,135,513 
   Administration costs                        (6,434,227)   (5,917,453) 
   Selling and marketing costs                 (2,124,203)   (1,821,068) 
   Other operating income                           31,636       272,769 
                                              ------------  ------------ 
 
   Operating profit                                694,760       669,761 
 
   Finance costs                                  (39,984)      (24,154) 
   Finance income - interest 
    receivable                                       1,450        16,225 
 
   Profit before taxation                          656,226       661,832 
 
   Tax credit / (charge)                            57,035      (89,920) 
 
   Profit for the year                             713,261       571,912 
 
   Other comprehensive income 
    to be reclassified to 
   profit and loss in subsequent 
    periods 
   Exchange differences on translation 
    of foreign operations                          423,478       260,960 
   Tax charge                                     (33,258)      (29,098) 
 
   Other comprehensive income that 
    will not be reclassified 
   to profit and loss in subsequent 
    periods 
   Actuarial (loss) / gain 
    on defined benefit pensions                  (107,948)       255,459 
   Tax credit / (charge)                            20,392      (47,533) 
                                              ------------  ------------ 
   Other comprehensive income 
    for the year                                   302,664       439,788 
 
   Total comprehensive income 
    for the year                                 1,015,925     1,011,700 
                                              ------------  ------------ 
 
   Earnings Per Share (EPS) 
   Basic and Diluted EPS on 
    profit for the year                               0.7p          0.5p 
 
   Adjusted Profit before 
    Taxation 
   For the year ended 31 March 
    2017                                              2017          2016 
                                                       GBP           GBP 
   Profit before taxation                          656,226       661,832 
   IFRS related discount charges                   (5,990)        17,793 
   Amortisation of intangible 
    assets                                         225,660       309,163 
   Share based payment charges                     254,834       362,327 
   Adjusted profit before 
    taxation                                     1,130,730     1,351,115 
                                              ------------  ------------ 
 
   Earnings Per Share (EPS) 
   Adjusted EPS on profit 
    for the year                                      1.1p          1.2p 
 

Consolidated Balance Sheet

as at 31 March 2017

 
                                          2017         2016 
                                           GBP          GBP 
 ASSETS 
 Non-current assets 
  Intangibles                       15,588,076   13,462,355 
  Property, plant and equipment      2,943,312    2,691,722 
  Deferred taxation                  1,651,945    1,426,205 
  Retirement benefit surplus                 -       44,759 
 
                                    20,183,333   17,625,041 
                                   -----------  ----------- 
 
 Current assets 
  Inventories                        2,377,575    2,011,495 
  Trade and other receivables        2,460,416    2,838,269 
  Cash and cash equivalents            737,331    1,302,257 
 
                                     5,575,322    6,152,021 
                                   -----------  ----------- 
 
 Total assets                       25,758,655   23,777,062 
                                   -----------  ----------- 
 
 EQUITY AND LIABILITIES 
 Equity 
 Issued capital                     16,727,516   16,727,516 
 Retained earnings                   4,753,190    3,905,909 
 Other reserves                       (22,770)    (446,248) 
 
 Total equity                       21,457,936   20,187,177 
                                   -----------  ----------- 
 
 Liabilities 
 Non-current liabilities 
  Long-term borrowings                 275,890      282,914 
  Deferred taxation                  1,811,110    1,537,560 
  Deferred income                      238,067            - 
  Retirement benefit deficit            57,199            - 
 
 Total non-current liabilities       2,382,266    1,820,474 
                                   -----------  ----------- 
 
 Current liabilities 
  Short-term borrowings                155,494      127,783 
  Trade and other payables           1,762,959    1,641,628 
 
 Total current liabilities           1,918,453    1,769,411 
                                   -----------  ----------- 
 
 Total liabilities                   4,300,719    3,589,885 
                                   -----------  ----------- 
 
 Total equity and liabilities       25,758,655   23,777,062 
                                   -----------  ----------- 
 

Consolidated Statement of Changes in Equity

for the year ended 31 March 2017

 
                                Share        Share    Retained   Translation 
                              capital      premium    earnings       reserve        Total 
                                  GBP          GBP         GBP           GBP          GBP 
 
 
 Balance at 31 March 
  2015                      5,086,756   11,640,760   2,792,842     (707,208)   18,813,150 
-------------------------  ----------  -----------  ----------  ------------  ----------- 
 
 Profit for the year 
  ended 31 March 2016               -            -     571,912             -      571,912 
 
 Other comprehensive 
  income - net                      -            -           -       260,960      260,960 
 exchange adjustments 
 
 Other comprehensive 
  income - actuarial 
 gain on defined benefit 
  pensions                          -            -     255,459             -      255,459 
 
 Other comprehensive 
  income - tax charge               -            -    (76,631)             -     (76,631) 
 
 Total comprehensive 
  income for the year               -            -     750,740       260,960    1,011,700 
 
 Share-based payments               -            -     362,327             -      362,327 
 
 Balance at 31 March 
  2016                      5,086,756   11,640,760   3,905,909     (446,248)   20,187,177 
-------------------------  ----------  -----------  ----------  ------------  ----------- 
 
 Profit for the year 
  ended 31 March 2017               -            -     713,261             -      713,261 
 
 Other comprehensive 
  income - net                      -            -           -       423,478      423,478 
 exchange adjustments 
 
 Other comprehensive 
  income - actuarial 
 loss on defined benefit 
  pensions                          -            -   (107,948)             -    (107,948) 
 
 Other comprehensive 
  income - tax charge               -            -    (12,866)             -     (12,866) 
 
 Total comprehensive 
  income for the year               -            -     592,447       423,478    1,015,925 
 
 Share-based payments               -            -     254,834             -      254,834 
 
 Balance at 31 March 
  2017                      5,086,756   11,640,760   4,753,190      (22,770)   21,457,936 
-------------------------  ----------  -----------  ----------  ------------  ----------- 
 

Consolidated Cash Flow Statement

for the year ended 31 March 2017

 
                                           2017          2016 
                                            GBP           GBP 
 
 Cash flows generated from 
  operations 
 Profit for the year                    713,261       571,912 
 Adjustments for: 
 Taxation                              (57,035)        89,920 
 Finance costs                           39,984        24,154 
 Finance income                         (1,450)      (16,225) 
---------------------------------  ------------  ------------ 
 
 Operating profit before working 
  capital movement                      694,760       669,761 
 Decrease / (increase) in 
  trade and other receivables           377,853     (298,418) 
 (Increase) / decrease in 
  inventories                         (366,080)        50,600 
 Increase in trade and other 
  payables                              121,331        99,569 
 Loss on sale of property, 
  plant and equipment                       813             - 
 Depreciation                           372,103       322,576 
 Amortisation of intangible 
  assets                                225,660       309,163 
 Movement in grants                     238,067     (271,269) 
 Share-based payments                   254,834       362,327 
 Taxation received                       91,983       209,367 
 
 Cash flow from operating 
  activities                          2,011,324     1,453,676 
---------------------------------  ------------  ------------ 
 
 
 Investing activities 
 Finance income                           1,450        16,225 
 Purchase of property, plant 
  and equipment                       (591,377)     (620,652) 
 Purchase of intangible assets      (2,068,960)   (1,418,536) 
 
 Net cash used in investing 
  activities                        (2,658,887)   (2,022,963) 
---------------------------------  ------------  ------------ 
 
 Financing activities 
 Finance costs                         (39,984)      (24,154) 
 New asset backed finance               163,000       104,566 
 Loan repayments                              -     (120,353) 
 Finance lease repayments             (142,313)     (126,734) 
 
 Net cash used in financing 
  activities                           (19,297)     (166,675) 
---------------------------------  ------------  ------------ 
 
 Net decrease in cash and 
  cash equivalents                    (666,860)     (735,962) 
 Effects of exchange rate 
  movements                             101,934        66,082 
 Cash and cash equivalents 
  at beginning of year                1,302,257     1,972,137 
 
 Cash and cash equivalents 
  at end of year                        737,331     1,302,257 
---------------------------------  ------------  ------------ 
 

Notes to the Preliminary Announcement

for the year ended 31 March 2017

1. Basis of preparation

The financial information set out in this preliminary announcement does not constitute statutory accounts as defined in Section 434(3) of the Companies Act 2006.

The consolidated balance sheet at 31 March 2017 and the consolidated statement of comprehensive income, consolidated cash flow statement, consolidated statement of changes in equity and associated notes for the year then ended have been extracted from the Group's financial statements which were approved by the Board of Directors on 29 June 2017 and are audited. The comparative consolidated financial information for the year ended 31 March 2016 is based on an abridged version of the Group's published financial statements for that year, which contained an unqualified audit report and which have been filed with the Registrar of Companies.

The statutory accounts for 2017 will be finalised on the basis of the financial information presented in this preliminary announcement and will be delivered to the registrar of companies following the company's annual general meeting.

The consolidated financial statements have been prepared in accordance with IFRS as adopted by the European Union as they apply to the financial statements of the Group for the year ended 31 March 2017.

Basis of consolidation

The Group financial statements consolidate the financial statements of Omega Diagnostics Group PLC and the entities it controls (its subsidiaries). Control is achieved when the Group is exposed, or has rights, to variable returns from its involvement with the investee and has the ability to affect those returns through its power over the investee. Subsidiaries are consolidated from the date of acquisition, being the date on which the Group obtains control, and continue to be consolidated until the date that such control ceases. The financial statements of the subsidiaries used in the preparation of the consolidated financial statements are based on consistent accounting policies. All intercompany balances and transactions, including unrealised profits arising from them, are eliminated.

Going concern

The Group has a committed overdraft facility of GBP2m provided by Bank of Scotland on 30 May 2017 for the period through to 30 September 2017 and firm indication of support received from the bank that they will renew the facility at 30 September 2017 for the period through to the end of June 2018 at a level of GBP1.7m. It is this firm indication of support from the bank that supports the director's conclusion to present the accounts on a going concern basis.

2. Segment information

 
                                   Allergy          Food   Infectious/ 
                                       and 
                                Autoimmune   Intolerance         Other     Corporate          Group 
 2017                                  GBP           GBP           GBP           GBP            GBP 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 
 Statutory presentation 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 Revenue                         3,679,068     9,439,233     2,827,986             -     15,946,287 
 Inter-segment revenue            (87,692)   (1,438,510)     (173,155)                  (1,699,357) 
 Total revenue                   3,591,376     8,000,723     2,654,831             -     14,246,930 
 Operating costs               (3,980,988)   (4,946,712)   (3,252,893)   (1,371,577)   (13,552,170) 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 Operating profit/(loss)         (389,612)     3,054,011     (598,062)   (1,371,577)        694,760 
 Net finance (costs)/income       (65,268)       (3,678)      (16,796)        47,208       (38,534) 
 Profit/(loss) before 
  taxation                       (454,880)     3,050,333     (614,858)   (1,324,369)        656,226 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 
 Adjusted profit 
  before taxation 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 Profit/(loss) before 
  taxation                       (454,880)     3,050,333     (614,858)   (1,324,369)        656,226 
 IFRS-related discount 
  charges                          (5,990)             -             -             0        (5,990) 
 Amortisation of 
  intangible assets                114,215        98,960        12,485             -        225,660 
 Share-based payment 
  charges                                -             -             -       254,834        254,834 
 Adjusted profit/(loss) 
  before taxation                (346,655)     3,149,293     (602,373)   (1,069,535)      1,130,730 
----------------------------  ------------  ------------  ------------  ------------  ------------- 
 
 
                                          Allergy and   Food          Infectious/ 
                                           Autoimmune   Intolerance         Other     Corporate          Group 
 2016                                             GBP           GBP           GBP           GBP            GBP 
 
 Statutory presentation 
 Revenue                                    3,254,725     8,681,553     2,698,113             -     14,634,391 
 Inter-segment revenue                       (95,693)   (1,621,862)     (172,940)             -    (1,890,495) 
---------------------------------------  ------------  ------------  ------------  ------------  ------------- 
 Total revenue                              3,159,032     7,059,691     2,525,173             -     12,743,896 
 Operating costs                          (3,479,086)   (4,572,482)   (2,768,799)   (1,253,768)   (12,074,135) 
---------------------------------------  ------------  ------------  ------------  ------------  ------------- 
 Operating profit/(loss)                    (320,054)     2,487,209     (243,626)   (1,253,768)        669,761 
 Net finance (costs)/income                  (58,283)       (2,137)      (21,625)        74,116        (7,929) 
---------------------------------------  ------------  ------------  ------------  ------------  ------------- 
 Profit/(loss) before taxation              (378,337)     2,485,072     (265,251)   (1,179,652)        661,832 
 
 Adjusted profit before taxation 
---------------------------------------  ------------  ------------  ------------  ------------  ------------- 
 Profit/(loss) before taxation              (378,337)     2,485,072     (265,251)   (1,179,652)        661,832 
 IFRS-related discount charges                      -             -             -        17,793         17,793 
 Amortisation of intangible assets            200,335        98,907         9,921             -        309,163 
 Share-based payment charges                        -             -             -       362,327        362,327 
 Adjusted profit/(loss) before taxation     (178,002)     2,583,979     (255,330)     (799,532)      1,351,115 
---------------------------------------  ------------  ------------  ------------  ------------  ------------- 
 
 
 
 
 3. Revenues 
 
                                 2017         2016 
                                  GBP          GBP 
-------------------       -----------  ----------- 
 
 UK                           978,154      939,635 
 Germany                    2,989,268    2,667,102 
 Rest of Europe             3,557,085    3,513,511 
 North America              1,653,797    1,098,320 
 South/Central 
  America                   1,005,505      874,151 
 India                        616,070      548,837 
 Asia and Far 
  East                      1,496,692    1,480,638 
 Africa and Middle 
  East                      1,950,359    1,621,702 
 
                           14,246,930   12,743,896 
     -------------------  -----------  ----------- 
 

4. Finance costs

 
                                 2017          2016 
                                  GBP           GBP 
---------------------------   -------  ------------ 
 
 Interest payable on loans 
  and bank overdrafts          20,039         3,104 
 Finance leases                19,945        21,050 
 
                               39,984        24,154 
                              -------  ------------ 
 

5. Tax credit/(charge)

 
                                                                     2017         2016 
                                                                      GBP          GBP 
----  ---------------------------------------        --------  ----------   ---------- 
 Tax credit/(charge) in the 
  income statement 
 Current tax - prior 
  year adjustment                                                  91,980      209,368 
 Deferred tax - current 
 year                                                              49,223      132,794 
 Deferred tax - prior 
  year adjustment                                                (84,168)    (432,082) 
 
                                                                   57,035     (89,920) 
  ------  ----------------------------------  -----  --------  ----------   ---------- 
 Tax relating to items charged or credited 
  to other comprehensive income 
 Deferred tax on actuarial 
  loss/(gain) on 
  retirement benefit 
  obligations                                                      20,392     (47,533) 
 Deferred tax on net 
  exchange adjustments                                           (33,258)     (29,098) 
 
                                                                 (12,866)     (76,631) 
  ------  -----------------------------------  -----  -------  ----------   ---------- 
 
 
 
 
 Reconciliation of 
  total tax charge 
 Factors affecting the tax 
  (credit)/charge for the 
  year: 
 Profit before tax                                         656,226      661,832 
--------------------------------------------------------  -----------  ---------- 
 
 Effective rate 
  of taxation                                              20%          20% 
 
 Profit before tax multiplied 
  by the effective rate of tax                             131,245      132,366 
 
 Effects of: 
 Expenses not deductible for tax purposes 
  and permanent differences                                66,377       76,734 
 Research and development 
  and deferred tax credits                                 (111,354)    (250,622) 
 Tax repayment on surrender of 
  tax losses in prior year at 14.5%                        (91,980)     (209,368) 
 Tax losses surrendered in prior 
  year at 20%                                              126,869      288,783 
 Tax (overprovided)/under provided 
  in prior years                                           (42,703)     143,299 
 Adjustment due to different overseas 
  tax rate                                                 (70,690)     (59,975) 
 Impact of UK rate change on deferred 
  tax                                                      (64,799)     (31,297) 
 Tax (credit)/charge 
  for the year                                             (57,035)     89,920 
-------------------------------------------  -----        -----------  ---------- 
 
 

6. Earnings per share

Basic Earnings per share are calculated by dividing net profit for the year attributable to ordinary equity holders of the Group by the weighted average number of ordinary shares outstanding during the year.

Diluted earnings per share are calculated by dividing the net profit attributable to ordinary equity holders of the Group by the weighted average number of ordinary shares outstanding during the year plus the weighted average number of ordinary shares that would be issued on the conversion of all the dilutive potential ordinary shares into ordinary shares. Diluting events are excluded from the calculation when the average market price of ordinary shares is lower than the exercise price.

 
                                              2017      2016 
                                               GBP       GBP 
---------------------------------------   --------  -------- 
 
 Profit attributable to equity holders 
  of the Group                             713,261   571,912 
----------------------------------------  --------  -------- 
 
 
 
                                               2017          2016 
                                             Number        Number 
------------------------------------   ------------  ------------ 
 
 Basic average number of shares         108,745,669   108,745,669 
 Share options                            1,013,126       780,017 
 
 Diluted weighted average number of 
  shares                                109,758,795   109,525,686 
-------------------------------------  ------------  ------------ 
 

Adjusted Earnings per share on profit for the year

The Group presents adjusted earnings per share which is calculated by taking adjusted profit before taxation and adding the tax credit or deducting the tax charge in order to allow shareholders to understand better the elements of financial performance in the year, so as to facilitate comparison with prior periods and to assess better trends and financial performance.

 
                                                 2017        2016 
                                                  GBP         GBP 
----------------------------------------   ----------  ---------- 
 
 Adjusted profit before taxation            1,130,730   1,351,115 
 Tax credit/(charge)                           57,035    (89,920) 
 
 Adjusted profit attributable to equity 
  holders of the Group                      1,187,765   1,261,195 
-----------------------------------------  ----------  ---------- 
 

7. Annual General Meeting

The Annual General Meeting will be held at Omega House, Hillfoots Business Village, Clackmannanshire, FK12 5DQ on 29 August 2017 at 11am.

8. Annual Report

The annual report will be sent to shareholders on 12 July 2017 and will also be available at the registered office of Omega Diagnostics Group PLC at:

One London Wall, London, EC2Y 5AB

and will be made available on the Company's website at:

www.omegadiagnostics.com

This information is provided by RNS

The company news service from the London Stock Exchange

END

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June 30, 2017 02:01 ET (06:01 GMT)

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